Quality Assurance

(A) For purposes of assuring the quality of submitted data, each physician and if applicable each health care facility and physician practice group that acts as a physician’s agent for reporting shall allow the Congenital Anomalies Registry to inspect and copy such parts of a patient’s medical records, paper and electronic, as are necessary to verify the accuracy and completeness of submitted data. (B) Each physician, and/or agent, shall provide to the Congenital Anomalies Registry for inspection and copying no more than is necessary for quality assurance purposes. In order to provide only those portions of the medical records that contain specific information required to be reported under 105 CMR 302.000, the physician, and/or agent, shall employ reasonable measures to delete, mask, cross out or otherwise render illegible other parts of the patient’s record. (C) Each copy of a medical record or part thereof obtained by the Congenital Anomalies Registry: (1) Shall be stored securely with restricted access when not being used by the Registry; and (2) Shall not be re-copied by the Registry; and (3) Shall be destroyed promptly following verification of the corresponding reported data, or if the reported data appears to be inaccurate, following clarification or correction of reported data.