WILLIAM DONALD SCHAEFER, Governor Ch. 731
(VII) REQUIRE CYTOLOGY LABORATORIES TO REJECT
UNSATISFACTORILY PREPARED SPECIMENS, MAKE APPROPRIATE COMMENTS
REGARDING THE QUALITY OF THE SPECIMEN, AND MAINTAIN RECORDS ON
UNSATISFACTORILY PREPARED SPECIMENS FOR 5 YEARS SUBJECT TO REVIEW
BY THE DEPARTMENT;
(VIII) REQUIRE CYTOLOGY LABORATORIES TO
MAINTAIN AND STORE FOR 5 YEARS FROM THE DATE OF EXAMINATION ANY
SLIDE THAT WAS EXAMINED FOR DISEASE OR DISEASE AGENTS;
(IX) REQUIRE ALL CYTOLOGY REPORTS TO BE
RETAINED FOR AT LEAST 10 YEARS;
(X) PROHIBIT PHYSICIANS FROM SENDING PAP SMEAR
SPECIMENS TO OUT-OF-STATE LABORATORIES NOT LICENSED BY THE
DEPARTMENT; AND
(VI) (XI) ESTABLISH ANY ADDITIONAL STANDARDS
THE SECRETARY CONSIDERS NECESSARY TO ASSURE THAT MEDICAL
LABORATORIES ENGAGED IN CYTOPATHOLOGY CYTOLOGY PROVIDE SAFE AND
RELIABLE SERVICES TO THE CITIZENS OF THE STATE.
(2) THE REQUIREMENTS OF PARAGRAPH (1) OF THIS
SUBSECTION ARE IN ADDITION TO ANY OTHER RELEVANT PROVISION OF
THIS SUBTITLE OR RELEVANT REGULATION ADOPTED IN ACCORDANCE WITH
ANY OTHER PROVISION OF THIS SUBTITLE GOVERNING MEDICAL
LABORATORIES.
(D) (1) TO ASSURE COMPLIANCE WITH STANDARDS ADOPTED UNDER
SUBSECTION (C) OF THIS SECTION, THE SECRETARY SHALL ADOPT
REGULATIONS TO ESTABLISH AND CONDUCT A CYTOLOGY PROFICIENCY
TESTING PROGRAM FOR ALL CYTOLOGY PERSONNEL IN THE STATE THAT
EXAMINE CYTOLOGY SPECIMENS.
(2) THE PROFICIENCY TESTING PROGRAM SHALL REQUIRE
EACH MEDICAL LABORATORY ISSUED A PERMIT UNDER THE PROVISIONS OF
THIS SUBTITLE TO DEMONSTRATE SATISFACTORY PERFORMANCE IN
APPLICABLE LABORATORY PROCEDURES.
(3) (2) ALL CYTOLOGY PROFICIENCY TESTS CONDUCTED
UNDER THE STATE CYTOLOGY PROFICIENCY TESTING PROGRAM SHALL BE
HANDCARRIED, ON SITE AND UNANNOUNCED UNDER THE SUPERVISION OF AN
OFFICIAL OF THE LABORATORY LABORATORIES ADMINISTRATION OF THE
DEPARTMENT OF HEALTH AND MENTAL HYGIENE, OR AN ORGANIZATION
APPROVED BY THE SECRETARY.
(4) (3) THE SECRETARY SHALL ESTABLISH STANDARDS FOR
DEMONSTRATING SATISFACTORY PERFORMANCE IN THE A STATE CYTOLOGY
PROFICIENCY TESTING PROGRAM FOR MEDICAL LABORATORIES ALL CYTOLOGY
PERSONNEL IN THE STATE THAT WHO EXAMINE CYTOLOGY SPECIMENS.
- 4805 -
|