Another Heparin Error: Learning from Mistakes So We Don't Repeat Them

It’s been headline news for the past week: three infants at one of the most reputable hospitals in California received 1,000 times more heparin than intended when vials containing 10,000 units/mL instead of  10 units/mL were used in error to flush the infants’ vascular access lines. No doubt the intense media attention given to these errors is related to the fact that two of the infants are the newborn twins of Hollywood celebrities Dennis and Kimberly Quaid. Fortunately, according to news reports, none of the affected infants suffered lasting adverse effects from the error.

These events are remarkably similar to a case in Indiana last year that we described in our September 21, 2006 newsletter. In that case, three babies died after receiving overdoses of heparin while flushing their vascular access lines. According to news reports, in both the Indiana and California cases, pharmacy technicians accidentally placed vials containing more concentrated heparin (10,000 units/mL) in storage locations in patient care areas designated for less concentrated heparin vials (10 units/mL). Vials (both from Baxter, according to the media) containing the different strengths of heparin looked similar. Thus, the nurses—who were accustomed to finding only the 10 units/mL concentration of heparin in stock—did not notice the error until after the wrong concentration had been used to flush the infants’ access lines.

In response to the most recent error, the California hospital no longer stocks heparin 10 units/mL vials in pediatric units and uses saline to flush all neonatal, pediatric, and adult peripheral lines. No information was shared about flushing practices for central line catheters, including umbilical lines and PICC lines. In the pharmacy, 10,000 units/mL heparin vials have been separated from vials containing other strengths. In our September 2006 newsletter article, we made additional recommendations, which included: verifying all drugs pulled in the pharmacy for restocking in patient care units; using bar-coding to verify the drug and strength; and replacing heparin vials with prefilled syringes of heparin flush solutions. Low-dose heparin flush syringes are available from Hospira in 1 unit/mL (3 units/3 mL per 10 mL syringe) and 2 unit/mL (6 units/3 mL per 10 mL syringe) strengths.

Recently, Baxter revised the packaging and labeling on its 1,000 units/mL, 5,000 units/mL, and 10,000 units/mL heparin vials. Distribution of the newly labeled vials began in October. Unfortunately, vials with the old labels are still part of the inventory in many hospitals. If you currently stock Baxter’s 10 units/mL vials along with vials containing other concentrations, request products with the new labeling as soon as possible. Baxter representatives informed us that they are ramping up inventories and pursuing alternatives to accelerate manufacturing and distribution to meet anticipated needs.

A deeper analysis of these heparin errors underscores two fundamental problems in today’s healthcare industry that continue to threaten patient safety:

• Our failure to fully adopt a learning culture
• Our failure to be truly mindful about safety.

Learning culture. When viewed from the aggregate perspective of all healthcare provided to all patients, harmful errors might seem to occur frequently. In individual organizations, however, they occur infrequently. Therefore, the only way to make significant safety improvements and remain consistently mindful of patient safety is to seek out and learn from information about risk and errors from within the organization and externally.

Unfortunately, many organizations do not use external safety information from sources such as ISMP newsletters, The Joint Commission Sentinel Event Alert, FDA and USP advisories, and other reliable publications, to inform internal improvement efforts. If truth be told, it’s rare for healthcare organizations to systematically and effectively learn from the failures of others. In 2000 and 2004, ISMP distributed a medication safety self-assessment tool for hospitals. When asked if an interdisciplinary team uses published error experiences to improve medication safety, only 50% of more than 1,600 participating hospitals in 2004 (and 29% in 2000) said they consistently perform this important function. Because organizations want to be safe, they tend to look for evidence of safety, not hazards, and may not recognize the valuable gift that colleagues offer by sharing their stories of error and risk. Regulatory and accrediting agencies have tacitly endorsed this behavior by failing to require organizations to seek out and learn from the failures of others as a condition of accreditation or licensure.

Of all the elements of a culture of safety, a learning culture is probably the easiest to engineer and the hardest to make work.¹ In a learning culture, workers must possess the willingness and competence to draw responsible conclusions from robust internal and external safety information systems and make substantial changes when necessary. Too often, practitioners read published reports about harmful errors but do not truly believe the events could happen to them. Absent shared learning, the same heparin error will likely occur in other hospitals.

Mindfulness. The healthcare industry has not sufficiently developed a healthy preoccupation with system failures to counteract the usual sense of comfort that stems from success. Instead of harboring a chronic worry about system failure, healthcare workers have become complacent and are not always thinking critically about patient safety. Prime examples include the misguided “no news is good news” viewpoint in organizations that have not yet experienced a tragic medical error, and discourses that simply chastise organizations when an error happens, without offering a thoughtful analysis of the event and practical recommendations to prevent reoccurrence. Each organization needs to proactively identify risks, appreciate how susceptible its systems are to the same errors that have happened in other organizations, and acknowledge that the absence of similar errors is not necessarily evidence of success.

As 2007 draws to a close, ISMP encourages you to make it your professional New Year’s resolution to seek out and use knowledge from external sources, including analyses of reports submitted to the USP-ISMP Medication Errors Reporting Program, which are published in this newsletter. In 2008, take advantage of the ISMP Quarterly Action Agenda, a summary of actionable items that will be available in January, April, July, and October 2008. Challenge the status quo, and inspire and encourage all staff to track down bad news—both internally and externally—learn from it, and use it to improve patient safety. Help shatter assumptions that systems are safe until proven dangerous by a tragic event. And please, don’t let the heparin errors described above happen in your organization, or a needless death from mistakenly administering a neuromuscular blocking agent found among other vials of medication in the refrigerator, or accidentally administering vincristine by the intrathecal route, or… It has been said that those who do not learn from mistakes are destined to repeat them. Let’s join together and change the forecast for 2008.

Reference:

1. Reason J. Managing the Risks of Organizational Accidents. Hants, England: Ashgate Publishing Ltd;1997.