Requirements of the Licensee

(A) Licensee Qualifications. A licensee is qualified to operate a mammography facility if he or she: (1) Is the owner of the mammography facility, and (2) Has demonstrated that the facility meets all applicable requirements of 105 CMR 127.000, and (3) Has demonstrated to the satisfaction of the Department that he or she is responsible and suitable to operate a mammography facility in compliance with applicable federal, state, and local laws and regulations. In determining whether an applicant is responsible and suitable to be granted a mammography facility license, the Department shall consider all relevant information including, but not limited to, the following: (a) The proposed licensee's history of statutory and regulatory compliance for mammography facilities in Massachusetts. Assessment of this factor shall include the ability and willingness of the proposed licensee to take corrective action when notified by the Department of any regulatory violations; (b) The proposed licensee's history of statutory and regulatory compliance for mammography facilities in other jurisdictions, including proceedings in which the proposed licensee was involved which resulted in or led to a limitation upon, suspension, revocation, or refusal to grant or renew a mammography facility license or certification for Medicaid or Medicare to the proposed licensee; and, (c) The history of criminal conduct of the proposed licensee and the mammography facility administrator, officers and directors as evidenced by criminal proceedings against those individuals which resulted in convictions, or guilty pleas, or pleas of nolo contendere, or admission of sufficient facts. (B) Licensee Duties. The licensee or applicant shall be responsible for insuring that: (1) The facility maintains adequate staffing to meet the health and safety needs of the patients including, but not be limited to: (a) A qualified Responsible Physician designated to be responsible for patient services and the overall operation of the facility; (b) A qualified Mammography Radiologic Technologist; (c) A qualified Medical Physicist; and (d) A qualified Interpreting Physician; each of whom meets the training and qualifications specified in 105 CMR 127.000. (2) No individual operates or allows to be operated a radiation machine for mammography unless the individual meets the standards established by the Department. Radiation machines for mammography are specifically designed to perform mammography. (4) The mammography facility allows inspection of its operation by the Department at any reasonable time and makes available to the Department at the time of inspection all records required pursuant to 105 CMR 127.000. A Quality Assurance Procedures Manual is developed and provided to all staff: Responsible and Interpreting Physicians, Mammography Radiologic Technologists and Medical Physicists. An annual review and updating of the Quality Assurance Procedures Manual is conducted and documented. (7) All required training documents are maintained at the facility or are reasonably accessible. (8) All mammographic x-ray machines are registered with the Radiation Control Program. (9) All mammographic x-ray equipment has been inspected and quality assurance tests are performed as required by 105 CMR 127.019(C). Current Department licenses and certificates are prominently posted in the mammography facility: mammography facility license, certificate of inspection, and Mammography Radiologic Technologist license(s). (11) Quality assurance test devices are provided at the facility. (a) Each facility shall maintain on-site quality assurance test devices referenced in 105 CMR 127.019(C)(1), (2) and (4). (b) The quality assurance test devices referenced in 105 CMR 127.019(C)(1) and (4) may be shared by and utilized at more than one facility.