SOURCES SOUGHT
R -- DEPARTMENT OF DEFENSE (DOD) BLOOD MANAGEMENT
- Notice Date
- 11/5/2008
- Notice Type
- Sources Sought
- NAICS
- 541511
— Custom Computer Programming Services
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH9R12497
- Response Due
- 11/28/2008
- Archive Date
- 1/27/2009
- Point of Contact
- Barry Sayer, 301-619-1163<br />
- Small Business Set-Aside
- N/A
- Description
- The results of this RFI are NOT intended to result in the issuance of an RFP or RFQ. Introduction: USAMRAA on behalf of the Department of Defense has developed this Request for Information (RFI) to support the efforts to acquire and implement applications to support Blood Donor Screening and Blood Transfusion Services within the Military Health System (MHS). This RFI is intended to solicit information from industry on current system capabilities to support the analysis for this project. The desired outcome of this RFI is information on potential solutions that are available to meet the MHS needs for Blood Donor Screening, Transfusion Services, and data sharing from/to these systems from other MHS IT systems. The Government does not desire to receive nor will the government review individual corporate marketing materials or slick sheets. The Government will not review information about products that do not meet the minimum specification listed. Please see submission procedures listed at the end of this notice. Contractors supporting the DoD team will review materials submitted in response to this RFI. The respondents agree upon submission that any material submitted in response to this RFI may be used in part or in whole by the Government as required to support the DoD Blood Management Project. Background: In support of the blood program, the major functional activities of the Armed Services Blood Program (ASBP) are marketing, procuring, collecting, testing, processing, freezing, shipping, storing, distributing and transfusing blood and blood components. To support these activities the DoD maintains 23 Donor Centers and 70 Transfusion Service Centers in peacetime, as well as military/humanitarian contingency operations worldwide. As a result, a solution that supports the full spectrum from donor registration, and transfusion is required as well as an ability to share appropriate information between individual centers to include the ability to create a look back (i.e., blood product traceability) across all centers and MHS use of the blood management system. This global repository does not need to be part of individual center or software activity, but any solution must have the ability to share information in standard formats to other MHS IT systems. To this extent, ASBP is only interested in a single solution, or donor and transfusion services that have been previously integrated so that the government deals with a single vendor. Prior to the late 1990s, the DoD Blood Banks (donor centers and transfusion services) used manual processes to comply with required documentation. Patient and test data was transcribed by hand onto labels, logs and result forms; look backs required manual examination of blood transfusion and donor records; patient and donor records were retrieved manually; inventory counting was done manually resulting in over collection and increased number of expired blood units. In response to the need to automate blood management processes, the Military Health System (MHS) developed an automated information system (AIS) to support the ABBP, the Surgeons General and MHS personnel readiness. The current legacy system, the DBSS, is designated by the Food and Drug Administration (FDA) as a Class II Medical Device (510K). DBSS v3.04 is the AIS currently maintained by the ASBP to manage donor and transfusion workflow. The legacy system exchanges data with other AISs within the MHS. Donor eligibility is determined via a standardized screening process as required by the FDA and the AABB (formerly the American Association of Blood Banks). The ASBP uses a paper form (DD Form 572, Blood Donation Record) to capture the donors health history. A sample of the form can be obtained on request to the Government Point of Contact (POC) listed in the Submission Procedures, below. The health history questionnaire serves as the first step in the collection process for protecting the blood supply and potential donor. The DD Form 572 has incorporated changes over the years due to the emergence of new diseases and donor eligibility criteria. The length of the form has been expanded to its maximum capacity with the addition of new questions that need to be captured for the screening process. The goal is not to maintain the form but to obtain a capability for the MHS that is FDA compliant and meets all current standards of donor/transfusion practice. A blood donor center staff member must review and interview the potential blood donor upon completion of the questionnaire. This increases the blood donor centers staff workload and poses a time constraint on the number of donors that can be processed during a given day. The goal is to process 100 donors over a one hour period. In an effort to improve the process, the blood community desires to move toward automated self-screening processes. There is documented evidence from behavioral science literature that automated blood donor screening systems are a great enhancement over manual procedures based on the following: a. Donors are more apt to respond to high-risk behavior questions truthfully; b. Eliciting sensitive behavioral information is less of a burden on blood donor center staff and; c. Automated systems ensure all qualifying requirements are met prior to donation. The DoD Standard Form (SF) 518 is the blood product request form and patient transfusion record. A sample of the form can be obtained on request to the Government Point of Contact (POC) listed in the Submission Procedures, below. The form is used to supplement the current blood management AIS, because the form has not been completely integrated into the Laboratory Information System (LIS) and the hospital Electronic Health Record (EHR). In an effort to improve transfusion service efficiency, the documentation of pre-transfusion testing, compatibility testing, and quality control documentation can be recorded within the Blood AIS or LIS. This enhances blood product utilization monitoring and supports electronic cross match capability. The MHS needs to maintain compliance with FDA Good Manufacturing Practices in a timely and cost effective manner. Accordingly, the MHS desires to examine alternatives that will meet Blood Management in the areas of blood donation process management and blood transfusion service management. The Government will only review projects that are in commercial use and have maintained FDA compliance for at least 7 years. A graphical system overview can be obtained on request to the Government Point of Contact (POC) listed in the Submission Procedures, below. Questions/Items: The Government desires that respondents offer their experience and recommendations on the following questions as well as details the capabilities of specific known system(s): 1. TECHNICAL SOLUTION: a.What IT solutions exist today that meet the needs described and have proven their ability to be used in multiple environments while remaining FDA compliant over at least a 7 year period? b.What aspects of these solutions should the DoD consider as absolute requirements of the future MHS system? c.Which solution is most likely to result in a successful Blood Management solution and why? (Specifically describe how this solution will support each of the capabilities.) If the solution is best of breed, explain how historic integration into a single solution set has been maintained? d.Provide overview of the proposed solution from a functional, technical, and clinical perspective. This view should clearly show how data sharing currently occurs from/to the solution or how it could occur in the future if it does not currently exist. Be sure to consider the entire system lifecycle. Also indicate how the solution would support activities which sporadically will have little or no internet connectivity. e.How the system is able to incorporate historic electronic data from legacy applications? f.How the solutions would support data sharing with organizations outside of the DoD (VA, Managed Care Support Contractors, Civilian counterparts)? g.How would the solution provide for a global database for blood inventory management activities during peacetime, military and humanitarian contingency operations? h.How will the solution provide flexibility for emergency operations? i.How does the solution document storage conditions? (Prefer to be able to have the freezers & refrigerators send data directly to the solution.) j.How does the solution document training? Is there an interface with a learning management system (LMS)? Does the LMS allow users to interrupt a training module and return to same place at a later time? k.How does the solution accept manual and automated data entry from laboratory testing equipment? l.How does the solution support an automated donor screening (ADS) solution? Does the ADS process support multiple language capabilities (English, Spanish, spoken versus written languages, etc.)? m.How does the solution interface with eDonor system (e.g., an existing self-scheduling solution for Donor Relationship Management)? n.How does the proposed solution support the Confidentiality Unit Exclusion process (i.e., maintaining donor confidentiality in the event a donated unit is excluded from transfusion or processing)? o.How does the proposed solution support automated lot release functionality? p.How does or can the proposed solution support an enterprise-wide or integrated global donor deferral registry? q.How does the proposed solution support global donor/patient look back functionality? r.How does the proposed solution support ICCBBA (International Council for Commonality in Blood Bank Automation) blood product code updates, International Society of Blood Transfusion (ISBT)-128 label printing and Codabar linear barcode symbology for product handling? s.How does the proposed solution allow for scalability of donor centers and transfusion service centers? (Anticipate a minimum of 10 workstations per donor center and 5 workstations per transfusion service centers) 2. BENEFITS: What are the functional, clinical and technical benefits (both qualitative and quantitative) of the recommended solution relative to the other possible solutions? 3. TIMELINE: What is a feasible and realistic implementation timeline for the recommended solution? Specifically, the focus should be on the initial training and deployment timelines for a single center with the assumption that additional centers/sites would be acquired/deployed sequentially. 4. COST DRIVERS: To the degree practicable, please discuss the costs drivers and components associated with the proposed solution? How do these costs compare to other potential solutions? Be sure to consider costs across the entire system lifecycle. 5. RISKS: What are the most significant risks involved with the recommended solution? How do these risks compare to other alternatives? How will the risks for the proposed solution be mitigated? 6. GOVERNANCE STRUCTURE AND MANAGEMENT APPROACH: What type of governance model and organizational structure would you recommend for this effort? Consider technical and non-technical aspects and provide examples of comparable joint management efforts. 7. ACQUISITION STRATEGY: What type of acquisition strategy would you recommend for this type of solution? Include pricing strategies in your response. Please consider the pros and cons of alternative deployment approaches. 8. LESSONS LEARNED: What lessons learned would you offer to the DoD for planning and implementing a Blood Management solution? Please note how workflow and integration issues were addressed in projects of similar complexity. Please identify areas where quick wins can be achieved and areas that will be most difficult. 9. INDUSTRY STANDARDS AND COMPLIANCE: Describe how the proposed solution will comply and remain compliant with current federal policies and blood management practice standards. If the solution will not be based on industry standards, please explain why a non-compliant solution is proposed, and potential impact of using a non-standard solution. Submission Procedures: Please follow the steps described below when submitting a response to this RFI: 1) Contact Ms. Janet Fuller at Janet.Fuller@tma.osd.mil to obtain and copy of the Executive Summary submission template and the additional background information described herein. 2) Develop a response that does not exceed 30 single sided pages using Times Roman 12pt font. It is requested that the response focus on the identified strategic questions and that corporate information be limited to not more than 3 pages. 3) Complete the RFI Executive Summary submission template. Once complete, this template should not exceed 2 pages. 4) Submit All Questions by 14 Nov 2008 to Janet.Fuller@tma.osd.mil. No questions will be answered after 14 Nov 2008. 5) Submit all responses to the Government POC listed in #1, by 12 noon on 28 November, 2008. Please direct any questions or comments to Ms. Fuller at the e-mail address above. No telephonic questions will be accepted. This is a new initiative; there is no incumbent contractor or existing contract. The above named POC must be contacted and additional information requested to submit a response to this RFI. Failure to make contact will result in your submission being discarded. All information submitted in response to this RFI is subject to public release, proprietary or trade secret information should not be submitted. The Contracting Officer does not have any additional information for this RFI.
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