Transition to Surveys with New ESRD Regulations What Does the Future Hold? 1

Objectives Demonstrate understanding of the background & rationale for changes to the current ESRD regulations Describe the implementation challenges for surveyors & facilities Discuss major changes from the current to the new regulations 2 2

The Long Journey 3

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 To First, paper reviews First, safety reviews Water Reuse Infection control Physical environment Structure Outcomes 5

1994: Change in the Survey Process From a focus on: To a focus on: Policies Procedures Personnel records Reviewing data Observing care Interviewing patients Interviewing the people doing the work As work continued on the revision of the ESRD regulations, the survey process was changed 6

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 As work continued on the revision of the ESRD regulations, the survey process was changed 7

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 8

Rationale Behind the Changes 9

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 (aka, Pay for Performance) Necessary if CMS moves to bundled reimbursement for ESRD care 10 10

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 11 11

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 12 12

Final ESRD Regulations Finally Published! POSTED April 3, 2008 13 13

Targeted “Publish” Date: April 15 Posted for Viewing http://www.cms.hhs.gov/CFCs AndCoPs/downloads/ESRD displayfinalrule.pdf (In Word = 625 pages) Targeted “Publish” Date: April 15

The Implementation Begins 14

What are the Effective Dates for these Rules? New Conditions for Coverage 6 months 10-14-08 Life Safety Code and Separate room for HBsAg+ patients 300 days 2-9-09 Certification of technicians hired after 10-4-08 18 months from hire Certification of existing technicians 24 months 4-15-10 15

New Rules Require New Data Infrastructures The Survey & Certification data system, ASPEN, must be updated The automated ESRD data software, STAR, must be updated 16

New Rules Require New Interpretive Guidance Interpretive Guidance (IG) is CMS’ interpretation of the Rule ; provides clarification to surveyors & providers Community input was sought for this guidance: Draft document posted on the web & emailed to 10,000 CMS listserv subscribers Community Forum in December 2007 for patients, professionals (all disciplines), providers, suppliers, organizations 17

Interpretive Guidelines Thanks for Your Help! 18 19

Implementation Challenges: Surveyors & Facilities Effective Date? 10-14-2008 Lots of time? NOT Federal Register April 15, 2008 19 20

New Rules Require New & Updated Products New Survey Protocol New training courses & training materials Updated Frequently Asked Questions Updated STAR (automated ESRD survey process) Updated communications websites 20

Implementation for Facilities Read the whole document (preamble & rule) Review current practice (& policies) to be sure they meet rules Identify staffing, practice, equipment, & training needs Develop documentation tools to match the new rules (logs, audit tools, chart forms) 21 22

What are some of the major changes? 22 23

Infection Control From one tag to a Whole Condition Adopts CDC’s 2001 Recommendations for Prevention of Infections in Hemodialysis CDC’s 2002 Guidelines for the Prevention of Catheter-Related Infections Okay, enough already! What is really in there?? 23 24

Infection Control Hepatitis All new facilities must have a separate room Must report issues to Medical Director & QAPI Okay, enough already! What is really in there?? 24 25

Adopts AAMI RD52:2004 as regulation Written for the user Water & Dialysate Adopts AAMI RD52:2004 as regulation Written for the user Specifics & required monitoring detailed for all water treatment components Separate requirements for water treatment for home hemo under Care at Home Condition 25 26

Dialysate For the first time, specific regulations for dialysate AAMI RD52:2004 addresses acid & bicarbonate concentrate: Labeling Mixing Distribution Use 26 27

From ~8 tags to about 175 tags! Very detailed & thorough Water & Dialysate From ~8 tags to about 175 tags! Very detailed & thorough Most questions will now have a regulatory answer Use RD52:2004 to update facility policy & practice for water treatment & dialysate preparation & distribution 27 28

Reuse Adopts AAMI RD:47:2002/2003 Requires reuse be suspended if a cluster of adverse patient reactions is associated with reuse 28

Physical Environment Life Safety Code (LSC) Requirements: Must meet provisions of NFPA 2000 Grandfather clause for current facilities in non-sprinklered buildings if built prior to 1/1/2008 State fire safety codes may be used in lieu of LSC Specific provisions of LSC may be waived in some cases 29

Physical Environment Every facility must have an AED or a defibrillator (& ACLS qualified staff) All equipment maintained & operated according to manufacturer’s directions Emergency preparedness for staff & patients, including disaster prep—get to know your local Emergency Ops Center 30

Patients’ Rights To be treated with respect & dignity and to: Receive information on all modalities, including those not provided at the current facility Receive alternative scheduling options [from other facilities] for working patients Receive necessary services listed in the Plan of Care 31

Be informed of the right to have an advance directive Patients’ Rights Be informed of the right to have an advance directive Be informed about transfer & discharge policies 32

Patient Assessment Comprehensive Interdisciplinary team Initial completed within the latter of 30 days or 13 HD treatments Components required include anemia, adequacy, access, bone disease, nutrition, psychosocial status, home dialysis, transplant status, functional status, rehab FYI: ANNA/NKF have developed a tool 33

Stable patients require annual review Patient Assessment Comprehensive reassessment within 3 months of completion of the initial assessment for all patients Adequacy assessed monthly for HD; every 3 months for PD Stable patients require annual review 34

Patient Assessment Assessments and plan of care done monthly for “unstable patients,” examples include: Extended or frequent hospitalizations; Marked deterioration in health status; Significant change in psychosocial needs; or Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. 35

Plan of Care No “cookie-cutter” approach allowed Must address identified needs = individualized! Initial: within 30 days or 13 outpatient hemodialysis treatments of admission Update: within 15 days of each re-assessment 36 37

Major Change: No LTP No expectation for a long term program or “signature” of transplant surgeon Requirements for patients to be informed of all modalities (transplant & therapies not offered at their current clinic) are addressed under: Patients’ Rights Patient Assessment Plan of Care 37 38

Care at Home Separate Condition for home therapies Care at home must be equal in quality to care provided in-center Training required for patient described in detail Water treatment / dialysate separately addressed, including newer technologies 38 39

Home Dialysis in Residential Institutions Interim: home dialysis in residential institutions will be addressed in Survey & Certification Letter Long-Term: future rules will address this area 39

QAPI Condition level Interdisciplinary team Process continuous & on-going Outcome focused: use community accepted standards as targets Include patient satisfaction, infection control, medical injuries & medication errors Plan/Do/Check/Act: Close the loop! Plan Do Check Act= PDCA 40 41

Special Purpose Renal Dialysis Facilities For Vacation camps Facilities providing services in emergencies Approved for a maximum of 8 months 41

Laboratory Services Dialysis facility must provide or make available appropriate lab services Lab services must meet CLIA regulations 42

Personnel Defines individual qualifications: Medical Director Nurses: nurse manager, home training nurse, charge nurse, staff nurse Dietitian Social Worker Defines group qualifications: Patient care technicians Water treatment system technicians 43

Personnel Patient Care Technician High school diploma or equivalency Complete a (defined) training course, approved by Medical Director & Governing Body; under direction of RN Be certified by a State or national program New employees: within 18 months of hire date (starts after 10/4/08) Current employees: within 24 months of 4/4/08 44

Medical Director Accountable to the Governing Body Responsible for patient care and outcomes Responsible for effective QAPI and Infection Control programs Must actively participate in the QAPI program—and if QAPI Condition is out of compliance, so is the Condition of Medical Director. Facility governing bodies and medical director need to consider what mechanisms they will need to have in place to achieve this—if an attending physician refuses to follow policy regarding the care planning process—what action can the Medical Director take? If staff members don’t follow policy regarding monitoring of patient during treatment, are those issues brought to the Medical Director for his attention? She/he will be expected to be responsible for non-adherence of staff and physicians and non-physician providers practicing in the dialysis facility. The medical director must co-sign any order for involuntary patient transfer or discharge 45 46

Medical Director Responsible to assure all staff, physicians & non-physician providers “adhere” to all policies Must be engaged in any involuntary patient transfer or discharge Must actively participate in the QAPI program—and if QAPI Condition is out of compliance, so is the Condition of Medical Director. Facility governing bodies and medical director need to consider what mechanisms they will need to have in place to achieve this—if an attending physician refuses to follow policy regarding the care planning process—what action can the Medical Director take? If staff members don’t follow policy regarding monitoring of patient during treatment, are those issues brought to the Medical Director for his attention? She/he will be expected to be responsible for non-adherence of staff and physicians and non-physician providers practicing in the dialysis facility. The medical director must co-sign any order for involuntary patient transfer or discharge 45 47

Medical Records Traditional rules on completeness & protection of medical records Transfer requested records to the receiving facility within one day 46

Governance: RN Presence “An RN, who is responsible for the nursing care provided, is present in the facility at all times that in-center dialysis patients are being treated.” 47

Governance: Patient Involuntary Discharge Specific requirements Reassess the patient Involve the Medical Director Contact another facility and attempt to place 30 days notice unless threat to safety Notify the Network and the State Agency FYI: Network “DPC” program contains tools to help prevent involuntary discharges 48 50

Governance: Electronic Data Submission As of 2/1/09, every facility must electronically submit data on all patients, including data on clinical performance measures, to CMS. CROWN Web 49

What Does the Future Hold? Opportunity to improve patient outcomes and Lots of good work for you Lots of good work for us! 50

Thank You for... Partnering with CMS to enhance & inform the survey & certification work Providing data & outcomes to guide & direct our work Improving consistency by helping us build Interpretive Guidelines with common understandings 51

* Remember, the rules were only published Thursday… Questions?* * Remember, the rules were only published Thursday… posted 52

Helpful CMS Websites ESRD Open Door Forum listserv http://www.cms.hhs.govAboutWebsites/20EmailUpdates.asp ESRD Center http://www.cms.hhs.gov/center/esrd.asp 53 55