SOLICITATION NOTICE
D--D -- Research Study Management Software
- Notice Date
- 8/18/2005
- Notice Type
- Solicitation Notice
- Contracting Office
- Attn: Department of Veterans Affairs Medical Center, Acquisition and Materiel Management Service, (90CB), 10000 Brecksville Road, Brecksville, Ohio 44141
- ZIP Code
- 44141
- Solicitation Number
- 541-110-05
- Response Due
- 8/25/2005
- Archive Date
- 9/24/2005
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested and a written solicitation will not be issued. Solicitation 541-034-05 is issued as a Request For Proposal (RFP). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circulars (FAC) 2001-25. This is an unrestricted procurement for commercial items under the North American Industry Classification System (NAICS) Code 541511 and a Business Size Standard of $21.0 million per annum. The Louis Stokes Cleveland Department of Veterans Affairs Medical Center, Cleveland, Ohio is contracting for a company to provide competitive proposals for application software that best meets the requirements of Research Study Management Software. The system sought will provide electronic clinical, animal and basic study management capabilities throughout the project lifecycle, across all projects institution wide. The contract is effective for a one-year period from date of award. Technical and price when combined, are greater than past performance. Statement of Work: The functional and technical abilities required of the software include: 1 Ability to enter data utilizing a user-friendly system 2 Ability to add documents via scanner 3 Ability to interface with CPRS (our EMR) 4 Ability to track employees, their credentialing, education and training. 5 Allows employees to track their education and training. 6 Ability to track study progress, including number of subjects enrolled, withdrawn, complaints, new findings or any other relevant information about new risks, adverse events, protocol or consent changes or modifications, personnel changes, data safety reports, advertisements, investigator certification, and study deviations or violations 7 Ability to set up the flow for and run many committees. 8 Ability for electronic submissions to R&D, IRB, IACUC and other committees, if necessary 9 Uses logic branching 10 Ability to set agenda, modify agenda and change the order of review on the agenda for each committee meeting. 11 Ability for status updates r/t R&D, IRB, IACUC and contract/budget accompanied by dates and comments. 12 Ability for group e-mail notifications as necessary 13 Ability to generate a number of customized letters for each study and for each committee. 14 Ability to add new, replace or modify existing forms easily. 15 Ability to add and define fields as necessary 16 Ability to determine study visits via an event calendar over a lengthy study 17 Ability to enter electronic documents received from external or internal source into system for use. 18 Ability to allow multiple internal parties, based on security clearance, to access & view document at same time 19 Ability to allow multiple internal parties, based on security clearance, to access & view document while being altered. 20 Ability to document ongoing electronic "notes" attached to documents 21 Ability to establish document as "read-only" based on security level to prevent alteration 22 Ability to electronically store all communication (including transcripts of verbal communications) with linkage to related study 23 Institutionally defined ability to access and revise documents as necessary 24 Ability to allow multiple internal and external parties, based on security clearance, to access & view document at same time. 25 Ability to allow multiple internal and external parties, based on security clearance, to access & view document while being altered. 26 Ability to restrict viewing and/or editing of sensitive documents to designated individual(s) 27 Ability to provide document routing to support workflow for document review/completion 28 Ability to provide document change tracking 29 Ability to search/retrieve active files by key words 30 Ability to search/retrieve active files by names of responsible parties 31 Ability to search/retrieve active files by document category 32 Ability to search/retrieve active files by protocol number 33 Ability to provide institutional defined reports (specify reporting tools) 34 Ability to provide standard reports (describe) 35 Ability to search/retrieve archived files 36 Ability to generate and provide institutional defined reports from active documents 37 Ability to generate and provide institutional defined reports from archived documents 38 Ability to generate and provide institutional defined reports from active and/or archived documents 39 Ability to provide prompts to the user of a specific action to be taken or considered 40 Easily interfaces with current Microsoft programs, i.e., excel, access, etc. 41 A database format for patient medical history information to be captured for all specialties, whereby queries can be run and patients meeting study specific criteria will be identified. All patients who are referred to any study, from any specialty will then be saved and utilized for present and future clinical trials. 42 Ability to write a letter from same program and automatically send it out to all patients identified by above criteria and/or print labels that can be attached to recruitment information provided by the sponsor 43 Capability to enter patient demographics (including date of enrollment) 44 Ability to view all contracts, editions/amendments 45 Ability to provide status tracking of all contracts in the system 46 Ability to provide email capability directly from the application for contract and all related documents 47 Ability to provide email notification of contract milestones/expirations 48 Ability to archive documents at institution specified interval post-execution 49 Ability to provide duplicate checking for contracts for same services 50 Ability to scan hard copy contract received from external or internal source into system for use 51 Prepares and prints execution ready copies 52 Ability to build a research budget easily 53 Entire budget information to be automatically calculated when a payment milestone is reached (e.g., patient is entered into a patient-tracking log, data collection ends, final report issued, etc). 54 Budgeting programs for the department, investigator and program. 55 Stores budgets (or more optimally, the template calculated) 56 Generation of invoices / statements by trial 57 Forecast future revenue based from patients enrolled (assuming they will meet all benchmarks) 58 Ability to track expenses throughout the lifetime of the study or grant. 59 Ability to identify or flag patient charges as billable to various entities (the patient, the insurance company, the sponsor or to a VA research account) and print a report of this information to attach to a billing protocol. 60 Ability to track all the services a patient receives during a study visit and differentiate between those covered by the sponsor and those covered by the patients insurance. 61 Flexible fields to monitor the completion of various compliance documents required for each study: a billing checklist, the bill protocol and human subjects training 62 Ability to track patient visits with the ability to add in unscheduled visits or procedures or to not charge or delete procedures that were not done, that were supposed to be done on a particular visit. 63 Track procedures performed when they are outsourced to other departments or outside vendors, as well as the costs of these procedures so that received bills can be verified against internal records. 64 Print spreadsheets of all of the above, that will show earned revenue, expenses, income collected, revenue and with the ability to arrange the spreadsheets by: patient, study, specialty/department, all specialties/departments by year to date, month to date, etc?. 65 Provide flexible reporting of clinical and other sponsored research statistics, including volumes by services, PI, payment source, service provided and sponsor 66 Study Coordination of IRB submission, study management capabilities, appointment tracking/scheduling and screening procedures 67 Allow entry to be study specific, but w/ ability to run reports as either study specific or across trial categories (randomized or registry; drug vs. device, etc) 68 Ability to provide a centralized repository of contracts and related documents 69 Ability to provide a brief overview/summary sheet of contract information 70 Ability to provide secure access with unique identifier & password 71 Ability to provide secure document storage of finalized (executed) document to prevent any further document alteration 72 Ability to provide secure access by groups, roles and profiles 73 Ability to require password change on a regular basis 74 Ability for system administrator to easily update and access all user privileges 75 System administrator functions can be restricted by class of user 76 Ability to provide unique user authentication mechanisms within the system 77 Authentication data are encrypted 78 Ability to provide security levels for document access, view & alter 79 Ability to interface with a minimal computing environment, i.e., 1.5MHZ processor, 256MB RAM, 15 inch color monitor using 800X600 pixels. Describe the server environment that should be used for the software program. 80 Ability for export reports to a variety of formats, i.e., CSV, excel, etc. 81 Reporting functions need to be wizard driven, allowing users to create/modify their own reports, as well as a variety of ?canned? reports. 82 Annual support costs should be quoted for 24X7 and M-F 7AM-5PM EST 83 Ability to run on Windows 2000 and Windows XP. 84 Utilizes thin Web client that does not require application software on the desktop 85 Incorporates a centralized application repository so that anyone can logon anywhere to access all their data using their preferences 86 Utilizes servers for application controls, security, data storage, computation and database management 87 Accommodates up to 100 concurrent users without compromising response time 88 Provides an intuitive, graphical, multi-dimensional database administration environment. 89 Provides audit trail to identify the detail of each change to the database 90 Provides adequate backup, recovery and roll-back facilities 91 Supplies database administration and command reference guidelines including ?how to? instructions for accomplishing tasks 92 Ability to support 128-bit encryption for transfer of data over the Internet 93 Ability to work with Exchange 5.5 or higher. 94 Use of SSL V3 for ID/password client to application/database transport if over TCP/IP 95 System is HIPAA compliant 96 Ability to provide for maintenance of separate physical/logical environments for development, testing and production (ASP Application) 97 At least 2 programmers assigned to this project. 98 At least 1 support staff (help desk) are assigned to this Product. 99 The help desk is tiered. 100 At least 1 dedicated support person will be assigned to The VA. 101 The average response time/resolution time for help desk calls is within 1 hour during reg. Business hours. 102 At least 1 dedicated person will be assigned for implementation of the software. Evaluation Factors for Award: FAR 52.212.2 Evaluation ? Commercial Terms (Jan 1999) (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: Evaluation Factors (Listed in descending order of importance to the government): (1) Technical Capability (2) Price (3) Past Performance. Technical Capability/Experience: (3 copies of documentation required) The offeror shall provide evidence that the software can/: Support a minimum of 400 users Be Internet accessible Have a common database (ex. Oracle, IBM) Be HIPPA compliant Support any browser Support application services Be Java compatible Possess minimal hardware components Be a secured system HTTPS Ability to start on Sept. 1, 2005 The offeror shall provide one-time training with a study assistant module in place. Price: (3 copies of documentation required) Offeror shall provide pricing as requested in the schedule of supplies and technical requirements. Training costs should also be included. Past Performance: (3 copies of documentation required) The offeror shall provide a listing of all contracts performed with the last three years that are similar in nature and relevant to the efforts required by this solicitation. The Offeror shall furnish the following: a (Customer (Government of Commercial) and point of contact to include name, address, telephone number, fax number and email address for each contract, b. Service(s) provided including nature of contract, dollar value, etc., c. Description or relevance and similarity to the effort required by this solicitation. An offeror without a record of relevant past performance or for whom information on past performance is not available or incomplete will be given a ?neutral? rating for past performance. An offer with an unsatisfactory past performance rating is not eligible for award. NOTE: The Government reserves the right to award without discussions; therefore submit your most favorable terms with your quote. Options: The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful Offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer?s specified expiration time, the Government may accept an offer (or part of an offer) whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. Invoices shall be submitted in accordance with Federal Regulations 52.212-4(g) and shall be submitted to Financial Management Systems, PO Box 149971, Austin, Texas 78714. Remittance address: payments under this contract shall be made to the address indicated in your quote. The provisions at FAR 52.212. -1, Instructions to Offerors-Commercial Items, applied to this acquisition with the following addendum to the provisions, delete paragraph e and h of the standard provisions. Offerors shall submit with their offer, a completed copy of the provisions at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items. The clause at 52.212.4 Contract Terms and Conditions?Commercial Items, applies to this acquisition, to include the following addendum to the clause; 52.217-8 (which provides that the Contracting Officer may exercise the option by written notice to the contractor within 30 days); 52.232-18, 52.232-19 (which provides that funds are not authorized past September 30, of any fiscal years, unless written authorization is received from the Contracting Officer) 52.233-3, VAAR clause 853.233-70, 852.233-71, 852.237-70, 852.270-1, 852.270-4. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders?Commercial Items, applies to this acquisition which shall include the following clauses: 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.225-3 Alternate I, 52.225-13, 52.232-34, 52-222-41, 52.222-42. The preceding Federal Acquisition Regulations (FAR) clauses and provisions may be accessed on the Internet at http://www.arnet.gov/far. The preceding Veterans Administration (VAAR) clauses and provisions may be accessed on the Internet at http://www.va.gov/oa&mm/varr/. Offerors shall submit their quotation along with the completed copy of FAR 52.212.3 Offerors Representations and Certifications?Commercial Items. The Service Contract Act applies to this acquisition and the Wage Determination in effect for this acquisition is Wage Determination No. 1994-2415/revision No 26 dated 6/21/2004. Offeror shall submit all technical questions regarding this solicitation to the Contracting Officer in writing, no later than Aug. 23, 2005. Questions may be sent via facsimile at 440-838-6052 or by e-mail to Eric.Rhodes@med.va.gov. Verbal questions will not be addressed. All responses to questions that may affect offers will be incorporated into a written amendment to the solicitation. Proposals are due no later than 2:00 pm., EST Aug. 25, 2005. The successful offeror must be registered with the Central Contractor Registration (CCR) to be awarded a contract. You may register easily and quickly on-line at https://www.ccr.gov.
- Place of Performance
- Address: Louis Stokes Cleveland, VAMC, 10701 East Blvd, Cleveland, Ohio
- Zip Code: 44106
- Country: United States
- Zip Code: 44106
- Record
- SN00873579-W 20050820/050818212101 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |