36C24625Q1186.docx

36C24625Q1186

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

XX

36C24625Q1186 09-22-2025 Ricardo McIntosh 757-722-9961 ext 18623 09-25-2025

4PM

EDT

Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton

VA

23667 X X 541380 $19 Million N/A X Department of Veterans Affairs Durham VAMC 508 Fulton St Durham

NC

27705 Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton

VA

23667

Department of Veterans Affairs Financial Services Center

PO BOX 149971

Austin

TX

78714-9971 512-460-5049 512-460-5221 X See CONTINUATION Page Service contract for testing and certification of U.S. Pharmaceutical Convention (USP) equipment in accordance with the statement of work.

Period of Performance:

Base Year: 10/2/2025-10/1/2026 Option Year 1: 10/2/2026-10/1/2027 Option Year 2: 10/2/2027-10/1/2028 Option Year 3: 10/2/2028-10/1/2029 Option Year 4: 10/2/2029-10/1/2030 See CONTINUATION Page X Table of Contents

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 36C246 Daniel Spaulding

Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667

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

3. INVOICES: Invoices shall be submitted 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.

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

B.2 STATEMENT OF WORK (SOW)

STATEMENT OF WORK

The Department of Veterans Affairs currently has the need for a service contract for semiannual testing and certification of U.S. Pharmaceutical Convention (USP) equipment and rooms at the Durham Veterans Affairs Health Care System (VAHCS), 508 Fulton St, Durham, NC 27705 in accordance with the terms and conditions herein.

Period of Performance: The expected period of performance is 60 Months, base plus 4 option years. The expected period of performance is 10/1/2025-9/30/2030.

Magnitude of Construction:

1. DESCRIPTION OF WORK:

Hours of Operation: Services shall be performed Monday through Friday starting at 7:30am until 4:00pm, excluding Federal holidays, and any other day specifically declared by the President of the United States. Federal holidays are available at the Federal Holiday OPM Site. For working outside the hours as defined in this contract, the vendor shall give 3-day notice to the Contracting Officer Representative so that arrangements can be provided for the employees. This notice is separate from any notices required for utility shutdown described later in this section. All work to be coordinated around an operational medical center as to minimize impact to patient care.

The contractor shall furnish all labor, material, equipment, parts, supervision, etc., necessary to test and certify USP equipment and rooms at the Durham VA Health Care System

2. STATEMENT OF WORK:

a) Certification of Primary Engineering Controls (PEC)/Hoods Contractor shall provide testing and certification of all the Durham VA Health Care System pharmacy hoods either once a year (every 12 months +/- 30 days) or twice per year (every 6 months +/- 20 days) as described in the price/cost schedule. The term “Hoods” refers to all of the following: Biosafety cabinets, chemical fume hoods and HEPA units.

b) The contractor shall also provide testing and certification of all primary engineering controls (PECs) and pharmacy compounding rooms/suites used for preparation of Compounded Sterile Preparations (CSPs). PECs include biological safety cabinets (BSCs), laminar airflow workstation (LAFW) hoods, compounding aseptic containment isolators (CACI), and compounding aseptic isolators (CAI). Testing and certification of all PECs and compounding rooms/suites will be completed in accordance with the latest version of United States Pharmacopeia (USP) Chapter 797, and USP Chapter 800 or current guidelines.

c) PECs will need to be certified biannually (2x a year) and they are not all performed on the same day, they shall be staggered for contingencies.

d) The Durham VAHCS is required to maintain all primary engineering controls (PECs) used for staff and product protection. This requirement will describe all testing and certification activities required for all PECs and Pharmacy Compounding areas. PECs are used for personnel protection and/or product protection and must be certified to industry standards to ensure they are providing the required protection. All contractors and technicians shall be required to wear and maintain personal protective equipment (PPE) as provided and directed by the local facility policies described and mandated, in VHA policy 1108.12.

e) The Durham VAHCS requires standardizing testing criteria appropriate for all PECs used pursuant to current USP Chapter and Chapter standards using Controlled Environment Testing Association (CETA) Certified National Board of Testing (CNBT) certified individuals to establish consistent PEC certification procedures using the Certification Guide for Sterile Compounding Facilities CAG-003-2006 or current guidelines. Although USP states that certification procedures “such as” those outlined CAG-003-2006 shall be performed, Veterans Affairs (VA) will be requiring that CAG-003-2006 be used in lieu of any other “such as” procedures that may exist. Testing procedures shall be maintained in compliance with all current applicable standards. CAG 001-2005 CETA Guide for the use of Compounding Aseptic Isolators in Healthcare Facilities, Revised December 8, 2008 and CAG002-2006 CETA Compounding Isolator Testing Guide Revised December 8, 2008, or current guidelines, will also be used as the applicable standard for their respective PEC.

f) The United States Pharmacopeia (USP) establishes standards for cleanroom design, environmental monitoring, and competencies for the preparation, handling, and storage of CSPs. The Joint Commission (TJC) Accreditation Manual for Home Care, effective January 13, 2018, established new 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 Draft Guidance on “Insanitary Conditions at Compounding Facilities” which was published in August 2016.

g) Certification procedures defined in CETA CAG-003-2006 shall be performed by a CETA National Board of Testing (CNBT) certified testing individual no less than every 6 months (+ or - 20 days) or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performed.

h) Primary Engineering Control Testing and Certification Biological Safety Cabinets (BSCs), CACI, CAI All certification of BSC, CAI, CACI shall comply with the latest version of NSF/ANSI Standard 49 Appendix

i) CSP PEC TESTING AND CERTIFICATION: The contractor shall test and certify each PEC according to USP and using certification procedures from the Controlled Environment Testing Association (CETA) Certification Guides for Sterile Compounding Facilities (CAG-003-2006), ANSI/NSF-49 and/or the CETA Applications Guide for the Use of Compounding Aseptic Isolators in Compounding Sterile Preparations in Healthcare Facilities (CAG-001-2005 Revised Dec. 8, 2008) and/or CETA Compounding Isolator Testing Guide (CAG-002-2006 Revised Dec. 8, 2008) or the equivalent. All PECs shall:

• be certified to meet ISO Class 5 or better

• maintain unidirectional airflow

• be supplied by HEPA filtered air

j) The list of tests, depending on CETA and manufacturer guidance for the type of PEC, includes, but is not limited to:

• Viable and non-viable particle counts

• Airflow velocity testing

• HEPA filter leak test

• Induction leak/back-streaming test

• Cabinet leak test

• In-flow velocity test to include exhaust airflow volume rate

• Surface microbial and fungal sampling

• Air microbial and fungal sampling

• Airflow Smoke pattern test under dynamic operating conditions (contractor will provide video documentation of each test to facility POCs)

k) Airflow smoke pattern testing will be completed in accordance with CAG-003-2006 for each pharmacy PEC initially and when changes are made to the PEC or room configuration. The testing will be video-recorded, and the contractor must have experience in collecting these videos. The facility will provide a minimum of one pharmacy technician to conduct simulated drug compounding in each PEC during the smoke visualization testing. The testing must show that first air conditions are achieved at the critical site during all compounding tasks within the respective PEC. This may mean that the contractor provides movement of the smoke source and/or multiple camera angles to ensure that each compounding task is effectively shown to be completed within an area receiving first air. It is important that the contractor recognize that this testing is beyond the typical scope of an equipment certification. These videos are to capture both the effective operation of the PEC and also the effective compounding techniques of the pharmacy staff. The contractor should understand that coordination with the pharmacy staff and management is imperative in collecting useful PEC smoke visualization videos as intended by CAG-003-2006.

l) Laminar Flow Hoods (Laminar Airflow Workbench (LAWF), Integrated Vertical Laminar Flow Zone (IVLFW), and Biological Safety Cabinet (BSC)) must be tested and certified according to CETA CAG-003-2006 guidelines and to manufacturer’s specifications. Horizontal laminar flow cabinets shall be certified according to The Institute of Environmental Sciences (IEST) RP-CC-002 Testing Laminar Air Flow Devices (to include Induction Leak/Backstreaming Test) and IEST-RP-CC034 HEPA Filter Leak Test. Certifications for Class II 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). The contractor shall use a National Institute of Standards and Technology (NIST) traceable or comparable calibrated piece of equipment (calibrated within past 12 months) to perform all testing and provide copies of the calibration tests to the Government Technical Representative upon request. Confirmation of this calibration shall be listed in the final certification report. 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. Any failures shall be reported directly to the identified site point of contact(s) as soon as practicable. Any unit that fails to meet required specifications shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice. Restricted access barrier system (Compounding Aseptic Isolator (CAI), Compounding Aseptic Containment Isolator (CACI), and Isolators (i.e. PECs with a controlled workspace, transfer devices, access devices, and a decontamination system) must be certified according to CETA CAG-002-2006 and CAG-003-2006 guidelines and to manufacturer’s specifications. Any unit that fails to meet required 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 identified point(s) of contact (POC) as soon as practical.

m) TESTING STANDARDS: All CSP Facilities must be tested and certified in accordance to ISO 14644-1 Classifications of Air Cleanliness, CETA CAG-03-2006 and CETA CAG-009-00 specifications. The contractor will provide comprehensive cleanroom testing and certification services with frequency required by most current USP standards and USP . Test equipment used for certification will be clean, in good working order and calibrated on a calibration frequency not to exceed 12 months or more frequently if recommended by the manufacturer. Calibration certificates should be provided upon request by the facility POC for all calibrated test equipment. USP Compliance Testing for Cleanrooms and Controlled Environment certification will include but is not limited to the following:

• Non-Viable Particle Counting under dynamic operating conditions

• Viable / Microbial and Fungal Air Testing

• Viable / Microbial and Fungal Surface Testing

• Airflow Volume Measurements

• Air Velocity Profile

• Room Air Exchange Rates

• Room Pressure Measurement (in water columns)

• In-Place Leak Testing of HEPA Filters

• Temperature, Relative Humidity Measurements

• Smoke test under dynamic conditions.

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 and . Viable microbial and fungal air and surface sampling will also be required for each room where CSPs are made.

Air Changes per Hour

The contractor shall calculate the total room volume for each buffer, ante room, and hazardous drug storage 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, ante room, segregated compounding area (SCA) and HD storage room and include their findings in the report. In the event, that a room does not meet USP or USP requirements for ACPH the identified site POC(s) shall be informed immediately.

Pressure Requirements: The contractor shall include in their report differential pressure readings from each buffer/ante room to all surrounding areas as well as the static pressure of the hazardous drug SCA. The report shall indicate whether the room is required to be a negative or positive pressure room per USP (or USP when applicable). The contractor shall report all pressures to an accuracy of 0.0001” water column (4 decimal places). Pressure differentials will be reflected on a report showing the sketch of the room(s).

Viable Environmental Sampling: The contractor shall perform viable environmental(air)sampling every 6 months for fungi and bacteria using high volume impaction samplers to conduct the sampling. ii) In addition, semi-annual viable environmental surface sampling of classified areas will be performed. This includes the hazardous and non-hazardous buffer rooms, the ante room and each segregated compounding area. When conducted surface sampling must be performed at the end of the compounding activities or shift, but before the area has been cleaned and disinfected.

• The interior of the PEC and the equipment contained in it

• Staging or work area(s) near the PEC

• Frequently touched surfaces

• Pass-through chamber(s) f) 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: The contractor shall perform surface samples for bacteria using Tryptic Soy Agar (TSA) media at 30-35 degrees Celsius for 48 hours then 20-25 degrees Celsius for 5 days. Surface sampling must be performed at the end of the compounding activities or shift, but before the area has been cleaned and disinfected.

The lab chosen to analyze the samples must be verified prior to testing and be certified. g) Nonviable Particle Testing The contractor shall perform environmental nonviable particle testing semiannually (e.g. every 6 months). The contractor shall derive the minimum number of sampling locations using Annex A in the ISO 14644-1.2 standard. Testing shall be performed by qualified operators using current, state-of-the-art electronic equipment with results per USP 797, Section 4.1.

REPORTS: The following information shall be included in the report for clean room certification. Pass/Fail notifications should be included on a per-test basis where applicable. Reports to include at a minimum:

• Environmental sampling reports will contain both the quantitative number of bacterial/fungal isolates as well as the species grown.

• The identification of highly pathogenic microorganisms will be highlighted in the report.

• Action level for ISO area tested

• Executive summary or summary of findings.

• Room number and/or location • Room type (e.g. oncology prep room)

• Type of PEC certified

• Serial number of the equipment certified

• Building Asset number of the equipment certified

• Date and time samples are collected, and particle counts tested

• Name of Technician collecting the samples

• Date of next required certification

• Standards used to test room or equipment

• Comments indicating when dynamic operating conditions were used

• Notes

• Room sketch (location of supply/exhaust diffusers, equipment, room dimensions)

• Sketch identifying location of each sample obtained

• Total room area and volume

• Room humidity and temp

• Room air changes per hour

• Pressure differentials in water columns

• Nonviable particle counts (CFU’s), action level for target ISO level

• Viable particle count analysis

• Sketch of viable particle test location in room

• Viable sample results (CFU’s), action level

• Certificates of analysis of media used

• Comments indicating when dynamic operating conditions were used.

All completed reports will be provided via email to Contracting Officers Representative. Contractor will be notified by the facility of any updates to identified points of contact list on an as needed basis.

TEST EQUIPMENT AND CONTRACTOR STANDARDS

All test equipment will be supplied by the contractor and must be calibrated within the last 12 months to an industry standard and manufacturer specifications. Calibration certification letters for equipment must be kept with the contractor technician for review by the Government Technical Representative at the time of inspection, if needed. All technicians performing the work must be qualified by education and experience. At least one technician performing the work in areas where CSP are prepared must be Controlled Environment Testing Association (CETA) certified and registered as required by VHA Directive1108.12 https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=8151). A copy of this publication can be requested from the Contracting Officers Representative.

Contractor Furnished Materials: All materials and tools to complete the work identified. ii) Contractor to ensure all staff that perform on-site testing arrive wearing non-shedding clothing. iii) All equipment will be stored and transported by the contractor in a manner that maintains cleanliness of equipment and introduces minimal micro-organisms into the clean environments being tested. All equipment will be wiped/cleaned prior to taking into clean testing environments.

Contractor Qualifications/References: All contractor performed certifications must be signed by an NSF49 certified technician. ii) All cleanroom performance testing must be supervised by a technician with a CETA National Board of Testing (CNBT) certification. The CETA-certified technician must be onsite and working within the clean room areas while testing is being conducted. Supervision or oversight from a different location is not allowed. 36C24621P0101 Page 12 of 13 III) Laboratory shall be American Industrial Hygiene Association (AIHA)accredited for all USP viable sampling analysis.

ADDITIONAL TRIP CHARGES

If additional testing, troubleshooting, adjustment or repair is required, the contractor shall provide up to 8 additional service visits each contract year. These additional site visits will only be utilized at the request of the Contracting Officers Representative. The additional site visit line item shall include all costs associated with travel, per diem, lodging, mileage, movement/shipping of equipment, overnight pay or any other costs the contractor may incur in visiting the facility outside of the normal semiannual visits. The cost must cover a site visit which may exceed a single workday (depending on the additional work required).

EQUIPMENT SCHEDULE:

2. Laminar Airflow Workbench in F1204M (s/n 214658070822)

3. Laminar Airflow Workbench in F1204M (s/n 214940071422)

4. Laminar Airflow Workbench in F1204M (s/n 216123092822)

5. Biological Safety Cabinet in F1204L (s/n 215391080122)

6. Biological Safety Cabinet in F1204L (s/n 215392080122)

7. Biological Safety Cabinet in F1204L (s/n 215393080122)

8. Compounding Aseptic Isolator in E4014 (s/n 3S-15-LGU-18533)

9. Laminar Airflow Workbench in E4014 (s/n 65-15-BH-15399)

10. Biological Safety Cabinet in N1004 (s/n 3S-15-BT-13785)

11. Laminar Airflow Workbench in ANNEX (s/n 3S-15-BVBI-19001)

12. Laminar Airflow Workbench in ANNEX (s/n 3S-15-BVBI-19002)

13. Biological Safety Cabinet in ANNEX (s/n 3S-15-BT-18914)

14. Biological Safety Cabinet in ANNEX (s/n 3S-15-BT-18915)

15. ANNEX C-Secondary Engineering Control (non-hazardous)

16. ANNEX C-Secondary Engineering Control (Hazardous Cleanroom)

17. Greenville HCC Anteroom 2C416

18. Greenville HCC Hazardous Buffer Room 2C418

19. Greenville HCC (non-Haz) SCA 1A135

20. Greenville HCC Biological Safety Cabinet (s/n 110109)

21. Greenville HCC Laminar Airflow Workbench (s/n 110117)

22. Garner (non haz) hood new equipment. Not in service and no s/n yet.

23. Garner haz hood new equipment. Not in service and no s/n yet.

24. Garner Anteroom. Not in service and no s/n yet.

EQUIPMENT SCHEDULE CONTINUED:

Location Testing Required Months Due

Non-Viable Counts F1204 Certification – Isolator (glove box) with viable and non-viable counts

Smoke Study Videos

Nonviable Particle Counts (2x)

Counts (2x)

Clean room Certification - Testing and certification of HEPA filters, non-viable particle counts, cfms and/or velocities, pressures and air changes

Smoke Study video.

N1004 Smoke Study videos.

ACPH anteroom/buffer room.

SICU A4038 Smoke Study videos.

Location Testing Required Months Due

Non-Viable Counts.

GHCC Non-Haz-1A135 Smoke Study videos.

Counts.

GHCC Haz-2C418 ACPH anteroom/buffer room

Smoke Study videos.

3. GENERAL:

Primary Engineering Control Testing and Certification Biological Safety Cabinets (BSCs), CACI, CAI All certification of BSC, CAI, CACI shall comply with the latest version of NSF/ANSI Standard 49 Appendix

a. The contractor will immediately notify the Contracting Officer Representative with any results indicating failure. The unit will be marked with signage to let the user know that the unit shall not be used and contain the contact information of the Contracting Officer Representative. Under no circumstance will repairs be accomplished by the contractor unless specifically covered under the contract. For each BSC passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information:

• Company name, address and phone number

• Unit make, model and serial number

• Report number reflecting the room certification

• Location (room number)

• Certification date

• Recertification date

b. Chemical Fume Hoods

All certification of Laboratory Chemical Fume hoods will comply with the latest version of ANSI/ASHRAE Standard 110. Face velocity testing and smoke visualization testing will be required; however, the tracer gas containment test using sulfur hexafluoride will not be required. The sash height achieving the required 100 fpm will be marked with a sticker designed for this purpose. A test report will be generated, and any comments or problems noted. Additionally, any fume hoods with face velocity monitors or controllers will be recalibrated to the correct velocity. The contractor will immediately notify the Contracting Officer Representative with any results indicating failure. The unit will be marked with signage to let the user know that the unit shall not be used and contain the contact information of the Contracting Officer Representative. For each unit passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information:

• Company name, address and phone number

• Unit make, model and serial number

• Report number reflecting the room certification

• Location (room number)

• Certification date

• Recertification date

• Sash height (only for fume hoods)

• The average recorded face velocity

• Technician signature

c. The contractor’s employees shall not enter the work site without appropriate identification. They may also be subject to inspection of their personal effects when entering or leaving the project site.

d. Site and Building Access: Maintain free and unobstructed access to facility emergency services and for fire, police and other emergency response forces in accordance with NFPA 241.

e. Means of Egress: Do not block exiting for occupied buildings, including paths from exits to roads. Minimize disruptions and coordinate with COR.

f. Buildings will be occupied during performance of work. Contractor shall take all measures and provide all material necessary for protecting existing equipment and property in affected areas against dust and debris, so that equipment and affected areas to be used in the Durham VAHCS operations will not be hindered. Coordinate alteration work in areas occupied by Department of Veterans Affairs so that Durham VAHCS operations will continue during the installation period.

g. No utility service such as water, gas, steam sewers or electricity, or fire protection systems and communications systems may be interrupted without prior approval of COR. Electrical work shall be accomplished with all affected circuits or equipment de energized. When an electrical outage cannot be accomplished, work on any energized circuits or equipment shall not commence without the Medical Center Director’s prior knowledge and written approval. The vendor shall submit a request to interrupt any such services to COR, in writing, 48-hours in advance of proposed interruption. Request shall state reason, date, exact time of, and approximate duration of such interruption.

h. The contractor shall maintain neat and orderly work areas and shall clean area of debris and rubbish daily and dispose of waste materials offsite per hospital policies. The contractor shall provide a dumpster if it is determined to be necessary and shall work with the COR in advance for a spot-on site to establish the dumpster.

i. All work shall be performed in full accordance with applicable local and Federal regulations. All materials and installation shall conform to the recommendations of National Fire Protection Association (NFPA), plumbing and mechanical codes. No departures from specification requirements will be permitted without written approval. The Supplier shall use good safety practices while working. All hardware should be installed in such a manner to minimize damage and maximize patient and employee safety.

j. New work shall be installed and connected to existing work safely and professionally. Disturbed or damaged work shall be replaced or repaired to its prior conditions.

k. All items furnished shall be free from defects that would adversely affect the performance, maintainability and appearance of individual components and overall assembly.

l. Hot Work: Perform and safeguard hot work operations in accordance with NFPA 241 and NFPA 51B. Obtain daily permits from facility Safety Manager at least 24-hours in advance.

m. Where the Government determines that the vendor has installed equipment not conveniently accessible for operation and maintenance, equipment shall be removed, and reinstalled or remedial action performed as directed at no additional cost to the Government.

n. Contractor personnel and sub-contractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA personnel regarding information and information system security.

o. If required by Infection Control, all contractor and sub-contractor personnel shall have completed tuberculosis skin test within the past year and provide documentation to the COR prior to performing any work at the VA facility. The contractor shall be issued temporary construction badges each day work is performed and must be returned at the end of each workday. All contractors shall wear badges so that the badges are easily viewed always while on-site. Contractor shall notify the COR immediately of any lost badges. Contractor and all their employees shall report to the safety office to receive safety training prior to working on site. Contractors will be issued a short-term parking pass. Contractor shall provide a valid driver’s license, license plate number and signed copy of their contract. OSHA 10-hour training is required for all workers on site and the OSHA 30-hour training is required for Trade Competent Persons (CPs) and shall provide documentation to the COR prior to performing any work at the VA facility.

End of Statement of Work

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF COMPOUNDING ASEPTIC ISOLATOR (CAI) IN ROOM F1204 (SN:6S-15-VF-17957) Contract Period: Base POP Begin: 10-02-2025 POP End: 10-01-2026 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF LAMINAR AIRFLOW WORKBENCH (LAFW) IN ROOM F1204M (SN:214658070822)

POP Begin: 10-02-2025 POP End: 10-01-2026

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF LAMINAR AIRFLOW WORKBENCH (LAFW) IN ROOM F1204M (SN:214940071422)

POP Begin: 10-02-2025 POP End: 10-01-2026

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF LAMINAR AIRFLOW WORKBENCH (LAFW) IN ROOM F1204M (SN:216123092822)

POP Begin: 10-02-2025 POP End: 10-01-2026

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF BIOLOGICAL SAFETY CABINET (BSC) IN ROOM F1204L ( SN:215391080122)

POP Begin: 10-02-2025 POP End: 10-01-2026

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF BIOLOGICAL SAFETY CABINET (BSC) IN ROOM F1204L ( SN:215391080122)

POP Begin: 10-02-2025 POP End: 10-01-2026

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF BIOLOGICAL SAFETY CABINET (BSC) IN ROOM F1204L ( SN:215391080122)

POP Begin: 10-02-2025 POP End: 10-01-2026

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF COMPOUNDING ASEPTIC IOSLATOR (CAI)IN SICU (SN:3S-LGU-18533)

POP Begin: 10-02-2025 POP End: 10-01-2026

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF BIOLOGICAL SAFETY CABINET (BSC) IN ROOM N1004 (SN:3S-15-BT-13785)

POP Begin: 10-02-2025 POP End: 10-01-2026

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF LAMINAR AIRFLOW WORKBENCH (LAFW) IN ANNEX (SN:3S-15-BVB1-19001)

POP Begin: 10-02-2025 POP End: 10-01-2026

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF LAMINAR AIRFLOW WORKBENCH (LAFW) IN ANNEX (SN:3S-15-BVB1-19002)

POP Begin: 10-02-2025 POP End: 10-01-2026

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF BIOOGICAL SAFETY CABINET (BCS) IN "ANNEX" (SN:3S-15-BR2-18914)

POP Begin: 10-02-2025 POP End: 10-01-2026

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF BIOOGICAL SAFETY CABINET (BCS) IN "ANNEX" (SN:3S-15-BR2-18915)

POP Begin: 10-02-2025 POP End: 10-01-2026

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION ANNEX SEC (NON HAZ)

POP Begin: 10-02-2025 POP End: 10-01-2026

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION ANNEX C-SEC (HAZ CLEANROOM)

POP Begin: 10-02-2025 POP End: 10-01-2026

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

GREENVILLE HCC ANTE-ROOM 2C416

POP Begin: 10-02-2025 POP End: 10-01-2026

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

GREENVILLE HCC HAZARDOUS BUFFER ROOM 2C418

POP Begin: 10-02-2025 POP End: 10-01-2026

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

GREENVILLE HCC BIOLOGICAL SAFETY CABINET (S/N 110109)

POP Begin: 10-02-2025 POP End: 10-01-2026

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

GARNER SEMI-ANNUAL INSPECTION AND CERTIFICATION (NON HAZ)

POP Begin: 10-02-2025 POP End: 10-01-2026

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

GARNER SEMI-ANNUAL INSPECTION AND CERTIFICATION (HAZ CLEANROOM)

POP Begin: 10-02-2025 POP End: 10-01-2026

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

ADDITIONAL TRIP CHARGES

POP Begin: 10-02-2025 POP End: 10-01-2026

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF COMPOUNDING ASEPTIC ISOLATOR (CAI) IN ROOM F1204 (SN:6S-15-VF-17957)

POP Begin: 10-02-2026 POP End: 10-01-2027

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF LAMINAR AIRFLOW WORKBENCH (LAFW) IN ROOM F1204M (SN:214658070822)

POP Begin: 10-02-2026 POP End: 10-01-2027

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF LAMINAR AIRFLOW WORKBENCH (LAFW) IN ROOM F1204M (SN:214940071422)

POP Begin: 10-02-2026 POP End: 10-01-2027

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF LAMINAR AIRFLOW WORKBENCH (LAFW) IN ROOM F1204M (SN:216123092822)

POP Begin: 10-02-2026 POP End: 10-01-2027

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF BIOLOGICAL SAFETY CABINET (BSC) IN ROOM F1204L ( SN:215391080122)

POP Begin: 10-02-2026 POP End: 10-01-2027

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF BIOLOGICAL SAFETY CABINET (BSC) IN ROOM F1204L ( SN:215391080122)

POP Begin: 10-02-2026 POP End: 10-01-2027

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF BIOLOGICAL SAFETY CABINET (BSC) IN ROOM F1204L ( SN:215391080122)

POP Begin: 10-02-2026 POP End: 10-01-2027

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF COMPOUNDING ASEPTIC IOSLATOR (CAI)IN SICU (SN:3S-LGU-18533)

POP Begin: 10-02-2026 POP End: 10-01-2027

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF BIOLOGICAL SAFETY CABINET (BSC) IN ROOM N1004 (SN:3S-15-BT-13785)

POP Begin: 10-02-2026 POP End: 10-01-2027

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF LAMINAR AIRFLOW WORKBENCH (LAFW) IN ANNEX (SN:3S-15-BVB1-19001)

POP Begin: 10-02-2026 POP End: 10-01-2027

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF LAMINAR AIRFLOW WORKBENCH (LAFW) IN ANNEX (SN:3S-15-BVB1-19002)

POP Begin: 10-02-2026 POP End: 10-01-2027

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF BIOOGICAL SAFETY CABINET (BCS) IN "ANNEX" (SN:3S-15-BR2-18914)

POP Begin: 10-02-2026 POP End: 10-01-2027

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF BIOOGICAL SAFETY CABINET (BCS) IN "ANNEX" (SN:3S-15-BR2-18915)

POP Begin: 10-02-2026 POP End: 10-01-2027

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION ANNEX SEC (NON HAZ)

POP Begin: 10-02-2026 POP End: 10-01-2027

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION ANNEX C-SEC (HAZ CLEANROOM)

POP Begin: 10-02-2026 POP End: 10-01-2027

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

GREENVILLE HCC ANTE-ROOM 2C416

POP Begin: 10-02-2026 POP End: 10-01-2027

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

GREENVILLE HCC HAZARDOUS BUFFER ROOM 2C418

POP Begin: 10-02-2026 POP End: 10-01-2027

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

GREENVILLE HCC BIOLOGICAL SAFETY CABINET (S/N 110109)

POP Begin: 10-02-2026 POP End: 10-01-2027

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

GARNER SEMI-ANNUAL INSPECTION AND CERTIFICATION (NON HAZ)

POP Begin: 10-02-2026 POP End: 10-01-2027

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

GARNER SEMI-ANNUAL INSPECTION AND CERTIFICATION (HAZ CLEANROOM)

POP Begin: 10-02-2026 POP End: 10-01-2027

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

ADDITIONAL TRIP CHARGES

POP Begin: 10-02-2026 POP End: 10-01-2027

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF COMPOUNDING ASEPTIC ISOLATOR (CAI) IN ROOM F1204 (SN:6S-15-VF-17957)

POP Begin: 10-02-2027 POP End: 10-01-2028

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF LAMINAR AIRFLOW WORKBENCH (LAFW) IN ROOM F1204M (SN:214658070822)

POP Begin: 10-02-2027 POP End: 10-01-2028

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF LAMINAR AIRFLOW WORKBENCH (LAFW) IN ROOM F1204M (SN:214940071422)

POP Begin: 10-02-2027 POP End: 10-01-2028

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF LAMINAR AIRFLOW WORKBENCH (LAFW) IN ROOM F1204M (SN:216123092822)

POP Begin: 10-02-2027 POP End: 10-01-2028

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF BIOLOGICAL SAFETY CABINET (BSC) IN ROOM F1204L ( SN:215391080122)

POP Begin: 10-02-2027 POP End: 10-01-2028

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF BIOLOGICAL SAFETY CABINET (BSC) IN ROOM F1204L ( SN:215391080122)

POP Begin: 10-02-2027 POP End: 10-01-2028

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF BIOLOGICAL SAFETY CABINET (BSC) IN ROOM F1204L ( SN:215391080122)

POP Begin: 10-02-2027 POP End: 10-01-2028

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF COMPOUNDING ASEPTIC IOSLATOR (CAI)IN SICU (SN:3S-LGU-18533)

POP Begin: 10-02-2027 POP End: 10-01-2028

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF BIOLOGICAL SAFETY CABINET (BSC) IN ROOM N1004 (SN:3S-15-BT-13785)

POP Begin: 10-02-2027 POP End: 10-01-2028

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF LAMINAR AIRFLOW WORKBENCH (LAFW) IN ANNEX (SN:3S-15-BVB1-19001)

POP Begin: 10-02-2027 POP End: 10-01-2028

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND CERTIFICATION OF LAMINAR AIRFLOW WORKBENCH (LAFW) IN ANNEX (SN:3S-15-BVB1-19002)

POP Begin: 10-02-2027 POP End: 10-01-2028

PRODUCT/SERVICE CODE: H966 - Other Quality Control, Testing, and Inspection - Instruments and Laboratory Equipment

SEMI-ANNUAL INSPECTION AND…