SOLICITATION NOTICE
R -- RFI W81XWH9R12497 - Blood Management Questions and Answers
- Notice Date
- 11/25/2008
- Notice Type
- Modification/Amendment
- 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
- 12/5/2008
- Archive Date
- 2/3/2009
- Point of Contact
- Barry Sayer, 301-619-1163<br />
- Small Business Set-Aside
- N/A
- Description
- The following questions and answers are provided for Sources Sought Request for Information, W81XWH9R12497. Submission instructions for responses to this RFI are provided below. The Submission date is changed to 05 December 2008. The orginal RFI was posted in the FedBizOpps on 05 November 2008. 1.We did receive a document titled IRD Process Decision Points and Process Steps from Initiation to Investment Decision. Does this refer to the Independent Research & Development process, or does it refer to the Integrated Requirements Design framework? Is this RFI W81XWH9R12497 linked to an IRD process? If so, how? The IRD Process Decision Points and Process Steps from Initiation to Investment Decision describes the Integrated Requirements Design framework. The document was provided to show how investment decisions are made by the MHS to assist the respondent in making recommendations for an acquisition strategy within the limitations of the MHS. See RFI Technical Solution #7. 2.Regarding Item 2: we currently have a DD572 we have been using to develop an SBIR project based in the Wright Patterson Air Force Base in Ohio. Is this the same one the RFI W81XWH9R12497 makes reference to? Yes. 3.Was this solicitation prepared with a particular vendor in mind? No. The intent of the RFI is to solicit information from industry on what is available in the market. No particular vendor is being sought out. 4.Could you be more specific as to what you are seeking in response to Question 2 or is the DoD simply looking for a high-level response? DoD is looking for a high level response. 5.Given the relative importance of the selection of a blood management system, would the DoD like to require the submission of financial statements from the participating vendors, along with a record of installations and references? Vendors are free to provide whatever information they would like as long as it conforms to the submission requirements, i.e. page limitations and font size. 6.Please provide a list of the manufacturers/models of the manual and automated data entry test equipment deployed in DoD clinical laboratories that require support. DoD clinical laboratory devices are not in scope for this effort. The following table lists the blood management test equipment within the scope of this RFI. Manufacturer - Instrument - Assays a. Immucor - Galileo ECHO ABO/rh, Antibody Screens, DAT, Crossmatch b. Immucor - Galileo - ABO/Rh, Antibody Screen, CMV, Syphilis, Weak D, DAT, Crossmatch c. Haemonetics IDM Surround - System LIS Interface with Galileo, Prism, Commander and NAT Tracker (TIGRIS and eSAS - interface system) d. Abbott Commander HIV 1 and HIV 2, HTLV e. Abbott PRISM HBc, HBsAg, HCV, HTLVI/II, HIV 1 and HIV 2, and O (future), Chagas (future) f. Chiron eSAS Procleix HIV-1/HCV/HBV (Ultrio), Procleix HIV-1/HCV (Multiplex), dHIV, dHCV g. Chiron Tigris Procleix HIV-1/HCV/HBV (Ultrio),Procleix HIV-1/HCV (Multiplex), dHIV, dHCV h. BioTest or Olympus Tango - ABO/Rh, Weak D, Antibody Screen, antibody ID, Phenotyping, Compatibility Test i. Digitrax - Software ISBT compliant label printing j. Olympus PK7300 ABO/Rh (front and back type) to include weak D testing; CMV; Syphilis; ABO/Rh (seg testing front type only). k. Ortho Provue - ABO/Rh, DAT, Weak D, Antibody Screen, Crossmatch 7.Will the solution require functionality/capability to manage tissue banking, stem cell or cord blood banking? Management of these functions/capabilities is NOT within the scope of this RFI. 8.Will the solution include functionality/capability to support nurse/phlebotomy bedside collect/transfuse workflow? If so, what requirements are needed? If not will integration with a third party solution be required? The solution must support transfusion workflow but not bedside collection workflow. The requirements are to capture the transfusion event details from request to completion, to include reaction if it occurs. Integration with a third party solution should be discussed in the response if relevant to approach. 9.Will validation services be required as part of the pre-deployment implementation services or will the DoD contract separately for these services? Yes 10.What is meant by automated lot release functionality? Lot release for products? Lot release for reagents? The proposed solution should screen against the minimum FDA requirements for lot release of products but not reagents. 11.With regard to question 1-F: How the solutions would support data sharing with organizations outside of the DoD (VA, Managed Care Support Contractors, Civilian counterparts)? Can you specify exactly what data elements are expected to be sent to these other systems? For transfusion services, the solution must share certain data elements of the SF-518 (Blood or Blood Component Transfusion) with the MHS Clinical Data Repository (CDR) for all transfusion requests and administrations. For donor processing the solution must share the data elements necessary to support the American Association of Blood Banks (AABB) National Biovigilance Program with non-DoD organizations. 12.Regarding the document IRD Process Decision Points and Process Steps from Initiation to Investment Decision that was sent with the Executive Summary Template, SF518, and Blood Diagram, we were not sure how this pertains to the RFI, or if we were intended to receive a different document. Can you please clarify how this document pertains to the RFI? See response to question #1. 13.Can you provide us with an acronym dictionary? The majority of acronyms were spelled out in the RFI however, Defense Blood Standard System (DBSS) and ABBP was not defined. The acronym ABBP is a typographical error. It should say ASBP which is defined in the RFI. If vendors require clarification for additional acronyms not used in the RFI, please contact the RFI Point of Contact. 14.Is it the intent of this RFI to indicate that the Defense Blood Standards System (DBSS) or future releases of DBSS do not meet the needs of the MHS? The intent of the RFI is to solicit information from industry on what is available in the market. 15.The solicitation states Contractors supporting the DoD team will review materials submitted in response to this RFI. Are any of these contractors from organizations that are involved with the development, implementation, marketing or sales of computer systems for blood? Have these contractors signed NDAs? All contractors supporting the review of this RFI response are Category 1 or 2 vendors who have signed Non-Disclosure Agreements (NDAs) and are excluded from bidding on work related to this RFI. 16.The solicitation states &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. Can you please define appropriate information? Is this information limited to look backs? Appropriate information is defined as a registry of person or blood product data to support donor deferrals across donor centers and product data to support look back respectively. 17.The solicitation states 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. Can you please clarify what the intent of the statement that This global repository does not need to be part of individual center or software activity. Since look backs would be conducted by the centers and presumably using automated systems how would it be possible for this repository not be part of individual center or software activity. The solution at individual sites and remote theater operations must be able to share information globally. This can be achieved by using either a central repository or sharing data between centers as needed. 18.Can you provide information on the standard formats referenced for sharing information with other MHS IT systems. Also, can you please list the other MHS systems to which the repository would have to connect. The standard format for sharing data with other MHS IT systems is Health Level 7 (HL7) messaging. The MHS IT systems the blood solution would have to share certain transfusion, training and inventory data with are: "Theater Medical Data Store (TMDS) "Clinical Data Repository (CDR) "Composite Health Care System (CHCS) "Joint Medical Asset Repository (JMAR) "MHS Learning Management System (MHS Learn) "CliniComp Essentris" 19.The solicitation states &the blood community desires to move toward automated self-screening processes. Can you please define the scope of the application considered for donor self-screening? At the time of donation, donors are presented with the questions from the DD572 (Blood Donation Record). The MHS is seeking a solution that would automate the screening process using a computer-assisted self-interview (CASI) that is FDA compliant and supports multilingual donors. 20.With respect to SF 518 the solicitation states 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). Is there a requirement to incorporate this form into a solution or could another format containing the same essential information be utilized? The same essential information can be utilized. 21.The solicitation states 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. Is this required or an optional requirement? Also this statement makes reference to a LIS. Is a LIS within the scope of this solicitation? A LIS is out of scope for this RFI, but we would review this information if it is provided. However, the documentation of pre-transfusion testing, compatibility testing, and quality control documentation must be recorded within the Blood AIS, this is not an optional requirement. 22.The solicitation states The Government will only review projects that are in commercial use and have maintained FDA compliance for at least 7 years. Can you please clarify what is meant by projects? In the normal course of product life cycles new and improved applications are produced to offer functional and technical advantages and to remain compliant with current federal policies and blood management practice standards. Would applications that are less than 7 years old but have an FDA clearance be considered as part of an overall solution if they are produced by companies having a significant track record of producing regulated applications related to blood. The vendor must be able to demonstrate that the solution proposed, or earlier iteration of the solution proposed, has been FDA 510K certified for at least 7 years. 23.Under the technical solution, In point a) the question What IT solutions exist today that meet the needs described is asked. The needs described are at a very high level. Are there more detailed requirements available in order to more precisely define the needs so that a detailed assessment can be done? If so, please provide a copy to us. See response to question #4. 24.Under the technical solution, Point d) states Also indicate how the solution would support activities which sporadically will have little or no internet connectivity. Can you please define the activities referenced here? The activities referenced are those unique to the military operations in support of combat aide stations, field hospitals, and shipboard medical operations where donations and transfusions also occur. These operations sporadically have little or no internet connectivity. 25.Under the technical solution, for point e) can you please provide information on the legacy data that you would want imported into a new system? The legacy data from the current MHS blood management IT solution must be incorporated into the proposed IT solution as computable data to support continuity of operations. The current solution data is in an Oracle database format. 26.Under the technical solution, for point f) please clarify what is meant by data sharing in this case and the data that you would want to share. Refer to response for question #11. 27.Under the technical solution, could you please define emergency as stated in point h) How will the solution provide flexibility for emergency operations ? Emergency operations such combat casualty or other mass casualty incidents may require that the MHS use products and processes not fully compliant with FDA standards. How will the proposed solution support this? 28.Under the technical solution, Point j) refers to a learning management system (LMS). Do you want a LMS as part of this solution and if so please provide the scope of training to be accommodated by this system. It would be optimal if there was an integrated LMS and/or training mode whereby users could navigate the system for training and/or running scenarios without using or otherwise impacting live data. 29.Under the technical solution, Point k), please provide the laboratory equipment from which you would want to have automated data transfer. Refer to response for question #6. 30.Under the technical solution, Point p), would this deferral registry extend to theater sites? Yes, when the theater site has connectivity. When the sites are experiencing low or no connectivity, the sites shall be able to query cached databases. 31.Under the technical solution, Point q), would the look back operation extend to theater sites? Yes, when the theater site has connectivity. 32.In several locations, comparisons to other possible solutions and alternatives are requested. Is this a request to provide comparisons against solutions offered by other vendors or are a variety of solutions being requested with comparisons between them? Each respondent is asked to provide solutions based on their knowledge and experience in the industry to include relationships with other products if, when combined, they meet the requirements. However, this is not a market survey. 33.Could you please provide copies of all the documents & information listed in the solicitation as being available from the Government POC? All Documents have been provided to those who have requested them. 34.In item 4 a discussion of cost drivers is requested. Do you want a cost estimate for the solution? If so more information will be required to prepare an estimate. The Government is interested in factors and/or options that can or will drive the cost of the proposed solution and options for dealing with cost factors. The Government does not require a cost estimate however; a Rough Order of Magnitude (ROM) to support proposed options would be beneficial. For item 7 please provide additional information so that an appropriate response can be prepared. No additional information is available. 35.Are the requirements in theater the same as in permanent locations? If not can you please describe the differences. The requirements as mandated by the FDA apply to both theatre and garrison (permanent locations). However, a solution for theatre must take into consideration that operations must continue as normally as possible during periods of limited or no connectivity. Additionally, in the theater environment, some blood, blood products, and processes not fully compliant with FDA regulations are utilized and must be documented and accounted for appropriately. The solution must support all of this with minimal inconvenience to the user. 36.How do you envision sites with sporadic internet connectivity accessing a global database? We are asking respondents to provide visions based on the constraints of proposed solution(s). 37.Will the Executive Summary stand alone as an independent document separate and distinct from the RFI? In other words, can we assume that no one will read or review the Executive Summary and never read or review the RFI? All information properly submitted under this RFI will be reviewed. 38.Does the maximum page number restriction for the RFI include the two pages for the Executive Summary? The Executive Summary is limited to 2 pages and is not included in the 30-page limit. Vendors responses should not exceed 30 pages plus the 2 page Executive Summary. 39.Was this RFI targeted to small business or is there a preference of any kind for small businesses to respond? There are no targets or preferences assigned to this RFI. 40.Will small businesses receive special or different ranking among responding vendors? No. 41.If we are partnered with a small business entity for government contracting, is it preferable or advantageous in any way for the response come from that small business as opposed to coming from us directly? Refer to response for questions #40 and #41. 42.Is it acceptable and/or advantageous for both us and our small business partner to respond to the RFI individually? Refer to response for questions #40 and #41. 43.Is there a special circumstance if a certain number of small businesses respond to the RFI (e.g. a set-aside)? If yes, does this result in a preferred contracting status for any small business over other non-small businesses? Refer to response for questions #40 and #41. 44.Is there an advantage of any kind if we were to emphasize our partnership with a small business entity? Refer to response for questions #40 and #41. 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 responses to the Government POC listed in #1, by 12 noon on December 05, 2008. 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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- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD<br />
- Zip Code: 21702-5014<br />
- Zip Code: 21702-5014<br />
- Record
- SN01710595-W 20081127/081125220453-173c90c54378926d9bd75183b9b07200 (fbodaily.com)
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