Or. Admin. Code § 333-076-0670

Current through Register Vol. 63, No. 12, December 1, 2024

Section 333-076-0670 - Policies and Procedures

Each Center must have a detailed Policies and Procedures Manual in easily accessible form, that has been approved by the governing body or person. In order to be approved by the Division for licensing purposes, these policies and procedures must meet North American Registry of Midwives (NARM) standards. All the above noted policies must be made available to representatives of the Division on request, and subject to their approval. Failure of approval will be adequate reason for the finding of deficiencies that must be corrected for continuation of licensure. The policies must be implemented as applicable, and there must be documented evidence of implementation of the above noted policies. The policies and procedures that will be developed as applicable and implemented include:

(1) A detailed organizational chart that shows the governing body or person, and clearly delineates lines of authority, responsibility and accountability for each position included in the organization, including volunteers.

(2) Staffing - The governing body or person must ensure, through the policies and procedures, that there are adequate numbers of qualified and, where required, licensed or registered personnel on duty and immediately available to provide services intended for mothers and families, and to provide for safe maintenance of the Center.

(3) Detail of procedures to be permitted, and by whom, and method of determining the qualifications and privileges of all personnel. Staff will be required to provide documented evidence of such qualifications. Such evidence must be maintained by the Center.

(4) System for ensuring 24-hour coverage of the Center, including constant attendance by qualified attendants while a client is in the Center.

(5) System for training and for continuing education for all personnel according to their assigned duties and evaluation of skills consistent with the individual practitioners' scopes of practice. All personnel providing direct client care must be trained in cardiopulmonary resuscitation (CPR) and there must be a record of current CPR certification. In addition there must be present at each birth one practitioner trained in care and resuscitation of the newborn.

(6) System delineating how and when the Center will seek consultation with clinical specialists in obstetrics and pediatrics in order to ensure that all services, policies, and procedures meet North American Registry of Midwives (NARM) standards.

(7) Protocol for referral or transfer to appropriate health care facilities all clients whose risk status exceeds that for "low risk pregnancy."

(8) Procedures by which risk status will be assessed during the antepartal, intrapartal, and post partum period, and the identification of medical and social factors which exclude women, fetuses and newborns from the low-risk group; and for the annual review of these methods. Documentation of such assessments must be maintained in client's clinical records. Only those clients for whom prenatal and intrapartum history, physical examination, and laboratory screening procedures have demonstrated a low risk pregnancy and labor will be accepted into the Center for childbirth.

(9) System by which the Center will ensure the presence and continuing maintenance, as recommended by the manufacturer(s), of equipment needed to provide low risk maternity care, and to initiate emergency procedures in life-threatening events to the mother or baby.

(10) Plan and protocols for ensuring that emergency situations in either the mother or newborn are recognized in a timely fashion, and care is provided within the limits of the practitioner's scope of practice.

(11) System delineating how emergency transportation will be promptly available for transport of the mother and/or newborn to a health care facility with the capacity for emergency care of women, in all the stages of labor, and newborns. The written policy must include a listing of situations for the mother and/or newborn that would have the potential to necessitate emergency transfer. The policy must also include the requirement that a transfer plan for each patient be developed.

(12) Systems for ensuring the orientation and education of women and families registering for care at the Center so that they will be informed as to the benefits and risks of the services available to them at the Center and the qualifications and licensure status of practitioners at the Center. They must be fully informed of the risk criteria as defined in OAR 333-076-0650 and provide written consent. The client, as a part of the informed consent, must also agree in advance to transfer to another clinician or appropriate health care facility, should the need occur due to the development of unexpected risk factors after admission to the Center. The client must be informed of the benefits and risks of such a transfer.

(13) System for the sterilization of equipment and supplies, unless only pre-packaged and pre-sterilized items are used.

(14) System to ensure the performance of appropriate laboratory studies and to ensure that the results are available in a timely manner.

(15) System for the storage and administration of drugs. All medications must be prescribed and/or administered within the individual practitioner's licensure and/or scope of practice.

(16) System to ensure the timely administration of Rh immune globulin to the mother, where applicable.

(17) System to ensure the timely appropriate administration of Vitamin K to the newborn, according to rules of the Division.

(a) The purpose of ORS 433.303 to 433.314 is to protect newborn infants against hemorrhagic disease of the newborn.

(b) The Vitamin K forms suitable for use are forms of Vitamin K1 (Phytonadione), available in injectable or oral forms: as Mephyton for oral use, or as aquamephyton or konakion for injectable use. The Vitamin K dose is to be administered within the first 24 hours of delivery. Menadione (Vitamin K3) is not recommended for prophylaxis and treatment of hemorrhagic disease of the newborn.

(c) The dose of any of the Vitamin K1 forms to be administered is one dose of 0.5 to 1.0 mg., if given by injection, or one dose of 1.0 to 2.0 mg. if given orally.

(d) A parent may, after being provided a full and clear explanation, decline to permit the administration of Vitamin K based on religious tenets and practices. In this event, the parent must sign a form acknowledging his/her understanding of the reason for administration of Vitamin K and possible adverse consequences in the presence of a person who witnessed the instruction of the parent, and who must also sign the form. The form must become a part of the clinical record of the newborn infant.

(18) System to ensure the timely and appropriate collection of blood from the newborn for testing by the Oregon State Public Health Laboratory, Newborn Screening Program, for the Metabolic Diseases listed in 333-024-0210.

(19) System to ensure that pulse oximetry screening is performed on every newborn infant delivered at the Birthing Center before the infant is discharged in conformance with the following requirements:

(a) The pulse oximetry screening must be performed using evidence-based guidelines such as those recommended by Strategies for Implementing Screening for Critical Congenital Heart Disease, AR Kemper et al., Pediatrics 2011;128(5): e1259-1267.

(b) The Birthing Center must have policies and procedures based on the guidelines required by subsection (a) of this section for:

(A) Determining what is considered a positive screening result; and

(B) Determining what follow-up services, treatment or referrals must be provided if a newborn infant has a positive screening result.

(c) A Federal Drug Administration (FDA) approved motion tolerant pulse oximeter must be used.

(d) The pulse oximetry screening must be performed no sooner than 24 hours after birth or as close to discharge of the newborn infant as possible.

(e) Before performing pulse oximetry screening on newborn infants, individuals must have received training on how to correctly operate the pulse oximeter and the policies and procedures associated with the screening. The Birthing Center must document this training.

(f) If a newborn infant is admitted to a hospital as the result of a transfer from the Birthing Center before a pulse oximetry screening is performed, the hospital from which the newborn infant is discharged to home is responsible for performing the screening.

(g) The Birthing Center must provide the following notifications and document them in the newborn infant's medical record:

(A) Prior to the pulse oximetry screening, notify a parent or legal representative of the newborn about the reasons for the screening and the risks and consequences of not screening.

(B) Following the pulse oximetry screening, notify the health care provider responsible for the newborn infant and the infant's primary care provider of the results of the screening.

(C) Following the pulse oximetry screening and prior to discharge, notify a parent or legal representative of the newborn infant of the screening result, an explanation of its meaning and, if it is a positive screening result, provide information about the importance of timely diagnosis and intervention.

(h) A parent or legal representative of a newborn infant may decline pulse oximetry screening and, if screening is declined, the Birthing Center must document the declination in the newborn infant's medical record.

(i) Following the pulse oximetry screening, the Birthing Center, in accordance with the applicable standard of care, must provide any appropriate follow-up services or treatment for the newborn infant if necessary or provide a referral to a parent or legal representative of the newborn for follow-up services or treatment if necessary.

(j) The Birthing Center must document in the newborn infant's medical record that the screening was performed, the screening result, the names of the health care providers who were notified of the screening result, and any follow-up services or treatment or referral for services or treatment.

(k) No newborn infant may be refused screening because of the inability of a parent or legal representative to pay for the screening.

(20) Protocol delineating the steps to ensure the prompt and safe evacuation of the Center in the event of emergency situations, such as fire. The Center must ensure the evaluation of staff in managing such situations by periodic drills for fire, and/or other emergencies. Such drills must be documented.

(21) System of infection control to address the prevention and early recognition of the possibility of infection, and timely and acceptable methods of control. This includes written documentation of the problem, and measures taken for control, and must at least meet the requirements of the rules of the Division. Documentation must also include methods for the control and prevention of cross-infection between clients and services in accordance with 2003 Center for Disease Control and Prevention "Guidelines for Environmental Infection Control in Health-Care Facilities."

(22) System to be used for the prevention of Ophthalmia Neonatorum in the newborn OAR 333-019-0036(2). Prophylaxis for Gonococcal Ophthalmia Neonatorum:

(a) The practitioner attending the birth of an infant must, after evaluating the infant as being at risk and within two hours of delivery, instill appropriate prophylactic antibiotic ointment from single patient use applicators into each eye of the newborn infant;

(b) Parent(s) refusing to allow prophylaxis for their infant(s) must be informed, by the attending Health Care Provider, of the risks attendant to such action and must sign a witnessed affidavit to testify that they have been so informed and nonetheless refuse to allow prophylaxis.

(c) If Vitamin K and/or Gonococcal Ophthalmia Neonatorum Prophylaxis cannot be administered by the individual delivering the newborn, methods must be described to ensure that these services are arranged by referral.

(23) System to ensure that appropriate vital records are filed according to the rules of the Division.

(24) System for a semi-annual clinical record audit to evaluate the care process and outcome.

Or. Admin. Code § 333-076-0670

HD 26-1985, f. & ef. 10-28-85; HD 2-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0420; PH 15-2006, f. & cert. ef. 6-27-06; PH 18-2013(Temp), f. 12-31-13, cert. ef. 1-1-14 thru 6-29-14; PH 18-2014, f. & cert. ef. 6-17-14

Stat. Auth.: ORS 441.025 & 442.015

Stats. Implemented: ORS 441.025 & 442.015