1. Clinical Indicator Goals Project
Shean Strong, QI Director
Lisle Mukai, QI Coordinator
ESRD Network 18
December 14, 2009

2. Clinical Indicator Goals Project
Background:
Clinical Performance Measures (CPM) Project:
Started in 1994
Random sampling of HD and PD patients
Collection of lab values
October – December (HD facilities)
October – March (PD facilities)

3. Clinical Indicator Goals Project
Laboratory values collected:
Hemoglobin
TSAT
Ferritin
URR
Kt/V
Albumin
Calcium
Phosphorus

4. Clinical Indicator Goals Project
Uses of data:
Provides comparative data for facilities
National and local benchmarks
Allows the Network to identify areas for improvement within patient care
Allows the Network to assess the standard practice of the community for specific clinical indicators
The basis for setting Network goals

5. Clinical Indicator Goals Project
Lab Data Collection (Elab) Project:
Started in 1998
Nearly 100% sampling of HD and PD patients
Collection of lab values for the last quarter of each year
Same lab values collected as CPM project
The Lab Data Collection Project, also known as the Elab Project is the collection, analysis, and reporting of comparative facility-specific lab data.
Lab values are collected for the last quarter of each year (October-December).

6. Clinical Indicator Goals Project
Uses of data:
Facility-specific generated reports
Provides comparative data for facilities
National and Network
Allow facilities to identify area(s) for improvement within patient care
Allows the Network to identify facilities who need to improve outcomes in specific clinical indicators
The results allow the Networks to identify facilities who do not meet CMS or Network goals.
These facilities are usually identified to participate in Network-driven projects
to improve patient outcomes.

7. Clinical Indicator Goals Project
Clinical Performance Goals - Network goals:
Goals are based on past performance, CMS thresholds and the NKF/KDOQI Clinical Practice Guidelines.
Provides a measurement tool to assess facility patient care processes and outcomes and identify opportunities for improvement.
The ESRD Networks perform oversight activities to assure appropriateness of services and protection for ESRD patients.
The Network together with the Network Medical Review Board develop Clinical Performance Goals based on past performance, CMS thresholds and the NKF/KDOQI guidelines.
Past performance is based on previous CPM Network results.

8. Clinical Indicator Goals Project
Expectation is that facilities not meeting expected performance standards be monitored by the Network and develop internal quality monitors to promote continuous improvement.

9. Clinical Indicator Goals Project
Clinical Performance Goals:
CPM Clinical Indicator
Network 18
(2008 CPM)
U.S.
(2009 LDC)
Network Goals for
(% of Patients)
Anemia Management
% of Patients with mean
Hgb > 11.0 g/dL. 84 82
Hgb < 10 g/dL. 4 5
4.6
< 4%
Hgb 10-12g/dL.
(CMS 2008 CPMs adopted effective 04/01/08.) 51 50 55
52%
Hgb > 12 g/dL
(As reported on the Dialysis Facility Report). 45
40.4
These goals were distributed to all Network facilities with the last QI mailing. They can also be found on the Network website under QI Tools and Forms.
The goal was established based on the Network’s 2008 CPM result in which you can see on this table was 4%. And as previously explained, Network clinical goals are based on previous CPM results. This means that majority of the Network facilities are achieving this outcome.
CMS continues to push the bar each year expecting better and better outcomes. Based on this fact and the Networks result, the Network MRB set the anemia sub-10 hemoglobin goal at < 4%.
The emphasis of quality improvement is to continuously strive for better outcomes thus improving the care given to our patients.
There are 3 other Networks with the results that were 4% or less and there are other Networks that have also set their goal at < 4%.

10. Clinical Indicator Goals Project
CPM Clinical Indicator
Network 18
(2008 CPM)
U.S.
(2009 LDC)
Network Goals for
(% of Patients)
Adequacy of Dialysis
% of Patients with mean URR > 65%. 88 89
87.6
89%
% of Patients with mean single session spKt/V > 1.2. 92 91 94
92%
% of patients with mean weekly Kt/V urea > 1.7. 84
88.9
CMS = 80%

11. Clinical Indicator Goals Project
CPM Clinical Indicator
Network 18
(2008 CPM)
U.S.
(2009 LDC)
Network Goals for
(% of Patients)
Nutritional Status
% of HD Patients with mean Serum Albumin > 3.5/3.2 g/dL (BCG/BCP) 85 82
84.4
85%
% of HD Patients with mean Serum Albumin > 4.0/3.7 g/dL (BCG/BCP) 42 34
40.2
% of PD patients with mean Serum Albumin > 3.5/3.2 g/dL (BCG/BCP). 62
69.8
65%**
** The goal was set by the MRB because PD patients lose albumin with the PD fluid.

12. Clinical Indicator Goals Project
CPM Clinical Indicator
Network 18
(2008 CPM)
U.S.
(2009 LDC)
Network Goals for
(% of Patients)
Vascular Access
% of Prevalent Patients with AVF 55 49
55.8%
(Fistula First SIMS report – March 2009)
CMS = 66%
NW goal = 57.8%
Stretch Goal = 58.0%
% of Prevalent Patients with AVG 23 22
20.6%
(Fistula First SIMS report – March 2009)
CMS/NW =
< 24%
% of Prevalent Patients with Catheter > 90 days 17 21
8.2%
< 10%

13. Clinical Indicator Goals Project
Quality Improvement Work Plan: (QIWP)
Requirement under the Network’s contract
Consists of 4 specific areas:
Vascular Access - Fistula First
Clinical Performance Measures
Network-specific quality improvement
Facility-specific quality improvement
Each Network is required by their contract with CMS to develop a Quality Improvement Work Plan for each contract year.
The QIWP provides a framework for the activities the Network will perform to improve processes and outcomes of patients during the contract year. The goal is to achieve improved care in identified areas.
The work plan is developed with the Medical Review Board and covers 4 specific areas:
Vascular access – Fistula First
Clinical Performance Measures
Network-specific quality improvement
and…. Facility-specific quality improvement
All quality improvement activities in the QIWP reflect the Network-wide needs based on CPM performance, Fistula First performance, Clinical Indicator project results, DFR reports and community standards.
They can also reflect suggestions from the Patient Advisory Committee, patterns of beneficiary complaints and grievances, clinical observations made during site evaluations, facility concerns, quality care issues identified by State Survey Agencies and other healthcare quality organizations.
They are prioritized according to seriousness, prevalence and CMS’s pre-approved targeted areas.

14. Clinical Indicator Goals Project
Inclusion Criteria:
Facilities not meeting Network goals for anemia
(4% of patients with Hgb < 10)
Patient census of > 50 patients (HD)
Patient census of > 20 patients (PD)
Exclusion Criteria:
Acute/transitional facilities
Patient census < 50 patients (HD)
Patient census < 20 patients (PD)
VHA facilities
Facilities participating in CROWNWeb Phase 2
In September we distributed run charts to all facilities that did not meet the Network goal for sub-10 hemoglobin based on the 2009 Lab Data Collection project – which was data for October – December Knowing that this data was about 9 months old, we distributed run charts for June-August 2009 to obtain more current data for these facilities.
Facilities selected to participate in this project were those facilities that did not meet the Network’s sub-10 hemoglobin goal based on these run charts.

15. Clinical Indicator Goals Project
Objective:
All facilities will be required to develop a QAPI (Quality Assessment and Performance Improvement) Plan utilizing the PDSA model to improve their sub-10 Hgb, implement those plans and monitor their progress.
Goal:
Decrease the percentage of patients with a Hgb < 10 by at least 2 percentage points by April 2010.
Timeline:
October 2009 – April 2010
The objective of the project is to have all facilities develop a QAPI plan utilizing the PDSA model to improve their sub-10 hemoglobin rate.
The facility is required to implement those plans and monitor progress.
A copy of the plan will be submitted to the Network office by January 15, 2009
The plan must be signed by the Medical Director prior to submission.
The reason we are asking Medical Directors to sign the plan is because they
are responsible for the QI program at the facility.
The goal of the project is for each facility to decrease their percentage of patients with a Hgb < 10 by at least 2 percentage points by April 2010.
Please note that the baseline data we will be using is the average of the 3
months run chart submitted by your facility for the June-August 2009 data.

16. Clinical Indicator Goals Project
Due dates:
Run Charts (June–August 2009): due September 30, 2009:
QAPI: due January 15, 2010
Quarterly Run Charts:
Oct-Dec 2009 (to be distributed in January)
Jan-Mar 2010 (to be distributed in April)
Taking the facility’s concerns into consideration the MRB decided that calculation for the quarterly run charts will be for prevalent patients (> 90 days) since incident patient results may drastically affect the facility’s rate.
And for those facilities that continue to be above the sub-10 goal, we will request that the facilities provide specific reasons for why each patient has a hemoglobin < 10.

17. Clinical Indicator Goals Project
Network Responsibilities:
Project Leader
Instruct/assist with the QI process
Distribute templates for RCA and PDSA
Distribute resources and evaluate their usefulness
Provide technical assistance as necessary
Conduct facility site visits as necessary

18. Clinical Indicator Goals Project
Facility Responsibility:
Conduct a root-cause analysis and develop a QAPI Plan
Submit a copy of the QAPI plan to the Network
Implement QAPI plan and revise as necessary during the project
Monitor facility’s progress towards achieving the goal
Follow project timelines/due dates
Submit requested documents for the project in a timely manner

19. Quality Assessment and Performance Improvement Plan (QAPI)
: (V626) Condition The dialysis facility must develop, implement, maintain and evaluate an effective, data driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team.
Quality Assessment and Performance Improvement (QAPI) Plan:
This is a condition level requirement.
The requirement states that:
The dialysis facility must develop, implement, maintain and evaluate an effective, data driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team.
Per the Interpretive Guidelines:
The professional members of the facility’s interdisciplinary team must participate in QAPI activities. This facility-based team is led by the Medical Director. Each team must produce effective quality assessment and performance improvement activities which positively influence the patient’s outcomes. Data on current professionally-accepted clinical practice standards must be used to track health outcomes, and the program must allow for identification, prevention and reduction of medical errors, mortality and morbidities.

20. Quality Assessment and Performance Improvement Plan (QAPI)
Interdisciplinary Team: (minimum)
Physician
Registered nurse
Social Worker
Dietitian
You may add other members to your team as necessary.
For example, some facilities have added PCTs and surgeons to their Vascular Access
team.

21. Quality Assessment and Performance Improvement Plan (QAPI) (continued)
Standard: Program Scope: 1. The program must include, but not limited to, an ongoing program that achieves measurable improvement in healthcare outcomes and reduction of medical errors by using indicators or performance measures associated with improved health outcomes and with the identification and reduction of medical errors.
An ongoing program continuously looks at indicators as they are available, trends outcomes and develops an improvement plan when indicated.

22. Quality Assessment and Performance Improvement Plan (QAPI) (continued)
Standard: Program Scope: 2. The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations.
Per the Interpretive Guidelines:
Facility data should be analyzed by the interdisciplinary team on an ongoing basis.
The facility must use broadly accepted, community-developed standards as
performance measures (this could be the MAT tool and CMS/NW goals)
The interdisciplinary team must work with inidvidual pateints who do not reach the
targets and it must be reflected in the patient’s plan of care for that outcome.
The facility should also track and trend data for improvement and sustainability of those improvements.

23. Quality Assessment and Performance Improvement Plan (QAPI) (continued)
Standard: Monitoring performance improvement: The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time.
Per the Interpretive Guidelines:
Tracking and trending, analysis of root causes, development of improvement plans,
implementation of those plans, evaluation of the success of the plan, and revision of
the plan must occur as indicated – which is basically re-measurement of your data
for improvements.
Once improvement is made, the facility must have a mechanism to ensure that improvements are sustained. This could be tracking and trending and having triggers to know when the facility needs to re-evaluate their plan or process.

24. Quality Improvement Process
The process involves:
Defining the problem
Investigating through gathering evidence
Identifying root causes
Implementing solutions
Monitoring those solutions to ensure they
continue to prevent the original problem.
Rootcauseanalybasics.com

25. Quality Improvement Process (continued)
Root Cause Analysis (RCA):
At its most basic, the process asks three questions, which together provide the framework of a root cause analysis investigation:
1. What was the problem?
2. What were the causes of the problem?
3. What actions should be taken to prevent the problem from occurring again?
Rootcauseanalybasics.com

26. Quality Improvement Process (continued)
Root cause analysis can use a variety of techniques to uncover root causes, including cause mapping, change analysis, the Ishikawa fishbone diagram, 5 Whys, and others.
All are designed to analyze the elements affecting a particular outcome to determine the root causes.
For this project we will supply the fishbone diagram for your root cause analysis.
Rootcauseanalybasics.com

27. Quality Improvement Process (continued)
Root Cause Analysis Investigations:
Every cause uncovered by RCA must be backed up by evidence.
RCA usually uncovers a system of root causes.
RCA uncovers specific causes and effects.
RCA results in executable, quantifiable solutions that may be monitored.
Rootcauseanalybasics.com

28. Quality Improvement Process (continued)
Root Cause Analysis Investigations: (continued)
RCA does not point blame at any one person or group, but simply identifies a system of causes and effects that lead to and incident.
RCA focuses on past events.
Rootcauseanalybasics.com

29. Quality Improvement Process (continued)
Fishbone Diagram
(aka: Cause and Effect Diagram)
The fishbone diagram will help to visually display the many potential causes for a specific problem or effect.

30. Quality Improvement Process (continued)
Fishbone Diagram (continued)
The Cause-and-Effect diagram can be used by individuals or teams - most effective by a group.
The team assists by making suggestions of possible causes until no more causes can be suggested.
Once the entire fishbone is complete, a team discussion takes place to decide what are the most likely root causes of the problem.

31. Quality Improvement Process (continued)
Fishbone Diagram: (continued)
Benefits of a fishbone diagram:
It helps teams understand that there are many causes that contribute to an effect.
It graphically displays the relationship of the causes to the effect and to each other.
It helps to identify areas for improvement.
Institute for Healthcare Improvement

32. When creating a fishbone diagram:
The problem is written as the “head” of the fish skeleton.
From there, the spines are all categories and specific causes that could contribute to
the problem.
After writing a possible cause for the problem, always ask “Why” it is occuring until
you get to the bottom of the cause – in which you cannot ask “why” anymore.
You can add as many spines on your fishbone diagram as needed.
This is an example of a fishbone diagram that we created for why facilities had AVF rates < 40%.

33. Quality Improvement Process (continued)
5 Whys:
Repeatedly asking the question “Why” to peel away the layers of symptoms which can lead to the root cause of a problem.
Although this technique is called "5 Whys," you may find that you will need to ask the question fewer or more times than five before you find the issue related to a problem.
Six Sigma (

34. Quality Improvement Process (continued)
Benefits Of The 5 Whys
Help identify root cause of a problem.
Determine the relationship between different root causes of a problem.
One of the simplest tools; easy to complete without statistical analysis.
Six Sigma (

35. Quality Improvement Process (continued)
Whys And The Fishbone Diagram
The 5 Whys can be used individually or as a part of the fishbone diagram.
The fishbone diagram helps you explore all potential or real causes that result in a single defect or failure.
Once all inputs are established on the fishbone, you can use the 5 Whys technique to drill down to the root causes.
Six Sigma (

36. Whys And The Fishbone Diagram
Combining the 5 Whys and the fishbone diagram:
Once you have the branches labeled on your fishbone diagram, begin brainstorming possible causes and attach them to the appropriate branches. For each cause identified, ask 'why does that happen?' and attach that information as another bone of the category branch. This will help get you to the true causes of a problem.
It would be advisable to have your team prioritize in some manner the key causes identified on the fishbone.
Six Sigma (

37. Quality Improvement Process: (continued)
Plan-Do-Study-Act: PDSA is the format the Network uses for developing a QAPI plan.
ACT
PLAN
Once you have determined a root cause(s). You can then develop your Quality Assessment and Performance Improvement plan using the PDSA (Plan-Do-Study-Act) model.
This model encompasses the elements of a QAPI plan as stated in the CfC requirements.
STUDY DO

38. Quality Improvement Process: (continued)
Quality improvement is a continuous cycle of planning, implementing strategies, evaluating the effectiveness of these strategies and reflection to see what further improvements can be made.
The PDSA model is a quick way to test for a change — by planning it, trying it, observing the results, and acting on what is learned.
Royal Children’s Hospital Melbourne – Clinical Quality & Safety

39. Quality Improvement Process: (continued)
PDSA approaches promote action by getting clinicians to reflect and brainstorm strategies that they hope will lead to improvement.
It also promotes evaluation of these changes once the strategies have been implemented.
Royal Children’s Hospital Melbourne – Clinical Quality & Safety

40. Quality Improvement Process: (continued)
PDSA is a cycle of improvement that involves asking three key questions:
1. What are we trying to accomplish?
2. How will we know that a change is an
improvement?
3. What changes can we make that will result
in an improvement?
What are we trying to accomplish? - Clarify improvements your team wants to make and define how you want
to change.
- Be specific.
How will we know that a change is an improvement? - Identify what you will measure to make sure you know whether the
change is truly an improvement.
What changes can we make that will result in an improvement? - What options are most likely to work?
- What do we think is a good idea?
- What have other people done?
- Keep objectives in mind.
- and….Use the team's knowledge and experience as a guide.
NHS Scotland (

41. PDSA Template PROJECT: TEAM: (List all members)
Adopted from IHI Website, June 2007
PROJECT:
TEAM: (List all members)
BACKGROUND: (Summary of facility’s identified problem and description of what the facility has been doing to improve the problem.)
Step 1.
PLAN:
Plan the test.
What is the objective of this improvement cycle?
What is the goal? (Include a numeric goal to achieve.)
Develop a plan to achieve the goal?
(List steps of the plan – this will allow you to identify the step that may need modifying/revising if necessary.)
2 of 3 pages
What data sources are needed for the test? (What data sources will you be using to monitor your progress?)
What measures are used to analyze if you are achieving the goal?
Baseline:
Measure: (Numerical formula)
Monitoring frequency:

42. Step 2.
DO:
Try out the test on a small scale.
Implement the plan. Document problems and unexpected observations.
Step 3.
STUDY:
Set aside time to analyze the data and study the results.
Analyze the results and compare the results with your goal.
Step 4.
ACT:
Determine if the test was successful or the plan needs to be revised.
If the test was successful, how will you implement the plan on a wider scale?
If it was not successful, what needs to be changed based on what you have learned? Should you continue to search for other root causes?

43. Quality Improvement Process: (continued)
Plan:
Set your objective for the project
Set goals to achieve (numerical goals and
a target date)
Develop your plan on how you will
improve your identified problem
Include a plan for collecting data
List data sources you will use to monitor
your progress for the project
Step 1: Plan
- State the objective of the test.
What are you hoping to accomplish with your plan.
- What is the goal? (Include a numerical goal and a date to achieve the goal.)
for EXAMPLE: Increase the facility’s AVF rate by 2% points by March 2010
- Develop the plan.
- Write your activities/strategies step-by-step (this will make it easy to go back to
your plan should you need to revise it because something in your plan did not
work as expected.)
- Please remember that you can only develop a plan for those issues you can control.
Make sure you also include a plan for collecting data
List what resources you will be using to monitor your progress.
EXAMPLE: Fistula First reports, Lab Data Collection reports, DFR reports, internal
tracking logs, etc.

44. Quality Improvement Process: (continued)
Plan (continued):
Write out the measure you will be using
to analyze if you are achieving your
goal. (numerical formula)
Example:
# of prevalent patients using AVF as primary access = AVF rate
Total # of patients at the facility

45. Quality Improvement Process: (continued)
Plan (continued):
Note the frequency in which you
will conduct measurement of your
progress
Note your baseline for comparison
towards your goal
Determine how often you will measure your progress (weekly, monthly, quarterly, etc.)
Monthly is usually ideal because patient labs are usually drawn on a monthly
basis thus allowing for easy trend analysis of results.
The frequency of your measurement and the trending of your data will help
you analyze whether your QAPI plan is progressing towards your goal.

46. Quality Improvement Process: (continued)
Do:
Implement your plan
Document problems and unexpected
observations of your plan
Study:
Analyze the results and compare it to the goal
This analysis should be conducted with the
interdisciplinary team.
Step 3: Study - Set aside time to analyze the data and study the results.
- Using your data sources, analyze the results of your plan with your interdisciplinary
team.
Track & trend your progress to easily visualize if you are moving towards
your goal.
Compare the data to your predictions. In other words, determine how much
improvement needs to be achieved on a frequency interval (monthly, quarterly, etc)
to reach your goal by the set time frame. This is considered a trigger.
For EXAMPLE: The Network Fistula First goal is 57.8%. Using March 2009 AVF rate of 55.7% as the baseline, the Network would need to increase 0.2 % points each month to achieve that goal.
So if the Network didn’t achieve this each month for a consecutive 2 months then we would assess our plan and make revisions to the plan to achieve the goal.
- Summarize and reflect on what was learned.

47. Quality Improvement Process: (continued)
Act:
Is your plan successful?
How will you ensure continued
improvement?
If it wasn’t successful, what needs to be
changed based on what you have learned?
Should you continue to search for other
root causes?
This step assess if your plan is successful – Are you moving towards your goal or have you already achieved your goal.
If you are successful, how will you ensure continued improvement?
- The facility can monitor improvements to ensure sustainability, develop a process
or policies & procedures, etc.

48. Plan-Do-Study-Act (PDSA) (continued)
The PDSA cycle is a continuous cycle. It allows you to frequently assess your plan and make revisions as necessary to achieve your goal.
Your plan should be reviewed at least monthly and/or when you realize that your strategy or activity is not working.

49. Quality Improvement Process: (continued)
Note your progress on your form so that you have a record of the strategies/activities you’ve attempted and results of those attempts as well as the revisions you have made to improve your plan.
Note your progress on your form so that you have a record of the strategies/activities you’ve attempted and results of those attempts.
Also note the revisions you have made to improve your plan.
By noting all of this down, it will help others know what your QAPI plan is and what activities you have implemented, whether they have succeeded or not. With frequent turnovers at the facilities, this will help the next person who will follow after.

50. Conditions for Coverage: Anemia Management
The ESRD Conditions for Coverage include anemia as one of the clinical indicators required to be addressed in both the patient assessment and the facility’s QAPI program.
FMQAI – Network 7

51. Conditions for Coverage: Anemia Management
Evaluation of factors associated with anemia, such as hematocrit, hemoglobin, iron stores, and potential treatment plans for anemia, including administration of erythropoiesis-stimulating agent(s).
V632:
Anemia management.
V405
Per the Interpretive Guidelines:
Each patient’s hematologic status must be evaluated for determination of their individual anemia management needs.
Evaluation should address the patient’s anemia, including an assessment of the need for erythropoiesis-stimulating agents (ESA) and/or iron therapy. Evaluation should also address the patient’s volume status, potential for bleeding, infection and other causes of hypo-response.
V632
The intent of QAPI in addressing management of anemia is to maximize the number of patients who achieve the goals for this area.
If facility QAPI goals for anemia management are not achieved over consecutive evaluation periods, the facility IDT should conduct a review of transferrin saturation (TSAT) levels, ferritin levels, and other iron indices; erythropoietin stimulating agent (ESA) doses and response to those doses; and any evidence of blood loss, such as repeated episodes of insufficient rinseback of red blood cells or prolonged bleeding post treatment.
If the facility uses a standardized anemia management guideline or algorithm, the IDT should evaluate the efficacy of this tool if facility QAPI goals for anemia management are not achieved over consecutive evaluation periods.

52. Factors that contribute to anemia or lead to ESA hypo-responsiveness:
Inadequate EPO dose
Iron deficiency (True or Functional)
Blood loss
Infection or inflammation
Aluminum toxicity
Factors that can contribute to anemia or lead to ESA hypo-responsiveness are:
Inadequate EPO dose
Insufficient EPO dose based on body weight, missed or held doses, frequent
dose changes, or hospitalizations
Iron deficiency – true or functional
True iron deficiency may be caused by blood loss or insufficient iron
replacement
Functional iron deficiency occurs when there is not enough iron delivered to
the marrow for RBC production
Blood loss from GI bleeding, clotting and/or poor rinseback of blood during dialysis
treatments, or bleeding from the vascular access
Infection or inflammation
Acute or chronic infections/inflammatory processes such as vascular access
infections, AIDS, rhuematological disorders, surgical inflammation, dental
ailments, and cancer
Aluminum toxicity may interfere with iron metabolism and cause microcytic anemia
(erythrocytes smaller size than normal)
FMQAI-Network 7

53. Factors that contribute to anemia or lead to ESA hypo-responsiveness: (continued)
Secondary Hyperparathyroidism
Co-existing medical conditions
Hemolysis
Malnutrition
Vitamin deficiency (B12, Folic Acid, B6)
Secondary Hyperparathyroidism due to bone changes
Co-existing medical conditions
Malignancy
hematologic disorders
AIDS
chemotherapy
etc.
Hemolysis
RBC destruction which may be caused by water-borne toxins in dialysate,
medications, hypotonic or hypertonic dialysis, mechanical problems, etc.
Malnutrition
which is indicated by a decrease in serum albumin
Vitamin deficiency of B12, folic acid, and B6 which are needed for blood cell
production.
FMQAI-Network 7

54. Factors that contribute to anemia or lead to ESA hypo-responsiveness: (continued)
Evaluation for hypo-response is indicated when patient response to EPO administration is not observed.
Once identified the underlying cause can be addressed
When the cause is resolved, ESA dose can be adjusted to prevent from exceeding recommended range.
FMQAI-Network 7

55. This slide is the Epogen Hyporesponse and Dosing Algorithm.
It touches on all the possible conditions that we just discussed.
Document from Amgen

56. Anemia Management: Lab Values
Laboratory Monitoring for Anemia:
Hemoglobin and Hematocrit
Transferrin Saturation (Tsat)
Ferritin
Reticulocyte hemoglobin content (CHr)
K/DOQI recommended lab values for monitoring anemia are:
Hemoglobin – which is a protien in red blood cells that carry oxygen
Transferrin Saturation – which measures the amount of iron available to make red
blood cells
Ferritin – which measures iron storage in the body
Another value that is also used to monitor iron status is the reticulocyte hemoglobin
content which measures hemoglobin content of the reticulocyte (which are immature
red blood cells)

57. Summary:
Facility to conduct a root-cause analysis of why your patients have a Hgb of < 10.
Develop a Quality Assessment Performance Improvement (QAPI) Plan to decrease the percentage of patients with a sub-10 hemoglobin.
QAPI must be signed by the Medical Director
Submit a copy to the Network by January 15,
ONLY STEP 1 (PLAN) is due
on January 15th.
In summary:
Project facilities will conduct a root-cause analysis of why your patients have a Hgb <
10.
They will develop a Quality Assessment Performance Improvement (QAPI) Plan to
decrease the percentage of patients with a sub-10 Hgb.
- The plan will be signed by the Medical Director
- And…. a copy of the plan will be submitted to the Network by
January 15, 2010.
- Please note that only Step 1 – Plan is due on January 15th.
- Facilities should be noting Step 2 along the way

58. Summary: Implement and monitor progress of your QAPI plan.
The Network will distribute quarterly run charts to monitor progress.

59. Project Communication:
To communicate more efficiently with you about this project and to be more eco- friendly, we are creating a listserv of all the facilities in this project.
In the past, we have had delivery problems with facility firewalls, please ensure you are able to receive s from us about the project.
Consult with your IT Department to
assist you.
Your facilities should have provided a contact information ( address) on your WebEx confirmation form. If not, please me so that I have that information.
If there are any changes to this please notify me with the current or correct information.

60. Shean Strong, MBA, QI Director sstrong@nw18. esrd
Shean Strong, MBA, QI Director Lisle Mukai, RN, QI Coordinator ESRD Network Network 18 website: