16 Del. Admin. Code § 3365-1.0

Current through Register Vol. 28, No. 5, November 1, 2024
Section 3365-1.0 - Definitions
1.1 The following words and terms, when used in this regulation, should have the following meaning unless the context clearly indicates otherwise:

"Acute Postpartum Period" means a minimum of two hours following delivery of the placenta and until the patient is clinically stable.

"Administrator" means a person who is delegated the responsibility for the implementation and proper application of policies, programs and services established for the birthing center.

"Birthing Center" means a public or private health facility other than a hospital which is established for the purpose of delivering babies and providing immediate postpartum care. Non-emergency births are planned to occur away from the mother's usual residence following a documented period of prenatal care for a normal uncomplicated pregnancy which has been determined to be low risk through a formal risk scoring examination.

"Birthing Service" means the prenatal, intrapartum and postpartum care provided for individuals with uncomplicated pregnancy, labor and vaginal birth and newborns during the recovery period. Services provided in a birthing center shall be provided by a licensed physician, certified nurse midwife or certified professional midwife and a registered nurse. Services provided in a birthing center shall be limited in the following manner:

(1) surgical services shall be limited to those normally performed during uncomplicated childbirth, such as episiotomy and repair, and shall not include operative obstetrics or cesarean sections;
(2) surgical repair of a fourth degree laceration is beyond the scope of practice for the midwife;
(3) labor shall not be inhibited, stimulated or augmented with chemical agents during the first or second stage of labor;
(4) systemic analgesia may be administered and local anesthesia for pudendal block and episiotomy repair may be performed;
(5) general and conductive anesthesia shall not be administered at birthing centers;
(6) patients shall not routinely remain in the facility in excess of twenty-four (24) hours.

"Bylaws" means a set of rules adopted by a birthing center for governing the facility's operation.

"Certified Midwife" means either a Certified Nurse Midwife or a Certified Professional Midwife as defined in these regulations.

"Certified Nurse Midwife" means an individual who is currently licensed to practice nursing as a nurse midwife pursuant to 24Del.C.Ch. 19.

"Certified Professional Midwife" means an individual who is currently certified to practice midwifery pursuant to 16Del.C.§ 122(3) h and who holds a permit from the Division of Public Health.

"Change of Ownership (CHOW)" see "Modification of Ownership and Control (MOC)".

"Clinical Record" means a written account of all services provided to a patient by the birthing center, as well as other pertinent information necessary to provide care.

"Department" means the Delaware Department of Health and Social Services.

"Governing Body or Other Legal Authority" means the individual, partnership, agency, group, or corporation designated to assume full legal responsibility for the policy determination, management, operation and financial liability of the birthing center.

"Hospital" means a place devoted primarily to the maintenance and operation of facilities for the diagnosis, treatment or care for not less than 24 hours in any week of 4 or more non-related individuals suffering from illness, disease, injury or deformity or a place devoted primarily to providing for not less than 24 hours in any week of obstetrical or other medical or nursing care for 2 or more non-related individuals but does not include sanatoriums, rest homes, nursing homes or boarding homes.

"Immediate Jeopardy" means a crisis situation in which the health and safety of patients is at risk. It is a deficient practice which indicates an inability to furnish safe care and services.

"Legal Entity" means a business organizational structure that is recognized as such by 6Del.C. or 8Del.C.

"License" means the document issued by the Department which constitutes the authority to receive patients and perform services included within the scope of these regulations.

"Licensee" means the individual, corporation, or public entity with whom rests the ultimate responsibility for maintaining approved standards for the birthing center.

"Low Risk" means normal, uncomplicated prenatal course as determined by adequate prenatal care and prospects for a normal, uncomplicated birth as defined by reasonable and generally accepted criteria of maternal and fetal health.

"Majority Interest" means the largest percentage of ownership interest.

"Minority Interest" means any percentage of ownership less than the majority interest.

"Modification of Ownership and Control (MOC)" means the sale, purchase, transfer or re-organization of ownership rights.

"Owner" means an individual or legal entity with ownership rights of the facility.

"Ownership" means the state or fact of exclusive possession and control of the facility.

"Ownership Interest" means the percentage of ownership an individual or legal entity possesses.

"Patient" means a pregnant female who plans to deliver away from her usual residence following a documented period of prenatal care for a normal uncomplicated pregnancy which has been determined to be low risk through risk status criteria.

"Physician" means an individual currently licensed as such pursuant to 24Del.C.Ch. 17.

"Plan of Correction" means a birthing center's written response to findings of regulatory non-compliance. Plans must adhere to the format specified by the licensing agency, must include acceptable timeframes in which deficiencies will be corrected and must be approved by the licensing agency.

"Recovery Period" means that period of time starting at the birth and ending with the discharge of the patient from the birthing center.

"Registered Nurse" means an individual who is currently licensed to practice nursing pursuant to 24Del.C.

"Risk Status Criteria" means

(1) patients 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 poor pregnancy outcome;
(2) an established written risk assessment system;
(3) determination of general health status and risk assessment by a physician or certified midwife after obtaining a detailed medical history, performing a physical examination and taking into account family circumstances and other social and psychological factors;
(4) acceptance for and continuation of care throughout pregnancy and labor is limited to those women for whom it is appropriate to give birth in a setting where anesthesia is limited to local infiltration of the perineum or a pudendal block and where analgesia is limited;
(5) minimum risk factor criteria shall be applied to all patients prior to acceptance for birthing center services and throughout the pregnancy for continuation of services.

"Survey" means an inspection conducted by a representative of the Department to determine if a licensee is in compliance with Del.C. and this chapter.

"Transfer Agreement" means an agreement with a hospital which has an organized obstetrical services with an obstetrician and a pediatrician on active staff and 24-hour emergency care and cesarean section capability within thirty (30) minutes, providing such service on a continuing basis, stating that said hospital agrees to accept from the birthing center such cases as may need to be referred for whatever reason, and agrees to accept phone consultation for problems that arise in the birthing center.

16 Del. Admin. Code § 3365-1.0

12 DE Reg. 235 (08/01/08)
25 DE Reg. 777( 2/1/2022) (Final)