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OPERATING ROOM AND PERIOPERATIVE SAFETY A Beginning Roadmap for Action

Prepared for Telemedicine and Advanced Technology Research Center United States Army Medical and Materiel Command Fort Detrick, Maryland

by Stephen C Schimpff, M.D. Columbia, Maryland April 30, 2005

Contract # W81XWH-05-P-0531

OPERATING ROOM and PERIOPERATIVE SAFETY Table of Contents Executive Summary Introduction Setting the Stage Overview of the Problem Why Focus on the Perioperative Environment? General Concepts About Safety in the Operating Room Specific Issues for Concern in the Perioperative Environment Patient Identification Medication Safety Infection Control Intraoperative Factors Anesthesia, Positioning, Electrical Safety, Fire Safety, Endomechanical Devices, Critical Variable Monitoring, Imaging Safety, Standard Protocols Patient Transport Post Anesthesia Care Unit Supply Chain Communication Patient Identification, Hand Offs, Safety Checks, Asleep Patient Operating Room Environment Insular, Technology Driven, Productivity Driven, Culture of Hierarchy, Tense, Profit Center, Experience, Training and Alertness Available Data on Patient Safety University Hospital Consortium Quality Indicator Project (QIP) Other Data

Conceptual Approaches to Patient Safety Approaches to Enhancing Patient Safety in the Perioperative Environment Environment of Safety Institutional Commitment Resource Allocation, Error Reporting Systems, Process Improvement Approach, Root Cause Analysis Human Factors to Enhance Patient Safety Leadership, Management, Teamwork, Culture of Safety, Read Back, Near Miss and Error Reports, Variation Reduction, Information Transfer, Training, Surveys, Mandates Technology Factors to Enhance Patient Safety Patient Identification, Electronic Medical Record, Surgical Information Systems, Video Technologies, Supply Chain, Simulation, Robotics Organizations Joint Commission on Accreditation of Healthcare Organizations American College of Surgeons Anesthesia Patient Safety Foundation University Hospital Consortium Health Care Advisory Board Agency for Health Care Research on Quality Medication Error Reduction as a Model Program Current Approach New Approach Summary Concluding Comments Recommendations to TATRC The Roadmap

Executive Summary Developing a roadmap for action in OR suite and perioperative safety. The United States Army Medical Research and Materiel Command through its Telemedicine and Technology Research Center (TATRC) has embarked on a five year research agenda devoted to the Operating Room of the Future. The research agenda has five major elements, first among them being to enhance patient safety. TATRC wishes to advance the patient safety agenda and to do so requires a clear roadmap for its partners and collaborators. In data from the American Hospital Association, 17 30% of patients had one or more serious adverse events. Convert this to a typical 350-bed community hospital with about 14,000 admissions and 5,400 surgeries and there will be 4000 serious adverse events each year. By rank order in this hypothetical American hospital the following adverse or unexpected events will occur: 884 patients will have an adverse drug event, 816 a nosocomial infection (i.e., an infection acquired in the hospital), 696 a procedural complication, 544 an unplanned readmission, 408 a decubitus ulcer, 299 will die, 204 will have a fall and 163 will have an anesthesia complication. (Combining the procedural, anesthetic, surgically-related nosocomial infections and the surgically-related medication errors leads to the conclusion that the perioperative environment is the location for the greatest number of adverse events.) The University Hospital Consortium began a self reporting system a few years ago. As of late 2004, 60 academic hospitals had recorded 71,000 events of which 6219 (8.7%) occurred in the OR environment. The most common errors were those related to a procedure (2200), a complication of a procedure (600), a break of skin integrity (180), an equipment issue (400) or a medication error (200). [Values rounded] Those related to the greatest ultimate harm were: skin integrity and complications of procedures. What is to be done to prevent these types of errors from occurring? The Institute of Medicine (IOM) in a landmark publication in 1999 wrote that as many as 44,000 to 98000 Americans die as the result of avoidable errors in hospital each year. These are incredible numbers and many have disputed them. (A more recent study reported in July, 2004 suggested that nearly 200,000 Americans die each year of medical errors.) But even if only half or ten percent occur actually occur, it is way too many. The IOM report was entitled To Err is Human, a very appros title since that is the basic problem. Humans make mistakes. Humans will continue to make mistakes. Well-educated and well-trained humans will make mistakes. Humans that double check will still make mistakes. The author of this report has interviewed surgeons, anesthiologists, nurses, hospital executives; reviewed literature; talked to leaders at organizations such as the University Hospital Consortium, JCAHO, Health Care Advisory Board and others. This has lead to s

report on the predisposing factors to perioperative errors, an understanding of the errors that occur and some initial thoughts on approaches to enhance patient safety. What follows are the authors thoughts, based on these interviews and reviews, on improving safety in the perioperative environment and what TATRCs partners and collaborators might do to engage this issue.

A successful approach to improving the safety of the OR and its environment will depend on attention to creating an environment of safety and then focusing on both human factors and technology factors. Environment of safety refers to the commitment of the CEO and Board to safety, to the needed investments, to a nonpunitive environment, and to a reporting and analysis feedback system. Human factors must include leadership, management, teamwork, information transfer, training and the creation of a culture of safety. Technology factors can include: surgical/operating room information systems; video capabilities, identification devices for patient, staff, equipment, instruments and medications such as bar-coding and RFID; simulation approaches and robotics. Information systems include not only the electronic medical record but the surgical system, the anesthesia system, the supply chain system and the PACS system all interconnected, wireless, easy to use, with built in prompts and alerts, with built in knowledge and built in surveillance. Video includes in room cameras for distant command and control of the OR suite, light source cameras to train, teach and record data and for teleconsulting and PACU/ICU cameras for electronic monitoring at a distance. Identification devices barcode and RFID can be used to track equipment, supplies; to identify the patient and the intended site of operation and procedure; to track staff and to record, document, and bill and order post use of medication or device. Simulators can enhance safety by training individuals for a particular procedure and for use of particular devices; by allowing the surgeon to preplan the best approach and procedure for the particular patient; to rehearse surgery and to provide team training in contingency planning and crisis management. Robotics can enhance patient safety by, at least, integrating patient-specific data; allowing less invasive surgery (e.g., CABG), allowing more accurate surgery (e.g., craniotomy); developing preplanned and rehearsed surgery; and having built in alerts and detectors.

In summary, the perioperative environment is a high risk area with high velocity, high complexity and high stakes; OR errors lead to disproportionately more harm than errors elsewhere in the hospital. There is a need to create an environment of safety and then address both human factors and technology factors when designing patient safety initiatives. The environmental factors include an institutional commitment, resources, a non punitive attitude, data collection and root cause analysis and systems approaches. Human factors include especially leadership, management, training and teamwork. Technology approaches include information systems, identification mechanisms, video, simulation and robotics. TATRC is anxious that its partners and collaborators actively engage in research to enhance patient safety in the OR and the perioperative environment.

Introduction The United States Army Medical Research and Materiel Command through its Telemedicine and Technology Research Center (TATRC) has embarked on a five year research agenda devoted to the Operating Room of the Future. The research agenda has five major elements, first among them being to enhance patient safety. Despite the prominence of this agenda item, most OR OF THE FUTURE research efforts by TATRCs partners has, TATRC FIVE YEAR STRATEGY PLAN to date, been focused on other elements such as new technologies. TATRC wishes PATIENT SAFETY to advance the patient safety agenda and to TELEMEDICINE do so needs a clear roadmap for its INFORMATICS partners and collaborators. This report will ADVANCED DEVICES set out the issues, directions for research, PERIOPERATIVE SYSTEMS DESIGN obstacles to success, and a proposed outline for future work. It includes the steps needed to initiate a functional and successful process for a program in safety; will order the work from simple to more complex and from that doable with todays technology versus that which will need to depend on technology not yet fully operational; and will establish the benchmarks necessary to hold partners and collaborators accountable, including measures of success. It is recognized that TATRC is inherently technology oriented; this report will nevertheless approach the problem in a broad sense looking at all of the issues and approaching the research agenda from a similarly broad perspective This report is qualitative, being based on a review of the literature and interviews of officials at national organizations interested in safety issues plus interviews with a wide array of surgeons, anesthieologists, nurses, others involved in the perioperative environment, hospital managers involved with safety agendas, executive level hospital managers and TATRC personnel. The next steps will need to be quantitative to develop the specifics data on errors in the OR and the perioperative environment and the process improvements that will be needed to improve safety. That said, there are some obvious approaches to improving safety now (better communication; team building; leadership; identification technologies like bar coding and RFID for patients, staff and equipment/ instruments; robust surgical information systems with wireless capability and built in alerts and knowledge; simulation devices to improve training in high risk procedures; and robotics, to name a few.) These techniques can be begun even while more basic studies are underway to more fully define the safety problems inherent in the operating room and perioperative setting.

iSetting the Stage A gentleman in his 60s was discovered to have early stage prostate cancer, treatable by either surgical resection or by brachytherapy (seed implants into the prostate.) After much gathering of data from his physicians and personal soul-searching, he made the decision to go with brachytherapy. Through a friend who was a major donor to a particular cancer center, he chose that center due to its reputation for excellence in this procedure and overall excellence in care of patients with prostate cancer. All was ready in the operating room. He was given spinal anesthesia while the urologic surgeon and radiation oncologist checked out their equipment. The procedure was to benefit from the use of a rectal ultrasound probe so that the team could be certain of where the seeds were placed in the prostate. Further, they were to use a device that held the needle in a fixed position that allowed insertion of the seeds with great accuracy. To their surprise, they found that the needle stylus was bent and certainly not usable. However, another full set of equipment was in the OR and ready for use. So they proceeded with the procedure using the stylus from the other set. At completion, they discovered that one seed was left behind in each of the many needles used. They then realized that the new set was a different model with a stylus that was shorter, hence leading to improper placement of the seeds. Since the procedure produces local inflammation and swelling, now was not the time when they could go back to inset the missing seeds; that would have to wait some weeks. Meanwhile, the patient was less than happy that he had chosen this institution only to have received a botched procedure for a serious disease. What went wrong? Everything. Purchasing had not thought that the cheaper model would be of any problem and did not notify anyone that it was a different model. Biomedical and Central Sterile Supply did not cross check the new purchase with the prior equipment for compatibility. The scrub technician did not realize that he had two different models of equipment. And the physicians never thought to double check that they had identical equipment. So all the checks and balances that should normally assure safety were not effective; in short, there was no organized system in place to assure quality and safety. The patient, by the way, chose to go elsewhere for followup therapy. Overview of the Problem We all assume that our healthcare provider will not make mistakes, at least not when treating us. But doctors, nurses, physical therapists, pharmacists, etc are all human and are endowed with a common characteristic, namely, they all make mistakes just like the rest of humanity. Certainly, no one comes to work in the morning determined to make a mistake; indeed, a lot of effort and energy goes in to not making a mistake but it still happens. A study from Harvard Medical School published in the prestigious New England Journal of Medicine in 1991 by Leape and colleagues found that about one half of actual injuries

to patients at a major Boston hospital arose as a result of operative procedures and 20% were related to medications. Looked at differently, about 2% of all patients in the hospital had an operative complication, somewhat less than 1% had a drug-related adverse event with a total of nearly 4% of all patients having some injury secondary to hospital activities. Another study of errors by Andrews and colleagues, published in the major British journal The Lancet, followed 1047 hospitalized patients on two intensive care units and one surgical floor. Unlike the Harvard study that found about 4% of patents had an adverse event, this group detected 46% overall had some form of adverse event and that 18% of patients had a serious adverse event. They noted that only 23% of adverse events were actually reported up the chain of command. In data from the American Hospital Association, 17 30% of patients had one or more serious events. Convert this to a typical 350-bed community hospital with about 14,000 admissions and 5,400 surgeries and there will be 4000 serious adverse events each year. By rank order in this hypothetical American hospital the following AVERAGE AMERICAN HOSPITAL adverse or unexpected events will 350 Beds 13,600 Admissions 5400 Surgeries occur: 884 patients will have an SERIOUS ADVERSE EVENTS per YEAR adverse drug event, 816 a nosocomial infection (i.e., an infection acquired in DRUG 884 the hospital), 696 a procedural INFECTION 816 complication, 544 an unplanned PROCEDURE COMPLICATON 696 readmission, 408 a decubitus ulcer, 299 ANESTHESIA COMPLICATON 163 will die, 204 will have a fall and 163 TOTAL 4014 will have an anesthesia complication. (Combining the procedural, anesthetic, surgically-related nosocomial infections and the surgically-related medication errors leads to the conclusion that the perioperative environment is the location for the greatest number of adverse events.)
AHA STATISTICS; HCAB ANALYSIS

Whether one accepts the lower numbers or higher numbers as more realistic of the typical hospital, the fact is that there are all too many lapses in patient safety in United States hospitals. Given the available data it is clear that the specific areas to address first in addressing the safety issues are: perioperative events, medication errors and nosocomial infections. Further, in the operating room environment, it is critical to recognize that medication errors and the development of nosocomial infections are major aspects of perioperative patient safety approaches. What is to be done to prevent these types of errors from occurring? The Institute of Medicine in a landmark publication in 1999 wrote that as many as 44,000 to 98,000 Americans die as the result of errors in hospital each year. These are incredible numbers

and many have disputed them. But even if only half or ten percent occur, that is way too many. The IOM report was entitled To Err is Human, a very appros title since that is the basic problem. Humans make mistakes. Humans will continue to make mistakes. Well-educated and well-trained humans will make mistakes. Humans that double check will still make mistakes.

Why Focus on the Perioperative Environment? We know from the studies noted above and others that errors in the perioperative environment are not only frequent but also prone to be serious and with long term consequences. In Current State of the Operating Room todays civilian or military hospital, the OR is at General Mode of Operation Teamwork - fragmented the center of the action, both clinically and Communications - voice and grease boards financially. If the OR suite runs poorly, the entire Much energy - focus on function rather than patient care Surgeon personalities - strong factor in its operation hospital is adversely affected. Operating Rooms Workload - highly variable with high peaks have changed dramatically in recent decades but Complexity - high Time - wasted (Someone in the OR is always looking for the management principles have not developed some critical thing while the patient and surgeon wait) Information systems - limited usage wit h Response to Unplanned Events the se changes. The acuity level and the Unplanned events occur frequently and in complexity of operative procedures are clusters much higher and rising. It is truly a high OR responds - one at a time velocity environment choked down by As unplanned events increase, the OR response becomes more unpredictable and therefore the human inability to mange this level of more stressful complexity and tempo. Surgery has Different people in the OR respond to stress in advanced to the point where humans different ways cannot keep track of all activity. High stress affects patient care as well as employee turnover rate Nevertheless humans are routinely expected to overcome this level of complexity on their own, yet it is simply impossible.
Effect of New Technology/New Procedures
New technology - primarily intraoperative advances, not pre or post operatively or aimed at the infrastructure New technology - evaluated primarily on surgeon satisfaction or time saved New technology - must be very time efficient in order to be utilized under conditions of stress. Otherwise people revert to older learned methods Technology education - on the job, gained by observation and is sporadic dependent upon manpower The balance between patient safety and other factors such as convenience or cost usually not explicitly defined

Improving patient safety will concurrently improve OR efficiency and effectiveness because the change in processes and systems needed to produce improved safety are the same as those needed to improve effectiveness and efficiency. Hence, improving patient safety in the perioperative environment will not only have a value in and of itself, it will improve morale of the staff,

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allow better use of an expensive capital asset and reduce expenditures per case and per day. Safety is often thought to start with education and training, both of which are critical. Although these teach basics, they do not necessarily reduce errors, the errors made by well intentioned and usually well trained individuals. System changes are the key to improved safety. The Table addresses the rank order of power of various Error Reduction Strategies approaches noting that forcing functions (e.g., Highest value requirement that all medication orders be Forcing Functions and Constraints entered only via computer Automation and Computerization with its built in queries on Standardization and Protocols allergy and built in knowledge) are most Checklists and Double Check Systems valuable and education least Rules and Policies important.
Education and Information

Whatever the final Lowest value approaches accepted, it is clear that they will definitely include the engagement of systems, methods and technologies already proven in other industries. They will need to be modified and adjusted to be acceptable and effective in the operative setting but will fundamentally be based on prior knowledge of industrial and management techniques, augmented by advanced technology. Among the latter are: 1) Approaches to positive identification - of patient, staff, equipment, instruments and drugs with appropriate new technologies such as bar coding and RFID. 2) Improved situational awareness using voice and visual technology along with advancements in tactile clues for the surgeon. 3) The electronic medical record and surgical information systems will be essential to integrating the myriad digitized information sources available. 4) Automation will be critical in records management, supply chain management, and sterilization procedures. 4) Further, advanced devices and technologies will allow not only better surgical outcomes but also safer surgery e.g., simulation, robotics, neuronavigation and intraoperative MRI. These are but a few of the keys to improvement. Common to all will be the extensive use of information technology.

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General Concepts About Safety in the Operating Room Of all medical errors about 20%, and probably more, occur in the operating room. The OR is fundamentally different form other elements of the hospital. Foremost is that the patient is asleep or sedated and therefore cannot assist in his or her own mitigation of hospital based errors. In short, the patient needs advocate(s.) Further the OR is a high velocity environment with increasing efforts at productivity enhancement. This velocity increases the opportunity GENERAL CONCEPTS for error. The environment is also 20% MEDICAL ERRORS OCCUR IN increasingly complex, increasing the PERIOPERATIVE ENVIRONMENT opportunity for error and increasing the PATIENT ASLEEP (cannot assist in error need for training and education. mitigation) Interestingly, the team in the OR, HIGH VELOCITY ENVIRONMENT typically the surgeon, anesthiologist HIGH COMPLEXITY ENVIRONMENT and scrub nurse or technician, is really OR TEAM NOT A TRUE TEAM not acting as a true team. They work COMMUNICATION A MAJOR ISSUE together in the same location, sharing workspace, overlapping responsibilities and goals, but each has distinct roles so in some ways they function separately. A critical issue is therefore to improve teamwork if only for the purpose of improving safety. Finally, the operating room is inherently a dangerous location for both patient and staff; the patient because of the potential for error and the latter because of the potential for injury from equipment or instruments. Communication is often noted as not clear, and that there is not clarification that a request/communication was received and understood (i.e., similar to the read back approach in the cockpit or on a naval bridge.) Every anesthiologist will state that putting a patient to sleep is inherently dangerous; a matter of degree of risk for the patient versus the expected benefit or outcome of the procedure. Anesthesiologists often feel they have divided attention problems, i.e., they are checking the records and materials for the next case while giving anesthesia to the current patient. In part this is caused by the eroded preoperative examination [see below.] The anesthiologist, surgeon and nurse/ technician are also relied upon too much to be ever vigilant. There is a growing need for sensors to detect rare but crucial events that can lead to patient harm. Technology in the operating room suite is surprisingly behind the power curve. This is especially true for the electronic medical record and surgical informatics in general. These prove to be major issues as will be discussed later as part of the patient identification issues.

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The OR suite is usually a profit center for most hospitals. As a result there is all too often a reluctance to confront safety issues. Further, since it requires gowning, most hospital executives avoid visiting the OR suite.

Specific Issues for Concern in the Perioperative Environment The specific areas of concern in the operating room, many related to data and communication, are the following. Of major importance, and raised by many who work in the OR suite, is proper patient identification. This implies not only being sure the right patient is in the OR but that the team knows the patients medical issues clearly in addition to knowing the planned site of the operation (left breast, not right) and the procedure planned (lumpectomy with sentinel node removal, not mastectomy with axillary dissection.) Absence of all of the proper data and information about the patient will lead to delays at best and frequently to errors, some serious with adverse consequences, at worst. Operating on the wrong site may not occur often but the stakes are very high. Further, the entire team needs to know what the plan of work is to be so that each can do his or her part effectively. Too often there is inadequate communication among team members on the planned procedure. Patient needs are often exacerbated by incomplete medical records which are rarely electronic, rarely can be rapidly obtained if not present in the OR. The result is that the team makes assumptions based on incomplete data. Medication safety is a high priority just as elsewhere in the hospital but amplified by the fact that the patient is asleep. Patient identification procedures should have indicated if there are any allergies and this must be in written form available to all. A decision to start an antibiotic, for example, must be undertaken with knowledge that the patient is not allergic. Prophylactic antibiotics are a key issue in OR safety. These antibiotics need to be given and given at the start of the procedure, not later, if they are to be efficacious in preventing a post operative infection. The OR is a place where fluids of various types are used to irrigate the site, clean the skin, etc. These fluids need to be labeled. If the scrub technician is called out of the room or is busy with a retractor, it is possible for someone else to assume an unlabelled container to be other that what it is. A very unfortunate accident occurred in a Florida hospital when saline was used to irrigate the operative site. Unbeknownst to the surgeon, the unlabelled container he used was not saline but a combination of lidocaine and epinephrine, leading to the childs death. Infection control is critical in the OR environment. The culture is such that no one would enter the OR without properly scrubbing and gowning but there is less attention often paid to the prophylactic antibiotics or whether the patient is infected or colonized with bacteria resistant to most antibiotics, i.e., needs special attention to avoid cross SPECIFIC ISSUES contamination. Post operative infections are only recognized later on the unit or after PATIENT IDENTIFICATION discharge; not adequately related back to an
MEDICATION ERRORS INFECTION CONTROL INTRAOPERATIAVE ISSUES TRANSPORT AND HAND OFFS COMMUNICATION OR ENVIRONMENT

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event that did or did not occur in the OR. Lax behaviors, perhaps again because the patient is asleep, may be one key to addressing this problem. Finally, emerging infectious diseases may be problematic such as West Nile or Avian flu. Some specifics about infection control include skin preparation. There is good evidence that a clipper is less likely to lead to site infection than a razor but the razor has stood the test of time for most surgeons who are wary of change. Chlorhexidine, which is colorless, as a scrub is better than iodine-based scrubs. If the prep is done by an assistant before the surgeon enters the OR, the surgeon cannot see that the scrub has been done to his or her satisfaction so iodine scrubs are still preferred. Vascular access lines should, based on good studies, be inserted with full sterile prep (gown, mask, gloves and sterile drapes) but this is uncommonly done because the supplies were not readily available or just lax technique but otherwise well trained physicians. Blood sugar elevations enhance infection rates after cardiac surgery among diabetic patients. There are inadequate studies relating blood sugar and infection with other surgical procedures so that glucose levels may not be followed in other than cardiac surgery. There is data that reduced temperature can predispose to wound infection but OR temperatures are often kept cool for staff comfort in the bright lights with heavy gowns. There are a host of critical intraoperative factors to consider. As to anesthesia, there have been substantial improvements over the years especially in drugs, monitoring and preoperative evaluation. But safety is being eroded by the pressures to have faster production and fiscal effectiveness. Further, new technologies if improperly introduced can exacerbate the divided attention noted previously. Anesthiologists might consider utilizing various monitors and sensors to detect unexpected events as a way to maximize their vigilance needs. There is an interesting European study that demonstrates the utility of autopilot technology to aid in anesthesia control and safety. The OR is an inherent hazard zone for the patient with opportunities for electrical, chemical or other injury. Drug reactions, falls, burns, pressure, nerve injury, thrombosis and or blood clots can occur while the patient is asleep. The OR is inherently poorly managed for these issues, not because people dont pay attention but because the OR is complex with major opportunities for error.

The patient must be properly positioned to prevent pressure and hence damage to a nerve or tissue. Since the patient is asleep, he or she cannot tell the team if the position feels wrong. Peroneal nerve damage is uncommon but a real risk in OR setup. If the operating table is not properly set up, in some instances, it can collapse leading to a fall for the asleep patient, obviously a serious risk. Electrical instruments must be properly grounded to prevent sparking and ignition of anesthetic gases. There is an increasing number and variety of devices that deliver energy to patients by one means or another. It has become increasingly difficult for Biomed departments to verify the correct function of these devices because of inherent complexity field testing is often impossible and a simple electrical test may tell little about energy delivery to a patient. Fire safety is more important than most think. There is about one fire in an OR in the USA each week,

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usually due to gases being trapped under drapes and ignited by a device either unwittingly due to cauterization equipment or the spark of a faulty piece of equipment. Lasers are of immeasurable benefit to todays operations but they are inherently dangerous and need to be treated as such. New endomechanical devices that aide the surgeon dramatically, such as staplers and suturing instruments, can misfire. Imagine doing a laparoscopic procedure on the kidney only to have the stapler misfire and penetrate the aorta; it has happened, due to malfunction. Also during the case, there is a need to monitor critical variables. Not only heart rate, blood pressure and respirations but also, for example, blood sugar. During a coronary artery bypass (CABG) case, watching blood sugar on a diabetic will prevent it from rising too high thus increasing the risk for a sternal wound infection after surgery. More and more parameters are being monitored today but monitors often do not integrate with one another (there are no standards for integration.) Coordination among devices is needed as is an ergonomic design to enhance the ability of the team members to see data without neglecting other patient needs. This might include positioning, duplication or heads-up display devices. Imaging is done more and more frequently in the OR and is of major assistance to the surgeon in planning and progressing on the case but with it comes the need for imaging safety. Staff knows to protect themselves with lead lined gowns or to leave the room, but it is also important to remember that the patient is at risk too. Yes, it is just one shot but the eyes, thyroid and reproductive organs need to be shielded nevertheless. Finally, the standard protocols for sponge and needle counts are key. There is nothing worse that having a patient with persistent pain after surgery whose abdominal X-ray shows a retained clamp, missed at the end of the case. Apparently, retained foreign bodies are more common than may be believed. Post operatively, patient transport is a vulnerable time with some areas ripe for fairly frequent error. Not locking the stretcher wheels before transferring the patient to the bed may lead to a patient on the floor, possibly with a broken bone. Similarly, airway management of this patient who is still groggy at best needs to be attended to. Losing the endotracheal tube during transport can be a calamity. Patients are frequently not monitored during the brief trip to the PACU, ironically the highest risk period for the slightly awake patient. Lacking pulse oxygenation monitoring, many if not most patients are placed on nasal oxygen whether needed or not; an expensive work around by staff when the hospital avoids the expense of the monitors, or an over use of a technology needed for only some patients. The post anesthesia care unit (PACU), previously known as the recovery room, has, like the OR, a more rapid pace of care, greater complexity than the past, and often serves as a temporary surgical ICU while the patient awaits a regular ICU bed to open. This requires a new level of expertise and experience by staff along with technology advances to aid in patient observation and care. For example, the introduction of pulse oxygenation monitoring in the PACU has been a major advance in safety.

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There is much opportunity for error in the whole supply chain. As with any complex environment, logistics are critical to functionality. Todays OR is filled with equipment, monitors, instruments, imaging technology and the like. Each case is different and has its own required set of materials. All too often the supplies are incorrect. Perhaps the surgeons preference list was not checked, perhaps there is a broken or bent instrument, or even a critical implant is not available for the case. Most of the time it is possible to improvise or use something slightly different. An aortic graft that is one size greater or smaller than desired is not much of a problem but the wrong size aortic valve is a show stopper. When that happens, in addition to a tense surgeon and a frantic search for the correct item, there is breakdown of teamwork and harmony. Consider this example: a patient is having open heart surgery to replace a valve. At the critical moment it is realized that the valves available for insertion are all the wrong size. No others can be found after a frantic search of the storeroom. Calls go out to other hospitals nearby that do valve surgery (not many.) One has the right size. A nurse takes a cab to that hospital and races back with it while the patient remains on the bypass pump. Finally the case is completed; no one apparently the worse for the experience except that the patient has a much longer time on the bypass pump than should have been necessary with all of the potential complications that extra time engenders. If nothing else, this example shows how trained professionals can be pulled away form their core competencies of patient care. Communication is a critical factor in the OR and better communication is essential to reducing errors. Many interviewees stated that most errors have as their root cause a lapse in communication. Inadequate read back is common and not part of the culture of the OR (as it is in the cockpit or on the naval bridge.) All of the patient identification issues discussed above are really about good communication such as having the right information at the right time in the right place and getting it to all of the right people. There are many hand offs from nurse to nurse, nurse to tech, surgeon to tech, etc. These are information handoffs and are part of the communication problem. Many safety checks are left to the last minute is the consent in the chart and signed? Are the laboratory tests back and acceptable? Is there a prothrombin time report for the patient who has been on anticoagulants? Plus there are issues of complete documentation of more occult problems does the patient have mild pulmonary or cardiac disease that will manifest itself as the result of the stress of surgery and anesthesia? Again it is important to recall that the patient is asleep so he or she can no longer be asked; all the more reason why it is so important to know the patient. The operating room environment creates its own set of potentials to foster errors. The staff is rather insular. Nurses and technicians come to work, put on scrub outfits and remain in the OR suite for the entire day. They eat lunch there, take their breaks there and socialize there without leaving until their shift is over. Since it requires donning scrubs to enter, few personnel from elsewhere in the hospital visit the OR. The staff of the OR is thus less likely to be aware of changes occurring in other units of the hospital and is less likely to embrace change.

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The OR today is very technology driven so the staff must be familiar with many new pieces of equipment. Greater sophistication of equipment means increased cognitive burden on the OR staff and more opportunity for error. The OR today is productivity driven. It is important in todays financial climate that these highly capital intensive suites are maximized and made as efficient as possible. While this can make for safer and more effective care it also means more opportunity for error. Add to this the high velocity, high complexity, tense environment with a strong hierarchy and you have the makings for error generation. Hierarchy or a culture of hierarchy can have an adverse impact on teambuilding and teamwork. But, putting a patient to sleep and operating on them is an awesome responsibility. This said, it is equally important for all team members to recognize the responsibilities of each team member and to understand the ultimate responsibility of the surgeon for the patients welfare. There is obviously a balance between the authority of the surgeon to direct the procedure and the requirement of each team member to effectively voice concerns for the patients benefit. All of this can lead to a tense environment. Sometimes it is exacerbated by inappropriate behavior due to inadequate support systems, supply chain breakdowns, instrument processing glitches, inaccurate scheduling, and changes in the days work schedule at the last minute, technology malfunction or unfamiliarity with the technology in use. ORs are usually profit centers for hospitals. Hospital management is therefore loath to confront surgical behaviors even when it may be detrimental to patient care/ safety. [An example is that of a senior cardiac surgeon who was in solo practice and grossly overworked but unwilling to accept the reduced income consistent with adding a partner. The result was a major increase in the risk of infection for his patients late in the week compared to the first case on Monday morning. Hospital management did not want to confront the issue because of his high productivity but eventually, when a hospital epidemiologist presented specific data, were forced to intervene due to patient safety concerns.] On the other hand, hospital management must also recognize the totality of needs and agendas of the surgeons; those needs are not only related the operating room. Private and academic surgeons have somewhat different agendas. Management must recognize that both have office practices to attend and academic physicians have other pressures from their School of Medicine responsibilities. Hospital management must be responsive to these needs as one element of enhancing patient safety.

Also inherent to the OR environment are some basics related to experience, training and also to alertness. Less experienced surgeons are more likely to make an error. Surgeons using new technology without adequate training are prone to more errors. Inexperience in

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other team members is also an issue such as working with an inexperienced scrub, circulator or anesthetist. Assistants may lose alertness during lengthy cases. There is a need for mechanisms to regain alertness at critical times in the case (ala the B2 bomber pilot who flies from Iowa to Afghanistan and back; needs to be especially alert when on the bombing run over the target site but can and should rest at other times.) Available Data on Patient Safety On first glance it might seem remarkable that, given the potential of error, there is such a paucity of data available on patient safety in the OR setting, but such is the case. This lack of data also inhibits national organizations and individual hospitals from taking a more proactive stance related to safety in the perioperative environment. Instead, most hospital effort has focused on medication errors, nosocomial infection, blood product administration and other areas where data is more easily accessible and for which data is available today. Hospitals have long used incident reports to keep track of problems and issues. They are sent up the chain of command for review and for changing procedures to help prevent such an incident in the future. Of interest, incident reports from the OR tend to focus on equipment failures, instruments missing from the set, supplies not available and occasionally on retained instruments or sponges in the site. Rarely do they address medication errors or technical errors on the part of the anesthesiologist, surgeon or nurse. As a result, the frequency of technical errors or errors related to the majority of issues enumerated above is simply unknown. Twenty years ago the Maryland Hospital Association (MHA) began, with seven participating hospitals, a process of collecting, analyzing and reporting back data on quality indicators. This has grown to now include over 1400 participating hospitals worldwide in a system known as the Quality Indicator Project (QIP) operated for MHA by it subsidiary, the Center for Performance Sciences (CPS.) The indicators (such as unscheduled returns to the emergency room, documented falls, unplanned returns to the OR, etc) were designed to be value free, that is, they are meant to offer guidance as to where an institution might want to place emphasis in addressing quality. So a high or low incidence of Caesarian section is not intrinsically good or bad but rather a marker or comparison with others to offer guidance. Among over 290 acute care measures available to hospitals, certain measures have proven to be especially valuable in addressing not only quality but specifically safety: administration of antibiotic prophylaxis, unscheduled return to the intensive care unit, unplanned returns to the OR, etc. These tend to have a relationship between the care process and a high likelihood of error for which there is a published association. The JCAHO-mandated ORYX core measurement concept allows use of the QIP system as one of its core measurement techniques; it has become the most widely used of all core measures in the country.

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When the University Hospital Consortium (UHC) looked at the literature of OR safety a few years ago it was found to be incredibly data poor. Anesthesia was in the lead in documentation but the emphasis was on the single catastrophic event, ala an aircraft crash or power plant failure. Anesthiologists did do root cause analyses which have led to major improvements in anesthesia care and safety but there was less attention to near miss reporting. There was little or no data from the surgeons and hospitals, overall, did not focus on OR errors. UHC set up a hospital-wide PC to Internet-based error event reporting system. Their initial lessons were that this elective collection of data greatly UNIVERSTIY HOSPITAL CONSORTIUM improved reporting. Hospital department managers would access and use the data PATIENT SAFETY DATA COLLECTION directly in real time rather than waiting for a WEB-BASED, COMPUTER INPUT, EVENT REPORTS monthly or quarterly report to be sent back. STAFF CHOICE TO REPORT Managers and others could also do data 71,000 EVENTS FROM 60 HOSPITALS OVER 2 YEARS mining such as looking for the frequency of 8.7% (6219) FROM PERIOP ENVIRONMENT reported falls. The system does have some DISPORPORTINATE % OF HARM FROM PERIOP EVENTS deficiencies, perhaps the greatest being that UHC DATA: JUNE,2004 those who enter data do so with their own biases as to what constitutes a reportable error. Reporters are not trained observers but they do tend to be enthusiastic. So, it is imperfect but a very usable and useful data base. In late 2004, with over two years of reporting by more than 60 university affiliated hospitals, there were over 70,000 events in the data base of which 6219 (8.7%) were from the OR perioperative environment. The most common OR errors proved to be: errors related to procedures, complications of procedures, equipment issues, medication errors and loss of skin integrity. Further, the Pennsylvania Patient Safety Authority (PSA, www.psa.state.pa.us/psa) has purchased the UHC system via ECRI and has mandated it use to monitor over 420 health care facilities. Its program is now (April, 2005) in its tenth month of operation. The state of Minnesota mandated that all serious errors (based on a predefined set of 27 criteria which in turn were based on a National Quality Forum list of events that Minnesota Adverse Events Report never should occur to a patient in a health State Wide Surgical Events care facility) were to be reported to a central 378,544 Surgeries agency which in turn would make the data 13 Wrong Body Part public. The first report was issued in January 1 Wrong Patient 5 2005and covers 16 months of initial data. Wrong Procedure 31 Foreign Object Combined, all hospitals in Minnesota reported 2 Death 99 events of which 52 or just over one half were surgically related. These included 13 52 TOTAL operations on the wrong body part, one operation on the wrong patent, the wrong procedure preformed on five patients, a foreign body left in 31 patients and 2 unexpected surgically related deaths. The actual incidence was low as these cases, disturbing as they

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are, were drawn from 378,544 surgeries. This is one more instance, however, that serves to emphasize the types of errors that can and do occur in the OR. The major deficiency of the Minnesota program is that near misses are not reported. How often were errors detected and corrected before actual harm occurred? It is from near misses, which are much more common than actual serious events, that trends and implications can be developed with resultant changes in procedures and systems can be implemented. In short, there is much data on quality available hospital-wide including some data on the perioperative environment but relatively little information on the most frequent types of errors, both near misses and errors leading to serious sequalea in the OR and perioperative setting. It is the authors belief, based on interviews, that this scarcity of data is due to two causes: First, most hospital managers do not enter the OR suite because it means gowning up and as a result they avoid the issue of OR safety. Second, there has been little data collected in the perioperative setting by trained observers who can watch for errors of omission and commission, errors of knowledge, training and technique in addition to those that tend to be reported now such as major errors of wrong site or procedure along with instruments not delivered, equipment malfunctions, other supply chain mishaps, etc.

Conceptual Approaches To Developing A Program To Enhance Safety Medication errors, listed as the most common safety concern by the IOM, are a logical first place to begin a program of patient safety in a hospital and indeed most hospitals have started there. It is sort of a lubricant for the whole institution to address the basics of safety. A successful program will address human factors, cultural issues, technologies, a non punitive environment, robots, bar coding, packaging and storage and information technology. All of this can be a means to a more general end of advancing patient safety. Further, medication errors are a major element of all medical errors and so are very important in and of themselves. Obviously, physician input and involvement is essential to a full and completely effective medication safety program but if physician interest cannot be generated early on, there can still be great progress with work by nurses and pharmacists along with medical records staff, clerks and others. The operating room suite is fundamentally different from other areas of the hospital and as a result patient safety must develop in a manner somewhat different from the rest of the hospital agenda. However, the lessons learned from medication safety can be a stepping stone. In the OR, the physicians, both surgeon and anesthiologist, in addition to the nursing staff, are critical to advance the safety agenda and their commitment and support of the work must be achieved before progress can be made. Any substantative research program must enumerate what happens. But it is important to differentiate between numerator and denominators. To say that 16 serious adverse events occurred seems like a big number. But if there were 3000 cases then the incidence of

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errors is quite low. But try to explain that to the one person who was injured, or their relatives or lawyers. The challenge is to separate accurate measurements from a political set of issues. Numerators will make the data look alarming; denominators will make it look less so. The real issue is what is happening and how can it be prevented or significantly reduced. To do this requires accurate monitoring mechanisms, mechanisms that are not present in ORs today. Studying adverse events, fairly uncommon, may not yield great dividends although a root cause analysis of each is important. But evaluating near misses, which are not uncommon, may yield large rewards by demonstrating weaknesses in processes and systems. The changes needed will be the outgrowth of process improvement programs since improvements will depend on the improvement of processes. Consider a box representing all procedures. A small box within the box at the upper left corner represents the cases of errors and a smaller box still inside the second box represents the adverse events resulting form those errors. Some advocate focusing on the adverse events, others on all errors since they are the forerunner of adverse events. Either approach has its advocates but critical is to have a formal measurement system that fully enumerates all errors and all adverse events, something lacking at essentially all hospitals today.

The evaluation of reported errors and adverse events will require getting a team of surgeon, anesthiologist and nurse (minimum disciplines needed; probably will want to add logistics, biomedical, pharmacy, information technology, etc). The team will need an observer dedicated to the program that can observe and collect data on processes and the resultant errors. The observer or another person on the team must be trained and skilled in evaluation and process analysis and redesign so as to assist the team in their planning for corrective actions to change systems. It is essential that all members of the team be involved and be invested. Leadership from the chief of surgery and chief of anesthiology is of obvious importance but to get physicians truly invested and committed requires that the process be data driven. Physicians are all scientists at heart and want to address problems from a scientific perspective. Absent such an approach, the physicians will remain on the sidelines, at best, and will undermine the effort at worst. Hospital managers frequently make the mistake of assuming physicians will not participate or that they always doubt the information presented. It is again essential for hospital managers to make the data available and then be prepared and willing to rework the data or collect additional data to satisfy the medical team members. Once this is done, the medical staff will be responsive and responsible.

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Approaches to Enhancing Patient Safety in the Perioperative Environment A successful approach to improving the safety of the OR and its environment will depend on BASICS developing an environment OR A HIGH RISK AREA of safety and SUGGESTED APPROACHES TO HIGH VELOCITY/ HIGH COMPLEXITY/ on attention HIGH STAKES IMPROVED PATIENT SAFETY OR ERRORS LEAD TO to both DISPORTIONATTELY MORE HARM human CREATE ENVIRONMENT OF SAFETY factors and HUMAN FACTORS TECHNOLOGY FACTORS technology factors. The agenda is to create a high reliability performance organization. Environment of Safety Creating an environment of safety is the first and critical step to an overall program on safety in an institution. This includes building a culture of safety within the institution, having intensive and recurrent training, developing organizational learning and creating optimized structures and procedures. There is much about patient safety in the OR that can be migrated from other programs in the hospital. But most of what happens in the OR is simply different from the rest of the hospital and thus needs its own agenda and focus. The closest contemporaries are the other high hazard areas such as ICUs, so to the extent that safety work is proceeding there, it can be transplanted to the OR. This requires commitment and buy in from the top of the organization, notably the Board, CEO and executive management. Absent this and no program on safety will flourish because of the cultural changes that need to occur and the commitment of resources that are necessary. It is a simple fact of life that most hospitals, like most American institutions, operate in a punitive style. Staff members are expected to be careful and not make mistakes. Those who do make mistakes must be identified and punished; they must accept accountability. In our litigation prone society, hospital risk management departments and lawyers will advise professionals not to admit to errors to patients or family, nor even to offer apologies as that may be considered tantamount to admission of guilt in a malpractice case to come later. Although understandable, these are essentially opposite to what is needed for of an effective approach to reduce errors.

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Humans make mistakes; this is a deficiency that we all have and always will have no matter how well educated or trained we are. To Err is Human was the title of the initial Institute of Medicine report for a reason - it is simply the fact. Given this fact, we need to develop appropriate methods to deal with this natural human tendency. Without question, chastisement, CREATING AN ENVIRONMENT OF punishment, and the like are counter SAFETY productive; this just leads to Obtain Top Down Commitment underreporting of errors and near Commit to Required Investments misses since no normal individual will Create a Non Punitive Environment Ensure Disclosure of Unanticipated Outcomes to want to subject themselves to Patient punishment. The key is to develop a Improved Reporting non punitive environment where it is Use Process Improvement Approach Create Paths of Least Resistance considered the norm to report error and Collaborate with Human Factors Specialists near misses, either directly or anonymously. It is important to note that non punitive does not imply non accountable. We must all be accountable for our actions. A patient or his family must be compensated if harm befalls him. But the patient deserves to be told of the error, whether harm occurred or not, and the institution needs to know of the error and be capable of responding to it effectively. Errors that lead to patient harm need to be recognized and reported. Equally important is to recognize near misses, those errors that were caught in time but which, if left unattended, could have led to harm. Most hospitals do not have an active system in place to capture error and near miss reports. In a nonpunitive environment it becomes feasible to institute an error reporting system and assume that with time staff will embrace it. Reports need to be fed into a data base that is regularly analyzed to determine frequency of error types, patterns of errors, etc. Critical to staff involvement is to get feedback regularly and to act on findings. A systematized process for reviewing errors needs to include root cause analyses or what factors were present that: - encouraged the error to occur (e.g., short staffing, complex environment) - prevented early error recognition (lack of monitors/alarms) - did not actively function to prevent error (non functioning alarms) Unsafe practices occur because a process works for a person; asking them to change is essentially impossible. People will always gravitate to the lowest energy approach. Rather than try to change the person, instead it is critical change the environment so that a safe practice results. Changing the environment often requires resources. The safe path must be the only path available, if so, it will be the path followed. The needed resource may be a wall, a new technology, or tracking the patient in a new manner such as RFID. Here are a few examples of creating such a pathway: Computer Physician Order Entry (CPOE) at the Massachusetts General Hospital (MGH) requires the physician to use the

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computer to order a medication; it is impossible to order a drug without using the computer system. Further, the system will not accept an order until the allergy fields have been completed. The result is that the physician uses the advantages of the computer with its allergy checking function. Another example, also from MGH, is a new anesthesia billing system which forced real time documentation by the staff anesthiologists. This led not only to the better collections for which it was installed but also to much better documentation with improved safety and a significant reduction in errors. The institution must commit to the process improvement approach and commit to a standardized approach to reporting and analysis of error and near misses. Examples of systems available are those of the Center for Performance Sciences Quality Indicator Project (QIP) and the University HealthSystem Consortium Error Reporting System. The QIP was initiated twenty years ago for the benefit of Maryland hospitals but now serves over 4000 hospitals across the country and many overseas. Hospital quality staff input specific outcome data which is assembled at CPS, analyzed and compared to local and national norms. Indicators include frequency of Cesarean sections, unexpected return to the OR, ICU or Emergency Room, death following cardiac surgery, etc. Each institution can choose the indicators it wants to utilize. Certain indicators are satisfactory for the JCAHO Oryx requirements. The advantages of the QIP are that trained individuals enter data; the disadvantage is that they do so based on chart review rather than real time observations. The data are submitted in batch to CPS and results are tallied on a quarterly schedule. The University HealthSystem Consortium program was initiated a few years ago to benefit its membership of over 100 university affiliated hospitals. The system uses any computer with internet access to submit an individual report of an error. Any staff member (physician, nurse, etc.) with a password can submit a report, usually in real time or shortly after an incident occurs. The system queries the submitter for information as to the nature of the incident, the location, some patient demographics, whether and what harm may have occurred and what the causative factors might have been. The advantages are that an incident can be reported in essentially real time by the individuals involved or who witnessed the incident. The local manager can access their institutions data any time and compare to the current averages for all participating hospitals. The disadvantage is that reporting is neither mandatory nor done by trained observers. Thus the results are dependent on the willingness of staff to self report errors as they occur. Human Factors and Patient Safety

Human factors include leadership, management, teamwork, and the creation of a culture of safety. Any program of patient safety must start with leadership. There is a need for a surgeon, anesthiologist and nurse leader to create the vision, inspire all to a higher level and to establish ground rules for work and behavior. But while leadership from anesthesia and

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nursing is essential, it is not sufficient. There must be a dedicated surgical leader. Often this is the chief of surgery or at minimum a senior associate who has the imprimatur of the chief. In short, success must emanate from the top of the surgical staff. A surgical leader of the suite is critical to ensure functionality. The surgeon needs equivalent leaders in anesthiology and nursing to advance the agenda across all three disciplines. The leader in turn needs to obtain broad consensus of all surgical chiefs / disciplines plus anesthesia, and nursing leaders. The concept is that if the surgical leader clearly spells out a vision the nurse manager can then organize to accomplish it. The surgical leader and his/her anesthiologist and nursing colleagues can then drive the process. The surgical leader needs leadership skills, visioning ability and standing to be effective. The surgical leader must be a champion of specific activities such as: o JCAHO Universal Protocol (time out) o No patient in OR without site marked by surgeon in advance o Appropriate / equitable allocation of block time o Appropriate behaviors (Asleep patients foster opportunity for less than ideal behaviors) The surgical leader with the help of anesthiologist and nurse leaders must assemble a team of engaged, incentivized (not necessarily with money) staff and physicians. Engaged and energized people must be the initial part of the solution. The leader must interact with all levels of the team; this is no place to be focused on hierarchy. (There is a story about the cardiac surgeon, Dr Michael DeBakey, which illustrates the leaders concept of teams and teamwork A reporter wanted to interview the famous surgeon. DeBakey would only make himself available at 6am but gave a 30 minute pleasant, engaged interview. At 6:30 he left his office with the reporter and, saying goodbye, turned and walked down the hall to the OR suite, stopping along the way to talk to a housekeeper who was mopping the hall. They talked animatedly for about three minutes. The reporter, watching from a distance, was fascinated that the great man would talk to a janitor. After DeBakey went into the OR Suite, the reporter went up to the housekeeper and asked what their conversation had been about. Me and Dr DeBakey, we take care of the patients, he answered. Obviously, Dr DeBakey understood the importance of small gestures to keep the entire team focused on the true agenda of patient care.) The leader must set the tone that all of the needed data on each patient must be present in order to start the case. There needs to be no surprises (except those discovered during the operation that no amount of currently available data could have foretold.) Clear leadership will set the tone for the big picture and will get passionate people involved in resolving problems. The leader must establish a culture of caring. Staff will quickly recognize when this is the most basic mission, and will respond accordingly.

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The effective leader will, indeed must, disrupt the hierarchical culture of the OR. This requires a strong champion with standing in the OR community. The cockpit example may help him/her sway colleagues. (For years, the cockpit was the height of hierarchy. The captain was the boss and the copilot and navigator accepted the captains experience and position; challenging the captains decisions was rare, at best. But studies showed that many airline accidents were the result of errors that someone else in the cockpit realized but did not communicate. Over time this culture has changed so that challenge is not only tolerated but expected with resultant much improved airline safety.) To change the culture, the leader must temper those with strong personalities that can become abusive and or prevent other team members such as nurses, technicians or residents from speaking up with safety concerns. Management is different from leadership and equally critical if a patient safety agenda is to be effective. While leadership is about creating a vision, getting others to buy into the vision and ultimately engaging everyone to participate in achieving the vision, management is about putting the vision into action. Management focuses on planning, staffing, organizing, actions and accountability. All too often, there is no clear management in the OR. Who is explicitly in charge? Generally, the chief of surgery is not interested in fulfilling a management role nor is he or she trained in management principles. It usually falls upon the Director of Perioperative Services, who may or may not have true experience and training in management. Clarity about management roles is critical to OR functionality and to a program of patient safety. HUMAN FACTORS Hospital managers need to overcome the tendency to not visit the OR suite because of the need to gown up. The OR is too important and too vital to ignore or manage from afar. Hospital management must also recognize the value of the OR and hence the value of physicians and physicians time. If materials (e.g., sterile drapes for IV insertion) are readily available, physicians will use them. If not available, the physician will be frustrated and will move on with a less safe approach. In short, if safety is to occur, it must be easy to accomplish.
LEADERSHIP MANAGEMENT TEAMWORK INFORMATION TRANSFER TRAINING MANDATES (e.g., JCAHO)

It is advantageous to have a surgeon use the same OR regularly and work with the same team members. This may be less efficient for the hospital but it is far better for safety. To summarize OR management, with clearly defined surgical leadership and a clearly committed hospital senior management, it becomes possible for the senior nurse to effectively manage the day to day operations of the operating suite.

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Teamwork is likewise critical to patient safety yet a true team does not exist in most ORs. Rather there are three disciplines working together for a common good but not really working like a team. They need to become a team; this requires specific training and culture development. One approach may be to utilize the specifics that have been developed in team-creating (e.g., HPTI) such as using the baseline safety aptitude test and then working on the demonstrated deficiencies. There is a need to establish the concept that anyone (not just the surgeon) can call a stop (ala the Japanese auto industry when anyone on the line can pull the stop cord if he has a concern) if one believes something is amiss (or, ala the aircraft carrier where a flight deck junior person can call off a landing if he feels it is unsafe.) Miller writes (The Making of A Surgeon in the 21st Century,2004) that he learned when the scrub nurse handed him an instrument that he had not asked for, the proper response was not to yell but to figure out why she did so because most of the time she was correct and he had missed something. It is imperative that those who work outside the OR but are critical to OR functionality (supply chain, biomedical, environmental systems, information technology) have a true understanding of their essential role and how the OR is fundamentally different form the rest of the hospitals activities. Recognizing that these staff members rarely enter the OR suite, one first approach in this regard is to be sure they gown up and tour the OR on a regular basis. The personality mix of the many OR participants may appear difficult to deal with but this should not be ignored or fought, as is often the case. It is important to recognize the surgical personality and to embrace its positive qualities. The surgeon needs to be decisive and perhaps is more than a little egotistical but then the surgeon accepts an awesome responsibility in putting a patient on the table and operating upon them. Hence safety approaches should not attempt to change the surgical personality but to find ways to maximize his or her knowledge and expertise.

Perhaps an analogy to an orchestra is appropriate. All play different instruments but follow the same sheet of music and play in harmony. For the orchestra to be effective there is the need for a team, teamwork and communication. And there is the need for equivalent (high) skill level for each participant.

Leadership, management and teams all need an environment of safety to be effective, and vice versa. The hospital may have already make progress on the culture of safety through other activities such as a medication error program. But recall that the OR is fundamentally different than the rest of the hospital. On a regular unit, a physician writes an order which the nurse can followup at a later time. In the OR, the team must work

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together concurrently. This requires a different level of teamwork throughout. In part, this emphasizes why it is better to have consistency of team membership so assure better communication and greater safety. Creating an environment of safety requires a champion, generally the surgeon leader. But all disciplines must buy in. All too often, various disciplines have a long standing culture that professionals do not make mistakes; and when they do, they should be punished. Punishment may mean being sent to a training program, notation in a personnel record, or even reporting up to a licensing board. As long as this attitude prevails, any attempt to collect data on errors, no matter how many promises of anonymity are given, is fraught with failure. Read Back is a simple but effective means of reducing error. In the cockpit one crew member announces a setting to be made or an instrument reading; another crew member reads it back to validate agreement before proceeding to the next steps of preparation. In the Navy, the Line Officer on the bridge may command left 5 degrees. The Helmsman responds with left 5 degrees to indicate that he heard properly and the Line Officer then approves with Aye, aye. Once the new setting has been actually made the Helmsman cries out we are left 5 degrees. This constant read back is considered normal yet essential routine in the cockpit or the bridge; it needs to become so in the OR where it is definitely not the culture today. Near Miss and Error Reports are done anonymously by pilots to the Federal Aviation Administration. The FAA collates the information looking for patterns. If a type of error shows up consistently, a new system is considered to help detect the error or eliminate the opportunity for its occurrence. Key to the effectiveness of this program is confidentially. In another country a similar system was introduced only to have confidentiality breeched. Pilots immediately stopped submitting data on near misses and no amount of persuasion could get them to reconsider. But in the USA it has been an excellent program with a long history of positive results. A similar system is needed in all ORs and should be considered institutional learning, not just counting errors.

Variation Reduction is the touchstone of the Deming concept for quality management. The Operating Room however has immense variations and a staff, particularly surgeons, that actively avoid standardization. Agreeing to a common set of instruments or implants by all surgeons doing the same procedure is an act of reducing variation; this needs to be emphasized not as a cost reduction measure (which it is) but for improving quality and enhancing the safety of the surgeons individual patient.

Information transfer is critical to safety. The airline cockpit changes that have occurred over the past fifteen years can serve as a good model of the changes that are needed in medicine in general and the OR in particular. Completing a thorough checklist to ensure that the aircraft is ready for flight became the norm in the 1930s and read back has long been the standard operating approach yet errors continued to occur, some with fatal

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consequences. For years, no one felt empowered to challenge the decisions of the captain; he after all was more senior and more experienced. (The junior copilot or navigator also did not want to risk humiliation nor an adverse report by the captain regarding promotion.) But close evaluation demonstrated that many accidents could have been averted if the copilot or navigator had spoken up when an error was perceived. Changing this attitude in the cockpit so that the copilot feels empowered to question the captain has lead to a much safer airline industry. As with the cockpit, everyone in the OR needs to feel empowered to speak up. Often activities out of line of sight of the surgeon are unknown to the surgeon and so must be voiced by other team members. Similarly, in laparoscopic surgery, all team members can see the same monitor; but the nurse and anesthiologist may see different elements on the monitor and need to report them to the surgeon. The absence of critical/key information can be improved with technology or modifications to current technology (see below.) Training of staff, all staff, is essential to patient safety programs. The case can be made that more registered nurses are needed in the OR. However, many if not most nursing schools have long since stopped teaching OR nursing; a sort of negative recognition of nursings role in the OR. The result is that the average age of OR nurses is now about 48 years and rising. The response has been to develop surgical scrub tech positions. These are well trained and invaluable individuals but they are not invested with the fuller background and education of the registered nurse. Surgical and anesthiology residents need to be trained in order to take their place as the next generation of health care providers. But it is time for a change in the system. Not just assurance that the resident has had some sleep but also that he or she is prepared to be in the OR. The OR leadership team needs to prescribe that the attending surgeon and anesthiologist must be in the room at all times, not just for the critical elements of the case. It should no longer be acceptable to honor the adage that a resident makes the case take longer. The resident needs to be trained and be ready to assume his or her proper role in the case from the start. A good way to begin is to emphasize the use of simulators (below.) Surveys have proven useful to understand the staff concerns about a specific environment such as the operating room. Asking Would you feel it safe for your loved one to have surgery here? gets to the root perception by staff of an institution. The question, What is the likely next thing we will do the hurt a patient? opens a window on staff perceptions about specific patient safety concerns in a unit such as the OR. Mandates are arguably the stick that has propelled patient safety agendas in Americas hospitals. The JCAHO and other regulatory bodies will need to be increasingly clear and directive about the specifics of OR and Perioperative safety. The JCAHO mandate, effective July 1, 2004, to have the surgical team discuss the patient (identification),

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procedure and site immediately before initiating surgery has forced at least some dialogue when often none occurred before. Technology Factors and Patient Safety Technology factors can and will have a major impact in reducing errors in the OR. However, technologies can become a burden and even lead to more errors if the basics (environment of safety and human factors) are not addressed first. The OR needs an active culture of safety and must have leadership and basic management operational systems in place to which technology can then be a very valuable overlay. There is a revolution in medicine occurring as a result of digital technology. The conversion of information into digitized form has the opportunity for major advances in patient safety. Consider the digitized total body scan that today can present the physician with remarkably clear anatomic data, including in three dimensions. Soon that scan will include physiologic and possibly even genomic data as well. Efforts at patient safety must recognize and embrace these advances. As an introduction to the power of technology consider that a new device will allow infra red light to detect veins followed by exact insertion of needle or catheter without puncturing the far wall of the vein. This technique will assist the anesthiologist and benefit the patient. Similarly, control of pain with automatically released anesthetics using carbon nanomaterials can give prolonged duration of relief yet reduced cardiovascular and central nervous system toxicity. Even videogames have proven too be valuable to the surgeon! Warming up before surgery with some of the common video games leads to increased skill levels during surgery (sort of like warming up on the golf driving range before a match.) The residents that regularly play video games have been found to make about one third less errors and complete tasks about 25% faster on a standardized surgical skills test with a simulator. Specific Technologies A good place to start with technology assists is in patient identification and all that the term entails and encompasses. This term is used to cover all of the information about the patient that is necessary to complete TECHNOLOGY APPROACHES the surgery in a safe, efficient manner. TO OR SAFETY Thus includes the patients identify, planned procedure, site of procedure, ELECTRONIC MEDICAL RECORD patients medical history with allergies SURGICAL/ OR INFORMATION SYSTEM and other important medical information VIDEO such as cardiac, pulmonary or renal IDENTIFICATION DEVICES Bar-coding and RFID disease and medication history. It also SIMULATORS includes the results of the preoperative ROBOTICS evaluation by surgeon and anesthiologist,

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including laboratory studies and consent forms. Further it includes the surgeons preference list for the specific procedure, including instruments and equipment needed. This list becomes more or less complex depending on the patient and the type of surgery. The otherwise healthy patient having a minor lipoma removal needs less evaluation than an elderly ill individual undergoing a Whipple procedure. The data collection process must recognize these differences and push the data into the system rather than waiting for a person to pull it in. Patient identification must begin at the surgeons office and be followed up at admission. It must include the patients medical record number and hospital number (if different.) Bar coding or RFID technologies can positively identify not only the patient but everything that comes in contact with the patient including the surgeon, anesthiologist, scrub tech, instruments, equipment, and supplies and medications. ID technologies can be used to help assure the proper site and side is chosen for surgery; that the procedure is as planned , that the drugs are for this patient, that the consent has been signed and recorded, that allergies are accounted for, and that medical problems (e.g., cardiac and pulmonary) that are known are actually known in the OR. RFID technology coupled to wireless technology could establish where a patient is located, which patient is in the OR, and collate the patient ID to the patients procedure, site, required instruments and equipment. The electronic medical record should be accessed with RFID/wireless such that all medical data are available, including that collected at the surgeons office visit, the anesthiologists preoperative evaluation, PREP center data collection plus all images, lab data, etc. It should also be able to access important historical information such as difficulty with prior intubation or prior anesthesia.

The electronic medical record (EMR) will become standard over the years to come. Medicine has lagged other industries in adapting digital record keeping albeit that the medical record is more complex then, say, banking. Much data is directly generated digitally today, e.g., imaging with CAT or MRI scans, results of many laboratory tests, and some transcribed dictations. Other data such as that from monitors must often be hand entered into the medical records, either in written or digital format. Most notably, health care professional notes are usually still maintained in a handwritten format. But this is changing and within a few years most if not all medical data will be digital. Younger physicians may become users more readily than more senior attending surgeons and anesthiologists but routine use by the nursing staff is often the best role model for physicians. Physicians need one-on-one training in use of the EMR, over time with lots of repeats. Time will make or force a change but critical to success is intensive, one-on-one training and continued support until the professional is comfortable with the new system. We are approaching a new age in the availability of the EMR. But it is also the opportunity to convert from the passive (i.e., recording what has happened) medical record of the past to an active record. In other words, the opportunity exists to use the digitized data for processes such as surgical simulation, modeling or instructions to robotic assistants.

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Further, the EMR can hold baseline data of a much greater utility than the long established History and Physical Examination. A total body scan, especially as they are continuously improving, for example, serves as a unique baseline prior to the development of cancer or heart disease or prior to trauma. Finally, the EMR must be readily accessible at all times and in all places. Ideally, each persons EMR should be in their procession (ala the Armys Personal Information Carrier or PIC) or available with a proper password from all sources via the Internet. For practical purposes in the Perioperative setting, one needs to be able to access all of the patients data, in a digitized form, from any source (surgeons office note, preop evaluation record, radiology department, etc.) on demand in the OR, PACU or elsewhere. Such ability will have an immediate salutary impact on patient safety.

Key to effectiveness in the OR or perioperative environment overall is information; information about the patient, the instruments, the equipment and the staff. All of this information needs to be present, coordinated and prioritized. Surgical SURGICAL INFORMATION information systems should be a SYSTEM significant help in aiding patient safety. Some of the key elements that ELEMENTS PRINCIPLES will be needed in todays systems are ELECTRONIC MEDICAL ALL INTERCONNECTED RECORD integration, intelligence, update WIRELESS SURGICAL / OR EASE OF USE ability and prompts. The medical SYSTEM AVAILABLE ANESTHESIA SYSTEM record must be integrated, meaning EVERYWHERE SUPPLY CHAIN ALERTS AND PROMPTS that the entire patientrelevant material SYSTEM KNOWLEDGE PACS INCLUDED must be available, by anyone, at any SURVEILLANCE time. Preferably the record will be INCLUDED electronic, but this is a second step after addressing the issue of integration. The system will be particularly useful if it is intelligent with a system that allows manipulation of data to assist with the surgical task at hand. The DOD smart card (personal information carrier) may be the prototype of this function. The surgical information system must have the capability of storing the specific plan of care for this specific patient with the surgeons preferences for equipment, instruments, even choice of music in the OR. The system needs to be able to be updated by any (authorized) person, at any time, from any location. It should store and manipulate patient protocols for the care plan based on the patients specific procedure. As any deviations occur (and they will!) there must be a mechanism to alert staff and allow for an update to the plan. Built in prompts to alert the staff to do something (give a prophylactic antibiotic) or to watch for something (blood sugar) will improve staff performance. Finally, the system should be able to prompt the leadership as to whether the surgeon is credentialed to use a device (e.g., laser) or the scrub tech is familiar and has experience with the device to be used today in this specific case.

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The Surgical Information System needs to integrate with the EMR. Surgical information systems, in general, tend to have been created to assist the needs of hospital management with the surgeon, anesthiologist and nurse needs being secondary. As a result, professional staff often reject or rebel that the installed system does not serve their immediate clinical needs such as documentation and information presentation. Commercial vendors will need to address these deficiencies. Further, the professional staff need help to avoid data overload. The system needs to prioritize so that all the data needed to make a decision is available but other extraneous data is segregated away. A related technology is for operative note/ documentation of the case. The current approach is to dictate a note following the case but a better approach is to have voice activation or pedal activation of the dictation system so that the surgeon can do the note as the case progresses. Just as computer physician order entry is entering the general hospital, so must it enter the OR for medication ordering, monitoring and recording. The situation in the OR is somewhat different, but even more critical, since the anesthiologist serves as the prescriber, preparer (usually a pharmacist elsewhere in the hospital) and administrator (usually a nurse elsewhere) of drugs. So the anesthiologist needs added assistance since he or she does not have the other professionals involved as a form of check and balance There are other technologies associated with the surgical information system that can improve patient safety. Among these are: Measurement of the pH of the air emanating from the endotracheal tube (yellow or purple) to give an indication of carbon dioxide levels. Intraoperative gas analysis of oxygen, nitrous oxide or volatile gases. Automated blood pressure cuffs that relieves the anesthiologist of a task and frees up time for attention to the patient. Monitors with alarms, provided they can be integrated and ergonomically positioned, should be created for detecting pressure on the patients limbs or nerves or for detecting electrical current leaks that could harm the patient. Alerts can come to the OR professional in many ways. One is an alert built into the surgical information system indicating that a particular patient is a risk, for example, of deep-vein thrombosis. The alert is based on a predetermined review of all risk factors and the system then offers advice on dealing with the potential issue. Such systems need to require that the physician respond to the alert (he or she can decline to act but must indicate awareness of the alert.)

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A picture is worth a thousand words. Video technologies can be useful in a variety of ways. A camera in the light source allows the anesthiologist and scrub tech/nurse a much improved view of what is going on in the operative site; as a result they can be of more assistance. A surgeon can call a colleague to look in on a difficult case without the need of traveling to the OR and scrubbing in. Video of the OR itself can assist the medical and nursing management team to best utilize the ORs in a suite, i.e., command and control. Similarly, a video white board allows all those in the area to get a quick take on VIDEO what is happening in any OR. Video information on the condition of a patient in ROOM CAMERAS the PACU or ICU can be sent in reverse to SUITE COMMAND AND CONTROL LIGHT SOURCE CAMERAS a surgeon or anesthiologist in the OR who TRAIN, TEACH, RECORD DATA recently operated upon that patient and SCOPE CAMERAS who now has a problem. Video is much TRAIN, TEACH, RECORD DATA COMBINED better than just a phone call with a verbal TELECONSULT/ TELEMEDICNE/ SAFETY REVIEW report. Finally, video will augment the PACU/ ICU CAMERAS training of residents and medical students ELECTRONIC MONITORING AND CARE as it will allow them to be in a distant conference room with an instructor rather than in the third row in the OR where they cannot see what is happening well. Finally, video records of the entire case incorporated with the electronic medical record and the voice activated dictation will allow for in depth evaluation of a case after the procedure is completed. This will allow for teaching specific issues or techniques and for root cause analysis of errors or near misses. By analogy, every Monday, each NFL team critically studies the videos of yesterdays game to detect errors and plan improvements. There is a good precedent for distant monitoring by video of patients in the ICU setting. The founders of VISICU, Johns Hopkins faculty, demonstrated that distant video monitoring by an attending intensivist of a medical/surgical intensive care unit at an academic medical center with in house resident coverage led to significantly improved care, fewer errors and reduced length of stay. This technology allows the senior physician to monitor multiple ICUs at one time. In short, it multiplies the physician capability. For the future, robotics will further extend these capabilities. Bar code and RFID technologies will have a major impact on the supply chain. This will be a revolution in the OR just as it is in Wal Mart. Now there will be the ability to locate equipment, instruments, and devices no matter where they may have gotten within the hospital. Further RFID on patients and staff will mean that the patients whereabouts with be known as will that of doctor and staff.

IDENTIFICATION DEVICES
DEVICES
BARCODE RADIOFREQUENCY

USES
TRACK EQUIPMENT, INSTRUMENTS AND SUPPLIES ID PATIENT (& SITE,
PROCEDURE, REQUIREMENTS)

TRACK STAFF RECORD, DOCUMENT, BILL, ORDER AS USED

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Education and training can make good use of technology. Simulation devices can help not only with specific task training but also with team training. The time is fast approaching when a surgeon will review the planned case on a simulator before surgery on a particular patient. The surgeon or trainee can practice the key portions of the operation with patient specific data built into the simulator so that it becomes practice for Mrs. Jones cholecystecomy rather than general cholecystectomy practice. Certainly, the resident should be trained on the simulator until he or she has demonstrated competence sufficient to take the step into the OR. The OR should no longer be the place to learn the basics; these should be mastered on a simulator. Surgeons, like everyone, develop a perception of issues and also of errors. Simulator training can overcome these psychological perceptions and help the trainee to recognize the needed change in approach. Simulators are still in their infancy relative to, say, the airline industry but various models are available and can be put to immediate use. Use will beget more use and more use will drive insistence on routine use. Hospital management will need to recognize the critical importance of simulation and fund the simulation laboratory appropriately. Simulators can greatly assist with team building. It can enable a group to learn how to respond as a team to various situations that might occur in the OR or following surgery. Dr David Gaba has pioneered the use of simulation to teach team crisis response during surgical situations. This mirrors the use of aircraft simulators that test the cockpit crews reaction to various virtual emergencies. Training in surgery is less to develop expertise as it is to develop adequacy. A few surgeons will become true experts at a few procedures given their interest and repeated efforts. But most important is to assure that every surgeon is adequate at every procedure for which he is credentialed. Good training allows the surgeon to know his weaknesses and overcome them; to know when there is a problem and how to overcome it. Simulation has great SIMULATORS potential to assist a surgeon become TRAINING adequate at each task by allowing PROCEDURE practice on patient-specific parameters USE OF TECHNOLOGY/ EQUIPMENT built into the simulator from registering PREPLAN BEST PROCEDURE & the patients digitized images, etc. This, APPROACH FOR INDIV PATIENT REHEARSE PLANNED SURGERY then, graduates to specific practice for a TEAM TRAINING specific patient from general practice on CONTINGENCY TRAINING an average patients data in the CRISIS INTERVENTION simulator. Simulators can allow a concentrated, repetitive experience because the student need not do all of the peripheral (yet vital with a real patient) work needed to prepare a real patient. He can get immediately to the portion of the procedure for which he needs

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practice/training/evaluation/feedback. In a team setting he can be lulled by conversation about a sports event, etc. while quietly and unnoticed the blood pressure is falling due to undetected blood loss. For simulator training to be successful it must be accompanied with a proscribed curriculum that includes milestones of learning and measures of improvement. These become the incentives for a surgeon or trainee to use the simulator it offers value. The opportunities for simulation and simulators to enhance patient safety in the OR are thus legion. The problem is that today, only a few hospitals have any semblance of a simulator laboratory. This will need to change and hospitals will need to allocate the needed resources. A key role of TATRC will be to create the momentum for simulation requirements and outline the infrastructure required to be successful. Robotics- Surgery began to change dramatically with the introduction of the laparoscope about fifteen years ago. This created a disconnection between the surgeon and the tissue and introduced digitized images which could be fed to computers. More recently has been the introduction of robotics to the OR. Todays surgical robots use industry robotic technology to create surgical assistants which are under the complete control of the surgeon via computerized visualization and direction. Other robots are under development as replacements or assistants to ROBOTICS the scrub nurse or technician and still others to serve as implementers of the supply chain for INTEGRATE PATIENT SPECIFIC DATA drugs, instruments or supplies. It is not far LESS INVASIVE SURGERY fetched to predict that there will soon be a (e.g., CABG) merging of digitized anatomic imaging (CT, MORE ACCURATE SURGERY (e.g., Craniotomy) MRI, PET, ultrasound, etc) with simulation by PREPLANNED AND REHEARSED the surgeon to establish the most appropriate SURGERY approach to surgery for a specific patient with BUILT-IN ALERTS AND DETECTORS a specific problem. This will then be followed by transferring the precise surgical plan for this patient to the surgical robot for the patients operation. The opportunities for patient safety are obvious a surgical plan developed with the patients own anatomy as the driver.; a practice run on the simulator to perfect the best approach, and then the precision of the robot in the delivery of surgery all the while under the surgeons control. Similarly, the robotic scrub tech will not miscount instruments at the end of the case and the logistics robots will deliver the precise medications, instruments and supplies needed for this specific case. Safety Programs of Major Organizations A survey of many organizations otherwise involved with patient safety indicates that relatively little is being done with regard to OR or Perioperative safety compared to safety issues elsewhere in the hospital. The author believes that this is largely related to the paucity of data available on the perioperative setting, the fact that the OR is insular (no one goes there except those who work there because of the need to gown, etc), and

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the fact that no one has written much about the subject to generate interest or alarm as has been done with, say, medication errors. Further, there is limited integrated work; each is a separate project without being overtly part of a whole. That said, a number of organizations have extensive programs in OR related safety. Unfortunately, since the various organizations are independent, there has been limited interorganizational activity or planning. Just a few of the many organizations with safety programs are mentioned below: Joint Commission on Accreditation of Healthcare Organizations (JCAHO) JCAHO has a very active program related to patient safety. Its mandates are to a large degree credited with getting hospitals focused on the issues of patient safety. Absent these mandates it is questionable how much real effort would have been devoted to patient safety in the past few years. On July 1, 2004, JCAHO mandated a new universal protocol generally known as the time out. In this protocol, before the operation actually begins, there is to be a pause, lead by the surgeon, in which the surgeon, the anesthiologist and the scrub tech or nurse all agree on the patient, the site of the surgery and the plan of the surgery. All must agree before the case proceeds. This is a major step; again a mandate that must be followed by all in order to maintain hospital accreditation. Surgeons, anesthiologists and nurses generally approve of this step and have rallied to its usefulness. Thus far, this is the only major new mandate from the JCAHO related to OR or Perioperative patient safety. That said JCAHO has multiple long standing protocols related to monitoring patients in the PACU, monitoring patients after conscious sedation no matter where it occurs in the hospital, etc. Indeed, over 50% of JCAHO standards are directly related to patient safety, e.g., medication usage, infection control restraints to name but a few. JCAHO is committed to improving patient safety and uses its accreditation process as a lever to achieve that goal. JCAHO believes there are five key elements: - identify error - root cause analysis of errors - compile data on error frequency and root causes (a critical step in order to set priorities - disseminate this information with intent that organizations will change their systems - access effectiveness of new processes on a regular basis JCAHOs National Patient Safety Goals were promulgated in 2004 and include: ensuring the identification of patients, improving communication, enhancing the safety of medications and infusion pumps, reducing the risk of infection and preventing patient falls. JCAHO Sentinel Event policy Each accredited organization is expected to detect sentinel events (those that actually or potentially cause serious harm to a patient,)

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complete a root cause analysis and report to the Commission. JCAHO collates information and reports regularly to all hospitals lessons learned, such as avoiding high concentrations of potassium chloride in patient care areas. Association of Operating Room Nurses (AORN) AORN has many projects and programs related to patient safety. There are some joint programs with the American College of Surgeons being considered. American College of Surgeons (ACS) The College supports the JCAHO efforts, has published books on safety, and has a number of committees and task forces dedicated to safety. Further, it has spearheaded the study of surgical outcomes as related to preoperative parameters, the National Surgical Quality Improvement Program (NSQIP). Anesthesia Patient Safety Foundation (APSF) Anesthiologists have focused on safety for many years and, as a result, have brought down anesthesia mortality rates dramatically. As a result, many would consider anesthesia today six sigma. This has come about first by reviewing closed cases with problems, then addressing near misses and also by eliminating explosive gases such as cyclopropane. The Foundation [APSF] serves as a clearing house for safety and quality issues in anesthesia. University Hospital Consortium (UHC) UHC began an aggressive patient safety program about three years ago consistent with the needs and desires of its constituent hospitals. Included in this is an internet based system for reporting errors and near misses. The system is used in the perioperative setting as well as the rest of the hospital and has developed some much needed and useful information. However, given a lack of expressed interest by the constituent CEOs, there is no organized program within UHC related specifically to the issue of error and safety in the OR or Perioperative patient safety. Health Care Advisory Board (HCAB) The HCAB has done extensive work on medication safety and safety issues overall but nothing focused on OR or Perioperative patient safety. They find that their constituent hospital CEOs and COOs and even the VPs of Quality are not currently interested in OR safety and hence they have not engaged their work force on this area. They do find that perioperative managers and some surgeons have asked for help in addressing OR safety. Agency for Health Care Research on Quality (AHRQ) AHRQ has an extensive research program devoted to patient safety. Its first National Healthcare Quality Report was recently released for 2003. In its pursuit of quality, the report focuses on five major goals: Reduce Medical errors Increase evidence-based practices Improve the systems for reporting errors Encourage the use of electronic medical records Improve patient protections

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Medication Error Prevention as a Model for a Program in Perioperative Safety Since medication errors are the most frequent errors The Medication Process In A made in the hospital, much Hospital attention needs to be placed Unit Clerk here. The process of Transcribes Physician Order medication delivery has Pharmacist Writes Order Fills Order three separate components, each with multiple subcomponents. First, the physician orders a drug for a patient; then the pharmacy processes the order and finally the nurse Medication Nurse Nurse Delivered to Administers administers the drug. In Checks Unit Medication Order actual practice, there are and Charts many steps and also multiple checks and balances to assure that errors do not occur. Ordering Physicians are famous for apparent poor handwriting. Whether or not the injunction is true, the problem accounts for a large number of errors or at least the need to Physician As Received At Pharmacy Physician OrderOrder As Received At check with the physician for clarity. In Pharmacy some hospitals, the orders are transcribed Paper Medication Order by a clerk for transmittal to the pharmacy. The clerk may be very careful but is not trained in drug therapy so an error from misreading handwriting is common. Generally, a nurse is to cross check the transcription before it is sent off but during busy times this may not occur or the nurse may misread the handwriting. Some 60% of all medication errors occur during this set of steps.
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Preparation in the Pharmacy Todays hospital pharmacy includes many checks and balances to assure safety but mistakes still occur. First is that the order is misinterpreted. Some hospitals avoid the clerk transcription error by faxing the physicians order directly. But it is not uncommon for the pharmacist to have difficulty interpreting the order. This leads to calls and pages

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but if there is no immediate answer or if the pharmacist thinks he understands the order, it is prepared. [The graphic is for a patient about to go to the OR for kidney transplant.] Many drugs today come from the manufacturer prepackaged in what are called unit doses or packets that are consistent with common prescribing practices. This Pharmacy Drug Bins eliminates error in measuring liquids. Readers are all familiar with the little packages of cream cheese that are served today in restaurants instead of a slab. For the restaurant this reduces waste and assures that the product is clean when served. In the pharmacy there are

bins, alphabetically arranged with unit doses of various liquid drugs. Imagine that the physician orders metachlopramide for a patient, three times per day. The pharmacist goes to that bin and pulls out three containers, checks the labels and puts them in a tray that will go to the patients floor. Unfortunately, many of these packets look alike and are easy to mistake. Imagine that the patient gets the packet from the next bin by mistake milk of magnesia. After three doses of that today, he will be an unhappy camper tomorrow. Not the worst of errors but still a problem. Other drugs must be placed into an intravenous solution. This requires taking the drug from the shelf in its vial, inserting a needle on a syringe to withdraw the correct amount and then injecting the drug into the intravenous fluid in a bag. Here an error that has been frequently recognized is that the drug may come in various concentrations. A pharmaceutical manufacturer always wants to have all of their packaging look alike their brand. But a look alike package is potentially deadly if a higher concentration is pulled off the shelf by mistake; an equal amount of fluid removed from the vial might mean a dangerous or even fatal dose into the intravenous bag. One approach on medical floors is to simply not allow high, i.e. dangerous, concentrations of drugs on the floor where less trained but enthusiastic staff might make a mistake. For example, high concentrations of potassium if not diluted properly can cause the heart to stop when given intravenously. So it is best to just not have the high 40

concentration vials around where someone might misread the label. This simple step has led to big reductions in this error that, unfortunately, was not all that rare. Pills are often also packaged in unit of use plastic bags with a label. The pharmacist can then select the proper pills for a patient without having to open and count from a large container each time. Alternatively, the pill is prepackaged in individual blister packs by the manufacturer and come with a label noting name and strength. The packaged pills or capsules are placed in bins just like the unit does of liquids noted above. Of course the same errors can occur. Consider two pills that look much alike. It is all too easy to select the wrong package. Yes, they each have a label but sometimes the eye just does not see the mistake. Delivery to the Floor and Administration of Medications The prepared drugs are delivered by the pharmacy to the individual floors or units in the hospital. Each patient has a tray or drawer in a chest that is stationed in the hallway near where the nurse is working. All of Mr. Millers medications are in that tray. The tray may be divided into front and rear compartments to separate what he is definitely to be given today and what he may have if he wishes or needs (e.g., sleeping pill or pain medication.) The nurse is expected to check her medication order card and select the proper medications from the tray. She also has a notification on her medication card about any allergies or other potential medication issues. She will double-check this against the drugs that she is about to administer to be sure that nothing will cause the patient a problem. Her medication card also indicates the dose and route as transcribed from the physicians order. If anything doesnt match up, she will double check the original doctors order or call the physician if she has a question or concern. Once checked, she takes the medicine to the patient and then marks down that it was given. Depending on the patient and the drug, she may stay with the patient to actually observe that it was taken. At the end of the day or shift there should be nothing left over in the front half of the tray. All of these steps are set up to assist with patient safety related to medications. But errors can still occur. A drug gets into the wrong tray or the nurse opens the wrong tray to take out a medication. It looks correct and it is given. Or, the nurse misses the fact that the patient is known to be allergic, just as the doctor did when signing the original order. Or something has happened to the patients kidneys and the original order is no longer appropriate but the adjustment has not yet been ordered. Will the nurse know or not? New Approach To Improve Safety of Medications

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What can be done to reduce these errors? Humans will still make mistakes so just more training and admonitions to be careful are not enough. The various checks and balances built in now are good but not good enough. Here is a New Approach To Medication new way of approaching medication safety. Process First, address the Order Automatically Pharmacist environment of safety by Enters Pharmacy Checks Order Physician Orders Software Via Computer getting commitment from the top of the organization including the Board of Robot Selects Directors that safety is Medication Using Bar Codes critical and that the needed R D Patient ID Checked resources will be With Bar Code. Medication Checked forthcoming. Banish the With Bar Code. Drug Administered culture of punishment for RN Enters Patient & making an error and Self ID - Removes Medication Placed Into replace it with a culture Medication Omnicell that embraces reporting safety concerns. Collect the information, analyze it, do root cause analyses and report back to the involved staff on new approaches and systems.
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Second, be sure that the pharmacy is directed by a true leader with vision and commitment to safety. He or she must also have the requisite management skills and ability to team with doctors and nurses. Begin training programs for the staff up and down the chain of medication ordering, preparation and administration. Initiate some changes that attack human factors as a third step. For example, eliminate high concentrations of potassium chloride from patient care areas, improve labeling of medication bins in the pharmacy and keep drug packages with different dosages separated from each other. Then, as a forth step, begin to introduce technologies that will assist the staff in this new approach, which is described below. The physician does all ordering via the computer. He or she signs in with name and password and then scrolls to his patients record. Only the appropriate physician has access to actually creating or changing a medication order for this particular patient. . Others can see the order but cannot Physician Orders Via Computer make changes. The physician now writes the medication, including dose, route, and number of times per day. The computer will query the reason for the order. For example, an antibiotic is ordered for pneumonia. If the patient is known to be allergic, the computer will not accept the order. If the dose is inappropriate for the patients height and weight it will challenge the order or assist the physician to calculate the correct dose. If the patients

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kidneys are malfunctioning (known to the computer because the blood tests of kidney function are also incorporated into the system) it will alert the physician to adjust the dose and, again, assist in that calculation. If the patient is receiving other drugs that might interact adversely with the new drug the computer will so inform the physician. If the antibiotic chosen for pneumonia is not among those usually used for pneumonia the computer will also query the doctor, even suggesting alternatives. All of these steps will be instantaneous and convenient. There are some problems. First, these are new systems and they are constantly being updated and upgraded. The basics work well but the added elements are still developing. Clearly, such a system eliminates the handwriting error. It eliminates the allergy error. So mistakes will be much lessened. By adding in knowledge such as drug-drug interaction, kidney function and choice of antibiotic, the physician is given much additional help and is taught all at the same time. The training comes at the perfect moment. Doctors learn best when faced with an issue, such as what is the best antibiotic to prescribe right now for pneumonia, not some other time such as when the doctor is reading at home about pneumonias from a textbook. Drug Preparation in the Pharmacy If the order comes from the physician via the computer there is no chance for misreading handwriting. That is a big first step that reduces errors immensely. The pharmacist can review the order, see how it has been adjusted or not for kidney function, other drugs being administered and dosed for weight and height. The computer can set up alerts and alarms to the pharmacist for any order that was sent despite the computers advice. The pharmacist does not have to enter the order into the pharmacy computer; it is done automatically. Drugs can be selected from the bins described above and then scanned with a bar code just as in the supermarket. This not only records that the drug was placed in the patients tray but it cross checks the selection as being correct. Is it the right drug, right dose, right number of doses for the day? If the pharmacist or pharmacy technician selects the wrong (e.g., higher, more dangerous) concentration of the drug, the bar code reader alerts the computer which in turn stops the process. This will dramatically decrease the chance for taking higher concentrations of a drug and mistakenly under or over diluting it for addition to an intravenous bag of fluid. Further, the computer, having checked the concentration of the drug in the vial and knowing what is needed to add to the IV solution now prompts the pharmacy technician with the correct amount to withdraw. Perhaps better yet, an infusion robot is utilized to select the proper compound, add diluent, remove the required amount and inject it into an infusion bag for delivery and administration. The computer provides a label which gives the drug name, dose, , diluent, the date and time for administering and the rate it is to be administered to the patient,

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Pills, capsules, and liquids packaged in unit doses or units of use can be stored and retrieved by a pharmacy robot. The robot is Pharmacy Robot given directions by the computer that in turn is following the doctors orders, as checked and verified by the pharmacist. The robot selects the ordered drugs, checks its bar code and delivers it to the patients tray. Basically, the robot has a special arm that grasps the package and moves it to the tray. The process actually starts by having the robot stock a location with multiple sets of the bar coded prepackaged drug, The robot knows" the location and will return there when it needs that drug for a patient. But it still double checks by reading the bar code on the drug package before proceeding. If somehow a drug got into the wrong location, the robot will pick it up and put it into a discard tray. Another robot, designed for delivering supplies to hospital units can be modified to deliver medications. It is programmed to take its stock from the pharmacy, and like R2D2, travel down the hallway, onto the elevator (which it calls by wireless technology) and to the nursing unit. On arrival, it states I have medications for you and the nurse with the appropriate password opens the robots cabinet and removes the drugs, perhaps placing them in the distribution cart discussed next. Another new step in Omnicell At A Glance protecting the patient is a special distribution cart or case on the hospital unit floor. Instead of a cart with multiple drawers or trays that can be opened by anyone, the new system has multiple built in features. First, the robot or pharmacy technician loads the cart with the various patients trays. The cart is connected with the computer that knows the patients order and what the pharmacy has prepared. The nurse goes to the cart but cannot open it. Instead, she must first sign in with her name and password and the patients name. A nurse from elsewhere in the hospital not assigned to that floor will not have access to this cart. Next, the nurse indicates which drug she wishes to withdraw. The computer and nurse co-verify the choice and the patients drawer (and only that patients drawer) opens automatically. The nurse removes the desired medication, swipes it across the bar code reader on the cart to verify both that it is correct and that it was removed.

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She then goes to the patients room, swipes the patients bar code enhanced wrist identification band and gets an approval from her wireless computer which is, in turn, connected wirelessly to the hospital clinical information system including the medication ordering software. Patient Bar Code Identification Once the approval is posted, the drug is given and the system registers the transaction as completed eliminating that paperwork from the nurses routine. From end to end there is a continuous check on the order; continuous record of who was involved (doctor, pharmacist, pharmacy technician, nurse;) continuous record of any changes made, why and by who and with whose approval; assurance that the right drug got to the right patient at the right time in the correct Medication Administration dosage and route; and a record of when the Record (MAR) medication was actually administered or swallowed. In addition, if mistakes were made and the computer issued a correction or alert, there can be a record of these as well. The latter is an interesting issue. Consistent with the airline pilots agreement to report errors and near misses with the promise of anonymity, it might be best to keep this data unconnected with the individuals involved. As a result, physicians, nurses and pharmacists become willing to use the computerized system without fear of reprisals yet the institution can collect very valuable data to edit so that recurrent errors can be dealt with by added system changes. Of course it would also be valuable to learn that a particular doctor repeatedly made the same mistake. In this instance, he or she could be offered some form of remediation but this would break the anonymity. This model for medication ordering, preparation, delivery and administration is technology heavy yet utilizes people (physician, pharmacist and nurse) for their expertise and skills while eliminating opportunities to make an error or by detecting errors as they occur. Further it incorporates knowledge into the system thereby teaching as a byproduct of the work done by each. Finally it can be used as a data collection tool to address common near misses and common error pathways so that patterns of error can be recognized and further systems can be put in place to prevent those errors as well. Summary The OR can be approached in a manner as done for medications. First, create the environment of safety with high level commitment and provision of resources. Initiate a training program, eliminate the culture of punishment for errors, and begin a mechanism

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to collect, analyze and feed back information on errors and near misses with the intent to correct or change processes. In addition, assign a strong leader with excellent vision; appoint an effective manager and work together to empower all involved to immediately speak up about perceived errors or problems. To this new environment introduce technologies to further improve safety: the electronic medical record, a surgical information system that actually assists the professional staff, video, simulation, robotics and patient, staff and equipment identification devices. Any one will aid the staff to reduce errors; together these approaches can have a major impact to enhance safety. Closing Comments Dr Sherwin Nuland, a highly respected surgeon at Yale New Haven Medical Center writes in the New England Journal of Medicine of his introduction to surgical safety. As a third year student on his surgical rotation he is suddenly finds himself as a subintern for a week. Assigned to assist a well known senior private surgeon, he is left alone at the end of the operation to close the wound. Of course he is a novice and makes the mistakes of a novice, which lead to a wound infection some days later. Now, many years later, he reflects that so many errors were made that day. The senior surgeon should have determined his assistants skills before leaving; the student should have identified himself as such; the nurses and anesthiologist should have objected that the surgeon planned to depart; the surgeon should have had a less packed operative schedule that day. Had any one of these errors been avoided, then Nulands surgical error that led to infection would have been prevented. Nuland closes his commentary that systematic approaches are important but that it is essential that each person must be watchful, alert to failures of human compensatory mechanisms.

Recommendations to TATRC The Roadmap What follows are the authors recommendations that TATRC should consider in advancing the OR and perioperative patient safety agenda relative to the entire OR of the Future initiative. First -Develop a strong understanding and underpinning of the patient safety issue among TATRC staff, collaborators and partners and among other Department of Defense agencies. Involve, invest and include participation and discussion with leaders of the hospital community, regulators, government agencies and others with an interest in patient safety. Do so by initially organizing a national invitational strategy meeting (IRT) to discuss OR and perioperative patient safety parameters and, from that discussion, develop the outlines of a roadmap for future work.

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The IRT should address the three key elements of: 1) the environment/culture of safety, 2) human factors and 3) technologies. Despite TATRCs commitment to technology advancement, the safety agenda must encourage attention by its partners and collaborators to environment/culture and human factors as well. Second- Write and publish white papers on the key issues to be addressed as a result of the strategy development from the IRT. Third- Given that the data on OR and perioperative errors and near misses is inadequate, immediately propose a set of linked contracts to carefully and thoroughly determine the nature of errors and near misses as they currently occur in the perioperative and OR setting. Fourth- Encourage all collaborators and partners to engage in the patient safety strategy by specifically proposing research projects that address safety as the primary aim and build upon the information developed above.

Some greater detail: The proposed linked projects (contracts) to observe and define the error and near misses in the OR settings are outlined below. Proposed Project # 1 There is currently limited, unbiased, comprehensive data available on the types, causes, incidence and severity of errors and near misses that occur in the perioperative environment. However, before embarking on a project to measure the common and serious near misses and errors in the OR and perioperative environments (Proposed Project #2), it is critical to first more fully understand the nature and types of potential and actual errors in this setting. The process should begin with a better understanding of the patient pathway through the operating room and beyond. This needs to be elucidated during the entire pre, during and post operative event beginning with the patient evaluation by the surgeon. The initial output of the project is to create a process map of the patients pathway. This will include determining the processes that underlie this entire pathway , such as registration, preoperative evaluation, risk analysis and identification, supply chain for instruments and equipment including sterile processing, the operative procedure itself, time in the post acute recovery unit (PACU) or intensive care unit (ICU), transport form OR to PACU or ICU, the handoffs," etc. Critical to this analysis is to assess the risk points in the process, those points where human error is most likely.

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In general, it is envisioned that TATRC will select a contractor that will create a Process Map based upon close evaluation of four to six institutions with large operating suites (defined here as ten ORs or more) with 40 or more procedures per day, preferably among those academic medical centers that are currently participating in the OR of the Future agenda with TATRC. The selected contractor must demonstrate familiarity with Process mapping Large (academic) medical institutions TATRC OR of the Future agenda Organizations with complex interpersonal activities Organizations with complex programmatic operations Proposed Deliverables Process Map of Perioperative environment Recommendations, based on the process mapping, for Assessment of the key risk points along the process map Suggested immediate safety interventions based on mapping outcomes Human and Technology factors that could lead to improved safety Selection of best currently available monitoring methods to assess patient safety in the perioperative environment (e.g.,University Hospital Consortium internet based process for error data collection and analysis; Center for Performance Sciences Quality Indicator Project, etc.) Proposed Time Line Six months from receipt of contract until completion of process mapping at 4 to 6 institutions Two additional months to complete recommendations and prepare report

Proposed Project #2 There is currently limited, unbiased, comprehensive data available on the types, causes, incidence and severity of errors and near misses that occur in the perioperative environment. This project aims to study the perioperative environment for the types of errors that are both most common and most serious, as defined in Proposed Project #1, using the currently available, recommended monitoring system(s) identified in Project #1. In general, contractor will Study the perioperative environment for errors, adverse events and near misses Employ the monitoring system(s) identified in Project #1 Enumerate specific errors and classify them as to level of potential importance (i.e., near miss, error, adverse event, serious sequalea) Relate errors to the number of procedures preformed to develop incidence rates

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Complete limited root cause analysis of the Most common errors Most serious errors So as to recommend early actionable approaches to reducing errors It is anticipated that the contractor will Utilize trained individuals to directly observe for errors and near misses Enter the data into the selected monitoring system(s) Work with the monitoring system vendor(s) to analyze the data to achieve the goals noted above. Data Collection Data is to be collected from 4 to 6 institutions with large and active ORs (see Project #1), each preferably chosen from current TATRC partners and collaborators. Proposed Time Line From receipt of contract Three months to Acquire IRB approvals Select and train observers Nine months to Complete data acquisition Twelve months to Complete analysis and prepare report

Notes: It is suggested that it not be the intention of TATRC that this project will elucidate all errors in all possible OR procedures but rather will identify with sufficient rigor the common errors and the most important errors (i.e., those causing the most severe or adverse consequences) across a broad range of operative procedures. In the course of the research, it is anticipated that Broad trends will emerge and be recognized The monitoring system(s) will be tested and modified as appropriate Critical lessons will be learned about the actual incidence of errors and near misses, plus the factors that most likely predispose to their occurrence. It is suggested that it be the intention of TATRC that these lessons learned will be the basis for Review of results with the participating institutions and TATRC staff Presentation(s) at appropriate meetings Publication(s) in appropriate venues Further it is suggested that it be the intention of TATRC to utilize this material to

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Stimulate a national dialogue on patient safety in the OR Encourage its partners and collaborators to propose future research projects on patient safety Assist national organizations (e.g., Joint Commission on Accreditation of Healthcare Organizations (JCAHO), American College of Surgeons (ACS), Association of Operating Room Nurses (AORN), Anesthesia Patient Safety Foundation (APSF), others) to develop their agenda and mandates related to patient safety. Finally, it is suggested that TATRC look to the completion of this project for information that will point to technologies in the TATRC portfolio such as simulation, robotics, video, and information management/technology that could appropriately be directed toward enhancing patient safety.

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