Case study #2020: A healthy 48-year-old woman is anesthetized for a hysterectomy. As the surgery is ending, her blood pressure skyrockets to 220/160 and her pulse rate rises to 165 beats per minute. She is resuscitated and transferred to the Intensive Care Unit (ICU).
What happened? The hospital’s Quality Assurance (QA) program, also known as a Quality Improvement (QI) program, is charged with investigating this adverse event.
Mistakes happen in medicine.
In 1999 the Institute of Medicine published the landmark “To Err is Human” report, which described that adverse events occurred in 3 – 4% of all hospital admissions, and that over 50% of the adverse events were due to preventable medical errors. Approximately 10% of the adverse events led to deaths. The report estimated that 44,000 – 98,000 Americans died each year due to medical errors. The report estimated that medical errors were the 8th leading cause of death in the United States. The report recommended that instead of blaming individuals, to instead prevent future errors by designing safety into the system.
My experience in Quality assurance/Quality improvement programs includes:
- Stanford University Hospital QA Committee (Care Review Committee), 1997 – 2009
- Stanford University Anesthesia QA Committee, 2002 – 2009, and
- Waverley Surgery Center QI Committee (Chairman), 2002 – present.
The analysis of complications is one of the most interesting aspects of medicine. Every complication has an opening event, a story line, and a conclusion. Using Case study #2020 above, let’s trace through the steps involved in improving medical quality:
- CAPTURE THE CASES. The first task is to find out about all adverse events. This can be harder than it sounds. Ideally the involved MDs and nurses will fill out an Incident Report or an Adverse Event Report, which includes the details of what happened to their patient. But many clinicians are reluctant to hang out their dirty laundry, and it’s possible for adverse events to be hidden, buried, or ignored. This hampers care improvement. We can’t fix problems we haven’t identified. At a large hospital, Adverse Event Reports are digitally entered into a computer site. At a smaller facility such as a surgery center, Adverse Event Reports are filed on paper forms. In either case, once the case is captured, the QA system can analyze the event. Case study #2020: The attending surgeon and the operating room nurse each filed digital Adverse Event documents because of their patient’s extremely high blood pressure and heart rate, and her unplanned admission to the ICU.
- ANALYZE ADVERSE INCIDENT REPORTS FOR SIGNIFICANT NEGATIVE CLINICAL OUTCOMES, OR THE NEAR MISS OF A NEGATIVE OUTCOME. Some Adverse Events reports are more significant than others. Some reports reveal only minor issues such as prolonged post-operative nausea and vomiting, or a prolonged Post Anesthesia Care Unit stay. An MD or specially trained RN will sift through the stack of Adverse Event Reports and choose those problems which require attention. Case study #2020: The chairperson of the QA Committee notes the elevated BP and heart rate and the unplanned ICU admission, and flags this case for immediate committee evaluation.
- ROOT CAUSE ANALYSIS . . . RETRIEVE AND REVIEW ALL RELEVANT MEDICAL RECORDS FOR COMMITTEE: Root Cause Analysis (RCA) is an organized approach to ferreting out the causes for any adverse medical event. The goal of RCA is to find out what happened, why it happened, and what can be done to prevent it from happening again. After a hospital complication, all electronic medical records (EMRs) pertinent to the incident are reviewed to discern what happened. A time line is formulated, with the goal of finding a cause and effect relationship that led to the complication. The hospital EMR may be hundreds of pages long, depending on the complexity of the case. At an outpatient surgery center where medical records are usually kept on paper, the review process is faster and easier, as the entire case may be documented in twenty pertinent pages or less. Case #2020: Review of the case shows that the BP and heart rate increases occurred within minutes after the anesthesiologist administered an intravenous dose of the drug atropine.
- INTERVIEW THE CLINICIANS: Members of the committee are charged with interviewing the individuals present at the time of the complication. Case #2020: The surgeon, operating room nurse, and the anesthesiologist are interviewed. The initial interviews with the clinicians are done prior to the QA Committee meeting on the case, although key clinicians may be interviewed at the actual QA Committee meeting. The pertinent revelation was that the anesthesiologist administered an intravenous dose of 4 mg of Zofran, and charted that the dose was administered. After the case was over, he said he looked for the empty atropine ampoule, and discovered that it was instead an empty 1 mg epinephrine ampoule.
- ASSESS WHAT HAPPENED: In Case #2020: The unintended intravenous bolus injection of 1 mg of epinephrine into a stable patient caused life-threatening hypertension and elevated heart rate. Epinephrine is adrenaline, and a dose of 1 mg IV bolus is only appropriate if a patient is in cardiac arrest situation, such as ventricular fibrillation, asystole (flat line), or pulseless electrical activity. The administration of a wrong medicine by human error is called “syringe swap” or “ampoule swap.” It’s a preventable human error. In this case the atropine and epinephrine ampoules were nearly identical in size, color, and shape. The two different ampoules were stored in the same drawer in the anesthesiologist’s drug cart, and the distance between the two storage areas was only 2 inches.
- REVIEW THE RELEVANT MEDICAL LITERATURE: Using PUBMED.com, it’s easy to search for similar incidents in the medical literature. The committee found an example of the very same epinephrine ampoule swap occurring previously. In this published case report, an epinephrine ampoule was erroneously injected instead of a similar appearing neostigmine ampoule at the conclusion of a hysterectomy. The patient had an immediate cardiac arrest. The patient survived, but required an ICU stay. The neostigmine and adrenaline ampoules were very similar and were stored in adjacent compartments in the anesthesia cart.
- THE QA COMMITTEE DISCUSSES THE CASE: The committee consists of MDs from multiple specialties. Case #2020: These MDs discuss the case and the probable cause of the adverse event, and discuss possible system improvements to prevent repeat of the error in the future. These suggestions are based on the education, experience, and training of the committee members, as well as from input from the relevant medical literature. Note that the committee does not criticize or blame the anesthesiologist for making the error, and does not make a point of singling out the individual physician as the culprit.
- MAKE SYSTEM CHANGES TO AVOID FUTURE SIMILAR COMPLICATIONS: Case #2020: The committee decides to remove all 1 mg epinephrine ampoules from the readily accessible anesthesiologist drug drawers in all operating rooms, to prevent the inadvertent administration of another dangerous bolus of epinephrine when it could be mistaken for Zofran or any other drug. (Epinephrine is an important medication to be administered during cardiac arrests, allergic reactions, or for cardiac patients whose blood pressure is falling precipitously, so the medication must be available.) The committee recommends that the only formulation of epinephrine included in the anesthesia drug drawer be the clearly labeled cardiac arrest epinephrine bolus syringes, which are packaged in individual cardboard boxes. The dangerous 1-milliliter epinephrine ampoules are moved out of the operating room. The recommended policy and procedure is for anesthesiologists to request the 1-milliliter ampoules to be retrieved for them from pharmacy storage, by the operating room nurse, only when needed. This is expected to be a rare occurrence.
- SOME PEER REVIEW OUTCOMES REQUIRE REPORTING TO THE CALIFORNIA STATE MEDICAL BOARD: QA/QI work is part of peer review, and cannot be subpoenaed during any legal malpractice litigation. In California, a QA investigation triggers a obligated report to the state Medical Board when the following may have occurred: (A) Incompetence, or gross or repeated deviation from the standard of care involving death or serious bodily injury to one or more patients, to the extent or in such a manner as to be dangerous or injurious to any person or to the public; (B) The use, prescribing, or administration to himself or herself of any controlled substance, or the use of any dangerous drug or of alcoholic beverages, to the extent or in such a manner as to be dangerous or injurious to the licentiate, any other person, or the public, or to the extent that such use impairs the ability of the licentiate to practice safely; (C) Repeated acts of clearly excessive prescribing, furnishing, or administering of controlled substances or repeated acts of prescribing, dispensing, or furnishing of controlled substances without a good faith effort prior examination of the patient and medical reason therefor; or (D) Sexual misconduct with one or more patients during a course of treatment or an examination
- ONGOING METRICS ARE TRENDED TO TRACK CHANGES IN COMPLICATION RATES: The QA Committee must collect follow up data to determine if the suggested system change improved future outcomes. If the data indicates worsening trends, then the committee will investigate and consider further Quality Improvement measures. Case #2020: for two years following the new epinephrine policy there were zero ampoules swaps involving epinephrine. In addition, zero other episodes of ampoule swap of any other drugs occurred.
Mistakes happen. The role of a QA Committee is to prevent them from happening again. This method of making system changes so that Hazards are less likely to become Losses, is depicted in the Swiss Cheese model below:
The Swiss Cheese Model was originally designed to eliminate errors in the oil industry, and was later adopted by the airline industry. Visualize the pieces of Swiss Cheese as barriers between Hazards and Losses. Each single Swiss Cheese barrier isn’t perfect and isn’t sufficient to prevent a hazard. Each additional barrier is designed so that the error that penetrated through the first barrier is stopped by the second barrier. Designing different barriers at different stages of medical care, with different strengths and weaknesses, makes it more difficult for a Hazard (mistake) to lead to a Loss (serious injury or death). The Swiss Cheese model is designed to make it difficult for a straight line to exist from Hazard to Losses.
The Quality Assurance process is summarized in the article Overview of the Quality Assurance Movement in Health Care. Hospitals and surgery centers in your area are following Quality Assurance processes similar to those discussed above, so that when you or your loved ones are admitted for medical care, the chances of a serious complication will be as close to zero as possible.
Note: The Anesthesia Patient Safety Foundation (APSF) is the national organization that deals with safety issues in anesthesiology practice. The monthly APSF newsletters are available online at https://www.apsf.org, and serve as valuable educational material for every anesthesiologist regarding safety issues in our specialty.
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