216-40-10 R.I. Code R. § 8.5

Current through June 12, 2024

Section 216-RICR-40-10-8.5 - Organization and Management

8.5.1 Governing Body and Management

A. Each Center shall have an organized governing body or equivalent legal authority ultimately responsible for:

1. The management and control of the operation;

2. The assurance of quality care and services;

3. Compliance with all federal, state and local laws and regulations; and

4. Other relevant health and safety requirements, including the rules and regulations of this Part.

B. The governing body or equivalent legal authority shall be responsible to provide a sufficient number of appropriately qualified personnel, physical resources and equipment, supplies and services for the provision of safe, effective and efficient delivery of care services for normal uncomplicated pregnancies to low-risk mothers as defined in this Part.

C. The governing body or equivalent legal authority shall appoint and assure the competence of:

1. An individual responsible for the administrative operation of the Center;

2. A Director of Medical Affairs, responsible for professional practices and services and for the achievement and maintenance of quality care services; and

3. A Director of the Birth Center responsible for the day to day management of the clinical services.

4. The governing body or equivalent legal authority shall furthermore be responsible to establish a mechanism through the organization's by-laws and/or policies to assure that the Director of Medical Affairs, the Director of the Birth Center and other clinical staff are duly qualified by education, training and experience and meet the requirements of this Part.

D. The governing body or equivalent legal authority shall adopt and maintain bylaws defining responsibilities for the operation and performance of the organization, identifying purposes and means of fulfilling such, and in addition the by-laws shall include but not be limited to:

1. A statement of qualifications and responsibilities of the Director of Medical Affairs and the Director of the Center;

2. A statement of the governing body's responsibility for the quality care and services;

3. A statement of policy pertaining to the criteria for the selection, admission and transfer or referral of mothers and/or newborns in accordance with the requirements of this Part;

4. A statement relating to development and implementation of long and short range plans;

5. A statement relating to conflict of interest on the part of the governing body and staff;

6. A policy statement concerning the publication of an annual report, including a certified financial statement; and

7. Such other matters as may be relevant to the organization of the Center.

E. Furthermore, the governing body or equivalent legal authority in consultation with the Director of Medical Affairs shall be ultimately responsible to develop policies governing no less than the following:

1. Modalities of health and medical services to be provided;

2. Involvement of mother and whenever possible, partner, in the development and assessment of plan of care;

3. Signed consent for the provision of services;

4. Referrals and written agreements with other health care facilities, community agencies and medical personnel to insure back-up services and continuity of care in accordance with §8.5.5 of this Part;

5. Effective review of professional practices;

6. Quality assurance for care and services; and

7. Such other matters as may be relevant to the organization and operation of the Center, the delivery of services and as may be required under the rules and regulations of this Part.

8.5.2 Director of Medical Affairs

A. The Director of Medical Affairs shall be appointed by and responsible to the governing body or equivalent legal authority, and shall be a board-certified obstetrician/ gynecologist, with full obstetrical privileges in a licensed hospital nearby the Center. The Director of Medical Affairs may also be designated as the Director of the Birth Centers and may also be designated as the individual responsible for the administrative operation of the Center. Furthermore, the Director of Medical Affairs shall be responsible for:

1. Advising and consulting with the staff of the Center on all matters related to medical management of pregnancy, birth, postpartum, newborn and gynecologic health care and infection control;

2. The approval of written policies and procedures and protocols for midwifery care management where appropriate or applicable;

3. The coordination of all professional medical consultants to the Center (i.e., consulting obstetrical physicians, pediatricians, family practice physicians, etc.); and

4. Such other functions as may be deemed appropriate.

5. In addition, it shall be the responsibility of the Director of Medical Affairs to determine if a mother and/or newborn found to have clinically significant risk factors (see §§ 8.10, 8.11, and 8.12 of this Part) should be admitted to the Center, or whether or not the Center should continue to provide care to the mother and/or newborn during the puerperium period.

8.5.3 Birth Center Director

The Birth Center Director, who may also be the designated individual responsible for the administrative operation of the Center, shall be either an obstetrical physician as defined in this Part, or a midwife licensed in Rhode Island.

8.5.4 Personnel

A. Each Center shall be staffed with an appropriate number of professional and ancillary personnel whose education, training and experience is commensurate with assigned duties and responsibilities.

1. There shall be on the premises at all times when a woman is in labor, a staff person who hold a current certificate in cardiopulmonary resuscitation from a recognized program such as the American Heart Association or the American Red Cross.

B. There shall be at least two (2) staff members attending each birth; one of the two must be an obstetrical physician or a midwife, licensed in Rhode Island. The other member may be a midwife, or an obstetrical physician licensed in Rhode Island, or a nurse, nurse practitioner, or physician assistant licensed in Rhode Island, who has training and experience in obstetrical care and resuscitation of the newborn. Furthermore:

1. Whenever one or more women in active labor are on the premises there shall be at least one staff member on the premises in excess of the number of women in labor.

2. Each Center shall establish a mechanism to enable professional staff of the Center to make immediate telephone contact with an obstetrical physician and a pediatrician on a twenty-four (24) hour basis, seven (7) days a week. Mechanical answering services shall not be acceptable.

3. Each Center must ensure all qualified personnel and clinical staff shall be trained in infant and adult resuscitation. Clinical staff or qualified personnel who have demonstrated the ability to perform neonatal resuscitation procedures must be present during each birth.

C. Each Center shall establish a job description for each classification of position, which clearly delineates qualifications, duties, authority and responsibilities inherent in each position.

D. Records shall be maintained on the premises for all personnel which shall contain no less than:

1. Current background information pertaining to qualifications, including evidence of national criminal background checks for Center personnel whose employment involves routine contact with a patient;

2. Evidence of registration, certification or licensure as may be required by law; and

3. Signed contracts for those employees employed on a part-time basis.

4. Each Center shall require all persons, including students, who examine, observe, or treat a patient to wear a photo identification badge which states, in a reasonably legible manner, the first name, licensure/ registration status, if any, and staff position of such person.

E. Upon hire and prior to delivering services, a pre-employment health screening shall be required for each individual who has or may have direct contact with a patient in the birth Center. Such health screening shall be conducted in accordance with the rules and regulations pertaining to Immunization, Testing, and Health Screening for Health Care Workers (Part 20-15-7 of this Title).

8.5.5 Written Agreements

A. Each Center shall enter into signed written agreements to ensure accessibility to supportive services, and such agreement must clearly delineate the mutual responsibilities of the undersigned parties to ensure the provision of services as agreed upon. Such agreements shall be entered into with no less than:

1. A hospital licensed in Rhode Island which is nearby the Center and which has an obstetrical service, in order to provide emergency back-up services to a mother and/or infant in need of emergency obstetrical and/or pediatric hospital services;

2. "Obstetrical physician(s)" as defined in this Part to ensure availability to the staff and mothers at the Center, twenty-four (24) hours a day, seven (7) days a week, in accordance with agency policies and this Part;

3. A board certified pediatrician, with pediatric privileges in a hospital licensed in Rhode Island;

4. An ambulance service licensed in Rhode Island to ensure the immediate transfer of mothers and/or newborns in emergencies, when appropriate;

5. A clinical laboratory licensed in Rhode Island to ensure accessibility to a full range of clinical laboratory testing, as may be required;

6. A radiological service agreement with a provider licensed in Rhode Island to ensure accessibility to a full range of radiological services, as may be required; and

7. Such other, as may be required for the provision of supportive services (see §8.6.9 of this Part) which are not provided directly by the Center.

8.5.6 Rights of Clients

A. Each Center shall observe applicable provisions of R.I. Gen. Laws § 23-17-19.1 with respect to each client.

B. In accordance with R.I. Gen. Laws § 23-17-19.2, each Center shall display in a conspicuous place on the premises, a copy of the "Rights of Patients" as defined in R.I. Gen. Laws § 23-17-19.1.

8.5.7 Disaster Preparedness

A. Each Center shall develop and maintain a written disaster preparedness plan which shall include specific provisions and procedures for the emergency care of mothers and infants in the event of fire, natural disaster or functional failure of equipment.

1. Such a plan shall be developed and coordinated with appropriate state and local agencies and representatives concerned with emergency safety and rescue.

2. A copy of the plan shall be submitted to the Department.

3. Simulated drills testing the effectiveness of the plan shall be conducted at least semi-annually. Written reports and evaluation of all drills shall be maintained by the Center and available for review by the Department.

B. Emergency steps of action shall be clearly outlined and posted in conspicuous locations throughout the Center.

8.5.8 Administrative Records

A. Each Center shall maintain such administrative records as may be deemed necessary by the Department. These records shall include but not be limited to:

1. Monthly statistical summary of numbers of visits, deliveries appropriately classified;

2. An administrative record, log book or appointment book maintained in chronological sequence of admissions, which shall include pertinent information such as mother's name, age, address, parity, expected delivery date, date of each visit, reason for appointment, complications, date of admission, date of discharge or transfer, morbidity and mortality data, and such other data as may be relevant;

3. A record of all transfers to hospitals or other sources, and consultation; and

4. Such other reports or records as may be deemed appropriate.

8.5.9 Uniform Reporting System

A. Each Center shall establish and maintain records and data in such a manner as to make uniform the system of periodic reporting. The manner in which the requirements of this Part may be met shall be prescribed from time to time in directives promulgated by the Director.

B. Each Center shall report to the Department detailed statistical data pertaining to its operation, services and facility. Such reports and data shall be made at such intervals and by such dates as determined by the Director.

C. The Department is authorized to make the reported data available to any state or federal agency concerned with or exercising jurisdiction over the Center.

D. The directives promulgated by the Director pursuant to this Part shall be sent to each Center to which they apply. Such directives shall prescribe the form and manner in which the statistical data required shall be furnished to the Department.

216 R.I. Code R. § 216-RICR-40-10-8.5

Amended effective 11/25/2018