ESRD Conditions for Coverage Overview and Training

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 facilitys 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 RD522004 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
  RD472002 and RD472003/A12003 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
  facilitys 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
  patients 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
  physicians 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 patients home by
  facility personnel in accordance with the
  patients 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 facilitys
  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 units
  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 patients 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

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Contact Information for the ESRD CfCs

• Lynn Riley
• lynn.riley_at_cms.hhs.gov
• 410-786-1286
• Lauren Oviatt
• lauren.oviatt_at_cms.hhs.gov
• 410-786-4683