Rule 111-8-10-.15 - Quality Control for Exfoliative Cytology; Histopathology; and oral Pathology(1)Exfoliative Cytology.(a) The laboratory must establish and document an annual evaluation of the number of cytology cases examined, the number of specimens processed by type, the number of cases reported by diagnosis, including the number of cases reported as unsatisfactory for diagnosis, the number of gynecologic cases where cytology and available histology are discrepant, and the number of cases where histology results were unavailable for comparison. The evaluation must also include the number of gynecologic cases where the rescreen of a negative or normal test results in a reclassification to a premalignant or malignant diagnosis.(b) The laboratory must evaluate the case reviews of each person examining slides against the overall statistical values, document the reasons for deviations, and corrective actions taken, if needed.(c) The laboratory must develop and implement procedures to detect inadequately prepared slides, assuring no diagnosis is reported on such cases. Such procedures must include a plan for promptly notifying referring physicians of inadequately prepared slides. The report must clearly distinguish specimens, or smears, or both, that are unsatisfactory for diagnosis interpretation. Documentation of unsatisfactory specimens and notifications must be retained by the laboratory for a minimum of five years.(d) The laboratory director or supervisor qualified in cytology or cytotechnology shall rescreen for proper staining and correct interpretation at least a ten percent random sample of gynecological smears which have been interpreted to be in one of the benign categories by personnel not processing director or supervisor qualifications. The review must include negative cases selected at random from the total caseload and from patients or groups of patients that are identified as having a high probability of developing cervical cancer, based on available patient information. Records of initial examination and rescreening must be available. Rescreening must be performed prior to reporting.(e) No laboratory shall assign or permit an individual engaged in the evaluation of cytology preparations by non-automated microscopic technique to examine more than one hundred (one patient per slide, gynecologic or non-gynecologic, or both) slides in a twenty-four hour period. This limit represents an absolute maximum number of slides in any twenty-four hour period, unless slide preparations are made using automated, semiautomated, or other liquid-based slide preparatory techniques resulting in cell dispersion over one-half or less of the slide area, in which case the slide counts as one-half slide, if examined by nonautomated microscopic technique. The maximum number of one hundred slides shall be examined in not less than an eight-hour period. Recognizing individual differences in abilities, the laboratory must establish the maximum number of slides (not to exceed the 100 slide limit) each individual may screen in a twenty-four hour period, and records must be available to document that each individual's workload limit is reassessed at least every six months and adjusted, when necessary. For the purposes of establishing workload limits for individuals examining slides by nonautomated microscopic technique on other than an eight hour workday basis, a period of eight hours must be used to prorate the number of slides that may be examined by using the following formula: number of hours examining slides X 100 / 8
(f) Records shall be maintained by the laboratory of the total number of slides examined by cytotechnologist during each twenty-four and eight hour period. It shall be the responsibility of each laboratory to maintain records of the number of slides read on and off the premises of the laboratory by cytotechnologists when such slides are assigned by that laboratory. All slides must be read on the premises of the licensed laboratory unless referred to another licensed laboratory.(g) All gynecological smears interpreted to be in the "suspicious" or "positive" categories by cytotechnologists shall be confirmed by the laboratory director or supervisor, who is qualified in Exfoliative Cytology as specified in Rule 111-8-10-.06(1)(a)2. or (3)(b), and who shall personally sign all such suspicious or positive reports. All nongynecological cytological preparations, positive and negative, shall be reviewed by such a director or supervisor qualified in cytology. All slides for exfoliative cytology must be retained as long as required by applicable federal law and regulations, but not less than five years from the date of examination.(h) The laboratory must review, for each patient with premalignant or malignant gynecologic cytology results, all gynecologic cytology specimens received within the previous five years, if available. If significant discrepancies are found that would affect patient care, the laboratory must notify the patient's physician and issue an amended report.(2)Histopathology and Oral Pathology. Special stains on tissue sections must be checked for intended reactivity by use of positive preparations, and results of reactions must be documented. Stained slides and tissue blocks shall be retained as long as required by applicable federal law and regulations, but not less than ten years for slides or two years for tissue blocks. Remnants of tissue specimens shall be retained in a fixative solution until those portions submitted for microscopy have been examined and a diagnosis made by a pathologist.Ga. Comp. R. & Regs. R. 111-8-10-.15
O.C.G.A. § 31-22-1et seq.
Original Rule entitled "Quality Control for Exfoliative Cytology; Histopathology; and Oral Pathology" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.