J-7_Quality_Improvement_Activities.docx

Attachment J-7 Quality Improvement Activities

Table of Contents

I. Overview

As part of the Network's role in improving the quality of ESRD care, the Network shall work to improve processes and outcomes of patient care by developing, implementing, and evaluating quality improvement interventions in collaboration with ESRD providers and other partners.

Federal regulations at 42 CFR §405.2134 require as a Condition for Coverage under 42 CFR Part 405, Subpart U, that an ESRD provider must participate in Network activities and pursue Network goals. Failure to comply will result in a referral to the State Survey Agency.

The Network's quality improvement responsibilities include, but are not limited to, improving patient care processes and outcomes by:

Developing and conducting Quality Improvement Activities (QIAs) as directed by the ESRD Network Statement of Work (SOW)

Implementing any additional QIAs as required by CMS

Monitoring, tracking, analyzing and disseminating Network- and facility-specific clinical outcome data to identify opportunities to improve care in the Network area and developing Network-specific QIAs to address these opportunities for improvement

Upon request by a facility and/or upon identifying poor performance and/or upon identifying a specific need, assisting dialysis facilities (either individually or in groups) in developing and implementing facility-specific quality improvement projects.

II. Quality Improvement Activities (QIAs)

The Network shall design and conduct QIAs as directed by the SOW. For some QIAs in the SOW, the topic area and/or evaluation measures are already pre-determined. Additionally, performance criteria with regard to the number of facilities, practitioners, and/or patients, as well as the amount of improvement required, may be pre-defined for any QIA. CMS reserves the right to modify these pre-defined criteria as necessary. Each SOW QIA may utilize a different form within this attachment. It is the Networks responsibility to understand the QIA requirements and utilize the appropriate form or template for each QIA. Please refer to the SOW as to which forms in this attachment are applicable.

CMS may direct the Network to develop additional QIAs based on identified performance gaps.

With approval from its Contracting Officer’s Representative (COR), the Network may also develop one or more QIAs based on identified performance gaps in the Network area. The Network shall identify a performance gap by comparing current performance to one or more guideline-based or empirically derived benchmarks of acceptable performance. The Network shall analyze national or Network-area data to develop an empirical benchmark when a national guideline does not exist.

Example: In investigating whether ESRD patients in a Network’s service area have a disproportionately high cardiovascular mortality rate, the Network uses Medicare claims data to calculate the cardiovascular mortality rate among non-ESRD patients for comparison purposes.

Example: The Network uses Kidney Disease Outcomes Quality Initiative (KDOQI) Clinical Practice Guidelines to determine whether facilities in the Network area are failing to meet established standards for dialysis adequacy.

III. Root Cause Analysis (RCA)

In developing a QIA, as required by CMS or as initiated by the Network, the Network shall begin the process by performing a root cause analysis (RCA). The design of the QIA shall be based on the results of the RCA.

An RCA is an essential component of all Network QIAs. An RCA is a formalized investigation focused on identification and understanding of the underlying causes of an adverse event or pattern of care.

The Network may use any professionally recognized tools such as, but not limited to, 5 Whys, a fishbone diagram, or failure mode analysis in conducting the RCA.

The Network shall apply the appropriate RCA tool(s) to identify the underlying issues creating a performance gap between current circumstances and the desired performance level. The Network shall use the tool(s) to generate quantitative and/or qualitative data that will provide insight into the necessary process changes that will allow the desired performance level to be achieved.

IV. QIA Plan

For each QIA within the SOW which does not have its own template, the Network shall complete a Short QIA Plan and submit it to the COR for approval and to the Government Task Leader (GTL) for comment. For the Grievance QIA, AIM2 Network-selected QIA, AIM2 National Hospital Coordination QIA and Quality Incentive Program (QIP) QIA, separate templates are provided in this document. The COR has final approval authority for the Short QIA Plan, although the QIA Short-Form should be reviewed by the AIM-specific GTL. See Exhibit 7-1 for the Short QIA Plan format. This is the standard form to be completed for contractually required QIAs that do not have their own template.

All QIAs shall be developed based on sound methodology, established scientific principles, and current published research in the relevant topic area(s). Each QIA shall focus on one or more process changes designed to improve the quality and safety of ESRD care. Provider education may be a component of a QIA, but CMS does not consider provider education to be a sufficient driver of change to be the sole component of an acceptable intervention.

The difference between a QIA and an educational campaign is that the QIA is intended to create process change, while an educational campaign is for educational purposes only, without the necessity to demonstrate process change.

In designing its contractually required QIAs, the Network shall use standardized CMS-approved definitions for clinical and process measures. The Short QIA Plan shall specify numerator(s), denominator(s), inclusion/exclusion criteria, the time period(s) represented by the data, and other elements of Exhibit 7-1.

For the Grievance QIA use the Template provided in Exhibit 7-3, using the instructions provided within the exhibit. For the AIM2 Network-selected project and AIM2 National Hospital Coordination QIA use the AIM2 Checklist provided in Exhibit 7-4. For the QIP QIA, use the QIP QIA template provided in Exhibit 7-5.

In developing a QIA not required by the SOW, either initiated by the Network or directed by the COR, the Network shall submit a QIA Proposal to the COR for review after conducting an RCA. The Project Proposal shall be a 1–2 page document that provides sufficient information to allow the COR to determine if the proposed activity is appropriate as a Network QIA. If the COR approves the Project Proposal as submitted, the Network shall submit a final QIA Plan for COR review. See Exhibit 7-2 for the Full QIA Plan format. If the COR requires any revisions, the Network will work with the COR to develop a Full QIA Plan that incorporates the COR-requested revisions.

V. QIA Monitoring

The Network shall report electronically on the progress of its QIAs as directed by CMS. The Network shall address any identified barriers in the Monthly Report.

The Network shall continuously reassess the effectiveness of its interventions through a rapid cycle continuous quality improvement process. The rapid cycle process shall take no more than 1–2 months per cycle. When an analysis indicates less than successful results, the Network shall modify the intervention(s) to address identified issues.

At the conclusion of any QIA, the Network shall provide a summary using Exhibit 7-3. The summary shall include a brief background and overview of the RCA findings, an overview of the intervention(s) implemented linked to specific RCA findings, and the results of the QIA, including any identified best practice(s).

VI. Corrective Action Plan

If the Network identifies a correctable issue that impacts the quality of care that dialysis patients are receiving at a facility, the Network shall request a Corrective Action Plan (CAP) from the facility unless the issue involves a potential violation of the Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services (ESRD CfCs) and/or a potentially life-threatening situation.

When the issue involves a potential violation of the ESRD CfCs and/or a potentially life-threatening situation, the Network shall notify the COR and refer the issue to the State Survey Agency. When a case meets CMS-specified criteria for a sanction/alternative sanction recommendation to CMS, the Network shall follow CMS-specified procedures for making the sanction/alternative sanction recommendation.

A request for a CAP may be data-based or based on other assessable performance, but must state clearly the issue(s) that warrant improvement. The facility’s CAP must specify:

The goals and objectives to be achieved

The process/measurements/tools to be used to assess the issue(s) and to measure improvement

The timeframe for accomplishing the goals and objectives of the CAP, including timeframes for monitoring/documenting improvement.

The action(s) taken to improve the quality of care, as described in the CAP, must be sustainable.

Exhibit J7-1. Short Quality Improvement Activity Plan (Short QIA Plan) Format

Note: To be used only for QIAs that is required by the SOW.

ESRD Network Number: ______________

ESRD Network Name: ______________

Contract Number: ______________:

I. Project Identifiers

Title of QIA AIM, Domain, and/or Sub-Domain or Other Clinical/Process of Care Topic Network QIA Contact Person Contracting Officer’s Representative Current Date Initial Short QIA Plan Submission Date Short QIA Plan Version Number.

II. Objectives

A. Clearly state the ESRD topic that will be addressed in the project. Do not restate what is in the SOW; this should be customized to the individual project.

B. Outline:

1. The immediate process and/or outcome objectives and goals;

2. The clinical processes and related clinical outcomes to be measured and improved in this project;

3. The long-term goals and projected impact of the project; and

4. How the outcome(s) of the project will be sustained over time.

C. List:

1. The quality indicators that will be used;

2. The time period of the indicators;

3. The inclusion/exclusion criteria that will be used;

4. Any other population (patient/facility/practitioner) characteristics that are relevant to this project. This will help the Network to determine if a facility or practitioner is appropriate for the project.

III. Background

Describe the opportunity for improvement. Specify which groups are targeted for improvement. Address why the specific patients/facilities/practitioners were chosen for the project. Specify who will need to accept a change in behavior to improve performance for both processes and outcomes. Outline the potential for change. Specify, in general, what magnitude of improvement is expected. Indicate if prior projects or studies exist, and what they indicate about this effort.

IV. Methods Specific to Each Group Targeted for Change

Summarize:

. The data to be used;

. The methods to be utilized;

. The interventions to be used;

. The root cause analysis(es) conducted to determine the appropriate intervention and the resulting (baseline) data used to target the intervention;

. The feasibility and risks of the proposed intervention;

. The process for rapid cycle improvement for the project; and . What will happen with any facilities/practitioners that refuse to participate in the project and at what point the COR will be notified of the refusal.

V. Expected Results

Summarize the expected results. Include the expected process changes that will sustain the expected quantitative change(s).

VI. Appendixes

A. Bibliography (optional) B. Description of any data collection, abstraction, analysis, and/or evaluation instruments to be used in the QIA.

C. Any additional information for consideration by the COR in reviewing the QIA Plan.

Exhibit J7-2. Full Quality Improvement Activity Plan (Full QIA Plan) Format

Note: To be used only for CMS-directed or Network-initiated projects that are not part of QIAs defined in the SOW.

ESRD Network Number: ______________ ESRD Network Name: ______________ Contract Number: ______________

I. Project Identifiers

A. Title of QIA B. AIM, Domain, and/or Sub-Domain or Other Clinical/Process of Care Topic C. Network QIA Contact Person D. Contracting Officer’s Representative E. Current Date F. Initial Full QIA Plan Submission Date G. Full QIA Plan Version Number.

II. Objectives

A. Clearly state the ESRD topic that will be addressed in the project. Clearly and briefly describe how the QIA originated and why it is necessary.

B. Briefly summarize the results of the RCA. Briefly describe the proposed intervention(s) based on these results. This is an overview; more detail will be reported in Section III: Background.

C. Immediate process changes and/or outcome objectives: Describe the specific process changes and the specific related outcomes to be measured and improved in this project. Describe the long-term goals and expected impact of the project. Include a narrative description of the measures to be used in the project. Include the inclusion/exclusion criteria for the population and/or measures, and the rationale for their use. Describe the time period of the indicators. This is an overview; more detail will be reported in Section IV: Methods.

D. Define "improvement" in quantitative terms for each project-specific process and outcome indicator.

III. Background

A. Opportunity for improvement: Describe the size, severity, and consequences of the problem in the network area. Provide details on the results of the RCA, including the (baseline) data used to target the intervention

B. Potential for change: What factors come together to enable the Network to work effectively with the targeted patients, provider(s), and/or practitioner(s)? Which specific groups are targeted for improvement? Who will need to accept a change in behavior to improve performance for both processes and outcomes? This will help the Network determine if a facility or practitioner is appropriate for the project. Also specify, in general, what magnitude of improvement is expected?

C. Prior projects or studies: Have any previous projects (Networks, Quality Improvement Organizations, providers, etc.) attempted to improve performance in this area? What was the magnitude of improvement?

IV. Methods

A. Quality indicators: List the indicators to be used in measuring the listed processes and outcomes. Include the inclusion/exclusion criteria for every measure. Provide the time period for the indicators.

1. Process measure indicators

a. Numerator

b. Denominator

c. Formula

2. Outcome measure indicators

a. Numerator

b. Denominator

c. Formula

B. Project Setting

1. Describe and enumerate the clinical settings to be included (e.g., dialysis centers, physician offices, hospitals,other).

2. Describe the number of beneficiaries impact by the project.

C. Data

1. Sources: Describe the specific source(s) of the data to be collected, the specific data elements to be utilized in the analyses as described above.

2. Collection methods: Describe in detail the method(s), tools (existing or developed), and timelines required to collect the data for this project. All questionnaires and survey protocols must be pre-reviewed and approved by CMS and OMB.

D. Intervention

1. Description: Provide a summary of the project’s proposed intervention plan, including;

a. General description of intervention(s) and how they are derived from the RCA;

b. Indicators used for tracking the progress of the intervention (if different from the project's quality indicators);

c. Monitoring timetable; and

d. Evaluation processes to be used by the Network over the course of the project and potential corrective actions to be taken.

2. Discuss the specific process and outcome objectives for the target audience(s) for this project.

3. Discuss what will happen with any facilities/practitioners that refuse to participate in the project and at what point the COR will be notified of the refusal.

IV. Feasibility and Risk

A. Provide any known barriers or modifiers which that impact the success of the activity. Discuss Network activities to mitigate any barriers identified. Discuss activities by the Network to otherwise increase the potential for success of the project.

B. Assess the likelihood that the intervention effect will be sustained beyond the implementation period. Describe actions the Network will employ to foster sustainability.

V. Results Summarize the expected results. Include the expected process changes that will sustain the expected quantitative change(s).

V. Appendixes

A. Bibliography, if available B. Data collection forms C. Data abstraction, analysis, and evaluation instruments D. Any additional information for consideration by the COR in reviewing the QIA Plan.

Exhibit J7-3. Final Quality Improvement Activity (QIA) Report Format

This format shall be used for all Network QIAs. Please limit to 6 single-spaced pages, unless otherwise directed.

ESRD Network Number: ______________ ESRD Network Name: ______________ Contract Number: ______________

· Project identifiers:

· Title of QIA

· Beginning and Ending Dates of QIA

· Network QIA Contact Person and/or Report Author

· Contracting Officer’s Representative

· Date of Report.

· Executive Summary (maximum one page)

· Background of the activity (1–2 paragraphs)

· Summary and conclusions of the RCA

· Description of the intervention(s) implemented, linked to RCA findings

· Description of any modification(s) to the intervention and the rationale for the change(s)

· Monitoring frequency and results over time of the QIA

· Interventions in place for facilities/practitioners to sustain and improve upon the results achieved

· Best practices learned from the activity.

Exhibit J7-4A: Grievance QIA Template Acknowledgement Letter Provided? Yes No Date: __________ Outcome Letter Provided?

Yes No Date: __________ Month: _______________ Year: _________________

Grievance Log

Date Grievance Filed: ________________ Grievance entered by (Staff person): ______________________________________________________ Reported to Facility Administrator/Clinic Manager? Yes No FA/CM Initials: _______ Name of Grievant: _____________________________________________________________________ Description of Grievance: ________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ Actions/Steps Taken:

Date: ___________ Actions/Steps completed by (Staff person): ______________________________ Date: ___________ Actions/Steps completed by (Staff person): ______________________________ Date: ___________ Actions/Steps completed by (Staff person): ______________________________ Resolution:

Was the grievant provided a verbal explanation of the above resolution?

Yes No Date: ___________ Was the Grievance escalated?

If so to whom: _________________________________________________________________________ *Please attach any documentation regarding the escalation of the grievance.

Exhibit J7-4B: Grievance Q&A Template

Grievance Process Q&A All patients, family members, and care partners have the right to file a grievance, internal or externally, without fear of retaliation.

What is a grievance?

According to the Centers for Medicare & Medicaid Services, a grievance is defined as:

“A written or oral communication from an ESRD patient, and/or an individual representing an ESRD patient, and/or another party, alleging that an ESRD service received from a Medicare-certified provider did not meet the grievant’s expectations with respect to safety, civility, patient rights, and/or clinical standards of care.”

Who should be responsible for receiving and documenting a grievance?

Everyone. Any staff person who receives a grievance is responsible for documenting the grievance in the grievance log and reporting the concern to the Facility Administrator/Clinic Manager for follow up. Patients, family members and care partners should be able to report any problems and/or concerns to anyone at the unit without complication. As care providers it is our obligation to create an environment that fosters open communication and patient engagement with a willingness to take every opportunity available to improve care.

Who is responsible for carrying out an investigation of a grievance?

The Facility Administrator/Clinic Manager should take the lead on investigating and resolving all grievances. If the grievance involves the Facility Administrator/Clinic Manager, the grievance should be investigated by that individual’s direct supervisor. This helps to create a process that is easy for the grievant to understand as well as eliminates questions about who they should follow up with if questions arise.

What fosters an environment that encourages patients, family members and care partners to voice their concerns?

· Ensure that all patients, family members and care partners are aware of the option to file a grievance internally at your unit, with Network 18 and with the Department of Health Services (DHS).

· Hang Network 18 grievance posters in an area that is visible to all patients and visitors.

· Place Network 18 grievance brochures in an area that is accessible to all patients and visitors.

· Consider making your own grievance materials that provide patients and family members with information about your internal grievance process. This may encourage the grievant to work with you prior to taking the concern to outside agency like Network 18 or DHS.

I have read the above statements and agree to create an environment that encourages patients, family members and care partners to voice their concerns without fear of retaliation. I will uphold my duty to receive and document any grievance that is reported to me.

Signature: _______________________________________ Date: _____________________________

Exhibit J7-4B: Grievance QIA Outcome Template

Date:

Dear_______________________:

We would like to inform you that the complaint you filed on ____________ has been conclued. You have been provided with a verbal explanation of the outcome of our investigation. We thank you for brining your concerns to our attention. If you have any additional questions or concerns, please contact________________ at ________________.

If you are dissatisfied with the outcome of your complaint you may contact:

ESRD Network XX Patient Services Department Street Address City, State, Zip Code Toll Free: Phone #

Or

Department of Health Service Licensing and Certification Division P.O. Box Street Address City, State, Zip Code Phone: Phone #

Kind Regards, Name Title

Exhibit J7-5. AIM2 Check-list for AIM2 Network-Selected and National Hospital Coordination QIAs

AIM 2 Project Check-list

PROJECT SELECTION:

The Network shall develop one Innovation Pilot Project that utilizes innovation to advance the purpose and strategic goals of the ESRD Network Program.

The ESRD Networks will choose one of following potential project areas so long as ≤25% of the target population has not met the desired outcome:

A. Improve Dialysis Care Coordination with a Focus on Reducing Hospital Utilization;

B. Improve Transplant Referral;

C. Promote Appropriate Home Dialysis Referral; or D. Support Improvement in Quality of life (KD-QOL).

□Project Selected:

□ Project population baseline derived from bottom quartile of measure (i.e., bottom 25%)

Baseline Measure for Target facilities/population :

DISPARITY:

The disparities are ordered. In order to move to the next number disparity there must be evidence to indicate that the lower numbered disparity has been assessed and ruled out. To assess the disparity, the Network must demonstrate that utilizing the same dataset as will used for performance evaluation that the Underserved value(s) are at least 5 percentage points less than for the non-underserved population on all measures for the topic selected for the baseline period. Networks must chose the highest order of disparity available for which all criteria are met:

1. □ RACE (Minority: AA, API, NA/AN vs. Caucasian; with minority at least 5% less) 2.□ETHNICITY (Hispanic vs. Non-Hispanic; with Hispanic at least 5% less)

□ If Ethnicity why not Race 3.□ FACILITY LOCATION (Rural vs. Urban; with Rural at least 5% less)

4. □GENDER (Female vs Male; with Female at least 5% less)

5.□ If AGE (Under 65 vs. 65 and over; with under 65 at least 5% less)

□ If Age why not Gender

Please provide the baseline numerators, denominators, and calculated rates for the disparity populations identified in your target facilities/population. If a disparity category is not present please indicate N/A for both cells in that Row. The Right Hand column “Total Target Population” should equal the Non-Disparity and Disparity groups added together. If an additional column is needed to provide for other populations, please provide a single “Other” column and provide the data for that column.

(if necessary) Total Target Population

Race

Ethnicity

Do

Location

Not

Gender

Use

Age

PROJECT ATTRIBUTES:

Networks shall indicate how each attribute below will be demonstrated. Networks shall provide concrete examples. CORs will be monitoring to see if the attributes are being met over the course of the contract evaluation period.

□RAPID CYCLE IMPROVEMENT

□ HOW:

□CUSTOMER FOCUS AND VALUE TO BENEFICIARIES, PROVIDERS AND CMS

□ HOW:

□SUSTAINABILITY

□ HOW:

□INNOVATION

□ HOW:

□BOUNDARILESSNESS

□ HOW:

□UNCONDITIONAL TEAMWORK

□ HOW:

INDIVIDUAL PROJECT REQUIREMENTS:

PROJECT A1: DIALYSIS CARE COORDINATION WITH A FOCUS ON HOSPITAL UTILIZATION

□ At least 500 ESRD patients must be sustained throughout the project

□ Baseline Hospitalization rate at least >25%

□ CROWNWeb data used for assessment

For Projects A2 and Project A3 (i.e., the National Hospital Coordination QIA), templates will be developed/provided based on the results derived from Project A2.

PROJECT B: Improve Transplant Coordination/Referral

□ At least 5% of Network ESRD population

□ Baseline transplant referral rate <25%

□ CROWNWeb data used for denominator; Network collects numerator

PROJECT C: Promote Home Dialysis Referral

□ At least 5% of In-Center Hemodialysis population used throughout project

□ Baseline Home Dialysis referral rate <25%

□ CROWNWeb data used for denominator, Network collects numerator

PROJECT D: SUPPORT IMPROVEMENT IN QUALITY OF LIFE

□ At least 250 ESRD In-center patients at March baseline

□ KDQOL is only measure to be used for assessment

□ Network must maintain 80% response rate

Exhibit J7-6. QIP QIA Template

Quality Improvement Activity Report Form Section 1.

Network Information

ESRD Network Number

ESRD Network Name

Contract Number

Facility Selection

Facility Name

Facility CCN

Baseline Results

Target (numeric)

Section 2.

Root Cause Analysis

Names of facility staff involved in RCA

Date RCA completed

What underlying issues did facility staff identify as potential causes for poor performance on the QIP measure(s) targeted for this QIA? Which root cause method did you use (e.g., Five “whys”)?

Section 3.

PDSA Cycle

Describe the intervention to address the root cause(s).

Intervention start date

Section 4.

Monthly Results