Letter from ANNA to the Centers for Medicare and Medicaid Services (CMS) regarding the Conditions for Coverage for ESRD Facilities Proposed Rule about having a registered nurse present when patients are being treated

July 3, 2007

Barry M. Straube, MD
Chief Medical Officer
Director, Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD  21244

Dear Barry:

On June 14, a delegation from the American Nephrology Nurses' Association (ANNA), consisting of Charlotte Thomas-Hawkins, Linda Flynn, Debra Castner and myself, made a visit to the Centers for Medicare and Medicaid Services (CMS) in Baltimore.  We met with Teresa Casey, Lynn Riley and Steve Miller to provide additional support for the Conditions for Coverage for ESRD Facilities Proposed Rule § 494.180(b) (2) The governing body or designated person responsible must ensure that a registered nurse is present at all times that patients are being treated.  We greatly appreciate having an opportunity to meet with them and to discuss this very important issue. 

During our discussion, Charlotte and Linda (both professors at Rutgers University School of Nursing, New Brunswick, NJ) presented preliminary results of their comprehensive research study entitled, “The Work Environment and Nurse-Reported Outcomes in Dialysis Centers.”  This study explored the impact of system factors, including registered nurse staffing levels on nurse-reported patient outcomes in hemodialysis units.  After the presentation, CMS staff requested Drs. Thomas-Hawkins and Flynn provide written data to share with department personnel that are currently reviewing the proposed rules.  Drs. Thomas-Hawkins and Flynn prepared the White Paper [PDF file 88K] describing their research that I am attaching, along with their respective biographical sketches, to this e-mail.

During our meeting, we also discussed the topic of state regulations.  We were asked how many states currently require a registered nurse be present when a patient is being dialyzed.  At the time, I did not have the answer, but have since been able to gather the information and am including it here.  This information is from ANNA’s state health policy directors and from states departments of health web sites.  Twenty-eight states currently require dialysis facility licensure. Some of the language is too vague for me to be certain of the intent, however, it appears that between 23 and 26 of the licensure states already require what Proposed Rule § 494.180(b) (2) would require; an RN present at all times that a patient is being dialyzed.  The Boards of Nursing in all 50 states do require an RN to provide supervision/delegation for all unlicensed personnel in dialysis facilities.  We feel strongly that this should be a standard throughout the country, therefore ANNA supports keeping the proposed rule as written in the final rule. 

I would like to thank you and the members of the Office of Clinical Standards and Quality for taking the time to hear our concerns.  Please let me know if I can provide additional information. 


Sandra M. Bodin, MA, RN, CNN

cc: Teresa Casey, CMS
Judith Kari, CMS
Lynn Riley, CMS
Steve Miller, CMS
Board of Directors