Lesson from Denver: Look Beyond Blaming Individuals for Errors

The "jury is in" on the case of the nurse charged with criminally negligent homicide in an infant’s death from a medication error. After about 45 minutes of deliberation, the jury not only acquitted the nurse, but the jurors also offered their support, crying and hugging the nurse after the verdict was delivered. Two other nurses indicted in this case accepted a deferred guilty plea prior to trial, in part, because they were afraid that a jury would render a single verdict for all three of them. The two nurses believed that they had a more prominent role in the medication error, and they did not want the third nurse found guilty by association when her role in the error was negligible.

Despite community pressure for individual accountability, the hospital where the error occurred provided significant support to all three nurses involved in the medication error. The nurse standing trial remained employed throughout the trial and continues to work in the newborn nursery. One of the other nurses lost her license to practice for one year, but the hospital continued to employ her as a unit secretary until she could again work as a nurse. The hospital and medical staff rallied in support of the individuals involved in the medication error, recognizing that errors belong to the system, not just individuals. In addition, the hospital provided the funds for all the nurses’ defense since, typically, professional liability insurance does not cover expenses for criminal charges. With this visible show of support, the hospital has taken a giant step forward to create the environment necessary to make significant changes in medication error prevention.

Along with others who donated their time to support this case, ISMP provided a systems analysis and expert testimony at trial. We identified over 50 different
failures in the system that allowed this error to occur, go undetected, and, ultimately, reach a healthy newborn child, causing his death. Had even just one of these failures not occurred, either the accident would not have happened, or the error would have been detected and corrected before reaching the infant. Since most of what people do is governed by the system, the causes of errors belong to the system and, consequently, often lie outside the control of individuals, despite their best efforts. This case provides clear evidence that medication errors are almost never caused by the failure of a single element or the fault of a single practitioner. Rather, a catastrophic event such as this is the result of the combined effects of “latent failures” in the system and “ active failures” by individuals.¹

Latent failures are weaknesses in the structure of an organization, such as faulty information management or ineffective personnel training, that result from both good and ill-conceived decisions made by upper management. By themselves, latent failures are often subtle and may cause no problems. Their consequences are hidden, becoming apparent only when they occur in proper sequence and combine with active failures of individuals to penetrate or bypass the system’s safety nets. Many of the latent and active failures that were at the root of this medication error are identified below. Providing an optimal level of medication safety requires that we recognize and correct the latent failures in the system. We must look beyond blaming individuals and focus on the multiple underlying system failures which shape individual behavior and create the conditions under which medication errors occur. And by their verdict, this is the lesson that the Denver jury wants us to learn.

A case riddled with latent and active failures

We have briefly discussed the Denver case in other issues, but now that the trial has concluded, we can present the many latent failures (underlined) and active failures (italics) that occurred. This is a good exercise in identifying failures that may be present in your institution. If failures are found, we recommend bringing them up at your pharmacy and therapeutics committee for evaluation.

An infant was born to a mother with a prior history of syphilis. Despite having incomplete patient information about the mother’s past treatment for syphilis and the current status of both the mother and child, a decision was made to treat the infant for congenital syphilis. After phone consultation with infectious disease specialists and the health department, an order was written for one dose of “Benzathine penicillin G 150,000U IM.”

The physicians, nurses and pharmacists, unfamiliar with the treatment of congenital syphilis, also had limited knowledge about this nonformulary drug. The pharmacist consulted both the infant’s progress notes and Drug Facts and Comparisons to determine the usual dose of penicillin G benzathine for an infant. However, she misread the dose in both sources as 500,000 units/kg, a typical adult dose, instead of 50,000 units/kg. Consequently, the pharmacist also incorrectly read and prepared the order as 1,500,000 units, a ten-fold overdose. Due to a lack of a consistent pharmacy procedure for independent double checking, the error was not detected. Since a unit dose system was not used in the nursery, the pharmacy dispensed the tenfold  overdose in a plastic bag containing two full syringes of PermapenÒ1.2 million units/2 mL each, with green stickers on the plungers to "note dosage strength." A pharmacy label on the bag indicated that 2.5 mL of medication was to be administered IM to equal a dose of 1,500,000 units.

After glancing at the medication sent from the pharmacy, the infant’s primary care nurse expressed concern to her colleagues about the number of injections required to give the infant the medication (since there is a maximum of 0.5 mL per IM injection allowed in infants, the dose would require five injections). Anxious to prevent any unnecessary pain to the infant, two colleagues—an advanced level staff nursery RN and a neonatal nurse practitioner — decided to investigate the possibility of administering the medication IV instead of IM.

Neofax ’95 was one of the medication resources relied upon by the two nurses to determine if penicillin G benzathine could be administered IV. The Neofax monograph on penicillin G did not specifically mention penicillin G benzathine; instead, it noted the treatment for congenital syphilis with aqueous crystalline penicillin G IV slow push or penicillin G procaine IM. Nowhere in the two page monograph was penicillin G benzathine mentioned, and no specific warnings regarding "IM use only" for penicillin G procaine and penicillin G benzathine were present.

Unfamiliar with the various forms of penicillin G, the nurse practitioner believed that "benzathine" was a brand name for penicillin G. This misconception was reinforced by the physician’s method of writing the drug order, written with benzathine capitalized and placed on a line above “penicillin G” rather than after it on the same line. In addition, many texts use ambiguous synonyms when referring to various forms of penicillin. For example, penicillin G benzathine is frequently associated with the terms “crystalline penicillin” and “aqueous suspension” in texts. Believing that aqueous crystalline penicillin G and penicillin G benzathine were the same drug, the nurse practitioner concluded that the drug could be safely administered IV. The nurses knew that, while taught that only clear liquids can be injected IV, certain milky white substances, such as IV lipids and other lipid-based drug products, can be given IV. Therefore, they did not recognize the problem of giving penicillin G benzathine, a milky white substance, intravenously.

Hospital policies and practices did not clearly define the prescriptive authority of non-physicians. However, the neonatal nurse practitioner was under the assumption that she was operating under a national protocol which allows neonatal nurse practitioners to plan, direct, implement and change drug therapy. Consequently, the nurse practitioner made a decision to administer the drug IV. The primary care nurse, who was not certified to administer IV medications to infants, transferred care of the infant to the advanced level staff nursery RN and the nurse practitioner.

While preparing for drug administration, neither nurse noticed the tenfold overdose, and neither noticed that the syringe was labeled by the manufacturer "IM use only." The manufacturer’s warning is very difficult to see because it is not prominently placed, and the syringe must be rotated 180° away from the drug name to view it. The nurses began to administer the first syringe of Permapen slow IV push. After about 1.8 mL was administered, the infant became unresponsive, and resuscitation efforts were unsuccessful.

References

1. Reason, J. The contribution of latent human failures to the breakdown of complex systems. Philosophical Transactions of the Royal Society of London B, 1990; 327, 475-484.