Originally published in CAP TODAY
Though the intended response is to cite a deficiency, the
supervisor's response "actually makes some sense," Dr. Ruhlen
admits. "Our checklist commissioner sent a very similar scenario
to all the regional commissioners and asked, 'How would you
handle this situation?' The results were pretty interesting
because there was significant variation in the way commissioners
handle it. Many said, 'No, it doesn't meet the requirements
of the checklist,' but there were quite a few that said, 'When
we think about it, we can't see why that's not valid.'"
Quality control continues to evolve, and some longstanding
guidelines tend to reflect tradition more than science. "The
technology has got to the point where some of those old quality
control rules [might not] apply. This is one of those examples
where maybe you don't need to have a negative control with some
of these tests," says Dr. Ruhlen.
The Commission on Laboratory Accreditation, however, has not
yet reached that conclusion. Unless that checklist question
is changed, the laboratory in scenario No. 4 is considered to
be not in compliance with the current Standard.
This scenario is further complicated because the two relevant
questions in the proposed checklist are significantly different
from existing Immunology & Syphilis Serology Checklist question
06: 3430. Once the proposed checklists, which have been approved
by the Commission on Laboratory Accreditation, are approved
by the Health Care Financing Administration, they can be used
in the field for inspections. (The proposed checklists are available
on the CAP Web site.
"Currently we're using checklists that are two-plus years
old for the actual inspection," Dr. Ruhlen says. "But if a laboratory
protests when it gets cited on something, then we refer to the
proposed checklist. If what's in the proposed checklist is more
lenient than what's currently in the field, then we go ahead
with what's in the proposed checklist. If what's in the proposed
checklist is more stringent, then we stay with what's currently
in the field."
The current immunology checklist question that refers to direct
antigen testing QC asks, "Are known positive and negative controls
run on each day of analysis with each run of specimens for all
qualitative or semi-quantitative serologic tests (e.g., rheumatoid
factor, rapid plasma reagin, ASO, hCG, heterophile antibody,
etc.)?" As such, it doesn't distinguish between those tests
that have built-in controls and those that don't.
The proposed immunology checklist replaces this question with
two new ones that make this distinction. They are: "For tests
that do not include built-in positive and negative controls,
are known positive and negative controls tested on each day
of analysis for all qualitative or semi-quantitative antigen/antibody
tests (e.g. rheumatoid factor, rapid plasma reagin, ASO, hCG,
heterophile antibody)?" and "For tests that do include built-in
positive and negative controls, is a positive and negative external
control tested with each new kit lot number or different shipment
of a given lot number for all qualitative or semi-quantitative
antigen-antibody tests (e.g. rheumatoid factor, rapid plasma
reagin, ASO, hCG, heterophile antibody, etc.)?"
"The proposed checklist simply clarifies the requirements-it
doesn't change them," says Dr. Ruhlen. If a test kit does not
include built-in controls, then external positive and negative
controls need to be run each day of use. If the test kit includes
built-in controls, then external positive and negative controls
need to be run only with each new test kit. These internal controls,
however, are sufficient only if the test system has been classified
as a waived or unmodified moderate-complexity test under the
Clinical Laboratory Improvement Amendments of 1988. In addition,
the manufacturer's recommendations must be followed.
This scenario involves review of a laboratory's immunology section
documentation of new reagent testing for the lab's infectious
mononucleosis kits. To parallel test new kits, the laboratory
runs known positive and negative patient specimens from the previous
day using reagents from the new kit.
In this case, the laboratory's procedure is considered an
acceptable practice and should not be cited.
The Immunology & Syphilis Serology Checklist question that
addresses this is 06:3315: "Are new reagent lots checked against
old reagent lots or with suitable reference material before
or concurrently with being placed in service?"
Laboratories sometimes don't run a parallel check. "When the
old reagents expire, they simply start using the new reagents,"
says Dr. Ruhlen. "Another common problem is that laboratories
do the parallel testing, but their documentation is weak or
Furthermore, laboratories often take the controls from an
old kit and test them using the reagents from a new kit. "The
controls may have what we call lot specificity, meaning the
reaction has something to do with the manufacturer's lot that
it's from," Dr. Ruhlen says. "So you're making a possibly invalid
assumption that control material is going to react just like
patient material. The ideal is to test patient samples or some
kind of reference material that you know is going to act like
a patient sample."
To address these problems, laboratories should run parallel
tests with known patient samples, as in scenario No. 5, or with
reference material that gives positive and negative results.
They also should use a separate log sheet to document this process.
"The idea is that before you start using the new kit, while
you're still using the old kit, you'll run those kits side-by-side,"
says Dr. Ruhlen. "So you can test patients using the old kit
and report it off the old kit, but run the test with the new
kit to be sure you're getting the same answers."
Laboratory inspectors sometimes misinterpret this checklist
question, requiring laboratories to run parallel tests with
both patient specimens and reference materials when either alone
A laboratory's temperature and maintenance records for a chemistry
instrument are initialed and dated by the section supervisor each
month. However, there is no evidence of a weekly review.
That's acceptable, says Dr. Ruhlen, and thus the laboratory
should not be cited. "The current checklists in the field do
state a requirement for weekly review by a supervisor and then
monthly review by the laboratory director or designee," he explains.
"But the Commission on Laboratory Accreditation recently approved
a change in the proposed checklist that requires monthly review
by the laboratory director or designee. Any more frequent review
is up to the discretion of the laboratory director."
Automated/General Chemistry Checklist question 03:2010, which
also appears in many of the other checklists, asks, "Is there
evidence of active review of results of instrument maintenance
and function, temperature, etc., for routine procedures on all
Inspectors commonly find that laboratories fail to include
the temperature and instrument maintenance records as part of
their QC review. Another problem is that documentation of this
review is sometimes incomplete, and some laboratories forget
to complete the review every month. We've found that some laboratories
are "keeping temperature records on their refrigerators and
their heating blocks, but no one looks at them," adds Dr. Ruhlen.
To resolve these problems, instrument maintenance and temperature
records should be included in QC review; a laboratory director's
approval for a designee to perform this review must be documented;
the scope and frequency of a laboratory's QC review should be
described in its QC plan; and laboratories should diligently
carry out these reviews as prescribed.
& 8. In this scenario, the chemistry section's
procedure manuals are written in the NCCLS' format. While the
first page of each procedure includes evidence that an annual
review has been conducted by the chemistry supervisor, the laboratory
director's signature is not on any of the procedures.
If the laboratory director has documented the delegation of this function,
the inspector should not cite a deficiency, Dr. Ruhlen says.
two Automated/General Chemistry Checklist questions that address
this scenario are 03:2100 and 03:2110: "Is a complete procedure
manual available at the workbench or in the work area?" and "Is
there documentation of at least annual review of all policies and
procedures in the automated chemistry laboratory section by the
current laboratory director or designee?"
"We see a whole variety of problems with procedure manuals that
constantly come up," says Dr. Ruhlen. "Sometimes the procedures
are nonexistent or woefully out of date, or they're not complete
or detailed enough. Sometimes we see manufacturers' inserts being
used without any kind of modifications to make them specific for
the laboratory. Sometimes the manuals aren't available in the work
area-they're put somewhere in a supervisor's office, well away from
the workbench. Sometimes work cards are in place that don't correlate
with the procedures as outlined in the procedure manual. Annual
review documentation is a problem. And then sometimes we see problems
with the use of electronic manuals."
Here's what Dr. Ruhlen suggests laboratories do to comply with
- Write the procedures in the NCCLS' format. That means they must
include statements on the test's principle, clinical significance,
specimen type, required reagents, calibration, quality control,
procedural steps, calculations, reference ranges, and interpretation.
- Tailor manufacturers' inserts and manuals to meet the specifics
of the laboratory. This includes information on controls, reporting
instructions, reflexive testing, critical values, and reportable
- Keep current manuals in the work area and keep work cards up-to-date.
- Follow the checklist requirements for documenting the annual
procedure manual. "There's basically two ways to go about this,"
says Dr. Ruhlen. "One is to date and sign each procedure either
on the first page or the last page of the procedure, or the alternative
is to date and sign each procedure in the table of contents. It's
not acceptable to have a single page at the beginning of a procedure
manual that says, 'All the procedures in this manual have been
reviewed, dated, and signed.'"
- If electronic manuals are used, keep records that document annual
reviews and specify who is authorized to make changes.
- Ensuring the laboratory meets these requirements and reviews
the resulting procedure manuals annually is a logistical problem,
Dr. Ruhlen admits. "We have lots of procedures and they come and
go," he says, "so it's always an ongoing problem. That's why procedure
manuals are one of the most common deficiencies."
Vida Foubister is a freelance writer in Chicago.