Office
of Clinical Laboratory Affairs Bulletin
NEWS AND VIEWS FROM THE
REGULATORY SCENE
CAP Contract Time
The time to renew your CAP
Proficiency Testing Contract will be here very soon. Please email your
facility's CAP representative's name, phone number, fax number and email address
to your service representative, ASAP. Now is also the time to look at which
surveys you actually need. By mid-year it is often difficult to arrange for
needed surveys. Additionally, if certain procedures are no longer performed,
please advise us so that we can cancel the survey and save the dollars. Remember
to put your CLIP number on the order form in the block marked CLIA Number. The
numbers are equivalent and this will identify you as a DoD lab so that your PT
results will be routed correctly.
We have been advised that a few
laboratories have contacted CAP directly to request changes to their PT
contract. Please use your service representative to make all changes. This is
the only way to ensure that we are getting what we pay for. When you ask us to
change your PT survey order, be certain which surveys you want added or deleted.
Some surveys have similar names but each code is unique.
PT Grading Policy Changes
The Clinical
Laboratory Improvement Advisory Committee (CLIAC) adopted two policy changes
that affect how your PT will be graded. First, each test will be graded
individually rather than combining two or more procedures and grading them as a
group. For example the Bacteriology survey’s Gram stain, ID and
sensitivity will be graded as three separate tests rather than as a single
procedure. Second, the distinction between Regulated and Unregulated analytes
will be removed. Passing grades on PT surveys with 5 challenges will
require 4 correct, 4 challenges will require 3 correct, 3 or fewer challenges
will require all to be correct. The 100% correct requirement for certain
Blood Bank analytes will remain unchanged.
Updating Current CLIP Registration
Remember
to update your CLIP registration information when your laboratory changes
directors or changes complexity. This can be accomplished by fax, email or
regular mail. The OCLA fax number, email and snail mail addresses for your OCLA
POC are listed at the end of this bulletin.
Renewing CLIP Certificate
Your CLIP
certificate is valid for no more than two years. Apply to OCLA for renewal of
your certificate before the certificate expires. When submitting an
application for renewal include verification of the lab’s compliance with the
provisions of the CLIP. Acceptable verification is either a copy of the
current letter from CAP, JCAHO or COLA granting accreditation or a statement of
compliance with the provisions of the CLIP from the facility commander or
designee. Once created an example of the statement of compliance will be
posted on the OCLA webpage.
Point of Care Testing Sites (POCT)
The term
POCT is used for testing that is performed outside of the laboratory, typically
at the patient’s bedside. The location is the only thing that POCT
denotes. POCT procedures can be minimal, moderate or high complexity and
need to comply with the regulatory requirements for that level of testing.
CLIA maintains test complexity files that include methods and their assigned
complexities. These files can be reached from the OCLA Website at
http://www.afip.org/OCLAB/ocladocs.html. Each site needs to have a current
CLIP Certificate and perform PT. Do not assume that all Point of Care
Tests are minimal complexity. Properly identify the complexity level of your
POCT and assure that compliance is being met to maintain the appropriate CLIP
certificate.
POCT Accreditation Q&A
Many labs have
come up against the question of Documentation of Competency on Physicians
performing procedures that are within their scope of practice (i.e., Family
Practice Doctors performing KOH wet preps).
CAP QUESTION: 30:0670 PHASE: II, Is there evidence that the person(s) performing the tests have adequate, specific training and orientation to perform the tests offered?
CAP RESPONSE: Regarding documentation of competency and employee credentials - It is the responsibility of the institution to determine what “a satisfactory level of competence” is and how this will be ascertained and documented. This item applies to each person doing the testing, but again, it is the responsibility of the institution to determine how education, experience and the type of testing being performed is evaluated.
JCAHO RESPONSE: Physicians performing testing procedures that are within their scope of practice (i.e., Family Practice Doctors performing KOH wet preps) may be considered “competent” by virtue of their credentialing process if so stated in facility policies. NOTE: Nurses Practitioners, Physicians Assistants, Etc. MUST have documentation of competency.
NOTE: These responses do not mean that Proficiency Testing is optional. For facilities performing screening tests where positive or negative results or a presumptive result are reported (i.e., Germ-tube for Candida or growth/no growth on Neisseria selective media) HCFA states that if a clinician is treating a patient based on the results of this type of test, you must be doing PT at the same level that you are reporting results. Check your clinics and either stop doing the test or order the appropriate PT survey.
Army
LTC Kneisel 301-319-0133 SSG Rodriguez 301-319-0073 |
Navy
CAPT Craigmiles 301-319-0132 HMC Lahl 301=319-0074 |
Air Force
Col Brown 301-319-0134 SMSgt Williams 301-319-0072 |
WebPage: Copies of this bulletin and all previous OCLAB editions, CLIP
certificate applications with appendices, the CLIP manual (AFIP Pam 40-24 dated
8 July 1996) and other information can be found at the OCLA webpage.
http://www.afip.org/OCLAB/oclab.html
AFIP Home Page | OCLAB |