ANNA submits comments on Centers for Medicare and Medicaid Services End Stage Renal Disease Draft Interpretive Guidelines

Centers for Medicare and Medicaid Services
Survey and Certification Group- IG Comments
Attention: Debbie Davis
Mail Stop S2-12-25
7500 Security Blvd.
Baltimore, MD 21244

Re: Comments on Centers for Medicare and Medicaid Services End Stage Renal Disease (ESRD) Draft Interpretive Guidelines

Dear Ms. Davis:

The American Nephrology Nurses' Association (ANNA) is pleased to have the opportunity to provide public comments on the Centers for Medicare and Medicaid Services' (CMS) End Stage Renal Disease (ESRD) Draft Interpretive Guidelines. ANNA has appreciated the willingness of the CMS staff to work collaboratively during all aspects of the rulemaking process. ANNA looks forward to working with CMS in the implementation of the final regulations.

ANNA is a professional nursing organization of more than 12,000 registered nurses practicing in nephrology. ANNA members are intimately involved in the supervision and delivery of care to adults and children with kidney disease. ANNA members work in a variety of settings including dialysis facilities, transplant centers, Chronic Kidney Disease (CKD) clinics, acute care, ambulatory clinics and long-term care.

Overview of ANNA's Participation in Development of the Conditions for Coverage

ANNA supports CMS's efforts to create a patient outcome-oriented environment at ESRD facilities in the implementation of the conditions of coverage. ANNA's active participation in providing public comments on the proposed rule for conditions of coverage, our meetings with CMS officials, and our comments on the interpretive guidelines are based upon our mission as the leading nephrology nursing organization to ensure that patient care and safety remain the most important factors in the implementation of the final rule.

The following is a brief overview of ANNA's previous comments and interactions with CMS on the proposed conditions of coverage. ANNA provides the following past comments as attachments for your review:

  • On May 5, 2005, ANNA submitted Comments to CMS on the Conditions for Coverage for ESRD Facilities Proposed Rule.
  • On September 14, 2006, ANNA representatives met with officials from CMS to discuss the progress of the Conditions for Coverage for ESRD Facilities Proposed Rule and to provide additional input about the role of Registered Nurses (RNs) in the delivery of care to ESRD patients.
  • On June 14, 2007, a delegation from ANNA met with CMS staff to provide additional support for the Conditions for Coverage for ESRD Facilities Proposed Rule § 494.180(b) (2), which reads, "the governing body or designated person responsible must ensure that a registered nurse is present at all times that patients are being treated."
  • On July 3, 2007, at the request of CMS staff, ANNA provided a White Paper prepared by Drs. Thomas-Hawkins and Flynn that summarized data from their comprehensive research study entitled, "The Work Environment and Nurse-Reported Outcomes in Dialysis Centers." This study explored the impact of system factors, including RN staffing levels on nurse-reported patient outcomes in hemodialysis units.

ANNA Comments on CMS Draft Interpretive Guidelines

ID# 124
ANNA is concerned about any requirement for labeling of "clean" and "dirty" areas or sinks in treatment areas. There is very little agreement on how this should be done. ANNA also has concerns about the statement "patients with risk factors for HIV should be tested." We urge CMS to clarify how these patients would be identified.

ID# 372
ANNA believes this guideline should reflect the practice patterns in dialysis units. Numerous professional practitioners are competent to diagnose and treat adverse dialyzer reactions. Advanced Practice Nurses, defined as either a Nurse Practitioner or Clinical Nurse Specialist, are widely employed in dialysis facilities, and in many clinics provide the majority of ESRD related care. We urge CMS to consider this fact in the drafting of this guideline.

ID #456
ANNA recommends this guide be clarified to say that only professional staff should discuss advanced directives with patients.

ID# 460
ANNA encourages CMS to amend the language in this guideline to clarify that an Advanced Practice Nurse is qualified to inform patients about their disease process and treatment options.

ID# 464
ANNA appreciates that CMS has defined complaint and grievance. However, IDs #465, #466 and #465 refer only to grievance. ANNA suggests that the expectation to investigate complaints be included here as well.

ID #469
ANNA believes this guideline should support a zero tolerance policy for patient behavior, written or verbal, that presents a threat to the safety of others. ANNA feels that such behavior should result in an immediate discharge from the facility.

ID #475 and ID# 476
ANNA urges CMS to modify the description of an "interdisciplinary team" to include "Advanced Practice Nurse or Physician Assistant" instead of "physician extender." Professionals have their education, credentials and title recognized in government published guidelines so they can be appropriately credited for their participation in patient care.

ANNA believes that the patient's comprehensive assessment must include, but is not limited to, the evaluation of current health status and medical conditions, including co-morbid conditions. We would expect to see documentation of a history of the etiology and progress of the patient's kidney disease and a history of co-morbid conditions. Furthermore, ANNA feels that an appropriate physical assessment must include a physical exam to update any components of the patient's current medical status. ANNA believes that histories and physicals from hospital admissions should address the patient's current presentation and health status, address the renal disease aspects of the patient's medical history and should be updated as part of the re-assessment requirement as stated in §494.80(d) of the proposed rule.

ID# 486
ANNA encourages CMS to clarify the term "facilitate the assessment" for a living donor.

ID# 502
ANNA suggests the statement "There should be evidence the patient has consented or committed to any change in behavior or treatment proposed in the plan" be changed to "There should be evidence of patient acknowledgement of any change in behavior or treatment proposed in the plan." This evidence is easier to demonstrate.

ID# 505
ANNA is concerned that many facilities are unable to obtain contracts to provide blood because the service is cost prohibitive. We urge CMS to add that a referral to an ambulatory or hospital infusion center is acceptable under this interpretive guideline.

ID# 513
ANNA encourages CMS to clarify whether some form of documentation, such as transplant physician dictation or follow up letter to the patient from the coordinator is required to demonstrate the completion of the required testing.

ID# 518
ANNA encourages CMS to clearly state "the registered nurse" here rather than use the broader term "nurse" because licensed practical nurses cannot fulfill this responsibility.

ID# 523
ANNA believes that patient involvement/independence in completing the transplant work-up is a very important aspect of being a transplantation candidate, and that this is not reflected in the draft guidelines.

ID# 524
ANNA understands that the regulations on transplant centers require written policies and procedures for ongoing communication with a dialysis patient's local dialysis facility.

ANNA encourages CMS to clarify whether the requirement for frequency of communication between dialysis facilities and transplant centers applies equally to both entities.

ID# 550
ANNA suggests that the line "This team member must be a licensed health care professional" be deleted, as redundant of the definition of the interdisciplinary team (i.e., only the MD, RN, MSW and RD are named as members of the team, and they are all licensed healthcare professionals).

ID# 618
ANNA suggests adding, "Recognize that a licensed practical nurse cannot be in charge of a unit without specific authority from a state board of nursing. In addition, many, if not all, state boards of nursing prohibit a licensed practical nurse from supervising a registered nurse. "

ID# 667
ANNA suggests revising "There must be a qualified registered nurse on duty and available at all times when patients are being treated" to say "There must be a qualified registered nurse on duty, available and present in the clinical area at all times when patients are being treated." ANNA applauds CMS for including the nursing research statement in this interpretive guideline. In addition, recent data not only demonstrates evidence-based positive correlation between the availability of professional nursing care and patient outcomes, but also in improving patient safety

ANNA appreciates having the opportunity to provide comments and suggestions in the development of the proposed rule and interpretative guidelines on the CMS Conditions of Coverage for ESRD facilities. ANNA looks forward to reviewing the final published rule and continuing to work with CMS to ensure that ESRD patients are receiving safe, quality care.


Sandy Bodin, MA, RN, CNN
American Nephrology Nurses' Association