16 Del. Admin. Code § 3365-5.0

Current through Register Vol. 28, No. 5, November 1, 2024

Section 3365-5.0 - Administration/Personnel

5.1 Administrator

5.1.1 There shall be a full-time facility administrator.

5.1.2 The administrator shall be responsible for implementing the policies adopted by the governing body.

5.1.3 The administrator shall have the overall authority and responsibility for the daily operation and management of the facility.

5.1.4 The administrator shall designate, in writing, a qualified person to act in her/his behalf during her/his absence.

5.1.5 The administrator shall review facility policies and procedures at least annually and report to the governing body on the review.

5.1.6 The authority, duties and responsibilities of the administrator shall be defined in writing and shall include but not be limited to:

5.1.6.1 Interpretation and execution of the policies of the facility;

5.1.6.2 Program planning, budgeting, management and evaluation;

5.1.6.3 Maintenance of the facility's compliance with licensure regulations and standards;

5.1.6.4 Preparation and submission of required reports;

5.1.6.5 Distribution of a written plan for the delegation of administrative responsibilities and functions in the absence of the director;

5.1.6.6 Documentation of complaints relating to the conduct or actions by licensed health care professionals and action taken secondary to the complaints; and

5.1.6.7 Conducting or supervising the resolution of complaints received from patients in the delivery of care or services received at the facility.

5.2 Clinical Director

5.2.1 The clinical director shall be responsible for implementing, coordinating and assuring quality of patient care services.

5.2.2 The clinical director shall:

5.2.2.1 Be currently licensed as a physician or nurse midwife; and

5.2.2.2 Have training and expertise in obstetric and newborn services to ensure adequate supervision of patient care services.

5.2.3 The authority, duties and responsibilities of the clinical director shall be defined in writing and shall include but not be limited to:

5.2.3.1 Review and update of facility policies, procedures and protocols;

5.2.3.2 Review and evaluate clinical staff privileges;

5.2.3.3 Recommend, to the governing body, names of qualified personnel to perform approved procedures and the corresponding clinical staff privileges to be granted;

5.2.3.4 Coordinate, direct and evaluate clinical operations of the facility;

5.2.3.5 Evaluate and recommend to the administrator the type and amount of equipment needed in the facility;

5.2.3.6 Ensure that qualified staff are on the premises when patients are in the facility;

5.2.3.7 Ensure clinical staff documentation is recorded immediately and reflects a description of care given;

5.2.3.8 Ensure that planned birthing center services are within the scope of privileges granted to the clinical staff;

5.2.3.9 Ensure the accuracy of public education information materials and activities in relation to pregnancy and birth, mother and infant care, and the facility; and,

5.2.3.10 Recommend to the administrator appropriate remedial action and disciplinary action, when necessary, to correct violations of clinical protocols.

5.3 Clinical Staff

5.3.1 There shall be a single organized professional staff consisting of physicians, nurse midwives or certified professional midwives and registered nurses.

5.3.2 The organized professional staff shall have the overall responsibility for the quality of all clinical care provided to patients.

5.3.3 There shall be sufficient, qualified personnel available to perform the services offered by the facility.

5.3.4 All clinical staff who perform services in the facility who are required by state law to be licensed, registered or certified shall have valid licenses, registrations or certificates.

5.3.5 A physician certified by the American Board of Obstetrics and Gynecology or who is qualified and authorized by training and experience in obstetrics and gynecology shall be immediately available by telephone twenty-four hours a day.

5.3.6 Each physician providing services for the facility must demonstrate hospital admitting privileges for patients who develop complications.

5.3.7 Each certified mid-wife (nurse or professional) providing services for the facility must provide proof of a back-up agreement with a physician who will accept consultation calls and referrals twenty-four (24) hours a day, seven (7) days a week.

5.3.7.1 The back-up physician must demonstrate hospital admitting privileges for patients who develop complications.

5.3.8 The facility shall establish a job description for each classification of position, which clearly delineates qualifications, duties, authority, and responsibilities inherent in each position.

5.3.9 A physician or certified mid-wife shall be present at each birth and until the woman and newborn are stable postpartum.

5.3.9.1 A second person in addition to the above, who is a registered nurse with adult and infant resuscitation skills, shall be present during the delivery.

5.3.10 A certified mid-wife or registered nurse with adult and infant resuscitation skills shall be present at the facility at all times when a patient is present.

5.3.11 Clinical staff shall comply with facility policies and procedures.

5.3.12 Clinical staff shall comply with applicable professional practice standards.

5.4 Written Policies

5.4.1 Policy manuals shall be prepared and followed which outline the procedures and practices of the facility.

5.4.2 There shall be written policies regarding the screening criteria, risk status criteria and procedures for identifying:

5.4.2.1 Low-risk patients who shall be eligible for birthing services offered by the birthing center, and

5.4.2.2 Individuals who shall be ineligible for birthing services at the birthing center.

5.4.3 There shall be written policies regarding:

5.4.3.1 Identification and transfer of patients who, during the course of pregnancy, are determined to be ineligible, and

5.4.3.2 Identification and transfer of patients who, during the course of labor or recovery, are determined to be ineligible for continued care in the birthing center.

5.4.4 There shall be written policies for:

5.4.4.1 Consultation, back-up services, transfer and transport of a newborn or maternal patient to a hospital;

5.4.4.2 Routine and emergency care of both the maternal and the fetus or newborn patient until completion of care by the birthing center either through completion of the care program or through transfer to another level of care;

5.4.4.3 Care following discharge for both the patient and the newborn;

5.4.4.4 The provision of education to patients, family and support persons in childbirth and newborn care;

5.4.4.5 Birth reporting requirements; and

5.4.4.6 Infection control.

5.4.5 There shall be written personnel policies, including but not limited to:

5.4.5.1 Pre-employment requirements;

5.4.5.2 Position descriptions;

5.4.5.3 Orientation of all new employees;

5.4.5.4 Inservice education;

5.4.5.5 Annual performance review and competency; and

5.4.5.6 The process of appointment to the professional staff whereby it can satisfactorily be determined that the individual is appropriately licensed and qualified for the privileges and responsibilities to be given.

5.4.6 There shall be written policies designed to enhance safety within the facility and on its premises and to minimize hazards to patients, staff and visitors including:

5.4.6.1 Rules and practices pertaining to personnel, equipment, liquids, drugs and hazards to children including but not limited to electrical outlets, unsafe toys, stairs, storage cabinets, kitchen cabinets and outdoor areas;

5.4.6.2 Reporting and investigation of accidental events and corrective action taken;

5.4.6.3 Dissemination of safety-related information to employees and users of the facility;

5.4.6.4 Syringe and needle storage, handling and disposal;

5.4.6.5 Storage and handling of drugs and biologicals;

5.4.6.6 A preventative maintenance program which is implemented to keep the entire facility and equipment in good repair and to provide for the safety, welfare and comfort of the occupants of the building(s);

5.4.6.7 Housekeeping;

5.4.6.8 Safe storage of cleaning materials and pesticides and other potentially toxic materials;

5.4.6.9 Safe storage and handling of soiled linen and clothing;

5.4.6.10 Pest control; and

5.4.6.11 Waste disposal.

5.4.7 Policies shall be reviewed and dated annually and revised as necessary.

5.4.8 Policies shall be made available to representatives of the Department upon request.

5.5 Personnel Records

5.5.1 Records of each employee/contractor shall be kept current and available upon request by authorized representatives of the Department.

5.5.2 The facility shall maintain individual personnel records which shall contain at least:

5.5.2.1 Written verification of compliance with pre-employment requirements;

5.5.2.2 Documentation of participation in a formal orientation program to the facility;

5.5.2.3 Copies of professional licenses, registrations or certifications;

5.5.2.4 Documentation of competence;

5.5.2.5 Educational preparation and work history;

5.5.2.6 Written performance reviews (annually); and

5.5.2.7 A letter of appointment specifying conditions of employment.

5.6 Employment Practices

5.6.1 Health History

5.6.1.1 All new personnel shall be required to have a physical examination prior to providing care.

5.6.1.1.1 The physical examination must have been completed within 3 months prior to initial employment.

5.6.1.1.2 A copy of the physical examination shall be maintained in individual files.

5.6.1.2 Minimum requirements for tuberculosis (TB) testing are those currently recommended by the Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services. Testing must be completed within ninety (90) calendar days prior to provision of birthing center services and annually thereafter.

5.6.1.2.1 No person found to have active TB in an infectious stage shall be permitted to give care or service to patients.

5.6.1.2.2 Any person having a positive skin test but a negative chest X-ray must complete a statement annually attesting that they have experienced no symptoms which may indicate active TB infection.

5.6.1.2.3 A report of all TB test results and all attestation statements shall be on file.

5.6.2 It is the responsibility of the birthing center to ensure that personnel are proficient to carry out the care assigned in a safe, effective and efficient manner.

5.6.3 Any individual who cannot adequately perform her/his duties or who may jeopardize the health or safety of the patients shall be relieved of his duties and removed from the facility until such time as the condition is resolved. This includes infections of a temporary nature.

16 Del. Admin. Code § 3365-5.0

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