SOLICITATION NOTICE
L -- BIOSAFETY, BIOCONTAINMENT AND BIOSECURITY REVIEW SERVICES
- Notice Date
- 8/31/2004
- Notice Type
- Solicitation Notice
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy & Infectious Diseases/AMOB, 10401 Fernwood Drive, Suite 2NE70, MSC 4811, Bethesda, MD, 20817
- ZIP Code
- 20817
- Solicitation Number
- Reference-Number-RML-RFQ-4056
- Response Due
- 9/15/2004
- Archive Date
- 9/30/2004
- Point of Contact
- Julienne Keiser, Purchasing Agent, Phone 406-363-9370, Fax 406-363-9376, - John Foley, Contracting Officer, Phone 301-402-2284, Fax 301-480-0689,
- E-Mail Address
-
Jkeiser@niaid.nih.gov, jfoley@NIAID.NIH.GOV
- Small Business Set-Aside
- Total Small Business
- Description
- This notice 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; quotes are being requested and a written solicitation will not be issued. This procurement is being issued as a request for quotation. Submit offers on RML-RFQ # 4056. The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2001-24?dated 06/18/04. This acquisition will be processed under Simplified Acquisition Procedures (SAP) and is a Total Small Business Set-Aside. The North American Industry Classification System (NAICS) code for this procurement is 541690 and the small business size is $6.0. The Rocky Mountain Laboratories, Office of the Associate Director(OAD) is in need of Bio-safety, Bio-containment and Bio-security Review Services. After the events of September 11, 2001, and subsequent anthrax infections, President Bush tasked the National Institute of Allergy & Infectious Diseases(NIAID) to increase its research into the development of safe and effective counter-measures to protect the public against emerging infections and the threat of biological agents that could be used for bioterrorism. Towards achievement of the goals outlined in the NIAID Strategic Plan for Biodefense Research, the Division of Intramural Research(DIR), NIAID is required to construct and commission appropriate bio-containment facilities in the United States. An integral element of this priority initiative will be the development of procedures and processes to handle/monitor potentially lethal agents and to minimize the threat to the laboratory facility, its clinical/research personnel, and the surrounding community. The research studies/programs at the Rocky Mountain Laboratories (RML) are expanding to help develop new understanding, diagnostics, vaccines and treatments for infectious diseases, with priority emphasis on those relevant to bio-defense. To assure that research is carried out safely for both the scientists and the community, a new Integrated Research Facility (IRF) will be built on the RML campus. A relatively small portion of the IRF will contain Bio-safety Level (BSL) 4 laboratories, with the remaining space devoted to BSL-3 and BSL-2 laboratories, animal procedure and holding, offices and conference rooms. Through the design phase of the RML IRF project, NIAID DIR has drawn upon the expertise and experience of BSL-4 scientists, facility managers and bio-safety specialists. The engagement of these experts has led to a building design that will be a state-of-the art facility, and serve as a model, world-wide, for future high bio-containment facilities. In addition, RML has an existing state-of-the-art BSL-3 bio-containment facility, Building 25. Building 25 houses several research laboratory suites, a BSL-3 vivarium, and associated support functions. Several agents studied in the BSL-3 are on the Select Agent List. Building 25 will be linked to the IRF, and scientist access to Building 25 will be via the IRF. SCHEDULE: Integrated Research Facility: We are now at a crucial point in the process where we require the review and expertise of a Safety & Occupational Health Expert to develop the following: 1) Standard Operating Procedures for the IRF and associated Building 25 BSL-3 facility at RML; 2) Dedicated Bio-safety Manual for the IRF and associated Building 25 BSL-3 facility at RML; 3) Administrative tracking and monitoring procedures to insure compliance with regulations for work with select agents; 4) Training programs for the eventual management and operations of these facilities. Bio-safety, Bio-containment and Bio-security Review Services are required with the following requirements: 1) Provide Project Oversight and Review Services to evaluate bio-safety, bio-containment, and bio-security features for the RML IRF Facility: a) Evaluate construction, commissioning, operations and maintenance plans, specifications and procedures as developed by architects, engineers and other specialists on the project team; b) Develop written review comments representing NIAID DIR interests to other consultants, contractors, and federal staff involved with the project Delivery; c) When working with RML-IRF project team staff, facilitate the resolution of conflicts during the initial construction stages; d) Attend a wide range of meetings related to the IRF Project. 2) Coordinate and develop written Standard Operating Procedures (SOPs) for the RML IRF Facility based on established procedures and guidance defined by NIH organizations with jurisdictional authority. When addressing building matters, base SOP development on the Modes of Operations developed for the RML IRF project by the project team. The following organizational approach to the SOPs is suggested, but can be altered as needed: Overview of the SOPs within the context of the RML campus operations (administrative, security, laboratory, vivarium, waste, interface with other facilities, etc.) a) IRF Facility Operations and Maintenance (laboratory and vivarium); b) IRF Bio-safety, Bio-containment and Bio-security (laboratory and vivarium); c) IRF Protocol Specific (laboratory and vivarium) once researchers are identified. d) IRF Staff Security Clearance Process e) IRF Emergency Response. The following are minimum elements to be included within each SOP: i) Purpose for the SOP; ii) Responsible Parties; iii) Certifications required, if any, and the timing of those certifications; iv) Relevance of the SOP to other RML, NIH, DHHS, or federal requirements (radiation safety, security, legal, etc.); v) Step-by-Step Process and related procedures with flow diagrams included when applicable; vi) Organizational oversight, monitoring, review and update processes for the SOP; vii) Relevant documents required and location of those documents; viii) Any critical timing issues for implementation of the SOP. These SOPs need to be coordinated with the stipulations within the contract documents (drawings, specifications, commissioning, modes of operations, security and other contractual requirements) for the RML IRF project. Written verification of such coordination needs to accompany each segment of the SOP document. 3) Develop staffing and financial projections for operating the RML IRF. These should be based on the SOP Overview stipulations as defined above or modified based on the discussion and needs that arise in working with the Office of the Associate Director (OAD) at RML. In addition, confirm staffing levels against the planning projections stated in the Program of Requirements for the RML IRF. a) Determine RML IRF facility staffing functions for maintenance, animal holding, bio-safety and laboratory support. Provide recommendations regarding the feasibility of recruiting federal workers versus contract support; b) Determine the number of staff needed to operate the facility as defined by the Overview for the SOPs. Determine the timeline and requirements needed to hire and orient staff based on precursor requirements (i.e. clearances, availability, training, etc.). The primary staffing groups to be considered are listed as follows with added subsets of functional expertise for each as appropriate: i) Facility Maintenance; ii) Biosafety; iii) Security; iv) Animal Holding including animal care functions; v) Administrative; vi) Clerical Support. c) Develop training programs for RML IRF staff to ensure proper orientation for facility operations and research: i) Devise training programs for each of the functions and category of worker in accordance with SOP requirements. ii). Determine frequency of refresher training and specific levels of knowledge/expertise that many be required within the context of SOPs pertinent to that function. iii) Define certification requirements needed and the manner in which to obtain them. iv) Establish a training database used to monitor staffing expertise, training, and certifications. 4) Provide review services to representatives of local/regional medical facilities considered as to assist with developing appropriate capacity for emergency purposes for agents studied in IRF. The contractor shall develop a detailed plan for management of infections acquired in BSL-3 and BSL-4 facilities. The plan shall include requirements for facilities, equipment, supplies, staffing, and training necessary for a regional referral hospital to care for all patients. In developing this plan, the contractor shall work with local physicians, RML and NIH bio-safety staff, the RML infectious disease advisor, and hospital staffs. a) Involve hospital planning expertise as appropriate, given the review requested; b) Review written documents and plans as requested by such groups; c) Inform NIAID DIR staff of discussion and information provided. NIAID DIR may request that this information be provided via verbal discussion or written documentation depending on the topic and related issues. 5) Create presentations (Powerpoint, written, verbal) as required for various audiences requesting information about the RML IRF facility. These presentations need to be accomplished in accordance with NIAID DIR stipulations and approval before contacting outsiders. 6) Provide regular briefings to the OAD to ensure they are kept abreast of relevant information needed to be fully compliant with legal and regulatory matters associated with the RML IRF Facility, Building 25 and in general other operations as required within the RML campus (i.e. security). 7) Serve on RML Bio-containment Resources Steering Committee and RML Institutional Bio-safety Committee. 8) Provide review services to other RML medical and safety consultants as directed by RML Associate Director. Rocky Mountain Laboratories Campus Building 25: 1) Provide Project Oversight and Review Services to evaluate bio-safety, bio-containment, and bio-security features for the Building 25 BSL-3 Facility. a) Evaluate operations and maintenance plans, specifications and procedures; b) Develop written review comments representing NIAID DIR interests to consultants, contractors, and federal staff involved with the Project; c) Facilitate the resolution of conflicts concerning operations and maintenance; 2) Coordinate and develop written Standard Operating Procedures (SOPs) for Building 25 based on established procedures and guidance defined by NIH organizations with jurisdictional authority. Develop these SOPs such that employees within Building 25 can readily develop the appropriate management approach for operations. Since Building 25 is connected with the IRF Facility, cross referencing of information with the IRF is required in the areas where it is relevant. The following organizational approach to the SOPs is suggested, but can be altered as needed: a) Overview of the SOPs within the context of the RML campus operations (administrative, security, laboratory, vivarium, interface with other facilities, etc.); i) Building 25 Facility Operation and Maintenance(laboratory and vivarium); ii) Building 25 Bio-safety, Bio-containment and Bio-security (laboratory and vivairum); iii) Building 25 Protocol Specific (laboratory and vivarium) from research programs already assigned to the project. Work with the NIAID DIR Principal Investigators assigned to Building 25, Animal Program Director for NIAID DIR RML Campus and also other NIH organizations having jurisdictional authority regarding protocol SOPs; iv) Building 25 Staff Security Clearance; v) Building 25 Emergency Response within the context of the Bethesda Campus; vi) Minimum elements to be included within each SOP: 1) Purpose for the SOP; 2) Responsible Parties; 3) Certifications required, if any, and the timing of those certifications; 4) Relevance of SOP to other RML, NIH, DHHS, or federal requirements (radiation safety, security, legal, etc.); 5) Step-by-Step Process and related procedures with flow diagrams included when applicable; 6) Organizational oversight, monitoring, review and update processes for the SOP; 7) Relevant Documents required and location of those documents; 8) Any critical timing issues for implementation of the SOP. b) These SOPs need to be fully coordinated with the stipulations within the contract documents (drawings, specifications, commissioning, modes of operations, security and other contractual requirements) for the Building 25 project. Written verification of such coordination needs to accompany each segment of the SOP document. 2) Develop staffing and financial projections for operating the Building 25 facility based on the SOP stipulations as defined above. Determine Building 25 facility staffing functions for maintenance, animal holding, bio-safety and laboratory support. Determine the number of staff needed to operate the facility as defined by the SOPs. Determine the timeline and requirements needed to hire and orient staff based on precursor requirements (i.e. clearances, availability, training, etc.). The primary staffing groups to be considered are listed below with added subsets of functional expertise for each as appropriate: Facility Maintenance Bio-safety; Security; Animal Holding and Animal Caretakers; Administrative and Clerical. 3) Develop training programs for Building 25 staff to ensure proper orientation for facility operations and research: Devise training programs for each of the functions and category of worker in accordance with SOP requirements; Determine frequency of refresher training and specific levels of knowledge/expertise that many be required within the context of SOPs pertinent to that function; Define certification requirements needed and the manner in which to obtain them; Establish a training database used to monitor staffing expertise, training, and certifications. 4) Provide review services to representatives of local/regional medical facilities considered as to assist with developing appropriate capacity for emergency purposes for agents studied in Building 25. The contractor shall develop a detailed plan for management of infections acquired in BSL-3 and BSL-4 facilities. The plan shall include requirements for facilities, equipment, supplies, staffing, and training necessary for a regional referral hospital to care for all patients. In developing this plan, the contractor shall work with local physicians, RML and NIH bio-safety staff, the RML infectious disease advisor, and hospital staffs. Involve hospital planning expertise as appropriate given the review requested. Review written documents and plans as requested by such groups. Inform NIAID DIR staff of discussion and information provided. NIAID DIR may request that this information be provided via verbal discussion or written documentation depending on the topic and related issues. 5) Develop necessary modifications for operational matters that will need implementation when Building 25 and IRF are linked as a single facility. 6) Create presentations (Powerpoint, written, verbal) as required for various audiences requesting information about the Building 25 facility. These presentations need to be done in accordance with NIAID DIR stipulations and approval before contacting outsiders. 7) Provide routine briefings to the OAD at RML. 8) Serve on RML Bio-containment Resources Steering Committee and RML Institutional Bio-safety Committee. 9) Provide review services to other RML medical and safety consultants as directed by RML Associate Director. Deliverables: Written evaluation of current SOPs and Bio-safety Manual for Building 25 including recommendations for additions, corrections and other modifications. Written evaluation of proposed SOPs and Bio-safety Manual for IRF including recommendations for additions, corrections and other modifications. The government will provide an office on site and necessary equipment. The Contractor shall be required to complete on-line security training to insure compliance with RML IT security procedures and policies. The period of performance of this contract will consist of one(1) twelve month base period and four(4) twelve month option years and is estimated to begin 10/1/04 through 9/30/05, including the Government Option to extend as per FAR 52.217-9. This decision to extend will be made by the Government. If the Government exercises this option, a written notice will be sent to the Contractor sixty (60) days before the end of the existing contract period of performance. FOB Point shall be Destination, Hamilton, MT. Delivery location is Rocky Mountain Laboratories, 903 S. 4th Street, Hamilton, MT. 59840. The following FAR provisions and clauses apply to this acquisition: 52.212-1 Instructions to Offerors Commercial Items; FAR 52.212-2 Evaluation Commercial Items. This award will be based on the following evaluation criteria: The major evaluation factors for this solicitation include technical and cost/price factors, and past performance. Although technical factors are of paramount consideration in the award of this contract, cost/price and past performance are also important to the overall contract award decision. All evaluation factors other than cost or price, when combined, are significantly more important than cost or price. Contractors are advised that award will be made to that contractor whose proposal provides the best overall value to the Government. The evaluation will be based on the demonstrated capabilities of the prospective contractors in relation to the needs of the projects as set forth in this solicitation. The contractor must submit information sufficient to evaluate their proposals based on the detailed criteria listed in this solicitation. The qualifications of the contractor will be evaluated on the basis of past experience and accomplishments in managing multiple tasks related to high containment facility management including design, construction, commissioning, operation, maintenance, engineering and facility certification. Contractor must have provided review services to other Federal representatives with similar facilities at the Bio-safety 3 and 4 levels. The contractor shall provide a Curriculum Vitae or resume which identifies his/her experience which supports the contractors ability to provide the services identified in the Statement of Work. The qualifications of the contractor will be evaluated according to his/her knowledge of high containment research facilities; biomedical research laboratory practices and procedures; operations, certifications necessary and commissioning requirements for high containment laboratory facilities. Contractor shall also have knowledge of staffing requirements for these types of facilities. Contractor must have knowledge and experience in procedures and regulations related to select agent compliance. Contractor must have experience in conducting training programs related to biological safety in high containment laboratories. The Contractor shall have knowledge of all applicable regulations related to requirements for commissioning high containment biomedical facilities. Contractor must have experience in the development of standard operating procedures for high containment research laboratories, animal rooms and waste handling areas. FAR 52-212-4 Contract Terms and Conditions Commercial Items; FAR 52-212.5 Contract Terms and Conditions Required to Implement Statues or Executive Orders Commercial Items; FAR 52.246-4 Inspection of Services Fixed Price; FAR 52.227-14 Rights In Data General; HHSAR 352.224.70 (b)(f) Confidentiality of Information Clause. 52.237-1 Site Visit ? Offerors or quoters may request a site visit if needed, but not mandatory. 52.223-6 Drug Free Workplace; Offerors must include with their offer a completed copy of the provisions at FAR 52.212-3 Offerors Representations and Certifications Commercial Items. A Non-Disclosure Statement shall be signed by the Contractor; By submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the CCR database prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation. Offers may be mailed or faxed to the POC indicated above (Fax - 406-363-9376). Offers must be submitted not later than 4:30 PM (MDST) 9/15/04. Copies of the above-referenced clauses are available upon request, either by telephone or fax. All responsible sources may submit an offer that will be considered by this Agency.
- Place of Performance
- Address: Rocky Mountain Laboratories, 903 S. 4th Street, Hamilton, MT
- Zip Code: 59840
- Country: USA
- Zip Code: 59840
- Record
- SN00662009-W 20040902/040901034603 (fbodaily.com)
- Source
-
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