Date
|
Regulation #
|
Reference
|
Publication Title
|
|
11/13/2003 |
|
68 FR
64350 |
Food and Drug Administration; Delegation of Authority
Notice that the Commissioner of Food and Drugs has been given the authority to
implement CLIA's complexity categorization provisions.Text
or PDF
|
Code of Federal
Regulations (10/2003) Part 493 Laboratory Requirements
Text or PDF
This document contains the codified CLIA regulations as of October 1,
2003 and includes the documents denoted with -F, -FC or -CN (listed below).
|
08/22/2003 |
CMS-2226-CN
|
68 FR 50722 |
Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating
to Quality Systems and Certain Personnel Qualifications; Correction
Text or PDF |
01/24/2003 |
CMS-2226-F
Press Release
|
68
FR 3639 |
Medicare, Medicaid, and CLIA Programs;LaboratoryRequirements
Relating
to Quality Systems and Certain Personnel Qualifications; Final Rule
Text or PDF |
Code of Federal
Regulations (10/2002) Part 493 Laboratory Requirements
Text or PDF
This document contains the codified CLIA regulations as of October 1,
2002 and includes the documents denoted with -F, -FC or -CN (listed below).
|
10/25/2002 |
CMS-2159-N |
67 FR 65585 |
Continuance of Approval of the Joint Commission on Accreditation of Healthcare
Organizations (JCAHO) as an Accrediting Organization Text
or PDF |
03/22/2002 |
CMS-2138-N |
67 FR 13341 |
Continuance of the Approval of the American Osteopathic Association (AOA) as a
CLIA Accreditation Organization Text or
PDF |
12/28/2001 |
CMS-2094-P |
66 FR 67163 |
Medicare, Medicaid, and CLIA Programs; Qualification Requirements
for Directors of Laboratories Performing High Complexity Testing
Text or PDF |
Code of Federal
Regulations (10/2001) Part 493 Laboratory Requirements
Text or PDF
This document contains the codified CLIA regulations as of October 1,
2001 and includes the documents denoted with -F, -FC or -CN (listed below).
|
09/12/2001 |
CMS-2119-N |
66 FR 47493 |
Continuance of the Approval of the College of American Pathologists as a CLIA
Accreditation Organization Text or
PDF |
03/05/2001 |
HCFA-2068-N |
65 FR 13328 |
Medicare, Medicaid, and CLIA Programs; Continuance of the Approval of the
American Society for Histocompatibility and Immunogenetics as a CLIA
Accreditation Organization Text
or PDF |
12/29/2000 |
HCFA-2024-FC2 |
65 FR 82941 |
Medicare, Medicaid, and CLIA Programs; Extension of Certain Effective Dates for
Clinical Laboratory Requirements Under CLIA Text
or PDF |
Code of Federal
Regulations (10/2000) Part 493 Laboratory Requirements
Text or PDF
This document contains the codified CLIA regulations as of October 1,
2000 and includes the documents denoted with -F, -FC or -CN (listed below).
|
11/24/2000 |
HCFA-2118-CN |
65 FR 70575 |
Medicare, Medicaid, and CLIA Programs; Continuance of the Approval of COLA as a
CLIA Accreditation Organization; Correction Text
or PDF
|
10/31/2000 |
HCFA-2118-N |
65 FR 64966 |
Medicare, Medicaid, and CLIA Programs; Continuance of the Approval of COLA as a
CLIA Accreditation Organization Text or
PDF
|
05/04/2000 |
|
65 FR 25928 |
Genetic Testing Under the Clinical Laboratory Improvement Amendments (CLIA)
Text or PDF
|
05/03/2000 |
|
65 FR 25295 |
Notice of Specific List for Categorization of Laboratory Test Systems, Assays,
and Examinations by Complexity Text or
PDF
|
05/02/2000 |
HCFA-2117-N |
65 FR 25492 |
Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement
Amendments of 1988 Removal of Exemption of Laboratories in the State of Oregon
Text or PDF
|
03/17/2000 |
HCFA-2233-N |
65 FR 14510 |
CLIA Program; Cytology Proficiency Testing
Text or PDF |
Code of Federal
Regulations (10/1999) Part 493 Laboratory Requirements
Text or PDF
This document contains the codified CLIA regulations as of October 1,
1999 and includes the documents denoted with -F, -FC or -CN (listed below).
|
12/30/1999 |
|
64 FR 73561 |
CLIA Program; Transfer of Clinical Laboratory Complexity
Categorization Responsibility Text or
PDF |
09/23/1999 |
|
64 FR 51590 |
Notice of Specific List for Categorization of Laboratory Test
Systems, Assays, and Examinations by Complexity Text
or PDF |
10/14/1998 |
HCFA-2024-FC |
63 FR 55031 |
Medicare, Medicaid, and CLIA Programs; Extension of Certain
Effective Dates for Clinical Lab Requirements Under CLIA
Text or PDF |
Code of Federal
Regulations (10/1998) Part 493 Laboratory Requirements
Text or PDF
This document contains the codified CLIA regulations as of October 1,
1998 and includes the documents denoted with -F, -FC or -CN (listed below).
|
6/15/1998 |
HCFA-2239-F
(Corrections) |
63 FR 26722 |
CLIA Program; Simplifying CLIA Regulations Relating to
Accreditation, Exemption of Laboratories Under a State Licensure Program,
Proficiency Testing, and Inspection Text
or PDF |
5/14/1998
|
HCFA-2239-F
|
63 FR 26722
|
CLIA Program; Simplifying CLIA Regulations Relating to
Accreditation, Exemption of Laboratories Under a State Licensure Program,
Proficiency Testing, and Inspection Text
or PDF
|
4/19/1998
|
HCFA-2246-N
|
63 FR 17429
|
Medicare, Medicaid, and CLIA Programs; Clinical
Laboratory Improvement Amendments of 1988 Continuance of Approval as an
Accrediting Organization: Joint Commission on the Accreditation of Healthcare
Organizations (JCAHO); American Association of Blood Banks (AABB); and American
Osteopathic Association (AOA) Text
or PDF
|
Code of Federal
Regulations (10/1997) Part 493 Laboratory Requirements
Text or PDF
This document contains the codified CLIA regulations as of October
1997 and includes the documents denoted with -F, -FC or -CN (listed below).
|
8/29/1997
|
HSQ-219-GNC
|
62 FR 45815
|
CLIA Program; Fee Schedule Revision
Text or PDF
|
7/1/1997
|
HSQ-243-N
|
62 FR 35513
|
Medicare, Medicaid, and CLIA Programs; Clinical
Laboratory Improvement Amendments of 1988 Continuance of Exemption of
Laboratories Licensed by the State of Washington
Text or PDF
|
5/19/1997
|
HSQ-242-N
|
62 FR 27262
|
Approval of the Commission on Office Laboratory
Accreditation for Immunohematology Text
or PDF
|
5/12/1997
|
HSQ-237-FC
|
62 FR 25855
|
Medicare, Medicaid, and CLIA Programs; Clinical
Laboratory Requirements--Extension of Certain Effective Dates for Clinical
Laboratory Requirements under CLIA Text
or PDF
|
04/11/1997
|
|
62 FR 17832
|
Notice of Specific List for Categorization of
Laboratory Test Systems, Assays, and Examinations by Complexity
Text or PDF
|
02/05/1997
|
HSQ-244-N
|
62 FR 5433
|
CLIA Program; Clinical Laboratory Improvement
Amendments of 1988 - Denial of Exemption of Laboratories in the Commonwealth of
Puerto Rico Text or
PDF
|
07/08/1996
|
|
61 FR 35736
|
Notice of Specific List for Categorization of
Laboratory Test Systems, Assays, and Examinations by Complexity; Notice of
Additional Waived Laboratory Test Systems, Assays, and Examinations; and Notice
of Announcement of Boards Approved by HHS
Text or PDF
|
06/13/1996
|
HSQ-231-N
|
61 FR 30072
|
Medicare, Medicaid, and CLIA Programs; Clinical
Laboratory Improvement Amendments of 1988 Exemption of Laboratories in the
State of Oregon Text or
PDF
|
11/30/1995
|
HSQ-233-P
|
60 FR 61509
|
CLIA Programs; Cytology Proficiency
Testing Text or
PDF
|
09/15/1995
|
HSQ-222-P
|
60 FR 47982
|
CLIA Program; Categorization and Certification
Requirements for a New Subcategory of Moderate Complexity Testing
Text or PDF
|
09/13/1995
|
HSQ-225-P
|
60 FR 47534
|
Public Health Service; CLIA Program; Categorization of
Waived Tests Text or
PDF
|
08/28/1995
|
HSQ-230-N
|
60 FR 44503
|
Medicare, Medicaid, and CLIA Programs; Clinical
Laboratory Improvement Amendments of 1988 Exemption of Permit-Holding
Laboratories in the State of New York Text
or PDF
|
07/21/1995
|
HSQ-229-N
|
60 FR 37657
|
CLIA Program; Approval of the American Osteopathic
Association as an Accrediting Organization
Text or PDF
|
07/21/1995
|
HSQ-228-N
|
60 FR 37660
|
CLIA Program; Approval of the American Association of
Blood Banks Text or
PDF
|
05/15/1995
|
|
60 FR 25944
|
Specific List for Categorization of Laboratory Test
Systems, Assays, and Examinations by Complexity
Text or PDF
|
04/24/1995
|
HSQ-216-FC
|
60 FR 20035
|
CLIA Program; Categorization of Tests and Personnel
Modifications Text or
PDF
|
02/09/1995
|
HSQ-223-N
|
60 FR 7774
|
CLIA Program; Approval of the College of American
Pathologists Text or
PDF
|
01/03/1995
|
HSQ-224-N
|
60 FR 130
|
CLIA Program: Approval of the Joint Commission on
Accreditation of Healthcare Organizations as an Accrediting
Organization Text
|
12/23/1994
|
HSQ-221-N
|
59 FR 66314
|
Medicare, Medicaid and CLIA Programs; Clinical
Laboratory Amendments of 1988 Continuance of Exemption of Laboratories Licensed
by the State of Washington Text
|
12/06/1994
|
HSQ-217-FC
|
59 FR 62606
|
Medicare, Medicaid and CLIA Programs; Extension of
Certain Effective Dates for Clinical Laboratory Requirements and Personnel
Requirements for Cytologists Text
|
10/20/1994
|
HSQ-220-N
|
59 FR 52968
|
CLIA Program; Approval of the American Society for
Histocompatibility and Immunogenetics (ASHI) for the Specialty of
Histocompatibility Text
|
01/06/1994
|
HSQ-210-FC
|
59 FR 682
|
Medicare, Medicaid and CLIA Programs; Personnel
Requirements for Cytotechnologists Text
|
The items listed below are not available in an electronic
format.
|
12/23/1993
|
HSQ-211-N
|
58 FR 68148
|
Approval of the Commission on Office Laboratory
Accreditation (COLA)
|
10/6/1993
|
HSQ-209-N
|
58 FR 52115
|
Medicare, Medicaid and CLIA Programs: CLIA '88
Exemption of Laboratories Licensed by the State of Washington
|
07/26/1993
|
|
58 FR 39860
|
Compiled List for Categorization of Laboratory Test
Systems, Assays, and Examinations by Complexity
|
07/22/1993
|
HSQ-202-CN
|
58 FR 39154
|
Medicare, Medicaid and CLIA Programs; Regulations
Implementing the Clinical Laboratory Improvement Amendments of 1988
|
01/19/1993
|
HSQ-206-F
|
58 FR 5212
|
Medicare, Medicaid and CLIA Programs; CLIA Program Fee
Collection; Correction
|
01/19/1993
|
HSQ-202-FC
|
58 FR 5215
|
Medicare, Medicaid and CLIA Programs; Regulations
Implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and
Clinical Laboratory Improvement Act Program Fee Collection
|
10/01/1992
|
|
57 FR 45392
|
Deletion of text from previously published notice
|
09/02/1992
|
|
57 FR 40239
|
Specific List for Categorization of Laboratory Test
Systems, Assays, and Examinations by Complexity, Notice
|
08/28/1992
|
|
57 FR 39211
|
Specific List for Categorization of Laboratory Test
Systems, Assays, and Examinations by Complexity
|
08/11/1992
|
HSQ-176-CN
|
57 FR 35760
|
Medicare Program; Medicare and Laboratory
Certification Program; Enforcement Procedures for Laboratories
|
07/31/1992
|
HSQ-181-F
|
57 FR 33992
|
Clinical Laboratories Improvement Program; Granting
and Withdrawal of Deeming Authority to Private Nonprofit Accreditation
Organizations and or CLIA Exemptions Under State Laboratory Programs
|
07/08/1992
|
|
57 FR 30362
|
Specific List for Categorization of Laboratory Test
Systems, Assays, and Examinations by Complexity
|
02/28/1992
|
|
57 FR 7245
|
Specific List for Categorization of Laboratory Test
Systems, Assays, and Examinations by Complexity
|
02/28/1992
|
HSQ-179-F
|
57 FR 7218
|
Medicare Program, Medicare and Laboratory
Certification Program; Enforcement Procedures for Laboratories
|
02/28/1992
|
HSQ-177-FC
|
57 FR 7188
|
Clinical Laboratory Improvement Act Program; Fee
Collection
|
02/28/1992
|
HSQ-176-FC
|
57 FR 7002
|
Medicare, Medicaid and CLIA Programs; Regulations
Implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
|
04/02/1991 |
HSQ-179-P |
56 FR 13430 |
Medicare and Laboratory Certification Programs; Enforcement
Procedures for Laboratories |
08/20/1990 |
HSQ-146-CN |
55 FR 33907 |
Medicare, Medicaid and CLIA Programs; Revisions of the Laboratory
Regulations for the Medicare, Medicaid, and Clinical Laboratories Improvement
Act of 1967 Programs; correction |
08/20/1990 |
HSQ-181-P |
55 FR 33936 |
Clinical Laboratory Improvement Act Program; Granting and
Withdrawal of Deeming Authority to Private Nonprofit Accreditation
Organizations and State Licensure Agencies |
08/03/1990 |
HSQ-177-P |
55 FR 31758 |
Clinical Laboratory Improvement Act Programs; Fee Collection |
05/21/1990 |
HSQ-176-P |
55 FR 20896 |
Medicare, Medicaid and CLIA Programs: Regulations Implementing the
Clinical Laboratory Improvements of 1988 (CLIA '88) |
03/14/1990 |
HSQ-146-F |
55 FR 9538 |
Medicare, Medicaid and CLIA Programs; Revisions of the Laboratory
Regulations for the Medicare, Medicaid, and Clinical Laboratory Improvement Act
of 1967 Programs |
10/31/1988 |
P.L. 100-578 |
Public Law |
CLIA '88 |
09/29/1988 |
S.R. 100-561 |
Senate Report |
Medical Testing Improvement Act of 1988 |
09/09/1988 |
H.R. 100-899 |
House Report |
Clinical Laboratory Improvement Amendments of 1988 |
08/05/1988 |
HSQ-146-P |
53 FR 29590 |
Medicare, Medicaid and CLIA Programs; Revision of the Clinical
Laboratory Regulations for the Medicare, Medicaid, and Clinical Laboratories
Improvement Act of 1967 Programs |