October 30, 2017

Anesthesiology has a long history of improvements in patient safety, but anesthesia care providers know they can always do better.  As healthcare’s transition to value-based care continues and clinicians are held to increasingly high standards for quality and safety through MACRA’s Merit-Based Incentive Payment System (MIPS) and other programs, anesthesia practices might consider incorporating the innovative safety improvement methodologies of high reliability industries into their practices.

An anesthesia provider’s error in the operating room, followed by a massive overdose of insulin given intraoperatively to a child--and the family’s ensuing outrage—prompted a journey by Charles Dean Kurth, MD, of Children’s Hospital of Philadelphia (CHOP) to embed the values and practices of high reliability industries in the anesthesia drug delivery system at his institution.

An investigation by Dr. Kurth into why the medication error happened eventually led to a string of evidence-based changes in the OR, including implementation of a standardized drug tray, preparation of antibiotics and infusion pumps by pharmacy, and plans to introduce medication bar code scanning this year.

Over several meetings, in addition to reporting how and why the error occurred, Dr. Kurth was able to promise the family and 15-year-old patient (whose care following the overdose was effectively managed and who suffered no harm) that he would do his best to prevent insulin and other drug errors from occurring in other patients.  The anesthesia department’s embrace of a high reliability safety culture is helping to deliver on that promise.

In a presentation at ANESTHESIOLOGY^® 2017, Dr. Kurth, who is chair of anesthesiology and critical care medicine at CHOP, encouraged anesthesiologists and nurse anesthetists to adopt the same culture, principles and techniques to evaluate the anesthesia drug delivery systems at their facilities and pinpoint opportunities for change.

Dr. Kurth put forth a three-step process:

1. Understand the drug delivery system. 
2. Understand and define the patient safety problem related to the drug delivery system.
3. Understand and apply the quality improvement and high reliability principles that have been used successfully in many hospitals to fix defects in the anesthesia drug delivery system and make it safer.

Understand the Drug Delivery System.

To understand the drug delivery system at his institution, Dr. Kurth conducted a Failure Effect Mode Analysis (FEMA) of the processes associated with each of the “five rights” of drug delivery:  patient, drug, dose, route and time.  

The FEMA revealed major differences between the anesthesia drug delivery system in the OR and the drug delivery system the hospital was using for inpatient care.  While every step in the anesthesia system relied solely on one person—the anesthesiologist or nurse anesthetist—the hospital system used multiple people, technologies and double checks to protect against errors, including computerized physician order entry, robots and clinical decision support.

The hospital system was designed to perform tasks within an hour, but in anesthesia, the pace and dynamic nature of surgery requires a system that can perform within minutes.  Further, the hospital system distributes costs over hundreds of beds, but reproducing the inpatient system for the anesthesia drug delivery system in every OR is cost prohibitive.  “The anesthesia drug delivery system is going to be different.  It has to be,” Dr. Kurth said.  At CHOP, the question was how to incorporate some of the inpatient system’s safety features into the anesthesia system.

Understand and Define the Patient Safety Problem Related to the Drug Delivery System.

Dr. Kurth noted studies of anesthesia-related drug errors showing that a medication error associated with a serious adverse drug event (ADE) occurs in approximately one in 100 patients.  [A prospective observational study published in the January 2016 issue of Anesthesiology found that approximately 1 in 20 perioperative medication administrations, and every second operation, resulted in a medication error and/or an adverse drug event.  More than one third of these errors led to observed patient harm, and the remaining two thirds had the potential for patient harm.]

Studies across developed countries of drug errors based on a system that classifies errors according to incorrect dose, omission, repetition, substitution, insertion and incorrect route consistently show incorrect dose, substitution and omission to be the leading types of errors (90 percent) in anesthesia, with wrong dose the most common type of medication error in pediatric anesthesia.   

Dr. Kurth highlighted the work of The Children’s Hospitals Solutions for Patient Safety Network, which has decreased the rate of inpatient ADEs by 65 percent over five years.  However, Wake Up Safe, a national quality improvement initiative involving 31 pediatric anesthesia departments with a database of four million cases of anesthetics, reports a pediatric anesthesia ADE rate (approximately 0.15 per 1,000 anesthetics)—a rate that hasn’t changed in seven years.  “The children’s hospitals are giving the same number of drugs per day to their patients, but their ADE rate is one-tenth that of pediatric anesthesia.  What are they doing that we could be doing to improve drug safety?” said Dr. Kurth.

Understand and Apply High Reliability and Quality Improvement Principles.

What they are doing is using the principles of high reliability organizations and quality improvement science, which can also be used to fix faults in the anesthesia drug delivery system, he said.  One of the principles of quality improvement science is that something must be measured before it can be improved.  In anesthesia, that measurement must incorporate both automated trigger tools and the voluntary reporting of errors.  Voluntary reporting must be a focus because an electronic solution alone won’t capture everything.

Another tenet of quality improvement science is that there is no point in measuring something unless you intend to improve it.  Collecting statistics and educating clinical staff rarely lead to lasting improvement.  According to quality science pioneer W. Edwards Deming, improvement requires both subject matter knowledge (the anesthesia provider’s knowledge of pharmacology and physiology) and profound knowledge, which includes an appreciation of the system and change management.

“It’s important when you talk about quality improvement and making anesthesia drug delivery safer that you appreciate the system,” said Dr. Kurth, noting that anesthesia providers on the insulin overdose case were excellent clinicians.  “When there’s an error or ADE, don’t automatically go to the person.  You have to think about how that person is set up for that event to occur.” Dr. Kurth’s FEMA helped in this regard.

In addition, change management “is where the rubber hits the road,” he said.  “Deming recognized that if you talk about performance in any system in the absence of leadership, you don’t get change.”

Studies of high reliability industries such as aviation and nuclear power (Six Sigma industries with error rates of one per million or less) show that these organizations share five values in common: 

• Preoccupation with failure.  The people who work in these organizations are always thinking about what could go wrong.
• Reluctance to simplify interpretations.  When something is abnormal they don’t immediately write it off; they actually investigate it.
• Sensitivity to operations. Operations is king in high reliability organizations.
• Commitment to resilience.  They don’t give up easily. When something goes wrong, they stick with it.
• Deference to expertise.  Who knows the most about the problem you’re trying to solve?  “When you’re in the OR, how often is it that you ask ‘who knows the most about this’?  Often, we fall into these hierarchical or siloed structures where we assume if it’s a surgical problem the surgeon knows about it; if it’s an anesthesia problem, the anesthesiologist knows about it.  That may or may not be true.  High reliability organizations say it is impossible to prevent everything.  The world is too big and there are too many things we don’t know that can happen.  We have to focus on rescuing ourselves from the unpredictable.”

In a systematic review of 100 preventive strategies to improve drug safety in pediatric anesthesia published this year in the British Journal of Anaesthesia, the strategies most highly rated by a panel of 20 experts included a high reliability quality improvement culture; preprinted labels; a standardized drug tray; bar code scanning; syringes prepared by pharmacy; automated alerts for antibiotics; two-person double checks of drugs; and smart infusion pumps.

Although compliance is challenging, especially during fast cases, evidence indicates these strategies work.  A randomized trial involving 89 anesthesiologists, 1,000 cases and 10,000 drugs published in 2011 in the British Medical Journal showed a 50 percent error reduction when preventive strategies were used.  The strategies included a standardized drug tray, pharmacy delivery of drugs, prefilled syringes, colored labels, bar code scanning and use of the electronic medical record to give dose reminders.  Bar code scanning and the electronic dose reminders were responsible for 90 percent of the error reduction.

“We have opportunities to make our system safer than it currently is,” said Dr. Kurth.  “We believe we’re well on our way to having a high reliability reporting culture.  This is our aspiration and it could easily be yours.”  The anesthesia drug delivery system at CHOP now labels every drug with preprinted labels, uses a standardized drug tray and automated alerts for antibiotics; uses pharmacy to prepare antibiotics and infusion pumps; and plans to incorporate bar code scanning and infusion pump reconciliation processes in the near future.  “We want to be able to say to a patient that we’re as safe as we possibly can be,” he said.

Plexus Technology Group’s Pharmacy Touch™, a modular add-on to the Anesthesia Touch™ anesthesia information management system, offers barcode medication verification, color-coded syringe labeling and other capabilities to streamline medication management and reduce drug errors in the OR.  For more information, contact info@plexustg.com.  ABC clients: Please contact your account executive for information and assistance.

With best wishes,

Tony Mira
President and CEO