36C26025Q0756.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

653-25-4-030-0550

36C26025Q0756 08-18-2025

Brian Millington 253-888-4914 08-28-2025

16:30 PDT

36C260 NCO 20 Network Contracting Office

ATTN: V4CONT

1601 E. Fourth Plain Blvd Bldg.17, Suite B428 Vancouver WA 98661

X 100

X

541350

$11.5 Million

NET 30

N/A

X

36C260

Department of Veterans Affairs Network Contracting Office 20 See Section B.3 Delivery Schedule 1495 Wilmington Drive, Suite 360 DuPont WA 98327

36C260

NCO 20 Network Contracting Office

ATTN: V4CONT

1601 E. Fourth Plain Blvd Bldg.17, Suite B428

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971

The Roseburg VAMC has a requirement for a contractor to provide Pharmacy Hood Testing and Certification service IAW the incorporated Statement of Work.

This solicitation is 100% set-aside for Service Disabled Veteran Owned Small Business (SDVOSB).

Offerors shall thoroughly review the quote preparation in Section E.9.

Emailed questions are due NLT 08/25/2025 at 16:30 PDT.

Quotes are due NLT 08/28/2025 at 16:30 PDT.

Email questions and quotes to: brian.millington@va.gov

653-3650160-030-822400-2560 010022400 x X

Brian Millington Contracting Officer

6C26025Q0756

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 STATEMENT OF WORK

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE ............................................. Error! Bookmark not defined.

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (NOV 2023)

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

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)

C.5 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED

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

(DEVIATION)

C.6 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

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

C.8 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.9 VAAR 852.222-71 COMPLIANCE WITH EXECUTIVE ORDER 13899. (DEVIATION)

(APR 2025)

C.10 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.11 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JAN 2025) (DEVIATION FEB 2025)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 WAGE DETERMINATION

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (SEP 2023)

E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

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 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

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

E.8 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.9 ADDENDUM TO FAR 52.212-1. ADDITIONAL QUOTE PREPARATION

INSTRUCTIONS AND QUESTIONS

E.10 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024) (DEVIATION

FEB 2025)

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 36C260 NCO 20 Network Contracting Office

ATTN: V4CONT

1601 E. Fourth Plain Blvd Bldg.17, Suite B428

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] In arrears after service

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.

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

AMENDMENT NO DATE

B.2 STATEMENT OF WORK

STATEMENT OF WORK

STATEMENT OF WORK PART A – GENERAL INFORMATION

A.1. INTRODUCTION: This requirement is for testing and certification of all the RVAHCS compounding personnel, primary engineering controls (PECs), sterile clean rooms used for preparation of Compounded Sterile Preparations (CSPs), and Segregated Compounding Areas (SCAs). PECs include biological safety cabinets (BSCs), containment ventilated enclosures (CVE), laminar airflow workstations (LAFWs) hoods, and compounding aseptic isolators (CAI).

Testing and certification will be completed in accordance with United States Pharmacopeia (USP) Chapter <797> 2022 (or most recent) guidelines, USP Chapter <800> 2020 (or most recent) guidelines, and Controlled Environment Testing Association (CETA) Certification Guide for Sterile Compounding Facilities for USP Compliance (CAG-003).

A.1.1. VA Points of Contact:

Eric Okazaki, Pharm.D., BCPS Compounded Sterile Prep (CSP) Program Manager Email: eric.okazaki1@va.gov

Jennifer Andrecht, CPhT Pharmacy Administration Officer Email: jennifer.andrecht@va.gov

Souichi Wood, Pharm.D. Facility Procurement Program Manager

Email: souichi.wood@va.gov

A.2. BACKGROUND: RVAHCS is pursuing a system-wide contract for standardizing testing criteria pursuant to USP Chapter <797> and Chapter <800> standards (or current version) using Controlled Environment Testing Association (CETA) Certified National Board of Testing (CNBT) certified individuals/companies to establish consistent testing and certification procedures using the CETA Certification Guide for Sterile Compounding Facilities for USP Compliance (CAG-003) 2022 (or current) version. Documentation of competency and training related to the certification of the technician(s) who conduct on-site certification will be provided by the contractor.

The USP establishes standards for cleanroom design, environmental monitoring, and competencies for compounding personnel involved in the preparation, handling, and storage of CSPs. The Joint Commission (TJC) Accreditation Manual for Home Care establishes Medication Compounding (MC) standards for non-sterile and sterile compounded preparations which are based on USP standards. The Food and Drug Administration (FDA) has the authority to inspect VA medical facilities under the FD&C Act and applying the Insanitary Conditions at Compounding Facilities Guidance for Industry, November 2020 (or current version).

Certification procedures defined in CETA CAG including, but not limited to, 003 (CETA Certification Guide for Sterile Compounding Facilities for USP Compliance), 008 (Certification matrix for Sterile & Nonsterile USP Compounding Facilities), 009 (Viable Environmental Monitoring for Sterile Compounding Facilities), and 014 (Airflow Visualization Study), shall be performed by a CETA National Board of Testing (CNBT) certified testing individual/company no less than every 3 months or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performed. Testing and assessment of compounding personnel defined in USP <797> (or current version) using CETA CAG including, but not limited to, 009 (Viable Environmental Monitoring for Sterile Compounding Facilities), 011 (Gloved Fingertip Testing for Sterile Compounding Personnel), and 013 (Media Fill Testing for Sterile Compounding Personnel) shall be performed by a CETA National Board of Testing (CNBT) certified testing individual/company no less than every 3 months or whenever additional testing for remediation or initial competencies is needed.

A.3. SCOPE OF WORK:

A.3.1. NSF 49 Field Testing Requirements for Class I Biological Safety Cabinets:

The contractor shall certify all Class I biosafety cabinets—Containment Ventilated Enclosure (CVE)—to the manufacture standards and current version of NSF/ANSI 49-2024 (or higher).

Any unit that fails to meet specifications shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice. In addition, any failures shall be reported directly to the site point of contact (POC) as soon as practicable. All annual and semi-annual on-site certifications of the CVE shall be in accordance with the manufacture standards and current version of NSF/ANSI 49-2024 (or higher). For each CVE passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information:

Company name and address Unit make, model and serial number Report number Location (room number) Certification date Date of next required recertification date Technician signature

A.3.2. NSF 49 Field Testing Requirements for Class II Biological Safety Cabinets:

The contractor shall certify all Class II biosafety cabinets to the manufacture standards, current version of NSF/ANSI 49-2024 (or higher) specifications as well as CETA CAG 003. All equipment used to certify biological safety cabinets shall have ISO/IEC 17025 accredited calibration certification. Any unit that fails to meet specifications shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice. In addition, any failures shall be reported directly to the site point of contact (POC) as soon as practicable. All annual and quarterly on-site certifications for Biological Safety Cabinets (BSCs) must be accomplished in accordance with the most current National Sanitation Foundation/American

National Standards Institute (NSF/ANSI) Standard 49 Class II (laminar flow) Biosafety Cabinetry.

For each PEC passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information:

Company name and address Unit make, model and serial number Report number Location (room number) Certification date

Technician signature

A.3.3. PEC Testing and Certification:

The contractor shall test and certify each PEC to the most current version of The Institute of Environmental Sciences (IEST) RP CC002 (Unidirectional-flow, clean-air devices), CETA CAG

-003, and manufacturer’s specifications. The contractor shall use a NIST traceable or comparable calibrated piece of equipment to perform all testing. The contractor shall report each individual face velocity reading and the average of those readings, the downstream concentration reading of the HEPA filter leak test and the results of the induction leak test and back streaming test. All annual and quarterly on-site certifications for PECs must be accomplished in accordance with the most current standards. Any failures shall be reported directly to the identified site point of contact(s) as soon as practicable.

The list of tests includes, but is not limited to:

HEPA filter leak test Cabinet leak test Inflow velocity test to include exhaust airflow volume rate Airflow Smoke pattern test Electrical leakage and ground circuit resistance and polarity tests Lighting intensity test Vibration test Noise level test Ultraviolet (UV) lamp test

For each PEC passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information:

Company name and address Unit make, model and serial number Report number Location (room number)

Certification date

Technician name and signature

A.3.4. Viable and Non-viable Particle Counts:

For the PECs, viable and non-viable particle counts samples will be collected. Viable samples will be collected for each device (both bacterial and fungal) for the air and surface in accordance with USP <797>. Refer to the description of these tests in the section A.3.5.3 and A.3.5.4 for details.

A.3.5. USP<797> Testing for Pharmacy Clean Rooms:

The contractor will provide comprehensive cleanroom testing and certification services every 3 months for certifications to include:

HEPA filter integrity testing Airflow testing: Airflow testing is performed to determine acceptability of the air velocity, the room air exchange rate, and the room pressure differential in doorways between adjacent rooms to ensure consistent airflow and that the appropriate quality of air is maintained under dynamic operating conditions.

Total particle count testing Room pressurization monitoring Temperature and Humidity monitoring Initial Air pattern analysis Microbiological air and surface monitoring Dynamic airflow smoke pattern test for each PEC (contractor to leave video of smoke test on site prior to completion of certification process).

Written Report

Based upon findings noted in quarterly certifications, or as necessary after an environmental excursion or physical change to the spaces or PECs occurs, additional applicable re-certification tests will be completed to reassess applicable areas and are included within this contract.

A.3.5.1 Air Changes per Hour:

The contractor shall calculate the total room volume for each room. A sketch of the room with dimensions, exhaust/supply diffuser locations and equipment locations shall be included in the report. The report provided will specify flow rates detailing returns and supply that were obtained during the testing. The contractor shall calculate air changes per hour (ACPH) for each buffer and ante room and include their findings in the report. Comparison of ACPH will be completed both for USP <797> standards as well as those referenced VHA HVAC Design Manual.

In the event that a room does not meet USP<797> or VHA HVAC Design Manual requirements for ACPH the identified site POC(s) shall be informed immediately.

A.3.5.2. Pressure Requirements:

The contractor shall include in their report differential pressure readings from each buffer/ante room to all surrounding areas. The report shall indicate whether the room is required to be a negative or positive pressure room per USP<797>. All readings and acceptance criteria shall be documented to at least one thousandths of an inch water column (e.g., 0.020” w.c. and not 0.02” w.c.) or one tenth of a pascal (e.g., 2.5 Pa). Pressure differentials will be reflected on a report showing the sketch of the room(s).

A.3.5.3. Viable Environmental Sampling:

The contractor shall perform viable environmental (air and surface) sampling every 3 months for fungi and bacteria using high volume impaction samplers to conduct the sampling. While it is acceptable per USP <797> standards to utilize Tryptic Soy Agar (TSA) media for bacteria, and another media specific to fungal, RVAHCS requires all air samples to utilize TSA media which supports growth of both bacteria and fungi.

Air sampling: A sufficient volume of air (1000 liters) shall be tested at each location to maximize sensitivity. Samples of less than 1000 liters will not be acceptable.

Surface Sampling: Surface samples will be collected in each room, the interior of each ISO Class 5 PEC, equipment inside the PEC, pass through chambers connecting to classified areas, and frequently touched surfaces.

Any laboratory results equal to or greater than the action level will require notification of the POC(s) immediately upon receipt of results.

Reports to include at a minimum:

o Date and time sampling was taken.

o All Environmental sampling reports will contain both the quantitative number of bacterial/fungal isolates as well as the species grown to the genus level.

o Medial lots used for samples o Comments indicating when dynamic conditions were used o Certificates of analysis of media used o Sketch identifying location of each sample obtained

A.3.5.4. Monthly Surface Sampling, Personnel Competency Assessment, and Gloved Fingertip (GFT) and Media Fill Test (MFT):

Monthly Surface Sampling:

o For those months without a scheduled quarterly certification or environmental sampling collection, the facility shall collect surface samples for the assessment of ongoing compliance.

o Surface samples will be taken from each of the following classified areas:

■ Each room

■ Interior of Class 5 PEC

■ Equipment contained within PEC

■ Pass through chambers connecting to classified areas

■ Frequently touched surfaces o Surface sample locations and quantity will be reviewed with and verified by points of contact for each location by contractor.

o Surface samples will be collected, sent through the same laboratory used for viable environmental sampling, incubated with appropriate temperature and storage time, and analyzed all in accordance with USP <797> (or more recent) requirements.

Personnel Competency Assessment o Contractor shall offer service to complete and document assessment of competency of compounding personnel including gowning/garbing observation, Gloved Fingertip Test (GFT) and Media Fill Test (MFT), and post-test Surface Sample (SS).

■ Contractor will include materials and assessment of

GFT/MFT/SS results in accordance with USP <797> (or more recent) requirements.

■ If facility elects to complete competency assessment internally, facility will capture GFT/MFT/SS samples. Facility collected samples will be sent through contractor to same laboratory used for environmental sampling for consistency. Contractor and laboratory will ensure incubation temperatures, and storage times comply with USP <797> (or more recent) requirements.

o Report:

■ Through either contractor or facility captured GFT/MFT/SS, contractor will utilize the same laboratory used for viable environmental sampling to incubate and analyze samples.

■ Results will be reported as number of cfu per hand with notation of whether cfu action level is exceeded through reporting total number of cfu from both hands.

o Competency assessment and documentation will be in accordance with USP <797> (or more recent) requirements.

A.3.5.5. Nonviable Particle Testing:

The contractor shall perform environmental nonviable particle testing quarterly (e.g., every 3 months). The contractor shall derive the minimum number of sampling locations using Annex A in the ISO 14644-1.2 (or most recent) standard. Testing shall be performed by qualified operators using current, state-of-the-art electronic equipment with results of the following:

ISO Class 5: not more than 3520 particles 0.5 μm and larger size per cubic meter of air for any area primary engineering control (BSC or

LAFW).

ISO Class 7: not more than 352,000 particles 0.5 μm and larger size per cubic meter of air for any buffer area or hazardous compounding ante room.

ISO Class 8: not more than 3,520,000 particles 0.5 μm and larger size per cubic meter of air for any non-hazardous compounding ante room.

A.3.5.6. HEPA/ULPA Filter Replacement and Minor Repairs:

The contractor shall complete any identified HEPA/ULPA filter replacement during certification visit in instances where a need is identified, and replacement is available on site. If HEPA/ULPA filter changes must be postponed until a filter can be supplied, the contractor will install the new HEPA/ULPA filter and conduct leak testing within 2 weeks from request of the facility.

The contractor shall complete additional minor repairs associated with clean room certification and operations that are identified during certification visit, and within contractor ability to resolve which may include, but are not limited to:

PEC Chemo Decontamination PEC filter or blower replacement BSC filter or blower replacement

Repairs may include parts if agreed upon by facility prior to installation.

A.3.5.7. Report Requirements:

All of the following information should be included in the report for clean room certification in addition to any additional requirements per USP <797> (most current version). Pass/Fail notifications (in addition to actual findings) should be included on a per-test basis where applicable.

Executive summary or summary of findings Recommendations to resolve any identified discrepancies Room number and/or location Room type (e.g., oncology prep room) Date of testing Date of next required certification Standards used to test room Notes Room sketch (location of supply/exhaust diffusers, equipment, room dimensions) Total room area and volume Humidity and Temperature of each room assessed for certification Air changes per hour with assessment based both from USP <797> standards as well as those referenced within the VHA HVAC Design Manual

Pressure differential Particle Count Tests o Nonviable particle counts o Viable particle count analysis o Picture of viable particle test location in room o Number of personnel present in each PEC and SEC during total particle-count tests Environmental viable sample results Dynamic Airflow Smoke-Pattern Test Results o Smoke test video (either embedded in report, or a link to the video) o Number of personnel present in each PEC and SEC o Confirm/distinguish dynamic and static conditions if applicable

Note: All PECs shall follow report requirements for a non-USP<797> units but shall include viable and nonviable particle sampling.

A.3.5.8. Report Distribution:

The contractor will immediately notify identified points of contact with any results indicating failure. A formalized written report including all required aspects specified in this Statement of Work will be provided in a timely manner with receipt by identified points of contact no more than 14 days from certification evaluation.

All completed reports will be provided via email to Jennifer.Andrecht@va.gov, souichi.wood@va.gov, and Eric.Okazaki1@va.gov. Contractor will be notified by facility of any updates to identified points of contact list on an as needed basis.

Within the first 10 calendar days of the month prior to the quarterly certification and testing, the contractor will provide via email to Jennifer.Andrecht@va.gov, souichi.wood@va.gov, and

Eric.Okazaki1@va.gov with a schedule of pending visits for the upcoming quarter per site including scheduled dates and planned tests.

Testing Frequency:

Certification procedures defined in CETA CAG-003 shall be performed by a CETA National Board of Testing (CNBT) certified testing individual/company no less than every 3 months or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performed.

Environmental sampling (air and surface) will be completed quarterly (every 3 months), or more frequently if required to assess corrective actions associated with prior negative results. Facility captured surface samples will be completed each month between contractor captured results.

Personnel competency testing and certification will be completed on a quarterly (every 3 months) basis or more frequently if required to address remediation of GFT, MFT, SS failures.

Recertification procedures may be required in between scheduled certifications based upon certification findings which may include any applicable certification test or environmental sampling. Recertification visits will be scheduled and completed within 2 weeks of request from the facility.

STATEMENT OF WORK PART B – SUPPORTING INFORMATION

B.1. PLACE OF PERFORMANCE:

Facility Name Address Roseburg VAMC 913 NW Garden Valley Blvd., Roseburg, OR 97471 Eugene VA Health Care Center 3355 Chad Dr., Eugene, OR 97408

Specific PEC and Clean Room Information Per Site:

Roseburg VAMC:

Hood

Roseburg VAMC 1 2 3 4 Physical Location (Building #)

C200H (Building 1)

C200F (Building 1)

C200G (Building 1)

C200 (SCA)

(Building 1)

Manufacturer NuAire TBD Baker GermFree Model Number NU-813-300 TBD SG304M LFGI-4USP Serial Number 18832710031

TBD 138326 4S-15-LGu-

15450 Make CVE LAFW Class II A2 CAI

EE# 38548 TBD 49364 35824

Rooms:

Cleanroom Suite:

o Anteroom (ISO 7) o Non-Hazardous IV Prep (Buffer) Room (ISO 7) o Hazardous IV Prep (Buffer) Room (ISO 7)

Segregated Compounding Area o Non-classified area

HD Storage Room:

o Non-classified area, 12 ACPH, negative -0.03 to -0.01 w.c.

HEPA Filter Information:

Quantity:

o 4 Room supply HEPA Filters

Location(s) o Ceiling Supply Diffusers – 2 in anteroom, 1 in each IV buffer room

Test Port Status:

o Installed and functional

Eugene VA Health Care Center (HCC)

Hood Eugene VA HCC 1 Physical Location (Building #)

1E106 (Building 1)

Manufacturer NuAire Model Number NU-813-300 Serial Number 196671020520 Make CVE

EE# 45124

Rooms:

HD Storage Room:

o Non-classified area, 12 ACPH, negative -0.03 to -0.01 w.c.

HEPA Filter Information:

Quantity:

o N/A

Location(s) o N/A - SCA

Test Port Status:

o N/A - SCA

Changes to facility PEC will be communicated in a timely manner to contractor and facility costs will be adjusted accordingly based on these changes. Contractor to provide unit-based costs for services to allow for adjustments in equipment.

B.2. PERIOD OF PERFORMANCE:

Contract period is from date of award for Base +3 Option Years, (4 years Total).

Performance is to begin 15 calendar days from date of award.

B.3. SPECIAL CONSIDERATIONS:

Contractor Furnished Materials: All materials and tools required to complete the tasks required.

Additionally, all contractors staff that perform on-site testing arrive wearing non-shedding clothes.

B.4. GOVERNMENT FURNISHED EQUIPMENT:

The Government will provide all necessary personnel protective equipment (PPE) required for contractors on site.

The Government will provide oversight and verification of contractor personnel completion of donning of PPE and hand hygiene prior to testing/sampling.

The Government will, on rare occasion, provide office or meeting space to discuss test results, projects, or plans.

The Government will provide replacement HEPA filters, when applicable.

May also provide desk phone service as needed.

B.5. QUALIFICATIONS OF KEY PERSONELL:

RVAHCS is seeking a qualified contractor that meets the following specifications:

All certifications must be signed by an NSF 49 certified technician. A copy of NSF 49 certifications must be attached to the bid documentation for any technicians that will be performing work at the facility.

All cleanroom performance testing must be supervised by a technician with a CETA National Board of Testing (CNBT) certification. The technician performing the testing and certification must have a current CETA certification and must be the person physically present on site performing the work. The CETA-certified technician cannot work from a remote location. Due to the critical nature of the work being performed, the CETA-certified technician work cannot be subcontracted to another company. The prime contractor must have a full-time employee with this certification and copies of the CETA certification must be submitted with the bid package. A copy of the certification must be attached to the bid documentation for the supervisor or project manager of the team that will be performing work at the facility.

Provide AIHA accredited laboratory certification for all USP<797> viable sampling analysis. Certification must be attached with bid documentation.

Provide copy of clean room certification report for evaluation.

B.6. SECURITY REQUIREMENT:

There are no security requirements required for this work, as samples are retrieved by the vendor and a test report is received in return.

B.7. ADDITIONAL CONSIDERATIONS:

The contractor (or Representative) shall contact the facility identified POC(s) to schedule work and prior to the beginning of work. Scheduling of work will be at the direction of facility identified POC(s) to ensure services are incorporated into current facility certification cycles. The Contractor shall have intermittent access to non-public parts of the Roseburg facilities. To this end, the following measures will be complied with:

The Contractor shall check-in with the POC or his/her designee prior to arrival on station.

The Contractor shall always wear an identification badge while on station, to be obtained when checking in on station with the VA police.

A low-risk NACI background investigation is required for all contractor employees authorized into the non-public areas per VA Directive and Handbook 0710, Personnel Suitability and Security Program, and VA Directive 0735, Personal identity Verification (PIV) of Federal Employees and Contractors.

All personnel performing services under this contract shall be conducting work in non- patient care areas. The Contractor will have staff escort in areas such as the Pharmacy to prevent tampering with potential patient care, or pharmaceutical counts. A designated staff member will maintain visual contact when in the sensitive work areas to ensure contact to sensitive data or items are not permitted.

Facility POC(s) will provide the contractor with additional facility specific procedures which include: check in and check out procedures; contractor badging requirements; parking procedures; and any additional facility specific procedures. The contractor will be expected to adhere to those procedures.

Services are to be performed during the hours between 7:00 AM and 4:00 PM Pacific Standard Time (PST), Monday – Friday, except weekends and Federal Holidays. The contractor shall contact the POC or his/her designee prior to commencing any work on the premises.

Recognized Federal Holidays are as follows:

New Year’s Day Martin Luther King Jr.’s Birthday President’s Day Memorial Day Independence Day Juneteenth Day

Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day

Or any other day officially declared by the president of the United States as a non- federal working day.

Due to the workload of the pharmacy during business hours, the contractor may need to work after 4:00 PM PST to accommodate the compounding schedule at the pharmacy. Contractors that are willing to perform after-hours work should include this information in their bid documentation. If a contractor is willing to perform services after 4:00 PM PST this service must be included within the bid pricing as no extra charge. The ability to perform work after hours is not required; however, preferences will be given to contractors that offer flexible work hours.

B.8. INVOICING:

Payment will be made monthly in arrears, invoices will be prepared by the Contractor, and submitted through Tungsten Network (formerly known as OB10) http://www.tungstennetwork.com/us/en/. A properly prepared invoice shall contain:

Invoice Number and Date Contractor’s Name and Address Accurate Purchase Order Number Itemized service(s) and applicable cost:

o Supply or Service provided (i.e., PEC certification, travel costs, etc.)

o Period Supply or Service Provided o Total Amount Due

Contractor questions about the e-invoicing program (Tungsten Network), contact information is as follows:

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

Web Address: HTTP://WWW.FSC.VA.GOV/EINVOICE.ASP

The contractor will provide an electronic copy of each invoice to the identified POC(s) referenced in A.1.1.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

1.00 YR __________________ __________________

Pharmacy Hood Testing and Certification. Vendor shall perform certification testing of pharmacy room, equipment, and personnel at the Roseburg VAHCS. Testing and certification to be in compliance with the Statement Of Work and USP 797.

Contract Period: Base POP Begin: 09-01-2025 POP End: 08-31-2026 certification testing of pharmacy room, equipment, and personnel at the Eugene VA HealthCare Center. Testing and certification to be in compliance with the Statement Of Work and USP 797.

Contract Period: Base POP Begin: 09-01-2025 POP End: 08-31-2026 certification testing of pharmacy room, equipment, and personnel at the Roseburg VAHCS. Testing and certification to be in compliance with the Statement Of Work and USP 797.

Contract Period: Option 1 POP Begin: 09-01-2026 POP End: 08-31-2027 certification testing of pharmacy room, equipment, and personnel at the Eugene VA HealthCare Center. Testing and certification to be in compliance with the Statement Of Work and USP 797.

Contract Period: Option 1 POP Begin: 09-01-2026 POP End: 08-31-2027 certification testing of pharmacy room, equipment, and personnel at the Roseburg VAHCS. Testing and certification to be in compliance with the Statement Of Work and USP 797.

Contract Period: Option 2 POP Begin: 09-01-2027 POP End: 08-31-2028 certification testing of pharmacy room, equipment, and personnel at the Eugene VA HealthCare Center. Testing and certification to be in compliance with the Statement Of Work and USP 797.

Contract Period: Option 2 POP Begin: 09-01-2027 POP End: 08-31-2028 certification testing of pharmacy room, equipment, and personnel at the Roseburg VAHCS. Testing and certification to be in compliance with the Statement Of Work and USP 797.

Contract Period: Option 3 POP Begin: 09-01-2028 POP End: 08-31-2029 certification testing of pharmacy room, equipment, and personnel at the Eugene VA HealthCare Center. Testing and certification to be in compliance with the Statement Of Work and USP 797.

Contract Period: Option 3 POP Begin: 09-01-2028 POP End: 08-31-2029

GRAND TOTAL __________________

PERIOD OF PERFORMANCE COST

Base Year Option Year One (1) Option Year Two (2) Option Year Three (3)

BASE PLUS 3 CONTRACT GRAND TOTAL

SECTION C - CONTRACT CLAUSES

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

PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

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

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

and

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

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

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

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

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

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

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

(i) Name and address of the Contractor;

(ii) Invoice date and number;

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

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

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

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

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

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

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

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

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

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

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

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

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

(i) Payment.—

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

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212- 5(b) for the appropriate EFT clause.

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

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

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

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

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

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

(D) Contractor point of contact.

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

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

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

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

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

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

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

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

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

(A) The date fixed under this contract.

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

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

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

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

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

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

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

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

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

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

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

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

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

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

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

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

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

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

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

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

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

(ii) Neither the…