Page:United States Statutes at Large Volume 102 Part 3.djvu/957

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PUBLIC LAW 100-000—MMMM. DD, 1988

PUBLIC LAW 100-578—OCT. 31, 1988

102 STAT. 2909

designed to assure consistent performance by laboratories of valid and reliable cytological services. "(B) STANDARDS.—The standards established under subparagraph (A) shall include— "(i) the maximum number of C3rtology slides that any individual may screen in a 24-hour period, "(ii) requirements that a clinical laboratory maintain Records. a record of (I) the number of cytology slides screened during each 24-hour period by each individual who examines cytology slides for the laboratory, and (II) the number of hours devoted during each 24-hour period to screening C3i;ology slides by such individual, "(iii) criteria for requiring rescreening of cytological preparations, such as (I) random rescreening of cytology specimens determined to be in the benign category, (II) focused rescreening of such preparations in high risk groups, and (III) for each abnormal cytological result, rescreening of all prior cytological specimens for the patient, if available, "(iv) periodic confirmation and evaluation of the proficiency of individuals involved in screening or interpreting cytological preparations, including announced and unannounced on-site proficiency testing of such individuals, with such testing to take place, to the extent practicable, under normal working conditions, "(v) procedures for detecting inadequately prepared slides, for assuring that no cytological diagnosis is rendered on such slides, and for notifying referring physicians of such slides, '(vi) requirements that all cytological screening be done on the premises of a laboratory that is certified under this section. "(vii) requirements for the retention of cytology slides by laboratories for such periods of time as the Secretary considers appropriate, and "(viii) standards requiring periodic inspection of C3rtology services by persons capable of evaluating the quality of cytology services.


"(1) IN GENERAL.—The Secretary may, on an announced or unannounced basis, enter and inspect, during regular hours of operation, laboratories which have been issued a certificate under this section. In conducting such inspections the Secretary shall have access to all facilities, equipment, materials, records, and information that the Secretary determines have a bearing on whether the laboratory is being operated in accordance with this section. As part of such an inspection the Secretary may copy any such material or require to it be submitted to the Secretary. An inspection under this paragraph may be made only upon presenting identification to the owner, operator, or agent in charge of the laboratory being inspected. "(2) COMPLIANCE WITH REQUIREMENTS AND STANDARDS.—The

Secretary shall conduct inspections of laboratories under paragraph (1) to determine their compliance with the requirements of subsection (d) and the standards issued under subsection (f). Inspections of laboratories not accredited under subsection (e) shall be conducted on a biennial basis or with such other