Date
|
Regulation #
|
Reference
|
Publication Title
|
|
| 03/25/2005 |
CMS-2211-N
|
70 FR 15327 |
Medicare, Medicaid, and CLIA Programs; Continuance of the Approval of the American Society for Histocompatability and Immunogenetics as a CLIA Accreditation Organization
Notice announcing the continuance of the approval of the American Society for Histocompatability and Immunogenetics (ASHI) as an accreditation organization for clinical laboratories under CLIA '88 until March 25, 2005.
Text or PDF
|
Code of Federal
Regulations (10/2004) Part 493 Laboratory Requirements
Text or PDF
This document contains the codified CLIA regulations as of October 1,
2004 and includes the documents denoted with -F, -FC or -CN (listed below).
|
| 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 |