36C24226Q0030_1.docx

36C24226Q0030

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

36C24226Q0030 10-17-2025

HARRIS, LISA

Lisa.Harris4@va.gov 10-28-2025 14:00

EDT

Department of Veterans Affairs 400 Fort Hill Ave.

Canandaigua

NY

14424 X 541380 $19 Million N/A X Department of Veterans Affairs Northport VAMC 79 Middleville Road Northport, NY 11768

Department of Veterans Affairs Network Contracting Activity 400 Fort Hill Ave.

Canandaigua

NY

14424

Tungsten Network https://www.tungsten-network.com/ customer-campaigns/veteransaffairs/

See CONTINUATION Page Testing of sterile compounding areas at the Northport VAMC specified in the Statement of Work (SOW) included herewith.

Site Visit is scheduled for October 22, 2025 at 11:00 am.

RSVP by October 21, 2025 at 10:00 am to Lisa.Harris4@va.gov to confirm attendance and receive location details.

Questions are due October 23, 2025 at 10:00 am to Lisa.Harris4@va.gov.

See CONTINUATION Page X X X One(1) Lisa Harris Contract Officer 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 36C242 Lisa Harris

Department of Veterans Affairs 400 Fort Hill Ave.

Canandaigua NY 14424

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.

https://www.tungsten-network.com/customer-campaigns/veteransaffairs/

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

36C24226Q0030

Page 1 of Page 1 of

B.2 STATEMENT OF WORK

STATEMENT OF WORK

Testing of Sterile Compounding Areas

1. INTRODUCTION

a. United States Pharmacopeia (USP) establishes standards for cleanroom design, environmental monitoring, and competencies for the preparation, handling, and storage of compounded sterile preparations (CSPs). To maintain compliance with these standards, Northport VAMC requires a Base plus four (4) year contract inclusive of all labor, materials, equipment, and travel (within 2 hours) to perform initial and recurring certification of the facility’s sterile compounding areas. Certification and testing will consist of:

i. testing all primary engineering controls (PECs) e.g., biological safety cabinets (BSCs), laminar airflow hoods (LAFHs), compounding aseptic containment isolators (CACI), and compounding aseptic isolators (CAI)].

ii. testing all secondary engineering controls (SECs), non-ISO rated controlled non-classified (CNC) rooms, and High-efficiency particulate air (HEPA) filtration devices.

iii. microbiological laboratory testing of collected viables samples.

iv. wipe sampling for environmental Hazardous Drug (HD) residue.

b. Testing and certification must be completed in accordance with the most currently published versions of USP Chapter <797>, USP Chapter <800>, Controlled Environment Testing Association (CETA) Application Guides for: CAG-003 Certification of Sterile Compounding Facilities for USP Compliance, CAG-002 Compounding Isolator Testing, CAG-008 Certification Matrix for Sterile & Nonsterile USP Compounding Facilities, CAG-009 Viable Environmental Monitoring for Sterile Compounding Facilities, CAG-014 Airflow Visualization Study, National Sanitation Foundation/American National Standards Institute (NSF/ANSI) Standard 49 Biosafety Cabinetry, and Institute of Flow Clean Air Devices, IEST-RP-CC-002.4. All lab analysis of viable samples must be performed by a facility with ISO/IEC 17025 accreditation for microbial analysis. This environmental quality testing may not be performed under the laboratory’s Clinical Laboratory Improvement Amendments (CLIA) license. The lab must attain ISO/IEC 17025 certification from an external accrediting body (e.g., American Association for Laboratory Accreditation) to ensure quality and accuracy of the testing. * Note – all testing and certifications must be in accordance with most recently published versions during the life of the contract.

2. BACKGROUND.

a. Northport VAMC is pursuing a facility contract for certification of all PECs, SECs, CNC rooms, and HEPA filters performed pursuant to the most current version of USP Chapter <797> and USP Chapter <800> standards while following specific standardized testing documented in CETA CAG-008 “Certification Matrix for Sterile & Nonsterile USP Compounding Facilities.” Specific CETA testing procedures to be followed include (but are not limited to)

i. CAG-003 Certification Guide for Sterile Compounding Facilities for USP Compliance,

ii. CAG-002 CETA Compounding Isolator Testing Guide

iii. CAG-014 Airflow Visualization Study

iv. CAG-009 Viable Environmental Monitoring for Sterile Compounding Facilities

v. CAG-013 Media Fill Testing for Sterile Compounding Personnel.

b. Certification must be performed initially and repeated every 6 months. Recertification will be required after any servicing of facilities or equipment, post changes to the area that could affect airflow or air quality (e.g., redesign, construction, replacement or relocation of any PEC, or alteration in the configuration of the room), and/or in response to identified problems or trends.

c. Certification procedures defined in relevant CETA Application Guides must be performed no less than every 6 months by an individual who has the required CETA competencies and training related to the certification of primary and secondary engineering controls. Additionally, it is preferred that the on-site certification individual have received NSF accreditation for the field certification of Class II Biosafety Cabinets and are accredited through CNBT as a registered certification professional in the sterile compounding facility (RCP-SCF). Prior to testing, the contractor’s technician(s) who conduct on-site certification will provide, to the COR, documentation of competency and training related to the certification of PECs and SECs.

d. Procedures for air and surface sampling and evaluation must be compliant as per the most current USP Chapter 797 requirements for environmental air sampling, surface sampling (CAG-009), gloved fingertip testing (CAG-011), and media fill testing (CAG-013) following the appropriate CETA CAG application guide.

e. Northport VAMC’s sterile compounding areas and equipment must be compliant to The Joint Commission (TJC) and Food and Drug Administration (FDA) requirements. TJC Medication Compounding Requirements for Critical Access Hospitals and Hospitals, effective January 1, 2024, established new Medication Compounding (MC) standards for non-sterile and sterile compounded preparations which are based on USP standards. The FDA has the authority to inspect VA medical facilities under the Food, Drug and Cosmetic Act, and evaluate based upon the guidance provided in the Insanitary Conditions at Compounding Facilities Guidance for Industry, November 2020 (or most current version).

3. SCOPE

a. Testing Frequency.

i. For compliance, the Northport VAMC requires initial and recurring onsite testing as per USP Chapter 797 and Chapter 800 requirements. CETA testing procedures (including viable environmental sampling followed by lab analysis). Testing will be performed within the facility’s Pharmacy-specific and non-Pharmacy specific areas and equipment as detailed within this Statement of Work (SOW). Testing and certification dates contained within this SOW are best documented; Contractor shall be responsible to confirm and/or adjust certification/testing requirements to ensure no lapse in requirements and thus no undesirable effect on the mission of the Northport VAMC.

ii. All pharmacy-specific equipment will minimally obtain CETA certification every six (6) calendar months from the date of the last certification/testing of BSCs, LAFHs, CAI, CACI, HEPA filters, and room spaces/environments in accordance with VHA Directive 1108.12 (see attachment A), and USP 797 (Attachment B) & 800 (Attachment C). Recertification may be required sooner if equipment is relocated/altered, or a major service is performed.

iii. The Northport VAMC COR must be provided with notification at least two (2) prior to scheduled testing to allow the coordination of the facility’s workflow relocation to a contingency location. As per the facility’s policy the primary compounding locations and the contingency locations will be tested on separate dates during normal business hours. This practice of staggering testing dates between the primary locations and contingency locations will minimally require four site visits each year. The currently established CETA testing of equipment and biannual viable air and surface sampling schedule is as follows:

1. January and July- Building 200, Inpatient Pharmacy CAI, New Pavillion 2F C-SCA, CACI, & HD Storage room

2. March and September- Unit 31 Non-HD Cleanroom suite

3. TBD – Building 11 C-SCA, CACI, & HD Storage room

iv. On a monthly basis, for sample analysis, the facility will provide the lab

1. Twenty (20) surface samples collected from ISO rated locations

2. Twenty (20) surface samples collected during personnel competency assessment

3. Twenty vials collected during media fill testing simulation for competency assessment. On a monthly average four (4) employees tested using MFT kits containing five (5) vials/kit/employee testing

v. On a biannual basis (during the months of April and October), the facility will collect fourteen (14) HD wipe samples for lab analysis of trace contamination of seven (7) HDs.

b. Testing Locations. The following location shall be tested per the most up to date standards USP 797 and where applicable USP 800 standards as per respective CETA guide applications. Locations may be amended as per the facility’s renovations and construction.

i. Building 200, Unit 31 Cleanroom suite(s) Primary Space(s) and equipment

1. ISO-8 Anteroom(s): Two ceiling mounted HEPA filters

2. ISO-7 Buffer room(s)

a. Two ceiling mounted HEPA filters

b. One ISO-5 LAWF: Baker Edgegard 5252 LAWF

ii. Building 200, Inpatient: One ISO-5 Compounding Aseptic Isolator (CAI): Baker SS-500

iii. Building 200, New pavilion 2F, E2-49

1. HD negative pressure storage room: One ceiling mounted HEPA filter

2. CNC HD negative pressure C-SCA

a. One ceiling mounted HEPA filter

b. One ISO-5 HD negative pressure Compounding Aseptic Containment Isolator (CACI): Baker CS-500

iv. Building 11, 11-239C and 11-239D (Currently in the preliminary construction phase)

1. HD negative pressure storage room: Ceiling mounted HEPA filter

2. CNC HD negative pressure C-SCA

a. Ceiling mounted HEPA filter

b. One ISO-5 HD negative pressure Compounding Aseptic Containment Isolator (CACI): Baker CS-500

c. Testing Requirements of PECs.

i. Biological safety cabinet (BSC): On-site certifications of the BSCs shall be tested to manufacturer specifications in accordance with the most recent version of NSF/ANSI Standard 49 Biosafety Cabinetry (as per CETA CAG-003:2022 section 8.2. through 8.2.5 application guide and CETA CAG-005:2007 (or most current versions)

ii. Compounding Aseptic Isolator (CAI) and Compounding Aseptic Containment Isolator (CACI): The contractor shall test and certify all CAIs and CACIs as per CETA CAG-003 sections 8.3 through 8.3.5 and in accordance with CETA CAG-002 guide application.

iii. Laminar Air Flow Hood (LAFH): The contractor shall test and certify all LAFH as per CETA CAG-003:2022 section 8.4. through 8.4.6 application guide (or most current version)

iv. The contractor shall test and certify all PECs in accordance with the most current version of The Institute of Environmental Sciences and Technology (IEST)-RP-CC002 (Unidirectional Flow Clean-Air Devices), CETA CAG-003, and the manufacturer's specifications.

v. The contractor shall record 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

vi. All equipment used to certify PECs must be calibrated in accordance with IEST-RP-CC013 or manufacturer's recommendation and be NIST traceable where possible.

vii. Where applicable the list of tests for PECs includes, where applicable but not limited to the following:

1. Air flow velocity profile

2. Air flow visualization profile: dynamic smoke pattern testing (video recorded and provided to us on a thumb drive or made available for download on a secure website) for all primary engineering controls. Tester must utilize sufficient smoke to demonstrate unidirectional airflow at critical sites and sweeping action over and away from preparations.

3. Prefilter check

4. HEPA/ULPA filter leak integrity testing (must be performed upon installation and as part of certification)

5. Induction leak integrity test and patching if necessary

6. Electrical leakage and ground circuit resistance and polarity tests

7. Preparation ingress and egress test where applicable

8. Chamber pressure test

9. Total airborne non-viable particle count testing in all classified areas performed under dynamic operating conditions

viii. For each PEC passing the required certification tests, the contractor supplies each unit with a certification tag or sticker displaying the following information:

1. Company name and contact information.

2. Unit make, model and serial number.

3. Report number

4. Location (e.g., building, room number, area identification)

5. Certification date

6. Recertification date

7. Technician name and signature

ix. Any PEC that fails to meet CETA specifications shall be clearly marked with signage which alerts compounding personnel that the unit is “out of order until further notice.”

d. Testing Requirements of SECs.

i. The contractor will provide comprehensive cleanroom testing and certification services every 6 months, in the event of an environmental or engineering control excursion/exceedance or sooner if there are changes to the area such as redesign, construction, replacement or relocation of any PEC, or alteration in the configuration of the room that could affect airflow or air quality or if a cleanroom(s) did not meet compliance. Certification tests for rooms within a cleanroom suite include, but are not limited to:

1. Airflow testing: HEPA filter(s) air volumes and velocities will be measured and documented as per CETA CAG-003:2022 section 8.1.1 application guide (or most current version)

a. 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.

i. The contractor shall calculate the total room area and volume for each buffer room, anteroom, Containment segregated compounding area (C-SCA), and hazardous drug storage room. The ISO classification and 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 anteroom and include their findings in the report. ACPH for HVAC, ACPH contributed from PEC, and the total ACPH. Comparison of ACPH will be completed both for USP 797 standards as well as those referenced in the VHA HVAC Design Manual (Attachment D or earlier version if available), which are further stringent than USP Chapter 797.

ii. ISO Classified Turbulent Airflow Area Reporting and Documentation

1. Record all airflow measurements and their corresponding filter or diffuser locations or grid identifications on a diagram

2. Calculate and report room volume

3. Calculate and report the average total room airflow volume

4. Calculate and report the total air changes per hour of the room (include LAFH and/or Non-ducted BSC HEPA exhaust to room, where applicable)

5. Report any correction factors used or deviations from the primary method

6. Name of test (e.g., Room Airflow Analysis)

7. Report acceptance criteria

8. Provide a Pass or Fail statement based on the results of the test

iii. Non-ISO Classified Negative Pressure Turbulent Airflow Area Testing Procedure including ACPH requirements for containment segregated compounding areas and hazardous drug storage areas, must be a minimum of 12 exhaust ACPH. Because these rooms/areas are not ISO classified airflow measurements should be taken on the exhaust of negative pressure differential rooms. Non-ISO Classified Negative Pressure Turbulent Airflow Reporting and Documentation must include:

1. Record all airflow measurements and their corresponding exhaust filter or exhaust grill locations

2. Calculate and report room volume

3. Calculate and report the average total room airflow volume

4. Calculate and report the total air changes per hour of the room

5. Report any correction factors used or deviations from the primary method

6. Name of test (e.g., Unclassified Negative Pressure Room Airflow Analysis)

7. Report acceptance criteria

8. Provide a Pass or Fail statement based on the results of the test

2. SEC HEPA filter integrity testing performed as per CETA CAG-003:2022 section 8.1.2 application guide (or most current version)

a. Record upstream aerosol challenge concentration

b. List method used to report concentration (measured or calculated)

c. Record maximum leak penetration in percent

d. Name of test (HEPA Filter Leak Test)

e. Report acceptance criteria

f. Provide a Pass or Fail statement based on the results of the test

3. SEC Room Pressure Differential/Room Pressurization as per CETA CAG-003:2022 section 8.1.3 application guide (or most current version)

a. The contractor shall include in their report differential pressure readings from each buffer room, anteroom, C-SCA, and Hazardous Drug (HD) storage rooms to all surrounding areas.

b. The report shall indicate whether the area is required to be a negative or positive pressure location as per USP 797 and/or USP 800. All readings and acceptance criteria shall be documented to at least one thousandths of an inch water gauge or water column (e.g., 0.020” w.g. and not 0.02” w.g.) or one tenth of a pascal (e.g., 5.0 Pa). Pressure differentials will be reflected on a report showing the sketch of the room(s).

c. SEC Room Pressure Reporting and Documentation

i. Report room pressure differential relative to an adjacent room/space

ii. Report and compare performance of room pressure monitor

iii. Report whether smoke dispersed at entry doors follows correct direction

iv. Name of test (Room Pressure Differential Test)

v. Report acceptance criteria

vi. Provide a Pass or Fail statement based on the results of the test

4. Total airborne particle count testing (0.5 micron and larger) in all classified areas performed under dynamic operating conditions as per CETA CAG-003:2022 section 8.1.5 application guide (or most current version). Reporting shall be completed following ISO 14644-01 [2015] section 5.4 “Test report” and shall include the following:

a. The name and address of the testing organization, and the date on which the test was performed

b. The number and year of publication of this part of ISO 14644 (i.e., ISO 14644 1:2015)

c. A clear identification of the physical location of the cleanroom or clean zone testing (including reference to adjacent areas if necessary), and specific designations for coordinates of all sampling locations (a diagrammatic representation can be helpful)

d. The specified designation criteria for the cleanroom or clean zone, including the ISO Class number, the relevant occupancy state(s), and the considered particle size(s)

e. Details of the test method used, with any special conditions relating to the test, or departures from the test method, and identification of the test instrument and its current calibration certificate

f. The test results, including particle concentration data for all sampling locations

g. Report acceptance criteria

h. Provide a Pass or Fail statement based on the results of the test

5. SEC Airflow Visualization Studies (AVS) - Visual Smoke Studies per CETA CAG-014 guide application. 2F C-SCA room does not have wall air returns as exhaust is solely performed via the hood. This test may need to be performed.

6. SEC General Temperature and Moisture Tests to verify accuracy of monitoring devices as per CETA CAG-003:2022 section 8.1.7 application guide (or most current version)

7. SEC Viable Sampling as per CETA CAG-003:2022 section 8.1.6 and CAG-009:2020 application guides

e. Viable Sampling Testing All viable sampling will conform to USP 797 requirements and performed as per CETA CAG-009 application guide Viable Environmental Monitoring for Sterile Compounding Facilities

i. Environmental Air Sampling.

1. Biannually (every six months) the collection of environmental air samples will be performed by the contractor’s CETA technician during certification and during negatively impactful incidents which require repeat air sampling as follows:

a. whenever there is a change to the placement of equipment in the room or any other alteration within the cleanroom suite that affects the quality of the air.

b. in response to identified problems and trends.

c. in response to changes that could impact the sterile environment (changes in cleaning agents).

2. Viable air sampling will be performed utilizing a calibrated high-volume impaction sampler during dynamic operating conditions

3. Single plate TSA media which supports growth of both bacteria and fungi will be used to sample. 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)

4. Positive and negative control plates will be included with sampled plates submitted by the contractor for analysis.

ii. Environmental Surface Sampling.

1. Biannually (every six months) the collection of environmental surface samples will be performed by the contractor’s CETA technician and during repeated CETA testing. Upon the request of the facility, the contractor will repeat surface sampling as follows:

a. whenever, there is a change to the placement of equipment in the room or any other alteration within the cleanroom suite that affects the quality of the air.

b. in response to identified problems and trends.

c. in response to changes that could impact the sterile environment (changes in cleaning agents).

2. Surface samples will be collected in each room, the interior of each PEC, passthrough chambers connecting to classified areas (note: future renovated Unit 31 IV room will have two (2) passthroughs), and frequently touched surfaces (e.g., door, tables, carts, stools, benches, etc.)

3. Surface sampling will be performed at the end of the largest CSP activity of the day but before area has been cleaned and disinfected.

4. Single plate TSA media supplemented with neutralizing additives (e.g., lecithin and polysorbate 80) to neutralize the effects of any residual disinfecting agents will be used.

5. Routine monthly surface sampling will be performed by an appointed trained Northport VAMC personnel. The collected samples will be shipped to the laboratory service employed by the contractor for incubation and microbiological analysis.

6. As needed, appointed trained Northport VAMC personnel will collect surface samples within the PEC as a part of the competency assessment for assigned personnel. The collected samples will be shipped to the laboratory service employed by the contractor for incubation and microbiological analysis.

iii. Personnel Viable Sampling.

1. The collection of personnel viable samples for competency testing will be performed by an appointed trained Northport VAMC personnel. The samples will be shipped to the laboratory service employed by the contractor for incubation and microbiological analysis when it is required for personnel competency assessment sampling as follows:

a. Gloved Fingertip and Thumb (GFT) Testing of approximately 20 employees:

i. Upon initial assignment compounding staff will be assessed, post hand hygiene and garbing, utilizing GFT samples in triplicate (three samples/hand) for analysis.

ii. Every six (6) months and thereafter compounding staff will be assessed, post hand hygiene and garbing, utilizing single collection of GFT samples (one sample/hand) will be collected for analysis post hand hygiene and garbing.

iii. Initially and every six (6) months thereafter compounding staff will be assessed for GFT during aseptic manipulations, utilizing single collection of GFT samples (one sample/hand) post media fill testing (MFT). (160 gft, 40 final surface samples and 40 MFT kits per year)

b. Media Fill Test (MFT)

i. Upon initial assignment and every six months thereafter, compounding staff will be assessed for aseptic manipulations utilizing USP 797 compliant media fill testing kits.

iv. Other Viable Sampling Requirements.

1. The laboratory service employed by the contractor must be able to provide the following:

a. Microbial growth media plates which are USP 797 compliant and

i. include certificates of analysis (COA) from the manufacturer that verify the plates meet the expected growth promotion, pH, and sterilization requirements consistent with USP Chapter 797

ii. contain TSA supplemented with neutralizing additives (lecithin and polysorbate 80)

iii. have a raised convex surface

iv. support both bacterial and fungal growth on the same plate for single media incubation

b. Media fill testing (MFT) kits compliant to USP 797 and designed to

i. simulate medium complexity (Category 2) sterile IV compounding.

ii. simulate low complexity (Category 1) sterile IV compounding.

c. A chain of custody documenting each sample collected must be created and provided to the Northport VAMC.

2. During self-sampling, which is performed by Northport VAMC, the contracted lab is responsible for providing a prepaid mailer for properly sending samples to the laboratory for testing.

3. All samples shipped to the laboratory service must be incubated in accordance with current USP Chapter 797 requirements for duration and temperature. *Note: With control plates, the monthly samples total shall be 40 surface sample plates and 20 media fill testing vials.

f. Additional Requirements for PECs and/or SECs Testing

i. Any PEC or SEC that fails to meet CETA specifications shall be immediately reported directly to the site-identified point(s) of contact (POC) or appointed ad hoc.

ii. Areas where hazardous drug handling occurs will be tested by Environmental Wipe Sampling for Hazardous Drug (HD) Residue:

1. Every 6 months, or more frequently as needed to verify contaminant, environmental wipe sampling for HD residue will be performed by an appointed trained Northport VAMC personnel. The collected samples will be shipped to the contractor’s laboratory service for HD residue analysis. The kits used to complete HD wipe sampling must be verified prior to use to ensure the sensitivity and validity of the methods and reagents used to recover a specific percentage of known marker drugs.

2. The hazardous drugs (HDs) to be tested will be determined by the facility and may include, but are not limited to:

a. Cyclophosphamide

b. Ifosfamide

c. Fluorouracil

d. Gemcitabine

e. Methotrexate

f. Platinum-containing drugs

g. Taxane-based drugs

3. On average 14 surface environmental HD wipe samples will be collected per testing date. The facility can elect to adjust the quantities of samples submitted as needed during investigative remediation. Routine environmental HD wipe sampling will include, at minimum, the following areas:

a. Interior of containment primary engineering control (C-PEC) and any equipment contained inside the C-PEC.

b. Pass-through chambers.

c. Surfaces in staging or work areas near C-PEC.

d. Areas adjacent to C-PECs (e.g., floors directly under C-PEC, staging, and dispensing area).

e. Areas immediately outside the hazardous drug buffer room or C-SCA.

f. Areas designated for pharmacist end product verification (checking) / workstations.

g. Hazardous drug storage areas (including refrigerators).

h. Hazardous drug receiving areas.

i. Patient administration areas.

g. Competency of Technician Performing Testing

i. CETA testing must be performed by a CNBT individual/company accredited to perform this work. A copy of the Technician’s CETA certificate shall be provided to the facility five (s) business days prior to performance of testing for approval by the Contracting Officers Representative (COR).

ii. To ensure accurate and reproducible sampling results, environmental viable sampling should be performed by a CETA CNBT technician or a trained technician competent in air and surface sampling procedures. Prior to sampling the contractor must provide the facility documentation records for the individuals training and competencies to perform sampling.

h. Additional Contracting Requirements

i. Certification periodicities shall be confirmed by contractor, post award, and adjusted as necessary to meet the needs of the Northport VAMC.

ii. Certification and testing shall conform to the most current USP and OSHA standards.

iii. Technician will disinfect and sanitize all equipment brought into the cleanroom suite or segregated compounding area prior to entry (with PreEmpt® or Peridox® (or facility approved disinfectant cleaner), followed by sterile 70% isopropyl alcohol or as per current standard operating procedure for the cleanroom suite).

iv. Contractor will follow Northport VAMC’s protocols for use of PPE in the classified spaces and understands the risks associated with facilities and equipment designed for storage and preparation of hazardous drugs.

v. The contractor shall comply with Federal, State, and Local Laws, plus and federal regulations as applicable to the performance of this contract; to include USP Chapter 797 and USP Chapter 800. Contractor must obtain all necessary licenses and/or permits required to perform the work herein.

i. Reporting Results for CETA Testing (including Viable Sampling)

i. A “General Report Documentation” for all CETA test results must be provided via email directly to the COR (Contracting Officer Representative), Chief of Facility Management Services, Chief of Pharmacy Service, and to the Designated Compounding Pharmacist no later than seven (7) calendar days after the testing is performed. The CETA report will be a comprehensive informative report of the certification process which will include a statement of compliance or non-compliance regarding the requirements and guidelines outlined respective to CETA Application Guide. As per VHA directive 1108.12 all vendors conducting primary and secondary engineering control certifications must employ at least one CNBT Registered Certified Professional (RCP) for Sterile Compounding Facility (SCF) who will review and sign the final certification report; this can be instead of the CIH, but the CIH cannot be the only reviewer. The formal report will include as a minimum, but not limited to, the following items:

1. Name, address, and contact information for the certifying organization also listing key personnel with appropriate accreditations including the name of CETA-certified technician performing the testing.

2. Confirming remark that facility/equipment was tested “in accordance with CETA CAG-003:2022 (or most current version) and any other applicable performance testing standard followed. The most current version of this CAG must be referenced. Note: USP 797 is not a certification specification.

3. Explanation of test procedure used for data collection and justification for any deviations from established industry practices encountered during the certification process.

4. A list of test equipment utilized in data collection. List shall include make, model, serial number, and calibration date. A copy of the current calibration documentation for each piece of equipment must be provided when requested.

5. Required reporting values listed in each test section

6. Type, make, model and serial number for each PEC tested

7. Each PEC and SEC nonviable particulate counts (including sample volume and time) and ISO classification

8. Measured air velocity data for PEC, including air flow in CFM, average and standard deviation of air velocity measurements and acceptance criteria

9. PEC blower setting and pressure gauge reading (if any)

10. For BSCs:

a. measured downflow air velocity data, acceptance criteria and pass/fail result

b. measured exhaust damper acceptance criteria and pass/fail result

c. inflow velocity test method, measurements, and results

11. Documentation of results for the video of the airflow smoke pattern test documenting unidirectional flow at critical sites in the PEC.

12. Total Air Changes Per Hour (ACPH) for each SEC, with indication of ACPH supplied by the PECs

13. Pressure differentials between each SEC and the anteroom/pharmacy

14. Results of HEPA leak tests for all filters tested, as well as the results of any patching that was performed

15. If leaks were detected and sealed, include a diagram showing approximate location of sealed leaks

16. Prefilter type, size, and condition for each PEC

17. SEC temperature and relative humidity

18. Video recording of all smoke pattern testing (airflow and dynamic)

19. Alarm test results (if any)

20. A diagram of the areas tested, noting the approximate location of air and surface particle counts

21. Any recommendations for HEPA replacement/HEPA lifespan

ii. Microbiological lab analysis reports must meet the following:

1. The laboratory performing microbial analysis must be an American Association for Laboratory Accreditation (A2LA)-accredited laboratory with ISO/IEC 17025 certification for microbiological testing.

2. All viable and non-viable analyzed sampling results must be provided via email directly to the Chief of Facility Management Services, Chief of Pharmacy Service, and to the Designated Compounding Pharmacist no later than 14 calendar days after sampling is performed. At a minimum, the provided lab analysis report must include:

a. The manufacturer, lot number, and expiration date for each media lot analyzed.

b. Date and time sampling was performed.

c. Comments indicating sampling under dynamic conditions.

d. Sampling location(s), with a Site Map sketch identifying location of each sample obtained.

e. Sampling type and incubation dates, temperature, and duration intervals.

f. Quantitative number of discrete colonies of microorganisms on each media device as colony forming units (CFUs) of bacterial/fungal isolates. Results equal to or greater than the action level will require immediate notification to the facility’s the POC(s).

g. Recovered organisms identified to the genus level (The pharmacy must be notified of any microbial growth immediately after it is identified (no later than 48 hours after the report is received by the contractor from the laboratory).

h. Determination of whether lab findings are actionable (e.g., acceptable/unacceptable as per USP 797).

j. Response-Travel- Expense Considerations

i. Response Time- The Contractor shall use commercially reasonable efforts to:

1. Provide technical support via telephone to Northport VAMC on a 24/7, 365 days a year schedule.

2. Respond by telephone to any report of a malfunction requiring repair within one hour of notification.

3. Provide on-site support within 2 hours of notification unless prevented by unforeseen circumstances.

ii. Travel Time

1. Due to the time sensitive nature of testing, the contractor must guarantee a maximum two-hour time travel and arrival at facility on scheduled testing dates for any required testing personnel and equipment.

iii. Travel Expenses-

1. Contractor shall be responsible for all service-related equipment shipping and tester’s trip expenses, including but not limited to round trip travel, mileage, meals, and overnight living expenses.

k. Title to Equipment- Contractor shall not assume possession or control of any part of the equipment. The Government retains ownership to title thereof.

l. Utilities- Contractor may use Government utilities, (e.g., electrical power, compressed air, and water) which are available and required for any service performed under this contract.

m. Access to Equipment- Contractor shall be provided reasonable access to all equipment that is to be serviced, and utility outlets required to do the service. The contractor shall be free to start and stop all primary equipment incidentals to the operation of the maintained equipment after permission is received from on duty personnel responsible for such equipment.

n. Parts and Materials- All compensation for parts and materials is included in contract price.

o. Parts/Supplies Quality- Parts and Supplies provided under this contract shall be new OEM (Original Equipment Manufacturer) parts.

p. Field Service Reports- Contractor shall furnish a written or electronic vendor supplied Field Service Report (FSR).

q. Place of Performance.

Northport VAMC 79 Middleville Road Northport, N.Y. 11768

r. Period of Performance.

Base plus four (4) option years

Information Security/Privacy/ Records Management

1) This contract does not involve access to VA patient/employee information and does not involve access and/or connection to the VA information system.

2) VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or the Use of VA Sensitive Information

The Department of Veterans Affairs, VA must comply with all applicable privacy and confidentiality statutes and regulations. One of the requirements in VA is to have all personnel trained annually on privacy requirements. “Privacy” represents what must be protected by VA in the collection, use, and disclosure of personal information whether the medium is electronic, paper or verbal.

VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or the Use of VA Sensitive Information must be completed annually. The Contracting Officer Representative (COR/ COTR/ Project Manager) is responsible for obtaining this training from the contractor and to maintain according to the Records Control Schedule (RCS 10-1).

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

Bi-Annual Certification (every six (6) months) of 4 areas per CETA Application Guide CAG-008 “Certification Matrix for Sterile & Nonsterile USP Compounding Facilities" completed in less than 24 hours with final report provided no later than seven (7) calendar days after testing per SOW:

-January & July Contingency locations of Inpatient CAI & 2F (C-SCA, CACI, & HD Storage room) -March and September Unit 31 Cleanroom suite

As per CETA Application Guide CAG-008 “Certification Matrix for Sterile & Nonsterile USP Compounding Facilities.” This Application Guide serves as the baseline to having a Sterile Compounding Facility and its Primary Engineering Controls successfully certified in accordance with current ISO, USP, NSF and IEST standards. The requirements are laid out, test methods specified, acceptance criteria listed, and equipment needed to test secondary engineering controls described. Consideration should be taken to choose which test to use based on Secondary and Primary Engineering Control Type. Location testing procedures detailed as follows:

Contract Period: Base POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services PRODUCT/SERVICE CODE: H266 - Equipment and Materials Testing - Instruments and Laboratory Equipment

Tests appropriate to certify a cleanroom used in sterile compounding. USP requires all environmental controls to be certified at least every 6 months or whenever PECs or compounding devices within PECs are relocated/altered or when major service to the facility is performed. An additional Qty two (2) biannual certifications will be provided per annual obligation in the likelihood that PECs are relocated/altered or when major service to the facility is performed and/or the first certification fails. (per USP 797 (sets the industry standard) & VHA Directive 1108.12) Contract Period: Base POP Begin: 11-01-2025 POP End: 10-31-2026

Each month the lab will incubate & analyze Viable Surface Samples collected by the facility from ISO rated locations along with the necessary sample control (with the exception of months when Biannual Viable Air & Surface samples are collected in conjunction with equipment CETA testing for certification). Additionally Provide Viable Sampling, Surface, with Colony ID = Qty 39 Provide Viable Sample – Control = Qty 1 Provide Media Fill Testing Vials – Qty 20 Contract Period: Base POP Begin: 11-01-2025 POP End: 10-31-2026

Per annual obligation, an additional Qty of two (2) CETA Certifications will be provided in the event of a failure during regularly scheduled testing.

POP Begin: 11-01-2025 POP End: 10-31-2026

Once every six (6) months, certification testing procedures will be performed which comply to all applicable United States Pharmacopeia (USP) <797> and USP <800> PEC certifications and viable sampling requirements within Northport VAMC’s Unit 31 cleanroom suite, 2F C-SCA & CAI, 2F HD Storage room, and the Inpatient Pharmacy CAI. Additionally, on a monthly basis when CETA certification is not performed, viable surface samples collected from the previously mentioned locations, the GermFree trailer, and a control sample plate will be analyzed by the lab. All certification and testing procedures must adhere to defined applicable CETA Application Guides (including viable and non-viable testing)

POP Begin: 11-01-2025 POP End: 10-31-2026

Semi-Annual lab analysis of 14 HD wipe samples for trace contamination of 7 different drugs (This is performed twice a year)

POP Begin: 11-01-2025 POP End: 10-31-2026

LABOR: Contractor to provide emergency labor for repairs to hoods and/or replacement of HEPA and BAG filters to include cleaning of systems to keep the Pharmaceutical Compounding – Sterile Preparations operational. The mechanical equipment that is affixed to the building such as HVAC, reheat systems, sensors and controls are not covered under this contract line-item number.

POP Begin: 11-01-2025 POP End: 10-31-2026

MATERIALS: Contractor to provide emergency materials for repairs to hoods and/or replacement of HEPA and BAG filters to include cleaning of systems to keep the Pharmaceutical Compounding – Sterile Preparations operational. The mechanical equipment that is affixed to the building such as HVAC, reheat systems, sensors and controls are not covered under this contract line-item number.

POP Begin: 11-01-2025 POP End: 10-31-2026

Building 11:

Bi-Annual Certification (every six (6) months) of 4 areas per CETA Application Guide CAG-008 “Certification Matrix for Sterile & Nonsterile USP Compounding Facilities" completed in less than 24 hours with final report provided no later than seven (7) calendar days after testing per SOW:

- 11-239 (C-SCA, CACI, & HD Storage room

Per CETA Application Guide CAG-008 “Certification Matrix for Sterile & Nonsterile USP Compounding Facilities.” This Application Guide serves as the baseline to having a Sterile Compounding Facility and its Primary Engineering Controls successfully certified in accordance with current ISO, USP, NSF and IEST standards. The requirements are laid out, test methods specified, acceptance criteria listed, and equipment needed to test secondary engineering controls described. Consideration should be taken to choose which test to use based on Secondary and Primary Engineering Control Type. Location testing procedures detailed as follows:

Contract Period: Base POP Begin: 05-01-2026 POP End: 10-31-2026

Building 11 Once every six (6) months, certification testing procedures will be performed which comply to all applicable United States Pharmacopeia (USP) <797> and USP <800> PEC certifications and viable sampling requirements within Northport VAMC’s Unit 31 cleanroom suite, 2F C-SCA & CAI, 2F HD Storage room, and the Inpatient Pharmacy CAI. Additionally, on a monthly basis when CETA certification is not performed, viable surface samples collected from the previously mentioned locations, the GermFree trailer, and a control sample plate will be analyzed by the lab. All certification and testing procedures must adhere to defined applicable CETA Application Guides (including viable and non-viable testing) Contract Period: Base POP Begin: 05-01-2026 POP End: 10-31-2026

Bi-Annual Certification (every six (6) months) of 4 areas per CETA Application Guide CAG-008 “Certification Matrix for Sterile & Nonsterile USP Compounding Facilities" completed in less than 24 hours with final report provided no later than seven (7) calendar days…