College of American Pathologists
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  Queries and Comments


December 2005
Originally published in CAP TODAY

Stephen J. Sarewitz, MD

Q: Does the physician performed section of the CAP point-of-care checklist apply to hospital physicians who perform testing on their patients?

A: Even though physician-performed testing may be conducted in an institution, you do not necessarily need to complete that section on the checklist. The section on physician-performed testing must be completed only if such testing is performed under the same CLIA number as the laboratory testing and the laboratory director is responsible for conducting competency assessment of physicians.

The requirements of the remainder of the POC checklist and laboratory general checklist do not apply to the section on physician-performed testing.

Q: How do the questions in the transfusion medicine checklist about tracking critical materials apply to materials used for transfusion? My institution's central supply area sends infusion sets and filters directly to the nursing units. Is the laboratory responsible for tracking these materials?

A: The definition of critical materials was changed in the Oct. 31, 2005 edition of the transfusion medicine checklist to "a good or supply used in the collection, preservation, storage, preparation, or testing of blood components that directly affects quality or patient safety (for example, blood collection sets)." The new definition omits the word "transfusion" and adds the word "preparation."

The intention is for the transfusion service to be responsible for monitoring and tracking materials the laboratory defines as critical to its service and that are used in the laboratory. Because materials used for transfusion of blood components bypass the laboratory in most institutions, the CAP lets each institution decide whether to monitor and track these materials.

Q: What are the CAP patient safety goals, and how are labs supposed to address them?

A: The College has developed a core set of laboratory patient safety goals for pre- and post-analytic laboratory processes. The goals are to:

  • improve patient and sample identification at the time of specimen collection, analysis, and results delivery.
  • improve the verification and communication of life-threatening or life-altering information regarding malignancies, HIV and other infections, cytogenetic abnormalities, and critical values.
  • improve the identification, communication, and correction of errors.
  • improve coordination of the laboratory patient safety role within health care organizations—that is, with nursing, administration, point-of-care testing personnel, and providers.

The CAP checklists contain multiple questions pertaining to patient safety goals. Laboratories should review their processes related to these goals to determine if improvements are needed and what actions are necessary. For example, it may be appropriate to monitor key indicators related to one or more goals, such as number of mislabeled specimen containers, or to change certain procedures to improve performance, or to define sentinel events related to the goals.

CAP inspectors will, during the course of an inspection, ask for documentation that laboratories have evaluated their processes related to patient safety goals and have taken appropriate action.

Q: A prior immunology checklist said that if there was a test that an institution did dilutions for, such as antinuclear antibody and rheumatoid antibody, the institution needed to have a titered control on each day of testing of dilutions. I see no reference to this in the latest edition of the checklist. What does the College want us to do? I have found titered controls for each. Do we need to run the titers if we have no positive patients just to show that we can identify the cutoffs? Most positive controls with the kits are higher than the cutoff.

A: The ANA method provides a simple and sensitive technique for detecting and measuring these antibodies. If the initial screening method is positive, additional immunologic evaluation is necessary to determine the specificity of the reaction. Various test methods and techniques can be used to perform this evaluation. You do not indicate which testing method or instrumentation your laboratory uses. Each manufacturer may have specific requirements for the test method or instrumentation, or both, and these requirements should always be followed.

For quantitative testing, the College requires the testing of control materials at more than one concentration each day of analysis for all tests performed (checklist question IMM.34120). Controls should verify assay performance at relevant decision points. This may be determined based on clinical or administrative criteria.

Positive and negative controls must be included with each patient run for all fluorescent antibody stains (IMM.34450). The lab should check stains each day of use for intended reactivity to ensure predictable staining characteristics (IMM.34400).

For qualitative and semi-quantitative antigen-antibody tests that do not include built-in positive and negative controls, laboratories must test known positive and negative controls on each day of analysis (IMM. 34300). For qualitative and semi-quantitative antigen-antibody tests that include positive and negative internal controls, laboratories must test a positive and negative external control with each new kit lot number or different shipment of a given lot number. Users must follow the manufacturer's instructions.

For panels or batteries, they must employ controls for each antigen or antibody sought in patient specimens (IMM.34325). They must use reactive, weakly reactive, and nonreactive controls in test systems where results are reported in that manner (IMM.34170).

For syphilis serology, laboratories must run a negative control and positive serum controls of known titer or controls of graded reactivity each day of patient testing (IMM.41300). If the laboratory reports graded patient results, then it must run graded controls.

Laboratories need to examine control serums before examining patient specimens. The control results must provide the correct positive and negative reactions to validate procedural results. For positive ANA results, a grading scale may be helpful in establishing the criteria for each laboratory. All positive ANA patterns should be titered to endpoint dilution to detect possible mixed antinuclear reactions that may not be apparent when interpreting a single screening dilution.

It is up to the laboratory director to determine if titered controls are required for his or her laboratory based on the testing methodology used.

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

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