16 Del. Admin. Code § 3365-3.0

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

Section 3365-3.0 - General Requirements

3.1 The birthing center shall not admit, nor continue to care for, patients whose needs cannot be met by the facility.

3.1.1 A physician or certified midwife shall make a determination of general health status and risk factors after obtaining a detailed medical history, performing a physical examination and taking into account family circumstances and other social and psychological factors.

3.1.2 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.

3.2 The birthing center shall utilize an established written risk assessment system.

3.2.1 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.

3.2.2 Patients with any minimum risk factors, including but not limited to those listed in 3.2.3, shall be referred to a physician for continuing maternity care and hospital delivery.

3.2.3 Minimum risk factors include but may not be limited to:

3.2.3.1 Patient is less than 16 years of age.

3.2.3.2 Major medical problems including but not limited to:

3.2.3.2.1 Chronic hypertension;

3.2.3.2.2 Chronic heart disease;

3.2.3.2.3 Pulmonary embolus;

3.2.3.2.4 Congenital heart defects;

3.2.3.2.5 Severe renal disease;

3.2.3.2.6 Lupus erythematosus;

3.2.3.2.7 Drug or alcohol addiction;

3.2.3.2.8 Required use of anticonvulsant drugs;

3.2.3.2.9 Bleeding disorder or hemolytic disease;

3.2.3.2.10 Paraplegia/quadriplegia;

3.2.3.2.11 Diabetes mellitus;

3.2.3.2.12 Cognitive impairment that would interfere with the ability to follow directions;

3.2.3.2.13 Morbid obesity;

3.2.3.2.14 Active genital herpes, syphilis or HIV positive;

3.2.3.2.15 The need for general or conduction anesthesia;

3.2.3.2.16 The need for a caesarian section; or

3.2.3.2.17 Serious congenital anomaly in a previous birth whose recurrence cannot be ruled out by antenatal evaluation.

3.2.3.3 Previous history of significant obstetrical complications including but not limited to:

3.2.3.3.1 Rh sensitization;

3.2.3.3.2 Previous uterine wall surgery including cesarean section;

3.2.3.3.3 Five or more term pregnancies with other risk factors;

3.2.3.3.4 Nullipara of greater than 40 years of age with other risk factors;

3.2.3.3.5 Multipara over 45 years of age with other risk factors; or

3.2.3.3.6 Previous placenta abruption.

3.2.3.4 Significant signs or symptoms of:

3.2.3.4.1 Hypertension;

3.2.3.4.2 Toxemia;

3.2.3.4.3 Polyhydramnios or oligohydramnios;

3.2.3.4.4 Abruption placenta;

3.2.3.4.5 Chorioamnionitis;

3.2.3.4.6 Malformed fetus;

3.2.3.4.7 Fetal distress;

3.2.3.4.8 Multiple gestation;

3.2.3.4.9 Intrauterine growth retardation or macrosomia;

3.2.3.4.10 Thrombophlebitis; or

3.2.3.4.11 Pyelonephritis.

3.3 All records maintained by the birthing center shall at all times be open to inspection by the authorized representatives of the Department.

3.4 No policies shall be adopted by the birthing center which are in conflict with these regulations.

3.5 The birthing center shall establish written policies regarding the rights and responsibilities of patients.

3.6 The birthing center shall establish policies and procedures that address the handling and documentation of incidents, accidents and medical emergencies.

3.7 Reports of incidents, accidents and medical emergencies shall be kept on file at the facility.

3.8 The birthing center shall establish policies which control the exposure of patients and staff to persons with communicable diseases.

3.9 The birthing center shall establish policies which require reporting of all reportable communicable diseases to the Department.

3.10 A procedure, approved by the Department and including the patients and families right to report concerns/complaints to the Department at a telephone number established for that purpose, shall be established to enable patients and their families to have their concerns addressed without fear of reprisal.

3.11 The birthing center shall advise the Department in writing within fifteen (15) calendar days following any change in the designation of the directordministrator or other administrative personnel within the facility.

3.12 The birthing center may not establish separate facilities without first contacting and receiving approval from the Department.

3.13 The birthing center may contract for services to be provided to its patients. Individuals providing services under contract must meet the same requirements as those persons employed directly by the facility.

3.14 The director/designee shall be available at all times during the operating hours of the birthing center.

3.15 The birthing center must permit photocopying of any records or other information by, or on behalf of authorized representatives of the Department, as necessary to determine or verify compliance with these regulations.

3.16 Report of Major Adverse Incidents

3.16.1 The facility must report all major adverse incidents involving a patient to the Department within forty-eight (48) hours in addition to other reporting requirements required by law.

3.16.2 A major adverse incident includes but is not limited to:

3.16.2.1 Suspected abuse, neglect, mistreatment, financial exploitation of a patient, solicitation or harassment;

3.16.2.2 An accident that causes injury to a patient; and

3.16.2.3 The unexpected death of a patient.

3.16.3 Major adverse incidents must be investigated by the facility and a report must be generated.

3.16.4 A complete report will be forwarded to the Department within thirty (30) calendar days of occurrence or of the date that the facility first became aware of the incident.

16 Del. Admin. Code § 3365-3.0

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