Justification and Approval - OVER SAT Hologic.pdf

OFOC SOP Revision 09 Page 1 of 5 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C241-20-AP-2211

1. Contracting Activity: Department of Veterans Affairs, VISN 01, VA Connecticut Healthcare System, 950 Campbell Street, West Haven CT 06516

PR-ICAP: 689-21-1-7455-0023

PR-ICAP: 523-21-1-7455-0008

The following VISN 1 Sites will be using the Reagents & Supplies.

VA Maine Healthcare System (402), 1 VA Center, Augusta ME 04330 VA Manchester Healthcare System (608), 718 Smyth Road, Manchester NH 03104 VA Boston Healthcare System (523), 1400 VFW Parkway, West Roxbury MA 02132 VA Providence Healthcare System (650), 830 Chalkstone Avenue, Providence RI 02908 VA Connecticut Healthcare System (689), 950 Campbell Avenue, West Haven CT 06516 VA White River Junction Healthcare System (405), 163 Veterans Drive, White River Junction VT 05009 VA Central Western Massachusetts Healthcare System (631), 421 North Main Street, Leeds MA 01053 VA Edith Nourse Rogers Memorial Healthcare System (518), 200 Springs Road, Bedford MA 01730

2.Nature and/or Description of the Action Being Processed: This request is a follow for Cytology Reagents and Supplies to equipment owned by the VISN 1 Healthcare Systems. This will be a 5-year Firm Fixed-Price BPA for testing supplies from Hologic. Cells are collected from urine specimens to see how they look and function. The test commonly checks for infection, inflammatory disease of the urinary tract, cancer, or precancerous conditions. The supplies are needed to aid specifically in the diagnosis of cancers for our female veterans’ population within the VISN 1 Healthcare System. It includes; collection kits, preservatives, reagents and supplies needed for the Thin Prep and Celient instruments. The Blanket Purchase Agreement period will be October 1, 2020 to September 30, 2025. The estimated annual cost will be $78,632.00 with a 5-year estimate of $393,160.00.

3.Description of Supplies/Services Required to Meet the Agency’s Needs: The Boston Cytotechnologist and Pathologists rely on the ThenPrep System to provide quality slides and blocks for diagnosing or ruling out various cancers. The reagents in the chart work in association with only Hologic equipment.

The below supplies will be called in to the contractor as needed pursuant to the designated purchase order. The below are only estimated annual quantities.

Part Number Description Est. Qty. Annual

236004 Cytolyt, 32 OZ bottle 4 pack 34 234004 Preservcyt 32 oz 4 pack 9 234005 Preservcyte 50 vial pack 98

70205-001 Filter, Thin prep NON GYN 100 pk 47 71305-001 Celient filter-cassette kit QTY 50 6

70096-003 Thinprep PAP testwith Cytobrush/spatula 2 236080 Cyto tubes, 80 pack 9

70137-001 Lab Supplies (GYN Lab Kit) 4 70372-001 Thinprep microscope slides, non gyn 100 pack 26 70136-001 GYN kits w/ brooms 500/case physician kit 1 70136-002 Thin-prep PAP & Brushes 500/case physician kit 1

236050 Cytolyt 50 ml cups, 50 cups/box 1 70124-001 GYN Brush and Spatula 1 70096-001 Thinprep test kit 1

4. Statutory Authority Permitting Other than Full and Open Competition:

( X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

5.Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The reagents listed in section #3 are specific to Hologic, and the ThinPrep Imaging System. The vendor is the sole manufacturer and distributor of these supplies. Hologic Incorporated (Large) is the only contractor capable of providing the supplies and service. They have no Service Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, or Small Businesses that can provide the products. VISN 1 Healthcare System Sites own the testing equipment. So only reagents are required. At this stage to change out contractors and equipment would cause disruption in service, and delay patient care. This testing platform has proven to be effective for the last 5-years in providing specialized care for female veterans that are experiencing a traumatic change in their life. This system is imperative for the Cytology Department to continue their mission.

6.Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Thermo Shandon is the only other known vendor providing equipment and supplies for the same type of testing. Switching to this system would involve a large investment in acquiring new equipment, training, and the risk of misdiagnosing patients by using a new system.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The estimated cost for the previous Blanket Purchase Agreement was $556,635.00. The cost included equipment and reagents. The estimated costs for reagents are $393,160.00. Hologic pricing was checked OFOC SOP Revision 09 Page 2 of 5

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Revision 09 Date: 04/17/2020 with their open market rates, which are consistent throughout the VISN. Due to considerable testing, which has already been validated and implemented with the Hologic system, no further cost would be incurred for this. As indicated the following equipment is in place; ThinPrep 2000 Processor, ThinPrep 3000 Processor, ThinPrep Imaging System, and all the ThinPrep disposables. No other vendors offer the Hologic reagents for the indicated equipment.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: The Hologic Thin Prep Imaging System is already in place and used in VISN 1. Searches were conducted on the following sites; Electronic Contracting Management System (eCMS), System Award Management Systems (SAMs), Federal Procurement Data System (FPDS), National Acquisition Center (NAC), North American Industry Classification System (NAICS), General Service Administration (GSA), Vendor Information Page (VIP), FedBizOpps (SSN), and contacting the manufacturer (Hologic Inc.). In searching eCMS, a 5-year Indefinite Delivery Contract (IDC) was created that expires September 30, 2020. In checking SAMs, Hologic Incorporated is a large business with no small business distributors for their products. Searched FPDS for ThinPrep PAP Tests, Hologic was the primary provider listed for the product. CYTYC Corporation was listed, but in searching SAMs under DUNs 153623137. The company was a subsidiary of Hologic Incorporated. Hologic is not listed on any of the Federal Schedules (NAC/GSA). Found 29 VIP contractors under NAICS/Keyword search. VIP RFI#AP2211 Reagents & Supplies for Thin Prep Imaging System was sent to all contractors. Sources Sought Notice was posted on FedBizOpps to gather additional market research. Spoke to Jennifer Shea, the Contract Analyst for Hologic Incorporated (8/12/20).

Request for Information (RFI) was sent to contractors on the Vendor Information Page (VIP). The 29 contractors were sent an e-mail requesting information. Received responses from AvMedical LLC (SDVOSB) and D’ Venture LLC (DBA: LogMet Solutions) (SDVOSB). AvMedical LLC indicated that they are not capable.

Hologic Incorporated is not listed on any Federal Schedules. An RFI was not posted on GSA. Hologic Incorporated is not listed on the NAC.

Sources Sought Notice was posted on Federal Opportunities under 36C24120Q0495. D’ Venture LLC (DBA: LogMet Solutions) submitted a quote, and an agreement they have with McKesson. D’ Venture LLC (DBA: LogMet Solutions) (SDVOSB) indicated that they could provide the reagents and supplies.

However, per Jennifer Shea’s August 11, 2020 e-mail they have no small business distributors for the reagents. A call was made to D’ Venture LLC (DBA: LogMet Solutions) on August 24, 2020. I spoke to Tarsha Lee, Director of Compliance. She indicated would call me back me back that day reference their claim of McKesson’s products being compatible to Hologic equipment and testing reagents. I did not hear back from Ms. Lee. Hologic Incorporated (Large) provided proprietary letters for reagents and equipment. Hologic Incorporated responded to the RFI with a quote listing all the reagents, and estimated cost per year.

There were (2) response from SDVOSBs. After review, both were deemed not capable of providing the reagents and supplies. The reagents and supplies are specific to Hologic Incorporated, and their testing equipment. This equipment has been in place since 2015 under BPA VA241-15-D-0188 with the equipment being owned by the VA Healthcare System Sites. Currently, the facilities are looking to continue using only the reagents and supplies. This is a follow-on to the previous BPA, and no other reagents can be used. In addition, the validation process has been completed for reagents on the equipment. Any changes in the contractor or equipment would take months to change out, re-train staff, and re-validate testing. The action would cause disruption in service and patient care. A

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2268/Limited Source Justification will be submitted for approval to purchase reagents direct from Hologic Incorporated.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The following are respective points to other than full and open; Equipment Owned and in place, Cost and disruption of changing contractors/equipment at this junction, re-validation of equipment and reagents would take several weeks to months causing a delay in patient care, and Staff re-training of equipment/procedures.

Finally, all of this could lead to a greater chance of making mistakes and possibly misdiagnosis. With the success of the current system. No further money needs to be invested into a new system.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: The current use of the Hologic testing and supplies and the VA owning much of the equipment makes it undesirable to change test platforms. However, the following contractors responded to the RFI, but were not capable of providing the specific product needed.

• AvMedical LLC (SDVOSB)

• D’ Venture LLC (DBA: LogMet Solutions) (SDVOSB)

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: If Hologic Incorporated changes their policy to allow other contractors to become distributors. The VA will seek them out. Secondly, if the service decides to change contractors prior to the expiration of the Blanket Purchase Agreement. The VA will seek out all options available.

12. 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 and belief.

David McElwee Date Program Support MT VISN 1 NCL Facility VA Brockton

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Julie Lemire Date Contracting Officer Manchester VAMC, NCO 1

David G.

McElwee 142454

Digitally signed by David G. McElwee 142454 Date: 2020.08.25 12:40:11 -04'00'

9/8/2020

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

Linda J. Ward Date Branch Chief – Commodities Team

Manchester VAMC, NCO 1