S02. 36C25625Q0522.pdf

Combined Synopsis/Solicitation Notice

*= Required Field Combined Synopsis/Solicitation Notice

SUBJECT* Pharmacy United States Pharmacopeia (USP) Sampling Services Fayetteville VA Medical Center

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 77056-5643

SOLICITATION NUMBER* 36C25625Q0522

RESPONSE DATE/TIME/ZONE 03-13-2025 5:00 PM CENTRAL TIME, CHICAGO,

USA

ARCHIVE 60 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N/A

SET-ASIDE SDVOSB

PRODUCT SERVICE CODE* F107

NAICS CODE* 541380

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

Network Contracting Office 16 5075 Westheimer Road, Suite 750 Houston, TX 77056-5643

POINT OF CONTACT*

Contract Specialist Caleb Parker caleb.parker@va.gov

PLACE OF PERFORMANCE

ADDRESS Fayetteville VA Medical Center

1100 North College Avenue Fayetteville, AR 72703-1944

DESCRIPTION

This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2025-03, dated 01/17/2025.

This acquisition is 100% set aside for Service-Disabled Veteran Owned Small Businesses.

Offerors must be VetCert certified at time of quote submission.

The associated North American Industrial Classification System (NAICS) code for this procurement is 541380, with a small business size standard of $19.0 million. The Product/Service Code is F107.

The Department of Veterans Affairs (VA), Network Contracting Office 16 (NCO 16) located at the Galleria Financial Center, 5075 Westheimer Road, Suite 750, Houston, TX 77056 is seeking to procure Pharmacy USP Sampling Services in accordance with the Statement of Work

(SOW).

The Pharmacy USP Sampling Services listed below has been identified as meeting the minimum needs of the Government. All interested vendors shall provide quotations for the following schedule:

Base Period: July 14, 2025 through September 30, 2025 Line Item

Description Quantity Unit of

Measure Unit Price

Discount % or $ (If applicable)

Extended Price

Pharmacy USP Sampling Service in accordance with the Statement of Work.

2 MO

Base Period Total:

Option Period 1: October 1, 2025 through September 30, 2026

Line Item

Description Quantity Unit of

Measure Unit Price

Discount % or $ (If applicable)

Extended Price

Pharmacy USP Sampling Service in accordance with the Statement of Work.

12 MO

Option Period 1 Total:

Option Period 2: October 1, 2026 through September 30, 2027 Line Item

Description Quantity Unit of

Measure Unit Price

Discount % or $ (If applicable)

Extended Price

Pharmacy USP Sampling Service in accordance with the Statement of Work.

Option Period 2 Total:

Option Period 3: October 1, 2027 through September 30, 2028

Item

Description Quantity Unit of

Measure Unit Price

Discount % or $ (If applicable)

Extended Price

Pharmacy USP Sampling Service in accordance with the Statement of Work.

Option Period 3 Total:

Option Period 4: October 1, 2028 through September 30, 2029

Item

Description Quantity Unit of

Measure Unit Price

Discount % or $ (If applicable)

Extended Price

Pharmacy USP Sampling Service in accordance with the Statement of Work.

Option Period 4 Total:

Option Period 5: October 1, 2029 through July 13, 2030

Item

Description Quantity Unit of

Measure Unit Price

Discount % or $ (If applicable)

Extended Price

Pharmacy USP Sampling Service in accordance with the Statement of Work.

9 MO

Option Period 5 Total:

Grand Total (Including Option Periods):

Wage Determination:

The following wage determination applies:

Wage Determination No. 2015-5109 Revision No. 26 dated 12-23-2024

Invoicing:

In accordance with FAR Clause 52.212-4 (g)(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR Part 1315. All invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

FSC e-Invoice Payment at http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 or va.registration@tungsten-network.com

The following solicitation provisions apply to this acquisition:

52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these addresses:

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

FAR Title Date

52.204-7 SYSTEM FOR AWARD MANAGEMENT Oct 2018

52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING Aug 2020

52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES

Sep 2023

52.212-2 EVALUATION – COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES

Nov 2021

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS-

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, “Offerors Representations and Certifications–Commercial Products and Commercial Services.” If paragraph (j) of the provision is applicable, a written submission is required.

May 2024

Addendum to 52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES

The following provisions are incorporated into 52.212-1 as an addendum to this combined synopsis/solicitation:

Instructions for the Preparation of Quotes:

Offeror shall provide the following documentation for the quote to be considered:

1. A completed Price/Cost Schedule (to include pricing for all line items), located on pages 2 and 3 of this document. Insert legible proposed unit and total all-inclusive pricing using the table for each contract line item. No other format for the submission of the Price/Cost Schedule shall be accepted.

2. A completed Contractor Contract Administration Data Form, located on page 18 of this document. Provide POC name, complete address, phone number, email, SAM UEI Number, and Tax ID.

3. A completed Attachment D.2 Past Performance References Form. Provide past performance information as outlined in the evaluation factors below.

4. Complete the required clause fill-ins and return a signed copy of 852.219-75 VA Notice of Limitations on Subcontracting - Certificate of Compliance for Services and Construction on pages 12 - 14.

5. For the purpose of evaluation of technical capability, the Contractor shall provide detailed information within the quote to demonstrate that the offered services meet or exceed the minimum requirements found in the SOW. The Contractor may include any other information that is deemed necessary. The Government will evaluate only that information that is provided with the quotes; any vendor that fails to provide sufficient technical detail regarding the offered services runs the risk of having the quote rejected.

(End of Addendum to 52.212-1)

Addendum to 52.212-2 EVALUATION – COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES

In accordance with FAR 13.106-2(b)(3), the Government will evaluate quotes based on the comparative evaluation process, by comparing one quote with another in a uniform and fair manner to determine which quote provides the best value to the Government. The Government reserves the right to consider a quotation other than the lowest price that provides additional benefit(s). Quotations may exceed minimum requirements of the solicitation. The Government reserves the right to select a quotation that provides benefit to the Government that exceeds the minimum requirements of the solicitation but is not required to do so. Each response must meet the minimum requirements of the solicitation.

The following factors shall be used to evaluate offers: Technical, Past Performance, and Price.

The Government will award a single Firm-Fixed Price contract to the responsible vendor whose quotation conforming to the solicitation will be most advantageous to the Government, price and other factors considered.

Quotes will be evaluated to determine compliance with the requirements of this combined synopsis/solicitation as follows:

1. Factor 1 – Technical The quotation will be evaluated to the extent to which it can meet and/or exceed the Government’s requirements as outlined in the combined synopsis/solicitation and based on the information requested in the instructions to quoters section of the solicitation to be eligible for award.

2. Factor 2 – Past Performance Past performance information is one indicator on the ability to perform the contract successfully. The Government shall assess how well the offeror provided service to other customers in the past. Generally, the Government shall rely upon the information provided by the offeror. The Government shall consider this information as well as information obtained from any other sources, when evaluating the offeror’s past performance. Past performance will be rated as acceptable, unacceptable or neutral.

Determination Definition Acceptable The offeror meets or exceeds the (acceptability) standard.

Unacceptable The offeror fails to meet the (acceptability) standard.

Neutral The offeror had no past performance.

a. The Offeror shall provide a minimum of three (3) past performance references of current contracts or contracts within the past five years of similar size, scope and/or complexity. Reference may include Federal, State, and local Government as well as private customers and shall include the following information:

i. Name and Address of the Contracting Activity (Medical Center, Company, etc).

ii. Name and Telephone Number of Point of Contact (Contracting Officer, Contracting Officer Representative, or Manager) who would have first-hand knowledge on contract performance and/or satisfaction.

iii. Contract Number and Dates of Contract Performance.

iv. List of Subcontracts (if applicable).

b. Offerors shall submit past performance references using attachment D.2. The Government may use other sources including but not limited to Contractor Performance Assessment Reporting System (CPARS) and System for Award Management (SAM.gov) Responsibility/Qualification Records (formerly FAPIIS) for relevant past performance information. Offerors with no relevant performance history will receive a neutral rating.

3. Factor 3 – Price Offerors' price quotes will be evaluated to determine the price is fair and reasonable in accordance with FAR 13.106-3 (a). In addition, the offeror’s price will be compared against competing quotes and the Independent Government Cost Estimate. Quotations should include a proposed unit price for each line item, as well as the extended amount (unit price multiplied by quantity).

Offerors that are determined unacceptable based on Past Performance or Technical Capability cannot be selected regardless of price. For offers that are considered essentially the same in Past Performance and Technical Capability, Price will be the determining factor to determine the offer that is most advantageous to the Government.

4. The Government intends to make its award decision with initial quote submitted by the contractor. However, the Government reserves the right to conduct communications with contractors if it is in its best interest of the Government to do so. Therefore, each offeror is encouraged to provide the Government with all of the information necessary to evaluate its initial quote under the evaluation factors stated above.

Offerors that fail to submit all the information necessary to evaluate their quote with their initial quote submission or do not conform with the solicitation requirements bears the risk that their quote may not be eligible for award.

5. For the purposes of the award of this contract, the Government intends to evaluate the option to extend services under FAR 52.217-8 as follows: The evaluation will consider the possibility that the option can be exercised at any time, and can be exercised in increments of one to six months, but for no more than a total of six months during the life of the contract. The evaluation will assume that the prices for any option exercised under FAR 52.217-8 will be at the same rates as those in effect under the contract at the time the option is exercised. The evaluation will therefore assume that the addition of the price or prices of any possible extension or extensions under FAR 52.217-8 to the total price for the basic requirement and the total price for the priced options has the same effect on the total price of all quotes relative to each other, and will not affect the ranking of quotes based on price, unless, after reviewing the quotes, the Government determines that there is a basis for finding otherwise. This evaluation will not obligate the Government to exercise any option under FAR 52.217-8.

6. The award will be made to the response most advantageous to the Government.

Responses should contain your best terms and conditions. Quotes shall be received on or before the date and time specified on page 1 of this document. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Contractor's quote submissions that do not comply/conform with the solicitation requirements and or determined not capable to meet the SOW requirements all factors considered may not be eligible for award.

(End of Addendum to 52.212-2)

The following contract clauses apply to this acquisition:

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

FAR Title Date

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE Oct 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

Aug 2020

52.212-4 CONTRACT TERMS AND CONDITIONS-COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

Nov 2023

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS-

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

May 2024

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

FAR 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days.

Note: The specified rates under this clause will be those rates in effect under the contract each time an option is exercised under this clause.

(End of Clause)

FAR 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

(End of Clause)

VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

The Contracting Officer reserves the right to designate representatives to act for him/her in furnishing technical guidance and advice or generally monitor the work to be performed under this contract. Such designation will be in writing and will define the scope and limitation of the designee’s authority. A copy of the appointment letter shall be furnished to the Contractor.

(End of Clause)

VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

The Contractor shall not make reference in its commercial advertising to Department of Veterans Affairs contracts in a manner that states or implies the Department of Veterans Affairs approves or endorses the Contractor's products or services or considers the Contractor's products or services superior to other products or services.

(End of Clause)

852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR VERIFIED SERVICE-DISABLED

VETERAN-OWNED SMALL BUSINESSES (NOV 2022)

(a) Definition. for the Department of Veterans Affairs, “Service-disabled Veteran-owned small business concern or SDVOSB”:

(1) Means a small business concern -

(i) Not less than 51 percent of which is owned by one or more service-disabled Veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled Veterans or eligible surviving spouses (see VAAR802.101, Surviving Spouse definition);

(ii) The management and daily business operations of which are controlled by one or more service-disabled Veterans (or eligible surviving spouses) or, in the case of a service-disabled Veteran with permanent and severe disability, the spouse or permanent caregiver of such Veteran;

(iii) The business meets Federal small business size standards for the applicable North American Industry Classification System (NAICS) code identified in the solicitation document;

(iv) The business has been verified for ownership and control pursuant to 38 CFR part 74 and is listed in VA's Vendor Information Pages (VIP) database at https://www.vetbiz.va.gov/vip/; and

(v) The business will comply with VAAR subpart 819.70 and Small Business Administration (SBA) regulations regarding small business size and government contracting programs at 13 CFR parts 121 and 125, provided that any reference therein to a service-disabled veteran-owned small business concern or SDVO SBC, is to be construed to apply to a VA verified and VIP-listed SDVOSB, unless otherwise stated in this clause.

(2) The term “Service-disabled Veteran” means a Veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

(3) The term “small business concern” has the meaning given that term under section 3 of the Small Business Act (15 U.S.C. 632).

(4) The term “small business concern owned and controlled by Veterans with service-connected disabilities” has the meaning given the term “small business concern owned and controlled by service-disabled veterans” under section 3(q)(2) of the Small Business Act (15 U.S.C.

632(q)(2)), except that for a VA contract the firm must be listed in the VIP database (see paragraph (a)(1)(iv) of this clause).

(b) General.

(1) Offers are solicited only from VIP-listed SDVOSBs. Offers received from entities that are not VIP-listed SDVOSBs at the time of offer shall not be considered.

(2) Any award resulting from this solicitation shall be made to a VIP-listed SDVOSB who is eligible at the time of submission of offer(s) and at the time of award.

(3) The requirements in this clause apply to any contract, order or subcontract where the firm receives a benefit or preference from its designation as an SDVOSB, including set-asides, sole source awards, and evaluation preferences.

(c) Representation. Pursuant to 38 U.S.C. 8127(e), only VIP-listed SDVOSBs are considered eligible to receive award of a resulting contract. By submitting an offer, the prospective contractor represents that it is an eligible SDVOSB as defined in this clause, 38 CFR part 74, and VAAR subpart 819.70.

(d) Agreement. When awarded a contract action, including orders under multiple-award contracts, an SDVOSB agrees that in the performance of the contract, the SDVOSB shall comply with requirements in VAAR subpart 819.70 and SBA regulations on small business size and government contracting programs at 13 CFR part 121 and part 125, including the non-manufacturer rule and limitations on subcontracting requirements in 13 CFR 121.406(b) and 13 CFR 125.6. Unless otherwise stated in this clause, a requirement in 13 CFR parts 121 and 125 that applies to an SDVO SBC, is to be construed to also apply to a VIP-listed SDVOSB. For the purpose of limitations on subcontracting, only VIP-listed SDVOSBs (including independent contractors) shall be considered eligible and/or “similarly situated” (i.e., a firm that has the same small business program status as the prime contractor). An otherwise eligible firm further agrees to comply with the required certification requirements in this solicitation (see 852.219-75 or 852.219-76 as applicable). These requirements are summarized as follows:

(1) Services. In the case of a contract for services (except construction), the SDVOSB prime contractor will not pay more than 50% of the amount paid by the government to the prime for contract performance to firms that are not VIP-listed SDVOSBs (excluding direct costs to the extent they are not the principal purpose of the acquisition and the SDVOSB/VOSB does not provide the service, such as airline travel, cloud computing services, or mass media purchases).

When a contract includes both services and supplies, the 50 percent limitation shall apply only to the service portion of the contract

(2) Supplies/products.

(i) In the case of a contract for supplies or products (other than from a non-manufacturer of such supplies), the SDVOSB prime contractor will not pay more than 50% of the amount paid by the government to the prime for contract performance, excluding the cost of materials, to firms that are not VIP-listed SDVOSBs. When a contract includes both supply and services, the 50 percent limitation shall apply only to the supply portion of the contract.

(ii) In the case of a contract for supplies from a non-manufacturer, the SDVOSB prime contractor will supply the product of a domestic small business manufacturer or processor, unless a waiver as described in 13 CFR 121.406(b)(5) has been granted. Refer to 13 CRF 125.6(a)(2)(ii) for guidance pertaining to multiple item procurements.

(3) General construction. In the case of a contract for general construction, the SDVOSB prime contractor will not pay more than 85% of the amount paid by the government to the prime for contract performance, excluding the cost of materials, to firms that are not VIP-listed SDVOSBs.

(4) Special trade construction contractors. In the case of a contract for special trade contractors, no more than 75% of the amount paid by the government to the prime for contract performance, excluding the cost of materials, may be paid to firms that are not VIP-listed SDVOSBs.

(5) Subcontracting. An SDVOSB must meet the NAICS size standard assigned by the prime contractor and be listed in VIP to count as similarly situated. Any work that a first tier VIP-listed SDVOSB subcontractor further subcontracts will count towards the percent of subcontract amount that cannot be exceeded. For supply or construction contracts, the cost of materials is excluded and not considered to be subcontracted. When a contract includes both services and supplies, the 50 percent limitation shall apply only to the portion of the contract with the preponderance of the expenditure upon which the assigned NAICS is based. For information and more specific requirements, refer to 13 CFR 125.6.

(e) Required limitations on subcontracting compliance measurement period. An SDVOSB shall comply with the limitations on subcontracting as follows:

[Contracting Officer check as appropriate.]

X By the end of the base term of the contract or order, and then by the end of each subsequent option period; or

__By the end of the performance period for each order issued under the contract.

(f) Joint ventures. A joint venture may be considered eligible as an SDVOSB if the joint venture is listed in VIP and complies with the requirements in 13 CFR 125.18(b), provided that any requirement therein that applies to an SDVO SBC is to be construed to apply to a VIP-listed SDVOSB. A joint venture agrees that, in the performance of the contract, the applicable percentage specified in paragraph (d) of this clause will be performed by the aggregate of the joint venture participants.

(g) Precedence. The VA Veterans First Contracting Program, as defined in VAAR 802.101, subpart 819.70, and this clause, takes precedence over any inconsistencies between the requirements of the SBA Program for SDVO SBCs, and the VA Veterans First Contracting Program.

(h) Misrepresentation. Pursuant to 38 U.S.C. 8127(g), any business concern, including all its principals, that is determined by VA to have willfully and intentionally misrepresented a company's SDVOSB status is subject to debarment from contracting with the Department for a period of not less than five years (see VAAR 809.406-2 Causes for Debarment).

(End of clause)

852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—CERTIFICATE OF

COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023) (DEVIATION)

(a) Pursuant to 38 U.S.C. 8127(l)(2), the offeror certifies that—

(1) If awarded a contract (see FAR 2.101 definition), it will comply with the limitations on subcontracting requirement as provided in the solicitation and the resultant contract, as follows:

[Contracting Officer check the appropriate box below based on the predominant NAICS code assigned to the instant acquisition as set forth in FAR 19.102.]

(i) [X] Services. In the case of a contract for services (except construction), the contractor will not pay more than 50% of the amount paid by the government to it to firms that are not certified SDVOSBs listed in the SBA certification database as set forth in 852.219-73 or certified VOSBs listed in the SBA certification database as set forth in 852.219-74. Any work that a similarly situated certified SDVOSB/VOSB subcontractor further subcontracts will count towards the 50% subcontract amount that cannot be exceeded. Other direct costs may be excluded to the extent they are not the principal purpose of the acquisition and small business concerns do not provide the service as set forth in 13 CFR 125.6.

(ii) [ ] General construction. In the case of a contract for general construction, the contractor will not pay more than 85% of the amount paid by the government to it to firms that are not certified SDVOSBs listed in the SBA certification database as set forth in 852.219-73 or certified VOSBs listed in the SBA certification database as set forth in 852.219-74. Any work that a similarly situated certified SDBOSB/VOSB subcontractor further subcontracts will count towards the 85% subcontract amount that cannot be exceeded. Cost of materials are excluded and not considered to be subcontracted.

(iii) [ ] Special trade construction contractors. In the case of a contract for special trade contractors, the contractor will not pay more than 75% of the amount paid by the government to it to firms that are not certified SDVOSBs listed in the SBA certification database as set forth in 852.219-73 or certified VOSBs listed in the SBA certification database as set forth in 852.219-

74. Any work that a similarly situated certified SDBOSB/VOSB subcontractor further subcontracts will count towards the 75% subcontract amount that cannot be exceeded. Cost of materials are excluded and not considered to be subcontracted.

(2)The offeror acknowledges that this certification concerns a matter within the jurisdiction of an Agency of the United States. The offeror further acknowledges that this certification is subject to Title 18, United States Code, Section 1001, and, as such, a false, fictitious, or fraudulent certification may render the offeror subject to criminal, civil, or administrative penalties, including prosecution.

(3) If VA determines that an SDVOSB/VOSB awarded a contract pursuant to 38 U.S.C. 8127 did not act in good faith, such SDVOSB/VOSB shall be subject to any or all of the following:

(i) Referral to the VA Suspension and Debarment Committee;

(ii) A fine under section 16(g)(1) of the Small Business Act (15 U.S.C. 645(g)(1)); and

(iii) Prosecution for violating 18 U.S.C. 1001.

(b)The offeror represents and understands that by submission of its offer and award of a contract it may be required to provide copies of documents or records to VA that VA may review to determine whether the offeror complied with the limitations on subcontracting requirement specified in the contract. Contracting officers may, at their discretion, require the contractor to demonstrate its compliance with the limitations on subcontracting at any time during performance and upon completion of a contract if the information regarding such compliance is not already available to the contracting officer. Evidence of compliance includes, but is not limited to, invoices, copies of subcontracts, or a list of the value of tasks performed.

(c)The offeror further agrees to cooperate fully and make available any documents or records as may be required to enable VA to determine compliance with the limitations on subcontracting requirement. The offeror understands that failure to provide documents as requested by VA may result in remedial action as the Government deems appropriate.

(d)Offeror completed certification/fill-in required. The formal certification must be completed, signed and returned with the offeror’s bid, quotation, or proposal. The Government will not consider offers for award from offerors that do not provide the certification, and all such responses will be deemed ineligible for evaluation and award.

Certification:

I hereby certify that if awarded the contract, [insert name of offeror] will comply with the limitations on subcontracting specified in this clause and in the resultant contract. I further certify that I am authorized to execute this certification on behalf of [insert name of offeror].

Printed Name of Signee: ______________________________

Printed Title of Signee: ______________________________

Signature: ______________________________

Date: ______________________________

Company Name and Address: ______________________________

(End of clause)

VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001;

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests;

(4) Invoice payment has the meaning given in FAR 32.001; and

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System at the current website address provided in the contract.

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National Standards Institute (ANSI).

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances in this paragraph (e), the Contracting Officer directs that payment requests be made by mail, the Contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office.

Submission of payment requests by mail may be required for—

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

(End of Clause)

VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

The Contracting Officer reserves the right to designate an Administrative Contracting Officer (ACO) for the purpose of performing certain tasks/duties in the administration of the contract.

Such designation will be in writing through an ACO Letter of Delegation and will identify the responsibilities and limitations of the ACO. A copy of the ACO Letter of Delegation will be furnished to the Contractor.

(End of Clause)

VAAR 852.273-75 SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION

TECHNOLOGY RESOURCES (interim - OCT 2008)

The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

(End of Clause)

(End of Addendum to 52.212-4)

The following subparagraphs of FAR 52.212-5 are applicable:

FAR Title Date

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS Nov 2023

52.204-27 PROHIBITION ON A BYTEDANCE COVERED APPLICATION Jun 2023

52.209-6 PROTECTING THE GOVERNMENT’S INTEREST WHEN

SUBCONTRACTING WITH CONTRACTORS DEBARRED,

SUSPENDED, OR PROPOSED FOR DEBARMENT

Nov 2021

52.219-27 NOTICE OF SET-ASIDE FOR, OR SOLE SOURCE TO, SERVICE-

DISABLED VETERAN-OWNED SMALL BUSINESS (SDVOSB)

CONCERNS ELIGIBLE UNDER THE SDVOSB PROGRAM

Feb 2024

52.219-28 POST-AWARD SMALL BUSINESS PROGRAM REREPRESENTATION Feb 2024

52.222-3 CONVICT LABOR Jun 2003

52.222-21 PROHIBITION OF SEGREGATED FACILITIES Apr 2015

52.222-26 EQUAL OPPORTUNITY Sep 2016

52.222-36 EQUAL OPPORTUNITY FOR WORKERS WITH DISABILITIES Jun 2020

52.222-50 COMBATING TRAFFICKING IN PERSONS Nov 2021

52.226-8 ENCOURAGING CONTRACTOR POLICIES TO BAN TEXT

MESSAGING WHILE DRIVING

May 2024

52.232-33 PAYMENT BY ELECTRONIC FUNDS TRANSFER—SYSTEM FOR

AWARD MANAGEMENT

Oct 2018

To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Quoters shall list exception(s) and rationale for the exception(s), if any.

Quote Content and Format: Offerors should review the combined synopsis/solicitation in its entirety. Offerors are responsible for ensuring that their quote fully complies with submission requirements outlined in the combined synopsis/solicitation.

Failure to explain the offerors’ ability to meet all requirements will result in the proposing contractor to be removed from consideration for award.

Clarity and completeness of quotes are of the utmost importance. Therefore, quotes must be written in a practical, clear, and concise manner.

System for Award Management (SAM): Offerors are required to be registered in SAM at the time an offer or quotation is submitted per FAR Subpart 4.1102 (a). Keep in mind that the SAM registration process can take time to complete. Offerors are encouraged to go to the SAM database at www.sam.gov and start the registration process as soon as possible. If you are already registered in SAM, remember that your SAM registration must be renewed at least annually – and renewed whenever any part of your registration needs to be updated.

Technical Questions: All questions must be received in writing on or before March 06, 2025 at 2:00 PM CST. No phone inquiries will be accepted. All questions, comments, and requests for information regarding this acquisition shall be sent by email, cite the solicitation number in the subject line. The Government reserves the discretion not to respond to any inquiries submitted after March 06, 2025 at 2:00 PM CST. All inquiries regarding this combined synopsis-solicitation must be sent to the Contract Specialist email at caleb.parker@va.gov. All responses to questions will be incorporated into a written amendment.

Submission of Quotes: All quotes shall be sent electronically via email to Caleb Parker at caleb.parker@va.gov. Quotations shall be received no later than 5:00 PM CST, Thursday, March 13, 2025.

(THE REMAINDER OF THIS PAGE IS INTENTIONALLY LEFT BLANK)

CONTRACT ADMINISTRATION DATA

Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

Phone: ______________________

Email: _______________________

SAM UEI Number: ________________

TAX ID: ______________________

b. GOVERNMENT:

Marcos Madrazo-Jones, Contracting Officer Department of Veterans Affairs Network Contracting Office 16 5075 Westheimer Road, Suite 750 Houston TX 77056-5643 Email: marcos.madrazo-jones@va.gov

Caleb Parker, Contract Specialist Department of Veterans Affairs Network Contracting Office 16 5075 Westheimer Road, Suite 750 Houston TX 77056-5643 Email: caleb.parker@va.gov

Statement of Work (SOW)

1. GENERAL REQUIREMENTS:

An ISO/TEC 17025 accredited laboratory under the Environmental Microbiology Lab Accreditation Program (EMLAP) will process (incubate, analyze, record and report results) microbiological surface samples, Gloved Fingertip and Thumb samples (GFS) and Media Fill Testing (MFT) samples obtained and submitted by Veterans Healthcare System of the Ozarks (VHSO). Samples will be processed according to the most current version of CAG- 009-2011 (or its successor) and results will be compared to recommendations provided in

USP <797>.

All sampling supplies, plates and media fill will be provided by the laboratory pursuant to this contract. Certificate of analysis from the manufacturer will be provided for each lot of growth media to verify that the media meet the expected growth promotion, pH, and sterilization requirements.

The Contractor shall process personnel related assessment testing GFS samples according to CAG-009-2011 (or its successor), and 2022 USP <797> standards. GFS results will be reported for each plate, with the amount of colony forming units (cfu) present on each plate reported. If there is no growth present that shall be indicated on the report (0 CFU or < 1

CFU).

The Contractor shall process MFT testing samples according to CAG-009-2011 (or its successor) and 2022 USP <797> standards. MFT results will be reported as negative (pass) or positive (fail); failure is indicated by visible turbidity or other visual manifestations of growth in the media in one or more container–closure unit(s) on or before 14 days.

The Contractor shall process viable surface samples according to the most current version of CAG-009-2011 and 2019 USP <797> standards. If cfu measured during viable sampling exceed USP <797> threshold levels, the report will at minimum identify genus and, when possible, species of any microorganism recovered on the report, in addition to the sample name and the number of CFU. If there is no growth present that shall be indicated on the report (0 CFU or < 1 CFU).

The Contractor shall provide TSA (Tryptic soy agar) Sampling Plates.

2. SCOPE:

The Contractor shall perform routine work detailed in this SOW on a regular schedule, mutually agreed upon by the Contractor and Authorized Government Representative.

The number of surface sampling, gloved fingertip testing (GFS) and media fill testing (MFT) may change throughout the contract period. This is VHSO's best estimate of the number and type expected to be tested and sampled by the contract. VHSO reserves the right to delete or add units as required.

If the numbers of listed items will be exceeded, no work is authorized without the prior written approval of the Contracting Officer (CO) to account for it. Work items or services not already included in this SOW, but relevant to it, may be ordered by the CO without further competition. Only the CO has the right to obligate funding or order work not expressly detailed in this SOW. The Government shall not be held responsible for payment for any work performed by the Contractor that is outside the scope of this contract or without the prior approval of the CO.

3. Task:

a. Bacteria and Fungi surface incubation and sample analysis

b. Gloved Fingertip and Thumb Sample incubation and sample analysis

c. Media Fill Testing sample incubation and sample analysis

Pharmacy IV personnel will conduct gloved fingertip and thumb testing, media fill testing and surface sampling according to USP <797> guidelines and pharmacy needs. The Pharmacy Designated Person or their designee shall collect, label, and prepare all samples for shipping pursuant to instructions provided by the contractor ensuring viability of samples during shipping. Every effort will be made to ship samples the same day as sampled and will be shipped for next day delivery to the contractor according to instructions. If samples are not able to be shipped the same day as sampled, they will be shipped no later than the day after sampling takes place. Days of sampling will be coordinated so delivery occurs according to Contractor’s normal hours.

4. Gloved Fingertip Sampling Plates:

Pharmacy compounding staff must be evaluated in Gloved Fingertip and Thumb Sampling (GFS) to demonstrate competency in garbing and hand hygiene, as set forth in USP <797>.

VHSO will perform GFS on site, using one sampling device per hand (e.g., plates, paddles, or slides) containing general microbial growth agar {e.g., trypticase soy agar (TSA)} supplemented with neutralizing additives (e.g., lecithin and polysorbate 80) as this agar supports both bacterial and fungal growth.

Contractor will incubate fingertip sampling plates immediately upon receipt at a temperature of 30-35° C for no less than 48 hours and then at 20°–25° C for no less than 5 additional days. Sampling plates will be stored during incubation to prevent condensate from dropping onto the agar and affecting the accuracy of the cfu reading (e.g., invert plates). Contractor will record and report the number of cfu per hand (left hand, right hand), as well as the starting temperature for each interval of incubation, dates of incubation, and the identification of the person who reads and documents the results.

Contractor personnel who analyze sampling plates including reading of plates, counting cfu, and performing identification of recovered microorganisms will be a licensed and qualified environmental microbiologist.

Failure is if total cfu for both hands is greater than the action level for the type sampling (i.e., initial or bi-annual). The Contractor will notify the USP Program Manager, or if unavailable, the Chief Pharmacy Services, within 1 (one) business day of any failure.

All results will be transmitted the facility within one business day of final analysis.

Table 1. Action Level for Gloved Fingertip Sampling and Thumb Sampling

*Action levels are based on the total cfu count from both hands.

5. Surface Sample Plates:

Surface sampling plates are preferred over paddles or slides. One plate each of general microbial growth agar [e.g. typticase soy agar (TSA)] supplemented with neutralizing additives (e.g. lecithin & polysorbate 80 will be used at each sampling site.

Microbiological surface monitoring will be performed monthly in the Segregated Compounding Area and all classified areas including:

Pass-through chambers The interior of the Primary Engineering Controls (PECs) and any equipment contained within Staging or work area(s) near the PEC Frequently touched surfaces

* Additional surface sampling may be performed during certification of new facilities and equipment, after servicing facilities or equipment, in response to identified problems, in response to identified trends, or in response to changes that could impact the sterile compounding environment.

One sample of TSA will be obtained per sample location. Contractor will incubate surface sampling plates immediately upon receipt at a temperature of 30-35° C for no less than 48 hours and then at 20°–25°C for no less than 5 additional days. Sampling plates will be stored during incubation to prevent condensate from dropping onto the agar and affecting the accuracy of the cfu reading (e.g., invert plates). If levels measured during surface sampling exceed the levels in USP <797> Table 6, an attempt must be made to identify any microorganism recovered to the genus level, and when possible, to species of the

Gloved Fingertip & Thumb Sampling Action Level* Initial sampling after garbing >0 Subsequent sampling after media-fill testing (every 6 months)

>3 microorganism recovered. Staff direct surface sample readings do not require any additional identification of microorganisms recovered to the genus level.

Contractor will identify which surface sampling method is included with quote.

Contractor will report the number of cfu per plate as well as the starting temperature for each interval of incubation, dates of incubation, and the identification of the person who reads and documents the results. Contractor personnel who analyze sampling plates including reading of plates, counting cfu, and performing identification of recovered microorganisms will be a licensed and qualified environmental microbiologist.

Failure is indicated if cfu of any plate is greater than the action level for the classified area.

The contractor will notify the Pharmacy Designated Person and the Chief of Pharmacy Services, within 1 (one) business day of any failure. All results will be transmitted the facility within one business day of final analysis.

Table 8. Action Levels for Surface Sampling

ISO Class Surface Sampling Action Levels

(cfu per media device) 5 >3 7 >5 8 >50

6. Media Fill Samples:

Media fill tests will be designed and developed by the Pharmacy Designated Person to reflect the most complicated manipulations performed at VHSO. The Contractor will be provided with the final Media Fill Testing sample (one sample) per staff member tested.

Contractor will incubate MFT samples immediately upon receipt at a temperature of 20°– 25°C for 7 (seven) days followed by 7 (seven) days at 30°–35°C to detect a broad spectrum of microorganisms.

Contractor will report pass/fail results as well as the starting temperature for each interval of incubation, dates of incubation, and the identification of the person who reads and documents the results. Contractor personnel who analyze media fill including reading results licensed and qualified environmental microbiologist and or technician.

Failure is indicated by visible turbidity or other visual manifestations of growth in the media in one or more container closure unit(s) on or before 14 days. The contractor will notify the Pharmacy Designated Person and the Chief of Pharmacy Services, within 1 (one) business day of any failure. All results will be transmitted the facility within one business day of final analysis.

7. Place of Performance:

Fayetteville VA Medical Center 1100 N College Avenue Fayetteville, AR 72703-1944

8. Period of Performance:

Base July, 14 2025 – September, 30 2025

Option Period 1 October 01, 2025 – September 30, 2026

Option Period 2 October 01, 2026 – September 30, 2027

Option Period 3 October 01, 2027 – September 30, 2028

Option Period 4 October 01, 2028 – September 30, 2029

Option Period 5 October 01, 2029 – July 13, 2030

Federal Holidays observed by the Medical Center are:

New Years' Day Martin Luther King Day Presidents' Day Memorial Day Juneteenth National Independence Day Independence Day Labor Day Columbus Day Veterans' Day Thanksgiving Day Christmas Day

In addition to the days designated as holidays, the Government observes the following days:

Any other day designated by Federal Statute Any other day designated by Executive Order Any other day designated by the President’s Proclamation

9. Contractor Qualifications:

An ISO/TEC 17025 accredited laboratory under the Environmental Microbiology Lab Accreditation Program (EMLAP). Copies of pertinent certifications, licenses and EMLAP accreditation will be required.

10. Performance Requirement Summary:

a. Facility surface sampling analysis for viable…