36C244-25-AP-2457-2268 Molecular Testing signed.pdf

Department of Veterans Affairs SMALL BUSINESS PROGRAM AND

CONTRACT BUNDLING REVIEW

OSDBU CONTROL NUMBER

CONTRACTING ACTIVITY AND PROGRAM OFFICE DATA

1A. CONTRACTING ACTIVITY 1B. ADDRESS (Include Street, City, State and Zip Code)

1C. TELEPHONE NUMBER (Including Area Code) 1D. CONTRACTING POINT OF CONTACT NAME AND EMAIL ADDRESS

2A. NAME AND ADDRESS OF PROGRAM OFFICE 2B. PROGRAM MANAGER NAME AND EMAIL ADDRESS

3. REVIEW TYPE

INITIAL MODIFICATION

PROCUREMENT DATA

4. DESCRIPTION OF SUPPLIES OR SERVICES 5. EST. DOLLAR VALUE

A. BASE YEAR B. TOTAL

6A. NAICS AND SIZE STD. 6B. PSC

7. SOLICITATION NUMBER 8. PERFORMANCE PERIOD 9. EST RELEASE DATE 10. EST AWARD DATE

11. PROPOSED METHOD OF PROCUREMENT (Check all that apply) SOLE SOURCE SET-ASIDE PARTIAL SET-ASIDE

SDVOSB

VOSB

WOSB

EDWOSB

HUBZONE

8(a)

SMALL BUSINESS

OTHER (Affiliate, Ability One, etc.)

UNRESTRICTED-INSUFFICIENT SMALL BUSINESS (Attach justification)

FEDERAL SUPPLY SCHEDULE (FSS) NAME/#

MULTIPLE AWARD CONTRACT, TYPE/#

12. MARKET RESEARCH/PUBLICATION EFFORTS 13. MARKET RESEARCH RESPONSES (Actual Number)

POSTED

FCO

SBA VETCERT

SOURCES

SOUGHT

GSA EBUY

DSBS

SAM

RFI CONT OPPS

FPDS

SDVOSB

HUBZONE

VOSB

SMALL BUSINESS

WOSB/EDWOSB

LARGE BUSINESS

SDB/8a

OTHER

14. IPT REQUIRED? 15. PCR ASSIGNED? 16. BUNDLING CHECKLIST REQUIRED? (Attach VA Form 2268a) 17. SUBCONTRACTING PLAN REQUIRED?

YES NO YES NO YES NO YES NO

PROCUREMENT HISTORY

18. WAS ITEM PREVIOUSLY 19A. CONTRACTOR NAME AND ADDRESS 19B. BUSINESS TYPE

AWARDED?

YES (Complete 19-23)

NO (Skip to item 24)

SDVOSB

VOSB

SDB/8a

SMALL BUSINESS

WOSB

EDWOSB

OTHER

HUBZONE

LARGE BUSINESS

20. DOLLAR VALUE 21. PERIOD OF PERFORMANCE 22. NAICS/SIZE STD. 23. PROCUREMENT METHOD

24.COMMENTS

COORDINATION/CONCURRENCES

25.CONTRACTING OFFICER (Print), SIGNATURE DATE SIGNED

26.HEAD OF CONTRACTING ACTIVITY (HCA) OR DELEGATE (Print), SIGNATURE DATE SIGNED

27.SMALL BUSINESS LIAISON (Print), SIGNATURE DATE SIGNED

28.VA OSDBU REPRESENTATIVE (Print), SIGNATURE DATE SIGNED CONCUR NON-CONCUR (Attach narrative documenting reasons for non-concurrence and recommendations)

29. SUBCONTRACTING GOALS (%)

____ SDVOSB ____ VOSB ____ HUBZONE ____ SDB ____ WOSB ____ SB

30. NAME AND EMAIL ADDRESS OF SBA PCR (If assigned): 31. OTHER APPROVING AUTHORITY (as required): DATE SIGNED

VA FORM

JUN 2013 2268

Department of Veterans Affairs Network Contracting Office 4

Services 5 1111 East End Boulevard Wilkes-Barre PA 18711

570-479-0225 Christa Stine christa.stine@va.gov

VA Pittsburgh Healthcare System

1 University Drive Pittsburgh PA 15240

Cathy Noble cathy.noble@va.gov

X

Molecular Diagnostics Analyzer System and Reagents HIV/HCV Testing-Roche Cobas 6800 System $361,786.84 $1,808,934.20

334516 1000 Employees Q301

36C24425Q0574 06/12/2025-06/11/2030 05-16-2025 06-03-2025 X

X Roche Diagnostic V797D-70105

X

X

X

X

X

0 0 0 0

0 0 1 0

X X X X

X

Roche Diagnostics Corporation 9115 Hague Road

Indianapolis IN 462556 X

$1,565,521.30 06/12/2020-06/11/2025 325413 1250 Employees Sole Source

Roche Diagnostics Corporation is the only known source for these reagents. The acquisition is for reagents for analyzers already on hand at the hospital, no other supplies will satisfy this requirement. NAICS 334516 is most appropriate. Only one source is capable of providing the supplies or services required. SBA DSBS was queried and found no capable SDVOSBS or VOSBs. The approved Justification accompanies this review.

Victoria Droz 05-15-2025 xx

Department of Veterans Affairs CONTRACT BUNDLING CHECKLIST

NOTE: This checklist serves as a quick reference source for the members of the acquisition strategy team.

Please include this checklist with the required documentation sent to OSDBU.

NO. QUESTION ANSWER

1. Does the requirement exceed $1 million? YES NO

2. YES NO Will this requirement result in a consolidated or bundled contract?

See FAR 2.101

3. YES NO If the requirement is bundled, did the team avoid unnecessary and unjustified bundling?

See FAR 7.103(s)(2)

4. YES NO Did the team document in the plan of action any potential impact on Small Business?

See FAR 7.105(b)(1)

5. YES NO Before issuing the solicitation, did the team conduct a benefit analysis?

See FAR 7.107(e)

6. YES NO If the requirement is bundled, are the benefits "Measurably Substantial?"

See FAR 7.107(b)

7. YES NO Are reductions in either administrative or personnel costs the basis for the benefit analysis?

See FAR 7.107(d)

8. YES NO If the benefit analysis did not meet the FAR criteria, is the procurement mission critical?

See FAR 7.107(c)

9. Was notice of intent synopsized? YES NO

10. Were comments received? YES NO

11. YES NO Were alternatives considered and noted in the contracting officer's justification for bundling?

See FAR 7.107(e)(6) and 7.107(f)

VA FORM 2268a JUN 2013 x

Market Research And Acquisition Planning Report

VHAPG Part 810.001 Market Research Page 1 of 12 Revision: 04 Effective Date: 10/01/24 Acquisition ID#: 36C244-25-AP-2457

Title of Requirement: HIV/HCV/HPV | ROCHE 6800

PART I –

I. Authority.

Market research and acquisition planning are required in accordance with:

FAR 7.102, Acquisition Planning Policy FAR 7.103(u)(1) and (2), Agency-Head Responsibilities FAR 10.001, Market Research Policy VAAR 810.001-70 (Class Deviation), Market Research VAAM M810, Market Research VAAR 813.003-70(c), Policy (Class Deviation) FAR 19.202-2, Locating Small Business Sources and VAAR 819.202 (Class Deviation) FAR 25, Foreign Acquisition

II. Procurement Information.

A. Procurement History.

The contract was previously procured by Roche Diagnostics Corporation, a Large Business. VAPHCS currently uses the Cobas 6800 and only Roche equipment and reagents are compatible. This is a follow-on acquisition:

36C24420P0596. This is not a bundled requirement. There are not any known applicable Organizational Conflicts of Interest.

B. Procurement Background. Current 5-Year Purchase Order expires 06/11/2025.

Name Title Office Telephone E-mail Address

Cathy Noble Lab Contract Manager

VAPHCS Cathy.noble@va.gov

Type of acquisition: Supply of Laboratory equipment, reagents, supplies for molecular infectious disease testing.

Expected dollar value of requirement including option years: $1,808,934.20 Suggested NAICS code(s) : 334516 Time frame in which the market research was conducted: 12 months

III. Initial Requirements

VHAPG Part 810.001 Market Research Page 2 of 12 Revision: 04 Effective Date: 10/01/24 Acquisition ID#: 36C244-25-AP-2457

Describe the Government’s requirement in terms of:

o Functions to be performed: See Performance Work Statement (PWS) o Services or Performance required: See (PWS) o Inherently governmental functions and/or: See (PWS) o Essential physical characteristics: See (PWS)

Describe schedule requirements, e.g., performance periods and/or delivery due dates.

This will be a 5-year ordering order with unilateral task orders.

Period of Performance (POP):

Year 1: 06/12/2025-06/11/2026 Year 2: 06/12/2026-06/11/2027 Year 3: 06/12/2027-06/11/2028 Year 4: 06/12/2028-06/11/2029 Year 5: 06/12/2029-06/11/2030

OPTIONS: N/A

Discuss any cost effectiveness issues associated with the requirements:

Pricing shall be established against manufacturer costs. A fair and reasonable determination shall be made prior to award.

IV. Participants in Market and Acquisition Planning Research

Describe the involvement of the individual Acquisition Team members and any other participants in the market research effort.

NAME TITLE OFFICE TELEPHONE E-MAIL ADDRESS MARKET

RESEARCH

ROLE

Cathy Noble

Program Official

VAPHCS

Lab

Cathy.noble@va.gov

POC

Victoria Droz Contracting

Officer (CO)

NCO4-

Services

Victoria.droz@va.gov

CO

Christa Stine Contract

Specialist

NCO4

Services

Christa.stine@va.gov CS

V. Market Research Techniques and Sources

VHAPG Part 810.001 Market Research Page 3 of 12 Revision: 04 Effective Date: 10/01/24 Acquisition ID#: 36C244-25-AP-2457

A. Market Research Techniques Describe techniques and sources used during market research. The following table may help structure and summarize the techniques used in the market research effort.

Check X

IF USED

SOURCES USED IN MARKET RESEARCH

DETAILS OF

RESEARCH/COMMENTS

RESEARCH SOURCES

(INCLUDE REFERENCES TO

ATTACHMENTS TO REPORT)

(e.g., List of Journals and Literature Reviewed included as Attachment 4 to this report)

X Acquisition history reviewed Reviewed previous and current contract 36C24420P0596

Other recent market research reviewed N/A

X Veteran Small Business Certification (VetCert) (including any information supporting price reasonableness)

Total of (0) small business concerns in each of the individual socioeconomic group in NAICS 34516, keyword “Molecular Testing”

Interviewed knowledgeable individuals in industry/Government

N/A

Participated/Attended Tradeshows and Industry Conferences

N/A

Professional Journals, Catalog and/or Product Literature reviewed

N/A

Participated in Small Business Vendor Outreach Sessions

N/A

B. Market Research Sources. In accordance with FAR Part 10 and VAAR Part 810, market research has been conducted for this acquisition. The following additional collaborative Contracting Officer-led techniques were used:

SOURCES REVIEWED

(IAW FAR 8.002, VAAR 808.002, FAR 8.003, FAR 8.004, and

VAAR 808.004-70)

VHAPG Part 810.001 Market Research Page 4 of 12 Revision: 04 Effective Date: 10/01/24 Acquisition ID#: 36C244-25-AP-2457

MARKET RESEARCH FOR SUPPLIES

Insert

X if Check ed

Details of Research/Com ments (Include N/A if not applicable)

MANDATORY GOVERNMENT SOURCES

IN PRIORITY ORDER

See VAAR 808.002 for further guidance on other mandatory

Government sources

(Include References to

Report Attachments)

1. VA Inventories including the VA supply stock program (41 CFR 101-26.704) and VA excess.

2. Excess from other agencies (See FAR subpart 8.1) N/A

3. Federal Prison Industries (FPI) (See VAAR 808.603 Purchase Priorities)

4. Supplies from Ability One - (AbilityOne Program) (FAR 8.002)

X 5. Wholesale Supply Sources (GSA website:

https://www.gsaglobalsupply.gsa.gov/advantage/main/start_ page.do?store=FSS)

V797D-70105

See VAAR 808.002 for further guidance on other mandatory Government sources

Insert X if Checked

VETERANS FIRST CONTRACTING PROGRAM

(VAAR subpart 819.70)

REFERENCES/SOURCES CHECKED

(IDENTIFYING VetCert CERTIFIED SDVOSBs/VOSBs)

Details of Research/Comments (Include References to Report Attachments)

X U.S. Small Business Administration, Veteran Small Business Certification (VetCert)

0 Results

X System for Award Management (SAM) search for entity records at: SAM.gov | Search

Roche’s Representations and Certifications are current through 02/06/2026

VHAPG Part 810.001 Market Research Page 5 of 12 Revision: 04 Effective Date: 10/01/24 Acquisition ID#: 36C244-25-AP-2457

Check X if Part of Research

PRIORITY CONSIDERATION OF

VA EXISTING CONTRACTS

1. See VA PPM (2016-05)(Revised AUG 2019) - Implementation of the Veterans First Contracting Program (VIEWS 01368239) concerning consideration of existing VA contracts and VA strategic sourcing regarding supplies in FSC Groups 65 and 66.

X 2. Other VA Existing Contracts (non-mandatory but their potential availability, scope, contract type, etc., should be documented in the market research report)

36C24424F0411 36C24420F0640

Check X if Part of Research

CONSIDERATION OF NON-VA EXISTING

CONTRACTS

Federal Strategic Sourcing Initiatives or OMB

Category Management contracts/sources

(Non-Mandatory except where OMB or Agency policy states otherwise)

1. Non-VA Contracts:

(Includes NASA-SEWP and BPAs under FSS Strategic Sourcing Initiative (FSSI) non-mandatory Federal Supply Schedules (other than for FSC Group 65 and 66) (FAR 8.004(a)(1) and VAAR 808.004-70).

2. Non-mandatory Federal Supply Schedules (non-VA) (See FAR 8.004(a)(1) and VAAR 808.004-70, Use of non-mandatory sources by VA (Class Deviation).

VHAPG Part 810.001 Market Research Page 6 of 12 Revision: 04 Effective Date: 10/01/24 Acquisition ID#: 36C244-25-AP-2457

Use of Other Sources Commercial sources (includes educational and non-profit institutions) in the open market. This is permissible IAW FAR 8.004 and VAAR 808.004-70.

N/A

Check X if Part of Research

Sources for services to consider, as applicable and as required

Details of Research/Comments (Include References to Report Attachments)

MARKET RESEARCH FOR SERVICES

1. Services that are on the Procurement List maintained by the Committee for Purchase from People who are Blind or Severely Disabled (AbilityOne) (See FAR subpart 8.7) See VAAR 808.002, Priorities for use of mandatory Government sources, paragraph (a)(2) pertaining to Services.

2. Services: Federal Prison Industries (See FAR subpart 8.6) UNICOR Home Page (Except if two or more SDVOSB or VOSB are identified, see

VAAR 808.603)

3. Also see--VA Federal Supply Schedules (FSS) in FSC Group 62I.

4. And see--mandatory sources reviewed, if applicable, for:

4a. Public Utility Services (see FAR part 41);

4b. Printing & Related Supplies (see FAR subpart 8.8);

4c. Leased Motor Vehicles (see FAR subpart 8.11);

NA

5. Services: Commercial sources (includes educational and non-profit institutions) in the open market.

VETERANS FIRST CONTRACTING PROGRAM

(VAAR subpart 819.70)—REFERENCES/SOURCES

CHECKED

VHAPG Part 810.001 Market Research Page 7 of 12 Revision: 04 Effective Date: 10/01/24 Acquisition ID#: 36C244-25-AP-2457

Sources Sought Notices: Requests for Information (RFI) SAM.gov | Contract Opportunities

Only Roche reagents can be used on Roche equipment

X System for Award Management (SAM) search for entity records at: SAM.gov | Home

Roche’s Representations and Certifications are current through 02/06/2026

OTHER REFERENCES/SOURCES CHECKED

(Other ways to conduct or confirm market research)

X Sources Sought Notices: Requests for Information (RFI) SAM.gov | Contract Opportunities

Intent to Sole Source was posted to https://sam.gov 36C24425Q0574

Pre-solicitation and/or Pre-Proposal Conferences N/A

Existing intra-/inter-agency contract vehicles, e.g.

Interagency Contract Directory (ICD) at:

https://www.contractdirectory.gov/contractdirectory

N/A

X System for Award Management (SAM) search for entity records at: SAM.gov | Search

Roche’s Representations and Certifications are current through 02/06/2026

X SBA Dynamic Small Business Database at: SBA - Dynamic Small Business Search

Total of (0) small business concerns in each of the individual socio-economic group in NAICS 334516 and keyword “ Molecular Testing”

Department of Labor (DoL) Service Contract Labor Standards (Service Contract Act (SCA)) and Wage Rate Requirements (Davis-Bacon Act (DBA)) wage determination information online at: SAM.gov | Wage Determinations (SERVICES ONLY)

VHAPG Part 810.001 Market Research Page 8 of 12 Revision: 04 Effective Date: 10/01/24 Acquisition ID#: 36C244-25-AP-2457

VI. Identify Product/Services and Sources Able to Meet the Requirement Identify or describe:

o Product/Service, include any brand name product information: Roche hereby confirms that the Roche Molecular Diagnostic (RMD) products are proprietary to Roche Diagnostics Corporation (RDC) and only available for purchase in the United States directly from RDC. The RMD product portfolio is not available through any Veteran Owned Small Business (VOSB) distributor or any other distributor, regardless of size.

o Product/Service characteristics and/or capabilities: The VAPHCS currently has a Roche Cobas 6800 system installed that provides leading throughput, increased flexibility, and absolute automation through a modular approach to the PCR workflow. The Cobas 6800 reduces operating time and labor to a fraction of what it used to be.

o Company information:

Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 462556

Patrick Murphy 609-636-5443 Patrick-e.murphy@roche.com

Company characteristics, past performance, and business size category: The Microbiology section has been using Roche Cobas 6800 equipment platform for the last 10 years. Large Business. CPARS lists 643 contract actions for Roche Diagnostics Corp. All ratings are either exceptional, very good or satisfactory. They have no terminations for cause or convenience.

o If sole source, describe efforts to locate additional sources: 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; The Cobas 6800 can only use Roche Molecular reagents. Testing has been validated and employees have been trained on existing equipment. New equipment would result in a 3-month side by side validation which would have an impact on patient car

Business Category Name of Potential Source(s)/Other POC Information

VetCert certified Service-Disabled, Veteran-Owned (SDVOSB)

VetCert certified Veteran-Owned Small Business (VOSB)

VHAPG Part 810.001 Market Research Page 9 of 12 Revision: 04 Effective Date: 10/01/24 Acquisition ID#: 36C244-25-AP-2457

Woman-Owned Small Business (WOSB) 0 Economically Disadvantaged Woman- Owned Small Business (EDWOSB)

HUBZone Small Business 0 Section 8(a) small business 0 Small/disadvantaged business (SDB) 0 Small business 0

Large Business Roche Diagnostic from FSS Pricing. POC Patrick Murphy

VII. Description of the Commercial Marketplace and Prevalent Business Practices

Describe the marketplace: The marketplace for clinical molecular diagnostic platforms is limited.

Identify availability of commercial or non-developmental items that satisfy requirements (value or shortcomings of each) and sub-components

State Nonmanufacturer Rule (NMR) Findings (if the acquisition is for manufactured products or other supplies) (See the Nonmanufacturer Rule Decision Tree to assist with this determination):

Identify standard/customary terms and conditions and industry business practices that differ from the standard Government practices (include information on payment, freight delivery, acceptance, and warranties): The cost of the rental equipment is included in the cost of reagents for the life of the contract.

Discuss if contract financing is applicable. If so, ensure compliance with FAR 32.202-3, Conducting Market Research About Financing Terms N/A Discuss any regulations unique to the requirement, if known None

VIII. Pricing and Market Issues

Identify price sources (e.g., market price, catalog, GSA, etc.), price ranges, and price variations: FSS Pricing, the anticipated cost is considered fair and reasonable based on historical contract pricing and in comparison, to the IGCE.

Describe market trends for product or service, e.g., technical, business, and pricing

IX. Other Considerations

Identify other considerations gathered from market research, e.g., opportunities for small business participation: It was determined that only Roche Diagnostics Corporation reagents can be used on Roche equipment.

Discuss *evaluations and/or qualifying factors, including such issues as past performance, references, product testing or evaluation, customer satisfaction, warranties, and quality problems. *For any "Best Value" procurement, indicate the factors to be used for evaluation. When soliciting quotations or offers, COs are

VHAPG Part 810.001 Market Research Page 10 of 12 Revision: 04 Effective Date: 10/01/24 Acquisition ID#: 36C244-25-AP-2457 required to notify potential quoters or offerors of the basis on which award will be made (price alone or price and other factors, e.g., past performance and quality).

Describe consideration of green (sustainable products and services) https://sftool.gov/greenprocurement and GSA’s Buy Green Products, Services, and Vehicles. Include discussion of energy efficiency standards of market products, if applicable

Discuss consideration to Buy American Statute. Determine if the Buy American, Trade Agreement or an Exception to Buy American apply by using the Buy American Decision Tool Clause and Provision Selection (FAR Part 25). Are there domestic end products available for this acquisition?

Discuss compliance with the VA FITARA Acquisition Compliance SOP

X. Market Analysis Summary

Market Research was limited dure to the nature of this requirement. However, a quote was obtained by Roche Diagnostics Corporations as well as a sole source letter which confirms that the Roche Molecular Diagnostic (RMD) products are proprietary to Roche Diagnostics Corporation (RDC) and only available for purchase in the United States directly from RDC. Both of these documents have been uploaded to the briefcase.

Market research was completed utilizing Veterans Certify search with the NAICS code 325416 and keywords Molecular Testing. There were no positive results. The contract specialist additionally utilized FPDS, eCMS, and GSA to review past contracts awarded for Molecular Testing. 36C24420P0596, 36C24424F0411, and 36C24420F0640 were found. As obtained, market research determined that Roche Diagnostics Corporations, a Large Business, is the only capable source at this time.

XI. DETERMINATION: Based on market research, only one source can meet the medical need to provide the materials, and the quality control required.

I. Contracting Officer Responsibilities:

I. Background. The codes identified below will be used when advertising this requirement, if applicable.

Title See Above Provide a brief description of the requirement to include any relevant history.

Product or Service Code ______See Above_____________ North American Industry Classification System (NAICS) See Above Estimated Contract Value (including options): $See Above Procurement History. See Above In accordance with FAR 7.102, contracting officers and acquisition planners are required to perform acquisition planning and conduct market research. The following information is a summary of the acquisition planning: In submitting this request for procurement, the customer considered available sources within the agency, any

VHAPG Part 810.001 Market Research Page 11 of 12 Revision: 04 Effective Date: 10/01/24 Acquisition ID#: 36C244-25-AP-2457 government furnished information/property, and security considerations IAW VA Handbook 6500.6. The contract type for this procurement is (Insert Contract Type) and the milestone schedule will be accomplished and documented in the Electronic Contract Management System (eCMS).

See Above

II. Market Research

1. Techniques Used in Conducting Market Research:

Market Research Techniques in Section J of the Guide.

2. Results of Market Research: See Above

III. Consideration of Small Business Opportunities

The VA’s contracting order of priority is set forth in VAAR 819.7005: Contracting officers shall consider, in the following order of priority, contracting preferences that ensure contracts will be awarded—

- To SDVOSBs

- To VOSB, including but not limited to SDVOSBs,

- To small business concerns using the priorities and preferences in VAAR

819.203-70 and VAAR subpart 819.70—

Based on above Market Research, identify each Small Business (including its eligibility for specific socioeconomic category status) capable of performing or providing the requirement. Discuss and explain the potential for Small Business participation in this acquisition.

IV. Conclusions and Recommendations

A. Query of the Vendor Information Pages (VetCert) Database at https://veterans.certify.sba.gov/ resulted in:

Total of ____0__ small business concerns in each of the individual socio-economic group in NAICS __334516_________:

SDVOSB

VOSB

Identify the number and types of small businesses contacted.

Identify which if any of the small business has the necessary technical capability.

VHAPG Part 810.001 Market Research Page 12 of 12 Revision: 04 Effective Date: 10/01/24 Acquisition ID#: 36C244-25-AP-2457

B. Query of the SBA Dynamic Small Business Search (DSBS) tool, resulted in:

Total of __0____ small business concerns in each of the individual socio-economic group:

SDVOSB

VOSB

Woman-Owned Small Business (WOSB) 8(a) HUBZone

SB

C. For acquisitions above the SAT, describe considerations for a set-aside or sole source award under the following small business program set-asides:

No small business programs under set-asides available for this acquisition.

D. When a total small business set-aside seems appropriate, describe why a set-aside is not appropriate for:

Only one source available due to the nature of this requirement. Source is a large business.

V. PROPOSED PROCUREMENT METHOD

Based on market research conducted, only one source appeared capable to fulfill this requirement, and qualified for a sole source of the procurement. Therefore, it is recommended to sole source the requirement to the only capable company, Roche Diagnostics Corporation. This market research information is not more than 12 months old.

Prepared by:

Name: ________________________________ Date: __________________ Contracting Specialist

Approved by:

Name: ________________________________ Date: __________________ Contracting Officer

Special Notice

*= Required Field Special Notice

SUBJECT* Intent to Sole Source Molecular Testing Reagent Rental | HCV, HIV, HPV, and CMV Cobas 6800 VA Pittsburgh Healthcare System

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 18711

SOLICITATION NUMBER* 36C24425Q0574

RESPONSE DATE/TIME/ZONE 04-18-2025 10:00 EASTERN TIME, NEW YORK,

USA

ARCHIVE 30 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

PRODUCT SERVICE CODE* Q301

NAICS CODE* 334516

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

Network Contracting Office 4

Services 5

1111 East End Boulevard

Wilkes-Barre, PA 18711

POINT OF CONTACT*

Contract Specialist

Christa Stine christa.stine@va.gov

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS christa.stine@va.gov

EMAIL DESCRIPTION

DESCRIPTION

INTENT TO SOLE SOURCE

The Department of Veterans Affairs, Network Contracting Office 4 (NCO4) intends to sole source a contract for Molecular Testing of HCV, HIV, HPV, and CMV testing, including Quality control, reagents, and the cost of all reagents of molecular testing of HCV, HIV, HPV, and CMV for the Cobas 6800. All work is to be completed in accordance with the Performance Work Statement. This sole source contract will be solicited and negotiated with Roche Diagnostics, 9115 Hague Road, Indianapolis, IN under the authority of FAR 13.106-1 – Single Source Justification.

See attached Draft Statement of Work (SOW).

The North American Industry Classification System (NAICS) code for this procurement is 334516. The Small Business Administration (SBA) size standard is 1000 employees.

Interested vendors that can meet this requirement, shall identify their interest and capability, and respond to this notice by 04/18/2025 by 10:00 AM EST. Interested vendors must send a capability statement, no more than one page in length; to include Company Name, ueiSAM Number, Socioeconomic Category, brief description of your business entities capability to handle this project at the Lebanon VA Medical Center.

This Special Notice of Intent to Sole Source is for planning purposes only. No solicitation will be made available. This is not a request for quotations. All information shall be provided at no cost or obligation to the Government. Responses must be sent via email to the Contracting Specialist at christa.stine@va.gov.

Responses received will be evaluated; however, a determination by the Government not to compete the proposed procurement based upon the responses to this notice is solely at the discretion of the Government. If no responses are received, Contracting will proceed with the sole source negotiation with Pharmacy OneSource, INC.

PERFORMANCE WORK STATEMENT (PWS)

DEPARTMENT OF VETERANS AFFAIRS

VA Pittsburgh Health System

1.0 INTRODUCTION AND SCOPE

OVERVIEW

The purpose of the VA Pittsburgh Healthcare System requirement is to provide best value professional and healthcare for molecular testing of HCV, HIV, HPV, and CMV.

1.2 SCOPE

mailto:christa.stine@va.gov

The contractor shall provide all resources necessary to accomplish the deliverables described in this Performance Work Statement (PWS) for molecular testing of HCV, HIV, HPV, and CMV testing, including Quality control, reagents, and the cost all reagents of molecular testing of HCV, HIV, HPV, and CMV. Shipping and handling charges would be factored into the cost of the reagents. The molecular testing must be compatible with the Cobas 6800 which is our current analyzer for molecular testing.

2.0 GENERAL INFORMATION

2.1 Type of Contract

The U.S. Department of Veterans Affairs, Pittsburgh VA Medical Center anticipates a Reagent Rental Usage Agreement from this Request for Quote using FAR Part 12 Commercial Item procedures. Pittsburgh VAMC will issue a reagent usage (Reagent Rental) for instrument use, supplies, installation, training, and servicing of the equipment (for the life of agreement).

2.2 Contract Ordering Period

The Reagent Usage Agreement will consist of a 12-months base period with four (4), 12-months options. The performance period will commence upon the Contracting Officer’s signature and will expire within one (1) year unless canceled, terminated, or extended.

2.3 Place of Performance

The place of performance will be VA Pittsburgh Healthcare System, University Drive C, Pittsburgh, PA 15240.

2.4 Travel

Travel may be required from contractor to implement and deploy reagent rental contract of molecular testing of HCV, HIV, HPV, and CMV which may include testing, training, installation, and servicing of equipment.

2.5 Hours of Contractor Operations (Government-Provided Work Site)

Work performed on molecular testing of HCV, HIV, HPV, and CMV instrumentation is issued under this contract are anticipated to occur Monday through Friday, within the hours of 0600 Eastern Standard Time (EST) and 1700 EST, except as authorized by the COR. VA observes all federal holidays as recognized by the Office of Personnel Management (http://www.opm.gov/fedhol/index.htm). Services performed at the Government’s site must not occur on Federal holidays or weekends, unless authorized in advance by the COR, or anytime the Government offices are closed. These parameters may be the contractor may be required to provide back-up coverage during periods of extended absences of assigned contractor personnel (five or more workdays) to ensure continuity of services.

2.6 Government-Furnished Information, Equipment, and Facilities

Government-Furnished Information (GFI), Government-Furnished Equipment (GFE), and Government- Furnished Facilities (GFF), if applicable, will be specified as necessary by each individual task order. VA implements and enforces, two-factor authentication (2FA) for all remote access to its networks. Network access through the Citrix Access Gateway (CAG) will require the use of a personal identity verification (PIV) card to complete the login process. The only method for users to access the VA network is with a PIV card.

The Contractor shall request other Government documentation deemed pertinent to the work accomplishment directly from the Government officials with whom the Contractor has contact.

The Contractor shall consider the COR as the final source for needed Government documentation when the Contractor fails to secure the documents by other means. The Contractor is expected to use common knowledge and resourcefulness and when in doubt, shall ask the COR.

3.0 SERVICE GROUPS AND LABOR CATEGORIES

3.1 General Requirements

Contractor personnel shall have the level of experience necessary to accomplish the requirements of this PWS. In addition, contractor personnel shall be acceptable to the Government in terms of personal and professional conduct, and in technical knowledge.

Furthermore, contractor personnel are expected to be proficient in using office automation equipment and software and have sufficient written and verbal communication skills to support VA program offices, their customers, and any other VA organizations. Should any contractor personnel be determined to be unacceptable in terms of technical competency or unacceptable conduct or behavior while on-site or while working on contract activities, the contractor shall immediately remove and replace the unacceptable on-site personnel at no additional cost to the Government. Contractor personnel are to serve in a support role; therefore, final decisions regarding inherently governmental functions will always be made by Government personnel.

General and technical requirements:

General Specifications:

The cost of the molecular analyzer would be factored into the cost of the reagents.

The contractor must provide reagents and quality control for molecular testing of HCV, HIV, HPV, and CMV.

Materials with the longest outdates will be shipped when the order is placed.

Materials will be scheduled for shipment according to the needs of the Microbiology/Molecular department.

All reagents including quality control material, validation, and linearity reagents must be compatible with Cobas 6800.

The Microbiology/Molecular supervisor/designee will be the individuals designated to order against this contract.

All reagents will be delivered to the dock area of :

VA Pittsburgh Healthcare System University Drive Pittsburgh, PA 15240 Materials will be shipped within 3 business days of ordering.

Monthly updates of materials shipped from the vendor will be sent via email to the Microbiology/Molecular contact at VA Pittsburgh.

Printed MSDS/SDS will be available upon request.

Continuing educational opportunities will be offered by the contractor.

Shipping, handling, and freight charges will be the responsibility of the contractor.

Technical Requirements:

Reagents must be compatible with Cobas 6800 and Cobas 6800 proprietary software.

Storage of patient results on the analyzer

3.2 Service Requirements

Services performed shall be of a non-personal nature. VA organizations will not provide supervision of contractor personnel. Contractor personnel shall at no time allow an employer-employee relationship to develop with VA organizations or their staff. VA organizations will refrain from any activities that create the appearance of such a relationship. Contractors shall not perform inherently governmental functions including decision-making, supervision of Government employees, supervision of other contractors on other contracts, and activities that create the appearance of performing such functions. Service requirements are as follows:

Technical service shall be provided by telephone 8am-5pm EST (Mon-Fri) Field service shall be provided within 24 hours of notification. Hours of service shall be 8am- 5pm EST (Mon-Fri) Analyzers shall be covered under warranty during the entire contracted period to include service, repair and/or replacement.

3.3 Service Groups

The proposed contractor shall provide services, labor categories, and solutions necessary to fulfill the scope of service groups one (1) and two (2) and at least one (1) other group. The entire contractor team shall collectively provide services, labor categories, and solutions necessary to fulfill the scope of all service groups.

3.3.1 Group 1 - Program and Project Management and Integration

The contractor shall provide services facilitation as they relate to program and project management, strategic planning, and performance measurement in a healthcare environment, as outlined below. Critical to the success of this work is an integrated approach, encompassing all lines of effort.

3.3.1.1 Program and Project Management

The contractor will provide support to assist the Government in implementing disciplined, comprehensive, and flexible program and project management processes, including monitoring of project metrics, rigorous risk management, and prompt reporting on Government-approved cost, schedule, performance, and risk baseline.

When needed the approach must incorporate large integrated (to include governmental) healthcare project management best practices. Program and project management must integrate all functions required for a success.

3.3.1.2 Business Requirements Development

The contractor shall support the development of healthcare business requirements to support strategic implementation of new technology solutions that improve business efficiency while meeting programmatic goals. Tasks may include gathering customer input, identifying measures, assumptions, or dependencies, integrating process into larger systems requirements, defining non-universal terms, and interfacing with information technology staff to communicate requirements.

Strategic Planning

The contractor shall provide support of healthcare strategic planning, including development of strategic goals, objectives, strategies, performance measures, targets, improved programmatic outcomes, succession plans, and linkages to programming, budgeting, and evaluation. 3.3.1.4 Performance Measurement.

The contractor shall provide support of strategic performance measurement development based upon healthcare industry standards, including improved linkage between VA-wide strategic goals and VA programmatic outcomes; and implementation of the Government Performance and Results Act (GPRA) Modernization Act (GPRAMA).

3.3.1.5 Program Evaluation

The contractor will employ a systematic method for collecting, analyzing, and leveraging information to evaluate healthcare projects, policies and programs for effectiveness and efficiency.

3.3.1.6 Acquisitions Support

The Contractor shall provide acquisition subject matter expert services to support development of acquisition packages that address portfolio, program, and project-level product and service requirements. See paragraph 8.1 for potential OCI restrictions related to this task area.

Tasks may include the development of a Strategic Acquisition Plan that identifies required acquisitions, corresponding budgets, and gaps, risks, and issues that may impact success and support to the Government in the development of acquisition packages to address program goals.

3.3.2 Group 2 – Improvement and Change Management

The contractor shall provide services and facilitation as they relate to large integrated healthcare business process reengineering, business process improvement, business process management, and change management and transition, as outlined below.

3.3.2.1 Business Process Reengineering, Improvement and Management

The contractor shall conduct studies in support of healthcare system redesign and business process reengineering, improvement, and management. The contractor shall develop implementation plan and support the process of implementing and sustaining improvements.

The contractor shall use a healthcare system engineering approach to conduct organizational studies that specifically assess and analyze current organizational states and management systems and perform gap analyses of differences between current and targeted states, including findings and recommendations. Contractor shall provide all business architecture deliverables in accordance with VHA Standards as mandated by VHA Business Architecture.

3.3.2.2 Change Management and Transition

The contractor shall support all activities associated with organizational change, including but not limited to, transition management, implementation of major initiatives, communications associated with major initiatives, risk assessment, and organizational transformation and culture change, to include assessment of organizational health.

3.3.2.3 Quality Management

The contractor shall provide support of quality management systems, tools, and techniques to help organizations transform, including, but not limited to, CMMI, Lean Six Sigma (LSS), ISO 9000/9001, and the Malcolm Baldrige Quality Award criteria.

Group 3 – Data and Analyses

The contractor shall provide services as they relate to studies and analyses, information and records management, and surveys and research, as outlined below.

3.3.3.1 Studies and analyses

The contractor shall provide healthcare studies as they relate to staffing, evaluation, human resources, organization, leadership, efficiency, effectiveness, gap analyses, organization development, timeliness and quality of care, and emergency preparedness. The contractor shall also conduct surveys, focus groups, conjoint analyses, and other VHA accepted techniques for data collection in support of transformation initiatives. Among myriad potential healthcare related study subjects, tasks may include studies of advanced healthcare methodologies and technology (to include the use of Artificial Intelligence in healthcare) and the study and utilization of emerging (disruptive) models in healthcare.

The contractor shall conduct organizational studies and evaluations, design systems and procedures, conduct work simplification and measurement studies, and prepare operations and procedures manuals to assist management in operating more efficiently and effectively.

3.3.3.2 Information and Records Management

The contractor shall evaluate and recommend solutions to compile, evaluate, analyze, control, secure, and disseminate timely, relevant, objective, and accurate data and information to VHA and VHA stakeholders, including, but not limited to, web-based designs, data governance, operational systems, document storage, applications, models, and assessment of existing legacy systems. These services may include the digitization of hard records to electronic media, disposition of records, and storage of records in accordance with specific regulations.

Approaches shall include healthcare industry standards.

3.3.3.3 Data Governance

The contractor shall support in the management of the availability, usability, integrity, and security of the VHA’s healthcare data. Services may include consultations, and process improvements.

3.3.4 Group 4 – Training

The contractor shall design, conduct, and evaluate training in support of projects and programs.

Training tasks may require development of web-based and in-person training integrated with work performed across all other service groups and may require healthcare expertise.

3.3.4.1 Training Development

The contractor will create training in various mediums for delivery to desired audience.

3.3.4.2 Training Delivery

The contractor will deliver training in various mediums to include face to face, online, or hybrid formats.

3.3.5. Group 5 – Strategic Communications and Implementation

The contractor shall provide services as they relate to outreach, promotional materials, and advertising for internal and external customers. Communications support will be integrated with work performed across all other service groups and may require healthcare expertise.

3.3.5.1 Strategic

The contractor shall provide support to assist in defining, implementing, and executing a communications strategy that establishes consistent messaging, public relations management, and structured internal and external communication practices. Plans will be related to VHA initiatives, priorities, healthcare operations and services and may include inter-agency collaboration, the integration of multiple programs, and national level campaigns. Additionally, the contractor shall assess the return on investment (ROI), effectiveness, and performance of the communication or marketing plan using industry standard best practices and comprehensive metrics/analytics tools and techniques. The communications strategy should closely align with the overall change management approach (Service Group 2), reflected in its target audiences, modalities, and timing of internal and external communications.

3.3.5.2 Executive Support

Contractor shall provide planning, design, organization and management of healthcare executive correspondence and documentation. Tasks may include the development and preparation of presentation materials and business correspondence for Government approval, to include but not limited to PowerPoint, speeches, and virtual presentations, brochures, posters, templates, Web graphics, fact sheets, talking points, e-Mail blast content and other materials. Tasks may also include the tracking and reviewing of the status and progress of actions related to the correspondence to ensure the timeliness of responses.

3.3.5.3 Advertising Services

The contractor shall develop materials to promote the public and private awareness of the VHA’s mission, goals, initiatives, and objectives to ensure complete understanding of the complex and technical aspects and social issues of the VHA. Additionally, to disseminate information to industry, consumer advocacy groups, and Veteran Service Organizations and engage in recruitment campaigns.

Services may include the following healthcare related components: advertising objective determination, message decision / creation, media selection, outdoor marketing and media services, broadcast media (radio, TV, and public service announcements), direct mail services, web-based media services, media planning, media placement services, advertising evaluation, and related activities to advertising services.

3.3.5.4 Media Buying

The contractor shall assist in the procurement of healthcare related advertising and outreach activities that can be in the form of television stations time, periodicals ads, internet advertisement, radio, social media, billboards, public transportation, etc. for the VHA. The contractor shall provide support in negotiating media in accordance with research and analysis and purchasing paid advertising to impact targeted healthcare markets and audiences;

generating excitement and awareness of VHA benefits, healthcare, and services.

3.3.5.5 Public Relations Services/Outreach

The contractor shall assist in the healthcare related strategic communication plan that builds beneficial relationships between the VHA, the public, and other entities. The Contractor shall provide support to assist in developing plans for various Department-wide outreach campaigns and recommending the most effective way of communicating a message in print, electronic format, or both, including social media and web-based outreach.

Other related services may fall under the following categories: executing healthcare related media programs, conducting press conferences, scheduling broadcast and/or print interviews, public relations, and crisis communications media training, such as, training of agency healthcare personnel to deal with media and media responses, media alerts and press clipping services related activities to public relations services.

3.3.5.6 Conference, Events, and Planning Services

The contractor shall develop and support the VHA in preparation of healthcare related conferences, seminars, and events planning services by providing materials that can be presented and/or provided to participants of these events. Services may include the following components for an event and/or booth: project management, coordination and implementation of third party participation, collection management of third party payment for participation, liaison support with venue, audiovisual and information technology support, topic and speaker identification, site location research, reservation of facilities, on-site meeting and registration support, editorial services, automation and telecommunications support, design and editing productions; and mailing and other communication with attendees including pre/post meeting mailings/travel support and computer database creation.

3.3.5.7 Healthcare Related Promotional Materials

The contractor shall develop healthcare related promotional materials in multiple medium. This type of medium can include pamphlets, posters, brochures, etc. Services may include the following components: developing conceptual design and layouts, providing copywriting and technical writing services, creating sketches, drawings, publication designs, and typographic layouts; and furnishing custom or stock artwork (including electronic artwork).

3.3.5.8 Video/Film Production

The contractor shall develop healthcare related video and/or film materials in multiple mediums to include digital media for the use by the VHA. Services may include final editing, copyrights and editing to fit various formats, i.e. High-Definition, streaming, Moving Picture Experts Group (MPEG), etc.

3.3.5.9 Graphics Design

The contractor shall support in the development of healthcare related visual communication for internal and external facing using photography, illustration, visual arts, page layout, etc.

Services may include logo design, periodical design, web design, and signage.

3.3.6 Group 6 – Supply Chain

The contractor shall provide services as they relate to the discipline of healthcare supply chain management concepts to include process improvement, cold chain management, delivery and storage of goods, and cost benefit analytical studies.

3.3.6.1 Supply Chain and Healthcare Logistics Analysis

The contractor shall provide support in the analysis of healthcare supply chain efficiency and improvement measures. The services include all phases of planning, acquisition, and management of logistics systems. These services may include planning, acquisition, design, development, testing, production, fielding, management, operation, maintenance, sustainment, improvement, modification, and disposal.

3.3.6.2 Supply Chain Management

The contractor shall provide support in the management and analysis of the system of the VA, personnel, and resources involved in the moving and procurement of healthcare supplies from the supplier to the VA. These activities may include analysis of the transformation of raw materials to the finished product, the coordination and collaboration with channel partners, and responsibility for linking business functions and processes.

3.3.6.3 Supply Chain Planning

The contractor shall provide support in the process of predicting future healthcare requirements to balance supply and demand of the VA. Services may include the analysis of supply stock, future forecast, etc.

3.3.6.4 Inventory Management and Operation

The contractor shall provide support in the practice of overseeing and controlling the systemic ordering, storage, and use of resources in stock of healthcare supplies and inventory for the VA.

These activities may include the analysis of mitigating risks to increase value from the vendors used in the procurement process, cost control processes, and analysis of quality measurements of consumables, expendables, and supplies.

3.3.6.5 Supply Chain Optimization

The contractor shall provide support in the analytical study of identifying efficiencies or lack of efficiencies in the healthcare supply chain of the VA.