US · guidance

CMS SOM App. C, Tag D1001

§493.15(e) Laboratories eligible for a certificate of waiver must--

activein force · 2026-07-22 – presentas-observed

(1) Follow manufacturers’ instructions for performing the test; and

(2) Meet the requirements in subpart B, Certificate of Waiver, of this part.

Interpretive Guidelines §493.15(e)

Tests listed on the waiver list in §493.15(c) are not subject to routine survey. A survey

of waived tests may be conducted only when authorized by CMS in the following

instances:

• Determine if a laboratory is testing outside its certificate;

• Collect information regarding the appropriateness of tests specified as waived

tests;

• Investigate a complaint from the public; and/or

• Determine if the laboratory is operated and if testing is performed in a manner

that does not constitute an imminent and serious risk to public health.

Refer to §§493.1773 and 493.1775 for additional guidelines for inspecting laboratories

issued a certificate of waiver.

Laboratories holding a certificate of waiver must follow the current manufacturer’s

instructions for the waived test systems they are using for patient testing. To meet the

waived testing regulatory requirements, these laboratories must comply with the

manufacturer’s requirements. We encourage laboratories to also comply with the

manufacturer’s recommendations for testing. These laboratories may only use the

specimen types that were approved by the Food and Drug Administration (FDA) with the

waived test system they are using, and they must follow the manufacturer’s quality

control (QC) and test performance requirements. We encourage laboratories to also

comply with manufacturer’s recommendations for the waived test system. Some

manufacturers produce tests that can be run as a waived test or a moderate complexity

test. Any laboratory with a certificate of waiver that uses the nonwaived test system

instructions from a manufacturer should be advised that they must use the manufacturer’s

instructions for waived testing. If the situation remains uncorrected, the laboratory may

be cited for performing tests beyond the scope of the certificate held by the laboratory, as

well as failing to follow manufacturer’s instructions.

NOTE: It is never acceptable for a laboratory operating under a certificate of waiver to

modify the manufacturer’s instructions for the waived test system. Any such changes

will result in a test that is no longer waived (i.e., the waived test is uncategorized for

CLIA and therefore becomes a high complexity test). For example, if a test specifies

urine as the waived specimen type and the laboratory tests a different body fluid, then the

laboratory is no longer performing a waived test and the lab is then subject to routine

inspections and the CLIA requirements for high complexity testing. Waived laboratory

testing personnel must follow the manufacturer’s instructions in their entirety and without

variation. Great care should be taken to add the proper reagents in the order and amount

specified by the manufacturer’s instructions to ensure compliance with the CLIA

regulations and reliable test results.

§493.17 Test categorization

(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)

(a) Categorization by criteria. Notices will be published in the FEDERAL

by complexity. Using the seven criteria specified in this paragraph for categorizing

tests of moderate or high complexity, each specific laboratory test system, assay, and

examination will be graded for level of complexity by assigning scores of 1, 2, or 3

within each criteria. The score of “1” indicates the lowest level of complexity, and

the score of “3” indicates the highest level. These scores will be totaled. Test

systems, assays or examinations receiving scores of 12 or less will be categorized as

moderate complexity, while those receiving scores above 12 will be categorized as

high complexity.

NOTE: A score of “2” will be assigned to a criteria heading when the

characteristics for a particular test are intermediate between the description listed

for scores of “1” and “3.”

(1) Knowledge.

(i) Score 1.

(A) Minimal scientific and technical knowledge is required to perform the

test; and

(B) Knowledge required to perform the test may be obtained through on-the-job instruction.

(ii) Score 3. Specialized scientific and technical knowledge is essential to

perform preanalytic, analytic or postanalytic phases of the testing.

(2) Training and experience.

(i) Score 1.

(A) Minimal training is required for preanalytic, analytic and postanalytic

phases of the testing process; and

(B) Limited experience is required to perform the test.

(ii) Score 3.

(A) Specialized training is essential to perform the preanalytic, analytic or

postanalytic testing process; or

(B) Substantial experience may be necessary for analytic test performance.

(3) Reagents and materials preparation.

(i) Score 1.

(A) Reagents and materials are generally stable and reliable; and

(B) Reagents and materials are prepackaged, or premeasured, or require no

special handling, precautions or storage conditions.

(ii) Score 3.

(A) Reagents and materials may be labile and may require special handling

to assure reliability; or

(B) Reagents and materials preparation may include manual steps such as

gravimetric or volumetric measurements.

(4) Characteristics of operational steps.

(i) Score l. Operational steps are either automatically executed (such as

pipetting, temperature monitoring, or timing of steps), or are easily

controlled.

(ii) Score 3. Operational steps in the testing process require close monitoring

or control, and may require special specimen preparation, precise

temperature control or timing of procedural steps, accurate pipetting, or

extensive calculations.

(5) Calibration, quality control, and proficiency testing materials.

(i) Score 1.

(A) Calibration materials are stable and readily available;

(B) Quality control materials are stable and readily available; and

(ii) Score 3.

(A) Calibration materials, if available, may be labile;

(B) Quality control materials may be labile, or not available; or

(6) Test system troubleshooting and equipment maintenance.

(i) Score l.

(A) Test system troubleshooting is automatic or self-correcting, or clearly

described or requires minimal judgment; and

(B) Equipment maintenance is provided by the manufacturer, is seldom

needed, or can easily be performed.

(ii) Score 3.

(A) Troubleshooting is not automatic and requires decision-making and

direct intervention to resolve most problems; or

(B) Maintenance requires special knowledge, skills, and abilities.

(7) Interpretation and judgment.

(i) Score 1.

(A) Minimal interpretation and judgment are required to perform

preanalytic, analytic and postanalytic processes; and

(B) Resolution of problems requires limited independent interpretation and

judgment; and

(ii) Score 3.

(A) Extensive independent interpretation and judgment are required to

perform the preanalytic, analytic or postanalytic processes; and

(B) Resolution of problems requires extensive interpretation and judgment.

(b) Revisions to the criteria for categorization

The Clinical Laboratory Improvement Advisory Committee, as defined in subpart

T of this part, will conduct reviews upon request of HHS and recommend to HHS

revisions to the criteria for categorization of tests.

under §493.17(a). (1)(i) For new commercial test systems, assays, or

examinations, the manufacturer, as part of its 510(k) and PMA application to FDA,

will submit supporting data for device/test categorization. FDA will determine the

complexity category, notify the manufacturers directly, and will simultaneously

inform both CMS and CDC of the device/test category. FDA will consult with CDC

concerning test categorization in the following three situations:

(A) When categorizing previously uncategorized new technology;

(B) When FDA determines it to be necessary in cases involving a request for

a change in categorization; and

accordance with 21 CFR 10.75.

(ii) Test categorization will be effective as of the notification to the applicant.

(2) For test systems, assays, or examinations not commercially available, a

laboratory or professional group may submit a written request for categorization to

PHS. These requests will be forwarded to CDC for evaluation; CDC will determine

complexity category and notify the applicant, CMS, and FDA of the categorization

decision. In the case of request for a change of category or for previously

uncategorized new technology, PHS will receive the request application and forward

it to CDC for categorization.

(3) A request for recategorization will be accepted for review if it is based on new

information not previously submitted in a request for categorization or

recategorization by the same applicant and will not be considered more frequently

than once per year.

(4) If a laboratory test system, assay or examination does not appear on the lists of

tests in the FEDERAL REGISTER notices, it is considered to be a test of high

complexity until PHS, upon request, reviews the matter and notifies the applicant of

its decision. Test categorization is effective as of the notification to the applicant.

(5) PHS will publish revisions periodically to the list of moderate and high

complexity tests in the FEDERAL REGISTER in a notice with opportunity for

comment.

Interpretive Guidelines §493.17(c)(5)

To determine which tests are categorized as waived or nonwaived (i.e., moderate or high

complexity tests), refer to the following web link for the FDA categorization database

(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm?sAN=0). Test

systems, assays, and examinations not yet classified are considered high complexity.

Significant deficiencies cited under this condition may also indicate deficiencies under

personnel responsibilities.

NOTE: A modified waived or moderate complexity test (including modifications in its

intended use) is considered uncategorized for CLIA purposes and therefore becomes a

high complexity test.

§493.19 Provider-performed microscopy (PPM) procedures

(Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)

(a) Requirement. To be categorized as a PPM procedure, the procedure must meet

the criteria specified in paragraph (b) of this section.

(b) Criteria. Procedures must meet the following specifications:

(1) The examination must be personally performed by one of the following

practitioners:

(i) A physician during the patient’s visit on a specimen obtained from his or her own

patient or from a patient of a group medical practice of which the physician is a

member or an employee.

(ii) A midlevel practitioner, under the supervision of a physician or in independent

practice only if authorized by the State, during the patient’s visit on a specimen

obtained from his or her own patient or from a patient of a clinic, group medical

practice, or other health care provider of which the midlevel practitioner is a

member or an employee.

(iii) A dentist during the patient’s visit on a specimen obtained from his or her own

patient or from a patient of a group dental practice of which the dentist is a member

or an employee.

(2) The procedure must be categorized as moderately complex.

(3) The primary instrument for performing the test is the microscope, limited to

bright-field or phase-contrast microscopy.

(4) The specimen is labile or delay in performing the test could compromise the

accuracy of the test result.

(5) Control materials are not available to monitor the entire testing process.

Interpretive Guidelines for 493.19(b)(5)

Refer to the interpretive guidelines at 493.1256(h) for more guidance on PPM quality

control.

(6) Limited specimen handling or processing is required.

to perform tests under this section if it restricts PPM examinations to one or more of

the following procedures (or additional procedures added to this list as provided

under paragraph (d) of this section), waived tests and no others:

(1) All direct wet mount preparations for the presence or absence of bacteria,

fungi, parasites, and human cellular elements.

Interpretive Guideline for 493.19(c)(1)

All direct wet mounts for scabies (which includes mineral oil preparations) are PPM

examinations. All direct wet mount preparations for the presence or absence of bacteria,

fungi, parasites, and human cellular elements include the direct wet mount examinations

for Clue cells. Clue cells are vaginal epithelial cells covered with bacteria.

(2) All potassium hydroxide (KOH) preparations.

Interpretive Guideline for 493.19(c)(2)

All KOH preparations include KOH that is mixed directly with a stain or the stain is a

drop added directly to the KOH preparation and the slide is examined with bright-field

microscopy.

(3) Pinworm examinations.

(4) Fern tests.

(5) Post-coital direct, qualitative examinations of vaginal or cervical mucous.

(6) Urine sediment examinations.

Interpretive Guideline for 493.19(c)(6)

It is acceptable in a PPM laboratory to add stain to resuspend the urine sediment to assist

in identifying the formed elements in the urine.

(7) Nasal smears for granulocytes.

(8) Fecal leukocyte examinations.

(9) Qualitative semen analysis (limited to the presence or absence of sperm and

detection of motility).

(d) Revision to criteria and the list of PPM procedures

(1) The CLIAC conducts reviews upon HHS’ request and recommends to HHS

revisions to the criteria for categorization of procedures.

(2) HHS determines whether a laboratory procedure meets the criteria listed under

paragraph (b) of this section for a PPM procedure. Revisions to the list of PPM

procedures proposed by HHS are published in the FEDERAL REGISTER as a

notice with an opportunity for public comment.

(e) Laboratory requirements

Laboratories eligible to perform PPM examinations must--

(1) Meet the applicable requirements in subpart C or subpart D, and subparts F, H,

J, K, and M of this part.

(2) Be subject to inspection as specified under subpart Q of this part.

§493.20 Laboratories performing tests of moderate complexity

(Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)

(a) A laboratory may qualify for a certificate to perform tests of moderate

complexity provided that it restricts its test performance to waived tests or

examinations and one or more tests or examinations meeting criteria for tests

of moderate complexity including the subcategory of PPM procedures.

(b) A laboratory that performs tests or examinations of moderate complexity

must meet the applicable requirements in subpart C or subpart D, and

subparts F, H, J, K, M, and Q of this part. Under a registration certificate or

certificate of compliance, laboratories also performing PPM procedures must

meet the inspection requirements at §§493.1773 and 493.1777.

and (b)(7) and subparts J, K, and M of this part is not applicable to the

waived tests. However, the laboratory must comply with the requirements in

§§ 493.15(e), 493.801(b)(1) through (6), 493.1771, 493.1773, and 493.1775.

§493.25 Laboratories performing tests of high complexity

(Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)

(a) A laboratory must obtain a certificate for tests of high complexity if it

performs one or more tests that meet the criteria for tests of high complexity

as specified in §493.17(a).

(b) A laboratory performing one or more tests of high complexity must meet the

applicable requirements of subpart C or subpart D, and subparts F, H, J, K,

M, and Q of this part.

requirements of subparts H, J, K, M, and Q of this part must be met. Under

a registration certificate or certificate of compliance, PPM procedures must

meet the inspection requirements in §§493.1773 and 493.1777.

(d) If the laboratory also performs waived tests, compliance with §§ 493.801(a)

and 493.801(b)(7) and subparts J, K, and M of this part are not applicable to

the waived tests. However, the laboratory must comply with the

requirements in §§493.15(e), 493.801(b)(1) through (6), 493.1771, 493.1773

and 493.1775.

Subpart B--Certificate of Waiver

§493.35 Application for a certificate of waiver

(Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)

(a) Filing of application.

Except as specified in paragraph (b) of this section, a laboratory performing only

one or more waived tests listed in §493.15 must file a separate application for each

laboratory location.

Interpretive Guidelines §493.35(a)

NOTE: See section 6036 of the SOM for instructions on handling a laboratory operating

without a CLIA certificate. Per policy letter QSO18-20-CLIA, multiple laboratories with

separate CLIA numbers may operate at one location as long as it can be demonstrated

that each laboratory is operating as a separate and distinct entity.

(b) Exceptions

(1) Laboratories that are not at a fixed location, that is, laboratories that move

from testing site to testing site, such as mobile units providing laboratory testing,

health screening fairs, or other temporary testing locations may be covered

under the certificate of the designated primary site or home base, using its

address.

Interpretive Guidelines §493.35(b)(1)

A mobile unit is a laboratory located within a self-contained vehicle, such as a van. The

vehicle moves from location to location to perform laboratory testing activities. Mobile

vans will be distinguished by the vehicle identification number (VIN#).

If a mobile laboratory operates in more than one State and does not obtain a separate

certificate from each State, contact CMS to determine which State conducts the

inspection. See section 6010.1.1 of the SOM for additional information on mobile

laboratories.

Each laboratory that moves from testing site to testing site, or has a temporary testing

location, should provide the survey agency with the home base or central dispatch phone

number and the locations where additional testing is performed.

A temporary testing site is considered a location not used to permanently house

instruments, equipment, personnel and records, e.g., a health fair. See section 6010.1.2 of

the SOM for further guidance.

See section 6010.1.2.1 of the SOM for guidance for Home Health Agencies with multiple

sites.

(2) Not-for-profit or Federal, State, or local government laboratories that

engage in limited (not more than a combination of 15 moderately complex or

waived tests per certificate) public health testing may file a single application.

Interpretive Guidelines §493.35(b)(2)

See section 6010.2 of the SOM for the definition for limited public health testing. Note

that laboratories operating under a certificate of waiver may not perform moderate or

high complexity testing.

(3) Laboratories within a hospital that are located at contiguous buildings on the

same campus and under common direction may file a single application or

multiple applications for the laboratory sites within the same physical

location or street address.

Interpretive Guidelines §493.35(b)(3)

Common direction means that all testing sites are under one designated director.

Street address is the address assigned by the Post Office and is the physical location of

the laboratory. The street address may be different from the mailing address, which can

be a Post Office box or a billing address. For large hospitals, such as a university campus

facility, that may contain laboratories in separate buildings, consult with CMS to

determine if the hospital is eligible for a single certificate.

The application must--

(1) Be made to HHS or its designee on a form or forms prescribed by HHS;

(2) Be signed by an owner, or by an authorized representative of the

laboratory who attests that the laboratory will be operated in accordance

with requirements established by the Secretary under section 353 of the

PHS Act; and

(3) Describe the characteristics of the laboratory operation and the

examinations and other test procedures performed by the laboratory

including--

(i) The name and the total number of test procedures and examinations

performed annually (excluding tests the laboratory may run for quality

control, quality assurance or proficiency testing purposes;

(ii) The methodologies for each laboratory test procedure or examination

performed, or both; and

(iii) The qualifications (educational background, training, and experience) of

the personnel directing and supervising the laboratory and performing

the laboratory examinations and test procedures.

(d) Access requirements

Laboratories that perform one or more waived tests listed in §493.15(c) and no

other tests must meet the following conditions:

Interpretive Guidelines §493.35(d)

Cite deficiencies for not following manufacturer’s instructions at §493.15(e). (Use

D1001)

(1) Make records available and submit reports to HHS as HHS may reasonably

require to determine compliance with this section and §493.15(e);

(2) Agree to permit announced and unannounced inspections by HHS in

accordance with subpart Q of this part under the following circumstances:

(i) When HHS has substantive reason to believe that the laboratory is being

operated in a manner that constitutes an imminent and serious risk to

human health.

Interpretive Guidelines §493.35(d)(2)(i)

Consult with CMS for assistance in determining when there is substantive reason to

believe that the laboratory is being operated in a manner that constitutes an imminent and

serious risk to human health.

An example of a substantive reason to inspect waived testing is if testing personnel are

observed cutting urine dipsticks in half. (This violates both the manufacturer’s

instructions and causes questionable results to be reported.)

(ii) To evaluate complaints from the public.

(iii) On a random basis to determine whether the laboratory is performing

tests not listed in §493.15.

Interpretive Guidelines §493.35(d)(2)(ii)-(iii)

NOTE: See Chapter 5 of the SOM for specific procedures regarding complaint

investigations.

(iv) To collect information regarding the appropriateness of waiver of tests

listed in §493.15.

(e) Denial of application

If HHS determines that the application for a certificate of waiver is to be denied,

HHS will--

(1) Provide the laboratory with a written statement of the grounds on which

the denial is based and an opportunity for appeal, in accordance with the

procedures set forth in subpart R of this part;

(2) Notify a laboratory that has its application for a certificate of waiver

denied that it cannot operate as a laboratory under the PHS Act unless

the denial is overturned at the conclusion of the administrative appeals

process provided by subpart R; and

(3) Notify the laboratory that it is not eligible for payment under the

Medicare and Medicaid programs.

§493.37 Requirements for a certificate of waiver

(Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)

(a) HHS will issue a certificate of waiver to a laboratory only if the laboratory meets

the requirements of §493.35.

(b) Laboratories issued a certificate of waiver--

(1) Are subject to the requirements of this subpart and §493.15(e) of subpart A of

this part; and

Interpretive Guidelines §493.37(b)(1)

Cite the laboratory’s failure to follow manufacturer’s instructions at §493.15(e). (Use

D1001.)

(2) Must permit announced or unannounced inspections by HHS in accordance with

subpart Q of this part.

this part.

(d) In accordance with subpart R of this part, HHS will suspend or revoke or limit a

laboratory’s certificate of waiver for failure to comply with the requirements of this

subpart. In addition, failure to meet the requirements of this subpart will result in

suspension or denial of payments under Medicare and Medicaid in accordance with

subpart R of this part.

Interpretive Guidelines §493.37(d)

NOTE: See the Adverse Action section of the SOM beginning at section 6250 for

enforcement procedures.

(e)(1) A certificate of waiver issued under this subpart is valid for no more than 2

years. In the event of a non-compliance determination resulting in HHS action to

revoke, suspend, or limit the laboratory’s certificate of waiver, HHS will provide the

laboratory with a statement of grounds on which the determination of noncompliance is based and offer an opportunity for appeal as provided in subpart R of

this part.

(2) If the laboratory requests a hearing within the time specified by HHS, it retains

its certificate of waiver or reissued certificate of waiver until a decision is made by

an administrative law judge, as specified in subpart R of this part, except when

HHS finds that conditions at the laboratory pose an imminent and serious risk to

human health.

(3) For laboratories receiving payment from the Medicare or Medicaid program,

such payments will be suspended on the effective date specified in the notice to the

laboratory of a non-compliance determination even if there has been no appeals

decision issued.

(f) A laboratory seeking to renew its certificate of waiver must--

(1) Complete the renewal application prescribed by HHS and return it to HHS not

less than 9 months nor more than 1 year before the expiration of the certificate; and

(2) Meet the requirements of §§493.35 and 493.37.

§493.37(g) A laboratory with a certificate of waiver that wishes to perform

examinations or tests not listed in the waiver test category must meet the

requirements set forth in subpart C or subpart D of this part, as applicable.

§493.39 Notification requirements for laboratories issued a certificate of

waiver

(Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)

Laboratories performing one or more tests listed in §493.15 and no others must

notify HHS or its designee--

(a) Before performing and reporting results for any test or examination that is not

specified under §493.15 for which the laboratory does not have the appropriate

certificate as required in subpart C or subpart D of this part, as applicable; and

Interpretive Guidelines §493.39(a)

NOTE: See section 6036 of the SOM for instructions on handling a laboratory operating

without an appropriate CLIA certificate.

(b) Within 30 days of any change(s) in--

(1) Ownership;

(2) Name;

(3) Location; or

(4) Director.

Interpretive Guidelines §493.39(b)

NOTE: See section 6016 of the SOM for applicable instructions on handling changes in

ownership, name, location, or director.

Because there is no D-tag assigned to this regulation, you may use D0000 to cite noncompliance with this requirement.

Subpart C--Registration Certificate, Certificate for Provider-Performed Microscopy Procedures, and Certificate of

Compliance

§493.43 Application for registration certificate, certificate for provider-performed microscopy (PPM) procedures, and certificate of compliance

(Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)

(a) Filing of application

Except as specified in paragraph (b) of this section, all laboratories performing

nonwaived testing must file a separate application for each laboratory location.

Interpretive Guidelines §493.43(a)

NOTE: See section 6036 of the SOM for instructions on handling a laboratory operating

without a CLIA certificate. Per policy letter ﷟QSO 18-20 CLIA, multiple laboratories

with separate CLIA numbers may operate at one location as long as it can be

demonstrated that each laboratory is operating as a separate and distinct entity.

(b) Exceptions

(1) Laboratories that are not at a fixed location, that is, laboratories that move from

testing site to testing site, such as mobile units providing laboratory testing, health

screening fairs, or other temporary testing locations may be covered under the

certificate of the designated primary site or home base, using its address.

Interpretive Guidelines §493.43(b)(1)

A mobile unit is a laboratory located within a self-contained vehicle, such as a van. The

vehicle moves from location to location to perform laboratory testing activities. Mobile

vans will be distinguished by the vehicle identification number (VIN#).

If a mobile laboratory operates in more than one State and does not obtain a separate

certificate for each State, contact CMS to determine which State conducts the inspection.

See section 6010.1.1 of the SOM for additional information on mobile laboratories.

Each laboratory that moves from testing site to testing site, or has a temporary testing

location, should provide the survey agency with the home base or central dispatch phone

number and the locations where additional testing is performed.

A temporary testing site is considered a location not used to permanently house

instruments, equipment, personnel and records, e.g., a health fair. See §6036.3 of the

SOM for further guidance.

NOTE: See section 6010.1.2.1 of the SOM for guidance for home health agencies with

multiple sites.

(2) Not-for-profit or Federal, State, or local government laboratories that engage in

limited (not more than a combination of 15 moderately complex or waived tests per

certificate) public health testing may file a single application.

Interpretive Guidelines §493.43(b)(2)

NOTE: See section 6010.2 of the SOM for information on limited public health testing.

(3) Laboratories within a hospital that are located at contiguous buildings on the

same campus and under common direction may file a single application or multiple

applications for the laboratory sites within the same physical location or street

address.

Interpretive Guidelines §493.43(b)(3)

In instances where the main laboratory is certified to perform waived, moderate and/or

high complexity tests, the alternate sites may perform testing in all complexities covered

by the certificate provided that all other applicable requirements are met (e.g., quality

control, personnel).

Common direction means that all sites are under one designated director.

Street address is the address assigned by the Post Office and is the physical location of

the laboratory. The street address may be different from the mailing address, which can

be a Post Office box or a billing address. For large hospitals, such as a university campus

facility, that may contain laboratories in separate buildings, consult with CMS to

determine if the hospital is eligible for a single certificate.

The application must--(1) Be made to HHS or its designee on a form or forms

prescribed by HHS;

(2) Be signed by an owner, or by an authorized representative of the laboratory who

attests that the laboratory will be operated in accordance with the requirements

established by the Secretary under section 353 of the Public Health Service Act; and

(3) Describe the characteristics of the laboratory operation and the examinations

and other test procedures performed by the laboratory including--

(i) The name and total number of test procedures and examinations

performed annually (excluding waived tests or tests for quality control,

quality assurance or proficiency testing purposes);

(ii) The methodologies for each laboratory test procedure or examination

performed, or both;

(iii) The qualifications (educational background, training, and experience) of

the personnel directing and supervising the laboratory and performing

the examinations and test procedures.

(d) Access and reporting requirements

All laboratories must make records available and submit reports to HHS as HHS

may reasonably require to determine compliance with this section.

§493.45 Requirements for a registration certificate

(Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)

Laboratories performing only waived tests, PPM procedures, or any combination of

these tests, are not required to obtain a registration certificate.

(a) A registration certificate is required—

(1) Initially for all laboratories performing test procedures of moderate complexity

(other than the subcategory of PPM procedures) or high complexity, or both; and

(2) For all laboratories that have been issued a certificate of waiver or certificate

for PPM procedures that intend to perform tests of moderate or high complexity, or

both, in addition to those tests listed in §493.15 (c) or specified as PPM procedures.

Interpretive Guidelines §493.45(a)

All facilities performing laboratory testing must have a registration, compliance or

accreditation certificate, a certificate for provider-performed microscopy procedures or a

certificate of waiver prior to performing patient testing.

NOTE: See section 6036 of the SOM for instructions on handling a laboratory operating

without an appropriate CLIA certificate.

(b) HHS will issue a registration certificate if the laboratory--

(1) Complies with the requirements of §493.43;

(2) Agrees to notify HHS or its designee within 30 days of any changes in ownership,

name, location, director or technical supervisor (laboratories performing high

complexity testing only);

(3) Agrees to treat proficiency testing samples in the same manner as it treats

patient specimens; and

(4) Remits the fee for the registration certificate, as specified in subpart F of this

part.

(1) Remit the certificate fee specified in subpart F of this part;

(2) Be inspected by HHS as specified in subpart Q of this part; and

(3) Demonstrate compliance with the applicable requirements of this subpart and

subparts H, J, K, M, and Q of this part.

(d) In accordance with subpart R of this part, HHS will initiate suspension or

revocation of a laboratory’s registration certificate and will deny the laboratory’s

application for a certificate of compliance for failure to comply with the

requirements set forth in this subpart. HHS may also impose certain alternative

sanctions. In addition, failure to meet the requirements of this subpart will result in

suspension of payments under Medicare and Medicaid as specified in subpart R of

this part.

(e) A registration certificate is--

(1) Valid for a period of no more than two years or until such time as an inspection

to determine program compliance can be conducted, whichever is shorter; and

(2) Not renewable; however, the registration certificate may be reissued if

compliance has not been determined by HHS prior to the expiration date of the

registration certificate.

(f) In the event of a noncompliance determination resulting in an HHS denial of a

laboratory’s certificate of compliance application, HHS will provide the laboratory

with a statement of grounds on which the noncompliance determination is based

and offer an opportunity for appeal as provided in subpart R.

Interpretive Guidelines §493.45(f)

NOTE: See the Appeals section of the SOM beginning at sections 6258 and 6300 for

instructions on denial of a certificate application.

(g) If the laboratory requests a hearing within the time specified by HHS, it retains

its registration certificate or reissued registration certificate until a decision is made

by an administrative law judge as provided in subpart R of this part, except when

HHS finds that conditions at the laboratory pose an imminent and serious risk to

human health.

(h) For laboratories receiving payment from the Medicare or Medicaid program,

such payments will be suspended on the effective date specified in the notice to the

laboratory of denial of the certificate application even if there has been no appeals

decision issued.

§493.47 Requirements for a certificate for provider-performed

microscopy (PPM) procedures.

(Rev. 236; Issued: 01-23-26; Effective: 09-12-25; Implementation: 09-12-25)

(a) A certificate for PPM procedures is required-

(1) Initially for all laboratories performing test procedures specified as PPM

procedures; and

(2) For all certificate of waiver laboratories that intend to perform only test

procedures specified as PPM procedures in addition to those tests listed in

§493.15(c).

(b) HHS will issue a certificate for PPM procedures if the laboratory-

(1) Complies with the requirements of §493.43; and

(2) Remits the fee for the certificate, as specified in subpart F of this part.

(1) The notification requirements of §493.53;

(2) The applicable requirements of this subpart and subparts H, J, K, and M of this

part; and

(3) Inspection only under the circumstances specified under §§493.1773 and

493.1775, but are not routinely inspected to determine compliance with the

requirements specified in paragraphs (c)(1) and (2) of this section.

(d) In accordance with subpart R of this part, HHS will initiate suspension,

limitation, or revocation of a laboratory’s certificate for PPM procedures for failure

to comply with the applicable requirements set forth in this subpart. HHS may also

impose certain alternative sanctions. In addition, failure to meet the requirements of

this subpart may result in suspension of all or part of payments under Medicare and

Medicaid, as specified in subpart R of this part.

(e) A certificate for PPM procedures is valid for a period of no more than 2 years.

§493.49 Requirements for a certificate of compliance.

(Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)

A certificate of compliance may include any combination of tests categorized as high

complexity or moderate complexity or listed in §493.15(c) as waived tests. Moderate

complexity tests may include those specified as PPM procedures.

(a) HHS will issue a certificate of compliance to a laboratory only if the laboratory--

(1) Meets the requirements of §§493.43 and 493.45;

(2) Remits the certificate fee specified in subpart F of this part; and

(3) Meets the applicable requirements of this subpart and subparts H, J, K, M, and

Q of this part.

(b) Laboratories issued a certificate of compliance--

(1) Are subject to the notification requirements of §493.51; and

(2) Must permit announced or unannounced inspections by HHS in accordance with

subpart Q of this part--

(i) To determine compliance with the applicable requirements of this part;

(ii) To evaluate complaints;

(iii) When HHS has substantive reason to believe that tests are being performed, or

the laboratory is being operated in a manner that constitutes an imminent and

serious risk to human health; and

(iv) To collect information regarding the appropriateness of tests listed in §493.15 or

tests categorized as moderate complexity (including the subcategory) or high

complexity.

(1) Suspension, revocation or limitation of a laboratory’s certificate of compliance in

accordance with subpart R of this part; and

(2) Suspension or denial of payments under Medicare and Medicaid in accordance

with subpart R of this part.

(d) A certificate of compliance issued under this subpart is valid for no more than 2

years.

(e) In the event of a noncompliance determination resulting in an HHS action to

revoke, suspend or limit the laboratory’s certificate of compliance, HHS will--

(1) Provide the laboratory with a statement of grounds on which the determination

of noncompliance is based; and

(2) Offer an opportunity for appeal as provided in subpart R of this part. If the

laboratory requests a hearing within 60 days of the notice of sanction, it retains its

certificate of compliance or reissued certificate of compliance until a decision is

made by an administrative law judge (ALJ) as provided in subpart R of this part,

except when HHS finds that conditions at the laboratory pose an imminent and

serious risk to human health or when the criteria at §493.1840(a)(4) and (5) are met.

(f) For laboratories receiving payment from the Medicare or Medicaid program,

such payments will be suspended on the effective date specified in the notice to the

laboratory of a noncompliance determination even if there has been no appeals

decision issued.

(g) A laboratory seeking to renew its certificate of compliance must--

(1) Complete and return the renewal application to HHS 9 to 12 months prior to the

expiration of the certificate of compliance; and

(2) Meet the requirements of §493.43 and paragraphs (a)(2) and (b)(2) of this

section.

(h) If HHS determines that the application for the renewal of a certificate of

compliance must be denied or limited, HHS will notify the laboratory in writing of

the--

(1) Basis for denial of the application; and

(2) Opportunity for appeal as provided in subpart R of this part.

Interpretive Guidelines §493.49(h)(2)

NOTE: See the Appeals section of the SOM beginning at sections 6258 and 6300 for

instructions on denial of a certificate application.

(i) If the laboratory requests a hearing within the time period specified by HHS, the

laboratory retains its certificate of compliance or reissued certificate of compliance

until a decision is made by an ALJ as provided in subpart R, except when HHS

finds that conditions at the laboratory pose an imminent and serious risk to human

health.

(j) For laboratories receiving payment from the Medicare or Medicaid program,

such payments will be suspended on the effective date specified in the notice to the

laboratory of nonrenewal of the certificate of compliance even if there has been no

appeals decision issued.

§493.51 Notification requirements for laboratories issued a certificate of

compliance

(Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)

Laboratories issued a certificate of compliance must meet the following conditions:

(a) Notify HHS or its designee within 30 days of any change in--

(1) Ownership;

(2) Name;

(3) Location;

(4) Director; or

(5) Technical supervisor (laboratories performing high complexity only).

(b) Notify HHS no later than 6 months after performing any test or examination

within a specialty or subspecialty area that is not included on the laboratory’s

certificate of compliance, so that compliance with requirements can be determined.

methodologies for any test or examination included in a specialty or subspecialty, or

both, for which the laboratory has been issued a certificate of compliance.

Interpretive Guidelines §493.51(a)-(c)

See the section of the SOM beginning at section 6016 for handling changes in ownership,

name, location, personnel and test methodology, or additions or deletions of specialties or

subspecialties that may result in changes in complexity levels for the laboratory.

See the SOM beginning at section 6260 for instructions on handling laboratories that are

going out of business or voluntarily withdrawing from all testing, including laboratories

that are taking these actions while an enforcement action is pending.

Because there is no D-tag assigned to this regulation, you may use D0000 to cite noncompliance with this requirement.

§493.53 Notification requirements for laboratories issued a certificate

for provider-performed microscopy (PPM) procedures

(Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)

Laboratories issued a certificate for PPM procedures must notify HHS or its

designee--

(a) Before performing and reporting results for any test of moderate or high

complexity, or both, in addition to tests specified as PPM procedures or any test or

examination that is not specified under §493.15(c), for which it does not have a

registration certificate as required in subpart C or subpart D, as applicable, of this

part; and

(b) Within 30 days of any change in--

(1) Ownership;

(2) Name;

(3) Location; or

(4) Director

Interpretive Guidelines §493.53(b)

See the section of the SOM beginning at section 6016 for handling changes in ownership,

name, location, personnel and test methodology, or additions or deletions of specialties or

subspecialties that may result in changes in complexity levels for the laboratory.

See the SOM beginning at section 6260 for instructions on handling laboratories that are

going out of business or voluntarily withdrawing from all testing, including laboratories

that are taking these actions while an enforcement action is pending.

Because there is no D-tag assigned to this regulation, you may use D0000 to cite noncompliance with this requirement.

Subpart D--Certificate of Accreditation

§493.55 Application for registration certificate and certificate of

accreditation

(Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)

(a) Filing of application

A laboratory may be issued a certificate of accreditation in lieu of the applicable

certificate specified in subpart B or subpart C of this part provided the laboratory--

(1) Meets the standards of a private non-profit accreditation program

approved by HHS in accordance with subpart E; and

Interpretive Guidelines §493.55(a)(1)

When HHS approves accreditation organizations and State licensure programs, CMS is

notified and the approved organizations and programs are published as a notice in the

FEDERAL REGISTER.

NOTE: See sections 6150-6151 of the SOM.

(2) Files a separate application for each location, except as specified in

paragraph (b) of this section.

Interpretive Guidelines §493.55(a)(2)

See section 6036 of the SOM for instructions on handling a laboratory operating without

a CLIA certificate. Per policy letter ﷟QSO 18-20 CLIA, multiple laboratories with

separate CLIA numbers may operate at one location as long as it can be demonstrated

that each laboratory is operating as a separate and distinct entity.

(b) Exceptions

(1) Laboratories that are not at fixed locations, that is, laboratories that move

from testing site to testing site, such as mobile units providing laboratory

testing, health screening fairs, or other temporary testing locations may

be covered under the certificate of the designated primary site or home

base, using its address.

Interpretive Guidelines §493.55(b)(1)

A mobile unit is a laboratory located within a self-contained vehicle, such as a van. The

vehicle moves from location to location to perform laboratory testing activities. Mobile

vans will be distinguished by the vehicle identification number (VIN#).

If a mobile laboratory operates in more than one State and does not obtain a separate

certificate from each State, contact CMS to determine which State conducts the

inspection. See section 6010.1.1 of the SOM for additional information on mobile

laboratories.

Each laboratory that moves from testing site to testing site, or has a temporary testing

location, should provide the survey agency with the home base or central dispatch phone

number and the locations where additional testing is performed.

A temporary testing site is considered a location not used to permanently house

instruments, equipment, personnel and records, e.g., a health fair. See section 6036.3 of

the SOM for further guidance.

See section 6010.1.2.1 of the SOM for guidance for home health agencies with multiple

sites.

(2) Not-for-profit or Federal, State, or local government laboratories that

engage in limited (not more than a combination of 15 moderately complex

or waived tests per certificate) public health testing may file a single

application.

Interpretive Guidelines §493.55(b)(2)

See section 6010.2 of the SOM for the definition of limited public health testing.

(3) Laboratories within a hospital that are located at contiguous buildings on

the same campus and under common direction may file a single

application or multiple applications for the laboratory sites within the

same physical location or street address.

Interpretive Guidelines §493.55(b)(3)

Common direction means that all sites are under one designated director.

Street address is the address assigned by the Post Office and is the physical location of

the laboratory. The street address may be different from the mailing address, which can

be a Post Office box or a billing address. For large hospitals, such as a university campus

facility, that may contain laboratories in separate buildings, consult with CMS to

determine if the hospital is eligible for a single certificate.

The application must--

(1) Be made to HHS on a form or forms prescribed by HHS;

(2) Be signed by an owner or authorized representative of the laboratory who

attests that the laboratory will be operated in accordance with the

requirements established by the Secretary under section 353 of the Public

Health Service Act; and

(3) Describe the characteristics of the laboratory operation and the

examinations and other test procedures performed by the laboratory

including--

(i) The name and total number of tests and examinations performed

annually (excluding waived tests and tests for quality control, quality

assurance or proficiency testing purposes);

(ii)The methodologies for each laboratory test procedure or examination

performed, or both; and

(iii)The qualifications (educational background, training, and experience)

of the personnel directing and supervising the laboratory and

performing the laboratory examinations and test procedures.

(d) Access and reporting requirements.

All laboratories must make records available and submit reports to HHS as HHS

may reasonably require to determine compliance with this section.

§493.57 Requirements for a registration certificate

(Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)

A registration certificate is required for all laboratories seeking a certificate of

accreditation, unless the laboratory holds a valid certificate of compliance issued by

HHS.

Interpretive Guidelines §493.57

See section 6036 of the SOM for instructions on handling a laboratory operating without

a CLIA certificate.

§493.57(a) HHS will issue a registration certificate if the laboratory--

(1) Complies with the requirements of §493.55;

(2) Agrees to notify HHS within 30 days of any changes in ownership, name,

location, director, or supervisor (laboratories performing high complexity testing

only);

(3) Agrees to treat proficiency testing samples in the same manner as it treats

patient specimens; and

(4) Remits the fee for the registration certificate specified in subpart F of this part.

(b)(1) The laboratory must provide HHS with proof of accreditation by an approved

accreditation program--

(i) Within 11 months of issuance of the registration certificate; or

(ii) Prior to the expiration of the certificate of compliance.

(2) If such proof of accreditation is not supplied within this timeframe, the

laboratory must meet, or continue to meet, the requirements of §493.49.

revocation, or limitation of a laboratory’s registration certificate and will deny the

laboratory’s application for a certificate of accreditation for failure to comply with

the requirements set forth in this subpart. In addition, failure to meet the

requirements of this subpart will result in suspension or denial of payments under

Medicare and Medicaid as specified in subpart R of this part.

(d) A registration certificate is valid for a period of no more than 2 years. However,

it may be reissued if the laboratory is subject to subpart C of this part, as specified

in §493.57(b)(2) and compliance has not been determined by HHS before the

expiration date of the registration certificate.

(e) In the event that the laboratory does not meet the requirements of this subpart,

HHS will--

Interpretive Guidelines §493.57(c)-(e)

See the Appeals section of the SOM beginning at sections 6258 and 6300 for instructions

on denial of a certificate of accreditation application.

(1) Deny a laboratory’s request for certificate of accreditation;

(2) Notify the laboratory if it must meet the requirements for a certificate as defined

in subpart C of this part;

(3) Provide the laboratory with a statement of grounds on which the application

denial is based;

(4) Offer an opportunity for appeal on the application denial as provided in subpart

R of this part. If the laboratory requests a hearing within the time specified by HHS,

the laboratory will retain its registration certificate or reissued registration

certificate until a decision is made by an administrative law judge as provided in

subpart R, unless HHS finds that conditions at the laboratory pose an imminent and

serious risk to human health; and

(5) For those laboratories receiving payment from the Medicare or Medicaid

program, such payments will be suspended on the effective date specified in the

notice to the laboratory of denial of the request even if there has been no appeals

decision issued.

§493.61 Requirements for a certificate of accreditation

(Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)

(a) HHS will issue a certificate of accreditation to a laboratory if the laboratory--

(1) Meets the requirements of §493.57 or, if applicable, §493.49 of subpart C

of this part; and

(2) Remits the certificate of accreditation fee specified in subpart F of this

part.

(b) Laboratories issued a certificate of accreditation must--

(1) Treat proficiency testing samples in the same manner as patient samples;

(2) Meet the requirements of §493.63;

(3) Comply with the requirements of the approved accreditation program;

(4) Permit random sample validation and complaint inspections as required

in subpart Q of this part;

(5) Permit HHS to monitor the correction of any deficiencies found through

the inspections specified in paragraph (b)(4) of this section;

Interpretive Guidelines §493.61(b)(5)

See sections 6166 and 6184 of the SOM for procedures on follow-up of correction of

deficiencies cited during validation inspections.

(6) Authorize the accreditation program to release to HHS the laboratory’s

inspection findings whenever HHS conducts random sample or complaint

inspections; and

(7) Authorize its accreditation program to submit to HHS the results of the

laboratory’s proficiency testing.

(1) Will no longer meet the requirements of this part by virtue of its

accreditation in an approved accreditation program;

(2) Will be subject to full determination of compliance by HHS;

(3) May be subject to suspension, revocation or limitation of the laboratory’s

certificate of accreditation or certain alternative sanctions; and

(4) May be subject to suspension of payments under Medicare and Medicaid

as specified in subpart R.

(d) A certificate of accreditation issued under this subpart is valid for no more than

2 years. In the event of a non-compliance determination as a result of a random

sample validation or complaint inspection, a laboratory will be subject to a full

review by HHS in accordance with §488.11 of this chapter.

Interpretive Guidelines §493.61(d)

42 CFR §488.11 lists State survey agency functions.

(e) Failure to meet the applicable requirements of part 493, will result in an action

by HHS to suspend, revoke or limit the certificate of accreditation. HHS will--

(1) Provide the laboratory with a statement of grounds on which the

determination of noncompliance is based;

(2) Notify the laboratory if it is eligible to apply for a certificate as defined in

subpart C of this part; and

(3) Offer an opportunity for appeal as provided in subpart R of this part.

(f) If the laboratory requests a hearing within the time frame specified by HHS--

(1) It retains its certificate of accreditation or reissued certificate of

accreditation until a decision is made by an administrative law judge as

provided in subpart R of this part, unless HHS finds that conditions at the

laboratory pose an imminent and serious risk to human health; and

(2) For those laboratories receiving payments from the Medicare or

Medicaid program, such payments will be suspended on the effective date

specified in the notice to the laboratory even if there has been no appeals

decision issued.

(g) In the event the accreditation organization’s approval is removed by HHS, the

laboratory will be subject to the applicable requirements of subpart C of this part or

§493.57.

Interpretive Guidelines §493.61(g)

Accrediting organizations which lose deemed status are required to notify their

participating laboratories. These laboratories must re-apply for accreditation with

another CMS-approved accrediting organization or apply for the appropriate CLIA

certificate with CMS.

(h) A laboratory seeking to renew its certificate of accreditation must--

(1) Complete and return the renewal application to HHS 9 to 12 months

prior to the expiration of the certificate of accreditation;

(2) Meet the requirements of this subpart; and

(3) Submit the certificate of accreditation fee specified in subpart F of this

part.

(i) If HHS determines that the renewal application for a certificate of

accreditation is to be denied or limited, HHS will notify the laboratory

in writing of--

(1) The basis for denial of the application;

(2) Whether the laboratory is eligible for a certificate as defined in

subpart C of this part;

(3) The opportunity for appeal on HHS’s action to deny the renewal

application for certificate of accreditation as provided in subpart R of

this part. If the laboratory requests a hearing within the time frame

specified by HHS, it retains its certificate of accreditation or reissued

certificate of accreditation until a decision is made by an

administrative law judge as provided in subpart R of this part, unless

HHS finds that conditions at the laboratory pose an imminent and

serious risk to human health; and

(4) Suspension of payments under Medicare or Medicaid for those laboratories

receiving payments under the Medicare or Medicaid programs.

§493.63 Notification requirements for laboratories issued a certificate of

accreditation

(Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)

Laboratories issued a certificate of accreditation must:

(a) Notify HHS and the approved accreditation program within 30 days of any

changes in--

(1) Ownership;

(2) Name;

(3) Location; or

(4) Director.

(b) Notify the approved accreditation program no later than 6 months after

performing any test or examination within a specialty or subspecialty area that is

not included in the laboratory’s accreditation, so that the accreditation organization

can determine compliance and a new certificate of accreditation can be issued.

changes in test methodologies for any test or examination included in a specialty or

subspecialty, or both, for which the laboratory has been issued a certificate of

accreditation.

Interpretive Guidelines §493.63(a)-(c)

See the section of the SOM beginning at section 6016 for handling changes in ownership,

name, location, personnel and test methodology, or additions or deletions of specialties or

subspecialties that may result in changes in complexity levels for the laboratory.

See the SOM beginning at section 6260 for instructions on handling laboratories that are

going out of business or voluntarily withdrawing from all testing, including laboratories

that are taking these actions while an enforcement action is pending.

Because there is no D-tag assigned to this regulation, you may use D0000 to cite noncompliance with this requirement.

Subpart H--Participation in Proficiency Testing for

Laboratories Performing Nonwaived Testing

Subpart H – General Guidelines

(Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)

By law, proficiency testing (PT) programs are evaluated initially for CMS approval and

annually thereafter for re-approval. After review, CMS will issue PT program approvals

and/or re-approvals provided they meet the requirements of Subpart I, Proficiency

Testing Programs for Nonwaived Testing. A listing of these programs with the

specialties, subspecialties, and specific analytes for which they are approved is available

on the CMS CLIA web site at

https://www.cms.gov/medicare/quality/clinical-laboratory-

improvement-amendments/proficiency-testing.

A CMS-approved PT program has been evaluated and found to be in compliance with the

requirements of Subpart I and the applicable sections of Subpart H. When a laboratory

experiences problems with PT samples, it resolves them with the PT program. When the

SA experiences problems with an approved program, report all available information to

CMS. CMS renders a decision on the termination or continued approval of the PT

program, as appropriate. The Centers for Disease Control and Prevention may be

requested by CMS to provide technical advice.

History

Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25

Provenance

Source: cms.gov
Retrieved: 2026-07-22
Edition: som-2026-07-22
Content hash: 5ced1960259bfac5f37790d885ecd8169dc310822c045b136499b7bb70e66740

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