S.C. Code Regs. § § 61-102.D

Current through Register Vol. 48, 12, December 27, 2024

Section 61-102.D - Professional Care

(1) Limitation of Services Offered by Birthing Center: (I)

In order to be delivered in a birthing center, the woman and/or her infant shall exhibit no evidence of:

(a) severe anemia;

(b) diabetes mellitus;

(c) symptomatic heart disease;

(d) severe hypertension or preeclampsia;

(e) renal disease;

(f) thrombophlebitis;

(g) multiple gestation;

(h) active herpes (within one week of delivery), syphilis, or HIV positive;

(i) placental abnormalities;

(j) premature labor;

(k) intrauterine growth retardation;

(l) fetal disease;

(m) previous caesarean delivery with classical incision;

(n) desire for transfer;

(o) anticipated macrosomia;

(p) breech birth;

(q) six or more (nonmiscarriage or nonabortion) pregnancies;

(r) polyhydramnios or oligohydramnios, or chorionitis;

(s) malformed fetus;

(t) any other high risk condition.

(2) Birthing Center Policies and Procedures: The facility shall formulate written policies and procedures which shall include, but not be limited to: (II)

(a) Informed consent which shall be obtained prior to the onset of labor and shall include evidence of an explanation by personnel of the birthing service offered and potential risks. Documentation of the informed consent must be filed in the patient's chart.

(b) Registration of birth and fetal death or death certificates.

(c) Infection control committee duties and responsibilities shall include the development and implementation of specific patient care and administrative policies aimed at investigating, controlling and preventing infections in the facility.

(d) Arrangements shall be made for all mothers to be screened for blood type and Rh factor. Those determined to be Rh negative shall have provision for appropriate follow-up studies both prenatally and at time of delivery in order to determine the need for Anti D Immune Globulin (Human) to prevent sensitization by the post partum mother. There shall be evidence of a plan for the appropriate use of Rh immune globulin.

(e) The physician or midwife shall, upon the birth of a child, instill or cause to be instilled in each eye of such newborn antibiotics of currently proven efficacy in preventing development of ophthalmia neonatorum. A maximum delay of one hour shall be allowed between the time of birth and the administration of an approved prophylactic agent.

(3) Pharmaceutical Services: (I)

(a) Written policies shall be established addressing the type and intended use of any drug to be used within the facility.

(b) There shall be policies and procedures addressing the receiving, transcribing, and implementing of orders for administration of drugs.

(c) There shall be written prescriptions or orders signed by a practitioner legally authorized to prescribe in South Carolina for all drugs administered to mother and infant within the birthing center.

(d) Drugs shall be administered by personnel or clinical staff currently licensed in South Carolina to administer drugs.

(e) Drugs, medications, and chemicals kept anywhere in the center shall be clearly labeled with drug name, strength, and expiration date.

(f) Drugs, medications, and chemicals shall be stored and secured in specifically designated cabinets, closets, drawers, or storerooms and made accessible only to authorized persons.

(g) Drugs requiring refrigeration shall be kept secure in a refrigerator under proper temperature. Each refrigerator shall be provided with a thermometer.

(4) Laboratory Services:

The center shall enter into a signed written agreement with a certified clinical laboratory to ensure accessibility to a full range of clinical laboratory testing, as may be required.

(5) Birthing Center Equipment and Supplies:

There shall be appropriate equipment and supplies maintained for the mother and the newborn to include but not limited to: (II)

(a) A bed suitable for labor, birth, and recovery;

(b) Oxygen with flow meters and masks or equivalent;

(c) Mechanical suction and bulb suction (immediately available);

(d) Resuscitation equipment to include resuscitation bags, endotracheal tubes and oral airways for the mother and newborn;

(e) Firm surfaces suitable for resuscitation;

(f) Emergency medications, intravenous fluids, and related supplies and equipment for both mother and newborn;

(g) Fetal monitoring equipment;

(h) A means of monitoring and maintaining the optimum body temperature of the newborn;

(i) A clock with a sweep second hand;

(j) Sterile suturing equipment and supplies;

(k) Adjustable examination light;

(l) Containers for soiled linen and waste materials which shall be closed;

(m) Refrigeration unit or units;

(n) Matching identification for the baby to the mother shall be provided.

(6) Clinical Staff:

(a) All clinical staff who practice in a facility shall be organized as a clinical staff with appropriate bylaws approved by the governing body. The clinical staff shall meet at least quarterly and minutes shall be maintained of such meetings.

(1) A physician must be on call and available to provide medical assistance at the birthing center at all times that it is serving the public. (I)

(2) A physician shall make a written determination that the planned birth is low risk. (I)

(3) The center shall enter into a signed written agreement with an obstetrician(s) and a pediatrician(s) to ensure their availability to the staff and mother at all times that it is serving the public. (I)

(b) The facility shall have an organized midwifery department under the supervision of a Director of Midwifery. (II)

(1) The Director of Midwifery shall be a certified nurse-midwife and be responsible and accountable for all midwifery service to include:

(a) delivery of midwifery services to patients;

(b) development and maintenance of midwifery service objectives, standards of midwifery practice, midwifery policy and procedure manuals (reviewed annually), written job descriptions for each type of midwifery personnel;

(c) coordination of midwifery services with other patient services;

(d) establishment of a means of assessing the midwifery care needs of patients and staffing to meet those needs;

(e) staff development.

(c) An adequate number of licensed and ancillary midwifery personnel shall be on duty to meet the total midwifery needs of patients. Midwifery personnel shall be assigned to duties consistent with their training and experience. (I)

(d) At least one member of the clinical staff or a registered nurse shall be in the facility when a patient is present; and up to at least one hour after each mother's delivery. Two members of the clinical staff or one member of the clinical staff and a registered nurse shall be present during the mother's delivery. (I)

(7) Medical Records: An accurate complete medical record shall be maintained for each patient.

(a) A legible medical record in ink shall include at least the following:

(1) admitting identification data including patient history and physical examination;

(2) signed consent;

(3) orders of physician or certified practitioner;

(4) laboratory tests;

(5) prenatal care record containing at least prenatal blood serology, Rh factor determination and obstetrical history and physical examination;

(6) labor and delivery record;

(7) records of anesthesia and analgesia and medication given in the course of labor, delivery and post partum;

(8) recovery and other progress notes;

(9) record of all medications and treatments ordered and administered;

(10) condition and referral on discharge.

(b) Records of newborn infants shall include in addition to the requirements for medical records the following information:

(1) date and hour of birth, birth weight and length, period of gestation, sex, condition of infant on delivery and APGAR rating;

(2) mother's name and patient number, and/or similar identification;

(3) record of opthalmic prophylaxis;

(4) record of administration of Rh immune globulin if any;

(5) appropriate physical examination at birth and at discharge;

(6) Test results and date specimen was collected for PKU and hypothyroid newborn screening test. (Exempt only when parents object because of religious convictions; then file copy of executed "Statement of Religious Objection Form," DHEC #1804 with newborn record.)

(c) Provisions shall be made by the facility for the storage of medical records in an environment which will prevent unauthorized access and deterioration. The records shall be treated as confidential and shall not be disposed of under 10 years. Records may be destroyed after 10 years provided that:

(1) Records of minors must be retained until after the expiration of the period of election following achievement of majority as prescribed by statute.

(2) The facility retains an index, register, or summary cards providing such basic information as dates of admission and discharge, name of responsible clinical staff, and record of diagnoses for all records so destroyed.

(d) Facilities that microfilm before 10 years have expired must film the entire record.

(e) In the event of change of ownership, all medical records shall be transferred to the new owners.

(f) Prior to the closing of a facility for any reason, the facility shall arrange for preservation of records to insure compliance with these regulations. The facility shall notify the Department, in writing, describing these arrangements.

(g) Information to be Provided to Other Health Care Providers. In order to contribute to the continuity of quality of care, procedures must be established and implemented to provide discharge summaries and/or other appropriate information to health care providers to whom patients are discharged, transferred or referred.

S.C. Code Regs. § 61-102.D