16 Del. Admin. Code § 3340-6.0

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

Section 3340-6.0 - Administration/Personnel

6.1 Director

6.1.1 There shall be a full-time physician serving as director who is board certified in emergency medicine.

6.1.2 The director shall have the overall authority and responsibility for the daily operation and management of the FSED.

6.1.3 The director shall be responsible for the direction, provision and quality of medical care.

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

6.1.4.1 Interpretation and execution of the policies adopted by the governing body;

6.1.4.2 Program planning, budgeting, management and program evaluation;

6.1.4.3 Maintenance of the FSED's compliance with licensure regulations and standards;

6.1.4.4 Preparation and submission of required reports;

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

6.1.4.6 Documentation of complaints relating to the conduct or actions by employees/contractors/medical staff and action taken secondary to the complaints;

6.1.4.7 Conducting or supervising the resolution of complaints received from patients regarding the delivery of care or services; and

6.1.4.8 Reviewing policies and procedures at least annually, and reporting, in writing, to the governing body on the review.

6.1.5 The director shall designate, in writing, a person who meets the director qualifications to act in the absence of the director.

6.2 Supervision of clinical services

6.2.1 The director shall appoint, in writing, a full-time employee as the clinical director.

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

6.2.3 The clinical director shall:

6.2.3.1 Be a registered nurse with evidence of substantial education, experience and competence in emergency nursing. The Certified Emergency Nurse (CEN) credential is preferred, but not required; and

6.2.3.2 Show evidence of competence in management/administration/supervision of the clinical services of the FSED; and

6.2.3.3 Provide general supervision and direction of the services offered by the FSED.

6.2.4 The director shall designate, in writing, a person who meets the clinical director qualifications to act in the absence of the clinical director.

6.3 Contract services

6.3.1 The FSED maintains responsibility for all services provided to the patient.

6.3.2 Services provided by the FSED through arrangements with a contractor agency or individual shall be set forth in a written contract which clearly specifies:

6.3.2.1 The services to be provided by the contractor;

6.3.2.2 The necessity to conform to all FSED policies;

6.3.2.3 The procedure for annual assurance of clinical competence of all individuals utilized under contract;

6.3.2.4 The procedure for supervision of services of the contracted individuals; and

6.3.2.5 The frequency of contract renewal.

6.3.3 The FSED must ensure that personnel and services contracted meet the requirements specified in these regulations for FSED personnel and services.

6.4 Written policies

6.4.1 Policy manuals which outline the procedures and practices of the FSED shall be prepared and followed.

6.4.2 The FSED shall establish written policies which include:

6.4.2.1 Compliance with state licensure law;

6.4.2.2 Governing body and management;

6.4.2.3 Emergency services;

6.4.2.4 Quality assessment and performance improvement;

6.4.2.5 Environment;

6.4.2.6 Medical staff;

6.4.2.7 Nursing services;

6.4.2.8 Medical records;

6.4.2.9 Pharmaceutical services;

6.4.2.10 Laboratory and radiologic services;

6.4.2.11 Patient rights;

6.4.2.12 Infection control;

6.4.2.13 Patient admission, assessment, discharge and transfer;

6.4.2.14 The investigation and documentation of incidents, accidents and major adverse incidents;

6.4.2.15 Reporting of all reportable communicable diseases to the Department; and

6.4.2.16 Employment/Personnel. Such policies shall include:

6.4.2.16.1 Qualifications, responsibilities and requirements for each job classification;

6.4.2.16.2 Pre-employment requirements;

6.4.2.16.3 Position descriptions;

6.4.2.16.4 Orientation;

6.4.2.16.5 In-service education;

6.4.2.16.6 Annual performance review and competency testing; and

6.4.2.16.7 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.

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

6.5 Personnel records

6.5.1 Records of each employee/contractor shall be available upon request by authorized representatives of the Department.

6.5.2 For all employees/contractors, the FSED shall maintain current individual personnel records on-site which shall contain at least:

6.5.2.1 Written verification of compliance with pre-employment requirements;

6.5.2.2 Documentation of clinical competence;

6.5.2.3 Evidence of current professional licensure, registration or certification as appropriate;

6.5.2.4 Educational preparation and work history;

6.5.2.5 Written performance evaluations conducted, at least, annually; and

6.5.2.6 A written and signed job description.

6.6 Staff development

6.6.1 All employees/contractors, including medical staff, are required to complete an orientation program.

6.6.2 An orientation/training program should be based on an instruction plan that includes learning objectives, clinical content and minimum acceptable performance standards, and shall include but not be limited to:

6.6.2.1 Organizational structure of the FSED;

6.6.2.2 Patient care policies and procedures;

6.6.2.3 Infection control;

6.6.2.4 Philosophy of patient care;

6.6.2.5 Patient rights;

6.6.2.6 Personnel and administrative policies;

6.6.2.7 Job description;

6.6.2.8 Disaster preparedness; and

6.6.2.9 Applicable state regulations governing the delivery of services.

6.6.3 Documentation of orientation must include the date and hours, content, and name and title of the person providing the orientation.

6.6.4 It is the responsibility of the FSED to ensure that employees/contractors are proficient to carry out the assigned care in a safe, effective and efficient manner. Nothing in these regulations is intended to restrict the practice of licensed independent practitioners practicing in accordance with Delaware law.

6.6.5 All newly hired employees and contractors must have a written validation of competency upon orientation, prior to providing care to patients, and annually thereafter.

6.6.6 Attendance records must be kept for all orientation and continuing education programs.

6.7 Medical Staff

6.7.1 Each physician practicing in the FSED shall be licensed to practice in this State and:

6.7.1.1 Be board-certified in emergency medicine;

6.7.1.2 Be board-eligible for certification in emergency medicine and attain certification within three years of completion of a residency program; or

6.7.1.3 Have at least three years of full-time clinical experience in emergency medicine within the past five years, be American Board of Medical Specialties or American Osteopathic Association certified in a medical specialty, and hold current certifications in advanced cardiac life support, advanced pediatric life support, and advanced trauma life support.

6.7.2 One (1) or more physicians shall be in attendance at the FSED at all times.

6.7.3 All members of the FSED medical staff must be:

6.7.3.1 Individually credentialed to ensure the individual is deemed qualified; and

6.7.3.2 Appointed to their position within the FSED by the governing body.

6.7.4 Medical staff privileges must be granted by the governing body, in writing.

6.7.5 Medical staff privileges must be reappraised by the FSED at least every 24 months.

6.7.5.1 Reappraisals must include assessment of current competence by the FSED Director.

6.7.6 Resident physicians and non-physician providers may work in the FSED as long as there are procedures in place for prompt consultation and communication with an on-site physician.

6.7.7 If the FSED assigns patient care responsibilities to resident physicians or non-physician providers, it must have:

6.7.7.1 Established credentialing and privileging procedures approved by the governing body; and

6.7.7.2 Policies and procedures, approved by the governing body, for overseeing and evaluating clinical activities.

6.7.8 The medical staff shall adopt, implement and enforce written bylaws to carry out its responsibilities. The bylaws shall:

6.7.8.1 Be approved by the governing body;

6.7.8.2 Include a statement of the duties and privileges of each category of medical staff (i.e. active, consultant);

6.7.8.3 Describe the organization of the medical staff; and

6.7.8.4 Include criteria for privileges to be granted and a procedure for applying the criteria to individuals requesting privileges.

6.8 Nursing services

6.8.1 There shall be an organized nursing services which must be under the direction of the clinical director.

6.8.2 Each registered nurse practicing in the FSED shall:

6.8.2.1 Be licensed as a registered nurse in this State;

6.8.2.2 Hold, or attain within 6 months of hire, certifications, or the equivalents as approved by the Department, in advanced cardiac life support and pediatric advanced life support; and

6.8.2.3 Hold and maintain current certification in Basic Cardiac Life Support.

6.8.3 There must be sufficient nursing staff with the appropriate qualifications to ensure the nursing needs of all FSED patients are met.

6.8.4 Patient care responsibilities must be delineated for all nursing service personnel.

6.8.5 Nursing services must be provided in accordance with recognized standards of practice.

6.9 There must be at least one physician that meets the requirements set forth in these regulations, and one registered nurse with current certifications, or equivalents as approved by the Department, in advanced cardiac life support and pediatric advanced life support in the FSED at all times.

6.10 There shall be adequate medical and nursing personnel qualified in emergency care to meet the written emergency procedures and needs anticipated by the facility.

6.11 Schedules, names, and telephone numbers of all physicians and others on emergency call duty, including alternates, shall be maintained. The facility shall retain all schedules for at least one year.

16 Del. Admin. Code § 3340-6.0

24 DE Reg. 692( 1/1/2021) (final)