SPECIAL NOTICE
B -- Sole Source Acquisition to Set Up a Community-Based Effort to Acquire Clinical Specimens from Patients with STARI Diagnosis
- Notice Date
- 2/21/2008
- Notice Type
- Special Notice
- NAICS
- 611310
— Colleges, Universities, and Professional Schools
- Contracting Office
- Department of Health and Human Services, Center for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, GA, 30341-4146, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- 00HCVHCC-2008-52351
- Response Due
- 3/6/2008
- Archive Date
- 3/7/2008
- Point of Contact
- Linda Young, Purchasing Agent, Phone (770) 488-2655, Fax (770) 488-2777
- E-Mail Address
-
lml3@cdc.gov
- Description
- The Centers for Disease Control and Prevention indends to issue a sole source purchase order to the University of North Carolina, Department of Family Medicine, Chapel Hill, NC 27599, to procure services to set up a community-based effort to acquire clinical specimens from consenting patients who have a diagnosis of Southern Tick-Associated Rash Illness (STARI). Patients have been observed to develop a rash illness that resembles early Lyme disease after lone star (Amblyomma americanum) tick bites. The cause of this illness is unknown, although it is not due to borrelia burgdorferi, the bacteria that cause Lyme disease. This illness was first recognized in patients exposed to lone star ticks in southern states and these ticks are found predominately, but not exclusively, in the south. The condition is currently called STARI (southern tick-associated rash illness) to reflect these associations. Previous work by ourselves and others has evaluated the hypothesis that an organism of the genus borrelia is the etiologic agent, based on our detection of Borrelia lonestari in the skin of a rash patient and in the attached lone star tick. However, further investigations failed to link borrelia to STARI patients in most cases. To continue to search for the cause of this illness, CDC needs skin biopsy and blood samples from STARI patients and ticks that attached to the rash site (when available). For purposes of this procurement, a STARI patient is defined as: A person with acute onset (within 14 days of visit to a health care provider's office) of an annular, erythematous, expanding rash that attains a size of at least 5 cm in diameter, when no alternative explanation for the rash can be found, and a history of tick bite or potential exposure to ticks within 14 days before the onset of the rash. Systematic analysis of clinical samples and ticks may provide new insight regarding the the cause of STARI. The purpose of this procurement is to obtain clinical information and specimens from patients meeting the CDC case definition of STARI. The clinical samples will subsequently be evaluated by CDC investigators in order to develop a hypothesis about the cause of this illness. Portions of the samples will be analysed by Universal Biosensor, a technology offered by a private company. In addition, clinical materials will be evaluated by methods such as polymerase chain reaction, serology, passage of appropriate samples into mice, and testing of mouse tissues. CDC may benefit from this procurement by acquiring data that may point to the cause of STARI. Once a cause is known, laboratory tests may then be devised by CDC staff to evaluate specimens from patients who are suspected to have this illness. The scope of work for this procurement is as follows: Vendor must establish a mechanism and project team to enroll patients who meet a case definition of STARI in an area previously shown to be suitable for identifying such patients. This work will include developing documents to obtain informed consent from patients and assuring that the federal and institutional standards for protection of human subjects are met. Vendor must work with collaborating physicians to enroll properly informed, eligible, and consenting volunteers and obtain clinical samples as specified in a CDC Institutional Review Board-approved study protocol. Vendor must handle clinical materials so that their biologic integrity is preserved and transfer them, together with relevant clinical information, to investigators at the CDC. The vendor shall set up the means to acquire appropriate clinical specimens from volunteers in the community during the peak period of STARI occurrence (March through at least July, 2008). This effort must be made in conformance with all applicable regulations to project human subjects. The required outcome is an effort that can reasonably be expected to produce skin biopsy samples and blood specimens from 12 different patients, although 20 would be desirable. Components of the technical means to meet the required outcome include designating a study coordinator, contacting and training potential collaborating medical care providers, advertising the study in the relevant communities to encourage patient participation, reimbursing providers for phlebotomy and skin biopsy charges in accordance with the CDC compensation scale (when necessary), and facilitating acquisition of clinical samples. The vendor shall transfer or facilitate the transfer of the deliverables to CDC, Fort Collins, Colorado. The government will furnish the study protocol and documents specified above, as well as study kits and prepaid airbills. The vendor shall provide the following deliverables to the project officer by the times specified: (1) A copy of the informed consent documents approved by vendor's Institutional Review Board within 2 months of purchase order award; (2) Proof of hiring a study coordinator within 2 months of purchase order award; (3) Names of all, but minimum four, collaborating medical clinics in a STARI-endemic area, within 2 months of purchase order award; and (4) skin biopsy specimens, blood, and serum samples, as specified in the CDC study protocol, from at least 12 patients no later than September 30, 2008. This procurement involves setting up a community-based effort to acquire clinical specimens; minimum vendor qualifications consist of: (1) Previous experience in the design and implementation of a community-based medical study, preferably evidenced by peer-reviewed publications; (2) Knowledge of human subjects protection requirements, preferably evidenced by IRB-approval of a previous protocol or informed consent document. Institution must have a FWA number; (3) Ability to demonstrate access to patients who meet the CDC case definition of Southern Tick-Associated Rash Illness (STARI); (4). A medical degree should be held by the principal investigator (M.D., D.O., or equivalent), and (5) Ability to start project immediately for the 2008 peak STARI transmission season (approximately March through July). Vendor must be able to facilitate sample acquisition and same-day transfer to CDC by overnight courier service. Vendor must have office support to pay charges for phlebotomy and skin biopsy specimen acquisition when requested by collaborating clinics. The state epidemiologist of North Carolina identified the above mentioned vendor as having access to the appropriate STARI study population, besides fulfilling all other requirements for this procurement.CDC believes that this requirement is met by only one provider. This procurement will be processed under the authority of FAR 6.302-1 and 6.302-2. Only one responsible source and no other sources will satisfy agency requirements. No solicitation is being issued. Interested persons may identify their interest and capability to respond to this requirement. This procurement is not set-aside for small business. For contractual questions contact Linda M. Young.
- Place of Performance
- Address: CDC Fort Collins, Rampart Road, Fort Collins, CO
- Zip Code: 80521
- Country: UNITED STATES
- Zip Code: 80521
- Record
- SN01513545-W 20080223/080221223532 (fbodaily.com)
- Source
-
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