reglab/statecodes huggingface dataset:
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 143.000 - Standards Governing Cardiac Rehabilitation Treatment › Section 143.008 - Emergency Transfer and Referra l

Current through Register 1525, July 5, 2024
(A) Each
			 program shall have a written plan and procedure for the emergency transfer
			 including the transport of patients.
(B) Whenever a program refers a patient to
			 another facility, agency, or health care provider, with the written consent of
			 the patient, it shall send a copy of relevant portions ofthe program's record
			 on the patient to such facility, agency, or provider.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 143.000 - Standards Governing Cardiac Rehabilitation Treatment › Section 143.009 - Staff

Current through Register 1525, July 5, 2024
(A)
Staff Responsibilities and
			 Qualifications
.
(1)
Medical Director
.
(a) Each program shall employ, or otherwise
			 retain through a written agreement for services, a physician to serve as
			 medical director. The medical director shall be responsible for establishing
			 all medical protocols, policies and procedures, ensuring the achievement and
			 maintenance of quality standards of medical care, for overallpatient care
			 including participation inpatient treatment planning meetings and for
			 consultation with program personnel and referring physicians.
(b) The medical director shall be a physician
			 who is a board certified cardiologist or is board certified ininternal medicine
			 or family practice and shall have recent clinical experience in caring for
			 cardiac patients and experience in exercise testing and cardiac
			 rehabilitation.
(c) The medical
			 director shall be currently certified in advanced cardiac life support by the
			 American Heart Association.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 143.000 - Standards Governing Cardiac Rehabilitation Treatment › Section 143.010 - Treatment Planning

Current through Register 1525, July 5, 2024
(A) A written
			 treatment plan based on subjective and objective evaluations as documented in
			 the patient record shall be developed for each patient by a multidisciplinary
			 team of staff involved in the patient's care including the registered nurse and
			 medical director.
(B) The treatment
			 plan shall include a problem list and established patient goals that are based
			 on the individual patient's risk factor profile, functional capacity, potential
			 for improvement and the patient's personal goals.
(C) The written plan to achieve goals shall
			 include the specific intervention for each risk factor, and specific exercise
			 prescription based on recent symptom-limited exercise tolerance test.
(D) Treatment plans shall be reevaluated as
			 necessary but at least prior to advancement to Phase III.
(E) Upon completion of the Phase III Cardiac
			 Rehabilitation component, a discharge evaluation of the patient shall be made
			 by the nurse and/or program coordinator with the participation of the patient.
			 The discharge evaluation shall be based on subjective and objective
			 measurements, as documented in the patient's record. to identify progress
			 towards goals and to establish ongoing maintenance goals.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 143.000 - Standards Governing Cardiac Rehabilitation Treatment › Section 143.011 - Required Program Components/Services

Current through Register 1525, July 5, 2024
The following components/services shall be available to a
				cardiac rehabilitation participant either in a group or individual format and,
				where possible and appropriate, the family shall be included:
(A)
Participant/Family Education
			 Program Services
.
(1) Educational
			 programs shall be developed that address:
- The nature of cardiovascular disease
- Management of cardiovascular disease
- Prevention of cardiovascular disease
(2) All educational program offerings shall
			 have an established curriculum developed by a multi-disciplinary team comprised
			 of the appropriate professionals. The curriculum shall include objectives,
			 program outline, and plan for program evaluation.
(3) The education components/services shall
			 be based on the participant's problems and goals for the program.
(4) The program shall emphasize
			 self-assessment skills and self-help strategies.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 143.000 - Standards Governing Cardiac Rehabilitation Treatment › Section 143.012 - Patient Records

Current through Register 1525, July 5, 2024
(A) Each program
			 shall keep in one centralized location on its premises records indicating all
			 the services rendered to patients. Records shall contain sufficient information
			 to justify the services and to document the results accurately.
(B) Each patient shall have a single
			 integrated record. Each entry into each patient record shall be dated and
			 authenticated by the staff member making the entry, indicating name and title.
			 Each page of each patient's record shall have two unique forms of
			 identification. The record with respect to each patient shall include the
			 following:
(1) Patient's name, date of birth,
			 sex, home address and telephone number; name, address and telephone number of
			 referring physician and sponsor or responsible party, if any.
(2) Physician referral.
(3) Report of medical history and physical
			 examination upon initiation of therapeutic exercise program
			 component.
(4) Assessments,
i.e.
nursing assessment, psychosocial assessment. nutritional
			 assessment and musculo/skeletal assessments.
(5) Report of any diagnostic tests (exercise
			 tolerance test, Holter, echocardiogram. coronary catherization, blood tests.
			 etc.
(6) Discharge summary from
			 most recent hospitalization.
(7)
			 Report of most recent electrocardiogram.
(8) Informed consent for treatment.
(9) Date of each patient visit with program
			 staff.
(10) Progress notes which
			 include documentation of progress toward goals of the treatment plan.
(11) Documentation that progress reports were
			 communicated to the referring physician on a regular basis.
(12) Orders for any medication, test, or
			 treatment.
(13) Records of any
			 administration of medications, treatment, or therapy.
(14) Maximal symptom limited exercise
			 tolerance test prior to Phase III.
(15) Discharge evaluation.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 143.000 - Standards Governing Cardiac Rehabilitation Treatment › Section 143.013 - Required Facilities, Equipment and Safety Precautions and Procedures for Phase II and Phase III Programs

Current through Register 1525, July 5, 2024
Facilities and equipment necessary for the delivery of Phase II
				and Phase III components of the cardiac rehabilitation program shall be readily
				available for use.
(A)
Monitoring During Exercise Therapy Sessions During Phase II and
			 Phase III Programs
.
(1)
			 Continuous electrocardiographic monitoring equipment shall be available for use
			 with new participants and for periodic checks as deemed necessary by the
			 supervising personnel.
(2) The
			 medical director or his/her designated physician shall be present on the
			 premises during exercise therapy sessions unless the premises is covered by a
			 licensed hospital's medical emergency response team. The designated physician
			 shall be qualified to respond to cardiac emergencies and be currently certified
			 by the American Heart Association in Advanced Cardiac Life Support
			 (ACLS).
(3) At least one R.N.
			 certified in Advanced Cardiac Life Support by the American Heart Association
			 shall be in attendance at each exercise session in order to monitor
			 patients.
(4) Where Phase III
			 patients are exercising there shall be in attendance a minimum ratio of one
			 professional staff member to five patients and at least two staff members on
			 the premises.
(5) Participants
			 shall be instructed in a method to monitor their own exercise intensity (heart
			 rate, perceived exertion, symptoms).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 143.000 - Standards Governing Cardiac Rehabilitation Treatment › Section 143.014 - Serious Complaint Procedure

Current through Register 1525, July 5, 2024
Each program shall develop a written procedure that assures
				prompt and complete investigations of all serious complaints which are filed.
				The procedure shall include, at a minimum, the following provisions:
(A) Designation of a member of the program's
			 administration as the person responsible for overseeing the investigation of
			 serious complaints lodged;
(B)
			 Establishment of a reporting procedure which assures that the designated
			 administrator will receive within one day from staff, in writing, reports of
			 serious complaints;
(C) Development
			 by the designated administrator of a written process of investigation which
			 shall include the following:
(1) A process of
			 fact-gathering that he will utilize, including provision for interviewing of a
			 patient complainant;
(2) Creation
			 of a complaint file that includes the original report of complaint, progress
			 reports as investigation is carried out and outcome of investigation including
			 action taken, if any;
(3)
			 Notification of the complainant of the outcome of the investigation.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 143.000 - Standards Governing Cardiac Rehabilitation Treatment › Section 143.015 - Evaluation of Quality

Current through Register 1525, July 5, 2024
(A) Each program
			 shall establish an organized, comprehensive quality assurance program that is
			 adequate to regularly review and evaluate the quality and appropriateness of
			 care provided. The quality assurance program shall:
(1) be defined in writing;
(2) identify an individual to be responsible
			 for the implementation and continuity of the program;
(3) be re-evaluated at least annually;
			 and
(4) describe the mechanisms in
			 effect to identify and resolve problems.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Section 145.001 - Purpose

Current through Register 1525, July 5, 2024
The purpose of 105 CMR 145.000 is to provide for the protection
				of the health and safety of individuals receiving dialysis in out-of-hospital
				dialysis units.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Section 145.010 - Scope

Current through Register 1525, July 5, 2024
(A)
Procedures Permitted in an
			 Out-of-Hospital Dialysis Unit
. The unit shall provide dialysis
			 and/or home training on the premises as set forth in 105 CMR 145.050 through
			 145.980 and, also if permitted under the terms of its license, a home dialysis
			 program as set forth in
			 105 CMR
			 145.800 through
			 145.850.
			 Each Out-of-hospital Dialysis Unit shall comply with all applicable state and
			 federal statutes and regulations pertaining to health care
			 facilities.
(B)
Procedures Not Permitted in an Out-of-hospital Dialysis
			 Unit
. No unit shall provide acute dialysis or any other service
			 which under 105 CMR 130.000 may be provided only at a hospital, nor shall any
			 unit engage in any activity that is permitted only at long-term care facilities
			 or duties under 105 CMR 150.000.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Section 145.025 - Special Projects

Current through Register 1525, July 5, 2024
The Department will consider proposals for special projects for
				the innovative delivery of dialysis 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 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Section 145.099 - Waivers

Current through Register 1525, July 5, 2024
The Department may waive the applicability to a particular unit
				of one or more of the requirements set forth in 105 CMR 145.000 if:
(A) the Department finds that:
(1) compliance would cause undue hardship to
			 the unit;
(2) the unit is in
			 substantial compliance with the spirit of the requirement; and
(3) the unit's non-compliance does not
			 jeopardize the health or safety of its patients and does not limit the unit's
			 capacity to give adequate care; and
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Staffing › Section 145.100 - Governing Body

Current through Register 1525, July 5, 2024
The unit shall have an effective governing body or designated
				  person or persons with full legal authority and responsibility for the
				  governance and operation of the unit; establishing and implementing policies
				  regarding management and operations; oversight and accountability for the
				  quality assessment and performance improvement program; and the appointment of
				  a qualified administrator reporting to the governing body who shall be
				  responsible for the day-today operations.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Staffing › Section 145.110 - Administrator

Current through Register 1525, July 5, 2024
There shall be an administrator responsible for the
				  administration of the unit. The administrator must be physically present in the
				  unit as necessary to perform the duties of his or her
				  position.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Staffing › Section 145.120 - Medical Director

Current through Register 1525, July 5, 2024
There shall be a medical director who shall be responsible
				  for planning, organizing, coordinating and directing the unit's professional
				  services and for liaison with the affiliated institutions. The medical director
				  shall be physically present in the unit as necessary to carry out these
				  responsibilities.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Staffing › Section 145.121 - Qualifications of Medical Director

Current through Register 1525, July 5, 2024
The medical director shall be a physician who is certified,
				  or is an active candidate for certification, by the American Board of Internal
				  Medicine, and who has had at least one year of formal training in chronic renal
				  disease patient care or at least two years of experience in such care. In
				  either case, a significant portion of the required time shall have been spent
				  working in a dialysis unit that provides maintenance dialysis to patients with
				  chronic renal disease.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Staffing › Section 145.122 - Hours Staffed by Medical Director

Current through Register 1525, July 5, 2024
The medical director is not required to be a full time
				  employee; provided that he or she devotes sufficient time to ensure the proper
				  provision of professional services in accordance with the unit's by-laws and
				  105 CMR 145.000.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Staffing › Section 145.123 - Medical Director and Administrator

Current through Register 1525, July 5, 2024
The position of administrator and medical director may be
				  held by the same person; provided, that such a person is able to carry out both
				  responsibilities.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Staffing › Section 145.124 - Medical Staff

Current through Register 1525, July 5, 2024
The medical director, with the governing body, shall
				  establish criteria for granting privileges to licensed physicians or other
				  providers. The medical director shall review credentials of candidates for
				  medical staff membership and make recommendations to the governing body on the
				  initial appointment of candidates. The medical director must periodically
				  conduct appraisals of the members and make recommendations to the governing
				  body for reappointment of medical staff.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Staffing › Section 145.125 - Medical Staff By-laws

Current through Register 1525, July 5, 2024
The medical staff must operate pursuant to by-laws and rules
				  approved by the governing body. The by-laws must describe the organization of
				  the medical staff and set forth rules for its operation. The by-laws must
				  describe the procedure for applying for medical staff privileges, and the
				  qualifications to be met by a candidate in order for the candidate to be
				  appointed and/or reappointed to the medical staff by the governing
				  body.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Staffing › Section 145.130 - On-call Practitioner

Current through Register 1525, July 5, 2024
Whenever patients are undergoing treatment in the unit, a
				  physician, physician assistant or nurse practitioner shall be available on-call
				  to provide medical consultation and treatment of patients as needed. This
				  practitioner must be on the staff of the unit and must meet such requirements
				  for practice at the unit as the governing body may set forth in the unit
				  by-laws. The medical director may serve in this capacity when on the
				  premises.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Staffing › Section 145.140 - Nurse Manager

Current through Register 1525, July 5, 2024
Each unit shall have a nurse manager, who shall direct the
				  nursing staff in the provision of nursing services to
				  patients.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Staffing › Section 145.141 - Qualifications of Nurse Manager

Current through Register 1525, July 5, 2024
The nurse manager shall be a registered nurse with at least
				  12 months experience as a registered nurse and at least six months of
				  experience in dialysis treatment and chronic renal disease patient
				  care.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Staffing › Section 145.150 - Nursin g Personnel

Current through Register 1525, July 5, 2024
The unit shall have on duty sufficient direct care nursing
				  personnel to ensure that all patients undergoing dialysis have nursing care,
				  provided by registered nurses or licensed practical nurses trained in chronic
				  dialysis, available at all times at a ratio of at least one direct care staff
				  member to every three patients. If dialysis is performed in more than one room
				  of the unit, at least one nursing staff member shall be present at all times in
				  each room in which a patient is undergoing dialysis.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Staffing › Section 145.151 - Nursing Staff on Duty

Current through Register 1525, July 5, 2024
There shall be at least one registered nurse other than the
				  nurse manager on duty whenever patients are undergoing dialysis in the unit and
				  appropriately trained licensed nursing staff sufficient to meet the needs of
				  the patients. A registered nurse may give direct patient care provided that he
				  or she is also available to all patients for provision of any nursing care that
				  must by law be provided by a registered nurse.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Staffing › Section 145.152 - Qualifications of Nursing Personnel

Current through Register 1525, July 5, 2024
Nursing staff shall have training or experience in chronic
				  maintenance dialysis appropriate to their duties.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Staffing › Section 145.153 - Clinical Hemodialysis Technicians

Current through Register 1525, July 5, 2024
Clinical hemodialysis technicians trained in chronic dialysis
				  may assist the licensed nursing staff and be given responsibilities appropriate
				  to their training and experience. Such responsibilities may include starting
				  and ending dialysis, maintenance and use of dialysis equipment, surveillance of
				  the patient's condition during dialysis, and administration of agents
				  prescribed for regulation of blood clotting mechanisms as part of the dialysis
				  process.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Staffing › Section 145.160 - Counseling Services

Current through Register 1525, July 5, 2024
The unit shall make available to each patient, when needed,
				  either through its own resources or through affiliations under
				  105 CMR
				  145.300, or through another institution or
				  agency under written agreement, the following professional services: social
				  services, dietary counseling, mental health services and vocational
				  counseling.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Physical Environment › Section 145.200 - Location of Dialysis Unit

Current through Register 1525, July 5, 2024
The dialysis area shall be separate from other patient care
				  and administrative activities and shall not be located in an area that provides
				  access to such other areas.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Physical Environment › Section 145.210 - Space Requirements per Dialysis Station

Current through Register 1525, July 5, 2024
There shall be space between beds, in addition to that
				  necessary for associated equipment, sufficient to allow access to provide
				  needed care and services, prevent cross contamination, and to accommodate
				  medical emergency equipment and staff access to the patient by at least two
				  persons.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Physical Environment › Section 145.220 - Isolation Room

Current through Register 1525, July 5, 2024
A room shall be provided for isolation of potentially
				  infectious patients which shall be physically separated from any other dialysis
				  area, and shall be used in accordance with written policies approved by the
				  medical director and nurse manger that provide for infection control
				  procedures. The isolation room must be at least 110 square feet and must be
				  equipped with a handwashing sink.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Physical Environment › Section 145.225 - Home Training Room

Current through Register 1525, July 5, 2024
If home training is provided in the dialysis unit, a private
				  treatment area of at least 120 square feet shall be provided for patients who
				  are being trained to use dialysis equipment at home. The home training room
				  must contain a work counter, handwashing facilities and a separate drain for
				  fluid disposal.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Physical Environment › Section 145.230 - Dialysis Unit Support Spaces

Current through Register 1525, July 5, 2024
There shall be adequate provision for the following support
				  spaces in conveniently accessible locations:
(A) Space for patients' belongings;
(B) Toilet and handwashing facilities for
				patients;
(C) Toilet and
				handwashing facilities for staff;
(D) Examination room with handwashing
				facilities;
(E) Medication station
				with work counter and handwashing facilities;
(F) Clean supply storage room;
(G) Soiled workroom equipped with flushing
				rim sink, handwashing facilities, work counter, storage cabinets, waste
				receptacles, and soiled linen receptacle;
(H) Housekeeping room with floor receptor
				sink; and
(I) Reprocessing room. If
				dialyzers are reused, the unit must contain a reprocessing room sized to
				perform the required functions. The reprocessing room must provide for one-way
				flow of materials from soiled to clean. The reprocessing room must have
				provisions for refrigeration for temporary storage of dialyzers,
				decontamination/cleaning areas, sinks, a packaging area, and dialyzer storage
				cabinets.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Physical Environment › Section 145.240 - Sinks in Treatment Area

Current through Register 1525, July 5, 2024
The unit shall provide sufficient sinks with warm water and
				  soap available in the treatment area to facilitate
				  handwashing.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Physical Environment › Section 145.245 - Mechanical Ventilation

Current through Register 1525, July 5, 2024
The unit shall provide all rooms that do not have direct
				  access to the outside with satisfactory mechanical ventilation. The unit shall
				  provide mechanical exhaust ventilation in the isolation room, toilet rooms,
				  soiled workroom, housekeeping room and reprocessing room.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Physical Environment › Section 145.250 - Condition of Premises

Current through Register 1525, July 5, 2024
The premises shall be maintained in good repair and in
				  compliance with 105 CMR 410.000:
Minimum Standards of Fitness for Human
				  Habitation (State Sanitary Code: Chapter IT)
at all
				  times.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Physical Environment › Section 145.260 - Linen

Current through Register 1525, July 5, 2024
The unit shall make arrangements for the cleaning of linen
				  unless only disposable linen is used. Space and equipment shall be provided for
				  the handling and separate storage of soiled and clean linen.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Physical Environment › Section 145.270 - Water System

Current through Register 1525, July 5, 2024
Water and equipment used for dialysis must meet the water and
				  dialysate quality standards and equipment requirements as issued by the
				  Department in guidelines, based on standards issued by the Association for the
				  Advancement of Medical Instrumentation (AAMI).
(A)
Non-municipal Water
				System
. Where the water supply is not the municipal water system,
				the unit must obtain written approval of the source of the water supply from
				the local Board of Health.
(B)
Connections to Other Piping
. The water system shall
				have no connection to another piping system or to any fixture that presents a
				foreseeable risk of contamination of the water supply.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Physical Environment › Section 145.280 - Waste Disposal

Current through Register 1525, July 5, 2024
The unit shall provide appropriate equipment and employ
				  sanitary procedures for the collection, storage, and disposal of all solid
				  wastes, including garbage, rubbish and other refuse, biological wastes and
				  infectious materials.
(A)
Disposal of Infectious and Contaminated Waste
. The
				unit shall dispose of infectious or physically dangerous medical or biological
				waste in accordance with 105 CMR 480.000:
Minimum Requirements for the
				Management of Medical or Biological Waste (State Sanitary Code Chapter
				VIII).
The unit is responsible for the disposal of medical or
				biological waste generated on its licensed premises and for any such waste
				generated at any home dialysis program for which the unit provides supplies and
				services pursuant to
				105 CMR
				145.825 and
				105 CMR
				145.830.
(B)
Disposal of Non-contaminated
				Solid Wastes
. Non-contaminated solid wastes shall be collected,
				stored, and disposed of in a manner that will prevent the transmission of
				disease, not to create a nuisance or fire hazard and not to provide a breeding
				place for insects or rodents. Such solid wastes shall be stored, either indoors
				or out-doors, in a sanitary rodent-proof, fire-proof, non-absorbent,
				water-tight container.
(C)
Containers for Waste Disposal
. Containers used to
				collect or store solid wastes shall be emptied and cleaned as necessary to
				maintain a sanitary environment.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Physical Environment › Section 145.290 - Infection Control

Current through Register 1525, July 5, 2024
(A) The unit shall
				have and must follow written policies and procedures approved by the medical
				director and nurse manager for infection control within the unit.
(B) Such policies and procedures shall
				include, but need not be limited to the following:
(1) Standards and procedures for housekeeping
				and sanitation;
(2) Standards and
				procedures for aseptic techniques to be used;
(3) Procedures for surveillance, reporting,
				evaluating, and keeping records of infections among patients and personnel,
				with particular emphasis on sub-clinical hepatitis;
(4) A definition of hepatitis infection for
				the purpose of such surveillance, and specific indications of the need for and
				procedures to be used in isolation; and
(5) A policy pertaining to eating and
				drinking in the dialysis area or areas.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Physical Environment › Section 145.291 - Emergency Electrical Service

Current through Register 1525, July 5, 2024
(A) An emergency
				source of electrical power shall be provided on the premises of the dialysis
				facility.
(B) The source of the
				emergency electrical service shall be as follows: an emergency electrical
				generating set, including prime mover and generator, equipped with an automatic
				transfer switch, which will transfer within ten seconds, and shall be reserved
				exclusively for supplying the emergency electrical system. The generator set(s)
				shall have sufficient capacity and proper rating to meet the maximum expected
				demand of the Essential Electrical System at any one time.
(C) The emergency electrical services shall
				be provided to circuits as follows:
(1)
Lighting
.
(a) All
				task lighting, exitways, exit signs, exit directional signs, exit doorways,
				stairways, corridors, and lobby.
(b) Patient treatment rooms/cubicles, nursing
				station, medication preparation area, clean workroom, soiled workroom,
				equipment storage room, mechanical rooms and patient lounge area.
(c) Generator set location and switch gear
				location.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Affiliation Agreements › Section 145.300 - Affiliation Agreements Required

Current through Register 1525, July 5, 2024
The unit shall affiliate with licensed or approved hospitals,
				  other institutions, and agencies in such a manner as to ensure that its
				  patients, whether dialyzed at the unit or at home, can receive inpatient care,
				  routine and emergency dialysis and other hospital services, and emergency
				  medical care 24 hours a day, seven days a week. The agreement must ensure that
				  hospital services are available promptly to the unit's patients when needed and
				  include reasonable assurances that patients from the unit are accepted and
				  treated in emergencies.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Affiliation Agreements › Section 145.330 - Affiliation Agreement for Kidney Transplantation Service

Current through Register 1525, July 5, 2024
The unit shall have an affiliation agreement with at least
				  one hospital for kidney transplantation services, including:
(A) Tissue typing and matching, surgical
				transplant capability, kidney perfusion or other storage devices, immunology
				services directly or by affiliation;
(B) Availability of surgeons qualified by
				skill or training in the transplantation of kidneys;
(C) Availability of physicians qualified by
				skill or training in the management of post transplant patients.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Affiliation Agreements › Section 145.340 - Affiliation Agreement for Home Dialysis

Current through Register 1525, July 5, 2024
The unit shall have an affiliation agreement with at least
				  one hospital or out-of-hospital dialysis unit for provision of home dialysis
				  training program conforming to
				  105 CMR
				  145.800 through
				  145.850
				  if such a program is not provided by the unit.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Affiliation Agreements › Section 145.360 - Form of Affiliation Agreement

Current through Register 1525, July 5, 2024
Every affiliation agreement shall be in writing and shall set
				  forth the policies and procedures that will govern the referral and transfer of
				  patients between the unit and the licensed or approved hospital affiliated
				  institution or agency, including patient care referral
				  information.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Affiliation Agreements › Section 145.370 - Affiliation Agreements with Out-of-state Hospitals

Current through Register 1525, July 5, 2024
Units near to or accessible to hospitals in other states may
				  maintain affiliation with those hospitals forpurposes of
				  105 CMR
				  145.310,
				  145.320,
				  and
				  145.330
				  provided, that those hospitals have been approved to provide chronic
				  maintenance dialysis or transplantation services by the respective state's
				  designated authority or the federal government.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Patient Care › Section 145.400 - Admission Policies and Procedures

Current through Register 1525, July 5, 2024
A patient beginning dialysis or transferring from another
				  dialysis unit shall be admitted to the unit only after completion of a written
				  evaluation by a physician on staff at the out-of-hospital dialysis unit.
				  Written admission criteria must be developed to identify patients who require
				  initiation of dialysis in a hospital, prior to transfer to an out-of-hospital
				  dialysis unit.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Patient Care › Section 145.410 - Patient's Designated Practitioner

Current through Register 1525, July 5, 2024
The care of each patient at the unit shall be under the
				  supervision of a qualified physician, physician assistant, or nurse
				  practitioner of the patient's choice or acceptable to the patient. This
				  practitioner must be on the staff of the unit and must meet such requirements
				  for practice at the unit as the governing body may set forth in the unit
				  by-laws.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Patient Care › Section 145.420 - Annual Patient Evaluation

Current through Register 1525, July 5, 2024
Each patient shall be evaluated at least annually by an
				  interdisciplinary team composed of a physician, nurse, social worker, dietician
				  or others involved in the care of the patient as to the appropriateness and
				  effectiveness of the treatment received and the need for continuation of or
				  change in treatment. Such consideration shall include evaluation of the
				  appropriateness of at least home dialysis, self-dialysis and transplantation. A
				  record of each evaluation is to be made part of the patient's clinical
				  record.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Patient Care › Section 145.430 - Availability of Alternative Modes of Treatment

Current through Register 1525, July 5, 2024
All patients shall have access to alternative methods of
				  treatment of chronic renal disease such as home dialysis or transplantation.
				  Evidence of such access shall be available in the contents of the written
				  agreements with hospitals and the unit's own policies, including written
				  criteria for selection of patients for home dialysis.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Patient Care › Section 145.440 - Healthcare-associated Infection Data Collection, Submission and Reporting

Current through Register 1525, July 5, 2024
(A) Each free-standing dialysis unit shall:
(1) register with the NHSN; and
(2) grant access to the Department, in
				accordance with guidelines of the Department, to healthcare associated
				infection data elements reportable to the NHSN.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Patient Care › Section 145.450 - Serious Complaint Procedure

Current through Register 1525, July 5, 2024
Each unit shall develop a written procedure that ensures
				  prompt and complete investigations of all serious complaints that are filed
				  against the unit, employees of the unit or members of its professional staff.
				  The procedure shall include, at a minimum, the following provisions:
(A) Designation of a senior member of the
				unit administration as the person responsible for overseeing the investigation
				of serious complaints lodged against the unit, an employee, or a member of the
				professional staff;
(B)
				Establishment of a reporting procedure that ensures that the designated
				administrator will receive reports of serious complaints within one day from
				unit staff, in writing;
(C)
				Development by the designated administrator of a written process for
				investigation, which must include the following:
(1) A process of fact-gathering that he or
				she will utilize, including provision for interviewing of the complainant,
				patient, and relevant witnesses;
(2) Creation of a complaint file that
				includes the original report of complaint, progress reports as investigation is
				carried out and outcome of investigation including action taken, if any;
				and
(3) Notification of the
				complainant of the outcome of the investigation.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Patient Care › Section 145.455 - Serious Incident Reports

Current through Register 1525, July 5, 2024
(A) A unit shall
				immediately report to the Department, pursuant to Department guidelines, any of
				the following that occurs on premises covered by its license:
(1) death that is unanticipated, not related
				to the natural course of the patient's illness or underlying condition, or that
				is the result of an error or other incident as specified in guidelines of the
				Department;
(2) full or partial
				evacuation of the facility for any reason;
(3) fire;
(4) suicide;
(5) serious criminal acts;
(6) pending or actual strike action by its
				employees, and contingency plans for operation of the unit; or
(7) any other serious incident or accident as
				specified in guidelines of the Department.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Patient Care › Section 145.460 - Evaluation of Quality

Current through Register 1525, July 5, 2024
(A) Each unit shall
				establish an organized, comprehensive program that is adequate to regularly
				review and evaluate the quality of care provided. The program shall:
(1) be defined in writing and approved by the
				governing body;
(2) identify an
				individual to be responsible for the implementation and continuity of the
				program;
(3) be reevaluated at
				least monthly; and
(4) describe the
				mechanisms in effect to identify and resolve problems.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Patient Care › Section 145.470 - Pharmaceutical Services

Current through Register 1525, July 5, 2024
If controlled substances are stored and administered at the
				  facility directly to patients, the facility shall register with the Department
				  pursuant to M.G.L. c. 94C, § 7 and must comply with the provisions for
				  storage and administration of controlled substances pursuant to the
Federal Food, Drug and Cosmetics Act,
M.G.L. c. 94C, and 105
				  CMR 700.000:
Implementation of M.G.L. c.
				  94C.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Medical Records › Section 145.500 - Medical Records Required for Each Patient

Current through Register 1525, July 5, 2024
The unit must maintain a medical record for every patient
				  admitted to the out-of-hospital dialysis unit from the time of admission to the
				  time of discharge. The unit must maintain a current medical record for every
				  patient whose home dialysis is under the supervision of the
				  unit.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Medical Records › Section 145.505 - Record-keeping Facilities and Equipment

Current through Register 1525, July 5, 2024
The unit shall maintain facilities and equipment,
				  appropriately located and adequate to ensure the accurate processing, checking,
				  indexing, filing and prompt retrieval of all medical records and their safe
				  storage.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Medical Records › Section 145.515 - Responsibility for Completing Medical Record

Current through Register 1525, July 5, 2024
The unit must ensure the completion of a medical record. The
				  record shall be completed by a physician, physician assistant, or nurse
				  practitioner.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Medical Records › Section 145.520 - Practitioner's Orders

Current through Register 1525, July 5, 2024
Physician, physician assistant, or nurse practitioner orders
				  shall be legibly entered into the medical record and shall be dated and signed
				  by the physician, physician assistant, or nurse practitioner making the
				  order.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Medical Records › Section 145.525 - Telephone Orders

Current through Register 1525, July 5, 2024
Telephone orders shall be signed and dated by the physician,
				  physician assistant, or nurse practitioner within 72 hours.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 145.000 - Licensing Of Out-of-hospital Dialysis Units In Massachusetts › Medical Records › Section 145.530 - Responsibility for Keeping Medical Records

Current through Register 1525, July 5, 2024
The unit shall designate a person to be in charge of keeping
				  medical records in the manner prescribed in 105 CMR 145.000.