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 would appreciate some clarification regarding checklist question IMM.35050 (temperature checks). My laboratory was given a Phase II deficiency for not recording temperatures on refrigerators and freezers on Sundays. Our laboratories are closed on Sundays, and temperatures are checked on Monday morning. We have a comment that the laboratory is closed on Sundays and a "/" is written on the charts for those days to indicate that temperatures are not recorded. Please comment on this deficiency and provide some suggestions on how to address it.
A: The point of the checklist question is to ensure the temperatures of such devices containing labile materials do not change to the point of affecting the contained reagents, controls, patient samples, etc. It is not about ritualistic recordings to satisfy an external inspector, but rather the ability to document that temperatures were monitored. Were a power failure to occur early Sunday, with recovery before the next day, thermal damage to contents would not be detected by your six days of temperature recording.
A simple solution is to obtain some minimum/maximum thermometers so that staff need only check the thermometers on Monday to ensure ranges were not exceeded during the preceding day. Your protocols must so specify, including an explanation of your "/" symbol on the records.
On a related note, laboratories must be very cautious about long-term storage in self-defrosting devices, as these have warming cycles that are not captured by discontinuous temperature records. In contrast, a heat block or similar device that is used only on days of patient testing but otherwise does not contain any materials need only be checked on patient-testing days.
Q: In light of the huge improvements in hematology instrumentation, I wonder why we must continue to run two levels of controls each eight hours? Most chemistry systems only are required to run two levels each 24 hours. When I ask the manufacturers of hematology equipment why their recommendations are for QC each eight hours, they say it is a regulatory requirement. A CLIA '88 inspector I talked to said the hematology community wanted to keep it this way. So this seems like a circular argument and not a requirement that is based on good practice. It seems unreasonable to me that today's stable instruments would require six controls a day (plus moving averages, etc.). An instrument that drifted would require more frequent calibration, wouldn't it? I realize things take time, but hematology needs to step up to the plate and ask for a reasonable requirement and not one based on the past. What can I do to help this along? It seems as though we would have all the data we needed with the QC and calibrations we have been running over the years.
A: Your point is well taken. The only reason the hematology and coagulation checklist specifies two levels every eight hours is because of the CLIA '88 regulation at 42CFR493.1253(b), which reads, "For non-manual hematology testing systems, excluding coagulation, the laboratory must include two levels of controls each eight hours of operation." You should communicate your concerns to the Health Care Financing Administration. As former chair of the CAP Hematology and Clinical Microscopy Resource Committee, I can comfortably state that this is not a CAP position. Indeed, the checklists make it clear that only two control levels are required, even though manufacturers continue to market three-level controls, including the essentially useless low-level control.
I agree that this makes no scientific sense in light of today's instrumentation, and the thinking behind the regulation is obsolete by well over a decade. Of course, such a regulation favors the commercial vendors of hematology QC material by virtue of increased product sales. That is the only part of the hematology community that I can imagine supports the CLIA '88 language. Thus, they might be unlikely to want the regulations changed, although, from an ethical viewpoint, they might feel otherwise and be willing to make a point with HCFA.
You may wish to initiate a dialogue with hematology instrument-reagent manufacturers.