16 Del. Admin. Code § 3330-5.0

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

Section 3330-5.0 - Administration/Personnel

5.1 All dialysis center staff (whether employees or contractors) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients.

5.2 The medical director must:

5.2.1 Be a physician;

5.2.2 Be board-certified in internal medicine, pediatrics, nephrology or pediatric nephrology by a professional board;

5.2.3 Have completed a board-approved training program in nephrology; and

5.2.4 Have at least 12-months of experience providing care to patients receiving dialysis.

5.3 The medical director shall have the overall authority and responsibility for the daily operation and management of the dialysis center.

5.4 The medical director shall be accountable to the governing body for the quality of medical care provided to patients.

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

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

5.6.1 Program planning, budgeting, management and program evaluation;

5.6.2 Development and approval of the policies and procedures manual;

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

5.6.4 Staff education, training and performance;

5.6.5 Ensuring all individuals, including attending physicians and non-physician providers, providing patient care adhere to all policies and procedures pertaining to patient admissions/discharge/transfers, patient care, infection control and safety;

5.6.6 Maintenance of the dialysis center's compliance with federal and state licensure regulations and standards;

5.6.7 An ongoing QAPI program;

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

5.6.9 Conducting or supervising the resolution of complaints received from patients/patient representatives regarding the delivery of care or services.

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

5.8 The dialysis center shall advise the Department in writing within 15 calendar days following any change in the designation of the medical director.

5.9 Supervision of clinical services

5.9.1 The governing body shall appoint, in writing, a full-time employee of the facility as the nurse manager.

5.9.2 The nurse manager shall be responsible for implementing, coordinating and assuring quality of patient care services at only one (1) dialysis center.

5.9.3 The nurse manager shall:

5.9.3.1 Be a registered nurse with at least:

5.9.3.1.1 One (1) year of full-time experience in clinical nursing;

5.9.3.1.2 Six (6) months of experience providing maintenance dialysis; and

5.9.3.1.3 Six (6) months experience in maintenance dialysis supervision/administration.

5.9.3.2 Provide general supervision and direction of the services offered by the dialysis center.

5.9.4 The medical director shall designate, in writing, a person who meets the nurse manager qualifications to act in the absence of the nurse manager.

5.9.5 The dialysis center shall advise the Department in writing within 15 calendar days following any change in the designation of the nurse manager.

5.10 Contract services

5.10.1 The dialysis center maintains responsibility for all services provided to the patient.

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

5.10.2.1 The services to be provided by the contractor;

5.10.2.2 The necessity to conform to all dialysis center policies;

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

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

5.10.2.5 The frequency for contract renewal.

5.10.3 The dialysis center must ensure that personnel and services contracted meet the requirements specified in these regulations for dialysis center personnel and services.

5.11 Medical Staff

5.11.1 Members of the medical staff may include physicians and non-physician practitioners with training or demonstrated experience in the care of patients with end stage renal disease.

5.11.2 All members of the dialysis center medical staff must be:

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

5.11.2.2 Appointed to their position within the dialysis center by the governing body.

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

5.11.4 Medical staff privileges must be reappraised by the dialysis center at least every 24 months.

5.11.4.1 Reappraisals must include assessment of current competence by the dialysis center medical director.

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

5.11.5.1 Be approved by the governing body;

5.11.5.2 Include a statement of the duties and privileges of each category of medical staff;

5.11.5.3 Describe the organization of the medical staff; and

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

5.12 Nursing services

5.12.1 There shall be an organized nursing services which must be under the direction of the nurse manager.

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

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

5.12.4 Charge nurse

5.12.4.1 Each charge nurse must:

5.12.4.1.1 Be a registered nurse; and

5.12.4.1.2 Have at least twelve (12) months full-time nursing experience; and

5.12.4.1.3 Have at least six (6) months full-time experience, within the last twenty-four (24) months, providing nursing care to patients on maintenance dialysis.

5.12.4.2 There must be at least one (1) charge nurse present and designated at all times during the operating hours of the dialysis center.

5.12.4.3 The charge nurse responsibilities include, but are not limited to:

5.12.4.3.1 Making daily patient care assignments based on individual patient needs;

5.12.4.3.2 Providing immediate supervision of direct patient care;

5.12.4.3.3 Patient assessment when indicated; and

5.12.4.3.4 Communicating with other members of the healthcare team.

5.12.5 Staff nurse

5.12.5.1 There must be a registered nurse present and immediately available in the facility at all times in-center dialysis patients are being treated.

5.12.6 Self-care and home dialysis training and support nurse

5.12.6.1 Each nurse responsible for self-care and/or home training and support must:

5.12.6.1.1 Be a registered nurse; and

5.12.6.1.2 Have at least twelve (12) months full-time nursing experience; and

5.12.6.1.3 Have at least three (3) months full-time experience, within the last twenty-four (24) months, in each specific modality for which the nurse will provide training.

5.13 Dietitian

5.13.1 The dialysis center must have a dietitian:

5.13.1.1 Registered with the Commission on Dietetic Registration; and

5.13.1.2 With a minimum of one (1) year professional work experience in clinical nutrition as a registered dietitian.

5.13.2 One full-time equivalent of dietitian time shall be available for up to 100 patients, with the maximum patient load per full-time equivalent of dietitian time being 125 patients for all modalities.

5.14 Social Worker

5.14.1 The dialysis center must have a social worker with a master's degree in social work with a specialization in clinical practice from a school of social work accredited by the Council on Social Work Education.

5.14.2 Each facility shall employ or contract with a social worker(s) to meet the psychosocial needs of the patients.

5.14.2.1 One (1) full-time equivalent qualified social worker time shall be available for up to 100 patients.

5.14.2.2 If the patient load exceeds 100 patients, personnel shall be assigned to assist a social worker(s) with ancillary tasks (e.g., assistance with financial services, transportation, administrative, clerical, etc.). The maximum patient load, including all modalities, per full-time equivalent qualified social worker, with assigned personnel assistance, is 125 patients.

5.15 Patient Care Technicians

5.15.1 Patient care technicians must:

5.15.1.1 Have a high school diploma or the equivalent;

5.15.1.2 Complete a training program which includes the following subjects:

5.15.1.2.1 The principles of dialysis;

5.15.1.2.2 Care of patients with end stage renal disease;

5.15.1.2.3 Communication and interpersonal skills with end stage renal disease, including:

5.15.1.2.3.1 Patient sensitivity training; and

5.15.1.2.3.2 Care of difficult patients.

5.15.1.2.4 Dialysis procedures and documentation, including:

5.15.1.2.4.1 Initiation of dialysis;

5.15.1.2.4.2 Proper cannulation techniques;

5.15.1.2.4.3 Monitoring during the dialysis treatment;

5.15.1.2.4.4 Termination of dialysis.

5.15.1.2.5 Possible complications of dialysis;

5.15.1.2.6 Water treatment and dialysate preparation;

5.15.1.2.7 Infection control and prevention; and

5.15.1.2.8 Safety.

5.15.1.3 Demonstrate competency in the knowledge and skills of each component of the training program before independently providing patient care; and

5.15.1.3.1 Until the patient care technician has demonstrated competency in each component of the training program, he/she may only provide patient care as part of the training program under the direct supervision of the assigned preceptor.

5.15.1.4 Be certified by a state or national commercially available certification program within 18 months of the hire.

5.16 Water Treatment System Technicians

5.16.1 Prior to performing water treatment task independently, the staff member must complete a training program approved by the medical director and governing body.

5.17 Personnel records

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

5.17.2 The dialysis center shall maintain current individual personnel records for each employee/contractor on-site which shall at a minimum include:

5.17.2.1 Written verification of compliance with pre-employment requirements;

5.17.2.2 Documentation of clinical competence;

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

5.17.2.4 Educational preparation and work history;

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

5.17.2.6 A written and signed job description.

5.18 Staff development

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

5.18.2 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:

5.18.2.1 Organizational structure of the dialysis center;

5.18.2.2 Patient care policies and procedures;

5.18.2.3 Infection control;

5.18.2.4 Philosophy of patient care;

5.18.2.5 Patient rights;

5.18.2.6 Personnel and administrative policies;

5.18.2.7 Job description;

5.18.2.8 Emergency preparedness; and

5.18.2.9 Applicable state regulations governing the delivery of services.

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

5.18.4 It is the responsibility of the dialysis center to ensure that employees/contractors are proficient to carry out the assigned care in a safe, effective and efficient manner.

5.18.5 Nothing in these regulations is intended to restrict the practice of licensed independent practitioners practicing in accordance with Delaware law.

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

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

16 Del. Admin. Code § 3330-5.0

22 DE Reg. 853( 4/1/2019) (final)