42 CFR Part 493 [CMS-3355-RCN] RIN 0938-AT55 Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing . 493.1253 Standard: Establishment and verification of performance specifications. If your laboratory receives a CLIA fee with a pink slip, this fee needs to be paid within two weeks of date of the notice to avoid termination of your CLIA certificate. The governing regulations for laboratories are 42CFR Part 493, which explains the process by which laboratories can apply for one or more certificates to test certain categories of tests (waived . PART 493 - LABORATORY REQUIREMENTS; Subpart K - Quality System for Nonwaived Testing; Preanalytic Systems 493.1242 Standard: Specimen submission, handling, and referral. Rules governing the certification of all clinical laboratories are contained in the Code of Federal Regulations (CFR) at 42 CFR Part 493Laboratory Regulations.

493.561 Denial of application or reapplica- CDC, in partnership with CMS and FDA , supports the CLIA program and clinical laboratory quality. Clinical laboratories that use Web-based software solutions to comply with regulations . NC Division of Health Service Regulationadministering the regulations in North Carolina. VerDate Sep<11>2014 16:08 May 06, 2021 Jkt 253001 PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 E:\FR\FM\07MYR1.SGM 07MYR1 Waived tests are those tests that have been determined to be so simple that if performed incorrectly will pose no risk of harm. Condition: Reporting of SARS-CoV-2 test results. The most current version of the CLIA regulations Part 493, including all changes through 5/12/14. 7. SECTION 493.1775. The regulations cover all aspects of testing including general laboratory requirements, quality monitors . The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.

QA for Moderate/High Complexity Labs (including PPM) QA for Waived Labs; IQCP Workbook; Additional Information. 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). Part 493-Laboratory Re quirements in effect on September 22, 2003. FDA Guidance: Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects [Oct 2009] 6. The Clinical Laboratory Improvement Amendments (CLIA) of 1988 and the CLIA Final Rule set . Public Law 100-578 CLIA '88 signed by President on October 31, 1988 CLIA final rules 42 CFR part 493 (administrative processes and quality standards) published on February 28, 1992 CLIA final rules effective on September 1, 1992 Uniform standards to ensure accuracy, reliability and timeliness CLIA History Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance, 1536-1567 [2018-28363] D5417: since the D tag is odd numbered, a standard level deficiency is indicated. The Secretary established the initial regulations implementing CLIA on February 28, 1992 at 42 CFR part 493 . The Clinical Laboratory Improvement Amendments (CLIA) program, administered by the Centers for Medicare and Medicaid Services (CMS), and the Department of Human . . Laboratories are not required to verify or establish performance specifications for any test system used by the laboratory before April 24, 2003.

Purpose: This procedure describes the steps necessary to become certified as a CLIA laboratory. D5991 As specified in 493.1443, the designated individual must meet one or more of the qualifying options listed . of this part. 493.569 Survey protocols and interpretive guidelines are established pursuant to pertinent sections of the Social Security Act, the Public Health Service Act, the Clinical Laboratory Improvement Amendments (CLIA) of 1988, and the CLIA regulations at 42 CFR Part 493 to provide guidance to personnel conducting surveys of laboratories. The CLIA regulations promulgated quality standards based on test complexity and established quality requirements for laboratories, similar - yet different - from the quality system requirements established by the FDA for device manufacturers. The CLIA Regulations and Interpretive guidelines specify that laboratories must enroll in proficiency testing (PT) for all regulated specialties, subspecialties and analytes (493.801, D2000) and verify the accuracy twice annually for all non-regulated analytes (493.1236, D5217). 493.5 Categories of tests by complexity. CLIA Laboratory . Copies of the CLIA regulations, 42 CFR Part 493 are available from the CMS website at . CLIA participation requirements are set forth in applicable regulations at 42 C.F.R. 493.2 Definitions. 6. CMS may take Laboratory Director Qualification Requirements . (As of 2013 and stated in The Code of Federal Regulations, CFR42 Part 430, Appendix C, Subpart J, 493.1105 Standard: Record Retention requirements) Listed are the CLIA requirements for retaining patient and testing records, specimens, and slides. Subpart J - Facility Administration - Sections 493.1100 through 493.1105 . 493.565 Selection for validation inspection--laboratory responsibilities. NOTE: Over 50 FR Notices/regulations published related to CLIA 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2009 2011 2013 2014 Statute enacted Proposed rule Final rule with comment . GUIDELINES: The guidelines that must be followed by each laboratory include all components of the CLIA '88 Final Rule (42 CFR Part 493) as published 1/24/2003 . Use D5401, if the procedure manual lacks any of the applicable information as specified in 493.1251 (b) (1)- (14). Under routine conditions, please allow approximately 2-3 weeks for processing. Consistent with the CLIA requirements, all L.) 102-139, Sec. 493.567 Refusal to cooperate with validation inspection. CLIA Regulations 42 CFR Part 493; Survey Procedures and Interpretive Guidelines; Quality Assurance. These CLIA regulations helped to establish quality standards for all U.S. laboratory testing performed on human specimens (except for research) for the purpose of assessment of health, or the diagnosis, prevention, or treatment of disease. 5. Please click the banner below to pay your CLIA fee. Aspen Federal Regulation Set: D 09.03 CLIA REGULATIONS Refer to 493.1773 and 493.1775 for additional guidelines for inspecting laboratories issued a certificate of waiver. The CLIA regulations can be found in the Code of Federal Regulations in volume 42 part 493. A condition of participation is a broadly stated general requirement that a laboratory must meet in order to qualify to participate under CLIA. Publication of approval of deeming authority or CLIA exemption. Use the information below as a guideline when establishing your laboratory's policies and procedures for record retention CLIA regulations set forth in 42 CFR Part 493. Regulations, Title 42, Part 493.15. 2 The CLIA regulations have often been compared to a three-legged stool, resting on requirements for personnel qualifications and two . authority or CLIA exemption. 5. CLIA established uniform quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results . These rules bring ALL non-waived (moderate and high complexity) testing under uniform QC requirements, including validation of methods. 3. The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1363 to perform the functions specified in 493.1365 for the volume and complexity of testing performed.

. (1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or The more complex the test systems . which are codified at 42 CFR Part 493. b. VHA is exempted from CLIA-88 per Public Law 102-139 (1991) and is required to develop regulations, in consultation with HHS, establishing standards equal to that applicable to other medical facility laboratories in accordance with the requirements of section 353(f) of the Public Health Service Act . The Clinical Laboratory Act (or CLIA) regulates the safety and effectiveness of clinical laboratory diagnostic testing. Electronic Code of Federal Regulations (e-CFR) Title 42 - Public Health . U.S. Code of Federal Regulations, Title 42, Part 493 (CLIA) 4. International Council for Harmonisation Good Clinical Practice (ICH E6) 5. CLIA program, in accordance with the accreditation requirements in the CLIA regulations at subpart E of 42 CFR part 493, and participate in an HHS approved proficiency testing program. regulations for CLIA under Title 42, Code of Federal Regulations (CFR) Part 493. b. Their commitment to quality is critical to their success . Obtain Certification for a Clinical Laboratory (Improvements Amendments of 1988 (CLIA) Laboratory. The laboratory must refer a specimen for testing only to a CLIA-certified laboratory or a . Interpretive Guidelines 493.1251 (a): Procedures may be organized in the form of manuals, stored in computers and/or card files. Multiple laboratories may operate at the same physical location (e.g., same building or suite, as applicable) with separate CLIA numbers as . Notification requirements for laboratories issued a certificate of waiver. Oregon Revised Statute Chapter 438 and 42 CFR Part 493 are carried out. . If you'd like more information about these regulations, please read the Code of Federal Regulations part 493. Rules and Regulations. The program conducts on-site inspections for compliance, monitors accuracy and reliability . Each agency has a unique role in assuring quality laboratory testing. While CLIA sets the minimum testing requirements, testing sites can and do choose to meet the . 493.3 Applicability. The CLIA - Clinical Laboratory Improvement Amendment Consists of a Series of Amendments (42 CFR 493) for Establishing Laboratory Standards.

If your CLIA certificate terminates, you are no longer allowed to test or get reimbursed for testing. This application may be mailed to: 201 Monroe Street, Suite 700, Montgomery, Alabama 36104; emailed to the Administrative Support Assistant at CLIAAlabama@adph.state.al.us; or faxed to CLIA at 334-206-5254. Many labs must also comply with FDA regulations such as 21 CFR Part 11 for maintaining their electronic records. NOTE: For additional qualifications please refer to CLIA regulations at 42CFR Part 493.1405 or contact your state CLIA Program. than the requirements of the CLIA regulations. D5990 493.1361 Condition: Laboratories performing PPM procedures; testing personnel. 493.563 Validation inspections--Basis and focus.

The laboratory must comply with CLIA registration and certificate requirements and follow the manufacturer's instructions for test performance. CLIA Regulations with Document Control Software. The laboratory director must be qualified to manage and direct the laboratory personnel and performance of high complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R. Healthcare organizations need to assess their lab personnel qualification and competency to assure that they are meeting the standard requirements pursuant to CLIA regulations, state regulations, and accreditation requirements. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on The program monitors all clinical laboratories for compliance to federal (42 Code of Federal Regulations Part 493) Clinical Laboratory Improvement Amendments of 1988 (CLIA)) and state requirements (Ohio Revised Code Chapter 3725 Plasmapheresis Centers). The CLIA Regulations and Interpretive Guidelines are an extremely important tool for surveyors and laboratory personnel. (10) "CLIA" means Section 353 of the Public Health Service Act, Clinical Laboratory Improvement Amendments of 1988, and regulations implementing the federal amendments, 42 C.F.R. This information is on the Centers for Disease Control and Prevention (CDC) website; A chronological list containing on-line copies of the CLIA regulations and related Federal Register publications (CDC Site); In accordance with 493.19 (b), the moderate complexity procedures specified as PPM procedures are considered such only when personally performed by a health care provider during a patient visit in the context of a physical examination. issue this final rule to revise and update the CLIA PT regulations. report are set forth in 42 CFR 493.1291. 493.561 Denial of application or reapplication. The Centers for Medicare & Medicaid Services (CMS) implements the CLIA program which is based on regulations found in 42 Code of Federal Regulations (CFR) Part 493. The laboratory must review specialties, subspecialties and _____ Karuna Seshasai, Executive Secretary to the Department, Department of Health and Human Services. Oregon Administrative Rule (OAR) for Oregon clinical laboratories (Chapter 333-024) Oregon Revised Statute (ORS) for Oregon clinical laboratories; Synopsis of the OAR for clinical laboratories (pdf) 42 CFR Part 493 - Federal CLIA regulations 42:5..1.1.9.15.41.3. Passed the HHS exam for technologist between March 1, 1986 and Dec 31, 1987 and prior to Jan 1,1994, met the requirements of a general supervisor in effect before Feb. 28,1992. 493.1443 Standard; Laboratory director qualifications. Those regulations required, among other things, for laboratories conducting moderate or high-complexity testing to enroll in an approved proficiency testing (PT) program for each specialty, subspecialty, and analyte or test for which . If the laboratory has procedures that are not used for test performance, but are used for . 493.41.

42 CFR Part 493 - LABORATORY REQUIREMENTS CFR prev| next Subpart A - General Provisions ( 493.1 - 493.25) Subpart B - Certificate of Waiver ( 493.35 - 493.41) Subpart C - Registration Certificate, Certificate for Provider-performed Microscopy Procedures, and Certificate of Compliance ( 493.43 - 493.53)