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.     

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, 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.     

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 (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.     

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.     

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.     

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 program; Medicare and Laboratory Certification Program; enforcement procedures for laboratories--HCFA. Correction notice

In the February 28, 1992 issue of the Federal Register (FR Doc. 92-4050) (57 FR 7218), we established rules for sanctions that HCFA may impose on laboratories that are found not to meet Federal requirements. This notice corrects both typographical and technical errors made in that document.     

CLIA program; simplifying CLIA regulations relating to accreditation, exemption of laboratories under a state licensure program, proficiency testing, and inspection--HCFA. Final rule

This final rule responds to selected comments received on a final rule with a comment period implementing the Clinical Laboratory Improvement Amendments of 1988, which was published in the Federal Register on February 28, 1992, in the areas of proficiency testing and inspections for clinical laboratories. In responding to these comments, we accommodate, when possible, the Administration's regulatory reform initiative by reducing duplicative material, emphasizing outcome-oriented results, and simplifying regulations. In that regard, we also are streamlining our regulations in the areas of State exemption, and granting deemed status to laboratories accredited by an approved accreditation organization.     

Medicaid program; Medicaid Management Information System (MMIS) performance review; notification procedures for changes in requirements, performance standards, and reapproval conditions--HCFA. Final rule

This rule eliminates the requirement in the Medicaid regulations that HCFA meet certain Federal Register notification requirements for any changes in performance standards and other conditions for reapproval of State Medicaid Management Information Systems (MMISs), even if such Federal Register notice would not otherwise be required. An independent Federal Register publication requirement will remain in place with respect to changes in system requirements and other conditions for approval of MMISs. We believe that a revised process for notifying States and other concerned parties of changes in performance standards and other conditions of reapproval is appropriate and will facilitate the efficient issuance of revised MMIS review requirements and methodologies each year.     

Medicare program; required laboratory procedures for rural health clinics--HCFA. Final rule with comment period

This rule revises the range of laboratory tests rural health clinics (RHCs) are required to provide in order to meet the Medicare conditions of participation. We are eliminating tests not classified as waived under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). RHCs that elect to furnish tests not waived under CLIA must comply with CLIA requirements as specified in regulations on Laboratory Requirements and will receive appropriate payment for covered laboratory services. We are making these changes because the CLIA program introduced participation requirements that may cause some RHCs to withdraw from the program, creating a shortage of available medical care in some areas.     

Current list of laboratories which meet minimum standards to engage in urine drug testing for federal agencies, and laboratories that have withdrawn from the program--SAMHSA. Notice

The Department of Health and Human Services notifies Federal agencies of the laboratories currently certified to meet standards of Subpart C of Mandatory Guidelines for Federal Workplace Drug Testing Programs (59 FR 29916, 29925). A similar notice listing all currently certified laboratories will be published during the first week of each month, and updated to include laboratories which subsequently apply for and complete the certification process. If any listed laboratory's certification is totally suspended or revoked, the laboratory will be omitted from updated lists until such time as it is restored to full certification under the Guidelines. If any laboratory has withdrawn from the National Laboratory Certification Program during the past month, it will be identified as such at the end of the current list of certified laboratories, and will be omitted from the monthly listing thereafter. This Notice is now available on the internet at the following website: http://www.health.org.     

Medicare program; recognition of the Community Health Accreditation Program standards for home care organizations--HCFA. Final notice

This final notice recognizes accreditation by the Community Health Accreditation Program (CHAP), a subsidiary of the National League for Nursing (NLN), for home health agencies (HHAs) that wish to participate in the Medicare Program. As a result of this recognition, HHAs accredited by CHAP are deemed to meet the Medicare conditions of participation for HHAs to the extent described in this notice. This final notice sets forth certain specific requirements with which CHAP must comply to maintain Medicare recognition of its HHA accreditation program.     

Medicare and Medicaid programs; recognition of the Joint Commission on Accreditation of Healthcare Organizations standards for home care organizations--HCFA. Final notice

This final notice recognizes accreditation by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) for home health agencies (HHAs) that wish to participate in the Medicare or Medicaid programs. As a result of this recognition, HHAs accredited by JCAHO are deemed to meet the Medicare conditions of participation for HHAs to the extent described in this notice. This final notice sets forth certain specific requirements with which JCAHO must comply to maintain Medicare and Medicaid recognition of its HHA accreditation program.     

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

In the February 28, 1992, issue of the Federal Register (57 FR 7002), the Department of Health and Human Services established rules that set forth the test performance requirements for laboratories that are subject to the CLIA requirements. This rule corrects both typographical and technical errors made in that document as well as provides some additional clarification after a limited review of the comments we received after the publication of the rule.     

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.