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 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 (Newletter), Building 102, 1413 Research Blvd, Rockville, MD 20850-6000. Electronic messages should be sent to martig@email.afip.osd.mil.

1997 CAP Contract

The 1997 College of American Pathologists Survey and Excel order booklets and forms will be mailed from CAP on or about 23 Sep 96. Orders are to be mailed or faxed back to this office NLT 24 October for inclusion in the central contracts. Validated materials, educational materials, and calibrators will continue to be self pay items for Army and Navy laboratories. The names and addresses of new sites seeking CAP accreditation must also be submitted at this time. Anticipate your needs so that the contracting process will be smooth.

Inspection Update

The following deficiencies are those most frequently cited by the College of American Pathologists during inspections of Army labs so far in 1996. (Includes phase level)

1-4150: Has the laboratory defined reagent grade water for each testing procedure? (II)
1-4165: Has the laboratory evaluated its water for silicates?(I)
1-7285: Are precautionary labels present on the containers of all hazardous chemicals, including type of hazard and what to do if accidental contact occurs? (II)
2-2000: Is there evidence of active review of records on controls, instrument maintenance and function, temperature, etc., for routine procedures on all shifts? (II)
2-2510: Are all timers in the hematology section checked at least semi-annually for accuracy? (II)
3-2110:Is there documentation of at least annual review of all procedures in the automated chemistry section by the current lab director or designee?(II)

A key item for any inspection is to ensure that you have no repeat findings. This is true for any of the inspections our laboratories are subject to. Look at the results from the last time the inspectors were there, along with your written plan of correction (you did do one, didn't you?), and make sure you have corrected those deficiencies.

New Waived Tests

The Centers for Disease Control and Prevention published a notice in the 8 July 1996 (Volume 61, Number 131) Federal Register in which the following test systems were added to the CLIA waived category.

HemoCue B-Glucose System (glucose), Hemocue, Inc;
Serim Pyloritek Test Kit (Helicobacter pylori)
Quidel QuickVue In-Line One Step Strep A Test (Streptococcus, group A)
Cholestech LDX Test System (total cholesterol, HDL cholesterol, triglycerides and glucose)
ChemTrak AccuMeter (glucose), ChemTrac, Inc
Johnson &John son ADVANCED CARE Cholesterol Test (cholesterol),
Boehringer Mannheim Accu-Chek InstantPlus Cholesterol (cholesterol)
SmithKline Gastrocult (gastric occult blood)
All Qualitative Color Comparison pH testing for body fluid (other than blood) pH

Bayer GLUCOMETER ENCORE+ Blood Glucose Meter (glucose)
An important point made by the CDC was that a test system/analyte combination (not a procedure or instrument) is categorized as waived. This means that only the kits indicated above are waived, not all Streptococcus group A or total/HDL tests. Also published in the July 8th Federal Register was the categorization of an additional 2400 laboratory test systems, assays and examinations by complexity. The CDC maintains an updated list of categorized tests electronically, available to the public via Internet. For information on this capability, call (770) 488-7655.

Fecal Occult Blood

The JCAHO recommends recording both patient test results and QC results in the patient chart for Fecal Occult Blood procedures. In order not to confuse the test result of positive or negative with the QC results, they recommend recording the QC results as "OK." If this procedure is followed, the JCAHO does not require a daily log for Fecal Occult Blood procedures.

CLIP Registration/ CLIP Certificates

As many of you have pointed out, the CLIP Manual states that registrations are valid for only 2 years and are not renewable. It was our intent to issue certificates indicating compliance with CLIP standards, but we experienced delays in the development and processing of these certificates. In the next 2 to 3 months, we will be issuing the following:
- Certificate of Accreditation for moderate/high complexity labs accreditated by CAP, JCAHO, etc.
- Certificate of Compliance for labs meeting CLIP standards but not accreditated by a "deemed status" organization.
- Certificate for Provider Performed Microscopy
- Certificate for Minimally Complex. In the meantime and IAW Subpart C, Section 493.45 (e) of the CLIP Manual, you can consider your registration to be extended and valid until such time as we issue you the new appropriate certificate(s).

PT Information

Whole Blood Glucose Surveys (WBG and WB2): When submitting glucose results from multiple Point of-Care testing sites, ensure you consistently use the same site designation for each clinic or ward (i.e. Emergency Room - Site "A", OB Clinic - Site "B", etc.) This is extremely important, as our evaluation of results is based upon the site designation since no other specific information appears on the survey summaries. The bottom line is, don't mix and match site designations, otherwise we might attribute failed testing events to the wrong POC area.

Associate Degrees - CLIA vs CLIP

All military laboratory technicians are subject to the same educational requirements as their civilian counterparts. Section 493.1489 of the 24 April 95 Federal Register states technicians performing high complexity testing must either earn an associate degree or successfully complete an official US Military medical laboratory training course of at least 50 weeks duration. Additionally, Section 493.1461 states graduates of military medical laboratory training courses meet requirements as general supervisors if they have at least two years of clinical laboratory training or experience, or both, in high complexity testing either before or after completion of training. The 24 April '95 publication contains other alternative qualification pathways and "grandfathering" clauses with equal application in the civilian and military medical settings. If testing personnel and general supervisors meet equivalency requirements, there is no federal mandate to obtain the associate degree to work in either military or civilian laboratories. Additionally, those graduating from military training courses after 24 Apr '95 will receive 60 semester credit hours and associate degree equivalency. Anyone meeting equivalency requirements is very close to obtaining an associate degree and should be encouraged to complete the requirements.

OCLAB Sources

We are attempting to place this bulletin on the AFIP home page at: http://www.afip.mil and on the Air Force Lab Bulletin Board at 1-800-257-USAF. Our office has moved within the Washington D.C. area. We are now located in Rockville, MD. The address is:

AFIP/ZD - OCLA
Building 102
1413 Research Blvd
Rockville, MD 20850-6000.

Tips on Surveys

Here are some tips for reducing survey failures due to various problems.
- Strictly follow CAP's (or other PT provider's) storage and handling requirements prior to testing your survey materials.
- Analyze the survey specimens within the time frame provided for by CAP (or other PT provider). DO NOT let them sit around in the lab.
- Use a volumetric pipette, rather than syringe, to reconstitute lyophilized survey specimens.
- Be aware of clerical errors when filling out survey answer sheets. Watch where you put your answers.
- Identify the instrument or method you used correctly on the answer sheet so that your peer group results are correct.
- Keep a copy of the submitted survey sheets (this is very important to aid in corrective action if clerical error is suspected).

Provider Performed Microscopy

There have been numerous questions on the updates to the rules on PPM and on the rules themselves. This catagory was originally for physician performed procedures. It was updated last year to include nurse practitioners, nurse midwives, physician assistants, podiatrists and dentists. Other personnel (i.e. RNs) may continue to perform these same tests - but must register for a moderate complexity certificate. Along with the moderate complexity certificate goes the QC and proficiencty testing requirements. In some cases, one location may require two certificates to cover all testing personnel. An example if this is an OB-GYN ward with clinical nurses expected to perform Fern tests. Clinical nurses perform Fern tests under a moderate certificate while physicians perform the same test under the PPM certificate. If only a single certificate is requested for this example, it must be for a moderate complexity lab. Under a single certificate, all providers, to include physicians, nurse practitioners, nurse midwives and physician assistants perform these procedures in accordance with the requirements for moderate complexity testing. The decision on how to register (which certificates to obtain) in these situations belongs to the laboratory director. The only requirement is that testing be performed in accordance with whatever complexity the certificate is obtained. It should also be emphasized that only those tests specifically identified as PPM or waived can be applied for under a PPM or waived certificate. All other tests are moderate or high complexity and the appropriate certificate must be obtained.

Cytology Issues

CLIA 88 (42 CFR §493.1257(b)) and CLIP (Sec K, para 493.1257(b)) require that each individual evaluating cytology preparations by non automated microscopic techniques examine no more than 100 slides (one patient per slide) in a 24-hour period, irrespective of the site or laboratory. This total can be examined in no less than an 8 hour period and the 100 slide limit does not include previously examined slides. The laboratory director must maintain records of the total number of slides examined by each individual, irrespective of the site or laboratory, in each 24-hour period and the number of hours each individual spends examining slides in each 24 hour period. To avoid a potential problem in your laboratory, ensure cytotechnologists who are engaged in off-duty employment do not exceed this limit and that you have records of the number of slides screened and hours spent at the other jobs.

Government Web Sites

CDC MMWR: http://www.cdc.gov/epo/mmwr/mmwr.html
Dept of Health and Human Services: http://www.os.dhhs.gov
Federal Register: http://www.access.gpo.gov/su_docs/aces/aaces002.html
FedWorld: http://fedworld.gov
FDA: http://www.fda.gov/fdahomepage.html
HCFA: http://www.hcfa.gov
Library of Congress: http://lcweb.loc.gov
OSHA: http://www.osha.gov
US House of Representatives: http://www.whitehouse.gov
White House: http://www.whitehouse.gov

New OCLA Phone Numbers

Army COL Martig 301-319-0133 SFC Miller 301-319-0733

Navy CDR MANN 301-319-0132 HMC Callahan 301-319-0074

Air Force Col Warnken 301-319-0134 SMSgt Barnard 301-319-0072

FAX 301-319
DSN prefix 285

AFIP Home Page

OCLAB