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.
Updating CLIP Registration
Laboratories must notify our office within 30 days if there are changes in facility name, location, or directorship (section 493.51 of CLIP Manual). Additionally, if your laboratory is College American Pathologists (CAP) accredited, you must notify the CAP Accreditation Department. CAP, unlike the CLIP office, also requires a Curriculum Vitae for all newly designated laboratory directors.
Downsizing Your Lab?
As laboratories are downsizing, questions have risen about the appropriateness of downgrading CLIP registrations from high to moderate complexity. When determining a laboratory's complexity, keep in mind that complexity is not based on the size of the facility. Complexity is determined by the analytes being tested and the methodology being used. If a laboratory tests for even one analyte classified as highly complex, then the laboratory must remain registered as highly complex. If the downsized laboratory does indeed meet criteria for moderate complexity, proficiency testing and accreditation are still required for compliance with CLIP standards. For the latest information on the complexity of tests, see the following website. ftp://ftp.cdc.gov/pub/laboratory_info/CLIA/
Point Of Care Questions/Answers
It appears there is still a great deal of confusion concerning point-of-care testing and requirements under DoD CLIP. Below are discussions on some of the more common questions we have received. POCT sites do not have to be under the directorship of the laboratory. Under the Minimally Complex (Waived) category, there are no specific personnel requirements. The director, however, should be someone qualified to assess the quality of testing and competency of testing personnel. Under the PPM category, the director must be a physician, midlevel practioner, or a dentist. Sites performing tests other than those specifically listed under the PPM and minimally complex categories must be directed by someone who is qualified as director for a moderate or high complexity laboratory. Also, moderate and high complexity sites need to meet other applicable personnel and testing requirements specified in the DoD CLIP manual. This would include appointment of a qualified Technical supervisor and enrollment in PT, if available. POCT sites have to be under the directorship of the laboratory to qualify for CAP accreditation. CAP will only inspect POCT sites whose director is the same as the main laboratory's. Sites not under lab directorship can and should be included in the facility's JCAHO inspection and accreditation process. NOTE: CAP will recognize different directors for Cardiopulmonary and Nuclear Medicine labs because they are considered Special Function laboratories, not POCT sites. IAW Sections 4-2 and Chapter 5 of the DoD CLIP manual, sites performing moderate or high complexity tests should be inspected by a private non-profit accreditation program prior to the expiration of their original registration certificates. As far as minimally complex and PPM sites are concerned, there is no specific requirement under CLIP (or CLIA) for them to be accredited. However, inspection of all known POCT sites remains a requirement for JCAHO accreditation of a clinic or hospital. CAP accredited sites, POCT or otherwise, are not inspected by JCAHO but their inspection results are incorporated into the rating for the entire facility. CLIP does not require PPM and minimally complex sites to be enrolled in proficiency testing. However, if your POCT sites are CAP accredited, they should either enroll in the PT program or validate their methods at least semi-annually against those in the main lab. NOTE: PT failures in the main lab affect all internally validated methods.
Reference Lab Reports
Do you send specimens to reference laboratories that send you results electronically? Do you have other reference labs that send you paper reports? Have you had difficulty with CAP General Checklist question #01:4143 regarding retention of reference laboratory reports? The official word from the CAP LAP regarding the intent of that checklist question is that a referring laboratory must have a copy of the original report or have access to it if needed. The commentary for question 01.4385 states that stored patient result data and archival information must be easily and readily retrievable within a time frame (less that 4 hours) consistent with patient care needs. If you have documentation from the reference laboratory that they retain their records for a minimum of two years and can retrieve them within four hours, and you retain paper copies for the other reference labs for two years, then you meet the intent of the question.
CAP Inspection Highlights
Regarding CAP inspections, here are some Phase II questions that laboratories have been cited for in the past year. #01.2000 Accrediting agencies require that a quality improvement plan be in place that effectively monitors the contribution to patient care provided by the laboratory service and that the plan be fully integrated with the Health Care facility's overall plan. 01.2040 Must be evidence of review of the effectiveness of the laboratory's Quality improvement plan as it is integrated with the overall institutional plan. There must be evidence of corrective action when problems are identified.
Clip Certificates
A comprehensive review of all registration and accreditation records was recently completed and the following certificates are being distributed to all eligible labs and testing sites: Certificates of Accreditation, Compliance, Provider Performed Microscopy and Minimal Complexity. If your lab or testing site has met CLIP requirements, you will soon receive the appropriate certificates along with letters specifying the sites certified for testing. Please review the letters and certificates for accuracy. If you have any changes, fax or email them to us ASAP. As you review the letters and certificates, please note the dates on the Certificate of Accreditation are based upon the date of your last accreditation inspection. They remain valid for two years from the date of accreditation, not the date the certificate was issued. On the other hand, you will note the date on the Certificates of PPM and Minimal Complexity reflect the date they were processed and printed since there is no specific CLIP requirement for accreditation of these sites.
CAP Checklist Changes
The 1997 edition of CAP's Laboratory General Checklist, Section 1, lists 5 new items regarding the duties and responsibilities of consulting pathologists. These items specify that the duties and responsibilities include documented involvement in laboratory quality control and quality assurance programs along with consultation with the medical staff. Additionally, CAP now specifies that consulting pathologists should visit the laboratory at least monthly and provide written reports to the on-site laboratory director and hospital commander.
OCLAB Sources
This bulletin and previous ones can be reached through the AFIP home page at: http://www.afip.mil
Whole Blood Glucose Surveys
CAP recently advised us that many labs using the BMC Advantage and Advantage H instruments continue to use the wrong instrument codes despite cautionary letters from the manufacturer and CAP Survey Department. According to Kim Davis of the Survey Evaluation Department, CAP will be screening all data from Advantage and Advantage H users. If a lab's results appear to be inconsistant with the data reported by others using that same instrument code, the results will not be evaluated or included in the survey summary. Additionally, CAP will send the lab a letter advising them to review the instrument codes for the WBG Survey and ensure use of the proper code in the future. If you have questions concerning the WBG or WB2 surveys and instrument codes, contact Kim Davis, CAP Survey Evaluation Department, Tel (847) 832-7344 or FAX (847) 832-8166.
Clerical Errors on PT Surveys
When filling out the answer sheets for proficiency testing surveys, pay attention to what you are writing and double check it. There have been a significant number of PT failures lately due to clerical errors, such as misplaced decimal points. If technicians are making these mistakes on PT answer sheets, what are they doing with patient reports? Written responses to these errors should address that issue also.
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 Barnard 301-319-0072 |
AFIP-ZD/OCLA, 1413 Research Blvd, Bldg 102, Rockville MD 20850-6000
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