PROPOSED RULES
(Health Care Assistants)
Original Notice.
Preproposal statement of inquiry was filed as WSR 01-14-043.
Title of Rule: WAC 246-826-100, 246-826-300, 246-826-301, 246-826-302 and 246-826-303, certification of hemodialysis technicians.
Purpose: WAC 246-826-100 is being amended to include a seventh category of health care assistants, category G, to perform hemodialysis. The proposed rules will establish definitions, health care assistants, category G, minimum requirements to perform end-stage renal dialysis, core competencies and minimum training standards for the certification of hemodialysis technicians.
Other Identifying Information: The proposal implements the provisions of 2001 legislation (chapter 22, Laws of 2001).
Statutory Authority for Adoption: RCW 18.135.030 and 18.135.020.
Statute Being Implemented: Chapter 22, Laws of 2001.
Summary: The proposed rules define the health care assistants, (category G), minimum requirements to perform end-stage renal dialysis, core competencies and minimum training standards.
Reasons Supporting Proposal: The statute requires persons trained by a federally approved end-stage renal disease facility who perform end-stage renal dialysis to obtain certification as a health care assistant.
Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Tracy Hansen, 1300 S.E. Quince Street, Olympia, WA 98504, (360) 236-4940.
Name of Proponent: Department of Health, governmental.
Agency Comments or Recommendations, if any, as to Statutory Language, Implementation, Enforcement, and Fiscal Matters: Health professions must be self-supportive.
Rule is not necessitated by federal law, federal or state court decision.
Explanation of Rule, its Purpose, and Anticipated Effects: The purpose of the rules is to amend WAC 246-826-100 to include a seventh category of health care assistants, category G, to perform hemodialysis. The proposal establishes definitions, health care assistants, category G, minimum requirements to perform end-stage renal dialysis, core competencies and minimum training standards for the certification of hemodialysis technicians. The rules will require and ensure certified health care assistants, category G, meet the same core competencies and minimum training standards for mandatory training programs to be utilized by renal dialysis facilities for training hemodialysis technicians as health care assistants.
Proposal Changes the Following Existing Rules: WAC 246-826-100 is being amended to include a seventh category of health care assistants, category G, to perform hemodialysis.
A small business economic impact statement has been prepared under chapter 19.85 RCW.
II. What industries are affected? The proposed regulations affect general medical and surgical hospitals and renal dialysis facilities that provide training for hemodialysis technicians as health care assistants in both didactic and supervised clinical instruction.
| SIC | DESCRIPTION | TOTAL UNITS | TOTAL EMP | Average employment | ||||
| Smallest 90% | Largest 10% | |||||||
| 8062 | General medical & surgical hospital | 146 | 78,593 | 11.07 | 2,027.71 | |||
| 8092 | Kidney dialysis centers | 17 | 1,303 | 15.50 | 31.50 | |||
A. Did you use a survey to estimate costs? Yes. The Department of Health (DOH) requested assistance from both small and large firms in determining the costs associated with the businesses.
B. Did you use a committee to estimate costs? Yes. A member of the committee assisted in obtaining cost information from the large firms.
C. What costs of this rule are.
There are potential costs associated with the health care facility and/or health care practitioner administrative and labor costs. There may be an increase of cost for replacing individuals in a training program. There could be a reduction in cost for those individuals who have completed their training program, become certified as a health care assistant, category G, and are moving from health care facility to health care facility. There would be less of a cost associated with retaining individuals.
Large businesses may train 110 - 116 hemodialysis technician trainees per year with low turnover. Labor costs are as follows:
| Nurse - | $30 per hour x 112 hours | = | $3,360 |
| +Preceptor - | $23 per hour x 168 hours | = | $3,864 |
| +Trainee - | $12.32 per hour x 180 hours | = | $3,450 |
| = | $10,674 | ||
| Average employment of large businesses | ÷ | 2,027 | |
| Total: | = | 5.26 | |
| Nurse - | $22 per hour x 112 hours | = | $2,464 |
| +Preceptor - | $23 per hour x 168 hours | = | $3,864 |
| +Trainee - | $10.80 per hour x 180 hours | = | $3,240 |
| = | $9,352 | ||
| Average employment of small businesses | ÷ | 11 | |
| Total: | = | 8.50 | |
| Large Business | Small Business | |
| Approximate cost per employee | $5 | $850 |
In developing core competencies, DOH provided a Hemodialysis Technicians Core Competencies Questionnaire Survey to the Hemodialysis Technicians Task Force and members of the audience during the August 24, 2001, task force meeting. By identifying the tasks frequently performed, stakeholders could identify those tasks with the greatest impact on patients.
Stakeholders were concerned that DOH should:
1. Not require beyond an entry-level hemodialysis technician.
2. Not require those tasks that will create problems due to the hemodialysis technician's practice and variability between renal dialysis centers. Example, not all facilities allow technicians to work with catheters.
3. Not change items related to job function and shift worked. Example, hemodialysis technicians who are on the evening shift so the day shift staff may not be trained to do that function initially may do the disinfecting of the equipment.
A survey assisted DOH in recognizing only core competencies at an entry-level would be sufficient for certification of hemodialysis.
The following alternative list of core competencies proved too burdensome beyond entry-level training in both didactic and supervised clinical instruction. DOH recognized the following functions go well beyond entry-level core competencies and were eliminated from the proposed draft rules:
(1) Patient Care
Management of Treatment:
- Obtain (spin) serum specimens.
- Perform hematocrit test and quality assurance.
- Prepare specimens for transportation to laboratory for analysis.
Intervention:
- Initiate appropriate action regarding symptoms and/or complications occurring with the administration of medications and dialysis treatments (e.g., antihypertensives, erythropoietin, iron dextran).
- Initiate appropriate action regarding problems of heparinization in hemodialysis (e.g., coagulation, hemorrhage, hemostasis).
- Initiate appropriate action regarding access complication in-patient (e.g., clotting, injection, recirculation).
- Initiate appropriate action regarding blood leaks during dialysis.
- Perform hemastix safety test.
Evaluation:
- Evaluate symptoms and/or complications occurring during dialysis.
- Evaluate symptoms and/or complications due to operator or equipment error.
- Evaluate symptoms and/or complications associated with the administration of medications and dialysis treatments (e.g., antihypertensives, erythropoietin, iron dextran).
- Evaluate problems regarding heparinization in hemodialysis (e.g., coagulation, hemorrhage, hemostasis).
- Evaluate access complications to patient (e.g., clotting, infection, recirculation).
- Evaluate blood leaks during dialysis.
(2) Machine Technology
Maintenance of Systems:
- Develop preventative maintenance schedules for all dialysis equipment.
- Document all dialysis equipment repair work performed.
- Maintain record of all machine maintenance performed.
- Maintain emergency equipment in proper working order for immediate use.
- Maintain/verify the calibration of ancillary equipment used to maintain medical devices.
- Maintain/calibrate dialysis machine.
- Order supplies and equipment for dialysis unit.
- Perform troubleshooting and repair of unit or home equipment according to manufacturer's recommendations, and OSHA, HCFA requirements.
- Perform preventative maintenance to dialysis and ancillary equipment following manufacturer's recommendations, and OSHA, HCFA, and AAMI requirements.
- Perform repairs to dialysis and ancillary equipment following manufacturer's recommendations and OSHA, FCFC, and AMMI requirements.
- Perform electrical leakage tests on all dialysis equipment.
- Verify blood and dialysate flow rates.
Machine Set-up:
- Assemble dialysis equipment for operation.
- Assemble auxiliary equipment (e.g., oxygen therapy).
- Install dialysis equipment in dialysis unit.
- Perform residual chemical checks.
- Perform required safety checks on dialysis equipment.
- Perform safety checks.
- Prepare bicarbonate solution.
- Prepare dialysis machine for operation.
- Prime dialysis machines.
- Rinse dialyzer of disinfectant/germicide.
Machine Operation/Evaluation:
- Monitor usage of equipment and supplies.
- Maintain equipment maintenance records for compliance with regulatory and standard setting organizations (e.g., OSHA, HCFA, JCAHO, CDC, AMMI, FDA).
- Participate in the development of equipment maintenance procedures and schedules.
(3) Water Treatment
Components/Design of Systems:
- Recognize the action of micron filtration, multimedial filtration (e.g., sand filter), submicron filtration, and ultrafiltration.
- Recognize the action of carbon absorption.
- Recognize the action of water softening.
- Recognize the action of reverse osmosis.
- Recognize the action of deionization.
- Recognize the process of ultraviolet light exposure.
Maintenance of Systems:
- Clean and disinfect water treatment equipment.
- Maintain in proper working order, all treatment components.
- Perform water treatment system checks.
Monitoring/Evaluating Systems:
- Analyze/examine water for use in dialysis.
- Collect water and dialysate specimens for cultures and chemical analysis per AAMI standards.
- Evaluate quality control of reprocessing equipment per AAMI standards.
- Monitor safety tests.
- Maintain water treatment systems records for compliance with regulatory and standard setting organizations (e.g., OSHA, HCFA, JCAHO, CDC, AMMI, FDA).
- Review (annually AAMI recommended practices for water treatment).
(4) Dialyzer Reprocessing
Procedures:
- Document dialyzer reprocessing in accordance with regulatory agencies, AAMI standards, and manufacturer's recommendations.
- Ensure proper labeling according to facility protocol.
- Maintain reprocessing records.
- Prepare dialyzer for reprocessing.
- Reprocess dialyzer per facility protocol.
Testing/Validation/Evaluation:
- Perform dialyzer reuse tests.
(5) Education/Personal Development
Personal/Professional Development:
- Explain the use of medications and treatments to patient.
- Maintain a clean and safe patient environment (e.g., infection control).
- Perform on-site clinical and technical instrumentation in-service.
- Recognize clinical manifestations of electrolyte imbalances.
- Recognize problems with decreased efficiency of dialyzer.
- Review relevant current professional literature.
- Train (precept) new technologists.
Quality Related Issues:
- Document incidents appropriately.
- Maintain appropriate documentation (data) regarding quality monitoring and treatment.
- Maintain an inventory of all chemical and equipment supplies.
- Maintain proper storage of medications to ensure quality.
- Maintain proper storage of equipment and materials.
VI. Any other mitigation techniques? There were no other
mitigation techniques used.
VII. How will you involve small business in the rule making? During the course of rules development, DOH maintained open communication with stakeholders, such as: Hemodialysis technicians task force members, medical doctors, registered nurses, hemodialysis technicians, Washington state kidney/renal dialysis centers, educators, various related associations, the general public, and individuals credentialed under chapter 18.135 RCW. These people work in various work settings and geographic areas.
During the Hemodialysis Technicians Task Force meeting on August 24, 2001, task force members and stakeholders present at the meeting were provided with a Hemodialysis Technicians Core Competencies Questionnaire and rating scale. The purpose of the rating process was to identify tasks that are most important to include in the rules. By identifying the tasks frequently performed, stakeholders could identify those tasks with the greatest impact on patients. Program staff was also interested to know what tasks should be learned prior to credentialing and after credentialing.
Fifteen people participated in the survey. All attendees of the meeting participated in the discussion of the survey and provided recommendation of core competencies. Program staff received thirteen surveys. Program staff conducted an analysis of the survey and incorporated the most important tasks into a core competency rule.
The Department of Health received letters from ten stakeholders with comments/recommendations to the proposed draft rules. Stakeholders are in support of establishing rules that relate to entry-level hemodialysis technicians and for the rules to not go beyond entry-level. Stakeholder comments regarding clarification of specific sections to the rules and establishing rules for entry-level hemodialysis technicians were incorporated.
This collaborative effort has produced rules for health care facilities and health care practitioners for their entry-level hemodialysis technicians to obtain training in both didactic and supervised clinical instruction. The training program shall extend over a period of time sufficient to provide essential, sequenced learning experiences, which enable the trainee to develop competence and shall show evidence of an organized pattern of instruction consistent with principles of learning and sound educational practices. The rules establish training standards on the health care facilities and health care practitioners without restricting or limiting the applicant's ability to obtain certification as a health care assistant, category G.
A copy of the statement may be obtained by writing to Tracy Hansen, Program Manager, Health Care Assistants Program, P.O. Box 47869, Olympia, WA 98504-7869, phone (360) 236-4940, fax (360) 664-9484.
RCW 34.05.328 applies to this rule adoption. The rule is significant under RCW 34.05.238 because it requires persons trained by a federally approved end-stage renal disease facility who perform end-stage renal dialysis to obtain certification as a health care assistant.
Hearing Location: Department of Health, Conference Center, 1101 South Eastside Street, Olympia, WA 98504, on December 28, 2001, at 9:00 a.m.
Assistance for Persons with Disabilities: Contact Tracy Hansen by December 21, 2001, TDD (800) 833-6388, or (360) 236-4940.
Submit Written Comments to: Tracy Hansen, Program Manager, Health Care Assistants Program, P.O. Box 47869, Olympia, WA 98504-7869, fax (360) 664-9484, by December 14, 2001.
Date of Intended Adoption: December 28, 2001.
Mary C. Selecky
Secretary
OTS-5208.2
AMENDATORY SECTION(Amending Order 121, filed 12/27/90, effective
1/31/91)
WAC 246-826-100
Health care assistant classification.
Effective ((September 1, 1988)) December 2001, there ((shall be
six)) are seven categories of health care assistants:
(1) Category A assistants may perform venous and capillary invasive procedures for blood withdrawal.
(2) Category B assistants may perform arterial invasive procedures for blood withdrawal.
(3) Category C assistants may perform intradermal, subcutaneous and intramuscular injections for diagnostic agents and administer skin tests.
(4) Category D assistants may perform intravenous injections for diagnostic agents.
(5) Category E assistants may perform intradermal, subcutaneous and intramuscular injections for therapeutic agents and administer skin tests.
(6) Category F assistants may perform intravenous injections for therapeutic agents.
(7) Category G assistants may perform hemodialysis.
[Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-826-100, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 18.135.030. 87-23-022 (Order PM 689), § 308-175-075, filed 11/12/87.]
(1) "Hemodialysis technician" means a person certified as a health care assistant, category G, by the department of health, who is authorized under chapter 18.135 RCW and these rules to assist with the direct care of patients undergoing hemodialysis and to perform certain invasive procedures under proper delegation and supervision by health care practitioners.
(2) "Competency" means the demonstration of knowledge in a specific area and the ability to perform specific skills and tasks in a safe, efficient manner.
(3) "Hemodialysis" means a process by which dissolved substances are removed from a patient's body by diffusion from one fluid compartment to another across a semipermeable membrane.
(4) "Dialysis facility or center" means a place awarded conditional or unconditional status by the center for Medicaid/Medicare services to provide dialysis services.
(5) "Direct supervision" means the licensed health care practitioner, as required by or authorized by RCW 18.135.020, is physically present and accessible in the immediate patient care area and available to intervene, when necessary.
(6) "Preceptor" means the licensed health care practitioner, as required by or authorized by RCW 18.135.020, who supervises, trains, and/or observes students providing direct patient care in a dialysis facility or center.
(7) "Training monitor" means the certified hemodialysis technician who with limited accountability mentors skill building and monitors for safety. The training monitor does not replace or substitute for the preceptor.
(8) "End-stage renal disease" (ESRD) means the stage of renal impairment that appears irreversible and permanent, and requires either the replacement of kidney functions through renal transplantation or the permanent assistance of those functions through dialysis.
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(1) Minimum qualifications for hemodialysis technician, category G assistants to perform end-stage renal dialysis the applicant must have:
(a) A high school education or its equivalent;
(b) The ability to read, write and converse in the English language;
(c) Basic math skills including the use of fractions and decimal points; and
(d) Adequate physical ability, including sufficient manual dexterity to perform the requisite health care services.
(2) Documentation of the satisfactory completion of a skills competency checklist equivalent to, or exceeding the competencies required by these rules.
(3) Training and experience. The hemodialysis technician, category G assistant shall receive training, evaluation(s), and assessment of knowledge and skills to determine minimum level competency, as required by WAC 246-826-302.
(4) The dialysis facility forwarding an application for certification as a hemodialysis technician must verify the applicant has satisfactorily completed all of the core competencies and minimum training standards for hemodialysis training programs required by chapter 18.135 RCW and these rules. The dialysis facility must verify that the applicant is sufficiently qualified, skilled, and knowledgeable to perform all procedures to be delegated to the applicant upon certification.
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(2) Training program record retention requirements: The training program shall maintain the orientation checklists and any appropriate training documentation while the hemodialysis technician is employed with the health care facility or health care practitioner.
(3) The training program for new hemodialysis technicians must be a minimum of six to eight weeks. The hemodialysis technician shall complete training in both didactic and supervised clinical instruction. The training program shall (a) extend over a period of time sufficient to provide essential, sequenced learning experiences, which enables the trainee to develop competence and shall (b) show evidence of an organized pattern of instruction consistent with principles of learning and sound educational practices.
(4) Supervised clinical experience must provide opportunities for the application of theory and for the achievement of stated objectives in a patient care setting. Training through supervised clinical experience must include clinical learning experiences to develop the skills required by hemodialysis technicians to provide safe patient care. The preceptor must be physically accessible to the hemodialysis technician when the hemodialysis technician is in the patient care area.
(5) The dialysis facility may accept documentation of a hemodialysis technician's successful completion of training objectives in another dialysis facility if it is substantially equivalent to the core competencies described in WAC 246-826-303.
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Patient care.
(1) Data collection and communication. The hemodialysis technician must:
(a) Verify patient identification and dialysis prescription.
(b) Gather predialysis patient information necessary for treatment as required by facility protocols.
(c) Accurately calculate patient fluid removal and replacement needs.
(d) Monitor and verify treatment parameters during dialysis as required by facility protocols.
(e) Gather post dialysis patient information necessary to conclude treatment as required by facility protocols.
(f) Communicate and report patient, family or other care providers' concerns and/or needs to the nurse.
(g) Provide written documentation to the patient's medical record related to both routine treatment and unusual events.
(h) Recognize, report and document signs and symptoms related to:
(i) Hemodialysis vascular access complications.
(ii) Patient treatment complications.
(iii) Complications due to operator or equipment error.
(iv) Complications associated with allergic reactions.
(v) Complications associated with treatment anticoagulation.
(2) Basic hemodialysis treatment skills. The hemodialysis technician must be able to:
(a) Set up dialysis related supplies and equipment as required by a licensed health care practitioner prescription and facility policies and procedures.
(b) Prepare and mix additives to hemodialysis concentrates as required by facility procedure based on patient prescription.
(c) Prepare and administer heparain, saline, and lidocaine during treatment in standard hemodialysis doses.
(d) Provide routine care for and cannulate hemodialysis vascular accesses for treatment as required by facility policies and procedures.
(e) Initiate hemodialysis treatment as required by facility policies and procedures.
(f) Provide routine care for, initiate, and terminate hemodialysis treatments using central catheters as required by facility protocols.
(g) Terminate hemodialysis treatment as required by facility policies and procedures.
(h) Provide routine care for equipment post dialysis including rinsing, disinfecting and shutting down as required by facility policies and procedures.
(i) Draw required samples for laboratory testing as required by facility protocols and procedures.
(3) Hemodialysis treatment interventions. The hemodialysis technician must be able to:
(a) Administer oxygen to patient by cannula or mask.
(b) Initiate CPR.
(c) Provide initial response to patient complications and emergencies during treatment per facility procedures, including, but not limited to, the administration of normal saline per facility protocol.
(d) Respond to equipment alarms and make necessary adjustments.
(4) Education and personal development for entry-level hemodialysis technicians: The entry-level hemodialysis technician should be able to demonstrate a basic understanding of the following subjects:
(a) General orientation subjects for the new hemodialysis technician.
(i) Common manifestations of renal failure.
(ii) Principles of dialysis.
(iii) Dialyzer and concentrate use and prescription.
(iv) Basic concepts of hemodialysis water treatment and dialyzer reuse.
(v) Principles of fluid management.
(vi) Hemodialysis treatment complications and emergencies.
(vii) Standard precautions and the use of aseptic techniques.
(viii) Hazardous chemical use in the hemodialysis setting.
(ix) Use and care of hemodialysis vascular accesses.
(x) Common laboratory testing procedures and critical alert values.
(xi) Basic concepts related to dialysis patient dietary/nutrition requirements.
(xii) Common psychosocial issues related to aging, chronic illness and dialysis therapy.
(b) Facility requirements as required by written policies and procedures. The hemodialysis technician must:
(i) Maintain current CPR certification.
(ii) Demonstrate an understanding of facility requirements related to infection control and the use of hazardous chemicals.
(iii) Demonstrate knowledge of facility disaster plans and emergency evacuation routes.
(c) The hemodialysis technician must be able to demonstrate a basic understanding of the proper body mechanics for patient and self.
(d) Maintaining patient confidentiality related to medical and personal information.
(e) The hemodialysis technician must be able to demonstrate a basic understanding of the patient's rights and responsibilities per facility policies.
(f) The hemodialysis technician must be able to demonstrate a basic understanding of the Uniform Disciplinary Act of the state of Washington, chapter 18.130 RCW.
(g) The hemodialysis technician must be able to demonstrate a basic understanding of the role of hemodialysis technician patient care as it relates to professional interactions with:
(i) Patients, family members and other care providers.
(ii) Supervisory and administrative health care providers.
(iii) Peers and other facility employees.
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