If you managed to
survive 2008, then you have a good start for 2009; it is more of the
same. With no major changes to CLIA regulations for the coming year, a
good idea might be to look at last year’s Top 3 violations as a review.
The No. 1 issue from 2008, according to CLIA, was
“SS493.1252 Standard: Test systems, equipment, instruments, reagents,
materials, and supplies. (b) The laboratory must define criteria for
those conditions that are essential for proper storage of reagents and
specimens, accurate and reliable test system operation, and test result
reporting. The criteria must be consistent with the manufacturer’s
instructions, if provided. These conditions must be monitored and
documented and, if applicable, include the following:
(b)(1) Water quality.
(b)(2) Temperature.
(b)(3) Humidity.
(b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports.”
In regular speak, that means maintenance logs,
not just temperature logs, but logs that also include humidity, water
quality, and surge protectors for sensitive analyzers. An important
point about the temperature log is that the range for each
supervised item must appear on the monitoring log (i.e., chemistry
refrigerator 4^0C to 8^0C). I have seen temperature logs with three full
weeks of the refrigerator temperature being logged in too high, and
either nobody noticed or no one knew what to do.
Key point: Have a solution to every potential
problem, and put it in your procedure manual. Also worth mentioning is
that many labs now — even POLs — are making their own reagent grade
water. How do you check the water purity? How often? And what if it
fails? Food for thought: Be sure to document these types of specifics in
your procedure manual as well.
Golden Rule
If you didn’t document it, then it didn’t happen;
If the lab director didn’t sign it, then it’s not true; and
My dog ate my temp logs is not a valid excuse.
The No. 2 violation for 2008 was SS493.1236
Standard: Evaluation of proficiency testing performance. (c)(1) Any test
or procedure it performs that is not included in subpart I of this part.
Interpretive Guidelines SS493.1236(c)(1)
Refer to subpart I, Proficiency Testing Programs
for Nonwaived Testing. Subpart I include those specialties,
subspecialties, and analytes that are considered regulated tests. For
those tests not listed in subpart I (not regulated), the laboratory must
verify the accuracy of the test or procedure twice annually.
Do not confuse “not regulated” with “waived.” Waived
tests do not require proficiency testing (PT), unless so stated by the
manufacturer. Though not required, PT is still a good idea. An example of a
not regulated test would be reticulocyte counts; this is not
waived. Find a PT supplier; or, as the regulation says, verify the
test’s or procedure’s accuracy twice annually. One recommendation would be
split-sample testing. Over six months, collect five samples; try to include
low, normal, and elevated results. Send them to a reference lab to compare
results. If they match with an established range (say, 10%) then continue
testing, and repeat every six months. If they do not match, stop testing;
there is a problem. When the error is corrected, continue testing. Now may
be a good time to find a provider for PT. Be sure to document all corrective
action in your procedure manual. Twice yearly verification (for tests not
listed in subpart I as requiring PT) may be done using purchased
quality-control (QC) materials as long as they come from a source other than
the daily QC.
And the final violation of the “Top 3” for 2008
is (drum roll) . . . SS493.1252 Standard: Test systems, equipment,
instruments, reagents, materials, and supplies:
a) Test systems must be selected by the
laboratory. The testing must be performed following the manufacturer’s
instructions and in a manner that provides test results within the
laboratory’s stated performance specifications for each test system as
determined under SS493.1253.
This could be tricky because it involves
following the manufacturer’s instructions, recommendations, suggestions,
and requirements in package inserts and/or instrument operator manuals.
These include, but are not limited to:
- handling reagents, materials, and supplies;
- adhering to conditions for storage and testing; and
- performing equipment maintenance and function checks.
The devil is in the details. In one instance, a
tech had done reproducibility checks many times. He started work at a
new lab doing his usual 10-sample reproducibility run. Turned out, that
particular analyzer called for a 20-sample reproducibility run.
The CLIA surveyor pointed out the error of his ways. When you sign off
on that yearly evaluation stating you have read and understand ALL
the procedures in the book, make sure you have actually read them.
Document this in your procedure manual.
These regulations may seem like a chore, but remember, the reason they are required is to ensure accurate patient results. Treat every sample as if it were your grandmother’s, and you will find it easier to take the time to do it right.
Tim “The Lab Guy” Dumas is a clinical laboratory scientist, manager, and consultant, and an accredited speaker through the National Speakers Association. He operates Tim Dumas Laboratory Consulting. Reach him through www.timdumas.com for information on his workshops.
