Patient Safety in the Operating Room

1. Patient Safety in the Operating Room Carlos L. Rodriguez, MD Baylor College of Medicine Department of Anesthesiology

2. Patient Safety in the Operating Room History in Medicine and Anesthesia Innovations in Anesthesia Safety Advocacy Current Events in Anesthesia Sentinel Events and The Joint Commission Aviation and its role in anesthesia Anesthesiology and its role in patient safety

3. History in Medicine and Anesthesia Hippocrates - �the father of medicine� Hippocratic Oath: �I will apply, for the benefit of the sick, all measures [that] are required, avoiding those twin traps of overtreatment� 1. Hippocrates--lived near the time of 400 BC, called for all physicians to provide safe and effective care and thus was created the hippocratic oath 2. First version written by Hippocrates in Greek and modern version rewritten by Louis Lasagna in 1964; although safety is never mentioned, the idea of creating of safe environment for the patient is implied.1. Hippocrates--lived near the time of 400 BC, called for all physicians to provide safe and effective care and thus was created the hippocratic oath 2. First version written by Hippocrates in Greek and modern version rewritten by Louis Lasagna in 1964; although safety is never mentioned, the idea of creating of safe environment for the patient is implied.

4. Innovations in Anesthesiology The Anesthesia Machine Patient Monitors Electrocardiograph Arterial blood gas analysis Pulse oximetry Endotracheal Intubation Pain Control The Anesthesia Machine is more accurate at delivering a calibrated amount of gas and volatile anesthetic. The creation of new sophisticated patient monitors has allowed to reduce the morbidity and mortality of surgical procedures�we are now able to take care of sicker patients. Being able to intubate patient freed the anesthesiologist from having to mask ventilate; The anesthesiologist is now able to attend to other aspects of patient care. Better pain control, enhanced patient care and promoted development of surgical procedures. The Anesthesia Machine is more accurate at delivering a calibrated amount of gas and volatile anesthetic. The creation of new sophisticated patient monitors has allowed to reduce the morbidity and mortality of surgical procedures�we are now able to take care of sicker patients. Being able to intubate patient freed the anesthesiologist from having to mask ventilate; The anesthesiologist is now able to attend to other aspects of patient care. Better pain control, enhanced patient care and promoted development of surgical procedures.

5. Innovations in Anesthesiology The creation of the anesthestic delivering system Late 19th Century: freestanding anesthesia machines were manufactured in the United States and Europe. Before 1900: S. S. White Company modified and marketed its continuous-flow machine 1906: carbon dioxide absorbers used by Kuhn 1910: Elmer McKesson uses nitrous oxide therapeutically 1912: reducing valves added to the anesthesia machine 1912: water-bubble flow meters allowed the proportion of gases and their flow rate to be approximated 1. Introduction of sophisticated monitoring is critical to the increase in patient safety; advances in technology , including components of the anesthesia machine, which produced more accurate anesthetics have thus made it safer, as well. Better monitors such as ECG, blood gas analysis, pulse oximetry has reduced the morbidity and mortality of surgical procedures 3 American dentist- entrepreneurs (Samuel S White, Charles Teter, and Jay Heidbrink developed the first series of US instruments to use compressed cylinders of nitrous oxide and oxygen. Elmer McKesson one of the first specialists in anesthesiology used nitrous oxide to its therapeutic limit by using it to perform inductions with 100% concentration of the drug Franz Kuhn, a German surgeon, used carbon dioxide absorbers through the lengths of his surgeries�.a few years later the first american machine with a a CO2 absorber was independently manufactured by DENNIS JACKSON. 1. Introduction of sophisticated monitoring is critical to the increase in patient safety; advances in technology , including components of the anesthesia machine, which produced more accurate anesthetics have thus made it safer, as well. Better monitors such as ECG, blood gas analysis, pulse oximetry has reduced the morbidity and mortality of surgical procedures 3 American dentist- entrepreneurs (Samuel S White, Charles Teter, and Jay Heidbrink developed the first series of US instruments to use compressed cylinders of nitrous oxide and oxygen. Elmer McKesson one of the first specialists in anesthesiology used nitrous oxide to its therapeutic limit by using it to perform inductions with 100% concentration of the drug Franz Kuhn, a German surgeon, used carbon dioxide absorbers through the lengths of his surgeries�.a few years later the first american machine with a a CO2 absorber was independently manufactured by DENNIS JACKSON.

6. Innovations in Anesthesiology The creation of the anesthestic delivering system During the same period, Draeger and son adapted compressed-gas technology 1915: New technology allows for the use of the closed anesthesia circuit. Soda Lime was introduced 9 years later. 1930: Further innovations led to creation of unidirectional valves, circle system, and an in-circuit carbon dioxide absorber. Glass vaporizers for ether transformed into today�s high-tech vaporizers!! Dennis Jackson, a pharmacologist, developed an early technique of carbon dioxide absorption that permitted the use of a closed anesthesia circuit Ralph Waters introduces a simpler absorption device using a soda lime canister. Uncalibrated glass vaporizers were suitable for the adminstration of ether. In the presence of stronger anesthetic agents, though, these vaporizers could provide to be deadly. The inspired concentration of agents could not be determined with accuracy (drugs such as chloroform could be lethal). Glass to Copper Kettle to Agent Specific!!!Dennis Jackson, a pharmacologist, developed an early technique of carbon dioxide absorption that permitted the use of a closed anesthesia circuit Ralph Waters introduces a simpler absorption device using a soda lime canister. Uncalibrated glass vaporizers were suitable for the adminstration of ether. In the presence of stronger anesthetic agents, though, these vaporizers could provide to be deadly. The inspired concentration of agents could not be determined with accuracy (drugs such as chloroform could be lethal). Glass to Copper Kettle to Agent Specific!!!

7. Innovations in Anesthesiology Advances in Monitoring Intraoperative Blood Pressure Monitoring Electrocardiography Pulse Oximetry Detection of exhaled gases Harvey Cushing (surgeon) developed interest in intraoperative BP monitoring, introduced the concept in 1902 and had BP recorded on the anesthesia record. Since this time, BP monitoring has evolved into automatic noninvasive blood pressure cuffs and intraarterial blood pressure monitoring. Electrocardiography (ECG): after 1928 cathode ray oscilloscopes were available but the risk of explosion in presence of inflammable anesthetics did not allow routine use until after WWII Pulse oximetry was first designed during WWII. It was originally used as a probe placed on fighter pilots ear lobes to detect presence of oxygen delivery while inside unpressurized aircraft. Developments later facilitated use within the operating room Infrared absorption (beginning in 1954) led to visually displayed concentrations of exhaled carbon dioxide and now routinely expired concentration of inhalational anesthetics which help in detection of endotracheal vs esophageal intubation and also exhaled drug concentrations.Harvey Cushing (surgeon) developed interest in intraoperative BP monitoring, introduced the concept in 1902 and had BP recorded on the anesthesia record. Since this time, BP monitoring has evolved into automatic noninvasive blood pressure cuffs and intraarterial blood pressure monitoring. Electrocardiography (ECG): after 1928 cathode ray oscilloscopes were available but the risk of explosion in presence of inflammable anesthetics did not allow routine use until after WWII Pulse oximetry was first designed during WWII. It was originally used as a probe placed on fighter pilots ear lobes to detect presence of oxygen delivery while inside unpressurized aircraft. Developments later facilitated use within the operating room Infrared absorption (beginning in 1954) led to visually displayed concentrations of exhaled carbon dioxide and now routinely expired concentration of inhalational anesthetics which help in detection of endotracheal vs esophageal intubation and also exhaled drug concentrations.

8. Safety Advocacy American National Standards Institute (ANSI) Committee Z79 1956-1983: sponsored by the American Society of Anesthesiologists (ASA) Now a part of the American Society for Testing and Materials with representatives from industry, government, and health care professions Coordinates the introduction of safety features Advances made by the committee: Created standards for face mask orifice and endotracheal tube connectors Mandated touch identification of oxygen flow control Pin indexing Diameter indexing

9. Safety Advocacy Anesthesia Patient Safety Foundation Launched in 1985 by the American Society of Anesthesiologists (ASA). It is a stand-alone organization solely devoted to patient safety. Vision statement: No patient shall be harmed by anesthesia. 1986: Urges the ASA to make pulse oximetry and the capnograph standard monitors. 1994: Makes recommendations for absorbants to be changed more frequently after studies show risk of carbon monoxide poisoning. APSF.org

10. Recent Events in Anesthesia On February 20th, 1995, Willie King, a 51 year old diabetic, has his left leg instead of right leg amputated. This mistake resulted in eventual bilateral lower extremity amputations. On February 7th, 2003, Jesica Santillan underwent a double lung-heart transplant with new organs of the wrong blood type. Human error and lack of safeguards were blamed for the lack of accuracy in blood typing. New steps in the confirmation of blood typing are now in place. The costs charged against the hospital and surgeon were more than 1 million dollars and a temporary ban on elective surgeries. Thus, helping to increase medical care costs and preventing other patient�s in need from having their surgeries. And, forever, affecting the life of the patient. Santillan was a 17 year old Mexican immigrant who came to America 3 years prior to her surgery seeking medical help. Knowledge of the incorrect blood typing of organs in this patient was not known until the end of the surgery but at this time, the patient�s body was already rejecting her new organs. The patient then received a new set of organs 3 days later but the damage was irreparable. She later developed brain edema and kidney failure, which resulted in death. Duke has put steps in place to prevent such mistakes from happening again. Among other measures, three crucial members of the transplant team -- the transplant surgeon, the transplant coordinator and the doctor who harvests the organs -- will confirm the blood type of the donor and recipient match.The costs charged against the hospital and surgeon were more than 1 million dollars and a temporary ban on elective surgeries. Thus, helping to increase medical care costs and preventing other patient�s in need from having their surgeries. And, forever, affecting the life of the patient. Santillan was a 17 year old Mexican immigrant who came to America 3 years prior to her surgery seeking medical help. Knowledge of the incorrect blood typing of organs in this patient was not known until the end of the surgery but at this time, the patient�s body was already rejecting her new organs. The patient then received a new set of organs 3 days later but the damage was irreparable. She later developed brain edema and kidney failure, which resulted in death. Duke has put steps in place to prevent such mistakes from happening again. Among other measures, three crucial members of the transplant team -- the transplant surgeon, the transplant coordinator and the doctor who harvests the organs -- will confirm the blood type of the donor and recipient match.

11. The Joint Commission The Joint Commission evaluates and accredits more than 15,000 health care organizations and programs in the United States. It reviews organizations� activities in response to sentinel events in its accreditation process.

12. Sentinel Events A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase, "or the risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called "sentinel" because they signal the need for immediate investigation and response.

13. The Sentinel Event Policy The policy has four goals: To have a positive impact in improving patient care, treatment, and services and preventing sentinel events To focus the attention of an organization that has experienced a sentinel event on understanding the causes that underlie the event, and on changing the organization�s systems and processes to reduce the probability of such an event in the future To increase the general knowledge about sentinel events, their causes, and strategies for prevention To maintain the confidence of the public and accredited organizations in the accreditation process

14. Root Cause Analysis and Action Plans Root Cause Analysis is a process for identifying the basic or causal factors that underlie variation in performance, including the occurrence or possible occurrence of a sentinel event. A root cause analysis focuses primarily on systems and processes, not on individual performance. The product of the root cause analysis is an action plan that identifies the strategies that the organization intends to implement in order to reduce the risk of similar events occurring in the future. The plan should address responsibility for implementation, oversight, pilot testing as appropriate, time lines, and strategies for measuring the effectiveness of the actions.

15. Joint Commission Recommendations Anesthesia awareness is under-recognized and under-treated in health care organizations. The Joint Commission recommends that health care organizations which perform procedures under general anesthesia do the following to help prevent and manage anesthesia awareness: Develop and implement an anesthesia awareness policy that addresses the following: Education of clinical staff about anesthesia awareness and how to manage patients who have experienced awareness. Identification of patients at proportionately higher risk for an awareness experience, and discussion with such patients, before surgery, of the potential for anesthesia awareness. The effective application of available anesthesia monitoring techniques, including the timely maintenance of anesthesia equipment. Appropriate post-operative follow-up of all patients who have undergone general anesthesia, including children. ? The identification, management and, if appropriate, referral of patients who have experienced awareness. Assure access to necessary counseling or other support for patients who are experiencing post-traumatic stress syndrome or other mental distress.

16. Learning From Aviation Similarities between physicians and pilots Work in complex environments Interact with technology Risk varies from low to high Threats come from a variety of sources

17. Learning From Aviation Safety is important to both professions, BUT in aviation accidents, although infrequent, they are highly visible and often have massive casualties! NASA reports accidents in aviation involve 70 % human error. Causes of error often include: cognitive overload, fatigue, workload, poor interpersonal communication, flawed decision making (and the list goes on�) Lack of teamwork can also lead to team error.

18. Learning From Aviation Aviation increasingly uses error management strategies to improve safety�(i.e. understanding the error, recognizing the types of conditions that led to the error, determine what can be done to prevent the error, and train personnel to become equipped to handle these situations) Obtaining Data Confidential surveys, non-punitive incident reporting systems National aviation incident reporting systems Line Operations Safety Audit (LOSA) Crew Resource Management Simulation The pilot�s professional culture shows a negative component in denying personal vulnerability, confidential surveys allow for junior pilots speaking up when problems are observed and leaders soliciting and accepting inputs help define a safety climate. Non punitive incident reporting systems �these provide insights about condtiions that induce errors and the errors that result. The US and many other countries have National aviation incident reporting systems so that data can be shared to better understand and survey errors. Line Operations Safety Audit (LOSA)�information collected at the University of Texas which uses expert observers in the cockpit and they record threats to safety, errors and their management, and behavior identified as critical in preventing accidents�.confirm that threat and error are ubiquitous�.help to differentiate need for technical training vs. team training. CRM considers the human aspect of training whereas before only technical aspects of flying were taken into consideration. It considers human performance limiters (such as fatigue and stress) and the nature of human error, and it defines behaviours that are countermeasures to error, such as leadership, briefings, monitoring and cross checking, decision making, and review and modification of plans�.now required for flight crews worldwide, and data support its effectiveness in changing attitudes and behaviour and in enhancing safety. The pilot�s professional culture shows a negative component in denying personal vulnerability, confidential surveys allow for junior pilots speaking up when problems are observed and leaders soliciting and accepting inputs help define a safety climate. Non punitive incident reporting systems �these provide insights about condtiions that induce errors and the errors that result. The US and many other countries have National aviation incident reporting systems so that data can be shared to better understand and survey errors. Line Operations Safety Audit (LOSA)�information collected at the University of Texas which uses expert observers in the cockpit and they record threats to safety, errors and their management, and behavior identified as critical in preventing accidents�.confirm that threat and error are ubiquitous�.help to differentiate need for technical training vs. team training. CRM considers the human aspect of training whereas before only technical aspects of flying were taken into consideration. It considers human performance limiters (such as fatigue and stress) and the nature of human error, and it defines behaviours that are countermeasures to error, such as leadership, briefings, monitoring and cross checking, decision making, and review and modification of plans�.now required for flight crews worldwide, and data support its effectiveness in changing attitudes and behaviour and in enhancing safety.

19. Learning From Aviation The operating room is similar to the cockpit in that differing specialties work together to treat a patient (aircraft are more predictable than patients!). Behaviors observed that could place patient at risk: Failure to inform team of patient�s problems Failure to discuss alternative procedures Failure to establish leadership Overt hostility and frustration Failure to plan Failure to monitor situation and other team�s activities Pilots and doctors have common interpersonal problem areas and similarities in professional culture. Threats (factors that can increase likelihood of errors) are always present.

20. Learning From Aviation Aviation experience can be used to improve patient safety by: Confidential Incident Reporting Systems and surveys Systematic Observations of Team Performance Details of adverse events and near misses Dealing with latent factors that have been detected Changing the organizational and professional cultures Providing performance standards Non-punitive approach to errors Providing formal training in teamwork Providing feedback and reinforcement on both interpersonal and technical performance Making error management an ongoing commitment!!!

21. Anesthesiology and Its Role in Patient Safety Anesthesia is safer today!!! Mortality is 1:200,000-1:300,000 Technology Implementation of technological solutions to clinical problems Engineered safety devices (pin index safety system) New technology Standards and Guidelines Development allowed for guidance and direction for the diagnosis, management, and treatment of specific clinical problems Human Factors Analysis of tasks Anesthesia is safer today than it was 25-50 years ago!!!! The Institute of Medicine reports that over the past 2 decades anesthesia deaths have decreased from 1:5000 to 1:200,000 to 1:300,000 Anesthesiologists have become experts at realtime monitoring of patients (ie ECG, pulse oximetry, and capnography) There have been advances tha physically prevent errors from being made�these are considered engineered safety devices. New technology such as new ways to intubate patients (fiberoptically) have made many advances towards better patient care.Anesthesia is safer today than it was 25-50 years ago!!!! The Institute of Medicine reports that over the past 2 decades anesthesia deaths have decreased from 1:5000 to 1:200,000 to 1:300,000 Anesthesiologists have become experts at realtime monitoring of patients (ie ECG, pulse oximetry, and capnography) There have been advances tha physically prevent errors from being made�these are considered engineered safety devices. New technology such as new ways to intubate patients (fiberoptically) have made many advances towards better patient care.

22. Anesthesiology and Its Role in Patient Safety Patient Simulation Computer Screen Mannequin 1. Analysis of decision making processes with various methods, including direct observation, review of video tapes of real cases, assessing descriptions of cases, and use of patient simulators dates back approximately 30 years. 1. Analysis of decision making processes with various methods, including direct observation, review of video tapes of real cases, assessing descriptions of cases, and use of patient simulators dates back approximately 30 years.

23. Anesthesiology and Its Role in Patient Safety Patient Simulation Advantages No risk to patients Many scenarios (common and uncommon) Hands on experience--use medical equipment Participants see results of decisions that have been made--errors can be allowed to occur Training in other areas can be achieved (ie teamwork) Self evaluation

24. Anesthesiology and Its Role in Patient Safety Patient Simulation Who Benefits? Education of students Training of allied health professionals Training of clinical students in routine procedures Training of residents Training of healthcare staff in crisis management Staff training in the use of clinical equipment Performance assessment Research

25. Anesthesiology and Its Role in Patient Safety A Work in Progress! Larger drop in mortality than in morbidity�errors, mistakes, and system failures still occur Death and brain damage is still seen due to accidental esophageal intubations (even with modern technology) The most basic standards are not followed uniformly Simulation training is only available to a minority of anesthesiologists Clinicians still practice while fatigued, ill, or when stressed Modern equipment is still beset by human error

26. Bibliography Archibold, Randal C. "Girl in Transplant Mix-Up Dies After Two Weeks." The New York Times. 23 Feb. 2003. �Hospital Settles Case of Amputation Error.� The New York Times. 20 Feb. 1995. Hallinan, Joseph T. �Once Seen as Risky, One Group of Doctors Changes Its Ways.� The Wall Street Journal. 21 June 2005. Barash, Paul G., Bruce F. Cullen, and Robert K. Stoelting, eds. Clinical Anesthesia. 4th ed. Philadelphia: Lippincott Williams and Wilkins, 2001. 3-24. Gaba, David M. "Anaesthesiology as a Model for Patient Safety in Health Care." BMJ 320 (2000): 785-788.