SOLICITATION NOTICE
B -- Puncture Skin Test Study
- Notice Date
- 5/2/2008
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Acquisition and Assistance Field Branch (Cincinnati), 4676 Columbia Parkway, M/S C-4, Cincinnati, Ohio, 45226
- ZIP Code
- 45226
- Solicitation Number
- 2008-Q-10463
- Response Due
- 6/11/2008 4:30:00 PM
- Point of Contact
- Jennifer M Bayer,, Phone: (513)533-8586, Dwight D Favors,, Phone: (513)533-8137
- E-Mail Address
-
jmh8@cdc.gov, dyf3@cdc.gov
- Small Business Set-Aside
- N/A
- Description
- PRE SOLICITATION NOTICE: The Centers for Disease Control & Prevention/National Institute for Occupational Safety and Health (NIOSH), located in Cincinnati, Ohio, has a requirement for a study to perform puncture skin tests. The CDC intends to award a single Firm-Fixed-Price Purchase Order in accordance with FAR Part 13. The period of performance shall be September 29, 2008 through September 29, 2009. The description is as follows: TITLE: Puncture Skin Testing with orthophthaldehyde and Glutaraldehyde I. BACKGROUND Orthophthaldehyde (OPA) is marketed, sold, and used as a "safe" replacement for glutaraldehyde (GTA) for sterilization of heat sensitive dental and medical devices. The disinfecting mechanism of OPA is considered to be similar to glutaraldehyde which kills organisms by the binding of the aldehyde to the cellular wall. Glutaraldehyde use for disinfection has been associated with a number of health problems including dermatitis and occupational asthma. There is limited information about the health effects for workers who use OPA. II. PURPOSE To perform puncture skin tests study of approximately 140 individuals who are exposed to orthophthaldehyde. If puncture skin testing is to be performed at sites greater than 50 miles from the Cincinnati, Ohio area, the Government will supply all travel, lodging and per-diem for the Contactor and his agents. Distant sites may include areas as distant as the US coasts. It is anticipated that approximately 70 individuals will be tested within 50 miles of Cincinnati, Ohio. NOTE: This potential needed travel is not to be included in cost proposal. CDC/NIOSH shall pay for individuals travel directly in accordance with Federal Travel Regulations Guide. III. SCOPE OF WORK The vendor will provide all labor, materials, and equipment required to complete the tasks outlined below. Contractor will be responsible for compensating subjects at a nominal rate (not to exceed $75.00 per skin test subject). The CDC/NIOSH shall recruit the individual subjects for this skin testes study. IV. TASKS TO BE PERFORMED 1. Percutaneous Testing. A. Puncture skin test 140 individuals with 24 mg/ml and 2.4 mg/ml glutaraldehyde (GTA) and 5.5 mg/ml and 0.55 mg/ml orthophthaldehyde (OPA) using the methods of Sokol WN, (Nine episodes of anaphylaxis following cystoscopy caused by Cidex OPA (ortho-phthalaldehyde) high-level disinfectant in 4 patients after cytoscopy, J Allergy Clin Immunol. 2004 Aug;114(2):392-7) using GTA and OPA supplied by the US Government. B. Puncture skin test individuals with common aeroallergens including histamine and saline controls. The contractor shall supply all professional services, supplies and appropriate diluents and controls. The contractor shall prepare these solutions for puncture skin testing in the spirit of Good Laboratory Practices and with the normal attention to safety and patient comfort attended to by a board certified allergist in the conduct of skin testing in private practice. 2. Notification letters A. Prepare individual notification letters, interpreting in layman terms, the individual significance of data from task A of this contract to all individuals tested in the conduct of this contract. The content and style of these letters shall be approved by the Project Officer prior to their mailing and shall be signed by a Board Certified Allergist. V. GOVERNMENT FURNISHED MATERIALS The government will supply the contractor with glutaraldehyde and orthophthaldehyde. VI. PERIOD OF PERFORMANCE The period of performance shall commence upon award of a purchase order and shall continue through the next 12 months and completed no later than September 29, 2009. No work will commence until Institutional Review Board approval is obtained by the government. VII. DELIVERABLES All electronic files should be delivered in MS Word or Excel format and provided via e-mail. Deliverables & Date Required: •Government will identify 30 individuals for puncture skin testing (PST) and PSTs completed. Date Required: September 29, 2008 •Government will identify 60 individuals for puncture skin testing (PST) and PSTs completed. Date Required: June 2, 2009 •Government will identify 50 individuals for puncture skin testing (PST) and PSTs completed. Date Required: September 29, 2009 VIII. MINIMUM CONTRACTOR QUALIFICATIONS: a. The Contractor shall be an M.D. and have been an author of at least 3 peer-reviewed journal publications where puncture skin testing with occupational agents was reported. b. The contractor shall be a Diplomate of the American Academy of Asthma, Allergy and Immunology (Board certified allergist) as well as be Certified in Diagnostic and Laboratory Immunology. c. Institutional Review Board approval (US Government) will be received prior to commencement of work performed under this requirement. The complete solicitation/Request for Quotation document, will be available for downloading @ www.fedbizopps.gov on or about May 16, 2008. No verbal or written requests for copies will be accepted. Please, no phone calls. It is the responsibility of perspective offerors to stay abreast of additional postings regarding this solicitation at the FedBizOpps internet site. No government-wide notes apply. All vendors must be registered in the Central Contractor Registry (CCR) prior to an award of a federal contract. The website is: www.ccr.gov. All responsible responsive sources may submit an offer which shall be considered by the agency.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=f5293a7b36859ccb46aae14ff47d5be0&tab=core&_cview=1)
- Place of Performance
- Address: See statement of work, United States
- Record
- SN01565811-W 20080504/080502220059-f5293a7b36859ccb46aae14ff47d5be0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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