Transcript Document

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
Discussion Outline
Why did CMS publish the ESRD Conditions for
Coverage?
An Overview of the Conditions – Policy Focus
versus Operational Guidance
Conclusion
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.
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
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
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.
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
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
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
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
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.
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
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
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.
Patient Care Continued
§494.90 Condition: Patient Plan of Care
• The plan of care must include the basis for nonreferrals 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.
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.
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.
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.
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 12month period
• Service limitation
• Scope of requirements limited to certain conditions
• Documentation requirements
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
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.
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.
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
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
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 (phasein)
• Water Treatment System Technicians – complete
training program approved by the medical director
and governing body
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
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
Administration Continued
§494.180 Condition: Governance
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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
Contact Information
for the ESRD CfCs
Lynn Riley
[email protected]
410-786-1286
Lauren Oviatt
[email protected]
410-786-4683