Compilation of Rules and Regulations of the State of Georgia › Department 111 - RULES OF DEPARTMENT OF COMMUNITY HEALTH › Chapter 111-8 - HEALTHCARE FACILITY REGULATION › Subject 111-8-10 - LICENSURE OF CLINICAL LABORATORIES › Rule 111-8-10-.15 - Quality Control for Exfoliative Cytology; Histopathology; and oral Pathology

Current through Rules and Regulations filed through June 27, 2024
(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.