Q&A column

Dr. Kiechle is consultant, clinical pathology, Cooper City, Fla. Submit your inquiries to Sherrie Rice, srice@cap.org. Questions that are of general interest will be answered.

Q. My laboratory is struggling with the revised CAP checklist requirement COM.40850 “LDT and Class I ASR Reporting,” which says we need to describe the method and performance characteristics in our reports unless the information is available to the clinician in an equivalent format. Can you explain further?

A. The CAP has received several comments with concerns about the recent revision to the CAP’s all common checklist requirement COM.40850 on laboratory-developed tests and class I analyte-specific reagent reporting, including some comments on the American Association for Clinical Chemistry’s Artery discussion forum. The portion of the requirement under discussion is the statement that test reports include “a brief description of the method and performance characteristics needed for clinical use, unless the information is readily available to the clinician in an equivalent format (eg, test catalog).” The comments posted have included concerns that this information may clutter the patient report or not be of value to the clinician, and that there may be insufficient space in the test catalog to include this information.

The CAP Checklists Committee members would like to share insight on how to interpret this requirement. The information provided on the method and performance characteristics should be a brief summary. It is not intended to include detailed information as may be described in the laboratory’s procedures. The test catalog is listed as one example of an alternative location; however, laboratories may identify other formats for providing this information on demand as appropriate to their setting. It does not need to be provided routinely for each test every time it is reported.

This topic is also addressed in another checklist requirement, COM.40700 “Method Performance Specifications Availability.” There are also separate requirements in some of the checklists that already require a summary of the method to be included in the patient report, such as in the molecular pathology (MOL.49570) and histocompatibility (HSC.21275) checklists, where this information is essential to understanding the level of testing performed.