Letter from ANNA to the Centers for Medicare and Medicaid Services (CMS) regarding the Medicare Program; Hospital Conditions of Participation: Requirements for Approval and Re-approval of Transplant Centers to Perform Organ Transplants; Proposed Rule;...

June 3, 2005

The Honorable Mark McClellan

Administrator

Centers for Medicare and Medicaid Services

Department of Health and Human Services

Attention: CMS-3835-P

Room 445-G

Hubert H. Humphrey Building

200 Independence Avenue, SW

Washington, DC  20201

Re:      Comments on Hospital Conditions of Participation: Requirements for Approval and Re-approval of Transplant Centers to Perform Organ Transplants; Proposed Rule; CMS-3835-P

Dear Administrator McClellan:

The American Nephrology Nurses’ Association (ANNA) is the professional nursing organization representing over 12,000 registered nurses (RNs) who care for patients with chronic kidney disease. A number of our members practice in transplant settings in a variety of roles including management, organ procurement and transplant coordination, living donor and family support, and the provision of both direct and indirect care to chronic kidney disease patients during the transplant evaluation process, and those awaiting or undergoing transplantation. As such, our members are heavily invested in the proposed rule revising the Conditions of Participation for Hospitals as it relates to Requirements for Approval and Re-approval of Transplant Centers to Perform Organ Transplants.

CRITERIA FOR CENTERS PERFORMING LIVING DONOR TRANSPLANTS

ANNA agrees that the development of standard definitions and procedures for centers performing living donor transplants is important. This is an excellent proposal, as current practice differs widely among living donor evaluations, selection and follow-up. We noted several references in the preamble to the problem of staffing shortages. It is important that the Agency recognizes that staffing issues in the transplant center can affect patient outcomes. This is also an important issue in terms of promoting patient safety.

CENTERS PERFORMING PEDIATRIC TRANSPLANTS

We are in agreement with this proposal. The percentage of pediatric transplant patients in a given transplant center should be considered rather than grouping Medicare approval for both adult and pediatric transplant patient services together.

OUTCOME MEASURE REQUIREMENTS

Data Submission and Outcome Measure Requirements for Initial Approval of Transplant Centers, proposed section 482.80, related to data submission: Certainly this requirement will raise the bar for all programs to improve performance. The issue is how best to implement it. This requirement will involve dedicated data coordinators, preferably nurses, but at least personnel who have a full understanding of the transplant arena so that accurate data is submitted. ANNA suggests interfacing CMS and UNOS data systems to avoid multiple forms. Additionally, kidney acquisition cost funds could be allocated for the purchase of computer software that could interface with local dialysis centers. This process will enable information regarding patients on transplant waiting lists and in the evaluation process to be shared between these two points of care to improve the quality and timing of communication, and ultimately the quality of care.

PATIENT AND LIVING DONOR SELECTION

Transplant Center Process Requirements 482.90 and 482.92

Regarding Patient and Living Donor Selection (482.90), many of the recommendations are already in place in many centers. We agree that transplant centers should have identified criteria for patient selection as long as some flexibility is permitted, since there are significant variations in patient populations between centers. The patient care team should be the ultimate decision maker.

Requiring documentation of these criteria in the medical record will result in increased staff time and increased cost. We agree that all candidates should have a psychosocial evaluation and that the medical record must contain documentation of candidates’ blood type for organ recovery and receipt (482.92). However, UNOS already mandates two different labs verifying blood type and two different people verifying entry of blood type on the UNOS database, in addition to written documentation of blood type compatibility prior to transplant surgery. The unfortunate cases where harm related to blood type incompatibility has occurred involved circumvention of existing systems. More regulations will not prevent those who choose to circumvent the system from doing so. We agree that living donor selection criteria and donor suitability should be determined and documented, and that the living donor should receive medical and psychological evaluations.

Regarding Patient and Living Donor Management (482.94 and 482.94(c)), the suggested “standard for waitlist management and timely notification to OPTN” includes excellent recommendations, especially with the goal of “standard.” We all want to accommodate the OPTN’s need for timely placement of organs while assuring patients will not be inactivated due to clerical or administrative inefficiency. The implementation of these requirements is very much affected by the primary source of current patient data coming from the dialysis facilities and other clinicians caring for the patients outside the transplant center. The transplant center is at a disadvantage because generally it is not the primary care provider for these patients. Again, computer systems that can interface between transplant centers and dialysis facilities would help with this. The requirement for a dietitian for donors who "may need dietary modifications permanently or temporarily" and who "recommends, counsels and monitors" donors implies ongoing involvement with a potential donor that very likely may not be acceptable for continued evaluation (under current practice, if BMI is 30 or greater). ANNA believes if our interpretation is correct, that the transplant center cannot take on the role of primary care provider for the unacceptable donor as it is beyond the scope of the center.

Quality Assessment and Performance Improvement (QAPI) 482.96

ANNA applauds the inclusion of a requirement and the suggestions for continuous quality improvement activities for the monitoring and evaluation of all transplant centers. The tracking of objective measures and adverse events provides an impetus for the centers to scrutinize and improve their performance, especially when made public such that they are publicly compared to their peers.

HUMAN RESOURCES

Condition of Participation: Human Resources (482.98(b)). ANNA agrees that a primary transplant surgeon and a transplant physician are necessary in each center.

Regarding 482.98(c), ANNA wholly supports the standard requiring a clinical transplant coordinator. We believe that, with very few exceptions, the preparation for the kidney transplant coordinator role should be RN education and experience. We agree that for those non-RN exceptions, certification of coordinators by ABTC should be mandatory as a means of documenting they have comprehensive knowledge of their role. However, for the experienced RN, this requirement overlooks many of the other credentialing bodies that may be as, or more, appropriate to kidney transplantation. The International Transplant Nurses Society (ITNS) and the Certified Nephrology Nurse (CNN) examinations would also be appropriate. We believe that, while certification is highly desirable for RNs, CMS should not endorse a particular transplant nursing exam, nor make it mandatory for RNs.

Resource commitment (482.98(e)). ANNA agrees that all the listed resources are important but we wish to point out the omission of the very important resource of patient education. While it may be assumed that this is an activity inherent in all patient care and has traditionally been the purview of nursing, the specification of patient education as a resource highlights its importance in helping patients assume as much management of their care as possible and assuring positive outcomes.

PATIENTS’ AND LIVING DONORS’ RIGHTS

ANNA fully supports the inclusion of all eight items listed in the proposed rule for both the transplant recipient and the living donor informed consent. The concept of improved informed consent (482.102(b)) for donors pertaining to the evaluation process and surgery is a very positive step in continuing to safeguard the patient and the team. With this information in writing and signed by the potential donor, the potential liability of the team is decreased regarding the explanation of the major facts and potential outcomes of donation to the donor. However, not every possible risk factor, complication, or adverse event from donating or receiving a kidney transplant can be predicted.  It is also very important to explain to patients what NOT to expect, so they can have realistic expectations for the therapy. With regard to donors, we suggest a statement be included in consent documents that describes that the determination of the risks to a donor are dependent upon, and limited by, the information and history supplied to the transplant team by the donor.

In the preamble, comments were requested regarding the inclusion of a living donor advocate separate from the transplant team. We agree with ACOT that a living donor information center be created, with specific education, written and verbal. However, we believe a donor advocate position separate from the team sets up the donor advocate to work with no support and could lead to the development of a potentially adversarial relationship with the transplant center, as we have seen historically with self-appointed advocates. It is not in a patient’s best interest to have a fragmented team. It is perfectly reasonable to appoint a nurse or social worker within a center to a donor advocacy position, with no contact with potential recipients, thus maintaining objectivity and avoiding conflict of interest. Historically, the transplant health care team first serves to protect the donor against potential adverse outcomes. Careful screening and extensive discussion regarding the potential for complications are part of the transplant process. 

ALTERNATIVE PROCESS TO RE-APPROVE TRANSPLANT CENTERS

This alternative process to re-approve transplant centers seems reasonable. However, the feasibility of random sampling is questionable and perhaps all centers should be surveyed every three years so all centers are viewed equally.

GENERAL COMMENT

ANNA believes that the proposed regulations are positive and designed to improve patient care and outcomes for transplant patients and their living donors. The proposed changes will also serve to standardize the care provided to patients.  

ANNA’s greatest concern overall is that, taken in its entirety, the regulations will create the need for many more additional nurse hours than are estimated here, and there is no indication of where funding for this increase in personnel will come from. Medicare coverage does not extend for most transplant patients for more than three years.Funding for pre-transplant activities often comes in part from kidney acquisition charges, but this is not available for post-transplant activities. Without an increase in reimbursement rates, it will be difficult to provide quality care within these proposed guidelines.

We would like to call your attention to a most significant omission -the potential role that the Advanced Practice Nurse (APNs) could play in assuring that these regulations would be implemented as envisioned. APNs have demonstrated both quality patient outcomes and cost effectiveness in the provision of care.

Finally, regarding the overall tone of these proposed regulations, ANNA would suggest that, along with protecting patient rights and promoting the best care possible, it is important that patients bear some responsibility for their own care. Healthcare is a partnership between patient and caregiver. We believe it is appropriate to require that, throughout the patient’s medical history and the evaluation process, potential recipients should show evidence of taking an active role in their care management to be selected for transplantation. It is not the sole responsibility of the transplant center or dialysis facility to see that a patient is transplanted successfully. It is also the responsibility of the patient. A condition requiring a program for promoting self-management would be a very positive addition to these excellent proposed conditions for coverage.

ANNA wishes to thank CMS for the opportunity to review and provide comment on these proposed Conditions of Participation.

Sincerely,

Suzann VanBuskirk, BSN, RN, CNN

ANNA President

cc: ANNA Board of Directors