reglab/statecodes huggingface dataset:
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 140.211 - Maintenance and Sanitation of Supplies and Equipment

Current through Register 1525, July 5, 2024
Each clinic shall keep supplies and equipment safe,
					 sanitary and in good working condition as necessary for the services offered by
					 the clinic.
(A)
Shelf
				  Life
. The clinic shall discard supplies used for examination or
				  treatment of patients when beyond their shelf life.
(B)
Disinfection
.
				  The clinic shall disinfect diagnostic and therapeutic equipment after each use
				  in accordance with recognized standards of practice.
(C)
Sterilization
.
				  Each clinic shall sterilize after each use nondisposable equipment and supplies
				  requiring sterilization. Single use items shall not be reused. Sterilized
				  materials shall be packaged and labeled in a manner assuring sterility and
				  shall indicate the sterility dates.
(D)
Sterilization
				  Equipment
. Each clinic shall maintain sterilization equipment
				  adequate to the needs of the clinic, for the purpose of sterilizing equipment
				  and supplies as required or shall have an arrangement to obtain such services
				  from a source approved by the Commissioner. The clinic shall have a recognized
				  method of checking clinic sterilizer performance.
(E)
Safety of
				  Equipment
. The clinic shall establish and enforce a preventive
				  maintenance program to ensure all equipment is in safe working order. A
				  maintenance check shall be regularly performed on all mechanical and electronic
				  medical equipment. Electrified equipment shall be properly grounded and
				  calibrated consistent with manufacturer's recommendations.
(F)
Disposal of
				  Waste
. Each clinic shall ensure the safe disposal of hazardous and
				  infectious waste.
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 140.212 - Linen and Laundry

Current through Register 1525, July 5, 2024
If a clinic requires linen in its operation, it shall at
					 all times maintain a quantity of clean washable or disposable linen sufficient
					 for the needs of the clinic.
(A) The
				  clinic shall provide and maintain separate, suitable space and equipment for
				  the handling and storage of clean linen and soiled linen.
(B) The clinic shall store clean linen in a
				  closed closet, cabinet, or cart away from soiled areas.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart B - PHYSICAL ENVIRONMENT › Fire Protection › Section 140.220 - Emergency Plan

Current through Register 1525, July 5, 2024
Each clinic shall develop and maintain a written plan for
					 dealing with fire or other emergency. The clinic shall make a copy of the plan
					 available to all staff members. Each emergency plan shall specify persons to be
					 notified, locations of alarm signals and fire extinguisher, evacuation routes,
					 procedures for evacuating individuals with disabilities and nonambulatory
					 patients, and assignments of specific tasks and responsibilities. A copy of the
					 plan shall be posted in a conspicuous area of each separate clinic
					 premises.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart B - PHYSICAL ENVIRONMENT › Fire Protection › Section 140.221 - Fire Drills

Current through Register 1525, July 5, 2024
Each separate clinic premises shall conduct a fire drill at
					 least twice a year in each work shift, and such drills shall include the entire
					 staff. Documentation of such drills shall be available to the Commissioner for
					 review.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Administration › Section 140.301 - Administrative Records

Current through Register 1525, July 5, 2024
(A) Each clinic
				  shall maintain current, complete, and accurate administrative records in a safe
				  location. The clinic shall make all administrative records available promptly
				  to any agent of the Department seeking to determine compliance with
				  105 CMR
				  140.000.
(B) Administrative records shall include:
(1) Updated articles of organization and
				  bylaws, partnership agreement or trust instrument, as appropriate. The
				  documents shall specify the organizational structure of the governing body and
				  the methods of the selection of its members.
(2) Updated lists of the names and addresses
				  of the persons set forth in 105 CMR 104.102(B)(1)(a) through (d).
(3) Minutes of meetings of the governing body
				  and of the members.
(4) An
				  organizational chart for the entire organization.
(5) Written policies and procedures designed
				  to safeguard the health and safety of patients and staff. These policies and
				  procedures shall be reviewed and updated annually. At a minimum the policies
				  shall address:
(a) Selection of personnel and
				  the qualifications for each position. A job description for each position must
				  be included in the administrative records.
(b) Employee health policies ensuring
				  employees are free of communicable disease.
(c) Patient treatment criteria.
(d) The provision of emergency care and the
				  retention of emergency equipment appropriate to the clinic's patient
				  population.
(e) Obtaining informed
				  consent for surgical procedures and other treatment where required by
				  law.
(f) A policy for off-hour
				  coverage posted conspicuously in the clinic and any of its satellite clinics.
				  The policy must ensure compliance with
				  105 CMR
				  140.315(B).
(g) The disposal of hazardous and infectious
				  waste.
(h) Infection
				  control.
(i) Services that the
				  clinic provides.
(j) Smoking on the
				  premises.
(k) Procedures for
				  complying with laws and regulations relating to reportable diseases and
				  conditions.
(l) Procedures for
				  ensuring all patients of a clinic providing mobile services at host locations
				  are provided with written information clearly identifying the clinic, and not
				  the host location, as the licensed health care facility responsible for the
				  service provided.
(m) Policies and
				  procedures for documenting clinical supervision of health care staff by
				  licensed staff members.
(6) Personnel records for each employee,
				  including evidence of any required license or registration number;
				  documentation of any specialty certification, education and job
				  experience.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Administration › Section 140.302 - Patient Records

Current through Register 1525, July 5, 2024
(A) Each clinic
				  shall maintain centralized records documenting all the services rendered to
				  clinic patients. Records shall contain sufficient information to justify the
				  diagnosis(es) and treatment, and to document the results accurately. A mobile
				  medical service or mental health outreach program shall maintain patient
				  records as records of the clinic and not of the host locations or outreach
				  location(s).
(B) Each patient shall
				  have a single integrated record, except mental health, dental, substance use
				  disorder, and, upon approval of the Commissioner, other records, may be filed
				  separately, provided there is an effective cross-referencing system. Each entry
				  into each patient record shall be dated and authenticated by the staff member
				  making the entry, including the staff's name and title. Each page or each entry
				  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, and sponsor or responsible party if
				  any.
(2) Date of each patient visit
				  with clinic staff at the clinic, satellite clinic or at mental health outreach
				  sites.
(3) Medical or dental
				  history, as appropriate.
(4)
				  Diagnostic observations, evaluations, and therapeutic plans.
(5) Orders for any medication, test, or
				  treatment.
(6) Records of any
				  administration of medications, treatment, or therapy.
(7) Laboratory, radiology, and other
				  diagnostic reports.
(8) Progress
				  notes.
(9) Reports of any
				  consultations, special examinations, or procedures.
(10) Operative and anesthesia records for
				  surgical patients.
(11) Social
				  service reports.
(12) Referrals to
				  other agencies.
(13) Documentation
				  that informed consent has been obtained for surgical procedures and other
				  treatment where required by law and in accordance with
				  105 CMR
				  140.301(B)(5)(e).
(14) Discharge summary, when
				  appropriate.
(15) Documentation of
				  patient consent to release information to the receiving provider prior to or
				  upon patient transfer.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Administration › Section 140.303 - Posting of Notice of Patients' Rights

Current through Register 1525, July 5, 2024
Each clinic shall have visibly posted a notice, the
					 mandatory heading "NOTICE OF PATIENTS' RIGHTS" in block letters at least one
					 inch high and containing all the rights provided by M.G.L. c. 111, § 70E.
					 The notice shall be posted in at least one central area where all patients are
					 likely to see it. In addition, the clinic shall provide a written document
					 containing all the rights provided by M.G.L. c. 111, § 70E, in
					 understandable language and translated into the major languages spoken by the
					 clinic's patients, to each patient at his or her first visit to the
					 clinic.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Administration › Section 140.304 - Off-hour Coverage

Current through Register 1525, July 5, 2024
Each clinic shall make arrangements for the delivery of the
					 services it provides during the hours when it is not open, at least through an
					 answering service or, with the exception of clinics providing mental health
					 services, a recorded message referring patients to another provider of the same
					 services as geographically close as possible and open at those hours.
(1) Mental Health clinics must provide an
				  answering service after hours, in accordance with
				  105 CMR
				  140.520(E).
(2) A limited services clinic may provide a
				  taped message directing patients to a toll-free number that will enable the
				  patient to speak directly with a practitioner. These arrangements shall be
				  reflected in a written policy provided to all the clinic's patients.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Administration › Section 140.305 - Emergency Transfer

Current through Register 1525, July 5, 2024
(A) Each clinic
				  shall have a written policy addressing the procedures for calling 911 for
				  patients who need emergency treatment. A clinic is not precluded from entering
				  into agreements for inter-facility transport in nonemergency
				  situations.
(B) Each clinic
				  providing obstetrical services shall, prior to each patient's expected delivery
				  date, arrange for the patient to be admitted for delivery to a facility
				  licensed to perform deliveries. Unless the patient objects, the clinic shall
				  send a copy of the record of its obstetrical care of the patient to this
				  facility at the beginning of the patient's third trimester of pregnancy, and
				  update it as necessary.
(C)
				  Whenever a clinic refers a patient to another facility, agency, or health care
				  provider, unless the patient objects (except in the case of involuntary
				  commitment to a psychiatric hospital) it shall send a copy of relevant portions
				  of the clinic patient's record to such facility, agency, or provider.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Administration › Section 140.306 - Serious Complaint Procedure

Current through Register 1525, July 5, 2024
Each clinic shall develop a written procedure that ensuring
					 prompt and complete investigations of all serious complaints filed against the
					 clinic, employees of the clinic or members of its professional staff. The
					 procedure shall include, at a minimum, the following provisions:
(A) Designation of a senior member of the
				  clinic administration as the person responsible for overseeing the
				  investigation of serious complaints lodged against the clinic, an employee or
				  member of the professional staff;
(B) Establishment of a reporting procedure
				  ensuring the designated administrator will receive from clinical staff written
				  reports of serious complaints within one day of the clinic's receipt of the
				  serious complaint;
(C) Development
				  by the designated administrator of a written process of investigation, which
				  shall include the following:
(1) A process of
				  fact-gathering, 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;
(3) Notification of the
				  complainant of the outcome of the investigation.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Administration › Section 140.307 - Serious Incident Reports

Current through Register 1525, July 5, 2024
(A) A clinic
				  shall immediately report to the Department, pursuant to Department guidelines,
				  any of the following incidents occuring 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 clinic;
(7) reports on surgery-related and
				  anesthesia-related complications that result in serious morbidity or death of a
				  patient; or
(8) 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 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Administration › Section 140.308 - Ambulatory Surgery Center Reporting of Serious Reportable Events and Serious Adverse Drug Events

Current through Register 1525, July 5, 2024
(A)
Definitions
. For the purposes of 105 CMR 140.308.
National Quality Forum (NQF)
. The
					 not-for-profit membership organization created to lead national collaboration
					 to improve health and healthcare through measurement.
Preventable
. An event that could
					 have been anticipated and prepared for, but that occurs because of an error or
					 other system failure including, but not limited to, lack of adherence to best
					 practices, patient safety guidelines or established policies and
					 procedures.
Serious Adverse Drug Event (SADE)
.
					 Any untoward, preventable medical occurrence associated with the use of a
					 controlled substance, as defined in M.G.L. c. 94C, § 1, in humans that
					 results in any of the following outcomes:
(1) death;
(2) a life-threatening outcome;
(3) inpatient hospitalization or prolongation
				  of existing hospitalization;
(4) a
				  persistent or significant incapacity or substantial disruption of the ability
				  to conduct normal life functions; or
(5) a congenital anomaly or birth defect;
				  provided, however, that adverse medical occurrences directly associated with
				  the use of a controlled substance in humans that may not immediately result in
				  one of the outcomes listed in 105 CMR 140.308:
Serious Adverse Drug
				  Event (SADE)
(1) through (5), may be considered a serious adverse
				  drug event when they develop into or result in any of the outcomes listed in
				  105 CMR 140.308:
Serious Adverse Drug Event (SADE)
(1)
				  through (5).
Serious Reportable Event (SRE)
. An
					 event that occurs on premises covered by an ASC's license that results in an
					 adverse patient outcome, is clearly identifiable and measurable, has been
					 identified to be in a class of events that are largely preventable and harmful.
					 The Department will issue and maintain a list of SREs based on those events
					 included on the NQF's table of reportable events to which 105 CMR 140.308
					 applies.
Unambiguously the Result of a System
					 Failure
. Events determined by the ASC to result from:
(1) a failure to follow the ASC's policies
				  and procedures;
(2) inadequate or
				  nonexistent ASC policies and procedures; or
(3) inadequate system
				  design.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Administration › Section 140.309 - Ambulatory Surgery Center Healthcare-associated Infection Data Collection, Submission and Reporting

Current through Register 1525, July 5, 2024
(A)
Definitions
.
Healthcare-associated Infection
					 (HAI)
. A localized or systemic condition that results from an
					 adverse reaction to the presence of an infectious agent or its toxins
					 that:
(1) occurs in a patient in an
				  ambulatory surgery center (ASC); and
(2) was not present or incubating at the time
				  of the admission during which the reaction occurs;
(3) meets the criteria for a specific
				  infection as defined by the federal Centers for Disease Control and Prevention
				  and its National Healthcare Safety Network; and
(4) any additional elements as set forth in
				  administrative guidelines of the Deaprtment based on the National Healthcare
				  Safety Network.
National Healthcare Safety Network
					 (NHSN)
. The HAI tracking system operated by the federal Centers
					 for Disease Control and Prevention.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Staff › Section 140.310 - Clinic Administrator

Current through Register 1525, July 5, 2024
Each clinic shall designate a person to administer the
					 clinic and ensure that it complies with applicable statutes and regulations.
					 The clinic administrator must be physically present in the clinic as necessary
					 to perform the duties of his or her position. In his or her absence, a
					 professional staff person with the appropriate skills and training shall be
					 designated to act in his or her place.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Staff › Section 140.311 - Professional Services Director

Current through Register 1525, July 5, 2024
Each clinic shall designate a professional services
					 director, who shall be responsible for the clinical services provided at the
					 clinic. The professional services director must be a health care professional
					 possessing academic training and experience in direct patient care and shall be
					 qualified to direct the services provided by the clinic. The professional
					 services director must be physically present in the clinic as necessary to
					 oversee the professional services provided by the clinic. In his or her
					 absence, a professional staff person with the appropriate skills and training
					 shall be designated to act in his or her place.
If the clinic provides only surgical services, the
					 professional services director must be a surgeon.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Staff › Section 140.312 - Dual Appointment

Current through Register 1525, July 5, 2024
One person may serve as both clinic administrator and
					 professional services director if he or she meets the requirements for both
					 positions and can properly perform the duties of both
					 positions.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Staff › Section 140.313 - Physician Staff and Responsibility for Practice of Medicine

Current through Register 1525, July 5, 2024
(A) One or more physicians, as necessary,
				  shall provide, or supervise the provision of, all services involving the
				  practice of medicine.
(B) At least
				  one physician shall be present at the clinic whenever medical services are
				  provided, unless these services are provided pursuant to written protocols or
				  guidelines by a physician assistant or a nurse practicing in an expanded role
				  in accordance with the regulations of the appropriate registration
				  board.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Staff › Section 140.314 - Nursing Staff

Current through Register 1525, July 5, 2024
Each clinic shall retain a sufficient number of nurses
					 qualified to provide the nursing services necessary to the type of care the
					 clinic provides. These services shall be under the direction of a registered
					 nurse.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Staff › Section 140.315 - Health Care Staff

Current through Register 1525, July 5, 2024
(A) Each clinic
				  shall retain sufficient qualified professional health care staff to render
				  adequately and appropriately to each patient's needs the health services the
				  clinic is licensed to provide. The clinic shall ensure the qualifications of
				  its practitioners extend to appropriate training for the age range of patients
				  treated at the clinic. Professional health care staff shall be registered or
				  licensed as required by law. They shall comply with the regulations of their
				  registration or licensing boards, including all applicable supervision
				  requirements.
(B) At least one
				  professional health care staff member shall be present when patient health care
				  services are being provided in the clinic.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Staff › Section 140.316 - Nutrition Services

Current through Register 1525, July 5, 2024
If a clinic provides nutrition educational and counseling
					 services, a nutritionist must be retained on at least a part-time basis to
					 provide or supervise the service.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Staff › Section 140.317 - Social Services

Current through Register 1525, July 5, 2024
If a clinic provides social services, the clinic shall
					 retain on at least a part-time basis a social worker to provide or supervise
					 the service.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Staff › Section 140.318 - In-service Training for Health Care Staff

Current through Register 1525, July 5, 2024
There shall be a program of evidence-based, ongoing
					 in-service training that pertains to the service type(s) the clinic is licensed
					 to provide for all staff providing health care services. Such training may
					 include case studies and staff presentations provided within the facility or
					 may be obtained through participation in continuing education courses offered
					 outside the clinic.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Staff › Section 140.330 - Satellite Clinics

Current through Register 1525, July 5, 2024
No clinic licensed pursuant to
					 105 CMR
					 140.000 may provide services at a satellite, unless
					 the satellite meets, independently of its parent clinic, all the requirements
					 imposed on clinics by
					 105 CMR
					 140.000, except that a satellite clinic, as part of
					 the legal entity operating its parent clinic, shall have no separate articles
					 of organization, or bylaws or other charter of its own, and no separate
					 governing body, shareholders, members, or officers.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Clinic Pharmacy Services › Section 140.340 - Limitation on Dispensing and Administration of Controlled Substances

Current through Register 1525, July 5, 2024
A clinic pharmacy shall dispense or administer controlled
					 substances as defined by M.G.L. c. 94C, § 1 only to patients currently
					 under treatment at the clinic and employees of the clinic in accordance with
					 employee health policies, pursuant to the prescription of a clinic practitioner
					 legally authorized to issue prescriptions.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Clinic Pharmacy Services › Section 140.341 - Compliance with Applicable Laws and Regulations

Current through Register 1525, July 5, 2024
A clinic that maintains prescription medications on its
					 premises must register annually under the Controlled Substances Act with the
					 Drug Control Program pursuant to M.G.L. c. 94C, § 7 and operate in
					 accordance with all applicable federal, state, and local laws and
					 regulations.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Clinic Pharmacy Services › Section 140.342 - Clinic Pharmacy Staffing

Current through Register 1525, July 5, 2024
(A)
Pharmacy Director
. The clinic shall employ a
				  registered pharmacist to direct and manage the clinic pharmacy.
(B)
Registered
				  Pharmacist
. A registered pharmacist shall be on duty whenever the
				  clinic pharmacy is open.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Clinic Pharmacy Services › Section 140.343 - Clinic Pharmacy Policies

Current through Register 1525, July 5, 2024
(A) Each clinic
				  that operates a clinic pharmacy shall maintain a pharmacy policy manual
				  describing in writing the organization of the clinic pharmacy and the specific
				  services it provides.
(B) The
				  policy manual shall be reviewed annually by the pharmacy and therapeutics
				  committee and include at least those policies required under
				  105 CMR
				  140.344(B).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Clinic Pharmacy Services › Section 140.344 - Pharmacy and Therapeutics Committee

Current through Register 1525, July 5, 2024
Each clinic that maintains and operates a clinic pharmacy
					 shall establish a pharmacy and therapeutics committee composed of members of
					 the medical staff, the pharmacy director, the clinic administrator or his or
					 her representative, members of the nursing staff and other personnel as
					 appropriate to the services the clinic provides.
(A) The committee shall serve as an advisory
				  group to the medical staff and pharmacy director on matters concerning drugs
				  used in the clinic. The committee shall review all reports of medication errors
				  and adverse drug reactions. The committee shall meet at least quarterly and
				  shall keep minutes of its meetings.
(B) The committee shall develop written
				  policies for safe and effective drug therapy, distribution, control and use.
				  The clinic shall adopt policies developed and recommended by the committee,
				  including at least:
(1) a therapeutic guide
				  and recommended drug list for use in the clinic, which shall be reviewed not
				  less than once a year;
(2)
				  standards concerning the use and control of investigational drugs and drug
				  research programs;
(3) procedures
				  for access to drugs for use by the clinic when the pharmacy is closed, and a
				  list of persons who are allowed such access;
(4) methods to ensure appropriateness of
				  continuing drug therapy;
(5)
				  procedures for reporting and preventing medication errors and reporting adverse
				  drug reactions;
(6) methods to
				  ensure compliance with M.G.L. c. 112, § 12D, and
				  105 CMR 720.000:
List of Interchangeable Drug Products
,
				  105 CMR 721.000:
Standards for Prescription Format and Security in
				  Massachusetts
and
				  105 CMR 722.000:
Dispensing Procedures for Clinic and Hospital
				  Pharmacies
;
(7) a drug
				  recall procedure that can be readily implemented; and
(8) systems for the control and
				  accountability of all drugs including, but not limited to, procedures for
				  reporting theft, loss or suspected tampering of any controlled substance, in
				  accordance with
				  105 CMR
				  700.005(D). Such policies
				  must ensure compliance with up to date standards for product quality, security
				  and record keeping systems.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Clinic Pharmacy Services › Section 140.345 - Drug Handling and Administration

Current through Register 1525, July 5, 2024
A clinic with a pharmacy shall comply with the requirements
					 of 105 CMR 140.345 and
					 105 CMR 722.000:
Dispensing Procedures for Clinic and Hospital Pharmacies
,
					 which shall be included in the clinic pharmacy policy manual.
(A)
Administration
.
				  All drugs administered to patients in the clinic shall be administered by
				  appropriately licensed personnel.
(B)
Access to Emergency
				  Drugs
. The clinic shall maintain an emergency medication kit. The
				  emergency medication kit shall be kept in a separate sealed container when not
				  in use. Drugs requiring refrigeration shall be kept in a separate sealed
				  container under proper refrigeration when not in use. Each emergency medication
				  kit shall be prepared, packaged and sealed by a registered pharmacist or
				  pharmacy intern under the direct supervision of a registered pharmacist, and
				  shall contain a list of contents on the outside cover and within the box. After
				  an emergency medication kit has been opened, it shall be inspected, restocked
				  and resealed by a registered pharmacist or a pharmacy intern under the direct
				  supervision of a registered pharmacist the next day the clinic pharmacy is
				  open.
(C)
Drugs for
				  External Use; Poisons
. The clinic pharmacy shall label drugs for
				  external use and poisons as such, and shall keep such drugs separate from other
				  medications.
(D)
Labeling
. All drugs shall be labeled adequately,
				  including cautionary statements as appropriate. Clinic staff shall return drug
				  containers with illegible, incomplete, damaged, worn, soiled, or missing labels
				  to the clinic pharmacy, and the pharmacy staff shall dispose of such containers
				  and drugs appropriately.
(E)
Outdated Drugs
. As drugs become outdated, the clinic
				  pharmacy shall eliminate them from its stock in accordance with clinic policy.
				  All drugs shall be destroyed in accordance with applicable state and federal
				  laws.
(F)
Prescriptions
. All prescriptions shall be issued to
				  patients and transmitted to a pharmacy on an Electronic Prescribing System, as
				  defined in
				  105 CMR 721.000:
Standards for Prescription Format and Security in
				  Massachusetts
, unless an ePrescribing exception, listed in
				  105 CMR
				  721.070:
ePrescribing
				  Exceptions,
is applicable.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Clinic Pharmacy Services › Section 140.346 - Facilities and Equipment

Current through Register 1525, July 5, 2024
(A)
Drug
				  Preparation Areas
. The clinic pharmacy shall have adequate and
				  properly controlled drug preparation areas, wherever drugs are prepared for
				  administration or dispensing. The areas shall have adequate lighting,
				  ventilation and temperature controls, and be located such that personnel will
				  not be interrupted when handling drugs.
(B)
Storage of
				  Drugs
. Drugs shall be stored under proper conditions to ensure
				  product stability and security. Drug storage facilities shall be locked.
				  Schedule II drugs shall be kept double locked.
(C)
Reference
				  Materials
. The clinic pharmacy shall maintain and make available
				  up-to-date pharmaceutical reference materials to furnish the clinic pharmacy
				  and other staff with adequate information concerning drugs.
(D)
Antidote Information; Poison
				  Control Center
. The clinic pharmacy shall maintain authoritative
				  and current antidote information, readily available in the pharmacy for
				  emergency reference, along with the telephone number of the regional poison
				  control center.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Clinic Pharmacy Services › Section 140.347 - Pharmacy Services by Clinics without Clinic Pharmacies

Current through Register 1525, July 5, 2024
If the clinic does not maintain a clinic pharmacy, but
					 drugs are stored and administered at the clinic directly to patients, the
					 clinic shall comply with the requirements of 105 CMR 140.347 and
					 105 CMR 700.000:
Implementation of M.G.L. c. 94C
.
(A)
Compliance with Federal and
				  State Law
. The clinic must register annually under the Controlled
				  Substances Act with the Department pursuant to M.G.L. c. 94C, § 7 and
				  shall comply with all applicable federal, state, and local drug laws and
				  regulations.
(B)
Record
				  System
. The clinic professional services director or his or her
				  designee shall be responsible for ensuring a record system that maintains
				  control over the requisitioning and administration of controlled substances.
				  The recordkeeping system shall comply with all federal and state laws and
				  regulations.
(C)
Storage of Drugs
. Drugs shall be stored under proper
				  conditions to ensure product stability and security. Drug storage facilities
				  shall be locked. Schedule II drugs shall be kept double locked.
(D)
Medications for External
				  Use
. The clinic shall accurately label each medication for
				  external use as such, and shall store such medications separately from
				  medications for internal use.
(E)
Outdated Drugs
. Outdated drugs shall be eliminated
				  from the clinic's stock in accordance with clinic policies. All drugs shall be
				  destroyed in accordance with applicable state and federal laws.
(F)
Administration of
				  Medications
. All drugs administered directly to patients in the
				  clinic shall be administered by appropriately licensed personnel. Prescriptions
				  shall be issued for all drugs not administered within the clinic. However,
				  drugs may be dispensed by a prescribing practitioner for immediate treatment
				  until such time as a prescription can be filled at a pharmacy.
(G)
Labeling
. All
				  drugs shall be adequately and distinctly labeled.
(H)
Reference
				  Source
. The clinic shall maintain and make available up-to-date
				  pharmaceutical reference materials for reference by clinic staff.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Clinical Laboratory Services › Section 140.350 - Approval of In-house Clinical Laboratory Services

Current through Register 1525, July 5, 2024
In-house clinical laboratory services offered by a clinic
					 are subject to clinical laboratory approval as set forth in
					 105 CMR 180.000:
The Operation and Licensing of Clinical Laboratories,
and 42
					 CFR 493, except that laboratory director qualifications must, at a minimum,
					 meet CLIA requirements and any Department administrative
					 guidelines.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Clinical Laboratory Services › Section 140.351 - Contracting for Outside Clinical Laboratory Services

Current through Register 1525, July 5, 2024
(A) A clinic may enter into a written
				  contract for the provision of all or part of its clinical laboratory services
				  with a laboratory independent of the clinic that is licensed, approved or
				  certified by the appropriate federal or state agencies.
(B) The clinic must have detailed written
				  statements of policy on procedures for the collection, transport, and handling
				  of specimens referred to such an outside laboratory. These written statements
				  shall be available for review by the Commissioner.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Diagnostic Radiology › Section 140.360 - Compliance with Applicable Laws and Regulations

Current through Register 1525, July 5, 2024
Each clinic that provides diagnostic radiology shall comply
					 with M.G.L. c. 111, § 5B, and
					 105
					 CMR 120.000:
The Control of
					 Radiation
. Clinics providing such service must register with the
					 Department's Division of Radiation Control pursuant to
					 105 CMR
					 120.100. The provisions of
					 105 CMR 140.361
					 through
					 140.362
					 do not apply to a clinic that is licensed to provide dental services
					 only.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Diagnostic Radiology › Section 140.361 - Radiologist

Current through Register 1525, July 5, 2024
Each clinic that provides diagnostic radiology shall
					 retain, at least on a consulting basis, a board certified or board qualified
					 radiologist to meet the needs of the clinic. The radiologist shall be
					 responsible for the proper performance of the radiological
					 services.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Diagnostic Radiology › Section 140.362 - Radiologic Technologist

Current through Register 1525, July 5, 2024
Diagnostic radiology procedures that are not performed or
					 directly supervised at all times by a board certified or board qualified
					 radiologist shall be performed only by radiologic technologists licensed
					 pursuant to M.G.L. c. 111, § 5L, and
					 105 CMR 125.000:
Licensing of Radiologic Technologists
.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Diagnostic Radiology › Section 140.363 - Diagnostic Radiology Facilities

Current through Register 1525, July 5, 2024
Each clinic providing diagnostic radiology services shall
					 provide the following, in adequate and suitable form for the services
					 provided:
(1) X-ray equipment
				  appropriate to the diagnostic services offered by the clinic;
(2) at least one radiographic room of
				  adequate size for the equipment provided;
(3) space for preparation of barium mixtures,
				  if applicable; and
(4) adequate
				  storage space for files of X-ray films.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Diagnostic Radiology › Section 140.364 - Mammography Facility - Licensure

Current through Register 1525, July 5, 2024
Each clinic operating a mammography facility, as defined in
					 M.G.L. c. 111, § 5Q, and
					 105 CMR 127.000:
Licensing of Mammography Facilities
, shall obtain and maintain
					 a license issued pursuant to
					 105 CMR
					 127.000.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Diagnostic Radiology › Section 140.370 - Evaluation of Quality

Current through Register 1525, July 5, 2024
(A) Each clinic
				  shall establish an organized, comprehensive program adequate to regularly
				  review and evaluate the quality of care provided. The program shall:
(1) be defined in writing and approved by its
				  governing body;
(2) identify an
				  individual to be responsible for the implementation and continuity of the
				  program;
(3) be reevaluated 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 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Diagnostic Radiology › Section 140.380 - Procurement, Storage and Administration of Blood

Current through Register 1525, July 5, 2024
Each clinic that administers human whole blood and/or its
					 components and/or derivatives in transfusion shall meet the following
					 requirements:
(A) The clinic shall have
				  a current, effective agreement with a blood bank licensed by the Department
				  that meets the requirements of
				  105 CMR 135.000:
Use of Blood, Blood Components, and Derivatives for the Purpose of
				  Transfusion
.
(B) The
				  clinic shall obtain blood from a licensed blood bank immediately prior to its
				  administration. All blood so obtained shall be identified, stored, handled, and
				  administered in accordance with the requirements of
				  105 CMR 135.000:
Use of Blood, Blood Components, and Derivatives for the Purpose of
				  Transfusion
.
(C) The
				  clinic shall develop policies and procedures specific to all aspects of the
				  procurement, storage and administration of blood. These policies and procedures
				  at a minimum shall address patient selection and consent, the requirements for
				  explicit written order(s) from a physician, nurse practitioner, or physician
				  assistant the prompt availability of physicians in the event of an emergency,
				  the proper identification of the patient, the qualifications and training of
				  the registered nurse administering the blood, the monitoring of patients
				  undergoing transfusion, including the required observation time following
				  administration, procedures to follow in the event of a transfusion reaction and
				  recordkeeping requirements.
(D)
				  Prior to the initiation of a program to procure, store and administer blood for
				  transfusion, each clinic shall inform the Department in writing and receive
				  Department approval. Department approval shall be based on compliance with 105
				  CMR 140.380(A), (B) and (C) and other relevant clinic licensure
				  regulations.
(E) Except as provided
				  for in
				  105 CMR
				  140.614, transfusion of blood shall not be
				  permitted as part of the surgical service of a clinic.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart C - GENERAL REQUIREMENTS › Diagnostic Radiology › Section 140.381 - Autologous Hematopoietic Progenitor/Stem Cell Transplantation

Current through Register 1525, July 5, 2024
Autologous hematopoietic progenitor/stem cell
					 transplantation may be performed in a separately licensed freestanding clinic
					 if the clinic transplantation services are a formal part of a hospital-based
					 hematopoietic progenitor/ stem cell transplantation program. The clinic must
					 have a written, current collaboration agreement with the hospital-based
					 hematopoietic progenitor/stem cell transplantation program. The collaboration
					 agreement shall, at a minimum:
(1)
				  Describe the services to be provided at the clinic site;
(2) Describe the support services available
				  at the hospital site, with particular attention to availability for patient
				  care consultation by all members of the multidisciplinary team including, but
				  not limited to, physicians, nurses, nutritionists, social workers, physical
				  therapists and psychologists;
(3)
				  Describe the oversight responsibilities of the hospital;
(4) Identify a physician or nurse coordinator
				  on-site at the clinic;
(5) Describe
				  the quality assessment and assurance programs for transplantation at the clinic
				  site, with particular attention to how the assessment data is used to improve
				  services and how the data is integrated in both the clinic's and the hospital's
				  quality assurance programs; and (6) Be signed and dated by the Hospital
				  Administrator, Hospital Vice President of Nursing or Clinical Services,
				  Hospital Hematopoietic Progenitor/Stem Cell Transplantation Program Director,
				  Clinic Medical Director and Clinic Physician or Nurse Coordinator.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart D - DENTAL SERVICES › Section 140.400 - Applicability of 105 CMR 140.401 through 140.405

Current through Register 1525, July 5, 2024
The requirements of
				  105 CMR
				  140.401 through
				  140.404 are applicable
				  to clinics subject to Department licensure to provide dental
				  services.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart D - DENTAL SERVICES › Section 140.401 - Minimum Dental Services

Current through Register 1525, July 5, 2024
A clinic offering dental services shall at a minimum provide
				  oral diagnostic services; services to maintain oral health and prevent oral
				  disease; basic restorative dental care; and services to relieve dental pain and
				  infection.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Subpart D - DENTAL SERVICES › Section 140.402 - Dental Services Staff

Current through Register 1525, July 5, 2024
(A) Each clinic
				shall be staffed with one or more dentists as necessary to provide or supervise
				the provision of dental services.
(B) Dental hygienists employed by the clinic
				shall be registered by the Board under M.G.L. c. 112, § 51.
(C) Dental assistants employed shall be
				licensed pursuant to M.G.L. c. 112, § 51½ and shall meet the
				requirements of
				234
				CMR 4.11:
Initial Dental Assistant
				Licensure for EFDA-, CA- and FTDA-qualified Individuals
and
				234
				CMR 4.12:
Initial Licensure for
				Dental Assistants Trained on the Job
.