36C24119A0013-000.docx

VHAPM Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT FedBizOpps Award Notice

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* = Required Field FedBizOpps Award Notice Rev. March 2010 Q Blood Testing - CSP590 2019 - 2024 Research Project 02301 36C24119Q0110 N 621511 Department of Veterans Affairs VA Boston Healthcare System Contracting Officer (90C) 940 Belmont Street Brockton MA 02301 Cheri Wicks (Email Only; No Phone Calls Please) cheri.wicks@va.gov 36C24119A0013 71,161.00 03-28-2019

QUEST DIAGNOSTICS INCORPORATED

056354640

500 PLAZA DR

SECAUCUS

NJ

07094 cheri.wicks@va.gov Contracting Officer cheri.wicks@va.gov Contracting Officer

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C24119AP0832

1. Contracting Activity: Department of Veterans Affairs, VISN 01, VA Boston Medical Center, Massachusetts Veteran Epidemiology Research and Information Center (MAVERIC), NCO1, 523-19-3-8183-0145

2. Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 251 and 40 U.S.C. 501). VA Cooperative Studies Program is continuing a study to evaluate the effectiveness of Lithium Extended Relief, in conjunction with enhanced usual care to reduce the rate of suicidal self-directed violence (repeated suicide attempts, interrupted attempts, hospitalizations specifically to prevent suicide, and deaths from suicide) in participants with bipolar disorder or depression who have survived a recent event. These blood tests will be used to monitor blood levels of Lithium and other associated blood components over the course of this long-term research study. This new requirement will be replacing contract VA241-15-A-0026 (there is also a VA nationwide contract with Quest Diagnostics V797D-70090 that is valid through March 31, 2022).

3. Description of Supplies or Services:

The estimated value of the proposed action is $ 297,928 over 4 years; however, the CO recommends awarding a 5-year BPA which brings the total estimated value to $355,805.

Vendor shall provide blood tubes appropriate for collection that possess unique barcodes, which can be used to create a crosswalk at the site between the tube and any PHI. Vendor personnel and laboratory shall be compliant with all applicable laws and regulations. Serum Lithium levels, Serum Creatinine levels and other blood components shall be tested and the results uploaded to designated web portal.

Over the duration of the contract roughly two hundred thousand samples will be analyzed.

(4) IDENTIFY THE AUTHORITY AND SUPPORTING RATIONALE (see 8.405-6(a)(1)(i)(A), (B), and (C) or 8.405-6(b)), AND IF APPLICABLE, A DEMONSTRATION OF THE PROPOSED CONTRACTOR’S UNIQUE QUALIFICATIONS TO PROVIDE THE REQUIRED SUPPLY OR SERVICE. (CHECK ALL THAT APPLY AND COMPLETE)

|_| An urgent and compelling need exists, and following the ordering procedures would result in unacceptable delays.

|X| Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

Quest Diagnostics has been the vendor for this study since 2015. Failure to continue the study with the same vendor would result in contaminated results. Contaminated results would mean that the study findings are unusable and therefore the potential benefit to veterans would be lost; the results and findings of the past 5 years would be invalidated. Quest Diagnostics’ National Contract (V797D-70090) with the Department of Veteran Affairs ensures the required laboratory certifications are current and the pricing is competitive. Quest is uniquely positioned because they have a centralized and fully automated lab that can accept blood vials from all over the country. This study is not limited to Veterans in the VABHS catchment area but rather serves Veterans nationwide. Additionally, Quest has the capability and capacity to provide the results of the Lithium levels within 48 hours. This feature is critical and ensures VA clinicians have the information they need to rapidly treat and prevent suicide events. It should also be noted that Quest Diagnostics was the only vendor that submitted a proposal when the requirement was released in 2015.

Market research indicates that LabCorp could possibly have the ability and capacity to handle the volume of samples. However, they do not have a GSA contract. Changing vendors 5 years into the research would invalidate the previous findings and render the funds already spent as wasted. Additionally, re-creating the highly successful processes, reporting portal, and mandatory turnaround time for Lithium results, with another vendor could cause unacceptable delays and possibly endanger the safety of Veterans.

|_| In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

|_| Items peculiar to one manufacturer:

|_| A patent, copyright or proprietary data limits competition. The proprietary data is: (If FAR 8.405-6(a)(2)iii before posting. Do not include specific proprietary data. Only mention the type of equipment, procedure, etc. to show that proprietary supplies or services are being procured.)

|_| These are “direct replacements” parts/components for existing equipment.

|_| The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system.

(5) DESCRIBE WHY YOU BELIEVE THE ORDER REPRESENTS THE BEST VALUE CONSISTENT WITH FAR 8.404(d) TO AID THE CONTRACTING OFFICER IN MAKING THIS BEST VALUE DETERMINATION:

Based on the initial (2015) market research, the pricing provided by Quest was in line with industry standards and GSA had determined the prices under schedule contract V797P-7105A were fair and reasonable. Price analysis of new proposed pricing will be done by comparing previous pricing to current pricing under schedule contract V797D-70090 for and a current determination of fair and reasonable pricing.

Best value is obtained through the continued use of a successful vendor, maintaining the validity of previous findings, and continuing to ensure the safety of Veterans by avoiding unacceptable delays.

(6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED:

A market research worksheet was submitted in 2015. Techniques used at the time were email and phone conversations with certified labs. The result was that there were two labs with the capability to fulfill the needs of the government. Those labs were LabCorp and Quest Diagnostics. Market research for the follow-on action indicates there is no other nation-wide, certified lab with the capability and capacity required. Search of the Vendor Information Pages resulted in 103 SDVOSB and VOSB under the NAICS of 621511. A review of a random selection of these vendors indicates there are no other vendors of providing the services offered by Quest Diagnostics.

(7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION:

The original (2015) FSS-RFQ was sent to seven (7) vendors and Quest was the only one who responded. Current market research indicates the market place has not changed significantly.

(8) A STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OR OVERCOME ANY BARRIERS THAT LED TO THE RESTRICTED CONSIDERATION BEFORE ANY SUBSEQUENT ACQUISITION FOR THE SUPPLIES OR SERVICES IS MADE:

Subsequent acquisitions for lab services that have no effect on the current long-term study could possibly be opened to full and open competition. Desired goals of the research project and market research would be factored into any future requirements.

(9) REQUIREMENTS CERTIFICATION: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

VHA Boston

FACILITY

(10) APPROVALS IN ACCORDANCE WITH THE VHAPM Part 806.3 OFOC SOP:

a. CONTRACTING OFFICER’S CERTIFICATION (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Lorrie Baines, Supervisory Contract Specialist Branch Chief, Services Team

NCO 1

VHAPM Part 808.405-6 Limiting Sources Page 5 of 5 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018