Tag ampoule swap

QUALITY ASSURANCE IN ANESTHESIA

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THE ANESTHESIA CONSULTANT
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.
emailrjnov@yahoo.com
Latest posts by THE ANESTHESIA CONSULTANT (see all)
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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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The most popular posts for laypeople on The Anesthesia Consultant include:
How Long Will It Take To Wake Up From General Anesthesia?
Why Did Take Me So Long To Wake From General Anesthesia?
Will I Have a Breathing Tube During Anesthesia?
What Are the Common Anesthesia Medications?
How Safe is Anesthesia in the 21st Century?
Will I Be Nauseated After General Anesthesia?
What Are the Anesthesia Risks For Children?
The most popular posts for anesthesia professionals on The Anesthesia Consultant  include:
10 Trends for the Future of Anesthesia
Should You Cancel Anesthesia for a Potassium Level of 3.6?
12 Important Things to Know as You Near the End of Your Anesthesia Training
Should You Cancel Surgery For a Blood Pressure = 178/108?
Advice For Passing the Anesthesia Oral Board Exams
What Personal Characteristics are Necessary to Become a Successful Anesthesiologist?

LEARN MORE ABOUT RICK NOVAK’S FICTION WRITING AT RICK NOVAK.COM.

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SEVEN DEADLY DRUGS IN AN ANESTHESIOLOGIST’S DRAWER

THE ANESTHESIA CONSULTANT 2 Comments
THE ANESTHESIA CONSULTANT
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.
emailrjnov@yahoo.com
Latest posts by THE ANESTHESIA CONSULTANT (see all)

As anesthesiologists we are the only physicians who routinely prescribe and administer injectable medications ourselves. Most physicians write orders for medications. Registered nurses then administer the medications on hospital wards, in intensive care units, in emergency rooms, and in clinics. As anesthesiologists we have our own drug cart, stocked with dozens of medications, including hypnotics, paralyzing drugs, cardiovascular drugs, antibiotics, anti-nausea drugs, anti-inflammatory drugs, and resuscitation drugs. There are Seven Deadly Drugs in an anesthesiologist’s drawer.

drug ampoules in an anesthesia drawer

Typically, we make a decision to inject a drug, then open the ampoule, draw the contents of the ampoule into a syringe, and inject it into the patient … without the approval, input, or monitoring of any other healthcare provider.

Do medication errors occur? Yes they do, because anesthesiologists are human, and to err is human. In a survey conducted in Japan between 1999 and 2002 in more than 4,291,925 cases, the incidence of critical incidents due to drug administration error was 18.27/100,000 anesthetics. Cardiac arrest occurred in 2.21 patients per 100,000 anesthetics. Causes of death were overdose or selection error involving non-anesthetic drugs, 47.4%; overdose of anesthetics, 26.3%; inadvertent high spinal anesthesia, 15.8%; and local anesthetic intoxication, 5.3%. Ampoule or syringe swap did not lead to any fatalities. (Irita K, et al. Critical incidents due to drug administration error in the operating room: an analysis of 4,291,925 anesthetics over a 4 year period. Masui 2004; 53(5):577–84. )

In a South African study of 30,412 anaesthetics, anaesthetists reported a combined incidence of one error or near-miss per 274 cases. Of all errors, 36.9% were due to drug ampoule misidentification; of these, the majority (64.4%) were due to similar looking ampoules. Another 21.3% were due to syringe identification errors. No major complication attributable to a drug administration error was reported. (Llewellyn RL, et al. Drug administration errors: a prospective survey from three South African teaching hospitals. Anaesth Intensive Care 2009 ; 37(1):93–8. )

What can be done to eliminate or minimize medication errors? A Japanese study examined the value of color-coding syringes, as follows: blue syringes contained local anesthetics; yellow syringes, sympathomimetic drugs; and white-syringes with a red label fixed opposite the scale, muscle relaxants. Although five syringe swaps were recorded from February 2003 to January 2004 in 5901 procedures prior to the change, they encountered no syringe swaps from February 2004 to January 2005 in 6078 procedures performed after switching to color-coded syringes (P <0.05). (Hirabayashi Y, et al. The effect of colored syringes and a colored sheet on the incidence of syringe swaps during anesthetic management. Masui 2005; 54(9):1060–2.)

Published evidence-based practices to reduce the risk of medication error include the following recommendations:

  1. The label on any drug ampoule or syringe should be read carefully before a drug is drawn up or injected;
  2. The legibility and contents of labels on ampoules and syringes should be optimized according to agreed standards; syringes should always be labeled; formal organization of drug drawers and workspaces should be used;
  3. Labels should be checked with a second person or a device before a drug is drawn up or administered. (Note: this is impractical in the anesthesia world.)
  4. Dosage errors are particularly common in pediatric patients. Technological innovations, including the use of bar codes and various cognitive aids, may facilitate compliance with these recommendations. (Merry AF, Anderson BJ. Medication errors–new approaches to prevention. Paediatr Anaesth 2011; 21(7):743–53.)

Bar-code medication administration (BCMA) systems exist for anesthesiologists to identify the ampoule of each drug at the time of administration. I’m not seeing these devices in widespread use in the United States yet. A pilot study in Great Britain perceived that bar-code readers contributed to the prevention of drug errors. The study concluded that the  technological aspects of its integration into the operating theatre environment, and learning, will require further attention. (Evley R. Confirming the drugs administered during anaesthesia: a feasibility study in the pilot National Health Service sites, UK. Br J Anaesth 2010; 105(3):289–96.)

In addition to the data from the aforementioned publications on the incidences of medication errors, how many medication errors go unpublished and unreported? Many anesthesiologists I know have shared their tales of medication errors, all of which are unpublished and unreported in the medical literature. Some swaps and errors will be inconsequential. Some swaps and errors will prolong an anesthetic, such as when a muscle relaxant paralyzes a patient at an unintended time or dose. Some swaps and errors contain the potential for dire complications.

The ancient Christian world identified Seven Deadly Sins. They were wrath, greed, sloth, pride, lust, envy, and gluttony. There exist at least seven medications that an anesthesiologist must strive to never inject intravenously in error. I call these the Seven Deadly Drugs.  All are present in the anesthesiologists’ drug drawer or at the operating room pharmacy. They are as follows:

  1. Epinephrine (1mg/1ml ampoule). Epinephrine is an important drug during ACLS to treat asystole and refractory ventricular fibrillation, to treat anaphylaxis, or to be used as an infusion to treat decreased cardiac output. This ampoule is routinely stocked in most drug drawers. If one injects it in error into a healthy patient, major hypertension and tachycardia will ensue.  Think blood pressures in the 250/150 range, and heart rates approaching 200 beats per minute. This can be lethal in elderly patients, or in patients with diminished cardiac reserve.
  2. Phenylephrine (10 mg/1 ml ampoule). Phenylephrine, when injected in 100-microgram doses or used as a dilute infusion, is an important drug to treat hypotension. This ampoule is routinely stocked in most drug drawers. If one injects it in error into a healthy patient, major hypertension will ensue, as well as reflex bradycardia.  Think blood pressures in the 250/150 range, and heart rates dropping below 50 beats per minute. This can be lethal in elderly patients, or patients with diminished cardiac reserve.
  3. Nitroprusside (50 mg/2ml) Nitroprusside, when diluted into an infusion, is an important drug to treat hypertension. If this ampoule is injected undiluted, the patient will experience rapid arterial vasodilation and severe hypotension.
  4. Insulin (100 Units/1ml, 10 ml vial). Insulin is an important medication to treat hyperglycemia. Typical doses range from 5–30 Units, which is a mere 1/20th to 3/10th of one milliliter. An erroneous injection of an insulin overdose to an anesthetized patient can result in severe hypoglycemia and brain death.
  5. Potassium Chloride (20 Meq/10 ml). Potassium chloride is an important treatment for hypokalemic patients. If it is administered erroneously as a bolus, potassium chloride can cause severe ventricular arrhythmias and death.
  6. Heparin (1000 U/ml). Heparin is an important anticoagulant, used routinely in open heart surgery and vascular surgery. If it is administered in error, it can cause unexpected bleeding during surgery.
  7. Isoproterenol (1 mg/5 ml) Isoproterenol can be used as a dilute infusion to increase heart rate in critically ill patients.  One of the hospitals I work at includes an ampoule of isoproterenol in the routine drug drawer, next to ampoules of common medications such as ketorolac (Toradol), hydrocortisone, and promethazine (Phenergan). If one injects a bolus of isoproterenol in error into a healthy patient, major tachycardia and hypertension will ensue. This can be lethal in elderly patients, or patients with diminished cardiac reserve.

What can anesthesiologists do to eliminate the risks of erroneously bolus injecting the Seven Deadly Drugs? This author recommends elimination of major vasopressor drugs such as epinephrine, phenylephrine, and isoproterenol and major vasodilators such as nitroprusside from routine drug drawers. This author recommends elimination of the potent anticoagulant heparin from routine drug drawers. Insulin is routinely sequestered in an operating room refrigerator, and most hospitals have protocols that insulin doses be double-checked by two medical professionals prior to injection. Potassium chloride is routinely sequestered the operating room pharmacy as well, distanced from the anesthesiologist’s routine drug drawer.

Above all, anesthesia practitioners need to be vigilant of the risk of picking up the wrong drug ampoule in error. Read the labels of your ampoules carefully, and take care not to inject any of the Deadly Seven Drugs.

 

The most popular posts for laypeople on The Anesthesia Consultant include:

How Long Will It Take To Wake Up From General Anesthesia?

Why Did Take Me So Long To Wake From General Anesthesia?

Will I Have a Breathing Tube During Anesthesia?

What Are the Common Anesthesia Medications?

How Safe is Anesthesia in the 21st Century?

Will I Be Nauseated After General Anesthesia?

What Are the Anesthesia Risks For Children?

 

The most popular posts for anesthesia professionals on The Anesthesia Consultant  include:

10 Trends for the Future of Anesthesia

Should You Cancel Anesthesia for a Potassium Level of 3.6?

12 Important Things to Know as You Near the End of Your Anesthesia Training

Should You Cancel Surgery For a Blood Pressure = 178/108?

Advice For Passing the Anesthesia Oral Board Exams

What Personal Characteristics are Necessary to Become a Successful Anesthesiologist?

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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.

KIRKUS REVIEW

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:

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

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