reglab/statecodes huggingface dataset:
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 135.000 - Use Of Blood, Blood Components, And Derivatives For The Purpose Of Transfusion › Enforcement › Section 135.130 - Proficiency Testing Requirements

Current through Register 1525, July 5, 2024
(A) Every
				blood bank subject to
				105 CMR 135.000 shall
				participate successfully in the Comprehensive Blood Bank Series J of the
				College of American Pathologists (CAP) or an equivalent program approved by the
				Department. The extent to which a blood bank participates will be determined by
				the procedures performed by that blood bank. A blood bank must be enrolled in
				such a program to the extent necessary to cover all testing which it uses for
				diagnosis or treatment. Every blood bank that performs infectious disease
				testing on donorblood for the purpose of approving blood for transfusion
				purposes shall successfully participate in the AABB-CAP Viral Markers Series W
				or an equivalent program approved by the Department.
(B) The Department shall set standards for
				successful participation that all blood banks and transfusion services shall
				meet.
(C) Any blood bank or
				transfusion service subject to
				105 CMR 135.000 which fails
				to meet any standard for successful participation specified by the Department
				will be required to submit such information as required by the
				Department.
(D)
(1) The Department may provide additional
				proficiency testing samples to a blood bank or transfusion service.
(2) Any proficiency testing samples provided
				by the Department shall meet the same criteria as samples used by the
				proficiency testing programs approved by the Department.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 135.000 - Use Of Blood, Blood Components, And Derivatives For The Purpose Of Transfusion › Enforcement › Section 135.140 - Denial or Revocation of License or Approval

Current through Register 1525, July 5, 2024
(A) Non-compliance with any of
				105 CMR 135.000 may result
				in denial, suspension or revocation of the license of the hospital of which the
				blood bank or transfusion service is a part or in the imposition of any other
				sanction which may be imposed on such a hospital under
				105 CMR
				130.000.
(B) Non-compliance with any applicable
				provisions of
				105 CMR 135.000 by a blood
				bank or transfusion service subject to M.G.L. c. 111, § 184B which is not
				part of a hospital subject to Department licensure may result in denial,
				suspension or revocation of any approval.
(C) Non-compliance with any applicable
				provisions of
				105 CMR 135.000 by a
				transfusion service which is a part of an out-of-hospital service subject to
				Department licensure under M.G.L. c.111, § 51A may result in denial or
				revocation of the license of the out-of-hospital service or temporary or
				permanent withdrawal of the right of the out-of-hospital service to operate a
				transfusion service.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 135.000 - Use Of Blood, Blood Components, And Derivatives For The Purpose Of Transfusion › General Requirements › Section 135.200 - Requirements

Current through Register 1525, July 5, 2024
All blood banks and transfusion services shall comply with
				  the most recent AABB edition of "Standards for Blood Banks and Transfusion
				  Services". In addition, for the purpose of applying
				  105 CMR 135.000, all AABB
				  Standards which incorporate the word "should" will be taken to mean "shall"
				  except upon written authorization by the blood bank director for good cause.
				  The blood bank or transfusion service shall document the rationale for all such
				  authorizations. The blood bank's or tranfusion service's procedure manual may
				  serve as an acceptable form of authorization.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 135.000 - Use Of Blood, Blood Components, And Derivatives For The Purpose Of Transfusion › General Requirements › Section 135.210 - Personnel, Qualifications, and Training

Current through Register 1525, July 5, 2024
(A)
				Any change in the position of blood bank director shall be reported to the
				Department within 30 days.
(B)
				Blood donor screening and venipuncture procedures shall be performed only by
				suitably qualified individuals who have received appropriate training. The
				blood bank shall maintain records documenting the training of such qualified
				individuals. On going continuing education and retraining shall be provided if
				applicable or as needed. Training must be provided by experienced health
				professionals with experience in clinical detection, measurement and analysis
				appropriate to the donor screener's responsibilities. The training programs
				must include at a minimum:
(1) a thorough
				training on content and application of pertinent screening protocols;
(2) a thorough training on venipuncture blood
				collection and processing procedures;
(3) a thorough training on worker and patient
				safety including emergency procedures required to aid a distressed
				donor;
(4) a means for testing
				employee technique and proficiency in performing assigned duties and
				responsibilities. Such assessments shall be made by the blood bank director (or
				his/her designee) on an annual basis and shall make personal inspections of the
				donor centers to insure suitable handling of donors and to instruct
				employees.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 135.000 - Use Of Blood, Blood Components, And Derivatives For The Purpose Of Transfusion › General Requirements › Section 135.220 - Special Donor Screening Protection Requirements

Current through Register 1525, July 5, 2024
The blood bank, in addition to using established donor
				  screening criteria to protect donors from ill effects of blood donation,
				  shall:
(A) define pertinent screening
				parameters and/or test levels which may indicate or contribute to a disease
				state;
(B) inform the donor of all
				significant findings including disease risk(s) and, as necessary, provide
				medical counselling and/or referral.
The blood bank may establish a tier system in responding to
				  degrees of disease risk(s). It is not necessary for the defined action
				  parameters/levels to correspond to the ranges resulting in donor
				  deferral.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 135.000 - Use Of Blood, Blood Components, And Derivatives For The Purpose Of Transfusion › General Requirements › Section 135.230 - Contaminated Materials

Current through Register 1525, July 5, 2024
All infectious or physically dangerous medical waste,
				  including blood saturated materials and sharps, must be stored and disposed of
				  in accordance with the requirements set forth in
				  105 CMR 480.000 of the
				  State Sanitary Code, Chapter VIII.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 135.000 - Use Of Blood, Blood Components, And Derivatives For The Purpose Of Transfusion › General Requirements › Section 135.240 - Significant Reactions

Current through Register 1525, July 5, 2024
(A) All fatal
				transfusion reactions shall be reported to the Bureau of Biologics of the FDA
				and to the Department.
(B) All
				fatal donor reactions shall be reported to the Department.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 135.000 - Use Of Blood, Blood Components, And Derivatives For The Purpose Of Transfusion › General Requirements › Section 135.250 - Donor Immunization and Hyperimmunization

Current through Register 1525, July 5, 2024
(A) Every immunization or hyperimmunization
				program undertaken to enhance the usefulness of the recipient's plasma for
				subsequent donation as whole blood or plasma shall be supervised and approved
				by an institutional review board established and conducted in the manner
				specified in 21 C.F.R. Part 312 concerning supervision of new drugs for
				investigational use.
(B) The
				selection and scheduling of the injection of the antigen, and the evaluation of
				each donor's clinical response, shall be by a qualified physician.
(C) Antigens used in such programs shall be
				either a product licensed under Section 351 of the Public Health Service Act,
				42 U.S.C. § 262, for such purpose or one specifically approved by the
				Director, Bureau of Biologics, FDA.
(D) If there is no suitable licensed antigen,
				a full description of the antigen to be used should be provided to the
				institutional review board established pursuant to 105 CMR 135.250(A), which
				should be convinced of the safety of the antigen preparation and be assured
				that the donor will not be harmed as a result of the procedure. All antigens
				should be sterile, or when viable antigens are used should be free of all other
				infectious agents, as determined by appropriate test before use.
(E) Schedules for administration of antigen,
				criteria for acceptability of plasma, and anticipated results with suitable
				standards by the assay to be used shall be made available to the institutional
				review board established pursuant to 105 CMR 135.250(A) before the procedure is
				begun.
(F) All records concerning
				the antigen, the laboratory characteristics of the plasma donor, and the
				immunization schedule shall be retained by the blood bank for a least five
				years after the donor retires from the program.
(G) The selection and administration of human
				erythrocytes as antigens should be subject to the following additional
				safeguards:
(1) The erythrocyte donor must
				meet all the requirements intended for the safety of the recipient that apply
				to whole blood donors for transfusion.
(2) Aliquots of large quantities of
				freeze-preserved erythrocytes from donors whose blood is considered to carry a
				minimal risk of transfusion-transmitted diseases should be used when
				possible.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 135.000 - Use Of Blood, Blood Components, And Derivatives For The Purpose Of Transfusion › General Requirements › Section 135.260 - Waiver of Requirements Imposed on Blood Banks and Transfusion Services

Current through Register 1525, July 5, 2024
(A) The Commissioner may waive the
				applicability to a particular blood bank or transfusion service of one or more
				of the requirements imposed on that blood bank or transfusion service by
				105 CMR 135.000 if the
				Commissioner finds that:
(1) compliance would
				cause undue hardship; and
(2) the
				blood bank or transfusion service is in substantial compliance with the spirit
				o f the requirement; and
(3) the
				blood bank's or transfusion service's non-compliance does not adversely affect
				the quality of the blood bank.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 135.000 - Use Of Blood, Blood Components, And Derivatives For The Purpose Of Transfusion › Transfusion Practices › Section 135.400 - Personnel, Qualifications, and Training

Current through Register 1525, July 5, 2024
A transfusion shall be performed only by:
(A) A physician; or
(B) A registered nurse, registered by the
				Board of Registration in Nursing under M.G.L. c. 112, § 74, who is
				specially trained for this duty, provided that a physician shall be available
				within 15 minutes to respond to any adverse reaction to the transfusion by the
				recipient.
(C) Other personnel,
				approved by the health care facility, who are specially trained for this duty,
				provided that a physician shall be available within 15 minutes to respond to
				any adverse reaction to the transfusion by the recipient.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 135.000 - Use Of Blood, Blood Components, And Derivatives For The Purpose Of Transfusion › Transfusion Practices › Section 135.410 - Transfusion Outside of a Licensed Hospital

Current through Register 1525, July 5, 2024
(A) No transfusion shall be performed outside
				of a transfusion service within a licensed hospital unless the blood products
				are obtained through an agreement with a blood bank governed by
				105 CMR 135.000 and are
				administered in one of the following circumstances:
(1) In an out-patient kidney dialysis
				facility licensed under
				105 CMR 145.000 for
				dialysis-related purposes.
(2) In
				dialysis-related treatment of a home dialysis patient, providing there is
				documentation that the dialysis helper has been adequately trained in
				transfusion practices and precautions.
(3) In the home treatment of
				hemophilia.
(4) In other unusual
				circumstances, to protect patient health or safety, as deemed necessary by a
				blood bank director, providing that:
(a) the
				blood bank director reviews and approves the procedures being used to
				accomplish the transfusion; and
(b)
				the physician ordering the transfusion is responsible for the administration of
				the blood or blood product to the patient.
(5) In a health care facility or service
				setting (other than a hospital) licensed by the Department, under agreement
				with a blood bank and if authorized by the relevant health care facility or
				service setting licensure regulations.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Section 140.010 - Scope

Current through Register 1525, July 5, 2024
105 CMR 140.000 applies to
				every clinic subject to licensure under M.G.L. c. 111, §§ 51 through
				56, including any satellites of a licensed clinic that are not independently
				licensed.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Section 140.025 - Special Projects

Current through Register 1525, July 5, 2024
The Department will consider proposals for special projects for
				the innovative delivery of clinic 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 140.000 - Licensure Of Clinics › Section 140.099 - Waiver of Requirements Imposed on Clinics

Current through Register 1525, July 5, 2024
The Department may waive the applicability to a particular
				clinic of one or more of the requirements imposed on clinics by
				105 CMR
				140.000 if:
(A) the Department finds:
(1) compliance would cause undue hardship to
			 the clinic;
(2) the clinic is in
			 substantial compliance with the spirit of the requirement; and
(3) the clinic's noncompliance does not
			 jeopardize the health or safety of its patients and does not limit the clinic's
			 capacity to give adequate care.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Application for License › Section 140.101 - Requirement of License

Current through Register 1525, July 5, 2024
Every entity within the definition of "clinic" in M.G.L. c.
					 111, § 52 is required by M.G.L. c. 111, §§ 51 and 56 to obtain a
					 clinic license from the Department covering all locations at which the clinic
					 provides services.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Application for License › Section 140.102 - Application for a License

Current through Register 1525, July 5, 2024
(A) Applications for
				  licensure shall be made on forms prescribed by the Department. The term
				  "application" as used in 105 CMR 140.102 shall include initial and renewal
				  applications.
(B) In support of an
				  application for an original or renewal license, each applicant shall submit the
				  following information, updated as required by
				  105 CMR
				  140.107:
(1) Information concerning ownership or
				  control that identifies:
(a) If owned by an
				  individual, partnership or trust, the names and ownership percentages of such
				  individual, partners or trustees, except, in the case of a limited partnership,
				  such information shall be provided only for those limited partners owning 5% or
				  more of the partnership interest and the general partner.
(b) If owned by a privately held for-profit
				  corporation, the names of all stockholders who hold 5% or more of any class of
				  the outstanding stock, specifying the percentage owned.
(c) If owned by a not-for-profit corporation,
				  the names of the members and directors of the corporation.
(d) The name and ownership percentage of each
				  individual who directly or indirectly has any ownership interest of 5% or more,
				  unless otherwise provided pursuant to 105 CMR 104.102(B)(1)(a), (b) or
				  (c).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Application for License › Section 140.103 - Other Licensing Requirements

Current through Register 1525, July 5, 2024
(A)
Ownership Interest
. An applicant or licensee must be
				  the owner of the premises on which the facility is operated or lessee of the
				  premises for at least one year.
(B)
Name
. Each clinic applying for a license shall be
				  designated by a permanent and distinctive name, which shall appear on the
				  application for a license. The Department may disapprove any name that
				  misrepresents or may otherwise mislead the public regarding the ownership of
				  the clinic or the services provided. A clinic may not change its name without
				  prior approval by the Department.
(C)
Prior Approvals
.
				  As a prerequisite for a license, all applicants must obtain and submit the
				  following documents in support of the application for licensure:
(1) a copy of the certificate of inspection
				  issued by a building inspector of the Department of Public Safety or
				  appropriate local jurisdiction stating the clinic and any satellite clinic
				  premises comply with the Department's requirements governing egresses, fire
				  prevention, and fire extinguishing apparatus; and
(2) a copy of the certificate of inspection
				  issued by the head of the local fire department stating the clinic and any
				  satellite clinic premises comply with local ordinances.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Application for License › Section 140.104 - Timing of Application

Current through Register 1525, July 5, 2024
(A) In the case of a
				  transfer of ownership, the application shall be submitted no later than two
				  business days following the transfer; provided, however, the Department will
				  not accept an application from any owner who was not found suitable pursuant to
				  105 CMR
				  140.109.
(B) Clinics shall submit applications for
				  renewals at least 60 days prior to expiration of the license.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Application for License › Section 140.105 - Transfer of Ownership and Change in Location

Current through Register 1525, July 5, 2024
(A) A licensed clinic must notify the
				  Department in writing of any proposed change in name or location of a facility
				  at least 30 days prior to the change. A license shall not be transferred from
				  one person or entity to another or from one location to another.
(B) The proposed licensee shall submit a
				  Notice of Intent form to acquire a clinic to the Department at least 30
				  calendar days in advance of any transfer of ownership.
(C) Any person applying for a license as a
				  result of any transfer of ownership shall file an application for licensure
				  within two business days of the transfer. If the Notice of Intent form was not
				  timely filed, at the discretion of the Commissioner, an application received as
				  a result of a transfer of ownership will not be considered as filed for 30
				  calendar days, or such longer period as the Commissioner shall designate in
				  order to conduct a suitability review, after such application is
				  received.
(D) An application filed
				  as a result of a transfer of ownership, if timely filed, shall have the effect
				  of a license for a period of three months from the date of filing or until such
				  time as the Department takes action on the application. If not timely filed,
				  such an application shall not have such effect.
(E) Any notice of hearing, order or decision
				  the Department or the Commissioner issues for a clinic 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.
(F) A transfer of
				  ownership shall not be recognized and the new owner shall not be considered
				  suitable for licensure when the transfer is proposed or made to circumvent the
				  effect and purposes of
				  105 CMR
				  140.000. The Department shall consider the following
				  factors in determining whether a transfer has been proposed or made to
				  circumvent
				  105 CMR
				  140.000:
(1) the
				  transferor's record of compliance with Department licensure laws and
				  105 CMR
				  140.000;
(2) the transferor's current licensure
				  status;
(3) the transferor's
				  familial, business and/or financial relation to the transferee;
(4) the terms of the transfer; and
(5) the consequences of the
				  transfer.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Application for License › Section 140.106 - Acceptance of Application

Current through Register 1525, July 5, 2024
(A) The Department
				  shall not accept an application for an original or renewal license unless:
(1) the application includes all information
				  required by the Department;
(2) the
				  application and all required attachments and statements submitted by the
				  applicant meet the requirements of
				  105 CMR
				  140.000; and
(3) the applicant has paid all required
				  fees.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Application for License › Section 140.107 - Updating of Information

Current through Register 1525, July 5, 2024
Each licensee shall keep current all ownership or control
					 information submitted under the requirements of
					 105 CMR
					 140.000 or otherwise required by the Commissioner.
					 Each licensee shall file any document that amends, supplements, updates or
					 otherwise alters any ownership or control document with the Department within
					 30 calendar days of the execution thereof. Each licensee shall file any changes
					 in, or additions to, the content of the information contained in any ownership
					 or control document required to be filed to the Department within 30 calendar
					 days of such change or addition.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Application for License › Section 140.108 - Evaluation of Application

Current through Register 1525, July 5, 2024
The Department shall not approve an application for
					 original or renewal license, unless:
(A) the Department has conducted an
				  inspection or other investigation of the facility and has determined the
				  applicant complies with all applicable provisions in
				  105 CMR
				  140.000;
(B) the Commissioner has conducted an
				  investigation of the proposed licensee(s) and determined each proposed licensee
				  is suitable and responsible to establish or maintain a clinic; and
(C) in the case of original licensure or
				  addition of a satellite unit, the Department has determined there is need for
				  the facility at the designated location if the facility is subject to
				  determination of need pursuant to M.G.L. c. 111, § 51.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Application for License › Section 140.109 - Evidence of Responsibility and Suitability

Current through Register 1525, July 5, 2024
(A) In determining whether an applicant is
				  responsible and suitable to be granted a clinic license, the Department shall
				  consider all relevant information including, but not limited to, the following:
(1) the proposed licensee's history of prior
				  compliance with Massachusetts state laws and regulations governing health
				  facility operation. Assessment of this factor shall include the ability and
				  willingness of the proposed licensee to take corrective action when notified by
				  the Department of any regulatory violations;
(2) the proposed licensee's financial
				  capacity to provide services in compliance with state law and
				  105 CMR
				  140.000 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
				  proposed licensee and clinic administrator, officers and directors as evidenced
				  by criminal proceedings against those individuals resulting in convictions, or
				  guilty pleas, or pleas of
nolo contendere
, or admission of
				  sufficient facts; and (4) the proposed licensee's history of suspension,
				  revocation, or refusal to grant or renew a health care facility license in
				  other jurisdictions, or suspension, revocation or refusal of certification for
				  Medicaid or Medicare to the proposed licensee.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Inspection › Section 140.110 - Right to Visit and Inspect

Current through Register 1525, July 5, 2024
The Department or its agents may visit and inspect a
					 clinic, satellite, or mobile or portable unit subject to licensure under M.G.L.
					 c. 111, § 51 at any time without prior notice in order to determine the
					 clinic's compliance with state law and
					 105 CMR
					 140.000. All parts of the clinic, satellite, or mobile
					 or portable unit (including the site of any mental health outreach program),
					 all staff and activities, and all records are subject to such visit and
					 inspection.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Inspection › Section 140.111 - Frequency of Inspection

Current through Register 1525, July 5, 2024
The Department shall make an inspection or other
					 investigation prior to the issuance of every license. Additional inspections
					 may be made, consistent with the availability of staff, whenever the
					 Commissioner deems it necessary for the enforcement of
					 105 CMR
					 140.000.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Inspection › Section 140.112 - Deficiency Statements

Current through Register 1525, July 5, 2024
After every inspection in which any violation of
					 105 CMR
					 140.000 is observed, the Commissioner shall prepare a
					 deficiency statement citing every violation observed, a copy of which shall be
					 sent to the clinic.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Inspection › Section 140.113 - Plan of Correction

Current through Register 1525, July 5, 2024
(A) A clinic shall
				  submit to the Commissioner a written plan of correction of violations cited in
				  a deficiency statement prepared pursuant to
				  105 CMR
				  140.112 within ten calendar days after
				  receipt of the deficiency statement.
(B) 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
				  140.000 will be achieved. The timetable and the
				  compliance dates shall be consistent with achievement of compliance in the most
				  expeditious manner possible.
(C)
				  The Department shall review the plan of correction for compliance with the
				  requirements of 105 CMR 140.113(B) and will notify the licensee of either the
				  acceptance or rejection of the plan. An unacceptable plan must be amended and
				  resubmitted within five calendar days of the date of notice.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Licensing › Section 140.120 - Issuance of License

Current through Register 1525, July 5, 2024
Upon the approval of the application for a license, the
					 Department shall issue a clinic license to the applicant. Every license shall
					 state the name and address of the clinic if either differs from that of the
					 licensee; the period of licensure; the specific service(s) the clinic is
					 licensed to deliver; and the name and address of any satellite clinic. In the
					 case of a clinic providing mobile medical services, the license shall state the
					 name and address of the clinic, including address of the administrative
					 offices, if separate from the site(s) of service, and the name and address of
					 the host locations.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Licensing › Section 140.121 - Period of License

Current through Register 1525, July 5, 2024
(A) The Department
				  shall issue a clinic license for a period of two years.
(B) Provided a licensed clinic 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 140.000 - Licensure Of Clinics › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Licensing › Section 140.122 - Coverage of License

Current through Register 1525, July 5, 2024
A license is valid only for the premises and the specific
					 services authorized by the Department.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › Licensing › Section 140.123 - Posting of Clinic License

Current through Register 1525, July 5, 2024
The current license from the Department, or a copy thereof,
					 shall be posted in a conspicuous place in the clinic, and in any of its
					 satellites or mobile services sites.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › License Denial, Refusal to Renew, Revocation, and Suspension › Section 140.130 - Grounds for Suspension of License or Part of License

Current through Register 1525, July 5, 2024
The Commissioner may summarily suspend a clinic's license
					 or a part of its license covering a specific service or specific services, if
					 he or she decides the continuation in operation of the clinic or the specific
					 service(s) poses an imminent risk to the safety or proper health care of the
					 clinic's patients.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › License Denial, Refusal to Renew, Revocation, and Suspension › Section 140.131 - Grounds for Denial, Refusal to Renew or Revocation of a License or Part of License

Current through Register 1525, July 5, 2024
Each of the following, in and of itself, shall constitute
					 full and adequate grounds on which to deny, revoke, or refuse to renew a
					 license to operate a clinic in whole or in part with respect to a specific
					 service or specific services or a part or parts thereof:
(A) Lack of legal capacity to provide the
				  service(s) to be covered by a license.
(B) Lack of responsibility and suitability to
				  operate a clinic.
(C) Failure to
				  submit the required license fee.
(D) Violation of any state or federal statute
				  or regulation pertaining to operation of the clinic.
(E) Violation of any applicable provision of
				  105 CMR
				  140.000 and:
(1)
				  Failure to submit an acceptable plan of correction pursuant to
				  105 CMR
				  140.113; or
(2) Failure to remedy or correct a cited
				  violation by the date specified in the plan of correction as accepted or
				  modified by the Department.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › License Denial, Refusal to Renew, Revocation, and Suspension › Section 140.132 - Hearings

Current through Register 1525, July 5, 2024
(A)
Suspension of a
				  License
.
(1) Upon suspension of
				  a license or any part thereof, the Commissioner shall give the licensee written
				  notice thereof, stating the reason(s) for the suspension. The suspension shall
				  take effect immediately upon issuance of the notice.
(2) The Department shall initiate a hearing
				  pursuant to
				  801 CMR 1.00:
Standard
				  Adjudicatory Rules of Practice and Procedure
no later than 21 calendar
				  days after the effective date of the suspension.
(3) In cases of suspension of a license, the
				  hearing officer shall determine whether the Department has proved by a
				  preponderance of the evidence there existed, immediately prior to or at the
				  time of the suspension, an imminent risk to the safety or proper health care of
				  the clinic's patients.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › License Denial, Refusal to Renew, Revocation, and Suspension › Section 140.133 - Hearings: Scope of Review

Current through Register 1525, July 5, 2024
(A) Any hearing
				  officer conducting a hearing shall determine the suitability or responsibility
				  of any licensee or proposed licensee on request of the Department, whether or
				  not the applicant or licensee is licensed at the time the determination is
				  made.
(B) If a hearing officer
				  finds the licensee or proposed licensee is unsuitable or not responsible under
				  any single provision of
				  105
				  CMR 140.109, the hearing officer shall uphold
				  the decision of the Commissioner and finds the proposed licensee or licensee is
				  not suitable or responsible.
(C) If
				  the hearing officer finds any single ground for denial of, revocation of or
				  refusal to renew a license pursuant to
				  105
				  CMR 140.131 the hearing officer shall uphold
				  the decision of the Commissioner to deny, revoke or refuse to renew the
				  license.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › License Denial, Refusal to Renew, Revocation, and Suspension › Section 140.134 - Judicial Review of Agency Decision

Current through Register 1525, July 5, 2024
(A)
				  The decision of a hearing officer in any adjudicatory proceeding conducted
				  pursuant to
				  105
				  CMR 140.132 shall be reviewed by the
				  Commissioner. His or her decision upon this review shall constitute a final
				  agency decision in an adjudicatory proceeding subject to judicial review
				  pursuant to M.G.L. c. 30A, § 14.
(B) Any licensee or proposed licensee that
				  fails to exercise its right to an adjudicatory proceeding pursuant to
				  105
				  CMR 140.132 waives both its right to
				  administrative review by the Commissioner and its right to judicial review
				  pursuant to M.G.L. c. 30A, § 14.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › License Denial, Refusal to Renew, Revocation, and Suspension › Section 140.140 - Closing of a Clinic

Current through Register 1525, July 5, 2024
If a clinic intends to cease operation for a period greater
					 than seven consecutive days, it shall obtain written approval for a specified
					 period from the Commissioner at least 30 calendar days in advance of the
					 proposed closing. If circumstances are such that it is not possible to obtain
					 approval from the Commissioner prior to closing, such approval shall be
					 obtained within three business days of closing. Failure to obtain approval and
					 closure of the clinic for more than seven days shall constitute abandonment of
					 license.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › License Denial, Refusal to Renew, Revocation, and Suspension › Section 140.141 - Temporary Interruption of Service

Current through Register 1525, July 5, 2024
If a clinic finds any of the services required under
					 105 CMR
					 140.000 cannot be provided to patients for a temporary
					 period of time, the clinic shall report such a temporary interruption of
					 service to the Department as soon as the interruption of service is known to
					 the clinic.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart A - LICENSING AND OTHER ADMINISTRATIVE PROCEDURES › License Denial, Refusal to Renew, Revocation, and Suspension › Section 140.150 - Requirement for Personnel to Be Vaccinated against Influenza Virus and Coronavirus Disease 2019 (COVID-19) Caused by the Virus SARS-CoV-2

Current through Register 1525, July 5, 2024
(A)
Requirement for Personnel to
				  Be Vaccinated against Influenza Virus
.
(1)
Definitions
.
(a) For purposes of
				  105
				  CMR 140.150(A), personnel
				  means an individual or individuals who either work at or come to the licensed
				  clinic site and who are employed by or affiliated with the clinic, whether
				  directly, by contract with another entity, or as an independent contractor,
				  paid or unpaid including, but not limited to, employees, members of the
				  clinical staff, contract employees or staff, students, and volunteers whether
				  or not such individual(s) provides direct patient care.
(b) For purposes of
				  105
				  CMR 140.150(A), the
				  requirement for influenza vaccine or vaccination means immunization by either
				  influenza vaccine, inactivated or live; attenuated influenza vaccine including
				  seasonal influenza vaccine pursuant to
				  105
				  CMR 140.150(A)(2); and/or
				  other influenza vaccine pursuant to
				  105
				  CMR 140.150(A)(3).
(c) For purposes of
				  105
				  CMR 140.150(A), mitigation
				  measures mean measures that personnel who are exempt from vaccination take to
				  prevent viral infection and transmission.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart B - PHYSICAL ENVIRONMENT › Physical Plant › Section 140.201 - General Physical Environment

Current through Register 1525, July 5, 2024
Each clinic shall maintain its physical facilities in good
					 repair in a safe, comfortable and sanitary state, free from dirt, rubbish,
					 vermin, solid wastes, and objectionable odors.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart B - PHYSICAL ENVIRONMENT › Physical Plant › Section 140.202 - Reception and Office Areas

Current through Register 1525, July 5, 2024
Each clinic shall provide adequate space and equipment for
					 reception and waiting areas, for administrative and staff offices, and
					 appropriate storage for patient records whether paper or
					 electronic.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart B - PHYSICAL ENVIRONMENT › Physical Plant › Section 140.203 - Consultation, Examination and Treatment Areas

Current through Register 1525, July 5, 2024
Each clinic shall provide consultation, examination,
					 treatment and dressing areas appropriate to the services provided by the
					 clinic. Each clinic shall furnish and arrange such areas in a manner consistent
					 with their use and that safeguards the personal dignity and privacy (in terms
					 of both sight and sound) of the patient during interview, examination and
					 treatment. If separate consultation or interview rooms are not provided, the
					 treatment area shall have floor to ceiling partitions to ensure minimum sound
					 transmission.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart B - PHYSICAL ENVIRONMENT › Physical Plant › Section 140.204 - Clean Storage and Soiled Holding Areas

Current through Register 1525, July 5, 2024
Each clinic, except clinics providing only mental health
					 services or small clinics that do not have more than two examination rooms,
					 shall provide a clean supply storage room and a soiled workroom or soiled
					 holding room, that are apart from any examination, treatment or dressing area
					 as necessary for the services provided by the clinic to meet accepted standards
					 of practice. The clean storage room shall accommodate storage for clean
					 supplies. The soiled workroom area shall contain a work counter, a clinical
					 service sink, and if physically separate from the clean work area, a
					 handwashing sink with hot and cold water. If patient care does not involve
					 disposal of fluid waste, a soiled holding room equipped with a handwashing sink
					 with hot and cold water may be provided in
lieu
of a soiled
					 workroom.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart B - PHYSICAL ENVIRONMENT › Physical Plant › Section 140.205 - Handwashing and Toilet Facilities

Current through Register 1525, July 5, 2024
(A) Each
				  clinic shall provide conveniently located handwashing and toilet facilities
				  adequate for patients and personnel, as appropriate to the services provided by
				  the clinic.
(B) A soap dispenser,
				  disposable towels or electronic hand dryers, and a waste receptacle shall be
				  provided at each handwashing sink. Surgical scrub sink faucets shall be
				  provided with blade type operating handles, knee or foot controls.
(C) The clinic shall provide a handwashing
				  facility with hot and cold water and blade type operating handles or knee or
				  foot controls in each examination and treatment area.
(D) A limited service clinic or
				  mobile/portable unit located on or at the premises of another entity may share
				  toilet facilities with that entity.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart B - PHYSICAL ENVIRONMENT › Physical Plant › Section 140.206 - Utility Closet

Current through Register 1525, July 5, 2024
Each clinic shall provide one or more suitably located
					 utility closets equipped with a service sink or floor receptacle with hot and
					 cold water for emptying and cleaning housekeeping equipment. A limited services
					 clinic located on the premises of another entity may store supplies in a
					 utility closet or other designated space provided by entity provided that the
					 utility closet or other designated space is suitably located. Each utility
					 closet must have a door that locks. Each clinic shall label cleaning compounds
					 properly and clearly and store them in a utility closet or other locked
					 closet.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart B - PHYSICAL ENVIRONMENT › Physical Plant › Section 140.208 - Ventilation

Current through Register 1525, July 5, 2024
Each clinic shall provide all rooms that do not have direct
					 access to the outside, including toilets and soiled holding rooms, with
					 satisfactory mechanical ventilation.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart B - PHYSICAL ENVIRONMENT › Physical Plant › Section 140.209 - Accessibility to Individuals with Disabilities

Current through Register 1525, July 5, 2024
Clinic space, including satellites, mobile/portable units
					 and mental health outreach sites used for patients shall be accessible to
					 individuals with disabilities and shall comply with all federal, state and
					 local requirements for accessibility.
(A)
Mobile Medical
				  Services
. A mobile medical service shall meet the requirements set
				  forth in 105 CMR 140.209, either directly or through written arrangements for
				  shared service areas with the host locations.
(B) Any clinic located on the premises of
				  another entity shall be accessible through well marked corridors or aisles that
				  constitute an accessible route for individuals with disabilities. The clinic
				  shall be responsible for establishing a formal agreement with that entity for
				  the purpose of maintaining the accessible route free of obstructions at all
				  times.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart B - PHYSICAL ENVIRONMENT › Supplies and Equipment › Section 140.210 - Supplies and Equipment

Current through Register 1525, July 5, 2024
Each clinic shall have supplies and equipment appropriate
					 in quantity and type to the specific service(s) the clinic renders its patients
					 and adequate storage space for such supplies and equipment.