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@email.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 service's enlisted representative.
Most Common Lab Deficiencies
A survey conducted by Medical Laboratory Observer during the last half of 1997 revealed the most common deficiencies noted during accreditation surveys. Leading the list was improper documentation; followed by inadequate procedure manuals and/or procedure issues in general; inadequate QA/QC programs; inadequate utilities/equipment; and insufficient space. Do these sound familiar? Have they shown up on you inspection reports? Take time now to review the documentation in all aspects of your laboratory operation as well as reviewing your QA program to ensure it meets CLIP and your accrediting body requirements.
Changes to the CLIP Regulations
The changes listed below have been made to the 8 July 1996 AFIP Pamphlet 40-24, Department of Defense Clinical Laboratory Improvement Program. These changes were requested by the Department of Health and Human Services as part of the extension of the Memorandum of Agreement between HHS and DoD regarding the Clinical Laboratory Improvement Amendments of 1988. These changes have been mailed to all CLIP registered labs so that the change sheet can be filed with AFIP Pamphlet 40-24. Each lab should have a complete and current copy of the CLIP regulations in the laboratory.
Page 6, Section 2-4a; page 7, Section 2-4b(4); page 53, Section 10-1a(2). Add the following sentence at the end of the paragraph: "The DoD CLIAC will coordinate with/notify HCFA and CDC for all modifications made to CLIA regulations."
Page 14, Section 3-3. Change the CLIA regulation citation from 493.37 to 493.39.
Page 19, Section 4-5c. Change OASD(HA) to TSG.
Page 23. Section 5-3b. Add the following two paragraphs:
(6) Authorize the accreditation program to release to TSG the laboratoryís inspection findings whenever TSG conducts random sample or complaint inspections; and
(7) Authorized its accreditation program to submit to TSG the results of the laboratoryís proficiency testing.
Page 33. Section 6-9d. Change Antibody detection (493.865) to antibody identification (493.865).
Page 35. Section 7-1. Change the sentence "DoD as an entity ..." at the end to read "military unique circumstances (which will be limited to overseas laboratories)."
Page 35. Section 7-2. The first line should read: "The proficiency testing program must (if there are any DoD users of the specific proficiency testing program):
Page 36. Section 7-2f. Delete "if there are any DoD users of the specific proficiency testing program"from the first line.
Page 42. Section 8-7b. Change the acceptable performance for IgG from +/- 3 SD to +/- 25%.
Page 48. Section 9-3. Add the following sentence after the second sentence in the opening paragraph: "The laboratory must make an attempt to obtain written authorization for oral requests."
Page 51. Section 9-6. Change second line ... valid certificate ... to read ... valid CLIA/CLIP certificate .
Page 51. Section 9-6d. Change first sentence to read "as determined by the area medical commander" instead of "as determined by the local commander or the TSG."
Page 53. Section 10-1. Change CLIA reference from 493-1107 to 493-1201.
Page 53. Section 10-2 and Section 10-3. Change "1 September 1996" dates to July 1998.
Page 65. Section 10-13. Change 10th line from "revocation of CLIA certification" to "revocation of CLIP certification".
Page 83. Section 11-5a and page 86 Section 11-11d. Change "direct no more than eight laboratories" to "direct no more than five laboratories".
Page 94. Section 11-22b(3)(b). Change "October 1996" to July 1998 (both references).
Page 113. Section 11-38d. Change "1 September 1992" to "1 September 1994".
Page 113. Section 11-38e. Change "1 September 1993" to "1 September 1994" and "1 September 1994" to "1 September 1995".
Page 114. Section 11-41.b. The subparagraph has been renumbered and two words added:
b. Have met 1 of the following associate degree or equivalency requirements:
(1) Earned an associate degree in lab science or medical lab technology
(2) Have education and training equivalent to that ... includes both:
(a) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either
(1) 24 semester hours of medical lab technology courses, or
(2) 24 semester hours of science courses that include 6 semester hours of chemistry, ...
(b) Have laboratory training that includes either:
(1) Completion of clinical laboratory training program ... or
(2) Minimum 3 months documented laboratory training in each specialty ...
OCLA Office Changes
The new Air Force enlisted representative in the OCLA office is SMSgt Catherine
Williams. She can be reached at the phone number and email shown below.
OCLA Phone Numbers / Address
Army COL Martig 301-319-0133 SFC Miller 301-319-0073 millerv@email.afip.osd.mil |
Navy CDR Mann 301-319-0132 HMC Callahan 301=319-0074 callahan@email.afip.osd.mil |
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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