Originally published in CAP TODAY
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: What are the CAP's quality control requirements
for the new molecular systems to detect methicillin-resistant Staphylococcus
aureus, or MRSA?
A: The most recent revision to microbiology
checklist question MIC.63262, phase II, addresses quality control. The
checklist item reads:
Are controls run daily for quantitative and qualitative
Controls should verify assay performance at relevant
clinical decision points. Controls must be run at least as frequently
as recommended by the manufacturer.
Note 1: Except for tests meeting the criteria in
Note 2, below, external surrogate sample* controls must be run as follows:
a. For quantitative tests, 2 controls at 2 different
concentrations must be run daily.
b. For qualitative tests, a positive and negative
control must be run daily.
Control testing is not necessary on days when patient
testing is not performed.
Note 2: Daily controls may be limited to built-in/electronic/procedural
(e.g., internal) controls for tests meeting all the following criteria:
1. For quantitative tests, the test system includes
2 levels of electronic/procedural/built-in internal controls that are
2. For qualitative tests, the test system includes
a built-in/electronic/procedural control run daily.
3. The laboratory has performed and documented studies
to validate the adequacy of limiting daily QC to the built-in/electronic/procedural
controls. The validation protocol should be defined by the laboratory
4. External surrogate sample controls (as indicated
in Note 1a and 1b, above) are run for each new lot number or shipment
of test materials.** For qualitative tests, best practice is to also
run a sensitivity control on new lots of reagents/test materials using
a previously tested patient specimen or other external material. The
sensitivity control is used to verify detection of low-level target
sequences, e.g., pathogens or tumor markers.
*A "surrogate sample" is a specimen designed to simulate
a patient sample for quality control purposes. For example, traditional
external liquid control materials are considered surrogate external
surrogate sample controls.
**Repetition of the initial validation study is not
required when running external surrogate sample controls with new lots/shipments
of test materials.
Q: Are references available about notifying
doctors' offices about high-grade malignancy cases? We cannot find a requirement
for this practice in the CAP checklists. I know CLIA requires laboratories
to report malignancies and critical values, and we consider high grade
to be similar to a critical value, so we contact the physician.
A: CLIA has no specific requirements
about reporting malignant or premalignant diagnoses. There is a common
misunderstanding about CLIA and CAP checklist requirements for communicating
critical results. A critical result denotes that a condition is imminently
life threatening. Most diagnoses of malignancy and premalignancy do not
indicate that the conditions are imminently life threatening, so the conditions
would not be considered critical values. However, reporting a malignancy
appropriately is a CAP safety goal, as noted in laboratory general checklist
item GEN.20365, phase II:
Does the laboratory address the current CAP Laboratory
Patient Safety Goals?
Note: The current CAP Laboratory Patient Safety Goals
are: 1) Improve patient and sample identification at specimen collection,
analysis and resulting; 2) Improve verification and communication of
life-threatening or life-altering information regarding malignancies,
HIV (and other serious infectious diseases), cytogenetic abnormalities,
and critical results; 3) Improve identification, communication, and
correction of errors in a timely manner; 4) Improve the coordination
of the laboratory's patient safety role within healthcare organizations.
The laboratory must document that these goals have been addressed by
evaluation and/or monitoring of the processes involved. Laboratory processes
related to the Patient Safety Goals must be evaluated on an annual basis.
The reporting of a malignancy is also subject to anatomic
pathology checklist question ANP.12175, phase I, on the reporting of unexpected
or significant surgical pathology findings. The question reads:
Is there a policy regarding the timely communication,
and documentation thereof, of significant or unexpected surgical pathology
Note: Certain surgical pathology diagnoses may be
considered particularly significant or unexpected. Such diagnoses may
include: malignancy in an uncommon location or specimen type (e.g.,
hernia sac, intervertebral disk material, tonsil, etc.), absence of
chorionic villi when clinically expected (potential ectopic pregnancy),
change of a frozen section diagnosis after review of permanent sections,
and/or mycobacterial, fungal, or other significant infectious organisms
identified on special stains. Diagnoses to be defined as "significant"
or "unexpected," if any, should be determined by the pathology department
in cooperation with local clinical medical staff. Consideration should
be given to assuring, with reasonable effort, prompt communication of
such results by telephone, pager, or other system. There should be documentation
of date and time of such special notification (which may be included
in the pathology report or in laboratory files).
As you noted, the cytology checklist does not require
the laboratory to notify submitting physicians about new diagnoses of
high-grade squamous intraepithelial lesion, or HSIL, gynecologic cytology
cases. A diagnosis of HSIL is not considered to be unexpected in most
laboratories. It is up to the laboratory director to determine if such
a diagnosis should be reported in a special manner.
Q: Do I have to vent the microwave oven
if it is being used to warm slides or heat simple solutions and is being
used in a negative pressure room?
A: Venting is only required for microwave
devices being used for fixation, processing, or decalcification, in which
volatile, potentially toxic solutions are being used. Venting is not required
for staining procedures using nonvolatile, nontoxic reagents, such as
iron staining. If volatile solvents are being processed in the microwave
and you can smell the vapors in the room, the microwave device is not
In general, simply placing the microwave in a negative
pressure room is not adequate-unless the unit were placed next to an exhaust
vent and the solvents could not be detected by smell. Free-standing hoods,
which are often used for small linear stainers, may eliminate the need
for venting to the outside.
Anatomic pathology checklist question ANP.29430, phase
I, addresses this question. It reads:
Are microwave devices properly vented?
Note: Microwave devices should be placed in an appropriate
ventilation hood to contain airborne chemical contaminants and potentially
infectious agents. Before operation of the microwave device, flammable
and corrosive reagents should be removed from the hood to prevent fire
or chemical damage to the electronic components of the device. Microwave
devices used outside a fume hood should have an integral fume extractor
that is certified by the manufacturer for use in a clinical laboratory.
The effectiveness of ventilation should be monitored
at least annually.
This checklist question does not apply if only non-hazardous
reagents (and non-infectious specimens) are used in the device (e.g.,
water, certain biological stains, paraffin sections). The laboratory
should consult the MSDS sheets that are received with the material to
determine proper handling requirements and safe use.
Ed Finkel is a writer in Evanston, Ill.