Hundreds of questions roll in each year about Laboratory Accreditation Program requirements. CAPTODAY continues to publish a sampling of those questions and their answers, written by LAP checklist commissioner Albert Rabinovitch, MD, PhD, chief medical officer-vice president of Specialty Laboratories, Santa Monica, Calif. As head of all LAP checklist activity since 1993, Dr. Rabinovitch has years of experience and insight we're pleased to share.
Q: I am doing an internal QI probe to measure turnaround times for nongynecologic cytology cases. How should I determine the beginning and end points for the study? Should the time be measured from when the specimen is collected, received in the lab, or processing is begun? And conversely, is the case considered complete when the case is verified, the report printed, or the report distributed? I know there is a proposed addition to the cytopathology checklist concerning nongynecologic TAT, so I want to be sure we are compliant.
A: The current version of the cytopathology checklist states, "Are 90% of reports on routine nongynecologic cytology cases completed within two working days of receipt by the laboratory performing the evaluation? (Cyp.06532)" That sets the start of the clock. There is no further specificity of "completed." In any event, the goal of QI is to improve laboratory performance. You are free to define your own start and end times, then see what system changes will improve the TAT. Ultimately, the clinical TAT begins when the physician thinks to submit a specimen and ends when the result reaches his/her brain. A very short within-laboratory TAT (specimen arrival to report leaving the lab) may be useless if there is a delay in specimen collection, the specimen languishes for some time before reaching the laboratory, and the laboratory report takes days to actually reach the physician's eyes. The bottom line is you must tailor such TAT studies to your own setting, remembering the clinically relevant clock function. Also, you should probably begin by defining clinicians' expectations: If they want four days and you are already achieving three days, there is little purpose in shortening TAT to two days.
Q: Question Gen.30050 reads, "For those tests performed using different methodologies or instruments or at different testing sites, is there a defined mechanism to verify the comparability of results throughout the clinically appropriate range?"
We have an off-site POL performing moderate complexity testing on several clinical analyzers. We are also performing these tests within our hospital laboratory, on different instruments. Each facility has its own CLIA number and its own CAP number. We are approximately 1.5 blocks away from each other, but the office is owned by the hospital. Do we need to do comparability testing between these two different sites?
A: Patient-based comparisons must be conducted within a given CAP/CLIA number. The intent of this item is to minimize or eliminate variations in patient test results caused by different method systems. One would not expect physicians to differentiate between true changes in patient results versus variations caused when tests are performed on different instruments or in different patient care settings (e.g. a blood gas performed in the surgery unit versus an inpatient unit). If the different testing sites are located in different physical locations and are under separate CAP numbers, the CAP does not require that these results be correlated, inasmuch as accreditation is by individual CAP number. From a clinical perspective, however, it is important that results match if the patients have the same tests performed at different testing sites under the same parent organization with multiple CAP/ CLIA numbers.