College of American Pathologists
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  Queries and Comments


April 2006
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: The term “commentary” in CAP checklist questions has been replaced with the word “note.” Can you explain why?

A: A note within a checklist question can serve multiple purposes. Sometimes it elaborates on the intent of the checklist requirement. Other times it provides examples of how the laboratory can meet the intent of the requirement. The note may also state the components of the requirement. Notes are integral to checklist questions, and laboratories must comply with the requirements in a note just as they comply with the requirements in the text of the checklist question.

The commentary was designed to communicate checklist deficiencies to laboratories, and as such, is obsolete since the pink deficiency forms filled out by the inspection team now serve this purpose. The commentary is gradually being phased out, and useful information from the commentary is being integrated into the notes.

Notes may include the words “must” or “should.” The word must is associated with phase II checklist questions and indicates a requirement. The laboratory will be cited as deficient if it is not in compliance. The word should is associated with a phase I question or may indicate a recommendation for good laboratory practice.

Q: Is there a documented program to ensure that each person performing point-of-care testing maintains satisfactory levels of competence? The note in this CAP point-of-care testing checklist question (POC.06900) lists six elements for evaluation. Do personnel need to be evaluated for all six elements for each test they perform?

A: It is not necessary to evaluate competency for each test a person performs. The six elements listed in the note for this question are common practices that apply to many testing procedures. It is important that the person demonstrate competency for these common elements.

For example, documentation of the first element on one of the POC testing procedures would suffice, while documentation of the second element on another POC procedure would suffice, and so on.

The note reads:

The records must make it possible for the inspector to determine what skills were assessed and how those skills were measured. Some elements of competency assessment include, but are not limited to:

  1. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing, and testing
  2. Monitoring the recording and reporting of test results
  3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records
  4. Direct observation of performance of instrument maintenance and function checks
  5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples
  6. Evaluation of problem-solving skills.

Q: How often must I verify the accuracy of my automatic pipettes?

A: The answer to your question can be found in the chemistry/toxicology checklist. Checklist question CHM.24200 reads:

Is there a documented procedure defining how pipettes are checked for accuracy of calibration (gravimetric, colorimetric, volumetric, or other verification procedure) before being placed in service initially and results documented?

Note: Automatic pipettes (fixed volume adjustable and/or micropipettes) must be checked for calibration accuracy either by volumetric, colorimetric, gravimetric, or other means before being placed in service initially and results documented.

Checklist question CHM.24300 also addresses this question. It reads:

Are automatic pipettes used for quantitative dispensing checked for accuracy and reproducibility (gravimetric, colorimetric, or other verification procedure) at specified, periodic intervals, and are the results recorded?

Note: For analytic instruments with integral automatic pipettors, the accuracy and precision of the pipetting system should be checked periodically, unless that is not practical for the end-user laboratory. Manufacturers’ recommendations should be followed.

Laboratories must check pipettes for accuracy of calibration and reproducibility before placing them in service. These checks must occur periodically thereafter. Periodically is defined by the laboratory and depends on frequency of use, reliability, and manufacturers’ recommendations. The laboratory should consider recalibrating the pipettes if problems are suspected.

Q: Can we use bar-coded labels on the glass slides in our anatomic pathology department?

A: It is acceptable to use bar-coded labels on such slides. The labels are useful for tracking specimens and reducing errors.

Bar coding is considered an automated prelabeling system and is mentioned in the note to anatomic pathology checklist question ANP.21150, which reads, “Are slides identified adequately?”

In the next edition of the anatomic pathology checklist, which will be released this fall, the note to this phase II question will be revised to more clearly indicate that bar-coded labels are acceptable.