19 CSR 25-33.010
Approval of Laboratories for the Performance of Serologic Tests for Human Immunodeficiency Virus Antibodies
PURPOSE: This rule establishes the procedures and requirements for laboratories performing serologic tests on serum or plasma
for detection of antibodies to Human Immunodeficiency Virus in order to be approved to
conduct HIV tests by the Department of
Health.
PUBLISHER’S NOTE: The secretary of state
has determined that the publication of the
entire text of the material which is incorporated by reference as a portion of this rule
would be unduly cumbersome or expensive.
Therefore, the material which is so incorporated is on file with the agency who filed this
rule, and with the Office of the Secretary of
State. Any interested person may view this
material at either agency’s headquarters or
the same will be made available at the Office
of the Secretary of State at a cost not to
exceed actual cost of copy reproduction. The
entire text of the rule is printed here. This
note refers only to the incorporated by reference material.
(1) The director of a laboratory seeking
Department of Health and Senior Services
(DHSS) approval to perform serologic tests
for detection of the Human Immunodeficiency Virus (HIV) antibodies shall make written
application on form Lab 125, which is incorporated by reference, to the director, State
Public Health Laboratory, DHSS.
(A) Hospitals licensed according to Chapter 197, RSMo shall be considered to be in
compliance with departmental rules governing serologic tests for detection of HIV antibodies.
(B) In addition to applying for approval,
the laboratory shall be in compliance with the
Clinical Laboratory Improvement Amendments of 1988 (CLIA 88). A copy of the currently valid CLIA certificate shall be initially
submitted to the director, State Public Health
Laboratory, DHSS to obtain DHSS approval.
(C) All laboratory testing shall be conducted at the address given when application for
the approval is made. Written notice of
change of address shall be given to DHSS
prior to actually moving the testing facilities.
(2) DHSS shall issue a certificate of approval
to a laboratory meeting the requirements of
this rule. The certificate is effective until
revoked.
(3) A certificate of approval may be revoked
when a participating laboratory discontinues
its testing services or fails to meet the
requirements of CLIA 88 which relate to
serologic testing for antibodies to HIV. Compliance will be monitored by Department of
Health and Senior Services, Bureau of Health
Facility Regulation, CLIA program.
AUTHORITY: sections 191.653 and 192.006,
RSMo 2000.* This rule was previously filed
as 19 CSR 20-33.010. Original rule filed Jan.
19, 1989, effective April 13, 1989. Rescinded
and readopted: Filed Jan. 15, 1993, effective
July 8, 1993. Changed to 19 CSR 25-33.010
Jan. 1, 1995. Amended: Filed Nov. 3, 2003,
effective April 30, 2004.
*Original authority: 191.653, RSMo 1988, amended 1996;
192.006, RSMo 1993, amended 1995.
Human Immunodeficiency Virus Antibodies