SELECTED READINGS

IN

ORAL AND

MAXILLOFACIAL SURGERY

OFFICE-BASED

Mark D. Zajkowski, DDS, MD

Volume 20, Number 2 July, 2012 OFFICE-BASED ANESTHESIA

Mark D. Zajkowski, DDS, MD

INTRODUCTION

Oral and maxillofacial surgeons have practiced their specialty in office-based surgery­facilities for years, offering safe, convenient care for millions of patients. Recent shifts in medicine toward this model of care have created controversies among many stakeholder groups, and our specialty has been caught in the crossfire. While we have pioneered many advances in office-based anes- thesia, the landscape of current practice is changing as more and more parties of interest come to the table. Anesthesia, a key component of our practices, has a rich background that is forever intertwined with dentistry and oral and maxillofacial surgery. This issue of Selected Readings in Oral and Maxillofacial Surgery will focus on anesthesia in an office-based setting in particular. Rather than review common medications, dosages, and in-depth techniques, I will view anesthesia from a “30,000 foot level”, exploring our deep history as a specialty with anesthesia, the evolution of current-day standards, modern concepts of safety in medicine and industry, and a forecast of what the future holds for our profession. With this format, I hope to stimulate some thought on what each of us can do to improve patient care and how we view ourselves as part of the larger picture of medicine during an unprecedented era of cost containment, quality initiatives, and challenges to our autonomy. HISTORY Diethyl ether, for example, had been available for centuries but never applied for surgical use. Instead, it became known as a Surgery today without modern anes- cheap alternative to gin,5 and for its use at thetic techniques would be viewed as cruel “ether frolics”, where students would breathe and unusual punishment. Although the roots from an ether-soaked towel and experience a of modern anesthesia did not begin until the thrill. mid-1840s, it is important to realize that doc- umented procedures were actually recorded Similarly, nitrous oxide was used for in The Edwin Smith Surgical Papyrus.1 These recreational or entertainment purposes, but describe several dozen cases performed from less frequently than ether due to the difficulty 3000 to 2500 BC. Varying techniques of pain in preparation and storage of the gas. The first control were attempted, from nerve compres- preparation of nitrous oxide was completed sion2 to hypnosis (referred to as mesmerism)3 by Joseph Priestley, an English clergyman and refrigeration,4 all in an attempt to alle- and scientist.1 While Priestly is credited with viate patient suffering but with exceedingly the preparation of the gas, Davy was the first poor results. Multiple agents and techniques to study its effects on humans in great detail, over subsequent centuries had been attempt- culminating with his tome in 1800 entitled, ed with varying success, and some prominent Nitrous Oxide. Not coincidentally, Davy not- agents were initially overlooked. ed the “transient relief of a severe headache,

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obliteration of a minor headache, and briefly offered to be the subject of a dental extraction quenched an aggravating toothache”.6 Sadly, under the same protocol. When his tooth was despite his prolific research into the - prop extracted without pain, Wells was convinced erties of nitrous oxide analgesia, he is best of the therapeutic benefits of this technique.8 known for coining the term “laughing gas” to Colton showed Wells the technique of pre- describe its effects on human subjects. paring the gas, and Wells then used this with success in his dental practice. Later in the nineteenth century, one of the first reports of ether administration Emboldened by his success, Wells con- for surgical pain control emerged, although tacted John Warren, the chief of surgery at much later than it had actually occurred. On Massachusetts General Hospital. Warren March 30, 1842, Dr. Crawford Long deliv- ­arranged for Wells to lecture on pain preven- ered ether anesthesia for removal of two neck tion and to perform a demonstration of his lesions on his patient, James M. Venable.7 nitrous oxide technique for tooth removal Long ­described the trial in his recording: before Harvard Medical School students in “The patient continued to inhale ether dur- January of 1845. Unfortunately, the patient ing the time of the operation; when informed cried out during the extraction, and Wells it was over, seemed incredulous, until the was widely ridiculed, despite the fact that the ­tumor was shown to him.”7 ­patient did not recall having any pain during the tooth removal.9 Wells continued to work While Long was the first to use ether in with nitrous oxide, but never truly recovered this clinical setting, he did not claim credit from his failed demonstration in Boston. At for it until 1849, which he attributed to his the age of 33, Wells took his own life. practice in a rural environment and his lack of opportunity for a large series of proce- While Wells was practicing dentistry in dures. While Long was working with ether in Boston, William Morton joined him in prac- Georgia, a series of events in New England tice. During this time, Wells gave ­instruction began what many consider the birth of anes- to Morton in the delivery of nitrous oxide thesia as we know it. for dental procedures.10 Morton then later ­enrolled in medical school at Harvard and During the mid-1800’s, many patients met Charles Jackson, a physician and pro- deferred dental treatment for fear of signifi- fessor of chemistry. Morton had dropped cant pain. This, of course, was a problem for his focus on nitrous oxide and narrowed his dentists, who saw this as a threat to their live- ­efforts to using chloric ether as an anesthetic. lihood. On December 10, 1844, Horace Wells Jackson recommended the switch to sulfuric observed a demonstration, in an entertainment ether,9 and Morton became engrossed with setting, of the use of nitrous oxide by Gard- this new agent. ner Colton in Hartford, Connecticut. He was so struck by the volunteer who injured him- Eventually, Morton became confident self without pain while under the influence with this technique and began using it in his of nitrous oxide that he contacted Colton and dental office. On October 16, 1846, at the

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same site of Wells’ failed demonstration with Keep, the first Dean of the Harvard Dental nitrous oxide, Morton provided ether anes- School and an exceptionally talented dentist- thesia to Edward Gilbert Abbott for removal physician. Keep was a mentor to the young of a neck tumor by the Professor of Surgery, dentists Wells and Morton, allowing them John Collins Warren. At the conclusion of the ­access to his laboratory while they were procedure, the patient reported that while he ­enrolled in medical school. Some surmise was aware of the surgery he felt no pain. War- that Keep may have introduced Morton to ren then proclaimed the famous line, “Gen- Charles Jackson.13 tlemen, this is no humbug.”11 Shortly after Morton’s demonstration in Morton initially refused to tell his peers the in 1846, Keep and Morton what the inhaled substance was, naming entered a 10-year partnership agreement, but it “letheon”, and attempted to patent it for it only lasted a few weeks. Morton’s insta- personal financial gain. Naturally, Jackson bility and materialism was a likely wedge took issue with Morton’s claim as the man between the two, but Keep advanced the use who discovered ether’s anesthetic properties, and understanding of ether as an anesthetic ­despite a congressional committee’s uphold- in 1847. His publication in the Boston Medi- ing of Morton as the discoverer of ether. This cal Surgical Journal entitled “Inhalation of controversy carried on for several years, cost- Ethereal Vapor for Mitigating Human Suffer- ing Morton his entire wealth and personal ing in Surgical Operations and Acute Diseas- well-being. He died a pauper on July 5, 1868 es” documented the preparation, storage, and at the age of 49, while Jackson died in an ­administration of ether in his own delivery ­insane asylum, distraught over the prolonged apparatus.14 battle with Morton and his lack of recogni- tion in his role with ether anesthesia.9 On April 7, 1847, Keep administered the first obstetric anesthesia to Fanny Long- Eventually, all of these men were fellow, the wife of Henry Wadsworth Long- ­rewarded in the annals of history. Long was fellow. His societal standing and profession- recognized as the discoverer of anesthesia by al reputation surely helped the use of ether the American Society of Anesthesiologists, ­anesthesia gain traction in the United States with annual recognition of his accomplish- as a method to remove pain from surgery.13 ments on “Doctor’s Day”. Wells was recog- nized with the same honor by the Paris Medi- Dentistry Moves to Nitrous Oxide cal Society in 1847, the American Dental Association in 1864, and the American Medi- Ether and chloroform became the inha- cal Association 1870.12 Morton, of course, is lational anesthetics of the day in the 1850s also given credit due to his publication in the in medicine, but dentistry still favored chlo- Medical Examiner in December, 1846. roform, given the difficulty in storage and production of nitrous oxide. As the 1860s A crucial figure, who should not be for- moved on, a mixture of chloroform and ether gotten in this history, is Dr. Nathan Cooley became the favored anesthetic, but signifi-

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cant advances were finally being made with While still more pioneers perfected inha- nitrous oxide. lational anesthetic machines, Jay Heidbrink, a Minneapolis dentist, worked extensively­ In 1863, Gardner Colton (the same man on perfecting his nitrous oxide delivery who removed Wells’ tooth) helped nitrous ­machine and published a well detailed article oxide regain its prominence in dentistry. He in 1922 of his technique.15 In many ways, joined with two prominent dental surgeons in the work of Heidbrink markedly ­improved New York and formed the “Colton Dental As- the ­opportunity for patients to have an sociation”, which specialized in tooth extrac- 12 ­ambulatory procedure that was safe and pain tion under nitrous oxide general anesthesia. free. ­Despite these advances, the technique In this setting, Colton reported over 100,000 of ­using 100% nitrous oxide persisted until cases of 100% nitrous oxide anesthesia with 8 the 1950s. Seldin described the technique of no fatalities. The lack of morbidity from this inducing anesthesia to unconsciousness, and technique was attributed to the very short titrating the anesthesia to the specific shades duration of the procedure, minimizing the of blue seen in the skin coloration.16 At this ­effects of hypoxia on these patients. point, the mask was removed, and the proce- dure was completed as quickly as possible. Despite Colton’s remarkable safety ­record,9 Edmund Andrews, a Chicago sur- Fortunately, the agents and techniques geon, first presented the idea of mixing used in inhalational anesthetics evolved. One oxygen with nitrous oxide in 1868.9 Oth- of the most widely-accepted inhaled vola- er pioneers contributed to the widespread tile anesthetics for dentistry was halothane, ­acceptance of nitrous oxide, including Thom- ­appearing in the 1950s and lasting well into as Evans, a prominent dental surgeon in Paris, the early twenty-first century. Of course, the S.S. White in Philadelphia, and Sir Frederick formulation and use of this method of anes- Hewitt in England. Evans devised a way to thesia has continued to evolve, with the mod- compress the gas into a liquid form, easing ern use of sevoflurane in many of our offices storage and transport issues, and exhibited it today. at the Paris Exposition in 1869. This led to the widespread availability of compressed ni- The Influence of Oral Surgery trous ­oxide in cylinders in the United States. on Anesthesia In 1897, Hewitt was among the first to put it all together, creating the first machine In the early 1900s, no formal anesthe- that could deliver both oxygen and nitrous sia training was offered in dental schools, oxide. White patented a device similar to nor were there residencies for oral surgeons Hewitt’s in the United States. A physician to practice and train in general anesthesia. in Toronto, named E.I. McKesson, refined While medicine began the education and Hewitt’s work, offering an intermittent flow training in hospitals that eventually led to head that allowed a very precise flow of separate anesthesia departments dedicated to ­nitrous oxide and oxygen in varying percent- the education of future practitioners, dentists ages. were relegated to individual offices to learn

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techniques much like an apprentice would in dentists to provide anesthesia. Over the years, making shoes. the ADSA exerted significant influence on ­organized dentistry and led to improvements While the first medical department of anes- in hospital residencies for dentists interested thesiology was founded at the University of in anesthesiology. Wisconsin in 1926 by Dr. Ralph Watters, most dentists and oral surgeons were not allowed­ John Lundy, one of the leaders in medi- to participate in training at many of the other cal anesthesia, established one of the first developing departments at ­major hospitals ­departments of anesthesia at the Mayo Clin- and universities. It was not ­until the develop- ic. Sodium pentothal was developed in 1932, ment of oral surgery training programs in the and Lundy became the first to use the drug 1940s that residents gained ­access to training clinically in 1934, advocating for an intermit- with their medical colleagues, and the rapid tent bolus of the drug for general anesthesia. expansion of knowledge and breakthroughs During that time, outpatients rarely if ever for ambulatory anesthesia began. ­received general anesthesia.

A pioneer by the name of Leonard Mon- One of Lundy’s pupils was a dentist heim began his career as a dentist, graduat- named Adrian Hubbell, who became con- ing from the University of Pittsburgh Dental vinced of the ideal properties of the drug School in 1933. He later completed a three- for outpatient dental extraction. Lundy con- year residency in anesthesiology, and served sistently opposed Hubbell, and refused to as a staff anesthesiologist at St Francis Hos- ­administer anesthesia to any patient who was pital in Pittsburgh. When he returned from not admitted to the hospital overnight. serving in the Army in the South Pacific in 1946, he led the first independent Depart- Hubbell eventually completed his resi- ment of Anesthesia at the Pittsburgh Dental dency and returned home to Southern Cali- School as its Chair and also served as a pro- fornia, joining Berto Olsen, an exodontist, in fessor at the School of Medicine.17 He also practice. He steered Olsen from his nitrous led a one-year organized training program in oxide technique to intravenous pentothal, anesthesiology for dentists at Pittsburgh that demonstrating the superior anesthetic tech- provided applied basic science for oral sur- nique. He also used pentothal on longer cas- gery residents who had completed training in es, supplementing the pentothal with a 50% other hospitals. mixture of nitrous oxide and oxygen. One of Hubble’s innovations was a foot pump to He completely dedicated his career to ­deliver the pentothal, which eliminated the the teaching of anesthesia to dentists and oral need for multiple thiopental syringes and surgeons, and served as one of the founders freed the surgeon’s hands to remain in the of the American Dental Society of Anesthe- surgical field.18 siology (ADSA), an organization born from the increasing power of medical anesthesi- Hubbell eventually built a large facil- ology and its potential to limit the ability of ity in Long Beach geared to this technique,

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often delivering over fifty anesthetics per sively, omitting oxygen, nitrous oxide, local day. His facility became a “Mecca” for oral ­anesthesia, or monitors of any kind (other surgeons to come and observe the efficiency than observation of the patient). Clearly, a of the thiopental anesthesia technique for oral f­ocus on the teaching of standards in pain and surgery. Later, in the 1950s, Hubbell joined anxiety control was necessary for our profes- Harold Krough, an oral surgeon in Washing- sion to advance. ton DC, and taught a very influential series of courses on the delivery of thiopental anesthe- The American Dental Society of Anes- sia all over the country. This sparked the gen- thesiology was very influential during this eration of intravenous anesthetics delivered era and put on a number of national confer- nationwide, with varying updates and addi- ences on pain and anxiety control. This led tions to this technique over the years. to the “Guidelines for Teaching the Compre- hensive Control of Pain and Anxiety in Den- While Hubbell was helping to incorpo- tistry” that the American Dental Association rate thiopental for outpatient general anes- adopted in 1971. These guidelines have con- thesia in oral surgery, a dentist teaching at tinued to evolve over time, establishing stan- the Loma Linda University Dental School dards and ensuring adequate training in pain ushered in the era of conscious sedation. In and anxiety control among dental students, the 1940s, Niels Jorgensen pioneered the residents, and private practitioners. With the “Loma Linda” or “Jorgensen Technique” accreditation of dental anesthesia programs of sedation. This generally consisted of in the past several years by the Commission three drugs: pentobarbital, scopolamine, on Dental Accreditation, it is likely that den- and meperidine. The pentobarbital provided tal anesthesia will become a recognized den- the “base” sedation, while a 4:1 mixture of tal specialty. meperidine:scopolamine allowed a longer period of sedation. Increasingly safer and more effective pharmacologic methods for procedural seda- As less toxic amide local anesthetics, tion continued to be developed. The introduc- such as lidocaine, became available, the tion and widespread acceptance of diazepam, combination of a balanced sedation tech- however, led some to increasingly question nique with local anesthesia opened the door the risk of general anesthesia in the dental for untold numbers of phobic dental patients office, given the new availability of- sedat to ­finally realize pain- and anxiety-free treat- ing medications with a greater safety profile. ment. These new benzodiazepines could finally ­alleviate anxiety for many patients without Despite these advances and relatively the inherent risk of a general anesthetic. good outcomes, the typical preoperative workup for patients was seldom more than As drugs such as ketamine, fentanyl and a few passing questions about cardiac or re- methohexital became available, many prac- spiratory status. In the pre-1960s era, most titioners shifted the focus of their practice to oral surgeons only delivered pentothal exclu- a conscious sedation anesthesia, with excep-

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tional safety results, but with a blurring of the A milestone multicenter clinical trial line between sedation and general anesthesia. ­entitled “Relative Efficacy and Safety of Unfortunately, as the decades moved into the ­Intravenous Premedication in Dentistry”was early 1980s, more reports of sedation-related began in 1987 (funded by the NIH). It ­assessed deaths in the dental office began to appear. 1,000 patients having third ­molars removed These events and subsequent media coverage under general anesthesia via a double-blind, ushered in a new era of oversight and regula- randomized sample. The trial concluded that tion of office-based anesthesia as we know it. deep sedation was more effective than mod- erate, and both were safe when ­administered A NEW ERA OF PUBLIC AWARENESS by adequately trained personnel using appro- AND OVERSIGHT priate monitoring.12 Fortunately, the push for safety in oral In 1985, the National Institutes of surgery offices was well underway in the pri- Health (NIH) convened the “Anesthesia and vate sector as well. In 1968, the Southern Cal- Sedation in the Dental Office” consensus ifornia Society of Oral Surgeons developed conference.19 The participants at the confer- the first program to evaluate office-based ence pointed out the critical need for greater anesthesia and emergency management for research in dental anesthesia with regards to its members, making this program a require- epidemiology, drug efficacy studies, moni- ment for membership in 1970. In 1975, the toring of patients, behavioral and other non- American Association of Oral and Maxillo- pharmacologic approaches, environmental facial Surgeons adopted this program, and risk assessment, new drugs, and the need for made it mandatory for all state component resources to conduct this research. The con- societies to require this office evaluation for clusion of the conference was, membership in 1990. In 2003, the AAOMS House of Delegates further mandated recer- “The use of all effective drugs car- tification at least every six years to maintain ries some degree of risk, however small. membership. Available evidence suggests that use of sedative and anesthetic drugs in the Several studies of the safety of anes- dental office by appropriately trained thesia gave credence to oral and maxillofa- professionals has a remarkable record cial surgeons’ claims of a high safety profile. of safety. However, even this record can ­Lytle and Stamper reported a mortality rate of be improved as scientific knowledge 1 in 673,000 for general anesthetics in a sur- of dental anxiety and pain control is vey of Southern California oral and maxillo- ­expanded, as strong training programs facial surgeons in 1987.20 Similarly, D’Eramo at all levels of professional educa- noted one death, 1 in 1,733,055 anesthetized tion are ­developed, and as appropri- patients, in a survey of Massachusetts oral ate guidelines governing requirements surgeons in 1988.21 for dental office personnel, facilities, and equipment are promulgated and One of the most recent prospective ­adopted.” ­cohort studies of anesthesia in an oral surgery

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office setting was completed by Perrott et al. to pursue his passion for outcomes and per- with over 34,000 patients.22 Encompassing formance measurements that he so strongly the entire spectrum of anesthesia, they found believed in. He eventually published his a complication rate of 1.3 per 100 patients, work, detailing 337 patient admissions and with all complications deemed minor and treatment, and documented 123 errors in his self-limiting, and a patient satisfaction rate of publicly released book, A Study in Hospital over 94%. Efficiency.

Medicine Focuses On Safety The American College of Surgeons (ACS) announced the first “Hospital Stan- Particularly with anesthesia safety, med- dardization Committee” in 1912, based on icine has come full circle in the pursuit of Codman’s end result system. This committee, quality and transparency. This can be traced in testing its one page of minimum standards back to Dr. Ernest Codman, a Boston surgeon for hospital care, found that only 89 of the who was the first to attempt assessment of 692 hospitals surveyed met the standards.24 patient outcomes, in a process he described The list of standards, now known as the Man- as “end result system of standardization”23 in ual of Hospital Standardization, had grown 1910. to eighteen pages in 1926, and more hospitals were being surveyed on these standards. By This was a radical concept, and not 1946, the manual had expanded to 118 pages, ­embraced warmly by his peers at Massachu- and Congress took note. Passing the Hill- setts General Hospital. Codman followed Burton Act, Congress provided federal fund- each of his patients with meticulous detail ing for hospitals, but only if those hospitals with his “end result cards” that contained had acquired ACS certification.24 ­patient demographics, diagnosis, treatment, and the outcome of the case. He hypothesized As the need for certification grew, the that successful outcomes should be applied sheer volume forced ACS to find new spon- in a standardized way to other patients with sors, because the process became a financial similar conditions. This also meant that treat- burden for a single professional society to ment failures would be reviewed, and these bear alone. In 1951, the ACS, the American regimens would not be repeated on future Hospital Association, the American Medical patients. Most shockingly to his colleagues, Association, and the American College of he pushed to make the failures in treatment Physicians joined together to form the Joint public. Commission on Accreditation of Hospitals (JCAH).25 The first fees for surveys of hos- With his interest in outcomes, Codman pitals were not charged until 1964, when the also founded the first morbidity and mortal- cost was a flat rate of 60 dollars, plus one dol- ity conferences to openly discuss treatment lar for each additional bed up to 250 beds. failures. For his efforts, his clinical privileg- es were revoked. He later founded his own The JCAH continued to grow and hospital, named the “End Result Hospital” ­adjusted its mission from minimum standards

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for hospitals to a focus on sustainable quality. The “drift” of our specialty towards this This growth has added a host of non-tradi- form of certification can be traced to medical tional facilities to its accreditation standards events in the 1980s and 1990s. Medical anes- services, including psychiatric ­facilities, thesia in outpatient settings began to see the substance abuse programs, long-term care spotlight of an unforgiving press.27 As a result ­organizations, home health care, hospice care, of several highly publicized incidents in med- ambulatory surgery, office-based surgery and ical offices (particularly plastic surgery and others. In 1979, the American Dental Asso- gastroenterology) the public ­became much ciation became a corporate member, and still more interested in how safe outpatient anes- has a member serve on the Joint Commission thesia really was. The president of the Ameri- Board of Governors. can Society of Anesthesiologists formed the Committee on Patient Safety and Risk Man- With this growth and expansion came agement in 1984, partly as a response to the name changes to reflect the shift of the increasing public outcry, but also because ­organizational mission, changing to the Joint of the rise in professional liability insurance Commission on Accreditation of Health- premiums for anesthesiologists. care Organizations (JCAHO) in 1987, and the current name of the Joint Commission Shortly thereafter, in 1985, the Anesthe- (TJC) in 2007. With this increased scope sia Patient Safety Foundation was formed. of accredited facilities came a refocusing This organization brings together multiple on how facilities became accredited. In the disciplines with an interest in patient­ safety 1990s, surveys focused on organizational (e.g., the anesthesiologists, the Joint Com- performance processes. Currently, the focus mission, representatives from the FDA, of the accreditation process is the review of American College of Surgeons, and the outcomes and performance-based standards American Medical Association) with the structured around functions central to patient­ goal of conducting safety research and edu- care, ­effectively focusing on the quality of cation, providing patient safety programs and care ­delivered to the patient,26 including campaigns, and promoting the national and ­anesthesia care. ­Undoubtedly, Ernest Cod- international exchange of information and man would be proud. ideas. The Anesthesia Patient Safety Founda- tion’s influence continues to grow, publishing Of particular importance to the oral one of the most widely read publications on and maxillofacial surgery community is the ­patient safety, and continues to fund a num- rapid growth in accreditation of ambulatory ber of research grants to advance their mission surgery centers and office-based surgery and vision. A number of excellent resources ­facilities by the Joint Commission and other can be found on their website at www.apsf. national ­accrediting agencies. While some org. specialties have mandated accreditation or its equivalent, organized oral surgery has not, As the focus continued on patient safe- relying instead on self-regulation. ty, the American Medical Association, along

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with key corporate contributors founded the Standards, and the Statement on the Safe Use National Patient Safety Foundation (NPSF) of Propofol. in 1996. One of the key statements in their mission (as stated on their website, npsf.org) Current ASA Guidelines for Office- is “NPSF can make a long term, measurable based Anesthesia specifically address the difference by serving as a central voice, and ­administration of and facility for providing NPSF will lead the transition from a culture the anesthetic, with recommendations on of blame to a culture of safety”. quality of care and safety procedures within the facility. The document reviews clinical This statement is significant, and shows care guidelines that include patient and pro- where the culture of quality improvement cedure selection, perioperative care, moni- in health care is headed. Equally prescient toring and equipment, and emergency and within the vision statement from the NPSF: transfer procedures. These are in agreement “The system of health care is fallible and re- with the AAOMS parameters of care and the quires fundamental change to sustain”. Many updated office anesthesia evaluation. can argue that the fundamental change is well ­underway, as you will read later in this ­review. Advances in the safety of office-based anesthesia for medicine and dentistry are At around the same time as the found- the result of a number of factors. Certainly, ing of the Anesthesia Patient Safety Founda- there is no substitute for a vigilant surgeon tion, published standards for minimum intra- who practices within the standard of care in operative monitoring were begun that led to a responsible, cautious and ethical manner. the adoption of the ASA Standards on Basic Progress can also be cited in the development Monitoring in 1986.28 Over the years, the of standards cited above, from a variety of American Society of Anesthesiologists has sources. Technologic advances in monitoring produced many guidelines for anesthesiolo- have also allowed for a greater safety margin. gists and non-anesthesiologists alike, which are continually updated. In 1985, Harvard Medical School pre- sented “Standards of Practice 1: Minimal I strongly encourage you to explore the Monitoring” and in doing so, became one of ASA website at www.asahq.org to review the the first groups to set standards for safe prac- latest guidelines. While some statements may tice.29 These new standards applied irrespec- be counter to the current AAOMS guidelines, tive of whether the anesthetic was general, good suggestions to improve clinical care regional, or monitored anesthesia care. The are present, and should be at least consid- standards included: ered. Some of the more relevant guidelines that should be reviewed are: Guidelines for • Blood pressure and heart rate Office-Based Surgery, The Anesthesia Care recorded at least every 5 minutes Team, Guidelines for Ambulatory Anesthesia • Continuous ECG throughout and Surgery, Basic Anesthetic Monitoring the case

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• Continuous monitoring of traditionally been incorporated as a means to ventilation and circulation by assess ventilation, the participants depending more on either a precordial stethoscope or • Breathing system dis con- ­direct observation of chest rise. nect monitor with alarm • Oxygen analyzer with Many surgeons had resisted this moni- low concentration alarm toring technique due to the “open system” with oral surgery patients and a lack of con- • Temperature measure sistent carbon dioxide output with patients in ment our setting, but it is acknowledged that the wave form produced by the open system CO As the push for adherence to standards 2 sensing is an accurate reflection of ventila- grew, pulse oximetery and end tidal CO2 monitoring gained acceptance by the mid- tion, even if the absolute value of the mea- 1990s. As a result, by the late 1990s, medical surement is less precise that it would be in a malpractice claims for brain injury caused by closed system. Starting in 2014, however, the inadequate ventilation decreased from 25% AAOMS Office Anesthesia Evaluation will to 9% of all claims for brain damage or death mandate the use of capnography. The guide- with other causes remaining stable.30 Inad- lines state: equate ventilation decreased significantly During moderate or deep sedation when either a pulse oximeter or capnograph and general anesthesia the adequacy of 31 was used. ventilation shall be evaluated by con- tinual observation of qualitative clinical Medicine has continued in updating signs and monitoring for the presence of standards as the technology has become avail- exhaled carbon dioxide unless preclud- able, including monitoring of brain function ed or invalidated by the nature of the with devices such as the BIS monitor. While patient, procedure or equipment. initially used in operating rooms to prevent intraoperative awareness, these monitors Whether this addition to our standards have been shown to lead to earlier PACU will decrease outpatient morbidity and mor- discharge and discharge from an ambulatory tality remains to be seen, and, as with many facility.32 Nevertheless, these monitors have safety measures, results may be difficult to not yet reached universal acceptance and quantify for some time. are not currently considered to be part of the standard of care. Controversy With Delivery Of Propofol

Oral surgeons had benefitted from Despite the long and consistent safety the monitoring advances as well, rapidly record of anesthesia in oral and maxillofacisl ­incorporating state of the art technologies to surgery offices, challenges to the ­delivery ­improve safety. While oral and maxillofacial method persist. This is somewhat due to surgery offices had been at the forefront of “collateral damage” from the attempts by outpatient anesthesia, capnography had not the American College of Gastroenterologists

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(ACG) to remove the following statement THE CULTURAL SHIFT TO found on the package inserts in propofol con- OFFICE-BASED SURGERY tainers: “For general anesthesia or monitored anesthesia care (MAC) sedation, DIPRIVAN The advancements mentioned previous- Injectable Emulsion should be administered ly have contributed to the ability to perform only by persons trained in the administra- an ever-growing list of procedures in non-tra- tion of general anesthesia and not involved ditional settings, particularly among medical in the conduct of the surgical/diagnostic pro- specialists. As the push by third-party payers cedure.” to have procedures performed in an outpatient setting has increased, so too has the increase In comments to the FDA challenging the in complexity and duration of office-based ACG petition, the American Society of Anes- procedures, resulting in the need for deeper thesiologists asserted that the insert was cor- sedation, analgesia, and general anesthesia.33 rect, offered its own statement on the safe use As the number of office-based procedures of propofol, and issued a joint statement with grew, the difference between an office facil- the American Association of Nurse Anesthe- ity and hospitals or ASCs became more and tists. The statement read, more obvious, with a lack of regulation and oversight of private offices. Because of this “Whenever propofol is used for unregulated nature, the office-based surgery ­sedation/anesthesia, it should be admin- era has been referred to as the “wild, wild istered only by persons trained in the west of health care”.34 ­administration of general anesthesia, who are not simultaneously involved in As patient deaths and serious adverse these surgical or diagnostic procedures. events occurred, they were reported in the This restriction is concordant with spe- lay press, often in a sensational manner. A cific language in the propofol package Wall Street Journal article highlighted the insert, and failure to follow these rec- “crackdown” on doctors performing unreg- ommendations could put patients at ulated procedures in 2009.35 The data gath- increased risk of significant injury or ered from the American Society of Anes- death.” thesiologists closed claims project36 showed The controversy has waxed and waned, that 75% of injuries were due to respiratory particularly with the increase in ability of or drug-­related events (2:1 respiratory). The nurse anesthetists to provide itinerant anes- most common respiratory events were air- thesia services independent of anesthesiolo- way obstruction, bronchospasm, inadequate gist supervision. The push by nurse anesthe- ventilation, and esophageal intubation. Drug tists for economic benefit and increase in events were due to incorrect dosing or drug, scope has established an adversarial posi- allergic reaction, or malignant hyperther- tion with regard to all office-based facilities, mia.33 Of particular concern was the finding ­including office-based oral and maxillofacial that 50% of the ­reviewed claims were judged surgery practitioners. to have substandard care, and a full 46% of

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these could have been prevented with better ­office-based surgery, and California, - Penn monitoring. Even in the 36% of cases with sylvania, Rhode Island and Texas followed acceptable care, the postoperative care after suit in 1999. These states approached the reg- discharge was found to be inadequate. ulations with a wide spectrum, from a limited approach focusing on the number and quali- A study of pediatric care in office- fications of personnel and general require- based surgery settings found that perma- ments for the administration of anesthesia to nent neurologic damage or death occurred very specific regulations and prescriptions more frequently in this setting as opposed following American Society of Anesthesiolo- to hospitals.37 As in the ASA Closed Claims gists guidelines and the reporting of adverse Study, most events (80%) for pediatrics were events.38 ­respiratory and due to inadequate equip- ment or monitoring. Of particular note in In a follow-up report the next year, the this study was that the provider was often an same author noted that 24 states had either oral surgeon, periodontist or nurse anesthe- put regulations in place or were considering tist ­supervised by a dentist. The conclusion doing so, with some granting exceptions to of this paper was that providers should have accredited facilities or mandating accredita- airway management training as well as the tion by one of the three accrediting bodies.39 ability to resuscitate children. Currently in the oral and maxillofacial sur- gery spectrum, 34 states require (via statues On the other hand, Perrott, et al’s ­paper or regulations) dental practitioners to ­undergo on office-based outcomes for oral and max- an office anesthesia evaluation, while 9 rec- illofacial surgery showed a more favorable ognize the Office Anesthesia Evaluation complication rate of 1.3 per 100 cases, with (OAE) as the appropriate model for inspec- these complications being minor and self- tions, and only 4 replace a state inspection limiting.22 Despite this report and continu- with the OAE.40 ing ongoing efforts of our specialty to edu- cate those in medicine about our methods of Oral and maxillofacial surgery has ­anesthesia training, experience, and consis- begun to feel the same third party regula- tent positive outcomes assessment, the tide tory push, most notably in New York State is turning away from self-regulation of spe- in 2007, with the passage of legislation that cialty practices and more towards third party would have required dual-degree oral and oversight and public transparency. maxillofacial surgeons to have their practices accredited by either the Joint Commission, The office anesthesia evaluation, while the American Association for the Accredita- serving the oral and maxillofacial sur- tion of Ambulatory Facilities or the Asso- gery community well for decades, is likely ciation for the ­Accreditation of Ambulatory now ­obsolete and unlikely to prevent the Health Care. This legislation stemmed from ­encroaching tide of state regulations on our a commission that studied the quality of care ability to provide anesthesia. In 1998, New in outpatient settings.41 Fortunately, intense Jersey ­became the first state to regulate lobbying resulted in an exception made for

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oral and maxillofacial surgeons, as long as Is There a Role for Accreditation in OMS they practice within the scope of their dental Offices? license.42 Laskin makes a reasonable case both Because the waiver took over two years for and against outside regulation of oral and to be realized, a number of facilities in New maxillofacial surgery offices in two editori- York undertook the accreditation process, als published in Journal of Oral and Maxil- fearing a failure in the lobbying of the leg- lofacial Surgery.44,45 In his first editorial, he islature. This created a “fish in a barrel” sce- cites the moratorium on office-based surgery nario for the oral and maxillofacial surgeons in Florida based on a sensational series of in that state, many of whom paid exorbitant untoward patient outcomes, but references fees for consultants to become accredited by the ADA guidelines on teaching comprehen- a ­potential deadline. An excellent review of sive control of anxiety and pain control, the three different experiences undergoing this AAOMS office anesthesia evaluation, and process can be found in detail in a recent the AAOMS Parameters of Care as reasons Journal of Oral and Maxillofacial Surgery for the ability of the oral and maxillofacial article.42 surgeons to self-regulate. Nevada surgeons also were caught in The following year, he acknowledged the crosshairs of state regulations with the the rapid trend of regulation of medical passage of another law regulating office- ­offices and the opportunity for the oral and based surgery in 2009. This was triggered maxillofacial surgeons in practice to ensure by poor infection control in an endoscopy safe, efficient, quality care that can enhance center. While dentists and oral and maxillo- our practices. His final statement, By“ imple- facial surgeons were not directly involved in menting voluntary accreditation, we now the regulation, this statute requires each MD- have the opportunity to lead again in the or DO-operated ambulatory surgery facility ­future.” shows a remarkable turnabout in his to be accredited by a nationally recognized thinking, and must be given significant con- accrediting organization,43 with mandated sideration by the individual practitioner as ­reporting of complications, and stiff penalties well as organized oral and maxillofacial sur- for those not in compliance. gery societies and associations. These experiences should serve as a The delivery of anesthesia in our offices, wake-up call to our specialty that action to like everything we do, is framed within our move out of the “cottage industry” and more community standard of care and within best- into the current mainstream of transparent, practice guidelines. Contemporary practices accountable care with measured outcomes on base the standard of care on the AAOMS Pa- a facility-by-facility basis is needed. rameters of Care, completion of the Office

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Anesthesia Evaluation, the individual state Care, with material on emergency protocols permit or license to provide this care, and the and monitoring standards. practice within the anesthesia team model. The anesthesia team model is predi- While not a standard for clinical care, cated on a surgeon with at least two assis- the significance of adequate training of the tants, one of whom has no other responsibili- entire anesthesia team has also been rec- ties other than to monitor the patient during ognized by the Committee on Anesthesia anesthesia. The surgeon should be trained in of AAOMS. They developed the Oral and advanced cardiac life support (ACLS), and Maxillofacial Surgery Anesthesia Assistants the assistants in basic life support (BLS). Program to educate staff on basic sciences, The licensing and Office Anesthesia Evalua- systemic diseases and evaluation of patients, tion, of course, speak for themselves as basic anesthetic drugs and techniques, equipment ­requirements that need no further description. and monitoring, and emergency manage- ment. This was replaced with a certification WHAT AND WHY DO WE NEED TO program named DAANCE (Dental Anesthe- CHANGE? sia Assistant National Certification Exam) in 2008. It is hoped that by certifying our as- So, you may ask, if the oral and maxil- sistants, oral and maxillofacial surgery will lofacial surgery community has enjoyed such be performing in a best-practices model for an exemplary record of safety over the years, other specialties to emulate, as well as to gain has committed to maintaining standards that some political capital in defending our treat- meet the American Society of Anesthesi- ment model. ologists and American College of Surgeons At this writing, the latest AAOMS guidelines, and are continually modified as ­Parameters of Care was published in 2007, technology and science improve, what or with current updates imminent. Applicable why do we need to change? standards with regard to anesthesia contain updated definitions of sedation and general The simple fact remains that while 15% anesthesia, general standards, criteria and to 20% of all medical procedures are done considerations for anesthesia in outpatient in an office setting (with rapidly increasing facilities, special considerations for medi- percentages annually), over 90% of oral and maxillofacial surgery procedures are within cally compromised patients, and outcomes 46 assessment indices for deep sedation and our offices. As medicine expands the use general anesthesia. This document generally of the office-based model, and the resulting follows the American Society of Anesthesi- regulations continue to increase, so too will ologists guidelines for office-based anesthe- public scrutiny of the traditional oral and sia, with the exception of propofol delivery maxillofacial surgery model. As we have by the operating surgeon. The Office Anes- seen all too often in the past, a reluctance to thesia Evaluation manual is considered to be self-regulate and raise the bar only allows a companion to the AAOMS Parameters of those outside of the specialty to set it for us.

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It remains my opinion that if oral and researched in detail before an oral and maxil- maxillofacial surgery stays complacent, with lofacial surgery facility submits an applica- the attitude of maintaining the status quo, we tion for accreditation. will surely be swept into a tsunami of oner- ous third-party regulation without signifi- Advantages to becoming an accredited cant input. Lessons should be learned from facility include a clear demonstration to your the New York and Nevada experiences, and patients that you offer the highest level of ­action should be taken to accredit our facili- ­patient safety and care, a competitive edge ties. The era of “We’ve always done it this in marketing your practice, attainment of a way” or “We control the dental board” are ­national benchmark of quality, and the avail- foolish arguments that will doom our spe- ability of constructive educational opportuni- cialty to the loss of autonomy that we have ties for your office on surveys. The process worked so hard to preserve. also creates internal checks and balances to ensure safe and appropriate care is delivered. Currently, accreditation for an oral and maxillofacial surgery practice can be provid- Our office has been able to negotiate ed by the Joint Commision, the Association ­favorable insurance payments for our servic- for the Accreditation of Ambulatory Health es, with a premium added to payments due Care, or the American Associatiion for the solely to the accredited status of our facility. Accreditation of Ambulatory Facilities. Each The accrediting organizations also offer an organization maintains different standards, online search tool for patients to find accred- but there are significant consistencies in how ited facilities, and offer patient resources for they view an ambulatory or office facility’s the patient to partner with you in their care. organizational structure, governance, patient The Joint Commission offers an online pub- care, and monitoring of outcomes. There are licity kit to promote the accredited status of certain advantages and disadvantages within your practice, and has materials that can be each accrediting organization that should be downloaded for your media campaigns.

______TABLE 1: AREAS FOR WHICH THE JOINT COMMISSION OFFICE-BASED SURGERY PROGRAM SETS STANDARDS-BASED PERFORMANCE

Environment of Care National Patient Safety Goals Emergency Management Performance Improvement Human Resources Provision of Care, Treatment & Services Infection Prevention and Control Records of Care, Treatment & Services Information Management Rights and Responsibilities of the Individual Leadership Transplant Safety Life Safety Waived Testing Medication Management

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Figure 1. Example of a monthly report score from Validare, Inc.. (Images reproduced with permission from Validare, Inc.). ______TABLE 2: SERVICES AND REPORTS AVAILABLE FROM CONSULTANT WEBSITES Quality Improvement Studies Audits (allergy notation, biopsy specimens, infection control, legibility of records, etc.) Benchmark Studies (sequelae monitoring, medication error, perioperative times, post-op nau- sea and vomiting) Essential Internal Studies (cost of care/medical supplies, patient satisfaction, patient waiting times) High Risk Process Analysis (biopsy follow-up, abbreviation misuse, crash cart) Speciality Benchmarking (e.g., recovery room audit) Policy And Procedure Manual Review Administrative, anesthesia, clinical governance, infection control, personnel and safety/ADA policies and procedures Safe Task List Gives current items that are due for accreditation, such as internal audits, studies, re-creden- tialing, policy and procedure review. Includes overdue items that need immediate attention Forms Repository Includes forms to help with data collection for studies and audits, sample bylaws for your organization, clinical forms to help documentation, equipment and inspection checklists, perioperative checklists, links to specialty guidelines, emergency management drills, human resources forms, etc.

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process focuses on operational systems criti- cal to the safety and quality of patient care. The survey process evaluates actual care pro- cesses by “tracing” patients through the care, treatment and services they received. In addi- tion to the patient tracer activity, the surveyor also reviews key operational systems that directly impact patient care. These surveyors are health care professionals who practice in the ambulatory care field and have practical experience in similar settings. Often, the sur- veyor during site visits is a fellow oral and maxillofacial surgeon or dentist.47

Following the survey, the practice will receive a summary of findings, with ample time to make corrections if needed. Once any deficiencies are corrected, a final- ac creditation decision is made; maintenance of Figure 2: Example of a Quality Improvement Study ­accreditation is fairly straightforward. Calendar. ______Many accredited facilities retain a con- While the cost to become accredited sultant to help keep Joint Commission poli- varies among the agencies, the current ­direct cies and procedures updated, and keep prac- cost of accreditation by the Joint Commis- tices informed of changing standards. One sion as an office-based surgery facility is of the most useful benefits that consultants $3,130 for an on-site survey, with additional offer is the ability to perform self-studies fees for multiple locations. There are also and ­audits in many areas, with the ability to annual fees to remain accredited, currently benchmark your results to a national average. $1,340 per year or a three-year accreditation One such company, Validare, Inc.,48 offers cycle of $4,020. This brings the total ­direct monthly email that reports scores for your fees for a three-year accreditation cycle to practice and reminders to keep records, stud- $7,150. This does not include the fees to ies, and policies up to date, as shown in Fig- hire a consultant for the initial evaluation, or ure 1 (on. P. 18). This monthly score directly for ongoing maintenance of your accredited correlates with your chance of success should status. These fees vary widely, both among you encounter an unannounced survey. Links consulting companies as well as among the to some of the various services and reports accrediting organizations. available from the consultant website for practices are listed in Table 2 (on P. 18). The Joint Commission Office-based Sur- gery program currently sets standards-based One of the major benefits of using a con- performance in the areas listed in Table 1 (on sulting service is the ability to use their tem- P. 17). The Joint Commission accreditation plates for quality improvement studies. (Fig.

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2 on P. 19) These are scheduled throughout as the rest of health care has done. Shouldn’t the year, and many choices are available. To our facilities review “near misses” that could align your practice with current accreditation have resulted in harm to a patient in a logical, standards, a calendar of studies is posted, progressive manner to ensure it never hap- many of which have the ability to enter data pens again? Why can’t the vast majority of to benchmark your practice to a national pool oral and maxillofacial surgery practices give of data. an accurate infection rate for their facilities when asked? How do we explain multiple After review of the level of detail within medication errors in facilities if there is no these links, it is reasonable to conclude that formal medication management plan? an accredited facility has far more failsafe mechanisms in place to avoid adverse events In a Journal of Oral and Maxillofacial and raise the bar on patient care and safety. Surgery editorial, Assael made a strong case When comparing the ongoing continuous to incorporate the Joint Commission National process improvements that an accredited Patient Safety Goals into practice.49 Surely, practice lives by, it should be fairly easy to if modeling our practices along the practic- see how our current model could be seen as es that the Joint Commission encourages is outdated. While the Office Anesthesia Evalu- good, it should follow that the office-based ation may refresh a practicing oral and maxil- surgery model that we have been privileged lofacial surgeon in emergency drills every six to practice for so many years has room for years, it offers little in those areas of accredi- the improvement that accreditation can offer. tation in the above discussion, particularly in quality improvement, system-wide analysis In 2009, AAOMS commissioned a task and risk prevention. force to review the concept of the suitability of the current Office Anesthesia Evaluation This is not meant to malign a valuable and the potential role for accreditation in oral tool that has served our specialty well, but and maxillofacial surgery practices. While rather to serve as a wake-up call to our spe- this committee’s work is still ongoing, prog- cialty to do the right thing and move in the ress is being made towards working with one direction of transparency and accountability, of the accrediting agencies to tailor a program ______TABLE 3: APPLICABLE GOALS FOR A WELL-RUN OMS PRACTICE Redesign of care processes based on best practices Use of information technologies to improve access to clinical information and support clinical decision making Knowledge and skills management Development of effective teams Coordination of care across patient conditions, services and settings over time Incorporation of performance and outcomes measurements for improvement and accountability

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research found “a health care system that fre- quently falls short in its ability to translate knowledge into practice, and to apply new technology safely and appropriately.” One of the most salient points in the report was that medicine is using outdated systems to deliver care. That is, if we want safe, high quality care we will need to have “redesigned sys- tems of care, including the use of information technology to support clinical and adminis- trative processes”.52

Figure 3. James Reason’s Swiss Cheese Model of While the focus of these reports was System Error. (Reproduced with permission of BMJ largely aimed at chronic conditions in medi- ­Publishing Group) cine, there are applicable goals that a well- ______run oral and maxillofacial surgery practice for either certification with the Office Anes- typically already incorporates, and others thesia Evaluation as a central component, or that could be of benefit. (Table 3 on P. 20) developing an accreditation program specific for the typical oral and maxillofacial surgery James Reason, a British psychology practice, with the goal of making the process professor, published a seminal article that more friendly and approachable. addressed safety and human error.53 He ­describes two ways human error problems HOW DOES OMS FIT IN WITH THE can be viewed: the person and the system NEW CULTURE OF SAFETY AND approaches. The person approach (which TRANSPARENCY? is all too common in medicine) focuses on ­errors of individuals, placing blame on in- The 1999 report by the Institute of Med- attention, forgetfulness or moral weakness. 50 icine entitled, “To Err Is Human” was a The system approach focuses more on the landmark in a national reckoning to improve conditions that individuals work under, and patient safety. It concluded that tens of thou- works to build in defenses that avoid errors sands of Americans die each year from errors or lessen their effects. This approach under- in their care, and hundreds of thousands suffer stands that humans are fallible and errors are or barely escape from nonfatal injuries that a to be ­expected, even in the best organizations. truly high-quality care system would largely prevent. Medication errors alone, occurring He notes in his paper that it is often the either in or out of the hospital, are estimated best people that make the worst mistakes, and 51 to account for over 7,000 deaths annually. that “error is not the monopoly of an unfor- tunate few”. He also points out that errors or 52 In a follow-up report, “Crossing the mishaps tend to occur in recurrent patterns, Quality Chasm: A New Health System for hence the need for the system approach. Rea- the 21st Century”, the Institute of Medicine son’s Swiss Cheese Model (Fig. 3 ) of sys-

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TABLE 4: FIVE KEY PRINCIPLES SHARED BY HROS Preoccupation with failure: every error or near miss is reviewed to address system failures. Reluctance to simplify: does not allow a process to rely on a single person without redundancy. Sensitivity to operations: encourages situational awareness and information sharing. Committed to resilience: ability to recover from a system failure and limits its effects Deference to expertise: Those with the most relevant skill set are empowered to fix problems. ______tem accidents shows how a series of weak- Reliability Organizations (HROs). These nesses in a system’s defense must “align” to are defined as institutions where individu- result in an untoward event. als, working together in high-acuity situa- tions and facing great potential for error and In our offices, for example, there are ­disastrous consequences consistently deliver many defense layers that are technology- positive results.54 based (such as alarms, physical barriers, etc.), person-based (doctors, nurses, clerical staff), The goal of these organizations, ­besides procedural-based, and administrative in high reliability, is the tenet of constant ­nature. While any one of these “layers” could ­improvement (as in auto manufacturing with potentially prevent the wrong tooth from be- the Six Sigma model of continuous quality ing extracted, for example, a series of errors improvement to reduce the rate of defects). in the system could leave this potential error In health care, this should be a reflexive ten- undetected until the adverse event happened. dency, stemming from our training in the sci- entific method.55 Two overriding principles Reason surmises that almost all adverse in quality improvement are the use of mea- events that occur involve a combination of surement tools to eliminate inappropriate active failures and latent (system) conditions. variation (known in medicine as the “art” While adverse events will occur in any set- of practice, i.e., without grounded scientific ting, the best practices make their systems as ­rationale) and to document the continuous reliable as possible and follow the models we improvement (via outcomes).56 will discuss below. HROs consistently maintain two major Office-based anesthesia involves a high- themes:57 anticipation (constant vigilance risk environment that requires significant for potential error sources as a cultural base- cognitive function, dynamic tasks, chang- line) and containment (immediate actions ing technologies, and time pressures while taken to reduce further damage when an error avoiding catastrophic events. In military and is identified). HROs also share five key prin- industrial areas like this (such as an aircraft ciples.58 (Table 4) carrier, a nuclear power plant or air traf- fic control) systems have been formed with A HRO treats “near misses” as a gift, great effectiveness that are exceedingly reli- because they occur 3 to 300 times more fre- able and safe. These are referred to as High quently than adverse events, and can rapidly

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allow data collection on the system in ques- out where the weakness in the system resides tion, and act as powerful reminders of system that allowed the event to happen. As Mer- hazards.58 HROs have developed the “knack” rill and Laur note:60 “Effective leadership of of converting these occasional setbacks into an ambulatory surgical center requires that system-wide reviews and a more resilient leadership emphasize constant improvement care system. This method of continual assess- in the process of care to achieve maximum ment and improvement makes systems (such patient safety and satisfaction, delivered with as anesthesia in an office-based surgery set- the highest efficiency.” ting) more reliable, consistent, and produces better results. Barach notes that several complex, non-medical industries have developed The Institute of Medicine report, men- ­robust ­reporting systems for near misses that tioned above, noted that “health care is a are confidential and emphasize the system ­decade or more behind other high-risk indus- ­approach for data collection, analysis and tries in its attention to ensuring basic safety.” ­improvement.61 In office-based anesthesia, In fact, one of the recommendations specifi- standard protocols for anesthesia delivery cally made in the Institute of Medicine report and care should be easy to build and deliver. was for health care to adopt team training By becoming an HRO, the oral and maxil- programs modeled on the crew resource lofacial surgery team can enhance the safety management used in the aviation industry, for their patients and make their offices ever as well as incorporation of simulation-based more sustainable in both a business sense training.54 Similarities between this and the and in a political sense, because we would anesthesia team model should be appreciated. no longer be “low hanging fruit” to a legis- lature seeking to “do something”. This pro- Some of the positive benefits of crew cess shifts the identification of problems as resource­ management are to produce positive an ­individual’s “fault” to a “system defect”. change in organizations, promote changes in When this culture takes hold, members of the behavior, and make learning more effective.59 team can truly work together­ for the common Crew resource management incorporates goal of safe, effective care. team training sessions, simulation, group ­debriefings, and performance measurement Oral and maxillofacial surgeons have of the crew involved. As an organization clearly heeded the call to improve skill sets perfects this concept, they can potentially and participate in team training. This is seen ­become a high reliability organization. This by the increased use of patient simulation pro- is exactly what has happened in aviation, and grams for residents and practitioners alike. the parallels in anesthesia are easy to see. While many current oral and maxillofa- In accredited organizations, this is cial surgeons have participated in some type ­referred to as a “failure mode analysis” of simulation in preparation for an Advanced where breaking down an adverse outcome Cardiac Life Support (ACLS) course or does not blame an individual, but rather finds through programs provided by the AAOMS

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Figure 4. First segment of an anesthesia record. (Image courtesy of Carestream Dental, LLC) ______Committee on Anesthesia, technology con- on the input of the user, and now are the tinues to improve to the point that teams can ­basis of the modern Human Patient Simula- train around surgical events and simulate the tor (HPS). Residents can now train on high effects of an anesthetic. ­fidelity HPS machines that allow simulation of heart and breath sounds pulses, ventila- Simulation dates back to the ancient tion, carbon ­dioxide exhalation, and arterial, ­Romans, when soldiers practiced for battle on central venous­ and pulmonary artery pressure a wooden model of a soldier.62 Medical simu- as well as allowing management of the air- lation has advanced from humble ­beginnings, way by mechanical means.62 when simple mannequins were used for CPR training. As technology has ­advanced, the The ability to extend this technology to simulation models have incorporated model multiple remote users has also become popu- theories that integrate mathematical equa- lar via virtual-world simulation through the tions to simulate multiple responses based internet.63 These were first developed by the

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Figure 5. Second segment of an anesthesia record. (Image courtesy of Carestream Dental, LLC) ______military for deployment of troops in Iraq, maxillofacial surgery office, especially when and were revised for training for responses it comes to office-based anesthesia. One of to chemical, biologic, radiologic-nuclear, the major initiatives in healthcare has been to and explosive incidents.63,64 The advantages convert to electronic medical records. These of multiple users in remote locations and records, coupled with improvements in mon- the flexibility of creating an online “immer- itoring systems can help us incorporate the sive” experience show unlimited potential for above-mentioned elements into our practices training of health care and industrial profes- to ensure a high level of care, and can help us sionals worldwide. apply the quality and error reduction models mentioned previously. PUTTING IT ALL TOGETHER… WHERE DO WE GO FROM HERE? Below, are some sample screen shots Bringing these elements of best prac- from an anesthesia record (within the ­patient’s tices together can be done in the oral and electronic medical record) to tie some con-

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Figure 6. Third segment of an anesthesia record. (Image courtesy of Carestream Dental, LLC) ______cepts together. These, in combination with a listing of providers, and a failsafe checkbox system approach to error reduction and the to ensure a completion of informed consent. elements within an HRO can show signifi- cant benefits to the practicing oral and maxil- It also identifies the American -Soci lofacial surgeon. ety of Anesthesiologists classification of the ­patient. The value of this particular tab is the incorporation of the team in the care process, This anesthesia record is divided into and the provision of another opportunity for different segments, following a logical se- the assistants and surgeons to confirm the quence that corresponds with the appropriate patient’s medical history and allergies, and steps in patient care and team flow during a answer any questions before the consent is case (all images courtesy of Carestream Den- signed. tal, LLC). Let’s begin with the first segment, shown in Figure 4 (on P. 24). It allows a quick The documentation of these key ele- review of medical conditions and allergies, a ments can also be helpful in risk management.

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Figure 7. Fourth segment of an anesthesia record. (Image courtesy of Carestream Dental, LLC) ______Consider how these steps can be done in our Figure 6 (on P. 26) displays the record- offices, much like the initial “checklist” that ing for the surgical “time out”, assurance of pilots review before initiating a flight. the correct patient and procedure, and mark- ing of the operative site (performed on the Figure 5 (on P. 25) shows the benefit digital film in a separate window). It also of importing monitored data at the onset of allows the recording of IV sites and type of the patient visit. This segment documents the catheter. These steps are critical to involve preoperative baseline vitals that are automati- the entire surgical team, much like in the re- cally imported from the monitors, and allows view of crew resource management discussed the doctor to record the pertinent findings on earlier. the preoperative evaluation, as well as the documentation of extremity positioning to The chronologic time details are avoid pressure injuries, and the use of safety ­automatically entered from the monitor at belts or any other items deemed appropriate. the completion of the case. Many of these

SROMS 27 VOLUME 20.2 Office-based Anesthesia Mark D. Zajkowski, DDS, MD

Figure 8. Fifth segment of an anesthesia record. (Image courtesy of Carestream Dental, LLC). ______­elements incorporate the National Patient the incorporation of a graphical user inter- Safety Goals from the Joint Commission, and face that allows an easily read printout to be are easily and seamlessly incorporated into made. The ECG is recorded at the beginning the patient record, and include the culture of of the procedure and stored within the anes- safety in an oral and maxillofacial surgery thetic record for review should the monitor ­facility. show changes, allowing a comparison to the baseline.

The section below (Fig. 7 on P. 27) is The times are either manually entered one of the most exciting portions of the elec- by the staff, or can be easily imported auto- tronic anesthesia record, because it allows matically, should the team wish. If doses of real-time recording of the patient’s vitals dur- medications are provided during the case, ing anesthesia, without the team members they can easily be added to the record, allow- being distracted from the patient’s care. Note ing a “real time” recording of events. Typical

SROMS 28 VOLUME 20.2 Office-based Anesthesia Mark D. Zajkowski, DDS, MD

Figure 9. Sixth and final segment of an anesthesia record. (Image courtesy of Carestream Dental, LLC) ______combinations of medications tailored to your The final page of the record (Fig. 9) individual practice can be created, easing the documents the finer points of recovery. The use of the record and improving efficiency. Aldrete recording sheet that is used for col- lection of data is later scanned into the an- At the conclusion of the case (Fig. 8 esthetic record after completion, and is used on P. 28) the surgeon stops the recording of during the follow-up phone call to the patient data and imports a final set of vital signs to on the following day. This allows the patient the record. At this point, he or she can make another opportunity to review postoperative notations on any complications or anesthetic care, ask questions and ensure that they are events. On this tab, the discharge vitals are recovering as expected. later entered in the recovery room, as well as documentation of the escort and instructions provided for postoperative care.

SROMS 29 VOLUME 20.2 Office-based Anesthesia Mark D. Zajkowski, DDS, MD

CONCLUSIONS Dr. Mark Zajkowski is a graduate of the University of Florida, the UCLA School of Dentistry, and Harvard Medical School. Oral and maxillofacial surgeons have He completed his residency in oral and max- contributed in significant and meaningful illofacial surgery at Massachusetts General ways to the progress in anesthesia for well Hospital in 1999. Mark is a partner in a four- over one hundred and fifty years. We can be doctor practice in South Portland, Maine that proud of our long track record of safety in our practices the full scope of the specialty, and offices, and the initiatives that we have cham- became voluntarily accredited by the Joint pioned to improve patient care. Times, how- Commission in 2006. Dr. Zajkowski is active ever, are changing, and with the increased in organized oral and maxillofacial surgery, scrutiny of office-based anesthesia from a having served on numerous committees and multitude of sources, we must raise the bar task forces. on how we provide care. Mark’s interests outside of the special- As medicine has begun to adopt indus- ty include the study of business and health try best-practices as done in aviation and care policy, as well as cooking, boating, and the military, our specialty should embrace ­exploring the coast of Maine with the love of the ­opportunity to again lead the way in this his life Michele and their two children. This new era of patient care. Outcomes-centered issue of SROMS is dedicated to them. practices, with transparency in the quality and safety of the care delivered, the devel- opment of a blame-free culture to improve our systems of care, and the modeling of our practices after high-reliability organizations offer the best chance for our specialty to leap forward and preserve the autonomy that we have worked so hard to gain.

While politically challenging, we should seriously consider the accreditation of our ­office facilities by an outside agency to spur our colleagues to improve the quality of care and shift the culture to a patient-centered ­organization that produces the right outcomes for the right patients all of the time. To offer anything less to our patients undermines not only our credibility, but undermines the work of the pioneers in oral and maxillofacial sur- gery before us.

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RELATED ARTICLES IN SELECTED Risk Prevention for Oral and Maxillofacial READINGS IN ORAL AND MAXIL- Surgeons. Alan E. Deegan, DDS, MSD, LOFACIAL SURGERY Selected Readings in Oral and Maxillo- facial Surgery . Vol. 6, #1, 1998. Pediatric Outpatient Anesthesia and ­Sedation. Vasiliki Karlis, DMD, MD, Pediatric Outpatient Anesthesia. Jeffrey B. FACS; ­Rachel Appelblatt, DDS; Lau- Dembo, DDS, MS. Selected Readings ren Bourell, DDS; Robert S. Glick- in Oral and Maxillofacial Surgery . Vol. man, DMD, Selected Readings in Oral 5, #4, 1996. and Maxillofacial Surgery. Vol. 18, #2, 2010.

The Electronic Health Record in Oral and Maxillofacial Surgery. Paul A. Daniel- son, DMD. Selected Readings in Oral and Maxillofacial Surgery . Vol. 17, #1, 2009.

Outpatient Orthognathic Surgery Performed in the Office Setting. Scott Blyer, DDS and Douglas P. Sinn, DDS. Selected Readings in Oral and Maxillofacial Sur- gery . Vol. 15, #6, 2007

Contemporary Ambulatory Anesthesia in Oral and Maxillofacial Surgery. Wil- liam L. Chung, DDS, MD; Mark F. Sosovicka, DMD; Bernard J. Costello, DMD, MD. Selected Readings in Oral and Maxillofacial Surgery . Vol. 12, #6, 2004.

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SROMS 35 VOLUME 20.2 SELECTED READINGS IN ORAL AND MAXILLOFACIAL SURGERY

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