Patient Safety in the OR 5Th Edition

The OR Management Series

Patient Safety in the OR 5th Edition

A compilation of articles from OR Manager

Editor Elizabeth Wood Editor, OR Manager

Clinical Editor Judith M. Mathias, MA, RN Clinical Editor, OR Manager

Contributor Cynthia Saver, MS, RN President, CLS Development Inc, Columbia, Maryland

All rights reserved. No part of this book may be reproduced in any form or by any means, electronic or mechanical, including photocopying or by an information storage and retrieval system, without permission from the publisher. Publisher Access Intelligence, LLC 4 Choke Cherry Rd, 2nd Floor Rockville, MD 20850

Library of Congress Catalog Card Number: 2011937405

ISBN: 978-0-9914473-3-6

Printed in the USA

2 The OR Management Series Patient Safety in the OR Foreword

his update of the 2011 Patient Safety in improvement approach after safety failures, the OR reflects an ever-greater emphasis and they note that organizations using this T on processes and standards aimed at im- approach have seen impressive reductions in proving outcomes. We’ve included 15 articles surgical site infections and ineffective handoffs. from 2012 and 25 from 2013, along with 5 articles published thus far in 2014. Implementation of the Affordable Care Act is shifting the emphasis to greater collaboration Every issue of OR Manager includes ar- and coordination among healthcare providers. ticles related to patient safety because almost Those themes are also explored in our patient everything done in the perioperative environ- safety articles, along with new approaches to ment is related to patient safety. We have kept age-old problems common in many ORs. readers apprised of the latest regulatory and compliance standards, recalls, safe sterilization This latest edition of Patient Safety in the OR practices, protocols for avoiding surgical site offers timely, relevant articles that can serve as infections and readmissions, preoperative and a reference for OR administrators, periopera- postoperative best practices, and advances in tive directors, and their staffs as they strive to surgical techniques, to name just some of the make their facilities and processes safer for topics we cover. their patients.

Earlier this year we reported on the South Carolina Safe Care Commitment project as one example of an organization striving to meet the high reliability standards put forth by the Joint Commission in late 2013. The authors of that report (“High Reliability Health Care: Getting Elizabeth Wood There from Here”) advocate a robust process Editor, OR Manager

Patient Safety in the OR The OR Management Series 3 4 The OR Management Series Patient Safety in the OR Table of Contents

I. General...... 7 A safer, faster way for postoperative x-rays...... 8 A steep price to pay: Fatigue compromises staff and patient safety...... 9 Blood management: Reducing blood use reduces risks and lowers costs...... 12 Capnography: New standard of care for sedation?...... 17 Early action advisable to prepare for new alarm safety standards...... 21 Fast action, team coordination critical when surgical fires occur...... 25 FDA issues Unique Device Identification final rule...... 28 Joint Commission targets fatigue from clinicians’ extended hours...... 30 Malignant hyperthermia: A crisis response plan...... 31 Raising the bar for safety in the handling of surgical specimens...... 35 Safety, cost savings, simplicity back broader use of bloodless surgery...... 38 Solid OR governance is the foundation for safety...... 41 Stryker’s Neptune recall raises stakes for compliance...... 44 Trauma center’s mortality rate drops dramatically with use of new protocols...... 46

II. Handoffs, Briefings, Checklists, Time-outs...... 49 A cure for the distracted time-out before surgery...... 50 Adopting a ‘no interruption zone’ for patient safety...... 53 Has your checklist effort stalled? Some advice on how to restart it...... 56 Implementing a daily huddle protects patients, avoids delays...... 60 Lack of surgical checklist compliance suggests need to improve implementation...... 62 OR debriefings put the safety checklist ‘on steroids’...... 63 Preoperative practices overhauled after surgical checklist failure...... 66 Team participation and planning produce quality handoffs...... 68 Team training, checklist equal better outcomes in pilot...... 73

III. High Reliability...... 75 Rounding tool off to a good start in improving patient satisfaction...... 76 South Carolina models high reliability standards through pilot program...... 79 Targeted Solutions Tool helps banish communication barriers during surgery...... 82

IV. Preventing Infections...... 85 Are you on target for meeting SSI, SCIP metrics?...... 86 Curbing OR traffic: Finding ways to minimize the flow of personnel...... 88 Joint project targets prevention for colorectal surgical infections...... 91 Have you taken steps to avoid the abuse of IUSS?...... 93 Hospitals share data to prevent colorectal SSIs...... 96 New AORN recommendations focus on infection prevention, patient safety...... 99 ‘Operation Zero’ targets surgical site infections...... 103

Patient Safety in the OR The OR Management Series 5 Preventing SSIs: Keys to solutions lie with your front-line clinicians...... 106 Safer surgery: Six steps that aim for excellence in sterile processing...... 110 Scope storage: Don’t get hung up on a number...... 113 Spore test for liquid chemical sterilant processing system...... 116 Taking control of implant processing practices...... 118 Unprocessed tray incident prompts investigation, leads to process improvements...... 121

V. Preoperative Screening...... 123 Preoperative screening program reveals missed diagnoses and reduces mortality...... 124 Safer surgery: The preoperative testing process...... 126 Why are there so many unneeded preop tests?...... 128

VI. Retained Surgical Items...... 129 Focus shifts to device fragments, small miscellaneous items in RSIs...... 130

VII. Wrong Patient, Wrong Surgery, Wrong Site...... 133 A clearer, more robust surgical consent process...... 134 ‘Just Culture’ encourages error reporting, improves patient safety...... 135

6 The OR Management Series Patient Safety in the OR I. General

Patient Safety in the OR The OR Management Series 7 A safer, faster way for postoperative x-rays

ith patient safety as its primary goal, • The radiology technologist assigned to the OR the University of Michigan Health Sys- is paged and goes to the OR as soon as possible. Wtem has created a new process using • All x-ray images are digital and are sent imme- bar-coded sponges and electronic radiology or- diately to the PACS [picture archiving and com- ders to ensure no items are unintentionally left munication system], where they can be viewed. in a patient during surgery. Electronic orders • After the x-ray is read, the radiologist calls di- provide for a standardized process that not only rectly into the OR and talks with the surgeon on is safer but also saves 15 to 20 minutes in OR time. speaker phone rather than writing the result on “Having a surgical item left in the patient is paper that is faxed or hand carried to the OR. something that should never happen,” says Ella Kazerooni, MD, MS, professor of radiology and Standardized order associate chief of radiology. A benefit of the automated system is a stan- “Unfortunately, in complex and emergency dardized x-ray order that requests specific infor- cases, in particular, or in larger patients, items are mation: the type of surgery, what item is being more likely to be left behind, and we want to do looked for, and the phone number of the OR. everything we can to prevent that.” “The electronic order accomplished several Collaboration is key things,” says Dr Kazerooni. “It gets the request to Though recognizing there was technology that radiology quickly, it relays the correct informa- could assist in preventing a retained item, “we also tion so the radiologist knows specifically what to recognized that technology alone isn’t the answer,” look for, and it gives a specific number to call with says Shawn Murphy, MS, BSN, RN, CNOR, director the x-ray findings.” of nursing OR/PACU and associate hospital admin- The previous paper order only requested an intra- istrator. Also important, she says, were collaborative operative x-ray to rule out a foreign body. Radiolo- relationships, team building, standard work pro- gists often didn’t know what foreign body they were cesses, education, and comprehensive policies. looking for or exactly where, says Dr Kazerooni. The U-M Health System, with 27 ORs, uses bar- She estimates the electronic order process coded sponges (SurgiCount Safety-Sponge System, saves 15 to 20 minutes of OR time, which reduces Irvine, California), which are scanned before the the time a patient is under anesthesia, helps re- sponges are added to the sterile field and when duce delays, and decreases OR time charges. they come off. The sponges have radiopaque tags Saving OR time that allow them to be seen on an x-ray. A previous obstacle to x-rays before elec- “The bar-coded sponge system can alert the tronic orders were introduced was that surgeons surgical team to a sponge that is not accounted thought the process took too long and weren’t for, but an x-ray is still needed to determine if willing to wait for x-ray results before closing the that sponge remains in the patient,” says Murphy. incision or moving the patient from the OR. Automating radiology orders “We had to prove we could turn this around “Our top challenge in radiology was to speed up quickly so we could add value to their work flow the process of taking an x-ray and communicating and patient care. results to the surgical team,” says Dr Kazerooni. “We did that, and now they don’t have to wait Steps in the automated ordering process include: long to get the information they need while the patient is still in the OR,” says Dr Kazerooni. ❖ • When the OR team finds a sponge, instrument, —Judith M. Mathias, MA, RN or needle is missing, the circulating nurse enters an order for an x-ray in the hospital’s Access a video about the U-M process to prevent re- computerized order entry system. tained surgical items. • The order shows up immediately in the elec- http://www.uofmhealth.org/news/retained-surgical- tronic work queue in the radiology depart- items-0206 ment. The circulating nurse no longer has to fill out a requisition, call radiology, or have This article originally appeared in OR Manager, someone deliver the order to radiology. July 2012;28:21.

8 The OR Management Series Patient Safety in the OR A steep price to pay: Fatigue compromises staff and patient safety

t’s not uncommon for nurses to work 3 12- Does your OR department hour shifts at 1 hospital and then work another I3 at a different hospital, yet anyone who works use 12-hour shifts? 12 hours is putting their patients in jeopardy, Yes 49% Sheryl A. Michelson, MS, RN-BC, said at the AORN Congress in March 2013. No 51% “This is not what nurses want to hear, but we need to think about this. We didn’t go into nursing to hurt people,” Michelson said during a What are 12-hour shifts compelling presentation on worker fatigue. used for? “When we allow people to work 6 12-hour Weekdays only 38% shifts in a row, we are pretty much signing their death certificate or maybe someone else’s in the Weekends and holidays 4% community who gets hit by the person driving only home,” Michelson told a packed audience. A combination of the 58% Having known 2 nurses who died from falling asleep at the wheel after working long shifts, above Michelson is highly attuned to the dangers of auto accidents. “One was a very dear friend of mine. She left 3 young children, and it had a huge “we don’t force people to do 24-, 48-, or 72-hour impact on me,” she said. call shifts, but many places do that,” she said. As the manager of perioperative education at Some people take long hours voluntarily, and oth- Stanford University Hospital in Stanford, Cali- ers are being mandated to do so because of how fornia, Michelson is on call every fourth or fifth their hospital schedule is run. “They don’t feel weekend, working from 3 pm Friday until Mon- that they have the ability to say ‘this is not safe,’” day morning as the administrative manager. Over Michelson said. time, she has noticed an increase in complaints about staff behavior among people working long Fallout from fatigue shifts, such as lack of teamwork, yet she also Safety risks increase after working 8 hours, found more staff were requesting more hours. so working 10- or 12-hour shifts significantly in- Michelson, a member of Stanford’s needle- creases the risk that nurses will harm themselves stick injury committee, sought to learn the as- or their patients, according to Michelson. sociation between injury incidence and length of “Sleep duration is linked to metabolism and shift. Through an extensive literature search, she appetite regulation. Glucose tolerance is altered learned some startling facts about the effects of by short-term sleep restriction, so even being fatigue: $18 billion per year is lost in productiv- sleep-deprived just 1 or 2 days a week raises the ity and accidents (among nurses and other shift risk of being overweight or prediabetic,” Michel- workers such as fire fighters and the police), and son said, adding that at least one-third of the at- there are at least 1,500 fatalities, 100,000 auto tendees in the room were likely diabetic. crashes, and 76,000 injuries annually. Other risks associated with sleep deprivation It’s important to know that fatigue constitutes include a higher likelihood of injury, preterm overwhelming tiredness and impaired cognitive birth, and rate of accidents. In a small study of 45 and physical function, she said. Nurses will admit ICU nurses working 12-hour shifts, she said, all to feeling exhausted, but they don’t know when but 2 staff members surveyed admitted to having they are dangerous. Often, it’s not until a major had an auto accident in the previous 12 months. error occurs that people realize how much fatigue In a study of 47,000 nurses, 54% admitted to affects their performance. In one study, among being impaired in some way from fatigue during 22,000 RNs who rotated shifts, 35.5% admitted to a 28-day period. Inadequate rest is also linked falling asleep while caring for patients. to moodiness, cognitive problems, reduced job At Stanford, an academic institution with more performance and motivation, depression, worse than 600 beds that treats mainly adult patients, hand-eye coordination, and decreased memory.

Patient Safety in the OR The OR Management Series 9 Research defines dangers of shift work sleep disorder The combination of 12-hour shifts and call can be lethal. That may be 1 reason why more than half (51%) of surgical services directors don’t use 12-hour shifts, according to the 2013 OR Manager Salary/Career Survey. For those who do use 12-hour shifts, most respondents use them for weekdays, weekends, and holidays (58%); but slightly more than a third (38%) use them only for weekdays, and just 4% use them only for weekends and holidays. Even if you don’t have 12-hour shifts in your OR, you may have part-time employees who are working these shifts elsewhere, and taking call can easily disrupt normal sleep cycles. OR leaders must be aware of the potential problem of sleep disturbances, including shift work sleep disorder (SWSD). Employees with SWSD have a difficult time staying awake when working the night shift even if they had sufficient sleep before the shift. They may also have difficulty getting to sleep during the daytime, sleep too much during the day, or have difficulty waking up to go to work at night.

SWSD dangers Jeanne Geiger-Brown, PhD, RN, FAA, associate professor and assistant dean for research at the University of Maryland School of Nursing, says her sleep research has identified 4 primary areas of neurocognitive changes with SWSD: performance deficits such as not performing a task as well as when rested; impaired information processing such as decline in short-term memory and reduced ability to learn; cognitive flexibility, which results in faulty risk assessments and less ability to recognize better alternatives; and impaired mood, including anxiety, depression, and decreased communication skills. These deficits not only can lead to patient harm but may cause the employee personal physical harm (through accidental needlesticks or falling asleep at the wheel of a car) and may adversely affect interpersonal relationships. Unfortunately, people may not be aware of the danger. “Research has shown that with repeated days of not getting enough sleep each night, vigilant performance gets worse and worse, but a sleep-deprived person doesn’t have a parallel increase in sleepiness, so they can have a false impression that they aren’t as impaired as they actually are,” Geiger-Brown says. People at risk for SWSD include women, older individuals, and those working in health care. “Most nurses are women, have an average age of 46, and are working in health care, so it’s not surprising they’re at risk for SWSD,” says Kathryn Lee, PhD, RN, FAAN, CBSM, professor and associate dean for research at the University of California at San Francisco School of Nursing. An experienced sleep researcher, Lee adds that other risk factors include an anxious personality and lack of internal locus of control. Although it relies on subjective responses, the Epworth Sleepiness Scale can be helpful in identifying how much the disrupted sleep is affecting the shift worker.

SWSD solutions It’s vital to help employees find relief from SWSD. Although correlation doesn’t imply causation, it’s worth noting the night shift has been associated with an increased risk of breast cancer, vascular disease, metabolic syndrome, irregular menstrual cycles, lower birth weight infants, and diabetes. The most common complaints are gastrointestinal symptoms such as irritable bowel syndrome and abdominal pain. Managing SWSD includes better sleep hygiene (see main article). In some cases, treatment with modafinil or armodafinil may be necessary. To learn more about SWSD in staff (and in patients), access “Shiftwork Sleep Disor- der: The Role of the Nurse, Understanding SWSD for You and Your Patients” at http:// www.americannursetoday.com/Article.aspx?id=10218&fid=9534. Access a tool kit about sleep disorders at http://eo2.commpartners.com/users/swsd/. —Cynthia Saver, MS, RN

10 The OR Management Series Patient Safety in the OR Strategies to catch some z’s To the dismay of many in the audience, she Sleeping in a darkened, cool room, napping advised using it only at work and never at home and exercising in a timely manner, and using caf- because drinking caffeine routinely will diminish feine appropriately are some ways nurses can get its effectiveness. better sleep. And studies support the benefits of Likewise, she noted that exercise helps people working shorter shifts, even though this is not a sleep better, but it must be carefully timed; it’s popular option, she said. better to exercise after a shift than before going Among the changes Michelson suggested are to to work. avoid scheduling people for more than 2 or 3 consec- What’s next? utive night shifts and allow 10 to 12 hours of recovery When asked whether she thought the Joint time between shifts. The airline industry has altered Commission would mandate changes to shifts, pilots’ schedules to increase safety, she noted, and the Michelson said the Commission has mandated that health care industry should do likewise. institutions begin taking some responsibility and In 2011, following a deadly plane crash, the look at how they are attempting to mitigate worker Federal Aviation Administration instituted new fatigue. “Hospitals will be hard-pressed to justify rules about the number of consecutive hours pi- letting people work 24-hour shifts,” she said. lots are allowed to fly, including a 30-hour period As these changes evolve, nurses will have each week when they must not work. The airlines to take call on days when they’re not working require annual training on topics such as nutri- because they won’t be allowed to take call after tion, exercise, and sleep disorders, she added. their regular shifts, and it may be necessary The average RN gets 25.7 minutes of break to hire additional full-time employees. But during a shift, and nurses who work longer shifts Michelson stressed that nurses can be proac- tend to get shorter breaks than those who work tive and try to adjust their schedules before shorter shifts. Studies have shown that short anything is mandated. ❖ naps lasting less than 45 minutes are effective at —Elizabeth Wood restoring energy and alertness, she said—so it’s important to take a break and sleep for a short period, if possible. Caffeine (at least 200 mg) can be helpful if it’s consumed 15-30 minutes before starting a shift or during the period between 3 am and 5 am when This article originally appeared in OR Manager, people tend to get very sleepy. September 2013;29:11-13.

Patient Safety in the OR The OR Management Series 11 Blood management: Reducing blood use reduces risks and lowers costs

t’s common for physicians to order 2 units The restrictive group had lower overall 30-day of blood. But with growing awareness of the mortality (18.7% vs 23.3%) and lower in-hospital Ihazards of transfusions, hospitals are adopting mortality (22.2% vs 28.1%). stricter measures to manage their blood supplies, “The TRICC study showed that a hemoglobin including developing guidelines for transfusions trigger of 7 was not only as effective but superior and making sure physicians are compliant. to a trigger of 10,” says Thomas, adding that “the Over the past 5 years, research has shown hemoglobin trigger of 10 is antiquated and not that transfusions during surgery carry risks of based on any evidence.” It dates to 1942 when a higher mortality, surgical site infections, and prominent anesthesiologist from the Mayo Clinic other complications. promoted the idea that patients would have a A federal panel on use of blood products found better recovery if their hemoglobin levels were too many patients are receiving blood transfusions maintained above 10 g/dL. they don’t need, putting them at risk, wasting lim- The TRICC study is still viewed as the one hav- ited blood resources, and raising costs. ing the greatest impact on transfusion practice, says The Health and Human Services Advisory Com- Thomas. Prior to this study, practitioners based mittee on Blood Safety and Availability issued find- transfusion decisions on retrospective studies that ings and recommendations in June 2011 (sidebar). found patients had adverse effects due to anemia. One finding was that blood management programs have shown a significant reduction in Federal panel findings blood use without patient harm. Also in June, the Joint Commission issued its Recognizing the role of transfusion prac- final Patient Blood Management Performance tices in quality and costs, the HHS Ad- Measures, which provide metrics hospitals can visory Committee on Blood Safety and use to gauge how they are meeting blood man- Availability in June 2011 found: agement goals (sidebar). • blood transfusions carry significant risks Accelerating interest that may outweigh their benefits and add unnecessary costs “What really accelerated the interest in blood management was evidence coming out of the • wide variability in use of transfusions in- critical care literature, including the 2009 clinical dicates both excessive and inappropriate practice guideline on transfusions from the Soci- use of blood transfusions in the US ety of Critical Care Medicine and Eastern Associa- • medical advances and an aging population for the Surgery of Trauma,” Joseph Thomas, tion are expected to raise transfusion de- BSN, RN, told OR Manager. mands that could exceed supplies in 1 to 2 This was the first formal practice guideline to decades recommend single-unit transfusions rather than 2 • improvements in the quality and safety of units for nonhemorrhaging patients, says Thomas, blood have lagged behind improvements vice president of program services for the Strategic in rational use of blood Healthcare Group, LLC, a blood management con- • additional data on blood use and clinical sulting firm (www.bloodmanagement.com). outcomes are needed to manage transfu- An antiquated trigger sions effectively and support evidence- The first prospective randomized controlled based practices clinical study on blood transfusions, Transfusion • hospital blood management programs Requirements in Critical Care (TRICC), was not have demonstrated significant reduction published until 1999. The study compared out- in blood use without increase in patient comes in patients transfused with red cells when harm. hemoglobin concentrations dropped below 7 g/ www.hhs.gov/ash/bloodsafety/adviso- dL (restrictive group) and those transfused when rycommittee/recommendations/recom- hemoglobin concentrations dropped below 10 g/ mendations_201106.pdf dL (liberal group).

12 The OR Management Series Patient Safety in the OR In the trial, rates of death or inability to walk Joint Commission without human assistance at 60-day follow-up measures were similar in patients randomized to a liberal transfusion threshold (hemoglobin 10 g/dL) New Patient Blood Management Perfor- and to a more restrictive transfusion strategy mance Measures: (hemoglobin <8 g/dL or symptoms of anemia). • PBM-01 Transfusion consent Differences were not significant in rates of in- hospital acute myocardial infarction, unstable • PBM-02 RBC Transfusion indication angina, or death. Rates of other complications • PBM-03 Plasma transfusion indication also were similar. • PBM-04 Platelet transfusion indication Cost a factor • PBM-05 Blood administration documentation Besides patient safety and quality, cost is • PBM-06 Preoperative anemia screening another driving factor for managing blood trans- • PBM-07 Preoperative blood type testing fusions. Blood is expensive, easily ranging from and antibody screening. $1 million to $10 million per year for acquisition alone, notes Thomas. www.jointcommission.org/patient_blood_ “Blood is a limited resource. It is a waste of management_performance_measures_project/ blood and dollars to continue ordering and trans- fusing 2 units of blood when 1 will do,” Nicole Brocato, MSN, MBA, RN, told OR Manager. She is executive director of quality improvement and “Everyone had just assumed that if anemia has clinical research at John Muir Health. some risk, they should prevent an adverse event Brocato explains that it costs $200 to $300 to from potentially happening by giving blood to acquire a unit of blood and $650 to administer it. correct the anemia. No one ever asked wheth- John Muir Health, a 2-hospital health system in er patient outcomes improved when they were Concord and Walnut Creek, California, had an transfused,” he says. escalating blood budget of $6 million a year. Over the past 5 years, the number of studies has grown (sidebar). Blood management program A study, published online December 14, 2011, Over 3 years from 2007 to 2009, John Muir in The New England Journal of Medicine, provides saved more than $2.9 million by implementing new evidence that a more restrictive transfusion a blood management program that focused on: threshold is appropriate, including in elderly • a new hospital policy of physicians ordering 1 patients with cardiovascular risks. The study also unit of blood at a time instead of 2 units helps confirm that the findings of the TRICC trial apply to patients outside the ICU. • lowering the transfusion trigger of hemoglobin

An eye-catching poster reminds clinicians to get on board with single-unit blood transfusions.

Patient Safety in the OR The OR Management Series 13 Evidence on transfusions ■ The first prospective randomized controlled study of transfusion in cardiac Evidence is causing concern about blood surgery was published in 2010. The transfusion. Transfusion Requirements after Cardiac Surgery (TRACS) study found patients Key reports treated under stricter guidelines for use ■ In a 2009 study analyzing 125,000 pa- of red blood cell transfusions in cardiac tients in the National Surgical Qual- surgery had similar rates of morbidity ity Improvement Program (NSQIP) and mortality as patients who received database, intraoperative transfusion of more transfusions. 1 to 2 units of packed red blood cells —Hajjar L A, Vincent J L, Galas F R, et al. was associated with increased 30-day JAMA. 2010;304:1559-1567. mortality, surgical site infections, pneumonia, and sepsis in general surgery ■ Another study tracked more than patients. Decreasing blood transfusions 100,000 Medicare patients who had decreased patient morbidity. coronary artery bypass graft surgery. There was a statistically significant A wide variation was found in blood difference in infection rates with just 1 transfusions without a large difference unit of blood. It was worse when 2 units in the rate of deaths, suggesting many were given, after correcting for patient transfusions may be unnecessary. variables. —Bernard A C, Davenport D L, Chang P K, —Bennett-Guerrero E, Zhao Y, O’Brien S et al. J Am Coll Surg. 2009;208:931-937. M, et al. JAMA. 2010;304:1568-1575.

concentrations of 10 g/dL to 7 g/dL. Presently, tion rates, and each unit is a different liquid tissue the physicians are using a trigger of between 8 transplant that should be treated with respect. g/dL and 7 g/dL. Autologous blood collected a week or two before More than $900,000 was saved the first year, surgery is not completely safe either, he says. Any more than $1 million was saved the second year, biological substance stored in a refrigerator changes and the savings have been sustained. its properties. Every day blood is stored there is a The savings don’t include the reductions in buildup of cytokines, plasma-free hemoglobin, potas- labor, supplies, testing, or adverse events but sium, and cellular debris, which promotes inflamma- simply the amount paid to the local blood pro- tion. Red cells stored over time become sticky and vider, says Thomas, who worked with John Muir inflexible and less able to perfuse the capillaries. on the project. Thomas says he also points out to physicians John Muir started its blood management pro- that the 2 units of blood they automatically order gram for its cardiac surgery service in 2007 after and give are not just 1 large unit split in half; each exceeding the Society of Thoracic Surgeons blood unit is completely different. He advises them that transfusion benchmark. they can as easily give 1 unit and reassess the pa- The program is now systemwide. The cost tient before giving a second. savings have been a secondary but welcomed “It’s not about avoiding transfusion; it’s about outcome. minimizing exposure to a potentially harmful Thomas says his firm consistently achieves substance,” he says. 20% to 40% reductions in blood use in hospitals As part of raising awareness, Thomas uses they work with. creative reminders, such as screen savers that say, “Why give 2 when 1 will do?” and posters Changing habits showing animals entering Noah’s Ark 2-by-2. At Many physicians have become more comfort- the end of the line is a single unit of blood say- able in the hemoglobin 8 g/dL range, but most ing, “Two-by-two was good for Noah, but not for have not reached the 7 g/dL range except for criti- blood transfusions. Get on board with single-unit cal care physicians, says Thomas, noting that 8 g/ transfusions; don’t flood your patient.” dL is still an improvement. The bigger challenge has been convincing physicians to order 1 unit of Transfusion committee blood instead of 2. Integral to John Muir’s success was the forma- “It’s not because of a lack of information. It’s tion of a transfusion committee. The committee just such an engrained habit,” says Thomas. appointed a transfusion safety officer, identified a At John Muir, the change began by having physician champion, and developed an education round-table discussions with the physicians and plan and new transfusion order form. showing them the data. He emphasized that Three core people are needed to make a blood every unit of blood increases a patient’s complica- management program work, Brocato notes:

14 The OR Management Series Patient Safety in the OR John Muir Transfusion Order Form

*1ORD* 1ORD

Check one: Routine STAT, specify product if not all products needed STAT OR (surgery date) Minimal effective dose of all blood components should be used

Use Normal Saline 500 ml for priming IV tubing for transfusions Premeditations : Acetaminophen (Tylenol) 650 mg PO x 1 dose Diphenhydramine (Benadryl) 25 mg 50 mg PO or IV x 1 dose # units Please check off at least one indication for each type of blood component order Packed Red Cells, transfuse over hours or 2-3 hours per unit. (Cannot exceed 4 hr from time of blood bank release) Irradiated; specify justification SINGLE UNIT transfusions are often effective. Recheck Hct/Hgb after one unit of packed red cells One unit of packed red cells in an adult will increase Hct by 3%, Hgb by 1g/dL. Most recent hemoglobin g/dL or hematocrit % Date Indication: Rapid blood loss: ongoing blood loss or potential for life-threatening blood loss Hematocrit ≤ 21% or Hemoglobin ≤ 7 g/dL Patient normovolemic but demonstrates evidence of impaired O2 carrying capacity as indicated by: Tachycardia, hypotension, shock not corrected by adequate volume replacement alone Other (please specify)

Platelet Pheresis transfuse over min or 30 min per unit Irradiated; specify justification 3 Most recent platelet count /cc Date Indication: Platelet dysfunction due to (specify) 3 Platelet count ≤ 10,000/ cc prophylactically in a patient with failure of platelet production 3 Platelet count ≤ 20,000/ cc and signs of hemorrhagic diathesis (petechiae, mucosal bleeding) 3 Platelet count ≤ 50,000/ cc in a patient with (indicate): Active hemorrhage Invasive procedure (recent, in-progress, planned) 3 Platelet count ≤ 100,000/ cc in a patient with (indicate): cardiac surgery post-pump with evidence of platelet dysfunction surgery of, or potential for bleed, brain/eye/orbit Other (please specify): ______A single dose of platelets (adult: one pheresis) will increase platelet count by 25,000 - 35,000/ cc3 .

Plasma, to transfuse over min or 30 min per unit Most recent INR ______Date: ______Indication: Acute reversal of Warfarin Thrombotic Thrombocytopenia Purpura/Hemolytic Uremic Syndrome INR ≥ 2, with anticipated invasive/surgical procedure and/or potential for/presence of significant hemorrhage If INR < 2, please specify justification: ______Two units of FFP or thawed plasma (dose of 10 - 15 mL/ kg) is usually adequate to correct a coagulopathy

Pre-pooled cryoprecipitate (Cryo5), to transfuse at over min or 30 min per unit Indication: Fibrinogen ≤ 100 mg/dL Fibrinogen ≤ 150 mg/dL w/ active hemorrhage Dysfibrinogenemia One bag per 50 kg is usually adequate when cryoprecipitate is required Special product requests (specify justification):______

______/______Date Time Physician's signature & ID# Printed name Contact # Blood band #______(When applicable)

Transfusion Service # Walnut Creek 35371, Concord 22177 Patient Identification

ADULT TRANSFUSION ORDERS (NON-EMERGENCY RELEASE) Form # 80150 Rev 06/11 s:\ncrforms\80150transfusionorder V7.docx

Patient Safety in the OR The OR Management Series 15 • an executive director with links to senior ad- The blood bank must be engaged in this pro- ministration cess, advises Brocato. “They have to be willing to • a transfusion safety officer with links to nurs- take the heat when they refuse to fill an order for ing and ancillary staff 2 units.” As of July 1, 2011, the blood bank no longer • a medical director (physician champion) with completes any blood orders that are not on the links to medical staff. order form. Previously, it filled handwritten or- At John Muir, Brocato is the program’s execu- ders and sent a reminder to use the form, but that tive director. The safety officer is an RN who per- is no longer done. forms monthly audits of criteria for transfusion Some of the steps take time, Brocato notes. The and nursing documentation, works closely with physicians were given a year and a half to become nursing, blood bank staff, and the medical direc- used to the order form. Because of that, she has tor and reports to the executive director. not heard complaints since the July 1 transition. The medical director is a respected trauma sur- Blood management is a win-win, says Brocato. geon who is recognized as a conservative blood “It is the poster child for saving money and im- product user. He is willing to accept controversy proving outcomes and patient safety.” ❖ and engage the medical staff in a paradigm shift, —Judith M. Mathias, MA, RN Brocato says.

Success factors References She advises that a successful transfusion committee must be multidisciplinary, multispecialty, Bennett-Guerrero E, Zhao Y, O’Brien S M, et and action-oriented. Steps she recommends: al. Variation in use of blood transfusion in coronary artery bypass graft surgery. JAMA. • Gather baseline data on how much blood the 2010;304:1568-1575. hospital is using. The blood bank will have total volumes by product type. Bernard A C, Davenport D L, Chang P K, et al. In- traoperative transfusion of 1 U to 2 U packed red • Find out what the organization’s hemoglobin blood cells is associated with increased 30-day triggers are for transfusion compared to the ev- mortality, surgical-site infection, pneumonia, idence. Then look at the quality department’s and sepsis in general surgery patients. J Am Coll compliance data for how often the triggers are Surg. 2009;208:931-937. met. A trigger may be 10 g/dL, but physicians Carson J L, Terrin M L, Noveck H, et al. Liberal or may transfuse at 12 g/dL. restrictive transfusion in high-risk patients after • Establish new triggers using data from the hip surgery. N Engl J Med. Published online first, literature and physician input. Dec 14, 2011. www.nejm.org • Develop a transfusion order form with the new Hajjar L A, Vincent J L, Galas F R, et al. Transfu- triggers and educate the users (chart). sion requirements after cardiac surgery: The TRACS randomized controlled trial. JAMA. Communicating the message 2010;304:1559-1567. John Muir’s transfusion committee had the Health and Human Services Advisory Committee transfusion order form approved by the medical on Blood Safety and Availability (ACBSA). Meet- executive committee, and the medical director ing, June 7-8, 2011, Bethesda, Maryland. www. presented the form at all medical staff department hhs.gov/ash/bloodsafety/advisorycommittee/ meetings. The committee also wrote newsletter recommendations/recommendations_201106.pdf articles about the form, presented in-service pro- Hebert P C, Wells G, Blajchman M A, et al. A mul- grams, and sent a letter with the order form to all ticenter, randomized, controlled clinical trial of the physician offices. transfusion requirement in critical care (TRICC). Use of the transfusion order form is mandatory N Engl J Med. 1999;340:409-417. for John Muir physicians. They can order only 1 unit of blood at a time. Joint Commission Blood Management Performance Measures, 2011. http://www.jointcommission. Physicians must recheck the patient’s hemato- org/patient_blood_management_performance_ crit and hemoglobin after the first unit and before measures_project/ a second unit can be ordered. If the physician orders 2 units, only 1 is delivered. Napolitano L M, Kurek S, Luchette F A, et al. Clini- The form is used for all elective transfusions. cal practice guideline: Red blood cell transfusion Anesthesiologists are not required to use the in adult trauma and critical care. Crit Care Med. 2009;37:3124-3157. order form during surgery if blood is needed. Use of the form is not required in emergencies, such as This article originally appeared in OR Manager, the care of trauma patients. January 2012;28:1, 8-12.

16 The OR Management Series Patient Safety in the OR Capnography: New standard of care for sedation?

apnography—is it the standard of care for patients having moderate sedation? Should Standards for Basic Ccapnographic monitoring be added for procedures performed under moderate sedation Anesthetic Monitoring in areas like the preop holding area, GI endoscopy Effective July 1, 2011, these standards unit, and cath lab? The issue is generating discussion following from the American Society of Anesthesi- an update in the American Society of Anesthe- ologists apply to all general anesthetics, siologists (ASA) Standards for Basic Anesthetic regional anesthetics, and monitored an- Monitoring, which took effect July 1, 2011. The esthesia care. standards call for continuous monitoring of exhaled CO2 (ie, capnography) for moderate seda- Standard II tion (sidebar). During all anesthetics, the patient’s oxy- The update is a change from the 2005 stan- genation, ventilation, circulation, and tem- dard, which said that during regional anesthe- perature shall be continually evaluated. sia and monitored anesthesia care, the adequacy of ventilation shall be evaluated by continual observation of clinical signs and/or monitoring Ventilation 3.1 Objective: for exhaled carbon dioxide. To ensure adequate ventilation of the pa- The changes stand to have far-reaching effects. tient during all anesthetics. Managers in endoscopy units, cath labs, radiology departments, emergency departments, and 3.2 Methods: other treatment areas outside the OR are consider- 3.2.4 During moderate or deep sedation, ing how to incorporate the changes into policies the adequacy of ventilation shall be evalu- and procedures, staff training, nursing documen- ated by continual observation of qualita- tation, and budgeting for equipment and supplies. tive clinical signs and monitoring for the Quality, safety the goals presence of exhaled carbon dioxide unless “Our ultimate goal in updating the stan- precluded or invalidated by the nature of dards was to ensure quality patient care and pa- the patient, procedure, or equipment. tient safety,” Donald E. Martin, MD, a member www.asahq.org/For-Healthcare-Profes- of the ASA committee that wrote the update, sionals/~/media/For%20Members/documents/ told OR Manager. Standards%20Guidelines%20Stmts/Basic%20 “Historically, the use of pulse oximetry made Anesthetic%20Monitoring%202011.ashx a tremendous difference in patient safety, and the use of capnography in intubated patients made a tremendous difference. Now that level New technology, including better, less expen- of safety is being extended to a large number sive equipment, has made increased monitoring of patients who are having more invasive pro- more practical. cedures done with monitored anesthesia care,” says Dr Martin, professor of anesthesiology, Technology, costs Penn State University College of Medicine, Her- Capnography monitors use infrared spectros- shey, Pennsylvania. copy (a beam of infra-red light passed across the Also, ASA closed claims analyses are finding gas sample onto a sensor) to measure the expired that respiratory depression has become more com- concentration of CO2, a measure of effective ven- mon as more procedures that were once performed tilation. The end-tidal CO2 level and respiratory under general anesthesia in the OR began to be rate are displayed on the monitor numerically performed in other locations on older and sicker as well as graphically by a time-based waveform patients under deep and moderate sedation. called a capnogram. “The trend has been to increase monitoring, For a patient under moderate sedation, an and it’s surely paid dividends,” he says. accessory hose attached to the oxygen can-

Patient Safety in the OR The OR Management Series 17 Studies: Capnography use in cases monitored by capnography than in cases not monitored by capnography. during moderate sedation Waugh J B, Epps C A, Khodneva Y A. J Clin Anesth. 2011;23:189-196. Study in children In a study analyzing 163 children having Early warning sign GI endoscopy procedures with moderate In 247 patients having elective endoscopic sedation, capnography improved the stan- retrograde cholangiopancreatography dard of care by allowing early detection of and endoscopic ultrasonography under respiratory compromise. moderate sedation, researchers found Lightdale J R, Goldmann D A, Feldman H capnographic monitoring acts as an early A, et al. Pediatrics. 2006;117:e1170-1178. warning system, reducing the frequency of hypoxemia, severe hypoxemia, and apnea. Meta-analyses Qadeer M A, Vargo J J, Dumot J A, et al. A meta-analysis concluded that during pro- Gastroenterology. 2009;136:1568-1576. cedural analgesia and anesthesia, respiratory depression was 28 times more likely to Randomized trial be detected when patients were monitored In a randomized controlled trial of 132 by capnography rather than by traditional patients receiving propofol sedation in the methods (pulse oximetry, visual inspection). emergency department, adding capnogra- Waugh J, Khodneva Y, Epps C. Anesth phy to standard monitoring (pulse oxim- Analg. 2008;106(4 Suppl):S27. etry, cardiac function, and blood pressure) resulted in a decrease in hypoxia and iden- A meta-analysis of clinical studies con- tified all hypoxic events before onset. cluded that during procedural sedation and analgesia, cases of respiratory depression Deitch K, Miner J, Chudnofsky C R, et al. were 17.6 times more likely to be detected Emerg Med. 2010;55:258-264.

nula captures the expired CO2. During general Heard says this experience prompted her to anesthesia, expired CO2 is captured in tubing initiate its use in North Shore’s 7 endoscopy rooms. attached near the end of the endotracheal tube When the new ASA standard was issued, or mask. Heard enlisted the chief of anesthesia, who was Monitors are available for $3,000 to $5,000. already a proponent, as a champion. Another Depending on the type of monitor, single-use champion, the chief of medicine, is helping to CO2-measuring oxygen cannulas cost from $2.50 expand capnography to areas that use patient- to $12, compared to about 40 cents for a regular controlled analgesia (PCA) as well as to the nasal cannula. emergency department and gastroenterology. “Our main challenges are financial,” says Evidence for capnography Heard, referring to the cost of implementing Studies support use of capnography compared the standard. She also notes that a bad patient with pulse oximetry for earlier and more reli- outcome that capnography could have been pre- able warning of respiratory depression, says Lisa vented would also be expensive. Heard, BSN, RN, CPN, CGRN, nurse manager for endoscopy services at North Shore Medical Cen- Not a ‘magic pill’ ter, Salem, Massachusetts, and a past president of “Capnography is not a magic pill,” says Heard. the Society of Gastroenterology Nurses and As- “You can’t say that because you use capnography, sociates (SGNA) (sidebar). you are going to save lives. What it does is to tell Key papers showing the effectiveness of cap- you when a patient’s ventilation changes before nography in moderate sedation are by Jennifer any other monitoring device.” Lightdale, MD, and colleagues at Children’s For example, if a patient’s oxygen saturation Hospital Boston and John Vargo, MD, and as- drops to 95, 92, and 88, a pulse oximeter alerts the sociates at the Cleveland Clinic. Before taking nurse to intervene by repositioning the airway. In her current position, Heard spent 17 years at contrast, the capnometer alerts the nurse of a prob- Children’s Hospital, where she was involved in lem with the patient’s ventilation before the oxygen Dr Lightdale’s studies. saturation starts dropping, allowing the nurse to “The results convinced us to use capnography intervene and prevent a drop in oxygen saturation. on all of our pediatric patients receiving sedation,” says Heard. “We found we could decrease Capnography adds information. poor outcomes because we were alerted by the “We’re not saying, don’t use pulse oximetry and capnogram to intervene quicker when patients just use capnography. We’re saying that used to- had disordered breathing.” gether they result in safer patient care,” Heard says.

18 The OR Management Series Patient Safety in the OR VA weighs capnography Wright says she and her colleagues struggled The Department of Veterans Affairs (VA) is with how to implement capnography in the pre- considering the new ASA standard as it revises operative holding area, where regional anesthetic its moderate sedation directive, “but we are not blocks are performed and lines inserted, because sure which way they will go,” says Cindy Tay- they also administer medications for anxiolysis. lor, MSA, BSN, RN, CGRN, nurse manager for To make it easier for the preop nurses, the deci- GI endoscopy/bronchoscopy at Hunter Holmes sion was made that any patient having any pro- McGuire VA Medical Center, Richmond, Vir- cedure in the preoperative holding area would be ginia. The VA system presently does not require monitored. capnography for moderate sedation, and Taylor The biggest pushback was from surgeons and questions whether the VA will update the direc- proceduralists, who believed it was the anesthesia tive because of the lack of outcomes data and the provider’s responsibility to assess a patient’s air- cost of new equipment. way, not theirs. Wright says they learned it was “Outcomes data is the first thing the VA may their responsibility when no anesthesiologist was look at,” says Taylor, “and right now outcomes present, and this was the new standard of care. data is not there to substantiate the cost of the Capnography is invaluable in areas that don’t capnography.” have anesthesia coverage, Wright says. “We see But Dr Martin notes that a randomized con- capnography as imperative for patient safety. It trolled trial is unlikely to be conducted. He says alerts us to reduced ventilation before we have a the type of injury from hypoventilation and larger problem on our hands.” oversedation described in the ASA closed claims CMS requirement coming? data is rare, making it hard for researchers to Jennifer Haines, BSN, business manager for conduct a study with enough patients to show a surgical services at Chester County Hospital and difference in outcomes. Health System in West Chester, Pennsylvania, “If facilities are looking for an outcomes study calls the new ASA standard a “good idea that with hundreds of thousands of patients that adds an additional level of safety for patients.” separates out the benefits from capnography in She is in the process of acquiring new monitors addition to pulse oximetry in moderate sedation for the endoscopy unit and cath lab. patients, it is true they won’t find one,” he says. “This is a big deal for all of us. We are going to He adds that anesthesiologists would hesitate to have to do a lot of education and buy a lot of new participate in a randomized trial comparing patients expensive equipment. We are figuring out what with monitoring to those without monitoring be- we need to be ready because we expect CMS to cause of the potential risk to unmonitored patients, require capnography for moderate sedation in the making it unlikely such a study will be done. next year or so,” she says, referring to the Centers GI endoscopy guideline for Medicare and Medicaid Services. The American Society for Gastrointestinal En- John R. Rosing, MHA, FACHE, who consults doscopy (ASGE) in its 2008 guideline on Sedation with hospitals on Joint Commission and CMS and Anesthesia in GI Endoscopy states: “Extended matters, says the Joint Commission told him in monitoring techniques may provide sensitive mea- September 2011 that it is studying the capnogra- sures of a patient’s ventilatory function (capnog- phy issue. raphy) and level of sedation (BIS index monitor- “I can’t predict what CMS or the Joint Commis- ing); however, there is insufficient evidence in the sion is going to do about the ASA standard,” he literature to support the routine use of extended says. “The best we can say right now is that we don’t monitoring devices during moderate sedation.” know what CMS is thinking because its interpretive Taylor says practitioners may interpret this guidelines regard moderate sedation as analgesia, to mean that monitoring ventilation with a pulse not anesthesia. The Joint Commission, on the other oximeter and signs and symptoms is sufficient. hand, regards moderate sedation to be along the continuum of anesthesia and thus may be leaning Ahead of the curve to require [capnography].” Rosing is vice president Phoebe Putney Memorial Hospital in Alba- and principal, Patton Healthcare Consulting. ny, Georgia, began implementing capnographic Haines says she believes many institutions will monitoring for moderate/deep sedation and for wait for CMS to adopt a standard before getting patients with postoperative PCA pumps over a on board. She says many are interpreting a phrase year ago. Many new monitors were purchased. in the ASA standard that says, “unless precluded “The ASA standard will begin pushing other or invalidated by the nature of the patient, proce- institutions to add capnography for moder- dure, or equipment,” to mean, “If you don’t have ate sedation patients and others,” says Carol the equipment, you don’t have to do it.” In other Wright, BSN, RN, CNOR, director of the OR, words, they see the standard as a recommenda- SCP, anesthesia, and perfusion. “We were tion and not a requirement. ahead of the curve.” Educating clinicians Capnographic monitoring is now standard for every patient at Phoebe Putney who receives When capnography use is expanded, clinicians procedural sedation no matter where that occurs. have to be trained to interpret the capnogram Patient Safety in the OR The OR Management Series 19 wave forms and the kinds of waves that indicate Appendix A. Memorandum to State Survey apnea or hypoxia. Agency Directors. Jan 14, 2011. ttp://www.soap. Nurses must document the patient’s capno- org/CMS-revised-guideline-synopsis-1-11.pdf graphic readings on the procedural record. In Gerstenberger P D. Capnographic monitoring for en- addition to writing a single number from the doscopic sedation: Coming soon to an endoscopy capnometer, Heard recommends adding an end- unit near you? ASGE News. 2011;18:1, 24-26. tidal CO column on the patient flow sheet to 2 Lichtenstein D R, Jagannath S, Baron T H, et al. Se- allow the nurse to indicate a normal waveform. dation and Anesthesia in GI Endoscopy. Gastro- If there is an abnormality in the capnogram, the intestinal Endoscopy. 2008;68:815-826. nurse should describe it in the patient note with the intervention performed (eg, repositioned air- Lightdale J R, Goldmann D A, Feldman H A, et way, suctioned oropharynx) and the result. al. Microstream capnography improves pa- “That is the best way to show not only that tient monitoring during moderate sedation: a randomized, controlled trial. Pediatrics. the nurse was monitoring the capnogram but 2006;117:e1170-1178. that when a change was recognized, it was documented,” she says. ❖ Metzner J, Posner K L, Domino K B. The risk and —Judith M. Mathias, MA, RN safety of anesthesia at remote locations: The US closed claims analysis. Curr Opin Anaesthesiol. 2009;22:502-508. References Metzner J, Posner K L, Lam M S, et al. Closed American Society of Anesthesiologists. Standards claims’ analysis. Best Pract Res Clin Anaesthe- for Basic Anesthetic Monitoring. http://www. siol. 2011;25:263-276. asahq.org/For-Healthcare-Professionals/~/ media/For%20Members/documents/Stan- Qadeer M A, Vargo J J, Dumot J A, et al. Cap- dards%20Guidelines%20Stmts/Basic%20Anes- nographic monitoring of respiratory activity thetic%20Monitoring%202011.ashx improves safety of sedation for endoscopic cholangiopancreatography and ultrasonography. Bhananker S M, Posner K L, Cheney F W, et al. Gastroenterology. 2009;136:1568-1576. Injury and liability associated with monitored Vargo J J, Cohen L B, Rex D K, et al. Position state- anesthesia care: A closed claims analysis. Anes- ment: Nonanesthesiologist administration of thesiology. 2006;104:228-234. propofol for GI endoscopy. Gastroenterology. 2009;137:2161-2167. Centers for Medicare and Medicaid Services. Re- vised Hospital Anesthesia Services Interpretive This article originally appeared in OR Manager, Guidelines—State Operations Manual (SOM) March 2012;28:17-20.

20 The OR Management Series Patient Safety in the OR Early action advisable to prepare for new alarm safety standards

alk into any patient care unit—whether • potential for harm based on incident history preoperative, intraoperative, or post- • review of best practices and guidelines. Woperative—and you will hear numerous alarm signals. Some are signaling a medical Form a multidisciplinary committee necessity, but many are false alarm noises that do Before July 1, hospitals will want to form a not require action. multidisciplinary committee to review the lit- Health care workers can hear several hundred erature and decide which alarm signals or alarm alarm signals per patient per day, which may systems are most important to manage, says John cause alarm fatigue. Overwhelmed or desensi- R. Rosing, MHA, FACHE, vice president and tized by the constant barrage, care givers may principal, Patton Healthcare Consulting, Milwau- take unsafe actions, such as turning down the kee, Wisconsin. devices, shutting them off, or ignoring them. It is important that hospitals do this early, so Patient safety advocates have warned of alarm the prioritization of alarms is established before fatigue for years, and it’s a growing concern as July 1, says Rosing. The committee should keep hospitals invest in more complex devices with a detailed minutes of its meetings, including a di- growing number of features and sensors. rective from leadership stating that alarm safety In June, the Joint Commission approved a new is an organizational priority. This documentation National Patient Safety Goal on clinical alarm safety will be needed to demonstrate compliance when (NPSG.06.01.01). The effective date is January 2014. the Joint Commission does its survey, he says. The goal consists of 4 elements of performance “I believe the committee should be organiza- to be phased in over 2 years—2 start in 2014 tional and not departmental,” advises Mary Logan, (Phase I), and 2 start in 2015 (Phase II). JD, CAE, president of the Association for the Ad- The Joint Commission says it plans to publish vancement of Medical Instrumentation (AAMI). the Phase I and II requirements at the same time “If you try to approach the alarm problem as an to provide the field with complete information OR issue, a PACU [postanesthesia care unit] issue, about the ultimate requirements of NPSG.06.01.01. an ICU [intensive care unit] issue, or something Phase II requirements may be enhanced before else, the problem isn’t going to be solved,” says they are implemented in 2015. These changes Logan. The committee needs to involve nursing could arise from hospitals’ experience with Phase leadership, quality and patient safety leadership, I requirements as well as newly emerging evi- physician leadership, clinical engineering, and in- dence about best practices. If any changes to the formation technology, she says. Phase II requirements are made, accredited hospi- “A senior administrator, such as a chief nurs- tals will be notified. ing officer or a chief medical officer, has to lead The new goal will appear in the 2013 Update this effort,” says Robert Maliff, MBA, director, 2 to the Comprehensive Accreditation Manual applied solutions group, at ECRI Institute. “You for hospital and critical access hospital programs. need someone who is really going to believe in this and push this and secure the resources, or Phase I begins in 2014 things will fall through the cracks,” he says. Every member of this multidisciplinary team The first 2 elements of performance (EP) re- has a distinct role, says Maliff. For example, physi- quire the following: cians are vital because they are ultimately respon- EP 1. As of July 1, 2014, hospital leaders es- sible for patient care, and they can help establish tablish alarm safety as an organizational priority. alarm parameters. Nurses are crucial because they EP 2. During 2014, hospitals identify the most are ultimately responsible for responding to all important alarms to manage based on the following: alarms. Clinical engineering staff are important • input from medical staff and clinical departments because they will be responsible for changing the • risk to patients if the alarm is not answered or alarm defaults. Both AAMI and ECRI Institute are malfunctions engaged in activities to promote safe alarm system • whether alarms are needed or unnecessarily management and support the National Patient contribute to alarm noise and fatigue Safety Goal (see box).

Patient Safety in the OR The OR Management Series 21 Resources for alarm management Association for the Advancement • Health Devices Achievement Award win- of Medical Instrumentation (AAMI) ners, which includes the Johns Hopkins The AAMI website contains useful infor- Hospital Comprehensive Alarm Manage- mation on safely managing alarm systems ment Initiative with links to activities the AAMI Healthcare • Pennsylvania Patient Safety Authority Technology Safety Institute is engaged in alarms resources. (https://www.ecri.org/ to promote safe alarm system management, Forms/Pages/Alarm_Safety_Resource.aspx) including: • survey of hospital practices in setting Joint Commission alarm parameters, followed by a study of The Joint Commission published a Sentinel alarm parameters Event Alert on medical device alarm safety • library of literature on best practices on in April 2013. The alert contains suggestions alarm system management for assessing and managing risks associated • webinars on safe alarm management with alarms and complements the expecta- • summary of the Clinical Alarms Summit tions of the new safety goal. hosted by AAMI in 2011. http://www.aami.org/htsi/alarms/ (http://www.jointcommission.org/sea_ issue_50/) ECRI Institute ECRI Institute offers information such as Other Joint Commission resources include: articles, policies, and webinars on safely • 2 Take 5 podcasts (http://www. managing alarm systems on its website. The jointcommission.org/podcast. website also includes: aspx?CategoryId=13&F_All=y) • Health Devices Top 10 Health Technology • replay of an alarm safety webinar held in Hazards, which lists alarm hazards as the May. (http://www.jointcommission.org/ number 1 issue for 2012 and 2013 alarm_safety_webinar/)

Tailor strategies Rosing anticipates that surveyors will go into According to the Joint Commission, it is im- the OR and ask, “Have you been part of the portant for each hospital and each department discussion on alarm management and fatigue?” to understand its own situation and to devel- OR managers will want to be able to say “yes we op a systematic, coordinated approach to alarm have,” says Rosing, and they may want to con- management. Standardization contributes to safe tinue with “we have decided to leave our alarm alarm management, but solutions may have to be settings as they are.” That would reflect a deliber- customized for specific clinical units and patients. ate decision made by OR leaders as opposed to Each care unit has a unique set of circum- not having been at the table at all, he says. stances dictating how alarm signals are heard and Prioritize alarms responded to, says Rikin Shah, senior associate, The approved version of the safety goal is easi- applied solutions group, ECRI Institute. Thus, er to comply with than the draft would have been, alarm response strategies should be tailored to says Rosing. The annual inventory of alarms has each unit. been deleted, and the phasing of the safety goal The architectural layout and the alarm cover- into 2014 and 2015 rather than January 1, 2014, age model play a huge role, says Shah. For ex- allows more time for implementation. ample, most PACUs are open spaces with direct Even though the annual inventory has been lines of communication between nurses and pa- deleted, he says, it will likely be necessary to cre- tients, so most alarm signals are both heard and ate a master inventory list of all alarms or alarm seen across the unit. In ICUs, where patients are systems so the committee will have something to secluded in small private settings, a more robust work from as it prioritizes the alarms that are the plan for communication and alarm response is most important. needed. It also may be useful to categorize this list by Alarm fatigue is not quite the same issue in the service, such as alarms serving the OR, PACU, OR that it is in the ICU, says Rosing. In the OR, it is ICU, medical-surgical units, telemetry units, and understood what alarm signals mean for a patient, the emergency department. and they are responded to quickly. But, Rosing “When identifying the highest priority alarms,” says, OR leadership will still want to participate in notes Logan, “you have to ask, ‘What are the ac- committee discussions and decisions about alarms.

22 The OR Management Series Patient Safety in the OR Top 10 Actions You Can • Test acoustics on clinical floors: Environ- mental noise impacts patient and staff Take Now: 10 things you well-being and patient safety. can do now to improve • Implement an alarm system configuration policy based on clinical evidence. alarm conditions in your • Change single-use sensors more fre- health care organization quently to reduce nuisance alarm conditions (except in pediatric units). • Gain cross-disciplinary leadership support. • Mandate alarm system management train- • Establish a cross-functional team with ing for all clinical operators. clinical leadership to address alarm fa- • Share experiences with AAMI, the FDA, tigue across all environments of care. TJC, ECRI Institute, and others with • Re-establish priorities: Process should problem reporting systems so everyone drive technology adoption rather than al- can benefit from your efforts in a cross- lowing technology to drive the process. disciplinary way. • Develop a continuous improvement process for constantly optimizing alarm system policies and configurations. This list was originally published in Clinical • Conduct clinical testing and analyze Alarms: 2011 Summit, a report from the As- alarm data to implement optimized alarm sociation for the Advancement of Medical In- limits and delays (both alarm condition strumentation, www.aami.org. Reprinted with and alarm signal generation delays) and permission. Any other distribution of AAMI- to reduce clinically nonactionable alarm copyrighted material requires written permis- conditions. sion from AAMI. tionable alarm signals and why? What are the non- • when alarm parameters can be changed actionable alarm signals and why? How can you • who in the organization has the authority to set assess who needs to hear them and why?’” alarm parameters, change alarm parameters, For example, says Logan, nurses and anesthe- and set alarm parameters to “off” siologists have very specific requirements for the • monitoring and responding to alarm signals alarm signals needed in the OR, which are different from the alarm signals nurses need in the • checking individual alarm signals for accurate PACU, surgical ICU, or cardiac ICU. “This is why settings, proper operation, and detectability. everyone has to work together,” she says. EP 4. Hospitals will educate staff and licensed In 2011, AAMI and the Food and Drug Admin- independent practitioners about the purpose and istration co-convened a Clinical Alarms Summit. proper operation of alarm systems for which they It brought together clinicians, regulators, alarm are responsible. system experts, industry, and others to discuss and set priorities for alarm management issues. Manage alarms The Joint Commission, ECRI Institute, and Ameri- Two of the key issues to be addressed by poli- can College of Clinical Engineering also partici- cies and procedures for alarm management are pated in the summit, which brought much greater clinically appropriate settings for alarm signals national attention to the problems with alarm and unnecessary alarm signals. management and identified priorities for action. “To have clinically actionable alarm signals, A list of “Top 10 Actions You Can Take Now” which means eliminating nuisance alarm noise, to improve alarm conditions in health care organi- you first need to look at what is happening in the zations was developed from audience discussion context of your unit,” says Shah. at the summit (see box). For example, how are system alarm sounds such as leads-off alarm signals being handled? Phase II begins in 2015 Too many leads-off alarm signals could be a In the last 2 elements of performance, the fol- result of inadequate skin preps and lack of lowing steps are required as of January 1, 2016: electrode replacement. Most hospitals probably EP 3. Hospitals will establish policies and already have a skin prep policy for leads and procedures for managing the alarms identified electrode replacement, and they could eliminate in EP 2. many of these system nuisance alarm sounds if At a minimum, these policies and procedures they were following their policies, Shah says. He will address: noted that ECRI Institute was part of an alarms • clinically appropriate settings for alarm signals management review at Johns Hopkins Hospital in Baltimore in which proper skin preps and • when alarm signals can be disabled

Patient Safety in the OR The OR Management Series 23 electrode replacement eliminated close to half of trouble,” she says. “This is something that takes the alarms on an acute care unit. AAMI’s “Top 10 planning and takes time.” ❖ Actions” list also includes changing leads. —Judith M. Mathias, MA, RN Another policy that might already be in place is standardization of default volume set- References tings on monitoring equipment or in central Cvach M. Monitor alarm fatigue: An integrative stations, says Shah. review. AAMI Biomedical Instrumentation & “One of the things we recommend is attacking Technology. July/August 2012;46:268-277. the ‘low-hanging fruit’ first,” says Maliff. “Start Joint Commission. The Joint Commission announc- with the care areas with a lot of alarms and a lot of es 2014 National Patient Safety Goal. Joint Com- monitored patients. It is a tall task to tackle every mission Perspectives. July 2013;33:1, 3-4. single unit with physiologic monitors,” he says. http://www.jointcommission.org/joint_commis- Health care delivery organizations need to set sion_announces_2014_npsg/ a timeline for what they are going to get done by when, says Logan. Hospitals that think they can wait until the 4th quarter of 2015 to imple- This article originally appeared in OR Manager, ment new alarm policies “are going to be in big September 2013;29:1, 17-19.

24 The OR Management Series Patient Safety in the OR Fast action, team coordination critical when surgical fires occur

ew information on surgical fires sheds Of 65 reports with information about the ignition light on risk factors, patterns of injury, source, an electrosurgical unit was the source in Nand why OR teams need to plan for their 58%, a fiberoptic light cord in 38%, and a laser in 3%. occurrence. The role of oxygen was highlighted in 7 re- A May 2013 study led by Karen B. Domino, MD, ports, with 2 specific mentions of nasal cannulas, MPH, is the first to assess closed malpractice cases 1 “leak” in the oxygen tubing, 1 oxygen mask of surgical fires. Dr Domino, professor of anesthe- over a tracheostomy stoma, and 1 using an elec- siology and pain medicine and adjunct professor of trosurgical instrument to incise a trachea during a neurological surgery at the University of Washing- tracheostomy. ton, Seattle, and colleagues analyzed 103 OR fire The data shows a slight downward trend in claims in the American Society of Anesthesiologists the number of fires—ranging from 1 per 157,545 (ASA) Closed Claims Database from 1985 to 2009. procedures from 2007 to 2008 to 1 per 309,305 Most claims involved patients who had moni- procedures from 2010 to 2011—but there is still a tored anesthesia care (MAC) with open oxygen need for vigilance, says Mark Bruley, CCE, vice delivery for upper chest, neck, and head proce- president, accident and forensic investigation at dures. Electrosurgical instruments were respon- ECRI Institute, coauthor of the report. sible for fires in 90% of claims. Recognition of the fire triad (oxidizer, fuel, Role of MAC, oxygen and ignition source), particularly the role of In her study, Dr Domino found that malprac- supplemental oxygen by an open delivery system tice claims related to electrosurgical-ignited fires during use of electrosurgical instruments, is key during MAC increased from 6% of such claims to prevent OR fires, says Dr Domino. Prevention between 1985 and 1989 to almost one-third of is important because fires occur so quickly in the claims related to MAC between 2000 and 2009. presence of oxygen, she says. “We are seeing more fires in MAC cases in A December 2012 report from the Pennsylva- recent years because we are doing more MAC nia Patient Safety Authority analyzed 70 reports cases,” she explained. MAC has become a lot of OR fires submitted to its database from July 1, more popular, especially in the ambulatory set- 2004, to June 30, 2011. ting, because patients have less nausea and vom- The fires occurred on the surgical field or in the iting and are less sedated; thus, they can be dis- patient’s airway. charged more quickly.

About best practices “Joint Recommendation for Healthcare Industry Representative Credentialing Best Prac- tices” outlines best practices for 3 levels of representatives. • Level I reps don’t have access to patient care areas. • Level II reps have access to patient care areas but not to sterile or restricted areas. • Level III reps have access to patient care, sterile, and restricted areas such as the OR. Requirements are tailored to the level of access. Elements of the best practices document include credentialing requirements (eg, proof of liability insurance, immunization, proof of criminal background check, training requirements), what should not be required (eg, electrical safety training), and enforcement. Training requirements specific to the OR (sterile and aseptic techniques), which are required only for Level III reps, should be based on guidelines from AORN and the Ameri- can College of Surgeons. Source: Joint Recommendation for Healthcare Industry Representative Credentialing Best Practices. Available for download at http://www.hcirbestpractice.org.

Patient Safety in the OR The OR Management Series 25 Managing vendor access In addition to computer systems, here are eration. “Once we gained the surgeons’ other actions you can take to regulate ven- support, they helped to convert the most dor access: difficult vendors.” • Require vendors to wear a different color • Get staff on board. Educating staff about of scrubs. the requirements and emphasizing the • Lock up scrubs and make vendors show need for patient safety helps improve their badge to obtain them. staff buy in, Norberg says. “Those in the • Give vendors a special colored badge to OR department need to be the eyes and wear that is timed and dated. ears for credentialing compliance suc- • Require vendors to call and schedule cess,” she adds. an appointment. “Reps who drop in are “Vendor credentialing has to be a cultural interrupting patient care,” says Coleen approach, just like safety and infection con- Norberg, purchasing manager for Ellis trol,” says Bruce Mairose, MHA, BBA, vice Medicine. According to a survey by chair of operations for supply chain man- L.E.K., 75% of hospitals require vendors agement at the Mayo Clinic. “Employees in to make an appointment. the organization need to be watching, and if • Get surgeons on board. Norberg says there is a problem, they need to let the sup- showing the requirements to the sur- ply chain management department know geons and explaining that it’s a patient so we can handle it in collaboration with the safety issue has helped improve coop- clinical department.”

A contributing factor is that many MAC pa- Coordinated approach tients are given propofol, which can result in The Pennsylvania Patient Safety Authority more respiratory depression more quickly, so an- says a coordinated approach to surgical fire pre- esthesia providers put oxygen on these patients— vention and response by the surgical team is im- whether they need it or not—just out of fear they portant to eliminate fire hazards and to minimize might desaturate, she says. the time needed to extinguish the fire. Anesthesia personnel also give more oxygen Three elements are necessary for a fire: a heat now than in the past, says Dr Domino, because of source, oxygen, and fuel: pulse oximetry. “They are more cognizant of the oxygen saturation, and they give more oxygen,” • The surgeon is usually in control of the heat she says. source (eg, electrosurgical unit) and can re- According to the ASA Task Force on Operat- move it from the field. ing Room Fires and the Anesthesia Patient Safety • Anesthesia personnel are usually in control of Foundation, the most important practice for man- the oxygen source and can turn it off. aging fire risk is to determine if supplemental oxy- • The circulating nurse and scrub technician can gen is needed during the procedure. This is espe- help ensure that alcohol-containing skin-prep cially important when oxygen is administered via a solutions are meticulously applied; the skin nasal cannula or face mask, which would saturate is dry before applying surgical towels and the surgical field with high oxygen concentrations. drapes; moist sponges, towels, and aqueous To reduce risk, keep oxygen concentrations at solutions are available; and exposed ends of less than 30% because there is less combustion at fiberoptic light cords are kept off the field. this level, says Dr Domino. The end of the fiberoptic light cord is as danger- Risk can be reduced further by using open ous as a lit cigar on the surgical field, with tempera- draping techniques to prevent accumulation of tures reaching 670° F, Bruley notes. oxygen under the drapes. If a fire occurs, the surgeon and other team When there is a risk of fire and the patient members can remove burning materials and extin- requires oxygen, anesthesia personnel should guish the fire with water or saline, their hands, or a consider a general anesthetic with an endotra- wet sponge or towel. Ideally, a wet sponge or towel cheal tube or laryngeal mask, rather than expose is always available for an emergency. the patient to a heightened risk, Dr Domino says. Anesthesia personnel should minimize the Other recommendations include not using availability of oxygen. Burning materials that have regular monopolar electrosurgical instruments, if been removed can then be extinguished by other possible, in high-risk situations. If used, the power team members, if needed, with water, saline, or— settings should be as low as possible, consistent in extreme cases—with a fire extinguisher. with clinical needs, says Bruley. Instead, consider Of the 70 OR fire reports the Pennsylvania Pa- using bipolar electrosurgical instruments, if they tient Safety Authority analyzed, 23 named ways will meet the needs of the procedure, he says. in which fires were extinguished.

26 The OR Management Series Patient Safety in the OR These included: A score of 3 indicates high risk; 2 indicates low • removing a surgical drape and dousing it with risk, with potential for conversion to high risk; 1 saline indicates low risk. • moving a surgical sponge to a basin of saline The score can be included in the World Health Organization’s Surgical Safety Checklist preoper- • removing, disconnecting, or turning off the ative briefing or the Universal Protocol time-out. light cord when it was the ignition source OR teams need to have a standardized plan • dousing the fire with saline or water and discussion, notes Dr Domino. “You can have • extinguishing the fire with towels (1 noted the fire risk on your checklist, but if the team doesn’t towels were wet) communicate that the surgeon will announce to the anesthesiologist when he is going to use the • putting out a bone cement fire with the hand electrocautery, the anesthesiologist won’t know • extinguishing a fire caused by the electrosurgi- and will leave the oxygen running,” she says. cal unit entering the trachea with use of the Continuing education and communication surgeon’s hand, dousing the site with saline, along with fire prevention protocols are key to and discontinuing supplemental oxygen. reducing OR fires. ❖ —Judith M. Mathias, MA, RN Risk assessment The Pennsylvania Patient Safety Authority recommends a simple fire risk assessment score, References such as the one Christiana Care Health System, Mehta S P, Bhananker S M, Posner K L, et al. Operat- Wilmington, Delaware, developed to identify ing room fires. Anesthesiology. 2013;118:1133-1139. procedures likely to pose an increased risk for Clarke J R, Bruley M E. Surgical fires: Trends as- surgical fires. A score showing the following 3 sociated with prevention efforts. Pennsylva- elements are present indicates high risk: nia Patient Safety Authority Safety Advisory. • surgery above the xiphoid 2012;9;130-134. • open oxygen source • available ignition source (eg, electrocau- This article originally appeared in OR Manager, tery, unit, laser, fiberoptic light cord). November 2013;29:9-10.

Patient Safety in the OR The OR Management Series 27 FDA issues Unique Device Identification final rule

he Food and Drug Administration (FDA) “The GUDID will be used as a foundation for on September 24 published the final rule improving the quality of device public health re- Tfor its Unique Device Identification (UDI) porting and medical device recalls,” he says. system to provide a consistent way to identify “The new UDI rule will—over time—impact medical devices throughout their distribution all medical devices used in the hospital,” says and use. James P. Keller, Jr, vice president, health technol- “A UDI system for medical devices is an im- ogy evaluation and safety, ECRI Institute. “Some portant step towards increasing patient safety, of the first to be affected are key parts of a surgery modernizing postmarket surveillance, and facili- department’s operations (ie, implants). It’s im- tating medical device innovation,” says Jay Crow- portant for OR managers to first become familiar ley, the FDA’s senior advisor for patient safety, with the gist of the rule and work with materials center for devices and radiological health. management and clinical engineering profession- Once implemented, the UDI system is ex- als to consider how medical devices with new pected to have many benefits for the healthcare UDI labeling will be recorded in their inventory system and the device industry, says Crowley, management and purchasing systems.” including: Phased-in implementation • improved visibility as devices move through the distribution chain up to the point of patient use Implementation of the UDI system will take place over 7 years, focusing first on high-risk devic- • enhanced ability to quickly and efficiently es and extending to most other devices. Some low- identify marketed devices during recalls and risk devices are completely exempt from the rule. other safety actions In general, the rule requires: • enhanced ability to accurately identify devices • 1 year after publication of the final rule—labels and adverse event reports and packages of Class III devices and devices • strengthened support for electronic health re- licensed under the Public Health Service Act cords through a standard way to document must bear a UDI. A 1-year extension may be device use. requested; submission must be no later than June 23, 2014. UDI core elements • 2 years—labels and packages of implantable, The UDI system has 2 core elements: life-supporting, and life-sustaining devices • A unique number assigned by the device must bear a UDI, and the UDI must be perma- manufacturer, called a unique device identi- nently marked on the device if it is intended fier, which includes information such as lot or to be used more than once and reprocessed batch number, serial number, expiration date, before each use. Data for these devices must be and manufacturing date. A distinct identifica- submitted to the GUDID database. tion code will be used for human cells, tissues, • 3 years—Class III devices with a UDI on or cellular- and tissue-based products regu- the label and package must be permanently lated as devices. marked if intended to be used more than once • A publicly searchable database administered and reprocessed before each use. Labels and by the FDA, called the Global Unique Device packages of Class II devices must bear a UDI, Identification Database (GUDID), that will and data for these devices must be submitted catalogue device information for every device to the GUDID database. required to bear a UDI. No identifying patient • 5 years—Class II devices requiring a UDI on information will be stored in this database. the label or package must be permanently Crowley says he expects the FDA, medical marked if intended to be used more than once device industry, healthcare systems, clinicians, and reprocessed before each use. Labels and patients, and others will use the GUDID to ob- packages of Class I devices and devices that tain important descriptive and use information have not been classified must bear a UDI, and to find similar devices in cases of recalls and these devices must be submitted to the or shortages. GUDID database.

28 The OR Management Series Patient Safety in the OR • 7 years—Class I and unclassified devices with References a UDI on the label and package must bear a http://www.fda.gov/Medical Devices/DeviceReg- permanent UDI marking if intended to be used ulation andGuidance/UniqueDevice Identifica- more than once and reprocessed before each use. tion/default.htm The UDI system, which builds on current device https://www.federalregister.gov/ industry standards and processes, reflects substan- articles/2013/09/24/2013- tial input from the clinical community and the medi- 23059/unique-device- cal device industry, says Crowley. By building on identification-system systems already in place, the FDA strives to reduce the burden on the medical device industry. ❖ This article originally appeared in OR Manager, —Judith M. Mathias, MA, RN November 2013;29:5, 26.

Patient Safety in the OR The OR Management Series 29 Joint Commission targets fatigue from clinicians’ extended hours

n a new alert, the Joint Commission adds its includes getting enough sleep and practicing voice to calls to curb fatigue from extended good sleep habits. Iwork days and work hours. The alert highlights • Provide opportunities for staff to express con- evidence linking fatigue to adverse events and cerns about fatigue, supporting their concerns outlines actions organizations can take to mitigate and taking action. fatigue, especially among nurses and physicians. • Encourage teamwork to support staff who The commission says the alert is purely edu- work extended hours to protect patients from cational, and there will be no change in the sur- harm, such as second checks for critical tasks vey process. or complex patients. Despite the evidence of risks posed by fatigue, health care has been slow to adopt changes, par- • Consider fatigue as a potential contributing ticularly for nursing, the commission says. factor when reviewing all adverse events. Numerous studies have linked nurse fatigue to • For organizations with a policy for sleep patient safety, the alert notes. The first, a ground- breaks, assess the environment provided for breaking 2004 study, showed nurses working sleep breaks. shifts of 12.5 hours or longer are 3 times more likely to make an error. Other studies have linked 12-hour shifts in the OR long shifts to the risk of errors, close calls, and Perioperative managers and directors gave decreased vigilance, as well as higher rates of extended shifts mixed reviews in a survey by OR nurse injuries. Manager (September 2010 issue). “An overwhelming number of studies keeps In all, two-thirds of participants used 12-hour saying the same thing−once you pass a certain shifts for nursing staff. Of those, the largest group point, the risk of mistakes increases significant- said 25% or less of their staff worked these longer ly,” according to Ann Rogers, PhD, RN, FAAN, hours. a sleep medicine expert at Emory University, The top 3 reasons for 12-hour shifts in the OR quoted in the alert. were: Residents’ duty hours have also been a focus • matching operating schedules of some sur- of studies, and standards have been set by the geons or specialties Accreditation Council for Graduate Medical Edu- • covering off-shifts cation. • aiding recruitment and retention. Steps to address fatigue Many said the extended shifts are popular The commission suggests 8 steps to help ad- with nurses, and doing away with them would be dress effects of fatigue from extended work hours. unpopular in a specialty where recruitment and Here is a summary: retention are an issue. • Assess your organization’s fatigue-related AORN has a guidance statement on safe call risks, including assessment of off-shift hours, practices plus a position statement suggesting consecutive shifts, and other staffing practices. that periop RNs not be required to work in direct patient care for more than 12 consecutive • Assess handoff processes because they are a hours in a 24-hour period and not more than high-risk time, especially for fatigued staff. 60 hours in a 7-day period, consistent with an • Invite staff input into scheduling to minimize Institute of Medicine report. Exceptions, such as potential for fatigue. disasters, should be outlined in organizational • Create and adopt a fatigue management plan policy. ❖ that includes scientific strategies to fight fatigue, such as actively conversing with others, The Sentinel Event Alert, issued December 14, engaging in physical activity, using caffeine 2011, is available at www.jointcommission.org. judiciously, and taking short naps. • Educate the staff about sleep hygiene and fa- This article originally appeared in OR Manager, tigue’s effects on patient safety. Sleep hygiene February 2012;28:1, 5.

30 The OR Management Series Patient Safety in the OR Malignant hyperthermia: A crisis response plan

alignant hyperthermia (MH) is a genetic have a myopathy (Wappler, 2010). Gender and geo- skeletal muscle disorder that is incited graphic factors have also been found to contribute to Mby anesthesia drugs including succin- increased mortality rates in persons already having lycholine and inhaled anesthetic agents (Gurun- an MH diagnosis (Rosero et al, 2009). luoglu et al, 2009; Hopkins, 2011; Kim et al, 2011). Preparation also involves having emergency The disorder is particularly dangerous because equipment and medications readily available as well it rapidly develops into a hypermetabolic state as developing an action plan to address an MH crisis. resulting in hyperpyrexia, tachycardia, and intense and unrelenting muscle contraction as well Crisis management as alterations in electrolyte and acid-base balance An MH crisis develops rapidly and taxes re- (Kim et al, 2011). sources quickly. Managing an MH crisis requires an Though the incidence is reported to have in- approach involving multiple personnel and multiple creased from 2000 to 2005 from 10.2 episodes per tasks promptly initiated and deliberately executed. 1 million hospital discharges to 13.3, the mortality Crisis resource management is a methodol- rate has steadily declined to approximately 11.7% ogy focusing on task delegation during stressful as greater understanding of the pathophysiol- situations such as an MH crisis. Deeply rooted ogy and treatment of the disorder has developed in the aviation industry, crisis resource manage- (Rosero et al, 2009). ment has become essential in health care because Clinician and patient preparation are key in it promotes development of team dynamics and developing a plan of care for any patient having cooperation (Rudy et al, 2007). Similarly, crew a general anesthetic. Personal and family histories resource management inspires a group of person- should be obtained to delineate which patients have nel to function cooperatively as a team with an a greater risk for an MH crisis, such as those who ultimate goal of safety (McConaughey, 2008).

MHAUS Treatment Recommendations for Malignant Hyperthermia CALL the MH 24-hour Hotline (for emergencies only)

United States: 1+800-644-9737

Outside the US: 00+1+303-389-1647

START Emergency Therapy for MH Acute Phase Treatment

1. Get help. Get Dantrolene. Notify surgeon.

2. Dantrolene Sodium for Injection 2.5 mg/kg rapidly IV through large-bore IV, if possible.

3. Bicarbonate for metabolic acidosis.

4. Cool the patient.

5. Dysrhythmias: Usually respond to treatment of acidosis and hyperkalemia.

6. Hyperkalemia.

7. Follow: ETCO2, electrolytes, blood gases, CK, serum myoglobin, core temperature, urine output and color, and coagulation studies.

Source: Malignant Hyperthermia Association of the United States. Emergency Therapy for Malignant Hyperthermia. Copyright 2011 MHAUS.org. All rights reserved. Reproduced with permission. Available at www.mhaus.org/healthcare-professionals

Patient Safety in the OR The OR Management Series 31 Malignant Hyperthermia Task Distribution Worksheet Each set of tasks is printed on a different-colored card. The cards are held together with a ring and can be easily separated for use. Circulator/OR staff ■ Overhead announcement of MH emergency & summon MH cart to room. ■ Call MHAUS (1-800-644-9737). Hand phone to anesthesia team. ■ Help reconstitute Dantrolene. ■ Insert Foley catheter and obtain urine specimen as needed. ■ Obtain supplies for cold lavage of open cavities. Anesthesia technician ■ Bring MH cart to room. ■ Bring i-STAT and appropriate lab containers to room. ■ Bring bags of ice to room. ■ Bring additional drugs to room. ■ Prime a bag of sterile water using warming device & label “DO NOT CONNECT TO PATIENT.” Surgeon ■ Stop operating ASAP. ■ Cold lavage of open cavities. Anesthesia team ■ Instruct circulator to call an overhead announcement of MH emergency and ask for MH cart. ■ Turn off all triggering anesthetics. ■ Hyperventilate at 10 L/minute with 100% O2 via bag valve mask. ■ Assign tasks and delegate as required. ■ Calculate Dantrolene dose (2.5 mg/kg. Note: each bottle contains 20 mg) & repeat as needed. ■ Cease warming devices. ■ Draw lab work (whole blood profile, CK, coagulation studies, electrolytes). ■ Place NG & initiate cold lavage. ■ Treat metabolic acidosis (1-2 mEq/kg sodium bicarbonate) if lab values unknown. ■ Treat urine output <0.5 mL/kg/hr with hydration & diuretics. ■ Monitor urine output (treat dark/cola-colored urine with bicarbonate, hydration, & diuretics). ■ Continue to follow MHAUS treatment protocol. Additional anesthesia/ancillary staff. ■ 3 to 4 people mix 2.5 mg/kg of Dantrolene (utilize 60 mL sterile water per 20 mg bottle). ■ Insert A-line & large-bore IVs/central line as needed. ■ Maintain charting of events & interventions. MHAUS = Malignant Hyperthermia Association of the United States. www.mhaus.org Source: Geisinger Medical Center. Reprinted with permission.

Crew resource management practices often Therefore, all members of the operating team center on team training and building to prepare must understand team member responsibilities and for crisis situations (France et al, 2008). roles and actively participate in managing this event. Teamwork and task sharing are important to master before a crisis because most health care providers Treatment guidelines are specialists and have limited understanding of Specific treatment guidelines are essential in the their colleagues’ responsibilities (Sundar et al, 2007). management of an MH crisis. The Malignant Hyper- Responding to an MH crisis demands multiple thermia Association of the United States (MHAUS) activities to be executed concurrently, which can provides treatment guidelines, which are generally have a severe impact on a limited staff. accepted in anesthesia practice (sidebar).

32 The OR Management Series Patient Safety in the OR A task distribution worksheet Anesthesia technician Treating the patient in an MH crisis is complicat- The anesthesia technician functions as a sup- ed and potentially manpower-consuming. Cogni- ply and delivery agent. The anesthesia technician tive aids that outline the necessary steps can be help- is responsible for bringing supplies to the room, ful (Harrison et al, 2006). Principles of crisis resource specifically, the MH cart, i-STAT machine with management, crew resource management, and task appropriate items for lab work, bags of ice, extra distribution assignments can also be applied. rescue medications from pharmacy, and sterile Previous authors have developed task distri- water with tubing for the reconstitution of the bution assignments using a model employing Dantrolene. The anesthesia technician also primes strictly nursing personnel (Hommertzheim, 2006). the sterile water line through a fluid warming Ziewacz et al described crisis checklists outlin- device to speed reconstitution of the Dantrolene. ing steps for operating room emergencies, including MH. The current literature has not, however, Surgeon outlined a model that delineates specific tasks for The surgeon’s primary responsibility is to particular personnel. cease operating as soon as possible and adminis- This article describes a task distribution ter cold lavage to open cavities. worksheet that highlights and fully utilizes Anesthesia team the skills and cooperation of each member of the operating team, including anesthesiology, The anesthesia team, consisting of the certified the operating surgeon, nursing personnel, and registered nurse anesthetist (CRNA) and anesthe- ancillary staff such as surgical technologists siologist, is ultimately responsible for task distribu- and perfusionists. tion and providing additional assignments to ancil- The MH task distribution worksheet is in- lary personnel as needed. The anesthesia team must: tended to ensure that the roles necessary to treat • instruct the circulator to place an overhead a patient having an MH crisis are fulfilled. The announcement declaring the MH emergency worksheet assigns roles for: and requesting the MH cart be brought to the • the circulating nurse/OR staff operating room • anesthesia technician • cease all trigger agents and hyperventilate the patient with 100% oxygen via a bag valve mask • anesthesia team separate from the anesthesia machine. • surgeon • calculate, reconstitute, and deliver an appro- • ancillary personnel. priate dose of Dantrolene. Color-coded sections Initial doses of Dantrolene of 2.5 mg/kg up to 8-10 mg/kg (24-hour limit of 30 mg/kg) repeated The task worksheets are printed on half-sheets serially as necessary is accepted as the definitive of laminated paper joined with a ring, allow- treatment (Guranluoglu et al, 2009). The initial ing each party to take a color-coded section that dose in an average adult requires the reconstitu- pertains to his or her individual responsibilities tion of 9 vials of Dantrolene, which consumes the during the MH event (sidebar, p 20). greatest manpower. Though the MH task distribution worksheet was Warming devices are discontinued, and lab- created using the staff mix of our current facility, it work is obtained. A nasogastric tube is also should be viewed as a dynamic model that can be placed by the anesthesia team to allow for cold tailored to any surgical venue or staffing model. saline lavage. Acidosis is treated, and hydration is Task distribution roles maintained with further treatment administered as indicated by the MHAUS recommendations. The roles of OR personnel are distributed as follows: Additional and ancillary staff Circulating nurse These staff should be assigned to mix Dan- trolene; insert invasive monitors as indicated, The circulating nurse/OR staff member such as an arterial line or additional intravenous must initiate the call for help and declare an lines; and assist with charting. MH crisis with an overhead page alerting the OR suite that an MH event is occurring. The Introducing the worksheet overhead page must include a request for the The MH task distribution worksheet was MH cart and solicit additional staff for as- formally introduced at a joint staff meeting sistance. The circulating nurse also calls the consisting of members of the anesthesiology MHAUS hotline to allow the anesthesia team service, OR nursing personnel, surgical tech- to concentrate on treatment tasks. In addition, nologists, and ancillary staff. A slide presenta- the circulating nurse is responsible for assisting tion covered the basic pathophysiology of MH with Dantrolene reconstitution, obtaining sup- and treatment modalities. plies needed for cold lavage, and placing a Foley The MH task distribution worksheet was catheter if required. presented with time for questions and answers

Patient Safety in the OR The OR Management Series 33 about the implementation of the worksheet dur- Harrison T K, Manser T, Howard S K, et al. Use of ing the actual emergency. Hands-on scenarios in Cognitive Aids in a Simulated Anesthetic Crisis. the ORs allowed staff members to interact and Anesth Analg. 2006;103(3):551-556. collaborate as they worked through simulated Hommertzheim R, Steinke E E. Malignant hyper- MH scenarios. thermia—the perioperative nurse’s role. AORN Since that time, new employees are intro- J. 2006;83(1):149-156, 159-160, 162-144; quiz 167- duced to the MH task distribution worksheet in 170. small group training and orientation sessions. The Hopkins P M. Malignant hyperthermia: pharmacol- training program has extended beyond the main ogy of triggering. Br J Anaesth. 2011;107(1):48-56. OR to other areas where anesthesia care is provided, including gastroenterology, endoscopy, Kim T W, Nemergut M E. Preparation of mod- and the outpatient surgery center. ern anesthesia workstations for malignant Because MH is rare, the tool has not been for- hyperthermia-susceptible patients: a review of past and present practice. Anesthesiology. mally used during a real-life MH crisis event. A 2011;114(1):205-212. pilot study quantifying the perceived benefits of this tool in practice is under development. McConaughey E. Crew resource management in MH is an extremely dangerous medical condi- healthcare: the evolution of teamwork train- tion requiring prompt intervention. Ziewacz et ing and MedTeams. J Perinat Neonatal Nurs. al imply that interventions should be instituted 2008;22(2):96-104. within 3 to 7 minutes of the onset of the MH crisis Malignant Hyperthermia Association of the US. to improve the outcome. The task distribution Emergency Therapy for Malignant Hyperther- worksheet is a guide to promote efficient and mia, Available at www.mhaus.org/healthcare- rapid intervention during an MH crisis, ensuring professionals/ that each team member rapidly completes essen- Rosero E B, Adesanya A O, Timaran CH, et al. ❖ tial tasks in an organized manner. Trends and outcomes of malignant hyperthermia —Christopher D. Johns, CRNA, DNP in the United States, 2000 to 2005. Anesthesiol- —Rebecca S. Stoudt, CRNA, DNP ogy. 2009;110(1):89-94. —Michael P. Scholtis, CRNA, DNP Rudy S J, Polomano R, Murray W B, et al. Team —Theodore Gavel, CRNA, MSN management training using crisis resource Geisinger Medical Center, management results in perceived benefits Danville, Pennsylvania by healthcare workers. J Contin Educ Nurs. 2007;38(5):219-226. A photo of Geisinger’s color-coded task cards and Sundar E, Sundar S, Pawlowski J, et al. Crew re- an Excel spreadsheet are in the OR Manager Toolbox source management and team training. Anesthe- at www.ormanager.com siology Clin. 2007;25(2):283-300. References Wappler F. Anesthesia for patients with a history of France D J, Leming-Lee S, Jackson T, Feistritzer N malignant hyperthermia. Curr Opin Anaesthe- R, Higgins M S. An observational analysis of siol. Jun 2010;23(3):417-422. surgical team compliance with perioperative Ziewacz J E, Arriaga A F, Bader A M, et al. Cri- safety practices after crew resource management sis checklists for the operating room: devel- training. Am J Surg. 2008;195(4):546-553. opment and pilot testing. J Am Coll Surg. Gurunluoglu R, Swanson J A, Haeck P C. Evidence- 2011;213(2):212-217 e210. based patient safety advisory: malignant hyperthermia. Plast Reconstr Surg. 2009;124(4 This article originally appeared in OR Manager, Suppl):68S-81S. June 2012;28:18-21.

34 The OR Management Series Patient Safety in the OR Raising the bar for safety in the handling of surgical specimens

s this specimen fresh or frozen? Is it routine, that all specimens intended to be delivered to or does it require a lung protocol? Does it go the lab actually were delivered. Ito the frozen section lab or the microbiology The OR secretary makes sure the transporter department? brings a copy of each requisition back from the Proper labeling and handling of surgical speci- lab. The lab requisition was revised to include an mens are critical to reduce the risk of misdiagno- extra copy for the binder. sis and the need for repeat surgery. “This has been helpful on a couple of occasions Decreasing specimen-handling defects is one to clarify questions,” notes Raynor. goal of the Michigan Health and Hospital Asso- ciation (MHA) Keystone: Surgery collaborative, Tracking specimen data which aims to reduce surgical complications and The Sparrow OR in collaboration with the lab mortality by 5%. tracks specimen data so the number and types of The collaborative has made a difference: The errors can be identified using a tool developed by defect rate declined by more than 50% from 3.18% Keystone: Surgery. to 0.46% from 2010 to 2011. Keystone: Surgery “If we see any trends, we can hone in on members from 3 hospital systems described their what’s happening and correct it,” says Raynor. efforts to improve specimen handling. Early in the collaborative, Raynor says the OR saw process errors decline to zero over a Ensuring a specimen 6-month period because of improvements identi- chain of custody fied through the tracking information. Sparrow Hospital in Lansing, Michigan, had “We have learned we have to keep our finger begun improving specimen safety before joining on the pulse” to spot and correct any errors, she Keystone: Surgery in 2010. Using failure mode says. It’s also necessary to reinforce the new pro- and effects analysis (FMEA), a team had identi- cess with the staff and physicians. A safety board fied what needed to be fixed or improved. in the OR reports a running count of days without “Becoming part of Keystone has enhanced our specimen errors and communicates any safety in- process even further,” says Lynn Raynor, MSN, formation and lessons learned from errors. RN, CNOR, clinical nurse specialist, surgical services at Sparrow. Learning from defects One improvement is a process to ensure the A learning-from-defects tool has been instru- chain of custody for a specimen: mental in preventing errors, says Mary Pride, • The chain begins when the surgeon hands a BSN, RN, department manager. The tool is part of specimen to the surgical technologist (ST) and the Comprehensive Unit-Based Safety Program tells the ST what the specimen is and what (CUSP) and is provided by Keystone. process is needed in the lab. The tool guides caregivers and leaders through a defect analysis to identify what contributed to • The ST hands off the specimen to the circulat- the defect and how to prevent it from recurring. ing nurse, repeating what the surgeon said. This tool helped identify a potential source • The nurse labels the specimen container and of errors by the OR assistant who transports places the specimen in the container. specimens to the lab. He noted that he often was • The nurse completes the tissue requisition and distracted by a phone call to pick up a frozen sec- initials it. The requisition is also initialed by the tion that must be delivered to the lab immediately transporter and the lab person who accepts the while he was reconciling routine specimens in the specimen. specimen room to take to the lab. • During the debriefing at the end of the case, The solution was to declare a “no-distraction the circulating nurse announces all specimens zone” when the OR assistant is reconciling speci- obtained; if no specimens were obtained, that mens, says Pride. Before entering the specimen is also announced. room, the assistant gives up his phone to focus on ensuring consistency between the specimen • A copy of the lab requisition is filed by date requisitions and the tissue log. He then takes in a binder at the OR front desk, in a step sug- those specimens to the lab and does not pick up gested by an OR secretary. This helps ensure

Patient Safety in the OR The OR Management Series 35 SURGICAL SPECIMEN SUBMISSION

ROUTINE FROZEN LYMPHOMA LUNG MICROBIOLOGY PROTOCOL SECTION WORK-UP PROTOCOL SPECIMEN ROUTINE FROZEN LYMPHOMA LUNG MICRO

No Fix No Fix No Fix No Fix No Fix

NO FIXATIVE NO FIXATIVE NO FIXATIVE NO FIXATIVE NO FIXATIVE

deliver to deliver to deliver to deliver to deliver to FROZEN FROZEN FROZEN FROZEN MICROBIOLOGY SECTION LAB SECTION LAB SECTION LAB SECTION LAB DEPARTMENT

Mon-Fri, 8am-5pm: notify Pathology before for assistance leave at frozen Monday-Friday, 8am-5pm – CALL 161279 Mon-Fri, 8am-5pm: section window CALL 16..... Off-hours and weekends – PAGE On-call staff: 3300 (Resident) or Off-hours and weekends: 2281 (Pathologist) Off-hours and weekends: leave in frozen PAGE On-call staff section refrigerator at 3300 (Resident) or 2281 Generic label for additional requests No Fix (Pathologist)

The specimens are labeled with a color-coded sticker for time- sensitive or special-handling specimen streams

A color-coded specimen submission form created by the Henry Ford Health System.

his phone until he returns to the OR. Another OR had a good idea of what was missing and what assistant covers the phone while he is gone. was needed.” “The learning-from-defects tool has been super-helpful,” says Pride. Videos aid communication She notes that in discussing a defect, “we make In their work, the Henry Ford teams learned sure everyone understands that it’s absolutely surgeons and nurses did not necessarily com- nonpunitive and is for our learning to prevent municate complete information about specimens. further errors.” The surgeon identified the specimen as it was taken from the patient, but the nurse didn’t al- Standardizing processes ways hear the surgeon or know how to spell the At the Henry Ford Health System in Detroit, name of the specimen. Michigan, the OR, pathology, and laboratory To illustrate the correct process, D’Angelo medicine have worked together to standardize filmed a training video for the nurses on how to processes, notes Rita D’Angelo, MS, CQE, SSBB, collect and label the specimens. manager, Quality Systems Division, Pathology “The nurses were thrilled with it, but they sug- and Laboratory Medicine. gested the surgeons also needed to see it,” she says. D’Angelo is managing 2 teams of nurses, pa- She made a second video in which a surgeon thologist assistants, and quality specialists with spoke to the surgeons about what was required in the goal to create one standard approach to col- handing off a specimen to make sure the circulat- lect, label, and deliver specimens to the lab. ing nurse knew the correct information. Henry Ford had begun looking at specimen The surgeons pointed out that after they call defects long before it joined Keystone: Surgery out the specimen, they move on to another part and realized the pathology lab received a consid- of the procedure and may not have time to make erable amount of inaccurate or incomplete infor- sure the nurse heard the specimen information mation from other departments, says D’Angelo. correctly. The nurses noted that they and the “We realized we didn’t have a clearly defined surgeons did not use the same nomenclature standard of work or training on either side. We for specimens, leading to the realization that the had defective processes,” she says. In starting to pathology department had not provided a list of working with Keystone: Surgery, “We already specimen types for reference.

36 The OR Management Series Patient Safety in the OR “Training the surgeons and getting them in- • If circulating nurses are gathering multiple volved were milestones, but we’re realizing other specimens for frozen sections, they must call things we still have to do,” says D’Angelo. the OR desk to send help, which could be a floating RN, an ST, a manager, or an educator. Developing standard work To develop standard work, 3 teams of nurses Communicating with pathologists and pathology personnel are observing processes As the pathologists have begun requiring new in both departments. The teams will then develop tissue-handling processes for certain specimens, a standardized process to handle specimens in the communication and education with the patholo- OR and hand them off to the lab. At that point, gists are “doubly important,” says Wills. they will include the surgeons. All will vote on An example is requiring certain specimens, the process to adopt. The physician steering com- such as lung tissue, to be transferred in a sterile mittee will roll out the process to the rest of the manner, which had not been done before. clinicians and staff. The head of the pathology department gave The standardized process will be included in an in-service session for the OR staff about the OR’s new Epic software, which will automate the new processes. The OR had to determine the requisition and submit it to the lab electroni- which sterile containers to use to transfer cally. When the lab receives the specimen, the specimens because some of the lung tissue requisition will be waiting. samples were large. Meanwhile, the IT department is creating a site At the beginning, bone jars intended for using Microsoft’s Sharepoint software. Circulat- large bone flaps were used, but the $10 cost ing nurses will document their frozen sections, was prohibitive. Instead, the staff decided to and the information will be viewed in the frozen use a sterile basin covered with a sterile adhe- section room so lab personnel know what speci- sive drape. mens are coming out of each OR. Another staff idea was color-coded speci- As part of standard work, the OR has intro- men requisitions. Bright yellow requisitions are duced a color-coded labeling system to denote now used for specimens that require special the tissue type and test (illustration, p 10). handling, such as frozen sections and breast When the lab receives the specimen, it knows specimens sent fresh that need to be processed what test is needed and where the specimen within an hour. The requisition for routine needs to go. Each OR has a poster of the color- specimens is white. coding system. Included on the special-handling requisition Standardizing the process requires time and are: effort, D’Angelo notes, but it has lowered the • reason for evaluation specimen defect rate to about 2 a week from about • OR number 40 a month before the Keystone project began. • name of circulating nurse Steps to guide handoffs • name of surgeon who requested special handling Marquette General Hospital in Michigan’s Upper • time placed on dumbwaiter lift to the lab Peninsula has revised its specimen handoff communication protocol based on its involvement with Key- • test requested. stone, says Patricia Wills, BSN, RN, CNOR, director The goal is to decrease requisition errors to 0 of clinical education for perioperative services. to 1 per month, a goal that is being met in most ❖ Although there had been a policy on handoff months. communication for specimens, it wasn’t necessar- —Judith M. Mathias, MA, RN ily followed, Wills notes. She and team members educated the staff about the process and developed these steps: More on Keystone: Surgery is at www.mhakey- • The surgeon calls out the name of the specimen; stonecenter.org/surgery_overview.htm. the ST repeats the name to the circulating nurse; the nurse repeats back the specimen name and receives verification from the surgeon. • Music is to be turned down and conversation This article originally appeared in OR Manager, held to a minimum during specimen collection. August 2012;28:1, 9-11.

Patient Safety in the OR The OR Management Series 37 Safety, cost savings, simplicity back broader use of bloodless surgery

ore than 120 centers throughout the US The Witness community provided organiza- have bloodless surgery programs to tional support for the program as it was being Mserve patients who refuse blood transfu- established, which includes a medical director, sions for religious and other reasons. The practice, nurse coordinator, secretary, and an administra- which began more than 50 years ago, has evolved tive coordinator. through research on blood conservation and new “We put together hospital protocols and poli- techniques to minimize the need for transfusions. cies to help streamline the process, so when The Joint Commission is taking a serious patients who want to avoid blood transfusions look at reducing transfusions, which could spur come to us, we can immediately tell them the pro- the growth of blood management and bloodless cedures we offer,” says Dr Zawadsky. surgery programs across the country, says Mark More than 200 patients a year undergo blood- Zawadsky, MD, medical director of the Bloodless less surgery at Georgetown, and about 10% come Medicine and Surgery program at Georgetown from outside the Witness community. In the past University Hospital in Washington, DC. year, Dr Zawadsky, an orthopedic surgeon, per- Blood management has also attracted the at- formed some 25 hip and knee replacements in tention of the AABB (formerly the American As- patients in the bloodless program. sociation of Blood Banks) and the Department of “A lot of what we are doing is simply basic good Health and Human Services (HHS). medicine, and it doesn’t have to be just for patients who are bloodless surgery patients. All patients can Many transfusions unnecessary, costly benefit from these techniques,” he says. The HHS Advisory Committee on Blood Safe- When starting a program, Dr Zawadsky rec- ty and Availability issued findings and recom- ommends involving the anesthesia department. mendations in June 2011. Anesthesiologists evaluate patients preoperative- Among the findings was that too many pa- ly, manage them during surgery, and follow up tients are receiving blood transfusions that they with them in the postanesthesia care unit (PACU). don’t need, putting them at risk, wasting limited He believes that if you have an anesthesia cham- blood resources, and raising costs. pion to push the benefits of giving less blood, More than 15 million units of whole blood and surgeons may be encouraged to operate this way. red blood cells are transfused annually in the US according to HHS, and as many as 30% of transfu- Major strategies sions may be unnecessary. Bloodless surgery at Georgetown and other In 2011, the Implementation Guide for The hospitals consists of 3 strategies (sidebar): Joint Commission Patient Blood Management • Preoperative anemia management—adminis- Performance Measures was developed to tar- tering IV iron or Procrit (epoetin alfa, a syn- get indications and screening for blood trans- thetic form of the protein human erythropoie- fusions (http://www.jointcommission.org/ tin that stimulates bone marrow to make more patient_blood_management_performance_mea- red blood cells) and discontinuing antiplatelet sures_project/). medications and supplements. Though use of the measures is not an ac- • Intraoperative techniques to minimize loss of creditation requirement, participants at a national red blood cells—normovolemic hemodilution summit on overuse of blood transfusions, held in and cell salvage. 2012 by the American Medical Association and the Joint Commission, called for implementation • Postoperative conservation of patients’ blood of the measures at the local and national levels. and anemia management—restriction of blood draws for lab tests and administration of IV iron or ‘Build it and they will come’ Procrit if necessary. Several hospitals have been pioneers in blood- “The strategies we use to prepare patients less surgery. for bloodless surgery are low-tech and common Three years ago, Georgetown University Hos- sense,” says Patricia Ford, MD, an oncologist/he- pital responded to the needs of the Jehovah’s Wit- matologist and medical director of the Center for ness community, which lacked a bloodless center Bloodless Medicine and Surgery at Pennsylvania in the DC area. Hospital, Philadelphia.

38 The OR Management Series Patient Safety in the OR Evidence on transfusions Mounting evidence supports concerns about blood transfusions. • Data on more than 48,000 surgical patients at Johns Hopkins found frequent transfusions were given to patients who didn’t need them. Transfusions varied 3- to 4-fold among surgeons (Frank S M, Savage W J, Rothschild J A, et al. Anesthesiology. 2012;117:99-106). • In an analysis of nearly 941,500 surgical procedures in the American College of Surgeons National Sur- gical Quality Improvement Program database, patients who received 1 unit of blood intraoperatively had higher rates of mortality and more serious morbidity. These rates increased further with transfusions of more than 1 unit (Ferraris V A, Davenport D L, Saha S P, et al. Arch Surg. 2012;147:49-55). • A comparison of Jehovah’s Witness patients who refused blood transfusions with non-Witness patients who underwent cardiac surgery at the Cleveland Clinic between 1983 and 2011 showed that Witness patients had significantly lower rates of myocardial infarction, additional operations for bleeding, and prolonged ventilation, along with shorter intensive care and hospital stays (Pattakos G, Koch C G, Brizzio M O, et al. JAMA Intern Med 2012;172:1154-1160). • Examining hospital variability in the use of blood transfusions in patients undergoing major noncardiac surgery at academic medical centers between 2006 and 2010, researchers observed dramatic hospital variability. Because of potential complications associated with transfusions, reducing this variability may result in improved surgical outcomes, the authors say (Qian F, Osler T, Eaton M P, et al. Ann Surg. 2013;257:266-268).

Every year, Dr Ford guides some 700 patients ommends industry-wide standardization of blood through procedures from heart surgery to hyster- utilization practices. ectomies without transfusions. Ozawa notes that, conceptually, blood is “re- About 95% of Dr Ford’s patients decline a ally a liquid organ transplant that’s treated as a transfusion based on religious convictions, but an medicine used to manage anemia. It is the only additional 5% decline for other reasons, such as transplant that can be administered by nurses.” fear of bloodborne infections. Autologous blood not used Blood management cost-effective Preoperative autologous blood donation is not “Blood is expensive—costing about $1,100 to used for patients in bloodless surgery programs. acquire and administer 1 unit,” says Sherri Ozawa, “All it does is make the patient anemic,” says RN, clinical director of the Institute for Patient Dr Ford. Blood Management at Englewood Hospital and Many patients mistakenly believe that their Medical Center in Englewood, New Jersey. own blood is 100% safe because it’s theirs, she “If a hospital’s blood budget is $5 million a says. However, human error can make any trans- year, and they decrease it by 10% to 20%, that is a fusion risky. The lab can confuse the blood sam- significant savings,” she says. ples, the blood bank can issue the wrong unit of Research by Ozawa and colleagues (Shander blood, or the nurse or physician can administer et al, 2010), found annual expenditures for blood the blood to the wrong patient. The blood bank and transfusion-related activities for surgical pa- may not label the blood correctly, store it cor- tients ranged from $1.62 million to $6.03 million rectly, or return it to the correct patient. per hospital. A new Johns Hopkins study on shelf life (Frank Englewood Hospital started its bloodless sur- et al, 2013) found that red blood cells stored lon- gery program in 1994, and 2 years later, blood use ger than 3 weeks begin to lose their capacity to had dropped by 40%. deliver oxygen to tissue, and these changes are not readily reversible after transfusion. Transfusion poses risks “When blood is stored for a prolonged period Evidence is growing that blood transfusions of time, the red cells deteriorate,” says Dr Ford. are associated with increased postoperative mor- “They lose enzymes, and don’t carry oxygen as bidity and mortality (sidebar). well as they should. They also become deformed According to the most recent National Blood and don’t travel through small blood vessels as Collection and Utilization Survey, funded by well as they should.” HHS and conducted by the AABB, the annual number of adverse effects from transfusions that Transfusion restrictions required any diagnostic or therapeutic interven- In March 2012, the AABB released a clinical tion was 60,110, or 1 in 394 transfusions. practice guideline on red blood cell transfusion that In 2012, the health alliance Premier found that focused on a restrictive transfusion strategy and use of blood products beyond a level deemed the use of patient symptoms as well as hemoglo- medically necessary can increase complication bin concentration to trigger transfusions (http:// rates and length of hospitalization. Premier rec- annals.org/article.aspx?articleid=1103943).

Patient Safety in the OR The OR Management Series 39 A hemoglobin transfusion trigger of 10 g/dL • Don’t transfuse based solely on a number; had been the standard since the 1940s. use clinical assessment as to whether a unit of The first study to challenge this standard, the blood is necessary. Transfusion Requirements in Critical Care (TRICC) • Don’t automatically order 2 units of blood; trial, was performed in 1999 by Hebert et al. The give 1 unit and reassess the patient before or- study compared outcomes in intensive care pa- dering a second. tients transfused when hemoglobin concentrations Applying these principles across the spectrum dropped below 7 g/dL (restrictive group) and of surgical care could dramatically reduce all pa- those transfused when hemoglobin concentrations tients’ exposure to donor blood. ❖ were below 10 g/dL (liberal group). The restric- —Judith M. Mathias, MA, RN tive group had lower overall 30-day mortality and lower in-hospital mortality rates. References A 2011 study by Carson et al confirmed these Carson J L, Grossman B J, Kleinman S, et al. Red blood findings and showed the results also apply to el- cell transfusion: A clinical practice guideline from derly surgical patients with cardiovascular risks. the AABB. Ann Intern Med. 2012;157:49-58. More than 2,000 hip fracture patients with a http://annals.org/article.aspx?articleid=1103943 cardiac history were transfused at either a hemoglobin of 10 g/dL or <8 g/dL. Results showed Carson J L, Terrin M L, Noveck H, et al. Liberal or no difference between the 2 groups in morbidity, restrictive transfusion in high-risk patients after mortality, or rehabilitation milestones, but wound hip surgery. N Engl J Med. 2011;365:2453-2462. infection rates were almost twice as high for the Frank S M, Abazyan B, Ono M, et al. Decreased more liberal strategy of 10 g/dL. erythrocyte deformability after transfusion and the effects of erythrocyte storage duration. Anes- Are triggers necessary? thes Analges. Published online February 28, 2013. “A patient’s hemoglobin can go very low, and Hebert P C, Wells G, Blajchman M A, et al. A mul- the body can still support adequate tissue oxy- ticenter, randomized, controlled clinical trial of genation, and the patient can survive without a transfusion requirement in critical care (TRICC). transfusion,” says Dr Ford. N Engl J Med. 1999;340:409-417. Pennsylvania Hospital statistics from 2007 showed that in patients with hemoglobins of 4 g/ Implementation Guide for the Joint Commission Patient Blood Management Performance Measures 2011 dL, no deaths were directly related to withhold- ing blood products. Even at hemoglobins of 2 g/ http://www.jointcommission.org/patient_blood_ dL and 3 g/dL, survival rates were 50% and 70%, management_performance_measures_project/ respectively, says Dr Ford. Joint Commission National Summit on Overuse: The hospital saw the number of transfusions September 24, 2012. immediately lowered by 10% when it modified its guideline from 8 g/dL to 7 g/dL about 2 years http://www.jointcommission.org/multimedia/ ago and began requiring the physician ordering national-summit-on-overuse-dr-rosof/ the transfusion to cite a reason if the hemoglobin Koch C G, Li Liang, Sessler D I, et al. Duration of was above 7 g/dL. An additional modification to red-cell storage and complications after cardiac order 1 unit of blood at a time and reassess the surgery. N Engl J Med. 2008;358:1229-1239. patient before ordering a second unit also helped Premier. Best practices in blood utilization. October 2012. lower the number of transfusions. Georgetown’s trigger for transfusion is a he- https://www.premierinc.com/about/news/12- moglobin of 7.5 g/dL, and staff now order and oct/blood_white_paper_207pm_10032012.pdf transfuse 1 unit of blood, then check the hemoglo- Shander A, Hofmann A, Ozawa S, et al. Activity-based bin before ordering a second unit. costs of blood transfusions in surgical patients at Englewood Hospital’s policy does not have a four hospitals. Transfusion. 2010;50:753-765. hemoglobin level trigger for transfusion, but most US Department of Health and Human Services physicians use 7 g/dL, says Ozawa. Advisory Committee for Blood Safety and Avail- “We believe the decision to transfuse needs to ability: 40th Meeting Minutes, June 8, 2011. be a physiological decision, not a numbers-based decision. There are patients who do fine with a http://nih.granicus.com/DocumentViewer. hemoglobin of 5 g/dL and others who have prob- php?file=nih_279c20e5-c8ef-4e28-b457- d86995ff40fa.pdf lems at 11 g/dL.” US Department of Health and Human Services and Simple strategies AABB 2009 National Blood Collection and Utili- Strategies for bloodless surgery patients are zation Survey Report. simple to implement, can decrease unnecessary http://www.aabb.org/programs/biovigilance/ blood transfusions, and can save on health care nbcus/Documents/09-nbcus-report.pdf costs for all patients, says Dr Ford. These include: • Correct anemia preoperatively. This article originally appeared in OR Manager, • Eliminate unnecessary blood tests. May 2013;29:1, 6-9. 40 The OR Management Series Patient Safety in the OR Solid OR governance is the foundation for safety

Ten Elements of Safer Surgery. First in a series. “The best method I have witnessed [for governance] is to have medical and operational staff hat’s the essential ingredient for an OR participation with board guidance and support,” to run safely and effectively? Many Stroud says of his experience there. As heads of Wwould sum it up with one word—lead- the system’s surgical services clinical program, ership, followed closely by collaboration. he and the medical director of perioperative An OR led by a strong team from surgery, services led goal setting and planning initia- nursing, and anesthesia backed by the hospital’s tives, worked with individual hospitals on those top management places a hospital in a stronger initiatives, and sat on committees that included position to meet financial and quality goals. board members. This is the first article in a series on safer sur- For Advocate Health Care, OR governance is gery, which will cover the components needed to central to the SaferSurgery initiative. The initia- strengthen performance in perioperative services tive is aligned with the system’s goals to provide on advancing the quality of care and services. The superior patient outcomes and become the best series is based on the SaferSurgery initiative of system nationally. Advocate Health Care, a Chicago-based health system with 10 hospitals (sidebar). Build a solid structure Several experts advocate this model for periop- Leadership and safety erative governance: Without a solid governance structure, it’s hard • A Surgery Committee is responsible for setting for a perioperative department to resolve flawed policies and is accountable for seeing the poli- processes that can affect patients. cies are carried out. “I’ve participated in many root-cause analyses • A smaller “executive committee” reports to the over the years,” comments Gary Stroud, MSN, RN, Surgery Committee, carries out the policies, chief clinical officer for Prezio Health. “If you don’t and manages daily operations. have a solid structure, it’s only a matter of time Members of the Surgery Committee should before you’re going to repeat that root-cause analy- include representatives of the senior hospital sis” because core issues tend not to be addressed in administration as well as medical staff and nurs- a systematic, sustainable way. He was operations ing leaders. Depending on the size of the facility, officer for the surgical services clinical program at the executive committee typically consists of the Intermountain Healthcare based in Salt Lake City. perioperative nursing director, an anesthesiolo- There’s emerging evidence that leadership is gist, and a surgeon. Many ORs also have a medi- key to successful adoption of practices like a sur- cal director for the OR, typically a paid position, gical safety checklist. who works in tandem with the surgical services A qualitative analysis of 5 hospitals by the director. (Characteristics of good governance are Harvard School of Public Health published in in the sidebar.) 2011 found effective implementation hinged on leadership persuasion and a coordinated effort Select members carefully to explain the rationale and provide education. Physician membership needs to go beyond Further research is underway. titles, Stroud advises. “You need individuals Experts offer the following factors as keys for a in medical staff leadership roles who come to strong governance structure. meetings and who share passion about moving Align strategic direction forward with evidence-based practices.” Advocate Lutheran General (ALG) Hospital Because surgery is a core service of most hospi- in Park Ridge, Illinois, which helps to lead Advo- tals as well as a revenue and cost center, the stra- cate’s SaferSurgery effort, has a 9-member Surgi- tegic goals of the organization and perioperative cal Services Executive Committee (SSEC) and a services need to be aligned. daily operations team. The surgical services structure at Intermoun- SSEC members include the vice president for tain incorporates all levels of leadership up to and medical management (chief medical officer), the including the board level.

Patient Safety in the OR The OR Management Series 41 Ten components Perioperative for safer surgery governance: Key The components of Advocate Health characteristics Care's SaferSurgery initiative: The surgical enterprise is led by a periop- 1. Perioperative governing body erative governing body that functions like a board of directors. 2. Single path for surgical scheduling Functions 3. Preanesthesia testing (PAT) with standardized protocols/hospitalists The governing body: ■ manages department resources including: 4. Document management system for —OR and postanethesia care unit uti- scheduling and PAT lization 5. Excellence in sterile processing —OR scheduling —block time qualifications and allocation 6. Crew resource management —block time utilization by surgeon 7. Implementation of WHO Surgical and/or group. Safety Checklist ■ 8. Daily huddle monitors and manages key performance indicators with: 9. Error reporting —defined data elements 10. Just culture. —clear definitions —consistent methodology.

Qualifications chief operating officer, the chair of anesthesia, the Governing body members are those who: chair of surgery, the executive service line leader ■ put self-interest second to the organi- for surgery (nursing leader), the OR business manager, the medical director of the main OR, and the zation’s interest ■ chairs of orthopedic and OB-GYN surgery. understand the organization’s finan- The SSEC oversees the block schedule and cial situation budget, monitors operational and quality metrics, ■ are politically astute enforces policy, and sets the agenda for perfor- ■ are effective negotiators mance improvement. ■ are active listeners ■ act as champions Designate a daily management team ■ accept accountability. ALG’s daily management team consists of Cindy Mahal-van Brenk, MS, RN, CNOR, the Compiled from information provided by De- executive service line leader; David Young, MD, an anesthesiologist and medical director of pre- loitte Healthcare Consulting, Sullivan Health- anesthesia testing; and John White, MD, the chair care Consulting, and Surgical Directions. of surgery. Dr Young is also a consultant with Surgical Directions. Leadership has helped to propel Advocate Health’s performance in the American College of Establish responsibility and Surgeons National Surgical Quality Improvement accountability Program (ACS NSQIP). Advocate has achieved supe- Responsibilities and accountability for the Sur- rior results on morbidity and mortality, urinary tract gery Committee and operations team need to be infection, and surgical site infection. The system’s clearly outlined. That extends to policies that gov- performance on quality metrics has also earned fa- ern clinical quality as well as operational issues. vorable reimbursement rates from Blue Cross. The block schedule is an example. No matter how well designed initially, a block schedule “will Keep motivations in mind never be sustained if you don’t have a governance In establishing a governance structure and structure that says, ‘These are the rules. If you don’t selecting committee members, Stroud notes, “You follow them, there will be consequences. If you do need to have an eye toward what motivates ev- follow them, we will do everything in our power eryone who has a seat at the table.” to make your life as easy as possible,’” says Randy Some members will participate because they be- Heiser, MA, of Sullivan Healthcare Consulting. lieve deeply in the organization’s mission and others He adds that in his experience, “98% of sur- because they benefit personally or professionally. geons are happy with that model. They want to

42 The OR Management Series Patient Safety in the OR know the expectations. They want an OR that Data for decision making respects their time.” ALG’s perioperative leadership team monitors Active management is also critical for safety. a variety of reports and dashboards to track how “When front-line OR staff believe in the gov- the department is meeting the system’s metrics ernance structure and are supported for doing for health outcomes, finances, patient satisfaction, the right thing for patients, that is when potential and staff and physician satisfaction. incidents turn into near misses,” Heiser says. “But Transparency is essential for the committee to when nurses believe the only result from speak- be effective, she notes. “You have to bring the is- ing up will be to be chastised by physicians, they sues to the table. I can say anything in that group, will let things go and hope someone else catches and they can say anything to me. We challenge problems. each other continuously to be better and to do “On the other hand, if the governance struc- what’s best for the OR.” ❖ ture backs them, they become strong advocates —Pat Patterson for patients.” References Build in accountability Conley D M, Singer S J, Edmondson L, et al. Effec- At ALG, the SSEC sets direction, monitors tive surgical safety checklist implementation. J progress, and allocates resources for clinical qual- Am Coll Surg. 2011;212:873-879. ity improvement initiatives. Patterson P. Is your leadership team up to Mahal-van Brenk reports to the committee health care reform challenges? OR Manager. regularly on clinical quality measures as well as 2010;26(6):1,6-7. on good catches and any sentinel events. “This information is all shared with them,” she Patterson P. Is your OR’s governing structure up says. If there are outliers in the metrics, members to today’s intense demands? OR Manager. ask, “Where is our gap? How can we hardwire 2008;24(7):1,6-7. this process?” This article originally appeared in OR Manager, January 2013;29:8-10.

Patient Safety in the OR The OR Management Series 43 Stryker’s Neptune recall raises stakes for compliance

trict requirements needed to comply with 2 Ultra worry about the consequences of meeting a recall for the Neptune brand of roving the CMN requirements. Ssuction devices are raising questions and One concern is that the Neptune checklist concern for ORs whose facilities continue to use will divert the surgical team’s attention from the devices. the Joint Commission’s Universal Protocol for The recall of the Neptune Waste Manage- preventing wrong-site surgery, raising the risk ment System from Stryker, used to collect and of an error. dispose of fluid waste, was initiated in June Another worry is that reverting to conven- 2012 after the company received reports of seri- tional methods for fluid waste disposal could ous tissue damage, including 1 death. Hospi- subject OR personnel to the risk of bloodborne tals unable to find a suitable alternative to using pathogen exposure. The Neptune system’s rov- the Neptune 1 Silver and Neptune 2 Ultra were ers collect large amounts of surgical fluids and required to file a certificate of medical necessity flush them away through a docking station (CMN) if they chose to keep using the affected without exposure to the staff. products. Since then, further action has been taken by the Initial recall Food and Drug Administration (FDA) and Stryker. In response to the reports, Stryker in June 2012 Facilities that continue to use the Neptune 1 Silver recalled the instructions for use (IFU) of the Nep- and the Neptune 2 Ultra had to file an update to tune waste management system. their CMN by March 25. The IFU did not specifically warn against con- Under the CMN, these facilities must meet necting the high-flow Neptune suction to a pas- detailed requirements, including a 9-point presur- sive drainage tube. Stryker revised the IFU and gery checklist, or risk having the CMN revoked. in October 2012 instructed customers to educate Though Neptune Gold and Bronze users do not users on the revisions and apply warning labels to need to use the presurgery checklist, they must all Neptune devices, cautioning that the suction is agree to conduct training, ensure personnel are dangerous if not used properly. informed about the incidents, and make sure their Requirements raised devices have warning labels. During its investigation, the FDA also advised Stryker issued stricter requirements on Febru- Stryker that the Neptune 1 Silver and Neptune 2 ary 20 after further incidents occurred in facilities Ultra lacked the necessary regulatory clearance. that continued to use the Neptune models under the CMN. FDA audits found a number weren’t Adverse events complying with the initial requirements. Among The requirements come after the reports of the new requirements are: injuries and death involving incorrect application • Train all users (ie, surgeons, residents, anes- of the Neptune’s high-flow suction. thesiologists, nurses, technicians, health pro- Incidents recorded in the FDA’s adverse fession students) and make them aware of the events database show high-flow suction was risks associated with the device. connected to chest tubes in at least 2 cases • Keep a master list of all personnel who have and to a Jackson Pratt drain in 1 case (http:// been trained on the use of the device. www.accessdata.fda.gov/scripts/cdrh/cfdocs/ • Inform all users that additional adverse events cfMAUDE/search.cfm). have been reported. In one report cited by the FDA, a patient died after the Neptune was connected to the chest tube • Ensure that warning labels are present on each during a pneumonectomy, and the suction pulled device. the heart muscle from its left position in the chest, • Implement a 9-point pre-use checklist, which causing a tear in the aorta. the circulating nurse must complete before every procedure. Stryker will audit these re- Worry about the consequences cords to ensure use of the checklist. Failure OR managers and directors at the facilities that to complete the checklist form is grounds for continue to use the Neptune 1 Silver and Neptune revoking the CMN.

44 The OR Management Series Patient Safety in the OR • Identify a training facilitator for each facility notes. Rather than having fluids always con- to ensure implementation of the checklist, and tained by the rovers, the staff must either apply partner with Stryker for additional training. solidifiers so the canisters can be disposed of as • Complete a business reply form acknowledg- regulated medical waste or dump the canisters ing these actions have been taken. manually, potentially exposing them to blood- In a March 27 update, the FDA acknowledged borne pathogens. This potential for exposure and facilities’ concerns about the requirements but compliance with Occupational Health and Safety simply referred users to the Stryker Neptune Administration regulations are the reasons many website for information to carry them out (http:// facilities adopted enclosed waste management neptunecustomercare.com/). systems such as the Neptune in the first place. A major question is whether the risk to patients Safety issues of using a Neptune system is greater than the risk Though the deaths and injuries that have oc- to staff from emptying canisters of blood and body curred are tragic, the numbers are low consider- fluids, he says. ing the number of Neptune units in hospitals In looking at alternatives, hospitals have ques- and the years they have been used, notes Chris tioned whether they should replace their Nep- Lavanchy, engineering director of the Health tunes with another enclosed waste management Devices Group at ECRI Institute, who says he has system, which might end up having the same discussed the recall with both Stryker and the requirements down the road. FDA. The nonprofit institute began tracking the The FDA has told ECRI Institute that it is not recall last year and has issued alerts and special actively looking at other companies at this time, reports for its subscribers. but that doesn’t mean it won’t in the future, La- “These machines have been used since early vanchy says. 2000, and we’re just hearing about a few of these Regulatory clearance incidents in the last 3 years,” he says. The original FDA clearance was for the How did this happen? Stryker Neptune Gold, he notes. After receiv- The Silver model, which is associated with ing the adverse event reports and looking into several of the events, seems to have a relatively the matter, the FDA determined that because narrow range of vacuum levels (254-483 mmHg), the Silver and Ultra models had somewhat dif- biasing suction toward the high side that could be ferent features than the Gold, they were not injurious when applied to tissue, Lavanchy notes. equivalent and thus required separate 510(k) “Whether that characteristic of the Silver actu- clearance. Whether to apply for a new 510(k) ally was responsible for these incidents, we can’t when a device is modified can be a judgment say, but it has been something people have specu- call for the company, Lavanchy notes. The com- lated about,” he says. pany must determine whether the new model The range for the Gold units is broader (50- entails safety or efficacy issues that warrant a 530 mmHg), and the vacuum level can be turned new 510(k) application. down so the suction is not as powerful. Regulatory status The Ultra model, a newer version of the Gold, has the option of displaying the vacuum level The Neptune-1 Gold and Bronze devices con- in different units of measure—millimeters of tinue to be legally marketed, and there is no mercury (mmHg), inches of mercury (inHg), and change in their status, although the Gold is no kilopascals (kPa). longer being actively marketed, Stryker stated. In the US, mmHg is commonly used, and inHg Regarding the other models: is used rarely; kPa, seldom used in the US, is more • Neptune 1 Silver: The company has decided common in Europe. not to submit a 510(k) and will withdraw this A problem could arise, Lavanchy notes, when model from the market. All support for that the Ultra is inadvertently set on a unit of measure device will stop by March 1, 2014. other than mmHg, which could cause users to • Neptune 2 Ultra: Stryker has submitted a think they are applying a lower level of vacuum 510(k) but does not know when or if the device than they actually are. For example, 250 mmHg will be cleared. The FDA has requested addi- would be 10 inHg and 33 kPa. Again, it’s not tional information. Stryker says it is working to known whether this contributed directly to the respond to the requests. incidents. Stryker and the FDA recommend that users of Regardless of the type of suction applied, he the Neptune 1 Silver and Neptune 2 Ultra transition says, “It is the responsibility of the person using the to a legally marketed device as soon as possible. ❖ suction to verify the level of the suction and wheth- —Judith M. Mathias, MA, RN er that is safe for the tissue you’re applying it to.” Concern about alternatives Reverting to conventional wall suction means This article originally appeared in OR Manager, collecting waste in suction canisters, Lavanchy May 2013;29:16-17.

Patient Safety in the OR The OR Management Series 45 Trauma center’s mortality rate drops dramatically with use of new protocols

rauma events occur every 5 minutes in the pus identified an opportunity to improve care United States, and 30% of trauma patients and developed a more systematic delivery ap- Tdie within 120 minutes of the event because proach for managing trauma patients. of major organ injuries that lead to heavy blood loss. “The main objective was to create a dedicated Better outcomes are achieved when care is ini- trauma OR team and eliminate the need for the tiated within 60 minutes, a time frame commonly circulator to leave the OR,” explains Darlene Mur- referred to as the “golden hour.” dock, BSN, BA, RN, CNOR, Clinical Nurse IV. Because of the rapidly evolving healthcare After instituting the dedicated OR and trauma environment, trauma centers are continually team—among many other protocols led by the af- challenged to improve the care delivery process filiated physician team and the dedicated nursing for critically injured patients. In 2009, Houston’s staff—Memorial Hermann-Texas Medical Center, Memorial Hermann-Texas Medical Center cam- one of the nation’s busiest Level I trauma centers, improved its mortality rate for trauma patients by 62%. “We feel confi- dent that the dedicated OR and trauma teams played a large role in providing more efficient quality care,” adds Murdock. Trauma room designated “Prior to our initiative, we did not have a dedicated trauma OR and staff,” says Mur- dock. There are 39 ORs, she notes. Because trauma happens without notice, the circulating nurse was at times leaving the room to obtain the necessary equipment for the trauma case. To ensure the highest level of care was provided, the leadership team instituted a change. In 2009, the OR director and trauma Checklists and surveys reprinted with permission from Memorial Hermann-Texas chief designated the Medical Center. largest of the 39 ORs

46 The OR Management Series Patient Safety in the OR “We made check- off sheets for both circulators and surgical technicians to ensure nothing was missed,” explains Murdock. “This re- dundant system has served as a tremendous help,” she says. The circulators are accountable for the room setup and must confirm room readiness by turning in completed check- off sheets to the charge nurse at 7 am and 7 pm. “Because of the check-off sheets, supplies and equipment are always in the same place now, so when a surgeon asks for something, you know right where to get it,” says Naomi Brown, BSN, RN, OR surgical nurse III. Trauma team initiated Designating a team of RNs and surgical technicians just for the trauma room for trauma, and after a thorough overview of the has been key to increasing patient safety, efficien- process and best practice, the following changes cy, and surgeon satisfaction, says Laura Keller, were made: BSN, RN, OR clinical manager for the night shift. • The room was reorganized and stocked with “If you are always in the same room, you trauma surgery equipment and supplies. know where things are, you know where things belong, and you know how the room is set up,” • A check-off sheet and protocols were put in notes Keller. Familiarity with the team members place to ensure all equipment and supplies also adds to the trauma surgeons’ comfort level. were present. “When things get tense in the room and the pa- • Supply cabinets were labeled for ease of re- tient is crashing, they don’t have to worry. They trieving supplies. know we know what we need to do,” says Keller. • Computerized rolling trauma supply carts Keller has 4 RNs and 5 surgical technicians were streamlined to ensure efficiency and who rotate through the 12-hour night shift. There complete charge capture. are 10 trauma surgeons. To create the team, Keller • Instrument sets were streamlined, and addi- says she asked the people she knew could handle tional instruments were ordered. the stress of being in the trauma room. “No one told me no,” says Keller, “but they • Supplies were added to the trauma pack to didn’t want to do it every night. That is why we eliminate time spent on opening individual rotate them.” packages. Check-off sheet implemented Surveys show satisfaction Surveys were developed to see how the cir- In 2010 the check-off sheet was updated and culators and trauma surgeons perceived the effi- made more user-friendly, and a second check-off ciency and preparedness of the trauma room and sheet was created—now there is 1 for the circula- team. The surveys were developed by Murdock tor and 1 for the surgical technician, each with in August 2012 to measure the success of the ini- different supplies and equipment to check. tiative. On a monthly basis Murdock and Brown

Patient Safety in the OR The OR Management Series 47 evaluated the results and shared the results with Judging by a 4-month average of results from everyone on the trauma team. This process con- 108 completed surveys, a majority of circula- tinues today; the feedback on how the team oper- tors and trauma surgeons are satisfied with the ates ultimately impacts patient care, which is the trauma room setup. The average score was 4.6 on department’s highest priority. a scale of 1 to 5. After each case the surgeons complete a survey To ensure the hospital continues to move to- to tell the team how the case went and how well ward providing the highest level of quality care, they thought the team worked, says Murdock. Murdock says the team is in the process of imple- “The surgeons want to fill out this survey; they menting AORN’s recommended practice for the ask for it at the end of each case,” she says. trauma room temperature to remain at 85°F until The circulators also fill out the survey, com- the patient becomes normothermic, to help im- menting on the room setup and noting whether prove outcomes. ❖ they had to leave the room for anything. Survey —Judith M. Mathias, MA, RN results indicate a significant decrease in the number of times the circulator has to leave the room for equipment and supplies. “Our survey has really helped us to determine where we are and where we need to go,” says This article originally appeared in OR Manager, Murdock. December 2013;29:20-22.

48 The OR Management Series Patient Safety in the OR II. Handoffs, Briefings, Checklists, Time-outs

Patient Safety in the OR The OR Management Series 49 A cure for the distracted time- out before surgery

oes this ever happen in your OR? The Engaging the team circulating nurse calls for the time-out. The campaign’s first phase was to reinforce DBut the team doesn’t seem to be focus- the 5-step Minnesota Time-Out for every patient, ing. Music is playing, an assistant is draping the every procedure, every time. C-arm, and team members are talking about the Harder says she developed the time-out steps football game. The circulating nurse tries again to engage all team members cognitively. Each and gives up. member has a specific role intended to engage A cognitive psychologist from the University him or her in verifying the correct patient, proof Minnesota says she often saw distracted teams cedure, and site. The time-out steps are based on in OR observations at 8 hospitals in the state. an analysis of the reported errors as well as on The psychologist, Kathleen Harder, PhD, human and cognitive factors that come into play used the findings to develop the Safe Surgery during surgery, such as distractions, interrup- Process to prevent wrong surgery. She is pre- tions, and confirmation bias; that is, the tendency senting the findings and rationale in workshops to see only information that confirms what we as part of the Minnesota Time-Out Campaign. already think is true. The culture of the OR also The campaign, sponsored by the Minnesota plays a role, including a perceived hierarchy that Hospital Association and Minnesota Depart- inhibits team members from speaking up if they ment of Public Health, is part of a 3-year effort have a concern. to end these adverse events. Harder says sharing the research findings and Many time-outs were “completely dysfunc- rationale from cognitive psychology has helped in tional. They just ticked off a list. People weren’t discussing the purpose and merits of preoperative listening,” says Harder, who is director of the verification with skeptical surgeons. Center for Design in Health at the University Carol Hamlin, MSN, RN, director of depart- of Minnesota. The observations at 5 hospitals mental performance for perioperative services at were funded by the Minnesota Department UMMC, Fairview, says she has heard from staff of Health; the University of Minnesota Medi- firsthand that “the rationale makes a world of cal Center (UMMC), Fairview, in Minneapolis difference in willingness to practice the process funded observations at its 3 facilities. as designed.” Progress in prevention These are the key verification steps with the rationale. The project may be starting to bear fruit. The number of days between wrong-site events rose ‘Sources of truth’ from an average of 11 days before the time-out In the preop area, before marking the site, the campaign to about 30 days in the first 6 months surgeon verifies the correct site by consulting the afterward. Overall, wrong-site procedures in “sources of truth”—the consent form, surgeon’s Minnesota fell by 23% to 24 in 2011. orders, and imaging if applicable. If able, the “If this trend continues, it will mark significant patient is asked to state the procedure and site. If progress towards eliminating this nearly always there is a discrepancy with any of these informa- preventable event,” the health department said tion sources, the discrepancy is resolved before in its January 2012 report. More facilities reported the surgeon marks the site. they are using the Minnesota Time-Out both in Rationale: Marking the surgical site from memory and outside the OR. can lead to errors. “Given the fallibility of human Root causes for wrong-site procedures in 2011 memory, relying on memory is not a good idea,” included: Harder says. Though surgeons “may think their • source documents that did not indicate laterality memory is stellar, there’s a lot of evidence it’s not.” • difficulty identifying the correct vertebra for Transport to the OR spinal procedures because of unusual anatomy Before moving the patient to the OR, the per- or multiple degenerated vertebrae son doing the transport double checks that the • lack of a policy for site marking or a time-out site is marked correctly, comparing it with the when administering regional blocks. consent form.

50 The OR Management Series Patient Safety in the OR Step 1 The surgeon calls for the time-out just before the incision after the patient is prepped and draped. “If the surgeon starts the time-out, it shows it is really important, and we are going to do this as a team,” says Kathleen Harder, PhD. “Also, the surgeon knows when he or she is ready to begin the procedure.” When the surgeon calls for the time-out, the team ceases activity.

Step 2 The circulating nurse reads directly from the consent form that was verified during the preop process, stating the patient, procedure, site, and laterality. The nurse does not rely on memory.

Step 3 The anesthesia provider reads the patient’s name from the anesthesia record; states a shorthand version of the procedure, and states the antibiotic, dose, and time from administration. (This is the only part of the time-out not focused on the correct patient, procedure, and site.)

Step 4 The scrub person states a shorthand version of the case he or she has set up for and visualizes the site marking, stating, for example, “I see the site mark on the right knee.” Giving the scrub person a specific role helps to level the hierarchy.

Step 5 The surgeon finishes the time-out from memory, by stating: “This is Mrs Smith, and she is having a right knee arthroplasty.” The reason the surgeon concludes the time-out is to listen to what everyone else has said. At this point, reciting the patient and procedure from memory verifies that the surgeon is cognitively engaged with the correct procedure.

Rationale: “We found that sometimes the patient tive area, the mark must remain visible after prep- was not marked in the preop area and made it all the ping and draping. way to the OR, but nobody said anything,” Harder If the site can’t be marked, as with teeth or says. “That told me the process was not engrained.” ureteral stents, the mark is placed on an ana- tomical diagram that accompanies the patient to Introduce the patient the OR and is referenced during prepping and When the patient arrives in the OR, the transport- time-out. ing person introduces the patient, saying, “This is Rationale: “We found in observations that the Sally Smith. She is here for a right hip replacement.” mark was not always near the site. [Sometimes] it The transporter confirms the patient’s identity was more of a laterality marking, for example, on with the circulating nurse and anesthesia pro- the left arm for a left breast procedure,” Harder vider. They check the patient’s ID band (medical says. That can lead to errors. record number and date of birth) with the consent form and anesthesia record. Streamline the time-out Rationale: This step ensures that the correct The briefing and time-out are separate pro- patient has arrived in the correct OR and that the cesses. The time-out is held as the final check right documents actually belong to that patient. “Some- before the incision. The briefing takes place ear- times, patients can end up in the wrong OR, or the lier. The two were separated because the time-out wrong documents arrive in the OR, and it’s not was “flooded with information,” Harder notes. caught,” Harder notes. “The final safety check was not getting the due An added benefit of the introduction: The pa- diligence it deserved.” tient feels more comfortable. Conducting the briefing earlier also helps the “I’ve gone into places where this is fully imple- case flow. “It’s a little late to discover just before mented, and there is such a difference. The patient the procedure that the necessary equipment isn’t is made to feel at home,” she says. in the OR or that an implant can’t be located.” Rationale: The time-out is held right before the Prep the marked location incision to “address memory confounds that can The site that is marked is the site to be prepped. occur if the time-out is done before the surgeon When the surgeon marks the site in the preopera- scrubs,” Harder says.

Patient Safety in the OR The OR Management Series 51 In some cases she observed, the surgeon would The key to timing the briefing is that all 4 dis- do the time-out and then go out to scrub. ciplines—surgeon, circulating nurse, anesthesia The surgeon might then chat with a colleague provider, and surgical technologist (ST)—must be about another case. present to share the same information. “That can confound the information in the sur- Harder says some surgeons have asked why geon’s head,” she notes. “The surgeon can walk they can’t do a roving briefing; that is, talk sepa- into the OR and do the wrong procedure. That has rately with the circulating nurse, anesthesia pro- happened more than a few times.” vider, and ST. The reason: All parties may not hear the same A role for each person relevant information. In the time-out’s 5 steps, each person has a She once saw an anesthesia provider get upset specific role, with the aim of engaging each team with a surgeon because the surgeon had shared member cognitively and avoiding multitasking information only with the circulating nurse that (sidebar). was also relevant to anesthesia. That led to a prob- The ability to multitask “is a myth in complex lem in the patient’s care. systems,” says Harder. The briefing should not be confused with the Performing the steps in this order has caught case planning that comes earlier. The briefing is more than one prospective error, she says. “In not the time to order equipment, for example. Colorado, where Banner Health has implemented “The preplanning needs to start when the pa- the Safe Surgery Process, it caught an error in the tient is scheduled for surgery. The briefing is the first week it was used.” last-minute verification of the plan,” says Hamlin. The Minnesota campaign has a collection of When to do the briefing? tools to help with implementation at www.mn- At UMMC, Fairview, “we had a lot of discus- hospitals.org/index/timeout. ❖ sion about when to do the briefing,” Harder says. —Pat Patterson “We decided it could be done at any time from the case setup to just before the patient positioning.” Watch a 5-minute video with the model time- The point of the briefing is to ensure that the out at www.mha-apps.com/media/to.html team has the “correct mental model,” she notes. Team members also introduce themselves if they don’t know each other. Research demonstrates that if teams do that, members are more likely to This article originally appeared in OR Manager, speak up if there is a concern. June 2012;28:12-14.

52 The OR Management Series Patient Safety in the OR Adopting a ‘no interruption zone’ for patient safety

he time-out is called, but conversations are going on, and the staff is still assembling Tips: No interruption zone T equipment. No one seems to be listening. (NIZ) Then during the case, the anesthesiologist has trouble hearing over the loud music and chatter. ■ Agree on a term for declaring an NIZ, The circulating nurse needs confirmation on a such as “Delta.” specimen but can’t get the surgeon’s attention. ■ Customize the surgical safety checklist Distractions and interruptions happen in the to include Delta. OR as often as every 3 minutes, studies show. Do these distractions contribute to errors? ■ Have the surgeon reinforce the use of Researchers recently conducted a controlled Delta during the briefing. study to find out. In a lab, 18 surgical residents ■ Conduct interdisciplinary teamwork performed laparoscopic cholecystectomies on a training on use of the NIZ. simulator. Each resident performed procedures both with and without distractions and interruptions. Distractions and interruptions were intro- ing), time-out, and sign-out (debriefing). The duced randomly without residents being aware trigger word can also be used anytime during a of the study’s purpose. In results: procedure when a team member sees something • 8 of 18 (44%) of the participants made major errors amiss or requires quiet. when there were distractions and interruptions During an NIZ, the team: • only 1 of 18 (6%) did so when there were none. • stops all conversation No-distraction strategies • stops all unnecessary activity Some ORs are taking steps to tame distractions • turns down any music during critical periods of cases. One strategy is • addresses the situation in an engaged way. the “sterile cockpit” or the “no distraction zone” “The bottom line is that the NIZ helps you (NIZ), a term more applicable to health care. build a wall between your team and distraction- Aviation adopted the sterile cockpit years ago induced errors,” Harden says. after an analysis of 78 accidents showed 72% were linked to distractions. NIZ: The prerequisites “On average, in aviation, there are 7 warning An NIZ can’t be used in isolation, Harden signs before an accident,” but distractions can stresses. To be effective, it must be part of a cul- keep a crew from recognizing them, says Steve ture of patient safety and teamwork. Harden, an airline captain with LifeWings, who A safety culture accepts that because all pro- has consulted with hospitals on patient safety for cedures are performed by humans, errors will 12 years. occur, no matter what tools or countermeasures The Federal Aviation Administration now has are used. A safety culture is characterized by pro- a rule saying that during critical phases of the fessional support, mutual respect, cross-checks, flight, such as takeoff and landing, no conversa- and the willingness of all team members to speak tions or paperwork not directly related to the up if something seems amiss. flight operation are allowed. Pilots are suspended The record on speaking up isn’t strong. for violations. Based on results of safety climate surveys analyzed by the Agency for Healthcare Research and An NIZ for the OR Quality in 2011, “we know that if any hierarchy As in aviation, an NIZ in the OR is a quiet time is present in the interaction, over 50% of staff will during critical phases of a procedure triggered by not speak up,” says Harden. a word such as “Delta.” Teamwork training, such as education in crew For example, an NIZ can be declared during resource management (CRM) or TeamSTEPPS, an the 3 phases of the World Health Organization evidence-based teamwork system, helps to lay the (WHO) Surgical Safety Checklist: sign-in (brief- groundwork.

Patient Safety in the OR The OR Management Series 53 In the training, interdisciplinary groups of Again, no one stopped. “Then she said, ‘Delta,’ physicians, nurses, and other personnel learn and they all stopped closing and looked up,” principles of patient safety, communication, as- Kadis recalls. The sponge was found with the sertiveness, and other methods that create more placenta in the specimen bucket. cohesive units. “A collegial, interactive team catches and neu- The right word tralizes mistakes, holds one another accountable, It took a surprising amount of time to identify and backs each other up,” Harden notes. the right word for triggering the NIZ. Delta was At Nebraska Medical Center, for example, suggested because of its tie to aviation. before teamwork training, 69% of OR personnel There was considerable discussion about what say they would speak up, he says. That rose to Delta might mean in different clinical areas. Eventu- 93% afterward. ally, consensus developed. Now Kadis says Delta is recognized throughout the Memorial system. Design in the buy-in Safety strategies like the NIZ and surgical Laying the groundwork safety checklists are most likely to be accepted Memorial began building the foundation for a and used consistently if they are designed or safety culture in 2007 when it introduced CRM. modified by front-line clinicians who will actually “That’s the key to success, the willingness to use them. The WHO checklist is intended to be fund training,“ Kadis says. “We brought it in with modified to fit each organization’s needs. full support of the executive team.” Even in the “The key principle is that the people who use a wake of the nation’s economic downturn, Memo- checklist are the ones who design it,” Harden says. rial continues to fund a CRM director position. “A mistake I see a lot of places make in the way CRM training is mandatory for all personnel they design or revise their checklists is to have it in procedural areas, including physicians, and done by administrators in surgical services.” the requirement is included in the medical staff It’s more successful if the checklist is modi- bylaws. Aides, transporters, and unit secretaries fied by a multidisciplinary work group of nurses, also participate in training. techs, and physicians. Physicians must train within 6 months of join- For physicians who sit on the work group, he ing the organization. One cardiologist had his adds, “You have to be crystal clear that they are procedural credentials suspended until he com- representing their peers.” The physicians agree pleted the training class. that they will convey to their peers how the check- The chief medical officer is a driving force. list is to be used. During the rollout of the CRM training, he and Kadis targeted key physicians, visiting their of- Introducing the NIZ fices, making phone calls, and following up to Nearly all procedural areas in the 6-hospital enlist champions. Memorial Health System, based in Hollywood, Florida, have adopted the NIZ, triggered by the Assertiveness for staff word “Delta.” Having the staff feel comfortable with speak- “When someone says ‘Delta,’ it means, ‘I have ing up is essential for safety, Kadis notes. Memo- a problem. Stop,’” says Jenny Kadis, MS, RN, rial’s staff receive training in assertiveness. CPAN, the system’s director of clinical effective- She’s developed real-life scenarios so they can ness. practice. Examples: A safety statement about using Delta is part of • A surgeon preparing to list 15 specimens at the the surgical safety checklist. end of a case says, “Listen, because I’m only During the briefing at the beginning of a case, going to say this once.” How do you respond? the surgeon reminds the team about Delta by say- • A Delta is declared. A vendor who is in the ing something like: “Speak up for safety. Look for OR is on the phone and won’t get off. How do red flags. Use Delta any time.” you handle the situation? (At Memorial, any If the surgeon forgets, anyone else on the team person present in the OR is considered a team can remind the surgeon to make the safety statement. member and is expected to adhere to policies.) Delta is also called anytime during a case when a team member spots a problem. Some examples: Showing the value • A surgical technologist called a Delta when a Physicians need to see there is something for piece of equipment wasn’t working. them in participating, Kadis adds, saying, “We’ve • An anesthesiologist called a Delta when there worked hard to show value.” was a lot of music and chatter, and he needed One way to show value is to record concerns to hear. that arise during debriefings at the end of cases • A labor and delivery nurse called a Delta when and to act on them. a lap sponge was missing while she was count- Circulating nurses fill out a debriefing form. ing on a c-section. The concerns are categorized, recorded in an Excel spreadsheet, and sent to the OR director, First, she said, “A sponge is missing.” who assigns personnel to address them. No one listened. She repeated the statement.

54 The OR Management Series Patient Safety in the OR “That person is responsible for giving an up- Steve Harden can be reached at sharden@saferpa- date to the physician within 72 hours. They don’t tients.com. A recording of his OR Manager webinar, have to be solved by then,” she notes. Eliminating Distraction-Induced Errors, with further tips, can be purchased at www.ormanager.com. Resolutions are recorded and quantified. References Managers report regularly at the Department of Code of Federal Regulations. Title 14. Part 121. Surgery meeting, saying, for example: “In the past Subpart T. Section 121.542. Flight crewmember 6 months, we’ve made 1,100 updates to preference duties. 46 FR 5502. January 19, 1981. www.ecfr. gov/cgi-bin/text-idx?c=ecfr&rgn=div8&view=te cards. We’ve examined the lights in Room 10, and xt&node=14:3.0.1.1.7.20.3.8&idno=14 they’re going to be replaced. We’ve had the vendor provide additional staff training on the video system.” Feuerbacher R L, Funk K H, Spight D H, et al. Re- They also share success stories: “During a alistic distractions and interruptions that impair briefing, we found out a baby was allergic to a simulated surgical performance by novice sur- medication, and only the circulating nurse knew.” geons. Arch Surg. Published online July 16, 2012. doi: 0.1001/archsurg.2012. Turnover time has improved because staff is more prepared for cases. Healey A N. Sevdalis N, Vincent C A. Measuring Business has also improved. After the OR di- intraoperative interference from distraction and rector was able to document 50 delays caused by interruption observed in the operating theatre. insufficient instrument sets for lap choles, the ad- Ergonomics. 2006:49:589-604. ministration approved the purchase of additional Weigmann D A, El Bardissi A W, Dearani J A, et sets, enabling more cases to be performed. al. An empirical investigation of surgical flow Kadis says she can’t overemphasize the need disruptions and their time relationship to surgi- for team training. cal errors. Paper presented at: Proceedings of the “People think CRM is just about building a Human Factors and Ergonomics 50th Annual time-out process,” she says. “But it’s not only the Meeting, October 16-20, 2006. San Francisco, time-out; it’s speaking up; it’s working as a team; California. it’s talking openly. Zheng B, Martinec D V, Cassera M A. A quantita- “There’s so much more than just building the tive study of disruption in the operating room tools. Tools are great. But if you just read a poster, during laparoscopic antireflux surgery. Surg En- and you’re not talking to each other, you might as dosc. 2008;22:2171-2177. well not bother.”❖ —Pat Patterson

A copy of Memorial Health System’s surgical safety checklist with the safety statement is in the OR Man- This article originally appeared in OR Manager, ager Toolbox at www.ormanager.com. February 2013;29:20-22.

Patient Safety in the OR The OR Management Series 55 Has your checklist effort stalled? Some advice on how to restart it

Fifth in a series on ten elements of safer surgery. the checklist meaningfully and monitor its impact. Free resources are at www.safesurgery2015.org. his marks the fifth year since the worldwide Here’s advice to help ensure the checklist con- roll-out of the World Health Organization tinues to be a living document in your ORs. T(WHO) Surgical Safety Checklist. In some hospitals, the checklist has taken root and become A process, not a checklist a way of life. In others, acceptance is slower. For Keep in mind that safe surgery is a process, not others, after an initial burst of enthusiasm, the just a checklist, advises Kathleen Harder, PhD, a checklist has become just a series of tick boxes. cognitive psychologist and human factors expert What’s the difference between a checklist ef- at the University of Minnesota. fort that is alive and one that lags? “The focus is on the process—a checklist alone will For this article, experts, including the Safe Sur- not prevent an error if the process is not done well.” gery 2015 team led by surgical checklist pioneer Harder assisted the Minnesota Hospital Asso- Atul Gawande, MD, offer 12 key factors for en- ciation and the Minnesota Department of Health suring that the checklist fulfills its true purpose— in developing the state’s Safe Surgery Process and serving as a tool to aid team communication and has conducted workshops throughout the state. minimize risks to patients. The process includes a 5-step time-out based on The first question: Was the checklist imple- human factors research and observations in hos- mented effectively to begin with? pital ORs (sidebar). A study of 5 hospitals in Washington State Identify the critical elements indicates the effort can falter without strong leadership by senior clinicians and extensive ed- Modify the checklist to meet the needs of your ucation. Conley et al found effective implemen- organization and individual specialties, and in- tation depended on leaders explaining the ratio- volve the teams that will use the checklist. Teams nale for the checklist persuasively and showing will be more likely to use the checklist if it’s rel- how to use it, along with extensive education, evant to their needs. including demonstrating best practices; pilot “Ask what your critical issues are, and make testing; providing coaching and feedback; and sure those are on your checklist,” advises David anticipating the need for long-term training, ob- Young, MD, director of presurgical testing at Ad- servation, encouragement, and quality control. vocate Lutheran General (ALG) Hospital in Park When leaders didn’t provide this groundwork, Ridge, Illinois, where the checklist is part of the and clinicians didn’t understand the checklist’s Safer Surgery process. rationale or weren’t adequately prepared to use Approach physicians one-on-one it, they became frustrated and disinterested, and use of the checklist fell off, even though the Approaching physicians individually, though hospital mandated its use. time-consuming, is an effective way to get buy-in, Bill Berry, MD, MPH, MPA, program director for Safe Surgery 2015 Safe Surgery 2015, noted in a recent webinar. To foster checklist adoption, the Harvard In working with hospitals, he has found that School of Public Health in Boston, home of Dr 10% to 20% of physicians immediately see the Gawande’s initiative Safe Surgery 2015, has part- checklist as helpful and will actively participate. nered with the South Carolina Hospital Asso- “This is generally where you find your cham- ciation (SCHA) to have all hospitals in the state pions,” he said. adopt the checklist for routine use in their ORs by Of the remaining physicians, about half are the end of 2013. The effort recently expanded to passively compliant and won’t fight the checklist. North Carolina and Virginia. “This is the group I think you can influence with Based on the evidence, Safe Surgery 2015 esti- a one-on-one conversation.” And those who are mates successful implementation and proper use resistant or even hostile might also be persuaded of the checklist could save more than 500 lives per not to actively oppose the checklist if a champion year in South Carolina. explains it to them. The Harvard team offers webinars, conference Safe Surgery 2015 offers these tips for one-on- calls, and other resources to help ORs introduce one conversations: 56 The OR Management Series Patient Safety in the OR Minnesota time-out Step 1 Step 2 administration. (This Step 5 The surgeon calls for The circulating nurse is the only part of the The surgeon finishes the time-out just before reads directly from the time-out not focused the time-out from the incision after the consent form that was on the correct patient, memory, by stating: patient is prepped and verified during the preop procedure, and site.) “This is Mrs Smith, draped. process, stating the pa- and she is having a “If the surgeon starts tient, procedure, site, and Step 4 right knee arthro- the time-out, it shows it laterality. The nurse does The scrub person: plasty.” is really important, and not rely on memory. • states a shorthand The reason the sur- we are going to do this version of the case he geon concludes the as a team,” says Kath- Step 3 or she has set up for time-out is to listen leen Harder, PhD. The anesthesia provider: • visualizes the site to what everyone else “Also, the surgeon • reads the patient’s marking, stating, for has said. At this point, knows when he or she name from the anes- example, “I see the reciting the patient is ready to begin the thesia record site mark on the right and procedure from procedure.” • states a shorthand ver- knee.” memory verifies that When the surgeon sion of the procedure Giving the scrub per- the surgeon is cogni- calls for the time-out, • states the antibiotic, son a specific role helps tively engaged with the team ceases activity. dose, and time from to level the hierarchy. the correct procedure.

• Don’t try to “fix” a physician with the check- “You want to require an answer to each part,” list. The goal is to open their minds, engage explains Cindy Mahal-van Brenk, MS, RN, CNOR, them, and get them to try the checklist. executive service line director for surgery. • Have a respected peer talk with them one-on-one. Here’s an excerpt: Circulator to anesthesia provider: “Would you • If you believe a physician isn’t going to use the please state the patient’s name?” checklist, don’t try to force it. Anesthesia provider: “David Smith.” • Ask the physician not to obstruct others in Circulator: “Please tell me which antibiotic using the checklist. you gave.” (Resources for how to conduct a one-on-one Anesthesia provider: “I gave 1 g Ancef at 15:30. conversation are at www.safesurgery2015.org.) Circulator: “Is the patient on a beta-blocker?” Peer pressure can make a difference. Anesthesia provider: “No beta-blocker is One ambulatory surgery center posted a photo indicated.” of each physician who agreed to try the checklist, Circulator to the surgeon: “Dr Jones, please state notes Lizzie Edmondson, senior project manager the procedure you will be performing.” for Safe Surgery 2015. Surgeon: “I am performing a left hemi-arthro- When one hold-out asked why his photo plasty.” wasn’t posted, he was told, “Those are the people Circulator: “Is the site marked?” who are checklist champions.” He agreed to try Surgeon: “The site is marked.” the checklist so his photo could be displayed. Add teamwork training Give each team member a role Team training provides a foundation for com- “We have speaking parts for the surgeon, an- munication, the checklist’s fundamental purpose. esthesiologist, and nurse,” says Jennifer Misajet, Studies show combining team training with the MHA, RN, CNOR, regional director of periop- checklist improves outcomes. erative services for Kaiser Permanente’s Northern In a pilot study led by Bliss et al, use of a California region based in Oakland. checklist plus structured team training pro- “If you have a speaking part, you are more en- duced a statistically significant difference in gaged because you have something to contribute 30-day morbidity. The report is in the Decem- to the activity.” ber 2012 Journal of the American College of The Kaiser region has embedded the check- Surgeons. list as part of its Highly Reliable Surgical Teams In a study of 74 facilities in the Veterans Health (HRST) initiative, which involves all of the re- Administration published in 2010, Neily and gion’s medical centers. colleagues found an 18% reduction in mortality Advocate Lutheran General uses a challenge- when team training and the checklist were com- and-response approach for the OR portion of the bined. checklist.

Patient Safety in the OR The OR Management Series 57 stalled on their iPads and customized for tracking Safer Surgery series debriefing issues (sidebar). This series of articles covers Ten Elements Take your safety pulse for Safer Surgery developed by Advocate A safety culture survey provides a way to mea- Health Care, a 10-hospital system in the sure nurses’ and physicians’ responses to patient Chicago area. safety initiatives like the checklist over time, ac- Previous articles in the series focused on: cording to Safe Surgery 2015. It’s a way of taking • OR governance: January 2013 the safety culture’s pulse. The Joint Commission requires hospitals to use • Safer surgical scheduling: February 2013 valid and reliable tools for measuring the culture • Presurgical assessment: March 2013 of safety (LD.03.02.01, EP 1). One example is the • Excellence in sterile processing: April 2013. AHRQ Hospital Survey on Patient Safety Culture from the Agency for Healthcare Research and Stay vigilant Quality (www.ahrq.gov/legacy/qual/patient- safetyculture/hospsurvindex.htm). Never stop observing how teams use the checklist, the Harvard team advises. Make it safe to speak up “You can never turn your attention away. The checklist won’t be effective in protecting You have to continue to talk about it and patients if nursing staff are reluctant to speak continue to keep people excited about doing up when something seems amiss. ALG weaves it,” Edmondson suggests. Regularly observe these skills into its team training, in which 91% teams using the checklist and offer coaching of perioperative nurses and physicians have as needed, she advises. During the observa- participated. tions, ask surgical teams for feedback about the To learn whether nurses feel safe about checklist effort and what could be improved. speaking up, Mahal-van Brenk plans to survey (Safe Surgery 2015 offers an observation tool on the staff, asking them to rate on a scale of 1 to 5 its website.) how comfortable they feel bringing concerns to In Kaiser Northern California, perioperative the attention of individual physicians. She plans nurse managers audit regularly. to share the results privately with individual “If you don’t do audits and see teams using the physicians. checklist, you will get drift,” Misajet says. It’s critical for nurses to be comfortable, she Managers use a rounding tool to guide audits says, because “the last thing [physicians] want is and offer coaching on the spot if needed. If they see not to get information about a concern.” themes that need to be addressed, they bring the issue to the facility’s HRST group for discussion. Keep senior leaders involved Senior leaders not only must lend initial sup- Harness the debriefing port for the checklist but also must stay in touch Hospitals that are able to sustain the checklist with the OR on how the effort is progressing. do the sign-out (debriefing) phase of the checklist “We encourage implementation teams to give really well, Edmondson says. higher-level leadership updates on their prog- During the debriefing, in addition to confirm- ress,” Edmondson says. “We also encourage se- ing counts and specimens, the team reviews any nior leaders to go to the OR suite and talk to concerns about the patient as well as what could people who are using the checklist.” have gone better. Safe Surgery 2015 offers an observation tool These hospitals have a process for tracking the senior leaders can use. concerns, fixing them, and giving feedback to the clinicians who raised the concerns. Share stories Fixing problems gives OR teams an incentive Capturing stories about “good catches” by the to continue with the checklist and debriefings checklist that prevented harm to patients is an ef- because their lives get easier as a result. fective way to gain support. Record some of these During one debriefing, Misajet notes, a sur- stories and post them where staff and physicians geon raised concern about the state of the laparo- can see them, the Harvard team suggests. scopic surgery light cords. “Keeping track of these stories is one of the The manager enlisted the sterile processing best ways to measure the impact of the care you department, which checked the cords in all of the give in your hospital every day,” says Dr Berry. sets and repaired and replaced cords as needed. He estimates from reviewing the literature that The surgeon, skeptical that the problem had using the checklist makes a difference for about 1 been fixed, was invited to view and test cords from patient in 1,000. about a half-dozen sets and saw they all worked. “That is not a large number, but it is a life,” he “He realized the value of the debriefing,” says. That means that for 1 in every 1,000 patients Misajet notes. who comes through your doors, the checklist Nurse managers are piloting new software would make a difference between them going from Bowwave (Great Falls, Virginia) that is in- home unharmed or not leaving the hospital at all.

58 The OR Management Series Patient Safety in the OR Always seek to do better Haynes A B, Weiser T G, Berry W R, et al. A surgical safety checklist to reduce morbidity and What key feature distinguishes hospitals that mortality in a global population. N Engl J Med. have embraced the checklist from those that have 2009;360:491-499. not? When the checklist is embedded, “the first thing they tell us is, ‘We could do better,’” says Neily J, Mills P D, Young-Xu Y, et al. Association Edmondson. “They never feel they have com- between implementation of a medical team training program and surgical mortality. JAMA. pleted the project.” 2010;304:1693-1700. For them, the desire to improve is a continuing quest. ❖ Van Klei W A, Hoff R G, Van Aarnhem E E, et al. —Pat Patterson Effects of the introduction of the WHO ‘Surgical Safety Checklist’ on in-hospital mortality: A co- References hort study. Ann Surg. 2012;255:44-49. Bliss L A, Ross-Richardson C B, Sanzari L J, et al. World Health Organization. WHO surgical safety check- Thirty-day outcomes support implementation list and implementation guide. www.who.int/pa- of a surgical safety checklist. J Am Coll Surg. tientsafety/safesurgery/ss_checklist/en/index.html 2012;215:766-776. Conley D M, Singer S J, Edmondson L, et al. J Am Coll Surg. 2011;212:873-879. Emerton M, Panesar S S, Forrest K. Safer surgery: How a checklist can make orthopaedic surgery This article originally appeared in OR Manager, safer. Orthop Trauma. 2009;23:377-380. May 2013;29:1,12-15.

Patient Safety in the OR The OR Management Series 59 Implementing a daily huddle protects patients, avoids delays

Sixth in a series on ten elements of safer surgery. These are ALG’s key elements for successful huddles. ould you and your team find 30 minutes a day to prepare for the next day’s surgical Same time, same place Cschedule? The effort can be worthwhile. The huddle is held every day at the same time A Chicago-area hospital has found that a half- and place. hour daily huddle not only heads off delays and “You have to set the time aside, start on time, cancellations but also spots clinical and patient and be efficient,” Dr Young says. Huddles usu- safety issues so they don’t become obstacles the ally take 30 minutes but can take 45 minutes if the next day. The huddle team has caught near misses, patient list is complex. including surgical side and site discrepancies. They Attendance is expected and documented. The also have identified patients with unresolved clini- employed staff nearly always attend; attendance cal problems; made sure loaner sets and implants by the nonemployed personnel is at 50% to 75%, are on hand; and saved time and aggravation. Mahal-van Brenk estimates. “A lot of people have daily huddles. We’ve taken Follow a set agenda the huddle and expanded it,” says David Young, director of preanesthesia testing at Advocate Lutheran Having a standard agenda moves the meet- General (ALG) Hospital in Park Ridge, Illinois. ing along. ALG’s agenda starts by recapping the Every day at 2 pm, the huddle team meets in current day’s problems. Then the bulk of the time front of a smart board showing the upcoming is spent reviewing the schedule for the next day. cases, which average about 75 a day. ALG per- “We review the entire schedule case by case. It forms about 12,000 procedures a year in its main was slow at first, but it has gotten much faster,” OR and 6,000 in its ambulatory surgery unit. Dr Young says. Attending the huddle in addition to represen- “We are looking for any problems that might tatives from scheduling and nursing are person- occur the next day. Is there enough time allotted nel from presurgical testing, the preoperative to the cases? Is a surgeon scheduled at more than unit, sterile processing, materials management, one site? Are there pending lab results?” Deci- anesthesia, and ambulatory surgery as well as sions are made about adjusting the schedule. the surgical navigator who is the liaison with Among other issues discussed: Were loaner patients’ families. sets delivered? Are new implants being brought The huddle also serves as the first step in the in? Will the company rep be on hand? Are there patient identification process. patients with complex allergies or antibiotic needs? “We are actually saying the patient’s name and They also review issues that surfaced during double checking the procedure ordered,” notes the preanesthesia process. Cindy Mahal-van Brenk, MS, RN, CNOR, execu- “Prior to this, nurses didn’t have a forum to tive service line director for surgery. express concern about a patient they thought was high risk,” Dr Young observes. “Now they are able Community of accountability to bring this up and share it with the entire team.” A chief advantage of the huddle is that it raises In one example, the huddle resolved an issue the level of accountability, Dr Young observes. with a patient who was scheduled for a total hip “Before, everyone worked in silos.” Now, in the revision. Normally, 2 units of blood would be or- huddle, each member must acknowledge that dered. But no blood had been ordered, and the case preparations for surgery have been addressed. was scheduled for 1 1/2 hours. “If you’re the sterile processing person, and Dr Young, who led the huddle that day, you say all of the trays are here, everyone knows thought that didn’t make sense. you’ve stated that,” he says. “We got the surgeon on the phone. It really Similarly, if the anesthesia representative says was a cup change, not a total revision,” he says. a patient has been cleared, and it turns out later “So the time was appropriate and so was not that a problem wasn’t taken up with the primary having additional blood. We saved ourselves ag- care physician, “they own that,” he adds. gravation.”

60 The OR Management Series Patient Safety in the OR Safer Surgery series Teach presentation skills Nurses have learned to hone their style for This series of articles covers Ten Elements their huddle presentations, which for some for Safer Surgery developed by Advocate is a new skill, like presenting on rounds. “It Health Care, a 10-hospital system in the takes a while to learn the key elements,” says Chicago area. Dr Young. Nurses know they will be expected to know Previous articles in the series focused on: something about each patient, which he thinks • OR governance: January 2013 has helped them to organize their time better. • Safer surgical scheduling: February 2013 The huddle program at ALG has helped to • Presurgical assessment: March 2013 resolve not only scheduling issues but also a • Excellence in sterile processing: April 2013 broader range of concerns that affect safety and • Checklists: May 2013. efficiency. “The problem was how to coalesce all of the information that is floating around in everyone’s head and put it together to minimize the risk of At times, the issue is as simple as a language delays and cancellations,” Dr Young says. “The barrier. The presurgical department then arranges huddle has helped us achieve that.” ❖ for a translator to be present when the patient ar- —Pat Patterson rives, providing a source of comfort for both the patient and family. Dr Young is also a consultant with Surgical Direc- Keep leaders involved tions. www.surgicaldirections.com. Having a physician champion is essential, as it is for other patient safety initiatives. Mahal-van Brenk stays involved as well. “For the first 3 months, you need a consistent leadership presence, so people know this is seri- This article originally appeared in OR Manager, ous,” she says. She still attends periodically to reinforce that message. June 2013;29:12-13.

Patient Safety in the OR The OR Management Series 61 Lack of surgical checklist compliance suggests need to improve implementation

urgical checklist compliance among 4 Cana- Dr Papaconstantinou raised several questions: dian hospitals was around 60% in a large, • Does compliance improve outcomes, and if so, Sretrospective study of acute care operations is there a plateau? performed in 2010 and 2011. • Were clinical outcomes assessed? Although Alberta Health Services in Calgary, Alberta, Canada, had mandated checklist use • Was there a difference in the type of proce- starting in 2009, limitations such as instructional dures? For example, orthopedic surgery usually misuse, lack of perceived benefit, and lack of pro- has a higher incidence of wrong-site surgery. cedural understanding had led to misuse or non- • Are we asking our nurses to document too use of the checklist, according to Michael Laffin, much? MD, with the University of Alberta, Edmonton, Because of the large sample size and use of the Alberta, Canada. database, Dr Laffin said, his team did not look at Dr Laffin and his colleagues studied data from specific outcomes. However, he noted that the 4 hospitals in the Calgary region to assess check- literature supports use of the checklist; it is doing list use and identify predictors of noncompliance. what it’s supposed to do. The database included information on regional He also said they did not find specific differ- demographics, American Society of Anesthesiolo- ences between teams performing different types gists (ASA) class, surgical factors, admission type, of surgery. outcomes, briefings, time-outs, and debriefings. “Documentation burden on nurses is huge Their multivariable logistic regression analy- in Canada, but I think documentation of all sis showed that, of the more than 132,000 cases the operative materials is something that’s im- performed, compliance rates for the briefing, portant from a research perspective, from an time-out, and debriefing were 62%, 63%, and 62%, administrative perspective, and from a patient respectively. Dr Laffin reported their results at the care perspective,” Dr Laffin said. “It needs to 2013 American College of Surgeons Annual Clini- be a priority.” cal Congress. E. Patchen Dellinger, MD, FACS, chief of Factors associated with noncompliance in- general surgery at the University of Washing- cluded: ton in Seattle, noted that studies have shown • patient age less than 40 years that fewer complications occur when checklists • lack of general anesthetic (ie, local or regional are completed. He also referred to an Annals anesthetic use) and conscious sedation per- of Surgery study showing that administrative formed in the OR databases indicated 100% completion of the checklist, but direct observation found it was • urgent or emergent operations much less than that. • procedure duration of less than 30 minutes “As much as making sure you’re doing the • patient ASA class greater than or equal to 3 right operation on the right place, it’s the engen- • presence of an anesthetic trainee or added ab- dering of teamwork and discussion and com- sence of a surgical trainee. munication in the operating room that makes the checklist really work,” Dr Dellinger said. Checklists were less likely to be completed To help improve compliance in the future, Dr during “the 2 extremes of operative risk,” ie, Laffin suggested, researchers may look at nursing emergent or high-risk procedures as well as notes to better understand what influences noncom- shorter, lower risk procedures, and compliance pliance. They may also interview OR team members varied widely among facilities, he said. to identify perceptions and beliefs around checklist “There’s a growing body of literature that use and barriers to its implementation. ✥ shows although institutions are adopting the —Elizabeth Wood checklists, surgical teams are not,” said discussant Harry Papaconstantinou, MD, FACS, a colorectal surgeon at Scott & White Healthcare in Temple, Texas. Sixty percent compliance may sound low, he noted, but the original paper on surgical check- This article originally appeared in OR Manager, lists had a 57% compliance rate. February 2014;30:21.

62 The OR Management Series Patient Safety in the OR OR debriefings put the safety checklist ‘on steroids’

ee it, say it, fix it. That saying by a former pected. The 30-day all-cause readmission rate, FedEx pilot set the stage for a major quality 6.2%, is below the 8.0% QUEST average. Simprovement effort in surgical services at a McLeod’s core measures for 2011 averaged: South Carolina medical center. • 97.51% for on-time antibiotic administration A key QI tool is debriefings performed at the • 97.31% for antibiotic selection. end of every case. McLeod is also a low-cost provider for its mar- These quick exchanges help to bring defects to ket, having reduced its case-mix adjusted cost per the surface and get them addressed quickly. discharge by 22% for the baseline through 2010, Debriefings highlight a variety of defects from notes Donna Isgett, MSN, RN, senior vice presi- patient safety risks to minor annoyances. Payoffs dent of corporate quality and safety. from fixing them are safer care with fewer delays, with better surgeon and staff satisfaction and Resolve to ‘fix it’ labor productivity. To lay the foundation for QI in surgical The debriefings data has put the OR’s surgical services, McLeod brought in FedEx pilot Mi- safety checklist “on steroids,” says Michael Rose, chael Farnsworth, a commanding presence MD, anesthesiologist and vice president of surgi- and expert in crew resource management, now cal services at McLeod Health based in Florence, deceased. South Carolina. McLeod is one of the original One of his key points was, “See it, say it, fix designers of Premier’s QUEST High Perform- it—with an emphasis on fix it,” Dr Rose recalls. ing Hospitals program, a voluntary inpatient QI The idea is, “If you are going to ask people to project sponsored by the 2,500-member health identify risks and defects, you need to create a care alliance. time in each operation for people to be heard.” McLeod Regional Hospital, the system’s 450- Then you need to fix it. bed flagship, has a surgical volume of about OR leaders seized on the World Health Or- 19,000 cases a year. ganization Surgical Safety Checklist as a tool not QI from the top only to make care safer but also to improve operational performance. QI at McLeod is led from the top. Senior ex- A group from surgical services, including ecutives gather each morning to review quality medical staff, anesthesia providers, nurses, and metrics on a whiteboard. Were there any codes technicians, decided they needed to create an in the past 24 hours? How are patient experi- opportunity for any team member to tell manage- ence scores? What new best practices are being ment what it needed to focus on. introduced? Management “committed to them we were Since joining the Premier program 3 years going to come back and do it,” says Dr Rose. ago, McLeod’s mortality index improved from The group decided that the WHO checklist, 1.02 to 0.799 for 2011, compared to 0.6 to 0.7 for including the debriefing, would be completed for peer hospitals, with 19 fewer deaths than ex- every case. The checklist, launched in 2008, identifies safety measures to check during 3 phases of The debriefing the operation: • before anesthesia induction (brief) In the debriefing, called the “Sign-out” in the WHO checklist, the nurse verbally • before the skin incision (time-out) confirms with the team: • before the patient leaves the OR (debrief). • the name of the procedure recorded Studies have found use of the checklist signifi- • that the counts are correct cantly reduces surgical morbidity and mortality. • specimen labeling Though many ORs have embraced checklists, • any equipment concerns. debriefings have been slower to catch on than the Then the surgeon, anesthesia profes- briefing and time-out. In the 2011 OR Manager Salary/Career Survey, only 37% of respondents sional, and nurse review key concerns for were using debriefings, whereas 55% of respon- the patient’s recovery and management. dents had implemented briefings.

Patient Safety in the OR The OR Management Series 63 Debriefings a focus The nurse then asks if there were any is- At McLeod, the debriefings have become a focus. sues that could have made the case go better Some 2,000 debriefings have been analyzed and the and then completes a paper debriefing form data used to set priorities for improvement. (illustration). In lieu of detailed comments, the Debriefings “allow us to see where there are nurse might simply write, “See me,” or “Call risks, vulnerabilities, and system defects,” says me about this.” Dr Rose. Howell collects the forms and compiles As fixes were made, surgeon satisfaction rose the information daily in an Excel spreadsheet, because they saw their cases being completed which is sent to the management team and a with fewer delays. few others. “We have learned that this kind of communi- “We know within 24 hours if there has been a cation dramatically alters the day for surgeons,” problem with a case,” she says. If necessary, she he says. can go back to the staff member in the room and The OR’s labor productivity is also up. Labor ask about the situation. has been reduced by 3 to 4 minutes per case on Examples are a wrong patient sticker on a chart, average as delays have decreased, says April a wrong consent filled out, or a supply not avail- Howell, RN, CNOR, assistant director of surgi- able. An attempt is made to address each defect. cal services. ‘People are listening’ “If you have 4 to 6 people in a case, and there The benefit of tracking and fixing defects, she is a 15-minute delay, that is a lot of time. The con- says, is that the surgeons and staff realize “people nection between the debriefing information and are listening.” operational effectiveness has been very direct.” Since data collection on debriefings began in How debriefings are conducted November 2010, the percent of cases with defects The debriefing is performed at the end of each has declined from 17.5% to about 8%. case as the surgeon closes the incision. The circu- “What I hear from staff is that we’re identi- lating nurse asks the team for information such as: fying problems and fixing them so they’re not repeating as much,” Howell says. • where the patient is going from the OR Compiling the debriefings takes about 1 hour a • the patient’s specific needs day, she estimates. • blood loss “It’s a little time-consuming. But we’ve seen a • review of specimens and labeling. huge return on investment both in patient safety and staff and surgeon satisfaction.”

64 The OR Management Series Patient Safety in the OR Learning from a fall Safety and quality structure From one debriefing, the management team McLeod has reached out to learn about perfor- learned what went wrong in a case where a mance improvement, Dr Rose notes. patient fell from an OR table. Fortunately, the Every employee and a number of physicians patient was not significantly injured. have received PI training, working with a team A team member had raised concern about the led by Atul Gawande, MD, and his group from patient’s positioning, but others had brushed off Harvard as part of the South Carolina Hospital the concern. Association’s Safe Surgery 2015 initiative (www. Instead of being hushed up, the incident was safesurgery.org). The initiative’s goal is for the shared and discussed with the staff. WHO checklist to be used in every OR in the state “We took a look at all of our positioning, by the end of 2013. brought in educators, and got different tools for McLeod’s managers and a group of physicians our staff,” Howell says. were also part of a distance learning group led They also discussed the need for each team by Marshall Ganz, PhD, of Harvard, an expert on member to have a voice and to listen to others. community organizing and organizational behavior. Catching a near miss “We learned a lot about the theory and method A wrong-site surgery averted got the attention of interacting with people,” says Dr Rose. of a surgeon who had not fully bought in to brief- One lesson was the benefit of interacting peer ings and debriefings. A laterality discrepancy was to peer when introducing a change such as the caught during the briefing. checklist, particularly for the physicians. From then on, says Howell, he had buy-in. “Our strongest physician users are now using the Other near misses identified have been patients peer-to-peer connection to take the idea to each of with allergies and patients who are Jehovah’s their peers,” he says, adding, “It’s painstaking work Witnesses and won’t accept blood transfusions. over a long time.” Events where harm actually reached the patient or got close “have fallen dramatically,” Dr Sustainability Rose says. To sustain the effort, the management team In a complex system like an OR, “it’s not neces- audits briefings, time-outs, and debriefings, giv- sarily possible to get defect rates to zero,” he says. ing immediate feedback to the teams. “But the team’s capability through collaboration Support comes from the top, Dr Rose observes, can substantially mitigate the actual harm that with senior execs and board members regularly results when something has gone awry. We think coming to the OR. we’re seeing that in our data.” The chairman of the board, a realtor, visits the OR, dresses in scrubs, and talks with team members. Staff voice support Isgett says McLeod’s participation in the Pre- McLeod’s staff voiced their support for brief- mier QUEST project creates “constant movement” ings and debriefings in a 2011 safety culture to improve. Hospitals pledge to be transparent in survey. sharing data and best practices. One staff member responded: “I strongly In turn, she says, “We feed that back into other believe the checklist encourages conversation QUEST hospitals. That is the secret to the work— among members of the staff. It helps the team flowing it through.” ❖ discuss every aspect of the patient’s condition and —Pat Patterson focus on the critical abnormal points. “The surgical arena can be both a stressful and demanding area to work [in], but with effectively implementing the checklist, the process has For more about the WHO Surgical Safety Checklist, visit slowed enough for us to focus on the important www.who.int/patientsafety/safesurgery/en/index.html point, the patient.” The survey was conducted by the Harvard This article originally appeared in OR Manager, School of Public Health and the South Carolina November 2012;28:20-22. Hospital Association.

Patient Safety in the OR The OR Management Series 65 Preoperative practices overhauled after surgical checklist failure

se of the World Health Organization’s sur- • The surgeon was not present when the plexus gical safety checklist has reduced surgical anesthesia was induced. Ucomplications and mortality, but a narrow • The right side was indicated in the electronic escape after a checklist failure at an Italian hospi- memo of the operation created by the surgeon tal suggests that more vigilant efforts are needed during the patient’s first visit but was not to avoid errors. printed in the medical record. In August 2012, an 81-year-old patient with • There was a lack of communication among all vascular dementia was brought to the OR at G. surgical team members and the patient. Fracastoro Hospital, San Bonifacio (Verona), Italy, for left carotid artery surgery, as indicated on the Role of checklists sign-in sheet when his surgery was scheduled. Checklists are used in the surgical units and In the preoperative area, the anesthetist ORs of many hospitals in Italy, although the coun- obtained the patient’s consent, confirmed the try in general has been slower to adopt their use surgical site, and asked a colleague to perform than have US hospitals. In 2009, the Italian Na- an ultrasound-guided cervical plexus block of tional Health Service published OR Safety Recom- the left carotid artery because he was not skilled mendations that included a surgical checklist, but in this technique. The surgeon was absent from that checklist was used largely on an experimen- the preoperative area while the anesthesia was tal basis. In 2012, checklists were put into place in being given. the surgical departments of all Italian hospitals. During the time-out prior to surgery, however, Nonetheless, the carotid case demonstrates that the surgeon realized that surgery should be per- even with the use of checklists, there’s still a dan- formed on the right carotid artery, not the left. ger of wrong-site surgery. The patient was given general anesthesia, and The carotid case was the first time that the the procedure was performed on the right carotid checklist had failed in that particular OR, but it artery. Afterward, the patient was admitted to the clearly demonstrates poor communication and ICU for postoperative monitoring for 24 hours. lack of nontechnical skills among the OR team. How errors creep in These skills are well developed in civil and The incident is an example of the “Swiss military aviation environments but are less com- cheese” model of failure, in which slices of cheese mon in health care organizations. All surgeons, represent barriers against organizational failure anesthetists, and nurses should have strong situ- and the holes in the cheese slices indicate weak- ational awareness, decision making, communica- nesses in individual parts of the system. The sys- tion, leadership, and teamwork skills. tem as a whole fails when the holes in each slice In conjunction with nontechnical skills, check- momentarily align, allowing an error to creep into lists are designed to promote interdisciplinary the defenses designed to protect against failure. communication and to provide a framework for In the carotid case, the holes were as follows: the many perioperative steps involved in patient care. To augment these skills at G. Fracastoro • The side was listed incorrectly on the initial Hospital, interdisciplinary teams composed of scheduling sheet. surgeons, anesthetists, and nurses participated • The nurse on the patient unit indicated the in a project at the hospital led by civil aviation wrong side (perpetuating the error from the pilots who had had crew resource management scheduled list instead of double-checking with training. the surgeon, as should be done in unclear or As part of this project, an OR checklist pro- ambiguous cases). totype tailored to different specialties (general, • The front page of the medical record stated “right pediatric, obstetric and gynecological, vascular, occlusion, left stenosis,” which was unclear. urologic, and orthopedic surgery) was developed • Two anesthetists were involved in the proce- to improve communication and to better manage dure. potentially critical situations, decision making, and situational awareness. • The patient’s dementia prevented him from Each specialty checklist was used in different recognizing the error. simulated scenarios, followed by debriefings with

66 The OR Management Series Patient Safety in the OR the entire team. Communication has improved References with the use of these checklists, and the OR man- de Vries E N, Prins H A, Crolla R, et al. Effect of a ager continues to monitor their use to avoid com- comprehensive surgical safety system on patient munication breakdowns. outcomes. N Engl J Med. 2010;363:1928-1937. As a result of the carotid incident, a clinical Haynes A B, Weiser T G, Berry W R, et al. A audit was conducted with input from all mem- surgical safety checklist to reduce morbidity bers of the surgical team. A new procedure for and mortality in a global population. N Engl J filling out the surgical checklist was produced Med. 2009;360:491-499. and approved. As part of this, the patient’s mental status is Pronovost P J, Bo-Linn G W. Preventing pa- assessed on the basis of medical history and, if tient harms through systems of care. JAMA. 2012;308:769-770. necessary, consultation with a neurologist. The sign-in process was rewritten and now involves Reason J. Human error: models and management. the entire surgical team whenever any aspect of BMJ. 2000;320:768-770. a case is unclear, and the electronic memo is now Stahel P F, Sabel A L, Victoroff M S, et al. Wrong- included in the official documentation for every site and wrong-patient procedures in the uni- ❖ surgical patient. versal protocol era—analysis of a prospective database of physician self-reported occurrences. — P Sette, MD, is OR manager at G. Fracastoro Arch Surg. 2010;145:978-984. Hospital in San Bonifacio (Verona), Italy. Pronovost P J, Hudson D W. Improving healthcare quality through organizational peer-to-peer —R M Dorizzi, MD, is with Corelab, Laboratorio assessment: lessons from the nuclear power Unico di AvR, in Pievesestina di Cesena, Italy. industry. BMJ Qual Saf. 2012. doi:10.1136/bmjqs- 2011-000470. —A M Azzini, MD, is with the Department of This article originally appeared in OR Manager, Pathology, Infectious Diseases Unit, at Azienda Universitaria Ospedaliera Integrata, Verona, Italy. August 2013;29:26-27.

Patient Safety in the OR The OR Management Series 67 Team participation and planning produce quality handoffs

fter a poor handoff from the OR to the the study’s authors. Having an awareness and a postanesthesia care unit (PACU) was structure to the handoff “shows we think it’s a Aidentified as the culprit behind a serious really important part of patient care,” he says. adverse event, Nancy Robinson, DNP, MSN, For example, when the anesthesiologist tells the RN, LHRM, CCM, made it her mission to avoid nurse and the respiratory therapist where the a recurrence. endotracheal tube is taped, both clinicians will “I’m passionate about safe patient hand-offs,” know to speak up if they note even a small dif- says Robinson. “I didn’t want this to happen to ference in placement. another patient.” Dr Twite attributes the reduction in ventilator Robinson, who is director of education at time to setting expectations. “That helps the ICU Health Central Hospital, Ocoee, Florida, part of team decide on who to fast-track for extubation, the Orlando Health System, tackled the project of and the anesthesiologist, surgeon, and nurse are improving handoffs as her doctorate in nursing all on board with the plan. Everyone is hearing capstone project, working closely with Marcia the same message.” Olieman, MBA, RN, director of surgical services. The result was a tool that has boosted OR and Assemble the right team PACU nurse satisfaction and is still being used 2 Like professional coaches, OR leaders must years later. strive to build the best team possible to attain In 2006, the Joint Commission launched a success. “It’s hard to get everyone to come to the National Patient Safety Goal for implementing table,” Olieman acknowledges. standardized handoffs, and in 2013, the Com- At Health Central Hospital, a community hos- mission’s Center for Transforming Health- pital that has 8 ORs and performs nearly 5,000 care released Improving Transitions of Care: procedures a year, she and Robinson surmounted Handoff Communications. The tool is based on that challenge by drafting champions from each the acronym SHARE: Standardize critical content, area affected by handoffs to be on the team. The Hardwire within your system, Allow opportunity chief of anesthesia and a certified registered nurse to ask questions, Reinforce quality and measure- assistant known for his strong patient advocacy, ment, and Educate and coach. along with representatives from the PACU and Many hospitals are using these principles when the OR, comprised the team. These leaders were they address how to conduct a handoff, which able to help “bring reluctant ones into the fold,” seems to be a simple task. But like a young person says Olieman. The interdisciplinary team also in whom a surgeon unexpectedly finds cancer, managed to break down silos, getting staff from appearances can be deceiving. Handoffs aren’t various departments to talk more about issues simple. An effective handoff requires commitment, beyond handoffs. coordination, and yes, a bit of passion. Ina Cherepaha-Kantorovich, MN, RN (EC), advanced practice clinical educator for the pread- The value of handoffs mission, PACU, endoscopy, and cystoscopy units OR leaders, clinicians, and other administra- at Toronto General Hospital in Ontario, Canada, tors intuitively know that accurate handoffs help suggests asking for volunteers to fill staff spots prevent errors that can harm patients. But hand- on the team. The working group for handoffs offs can also improve outcomes. A study of 1,507 facilitated by Cherepaha-Kantorovich and Maria neonates, infants, children, and adults published Masella, MN, RN, educator in the OR, included 4 in the Joint Commission Journal on Quality and staff nurses from the OR and 4 from PACU. Patient Safety found that using a structured hand- “You also have to have organized meetings off when transferring patients from the cardiovas- and follow-up during implementation so the cular OR to the cardiac ICU significantly reduced process doesn’t fall apart,” she adds. “Include the number of unplanned extubations and the staff all the way.” Cherepaha-Kantorovich and amount of time patients were on the ventilator. Amanda Zakrzewski, a PACU staff nurse, spear- “The handoff protocol definitely contributed headed the process. to those results,” says Mark Twite, MD, BCh, Think outside the box; a nonclinical person can MB, an anesthesiologist at The Heart Institute of be a great facilitator, says Mary Grzybinski, BSN, Children’s Hospital Colorado in Aurora and 1 of RN, administrative clinical advisor for PACU at 68 The OR Management Series Patient Safety in the OR Beth Israel Deaconess Medical Center (BIDMC) post-transport communication, disposition of the in Boston. A staff member from the business patient, and communication interoperatively to transformational office who is embedded in the the unit that will receive the patient after surgery perioperative area helped the 10-member multi- (sidebar). Strategies were identified to address disciplinary BIDMC team establish an effective each area. handoff procedure. Robinson says a factor that’s easily missed in “We are focused on clinical, so we don’t an analysis is whether people are focused on the always see how to attack a problem from a big- handoff or on the task. When observing hand- ger picture,” Grzybinski says. The business staff offs from the OR to the PACU, she was struck member “helped us see the business end and keep by the fact that participants were doing many us focused.” tasks while trying to receive important patient information. Analyze the process “When you are performing tasks and receiv- Many OR leaders use Lean tools to analyze the ing information simultaneously, you don’t retain handoff process. A value stream analysis showed what you are being told,” she says. That led to the the team at Health Central Hospital deficiencies creation of a “no fly” zone—report is not given in the current process, Robinson says. The team until basic tasks, such as connecting the patient at BIDMC also performed a value stream analysis to the monitor and oxygen, are completed, so the and identified several categories of changes that PACU nurse can give the other clinicians his or could be made. her full attention. “The value stream map helped us know how Another vital part of the analysis is examin- everyone perceived handoffs so we were on the ing attitudes. “The biggest challenge for making same page,” Grzybinski says. Team members the change wasn’t the surgeons, it was the OR learned what others needed from them. nurses,” Cherepaha-Kantorovich says. “PACU nurses sometimes only got part of a In fact, OR nurses didn’t like the initial tool, patient’s information because the provider didn’t saying it didn’t reflect what they did. A survey realize that the whole picture made a difference revealed OR nurses felt “devalued” because the in the case,” she says. “Then we did an impact PACU staff weren’t paying attention to what difficulty analysis grid that helped us analyze the the OR nurses were saying. The PACU nurses difficulty of fixing each problem and the impact revamped their approach, and the process was fixing that problem would have on improvement revised so that it better reflected contributions in handoffs. Communication had the highest dif- from the OR nurses. ficulty and the highest impact, so we decided to tackle that.” Put the process in place The team created an affinity diagram that ex- Protocols, especially those incorporating amined 4 areas: communication before transport, checklists, are a frequent—and effective—solu-

Handoffs Team Affinity Diagram

Communication Prior to Transport (Transition) Disposition of Pt •AUDIT>>>Members •AUDIT>>>Receiving • Communication • This decision should include nurse notifies RT if pt. w/entire should be done as accepting nurse, NP, needs a ventilator procedure room early as possible Handoff PA , or resident, fellow team. (Timing is • Someone must • Have someone or RT, if needed a factor) OWN Miniscripts from Surgery • AUDIT>>>Standardize communicating present for •MINISCRIPT>>>Formal list of criteria for PACU • Difficult to the decision to the handoff notification to receiving resident notification determine until Admissions team members the last minute Facilitator • AUDIT>>>Transport to • Standardize the •AUDIT>>>Verify destination with handoff content & presence of RT appropriate monitors Communication personnel Interoperative Post-Transport OR to Receiving Key Communication Red = problems • Get notified • Make as Green = Opportunities for of equipment, default that OR • If the sequence of these 3 Improvement • Anesthesia and nurse calls steps (1. Anesthesia ensures drips, lines NP = nurse practitioner receiving nurse receiving unit close loop on pt.’s vital sign are stable, 2. Miniscripts PA = physician assistant stability of p.t Anesthesia prints report & 3. • Develop a RT = respiratory therapist before printing Anesthesia resident gives preparatory • Standardize when notification report handoff to receiving nursing) is report that is not followed there could be relevant to pt occurs adverse outcomes disposition

The affinity diagram shows communication problems and opportunities in each of 4 key handoff areas. Clinicians can use miniscripts to ensure they provide needed information. Source: Beth Israel Deaconess Medical Center, Boston. Used with permission.

Patient Safety in the OR The OR Management Series 69 Handoff Communication Guidelines PERIOPERATIVE PEARLS Patient name: ______Age: ______Allergies:______Procedure performed______Primary language spoken: □ English □ other: ______Past medical history: □ Diabetes □ HTN □ COPD □ Asthma □ OSA □ Renal Disease □ Seizures □ Cardiac □ CAD □ PVD □ CVA □ Liver Disease □ETOH P □ Smoking (ppd____) □ Arthritis □ MRSA □ VRE □ TB □ C Diff □ Deaf □ HOH □ Blind Position during surgery: □ supine □ prone □lithotomy (type of stirrups: □ candy cane □ allen) □ jack knife □ Other ______Precautions: □ falls □ Seizure □ Aspiration □ Decubitus □ Isolation: □ Contact □ Droplet Personal Items: □Dentures □ Glasses □ Hearing Aids □ Prosthesis :( ______) Pain management: □ PCA pump □ Epidural □ On-Q pump □ Other:______

Extremities: □ Ted hose □ SCD’s □ Pulses Adverse events intraoperative: ______E Equipment needs: □ CPM □ Ventilator □ Wound Vac □ NGT □ Cell saver Elimination: □ Foley □ Suprapubic tube □ I&O □ Straight cath

Assessment: □ Skin □ Incision □ Packing □ Musculoskeletal □ Neuro Drains: □ JP □ Hemovac: location______□ Penrose □ Blake tube □ Chest tubes: □ Rt □ Lt □ Urology stents: □ Rt □ Lt □ G tube A Dressings: Location ______Number___ Drainage: □ Yes: Type ______□ No Antibiotic: □ Yes: Time last dose______□ No Vital Signs: Temp: ______HR ______BP______RR______

Relationships: Family location: ______Contact phone #:______R Radiology: □ CXR □ Other

Labs due: □ H&H □ BMP □ CBC □ PT/PTT □ T&C □ Accuchek □ Blood sugar □ ABG □ Critical values: ______Lines: □ Central □ Arterial □ Peripheral: location:______L □ Swan-Ganz □ CVP □ PICC line □ Port: location:______Blood products: ______

Special devices: □ Pacemaker □AICD □ Insulin pump □ Other ______Special needs: □ DVT protocol □ Specialty bed:______Spiritual needs: ______S Special communication needs: □ Sign language interpreter □ Interpreter Surgical Unit: □ SCU □ OSU □ CVICU □ PCU □ IMCU □ MSU □ TMU This worksheet, which facilitates handoffs, is not part of the medical record. Source: Health Central Hospital, Ocoee, Florida. Used with permission.

tion to handoff challenges. For instance, a 2013 “Although some people might think it’s double study in Pediatric Anesthesia found that a check- documenting (because some of the information on list dramatically improved the quality and reli- the tool has to be entered into the computer), it’s ability of the handoff. not,” Olieman notes. “It’s not hard and it’s not Olieman recommends allowing protocols to complicated. It’s like a worksheet.” develop organically. “We kept the flow of infor- The tool has expanded so that it starts in the mation during the handoff loose at first so that it preoperative area and travels with the patient could be developed, and then we standardized so through the OR, the PACU, and onto the nurs- it included what each person needed to know,” ing unit. Olieman says. “It’s color coded, so each unit has ownership Ultimately, the team developed a paper tool for their section,” says Robinson, who adds, (sidebar). Olieman says the paper format is key to “It’s not just a piece of paper; it’s a process the tool’s success: “When a nurse gets a patient, by how we can make the patient’s trajectory she needs to know information really fast without through the system safe and meet regulatory flipping through a dozen computer screens.” The agency requirements.” tool, which isn’t part of the permanent patient BIDMC’s guidelines “spell out what happens record, provides that. from step to step, whether the patient is going to

70 The OR Management Series Patient Safety in the OR Sample narrative script This is an example of the narrative scripts used at Beth Israel Deaconess Medical Center, Boston, to remind providers what information to provide. Among the other scripts are 1 for the anesthesia provider to the RN circulator and 1 for the anesthesia provider to the RN receiving the patient after surgery.

Narrative script: RN circulator to receiving unit Sender (RN Circulator) Hi, We are finished in room ____, Dr ______patient______, who had a ______procedure. He/she will need the following: • Ventilator or specific respiratory set up (eg, t-piece) • Drips and patients weight • Invasive monitoring set up • Precaution status • Epidural Receiver (Receiving RN) Thank you OR I need clarification of the following… Sender (RN Circulator) Can we have a slot/room? Receiver (Receiving RN) Thanks for the information. You can go into slot/room ______OR we will call you back with a slot/room. Source: Beth Israel Deaconess Medical Center, Boston. Used with permission.

the PACU or the ICU,” says Grzybinski, adding The time factor that scripts help everyone remember what needs Rapid throughput is essential for a successful to be included (sidebar). “Otherwise, people OR, so staff and leaders worry about the time tend to tell what they think is important, which spent on handoffs. Fortunately, this fear is often might not be what’s important to the other unfounded. “There was some reluctance [among] person,” she says, citing situations in which OR nurses to participate,” says Robinson. “They the anesthesiologist fails to mention the patient were eager to get back to the OR to start the next doesn’t speak English or can’t hear at all without case.” By eliminating the inefficiencies discov- his hearing aids. ered through the value stream analysis, however, “We try to broaden the horizons of all provid- nurses easily found the time they needed. ers,” Grzybinski says. “It’s not just what one pro- “Taking time up front can save time later on,” vider needs; it’s what we all need to take excellent Cherepaha-Kantorovich adds. The handoff takes care of the patient.” Laminated cards of the scripts about 5 minutes and replaces the multiple calls are available. PACU staff used to have to make to the OR to The structured handoff used at Children’s obtain missing information. Hospital Colorado outlines the order of report. And, of course, time isn’t standing still in the After the patient is on the ICU monitor and the OR while the nurse is in the PACU or ICU. “While vital signs have been checked, the OR nurse and we are doing the handoff, our team is doing the ICU nurse both verify the patient’s identification. room turnover,” says Dr Twite. He says the entire The cardiac surgeon or fellow gives report, fol- team agrees that any delay “is a small price to pay lowed by the anesthesiologist or anesthesia fellow for accurate handover of patient information. An and the OR nurse. accurate handover is part of excellent patient care Dr Twite says the team in the cardiovascular and excellent outcomes.” ICU then does a “wrap up, going through the Follow up plan for the patient—hemodynamic goals, where we are going with extubation, the plan for seda- To ensure the handoff process meets the team’s tion—and at the end they cover any questions or needs, it’s helpful to survey clinicians at key concerns. Then the ICU assumes official care of intervals. Robinson used a Likert scale to assess the patient.” satisfaction among OR and PACU nurses before Whatever the process, Cherepaha-Kantoro- and after implementation. After implementation, vich emphasizes that consistency is vital even satisfaction increased in both areas, with a par- if that means standing firm. “If a surgeon or ticularly dramatic increase among OR nurses. OR nurse didn’t come, the PACU nurse didn’t “[The handoff process] helped them put aside the accept the patient,” she says. “You need the task part of the job and remind them why they consistency so that people understand it is seri- became perioperative nurses,” Olieman says in ous; it’s important for the patient’s safety.” She accounting for the increase. and the OR nurse educator made sure they were Cherepaha-Kantorovich surveyed staff before available to staff to facilitate implementation, and after implementation and 1 year later. “The and now the process is standard practice. final evaluation was very positive,” she says, add-

Patient Safety in the OR The OR Management Series 71 ing that the new process has now been in place Cynthia Saver, a freelance writer, is president, for 18 months. Most surgeons and PACU, OR, CLS Development, Inc, Columbia, Maryland. and anesthesia staff believed the handoff tool had References improved communication and helped to convey accurate patient information to the PACU staff. Boat A C, Spaeth J P. Handoff checklists improve the reliability of patient handoffs in the operat- A commitment ing room and postanesthesia care unit. Pediatr to patient safety Anesth. 2013;23(7):647-654. “Anytime there is a change, it’s hard,” Rob- Kaufmann J, Twite M, Barrett C, et al. A handoff pro- inson says. “But this [handoff tool] has become tocol from the cardiovascular operating room to hardwired into the process.” Olieman says the cardiac ICU is associated with improvements in tool is part of orientation and that the periop- care beyond the immediate postoperative period. erative nursing council has taken ownership of Jt Comm J Qual Patient Saf. 2013;39(7):306-311. it. Perhaps the most exciting payoff for the team The Joint Commission Center for Transforming at Health Central Hospital was that in 2012 they Healthcare. Improving transitions of care: Hand- received an award from the Florida Hospital off communications. May 13, 2013. http:// Association. www.centerfortransforminghealthcare.org/ So what advice does Olieman have for other assets/4/6/CTH_Hand-off_commun_set_ OR nurse leaders planning to work on handoffs? final_2010.pdf “Don’t be afraid to take on the big, scary project. It was overwhelming, but we did it.” ✥ This article originally appeared in OR Manager, —Cynthia Saver, MS, RN March 2014;30:1, 10-13.

72 The OR Management Series Patient Safety in the OR Team training, checklist equal better outcomes in pilot

eam members simply introducing them- baseline patient safety culture in the OR. The SAQ selves to one another at the start of a case is a validated survey developed at the University Tmade a difference in the rate of infectious of Texas. events in a pilot study. The rate was 1.9% when the introductions were documented and 21.1% Team training when they were not. (The infectious event rate The SAQ responses were used in forming the included surgical site infections, urinary tract communication team-training sessions. The study infections, and pneumonia.) team analyzed the SAQ answers, and Nancy Kraf- Overall, in the study at Saint Francis Hospital cik-Rousseau, PhD, a communication specialist at and Medical Center, Hartford, Connecticut, team Saint Francis, used them to form the communica- training plus use of a surgical safety checklist tion team training sessions. reduced adverse events from 24% in control pa- These 3 hour-long sessions included topics tients to 16% in cases with team training only and such as differences between introverts and ex- to 8% in cases with checklists plus team training. troverts, effective dialogue among OR personnel, The authors say this is the first study to ex- and how to use a checklist. Sessions were offered amine how team training can help teams using a on all shifts, including weekends. checklist with validation through the American Introducing the checklist College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database. The checklist was introduced in didactic ses- A report of the study, which used the AORN sions “because we wanted to build upon the im- Comprehensive Surgical Checklist, is in the Jour- portance of each specific measurement and part nal of the American College of Surgeons. of that checklist,” says Ross-Richardson. Staff also brought up their concerns. Study groups Dr Ellner was a key to checklist implementa- Data on patients from the NSQIP database was tion, she says, because the staff considered him a used as controls and compared with: role model. • a group of 246 procedures performed by teams “You have to have a champion working who had communications training on the front lines every day. He is passionate about dealing with conflict and making sure • a group of 73 procedures performed by teams the patient is safe. Without him, I don’t think who had communications training and used the project would have been as successful,” a checklist. Both physicians and staff received she says. the training. The check-in phase of the AORN checklist is Complications included surgical site infections initiated in the preoperative area. The remaining 3 (SSIs), venous thrombosis, pulmonary embolus, phases are completed in the OR. The checklist, on and urinary tract infections. a laminated card, starts with the time-out, which The pilot study stemmed from a fellowship is initiated and led by the anesthesia provider. project by Scott Ellner, DO, MPH, FACS, a general trauma surgeon and vice chairman of surgery at Study observers Saint Francis and a fellow with the American Hos- During the study cases, trained observers as- pital Association and the National Patient Safety sessed whether the checklist was used, tracked Foundation. the number of times the circulating nurse exited After IRB approval was granted, the group during the case, and documented any safety-com- held a kickoff in September 2010 to explain the promising events. project to those involved, including periopera- Three medical students, including Lindsay tive nurses, surgeons, anesthesiologists, certified Bliss, MD, who had a strong interest in quality registered nurse anesthetists (CRNAs), surgical and safety, were trained to be observers. technologists, and nursing assistants, notes Cyn- “Dr Bliss was passionate about the project and thia Ross-Richardson, MS, BSN, RN, CNOR, the went well above and beyond what we were ex- NSQIP coordinator at Saint Francis. pecting,” notes Ross-Richardson. At the meeting, the group completed a safety “An observer would bring the checklist to attitudes questionnaire (SAQ) to determine the the nurse in the preoperative area and follow

Patient Safety in the OR The OR Management Series 73 the patient and checklist throughout the preop, Why would introductions make a difference? intraop, and postoperative periods to sign-off in One theory, she says, is that introductions in- the PACU. still a sense of accountability and help to ensure “We had a lot of commitment from them,” she that everyone’s voice can be heard. adds. “One case lasted 9 hours, and the observer Using a checklist also had an effect on OR was there for all of it.” time. Without a checklist, cases lasted an average of 155 minutes; with a checklist, that dropped to Safety events 145 minutes. Events were grouped according to the na- “It all relates to discerning the plan of care— ture of the deficiency, such as communication, knowing ahead of time what’s needed, checking equipment availability or malfunction, disrup- the equipment, and making sure it works,” San- tive behavior, patient flow and process, and zari reiterates. sterility. Observations were tallied and analyzed, and Team training is key the data was matched with the NSQIP data. “Conducting this study has opened the door Though 150 cases with checklist use were for others to realize there are ways to improve necessary to maximize the likelihood of sta- patient care in a simple, not very costly way,” tistical significance, the sample size was 73 says Ross-Richardson. The tools are available, and because of limited availability of trained ob- most are free—the key is team training. servers. If a hospital has instructors who can provide Still, the numbers collected did demonstrate team training, it can design a program using the some statistical significance, says Laura Sanzari, SAQ. The SAQ provides a baseline measure of BSN, RN, APACHE outcomes coordinator for clinicians’ concerns. Team training can address Saint Francis. those concerns, starting an OR on the path to safer surgery. Checklist and outcomes Saint Francis is continuing the team training Three components of the checklist were linked when new issues arise and when new staff come to significant changes in morbidity, though other on board. events also showed a decrease. There were more The researchers say they will use the data to deep SSIs when: support universal adoption of the checklist at • confirmation of patient identity was lacking their medical center. They also plan to pursue a • there was a failure to address the procedure multicenter study to increase the statistical power ❖ and procedure site during the check-in section of their research. of the checklist. —Judith M. Mathias, MA, RN Also, cases where it was not documented that References the team members had introduced themselves to AORN Comprehensive Surgical Checklist www. one another were more likely to have infectious aorn.org/Clinical_Practice/ToolKits/Correct_ events than those where the introduction was Site_Surgery_Tool_Kit/Comprehensive_check- documented (21.1% vs 1.9%). list.aspx#axzz2IpccM7bN The fewer times the circulating nurse exited, the lower the morbidity rate. Exits varied from 0 Bliss L A, Ross-Richardson C B, Sanzari L J, et al. to 25 per case. Thirty-day outcomes support implementation of a surgical safety checklist. J Am Coll Surg. What accounts for the results? 2012;215:766-776. Sanzari says she thinks the findings relate to Dunn E, Mills P, Neily J, et al. Medical team train- the plan of care and disseminating the plan to the ing: applying crew resource management in the team prior to the procedure. The plan of care was Veterans Health Administration. Jt Comm J Qual part of team training. Patient Saf. 2007;33:317-325. “Having the plan of care, which includes the Safety Attitudes and Safety Climate Questionnaire. procedure, name, site, supplies, and equipment, https://med.uth.edu/chqs/surveys/safety-atti- affects the number of times the circulating nurse tudes-and-safety-climate-questionnaire/ leaves the room,” she says. “Traffic in and out of a room causes air disturbances, which could lead This article originally appeared in OR Manager, to surgical site infections.” April 2013;29:16-17.

74 The OR Management Series Patient Safety in the OR III. High Reliability

Patient Safety in the OR The OR Management Series 75 Rounding tool off to a good start in improving patient satisfaction

mobile, web-based rounding tool is al- since the beginning of 2012 as a test site for develop- lowing the perioperative leadership team ing the tool for use in their high reliability training. Aat Vail Valley Medical Center (VVMC) in Safer Healthcare (Littleton, Colorado) is a Vail, Colorado, to collect, analyze, and report on training, consulting, and healthcare products firm information gathered from surgeons, staff, and that focuses on establishing a patient safety cul- patients to improve quality of care and move to- ture through creating high reliability healthcare ward high reliability. organizations. “Rounding to influence” is 1 ele- Software designed by MyRounding Solutions in ment of an evidence-based bundle of leadership Littleton, Colorado, was customized to VVMC and methods used in highly reliable organizations. downloaded into an iPad (www.myrounding.com). Structured and consistent rounding also has Icons and simple navigation menus make rounding, been found to increase patient satisfaction and data gathering, and tracking of trends simple. improve HCAHPS (Hospital Consumer As- “MyRounding is so great because it is so porta- sessment of Healthcare Providers and Systems) ble, and the software is very easy to use and navi- scores. MyRounding uses HCAHPS best practices gate through, whether you are computer literate and patient-centered scripts. or not,” notes Mary Jo Steiert, BSN, RN, CNOR, Everyone on the VVMC perioperative leader- director of perioperative services at VVMC. ship team has their own iPad with the MyRound- VVMC is a community hospital with 4 rooms in ing software, including Steiert, the perioperative its main OR, 4 rooms in its adjoining surgery cen- educator, perioperative nurse liaisons, specialty ter, and 4 rooms in its surgery center in Edwards, team leaders, and charge nurses in the OR, preop- Colorado, which is 4 miles from Vail. VVMC also erative area, and postanesthesia care unit. includes the Steadman Clinic, a world-renowned orthopedic clinic, and the Steadman Philippon Leadership rounding questions Research Institute, where 9 orthopedic fellows a For her leadership rounding, Steiert has a set year develop their surgical skills. of questions in the iPad for the surgeons and a set Though perioperative services just began using for the staff, with icons for each (sidebar above). the VVMC-specific MyRounding in November “We created a series of questions for surgeons and 2013, the hospital has been working with Safer staff, asking them about their perceptions of what we Healthcare (http://www.saferhealthcare.com/) can do to improve their work environment and the quality of patient care,” says Steiert. “I touch the staff icon and the questions appear.” (See sidebar.) Questions for staff • On a scale of 1 to 5 overall [1 is low, 5 is high], how are things working in this department? • Is there anything you can think of specifically that is working well in this unit or department? • Is there anything you can think of that is not working well in this unit or department? “I can record their voices when they give me their answers, or I Source: MyRounding Solutions, Littleton, Colorado. can put the data into the

76 The OR Management Series Patient Safety in the OR iPad as we are talking,” says Steiert. “I also can take photographs, so if I am on a unit and I see something that my staff doesn’t like, I can take a picture of it, and that can be stored data as my justification for my rationale to make a change.” (See sidebar.) Questions for surgeons For the surgeons’ questions, Steiert touch- es the surgeon icon and a script and questions appear, and then she records the surgeons’ answers. The script begins with: “Dr X, would you Source: MyRounding Solutions, Littleton, Colorado. mind spending a mo- ment with me to talk about • Do you feel that all members of your care team patient safety and quality improvement in the understand and agree on your plan of care? OR? We are trying to be proactive and address Yes or No. any concerns and capture any ideas that you may • Do you feel like you had a voice in your plan of have that can help us improve our patient care.” care with all members of your care team? Yes • On a scale of 1 to 5, how would you rate the or No. quality of nursing in the OR? • Do you feel like we have kept your family • Are there any concerns or ideas that you members up to date and informed about the would like to share about patient safety here progress in your procedure today? Yes or No. in our OR? Yes or No. • Is there anything we could have done better to • Are there any quality improvement projects help you or your family? Yes or No. that you think would be beneficial to our de- • Do you have any last questions or concerns? partment? Yes or No. • On a scale of 1 to 5, how satisfied are you over- Questions for the family all here in our department? Questions the nurse liaison asks family mem- • Is there anything I can do personally to help bers begins with a script: “I just want to check in you make your practice in our OR more effec- with you to see how you are doing and give you tive? Yes or No. an update.” The nurse then tells them about the current sta- • Is there anyone who you would like to recog- tus of the patient and asks the following questions: nize for going above and beyond the norm? • Is there anything I can do to make you more At the end of the interview, Steiert presses a comfortable while you are waiting? Yes or No. button to save and start a new interview. “It works quickly,” says Steiert. “About 5 min- • Is there any additional information you need, utes of their time is all I need.” or are there any questions I can answer for you? Yes or No. Nurse liaison rounding questions • Are you able to follow the progress of your fam- After a nursing liaison position was added in ily member using our patient board? Yes or No. November 2013, a series of questions were created • Would you like me to continue to check in with for the nurse liaisons to ask patients and their you to monitor the situation? Yes or No. families. Two nurses share the position. “I like the last question, especially,” notes Stei- Questions for patients ert. “Knowing the nurse will be there if they have questions is comforting to them.” • Do you understand your plan of care and what to expect from admission to discharge? Yes or No. Trending the issues • Is there any additional information that you With the stored information, the MyRounding would like, or do you have any questions? Yes software identifies trends and issues and com- or No. piles statistics on the data.

Patient Safety in the OR The OR Management Series 77 could have done to make it better, he answered: “Yes, we could only find 1 Kleinert-Kuts elevator for this special procedure.” He said the procedure was designed by these 2 surgeons and it goes better when their elevators are used. Steiert went to the surgical processing department and asked how many Kleinert-Kuts elevators they had and if they were included in the hand sets or if they were put up separately in peel packs. She found they were down to 1 elevator, and it was in a peel pack. She ordered 5 additional elevators so 1 could be in every hand set. She followed up with the hand surgeon the next day, tell- Source: MyRounding Solutions, Littleton, Colorado. ing him she had ordered 5 more that would be in all of the hand “The tool helps us close the loop on issues be- sets the following week. cause it trends the issues, which helps us resolve them,” says Steiert. Effectiveness of tool For example, 1 of the top trends identified was Steiert says in the next 3 months they should that staff and surgeons were focused on getting first- have a lot more data and will be able compare case patients into the OR on time. A corresponding surgeon, staff, and patient satisfaction before and trend was that patients were delayed going into the after they began rounding with the tool. OR because their H&Ps weren’t on the chart. Perioperative leadership surveyed staff and An A3 Lean methodology was used to deter- surgeons before they started rounding about mine why the H&Ps weren’t on the chart and what their level of satisfaction with the way things needed to be done to have them on the chart in a were going in the department. In a few months, more timely fashion. they will do a post-survey to see if there is a dif- “We worked with the surgeons’ offices, PAs, ference. fellows, and IT to discover the obstacles and how Already, Steiert says, comments from sur- to overcome them,” notes Steiert. geons, the executive team, and staff indicate As a result, Steiert says, they figured out the they have noticed an improvement in patient latest possible time to stop looking for an H&P, care and customer service. Instrumentation call the surgeon, and get the patient into the room and equipment is ready sooner, and patient on time. “One thing nurses don’t like to do is call satisfaction scores have improved across the the surgeon, especially for the first case of the day, organization. ✥ saying ‘we can’t find your H&P,’” she says. —Judith M. Mathias, MA, RN Steiert says they worked backward to accomplish this, asking: “If we want the patient in the room by Resources 7:29 am, what needs to happen before that time?” Centers for Medicare & Medicaid Services. It helped create a whole process for standard- HCAHPS: Patients’ perspectives of care survey. izing work, she says. For example, they are trying http://www.cms.gov/Medicare/Quality-Initia- to standardize all the work the night nurses need tives-Patient-Assessment-Instruments/Hospital- to do to have things ready for the day shift for the QualityInits/HospitalHCAHPS.html first case of the day and what the evening shift Institute for Healthcare Improvement. Rounding to needs to do to help the night shift. “It has sparked influence: Leadership method helps executives an- more work than we have time to do, but it is fun swer the “hows” in patient safety initiatives. 2011. and people are getting energized,” says Steiert. Another example: A hand surgeon from the Stead- http://www.ihi.org/knowledge/Pages/Publica- man Clinic was doing a case during the Thanksgiv- tions/RoundingtoInfluence.aspx ing holiday when the ski slopes opened, and many Marshall D. Leadership rounding on the front lines. people were coming in with injuries. There was a Safer Healthcare. 2013. particular elevator missing from 1 of his hand sets. http://myrounding.com/images/files/Best_Prac- When Steiert did her rounding the following tice_-_Leadership_Rounding_-_2-19-2013.pdf Monday, she asked him how things went over the weekend because she knew he had been on call. When she asked him if he was satisfied with the care This article originally appeared in OR Manager, his patients received or if there was something they March 2014;30:6-9.

78 The OR Management Series Patient Safety in the OR South Carolina models high reliability standards through pilot program

he South Carolina Hospital Association “We have been very encouraged by the number (SCHA) and the Joint Commission Center of hospitals that responded initially,” Dr Foster T for Transforming Healthcare have teamed says. “The 8 systems represent about 40% of patient up to make the state’s healthcare highly reliable. discharges in the state, so it represents a pretty In a joint project titled “South Carolina Safe Care good percentage of our inpatient work.” Commitment,” 21 hospitals in South Carolina are learning about high reliability practices (chart). Leadership commitment High reliability is defined as consistent per- “Striving for high reliability is not just another formance at high levels of safety over long pe- project—it is a long-term commitment to funda- riods of time. Highly reliable healthcare is care mental and social change in our hospitals and that is dependably excellent, every time, for health systems,” says Dr Foster. “We were very every patient. intentional about including the term ‘commit- The multiyear project, launched in February ment’ in the name.” 2013, was built on a combination of the work South Hospital CEOs cannot commit to the program Carolina was doing with a collaborative model and then turn it over to someone else in the to improve the quality and safety of patient care organization to lead the effort. “We told them and the platform of work the Joint Commission they need to turn it over to themselves and stay had done around the 3 key components of highly actively involved,” he says. reliable organizations, says Rick Foster, MD, se- Participating hospitals sign a 3-year commit- nior vice president for quality and patient safety ment promising that their CEOs and leadership at SCHA. teams will be actively involved. Those leaders are The 3 components are: expected to: • full leadership commitment and participation • complete the Joint Commission’s High Reli- in driving a system to high reliability ability Self-assessment Tool • an organization-wide culture of safety • perform a safety culture survey assessment • system-wide application of robust process im- • use a common process to identify events of harm provement (Lean, Six Sigma, Change Manage- and close calls that will help facilitate the development) (figure). ment of a standardized high reliability measure.

Printed with permission from the South Carolina Safe Care Commitment project.

Patient Safety in the OR The OR Management Series 79 parks, and nuclear power in that they tend to focus on reviewing and taking action only when harm actually occurs, whereas the other organizations also look at their near misses, says Dr Foster. “We hope to have a system that helps hospitals better track events that might lead to harm, which has been an area that has been difficult to measure,” he says. By the second year, Dr Foster says, hospitals should have better baseline statistics on their rates of harm and near misses. Safe Surgery program One of the preexisting initiatives SCHA is involved in that Dr Foster says provided the foundation for Printed with permission from the South Carolina Safe Care their move toward high reliability is Commitment project. the Safe Surgery program. As part of this program, carried out in partnership with Atul Gawande, MD, and Ultimately, participating facilities will receive his team at Harvard’s department comparative information from peer organizations of health policy and management, Boston, all on these key high reliability metrics. South Carolina hospitals committed to putting the World Health Organization’s Surgical Self-assessment tool Safety Checklist into routine use in their ORs Each hospital has a leadership team led by its by the end of 2013. CEO that participates in up to 3 in-person meet- “When you look at the level of leadership ings each year with SCHA and the Center for engagement, the culture, the environment where Transforming Healthcare, along with a series of staff work, and the opportunity to reduce inva- webinars and coaching calls. sive harm and near misses in the OR, there is During the first meeting, the teams were pro- no other area from a hospital standpoint where vided information on high reliability in general, I think the principles of high reliability apply and then they heard from hospitals that were more,” says Dr Foster. already successfully applying practices to achieve SCHA has been working with every acute care consistent excellence in patient care. hospital in the state as well as a number of ambu- Each hospital completed the High Reliability latory surgery centers to implement the checklist Self-assessment Tool developed by the Joint Com- and change the way surgical teams communicate. mission and received a report back from the Joint They have been tracking process and outcomes Commission team. Hospitals used the report to measures, and they hope to complete a formal move forward with their individual high reli- report by the first quarter of 2014, he says. ability plans. Dr Foster noted that 1 hospital is using the The South Carolina Safe Care Commitment is debriefing part of the checklist to track near part of a beta testing group for the tool, says Dr misses. “It was the first time a surgical team Foster. reported that they hadn’t had a wrong-site or wrong-patient surgery in 2 years, but they had Standardized safety reports 4 situations in the past week that could have led At the meetings, the SCHA and Joint Commis- to an error. The checklist totally changed the sion teams also looked at each hospital’s existing way they look at errors,” says Dr Foster. culture of safety surveys. All but 2 organizations Thanks to the Safe Surgery program, SCHA in the state were using surveys from the Agency has built a strong network of physician cham- for Healthcare Research and Quality (AHRQ). pions across the state that includes anesthe- Dr Foster says they are looking at a standard siologists and surgeons who are some of the system for safety culture reporting and will begin individuals responsible for looking at how to using Healthcare Performance Improvement’s spread high reliability across the organization. Safety Event Classification system as a uniform reporting system to allow hospitals to track near Lessons learned misses. This system is already being used by Beyond the 21 hospitals initially participating many hospitals that are moving toward high reli- in the initiative, the South Carolina Safe Care ability, he says. Commitment is designed to improve safety and Healthcare systems differ from high reliability quality in healthcare organizations across the industries like commercial aviation, amusement state.

80 The OR Management Series Patient Safety in the OR The initial cohort of hospitals has been willing References to share and learn from one another, and they will http://www.safesurgery2015.org/about-us.html help spread this model to the newer cohorts. The idea of having multiple overlapping co- http://www.scha.org/south-carolina-safe-care- horts is that the first group of hospitals becomes commitment mentors and coaches for the next group, says Dr http://www.scsafecare.org Foster. Hospital participation and progress in moving This article originally appeared in OR Manager, toward high reliability will be recognized annu- January 2014;30:1, 12-13. ally at the first meeting each year. ❖ —Judith M. Mathias, MA, RN

Patient Safety in the OR The OR Management Series 81 Targeted Solutions Tool helps banish communication barriers during surgery

rocess and communication concerns led Use team approach OR management at the University of Flor- Before implementation of the Surgical Safety Pida Health Shands Hospital, Gainesville, Process, the circulating nurse and the anesthesi- to implement a Surgical Safety Process using ologist performed a time-out when the patient the Joint Commission Center for Transforming was brought into the OR. This consisted of patient Healthcare’s Targeted Solutions Tool (TST) for identification and anything pertinent to the pa- Wrong Site Surgery. tient’s anesthesia. “When we reviewed our patient safety reports, A second time-out was done when the surgeon what came to the surface loud and clear was that we arrived. A third time-out was performed after the could be communicating better,” Diane Skorupski, patient was anesthetized and before the incision MS, RN, CNOR, NE-BC, told OR Manager. was made. “The reports showed us there were opportuni- Now a briefing is done in the OR before induc- ties for improvement in our process, and we chose tion with all parties present. the TST to help identify those opportunities,” says “What we clearly identified was that we want- Skorupski, associate vice president for periopera- ed more of a team approach, and we wanted tive services at Shands. everyone to come together—the surgical tech- Even though the TST is labeled Wrong Site nologist, surgeon, RN, and anesthesiologist—and Surgery, notes Skorupski, “it’s more than that—it’s have a discussion about the plan of care with the really a Robust Process Improvement method to patient before induction,” says Skorupski. reduce process errors across the system, including The briefing is started by the surgeon or anes- scheduling, preoperative, intraoperative, and post- thesiologist, who asks, “Is everyone ready for our procedure.” briefing?” Team members introduce themselves Identify problems and discuss the points in the briefing. The patient also participates in the discussion. To identify process problems, leadership and “We have found that patients love being in- staff trained on the TST performed 100 audits in volved in the process, especially the introduc- each area—scheduling, preoperative, and intraop- tions,” notes Skorupski. erative. The audits took about 3 weeks to complete. At first, some team members objected to in- Sifting through the information gleaned by the troducing themselves to each other because they audits was “exciting,” says Skorupski. “The TST work together all the time. But the chairman of easily identified where we were hitting the mark surgery pointed out that they were not introduc- and where we needed to address process issues.” ing themselves to each other but to the patient. Like the patient safety reports, the TST found “Once they started thinking of it that way, communication to be a problem. there was no longer a problem,” she says. Skorupski, the chairman of surgery, and the During their postoperative rounds, the sur- medical director—who is an anesthesiologist— geons say, patients tell them how wonderful it was presented the findings of the TST, opportunities to be introduced to the people who would be tak- for improvement, and the new Surgical Safety ing care of them while they were under anesthesia. Process during a multidisciplinary grand rounds. The safety process includes a briefing, time-out, Customize briefing and debriefing. No surgery was scheduled dur- to the patient ing this time, and 800 people attended, includ- Skorupski says they tried very hard to keep ing nurses, surgical technologists, surgeons, resi- the number of discussion points to a minimum dents, and anesthesia providers. and told team members to customize the brief- The attendees were told they would be coached ing to each patient. For example, a pediatric on how to do the briefing, time-out, and debrief- hernia patient would not be on beta blockers, ing, and their practice would be audited. so that type of discussion would not be neces- Currently the auditors document their find- sary. “This was a new thought to them because ings on paper, but soon they will do the audits most were used to a checklist where they had to on an iPad and download the findings onto a go through each bullet,” she says. Pareto chart.

82 The OR Management Series Patient Safety in the OR Surgical Safety Process – UF&Shands

BRIEFING (In OR) TIME-OUT DEBRIEFING Pre-induction/procedure Pre-incision Pre--emergence Stop called by attending anesthesiologist Stop called by surgeon/proceduralist Stop called by circulating nurse/assigned team and attending surgeon/proceduralist before surgical incision/procedure start. member upon surgeon’s notiﬁcation that before induction and before prep. wound closure is beginning or procedure is nearing completion. Notify Attending Anesthesiologist of anticipated debrieﬁng.

˘ INTRODUCTION OF TEAM MEMBERS ˘ CORRECT PATIENT ˘ ATTENDING SURGEON INITIATES ˘ CORRECT PATIENT ˘ SITE MARKED & VISIBLE ˘ CAVITY/WOUND CHECK ˘ ID x 2 ˘ CONSENT/PROCEDURE ˘ STATUS OF FIRST COUNT ˘ Electronic ID ˘ ANTIBIOTICS ˘ SPECIMENS ˘ CONSENT/PROCEDURE ˘ BLOOD AVAILABLE? ˘ BLOOD RETURNED ˘ SITE MARKING ˘ ANY CONCERNS? ˘ FAMILY CONTACT? ˘ ALLERGIES ˘ Vital Signs ˘ ANY EQUIPMENT ISSUES? ˘ ANTIBIOTICS ˘ Anesthesia ˘ ANY CHANGE IN DISPOSITION? ˘ MEDICATION VERIFICATION ˘ ARE WE READY TO GO? ˘ REPORT CALLED? ˘ Current meds ˘ ANY CONCERNS? ˘ Anticoagulants? ˘ BLOOD ˘ H&H available? ˘ ABO veriﬁcation? ˘ Units available? ˘ POSITIONING ˘ SCIP MEASURES ˘ Beta Blocker ˘ DVT Prophylaxis ˘ Antibiotic ˘ Normothermia ˘ CASE SPECIFIC ˘ Implants available? ˘ Equipment ˘ IMAGING DISPLAYED/CORRECT ˘ POSTOP DESTINATION? ˘ ANY SPECIAL CONCERNS ˘ Patient Speciﬁc ˘ ARE WE READY TO BEGIN?

A “Pause” is required for change in physician performing the procedure, change in patient position or prior to starting another surgical or invasive procedure (i.e. completing procedure on index ﬁnger, starting procedure on thumb) Reprinted with permission from the University of Florida Health. Shands Hospital, Ganinesville.

Specialty teams known as colleges (see OR up. The circulating nurse reads the patient’s Manager, July 2013, pp 1, 6-9) were consulted name, ID number, and procedure from the con- about which discussion points they wanted sent form. in the briefing, and a staff-driven committee “All 3 are involved in the identification of the decided which points to include. “Now, if a patient at the start,” notes Skorupski. situation comes up, the first thing people say Once the patient identification process is com- is, ‘Let’s add it to the briefing points,’ so we pleted and the team is assured of the correct pa- have to be careful we don’t keep adding to the tient and procedure, the surgeon scans the brief- list to the point that it becomes unwieldy,” says ing discussion points, which are posted on a 3- by Skorupski. 5-foot laminated poster in each OR, and discusses After team members introduce themselves, any pertinent information with the other team they check the patient’s identification (ID). The members (sidebar). surgeon confirms the patient’s name and ID num- In a typical discussion, the surgeon might ber on the wristband, and the anesthesiologist ask if there are any unusual medications the checks the name and ID number on the computer patient might be taking or other special con- to make sure the correct patient record is pulled cerns to discuss. The anesthesiologist might

Patient Safety in the OR The OR Management Series 83 say, “We are concerned about the potential of departments. This way, for example, the sterile a difficult airway and will be taking the follow- processing department will be notified if scissors ing special precautions.” need to be sharpened. The surgical technologist might ask if there If a scheduling problem with the case surfaces needs to be antibiotics in the irrigating fluid on during the debriefing, that information will go the sterile field. right to the scheduler, so there will be real-time The circulating nurse might show the surgeon feedback. an implant to make sure it is the correct one. The debriefing is a way to empower the staff, After the team discusses all the relevant points, and Skorupski hopes they will come to appreciate the surgeon asks, “Are we ready to begin?” This what an important part of the process it is. question is important, Skorupski says, because it invites team members to acknowledge whether Pause for change they are ready. A pause is required for a change in the surgeon If the surgeon instead said, “Let’s get started,” performing the procedure, change in patient posi- the discussion would be cut off, she says. tion, or before a second procedure on the same patient is started. Shorten the time-out During the pause, for example, the circulating After the briefing, the patient is anesthetized, nurse will read from the consent if it is a second prepped, and draped. Before the knife is passed, procedure and say, “Yes, that is the procedure we the surgeon or resident initiates the time-out. are doing.” “The time-out is crisp,” says Skorupski, “because we covered all of our bases in the briefing.” Promote communication The surgeon asks if everyone can see the site To promote communication, the RNs are par- marking and if the antibiotic is in. The anesthe- ticipating in simulation training. siologist says the patient has been induced, vital “We want them to speak up—to say ‘No, we signs are stable, and the antibiotic is in. can’t start this case’ or ‘No, we can’t go any fur- Then the surgeon asks, “Are we ready to go?” ther until blood has been drawn,’” says Skorup- All team members verbally respond to the question. ski. “The training is going over well,” she adds. Check on any concerns Skorupski says she is seeing an improvement in communication when she rounds. “The debriefing is supposed to start as the The surgeons tell her it is good to get everyone wound closure is beginning or near completion, together at the beginning of the case and have a but we are still struggling with the best time to conversation. start the debriefing,” notes Skorupski. Sometimes The circulating nurses and surgical tehnolo- the surgeon leaves and the resident closes. “We gists say they are more prepared for the proce- are trying to define a point in time that will trigger dure because they learn at the beginning of the the debriefing,” she says. case the supplies that might be needed even if A month ago, Skorupski says, they decided to they are not listed on the preference card. put stop signs on the doors of each OR to remind “What I am seeing is more of an esprit de surgeons to debrief. The sign asks, “Did you de- corps in the OR since kicking off the Surgi- brief?” cal Safety Process last May,” says Skorupski. The circulating nurse calls a stop as the wound “There is more [a spirit] of ‘Yes, we are all on closure begins and says, “It’s time to debrief.” the same page,’ and we are all taking care of The circulator reviews the discussion points, our patient and recognizing our patient as an saying, for example, “All specimens are off the important person who we have to communi- field and labeled, and pathology slips are made cate with.” ❖ out.” —Judith M. Mathias, MA, RN If unused blood is going with the patient to the ICU, that is acknowledged. The surgeon might say the Potts scissors Reference seemed dull and need to be sharpened. Joint Commission Center for Transforming Health- The surgeon contacts the family, and the circu- care Targeted Solutions Tool for Wrong Site Sur- lating nurse calls the report to the postanesthesia gery. http://www.centerfortransforminghealthcare unit or ICU. care.org/tst_wss.aspx To end the debriefing, the surgeon or circulating nurse asks, “Are there any concerns?” When the OR goes live on Epic in May 2014, Skorupski says she wants to make the debriefing This article originally appeared in OR Manager, electronic so there is an automatic feed to other January 2014;30:14-16.

84 The OR Management Series Patient Safety in the OR IV. Preventing Infections

Patient Safety in the OR The OR Management Series 85 Are you on target for meeting SSI, SCIP metrics?

R leaders will want to check that their part of Medicare’s inpatient quality reporting surgical site infection (SSI) rates are in line program in order to report data on central line- Owith 5-year goals in the updated National associated bloodstream infections. Action Plan for reducing health care-associated infection (HAI) from the Department of Health Surveyor tool for hospitals and Human Services (HHS). The state survey infection control tool is in- By and large, hospitals are on target to meet tended to improve the quality and consistency of SSI goals by the end of 2013, HHS reports. But surveys, HHS says. they can’t let up. The hospital tool was piloted in several states Two of the action plan’s 9 goals directly relate in 2011, expanding to all states in 2012. Starting to surgery: in federal FY 2013, the tool will be used in all • 25% reduction in SSIs state surveys of hospitals, according to Centers for Medicare and Medicaid Services (CMS) plans. • 95% adherence to SCIP measures, referring to CMS says it is also providing surveyors with more the Surgical Care Improvement Program. training and requiring accreditors like the Joint Com- HHS plans to keep the focus on infection pre- mission to make infection control a priority. vention with a new tool for use in state validation Hospitals were cited for infection control de- surveys, based on the one already used for ambu- ficiencies in 1.7% to 2.3% of regular state surveys latory surgery centers (ASCs). between 2007 and 2010, HHS reports. The action plan was posted for comment on April 19, 2012, with comments accepted through Focus for perioperative leaders June 25, 2012. Greene suggests that perioperative managers and Phase 1, rolled out in 2009, focused on hospi- directors review their infection prevention program tals. Phase 2 extends to ASCs and dialysis clinics, to be sure it is in line with the HHS action plan: with Phase 3 planned for long-term care. • Review the pilot state surveyor infection con- Progress on SSIs trol tool to see what areas surveyors will be looking at. SSIs decreased by 10% for 2010 from the 2006- 2008 baseline period, HHS notes, and during “Although the tool is currently being 2010, 8% fewer SSIs were reported than predicted. piloted, it addresses important structure, pro- The biggest improvement over the past 2 years cess, and outcome measures that are part of was for coronary artery bypass graft (CABG). Small- a robust infection prevention plan,” Greene er reductions were seen for 2 of the other procedures says. This includes OR-specific issues such as evaluated, knee arthroplasty and colon surgery. disinfection, sterilization, and cleaning. “We are moving in the right a direction, and • Know how your organization is doing on its that is definitely good news,” says Linda Greene, SSI metrics: MPS, RN, CIC, director of infection prevention —surgical infection ratios (SIR) and control for Rochester General Health System —SCIP compliance. in Rochester, New York. Central line infections fell by 33%, and in- (Hospitals that have a low denominator may not vasive methicillin-resistant Staphylococcus aureus be able to calculate an SIR for a single quarter.) (MRSA) infections were down by 18%. • Check your SIR data for colon surgery and The same could not be said for Clostridium dif- abdominal hysterectomy for the first quarter ficle infections, which are at historic highs—75% of 2012, if available. now begin outside the hospital in settings such as Hospitals were required to begin reporting nursing homes and outpatient clinics. their SSI data for these 2 procedures to CMS on The data is from the Centers for Disease Con- January 1, 2012, to qualify for a full Medicare pay- trol and Prevention (CDC) surveillance system, ment update in 2014. the National Healthcare Safety Network (NHSN). Your hospital’s SSI rates for these procedures Over 5,000 facilities are enrolled in NHSN. eventually will be reported to the public on Medi- Hospitals are required to participate if they are care’s Hospital Compare website.

86 The OR Management Series Patient Safety in the OR National standardized infection ratios (SIRs) for surgical site infections* 95% CI for SIR

SIR Lower Upper

Hip arthroplasty 0.971 0.914 1.030

Knee arthroplasty 0.892 0.840 0.947

Coronary artery bypass graft 0.820 0.766 0.876

Cardiac surgery 0.835 0.692 1.000

Peripheral vascular bypass surgery 0.935 0.718 1.196

Abdominal aortic aneurysm repair 0.648 0.255 1.363

Colon surgery 0.909 0.853 0.968

Rectal surgery 1.285 0.854 1.857

Abdominal hysterectomy 1.065 0.964 1.174

Vaginal hysterectomy 1.243 1.006 1.520

Source: Centers for Disease Control and Prevention. *Data from all NHSN facilities during 2010, using only SSIs that were classified as deep incisional or organ/space and detected on admission or readmission.

Get to know your SIR • SCIP Inf 2: Antibiotics consistent with recom- Become familiar with SIR, the metric the CDC mendations and CMS now use to report SSIs and other HAIs, • SCIP Inf 6: Appropriate hair removal. Greene recommends. But 2 metrics had not yet reached the 95% goal: Note whether your SIRs are better or worse • SCIP Inf 3: Antibiotics discontinued within 24 than average. hours after surgery “You don’t want to be blind-sided by this,” she advises. • SCIP Inf 4: Glucose control for cardiac surgery The SIR compares a facility’s actual number patients. of SSIs with the US experience, adjusted for risk The 2010 data was not yet available. factors: • A SIR significantly higher than 1.0 indicates The pilot CMS infection control survey tool is more infections were observed than predicted. available at http://www.aimediaserver6.com/ ORManager/HHS%20Hospital%20Infection%20 • A SIR significantly less than 1.0 indicates fewer Control%20Surveyor%20Tool%20050112.pdf SSIs than predicted were observed. SCIP progress The National Action Plan is available at www. hhs.gov/ash/initiatives/hai/actionplan/index.html According to the latest available data from 2009, hospitals were exceeding 95% compliance for 3 of 5 SCIP-Infection metrics: This article originally appeared in OR Manager, • SCIP Inf 1: On-time antibiotic administration June 2012;28:22-23.

Patient Safety in the OR The OR Management Series 87 Curbing OR traffic: Finding ways to minimize the flow of personnel

traffic cop? Stop signs? Flashing lights? Is culture and standardized protocols (OR Manager, there a way to curb the number of people February 2010, pp 16-18). Apassing in and out of ORs during cases? Staff are cautioned that excessive in-and-out The number during a lengthy major surgery can traffic during surgery is a distraction that can reach a dozen or more, with door openings every contribute to infection and errors, says Marie minute or two. Paulson, BSN, MS, RN, CNOR, the region’s direc- Door openings affect the OR’s ventilation tor of perioperative services. She acknowledges system. The more people, the more bacteria. In a “it’s a fine balance, to provide training and have new study led by Andersson, et al, from Sweden, the appropriate staff in the room.” the OR traffic rate was linked to high bacterial Circulating nurses are encouraged to coordi- counts close to the surgical wound (sidebar). nate activity during cases. Door openings also add to distractions and in- “If the circulator identifies too many are pres- terruptions, possibly affecting team performance ent, she needs to take accountability for patient and surgical outcomes, Healey and colleagues care and ask them to leave,” Paulson says. Cir- observe in a 2006 study. culators are also encouraged to ensure personnel, There is no recommended limit to the number such as vendor representatives, are in the room of personnel in a surgical case. The Centers for only for the time needed. Disease Control and Prevention and AORN ad- Staff are instructed not to use ORs as shortcuts vise that the number be minimized. to the sterile core and are asked not to stick their heads in a room just to say hello. Why door openings? In the Swedish study, 32% of door openings Staff relief were considered unnecessary. Of these: Though staff breaks are necessary, the ex- • 55% had no discernible reason change of personnel contributes to traffic and • 27% were for social visits raises the risk of losing critical information during a handoff. Some organizations have re-examined • 18% were for logistical planning for other op- how they manage breaks. Managers considering erations. changes should consult with their HR depart- Among major reasons were: ments and review their state’s labor laws. • supply issues: 26% As part of Highly Reliable Surgical Teams, Kai- ser has identified critical events during surgery • staff breaks: 20%. when safety can be compromised: Only 7% were related to the need for expert • the time-out to verify information about the consultation. patient and case OR personnel apparently think all of the in- and-out is necessary. Even when teams knew they • site mark verification before the incision after were being observed, the number of door openings prepping and draping and closings didn’t change, in a study led by Shital • surgical counts, whether for relief or the final Parikh, MD, from Cincinnati Children’s Hospital count Medical Center. (See sidebar on research.) • critical events during the case deemed by Blaming individuals isn’t the answer, say the the physician, such as aortic cross-clamping, Swedish authors. They suggest organizational inserting a carotid stent, or inserting a joint changes, such as raising the knowledge level and prosthesis. improving logistics and preoperative planning. Though staff relief is managed by each facility, Some ORs have introduced changes that have the general recommendation is for OR staff not reduced traffic. to accept breaks routinely during these critical Curbing traffic times, Paulson says. Facilities in Kaiser Permanente’s Southern Planning for relief California region have taken steps to limit traf- In the Kaiser facilities, it is suggested that be- fic as part of the Highly Reliable Surgical Teams fore each case, the OR team discuss relief with the program. The program emphasizes a team-based physicians during the time-out.

88 The OR Management Series Patient Safety in the OR OR traffic: Research highlights

Door openings and bacterial counts The OR door open for an average of 6.4 min- OR traffic, including a high rate of door utes (10.7%) of each hour of operating time. openings, was linked to high bacterial The authors note a “possible trend” to- counts close to the surgical wound, in a ward increased SSIs with increased levels Swedish study of orthopedic trauma cases. of OR traffic. In only 7% of the cases were door open- —Young R S, O’Regan D J. ings related to expert consultation. The lead- Interact Cardiovasc Thorac Surg. 2010;10: ing reasons were: 526-529. • supply issues: 28% • staff breaks: 20%. Foot traffic in OR More than one-fourth (27%) involved so- An observational study recorded 19 to 50 cial visits or no detectable reason. traffic events per hour for 28 cases in all spe- —Andersson A E, Bergh I, Karlsson J, et al. cialties. The preincision period represented Am J Infect Cont. 2012. Online ahead of 30% to 50% of all events, with information print. requests accounting for the majority. —Lynch R J, Englesbe M J, Sturm L, et al. Door openings and distraction Am J Med Qual. 2009;24:45-52. Door openings averaged 33 per case in a study of 50 general surgery operations Monitoring does not curb traffic in a single OR in the UK. The researchers Monitoring alone may not be sufficient to observed an average of 1 interruption per limit OR traffic. minute, with a possible impact on team A study observing traffic in pediatric performance and surgical outcomes. orthopedic ORs found no difference in traf- —Healey A N, Sevdalis N, Vincent C A. fic when OR personnel were notified they Ergonomics. 2006;49:589-604. were being observed and when they were not. Cardiac OR traffic The average number of door swings per Researchers in the UK studying 46 cardiac hour was about 40. Door swings could cases in 2 ORs found: reach 200 in a long case, such as spine sur- • an average of 92.9 door openings per case gery, which can last 5 hours. • a rate of 19.2 door openings per hour in 2 —Parikh S N, Grice S S, Schnell B M, et al. cardiac ORs. J Pediatr Orthop. 2010;30:617-623.

For example, for a 3-hour case starting at 9 am, The focus is always on “what is in the patient’s there typically would be a break and perhaps a best interest,” she notes. “Patients deserve the meal. During the time-out, the circulating nurse best team who knows their needs and has the best would say to the surgeon and anesthesia provid- understanding of what is going on.” er, “Is there a time, other than the critical times, when you would want me to wait to take a break? Limiting morning breaks Otherwise, I will let you know when it is time. If Ogden Regional Medical Center in Ogden, it is not an appropriate time, please let me know.” Utah, decided to limit morning breaks for its 7 The nurse is not asking permission, Paulson ORs after much discussion with the staff. explains, but rather alerting the team when break The staff were OK with the change once they time arrives. understood the reasons—safety for the patient When relieved, the nurse says, “Dr Jones, I’m because of better infection control and fewer com- going to be relieved. I am giving Sally a report.” munication lapses, says Lori Gordon, RN, direc- Physicians have been receptive to this practice, tor of surgical services. “We realized breaks are she says. As part of the team-based culture, team disruptive,” Gordon says. “People were trying to members introduce themselves at the start of a hurry, and sometimes information wasn’t passed case and introduce their relief person, which aids on.” Plus, changing scrub persons increased the communication. chance for a break in technique. Kaiser is unionized. Paulson says the staff and Staff who don’t have a break in the morning labor partners “were receptive and supported the may take a longer lunch or leave early. Gordon highly reliable aspects of patient care, so this has not also tries to provide inexpensive treats that the been a problem. We still provide breaks and meals staff appreciates, such as free soft drinks in the and comply with all state and federal regulations.” lounge.

Patient Safety in the OR The OR Management Series 89 ‘Do not enter’ sets and implants are ordered for cases in ad- Staff generally are not relieved during cases vance, which also helps in preparing for cases and such as total joint replacement and major spine avoiding unnecessary traffic. surgery at Holland Hospital in Holland, Michi- Starting longer cases early gan. During these cases, a “do not enter” sign is As much as possible, at Cincinnati Children’s, placed on the door. major cases such as spine surgery and joint re- Total joint cases generally last 1 1/2 to 2 hours, construction are started early in the day so they and major spine cases can run 4 to 6 hours. can be finished before the shift change at 3 pm, Both staff and anesthesia providers are asked Dr Parikh notes. A shift change with its change to abide by the limit, notes Kathy Shaneberger, in personnel means more traffic, a greater risk of MS, RN, CNOR, director of surgical services. information loss, and disruption of OR flow. Enlisting technology Limiting numbers of personnel Display screens and wireless communication badg- Though there are often good reasons for vendors, es are ways technology is helping to reduce traffic. students, and trainees to be present during surgery, Cincinnati Children’s uses a computerized facilities are taking steps to minimize the numbers. system to track patient status, Dr Parikh notes. Cincinnati Children’s limits students to 1 to 2 Nurses can click a tab in the hospital’s Epic soft- at a time per case. Observers must be approved by ware to record the patient’s status. The status is the residency coordinator to make sure others are displayed on monitors at the OR’s front desk. not scheduled for the same case, Dr Parikh notes. “We can look at the board and know where the Like many facilities, Ogden Regional requires patient is. That has eliminated a lot of traffic for vendor reps to be credentialed and to check in information purposes,” says Dr Parikh, a pediat- when they arrive. ric orthopedic surgeon. Vendors are asked to limit personnel in the fa- Ogden Regional Medical Center and Holland cility to one per company at a time, Gordon says. Hospital employ Vocera, a wireless communica- They are asked to limit time in the OR to what is tion system that uses push-button badges and pertinent to the case. smartphones (www.vocera.com). A focus on patients’ safety coupled with com- “With Vocera, the staff does not have to leave munication technology and systems changes that the OR to communicate. It’s like a phone but enable better case preparation are tactics that have quicker,” says Gordon. aided these organizations in keeping traffic down, Circulating nurses can easily call the anesthe- which reduces air turbulence and creates a calmer sia provider when a room is ready, for example. environment for the entire surgical team.❖ Or the nurse can call sterile processing to request —Pat Patterson an instrument. Gordon wears a Vocera badge herself to help References in managing the schedule. “The staff will call me Andersson A E, Bergh I, Karlsson J, et al. Traffic if something has changed,” she says. flow in the operating room: An explorative and For additional traffic control, OR assistants’ descriptive study on air quality during orthope- role has been expanded to include responsibility dic trauma surgery. Am J Infect Control. 2012. for providing equipment for cases. Online ahead of print. Additional ideas AORN. Recommended practices for traffic patterns in the perioperative practice setting. Periopera- Other steps organizations have taken to limit tive Standards and Recommended Practices. traffic: Denver, CO: AORN, 2012. Surgeon request form Centers for Disease Control and Prevention. Guideline When scheduling a case, surgeons at Cincinnati for prevention of surgical site infection, 1999. www. Children’s fill out a Surgeon Request Form. The form, cdc.gov/hicpac/pdf/guidelines/SSI_1999.pdf faxed to the OR’s scheduling desk at posting, records Healey A N, Sevdalis N, Vincent C A. Measuring the surgeon’s estimate of incision-to-close time and intra-operative interference from distraction and any special needs for the surgery. (The form is in the interruption observed in the operating theatre. OR Manager Toolbox at www.ormanager.com.) Ergonomics. 2006;49:589-604. “This helps us to communicate preoperatively Parikh S N, Grice S S, Schnell B M, et al. Operating what we will need during surgery,” says Dr Parikh. room traffic: Is there any role of monitoring it? J Preference cards are kept up to date so cases Pediatr Orthop. 2010;30:617-623. can be set up accurately, minimizing the need to What makes an OR “highly reliable”? OR Manager. leave the OR. 2010;26(2): 16-18. Designated OR coordinator A designated OR coordinator for orthopedics This article originally appeared in OR Manager, works with the surgeons and vendors at Cincin- nati Children’s to ensure the proper instrument June 2012;28:1, 9-11.

90 The OR Management Series Patient Safety in the OR Joint project targets prevention for colorectal surgical infections

even hospitals working with the Joint Com- Targeted solutions mission and the American College of Sur- The participants identified 34 variables that Sgeons (ACS) on a 2-year project to re- increased SSI risk including patient characteristics, duce colorectal surgical site infections (SSIs) have surgical procedure, antibiotic administration, peri- saved more than $3.7 million by avoiding an operative processes, and measurement challenges. estimated 135 SSIs, the commission announced in Among targeted solutions for reducing super- November 2012. ficial incisional SSIs were: The commission is pilot testing the approach • standardizing preop instructions for skin used in the project with the aim of rolling out tar- cleansing geted solutions for all accredited hospitals in 2013. Joint Commission President Mark Chassin, • establishing specific criteria for wound man- MD, FACP, said colorectal surgery was chosen as agement. a focus because it’s a common major surgery with Solutions for reducing all types of colorectal a significant rate of complications, particularly SSIs were: SSIs. Also, complication rates vary widely, sug- • warming patients to maintain temperature gesting there is room to improve. throughout the surgical episode Through the project, led by the Joint Commis- • weight-based antibiotic dosing. sion’s Center for Transforming Healthcare, the There were 2 interventions all 7 hospitals participating hospitals: agreed on: • reduced their rate of superficial incisional • standardizing patient instructions on use of colorectal SSIs by 45% and reduced colorectal preop skin cleansing with wipes containing SSIs overall by 32%. chlorhexidine gluconate (CHG) • decreased the average stay for patients with • changing to clean gloves, gowns, supplies, and any type of colorectal SSI from 15 days to 13 instruments for the skin closure. days, compared to an average 8-day stay for patients with no SSIs. ‘No magic bullet’ Data-driven process At Cedars-Sinai, the surgeon champion, Shirin Towfigh, MD, FACS, worked with a multidisci- Participating hospitals followed a data-driv- plinary team of surgeons, nurses, performance im- en process using surgical outcomes data from provement specialists, and others to analyze risk fac- the ACS National Surgical Quality Improvement tors of the hospital’s surgical population and develop Project (NSQIP) to pinpoint specific risk factors interventions. In all, 46 surgeons were involved. for their patients and to develop targeted inter- “We knew there was no magic bullet to pre- ventions to reduce their colorectal SSI rates. vent all SSI,” she says. She met with each surgeon, Dr Chassin emphasized the importance of each including the 10 colorectal surgeons, to see what hospital identifying the risk factors of its own was feasible to change in their practices to im- patient population and developing interventions prove quality. targeted to those risk factors. “We tried to make it as simple and easy as pos- “There is no one-size-fits-all way to prevent SSIs,” sible and not to impinge on the independence of he said. “We have learned that you have to use the surgeon’s practice,” she says. sophisticated tools like rapid process improvement, The major interventions are summarized on a including Lean Six Sigma and change management, one-page sheet (illustration). to find out exactly how poor outcomes occur.” Dr Towfigh says 2 factors were key in achiev- Two hospitals represented on a Joint Commis- ing the SSI reductions: sion press call achieved a sustained reduction of • having a surgeon champion rather than an at least 50% in their colorectal SSI rates. Cedars- administrator as the project leader Sinai Medical Center in Los Angeles saw its colorectal SSI rate fall from 15.5% to 5.5% during • making sure the interventions were evidence- the 2 1/2 year project and decline to less than 5% based. since July 2012. The Mayo Clinic, Rochester, Min- Interventions were planned so as not to inter- nesota, reduced its rate from 9.8% to 4%. fere with efficiency.

Patient Safety in the OR The OR Management Series 91 Source, Cedars-Sinai Medical Center, reprinted with permission.

For example, for the skin closure, the OR At the Mayo Clinic, Rochester, Minnesota, staff arranged to change to clean supplies and interventions once adopted are embedded in instruments as seamlessly as possible by having patient care “so they are part of our system when- the items available in the room. Rather than ever possible,” said Jenna Lovely, PharmD, surgi- having a separate closure tray, closing instru- cal pharmacotherapy manager. ments and supplies are set aside at the begin- An example is patients’ body mass index ning of the case. (BMI), which emerged as an SSI risk factor in In another change, Cedars-Sinai converted the Mayo data set. An electronic trigger now from povidone-iodine to alcohol-chlorhexidine automatically identifies patients with a BMI gluconate (CHG) for surgical skin antisepsis, first over 30. for colorectal cases and then for other specialties “We have moved from this being a QI project and procedures. However, patients with colos- to being the way we work,” Lovely said. ❖ tomy stomas that are not being reversed are still prepped with povidone-iodine. —Pat Patterson Surgeons were informed the change would be made, and then povidone-iodine for surgical For more about the colorectal SSI prevention project site antisepsis was simply removed from the go to www.centerfortransforminghealthcare.org/proj- supply stock, Dr Towfigh says. When nurses ects/detail.aspx?Project=4 expressed concern about pushback from some surgeons, Dr Towfigh told them to refer the This article originally appeared in OR Manager, surgeons to her, and she would review the evidence with them. January 2013;29:1, 6-7.

92 The OR Management Series Patient Safety in the OR Have you taken steps to avoid the abuse of IUSS?

have heard the following statement from OR AAMI and AORN recommend using rigid personnel: “We use rigid sterilization contain- containers intended for IUSS cycles to protect Iers and run a 270-275ºF (132-135ºC) prevacu- instruments during aseptic transfer to the sterile um steam sterilization process in our OR. So we field. Processing unwrapped items is not recom- no longer use IUSS.” mended, because they are wet and could become contaminated during the transfer process. Is that an IUSS cycle? So the answer to the question, “Is process- IUSS, or immediate-use steam sterilization, ing instruments in a rigid sterilization container was formerly known as flash sterilization. at 270-275ºF (132-135ºC) in a prevacuum steam This article discusses the what, when, and how sterilization process considered IUSS?,” is yes, if of IUSS along with risks, the Joint Commission there is no dry time, and the items are wet at the perspective, and how to minimize use of IUSS. end of the cycle. What is IUSS? When to use IUSS The Multi-society Immediate-Use Steam Ster- AORN states IUSS “should be used only when ilization statement issued in 2011 broadly defines there is insufficient time to process by the pre- “immediate use” as the shortest possible time be- ferred wrapped or containerized method intend- tween a sterilized item’s removal from the steril- ed for terminal sterilization.” IUSS “should not izer and its aseptic transfer to the sterile field. The be used as a substitute for sufficient instrument sterilized item is: inventory.” • used during the procedure for which it was AORN, AAMI, and the Centers for Disease sterilized Control and Prevention agree that IUSS should • used in a manner that minimizes its exposure not be used to sterilize implants. to air and other environmental contaminants How to use IUSS • not stored for future use Here are the steps to keep in mind: • not held from one case to another. • Medical devices processed by IUSS should be The standard, Comprehensive Guide to cleaned, packaged, and sterilized according to Steam Sterilization and Sterility Assurance in the manufacturer’s IFU. Health Care Facilities (ST79) from the Asso- • Cleaning should be performed in an area that ciation for the Advancement of Medical Instru- has the equipment (eg, sinks and mechanical mentation (AAMI), in section 2.61 defines IUSS and/or ultrasonic washers), cleaning agents, as a “process designed for the cleaning, steam tools (eg, brushes), and water quality needed sterilization, and delivery of patient care items to follow the medical device manufacturer’s for immediate use.” AAMI ST79 also states, IFU. “Since drying time is not usually part of a pre- programmed cycle for immediate-use, the items • If the OR processing area does not have the processed are assumed to be wet at the conclu- appropriate setup, devices should be sent to sion of the cycle.” the sterile processing department (SPD) for cleaning, packaging, and sterilization. IUSS cycles • Packaging material should be that recom- An IUSS cycle can be either a gravity or dy- mended by the device manufacturer’s IFU and namic-air removal (eg, prevacuum or steam-flush should provide protection for aseptic presenta- pressure-pulse) cycle run at 270-275ºF (132-135ºC) tion. Unwrapped trays are not recommended. for the time recommended by the device manu- • The sterilization cycle, exposure time, tempera- facturer’s written instructions for use (IFU). This ture, and drying times (if recommended) should includes extended cycles if required. What makes be followed. It is no longer acceptable to run a 3- IUSS different from terminal sterilization is that or 10-minute 270-275ºF (132-135ºC) gravity cycle there is no dry time. That is why items must be for IUSS unless those cycles are recommended used immediately. by the device manufacturer’s IFU.

Patient Safety in the OR The OR Management Series 93 based on the data. If surveyors don’t find that, Why is immediate use they may cite the organization under the perfor- sterilization being used? mance improvement standards.” Data to collect routinely and to aggregate More than 80% of the time in a study at monthly, Rosing advises, includes: one large hospital, immediate-use steam • the number of IUSS episodes attributed to lack sterilization (IUSS) was used for reasons of instruments other than its recommended purpose—in- • the evaluation completed by OR leadership traoperative contamination, such as when and submitted to the infection control commit- an instrument is dropped. The most com- tee for its evaluation. mon reasons documented were: The committee should present its data on the • operating room turnover number of IUSS episodes that were due to a lack • receipt of an unsterile instrument of instruments to the hospital’s finance depart- • intraoperative contamination ment to justify the need to buy more instruments. • contamination from breaches in packaging Traceable to the patient • a one-of-a-kind instrument. At the 2011 meeting of the International As- sociation of Healthcare Central Service Materiel —Zuckerman S, Parikh R, Moore D C, et Management (IAHCSMM), a Joint Commission al. Am J Infect Cont. 2012:40:866-871. surveyor said that the Joint Commission is also interested to see that any devices, including implants, processed by IUSS be traceable to the • The same sterilization cycle and parameters patients on which they are used or implanted. used in SPD need to be used in the OR. This AAMI ST79 Section 10.3 states: “IUSS of im- may require the use of an extended cycle, eg, plantable devices is not recommended; however, 270-275ºF (132-135ºC) gravity cycle for 30 min- if it is unavoidable, full traceability to the patient utes, or a 270-275ºF (132-135ºC) dynamic-air should be maintained.” Traceability is important removal cycle for 10 minutes. because of the serious consequences of infections • The sterilization cycle should be document- related to implants. ed with physical monitors and chemical and Releasing implants biologic indicators (BIs) and the results docu- AAMI ST79 also states that “releasing im- mented along with the name of the patient. plants before the BI results are known is unac- AORN states that because these devices are ceptable and should be the exception, not the hot and wet, care should be taken to transport rule.” AAMI ST79 has 2 forms in Annex L that the devices to the point of use “in a manner that can be used to track documentation of prema- minimizes the risk of contamination of the item ture release of implants. One is an Implantable and injury to personnel.” Devices Load Record, and the other is an Excep- Take care to document tion Form for Premature Release of Implantable Device/Tray that includes documenting why A recent study by Zuckerman et al, conducted premature release of the implant was needed in Vanderbilt University Hospital’s main OR, and what could have prevented this premature identified potential lapses in practice related to release. IUSS, including incomplete documentation of: Joint Commission surveyors will check these • use of chemical and BIs (ie, used in each load) forms to see how many implants are released • peak temperature before the BI is available. They will expect to see a • cycle time Department of Surgery policy that includes mul- • description of specific instruments sterilized. tidisciplinary input to address who can authorize early release of implants. The Joint Commission The authors encourage “institutions to strictly suggests this be a surgeon. assess the rationale for IUSS and documentation of core IUSS components. Only through sound How to minimize IUSS documentation can practices be monitored and Be sure you and your superiors are aware of quality improved.” the Joint Commission’s National Patient Safety Joint Commission perspective Goal 07.05.01, in particular EP 4, which states: “As part of the effort to reduce surgical site infections, John Rosing discussed observations about conduct periodic risk assessments for surgical IUSS from Joint Commission surveys in the Oc- site infections in a time frame determined by the tober 2012 OR Manager. He noted: “Joint Com- hospital.” This could be interpreted to apply to mission surveyors won’t cite an organization for IUSS. Conduct a risk assessment to determine sterilizing instruments for immediate use. Rather, why the facility is using IUSS and determine how they will check that data is being collected on to eliminate all reasons except for intraoperative instances when immediate-use sterilization is contamination. used and then check to see if action is being taken

94 The OR Management Series Patient Safety in the OR The data collected, as suggested above, will dation X. Perioperative Standards and Recom- assist in this risk assessment. mended Practices. Denver, CO: AORN, 2013. www.aorn.org Policy on loaners Centers for Disease Control. Guideline for Disinfec- As a result of the risk assessment, your facility tion and Sterilization in Healthcare Facilities, may determine that the policy and procedure for 2008. www.cdc.gov/hicpac/pubs.html loaner instruments needs to be updated and/or enforced. International Association of Healthcare Central Service Materiel Management. Position Paper on Communication is key. When loaner sets are the Management of Loaner Instrumentation and used, the correct instrumentation needs to arrive Sample Policy & Procedure for Loaner Instru- at least 2 business days before the scheduled case mentation. http://iahcsmm.org/CurrentIssues/ to facilitate proper cleaning, sterilization, and Loaner_Instrumentation_Position_Paper_Sam- quarantine of implants until the BI results are neg- ple_Policy.html ative. The IAHCSMM position paper and sample Joint Commission. 2012 Hospital Accreditation policy are invaluable tools to use in this process. Standards. Oakbrook Terrace, IL: Joint Commis- Management teams from the OR, sterile pro- sion, 2012. www.jointcommission.org cessing, infection prevention, and risk management need to work together to develop policies Mathias J. Tips, lessons from a recent Joint Commis- and procedures to ensure IUSS is not performed sion survey. OR Manager. 2012:28(10):18-22. for convenience. Abuse of IUSS has the potential Multi-society Immediate Use Sterilization position to increase risk for development of SSI. ❖ statement. AAMI and others. www.aami.org/ —Martha Young, MS, CSPDT publications/standards/st79.html President, Martha L. Young, LLC, providing Young M. How to add more teeth to your loaner set SAVVY Sterilization Solutions for Healthcare- policy. OR Manager. 2012:28(6):24-25. Woodbury, Minnesota Young M. Preparing for a Joint Commission Survey. 3M Sterile U Sterilization Assurance Continuing Martha Young is an independent consultant Education. March 2012. http://solutions.3m.com/ with long experience in medical device steriliza- wps/portal/3M/en_US/sterilization/3MSterileU/ Home/InServiceArticles/ tion and disinfection. Young M. Putting teeth in your loaner policy and References procedure. OR Manager. 2011;27(9):22-27. Association for the Advancement of Medical In- Zuckerman S, Parikh R, Moore D C, et al. An strumentation. Comprehensive guide to steam evaluation of immediate-use steam sterilization sterilization and sterility assurance in health care practices in adult knee and hip arthroplasty pro- facilities. ANSI/AAMI ST79:2010 & A1:2010 & cedures. Am J Infect Cont. 2012: 40:866-871. A2:2011 & A3:2012. www.aami.org This article originally appeared in OR Manager, AORN. Recommended practices for sterilization in the perioperative practice setting. Recommen- March 2013;29:22-24.

Patient Safety in the OR The OR Management Series 95 Hospitals share data to prevent colorectal SSIs

hy does our hospital have a higher rate Though the reasons why the 5 measures im- of venous thromboembolism (VTE) proved so dramatically was not readily appar- W than others in our state? How are oth- ent, one reason might be willingness to share ers preventing surgical site infections (SSIs) after data and compare notes candidly, says Joseph B. colorectal surgery? What’s behind our urinary Cofer, MD, FACS, head of TSQC and professor of tract infection (UTI) rate? surgery at the University of Tennessee College of Hospitals in Tennessee are openly discussing Medicine, Chattanooga. issues like these through the Tennessee Surgi- A more recent report, as yet unpublished, cal Quality Collaborative (TSQC), a 21-member shows improvement has been sustained for 4 of 5 state-level group focused on improving surgical outcomes in the initial study. outcomes. “This has been a gradual process over 5 years,” he told OR Manager. “I think we’re going to see Hospitals can reduce complications sustained improvement.” Reducing surgical complications is a high pri- Surgeons are willing to participate because the ority as organizations seek to improve care and collaborative uses NSQIP, which is scientifically lower costs. Complications not only cause pain validated, says Dr Cofer, noting that “when you and suffering but increasingly are tied to reim- show surgeons the data, they try to get better.” bursement from Medicare and private payers. Developed by surgeons, NSQIP focuses on 30- The Tennessee project is showing that hos- day outcomes and uses data from patients’ charts, pitals can reduce complication rates by sharing not claims. The data is risk adjusted, case-mix data, comparing results, and exchanging ideas on adjusted, and audited. improving care. The collaborative’s funding supports about TSQC is a partnership of the Tennessee Hospi- half of a hospital’s $120,000 annual cost for joining tal Association (THA) and the state chapter of the NSQIP. That includes membership plus a full- American College of Surgeons (ACS), with fund- time surgical clinical reviewer (SCR), a require- ing from the Blue Cross Blue Shield of Tennessee ment. The reviewer collects data on 40 surgical Health Foundation. All participants are enrolled cases in an 8-day cycle and enters it in the NSQIP in the ACS National Surgical Quality Improve- data base. Each hospital must also appoint an ment Program (ACS NSQIP). engaged surgeon champion. Similar collaboratives are underway in 9 states and at least 7 health systems, according to ACS, Digging into data with Tennessee and Florida having the largest. The TSQC hospitals meet quarterly and share The Tennessee collaborative began in 2007. A data in a blinded fashion. Though initial meetings report of results from 2009 through 2010 when were tentative, Dr Cofer says trust has developed. there were 10 participants showed significant im- “The members dig into the data and openly provements in 5 of 21 types of complications for share with each other where the opportunities general and vascular surgery: are,” adds Chris Clarke, BSN, RN, THA’s senior • acute renal failure vice president of clinical services, who manages • graft/prosthesis/flap failure the project. A participant might say, for example, “Our in- • ventilator time >48 hours fection rate was high last year. What do you think • superficial SSI we should be doing?” • wound disruption. Or a report might show Hospitals B and G Three outcomes got worse: deep vein thrombo- have the lowest UTI rates. They volunteer to dis- sis, pneumonia, and UTI. The report was published cuss their prevention efforts. in the Journal of the American College of Surgeons. A colorectal SSI bundle Net costs avoided were estimated at $2.2 mil- TSQC hospitals have agreed to trial a bundle lion per 10,000 cases. TSQC estimates overall sav- of interventions for preventing SSIs from colorec- ings of $8 million for that period based on annual tal surgery that goes beyond measures in the volumes.

96 The OR Management Series Patient Safety in the OR Making a difference in care using NSQIP data

Hospitals that participate in adds Kay Loyd, BSN, RN, CEN, committee thought one reason the American College of Sur- performance improvement spe- might be the use of nonsteroidal geons National Surgical Quality cialist. Some surgeons also use anti-inflammatory agents for Improvement Program (ACS warmed IV fluids. postop pain control. Certain of NSQIP) get validated, risk-ad- these agents carry a “black box” justed data on 30-day outcomes Supplemental oxygen warning from the Food and Drug for surgical patients. Goal: Administer high-flow oxygen Administration. But how do you involve front- (FiO2 at 80%) for the first 6 hours The physicians were alerted line staff so the data can make a postoperatively. and have become more conscious difference in patient care? Before this intervention was of NSAID use. At Baptist Memorial Hospital- added to the postop orders, Loyd Within 6 months, the incidence Memphis, NSQIP data is shared requested a review by pulmon- of renal failure returned to an ac- with surgeons and nurses who ologists at the request of risk man- ceptable range. are engaged in continuously agement. Four pulmonologists “That was a great example of improving care. The hospital is a reviewed it and saw no problem, how a multidisciplinary team member of the Tennessee Surgi- she says. Anesthesia providers let works,” she says. cal Quality Collaborative (TSQC) the surgeons know if a patient is (related article). not a good candidate. Sharing with surgeons An example is the collabora- Baptist Memorial’s surgeon tive’s colon bundle for prevent- Prophylactic antibiotics champion, Stephen Behrman, ing surgical site infections Goal: Select the appropriate antibiotic. MD, FACS, has asked that the (SSIs). At Baptist Memorial, the For the colon bundle, as with NSQIP 30-day outcomes by bundle’s interventions are posted the SCIP measure, antibiotics are surgeon be posted in the phy- above the scrub sinks where sur- to be given consistently with cur- sicians’ lounge with names geons and staff can review it. rent guidelines for colorectal sur- blinded. Surgeons can identify Here are steps the hospital is gery. (SCIP is the Surgical Care their own results by their ID taking to implement the bundle’s Improvement Project.) numbers and compare them 4 interventions. with peers. Postoperative glucose “Dr Behrman can sit down Maintaining Goal: Maintain patients’ blood glu- with a surgeon if there’s a normothermia cose level <200 mg/dL on the day of problem to see what can be Goal: Maintain temperature for surgery (postop day zero). done to improve their out- colon surgery patients to be at least Patients’ blood glucose is comes,” Loyd says. 36ºC during the procedure. checked in the preoperative area She thinks the surgeons’ All patients are prewarmed and again in the postanesthesia response to NSQIP has been prior to surgery regardless of care unit. more positive than it is to SCIP. temperature using a warming “The nurses know the goal She notes that more patients gown (Bair Paws). Forced-air is less than 200,” Loyd says. “If are audited, and the data is warming devices (Bair Hugger) patients are diabetic, they are more specific. are used during surgery. often checked intraoperatively as “SCIP looks at patients only “There is a real focus on nor- well.” through postop day 2 or 3,” mothermia for long procedures she says. “NSQIP looks at out- and for patients who present Making a difference comes at up to 30 days postop. with comorbidities,” says Daryl An example of how the data So we are getting a realistic Miller, BS, RN, director of surgi- is applied is renal failure. Re- view of how our patients do cal services. viewing the results, a multidis- long term.” “If nurses see a patient’s ciplinary group noticed renal temperature is dropping, they failure outcomes were somewhat can turn up the Bair Hugger,” elevated. The pharmacist on the —Pat Patterson

Patient Safety in the OR The OR Management Series 97 Surgical Care Improvement Project (SCIP). The of the participants. We were doing something interventions are based on information NSQIP significantly different,” she says. provided on SSI prevention. A team led by the surgeon champion, who “We looked at all of the promising practices, is chair of the endovascular team, narrowed the not just those that have Level 1 evidence,” Clarke problem to peripherally inserted central catheter says. “These are things we identified as enhanced (PICC) lines. opportunities beyond the standard SSI reduction The VTE rate decreased after 2 steps were strategies that would be worth trialing.” taken: The surgeon champions were asked to trial the • changing from using 3-lumen to 2-lumen PICC bundle with their own patients and then to spread lines, unless there is a specific need it among peers. The SCRs will track compliance. • providing the nursing staff with further educa- The bundle includes: tion on site selection for PICC lines. • redosing the antibiotic for surgery lasting more “It is highly motivating when you have data, than 3 1/2 hours can apply it, and realize it makes things better for • adjusting the antibiotic dose for morbidly patients,” Cole-Jenkins says. obese patients “This is data, but it’s also people’s lives. The • tracking patients’ blood glucose levels on the impact of having an SSI is possibly life-altering. day of surgery regardless of whether they are Whatever we can do to keep that from happening diabetic is what we need to be doing.” • monitoring patients’ temperatures continuous- Sharing with surgeons ly and keeping them warm throughout the case Some organizations share individual NSQIP • administering supplemental oxygen for 6 data with the surgeons. hours postoperatively. Dr Cofer provides individual outcomes data “Our data in Tennessee suggests there is a cor- with faculty surgeons twice a year, showing them relation between high blood glucose and SSIs for how they compare with the group with identities colorectal surgery,” Clarke notes. blinded. On normothermia, TSQC goes beyond docu- After reviewing their reports, surgeons may menting that a warming device was applied come to him seeking more information. For ex- to include monitoring patients’ temperatures ample, they might want to know why their throughout the case. The reason is that a patient’s mortality rate was higher than their peers’ for the temperature can vary before, during, and after same procedure. The SCR can print a report that surgery, notes Cheri Cole-Jenkins, RNC, MPH, provides the details. manager of the quality department at 300-bed “We now have data that we didn’t have 5 or Parkwest Medical Center in Knoxville, Tennessee, 6 years ago, and it’s data we can believe in,” Dr a TSQC participant. Cofer says.❖ “We’re challenging ourselves to see that the —Pat Patterson [warming device] is doing what it is intended to do, which is to maintain temperature,” she says. More about ACS NSQIP is at www.acsnsqip.org. For the surgical skin prep, most TSQC members already use an alcohol-chlorhexidine gluconate solution, which studies have found is associ- References ated with a lower SSI rate than povidone-iodine. Darouiche R O, Wall M J, Kamal M F, et al. Making a difference for VTEs Chlorhexidine-alcohol versus povidone-iodine for surgical-site antisepsis. N Engl J Med. Cole-Jenkins says data from TSQC has helped 2010;362:18-26. her hospital to highlight areas where it has strong results and other areas where there are challenges. Guillamondegui O D, Gunter O L, Hines L, et al. Using the National Surgical Quality Improve- “We found we were a low outlier—a good ment Program and the Tennessee Surgical Qual- thing—for pneumonia, particularly given that our ity Collaborative to improve surgical outcomes. J population is fairly high in smoking,” says Cole- Am Coll Surg. 2012;214:709-714. Jenkins. She attributes the result to the hospitalist program, an aggressive pulmonary group, and strong respiratory therapists. With VTE, however, they found challenges. “Having the hard evidence [from TSQC] enabled This article originally appeared in OR Manager, us to recognize we were out of line with the rest January 2013;29:11-13.

98 The OR Management Series Patient Safety in the OR New AORN recommendations focus on infection prevention, patient safety

ORN leaders’ efforts over the past few A change in the recommendation about sterile years have led to evidence-rated recom- fields generated audible surprise during the pre- Amendations for some of the 2013 Periop- sentation by lead author Sharon A. Van Wicklin, erative Standards and Recommended Practices MSN, RN, CRNFA, CPSN, PLNC, CNOR, a peri- (RPs), representing “landmark progress in the operative nurse specialist with AORN. evolution of recommended practices,” accord- AORN has had a long-standing recommenda- ing to Ramona Conner, MSN, RN, CNOR, tion that, once created, the sterile field should manager of the standards and recommended not be left unattended until the procedure has practices. Conner introduced speakers who been completed, and this has not changed. The gave updates on the RPs for prevention of new recommendation is that if there is an un- transmissible infections, sterile technique, and anticipated delay or during periods of increased sharps safety at the AORN Congress in March activity, such as when the patient is being brought 2013 in San Diego. into the room, the sterile field that will not be Here are highlights of the session. For com- immediately used may be covered with a sterile plete language, see the 2013 Perioperative Stan- drape (illustration). dards and Recommended Practices. This recommendation shows how evidence can change practice; recent research demonstrates Sterile technique that covering the sterile table “may actually help AORN’s Recommended Practices for Sterile to preserve the sterility of the field and to prevent Technique have replaced the RP for Maintaining a environmental and microbial contamination,” Sterile Field and now include the RP for Selection Van Wicklin said. For example, a study of 41 and Use of Surgical Gowns and Drapes. total joint replacements showed that covering the instruments during periods of increased activity shortened overall exposure time and led to a 28- fold reduction of instrument contamination. Sterile fields should be covered in a manner that does not allow the portion of the cover that falls below the sterile field to come above the sterile field. AORN also recommends that organizations work with their infection prevention personnel to develop a standardized procedure for covering the sterile field. According to Van Wicklin, covered sterile fields should be monitored, and policies about monitoring, uncovering the field, and the length of time the sterile field is covered should be determined by each individual facility, ideally with the help of an infection preventionist. Gloves One new recommendation is to use a closed as- The first drape is placed with the cuff at the halfway point. sisted gloving method; the open assisted gloving The second drape is placed from the opposite side and com- method should be used only when closed assisted pletely covers the cuff of the first drape. gloving is not possible or practical, according to Illustration by Colleen Ladny and Kurt Jones. Van Wicklin. This is not a change but rather a Reprinted with permission from Perioperative Standards clarification based on the evidence. and Recommended Practices. Copyright © 2013, AORN, The double-gloving recommendation, also a Inc, 2170 S. Parker Road, Suite 400, Denver, CO 80231. part of the RP for prevention of transmissible in- All rights reserved. fections and the RP for sharps safety, was added

Patient Safety in the OR The OR Management Series 99 Reprinted with permission from Perioperative Standards and Recommended Practices. Copyright © 2013, AORN, Inc, 2170 S. Parker Road, Suite 400, Denver, CO 80231. All rights reserved.

100 The OR Management Series Patient Safety in the OR to the sterile technique RP because of its impor- Sharps safety tance as a means to prevent surgical site infection The Recommended Practice for Sharps Safety, (SSI), she noted. The recommendation is to double previously a guidance statement with suggested glove during procedures when there is potential strategies for preventing injuries, is now a new RP for exposure to blood, body fluids, or other poten- expected to be released to e-subscribers in June tially infectious materials. 2013 and will be published in the 2014 Periopera- “There may be rare occasions when double- tive Standards and Recommended Practices book, gloving is not absolutely necessary, but the according to lead author Mary Ogg, MSN, RN, amount and quality of the evidence that sup- CNOR, a perioperative specialist at AORN. ports the recommendation for double-gloving There have been 132 documented cases of pa- is very clear,” she said, citing support from the tient to health care worker transmission of HBV, Centers for Disease Control and Prevention HIV, and HCV, she noted. The RPs are based on (CDC), the American College of Surgeons, and regulations from the Occupational Safety and the American Academy of Orthopaedic Sur- Health Administration. geons (AAOS). In addition, a meta-analysis of 5 This RP recommends the following: trials found that significantly more perforations • Safety-engineered devices (eg, safety scalpels, were detected when a perforation indicator needleless IV connectors). system (ie, wearing a colored pair of surgical gloves underneath a standard pair of surgical • Blunt suture needles unless contraindicated. gloves) was used than when it was not (77% vs A review by the Cochrane Collaboration 21%, respectively). (highest level of evidence) found that blunt The RP includes specific times for changing suture needles reduced glove perforations gloves: by 50% and lowered disease transmission. • after each patient procedure These have been rated as acceptable in 5 of 6 studies. • after touching the surgical helmet system, ie, hoods and visors (new) • Alternative wound closure devices. • after adjusting the eyepieces on an operating • A neutral zone or hands-free technique for microscope (new) passing sharps, blades, and needles. • after direct contact with methyl methacrylate • Double-gloving. • when gloves begin to swell on the hands • A glove perforation indicator system. • when a perforation is suspected or actually occurs Transmissible infections • every 90-150 minutes (new). Perioperative actions to prevent transmission Several studies have shown a positive correla- of health care-associated infections (HAIs) are in- tion between the rate of glove perforation and cluded as part of a new section of the Prevention the length of time that they’re worn. AAOS rec- of Transmissible Infections RP, according to Lisa ommends changing outer gloves at least every 2 Spruce, DNP, RN, ACNS, ACNP, ANP, CNOR, hours. Recognizing that gloves cannot be changed director of evidence-based perioperative practice at a precise time during a procedure, AORN recom- for AORN and lead author of this RP. mends a span of time during which gloves should There are 500,000 surgical site infections be changed (ie, every 90 to 150 minutes). But the per year; SSIs make up 1.7 million of all HAIs, published literature does not provide an answer on based on statistics compiled by the CDC. SSIs whether to change 1 or both gloves, Van Wicklin are the second most common type of HAI after pointed out. urinary tract infections. Actions to prevent SSIs include: Other sterile practices • maintain a clean environment and surgical attire • Based on studies showing high levels of con- • use skin antisepsis tamination of the C-arm drape, another new recommendation is to consider the upper por- • use good hand hygiene tion of the C-arm drape contaminated. • minimize OR traffic • A recommendation is added to use the isola- • verify adequate sterilization. tion technique during bowel resection and The research on the merits of decoloniza- resection of metastatic tumors. This can be tion of the patient is conflicting, especially accomplished with a single or dual setup, and on Staphylococcus aureus in the nasal pharynx, instructions are included in the RP. Spruce said. Physicians may or may not elect • Minimizing the number of personnel in the to do this, so it’s important to keep an eye on OR is not a new recommendation but is em- developments. phasized in this RP, Van Wicklin said. Studies The CDC recently issued an alert on car- have documented the relationship between bapenem-resistant Enterobacteriaceae. A tool kit increased numbers of personnel and higher available at www.cdc.gov/hai/organisms/cre/ levels of particulates in the environment. cre-toolkit/index.html provides guidelines for preventing this HAI.

Patient Safety in the OR The OR Management Series 101 A new recommendation involving prevention Accrediting (eg, Joint Commission) and regula- of central line-associated bloodstream infections tory agencies (eg, the Centers for Medicare and (CLABSIs) is included because clinicians put in Medicaid Services) require all facilities to have an lines in the OR, Spruce said. They should use the infection control plan, so “this should be a very same technique used to insert these lines at the easy RP for you to implement,” Spruce said. ❖ bedside. The CDC recommends use of a maximal —Elizabeth Wood sterile barrier (ie, hair cover, mask, sterile gown, gloves, full-body drape). References She encouraged clinicians to follow CDC Chosky S A, Modha D, Taylor G J. Optimisation of guidelines for prevention of catheter-associated ultraclean air. The role of instrument prepara- urinary tract infections (CAUTIs). Use catheters tion. J Bone Joint Surg Br. 1996;78(5):835-837. only as indicated, not just for convenience; docu- Parantainen A, Verbeek J H, Lavoie M C, Pahwa M. ment the date and time of insertion; and remove Blunt versus sharp suture needles for preventing them as soon as possible after surgery, preferably percutaneous exposure incidents in surgical staff. within 24 hours. She emphasized that periop- Cochrane Database Syst Rev. 2011;11:CD009170. erative RNs should be educated and demonstrate Tanner J, Parkinson H. Double gloving to reduce competency on catheter insertion. surgical cross-infection. Cochrane Database Syst A new feature is a useful surgical wound clas- Rev. 2009;3:CD003087; doi:10.1002/14651858. sification decision tree that was reviewed by the CD003087.pub2. CDC (chart). Also new is a quick reference table for care and transportation of patients who are on This article originally appeared in OR Manager, contact, airborne, or droplet precautions. June 2013;29:20-23.

102 The OR Management Series Patient Safety in the OR ‘Operation Zero’ targets surgical site infections

surgical site infection (SSI) prevention long sleeves or not bringing items such as brief- “bundle” is helping OR teams at Maine cases into the OR, though these are based on AMedical Center (MMC) in Portland to fur- infection prevention principles. ther a strategic goal of preventing SSIs. Known as (AORN’s Recommended Practices for surgical Operation Zero, or “Op-Z,” the initiative is led by attire advise wearing a long-sleeved jacket that is the chief of surgery, Brad Cushing, MD, with in- snapped closed. The rationale is that the sleeves spiration from a family whose healthy 85-year-old help to contain skin squames shed from bare father died from an SSI after a total hip replace- arms, and a closed jacket prevents the edges of the ment at MMC. jacket from contaminating the skin prep area or Op-Z includes, in addition to the SSI bundle, sterile field. AORN also recommends not bring- notification of the entire perioperative team when ing items such as backpacks and briefcases into a patient they cared for develops an SSI. the OR because they are made of porous material The SSI bundle, known as the Op-Z Checklist, that can harbor dust and pathogens.) is posted on the wall in each OR (sidebar). Before each case, the OR team verifies that it has reviewed the Op-Z checklist. The bundle constitutes Op-Z Checklist one item on the presurgical checklist. The bundle for preventing surgical site The Op-Z prompt encourages everyone in the infections at Maine Medical Center: OR to look around and make sure their colleagues ■ All hair covered in OR, including are complying with the bundle’s elements, such as covering all hair and wearing long-sleeved facial hair. warm-up jackets, says Karen Dumond, MSN, RN, ■ Attire appropriate. All staff to wear CNOR, nursing director for the OR. hospital-provided, clean/laundered The bundle is not part of the time-out, she apparel in the OR. Hospital-provided notes. Instead, surgeons are simply encouraged cover jackets will be worn in the to say, “The team has reviewed the Op-Z Check- presence of open sterile supplies. list,” prompting the team to pause and check for Exception is scrubbed personnel. compliance. Rings, bracelets, and watches are either Developing the bundle removed or contained. The bundle was developed by groups of peri- ■ No unnecessary items are brought into operative team members who suggested items the OR. That includes briefcases or any they thought should be included. There were other items not needed for the case. groups for the preoperative, intraoperative, and ■ postoperative periods as well as for the ambula- The sterility of all operative materials tory surgery unit and postanesthesia care. There ensured. also were groups for colon and vascular surgery. ■ Appropriate skin prep used in proper Each group reviewed the literature, came up fashion. with 3 priorities, and sent those to the Surgical ■ Measures to ensure normothermia are Services SSI Reduction Steering Committee. The committee reviewed the items and selected the in place, if appropriate. initial bundle. ■ Blood sugar control plan instituted, if Reaching consensus took a lot of give and take. appropriate. “Everyone wanted to see the evidence,” Du- ■ Redosing antibiotic schedule mond says. There may not be published studies determined and timer set, if needed. specifically related to practices such as wearing

Patient Safety in the OR The OR Management Series 103 “Almost every specialty was involved. It was very powerful,” says Dumond. The family of the 85-year-old patient, George H. Ellis, PhD, was present. The patient’s son-in-law, Stephen Hudspeth, JD, gave a moving presentation, emphasizing that behind every patient with an SSI is a family. “I’m told you do 1,800 hip and knee replacements annually,” he told the audience. “I’m told that in the past 6 months, there have been zero infectious outcomes,” even though the usual infection rate nationally for a hip replacement is 1.5%. “That is 27 families over a year’s time who have you to thank for their continued ability to enjoy a loved one with them.” He asked the audience to imagine those 27 families assembled there and, behind them, hundreds more who represented their families and communities. After Ellis’s death 5 years ago, the family set up a fund at MMC specifically for the purpose of infection prevention, and the family checks in regularly for progress reports. Hudspeth congratulated the OR teams assembled for their work every day in preventing infections. Because of their work, he said, “These are families who don’t have to go through what we went through.” Many in the audience had tears in their eyes. A lighted marquee at the OR entrance reminds everyone Reinforcing practices of the focus on preventing surgical site infections. A bit of levity helped to reinforce infection prevention practices at the meeting. After a review of SSI statistics, the audi- Establishing a standard ence watched 2 humorous videos to help get the At MMC, the steering committee took the po- point across about the SSI bundle. The committee sition that it needed to establish a standard that had checked in advance with the patient’s family everyone would follow consistently. to make sure they wouldn’t see the humor as dis- “That makes people think about what they’re respectful, Dumond notes. doing and about other areas we need to look at,” One video illustrated the correct application says Dumond. of the surgical prep solutions. Using an inflatable Hair covering was an issue. doll, the surgeon applied the prep and set the “The goal is that the head covering has to be timer for 3 minutes to let it dry. He then took the clean and cover all hair,” she says. scalpel, made the “incision,” and the doll deflated. Skull caps weren’t eliminated, however, be- In the second skit, a mock orthopedic case, cause some surgeons who wear headlights said the team showed how to review the Op-Z line on the bouffant caps caused the light to slide around. the preop checklist. As they looked around, they Skull caps can be worn only by individuals whose realized that the anesthesia provider had to put hair is shaved close to the back of the head. a jacket on. The surgical technologist had a lock Compliance with jackets was difficult in the sum- of hair showing, and someone clipped it off in mer, Dumond notes, “but people seem to be doing humor. They then started the “case” using a kitch- it. It’s easier now that we are going into winter.” en knife and power tools brought from home. Kicking off Op-Z The skits went over very well, Dumond says. The Op-Z Checklist was rolled out in August Teams notified of SSIs 2011 with an all-hands meeting for surgeons, Though surgeons have always been notified of nurses, and anesthesia providers held in the SSIs, as part of Op-Z, the entire team that was in hospital’s auditorium. This was not a routine the OR during that case is now notified, including meeting. As the audience entered, scrolling on the the surgeon, anesthesia provider, nurse, and ST, screen was a list of all of the SSIs at MMC, listing as well as the admitting unit and postanesthesia the procedures but not patient names. care staff.

104 The OR Management Series Patient Safety in the OR “It is not meant to be punitive but to raise surgical checklist, the reaction at first was, “not awareness,” Dumond says. “It helps to get people one more thing,” recalls Dumond, admitting she out of thinking, ‘That doesn’t happen to me.’” agreed. Then the nurses began thinking about how they could make it work. Checking on compliance Changing culture is hard, she comments. To ensure adherence with the SSI bundle, “The staff may wonder, ‘Is this just the flavor teams of anesthesia providers, surgeons, and staff of the month? If I wait, will it go away?’ To make will be conducting observations, as they did to it a culture change, you have to get the message ensure compliance with the time-out. across that this is not going away.” ❖ “We have more work to do,” Dumond says, —Pat Patterson noting there is progress, such as more hair being covered. Baskets have been hung on the wall out- Reference side the ORs to hold belongings like briefcases. AORN. Recommended practices for surgical attire. She credits Dr Cushing for his leadership Perioperative Standards and Recommended Practices. in building the momentum behind Op-Z. “He Denver, CO: AORN, 2011. www.aorn.org is very innovative. He really puts thought and work into this,” she says. “He asks, ‘How can we do this so it will have an impact?’” When Dr Cushing first proposed to the nurses This article originally appeared in OR Manager, having the SSI bundle as another line on the January 2012;28:17-19.

Patient Safety in the OR The OR Management Series 105 Preventing SSIs: Keys to solutions lie with your front-line clinicians

ow will a surgical site infection (SSI) develop in the next patient who has colorec- 5-step plan to lower Htal surgery? What can we do to prevent it? colorectal SSIs These 2 questions helped a team at Johns Hop- kins Hospital in Baltimore to identify 6 interven- The 5-step surgical CUSP plan: tions that achieved a 33% reduction in SSIs after • Educate team members on the science of colon operations. safety, which includes an introductory The key was a patient safety program that em- talk addressing safety at a local level. powers front-line providers to develop solutions • Have team members complete a 2-ques- for preventing harm to patients. The surgical com- tion survey asking: prehensive unit-based safety program (CUSP), — How will an SSI develop in the next developed at Johns Hopkins, got its start in 2 sur- patient? gical ICUs in 2001. Results showed the program — What can we do to prevent an SSI? improved the safety culture and was linked with reduced lengths of stay, fewer medication errors, • Have a senior hospital executive partner and possibly lower nursing turnover. with surgical services to improve com- Johns Hopkins and others have adopted CUSP munication and educate leadership. The to aid in reducing central line-associated blood- executive attends CUSP meetings and stream infections, ventilator-associated pneumo- makes resources available to address nia, and mortality. safety concerns and assist with system- In a nationwide project, CUSP reduced blood- wide barriers. stream infections in ICUs by 40%, saving more • Teach team members to use a structured than 500 lives, the Agency for Healthcare Re- learning-from-defects tool. search and Quality (AHRQ) reports. • Have team members use tools, includ- Applying CUSP to SSIs ing checklists, to improve teamwork and Based on these experiences, Elizabeth C. Wick, communication. Teams review unit-level MD, FACS, a colorectal surgeon and assistant pro- SSI data monthly and develop initiatives fessor of surgery at Johns Hopkins, and her col- to improve teamwork, enhance commu- leagues decided to apply CUSP to colorectal SSIs. nication, and address identified hazards. “We came up with a surgical CUSP after an American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) and managed improvement projects; and a hospi- pilot we were participating in showed we had a tal executive who was committed to the project. colorectal wound infection rate of 30%,” Dr Wick “None of us had any experience with CUSP ex- told OR Manager. cept for the anesthesia representative, who had “The CUSP program is unique,” she adds, “be- experience in the ICU,” says Dr Wick. cause it focuses on the front-line providers who The leadership team met monthly. Also joining take care of patients day to day in the OR. It gives the team, which eventually totaled 36 members, them the power to identify and fix defects.” were nurses, certified registered nurse anesthe- A report on the project appeared in the Journal tists (CRNAs), surgical technologists (STs), and of the American College of Surgeons. anesthesiologists. The leadership team then de- AHRQ has funded a new national Surgical Unit- signed a 5-step plan to educate the team on the Based Safety Program, or SUSP, using the same ap- science of safety, complete the 2-question survey, proach. Hospitals can join for free (sidebar). and teach tools for improving teamwork and communication (sidebar). Launching the project For the colorectal surgery project, a CUSP Front-line clinicians key leadership team was formed that included “pro- The CUSP leadership team convened all front- vider champions” from surgery, nursing, and line providers, including STs, nurses, surgical res- anesthesia; a team coach who facilitated meetings idents, anesthesiologists, CRNAs, and surgeons.

106 The OR Management Series Patient Safety in the OR Six interventions to Standardizing the skin prep Perioperative nurses told the CUSP leadership prevent colorectal SSI team they thought both the prep solution and The interventions introduced by the CUSP technique should be standardized. The technique varied and was performed by team: both nurses and surgical residents. • standardization of skin preparation Prep solutions with either a chlorhexidine • administration of preoperative gluconate (CHG) or povidone-iodine solution chlorhexidine showers were used, and there was confusion about which • selective elimination of mechanical solution to use if the patient had an ostomy. Be- bowel preparation cause CHG is contraindicated for mucous mem- • warming of patients in the preanesthe- branes, povidone-iodine was used on patients sia area with ostomies. • adoption of enhanced sterile techniques Recent studies have found CHG to be supe- for bowel and skin portions of a case rior to povidone-iodine for preventing SSIs. A • addressing lapses in prophylactic anti- large multicenter prospective randomized trial by Darouiche et al found patients whose skin biotics. was prepped with a CHG-alcohol product had a significantly lower overall SSI rate than those They were given an introductory lecture on the prepped with povidone-iodine—9.5% vs 16.1%. science of safety covering these points: Two meta-analyses published in 2010 by Lee et al • Safety is part of the work system. and Noorani et al, found lower SSI rates when a CHG prep was used. • There are principles for designing safe processes (eg, learning from mistakes, standardizing Consensus protocol for prep work, and developing checks). Based on the nurses’ feedback and a literature • Interdisciplinary teams make wiser decisions review, the CUSP team developed a consensus because they have diverse and independent protocol, which stated that nurses instead of input. residents would perform all of the preps in the After the lecture, the participants were asked to colorectal surgery ORs, and CHG would be used answer 2 questions anonymously: for all patients, including those with ostomies. “Now we use CHG all the way up to the stoma • How will an SSI develop in the next patient? and use povidone-iodine on the stoma,” says Tra- • What can we do to prevent an SSI? cie Cometa, BSN, RN, a nurse clinician II who was The survey yielded 95 concerns. Reviewing on the CUSP team. those concerns, the team identified 6 interven- Cometa invited a representative from CareFu- tions to prevent SSIs (sidebar). sion, the vendor for ChloraPrep (2% CHG/70% isopropyl alcohol), to provide in-service educa- A surprising concern tion for all staff who worked in colorectal surgery. “The most surprising concern was that all There was concern that having the nurses patients were not getting the appropriate anti- perform the prep would slow down cases. The biotics,” says Dr Wick. “I think addressing the residents had performed the preps because they prophylactic antibiotic problem was one of the knew the specific area attending surgeons wanted key things we did.” prepped and could perform the prep before at- At Johns Hopkins, colorectal surgery patients tending surgeons arrived. who are allergic to penicillin receive clindamycin “We all agreed to try having the nurses apply a and gentamicin for surgical prophylaxis. CHG prep for 2 months,” says Dr Wick. “Because The team learned that anesthesiologists and we rapidly saw improvement in our surgical site surgeons had safety concerns about the large 5 infection rate after starting CUSP, that helped the mg/kg dose of gentamicin recommended by the surgeons get on board.” infection preventionists. Because of those con- “We are looking at spreading the practice to cerns, they were either holding the gentamicin the rest of general surgery,” adds Cometa. and just giving patients clindamycin or giving 2.5 mg/kg of gentamicin. Instituting CHG washcloths “We would have never known that if we In addition to standardizing the skin prep, the hadn’t tapped into the concerns of front-line pro- CUSP team introduced the use of washcloths im- viders,” says Dr Wick. pregnated with CHG. At the request of the CUSP team, practitio- “We used the CHG cloths because of the suc- ners from the epidemiology and infection control cess in other services with high infection rates,” service addressed the concerns and educated the notes Dr Wick. providers. As a new routine practice, all patients were That raised compliance with appropriate gen- given CHG washcloths and instructed to shower tamicin dosing from 33% to 92%. or bathe with them on the evening before surgery.

Patient Safety in the OR The OR Management Series 107 “I’m not sure they made a difference because most of the bacteria are from the colon, but they New national project aims helped to ensure the patients got a really good to lower SSIs bath the night before surgery,” she says. A national project has helped lower cen- Eliminating routine tral line-associated bloodstream infections The CUSP team decided to eliminate the rou- in the ICU by 40%. Could it do the same tine preoperative use of the mechanical bowel for surgical site infections (SSI)? prep after discussing literature that suggests the The new effort funded by the Agency for bowel prep may be associated with increased SSI Healthcare Research and Quality (AHRQ), rates. now signing up hospitals, enlists front-line One possible reason is that patients may be dehydrated from the bowel prep and require clinicians to uncover solutions for prevent- more fluids in the OR, which might put them at a ing SSIs in their own organizations. higher risk for infection, says Dr Wick. “Initially, we will focus on colorectal The mechanical bowel prep question is still surgery because that has a high compli- confusing, however, she says. After a year of cation rate,” says Sean Berenholtz, MD, omitting this practice, the CUSP team reintro- MHS, of the new Surgical Unit-based duced the mechanical bowel prep, this time with Safety Program (SUSP). oral antibiotics, based on new guidelines expected “What we hope to do in this project is to soon from the Infectious Diseases Society of give providers tools to better understand America, Society for Healthcare Epidemiology of where their defects are.” America, and the Surgical Infection Society. SUSP goes beyond process measures to Overcoming barriers track outcomes by partnering for data col- Partnering with a senior executive was a key lection with the American College of Sur- strategy in overcoming some tough barriers, notes geons National Surgical Quality Improve- Dr Wick. The executive’s role is to attend the ment Project (NSQIP) and the Centers for CUSP meetings, make resources available, and Disease Control and Prevention’s National assist with overcoming barriers. Healthcare Safety Network. There was also a problem getting anesthesia Participation in SUSP is free. But hospitals CUSP team members assigned to colorectal cases, need to commit resources, including execu- particularly CRNAs. tive partnership and time for a surgeon, an- With the senior executive, the CUSP leader- esthesia provider, and nurse to implement ship team met with the OR leadership, and slowly there was improvement in having CUSP team the interventions and monitor progress. members assigned to the ORs where colorectal SUSP is based at the Johns Hopkins surgery is performed. Now the initials CR (for Armstrong Institute for Patient Safety and colorectal) are put next to CUSP team members’ Quality. Learn more at www.hopkins- names so they can be assigned to the colorectal medicine.org/quality_safety_research_ ORs, notes Cometa. group/our_projects/action_II/SUSP/. SSI rates started improving once a team of providers aware of the problem was assigned to the colorectal patients. for surgical-site antisepsis. N Engl J Med. “Even before we had a lot of interventions 2010;362:18-26. Accompanying editorial, 75-77. implemented, we started to see an improvement DePalo V A, McNicoll L, Cornell M, et al. The in SSI rates,” says Dr Wick. “It was the teamwork Rhode Island ICU collaborative: A model for ❖ that really started making the difference.” reducing central line-associated bloodstream —Judith M. Mathias, MA, RN infection and ventilator-associated pneumonia statewide. Qual Saf Health Care. 2010;19:555-561. More on the Surgical Unit-Based Safety Program (SUSP) is at www.hopkinsmedicine.org/qual- Englesbe M J, Brooks L, Kubus J, et al. A statewide assessment of surgical site infection following ity_safety_research_group/our_projects/action_II/ colectomy: The role of oral antibiotics. Ann Surg. SUSP/ 2010;252:514-519. Guenaga K F, Matos D, Wille-Jorgensen P. Me- References chanical bowel preparation for elective colorectal surgery. Cochrane Database Syst Rev. Berenholtz S M, Pham J C, Thompson D A, et al. 2011;9:CD001544. Collaborative cohort study of an intervention to reduce ventilator-associated pneumonia in the Lee I, Agarwal R K, Lee B Y, et al. Systematic review intensive care unit. Infect Control Hosp Epide- and cost analysis comparing use of chlorhexidine miol. 2011;32:305-314. with use of iodine for preoperative skin antisepsis to prevent surgical site infection. Infect Control Darouiche R O, Wall M J, Itani K M F, et al. Hosp Epidemiol. 2010;31:1219-1229. Chlorhexidine-alcohol versus povidone-iodine

108 The OR Management Series Patient Safety in the OR Lipitz-Snyderman A, Steinwachs D, Needham D Sawyer M, Weeks K, Goeschel C A, et al. Using M, et al. Impact of a statewide intensive care evidence, rigorous measurement, and col- unit quality improvement initative on hospi- laboration to eliminate central catheter-asso- tal mortality and length of stay. Brit Med J. ciated bloodstream infections. Crit Care Med. 2011;342:d219. 2010;38[Suppl]:S292-S298. Noorani A, Rabey N, Walsh S R, et al. Systematic Waters H R, Korn R Jr, Colantuoni E, et al. The review and meta-analysis of preoperative an- business case for quality: Economic analysis of tisepsis with chlorhexidine versus povidone- the Michigan Keystone Patient Safety Program iodine in clean-contaminated surgery. Br J Surg. in ICUs. Am J Med Qual. 2011:26:333-339. 2010;97:1614-1620. Wick E C, Hobson D B, Bennett J L, et al. Implemen- Pronovost P, Needham D, Berenholtz S, et al. An tation of a surgical comprehensive unit-based intervention to decrease catheter-related bloodsafety program to reduce surgical site infections. stream infections in the ICU. N Engl J Med. J Am Coll Surg. 2012;215:193-200. 2006;355:2725-2732. Pronovost P J, Holzmueller C G, Sawyer M. A web- based tool for the comprehensive unit-based This article originally appeared in OR Manager, safety program (CUSP). Jt Comm J Qual Patient Saf. 2006;32:119-129. December 2012;28:1, 17-22.

Patient Safety in the OR The OR Management Series 109 Safer surgery: Six steps that aim for excellence in sterile processing

Fourth in a series on ten elements of safer surgery. tients, but if they don’t have the right equipment, they can’t do their jobs effectively. We never t’s axiomatic that sterile processing is criti- want to have something we’ve done to affect the cal to safe and effective surgical care. The patient.” Isterile processing department (SPD) is like an Sue Klacik, BS, CRCST, FCS, who manag- “engine room” for the OR, where the staff pro- es central sterile (CS) services at St Elizabeth duce the sterile instruments and other equipment Hospital, a 350-bed Level 1 trauma center in needed for surgical cases. Youngstown, Ohio, conveys the same message: An OR with a volume of 75 cases a day can re- “My staff know they are every bit as important as quire upwards of 50,000 individual instruments, the team in surgery.” many with complex and intricate parts. Any flaw She makes sure the staff are empowered. “If at in cleaning and reprocessing is a potential threat 2 am, they see something that doesn’t look right to patients. It’s a demanding job, and one that is for a case the next day, they contact surgery to see often unsung. if there’s a problem and discuss a way to resolve Surgical departments striving for safer care the issue.” include sterile processing as colleagues and allies. Valuing the staff carries through to compensa- OR Manager interviewed 4 SPD leaders about tion. These leaders make sure their staff’s pay is their efforts to build bridges with their surgical competitive with that of other area hospitals. colleagues, embrace continuous improvement, and focus on customer service. These are their Two: Stay in touch with the OR’s suggestions for achieving excellence in sterile needs processing. Visibility and customer service are leading strategies these leaders employ to make sure One: ‘Heart of patient care’ they’re meeting the OR’s needs. These SPD managers make sure their staffs know the essential role they play in patient care. Keep communication open Rudy Gonzales, MSN, RN, CNOR, CRCST, “I’ve learned over the years that if you don’t CHL, has led his department at the Louisiana want to hear from the OR, they will lose trust in State University Health Science Center in New you because you are not addressing the issues,” Orleans in recovering from the complete de- says Mark Duro, CRCST, FCS, manager of the struction of the SPD at the former Charity and Central Sterile Processing Department at New University Hospitals after Hurricane Katrina. England Baptist Hospital in Boston, a leading He’s participating in the building of a new re- orthopedic center performing 25 to 30 joint replacement University Medical Center to open placements a day. in 2015. When there is an issue in the OR, depend- Gonzales says he tells his staff: “The doctors ing on how serious it is, Duro goes directly to can cure disease, the nurses can care for the pa- the room. Less critical issues are reported on a communication sheet that records the date, time, personnel involved, the issue, suggestions Safer Surgery series for possible solutions, and a signature. Duro reviews the sheets once a week and addresses This series of articles covers Ten Elements the issues. for Safer Surgery developed by Advocate Health Care, a 10-hospital system in Participate in daily huddles the Chicago area. Every day at 1:30 pm, Klacik or a CS coordina- Previous articles in the series focused on: tor joins a huddle in the OR to review the next day’s schedule and determine needs. At 3 pm, she • OR governance: January 2013 huddles with the CS staff. • Safer surgical scheduling: February 2013 “We talk about what’s happening tomorrow,” • Presurgical assessment: March 2013. she says. “We discuss which trays to watch for. If loaner trays aren’t in, we start calling the vendor.”

110 The OR Management Series Patient Safety in the OR Ten components for safer surgery The components of Advocate Health Care’s Safer Surgery initiative: 1. Perioperative governing body 2. Single path for surgical scheduling 3. Preanesthesia testing (PAT) with standardized protocols/hospitalists 4. Document management system for scheduling and PAT 5. Excellence in sterile processing 6. Crew resource management 7. Implementation of a critical safeguards checklist 8. Daily huddle 9. Error reporting 10. Just culture Source: Advocate Health.

If necessary, she adjusts staffing to meet She also provides in-service education on all new the requirements of the next day’s surgical equipment, including the IFU. schedule. At St Elizabeth, certification of CS techs is a condition of employment. Klacik teaches the Round in the OR classes herself. The hospital purchases the books, Klacik and CS coordinators round in the sur- and education is conducted on work time. gery department throughout the day. “If surgery has a question or comment, they can stop and tell Four: Provide the right working us,” she says. “They know we are accessible, and conditions we can nip problems in the bud.” Klacik ensures the SPD staff have the proper equipment and work environment to do their Attend OR staff meetings jobs well. Duro attends OR staff meetings to share “At our work stations, we have the correct information. At one point, the OR was report- conditions—the right lighting, equipment like ing holes in sterilization wrappers. An OR magnifying glasses, quality monitors, and other staff member asked, “Why not use contain- tools,” she says. ers?” Duro had a chance to explain that many IFUs are available on PCs throughout the instrument sets have not been validated by the department, which provide access to onesourced- device manufacturer for the use of sterilization ocs.com, an online database of manufacturers’ containers. instructions. “We have to follow the manufacturer’s instruc- At New England Baptist, sterile processing is tions for use (IFU) for everything—not just the almost completely automated. In planning the equipment but also the packaging material,” he department, which opened 3 years ago, Duro and told them, noting that failure to follow the IFU his team scoured the US and Europe for the latest can incur liability. in technology. Three: Educate, educate Five: Support the staff and hold them Education of CS techs is the backbone of a accountable safe, efficient sterile processing program, Klacik Accountability goes hand in hand with education. emphasizes. “If someone has made an error, we bring it to “I can’t stress how important education is in their attention so the error doesn’t occur again,” this job,” she says. With today’s demands, “techs Klacik says. “They know what they do affects need to be technically trained and to have critical- patient care, and they are meticulous.” thinking skills.” Gonzales, who now has a master’s, relies on Klacik, an approved CRCST instructor, also the bedrock values he learned in the Army: “Make serves as the educator for the department. “We sure your staff have what they need to do the job, teach the standards and recommended practices, make sure they’re trained, and make sure their pay along with the rationale behind them,” she says. is correct. Then most things will work out.”

Patient Safety in the OR The OR Management Series 111 Six: Foster continuous improvement Encouraged by a Japanese sensei, the depart- At Virginia Mason Medical Center in Se- ment recently began working on a process to create just-in-time instrument sets built to order attle, which has pioneered Lean management ❖ in health care, the director of sterile process- for surgeons performing the next day’s cases. ing, Sam Luker, MBA, CRCST, and his team —Pat Patterson have a constant focus on eliminating waste and mistake-proofing sterile processing. Every day begins with a daily “newspaper” reporting on This article originally appeared in OR Manager, defects that reached the OR the previous day. April 2013;29:1, 6-7.

112 The OR Management Series Patient Safety in the OR Scope storage: Don’t get hung up on a number

ow long can a flexible endoscope be stored Society for Gastrointestinal Endoscopy and So- before it needs to be reprocessed for use in ciety for Healthcare Epidemiology of America Ha patient? Guidelines differ, raising ques- says the issue is unresolved and data is insuf- tions about the appropriate storage or “hang time.” ficient, adding that reuse within 10 to 14 days Evidence is limited. What’s the best course? of high-level disinfection appears safe. How do accreditation surveyors assess this? The Society of Gastroenterology Nurses and Though infections from GI endoscopes are Associates (SGNA) standards, revised in 2012, rare, estimated at about 1 in 1.8 million proce- refer to the Multisociety Guideline, saying the dures, contaminated scopes are linked to more issue “warrants further data and research.” health care-associated infection outbreaks than any other medical device, according to the Cen- ters for Disease Control and Prevention. Making an informed choice All of the published incidents of pathogen In considering hang time, managers need to re- transmission in GI endoscopy are linked to the view the evidence and make an informed decision failure to follow cleaning and sterilization/disin- appropriate to their organization, advises Cindy fection guidelines or defective equipment, notes Taylor, RN, BSN, MSA, RN, CGRN, nurse man- the 2011 Multisociety Guideline on Reprocessing ager of GI endoscopy/ bronchoscopy at Hunter Flexible GI Endoscopes. Holmes McGuire VA Medical Center, Richmond, Virginia. Improper cleaning and reprocessing “I don’t think there is a right or wrong answer, In discussing hang time, don’t miss the real as long as there is a rationale to back up the deci- reason infections are spread—improper scope cleaning and reprocessing. The most critical aspect of preventing trans- Training: The missing piece missions is to be sure the whole process is fol- in endoscope reprocessing lowed correctly, stresses Kathryn Snyder, BSN, MM, RN, CGRN, endoscopy/bronchoscopy/ Training is often the missing piece in en- motility manager at the University of Virginia doscope reprocessing, notes Kathryn Sny- (UVA), Charlottesville. der, BSN, MM, RN, CGRN. She offers a few reminders: At her institution, the University of Vir- • Is your staff up to date on the latest society ginia, Charlottesville, endoscopy techs are guidelines and manufacturers’ instructions for oriented for 6 weeks, not only on scope endoscopy equipment? reprocessing but also on assisting the care • Are all reprocessing steps followed all of the team before, during, and after the proce- time? dure. The techs are retrained annually and • Does the organization provide the resources to must demonstrate competency to an expert. ensure processes are performed correctly? Recently, endoscopy nurses also began • Do endoscopy technicians receive annual receiving annual training and compe- training and competency validation? tency validation on scope reprocessing • Is documentation complete and consistent for and handling. endoscope reprocessing throughout your or- “We found nurses weren’t accustomed ganization? to trouble shooting scopes and assisting the MDs if the scope got clogged and so Guidelines on hang time forth,” she says. “It was an eye opener for Two major guidelines differ in their recom- some of our newer nurses who had never mendations on storage for flexible scopes based reprocessed a scope before.” on the same 3 studies (sidebar): Nurses also are better able to respond to • AORN advises reprocessing scopes before use patients’ questions about reprocessing that if unused for more than 5 days. they may have read about on the internet. • The Multisociety Guideline from the American

Patient Safety in the OR The OR Management Series 113 Studies: Endoscope storage Contamination after storage An Australian study that sampled 200 endoscopes before the first case of the day found the overall contamination rate was 15.5%, with a pathogenic contamination rate of 0.5%. The mean time between the last case on one day and reprocessing before the first case on the next day was 37.6 hours (median 18.8 hours). The most frequently identified organism was coagulase-negative Staphylococcus, an environmental nonpathogenic organism. —Osborne S, Reynolds S, George N, et al. Endoscopy. 2007;39:825-830.

Testing reprocessed scopes A study tested 3 types of GI scopes (upper endoscopes, duodenoscopes, and colonoscopes) that had been reprocessed and stored in dust-proof cabinets. Samples were obtained daily for 5 days from the scopes’ surfaces, piston valve openings, and accessory channels. They then were brushed and flushed after 5 days. All scopes were bacteria free immediately after high level disinfection. In all, 4 of the 135 daily assays were positive, all for skin bacteria cultured from the endoscope surface. All flush-through samples were sterile. —Rejchrt S, Cermak P, Pavlatova L, et al. Gastrointest Endosc. 2004;60:76-78.

Three-phase study A 3-phase study evaluated 4 endoscopic retrograde cholangiopancreatography (ERCP) scopes and 3 colonoscopes. • Phase 1: Scopes were assayed after high-level disinfection and daily for 2 weeks. • Phase 2: This procedure was repeated to confirm the results. • Phase 3: Endoscopes were assayed after high-level disinfection and again after 7-day storage. In phase 1, 6 of 70 assays were positive, all in the first 5 days. No cultures were positive in phase 2. In phase 3, 1 scope had a positive culture but only for Staphylococcus epidermidis, a low-virulence skin organism. The authors conclude that reprocessing is unnecessary after at least 7 days of disuse and possibly up to 2 weeks. —Vergis A S, Thomson D, Pieroni P, et al. Endoscopy. 2007;39:737-739.

sion that is supported by the literature, the stan- after 12 days of hang time, Taylor notes. dard of care, and society guidelines,” she says. The hang time is documented: “Be sure your policy is attainable,” she adds. • using a printout from the reprocessing ma- “Better to not have a policy than to have one and chine not follow it.” • keeping the printout in a plastic sleeve at- Some issues to keep in mind: tached to the scope by a beaded chain • GI endoscopes must be properly cleaned and • scanning reprocessing information into each at a minimum subjected to high-level disinfec- patient’s medical record, including the HLD tion (HLD). parameters, date reprocessed, person who re- • Consult with your physicians and infection processed the scope, and the reprocessing prevention experts on the proper process for machine number. endoscopes used in immunosuppressed pa- Immediately prior to the scope’s use, the plas- tients or in sterile regions such as the biliary tic sleeve is removed, and the reprocessing infor- tree, pancreas, or peritoneal space. mation is verified by a nurse or technician. • If endoscopes are turned over frequently, stor- “This has become part of our time-out before age time may not be an issue. the procedure,” says Taylor. • Keep in mind that in the studies of storage time, Practice at UVA the types of organisms cultured from endoscopes after storage were primarily nonpatho- UVA is considering adopting a 2-week storage genic skin bacteria. time for flexible scopes, says Snyder. Storage time will be tracked by: The VA’s policy • using a standardized form to document the The Veterans Health Administration currently data and time endoscopes were reprocessed follows a directive to reprocess unused scopes and kept on file for 3 years

114 The OR Management Series Patient Safety in the OR • tagging each scope with the date and time it References was reprocessed AORN. Recommended practices for cleaning and processing flexible endoscopes and endoscope • removing the tag just prior to the scope’s inser- accessories. Perioperative Standards and Recom- tion in the next patient. mended Practices. Denver CO: AORN, 2012. “The idea is that you never use a scope without Petersen B T, Chennat J, Cohen J, et al. Multiso- taking the tag off,” she says. “And you take the ciety Guideline on Reprocessing Flexible GI tag off immediately before insertion, not when Endoscopes: 2011. Infect Cont Hosp Epidemiol. you are setting up the scope.” That is in case a 2011;32:527-537. www.asge.org/uploadedFiles/ physician decides to use a different scope at the Publications_and_Products/Practice_Guide- last minute. lines/Multisociety%20guideline%20on%20repro- cessing%20flexible%20gastrointestinal.pdf When surveyors visit Rutala W A, Weber D J. Guideline for Disinfection A surgeon surveyor from the Joint Commis- and Sterilization in Healthcare Facilities. Atlanta sion asked about hang time in a 2010 visit to Tay- GA: CDC, 2008. lor’s facility. “He just wanted to know if we had a policy,” she says. Schembre D B. Infectious complications associated with gastrointestinal endoscopy. Gastrointest At UVA, surveyors did not ask about hang Endosc Clin N Am. 2000;10:215-232. time during recent inspections by the Joint Com- mission and Centers for Medicare and Medicaid Society of Gastroenterology Nurses and Associates. Services (CMS). But that experience doesn’t nec- Standards of Infection Control in Reprocessing essarily apply to others, Snyder cautions. Surveys of Flexible Gastrointestinal Endoscopes. Chicago vary by state and surveyor. ❖ IL: SGNA, 2012. www.sgna.org —Pat Patterson This article originally appeared in OR Manager, January 2013;29:19-20, 23.

Patient Safety in the OR The OR Management Series 115 Spore test for liquid chemical sterilant processing system

spore test strip is now available for the should not be your first choice for items that come Steris System 1E Liquid Chemical Sterilant in contact with compromised tissue. AProcessing System. The Steris Verify Spore Test Strip for S40 was cleared by the Food and Monitoring liquid chemical sterilization Drug Administration (FDA) in June 2012. It’s important to know that the Verify Spore What is the role of this new spore test strip? Test Strip for liquid chemical sterilization is not How is this test method different from using the same as a BI used for steam sterilization. biological indicators (BIs) and chemical indicators In its regulatory documents for the spore test (CIs)? strip, the FDA notes that BIs are not appropriate The FDA, the Association for the Advancement for monitoring liquid chemical sterilization. The of Medical Instrumentation (AAMI), and the Steris FDA has not cleared any BIs for that purpose Corporation provide information that can help in because, the agency notes, the literature suggests using these test methods appropriately. that “sterilization with a liquid chemical sterilant may not convey the same sterility assurance as The role of liquid chemical sterilization other sterilization methods.” Liquid chemical sterilization differs from other The standard for a terminal sterilization pro- common sterilization methods that use heat or cess is an SAL of 10-6, which means there is less gas/vapor/plasma, the FDA notes on its website. than or equal to a 1 in 1 million chance that a sin- The FDA recommends that use of liquid chemical gle viable microorganism is present on a sterilized sterilants be limited to reprocessing only critical item. That is what a BI is intended to measure. devices that are heat sensitive and incompatible An SAL of 10-6 is appropriate for items in- with other sterilization methods. tended to come in contact with compromised Though the survival kinetics for microorgan- tissue (that is, tissue that has lost the integrity of isms for thermal sterilization methods, such as the natural body barriers), according to the AAMI steam and dry heat, have been extensively studied steam sterilization guideline (ANSI/AAMI ST79). and characterized, the FDA says the kinetics of The Verify Spore Test Strip contains a known sterilization using liquid chemical sterilants are number of bacterial spores (at least 5 log10 or 105 less well understood. per strip) of known resistance (Geobacillus stearo- The FDA’s guidance on liquid chemical steril- thermophilus) to a liquid chemical sterilant used ants/high-level disinfectants refers to literature in a defined processing system. The Verify Spore suggesting that sterilization processes based on liq- Test Strip does not demonstrate that conditions uid chemical sterilants “in general may not convey were adequate to achieve an SAL of 10-6, but it the same sterility assurance level (SAL) as steriliza- does tell the user that the sporicidal activity of tion achieved using thermal or physical methods.” the S40 sterilant dilution was able to kill at least 5 Other points by the FDA about sterilization log10 or 105 spores. with liquid chemical sterilants: Using spore test strips • Liquids cannot adequately penetrate barriers such as biofilms, tissue, and blood to attain organism Use of the Verify Spore Test Strip is optional as kill as thermal sterilization processes can. a means to test the sporicidal activity of the sterilant used in the System 1E, as noted in the Steris • The viscosity of some liquid chemical sterilants instructions for use (IFU). “impedes access to narrow lumens and matted If the spore test strip was needed for monitor- surfaces of devices.” ing the System 1E, it would have to have been • Devices cannot be wrapped or adequately con- cleared by the FDA at the same time as the System tained during processing “to maintain sterility 1E processor and chemical indicator (CI) were following processing and during storage.” cleared. This is a requirement for steam and low • Devices require rinsing “with water that typi- temperature sterilization processes new to the cally is not sterile.” market. These are reasons why the FDA cleared the In an e-mail communication, Steris stated, System IE as a processor and not as a sterilizer. “Steris recommends that the Verify Spore Test This means a liquid chemical sterilant process Strip be used daily in the first processing cycle of

116 The OR Management Series Patient Safety in the OR the day.” This means the strip is placed into the For facilities that wanted a spore test when the processor along with the items to be processed. System 1E entered the market, your wish has come The Steris IFU state to incubate the spore test true. But remember to run a CI in each load and strip at “55-60ºC (131-140ºF) for at least 24 hours.” document the results according to the recommen- If the spore test strip shows growth, the IFU say to dations in ANSI/AAMI ST58. ❖ “follow department procedures for liquid chemical —Martha Young, MS, CSPDT sterilant process failures.” President, Martha L. Young, LLC, providing Using chemical indicators SAVVY Sterilization The purpose of the CI is to measure the level of Solutions for Healthcare active ingredient in the liquid chemical sterilant. Woodbury, Minnesota A CI must be available for a liquid chemical steril- Martha Young is an independent consultant with ant to be cleared for market. long experience in medical device sterilization and Several CIs from different manufacturers are available to monitor the System 1E. disinfection. The Steris IFU for the Verify CI recommend use of the CI “during each processing cycle to detect the References presence of the active ingredient, peracetic acid, in Association for the Advancement of Medical the use dilution of S40 Sterilant Concentrate.” A note Instrumentation. Chemical sterilization and states that the Verify CI for the System 1E should be high-level disinfection in health care facilities. used in each load tested with a spore test strip. ANSI/AAMI ST58(R):2005. This document is The IFU describe what the CI’s “pass” level undergoing revision. means and how to tell if the processed items may be used or not. Association for the Advancement of Medical Instru- mentation. Comprehensive guide to steam steril- Physical monitors and documentation ization and sterility assurance in health care facilities. ANSI/AAMI ST79:2010 & A1:2010 & A2:2011. The computer-controlled System IE, according to the company’s information, “continually moni- Evaluation of Automatic Class III Designation (De- tors the cycle, including the full time, exposure Novo) for Steris Verify Spore Test Strip for S40. time, temperature range of the exposure time, and www.accessdata.fda.gov/cdrh_docs/reviews/ the conductivity of the use dilution.” K100049.pdf AAMI’s chemical sterilization and high-level Food and Drug Administration. Liquid chemical disinfection standard (ANSI/AAMI ST58) has disinfection. www.fda.gov/MedicalDevices/ recommendations for the documentation of ProductsandMedicalProcedures/GeneralHos- chemical sterilant cycles. In highlights: pitalDevicesandSupplies/ucm208018.htm • Printouts should be checked at the beginning Food and Drug Administration. Guidance Document: of the cycle to verify that the cycle identifica- Guidance for Industry and FDA Reviewers: Con- tion number has been recorded and that the tent and Format of Premarket Notification [510(k)] printer is functioning properly. Submissions for Liquid Chemical Sterilants/High Level Disinfectants. January 3, 2000. www.fda. • At the end of the cycle before items are re- gov/MedicalDevices/DeviceRegulationandGuid- moved from the processing equipment, the ance/GuidanceDocuments/ucm073773.htm operator should examine and interpret the printout to verify that cycle parameters were Steris. Personal communications by email with met and should initial the printout. Rosemary Niewolak, director, low temperature sterilization, Steris Corporation. August 16, 2012. • Printouts should be maintained, as should a record of repairs and preventive maintenance. Steris. Verify Spore Test Strip for S40 Instructions, Cycle documentation should include: identifica- 10005723 Rev B. Received by email from sales representative. August 14, 2012. tion of the processing unit, specific contents of the load, patient name, procedure, physician, exposure Steris. Verify Chemical Indicator for SYSTEM 1E Pro- time, temperature, date and time of cycle, chemical cessor, LCC016-20r03. Received by mail from sales concentration at exposure phase, name or initials representative. August 14, 2012. of operator, results of CI or spore strip testing, and reports of inconclusive or nonresponsive CIs. ANSI/AAMI ST58 recommends maintaining full traceability to the patient. This includes recording the load identifier on the patient chart or This article originally appeared in OR Manager, recording the patient name or other identifier on November 2012;28:24-25. the load record.

Patient Safety in the OR The OR Management Series 117 Taking control of implant processing practices

re you following recommended practices External chemical indicator (CI) when processing implants? Both the As- A Class 1 CI should be used on the outside Asociation for the Advancement of Medical of each package, unless the internal chemi- Instrumentation (AAMI) and the Association of cal indicator is visible, to distinguish between Perioperative Nurses (AORN) state that a load processed and unprocessed items. The indica- containing an implant should be quarantined tor should be examined at the end of the cycle, until the results of the biological indicator (BI) before it is dispensed, and before it is used in testing are available. The rationale is to reduce the the operating room. risk of surgical site infection (SSI). The Joint Commission’s National Patient Internal CIs Safety Goal NPSG.07.05.01 states that hospitals A Class 3, 4, 5, or 6 CI (use only in the specific should “implement evidence-based practices for cycles for which they are labeled) should be used preventing surgical site infections.” The goal‘s as an internal chemical indicator inside each pack- EP 3 says: age, tray, or containment device (reusable rigid Implement policies and practices aimed at sterilization container system, instrument case, reducing the risk of surgical site infections. These cassette, or organizing tray) to determine that the policies and practices meet regulatory require- sterilant penetrated the packaging and contacted ments and are aligned with evidence-based the implant being processed. guidelines (for example, the Centers for Disease Place the CIs in the areas least accessible to the Control and Prevention and/or professional or- sterilant. The CI should be retrieved and read in ganization guidelines). the OR before the item is placed in the sterile field. Thus, if you are releasing implants before BI If the CI response indicates an ineffective steril- results are available, you are not adhering to ization process, the package in question should guidelines and thus not implementing an evi- be sent back to the sterile processing department dence-based practice that prevents SSIs. (SPD) for reprocessing. How should I monitor implant loads? Biological indicator Routine release of implant loads should be A BI process challenge pack (BI PCD) contain- an active decision based on the evaluation of all ing a Class 5 integrating CI should be used in each available data. AAMI recommends in its ST79 load that contains an implant. The implant should steam sterilization standard that an experienced be quarantined until the BI testing is available. and knowledgeable person should make that AAMI states: “Releasing implants before the BI decision at the end of the steam sterilization results are known is unacceptable and should be cycle after evaluating the results of each moni- the exception, not the rule.” toring tool. AAMI recommends using these In documented medical exceptions, the im- monitoring tools: plant could be released based on the results of a Physical monitors Class 5 CI (not a Class 6 CI). These are the recorders, displays, digital print- Documenting exceptions outs, and gauges on steam sterilizers that read the AAMI provides an example of an implant log time, temperature, and pressure of the cycle. and an exception form to use for documenta- If the sterilizer has a recording chart, it should tion in Annex L of the ST79 standard. The form be checked each morning to ensure chart paper is includes the patient’s name, surgeon’s name, inserted and the pen is functioning. The date and time of procedure, reason for premature release sterilizer number should be marked on the chart of implant, and what could have prevented this before each cycle is started. premature release. For printouts, verify that the cycle identifica- The Joint Commission uses the AAMI ST79 tion number has been recorded and that the paper standard during surveys and expects to see that is functioning. At the end of the cycle, verify by ST79 Section 10.6.3 and Annex L are being used. reading and recording your initials that the cycle It is important to have a surgeon authorize parameters are correct for the load contents. the early release of implants before the BI re-

118 The OR Management Series Patient Safety in the OR New guidance on loaner sets As a help for managing loaner sets, the International Association of Healthcare Central Service Materiel Management (IAHCSMM) has a new Position Paper on the Management of Loaner Instrumentation. The paper recommends that loaner instrumentation be received in the facility’s decontamination area at least: • 2 working days (48 hours) before a scheduled case for existing sets • 3 working days (74 hours) for new sets. If loaner sets aren’t received in time, the OR may end up using immediate-use steam sterilization (IUSS) (previously called flash sterilization)−a practice strongly discouraged for implants. IUSS should not be performed on implants, except in a documented emergency when no other option is available, according to the recent multi-society position paper on IUSS from AAMI, AORN, and other organizations. AORN states in its recommended practices for sterilization that, in an emergency, when flash sterilization of an implant is unavoidable, a rapid-action BI with a Class 5 chemical integrating indicator should be run with the load. The implant should be quarantined on the back table and not released until the rapid-action BI provides a negative result. This statement is intended to discourage use of IUSS. If IUSS is used, the manufacturer’s written IFUs for cleaning, packaging, loading, and sterilization parameters should be followed. sults are available. This documentation should Removal of the implant (ie, joint, vascular be used to determine patterns of events that graft, or intraocular lens) may be necessary to cause an emergency release of implants so that stop the infection, and this could cripple or kill the situation can be corrected. patient. That’s why it’s critical to take every step OR personnel have told me that if the liability possible to ensure implants are properly sterilized is shifted to the surgeon, the practice of releasing and BI results are negative before the implant is implants early or using immediate-use steam ster- used on a patient. ilization is dramatically reduced. Why aren’t implants quarantined? If the BI is positive There are many reasons why implants may be If the BI is positive or the Class 5 CI indicates released prematurely. These are a few: an ineffective sterilization process, the implant • Loaner instruments may not arrive in suffi- should not be used. cient time to process the devices properly and If the cycle parameters, the external or internal quarantine implants. That can be the result of chemical indicator results are not correct, or the a loaner policy that is not successful at meeting BI is positive, do not use the load. Inform the the AAMI standard and the facility’s needs. appropriate supervisor so appropriate follow-up • Poor scheduling by the hospital or vendor, measures can be initiated. insufficient vendor inventory, or emergen- Appropriate follow-up measures for monitor- cies are other reasons. Possibly, the manu- ing products that indicate a sterilization process facturer’s written instructions (IFU) did not failure are described in the AAMI steam steriliza- arrive with the sets, and obtaining those tion standard under Section 10.7.5 (Actions to take delayed the processing. when biological indicators, chemical indicators, or physical monitors indicate a failure). All monitoring • Lack of inventory, whether loaner, consign- information should be fully traceable to the patient. ment, or owned implants/instruments, may not be sufficient to meet the surgery schedule. Why are improperly processed Instruments that arrive broken or dirty can implants a risk? also delay processing. Implants released before the BI result is known • OR block schedules may require use of one- may have microorganisms on them that could of-a-kind instruments in specialty trays or cause an SSI, which may not be evident for up to loaner/consignment trays for back-to-back a year after surgery. cases. During implant surgery, removal and manipu- • Resources may be lacking, such as personnel, lation of the tissue immediately adjacent to the appropriate equipment, cleaning agents, tools implant create an area where microorganisms recommended in the IFUs, and space in SPD. could multiply. In addition, surgery interrupts A new position paper on loaner sets can help the blood supply, which prevents antibiotics from in developing your own policy (sidebar). contacting the microorganisms.

Patient Safety in the OR The OR Management Series 119 How do I change practice? References How can you stop the practice of releas- AORN. Recommended practices for maintaining a ing implants for use before the BI results are sterile field. Perioperative Standards and Recom- known or using immediate-use steam steril- mended Practices. Denver, CO: AORN, 2011. ization? Be sure you and your superiors are www.aorn.org aware of the Joint Commission NPSG.07.05.01, AORN. Recommended practices for sterilization in in particular, EP 4, which states: “As part of the perioperative practice setting. Perioperative the effort to reduce surgical site infections, Standards and Recommended Practices. Denver, conduct periodic risk assessments for surgical CO: AORN, 2011. www.aorn.org site infections in a time frame determined by Association for the Advancement of Medical In- the hospital.” strumentation. Comprehensive guide to steam This could be interpreted to apply to the release sterilization and sterility assurance in health of implants. If you continue to release implants care facilities. ANSI/AAMI ST79:2010 and before the BI results are known or process implants A1:2010 (Consolidated Text). Arlington, VA: by immediate-use steam sterilization, you need to AAMI, 2010. www.aami.org do a risk assessment to determine how to eliminate Immediate-Use Steam Sterilization. Multi-society these practices. statement. www.aami.org/publications/stan- Management teams from the operating dards/ST79_Immediate_Use_Statement.pdf room, SPD, infection prevention, and risk International Association of Healthcare Central Ser- management departments need to work to- vice and Materials Management (IAHCSMM). gether to develop policies and procedures Position Paper on the Management of Loaner to ensure all implants are not released until Instrumentation and Sample Policy & Procedure the BI results are available, and implants for Loaner Instrumentation. http://iahcsmm. are never processed by immediate-use steam org/CurrentIssues/Loaner_Instrumentation_Po- sterilization. sition_Paper_Sample_Policy.html Meeting the AAMI and AORN recommenda- Joint Commission. Hospital Accreditation Standards. tions is a step closer to eliminating SSIs and im- Oakbrook Terrace, IL: Joint Commission, 2011. proving patient outcomes. ❖ —Martha Young, MS, CSPDT Klacik S. Worth the risk: Performing a risk assessment in Central Sterile Service Department. President, Martha L. Young, LLC, providing healthVIE.com. May 2011. SAVVY Sterilization Solutions for Healthcare, Seavey R. Getting a handle on loaner instrumenta- Woodbury, Minnesota tion. healthVIE.com. March 2011.

Martha Young is an independent consultant with This article originally appeared in OR Manager, long experience in medical device sterilization and January 2012;28:21-23. disinfection.

120 The OR Management Series Patient Safety in the OR Unprocessed tray incident prompts investigation, leads to process improvements

he circulating nurse was cleaning up after diately adjacent to the sterile storage area. The surgery in an ambulatory surgery center unsterilized instrument tray was inadvertently T(ASC) when she noticed the internal chemi- placed in the sterile storage area. cal indicator (a Class 5 integrating indicator) had not reached its appropriate endpoint response, First event which is a pass. That meant an unprocessed in- The first event that led to use of the unprocessed strument tray had been used on the patient. Her instrument tray was that the tray was placed in the discovery set off an investigation to determine sterile storage area and released for use. Personnel why this occurred. did not read the external chemical indicator on the Could this happen in your facility? This ar- tray before it was released. Though a barcode scan- ticle discusses the events that led to the use of ning system was used in the department, the sys- the unprocessed tray and describes the process tem did not have the capability to identify whether improvements implemented to reduce the chance a package had not been processed. for such an event in the future. Process improvements to consider Patient notification • Update or write a policy and procedures that After the unprocessed tray was discovered, the state actions to take when a sterilizer is removed surgeon promptly informed the patient in a man- from service so all personnel know where to ner that conveyed full disclosure, compassion, place trays/packages to be sterilized once the and accountability. The surgeon also prescribed sterilizer is placed back into use. antibiotics to decrease the risk of postoperative • Review the storage areas in the sterile process- infection and closely monitored the patient for ing area to determine if more space can be signs and symptoms of infection. created for storage of unsterile items. A human Although the risk of transmission of blood- factors approach would be to avoid having the borne pathogens was assessed as low, the facility sterile and unsterile storage areas next to each followed its procedure for management of patient other to prevent medical devices from being exposure to blood and body fluids. The patient stored in the wrong area. underwent postexposure testing for bloodborne • Upgrade the instrument-tracking system or pur- pathogens for 6 months after the surgical proce- chase a new workflow management information dure, as recommended by the Centers for Disease system with the capability of scanning packages Control and Prevention. before and after the sterilization process, includ- Root cause analysis ing when they are released for use, to determine A team of the ASC’s stakeholders was called if they were processed. The results of the physi- together to determine how an unprocessed in- cal monitors and chemical and biological indica- strument tray was used for a procedure and tors could also be accessed at this time. Such a how to prevent this from happening again. The system could alert you if the wrong sterilization team consisted of the surgeon, OR staff who cycle was used, if the physical monitoring results were in the room during the case, and nursing were not correct, or if a biological indicator was and physician leaders from the departments of not run with an implant. This is just a short list of surgery, sterile processing, infection prevention, features of newer information systems. and patient safety. • Train OR/sterile processing personnel to read By the time the team met, ASC staff and and identify the acceptable endpoint results of the leaders had conducted a preliminary investiga- external chemical indicator to ensure the packages tion and made some discoveries about why the have been through the process before they are re- instrument tray was not processed. A few days leased for use. Verify and document competency. prior to the incident, a sterilizer needing repair • Ensure that an experienced, knowledgeable had been taken out of service, creating a backup person makes decisions about load release of trays to be loaded into the remaining steril- based on the evaluation of all available data izer, which was operating correctly. The physical (physical monitors, chemical and biological space in the sterilizing area was small and imme- indicators) for particular loads.

Patient Safety in the OR The OR Management Series 121 Second event • Minimize interruptions during the room setup, The second event that led to the use of the and establish a feasible time frame for turnover unprocessed tray was failure of the OR staff to to reduce the chance for mistakes that could af- read external and internal chemical indicators. fect patient safety. Contributing factors to this event included: Risk assessment • A new employee with previous OR experience Doing a root cause analysis after an event was setting up the case. The handoff process for helps to identify possible sources for the event nurse preceptors did not provide clear commu- and action plans to prevent future occurrences. nication about specific skills for which the new Facilities should also perform a proactive risk employee was expected to demonstrate compe- assessment. This process includes identifying the tence, including chemical indicator reading. likelihood that such an event could occur, the • The day the chemical indicator was not read consequences if an event does occur, assessment was a heavy case-load day, and there was pres- of how to prepare the facility to manage the event, sure to turn over rooms as quickly as possible. implementation of actions to take to ensure an • During setup of the case, nurses reported fre- event does not occur, and communication of the quent interruptions by anesthesia providers changes being implemented to prevent an event. and other staff. Consider performing a risk assessment of the sterilization process (eg, decontamination, prepa- Process improvements to consider ration and packaging, sterilization, quality con- • Use the AORN Comprehensive Surgical Check- trol, sterile storage, and product distribution) to list, which includes recommendations from the identify events that could lead to failure. Elimi- ❖ World Health Organization and the Joint Com- nating risk points helps improve patient safety. mission’s Universal Protocol and National Patient —Martha Young, MS, CSPDT Safety Goals. This is a single, comprehensive, multidisciplinary checklist to use for preproce- President, Martha L. Young, LLC, providing dure check-in, sign-in, time-out, and sign-out for SAVVY Sterilization Solutions for Healthcare every surgery to reduce surgical complications Woodbury, Minnesota and mortality. During the time-out, the scrub person and circulating nurse should check the box, “Sterilization indicators have been confirmed.” Martha Young is an independent consultant with long experience in medical device steriliza- • Train OR personnel to read and identify the acceptable endpoint results of the external tion and disinfection. chemical indicator and internal chemical indicator to ensure the trays/packages have References been through the sterilization process, and the AORN. AORN Comprehensive Surgical Checklist. sterilant reached the inside of the tray/pack- www.aorn.org ages before they are introduced to a sterile AORN. Recommended Practices for Sterile Techniques. field. Verify and document competency. The Perioperative Standards and Recommended Prac- preceptor also needs to check the chemical tices, Denver, CO: AORN, 2013. www.aorn.org. indicator results before placing the set on a sterile field. A second check by another staff Association for the Advancement of Medical In- member would add another safety factor. strumentation. Comprehensive guide to steam sterilization and sterility assurance in health care • Follow the AORN recommended practice for facilities. ANSI/AAMI ST79:2010 & A1:2010 & sterile technique, which states, “Perioperative A2:2011 & A3:2012 (consolidated text), Arlington, team members should inspect the steriliza- VA: AAMI, 2012. tion chemical indicator in the sterile package Centers for Disease Control and Prevention. Updated to verify the appropriate color change for the US Public Health Service guidelines for the man- sterilization process selected.” This is done agement of occupational exposures to HBV, HCV, before the package is placed on the sterile field. and HIV and recommendations for postexposure • If your facility uses rigid sterilization container Prophylaxis. MMWR. 2001;50(RR11):1-42; www. systems, open the container on a separate clean, cdc.gov/mmwr/preview/mmwrhtml/rr5011a1. flat, and dry surface to inspect the integrity of htm#contentarea. the packaging (eg, security locks, latch filters, Centers for Disease Control and Prevention. Updated valves, and tamper-evident devices to ensure US Public Health Service guidelines for the manage- they are intact). Check the endpoint results of ment of occupational exposures to HIV and recom- the external indicator before opening the con- mendations for postexposure prophylaxis. MMWR. tainer and the internal indicator before placing 2009;54(RR-9); www.cdc.gov/mmwr/PDF/rr/ the tray on the sterile field. Place the tray on the rr5409.pdf. sterile field only if the integrity of the container This article originally appeared in OR Manager, is not compromised and the chemical indicators July 2013;29:16-17. have reached their acceptable endpoint.

122 The OR Management Series Patient Safety in the OR V. Preoperative Screening

Patient Safety in the OR The OR Management Series 123 Preoperative screening program reveals missed diagnoses and reduces mortality

ancelled surgical procedures at Carilion Preoperative screening lacking Roanoke Memorial Hospital (CRMH) in Because southwest Virginia has a relative CRoanoke, Virginia, are considered a suc- shortage of primary care physicians and because cess rather than a failure. primary care physicians in Virginia aren’t re- “That’s because we cancel procedures for imbursed for preoperative screening, it became cause,” says Sandy Fogel, MD, FACS. habit over the years for surgeons to do their own Before 2010, many patients at CRMH were screening, notes Dr Fogel. “As we discovered in having surgery with undiagnosed, untreated our chart reviews, many of the patients were not medical problems, and postoperative 30-day mor- adequately screened preoperatively,” he says. tality was too high. The NSQIP findings prompted Dr Fogel and After a preoperative screening clinic was set other surgeons to first seek help from the primary up, however, postoperative 30-day mortality was care physicians. But it would have been overly cut almost in half at CRMH, a 763-bed hospital burdensome and time-consuming to do complete with 31 ORs. preoperative screening of all surgical patients. These days, a patient who is found to have an The surgeons then considered other preopera- abnormal ECG during preoperative screening, tive screening models: for example, may need a stress test and an angio- • A preoperative screening service run by hired gram, so the surgery is cancelled. primary care physicians. This idea was rejected “That’s a potential cardiac complication or because the hospital wouldn’t be reimbursed death we have avoided,” says Dr Fogel, a general for the preoperative assessments and therefore surgeon and the American College of Surgeons didn’t want to pay additional salaries to physi- National Surgical Quality Improvement Program cians hired for that purpose. In addition, the (ACS-NSQIP) champion at CRMH. patients’ primary care physicians would be Quality report prompted change cut out of the loop with another primary care Implementation of the preoperative screen- physician taking care of their patients. ing clinic was spurred by CRMH’s first ACS- • All histories and physicals done by nurse prac- NSQIP report after becoming a member in titioners. This model was deemed too expen- 2007. sive, and the surgeons decided it would take “Our first report showed that surgical mortal- too long to find and hire the 10 or more nurse ity was significantly higher than expected and practitioners they needed. significantly higher than the national average,” • An anesthesiologist-run clinic. Anesthesiolo- says Dr Fogel. gists were also in demand for clinical duties He put together a working group to review and could not be spared. patient charts and find the cause of the high Finally, the surgeons decided on a preopera- mortality rate. This group consisted of both tive screening clinic run by RNs. physicians and nurses who reviewed charts To help them develop a screening tool, the sur- and brought their different perspectives to the geons asked primary care, internal medicine, cardi- project. ology, pulmonary, and infectious disease practitio- “The single finding that made us think we ners what specific questions they usually ask their were operating on patients with undiagnosed patients to pick up on a disease. diseases was that admitting nurses were report- The final list of questions was made into a ing that patients were short of breath at rest and computer-based checklist for the preoperative there were no diagnoses in the chart to explain screening nurses to use, and it was incorporated why,” he says. into the hospital’s electronic medical record. Looking further, the group found that 42% of hyperglycemic patients were not diagnosed as RNs screen all patients diabetic. They also found patients with angina The preoperative screening clinic was opened who had no diagnosis of coronary artery disease adjacent to the hospital in 2010. Every patient and hypertensive patients who had no diagnosis scheduled for surgery is required to undergo a and were not on any medications. preoperative assessment by a nurse.

124 The OR Management Series Patient Safety in the OR and statistically significant,” Agathoklis Konstantinidis, MD, told OR Manager. Dr Konstantinidis, a general surgery resident at CRMH, compiled the preoperative screening data for a presentation at the ACS-NSQIP Na- tional Conference in July. Between July 2007 and December 2009—before the Source: Carilion Roanoke Memorial Hospital. preoperative screening clinic was start- There are 15 nurses in the preoperative clinic ed—the odds ratios who work from 7 am to 8 pm in staggered shifts for 30-day mortality in all cases were 1.40, 1.43, to accommodate the patients’ schedules. They 1.58, and 1.56 in successive ACS NSQIP 6-month assess 100 surgical patients per day, including reporting periods (chart). endoscopy patients. Beginning with the first report after implemen- Spending approximately 1 hour with each pa- tation of the preoperative screening program in tient, the nurses discover an enormous number of 2010, there was a progressively decreasing odds undiagnosed problems, says Dr Fogel. ratio for 30-day mortality in successive reporting Some of the screening is done by telephone. periods: 1.26, 1.19, 1.14, and 0.86. In the last report For example, a 20-year-old man scheduled for in 2012, the odds ratio dropped to 0.84, says Dr an inguinal hernia repair would not have to be Konstantinidis. screened at the clinic unless the nurses found Of more than 20,000 patients who were problems during the telephone assessment. screened in 2012, 5,866 patients had some previ- If a problem is identified in the clinic, the ously unidentified risk factor: patient’s primary care physician is contacted. • 3,691 had undiagnosed obstructive sleep apnea Because the primary care physicians are now • 2,361 had an abnormal preoperative ECG seeing the patients for a particular problem such • 437 had undiagnosed diabetes as uncontrolled diabetes, an abnormal ECG, or • 192 had undiagnosed hypertension uncontrolled hypertension—not just for preoperative screening—their time is better spent, notes • 67 had undiagnosed shortness of breath Dr Fogel. Other risk factors also were found, and some pa- If the primary care physician prefers to have a tients had more than 1 undiagnosed problem. patient assessed by a specialist such as a cardiolo- In 2012, as a result of the screening, surgery gist, the preoperative screening nurses make all of for 218 patients was cancelled and 147 were re- the arrangements for the patient. ferred to cardiology specialists for further evalu- Dr Fogel notes that when they were setting up ation. In the past, operations were performed the clinic, they persuaded each specialty service to without knowledge of patients’ risk factors, Dr keep open slots each day for these urgent preop- Konstantinidis notes. erative visits. “We have been pretty successful in The last time Joint Commission surveyors vis- getting that accomplished,” he says. To help with ited the hospital, Dr Fogel says, they were shown this, patients now come to the clinic 1 to 2 weeks the results of the preoperative screening process, before surgery instead of 2 to 3 days ahead. “If and the Joint Commission asked CRMH to put it we pick up abnormalities, there is either time to on their website as a best practice. correct them or time to postpone their surgery,” “We are very proud of that,” he says. ❖ he says. —Judith M. Mathias, MA, RN Mortality cut almost in half “After implementation of the new preoperative screening clinic, overall 30-day surgical mortality This article originally appeared in OR Manager, decreased from 3.5% to 1.9%, which is clinically December 2013;29:12-13.

Patient Safety in the OR The OR Management Series 125 Safer surgery: The preoperative testing process

Ten elements of safer surgery. The third in a se- When scheduling, surgeons’ offices must fax a ries, this article focuses on presurgical evaluation. standard form with certain required information, such as the patient’s diagnosis, the procedure, aking sure patients have the appropri- and any comorbidities. (See February 2013 OR ate preoperative preparation, including Manager. The form is available in the OR Man- Mtesting, is necessary not only for pa- ager Toolbox at www.ormanager.com.) tients’ safe care but also for a smooth process on The registration department contacts the patient the day of surgery. to set up a phone screening or in-person appoint- Advocate Health Care, a Chicago area system, ment. The decision for phone screening or an has standardized preop testing requirements and appointment is primarily the surgeon’s choice. Pa- the patient history form for 9 of its hospitals to tients who are admitted and do not have a primary help streamline the process. The preadmission care physician on staff are assigned a hospitalist, testing (PAT) is one of 10 components of Advo- who will see them in PAT. cate’s Safer Surgery program (sidebar). PAT guidelines The project was led by David Young, MD, di- ALG prefers that surgeons and primary care rector of preanesthesia testing, and Cindy Mahal- physicians delegate preop testing and evalua- van Brenk, MS, RN, CNOR, executive service line tion to its PAT department. Many physicians do director for surgery at Advocate Lutheran General so because it streamlines their process and helps (ALG) Hospital in Park Ridge, Illinois. Dr Young is ensure that a case won’t be canceled because the also a consultant with Surgical Directions. patient wasn’t evaluated according to the appro- ALG performs about 12,000 procedures a priate guidelines. year in its main OR and 6,000 in its ambulatory “A primary care physician doesn’t want to lose surgery unit. surgeon referrals by not having patients properly In developing its preoperative program, ALG prepared for surgery,” Mahal-van Brenk notes. strived to achieve what Dr Young terms “the ideal PAT state”: Preop appointments • Patients are preregistered by phone within About 20% of ALG’s patients are seen in per- 24 hours of surgery scheduling. As soon as son before the day of surgery. The PAT unit is patients are preregistered, they are triaged for located on the first floor with valet parking avail- PAT. able, and testing is performed at that location. • Patient charts are completed 3 days prior to The PAT department has 2 sections. The surgery as a goal. preop evaluation unit where patients are seen • The patient history tool is standardized in the is staffed by experienced RNs and hospital- patient record. ists. Charts are assembled and preop phone calls are made in a separate office. The unit is • Lab and ECG testing is conducted on site in a staffed by 7 RNs. location convenient for patients. • Testing is determined according to standard- Meeting the 3-day goal ized guidelines based on the patient’s condi- Meeting the goal of having patients’ charts tion and complexity of surgery. prepared 3 days ahead of surgery requires coor- • Guidelines are established for lab and ECG dination. Documents are managed electronically results that will be considered abnormal. using fax-filing software to avoid having to man- Here’s a look at each step in the process. age paper forms. “When a patient’s information comes in, it Registration and triage goes into the patient’s chart—an electronic file As soon as the hospital receives a surgical folder—by day of the week they are having sur- scheduling request, the patient is preregistered by gery,” Mahal-van Brenk explains. phone, and the procedure is given an encounter Nurses review lab results and other informa- number, allowing the nurses to document in the tion as it comes in, referring to guidelines for record. abnormal test results.

126 The OR Management Series Patient Safety in the OR If a finding is abnormal, it is immediately sent The guidelines were developed by a team of to the primary care physician or to one of the hos- nurses and anesthesia providers who exam- pitalists as the first line of triage. ined current standards and best practices, If information is missing 3 days before surgery, Mahal-van Brenk says. nurses contact the office. Mahal-van Brenk in- Having a project manager is essential when structs them to communicate directly with the phy- conducting a project across multiple facilities, sician or the physician assistant rather than leave Dr Young stresses, adding that this role can’t be a phone message. Text messaging can be helpful. performed by a person who already has another clinical or management position. “Someone has to Daily huddle own the process who doesn’t also have a full-time Missing information is also addressed in the position in their own facility.” daily huddle held to review the next day’s cases. The huddle, attended by representatives from Communicating with MD offices anesthesia, nursing, PAT, and sterile processing, To make sure all of the physician offices were reviews the schedule, chart completeness, and familiar with Advocate’s preop guidelines and other preparations needed to make sure surgery the expectations, Mahal-van Brenk and Dr Young proceeds safely and smoothly. met with them directly. “If a chart is incomplete, we usually make a In the meetings, “We let them know what we call [to the surgeon] to say it can’t be the first were doing, why we were doing it, and explained case,” she notes. the hospitalist model. If an office has a pattern of incomplete charts, “The hospitalists help them postoperatively,” Mahal-van Brenk follows up herself, contacting she points out, “because they follow their patients the office and meeting with the staff if necessary. in the hospital, managing their diabetes, resuming She also takes time to meet with new office staff. blood pressure medication, and so forth.” ❖ “We meet one on one to get them on board —Pat Patterson and explain the process,” she says. “That builds relationships, and they have a resource to ask questions. That one-on-one time is key.” Previous articles in the series focused on OR governance (January 2013) and safer surgical sched- Achieving consensus uling (February 2013). Because the Advocate hospitals have worked together on multiple projects, a pro- This article originally appeared in OR Manager, cess was established for developing consensus March 2013;29:18-19. on preop testing and evaluation guidelines.

Patient Safety in the OR The OR Management Series 127 Why are there so many unneeded preop tests?

hat preoperative tests does your fa- had preop testing without an indication, com- cility require for a healthy 40-year- pared to 33% of patients under age 20. Wold having a knee arthroscopy? What Focusing on Texas, they discovered testing pat- about a healthy 82-year-old having an elective terns varied widely in the Medicare population. procedure? Do these patients need testing at all? “You would expect that 80-year-olds having A good deal of testing is performed without hernia repair in an elective setting would be simi- clinical indications, studies have found. lar no matter where they live,” she says. Yet chest Researchers at the University of Texas Medi- x-ray rates ranged from 10% in some locales to 90% cal Branch (UTMB), Galveston, are learning more in others. ECGs and other tests showed similar about what drives overuse. variations. In 2 reports in the past year, they documented “This suggests physician or facility practice pat- unnecessary testing in patients having elective terns and not patient characteristics are driving the hernia surgery and patients having noncardiac use of laboratory testing,” she says. surgery who had cardiac stress testing. They’re also finding wide geographic varia- Communication gaps? tions, similar to those seen for elective surgery. Dr Riall has observed that there’s often miscom- They’ve learned testing is more prevalent in areas munication about which tests are needed. In her or- with higher rates of malpractice suits. ganization, 80% of the tests are ordered by surgeons. The findings are leading to discussions about the “A lot of surgeons we talk to say, ‘We wouldn’t need for standardized national guidelines, Taylor order the tests, but the hospital or facility requires Riall, MD, PhD, associate professor in the Depart- it,’” she notes. “Or they say, ‘The anesthesiologist ment of Surgery at UTMB, told OR Manager. She will cancel the case if we don’t order them.’ Then also holds the John Sealy Distinguished Chair in the anesthesiologists will say, ‘We don’t require Clinical Research. these tests, but the surgeons order them.’ “Many are ordered by residents. They do it Studies document overtesting because they’re afraid the case will be canceled if In the study of elective hernia repair, 64% of they don’t,” she says. 47,000 ambulatory surgery patients had preop The researchers plan to survey surgeons in laboratory testing. More than half of those with Texas about tests they are required to perform. no documented comorbidities had testing. Yet Though many hospitals and health systems test results didn’t make a difference in whether have developed their own consensus guidelines on surgery went forward. In a subgroup tested on testing, Dr Riall believes a national effort is needed. the day of surgery, 62% had at least one abnormal “I think we have to develop clear and consis- result, but hernia repair was performed anyway. tent guidelines that all of the groups would agree Nor did the abnormal results predict postop com- on,” she says. That might also help to alleviate plications these patients would develop. worries about malpractice suits. ❖ In the second study of 75,000 Medicare patients —Pat Patterson having noncardiac surgery, 4% had a cardiac stress test though they had no indications for that test. Un- References necessary testing rates varied geographically from Benarroch-Gampel J, Sheffield K M, Duncan C B, et al. 2.7% in the Pacific West to 4.7% in the Midwest. Preoperative laboratory testing in patients under- This unneeded testing could be a significant going elective, low-risk ambulatory surgery. Ann Surg. 2012;256:518-528. cost to Medicare, which reimburses from $92 to $341 for a stress test, depending on the type, the Sheffield K M, McAdams P S, Benarroch-Gampel authors commented. J, et al. Overuse of preoperative cardiac stress testing in Medicare patients undergoing elective Overtesting in the elderly noncardiac surgery. Ann Surg. 2013;257:73-80. Overuse of testing is even more prevalent in healthy older patients, Dr Riall’s group has This article originally appeared in OR Manager, learned. An analysis of Medicare data showed March 2013;29:20. 75% of those aged 81 to 90 having elective surgery

128 The OR Management Series Patient Safety in the OR VI. Retained Surgical Items

Patient Safety in the OR The OR Management Series 129 Focus shifts to device fragments, small miscellaneous items in RSIs

hough retained surgical items (RSIs) cases Dr Gibbs has termed these items “surgical are rare, they do happen, and they take a junk.” Theavy toll throughout the system in terms Orthopedic surgery cases account for the larg- of steep fines, malpractice claims, and compro- est number of these small miscellaneous items and mised patient safety. Estimates of RSIs range UDFs, which often are the result of breakage of tools from 1 in 1,000 to 1 in 7,000 procedures. And a when used against bone. New to the scene are items 2003 study by the Agency for Healthcare Research such as guide wires, catheters, stents, and sheaths, and Quality found that patients with RSIs had a which are left in patients whose procedures are mortality rate 2.14% higher than controls, excess performed in cardiac catheterization labs, interven- hospital stays of 2.08 days, and excess costs of tional radiology labs, and hybrid ORs. $13,315. For example, problems can occur when a guide There is no national reporting system for RSIs, wire gets tangled around a stent and the wire but state and federal agencies along with accredi- fractures, leaving behind a small part of the wire, tation organizations have recommended action to or a subcutaneously placed catheter snaps upon prevent such events. removal and part of it is left interstitially. RSIs are considered a serious reportable event Device fragments can result from instrument (SRE) by the National Quality Forum and a senti- failure that develops from extensive use (burrs, nel event by The Joint Commission. The Centers loose parts) or faults in new instruments, such as for Medicare and Medicaid Services lists RSIs poor welds or rough surfaces. among the hospital-acquired conditions for which it will no longer provide payment under the Inpa- FDA takes notice tient Prospective Payment System. In 2008, the Food and Drug (FDA) Admin- The state of California in 2007 began mandat- istration issued a medical device safety alert ing that hospitals report cases of RSIs and other warning of serious adverse events associated SREs and levying administrative penalties in with UDFs and provided recommendations to cases where serious harm has occurred (www. mitigate these events (www.cdph.ca.gov/Pages/ cdph.ca.gov/Pages/NR13-005.aspx). NR13-005.aspx). In February 2013, the California Department of The FDA characterized a UDF as “a fragment Public Health (CDPH) issued penalties against 2 of a medical device that has separated unin- hospitals for RSI cases: tentionally and remains in the patient after the • One hospital was fined $100,000 for failing to procedure.” develop and implement a surgical count policy The FDA’s Center for Devices and Radiologic and procedure specifying that small items Health (CDRH) receives nearly 1,000 adverse would be accounted for prior to closure. A event reports each year related to these items. Raney clip was left inside a patient’s skull after Among the patient consequences of retention are: brain surgery. • local tissue reaction • Another hospital was fined $75,000 for leaving • infection behind a stiffener stylet (guide wire) from a • perforation or obstruction of blood vessels Groshong catheter. • death. Interestingly, these fines were for retained RSI-related safety notices on the FDA website small miscellaneous items and device fragments. reflect a range of consequences. For example, in ‘Surgical junk’ on the rise 1 safety notice, the FDA describes the fracture of the distal tip of an epicardial pacing lead. The The variety of small miscellaneous items tip was left in the patient without any adverse and unretrieved device fragments (UDFs) that consequences (www.fda.gov/MedicalDevices/ are being left in patients has increased, and Safety/AlertsandNotices/TipsandArticlesonDe- they are gaining attention, says Verna Gibbs, viceSafety/ucm203731.htm). In another instance, MD, who developed the NoThing Left Be- a fractured guide wire lodged in a coronary hind® project for RSI prevention (www.nothing artery during a cardiac catheterization, resulting leftbehind.org). in the patient’s death from cardiac tamponade

130 The OR Management Series Patient Safety in the OR (www.fda.gov/MedicalDevices/Safety/Alert- tial read in a significant number of cases,” says Dr sandNotices/TipsandArticlesonDeviceSafety/ Moffatt-Bruce. Seven of the 13 items were missed ucm070187.htm). on confirmatory postprocedural x-rays. Most of In addition, during MRI procedures, magnetic the retained items were found within 48 hours fields may cause metallic fragments to migrate, and were removed the same day. They were de- and radiofrequency fields may cause them to tected by means of interventional radiology pro- heat, which can lead to internal tissue damage cedures. Some items, however, were indwelling and burns. up to 6 weeks before being identified. “What’s important to point out about these “Though all of the patients did well, it is a miscellaneous small items and unretrieved device significant patient dissatisfier to have to undergo fragments is that physicians may not think they another invasive procedure,” she says. need to disclose to patients that they have left Strict adherence to protocols and stringent something behind if they decide not to take them radiographic review, along with standardized out,” says Dr Gibbs, professor of clinical surgery at team training, checklists, and documentation, are UCSF and a surgeon at the San Francisco Veterans needed to prevent these incidents. Affairs Medical Center. “This is bad practice,” she says. “Physicians Technology alone won’t work have a moral and ethical obligation to tell the Another of the penalties issued by CDPH in patient. It is important for the patient to know in February 2013 was a fine of $100,000 for a surgical case an MRI is needed in the future.” lap pad left in a patient despite the use of a 2-D matrix computer sponge counting device. Data show need for action Stanislaw Stawicki, MD, and Dr Moffatt-Bruce A 2012 study led by Susan Moffatt-Bruce, led a multicenter study to gain a better under- MD, PhD, chief quality and patient safety officer standing of why RSIs continue to occur, despite and associate professor of surgery at Ohio State the use of radiofrequency tagged sponges and University Wexner Medical Center in Columbus, wand systems and mandatory x-rays, and how to examined risk factors for intravascular retained reduce such events. small miscellaneous items and device fragments. One of the analyses combined data from 2 The retrospective study of 83 RSIs found that previously published case-controlled studies on 13 cases involved intravascular small miscel- RSIs (Gawande et al, 2003; Lincourt et al, 2007) laneous items and device fragments—8 guide with data from their study on 59 RSIs and 118 wires, 4 catheter/catheter fragments, and 1 coil. matched controls from 5 institutions gathered Locations included: over a 6-year period. • 3 catheter fragments were retained in the “Many variables that were not significantly pulmonary arterial tree. Of those, 1 broken associated with RSIs when data from the 2 catheter tip embolized into a distal pulmonary previous studies were combined became sig- arterial branch, and 2 catheter fragments were nificant when our data was added,” says Dr located in the heart. Stawicki, director of research for the division of • 1 guide wire was retained in the subclavian vein trauma/critical care and associate professor of surgery at Ohio State University Wexner Medi- • 2 guide wires were extending between the cal Center. heart and iliac vein Results showed that counts had been docu- • 2 guide wires were extending between the in- mented as correct in 45 of 59 cases, even though a ferior vena cava and the right atrium sponge was later found inside the patient. In 13 of • 3 guide wires were extending between the su- 27 cases an RSI was missed on initial confirmatory perior vena cava and the inferior vena cava x-rays. In 2 of 32 cases in which radiofrequency tagging systems were used, RSIs were missed. • 1 catheter and the coil were located peripher- The biggest risk, says Dr Moffatt-Bruce, is that ally in smaller vessels. humans are doing the operating and humans are Procedural factors significantly associated doing the counting. “Our goal is to minimize that with the retained intravascular items included: risk as much as possible through the adherence • technically difficult procedure—a procedure to and enforcement of a standardized process for that did not proceed as planned (ie, took more counting,” she says. than 1 attempt) “All technology does is layer on another • unfamiliarity with the equipment—new practice,” notes Dr Gibbs. “Humans are mak- equipment or equipment that did not work as ing errors in counting without technology, and expected or malfunctioned humans will continue to make mistakes with • difficult/emergent setting—a procedure done technology added.” emergently, often without enough time to go Dr Gibbs has been testing and teaching a through the usual safety steps, in a less than simplified, transparent standardized manual optimal environment. sponge management practice, called Sponge “One of the things we found was that radiol- ACCOUNTing System, which she says is being ogy under-reads, or the item is missed on the ini- used in hundreds of hospitals across the coun-

Patient Safety in the OR The OR Management Series 131 try. The practice requires the nurses to manage Dr Moffatt-Bruce notes that because of their the sponges only in multiples of 10 and to ac- study, Ohio State University Wexner Medical count for them at the end of the case rather than Center invested in team training through crew just count them. resource management. Some 38,000 staff have been trained. Teamwork, training essential Crew resource management speaks to the Each member of the OR team plays a part in basic premise of sharing the same mental model minimizing the risk of losing small miscellaneous in the OR, whether it’s during the procedure or items and generating UDFs, says Dr Gibbs. during the counts, she says. The model makes the • Surgical technologists should inspect any de- surgeon responsible for doing the timeout as well vice before handing it to the surgeon and again as the debriefing at the end of the case to ensure when it is passed back after use. nothing is left behind. ❖ • Surgeons should perform a methodical wound —Judith M. Mathias, MA, RN exam before closing every wound. References • Circulating nurses should direct the activities Ergova N N, Moskowitz A, Gelijns A, et al. Manag- to account for all 4 classes of surgical items— ing the prevention of retained surgical instru- soft goods (eg, sponges, towels), sharps (eg, ments: What is the value of counting? Ann Surg. needles, blades), instruments, and small mis- 2008;247:13-18. cellaneous items and device fragments. Gawande A A, Studdert D M, Orav E J. Risk factors Dr Gibbs says she would like to see a check- for retained instruments and sponges after sur- box added to nursing operative records to sig- gery. N Engl J Med. 2003;348:229-235. nify a correct count of all small miscellaneous Gibbs V. A surgical junkyard. CHPSO Patient Safe- items. Currently nurses are bundling small mis- ty News. 2011;3:1. cellaneous items either with sharps or instrument counts. Lincourt A, Harrell A, Cristiano J, et al. Retained In cath labs and procedural areas, procedur- foreign bodies after surgery. J Surg Res. alists have to develop and adopt practices to 2007;138:170-174. account for all surgical items at the end of the Mehtsum W T, Ibrahim A M, Diener-West M, et al. procedure. One example would be to have a Surgical never events in the United States. Sur- memory aid added to the central line-associated gery. 2013; 153:465-472. bloodstream infection (CLABSI) procedure list to Moffatt-Bruce S D, Ellison E C, Anderson H L, visually confirm that the guide wire is in the kit at et al. Intravascular retained surgical items: A the end of the insertion. This would ensure that it multicenter study of risk factors. J Surg Res. wasn’t inadvertently left in the patient. 2012;178:519-523. “Instead of trying to assess the risk of an RSI based on the type of case or characteristics of the Rowlands A, Steeves R. Incorrect surgical counts: A qualitative analysis. AORN J. 2010;92:410-419. patient,” says Dr Gibbs, “it would be better to look at the risk of the providers performing and Stawicki S P A, Moffatt-Bruce S D, Ahmed H M, et assisting with the surgical procedures. The risk is al. Retained surgical items: A problem yet to be in the personnel and the environment in which solved. J Am Coll Surg. 2013;216:15-22. they work. Zhan C, Miller M R. Excess length of stay, “An RSI means the OR team has poor practices charges, and mortality attributable to medi- and is not working together. I call an RSI case a cal injuries during hospitalization. JAMA. canary in the surgical coal mine,” she says. 2003;290:1868-1874. A lot has been learned from wrong-site surgery, says Dr Gibbs. By implementing timeouts and using checklists, OR staff began to standardize practice, communicate, and work together. This article originally appeared in OR Manager, Similar systems are needed for prevention of RSIs. July 2013;29:1, 10-12.

132 The OR Management Series Patient Safety in the OR VII. Wrong Patient, Wrong Surgery, Wrong Site

Patient Safety in the OR The OR Management Series 133 A clearer, more robust surgical consent process

large Chicago-area health system has built • The consent information is verified with the a clearer, more robust process for resolving patient during the preop phone call, again on Aany discrepancies in the surgical consent admission, and again with the patient during prior to the day of surgery. Consent discrepancies the surgical site marking. are a risk factor for wrong-site surgery. • Abbreviations were reviewed to make sure “We realized that by the time the patient arrives they were standardized and added to the list in the surgery area, it is too late. Most of the work of those approved. Some, such as TLIF (trans- is done preoperatively,” says Beverly Beine, BSN, foraminal lumbar interbody fusion), were sent MS, RN, NE-BC, vice president for perioperative to the health information management depart- services, for Evanston, Illinois-based NorthShore ment for approval. University HealthSystem, which has 4 hospitals • On the day of surgery, patients are not taken to and performs about 40,000 procedures a year. the procedural area until any discrepancies in After a couple of near misses in opththalmol- presurgical documents are resolved. ogy, a team of nurses began working on a quality improvement project to ensure consistency During the Universal Protocol to verify the among the signed consent, the surgical schedule, patient’s surgical site before the procedure, the and the surgeon’s update note. team checks again to make sure the consent order “We looked at the whole process—what were matches the OR schedule and the surgeon’s up- the key failure points?” she says. date note. Surgical scheduling is centralized for all 4 hos- “If those 3 elements are not consistent, we stop pitals. Scheduling requests are called in, faxed, or the process,” Beine says. “Phone calls are made, for some offices, scheduled via computer. A chal- and the information is clarified until we have the lenge is that consents do not follow a standard correct information.” workflow. Some offices submit them via Epic, A learning curve the health system’s electronic health record. Oth- As with any process change, there was a learn- ers fax the forms. Or patients bring them to their ing curve. NorthShore has a number of midlevel preop appointment. providers, such as PAs, who work with the sur- After the QI project was completed and chang- geons in preparing patients for surgery. es introduced, within a year, consent discrepan- The Surgical Quality Committee was instru- cies fell from about 8% of cases to about 0.3%. mental in getting the buy-in of surgeons because A refined process they analyze near misses as part of the peer re- Among the changes in the consent policy: view process. “They got the information out,” she says. “We • Consents for elective procedures must be re- shared it with the staff so they would understand ceived in the preop area at least 24 hours be- why we were doing this.” fore surgery. The administration supported the decision • The attending surgeon, not the physician as- not to take patients to the procedural area until sistant (PA), must either obtain the patient’s discrepancies are resolved. consent or enter the consent order in Epic. Though there are still some challenges, Beine Using Epic, which all surgeons’ offices can says, “At this point, I don’t believe the surgeons access either directly or through a web portal, would want to go back. It’s becoming part of their surgeons can enter the consent order as soon as workflow.” the patient encounter is completed and append it She adds: “The focus really is on creating a cul- to the patient’s record. When the patient arrives ture of safety. We drove that message home with for surgery, the consent order is released, and the surgeons, anesthesia, and the OR staff.” ❖ the nurse can perform the formality of having the —Pat Patterson patient sign the consent form. “We are seeing some surgeons doing them more than 24 hours in advance, which is good,” This article originally appeared in OR Manager, Beine says. April 2012;28:20.

134 The OR Management Series Patient Safety in the OR ‘Just Culture’ encourages error reporting, improves patient safety

uring a procedure in the OR, a medication In recent years, perioperative services in the is retrieved from the automated supply Southcoast Hospitals Group has evolved into a Dstation and introduced onto the sterile Just Culture. Southcoast has adopted a defini- field. The sterile field is then, unknowingly and tion of Just Culture based on the description unintentionally, contaminated by an unsterile by David Marx, JD, the safety engineer who medication. developed the concept: “Our culture is an en- This example could happen in any operating vironment that encourages reporting and puts room setting. In this case, the circulating nurse a high value on open communication—where spoke up and brought the situation to the at- risks are openly discussed between managers tention of the manager, providing a learning and staff. We create an environment where staff opportunity for herself and her peers. An im- members feel safe and supported in voicing con- mediate survey within the department revealed cerns, while also holding them accountable for that the majority of nurses would not have behaviors and practice. We learn from mistakes questioned if the contents of a medication or and strive to improve processes, recognizing that solution from the supply station could possibly good outcomes are a result of a shared account- be nonsterile. Often, the packaging with this ability for both good system design and personal information is removed before a medication is responsibility.” placed in the machine. With the change in leadership structure and This incident illustrates how a “Just Culture” the addition of a new nursing director 5 years practice environment, in which an organization’s ago came a leadership philosophy of open com- leadership embraces a systems approach to error munication and transparency regarding the reporting, results in safer patient care. Research reporting of both errors and near misses. It was demonstrates that the root causes of most errors a new concept for the OR staff. Unlike many in health care systems are organizational issues. other organizations, errors didn’t often surface Still, it is common for management to blame because of a lack of reporting by members of individuals when errors occur. This blaming the care team. approach leads to missed opportunities to learn To introduce the Just Culture approach and from the error, to better educate clinicians about hardwire it throughout perioperative services, their practice and situational awareness, and to the perioperative director adopted a hands-on improve systems and processes to help prevent strategy with her leadership team. When an future errors. As Lucian Leape, MD, a leader in unsafe incident occurred, the director closely the prevention of health care errors, states, “The mentored managers throughout the process of single greatest impediment to error prevention reporting and resolving the issue. As a guide, is that we punish people for making mistakes.” they use the Unsafe Acts Algorithm as a consistent framework to explore each occurrence. The algorithm, adapted from James Reason’s Safer Surgery series research on errors in complex, high-risk areas, provides an objective tool that embeds the fol- This series of articles covers Ten Elements lowing elements: for Safer Surgery developed by Advocate • intent to harm Health Care, a 10-hospital system in the • incapacity Chicago area. • foresight Previous articles in the series focused on: • the “substitution test.” • OR governance: January 2013 The substitution test involves substituting • Safer surgical scheduling: February 2013 the individual(s) involved in the incident with • Presurgical assessment: March 2013 a peer from the same clinical domain with • Excellence in sterile processing: April 2013 similar experience and skills and asking how • Checklists: May 2013 the peer would deal with the situation. This • Daily huddle: June 2013. test was useful in the example involving the automated supply station because it showed

Patient Safety in the OR The OR Management Series 135 4. Pass substitution test? Would another individual coming from the same professional group 1. Were the No No 3. Knowingly No Yes 5. Recent history 2. Substance violated possessing of unsafe acts or actions comparable as intended? use? safe operating unintentional procedures? qualifications and rule breaking? experience behave in the same way under similar circumstances?

Yes No Yes Yes No No

Were policies Were the and procedures Deficiencies in Blameless error. consequences Prescribed? available, training and Employee assists as intended? workable, section or in process intelligible, inexperienced? improvement. No and correct? No No

Possible negligent Substance System-induced behavior. abuse without violation. Investigation, mitigation. Employee possible counseling, Yes Yes Yes Follow Yes assists Yes suspension, Substance in process termination. Refer Abuse Policy. improvement. to Corrective Action Policy.

Human error. Develop Intentional rule Possible reckless remedial and/or breaking. Substance abuse violation. Initiate corrective action plan. with mitigation. corrective action System-induced Investigate; error. Employee Document verbal initiate corrective Engage employee process if counseling and assign assistance and indicated assists in process action if indicated improvement. a preceptor/mentor to per Corrective follow Substance per Corrective work with the employee. Action Policy. Abuse Policy. Action Policy. Refer to Corrective Action Policy.

Reprinted with permission from Reason J. Managing the Risks of Organizational Accidents. Farnham UK: Ashgate, 1997, and Roesler R, Ward D, Short M. Supporting staff recovery and reintegration after a critical incident resulting in infant death. Adv Neonatal Care. 2009;9:163-171.

that someone else faced with the same situa- with the error-reporting process. This includes tion clearly could have done the same thing. co-managing investigations and following Using the substitution test helps to identify through all of the steps. This process facilitates whether there are deficiencies in the system or navigating the investigation through possible staff education. contributing factors such as human error, at-risk The algorithm is part of the standard ap- behavior, or reckless behavior. Outcomes of this proach to error management at Southcoast. process range from consoling the staff member There is a formal electronic reporting system, to coaching or reprimand. which staff members use to document any Managers continue to consult with their di- safety concern they observe or in which they are rector and peers when incidents occur to gain involved. The incident reporting system allows insights and to learn from one another. When the person completing the report to forward talking with staff, managers use an empathetic the message to appropriate managers or direc- and blameless communication style and avoid a tors, including physician leadership, who are potentially punitive tone. Often, the staff mem- needed to complete the investigation. It is an bers who are involved are encouraged to develop interactive system that fosters communication their own collaborative solutions and improve- and collaboration around the event. The risk ments, which are then shared (anonymously, if management department views all incidents in warranted) with the entire team. the system. In addition, staff can and often do The Southcoast Hospital Group’s perioperative talk directly with their manager. The manager leadership team meets monthly as a group, and then uses the algorithm to explore the incident, the agenda always includes a discussion about in- the root cause, and possible courses of action cidents that have occurred throughout the system. that may be needed. This allows for broad-based learning from team New managers are coached by the director members, another facet of the open and transpar- until the manager is skilled and comfortable ent culture that has emerged over time.

136 The OR Management Series Patient Safety in the OR Just Culture doesn’t replace individual ac- Marx D, Comden S C, Sexhus Z. Our inaugural countability for safe practice; rather, it encour- issue—in recognition of a growing community. ages management to focus on system and organi- Just Culture Community News and Views. Novem- zational contributions to patient safety incidents. ber/December. 2005;1:1. Integral to the success of this approach is the Meadows S, Baker K, Butler J. Incident decision support of leadership, the human resources de- tree: Guidelines for action following patient partment, and the medical staff. The outcomes safety incidents. Advances in Patient Safety: of the Just Culture include stronger teamwork, From Research to Implementation, Vol 4, pp increased reporting, a change in culture, and 387-399. Washington, DC: Agency for Health- ultimately a safer practice environment. care Research and Quality, 2005. www.ncbi. —Deborah Rideout, BSN, RN, CNOR, is director nlm.nih.gov/books/NBK20446/?redirect-on- error=__HOME__ of perioperative services, Southcoast Hospitals Group, New Bedford, Massachusetts. Reason J. Managing the Risks of Organizational Ac- cidents. Farnham UK: Ashgate, 1997. For more about Just Culture, visit the Just Cul- ture Community at www.justculture.org.

References Marx D. Patient Safety and the “Just Culture”: A This article originally appeared in OR Manager, Primer for Health Care Executives. New York: Columbia University, 2001. July 2013;29:13-15.

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