Transcript E.S.R.D. Survey Process - Welcome to the ESRD Network

Using the ESRD Survey Process
for the 2008 Conditions for
Coverage
Judith Kari
Glenda Payne & The Transition Team
1
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
2
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
3
Hospital-Based Dialysis
Based on integrated ownership &
operation
NOT…
• LOCATION
• Shared service agreement
• Patient referral agreement
At CFR 413.174
4
ESRD Benefit & the ESRD CfC
Do NOT Cover
Dialysis in an inpatient setting
Acute dialysis
(These are covered by hospital PPS
& surveyed under Hospital COP)
Pre-ESRD: Stages 1-4 Chronic
Kidney Disease (CKD)
5
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
6
Challenges for ESRD Surveys
Surveys are technically & clinically
complex: Not intuitive
Equipment & technologies keep
changing: Need updated
information
Large number of V-tags: ~400
Recognized Standards: Need
updated information
Workload competition: Not
statutorily mandated
7
8
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
9
Direct Partners in Guidelines &
Standards: Incorporated in
Regulations
AAMI:
• 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
10
Partners in Standards
FDA
• Approval of devices, including
manufacturer’s guidelines
• Reports on malfunctions
NKF
• Kidney Disease Outcomes Quality
Initiative (KDOQI)
• Community-accepted guidelines for both
“minimum” & “target” outcomes
NQF
• Develop CPMs
11
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
12
Surveyor Use of
Standards & Guidelines
POC: 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
13
Measures Assessment Tool
(MAT)
Developed to allow updating as
Standards change
Includes 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
14
The BASIC Survey Process
Used for recertification
Organized around TASKS
Focus of this session!
15
The INITIAL Survey Process
Use the Basic survey process as
the base for”
Initials
Complaints
Relocations
Change in service
16
STAR: Automated ESRD Survey
Surveyor Technical Assistant
for Renal Disease (STAR)
An automated survey guide
Uses a wireless tablet PC
Guides YOU through the
survey process
Roll-out in process
17
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
18
Pre-Survey Activities
Review of facility file
• Problems, complaints
• Previous surveys
Review of data
• Outcomes List
• Dialysis Facility Reports (DFRs)
Contact ESRD Network
19
Using Data/Outcomes in ESRD
Survey
Pre-survey:
• Use Outcomes List to select facilities
• Use Dialysis Facility Reports to plan
survey
During survey:
• Use data to focus survey
• Expect QAPI action if poor outcomes
identified
Post-survey:
• Data may define the citation level (i.e.
standard, conditional, or Immediate
Jeopardy)
20
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
21
ESRD Data Reports for Surveys
1. 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
22
Clicker Question!!
My state uses the outcomes list to
choose facilities for survey each
year.
1. Yes
2. No
3. I don’t know
4. I don’t work for a state
23
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
24
Clicker Question!!
I have easy access to the DFR for
every survey.
1. Yes
2. No
3. I don’t know
4. I don’t work for a state
25
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
26
Clicker Question!!
I routinely use the DFR for every
survey.
1. Yes
2. No
3. I don’t know
4. I don’t work for a state
27
Why Do Surveyors Use Data?
To SELECT facilities to survey
To FOCUS the survey process onsite
(look at current data, QAPI)
To DETERMINE the extent of
noncompliance (enforcement)
28
What Other ESRD Data Is
Available?
CROWNWeb
Dialysis 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
29
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
30
Survey Tasks
1.
2.
3.
4.
5.
Pre-survey prep
Introductions
Tour/Observations
Entrance conference
Patient sample
selection
6. Water treatment/
Dialysate preparation
7. Reprocessing/Reuse
8. Machine operation/
Maintenance
9. Home training dept
review
10. Patient interviews
11. Medical record review
12. Personnel interviews
13. QAPI
14. Personnel record
reviews
15. Decision making
16. Exit conference
31
“Our Survey” Data Shows
 DFR shows 76% of the
patients have hematocrit (Hct)
> 30% (State average =
89%)
32
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!
33
Task 2: Introductions
Is BRIEF
Introduces the members of the
team to the person in charge
Briefly explains the purpose of
the survey
34
Task 3: Tour/Observations
Ongoing throughout survey
Physical environment
Infection control
Patient/staff interaction
Patient care delivery
Staffing
Medical records/logs in use
35
Task 3a: Environmental Tour
3a: ”Flash survey” of all areas:
Waiting room
Patient restrooms
Reuse room
Water /Dialysate areas
Home training area
Treatment area
Isolation
36
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)
37
Task 3b: Observe Care
Infection control practices
Patient care
Dialysis machine & dialyzer use
38
Observe Care
Are 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)
39
3c: Emergency Equipment
Review for equipment function
(V413)
Staff emergency preparedness
(V409, 411)
Evacuation supplies present/in
date (V408)
Fire extinguishers present (V417)
40
“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
41
Task 4: Entrance Conference
Purpose/ anticipated schedule
CMS 3427 to complete
Collect facility specific info: use
STAR or worksheet & reference
materials list
Request patient sampling info
42
Task 4: Entrance Conference
Review the
facility-specific
data report with
the manager
Ask for current
data
43
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
44
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
45
Task 6: Water Treatment &
Dialysate Preparation
6a-Observation/ Interview
Talk 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)
46
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)
47
Task 6c: Review Of Dialysate
Prep & Delivery
Observe mixing if possible
Batches 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)
48
Task 7: Reuse
Task 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
49
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 (V362368); reviewed in QAPI (V635)
50
Task 7c:
Centralized Reprocessing
Note: 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)
51
“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.
52
Task 10: Patient Interviews
Try for a minimum of 5 patients
Can be same sample as records
reviewed or different
Done in treatment area, waiting
room, in private, or by phone
Use a structured interview guide—
in STAR, our guide
or “custom”
53
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)
54
“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
55
Task 11: Medical Record Review
Review 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
56
Task 11: Medical Record Review
How will we know the POC is
implemented?
• Physician’s orders
• Laboratory values
• IDT progress notes
• POC changes/ updates
• Dialysis flowsheets
57
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?
58
“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).
59
Task 12: Personnel Interviews
Done 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
60
“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
61
“Our Survey” Data Collection
3 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 rinseback procedure so the
second shift of patients
can start by 10:00.
Interviews done on
10/20/08 from 9:159:35
62
Document Review
Review 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)
63
Task 13: QAPI
13a) QAPI documentation/interview
Areas that must be monitored include:
Dialysis adequacy (V629)
Medical injuries/errors (V634)
Nutritional status (V630)
Dialyzer reuse program (V635, 362368)
Mineral metabolism (V631)
More…
64
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)
65
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)
66
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)
67
“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
68
Task 14: Personnel Record
Review
Review personnel document
completed by facility
Choose 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)
69
Task 15: Decision Making
Review the data collected
Determine 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.
70
Task 16: Exit Conference
Provide an overview of survey
activities; briefly summarize
deficient practices identified
Answer questions
Describe
next steps
71
“Our Survey” Deficiency
Presented
Under the CfC QAPI:
V635: Hemodialyzer reuse program
(IG: the QAPI meeting minutes
should demonstrate oversight of
the reuse program …)
72
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.
73
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
74
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.
75
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.
76
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.
77
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.
78
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
28
Patient 4: Hct 30
29
27.8
Patient 5: Hct 31
29
27
There was no evidence in progress notes,
plans of care, or orders of evaluations for
reasons for the drops in Hct.
79
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
80
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%
81
Findings (cont.)
All record review findings were
verified with the nurse manager at
the time of the finding.
*****************************
82
Goal: Positive Patient Outcomes
The renal community, State
agency & Network work together
to improve patient outcomes!
83
We Challenge You to Continue a
Lifetime of Learning:
Water
Reuse
Infection control
Machines & equipment
Clinically complex patients!
84
Using the ESRD Survey Process
for the 2008 Conditions for
Coverage
Questions?
85