36C26125Q0409.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

36C261-25-AP-0695

593-25-1-040-0003

36C26125Q0409 03-26-2025

LaDonna Collins | ladonna.collins@va.gov 04-09-2025

3:30 PM PDT

Department of Veterans Affairs

Network Contracting Office (NCO 21)

X 100

X

541380

$19 Million

N/A

X

"See Delivery Schedule"

FMS-VA-2(101) Financial Services Center

PO Box 149971

Austin TX 78714-9971

See CONTINUATION Page

The contractor shall provide Pharmacy Gloved Fingertip /

Thumb and Media Fill Testing Services, GFT - MFT in accordance with the attached Performance Work Statement.

Period of Performance:

Base plus four (4) Optional Years.

April 23, 2025, through April 22, 2029

This is a 100% SDVOSB set-aside.

Questions will be accepted no later than 12 noon PDT on

Wednesday April 02, 2025, to ladonna.collins@va.gov.

Quotes are due no later than 3:30pm PDT on Wednesday April

09, 2025 to ladonna.collins@va.gov.

Late quotes will not be accepted.

See CONTINUATION Page

36C26125Q0409

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2023)

C.3 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.4 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ...25

C.5 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.6 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.7 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED

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

(DEVIATION)

C.8 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

C.9 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.10 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ..32

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

1998)

E.2 52.201-1 ACQUISITION 360: VOLUNTARY SURVEY (SEP 2023)

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 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

E.6 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.7 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

E.8 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JAN 2025)

E.9 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.10 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE

RESOLUTION (OCT 2018)

E.11 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.12 VAAR 852.239-75 INFORMATION AND COMMUNICATION TECHNOLOGY

ACCESSIBILITY NOTICE (FEB 2023)

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 36C261

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

[X] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] MONTHLY IN ARREARS

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.

Veterans Affairs | Tungsten Network (tungsten-network.com)

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 PRICE/COST SCHEDULE

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

396.00 EA __________________ __________________

1000(SSP) SURF. SINGLE

PLATE -ENUMERATION

Contract Period: Base POP Begin: 04-23-2025 POP End: 04-22-2026

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

160.00 EA __________________ __________________

1004-SURFACE SAMPLE

ORG.ID (SURF)

Contract Period: Base POP Begin: 04-23-2025 POP End: 04-22-2026

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

25.00 EA __________________ __________________

1022 (+) CONTROL-SINGLE

PLATE

Contract Period: Base POP Begin: 04-23-2025 POP End: 04-22-2026

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

747.00 EA __________________ __________________

1047-GLOVED FINGERTIP

(LH)

Contract Period: Base POP Begin: 04-23-2025 POP End: 04-22-2026

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

1048-GLOVED FINGERTIP

(RH)

Contract Period: Base POP Begin: 04-23-2025 POP End: 04-22-2026

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

696.00 EA __________________ __________________

4016-MEDIA FILL

-USP797/825

Contract Period: Base POP Begin: 04-23-2025 POP End: 04-22-2026

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

140.00 EA __________________ __________________

HVMTK-HARDYVAL

-(multi technician)

MEDIA FILL KIT

Contract Period: Base POP Begin: 04-23-2025 POP End: 04-22-2026

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

TOTAL BASE YEAR:

PLATE-ENUMERATION

Contract Period: Option 1 POP Begin: 04-23-2026 POP End: 04-22-2027

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

ORG.ID (SURF)

Contract Period: Option 1 POP Begin: 04-23-2026 POP End: 04-22-2027

PLATE

Contract Period: Option 1 POP Begin: 04-23-2026 POP End: 04-22-2027

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

(LH)

Contract Period: Option 1 POP Begin: 04-23-2026 POP End: 04-22-2027

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

(RH)

Contract Period: Option 1 POP Begin: 04-23-2026 POP End: 04-22-2027

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

-USP797/825

Contract Period: Option 1 POP Begin: 04-23-2026 POP End: 04-22-2027

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

-(multi technician)

MEDIA FILL KIT

Contract Period: Option 1 POP Begin: 04-23-2026 POP End: 04-22-2027

TOTAL OPTION YEAR 1:

PLATE-ENUMERATION

Contract Period: Option 2 POP Begin: 04-23-2027 POP End: 04-22-2028

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

ORG.ID (SURF)

Contract Period: Option 2 POP Begin: 04-23-2027 POP End: 04-22-2028

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

PLATE

Contract Period: Option 2 POP Begin: 04-23-2027 POP End: 04-22-2028

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

(LH)

Contract Period: Option 2 POP Begin: 04-23-2027 POP End: 04-22-2028

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

(RH)

Contract Period: Option 2 POP Begin: 04-23-2027 POP End: 04-22-2028

-USP797/825

Contract Period: Option 2 POP Begin: 04-23-2027 POP End: 04-22-2028

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

-(multi technician)

MEDIA FILL KIT

Contract Period: Option 2 POP Begin: 04-23-2027 POP End: 04-22-2028

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

TOTAL OPTION YEAR 2:

PLATE-ENUMERATION

Contract Period: Option 3 POP Begin: 04-23-2028 POP End: 04-22-2029

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

ORG.ID (SURF)

Contract Period: Option 3 POP Begin: 04-23-2028 POP End: 04-22-2029

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

PLATE

Contract Period: Option 3

POP Begin: 04-23-2028 POP End: 04-22-2029

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

(LH)

Contract Period: Option 3 POP Begin: 04-23-2028 POP End: 04-22-2029

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

(RH)

Contract Period: Option 3 POP Begin: 04-23-2028 POP End: 04-22-2029

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

-USP797/825

Contract Period: Option 3 POP Begin: 04-23-2028 POP End: 04-22-2029

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

-(multi technician)

MEDIA FILL KIT

Contract Period: Option 3 POP Begin: 04-23-2028 POP End: 04-22-2029

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

PLATE-ENUMERATION

Contract Period: Option 4

POP Begin: 04-23-2029 POP End: 04-22-2030

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

ORG.ID (SURF)

Contract Period: Option 4 POP Begin: 04-23-2029 POP End: 04-22-2030

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

PLATE

Contract Period: Option 4 POP Begin: 04-23-2029 POP End: 04-22-2030

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

(LH)

Contract Period: Option 4 POP Begin: 04-23-2029 POP End: 04-22-2030

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

(RH)

Contract Period: Option 4 POP Begin: 04-23-2029 POP End: 04-22-2030

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

-USP797/825

Contract Period: Option 4

POP Begin: 04-23-2029 POP End: 04-22-2030

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

-(multi technician)

MEDIA FILL KIT

Contract Period: Option 4 POP Begin: 04-23-2029 POP End: 04-22-2030

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

GRAND TOTAL __________________

Performance Work Statement

Pharmacy Gloved Fingertip Testing, (GFT – MFT) services

Sacramento VA Medical Center

TASKS and REQUIREMENTS:

An ISO/IEC 17025:2017 accredited laboratory under the Environmental Microbiology Lab

Accreditation Program (EMLAP) will process (incubate, analyze, record and report results) microbiological surface and air samples, Gloved Fingertip and Thumb (GFT) samples and

Media Fill Testing (MFT) samples conducted and submitted by VA Medical Centers in Veterans

Integrated Service Network (VISN) 21. Samples will be processed by the laboratory immediately upon receipt according to the general requirements outlined by ISO/IEC 17025:2017 and 2023

USP <797>.

The contractor shall incubate and process personnel related assessment GFT samples according to 2023 USP <797> standards. GFT results will be reported for each plate, with the amount of colony forming units (cfu) present on each plate reported. No growth present shall be indicated on the report as 0 (zero) cfu or < 1 cfu.

The contractor shall incubate and process personnel related assessment MFT samples according to 2023 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 incubate and process viable surface and air samples according to 2023

USP

<797> standards. Surface and air sample results will be reported in number of cfu. 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. No growth present shall be indicated on the report as 0 (zero) cfu or < 1 cfu.

Shipping the collected samples to the Contractor will be done in collaboration with the VA

Medical facility Pharmacy Service.

The Contractor shall report the receipt of samples via email within two days of receipt. This report shall include the number of samples and their condition.

The media-fill test kits may be provided by the contractor. The plates/paddles will be provided by the facilities in coordination with the Contractor. The samples will be collected by qualified staff of the facilities listed and will be shipped to the Contractor at the cost of the facilities.

SCOPE:

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

(COR).

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.

Fixed pricing for microbial identification shall include all isolates identified on one sample (e.g., per sample plate, per both sides of media paddle).

The service will be performed at 4 different locations within VISN 21.

a. VA Southern Nevada Health Care System: 6900 Pecos Rd., North Las Vegas, NV, 89086

b. VA Palo Alto Health Care System: 3801 Miranda Ave., Palo Alto, CA, 94304- 1207

c. VA Sierra Nevada Health Care System: 975 Kirman Ave., Reno, NV, 89502

d. VA San Francisco Health Care System: 4150 Clement St., San Francisco, CA 94121

TASKS:

Upon request from the VA Medical Center Facility:

a. Gloved fingertip and thumb sample incubation and sample analysis.

b. Media-fill testing sample incubation and sample analysis.

c. Bacteria and fungi surface sample incubation and sample analysis.

d. Bacteria and fungi air sample incubation and sample analysis.

e. Microbial identification to at least the genus level of viable surface samples and viable air samples exceeding the cfu limits listed in 2023 USP <797>.

Gloved Fingertip and Thumb Sampling:

Pharmacy compounding staff must be evaluated in Gloved Fingertip and Thumb (GFT) sampling to demonstrate competency in garbing and hand hygiene and assess aseptic technique and related practices as set forth in 2023 USP <797>. VISN 21 Medical Facility staff will perform GFT onsite, 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. Each media device will be labeled with a personnel identifier, right or left hand, and the date and time of sampling. The plates/paddles will be provided by the facilities in coordination with the Contractor. The samples will be shipped to the Contractor at the cost of the facilities.

Contractor will incubate GFT 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 (five) additional days.

Samples must be incubated in an incubator. 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 and 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 or technician.

Failure is if total cfu for both hands is greater than the action level for the type of sampling (i.e., initial, or biannual) listed in Table 1. The contractor will notify the Facility Program Manager, Inpatient Pharmacy Supervisor and Associate Chief Pharmacy Services, within 1 (one) business day of any failure.

2023 USP <797> Table 1. Action Level for Gloved Fingertip Sampling and Thumb Sampling

Gloved Fingertip & Thumb Sampling Action Level*

After garbing >0

After media-fill testing >3

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

Media-Fill Testing Samples:

Media-fill tests will be designed and developed by the Facility Program Manager to reflect the most complicated manipulations performed by the compounder. The Contractor may provide media-fill test kits as well as incubate and process personnel related assessment MFT samples according to 2023 USP <797>.

Contractor will incubate MFT samples immediately upon receipt at a temperature of 20°–25°C for a minimum of 7 (seven) days followed by a minimum of 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 are a licensed and qualified environmental microbiologist 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

Facility Program Manager the Inpatient Pharmacy Supervisor and the Associate Chief

Pharmacy services, within 1 (one) business day of any failure.

If the VA Medical Facility procures the media-fill test kit from the Contractor, then the Contractor will provide the certificate of analysis (COA). If the VA Medical Facility procures the media-fill test kit from another source, then the COA for the media-fill test kit will be provided by the facility.

Surface-Sample Plates:

Microbiological surface sampling will be performed by VA Medical Facility staff at least monthly in each classified area, at minimum in each room, the interior of each ISO Class 5 Primary

Engineering Control (PEC), and pass-through chambers connecting to classified areas. Surface sampling in the direct compounding area must also be conducted in conjunction with media-fill testing to assess aseptic manipulation competency.

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. Each media device will be labeled with the sample location, as well as personnel identifier if applicable.

Alternate procedure:

For participating sites, all samples will be processed as dual media single incubation as described in USP 2023 <797>. Two surface sampling devices will be collected for each sample location and incubated concurrently. Both media devices could be TSA, or one TSA and one fungal media [e.g., malt extract agar (MEA) or Sabouraud dextrose agar (SDA)]. Contractor would incubate the surface sampling plates immediately upon receipt. Incubate each media device in a separate incubator. Incubate one media device at 30°–35° for no less than 48 hours and incubate the other media device at 20°–25° for no less than 5 (five) days. If fungal media are used, incubate the fungal media device at 20°–25° for no less than 5 (five) 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 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. In addition, if cfu measured during viable surface sampling exceed 2023 USP <797> action levels listed in Table 8 then the report will at a minimum identify genus and, when possible, species of any microorganism identified.

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.

Surface sample results will be reported in number of cfu.

Failure is if cfu of any plate is greater than the action level for the classified area. The contractor will notify the Facility Program Manager, Inpatient Pharmacy Supervisor, and the Associate

Chief Pharmacy services, within 1 (one) business day of any failure.

2023 USP <797> Table 8. Action Levels for Surface Sampling

ISO Class Surface Sampling Action Levels (cfu/device or swab)

5 >3

7 >5

8 >50

Air Sample Requirement

Air sampling may be performed by VA Medical Facility staff at least every six months in each classified area, at minimum in each room, the interior of each ISO Class 5 Primary Engineering

Control (PEC), and pass-through chambers connecting to classified areas.

Additional air 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.

For participating sites, all samples will be processed as dual media single incubation as described in USP 2023 <797>. Two surface sampling devices will be collected for each sample location and incubated concurrently. Both media devices could be TSA, or one TSA and one fungal media [e.g., malt extract agar (MEA) or Sabouraud dextrose agar (SDA)]. Contractor would incubate the surface sampling plates immediately upon receipt. Incubate each media device in a separate incubator. Incubate one media device at 30°–35° for no less than 48 hours and incubate the other media device at 20°–25° for no less than 5 (five) days. If fungal media are used, incubate the fungal media device at 20°–25° for no less than 5 (five) 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 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. In addition, if cfu measured during viable surface sampling exceed 2023 USP <797> action levels listed in Table 7 then the report will at a minimum identify genus and, when possible, species of any microorganism identified.

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.

Surface sample results will be reported in number of cfu.

Failure is if cfu of any plate is greater than the action level for the classified area. The contractor will notify the Facility Program Manager, Inpatient Pharmacy Supervisor, and the Associate

Chief of Pharmacy services, within 1 (one) business day of any failure.

2023 USP <797> Table 7. Action Levels for Viable Airborne Air Sampling

ISO Class Air Sampling Action Levels [cfu/cubic meter (1000 liters) of air/media device]

5 >1

7 >10

8 >100

Period of Performance:

Base Year: April 23, 2025 – April 22, 2026

Option Year 1: April 23, 2026 – April 22, 2027

Option Year 2: April 23, 2027 – April 22, 2028

Option Year 3: April 23, 2028 – April 22, 2028

Option Year 4: April 23, 2029 – April 22, 2029

Contractor: TBD: An ISO/IEC 17025:2017 accredited laboratory under the Environmental

Microbiology Lab Accreditation Program (EMLAP) shall perform the services without outsourcing. Copies of pertinent certifications, licenses, and EMLAP accreditation will be required.

Performance Requirement Summary:

a. Monthly and as needed surface sampling analysis of viable samples taken from the

Segregated Compounding Areas (SCA), Chemo Ante Room, Chemo Buffer Room, IV Ante

Room, IV Buffer, and associated Primary Engineering Controls (PECs) and pass-through chambers connecting to classified areas.

b. Bi-annual and as needed viable air samples taken from the Segregated Compounding

Areas (SCA), Chemo Ante Room, Chemo Buffer Room, IV Ante Room, IV Buffer, and associated Primary Engineering Controls (PECs).

c. Personnel related sampling analysis of the following:

i. Gloved Fingertip and Thumb Sample incubation and sample analysis

ii. Media Fill Testing incubation and sample analysis

iii. Surface sample of the direct compounding area (DCA)

d. Identification of any surface and air sample to at least genus for any growth that exceed the levels in Table 8 and Table 7, and when possible, to species of the microorganism recovered.

Sampling Reports:

For any action levels above the 2023 <USP 797> or MFT failure, the results must be submitted to the Facility Program Manager, Inpatient Pharmacy Supervisor, and the Associate Chief of

Pharmacy services within one (1) business day digitally via email.

The final report must be received within 3 business days of testing completion. The report must include sample identifications and results, incubation dates, incubation period, incubation order and incubation temperatures for each sample. The final report shall also contain the condition of the sample at receipt, the type of media, the lot number, and the expiration date. Failure to follow these procedures may result in delay of payment or nonpayment. Pass/Fail notifications should be included where applicable.

SECTION C - CONTRACT CLAUSES

C.1 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/

(End of Clause)

FAR

Number

Title Date

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

C.2 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:

(End of Addendum to 52.212-4)

C.3 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 .

(End of Clause)

C.4 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 30 days 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.5 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 designation letter shall be furnished to the Contractor.

(End of Clause)

C.6 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)

C.7 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.

(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).

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

(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 qualify as a small business concern under the size standard corresponding to the NAICS code assigned to the contract and be listed as an SDVOSB participant in the SBA certification database as set forth in 13 CFR

128.

(1) Offers received from entities that are not certified SDVOSBs and listed in the SBA certification database at the time of offer shall not be considered.

(2) Any award resulting from this solicitation shall be made to a certified SDVOSB listed in the

SBA certification database 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 certified SDVOSBs listed in the SBA certification database are considered eligible to receive award of a resulting contract. By submitting an offer, the prospective contractor represents that it is an eligible and certified

SDVOSB as defined in this clause, 13 CFR 121, 125, and 128, and VAAR subpart 819.70.

(d) Agreement/LOS certification. When awarded a contract action, including orders under multipleaward 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 (LOS) requirements in 13

CFR 121.406(b) and 13 CFR 125.6.