The Milwaukee Journal Sentinel has done an excellent series on patient safety issues related to laboratories (Gabler 2015). Gabler does a great job using real people stories to illustrate the devastating impact a lab error can have on the lives of patients and their families. But she goes much further and delves into the lack of transparency about laboratory errors and the inability of the general public or even you, the healthcare professional, to know how well the laboratory to which you refer patients is actually performing.
Our regular readers know we are fond of “stories, not statistics” to foster patient safety. Gabler shows how inaccurate HIV diagnoses and false paternity tests destroyed families and incorrect pregnancy testing and blood compatibility testing put neonates in jeopardy. And how failure to heed a lab technician’s warnings about a faulty analyzer resulted in that lab tech being exposed to HIV and HCV and more than 400 patients possibly receiving inaccurate HIV and HCV results.
But, while the stories in this series are indeed compelling, the statistics are even more bothersome. Gabler uncovered not only numerous specific errors and deviations occurring in various labs but also found significant flaws in the regulatory oversight of the labs. Labs appear to have the ability to choose some quality parameters as they see fit and they can choose their oversight organization in some cases. One example given was a lab in which staff failed proficiency testing in pregnancy testing one quarter. Yet rather than do repeat proficiency testing for pregnancy testing that lab “simply didn’t participate in an outside check of its pregnancy testing the following quarter”. Gabler also discusses labs cutting corners to save money (eg. using expired reagents, putting off fixing faulty equipment, etc.).
There are 35,000+ labs in the US. While they must meet the federal standards of the Centers for Medicare and Medicaid Services (CMS), the surveys are usually outsourced to other organizations. State inspectors handle about 50% of labs, with accrediting organizations like The Joint Commission (TJC) or the College of American Pathologists (CAP) reviewing 46%, including most hospitals and large clinics. New York and Washington run their own programs, accounting for the remaining 4%. CMS sends teams to survey a small percentage of labs (about 2%) and to audit the surveys being done by those other organizations.
When CMS does those audits they allow up to a very generous 20% disparity rate (between the CMS findings and the other organization’s findings) before CMS reviews the work being done by those organizations. In 2013 The Joint Commission exceeded that 20% threshold, with 9 of 43 audited inspections not meeting the CMS expectations.
But the public might become aware of faulty laboratory practices only if a regulatory body sanctions that lab. And such sanctions are relatively rare. Findings of surveys are not made public if the lab submits a plan of corrective action that is accepted by the oversight agency.
We all appreciate it when organizations like The Joint Commission take on an “educational” role and an approach to facilitate improvement. But at the same time we don’t want to be sending our patients to a lab that has substandard processes.
So how do you know if your favorite lab is safe or not? You won’t find the answer on any website. Your best bet is to be tied into your hospital’s quality improvement system and make sure that your medical staff representation on all the quality committees is actively participating. But that will only help you get a feel for how safe the hospital lab is. For those using proprietary and/or commercial labs, good luck!
So why aren’t there publicly available measures of lab quality and safety? There is certainly considerable public reporting of hospital quality and safety measures (albeit some good and some bad measures). But a patient is actually much more likely to use a lab than a hospital. The vast majority of quality indicators monitored in laboratories are either too technical or of little interest to the general public. But some potential candidates for publicly reported measures might be:
Of course, you’d have to have standardized ways of determining these measures so the system cannot be “gamed”.
We’ve done multiple columns on errors related to laboratory studies (see list below), many or most of which actually occur before the specimen arrives at the lab (as in our Patient Safety Tips of the Week for October 9, 2007 ““ and March 6, 2012 ““Lab” Error”). Lost lab specimens can leave patients without a diagnosis (see our November 16, 2010 Patient Safety Tip of the Week “ ”). One particularly serious error highlighted in several of our columns is mislabeling of specimens. A CAP study in 2011 had shown a specimen labeling error rate of 1.1 per 1000 cases (Nakhleh 2011). Because that has such potentially devastating consequences for patients, the College of American Pathologists (CAP) has just issued guidelines for uniform labeling of blocks and slides in surgical pathology (Brown 2015). CAP put together a panel of experts to develop that guideline. A systematic literature review found the overall evidence inadequate to inform the guideline so the panel had to rely on expert consensus opinion for 10 of their 12 recommendations.
In several of our columns on specimen mislabeling errors we’ve mentioned that you, as a clinician, should be suspicious when a “surprise” diagnosis (or lack of an expected diagnosis) comes back from the lab. There are DNA-based tools that labs can use to look for switched or cross-contaminated lab specimens.
There are other checks that can be done for some highly sensitive tests. For example, in the Gabler article one lab has two samples of each person's DNA tested by two different lab technicians. Another safeguard requires that whenever a man is excluded as father of a child, the company double-checks to make sure the child's swab wasn't accidentally switched with the mother's swab, since the two often have their cheeks swabbed at the same time.
So, how safe is the lab you use? What quality indicators would you like to see for those labs?
Some of our other columns on errors related to laboratory studies:
Gabler E. Hidden Errors. A Watchdog Report. Weak oversight allows lab failures to put patients at risk. Milwaukee Journal Sentinel 2015; May 16, 2015
Nakhleh RE, Idowu MO, Souers RJ, et al. Mislabeling of cases, specimens, blocks, and slides: a College of American Pathologists study of 136 institutions. Arch Pathol Lab Med 2011; 135(8): 969-974
Brown RW, Speranza VD, Alvarez JO, et al. Uniform Labeling of Blocks and Slides in Surgical Pathology. Guideline From the College of American Pathologists Pathology and Laboratory Quality Center and the National Society for Histotechnology. Arch Pathol Lab Med 2015; Early Online Release April 21, 2015
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