Standard - Exfoliative Cytology, Histopathology, Oral Pathology: Quality Control
Effective Jul 9, 2004MGL c. 111 §§ 3, and 51 through 53 MGL c. 111DDepartment of Public Health
(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.