Standard - Exfoliative Cytology, Histopathology, Oral Pathology: Quality Control

(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.