SOLICITATION NOTICE
R -- Consulting Services
- Notice Date
- 9/17/2005
- Notice Type
- Solicitation Notice
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- Reference-Number-10033291007541
- Response Due
- 9/22/2005
- Archive Date
- 10/7/2005
- 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 and a written solicitation will not be issued. This synopsis, identified as No. 1003329 & 1007541, is to notify contractors of the government?s intent to award a purchase order to Mead Walker Consulting under the simplified acquisition procedures. The FDA intends to issue a simplified acquisition on a sole source basis to Mead Walker Consulting, 1199 Hope Well Rd, Downingtown, PA 19335-1206. There is only one responsible source and no other supplies or services will satisfy agency requirements due to the following reasons: The FDA has worked with Mead Walker for approximately two years to develop the HL7 Individual Case Safety Report (ICSR) Message. Mead has extensive experience with HL7, and is one of two experienced modelers in HL7 that has direct, relevant experience with developing messages for the HL7 Public Health Reporting Domain. Mead has worked extensively over the past 2 years with FDA and CDC, specifically in the area of public health surveillance. Mead is uniquely qualified, in that he already has thorough knowledge and experience with developing a message that supports FDA regulatory and surveillance program requirements for CDER/CBER?s Adverse Event Reporting System (AERS), CDRH?s Manufacturer and User Facility Device Experience Database (MAUDE), and FDA/CDC Vaccine Adverse Event Reporting System (VAERS). Mead understands FDA?s business processes and analysis requirements for adverse event data reported to the agency, and well as other regulatory requirements, such as stability data industry submissions that support new drug applications or biologics license applications. Mead produces excellent work products, as has successfully coordinated the ballot and approval of two public health standards: Disease surveillance (Case Notification) and Adverse events (ICSR). Both standards are ANSI approved. Mead?s ability to translate FDA requirements into HL7 modeling language is exceptional, and has contributed to the overall success of our work. The learning curve for a new contractor to understand HL7 modeling, the ICSR message standard, the International Conference on Harmonisation?s E2B message specification, and FDA business processes is substantial. The FDA Data Standards Council (DSC) would like to minimize the amount of ballot fatigue and resource commitment necessary to orient and train a new contractor. The DSC AE Workgroup will also be engaged in extensive planning and system development to implement the existing ICSR message and create an FDA implementation guide. This concurrent work will greatly reduce the amount of time and assistance that can be devoted to bringing a new contractor up to speed on the standard and our goal to consolidate AE reporting formats within the agency. Mead?s work with FDA has already provided him with an opportunity to have some preliminary discussions with CVM about specific requirements for accommodating their products, and Mead previously received CFSAN database tables for preliminary review over a year ago. Mead?s understanding of how AERS, VAERS, and MAUDE accepts, processes and archives data will contribute greatly to his efforts to migrate CFSAN data into the existing model structure, and given his extensive work with both FDA and CDC, the DSC is confident that Mead will do an outstanding job, and is better positioned to work more independently to develop the necessary requirements analysis documents, and HL7 project descriptions and ballot materials. Mead has worked with HL7?s Information Exchange for the last four years, he has been intensely involved with Version 3 implementation projects at CDC and the FDA. Mead Walker has also worked with Oracle in the creation of their V3 implementation guides. Mr. Walker?s work has also included creating draft Vital Statistics messages for the National Center of Health Statistics (NCHS), Version 2 implementation guides for laboratory results reporting (CDC BioTerrorism) and immunization registries (National Center for Infectious Disease (NCID)). While working at Shared Medical Systems, Mead Walker was involved with coordinating that vendor?s use of HL7 messages, and actively worked in documenting the use of X12 standards to support Patient Eligibility Inquiries and Reports. Creating useful written documents has been a critical aspect of Mr. Walker?s work in healthcare data processing since 1984. Mead Walker has developed functional design documents and participated in documentation of a corporate data model at Shared Medical Systems (now Siemens), has acted as the editor of the Message Development Framework for HL7 Version 3, and developed V3 Implementation Guides for CDC and Oracle. These reasons, considered in their entirety, why FDA anticipates a sole source award to Mead Walker Consulting, however, other sources may submit descriptive literature that fully demonstrates their capabilities and they will be reviewed to determine if they are considered qualified. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2001-27. The associated NAICS code is 541690 ?Other Scientific and Technical Consulting Services and the small business size standard is $6M. The following are objectives and tasks Mead Walker Consulting will be requested to provide: Objectives: To develop a standardized, structured electronic message and ballot documentation for representing complex Individual Case Safety Reports and protocol information to be balloted at Health Level 7. To reconcile the messages with the HL7 RCRIM Domain Analysis Model (DAM) (S.2). Task: 1. Extend ICSR to support food and animal drug related reporting. 2. ICSR Implementation Guide Development. 3. Extend RCRIM Domain Analysis Model. 4.Provide education on HL7 and messaging standards to FDA. Task 1: Activity: Review requirements for data, create mapping between data requirements and ICSR, prepare proposal for ICSR updates (if needed), and work within HL7 to get updates through the balloting process. There will be deliverables with scheduled due dates. Task 2: ICSR Implementation Guide Development, which includes: 1. Define which model contents are to be supported. This includes classes, associations and attributes. 2. Determine strategy for object identifiers (OIDs). 3. Identify vocabularies to be included. Create proposals as needed for HL7 domains and value sets, and LOINC codes. 4, Create draft Implementation Guide document, drawing on, where possible, existing HL7 and CDC guides. 5. Carry out internal document review and update document. 6. Submit Implementation Guide to HL7. Task 3: Extend RCRIM Domain Analysis Model (DAM) (S.2). The following effort will be required for the items discussed above. Note, work on this task is predicated upon the promised publication of the RCRIM Domain Analysis Model, which includes: 1. Review and understand published DAM. 2. Assess and propose approach to DAM development. 3. Provide class level mapping to the ICSR. 4. Document proposal for DAM extension. 5. Work with RCRIM to have model extensions enabled. Task 4: Provide Education on HL7 and Messaging Standards to FDA, which includes providing educational sessions for FDA staff where requested. There will be deliverables with scheduled due dates. Period of performance is one year from date of award. The provision at FAR 52.212-1, Instructions to Offerors?Commercial Items applies to this solicitation. The following agenda have been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications?Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions?Commercial Items applies to this acquisition. The following agenda have been attached to the clause: None. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders?Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, FAR 52.225-3, FAR 52.225-15, FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition. The FDA intends to make award immediately following the response date on this notice. All responsible sources that intend to submit descriptive literature shall submit it by COB on the due date referenced above to the following address or e-mail: Food and Drug Administration, 5630 Fishers Lane, Room 2083, HFA-500, Rockville, Maryland 20857-0001 or Lforgosh@oc.fda.gov. The Government will award a firm-fixed-price purchase order using Simplified Acquisition procedures in accordance with FAR 13.5. For information regarding this solicitation, please contact Lori Forgosh at 301-827-7044, fax 301-827-7106 or e-mail Lforgosh@oc.fda.gov.
- Place of Performance
- Address: 1199 Hope Well Road, Downingtown, PA
- Zip Code: 19335-1206
- Country: USA
- Zip Code: 19335-1206
- Record
- SN00897863-W 20050919/050917211532 (fbodaily.com)
- Source
-
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