NCO17-FY23-299 JOFOC 36C257-23-AP-4057 HCA Approved.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification

Effective Date: 02/01/2022 Page 1 of 5

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C257-23-AP-4057 RPOW JOFOC Tracking Number: 2023-07-25T07:44:08

1. Contracting Activity:

Department of Veterans Affairs, Network Contracting Office 17 (NCO 17), located at 5441 Babcock Rd. Ste 302, San Antonio, TX 78240, in support of the South Texas Veterans Healthcare System (STVHCS), Pathology and Laboratory Medicine Service (P&LMS), located at 7400 Merton Minter Blvd., San Antonio, TX 78229.

Anticipated Purchase Request Number: 671-24-1-121-0038

2. Nature and/or Description of the Action Being Processed:

This procurement is for preprocedural SARS-CoV-2 (COVID-19) testing reagents in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. STVHCS has a need for COVID-19 Assay NAA reagents compatible with the government- owned Hologic Panther Instrumentation for continued in-house testing of patients and employees for continued surveillance for preprocedural and screening processes to reduce exposure in critical patient areas. The contract will be for a new Firm Fixed Price IDIQ with five one-year ordering periods.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The items below are the supplies required under this contract for the period of 11/1/2023- 10/31/2028 (five one-year ordering periods):

Item # Description/Part Number Qty

PRD-06419 Aptima SARS-CoV-2 Assay, 250-Test 40

PRD-06420 Aptima SARS-CoV-2 Controls 110

PRD-04339 Fusion Specimen Lysis Tube, 100 per bag 80

303096 Panther Run Kit (Contains 303014,303013,104772-02,902731,504405) 60

303014 Aptima Assay Fluids Kit 60

303013 Aptima Auto Detect Kit 60

104772-02 Multi-tube Units(MTU's) 70

902731 Panther Waste Bag Kit 10

504405 Panther Waste Bin Cover 10

303085 Advance Cleaning Solution 50

CL0041 Caps, AMP/P.R.S. (CL0045) Diag. 12

CL0040 Caps, TCR/SEL. (CL0038) Diag. 12

501604 Spare Caps, PP, 60mL, TCR Aptima 2x50 12

501616 Spare Caps, 30mL tube(501213)Diagnostics 12

105668 Aptima Penetrable Caps 888

The total estimated value for the IDIQ ceiling is $2,500,000.00.

Effective Date: 02/01/2022 Page 2 of 5

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

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 described in paragraph 3 above are the only reagents compatible with the Hologic Panther analyzer, which is only provided by one large business manufacturer, Hologic Sales and Service, LLC (Hologic). The reagents used for testing provide qualitative RNA detection of the COVID- 19 virus. The testing provided is part of the STVHCS COVID algorithm, which is the standard of care currently mandated by the VA for preprocedural patient and employee screening.

The analyzer that is in use at the facility is a highly specialized instrument. Selection of any other third-party reagents would invalidate warranties held on the analyzer and would invalidate all testing as the instrument has not been validated for third party reagent use by the Original Equipment Manufacturer (OEM), Hologic. The invalidation would cause unacceptable delays and lead to a substantial duplication in costs in patient care. This would be due to a need for a new analyzer, new reagents, a new service contract; while these contracts would be processed, testing would either have to be outsourced or patient procedures would need to be rescheduled for later dates.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Market research has been conducted in accordance with FAR part 10, VAAR part 810 and VA PPM 2016-05 (Revised AUG 2019).

Searches on SBA’s VetCert, Ability One, SBA’s DSBS, and an internet search engine were made to determine if there were any small businesses that provide COVID-19 reagents that are compatible with the Hologic Panther already in use at the STVHCS. No capable small business vendors were found to be able to provide the required reagents.

Additionally, the OEM, Hologic, was contacted to determine if there were any small business distributors authorized to provide the required reagents for the analyzer. The vendor responded with a sole source letter stating that no third parties are authorized to provide the required supplies and only the reagents listed in Section 3 above are used on the existing equipment.

Effective Date: 02/01/2022 Page 3 of 5

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

Pricing for this requirement will be determined fair and reasonable based upon a comparison to the current IDIQ pricing, 36C25721D0009. The current Hologic IDIQ’s COVID reagents pricing was previously determined fair and reasonable based upon a comparison to the pricing of other reagents on the IDIQ. Pricing will also be compared to a similar requirement, 36C25722D0040, an IDIQ for ThermoFisher COVID reagents. This IDIQ’s pricing was determined fair and reasonable based upon competition and a comparison to the IGCE.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted:

Market Research was conducted pursuant to FAR part 10, VAAR part 810, and PPM 2016-05.

SBA’s VetCert was searched using NAICS Code 325413. This resulted in 81 vendors- 79 SDVOSBs and 2 VOSBs. Of the vendors listed on VetCert, two (2) vendors provide reference laboratory testing, not reagents. Other vendors found did not appear to provide reagents.

Ability One was searched using keyword “reagents” and 0 vendors were found. UNICOR’s list of available products was reviewed; they do not provide reagents. SBA’s DSBS resulted in 8 vendors- 6 SDVOSB/VOSB, 3 WOSB (one is also SDVOSB), 1 8(a), and 1 SDB (also SDVOSB). Of the vendors found, none provided reagents for COVID-19 testing and some provided over-the-counter testing.

GSA eLibrary was searched using the key phrase “covid”. This resulted in 0 schedules. Two general internet searches for “hologic panther reagents covid” and “hologic panther covid reagents fda” were made. Both searches resulted in one (1) large business, Hologic.

The OEM, Hologic, was contacted directly to inquire as to whether or not the vendor authorizes third parties to provide the needed supplies or if there were any compatible reagents other than those manufactured by the OEM. The vendor responded with a sole source letter dated November 2022.

Similar market research from three actions was reviewed for this requirement. The first is for an “Occult Blood Instrument” (AP 36C257-23-AP-2677), the second was for a BioFire Torch Analyzer (AP 36C257-23-AP-2791), and the third for a “Hematology CPRR” (36C257-23-AP-3780). The results of these found that small businesses that provide the reagents (CPRR pricing or per test/kit) are very specialized, and most manufacturers of laboratory analyzers are large businesses.

The supplies for this contract are currently being provided under IDIQ order 36C25721D0009 36C25723N0022. The order was awarded to Hologic for $2,505,500.00 and expires on 10/31/2023.

An order to this IDIQ was considered. However, the estimated annual value of this order would exceed the IDIQ ceiling.

Based upon the market research results, only one vendor, the OEM, Hologic Sales and Service LLC is capable of providing the required reagents for the existing Hologic Panther analyzer.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

Orders for the COVID-19 reagents cannot be delayed. The STVHCS is currently in need of the testing reagents due to the ongoing need for COVID-19 testing. If the reagents are not received in a timely

Effective Date: 02/01/2022 Page 4 of 5 manner, scheduled appointments for the veteran will be delayed. To alter vendor and/or formulations will disrupt, if not negate patient care.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Hologic Sales and Service, LLC 250 Campus St.

Marlborough, MA 01752 Mindy Thiery

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:

A major barrier for this requirement is that the analyzers and reagents are not cross-compatible, in most cases. The average useful life for laboratory equipment is between five (5) and ten (10) years.

When this equipment has reached the end of its useful life, in two (2) to seven (7) years, there are multiple vendors found through market research that manufacture analyzers and reagents on the open market for COVID-19 testing. Ensuring that the expiration of the reagents contract is aligned with the end of the effective usefulness of the analyzer will allow for competition for both the new analyzer and reagents.

The planned award type for this action is an Indefinite Delivery Indefinite Quantity (IDIQ) contract action, which requires additional market research prior to each order being awarded. If a change in the marketplace is found or the analyzer has reached the end of its lifecycle prior to the award of a new order, then a new competitive solicitation can be considered in place of awarding the task order.

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.

Michael Noriega Date Chief Medical Technologist Pathology &Laboratory Medicine Service South Texas Veterans Healthcare System

Effective Date: 02/01/2022 Page 5 of 5

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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.

Delphia Schoenfeld Date Contracting Officer, Lab Support Team Network Contracting Office 17

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Michael J. Tusinger Date Branch Chief, Lab Support Team

c. Director of Contracting: I certify the justification meets requirements for other than full and open competition.

Mark A. Layman Date Director of Contracting

d. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $75 million) or approve ($750K to $75 million) for other than full and open competition.

Curtis M. Jordan Date Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA) https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx VHASTXSchoeD Typewritten Text 8/11/2023