36F79719D0024-001.pdf

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

VHAPM Part 808.405-6 Limiting Sources Page 1 of 6 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C242-19-AP-1204

1. Contracting Activity: Department of Veterans Affairs Veterans Integrated Services Network (VISN) Region 2 Down State James J Peters Veterans Affairs Medical Center 130 W Kingsbridge Road Bronx, NY 10468

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). This Limited Sources Justification Request is for the approval to procure services through a sole source, firm fixed price, interim Blanket Purchase Agreement (BPA) awarded to the incumbent, Abbott Laboratories. The estimated value of this proposed action is $ for the base period of 6 months, and an additional $ for one 3-month period if needed. The period of performance will include:

Base Period: 01 April 2019 through and including 30 September 2019;

Option Period One (1): 01 October 2019 through and including 31 December 2019.

All required testing reagents provided by Abbott Laboratories. are available on their Federal Supply Schedule contract.

Order against: FSS Contract Number: 36F797-19-D0024

Name of Proposed Contractor: Abbott Laboratories

Street Address: 100 Abbott Park Road

City, State, Zip: Abbott Park, IL 60064

Phone: 212-348-3143

3. Description of Supplies or Services:

The estimated value of the proposed action is $$568,215.14

Cost-Per-Reportable Result (CPRR) testing for Hepatitis, HIV, Vitamin D and Immunosuppresive drug testing inclusive of the lease of equipment and the provision of all consumables, as well as the maintenance service needed for the effective operation of the equipment. This method will allow for pricing per reportable result on reagents for processing patient chemistry tests on Abbott chemistry and immunochemistry analyzers. These analyzers are currently in use for patient testing at the New Jersey, Bronx, NY Harbor and Northport laboratories. This testing is critical to the care provided to the Veteran patients as the various tests are used by the medical professionals for patient diagnosis and treatment.

The current VISN 2 Downstate FSS BPA number V797-7335A/VA243-12-A-0047 will expire on March 31, 2019. The Veterans Affairs (VA) National Acquisition Center’s (NAC) negotiation of a new Federal Supply Schedules 66 III Clinical Chemistry & Immunochemistry contract was awarded September 2018 but implementation of new analyzers and automations systems is expected to be completed by September 31, 2019. The implementation will not be completed by March 31, 2019 when the current contract ends. Therefore, an interim contract to ensure continuity of service to the Veterans is being requested.

(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.

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

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.

This proposed action is for unique and highly specialized testing services. The Abbott analyzers are the proprietary equipment of Abbott Laboratories. As such only reagents provided by Abbott are compatible with the analyzers currently in use at the New Jersey, Bronx, Northport and NY Harbor laboratories under FSS BPA number V797-7335A/VA243-12-A-0047(new FSS Number V797P-7323A). Additionally, the Abbott Laboratories analyzers have been specifically calibrated, the VISN 2 Down State laboratory personnel trained, and lab procedures written and implemented to produce consistent results and required testing. This functionality is crucial to the effective operation of VISN 2 laboratory testing and the successful completion of millions of tests annually at the aforementioned VISN 2 Down State medical facilities on Abbott Laboratories equipment. The time-intensive process involved in the transition of equipment as well as the preparation of staff and procedures resulting from a new award instead of the sole source award to Abbott Laboratories would result in critical mission failure in the VA medical professionals’ ability to provide the diagnostic and critical treatment to the Veteran patients.

Additionally, a long and complicated transition period is expected in the phasing out and demobilization of several manufacturers’ analyzers and streamlining to a single manufacturer analyzer for all chemistry and immunochemistry testing. In the interim patient testing cannot be interrupted. These analyzers are used to provide urgent as well as routine testing. The introduction of a new contractor at this time in lieu of the sole source award of this interim contract to Abbott Laboratories would result in a disruption of services in the Pathology and Laboratory Medicine departments and unacceptable delays in the VA’s care of Veteran patients.

VHAPM Part 808.405-6 Limiting Sources Page 2 of 6 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

VHAPM Part 808.405-6 Limiting Sources Page 3 of 6 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

We are currently in the final phase of instrument delivery and implementation planning and we anticipate completion of all phases by September 30, 2019. This interim contract will prevent a cessation of critical services for the first three months as well as the implementation phase of the new contract which is anticipated to take nearly a year. The installation and implementation phase are time-intensive processes that include:

* A vendor assessment of all of the VISN 2 Down State laboratories for the preparation of the assignment of appropriate analyzers;

* A lead time of several weeks for the ordering and delivery of equipment to four different VISN 2 Down State medical facilities;

* Changes to the laboratory facilities required to accommodate the new equipment which may include some minor construction;

* The phase in/out of new/old equipment involves both correlation and staff competency phases. In the correlation phase, the new equipment is installed;

concurrent tests are run on both old and new equipment;

reviews and analyses of the results are conducted;

calibration of new equipment to ensure continuity of results; and additional concurrent tests are run and evaluated until results are congruent.

In the staff competency phase, revisions to guidelines are initiated to educate the staff and ensure proper use of the equipment in the collection of data as follow:

o Policies are updated;

o Procedure manuals are revised; and o Training of multiple shifts of personnel in eight VISN 2 laboratory facilities.

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.)

VHAPM Part 808.405-6 Limiting Sources Page 4 of 6 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

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:

Abbott Laboratories has offered to extend the same pricing from the current FSS BPA V797P-7335A/ VA243-12-A-0047 (New FSS number V797P-7323A). This comparison will ensure that the proposed prices do not exceed those prices, and the Government will request a discount pursuant to FAR 8.405-4.

Abbott Laboratories has offered to extend the same pricing from the current FSS BPA to the new interim FSS BPA.

(6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE

RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED:

Market research was conducted through queries on the General Services Administration (GSA) eLibrary database, the US Department Veterans Affairs Office of Small & Disadvantaged Business Utilization Vendor Information Pages (VIP) of the VetBiz website, and the Small Business Administration Dynamic Small Business Search.

Special Notices were posted to eBuy and FBO of the intent to sole source. VIP and DSBS searches were conducted and no contractors found that could provide these specialized and unique services.

(7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION: N/A

(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:

This necessary sole source FSS-TO to ensure the continuity of testing services for Veterans prior to activation of the new long term BPA that was awarded in September 2018.

The new BPA was already awarded competitively and the effective date of the new BPA will be adjusted via modification to account for the extended period needed to install and activate the new analyzers.

VHAPM Part 808.405-6 Limiting Sources Page 5 of 6

Revision 01 Eff Date: 04/23/2018

Pathology and Lab Medicine

SERVICE LINE/SECTION

SIGNATURE DATE

TITLE

VISN 2 Down State, Northport NY

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.

CONTRACTING OFFICER/DESIGNEE’S SIGNATURE DATE

Contracting Officer NCO 2 ______________________________

NAME AND TITLE FACILITY

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

(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.)

Date: 2019.02.04 14:25:36 -05'00'

Date: 2019.02.05 11:59:00

-05'00'

VHAPM Part 808.405-6 Limiting Sources Page 6 of 6

Revision 01 Eff Date: 04/23/2018

DATESIGNATURE

NAME

NCO 2 /Supervisor NCO 2 Supply Team 1

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

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.

Date: 2019.02.05 11:50:59 -05'00'