United States Government Publishing Office
publisher
pbl
distributor
dst
United States
National Archives and Records Administration
Office of the Federal Register
author
aut
Government Organization
text
government publication
eng
FR
Regulatory Information
executive
2017-01-09
article
Medicare, Medicaid and CLIA Programs; Extension of Certain Effective Dates for Clinical Laboratory Requirements and Personnel Requirements for Cytologists
UNKNOWN
D09002ee1be069b7d
United States
Department of Health and Human Services
originator
org
United States Government Agency or Subagency
United States
Health Care Financing Administration
originator
org
United States Government Agency or Subagency
United States
Public Health Service
originator
org
United States Government Agency or Subagency
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.
59 FR 0
https://www.govinfo.gov/app/details/FR-1994-12-06/94-29914
94-29914
fr06de94-13
RIN 0938-AG86
4120-01-P
Federal Register: December 6, 1994
HSQ-217-FC
https://www.govinfo.gov/app/details/FR-1994-12-06/94-29914
https://www.govinfo.gov/content/pkg/FR-1994-12-06/html/94-29914.htm
1 p.
0
0
59 FR 0
Code of Federal Regulations
Title 42 Part 493
42 CFR Part 493
Regulation Identification Number 0938-AG86
RIN 0938-AG86
Medicare, Medicaid and CLIA Programs; Extension of Certain Effective Dates for Clinical Laboratory Requirements and Personnel Requirements for Cytologists; Federal Register Vol. 59, Issue
UNKNOWN
94-29914
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
Public Health Service
1994-12-06
1996-02-06
Federal Register: December 6, 1994
HSQ-217-FC
4120-01-P
94-29914
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.
These regulations are effective on December 6, 1994. Comments will be considered if we receive them at the appropriate address, as provided below, no later than 5 p.m. on February 6, 1996.
Josephine A. Simmons (410) 597-5882.
Federal Register
Vol. 59, no. 233
Office of the Federal Register, National Archives and Records Administration
1994-12-06
continuing
daily
deposited
born digital
436 p.
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-1994-12-06
P0b002ee193437ca8
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr06de94
https://www.govinfo.gov/app/details/FR-1994-12-06
https://www.govinfo.gov/content/pkg/FR-1994-12-06/pdf/FR-1994-12-06.pdf
fdlp
62551
62968
DGPO
2017-01-09
2023-05-07
FR-1994-12-06
machine generated
eng
FR
FR-1994-12-06
59
233
true