Vol 5 No 1
Sept 2000


Office of Clinical Laboratory Affairs Bulletin


NEWS AND VIEWS FROM THE REGULATORY SCENE

Statement of Ownership: OCLAB is an unofficial publication of the Office of Clinical Laboratory Affairs (OCLA). It is published on a periodic basis.   The purpose is to furnish timely information on policy, activities and programs relevant to compliance with the Clinical Laboratory Improvement Program (CLIP). Distribution is to all registered laboratories and Quality Management Offices in the medical treatment facilities. The views expressed are not necessarily those of the Department of Defense, or the Departments of Army, Navy or Air Force. Comments on proposed topics or content should be sent to: Office of Clinical Laboratory Affairs, ATTN: AFIP-ZD(Newsletter), 1413 Research Blvd, Building 102, Rockville, MD 20850-6000. Electronic messages should be sent to lahl@afip.osd.mil. 

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.


OCLA Phone Numbers / Address
Army

LTC Kneisel 301-319-0133

kneisel@afip.osd.mil

SSG Rodriguez 301-319-0073

rodriguezr@afip.osd.mil

Navy

CAPT Craigmiles 301-319-0132

craigmilesR@afip.osd.mil

HMC Lahl 301=319-0074

lahl@afip.osd.mil

Air Force

Col Brown 301-319-0134

brownd@afip.osd.mil

SMSgt Williams 301-319-0072

mailto:williamcd@afip.osd.mil

FAX 301-319-3538 / DSN Prefix 285
AFIP-ZD/OCLA, 1413 Research Blvd, Bldg 102, Rockville MD 20850-6000

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


Published 20 October 2000 * Comments or suggestions on content contact: Maj Mapp (mappb@afip.osd.mil)
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