College of American Pathologists
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  Queries and Comments


April 2007
Originally published in CAP TODAY

Stephen J. Sarewitz, MD

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

Q: I noticed that waived testing is included in the latest edition of the checklists. Can you provide a summary of these requirements?

A: Certain requirements for waived testing were changed in the most recent checklist edition, released Oct. 31, 2006. Waived testing is covered in the checklists for point of care, chemistry, hematology, immunology, microbiology, urinalysis, and limited service.

Following is a summary of the waived testing requirements. (Please refer to the checklists for further information regarding waived versus non-waived testing.)

Summary of waived testing requirements


  1. Lot-to-lot reagent validation not required
  2. Follow manufacturer instructions for handling and validating

Competency (same as for non-waived testing)

  1. Assess competency every six months during the first year that a person performs patient testing
  2. Reassess competency at least annually


  1. Initial correlation between waived instruments—for example, glucose meters—not required
  2. Correlation between waived instruments and main lab instrument not required
  3. Multi-instrument comparison not required

Quality control

  1. Follow manufacturer instructions
  2. Be sure QC results are judged acceptable and recorded before releasing patient results. Document corrective action if control results exceed tolerance limits. Internal control results need not be documented for instruments using such controls if, and only if, an unacceptable instrument control automatically locks the instrument and prevents the release of patient results
  3. Frequency of QC is defined by the manufacturer 4. External controls run as required by the manufacturer

Calibration and calibration verification

  1. Follow manufacturer instructions. Calibration verification every six months is not necessary unless required by the manufacturer

Analytical measurement range

  1. Follow manufacturer instructions. Initial analytical measurement range validation and six-month interval validation are not necessary unless required by the manufacturer

Method performance specifications

  1. Verification not required, except for reference range Other checklist requirements—in proficiency testing, instrument maintenance, procedure manuals, personnel, specimen handling, results reporting, and safety—remain the same for waived and non-waived testing.

Q: What should an inspector look for with regard to team leader checklist item TLC.10800, phase II, which asks, “Does the director interact with government and other agencies as appropriate?”

A: The intent of this question is to ensure that the medical director is available or reachable for inspections conducted by the state, CAP, Centers for Medicare and Medicaid Services, or other entities. If the director is rarely available to the laboratory, this may be a red flag and could possibly be cited as a deficiency. The medical director must also be aware of whom to contact should questions or problems arise and be directly involved with patient or personnel complaints within the laboratory or that were submitted to the state.

The inspector may ask the medical director to give an example of a specific state or local requirement and what the laboratory does to comply with that requirement. Applicable state and local requirements may include but are not limited to handling radioactive materials, shipping infectious or diagnostic materials, personnel qualifications, retention of specimens and records, hazardous waste disposal, fire codes, medical examiner or coroner jurisdiction, legal testing, acceptance of specimens only from authorized personnel, handling controlled substances, patient consent for testing, confidentiality of test results, and donation of blood. The checklists contain specific questions about these areas.

The medical director and laboratory may obtain information on applicable state and local laws and regulations from multiple sources, including hospital management, state medical societies, and state departments of health.

Q: Does the note on microbiology checklist question MIC.21040 mean that if we are performing weekly quality control on susceptibilities and our weekly QC is unacceptable, we must repeat all of our results since the last week’s results?

A: Not necessarily, but good laboratory practice means you should evaluate what is out of control, look for the root cause, and ascertain if there are issues with a particular drug/bug combination or instrument issues that could have affected your results from the previous week. If the problem could have affected patient results, then you should repeat all of those patient isolates. The cause often will be an isolated occurrence and you need not do more than document the corrective action taken and that you performed a look-back and detected no trend or issue.

The new microbiology checklist question MIC.21040, phase II, reads:

Is there documentation of corrective action when control results exceed defined tolerance limits?

Note: Patient test results obtained in an analytically unacceptable test run or since the last acceptable test run must be re-evaluated to determine if there is a significant clinical difference in patient/client results.