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FBO DAILY ISSUE OF SEPTEMBER 15, 2007 FBO #2119
MODIFICATION

D -- Launch a web-based Blood Glucose reporting system

Notice Date
9/13/2007
 
Notice Type
Modification
 
NAICS
518210 — Data Processing, Hosting, and Related Services
 
Contracting Office
Department of Health and Human Services, National Institutes of Health, Nat'l Institute of Diabetes, Digestive, & Kidney Diseases, 2 Democracy Plaza, Suite 700W 6707 Democracy Blvd., MSC 5455, Bethesda, MD, 20892-5455, UNITED STATES
 
ZIP Code
00000
 
Solicitation Number
NIH-NIDDK-07-291
 
Response Due
9/11/2007
 
Archive Date
9/26/2007
 
Description
ALL PREVIOUS AMENDMENTS ARE STILL IN AFFECT AMENDMENT: THE FOLLOWING STATEMENT IS INCLUDED IN THE STATEMENT OF WORK: The HHS Contractor Oversight Guide provides guidance for meeting policies identified in the HHS Information Security Program Plan and requirements mandated by the Federal Information Security Management Act (FISMA). In addition, NIH issued Information Security Acquisition Provisions to apply in the acquisition planning process and the NIH Chief Information Security Officer (CISO) further clarified FISMA guidance and the provisions of the Office of Management and Budget (OMB) Memorandum M-07-19, FY 2007 Reporting Instructions for the Federal Information Security Management Act and Agency Privacy Management. The FISMA requirement applies to ?information into any system which uses it or processes it on behalf of the agency.? HHS is also responsible for implementing and administering protection of information resources in compliance with applicable public laws, Federal regulations, and Executive Orders, including the FISMA; OMB Circular A-130, Management of Federal Information Resources, and the Health Insurance Portability and Accountability Act (HIPAA). Security specifications to the Statement of Work (SOW) for ensuring patient privacy and confidentiality include compliance with the provisions of ?Security Standards for the Protection of Electronic Protected Health Information? contained within 45 Code of Federal Regulations (CFR), Parts 160 and 164 to implement provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and associated NIH directives. See pages 10 and 16-18 for FAR Clause requirements. The Diabetes Division of NIDDK, as part of NIH and HHS, is responsible for managing the information and the inclusion of protected health information (patient data) requires completion of a Privacy Impact Assessment (PIA). References: U.S. Department of Health and Human Services (HHS), Contractor Oversight Guide, November 2006, including Appendix F, Information Security Solicitation Provision. - http://intranet.hhs.gov/infosec/docs/policies_guides/PIA/PIA_Guide.pdf 45 Code of Federal Regulations, Part 160, General Administrative Requirements, and Part 164, Security and Privacy - http://www.wedi.org/snip/public/articles/45CFR160&164.pdf The current acquisitions security clauses located on the NIH security site for FAR language concerning incorporation into contracts and see pages 10 and 16-18 for SOW input - http://irm.cit.nih.gov/security/IT-Security-Acquisition-Provisions.pdf????? Public Law 104-191, Health Insurance Portability and Accountability Act of 1996 (HIPAA) - http://www.hhs.gov/ocr/hipaa/ HHS Information Security Program, Privacy Impact Assessment (PIA) Guide - http://intranet.hhs.gov/infosec/docs/policies_guides/PIA/PIA_Guide.pdf This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation number is NIH-NIDDK-07-291 and is issued as a Request for Quotation (RFQ). The solicitation /contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2005-19. The North American Industry Classification (NAICS) Code is 518210 with a size standard of $23.0M. This is set-aside for Small Businesses. The National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has a requirement to procure the services of a contractor that is able to launch a web-based Blood Glucose (BG) reporting system. STATEMENT OF WORK Background The Diabetes Branch (DB) within the National Institute of Diabetes, Digestive, and Kidney Diseases? (NIDDK) Division of Intramural Research at the National Institutes of Health (NIH) has conducted several immunotherapeutic trials for patients with type 1 diabetes mellitus (T1DM), and has plans for other trials to initiate soon. For such trials, DB investigators collect data recorded by the patients including: ? Multiple daily ?finger stick? blood glucose (BG) checks from each protocol participant, including: o The time of day the BG was checked, o Whether the BG was obtained before or after a meal, or was due to symptoms prompting the BG check o For BG values that are either high, or low, whether that BG reading resulted in symptoms and the patient?s words describing those symptoms. ? Carbohydrates consumed, and the time of that consumption. For instance, carbohydrates might be consumed for meals or snacks, in response to a low blood sugar, or due to increased physical activity (i.e. in order to prevent a low that might be induced by exercise). ? Insulin doses administered. DB investigators train protocol participants to recognize the three reasons to administer insulin as: o Basal insulin- either via long-acting insulin injections or via an insulin pump o Meal associated insulin- typically using a preset insulin to carbohydrate ratio and o ?Sliding scale? insulin- administered using an algorithm-based dosing scale when the BG is unexpectedly high. This insulin is designed specifically to lower an elevated blood sugar whereas basal and meal-associated insulin is administered to prevent the BG from rising to abnormal levels. ? General comments including: o Exercise or other out-of-the-ordinary physical activity o Prescription medicines added to that individual?s regimen o Inter-current illnesses (likes colds or the flu) or other such unexpected ?stressors? that can influence glycemia control. o For those using insulin pumps, a site to record infusion set changes. o When appropriate, a site to record vital signs, height, and weight. That data is kept in a format easily understood by both protocol participants and study investigators, and is used as a tool to improve participant glycemia control. Study investigators can also analyze the data for protocol outcomes. The system we currently employ however has significant shortcomings including: 1. Records are maintained in Excel-based files that are sent by e-mail between the patient and the DB team. As such, the communication suffers from: a. Inadequate security re patient-record confidentiality, b. With chronic use and ever increasing data, the files become quite large. c. Patients must keep their records on their computer making the system less ?portable.? 2. Data analysis using our current format, while achievable, is not accomplished easily. 3. The current system does not allow for BG values to be directly downloaded from the various commercially available BG meters, and such manual data entry increases the chance for erroneous entries. Purpose The DB/NIDDK therefore wishes to partner with a company able to launch a web-based BG reporting system for use with future DB/NIDDK clinical trials. Objectives 1. To capture all that data currently recorded in the DB Excel based system, and structured such that the patients and the health care team can use the data to communicate in secure environment re therapeutic strategies to improve glycemia control. 2. For the BG readings in particular, the systems should support the electronic transfer of data directly from the BG meter into the web-based database. 3. For those BG meters that allow the patient to record meal-associated carbohydrate counts and associated insulin doses, (e.g. the OneTouch Ultrasmart monitor which already asks for the data), that data should also be appropriately downloaded into the web-based database. 4. Establish systems for NIDDK investigators to download the captured data into a database file (like Excel) so that data can be analyzed freely by DB/NIDDK protocol investigators. 5. Develop report screens suitable for clinical protocols, including a section for protocol participants to report adverse events. 6. The system must satisfy current criteria for protecting patient confidentiality. 7. The system must have appropriate backup systems to insure data will not be lost in the event of hardware system failure. 8. The system need have the capacity to store data from up to 1000 patients, and including up to 10 years of data for each patient. The contractor shall: Develop web based blood glucose reporting program, including procedures, timeline, training/education materials. 1. Develop Plan of Action 2. Identify relevant needs/objectives: as specified above i. Coordinate with the Diabetes Branch of NIDDK to facilitate the incorporation of the necessary objectives into the final product. 3. Provide training resources for the Diabetes Branch members who will be utilizing the system. 4. Deliver a product that has been tested and ready to use in the clinical environment, adhering strictly to the current privacy and confidentially requirements. 5. Work with the researchers in NIDDK to modify the product once delivered. 6. Provide continued product support. 7. Contractor must be knowledgeable about current health care policies regarding privacy. Project Deliverables a) Plan of Action b) Key processes flowchart c) Training resources for the staff d) A web based blood glucose management program that meets the objectives as specified above e) Continued support and training for the program Inspection and Acceptance Criteria Acceptance of work will be based upon the review of the Chief, Diabetes Branch, NIDDK. All deliverables and reports shall be inspected and approved by the Chief, Diabetes Branch, NIDDK. Project completion will culminate upon receipt and approval of all deliverables and the project briefing to the Diabetes Branch Chief, David M. Harlan, M.D., Captain, U.S. Public Health Service, Building 10, CRC Room 5-5940, Bethesda, MD 20892. Period and Place of Performance The work for this project will be performed both onsite at NIDDK and offsite at the contractor?s office. The period of performance will be Base Year plus Four (4) Option Years. The first year is the base contract which will include the product development/testing and production/maintenance periods. Special RFQ Instructions ? Quotation Submission 1. All Quotations must be submitted and received no later than September 11, 2007 3:00 P.M. Eastern Time. 2. All Quotations must not exceed 10 pages (this does not include any cost or GSA contract information or Resumes). 3. The pricing/cost proposal must contain sufficient information to allow the Government to perform a basic analysis of the proposed cost or price of the work. This information shall include the amounts of the basic elements of the proposed cost or price. These elements will include labor/personnel costs and items of other direct costs (e.g. materials, subcontracts, travel, etc.). 4. Provide a breakdown of labor hours, rates, and other direct cost by appropriate category. Key personnel will be identified. Give the basis for the estimates for each category. 5. Vendors must submit one original and three (3) copies of their respective Quotations. 6. The vendor may submit comparable information on all subcontractors that are proposed to perform a subcontract under this RFQ. 7. The vendor may provide information on problems encountered on the identified contracts/awards and corrective actions taken by the vendor. 8. Any quotation which fails to address all technical portions of the solicitation will be deemed non-responsive. Questions/Answers Any and all questions related to this RFQ should be submitted in writing to the attention of Ms. Patricia Haun electronically to haunp@mail.nih.gov no later than 3:00 PM local time, Thursday, September 5, 2007. Upon receipt of questions, the Government will provide all vendors with answers to all the questions submitted. Evaluation Factors for Award General Award of an order will be made to the vendor whose quotation is determined by the Government to represent the best overall value. Technical Evaluation The technical portion of your quotation is significantly more important than cost or price and will be receive paramount consideration for award. The technical portion of your quotation will be evaluated based on the evaluation criteria outlined below under ?Technical Evaluation Criteria?. The Government will evaluate the quality of the vendor?s past performance based on the information obtained from references provided by the vendor, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the vendor concerning problems encountered on the identified contracts and corrective action taken. Technical Evaluation Criteria for Proposal Please refer to the table at the end of this section for the scoring scheme that will be used to evaluate all proposals. A. Security (17 points) Provide a secure environment for patients to enter/download data and for patient-clinician communication. Proposals will be evaluated based on the vendors experience in constructing secure websites for handling confidential data. B. Blood Glucose Meter Data Download (17 points) The vendor will be judged on experience with downloading data from multiple BG meters. C. Website Design (17 points) Provide clear and usable graphical interfaces for data entry by patients. Data includes numeric measurements and textual communication. Proposals will be evaluated on general web programming experience and clarity in previous projects. Preference will be given to proposals demonstrating experience in diabetes-related clinical trial data. D. Data Extraction (17 points) The vendor must demonstrate appropriate programming capability to enable the download of accumulated data to clinicians (fellows, nurse practitioners, and their supervisors) and investigators in appropriate formats. E. Clinically-Oriented Reports & Graphs (6 points) Demonstrates experience with reports and graphs optimized for clinical management of diabetes. F. Flexibility in Report Structure (6 points) Special reports will be required to monitor the performance of individual care providers, display scientific data using particular search criteria, etc. For example, we may need to know: (1) How often does doctor X correspond with his/her diabetic patients? (2) How do patients followed by clinical team 1 do compared to patients followed by clinical team 2? (3) How many patients are being managed by each care provider? These and other questions can be formulated only after we have experience with the system. Therefore, the proposals will be evaluated based on the ability to develop and incorporate new reports. The use of a standard report writer is preferred. G. Flexibility in Database Structure (5 points) Ability to incorporate new tests/results as experience is gained with the system leading to constant system evolution and improvement. Proposals will be evaluated on the flexibility incorporated into the system. . H. Help Desk Support (5 points) Proposal must demonstrate clear plan and/or experience in providing continued product support in previous projects. I. Development and Production Periods (4 points) The year-long base contract will consist of an initial development/testing period followed by a production period. The vendor will specify a go-live date, which should be as early as possible while meeting the specified objectives. J. Cross-Browser Compatibility (4 points) Proposal should highlight adequate programming ability to attain cross-browser compatibility in the system. K. Formal User Feedback Procedures (2 points) The proposal must demonstrate a formal plan and/or experience in obtaining, tracking and incorporating suggestions for system improvements. These suggestions will originate from the NIDDK staff (as opposed to patients). Past Performance The Government will evaluate the quality of the offeror?s past performance based on information obtained from the references provided by the offeror, as well as other sources known to the Government. Evaluation of past performance will be a subjective assessment based on consideration of all relevant facts and circumstances. It will not be based on all standards of acceptable performance. The Government is seeking to determine whether the offeror has consistently demonstrated a commitment to customer satisfaction and timely delivery of services at fair and reasonable prices. Past performance will not be scored, but the Government?s conclusions about overall quality of the offeror?s past performance will be influential in determining the merits of the offeror?s proposal and in selecting the offeror whose proposal is considered most advantageous to the Government. By past performance, the Government means the offeror?s record of conforming to specifications and to standards of good workmanship; the offeror?s record of forecasting and controlling costs; the offeror?s adherence to contract behavior and commitment to customer satisfaction; and generally, the offer?s business-like concern for the interest of the customer, the offeror?s performance in clinically-related areas, The Government will consider the number of severity of an offer?s problems, the effectiveness of corrective actions taken, the offeror?s overall work record, and the age and relevance of past performance information. The lack of a performance record may result in an unknown performance risk assessment, which will neither be used to the advantage or disadvantage of the offeror. Past Performance Information: Vendors must submit a listing of the most recent contracts/awards (minimum of 3) which demonstrate similar work in nature to this Statement of Work. Contracts/awards may include those entered with the Federal Government, state and local governments and commercial concerns. Include the following information for each contract or subcontract: 1. Name of Contracting Organization, 2. Contract Number (for subcontracts provide the prime contract number and the subcontract number, 3. Contract Type, 4. Total Contract Value, 5. Description of Requirement and objectives 6. Contracting Officer?s Name and Telephone Number, and 7. Program Manager?s Name and Telephone Number. * If past performance questionnaire is available, please submit. The offeror must include a completed copy of the following provisions: 1) FAR Clause 52.212-1 Instructions to Offerors ? Commercial items; 2) FAR Clause 52.212-2, Evaluation ? Commercial Items. As stated in FAR Clause 52.212-2 (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be advantageous to the Government, price and other factors considered. 3) FAR Clause 52.212-3, Offeror Representations and Certifications ? Commercial Items; 4) FAR Clause 52.212-4, Contract Terms and Conditions ? Commercial Items; 5) FAR Clause 52-212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders ? Commercial Items ? Deviation for Simplified Acquisitions. The Dun and Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN) and the certification of business size shall be included. The clauses are available in full text at http://www.arnet.gov/far. PLEASE NOTE: In order to receive an award, contractor must be registered and have valid certification in the Central Contractor Registration (CCR) http://www.ccr.gov Interested vendors capable of providing the Government with the service specified in this synopsis should submit their quotation to the below address. Quotations will be due fifteen (14) calendar days from the publication date of this synopsis September 11, 2007 at 3:00 p.m. EST. The quotation must reference Solicitation number NIH-NIDDK-07-291. All responsible sources may submit a quotation, which if timely received, shall be considered by the agency. Quotations must be submitted in writing to the National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 6707 Democracy Blvd., Room 742, Bethesda, Maryland 20892, Attention: Patricia Haun. Faxed copies will not be accepted. Table 1: Scoring system for Evaluation of Proposals Data Collection for Diabetes Care and Clinical Trials (DCDCCT) Requirements Analysis Grid Requirement Basis of evaluation Maximum Final Rating A Security Experience constructing secure web sites for handling confidential data. 17 B Blood Glucose Meter Data Download Experience downloading data from BG meters of various brands. 17 C Website Design General web programming experience and clarity in previous projects. Preference will be given to proposals demonstrating experience in diabetes-related clinical trial data. 17 D Data Extraction Appropriate programming capability to enable the download of accumulated data to clinicians (fellows, nurse practitioners, and their supervisors) and investigators in appropriate formats. 17 E Clinically-Oriented Reports & Graphs Experience with reports and graphs optimized for clinical management of diabetes. 6 F Flexibility in Report Structure Special reports will be required to monitor the performance of individual care providers, display scientific data using particular search criteria, etc. These and other questions can be formulated only after we have experience with the system. Therefore, the proposals will be evaluated based on the ability to develop and incorporate new reports 6 G Flexibility in Database Structure Flexibility incorporated into proposed system design. 5 H Help Desk Support Clear plan and/or experience in providing continued product support in previous projects. 5 I Development and Production Periods Go-live date, which should be as early as possible while meeting the specified objectives. 4 J Cross-Browser Compatibility Demonstrates adequate programming ability. 4 K Formal User Feedback Procedures Formal plan and/or experience in obtaining, tracking and incorporating suggestions for system improvements. 2 100
 
Record
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