Chapter 43 Quality of Care and Patient Safety
Basic principles
1. What is the principle of nonmaleficence in regard to patient safety?
2. What elements constitute The Joint Commission National Patient Safety Goals and how often are these updated?
3. What is the triad of excellence in health care in the authors’ opinion?
4. What is included in assessing quality of care?
5. What resources are available to measure quality and efficiency in the operating room (OR)?
Anesthesiology and patient safety
6. Why is anesthesiology often considered a leader in systematic improvement of patient safety in the OR?
7. What are examples of common safety features on anesthesia machines that promote the safe delivery of anesthesia?
8. What is the American Society of Anesthesiologists (ASA) Closed Claims Database?
9. What changes in practice have resulted, in part, from the findings of the ASA Closed Claims Database?
10. What are the goals of the Anesthesia Patient Safety Foundation and who does it include?
11. What are estimates of mortality from anesthesia in today’s surgical population?
Patient Safety, Medical Error, Adverse and Sentinel Events
12. What broad types of medical or health care errors exist?
15. What are the most commonly reported sentinel events?
16. What is a root cause analysis (RCA)?
17. How many patients die annually as the result of medical errors?
18. What is the National Surgical Quality Improvement Program (NSQIP)?
19. What are the primary tenets of the NSQIP?
20. What is the central venous catheter checklist advocated for use in intensive care units (ICUs)? What is the evidence for its efficacy?
Preventing wrong-site surgery
23. What is the definition of wrong-site surgery?
24. Is the incidence of wrong-site surgery increasing or decreasing?
25. What steps has The Joint Commission taken to prevent wrong-site surgery?
26. What are the essential elements of a preprocedural “time-out”?
Medication safety
31. What is medication reconciliation in the context of anesthesia?
32. When should medication reconciliation be performed?
33. How should medication labeling be performed in the OR?
34. When should medication labeling be performed in the OR?
35. What elements of proper medication name and dose labeling help ensure patient safety?
36. How can look-alike and sound-alike drugs be differentiated?
Answers*
Basic principles
1. Nonmaleficence is a basic tenet of medical ethics based on the Latin primum non nocere, or “first, do no harm.” (746)
2. The Joint Commission National Patient Safety Goals are updated yearly, and for 2010 include the following:
3. In the authors’ opinion, (1) patient safety, (2) improved outcomes, and (3) improved patient satisfaction with their care constitutes the triad of excellence in clinical care. (747, Figure 41-1)
4. Quality of care includes not only the clinical care indicators, but also the measures of efficiency, such as timely starts, short turnaround times between cases, appropriate access for emergencies, and effective utilization of the ORs, equipment, and staff. (746-747)
5. The American Association of Clinical Directors has developed a Procedural Times Glossary to measure and compare OR efficiency benchmarks. The ASA also established the Anesthesia Quality Institute (AQI) in 2009 to establish standardized quality measures, promote research, and obtain useful data to improve the quality of patient care. (747)
Anesthesiology and patient safety
6. Anesthesiology has often been cited as an example of how a medical specialty has systematically improved patient safety. In 1954, Beecher and Todd’s review of mortality during anesthesia found a mortality rate of 1 in every 1561 operations, and was one of the first studies to scientifically identify and quantify risks associated with anesthesia. Patient safety efforts have included features on the anesthesia delivery systems used in patient care (e.g., Pin Index Systems), founding of the ASA Closed Claims Database in 1985, and establishment of the Anesthesia Patient Safety Foundation (APSF) also in 1985. (747)
7. Many of the features of the anesthesia machine, such as Pin Index Safety Systems, oxygen fail-safe controls, prevention of hypoxic mixtures, and elimination of hanging bellows, were developed to enhance patient safety by avoiding critical technical failures. (747)
8. In 1985 the ASA established the Closed Claims Database with the goal of reviewing closed malpractice claims to identify sources of technical failure and human error that lead to patient injury, and to then share this information with the anesthesia community. (747)
9. Initial findings from the Closed Claims Database found that most claims were due to unrecognized esophageal intubation or other reasons for inadequate oxygenation. This finding accelerated the requirement for pulse oximetry and capnography as standard monitors for patients undergoing general anesthesia. Several additional ASA task forces, such as the Postoperative Visual Loss Registry, have been established to further address concerns identified by analysis of the Closed Claims Database. Further analysis of problems identified by the Closed Claims Database has led the ASA to publish clinical practice recommendations such as the ASA Difficult Airway Algorithm. The ASA currently has 23 practice advisories available. (747-748)
10. The Anesthesia Patients Safety Foundation is an independent, nonprofit corporation with the goal that “no patient shall be harmed by anesthesia.” Board members include anesthesiologists, nurse anesthetists, equipment manufacturers, lawyers, and engineers. Its current mission statement identifies safety research and education, patient safety programs and campaigns, and national and international exchange of information and ideas as its continuing goals. Its quarterly newsletter is the most widely circulated anesthesia publication in the world, providing a forum to publicize advances in technology, as well as concerns regarding medications, patient issues, and common anesthesiology practices. (748)
11. Through the implementation of technical advances and practitioner education, mortality from anesthesia has improved to 1:250,000. However, as the population has aged and patients with more severe medical problems are undergoing surgery, mortality for the very ill is reported to be as frequent as 1:10,000 to 1:1500. (748)
Patient Safety, Medical Error, Adverse and Sentinel Events
12. Health care errors may be errors of commission (doing the wrong thing), omission (not doing the right thing), or execution (doing the right thing incorrectly). A defect in the delivery of care to a patient resulting in an unintended health care outcome is deemed a health care or medical error. (748)
13. An adverse event refers to any injury caused by medical care. Identifying something as an adverse event does not imply error, negligence, or poor quality of care. It simply indicates that an undesirable clinical outcome resulted from some aspect of diagnosis or therapy, not an underlying disease process. (748)
14. 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. (748)
15. From January 1995 through December 2009, The Joint Commission reviewed 6600 sentinel events; 68% of sentinel events included patient mortality. Among the 10 most frequently reported sentinel events were wrong site surgery (most common, 13.5%), operative/postoperative complication, medication error, and unintended retention of a foreign body. (748-749)
16. A Root Cause Analysis (RCA) is a structured process for identifying the causal or contributing factors underlying adverse events or critical incidents. (748-749)
17. The Institute of Medicine’s reports “To Err Is Human: Building a Better Health System” (November 1, 1999) and “Crossing the Quality Chasm: A New Health System for the 21st Century” (March 1, 2001) indicated that 98,000 patients in the United States die annually as a result of medical errors. (748-749)
18. NSQIP began at the Veterans Administration hospitals and has expanded through the American College of Surgeons to many private institutions. The NSQIP initiative endeavors to improve the delivery of medical care at a systems level rather than at an individual level and is credited with improving postoperative surgical mortality by up to 31% and morbidity by 45%. NSQIP has demonstrated that while obvious errors can be detected on the local (hospital) level, subtle systems errors or deficiencies cannot be appreciated without comparison to data from peer institutions. (749)
19. NSQIP has identified three important patient safety observations:
The Joint Commission National Patient Safety Initiative
21. The Joint Commission is an independent, not-for-profit organization, which accredits and certifies health care organizations and programs in the United States. The organization’s mission statement is “to continuously improve health care for the public, in collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel in providing safe and effective care of the highest quality and value.” (749)
22. The Joint Commission conducts unannounced surveys of hospitals on a regular basis with the goal of assessing structural attributes, policies, and staff to ensure patient safety and quality of care. The Department of Health and Human Services and the Center for Medicare and Medicaid Services recognizes The Joint Commission’s accreditation as deeming hospitals, laboratories, and other medical care providers able to participate in Medicare and Medicaid programs. (749)
Preventing Wrong-Site Surgery
23. By definition, wrong-site surgery involves all surgical procedures performed on the wrong patient, wrong body part, wrong side of the body, or the wrong level of a correctly identified anatomic site. This includes anesthesia procedures such as regional or neuraxial blocks. (749)
24. According to The Joint Commission, the reports of wrong-site surgery or procedures are steadily increasing. The actual incidence of wrong-site surgery is unknown but is estimated to be 1:15,000 to 1:112,000. (749)
25. To prevent the occurrence of wrong-site surgery, The Joint Commission has issued a universal protocol which requires:
26. The process of “time-out” is when all the services involved in caring for the patient (surgery, anesthesiology, and nursing) pause before beginning a procedure to ensure that the correct patient is undergoing the correct procedure on the correct location and all the necessary imaging studies and equipment necessary to safely complete the procedure are available. The essential elements for a preprocedural “time-out” are:
Improved Patient Identification
27. National Patient Safety Goals have focused on improving patient identification by checking two independent identifiers, such as name and date of birth or name and medical record number. (750)
28. These patient identifiers must be checked every time a patient is to undergo a diagnostic test or procedure, or is to receive medication or blood products. (750)
Improved Communication
29. When a patient is transferred from the care of one practitioner to another, whether it is from floor nurse to the anesthesiologist in the operating room, anesthesiologist to postanesthesia care unit nurse, or within services from daytime team to an on-call team, structured systems to facilitate the transfer of vital patient information are essential to avoid errors. The Joint Commission has termed these transfers of patient care as “handoffs.” (750)
30. Originally developed for U.S. Navy communications, situation-background-assessment-recommendation (SBAR) has been adapted by many health care organizations and is internationally accepted as an effective communication regarding a change in a patient’s condition either from nurse to physician or among physicians. The elements of SBAR communication are:
Medication Safety
31. Medication reconciliation refers to the process by which the medications the patient is on preoperatively are reviewed for any possible adverse reactions with any medications he or she might receive intraoperatively or postoperatively. (750)
32. Medication reconciliation should occur whenever the patient is admitted, transferred to another unit or service, or is discharged home. (750)
33. Medications should not be drawn into syringes until immediately prior to patient use and the syringes must be labeled with the drug name, drug concentration, and time medication is drawn up. Anesthesiologists have long adopted the use of color-coded labels to distinguish among different classes of medications in an effort to avoid medication administration errors. (750)
34. The Joint Commission recommends against the labeling of empty syringes in anticipation of future medication preparation since this does not obviate drawing the incorrect medication into a differently labeled syringe. A clarification on this recommendation was sought by the ASA, in response to which The Joint Commission will remove it from the FAQ section of their website. However, they have stopped short of a clear statement of reversing it. (750)
35. Additional requirements in ensuring medication safety are avoiding the use of abbreviations with regard to drug name and unit of dose. The use of decimal points followed by a trailing zero is also to be avoided while a zero must be placed in front of a decimal point to avoid dosing errors. Finally, the Do Not Use List prohibits the use of “u” for units, “iu” for international units, and Q.D. or Q.O.D. for daily or every other day dosing. (751)
36. Care must be taken to avoid using vials of drugs from manufacturers that look alike. If look-alike drugs cannot be avoided, such vials should not be placed near one another in any pharmacy drawer. In addition, TALLman lettering, such as EPInephrine may be used to distinguish it from EPHedrine. (751)
Fire safety
37. For a fire to start, each element of the fire triangle—heat, fuel, and oxygen—must be present. Heat is the by-product of electrocautery units, lasers, and endoscopes. Paper drapes, fabric towels, and gauze sponges provide ample fuel. Oxygen is often present at high concentrations in localized areas such as during facial plastic surgery or tracheostomy. Also, the newer, more effective skin preparation solutions often contain alcohol that is highly flammable and must be allowed to dry completely prior to placement of surgical drapes. (751)
38. Effective communication between all perioperative team members is essential in preventing OR fires. Skin preparation solutions must be completely dried prior to surgical draping, and lasers and endoscopes should be turned off or to standby when not in use. When there is a possibility that oxygen may come into direct contact with electrocautery, as in airway surgery or when administering oxygen in a non-closed circuit, oxygen should be administered at the lowest possible concentrations necessary for the patient to maintain oxygenation. Use of special endotracheal tubes may also be warranted in some cases. (751)
Reducing hospital-acquired infection
39. Prevention of hospital-acquired infections requires strict adherence to hand hygiene protocols, prevention of central line, and surgical site infections, and prevention against the spread of multidrug resistant organisms. Interventions by anesthesia providers may include appropriate selection of antibiotics, timely administration and dosing of antibiotics, proper hygiene and sterile technique where indicated, appropriate contact and respiratory precautions, and maintenance of normothermia. (751)
Surgical Care Improvement Project
40. The Surgical Care Improvement Project (SCIP) is a national partnership of organizations interested in improving surgical care by significantly reducing surgical complications. The steering committee is comprised of 10 national organizations who have pledged their commitment and full support for SCIP:
41. Current SCIP quality measures include the following evidence-based outcome improvement interventions:
Never Events
42. Never events are 28 occurrences on a list of inexcusable outcomes in a health care setting compiled by the National Quality Forum (NQF). They are defined as adverse events that are “serious, largely preventable, and of concern to both the public and health care providers for the purpose of public accountability.” The Centers for Medicare & Medicaid Services (CMS) also provides a list of never events, some of which coincide with the NQF. (752)
43. Per CMS, the list of never events includes:
44. If a never event occurs, CMS will not pay the hospital for the added cost of the extra care incurred as a result. (752)
Culture of Safety
45. A culture of safety enables any member of the health care team to contribute to patient safety. It is a key component of many high reliability organizations. Components of a culture of safety include:
High Reliability Organizations
46. High reliability organizations refers to organizations or systems that operate in hazardous conditions and have done so with nearly failure-free performance records, not simply better than average. Commonly discussed examples include air traffic control systems, nuclear power plants, and naval aircraft carriers. (753)
47. Compliance with patient safety initiatives involves either voluntary or mandatory reporting of adverse events. Reporting requirements are different in each state and for federal government programs as well. In 2002 Pennsylvania became the first state to establish a mandatory reporting system for not only serious adverse events, but “incidents” (near misses) as well. (753)
Operating room efficiency
48. Anesthesiologists can be leaders in facilitating punctuality, on time starts, keeping turnaround times between cases to a minimum, and promoting expeditious surgery to improve the utilization of resources in the operating room. A systems approach and standardization of equipment and processes will not only streamline operations and improve efficiency but also improve patient safety, staff satisfaction, and patient satisfaction. (753)
49. The operating rooms are the most expensive units to run in a hospital and, if run inefficiently, can become a major financial drain. However, when run appropriately, ORs are also the best source of revenue for most hospitals. (753)
Patient and staff satisfaction
50. Surveys have tracked a close link between staff satisfaction and patient satisfaction at health care facilities. For example, according to the National Surveys (Press Ganey), about one third of patients surveyed would not recommend the facility where they received care. Interestingly, about one third of health care employees at the hospitals surveyed were dissatisfied with their job. It should therefore be a goal for every facility to promote staff satisfaction and be intolerant of disruptive behavior so that the safest and best care is rendered to its patients. (753)