Previous

Article 9
Free-standing Birth Centers

Section

400. (Repealed).

401. Determination of a free-standing birth center; scope of services.

402. (Repealed).

403. General service requirements; restrictions.

404. Application.

405. Administration.

410. (Repealed).

415. Clinical staff and support staff.

416. Client management.

418. Evaluation and improvement of quality of care.

420. Drugs and biologicals.

425. Medical records.

430. Equipment and supplies.

435. Physical environment.

437. Physical plant.

440. (Repealed).

442. (Repealed).

445. (Repealed).

446. Determination of low-risk maternal client.

449. Definitions.

7 AAC 12.400. Licensure

Repealed 11/19/83.

Editor's note: The substance of this regulation was revised and reorganized as part of a comprehensive revision of this chapter, effective 11/19/83, Register 88, and appears in 7 AAC 12.610. The history note at the end of that section does not reflect the history of this section.

7 AAC 12.401. Determination of a free-standing birth center; scope of services

(a) Subject to (b) of this section, the department will consider an entity to be a free-standing birth center if the entity

(1) is a publicly or privately owned facility, place, or institution that is constructed, renovated, leased, rented, or otherwise established;

(2) is a place

(A) where midwifery services are provided;

(B) that is physically separate from acute care obstetrical services;

(C) that is administratively autonomous from a hospital or other health facility; and

(D) that has a separate and required staff, including administrative staff;

(3) is located within 20 miles by road from a hospital that provides the services required under 7 AAC 12.405(g) ; and

(4) provides planned, nonemergency midwifery services for low-risk maternal clients

(A) away from the client's residence; a birth center may not offer or provide labor or delivery services at a location other than its licensed premises;

(B) after a documented period of prenatal care for a normal, uncomplicated pregnancy that is determined to be low-risk through physical examinations, and through risk assessments conducted in accordance with the standards developed under 7 AAC 12.403(f) ; and

(C) who do not require hospitalization.

(b) Notwithstanding (a)(2)(B), (C), and (D) of this section, a hospital or other health facility may own and operate a birth center if

(1) the birth center is physically separate from the hospital's obstetrical unit;

(2) each primary care provider in the birth center is a midwife;

(3) the birth center operates as an administratively autonomous department and is responsible for reporting directly to the governing body of the hospital or health facility on all matters concerning the birth center; and

(4) the birth center is licensed separately.

(c) In addition to the provisions of 7 AAC 12.401 - 7 AAC 12.449, a free-standing birth center is subject to the applicable requirements of 7 AAC 12.600(a) , (e), and (g).

History: Eff. 11/19/83, Register 88; am 9/30/2007, Register 183

Authority: AS 47.32.010

AS 47.32.030

7 AAC 12.402. Penalties

Repealed 11/19/83.

Editor's note: The substance of this regulation was revised and reorganized as part of a comprehensive revision of this chapter, effective 11/19/83, Register 88, and appears in 7 AAC 12.620. The history note at the end of that section does not reflect the history of this section.

7 AAC 12.403. General service requirements; restrictions

(a) A birth center may provide midwifery services only to a woman who is a low-risk maternal client under 7 AAC 12.446.

(b) If the midwife providing midwifery services in a birth center is a

(1) direct-entry midwife, the birth center shall ensure that the direct-entry midwife provides midwifery services in accordance with the requirements of AS 08.65 and 12 AAC 14, and within the scope of practice set out under AS 08.65 and 12 AAC 14; and

(2) certified nurse midwife, the birth center shall ensure that the certified nurse midwife provides midwifery services in accordance with the requirements of AS 08.68 and 12 AAC 44, and within the scope of practice set out under AS 08.68 and 12 AAC 44.

(c) The birth center shall ensure that its policies and procedures clearly describe the rights and responsibilities of a client and her family or support person. The birth center shall explain those rights and responsibilities to the client and the client's family or support person before or upon admission for care.

(d) In addition to implementing the client rights set out in 7 AAC 12.890, the birth center shall

(1) inform each client of the right to request transfer to a hospital for care, and advise the client that the birth center will make arrangements for any transfer;

(2) inform each client of the right to refuse transfer if recommended by the midwife, and advise the client that the risks of refusing transfer include maternal or fetal death; the birth center shall document in writing any refusal described in this paragraph; and

(3) provide each client with a written statement, including a glossary of terms, regarding

(A) fees for services and responsibilities for payment;

(B) the established criteria for admission to, and continuation in, the birth center program of care;

(C) the benefits, risks, and eligibility requirements for an out-of-hospital labor and birth;

(D) the services that are provided by the birth center and those that are provided by contract, consultation, or referral;

(E) the identity and qualifications of care providers, consultants, and related services and institutions, including the type of current license or certification held by the midwife providing care;

(F) all diagnostic procedures, reports, recommendations, and treatments;

(G) the birth center's plan for providing emergency and nonemergency care to the client or newborn if a complication occurs during pregnancy or labor;

(H) the approximate amount of time required to reach the nearest hospital if emergency transfer is necessary;

(I) information regarding health care options, and the state of the science regarding each option, to assist the client in making informed decisions;

(J) the client's rights regarding participation in

(i) decisions relating to the plan for management of her care and any changes in that plan, including referral and transfer to other practitioners or other levels of care if requested by the client or if the care required is not within the midwife's scope of practice; and

(ii) research or student education programs;

(K) the birth center's plan for hearing grievances;

(L) the client's right to submit a complaint to the department regarding the care provided by the birth center, including information about how to contact the department; and

(M) whether the birth center and clinical staff have malpractice liability insurance, if the client requests that information.

(e) The birth center shall provide, or demonstrate the availability at another appropriate entity of, a range of services necessary to meet the physical, emotional, socioeconomic, informational, and medical needs of clients and newborns, as those needs relate to care at the birth center, including

(1) an orientation to the fees and services of the birth center as described in (d) of this section;

(2) prenatal care; prenatal care may be provided by a practitioner at another site, regardless of whether that practitioner is associated with the birth center;

(3) an educational program for pregnancy, labor, breastfeeding, newborn care, parenting, self-care, self-help, and sibling preparation;

(4) laboratory service;

(5) 24-hour telephone consultation;

(6) library resources;

(7) intrapartum care;

(8) light nourishment during labor and postpartum care;

(9) immediate postpartum care;

(10) home or office follow-up for the client and newborn;

(11) exercise programs;

(12) parent support groups;

(13) postpartum classes;

(14) family planning;

(15) well baby care;

(16) information regarding the availability of circumcision procedures at another appropriate entity;

(17) a nursing mother support program;

(18) well woman gynecological care; and

(19) public education.

(f) The birth center shall develop and implement a risk assessment tool to be completed for each client at admission and at regular intervals after admission, and a method or plan for consultation if necessary, to determine whether a client is a low-risk maternal client under 7 AAC 12.446. The risk assessment tool must include standards that, at a minimum, address

(1) whether the physical examination conducted at admission or a physical examination conducted after admission detected any abnormalities;

(2) the client's menstrual history;

(3) any past pregnancies, including, for each pregnancy,

(A) the length of the pregnancy at birth;

(B) any complications during pregnancy or labor;

(C) the length of labor;

(D) the type of delivery; and

(E) the place of delivery;

(4) the client's medical history, including any history of

(A) diabetes;

(B) hypertension;

(C) heart disease;

(D) autoimmune disorders;

(E) kidney disease;

(F) neurological disorders;

(G) epilepsy;

(H) depression;

(I) postpartum depression;

(J) psychiatric problems;

(K) hepatitis;

(L) liver disease;

(M) asthma;

(N) tuberculosis or other pulmonary disorders;

(O) varicosities;

(P) phlebitis;

(Q) thyroid dysfunction;

(R) blood transfusions;

(S) bleeding disorders;

(T) trauma;

(U) domestic violence;

(V) allergies;

(W) abnormal Papanicolaou (PAP) tests;

(X) uterine anomalies;

(Y) surgery;

(Z) anesthetic complications;

(AA) Rh sensitivity;

(BB) infertility;

(CC) use of prescription or nonprescription medications;

(DD) alcohol use;

(EE) tobacco use;

(FF) substance abuse; and

(GG) use of vitamins, herbs, or other nutritional, dietary, or health supplements;

(5) any pertinent family history related to diabetes, hypertension, heart disease, bleeding disorders, kidney disease, stroke, or other genetic disorders or family conditions that may be significant; and

(6) infection history, including

(A) exposure to tuberculosis;

(B) whether the client or the baby's father has a history of acquired immune deficiency syndrome (AIDS), the human immunodeficiency virus (HIV), genital herpes, or any sexually transmitted disease;

(C) whether the client has a history of gram positive Group B Streptococcus; and

(D) whether the client has experienced any rash or viral illness since her last menstrual period.

(g) The birth center shall have a written plan for evaluating the services provided, for assessing outcomes, and for making necessary changes based on each evaluation.

(h) Before admitting a client, the birth center shall ensure that the client has received ongoing prenatal care. If a client requests the services of the birth center late in pregnancy and has no evidence of ongoing prenatal care, the birth center shall ensure that

(1) the risk assessment conducted in accordance with the standards developed under (f) of this section includes necessary laboratory testing;

(2) the client establishes regular and ongoing prenatal care; and

(3) the period of time before admission for labor and delivery is adequate to establish the client's appropriateness for birth center services.

(i) The birth center shall develop and implement a policy approved by the governing body that provides the protocols, procedures, and parameters for acceptance of a client who requests services late in pregnancy and who has not had regular ongoing prenatal care.

(j) The birth center shall develop and implement policies and procedures that

(1) include screening for domestic violence or other relationship safety issues at least once during each trimester; and

(2) describe how the birth center will address a domestic violence or relationship safety issue if encountered, including

(A) informing the client about available resources for assistance; and

(B) reporting to authorities, if appropriate.

(k) The birth center shall develop and implement a policy and procedures manual that includes all aspects of birth center practice and care, and shall ensure that the manual is available to the clinical and support staff at all times.

(l) The birth center shall develop written practice protocols that reflect how the birth center will implement applicable standards of practice. The birth center shall ensure that the governing body approves the practice protocols. The practice protocols must

(1) include a comprehensive, step-by-step guide to care that addresses specific conditions that are expected or that may arise during prenatal care, delivery, or postpartum care; and

(2) be designed to ensure and enhance safe, high-quality care.

(m) Surgical procedures provided in a birth center must be limited to those normally performed during and after uncomplicated childbirth, and must be performed in accordance with the practice protocols developed under (l) of this section. A surgical procedure that includes operative obstetrics or a cesarean section may not be performed in a birth center.

(n) General or conduction anesthesia may not be administered in a birth center. Local anesthesia may be administered, and an episiotomy and episiotomy or laceration repair may be provided, if performed by a midwife in accordance with that midwife's applicable scope of practice as required under (b) of this section. The birth center shall establish and implement policies and procedures that address the administration of local anesthesia, the provision of episiotomies, and episiotomy or laceration repair.

(o) Labor may not be induced, stimulated, or augmented with oxytocin or any other pharmacological agent. If there is fetal distress or a prolapsed cord, the birth center may use a pharmacological agent to inhibit labor while making arrangements to transport the client to a hospital.

(p) A birth center may not use vacuum extractors, forceps, or ultrasound imaging in the birth center. Except as provided in 7 AAC 12.430(a) (3)(G), a birth center may not use recorded electronic fetal monitors in the birth center.

(q) Each client and newborn must be discharged, or transferred if necessary, within 24 hours after the newborn's birth. If a longer stay becomes necessary for a client or newborn, the birth center must

(1) document in the medical record that the client and newborn were expected, at the time of admission, to be discharged within 24 hours after the newborn's birth; and

(2) describe in the report required under 7 AAC 12.405(j) (10) the reason for any stay beyond 24 hours after the newborn's birth.

History: Eff. 11/19/83, Register 88; am 9/30/2007, Register 183

Authority: AS 47.32.010

AS 47.32.030

7 AAC 12.404. Application

Before providing services, a free-standing birth center must have a current license issued under 7 AAC 12.605 - 7 AAC 12.610. In addition to meeting the requirements of 7 AAC 12.605 - 7 AAC 12.610, the applicant shall provide the following information with the initial application for a license, and with each application for renewal:

(1) identification of the proposed service area;

(2) an assessment of the demographic data and vital statistics of the community served, including

(A) the population to be served;

(B) environmental factors that might affect access to the birth center or transfer to a hospital;

(C) availability of and access to maternal and newborn services, including

(i) practitioners;

(ii) hospital obstetrics and newborn services;

(iii) home birth services;

(iv) family-centered maternity care programs;

(v) birth rooms and suites;

(vi) clinics for disadvantaged families;

(vii) laboratory services;

(viii) supplementary social and welfare services;

(ix) childbirth education; and

(x) parent support programs;

(D) the birth center's impact on the community and the needs of childbearing families in the population served; and

(E) for an application for license renewal,

(i) changes in the demographic data and vital statistics under (A) - (C) of this paragraph since the previous application was submitted;

(ii) the number of births at the birth center during the previous 12 months;

(iii) the number of births with complications that required transfer of the newborn to a hospital during the previous 12 months; and

(iv) the number of births with complications that required transfer of the client to a hospital during the previous 12 months.

History: Eff. 9/30/2007, Register 183

Authority: AS 47.32.010

AS 47.32.020

AS 47.32.030

AS 47.32.040

AS 47.32.050

AS 47.32.100

AS 47.32.110

7 AAC 12.405. Administration

Next