ASK THE EXPERT
Barry Craig, MLT (NCA), CLC
Lab Coordinator, CHS
Member POCCA (Point of Care Coordinators Alabama)
Member Helena Laboratories Focus Group
I
am having trouble contacting the state
CLIA office for where I live. Is there a list
or something with this info?
I just looked on the wall in the lab and our
Certificate of Waiver has expired! What do we
do now? Are we in trouble?
Yes there is. Here is the link to the CLIA
contact database. It lists all the state
agencies for CLIA and their contact info including
addresses, phone numbers and emails.
First, the government goon squad is not
going to break down your door and start
shooting (unless it’s related to tax evasion, then
the IRS will break the door down).
Stop testing immediately. You cannot test
without a valid license. Contact your state CLIA
office (see the link above) and find out if they
can resend your payment coupon or if you will
need to apply again from scratch. Regardless of
what they say, NO TESTING CAN BE PERFORMED
until you pay for and receive your new license.
Also, any testing performed while the certificate
was expired is subject to having the
reimbursement taken back.
http://www.cms.gov/Regulations-and-Guidance/
Legislation/CLIA/Downloads/CLIASA.pdf
Who is required to review and sign off on the
controls, calibrations, etc. that are produced
by the lab? If the tech that runs the
instrument signs off, is that sufficient?
For all non-waived labs, it is required to have
someone listed as either technical consultant
(moderate complexity) or technical supervisor and
general supervisor (high complexity). These
positions should review all documentation
produced by the lab. If the Lab Director fills more
than one role and also serves in one of these roles,
then they must review and sign off on these records.
We have had a rash of bad needles lately from
a manufacturer we normally do not order
from. These are snapping off at the hub when
we use them. I am afraid one of patients is
going to get hurt. What steps do I take to
report this problem?
The laboratory inspector cited us for not
having a “traceable” thermometer for our
refrigerator. What does this mean?
The FDA has a program called MedWatch
3500, which a reporting mechanism for any
medical device that can cause injury or death
to a patient.
Use the MedWatch form to report adverse
events that you observe or suspect for human
medical products, including serious drug side
effects, product use errors, product quality
problems, and therapeutic failures for:
• Prescription or over-the-counter medicines,
as well as medicines administered...
Traceable refers to NIST traceable. This means the
thermometer is certified to be accurate and comes
with a certificate of accuracy from the National
Institute of Standards and Technology (NIST). The
thermometer will have an expiration date on the
back. After the date listed, the thermometer is
no longer considered accurate to NIST standards
and must be sent in for recertification.
Check the POR magazine website to see if these
are available through one of their advertisers.
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