CROWNWeb End Stage Disease Data Validation

CROWNWeb End Stage Renal Disease Data Validation Centers for Medicare and Medicaid Services (CMS) INTRODUCTION: This is a SOURCES SOUGHT NOTICE to determine the availability of 8(a) businesses that can provide support to CMS for data validation of End Stage Renal Disease (ESRD) (http://www.cms.gov/center/esrd.asp) administrative and clinical performance measure data. The CMS ESRD data collection system is known as CROWNWeb (Consolidated Renal Operations in a Web Enabled Network) Once nationally implemented, all dialysis facilities will submit both clinical and administrative data electronically to CROWNWeb in support of the updated Conditions for Coverage (CfCs) for ESRD dialysis facilities. Within the confines of ESRD data, there is a minimum set of data elements related to three significant areas to support the data validation effort: patient information; Clinical Performance Measure (CPM) values; and the ESRD Medical Evidence Form (CMS Form 2728) and ESRD Death Notification (CMS Form 2746). Through validation of these core data elements, CMS will be able to achieve a successful model of facility compliance and data accuracy. Eventually CROWNWeb data will be important to calculation of facility-specific scores and percentage payment reductions to implement the ESRD Quality Incentive Program (QIP) established under - 153(c) of the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008. HISTORY: CROWNWeb (http://projectcrownweb.org/crown/index.php) is a Web-based data-collection system that allows authorized users to securely submit and access patient-based data (both clinical and non-clinical) from virtually anywhere at any time. It is the tool designed by CMS to enable facilities to meet - 494.180(h) of the updated CfCs, published on April 15, 2008. This section outlines the electronic submission of administrative and clinical data by all Medicare-certified dialysis facilities in the United States - a move away from the current paper-based data-collection methods. CMS is leveraging this tool to streamline how the renal community will both report and access facility and patient data. The system is being released to the renal community in phases to allow CMS to conduct user analyses, while providing future users an opportunity to complete the required account activation process via the QualityNet Identify Provisioning System (QIPS) Account Form. Now in the second stage of its phase-in implementation process, CROWNWeb is at present allowing CMS to review data for more than 280,587 dialysis patients, representing over 74% of the total ESRD population in the United States. With the recent passage of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), CMS will launch the first ESRD Quality Incentive Program (QIP). Section 153(c) of MIPPA authorizes the establishment of a quality incentive payment program for ESRD providers, effective January 1, 2012. The provision requires providers of ESRD services to meet quality metrics endorsed by consensus-based, standard-setting bodies by demonstrating improvement or high levels of achievement. Those renal dialysis facilities that do not meet the specified requirements will receive a payment reduction of up to 2.0 percent, as determined by the Secretary. The main objective of the QIP is to improve the quality of care for Medicare ESRD beneficiaries through a focus on efforts to improve pre-determined clinical measures in the dialysis facilities. Another is to accurately measure performance by determining a performance score. In order to successfully establish an accurate QIP performance score, a data validation effort must be completed. CMS must ensure that the QIP program utilizes accurate, correct and useful data, and ensure that the CROWNWeb data is valid by verifying that ESRD administrative and clinical database records match original source data. CMS is conducting market research amount 8(a) vendor resources that may provide services to validate data entered in CROWNWeb, independent of the data submission process, and to determine the extent to which the ESRD database contains reliable and accurate administrative and clinical information. Typically, this would require a comparison of CROWNWeb data to original source data captured independently of CROWNWeb (e.g., the patient's medical record). DESCRIPTION OF WORK: The following services may be required over the phase-in period leading up to national implementation of the CROWNWeb data collection system: 1. Provide administrative, project management, and communications support requiring adherence to system and personnel security controls and data use agreements for access to CMS ESRD systems and CMS ESRD information. 2. Develop data validation sampling and statistical test procedures.. 3. Develop and chart process for data reliability activities. 4. Request data from participating dialysis facilities for medical review, chart abstraction, analysis and reporting of data validation activities. 5. Establish an Integration Continuity Document (ICD) of data elements to support this project. 6. Build a sampling tool/program using SAS or a comparable robust statistical package, which provides a Graphical User Interface (GUI), to select a minimum 10% random data sample from each facility participating in the CROWNWeb Phase. At the start of the contract, CMS anticipates about 360 participating faculties, which will increase to approximately 5500 participating facilities when CROWNWeb is fully implemented. Each facility will have a required minimum sample size of five (5) records selected, not to exceed a maximum of twenty-five (25) records selected. 7. Practice continuous process improvement that promotes root cause analysis, and advances innovation/change proposals for improved accuracy and efficiency in electronic data submission. 8. Develop and conduct an educational and program for project clinicians without nephrology experience that focuses on hemodialysis and peritoneal dialysis medical records. 9. Provide a nephrology clinician/nurse Subject Matter Expert (SME) who is available to answer questions at all times. 10. Report results and data validity metrics to CMS and possibly contractors. STAFFING REQUIREMENTS: The responding source must have appropriate professional staff to fulfill the above work responsibilities, including but not limited to: 1. Staff with a working knowledge and specialized understanding of ESRD clinical issues, CMS' ESRD Program, including the ESRD Networks, and the expertise and experience in analyzing CMS administrative data and other ESRD clinical data. 2. Clinicians who have experience in nephrology and understand quality improvement and the application of professionally recognized standards of care. 3. Clinical staff with a working knowledge and specialized understanding of inter-rater reliability instruments, medical record review and abstraction and ability to develop an educational/training course for non-nephrology clinicians/nurses 4. Staff with an understanding of the three significant ESRD areas to support the data validation effort: patient information; CPM values; and CMS forms 2728 and 2746, received from multiple sources/entities. CAPABILITY STATEMENT Please provide your experience, knowledge and capability to provide the following (refer back to the points of work above): 1. Discuss your background and knowledge of ESRD clinical issues, CMS' ESRD Program, including the ESRD Networks, and the expertise and experience in analyzing CMS administrative data and other ESRD clinical data. 2. Discuss your knowledge and experience with the CMS regulations, policy, and instructions related to the ESRD administrative and clinical data collection. 3. Discuss your experience in analyzing complex processes, policies, instructions, etc., in order to complete detailed process mapping - and associated time allocation - aimed at identifying and developing more efficient and effective methods to complete work. 4. Provide evidence of relevant past experience and/or capability in developing and testing inter-rater reliability instruments. 5. Provide evidence of relevant past experience and/or your ability to build a sampling tool/program using SAS or a comparable robust statistical package, which also provides a Graphical User Interface (GUI) 6. Discuss your experience in receiving, compiling, analyzing, and reporting on health care data and clinical information, including information related to minimum set of data elements related to three significant ESRD areas to support the data validation effort: patient information; CPM values; and CMS forms 2728 and 2746, from multiple sources/entities. Interested parties having the capabilities necessary to perform the stated requirements may submit their capability statements via email to Yolanda Charon (yolanda. charon@cms.hhs.gov) (CAPABILITY STATEMENTS MUST DEMONSTRATE THE MINIMUM REQUIREMENTS OUTLINED ABOVE. Please address each in order listed above. Capability statements shall also include the following corporate information and be limited to 15 pages. If the responding source(s) include subcontracting arrangement (teaming, partners, etc), information shall be submitted for both. a. DUNS: b. Company Name c. Company Address d. Current GSA Schedules appropriate to this Sources Sought e. Do you have a Government approved accounting system? If so, please identify the agency that approved the system. f. Type of Company as validated via the Central Contractor Registration (CCR). All must register on the CCR located at http://www.ccr.gov/index.asp . g. Company Point of Contact, Phone and Email address h. Point of Contact, Phone and Email address of individuals who can verify the demonstrated capabilities identified in the responses. Subcontracting Arrangements: All subcontractor (teaming, partners, etc) arrangements shall also include the above-cited information and certifications for each entity on the proposed team. If a Joint Venture is being submitted, approval from the U.S. Small Business Administration must be included in the capability statement package. Responses must be submitted to the designated contract specialist not later than June 19, 2010. Capability statements will not be returned and will not be accepted after the due date. This is not an invitation for bid, request for proposal or other solicitation and in no way obligates CMS to award a contract. The sole intent is to obtain capabilities for set-aside and procurement planning purposes. Contact information: First Point of Contact: Yolanda Charon, Contract Specialist Alternate Point of Contact: Brian W. Hebbel, Contracting Officer