16 Del. Admin. Code § 3355-6.0

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

Section 3355-6.0 - Administration/Personnel

6.1 Director

6.1.1 There shall be a full-time FSSC director.

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

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

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

6.1.3.2 Program planning, budgeting, management and program evaluation;

6.1.3.3 Maintenance of the FSSC's compliance with licensure regulations and standards;

6.1.3.4 Preparation and submission of required reports;

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

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

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

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

6.1.4 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 at least one year of surgical and administrative/supervisory experience;

6.2.3.2 Participate in all activities related to the services provided, including the qualifications of personnel and contractors as related to their assigned duties; and

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

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 FSSC maintains responsibility for all services provided to the patient.

6.3.2 Services provided by the FSSC 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 FSSC 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 A renewal clause or language that states the contract will be renewed annually.

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

6.4 Written policies

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

6.4.2 The FSSC shall establish written policies which include, but are not limited to:

6.4.2.1 Compliance with state licensure law;

6.4.2.2 Governing body and management;

6.4.2.3 Surgical 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 and discharge;

6.4.2.14 The handling and documentation of incidents, accidents and medical emergencies;

6.4.2.15 The procedure to be followed in the event that the FSSC is not able to provide services scheduled for any particular day or time;

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

6.4.2.17 Employment/Personnel. Such policies shall include:

6.4.2.17.1 Qualifications, responsibilities and requirements for each job classification;

6.4.2.17.2 Pre-employment requirements;

6.4.2.17.3 Position descriptions;

6.4.2.17.4 Orientation;

6.4.2.17.5 Inservice education;

6.4.2.17.6 Annual performance review and competency testing; and

6.4.2.17.7 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 The FSSC shall review its written policies at least annually, and revise them as necessary. Documentation of the annual review must be maintained by the FSSC.

6.4.4 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 FSSC 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 FSSC;

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 FSSC 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 All persons admitted to the FSSC shall be under the care of a physician.

6.7.2 One (1) or more physicians should be in attendance in the FSSC, or in the case of overnight care, immediately available via electronic communication, at all times during patient treatment and recovery and until patients are medically discharged.

6.7.3 A medical director shall be appointed and shall be responsible for the direction, provision and quality of medical care.

6.7.4 All members of the FSSC's medical staff must be appointed to their position within the FSSC by the governing body.

6.7.5 Medical staff privileges must be granted by the governing body, in writing, and must specify, in detail, the types of procedures that each physician may perform within the FSSC.

6.7.6 Medical staff privileges must be reappraised by the FSSC at least every 24 months.

6.7.7 If the FSSC assigns patient care responsibilities to licensed independent practitioners other than physicians, 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.

6.8 Nursing services

6.8.1 Nursing services must be under the direction of a clinical director.

6.8.2 There must be sufficient nursing staff with the appropriate qualifications to assure the nursing needs of all FSSC patients are met.

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

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

6.8.5 A registered nurse, qualified by education and experience in operating room nursing, shall be present as a circulating nurse in each operating room where moderate/deep/general anesthesia/sedation is administered during operative procedures.

6.8.6 Individual patient assignments on a given day must be documented clearly on an assignment sheet which must be kept on file for one (1) year from date of procedure.

16 Del. Admin. Code § 3355-6.0

25 DE Reg. 627( 12/1/2021) (final)