Changes to form

DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES

Form Approved

OMB No. 0938-0581

CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA)

APPLICATION FOR CERTIFICATION

I. GENERAL INFORMATION

Initial Application

Survey

Change in Certificate Type

CLIA IDENTIFICATION NUMBER
_______________D________________________

Closure/Other Changes (Specify)

(If an initial application leave blank, a number will be assigned)

Effective Date

FACILITY NAME

FEDERAL TAX IDENTIFICATION NUMBER

EMAIL ADDRESS

TELEPHONE NO. (Include area code)

FACILITY ADDRESS — Physical Location of Laboratory (Building, Floor, Suite
if applicable.) Fee Coupon/Certificate will be mailed to this Address unless
mailing or corporate address is specified

MAILING/BILLING ADDRESS (If different from facility address) send Fee

NUMBER, STREET (No P.O. Boxes)

NUMBER, STREET

CITY

STATE

ZIP CODE

FAX NO. (Include area code)

Coupon or certificate

CITY

STATE

ZIP CODE

SEND CERTIFICATE TO THIS ADDRESS SEND FEE COUPON TO THIS ADDRESS CORPORATE ADDRESS (If different from facility) send Fee Coupon or

Physical

Physical

Mailing

Mailing

Corporate

Corporate

certificate

NUMBER, STREET

NAME OF DIRECTOR (Last, First, Middle Initial)

CITY

STATE

ZIP CODE

CREDENTIALS

FOR OFFICE USE ONLY
Date Received ____________________________________________________

II. TYPE OF CERTIFICATE REQUESTED ((Check only one) Please refer to the accompanying instructions for inspection and

certificate testing requirements)

Certificate of Waiver (Complete Sections I – VI and IX – X)
Certificate for Provider Performed Microscopy Procedures (PPM) (Complete Sections I – X)
Certificate of Compliance (Complete Sections I – X)
Certificate of Accreditation (Complete Sections I – X) and indicate which of the following organization(s) your
laboratory is accredited by for CLIA purposes, or for which you have applied for accreditation for CLIA purposes.
The Joint Commission
CAP

AOA
COLA

AABB

ASHI

If you are applying for a Certificate of Accreditation, you must provide evidence of accreditation for your
laboratory by an approved accreditation organization as listed above for CLIA purposes or evidence of application
for such accreditation within 11 months after receipt of your Certificate of Registration.
NOTE: Laboratory directors performing non-waived testing (including PPM) must meet specific education,
training and experience under subpart M of the CLIA regulations. Proof of these qualifications for the laboratory
director must be submitted with this application.

Form CMS-116 (01/14)

1

III. TYPE OF LABORATORY (Check the one most descriptive of facility type)
01 Ambulance
02 Ambulatory Surgery Center
03 Ancillary Testing Site in
Health Care Facility

04 Assisted Living Facility
05 Blood Bank
06 Community Clinic
07 Comp. Outpatient Rehab Facility
08 End Stage Renal Disease
Dialysis Facility
09 Federally Qualified
Health Center
10 Health Fair
11 Health Main. Organization
12 Home Health Agency

IV. HOURS OF LABORATORY TESTING
SUNDAY

13
14
15
16
17
18

Hospice
Hospital
Independent
Industrial
Insurance
Intermediate Care Facilities for
Individuals with Intellectual
Disabilities
19 Mobile Laboratory
20 Pharmacy
21 Physician Office
Is this a shared lab?
Yes
No

22 Practitioner Other (Specify)
______________________________
23 Prison

24 Public Health Laboratories
25 Rural Health Clinic
26 School/Student Health Service
27 Skilled Nursing Facility/
Nursing Facility
28 Tissue Bank/Repositories
29 Other (Specify)
______________________________

(List times during which laboratory testing is performed in HH:MM format) If

MONDAY

TUESDAY

WEDNESDAY

THURSDAY

testing 24/7 Check Here

FRIDAY

SATURDAY

FROM:
TO:
(For multiple sites, attach the additional information using the same format.)

V. MULTIPLE SITES (must meet one of the regulatory exceptions to apply for this provision in 1-3 below)
Are you applying for a single site CLIA certificate to cover multiple testing locations?
No. If no, go to section VI.

Yes. If yes, complete remainder of this section.

Indicate which of the following regulatory exceptions applies to your facility’s operation.
1.

Is this a laboratory that is not at a fixed location, that is, a laboratory that moves from testing site to testing site, such as
mobile unit providing laboratory testing, health screening fairs, or other temporary testing locations, and may be covered
under the certificate of the designated primary site or home base, using its address?
Yes

No

If yes and a mobile unit is providing the laboratory testing, record the vehicle identification number(s) (VINs) and attach to
the application.
2.

Is this a not-for-profit or Federal, State or local government laboratory engaged in limited (not more than a combination
of 15 moderate complexity or waived tests per certificate) public health testing and filing for a single certificate for
multiple sites?
Yes

No

If yes, provide the number of sites under the certificate____________ and list name, address and test performed for each
site below.
3.

Is this a hospital with several laboratories located at contiguous buildings on the same campus within the same physical
location or street address and under common direction that is filing for a single certificate for these locations?
Yes

No

If yes, provide the number of sites under this certificate____________ and list name or department, location within
hospital and specialty/subspecialty areas performed at each site below.
If additional space is needed, check here

and attach the additional information using the same format.

NAME AND ADDRESS/LOCATION

TESTS PERFORMED/SPECIALTY/SUBSPECIALTY

NAME OF LABORATORY OR HOSPITAL DEPARTMENT
ADDRESS/LOCATION (Number, Street, Location if applicable)
CITY, STATE, ZIP CODE

TELEPHONE NO. (Include area code)

NAME OF LABORATORY OR HOSPITAL DEPARTMENT
ADDRESS/LOCATION (Number, Street, Location if applicable)
CITY, STATE, ZIP CODE
Form CMS-116 (01/14)

TELEPHONE NO. (Include area code)
2

In the next three sections, indicate testing performed and annual test volume.

VI. WAIVED TESTING
Identify the waived testing (to be) performed. Be as specific as possible. This includes each analyte test system or device used
in the laboratory.
e.g. (Rapid Strep, Acme Home Glucose Meter)

Indicate the ESTIMATED TOTAL ANNUAL TEST volume for all waived tests performed ________________
Check if no waived tests are performed

VII. PPM TESTING
Identify the PPM testing (to be) performed. Be as specific as possible.
e.g. (Potassium Hydroxide (KOH) Preps, Urine Sediment Examinations)

Indicate the ESTIMATED TOTAL ANNUAL TEST volume for all PPM tests performed ________________

For laboratories applying for certificate of compliance or certificate of accreditation, also include PPM test volume in the

specialty/subspecialty category and the “total estimated annual test volume” in section VIII.

Check if no PPM tests are performed
If additional space is needed, check here

and attach additional information using the same format.

VIII. NON-WAIVED TESTING (Including PPM testing if applying for a Certificate of Compliance or Accreditation)
If you perform testing other than or in addition to waived tests, complete the information below. If applying for one
certificate for multiple sites, the total volume should include testing for ALL sites.
Place a check (3) in the box preceding each specialty/subspecialty in which the laboratory performs testing. Enter the
estimated annual test volume for each specialty. Do not include testing not subject to CLIA, waived tests, or tests run for quality
control, calculations, quality assurance or proficiency testing when calculating test volume. (For additional guidance on counting
test volume, see the instructions included with the application package.)
If applying for a Certificate of Accreditation, indicate the name of the Accreditation Organization beside the applicable specialty/
subspecialty for which you are accredited for CLIA compliance. (The Joint Commission, AOA, AABB, CAP, COLA or ASHI)
SPECIALTY /
SUBSPECIALTY
HISTOCOMPATIBILITY 010
Transplant
Nontransplant
MICROBIOLOGY

ACCREDITING
ANNUAL
ORGANIZATION TEST VOLUME

SPECIALTY /
SUBSPECIALTY

Hematology
IMMUNOHEMATOLOGY
ABO Group & Rh Group 510
Antibody Detection (transfusion) 520

Mycobacteriology 115

Antibody Detection (nontransfusion) 530

Mycology 120

Antibody Identification 540

Parasitology 130

Compatibility Testing 550
PATHOLOGY

DIAGNOSTIC IMMUNOLOGY

Histopathology 610

Syphilis Serology 210

Oral Pathology 620

General Immunology 220

Cytology 630

CHEMISTRY
Routine 310
Urinalysis 320
Endocrinology 330
Toxicology 340
Form CMS-116 (01/14)

ANNUAL
TEST
VOLUME

HEMATOLOGY 400

Bacteriology 110

Virology 140

ACCREDITING
ORGANIZATION

RADIOBIOASSAY 800
Radiobioassay
CLINICAL CYTOGENETICS 900
Clinical Cytogenetics

TOTAL ESTIMATED ANNUAL TEST VOLUME:
3

IX. TYPE OF CONTROL (check the one most descriptive of ownership type)
VOLUNTARY NONPROFIT

01 Religious Affiliation

FOR PROFIT

GOVERNMENT

04 Proprietary

05 City

02 Private Nonprofit

06 County

03 Other Nonprofit

07 State
08 Federal

(Specify)

09 Other Government
(Specify)

X. DIRECTOR AFFILIATION WITH OTHER LABORATORIES

If the director of this laboratory serves as director for additional laboratories that are separately certified, please
complete the following:
CLIA NUMBER

NAME OF LABORATORY

ATTENTION: READ THE FOLLOWING CAREFULLY BEFORE SIGNING APPLICATION
Any person who intentionally violates any requirement of section 353 of the Public Health Service Act as
amended or any regulation promulgated thereunder shall be imprisoned for not more than 1 year or fined
under title 18, United States Code or both, except that if the conviction is for a second or subsequent violation
of such a requirement such person shall be imprisoned for not more than 3 years or fined in accordance with
title 18, United States Code or both.
Consent: The applicant hereby agrees that such laboratory identified herein will be operated in accordance with
applicable standards found necessary by the Secretary of Health and Human Services to carry out the purposes
of section 353 of the Public Health Service Act as amended. The applicant further agrees to permit the Secretary,
or any Federal officer or employee duly designated by the Secretary, to inspect the laboratory and its operations
and its pertinent records at any reasonable time and to furnish any requested information or materials necessary
to determine the laboratory’s eligibility or continued eligibility for its certificate or continued compliance with
CLIA requirements.
SIGNATURE OF OWNER/DIRECTOR OF LABORATORY (Sign in ink)

DATE

NOTE: Completed 116 applications must be sent to your local State Agency.
SEE ATTACHED LIST OF STATE AGENCY CONTACT INFORMATION.
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a
valid OMB control number. The valid OMB control number for this information collection is 0938-0581. The time required to complete this
information collection is estimated to average 30 minutes to 2 hours per response, including the time to review instructions, search existing
data resources, gather the data needed, and complete and review the information collection. If you have any comments concerning the
accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, Attn: PRA Reports Clearance Officer,
7500 Security Boulevard, Baltimore, Maryland 21244-1850.
Form CMS-116 (01/14)

4

THE CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) APPLICATION

(FORM CMS-116)

INSTRUCTIONS FOR COMPLETION

CLIA requires every facility that tests human specimens
for the purpose of providing information for the
diagnosis, prevention or treatment of any disease or
impairment of, or the assessment of the health of, a
human being to meet certain Federal requirements.
If your facility performs tests for these purposes,
it is considered, under the law, to be a laboratory.
CLIA applies even if only one or a few basic tests
are performed, and even if you are not charging
for testing. In addition the CLIA legislation requires
financing of all regulatory costs through fees assessed
to affected facilities.
The CLIA application (Form CMS-116) collects
information about your laboratory’s operation which
is necessary to determine the fees to be assessed, to
establish baseline data and to fulfill the statutory
requirements for CLIA. This information will also
provide an overview of your facility’s laboratory
operation. All information submitted should be based
on your facility’s laboratory operation as of the date of
form completion.
NOTE: WAIVED TESTS ARE NOT EXEMPT FROM
CLIA. FACILITIES PERFORMING ONLY THOSE TESTS
CATEGORIZED AS WAIVED MUST APPLY FOR A CLIA
CERTIFICATE OF WAIVER.
NOTE: Laboratory directors performing non-waived
testing (including PPM) must meet specific education,
training and experience under subpart M (42 CFR
PART 493) of the CLIA requirements. Proof of these
requirements for the laboratory director must be
submitted with the application. Information to be
submitted with the application include:
•

Verification of State Licensure, as applicable

•

Documentation of qualifications:
• Education (copy of Diploma, transcript from
accredited institution, CMEs),
• Credentials, and
• Laboratory experience.

Individuals who attended foreign schools must have an
evaluation of their credentials determining equivalency
of their education to education obtained in the United
States. Failure to submit this information will delay the
processing of your application.
ALL APPLICABLE SECTIONS MUST BE COMPLETED.
INCOMPLETE APPLICATIONS CANNOT BE PROCESSED
AND WILL BE RETURNED TO THE FACILITY. PRINT
LEGIBLY OR TYPE INFORMATION.
I. GENERAL INFORMATION
For an initial applicant, check “initial application”. For
an initial survey or for a recertification, check “survey”.
For a request to change the type of certificate, check
“change in certificate type” and provide the effective

Form CMS-116 (01/14)

date of the change. For all other changes, including
change in location, director, lab closure, etc., check
“closure/other changes” and provide the effective date
of the change.
CLIA Identification Number: For an initial applicant, the
CLIA number should be left blank. The number will be
assigned when the application is processed. For all other
applicants, enter the 10 digit CLIA identification number
already assigned and listed on your CLIA certificate.
Facility Name: Be specific when indicating the name of
your facility, particularly when it is a component of a
larger entity, e.g., respiratory therapy department in
XYZ Hospital. For a physician’s office, this may be the
name of the physician. NOTE: the information provided
is what will appear on your certificate.
Physical Facility Address: This address is mandatory and
must reflect the physical location where the laboratory
testing is performed. The address may include a floor,
suite and/or room location, but cannot be a Post Office
box or Mail Stop.
If the laboratory has a separate mailing and/or
corporate address (from the Facility Address), please
complete the appropriate sections on the form.
Mailing Address: This address is optional and may be
used if the laboratory wants to direct the mailing of the
CLIA fee coupon and/or CLIA certificate to an alternate
location, such as an accounts payable office. A Post
Office box number or Mail Stop number may be used as
part of the Mailing Address for this section.
Corporate Address: This address is optional and may
be used if the laboratory wants to direct the mailing of
the CLIA fee coupon and/or CLIA certificate to another
location, such as, the main headquarters or home office
for the laboratory. A Post Office box number or Mail
Stop number may be used as part of the Corporate
Address for this section.
Form Mailing: Select the address (Physical, Mailing,
Corporate) where the CLIA fee coupon and CLIA
certificate are to be mailed.
For Office Use Only: The date received is the date the
form is received by the state agency or CMS regional
office for processing.
II. TYPE OF CERTIFICATE REQUESTED
Select your certificate type based on the highest level
of test complexity performed by your laboratory. A
laboratory performing non-waived tests can choose
Certificate of Compliance or Certificate of Accreditation
based on the agency you wish to survey your
laboratory.
When completing this section, please remember that
a facility holding a: Certificate of Waiver can only
perform tests categorized as waived;*

Instructions

•

•

•

Certificate for Provider Performed Microscopy
Procedures (PPM) can only perform tests
categorized as PPM, or tests categorized as PPM and
waived tests;*
Certificate of Compliance can perform tests
categorized as waived, PPM and moderate and/or
high complexity tests provided the applicable CLIA
quality standards are met following a CLIA survey;
and
Certificate of Accreditation can perform tests
categorized as waived, PPM and moderate and/
or high complexity non-waived tests provided the
laboratory is currently accredited by an approved
accreditation organization. (If your CMS-approved
accreditation organization is not listed, contact your
local State Agency for further instructions.)

*A current list of waived and PPM tests may be
obtained from your State agency. Specific test system
categorizations can also be found on the Internet at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfCLIA/clia.cfm.
III. TYPE OF LABORATORY
Select the type that is most descriptive of the location
where the laboratory testing is performed.
If selecting ‘mobile laboratory’ (code 19), a mobile
laboratory is defined as a movable, self-contained
operational laboratory with its own personnel,
equipment, and records. For record keeping purposes,
include, on a separate sheet of paper, the vehicle
identification numbers (VINs) of all vehicles used for
mobile laboratory testing.
If selecting ‘physician office’ (code 21), also answer a
related question regarding ‘shared labs’.
A shared laboratory is when two or more sole
practicing physicians collectively pool resources to fund
one laboratory’s operations. The definition of a shared
laboratory may also include two or more physician
group practices that share the expenses for the
laboratory’s operation.
If selecting ‘Practitioner Other’ (code 22), this type
includes practitioners such as, dentists, chiropractors, etc.

IV. HOURS OF ROUTINE OPERATION
Provide only the times when actual laboratory testing
is performed in your facility. Please use the HH:MM
format and check box marked ‘24/7’ if laboratory
testing is performed continuously, e.g., 24 hours a day,
7 days a week. Do not use military time.
V. MULTIPLE SITES
You can only qualify for the multiple site provision
(more than one site under one certificate) if you meet
one of the CLIA requirements described in 42 CFR 493.
493.35(b)(1-3), 493.43(b)(1-3) and 493.55(b)(1-3)
Hospice and HHA could qualify for an exception.
VI. WAIVED TESTING
Indicate the estimated total annual test volume for all
waived tests performed. List can be found at:
http:www.cms.gov/CLIA/downloads/waivetbl.pdf
VII. PPM TESTING
Indicate the estimated total annual test volume for all
PPM tests performed. List can be found at:
http://www.cms.gov/clia/downloads/ppmp.list.pdf
VIII. NON-WAIVED TESTING (INCLUDING PPM)
The total Estimated Annual Test volume in this section
includes all non-waived testing, including PPM tests
previously counted in section VII. Follow the specific
instructions on page 3 of the Form CMS-116 when
completing this section for test counting information.
(Note: The Accrediting Organization column should
reflect accreditation information for CLIA purposes
only; e.g., CAP, etc.).
IX. TYPE OF CONTROL
Select the type of ownership or control which most
appropriately describes your facility.
X. DIRECTOR OF ADDITIONAL LABORATORIES
List all other facilities for which the director is
responsible and that are under different certificates.
Note that for a Certificate of PPM, Certificate of
Compliance or Certificate of Accreditation, an
individual can only serve as the director for no more
than five certificates.

Once the completed Form CMS-116 has been returned to the applicable State agency and it is processed, a fee remittance
coupon will be issued. The fee remittance coupon will indicate your CLIA identification number and the amount due for the
certificate, and if applicable the compliance (survey) or validation fee. If you are applying for a Certificate of Compliance or
Certificate of Accreditation, you will initially pay for and receive a Registration Certificate. A Registration Certificate permits a
facility requesting a Certificate of Compliance to perform testing until an onsite inspection is conducted to determine program
compliance; or for a facility applying for a Certificate of Accreditation, until verification of accreditation by an approved
accreditation organization is received by CMS.
If you need additional information concerning CLIA, or if you have questions about completion of this form, please contact your State agency.
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf
Form CMS-116 (01/14)

Instructions

VIII. NON-WAIVED TESTING

TESTS COMMONLY PERFORMED AND THEIR CORRESPONDING

LABORATORY SPECIALTIES/SUBSPECIALITIES

HISTOCOMPATIBILITY (010)
HLA Typing (disease associated antigens)
MICROBIOLOGY
Bacteriology (110)
Gram Stain
Culture
Susceptibility
Strep screen
Antigen assays (H.pylori, Chlamydia, etc.)
Mycobacteriology (115)
Acid Fast Smear
Mycobacterial culture
Mycobacterial susceptibility
Mycology (120)
Fungal Culture
DTM
KOH Preps
Parasitology (130)
Direct Preps
Ova and Parasite Preps
Wet Preps
Virology (140)
RSV (Not including waived kits)
HPV assay
Cell culture
DIAGNOSTIC IMMUNOLOGY
Syphilis Serology (210)
RPR
FTA, MHATP
General Immunology (220)
Allergen testing
ANA
Antistreptolysin O
Antigen/Antibody (hepatitis, herpes, rubella, etc.)
Complement (C3, C4)
Immunoglobulin
HIV
Mononucleosis assay
Rheumatoid factor
Tumor marker (AFP, CA 19-9, CA 15-3, CA 125)*

HEMATOLOGY (400)
Complete Blood Count (CBC)
WBC count
RBC count
Hemoglobin
Hematocrit (Not including spun micro)
Platelet count
Differential
Activated Clotting Time
Prothrombin time (Not including waived instruments)
Partial thromboplastin time
Fibrinogen
Reticulocyte count
Manual WBC by hemocytometer
Manual platelet by hemocytometer
Manual RBC by hemocytometer
Sperm count
IMMUNOHEMATOLOGY
ABO group (510)

Rh(D) type (510)

Antibody screening

Antibody identification (540)

Compatibility testing (550)

PATHOLOGY
Dermatopathology

Oral Pathology (620)

PAP smear interpretations (630)

Other Cytology tests (630)

Histopathology (610)

RADIOBIOASSAY (800)
Red cell volume
Schilling test
CLINICAL CYTOGENETICS (900)
Fragile X
Buccal smear
Prader-Willi syndrome
FISH studies for: neoplastic disorders, congenital disorders
or solid tumors.

*Tumor markers can alternatively be listed under
Routine Chemistry instead of General Immunology.

Form CMS-116 (01/14)

Instructions

CHEMISTRY

Routine Chemistry (310)

Albumin
Ammonia
Alk Phos
ALT/SGPT
AST/SGOT
Amylase
Bilirubin
Blood gas (pH, pO2, pCO2)
BUN
Calcium
Chloride
Cholesterol
Cholesterol, HDL
CK/CK isoenzymes
CO2
Creatinine
Ferritin
Folate
GGT
Glucose (Not fingerstick)
Iron
LDH/LDH isoenzymes
Magnesium
Potassium
Protein, electrophoresis
Protein, total
PSA
Sodium
Triglycerides
Troponin
Uric acid
Vitamin B12

Toxicology (340)
Acetaminophen
Blood alcohol
Blood lead (Not waived)
Carbamazepine
Digoxin
Ethosuximide
Gentamicin
Lithium
Phenobarbital
Phenytoin
Primidone
Procainamide
NAPA
Quinidine
Salicylates
Theophylline
Tobramycin
Therapeutic Drug Monitoring
Urinalysis** (320)
Automated Urinalysis (Not including waived instruments)
Microscopic Urinalysis
Urine specific gravity by refractometer
Urine specific gravity by urinometer
Urine protein by sulfosalicylic acid
** Dipstick urinalysis is counted in Section VI. WAIVED TESTING

Endocrinology (330)
Cortisol
HCG (serum pregnancy test)
T3
T3 Uptake
T4
T4, free
TSH

NOTE: This is not a complete list of tests covered by CLIA. Other non-waived tests and their specialties/ subspecialties
can be found at http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/SubjecttoCLIA.pdf
and http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/lccodes.pdf. You may also call
your State agency for further information. State agency contact information can be found at:
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf
Form CMS-116 (01/14)

Instructions

GUIDELINES FOR COUNTING TESTS FOR CLIA

•

For histocompatibility, each HLA typing (including disease associated antigens), HLA antibody screen, or HLA
crossmatch is counted as one test.

•

For microbiology, susceptibility testing is counted as one test per group of antibiotics used to determine
sensitivity for one organism. Cultures are counted as one per specimen regardless of the extent of
identification, number of organisms isolated and number of tests/procedures required for identification.

•

For general immunology, testing for allergens should be counted as one test per individual allergen.

•

For hematology, each measured individual analyte of a complete blood count or flow cytometry test that is
ordered and reported is counted separately. The WBC differential is counted as one test.

•

For immunohematology, each ABO, Rh, antibody screen, crossmatch or antibody identification is counted as
one test.

•

For histopathology, each block (not slide) is counted as one test. Autopsy services are not included. For
those laboratories that perform special stains on histology slides, the test volume is determined by adding
the number of special stains performed on slides to the total number of specimen blocks prepared by
the laboratory.

•

For cytology, each slide (not case) is counted as one test for both Pap smears and nongynecologic cytology.

•

For clinical cytogenetics, the number of tests is determined by the number of specimen types processed on
each patient; e.g., a bone marrow and a venous blood specimen received on one patient is counted as
two tests.

•

For chemistry, each analyte in a profile counts as one test.

•

For urinalysis, microscopic and macroscopia examinations, each count as one test. Macroscopics (dipsticks) are
counted as one test regardless of the number of reagent pads on the strip.

•

For all specialties/subspecialities, do not count calculations (e.g., A/G ratior, MCH, T7, etc.), quality control,
quality assurance, or proficiency testing assays.

If you need additional information concerning counting tests for CLIA, please contact your State agency.
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf

Form CMS-116 (01/14)

Instructions