RFQ 36C26124Q0390 - Pharmacy Hood Testing.pdf

PDF 770 KB Posted Jun 13, 2024

Attached to: H266--Pharmaceutical Compounding Room/Hood Testing - VANCHCS Federal contract opportunity
Solicitation number: 36C26124Q0390
Issued by: Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 21

About this file

Written by GovTribe AI · Jun 13, 2024

This document is a Request for Quote (RFQ) for Pharmacy Hood Testing services for the Department of Veterans Affairs Northern California Health Care System (VANCHCS).

The key details are:

The contractor shall provide labor, transportation, parts, and expertise to perform initial and twice-yearly certification of classified pharmacy areas at the Mather VA Medical Center, Martinez Outpatient Clinic, and Stockton Outpatient Clinic. The contractor will also conduct monthly surface sampling as needed. Services must comply with current Controlled Environment Testing Association (CETA) and United States Pharmacopeia (USP) standards.

The base period of performance is August 22, 2024 to August 21, 2025, with four one-year option periods. Pricing is provided for a variety of testing services including airflow, HEPA filter integrity, particle counts, and viable air/surface sampling. The solicitation is set aside for certified Service-Disabled Veteran-Owned Small Businesses. Offers are due by July 8, 2024 at 1:00 PM PDT.

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Other files for this federal contract opportunity

Other files attached to H266--Pharmaceutical Compounding Room/Hood Testing - VANCHCS, newest first.
File	Type	Posted
QUESTIONS AND ANSWERS.pdf	PDF	Jul 9, 2024
Gowning and Garbing procedure VANCHCS.pdf	PDF	Jul 9, 2024
VANCHCS Viable Sample Maps.pdf	PDF	Jul 9, 2024
36C26124Q0390 0003_1.docx	DOCX document	Jul 9, 2024
36C26124Q0390 0002_1.docx	DOCX document	Jul 8, 2024
36C26124Q0390 0001_1.docx	DOCX document	Jun 14, 2024
Past Performance Survey.docx	DOCX document	Jun 14, 2024
2015-5653_Rev.19_SAN JOAQUIN_12_26_2023.pdf	PDF	Jun 13, 2024
2015-5623_Rev.22_ALAMEDA_CONTRA COSTA_12_26_2023.pdf	PDF	Jun 13, 2024
2015-5631_Rev.20_SACRAMENTO_12_26_2023.pdf	PDF	Jun 13, 2024
36C26124Q0390_1.docx	DOCX document	Jun 13, 2024

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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

612-24-4-299-0044

36C26124Q0390 06-13-2024

Durell Salaz 916-923-4385 07-08-2024

1:00 PM PDT

612MCP

Department of Veterans Affairs Network Contracting Office (NCO) 21 3237 Peacekeeper Way, Bldg 200 Suite 204 McClellan CA 95652

X 100

541380

$19 Million

N/A

***See Delivery Schedule***

612MCP

Department of Veterans Affairs Network Contracting Office (NCO) 21 3237 Peacekeeper Way, Bldg 200 Suite 204 McClellan CA 95652

FMS VA-9(101) Financial Services Center

PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page

The Contractor shall provide all labor, transportation, parts, and expertise necessary to provide initial and twice-yearly certification of the classified areas of the Pharmacy Service at the Mather VA Medical Center; Martinez Outpatient Clinic, and Stockton Outpatient Clinic. The Contractor will also be responsible for monthly surface sampling as needed for the VA Northern California Health Care System (VANCHCS).

Base Period of Performance: 08-22-2024 - 08-21-2025

Quote instructions are provided in provision 52.212-1.

Evaluation factors are provided in provision 52.212-2.

Services under this order are subject subject to the Service Contract Act (SCA):

2015-5623 (WD-CONTRA COSTA), REV.22, DATED 12/26/2023

2015-5653 (WD-SAN JOAQUIN), REV.19, DATED 12/26/2023

2015-5631 (WD-SACRAMENTO), REV.20, DATED 12/26/2023

See CONTINUATION Page

612-3640160-299-822400-2670 0100224V1

Anna Norcross Senior Contracting Officer

36C26124Q0390

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 ADMMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

B.3 PERFORMANCE WORK STATEMENT

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)

C.4 SUPPLEMENTAL INSURANCE REQUIREMENTS

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)

C.11 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.12 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (FEB 2024)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 ATTACHMENT 1 – PAST PERFORMANCE SURVEY

D.2 ATTACHMENT 2 – DOL WAGE DETERMINATION 2015-5623, REV.23, DATED

12/26/2023 – CONTRA COSTA

D.3 ATTACHMENT 3 – DOL WAGE DETERMINATION 2015-5631, REV.20, DATED

12/26/2023 – SACRAMENTO

D.4 ATTACHMENT 4 – DOL WAGE DETERMINATION 2015-5653, REV.19, DATED

12/26/2023 – SAN JOAQUIN

SECTION E - SOLICITATION PROVISIONS

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

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT ORDERS—

REPRESENTATION AND DISCLOSURES (DEC 2023)

E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.5 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

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

E.7 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.8 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.9 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

E.10 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.11 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (FEB 2024)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C261

Network Contracting Office (NCO) 21 3237 Peacekeeper Way, Bldg. 200, Suite 204 McClellan, CA 95652

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] Invoice 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.

Invoicing: All invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website:

http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

More information on the VA Financial Services Center is available at http://www.fsc.va.gov/einvoice.asp.

Vendor e-Invoice Set-Up Information:

Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below:

• Tungsten e-Invoice Setup Information: 1-877-489-6135

• Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

• FSC e-Invoice Contact Information: 1-877-353-9791

• FSC e-invoice email: vafsccshd@va.gov

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

AMENDMENT NO. DATE

mailto:VA.Registration@Tungsten-Network.com mailto:vafsccshd@va.gov

B.2 PRICE/COST SCHEDULE

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

14.00 EA __________________

Formal Document Report - All Locations Contract Period: Base POP Begin: 08-22-2024 POP End: 08-21-2025 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services PRODUCT/SERVICE CODE: H266 - Equipment and Materials Testing - Instruments and Laboratory Equipment

24.00 EA __________________

Laminar Flow Unit - Airflow Visualization Study Contract Period: Base POP Begin: 08-22-2024 POP End: 08-21-2025 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Laminar Flow Unit - Particle Count Contract Period: Base POP Begin: 08-22-2024 POP End: 08-21-2025 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Laminar Flow Unit - Test Contract Period: Base POP Begin: 08-22-2024 POP End: 08-21-2025 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

48.00 EA __________________

Cleanroom Test - Particle Counts per room Contract Period: Base POP Begin: 08-22-2024 POP End: 08-21-2025 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

60.00 EA __________________

Room Air Exchange Rate Calculation Contract Period: Base POP Begin: 08-22-2024 POP End: 08-21-2025 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Room Pressure Readings Contract Period: Base POP Begin: 08-22-2024 POP End: 08-21-2025 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

76.00 EA __________________

TAF - Test (airflow and leak test) Contract Period: Base POP Begin: 08-22-2024 POP End: 08-21-2025 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

200.00 EA __________________

Viable Sampling, Airborne: with Colony ID (Required) Mather B700 3X, Mather Trailer 3X, Martinez Crec 3X, Martinez B19 3X Contract Period: Base POP Begin: 08-22-2024 POP End: 08-21-2025 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

308.00 EA __________________

Viable Sampling, Surface: with Colony ID (Resamples) Mather B700 3X, Mather Trailer 3X, Martinez Crec 3X, Martinez B19 3X Contract Period: Base POP Begin: 08-22-2024 POP End: 08-21-2025 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Biosafety Cabinet - Airflow Visualization Study Contract Period: Base POP Begin: 08-22-2024 POP End: 08-21-2025 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Biosafety Cabinet - Particle Count Contract Period: Base POP Begin: 08-22-2024 POP End: 08-21-2025 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Biosafety Cabinet - Test Contract Period: Base POP Begin: 08-22-2024 POP End: 08-21-2025 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

20.00 EA __________________

Supply Register - Velocity Profile Only Contract Period: Base POP Begin: 08-22-2024 POP End: 08-21-2025 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Labor Contract Period: Base POP Begin: 08-22-2024 POP End: 08-21-2025 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

40.00 EA __________________

Pass-through Tests

Contract Period: Base POP Begin: 08-22-2024 POP End: 08-21-2025 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

SEC – Airflow Visualization Studies Contract Period: Base POP Begin: 08-22-2024 POP End: 08-21-2025 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

80.00 EA __________________

Shipping Costs Contract Period: Base POP Begin: 08-22-2024 POP End: 08-21-2025 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option 1 POP Begin: 08-22-2025 POP End: 08-21-2026 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option 1 POP Begin: 08-22-2025 POP End: 08-21-2026

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option 1 POP Begin: 08-22-2025 POP End: 08-21-2026 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Mather Trailer 3X, Martinez Crec 3X, Martinez B19 3X Contract Period: Option 1 POP Begin: 08-22-2025 POP End: 08-21-2026 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option 1 POP Begin: 08-22-2025 POP End: 08-21-2026 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option 2 POP Begin: 08-22-2026 POP End: 08-21-2027 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option 2 POP Begin: 08-22-2026 POP End: 08-21-2027

Contract Period: Option 2 POP Begin: 08-22-2026 POP End: 08-21-2027 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Mather Trailer 3X, Martinez Crec 3X, Martinez B19 3X Contract Period: Option 2 POP Begin: 08-22-2026 POP End: 08-21-2027 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option 2 POP Begin: 08-22-2026 POP End: 08-21-2027

Contract Period: Option 2 POP Begin: 08-22-2026 POP End: 08-21-2027 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option 3 POP Begin: 08-22-2027 POP End: 08-21-2028 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Mather Trailer 3X, Martinez Crec 3X, Martinez B19 3X Contract Period: Option 3 POP Begin: 08-22-2027

POP End: 08-21-2028

Mather Trailer 3X, Martinez Crec 3X, Martinez B19 3X Contract Period: Option 3 POP Begin: 08-22-2027 POP End: 08-21-2028 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option 3 POP Begin: 08-22-2027 POP End: 08-21-2028 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option 3 POP Begin: 08-22-2027 POP End: 08-21-2028

Contract Period: Option 3 POP Begin: 08-22-2027 POP End: 08-21-2028 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option 4 POP Begin: 08-22-2028 POP End: 08-21-2029 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Mather Trailer 3X, Martinez Crec 3X, Martinez B19 3X Contract Period: Option 4 POP Begin: 08-22-2028 POP End: 08-21-2029 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option 4 POP Begin: 08-22-2028 POP End: 08-21-2029 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option 4

POP End: 08-21-2029 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option 4 POP Begin: 08-22-2028 POP End: 08-21-2029 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option 4

POP End: 08-21-2029

Contract Period: Option 4 POP Begin: 08-22-2028 POP End: 08-21-2029 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

GRAND TOTAL

Summary:

PERIOD OF PERFORMANCE TOTAL

Base Period: 08/22/2024 – 08/21/2025 $

Option Period 1: 08/22/2025 – 08/21/2026 $

Option Period 2: 08/22/2026 – 05/21/2027 $

Option Period 3: 08/22/2027 – 08/21/2028 $

Option Period 4: 08/22/2028 – 08/21/2029 $

Grand Total Amount $

B.3 PERFORMANCE WORK STATEMENT

1. The Contractor shall furnish all labor, transportation, parts, and expertise necessary to provide initial and twice-yearly certification of the classified areas of the Pharmacy Service at the Mather VA Medical Center, Martinez Outpatient Clinic, and Stockton Outpatient Clinic. The Contractor will also be responsible for monthly surface sampling as needed. Areas must be certified and sampled using procedures in the current Controlled Environment Testing Association (CETA) certification guide for Sterile Compounding Facilities and be conforming to the current United States Pharmacopeia (USP) chapters <797> and <800>.

1.1. Classified Areas:

1.1.1. Area 1 location:

Department of Veterans Affairs - Northern California Health Care System Mather Odulair Compounding Trailer (behind building 647/649) 10535 Hospital Way Mather, CA 95655

Area 1 access hours:

Contractor allowed access on Monday through Friday, 8:00am to 4:00pm

Work Required:

• Primary Engineering Controls (PECs) o ISO 5 Laminar Flow Hood x one o ISO 5 Biological Safety Cabinet x two

• Secondary Engineering Controls (SECs) o ISO 7 Sterile Injectable Compounding Buffer Room o ISO 7 Hazardous Drug Negative Pressure Buffer Room o ISO 7 Ante Room

1.1.2. Area 2 location:

Mather Inpatient Pharmacy, building 700 – 5th Floor, rooms 5A020, 5A021, and 5A2022.

10535 Hospital Way Mather, CA 95655

Area 2 access hours:

Contractor allowed access on Monday through Friday, 8:00am to 4:00pm

Work Required:

• Primary Engineering Controls (PECs) o ISO 5 Biological Safety Cabinet x one o ISO 7 Anteroom

1.1.3. Area 3 location:

Mather Inpatient Pharmacy, building 700 – 3rd Floor, room 3A103.

10535 Hospital Way Mather, CA 95655

Area 3 access hours:

Contractor allowed access on Monday through Friday, 8:00am to 4:00pm

Work Required:

• Primary Engineering Controls (PECs) o Segregated Compounding Area

1.1.4. Area 4 location:

Mather Oncology Pharmacy, building 647, room 109.

10535 Hospital Way Mather, CA 95655

Area 4 access hours:

Contractor allowed access on Monday through Friday, 8:00am to 4:00pm

Work Required:

o Hazardous Drug Negative Pressure Containment Segregated Compounding Area

1.1.5. Area 5 location:

Martinez Outpatient Pharmacy, building 19, room 193 (B143I non-chemo, B143H chemo) 150 Muir Rd Martinez, CA 94553

Area 5 access hours:

Contractor allowed access on Monday through Friday, 8:00am to 4:00pm

Work Required:

o Negative pressure Hazardous Drugs Storage Room

1.1.6. Area 6 location:

Martinez Continued Living Center (CLC), building 20, room N100.

150 Muir Rd Martinez, CA 94553

Area 6access hours:

Contractor allowed access on Monday through Friday, 8:00am to 4:00pm

Work Required:

o ISO 5 Laminar Flow Hood o Segregated Compounding Area

1.1.7. Area 7 location:

Stockton Outpatient Pharmacy, rooms 1A105M, 1A105P, 1A105T, and 1A105E 6505 South Manthey Rd French Camp, CA 95231

Area 1 access hours:

Contractor allowed access on Monday through Friday, 8:00am to 4:00pm

Work Required:

• Primary Engineering Controls (PECs) o ISO 7 Hazardous Drug Negative Pressure Buffer Room o Negative Pressure Hazardous drug storage room

2. SERVICES TO BE PROVIDED: The certification testing of each area will be performed twice-yearly (no less than every six-months). Monthly surface sampling will always occur during the certification testing and on an as-needed basis for the remainder of the months. Initial certification of new compounding suites listed under 2. Will be performed as needed.

2.1. The following testing services will be performed for twice yearly certification:

2.1.1. Airflow Testing

o Air Velocity of PECs in Area 1, Area 2, Area 3, Area 4, Area5, Area 6, and Area 7.

o Air Volume (ACPH from HVAC, ACPH from PEC(s), total ACPH) of SECs in Area 1, Area 2, Area 4, Area 5, and Area 7 o Pressure Differentials: (in doorways between adjacent rooms) of SECs in Area 1, Area 2, Area 4, Area 5, and Area 7.

2.1.2. HEPA Filter Integrity Testing Leak Test (Aerosol or equivalent) o PECs in Area 1, Area 2, Area 3, Area 4, Area 5, Area 6, and Area 7.

o SECs in in Area 1, Area 2, Area 4, Area 5, and Area 7.

2.1.3. Dynamic Airflow Smoke Pattern Test with report of number of personnel present o SECs om Area 1, Area 2, Area 4, Area 5, and Area 7 as needed.

2.1.4. Total Airborne Particle Count: Dynamic with report of number of personnel present for the following:

o SECs in Area 1, Area 2, Area 4, Area5, and Area 7.

2.1.5. Microbiological Air Monitoring with viable impact volumetric particulate sampling for microbial and fungal growth including speciation of CFUs.

o SECs in Area 1, Area 2, Area 3, Area 4, Area 5, Area 6, and Area 7.

2.1.6. Viable surface sampling for microbial and fungal growth including speciation of CFUs.

o SECs in Area 1, Area 2, Area 3, Area 4, Area 5, Area 6, and Area 7.

2.2. Additional tests and inspections related to the pharmacy regulatory testing and inspections may be added and will be considered in scope for the purposes of future modifications. In the event of failure of any of the above tests, retesting must occur.

3. METHOD

3.1. Testing must comply with CETA CAG-003-2006 (or successor) in combination with the cross referenced CETA-CAGs and be conforming to USP <797> and <800>. The method and supplies used will be described in the test report issued by the vendor. Testing must be validated with a negative control when applicable. A proper number of tests will be performed for each service as dictated by current standards. Testing locations will be provided by VA Northern California Health Care System and mapped by the contractor.

4. DELIVERABLE/REPORTING

4.1. The Contractor shall

• Issue a Certification Report.

• The Certification Report will include a map of the testing locations.

• The Certification Report will include the Air Changes Per Hour (ACPH) from HVAC, contributed from PEC, and total.

• Report the results to the CSP Pharmacist.

• Report the certification results (excluding viable surface and air samples) within 2 business days from the time of initial testing.

• Reporting results of collected viable surface and air samples will not exceed 15 business days from the time of the initial testing.

• Report the results with current enforceable compendial ISO class and action levels including colony IDs for all CFUs.

• Cross-reference nonconforming results to specific testing standards.

• Sign, date, and approve the report.

5. SPECIAL INSTRUCTIONS

5.1. The contractor will contact the Contracting Officers Representative (COR) and Compounded Sterile Preparations (CSP) Pharmacist prior to performing any testing in order to schedule a date and time acceptable to each party.

5.2. The service representative(s) will be required to check in with the CSP Pharmacist or Pharmacy Manager upon arrival and departure from the pharmacy area.

5.3. The service representative(s) will always be escorted by pharmacy personnel while within the pharmacy.

5.4. Pharmacy will provide the PPE needed to perform the testing including gowns, gloves, shoe covers, masks and hair covers.

6. CONTRACTOR QUALIFICATIONS/TECHNICAL CAPABILITES

6.1. In order to be considered for the award, the offeror must demonstrate the ability to provide adequate and qualified staff and equipment to satisfy the requirements below:

6.1.1. Provide copies of the certifications and licenses held by the contractor performing the work.

Certifications / licenses must include ISO 9001, National Environmental Balancing Bureau, Controlled Environment Testing Association (CETA)

6.1.2. Provide the name, job title, and a copy of the certifications held by the employees who will be performing the work. The contractor shall have technicians certified to at least National Sanitation Foundation (NSF) 49 or American National Standard (ANSI) 49.

6.1.3. Provide the name of any subcontractor that will be utilized during the performance of this contract along with a detailed description of work to be performed by subcontractors. If no tasks are to be subcontracted, provide a statement to that effect.

6.2. Past Performance: References will be contacted, and information sought to verify the service provided by the contractor, the period of performance, the quality of the contractor’s performance, and any issues that may have occurred during contract performance.

6.2.1. Contractor shall provide a list of at least three (3) current or recent contracts/agreements for the same or similar services being sought. At a minimum, provide the name and address of the facility, contact name, and phone number.

7. OPTIONAL SITE VISIT

7.1. Site visits for potential quoters may be coordinated with the Contracting Officer’s Representative (COR), Wendi Purcell, Procurement Pharmacy Technical Supervisor, 916-640-8033.

8. CONTRACT PERIOD: See Price Schedule

9. TERMS AND CONDITIONS

9.1. QUALIFICATIONS: The contractor will provide a service representative that is Controlled Environment Testing Association (CETA) certified.

9.2. EXCLUSIONS: Service does not include work external to or not associated with the areas and work in this Performance Work Statement.

9.3. INFORMATION SECURITY: The contractor will not access any computer system or protected health information at the VA Northern California Health Care System. The C&A requirements do not apply, and that a Security Accreditation Package is not required.

10. RECORDS MANAGEMENT

10.1. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33;

Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

10.2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

10.3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

10.4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

10.5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

10.6. The Government Agency owns the rights to all data/records produced as part of this contract.

10.7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

10.8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974.

These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

10.9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

10.10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract.

The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

(END OF PERORMANCE WORK STATEMENT)

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.

(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.

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;

(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.

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File details come from the government source that posted it. Updated Jun 13, 2024.