J A_seq01737172_Aperio_Scanner.docx

Attachment C Justification and Approval for Sole Source (J&A)

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS/NIH/NIAID.

b. Sponsoring organization. OD

c. Point of Contact Information.

· Point of Contact. Dan Long

· Mailing address. 903 S 4th St Hamilton, MT 59840

· E-mail address. Raymond.long@nih.gov

· Telephone number. 406-363-9247

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

a. Acquisition purpose and objectives. The Rocky Mountain Laboratories Histology Department has an existing Aperio ScanScope XT which is a proprietary instrument utilized for morphometric analysis (positive pixel count & color deconvolution) when evaluating pathology tissues during the course of infectious disease research. This system is used extensively for pathological investigations of Ebola virus, Lassa virus, Marburg virus, Corona virus and Hanta virus for the Laboratory of Virology. The scanning system is also used for infectious disease investigations of Prion agents, Staph aureus, Salmonella, and many other infectious pathogens being studied at Rocky Mountain Laboratories.

b. Project background The current whole slide scanning system (Aperio ScanScope XT) is composed of two separate scanners (Brightfield & Fluorescent), based on the Aperio software platform. The current Brightfield scanner is in need of immediate replacement. Current scanning of Ebola research project and other infectious disease projects has been completely curtailed due to the Scanscope XT equipment failure.

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

a. Project title. Aperio AT2 Scanning System

b. Project description. The purpose of this requirement is to replace the currently failing Aperio scanning system with upgraded technology while maintaining continuity with existing libraries of information generated by the existing system.

· 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): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, Definite quantity or requirements): ___________ Other (specify): ___________ Completion Form Term form

· Acquisition identification number. AMBIS sequence # 1737172

c. Total estimated dollar value and performance/delivery period. The estimated dollar value of this contract is $232,648.00.

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)(c). Brand Name

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(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

This is a Brand Name acquisition. Three potential vendors were discovered.

Leica Microsystems Inc 1700 Leider Ln Bufalo Grove, IL 60089

Government Scientific Source 12351 Sunrise Valley Drive Reston, Va 20191

Bartels and Stout Inc 22525 SE 64th Pl Ste 160 Issaquah, WA 98027

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

The existing Aperio ScanScope XT is a proprietary instrument utilized for morphometric analysis (positive pixel count & color deconvolution) when evaluating pathology tissues during the course of infectious disease research. The ScanScope XT system is a proprietary product of Leica Microsystems which is sold through their authorized distributors. Replacement of this scanner with the Aperio AT2 will ensure continuity of investigation by utilizing our RML custom designed IT interface with the Aperio software. Only authorized distributors may sell this product and provide warranty service after the sale.

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.

A market survey was conducted through internet research, surveying previous orders and interviewing program personnel. This acquisition was determined to be a Brand Name acquisition based on the technical requirements to obtain a system which would maintain compatibility of new data with existing data, and would be compatible with the custom built library interface which was built by the NIH NIAID IT department for that purpose. Currently approximately 20,000 whole slide scanned images are housed in the database and can only be accessed by using the Aperio ScanScope XT. These scanned images can be recalled and reviewed whenever an investigator has the need and interactively shared with investigators worldwide. The Aperio AT2 would offer the same access to this database.

A FedBizOpps notice will be posted for this Brand Name acquisition. All known authorized Leica dealers will be notified of the solicitation. FAR 5.202-10

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

An independent Government Cost Estimate has been developed (IGCE) based on the history of the previous contract, budget estimates from two of the potential vendors and program expectations. However, to ensure that the price will be fair and reasonable, the data from the IGCE will be compared with the proposal received from all responding offerors. An award will be made only if during negotiations it is shown that the anticipated cost to the government will be fair and reasonable.

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.

Market Research was conducted to seek out potential sources.

The results of market research have determined that the Government's needs can be met by items of a type customarily available in the commercial marketplace.

C. Results.

Results of Market Research were as follows:

Based on the market research information, the Contracting Officer (CO) recommends the Aperio Scanner XT system be purchased open market. The CO has determined there is a reasonable expectation that offers would be obtained from at least two small business concerns that are competitive in terms of market price, quality and delivery but the products they offer are from a large business manufacturer and thus the Non-Manufacturer Rule applies based on FAR 19.102. Based on this information, and the absence of a waiver of the non-manufacturer rule for these items, it is recommended that the set aside for small business be withdrawn.

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

The current Brightfield scanner is in need of immediate replacement. Current scanning of the Ebola research project and other infectious disease projects has been completely curtailed due the Scanscope XT equipment failure. The ScanScope XT system is a proprietary product of Leica Microsystems. Replacement of this scanner with the Aperio AT2 will ensure continuity of investigation by utilizing our RML custom designed IT interface with the Aperio software.

Conversely, procurement of a competitive scanning system would require building a new interface with our database, and ultimately require maintaining two separate scanning data systems. These two differing systems would not interoperate and comparative review of currently stored data with newly collected data would not be possible. Teaching two separate software and algorithm systems to investigators would place an unnecessary workload on the Histopathology personnel. In addition, two separate service contracts would be required to maintain the existing Fluorescent scanner and a new competitive Brightfield scanner. Taken together all these disadvantages would increase annual budgetary costs and workload demands on Histopathology personnel.

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

Government Scientific Source and Leica Microsystems

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.

This acquisition is for equipment which will require ongoing supplies and maintenance service. Supplies for the existing equipment are able to be sourced from several vendors, so it is expected the supplies for this equipment will be similarly available. Sources for certified maintenance on this equipment will be sought out and should include at least the current authorized dealers of Leica products.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Point of Contact

Project Officer’s Immediate Supervisor

Head of the Sponsoring Program Office

13. Contracting Officer Certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Contracting Officer

15. Competition Advocate signature. The designated OPDIV Competition Advocate (CA), upon acceptance of the rationale provided in the J&A, shall complete the information required below and sign in the block provided as the approving official for any J&A over $550,000 but not exceeding $57 million[footnoteRef:1]. However, if the CA does not meet the requirements of FAR 6.304(a)(3)(ii) for a J&A over $11.5 million, but not exceeding $57 million, an individual other than the CA shall exercise the approval authority. [1: This approval authority is applicable to the following dollar ranges cited in the FAR, specifically: (i) over $550,000, but not exceeding $11.5 million; and (ii) over $11.5 million, but not exceeding $57 million – see FAR 6.304(a)(2) and (3) and 13.501(a)(2)(ii) and (iii). See HHSAR 306.304(a)(2) and (3) and 313.501(a)(ii) and (iii) for additional information regarding this approval authority, including when the CA does not meet the requirements of FAR 6.304(a)(3)(ii). These dollar ranges are current as of the date of issuance of interim acquisition policy memorandum No. 2008-03, but are subject to change.]

The signature of the CA, or that of an individual meeting FAR 6.304(a)(3)(ii) requirements for a J&A over $11.5 million, but not exceeding $57 million, shall serve as concurrence on any J&A over $57 million that requires the approval of the HHS SPE.

Competition Advocate

16. HHS Senior Procurement Executive signature. The HHS SPE, upon acceptance of the rationale provided in the J&A, shall complete the information required below and sign in the block provided as the approving official for any J&A over $57 million[footnoteRef:2]. [2: This dollar range is current as of the date of issuance of interim acquisition policy memorandum No. 2008-03, but is subject to change – see FAR 6.304(a)(4) and 13.501(a)(2)(iv). See HHSAR 306.304(a)(4) and 313.501(a)(2)(iv) for additional information regarding SPE approval of a J&A in this dollar range.

HHS Senior Procurement Executive