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Interpretative Guidance Development and Implementation of the CfC. Judith Kari, CMS National Technical Director Glenda Payne, CMS Technical Advisor, RO 4 & 6. Objectives. Describe major changes to the Conditions for Coverage

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interpretative guidance development and implementation of the cfc

Interpretative Guidance Development and Implementation of the CfC

Judith Kari,

CMS National Technical Director

Glenda Payne,

CMS Technical Advisor, RO 4 & 6

objectives
Objectives
  • Describe major changes to the Conditions for Coverage
  • Discuss the challenges of preparing for and implementing the new regulations
  • Demonstrate understanding of the most frequently cited deficiencies at this point and what Networks may do to help facilities be more ready for surveys
major changes to regulations
Major Changes to Regulations

Subpart A: General

1. Compliance with Federal State & local laws and regulations

Subpart B: Patient Safety

2. Infection control

3. Water and dialysate quality

4. Reuse of hemodialyzers

5. Physical environment

subpart c patient care
Subpart C: Patient Care

6. Patients’ rights

7. Patient assessment

8. Patient plan of care

9. Care at home

10. QAPI

11. Special purpose dialysis facilities

12. Laboratory services

subpart d administration
Subpart D: Administration

13. Personnel qualifications

14. Responsibilities of the medical director

15. Medical records

16. Governance

No More "Subpart U"

preparing for implementation development of the interpretative guidance
Preparing for Implementation: Development of the Interpretative Guidance
  • Community involvement
    • Draft document to listserv of 10K+ stakeholders
    • Community Forum (120 attended)
    • Revised draft to listserv
      • 1600 comments received and reviewed; used to craft final document
  • Evolutionary process
    • Began with a focus of surveyor guidance
    • Community feedback wanted more
    • Evolved in a broader way to address needs of community as well as the needs of surveyors
development of the interpretative guidance
Development of the Interpretative Guidance
  • Focus on defining terms for clarity
    • Aim to ensure consistent interpretation by providers and surveyors
  • Involvement of CDC / AAMI
    • Active on-going dialog with CDC
    • Repeated review of the Water & Dialysate portion by the AAMI RD Committee
  • Survey Process separate
    • Developing specific process guides for initial and resurveys
    • Directed at the needs of the surveyors
    • Will be part of the State Operations Manual
development of the interpretative guidance measures assessment tool mat
Development of the Interpretative Guidance: Measures Assessment Tool (MAT)
  • Community based standards in an easily updated tool
  • Presented as part of the IG
  • Used by surveyors in reviewing PA/POC and QAPI
  • Issue: whether requirement for use of the CAHPS survey instrument should be reconsidered?
the waivers
The Waivers
  • New Facility: Isolation Room
    • Based on distance and travel time to a facility with isolation capacity and willingness to accept patients
  • Qualifications of the Medical Director
    • Time limited, potentially renewable
    • Based on outcomes list
  • Life Safety Code
    • If compliance presents an unreasonable hardship
    • If the waivered requirement will not present a risk to patient safety
phased in time extensions
Phased-In Time Extensions
  • Single-Use Vials (end of June, 2009)
  • Water Storage Tanks (dependent on water cultures)
  • Interdisciplinary Patient Assessment (October 14, 2009)
  • CROWNWeb Data Submission (phased-in time line)
education surveyors and community
Education: Surveyors and Community
  • April 2008: NKF and ANNA National meetings (~500 providers)
  • Sept 2008: Update focused on new regs (~325 surveyors, providers, & NW staff)
  • Basic ESRD Training: 3 completed, based on new survey process and new regs (~130 surveyors)
  • STAR: updated to new regs: more comprehensive update in process
education surveyors and community12
Education: Surveyors and Community

Community outreach:

  • ANNA Web-ex: over 100 chapters nation-wide participated (~1500 providers)
  • NKF Coffee house conversations with patients: ESRD Support Team has participated in (three) of these hour long phone conferences; (>100 attendance at each)
  • Local, state and national presentations for ANNA, NKF, NANT, DaVita, various Networks
on going work of implementation
On-going Work of Implementation

Survey & Certification Letters

  • 09-01: Interpretative Guidance
  • 09-13: Waivers & Phased-in Requirements
  • 09-24: LSC

Administrative Information Letters

  • 09-16: CROWNWeb Phased-in Requirement

For S&C letters:

http://www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR/list.asp

Click on "Show only," then click the box "Show only items containing the following word" (type the S&C memo number in the field), and then click the button "Show Items."  The database should find the S&C memo you want.

on going work of implementation14
On-going Work of Implementation

State Operations Manual

  • Under construction
  • Will include Survey process for initials and resurvey
  • Will address survey and certification issues (e.g., adding services or stations; relocations; temporary closures, centralized reprocessing)
on going work of implementation15
On-going Work of Implementation

Implementation of LSC plan:

  • LSC survey required for all initial surveys effective 2/9/09
  • LSC surveys for complaint allegations related to LSC requirements
  • A % of resurveys will include LSC after the ASPEN system is updated with the LSC K-tags for ESRD (Summer, 2009)
condition level citations
Condition Level Citations
  • Infection Control
  • Water & Dialysate Quality
  • Governance
  • QAPI
  • Responsibilities of the Medical Director
  • Patient Plan of Care
  • Physical Environment
most frequently cited deficiencies
Most Frequently Cited Deficiencies

Infection Control

  • Clean & Disinfect surfaces
  • Wear gloves/hand hygiene
  • Items taken to station: D/D/D
  • Clean/dirty areas; med prep area
  • Wear gowns/PPE
infection control why would this be cited
Infection Control: Why Would This Be Cited?

All about

  • HANDS
  • Supplies
  • Meds
    • Saline
    • Heparin
  • PPE
most frequently cited deficiencies20
Most Frequently Cited Deficiencies
  • PA/POC
    • Assess B/P & fluid mgmt needs
    • Manage volume status
  • Medical Director Responsibilities
    • Ensure all adhere to P&P
  • Physical Environment
    • PM; follow manufacturer’s DFU
patient assessment assess b p and fluid management needs
Patient Assessment: Assess B/P And Fluid Management Needs

Why would this be cited?

  • Review of flow sheets = no evidence B/P is being monitored
  • Post weight does not = goal and no comment is made
  • Fluid removed and weights do not match and no comment is made

Note: Surveyors are being taught to look at flow sheets for the implementation of the assessment-based plan of care

md resp all adhere to p p
MD Resp: All Adhere To P&P

Why would this be cited?

Admission policies

  • Orders
  • Baseline H&P
  • Nursing assessment prior to 1st treatment
  • “Adhere to P&P”
pe equipment maintenance follow dfu
PE: Equipment Maintenance; Follow DFU

Why would this be cited?

Equipment Repair & Maintenance

Follow the DFU*

*DFU= Directions for use

another word about pa poc
Another Word about PA/POC

Here is a REAL opportunity to CHANGE the way care is delivered!

Here is a REAL opportunity to:

  • INCREASE patient involvement and
  • INCREASE patient independence

= Improved Satisfaction & Better Working Conditions For Everyone!

how is this supposed to work
How Is This Supposed to Work?
  • PA: identifies intradialytic weight gains (IDWG) of greater than 12 pounds/treatment
  • POC:
    • IDT members (all) to work with patient on risks of excessive fluid gains and (RD) on ways to handle thirst
    • Agree to a goal for IDWG to be reduced by 10% each week until goal of no greater than 5 pounds is reached
    • Monitor IDWG each treatment. Praise positive actions (RN, PCT)
    • If IDWG remains at same levels at end of one month, review and revise POC
your help is needed
Your Help Is Needed!
  • Please post survey tools on your websites
  • Continue to provide educational opportunities for providers
your help is needed29
Your Help Is Needed!
  • Promote consistent interpretation: if unsure, ask:

ESRDsurvey@cms.hhs.gov

your help is needed30
Your Help Is Needed!

Educate providers: PA/POC:

Here is a REAL opportunity to CHANGE the way care is delivered!

Here is a REAL opportunity to:

  • INCREASE patient involvement and
  • INCREASE patient independence

= Improved Satisfaction & Better Working Conditions For Everyone!

Encourage making this work worthwhile—it is so not about paper or the form!

your help is needed31
Your Help Is Needed

Educate providers: QAPI

  • Lots of opportunity for improvement
  • Need “real world” examples and encouragement to develop skills
questions

Questions?

ESRDsurvey@cms.hhs.gov