college-age acquaintance recently confided to me that an employee who works with her at a physician's office lab as part of her medical-office internship “keeps using the wrong chemical on the test smear.” I asked if she had corrected her colleague. “Yes, but she said she knows what she is doing. Besides, the doctor will find out soon enough.” Right, I wondered, but at what cost? Will the unsuspecting doctor see his equally unsuspecting patient return for her next visit with full-blown cervical cancer?
My mother lamented 20 years ago over her granddaughter's poorly sewn bathing suit: “She will grow up never knowing what real quality is.” In those long-ago days, I doubt mama's opinion would have included healthcare.
Recently, however, news outlets have covered multiple examples of poor quality patient healthcare — not necessarily in the lab — and when these occur in the U.S., a hue-and-cry goes out for a solution, a remedy is found, and the fix is implemented.
A recent example is that of a 2D-barcode solution to avoiding errors in standard Code 128 barcode technology for patient identification (see http://tiny.cc/gnwus).This 2D technology has “sophisticated algorithms for error correction and redundant data embedded within the barcode … in some cases, up to 30% of the barcode can be destroyed and an accurate scan can still be obtained,” says Corinne Fantz, PhD, of the Patient Safety Focus editorial board.
Recently, the accrediting body COLA issued its white paper entitled “Federal government questions quality in waived testing: the hard facts and what can laboratories do now?” (http://www.cola.org/waived.html) explaining the growing role of waived lab tests — exempt from most federal oversight.
This paper documents mounting evidence that “significant quality problems exist in the largely unregulated labs relying on these tests, with the potential to contribute to errors and even patient harm.”
COLA notes research since 1992 shows the number of CLIA-waived tests increased from eight to 100+, representing some 1,600 test systems. At the same time, the number of labs with a certificate of waiver grew from 20% to 60% of the more than 209,000 U.S. lab-testing sites.
Among the problems cited at more than half of these waived-testing sites are that:
- more than 20% do not routinely check product inserts for instructions or changes to those instructions;
- more than 20% do not perform QC testing specified by manufacturers' instructions; and
- almost half do not document the name, lot number, and expiration dates for tests performed.
The COLA paper points out that despite “the law and the FDA's assertion that risk of patient harm is insignificant from incorrect performance of tests, waived tests are not error-proof and are not always performed in settings that use a systems approach to quality and patient safety.”
As a heart patient on blood-thinning meds, my personal eye-opener was the paper's example of “prothrombin-time testing in patients undergoing anticoagulant therapy and glucose monitoring in diabetics.” Another example of where erroneous results from diagnostic tests can have “innumerable unintended consequences are those for HIV antibody.”
If even the simplest lab test is performed poorly by an employee in an environment where ongoing education and appropriate training are not encouraged … if she works where high personnel turnover impacts the lab … or if she performs non-waived tests absent the CLIA-required quality measures, we all pay the price — and, I have learned, some of us will pay a higher price than others.