36C24726Q0220_2 Combined Soliciation Pharmacy Lab Services RFQ Amendment.pdf

Combined Synopsis/Solicitation Notice

RFQ AMENDMENT

Environmental laboratory specimen sampling required for compounding pharmacies.

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 30901

SOLICITATION NUMBER* 36C24726Q0220_2

RESPONSE DATE/TIME/ZONE 01/23/2026 12:00 PM EASTERN TIME, NEW

YORK, USA

ARCHIVE 15 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

SET-ASIDE None PRODUCT SERVICE CODE* Q301 – Medical Reference Testing NAICS CODE* 541380- Testing Laboratories and Services

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs 501 Greene Street Hatcher Building-Ste 2

Augusta, GA 30901

POINT OF CONTACT*

Holly Bowling Holly.Bowling@va.gov

PLACE OF PERFORMANCE

ADDRESS Department of Veterans Affairs Charlie Norwood VA Medical Center

1 Freedom Way

DESCRIPTION

General Information

Contracting Office Address

VISN 07

Network Contracting Office 7 501 Greene St.

Augusta, GA 30901

Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” 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 an Open Market with no set aside. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2022-06 effective December 30, 2022.

The associated North American Industrial Classification System (NAICS) code for this procurement is 541380 | Testing Laboratories and Services, with a small business size standard of $19 million.

The FSC/PSC is Q301 | Medical- Reference Laboratory Testing.

Document Type: Combined Solicitation/Synopsis Amendment Solicitation Number: 36C24726Q0220_2 Posted Date: January 19, 2026 Current Response Date: January 23, 2026 at 12:00 p.m. (EST) Product or Service Code: Q301 | Medical- Reference Laboratory Testing

NAICS Code: 541380 | Testing Laboratories and Services

All interested companies shall provide quotations for the following Environmental laboratory specimen sampling required for compounding pharmacies.

Item Number

Description Quantity Unit Price

USP 797 Gloved Fingertip Single Plate/

Surface Samples 450

USP 797 Media-Fill Test Analysis

Additional Sequencing for Identification per Isolate 50

Contact Plates-TSA with Lecithin and Tween 80 - Aseptically

Poured-10/sleeve 45

USP-797-Media-Fill Test Kit

Drop Shipment Charge

Total Contract Price:

Place of Performance/Place of Delivery

Name: Charlie Norwood VA Medical Center Address: 1 Freedom Way

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions apply to this acquisition:

1. FAR 52.212-1, “Instructions to Offerors—Commercial Products and Commercial Services” (Nov 2021) http://acquisition.gov/comp/far/index.html

2. FAR 52.212-3, “Offeror Representations and Certifications—Commercial Products and Commercial Services” (May 2022)

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 Items.” If paragraph (j) of the provision is applicable, a written submission is required.

The following contract clauses apply to this acquisition:

• FAR 52.212-4 Contract Terms and Conditions–Commercial Items (NOV 2021)

• 52.204-13, System for Award Management Maintenance (OCT 2018)

• 52.204-18 Commercial and Government Entity Code Maintenance (AUG 2020)

• 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (NOV 2021

• 852.212-70 Provisions and Clauses Applicable to VA Acquisition of Commercial Items (APR 2020)

The following subparagraphs of FAR 852.203-70 are applicable:

• 852.203-70, Commercial Advertising

• 852.212-71, Gray Market and Counterfeit Items

• 852.242-71, Administrative Contracting Officer

• FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders (Jan 2021)

The following subparagraphs of FAR 52.212-5 are applicable:

52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2022) 52.219-28 Post Award Small Business Program Rerepresentation (NOV 2020) 52.222-3 Convict Labor (JUN 2003) 52.222-19 Child Labor--Cooperation with Authorities and Remedies (JAN 2020) 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 (OCT 2020) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) 52.225-1 Buy American-Free Trade Agreements-Israeli Trade Act (JAN 2021) Alternate I (JAN 2021) 52.225-13 Restrictions on Certain Foreign Purchases (JUN 2008) 52.232-33 Payment by Electronic Funds Transfer – System for Award Management [OCT 2018]

All quoters shall submit the following:

• Offer (pricing) for All Items Listed

All quotes shall be sent to the Holly Bowling via email Holly.Bowling@va.gov.

https://www.sam.gov/portal mailto:Holly.Bowling@va.gov

Award will be based upon lowest priced, technically acceptable quote in accordance with the Simplified Acquisition Procedures of FAR 12.

BASIS FOR AWARD:

As this is a BRAND NAME OR EQUAL TO only requirement the award decision will be based solely on the price of all quotes received.

Once the Government determines there is/are a contractor(s) that can provide equipment that meet(s) the requirements of this request for quote, the Government reserves the right to communicate with only those contractors quoting the best-suited equipment and service to address any remaining issues.

Responses should contain your best terms, conditions.

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS

Provisions that are incorporated by reference (by Citation Number, Title, and Date), have 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 version of FAR 52.212-1 in the addendum is tailored for Simplified Acquisition Procedures and supersedes the current version of FAR 52.212-1 contained in the FAR.

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

52.212-1 INSTRUCTIONS TO QUOTERS—COMMERCIAL ITEMS

(a) North American Industry Classification System (NAICS) code and small business size standard are stated in the combined synopsis/solicitation.

(b) Submission of quotations. Submit quotations to the office specified in this solicitation at or before the exact time specified in this solicitation. Quotations may be submitted on letterhead stationery, or as otherwise specified in the solicitation. As a minimum, quotations must show-

(1) The solicitation number;

(2) The time specified in the solicitation for receipt of quotations;

(3) The name, address, and telephone number of the quoter;

(4) A technical description of the items being quoted in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary;

(5) Terms of any express warranty;

(6) Price and any discount terms;

(7) “Remit to” address, if different than mailing address;

(8) A completed copy of the representations and certifications at FAR 52.212-3 (see FAR 52.212-3( b ) for those representations and certifications that the quoter shall complete electronically);

(9) Acknowledgment of Solicitation Amendments;

(10) Past performance information, when included as an evaluation factor, to include recent and relevant contracts for the same or similar items and other references (including contract numbers, points of contact with telephone numbers and other relevant information); and

(c) Period for acceptance of quotes. The quoters agrees to hold the prices in its offer firm for 30 calendar days from the date specified for receipt of quotes, unless another time period is specified in an addendum to the solicitation.

(d) Product samples. When required by the solicitation, product samples shall be submitted at or prior to the time specified for receipt of quotations. Unless otherwise specified in this solicitation, these samples shall be submitted at no expense to the Government, and returned at the sender’s request and expense, unless they are destroyed during testing.

(e) Late submissions

(1) Quoters are responsible for submitting quotations so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that quotations are due.

(2) Any quotation received at the Government office designated in the solicitation after the exact time specified for receipt of quotations is late and will not be considered unless it is received before purchase order issuance and the Contracting Officer determines that accepting the late quotation would not unduly delay the acquisition.

(3) If an emergency or unanticipated event interrupts normal Government processes so that quotations cannot be received at the Government office designated for receipt of quotations by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of quotations will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

(f) Issuance of purchase order. Quotations should contain the quoter’s best technical and price terms. The Contracting Officer may reject any or all quotations. The Contracting Officer may issue a purchase order to other than the quoter with the lowest priced quotation. After the evaluation of quotations, the Contracting Officer may negotiate final terms with one or more quoters of the Government’s choice before issuing any purchase order. The Contracting Officer will not negotiate with any quoters other than those of the Government’s choice and will not use the formal source selection procedures described in FAR part 15.

(g) Multiple purchase orders. The Government may issue a purchase order for any item or group of items of a quotation, unless the quoter qualifies the quotation by specific limitations.

Unless otherwise provided in the Schedule, quotations may not be submitted for quantities less than those specified. The Government reserves the right to issue a purchase order for a quantity less than the quantity quoted, at the unit prices quoted, unless the quoter specifies otherwise in the quotation.

(h) Availability of requirements documents cited in the solicitation.

(1) (i) The GSA Index of Federal Specifications, Standards and Commercial Item Descriptions, FPMR Part 101-29, and copies of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained for a fee by submitting a request to-

GSA Federal Supply Service Specifications Section Suite 8100 470 East L’Enfant Plaza, SW Washington, DC 20407 Telephone (202) 619-8925 Facsimile (202) 619-8978

(ii) If the General Services Administration, Department of Agriculture, or Department of Veterans Affairs issued this solicitation, a single copy of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained free of charge by submitting a request to the addressee in paragraph (i)(1)(i) of this provision. Additional copies will be issued for a fee.

(2) Most unclassified Defense specifications and standards may be downloaded from the following ASSIST websites:

(i) ASSIST (https://assist.dla.mil/online/start/).

(ii) Quick Search (http://quicksearch.dla.mil/).

(iii) ASSISTdocs.com (http://assistdocs.com).

(3) Documents not available from ASSIST may be ordered from the Department of Defense Single Stock Point (DoDSSP) by-

(i) Using the ASSIST Shopping Wizard (https://assist.dla.mil/wizard/index.cfm);

(ii) Phoning the DoDSSP Customer Service Desk (215) 697-2179, Mon-Fri, 0730 to 1600 EST; or

(iii) Ordering from DoDSSP, Building 4, Section D, 700 Robbins Avenue, Philadelphia, PA 19111-5094, Telephone (215) 697-2667/2179, Facsimile (215) 697-1462.

(4) Nongovernment (voluntary) standards must be obtained from the organization responsible for their preparation, publication, or maintenance.

(i) Data Universal Numbering System (DUNS) Number. (Applies to all quotations exceeding the Micro-Purchase Threshold (MPT), and quotations of MPT or less if the solicitation requires the Contractor to be registered in the System for Award Management (SAM) database.) The quoter https://assist.dla.mil/online/start/ http://quicksearch.dla.mil/ https://assist.dla.mil/wizard/index.cfm shall enter, in the block with its name and address on the cover page of its quotation, the annotation “DUNS” or “DUNS+4” followed by the DUNS or DUNS+4 number that identifies the quoter’s name and address. The DUNS+4 is the DUNS number plus a 4-character suffix that may be assigned at the discretion of the quoter to establish additional SAM records for identifying alternative Electronic Funds Transfer (EFT) accounts (see FAR Subpart 32.11) for the same concern. If the quoter does not have a DUNS number, it should contact Dun and Bradstreet directly to obtain one. A quoter within the United States may contact Dun and Bradstreet by calling 1-866-705-5711 or via the internet at http://fedgov.dnb.com/webform. A quoter located outside the United States must contact the local Dun and Bradstreet office for a DUNS number. The quoter should indicate that it is a quoter for a Government contract when contacting the local Dun and Bradstreet office.

(j) [Reserved].

(k) Requests for information. The contracting officer will not notify unsuccessful quoters that responded to this solicitation. Quoters may request information on purchase order(s) resulting from this solicitation from the contracting officer.

Submission of your response shall be received not later than January 23, 2026 @ 12:00 PM EST. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). All offers shall be emailed to the Contract Specialist listed below no later than the date and time listed. Please ensure you title your quote with the solicitation number and name for ease of identity i.e. “36C24726Q0220: Pharmacy Lab Services.

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below.

Point of Contact

Questions must be submitted NO LATER THAN January 21, 2025 @ 12:00 P.M. EST.

Questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Contract Specialist Holly.Bowling@va.gov. No phone call shall be accepted.

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested.

This solicitation is issued as a BRAND NAME OR EQUAL TO RFQ.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2024-03 effective February 23, 2024.

http://fedgov.dnb.com/webform

The associated North American Industrial Classification System (NAICS) code for this procurement is 541380 | Testing Laboratories and Services, with a small business size standard of $19 million.

The FSC/PSC is Q301 | Medical- Reference Laboratory Testing.

All interested companies shall provide quotations for the following

STATEMENT OF WORK

A. GENERAL INFORMATION

1. Purpose: To provide laboratory environmental microbiology testing of surface samples and glove fingertip (GFT) samples as required by United State Pharmacopeia (USP) Chapter 797 at the VA Augusta Health Care System (VAAHCS).

2. Scope of Work: Upon receipt, the contracted laboratory will review all samples and provide results within 14 days. The details of this work are outlined in section B. General Requirements, of this document

3. Background: USP Chapter 797 requires all compounding pharmacies to conduct surface and GFT samples.

4. Performance Period: The period of performance is for an initial base year with the possibility of four one-year extension options (exercised at the government's discretion) if successful results are achieved per VAAHCS evaluation.

Base Year: 1 May 2026 – 30 April 2027

Option Year 1: 1 May 2027 – 30 April 2028

Option Year 2: 1 May 2028 – 30 April 2029

Option Year 3: 1 May 2029 – 30 April 2030

Option Year 4: 1 May 2030 – 30 April 2031

5. Type of Contract: Firm-Fixed-Price.

6. Place of Performance: Delivery will be made to VA Augusta Health Care System, Warehouse Bldg 95, 1 Freedom Way, Augusta GA 30904.

7. Hours of Operation: Warehouse deliveries are accepted between 8am and 3:30pm, Monday through Friday, excluding holidays.

Hospital normal hours of operation are between 8:00am and 4:30pm, Monday through Friday, excluding holidays. Holidays falling on a Sunday will be observed the following Monday.

Federal Holidays

New Year’s Day January 1st Martin Luther King’s Birthday 3rd Monday in January President’s Day 3rd Monday in February Memorial Day Last Monday in May Juneteenth June 19th Independence Day July 4th Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veteran’s Day November 11th Thanksgiving Day Last Thursday in November Christmas Day December 25th

B. GENERAL REQUIREMENTS

1. The laboratory must be certified by the AIHA Laboratory Accreditation Program (AIHA-LAP) for environmental microbiology.

2. The company will supply CNVAMC with Trypticase Soy Agar (TSA) contact plates with lecithin and polysorbate 80 to conduct surface sampling and GFT sampling as needed by the Medical Center. The Medical Center will decide the amount of plates that are to be sent at one time by the lab.

3. Surface sampling will be conducted monthly and GFT sampling will be conducted every 6 months and on an as needed basis.

4. GFT samples will only be tested for total microbial counts. Species identification is not required. The total colony count will be reported.

5. Surface samples will be tested for total microbial counts. Any growth will require identification. At minimum the genus of the microorganism must be identified.

6. Agar plates will be incubated as required in USP Chapter 797.

a. Current incubation requirements are 30-35oc for 48 hours followed by 20-25oc for 5 additional days for 7 total days of incubation.

7. Results will be reported to the Medical Center within 14 days of receipt of samples.

8. A formal lab report will be emailed to the Medical Center and must include the following information:

a. Lab Sample #

b. Facility Sample #

c. Facility Sample Location

d. Test performed

e. Results: CFU count, Speciation Identification

C. GOVERNMENT RESPONSIBILITIES

VAAHCS will conduct required IV room surface sampling and GFT sampling and ship samples directly to the lab for analysis. Samples will be shipped overnight via postal service or UPS.

D. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project.

Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

E. MONITORING PROCEDURES

The COR shall be responsible for monitoring the Contractor's performance. Performance deficiencies or poor performance identified during the term of the contract shall be reported to the Contractor. Upon notification of deficiencies or poor performance, the Contractor shall be given a reasonable time to take corrective action. If determined appropriate, the Contracting Officer, COR and/or other VA staff members shall meet with representatives of the Contractor to review performance and resolve issues. All deficiencies or poor performance shall be documented and MUST be corrected within the timeframe specified in the cure notice. The Contractor shall notify the Contracting Officer and the COR when correction(s) have been made. If the appropriate correction is not made within the timeframe specified in the cure notice, the Government shall have the right to terminate the contract in its entirety.

Performance Indicators

PWS

Ref

Performance Measure

Acceptable Level of Quality

Method of Assessment Incentive Dis-incentive

The laboratory must maintain certification through AIHA Laboratory Accreditation Program (AIHA- LAP) for

Para B1

Laboratory will maintain 100% compliance with accrediting body

100% 100% Inspection

Positive Past Performance

Negative

Report

Indicators

PWS

Ref

Performance Measure

Acceptable Level of Quality

Method of Assessment Incentive Dis-incentive environmental microbiology.

Vendor will provide all supplies the facility needs to conduct sampling.

Para B2

Timeliness of shipment

100% Direct Observation and User Survey

Positive Past Performance

Negative Performance Report

Surface sampling will be conducted monthly. Surface samples will be tested for total microbial counts.

Any growth will require identification. At minimum the genus of the microorganism must be identified.

Para B3 and B5

Report of results within in 14 days

100% 100% Inspection

Positive Past Performance

Negative Performance Report

Glove fingertip (GFT) will be conducted every 6 months or on an as needed basis. GFT samples will only be tested for microbial counts. The total colony count will be reported.

Para B3 and B4

Report of results within in 14 days

100% 100% Inspection

Positive Past Performance

Negative Performance Report

Formal lab reports will be emailed to the medical center within 14 days of receipt of samples.

Report will need to include all the items listed in section B. 9.

in the statement of work.

Para B7

Report of results within in 14 days

100% Direct Observation and User Survey

Positive Past Performance

Negative

Report

F. INVOICES

1. Payment will be made upon receipt of a properly prepared detailed invoice, prepared by the Contractor, validated by the Contracting Officer’s Representative (COR), and submitted electronically through OB-10 (https://portal.tungsten-network.com/).

2. A properly prepared invoice will contain:

a) Invoice Number and Date

b) Contractor’s Name and Address

b) Accurate Purchase Order Number

c) Supply or Service provided

d) Total Amount Due

E. SECURITY

PER REVIEW OF VA HANDBOOK 6500.6, CONTRACT SECURITY, APPENDIX A-

INFORMATION SECURITY AND PRIVACY CHECKLIST:

1. “The C&A requirements do not apply and a Security Accreditation Package is not required.”

2. Acquisition of this service does not involve the storage, generating, transmitting, or exchanging of VA sensitive information to the vendor.

3. There may exist exposure to VA sensitive information, in particular to sensitive personal information (SPI) while implementing contractual services.

https://portal.tungsten-network.com/