I used to assume that all these little,
easy-to-use, no mistakes, “anyone can do it” lab kits were all waived
for all patients. Not so. I recently had a situation in which a
pediatric office lab was not happy with the performance of its
mononucleosis kit test and inquired as to the availability of other such
kits.
Their medical supplier informed me about the many
other kits available and clarified that the kit the lab was using was
his only waived “mono” kit approved for pediatric use. He had another
that was similar, previously a waived method, but the manufacturer had
neglected to apply for pediatric-waived status. So, now the test was
categorized a non-waived
procedure for children under 18 and waived
for adults. This does not mean the test cannot be used for pediatrics,
only that it is not waived for pediatric testing. The Food and Drug
Administration is very specific as to which part of the population the
waived status applies. For the pediatric office to use this kit to test
children, the lab would be placed into a non-waived (moderately complex)
class, and staff would have to do a performance verification. No, I am
not kidding.
Sales reps provide a new sample test kit for labs
to try.
Beware — and Be Sure — that the test is
waived for your patient population. If you would like to try a
non-waived kit, remember CLIA regulations require a lab to verify the
reliability of every non-waived test introduced. You would need to run
performance verification. Performance verification is easy enough, but
it must be completed and documented before the test can be used to
report patient results. Most kit tests are qualitative, meaning the
results are usually positive or negative, reactive or non-reactive. So,
documentation and review of patient sampling is much simpler than
quantitative. [If you need more info on quantitative performance
verification, go to: 1)
www.cdc.gov/clia/regs/subpart_k.aspx#493.1253; 2)
www.clsi.org; and/or COLA's online course, “Verification of
Performance Specification.”]
When performing verification, be sure to follow the manufacturer's instruction for testing procedures and use the proper sample — whole blood vs. serum. The package insert may even include a procedure for verification. You will need to have a known sample — a sample that has previously been tested and verified to be positive or negative. You can either purchase these as controls, or you can utilize patient samples that have been previously analyzed by a reference lab. Here is an abbreviated procedure for qualitative performance verification: 1) Perform the test on two known positive samples; document results; 2) perform the test on two known negative samples; document results; 3) confirm that your results were as expected; and 4) have the results and documentation confirmed and signed by the lab director.
Place the documentation in your procedures
manual, along with the procedure, and retain for two years after the
test is discontinued. Your procedure manual must list all procedures,
even the ones that were only used for a short while. Do not forget that
CLIA requires an annual review of all procedures, including waived
testing.
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,
or for information on his professional workshops, use
www.advancepoc.com.
Safety never takes a vacation. It is an integral part
of the lab's operations — but one we often take for granted. For example, do
you wear gloves when you perform lab tests? Of course, you reply. But do you
remember that the gloves must be pulled on over the outside of the lab coat
cuff so no skin is exposed? Do you remove them aseptically? Do you take them
off before you remove your lab coat? This may sound routine, but I can
assure you that many laboratorians have no idea about the proper lab-safety
etiquette that keeps them from harm.
Lab coats are another safety issue. They should be
knee length and have arms long enough for even the tallest person. Employees
wear lab coats; but when one of them has to reach for something on a high
shelf, the sleeve pulls back from the gloves and skin is exposed. That
person then may neglect to pull the sleeve down and adjust the gloves once
again over the cuff. If the sleeves were long enough in the first place,
this would not be an issue. Antistatic buildup with polyester fabric is
another problem for lab coats. Be sure your coats have an antistatic thread
within the fabric to prevent static electricity from building and
potentially causing equipment or computer failure due to electrical
discharge. This includes disposable as well as reusable coats.
Safety needles have been required since 2001. The
safety feature is there to protect employees from needlesticks. Do you
activate the safety feature after you remove the needle from the patient?
OSHA checks sharps containers and counts the inactivated safety needles,
fining facilities up to $2,000 per inactivated needle. That can get
costly in a short period of time.
Blood-culture bottles made of glass are another
cause for concern. These can break or crack, causing exposure at any
number of points along the process. In the past few years, plastic
bottles have become a source of safety as well as being cost effective,
both upstream with ergonomic issues such as weight to move and lift, and
downstream with the cost of disposal, which is also charged by weight.
Then, there is the matter of biohazard waste. Are
you putting this waste into a bag with the biohazard symbol? Do you use
a reusable or disposable system? Do the containers have lids on them?
Some counties require that red-bag waste containers have the lids on
them at all times except when placing items into the containers. Waste
management is not only the responsibility of the laboratory but also
often impacts other departments such as housekeeping and facilities
engineering.
Labs also must comply with local and state
regulations. The Clinical Laboratory Standards Institute is revising its
GP5 document on waste management, a standard that will be comprehensive
and in line with current practices and regulations within 18 months.
Always utilize the latest safety measures in your
laboratory to protect employees from harm. Remember, safety never takes
a vacation.
Best-selling author, professional speaker,
and safety consultant Terry Jo Gile, The Safety Lady, has helped
thousands of laboratorians create safety-savvy laboratories. Her book,
Complete Guide to Laboratory Safety – 2nd ed., is the consummate safety
reference tool specific to clinical labs. Contact her at
www.safetylady.com.
