Professional Documents
Culture Documents
CLIAbrochure8 PDF
CLIAbrochure8 PDF
Improvement Amendments
(CLIA)
Brochure # 8
PROFICIENCY
TESTING
LABORATORIES PERFORMING
NON-WAIVED TESTS
Why is PT important?
PT is important because it is a tool the laboratory can use to verify the accuracy
and reliability of its testing. Routine reviews of PT reports by the laboratory staff
and director will alert them to areas of testing that are not performing as expected
and also indicate subtle shifts and trends that, over time, would affect their patient
results.
2
Is PT required for all nonwaived testing?
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.
A listing of these tests may be found on the last page of this brochure.
3
If I have more than one testing site, do I need to enroll in
PT for each site?
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.
4
Perform PT on the tests (many PT programs offer a limited number of PT
samples for “unregulated” tests), but NEVER send the PT samples out of
the laboratory for any reason. Depend on the scoring by the PT program to
determine accuracy.
When your results are submitted to the program after the deadline and are
considered a late submission, your laboratory grade will be zero.
If you did not test your PT samples at all, your laboratory grade will be zero.
There are instances when your grade does not reflect your performance
because there was no consensus among all laboratories performing the PT
sample(s). You will see this identified by the PT program as “ungradable” on
your results report. You will be assigned an artificial score of “100%”, noted as
“ungradable”, but that does NOT reflect your performance.
5
May I discuss my PT results with another laboratory?
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.
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.)
7
What does unsatisfactory PT performance mean?
Unsatisfactory PT performance means failure to attain the minimum satisfactory
score for an analyte, test, subspecialty, or specialty for a testing event.
8
If you have been required to cease testing, your Medicare and Medicaid
reimbursement will be suspended for a six month period. However, you may
purchase your re-instatement PT events at any time after you have identified and
corrected the problem(s) that caused the unsuccessful performance. You should
purchase these samples from your PT program, but you may obtain them from
any CMS approved PT program.
You may decide to voluntarily stop testing the unsuccessful analyte, subspecialty,
or specialty. As soon as you receive your PT results indicating an unsuccessful
performance, you must notify your regional office CLIA consultant that testing of
the unsuccessful analyte, subspecialty, or specialty has been stopped voluntarily.
This notification must be made before you receive a letter from your CMS regional
office imposing a cease testing sanction. You will need to successfully perform
two consecutive PT events for the analyte, subspecialty, or specialty that was
unsuccessful. Your Medicare and Medicaid reimbursement will not be affected.
Be sure to read the CLIA regulations for proficiency testing (available on the
CMS web site). This brochure is not intended to replace or be a substitute for
the CLIA regulatory requirements. It is intended only to present most of the
proficiency testing requirements in layman’s terms.
9
List of Nonwaived Testing for which PT is Required:
MICROBIOLOGY Complement C4
Identification (Anti-HBc)
IgG
Mycobacteriology IgM
Identification of Parasites
(ALT or SGPT)
Virology Albumin
Alpha-1 Antitrypsin pH
pCO2
Antinuclear Antibody
Calcium, total
Antistreptolysin O
Chloride
(Anti-HIV)
Cholesterol, HDL
Complement C3
10
Creatine Kinase, total Gentamicin
Creatine Kinase, Isoenzyme Lithium
(CK-MB) Phenobarbital
Creatinine Phenytoin
Glucose Primidone
Iron, total Procainamide and Metabolite
Lactate Dehydrogenase (LDH), total Quinidine
LDH Isoenzymes (LDH1/LDH2) Theophylline
Magnesium Tobramycin
Potassium Valproic acid
Sodium
HEMATOLOGY
Total Protein
Cell Identification
Triglycerides
WBC Differential
Urea Nitrogen
Erythrocyte Count
Uric Acid
Hematocrit
Endocrinology
Hemoglobin
Cortisol
Leukocyte Count
Free Thyroxine
Platelet Count
Human Chorionic Gonadotropin
Fibrinogen
T3 Uptake
Partial Thromboplastin Time
Triiodothyronine
Prothrombin Time
Thyroid Stimulating Hormone
Thyroxine, total IMMUNOHEMATOLOGY
Toxicology ABO Group
Blood Alcohol
D (Rho) Typing
Blood Lead
Unexpected Antibody Detection
Carbamazepine
Compatibility Testing
Digoxin
Antibody Identification
Ethosuximide
11
Where can I find additional information and
guidance?
Assistance for meeting the requirements is provided in Appen
dix C of the State Operatons Manual (CMS Publication 7),
which is posted on CMS’s CLIA website.
www.cms.hhs.gov/clia
September 2008