reglab/statecodes huggingface dataset:
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 127.000 - Licensing Of Mammography Facilities › Requirements › Section 127.015 - Physical Facility Requirements

Current through Register 1525, July 5, 2024
(A) Each
				mammography facility shall:
(1) Maintain its
				physical facilities in good repair in a safe, comfortable and sanitary
				state;
(2) Provide adequate space
				and equipment for reception and waiting areas, for administrative and staff
				offices, and for storage of patient records;
(3) Provide consultation, examination, and
				dressing areas appropriate to the services provided by the facility. Each
				facility shall furnish and arrange such areas in a manner that is consistent
				with their use and that safeguards the personal dignity and privacy (in terms
				of both sight and sound) of the patient during interview and
				examination;
(4) Provide
				conveniently located hand washing and toilet facilities adequate for patient
				and personnel, as appropriate to the services provided at the facility. A hand
				washing facility shall be immediately available and convenient to each
				examination area for staff use;
(5)
				Provide secure/locked location not accessible to unauthorized persons for
				storage of reports and records;
(6)
				Provide all rooms which do not have direct access to the outside, including
				toilets and utility areas, with satisfactory mechanical ventilation;
(7) Be accessible to individuals with
				disabilities and comply with applicable federal, state, and local requirements
				for accessibility;
(8) Maintain
				supplies and equipment appropriate in quantity and type to the specific
				services which the facility offers its patients;
(9) Keep supplies and equipment safe,
				sanitary and in good working condition as necessary for the services offered by
				the facility;
(10) Disinfect
				diagnostic and therapeutic equipment after each use in accordance with
				recognized standards of practice;
(11) Establish and enforce a preventative
				maintenance program to ensure all equipment is in safe working order. A
				maintenance check shall be regularly performed on all mechanical and electronic
				medical equipment. Electrified equipment shall be properly grounded and
				calibrated consistent with manufacturer's recommendations; and
(12) Develop and maintain a written fire
				safety plan and make a copy of this plan available to all staff
				members.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 127.000 - Licensing Of Mammography Facilities › Requirements › Section 127.016 - Optimum Exposure Ranges

Current through Register 1525, July 5, 2024
For mammographic examination of a 4.5 centimeter (cm) thick,
				  compressed breast, consisting of 50% glandular and 50% adipose tissue, the
				  average glandular dose shall be no more than 3mGy as measured using mammography
				  phantom accepted by the U.S. Food and Drug Administration.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 127.000 - Licensing Of Mammography Facilities › Requirements › Section 127.017 - Equipment Standards

Current through Register 1525, July 5, 2024
(A) Initial
				optimization of operating parameters shall be performed on all equipment used
				in producing mammograms. The process undertaken to perform the optimization and
				the results shall be documented.
(B) The image acquisition and image receptor
				systems and their individual components shall be specifically designed for
				digital mammography.
(C) The x-ray
				system must have the capability of providing kilovolt peak (kVp)/target/filter
				combinations appropriate to image receptor systems meeting the requirements of
				105 CMR 127.017(B).
(D) The x-ray
				machine shall be equipped with the following:
(1) a means of immobilizing and compressing
				the breast so that a constant force of a minimum of 25 to a maximum of 45
				pounds is achievable; and
(2) a
				means of maintaining this compression throughout the period of
				exposure.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 127.000 - Licensing Of Mammography Facilities › Requirements › Section 127.018 - Quality Assurance Program

Current through Register 1525, July 5, 2024
(A)
General Provisions
. The quality assurance program must
				include the following:
(1) The Responsible
				Physician of each facility in which mammographic x-ray procedures are performed
				shall establish and maintain an ongoing quality assurance program specific to
				mammographic imaging, covering all components of the mammography facility, to
				ensure consistently high-quality images with minimum patient
				exposure.
(2) The Responsible
				Physician shall conduct a review, at least annually, of the effectiveness of
				the quality assurance program and maintain a written report of such review. The
				most recent copy of such reports shall be available for inspection by
				Department inspectors at the machine use location.
(3) The Medical Physicist has the
				responsibility for establishing and conducting the ongoing equipment quality
				assurance program, as specified in
				105 CMR
				127.019(C), including:
(a) Conducting the initial setup optimization
				procedures on all the equipment used in producing mammograms prior to use on
				patients;
(b) Conducting or
				training others to conduct equipment performance monitoring
				functions;
(c) Conducting or
				training others to perform the analysis of the monitoring results to determine
				if there are problems requiring correction; and
(d) Carrying out or arranging for the
				necessary corrective actions, prior to continuing mammographic operations, when
				quality assurance test results indicate the need.
(4) The Medical Physicist shall routinely
				perform the equipment quality assurance measurements, when equipment is
				initially installed, after major changes or replacement of parts, and according
				to the frequency specified in
				105 CMR
				127.019.
(5) The licensee is responsible for ensuring
				that the mammographic x-ray equipment under his or her jurisdiction has been
				inspected and that quality assurance tests are performed by an individual as
				indicated:
(a) Quality assurance tests
				outlined in
				105 CMR 127.019(C)
				 may be performed by a Medical
				Physicist;
(b) Quality assurance
				tests outlined in
				105 CMR 127.019(C)(1)
				through (4) and (10) may be performed by a
				licensed Mammography Radiologic Technologist.
(6) Any individual who performs the quality
				assurance tests required in
				105 CMR 127.019(C)
				 shall verify in writing that the
				mammographic x-ray equipment is in safe operating condition, and is being
				operated at optimum performance criteria to yield the optimal quality mammogram
				that is adequate for clinical requirements:
(a) Prior to initial use of the equipment;
				and
(b) At least yearly after the
				initial verification.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 127.000 - Licensing Of Mammography Facilities › Requirements › Section 127.019 - Equipment Quality Assurance

Current through Register 1525, July 5, 2024
(A)
Quality Assurance Records for Mammography X-ray
				Equipment
.
(1) Records of all
				quality assurance tests shall be maintained for mammographic x-ray equipment
				and shall include at least the following:
(a)
				The mammographic x-ray equipment performance evaluation and optimization,
				including initial acceptance testing (to be completed before patients are
				exposed with the machine) and subsequent evaluations and testing;
(b) Verification that mammographic x-ray
				equipment is in safe operating order;
(c) Subsequent quality assurance test
				results;
(d) Notes regarding
				changes in operating conditions shall be recorded on the appropriate control
				charts;
(e) Operating levels and
				control limits for all quality assurance tests shall be indicated on the
				appropriate control chart;
(f) All
				records shall bear the date the procedure was done and the initials or name of
				the individual performing the test;
(g) Quality assurance tests on the
				Radiologist workstation monitors shall be done in accordance with
				manufacturer's requirements;
(h)
				Quality assurance tests on laser hardcopy printers shall be done in accordance
				with manufacturer's requirements.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 127.000 - Licensing Of Mammography Facilities › Requirements › Section 127.020 - Clinical Quality Assurance/Recordkeeping

Current through Register 1525, July 5, 2024
(A)
Responsible Physician
				Reports
: The Responsible Physician, or his or her designee, shall
				maintain a recordkeeping system for each patient, with a record of the
				mammography services the facility provides, including:
(1) The date the mammography procedure was
				performed;
(2) The name, address,
				and date of birth of the patient;
(3) A description of the procedures
				performed;
(4) The name and
				business address of the referring physician or other person to whom
				mammogram(s) (images) are loaned or otherwise transferred on a temporary basis;
				the date the mammograms are sent; and the date the mammograms are expected to
				be retrieved by the mammography facility.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 127.000 - Licensing Of Mammography Facilities › Requirements › Section 127.021 - Patient Protection

Current through Register 1525, July 5, 2024
(A)
Rights of Patients
.
(1) Each mammography facility shall protect
				patients' rights and shall develop a patients' rights statement ensuring that
				each patient shall:
(a) Be treated with
				dignity and respect;
(b) Be
				informed, at the time of scheduling the appointment, that the patient should
				either arrange for the patient's most recent prior mammogram (images) to be
				sent to the facility before the appointment, or bring it to the facility at the
				time of the appointment;
(c) Not be
				denied service or otherwise discriminated against solely because the patient is
				self-referred;
(d) Be provided with
				an opportunity, upon request, to discuss any radiation safety concerns with the
				Responsible Physician and/or the Mammography Radiologic Technologist before
				undergoing a mammography examination at the facility;
(e) Be informed, upon request, of the
				proposed or actual glandular dose of radiation;
(f) Receive a written statement describing
				the test results and, if results suggest other than routine mammographic
				follow-up, the next steps for the patient to pursue promptly after undergoing a
				mammogram at the facility;
(g) Be
				informed of the patient's right to discuss the results of the mammogram with
				the Responsible or Interpreting Physician;
(h) Be entitled to inspect and copy the
				patient's medical record, upon request, during normal business hours at the
				facility;
(i) Be entitled, upon
				request, to receive the images; and
(j) Be provided with the name and address and
				telephone number of the Radiation Control Program as the agency to which
				complaints can be made.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 127.000 - Licensing Of Mammography Facilities › Licensure › Section 127.022 - Licensure

Current through Register 1525, July 5, 2024
(A) No person shall maintain or operate a
				mammography facility unless he or she is the holder of a valid license granted
				by the Department.
(B) The
				Department shall issue two types of licenses to operate mammography facilities
				in the Commonwealth. The types of licenses shall be known as "Full" and
				"Provisional."
(1) Full License:
(a) A full license shall be issued to any
				facility that has been determined to meet all of the requirements of
				105 CMR
				127.000.
(b) A full license is valid for a period not
				to exceed 12 months.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 127.000 - Licensing Of Mammography Facilities › Licensure › Section 127.023 - Application for a License

Current through Register 1525, July 5, 2024
Mammography facilities shall apply for a license to operate
				  the facility issued pursuant to M.G.L. c. 111 § 5Q.
(A) Applications for licensure shall be made
				on forms prescribed by and available from the Department. Each applicant shall
				submit all the information required by the form and the accompanying
				instructions. The term "application" as used herein shall include original and
				renewal applications.
(B) The
				applicant shall provide at least the following information in order to be
				issued a license to operate a mammography facility:
(1) Name, address and telephone number of the
				following:
(a) The mammography facility;
				and,
(b) The prospective licensee
				of the mammography facility, including a statement of ownership of the facility
				that discloses the name and addresses of all owners or in the case of a
				corporation, the officers;
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 127.000 - Licensing Of Mammography Facilities › Licensure › Section 127.024 - Application for Renewal of a License

Current through Register 1525, July 5, 2024
(A)
				An applicant for license renewal must submit completed application forms and a
				check payable to the Commonwealth of Massachusetts to the Department no later
				than 60 days prior to the expiration of the current license, whereupon the
				licensee's existing license shall not expire until the renewal application
				status has been finally determined by the Department. The fee for a license
				renewal is specified in
				801 CMR
				4.00:
Rates.
(B) A license to operate a mammography
				facility shall not be renewed if there are any outstanding civil penalties
				issued pursuant to M.G.L. c. 111, § 50 and
				105 CMR
				127.000.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 127.000 - Licensing Of Mammography Facilities › Licensure › Section 127.025 - Acceptance of Application

Current through Register 1525, July 5, 2024
The Department shall not accept an application for an
				  original or renewal license unless:
(A) The application includes all information
				required by the Department;
(B) The
				application and all required attachments and statements submitted by the
				applicant meet the requirements of
				105 CMR
				127.000; and,
(C) The applicant has paid all required
				fees.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 127.000 - Licensing Of Mammography Facilities › Licensure › Section 127.026 - Processing of Applications

Current through Register 1525, July 5, 2024
(A) The Department
				will process applications for original licensure upon receipt of the completed
				forms and fees required. A license shall be issued to those applicants meeting
				all the requirements of
				105 CMR
				127.000.
(B) The Department will process renewal
				licenses upon receipt of the applicant's submission of completed forms. A
				renewal application shall be submitted at least 60 days prior to expiration. In
				the event that the Department is unable to act on a timely submitted renewal
				application prior to license expiration, the mammography facility may continue
				to operate until the Department takes action on the application. If, however,
				an application for renewal is not submitted within 60 days of expiration of the
				current license, then the license shall automatically expire and the
				mammography facility may not continue to operate without written permission by
				the Department.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 127.000 - Licensing Of Mammography Facilities › Licensure › Section 127.028 - Change of Name, Ownership or Location

Current through Register 1525, July 5, 2024
(A)
				The licensee shall notify the Department immediately, and in writing, of any
				proposed change in location, name or ownership of the mammography
				facility.
(B) A licensee who
				intends to change the location of a mammography facility shall submit a
				completed application for licensure at the new site at least 30 days prior to
				the intended date of relocation.
(C) Within 48 hours of a change in ownership,
				the new owner(s) of the mammography facility shall file an application for
				licensure. This application shall have the effect of a provisional license
				until such time as the Department acts upon the application.
(D) In the case of the transfer of ownership
				of a mammography facility, the application of the new owner for a license shall
				not have the effect of a provisional license when the application is not filed
				within 48 hours of a change of ownership or is not in accordance with
				105 CMR
				127.023.
(E) Any notice of hearing, order or decision
				which the Department or the Commissioner issues for a mammography facility
				prior to a transfer of ownership shall be effective against the former owner
				prior to such transfer and, where appropriate, the new owner, following such
				transfer unless said notice, order or decision is modified or dismissed by the
				Department or by the Commissioner.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 127.000 - Licensing Of Mammography Facilities › Licensure › Section 127.029 - Collection and Updating of Information

Current through Register 1525, July 5, 2024
(A) Each
				mammography facility shall file with the Department such data, statistics,
				schedules or information as the Department may require for the purposes of
				licensing and/or monitoring and evaluating the facility.
(B) All information submitted under the
				requirements of
				105 CMR
				127.000 or otherwise required by the Department shall
				be kept current by each licensee. Any document which amends, supplements,
				updates or otherwise alters a required document must be filed with the
				Department within 30 days of the change.
(C) Ownership and control information
				submitted under the requirements of
				105 CMR
				127.000 or otherwise required by the Department shall
				be kept current by each licensee. Any document which amends, supplements,
				updates or otherwise alters any ownership and control document required to be
				filed shall be filed with the Department within 30 days of the execution
				thereof.
(D) The licensee shall
				notify the Department in writing immediately but in any event no later than
				within 30 days of the initiation of any legal or disciplinary action or
				proceeding against the licensee or any person employed by the facility by any
				other licensing jurisdiction (State, United States or foreign), any health care
				institution, any professional society or association, any government agency,
				any law enforcement agency or any court for acts or conduct which would
				constitute grounds for suspension, denial, modification, limitation, revocation
				or refusal to renew a license under
				105 CMR
				127.000,
see
105
				CMR 127.035 or
				127.036(A),
				or which would in any way relate directly or indirectly to his or her fitness
				to be licensed under
				105 CMR
				127.000, to the care of patients at the facility, or
				to the continued operation of the facility.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 127.000 - Licensing Of Mammography Facilities › Inspection › Section 127.030 - Inspection

Current through Register 1525, July 5, 2024
(A) Authorized personnel of the Department
				shall be permitted to inspect mammography facilities at any reasonable time
				without prior notice. All parts of the mammography facility, all staff, all
				activities, all equipment, all supplies and all records are subject to
				inspection.
(B) The Department
				shall inspect each mammography facility annually.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 127.000 - Licensing Of Mammography Facilities › Inspection › Section 127.031 - Reports to the Board of Registration in Medicine

Current through Register 1525, July 5, 2024
Whenever the Department finds that a physician is practicing
				  in violation of the requirements of M.G.L. c. 112 § 5 and
				  243 CMR
				  2.07(24):
Standards
				  for Reading and Interpreting Mammography
regarding the reading and/or
				  interpretation of mammography, the Department shall forthwith provide written
				  notification to the Board of Registration in Medicine. In the case where the
				  Interpreting Physician is practicing out of the State, this notification shall
				  be made to the appropriate agency within the state in which the physician is
				  licensed.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 127.000 - Licensing Of Mammography Facilities › Inspection › Section 127.032 - Certificate of Inspection

Current through Register 1525, July 5, 2024
(A) No person shall
				operate a mammography facility unless licensed to do so and unless a
				certificate of inspection has been issued by the Department.
(B) Prior to issuing or renewing a license,
				the Department shall inspect each mammography facility for which application is
				made.
(C) A certificate of
				inspection shall be issued by the Department only if the mammography facility
				is found to be in substantial compliance with
				105 CMR
				127.000.
(D) No certificate of inspection shall
				continue in force after the expiration of the license under which it is
				issued.
(E) No certificate of
				inspection shall continue in force after the Department has suspended, revoked
				or refused to renew the license under which it is issued.
(F) No certificate of inspection shall be
				valid for any building premise other than for those for which the certificate
				was originally issued.
(G) Each
				licensee issued a certificate of inspection by the Department shall display the
				certificate on or near the mammography unit in full public view.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 127.000 - Licensing Of Mammography Facilities › Inspection › Section 127.033 - Complaints

Current through Register 1525, July 5, 2024
The Department shall investigate every complaint received
				  about practices or acts which may violate M.G.L. c. 111, §§ 5N
				  through 5Q or any provision of
				  105 CMR
				  127.000.
(A)
				If the Department finds that an investigation is not required because the
				alleged act or practice is not in violation of M.G.L. c. 111, §§ 5N
				through 5Q or
				105 CMR
				127.000, the Department shall notify the complainant
				of this finding and the reasons on which it is based.
(B) If the Department finds that an
				investigation is required, because the alleged act or practice may be in
				violation of M.G.L. c. 111, §§ 5N through 5Q or
				105 CMR
				127.000, the Department shall investigate and if a
				finding is made that the act or practice is in violation of M.G.L. c. 111,
				§§ 5N through 5Q or
				105 CMR
				127.000, then the Department may apply whichever
				enforcement procedure as provided in
				105 CMR
				127.000 is appropriate to remedying the situation and
				the Department shall notify the complainant of its action in this
				matter.
(C) Investigation of
				complaints may lead to enforcement actions including an order to cease an
				activity; denial, revocation, suspension or refusal to renew a license
				registration or certificate; modification or limitation of a license by the
				Department; and/or imposition of civil or criminal penalties.
(D) All oral or written complaints about
				mammography facilities shall be addressed to the Complaint Specialist,
				Radiation Control Program.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 127.000 - Licensing Of Mammography Facilities › Inspection › Section 127.034 - Availability of Reports; Disclosure of Information

Current through Register 1525, July 5, 2024
(A)
Disclosure of Information
				While Investigation Is Pending
. Upon request by any person, the
				Department shall provide the following information about a complaint pending
				investigation.
(1) The date on which
				Department staff received the complaint;
(2) The estimated date on which the
				Department expects to complete its investigation and issue the final complaint
				investigation report; and,
(3)
				Information about any actions taken by the Department to protect and ensure the
				health and safety of patients, employees or the public.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 127.000 - Licensing Of Mammography Facilities › Enforcement › Section 127.035 - Grounds for Suspension of a License or Immediate Cessation of Activity

Current through Register 1525, July 5, 2024
In accordance with M.G.L. c. 111, § 50, the Commissioner
				  may summarily suspend a license or order immediate cessation of an activity,
				  pending a hearing, whenever the Commissioner finds that public health, safety
				  or the environment would be threatened by delay in issuance of an order. A
				  mammography facility may not operate during the period of a suspension of its
				  license or conduct a prohibited activity after notification of an order of
				  immediate cessation of said activity.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 127.000 - Licensing Of Mammography Facilities › Enforcement › Section 127.037 - Enforcement Procedures

Current through Register 1525, July 5, 2024
(A)
Notice of Violation
. Whenever the Department finds
				upon inspection, investigation of a complaint or through information in its
				possession that an applicant or licensee is not in compliance with provisions
				of M.G.L. c. 111, §§ 5N through 5Q or a regulation promulgated
				thereunder, the Department shall notify the applicant or licensee of such
				violation or deficiency. The notice shall include a statement of the violations
				or deficiencies found, the provision of the law relied upon, and a reasonable
				period of time for correction. A violation or deficiency may result in denial,
				suspension, revocation or refusal to renew a license or certificate of
				inspection; a modification or limitation of a license; a cease and desist
				order; and/or the imposition of a civil penalty and/or criminal
				sanctions.
(B)
Plan of
				Correction
.
(1) The applicant or
				licensee shall within ten days of receipt of the notice, file with the
				Department a written plan of correction. The plan shall clearly identify the
				licensee, state the date, reference the violation or deficiency cited, state
				specific corrective action(s) and timetable(s) and date(s) for completion for
				each deficiency cited, and shall be signed by either the applicant or licensee
				or his or her designee.
(2) The
				Department may reinspect a facility in order to determine whether the
				corrections have been made. If upon review of plan of correction and/or
				reinspection the Department finds that the applicant or licensee is in
				compliance with
				105 CMR
				127.000 and/or that the applicant or licensee has
				submitted an acceptable plan of correction, the Department shall notify the
				applicant or licensee of its findings of compliance and/or its acceptance or
				modification of the plan of correction.
(3) If upon review of plan of correction
				and/or reinspection the Department finds the plan of correction is
				unacceptable, the Department may request that the applicant or licensee amend
				and resubmit the plan of correction with five days of the date of notice or
				such other time as the Department may specify for resubmission.
(4) If upon review of the plan of correction
				and/or reinspection the Department determines that an applicant or licensee
				remains noncompliant with applicable laws and regulations regarding licensure,
				the Department may initiate enforcement procedures as set forth in 105 CMR
				128.037(C).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 127.000 - Licensing Of Mammography Facilities › Enforcement › Section 127.038 - Severability

Current through Register 1525, July 5, 2024
The provisions of
				  105 CMR
				  127.000 are severable. If any section, subsection,
				  paragraph or provision is declared unconstitutional or invalid by a court of
				  competent jurisdiction, the validity of the remaining provisions shall not be
				  so affected.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 130.000 - Hospital Licensure › Section 130.010 - Scope

Current through Register 1525, July 5, 2024
105 CMR 130.000 applies to
				every hospital subject to licensure under M.G.L. c. 111, §§ 51
				through 56, except as stated in
				105 CMR
				130.000.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 130.000 - Hospital Licensure › Section 130.050 - Waiver of Requirements Imposed on Hospitals

Current through Register 1525, July 5, 2024
The Commissioner may waive the applicability to a particular
				hospital of one of more of the requirements imposed by
				105 CMR
				130.000 upon finding that:
(A) Compliance would cause undue hardship to
			 the hospital;
(B) The hospital's
			 non-compliance does not jeopardize the health or safety of its patients and
			 does not limit the hospital's capacity to give adequate care;
(C) The hospital has instituted compensating
			 features that are acceptable to the Commissioner; and
(D) The hospital provides to the Commissioner
			 written documentation supporting its request for a waiver.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 130.000 - Hospital Licensure › Section 130.051 - Special Projects

Current through Register 1525, July 5, 2024
The Department will consider proposals for special projects for
				the innovative delivery of hospital services. No such proposal shall be
				implemented without prior written approval of the Department. The Department
				may impose conditions on special projects as necessary.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 130.000 - Hospital Licensure › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Section 130.100 - Requirement of License

Current through Register 1525, July 5, 2024
Every hospital shall obtain a hospital license from the
				  Department for all premises under its control at which clinical services are
				  provided.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 130.000 - Hospital Licensure › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Section 130.101 - Application for License

Current through Register 1525, July 5, 2024
(A) Applicants must
				submit license applications or for renewal of such license on a form provided
				by the Department and accompanied by all supporting documents required by
				105 CMR
				130.000. Applications for initial licensure shall be
				submitted at least 60 days prior to the anticipated provision of clinical
				services.
(B) In addition to the
				above requirement hospitals seeking deemed status under
				105 CMR
				130.000 shall file a consent form provided by the
				Department concerning release of information under
				105 CMR
				130.202.
(C) The applicant must include the hospital
				license fee.
(D) If the application
				is for an acute-care hospital resulting from a transfer of ownership, the
				applicant must submit:
(1) information on all
				financial transactions related to the transfer, including remuneration of all
				officers of hospitals affected by the transaction; and
(2) if the transferor is a non-profit entity,
				an attestation that the hospital's governing board publicly presented and
				evaluated all proposals for the merger or acquisition that resulted in the
				proposed transfer.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 130.000 - Hospital Licensure › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Section 130.102 - Local Approvals

Current through Register 1525, July 5, 2024
The applicant shall furnish an inspection certificate issued
				  by the Department of Public Safety, Division of Inspection and a certificate of
				  inspection issued by the head of the local fire department in support of each
				  application for licensure.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 130.000 - Hospital Licensure › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Section 130.103 - Incidents of Ownership

Current through Register 1525, July 5, 2024
(A) Each hospital
				shall be designated by a permanent and distinctive name, which shall appear on
				the application for a license and which shall not be changed without prior
				notification to the Department. The name of the hospital shall not tend in any
				way to mislead the public as to the type or extent of care provided by the
				facility.
(B) The Department may
				request a hospital to submit in support of its application for an original
				license, or upon any change of ownership such additional information concerning
				ownership and control as the Department may require.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 130.000 - Hospital Licensure › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Section 130.104 - Evidence of Responsibility and Suitability

Current through Register 1525, July 5, 2024
(A) In determining whether an applicant for a
				license for an acute-care hospital is responsible and suitable to be granted a
				hospital license, the Department shall consider all relevant information
				including, but not limited to, the following:
(1) The applicant's history in providing
				acute care, including in states other than Massachusetts, if any, measured by
				compliance with the applicable statutes and regulations governing the operation
				of hospitals in such states. Assessment of this factor shall include the
				ability and willingness of the applicant to take corrective action when
				notified by the Department of regulatoryviolations and anyproceedings in which
				the applicant was involved that proposed or led to a limitation upon or a
				suspension, revocation, or refusal to grant or renew a health care facility
				license or certification for Medicaid or Medicare to the applicant;
(2) The applicant's financial capacity to
				provide acute care in compliance with state law and
				105 CMR
				130.000 as evidenced by sufficiency of present
				resources and assessment of past history, including financial involvement with
				health care facilities that have filed petitions for bankruptcy;
(3) The history of criminal conduct of the
				applicant, and of the chief executive officer and chief financial officer of
				the applicant, as evidenced by criminal proceedings against those individuals
				or against health care facilities in which those individuals either owned
				shares of stock or served as corporate officers, and which resulted in
				convictions, or guilty pleas, or pleas of
nolo contendere
, or
				admissions of sufficient facts;
(4)
				The participation of persons residing in the hospital's primary service area in
				oversight of the resulting hospital if the applicant is a non-profit entity;
				and
(5) Whether the transaction
				will create a significant effect on the availability or accessibility of health
				care services to the communities served by the hospital.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 130.000 - Hospital Licensure › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Section 130.105 - Updating of Information

Current through Register 1525, July 5, 2024
All information required by the Department under
				  105 CMR
				  130.101 and
				  130.103
				  shall be kept current by each hospital. Changes in this information shall be
				  reported to the Commissioner within 30 calendar days of
				  occurrence.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 130.000 - Hospital Licensure › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Section 130.107 - Submission and Approval of Architectural Plans and Specifications

Current through Register 1525, July 5, 2024
In the case of new construction of a hospital, or alterations
				  or additions to an existing hospital, the hospital must submit preliminary
				  architectural plans and final architectural plans and specifications for
				  written approval prior to commencing said new construction or alterations or
				  additions. The Department shall establish standards for review and approval of
				  plans as administrative guidelines, based on the Facility Guidelines
				  Institute's Guidelines applicable to design and construction of hospitals and
				  outpatient health care facilities.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 130.000 - Hospital Licensure › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Section 130.108 - Condition of Licensure

Current through Register 1525, July 5, 2024
(A) Each hospital
				shall participate in risk management programs as required under M.G.L. c. 111,
				§ 203(d).
(B) Applicants for a
				license for an acute-care hospital must submit a plan, to be approved by the
				Department, for the provision of community benefits, including the
				identification and provision of essential health services. In approving the
				plan, the Department may take into account the applicant's existing commitment
				to primary and preventive health care services and community contributions as
				well as the primary and preventive health care services and community
				contributions of any predecessor hospital. The Department may waive this
				requirement, in whole or in part, at the request of the applicant which has
				provided or at the time the application is filed, is providing substantial
				primary and preventive health care services and community contributions in its
				service area. The Department may consider a hospital's community benefits plan
				that is filed with the Attorney General's office or with the Department in
				compliance with the Determination of Need program and has been made public, to
				meet the requirements of 130 CMR 130.108.
(C) Each hospital shall comply with all
				applicable state and federal statutes and regulations pertaining to health care
				facilities.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 130.000 - Hospital Licensure › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Section 130.109 - Transfer of Ownership or Location

Current through Register 1525, July 5, 2024
(A) To
				transfer ownership or location, a hospital must comply with any additional
				procedures set forth in
				105 CMR
				100.000:
Determination of
				Need
.
(B) A licensed
				hospital must notify the Department immediately in writing of any proposed
				change in name or location of a facility. A license shall not be transferred
				from one person or entity to another or from one location to another.
(C) The proposed licensee shall submit a
				Notice of Intent to acquire a hospital to the Department at least 90 calendar
				days in advance of any transfer of ownership.
(1) If the hospital is an acute-care
				hospital, the Department shall schedule a public hearing on the proposed
				transfer of ownership.
(2) If the
				transfer of ownership will follow the merger or acquisition of the hospital,
				the board of trustees of the hospital must publicly present and evaluate all
				proposals for such a merger or acquisition.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 130.000 - Hospital Licensure › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Section 130.110 - Issuance of License

Current through Register 1525, July 5, 2024
(A) The Department
				shall issue a hospital license to any applicant that meets all of the
				applicable requirements of
				105 CMR
				130.000. Every license shall state the name and
				address of the hospital if either differs from that of the licensee; the period
				of licensure; the specific service(s) for which the hospital is licensed; and
				the name and address of any satellite unit for which the Department has
				authorized coverage by the hospital license.
(B) Except for units licensed prior to April
				21, 1988 no hospital shall provide long-term care services under a license
				issued pursuant to M.G.L. c. 111, § 51 through 56 but shall seek licensure
				under M.G.L. c. 111, § 71.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 130.000 - Hospital Licensure › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Section 130.111 - Right to Visit and Inspect

Current through Register 1525, July 5, 2024
The Department or its agents may visit a hospital subject to
				  licensure under M.G.L. c. 111, § 51, and any satellite unit of the
				  hospital, at any time without prior notice and inspect it, its staff,
				  activities, and records to determine the hospital's compliance with state law
				  and
				  105 CMR
				  130.000.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 130.000 - Hospital Licensure › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Section 130.112 - Deficiency Statements

Current through Register 1525, July 5, 2024
After every Department inspection in which any violation of
				  105 CMR
				  130.000 is observed, the Commissioner or his or her
				  designee shall prepare a deficiency statement citing every violation observed,
				  a copy of which shall be sent to the hospital.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 130.000 - Hospital Licensure › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Section 130.113 - Plans of Correction

Current through Register 1525, July 5, 2024
A hospital shall submit to the Department a written plan of
				  correction of violations cited in a deficiency statement prepared pursuant to
				  105 CMR
				  130.111 within ten calendar days after the
				  deficiency statement is sent. Every plan of correction shall set forth, with
				  respect to each deficiency, the specific corrective step(s) to be taken, a
				  timetable for such steps, and the date by which compliance with
				  105 CMR
				  130.000 will be achieved. The timetable and the
				  compliance dates shall be consistent with achievement of compliance in the most
				  expeditious manner possible. A plan of correction that does not meet the
				  requirements of
				  105 CMR
				  130.112 shall be considered unacceptable by
				  the Department and returned to the hospital.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 130.000 - Hospital Licensure › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Section 130.121 - Licensed Bed Capacity

Current through Register 1525, July 5, 2024
(A) Each license
				shall specify the total number of beds within the hospital and the number of
				beds in each specific service for which the hospital is licensed.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 130.000 - Hospital Licensure › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Section 130.122 - Beds Out of Service and Discontinuation of Service

Current through Register 1525, July 5, 2024
(A) A hospital may remove beds from service
				temporarily, within the discretion of the licensee, except that any hospital
				that intends to remove beds from service for more than six months shall notify
				the Department in writing at least 30 days prior to such removal.
(B) Nothing in 105 CMR 130.122 shall be
				construed to authorize a licensee to discontinue any service, as defined in
				105 CMR 130.020 to
				the public entirely or in substantial part except upon notice to the Department
				as described in 105 CMR 130.122. Notice to the Department shall be given at
				least 90 calendar days in advance of the planned closure of the service:
At least 30 days prior to notifying the Department of the
				  proposed closure of an essential health service, the hospital shall inform
				  either electronically or in writing the Department and the following parties of
				  its intent to submit notice to close a service:
(1) The hospital's patient and family
				council;
(2) Each staff member of
				the hospital;
(3) Every labor
				organization that represents the hospital's workforce during the period of the
				essential services closure;
(4) The
				members of the General Court who represent the city or town in which the
				hospital is located; and
(5) A
				representative of the local officials of the city or town in which the hospital
				is located.
With respect to the proposed closure of an essential health
				  service, the 90 day notice to the Department shall at a minimum provide current
				  utilization rates for service(s) being discontinued, describe the anticipated
				  impact on individuals in the hospital's service area, provide the date set for
				  discontinuation, include the names and addresses of any organized health care
				  coalitions and community groups that are known to the hospital when the notice
				  is issued to the Department, a detailed account of any community engagement and
				  planning which has occurred prior to such filing, and such other information as
				  the Commissioner may require. With respect to the proposed closure of an
				  essential health service, the hospital shall also send a copy of the notice
				  that it submits to the Department to the Health Policy Commission, Office of
				  the Attorney General, Center for Health Information and Analysis, and Executive
				  Office of Labor and Workforce Development as well as each of the health care
				  coalitions and community groups identified by the hospital in its notice to the
				  Department. The Commissioner or his or her designee may waive the 90-day time
				  frame for notifying the Department of a planned discontinuation of a service
				  only in extraordinary circumstances where the Commissioner has determined that
				  such a waiver is necessary to protect the health and safety of patients served
				  by the hospital.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 130.000 - Hospital Licensure › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Section 130.124 - Period of License

Current through Register 1525, July 5, 2024
(A) The Department
				shall issue a hospital license for a period of two years.
(B) Provided a licensed hospital submits a
				timely application for a renewal license, its previous license shall be valid
				until the Department acts on its renewal application.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 130.000 - Hospital Licensure › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Section 130.126 - Posting of License and DPS Certificate

Current through Register 1525, July 5, 2024
(A)
				The hospital shall conspicuously post the license on the hospital's premises
				and shall conspicuously post a copy of its license in each satellite unit of
				the hospital.
(B) The hospital
				shall conspicuously post its current inspection certificate issued by the
				Department of Public Safety.