College of American Pathologists
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Queries and comments

CLA probes problems, reacts to new rules and regs

October 2003
Stephen J. Sarewitz, MD

From the files of the CAP’s checklist-related questions. Answers by Stephen J. Sarewitz, MD, LAP checklist commissioner and staff pathologist, Valley Medical Center, Renton, Wash.

Q: Regulations indicate that mislabeled specimens should be rejected. Unfortunately, some of these specimens are of the type that cannot be recollected readily or appropriately—for example, cultures taken intraoperatively, cultures taken prior to antibiotic therapy, peak and trough levels, and tissue biopsies. Is there a legal way to report on these specimens, such as using a disclaimer or having the specimen collector accept responsibility for their authenticity?

A:The CAP’s laboratory general checklist (GEN. 40510) requires that specimens be identified uniquely to minimize sample mix-ups and mislabeling. Using a name-number system is ideal because it calls for two separate identifying items on each sample.

This requirement is echoed in the discipline-specific checklists, including the chemistry and toxicology checklist (CHM. 11800), and necessitates that procedures be able to verify the identity and integrity of samples, including capillary specimens, aliquots, and dilutions.

This requirement does not, however, preclude the laboratory from exercising judgment regarding the disposition of suboptimal specimens, such as mislabeled containers. For example, checklist question CHM.11900 (from the chemistry and toxicology checklist) asks, “Are there documented criteria for the rejection of unacceptable specimens and instructions for the special handling of suboptimal specimens?” The note to
CHM. 11900 states, “This question does not imply that all ‘unsuitable’ specimens are discarded or not analyzed.”

It is reasonable for the laboratory to allow mislabeled specimens to be analyzed under special circumstances, such as when obtaining a repeat specimen is difficult or impossible—for example, with timed blood draws, biopsies, or cerebrospinal fluid. In such cases, it is appropriate for the laboratory to require clinical personnel to relabel the specimen container correctly or to obtain a written statement from clinical personnel attesting to the identity of the patient from whom the specimen was taken. A disclaimer should also be included in the written report.

Any policy that would allow the reporting of results from an improperly labeled specimen should be developed with the approval of the institution’s risk manager, legal counsel, or liability insurer, or all of the above. And the laboratory should consider monitoring mislabeled specimens as part of its quality improvement program.

Q: How will the CLIA ’88 regulations issued Jan. 24, 2003 affect quality control requirements in the microbiology checklist?

A:The Jan. 24 CLIA ’88 regulations relaxed certain quality control requirements in microbiology but tightened others. These QC changes will be reflected in the next edition of the microbiology checklist, to be released later this year. The changes are summarized below.


  • For common biochemical tests, the checklist currently requires that positive and negative controls be run each day of use. The updated regulations require that controls be tested only for each new batch, lot number, and shipment of reagent.
    The new checklist question will read, “Are positive and negative controls tested and results recorded for each new batch, lot number, and shipment of the following: reagents—catalase, coagulase, oxidase; disks—bacitracin, optochin, ONPG, X, V, XV; and identification systems?”
  • For diagnostic antisera, the checklist currently requires that controls be run monthly. This requirement will be changed to every six months.
    The new checklist question will read, “Are positive and negative controls tested and results recorded for each new batch, lot number, and shipment of antisera when prepared or opened and once every six months thereafter?”
  • The requirement for performing quality control on Gram stains weekly has not changed.

  • Currently, non-immunofluorescent acid-fast stains must be checked each week of use. The new checklist edition will require that results be checked with positive controls each day of use.
  • The checklist currently requires fluorescent acid-fast stains to be controlled weekly or each day of use, whichever is less frequent. The new checklist will require that fluorescent stains be checked with positive and negative controls each time they are used.
  • In the current checklist, biochemical tests for mycobacterial identification must have positive controls run each day of use. The only mycobacterial biochemical test requiring a negative control is the iron uptake test. In the new checklist, the requirement for a negative control will be extended to all biochemical tests.

The Commission on Laboratory Accreditation continually revises the CAPchecklists to keep checklist content state-of-the-art in laboratory medicine and make the checklists as user-friendly and easy to interpret as possible. The commission welcomes input from laboratories and inspectors regarding potential improvements to the checklists. E-mail suggested checklist changes to