Organization and Management Standards for Birthing Centers

PURPOSE: This rule establishes standards for the operation of birthing centers in order to provide care in a safe environment. (1) The center shall have a governing body which may be individual owner(s), partnership, corporate body, association or public agency. (A) The governing body shall have full legal responsibility for determining, implementing and monitoring policies governing the center’s total operation and for ensuring that the policies are administered in a manner to provide acceptable care in a safe environment. (B) The governing body shall select and employ one (1) of the following as an administrator: a physician licensed in Missouri, a certified nurse-midwife (CNM), a registered nurse licensed in Missouri or an individual with a bachelor’s degree in a related field and at least one (1) year of administrative experience in health care. (C) The governing body shall require that an individual who complies with subsection (1)(B) of this rule shall be in charge when the administrator is unavailable in person or by telecommunications. (D) Governing body bylaws shall acknowledge that duly appointed representatives of the department shall be allowed to inspect the center operation at any time, with consideration for client privacy and confidentiality. (E) Bylaws of the governing body shall require that the clinical staff, center personnel and all auxiliary organizations directly or indirectly be responsible to the governing body through the administrator. (F) The governing body, through the administrator, shall establish criteria for the content of patients’ records, provision for their timely completion and disciplinary action on occasion of noncompliance. (G) The governing body shall ensure that the birthing center abides by all applicable state and local laws. (2) The administrator shall organize the administrative functions of the center and establish a system of authorization, record procedures and internal controls. (A) The administrator shall be responsible for establishing effective security measures to protect patients, employees and visitors. (B) The administrator is responsible for assuring that all patients admitted to the center are under the care of a physician or CNM practicing pursuant to a collaborate agreement with a physician who is a member of the clinical staff. (C) A certificate of live birth shall be filed in accordance with section 193.085, RSMo. (D) The administrator shall develop procedures and have a written agreement with a licensed ambulance service for emergency transportation. If a written agreement with the ambulance service cannot be achieved due to reasons that are neither regulatory or statutory, the administrator can request a waiver or mediation from the department. (E) The administrator shall have procedures and a written transfer agreement with a hospital providing emergency, obstetrical and newborn services. If a written agreement with a licensed hospital cannot be achieved due to reasons that are neither regulatory or statutory, the administrator can request a waiver or mediation from the department. Peer review report may be submitted as evidence for mediation. (F) The administrator shall be responsible for a written plan for evacuation of patients and personnel in the event of fire, explosion or natural disaster. The plan shall be kept current and all personnel shall be knowledgeable of the plan. (G) The administrator shall be responsible for developing, enforcing and posting written policies which prohibit smoking throughout the birthing center. (H) Smoking or open flames shall be prohibited in any room or compartment where flammable liquids, combustible gases or oxygen are used or stored and in any other hazardous location. These areas shall be posted with NO SMOKING OR OPEN FLAME signs. (I) The administrator shall establish a program for identifying and preventing infections and for maintaining a safe environment. The center shall be responsible for identifying infections up to thirty (30) days postpartum in the mother and the infant unless and until they are transferred to another health-care provider prior to thirty (30) days. Infectious and pathological wastes shall be segregated from other wastes at the point of generation and shall be placed in distinctive, clearly marked, leak-proof containers or plastic bags appropriate for the characteristics of the infectious wastes. Containers for infectious waste shall be identified with the universal biological hazard symbol. All packaging shall maintain its integrity during storage and transport. Infectious waste shall be disposed of in accordance with provisions of 10 CSR 80-7.010. (J) The administrator shall establish policies and procedures for the handling, processing, storing and transporting of clean and dirty laundry. The facility may provide laundry services on-site or utilize contract services. (K) The administrator shall develop written personnel policies which contain at least the following: 1. Provision for orientation of all personnel to the policies and objectives of the center and participation by all personnel in appropriate employee training; 2. Provision for periodic evaluation of employees’ performance including clinical skills, resuscitation and use of equipment; and 3. Provision for written job descriptions, including job qualifications system for the completion and storage of medical records. (L) A personnel record shall be maintained on each employee and shall include documentation of each employee’s orientation, education, training and health information, as well as verification of current licenses for physicians, registered nurses and licensed practical nurses and documentation of certification for nurse-midwives. (3) Clinical practice guidelines for the management of routine and emergency care of the mother and her fetus/newborn in pregnancy, birth and postpartum until discharge from care by the center, whether through completion of the program or referral or transfer to other levels of care, shall be drafted by a physician or certified nurse midwife who has clinical staff membership at the birthing center. The guidelines shall be available on-site at all times. Documentation of periodic review and revision are required. (A) Clinical staff membership shall include physicians or CNMs, or both, but, as defined by the birth center bylaws, may also include other health professionals to provide service at the birth center. A physician or CNM practicing pursuant to a collaborative practice agreement with a physician shall be in attendance and responsible for intrapartum management. (B) On a form approved by the governing body, each health professional requesting clinical staff membership shall submit a written application to the administrator of the center. Each application shall be accompanied by evidence of education, training, professional qualification, health status certification and licensure. (C) A written procedure shall be established for recommending to the governing body delineation of privileges; curtailment, suspension or revocation of privileges; and appointments and reappointments to the clinical staff. The governing body, acting upon recommendations of the clinical staff, shall approve or disapprove appointments. Written criteria shall be developed for privileges extended to each member of the clinical staff. (D) Each birth center shall have at least one (1) physician who is responsible for the following: 1. Sign collaborative practice agreement and meet any other requirements of Missouri law for collaborative practice; 2. Review and sign clinical practice guidelines and risk assessment criteria at least annually; and 3. Be available in person or by telecommunication for consultation. (4) The center shall maintain a system for the completion and storage of medical records. (A) The daily patient roster shall be retained for two (2) years. (B) The medical record shall contain 1. A unique identifying medical record number; 2. Client identifying information; 3. Allergies; 4. Consent; 5. Maternal history; 6. Maternal and newborn physical examinations; 7. Laboratory test results; 8. Initial risk assessment and periodic updates; 9. Interval prenatal evaluations; 10. Problem identification, plan, and follow-up; 11. Labor and birth records, including apgars; 12. Newborn and postpartum recovery records; 13. Medication record, including any drug, and the dose, time, date and person administering; 14. Discharge plan; and 15. Postpartum and infant follow-up visits up to thirty (30) days after the birth or documentation of transfer to another health care provider. (C) All medical records shall be safeguarded against loss and unofficial use. Medical records for adults and newborns shall be retained as required by the statute of limitations under section 516.105, RSMo. (D) Medical records are the property of the birthing center and shall not be removed from the center except by court order, subpoena, for microfilming or for off-site storage approved by the governing body. Information provided for statistical purposes shall contain the unique identifying number, not the patient’s name. (5) Patient care services shall be under the direction of a physician or a CNM practicing pursuant to a collaborative practice arrangement with a physician. (A) Women registering for care at the birthing center and their families shall be informed and shall provide written acknowledgment that they have been informed of the benefits and risks of the services available at the center. They shall be made aware of the risk criteria used for admission and referral. (B) Birth center clients are limited to those women who are initially determined to be at low maternity risk and who are evaluated regularly throughout pregnancy to assure that they remain at low risk for a pregnancy outcome. 1. Each birth center shall establish a written risk assessment system which shall be a part of the clinical practice guidelines. The individual risk assessment shall be included in the client’s medical record. 2. The general health status and risk assessment shall be determined by a physician, CNM or other advanced practice nurse after obtaining a detailed medical history, performing a physical examination and taking into account family circumstances and other social and psychological factors. The client shall be transferred to a hospital if complications occur requiring medical or surgical intervention under the center’s written risk criteria. (C) The center shall provide at least one (1) CNM or physician for each three (3) women in active labor. In addition a qualified staff member shall be available for each client during the entire time the client is in the birth center. All clinical staff shall provide services during labor and delivery in accordance with the policies developed by clinical staff and approved by the governing body. (D) Qualified personnel and clinical staff of the birth center shall be trained in infant and adult resuscitation and recertified according to standards set by the American Heart Association and the American Pediatric Association. (E) A primary care giver shall remain on the premises and be immediately available for assistance to the patient during labor, delivery and immediate postpartum stages. (F) A primary care giver shall be responsible for ensuring and documenting prenatal care, health history, physical examination, and appropriate laboratory studies which shall be placed in the medical record at time of admission in preparation for delivery. (G) A patient shall meet discharge criteria as defined in the clinical practice guidelines prior to discharge from the facility. (H) Labor shall not be inhibited, stimulated or augmented with chemical agents during the first or second stage of labor. (I) General and induction anesthesia shall not be administered. Local and pudendal anesthesia may be administered by a physician or CNM practicing pursuant to a collaborative practice arrangement with a physician if use of the drugs conforms with Missouri law and written clinical practice guidelines of the birth center. (J) A program for prompt follow-up care and postpartum evaluation after discharge shall be developed and implemented. The follow-up shall include assessment of infant health including physical examination, laboratory screening tests at appropriate times, maternal postpartum status, instruction in child care including immunizations, referral to sources of pediatric care, provision of family planning services, and assessment of mother-child relationship including breast feeding. (K) The center shall be responsible for detection of Rh incompatibility and administration of RhoGAM as appropriate. (L) At a minimum, there shall be provision for nutritious liquids and snacks in accordance with 19 CSR 20-1.010. (M) Prophylactic eye treatment as required in section 210.070, RSMo shall be provided. (N) Drugs shall be stored and handled under proper security SENIOR SERVICES and environmental conditions and shall be accessible only to authorized persons. Drugs shall be administered and disposed only by licensed practitioners in accordance with applicable state laws and rules. The use of IV’s shall be restricted to hydration only or to the establishment of a central line prior to transport to emergency facilities. No IV drugs such as pitocin shall be used for inducement or augmentation of labor. (O) An emergency drug kit shall be available which includes oxygen, a Deelee suctioning trap or other appropriate equipment for emergency suctioning. (P) An adequate supply of sterile items shall be available. (6) The birthing center shall provide a quality assurance program that includes all health and safety aspects of patient care for both mother and newborn and shall include a review of appropriateness of care. Results of the quality assurance program shall be reviewed at least quarterly by the governing body. (A) The quality assurance program shall include, but not be limited to, the following: 1. A review of the medical record; 2. A determination that every mother-infant pair have an identified source of primary care and have available methods by which to contact that individual after discharge; 3. Incidences of morbidity and mortality of mother and infant; 4. Postpartum infections; 5. A review of all cases transferred to a hospital for delivery, care of the infant or postpartum care of the mother; 6. A review of all cases that resulted in a length of stay of more than twelve (12) hours beyond the birth of the baby; 7. Incidents, problems, and potential problems identified by the staff of the birthing center; and 8. Problems with compliance with state laws and rules. (B) The quality assurance program shall show evidence of action taken as a result of the identification of a problem, including documented outcome and evaluation. (7) A birthing center shall provide for essential laboratory services, including, but not limited to, hemoglobin or hematocrit, urinalysis, microscopic analysis and culture, blood type and Rh, syphilis, hepatitis B, rubella, pap smears and pregnancy tests. (A) Laboratory services may be provided on-site or through a certified laboratory in accordance with federal regulations. (B) When services are provided by arrangement with an outside provider, the original copy of the signed and dated report shall become part of the mother’s permanent record at the birthing center. (C) Results of tests completed at the birthing center shall be entered, dated and signed in the mother’s or child’s record by the individual who performed the test. Abnormal test results shall be followed up by the primary provider in accordance with birth center risk criteria and clinical practice guidelines. AUTHORITY: section 197.225, RSMo 1994.* Emergency rule filed May 1, 1995, effective May 10, 1995, expired Sept. 7, 1995. Original rule filed May 1, 1995, effective Nov. 30, 1995. Emergency amendment filed June 19, 1998, effective July 1, 1998, expired Feb. 25, 1999. Amended: Filed June 19, 1998, effective Jan. 30, 1999. *Original authority 1975, amended 1986.