SOLICITATION NOTICE
99 -- Institutional Animal Care and Use Committees (IACUC)
- Notice Date
- 9/12/2007
- Notice Type
- Solicitation Notice
- NAICS
- 813920
— Professional Organizations
- Contracting Office
- Department of Veterans Affairs;VA Central Office;Acquisition Operations Service (049A3);810 Vermont Avenue, NW;Washington DC 20420
- ZIP Code
- 20420
- Solicitation Number
- VA-101-07-RQ-0408
- Response Due
- 9/17/2007
- Archive Date
- 11/16/2007
- Small Business Set-Aside
- Total Small Business
- Description
- RFQ VA-101-07-RQ-0408 Combined Synopsis/Solicitation Institutional Animal Care and Use Committee (IACUC) This is a combined/synopsis solicitation for commercial services prepared in accordance with the format in FAR 12 and 15, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are requested and a written solicitation will not be issued. This solicitation will incorporate provisions and clauses that are in effect through Federal Acquisition Circular 01-04. The North American Industry Classification System code is 813920 with a standard restriction of $6.5 million. The contractor shall provide all necessary labor, materials and equipment required to MONITOR AND EVALUATE HOW CONSISTENTLY THE VETERANS HEALTH ADMINISTRATION (VHA) IACUC'S MEETS THE REGULATORY AND FUNCTIONAL RESPONSIBILITIES GIVEN IT BY VA POLICY AND FEDERAL REGULATIONS. The following is an overview of the Statement of Work (SOW). Please contact Corinthia Price at corinthia.price@va.gov for a copy of the SOW. You must include in your request the Request for Quote (RFQ) number and the title. Consistent with its critical role as the institution's self-regulatory body, each institutional IACUC has the following basic charges: " Uphold and maintain the tenets of the most current Department of Veterans Affairs Handbook governing animal research (1200.7), the USDA Animal Welfare Act Regulations (AWAR), and the Public Health Service (PHS) policies. " Provide impartial initial review of any protocol involving the use of animals within the institution. " Provide reviews of all modification requests to established and approved protocols involving the use of animals. " Provide assurance that staff and investigators are trained in current best practices in laboratory animal management and the humane care and use of laboratory animals. " Assure that all staff coming into contact with research animals are protected through a current and comprehensive occupational health and safety policy. " Provide a comprehensive, semi-annual review of the programmatic and physical infrastructure, including all locations which may be used to conduct VA animal research or house VA research animals. " Review and approve Standard Operating Procedures for the animal research facility. " Interpret and provide guidance to local research staff on any regulatory questions or concerns. " Respond to all animal research related concerns on a station level. " Provide aid and assistance to the staff veterinarian, animal facility staff and Institutional Review Board (IRB) members on any animal or regulatory matter brought before the board, to include issues of potential mistreatment and protocol noncompliance. " Provide reports and feedback to the hospital Director regarding the state of the program and any corrective measures needed to ensure quality and compliance. Both VA policy (found in Handbook 1200.7) and the AWAR and the PHS Policy describe specific authorities and responsibilities for the IACUC. VACO and the CVMO make all efforts to monitor all elements of a stations research program. Collectively however, these efforts have a weakness in that they only represent "snapshots" of IACUC function at points in time, and do not necessarily evaluate the ability of an IACUC to sustain a level of local monitoring and oversight needed to ensure a consistently high quality program. Specifically, they do not allow VACO to evaluate the IACUC's ability to complete an entire monitoring "cycle" (identify problems, identify solutions and corrections, and ensure the timeliness and effectiveness of corrections) nor evaluate if the IACUC's documentation of business conducted at meetings and documentation available for specific projects is adequate. Such evaluations are difficult to perform without on-site evaluations. Accordingly, the general scope of this contract is an evaluation of how consistently the IACUC meets the regulatory and functional responsibilities given it by VA policy and federal regulations. Consistent with the concept of self-regulation, the IACUC must: 1.6.1 Review proposed uses of animals and ensure that such use is consistent with policies and regulations, and document the review in minutes and other documents to provide confidence that adequate review is being performed. 1.6.2 Monitor ongoing animal research to ensure that studies are being conducted as approved, and document monitoring activities. 1.6.3 Identify deviations from policy and regulation, document them, develop a corrective plan and timeline, then monitor to ensure that corrective actions have been effective and timely. 1.6.4 Communicate with both investigators and the medical center Director as needed to ensure transparency and foster an environment where self-regulation can be optimally effective. 1.7.3. The overall goal is for the contractors to get a sense of: A. IACUC organization and general management; Level of IACUC effectiveness in the review of investigator requests for use of animals in biomedical or rehabilitative research within the VA B. Level of IACUC effectiveness in the management of new and on-going investigator requests for use of animals in biomedical or rehabilitative research within the VA C. Level of IACUC effectiveness in monitoring the overall animal research program. D. Level of IACUC effectiveness in monitoring the animal research facility (both infrastructure and physical assets). E. Level of IACUC effectiveness in the identification of programmatic and facility deficiencies. F. Level of IACUC effectiveness in the formulation and execution of plans for corrective action toward identified deficiencies. G. Level of IACUC effectiveness in response to issues involving both the animal program, the users of the program or over-arching issues with biomedical research involving animals. H. Level of IACUC knowledge in current best practices and regulations involving animal programs. 1.7.4 Reporting. These reports shall be due no later than three (3) weeks after each site visit has been concluded. Reports which are not received within eight (8) weeks after site visit shall be considered seriously delinquent and may endanger the remaining completion of the contract. The contract shall be completed and all reports delivered to the Director, Biomedical Laboratory Research and Development Service (121) no later than eighteen months (18) from the date of first document submission request. If IACUCs or Medical Centers do not provide relevant documents in a timely fashion, the VA, Biomedical Laboratory Research & Development Service will provide assistance in the gathering of requested background materials. The following deliverables will be expected by the VA: 2.1 The contractor will gather applicable materials for a pre-review of internal IACUC processes (these materials will include items described in section 1.7.1 plus others as deemed appropriate by the contractors) 2.2 The contractor will review requested materials, determine site visit timeframes and assemble an appropriate visit team to address issues below: 2.2.1 Internal Functioning and Management of the IACUC: 2.2.1.1 Appropriate management processes and internal controls for the IACUC. 2.2.1.2 Project Management and planning performance for both the IACUC and the animal program. 2.2.1.3 Project Management and planning performance for occupational health and training. 2.2.1.4 Ratio of successful conversions from metrics and written regulations to program functionality. 2.2.1.5 Demonstration of successful and clearly defined relationships with internal and external review groups (Research and Development Committee, Biosafety Committee, Medical Center Radiation Safety Committee, CVMO, AAALAC and any affiliated institutions). 2.2.2 IACUC review and monitoring of hospital functions shall include, but not be limited to: 2.2.2.1 Appropriate review and monitoring of the animal facility physical plant (to include off-site labs and research holding areas). 2.2.2.2 Appropriate review and monitoring of the animal facility assets (personnel, capitalized and non-capitalized equipment and station support staff) 2.2.2.3 Appropriate review and input into costing practices (primarily review of per diem setting practices). 2.2.2.4 Appropriate review and monitoring of study and programmatic documentation. 2.2.3 Evaluation and Review Functions will include, but not be limited to: 2.2.3.1. Review of compliance with all VA and Federal regulations 2.2.3.2 Review of compliance with all industry standards (i.e. Association for the Assessment and Accreditation of Laboratory Animal Care International, American Association for Laboratory Animal Science and other groups.) 2.2.3.3. Evaluation of understanding and responsiveness to changes in Industry Standards. 2.2.3.4. Evaluation of understanding and responsiveness to changes in regulatory requirements. 2.3 Once the site visit has been performed, the team will be responsible for providing to the VA a final document on findings and recommendations. 2.4 Upon completion of ALL site visits the contractor will provide a summary document which will detail the programmatic trends and suggested corrections, if any. 2.5 This final summary document MUST be submitted within eight (8) weeks from the date of final site visit. 2.6 All materials collected during the course of the site visit preparations are the property of the VA and must be handled in a confidential and secure manner. The contractor must outline in their response, planned methods for handling and securing of paper and electronic documents. 2.7 All materials and reports generated during the course of the contract will become the sole property of the VA. 2.8 All materials collected and generated during the course of the contract will be returned to the VA for either destruction or appropriate records management. IACUC Evaluation Factors In reviewing any bids or proposals the following elements must be evaluated, in lieu of sole use of best price. Technical merit- The vendor must be able to demonstrate through recent projects/programs that perquisites knowledge, skills and abilities in monitoring Institutional Animal Care and Use Committees (IACUC) exist. The vendor must also be able to demonstrate a current working knowledge of all appropriate federal and industry regulations pertaining to Animal Research and IACUC composition. 1. Provision of redacted (non-identifiable) reports and recommendations of IACUC activities. These reports should indicate deviations or support of regulatory compliance factors. 2. Provision of planning and timelines for workload accomplishments. 3. Provision of letters of recommendation from prior clients. 4. Provision of resumes for proposed work team. Price- The vendor must be able to demonstrate that pricing will provide competitive advantage to the government. Adherence to schedule- The vendor must be able to demonstrate their ability to adhere to established schedules. The clauses 52.212-1 Instructions to Offerors - Commercial Items, 52.212-3 Offeror Representations and Certifications - Commercial Items, 52.212-4 Contract Terms and Conditions - Commercial Items and 52.212-5 Contract Terms and Conditions to Implement Statutes or Executive Orders - Commercial Items apply to all items in this acquisition and are attached for your review.
- Record
- SN01403940-W 20070914/070913072421 (fbodaily.com)
- Source
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