Letter from ANNA to Indiana State Board of Nursing regarding the role of unlicensed personnel in dialysis and the legitimate role of registered nurses in delegating to and supervising such personnel.

March 15, 2004 

Ms. Kristen Kelley

Board Director

Indiana State Board of Nursing

Health Professions Bureau

402 West Washington Street, Room W066

Indianapolis, IN 46204

Dear Ms. Kelley: 

The American Nephrology Nurses’ Association (ANNA) is an organization of over 11,000 registered nurses nationwide, including over 250 in Indiana, who practice in all areas of nephrology. The majority of our members practice in outpatient dialysis settings. We are writing today to comment on your December 22, 2003, letter to Lana Richmond of ISDH regarding the role of unlicensed personnel in dialysis and the legitimate role of registered nurses in delegating to and supervising such personnel. Over the years, ANNA has worked successfully with many state Boards of Nursing in clarifying the uniqueness of the dialysis clinical practice setting, and we look forward to doing the same in Indiana.

It has come to our attention from a number of our members in Indiana that there has recently been created a great deal of confusion about the legitimate delegation of nursing tasks by registered nurses to unlicensed personnel in dialysis. We would like to comment on the December 22 letter and inform the Board more completely about the clinical practice of nursing and delivery of patient care in dialysis settings, and how that practice is consistent with the Indiana nurse practice act and the statements made in the letter. We will address and respond to the statements from the letter individually.

The letter begins and ends with the statement that “nurses should not be delegating tasks to non-licensed or non-certified individuals that require the exercise of professional nursing judgment.”

  • We agree with this statement. The tasks technicians perform when initiating, monitoring, and terminating dialysis do not require professional nursing judgment. Decisions regarding changes in treatment, as evidenced by changes in vital signs or patients’ expressions of complaints, are reported to the registered nurse for assessment and intervention decisions. The administration of heparin and saline, and sometimes intradermal anesthetic, at initiation of dialysis are based on physician orders and are not subject to individual judgment. Technicians give no other medications. Treatment parameters that are variable are also set by physician order, such as “target weight,” which determines how much fluid is to be removed during a treatment. In short, delegating the initiation, termination, and monitoring of patients on dialysis does not require professional nursing judgment and is therefore consistent with the Board’s expressed opinion.

The letter also states that a registered nurse may perform numerous services, including “delegating tasks which assist in implementing the nursing, medical, or dental regimen” (IND. CODE §25-23-1-1.1(b)(7)).

  • Once again, we agree. Nephrology nurses practicing in dialysis have delegated tasks, consistent with this and other areas of the statute, for over three decades in Indiana and throughout the United States.

The letter reads that it is appropriate for someone “to provide healthcare services which are delegated or ordered by licensed health professionals, if the delegated or ordered tasks do not exceed the scope of practice of the licensed health professionals under Indiana law.” IND. CODE  §25-23-1-27.1(b)(6)

  • This statement supports the current nursing practice in dialysis facilities. This language makes it clear that, since initiating and terminating dialysis, and administering heparin, saline, and intradermal anesthetics as part of the routine dialysis regimen are within the scope of practice of a registered nurse in Indiana, delegating those tasks to a trained dialysis technician does not exceed the scope of the law. Many family members are trained to perform dialysis in their homes under no supervision.

The letter goes on to say that "the authority to delegate tasks is not unlimited." There is no citation for that, and we can find nothing in the statute or regulations that limits the registered nurse’s delegatory authority beyond the requirement that they may “delegate and supervise only those nursing measures which the nurse knows, or should know, that another person is prepared, qualified, or licensed to perform.” (B4B IAC 2-2-2(8)).

  • Dialysis technician trainees undergo education and training on renal failure and dialytic therapy that is conducted and supervised by registered nurses, all of which is under the ultimate supervision of each facility’s Medical Director as required by federal regulation, such that the registered nurses in dialysis do know they are delegating tasks to individuals who are properly prepared to carry them out safely.

The letter adds, “it is unprofessional conduct for a nurse to delegate ‘nursing care, functions, tasks, or responsibility to others when the nurse knows, or should know, that such delegation is to the detriment of patient safety’.” 848 IAC 2-2-3(8).

  • We agree with that statement but assure you that nephrology nurses working in dialysis do NOT delegate tasks to unlicensed personnel to the detriment of patient safety. In fact, there is no data that the utilization of unlicensed hemodialysis technicians in Indiana for the past three decades has had a negative effect on the clinical outcomes of the recipients of care in dialysis facilities. In fact, the patient outcomes in Indiana are reported by CMS to be excellent.
  • Indiana is part of The Renal Network 9, along with Kentucky and Ohio. (The 18 ESRD Networks are contractors to the CMS and function in many ways similar to peer review organizations.)  In 2002, Indiana patients comprised 28 percent of the Network 9 patient population. The Renal Network 9/10 website at http://www.therenalnetwork.org/Data/2002AnnualReport.html, includes its 2002 Annual Report to CMS.
  • Since 1994, CMS has conducted the ESRD Clinical Performance Measures Project through the ESRD Networks to assist providers in improving patient care and outcomes. An annual report of the findings is published and is available on the Internet at http://www.cms.hhs.gov/esrd/1e.pdf.
  • The medical professionals of The Renal Network 9 have addressed the appropriate role of unlicensed patient care technicians in dialysis, including medication administration. A copy of their position statement is being sent to you along with this letter.
  • Clinical data compiled by The Renal Network in its 2002 Annual Report and by CMS in its 2002 Annual Report on the ESRD Clinical Performance Measures Project have indicated that patients in Network 9 have shown steady improvement in the quality of care and patient outcomes.
  • The percent of adult in-center hemodialysis patients in Network 9 receiving dialysis with a mean delivered Kt/V>1.2, an industry standard of care related to the adequacy of dialysis, from October through December 2001, was 89 percent. Only four other Networks had a higher percentage of patients (92) meeting that standard.
  • For another industry standard of care related to anemia management, the percent of adult in-center hemodialysis patients with a mean hemoglobin >11gm/dL in Network 9 during that same study time period, was 74 percent, only two percentage point difference between Network 9 and the national average.

With regard to the statement that “Clearly a registered nurse may delegate tasks, but he or she must supervise the person with delegated authority and that person must be qualified to perform the task:” We have previously addressed the training of the dialysis technicians, but would like to comment that unlicensed personnel in dialysis are under the ongoing supervision of the registered nurse during the course of the dialysis treatments. 

Finally, we agree with you once again that “practicing nursing without a license is a crime.” That goes without saying, and is certainly not unique to Indiana. In so stating, you reference IND. CODE §25-23-1-27. The dialysis technicians in Indiana are not “practicing nursing,” or otherwise violating any part of this referenced section of Indiana law. Their tasks are akin to other extracorporeal therapists, such as cardiopulmonary bypass technicians. 

Federal regulations recognize that the on-duty personnel carrying out dialysis treatments are predominantly unlicensed individuals, and do not require more than one licensed individual (RN, LPN, or MD) to be on-duty when patients are undergoing dialysis.

The conditions of coverage of suppliers of end stage renal disease services, found at 42CFR405, Sec.2162 Condition: Staff of a renal dialysis facility or renal dialysis center, require the following:

“Properly trained personnel are present in adequate numbers to meet the needs of the patients, including those arising from medical and nonmedical emergencies. (a) Standard: Registered nurse. The dialysis facility employs at least one full time qualified nurse responsible for nursing service. (See Sec. 405.2102.) (b) Standard: On-duty personnel. Whenever patients are undergoing dialysis: One currently licensed health professional (e.g., physician, registered nurse, or licensed practical nurse) experienced in rendering ESRD care is on duty to oversee ESRD patient care;

(2) An adequate number of personnel are present so that the patient/staff ratio is appropriate to the level of dialysis care being given and  meets the needs of patients; and (3) An adequate number of personnel are readily available to meet medical and nonmedical needs…” 

As of December 31, 2002, there were nearly 6,000 patients receiving care in 77 outpatient dialysis facilities throughout Indiana. (Patient data from CMS 2002 Annual Facility Survey. Facility data from CMS, June 2003, http://www.cms.gov/esrd/8e.pdf). The lifesaving treatment these patients must receive three times each week in their respective dialysis facilities is currently being threatened by this confusion. Nurses and experienced technicians are frightened to continue in their roles due to comments like “practicing nursing without a license is a crime” and it is “unprofessional conduct for a nurse to delegate” and threats of action by the Board of Nursing. It is imperative that this situation be resolved immediately and ANNA will do whatever it can to be a resource to the Board to that end.

We have attached for your reference copies of ANNA’s position statements on The Role of Unlicensed Assistive Personnel in Dialysis Therapy, Delegation of Nursing Care Activities, and the Joint Position Statement of ANNA and the National Association of Nephrology Technicians/ Technologists on Unlicensed Personnel in Dialysis.

We hope this information is helpful to the Board. We will be happy to meet with you at your earliest convenience to discuss this important matter that is fast approaching emergency status in Indiana. 

Sincerely,

Caroline S. Counts, MSN, RN, CNN

President

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