N.Y. Comp. Codes R. & Regs. tit. 10 § 405.21

Current through Register Vol. 46, No. 50, December 11, 2024

Section 405.21 - Perinatal services

(a)Applicability.

This section shall apply to all general hospitals having maternity and newborn services and providing pregnancy-related care for women who are pregnant at any stage, parturient or within six weeks from delivery and for infants 28 days of age or less or, regardless of age, who are less than 2,500 grams (51/2 pounds).

(b)Definitions.

For the purposes of this section:

(1)Perinatal services shall mean those services provided in a particular hospital where, as a regular practice, maternity patients and newborn infants receive care on a continuum ranging from preconception services to care during all stages of pregnancy, parturition, postpartum and neonatal care.

(2)Perinatal regionalization system shall mean the statewide organization of maternal and newborn health care services, designed as set forth in Part 721 of this Title, to ensure that mothers and newborns receive the care they need in a timely, safe and effective manner.

(3)Labor room shall mean a room for parturient patients in labor, distinct from patient bedrooms and from operating or delivery rooms.

(4)Delivery room shall mean a room distinct from patient bedrooms and set apart for the delivery of parturient patients.

(5)Single unit maternity or labor-delivery-recovery-postpartum model shall mean a model for family-centered maternity and newborn care in which labor, delivery, nursery and postpartum care are all provided in a single room and movable equipment is introduced and withdrawn from the room as required to provide services and care to the mother and neonate.

(6)Rooming-in shall mean an arrangement which allows the mother and her newborn infant to be cared for together, so that the mother may have access to her infant during all or a substantial part of the day and night, not limited to feeding times.

(7)Newborns shall mean all infants 28 days of age or less.

(8)Premature infant shall mean an infant whose gestational age at birth calculated from the first day of the last menstrual period, or using another reliable method for patients with an unreliable history, is less than 37 completed weeks or 258 completed days.

(9)Low birth weight infant shall mean an infant weighing less than 2,500 grams (51/2 pounds) at birth.

(10)Normal newborn nursery shall mean a room for housing newborns who do not need intensive care and are not suspected of nor diagnosed as having any communicable condition.

(11)Neonatal intensive care unit (NICU) shall mean a room at Level II, Level III and Regional Perinatal Center perinatal care services for housing newborns, including premature infants and low birth weight infants, who require specialized care and who are not suspected of nor diagnosed as having any communicable condition.

(12)Observation nursery shall mean a room, physically separate from the normal newborn nursery, where newborns exposed to potential sources of infection and newborns suspected of but not diagnosed as having any communicable condition may be observed pending diagnosis.

(13)Isolation nursery shall mean a room, physically separate from other nurseries, for the isolation of newborns diagnosed as having any communicable condition.

(14)Family planning shall mean the planning and spacing of children by medically acceptable methods to achieve pregnancy, or prevent unintended pregnancy.

(15)Level I perinatal care service shall mean a comprehensive maternal and newborn service as defined by section 721.2(a) of this Title.

(16)Level II perinatal care service shall mean a comprehensive maternal and newborn service as defined by section 721.2(b) of this Title.

(17)Level III perinatal care service shall mean a comprehensive maternal and newborn service as defined by section 721.2(c) of this Title.

(18)Regional perinatal center (RPC) shall mean a hospital or hospitals housing a Level III perinatal care service as defined in section 721.2(d) of this Title.

(19)Perinatal affiliates shall mean Level I, Level II and Level III hospitals which have a current perinatal affiliation agreement as defined in Part 721 of this Title.

(20)Birth center shall mean a place, other than a traditional hospital childbirth unit or birthing room, where births are planned to occur away from the mother's usual residence following a normal uncomplicated pregnancy.

(21)Birthing room shall mean a hospital room designed as a homelike setting which serves as a combined labor/delivery/recovery room and where family members or other supporting persons may remain with a woman as much as possible throughout the childbirth process.

(22)Quality improvement shall mean improvement of the quality of care provided by the RPC or affiliate hospitals through initiatives and analyses designed to identify and then address potential problem areas in care in its own hospital or in affiliated hospitals, or in the region as a whole, through review of either sentinel cases or patterns of care.

(c)General requirements.

(1) Hospitals providing perinatal services shall provide such services in accordance with current standards of professional practice. Written policies and procedures shall be developed and implemented which address the following:

(i) the professional qualifications of the hospital's obstetric and pediatric staff;

(ii) the requirements for consultation with a qualified specialist when required by specific medical conditions;

(iii) the establishment and implementation of rooming-in at the option of each patient unless the establishment or implementation of such program for that patient is medically contraindicated or unless the hospital does not have sufficient facilities to accommodate all such requests;

(iv) protocols and resources available to stabilize and assess newborns for their need of neonatal intensive care; and

(v) the daily care of maternity patients and infants in the perinatal service.

(2) Medical record for each maternity patient. The medical record for each maternity patient admitted to the perinatal service shall be maintained in accordance with section 405.10 of this Part and also shall include the following:

(i) a copy or abstract of the prenatal record, if existing, including a maternal history and physical examination as well as results of maternal and fetal risk assessment, results of maternal HIV, Hepatitis B and Group B strep testing if done, and ongoing assessments of fetal growth and development and maternal health;

(ii) the results of a current physical examination performed by staff granted privileges to perform such examination that meets the requirements of section 405.9(b)(11) of this Part; and

(iii) labor and birth information including records of fetal monitoring and postpartum assessment.

(3) Medical record for each newborn. The medical record for each newborn shall be cross-referenced with the mother's medical record and contain the following additional information:

(i) newborn physical assessment, including APGAR scores, presence or absence of three cord vessels, ability to feed, vital signs and accommodation to extrauterine life;

(ii) newborn care, including the administration of eye prophylasis and vitamin K;

(iii) description of maternal-newborn interaction; and

(iv) orders for newborn screening tests, including arrangements for screening for hearing.

(4) The hospital shall ensure the transfer to the newborn's medical records of a mother's HIV test result, if one exists.

(5) The hospital shall maintain in a timely manner in the perinatal service area, a register of births, in which shall be recorded the name of each patient admitted, date of admission, date and time of birth, type of delivery, names of personnel present in the delivery room, sex, weight and gestational age of infant, location of delivery and outcome of delivery. Any delivery for which the institution is responsible for filing a birth certificate shall be listed in this register.

(6) Control of infection or other communicable condition. The provisions of section 405.11 of this Part shall apply to the perinatal service. In addition, the following requirements relating to the control of infection or other communicable conditions in the perinatal service shall be met:

(i) each patient admitted to the labor-delivery unit shall be screened for signs of, or exposure to, infection. Those with suspected or confirmed communicable conditions shall be reported to the responsible attending practitioner and the infection control officer for observation or isolation as required;

(ii) isolation precautions shall be carried out for patients in labor with confirmed or suspected infection. There shall be at least one room readily available for the use of a maternity patient requiring isolation. The hospital shall implement safe and effective isolation precautions to prevent the spread of infection and assign professional and other staff in the perinatal service in a manner that will prevent the spread of infection. Written policies and procedures shall be developed and implemented reflecting such isolation precautions;

(iii) the hospital shall adopt and implement written policies and procedures governing the placement in observation or isolation nurseries of infants exposed to or showing signs of developing an infection or communicable condition. Such policies shall not unnecessarily restrict the mother's access to her infant; and

(iv) infection control measures shall be instituted to protect infants when the care and treatment of infants requires common surfaces.

(7) Preconception services. The hospital shall develop and implement written policies and procedures for preconception services either onsite or through referral arrangements. Services shall include but not be limited to family planning, nutritional assessment and counseling, genetic screening and counseling, and identification and treatment of medical conditions that could adversely affect a future pregnancy.

(8) Hospital prenatal care activities.

(i) The hospital shall participate in and shall provide or arrange for effective prenatal care activities including conducting effective community outreach programs either directly or in collaboration with community-based providers and practitioners who provide prenatal care and services to women in the hospital service area. Activities and services of a prenatal care program shall include but not be limited to the following:

(a) active promotion of prenatal care for pregnant women during the first trimester of pregnancy and making services available to patients seeking initial care during each trimester;

(b) the initial prenatal care visit shall include a complete history, physical examination, pelvic examination, laboratory screening, initiation of patient education, screening for nutritional status, nutrition counseling and use of a standardized prenatal risk assessment tool;

(c) arrangements for repeat visits for follow-up prenatal care and education;

(d) nutrition counseling;

(e) psychosocial support services as needed;

(f) ongoing maternal and fetal risk assessment;

(g) prebooking for delivery; and

(h) providing HIV counseling and a clinical recommendation for testing to pregnant women. Counseling and/or testing, if accepted, shall be provided pursuant to Public Health Law, article 27-F. Information regarding the woman's HIV counseling and HIV status must be transferred as part of her medical history to the labor and delivery site. Women with positive test results shall be referred to the necessary health and social services within a clinically appropriate time.

(ii) To perform the activities and provide the services in subparagraph (i) of this paragraph, the perinatal service shall accommodate and coordinate services with primary care providers as follows:

(a) the hospital shall develop a memorandum of understanding with each diagnostic and treatment center, prenatal care provider who is not a member of the medical staff and prenatal care assistance program in the hospital service area. These memoranda shall establish protocols for the provision of prenatal care, testing, prebooking arrangements, timely transfer of records and other necessary services; and

(b) the hospital shall require as a condition of continuing medical staff membership that medical staff members provide to maternity patients under their care prenatal care, prebooking arrangements, testing, timely transfer of records and other necessary services. Written policies and procedures implementing this requirement shall be developed.

(iii) Hospitals shall assure the availability of prenatal childbirth education classes for all prebooked women which address as a minimum the anatomy and physiology of pregnancy, labor and delivery, infant care and feeding, breastfeeding, parenting, nutrition, the effects of smoking, alcohol and other drugs on the fetus, what to expect if transferred, and the newborn screening program with the distribution of newborn screening educational literature.

(iv) The hospital shall assure that each prebooked woman receives the hospital's maternity information leaflet as described in PHL section 2803-j, which includes a written description of available options for labor, delivery and postpartum services. The attending practitioner shall:

(a) advise the woman of options for treatment, care and technological support that are expected to be available at the time of labor and delivery together with the advantages and disadvantages of each option;

(b) answer fully any questions the woman may have regarding the options available; and

(c) obtain from the woman her informed choice of mode of treatment, care and technological support that are expected to be necessary.

(9) Hospitals in consultation with the medical staff shall develop memoranda of understanding with free-standing birth centers in their service area, upon request from such centers, for the prompt admission of women and newborns and transfer of records of any birth center patient whose assessed condition necessitates admission to the level of perinatal service provided by such hospital.

(i) Such transfer shall be accomplished in accordance with the provisions of sections 754.2(e), 754.4, 795.2 and 795.4 of this Title.

(ii) Unless already performed at a free-standing birth center, newborns transferred to a hospital shall have newborn screening performed at the hospital in accordance with Part 69 of this Title.

(iii) The hospital, as part of its quality improvement activities, shall review all maternal and/or newborn transfers from birth centers to ensure adequacy of risk assessment and care, that each transfer has been appropriately arranged, and that reasons for the transfer have been documented clearly.

(10) Quality improvement activities. In addition to the quality assurance provisions of section 405.6 of this Part, the hospital shall, in conjunction with the medical staff and the nursing staff, monitor the quality and appropriateness of patient care and ensure that identified problems are reported to the quality assurance committee together with recommendations for corrective action. In accordance with section 721.9 of this Title, the hospital shall also perform quality improvement activities in accordance with its perinatal affiliation agreement.

(11) Functioning of perinatal services.

(i) Inpatient perinatal services shall be operated as closed units with limited access to unnecessary hospital traffic.

(ii) The perinatal service shall have available: services for the identification of high-risk mothers and fetuses, continuous electronic fetal monitoring, Cesarean delivery capabilities within 30 minutes of determination of need for such procedure, anesthesia services available on a 24-hour basis, radiology and ultrasound examination, with at least one ultrasound machine immediately available for use by the labor and delivery service.

(12) Laboratory services. The perinatal service shall have immediate access to the hospital's laboratory services including a 24-hour capability to provide blood group, Rh type and cross-matching, and basic emergency laboratory evaluations. Either ABO Rh-specific or O-Rh-negative blood and fresh frozen plasma shall be available at the facility at all times. Such other procedures as may be required by the perinatal service shall be performed on a timely basis.

(13) Admissions.

(i) Women in need of medical care and services pertaining to pregnancy, delivery and the puerperal period shall be admitted to the maternity service. Such admission shall be consistent with section 405.9 of this Part.

(a) Each patient shall be attended by a licensed and currently registered obstetrician, family practitioner or licensed midwife who will be responsible for the patient's care.

(b) A patient may not be sent home without the prior knowledge and approval of her attending physician or licensed midwife.

(ii) Admission of nonobstetric patients.

(a) The hospital shall develop and implement written policies and procedures for the admission of nonobstetric female patients to the perinatal service area. The hospital shall ensure that obstetric patients take precedence over nonobstetric patients and that the safety and physical and psychological well-being of obstetric patients are not jeopardized.

(b) The following nonobstetric patients shall not be admitted to the maternity service:

(1) patients undergoing radiation therapy while they retain radioactive materials that have been administered for, or that result from, such treatment; and

(2) patients in an acute, infectious state or with signs and symptoms which may denote infection.

(c) If an acute or chronic infection or any other condition which would have contraindicated admission to the perinatal service is found during surgery or during any other period of hospitalization, the patient shall be removed from the perinatal service area.

(14) Voluntary acknowledgement of paternity for a child born out of wedlock.

(i) If a child is born to an unmarried woman and the putative father is readily identifiable to the responsible hospital staff and available, the hospital shall:

(a) provide to the child's mother and putative father documents and oral and written instructions and information necessary for such mother and father to complete an acknowledgement of paternity form in compliance with section 4135-b of the Public Health Law and section 111-k of the Social Services Law; and

(b) file the executed acknowledgement of paternity with the registrar at the same time at which the certificate of live birth is filed, if possible.

(ii) The hospital shall not be required to seek out or otherwise locate a putative father who is not readily identifiable or available.

(15) Hospitals with a perinatal care service shall participate in the perinatal regionalization system in accordance with their level of care designations under Part 721 of this Title.

(16) Each hospital providing Level I, II or III perinatal care services shall enter into a perinatal affiliation agreement with its designated RPC in accordance with Part 721 of this Title. Level I and II hospitals may also enter into transfer agreements in accordance with Part 721 with Level III hospitals.

(d)High-risk antepartum services at Level II, Level III and RPC perinatal services.

(1) Level II, Level III and/or RPC perinatal services shall develop and implement written policies and procedures to indicate where pregnant patients with obstetric, medical, or surgical complications are to be assigned to provide for their continuous observation and care.

(2) Maternal intensive care services.

(i) Hospitals providing Level I or II perinatal care services shall develop, enter into and implement written agreements with hospitals providing Level III and RPC perinatal care services for the transfer of obstetric patients whose physical conditions are evaluated as needing such higher level of care.

(ii) Hospitals which provide multiple levels of perinatal care services shall develop and implement written protocols and procedures for the in-house transfer of patients who are evaluated as requiring a level of care other than the level being provided in the area where the patient is currently located.

(iii) Evaluation of the patient's condition and need care for intensive care services shall be conducted in accordance with standardized risk assessment criteria based on generally accepted standards of practice which shall be adopted in writing and implemented uniformly throughout the perinatal service.

(iv) Level II, Level III and RPC perinatal care services shall maintain a nursing staff in accordance with the annual clinical staffing plan established under paragraph (8) of subdivision (a) of section 405.5 of this Title that is appropriately trained and adequate in size to provide specialized care to distressed patients. The number of patient care staff on duty during any shift shall reflect the volume and acuity of patient services being provided during that shift.

(v) An RPC shall:

(a) offer education and training to its perinatal affiliates and associated birth centers. Education and training shall be designed to update and enhance staff knowledge and familiarity with relevant procedures and technological advances;

(b) review, in conjunction with its perinatal affiliates, all cases of patients transferred to a higher level of care to determine whether such transfers were appropriate and accomplished according to established transfer agreements; and

(c) participate in case conferences with its perinatal affiliates and associated birth centers to determine whether any non-transferred high-risk cases were handled appropriately and whether the transfer guidelines were adequate to address such circumstances;

(d) for purposes of participation in such activities, the RPC representative or representatives shall be deemed member(s) of the perinatal affiliate's quality assurance committee. RPC representatives may only access confidential patient information for quality improvement purposes through their roles on the affiliate hospitals' quality assurance committees as set forth in the affiliation agreements and these regulations. Members of hospitals' quality assurance committees must maintain the confidentiality of patient information and are subject to the confidentiality restrictions of Public Health Law section 2805-m.

(e)Intrapartum services.

(1) The hospital shall develop and implement written policies and procedures that indicate the areas of responsibility of both medical and nursing personnel for normal, high-risk, and emergency deliveries. These policies and procedures shall be reviewed yearly and made available to all staff. There also shall be written policies for the care of pregnant patients when all antepartum and postpartum beds are occupied.

(2) Written policies and procedures shall be developed and implemented governing restrictions of entry to the closed labor and delivery unit and the hospital shall ensure that, unless medically contraindicated, the patient may choose to be accompanied during labor and delivery by the father and/or other supportive person(s) who can provide emotional comfort and encouragement. Any such contraindications shall be noted in the medical record.

(3) Evaluation and preparation.

(i) In conjunction with the required updated history and physical exam, the hospital shall provide for the following:

(a) laboratory data including serologic tests for blood group, Rh type, syphillis and rubella titer;

(1) if the woman's serology is positive, a cord blood serology shall be obtained. If the sample could not be taken prior to the pregnancy's end, the serology shall be taken at the time of termination of the pregnancy;

(2) the woman shall be evaluated for the risk of sensitization to Rho (D) antigen and if the use of Rh immune globulin is indicated, an appropriate dosage thereof shall be administered to her as soon as possible within 72 hours after delivery or termination of pregnancy;

(b) an assessment of the woman's HIV status and the provision of testing in accordance with section 69-1.3(l) of this Title;

(c) an admitting physical examination which shall include the woman's blood pressure, pulse and temperature, the fetal heart rate, the frequency, duration and evaluation of the quality of the uterine contractions and which shall be recorded in the patient's medical record. An evaluation of any complications should be made. If there is suspected leakage of amniotic fluid or any unusual bleeding, the attending physician or licensed midwife shall be notified immediately before a pelvic examination is performed. When there are no complications or contraindications, qualified nursing personnel may perform the initial pelvic examination to evaluate labor status and the imminence of delivery. The physician or licensed midwife responsible for the woman's care shall be informed of her status, so that a decision can be made regarding further management; and

(d) interval assessments including physical and psychological status of the woman and fetal status.

(ii) Pharmacological or surgical induction or augmentation of labor.

(a)Qualified practitioner as referred to in this section shall mean a practitioner functioning within his or her scope of practice according to State Education Law who meets the hospital's criteria for privileging and credentialing practitioners in management of labor and delivery in accordance with the hospital's policies and procedures.

(b) Pharmacological or surgical induction or augmentation of labor may be initiated only after a qualified practitioner has evaluated the woman, determined that induction or augmentation is medically necessary for the woman or fetus, recorded the indication, obtained informed consent for induction or augmentation of labor, and established a prospective plan of management acceptable to the woman. If the qualified practitioner initiating these procedures does not have privileges to perform cesarean deliveries, a physician who has such privileges shall be contacted directly prior to initiation of the induction or augmentation and a determination made that he or she shall be available within 30 minutes of determination of the need to perform a cesarean delivery. If the patient has had a previous cesarean delivery, a physician with cesarean privileges must be immediately available during pharmacological induction or augmentation of labor.

(c) Pharmacological or surgical induction or augmentation shall be initiated by a qualified practitioner. A qualified practitioner shall initiate the induction or augmentation and shall remain with the woman for a period of time sufficient to ensure that the procedures or medication has been well-tolerated and has caused no adverse reaction. A physician capable of managing any reasonably foreseeable complications from the induction or augmentation of labor shall be available within a timeframe appropriate to the woman's needs.

(d) For pharmacological induction or augmentation of labor, the hospital shall develop and implement a written protocol for the preparation and administration of the oxytocic agent and/or other substances used to induce or augment labor.

(e) During the entire time of the labor induction or augmentation, the woman shall be monitored by staff who are trained and competent in both the monitoring of fetal heart rate and uterine contractions and interpretation of such monitoring. The monitoring shall be by either electronic fetal monitoring or auscultation. Where auscultation is used in lieu of electronic fetal monitoring, it shall be performed no less frequently than every 15 minutes during the first stage of labor and every five minutes during the second stage of labor.

(iii) No attempt shall be made to delay birth of an infant by physical restraint or anesthesia.

(iv) Each maternity patient, when present in a labor, delivery, birthing room or birth center shall be under the care of a registered professional nurse available in accordance with the patient's needs.

(v) The medical record shall be updated to note whenever the woman's choice of position for labor, use of drugs or technological support devices or mode of treatment and care cannot be honored due to medical contraindications. Standing orders for drugs or technological support devices may only be implemented after the nature and consequences of the intervention have been explained to the woman, and the woman agrees to such implementation.

(4) Delivery.

(i) Hospitals shall develop and implement policies and procedures for the delivery room that shall require at least the following:

(a) regular evaluation of maternal blood pressure and pulse both during and after delivery; and

(b) fetal heart evaluation.

(ii) Section 405.13 of this Part concerning anesthesia services shall apply to the clinical perinatal service. The anesthetist shall be informed in advance if complications with the delivery are anticipated.

(iii) The perinatal service and the medical staff shall designate in writing those situations which require consultation with and/or transfer of responsibility from a licensed midwife or a family practice physician to an obstetrician.

(iv) Alternative arrangements for the organization of the perinatal service, including but not limited to birthing rooms, birth centers or single unit maternity models, shall conform to pertinent requirements of this section and Parts 711 and 712 of this Title. Birth centers shall also conform to the patient care provisions of Part 754 of this Title.

(v) Immediate care of the newborn. The practitioner who delivers the baby shall be responsible for the immediate postdelivery care of the newborn until another qualified person assumes this duty. At all times, the newborn shall be attended by a physician or licensed midwife and shall be under the care of a registered professional nurse.

(a) Resuscitation of a distressed newborn. The hospital shall develop and implement policies and procedures for the recognition and immediate resuscitation of a distressed newborn. Level I and II perinatal care services shall accomplish this in consultation with, and with assistance of, the RPC with which the hospital has a perinatal affiliation agreement. The policies and procedures shall include the following elements:

(1) the designation of a physician to assume primary responsibility for the establishment of standards of care, review of practices, maintenance of appropriate drugs and training of personnel;

(2) approval of these policies and procedures by the directors of maternity and newborn services, anesthesia, pediatrics, nursing and by the medical staff;

(3) requirement for immediate availability of needed resuscitative equipment and personnel;

(4) presence in the delivery room of a member of the professional staff specifically qualified in newborn resuscitation;

(5) capability to provide short-term respiratory support including bag and mask ventilation;

(6) procedures for the stabilization of the distressed newborn;

(7) capability to perform endotracheal intubation and umbilical vessel catheterization. For a Level I perinatal care service, the perinatal affiliation agreement with its designated RPC shall provide for staff training to develop current staff competence in these procedures; and

(8) procedures for the preparation and transfer of the distressed newborn to a Level III or RPC perinatal care service when medically indicated.

(b) The hospital shall administer eye prophylaxis and vitamin K in accordance with sections 12.2 and 12.3 of this Title, test for phenylketonuria and other diseases and provide or arrange for newborn hearing in accordance with Part 69 of this Title.

(c) The hospital shall conduct expedited HIV testing of a newborn whose mother's HIV status is unknown at delivery in accordance with section 69-1.3(l) of this Title;

(d) A professional staff person in attendance at a delivery shall ensure proper identification of a newborn before it leaves the room where the delivery has occurred.

(1) The hospital shall ensure continuous identification of the newborn infant during the entire period of hospitalization including verification of identity after each separation and reunion of mother and newborn. In addition to the development and implementation of written policies and procedures for continuous identification, further policies and procedures shall set forth steps to be taken when the means of identification which has been placed on the newborn becomes separated from the newborn.

(2) Newborns born of different mothers shall not be present at the same time in the room where delivery/recovery takes place, unless each has previously been identified by the methods prescribed in this clause.

(e) Circumcision, which shall be an elective procedure, shall not be performed during the newborn stabilization period after birth.

(f)Postpartum care of mother.

Appropriate nursing care shall be available to the mother during the period of recovery after delivery. At all times after delivery, the mother shall have maximum access to her baby unless such access is medically contraindicated and recorded in the appropriate medical record.

(1) The mother shall be transferred to the postpartum area only after her vital signs have stabilized. The hospital shall adopt and implement policies and procedures for identifying any postpartum complications that arise and informing the responsible practitioner who shall manage complications.

(2) Postpartum monitoring shall include the following:

(i) vital signs shall be recorded on a regular basis;

(ii) fluid intake and output shall be recorded. The uterine fundus shall be frequently examined to determine if it is well contracted and whether there is excessive bleeding;

(iii) the patient's practitioner shall be notified of any unusual findings;

(iv) nursing personnel qualified to recognize postpartum emergencies and problems shall be immediately available to the patient;

(v) the father or other support person shall be allowed to remain with the mother during the recovery period unless medically contraindicated or unless the nursing staff determines that the continued presence of the individual would interfere with the continuing care of the mother or other patients;

(vi) a physical assessment of the mother shall be conducted in accordance with established protocols; and

(vii) unless medically contraindicated or unacceptable to the mother, the newborn shall remain with the mother who shall provide a preferred source of body warmth for the newborn. During this period the newborn shall be closely observed for any abnormal signs and breastfeeding shall be encouraged.

(3) Education and orientation of the mother who is planning to raise the baby.

(i) The hospital shall provide instruction and assistance to each maternity patient who has chosen to breastfeed and shall provide information on the advantages of breastfeeding and possible impacts of not breastfeeding to women who are undecided as to the feeding method for their infants. As a minimum:

(a) the hospital shall designate at least one person who is thoroughly trained in breastfeeding physiology and management to be responsible for ensuring the implementation of an effective breastfeeding program. At all times, there should be available at least one staff member qualified to assist and encourage mothers with breastfeeding;

(b) written policies and procedures shall be developed, updated, implemented, and disseminated annually to staff providing maternity or newborn care to assist and encourage the mother to breastfeed which shall include, but not be limited to:

(1) prohibition of the application of standing orders for anti-lactation drugs;

(2) placement of the newborn skin-to-skin for breastfeeding immediately following delivery, unless contraindicated;

(3) restriction of the newborn's supplemental feedings to those indicated by the medical condition of the newborn or of the mother;

(4) provision for the newborn to be fed on demand;

(5) pacifiers or artificial nipples may be supplied by the hospital to breastfeeding infants to decrease pain during procedures, for specific medical reasons, or upon the specific request of the mother. Before providing a pacifier or artificial nipple that has been requested by the mother, the hospital shall educate the mother on the possible impacts to the success of breastfeeding and discuss alternative methods for soothing her infant, and document such education;

(6) prohibition of the distribution of marketing materials, samples or gift packs that include breast milk substitutes, bottles, nipples, pacifiers, or coupons for any such items to pregnant women, mothers or their families;

(7) prohibition of the use of educational materials that refer to proprietary product(s) or bear product logo(s), unless specific to the mother's or infant's needs or condition; and

(8) prohibition of the distribution of any materials that contain messages that promote or advertise infant food or drinks other than breast milk.

(c) the hospital shall provide an education program as soon after admission as possible which shall include but not be limited to:

(1) the importance of scheduling follow-up care with a pediatric care provider within the timeframe following discharge as directed by the discharging pediatric care provider;

(2) the nutritional and physiological aspects of human milk;

(3) the normal process for establishing lactation, including care of the breasts, common problems associated with breastfeeding and frequency of feeding;

(4) the potential impact of early use of pacifiers on the establishment of breastfeeding;

(5) dietary requirements for breastfeeding;

(6) diseases and medication or other substances which may have an effect on breastfeeding;

(7) sanitary procedures to follow in collecting and storing human milk; and

(8) sources for advice and information available to the mother following discharge;

(d) for mothers who have chosen formula feeding or for whom breastfeeding is medically contraindicated, hospitals shall provide individual training in formula preparation and feeding techniques.

(ii) The hospital shall provide to the mother instructions in caring for herself and her baby. Topics to be covered shall include but not be limited: to self-care, nutrition, breast examination, exercise, infant care including taking temperature, feeding, bathing, diapering, infant growth and development and parent-infant relationships.

(iii) The hospital shall determine that the maternity patient can perform basic self-care and infant care techniques prior to discharge or make arrangements for postdischarge instruction.

(iv) Each maternity patient shall be offered a program of instruction and counseling in family planning, if requested by the patient, the hospital shall provide the patient with a list, compiled by the department and made available to the hospital, of providers offering the services requested.

(4) Visiting. The hospital shall develop and implement written policies and procedures regarding visiting that:

(i) do not unreasonably restrict fathers or other primary support person(s) from visitation to the mother during the recovery period;

(ii) promote family bonding by allowing regular visitation for the newborn's siblings in a manner consistent with safety and infection control; and

(iii) permit visitations by other family members and friends in a manner consistent with efficient hospital operation and acceptable standards of care.

(5) Discharge planning. The discharge of mother and newborn shall be performed in accordance with section 405.9 of this Part. In addition, prior to discharge, the hospital shall determine that:

(i) sources of nutrition for the infant and mother will be available and sufficient and if this is not confirmed, the attending practitioner and an appropriate social services agency shall be notified;

(ii) follow-up medical arrangements, consistent with current perinatal guidelines and recommendations, have been made for mother and newborn;

(iii) the mother has been informed of community services, including the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), and shall make referrals to such community services as appropriate;

(iv) the mother has been instructed regarding normal postpartum events, care of breasts and perineum, care of the urinary bladder, amounts of activity allowed, diet, exercise, emotional response, family planning, resumption of coitus and signs of common complications;

(v) the mother has been advised on what to do if any complication or emergency arises;

(vi) the newborn has had a documented and complete physical examination and verification of a passage of stool and urine;

(vii) the means of identification of mother and newborn are matched. If the newborn is discharged in the care of someone other than the mother, the hospital shall ensure that the person or persons are entitled to the custody of the newborn; and

(viii) the newborn is stable; sucking and swallowing abilities are normal. Routine medical evaluation of the neonate's status at two to three days of age shall have been conducted or arranged. Newborn screening shall be conducted at time of discharge, provided discharge is greater than 24 hours after the birth, or between the third and fifth day of life, whichever occurs first, in accordance with Part 69 of this Title.

(g)High-risk neonatal care.

(1) Each hospital providing Level I, II or III perinatal care services shall enter into a perinatal affiliation agreement with its designated RPC in accordance with Part 721 of this Title. Level I and II hospitals may also enter into transfer agreements in accordance with Part 721 of this Title with Level III hospitals.

(i) The perinatal affiliation agreements and transfer agreements shall include provisions for standardized risk assessment based on generally accepted standards of practice, stabilization and resuscitation of newborns as necessary, newborn screening in accordance with Part 69 of this Title, consultation, patient transport, transfer of maternal and newborn records and any other features needed to ensure prompt and efficient transport of newborns that minimize risks and provide the newborn with needed services.

(ii) Unless medically contraindicated, mothers shall be permitted to accompany distressed newborns to receiving perinatal care facilities.

(iii) The perinatal affiliation agreements and transfer agreements shall provide for the return of the distressed newborn to the sending hospital when the condition has been stabilized and return is medically appropriate.

(iv) If transfer necessitates separating the mother and newborn, mothers who have chosen to breastfeed should be encouraged to maintain lactation and breast milk should be available to the newborn.

(2) Placement in nurseries.

(i) Healthy newborns shall be placed in a normal newborn nursery. If a newborn in a normal newborn nursery is removed temporarily from the perinatal service for any reason, the newborn may be returned to the normal newborn nursery only if infection control measures established by the hospital have been followed.

(ii) Newborns requiring specialized care shall be placed in a NICU and hospitals shall develop and implement protocols for all phases of treatment of such newborns. Newborns who are delivered in perinatal care services that are not capable of providing all necessary care and services shall be transferred to perinatal care services at hospitals that can meet the newborns' needs.

(h)Neonatal intensive care services.

(1) Neonatal intensive care services shall be provided by Level II, Level III and RPC perinatal care hospitals.

(2) Decisions regarding the appropriate level of care and the need for transport of a neonate to a higher level of care shall be made consistent with generally accepted standards of care and the hospital's perinatal affiliation agreement.

(3) Treatment of severely ill, injured, or handicapped infants with life-threatening conditions.

(i) Severely ill, injured or handicapped infants exhibiting life-threatening conditions shall be transferred to and/or treated at RPCs or other hospitals having Level III perinatal care services after consultation with that service has established that the infant might benefit from such transfer.

(ii) Level III perinatal care services and RPCs shall consult with the hospital's bioethical review committee which shall assist the service and provide guidance to staff and families in the resolution of issues affecting the care, support and treatment of severely ill, injured, or handicapped infants with life-threatening conditions. The committee:

(a) shall consist of such members of the medical staff, nursing staff, social work staff and administration as designated by the governing body and such other community-based individuals with experience in bioethical matters as may be chosen by the governing body;

(b) shall operate in accordance with written policies and procedures developed by the hospital. Such policies shall establish the protocols for organization and functioning of the committee and scope of responsibility for specified cases as well as development of general review policies governing bioethical matters. The hospital shall:

(1) ensure that the parents are fully advised regarding the infant's condition, prognosis, options for treatment, likely outcomes of such treatment and options, if any, for the discontinuance of heroic life maintenance efforts; and

(2) ensure that any decision by competent parents to continue life-sustaining efforts is implemented by the hospital; and

(c) shall, in conjunction with the attending physician(s), child protective services, the medical staff and the governing body, recommend that the hospital obtain an appropriate court order to undertake a course of treatment, in all cases when in the judgment of the committee:

(1) the parents do not have the capacity to make a decision; or

(2) the parents' decision on a course of action is manifestly against the infant's best interest.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 405.21

Amended New York State Register October 19, 2016/Volume XXXVIII, Issue 42, eff. 1/16/2017

Amended New York State Register November 13, 2019/Volume XLI, Issue 46, eff. 11/13/2019

Amended New York State Register July 19, 2023/Volume XLV, Issue 29, eff. 7/19/2023