Ga. Comp. R. & Regs. R. 111-8-22-.10 - Staff Qualifications, Training, and Supervision and Staff Records

(1) Staff Orientation.

(a) The facility shall provide a facility orientation program for all staff, approved by the medical director, to include at least:

1. A review of the services provided by the facility;

2. A review of facility policies and procedures, including general infection control procedures and use of universal precautions;

3. The facility's emergency procedures and disaster preparedness plans;

4. The facility's continuous quality improvement program; and

5. Documentation and records requirements.

(b) The facility shall document that each staff member has attended the orientation program.

(2) Nursing Staff.

(a) Minimum Education and Experience Qualifications for Nursing Staff.

1. Any registered nurse or licensed practical nurse providing services in the facility shall have and maintain a current Georgia license to practice nursing.

2. Registered nurses in charge of the training of patients in self-care, involving either home hemodialysis or peritoneal dialysis, shall have a minimum of three months of experience working with dialysis self-care patients.

3. Prior to providing dialysis care, all nursing staff shall demonstrate satisfactory completion of either the training program or educational equivalency and the competency skills assessment checklist as required for dialysis technicians.

(b) Supervision of Nursing Staff.

1. The nurse responsible for nursing services shall ensure that the licensed practical nurses participating in the provision of appropriate nursing services are familiar with protocols established by the medical staff as necessary for patient care during dialysis treatment. At all times a registered nurse must be in the patient care area while patient care is being provided.

2. Any registered nurse or licensed practical nurse who is employed without previous experience in the dialysis process, and who has not yet successfully completed the skills competency checklist, shall be directly supervised when engaged in dialysis treatment activities with patients by a staff member who has demonstrated skills competency for dialysis treatment as required by these rules.

(c) Training of Nursing Staff.

1. When a facility hires a registered nurse who has not had previous dialysis experience, the facility shall conduct and document a training needs assessment to identify training needs specific to care for the dialysis patient, and shall document the provision of such training by an instructor meeting the qualifications for training dialysis technicians as indicated by the needs assessment, together with satisfactory completion of a skills competency checklist.

2. Licensed practical nurses providing dialysis care shall meet the same training and competency requirements, including the documentation of such training and competency, as required by these rules for dialysis technicians.

3. The facility shall require and maintain adequate documentation for all nursing staff of a minimum of twelve (12) clock hours per year of continuing education related to end stage renal disease treatment.

(d) Competency Evaluation for Nurses. The facility shall document for each licensed nurse the satisfactory completion of a skills competency checklist in dialysis treatment, signed by the registered nurse responsible for nursing services at the facility, or qualified instructor under these rules, prior to the unsupervised provision of hemodialysis or peritoneal dialysis treatment to patients and thereafter at least annually. The competency skills assessment shall reflect those patient care activities provided by the nurse, and shall include age-specific competencies when applicable.

(3) Dialysis Technicians.

(a) An individual may not function as or be represented to be a dialysis technician unless that individual has satisfied the training and competency requirements of these rules. The individual in the process of completing training as a dialysis technician shall be identified as a trainee when present in any patient area of the facility.

(b) Minimum Qualifications for Dialysis Technicians. Persons first employed by the facility as dialysis technicians after the effective date of these rules shall meet or exceed the following criteria:

1. A high school diploma or equivalent;

2. Documentation of the satisfactory completion of a training program with a curriculum equivalent to or exceeding the curriculum required by these rules for dialysis technicians; and

3. Documentation of the satisfactory completion within the past twelve months of a skills competency checklist equivalent to or exceeding the competencies required by these rules for dialysis technicians, administered at the current employment facility.

(c) Required Training for Dialysis Technicians.

1. A training program curriculum for dialysis technicians shall be approved by the medical director of the facility, and shall include minimally the following educational and clinical components, defined in written form with objectives for each component:

(i) Understanding of the individual with end stage renal disease, to include:

(I) Basic renal anatomy, physiology, and pathophysiology;

(II) The effect of renal failure on other body systems;

(III) Signs and symptoms of the uremic state;

(IV) Basic renal nutrition;

(V) Basic psychosocial aspects of end stage renal disease; and

(VI) Medications commonly administered to patients with end stage renal disease, and side effects, toxicity, and other common problems associated with medications;

(ii) Introduction to dialysis treatments and options including a history of dialysis and definitions and terminologies used;

(iii) Principles of hemodialysis to include at least:

(I) The use of osmosis and diffusion for blood cleaning;

(II) Access to the circulatory system; and

(III) Anticoagultion and the role of local anesthetics and normal saline;

(iv) Hemodialysis procedures to include at least:

(I) Using aseptic technique;

(II) Technical aspects of operation and monitoring of dialysis equipment, and of the initiation and termination of dialysis;

(III) Delivery of an adequate dialysis treatment and factors which may result in inadequate treatment;

(IV) Observation and reporting of patient reactions to treatment;

(V) Glucose monitoring, dialysis adequacy monitoring and hemoglobin/ hematocrit monitoring; and

(VI) Emergency procedures and responses such as cardiopulmonary resuscitation, air embolism management, management of hypo and hypertensive crises, response to line separation during hemodialysis, calling an ambulance, and handling patient death;

(v) Hemodialysis equipment to include at least:

(I) Theory and practice of conventional, high efficiency, and high flux dialysis;

(II) Dialysate composition, options, indications, complications, and safety;

(III) Safe equipment operation and monitoring; and

(IV) Equipment disinfection;

(vi) Water treatment to include:

(I) Standards for water treatment used for dialysis as described in the current American National Standard, Hemodialysis Systems, published by the Association for the Advancement of Medical Instrumentation (AAMI);

(II) Water treatment systems and devices;

(III) Monitoring of water; and

(IV) Risks to patients of unsafe water;

(vii) Reprocessing, if the facility practices dialyzer reuse, to include at least:

(I) Principles of reuse;

(II) Safety, quality control, universal precautions, and water treatment in reprocessing; and

(III) Standards for reprocessing of dialyzers for reuse, as described in the current American National Standard, Reuse of Hemodialyzers, published by the Association for the Advancement of Medical Instrumentation (AAMI);

(viii) Patient teaching, to include at least the role of the technician in supporting patient education goals;

(ix) Infection control during dialysis and in the dialysis environment, to include at least:

(I) Risks to patients of nosocomial infections, accidents, and errors in treatment;

(II) Sterile techniques and specimen handling;

(III) Basic bacteriology and epidemiology;

(IV) Risks to employees of blood and chemical exposure; and

(V) The importance of ongoing quality control activities in assuring safe dialysis treatments are provided to patients;

(x) The facility's grievance policies, and the handling of patient complaints.

2. If the dialysis technician is to participate in training or treatment with peritoneal dialysis patients, the following components must be included in the training curriculum in addition to those components listed above:

(i) Principles of peritoneal dialysis;

(ii) Sterile technique for peritoneal dialysis;

(iii) Peritoneal dialysis delivery systems;

(iv) Symptoms of peritonitis; and

(v) Complications of peritoneal dialysis.

3. If the dialysis technician is to cannulate the access site, the training curriculum shall include, in addition to those components listed under 111-8-22-.10(3)(c)1. above, training in accessing the circulatory system, including at least:

(i) The creation and development of a fistula, needle placement for access, and prevention of complications;

(ii) The materials used and creation of grafts, needle placement for access in a graft, and prevention of complications; and

(iii) Identification of signs and symptoms of complications when cannulating access.

4. The trainee shall independently complete a written examination at the completion of the training program, which shall encompass the content of the curriculum in subsection 1. of this section, and, as applicable, subsection 2. and/or 3. The trainee shall be required to obtain a passing score of 80% or greater on the written examination. Current certification as a dialysis technician by a nationally recognized certification organization or satisfactory evidence of having successfully passed a nationally standardized test of competency for dialysis care technicians approved by the Department may exempt an individual from the requirement of the training program and written examination, if permitted by facility policy.

5. The curriculum for the training program shall be:

(i) Reviewed at least annually by the medical director, and updated as needed by changes in the facility's equipment and/or procedures;

(ii) Administered under conditions that do not compromise the integrity of each individual assessment required for competency tests and the completion of skills checklists; and

(iii) Where the Department determines that the facility's training program does not appear to provide adequate evidence of training in accordance with these requirements as a result of the identification of rule violations associated with the quality of care being provided by dialysis technicians and/or the facility's performance falls below acceptable levels on at least three patient care quality indicators, such as mortality rate, hospitalization rate, catheter rates, fistula rates, hematocrit levels and urea reduction rates and the Department so notifies the facility, the facility will be required to utilize a nationally standardized competency test approved by the Department. The facility shall have one year from the date of the Department's notification to have all its dialysis care technicians providing care having passed an approved nationally standardized competency test for dialysis care technicians and must continue using the nationally standardized competency test for all new hires. No dialysis care technician hired after the facility has received notice of that nationally standardized competency test is being required by the Department shall be permitted to continue in employment at the facility for more than one (1) year without having satisfactorily completed a nationally standardized test of competency approved by the Department.

6. Instructors. Instructors for the training program for dialysis technicians shall have passed the training and clinic skills competency checklist for dialysis technicians. All instructors providing training for dialysis technicians two years from the effective date of these rules and thereafter, shall have passed a nationally recognized and standardized examination for the provision of dialysis care as approved by the Department.

(i) For the two years immediately following the adoption of these rules, a registered nurse or licensed practical nurse with at least twelve months of experience in hemodialysis, and at least three months experience in peritoneal dialysis, if applicable to the facility program, or an instructor qualified by education and training providing a dialysis technician training course through an accredited college or university may serve as an instructor of dialysis technicians.

(ii) Adjunct Instructors. With twelve (12) months experience in a dialysis setting, licensed dietitians, licensed social workers or qualified dialysis technicians providing training on water reuse or equipment maintenance may provide those components of the training program within their specific areas of expertise under the supervision of the instructor.

(d) Clinical Supervision of Dialysis Technicians and Trainees.

1. Trainees who are in the process of completing a dialysis technician training program shall provide patient care only as a part of the training program, and only under the immediate and direct monitoring of either:

(i) A licensed nurse meeting the qualifications of this chapter, or

(ii) An assigned preceptor, who is either a licensed practical nurse or a dialysis technician with at least one year of dialysis experience and a current satisfactory skills competency checklist as required of a dialysis technician on file at the facility.

2. The facility shall define by written policy the hours of directly monitored clinical patient care activities required for the completion of the training program for staff coming into the facility with credentials demonstrating appropriated competencies. At a minimum, facility policy must provide for 40 hours of monitored clinical patient care activities and completion of a skills checklist. For the first forty (40) hours of monitored patient care activities, this staff may not be counted in the staff:patient care ratio.

3. A licensed facility utilizing a temporary employment agency to provide patient care services must have a written agreement with the temporary agency that specifies that the staff the agency sends to provide patient care services to the facility must meet the staff qualification set forth in these rules. The facility will monitor contract performance to ensure that the agency staff providing patient care services in the facility are competent to perform the assigned patient care tasks and that the agency staff have been familiarized with the particular facility's environment and procedures for handling emergencies prior to caring for patients at the facility.

4. Dialysis technicians who have completed an acceptable training program and skills competency checklist shall be supervised by a registered nurse. A licensed registered nurse shall be immediately available in the dialysis area to monitor the care being provided by the dialysis technician to the patient.

(e) Competency Evaluation for Dialysis Technicians. In addition to the satisfactory completion of the required training program and written examination, the dialysis technician trainee, each dialysis technician newly employed, and each dialysis technician at least annually, shall be required to demonstrate satisfactory clinical patient care performance through a skills competency evaluation.

1. A licensed nurse who qualifies as an instructor in these rules shall administer to each trainee or technician an assessment of skills through a skills competency checklist which covers at least the following acts:

(i) Assembling necessary supplies for hemodialysis;

(ii) Preparing dialysate according to procedures and dialysis prescription;

(iii) Assembling and preparing the dialysis extracorporeal circuit correctly;

(iv) Securing the correct dialyzer for the specific patient;

(v) Installing and rinsing the dialyzer and all necessary tubing;

(vi) Testing monitors and alarms, conductivity, and (if applicable) presence and absence of residual sterilants;

(vii) Setting monitors and alarms according to facility and manufacturer protocols;

(viii) Obtaining predialysis vital signs, weight, and temperature according to facility protocol and informing the registered nurse of unusual findings;

(ix) Inspecting access for patency and, after cannulation is performed and heparin administered, initiating dialysis according to the patient's prescription, observing universal precautions, and reporting unusual findings to a licensed nurse;

(x) Adjusting blood flow rates according to established protocols and the patient's prescription;

(xi) Calculating and setting the dialysis machine to allow fluid removal rates according to established protocols and the patient's prescription;

(xii) Monitoring the patient and equipment during treatment, responding appropriately to patient needs and machine alarms, and reporting unusual occurrences to a licensed nurse;

(xiii) Monitoring patient blood pressure and taking appropriate actions related to blood pressure according to facility protocol;

(xiv) Documenting findings and actions according to facility protocol;

(xv) Describing indicators and appropriate response to dialysis-related emergencies such as cardiac or respiratory arrest, needle displacement, or infiltration, clotting, blood leaks, or air emboli and to nonmedical emergencies such as power outages or equipment failure;

(xvi) Discontinuing dialysis and establishing hemostatis, to include at least:

(I) Inspecting, cleaning, and dressing the access site according to facility protocol; and

(II) Identifying and reporting unusual findings to a licensed nurse.

(xvii) Obtaining and recording post-dialysis vital signs, temperature, and weight and reporting unusual findings to a licensed nurse;

(xviii) Discarding supplies and sanitizing equipment and treatment chair according to facility protocol;

(xix) Communicating the patient's emotional, medical, psychological, and nutritional concerns to a licensed nurse;

(xx) Maintaining professional conduct, good communication skills, and attention to privacy and confidentiality during the care of the patient;

(xxi) For the dialysis technician trainee who will be assisting with training or treatment of peritoneal dialysis patients:

(I) Assisting patients in ordering supplies for dialysis;

(II) Making a dialysate exchange (draining and refilling the peritoneal space with dialysate) to include continuous ambulatory peritoneal dialysis exchange procedures and initiation or discontinuation of continuous cycling peritoneal dialysis;

(III) Observing peritoneal effluent and identifying significant factors;

(IV) Collecting dialysate specimen;

(V) Performing a transfer tubing change; and

(VI) Setting up and operating continuous cycling peritoneal dialysis equipment.

(xxii) For the dialysis technician trainee who will be cannulating dialysis access, the performance of cannulation, to include:

(I) Inspecting the site for access;

(II) Preparing the skin;

(III) Using aseptic technique;

(IV) Placing and securing needles correctly;

(V) Establishing blood access;

(VI) Replacing needles; and

(VII) Recognizing problems and the need to call for assistance; and

(xxiii) For the licensed practical nurse functioning as a dialysis technician, the skills competency checklist shall include, in addition to the above, the protocols for administering medications and intravenous fluids, including but not limited to normal saline, heparin and subcutaneous lidocaine, during the dialysis treatment.

2. For any items failed during the administration of the skills competency checklist, the facility shall document additional training for the trainee or technician in the area(s) of failure, and the trainee or technician shall not be permitted to provide patient care without direct supervision until all checklist items have been demonstrated satisfactorily.

(f) Verification and Demonstration of Completion of the Training Program and Competency Assessment for Dialysis Technicians. When a trainee completes a dialysis technician training program at the facility, the facility shall issue and provide to the dialysis technician a document verifying completion of the training requirements under this chapter. This document may be accepted as proof of completion of training by another facility that later employs the dialysis technician, provided that the dialysis technician is able to satisfactorily complete a skills competency checklist administered by the new place of employment.

(g) Dialysis Acts Permitted for Dialysis Technicians to Perform. A dialysis technician who has successfully completed the training program outlined herein and the skills competency checklist may perform the following actions under the supervision of a licensed registered nurse:

1. Initiate routine dialysis treatments for those patients whom the technicians are not prohibited from dialyzing as outlined in section (h) below.

2. Administer normal saline via the extracorporeal circuit during the initiation and discontinuation of the dialysis treatment and during dialysis treatment according to specified written protocols established by the medical director. At the time that the technician administers normal saline during the course of the dialysis treatment, the technician shall immediately notify the nurse responsible for that patient.

3. Monitor patients during their dialysis treatment and make adjustments in rate of treatment in accordance with established protocols and instructions.

4. Discontinue routine dialysis treatment and establish hemostasis for those patients whom the technician is not prohibited from dialyzing as outlined in section (h) below.

(h) Dialysis Acts Prohibited for the Dialysis Technician. A dialysis technician who is not a licensed practical nurse shall not:

1. Initiate or discontinue hemodialysis via a central catheter, manipulate a central catheter, or change dressings for a central catheter;

2. Administer controlled substances or dangerous drugs to patients at any time, including those medication which may be required during routine dialysis treatment, except for normal saline as provided in paragraph (g)2. above.

3. Administer blood or blood products;

4. Perform non-access site arterial puncture;

5. Accept physician orders; or

6. Provide hemodialysis treatments to pediatric patients under fourteen (14) years of age or under 35 kilograms weight.

(4) Reuse Technicians.

(a) Minimum Qualifications for Reuse Technicians. Persons first hired after the effective date of these rules to process kidney dialyzers for reuse at the facility shall meet or exceed the following criteria:

1. A high school diploma or equivalency,

2. Documentation of the satisfactory completion of a training program with a curriculum equivalent to or exceeding the curriculum required by these rules for reuse technicians, and

3. Documentation of the satisfactory completion within the past twelve months of a skills competency checklist equivalent to or exceeding the competencies required by these rules for reuse technicians, administered at the facility where currently employed.

(b) Required Training for Reuse Technicians.

1. A training program curriculum for reuse technicians shall be approved by the medical director of the facility, and shall include minimally the following educational and technical components, defined in written form, with objectives for each component which comply with the American National Standard for Reuse of Hemodialyzers, published by the Association for the Advancement of Medical Instrumentation (AAMI) and herein incorporated by reference:

(i) The basic principles of hemodialysis, emphasizing the role of the dialyzer;

(ii) The rationale for and importance of the use of treated water in dialysis and dialyzer processing, including the risks of using untreated water;

(iii) The facility's protocols for the reprocessing dialyzers and the rationale for each step of the procedure;

(iv) The operation and maintenance of the equipment used by the facility in the reprocessing program;

(v) Infection control procedures; and the importance of infection control in the handling of dialyzers and reprocessing equipment and materials;

(vi) The risks of cross-contamination, and the methods to prevent it;

(vii) The disinfection procedures, including safe handling of disinfectants, cleaning spills and disposing of toxic substances, the importance of protective equipment and ventilation in the reprocessing area, and the procedures for testing for residual disinfectant in the dialyzer;

(viii) Documentation procedures and procedures for labeling dialyzers during and after reprocessing; and

(ix) Criterion for determining when a dialyzer should not be reused, and proper disposal of used dialyzers.

2. Instructor. An instructor for a reuse technician training program shall be a licensed nurse or trained reuse technician who has successfully completed the skills competency checklist for reuse technicians within the past year.

3. Prior to completion of the training program and satisfactory demonstration of competency, the reuse technician trainee or newly employed reuse technician shall not engage in any part of dialyzer reprocessing except as a part of the training program and under the direct supervision of an instructor as defined in 111-8-22-.10(4)(b)2.

(c) Competency Evaluation for the Reuse Technician. The reuse technician trainee, any newly employed reuse technician, and each reuse technician at least annually, shall be required to demonstrate satisfactory performance of reprocessing tasks through a skills competency evaluation administered by a qualified instructor as defined in 111-8-22-.10(4)(b)2.

1. The competency skills checklist for reuse technicians shall include at least the following:

(i) Performance of all steps of the facility's protocols for reprocessing dialyzers, including receiving and transporting, rinsing and cleaning, disinfecting, storage, and setup for reuse, and observance of required procedures to control risk of infection and crosscontamination.

(ii) Monitoring and documentation of air and water quality;

(iii) Monitoring and documentation of equipment function;

(iv) Handling of toxic substances and use of protective equipment and clothing, including management of spills;

(v) Labeling of dilaizyers; and

(vi) Documentation of reprocessing for each dialyzer, and completion of required logs and forms.

2. For any items failed during the administration of the skills competency checklist, the facility shall document additional training for the trainee or technician in the area(s) of failure, and the trainee or technician shall not be permitted to reprocess dialyzers without direct supervision until all checklist items have been demonstrated satisfactorily.

(d) Verification and Documentation of Completion of the Training Program and Competency Evaluation for Reuse Technicians. When a trainee completes a reuse technician training program at the facility, the facility medical director shall issue and provide to the reuse technician a document verifying completion of the training requirements under this chapter. This document may be accepted as documentation of completion of training by another facility that later employs the reuse technician, provided that the reuse technician is able to satisfactorily complete a skills competency checklist administered at the new place of employment.

(5) Water Treatment System Technician.

(a) Minimum Qualifications for Water Treatment Systems Technicians. Individuals first hired after the effective date of these rules who are assigned responsibility for the operation and monitoring of the water treatment system shall meet or exceed the following criteria:

1. A high school diploma or equivalency;

2. Documentation of completion of an on-site training program in the principles and fundamentals of water treatment and the operation and maintenance of the equipment currently used by the facility or a training program which covered the same material as provided in the on-site program prior to employment. An on-site training program, if provided, shall be approved by the medical director, and shall include the current standards and procedures for water treatment recommended by the Association for the Advancement of Medical Instrumentation (AAMI), under the title "Hemodialysis Systems", herein incorporated by reference.

3. Demonstration of an understanding of the risks of patients exposed to water which has not been treated to remove contaminants and impurities, and documentation of satisfactory completion of a skills competency checklist at least annually to include at least the following:

(i) Basic operation and use of the facility's water treatment system, according to the manufacturer's protocols, at a minimum, from the water source through the water delivery system;

(ii) Monitoring and testing for water quality and treatment system performance, and documentation of such monitoring, as required by facility protocol;

(iii) Adherence to cleaning and disinfection schedules and procedures for the water treatment equipment;

(iv) Calibration of measurement and monitoring instruments;

(v) Troubleshooting for equipment malfunctions; and

(vi) Procedures to be followed if abnormal findings are discovered during water quality monitoring.

(b) All water treatment technicians, regardless of the date of hire must successfully complete a skills competency checklist annually for all water treatment procedures which meets or exceeds the skills competency checklist for new trainees.

(6) Equipment Technicians. An individual first hired after the effective date of these rules who functions as an equipment technician shall have at least the following minimum qualifications:

(a) High school diploma or equivalency;

(b) Completion of a training program approved by the medical director of the facility, which includes at least an overview of mechanical and equipment systems at the facility, electrical safety (including lockout) and safety requirements of dialysate delivery systems, standards and protocols for monitoring water bacteriology, both in dialysate and water used for reprocessing;

(c) Prior to being assigned responsibility for performing any equipment-related maintenance and repairs, the facility must ensure that the technician has completed training in machine maintenance and repairs for the equipment used at the facility for dialysis, reprocessing, and water treatment for which the technician may be responsible for, as provided by the equipment manufacturer(s) or other qualified staff certified by the equipment manufacturer and must complete satisfactorily an appropriate skills competency checklist administered by staff qualified to judge the required job competencies.

(d) All equipment technicians, whether hired before or after the effective date of these rules, must satisfactorily complete at least annually a skills competency checklist covering all assigned duties administered by staff qualified to judge the required job competencies.

(7) Dietitian. Any dietitian employed by the facility shall hold a current license in the state of Georgia to practice as a dietitian.

(8) Social Worker. The social worker employed by the facility shall hold a current license in the state of Georgia as either a Master's Social Worker or a Licensed Clinical Social Worker.

(9) Continuing Education. Facility staff providing patient care shall attend a minimum of twelve clock hours of continuing education activities related to end stage renal disease and treatment within twelve months of the effective date of these rules and annually thereafter. Continuing education activities may consist of, but are not limited to, seminars, lectures, and educational workshops or one-on-one training. Continuing education provided at the facility, including technician training programs, shall be accepted toward satisfaction of this requirement. The facility orientation program shall not be accepted for satisfaction of this requirement. Documentation of attendance at continuing education activities shall be kept in the personnel file for each staff member.

(10) Staff Records.

(a) The facility shall compile and maintain a personnel record for each staff member which include documentation of at least:

1. The staff member's employment history;

2. The staff member's job description;

3. The results of annual competency evaluations and job performance evaluations; and

4. Verification of the current status of any professional licenses or certifications, as applicable to the staff member's job functions.

(b) The facility shall maintain for each staff member a record of the evaluation(s) of the staff member's health status.

Notes

Ga. Comp. R. & Regs. R. 111-8-22-.10

O.C.G.A. §§ 31-44-3, 31-44-8 and 31-44-9.

Original Rule entitled "Quality Qualifications, Training and Supervision and Staff Records" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.