Medicare, Medicaid and CLIA programs; extension of certain effective dates for clinical laboratory requirements and personnel requirements for cytologists--HCFA. Final rule with comment period

This final rule extends certain effective dates for clinical laboratory requirements in regulations published on February 28, 1992, which implemented provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and announces our approval of a certifying organization for qualifying cytotechnologists. This rule extends the date by which an individual must enroll in an HCFA-approved cytology proficiency testing (PT) program and the date by which an individual with a doctoral degree must possess board certification to qualify as a director of a laboratory that performs high complexity testing. In addition, we are extending the phase-in of the quality control requirements applicable to unmodified, moderate complexity tests cleared for commercial distribution by the Food and Drug Administration (FDA). We are extending the date to meet applicable CLIA QC requirements for laboratories using commercial, nonmodified tests to fulfill certain quality control (QC) requirements. These effective date extensions do not reduce the current requirements for quality test performance. The date extensions are necessary due to the limited number and scope of currently operating cytology PT programs, resource constraints that have prevented commencement of the substantial number of quality control reviews, and inability of many laboratory directors to complete certification requirements within the time period originally specified.     

Approval of the Commission on Office Laboratory Accreditation--HCFA. Notice

This notice announces the approval of the Commission on Office Laboratory Accreditation (COLA) as an accrediting organization for clinical laboratories under the CLIA program. We have found that the accreditation process of this organization provides reasonable assurance that the laboratories accredited by it meet the conditions required by Federal law and regulations. Consequently, laboratories that voluntarily become accredited by COLA in lieu of receiving direct Federal oversight and continue to meet COLA requirements would meet the CLIA condition level requirements for laboratories and therefore are not subject to routine inspection by State survey agencies to determine their compliance with Federal requirements. They are, however, subject to validation and complaint investigation surveys.     

CLIA program; approval of the College of American Pathologists--HCFA. Notice

This notice announces the approval of the College of American Pathologists (CAP) as an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have found that the accreditation process of this organization provides reasonable assurance that the laboratories accredited by it meet the conditions required by Federal law and regulations. Consequently, laboratories that voluntarily become accredited by CAP in lieu of receiving direct Federal oversight and continue to meet CAP requirements would meet the CLIA condition level requirements for laboratories and therefore are not subject to routine inspection by State survey agencies to determine their compliance with Federal requirements. They are, however, subject to validation and complaint investigation surveys.     

Approval of the Commission on Office Laboratory Accreditation for Immunohematology--HCFA. Notice

This notice announces the approval of the Commission on Office Laboratory Accreditation (COLA), which is an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments (CLIA) program, for the addition of the full specialty of immunohematology. This approval adds immunohematology to the specialties and subspecialties approved by HCFA in a notice published in the Federal Register on December 23, 1993 (58 FR 68148). We have found that the accreditation process of this organization provides reasonable assurance that the laboratories accredited by it for immunohematology meet the conditions required by Federal law and regulations. Consequently, laboratories that voluntarily become accredited by COLA for the specialty of immunohematology in lieu of receiving direct Federal oversight and continue to meet COLA requirements would meet the CLIA immunohematology condition level requirements for laboratories. These laboratories performing immunohematology testing are not subject to routine inspection by State survey agencies to determine their compliance with applicable Federal requirements. They are, however, subject to validation and complaint investigation surveys.     

Medicare, Medicaid, and CLIA programs; clinical laboratory requirements--extension of certain effective dates for clinical laboratory requirements under CLIA--CDC, HCFA. Final rule with comment period

This final rule extends certain effective dates for clinical laboratory requirements in regulations published on February 28, 1992, and subsequently revised December 6, 1994, that implemented provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This rule extends the phase-in date of the quality control requirements applicable to moderate and high complexity tests and extends the date by which an individual with a doctoral degree must possess board certification to qualify as a director of a laboratory that performs high complexity testing. These effective dates are extended to allow the Department additional time to issue revised quality control requirements and to ensure laboratory directors are able to complete certification requirements. These effective date extensions do not reduce the current requirements for quality test performance.     

Medicare, Medicaid and CLIA programs; revision of the laboratory regulations for the Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 programs--HCFA. Final rule with comment period

This rule revises regulations for laboratories regulated under the Medicare, Medicaid and Clinical Laboratories Improvement Act of 1967 (CLIA '67) programs. The revisions recodify the regulations for these programs into a new part 493 in order to simplify administration and unify the health and safety requirements for all programs as much as possible. We will now have a single set of regulations for the three programs, with an additional subpart for the licensure procedures unique to the CLIA program. We are revising the regulations to remove outdated, obsolete and redundant requirements, make provision for new technologies and place increased reliance on outcome measures of performance. We provide for new uniform proficiency testing standards. We have also added requirements for additional specialties, such as clinical cytogenetics. We also implement the now and self-implementing provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88).     

Medicare, Medicaid, and CLIA programs; extension of certain effective dates for clinical laboratory requirements under CLIA. Centers for Disease Control and Prevention (CDC) and Health Care Financing Administration (HCFA), HHS. Final rule with comment period

This final rule extends certain effective dates for clinical laboratory requirements in regulations published on February 28, 1992, that implemented provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This rule extends the phase-in date of the quality control requirements applicable to moderate and high complexity tests and extends the date by which an individual with a doctoral degree must possess board certification to qualify as a director of a laboratory that performs high complexity testing. These effective dates are extended to allow the Department to revise quality control requirements and establish the qualification requirements necessary for individuals with doctoral degrees to serve as directors of laboratories performing high complexity testing. These effective date extensions do not reduce the current requirements for quality test performance.     

Medicare, Medicaid, and CLIA programs; extension of certain effective dates for clinical laboratory requirements under CLIA--CDC, HCFA. Final rule with comment period

This final rule extends certain effective dates for clinical laboratory requirements in regulations published on February 28, 1992, and subsequently revised December 6, 1994, and May 12, 1997, that implemented provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This rule extends the phase-in date of the quality control requirements applicable to moderate and high complexity tests and extends the date by which an individual with a doctoral degree must possess board certification to qualify as a director of a laboratory that performs high complexity testing. These effective dates are extended to allow the Department additional time to issue revised quality control requirements and to determine whether changes are needed in the qualification requirements for individuals with doctoral degrees to serve as directors of laboratories performing high complexity testing. These effective date extensions do not reduce the current requirements for quality test performance.     

Clinical Laboratories Improvement Act program; granting and withdrawal of deeming authority to private nonprofit accreditation organizations and of CLIA exemption under state laboratory programs--HCFA. Final rule

This rule permits HCFA to approve or disapprove accreditation organizations and State laboratory programs and thereby determine that laboratories accredited by a HCFA-approved private, nonprofit accreditation organization are deemed to meet the requirements set forth in 42 CFR part 493 of the regulations, which implement section 353 of the Public Health Service Act (PHSA) or, in the case of State laboratory programs, are exempt from the requirements. Section 353 of the PHSA was enacted by the Clinical Laboratories Improvement Act of 1967 (CLIA '67) and was amended by the Clinical Laboratory Improvement Amendments of 1988 (CLIA).     

Medicare program; Medicare and laboratory certification program; enforcement procedures for laboratories--HCFA. Final rule

These regulations set forth the rules for sanctions that HCFA may impose on laboratories that are found not to meet Federal requirements. These include the principal sanctions of suspending, limiting, or revoking the laboratory's certificate issued under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), and cancelling the laboratory's approval to receive Medicare payment for its services, and the alternative sanctions that may be imposed instead of or before the principal sanctions. These amendments are necessary to conform HCFA regulations to changes made in the law by the Omnibus Budget Reconciliation Act of 1987 (OBRA '87) and the 1988 amendments to section 353 of the Public Health Service Act (PHS Act). The latter are commonly referred to as "CLIA 88". The purpose of the amendments is to ensure that functioning laboratories are capable of providing accurate and reliable test results and that the health of individuals served by the laboratory and that of the general public is not adversely affected by laboratory operations and by testing procedures that do not meet the standards set forth in other subparts of part 493 of the HCFA regulations.     

Medicare program; rural health clinics: amendments to participation requirements and payment provisions; and establishment of a quality assessment and performance improvement program. Final rule

This final rule amends Medicare certification and payment requirements for rural health clinics (RHCs) as required by the Balanced Budget Act of 1997 (BBA). It changes the definition of a qualifying rural shortage area in which a Medicare RHC must be located; establishes criteria for identifying RHCs essential to delivery of primary care services that we can continue to approve as Medicare RHCs in areas no longer designated as medically underserved; and limits waivers of certain nonphysician practitioner staffing requirements. This final rule imposes payment limits on provider-based RHCs and prohibits "commingling" (the use of the space, professional staff, equipment, and other resources) of an RHC with another entity. The rule also requires RHCs to establish a quality assessment and performance improvement program that goes beyond current regulations. Finally, this final rule addresses public comments received on the February 28, 2002 proposed rule and makes other revisions for clarity and uniformity and to improve program administration.     

Medicare, Medicaid, and CLIA programs; personnel requirements for cytotechnologists--HCFA. Final rule with comment period

This rule amends certain personnel requirements for cytotechnologists that perform testing in laboratories subject to the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). We are providing an adequate period of time for individuals to gain the necessary 2 years experience performing cytology testing which is currently included in two of the provisions for qualifying as a cytotechnologist. Also, we are extending the time for individuals to either meet the educational qualifications by virtue of completing training in an approved cytotechnology training program or be certified by an approved organization. We are making these changes to prevent the loss of qualified personnel in the field of cytotechnology.     

CLIA program; fee schedule revision--HCFA. General notice with comment period

This notice updates the certificate fees for laboratories established under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) consistent with the methodology set forth in 42 CFR part 493. Section 353 (m) of the Public health Service Act requires that fees be collected to recoup costs of general administration of the CLIA Program. By economizing at every opportunity, the CLIA program has managed to maintain the fees established in 1992 and has absorbed all increases in costs. Revisions to the fees are necessary because the current fees are no longer sufficient to support the administration of the CLIA program. This restructuring of fees will move equitably distribute fees across all sizes and complexity of laboratories. For purposes of simplification, this notice announces a flat fee of $100 for a certificate of registration.     

Medicare,Medicaid, and CLIA programs; laboratory requirements relating to quality systems and certain personnel qualifications. Final rule

This final rule revises and responds to comments on certain laboratory requirements issued pursuant to the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Pub. L. 100-578. Specifically, this final rule sets forth requirements for certain quality control (QC) provisions and personnel qualifications; consolidates and reorganizes the requirements for patient test management, QC, and quality assurance; and changes the consensus required for grading proficiency testing challenges. To ensure a smooth transition to the new provisions for directors of high complexity testing who are not board certified (but who have doctoral degrees), we will not be holding facilities out of compliance with the provisions of the rule concerning directors who are not board certified until the effective date of this new rule, to the extent the facilities are otherwise in compliance with the requirements for laboratory directors.     

Medicare, Medicaid and CLIA programs; regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA)--HCFA. Final rule with comment period

This final rule revises regulations applicable to laboratories and implements provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 100-578. The regulation applies to laboratories that examine human specimens for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. They specify the performance requirements, based on 19 test complexity and risk factors related to erroneous test results, that apply to laboratories that are subject to CLIA. They also list requirements for laboratories performing certain limited testing to be eligible for a certificate of waiver. These laboratories will not be inspected routinely, nor will they be required to meet certain other CLIA requirements.     

Clinical Laboratory Improvement Act program fee collection--HCFA. Final rule with comment

This rule implements provisions of section 353 of Public Health Service Act (as amended by the Clinical Laboratory Improvement Amendments of 1988). Those provisions require laboratories to pay fees for issuance of registration certificates, certificates of waiver, certificates of accreditation, or certificates and to fund activities to determine compliance with the requirements established by the Department of Health and Human Services for laboratory testing. It also establishes the policy that laboratories licensed by and located in States with licensure programs approved by HHS may be exempt from the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This rule also establishes the methodology used to determine the amount of the fees charged for certificates of waiver, registration certificates, certificates of accreditation, or certificates and activities to establish application procedures and determine compliance with applicable certification requirements.     

Medicare, Medicaid and CLIA programs; regulations implementing the Clinical Laboratory Improvement Amendments of 1988--HCFA. Final rule; correction

On January 19, 1993, we updated the rules originally published on February 28, 1992, concerning requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). We have identified a number of typographical errors and we are correcting them in this notice. We also add regulatory text that was inadvertently omitted on January 19, 1993 relating to quality control requirements for cytology testing and qualifications for general supervision.     

Medicare, Medicaid, and CLIA programs; Clinical Laboratory Improvement Amendments of 1988 continuance of exemption of laboratories licensed by the State of Washington--HCFA. Notice

This notice announces that laboratories located in the State of Washington that possess a valid license under the Medical Test Site Licensure Law, Chapter 70.40 of the Revised Code of Washington (RCW), continue to be exempt from the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) until April 30, 2001.     

Medicare, Medicaid and CLIA programs; regulations implementing the Clinical Laboratory Improvement Amendments of 1988--HCFA. Final rule; correction

In the January 19, 1993 issue of the Federal Register (FR Doc. 93-1169) (58 FR 5215), we updated the rules concerning requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). We have identified an error in the text of the regulations and we are correcting it in this notice.     

Medicare, Medicaid and CLIA programs; CLIA program fee collection; correction--HCFA. Correcting amendments

This rule corrects a technical error in a rule entitled, "Regulations Implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA)" which inadvertently deleted some content of another rule entitled, "CLIA Program Fee Collection." Both rules were published in the Federal Register on February 28, 1992. We are restoring, without change, the content of sections 493.602 through 493.634, which was incorrectly removed effective September 1, 1992.