SOLICITATION NOTICE
B -- Services regarding the evaluation of cervical cytology, biopsy and endocervical curettage specimens and HPV genotyping relating to the Biopsy Study within the Study to Understand Cervical Cancer Early Endpoints and Determinants (SUCCEED)
- Notice Date
- 8/19/2009
- Notice Type
- Presolicitation
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-90204-AV
- Archive Date
- 9/12/2009
- Point of Contact
- Ashley L. Virts,
- E-Mail Address
-
virtsa@mail.nih.gov
(virtsa@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Hormonal and Reproductive Epidemiology Branch (HREB) plans to procure on a sole source basis with The University of Oklahoma; Department of Pathology; PO Box 26901; Oklahoma City, OK 73104-5410 services regarding the evaluation of cervical cytology, biopsy and endocervical curettage specimens and HPV genotyping relating to the Biopsy Study within the Study to Understand Cervical Cancer Early Endpoints and Determinants (SUCCEED). The services herein are being procured in accordance with the simplified acquisition procedures authorized by FAR Part 13.106-(b)(1). The North American Industry Classification System Code is 621511 and the business size standard is $13.5 M. The main objective of the Biopsy Study within the Study to Understand Cervical Cancer Early Endpoints and Determinants (SUCCEED) is to study the etiology of cervical disease on the lesion level and to quantify the benefit of multiple biopsies for disease ascertainment. The laboratory will document the colposcopic impression, location of lesions, and biopsy sites using a digital colposcopy system. This system allows linking the cervical appearance, visual impression, biopsy severity and order to the clinical, histological, and molecular outcomes. It is therefore important to obtain individually reviewed biopsy results. In clinical practice, it is common to embed multiple biopsies into one tissue block to save time and resources. However, combining different biopsies into one block does not allow linking the individual biopsy results with the topographic visual information. Therefore, to achieve the goals of the study, independent analysis of each individual biopsy is needed. To improve disease ascertainment, the study also includes a more extensive protocol to obtain endocervical curettages (ECCs) in women 30 years or older to detect endocervical disease. In addition, the data findings from the contractor will be used in the future by the NCI to relate cytological findings and viral genotyping data to the biopsy, ECC, LEEP/Top Hat results, as well as HPV genotyping for all cytology specimens. The contract will evaluate cytology, biopsy, and LEEP specimens from 1000 participants. In addition, HPV genotyping shall be performed from all cytology specimens as specified below: Base Year: 700 Thinprep slides; 910 Biopsy slides with 28 ECC specimens affixed (as needed in women 30 years or older); 18 Leep/Top-Hat samples; 700 HPV specimens Option Period: 300 Thinprep slides; 390 Biopsy slides with 12 ECC specimens affixed (as needed in women 30 years or older); 7 Leep/Top-Hat samples; 300 HPV specimens The period of performance for this procurement shall 12 months from the date of award (base period) with one six (6) month option period. The services required for the study are in part regular diagnostic procedures performed to manage women with abnormal cervical cancer screening results at the University of Oklahoma. More specifically, pathologist collaborators at the University of Oklahoma have unique access to women treated at their institution and it is not feasible to distribute biopsy, cytology, and LEEP/Top Hat procedures from a subset of patients to a different pathology department. There is considerable heterogeneity in the quality of these diagnostic procedures. Reproducibility between groups is not possible as well as quality associated with experience of the laboratory which houses Dr. Rosemary Zuna, who is responsible for current pathology services in SUCCEED which is the predecessor study to the objectives within this current procurement. For the current phase of SUCCEED, it is critical to keep a high and constant standard of pathological procedures and evaluation methods. In addition, data from women enrolled into the new phase cannot be compared to SUCCEED patients at any other laboratory. To ensure continuity and comparability of the results within SUCCEED it is important to continue HPV genotyping at the same site. Data within the pathology laboratory at the University of Oklahoma is proprietary to both the SUCCEED study and the methods used to evaluate diagnostic study samples. For these reasons, it is not feasible to perform pathology procedures as outlined in this procurement with any other source. This is not a request for competitive quotation. However, if any interested party believes it can meet the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the researcher to determine if the party can meet this requirement. One (1) original and one (1) copy of the capability statement must be received in the contracting office by 11:00 a.m. ET on August 28, 2009. All questions must be in writing and can be faxed to 301-402-4513 or sent via email to Ashley Virts: virtsa@mail.nih.gov. It is the vendor's responsibility to ensure questions have been received. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, contractor must have valid, updated registration and certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Application (ORCA). Please reference NCI-90204-AV on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/NCI-90204-AV/listing.html)
- Record
- SN01917860-W 20090821/090820000556-f2a6e9a428a8893a854b6ad7ca659fe9 (fbodaily.com)
- Source
-
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