reglab/statecodes huggingface dataset:
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 100.000 - Determination of Need › Section 100.445 - Public Hearing

Current through Register 1525, July 5, 2024
(A) The Commissioner
			 shall order a public hearing upon the written request made by any Party of
			 Record within 30 days following the Application's Filing Date pursuant to
			 105 CMR
			 100.435; and may, in his or her discretion,
			 order one or more public hearing(s) whenever, in his or her opinion, a public
			 hearing would aid the Department Staff in carrying out its duties pursuant to
			 105 CMR 100.000.
(B) The purpose of
			 a public hearing pursuant to
			 105 CMR 100.445
			 shall be to allow any Person to make their views known with respect to an
			 Application before the Department. Such public hearing shall not be
			 adjudicatory in nature, but shall be a public forum for the presentation of any
			 comment(s) that may be relevant to the consideration of an
			 Application.
(C) A public hearing
			 ordered by, or requested from, the Commissioner may be held at any time. If
			 feasible, every public hearing shall be held at a location in the Primary
			 Service Area of the Proposed Project. Department Staff, at least ten days
			 before any scheduled public hearing, shall provide notification of the time,
			 place, and nature of such hearing to each Party of Record and shall publish
			 notification of the hearing within the Primary Service Area of the Proposed
			 Project.
(D) A designated
			 representative of the Department shall conduct any public hearing pursuant to
			 105 CMR
			 100.445.
(E) The Commissioner may request a transcript
			 of the public hearing to be provided at the expense of the
			 Applicant.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 100.000 - Determination of Need › Section 100.510 - Staff Report and Written Comment Period

Current through Register 1525, July 5, 2024
(A) With
			 respect to each Application not withdrawn or dismissed, following the Filing
			 Date, Department Staff shall prepare a written Staff report to the Department
			 or Commissioner, as applicable. The Staff report, at a minimum, shall contain
			 the following:
(1) A description of the
			 Proposed Project with a summary of any significant supporting material(s) filed
			 by the Applicant;
(2) A summary of
			 all comments, testimony, and official statements properly received as public
			 information from both Parties of Record and the general public;
(3) A summary of any comments, information,
			 and rationale from Department Staff including, but not limited to, a summary of
			 the Application's ability to meet the requirements of each Factor pursuant to
			 105 CMR
			 100.210; and why
(4) Any additional information or analysis
			 Department Staff wish to bring to the Department's attention;
(5) A clear statement of Department Staffs
			 recommendation(s) or suggested options for Final or preliminary action upon the
			 Application by the Department; and
(6) For Staff reports recommending the
			 issuance of a Notice of Determination of Need, all applicable Standard
			 Conditions and any Other Conditions recommended for attachment as Conditions of
			 the Notice of Determination of Need.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 100.000 - Determination of Need › Section 100.545 - Prerequisites to Department Action

Current through Register 1525, July 5, 2024
Except in the case of an emergency Application made pursuant to
				105 CMR
				100.740, the Department shall not take
				preliminary or Final Action upon an Application, unless first:
(A) The Application or amendment has been on
			 file with the Department for at least 30 days following the Filing Date and the
			 Applicant has provided a copy to each Party of Record; and
(B) A public hearing has been held, if
			 directed by the Commissioner pursuant to
			 105 CMR
			 100.445.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 100.000 - Determination of Need › Section 100.555 - Postponement of Consideration of Application for Determination of Need

Current through Register 1525, July 5, 2024
Any Party of Record may request postponement of consideration
				of an Application for Determination of Need until the next meeting of the
				Department. Such request may be granted only if the Commissioner determines
				that the request is for good cause, that failure to grant the request will
				significantly prejudice the Party of Record making the request from having its
				position considered by the Department, and that postponement would not
				prejudice any other Party of Record. A request for postponement under
				105
				CMR 100.555 must be made in writing to the
				Commissioner with copies simultaneously provided to all Parties of Record at
				least seven days before the scheduled Department meeting, and must state the
				rationale for the request for postponement. A Party of Record may be granted a
				postponement only once.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 100.000 - Determination of Need › Section 100.615 - Final Action by the Department

Current through Register 1525, July 5, 2024
(A) With respect to
			 each Application for Determination of Need not withdrawn or dismissed,
			 following the Submission Date, the Department shall act upon each Application
			 by either disapproving an Application or by issuing a Notice of Determination
			 of Need, subject to any and all applicable terms and Conditions set forth
			 within 105 CMR 100.000, and based upon all written materials associated with a
			 Proposed Project by adopting, amending, or rejecting the findings and
			 recommendations, in whole or in part, within the Department staff report made
			 pursuant to
			 105 CMR
			 100.510.
(B) The Department shall approve or
			 disapprove, in whole or in part, each Application for a Determination of Need
			 within four months after the Filing Date, or the date of which a permissible
			 amendment to a pending Application was received by the Department; provided,
			 however, that the Department may, on one occasion only, delay the action for up
			 to two months after the Applicant has provided information which the Department
			 has reasonably requested during the four-month period. This general requirement
			 is subject to the following limited exemptions:
(1) In cases where the Department requests an
			 independent cost analysis pursuant to
			 105 CMR
			 100.405(D)  and M.G.L. c.
			 Ill, § 25C(h), the four-month period shall be stayed until a final
			 independent cost-analysis is deemed complete and accepted by the Commissioner;
			 or
(2) A request for postponement
			 pursuant to
			 105
			 CMR 100.555 shall stay the running of the
			 four-month period for Department action; or
(3) The Department takes preliminary action
			 pursuant to
			 105 CMR
			 100.620. Such action shall constitute a Final
			 Action taken by the Department.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 100.000 - Determination of Need › Section 100.620 - Preliminary Action by the Department

Current through Register 1525, July 5, 2024
In cases where the Department considers Final Action
				inappropriate, the Department may take preliminary action upon an Application.
				As preliminary action upon an Application, the Department may direct Department
				Staff to take one or more of the following actions:
(1) Notify the Applicant and all Parties of
			 Record of its intent to resume consideration of the Application at a subsequent
			 Department meeting;
(2) Conduct
			 further Department Staff review of the Application in the manner directed, and
			 to report in writing to the Department within a specified period of
			 time;
(3) Conduct a public hearing
			 consistent with
			 105 CMR 100.445
			 with respect to the Application on such subjects and within such period of time
			 as specified by the Department;
(4)
			  Request comments from Parties of Record with respect to such
			 issues, and within such period of time, as specified by the Department;
			 and/or
(5) Take other action(s)
			 necessary, in the opinion of the Department, to facilitate appropriate Final
			 Action on the Application by the Department.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 100.000 - Determination of Need › Section 100.625 - Notification of Final or Preliminary Action

Current through Register 1525, July 5, 2024
(A)
			 Upon the Department taking Final Action upon an Application for Determination
			 of Need or request to amend a previously issued Notice of Determination of Need
			 pursuant to
			 105 CMR
			 100.615, the Department shall provide
			 appropriate written notification to all Parties of Record within 14 days of
			 said Final Action. Such written notification shall disclose the Final Action,
			 the rationale for said action, the terms and Conditions of any Notice of
			 Determination of Need, and the rights and duties of parties and agencies
			 notified with respect to said action.
(B) Upon the Department taking preliminary
			 action upon an Application for Determination of Need pursuant to
			 105 CMR
			 100.620, the Department shall provide
			 appropriate written notification to all Parties of Record within 14 days of
			 said preliminary action. Such written notification shall disclose the
			 preliminary action, the rationale for said action, the terms and Conditions of
			 any such preliminary action, and the rights and duties of parties and agencies
			 notified with respect to said action.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 100.000 - Determination of Need › Section 100.630 - Delegated Review

Current through Register 1525, July 5, 2024
(A) The Department
			 may appoint or direct the Commissioner to act on its behalf to take Final
			 Action for certain project categories designated pursuant to
			 105 CMR 100.630.
			 At a minimum, the following shall be included for delegated review and Final
			 Action by the Commissioner:
(1) Conservation
			 Projects;
(2) Transfer of Site or
			 change of a designated Location;
(3) An Application for a Proposed Project on
			 behalf of a Long-term Care Facility with a maximum Capital Expenditure below
			 $3,000,000;
(4) An Application
			 deemed to be an emergency Application by the Commissioner pursuant to
			 105 CMR
			 100.740;
(5) An Application for a Proposed Project
			 where the Applicant is a Government Agency; and
(6) An Application submitted from an
			 applicant that has or is a participant in a Certified ACO for a Proposed
			 Project that is, in total, a DoN-required Service or DoN-required
			 Equipment.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 100.000 - Determination of Need › Section 100.635 - Amendments to a Notice of Determination of Need

Current through Register 1525, July 5, 2024
(A) Following issuance of a Notice of
			 Determination of Need by the Department, no changes may be made to the project
			 without the issuance of a new Notice of Determination of Need with the
			 exception of an Immaterial Change or approval of a request for a Significant
			 Change.
A Significant Change must be within the scope of the Notice of
				Determination of Need as previously approved and the proposed change must be
				reasonable. The Holder, prior to implementing any Significant Change, shall
				submit to the Department a request for approval of the Significant Change that
				contains a narrative description of the previously approved project and of the
				proposed Significant Change and associated costs both to the Holder, as well as
				to the Holder's Patient Panel. The request shall additionally contain the
				rationale for such change. Department Staff may request additional information
				from the Holder. The Holder shall ensure that copies of all submitted
				information are simultaneously provided to all Parties of Record to the
				previously approved Notice of Determination of Need. No action shall be taken
				until such amendment request has been published consistent with
				105 CMR
				100.405(A)  for at least 30
				days. A public hearing may be requested by the Department or Parties of Record
				within 14 days of said information being properly posted. Following such
				period:
(1) For an amendment to a
			 Notice of Determination of Need previously issued by the Commissioner pursuant
			 to
			 105 CMR 100.630,
			 the Commissioner shall make a determination, consistent with
			 105 CMR
			 100.615 or
			 105 CMR
			 100.620, within 60 days, or may refer said
			 proposed Significant Change to the Department for further consideration and
			 Final Action; or
(2) For an
			 amendment to a Notice of Determination of Need previously issued by the
			 Department, the Department shall make a determination, pursuant to
			 105 CMR
			 100.615,
			 100.620,
			 or
			 100.640,
			 within 60 days.
Final Action by the Department shall conform to the provisions
				of
				105 CMR
				100.625. Such Final Actions may include
				additional terms and Conditions to be attached to the Notice of Determination
				of Need. All information submitted in relation to the request for Significant
				Change shall be public, consistent with
				105 CMR
				100.405(A).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 100.000 - Determination of Need › Section 100.640 - Revocation of a Previously Approved Notice of Determination of Need

Current through Register 1525, July 5, 2024
(A) The Department may revoke a previously
			 issued Notice of Determination of Need for failure by the Holder to comply with
			 all terms and Conditions of the Notice of Determination of Need. Should the
			 Commissioner have reasonable cause to recommend revocation of a previously
			 issued Notice of Determination of Need by the Department, the Commissioner
			 shall comply with the following procedures:
(1) The Commissioner shall make a preliminary
			 inquiry of the Holder in order to clarify compliance with all Notice of
			 Determination of Need terms and Conditions.
(2) The Commissioner may, following
			 preliminary inquiry, place consideration of the proposed revocation on the
			 agenda of a Department meeting.
(3)
			 At least 21 days prior to consideration of a proposed revocation by the
			 Department, Department Staff shall provide written notification to the Holder
			 and all Parties of Record to the previously approved Notice of Determination of
			 Need. Such notification shall disclose the proposed revocation, the rationale
			 for said proposed revocation, and the rights and duties of parties and agencies
			 notified with respect to said proposed revocation.
(4) The Department shall afford an
			 opportunity to speak to the Holder and to all parties of Record to the
			 previously approved Notice of Determination of Need. The Department shall take
			 action as it deems fair and appropriate.
(5) Revocation by the Department pursuant to
			 105
			 CMR 100.640 shall conform to the provisions
			 of
			 105 CMR
			 100.625.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 100.000 - Determination of Need › Section 100.705 - Standing to File an Application for Determination of Need

Current through Register 1525, July 5, 2024
(A) No Person shall be permitted to make an
			 Application for Notice of Determination of Need pursuant to 105 CMR 100.000
			 unless such Person has Sufficient Interest in the Site or facility, and unless
			 such Site or facility may be used for the Proposed Project, meaning one of the
			 following:
(1) The Proposed Project is
			 authorized under applicable zoning bylaws or ordinances, whether or not a
			 special permit is required; or
(2)
			 If the Proposed Project is not authorized under applicable zoning bylaws or
			 ordinances, a variance has been received to permit such Proposed Project;
			 or
(3) The Proposed Project is
			 exempt from zoning bylaws or ordinances.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 100.000 - Determination of Need › Section 100.726 - Exemptions for Certain Substantial Capital Expenditures and Substantial Changes in Service

Current through Register 1525, July 5, 2024
(A) No Notice of
			 Determination of Need shall be required for any Substantial Capital Expenditure
			 or any Substantial Change in Service that is solely related to the conduct of
			 basic biomedical research or applied medical research. However, Entities making
			 a Substantial Capital Expenditure or Substantial Changes in Service pursuant to
			 105
			 CMR 100.715 shall notify the Department, in
			 the form and manner as specified by the Commissioner, at least 60 days prior to
			 undertaking such an expenditure or change in service. Such Provider
			 Organizations shall be required to report information concerning said research
			 project(s) to the Department, in the form, manner, and frequency as reasonably
			 requested by the Commissioner.
(B)
			 Notice of Determination of Need shall be required for any Substantial Capital
			 Expenditure or any Substantial Change in Service that is solely related to the
			 conduct of basic biomedical research or applied medical research if it results
			 in any of the following:
(1) Any increase in
			 the number of clinical beds or outpatient capacity of a Health Care
			 Facility;
(2) Any increase in the
			 gross patient service revenue of a Health Care Facility;
(3) Determination by the Commissioner that
			 the Health Care Facility notification pursuant to
			 105
			 CMR 100.715 does not constitute an
			 expenditure or change in service that is solely related to the conduct of basic
			 biomedical research or applied medical research; or,
(4) Failure by a Health Care Facility to
			 comply with the notification requirement outlined within 105 CMR
			 100.726(A).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 100.000 - Determination of Need › Section 100.730 - Determination of Need for Original Licensure

Current through Register 1525, July 5, 2024
(A)
Applicability
.
(1)
			 Pursuant to M.G.L. c. Ill, §§ 51 through 53, no Person shall be
			 issued an Original License to establish or maintain a Hospital, a Freestanding
			 Ambulatory Surgery Center, an inpatient unit of a Health Care Facility off the
			 Premises of the Health Care Facility, or the placement of inpatient services at
			 a previously-licensed outpatient satellite of a Health Care Facility, unless
			 the Department has first issued a Notice of Determination of Need for the
			 Proposed Project at the designated Location.
(2) No Person shall be issued an Original
			 License to establish or maintain a facility licensed by a Government Agency
			 which requires a Determination of Need as a condition of Original Licensure
			 unless the Department has first issued a Notice of Determination of Need for
			 the Proposed Project at the designated Location.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 100.000 - Determination of Need › Section 100.735 - Transfer of Ownership - Applicability

Current through Register 1525, July 5, 2024
(A)
			 Pursuant to M.G.L. c. 111, §§ 51 through 53, no Person shall be
			 issued an Original License for a Hospital, a Freestanding Ambulatory Surgery
			 Center, an inpatient unit of a Health Care Facility off the Premises of the
			 Health Care Facility, or the placement of inpatient services at a
			 previously-licensed outpatient satellite of a Health Care Facility, unless the
			 Department has first issued a Notice of Determination of Need for such Proposed
			 Project at the designated Location.
(B) No Person shall be issued an Original
			 License for any facility licensed by a Government Agency which requires a
			 Determination of Need as a condition of Original Licensure unless the
			 Department has issued a Notice of Determination of Need for such Proposed
			 Project at the designated Location.
(C) No Notice of Determination of Need for a
			 Transfer of Ownership shall be issued by the Department unless the Proposed
			 Project includes the transfer of the Health Care Facility's license in its
			 entirety to a single transferee.
(D) The transferee, by operation of the
			 Notice of Determination of Need issued pursuant to this section, becomes the
			 Holder of any Notice of Determination of Need then held by any entity being
			 acquired.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 100.000 - Determination of Need › Section 100.740 - Emergency Applications

Current through Register 1525, July 5, 2024
(A)
Applicability
. Any Person believing an Emergency
			 Situation exists may file an Application for a Determination of Need by filing
			 with the Department a written notification, signed under the pains and
			 penalties of perjury by both the Applicant's chief executive officer and board
			 chair, which sets forth the identity of the Applicant, the nature of the
			 Emergency Situation, as well as the nature, scope, Location, and projected
			 costs of the Proposed Project. An Application filed pursuant to
			 105 CMR
			 100.740 shall convincingly demonstrate that
			 the Proposed Project will address the Emergency Situation, and without issuance
			 of a Notice of Determination of Need, that the public health will be measurably
			 harmed.
(B)
Other
			 Application Processes
. Unless otherwise specified by the
			 Commissioner, an Applicant filing an Application for Determination of Need made
			 pursuant to
			 105 CMR
			 100.740 shall be subject to the following:
(1) Within 30 days of receipt of the written
			 notification required pursuant to
			 105 CMR
			 100.740, the Commissioner shall determine
			 whether there is, in fact, an Emergency Situation. If deemed an Emergency
			 Situation, the Commissioner may issue a Notice of Determination of Need,
			 notifying Parties of Record consistent with
			 105 CMR
			 100.625. The Commissioner may subsequently
			 require a full Application for Determination of Need consistent with
			 105 CMR
			 100.405.
(2) In the case of an Application for
			 Determination of Need made pursuant to
			 105 CMR
			 100.740, notice of intent of the Application
			 may be given after the Application has been filed with the Department.
			 Publication of notice of intent shall otherwise be as prescribed within
			 105 CMR
			 100.405(C).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 100.000 - Determination of Need › Section 100.745 - Transfer of Site or Change of Designated Location

Current through Register 1525, July 5, 2024
(A) No Person shall make a transfer of Site
			 of a Health Care Facility, DoN-required Service, or DoN-required Equipment nor
			 shall any Person change the designated Location of an Original License as
			 outlined within
			 105 CMR
			 100.730(A), unless the
			 Person first provides written notification to the Department, in the form and
			 manner as required by the Commissioner, and the Department determines whether
			 or not the proposed transfer of Site or Change of Designated Location will
			 result in a Substantial Capital Expenditure or Substantial Change in
			 Service.
(B) No Holder that has
			 received a previously issued Notice of Determination of Need for a project that
			 is not yet licensed, or not yet operational if there is no requirement for a
			 license, shall make a transfer of Site, unless the Holder first provides
			 written notification to the Department, in the form and manner as required by
			 the Commissioner, and the Department determines whether or not the proposed
			 transfer of Site will result in a Substantial Capital Expenditure or
			 Substantial Change in Service.
(C)
			 The Department shall determine based on the information supplied within the
			 written notification whether the proposed transfer of Site or change of
			 designated Location will either:
(1) result in
			 a Substantial Capital Expenditure or Substantial Change in Service, and
			 therefore will first require a Notice of Determination of Need issued pursuant
			 to
			 105
			 CMR 100.715; or
(2) shall first require a Notice of
			 Determination of Need issued pursuant to
			 105 CMR
			 100.730.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 100.000 - Determination of Need › Section 100.800 - Expected and Appropriate Conduct by Applicants

Current through Register 1525, July 5, 2024
(A) An Applicant shall fully cooperate with
			 the Department and all applicable Government Agencies.
(B) With respect to its own Application for
			 Determination of Need, an Applicant may only seek to convince the Department of
			 the appropriateness of taking favorable action on the Application by utilizing
			 one or more of the following methods:
(1) By
			 submitting material(s) supporting the Application;
(2) By requesting a public hearing(s)
			 pursuant to
			 105 CMR
			 100.445;
(3) By filing written reaction to the staff
			 report pursuant to
			 105 CMR
			 100.510; or
(4) By making an oral presentation to the
			 Department or Parties of Record.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 100.000 - Determination of Need › Section 100.805 - Advisory Rulings

Current through Register 1525, July 5, 2024
(A) Pursuant to
			 M.G.L. c. 30A, § 8, the Department may, upon the request of any Person,
			 make an advisory ruling with respect to the applicability to any Person,
			 property, or state of facts of any provision of 105 CMR 100.000.
(B) Any Person desiring an advisory ruling
			 shall direct its request, in writing, to the Department, "Attention: Office of
			 the General Counsel, Determination of Need Program".
(C) Each such request shall be titled
			 "Request for Advisory Ruling" and shall set forth, clearly and succinctly, the
			 following:
(1) Name;
(2) Organization, if applicable;
(3) Address of the Person making the
			 request;
(4) Interest in, or
			 relationship to, any regulated party;
(5) A statement of the facts with respect to
			 which the advisory ruling is requested; and
(6) The statutory provision or the section of
			 105 CMR 100.000 involved. The Person making such a request may also include
			 their views and opinions.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 100.000 - Determination of Need › Section 100.815 - Waivers

Current through Register 1525, July 5, 2024
(A) The Commissioner, within his or her
			 authority, may waive any requirement of 105 CMR 100.000. The Commissioner shall
			 notify the Public Health Council of any waiver issued within 60 days of
			 issuance.
(B) Any waiver granted
			 pursuant to
			 105 CMR 100.815(A)
			  shall describe the requirement that has been
			 waived, the rationale for the waiver, and any applicable terms and Conditions
			 attached thereto.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 100.000 - Determination of Need › Section 100.820 - Enforcement and Penalties

Current through Register 1525, July 5, 2024
Pursuant to M.G.L. c. Ill, § 25G, the superior and supreme
				judicial courts shall have jurisdiction, upon request of the Department, or of
				any Ten Taxpayer Group in Massachusetts to enforce any provision of 105 CMR
				100.000. A violation of any such provision shall subject the violator to
				liability for a civil penalty of not more than $500 for each day of such
				violation, assessable by the superior court. A violation of any such provision
				shall constitute grounds for refusing to grant, renew, modify, or revoking the
				license of a Health Care Facility or of any part thereof.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 100.000 - Determination of Need › Section 100.825 - Severability

Current through Register 1525, July 5, 2024
The provisions of 105 CMR 100.000 are severable. If a court of
				competent jurisdiction declares any section, subsection, paragraph, or
				provision unconstitutional or invalid, the validity of the remaining provisions
				shall not be affected.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › Section 120.002 - Purpose and Scope

Current through Register 1525, July 5, 2024
Except as otherwise specifically provided, 105 CMR 120.000
				apply to all persons who receive, possess, use, transfer, own, or acquire any
				source of radiation; provided, however, that nothing in 105 CMR 120.000 shall
				apply to any person to the extent such person is subject to regulation by the
				U.S. Nuclear Regulatory Commission (NRC). Regulation by the Commonwealth of
				source material, byproduct material, and special nuclear material in quantities
				not sufficient to form a critical mass is subject to the provisions of the
				agreement between the State and the NRC and to 10 CFR Part 150 of the NRC's
				regulations.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › Section 120.003 - Regulatory Authority

Current through Register 1525, July 5, 2024
The authority for the Department of Public Health to promulgate
				105 CMR 120.000 is found in: M.G.L. c. 111, §§ 3, 5M, 5N, 5O, and
				5P.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › Section 120.006 - Exemptions

Current through Register 1525, July 5, 2024
(A)
General
			 Provision
. The Agency may, upon application therefore or upon its
			 own initiative, grant such exemptions or exceptions from the requirements of
			 105 CMR 120.000 as it determines are authorized by law and will not result in
			 undue hazard to public health and safety or property.
(B)
U.S. Department of Energy
			 Contractors and U.S. Nuclear Regulatory Commission Contractors
.
			 Any U.S. Department of Energy contractor or subcontractor and any U.S. Nuclear
			 Regulatory Commission contractor or subcontractor of the following categories
			 operating within this Commonwealth is exempt from 105 CMR 120.000 to the extent
			 that such contractor or subcontractor under his contract receives, possesses,
			 uses, transfers or acquires sources of radiation:
(1) Prime contractors performing work for the
			 U.S. Department of Energy at U.S. Government-owned or Government-controlled
			 sites, including the transportation of sources of radiation to or from such
			 sites and the performance of contract services during temporary interruptions
			 of such transportation;
(2) Prime
			 contractors of the U.S. Department of Energy performing research in, or
			 development, manufacture, storage, testing, or transportation of, atomic
			 weapons or components thereof;
(3)
			 Prime contractors of the U.S. Department of Energy using or operating nuclear
			 reactors or other nuclear devices in a United States Government-owned vehicle
			 or vessel; and,
(4) Any other prime
			 contractor or subcontractor of the U.S. Department of Energy or of the U.S.
			 Nuclear Regulatory Commission when the State and the U.S. Nuclear Regulatory
			 Commission jointly determine:
(a) That the
			 exemption of the prime contractor or subcontractor is authorized by law;
			 and
(b) That under the terms of the
			 contract or subcontract, there is adequate assurance that the work thereunder
			 can be accomplished without undue risk to the public health and
			 safety.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › Section 120.007 - Prohibited Uses

Current through Register 1525, July 5, 2024
(A) A hand-held
			 fluoroscopic screen shall not be used with x-ray equipment unless it has been
			 listed in the Registry of Sealed Source and Devices or accepted for
			 certification by the U.S. Food and Drug Administration, Center for Devices and
			 Radiological Health.
(B) A
			 Shoe-fitting fluoroscopic device shall not be used.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › Section 120.009 - Records

Current through Register 1525, July 5, 2024
(A) Each licensee and registrant shall
			 maintain records showing the receipt, transfer, and disposal of all sources of
			 radiation. Additional record requirements are specified elsewhere in
			 105
			 CMR 120.000.
(B) Prior to license termination, each
			 licensee authorized to possess radioactive material with a half-life greater
			 than 120 days, in an unsealed form, shall forward the following records to the
			 Agency:
(1) Records of disposal of licensed
			 material made under
			 105
			 CMR 120.252 (including burials authorized
			 before January 28, 1981),
			 105 CMR
			 120.253,
			 120.254,
			 120.255;
			 and,
(2) Records required by
			 105 CMR
			 120.263(B)(4).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › Section 120.010 - Inspections

Current through Register 1525, July 5, 2024
(A) Each licensee and registrant shall afford
			 the Agency at all reasonable times opportunity to inspect sources of radiation
			 and the premises and facilities wherein such sources of radiation are used or
			 stored.
(B) Each licensee and
			 registrant shall make available to the Agency for inspection, upon reasonable
			 notice, records maintained pursuant to
			 105
			 CMR 120.000.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › Section 120.011 - Tests

Current through Register 1525, July 5, 2024
Each licensee and registrant shall perform upon instructions
				from the Agency, or shall permit the Agency to perform, such reasonable tests
				as the Agency deems appropriate or necessary including, but not limited to,
				tests of:
(A) Sources of
			 radiation;
(B) Facilities wherein
			 sources of radiation are used or stored;
(C) Radiation detection and monitoring
			 instruments; and,
(D) Other
			 equipment and devices used in connection with utilization or storage of
			 licensed or registered sources of radiation.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › Section 120.012 - Additional Requirements

Current through Register 1525, July 5, 2024
(A) The Agency may,
			 by rule, regulation, or order, impose upon any licensee or registrant such
			 requirements in addition to those established in
			 105
			 CMR 120.000 as it deems appropriate or necessary to
			 minimize danger to public health and safety or property.
(B) Any person who finds or detects any
			 source of radiation that is not under the physical or administrative control of
			 a licensee or registrant, and that is not excluded, exempted or otherwise
			 authorized under the provisions of
			 105
			 CMR 120.000, shall immediately report such source to
			 the Radiation Control Program.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › Section 120.013 - Communications

Current through Register 1525, July 5, 2024
All correspondence in compliance with
				105
				CMR 120.000 shall be sent to the Department of Public
				Health, Radiation Control Program, at the programs's current mailing address,
				as stated in the website
https://www.mass.gov/orgs/radiation-control-program
.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › Section 120.014 - Units of Exposure and Dose

Current through Register 1525, July 5, 2024
(A) As used in
			 105
			 CMR 120.000, the unit of
Exposure
is the coulomb per kilogram (C/kg) of air.
			 One roentgen is equal to 2.58 x 10-4 coulomb per
			 kilogram of air.
(B) As used in
			 105
			 CMR 120.000, the units of dose are:
Rad is the special unit of absorbed dose. One rad is equal to
				an absorbed dose of 100 ergs per gram or 0.01 joule per kilogram (0.01
				gray).
Gray (Gy) is the SI unit of absorbed dose. One gray is equal to
				an absorbed dose of 1 joule per kilogram (100 rads).
Rem is the special unit of any of the quantities expressed as
				dose equivalent. The dose equivalent in rem is equal to the absorbed dose in
				rad multiplied by the quality factor (1 rem = 0.01 sievert).
Sievert is the SI unit of any of the quantities expressed as
				dose equivalent. The dose equivalent in sievert is equal to the absorbed dose
				in gray multiplied by the quality factor (1 sievert = 100
				rems).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › Section 120.015 - Units of Activity

Current through Register 1525, July 5, 2024
For purposes of 105 CMR 120.000, activity is expressed in the
				SI unit of becquerel (Bq) or in the special unit of curie (Ci), or their
				multiples, or disintegrations or transformations per unit of time.
(A) One becquerel (Bq) = 1 disintegration or
			 transformation per second (dps or tps).
(B) One curie (Ci) = 3.7 x
			 1010 disintegrations or transformations per second
			 (dps or tps) = 3.7 x 1010 becquerel (Bq) = 2.22 x
			 1012 disintegrations or transformations per minute
			 (dpm or tpm).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › ENFORCEMENT › Section 120.016 - Enforcement Policy and Procedures

Current through Register 1525, July 5, 2024
(A)
Purpose
. The purpose of the enforcement program of the
				Agency is to promote and protect the radiological health and safety of the
				public, including employees' health and safety, and the environment by:
* Value of quality factor (Q) at
				  the point where the dose equivalent is maximum in a 30-centimeter diameter
				  cylinder tissue-equivalent phantom.
** Monoenergetic neutrons incident
				  normally on a 30-centimeter diameter cylinder tissue-equivalent phantom.
(1) Ensuring compliance with regulations and
				conditions of license;
(2)
				Obtaining prompt correction of violations that may affect safety;
(3) Deterring future violations;
				and
(4) Encouraging improvement of
				licensee, registrant and vendor performance, and by example, that of industry,
				including the prompt identification and reporting of potential safety problems.
Consistent with the purpose of this program, prompt and
				  vigorous enforcement action will be taken when dealing with all persons who do
				  not comply with regulations. In no case will licensees who do not achieve and
				  maintain adequate levels of protection be permitted to conduct licensed
				  activities.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › ENFORCEMENT › Section 120.017 - Severability

Current through Register 1525, July 5, 2024
The provisions of 105 CMR 120.000 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 120.000 - The Control of Radiation › ENFORCEMENT › Section 120.018 - Public Disclosure of Enforcement Actions

Current through Register 1525, July 5, 2024
In accordance with M.G.L. c. 30A, the Administrative
				  Procedures Act, all enforcement actions and licensees' responses are publicly
				  available for inspection. In addition, press releases may be issued for civil
				  penalties related to violations at Severity Level I, II, or
				  III.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › ENFORCEMENT › Section 120.019 - Appendix A - Severity Categories

Current through Register 1525, July 5, 2024
The following examples of severity levels are neither
				  exhaustive nor controlling. They reflect only the seriousness of the violation
				  and not the intent of the violator, the history of the violator, the amount
				  necessary to deter future violations, or efforts to correct the
				  violation.
(A)
Severity
				Level 1 - Most Significant Violations
.
(1)
Health Physics
.
(a) Single exposure of a worker in excess of
				25 rems of radiation to the whole body, 150 rems to the skin of the whole body,
				or 375 rems to the feet, ankles, hands or forearms;
(b) Annual whole body exposure of a member of
				the public in excess of 2.5 rems of radiation;
(c) Release of radioactive material to an
				unrestricted area in excess of ten times the limits of
				105 CMR
				120.253;
(d) Disposal of licensed material in
				quantities or concentrations in excess of ten times the limits of
				105 CMR
				120.253;
(e) Exposure of a worker in restricted areas
				of ten times the limits of
				105
				CMR 120.212.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › ENFORCEMENT › Section 120.021 - Purpose and Scope

Current through Register 1525, July 5, 2024
(A)105 CMR 120.020
				through
				120.040
				provides for the registration of radiation machine facilities and for the
				registration of persons providing radiation machine installation, servicing,
				and/or services to Department registrants or registrable facilities. For the
				purposes of 105 CMR 120.020, particle accelerators, whether used primarily for
				x-ray production or other purposes, shall be considered a radiation machine
				facility.
(B) In addition to the
				requirements of 105 CMR 120.020 through
				120.040,
				all registrants are subject to the applicable provisions of other parts of 105
				CMR 120.000.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › ENFORCEMENT › Section 120.022 - Definitions

Current through Register 1525, July 5, 2024
As used in 105 CMR 120.020 through
				  120.040,
				  "facility" means the location at which one or more devices or sources are
				  installed and/or located within one building, vehicle, or under one roof and
				  are under the same administrative control.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › ENFORCEMENT › Section 120.023 - Exemptions

Current through Register 1525, July 5, 2024
(A) Electronic equipment that produces
				radiation incidental to its operation for other purposes is exempt from the
				registration and notification requirements of 105 CMR 120.020 through
				120.040,
				providing dose equivalent rate averaged over an area of ten square centimeters
				does not exceed 0.5 millirem (5 j Sv) per hour at five centimeters from any
				accessible surface of such equipment. The production, testing, or factory
				servicing of such equipment shall not be exempt.
(B) Radiation machines while in transit or
				storage incident thereto are exempt from the requirements of 105 CMR 120.020
				through
				120.040.
(C) Domestic television receivers are exempt
				from the requirements of 105 CMR 120.020 through
				120.040.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › ENFORCEMENT › Section 120.024 - Plan Review

Current through Register 1525, July 5, 2024
(A) Prior to
				construction, the floor plans and equipment arrangements of all new
				installations, or modifications of existing installations, utilizing ionizing
				radiation for diagnostics or therapeutic purposes shall be submitted to the
				Agency for review and approval. The installation shall meet the requirements of
				105 CMR
				120.420:
Appendix A
and
				105 CMR
				120.422:
Appendix C
unless
				specifically exempted. Additional shielding and design requirements are
				specified elsewhere in 105 CMR 120.000.
(B) The Agency may require the applicant to
				utilize the services of a qualified expert to determine the shielding
				requirements prior to the plan review and approval.
(C) The approval of such plans shall not
				preclude the requirement of additional modifications should a subsequent
				analysis of operating conditions indicate the possibility of an individual
				receiving a dose in excess of the limits prescribed in
				105 CMR
				120.211,
				120.217,
				120.218
				and
				120.221.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › ENFORCEMENT › Section 120.025 - Application for Registration

Current through Register 1525, July 5, 2024
Each person who owns or possess and administratively controls
				  a facility, unless specifically exempted in
				  105 CMR 120.023
				  shall:
(A) Apply for registration of
				such facility with the Agency prior to the operation of a radiation machine
				facility. Application for registration shall be completed on forms furnished by
				the Agency and shall contain all the information required by the form and
				accompanying instructions.
(B)
				Designate on the application form an individual to be responsible for radiation
				protection.
(C) Each registrant
				shall prohibit any person from furnishing radiation machine servicing or
				services as described in
				105 CMR
				120.026(D)  to his radiation
				machine facility until such person provides evidence that he has been
				registered with the Agency as a provider of services in accordance with
				105 CMR
				120.026.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › ENFORCEMENT › Section 120.026 - Application for Registration Services

Current through Register 1525, July 5, 2024
(A) Each
				person, prior to engaging in the business of installing or offering to install
				radiation machines or engaging in the business of furnishing or offering to
				furnish radiation machine servicing or services in this Commonwealth shall
				apply for and receive registration for such services with the Agency.
(B) Application for registration shall be
				completed on forms furnished by the Agency and shall contain all information
				required by the Agency as indicated on the forms and accompanying
				instructions.
(C) Each person
				applying for registration under 105 CMR 120.020 through 120.040 shall specify:
(1) That he has read and understands the
				requirements of 105 CMR 120.020 through 120.040;
(2) The services for which he is applying for
				registration; and,
(3) The training
				and experience that qualify him to discharge the services for which he is
				applying for registration;
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › ENFORCEMENT › Section 120.027 - Certificate of Registration

Current through Register 1525, July 5, 2024
(A) No person shall
				maintain a facility that is required by 105 CMR 120.000 to be registered unless
				such a person has obtained a valid certificate of registration for such
				facility.
(B) A person who applies
				for registration and whose application meets the requirements of 105 CMR
				120.000, shall, upon payment of the required fee, be issued a certificate of
				registration effective on the date stated on such certificate.
(C) A current certificate of registration or
				a legible copy thereof shall be posted conspicuously at each registered
				facility.
(D) The Director of the
				Radiation Control Program may incorporate in the certificate of registration,
				at the time of issuance or thereafter, any such additional requirements and
				conditions with respect to the registrant's receipt, possession, use, and
				transfer of radiation machines as said Director finds appropriate and necessary
				for the protection of the general public or individuals against radiation
				hazards.