JOFOC_Collection_of_Discarded_Cervical_Cancer_Screening_Specimens.pdf

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"Source Selection Information - see FAR 2.101 and 3.104"

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity.

Department of Health and Human Services (DHHS)/ National Institutes of Health (NIH)

b. Sponsoring organization.

DHHS/NIH/NCI/Division of Cancer Epidemiology and Genetics (DCEG)/Clinical Genetics Branch

c. Project Officer Information.

• Project Officer Name.

• Mailing address.

• E-mail address.

• Telephone number.

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives

The NCI will obtain and store “discard” HPV and cytology specimens as well as collect risk factor and clinical outcome data for a population-based sample of women in the cohort. These specimens are termed “discard” because they are routinely collected for cancer screening and discarded soon after processing in the laboratory that runs the cervical cancer screening tests.

Instead of discarding the specimens, the NCI seeks to collect them before they are destroyed.

After transferring the specimen into storage tubes, they shall be shipped to the NCI Biorepository and stored for later testing by NCI.

b. Project Background

Despite HPV vaccines, screening will remain central for decades to control cervical cancer.

Recently, HPV testing alone or with cytology was introduced in the US as an alternative to cytology screening. However, most HPV infections are harmless and additional tests are required to identify women at highest cancer risk. With three (3) options for primary screening, and without clear strategies for triage of screen-positive women, there is great confusion about the best approach. Also, increasing HPV vaccination coverage will lead to lower disease prevalence, and force new screening approaches. Therefore, NCI plans to evaluate performance of several promising biomarkers head-to-head in a screening population. Integral to these studies are cervical specimens and clinical data among women screened.

Justification for Other than Full and Open Competition

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The proposed acquisition is an add-on to a previous study collecting discard specimens at Kaiser

Permanente Northern California (KPNC) funded through three Westat subcontracts. Through the three Westat subcontracts, KPNC has collected HPV and cytology specimens for 55,000 women screening HPV-positive and shipped them to the NCI biorepository. KPNC is in the process of collecting specimens from 23,000 women under the fourth subcontract. Through these subcontracts, KPNC has provided de-identified datasets containing participants’ risk factors and clinical data. The contract numbers of the previous acquisitions are as follows:

Contract # Period of Performance

Subcontract under Westat Contract HHSN261200800029C December 16, 2008 – February 28, 2011

Subcontract under Westat Contract HHSN261200655504C April 29, 2011 – October 31, 2012

Subcontract under Westat Contract HHSN261201300003C November 21, 2012 – June 20, 2013

Subcontract under Westat Contract HHSN261201300016C September 1, 2015 – August 30, 2016

3. Description of the supplies or services required to meet the agency's needs (including the estimated value).

a. Project title.

Collection of Discarded Cervical Cancer Screening Specimens

b. Project description.

1. As specified by the NCI protocol, the Contractor will develop SOPs for sample processing and data extraction.

2. As specified by the NCI protocol, the Contractor will sequentially identify within their routine laboratory practices samples from 20,000 women age 25 and older undergoing cervical cancer screening. For this collection, the Contractor will pull the specimens from short-term storage prior to the planned discard of HPV and cytology specimens for these women.

3. As specified by the NCI protocol, the Contractor will create and update quarterly a SAS (statistical analysis software) database of specimens that protects against release of identifying information and includes study ID and linkage of specimens to women and their clinical characteristics/cervical outcomes, prior to and after enrollment. Data that shall be included in the dataset include: date of birth, STD information (chlamydia, HIV, gonorrhea), hormonal contraception use, smoking status, BMI, and entire history of HPV, Pap results, and all coded cervix histology results (from biopsy, excisional procedures or hysterectomy), previous and future enrollment status. Cervix histology results not previously coded will be coded for the purposes of this study.

4. As specified by the NCI protocol, the Contractor will provide a monthly report of study activities.

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5. As specified by the NCI protocol, the Contractor will transfer HPV and cytology specimens to storage tubes. The Contractor will process HPV specimens under conditions specified by the NCI that ensure no cross-contamination of specimens and store them frozen in a new transport tube before shipping. Cytology specimens will be processed and aliquoted as needed into new transport tubes and stored either frozen or at ambient temperature.

Specimens will be appropriately labeled using a randomized non-identifiable study ID.

6. Within one (1) month of collection the Contractor will send all specimen aliquots to either the NCI Fisher Biorepository or another recipient designated by the NCI Contracting Officer’s Representative (COR). The Contractor will ship specimens at appropriate temperatures (ambient or frozen) as specified by the NCI protocol.

7. As specified by the NCI protocol, the Contractor will send all women selected for the collection an opt-out letter and track responses.

• Requirement type.

Research & development (R&D) R&D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ________

• Type of action.

New requirement Follow-on Other (specify): _________

• Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed price incentive-fee): ___ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): Cost-reimbursement No Fee Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): _____ Other (specify): ___ Completion Form Term form

•Acquisition identification number. RFP N02CP61008-72

b. Total estimated dollar value and performance period if JOFOC is approved:

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4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1(a)(2)(ii).

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of

1996.

This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed Contractor unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed Contractor.

Division of Research Kaiser Permanente Northern California 2000 Broadway - 3rd Floor - 032R06 Oakland CA 94612

b. Nature of the acquisition and proposed unique qualifications of the Contractor.

The proposed Contractor, Kaiser Permanente Northern California (KPNC), is uniquely qualified as follows:

KPNC is already collaborating with the NCI on a previous study that had similar design and has collected discard specimens from 55,000 women and is in the process of collecting from 23,000 women. Conducting the proposed effort in KPNC allows continued follow-up of women enrolled in the previous study with KPNC and the utilization of existing infrastructure including the established IRB and data sharing agreements with KPNC. KPNC is the only entity that has IRB approval to follow the participants and cohort. Beyond that, the NCI has another established collaboration with KPNC to collect data on all 1.5 million women screened for cervical cancer at KPNC clinics. The proposed acquisition will generate a representative sample of women from the overall screening population with biospecimens. This will allow the NCI to weight results from the biospecimen cohort back to the entire screening population.

This contract requires a vendor who can quickly and efficiently collect HPV and cytology specimens for 47,000 women undergoing routine cervical cancer screening and provide detailed clinical and risk factor history and follow-up. Importantly, KPNC screens over 1.5 million women and initiated HPV and cytology cotesting in 2003. Since only 5-10% of women are HPV-positive and screening intervals are 3 years, a population of this size is needed to enroll a large number of HPV-positive women. Therefore, KPNC is uniquely qualified to continue this project that will

Base Period Option Period 1 Option Period 2 Option Period 3 Total

Months (12) Months (12) Months (12) Months (12) Months (48)

JOFOC 5 of 6 systematically sample the screening population. There is no other provider routinely offering HPV-cytology co-testing to over 1 million women for over 10 years and allowing medical record linkage in a population large enough to provide the required participants.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

Market Research was conducted through the release of a sources sought notice published in FedBizOpps on February 26, 2016 and amended on March 1, 2016. One response was received from a small business in response to the sources sought notice on March 7, 2016. However, it was determined that the response did not demonstrate sufficient experience and capability to perform the required services, because the business did not demonstrate having a routine laboratory practice that can sample specimens planned for discard from 20,000 women age 25 and older undergoing cervical cancer screening and 27,000 women age 25 and older testing HPV-positive. Additionally, the business does not demonstrate access to clinical datasets within an integrated health services delivery system.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

A cost analysis of the proposal will be conducted by the Contracting Officer using FAR Subpart

15.404 and the principles established in OMB Circular A-122 “Cost Principles for Non-Profit Organizations”

The COR and Contracting Officer will evaluate all proposed costs, then complete and sign the COR Technical Questionnaire form;

Certified cost and pricing data will be obtained from the offeror since this is a non-competitive acquisition.

An evaluation of the separate cost elements of the proposal will be compared against the Independent Government Cost Estimate

8. Description of the market research conducted (see FAR Part 10) and the results or a statement of the reasons market research was not conducted.

The NCI researchers have long-term experience conducting population-based studies of cervical cancer screening and HPV. NCI researchers conducted extensive market research to identify large health care provider organizations that routinely screen with HPV and cytology testing, uses a centralized laboratory that could provide residual specimens, and systematically collects clinical and risk factor data. There is no other provider routinely offering HPV-cytology co-testing to 1.5 million women for over 10 years and allowing medical record linkage in a population large enough to provide the required participants. There is no other provider that can link to the KPNC population that is already being studied by NCI.

9. Any other facts supporting the use of other than full and open competition.

All facts and rationale to justify the use of the cited authority have been provided above.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No expressions of interest have been received to date.

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11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

No additional contracts for this project are anticipated that would involve other than full and open competition. However, In the event NCI requires additional services not covered under this procurement the proposed requirement will be synopsized in the FedBizOpps. An award will only be made, if during negotiations, it is shown that the anticipated cost to the Government is fair and reasonable.