1. ESRD Conditions for Coverage Overview and Training Lynn M. Riley, RN, MA Lauren Oviatt Clinical Standards Group Office of Clinical Standards and Quality Centers for Medicare & Medicare Services August 7, 2008

2. Discussion Outline Why did CMS publish the ESRD Conditions for Coverage? An Overview of the Conditions – Policy Focus versus Operational Guidance Conclusion

3. ESRD Conditions for Coverage Conditions for Coverage (CfCs) are minimum health and safety standards that are the foundation for improving care and protecting beneficiaries. Facilities must meet CfCs in order to be paid by Medicare and Medicaid. State Surveyors use these regulations to evaluate providers’ compliance with the laws.

4. The Here and Now Without the How The ESRD Final Rule, or the Conditions for Coverage, published on April 15, 2008 Effective date – October 14, 2008 Interpretive Guidance being developed – It is not yet finished. Importance of the preamble, including comments and responses

5. Patient Safety Overview §494.30 Condition: Infection Control Incorporates CDC guidelines – “CDC, Morbidity and Mortality Weekly Report, Volume 50, number RR05”, dated April 27, 2001 (pages 18 to 28). Requires oversight to include biohazard and infection control policies Requires separate isolation rooms for HBV infected patients

6. Patient Safety Continued Requires all clinical staff to report infection control issues to the dialysis facility’s medical director. Requires the dialysis facility to analyze and document incidences of infection to identify trends and to establish baseline information; and to make recommendations to minimize infections. Requires the dialysis facility to report all incidences of communicable diseases as required by Federal, State, and local regulations.

7. Patient Safety Continued §494.40 Condition: Water and dialysate quality Incorporates AAMI RD52:2004 – “Dialysate for Hemodialysis” guidelines Implements AAMI action levels for water and dialysate Bacterial contamination Increased frequency of Chlorine/Chloramine testing Requires a corrective action plan for water testing results that meet AAMI action levels Requires facilities to perform active surveillance of patients during and following dialysis

8. Patient Safety Continued §494.50 Condition: Reuse of hemodialyzers and bloodlines Incorporates by reference the ANSI/AAMI “Reuse of Hemodialyzers” guidelines found in the ANSI/AAMI RD47:2002 and RD47:2003/A1:2003 guidelines Hepatitis B positive patents are excluded from reuse Special actions required for adverse events related to reuse

9. Patient Safety Continued §494.60 Condition: Physical Environment Requires a defibrillator or automated external defibrillator (AED) in every dialysis facility Incorporates the 2000 Life Safety Code – delayed effective date (February 9, 2009) for 494.60(e)(1) New requirements specific to emergency preparedness Requires the facility to maintain a comfortable temperature within the facility

10. Patient Care Overview §494.70 Condition: Patients’ rights. Facilities must inform patients of their rights when they begin dialysis treatment in a way that the patient can understand Facilities must inform patients of their right to execute advance directives

11. Patient Care Continued §494.70 Condition: Patients’ rights. Patients must be informed of the facility's internal grievance process; Patients must be informed regarding the facility’s discharge and transfer policies; and The facility must prominently display a copy of the patients’ rights, including the telephone numbers for the appropriate ESRD Network and State Survey Agency.

12. Patient Care Continued §494.80 Condition: Patient Assessment. Requires a comprehensive patient assessment on every patient to be developed by the Interdisciplinary Team (IDT) The IDT consists of, at a minimum, the patient or patient’s designee, a physician treating the patient for ESRD, a registered nurse, a social worker, and a dietitian. New patients must have an assessment completed within the latter of 30 days or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session

13. Patient Care Continued §494.80 Condition: Patient Assessment The follow-up comprehensive assessment must occur within 3 months after the completion of the initial assessment Stable patients must be reassessed at least annually Unstable patients must be reassessed at least monthly

14. Patient Care Continued §494.90 Condition: Patient Plan of Care The IDT must develop and implement a plan of care that specifies services necessary to address patient needs identified in the comprehensive assessment.

15. Patient Care Continued §494.90 Condition: Patient Plan of Care The plan of care must include the basis for non- referrals for transplantation, and the dialysis facility must communicate with the transplant center at least annually. Initial plan of care must be implemented within the latter of 30 calendar days after admission to the dialysis facility, or 13 outpatient hemodialysis sessions beginning with the first outpatient session.

16. Patient Care Continued §494.90 Condition: Patient Plan of Care Implementation of monthly or annual plan of care updates must be performed within 15 days of the completion of any additional patient assessments. The facility must ensure that a physician, nurse practitioner, clinical nurse specialist, or physician’s assistant providing ESRD care sees the patients at least monthly.

17. Patient Care Continued §494.100 Condition: Care at home Home care must be equivalent to in-center dialysis The IDT must closely monitor services provided and include visits to the patient’s home by facility personnel in accordance with the patient’s plan of care. In addition, home dialysis monitoring includes retrieval and review of self-monitoring data at least every 2 months.

18. Patient Care Continued §494.110 Condition: Quality assessment and performance improvement. The QAPI program is developed and implemented by the dialysis facility The program must be data-driven and reflect the complexity of the dialysis facility’s organization and services, to include those services under arrangement. The facility must continuously monitor performance, take actions that result in actual care improvement, and track performance to sustain improvements.

19. Patient Care Continued §494.120 Condition: Special purpose renal dialysis facilities. Dialysis on a Short-term basis at special locations Approval period may not exceed 8 months in a 12- month period Service limitation Scope of requirements limited to certain conditions Documentation requirements

20. Patient Care Continued §494.130 Condition: Laboratory Services Provide or make available laboratory services to meet the needs of the ESRD patient Lab services must be furnished by or obtained from a facility that meets lab services as specified in part 493

21. Administration Overview §494.140 Condition: Personnel Qualification Medical Director – Board-certified physician in internal medicine or pediatrics by a professional board who has completed a board-approved training program in nephrology and has at least 12-months of experience providing care to patients receiving dialysis. If physician, with credentials mentioned above is not available, another physician may direct the facility, subject to the approval of the Secretary.

22. Administration Continued Nurses Nurse Manager – fulltime employee of the facility, Registered Nurse, at least 12-months of clinical nursing experience, and additional 6 months of experience in providing nursing care to patients in maintenance dialysis. Self-care and home dialysis training nurse – RN, at least 12 months experience providing nursing care, additional 3 months experience in specific modality for which the nurse will provide self-care training.

23. Administration Continued Charge Nurse – RN, LPN, or LVN who meets practice requirements in State employed, 12 months experience in providing nursing care, additional 3 months experience providing nursing care to patients on maintenance dialysis, and meet State supervision requirements for LPN or LVN. Staff Nurse – RN or LPN who meets practice requirements in State employed

24. Administration Continued Dietitian –Registered dietitian with the Commission on Dietetitic Registration, and have minimum of 1 year professional work experience in clinical nutrition as a registered dietitian. Social Worker – MSW with a specialization in clinical practice from school of SW accredited by the Council on Social Work Education, or served at least 2 years as a SW, 1 year was in a dialysis or transplant program prior to 9/1/1976 and has a consultative relationship with a MSW

25. Administration Continued Patient Care Dialysis Technicians – meet all applicable State requirements for education, training, credentialing, competency, standards of practice, certification, and licensure in State employed as a PCT, high school diploma or equivalent, completed training program, certified under State program or national commercially available certification (phase- in) Water Treatment System Technicians – complete training program approved by the medical director and governing body

26. Administration Continued §494.150 Condition: Responsibilities of the medical director Responsible for the delivery of patient care and outcomes in the facility Responsible for patient care staff education, training and performance Develop, review, and approval of the unit’s patient care policies and procedures

27. Administration Continued §494.170 Condition: Medical Records Safeguard patient records against loss, destruction or unauthorized use Medical records must be complete and information kept centralized in the patient’s record Patient records must be maintained for 6 years form the date of the patient's discharge, transfer or death Transferring patients – medical record information must be sent within 1 working day of the transfer

28. Administration Continued §494.180 Condition: Governance Designating a CEO or Administrator Adequate number of qualified and trained staff Medical staff appointments Furnishing services directly Internal grievance process Involuntary discharge and transfer policies and procedures Furnishing data and ESRD program administration – effective 2/1/09. Relationship with the ESRD network

29. Contact Information for the ESRD CfCs Lynn Riley lynn.riley@cms.hhs.gov 410-786-1286 Lauren Oviatt lauren.oviatt@cms.hhs.gov 410-786-4683