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Judith KariGlenda Payne & The Transition

Team

Using the ESRD Survey Process for the 2008 Conditions for Coverage

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Objectives of This Presentation

Describe the expectations & challenges of an ESRD survey

Recognize ESRD standards of care & how these are used by surveyors

Describe data available to ESRD surveyors & its use in ESRD surveys

Describe tasks to be used to conduct the new ESRD survey

Demonstrate understanding of use of findings in constructing DPS & findings for CMS 2567

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Spectrum of ESRD Services“ESRD benefit” & the ESRD CfC cover:Outpatient dialysis in ESRD facility

• In hospital (“hospital based”) or• Outside hospital (“independent”) or• Special purpose (for 8 months max.)

Training & support for home/self dialysis

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Hospital-Based Dialysis

Based on integrated ownership & operation

NOT…•LOCATION•Shared service agreement•Patient referral agreement

At CFR 413.174

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ESRD Benefit & the ESRD CfC Do NOT Cover

Dialysis in an inpatient settingAcute dialysis

(These are covered by hospital PPS & surveyed under Hospital COP)

Pre-ESRD: Stages 1-4 Chronic Kidney Disease (CKD)

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CMS Expectations for State Oversight of ESRD FacilitiesConduct initial surveys as soon as

scheduling allows; Tier 3 workloadConduct 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

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Challenges for ESRD SurveysSurveys are technically &

clinically complex: Not intuitiveEquipment & technologies keep

changing: Need updated information

Large number of V-tags: ~400Recognized Standards: Need

updated informationWorkload competition: Not

statutorily mandated

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ESRD Survey Focus: Protect Patient Safety & Improve Patient Outcomes

Data is used to focus surveysDuring survey, observations

focus on identification of safety hazards• Water/dialysate• Reuse• Machine operation/maintenance• Direct care• IDT assessment, planning &

delivery of care

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Direct Partners in Guidelines & Standards: Incorporated in RegulationsAAMI:

• RD52:2004 Dialysate for Hemodialysis• RD62:2001 Water for Hemodialysis• RD47:2002/03 Reuse of Hemodialyzers

CDC • RR-05: “Recommendations for Preventing

Transmission of Infections Among Chronic Hemodialysis Patients”

• RR-10: “Recommendations for Placement of Catheters in Adults and Children”

NFPA• 2000 Life Safety Code

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Partners in StandardsFDA

• Approval of devices, including manufacturer’s guidelines

• Reports on malfunctionsNKF

• Kidney Disease Outcomes Quality Initiative (KDOQI)

• Community-accepted guidelines for both “minimum” & “target” outcomes

NQF• Develop CPMs

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Partners for Reference Standards American Nephrology

Nurses’ Association (ANNA)•Standards for nursing care•Guidelines for care

Renal Physicians Association•Kidney Patient Safety website

State Practice Acts

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Surveyor Use of Standards & GuidelinesPOC: The implemented POC must

result in patient outcomes that meet minimum levels of defined standards• If “minimum” standards of care are not

met, there must be a change to the POC implemented

QAPI: For facility: Each facility must provide care to their (group of) patients that meets defined standards• If “minimum” standards are not met,

expect assessment of that aspect of the QAPI program

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Measures Assessment Tool (MAT)Developed to allow updating as

Standards changeIncludes both individual targets

for patients & aggregate targets for facility use in QAPI

Included as an addendum to the Interpretative Guidance

Laminate for ease of use

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The BASIC Survey Process

Used for recertificationOrganized around TASKSFocus of this session!

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The INITIAL Survey Process

Use the Basic survey process as the base for”

InitialsComplaintsRelocationsChange in service

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STAR: Automated ESRD Survey

Surveyor Technical Assistant for Renal Disease (STAR)

An automated survey guideUses a wireless tablet PCGuides YOU through the

survey processRoll-out in process

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STAR …

Automatically produces a draft of Form CMS-2567• Finds V-tags• Converts handwriting to typed text

Will be updated to the new CfC asap• Can still use STAR in the meantime• Use the crosswalk to convert findings

to new tags

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Pre-Survey Activities

Review of facility file• Problems, complaints• Previous surveys

Review of data • Outcomes List• Dialysis Facility Reports (DFRs)

Contact ESRD Network

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Using Data/Outcomes in ESRD SurveyPre-survey:

• Use Outcomes List to select facilities • Use Dialysis Facility Reports to plan

surveyDuring survey:

• Use data to focus survey• Expect QAPI action if poor outcomes

identifiedPost-survey:

• Data may define the citation level (i.e. standard, conditional, or Immediate Jeopardy)

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What Type of Data Is Available for Surveyors?

ESRD Dialysis Facility Reports and Outcomes List developed for States for survey purposes:http://

www.sph.umich.edu/kecc/usr/usr.htm ESRD DFRs distributed to each

state every September-October

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ESRD Data Reports for Surveys1. Outcomes List

•Rank-ordered list of facilities (#1 is the lowest-ranked facility)

•List is based on 3 factors: Adequacy of dialysis, anemia management & adjusted mortality rate

•There is a positive correlation between ranking on the outcomes list & survey deficiencies

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Clicker Question!!

My state uses the outcomes list to choose facilities for survey each year.1.Yes2.No3. I don’t know4. I don’t work for a state

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ESRD Data Reports for Surveys

2. Dialysis Facility Reports•Facility characteristics, patient

outcomes & practice patterns in the report

•Summary text on the first five pages: compares facility data to State, Network & national levels

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Clicker Question!!

I have easy access to the DFR for every survey.1.Yes2.No3. I don’t know4. I don’t work for a state

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ESRD Data Reports for Surveys 2. Dialysis Facility Reports

• Charts for the following: Standardized mortality rates (SMRs)

under 1.00 are better than average—the lower the better

Adequacy: Kt/V of 1.2 or greater is target

Hematocrit level 30-36% or hemoglobin level of 10-12 mg/dL are targets

• These data are COMPARATIVE—updated numbers from the facility may not be comparative

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Clicker Question!!

I routinely use the DFR for every survey.1.Yes2.No3. I don’t know4. I don’t work for a state

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Why Do Surveyors Use Data?To SELECT facilities to surveyTo FOCUS the survey process

onsite (look at current data, QAPI)

To DETERMINE the extent of noncompliance (enforcement)

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What Other ESRD Data Is Available?

CROWNWebDialysis Facility Compare (DFC):

facility-specific data for the public at www.medicare.gov/dialysis

Network data: annual reports & other data at www.esrdncc.org

United States Renal Data System (USRDS) Annual Report at www.usrds.org

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Coming Soon… CROWNWeb

New CfC requires all facilities to submit data electronically starting 2/1/09

Will provide data on 100% of patients from each facility

DFRs in future will reflect data from CROWNWeb

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Survey Tasks1. Pre-survey prep2. Introductions3. Tour/Observations4. Entrance

conference

5. Patient sample selection

6. Water treatment/ Dialysate preparation

7. Reprocessing/Reuse 8. Machine operation/

Maintenance

9. Home training dept review

10. Patient interviews11. Medical record

review12. Personnel interviews13. QAPI14. Personnel record

reviews15. Decision making16. Exit conference

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“Our Survey” Data Shows

DFR shows 76% of the patients have hematocrit (Hct) > 30% (State average = 89%)

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Surveying Is Like a Puzzle

It takes more than 1 piece to solve it

You may have a different view at the end than you did at the beginning!

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Task 2: Introductions

Is BRIEFIntroduces the members of

the team to the person in charge

Briefly explains the purpose of the survey

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Task 3: Tour/Observations

Ongoing throughout surveyPhysical environmentInfection controlPatient/staff interactionPatient care deliveryStaffingMedical records/logs in use

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Task 3a: Environmental Tour

3a: ”Flash survey” of all areas:Waiting roomPatient restroomsReuse roomWater /Dialysate areasHome training areaTreatment areaIsolation

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During the Tour

Is the environment safe & sanitary? (V111, 112, 122, 401, 402)

Free of hazards? (V401, 402) Are patients treated with respect?

(V452) Are machine alarms set &

responded to? (V402, 757)

(From your new laminate on the survey process)

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Task 3b: Observe Care

Infection control practicesPatient careDialysis machine & dialyzer

use

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Observe CareAre staff following CDC

recommendations & these regulations for prevention of transmission of infections? (V113, 115, 116, 117 & more!)

Are current records complete? (V726, 326)

Do staff respond to patient problems? (V543, 544, 546, 547, 549)

Is a Registered Nurse present? (V759)

Are trainees supervised? (V715, 760)

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3c: Emergency Equipment

Review for equipment function (V413)

Staff emergency preparedness (V409, 411)

Evacuation supplies present/in date (V408)

Fire extinguishers present (V417)

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“Our Survey” Data Collection

During observations on 10/19/08 at 9:30 a.m., 12 of 18 dialyzers from the first shift to be reprocessed are noted to be bright red

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Task 4: Entrance Conference

Purpose/ anticipated scheduleCMS 3427 to completeCollect facility specific info:

use STAR or worksheet & reference materials list

Request patient sampling info

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Task 4: Entrance Conference

Review the facility-specific data report with the manager

Ask for current data

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Task 5: Patient Sample Selection

10% sample (min=5; max=15)

Sample to include variety—all treatment modalities offered must be represented

Use info requested from facility to choose sample

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Sample Selection

Current patient census by modality, with admit dates

Current HD patient listing by shift (seating chart)

Cumulative lab reports Infection logs Hospitalization logs Vascular access information Any pediatric patients Residents of LTC facilities

“Our survey” sample would include some patients identified from cumulative lab reports as “challenges” for anemia management

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Task 6: Water Treatment & Dialysate Preparation6a-Observation/ InterviewTalk to the people doing the

work“Walk me through the water Required components:

• TWO carbon tanks; 10 min EBCT (V192, 195)

• RO (V199, 200) or DI (V202, 203) Observe chlorine /chloramine

testing (V196, 197, 270)

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Task 6b: Review Of Water Treatment Logs

Chemical analysis (V201, 206, 177)

Microbial surveillance: monthly CFU & EU (V213, 254); response to action levels (V178, 255)

Ch/chl testing (V196, 197, 270)Daily logs: hardness (V191); RO/DI

parameters (V199, 202)

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Task 6c: Review Of Dialysate Prep & DeliveryObserve mixing if possibleBatches mixed on site:

• Per DFU (V226)• Batch tested & verified (V229)• Bicarb not overmixed (V234)• Bicarb storage minimized (V233)

All containers labeled (V228) Outlets labeled/color coded (V245,

246, 247)Jugs: rinsed daily (V243),

disinfected weekly (V244)

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Task 7: ReuseTask 7a: Observations Of

Reprocessing Procedures/Interview With Reuse Personnel

Observe the entire reuse process:•Set up for use•Take down•Rinsing•Testing•Filling with germicide•Storage

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Task 7b: Review of Reuse Logs

Reprocessing logs (V326)Germicide vapor testing (V318)Cultures/ LAL (V205, 314)PM/repairs (V316); tested after

repairs (V317)QA: required audits done (V362-

368); reviewed in QAPI (V635)

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Task 7c: Centralized ReprocessingNote: Surveyor must review

tasks 7a & 7b at the centralized reprocessing location

P&P at user ESRD facility for transportation & clinical use (V306)

Safe transport of dialyzers (V331)

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“Our Survey” Data Collection (cont.)

During observation of reuse practices at 10:00 a.m. on 10/19/08, you see that 6 of the 12 dialyzers used by patients on the first shift are dark red when brought to the reprocessing area for rinsing & reprocessing. 3 of these belong to the patients you interviewed, & they rinsed clear.

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Task 10: Patient InterviewsTry for a minimum of 5 patientsCan be same sample as records

reviewed or differentDone in treatment area, waiting

room, in private, or by phoneUse a structured interview guide

—in STAR, our guide or “custom”

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Patient Interview Guide

Ask the following: How do you participate in

your Plan of Care?* (V541, 556) How does your dialyzer look

when your treatment is finished—clear, pink or red?**(V547)

(*=standard; **=custom)

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“Our Survey” Data Collection During patient interviews, 3

of 5 patients tell you their dialyzer is always red when their treatment is finished

These 3 patients (#s 2, 4 & 5) were interviewed 10/19/08 from 11:30 to 1:15

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Task 11: Medical Record ReviewReview 3-7 sampled records

completely; focus remaining reviews on identified concerns

Use STAR or the record review worksheet

New focus: patient assessment & POC development

Refer to the MAT for current standards; if not met for individual patient, expect to POC

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Task 11: Medical Record ReviewHow will we know the POC is

implemented?•Physician’s orders•Laboratory values•IDT progress notes •POC changes/ updates•Dialysis flowsheets

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Task 11: Medical Record Review Current tx

orders:• Time• Frequency• BFR/DFR• Dialyzer• Heparin dose• ESA? Dose?• Iron Rx?

Flow sheet:• Tx delivered as

Rx?• Freq of B/P

checks during tx as patient needs?

• Are febrile reactions addressed?

• Assessments?

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“Our Survey” Data Collection (cont.)

Laboratory reports for 3 patients who indicated their dialyzers are always red show a fall in Hct over the last 3 months; 2 additional records reviewed did not have this finding. Review of care plans, orders & progress notes finds no evaluation of the fall (Reviewed on 10/20/08).

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Task 12: Personnel InterviewsDone during the survey: “talking to the people doing the work”Will include the nurse manager, water

tech(s), reuse tech(s), patient care tech(s) & other nurse(s)

May include MSW, RD & medical director

If you have CfC findings, or findings related to medical director responsibilities, be sure & interview him/her

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“Our Survey” Data Collection Nurse manager

tells you that every dialyzer is to be rinsed clear when patient’s blood is returned at the end of treatment

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“Our Survey” Data Collection3 patient care techs

(#s 7, 9 & 12) tell you they have to finish the first shift of patients by 9:30 a.m. & sometimes they shorten the rinse- back procedure so the second shift of patients can start by 10:00. Interviews done on 10/20/08 from 9:15-9:35

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Document ReviewReview selected policies &

procedures“Our Survey” review of facility

policy (# 96-01) which requires rinse-back of blood until the dialyzer is clear unless the dialyzer is clotted & blood cannot be returned (Reviewed on 10/20/08)

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Task 13: QAPI

13a) QAPI documentation/interviewAreas that must be monitored

include:Dialysis adequacy (V629)Medical injuries/errors (V634)Nutritional status (V630)Dialyzer reuse program (V635,

362-368)Mineral metabolism (V631)More…

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Task 13a: QAPI

More areas that must be monitored:

Patient satisfaction & grievances (V636)

Anemia management (V632)Infection control (V637)Vascular access (V633)Technical functions (V627)

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Task 13a: QAPI

Facility must prioritize those areas that affect patient safety (V639, 640)

Develop and implement action plans aimed at making/sustaining improvement (V638)

Home modalities included; PD outcomes reviewed separately (V628)

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Task 13b: QAPI: ER Prep

Must address fire, power failure, water supply interruption, natural disasters & care-related emergencies (V408)

Annual staff training (V409)Patient education program (V412)Annual contact with local disaster

mgmt agency (V416)

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“Our Survey” Data Collection

QAPI minutes from 10/07–9/08 have no evidence of audits of reuse & no evidence management has identified any issue with blood return post-treatment

Facility staff have not reviewed their DRR nor compared their anemia management rate of 76% with the State average of 89%

Review done on 10/20/08

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Task 14: Personnel Record ReviewReview personnel document

completed by facilityChoose a sample to review for

orientation (V760), competency (V681), qualifications (V682-691, 694, 696), licensure (V681), certifications (V695), etc.

Review PCT training & certification (V693-695)

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Task 15: Decision Making

Review the data collectedDetermine what to cite,

level of citation, & if additional observations, interviews or record reviews are needed.

Organize for exit: use STAR or notes to make a list of deficient findings; start with most serious finding.

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Task 16: Exit Conference

Provide an overview of survey activities; briefly summarize deficient practices identified

Answer questions Describe next steps

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“Our Survey” Deficiency PresentedUnder the CfC QAPI:

V635: Hemodialyzer reuse program

(IG: the QAPI meeting minutes should demonstrate oversight of the reuse program …)

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Deficient Practice Statement

Based on review of data, observations, patient & staff interviews & review of records, this facility did not identify a fall in the Hct measures of 3 of 5 sampled patients as potentially related to the facility processes of reuse, impacting all 44 patients who were included in the reuse program in this facility as of the survey date.

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Findings

1. Review of facility data revealed 76% of the patients in this facility achieved the target hematocrit level of 30% for management of anemia, compared to the average of 89% for the State

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Findings (cont.)

2. On 10/19/08 at 9:30 a.m., 12 of 18 dialyzers used for the first patient shift were observed to be bright red after completion of dialysis, indicating blood was left in the dialyzer rather than returned to the patient.

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Findings (cont.)

3. On 10/19/08, from 11:30 to 1:15 a.m., interviews of patient #s 2, 4 & 5 found that their dialyzers were “always red” when their treatments were completed. A dialyzer that is red in color after treatment is completed indicates clotting of the dialyzer or incomplete rinse-back of the blood in the tubing & dialyzer.

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Findings (cont.)

4. Observation of reuse practices at 10:00 a.m. on 10/19/08 found 6 of 12 dialyzers from the first patient shift were dark red when brought to the reprocessing area. These 6 included dialyzers for patient #s 2, 4 & 5. These dialyzers rinsed clear & were not clotted.

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Findings (cont.)

5. Interviews of staff member #s 7, 9 & 12 on 10/20/08 from 9:15 to 9:35 revealed they “had to finish” the first shift of patients by 9:30 a.m. & that they “sometimes shorten” the rinse-back procedure.

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Findings (cont.)

6. Review of records on 10/20/08 for patients 2, 4 & 5 revealed lab reports showing drops in hematocrit over the past 3 months:

Jul. Aug. Sept. Patient 2: Hct 33.1 30 28Patient 4: Hct 30 29 27.8Patient 5: Hct 31 29 27There was no evidence in progress notes, plans of care, or orders of evaluations for reasons for the drops in Hct.

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Findings (cont.)

7. Review of facility policy # 96-01 on 10/20/08 revealed staff were required to rinse back the patient’s blood until the dialyzer was clear unless the dialyzer was clotted & blood could not be returned

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Findings (cont.)

8. Review of QAPI minutes from October 2007-Sept 2008 on 10/20/08 at 3:00 p.m. found no evidence of:a. Audits of reuse practices b. Identification of any issue with

blood return post-treatment c. Comparison of the facility’s

anemia management rate of 76% with the State average of 89%

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Findings (cont.)

All record review findings were verified with the nurse manager at the time of the finding.*****************************

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Goal: Positive Patient OutcomesThe renal community, State

agency & Network work together to improve patient outcomes!

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We Challenge You to Continue a Lifetime of Learning: WaterReuse Infection controlMachines & equipmentClinically complex patients!

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Questions?

Using the ESRD Survey Process for the 2008 Conditions for Coverage