Clinical Laboratory

Improvement Amendments
(CLIA)
Brochure # 8

PROFICIENCY
TESTING

DOs and DON’Ts

NOTE: Congress passed the Clinical Laboratory Improvement Amendments

(CLIA) in 1988 establishing quality standards for all laboratory testing to ensure
the accuracy, reliability and timeliness of patient test results regardless of where
the test was performed. The final CLIA regulations were published in the Federal
Register on February 28, 1992. The requirements are based on the complexity of
the test and not the type of laboratory where the testing is performed. On January
24, 2003, the Centers for Disease Control and Prevention (CDC) and the
Centers for Medicare & Medicaid Services (CMS) published final CLIA Quality
Systems laboratory regulations that became effective April, 24, 2003.
 IMPORTANT INFORMATION FOR

LABORATORIES PERFORMING

NON-WAIVED TESTS

Frequently Asked Questions about CLIA Requirements for

Proficiency Testing (PT)
NOTE: This brochure information applies to CMS inspected laboratories. If your
laboratory is accredited, you MUST follow the proficiency testing requirements of
your accreditation organization. This does not apply to cytology PT.

What is proficiency testing?

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.

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.

If I only perform waived testing, am

I required to perform PT?
PT is not required for any test that is waived. (Check
the FDA web site to determine whether your test(s)
are waived: www.FDA.gov/cdrh/CLIA) However,
enrolling in a PT program and performing PT
on your waived test(s) will provide you with an
excellent indication of the accuracy of the waived
test(s) and thus improve the quality of testing
you provide to your patients. It also serves to
demonstrate the accuracy of your testing if it is ever
questioned.

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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.

Can I enroll in any program that offers PT?

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”.

What must I do to enroll in PT?

Using the list on the CLIA web site, choose one (more than one, if your director
wishes) of the approved PT program(s) that offer(s) the tests you perform in your
laboratory. The PT program will assist you with your enrollment if you ask. The
program will notify CMS of your enrollment and the PT testing you have signed up
to perform.

How do I enroll for bacteriology? Must I enroll for five

PT samples for each test I do in bacteriology; Gram
stain, direct antigen, identification of organisms, and/or
susceptibility testing?
Your laboratory must enroll for a total of five PT samples per testing event and
those five samples must include at least one of the types of testing your laboratory
performs – Gram stains, direct antigen, identification of organisms, and/or
susceptibility testing. If you perform one or two of these procedures, the five samples
must include the one or two tests you perform. Call your PT program; the PT
representatives will help you enroll properly. Assisting you with proper enrollment is
a CLIA requirement for approved PT programs.

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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.

May I change my PT program whenever I wish as long as it

is CMS approved?
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.

If my laboratory is new or if I add a new “regulated”

specialty, subspecialty or analyte in the middle of a
calendar year, how quickly must I enroll in PT?
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.

If I perform “unregulated” testing (tests for which PT is

not required), am I required to check the accuracy and
reliability of those tests?
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.

How do I verify the accuracy of the tests that do not have

PT required?
A few examples of ways to check the accuracy of testing not listed in Subpart I are as
follows:
ƒ 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.

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 ƒ 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.

Are there ever circumstances in PT that require my

laboratory to verify the accuracy of “regulated” tests?
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:

ƒ When your results are submitted to the program after the deadline and are
considered a late submission, your laboratory grade will be zero.
ƒ If you did not test your PT samples at all, your laboratory grade will be zero.
ƒ 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.

Do I test my PT samples any differently than I test patient

specimens?
PT samples must be tested in the same manner you test patient specimens. This
means testing the PT samples the same number of times as patient specimens, at the
same time as patient specimens, by the same personnel that routinely test the patient
specimens, and using the same test system that is routinely used for the patient
specimens. PT samples should be rotated among the testing personnel in your
laboratory.
Please note that some PT sample preparation
may be necessary before testing. In other words,
after preparation, PT samples must be treated in
the same manner as patient specimens. However,
as stated below, NEVER send PT samples out
of your laboratory for any reason, even if you
routinely send out patient specimens for additional
or confirmatory testing.

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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.

May I send my PT samples to another laboratory to see if

they get the same results as I do?
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.)

What do I do if I receive PT samples from another

laboratory for testing?
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.

Do I need to keep records of my PT testing?

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.
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If I perform the same test using two different test systems,
must I perform PT on both test systems?
PT is required for only the test system, assay, or examination used as the primary
method for patient testing during the PT event.

How long do I have to test and report the PT samples?

The instructions that accompany the PT samples will state the exact date by which
you must return your PT results to the program. It is very important to return them
on time. A late submission will result in a score of zero for the testing event.

What steps should I take after I have received my PT

results from the PT program?
Always review your results with your co-workers and your director. Your PT
program will include an evaluation for each of the five challenges for each test or
analyte in the PT event and will detail the performance of each test system used by
the laboratories enrolled with their program.
This should be done for all PT results, even those with passing scores. If you receive
an 80% score, you should investigate why one of the five samples was outside the
acceptable range of results. Document your investigation and what you did to
correct the problem that caused the challenge failure.

What must I do if I do not get a passing score when the PT

program grades my results?
Re-review the results that were submitted to the PT program for scoring for any
obvious errors (this should have been done prior to submitting your results to
the program). Clerical or transcription errors are considered incorrect results. The
director of your laboratory as well as the personnel who performed the testing of the
PT samples should compare their PT results with the inter-laboratory comparison
evaluations provided by the PT program. You must take remedial actions, i.e.,
determine the cause of the error or errors, correct it (them), and document your
actions. Continually monitor the test system performance, review the results of the
quality control materials, and discuss with your director to be certain the test system
is operating properly and producing accurate results. Your director may want to
review the results of the patients tested during the unsatisfactory or unacceptable
testing event. Depending upon the test system’s performance and your director’s
decision, you may need to contact the manufacturer of the test system for assistance.

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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.

What does unsuccessful participation* in PT mean?

Unsuccessful participation in PT means any of the following:
ƒ Unsatisfactory performance for the same analyte in two consecutive or two
out of three testing events.
ƒ Repeated unsatisfactory overall testing event scores for two consecutive or
two out of three testing events for the same specialty or subspecialty.
ƒ An unsatisfactory testing event score for those subspecialties not graded
by analyte (that is, bacteriology, mycobacteriology, virology, parasitology,
mycology, compatibility testing, unexpected antibody detection, antibody
identification) for the same subspecialty for two consecutive or two out of
three testing events.

What does unsuccessful PT performance* mean?

Unsuccessful PT performance means a failure to attain a satisfactory score for an
analyte, subspecialty, or specialty for two consecutive or two of three consecutive
testing events.
*Please note—unsuccessful performance and unsuccessful participation are
interchangeable. CMS inspectors generally will use unsuccessful performance.

If I do not successfully participate in PT, what happens?

If your laboratory has never had an unsuccessful performance for any PT analyte,
subspecialty, or specialty, the CLIA regulations, under certain circumstances, permit
technical assistance and training to take place, rather than a more serious sanction.
However, repeated unsuccessful PT performance for that same analyte, subspecialty
or specialty may result in your laboratory no longer being allowed to perform the
failed testing.

My laboratory has been required to cease testing an

unsuccessful analyte, subspecialty, or specialty. What must
I do to be able to resume testing?
First, you must demonstrate that your laboratory has identified the reason(s) for
your unsuccessful performance and corrected it (them). Be sure to document
this process. Secondly, when you are certain you have corrected the problem(s),
your laboratory must perform two consecutive PT events (re-instatement PT)
successfully, which will demonstrate correction of the problem(s).

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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.

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 List of Nonwaived Testing for which PT is Required:

MICROBIOLOGY Complement C4

Bacteriology Hepatitis B Surface Antigen (HBsAg)

Aerobic/Anaerobic Culture & Hepatitis B Core Antibody

Identification (Anti-HBc)

Antibiotic Susceptibility Testing Hepatitis Be Antigen (HBeAg)

Direct Bacterial Antigen Detection Immunoglobulins, total:

Gram Stain IgA

IgG

Mycobacteriology IgM

Acid Fast Stain IgE

Mycobacteriology Identification Infectious Mononucleosis

Mycobacteriology Susceptibility Testing Rheumatoid Factor
Mycology Rubella
Culture and Identification CHEMISTRY
Parasitology Routine Chemistry
Presence or Absence of Parasites
Alanine Aminotransferase

Identification of Parasites
(ALT or SGPT)

Virology Albumin

Direct Viral Antigen Detection

Alkaline Phosphatase

Viral Isolation and Identification

Amylase
Aspartate Aminotransferase (AST or
DIAGNOSTIC IMMUNOLOGY SGOT)
Syphilis Serology Bilirubin, total

General Immunology Blood Gases:

Alpha-1 Antitrypsin pH

pCO2

Alpha Fetoprotein (tumor marker)

pO2

Antinuclear Antibody
Calcium, total

Antistreptolysin O
Chloride

Anti-Human Immunodeficiency Virus

Cholesterol, total

(Anti-HIV)

Cholesterol, HDL

Complement C3

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 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

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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