36C24425Q0125-1.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

693-25-1-093-0137

36C24425Q0125-1 11-19-2024

Christa Stine 570-479-0225 11-25-2024

15:00 EST

36C244

Department of Veterans Affairs

Network Contracting Office 4

Services 5

1111 East End Boulevard

Wilkes-Barre PA 18711

X 100

X

621511

$41.5 Million

N/A

Wilkes-Barre VA Medical Center

ATTN: Warehouse

Donna Tigue

36C244

Department of Veterans Affairs

Network Contracting Office 4

Services 5

1111 East End Boulevard

Austin Payment Center

Department of Veterans Affairs

PO Box 149971

Austin TX 78714-9971

(877) 353-9791 (512) 460-5429

See CONTINUATION Page

GFT Medi Testing Wilkes-Barre VA Medical Center

Submit offers by 11/25/2024 @ 15:00 PM EST.

Email offers to: christa.stine@va.gov

See CONTINUATION Page

X 1

Debra Willard

Contracting Officer mailto:christa.stine@va.gov

36C24425Q0125

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

B.4 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ...27

C.4 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED

SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023)

(DEVIATION)

C.5 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

C.6 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.7 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.9 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2024)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

INSTRUCTIONS TO QUOTERS—COMMERCIAL ITEMS-MICROBIOLOGY TESTING

SERVICES

E.2 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.4 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

E.5 52.216-1 TYPE OF CONTRACT (APR 1984)

E.6 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.7 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.8 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C244

Department of Veterans Affairs

Network Contracting Office 4

Services 5

1111 East End Boulevard

Wilkes-Barre PA 18711

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X]

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment

Requests.

B.2 STATEMENT OF WORK

Statement of Work for Environmental Microbiology Laboratory Analytical Services

1. General Requirements:

Brand name or Equal 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 (GFT) and Media Fill Testing (MFT) samples obtained and submitted by

Wilkes-Barre Veterans Medical Center (WBVAMC). 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>.

MUST BE FDA REGISTERED.

Base plus 4 option years.

Base Year: 12/15/2024 to 12/14/2025

Option Year 1: 12/15/2025 to 12/14/2026

Option Year 2: 12/15/2026 to 12/14/2027

Option Year 3: 12/15/2027 to 12/14/2028

Option Year 4: 12/15/2028 to 12/14/2029

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 will assist in conducting gloved fingertip and thumb testing, media fill testing and surface sampling according to USP <797> guidelines and pharmacy needs.

The Contractor shall assist with the collection, labeling and preparation of all samples.

Days of sampling will be coordinated so delivery occurs according to contractor’s normal hours. The majority of testing will be conducted bi-annually (approximately 35 employees) over two days of testing (on site assistance of approximately 16 hours twice a year). Any additional staff needed outside of the scheduled testing week will be conducted by pharmacy designee and shipped directly to the contractor for analysis.

The contractor shall process personnel related assessment testing GFT samples according to CAG-009-2011 (or its successor), and 2022 USP <797> standards (or newest version). GFT 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 samples according to CAG-009-2011 (or its successor) and 2022 USP <797> standards (or newest version). 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 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).

2. Scope:

The contractor shall perform routine work detailed in this Statement of Work (SOW) on a regular schedule, mutually agreed upon by the Contractor and Contracting Officer

Representave (COR). The majority of the staff will be tested for GFT and Media fill on a twice yearly basis. Any newly hired staff will need to be tested on an adhoc basis according to the start date in the service.

The number of surface sampling, gloved fingertip testing (GFT) and media fill testing

(MFT) may change throughout the contract period. This is WBVAMC’s best estimate of the number and type expected to be tested and sampled by the contract. WBVAMC 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

The Contractor will assist with onsite support hours in conducting gloved fingertip and thumb testing, media fill testing and surface sampling according to USP <797> guidelines and pharmacy needs. The Contractor shall assist with the collection, labeling and preparation of all samples. Days of sampling will be coordinated so delivery occurs according to contractor’s normal hours. The majority of testing will be conducted bi-annually (approximately 35 employees). Any additional staff needed outside of the scheduled testing week will be conducted by pharmacy designee and shipped directly to the contractor for analysis.

4. Gloved Fingertip and Thumb Sampling Plates:

Pharmacy compounding staff must be evaluated in Gloved Fingertip and Thumb

Sampling (GFT) to demonstrate competency in garbing and hand hygiene, as set forth in

USP <797>. The Contractor will perform GFT 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 to the facility within one business day of final analysis.

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

Gloved Fingertip & Thumb Sampling Action Level*

Initial sampling after garbing >0

Subsequent sampling after media-fill testing (every 6 months)

>3

*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 of general microbial growth agar [e.g. typticase soy agar (TSA)] supplemented with neutralizing additives (e.g. lecithin & polysorbate 80).

Microbiological surface monitoring will be performed after bi-annual media fill test is conducted by each employee as well as monthly in the IV room Suite and Segregated

Compounding Contingency Area for both hazardous and non-hazardous compounding and all classified areas including:

• 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.

Contractor will incubate media device(s) immediately upon receipt at a temperature of

30-35° C for no less than 48 hours. Sampling plates will be stored during incubation to prevent condensation from dropping onto the agar and affecting the accuracy of the cfu reading (e.g., invert plates). Contractor will report the total number of discrete colonies of microorganisms on each plate as cfu per sample, with sample location, and sample date. 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 microorganism recovered.

Contractor will incubate media device(s) at a temperature of 20-25° C for no less than 5 additional days. Sampling plates will be stored during incubation to prevent condensation from dropping onto the agar and affecting the accuracy of the cfu reading

(e.g., invert plates). Contractor will report the total number of discrete colonies of microorganisms on each plate as cfu per sample, with sample location, and sample date. 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 microorganism recovered.

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

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 if cfu of any plate is greater than the action level for the classified area. The contractor will notify the Pharmacy Inpatient/USP 797/800 Program Manager and the

Chief of Pharmacy Services, within 1 (one) business day of any failure. All results will be transmitted to the facility within one business day of final analysis.

Table 6. Action Levels for Surface Sampling

ISO

Class

Surface Sampling Action Levels (cfu/device or swab)

5 >3

7 >5

8 >50

6. Media Fill Samples:

Media fill tests will be designed and developed by the Pharmacy Inpatient/USP 797/800

Program Manager to reflect the most complicated manipulations performed at

WBVAMC. 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 Inpatient/USP 797/800 Program Manager and the Chief of

Pharmacy Services, within 1 (one) business day of any failure by utilizing a designated email group as provided by the facility. All results will be transmitted to the facility within one business day of final analysis.

7. Environmental Wipe Sampling for Hazardous Drug Surface residue:

Environmental HD (hazardous drug) surface sampling should be performed routinely, at least every 6 months. The test will be designed and developed by the Pharmacy

Inpatient/USP 797/800 Program Manager to reflect the most commonly used HD medication at WBVAMC at 5 different locations within the facility each time.

Contractor will perform the test and report any measurable contamination (with a limit of quantitation/limit of detection). The contractor will report results to the Pharmacy

Inpatient/USP 797/800 Program Manager and the Chief of Pharmacy Services within one business day of final analysis.

8. Place of Performance:

Wilkes-Barre VA Medical Center

1111 East End Blvd

Wilkes-Barre, PA 18711

570-824-3521 x24135

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 particles from samples taken in the

Segregated Compounding Area (SCA), Chemo Ante Room, Chemo Buffer

Room, IV Ante Room, IV Buffer, and associated Primary Engineering Controls

(PECs)

1. Viable Surface Sampling analysis

2. Identification to at least genus for any growth that exceed the levels in USP <797> Table 6, and when possible, to species of the microorganism recovered.

b. Personnel related assessments include the following:

1. Gloved Fingertip and Thumb Sample incubation and sample analysis

2. Media Fill Testing incubation and sample analysis

3. Surface sample post media fill test incubation and analysis

10. Number of samples:

a. 8 newly hired staff for initial gloved fingertip and thumb sampling, post media-fill testing and surface sampling per year, to include failures if necessary (72 samples).

b. 35 staff bi-annual fingertip and thumb samples (280 samples)

c. 35 media-fill tests bi-annually (70 samples)

d. 35 staff bi-annual surface samplings conducted post media-fill (70 samples)

e. 13 total surface samplings monthly for IV compounding areas, sample locations to be determined by WBVAMC (130 samples)

f. 2 additional surface samplings in the event of a failure to include STAT reporting of result

g. 7 additional bi-annual fingertip and thumb samples in the event of a failure (56 samples)

h. 7 additional media-fill tests bi-annually in the event of a failure (14 samples)

i. 7 additional bi-annual surface samples conducted post media-fill in the event of a failure (14 samples)

j. 5 locations of a hazardous medications bi-annually (10 locations total with 2 medications)

11. Sampling Reports:

Results of viable samples and/or surface sampling must be submitted to the Pharmacy

Inpatient/USP 797/800 Program Manager and the Chief of Pharmacy within one (1) business day of the receipt of the results. Each employee will have their own individual results reported by the contractor to the site. Multiple employees should not be included on the same report. Failure to follow these procedures may result in delay of payment or nonpayment. Pass/Fail notifications should be included where applicable. Each sampling reports shall contain, at a minimum, the following information:

a. An SOP or protocol that describes the process for the handling, incubation and analysis for each sampling plate or MFT.

b. Growth and Sterility Control Reports (where applicable)

c. Signed lab personnel conducting the test results

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBE

R

DESCRIPTION OF

SUPPLIES/SERVI

CES

QUANTI

TY

UNI

T UNIT PRICE AMOUNT

65.00 PG _______________

Tryptic Soy Agar Plates per sleeve (10 plates) Contract Period: Base POP Begin: 12-15-2024 POP End: 12-14-2025 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing MANUFACTURER PART NUMBER (MPN): None

LOCAL STOCK NUMBER: TSA-10

16.00 EA _______________

MEDIUM RISK MEDIA FILL TEST KIT

Contract Period: Base POP Begin: 12-15-2024 POP End: 12-14-2025 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

LOCAL STOCK NUMBER: MEDIA FILL KIT

624.00 EA _______________

Environmental Monitoring (price per plate) Contract Period: Base POP Begin: 12-15-2024 POP End: 12-14-2025 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

LOCAL STOCK NUMBER: EM-001

80.00 EA _______________

Media Fill EM Analysis ANALYSIS OF EM(TBC,TFC,TMC

ONLY)-PER PLATE SUBMITTED. COVERS SURFACE

SAMPLES AND GFT SAMPLES FROM LINE 0001 AND

Contract Period: Base POP Begin: 12-15-2024 POP End: 12-14-2025 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

LOCAL STOCK NUMBER: MF-EM-002

4.00 EA _______________

4 Man Days for On-Site Support (Up to 8 Hours Per Day) Contract Period: Base POP Begin: 12-15-2024 POP End: 12-14-2025 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

LOCAL STOCK NUMBER: OS SUPPORT

2.00 EA _______________

STAT Testing for Retest results ANALYSIS OF

EM(TBC,TFC,TMC ONLY)-PER PLATE SUBMITTED.

COVERS SURFACE SAMPLES AND GFT SAMPLES

Contract Period: Base POP Begin: 12-15-2024 POP End: 12-14-2025 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

LOCAL STOCK NUMBER: EM TEST-STAT

10.00 EA _______________

HD Sampling Locations to include up to one Hazardous Drug per sample location Contract Period: Base POP Begin: 12-15-2024 POP End: 12-14-2025 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

LOCAL STOCK NUMBER: HD SAMPLING

Tryptic Soy Agar Plates per sleeve (10 plates) Contract Period: Option 1 POP Begin: 12-15-2025 POP End: 12-14-2026 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

MEDIUM RISK MEDIA FILL TEST KIT

Contract Period: Option 1 POP Begin: 12-15-2025 POP End: 12-14-2026 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

Environmental Monitoring (price per plate) Contract Period: Option 1 POP Begin: 12-15-2025 POP End: 12-14-2026 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

Media Fill EM Analysis ANALYSIS OF EM(TBC,TFC,TMC

ONLY)-PER PLATE SUBMITTED. COVERS SURFACE

SAMPLES AND GFT SAMPLES FROM LINE 0001 AND

Contract Period: Option 1 POP Begin: 12-15-2025 POP End: 12-14-2026 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

4 Man Days for On-Site Support (Up to 8 Hours Per Day) Contract Period: Option 1 POP Begin: 12-15-2025 POP End: 12-14-2026 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

STAT Testing for Retest results ANALYSIS OF

EM(TBC,TFC,TMC ONLY)-PER PLATE SUBMITTED.

COVERS SURFACE SAMPLES AND GFT SAMPLES

Contract Period: Option 1 POP Begin: 12-15-2025 POP End: 12-14-2026 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

HD Sampling Locations to include up to one Hazardous Drug per sample location Contract Period: Option 1 POP Begin: 12-15-2025 POP End: 12-14-2026 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

Tryptic Soy Agar Plates per sleeve (10 plates) Contract Period: Base POP Begin: 12-15-2026 POP End: 12-14-2027 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

MEDIUM RISK MEDIA FILL TEST KIT

Contract Period: Base POP Begin: 12-15-2026 POP End: 12-14-2027 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

Environmental Monitoring (price per plate) Contract Period: Base POP Begin: 12-15-2026 POP End: 12-14-2027 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

Media Fill EM Analysis ANALYSIS OF EM(TBC,TFC,TMC

ONLY)-PER PLATE SUBMITTED. COVERS SURFACE

SAMPLES AND GFT SAMPLES FROM LINE 0001 AND

Contract Period: Base POP Begin: 12-15-2026 POP End: 12-14-2027 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

4 Man Days for On-Site Support (Up to 8 Hours Per Day) Contract Period: Base POP Begin: 12-15-2026 POP End: 12-14-2027 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

STAT Testing for Retest results ANALYSIS OF

EM(TBC,TFC,TMC ONLY)-PER PLATE SUBMITTED.

COVERS SURFACE SAMPLES AND GFT SAMPLES

Contract Period: Base POP Begin: 12-15-2026 POP End: 12-14-2027 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

HD Sampling Locations to include up to one Hazardous Drug per sample location Contract Period: Base POP Begin: 12-15-2026 POP End: 12-14-2027 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

Tryptic Soy Agar Plates per sleeve (10 plates) Contract Period: Base POP Begin: 12-15-2027 POP End: 12-14-2028 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

MEDIUM RISK MEDIA FILL TEST KIT

Contract Period: Base POP Begin: 12-15-2027 POP End: 12-14-2028 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

Environmental Monitoring (price per plate) Contract Period: Base POP Begin: 12-15-2027 POP End: 12-14-2028 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

Media Fill EM Analysis ANALYSIS OF EM(TBC,TFC,TMC

ONLY)-PER PLATE SUBMITTED. COVERS SURFACE

SAMPLES AND GFT SAMPLES FROM LINE 0001 AND

Contract Period: Base POP Begin: 12-15-2027 POP End: 12-14-2028 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

4 Man Days for On-Site Support (Up to 8 Hours Per Day) Contract Period: Base POP Begin: 12-15-2027 POP End: 12-14-2028 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

STAT Testing for Retest results ANALYSIS OF

EM(TBC,TFC,TMC ONLY)-PER PLATE SUBMITTED.

COVERS SURFACE SAMPLES AND GFT SAMPLES

Contract Period: Base POP Begin: 12-15-2027 POP End: 12-14-2028 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

HD Sampling Locations to include up to one Hazardous Drug per sample location Contract Period: Base POP Begin: 12-15-2027 POP End: 12-14-2028 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

Tryptic Soy Agar Plates per sleeve (10 plates) Contract Period: Base POP Begin: 12-15-2028 POP End: 12-14-2029 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

MEDIUM RISK MEDIA FILL TEST KIT

Contract Period: Base POP Begin: 12-15-2028 POP End: 12-14-2029 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

Environmental Monitoring (price per plate) Contract Period: Base POP Begin: 12-15-2028 POP End: 12-14-2029 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

Media Fill EM Analysis ANALYSIS OF EM(TBC,TFC,TMC

ONLY)-PER PLATE SUBMITTED. COVERS SURFACE

SAMPLES AND GFT SAMPLES FROM LINE 0001 AND

Contract Period: Base POP Begin: 12-15-2028 POP End: 12-14-2029 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

4 Man Days for On-Site Support (Up to 8 Hours Per Day) Contract Period: Base POP Begin: 12-15-2028 POP End: 12-14-2029 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

STAT Testing for Retest results ANALYSIS OF

EM(TBC,TFC,TMC ONLY)-PER PLATE SUBMITTED.

COVERS SURFACE SAMPLES AND GFT SAMPLES

Contract Period: Base POP Begin: 12-15-2028 POP End: 12-14-2029 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

HD Sampling Locations to include up to one Hazardous Drug per sample location Contract Period: Base POP Begin: 12-15-2028 POP End: 12-14-2029 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

GRAND TOTAL _______________

B.4 DELIVERY SCHEDULE

ITEM

NUMBER SHIPPING INFORMATION QUANTITY

DELIVERY

DATE

0001-

SHIP TO: Wilkes-Barre VA Medical Center 1111 East End Boulevard Wilkes-Barre, PA 18711

USA

65.00

MARK FOR: Donna Tigue 570-824-3521x27114 donna.tigue@va.gov

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (NOV 2023)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The

Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered;

and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims

Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the

Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the

Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the

Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by

Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(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.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt

Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-

5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting

Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the

Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the

Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The

Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the

Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain

Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with

Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service

(TOS), or similar legal instrument or agreement, that includes any clause requiring the

Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause)

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

PRODUCTS AND COMMERCIAL SERVICES

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

C.2 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.

(End of Clause)

C.3 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)

C.4 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED SERVICE-

DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023) (DEVIATION)

(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 VAAR

802.201, 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 certified for ownership and control pursuant to 38 U.S.C. 8127, 13 CFR 128, and is listed as certified in the SBA certification database at https://veterans.certify.sba.gov/; and

(v) The business agrees to comply with VAAR subpart 819.70 and Small Business

Administration (SBA) regulations regarding small business size, government contracting, and the Veteran Small Business Certification Program at 13 CFR parts 121, 125, and 128.

https://veterans.certify.sba.gov/

(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)).

(5) The term “SDVOSB participant” or certified SDVOSB means a small business that has been certified in the SBA Veteran Small Business Certification Program and listed in the SBA certification database (see 13 CFR 128.102).

(b) General. In order for a concern to submit an offer and be eligible for the award of an

SDVOSB set-aside or sole source contract, the concern must…