MODIFICATION
70 -- iMed Consent
- Notice Date
- 9/5/2007
- Notice Type
- Modification
- NAICS
- 541511
— Custom Computer Programming Services
- Contracting Office
- Department of Veterans Affairs;Acquisition Management Section/00D;1615 Woodward Street;Austin TX 78772
- ZIP Code
- 78772
- Solicitation Number
- VA-200-07-RP-0029
- Response Due
- 9/6/2007
- Archive Date
- 9/7/2007
- Small Business Set-Aside
- N/A
- Description
- JUSTIFICATION AND APPROVAL FOR OTHER THAN FULL AND OPEN COMPETITION (FAR 6.302-1) 1. Identification of the Agencies: Requesting Activity: Veterans Health Administration National Center for Ethics in Health Care 810 Vermont St, NW Washington, DC 20420 Contracting Activity: Department of Veterans Affairs Information Technology Acquisition Center (ITAC) National Enterprise Contracts (200/00D3) 1615 Woodward Street Austin, TX 78772 2. Description of Action: This is a Sole Source Justification in accordance with the Federal Acquisition Regulation (FAR) 6.302-1(a)(2)(ii)(A) to pursue an award of a firm fixed price contract, through the Department of Veterans Affairs (VA), without competition, for information technology (IT) services. Specifically, the proposed acquisition is being pursued as a non-competitive, firm fixed price contract for a base period of 12-months, with nine (9), 12-month options, in order to satisfy the strategic IT needs on behalf of the National Center for Ethics in Health Care. The proposed contractor for this action is: DIALOG MEDICAL 3075 Breckinridge Blvd, Suite 475 Duluth, GA 30096-4981 3. Description of Supplies/Services: The proposed contract will encompass the following: " Renew Subscription to Content Library for the iMedConsent library of clinical materials in English and Spanish iMedConsentT contains procedure-specific informed consent information (risks, benefits, alternatives, etc.) for all treatments and procedures performed in VA facilities that require signature consent. It also contains an extensive index of patient education documents, forms (including Advance Directives), drug information, and a wide selection of anatomical pictures and diagrams. These materials greatly improve the ability of VHA staff members involved in patient education to access and distribute consistent and thorough information to patients. All materials, except the drug monographs and anatomical images are provided in Spanish as well as in English. Dialog Medical regularly adds to and updates its Content Library. A summary of the new, deleted or revised consent documents is provided to the appropriate VA Field Advisory Committee (FAC). " Renew Software Maintenance for the iMedConsent program as modified for VA use Development " Provide regular application updates and releases that include corrections to reported defects, new program functionality and associated services. " Address VA requested program changes through regular program updates. " Maintain rigorous Quality Assurance effort, including Alpha testing on VA-specific system configurations and Beta testing at selected VA locations prior to general release. " Provide technical and end-user documentation for each program release. " Consult with technical representatives of other VA software vendors to assure interface operability. Support - Provide customer service to the VA (158 VA facilities and the VA Central Office). The main goal of Dialog Medical VA support is to answer inquiries and to resolve identified iMedConsent incidents in support of the Electronic Support for Patient Decisions Initiative across all VA facilities. Dialog Medical customer support addresses VA customer issues by: " Clearly identifying questions/problems and recording them " Classification of the question/problem " Question/problem investigation and diagnosis " Resolution follow up. " Software Enhancements for the iMedConsent program to include: "Clinical Context Object Workgroup (CCOW) User Context Sharing Enhancement - CCOW is designed to communicate the name (information) of the active user between various programs on the same machine. The user should only need to log into one application, and the other applications running on the machine will "know" who is logged in. The VA uses a product from a company, Sentillion, called Vergeance Locator to allow the sharing of patient information from Vista (electronic medical record system) across applications. This is also used with the interface from Vista to iMedConsent. Though patient information sharing is occurring, the user still is required to log into Vista again when launching iMedConsent. The proposal in the enhancement will update the interface to prevent that additional login. "Inclusion of VA Form 10-10EZ and 10-10EZR - Application for Medical Benefits (Enroll) and Updates; "Pharmacy-Signature Receipt of Drugs - iMedConsent to be used for patient signature receipt of drugs in the pharmacy. In particular, a barcode scanner scans the Rx number off the label of a drug prescription. The scanner acts like an input device for the computer and translates the bar code into a number. The number would be sent via interface to Vista\CPRS to extract the generic name of the drug, last fill number, patient information, etc. That information is used to populate a patient and prescription-specific form. Upon agreement, the patient signs the form in iMedConsent that the prescription refill has been received, and the digital copy of the signed form is stored in the patient's electronic medical record. The estimated value of the new 10-year action is approximately $40,000,000, including future enhancements. This estimated value is based on the projected requirements, as well as, the historical data of the work that has been accomplished thus far. 4. Authority: This acquisition will be conducted under the primary statutory authority of 41 U.S.C. 253 (c)(1) and 6.302-1, Only One Responsible Source and no other supplies or services will satisfy agency requirements. 5. Reason for Acquiring the Services Without Competition: The previous requirement was awarded in FY04 utilizing competitive procedures under the VA Procurement Contract for Hardware and Software (PCHS2), Indefinite Delivery, Indefinite Quantity (ID/IQ) vehicle. MPC was the contractor selected for award based upon the fact that their response offered the best value to the Government. MPC's subcontractor and the manufacturer of the software is Dialog Medical. Since award, MPC/Dialog Medical has acquired a unique combination of personnel with the proper blend of technical expertise and historical perspective of this program. MPC/Dialog Medical has established themselves as a responsible firm and has performed exceptionally well in supporting the Government's requirements. VHA Handbook 1004.1 outlines specific requirements for the informed consent process. A recent review in one VAMC found that the vast majority of informed consent forms failed to include data elements, such as the date and time the discussion took place, the names of the practitioners involved, an assessment of the patient's decision-making capacity, and the signature of a witness. In 2001 and 2002, individual facilities and several national program offices began exploring and/or promoting the use of computer technology to improve the process and documentation of informed consent. However, in March of 2003, the Health Systems Committee directed the National Center for Ethics in Health Care (Ethics Center) to work with other VHA national program offices and field-based experts to provide market research and thoroughly evaluate the desirability of national implementation of a computerized informed consent software product. A product called iMedConsent, by Dialog Medical, already available to VA through MPC and the PCHS2 contract, was determined most appropriate for VHA. However, a number of quality and safety concerns were identified that needed to be addressed. In July 2003, the Deputy Under Secretary for Health, Operations & Management (DUSH O&M) imposed a national moratorium on further purchase and implementation iMedConsent, pending resolution of these concerns and consideration of a possible national purchase of, a modified version of, iMedConsent. At that time, seven (7) VA facilities were already actively using iMedConsent and eight (8) more facilities had purchased, but not yet implemented the program. An additional 28 individual facilities and five (5) VISN offices were actively considering its purchase. The Health Systems Committee and the Informatics and Data Management Committee (IDMC) approved the Ethics Center's 6-month plan to work with other program offices and field advisory groups to make extensive modifications to the iMedConsent software to meet VHA-specific needs, and pilot test the modified product. In FY04, the VA purchased a perpetual license for the iMedConsent software product through the PCHS2 contract, with MPC as the prime contractor (Dialog Medical, subcontractor). The value of this order was $6,732,840, which included the license, development work of the software product to meet VHA specific needs, yearly software maintenance and implementation services at 162 hospitals, with a 16-month period of performance ending August 31, 2005 The VA currently uses the iMedConsent software program under a perpetual software license purchased in 2004. The iMedConsent software program is a forms management application integrated with VA's VistA platform. It allows for the processing of documents, signature capture, storage of signed documents, and communication with VA's VistA system. The VA receives bug fixes, enhancements and support services for the iMedConsent software program through a maintenance agreement. The VA also subscribes to Dialog Medical's Content Library. The content library contains thousands of procedure-specific consent forms, education materials and other documents useful for the informed consent process. These documents are used by the iMedConsent software program. Alternatively, the VA could choose to author and keep current its own content library for use with the iMedConsent software program. The VA considered this alternative and decided against it, opting instead to subscribe to Dialog Medical's content library. The subscription is annual. MPC modified the commercial off the shelf (COTS) software to work with VA systems. The VA version of iMedConsent has been modified to interface with VHA's computerized records system. The program enables practitioners to access a large library of documents, including drug information, patient instructions and anatomical diagrams and VA-specific documents such as VA Form 10-0137, VA Advance Directive. For treatments and procedures requiring signature consent, the program walks the practitioner through the various steps required by VA policy; provides help screens, reminders and policy links to encourage best practices; generates a customizable and patient-friendly electronic consent form; automatically populates consent forms with information specific to the patient and the selected treatment or procedure (from the iMedConsent library); incorporates signatures from an electronic signature pad; stores the consent form in the patient record; automatically generates an accompanying progress note in CPRS; exports selected data into a secure file to be used for quality improvement. Customization of the COTS software is not completed, however, once VA customization is complete, iMedConsent will include new wizards for advance care planning, HIV counseling and consent, and assessment of decision-making capacity. In FY05, the VA renewed the order with MPC through the PCHS2 contract in the amount of $3,166,792. This order included a yearly subscription, software maintenance and the development of the Spanish Content enhancement, with a 12-month period of performance ending on August 31, 2006. In-depth evaluation and pilot testing of the revised iMedConsent product provides compelling evidence that it satisfies VHA requirements on the following dimensions: technical; patient safety; acceptance by patients and practitioners; accuracy of clinical information; appropriateness of patient education materials; compliance with documentation requirements of VA policy; and unanimous endorsement by service chiefs and clinical application coordinators. In FY06, the PCHS2 contract vehicle expired and the VA purchased directly from Dialog Medical, a small business, in the amount of $2,509,435. This order included a renewal of the yearly subscription for English and Spanish content and software maintenance, with a 12-month period of performance ending August 31, 2007. Conducting an open market competition or pursuing any other competitive approach is not possible. The small business contractor, Dialog Medical, owns the Commercial-Off-the-Shelf (COTS) product with proprietary rights. There are no other sources or resellers of the standard maintenance of the COTS license and the modified version of the VA customized program. The software is proprietary to Dialog Medical and they are the only ones who own the source code. The incumbent contractor, Dialog Medical, has demonstrated their ability to provide an acceptable level of technical support of the critical functions. No other firm has the requisite knowledge and experience that can assume the very specific sustainment activities without interruption. Dialog Medical has the requisite number of key personnel possessing the required expertise for all the software applications needed for the day-to-day operations. Any break in Dialog Medical's support will result in systems failure, hardware and software, work stoppage and substantial additional costs in the amount of $12,409,067. Without this continued service in place, discontinuing this mandated initiative would cause significant clinical disruption and would compromise patient safety, given the degree of the software's implementation across the VA's health care system. 6. Efforts to Obtain Competition: Based on the fact that the iMedConsent program is of a proprietary nature, there are no efforts to obtain competition. 7. Best Value: The Contracting Officer will negotiate a fair and reasonable price with Dialog Medical to receive the best value for their product. 8. Market Survey: For more than two (2) years, individual facilities and several national program offices explored the use of computer technology to improve the process and documentation of informed consent. However, in March of 2003, the Health Systems Committee of VHA's National Leadership Board directed the National Center for Ethics in Health Care to work with other VHA national program offices and field-based experts to provide market research and thoroughly evaluate the desirability of national implementation of a computerized informed consent software product. A product called iMedConsent, by Dialog Medical, available to VA through MPC and the PCHS2 contract, was determined most appropriate for VHA. A presolicitation notice was issued on August 3, 2007, and no vendors have responded to date. 9. Other Facts: The original requirement was awarded competitively utilizing the PCHS2 contract vehicle. The requested award builds on Dialog Medical's development work completed to date. 10. Interested Sources: The original requirement was awarded competitively utilizing the PCHS2 contract vehicle. As previously discussed, a substantial duplicate investment of time and money would be required on the part of the Government and/or another contractor to get the Ethics Center's informed consent improvement initiative to its current position. There are no other sources or resellers of the standard maintenance of the COTS license and the modified version of the VA customized program. The software is proprietary to Dialog Medical and they are the only ones who own the source code. In addition, discontinuing this mandated initiative would cause significant clinical disruption and would compromise patient safety, given the degree of the software's implementation across the VA's health care system. 11. Steps to Increase Competition: There are no actions that can be taken to make the current requirement available for competition, without incurring substantial duplicate costs and experiencing unacceptable delays. In addition, FAR 17.207 requires the Contracting Officer to provide a written determination in order to justify that exercising the option is the most advantageous method of fulfilling the Government's need for continuity of operations and potential costs of disruption of operations. 12. Contracting Officer's Certification: The Contracting Officer's signature on the cover page certifies that the supporting data under my cognizance, which are included in this Other than Full and Open Competition Justification and Approval, is accurate and complete to the best of my knowledge and belief. 13. Technical Certification: The Program Manager's signature on the cover page certifies that the supporting data under his cognizance, which are included in this Other than Full and Open Competition Justification and Approval, is accurate and complete to the best of his knowledge and belief.
- Place of Performance
- Address: 810 Vermont St, NW;Washington, DC
- Zip Code: 20420
- Country: USA
- Zip Code: 20420
- Record
- SN01395248-W 20070907/070905220834 (fbodaily.com)
- Source
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