Physician anesthesiologist at Stanford at Associated Anesthesiologists Medical Group
Richard Novak, MD is a Stanford physician board certified in anesthesiology and internal medicine.Dr. Novak is an Adjunct Clinical Professor in the Department of Anesthesiology, Perioperative and Pain Medicine at Stanford University, the Medical Director at Waverley Surgery Center in Palo Alto, California, and a member of the Associated Anesthesiologists Medical Group in Palo Alto, California.
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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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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. 
  8. 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.
  9. 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
  10. 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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Physician anesthesiologist at Stanford at Associated Anesthesiologists Medical Group
Richard Novak, MD is a Stanford physician board certified in anesthesiology and internal medicine.Dr. Novak is an Adjunct Clinical Professor in the Department of Anesthesiology, Perioperative and Pain Medicine at Stanford University, the Medical Director at Waverley Surgery Center in Palo Alto, California, and a member of the Associated Anesthesiologists Medical Group in Palo Alto, California.

Clinical Case for Discussion:    You are the Medical Director of a freestanding surgery center.  A surgeon at the facility has a serious perioperative complication which leads to a bad outcome.  You believe that his management was below the standard of care.  What do you do?

Discussion:    You put on your best Dirty Harry sneer and say, “Punk, we don’t want your kind in these parts no more.”  Then you wake up from your daydream, and deal with the reality of an unpleasant responsibility.  Playing policeman with your surgical colleague’s privileges is not on any anesthesiologist’s Top Ten list.

There is a growing trend of surgical cases moving away from hospitals to freestanding facilities.   Each of these outposts must have medical leadership.  Anesthesiologists are ideally suited for Medical Director jobs, because of their training and expertise in perioperative patient care.  In addition, duties include quality assurance (QA) monitoring, setting policies and procedures, preoperative consultation regarding appropriateness of particular patients for the facility, and medical staff credentialing.

The phrase “Standard of Care” is defined as “the level at which an ordinary, prudent professional having the same training and experience in good standing in a same or similar community would practice under the same or similar circumstances.”  When a physician is suspected of practicing below the standard of care, the facility he or she is practicing at may initiate an investigation of his or her clinical practice.  In addition, if there was an adverse patient outcome, the medical malpractice system may initiate legal action to investigate the physician’s role in the adverse outcome.

This column will discuss only the investigation of the physician by the medical facility, and will not address the workings of the medical malpractice system.

When an adverse patient outcome occurs, the QA system at a surgery center begins with telephone calls to the Medical Director to inform him or her of the event, followed by written incident reports to document the details of what occurred.  The Medical Director is responsible for screening for:

(1) errors in the system which contributed to the patient’s outcome,

(2) errors in judgment, or

(3) practice below the standard of care.

Goals are to:

a)  improve any system problem which lead to the complication,

b)  identify  educational opportunities to prevent future incidents, and

c) identify if an individual may have practiced below the standard of care.  The medical-legal system defines standard of care as what a reasonably competent practitioner of that specialty would do in the same setting.

What will you do as Medical Director if after careful review of the medical records and incident reports, you believe the surgeon’s management was below the standard of care?   Each facility you work at, including a hospital or any surgery center, has a document called the Medical Staff Bylaws.  Most physicians throw their copy into a file cabinet and never read it.  In a case like we are examining today, the Bylaws are the road map for what to do next.  A typical Bylaw pathway might be as follows:   (Reference:  Bylaws of the Waverley Surgery Center in Palo Alto, California.)

(1) Investigation.  The QA committee, with representatives of all specialties, reviews the case.   (At  different institutions, this committee may have  a different name,  such as the Medical Advisory Committee, or the Medical Care Evaluation Committee.)   They may appoint an Ad Hoc Investigation Committee of relevant specialties to gather facts and circumstances.  The Investigation Committee will report back to the QA committee with their consensus.

(2) Interview.  The physician is interviewed by the QA committee.

(3) Actions.  The QA committee may:   a) take no action,  b) issue a warning,  c) recommend a term of probation,  d) recommend a reduction or suspension of privileges, or  e) recommend suspension or revoking of medical staff membership.

(4) Request for a hearing.  The physician may appeal and request a hearing following suspension or revoking of privileges.  An Ad Hoc Hearing Committee composed of unbiased members of the medical staff not previously involved in the investigation is chosen.  The physician is physically present for the hearing, and may have an attorney present.  The meeting is tape recorded, and all evidence is heard.  The majority decision of the Hearing Committee is usually final.  A system for appeals exists.

(5) Any suspension or revocation of privileges must be reported to the Medical Board of California, and the National Practitioner Data Bank.  Being reported to these two is a very big deal.  In the surgeon’s future, every application to every hospital or surgery center, and every medical license renewal would have to include this information.

Despite the obvious perks of stretch limousines, penthouse suites, and groupies,  the Medical Director job comes with some serious responsibilities.  Investigating another physician’s practice is difficult, time-consuming, and can be emotionally taxing for everyone involved.  Ignoring potentially substandard care is a mistake, however, that can result in further mishaps and the possibility of further patient harm in the future.

Dirty Harry exists for doctors too, but it is a system, not an individual, that does the dirty work. The Quality Assurance investigative system is a chore and and obligation for a Medical Director, but it’s an important and essential chore.



Published in September 2017:  The second edition of THE DOCTOR AND MR. DYLAN, Dr. Novak’s debut novel, a medical-legal mystery which blends the science and practice of anesthesiology with unforgettable characters, a page-turning plot, and the legacy of Nobel Prize winner Bob Dylan.


In this debut thriller, tragedies strike an anesthesiologist as he tries to start a new life with his son.

Dr. Nico Antone, an anesthesiologist at Stanford University, is married to Alexandra, a high-powered real estate agent obsessed with money. Their son, Johnny, an 11th-grader with immense potential, struggles to get the grades he’ll need to attend an Ivy League college. After a screaming match with Alexandra, Nico moves himself and Johnny from Palo Alto, California, to his frozen childhood home of Hibbing, Minnesota. The move should help Johnny improve his grades and thus seem more attractive to universities, but Nico loves the freedom from his wife, too. Hibbing also happens to be the hometown of music icon Bob Dylan. Joining the hospital staff, Nico runs afoul of a grouchy nurse anesthetist calling himself Bobby Dylan, who plays Dylan songs twice a week in a bar called Heaven’s Door. As Nico and Johnny settle in, their lives turn around; they even start dating the gorgeous mother/daughter pair of Lena and Echo Johnson. However, when Johnny accidentally impregnates Echo, the lives of the Hibbing transplants start to implode. In true page-turner fashion, first-time novelist Novak gets started by killing soulless Alexandra, which accelerates the downfall of his underdog protagonist now accused of murder. Dialogue is pitch-perfect, and the insults hurled between Nico and his wife are as hilarious as they are hurtful: “Are you my husband, Nico? Or my dependent?” The author’s medical expertise proves central to the plot, and there are a few grisly moments, as when “dark blood percolated” from a patient’s nostrils “like coffee grounds.” Bob Dylan details add quirkiness to what might otherwise be a chilly revenge tale; we’re told, for instance, that Dylan taught “every singer with a less-than-perfect voice…how to sneer and twist off syllables.” Courtroom scenes toward the end crackle with energy, though one scene involving a snowmobile ties up a certain plot thread too neatly. By the end, Nico has rolled with a great many punches.

Nuanced characterization and crafty details help this debut soar.

Click on the image below to reach the Amazon link to The Doctor and Mr. Dylan:


Learn more about Rick Novak’s fiction writing at ricknovak.com by clicking on the picture below: