216 R.I. Code R. 216-RICR-40-10-8.6

Current through December 26, 2024

Section 216-RICR-40-10-8.6 - Management of Clinical Services

8.6.1 Selection of Clients

A. Each Center shall clearly delineate in its policy and procedure manual the medical and social risk factors which exclude women from the low-risk intrapartum group. At a minimum, mothers with problems and conditions considered to be high-risk as listed in § 8.10 of this Part, must be precluded from admission to the Center's services, except mothers with problems and conditions identified with an asterisk in § 8.10 of this Part shall require in each particular case for the Director of Medical Affairs to make a determination as to whether or not the mother may be admitted to the Center for services in accordance with §8.5.2 of this Part.

B. Therefore, only those mothers who have no abnormal findings or findings declared insignificant (see §8.6.1(A) of this Part) and demonstrate the potential for an uncomplicated course of pregnancy and labor, may be accepted for childbirth at the Center.

C. An initial assessment shall be made of every woman seeking Birth Center services. Such assessment shall be made by a professional staff member (obstetrician and/or midwife) to determine eligibility of the women for admission to the Center in accordance with the provisions of §8.6.1(A) of this Part. All findings of the assessment shall be recorded into the clinical record, signed by the responsible person and countersigned by the Director of Medical Affairs.

D. Women who fail to register with the Center before the end of first trimester shall be excluded from admission unless a written, signed exception is made by the Director of Medical Affairs on an individual basis.

8.6.2 Orientation and Childbirth Education

A. Each Center shall assure that each woman and family registering for care at the Center shall be given an orientation to the Center which includes information pertaining to no less than:

1. The philosophy and goals of the Center;

2. Services available directly at the Center;

3. Services provided through consultation and referrals;

4. Policies and procedures;

5. Requirement for signed written consent for care and services, attesting to full awareness of care and services to be provided;

6. Involvement of mother (and partner whenever possible) in the development and assessment of plan of care in accordance with §8.6.10 of this Part;

7. Charges for required care and potential additional charges;

8. Risk factors associated with possible poor outcomes which are subject to the Director of Medical Affairs' final determination; and

9. Such other matters as may be deemed appropriate.

B. A childbirth education program shall be provided or made available by each Center. The program shall consist of a course of instruction to expectant mothers pertaining to prenatal care and its outcome, care of the newborn, and to provide an understanding of labor and delivery, self-care and preparation for their participation in the childbirth process.

1. All women who have not previously attended a basic childbirth education program must attend a program of childbirth education and preferably with a support person.

8.6.3 Prenatal Care

A. The Center shall ensure that mothers have adequate prenatal care in accordance with the Center's written policies and procedures and acceptable standards of practice. The policies shall require:

1. Every mother to be enrolled in the development and assessment of plan of care.

2. Every mother to be evaluated within two (2) weeks of the initial request for care in order to establish a data base of risk assessment, identification of problems and needs, and to develop a protocol of car which must include:

a. Data from history, physical examination;

b. Laboratory findings, (results of gestational diabetes test at appropriate time - 26 weeks);

c. Social, nutritional and health assessments; and

d. Frequency of prenatal visits.

3. Every mother accepted for care at the Center shall be evaluated on a regular basis for the presence of any high-risk factor listed in §8.10.2 of this Part. Mothers who develop problems or conditions considered to be high-risk shall require in each particular case that the Director of Medical Affairs makes a determination as to whether or not the Center may continue to provide care to the mother. Findings shall be entered in the clinical record and signed by the Director of Medical Affairs.

8.6.4 High-Risk Factors Requiring Transfer of Mother and/or Newborn

A. Any risk factor pertaining to labor, delivery or postpartum periods as outlined in §§ 8.11 and 8.12 of this Part shall be cause to preclude continuation of care of the mother and/or newborn at the Center with the exception of those risk factors identified with an asterisk which shall be subject to the Director of Medical Affairs' final determination in accordance with §8.5.2 of this Part.

1. If a clinical complication occurs in the course of labor, delivery or postpartum, it is the responsibility of the obstetrical physician or midwife to have the mother and/or newborn transferred promptly to a licensed hospital obstetrical service and notify the Director of Medical Affairs. When indicated, a physician, nurse, nurse practitioner, or physician assistant, or midwife shall accompany the patient.

2. Consultation with the Board Certified OB/GYN and/or Pediatrician as the case may indicate shall be required in doubtful cases to ascertain referral and/or transfer to the hospital obstetrical and/or newborn service and/or other.

3. Appropriate records shall accompany a mother and/or newborn upon transfer.

8.6.5 Postpartum Care

A. In general, mothers and newborns shall be discharged within twenty-four (24) hours after birth in accordance with written policies and procedures established by the Center. If a mother or newborn is not in satisfactory condition for discharge within twenty-four (24) hours following birth, the mother and/or newborn shall be transferred to a hospital licensed in Rhode Island which has an obstetrical and nursery service. (See §8.5.5(A)(1) of this Part).

B. Furthermore, the written policies and procedures established by the Director of Medical Affairs for a follow-up program of care and postpartum evaluation after discharge from the Center shall include no less than:

1. The Center's physician, midwife or nurse must be accessible by telephone, twenty-four (24) hours a day to mothers, to assist mothers in case of need during the postpartum period;

2. A home visit within twenty-four (24) to forty-eight (48) hours of discharge by the Center's professional staff personnel to insure continuity of care, and assessment of mother and newborn; and

3. The Center's postpartum program must include provisions for the assessment of mother and infant, including physical examination, laboratory screening tests at appropriate times, maternal postpartum status, instructions in child care, including immunization, referral to sources of pediatric care, provisions for family planning services, and assessment of mother-child relationship including breast feeding.

8.6.6 Analgesia and Anesthesia

A. Inhalation or intravenous anesthesia shall not be administered at any Birth Center.

B. Local anesthesia for episiotomies and/or repair of lacerations may be performed in accordance with written procedures established by the Director of Medical Affairs.

C. Systemic non-narcotic analgesia may be administered but pain control should depend primarily on emotional support and adequate preparation for the birth experience.

8.6.7 Food Service

A. Each Center shall have the capacity to provide mothers and families with appropriate nourishment and light snacks. The minimum equipment shall include refrigerator, stove, sink, cupboard and counter space or equivalent.

B. Food may be prepared by the family or prepared in the Center. When meals are prepared and served by the Center, the Center will be subject to the Rhode Island Food Code (Part 50-10-1 of this Title).

8.6.8 Laboratory Services

Each Center must have assurance of accessibility to a full range of clinical laboratory tests in accordance with the provisions of written agreements as required in §8.5.5 of this Part.

8.6.9 Other Services

Each Center shall have assurance of access to a full range of diagnostic services including laboratory, sonography, radiology, electronic monitoring, intensive care and emergency transportation in accordance with the requirements of §8.5.5(A) (5) of this Part.

8.6.10 Plan of Care

A. A written plan of care shall be established by professional staff for each mother accepted for care at the Center, including the newborn.

1. After assessment and discussion of the mother's needs, the plan of care shall be developed with the participation of the mother, and partner whenever possible. A plan which is mutually acceptable to staff and mother, shall include those provisions required by law and shall clearly identify parental choices for those care services available at the Center, such as: local anesthesia for episiotomies or for repair of laceration, breast feeding, circumcision of newborn male, need for postpartum supportive services.

2. Furthermore, the mother shall be involved in the continuous assessment and revision as may be required of the plan of care. In addition to the above, the plan of care shall include provisions pertaining to the following:

a. Prenatal Care.

(1) Personal and family history;

(2) Findings of physical examination(s) and laboratory tests; and

(3) Continuous assessment of mother for high-risk factors.

b. Labor.

(1) Documentation of progress in labor and findings of examinations; and

(2) Ensuring that clinical staff or qualified personnel who have demonstrated the ability to perform neonatal resuscitation procedures are present, pursuant to §8.5.4(B)(3) of this Part.

c. Intrapartum and postpartum care.

(1) Immediate postpartum care and newborn assessment;

(2) Eye prophylaxis to newborn;

(3) Test for appropriate use of RH immune globulin, and metabolic screening and other tests for the newborn as may be required by law;

(4) Postpartum examination and family planning and follow-up care;

(5) Preparation and submission of birth certificates; and

(6) Such other care as may be deemed necessary and appropriate.

8.6.11 Clinical Records

A. The Center shall maintain a clinical record for every mother and newborn serviced at the Center. Such record shall contain accurate documentation of significant clinical information pertaining to the mother and newborn sufficiently detailed and organized in such a manner to enable:

1. The responsible practitioners to provide effective continuing care to determine retrospectively the condition of the mother and newborn infant and to review procedures performed and individual's responses to the care;

2. A consultant to render an opinion after examination and review of clinical record;

3. Another practitioner to assume the care of the mother or the newborn at any time;

4. Pertinent information for quality assurance assessments to be retrieved;

5. The clinical staff to utilize the record to instruct mother and family.

B. The clinical records shall contain significant documented data to assist the clinical staff in their determinations of high-risk factors throughout the course of the mother's pregnancy, labor and delivery including the newborn in accordance with the risk-factors identified in §§ 8.10, 8.11, and 8.12 of this Part. Clinical records shall furthermore contain no less than:

1. Admitting identification data, including history, physical examination and risk assessment;

2. Signed consent;

3. Prenatal record containing blood serology, rubella screening and RH factor, blood typing and screening for irregular antibodies;

4. Labor and delivery records;

5. Clinical observations during prenatal care, labor and delivery, postpartum care, including laboratory reports, medical orders, consultation reports, signed entries by professionals rendering care;

6. Newborn record including all pertinent data of assessment and other care;

7. Complications, transfers, referrals;

8. Report of postpartum home visits;

9. Discharge summary; and

10. Such other information, data and reports as may be deemed necessary.

C. All entries in the clinical records shall be signed by the responsible person in accordance with the Center's policies and procedures.

D. All clinical records either original or accurate reproductions shall be preserved for a minimum of five (5) years following discharge of the mother and/or newborn in accordance with R.I. Gen. Laws § 23-3-26.

1. Records of minors shall be kept for at least five (5) years after such minor shall have reached the age of eighteen (18) years.

8.6.12 Infection Control

A. A mechanism shall be established by the Director of Medical Affairs for the development of infection control policies which shall pertain to no less than:

1. Infection surveillance activities;

2. Sanitation and asepsis;

3. Handling and disposal of waste and contaminants;

4. Sterilization, disinfection and laundry;

5. Reporting, recording and evaluation of occurrences of infections; and

6. Documentation of infection rate.

B. The Center shall report promptly to the Department infectious diseases which may present a potential hazard to patients, personnel and the public. Included are reportable diseases and the occurrences of other diseases in outbreak form.

216 R.I. Code R. 216-RICR-40-10-8.6

Amended effective 11/25/2018