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.

With the ongoing emphasis on point-of-care testing and recent additions to the waived testing category, many manufacturers are rapidly developing new "bedside" procedures and instruments. Some of these manufacturers claim their systems are "CLIA waived" when in fact they are not. Bottom Line - if the test does not appear in the Federal Register as a waived test, it is not approved under that test category. If the manufacturer says they have recent approval, ask to see the letter from Health and Human Services/Centers for Disease Control categorizing the test as waived. Ask for this letter before you purchase kits, reagents or test systems. New test systems not listed under any category in the Federal Register are considered high complexity pending categorization by HHS and CDC. The CDC maintains a ftp web site with a file of all catagorized procedures/kits. ftp://ftp.cdc.gov/pub/laboratory_info/CLIA/

Many laboratories continue to discover previously unknown sites performing point-of-care testing (POCT). The key to a good POCT program is facility-wide involvement, which includes hospital or clinic regulations addressing authorized sites and testing requirements.

The latest edition of the DOD CLIP manual has just been published. Because of the limited number of copies, we were only able to send the manuals to Departments of Pathology, Laboratory Services, QA Offices (Army and Navy), and Command Consultants (Air Force). Laboratories or Departments of Pathology should coordinate the use of this manual with ancillary labs and point-of-care testing sites.

The 1997 contract for CAP proficiency surveys was finalized. If you failed to submit your renewal form, you will need to use local funds for your surveys pending modifications to the contracts in the June/July timeframe. Laboratories included in the contracts will receive an "Order Confirmation" from CAP in Jan 97. Please carefully review the confirmation sheet, indicate any additions or deletions, and fax it back to our office ASAP. This will be your final chance to correct your survey order until the modifications scheduled for this summer.

Not sure of the difference between a site and location when filling out an Application for Survey with the Joint Commission on Accreditation of Healthcare Organizations (JCAHO)? Their most recent Laboratory Focus newsbrief has this distinction -- sites are separate, geographically distinct facilities. The main site is where the surveyor arrives on the first day. Locations are areas where testing takes place. Therefore, there may be multiple locations within one site, e.g., main laboratory, stat laboratory, nuclear medicine laboratory, etc, with one or more CLIP numbers.

Here is a link to the Navy Blood Program web site: http://support1.med.navy.mil/bumed/med-02/med-27/nbp.htm

Labs scheduled to be inspected by JCAHO in 1998 will also be inspected for their compliance with Occupational Safety and Health Administration (OSHA) safety regulations under the terms of a three-year partnership recently established between JCAHO and OSHA. The program will be described in the 1997 JCAHO hospital standards manual. If your hospital is JCAHO accredited now, you have probably been made very aware of the safety requirements of JCAHO.

This bulletin and the previous one are available on the AFIP home page at: http://www.afip.mil

Follow the link through OCLAB to the bulletins.

Our office has moved within the D.C. area. We are now located in Rockville, MD. The address is:

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

Please see the box below for our new phone and fax numbers.

As those of you in high complexity labs are aware, the lab must have a qualified technical supervisor for each of the specialties or subspecialties for which the lab is registered. One of the responsibilities of the technical supervisor is the evaluation of the competency of all testing personnel. Documentation of this competency assessment is required by all of our accrediting agencies (AABB, CAP, and JCAHO), with the minimum procedures to be used detailed in the CLIP regulations. They are --

• Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing.
• Monitoring the recording and reporting of test results.
• Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records.
• Direct observation of performance of instrument maintenance and function checks.
• Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples.
• Assessment of problem solving skills.

Q. Do I need to notify your office every time we change analyzers or test methodologies?

A. You only need to notify us if your lab is not accredited by CAP or if the change in methodologies changes the complexity of procedures performed in your lab.