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.
Bacteriology
- 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.
Mycobacteriology
- 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 checklistinput@cap.org.
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