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What is New at The Net? The New Conditions For Coverage – Changes For Clinical Staff. Lana Kacherova & Patrick Ciriello, ESRD Network 18 Clinical Issues in Nephrology October 19, 2008. Number of Prevalent ESRD Patients in the US. Network 18 Patient Distribution by Modality.
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What is New at The Net? The New Conditions For Coverage – Changes For Clinical Staff Lana Kacherova & Patrick Ciriello, ESRD Network 18 Clinical Issues in Nephrology October 19, 2008
Network 18 Mission Statement To provide leadership and assistance to renal dialysis and transplant facilities in a manner that supports continuous improvement in patient care, outcomes, safety and satisfaction.
Special Thanks for the Content Contribution to the CMS Transition Team Glenda Payne, Judith KariTeri Spencer, Kelly FrankRosemary Miller, Bonnie GreenspanBeth Witten
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
CMS Expectations for State Oversight of ESRD Facilities • Conduct initial surveys as soon as scheduling allows; Tier 3 workload • Conduct resurveys, FY 2009 • Tier 2: 10%; must be from top 20% of outcomes list • Tier 3: 30%; 4 year interval maximum • Tier 4: 33%; 3 year interval average • Conduct complaint surveys • When warranted • Within specified timeframes
ESRD Survey Focus: Protect Patient Safety & Improve Patient Outcomes • Data is used to focus surveys • During survey, observations focus on identification of safety hazards • Water/dialysate • Reuse • Machine operation/maintenance • Direct care • IDT assessment, planning & delivery of care
Condition 494.30: Infection Control(V110-V148) Must report problems to Medical Director and QAPI From One tag to whole Condition Infection Control regulations – apply to both chronic in-center dialysis & home dialysis programs Incorporated CDC documents: RR-05: Recommendations for Preventing Transmission of Infections Among Chronic HD patients RR-10: Guidelines for the Prevention of Intravascular Catheter-Related Infections Must report problems to Medical Director and QAPI
Environment/IC Program Sanitary environment in the dialysis facility & between the unit & other areas (V111) Components of an infection control program (V112)
Gloves & Hand Hygiene “Hand washing is the most important measure to prevent contaminant transmission.”--CDC V113 requires: Wear gloves – Whenever caring for a patient or touching the patient’s equipment. Remove/change gloves – Must perform hand hygiene after removal of gloves between each patient or station.
Gloves & Hand Hygiene Hand hygiene Use soap & water or alcohol-based antiseptic hand rub Visibly soiled vs. not visibly soiled Intravascular catheters Staff should wear clean or sterile gloves when changing the dressing on IV catheters Hand hygiene performed before & after palpating catheter insertion sites, as well as before & after accessing or dressing an IV catheter
Sinks with Warm Water & Soap V114 Requires: Sinks must be available & easily accessible to facilitate hand washing Includes in the patient treatment area, reuse room, medication area, home training room, & isolation area/room Sinks must be supplied with both hot & cold water Uncontaminated supply of paper towels available Expect: Dedicated hand washing sinks Designated utility sinks Sink available for patients to wash hands & access sites
PPE: Must Wear Gowns V115 requires: A gown or lab coat must be worn when the spurting or spattering of blood, body fluids, potentially-contaminated substances or chemicals might occur Aprons are not sufficient PPE during procedures that may result in the spurting or spattering of blood Clarifies when staff, patients, & visitors should wear PPE & when the PPE should be changed
Items Taken Into the Dialysis Station V116 requires: Items taken into the dialysis station Dispose, dedicate, or clean & disinfect Unused supplies or medications should not be returned to a common area or used on other patients
Clean/Dirty Areas & Medication Preparation Areas V117 requires: Separate clean from contaminated areas Prepare individual patient meds in a centralized area away from the treatment area Designate area only for medication prep Deliver separately to each patient Do not move the medication cart from patient station to patient station to deliver medications If trays are used, clean between patients
Single Use Vials = Single Use V118 requires: Single dose vials cannot be punctured more than once Must be used for only one patient Not entered more than once If entered, may not be stored for future use. BRAND NEW: MMWR August 15, 2008 retracts the 2002 CDC communication allowing multiple use of single use vials Multi-use vials: residual medication from two or more vials must not be pooled into a single vial
Supply Cart & Supplies V119 requires: If a common supply cart is used, do not move the cart from patient station to patient station to deliver supplies Do not carry supplies, patient care items, or medications in pockets
Transducer Protectors V120 requires: External venous & arterial pressure transducer filters/protectors Use for each patient treatment Change between each patient Change if it becomes “wet” If the external transducer protector becomes wet Replace immediately & inspect If fluid visible, qualified personnel must inspect inside of the dialysis machine after that patient treatment If contaminated occurred, machine must be taken out of service & disinfected
Handling Infectious Waste V121 requires: Handling, storage, & disposal of potentially infectious waste infectious waste Be aware of your State & local laws
Cleaning & Disinfecting of Contaminated Surfaces, Medical Devices, & Equipment V122 requires: Protocols for cleaning & disinfecting surfaces & equipment Manufacturer’s DFUs followed CDC recommended disinfection procedures Cleaning & disinfection of environmental surfaces completed between patient uses Chairs, beds, machines & containers associated with prime waste, adjacent tables & work surfaces
Cleaning & Disinfecting of Contaminated Surfaces, Medical Devices, & Equipment V122 requires: Clean & disinfect medical devices & equipment after each patient Scissors, hemostats, clamps, stethoscopes, blood pressure cuffs Blood spills cleaned effectively & immediately “Intermediate-level” disinfectant
Hepatitis B Routine Testing, Vaccination, Screening, & Seroconversion (V124-127) Routine testing for HBV (V124) HBV status of all patients known before admission to the HD unit Test all patients as required by the CDC schedule Results of HBV testing promptly reviewed (V125) Vaccination of susceptible patients & staff members (V126) All susceptible patients & staff are offered hepatitis B vaccination
Hepatitis B Routine Testing, Vaccination, Screening, & Seroconversion Test for response to the Hepatitis B vaccine (V127) Seroconversion (V125) Reported to the State or local health department Isolation of the seroconverted patient Review all patients’ lab test results for seroconversion
HBV+ Isolation Room/Area V128 & V129: Isolation of HBV+ Patients Effective Feb 9, 2009, every new facility MUST include an isolation room for treatment of HBV+ patients, unless the facility is granted a waiver of this requirement For existing units in which a separate room is not possible, there must be a separate area for HBsAg positive patients
Isolation of HBV+ Patients Dedicated machines, equipment, supplies, & medications (V130) Used only for HBV+ patients until patient is discharged from facility Staff assigned to care for HBV+ patient (V131): May only care for other HBV+ patients or HBV immune patients
Staff Training & Education V132 Infection Control Training & Education Required for both new & existing staff members V147 Education & training for care of IV catheters
Oversight for Infection Control Practices/ Program & Reporting Requirements Biohazard & infection control policies & activities (V142) Compliance with current aseptic techniques in IV medication dispensing & administration (V143) Reporting of infection control issues to the medical director & QAPI committee (V144) Reporting communicable diseases (V145)
IV Catheter Care & Maintenance V146-148 Adopts RR-10 CDC recommendations related to catheters as regulation (V146) Monitor catheter sites (V147) Conduct surveillance for catheter related infections (V148)
Major Change: No LTP (Long-Term Plan) 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
A New Day… • The new CfCs of Patient Assessment & Plan of Care require defined Standards • The new CfCs use Standards developed by the ESRD community • Surveyorshave a fabulous tool for reference of these Standards in the MAT (Measures Assessment Tool) • If an individual patient does not meet a goal on the MAT, expect to see revised plan for that aspect
The Interdisciplinary Team (IDT) Includes at a minimum: • The patient or their designee (if the patient chooses) • A registered nurse • A physician treating the patient for ESRD • A social worker • A dietitian
Patient Assessment (V501) and Patient Plan of Care (V541) These 2 Conditions: • Are interrelated (“can’t have one without the other”) • Address patient assessment & care delivery requirements in “care areas” associated with complications of ESRD
§ 494.80 Patient Assessment • The IDT must provide each patient an individualized comprehensive assessment (V501) • 14 assessment “criteria” (V502-515) • Reassessments at defined frequencies (V516-520)
§ 494.90 Patient Plan of Care (V541) • The IDT must develop & implement a written, individualized comprehensive patient plan of care (POC) • POC based upon the comprehensive assessment • Addresses each patient’s care needs • Outcome goals in accordance with clinical practice standards
Patient Assessment & Patient Plan of Care • Consolidated into “care areas” for discussion • Each will include: • Patient assessment requirements • Plan of care: use of the MAT • How to survey • What to review in the medical record for implementation
Health Status and Co-morbid Conditions Assessment What is expected: (V502) • Use of medical & nursing histories and physical exams • APRN or PA may conduct medical areas of assessment as allowed by states • Must include etiology of kidney disease and listing of co-morbid conditions
Dialysis Access: Assessment What is expected: (V511) IDT comprehensive assessment: • Expect assessment for most appropriate access for the patient: AVF, graft, CVC, PD catheter • Consider co-morbid conditions/risk factors, patient preference • The efficacy of HD & PD patient’s access correlates to adequacy of dialysis treatments
Dialysis Access: Assessment What is expected: (V511) IDT evaluation may include: • Evaluation for/of HD access: • Communication with radiologist, interventionist, vascular surgeon • Venous mapping, vascular access surveillance, new access placement • Evaluation of PD access • Absence of infection (exit site/tunnel, peritonitis) • Patency & function
Dialysis Access: POC What is expected: (V550) IDT comprehensive plan shows evidence of: • Patient evaluation as candidate for AVF • If CVC >90 days, action plan for a more permanent vascular access • Location of patient access to preserve future sites, for long term patient survival • Monitoring to ensure capacity to achieve & sustain adequate dialysis treatments
Dialysis Access: POC What is expected: (V551) IDT comprehensive plan shows evidence of: • Vascular access surveillance • Early detection of failure • Timely referrals for interventions • Medical record documentation of the action taken
Adequacy: Assessment What is expected: (V518) IDT comprehensive assessment includes: • HD patient- initially & monthly Kt/V (or equivalent measure, URR) • PD patient- initially & at least every 4 months Kt/V (or equivalent measure, none currently)
Adequacy: POC What is expected: V544 POC Demonstrates: • Achievement of target: Kt/V of at least 1.2 (3 x/week HD) or 1.7 (PD) • Alternative equivalent (URR), currently none for PD, OR