D.17 42 CFR Part 493-Laboratory Requirements 02.pdf
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- 36C25923R0040
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This document outlines requirements for laboratory testing services. The Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 19 is seeking a contractor to provide testing at the McCurtain CBOC in accordance with Clinical Laboratory Improvement Amendments regulations. Services must include waived, moderately complex, and highly complex testing categorized by specialty and subspecialty. The contractor must meet personnel, quality control, proficiency testing, facility administration, and other standards. The period of performance and response deadline are not specified.
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Title 42 - Public Health Chapter IV - Centers for Medicare & Medicaid Services, Department of Health and Human
Services Subchapter G - Standards and Certification
Part 493 Laboratory Requirements Subpart A General Provisions
§ 493.1 Basis and scope.
§ 493.2 Definitions.
§ 493.3 Applicability.
§ 493.5 Categories of tests by complexity.
§ 493.15 Laboratories performing waived tests.
§ 493.17 Test categorization.
§ 493.19 Provider-performed microscopy (PPM) procedures.
§ 493.20 Laboratories performing tests of moderate complexity.
§ 493.25 Laboratories performing tests of high complexity.
Subpart B Certificate of Waiver § 493.35 Application for a certificate of waiver.
§ 493.37 Requirements for a certificate of waiver.
§ 493.39 Notification requirements for laboratories issued a certificate of waiver.
§ 493.41 Condition: Reporting of SARS-CoV-2 test results.
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.
§ 493.45 Requirements for a registration certificate.
§ 493.47 Requirements for a certificate for provider-performed microscopy (PPM) procedures.
§ 493.49 Requirements for a certificate of compliance.
§ 493.51 Notification requirements for laboratories issued a certificate of compliance.
§ 493.53 Notification requirements for laboratories issued a certificate for provider-performed microscopy (PPM) procedures.
Subpart D Certificate of Accreditation
§ 493.55 Application for registration certificate and certificate of accreditation.
§ 493.57 Requirements for a registration certificate.
§ 493.61 Requirements for a certificate of accreditation.
§ 493.63 Notification requirements for laboratories issued a certificate of accreditation.
This content is from the eCFR and is authoritative but unofficial.
42 CFR Part 493
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D.17 42CFR PART 493 LABORATORY REQUIREMENTS
36C25923R0040
42 RFR PART 493
(up to date as of 8/19/2022) Laboratory Requirements
Subpart E Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program
§ 493.551 General requirements for laboratories.
§ 493.553 Approval process (application and reapplication) for accreditation organizations and
State licensure programs.
§ 493.555 Federal review of laboratory requirements.
§ 493.557 Additional submission requirements.
§ 493.559 Publication of approval of deeming authority or CLIA exemption.
§ 493.561 Denial of application or reapplication.
§ 493.563 Validation inspections - Basis and focus.
§ 493.565 Selection for validation inspection - laboratory responsibilities.
§ 493.567 Refusal to cooperate with validation inspection.
§ 493.569 Consequences of a finding of noncompliance as a result of a validation inspection.
§ 493.571 Disclosure of accreditation, State and CMS validation inspection results.
§ 493.573 Continuing Federal oversight of private nonprofit accreditation organizations and approved State licensure programs.
§ 493.575 Removal of deeming authority or CLIA exemption and final determination review.
Subpart F General Administration § 493.602 Scope of subpart.
§ 493.606 Applicability of subpart.
§ 493.638 Certificate fees.
§ 493.639 Fee for revised certificate.
§ 493.643 Fee for determination of program compliance.
§ 493.645 Additional fee(s) applicable to approved State laboratory programs and laboratories issued a certificate of accreditation, certificate of waiver, or certificate for PPM procedures.
§ 493.646 Payment of fees.
§ 493.649 Methodology for determining fee amount.
Subpart G [Reserved] Subpart H Participation in Proficiency Testing for Laboratories Performing
Nonwaived Testing § 493.801 Condition: Enrollment and testing of samples.
§ 493.803 Condition: Successful participation.
§ 493.807 Condition: Reinstatement of laboratories performing nonwaived testing.
Proficiency Testing by Specialty and Subspecialty for Laboratories Performing Tests of Moderate Complexity (Including the Subcategory), High Complexity, or Any Combination of These Tests
§ 493.821 Condition: Microbiology.
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§ 493.823 Standard; Bacteriology.
§ 493.825 Standard; Mycobacteriology.
§ 493.827 Standard; Mycology.
§ 493.829 Standard; Parasitology.
§ 493.831 Standard; Virology.
§ 493.833 Condition: Diagnostic immunology.
§ 493.835 Standard; Syphilis serology.
§ 493.837 Standard; General immunology.
§ 493.839 Condition: Chemistry.
§ 493.841 Standard; Routine chemistry.
§ 493.843 Standard; Endocrinology.
§ 493.845 Standard; Toxicology.
§ 493.849 Condition: Hematology.
§ 493.851 Standard; Hematology.
§ 493.853 Condition: Pathology.
§ 493.855 Standard; Cytology: gynecologic examinations.
§ 493.857 Condition: Immunohematology.
§ 493.859 Standard; ABO group and D (Rho) typing.
§ 493.861 Standard; Unexpected antibody detection.
§ 493.863 Standard; Compatibility testing.
§ 493.865 Standard; Antibody identification.
Subpart I Proficiency Testing Programs for Nonwaived Testing § 493.901 Approval of proficiency testing programs.
§ 493.903 Administrative responsibilities.
§ 493.905 Nonapproved proficiency testing programs.
Proficiency Testing Programs by Specialty and Subspecialty
§ 493.909 Microbiology.
§ 493.911 Bacteriology.
§ 493.913 Mycobacteriology.
§ 493.915 Mycology.
§ 493.917 Parasitology.
§ 493.919 Virology.
§ 493.921 Diagnostic immunology.
§ 493.923 Syphilis serology.
§ 493.927 General immunology.
§ 493.929 Chemistry.
§ 493.931 Routine chemistry.
§ 493.933 Endocrinology.
§ 493.937 Toxicology.
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§ 493.941 Hematology (including routine hematology and coagulation).
§ 493.945 Cytology; gynecologic examinations.
§ 493.959 Immunohematology.
Subpart J Facility Administration for Nonwaived Testing § 493.1100 Condition: Facility administration.
§ 493.1101 Standard: Facilities.
§ 493.1103 Standard: Requirements for transfusion services.
§ 493.1105 Standard: Retention requirements.
Subpart K Quality System for Nonwaived Testing § 493.1200 Introduction.
§ 493.1201 Condition: Bacteriology.
§ 493.1202 Condition: Mycobacteriology.
§ 493.1203 Condition: Mycology.
§ 493.1204 Condition: Parasitology.
§ 493.1205 Condition: Virology.
§ 493.1207 Condition: Syphilis serology.
§ 493.1208 Condition: General immunology.
§ 493.1210 Condition: Routine chemistry.
§ 493.1211 Condition: Urinalysis.
§ 493.1212 Condition: Endocrinology.
§ 493.1213 Condition: Toxicology.
§ 493.1215 Condition: Hematology.
§ 493.1217 Condition: Immunohematology.
§ 493.1219 Condition: Histopathology.
§ 493.1220 Condition: Oral pathology.
§ 493.1221 Condition: Cytology.
§ 493.1225 Condition: Clinical cytogenetics.
§ 493.1226 Condition: Radiobioassay.
§ 493.1227 Condition: Histocompatibility.
General Laboratory Systems
§ 493.1230 Condition: General laboratory systems.
§ 493.1231 Standard: Confidentiality of patient information.
§ 493.1232 Standard: Specimen identification and integrity.
§ 493.1233 Standard: Complaint investigations.
§ 493.1234 Standard: Communications.
§ 493.1235 Standard: Personnel competency assessment policies.
§ 493.1236 Standard: Evaluation of proficiency testing performance.
§ 493.1239 Standard: General laboratory systems quality assessment.
Preanalytic Systems
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§ 493.1240 Condition: Preanalytic systems.
§ 493.1241 Standard: Test request.
§ 493.1242 Standard: Specimen submission, handling, and referral.
§ 493.1249 Standard: Preanalytic systems quality assessment.
Analytic Systems § 493.1250 Condition: Analytic systems.
§ 493.1251 Standard: Procedure manual.
§ 493.1252 Standard: Test systems, equipment, instruments, reagents, materials, and supplies.
§ 493.1253 Standard: Establishment and verification of performance specifications.
§ 493.1254 Standard: Maintenance and function checks.
§ 493.1255 Standard: Calibration and calibration verification procedures.
§ 493.1256 Standard: Control procedures.
§ 493.1261 Standard: Bacteriology.
§ 493.1262 Standard: Mycobacteriology.
§ 493.1263 Standard: Mycology.
§ 493.1264 Standard: Parasitology.
§ 493.1265 Standard: Virology.
§ 493.1267 Standard: Routine chemistry.
§ 493.1269 Standard: Hematology.
§ 493.1271 Standard: Immunohematology.
§ 493.1273 Standard: Histopathology.
§ 493.1274 Standard: Cytology.
§ 493.1276 Standard: Clinical cytogenetics.
§ 493.1278 Standard: Histocompatibility.
§ 493.1281 Standard: Comparison of test results.
§ 493.1282 Standard: Corrective actions.
§ 493.1283 Standard: Test records.
§ 493.1289 Standard: Analytic systems quality assessment.
Postanalytic Systems § 493.1290 Condition: Postanalytic systems.
§ 493.1291 Standard: Test report.
§ 493.1299 Standard: Postanalytic systems quality assessment.
Subpart L [Reserved] Subpart M Personnel for Nonwaived Testing
§ 493.1351 General.
Laboratories Performing Provider-Performed Microscopy (PPM) Procedures
§ 493.1353 Scope.
§ 493.1355 Condition: Laboratories performing PPM procedures; laboratory director.
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§ 493.1357 Standard; laboratory director qualifications.
§ 493.1359 Standard; PPM laboratory director responsibilities.
§ 493.1361 Condition: Laboratories performing PPM procedures; testing personnel.
§ 493.1363 Standard: PPM testing personnel qualifications.
§ 493.1365 Standard; PPM testing personnel responsibilities.
Laboratories Performing Moderate Complexity Testing § 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director.
§ 493.1405 Standard; Laboratory director qualifications.
§ 493.1406 Standard; Laboratory director qualifications on or before February 28, 1992.
§ 493.1407 Standard; Laboratory director responsibilities.
§ 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant.
§ 493.1411 Standard; Technical consultant qualifications.
§ 493.1413 Standard; Technical consultant responsibilities.
§ 493.1415 Condition: Laboratories performing moderate complexity testing; clinical consultant.
§ 493.1417 Standard; Clinical consultant qualifications.
§ 493.1419 Standard; Clinical consultant responsibilities.
§ 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel.
§ 493.1423 Standard; Testing personnel qualifications.
§ 493.1425 Standard; Testing personnel responsibilities.
Laboratories Performing High Complexity Testing § 493.1441 Condition: Laboratories performing high complexity testing; laboratory director.
§ 493.1443 Standard; Laboratory director qualifications.
§ 493.1445 Standard; Laboratory director responsibilities.
§ 493.1447 Condition: Laboratories performing high complexity testing; technical supervisor.
§ 493.1449 Standard; Technical supervisor qualifications.
§ 493.1451 Standard: Technical supervisor responsibilities.
§ 493.1453 Condition: Laboratories performing high complexity testing; clinical consultant.
§ 493.1455 Standard; Clinical consultant qualifications.
§ 493.1457 Standard; Clinical consultant responsibilities.
§ 493.1459 Condition: Laboratories performing high complexity testing; general supervisor.
§ 493.1461 Standard: General supervisor qualifications.
§ 493.1462 General supervisor qualifications on or before February 28, 1992.
§ 493.1463 Standard: General supervisor responsibilities.
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§ 493.1467 Condition: Laboratories performing high complexity testing; cytology general supervisor.
§ 493.1469 Standard: Cytology general supervisor qualifications.
§ 493.1471 Standard: Cytology general supervisor responsibilities.
§ 493.1481 Condition: Laboratories performing high complexity testing; cytotechnologist.
§ 493.1483 Standard: Cytotechnologist qualifications.
§ 493.1485 Standard; Cytotechnologist responsibilities.
§ 493.1487 Condition: Laboratories performing high complexity testing; testing personnel.
§ 493.1489 Standard; Testing personnel qualifications.
§ 493.1491 Technologist qualifications on or before February 28, 1992.
§ 493.1495 Standard; Testing personnel responsibilities.
Subparts N-P [Reserved] Subpart Q Inspection
§ 493.1771 Condition: Inspection requirements applicable to all CLIA-certified and CLIA-exempt laboratories.
§ 493.1773 Standard: Basic inspection requirements for all laboratories issued a CLIA certificate and CLIA-exempt laboratories.
§ 493.1775 Standard: Inspection of laboratories issued a certificate of waiver or a certificate for provider-performed microscopy procedures.
§ 493.1777 Standard: Inspection of laboratories that have requested or have been issued a certificate of compliance.
§ 493.1780 Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a certificate of accreditation.
Subpart R Enforcement Procedures § 493.1800 Basis and scope.
§ 493.1804 General considerations.
§ 493.1806 Available sanctions: All laboratories.
§ 493.1807 Additional sanctions: Laboratories that participate in Medicare.
§ 493.1808 Adverse action on any type of CLIA certificate: Effect on Medicare approval.
§ 493.1809 Limitation on Medicaid payment.
§ 493.1810 Imposition and lifting of alternative sanctions.
§ 493.1812 Action when deficiencies pose immediate jeopardy.
§ 493.1814 Action when deficiencies are at the condition level but do not pose immediate jeopardy.
§ 493.1816 Action when deficiencies are not at the condition level.
§ 493.1820 Ensuring timely correction of deficiencies.
§ 493.1826 Suspension of part of Medicare payments.
§ 493.1828 Suspension of all Medicare payments.
§ 493.1832 Directed plan of correction and directed portion of a plan of correction.
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§ 493.1834 Civil money penalty.
§ 493.1836 State onsite monitoring.
§ 493.1838 Training and technical assistance for unsuccessful participation in proficiency testing.
§ 493.1840 Suspension, limitation, or revocation of any type of CLIA certificate.
§ 493.1842 Cancellation of Medicare approval.
§ 493.1844 Appeals procedures.
§ 493.1846 Civil action.
§ 493.1850 Laboratory registry.
Subpart S [Reserved] Subpart T Consultations
§ 493.2001 Establishment and function of the Clinical Laboratory Improvement Advisory Committee.
PART 493 - LABORATORY REQUIREMENTS
Authority: 42 U.S.C. 263a, 1302, 1395x(e), the sentence following 1395x(s)(11) through 1395x(s)(16).
Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.
Subpart A - General Provisions
Source: 57 FR 7139, Feb. 28, 1992, unless otherwise noted.
§ 493.1 Basis and scope.
This part sets forth the conditions that all laboratories must meet to be certified to perform testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). It implements sections 1861(e) and (j), the sentence following section 1861(s)(13), and 1902(a)(9) of the Social Security Act, and section 353 of the Public Health Service Act, as amended by section 2 of the Taking Essential Steps for Testing Act of 2012. This part applies to all laboratories as defined under “laboratory” in § 493.2 of this part. This part also applies to laboratories seeking payment under the Medicare and Medicaid programs. The requirements are the same for Medicare approval as for CLIA certification.
[57 FR 7139, Feb. 28, 1992, as amended at 79 FR 25480, May 2, 2014]
§ 493.2 Definitions.
As used in this part, unless the context indicates otherwise -
Accredited institution means a school or program which -
Link to an amendment published at 87 FR 41232, July 11, 2022.
42 CFR Part 493 (up to date as of 8/19/2022) Laboratory Requirements 42 CFR Part 493
42 CFR 493.2 “Accredited institution” (enhanced display) page 8 of 180 https://www.govinfo.gov/link/uscode/42/263a https://www.govinfo.gov/link/uscode/42/1302 https://www.govinfo.gov/link/uscode/42/1395x https://www.federalregister.gov/citation/55-FR-9576 https://www.federalregister.gov/citation/57-FR-7139 https://www.ecfr.gov/current/title-42/part-493/section-493.2/ https://www.federalregister.gov/citation/57-FR-7139 https://www.federalregister.gov/citation/79-FR-25480 https://www.federalregister.gov/citation/87-FR-41232
(a) Admits as regular student only persons having a certificate of graduation from a school providing secondary education, or the recognized equivalent of such certificate;
(b) Is legally authorized within the State to provide a program of education beyond secondary education;
(c) Provides an educational program for which it awards a bachelor's degree or provides not less than a 2-year program which is acceptable toward such a degree, or provides an educational program for which it awards a master's or doctoral degree;
(d) Is accredited by a nationally recognized accrediting agency or association.
This definition includes any foreign institution of higher education that HHS or its designee determines meets substantially equivalent requirements.
Accredited laboratory means a laboratory that has voluntarily applied for and been accredited by a private, nonprofit accreditation organization approved by CMS in accordance with this part;
Adverse action means the imposition of a principal or alternative sanction by CMS.
ALJ stands for Administrative Law Judge.
Alternative sanctions means sanctions that may be imposed in lieu of or in addition to principal sanctions. The term is synonymous with “intermediate sanctions” as used in section 1846 of the Act.
Analyte means a substance or constituent for which the laboratory conducts testing.
Approved accreditation organization for laboratories means a private, nonprofit accreditation organization that has formally applied for and received CMS's approval based on the organization's compliance with this part.
Approved State laboratory program means a licensure or other regulatory program for laboratories in a State, the requirements of which are imposed under State law, and the State laboratory program has received CMS approval based on the State's compliance with this part.
Authorized person means an individual authorized under State law to order tests or receive test results, or both.
Calibration means a process of testing and adjusting an instrument or test system to establish a correlation between the measurement response and the concentration or amount of the substance that is being measured by the test procedure.
Calibration verification means the assaying of materials of known concentration in the same manner as patient samples to substantiate the instrument or test system's calibration throughout the reportable range for patient test results.
Challenge means, for quantitative tests, an assessment of the amount of substance or analyte present or measured in a sample. For qualitative tests, a challenge means the determination of the presence or the absence of an analyte, organism, or substance in a sample.
CLIA means the Clinical Laboratory Improvement Amendments of 1988.
CLIA certificate means any of the following types of certificates issued by CMS or its agent:
(1) Certificate of compliance means a certificate issued to a laboratory after an inspection that finds the laboratory to be in compliance with all applicable condition level requirements, or reissued before the expiration date, pending an appeal, in accordance with § 493.49, when an inspection has found the laboratory to be out of compliance with one or more condition level requirements.
42 CFR Part 493 (up to date as of 8/19/2022) Laboratory Requirements 42 CFR 493.2 “Accredited institution” (a)
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(2) Certificate for provider-performed microscopy (PPM) procedures means a certificate issued or reissued before the expiration date, pending an appeal, in accordance with § 493.47, to a laboratory in which a physician, midlevel practitioner or dentist performs no tests other than PPM procedures and, if desired, waived tests listed in § 493.15(c).
(3) Certificate of accreditation means a certificate issued on the basis of the laboratory's accreditation by an accreditation organization approved by CMS (indicating that the laboratory is deemed to meet applicable CLIA requirements) or reissued before the expiration date, pending an appeal, in accordance with § 493.61, when a validation or complaint survey has found the laboratory to be noncompliant with one or more CLIA conditions.
(4) Certificate of registration or registration certificate means a certificate issued or reissued before the expiration date, pending an appeal, in accordance with § 493.45, that enables the entity to conduct moderate or high complexity laboratory testing or both until the entity is determined to be in compliance through a survey by CMS or its agent; or in accordance with § 493.57 to an entity that is accredited by an approved accreditation organization.
(5) Certificate of waiver means a certificate issued or reissued before the expiration date, pending an appeal, in accordance with § 493.37, to a laboratory to perform only the waived tests listed at § 493.15(c).
CLIA-exempt laboratory means a laboratory that has been licensed or approved by a State where CMS has determined that the State has enacted laws relating to laboratory requirements that are equal to or more stringent than CLIA requirements and the State licensure program has been approved by CMS in accordance with subpart E of this part.
Condition level deficiency means noncompliance with one or more condition level requirements.
Condition level requirements means any of the requirements identified as “conditions” in § 493.41 and subparts G through Q of this part.
Confirmatory testing means testing performed by a second analytical procedure that could be used to substantiate or bring into question the result of an initial laboratory test.
Credible allegation of compliance means a statement or documentation that -
(1) Is made by a representative of a laboratory that has a history of having maintained a commitment to compliance and of taking corrective action when required;
(2) Is realistic in terms of its being possible to accomplish the required corrective action between the date of the exit conference and the date of the allegation; and
(3) Indicates that the problem has been resolved.
Dentist means a doctor of dental medicine or doctor of dental surgery licensed by the State to practice dentistry within the State in which the laboratory is located.
Distributive testing means laboratory testing performed on the same specimen, or an aliquot of it, that requires sharing it between two or more laboratories to obtain all data required to complete an interpretation or calculation necessary to provide a final reportable result for the originally ordered test. When such testing occurs at multiple locations with different CLIA certificates, it is considered distributive testing.
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Equivalency means that an accreditation organization's or a State laboratory program's requirements, taken as a whole, are equal to or more stringent than the CLIA requirements established by CMS, taken as whole. It is acceptable for an accreditation organization's or State laboratory program's requirements to be organized differently or otherwise vary from the CLIA requirements, as long as
(1) all of the requirements taken as a whole would provide at least the same protection as the CLIA requirements taken as a whole; and
(2) a finding of noncompliance with respect to CLIA requirements taken as a whole would be matched by a finding of noncompliance with the accreditation or State requirements taken as a whole.
CMS agent means an entity with which CMS arranges to inspect laboratories and assess laboratory activities against CLIA requirements and may be a State survey agency, a private, nonprofit organization other than an approved accreditation organization, a component of HHS, or any other governmental component CMS approves for this purpose. In those instances where all of the laboratories in a State are exempt from CLIA requirements, based on the approval of a State's exemption request, the State survey agency is not the CMS agent.
FDA-cleared or approved test system means a test system cleared or approved by the FDA through the premarket notification (510(k)) or premarket approval (PMA) process for in-vitro diagnostic use. Unless otherwise stated, this includes test systems exempt from FDA premarket clearance or approval.
HHS means the Department of Health and Human Services, or its designee.
Immediate jeopardy means a situation in which immediate corrective action is necessary because the laboratory's noncompliance with one or more condition level requirements has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the laboratory or to the health or safety of the general public. This term is synonymous with imminent and serious risk to human health and significant hazard to the public health.
Intentional violation means knowing and willful noncompliance with any CLIA condition.
Kit means all components of a test that are packaged together.
Laboratory means a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body 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, human beings. These examinations also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body. Facilities only collecting or preparing specimens (or both) or only serving as a mailing service and not performing testing are not considered laboratories.
Midlevel practitioner means a nurse midwife, nurse practitioner, or physician assistant, licensed by the State within which the individual practices, if such licensing is required in the State in which the laboratory is located.
Nonwaived test means any test system, assay, or examination that has not been found to meet the statutory criteria specified at section 353(d)(3) of the Public Health Service Act.
Operator means the individual or group of individuals who oversee all facets of the operation of a laboratory and who bear primary responsibility for the safety and reliability of the results of all specimen testing performed in that laboratory. The term includes -
(1) A director of the laboratory if he or she meets the stated criteria; and
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Example: Assume the State survey agency, CMS or other CMS agent performs 200 sample validation inspections for laboratories accredited by a single accreditation organization or licensed in an exempt State during a validation review period and finds that 60 of the 200 laboratories had one or more condition level requirements out of compliance. CMS reviews the validation and accreditation organization's or State's inspections of the validated laboratories and determines that the State or accreditation organization found comparable deficiencies in 22 of the 60 laboratories and it is reasonable to conclude that deficiencies were present in the remaining 38 laboratories at the time of the accreditation organization's or State's inspection. Thirty-eight divided by 200 equals a 19 percent rate of disparity.
(2) The members of the board of directors and the officers of a laboratory that is a small corporation under subchapter S of the Internal Revenue Code.
Owner means any person who owns any interest in a laboratory except for an interest in a laboratory whose stock and/or securities are publicly traded. (That is e.g., the purchase of shares of stock or securities on the New York Stock Exchange in a corporation owning a laboratory would not make a person an owner for the purpose of this regulation.)
Party means a laboratory affected by any of the enforcement procedures set forth in this subpart, by CMS or the OIG, as appropriate.
Performance characteristic means a property of a test that is used to describe its quality, e.g., accuracy, precision, analytical sensitivity, analytical specificity, reportable range, reference range, etc.
Performance specification means a value or range of values for a performance characteristic, established or verified by the laboratory, that is used to describe the quality of patient test results.
Physician means an individual with a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine degree who is licensed by the State to practice medicine, osteopathy, or podiatry within the State in which the laboratory is located.
Principal sanction means the suspension, limitation, or revocation of any type of CLIA certificate or the cancellation of the laboratory's approval to receive Medicare payment for its services.
Prospective laboratory means a laboratory that is operating under a registration certificate or is seeking any of the three other types of CLIA certificates.
Rate of disparity means the percentage of sample validation inspections for a specific accreditation organization or State where CMS, the State survey agency or other CMS agent finds noncompliance with one or more condition level requirements but no comparable deficiencies were cited by the accreditation organization or the State, and it is reasonable to conclude that the deficiencies were present at the time of the most recent accreditation organization or State licensure inspection.
Referee laboratory means a laboratory currently in compliance with applicable CLIA requirements, that has had a record of satisfactory proficiency testing performance for all testing events for at least one year for a specific test, analyte, subspecialty, or specialty and has been designated by an HHS approved proficiency testing program as a referee laboratory for analyzing proficiency testing specimens for the purpose of determining the correct response for the specimens in a testing event for that specific test, analyte, subspecialty, or specialty.
42 CFR Part 493 (up to date as of 8/19/2022) Laboratory Requirements 42 CFR 493.2 “Operator” (2)
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Reference range means the range of test values expected for a designated population of individuals, e.g., 95 percent of individuals that are presumed to be healthy (or normal).
Reflex testing means confirmatory or additional laboratory testing that is automatically requested by a laboratory under its standard operating procedures for patient specimens when the laboratory's findings indicate test results that are abnormal, are outside a predetermined range, or meet other pre-established criteria for additional testing.
Repeat proficiency testing referral means a second instance in which a proficiency testing sample, or a portion of a sample, is referred, for any reason, to another laboratory for analysis prior to the laboratory's proficiency testing program event cut-off date within the period of time encompassing the two prior survey cycles (including initial certification, recertification, or the equivalent for laboratories surveyed by an approved accreditation organization).
Reportable range means the span of test result values over which the laboratory can establish or verify the accuracy of the instrument or test system measurement response.
Sample in proficiency testing means the material contained in a vial, on a slide, or other unit that contains material to be tested by proficiency testing program participants. When possible, samples are of human origin.
State includes, for purposes of this part, each of the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands and a political subdivision of a State where the State, acting pursuant to State law, has expressly delegated powers to the political subdivision sufficient to authorize the political subdivision to act for the State in enforcing requirements equal to or more stringent than CLIA requirements.
State licensure means the issuance of a license to, or the approval of, a laboratory by a State laboratory program as meeting standards for licensing or approval established under State law.
State licensure program means a State laboratory licensure or approval program.
State survey agency means the State health agency or other appropriate State or local agency that has an agreement under section 1864 of the Social Security Act and is used by CMS to perform surveys and inspections.
Substantial allegation of noncompliance means a complaint from any of a variety of sources (including complaints submitted in person, by telephone, through written correspondence, or in newspaper or magazine articles) that, if substantiated, would have an impact on the health and safety of the general public or of individuals served by a laboratory and raises doubts as to a laboratory's compliance with any condition level requirement.
Target value for quantitative tests means either the mean of all participant responses after removal of outliers (those responses greater than 3 standard deviations from the original mean) or the mean established by definitive or reference methods acceptable for use in the National Reference System for the Clinical Laboratory (NRSCL) by the National Committee for the Clinical Laboratory Standards (NCCLS). In instances where definitive or reference methods are not available or a specific method's results demonstrate bias that is not observed with actual patient specimens, as determined by a defensible scientific protocol, a comparative method or a method group (“peer” group) may be used. If the method group is less than 10 participants, “target value” means the overall mean after outlier removal (as defined above) unless acceptable scientific reasons are available to indicate that such an evaluation is not appropriate.
42 CFR Part 493 (up to date as of 8/19/2022) Laboratory Requirements 42 CFR 493.2 “Reference range”
42 CFR 493.2 “Target value” (enhanced display) page 13 of 180
[57 FR 7139, Feb. 28, 1992, as amended at 57 FR 7236, Feb. 28, 1992; 57 FR 34013, July 31, 1992; 57 FR 35761, Aug. 11, 1992; 58 FR 5220, Jan. 19, 1993; 58 FR 48323, Sept. 15, 1993; 60 FR 20043, Apr. 24, 1995; 63 FR 26732, May 14, 1998; 68 FR 3702, Jan. 24, 2003; 68 FR 50723, Aug. 22, 2003; 79 FR 25480, May 2, 2014; 79 FR 27157, May 12, 2014; 85 FR 54873, Sept. 2, 2020]
§ 493.3 Applicability.
Test system means the instructions and all of the instrumentation, equipment, reagents, and supplies needed to perform an assay or examination and generate test results.
Unsatisfactory proficiency testing performance means failure to attain the minimum satisfactory score for an analyte, test, subspecialty, or specialty for a testing event.
Unsuccessful participation in proficiency testing means any of the following:
(1) Unsatisfactory performance for the same analyte in two consecutive or two out of three testing events.
(2) Repeated unsatisfactory overall testing event scores for two consecutive or two out of three testing events for the same specialty or subspecialty.
(3) An unsatisfactory testing event score for those subspecialties not graded by analyte (that is, bacteriology, mycobacteriology, virology, parasitology, mycology, blood compatibility, immunohematology, or syphilis serology) for the same subspecialty for two consecutive or two out of three testing events.
(4) Failure of a laboratory performing gynecologic cytology to meet the standard at § 493.855.
Unsuccessful proficiency testing performance means a failure to attain the minimum satisfactory score for an analyte, test, subspecialty, or specialty for two consecutive or two of three consecutive testing events.
Validation review period means the one year time period during which CMS conducts validation inspections and evaluates the results of the most recent surveys performed by an accreditation organization or State laboratory program.
Waived test means a test system, assay, or examination that HHS has determined meets the CLIA statutory criteria as specified for waiver under section 353(d)(3) of the Public Health Service Act.
(a) Basic rule. Except as specified in paragraph (b) of this section, a laboratory will be cited as out of compliance with section 353 of the Public Health Service Act unless it -
(1) Has a current, unrevoked or unsuspended certificate of waiver, registration certificate, certificate of compliance, certificate for PPM procedures, or certificate of accreditation issued by HHS applicable to the category of examinations or procedures performed by the laboratory; or
(2) Is CLIA-exempt.
(b) Exception. These rules do not apply to components or functions of -
(1) Any facility or component of a facility that only performs testing for forensic purposes;
(2) Research laboratories that test human specimens but do not report patient specific results for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of individual patients; or
42 CFR Part 493 (up to date as of 8/19/2022) Laboratory Requirements 42 CFR 493.2 “Test system”
42 CFR 493.3(b)(2) (enhanced display) page 14 of 180 https://www.federalregister.gov/citation/57-FR-7139 https://www.federalregister.gov/citation/57-FR-7236 https://www.federalregister.gov/citation/57-FR-34013 https://www.federalregister.gov/citation/57-FR-35761 https://www.federalregister.gov/citation/58-FR-5220 https://www.federalregister.gov/citation/58-FR-5220 https://www.federalregister.gov/citation/58-FR-48323 https://www.federalregister.gov/citation/60-FR-20043 https://www.federalregister.gov/citation/63-FR-26732 https://www.federalregister.gov/citation/68-FR-3702 https://www.federalregister.gov/citation/68-FR-50723 https://www.federalregister.gov/citation/79-FR-25480 https://www.federalregister.gov/citation/79-FR-27157 https://www.federalregister.gov/citation/85-FR-54873
[57 FR 7139, Feb. 28, 1992, as amended at 58 FR 5221, Jan. 19, 1993; 60 FR 20043, Apr. 24, 1995; 68 FR 3702, Jan. 24, 2003]
§ 493.5 Categories of tests by complexity.
[60 FR 20043, Apr. 24, 1995]
§ 493.15 Laboratories performing waived tests.
(3) Laboratories certified by the Substance Abuse and Mental Health Services Administration (SAMHSA), in which drug testing is performed which meets SAMHSA guidelines and regulations.
However, all other testing conducted by a SAMHSA-certified laboratory is subject to this rule.
(c) Federal laboratories. Laboratories under the jurisdiction of an agency of the Federal Government are subject to the rules of this part, except that the Secretary may modify the application of such requirements as appropriate.
(a) Laboratory tests are categorized as one of the following:
(1) Waived tests.
(2) Tests of moderate complexity, including the subcategory of PPM procedures.
(3) Tests of high complexity.
(b) A laboratory may perform only waived tests, only tests of moderate complexity, only PPM procedures, only tests of high complexity or any combination of these tests.
(c) Each laboratory must be either CLIA-exempt or possess one of the following CLIA certificates, as defined in § 493.2:
(1) Certificate of registration or registration certificate.
(2) Certificate of waiver.
(3) Certificate for PPM procedures.
(4) Certificate of compliance.
(5) Certificate of accreditation.
(a) Requirement. Tests for certificate of waiver must meet the descriptive criteria specified in paragraph (b) of this section.
(b) Criteria. Test systems are simple laboratory examinations and procedures which -
(1) Are cleared by FDA for home use;
(2) Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or
(3) Pose no reasonable risk of harm to the patient if the test is performed incorrectly.
(c) Certificate of waiver tests. A laboratory may qualify for a certificate of waiver under section 353 of the PHS Act if it restricts the tests that it performs to one or more of the following tests or examinations (or additional tests added to this list as provided under paragraph (d) of this section) and no others:
(1) Dipstick or Tablet Reagent Urinalysis (non-automated) for the following:
42 CFR Part 493 (up to date as of 8/19/2022) Laboratory Requirements 42 CFR 493.3(b)(3)
42 CFR 493.15(c)(1) (enhanced display) page 15 of 180 https://www.federalregister.gov/citation/57-FR-7139 https://www.federalregister.gov/citation/58-FR-5221 https://www.federalregister.gov/citation/60-FR-20043 https://www.federalregister.gov/citation/68-FR-3702 https://www.federalregister.gov/citation/60-FR-20043
[57 FR 7139, Feb. 28, 1992, as amended at 58 FR 5221, Jan. 19, 1993; 82 FR 48773, Oct. 20, 2017]
§ 493.17 Test categorization.
(i) Bilirubin;
(ii) Glucose;
(iii) Hemoglobin;
(iv) Ketone;
(v) Leukocytes;
(vi) Nitrite;
(vii) pH;
(viii) Protein;
(ix) Specific gravity; and
(x) Urobilinogen.
(2) Fecal occult blood-non-automated;
(3) Ovulation tests - visual color comparison tests for human luteinizing hormone;
(4) Urine pregnancy tests - visual color comparison tests;
(5) Erythrocyte sedimentation rate - non-automated;
(6) Hemoglobin - copper sulfate - non-automated;
(7) Blood glucose by glucose monitoring devices cleared by the FDA specifically for home use;
(8) Spun microhematocrit; and
(9) Hemoglobin by single analyte instruments with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout.
(d) Revisions to criteria for test categorization and the list of waived tests. HHS will determine whether a laboratory test meets the criteria listed under paragraph (b) of this section for a waived test. Revisions to the list of waived tests approved by HHS will be published in the FEDERAL REGISTER in a notice with opportunity for comment.
(e) Laboratories eligible for a certificate of waiver must -
(1) Follow manufacturers' instructions for performing the test; and
(2) Meet the requirements in subpart B, Certificate of Waiver, of this part.
(a) Categorization by criteria. Notices will be published in the FEDERAL REGISTER which list each specific test system, assay, and examination categorized 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
42 CFR Part 493 (up to date as of 8/19/2022) Laboratory Requirements 42 CFR 493.15(c)(1)(i)
42 CFR 493.17(a) (enhanced display) page 16 of 180 https://www.federalregister.gov/citation/57-FR-7139 https://www.federalregister.gov/citation/58-FR-5221 https://www.federalregister.gov/citation/82-FR-48773
Note: A score of “2” will be assigned to a criteria heading when the characteristics for a particular test are intermediate between the descriptions listed for scores of “1” and “3.”
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.
(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 1. Operational steps are either automatically executed (such as pipetting, temperature monitoring, or timing of steps), or are easily controlled.
42 CFR Part 493 (up to date as of 8/19/2022) Laboratory Requirements 42 CFR 493.17(a)(1)
42 CFR 493.17(a)(4)(i) (enhanced display) page 17 of 180
(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
(C) External proficiency testing materials, when available, are stable.
(ii) Score 3.
(A) Calibration materials, if available, may be labile;
(B) Quality control materials may be labile, or not available; or
(C) External proficiency testing materials, if available, may be labile.
(6) Test system troubleshooting and equipment maintenance -
(i) Score 1.
(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.
(c) Process for device/test categorization utilizing the scoring system under § 493.17(a).
42 CFR Part 493 (up to date as of 8/19/2022) Laboratory Requirements 42 CFR 493.17(a)(4)(ii)
42 CFR 493.17(c) (enhanced display) page 18 of 180
[57 FR 7139, Feb. 28, 1992, as amended at 58 FR 5222, Jan. 19, 1993]
§ 493.19 Provider-performed microscopy (PPM) procedures.
(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
(C) If a manufacturer requests review of a categorization decision by FDA in 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.
(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…
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