SOURCES SOUGHT
A -- Study of Women’s Health Across the Nation (SWAN) Biospecimen Repository
- Notice Date
- 6/24/2010
- Notice Type
- Sources Sought
- NAICS
- 621991
— Blood and Organ Banks
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Mental Health, Contracts Management Branch, 6001 Executive Blvd, Rm 8154, MSC 9661, Bethesda, Maryland, 20892-9661
- ZIP Code
- 20892-9661
- Solicitation Number
- HHS-NIH-NIDA(AG)-SBSS-10-131
- Archive Date
- 7/24/2010
- Point of Contact
- Rosanne S Wilson, Phone: 301-443-4433, Suzanne Stinson, Phone: 301 443 4116
- E-Mail Address
-
wilsonr@mail.nih.gov, sstinson@mail.nih.gov
(wilsonr@mail.nih.gov, sstinson@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice." BACKGROUND The National Institute on Aging (NIA) continues to have a need for collecting, storing, monitoring and distributing, serum, plasma, urine and DNA for the Study of Women's Health Across the Nation (SWAN) Biospecimen Repository. SWAN is an ongoing multi-ethnic longitudinal study conducted by seven (7) clinical field sites, a data coordinating center and a central laboratory. It is designed to characterize the physiological and psychosocial changes that occur during the menopausal transition and beyond. SWAN has an extensive base of well characterized data and a repository of biological specimens from 3,300 African American, Chinese, Caucasian, Japanese and Hispanic women with over twelve years of annual follow-up visits that describe the endocrinology of the transition and other factors relevant to midlife health and aging. The women, whose age ranged from 42 to 52 years at enrollment in 1996-97, will continue to be followed until they are 59-69 years old under an existing grant mechanism (separate from this Biorepository requirement) which expires in 2014. SWAN has the capability to link the expansive biological, medical, social, behavioral, and demographic data it has collected over sixteen years to the development of both positive and adverse health conditions in early old aged women. The major thematic areas include 1) Physical Functioning; 2) Bone/Osteoporosis; 3) Cognitive Function/ Symptoms/ Mental Health and 4) Diabetes/Cardiovascular disease. New domains for SWAN include physical performance and osteoarthritis, history of major depression, and carotid wall thickness. Frozen biospecimens from the seven (7) SWAN clinical field sites are currently housed in sixty-five (65) 80oC mechanical freezers at SeraCare Life Sciences located at 8425 Progress Drive, Frederick, Maryland. The SWAN Biorepository has accrued 1.7 million samples of serum, plasma, urine, and DNA that were meticulously collected and managed from 3,302 women from five race/ethnic groups followed annually prior to, during and after the menopausal transition. The SWAN Biorepository is an integral arm of SWAN intended to support (the collection, processing and storage of new specimens from the ongoing study), and, by disbursing specimens to investigators for analyses, facilitate and extend the SWAN core study to allow the efficient evaluation of new and untested existing hypotheses. SWAN will continue participant follow-up visits and longitudinal data collection between 2010 and 2014. As a result, it is anticipated that an additional 113,792 new serum, plasma and urine samples will be generated for the SWAN repository. Since 2000, the biospecimen repository has been supported by a National Institutes of Health (NIH) research project grant mechanism (to the University of Michigan) separate from the SWAN clinical fields sites, coordinating center and central laboratory. This requirement shifts the SWAN Biorepository instrument from a grant to a contract mechanism. PURPOSE AND OBJECTIVES The purpose of the SWAN Biorepository is to provide a resource designed to receive, store, catalog, preserve and distribute specimens to qualified investigators. The SWAN Biorepository is needed to 1) support collection and storage of biological specimens from planned follow-up visits in the ongoing SWAN study; 2) provide for the continued management of the current repository specimens; 3) provide for the continued administration of the review process for applications for specimen use and management of specimen distribution; and 4) develop strategies to promote utilization of specimens. Description of Duties for the Biospecimen Repository, The Contractor shall perform the tasks specified below to support the aforementioned needs as directed by the NIA Contracting Officer and Contracting Officer's Technical Representative (COTR). The Contractor shall provide Quality Assurance/Quality Control procedures for prospective monitoring and evaluation of short and long term specimen management, including identification and removal of non-useful specimens and refinement of specimen cataloging. The Contractor shall follow all federal and State requirements and current best practices for the collection, storage, cataloguing, retrieval and distribution of biological material for scientific research. The Contractor shall also follow the SWAN Biorepository Operational Guidelines for acquiring and distributing biospecimens. PROJECT REQUIREMENTS The specific tasks will include: (1) Project Management, the Contractor shall provide a technical and administrative infrastructure to ensure the efficient planning, initiation, implementation, and management of all performance requirements contained in the Statement of Work (SOW) and ensure effective communications with the NIA COTR and Contracting Officer. This infrastructure shall include a Principal Investigator with responsibility for 1) overall project management and communications, tracking, monitoring and reporting on project status and progress, and 2) recommending modifications to project requirements and timelines, including contract requirements performed by any subcontractor(s). This infrastructure shall also include a Project Manager to coordinate Biorepository activities conducted under this contract; and administrative staff with responsibility for financial management and financial reporting on all activities conducted by the Contractor and any subcontractor(s). The Contractor shall administer the fiscal resources of the Biorepository; manage all activities related to the negotiation, distribution, and recovery of resources, including Material Transfer Agreements (MTA) and data recovered under the MTA; manage the Biorepository and its resources in a manner consistent with ethical procedures prescribed by the Institutional Review Board, while meeting the requirements for data sharing and resource distribution, including the genetics material and data; assure that activities are consistent with best repository practices (codified by the International Society of Biological and Experimental Repositories-ISBER); and administer the application process for scientists wanting to use Repository specimens and data resources. (2) Storage Facilities and Equipment, the SWAN Biorepository specimens are currently housed at SeraCare Life Sciences in 65 freezers purchased by the University of Michigan (using government funds from a grant supporting the SWAN Repository). In order to avoid redundant freezer and relocation costs and unacceptable risk to these highly perishable and irreplaceable biological specimens, the Contractor shall provide sufficient space for freezers at SeraCare Life Sciences located at 8425 Progress Drive, Frederick, MD to store and maintain biologic specimens collected from 3,300 SWAN participants from 1996 to the present. The Contractor shall obtain services from, and manage the subcontract with, SeraCare, which will physically house, operate and maintain the SWAN Biorepository Specimen and Electronic Inventory. The Contractor and Subcontractor shall maintain high quality storage and inventory for an estimated 1.7 million specimens of plasma, serum, urine, whole blood samples, immortalized cells and extracted DNA (including 578,000 serum, plasma and urine samples collected from annual visits; 26,000 DNA samples; and one million urine samples from the Daily Hormone Study (DHS) in which participants collected urine samples daily for one entire menstrual cycle per year). An additional 113,792 specimens will be collected from SWAN participants at follow-up visits during the current project period which ends in 2014. The facilities provided shall enable expansion of the SWAN Biorepository over the period of the contract. It is estimated that an additional five (5) -80oC freezers (comparable to the profile, capacity and quality of the existing freezers) will be needed to house new samples collected between 2010 and 2014. The Contractor shall ensure that an adequate number of empty, functional storage units, are available to serve as back-up units in the event of freezer failure. (3) Data Management Systems, (A) SWAN Biorepository Website, The Contractor shall maintain and enhance the "SWAN Data Warehouse", a searchable, concept-driven website to promote understanding of the SWAN Study and its data and biospecimen resources, provide access to SWAN data and support all repository utilization functions by: Generating a content-driven MeSH (Medical Subject Headings) matrix that is linked to SWAN publications and descriptions of the nature and scope of existing SWAN data ; Providing detailed information about the data and assay methodologies and publication history to SWAN investigators, requestors of samples and the scientific community; Providing access to necessary protocols, forms, and technical assistance documentation; and Incorporating a "report-generator" function for efficient electronic building of codebooks and datasets. In addition, the website shall provide a secure point of access for authorized users of the specimen inventory and request management system. The system user manual, material transfer agreements (MTAs), and other related information shall also be made available via the website of the Biorepository. (B) Specimen Inventory System, The University of Michigan is the sole proprietor of the specific version of the inventory management system developed for the SWAN Biorepository. Therefore, there is limited access to the data management system itself. The Contractor shall use an electronic inventory system to manage the biospecimen inventory which shall include the following features: 1) biospecimen management; 2) requisition/workflow tracking; 3) freezer/inventory management; 4) comprehensive reporting; 5) shipment and discrepancy tracking; and 6) security features. The inventory system shall be customizable to meet the changing needs of the SWAN Biorepository. The Contractor shall establish systems to ensure data security and to prevent loss of inventory data in case of physical damage or equipment failure. The Contractor shall establish systems that prevent access to biospecimens and data by unauthorized individuals. The BSI Website is available to specific approved users to access specific inventory reports, query the data, submit outgoing requisitions for testing or provide incoming shipment notification. Under no circumstances are any personal identifiers of the study participants entered into this system. The Contractor shall develop a plan for recovery of stored biospecimens and data following a natural or man-made disaster. (C) System Security, the Contractor shall provide an Information Technology (IT) Security Plan compliant with the Federal Information Security Management Act of 2002 (FISMA) to ensure security of all data existing or generated over the life of the contract. The Contractor must implement and maintain security requirements and backups for the computer system and other database and hard copy systems to provide security against anticipated risks including loss of specimen data, and access to records by unauthorized personnel or outside entities. (4) Secure, Receive, Catalog, Process, Store, and Disburse Repository Specimens to and from the SWAN Biorepository, The Contractor shall provide a technical and administrative infrastructure to ensure efficient planning, initiation, implementation and management of the repository's activities; Collect SWAN specimens; and Coordinate all incoming and outgoing shipments to preserve specimen integrity and utility. Approximately 114,000 specimens will be collected at the seven (7) clinical field sites participating in the current SWAN project period ending in 2014. The Contractor shall support specimen collection for the SWAN Biorepository and shall be responsible for providing collection kits. Each kit shall contain fully barcoded tubes, collection and shipping materials and a barcoded logging-instruction sheet to provide redundant options for electronic data entry by wanding at the clinical site. The Contractor shall secure and utilize shipment services by established carrier(s) with a proven record for handling medical/clinical specimens in shipping containers with dry ice, liquid nitrogen, or other refrigerants, as needed. A secure package tracking system must be utilized to ensure that all specimens are delivered to the intended recipient. The contractor shall arrange for the shipment of specimens to the SWAN Biorepository from the seven (7) clinical field sites via overnight express shipments. All shipping and handling charges of specimens shall be borne by the Contractor; The contractor shall perform a fully documented inspection and verification of all incoming shipments. Received shipments not containing any discrepancies shall be inventoried within five (5) business days. The Contractor shall commit specimens and data within 24 hours of verification of accurate and complete information or within 24 hours of corrective actions taken if discrepancies exist. Guidelines shall be established by the Contractor regarding acceptable data in the manifest, barcode, and readable label for specimen storage and identification. The contractor shall electronically track and record any discrepancies found with each received shipment and report all shipment discrepancies to the relevant Clinical Site within 3-5 business days of shipment receipt. The discrepancies shall be reported in the semi-annual reports. After permanent storage commitment, the Contractor shall perform, at a minimum, a 5% location quality control check on specimen location for each shipment. Routine customer satisfaction surveys shall be administered and the results documented in the semi-annual report. (5) Communications with the NIA Contracting Officers Technical Representative (COTR), Provide semi-annual progress reports regarding the Biorepository's progress on tasks as outlined in the Reporting Requirements. Updates, questions, emerging issues, and review of SWAN New Studies and Steering Committee decisions pertaining to proposed ancillary studies using repository samples will be discussed during bi-monthly conference calls that will include the COTR, SWAN Biorepository Principal Investigator, Project Manager and other Biorepository personnel invited by the Contractor and/or COTR; and Meet with the COTR at least twice per year to review progress reports, discuss anticipated or existing problems, review of SWAN New Studies Committee decisions, discuss SWAN Steering Committee and external Advisory Panel determinations and IRB decisions, and work to be performed. (6) Quality Assurance System, Develop a comprehensive Quality Assurance Program (QAP) to monitor the entire specimen management process, including specimen receipt and thorough inspection; specimen processing; specimen data management; inspection of shipping containers, and shipping of requested specimens; storage conditions at the box and freezer level and storage facilities including the central alarm system, air conditioning systems, and the back-up power system. Develop and conduct an internal audit process no less than semi-annually throughout the facility that produces reports summarizing the current status of repository operations and listing any non-conformances with Biorepository Standard Operating Procedures, Biorepository policies, and Federal, State, or local regulations; At least annually, the NIA will perform an external audit to review the repository facility and operations, and the QAP. (7) Specimen Integrity Evaluation, Provide a program for the periodic assessment of the biological integrity and viability of the various types of stored specimens in order to correlate storage period and storage conditions with specimen degradation and loss of activity; The specimen integrity evaluation results shall be included in the Semi-Annual Progress Reports. (8) Outreach Efforts, Attend up to two relevant national meetings, workshops, or conferences and organize information booths or orientation sessions for interested users of SWAN specimens; Advertise the availability of SWAN resources in relevant scientific journals; REPORTS/DELIVERABLES: All reports shall be submitted in electronic form as PC-formatted computer files in Microsoft Word and Microsoft Excel and/or searchable PDF format. All reports shall be archived on CD or other appropriate media for provision to the COTR at the expiration of the contract. The following reports will be required: A. Progress Reports, for the first two years of the contract, the Contractor shall submit quarterly progress reports and thereafter semi-annual progress reports. Two copies of the Progress Reports shall be submitted to the COTR and the CO on the 30th of the month following each quarterly (years 1 and 2) or semi-annual (years 3-5) reporting period; B. Final Progress Report and Summary of Salient Results, the Final Report shall cover the entire contract performance period and be in sufficient detail to explain comprehensively the accomplished tasks, a brief description of any unfinished job, and a status report on transition or shut down activities. In addition, the Contractor shall provide a 200 word minimum "Summary of Salient Results" detailing the important accomplishments from the contract during the performance of the contract. A draft of the Final Report shall be submitted for review by the NIA COTR 60 days prior to the completion of the contract. The Final Report shall be submitted prior to, or at the completion of the contract; and C. Other Reports and Deliverables. The Contractor will be required to provide a manual for complete SWAN Biorepository standard operating procedures (SOPs), an on-line user Manual for all SWAN components and outside researchers, to include the SWAN Biorepository policies, guidelines, and reference materials; an implementation plan for the comprehensive Quality Assurance Program for the SWAN Biorepository, including key indicators and a questionnaire for feedback on provided services; and upon contract completion the Contractor shall deliver to the COTR specimens, inventory and software systems, including software programs, labeled and inventoried paper files; Government-Furnished Property; and Source Code and Object Code unless otherwise specified. ANTICIPATED PERIOD OF PERFORMANCE. The anticipated period of performance is one 12-month base year from 6/30/2011 through 6/29/2012 with four option years thereafter. OTHER IMPORTANT CONSIDERATIONS: (1) The government is expected to use procedures in FAR Part 15, Contracting by Negotiations. The North American Industry Classification System (NAICS) Code will be 621991 ($10.0 Million). (2) The Contractor shall obtain services from SeraCare Life Sciences, 8425 Progress Drive, Frederick, MD. The frozen biospecimens from the seven (7) SWAN clinical field sites are currently housed at SeraCare in sixty-five (65) 80⁰C mechanical freezers purchased by the University of Michigan (using government funds from a grant supporting the SWAN Repository). There are 1.7 million highly perishable and irreplaceable biological specimens (whole blood, serum, plasma, urine, extracted DNA, buccal cells, immortalized cells) contained in these freezers. Relocation of this large repository collection from SeraCare's location entails 1) significant risks of damaging the viability of cells and loss of years of progress made for the SWAN study as well as 2) redundant freezer and unnecessary relocation costs. (3) The Contractor shall utilize the inventory management system developed for and used by the SWAN repository. Because the University of Michigan is the sole proprietor of this specific version, access to this data management system is limited. (3) The Contractor shall obtain required shipping licenses and permits from local, State, Federal and international authorities for the safe import, storage and distribution of biological specimens, according to current regulatory guidelines, as applicable. The Contractor shall provide proof of required licenses prior to contract award. CAPABILITY STATEMENT/INFORMATION SOUGHT. a. Capability Statement - Respondents to this notice must provide, as part of their responses, a capability statement to include the following: (1) information regarding respondents': (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information; (2) provide any catalog/list prices for services described in this notice; (3) respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc) pursuant to the applicable NAICS code(s); and (4) any other information that may be helpful in developing or finalizing the OPDIV's acquisition requirements. b. Information Submission Instructions - Respondents should provide responses accordingly: (1) submit information both electronically and by mail. No telephone and facsimile responses will be accepted; (2) format capability statements using Microsoft Word or Adobe PDF including attachments, resumes, charts, etc. Use single space, 12 font minimum and 8 ½ x 11 size paper; (3) organize material in such a manner that clearly identifies and address capability requirements and provide an executive summary; (4) capability statement should not exceed ten (10) single sided pages including references; (5) respondents must send two original copies via mail and one electronic copy via email; (6) RESPONSES SHOULD BE RECEIVED NO LATER THAN JULY 9, 2010 at 12:00 PM LOCAL TIME; (7) include respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses; and (8) send responses to this notice via email to wilsonr@mail.nih.gov. The original statements mailed using the U.S. Postal Service should be sent to ATTN: Rosanne S. Wilson, National Institutes of Health, Office of Acquisitions - NIDA Neuroscience COAC, NIA R&D Contracts Management Section, 6001 Executive Boulevard, Room 8154, MSC 9661, Bethesda, MD 20892-9661. If using a courier service such as the UPS, Federal Express, etc., change the City, State and Zip Code to Rockville, MD 20852. (Please be aware that the U.S. Postal Service's "Express Mail" DOES NOT deliver to the Rockville, Maryland address.) DISCLAIMER AND IMPORTANT NOTES. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
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