J A-CPT_Gen-Probe_Redacted.pdf

LOG# 10221-14

Form 02.4G.AB/TDP 14-081-14 / PR N0025915RCE0013/Page 1 of 5 1 Nov 12

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Logistics Command (NMLC), Fort Detrick, MD, on behalf of the Naval Medical Center San Diego.

2. Nature and/or description of the action.

The proposed action is for a cost per test contract for analyzers, laboratory, molecular assay, infectious microorganism. The Government intends on awarding a Firm Fixed Price cost-per-test contract. The proposed source is Gen-Probe (Hologic) 10210 Genetic Center Dr, San Diego, CA, 92121.

3. Description of Supplies or Services:

The Naval Medical Center San Diego has a requirement for an IDIQ for a cost per test contract for automated, molecular assay, infectious microorganism laboratory analyzer system for NMC San Diego.

The equipment shall be automated systems capable of analyzing nucleic acids from urine and swab samples to test for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), Trichomonas vaginalis

(TV), and Human Papillomavirus (HPV). The systems shall be fully automated, random access robotic systems. The system shall be able to analyze endocervical and vaginal samples, urine samples for both males and females, and male urethral swabs. The system shall be able to test for CT, GC, TV and HPV on the same sample. For CT/GC specimens, the system shall be FDA-approved for testing the following sample types of both symptomatic and asymptomatic males and females: endocervical and vaginal samples, urine samples for both males and females, male urethral swabs and female PreservCyt liquid cytology specimens. The system shall be able to analyze other specimen types, such as rectal swabs, pharyngeal swabs and conjunctival swabs. For HPV specimens, the system shall be FDA-approved for testing female PreservCyt liquid cytology specimens directly or aliquoted into testing containers. If the original cytology specimen must be aliquoted prior to testing, a second instrument that performs automated sample processing (i.e. decapping primary and aliquot tubes, aliquoting and recapping primary and aliquot tubes) shall be included. The HPV assays shall be able to genotype HPV 16 and HPV 18. For

TV specimens, the system shall be FDA-approved for testing the following sample types of both symptomatic and asymptomatic females: endocervical and vaginal samples, female urine samples and female PreservCyt liquid cytology specimens.

The systems shall utilize nucleic acid amplification testing (NAAT) technology, performing simultaneous amplification and detection of target DNA or rRNA for CT/GC and TV and E6/E7 mRNA for HPV. The system shall be a fully automated system (all analytical steps performed onboard instrument). The automation platform shall be a single platform able to sample directly from patient collection tubes without removing caps and automatically dispense all reagents, perform all automated steps for NAAT.

The system shall be capable of performing the following procedures: sample preparation, separation suspension, reagent preparation, hybridization, separation, and detection. The system shall be able to analyze and verify results that will be transmitted to the instrument computer which then utilizes an interface to transmit the results to the DOD Composite Health Care System (CHCS) Laboratory

Information System. Specimen flow from start to finish shall be fully automated to include waste collection. The system shall be able to read Code 39 barcodes. The system must have specimen storage stability of at least seven (7) days in a transport container for urine and swap samples stored at 2-30 degrees Celsius. Specimens shall be able to be kept at -20 degrees Celsius for up to 90 days if the time of transport/storage exceeds 30 days. The system shall utilize closed primary testing containers with piercable caps to prevent specimen contamination. The system shall be capable of providing the following throughput per an 8.5 hour shift for the listed tests:

Form 02.4G.AB/TDP 14-081-14 / PR N0025915RCE0013/Page 2 of 5 1 Nov 12

Minimum Daily Throughput (per 8.5 hour shift)

Test Qty

CT 250

GC 250

HPV 80

TV 10

HPV 16/18 genotyping 10

The system shall be capable of expanding the test menu (run additional tests such as those being developed by the company or pending FDA clearance. The contract shall have a period of performance of five (5) years.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized maintenance contractor for the proposed equipment/system such that OEM warranty and service are provided and maintained by the

OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

The equipment shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the

FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The equipment shall be installed in compliance with OSHA requirements.

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

The statutory exception permitting other than full and open competition for this acquisition is 10 USC

2304(c)(1) and FAR 13.501(a), Sole Source Acquisitions. This acquisition is being conducted under simplified acquisition procedures FAR 13.501 under the authority of the test program for commercial items (section 4202 of the Clinger-Cohen Act of 1996).

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

Gen-Probe, who is owned by Hologic, is the only source capable of fulfilling the minimum requirements of the Government. Gen-Probe is the only vendor capable of providing a cost per test solution for an automated system and associated assays that is FDA-cleared for all of the required CT, GC, HPV and TV testing. The GenProbe Panther/Tigris with Aptima Combo 2 (AC2) assay is the only system/assay capable of providing all required CT, GC, HPV, and TV testing for NMC San Diego. The system/assay combination is the only fully automated system capable of performing all required tests from a single specimen. Procurement via a vendor other than Gen-Probe would require additional purchases of supplemental FDA approved systems, assays, and supplies. Also, procurement of an alternative system would require multiple specimens to be obtained from the patients from multiple collection devices. NMC

San Diego performs the required testing for its local patients, as well as those from NH Camp Pendleton, NH 29 Palms, NH Lemoore, NH Bremerton, NH Guam, NH Okinawa, NH Yokosuka and several ships

Form 02.4G.AB/TDP 14-081-14 / PR N0025915RCE0013/Page 3 of 5 1 Nov 12 with homeport in San Diego. The use of multiple systems and multiple collection devices would at least double the workload required to collect, transport, and load the specimens. The high workload performed at NMC San Diego requires the use of a single platform capable of all necessary tests.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to FedBizOpps in accordance with FAR 5.202.

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

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made. In addition, the Government anticipates that the negotiated contract price will reflect a discount from the vendor’s commercial price list and will be determined fair and reasonable.

8. Description of the market survey conducted and the results, or a statement of the reasons a market survey was not conducted.

Market research was conducted by technical experts in the March 2014 timeframe. This research consisted of reviews of previous procurements for these types of laboratory systems and a market survey through search engines of open market contractors and Federal Supply Schedule contractors. Search engines utilized include Google, Yahoo, MSN, and GSA Advantage. Finally, a search was conducted through the ECRI sourcebook catalog. Other vendors capable of performing automated CT/GC testing include Becton-Dickinson (BD), who manufactures the ViperXRT system, with ProbeTecQx assay;

Abbott, who manufactures the m2000sp/m2000rt, with RealTime CT/GC assay; Roche with their 4800

CT/GC; and Cepheid with their GenXpert platform. Of these, only the systems from BD and Roche (as well as Gen-Probe) are FDA-cleared to detect CT and GC on cytology specimens. Additionally, BD and

Abbott are unable to detect CT/GC on chromosomal sequences. Therefore, only Gen-Probe and Roche would be capable of fulfilling the minimum requirements for CT/GC testing. For automated HPV testing, only Gen-Probe and Roche are FDA-cleared to perform HPV genotyping analysis for the required HPV

16 and HPV 18. Abbott has an HPV assay, but it is not yet FDA cleared for the required testing. For TV testing, only BD and Hologic are capable of providing a system capable of running TV assays. In conclusion, Hologic is the only vendor capable of providing a solution capable of performing all required tests. Procurement of an alternate system would require an additional procurement of another separate system from a second vendor in order to provide a comprehensive test protocol.

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

None

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. This requirement will be posted on

FedBizOpps in accordance with FAR 5.202.

Form 02.4G.AB/TDP 14-081-14 / PR N0025915RCE0013/Page 4 of 5 1 Nov 12

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

Future requirements will be synopsized in accordance with FAR 5.203.

12. Point of Contact.

Form 02.4G.AB/TDP 14-081-14 / PR N0025915RCE0013/Page 5 of 5 1 Nov 12

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY FAR 13.501(a)(2)

I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.

Technical Cognizance

Requirements Cognizance

CONTRACTING OFFICER CERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge.

LEGAL SUFFICIENCY REVIEW AND CONCURRENCE

I have reviewed the facts set forth in the above Justification and Approval and find this J & A to be legally sufficient, based on these facts, to the best of my knowledge and belief.

APPROVAL BLOCK COMPETITION ADVOCATE

($650,000-$12.5M)