October 2011 Clinical Laboratory News: Two New National Quality Forum Serious Reportable Events Focus on Clinical Labs


Two New National Quality Forum Serious Reportable Events Focus on Clinical Labs
How Should Your Laboratory Prepare?

By Teresa Darcy MD, MMM

Earlier this year, a kidney transplant program at the University of Pittsburg Medical Center voluntarily shut down for failing to follow-up on a laboratory test result. A Centers for Medicare and Medicaid Services investigation into the case found that the results of a positive hepatitis C test were available in the living kidney donor's medical record for more than 2 months before her kidney was transplanted into a man who did not have the virus. Despite at least six chances to review the test result and possibly stop the potentially lethal transplant into the donor, none of the doctors or nurses involved in the case did so. While laboratory staff was not held responsible, for the first time a new update of the National Quality Forum’s (NQF) list of serious reportable events (SREs) focuses on the laboratory.

In June, the Board of the National Quality Forum, a voluntary organization that sets consensus standards for U.S. healthcare quality, endorsed an updated list of 29 SREs in healthcare. Defined as errors in medical care that are clearly identifiable, preventable, and serious in their consequences for patients, SREs include obvious unacceptable errors, such as wrong-site/wrong-side surgery and discharge of an infant to the wrong person. The new list, “Serious Reportable Events in Healthcare–2011 Update: A Consensus Report,” includes four new events, two of which are significant to clinical laboratories (See Box), along with 25 updated events from an earlier endorsement in 2006.

NQF Serious Reportable Events for Labs

The NQF initially defined 27 SREs in 2002 and revised and expanded the list in 2006 and again in 2011. For the first time, the latest list includes two new SREs related to the laboratory.

  • Patient death or serious injury resulting from the irretrievable loss of an irreplaceable biological specimen, and;
  • Patient death or serious injury resulting from failure to follow up or communicate laboratory, pathology, or radiology test results.

Source: Serious Reportable Events in Healthcare–2011 Update: A Consensus Report

The Origin of SREs

Kenneth Kizer, MD, MPH, former chief executive officer of NQF, first introduced the term “never event” in 2001 in reference to particularly shocking medical errors. Despite the widespread use and significant appeal of the phrase in the public arena, NQF does not use the term officially and in all its definitions and references calls such events SREs.

While NQF originally envisioned SREs as the basis for a nationwide state-based quality reporting system, only 24 states now require reporting of SREs. Many of the events, however, overlap with The Joint Commision list of sentinel events, which includes any unanticipated event in a healthcare setting resulting in death or serious physical or psychological injury to a patient that is not related to the natural course of the patient's illness. In addition, many of the NQF SREs are included on CMS’s 2008 list of hospital-acquired conditions that are nonreimbursable under the federal Deficit Reduction Act of 2005.

A new serious reportable event from the National Quality Forum 
includes misidentified specimens that cannot be replaced.

Why the Update?

For the 2011 update, NQF’s Board reviewed each SRE in terms of its applicability to four particular care settings—hospitals, outpatient or office-based surgery centers, skilled nursing facilities, and ambulatory practice settings, specifically office-based practices—and stipulated which events required public reporting for each care setting. Both of the two new laboratory-related SREs (See Box) are applicable to all four healthcare settings mentioned above. Currently, NQF has not provided much guidance for implementing these SREs; however, clinical laboratory professionals should be aware of them in case their organizations decide to adopt the new SREs.

Although the guidance is limited, NQF has given some hint of what labs should be concerned about. One issue is irretrievable loss of an irreplaceable biological specimen. This includes misidentified specimens and cases in which another procedure cannot be performed to produce a specimen. The serious injury to patients associated with this SRE is defined as progression of an undiagnosed disease or threat of disease that changes a patient’s life. For example, the patient requires monitoring that might not have been required if the specimen had not been lost. Guidance on failure to follow up or communicate test results also is limited, but events such as kernicterus in an infant that resulted from a failure to report an elevated neonatal bilirubin would fall into this category. A missed new diagnosis or an advancing stage of an existing diagnosis, such as cancer, would also be considered a serious injury resulting from a lack of communication.

Preparing Now

Given the high visibility of medical errors today, many healthcare organizations are likely to voluntarily mandate that labs track and report the new lab-related SREs, requiring labs to put new measures into place. At a minimum, labs may need to collect additional data, track specimens more closely, and implement new policies and procedures.

Some questions to think about before implementing a reporting system for irreplaceable samples are: 1) does your laboratory track loss of specimens, both those collected and never received and those received and not reported due to an error in the lab, such as a small tissue biopsy that is received but lost during facing of the paraffin block? 2) should the lab define what constitutes an irreplaceable specimen or should it evaluate the irreplaceability of each specimen loss? 3) how should irreplaceable specimens be reported to your institution’s quality organization? and 4) what is the appropriate patient follow-up when a specimen determined to be irreplaceable is irretrievably lost?

The SRE requiring follow-up and communication of laboratory results portends even more complex procedures. A patient might suffer an injury when there is a delay in the test result reaching the responsible clinician, or when the result was received but not communicated to the patient or acted upon by the provider. Clearly, laboratories should have procedures in place to minimize the former and could play a role in assisting the organization in meeting the latter. Some questions to consider are: 1) does your laboratory clearly understand the routing of results from all information systems? 2) if your institution has an electronic medical record, has your laboratory audited the record to ensure that results are routed to the appropriate caregiver and that they have been received? and 3) when a specimen is collected from an inpatient, but the results are available after the patient is discharged, who is responsible for follow-up with the patient and how can the laboratory ensure the patient has received the information?

Higher Visibility for the Lab

While there are many unanswered questions about how best to implement the two laboratory-related events added to the 2011 NQF SRE list, their addition is an acknowledgement of the importance of our work towards patient safety. Moving forward, laboratory professionals clearly need to become a powerful voice for patient safety in organizational discussions.


National Quality Forum releases updated Serious Reportable Events. June 13, 2011 
Website accessed August 18, 2011.

Serious Reportable Events in Healthcare–2011 Update: A Consensus Report 
Website accessed August 18, 2011.

Teresa Darcy, MD, MMM, is medical director for Clinical Laboratories at the University of Wisconsin Hospital and Clinics in Madison. 
Email: tdarcy@uwhealth.org.

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Patient Safety Focus Editorial Board

Michael Astion, MD, PhD
Seattle Children's Hospital
Seattle, Washington

Peggy A. Ahlin, BS, MT(ASCP)
Salt Lake City, Utah 

Corinne Fantz, PhD
Emory University
Atlanta, Georgia

James S. Hernandez, MD, MS
 Mayo Clinic Arizona
Scottsdale and Phoenix

Brian R. Jackson
ARUP Laboratories
Salt Lake City, Utah

Sponsored by ARUP Laboratories, Inc.