Office of Clinical Laboratory Affairs Bulletin
Office of Clinical Laboratory Affairs Bulletin
Statement of Ownership. OCLAB is an unofficial publication of the Office of Clinical Laboratory Affairs (OCLA). It is published on an irregular basis (hopefully 4 times per year). 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 martig@afip.osd.mil.
Update Your 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 is (301) 319-3538 or DSN 285. Email should be directed to your serviceís enlisted representative.
Personnel Changes at CLIP Office
There have been several changes to the personnel at the CLIP office due to retirements and changes of station. HMC Cecilia Callahan retired from the Navy on 12 June and was replaced by HMC Dennis Lahl. SFC Valerie Miller retired from the Army on 26 June and was replaced by SSG Pheobe Brown. The new emails that have been set up are lahl@afip.osd.mil and brownp@afip.osd.mil. CDR Robert Mann, the Navy officer representative to the CLIP Office, has also decided to retire effective 6 October 1998. He has accepted a position with the Kaiser Health Care System as the Regional Laboratory Manager for the Mid-Atlantic States Region. His position will be filled by CAPT Michael Brophy. Additionally, COL Martig, the Army representative to the CLIP Office, will be retiring the middle of November. He has accepted a position as the Surveys Division Manager for COLA. His position will be filled by COL Richard Brown. Contact SSG Brown for information on contacting COL Brown.
EMAIL changes for CLIP Office
AFIP has migrated its servers to Microsoft Exchange, which necessitated a change in email clients. This resulted in a change in our email addresses. The only change is that the "email" portion of our address has been dropped. So instead of xxxx@email.afip.osd.mil, the new address is xxxx@afip.osd.mil. Please continue to email, call or fax us with any questions, lab changes, or issues that you might have. NOTE: The email for SMSgt Williams is williacd@afip.osd.mil.
Communicating with OCLA
Please take a few moments to send us your current phone numbers and email addresses. It seems that many have changed this past year and we are having a difficult time contacting your lab when we need to. You can email or fax them to us. FAX # (301) 319-3538.
CAP Contract time
Contracting time begins very shortly. Please email your facilityís CAP representative's name, phone number, fax number and email address to your service representative, ASAP. Let's be on the ball and make the process simpler. Now is also the time to begin looking at which surveys you actually need. By mid year it is often too late to procure needed surveys. Additionally, if you no longer perform certain procedures, please cancel the survey and save the money. Despite what CAP says in the letter accompanying the order form, put your CLIP number on the order form in the block marked CLIA Number. The numbers are equivalent and this will mark you as a DoD lab so we will get your PT results. This will help us resolve several issues. Thanks.
It has come to our attention that laboratories are going directly to CAP to make changes to their proficiency-testing contract. Please use your service representative to make the changes. This is the only way we can make sure we are getting what we pay for. When you contact us to make changes in your PT survey order, be sure to tell us exactly what surveys you want added or deleted. Some surveys have similar names but different codes.
Laboratory Changes
Consolidating laboratories or shutting some down? You need to inform your accrediting organization (CAP/JCAHO/COLA) IN WRITING about the changes along with notifying us. We will make the changes on your CLIP certificate, but the notification of CAP/JCAHO/COLA affects your accreditation status. Very Important!!
JCAHO Survey Issues
The Joint Commission has been surveying more military laboratories (mainly those in health clinics) this past year and they seem to be concentrating on a few items. Proficiency Testing, Leadership and Quality Assurance are the areas that seem to be showing up frequently. The Leadership issues fall into two areas. The first deals with the role of the director in the laboratory daily activities. The director needs to have documentation that he/she is actively involved in the laboratoryís provision of health care. If the director is not a pathologist, then the consulting pathologist needs to show that he/she really acts like a consulting pathologist. The second area overlaps into proficiency testing. When a lab section or outlying clinic is having trouble with PT, the main laboratory leadership needs to show that they have taken a proactive role in correcting the problems. Again, documentation is required for all actions taken. In regards to proficiency testing, each lab needs to make sure it has a PT survey for each test that it reports results for. The lab also needs to ensure that it participates in each survey event. The JCAHO survey question regarding PT is Yes or NO on active participation. Not participating in survey events can earn your lab a 5 for that question. The Quality Assurance issues are the same as those that have repeatedly come up during CAP inspections. Each laboratory must have a written QA plan that covers all sections and areas of the laboratoryís operation, and the laboratory must follow the plan. Document what you do regarding QA issues and actions.
Oversight of PPM / Minimally Complex Sites
Laboratory directors need to be aware of their accrediting organizationís requirements regarding oversight of PPM and Minimally Complex laboratories. While these types of laboratories are not separately accredited, they are looked at as part of an organizationís overall provision of health care. The laboratory directorís responsibilities include ensuring the proper training of testing personnel, competency assessment, documentation and QC review. Check your accrediting organizationís survey manual for specific requirements.
Lab Director Info
The CLIP regulations were changed earlier this year to bring the military into closer compliance with CLIA regulations. A qualified individual can only be the laboratory director for 5 moderate or high complexity laboratories. This includes PPM sites, as they are a subset of moderate complexity tests.
Screening Tests and PT
Do any of your clinic laboratories perform a screening test 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 says 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.
AF Medical Genetics Center
Weíre now on-line! Weíve put together a web site that is not only user-friendly but offers "real" content. You can not only view current genetics test information, but you can print our CAP and CLIP certificates. You can also print/download our latest test request form and scan through recent and past issues of our newsletter.
http://81mdg06.keesler.af.mil/information/mdos/flights/Genetics/index.htm
OCLA Phone Numbers / Address
Army COL Martig 301-319-0133 SSG Brown 301-319-0073 |
Navy CAPT Brophy 301-319-0132 HMC Lahl 301=319-0074 |
Air Force Col Warnken 301-319-0134 SMSgt Williams 301-319-0072 |
AFIP-ZD/OCLA, 1413 Research Blvd, Bldg 102, Rockville MD 20850-6000
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