Transcript Demystifying the New Regulations: A User’s Guide to the

Demystifying the New
Regulations: A User’s Guide to
the Conditions for Coverage
Jan Deane, RN, CNN
Network 11 Annual Meeting
October 3, 2008
With a Special Thanks…
To Glenda Payne and Judith Kari for their
assistance in putting this presentation
together.
Disclaimer
Although this presentation has been
reviewed by CMS, it does not substitute for
facility’s responsibility to become familiar
with all the regulations and make all
necessary changes to be in compliance with
the new regulations by October 14, 2008.
Chronic Hemodialysis
• First successful patient in 1960
• Home hemodialysis became popular due to
the high cost of treatment
• Patient selection became an important part
of the process
• “Who shall receive care
when not all can
receive care?”
Medicare Coverage for Dialysis
• Public Law 92-603, Section 2991
• Dialysis and transplant would be covered
under the Medicare program regardless of
age
• Dialysis became available for anyone
…Then in 1976…
The Long Journey Began
The ESRD Regulation Timeline
• 1976: First ESRD regulations published
• 70’s-90’s: Technical updates
• 1994: Community Forum Meeting to begin
complete rewrite of ESRD regulations
• 2008: New ESRD regulations published
4
1994 Community Forum:
Outcome
Change in Regulatory Focus
From
• First: Paper reviews
To
• First: Patient safety
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–
–
–
Water
Reuse
Infection Control
Physical Environment
1994: Change in the Survey
Process
From a focus on:
• Policies
• Procedures
• Personnel
records
To a focus on:
• Reviewing data
• Observing care
• Interviewing patients
• Interviewing the
people doing the
work
1994: Change in the Survey
Process
From a focus on:
To a focus on:
Structure
Outcomes
• Practices: water
treatment results, dialysis
adequacy
• Data: Dialysis Facility
Reports
• Community-set minimum
standards
Common Themes on the
Long Journey
• CMS & Kidney Community partnership
• Survey process is driven by outcomes &
data, not structure & paper
• Striving for consistency & common
understandings
Rationale Behind the Changes
Rationale for ESRD Regulation
Changes
Increasing realization of the need for
regulatory support for an outcomes
focus across provider types
• Needed to drive improvements in care
• Critical if CMS moves to value-based
pricing
• Necessary if CMS moves to bundled
reimbursement for ESRD care
Reasons for Change
• Changes in technology
– Water treatment: more complex
– Changes in dialysis equipment
• Differences in care delivery
– 1970’s: few technicians; regulations are
silent
– 2008: technicians provide most direct care;
public is demanding regulation
Reasons for Changes
• Evidence Based Practice: ESRD community
coming to consensus on minimum standards of
care
– RPA’s Adequacy of Dialysis Report
– K/DOQI Guidelines
– Fistula First Breakthrough Initiative
• QAPI: accepted process of quality assessment
across provider types
• Electronic data submission required to keep
pace with growing ESRD population & need for
current data
Introducing the new
Conditions for
Coverage
October 14, 2008
So what’s new??
Subpart A: General Provisions
Subpart B:
Patient Safety
494.30: Infection Control
• Official adoption of the CDC Guidelines
– “Recommendations for Preventing
Transmission of Infections Among Chronic
Hemodialysis Patients” MMWR 4/27/2001
• More focus – Condition level importance
• Moved higher in the survey process
• PPE Changes – GOWNS not APRONS!
494.30: Infection Control
• Isolation rooms for HBV infected patients
– All new facilities built after 2/9/2009
– Older facilities may use a separated area
• Infection control issues
– Medical director involvement
– QI process
• Develop tracking process
• Use comprehensive QI process to understand
494.40: Water and Dialysate
Quality
• Meet AAMI standards for water and dialysate
purity
– “Dialysate for Hemodialysis” ANSI/AAMI RD52:2004
• Increased frequency of chlorine/chloramine
testing
• Quality assurance plan for adverse occurrences
that assures patient safety
494.50: Reuse of Hemodialyzers
and Bloodlines
• No reuse for HBV patients
• Adherence to AAMI Guidelines
– “Reuse of Hemodialyzers” ANSI/AAMI
RD47:2002
• Expanded quality assurance processes
including suspending reuse in the presence
of clusters of adverse patient reactions
494.60: Physical Environment
• Patient care environment
– Comfortable temperature
– Patient privacy
– Patients within view of care staff including
vascular access and line connections
494.60: Physical Environment
• Emergency Preparedness
– Staff training
• Medical emergencies – CPR certification
• Non-medical emergencies including weather
related emergencies
• Emergency equipment
• Patient Education
• Disconnect procedure
• Where to go in the event of an emergency
494.60: Physical Environment
• Emergency Preparedness
– Equipment
• Oxygen, airways, suction
• Defibrillator or Automatic External Defibrillator
– Exemption for hospital based units with access
to hospital resuscitation team if response is
within a timely manner (4-5 minutes)
494.60: Physical Environment
• Fire Safety
– Compliance with the applicable sections of the
2000 Life Safety Code (National Fire Protection
Association)
– Exemption to sprinklered section if facility was
built before 1/1/2006 and state law permits
– Must follow State law if State law is more strict
than the LSC provisions.
Subpart C: Patient Care
494.70: Patient Rights
• Not a lot of changes but mostly expansion and
clarification of existing patient rights
• Addition of several new patient rights
– Advance Care Planning discussions
– Information regarding all treatment modalities and
including scheduling options
– Grievances – expanded to 3 tags
494.70: Patient Rights
• Involuntary Discharge
– Included in Patient Rights Condition as well as
patient assessment and governance
– Under this Condition, specifically information
regarding the facility policy for involuntary
discharge AND the right to written 30 day
notice
494.80: Patient Assessment
• Interdisciplinary team involvement – at a
minimum
–
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–
–
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Patient or patient’s designee
Registered nurse
Patient’s nephrologist
Social worker
Dietitian
494.80: Patient Assessment
• Comprehensive initial assessment
– All new patients within 30 days or 13 treatments
• Follow-up comprehensive reassessment
– All new patients within 3 months following the
initial assessment
• Additional reassessments
– Stable patients – annually thereafter
– Unstable patients – monthly until stable
494.80: Patient Assessment
• What is an unstable patient?
–
–
–
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Extended or frequent hospitalizations
Marked deterioration in in health status
Significant change in psychosocial needs
Concurrent poor nutritional status, unmanaged
anemia, and inadequate dialysis
Facilities need to have a method of classifying
patients
494.80: Patient Assessment
- Current health status
- Appropriateness of
dialysis prescription
- BP and fluid
management
- Laboratory tests
- Immunization and
medications
- Family and support
- Physical activity
-
Anemia management
Renal bone disease
Nutritional status
Psychosocial needs
Dialysis access
Patient’s desired level
of participation in care
- Suitability for
transplant
494.80: Physical Assessment
• Caveats
– Emphasis is on TEAM – everyone working
together – patient included
– Interdisciplinary is different from
multidisciplinary: more collaborative, more
congruent
– Policies and procedures are fine – they need to
be operationalized.
– Breakout session this afternoon will look at
ways in which providers are making this work
in real life.
494.90: Patient Plan of Care
• Interdisciplinary team involvement – at a
minimum:
–
–
–
–
–
–
Patient or patient’s designee
Registered nurse
Patient’s nephrologist
Social worker
Dietitian
Be signed by all team members, including the
patient or designee
494.90: Patient Plan of Care
• Implementation must begin within 30 days
or 13 treatment of initiation of dialysis
• Implementation of monthly or annual
updates to the plan must be performed
within 15 days of the completion of
additional assessments or reassessment.
494.90: Patient Plan of Care
• Dose of dialysis
• Meet and sustain Kt/V
of 1.2 (HD) or 1.7 (PD)
• Nutritional status
• Mineral metabolism
• Anemia
• Home assessment for
home patients
• Response to ESAs
• Vascular access type
• Vascular access
monitoring
• Psychosocial status
• Modality
• Transplant status
• Rehab status
494.90: Patient Plan of Care
• What QOL tool is recommended?
– CPM to be implemented in 2009 calls for
KDQOL
– The CrownWeb system will require KDQOL
domains to be entered.
– So…
494.90: Patient Plan of Care
• Additional points to remember
– If expected outcome for any area is not
achieved and sustained
• Documentation of revision for that portion of the
POC and QI process
– Nephrologist visits required monthly
• Can be Advanced practice RN or physician assistant
– Transplant referral tracking
• Workup process
• Waitlist tracking
494.90: Patient Care Planning
• Patient education
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–
–
–
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Dialysis experience
Dialysis management
Infection control
Home dialysis and self dialysis
Quality of life, rehabilitation
Transplantation
Vascular access
494.100: Care at Home
• New as a Condition
• Home dialysis services must be at least equal
to that provided for in-center patients
• Interdisciplinary team oversees training
• Be conducted by a registered nurse who
meets qualifications
• Specific areas to be covered in the training
494.100: Care at Home
• Periodic monitoring of home adaptation
including home visits
• Assessment and care planning same as for
in-center patients
• Meet specific water and dialysate testing
requirements – refer to conditions for
specifics
• Planning for back-up services
494.110: Quality Assessment and
Performance Improvement
“The facility must develop, implement,
maintain, and evaluate an effective, data
driven, quality assessment and
performance improvement program with
participation by the professional members
of the interdisciplinary team.”
494.110: Quality Assessment and
Performance Improvement
• Facility-wide – all services must be included
– In-center hemodialysis
– Home hemodialysis
– Peritoneal dialysis
– Reprocessing
– Water quality
…Just to mention a few…
494.110: Quality Assessment and
Performance Improvement
• Use of professionally accepted clinical
practice guidelines to track health
outcomes
• Identification, prevention, and reduction of
medical errors
• Action towards improving outcomes not
meeting target levels
• Patient satisfaction is included – CAHPS
tool is recommended by CMS
494.110: Quality Assessment and
Performance Improvement
• Use of principles of CQI
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Monitor data/information
Prioritize areas for improvement
Determining potential root causes
Developing, implementing, evaluating, and
revising plans that will result in improvements
in care
494.110: Quality Assessment and
Performance Improvement
• Adequacy of dialysis
• Nutritional status
• Bone and mineral
metabolism
• Anemia management
• Vascular access
• Medical errors
• Hemodialyzer reuse
• Patient satisfaction
and grievances
• Infection control
including surveillance
and immunization
status
Measures Assessment Tool
Subpart D
Administration
494.140: Personnel Qualifications
• Registered nurse
– Nurse manager
• RN, full time, 12 months nursing + 6 months dialysis
– Home training nurse
• RN, 12 months nursing + 3 months in home therapy
– Charge nurse
• RN, LPN/LVN, 12 months nursing including 3 months
dialysis
– Staff nurse
• RN, LPN/LVN
494.140: Personnel Qualifications
• Dietitian
– Must now have 1 year experience clinical
experience AFTER registration
• Social Worker
– Has not changed but there are more specific
directions as to the educational preparation
– Council of Social Work Education
www. cswe.org
494.140: Personnel Qualifications
• Patient Care Technicians
– High school diploma
– Completed formal training program
• Facility-based or college based
– Obtain certification
• National approved program (there are 3)
• State certification programs if
– Curricula meets regs
– Standardized test
– Proctored exam not given by dialysis facility
Patient Care Technicians
• Formalized training program
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Written program
Approved by medical director
Under the direction of a registered nurse
Meets specific components of the dialysis
procedure and patient care
– Demonstrated competency
• Written exam
• Skills validation
Patient Care Technicians
• National certification
– Current PCTs – by 4/15/2010
– Newly hired PCTs after 10/14/2008 – 18
months after hire date
– Nationally accepted program
• Nephrology Nursing Certification Commission
• Board of Nephrology Examiners for Nursing and
Technology
• National Nephrology Certification Organization
Patient Care Technicians
• FAQs:
– PCTs with > 4 years experience with NO high school
diploma may use work experience in lieu of diploma
– Non-certified PCTs must complete formal training
program before independently providing care
– PCTs with > 2years experience as of 10/14/08 do
not need to go through formalized training BUT
must demonstrate competency with test and skills
validation
494.150: Medical Director
Responsibilities
• Medical Director is specifically responsible for
the following:
– Quality assessment and performance improvement
program
– Staff education, training, and performance
– Policies and procedures
• All P/P related to patient care are adhered to
• Interdisciplinary team adheres to discharge/transfer
policies and procedures – including involuntary
discharge
494.180: Governance
• CEO/Administrator is responsible for
– Staff appointments
– Relationship with the ESRD Network
• Pursuing the goals and objectives of the Network –
including the electronic submission of data – Crown Web
– Allocation of staff resources for QAPI program
– Adequate staffing
– An RN is present in the facility at all times when
patients are being treated
494.180: Governance
• Internal Grievance Process
– Also addressed under Patient Rights
– Clearly defined procedure including time
frames
– Processes for communicating with the patient
– Those complaints or grievances that involve
patient safety must be addressed immediately
494.180: Governance
• Involuntary Discharge
– The medical director assures that no patient is
discharged or transferred from the facility
except for the following reasons:
• Failure to pay for ordered services
• The facility ceases to operate
• The transfer is necessary for the patient’s welfare
because the facility can no longer meet the
patient’s documented medical needs
OR
Involuntary Discharge
• The facility has reassessed the patient and
determined that the patient’s behavior is
disruptive and abusive to the extent that
the delivery of care to the patient or the
ability of the facility to operate effectively
is seriously impaired.
Involuntary Discharge
• The Medical Director ensures that the
interdisciplinary team
1. Documents the reassessment and on-going
problems
2. Provides the patient and ESRD Network with
30 day notice
3. Obtains a written order from patient’s
physician and the medical director
Involuntary Discharge
4. Makes contact with at least one other facility and
attempts to place the patient there
5. Notifies the State Survey Agency of the discharge
And…
Document, Document, Document
Involuntary Discharge
• In the event of immediate severe threats to
the health and safety of others, the facility
may use an abbreviated involuntary
discharge procedure
– Threat of physical harm
– Calling 911 or otherwise seeking police
involvement
– After emergency is addressed, medical director
and patient physician are notified as well as
Network and State Agency
Involuntary Discharge
• Interpretive Guidelines strongly suggest the
use of the Decreasing Dialysis Patient
Provider (DPC) tools to proactively address
conflict in the dialysis facility.
494.180 Governance
• Electronic forms submission for the ESRD
program administration
– Working with ESRD Networks in the Crown
Web process
• February 1, 2009 process will begin for ESRD forms
• 2728 Medical Evidence Form
• 2746 Death form
• Clinical Performance Measures
• Cost report and Administrative data
494.180: Governance
• Relationship with the ESRD Network
– Improve the quality and safety of dialysis related services
– Improve independence, quality of life, and rehabilitation
through encouragement of transplant, self care dialysis,
and home dialysis therapies
– Encourage and support collaborative activities to achieve
goals through the most efficient and effective means
possible
– Improve collection, reliability, timeliness of data to
measure processes of care, maintain the patient registry,
and support the ESRD Network program
Implementation of the
Conditions:
Moving from paper to practice
Where Do I Start?
• Get to know your regulations
– What is new and will have an effect on the
day-to-day operation on the dialysis unit?
• Ask the questions
– How do we put this into practice?
– What changes need to be made?
• Develop the policy/procedure
• Put it into practice!
How am I going to get everything
done?
• Creative thinking
– What is the best way to make this work?
• Ground up – Bottom down
– Supportive leadership
– The best ideas come from those who are
closest to the work
• Use the team
– Delegate, delegate, delegate!
The Goal is…
• Safe
• Effective
• Patient Centered
• Timely
• Equitable
• Efficient
• The Right care
for every
patient every
time
Important Links
• Conditions
http://www.cms.hhs.gov/CFCsAndCoPs/13_ESRD.asp#TopOfPage
• Interpretive Guidelines
http://www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCletter08-31.pdf
• ANNA/NKF Comprehensive Assessment Form
http://www.annanurse.org/download/reference/health/cmpa.pdf
Thank you!!
Questions?
[email protected]