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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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