The Centers for Medicare and Medicaid Services (CMS) have published a brochure with questions and answers regarding CLIA required proficiency testing: http://www.cms.gov/CLIA/downloads/CLIAbrochure8.pdf [1.10MB, PDF] Excerpts from that brochure with the more frequently asked questions are also presented below. Nonwaived providers are encouraged to review this CLIA brochure. Nonwaived providers include Provider Performed Microscopy (PPM) providers.
All initial non-waived applicants for state licensure must identify the name of the proficiency testing program in which the Laboratory participates for each specialty/subspecialty and the program set for each in the initial licensure application. This information must also be provided when adding a specialty/subspecialty. Additionally, Provider Performed Microscopy (PPM) laboratories must also indicate the quality assurance methodology used for each non-waived test.
Proficiency testing or PT is the testing of unknown samples sent to a Laboratory by a CMS approved PT program. Most sets of PT samples are sent to participating laboratories three times per year. After testing the PT samples in the same manner as its patient specimens, the Laboratory reports its sample results back to their PT program. The program grades the results using the CLIA grading criteria and sends the Laboratory scores reflecting how accurately it performed the testing. CMS and accreditation organizations routinely monitor their laboratories’ performance.
PT is required for only the limited number of tests found in Subpart I, Proficiency Testing Programs for Nonwaived Testing, of the CLIA regulations. If your Laboratory performs any of the tests found in subpart I, you must perform PT on each of the tests. We refer to the tests listed in subpart I as “regulated” analytes.
Review the specialty, subspecialty and analytes listed and determine which specialties, subspecialties and analytes you perform in your Laboratory. Enroll in a CMS approved PT program for each of those tests.
You must enroll in a CMS approved PT program. A detailed listing of these programs with their contact information and the tests for which they are approved is available at www.cms.hhs.gov/clia; click on “PT providers”.
PT enrollment and participation is required for each CLIA certificate; i.e., PT per certificate (excluding certificate of waiver). If you offer non-waived testing at more than one site, but the testing is all included under one certificate, you must enroll in an approved PT program(s) for all the “regulated” analytes covered under that certificate, not for each site. If you have a separate certificate for each site, you must enroll in PT for the tests performed at each site.
You may not randomly change from one approved PT program(s) to another. Laboratories must enroll and participate in one approved program for one year before designating a different program. Laboratories should enroll in the fall for the next calendar year. However, if you apply for a new CLIA certificate mid-year or add a “regulated” specialty, subspecialty, or analyte in the middle of a year, you may change PT programs at the next PT enrollment period.
Laboratories operating under a new certificate and/or adding new “regulated” testing must enroll in PT as soon as possible and complete the PT for the remainder of the year.
CLIA requires laboratories to take steps to assure the accuracy of testing in lieu of testing PT samples. CLIA requires that, at least twice annually, you verify the accuracy of any test or procedure that you perform that is not listed in Subpart I.
A few examples of ways to check the accuracy of testing not listed in Subpart I are as follows: Split a patient’s specimen (NEVER SPLIT A PT SAMPLE) with another Laboratory that offers the same test(s). Your director should review your results and the other Laboratory’s results for acceptability.
Yes, there are. There are times when the PT program cannot fully evaluate your samples and you must verify accuracy (a few ways to accomplish this are listed above). You must verify the accuracy of tests for which PT is required if any of the following occur:
NEVER discuss your PT results with another Laboratory and NEVER enter into discussion with another Laboratory about their PT results before the PT event cut-off date. This activity may cause you to lose your CLIA certificate.
NEVER send your PT samples to another Laboratory even if you send your patient specimens to another Laboratory for confirmation or identification testing. (Please read the PT results sheet carefully and select “Would refer” or “Test not performed” in these instances.) Sending PT samples to another Laboratory for testing is considered PT referral and will cause serious actions to be taken against your Laboratory, your Laboratory director, and the Laboratory owner. The penalties include loss of your Laboratory’s CLIA certificate for at least one year, your director cannot direct a Laboratory for two years, and your Laboratory owner may not own or operate a Laboratory for two years. Your Laboratory’s name will be listed on the CMS Laboratory Registry on the CMS web site. Be extremely cautious NOT to send PT samples out for a “reflex” test. (A “reflex” test is a test procedure routinely added-on to a patient specimen when the test results are at a level that meets the clinician’s threshold to automatically add specific tests. This is usually done by a “standing” order.)
As soon as you identify them as PT samples, notify your inspecting agency (your accreditation organization if your Laboratory is accredited or your State agency inspectors) that you have received PT samples from another Laboratory, tell them the name of the other Laboratory and the test(s) requested, but DO NOT TEST the samples.
Yes, you must keep a copy of all your records, such as the step by step PT sample preparation and handling, all the steps taken in the testing of the sample, a copy of the PT program results form used to record and submit your PT results (includes the attestation statement), a print screen if results are entered electronically, and the PT program’s evaluation of your Laboratory’s performance, etc. These copies must be maintained for a minimum of two years from the date of the PT event. If any corrective actions are taken as a result of an unsatisfactory or unacceptable score, maintain records of these actions for two years also.
This CLIA brochure (http://www.cms.gov/CLIA/downloads/CLIA%20brochure8.pdf) [1.10MB, PDF] lists the regulated analytes beginning on page 10. Hospitals and independent laboratories are required to enroll in Proficiency Testing for all tests performed, if PT is available for the test. If PT is not available for a test, they must have a method to verify accuracy twice annually.
Laboratories operated by practitioners exclusively for diagnosis and treatment of their own patients are required to enroll only in the regulated analytes and they must perform twice annual verification of accuracy for non-regulated analytes.
Aerobic/Anaerobic Culture & Identification Antibiotic Susceptibility Testing Direct Bacterial Antigen Detection Gram Stain
Acid Fast Stain Mycobacteriology Identification Mycobacteriology Susceptibility Testing
Culture and Identification
Presence or Absence of Parasites
Identification of Parasites
Direct Viral Antigen Detection
Viral Isolation and Identification
Syphilis Serology General Immunology
Alpha-1 Antitrypsin Alpha Fetoprotein (tumor marker) Antinuclear Antibody Antistreptolysin O Anti-Human Immunodeficiency Virus
Hepatitis B Surface Antigen (HBsAg)
Hepatitis B Core Antibody
Hepatitis Be Antigen (HBeAg)
Infectious Mononucleosis Rheumatoid Factor Rubella
(ALT or SGPT)
Amylase Aspartate Aminotransferase (AST or SGOT)
Creatine Kinase, total
Creatine Kinase, Isoenzyme (CK-MB) Creatinine Glucose Iron, total Lactate Dehydrogenase (LDH), total LDH Isoenzymes (LDH1/LDH2) Magnesium Potassium Sodium Total Protein Triglycerides Urea Nitrogen Uric Acid
Cortisol Free Thyroxine Human Chorionic Gonadotropin T3 Uptake Triiodothyronine Thyroid Stimulating Hormone Thyroxine, total
Gentamicin Lithium Phenobarbital Phenytoin Primidone Procainamide and Metabolite Quinidine Theophylline Tobramycin Valproic acid
Cell Identification WBC Differential Erythrocyte Count Hematocrit Hemoglobin Leukocyte Count Platelet Count Fibrinogen Partial Thromboplastin Time Prothrombin Time
ABO Group D (Rho) Typing Unexpected Antibody Detection Compatibility Testing Antibody Identification