216 R.I. Code R. § 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.
Notes
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