Cal. HSC § 1256.06 — California Code / Code hsc / Division 2 / Chapter 2 / Article 1 / Section 1256.06
Section 1256.06
Status: in_force

A hospital requesting approval to establish a standby perinatal service pursuant to Section 1256.05 shall implement and maintain all of the following requirements:

(a) (1) Comply with the most recent standards and recommendations for Level I (Basic Care) of the Levels of Maternal Care and Level 1 (Well Newborn Nursery) of the Neonatal Levels of Care, within the Guidelines for Perinatal Care developed by the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists.

(2) Have the capacity for operative delivery, including caesarean section, and neonatal resuscitation and stabilization at all times.

(3) Have the ability, equipment, and supplies necessary to provide care for mothers and infants needing emergency or immediate life support measures to sustain life up to 12 hours or to prevent major disability, including, but not limited to, all of the following services:

(A) Administration of intravenous or intramuscular antibiotics.

(B) Administration of intravenous or intramuscular uterotonic drugs, including oxytocin.

(C) Administration of intravenous or intramuscular anticonvulsants.

(D) Administration of antihypertensives.

(E) Manual removal of the placenta.

(F) Removal of retained products of conception.

(G) Basic neonatal resuscitation.

(H) Surgery, including caesarean sections.

(I) Blood transfusions.

(J) Additional services specified by the department, in consultation with relevant stakeholders.

(4) Have capabilities for risk identification and determination of conditions necessitating consultation, referral, and transfer.

(5) Have capabilities, including necessary equipment, for stabilization and the ability to facilitate transfer or transport to a higher level of care at all times.

(6) (A) Have the equipment and supplies specified in Section 70551 of Title 22 of the California Code of Regulations, or its successor.

(B) In addition to the items required under subparagraph (A), have all of the following equipment and supplies:

(i) A fetal heart rate monitor that includes both the ability to monitor multiple gestation pregnancies using internal monitors, including fetal scalp electrodes and intrauterine pressure catheters, and maternal pulse integrated to ensure monitoring of fetal pulse and not maternal pulse.

(ii) Provision for oxygen and suction for the mother and infant, including, but not limited to, specialized supplies needed for neonatal resuscitation and breathing support.

(iii) A ventilatory assistance bag and infant masks of assorted sizes for infants of different gestational ages.

(iv) A postpartum hemorrhage kit, including a uterine tamponade device.

(v) Neonatal resuscitation supplies, including supplies for umbilical access for medications.

(vi) Maternal steroid medications available for initial administration in the case of preterm labor while awaiting transport.

(vii) A refrigerated medication storage unit in the standby perinatal service for uterotonic medications requiring refrigerated storage to be immediately accessible in emergencies.

(viii) A suction device appropriate for neonatal resuscitation.

(b) (1) Define the responsibilities of the medical staff and administration associated with the standby perinatal services. Defined responsibilities shall be consistent with the medical staff bylaws and policies established in consultation with the medical staff.

(2) (A) Ensure that a provider of services subject to this section meets all applicable requirements set forth in both of the following:

(i) The medical staff bylaws.

(ii) Rules, regulations, and policies of that facility.

(B) Nothing in this section shall be construed to require changes to the medical staff bylaws or policies regarding credentialing or privileges.

(c) (1) Ensure that a physician who is certified, or eligible for certification, by the American Board of Obstetrics and Gynecology, the American Board of Pediatrics, or the American Board of Family Medicine, and who is a member of the medical staff of the facility, has overall responsibility for the standby perinatal services.

(2) The physician described in paragraph (1) shall be responsible for the development of, and the hospital shall be responsible for the implementation of, policies and procedures for all of the following:

(A) Policies and procedures specified in paragraphs (1) to (28), inclusive, of subdivision (b) of Section 70547 of Title 22 of the California Code of Regulations that align with the standards specified in paragraph (1) of subdivision (a).

(B) Admission policies for infants transferred from an alternative birth center.

(C) Consultations, including, but not limited to, real-time telemedicine services, between the standby perinatal service and health care personnel from an intensive care newborn nursery and from a perinatal service, qualified and available at all times to provide maternal fetal medicine consultation.

(D) Formal arrangements for consultation or transfer of an infant and a mother to a hospital with the necessary services for medical needs beyond the capability of the standby perinatal services.

(E) Current state newborn screening requirements.

(F) Standby perinatal service activation protocols.

(G) Condition-specific management protocols outlining best practices.

(H) Emergency codes.

(I) Documentation standards for antepartum, intrapartum, postpartum, and newborn care.

(J) Surgery and anesthesia services readily available at all times.

(K) Arrangements for incidents of more than one patient requiring the use of the designated standby perinatal service space.

(L) Care management for mothers, fetuses, and neonates in alignment with the standards specified in this section.

(M) Development by an appropriate committee of the medical staff of standardized obstetric and newborn nursing procedures and standardized order sets for pregnant patients presenting to the emergency department and for the standby perinatal service, and for neonates. The committee shall annually review the standardized order sets and update them as necessary.

(N) Convening of an appropriate obstetric and neonatal or pediatric committee that, at a minimum annually, evaluates the services provided and makes appropriate recommendations to the executive committee of the medical staff and administration.

(d) In consultation with the physician described in subdivision (c) and with other appropriate health care professionals, do all of the following:

(1) Implement and maintain contracts, and transfer agreements as applicable, and develop and implement policies and procedures for any maternal or neonatal care outside the scope of the standby perinatal service, including, but not limited to, all of the following services:

(A) Transfer of mothers and neonates to appropriate higher levels of care, including a reliable, accurate, and comprehensive communication system between hospitals initiating and hospitals receiving a patient transfer from a standby perinatal service, hospital personnel, and transport teams.

(B) A blood bank, if the facility might need additional blood.

(C) Ambulance transport and rescue services.

(2) Develop a system for ensuring coverage to provide care for both the mother and the neonate, on call 24 hours a day for the standby perinatal service, including, but not limited to, both of the following:

(A) Physician and nursing staff coverage onsite within 30 minutes.

(B) A roster of physicians and certified nurse-midwives who have an agreement or contract with the hospital, and their immediate contact information, who are available to provide emergency perinatal services.

(3) Have a registered nurse immediately available within the hospital to provide nursing care, including emergency maternal fetal triage and infant resuscitation.

(4) Develop a roster of specialty physicians who have an agreement or contract with the hospital, and their immediate contact information, who are available for consultation at all times.

(5) Conduct monitoring and checkoff to ensure that equipment stays in the standby perinatal service and does not outdate, including a process for the medical staff to report equipment and supplies that are out of date or that were not replaced prior to expiration.

(6) Ensure continuing education for the medical staff.

(7) Establish, and document compliance with, continuing education and training program requirements for nursing staff in perinatal nursing and infection control, including, but not limited to, all of the following:

(A) Biennial, week-long rotations at a Level II, III, or IV maternal or neonatal care facility.

(B) Participation in simulation-based training to reinforce response to obstetric emergencies.

(C) All other continuing education and training programs that are necessary to ensure the safe provision of care for both mothers and neonates in the standby perinatal service.

(8) (A) Annually verify and document all nursing competencies, including, but not limited to, maternal care, fetal and newborn care, postdelivery care, and emergency condition competencies.

(B) Maintain evidence of continuing education and training programs for the nursing staff in perinatal nursing and infection control, including all of the following:

(i) Documented current registered nurse license.

(ii) Current Basic Life Support (BLS) certification.

(iii) Current Advanced Cardiovascular Life Support (ACLS) certification.

(iv) Electronic fetal monitoring certification.

(v) S.T.A.B.L.E. neonatal education program certification.

(vi) Neonatal resuscitation program certification.

(e) Require a physician, certified nurse-midwife, or registered nurse to attend to patients, within the scope of their licensure, under the effect of anesthesia or regional anesthesia, when in active labor, during delivery, or in the immediate postpartum period.

(f) Initiate and sustain an education program and a quality improvement program that are specific to the standby perinatal services to maximize patient safety, in collaboration with facility partners that provide higher levels of care.

(g) Comply with the existing licensed nurse-to-patient ratios for a combined labor/delivery/postpartum area of perinatal services. This subdivision does not alter or amend the effect of any regulation adopted pursuant to Section 1276.4.

(h) Report the data required by Section 1256.05 quarterly and in the manner and method required by the department.

(i) Maintain compliance with federal Medicare obstetrical services conditions of participation, if applicable.

(j) (1) Notwithstanding any other law or regulation, a hospital participating in the pilot project may, in consultation with the medical staff and any relevant personnel, request program flexibility for the statutory requirements of this section, in order to meet the particular capacities and needs of the hospital and community.

(2) If the department approves the request described in paragraph (1), the department’s approval shall provide for the terms and conditions under which the program flexibility is granted.

(3) To request program flexibility for the statutory requirements of this section, the hospital shall follow existing procedures established by the department for program flexibility requests pursuant to subdivision (b) of Section 1276.