The monthly publication for OR decision makers

August 2011 Vol 27, No 8

OR communication Time to tone it down: Strategies ASC section on page 26 for managing noise, distractions ur society has become a and potentially increases the risk In this issue “ lot louder, and we tol- of error.” The statement calls for TECHNOLOGY FOR SURGERY Oerate a lot more noise,” a team effort to reduce noise. OR A critical eye on says Verna Gibbs, MD, director of management teams need to un- Infuse use studies...... 5 NoThing Left Behind and profes- derstand the danger of noise and sor of clinical surgery, University strategies for reducing it. PATIENT SAFETY of California, San Francisco. That Pinpointing risks of includes the OR, where phones, The danger of noise wrong surgery...... 7 overhead pages, alarms, suction, Noise poses several threats: hear- ventilation equipment, medical ing loss, negative physiologic Hardwiring the right- devices such as drills, electronic changes such as increased cortisol site process...... 9 music devices, conversation (both levels, patient and family anxiety, essential and extraneous), and and distraction. INFECTION CONTROL much more push noise levels Yet, often not enough is done What to do for vaginal prep... 19 higher. to dispel those threats according The AORN position statement, to Michael H. Fritsch, MD, FACS, GI ENDOSCOPY Noise in the Perioperative Setting, who has studied the issue. “You What’s new in endoscopy recognizes that noise is “a distrac- need to recognize you have a guidelines?...... 22 tion that interrupts patient care Continued on page 12

PATIENT SAFETY Patient safety A new perspective on OR time-out...... 24 Devil in details: Identifying defects MANAGING TODAY’S OR that could lead to a wrong surgery SUITE A call to self-care, reflection, he devil really is in the de- “Unless you’ve studied your and renewal...... 25 tails. That’s a key message own process, you’re flying blind,” Tfrom a national project to said Mark Chassin, MD, the Joint AMBULATORY SURGERY prevent wrong-site surgery. Five Commission’s president, in a CENTERS hospitals and three surgery cen- press call. What are your ASC’s ters have worked with the Joint The eight facilities measured security gaps?...... 26 Commission’s Center for Trans- their defects in each phase of forming Healthcare (CTH) to the process: surgical scheduling, A Special Supplement measure defects in their own pro- preop/holding area, and the op- from ECRI Institute cesses and come up with targeted erating room. Participants then Rapid methicillin-resistant ways to reduce the defects and developed improvement strate- Staphlococcus aureus (MRSA) thus the risks of a wrong surgery. gies and measured again to see if screening in infection Findings were reported June 29, these reduced the defects. control programs...... 15 2011. Two participants, AnMed Defects differ in each organiza- Health, Anderson, South Caro- tion. Continued on page 6 No travel required. You don’t need to get on the plane, train, or bus.

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18780

18780 OR Webinar ad_full.indd 1 4/18/11 3:18:46 PM Editorial

We all think we are good at www.ormanager.com multitasking—but we’re really PUBLISHER Elinor S. Schrader not. A good way to enhance deci- “ EDITOR sion-making is to sleep on it. Exer- Do you know Pat Patterson • 303-756-0579 • [email protected] cise boosts brain power and could CLINICAL EDITOR Judith M. Mathias, MA, RN stave off Alzheimer’s. these EDUCATION COORDINATOR These are a few of 12 “brain Judy Dahle, MS, MSG, RN ‘brain rules’? CONSULTING EDITOR rules” laid out by writer John Me- Kathleen Miller, MSHA, RN, CNOR dina in his fascinating book of the CONTRIBUTING WRITER Paula DeJohn same name. Medina, a developmental mo- “ lecular biologist, translates the dis- Stress in the OR is inescapable. coveries of neuroscience into an A critical factor in fighting stress SENIOR VP/GROUP PUBLISHER DORLAND HEALTH/MEDIA/COMMUNICATIONS easy-to-digest book with food for is to feel in control. Managers can Diane Schwartz • 212-621-4964 • [email protected] thought for any manager, teacher, help, Medina suggests. Identify ASSOCIATE PUBLISHER Carol Brault • 301-354-1763 • [email protected] or parent. situations where the staff feels TRADE SHOW DIRECTOR He’s a gifted teacher and story most helpless and help them build Jenn Heinold teller. competence to master them. ART DIRECTOR David Whitcher The rules are principles we’ve Brain Rules has advice to help SENIOR PRODUCTION MANAGER probably all read about. The book leaders be better teachers, many of Joann M. Fato • 301-354-1681 • [email protected] ties them together with readable them no doubt familiar: You have Advertising explanations of the underlying bi- seconds to grab someone’s atten- National Advertising Manager John R. Schmus ology and biochemistry. tion and only ten minutes to keep Anthony J. Jannetti, Inc. it. Beware the wordy PowerPoint. East Holly Ave/Box 56, Pitman, NJ 08071 Tel: 856-256-2300; Fax: 856-589-7463 A few brain rules Think visual. Email: [email protected] A sampling of the rules: This book is chock full of infor- REPRINTS • When we try to multitask, the mation about brain science. Yet it Wright’s Media brain goes through four steps manages to teach without being 877-652-5295 • [email protected] to change a task, and they have academic or tedious. Medina gives Vol. 27, No. 8, August 2011 • OR Manager (ISSN 8756- 8047) is published monthly by Access Intelligence, LLC. to be done in sequence. Stud- you a new appreciation for what Periodicals postage paid at Rockville, MD and additional post offices. POSTMASTER: Send address changes to OR ies show a person who is inter- goes on in your own mind and Manager, 4 Choke Cherry Road, 2nd Floor, Rockville, MD 20850. Subscription rates: Print only: domestic $99 per rupted takes 50% longer to ac- those of the people around you. It year; Canadian $119 per year; foreign $139 per year. Super complish a task and makes up gives you a deeper understanding subscriptions (includes electronic issue and weekly elec- tronic bulletins): domestic $149 per year; Canadian $169 to 50% more errors. of why people behave and learn per year; foreign $179 per year. Single issues $24.95. For subscription inquiries or change of address, contact Client • To improve your thinking skills, as they do. Services, [email protected]. Tel: 888-707-5814, move. Our brain still craves For all of the science it con- Fax: 301-309-3847. Copyright © 2011 by Access Intel- ligence, LLC. All rights reserved. No part of this publication doing what humans did eons veys, it is characterized by an un- may be reproduced without written permission. ago—walking, running, explor- abashed sense of wonder at the OR Manager is indexed in the Cumulative Index to Nursing and Allied Health Literature and MEDLINE/PubMed. ing. Maybe we should do our human brain and its amazing SISTER Sites reading on the treadmill! complexity and capabilities. dorlandhealth.com patientadvocatetraining.com • What you do and learn in life contexomedia.com physically changes your brain— No time to read? Access Intelligence, LLC it literally rewires it. No two Medina follows his own advice Chief Executive Officer Don Pazour people’s brains store the same about visual learning. His engag- Executive Vice President & Chief Financial Officer information in the same place. ing website covers all 12 rules with Ed Pinedo Exec. Vice President, Human Resources & Administration • Sleep cements learning and leads videos and colorful charts. An Macy L. Fecto Divisional President, Access Intelligence to better decisions. Sleeping is audio book and DVD are available. Heather Farley Senior Vice President, Chief Information Officer especially helpful when learning Brain Rules is a great resource Robert Paciorek a new procedure—good advice to share with your leadership Senior VP, Corporate Audience Development Sylvia Sierra for perioperative orientees. team—especially the sections on Vice President, Production and Manufacturing Michael Kraus • Stress hurts learning. And stress attention, stress, and sleep. ❖ Vice President, Financial Planning and Internal Audit hurts people. Stress hormones —Pat Patterson Steve Barber Vice President/Corporate Controller from chronic stress can do nasty Learn more about Brain Rules at Gerald Stasko 4 Choke Cherry Road, Second Floor things to the brain. www.brainrules.net. Rockville, MD 20850 • www.accessintel.com

August 2011 OR Manager Vol 27, No 8 3 We’ve got your OR Manager webinars on record.

If you missed one of our webinars you can still get the recording. You and your staff can access it for 30 days.

Here are some of the best-selling webinars:

• Clinical Guidance on Surgical Fire Prevention and Management • Strategic Planning for OR Leaders • The OR Business Manager’s Role in Perioperative Services • The Business Case for ‘Flipping’ in the OR • Surgery Scheduling: A Critical Element for Patient Flow • Creating an Effective Preop Program

Check out the complete listing of OR Manager webinars on our website, www.ormanager.com Technology for surgery A critical eye on Infuse use studies leading spine journal is 13 original industry-sponsored casting a critical eye on in- studies, led by Spine Journal’s edi- Adustry-supported research “ tor in chief, Eugene J. Carragee, that has led to widespread use of Early studies MD, finds the articles did not re- Medtronic’s controversial bone port a single adverse event. Yet growth product Infuse. The June didn’t report FDA documents and subsequent 2011 issue of Spine Journal carries complications. studies found complication rates a strongly worded editorial about and adverse events 10 to 50 times the trial designs, reporting bias, the original estimates. and peer review shortfalls that the Also in the issue, a clinical authors say have promoted the “ study disputes a frequent justifica- product’s widespread use, with protein (BMP-2), approved by the tion for using BMP-2, less pain by “eventual life-threatening compli- Food and Drug Administration avoiding harvest of the patient’s cations and deaths.” (FDA) in 2002 for limited applica- own bone. The study disputes The editorial says early studies tion, is widely used in spinal sur- the severity and frequency of this underestimated risks of BMP-2, gery to induce bone growth. An problem, placing it in perspective even though there were indica- estimated 30% to 50% of fusions of the general pain patients have tions of a number of complica- used BMP-2 in 2007. after lumbar fusion. tions like inflammatory reactions, Despite the growing list of com- Other studies highlight effects of radiculitis, retrograde ejaculation, plications, BMP-2 may still be of BMP-2 on the central and periph- urinary retention, and bone re- great benefit to a small group of pa- eral nervous system and look at sorption. tients who have serious bone heal- osteolysis, a common side-effect. Some authors of these early ing problems, writes one of the edi- trials had financial ties with tors, Christopher M. Bono, MD. ‘Choirboy defense’ Medtronic in amounts ranging to The issue includes reviews of The editorial takes to task the more than $26 million per study, the early research plus clinical “choirboy defense” among spine the editorial notes. studies and commentaries. surgeons who contend the profes- Infuse, or bone morphogenic A critical 21-page review of the sion is honest, has “unimpeachable integrity,” and conflicts of interest that are only “potential.” “Outside the echo chamber,” the Advisory Board authors say, “much of this rhetoric

Mark E. Bruley, EIT, CCE Lisa Morrissey, MBA, RN, CNOR fails to pass the test of minimum Vice president of accident & forensic Nursing director, Main OR Massachusetts credibility. investigation, ECRI, Plymouth Meeting, General Hospital, Boston, Massachusetts “We find ourselves at a precari- Pennsylvania Shannon Oriola, RN, CIC, COHN ous intersection of professional- Stephanie S. Davis, MSHA, RN, CNOR Lead infection control practitioner, Sharp Assistant vice president of surgical services Metropolitan Medical Campus, San Diego ism, morality, and public safety,” Hospital Corporation of America, Nash- John Rosing, MHA, FACHE say the editorial writers, noting ville, Tennessee Vice president and principal, Patton that spine surgery now “operates Reuben J. DeKastle, BN, MSHA, RN, CNOR Healthcare Consulting, Milwaukee, Wisconsin under a burden of suspicion.” Clinical educator, Main OR St Luke’s Martha Stratton, MSN, MHSA, RN, CNOR, Boise, Boise, Idaho NEA-BC Director of nursing, surgical The journal’s editors pledge Franklin Dexter, MD, PhD services AnMed Health, Anderson, South to make changes in editorial pol- Professor, Department of anesthesia and Carolina icy that they hope will achieve a health management policy, University of Cynthia Taylor, BSN, MSA, RN, CGRN Iowa, Iowa City Nurse manager, endoscopy & bronchos- better balance in critical manu- Lorna Eberle, BSN, RN, CNOR copy units, Hunter Holmes McGuire VA script review, conflict of interest Director, perioperative services Providence Medical Center, Richmond, Virginia disclosure, and publication pre- St Peter Hospital, Olympia, Washington Terry Wooten, Director, business & material Jerry W. Henderson, MBA, RN, CNOR, resources, surgical services & endoscopy, sentation. CASC Assistant vice president, periopera- St Joseph Hospital, Orange, California Spine Journal is published by the tive services Sinai Hospital, Baltimore, David E. Young, MD North American Spine Society. ❖ Maryland Medical director, perioperative services Kathleen F. Miller, MSHA, RN, CNOR Advocate Lutheran General Hospital, Park President, senior consultant, PeriopRx Ridge, Illinois A news release with links to the ar- Consultants, Gilbert, Arizona ticles is at www.spine.org.

August 2011 OR Manager Vol 27, No 8 5 Patient safety

Continued from page 1 Operating room lina, and Rhode Island Hospital, Cases with defects in the OR fell Providence, tell about their proj- “ from the baseline of 59% to 29%. ects in this issue. Scheduling is Some defects identified: • Site marking used an unap- Targeted solutions a major source proved marking pen that Key interventions will be pilot- of defects. washed off, the mark was not tested in more facilities. Then this visible after prep and drape, fall, CTH plans to post the tested every procedure was not strategies on its website in a Tar- “ marked, and team members did geted Solutions Tool, available not reference the site. to accredited organizations. The their overall per-case defect rate • Critical elements of the time- electronic tool, which Dr Chassin from 39% to 21%. Among defects: out were not voiced, such as the said will be simple to use, will • Written booking forms were patient name, second identifier, walk facilities through what the 8 not being received, resulting in procedure, site, and laterality. participants did to measure their verbal bookings or last-minute • Staff were rushed during the risks and to see whether they have scheduling. time-out, and critical steps are these risks themselves. • Bookings were incorrect or in- missed. He said CTH anticipates hav- complete. Laterality was not Example of solution: Script the ing data by then on whether the addressed, procedure descrip- time-out so the process is consis- risks can be lowered further and tions and codes were inconsis- tent, and all steps are covered. the results sustained. That could tent, and there were problems Audit for compliance. include data on whether organi- with legibility and use of unap- A major take-home from the zations can achieve 90% of cases proved abbreviations. project: Each organization needs or more with no measured risks. An example of a solution: Stan- to measure its own defects to dardizing the information used understand where its risks lie No change to Universal for scheduling cases, including and then take targeted steps to Protocol specific ways to identify the pa- address those defects. ❖ Will changes in the Universal Pro- tient and exactly what procedure tocol result from the project? will be performed. Participating organizations were: “Right now, we don’t see any AnMed Health, Anderson, South Car- reason for changing the compo- Preop/holding area olina; Center Health Ambulatory Sur- nents of the Universal Protocol,” A variety of defects with docu- gery Center, Peoria, Illinois; Holy Spirit Dr Chassin said, noting that it’s ments and verification were iden- Hospital, Camp Hill, Pennsylvania; La possible the commission might tified in the preop and holding Veta Surgical Center, Orange, California; want to refine the protocol later. areas. Fixing these brought de- Lifespan-Rhode Island Hospital, Provi- The principles of the Univer- fects down from 52% to 19%. The dence, Rhode Island; Mount Sinai Medi- sal Protocol work, he added. The incidence of cases with more than cal Center, New York City; Seven Hills problem is in applying the prin- one error fell by 72%. Surgery Center, Henderson, Nevada; and ciples. “What we found is that Among the defects were: Thomas Jefferson University Hospitals, individual organizations need to • Incomplete, incorrect, or miss- Philadelphia. specify exactly how they will be ing documents such as the his- carried out”; that is, exactly how tory and physical, consent, and More on the wrong-site surgery proj- to do the site marking, the verifi- OR schedule. ect is at www.centerfortransform- cation, and the time-out. • Lack of verification of patient’s inghealthcare.org. Here’s a look at what the proj- name and second identifier, ect has found so far. procedure, site, and laterality. • Changes to the consent in the Friend OR Manager Surgical scheduling preop area without notifying on Facebook! Scheduling turned out to be a the OR. major source of defects that could An example of a solution: Con- Look for the latest developments lead to a wrong surgery. By ad- firm that all primary documents and the news behind the news for dressing scheduling problems, are present and accurate before OR leaders. participants were able to reduce the day of surgery.

6 OR Manager Vol 27, No 8 August 2011 Patient safety Pinpointing risks of wrong surgery o you know where your “We made a lot of the fields for OR’s process is at most patient data required,” she notes, Drisk for an error that could “ solving the problem of missing lead to wrong-site surgery? Where is the information. In many ways, she A South Carolina health sys- says, electronic scheduling is eas- tem identified its improvement process most ier for the offices because they can opportunities and came up with vulnerable? schedule on their own time rather solutions as part of a national than having to call while the pa- project with tient is in the office. the Joint Another improvement is a new Commission “ scheduling manual that helps of- Center for them over the past few months. fices to better prepare patients for Transform- “When we looked at our data, surgery and their preop assess- ing Health- we decided to start where the pa- ment appointments. care (CTH). tient actually starts, in the phy- “We found a lot of offices Five hos- sician’s office where the case is didn’t know what we needed to p i t a l s a n d posted. We made major changes schedule surgery,” Rush says. three ambulatory surgery centers in our scheduling process,” says For example, if offices know participated in the project, with Martha Rush, BSN, RN, CNOR, the hospital needs the consent, findings announced in June 2011 nurse manager for women’s and history and physical, and other (related article). children’s surgery, postanesthesia paperwork, fewer phone calls Working with CTH, AnMed care, and endoscopy. will be needed to retrieve miss- Health of Anderson, South Caro- ing information. The manual in- lina, focused on four areas: Physicians’ office cludes: • surgical scheduling The phone- and paper-based • the scheduling policy • Surgery Assessment Center scheduling process was one issue • key phone and fax numbers (SAC) the project team identified. Data • information needed to schedule • preoperative/holding area showed nearly half of paper- a patient for surgery • operating room. work errors were due to cross- • what patients need to bring to AnMed Health performs about throughs or mark-outs on faxed the assessment appointment. 10,000 surgical procedures a year scheduling forms, and 27% were at its 460-bed medical center and due to more than one form being Surgery assessment center 72-bed women’s and children’s received. Plus, with phone calls, Among areas identified for im- hospital. there’s no tracking mechanism provement were incorrect or to review what was said, Rush missing documents or the sched- Project phases observes. uled procedure not matching the The project was conducted in The solution—go electronic. physician’s orders. To ease com- three phases: In a pilot, three surgeons’ of- munication and reduce phone • data collection fices have been brought online so calls, the scheduling office was • data analysis to identify oppor- they can post cases directly into moved to the surgery assessment tunities for improvement the hospital’s surgical schedul- center (SAC). Previously, the two • identification and implementa- ing system, where they are able staffs spent a lot of time on the tion of solutions. to view and post only to their por- phone requesting information Aided by CTH consultants, tion of the schedule. from each other. AnMed Health collected about The rest of the surgeons’ prac- “It has integrated both of the five weeks’ worth of data on tices will be brought on line, start- staffs and helped the flow of com- all of its surgical patients using ing with those that AnMed Health munication,” Rush says. “We felt data collection tools it helped to owns and moving out to the rest. that once we had this in place, design. The analysis turned up AnMed Health provides the soft- some of the issues we faced vulnerabilities in each area. In ware and training. downstream would take care of response, teams identified so- So far, Rush says it’s been a themselves.” lutions and have been piloting success. Continued on page 8

August 2011 OR Manager Vol 27, No 8 7 Patient safety

Health Organization (WHO) Sur- Safe Surgery 2015 gical Safety Checklist. It’s estimated that 20% of US “ A physician champion, Paul hospitals are using the World Offices are Frassinelli, MD, “has been instru- Health Organization (WHO) scheduling mental in helping us know what Surgical Safety Checklist, the surgeons are interested in according to surgeon Atul online. when they do a time-out,” Rush Gawande, MD, MPH, of Har- says. Nurses have been involved vard. The checklist’s originator, through the OR’s unit council, Dr Gawande is director of the “ part of its shared governance Safe Surgery 2015 initiative and structure. “This is probably the WHO’s global campaign to re- Two solutions identified were first time surgeons and nurses duce surgical deaths. to: have come to the table together on Safety Surgery 2015 is part- • standardize site marking this,” she says. nering with the South Carolina • consider marking all sites re- The updated checklist is under Hospital Association to intro- gardless of whether they in- review by medical staff commit- duce the checklist in every OR volve laterality. tees. Once approved, it will be in the state. The project then As it was, surgeons were using rolled out with education for the plans to roll out nationwide. a variety of types of marks with- staff. The final checklist will be Some 80% of South Carolina out standardization. The vice enlarged, laminated, and posted hospitals have already tested president and director of medi- in each OR so all team members the checklist, the association cal affairs are working with the can see the prompts. says, and many more have ad- surgeons to standardize the site The effort has received a boost opted it as a routine. marking. from the state’s Safe Surgery 2015 A pilot study published in AnMed Health is also consider- initiative, which aims to introduce 2009 in the New England Journal ing marking all sites, regardless of the WHO Checklist in all South of Medicine demonstrated that laterality, which the CTH consul- Carolina hospitals (sidebar). The with use of the WHO checklist tants suggested. initiative has raised the checklist’s in eight hospitals worldwide, visibility among physicians. major complications and inpa- Operating room tient deaths following major Data collection showed several vul- Success factors surgery declined. nerabilities in the time-out process Rush says one of the biggest suc- in the OR. Leading factors were: cesses so far “is getting a physician • The person leading the time- champion to take the checklist and Tools for introducing and out wasn’t reading all of the pa- be passionate about why we need using the checklist are at tient’s identifying information, it and the exact meaning of it.” www.safesurgery2015.org particularly the medical record Electronic scheduling is another number. win. Capturing demographic in- Continued from page 7 • Team members weren’t ceasing formation electronically makes Preoperative/holding areas conversations during the time- scheduling more accurate. Once Opportunities for improvement out. schedulers get the information, for the preoperative and holding AnMed Health is evaluating its they can link it through the hospi- areas were the consent not match- choice of the two unique patient tal’s ADT (admission, discharge, ing the schedule or not matching identifiers and considering other and transfer) system directly into the orders as well as abbreviations options. The patient’s name and the patient documentation. “We and incorrect laterality. date of birth are cited by the Joint have needed few phone calls back To fix the consent issue, the Commission as the most common to the surgeons’ offices to confirm process was changed so that at identifiers used. information.” the time of the patient’s assess- The project has been about ment visit, the consent is checked Surgical checklist “making it a safer journey for against the procedure scheduled Surgeons and nurses have par- the patient and helping us to re- and with the physician’s orders ticipated in strengthening use of alize the points that are error- and documented as part of the the OR’s surgical safety checklist, prone.” ❖ assessment. a modified version of the World —Pat Patterson

8 OR Manager Vol 27, No 8 August 2011 Patient safety Hardwiring the right-site process or the past four years, Rhode celled. To be complete, the chart Island Hospital (RIH) in must contain 3 primary docu- FProvidence has reviewed its “ ments, with all in agreement: the processes for preventing wrong- Lack of focus history and physical, the consent, site surgery from top to bottom. and the booking slip. The hospital has been under the was an essential microscope after several widely finding. Hardwiring the OR process publicized incidents dating back Among other changes in the to 2007. The hospital has been preop process: fined by the state and successfully • The surgeon must see the patient passed a two-week review by the “ in the preop area on the day of Centers for Medicare and Medic- • conducted a failure mode and surgery and initial the surgical aid Services in late 2010. effects analysis (FMEA) that site. Through it all, RIH has been identified 213 potential failure • In the preop area, the surgeon open about its challenges and ef- points, of which they focused on and a nurse together identify the forts to correct them. the top 10 from the preoperative patient and review the primary With its sister facility, Newport area and the OR documents. Hospital, RIH was the first to sign • trended and analyzed data with • If the surgeon is unable to mark on to a national project for pre- outside experts as part of the the site, the surgeon must docu- venting wrong-site surgery led by CTH project. ment why the site is not being the Joint Commission’s Center for Dr Marcaccio, an active sur- marked. This rationale must be Transforming Healthcare (CTH). geon, has worked closely with the discussed with other providers Findings were rolled out in June physicians. throughout the perioperative 2011 (related article). They both acknowledge the continuum. “We could have denied it and support of senior leadership. said, ‘It happens,’ or we could ”Our senior leaders were very The briefing and time-out start fresh and fix it. We chose committed. If an organization is In the OR, the essential finding to fix it,” says Diane Skorupski, seeking to do this without strong was a lack of focus during the MS, RN, CNOR, NE-BC, admin- support from senior leadership, time-out and preoperative brief- istrative director of perioperative it won’t happen,” he says, noting ing. Changes were made to bring services. that RIH’s president and CEO, more focus: She and the medical director Timothy J. Babineau, MD, is also • The surgeon now leads the time- of perioperative services, Edward a surgeon. out. “That’s the only way to Marcaccio, MD, shared the lessons These are key findings and steps get everyone’s attention in the they have learned in an interview taken to make the surgical verifica- room,” Dr Marcaccio notes. with OR Manager conducted June tion process safer. • The time-out was streamlined 1, 2011. Skorupski has since left to three essential points: Verifi- the hospital. Preoperative process cation of the patient, of the site For the preoperative process, over- mark, and of the procedure. Identifying vulnerabilities whelmingly, the data showed the • To focus attention, all members Skorupski says RIH has taken a chief vulnerability was charts on of the team must point to and number of steps to identify its vul- the day of surgery not being com- touch the site mark. nerabilities: plete and in agreement. “That was “The pointing and touching • analyzed good catches as part of probably our largest concern,” help you to focus,” Dr Marcac- a state mandate for corrective ac- Skorupski says. cio observes. “We found in some tion In focus groups with the preop of our analysis that the surgeon • identified common threads from staff, “What came out loud and would say the right thing when root cause analyses of its own clear was that they felt rushed and he was verbalizing [the site], but incidents and in public reports busy.” his head would be somewhere from four states, California, Charts are now required to be else.” Massachusetts, Minnesota, and complete 24 hours prior to elective Pointing and touching occur Pennsylvania surgery or the case will be can- Continued on page 10

August 2011 OR Manager Vol 27, No 8 9 Patient safety

Large 3 ft x 5 ft posters are posted on the wall in each OR at Rhode Island Hospital to guide the surgical team in the time-out and briefing.

Continued from page 9 a checklist, it would become rote. even if the surgeon has chosen not “We want [the team] to commu- to mark the site. In this case, the “ nicate, critically assess the patient, surgeon says: “This is where I will The team and talk about what makes that make my incision. I have chosen patient unique.” not to mark. Does anyone have must touch A more recent development is any concerns?” the mark. the introduction of debriefings at • Visual cues also help bring the end of the case to review key focus. Large 3 ft x 5 ft posters in information, such as the procedure each OR guide the time-out and “ performed, wound class, and spec- briefing, a tip gained from the imens. CTH project (illustration). World Health Organization Surgi- “We are trialing different trig- cal Safety Checklist, including such gers,” Dr Marcaccio says. “We are Briefing lays the game plan items as patient allergies and ad- trying to see which elements of the Now that the time-out is hardwired, ministration of the antibiotic. debriefing work well.” the preop briefing has become im- The briefing, conducted when portant “in laying out the game the patient first enters the OR, is Changing the culture plan for everyone in the room,” Dr not a checklist, Skorupski empha- Senior leadership support was crit- Marcaccio says. The briefing fol- sizes. “It is a list of considerations ical in gaining the buy-in of every lows a format modified from the for discussion. We knew if we had one of the 1,200 perioperative em-

10 OR Manager Vol 27, No 8 August 2011 Patient safety Is postop nausea and vomiting ployees and physicians, Dr Mar- hereditary? caccio says. Education on surgical site veri- “ esearchers from Penn State fication is now mandatory for all Is your practice College of Medicine have staff and physicians and must be matching Rsingled out a genetic varia- documented as a competency in tion in patients who have post- each person’s personnel file. On- policy? operative nausea and vomiting going training is provided for new (PONV). physicians, residents, and staff. In the study, the researchers To kick off the effort, the ORs “ pooled DNA samples from 122 were closed for elective surgery patients with severe PONV. Find- for one day so the staff and physi- made to sentences or paragraphs ings identified 41 genetic targets cians could attend an educational as different situations arose. (called single nucleotide polymor- session together. Dr Babineau, the “Ask the staff, ‘Is your practice phisms, or SNPs) in these patients CEO, also attended. matching the policy?’ You will be that might have caused the predis- The education, held in 2009, in- surprised what you learn,” she position to PONV. Further analy- cluded both didactic material and suggests. Specialty teams may ses identified at least one SNP that practice on clinical scenarios for have different understandings of was common to the severe PONV physician-nurse teams led by about specific points. The policy may group. 50 trained clinician volunteers. be applied one way in pediatrics, “We hope identification of the For surgeons, active participa- in another by the heart team, and SNP will help better predict which tion in the surgical site verification in still another by the neuro team, patients are more susceptible to process is now a condition of being inconsistencies that can raise the PONV and enable anesthesiolo- able to operate at the hospital. risk of error. gists to take appropriate precau- Two elements were important Constant vigilance is needed tions before those patients receive to getting the surgeons on board, to ensure the policy is up to date, anesthesia,” said the lead author Dr Marcaccio says: internally consistent, thoroughly Piotr K. Janicki, MD, PhD. • Strong support from senior understood by the staff, and prac- Past studies have confirmed administration and physician ticed consistently. that female gender, use of volatile leadership. At RIH, as policy changes were anesthetics, previous history of • Four to five surgeons who were rolled out, the staff had questions PONV or morning sickness, and recruited to model the behavior. about specific points. Posting an- use of opioid drugs such as mor- “These are not necessarily the swers to frequently asked ques- phine or codeine during or after chiefs of departments but active tions where everyone could read surgery are contributing factors surgeons,” he notes. That has them helped to resolve many of to PONV. helped to influence the others. these issues. The authors say the study, He thinks his role as medical About the overall effort, she published in the July 2011 An- director for perioperative services says, “Before jumping into this esthesiology, will be useful in also made a difference. level of change, you have to ask, developing potential preopera- “It helps that any rule I signed ‘Is your organization ready?’” tive tests to determine patients’ off on, I have to comply with. It Senior leadership and surgeon PONV risk. ❖ helps the surgeons to feel we are leadership had to pull together —Janicki P K, Vealey R, Liu J, et all in this together.” to bring about the level of change al Anesthesiology. 2011;115:54-64. that was needed. ❖ Additional advice —Pat Patterson Skorupski offers additional ad- Have an idea? vice to perioperative leaders: Read your policy on surgical OR Manager welcomes your site verification from beginning ideas and contributions for arti- to end. Then meet with small cles. groups of staff to learn how that policy is actually being practiced. Contact Pat Patterson, editor, In reviewing the RIH policy, at [email protected]. she found 15 changes had been

August 2011 OR Manager Vol 27, No 8 11 OR communication

Continued from page 1 problem before you can do some- thing about it,” he says. “Too often, OR staff and physicians don’t really seem to care about the noise.” But they should care. “The ear is a wear and tear organ,” says Dr Fritsch. Although clinicians read- ily understand potential hearing damage from sources such as jet flight or a jackhammer, they fail to appreciate the dangers in their own ORs. In a 2010 study published in Otology & Neuro- tology, Dr Fritsch and colleagues reported that instrument noise The Responder5 Nurse Call communica- levels for average-length surgical tion system at Methodist West Hospital cases may exceed Occupational can be customized to contact staff by roles. Safety and Health Administra- tion (OSHA) and National Insti- “normalization of deviance.” For tute for Occupational and Health example, people start perform- (NIOSH) recommendations. Or- ing a deviant behavior, such as thopedics, neurosurgery, and playing music in the background otolaryngology are specialties at too high a volume. As a result, particularly at risk. Commonly equipment alarm volumes need to used instruments generated fre- be set higher. quencies as high as 131 dB, add- “Humans get used to talking ing to the typical baseline noise louder in order to be heard. Peo- level of 53 dB. ple don’t recognize that they are Higher frequency noise is the shouting at each other,” says Dr loudest and therefore the most Gibbs. “The deviant behavior be- damaging, but even occasional comes normal.” but recurrent loud sounds can add up to a serious problem. Changing the environment Potential harm isn’t limited to Many ORs are changing the en- the ears. A pilot study of 35 pa- vironment to reduce noise. Some tients published in the British Jour- hospitals have piped in calming nal of Surgery found higher noise music in the hallway that tends levels during elective abdominal recommends NIOSH standards to reduce conversation. But procedures were associated with because they are more protective; music in the individual OR poses an increased risk of surgical site maximum noise exposure limits a problem for Dr Gibbs, who infections during 30 days after are 8 hours at 85 dB. doesn’t allow music to be played surgery. Talking about nonsurgi- A 2010 review article in the while she is operating. She sees cal topics significantly increased Journal of PeriAnesthesia Nursing music “not as a distraction but noise levels. reported average noise levels in as a source of abrasion. Music is the OR between 51 and 75 dB, a way the dominant members of What’s acceptable? with maximum levels between 80 the hierarchy exert control over Although experts agree noise and 119 dB. The noisiest period the others.” causes harm, determining accept- was anesthesia induction, with She adds, “Why should the sur- able noise levels is challenging staff activities the biggest source geons be the ones to choose the because OSHA and NIOSH use of noise. music? The air is public space.” different metrics to determine Dr Gibbs says an additional If the surgeon likes country noise exposure limits. Dr Fritsch problem in managing noise is music, and the staff doesn’t, “it

12 OR Manager Vol 27, No 8 August 2011 OR communication

cal services. “We haven’t had an Tips for reducing overhead page in the OR for 18 OR noise “ months.” Music can The hospital, which focuses pri- “Sounds in the OR don’t act be an marily on orthopedics, assigns the as a distraction; it’s that it Responder Nurse 5 system’s wire- takes more to get someone’s abrasion. less phones to a role as opposed attention. We need to reset to an individual; for instance, the the ambient level of sound in x-ray technician assigned to the the OR,” says surgeon Verna “ OR carries a phone so he or she Gibbs, MD. Causes of noise can be easily reached. can be grouped into roughly we only use for transport; we call Each OR has an interface panel two categories: equipment it ‘5th Avenue,’” says Michelle consisting of touch-screen buttons and people behavior. Here Burke, MSA, RN, CNOR, asso- (illustrations, p 12). Depending are a few examples of how to ciate hospital administrator and on what button is selected, the reduce noise: director of nursing, perioperative system sends text messages to the • Wear earplugs or muffs services. appropriate phones. For instance, during critical times such as “All the OR rooms are set back the “Prep” button summons the drilling. Caution: It may be from that corridor. It reduces patient care technician. When it’s harder to hear alarms and hustle and bustle.” The design of room turnover time, the nurse voices. the main postanesthesia care unit pushes a button to send text mes- • Write noise reduction strat- (PACU) with pods of 3 to 4 beds sages to staff who assist with the egies into OR policies. For rather than a single open unit also turnover or need to know it’s oc- example, don’t allow music cuts down on noise. curring. during the time-out or Tools such as Vocera and the counts. Enlisting technology Responder 5 Nurse Call can be • Keep equipment in good re- Technology can create noise, but pricey, but not all environmental pair to avoid squeaking and it’s also being used to reduce it. solutions require a large invest- other noises. Memorial Sloan-Kettering OR ment. • Do construction at night. staff and anesthesiologists use • Change from metal to plas- the Vocera wireless communica- Tracking the yacking tic shelving in case carts tion system (www.vocera.com) to “The preop area is the biggest and storage areas. communicate and eliminate over- noise producer,” says Jane Wag- • Mute cell phones during head pages. ner, BSN, RN, CNOR, director of surgery or better yet, leave Aileen Killen, PhD, RN, direc- perioperative services for Shea them outside the OR. tor of patient safety at Memorial Medical Center in Scottsdale, Ari- • Use the technology of cell Sloan-Kettering and former direc- zona. “It’s where everyone con- phones, beepers, and other tor of the OR, says that technology gregates, including family mem- devices to reduce overhead integrated into the hospital’s sys- bers, surgeons, nurses, and anes- paging. tem also helps avoid distraction. thesiologists.” The area now has “When you accept a call from pa- a wall-mounted Yacker Tracker thology, for example, the system (http://yackertracker.com), which creates a hostile environment for automatically turns off the music lights up when a preset noise level everyone else in the room.” Music in the OR.” is reached. can be beneficial for patients, so Methodist West Hospital, West “We can set it to whatever sen- she suggests having them use Des Moines, Iowa, implemented sitivity we want,” says Wagner. headphones so they can listen the Responder 5 Nurse Call com- “When it lights up, you can just without disturbing others. munication system (www.raul- point to it, and you don’t have to and.com/responder5.cfm) in its say anything.” This low-cost so- Designing out noise surgical department. lution — the basic model is well ORs like Memorial Sloan-Ketter- “It has far exceeded our ex- under $100 — originated in the ing Cancer Center in New York pectations,” says Laurie Johnson, classroom where teachers use are using design to reduce noise. RN, executive director for the or- them to reduce chatter. Wagner “We have a main corridor that thopedic service line and surgi- Continued on page 14

August 2011 OR Manager Vol 27, No 8 13 OR communication

Continued from page 13 The steps for the Zone of Si- is now considering the Yacker lence: Tracker for the surgery control “ 1. The scrub nurse tells the cir- desk and PACU. A Zone of culating nurse when closure will Silence reduces begin. A beeper program 2. The circulating nurse an- Burke says Memorial Sloan-Ket- distraction. nounces to the team that closing tering is piloting a beeper pro- counts are about to start. gram. “We ask fellows and at- 3. The surgeon performs a tendings to leave their beepers at “ “sweep” and visual inspection of an assigned desk while they are the surgical wound, and then the in surgery.” A service coordinator ica (HCA), the organization’s count begins. manages the beepers and triages count policy includes, “Unnec- 4. The intraoperative team phone calls. The coordinator calls essary activity and distractions maintains and respects the “quiet the OR if the surgeon is needed (eg, multitasking, radio, equip- time” needed for the count. urgently. ment, pagers, conversations) will “The nursing staff appreciated “Chief residents and fellows be curtailed during the counting that we recognized their contribu- get most of the pages,” says process to allow the scrub per- tion and that doing a count is an Burke, “so the expectation is for son and RN circulator to focus on important thing,” says Dawson. them to hand off while they are in counting tasks.” surgery so there aren’t an exces- A healing environment sive number of pages.” Zone of Silence Wagner says OR noise reduction Attending surgeons who have Another strategy is to apply the is part of a general hospital effort a BlackBerry or smart phone “sterile cockpit” concept from to get back to the basics. “We’re can transfer their beeper calls to aviation: Nonessential activities trying to create a healing environ- a designated number as part of during critical phases of flight ment and one way to do that is to the program, which runs Monday such as takeoff and landing are reduce noise.” ❖ through Friday. Burke was able to prohibited. At Memorial Sloan- —Cynthia Saver, MS, RN make the additional position bud- Kettering, the surgical count time get neutral. All of the OR service is called the “red zone.” “When Cynthia Saver, a freelance writer, is coordinators have been educated the circulator nurse calls the red president, CLS Development, Inc, about the program. Although zone, no handoffs, no phone calls, Columbia, Maryland. they are not nurses or technicians, and no visitations are accepted,” Burke says their experience in the says Killen. References OR made it easy for them to tri- Tony Dawson, MSN, RN, vice AORN. AORN Position Statement age calls. Physicians have been president for operations at New on Noise in the Perioperative pleased with the program. York-Presbyterian Hospital, New Practice Setting. Approved March 2009. www.aorn.org/ York City, says the OR uses a PracticeResources/AORNPosi- Quiet: Counting in “Zone of Silence” to reduce dis- tionStatements/PositionState- progress traction from noise and other fac- mentOnNoise/ Some ORs have integrated noise tors, such as calling for an ICU Fritsch M H, Chacko C E, Patter- reduction into the Universal Pro- bed or for a room turnover. son E B. Operating room sound tocol for surgical site verifica- John Evanko, MD, vice presi- level hazards for patients and tion, calling for staff to reduce dent of perioperative services, physicians. Otol & Neurotol. noise during critical events such makes the case for the proce- 2010;31:715-721. as time-outs. Noise can cause dure: “Anesthesiologists need Hasfeldt D, Laerkner E, Birkelund significant distractions during quiet while they are putting R. Noise in the operating room— counting, so hospitals have tar- the patient to sleep, and when I What do we know? A review of geted that time frame in their clamp the aorta, I need to give the literature. J PeriAnesth Nurs. policies. According to Stephanie my full attention and not be dis- 2010;26 (6):380-386. Davis, MS, RN, CNOR, assistant tracted. It’s the same with nurses Kurmann A, Perter M, Tschan F, et vice president, surgical services and the count. It’s a critical part al. Adverse effect of noise in the for the clinical services group, of their role and we need to re- operating theatre on surgical-site Hospital Corporation of Amer- spect that.” infection. Br J Surg. 2011;98:1021-5.

14 OR Manager Vol 27, No 8 August 2011 Rapid methicillin-resistant Staphylococcus aureus (MRSA) screening in infection control programs u AuguSt 2011

Editor’s OR leaders are striving to make evidence-based decisions about new Note technology. OR Manager, Inc., and ECRI Institute have joined in a u collaboration to bring quarterly supplements with summaries of the Institute’s Emerging Technology Evidence Reports to OR Manager readers. ECRI Institute is an independent nonprofit organization that researches best approaches to improving patient care. It does its work by analyzing the research literature and data on clinical procedures, medical devices, and drug therapies. This summary provides a review of the literature through May 25, 2010.

technology description Infection control officers initiate MRSA screening to identify individuals who could develop a life-threatening infection or transmit the bacterium to those at high risk for serious infection (i.e., patients in intensive care units, orthopedic units, burn units, oncology units, or hemodialysis centers). Identifying MRSA carriers preoperatively in the outpatient setting or shortly after admission to a healthcare facility allows for preventive steps (e.g., contact isolation, nasal antibiotics, chlorhexidine showers, choice of the appropriate prophylactic systemic antibiotics) to decrease bacterial infection rates and lower overall costs to care for infected patients. Rapid screening for methicillin-resistant Staphylococcus aureus (MRSA) involves using a test method that has an expected turnaround time of less than 24 hours. To screen for MRSA, healthcare workers swab a designated area (i.e., anterior nares, throat) to obtain a test sample. The laboratory technologist tests the sample using molecular methods and/ or special chromogenic culture methods. Rapid MRSA screening using molecular diagnostics amplifies the targeted DNA molecule. To perform molecular testing, a laboratory technologist or healthcare professional uses a polymerase chain reaction (PCR) thermal cycling system to process the sample. Expected turnaround time for PCR tests ranges from one to four hours; however, real-world turnaround times vary depending on the methods, sample throughput volume by a laboratory, and availability of personnel to perform the test. Technologists can also use newer selective agar formulations to grow bacteria in the lab and identify MRSA based on a color reaction (i.e., chromogenic media). The expected turnaround time for this method is 24 hours; however, confirmatory testing may take up to 48 hours.

2011 supplement to or manager Vol 27, No 8, August 2011

MS11352.indd 2 7/6/2011 1:06:50 PM Regulatory status The Centers for Disease Control and Prevention and the Society for Healthcare Epidemiology of America offer a Between 2004 and 2010, the U.S. Food and Drug hospital epidemiology course each year. Administration (FDA) granted 510(k) marketing clearance for 10 tests/products used for rapid MRSA The Certification Board of Infection Control and screening. Epidemiology, Inc., certifies professionals in infection control and applied epidemiology. Indications/contraindications Some manufacturers provide training for healthcare According to product labeling, rapid MRSA tests are professionals in rapid MRSA testing. For example, “intended to aid in the prevention and control of MRSA Cepheid offers a 4-hour training program in seminar infections in healthcare settings. They are not intended format with a laboratory component at the customer to diagnose MRSA infections nor to guide or monitor site, and bioMerieux offers on-site training for customers treatment for MRSA infections.” wanting to use molecular tests. Impact on hospital operations Effect on other technologies To determine which screening test is appropriate, facilities Rapid MRSA tests that provide results in less than 24 need to consider the test performance, ease of use, cost, hours compete with conventional culture methods, which turnaround time, laboratory staffing, laboratory space and can take up to 72 hours to complete. certification, and training/ongoing support provided by In some cases, rapid screening tests complement the manufacturer. Although many hospitals own a thermal diagnostic tests for MRSA infection. When a screening PCR cycler, facilities should check product labeling to test is positive, providers often order a standard MRSA ensure PCR compatibility with particular rapid MRSA diagnostic culture or a diagnostic molecular test. assays. MRSA screening programs must determine in advance the normal and maximum potential numbers of samples that will need processing each day if they are Cost-effectiveness/considerations considering using PCR testing. The number of rapid Costs for rapid MRSA screening depend on screening PCR tests that a laboratory may perform concurrently is policies, test method, and test brand. limited to the capacity of the thermal PCR cycler systems, When considering only the materials cost of rapid the numbers of technicians trained on the procedure, testing, using a PCR method is more costly than using and the laboratory workflow. Some rapid PCR tests can chromogenic media ($29 to $42/test vs $2 to $8/test). be run “on demand,” while others that run in batches However, the cost of labor and additional supplies or may be processed less frequently in low-volume screening equipment may narrow this differential, particularly if programs. No special equipment is required to use confirmatory cultures and multiple control samples are chromogenic agar plates for MRSA screening. required. In addition, facilities must consider the higher cost of PCR testing in terms of the possible benefit of Safety faster results. Rare and minor risks associated with the nasal swabbing Rapid MRSA screening costs (i.e., expenses related to procedure (e.g., puncturing of the nasal mucosa, testing, additional infection control supplies and rooms, contaminating the nasal passage from nonsterile swabs) and additional staff time) may be offset if rapid screening can occur. results in a decrease in hospital-acquired MRSA infections Institutions must use test results with caution in guiding and associated mortality. decisions about infection control measures for patients. Testing can sometimes produce false-negative or false- Reimbursement/coding/payment positive results. In January 2007, the Centers for Medicare & Medicaid (CMS) issued a national coverage determination providing Credentialing/training coverage for molecular MRSA tests for diagnostic testing. The Association for Professionals in Infection Control However, CMS does not have a national coverage policy and Epidemiology and the Society for Healthcare for MRSA screening. Epidemiology of America provide education on hospital ECRI Institute searches of 11 representative commercial infection control. third-party payers that provide their coverage policies online did not identify any policies on MRSA screening. 2011 SupplEmEnt to oR managER Vol 27, No 8, August 2011

MS11352.indd 3 7/6/2011 1:07:04 PM The American Medical Association has assigned the In the studies, which were all conducted in the United following Current Procedural Terminology (CPT) codes Kingdom, most patients were cared for in open wards that describe MRSA screening: and multibed bays. The generalizability of the studies’ infection control programs to hospitals that use small  Presumptive culture of pathogenic organisms, patient rooms with one or two patients per room, such as screening only. those typical in the United States, is unclear. None of the  Presumptive culture of pathogenic organisms, included studies compared programs using rapid MRSA screening only with colony estimation from density tests to programs without screening. chart. Two of the studies reported that outcomes varied across  Infectious agent detection by nucleic acid (DNA settings, but there is no clear association between types of or RNA) for MRSA using the amplified probe care settings and rapid screening program success. technique. How does the incidence of MRSA wound and In the inpatient setting, payment for MRSA screening is bloodstream infections in infection control programs included in the diagnosis-related group (DRG) payment. using rapid MRSA tests compare to programs using conventional culture tests and programs with no In an outpatient setting, the CMS clinical lab schedule for screening? Does this outcome vary by inpatient setting? 2010 set the following payment limits: One study reported clinical wound infection rates of 0.6%  Presumptive culture of pathogenic organisms, with rapid testing and 0.7% with conventional testing. screening: $9.50. The same study reported a septicemia rate of 0.03% with  Presumptive culture of pathogenic organisms, rapid testing and 0.06% with conventional testing. There screening only with colony estimation from density was no statistically significant difference in these rates, chart: $12.34. but the events were rare. One study provided insufficient evidence to form a conclusion.  Infectious agent detection by nucleic acid for MRSA using the amplified probe technique: $50.27. No studies compared programs using rapid MRSA tests to programs without screening. Evidence base No evidence was available to determine whether outcomes Three cluster, crossover studies met our study inclusion vary by inpatient setting. criteria for at least one of the key questions for this report What is the time until test notification of rapid MRSA and were included in our analysis: Aldeyab et al., 2009, tests? How does the time until notification compare to Hardy et al., 2009, and Jeyaratnam et al., 2008. conventional culture tests? Key clinical questions/findings Time to notification after rapid testing generally took 19 to 22 hours, which was consistently statistically How does the acquisition rate of MRSA in infection significantly shorter than conventional testing, which took prevention programs using rapid MRSA tests compare about twice as long in two studies and more than three to programs using conventional culture tests and times as long in the third study. programs with no screening? Does this outcome vary by inpatient setting? The available evidence suggests that infection control programs using rapid MRSA tests are as effective as Excerpted with permission from ECRI Institute’s database of programs that use conventional tests in preventing Emerging Technology Evidence Reports. The complete report can be acquisition. None of the studies identified a statistically purchased from ECRI Institute’s Health Technology Assessment significant difference between groups in univariate Information Service at [email protected]. analysis. While data from additional studies will increase ECRI Institute is an independent nonprofit health services research the power of the evidence base, which could lead to the agency designated as an Evidence-based Practice Center by the US detection of a statistically significant difference overall, Agency for Healthcare Research and Quality. The Institute maintains it seems unlikely that the difference will be clinically the strictest conflict-of-interest standards in the health care industry to significant, assuming the size of the difference in future protect against biases and ensure the integrity of its information. studies is similar to the size of the difference reported by studies in the current evidence base. Vol 27, No 8, August 2011 2011 supplEmEnt to or managEr

MS11352.indd 4 7/6/2011 1:07:15 PM State of Evidence Base SELECTED RESOURCES  Mod Mod Aldeyab M A, Kearney M P, Hughes C M, et al. Can the use of a rapid polymerase chain screening Low High Low High method decrease the incidence of nosocomial methicillin-resistant Staphylococcus aureus? J Hosp Infect 2009 Jan;71(1):22-8.  Hardy K, Price C, Szczepura A, et al. Reduction ECRI ECRI in the rate of methicillin-resistant Staphylococcus QUANTITY QUALITY aureus acquisition in surgical wards by rapid screening for colonization: a prospective, cross-over Mod study. Clin Microbiol Infect 2010 Apr;16(4):333-9.  Low High Jeyaratnam D, Whitty C J, Phillips K, et al. Impact of rapid screening tests on acquisition of methicillin resistant Staphylococcus aureus: cluster randomised crossover trial. BMJ 2008 Apr ECRI 26;336(7650):927-30. CONSISTENCY © ECRI Institute 2011

Quantity of Evidence Base (Low) ree cluster, crossover studies with 20,194 patients were included, but one was quite small. Considering the low rates of methicillin- resistant Staphylococcus aureus acquisition, and only one study reported on reduction in wound and bloodstream infections, we rate quantity as low. Quality of Evidence Base (Moderate) ese studies were generally well designed, but potential sources of bias in one or more study included lack of allocation concealment, excessive (>15%) data loss, and potential con ict of  nancial interest. Consistency of Evidence Base (High) e three studies consistently found that the unadjusted overall di erence in methicillin-resistant Staphylococcus aureus acquisition rate between programs using rapid tests and those using conventional tests was less than clinically signi cant (<33%). It was statistically signi cant in one of the three studies when adjusted in multivariate analysis. Time to noti cation was consistently shorter by about 24 hours when rapid tests were used.

SUPPLEMENT TO OR MANAGER ECRI Institute VOL 27, NO 8, AUGUST 2011 5200 Butler Pike www.ormanager.com Plymouth Meeting, PA 19462-1298, USA Tel +1 (610) 825-6000 Fax +1 (610) 834-1275 Web www.ecri.org

Vol 27, No 8, August 2011 2011 SUPPLEMENT TO OR MANAGER MS11352

MS11352.indd 1 7/6/2011 1:06:35 PM State of Evidence Base SELECTED RESOURCES Infection control  Mod Mod Aldeyab M A, Kearney M P, Hughes C M, et al. Can the use of a rapid polymerase chain screening Low High Low High method decrease the incidence of nosocomial Quandary: What to do for vaginal prep methicillin-resistant Staphylococcus aureus? J Hosp Infect 2009 Jan;71(1):22-8. t’s a question ORs have faced  Hardy K, Price C, Szczepura A, et al. Reduction for several years—what do Status of ECRI ECRI in the rate of methicillin-resistant Staphylococcus you use for the vaginal prep QUANTITY QUALITY I “ Techni-Care aureus acquisition in surgical wards by rapid when the patient is allergic to The evidence screening for colonization: a prospective, cross-over povidone iodine? The maker of Techni-Care Mod study. Clin Microbiol Infect 2010 Apr;16(4):333-9. After Techni-Care (PCMX, or is not (PCMX), taken off the market  chloroxylenol) stopped being Low High Jeyaratnam D, Whitty C J, Phillips K, et al. plentiful. in 2009, may soon resume sales Impact of rapid screening tests on acquisition made in 2009, clinicians were left of a skin antiseptic with a claim of methicillin resistant Staphylococcus aureus: without a skin prep indicated for for the surgical skin prep. cluster randomised crossover trial. BMJ 2008 Apr use in the genital area for iodine- A representative of the ECRI 26;336(7650):927-30. allergic patients. “ manufacturer, Care-Tech Labo- CONSISTENCY “There really is no good black study, published in 2010 in the ratories, St Louis, said in June © ECRI Institute 2011 and white answer,” says Peggy New England Journal of Medicine, that it has nearly completed the SaBell, MS, RN, CIC, a member found a chlorhexidine-alcohol process of bringing its docu- of the communications committee product compared with povi- mentation system into con- Quantity of Evidence Base (Low) for the Association for Profession- done-iodine scrub and paint re- formance with the Food and ree cluster, crossover studies with 20,194 patients were included, als in Infection Control and Epi- sulted in a 41% lower surgical site Drug Administration’s (FDA) but one was quite small. Considering the low rates of methicillin- demiology (APIC) and regional infection rate. requirements. The company resistant Staphylococcus aureus acquisition, and only one study infection prevention and control In the only randomized con- suspended manufacture of its reported on reduction in wound and bloodstream infections, we director for Kaiser Permanente’s trolled trial comparing 4% aque- products in 2009 over regula- rate quantity as low. Colorado region. ous CHG with povidone iodine as tory issues. Nurses find themselves in a a vaginal prep, by Patrick J. Culli- Once that process is com- Quality of Evidence Base (Moderate) Catch 22: The skin prep is a main- gan, MD, FACOG, FACS, and col- plete and audited by the FDA, stay in the prevention of surgical leagues, 50 vaginal hysterectomy the company expects to market ese studies were generally well designed, but potential sources of site infection, yet none of the al- patients were randomized to have Techni-Care again, according bias in one or more study included lack of allocation concealment, ternatives currently on the market preoperative preps with 10% pov- to Care-Tech customer service excessive (>15%) data loss, and potential con ict of  nancial carries the appropriate label claim idone iodine or 4% aqueous CHG. representative, Kim Miller. interest. and manufacturers’ instructions CHG was found to be more effec- She said Techni-Care would for the vaginal prep. Professional tive in decreasing bacterial colony be labeled “nontoxic” and Consistency of Evidence Base (High) guidelines and regulations em- counts. would carry no contraindica- e three studies consistently found that the unadjusted phasize the importance of follow- “My study and others clearly tions for its use on parts of overall di erence in methicillin-resistant Staphylococcus aureus ing manufacturers’ instructions. show that it is safe and effective to the body. Once the product is acquisition rate between programs using rapid tests and those What are OR leaders to do? Sa- use 4% aqueous CHG as a vaginal released, she said it would take using conventional tests was less than clinically signi cant Bell’s advice: Gather a multidis- prep,” Dr Culligan told OR Man- about 90 days to catch up with (<33%). It was statistically signi cant in one of the three studies ciplinary team, examine the evi- ager. He is director of urogynecol- a large volume of back orders. when adjusted in multivariate analysis. Time to noti cation was dence, and make a decision that is ogy at the Atlantic Health System At the time manufacture consistently shorter by about 24 hours when rapid tests were used. best for your organization. in New Jersey and professor of ceased in 2009, Care-Tech The evidence is not plentiful. obstetrics and gynecology at the stated that neither the FDA nor Three alternative prep solutions Mount Sinai School of Medicine the company was aware of re- have been the subject of small in New York City. ports of injury or illness related studies. Though Dr Culligan says he to the products, and the FDA thinks 4% aqueous CHG could did not require a recall. Chlorhexidine gluconate be safely used as a vaginal prep, SUPPLEMENT TO OR MANAGER ECRI Institute The antiseptic 4% chlorhexidine he does not routinely use it in his gluconate (CHG), widely used as own practice because a prep kit is lution. The method was described VOL 27, NO 8, AUGUST 2011 5200 Butler Pike Plymouth Meeting, PA a skin prep for other indications, not available. in a response to a letter in the www.ormanager.com American Journal of Obstetrics and 19462-1298, USA carries a warning label saying it In the study, the application Gynecology. Tel +1 (610) 825-6000 should not be used in the genital method for CHG was similar to Fax +1 (610) 834-1275 area, meninges, or head and face. that for povidone iodine: a 2-min- What type of tissue? Web www.ecri.org There’s strong evidence for ute vigorous scrub followed by a CHG as a surgical skin prep for “paint” application; for CHG, the Dr Culligan says much of the di- other areas of the body. One large scrub and paint used the same so- Continued on page 20

Vol 27, No 8, August 2011 2011 SUPPLEMENT TO OR MANAGER MS11352 August 2011 OR Manager Vol 27, No 8 19

MS11352.indd 1 7/6/2011 1:06:35 PM Infection control

Continued from page 19 lemma about use of CHG in the FDA regulatory framework for skin antiseptics vagina springs from incorrect use Skin antiseptics are regulated under the FDA’s Tentative Final Monograph of the term “mucosal” to refer to (TFM), issued in 1994. the lining of the vagina, which in fact is epithelial tissue. Common TFM category Description use of the term “vaginal mucosa” doesn’t mean the vagina is a mu- Category I Antimicrobial products generally recognized as safe and cosal surface, he says. effective. An additional description is Examples: Isopropyl alcohol 70%-91.3%, povidone provided by Danny J. Schust, MD, iodine 5%-10% a researcher at the University of Missouri School of Medicine, Co- Category II Antimicrobial products not generally recognized as safe lumbia. and effective. Unlike skin, he says, vaginal Example: Hexachlorophene tissue is not keratinized, “and keratinization offers a lot of pro- Category III Available data are insufficient to classify as safe and tections.” He adds, “The ectocer- effective. vix is a transition zone toward the single epithelial cell layer of Examples: PCMX, triclosan, benzethonium chloride the endocervix, and both of these NDA (new drug If the proposed product has ingredients of concentrations would be exposed to vaginal ap- application) not recognized as safe and effective in the TFM, it must plication of CHG.” undergo rigorous testing for safety and efficacy. Gray’s Anatomy, 40th edition, describes the vagina as “a fibro- Example: Chlorhexidine gluconate muscular tube lined by nonkera- tinized stratified epithelium.” The Source: Food and Drug Administration. Tentative Final Monograph for Health-Care description continues, “There are Drug Products (21 CFR Parts 333, 369). 1994. no mucous glands, but a fluid transudate from the lamina pro- OR Manager acknowledges Travis Becker of CareFusion for assistance with this pria and mucus from the cervical chart. glands lubricate the vagina.”

Adverse reactions to CHG? in the recovery room after uro- adverse reactions were reported. Are adverse reactions a concern logical surgery with reactions at- Solutions used were 0.2% CHG with 4% CHG in the vaginal area? tributed to use of a CHG-contain- and 0.25% CHG. A third series, “I have never seen an ad- ing lubricant gel. In a 2008 report involving 600 women in Africa verse reaction,” Dr Culligan says. from Korea, a patient had an ana- who received vaginal lavage with “There are a few case reports de- phylactic reaction during a digital CHG or no treatment during scribing adverse reactions, but by rectal exam with chlorhexidine labor, reported comparable low definition, case reports describe jelly. He later tested positive for rates of itching, stinging, or other rare events. There are also case re- a chlorhexidine allergy. In a 2007 complaints for both groups. ports describing adverse reactions report from the Netherlands, 3 to iodine.” men developed anaphylactic reac- Baby shampoo Among the case reports is one tions attributed to a gel used dur- Some opt to use baby shampoo, from 2004 in which a healthy pre- ing urinary catheterization. based on a small study by Linda menopausal woman developed On the other hand, Dr Culli- A. Lewis, MD, and colleagues desquamating vaginal tissue from gan’s article refers to large series from Stanford University. The a CHG prep. There are also a few where there were no adverse reac- study compared postop infection reports of serious allergic reac- tions to CHG used in the vaginal rates for patients having vagi- tions to CHG used in the genital area for preventing infections in nal preps with either povidone area, including anaphylaxis. A mothers and infants during child- iodine or baby shampoo before 2009 case report from the UK de- birth. In series involving 1,024 minimally invasive gynecologic scribes 3 patients who collapsed patients and 6,964 patients, no surgery. The baby shampoo was

20 OR Manager Vol 27, No 8 August 2011 Infection control

diluted 1:1 in normal saline. Charts were reviewed for 249 About off-label use patients after surgery, 96 before Those with questions about off- • ”The practitioner who pre- the switch to baby shampoo and label use might find a statement scribes a drug is responsible 153 after. Infection rates were from the American Academy of for deciding which drug and 14.6% for povidone iodine and Pediatrics helpful. The statement dosing regimen the patient 11.8% with baby shampoo. was issued because in the care will receive and for what pur- Experts note that this is a small of children, products often come poses.” study, and baby shampoos differ with the disclaimer, “safety and • ”The off-label use of a drug in their formulations. efficacy in pediatric patients should be based on sound have not been established.” scientific evidence, expert Saline for prep medical judgment, or pub- In a small study from 1981 in- Summary of key points lished literature. New uses, volving 17 patients having vagi- • ”Off-label use does not imply doses, or indications will not nal hysterectomy who received an improper use and certainly be approved by the FDA until prophylactic antibiotics, no dif- does not imply an illegal use substantial evidence of safety ference was found in outcomes or a contraindication based on and effectiveness for that indi- for patients prepped with normal evidence.” That’s distinct from cation or age group is submit- saline or povidone iodine. The explicit warnings or contrain- ted to the FDA. This may take authors said they thought the di- dications against uses, which years or may never occur.” lution effect of saline or antisep- are important medically and • Off-label use should be con- tic might be a factor in reducing legally. ducted in good faith and infection. • ”The FDA regulates the without fraudulent intent. manufacture, labeling, and Guiding clinicians promotion of drugs; it does Reference After examining the evidence, not regulate the use of drugs American Academy of Pediatrics. San Diego-based Sharp Health- by physicians (ie, the practice Uses of drugs not described in care has given its physicians in- of medicine).” the package insert (off-label uses). Pediatrics. 2002;110:181-183. formation on use of 4% aque- ous CHG as a preoperative vaginal prep for iodine-allergic plaining the risks and benefits, concentration, testing, and label- patients, particularly for proce- that the product can be used off ing criteria. Companies are re- dures at higher risk of SSI such label, and that the risk of an ad- quired to follow the testing crite- as robotic-assisted vaginal hys- verse outcome is low. ria under the document, but the terectomy or procedures with Those with questions about off- FDA does not review the data. implants. A forum of Sharp’s label use may find a statement These products are termed “com- infectious disease physicians from the American Academy of pliant” but cannot claim FDA and infection preventionists Pediatrics helpful (sidebar). approval. The TFM classifies ac- advised surgeons to weigh the tive ingredients in skin antisep- risk of a surgical site infection The regulatory backdrop tics into Categories I, II, and III with the risk of an adverse reac- Much of the quandary over (chart, p 20). tion, which seems to be small. skin antiseptics stems from the Products that don’t fall under For non-high-risk surgery with- Food and Drug Administration’s the TFM must go through a sepa- out implants, an option is half- (FDA) confusing regulatory rate, more rigorous process called strength baby shampoo. framework. Skin antiseptics fall a “new drug application” (NDA). “Our women’s hospital has under a 1994 document called For NDA products, the FDA used Hibiclens (CHG) for some the Tentative Final Monograph does examine the testing data and time without incident,” says (TFM) for Healthcare Drug Prod- approve the product prior to mar- Shannon Oriola, RN, CIC, COHN, ucts (21 CFR Parts 333, 369). keting. lead infection preventionist for Though never finalized, the TFM CHG is considered an NDA the Sharp Metropolitan Medical governs the way antiseptics can product, meaning it must un- Campus. be marketed. It sets forth efficacy dergo rigorous testing and be ap- Infection preventionists are criteria and defines requirements proved by the FDA for additional distributing a memo to nurses ex- for active ingredients, including Continued on page 23

August 2011 OR Manager Vol 27, No 8 21 GI endoscopy What’s new in endoscopy guidelines? lexible endoscope reprocess- because data is lacking. Reuse ing continues to be a major within 10 to 14 days of high-level Ffocus in infection preven- “ disinfection without reprocess- tion. All of the known cases of How long can ing appears safe, the Multisociety pathogen transmission during GI Guideline notes. AORN, in con- endoscopy have been traced to an endoscope trast, recommends that flexible breaches in accepted cleaning and be stored? endoscopes be reprocessed be- disinfection guidelines or other fore use if unused for more than infection prevention practices. 5 days. A revised Multisociety Guide- “ Why the difference? line on Reprocessing Flexible GI “Really, the existing data don’t Endoscopes, released in June 2011, such as flushing catheters is re- define a specific timeframe after updates recommendations from viewed. which it becomes unsafe to reuse the previous 2003 edition. Among • A recommendation is added to endoscopes,” Dr Petersen told changes are more detail on repro- follow standard aseptic prac- OR Manager. “Some data clearly cessing of attachments and on in- tices when administering medi- suggest safety to 5 days, without jection safety during endoscopy, cations during endoscopy pro- demonstrating any risk thereafter. both of which have been tied to cedures. Some data clearly suggest safety widely publicized infection con- Faulty use and reprocessing of beyond 5 days. But there is no trol lapses in the past few years. auxiliary tubing in some GI clin- defined endpoint to the safe shelf The guideline also airs unre- ics, including several in the De- life or hang time in the data that solved issues such as “hang time”; partment of Veterans Affairs, re- have been published.” that is, how long a flexible GI en- ported in 2008 led to widespread The 10- to 14-day recommenda- doscope should be stored before patient notifications and screening tion was adopted as a “reasonable needing to be reprocessed be- for hepatitis and HIV. A number compromise,” he says. fore use on the next patient, and of cases were identified, though whether to test scopes for quality whether they are related to the Microbiological testing assurance purposes. reprocessing errors is undeter- Routine microbiological testing Eleven organizations partici- mined. of endoscopes for quality assur- pated in the update, led by the Unsafe injection practices led ance “has not been established American Society for Gastrointes- to the notorious outbreak of hepa- but warrants further study,” the tinal Endoscopy (ASGE) and the titis in 2007 in patients treated at guideline states. Society for Healthcare Epidemi- an endoscopy center in Nevada, The challenges are a lack of ology of America. Others include attributed to reuse of syringes and standardization in how to perform the major GI societies, AORN, use of single-use vials on multiple the testing and interpret the re- the Association for Professionals patients. Other such outbreaks sults. Also, the contaminants iso- in Infection Control and Epide- have also been reported. lated from testing are frequently miology, the Joint Commission, The guideline’s senior author, environmental. and the Society of Gastroenter- Bret T. Petersen, MD, FASGE, “Most of these isolates are non- ology Nurses and Associates. commented on some of the un- pathogenic and don’t represent Participating for the first time resolved issues that raise ques- person-to-person transmission,” was the Accreditation Associa- tions for GI labs. He is chair of he says. tion for Ambulatory Health Care the ASGE quality committee and Some international guidelines (AAAHC), representing outpa- professor of medicine and gas- do advise microbiological surveil- tient centers. troenterology at the Mayo Clinic, lance, such as those from Europe Rochester, Minnesota. and Australia. Key updates Says Dr Petersen, “It is a topic In highlights of changes: Endoscope ‘hang time’ that is extremely important be- • More details are provided for How long a flexible GI scope can cause we do need practical vali- critical reprocessing steps, in- be stored before it should be re- dated means to track the outcome cluding cleaning and drying. processed before use on the next of reprocessing in the clinical set- • Reprocessing for attachments patient is considered unresolved ting, not just during R and D,”

22 OR Manager Vol 27, No 8 August 2011 GI endoscopy Simple cotton swab lowers postop SSIs referring to research and develop- many uses over several days to ently probing a wound ment. But for now, he says, the a week before the concentrations with a dry cotton swab culture techniques are not stan- are insufficient. Gafter surgery for a perfo- dardized, and the results are hard The guideline provides flexibil- rated appendix dramatically re- to interpret. For that reason, “it is ity for sites to base their practices duced infections in a study. hard to provide firm guidance.” on their own data regarding dilu- Only 3% of patients who had tion, Dr Petersen notes. the daily probing got surgical site Checking disinfectant infections (SSIs) compared with concentration Broad consensus 19% in the control group who did The guideline recommends test- Though a number of organiza- not. ing the high-level disinfectant for tions have issued endoscope re- Though the exact mechanism the minimum effective concentra- processing guidelines, in nearly isn’t known, the researchers sur- tion (MEC) at the beginning of all respects, they are the same, Dr mise it may be because the probing each use day (or more frequently). Petersen says. allows contaminated fluid trapped Manufacturers of test strips may Regarding the Multisociety in soft tissues to drain. recommend more frequent testing. Guidelines, he says, “I think the The painless probing with the The guideline wording was left broad consensus that came out swab also resulted in less post- open so GI units would have lee- of the process we used and the operative pain and shorter hospi- way, Dr Petersen says. number of participating organiza- tal stays (five versus seven days). After discussions with rep- tions make it reasonable to adopt Patients also had better cosmetic resentatives of the GI societies, at least the consensus parts of this healing of their incisions. he says, there is a sense that the guideline as definitive.” The parts Half of the 76 patients in the manufacturers’ instructions to that are not definitive are because prospective, randomized trial had check the MEC before each repro- of a lack of objective data. their incisions loosely closed with cessing cycle may stem from “an With the participation of the staples, then swabbed daily with abundance of caution” and are Joint Commission and AAAHC, iodine (control group). The study “potentially self-serving for the it is also likely that the major ac- group had their incisions loosely manufacturers. It doesn’t appear crediting bodies will regard this closed. Their wounds were probed to be based on data reflecting how guideline as definitive, though he gently each day between the the dilution of the disinfectant oc- says whether they will adopt all staples with a dry, sterile cotton- curs,” he says. or part of the guideline for survey tipped applicator. ❖ The little independent data purposes is hard to predict. ❖ —Towfigh S, Clarke T, Yacoub W, available suggests it may take —Pat Patterson et al. Arch Surg. 2011;146:448-452.

Vaginal prep References povidone-iodine for surgical-site Amstey M S, Jones A P. Preparation of antisepsis. N Engl J Med. Jan 7, Continued from page 21 the vagina for surgery: Comparison 2010;362:18-26. label claims. CHG is not included of povidone-iodine and saline solu- Lewis L A, Lathi R, Crochet P, et al. in the TFM because when the FDA tion. JAMA. 1981;245:839-841. Preoperative vaginal preparation with baby shampoo compared with went through this regulatory pro- Bae Y J, Park C S, Lee J K, et al. Case of povidone-iodine before gyneco- cess starting in the late 1970s, the anaphylaxis to chlorhexidine dur- logic procedures. J Minim Invasive ing digital rectal examination. agency said it did not have enough Gynecol. 2007;736-739, data to include it. J Korean Med Sci. 2008;23:526-528. Parkes A W, Harper N, Herwadkar A. How CHG acquired the warn- Anaphylaxis to the chlorhexidine Am J Obstet Gyne- ing not to use it in the genital area Culligan P J. Letter. component of Instillagel: A case se- col seems to be lost to history. Compa- . 2006;195:625. ries. Br J Anaesth. 2009;102:65-68. nies say pursuing a change in the Culligan P J, Kubik K, Murphy M, Standring S, ed. Gray’s Anatomy. 40th label claim is difficult because the et al. Randomized trial that com- edition. London: Churchill Living- FDA has not established testing pared povidone iodine and chlor- stone/Elsevier, 2008. criteria for skin antiseptics to be hexidine as antiseptics for vaginal Van Zuuren E J, Boer F, Lai a Fat E used on vaginal tissue and because hysterectomy. Am J Obstet Gynecol. J, et al. Anaphylactic reactions to 2005:192:422-425. of the expense of such studies. chlorhexidine during urinary cath- —Pat Patterson Darouiche R O, Wall M J, Itani K M F, eterisation]. Ned Tijdschr Geneeskd. et al. Chlorhexidine-alcohol versus 2007;151:2531-2534.

August 2011 OR Manager Vol 27, No 8 23 Patient safety A new perspective on OR time-out ometimes it’s all in a word. Building confidence Struggling for compli- Hubrich and her management Sance with the pause before “ team have worked with the staff surgery, a Michigan hospital We’re seeing to help develop the skills of tried changing the terminology, some who were reticent to speak and that has made all the differ- a cultural up. ence. change. “We use anecdotes and stories. Instead of “time-out,” the new It might be that the least impor- term is “pa- tant person in the room knows tient safety something that is important to briefing.” “ that surgery,” she says. Once the old grandson when you put him An example is a case in which change was in the corner.” It was seen as an a staff member noticed that a sec- made, “we exercise in checking off boxes to ond piece of needed equipment saw imme- meet a regulatory requirement. wasn’t available. She spoke up, diately that ”We decided to take the focus which led to a discussion about t h e f o c u s off that word and really think whether to move forward with changed,” says the director of sur- about the patient and patient the surgery or wait for the equip- gical services, Sharon Hubrich, safety,” Hubrich says. ment to arrive. MSN, RN. “It went to a focus on The briefings are intended to the patient and the safety of ev- Ringing the bell improve safety not only for pa- eryone in the room.” A second breakthrough came tients but also for staff. A fire The idea came from a work when an anesthesiologist volun- safety assessment was recently group formed to talk about hur- teered “to ring the bell” to signal added. Staff also cover any safety dles to performing an effective the start of the briefing. He agreed issues related to equipment, such briefing, which had lagged for the to bring other anesthesia provid- as the use of powered equipment six-room OR. ers on board. and placement of the cord. “Things weren’t going that “To have anesthesia take the Patient safety debriefings have well. People were not taking it lead has really been important been added at the end of the case. seriously,” says, Hubrich, who is to us. It has helped pull the sur- Like many organizations, POH with POH Regional Medical Cen- geons in,” says Lawrence Abram- is discussing the timing and sur- ter in Pontiac, Michigan. POH is son, DO, the hospital’s director geon’s involvement in the debrief- participating in Michigan’s Key- of quality. Anesthesia provid- ing. Because of POH’s large surgi- stone Surgery project, a collab- ers use different triggers. Some cal residency program, attending orative to improve perioperative say simply, “We need it quiet surgeons often leave the OR while patient safety led by the Michigan now. We need to do our brief- a senior resident finishes closing Health and Hospital Association ing.” Others give a soft whistle the incision. and Johns Hopkins. or a “hush.” “We decided the attending sur- The work group’s participants Music is turned off. No one geon could begin the debriefing included anesthesiologists, sur- rattles instruments or moves by announcing he is leaving,” Hu- geons, residents, nurses, and equipment during the briefing, brich says. Before leaving, the sur- surgical technologists. In the which the surgeon leads. If the geon is to cover three points: discussions, a couple of issues surgeon hesitates, someone else • Did we do the procedure as emerged. jumps in. scheduled? “The first hurdle was that ev- “Everyone stops and turns to • Was there anything that did not eryone was so busy getting ready look at the patient,” says Hubrich. go well that should be reported for surgery that no one wanted to A poster in each OR has bullet out for quality improvement stop,” Hubrich says. points to guide the briefing and purposes? Another was the way the time- keep the process moving. • What went well, and is there out and briefing were perceived. “The poster is ever-changing as anyone we should commend? Said one person, “Time-out is we improve our wording or make After the surgeon leaves, the what you say to your four-year- additions,” she notes. rest of the team completes the de-

24 OR Manager Vol 27, No 8 August 2011 Managing Today’s OR Suite A call to self-care, reflection, and renewal hen was the last simple process for identifying life’s “ time you relived a purpose and integrating it into a Wfavorite bedtime stress-free environment. routine from your past? Do you Her closing session on Fri- remember the special feeling and day, Live Your Life, Dream Your aroma of a warm bath, clean paja- Dreams, is an invitation to self- mas, and freshly laundered sheets care, reflection, and renewal. with a relaxing bedtime story and Health and wellness have been a cup of warm milk or bedtime Weinstein’s focus since she ob- tea?” served that many of her fellow This is one tip from B is for Bal- nurses, while caring for their pa- ance, Sharon Weinstein’s book on tients, weren’t taking care of them- bringing life into perspective. selves. Weinstein speaks from experi- Her current passion is build- ence and her own quest for bal- ing an evidence base for nursing’s ance. Her nursing career spans in- wellness practice through a non- fusion therapy, home care, medical Closing speaker, Sharon Weinstein, profit she founded, the Integrative school, nursing faculty, and inter- MS, RN, CRNI, FACW, FAAN, will Health Forum (www.ihfglobal. national service. also present a breakout on achieving life com). She and her family have owned balance. Weinstein confesses to a quick 14 homes in 6 states, and she lived sense of humor, believing laughter in Moscow, where she served as aging Today’s OR Suite conference is a big enhancer of wellness. clinical advisor to the Kremlin September 28-30 in Chicago. She also believes learning Hospital. Her breakout on Friday, Sep- should be fun. “We focus on learn- Weinstein will share her mes- tember 30, The Wages of Stress: ing as fun-damental, and we put sages on health, wellness, and life The Importance of Life Balance, edu-tainment in education,” she goals in two sessions at the Man- will take the audience through a says. ❖

briefing. The process is continu- the other orthopedic surgeons ings, which Hubrich says had ing to evolve, she notes. and staff alike. They realized that been “dismal,” rose to 100%, if such an incident could happen where they have stayed for Stories of saves to that highly respected surgeon, weeks. Two recent error captures have it could happen to any of them, Comments Dr Abramson, dramatized the importance of Hubrich notes. “We’re seeing a cultural change.” briefings and offered teaching Since then, there has been dis- What made the difference, he moments for the staff and physi- cussion about whether to start thinks, is that the rationale for cians. the briefing earlier in the process, the briefings became internal- In one instance, a prolific or- perhaps in the hallway before the ized when physicians and staff thopedic surgeon, who performs patient enters the OR. “understood it was about patient multiple hip and knee replace- In another case planned for care, not about reporting some- ments in a day, changed the an obese patient, the team real- thing externally.” order of two patients. But not ev- ized during the briefing in the OR The briefing then became a eryone got the message. that the patient had an infection conversation about safety. As the team was starting the under a skin fold that hadn’t been “To have a conversation, you briefing, they immediately real- caught earlier. The patient hadn’t have to feel you are in a safe ized they were talking about a been anesthetized, and the case and supported environment,” different patient, Hubrich says. was cancelled. he adds. “For me, this is dem- Following the momentary confu- onstrating how to build a safe sion, the correct surgery was per- Compliance climbs environment for that kind of cul- formed. After the changes were intro- ture.” ❖ That story got the attention of duced, compliance with the brief- —Pat Patterson

August 2011 OR Manager Vol 27, No 8 25 What are your ASC’s security gaps? aptops are stolen from a phy- New security requirements are sician’s office in a break-in, part of the 2009 Health Informa- Lcompromising data for hun- tion Technology for Economic and dreds of patients. An employee “ Clinical Health (HITECH) Act. loses a personal hard drive that Assess ASCs may find helpful a se- contains patient data. A radiolo- your curity guide for small practices gist joins a new outpatient facility from the Department of Health and contacts patients from his pre- vulnerabilities. and Human Services. The guide vious employer, using information has questions to ask when assess- he downloaded before he left. ing security risks. Is your ambulatory surgery “ center (ASC) safe from data the Verizon report, the number Take the first step breaches like these? You may be went up to 761 from 141 the pre- The best first step is to conduct more vulnerable than you think. vious year. a risk assessment of your ASC’s Nearly half (49%) of all breaches data vulnerabilities and identify for businesses were by insiders, Security basics the gaps. Then develop a plan and 11% were by business part- Security basics can prevent most to plug the gaps and have a plan ners, according to a 2010 report breaches, Verizon experts say. for action if a breach occurs, ad- by Verizon Business in collabo- Only 4% require difficult and ex- vises Shawn Wotowey, CLCS, of ration with the Secret Service. pensive protections. the PFS Insurance Group, John- Almost half (48%) were attrib- Being prepared is the best stown, Colorado, who spoke at uted to users who accessed cor- defense. Too often—60% of the the Colorado Ambulatory Sur- porate information for malicious time—the breach is discovered by gery Association meeting in purposes. an outside party—a patient dis- April in Denver. There are also external threats. covers an unauthorized charge, Data security has four goals ASCs may think they’re beneath for example—and only after quite in line with the federal Security the radar for hackers, but hack- a bit of time has passed. Rule, part of the Health Insurance ers do target small organizations, With the push for electronic Portability and Accountability Act thinking they are more vulnerable health records (EHRs) come new (HIPAA): than larger ones. security concerns as physicians’ 1. Ensure the confidentiality Though health care accounted offices, hospitals, and others and integrity of patients’ pro- for only 1% of data breaches in began to exchange patient data. tected health information (PHI)

Ambulatory Surgery Advisory Board

Lee Anne Blackwell, BSN, EMBA, RN, Rebecca Craig, BA, RN, CNOR, CASC Rosemary Lambie, MEd, RN, CNOR CNOR CEO, Harmony Surgery Center, Fort Nurse administrator, SurgiCenter of Director, clinical resources and Collins, Colorado and MCR Surgery Baltimore, Owings Mills, Maryland education, Surgical Care Affiliates, Center, Loveland, Colorado ­Birmingham, Alabama LeeAnn Puckett Stephanie Ellis, RN, CPC Materials manager, Evansville Surgery Nancy Burden, MS, RN, CAPA, CPAN Ellis Medical Consulting, Inc Center, Evansville, Indiana Director, Ambulatory Surgery, BayCare Brentwood, Tennessee Health System, Clearwater, Florida Donna DeFazio Quinn, BSN, MBA, RN, Rikki Knight, BS, MHA, RN CPAN, CAPA Lisa Cooper, BSN, BA, RN, CNOR Clinical director, Lakeview Surgery Director, Orthopaedic Surgery Center President, Surgery Center, Samaritan Center, West Des Moines, Iowa Concord, New Hampshire Medical Center, San Jose, California

26 OR Manager Vol 27, No 8 August 2011 Ambulatory Surgery Centers

and personally identifiable infor- mation (PII). Data breaches in health care 2. Protect against threats to PHI Some recent examples: tor their personal information and PII. and credit reports after a main- 3. Protect against unanticipated Massachusetts General Hospital frame computer containing pa- uses and disclosures of that infor- in Boston pays a $1 million fine tient data was stolen from one of mation. in February 2011 to settle poten- the system’s outpatient facilities 4. Ensure compliance by the tial violations of the HIPAA pri- in a recent burglary.” ASC’s workforce with HIPAA and vacy rule. The fine involved the —Modern Healthcare, February other regulatory requirements. loss of documents with personal 14, 2011 A data security risk assessment information for 192 outpatients, is performed in two phases (side- including some with HIV/AIDS. “A Connecticut hospital says an bar, p 28). Wotowey suggests that The documents were lost in 2009 employee improperly took infor- the assessment follow the three when a MGH employee com- mation on 93,000 patients home types of safeguards outlined in muting to work left the docu- on a personal hard drive. the HIPAA Security Rule: ments on a subway train. They “The employee was fired, but • administrative safeguards were never recovered. the hard drive has not been • physical safeguards — www.hhs.gov found, Midstate Medical Center • technical safeguards. in Meriden told the Hartford Cou- (A sample checklist for assess- “Officials at St. Francis Health rant Monday.” ing these safeguards is in the side- System, Tulsa, Oklahoma, are — www.upi.com, April 6, 2011 bar.) Don’t overlook new types urging 84,000 patients to moni- of computer services and media, such as “cloud computing” (off- site applications), portable media breach. Insurance industry data breach. Elements of a plan in- like USB drives and cell phones, indicates the average cost of clude: and the ubiquitous social media. a breach at $500,000, Wotowey • legal advice says, though this is for large-scale • a notification plan for patients Closing the gaps events that are publicly reported. • public relations and media com- The risk assessment is likely to The University of Utah, for ex- munication uncover security gaps. For in- ample, had a serious breach in • credit monitoring for affected stance, you may find computer 2008 when backup tapes were patients workstations are left accessible for stolen from a car belonging to a • plans to cover patient claims long periods of time. Or perhaps vendor, exposing the data of 1.7 for reimbursement if they suf- your facility has started using a million patients. The price tag: fer identity theft and financial new off-site backup service for its $646,000 in printing and mailing, losses. files without taking a close look at $81,000 for a phone bank, and For planning purposes, the cost the contract and business associ- $2.5 million in credit monitoring of credit monitoring runs from ate agreement. service costs. $18 to $20 a month per person After gaps are identified, the There are also intangible affected, with an average of $225 next step is to set priorities based costs—loss of patient and physi- per person per year, multiplied by on the risks associated with the cian trust and good will, damage the number of persons affected by gaps, he suggests. That includes to the facility’s reputation, and the breach, Wotowey estimates. an analysis of the direct and in- employee time needed to respond Under the HITECH Act, a direct costs for closing the gaps. to the breach. health care organization that has Examples of direct costs are hard- a data breach must notify the af- ware and software needed to A breach response plan fected individuals. A breach af- reinforce data security. A major Part of the risk assessment is a fecting 500 or more people must indirect cost would be the cost plan outlining how the ASC will be reported to media outlets. The incurred if your ASC has a data respond in case of a security response plan should include a

August 2011 OR Manager Vol 27, No 8 27 Ambulatory Surgery Centers

Privacy and security Data security risk assessment safeguards Phase I “ Have a plan Conduct a privacy assessment. Examples of to plug safeguards: Evaluate employee training pro- the gaps. gram. Administrative safeguards Evaluate ASC policies for privacy • Designated security officer and data security. • Information system activity Evaluate vendor agreements and “ review policies. ity shares protected health infor- • Employee training program mation. Phase II Also be mindful of the caps on Physical safeguards Close any gaps discovered in coverage for data breaches in the • Facility access controls Phase I. vendor contract. The cap may • Workstation access controls not come close to covering the • Media controls (backup and Develop a breach response plan. cost of a breach, he notes. More- storage) over, if a data breach occurs, • Reusable device controls budget for retaining a PR firm and it is found that the vendor • Proper disposal of pro- to assist with media relations, breached its own insurance con- tected health information Wotowey notes. tract in the process, that insur- ance exclusion will likely extend Technical safeguards Risks of new media to the vendor’s clients, meaning • Encryption of data Be aware of the data risks created the ASC would be left with little • Automatic logoffs from by new media, Wotowey advises. if any coverage. workstations “Cloud computing” is one ex- • Unique user IDs and pass- ample. “This is an off-site appli- USB drives, cell phones, words cation, such as off-site backup, and social media where the software and data stor- Personal devices are developing Organizational age reside off the ASC’s prem- so rapidly that security plans have requirements ises,” he explains. Cloud appli- a hard time keeping up. • Business associate agree- cations have advantages because USB drives can travel in and ments they don’t require expensive soft- out of the facility easily and store • Group health plans: Con- ware and maintenance. But they gigabytes of data. A few things to tracts limit plan sponsor also have risks and HIPAA chal- look at: access to protected health lenges. • Identify which workstations information The data may be in the have USB drives activated and “cloud,” but the responsibility could be vulnerable. still resides in the ASC, Wotowey • Consider disabling external tos and videos on sites like You- stresses. “The data owner is the USB drives for workstations in Tube and Facebook. Many social responsible party, irrespective key areas such as the preoper- media users readily share details of the computing environment.” ative and postoperative units and opinions about their personal All of the HIPAA requirements and materials management. and work lives. still apply. He advises looking A Rhode Island physician closely at the business associate Challenging boundaries was disciplined and lost hospital agreement with the cloud-com- Cell phones and social media privileges in April 2011 for post- puting vendor. Such agreements challenge the boundaries of pri- ing Facebook comments about are required under HIPAA for vacy and confidentiality. Cell experiences with patients in the any vendor with which the facil- phones make it easy to post pho- emergency room. Though she

28 OR Manager Vol 27, No 8 August 2011 Ambulatory Surgery Centers

didn’t disclose patients’ names Though ASCs need a policy or confidential information, one for social media, Wotowey urges patient’s injuries were such that “ them to have the policy reviewed a third party was able to identify Be aware by legal counsel to be sure it com- the patient. The physician imme- plies with state and federal laws diately deleted her Facebook ac- of risks and regulations. Some state stat- count. Still, the state health de- of new media. utes limit an employer’s ability to partment found her guilty of “un- terminate an employee based on professional conduct” and levied off-duty conduct. a $500 fine. Given the growing role of com- “ puterized information in the lives Social media and atric patient. Her coworkers had of patients, physicians, and facili- employees posted supportive comments. ties, data security needs to be on Employers walk a fine line with The company fired the em- every ASC administrator’s priority social media policies. Employees ployee because it said the Face- list. ❖ have strong protections of their book post violated its policy rights to express opinions about against disparaging superiors on Resource their employers. the internet. But the NLRB said Department of Health and Human The National Labor Relations the policy violated the employee’s Services. Reassessing Your Security Board (NLRB) recently ruled protected right to engage in “con- Practices in a Health IT Environ- ment: A Guide for Small Health Care against an ambulance company certed activity” for “mutual aid Practices. http://healthit.hhs.gov/ that fired an employee who bad and protection.” The NLRB rules portal/server.pt?open=512&mode=2 mouthed her supervisor on Face- on matters for both unionized and &cached=true&objID=1173 book, implying he was a psychi- nonunionized employees.

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bese patients are nearly 12 times more who deserves to be OR likely to have postoperative complications Manager of the Year? Oafter elective breast procedures than non- obese patients, finds a study published online Then nominate him or her for Managing Today’s ahead of print in Plastic and Reconstructive Surgery. OR Suite’s OR Manager of the Year award! Overall, 18.3% of obese patients suffered com- plications compared to 2.2% of nonobese patients Each year, Managing Today’s OR Suite honors a manager or in a review of insurance claims data by Johns director as the OR Manager of the Year. The recipient receives Hopkins researchers. There were 2,403 patients in a complimentary registration to Managing Today’s OR Suite the obese group, and 5,597 in the normal weight and all expenses paid, including airfare, hotel and meals. The OR Manager of the Year award will be presented during the control group. The most common procedure was luncheon on Thursday, September 29. breast reduction.. With government and other insurers penal- To nominate a leader for the OR Manager of the Year, please izing physicians whose patients get infections write a letter of approximately 300 words describing why this person deserves the award. Additional letters are welcome. or are readmitted, “policymakers need to make The deadline to submit a nomination is August 5, 2011. sure they aren’t giving physicians financial in- centives to discriminate on the basis of weight,” You can submit your nomination online at www.ORManagerConference.com or mail your letter to: says the lead researcher, Martin Makary, MD. “Payments are based on the complexity of the Managing Today’s OR Suite procedure but not adjusted for the complexity of OR Manager of the Year the patient.” 4 Choke Cherry Road, 2nd Floor Rockville, MD 20850 18652 For more information: http://www.hopkinsmedicine.org/ Managing Today’s OR Suite ■ September 28 – 30, 2011 surgery/faculty/Makary Hyatt Regency Chicago

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At a Glance CMS proposes to increase quality reporting The Centers for Medicare and flation update of 1.5% for outpa- Reporting of outpatient Medicaid Services (CMS) pro- tient services in 2012. The ASC surgical infection rates poses new quality measures, update would be 0.9%. Hospitals and ASCs would need including a new quality report- —www.cms.gov. Look under to start reporting outpatient sur- ing program for ambulatory Newsroom. gical site infection (SSI) data to surgery centers (ASCs), in its —www.ascassociation.org CMS starting in 2013 for a full proposed 2012 outpatient rule payment update in 2014 if CMS issued July 1, 2011. The rule New ASC quality reporting finalizes its proposal. Hospitals applies to hospital outpatient program proposed will report inpatient SSIs starting departments and ASCs. Com- Under the proposed quality re- in 2012. ments are accepted until Au- porting program, ASCs would Infection rates would be re- gust 30. A final rule is expected need to report on 7 quality mea- ported using procedures set forth by November 1. sures beginning in 2012 to re- by the Centers for Disease Control Included are proposed pay- ceive a full payment update in and Prevention (CDC) using its ment updates for hospital outpa- 2014. Proposed measures for National Healthcare Safety Net- tient departments and ambulatory 2012 are: work (NHSN). surgery centers (ASCs). • patient burn Here are highlights. • patient fall Surgical safety checklist • wrong site, side, patient, proce- measure for 2014 ASCs ‘disappointed’ dure, or implant Hospital outpatient departments at proposed pay update • hospital transfer/admission and ASCs wanting to receive The ASC Association says it is • prophylactic antibiotic timing their full payment update from “extremely disappointed” that • appropriate hair removal Medicare in CY 2014 would have CMS proposes to continue to • prophylactic antibiotic selec- to report use of a surgical safety base ASC Medicare pay up- tion. checklist starting in 2013, CMS dates on the consumer price The first six were developed proposes. index for all urban consumers by the ASC Quality Collabora- CMS notes that the use of (CPI-U) rather than the hospi- tion. The seventh is a hospital such checklists “has been cred- tal market basket. Continuing and physician quality mea- ited with dramatic decreases in to use the CPI-U will further sure that would be applied to preventable harm, complications, widen the payment gap be- ASCs. ASCs would need to re- and postsurgical mortality,” tween hospitals and ASCs, the port using a special quality data as documented in 2 studies (N association says. code, under a system CMS is de- Engl J Med. 2009;360:491-499 and Hospitals would receive an in- veloping. 2010.363:1928-1937). ❖

32 OR Manager Vol 27, No 8 August 2011