Part 795 - Midwifery Birth Centers

Effective Date: 
Wednesday, November 13, 2019
Statutory Authority: 
Public Health Law, Sections 2801 and 2803(11)

Section 795.1 - Definitions

Section 795.1 Definitions. As used in this Part:

(a) A midwifery birth center means a facility licensed pursuant to Article 28 of the Public Health Law that is engaged principally in providing prenatal and obstetric care, and where such services are provided principally by midwives. The facility shall be organized to provide prenatal, child birth and postpartum care and primary preventive reproductive health care to patients at low risk. Services are provided by a midwife, licensed pursuant to Article 140 of the Education Law, to patients at low risk, during pregnancy, labor, delivery, and who require only a stay of less than 24 hours after birth. Such services shall include newborn evaluation, resuscitation and referral. Midwifery birth center services are based on a philosophy that promotes a home-like setting and family-centered approach to care and views pregnancy and delivery as a normal physiological process requiring limited technological and pharmacological support. The center services are designed to meet the specific needs of the population being served and promote optimum pregnancy outcomes. The licensed midwife provides care for the low-risk patient during pregnancy and remains available to the patient during labor from the time of admission to the midwifery birth center through the immediate postpartum period, providing continuous physical and emotional support, evaluating progress, facilitating family interaction and assisting the patient in labor and delivery. Other health care providers can provide prenatal and postpartum care to midwifery birth center patients. They may also provide supportive care during labor and delivery, but the attending provider for birth must be a licensed midwife.

(b) A patient at low risk means a patient who has: a normal medical, surgical, and obstetrical history; a normal, uncomplicated pregnancy as determined by adequate prenatal care; and prospects for a normal, uncomplicated gestation and birth. Risk shall be determined using standardized criteria based on generally accepted standards of professional practice.

(c) The Department means the New York State Department of Health.

Effective Date: 
Wednesday, November 13, 2019
Statutory Authority: 
Public Health Law, Sections 2801 and 2803(11)

Section 795.2 - Administrative requirements

Section 795.2 Administrative requirements. The operator shall ensure that:

(a) only patients at low risk are admitted and cared for at the midwifery birth center;

(b) written policies, procedures and standard risk assessment criteria for determining low-risk pregnancies based upon generally accepted standards of practice are developed and implemented;

(c) written policies, procedures and protocols for the management of care are implemented pursuant to generally accepted standards of practice and in accordance with midwifery birth center philosophy;

(d) a record is made of all informed consent, including shared decision making, that indicates concurrence from both caregiver and patient parties;

(e) there is a transfer agreement with one or more perinatal centers for medical care of patients when complications arise antepartum, intrapartum, or postpartum and that meets the following requirements:

(1) compliance with section 400.9 of this Title;

(2) the surface travel time to reach a receiving perinatal hospital is less than two hours under usual weather and road conditions; and

(3) the receiving hospital is accessible and convenient to the patient’s place of residence whenever possible;       

(f) support services such as laboratory, radiology and imaging, and family planning services not provided by the midwifery birth center are available by referral;

(g) the midwifery birth center services are available 24 hours a day for the admission of patients, professional consultation and prompt response to inquiries;

(h) kitchen facilities are available to enable families to store and prepare food brought in for the laboring family;

(i) the midwifery birth center acts in accordance with the requirements of section 405.21(c)(14) of this Title with respect to a voluntary acknowledgement of paternity for a child born out of wedlock;

(j) the midwifery birth center refers patients for genetic screening, carrier testing, and genetic counseling as needed;

(k) the midwifery birth center refers patients requiring physical or occupational therapy to an appropriate therapist as needed; and

(l) the needs of infants demonstrating difficulty feeding and swallowing are addressed to ensure the infant is healthy and developing properly, including referral to a lactation consultant or licensed speech and language pathologist as needed.

Effective Date: 
Wednesday, November 13, 2019
Statutory Authority: 
Public Health Law, Sections 2801 and 2803(11)

Section 795.3 - Service restrictions

Section 795.3 Service restrictions. The operator shall ensure that:

(a) only patients at low risk are admitted and cared for at the midwifery birth center;

(b) surgical procedures are limited to those which may be performed during and after an uncomplicated childbirth, such as episiotomy and repair. Other surgical procedures, including forceps and vacuum extraction are not permitted;

(c) general and regional anesthesia are not administered at the center; and

(d) labor is not induced, inhibited, stimulated or augmented with pharmacological agents acting directly on the uterus during the first or second stages of labor.

Effective Date: 
Wednesday, November 13, 2019
Statutory Authority: 
Public Health Law, Sections 2801 and 2803(11)

Section 795.4 - Midwifery birth center transfer procedures

Section 795.4 Midwifery birth center transfer procedures.

(a) The midwifery birth center shall maintain the capability to evaluate, stabilize and transfer patients other than patients at low risk, including newborns. The midwifery birth center shall refer or transfer patients for any health care services that fall outside the scope of midwifery birth center resources and risk criteria at any point during the course of care. The midwifery birth center shall initiate transfer when risks are identified, including when there is prolonged labor, fetal distress, or a need for spinal or epidural anesthesia, or when there may be an operative or cesarean birth.

(b) Midwifery birth centers shall have written plans and procedures for the transfer of patients to the obstetrical or pediatric services of the receiving hospital(s) when complications arise. Such plans and procedures shall include arrangements for an ambulance service and, when necessary, accompanying the patient in the ambulance with a clinical staff member of the midwifery birth center.

(c) The operator, in consultation with the receiving hospital(s), shall develop a list of indicators necessitating transfer and a written procedure for automatic acceptance of such transfers by the receiving hospital, which shall include transfer of patients when neonatal abstinence syndrome or fetal alcohol syndrome is evident or suspected.

(d) The operator shall implement a system to ensure that a copy of the medical record accompanies the patient upon transfer to the hospital.

(e) The operator shall establish a mechanism for jointly reviewing all transfer cases by the receiving hospital(s) and the midwifery birth center as part of the quality assurance program specified in section 795.9 of this Part.

Effective Date: 
Wednesday, November 13, 2019
Statutory Authority: 
Public Health Law, Sections 2801 and 2803(11)

Section 795.5 - Midwifery birth center director and medical consultants

Section  795.5 Midwifery birth center director and medical consultants. The operator shall appoint a midwifery birth center director who:

(a) is a licensed midwife or physician;

(b) maintains documentation of collaborative relationships required under Section 6951 of the Education Law;

(c) approves all policies, procedures and protocols for the management of care;

(d) approves standardized criteria for admission screening and monitoring risk status during pregnancy, labor, birth and postpartum;

(e) is available for consultation and referral or has made arrangements with a qualified physician for these services;

(f) may appoint a consultant physician who:

(1) is a qualified specialist, as defined in section 700.2 of this Title, in pediatrics or family practice and who has pediatric privileges that include admission and care of newborns at the receiving hospital(s). In the absence of pediatric privileges, there must be formal arrangements included in the transfer agreement for the provision of pediatric care at the receiving hospital(s); and

(2) is available for consultation and referral;

(g) ensures that the midwifery birth center has:

(1) collaborative relationships with one or more licensed physicians who are board certified as obstetrician-gynecologists by a national certifying body, who practice obstetrics, and who have obstetric privileges at one or more general hospitals licensed under Article 28 of the Public Health Law;

(2) collaborative relationships with pediatricians and other medical specialists needed to meet patients’ needs, including with at least one pediatrician who has pediatric privileges that include admission and care of newborns at the receiving hospital(s). In the absence of pediatric privileges, there shall be arrangements for the provision of pediatric care at the receiving hospital(s); and

(3) transfer agreements with perinatal centers licensed under Article 28 of the Public Health Law to provide:

(i) obstetrics through a licensed physician having obstetrical privileges at such perinatal center;

(ii) consultation, collaborative management and referral to address the health status and risks of the provider’s patients; and

(iii) emergency medical coverage for patients; and

(h) has standardized criteria for admission screening and monitoring risk.

Effective Date: 
Wednesday, November 13, 2019
Statutory Authority: 
Public Health Law, Sections 2801 and 2803(11)

Section 795.6 - Clinical staff

Section  795.6 Clinical staff. The operator shall ensure that:

(a) a licensed midwife attends each patient from the time of admission, during labor, during the birth and through the immediate postpartum period, and that such practitioner maintains current certification by the American Academy of Pediatrics as a Neonatal Resuscitation Program (NRP) provider;

(b) a second trained staff person is also present at each birth who:

(1) is under the supervision of the licensed midwife;

(2) has specialized training in labor and delivery techniques and care of the midwifery birth center patient;

(3) receives planned and ongoing training as needed to perform assigned duties effectively; and

(4) maintains current status as a NRP provider;           

(c) trained and qualified staff are available to educate and assist patients to initiate breastfeeding; and

(d) at least two people who attend patients during labor, delivery and postpartum are currently certified NRP, Basic Life Support (BLS), and Advanced Cardiac Life Support (ACLS) providers and are able to provide oxygen and all equipment necessary to maintain airways for the patient and infant.

Effective Date: 
Wednesday, November 13, 2019
Statutory Authority: 
Public Health Law, Sections 2801 and 2803(11)

Section 795.7 - Services for the care of patients

Section 795.7 Services for the care of patients. All patients shall be assessed to determine availability of sufficient resources prior to and following delivery. The operator shall ensure that the midwifery birth center provides at least the following:

(a) admission screenings to ensure that only patients at low risk are admitted to the midwifery birth center;

(b) active participation by patients and families in their own plan of health care, which shall include but not be limited to:

(1) orientation to the midwifery birth center services and its philosophy and goals preceding registration; and

(2) access to prenatal education classes approved by the clinical staff which address, at a minimum, labor and delivery, infant care and feeding, parenting, nutrition, the effects of smoking, alcohol and other drugs on fetal development and on the newborn patient, signs of postpartum depression, what to expect if transferred, and the newborn screening program, including hearing screening, with the provision and distribution of newborn screening educational literature;

(c) prenatal and intrapartum care including:

(1) a plan of care developed according to accepted professional standards;

(2) selection of pediatric services by the patient for follow-up care of the infant;

(3) providing HIV counseling and recommending voluntary testing to pregnant patients during a prenatal visit. Counseling and/or testing, if accepted, shall be provided pursuant to Public Health Law Article 27-F. Information regarding the patient’s HIV counseling and HIV status must be transferred as part of the patient’s medical history to the labor and delivery site. Patients with positive test results shall be referred to the necessary health and social services within a clinically appropriate time;

(4) continuous risk assessment of all patients;

(5) labor support and professional attendance at birth for the patient and the patient’s family;

(6) consultation with perinatal qualified mental health professionals to determine the appropriate course of action for patients who screen positive during the prenatal screening for depression or perinatal mood disorder or who have other mental health conditions;

(7) a system for screening patients prior to admission for alcohol/substance use during pregnancy and for prior physical, sexual and emotional abuse, as part of routine obstetric care, and for referral of patients as appropriate to a higher-level facility; and

(8) a system for directing patients to appropriate health care providers for further diagnosis and treatment, including consultation by a radiologist or qualified provider who can interpret imaging results when results are inconclusive or an abnormality is detected that requires immediate care;

(d) postpartum care including:

(1) care in the midwifery birth center to be provided for a minimum of four hours and a maximum of 24 hours after the third stage of labor is complete;

(2) a physical assessment of the newborn with the required eye prophylaxis in accordance with sections 12.2 and 12.3 of this Title and newborn screening tests in accordance with Part 69 of this Title;

(3) birth registration in accordance with section 4130 of the Public Health Law;

(4) a physical assessment of the patient in accordance with established protocols including the evaluation of Rh status, need for Rh prophylaxis and the patient’s ability to feed the infant prior to discharge from the center; and

(5) the transfer to the newborn’s medical record of a patient’s HIV test result, if one exists; and

(e) discharge and follow-up including:

(1) a program for discharge and follow-up of the patient and infant in their home for the immediate postpartum period unless arrangements have been made for the infant to be seen by another health care provider. The home visits may be performed by licensed professional nursing staff from the midwifery birth center, if the facility is approved under article 36 of the Public Health Law, or through an agreement with a certified or licensed home health agency, to include an assessment of the parent-child relationship, an evaluation of the nutritional status of the infant and the physical and psychological status of the patient, performance of a hematocrit, rubella vaccination and Rh prophylaxis, if indicated, and newborn screening blood collection in accordance with Part 69 of this Title;

(2) assurance of immediate and ongoing pediatric care;

(3) provision of family planning counseling or arrangements for such services, if desired by the patient; and

(4) arrangements for follow-up visits at the midwifery birth center within a six-week period following the birth.

Effective Date: 
Wednesday, November 13, 2019
Statutory Authority: 
Public Health Law, Sections 2801 and 2803(11)

Section 795.8 - Medical records

Section 795.8 Medical records. The operator shall ensure that, in addition to meeting the requirements in section 751.7 of this Title:

(a) The medical record for each patient shall contain the following information:

(1) results of physical and risk assessments;

(2) patient history, to include medical, surgical, gynecological and psychosocial history;

(3) record of informed consent, including shared decision making, for midwifery birth center services;

(4) ongoing assessments of fetal growth and development;

(5) periodic evaluations of patient health;

(6) results of laboratory tests;

(7) labor and birth information;

(8) newborn patient physical assessment, including APGAR scores, maternal-newborn interaction, ability to feed, eye prophylaxis, vital signs and accommodation to extrauterine life;

(9) postpartum assessment;

(10) discharge and follow-up plans;

(11) home visit reports;

(12) midwifery birth center follow-up visit report; and

(13) documentation of family planning counseling and the arrangements made for family planning services, if any.

(b) The medical record for each newborn shall be cross-referenced with the patient’s medical record and contain the following information:

(1) copy of the newborn physical assessment;

(2) results from newborn screening tests;

(3) discharge summary with follow-up plans; and

(4) home visit report.

 

Effective Date: 
Wednesday, November 13, 2019
Statutory Authority: 
Public Health Law, Sections 2801 and 2803(11)

Section 795.9 - Quality assurance

Section 795.9 Quality assurance. In addition to meeting the requirements set forth in section 795.8 of this Title, the operator shall ensure that there is a review of all pregnant and postpartum patients and/or newborn hospital transfers, with reasons for such transfers documented. Findings from these reviews shall be used by the operator and midwifery birth center director in the development and revision of policies and in the consideration of renewing or granting staff privileges.

 

Effective Date: 
Wednesday, November 13, 2019
Statutory Authority: 
Public Health Law, Sections 2801 and 2803(11)

Section 795.10 - Emergency care

Section 795.10 Emergency care. The midwifery birth center shall have the capability and equipment to provide care to patients at low risk and a readiness at all times to meet any unexpected needs of patients within the center, and to facilitate transport to an acute care setting when necessary. The midwifery birth center shall stabilize and transfer patients to an appropriate general hospital for continued care when medically indicated. Staff with required current course completion status in NRP, BLS, and ACLS shall be available and shall have immediate access to all necessary equipment in accordance with these certifications to initiate resuscitation of patients. The midwifery birth center must have availability of adequate numbers of qualified professionals with competence and ability to stabilize and transfer high-risk patients. The operator shall ensure that at a minimum:

(a) emergency equipment and supplies approved by the midwifery birth center director are available for use for resuscitation of both adult and neonate patients and include at least the following:

(1) intravenous therapy equipment;

(2) infant warmer;

(3) infant transport equipment;

(4) oxygen and oxygen administration equipment for patient and infant;

(5) airways and manual breathing bags for patient and infant;

(6) suction machine and equipment for patient and infant;

(7) adult and infant laryngoscope and endotracheal tubes; and

(8) medications and intravenous fluids with supplies and equipment for administration;

(b) center staff are certified in NRP, BLS, and ACLS resuscitation and other emergency procedures; and

(c) a licensed midwife, and one other staff member, both trained in NRP, BLS, and ACLS emergency procedures, are on duty in the center when patients are in the midwifery birth center.

 

Effective Date: 
Wednesday, November 13, 2019
Statutory Authority: 
Public Health Law, Sections 2801 and 2803(11)

Section 795.11 - Midwifery birth center accreditation

Section 795.11 Midwifery birth center accreditation.

(a) Midwifery birth centers must comply with sections 400.2 through 400.7, 400.9, and 400.10, and sections 751.5 through 751.10 of this Title and must comply with evidence-based standards for midwifery birth centers published by a national standards body selected by the Department and published on the Department’s website. The Department may accept, as evidence of compliance with minimum operational standards in this subdivision, accreditation by an accreditation agency that the Department has determined has accrediting standards sufficient to assure the Department that midwifery birth centers so accredited are in compliance with such minimum operational standards. The Department may enter into collaborative agreements with one or more accreditation agencies to provide that such an agency’s accreditation survey can be used in lieu of a survey by the Department. As part of such collaborative agreements, an accreditation agency may, at the Department’s discretion, investigate complaints received by the Department related to care and services provided by a midwifery birth center. Notwithstanding any such collaborative agreements, the Department reserves the right to survey any midwifery birth center for compliance with the evidence-based standards established pursuant to this section. A list of accreditation agencies with which the Department has a collaborative agreement will be posted on the Department’s website.

(b) Except as otherwise prohibited by law, all survey reports, complaint investigation results, plans of correction, interim self-evaluation reports, certificates of accreditation, notices of noncompliance, or any other document, provided to the Department by an accreditation agency, pursuant to a collaborative agreement with the Department, shall be subject to public disclosure.

(c) The midwifery birth center shall notify the Department in writing within seven days of failure to be accredited, re-accredited or the loss of accreditation by the accreditation agency.

 

Effective Date: 
Wednesday, November 13, 2019
Statutory Authority: 
Public Health Law, Sections 2801 and 2803(11)

Section 795.12 - Application for establishment

Section  795.12 Application for establishment.

(a) An application to the Public Health and Health Planning Council (Council) for establishment of a midwifery birth center, as required by law, shall be in writing on forms provided by the Department and executed by the chief executive officer or other officer duly authorized by the proposed operator. An original and eight copies shall be filed with the Council through the project management unit in the Department’s central office in Albany, which shall transmit one copy to the health systems agency having geographic jurisdiction.

(b) Applications to the Council shall contain information and data with reference to:

(1) the public need for the existence of the proposed midwifery birth center at the time and place and under the circumstances proposed;

(2) the character, experience, competency and standing in the community of the proposed incorporators, directors, stockholders, sponsors, individual operators or partners;

(3) the financial resources and sources of future revenue of the midwifery birth center to be operated by the applicant;

(4) the fitness and adequacy of the premises and equipment to be used by the applicant for the proposed midwifery birth center; and

(5) such additional pertinent information and documents necessary for the Council’s consideration, as determined by the Department.

 

Effective Date: 
Wednesday, November 13, 2019
Statutory Authority: 
Public Health Law, Sections 2801 and 2803(11)