16 Del. Admin. Code § 3365-6.0

Current through Register Vol. 28, No. 3, September 1, 2024

Section 3365-6.0 - Patient Care

6.1 Admissions

6.1.1 Only those mothers who demonstrate the potential for a normal uncomplicated course of pregnancy and labor may be accepted for childbirth at the facility.

6.1.1.1 The facility must utilize a written risk assessment system to determine risk status criteria.

6.1.1.2 Those mothers determined to be at risk as defined in Sec. 3.2 must be referred to a physician for care.

6.1.2 All patients admitted to the facility shall be under the direct care of a member of the clinical staff and agree to remain at the facility not less than four (4) hours postpartum.

6.1.3 The facility and the patient shall have a written agreement for services which shall include:

6.1.3.1 An explanation of the services available;

6.1.3.2 An explanation of services not available, including types of anesthesia;

6.1.3.3 The location (distance and driving time) of the nearest hospital providing obstetrical/gynecological/pediatric services; and

6.1.3.4 A statement of charges for services.

6.1.4 Every woman seeking birthing center services shall have an initial assessment by a professional member of the staff to determine eligibility for admission.

6.2 Prenatal Care

6.2.1 A childbirth education program shall be provided or made available by the birthing center. The program shall include but not be limited to:

6.2.1.1 Prenatal care and its outcome;

6.2.1.2 Care of the newborn;

6.2.1.3 Instruction regarding labor and delivery; and

6.2.1.4 Preparation for participation in the childbirth process.

6.2.2 Prenatal care shall be in accordance with acceptable standards.

6.2.3 When, in the course of prenatal care, risk factors are identified which preclude childbirth at the facility, the patient shall be referred for care to a qualified physician.

6.2.4 Prenatal visits shall be scheduled:

6.2.4.1 At least every four (4) weeks until the twenty-eighth (28th) week;

6.2.4.2 At least every two (2) weeks between the twenty-eighth (28th) week and the thirty-sixth (36th) week; and

6.2.4.3 At least every week between the thirty-sixth (36th) week and delivery.

6.3 Intrapartum Care

6.3.1 A professional staff member must be present and available to the patient at all times during her stay at the facility.

6.3.2 The professional staff shall monitor the progress of labor and the condition of the patient and fetus at sufficient frequent intervals to identify abnormalities or complications at the earliest possible time.

6.3.3 If complications occur in the course of labor and delivery, it is the responsibility of the professional staff to arrange for the patient to be transferred to the hospital.

6.3.4 The family or support persons shall be instructed as needed to assist the patient during labor and delivery.

6.3.5 Interventions shall be limited to those required to accomplish a vaginal delivery.

6.3.6 Labor shall not be inhibited, stimulated or augmented with chemical agents.

6.3.7 No surgical procedures shall be performed except episiotomy, repair of episiotomy or laceration, or circumcision.

6.3.8 Systemic analgesics and local anesthesia may be administered under the following conditions:

6.3.8.1 The professional staff member who administers the systemic analgesic is legally authorized to do so;

6.3.8.2 The dosage and drug are specifically noted in the protocols for clinical services; and

6.3.8.3 The use of such drugs is in conformance with the policies and procedures of the facility and with national standards.

6.3.9 General and conduction anesthesia shall not be administered.

6.4 Postpartum Care

6.4.1 The patient shall remain at the facility a minimum of four (4) hours postpartum after a normal uncomplicated birth.

6.4.2 Postpartum care shall be delivered in accordance with acceptable professional standards and legal requirements.

6.4.3 The newborn shall be referred to a physician or a hospital for any condition requiring medical care.

6.4.4 The condition of the patient shall be monitored frequently to detect signs of hemorrhage or other complications requiring prompt transfer to a hospital.

6.4.5 The patient shall be counseled regarding breast feeding, perineal care, family planning, signs of common complications, activities and exercise, sexual relations, care and feeding of the newborn and changing family relationships.

6.4.6 A member of the facility's professional staff must be accessible to patients by telephone, twenty-four (24) hours a day.

6.4.7 The facility must make provisions for appropriate follow-up care for the patient and newborn after discharge.

6.5 Management of Emergencies

6.5.1 Criteria shall be established to determine risk status which requires medical consultation or transfer to a hospital and shall include but not be limited to:

6.5.1.1 Premature labor (occurring at less than thirty-seven (37) weeks gestation);

6.5.1.2 Development of hypertension or pre-eclampsia;

6.5.1.3 Non-vertex presentation

6.5.1.4 Failure to progress in labor

6.5.1.5 Evidence of an infectious process;

6.5.1.6 Suspected placenta previa or abruption;

6.5.1.7 Hemorrhage of greater than 500 cc of blood;

6.5.1.8 Premature rupture of the membranes (occurring within a timeframe agreed upon by the certified midwife and back-up physician in their collaborative agreement);

6.5.1.9 Suspected congenital anomaly;

6.5.1.10 Anemia consisting of less than ten (10) grams of hemoglobin per one hundred (100) milliliters of blood or thirty (30) percent hematocrit;

6.5.1.11 Persistent fetal tachycardia (heart rate greater than 160 beats per minute), repetitive fetal bradycardia (heart rate less than 120 beats per minute) or undiagnosed abnormalities of the fetal heart tones;

6.5.1.12 Rising antibody titre of any type that is known to affect fetal well-being;

6.5.1.13 Excessive need for analgesia during labor, or for anesthesia other than pudendal or local; or

6.5.1.14 Persistent hypothermia in the newborn.

6.5.2 Criteria shall be established to determine risk status which requires immediate emergency transfer to a hospital and shall include but not be limited to:

6.5.2.1 Prolapsed cord;

6.5.2.2 Uncontrolled hemorrhage;

6.5.2.3 Need for transfusion;

6.5.2.4 Placenta abruption;

6.5.2.5 Retained placenta greater than sixty (60) minutes;

6.5.2.6 Convulsions;

6.5.2.7 Thick meconium staining at the time of membrane rupture;

6.5.2.8 Apgar score of seven (7) or less at five (5) minutes;

6.5.2.9 Fetal heart rate of ninety (90) or less beats per minute for three (3) minutes;

6.5.2.10 Major anomaly of the newborn;

6.5.2.11 Respiratory distress in the newborn;

6.5.2.12 Newborn weight less than 2500 grams;

6.5.2.13 Newborn need for oxygen beyond five (5) minutes; or

6.5.2.14 Signs of prematurity.

6.6 Food Service

6.6.1 The facility may provide patients and families with nutritious liquids and snacks as needed.

6.6.2 When the facility policy allows for the preparation and/or storage of food brought in by the patients or families:

6.6.2.1 There shall be refrigerator able to maintain cold foods at a temperature of 45° Fahrenheit or lower;

6.6.2.2 There shall be a stove and/or a microwave oven;

6.6.2.3 There shall be dry storage and counter space; and

6.6.2.4 There shall be a dishwashing machine and/or a sink.

6.6.3 Food may not be stored together with medications requiring refrigeration.

6.6.4 All refrigerated food items must be labeled and dated.

6.6.5 If applicable, the facility's food services will be subject to the food establishment requirements.

6.7 Pharmaceutical Service

6.7.1 Medicines and drugs maintained at the facility shall be properly stored and secured in specifically designated cabinets, closets, drawers or storerooms.

6.7.2 Only authorized persons shall have access to storage enclosures.

6.7.3 Controlled drugs shall be stored in accordance with state and federal laws.

6.7.3.1 Records shall be kept on the receipt and disposition of all controlled substances.

6.7.4 Medicines and drugs shall not be administered to patients unless ordered by an independent licensed practitioner with prescriptive authority.

6.7.4.1 Orders for medicines and drugs must be in writing and must be signed by the prescribing licensed practitioner.

6.7.4.1.1 Verbal and telephone orders may only be received by a registered nurse, midwife, physician or pharmacist.

6.7.4.1.2 All verbal and telephone orders must be countersigned by the ordering practitioner within forty-eight (48) hours of the order.

6.7.4.2 Pain control should depend primarily on close emotional support and adequate preparation for the birth experience.

6.7.5 All medicines and drugs must be properly labeled according to state and federal law.

6.7.6 Medicines and drugs requiring refrigeration must be stored and secured in a refrigerator for that purpose.

6.7.7 Medicines and drugs shall be administered only by persons authorized and licensed to administer medicines and drugs.

6.7.8 When the facility maintains its own pharmaceutical services, it shall comply with applicable state laws and regulations.

6.8 Laboratory Service

6.8.1 Clinical pathology services shall be available as required by the needs of the patients and as determined by the facility staff.

6.8.2 The facility may either provide a clinical laboratory or make contractual arrangement with an outside laboratory.

16 Del. Admin. Code § 3365-6.0

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