1997 S Health - Consolidated Contract between The State of NC as Represented by the State Health Director

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Page 4 Con.&aet Addendum III. QUALITY ASSU ANC'E A. Cervical Screening_and follow-ua: Laboratories must be certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88). The Bethesda System is required for reporting the results of Pap smears. (See Pap Smear Screening- A Guide for Health Departmt ents, page 1-5). A report of all screening and follow-up results will be placed in the patient's medical record. B. Breast Screening and follow-=: Federal Food and Drug Administration (FDA) certification is required for all mammography facilities. When contracting with any mammography facility, the contractor will take into consideration that mammography facility's prior performance under the Mammography Quality Standards Act (MQSA) regulations. Reporting of results of mammograms from all contractors and all sub-contractors will be made on the Mammography and Billing Report supplied by the BCCCP which utilizes the American College of Radiology Breast Imaging Reporting and Database System, final categories for mammogram assessment (See Appendix VII, Breast Health: A Cmj& for Health Departments). Any substitute report form requires prior BCCCP approval. A report of all screening and follow-up results will be placed in the patient's medical record. C. Freauc= of Screenings- The frequency of screenings will follow the protocols noted in Section II.B. and II.C. of this Contract Addendum. D. Program Audits: s: The contractor will provide or assure the provision of high quality services for all the program components. Audits will be conducted by the BCCCP staff in order to evaluate the program components as specified in this Contract Addendum for the purposes of quality assurance. Prior notification will be given as to the date and time of the audit. W. DATA AND PROGRAM REPORTING A. Minimum Data Elements (MDEs)for every woman provided screening and follow-up services will be reported to the BCCCP in one of two ways: L Enter aFelectronically in the state HSIS (and the Enhanced System when available) or through a compatible system; or 2. Provided in hard copy if the HSIS is not available. B. All data will be entered or sent no later than the 15th of the month following the month the service was provided.