reglab/statecodes huggingface dataset:
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 125 - REGULATIONS GOVERNING THE LICENSING OF AMBULATORY SURGICAL FACILITIES › Chapter 2 - LICENSURE PROCEDURES › Section 144-125-2.D - Failure to Comply with Applicable Laws and Rules

Current through 2024-29, July 17, 2024
The following shall apply for failure to comply with
					 applicable laws and rules:
2.D.1. When
				  an applicant fails to comply with applicable laws and rules, the Department
				  shall refuse to issue or renew the license.
2.D.2. If, at the expiration of a full
				  license, or during the term of a full license, the facility fails to comply
				  with applicable laws and rules and, in the judgement of the commissioner, the
				  best interest of the public will be so served, the Department may issue a
				  conditional license or change a full license to a conditional
				  license.
2.D.3. Any license issued
				  under this chapter may be suspended or revoked for violation of applicable laws
				  and rules which prohibit the committing, permitting, aiding or abetting of any
				  illegal practices in the providers' operations or when the conduct or practices
				  of the provider are detrimental to the welfare, of persons to whom Ambulatory
				  Surgical Facilities are provided. When the Department has reasonable grounds to
				  believe that a license shall be suspended or revoked, it shall file a complaint
				  with the Administration Court in accordance with Title 4, 1153 or commence
				  administrative action pursuant to the Maine Administrative Procedure Act, Title
				  5, Section 8001
et seq
., as appropriate to the
				  circumstances.
2.D.4. Receivership
				  Pursuant to
				   22 M.R.S.A.,
				  Section7931
et seq
., the
				  Department may petition the Superior Court to appoint a receiver to operate
				  Ambulatory Surgical Facility in the following circumstances:
1. When the Ambulatory Surgical Facility
				  intends to close, but has not arranged at least thirty (30) days prior to
				  closure for the orderly transfer of its patients/clients;
2. When an emergency exists in an Ambulatory
				  Surgical Facility which threatens the health, security or welfare of
				  patient/clients;
3. When the
				  Ambulatory Surgical Facility is in substantial or habitual violation of the
				  standards of health, safety or patient/client care established under State or
				  Federal regulations to the detriment of the welfare of the
				  patient/client.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 125 - REGULATIONS GOVERNING THE LICENSING OF AMBULATORY SURGICAL FACILITIES › Chapter 2 - LICENSURE PROCEDURES › Section 144-125-2.E - Appeals

Current through 2024-29, July 17, 2024
Any person aggrieved by the Department's decision to take
					 any of the following actions may request an administrative hearing as provided
					 by the Maine Administrative Procedure Act, Title 5, Section 8001
et
					 seq
.
2.E.1. Issue a
				  conditional license;
2.E.2. Amend
				  or modify a license;
2.E.3. Refuse
				  to issue or renew a full license.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 125 - REGULATIONS GOVERNING THE LICENSING OF AMBULATORY SURGICAL FACILITIES › Chapter 3 - ADMINISTRATIVE REQUIREMENTS › Section 144-125-3.A - Fees

Current through 2024-29, July 17, 2024
Each application for a license under this chapter shall be
					 accompanied by the fee established by the Department. No such fee may be
					 refunded. The fee shall not exceed $500 annually. All fees received by the
					 Department under this chapter shall be paid into the State Treasury to the
					 credit of the Department for the purpose of reducing the costs of carrying out
					 this chapter.
3.A.1. Each application
				  under this chapter shall be accompanied by the following fee(s):
a. A basic fee of $250 for all licensure
				  applicants;
b. An additional fee
				  based on an agency's total full time equivalent staff. This additional fee will
				  be calculated as follows:
0-10 total full time equivalent employees $100
10-25 total full time equivalent employees $175
25 or more full time equivalent employees $250
c. In order to calculate the
				  number of full time equivalent employees, a standard of at least 37 1/2 hours
				  per week will be utilized. All full and part time employees of the Ambulatory
				  Surgical Facility, including administrative, business clerical and direct
				  service providers, will be included in the calculation of an agency's full time
				  equivalency figure.
d. All licenses
				  issued shall be renewed annually upon payment of the appropriate fee and
				  demonstration of continued compliance with these rules and regulations. The
				  renewal fee shall be calculated utilizing information supplied in the
				  Ambulatory Surgical Facility's annual statistical report and/or renewal
				  application.
e. No such fee shall
				  be refunded.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 125 - REGULATIONS GOVERNING THE LICENSING OF AMBULATORY SURGICAL FACILITIES › Chapter 3 - ADMINISTRATIVE REQUIREMENTS › Section 144-125-3.B - Right of Entry and Inspection

Current through 2024-29, July 17, 2024
The Department and any duly designated officer or employee
					 thereof shall have the right to enter upon and into the premises of any
					 Ambulatory Surgical Facility provider who has applied for a license or who is
					 licensed pursuant to this chapter at any reasonable time and, upon demand, have
					 the right to inspect and copy books, accounts, papers, records and other
					 documents in order to determine the state of compliance with this chapter and
					 any rules in force pursuant thereto. The right of reasonable entry and
					 inspection shall extend to any premises and documents of providers whom the
					 Department has reason to believe are providing Ambulatory Surgical Facility
					 services without a license, but no such entry or inspection may be unreasonable
					 or made without the permission of the owner or person in charge thereof, unless
					 a warrant is first obtained from a court of competent jurisdiction authorizing
					 that entry or inspection.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 125 - REGULATIONS GOVERNING THE LICENSING OF AMBULATORY SURGICAL FACILITIES › Chapter 3 - ADMINISTRATIVE REQUIREMENTS › Section 144-125-3.C - Requirements

Current through 2024-29, July 17, 2024
3.C.1. No Ambulatory Surgical Facility may
				  provide services without receiving a license from the Department, authorizing
				  such services or operation.
3.C.2.
				  The applicant shall comply with all applicable Maine Statutes and rules and
				  regulations.
3.C.3. No Ambulatory
				  Surgical Facility shall accept any remuneration for delivering ambulatory
				  surgical facilities without having first secured a license authorizing its
				  operation in accordance with these regulations.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 125 - REGULATIONS GOVERNING THE LICENSING OF AMBULATORY SURGICAL FACILITIES › Chapter 3 - ADMINISTRATIVE REQUIREMENTS › Section 144-125-3.D - Application Procedures

Current through 2024-29, July 17, 2024
3.D.1. Filing of
				  Application
Any person, partnership, association or corporation
					 desiring a license to engage in ambulatory surgical facilities shall, prior to
					 the commencement of such operation, file an application with the Department.
					 Applications submitted on behalf of a corporation or association shall be made
					 by any two officers thereof or by its administrator. (All applicants shall
					 comply with these rules and regulations.)
3.D.2. Contents of Application
Each application shall contain:
a. The name by which the Ambulatory Surgical
				  Facility is to be legally known and the name under which it shall be doing
				  business.
b. A description of all
				  facilities utilized by the Ambulatory Surgical Facility. This will include the
				  address(es), telephone number(s) and name(s) of owner(s) of all buildings
				  utilized by the Ambulatory Surgical Facility.
c. A listing of surgical procedures provided
				  by the agency.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 125 - REGULATIONS GOVERNING THE LICENSING OF AMBULATORY SURGICAL FACILITIES › Chapter 3 - ADMINISTRATIVE REQUIREMENTS › Section 144-125-3.E - Certificate of Need

Current through 2024-29, July 17, 2024
3.E.1. Any
				  applicant desiring a license to engage in providing Ambulatory Surgical
				  Facility services shall assure the Department that their facility does not need
				  a Certificate of Need as determined by submitting a letter of intent as
				  described in the Procedures Manual Maine Certificate of Need Act to:
Director, Division of Program Analysis and
					 Development
Office of Health Planning and Development
35 Anthony Avenue, 11 State House Station
Augusta, Maine 04333
3.E.2. All Ambulatory Surgical Facilities
				  shall submit a letter of intent to the Director, Division of Program Analysis
				  and Development, as a part of the initial Ambulatory Surgical Facility process
				  for the agency. This letter should state:
a.
				  The types of Ambulatory Surgical Facility services provided by the facility;
				  and
b. The date that each of these
				  Ambulatory Surgical Facility services was initiated by the agency.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 125 - REGULATIONS GOVERNING THE LICENSING OF AMBULATORY SURGICAL FACILITIES › Chapter 3 - ADMINISTRATIVE REQUIREMENTS › Section 144-125-3.F - Compliance with All Local Ordinances

Current through 2024-29, July 17, 2024
The applicant shall submit a letter from the appropriate
					 municipal official(s) that demonstrates compliance with all local ordinances
					 relative to zoning and building code requirements.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 125 - REGULATIONS GOVERNING THE LICENSING OF AMBULATORY SURGICAL FACILITIES › Chapter 3 - ADMINISTRATIVE REQUIREMENTS › Section 144-125-3.G - Posting of License

Current through 2024-29, July 17, 2024
The license granted by the Department shall be
					 conspicuously posted in an area where business is conducted/coordinated for
					 Ambulatory Surgical Facilities.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 125 - REGULATIONS GOVERNING THE LICENSING OF AMBULATORY SURGICAL FACILITIES › Chapter 3 - ADMINISTRATIVE REQUIREMENTS › Section 144-125-3.H - Identification Badges

Current through 2024-29, July 17, 2024
All health care provider employees providing direct patient
					 care must wear an identification badge that includes at least the following
					 information:
1. Name of health care
				  provider;
2. Employee's first name
				  with first initial of the employee's last name;
Eff. April 1, 2000
3. Initials identifying the employee's
				  registration/ licensure/certification;
4. Employee's job title. Health care
				  providers will develop policies and procedures which will define the situations
				  and criteria when the wearing of an identification badge will be
				  waived.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 125 - REGULATIONS GOVERNING THE LICENSING OF AMBULATORY SURGICAL FACILITIES › Chapter 4 - COMPLIANCE REQUIREMENTS › Section 144-125-4.A - Compliance with State Licensure Laws

Current through 2024-29, July 17, 2024
The Ambulatory Surgical Facility must comply with all State
					 licensure requirements
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 125 - REGULATIONS GOVERNING THE LICENSING OF AMBULATORY SURGICAL FACILITIES › Chapter 4 - COMPLIANCE REQUIREMENTS › Section 144-125-4.C - Governing Body and Management

Current through 2024-29, July 17, 2024
The Ambulatory Surgical Facility must have a governing body
					 that assumes full legal responsibility for determining, implementing and
					 monitoring policies governing the Ambulatory Surgical Facility's total
					 operation and for ensuring that these policies are administered so as to
					 provide quality health care in a safe environment. When services are provided
					 through a contract with an outside resource, the Ambulatory Surgical Facility
					 must assure that these services are provided in a safe and effective
					 manner.
4.C.1. Hospitalization
The Ambulatory Surgical Facility must have an effective
					 procedure for the immediate transfer, to a hospital, of patients requiring
					 emergency care beyond the capabilities of the Ambulatory Surgical Facility.
					 This hospital must be a local, Medicare participating hospital or a local,
					 non-participating hospital that meets the requirements for payment for
					 emergency services under 42 Code of Federal Regulations, Section 482.2. The
					 Ambulatory Surgical Facility must have a written transfer agreement with such a
					 hospital, or all physicians performing surgery in the Ambulatory Surgical
					 Facility must have admitting privileges at such a hospital. The Ambulatory
					 Surgical Facility must also have a written agreement with an ambulance
					 service.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 125 - REGULATIONS GOVERNING THE LICENSING OF AMBULATORY SURGICAL FACILITIES › Chapter 4 - COMPLIANCE REQUIREMENTS › Section 144-125-4.D - Surgical Services

Current through 2024-29, July 17, 2024
Surgical procedures must be performed in a safe manner by
					 qualified physicians who have been granted clinical privileges by the governing
					 body of the Ambulatory Surgical Facility in accordance with approved policies
					 and procedures of the Ambulatory Surgical Facility.
4.D.1. Anesthetic Risk and Evaluation
A physician must examine the patient immediately before
					 surgery to evaluate the risk of anesthesia and of the procedure to be
					 performed. Before discharge from the Ambulatory Surgical Facility, each patient
					 must be evaluated by a physician for proper anesthesia recovery.
4.D.2. Administration of
				  Anesthesia
Anesthetics must be administered by only:
a. A qualified anesthesiologist; or
b. A physician qualified to administer
				  anesthesia, a certified nurse anesthetist, a supervised trainee in an approved
				  educational program. In those cases where a non-physician administers the
				  anesthesia, the anesthetist must be under the supervision of the operating
				  physician.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 125 - REGULATIONS GOVERNING THE LICENSING OF AMBULATORY SURGICAL FACILITIES › Chapter 4 - COMPLIANCE REQUIREMENTS › Section 144-125-4.E - Evaluation of Quality

Current through 2024-29, July 17, 2024
The Ambulatory Surgical Facility, with the active
					 participation of the medical staff, must conduct an ongoing, comprehensive
					 self-assessment of the quality of care provided, including medical necessity of
					 procedures performed and appropriateness of care, and use findings, when
					 appropriate, in the revision of center policies and consideration of clinical
					 privileges.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 125 - REGULATIONS GOVERNING THE LICENSING OF AMBULATORY SURGICAL FACILITIES › Chapter 4 - COMPLIANCE REQUIREMENTS › Section 144-125-4.F - Environment

Current through 2024-29, July 17, 2024
The Ambulatory Surgical Facility must have a safe and
					 sanitary environment, properly constructed, equipped and maintained to protect
					 the health and safety of patients.
4.F.l. Physical Environment
The Ambulatory Surgical Facility must provide a functional
					 and sanitary environment for the provision of surgical services.
a. Each operating room must be designed and
				  equipped so that the types of surgery conducted can be performed in a manner
				  that protects the lives and assures the physical safety of all individuals in
				  the area.
b. The Ambulatory
				  Surgical Facility must have a separate recovery room and waiting
				  area.
c. The Ambulatory Surgical
				  Facility must establish a program for identifying and preventing infections,
				  maintaining a sanitary environment and reporting the results to appropriate
				  authorities.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 125 - REGULATIONS GOVERNING THE LICENSING OF AMBULATORY SURGICAL FACILITIES › Chapter 4 - COMPLIANCE REQUIREMENTS › Section 144-125-4.G - Medical Staff

Current through 2024-29, July 17, 2024
The medical staff of the Ambulatory Surgical Facility must
					 be accountable to the governing body.
4.G.I. Membership and Clinical Privileges
Members of the medical staff must be legally and
					 professionally qualified for the positions to which they are appointed and for
					 the performance of privileges granted. The Ambulatory Surgical Facility grants
					 privileges in accordance with recommendations from qualified medical
					 personnel.
4.G.2.
				  Reappraisals
Medical staff privileges must be periodically reappraised
					 by the Ambulatory Surgical Facility. The scope of procedures performed in the
					 Ambulatory Surgical Facility must be periodically reviewed and amended as
					 appropriate.
4.G.3. Other
				  Practitioners
If the Ambulatory Surgical Facility assigns patient care
					 responsibilities to practitioners other than physicians, it must have
					 established policies and procedures, approved by the governing body, for
					 overseeing and evaluating their clinical activities.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 125 - REGULATIONS GOVERNING THE LICENSING OF AMBULATORY SURGICAL FACILITIES › Chapter 4 - COMPLIANCE REQUIREMENTS › Section 144-125-4.H - Nursing Services

Current through 2024-29, July 17, 2024
The nursing services of Ambulatory Surgical Facilities must
					 be directed and staffed to assure that the nursing needs of all patients are
					 met.
4.H.1. Organization and Staffing
Patient care responsibilities must be delineated for all
					 nursing and service personnel. Nursing services must be provided in accordance
					 with recognized standards of practice. There must be a registered nurse
					 available for emergency treatment whenever there is a patient in the Ambulatory
					 Surgical Facility.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 125 - REGULATIONS GOVERNING THE LICENSING OF AMBULATORY SURGICAL FACILITIES › Chapter 4 - COMPLIANCE REQUIREMENTS › Section 144-125-4.I - Medical Records

Current through 2024-29, July 17, 2024
The Ambulatory Surgical Facility must maintain complete,
					 comprehensive and accurate medical records to ensure adequate patient
					 care.
4.I.1. Organization
The Ambulatory Surgical Facility must develop and maintain
					 a system for the proper collection, storage and use of patient records.
4.I.2. Form and Content of Record
The Ambulatory Surgical Facility must maintain a medical
					 record for each patient. Every record must be accurate, legible and promptly
					 completed. Medical records must include at least the following:
a. Patient identification
b. Significant medical history and results of
				  physical examination
c.
				  Pre-operative diagnostic studies (entered before surgery, if
				  performed).
d. Findings and
				  techniques of the operation, including a pathologist's report on all times
				  removed during surgery, except those exempted by the governing body
e. Any allergies and abnormal drug
				  reactions
f. Entries related to
				  anesthesia administration
g.
				  Documentation of properly executed informed patient consent
h. Discharge diagnosis.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 125 - REGULATIONS GOVERNING THE LICENSING OF AMBULATORY SURGICAL FACILITIES › Chapter 4 - COMPLIANCE REQUIREMENTS › Section 144-125-4.J - Pharmaceutical Services

Current through 2024-29, July 17, 2024
The Ambulatory Surgical Facility must provide drugs and
					 biologicals in a safe and effective manner, in accordance with accepted
					 professional practice, and under the direction of an individual designated
					 responsible for pharmaceutical services.
4.J.I. Administration of Drugs
Drugs must be prepared and administered according to
					 established policies and acceptable standards of practice.
a. Adverse reactions must be reported to the
				  physician responsible for the patient and must be documented in the
				  record.
b. Blood and blood products
				  must be administered by only physicians or registered nurses.
c. Orders given orally for drugs and
				  biologicals must be followed by a written order, signed by the prescribing
				  physician.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 125 - REGULATIONS GOVERNING THE LICENSING OF AMBULATORY SURGICAL FACILITIES › Chapter 4 - COMPLIANCE REQUIREMENTS › Section 144-125-4.K - Laboratory and Radiologic Services

Current through 2024-29, July 17, 2024
The Ambulatory Surgical Facility must have procedures for
					 obtaining routine and emergency laboratory and radiologic services, from
					 Medicare approved facilities, to meet the needs of patients.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 126 - REGULATIONS GOVERNING THE LICENSING AND FUNCTIONING OF END STAGE RENAL DISEASE UNITS/FACILITIES › Chapter 2 - LICENSING APPLICATION PROCEDURES › Section 144-126-2.A - Requirements

Current through 2024-29, July 17, 2024
2.A.1. No ESRD Facility may provide ESRD
				  services without receiving a license from the Department, authorizing such
				  services or operation.
2.A.2. No
				  ESRD Facility shall accept any remuneration for delivering ESRD services
				  without having first secured a license authorizing its operation in accordance
				  with these regulations.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 126 - REGULATIONS GOVERNING THE LICENSING AND FUNCTIONING OF END STAGE RENAL DISEASE UNITS/FACILITIES › Chapter 2 - LICENSING APPLICATION PROCEDURES › Section 144-126-2.B - Application Procedure

Current through 2024-29, July 17, 2024
2.B.1. Filing of
				  Application
Any person, partnership, association or corporation
					 desiring a license to engage in ESRD services shall, prior to the commencement
					 of such operation, file an application with the Department. Applications
					 submitted on behalf of a corporation or association shall be made by any two
					 (2) officers thereof or by its administrator. All applicants shall comply with
					 the rules and regulations adopted pursuant to Title 22 M.R.S.A., c. 412.,
					 § 2041 and § 2042. The applicant shall comply with all other
					 applicable Maine Statutes and rules and regulations.
2.B.2. Contents of Application
Each application shall contain:
a. The name by which the ESRD Facility is to
				  be legally known and the name under which it shall be doing business;
b. A description of all facilities utilized
				  by the ESRD Facility. This will include the address(es), telephone number(s)
				  and name of owner(s) of all buildings utilized by the ESRD Facility;
c. A listing of ESRD services provided by the
				  ESRD Facility;
d. For proprietary
				  corporations: the full name and address of each person, firm or corporation
				  having (directly or indirectly) an ownership interest of 5% or more in the
				  facility;
e. For business entities
				  with one owner or business partnerships: the full name and address of the owner
				  or each partner;
f. For
				  not-for-profit organizations: the full name and address of the President of the
				  Board of Directors or appropriate municipal government
				  representative;
g. The name, home
				  address, home telephone number and office telephone numbers of the individual
				  designated by the applicant as the administrator of the ESRD
				  Facility;
h. The name of the
				  Director of Nursing;
i. The number
				  of full-time equivalent staff.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 126 - REGULATIONS GOVERNING THE LICENSING AND FUNCTIONING OF END STAGE RENAL DISEASE UNITS/FACILITIES › Chapter 2 - LICENSING APPLICATION PROCEDURES › Section 144-126-2.C - Fees

Current through 2024-29, July 17, 2024
2.C.1. Each initial application under this
				  chapter shall be accompanied by a $450.00 fee. Thereafter an annual fee of
				  $450.00.
2.C.2. No such fee shall
				  be refunded.
2.C.3. Change in
				  Ownership of a ESRD Facility
a. No license
				  shall be assigned or transferred.
b. At least thirty (30) days advance written
				  notice shall be given to the Division of Licensing and Certification, in the
				  Bureau of Medical Services, Department of Human Services, prior to the transfer
				  of ownership of any ESRD Facility.
c. Each application for a license from a new
				  owner shall be accompanied by a statement from the previous owner or his duly
				  authorized representative concerning the change of ownership. In lieu of this
				  statement, a copy of the deed or other validating document shall be submitted.
				  In addition, an application fee of $450.00 shall be submitted to the
				  Department. When the ownership of an ESRD Facility changes, upon receipt of a
				  completed application and fee, the Department may issue a license.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 126 - REGULATIONS GOVERNING THE LICENSING AND FUNCTIONING OF END STAGE RENAL DISEASE UNITS/FACILITIES › Chapter 2 - LICENSING APPLICATION PROCEDURES › Section 144-126-2.D - Compliance with All Local, State and Federal Regulations

Current through 2024-29, July 17, 2024
2.D.1. The applicant shall submit a letter
				  from the appropriate municipal official(s) that demonstrates compliance with
				  all local ordinances relative to zoning and building codes and a certificate of
				  occupancy, if appropriate, which includes electrical and life safety code
				  compliance.
2.D.2. The applicant
				  will submit proof of a Clinical Laboratory number, if appropriate, under the
				  Clinical Laboratory Improvement Amendments of 1988.
2.D.3. The applicant will submit proof of a
				  Department of Environmental Protection number, if appropriate, regarding
				  disposition of biomedical waste.
2.D.4. A person who enters an ESRD program
				  must be given information about their rights to formulate an advance
				  directive.
2.D.5. The applicant
				  shall meet all applicable requirements developed by the Association for the
				  Advance of Medical Instrumentation (AAMI).
2.D.6. The applicant must be in compliance
				  with all Federal Conditions of Participation listed at 42 Code of Federal
				  Regulations, Section 405.2100
et seq
.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 126 - REGULATIONS GOVERNING THE LICENSING AND FUNCTIONING OF END STAGE RENAL DISEASE UNITS/FACILITIES › Chapter 2 - LICENSING APPLICATION PROCEDURES › Section 144-126-2.E - Posting of License

Current through 2024-29, July 17, 2024
The license granted by the Department shall be
					 conspicuously posted in an area where business is conducted/coordinated for
					 ESRD Facilities.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 126 - REGULATIONS GOVERNING THE LICENSING AND FUNCTIONING OF END STAGE RENAL DISEASE UNITS/FACILITIES › Chapter 2 - LICENSING APPLICATION PROCEDURES › Section 144-126-2.F - Changes in Licensed ESRD Services

Current through 2024-29, July 17, 2024
2.F.1. Each
				  ESRD Facility will notify the Division of Licensing and Certification, in
				  writing, of any changes in:
a.
				  Ownership;
b. Scope and nature of
				  services provided;
c. Relocation or
				  change of business address and telephone;
d. Administrator; and
e. Deeming.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 126 - REGULATIONS GOVERNING THE LICENSING AND FUNCTIONING OF END STAGE RENAL DISEASE UNITS/FACILITIES › Chapter 2 - LICENSING APPLICATION PROCEDURES › Section 144-126-2.G - Types of Licenses Issued

Current through 2024-29, July 17, 2024
The Department will issue the following types of licenses
					 to ESRD Facilities:
2.G.1.
				  Provisional License-The Department will issue a provisional license to all ESRD
				  Facilities who have completed an application and paid the initial annual fee.
				  The Department will, thereafter, issue a full or conditional license upon
				  onsite review of the ESRD Facility.
2.G.2. Full License-Effective for the period
				  of twelve (12) months to an applicant who complies with all applicable laws and
				  rules.
2.G.3. Conditional
				  License-Effective for a specific period not to exceed one (1) year to an
				  applicant who has not fully complied with all applicable laws and rules, and in
				  the judgment of the Commissioner, the best interest of the public would be so
				  served by issuing a conditional license.
a.
				  The decision to grant a conditional license can be made by the Department at
				  the time of application for an initial license, at the expiration of a full
				  license or during the term of a full license.
b. The conditional license shall specify when
				  and what corrections shall be made during the term of the conditional
				  license.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 126 - REGULATIONS GOVERNING THE LICENSING AND FUNCTIONING OF END STAGE RENAL DISEASE UNITS/FACILITIES › Chapter 2 - LICENSING APPLICATION PROCEDURES › Section 144-126-2.H - Specifications of License

Current through 2024-29, July 17, 2024
2.H.1. Each license
				  issued by the Department shall identify:
a.
				  The name of the ESRD Facility;
b.
				  The name of the Administrator;
c.
				  The geographical location;
d. The
				  type of ESRD services provided;
e.
				  The period of licensure and date of licensure expiration; and
f. The date issued and the type of
				  license.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 126 - REGULATIONS GOVERNING THE LICENSING AND FUNCTIONING OF END STAGE RENAL DISEASE UNITS/FACILITIES › Chapter 3 - LOSS OF, RENEWAL, AND CONDITIONAL LICENSES › Section 144-126-3.A - Refusal to Issue a License

Current through 2024-29, July 17, 2024
3.A.1. The
				  Department may refuse to issue a license to the applicant if it finds that any
				  or all of the following conditions exist :
a.
				  The Department finds that the information submitted in the application is
				  incorrect or incomplete;
b. The
				  applicant does not meet all requirements of these laws and
				  regulations;
c. The applicant has
				  violated applicable laws and rules and regulations, and the Department finds
				  that these practices of the facility are detrimental to the welfare of persons
				  to whom ESRD services are provided.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 126 - REGULATIONS GOVERNING THE LICENSING AND FUNCTIONING OF END STAGE RENAL DISEASE UNITS/FACILITIES › Chapter 3 - LOSS OF, RENEWAL, AND CONDITIONAL LICENSES › Section 144-126-3.B - Right of Entry and Inspection

Current through 2024-29, July 17, 2024
3.B.1. Any duly
				  designated employee of the Department shall have the right to enter upon and
				  into the premises of any ESRD Facility who has applied for a license or who is
				  licensed pursuant to these rules and regulations. The Department can inspect
				  relevant Facility documents to determine whether the Facility is in compliance
				  with these rules and regulations. The right of entry and inspection shall
				  extend to any premises and documents of Facilities whom the Department has
				  reason to believe are providing ESRD services without a license. Such entries
				  or inspections shall be made with permission of the owner or person in charge
				  unless a warrant is first obtained from the District Court authorizing that
				  entry or inspection (
				   22 M.R.S.A.
				  §2148 ). Any duly designated employee of
				  the Department, with the permission of the patient, may also make patient home
				  visits at his/her discretion.
3.B.2. Application for licensure, whether
				  initial or renewal, shall constitute permission for entry into, and survey of,
				  an ESRD Facility by authorized licensing authority representatives at
				  reasonable times, during pendency of the application and, if licensed, during
				  the licensure period.
3.B.3.
				  Surveys may be unannounced at the sole discretion of the Division of Licensing
				  and Certification. All complaint investigations will be unannounced.
3.B.4. Upon receipt of a Statement of
				  Deficiencies from the Division of Licensing and Certification, the licensee or
				  his/her representative will be required to submit a Plan of Correction to the
				  Division of Licensing and Certification within ten (10) working days of receipt
				  stating how the ESRD Facility intends to correct each violation noted and the
				  expected date of completion.
3.B.5.
				  The Division of Licensing and Certification may, at its sole discretion, accept
				  the Plan of Correction as written, or request modification of the Plan by the
				  licensee.
3.B.6. Regardless of the
				  term of the license, the Department shall monitor for continued compliance with
				  applicable rules and regulations.
3.B.7. Inspections
The Department shall inspect the ESRD Facility for one (1)
					 year, except that State inspections need not be performed during a year when a
					 Medicare certification survey is performed.
3.B.8. An ESRD Facility is not eligible for
				  licensure or renewal of licensure, unless the ESRD Facility has had a Medicare
				  survey or a State licensure survey within the previous year.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 126 - REGULATIONS GOVERNING THE LICENSING AND FUNCTIONING OF END STAGE RENAL DISEASE UNITS/FACILITIES › Chapter 3 - LOSS OF, RENEWAL, AND CONDITIONAL LICENSES › Section 144-126-3.C - Renewal of License

Current through 2024-29, July 17, 2024
3.C.1. The
				  Department will send the ESRD Facility a renewal application at least fifty
				  (50) calendar days prior to the expiration of the ESRD license. This
				  application shall be completed and submitted to the Department at least twenty
				  (20) calendar days prior to the expiration of the license. The Department shall
				  review the renewal application to ensure that it is consistent with these rules
				  and regulations.
3.C.2. Based upon
				  its review, Department staff will inform the ESRD Facility of its decision to:
a. Renew the license for one (1)
				  year;
b. Issue the ESRD Facility a
				  conditional license; or
c. Refuse
				  to issue the applicant a new license.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 126 - REGULATIONS GOVERNING THE LICENSING AND FUNCTIONING OF END STAGE RENAL DISEASE UNITS/FACILITIES › Chapter 3 - LOSS OF, RENEWAL, AND CONDITIONAL LICENSES › Section 144-126-3.D - Suspension or Revocation of License

Current through 2024-29, July 17, 2024
3.D.1.
				  The Department may recommend suspension or revocation of any license issued,
				  pursuant to 22 M.R.S.A. c. 412. § 2041 and § 2042, for violation of
				  applicable laws and rules committing, permitting, aiding or abetting any
				  illegal practices in the operation of the provider or conduct or practices
				  detrimental to the welfare of persons to whom ESRD services are
				  provided.
3.D.2. When the
				  Department believes that a license should be suspended or revoked, it shall
				  file a complaint with the Administrative Court in accordance with Title
				   4 M.R.S.A.,
				  §§1151
et seq
. or
				  the Maine Administrative Procedure Act, Title
				   5
				  M.R.S.A. §10051
et
				  seq
.
3.D.3. Upon
				  suspension or revocation of a license, the license shall be immediately
				  surrendered to the Department.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 126 - REGULATIONS GOVERNING THE LICENSING AND FUNCTIONING OF END STAGE RENAL DISEASE UNITS/FACILITIES › Chapter 3 - LOSS OF, RENEWAL, AND CONDITIONAL LICENSES › Section 144-126-3.E - Emergency Revocation or Suspension of License

Current through 2024-29, July 17, 2024
Whenever the Department determines that the health or
					 physical safety of a person is in immediate jeopardy, action in accordance with
					  5 M.R.S.A., §9051
et seq
. would fail to respond to a known risk, the Department,
					 in accordance with
					  4 MRSA,
					 §1153, may file a complaint with the
					 Administrative Court to temporarily revoke or suspend an ESRD Facility
					 license.
3.E.1. Receivership Pursuant
				  to
				   22 M.R.S.A.,
				  Section7931, the Department may petition the
				  Superior Court to appoint a receiver to operate an End Stage Renal Disease
				  Unit/Facility in the following circumstances:
a. When the End Stage Renal Disease
				  Unit/Facility intends to close, but has not arranged at least thirty (30) days
				  prior to closure for the orderly transfer of its patient/clients;
b. When an emergency exists in an End Stage
				  Renal Disease Unit/Facility which threatens the health, security or welfare of
				  patient/clients;
c. When the End
				  Stage Renal Disease Unit/Facility is in substantial or habitual violation of
				  the standards of health, safety or patient/client care established under State
				  of Federal regulations to the detriment of the welfare of the
				  patient/client.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 126 - REGULATIONS GOVERNING THE LICENSING AND FUNCTIONING OF END STAGE RENAL DISEASE UNITS/FACILITIES › Chapter 3 - LOSS OF, RENEWAL, AND CONDITIONAL LICENSES › Section 144-126-3.F - Appeals

Current through 2024-29, July 17, 2024
Any person aggrieved by the Department's decision to take
					 any of the following actions may request an administrative hearing as provided
					 by the Maine Administrative Procedure Act, Title
					  5 M.R.S.A., §9051,
et seq
.:
3.F.1. Issue
				  a conditional license;
3.F.2. Amend
				  or modify a license; or
3.F.3.
				  Refuse to issue or renew a full license.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 126 - REGULATIONS GOVERNING THE LICENSING AND FUNCTIONING OF END STAGE RENAL DISEASE UNITS/FACILITIES › Chapter 3 - LOSS OF, RENEWAL, AND CONDITIONAL LICENSES › Section 144-126-3.G - Public Notice

Current through 2024-29, July 17, 2024
If a license is revoked, suspended or not renewed, the
					 Department will advise the public of such action. This public notice will be in
					 the form of a paid legal notice in the local newspaper(s), published within
					 fifteen (15) days following the suspension or revocation of the
					 license.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 126 - REGULATIONS GOVERNING THE LICENSING AND FUNCTIONING OF END STAGE RENAL DISEASE UNITS/FACILITIES › Chapter 4 - ADMINISTRATION › Section 144-126-4.A - Organizational Structure and Lines of Authority

Current through 2024-29, July 17, 2024
4.A.1. All ESRD Facilities will identify, in
				  writing, the services provided, administrative control, and lines of authority
				  for the delegation of responsibility down to the patient/client care level. A
				  policy and procedure manual(s), including patient care protocols, for the
				  organization and operation of the facility shall be established, implemented,
				  and reviewed at least annually. Each review of the manual(s) shall be
				  documented. This written material shall be maintained at the ESRD Facility's
				  office so that Department staff can examine it during licensing survey visits.
				  This material will include:
a. A statement
				  describing the organizational goal(s) of the ESRD Facility, its philosophy and
				  objectives, and the services provided by the facility;
b. An organizational diagram delineating the
				  lines of responsibility and accountability so as to ensure continuity of care
				  down to the patients;
c. Job
				  descriptions of employees. The job descriptions shall include the
				  qualifications necessary for the position, an outline of the scope of duties,
				  competencies, responsibilities and accountability required of employees in that
				  position;
d. A description of the
				  orientation programs provided for employees directly employed by the ESRD
				  Facility;
e. If the organization
				  has an advisory or governing body, a set of bylaws specifying the following
				  will be required:
1. Membership;
2. Authority;
3. Administration's role;
4. Frequency of meetings; and
5. Recorded minutes.
The bylaws shall be adopted and updated as deemed necessary
					 by the advisory or governing body.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 126 - REGULATIONS GOVERNING THE LICENSING AND FUNCTIONING OF END STAGE RENAL DISEASE UNITS/FACILITIES › Chapter 4 - ADMINISTRATION › Section 144-126-4.B - Business Records

Current through 2024-29, July 17, 2024
4.B.1. Business
				  records of the ESRD Facility shall be kept and retained in a manner consistent
				  with all applicable State and Federal laws, ordinances and regulations with
				  proper audit trails available. Business records and contracts will be retained
				  for a minimum of seven (7) years.
4.B.2. Copies of the current licenses of all
				  licensed health professionals employed directly or through a contractual
				  relationship with the ESRD Facility shall be maintained by the ESRD
				  Facility.
4.B.3. The ESRD Facility
				  shall keep a personnel file for each health care professional and
				  paraprofessional employed or contracted, which shall include:
a. An application;
b. Evidence of current
				  qualifications;
c. Periodic
				  evaluation;
d. Educational program
				  for training;
e. Evidence of
				  orientation and inservice training; and
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 126 - REGULATIONS GOVERNING THE LICENSING AND FUNCTIONING OF END STAGE RENAL DISEASE UNITS/FACILITIES › Chapter 4 - ADMINISTRATION › Section 144-126-4.C - Qualifications of Professional/Other Personnel

Current through 2024-29, July 17, 2024
4.C.1. The following health care
				  professionals, employed directly or through a contractual relationship with an
				  ESRD Facility, may provide ESRD services by virtue of possession of a current
				  license to practice their discipline in the State of Maine:
a. Physicians;
b. Registered Professional Nurses;
c. Licensed Practical Nurses;
d. Social Workers; and
e. Dietitians.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 126 - REGULATIONS GOVERNING THE LICENSING AND FUNCTIONING OF END STAGE RENAL DISEASE UNITS/FACILITIES › Chapter 4 - ADMINISTRATION › Section 144-126-4.D - Quality Improvement

Current through 2024-29, July 17, 2024
The ESRD Facility shall establish a Quality Improvement
					 Program. The program will be an ongoing objective assessment of important
					 aspects of patient care and the correction of identified problems. It will
					 consist of a clinical record review at least quarterly, and an overall ESRD
					 Facility review that will occur annually. The results of the review/evaluation
					 are reported to, and acted upon by those responsible for the operation of the
					 ESRD.
Components of the Quality Improvement Program will include,
					 but are not limited to:
a. Continual
				  monitoring and evaluation of the care provided;
b. An identification of issues and potential
				  issues;
c. An implementation of
				  improvement activities; and
d.
				  Re-evaluate to determine if further improvement is possible or
				  needed.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 126 - REGULATIONS GOVERNING THE LICENSING AND FUNCTIONING OF END STAGE RENAL DISEASE UNITS/FACILITIES › Chapter 4 - ADMINISTRATION › Section 144-126-4.E - Reporting of Abuse, Neglect or Misappropriation of Client and/or Client's Property

Current through 2024-29, July 17, 2024
a. The ESRD
				  Facility must ensure that all staff are knowledgeable of the Adult Protective
				  Services Act, 22 M.R.S.A., §3477 - 3479A, and that all alleged violations
				  involving mistreatment, neglect and abuse, including injuries of unknown
				  source, and/or misappropriation of client property, are reported immediately,
				  through established procedures, to the administrator of the ESRD Facility and
				  to the officials in accordance with the State law.
b. A procedure must be established by the
				  ESRD Facility for review, within twenty-four (24) hours of each complaint
				  received by the administrator and/or any designated member of the ESRD staff. A
				  report of findings and action taken shall be prepared and submitted to the
				  Quality Assurance Committee or other appropriate committee, and be available
				  for review upon request by the Department.
c. The ESRD Facility must have evidence that
				  all alleged employee violations are thoroughly investigated in a timely manner.
				  Policies must address administrative procedures to be implemented to prevent
				  further potential violations while the investigation is in progress.
d. The results of all investigations
				  conducted in-house must be reported to the administrator or his/her designated
				  representative, and to other officials in accordance with State law. If the
				  alleged violation is verified, appropriate corrective action must be taken. All
				  reports must be made available to the Department upon request.