May 16, 2016

“Patient Safety Issues Spur NIH Shake-Up” was an above-the-fold headline in the Washington Post on May 11, 2016.  NIH Director Francis Collins, MD is replacing top leadership at the 200-bed Clinical Center with a new management team with experience in oversight, compliance and patient safety in the wake of an independent review that found that safety had become “subservient to research demands.”

Also in the news recently was a study published in The BMJ (BMJ 2016; 353 doi: http://dx.doi.org/10.1136/bmj.i2139 [Published 03 May 2016]) by researchers at Johns Hopkins urging the Centers for Disease Control (CDC) to list medical error, broadly defined, as the third most common cause of death in the U.S. after heart disease (611,105 deaths per year) and cancer (584,881 deaths per year).  According to the study, the annual number of U.S. deaths attributable to medical error is approximately 251,454—more than three times higher than the 98,000 preventable deaths cited by the Institute of Medicine in its famous 1999 study To Err is Human.

The number in The BMJ study may be much higher than the reality.  We should all be extremely concerned if indeed medical error is to blame for nearly ten percent of deaths.  The point here, though, is just that patient safety is a major health policy issue today and that anesthesiologists, who have a deservedly outstanding reputation in matters of safety, are well placed to lead the charge against preventable errors. 

Lack of transparency and of accountability may lead to an environment in which errors are overlooked, which seems to have been a big part of the problem at the NIH Clinical Center.  Both of those values can be transformed into a drive for improvement.  One familiar tool for improvement is the clinical checklist.  Although there are “mixed results regarding the clinical utility of checklists, the anesthesia community is increasingly interested in advancing research around this important topic,” noted Behrens et al. in their article The Ryder Cognitive Aid Checklist for Trauma Anesthesia appearing in the May 2016 issue of Anesthesia & Analgesia (doi: 10.1213/ANE.0000000000001186).

The Agency for Healthcare Research and Quality (AHRQ) defines a patient safety checklist as “an algorithmic listing of actions to be performed in a given clinical setting, the goal being to ensure that no step will be forgotten.  Although a seemingly simple intervention, checklists have a sound theoretical basis in principles of human factors engineering and have played a major role in some of the most significant successes achieved in the patient safety movement.”  AHRQ observes, further, that “[c]hecklists are a remarkably useful tool in improving safety, but they are not a panacea.  As checklists have been more widely implemented, it has become clear that their success depends on appropriately targeting the intervention and utilizing a careful implementation strategy.”

One of the most recent research reports to come out of an anesthesiology department was presented at the 2015 New York State Society of Anesthesiologists Postgraduate Assembly in Anesthesiology.  New PACU Handoff Checklist Improves Information Exchange (Anesthesiology News, March 29, 2016), an abstract presented by Christopher Potestio, MD, lead study author and CA-3 resident at Medstar Georgetown Hospital, showed that using a checklist for handoffs to post-anesthesia care unit (PACU) nurses took only 26 additional seconds to exchange 20 percent more information.  Communication errors between healthcare providers during PACU handoffs can easily occur in the “high-risk environment” of the PACU; an increase in the amount of key information is one way to mitigate the problem.

The Joint Commission (TJC) estimates that 80 percent of medical errors involve miscommunication during care transitions.  TJC currently requires hospitals to implement a standardized, interactive process to handover communications. 

The Physician Quality Reporting System (PQRS), too, reflects a consensus that has emerged regarding the benefits of using checklists in care transitions.  PQRS Measure #426 (Post-Anesthetic Transfer of Care Measure:  Procedure Room to a PAC) captures the “percentage of cases in which a post-anesthetic formal transfer of care protocol or checklist which includes the key transfer of care elements is utilized.”  Anesthesia departments looking for a sample checklist to follow or adapt might consider one published by Lin et al. in the May 2014 issue of the ASA Newsletter (Anesthesia Handovers:  Why Are They So Complicated?).  The mnemonic “PUTS PATIENT FIRST” makes this checklist very user-friendly:

Measure #427 (Post-Anesthetic Transfer of Care: Use of Checklist or Protocol for Direct Transfer of Care from Procedure Room to Intensive Care Unit) is analogous.  (Note:  these two measures can only be reported via a registry or a Qualified Clinical Data Registry [QCDR] such as the one offered by ABC.)

Another checklist measure is available to anesthesiologists who report their PQRS compliance through the Anesthesia Quality Institute’s QCDR:  ASA Measure #20 (Surgical Safety Checklist – Applicable Safety Checks Completed Before Induction of Anesthesia).  Noting that “In 2009, the World Health Organization (WHO) Safe Surgery Saves Lives Study Group published a study showing that utilization of a surgical safety checklist resulted in reduced perioperative mortality and complication rates.  Since then, surgical safety checklists have been widely implemented around the world.  Further studies confirm the WHO findings that implementation of the surgical safety checklist improves communication among members of the surgical team and reduces perioperative morbidity and mortality,” the AQI offers QCDR participants the opportunity to report on “patients, regardless of age, who undergo a surgical procedure under anesthesia who have documentation that all applicable safety checks from the World Health Organization (WHO) Surgical Safety Checklist (or other surgical checklist that includes the applicable safety checks for the specific procedure) were performed before induction of general anesthesia.”

The rationale for including ASA Measure #20 in the set of AQI-QCDR measures is, in part, that “compliance with surgical safety checklists and safety checklist protocols has been shown to vary widely.  The level of checklist compliance has been shown to vary depending on the implementation strategy.”  The potential penalties for PQRS under-reporting may not themselves be sufficient to motivate clinicians to spend the time to use checklists properly.  A successful strategy requires extensive preparatory work to maximize safety culture in the unit where checklists are to be used, engage leadership in rolling out and emphasizing the importance of the checklist, and rigorously analyze data to assess use of the checklist and associated clinical outcomes, according to AHRQ. 

Others have written of the critical role of culture and commitment for checklists to achieve their purposes.  Berry et al., in an editorial entitled “The Surgical Checklist:  It Cannot Work If You Do Not Use It” published in February 2016 in JAMA Surgery, observed that effective implementation poses ongoing challenges, such as requiring a 100 percent completion rate in order to improve significantly the effect of the checklist on patient safety, and that “A focus on the systems of care and promotion of a culture of safety at the institutional level is necessary to optimize checklist implementation.”

The province of Ontario required its hospitals to begin using surgical safety checklists by July 2010.  The effort failed to reduce the number of complications or deaths, as reported in the New England Journal of Medicine in March 2014.  Peter Pronovost, MD, who helped pioneer the use of clinical checklists, expressed concern that broad implementation without proper training and coordination of staff could interfere with rather than promote safety, according to an article published in Modern Healthcare on March 15, 2014 (Reality Check on Surgical Checklists), and also that government regulation of checklists was too slow to keep up with the changes in evidence-based practices.  In an editorial accompanying the NEJM study, Lucian Leape, MD, JD stressed the need to foster the hospital-specific customizations that would make checklists work in specific settings. 

Above all is the imperative of securing the commitment of the key players.  A structured initiative to get every hospital in the state to use a pre-surgical safety checklist process has been underway in South Carolina since 2013.  The South Carolina Hospital Association found that:

[A]cceptance of the checklist process varied from hospital to hospital, but those that had the most success had committed to following all of the steps needed to become high-reliability organizations—they offered leadership support, financial resources and cultivated staff members who were dedicated to the enterprise. They also allowed staff to customize the process.
…
To that end, the group brought in engineers with expertise in process improvement to visit every hospital, observe its procedures, and make recommendations to help each facility tailor the tool to meet its needs.

(Rice S. Making Checklists Work: South Carolina’s Statewide Experiment.  Modern Healthcare, January 23, 2016.)  One of the participating hospitals, Kershaw Health, succeeded with its own 25-item customized surgical safety checklist by taking the following steps:

• Surveyed all staff about what hindered checklist use
   
• Identified a physician champion to get surgeons on board
   
• Did monthly assessments to track how often the checklist process was skipped
   
• Used peer pressure because “no one wants to be seen as the outlier”
   
• Allowed staff to continually update and tweak the checklist
   
• Prominently posted reminders in the OR about timeouts and debriefs

In sum, implementing checklists is not a simple process, but it can be a rewarding one.  Some of the resources noted in this e-Alert may help readers get their own new or improved checklists off the ground.

With best wishes,

Tony Mira
President and CEO