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.
Clinical Laboratory Improvement Advisory Council
The DoD Clinical Laboratory Ad-visory Council (CLIAC) met for the first time on 24 Jan 96. The council is chaired by the DOD Health Affairs representative. Members are the Pathology consultant/ advisor for each Service, the laboratory consultant/ advisor for each Service and a member from each Service's medical Quality Assurance office. They discussed the Tri-Service regulation and technical publication. Their responses will be incorporated into both documents prior to being submitted for staffing.
The CLIAC agreed the CLIP office should continue its emphasis on education and dissemination of program information. They certified the process of working with labs to bring about successful adherence to CLIP requirements. Enforcement will continue to be a tool of last resort. Statistics on CY 95 proficiency testing (PT) were presented (tables on page 4). The CLIAC was pleased to see that most labs correct deficiencies after the first failure and never move to the unsuccessful category.
Accreditation Update
JCAHO recently published a new comprehensive manual of laboratory standards and scoring guidelines (1996 Comprehensive Accreditation Manual for Pathology and Clinical Laboratory Services) and a new accreditation manual (1996 Accreditation Manual for Pathology and Clinical Laboratory Services). These standards will take effect on 1 Jul 96. Approximately 10% of the standards are new. The new standards will be capped at a finding of no worse than 2 (on the 1-5 scale) for one year to give labs an opportunity to work towards compliance.
JCAHO will no longer integrate specific CAP findings into an organization's accreditation decision report effective 1 Jul 96. Under the new arrangement the following rules apply for CAP accredited labs:
1. The surveyed organization will provide JCAHO with the most recent copy of its CAP inspection report and accreditation award letter.
2. JCAHO will verify that it it has been no longer than 30 months since the CAP inspection.
3. The JCAHO accreditation decision report will state the lab was surveyed and accredited by CAP, not JCAHO.
4. The JCAHO lab accreditation grid will show a "C" in each element box, instead of a numerical score.
5. Organization performance reports that are publicly released will indicate that the lab is accredited by CAP.
6. An organization will not be eligible for Accreditation with Commendation until JCAHO receives the CAP report. The JCAHO accreditation decision is contingent upon receiving the CAP report.
7. If a laboratory without a current CAP accreditation is awaiting a scheduled CAP inspection, the organization's JCAHO accreditation report will not be mailed until con-firmation of the inspection date is received . In addition, the JCAHO report will indicate that the organization's JCAHO accreditation decision is contingent upon accreditation of the lab by CAP.
New CLIA Proposals
During the last few months, HCFA, CDC and HHS have published 3 proposed rules changes to CLIA. They are proposing to:
1. Expand the waived category (minimally complex in CLIP).
2. Establish a new subcategory of moderate complexity called accurate and precise technology (APT).
3. Change requirements for cytology PT.
The proposal to expand the waived category would automatically include any test cleared for home use by the FDA. Further, any test in this category would have to use direct unprocessed specimens, require no specimen manipulation prior to analysis and give direct readout of results. The system would have to include a fail-safe mechanism to prevent release of results outside the reportable range, or release of erroneous results due to test system malfunctions. There could be no invasive troubleshooting or maintenance and the operator instructions would have to be written to the seventh grader.
The APT category is proposed to accomodate high-quality test systems that could not qualify as a waived test under the proposed new waived categorization rules, but have less complex performance specifications than other moderate complexity tests. These systems would be allowed to contain steps that are limited in number and complexity. They would have to be self-contained, packaged as a complete system, and have an endpoint requiring, at most, a very simple interpretation. The main requirement for this category is that manufacturers instructions must be followed.
The proposal to revise PT requirements for cytology is the result of a court case challenging the original PT criteria. The original rules were overturned on grounds that personnel were not tested "to the extent practicable, under normal working conditions" as required by CLIA. The original rules allowed more time to examine PT slides than allowed by the maximum allowable work rate. The proposal shortens the time allowed for PT from 2 hr for a 10 slide exam to 45 min for the same exam.
HCFA Clarification
HCFA recently reversed its position on use of electronic simulator controls to meet QC requirements. They will not accept electronic simulator controls in lieu of chemical or external quality control to meet daily QC requirements. HCFA expressed their position that these controls "...provide only a pass or fail of the instrument, but not actual quantitative QC results; they do not monitor the entire testing process, particularly the analyte being tested." Obviously, manufacturers of point of care testing instruments are fighting this interpretation. However, HCFA's interpretation now stands. JCAHO and CAP have held differing positions on this issue in the past. JCAHO required initial validation of electronic controls against liquid controls. Once validated, JCAHO allowed use of 2 levels of electronic controls daily as long as the electronic controls were periodically validated against liquid controls. CAP does not allow electronic QC as the sole method of QC for instruments. Make sure your QC system complies with the requirements of your accrediting organization. This interpretation applies to the I-Stat and similar instruments. Point of care labs should consult with your local hospital Department of Pathology for assistance in setting up QC programs that meet this new HCFA interpretation. More information on this controversy will be published. We will keep you up to date on any changes.
Question Responses
During the past quarter the following question was most often asked:
Why can't nurses perform the fern test?
Nurses can perform the fern test under a certificate for moderate complexity. Most often this question arises because the nurse wants to be added to the provider performed microscopy (PPM) certificate for the clinic or ward. CLIP is very specific on who can perform tests under a PPM certificate. The only ones allowed to perform tests in this category are: physicians, nurse practitioners, nurse midwives and physician assistants. The PPM lab director cannot allow the nurse to perform this test under a PPM certificate even if the director wants to. If the lab director wants to allow nurses to perform this test they must apply for a new certificate for moderate complexity and meet all moderate complexity requirements. The new certificate must be issued prior to any nurse performing the procedure (with fax machines the process can be accomplished in a day or two). CLIP does not stop nurses from performing fern tests as long as all the requirements for moderate complexity are met. This includes documentation of training that encompases the requirements of para 493.1423. Testing under a moderate certificate requires an accreditation inspection every 2 years. Results must be reported in a retreivable fashion that identifies the testing location where the test was performed. The testing location needs to be registered correctly. The decision to register for moderate complexity to allow nurses to perform fern tests rests solely with the lab director as named on the CLIP certificate.
CAP Information
CAP accreditation requires enrollment in proficiency testing for all analytes tested by a lab unless no program is available for a given analyte. This differs from the requirement in CLIP to subscribe to PT for all registered analytes. One example of an overlooked survey is the neonatal bilirubin survey (NB). Labs tend to think bilirubin is covered in other surveys, however, neonatal bilirubin is a distinct test with its own PT survey. Please evaluate all surveys to ensure full participation and smooth sailing (term added for our Navy labs) to accreditation. The CY 96 CAP PT contracts are now in-place. Last year there were over 6,000 survey subscriptions. There are even more this year. Each service contract takes approximately 500 hr to prepare (thank you for providing SFC Miller, HMC Callahan and SMSgt Barnard with job security). Each service generates at least 3 contract modifications during the year. We ask your help in shortening the time needed for the initial award of these contracts. Please carefully review the Survey Renewal Form (received in Sep-Oct) and address known or anticipated changes to test menu and new instruments at this time. Your help in lowering the number of changes requested on the Survey Order Confirmation Sheet will help us get the contracts awarded without the typical "rush to confusion". These contracts will always need modification. All we ask is a little help by anticipating your needs earlier every fall.
OCLAB Sources
This bulletin is available on the AFIP home page at: http://www.afip.mil and on the Air Force Lab Bulletin Board at 1-800-257-USAF.
Our new phone numbers are published again because not everyone is aware of the changes. Please help in spreading the word.
1995 CLIP Statistics
Number of Certificates
Army |
Navy |
Air Force |
Total | |
| High/Mod | 321 |
201 |
167 |
689 |
| PPM | 83 |
78 |
114 |
275 |
| Minimal | 181 |
107 |
171 |
459 |
| Total | 585 |
386 |
452 |
1423 |
Number of Sites (# / Certificate)
| Army | Navy | Air Force | Total | |
| High | 158 | 128 | 149 | 435 |
| Moderate | 225(1.2) | 131(1.3) | 49(1.2) | 405 |
| PPM | 155(1.9) | 167(2.1) | 333(2.9) | 655 |
| Minimal | 523(2.9) | 283(2.6) | 644(3.8) | 1450 |
| Total | 1061 | 709 | 1175 | 2945 |
CAP Survey Results for 1995
| Army | Navy | Air Force | Total | |
| # Surveys | 2413 | 2035 | 1763 | 6211 |
| Fail 1X(%) | 208(8.6) | 276(13.6) | 238(13.5) | 722(11.6) |
| Fail 2X (%) | 50(2.1) | 41(2.0) | 38(2.2) | 129(2.1) |
| Fail 3X(%) | 3(0.1) | 0 | 2(0.1) | 5(0.1) |
OCLA Phone Numbers / Address
Army COL Martig 301-319-0133 SFC Miller 301-319-0073 |
Navy CDR Mann 301-319-0132 HMC Callahan 301=319-0074 |
Air Force Col Warnken 301-319-0134 CMSgt Barnard 301-319-0072 |
AFIP-ZD/OCLA, 1413 Research Blvd, Bldg 102, Rockville MD 20850-6000
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