Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories
Section 180.420 - Standard - Exfoliative Cytology, Histopathology, Oral Pathology: Quality Control
Universal Citation: 105 MA Code of Regs 105.180
Current through Register 1531, September 27, 2024
(A) Exfoliative Cytology
(1) The Technical Supervisor or the Cytology
General Supervisor shall rescreen for proper staining and correct
interpretation at least a 10% random sample of gynecological smears which have
been interpreted to be in one of the benign categories.
(2) All gynecological and non- gyn smears
interpreted to be in the "suspicious" or positive categories by screeners shall
be confirmed and the report shall be signed by a physician qualified in
anatomic pathology or cytology.
(3)
All negative non-gynecological cytological preparations, shall be confirmed and
signed by the Technical Supervisor or Cytology General Supervisor.
(4) Automated methods shall provide quality
control similar to that provided in other automated laboratory
procedures.
(5) All smears shall be
retained for a minimum of seven years from date of examination.
(6) The Technical Supervisor for Cytology
shall spend time working in the laboratory in proportion to the volume of
cytology cases screened.
(7) A
quality control system shall be in place to assure and document the proficiency
of all levels of personnel responsible for screening smears.
(8) The Technical Supervisor for Cytology
shall be available at the laboratory site on a regular basis to review and
report on specimens and to review all components of the quality control
system.
(B) Histopathology and Oral Pathology
(1) All special stains shall be controlled
for intended reactivity by use of positive slides.
(2) Stained slides shall be retained for a
minimum of 7 years from date of examination. Blocks shall also be retained for
a minimum of 7 years from such date.
(3) Remnants of tissue specimens shall be
retained in a fixative solution until those portions submitted for microscopy
have been examined and the report has been signed by a physician qualified in
anatomic pathology or oral pathology.
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