Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 127.000 - Licensing Of Mammography Facilities
Requirements
Section 127.010 - Requirements of the Licensee
Universal Citation: 105 CMR 127.000 MA Code of Regs 127.010
Current through Register 1531, September 27, 2024
(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.
(3) 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.
(5) A
Quality Assurance Procedures Manual is developed and provided
to all staff: Responsible and Interpreting Physicians, Mammography Radiologic
Technologists and Medical Physicists.
(6) 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).
(10) 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.
Disclaimer: These regulations may not be the most recent version. Massachusetts may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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