36C24226Q0765.docx

SUBJECT*

USP Compliant Pharmacy Lab BSC and Fume Hood Certification Services

GENERAL INFORMATION

SET-ASIDE

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs 400 Fort Hill Ave.

Canandaigua NY 14424

POINT OF CONTACT*

Contract Specialist Cara Grittner Cara.grittner@va.gov Cara.grittner@va.gov

PLACE OF PERFORMANCE

ADDRESS

Department of Veterans Affairs

Stratton VA Medical Center

113 Holland Ave

Albany New York

ADDITIONAL INFORMATION

DESCRIPTION

If you would like assistance in responding to this post, please reach out to the Apex Accelerator Team in your area. Their website is https://www.apexaccelerators.us/#/ , and you can find your local office by searching the map on their home page. The Apex Accelerators offer a free service of assistance with reviewing and responding to government notices and postings for potential procurements.

a) This is a Sources Sought Notice

(a) The Government does not intend to award a contract on the basis of this Sources Sought or to otherwise pay for the information solicited.

(b) Although "proposal," "offeror," contractor, and "offeror" may be used in this sources sought notice, any response will be treated as information only. It shall not be used as a proposal. The Government is seeking information for market research purposes only.

(c) Any information received from a contractor in response to this Sources Sought may be used in creating a solicitation. Any information received which is marked with a statement, such as "proprietary" or "confidential," intended to restrict distribution will not be distributed outside of the Government, except as required by law.

(d) This Sources Sought is issued by VISN 2 Contracting Office in Canandaigua, NY for the purpose of collecting information about USP compliant Certification for the Sterile Compounding Pharmacy areas and Annual BSC/Fume hood Recertifications for the Albany (Stratton) VA Medical Center. The VA is seeking to provide for this requirement within 60 days of the award of the contract. The NAICS code identified for this requirement is 541380– Testing Laboratories and Services. The requirement is detailed in the Statement of Work (SOW) section of this document. NOTE: the SOW included is not the final SOW.

(e) Cursory market research has identified small businesses that may be able to provide the services for this requirement. Contractors that are able to meet the requirements in the attachment and possess an interest in performing these services, are encouraged to email a capability statement and full information to Cara Grittner at Cara.grittner@va.gov by 10:00 am EST on Wednesday, July 8, 2026. Phone calls will not be accepted. Please include: 36C24226Q0765, in the subject line.

b) Part of the purpose of this sources sought is to determine the viability of set aside to a specific socio-economic category (service-disabled veteran owned small business, veteran owned small business, women owned small business, HUB Zone, 8(a), small business). Interested parties MUST provide company/individual name, a capability statement, examples of same or similar work performed at other facilities, SAM UEID number and address, point of contact and social-economic.

c) If contractor is a Service-Disabled Veteran-Owned Small Business (SDVOSB), a Veteran-Owned Small Business (VOSB), or any other special category of contractors, then contractor is responsible for providing documentation in support of this. This information will be used to determine the viability of a set aside for this requirement.

d) The following information is required for determining procurement strategy and viability of sources:

Set-aside requirements have limitations on subcontracting. The services will be provided to the Albany, NY VA location. Provide your site location and any supporting documentation/capabilities.

If your intention is to subcontract work, what tasks will be performed by you as the prime contractor? What tasks will be performed by a subcontractor, if applicable?

How many jobs of this nature, of this scope and this complexity have you performed in the past five years?

How many certified/licensed technicians does your company currently employ?

- Contractors shall identify pertinent points of contact for company, and Prime and Sub-Prime (if applicable) Contractor SAM UEID number for verification in SAM.

- Contractor shall provide a listing of any teaming agreements they intend to employ in the performance of this requirement if awarded.

- Contractors shall include any relevant comments and/or questions about the Attachment(s) if applicable.

See attached document: SOW USP compliant Certification for the Sterile Compounding Pharmacy areas and Annual BSC/Fume hood Recertifications 2026 for Sources Sought.

Stratton VA Medical Center Albany, New York Request for Services-Statement of Work (SOW) USP Compliant Pharmacy Certification/&Lab BSC/Fume Hood Certification Services

1. Background

Albany VA Medical Center (Albany VAMC) requires a contract to provide all labor, materials and travel to perform the USP 797 and/or- compliant certification of the pharmacy compounding areas and Annual BSC/Fume hood recertifications throughout the Medical Center. This is a Base plus four (4) year contract.

2. Scope (Pharmacy)

A. All pharmacy-specific equipment will have CETA certification completed at least every six (6) calendar months from the date of the last certification/testing of biological safety cabinets, laminar flow hoods, ceiling mounted HEPA filters, and room spaces/environments in accordance with VHA Directive 1108.12, and USP 797 & 800. In addition, CETA certification of pharmacy sterile compounding areas or equipment must also be completed whenever it is required by USP 797 (e.g. after redesign, construction, replacement or relocation of any PEC, alteration in configuration of the room, or other event of significance). To ensure compliance with USP 800, certification of non-sterile compounding facilities and equipment will be completed semi-annually. Pharmacy specific spaces and equipment are as follows:

a. Sterile Compounding: 1B Pharmacy Primary Spaces

i. B122a - Outer room of Segregated Compounding Area, SCA (former anteroom)

ii. B122b: Inner room of SCA, two (2) Laminar Airflow Workbenches, and one (1) ceiling mounted HEPA filter outside SCA.

1. 6ft Baker EdgeGard - EG6320, SN: 144455

2. 4ft Baker EdgeGard - EG4320, SN: 142230

d. Non-sterile Compounding: Negative Pressure 1B Pharmacy Space (testing for USP 800 only)

i. B126a: one (1) Ductless Double Filter Fume Hood, Containment Ventilated Enclosure

1. Test to manufacturer specifications

2. Perform smoke pattern testing with video recording

3. Check velocity

4. Check HEPA filter integrity

ii. Negative Pressure Receiving Area

1. Determine room diferential pressures

2. Check functionality of pressure gauge

3. Determine air velocity and calculate air changes per hour

4. Conduct temperature and humidity testing with calibrated device B. The contractor shall:

a. CETA certify spaces listed in section 2A above using CAG-003 - current version, semi-annually (every 6 months)

i. Note: Secondary Engineering Controls (SECs) B122a and B122b are non-ISO classified spaces and will be tested to the cleanroom standards for information only

b. Perform all required semi-annual testing of primary and secondary engineering controls to meet the compounding requirements set forth in USP 797 and USP 800.

c. Perform semi-annual air & surface viable environmental sampling (bacterial & fungal), reporting counts of recovered colony forming units (CFUs). All environmental microbiologic testing is to be performed by an accredited environmental testing laboratory (ie A2LA) and the laboratory report provided to the CSP pharmacist. Samples must be labeled, and a diagram of sampling locations provided.

d. Certification periodicities shall be confirmed by contractor, post award, and adjusted as necessary to meet the needs of the Albany VA Medical Center. Certification and testing shall conform to USP, CETA and OSHA standards.

i. Sampling shall include:

1. Viable surface sampling of all classified areas (primary and secondary engineering controls) including equipment contained within the PEC, and staging or work areas near the PEC that are frequently touched. Sampling for microbial contamination must be conducted semi-annually during certification.

2. Viable air sampling of all classified areas (primary and secondary engineering controls) conducted during semi-annual certification.

e. Perform semi-annual non-viable particle count testing (0.5 micron and larger) under dynamic operating conditions to calculate room ISO rating. This must be completed for all primary and secondary engineering controls.

f. Measure and document HEPA filter(s) air volumes and velocities semi-annually.

g. Perform room calculations to determine air changes per hour (ACPH) in each room.

h. For Primary Engineering Controls (BSCs and LAFWs)

i. Perform HEPA filter integrity testing and perform patching of leaks if necessary.

ii. Perform prefilter check

iii. Perform viable air (impact volumetric airborne particulate sampling) and surface sampling.

iv. Perform non-viable particle count testing (0.5 micron and larger) under dynamic operating conditions inside each PEC to calculate ISO rating.

v. Perform dynamic smoke testing (video recorded and made available for download on a secure website) for all primary engineering controls; must have sufficient smoke and record from multiple angles to demonstrate

vi. unidirectional airflow and sweeping action over and away from any preparation.

vii. Measure downflow air velocity (BSC)

viii. Check exhaust damper (BSC)

ix. Measure inflow velocity (BSC)

x. Check function of any alarms (BSC)

x. The certification tag must be updated on each of the PECs that pass certification.

i. For Secondary Engineering Controls

i. Perform HEPA filer leak testing (integrity testing) for all engineering controls listed in 2A above. If leak is found, patch as appropriate

ii. Perform viable air (impact volumetric airborne particulate sampling) and surface sampling.

iii. Perform non-viable particle count testing (0.5 micron and larger) under dynamic operating conditions inside each PEC to calculate ISO rating

iv. Measure pressure differentials between each pair of SECs and between the anteroom and general pharmacy area.

v. Conduct smoke pattern testing between each pair of SECs and between anteroom and general pharmacy area to establish direction of airflow

vi. Test airflow directionality: at air returns and at doors

vii. Conduct temperature and humidity testing with calibrated device

viii. Perform calibration of room pressure differential gauges. Gauges will be affixed with calibration sticker.

ix. Measure and determine Air Changes Per Hour (ACPH) from HVAC, ACPH contributed from PEC, and the total ACPH.

j. Report results as follows (Pharmacy Results Only)

i. Contractor shall provide a written report of all testing and certification results, no later than seven (7) business days following completion of all work (except for viable sampling results). All reports must be sent via email or secure link/portal (due to email size constraints) directly to the COR and to the CSP pharmacist.

ii. At a minimum, this report must contain:

1. Name of CETA-certified technician performing the testing

2. A certificate indicating compliance with testing standards

3. List of equipment used for the testing: manufacturer, model, serial number and calibration due date

4. Number of personnel in the room

5. Type, make, model and serial number for each PEC

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

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

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

9. For BSCs: measured downflow air velocity data, acceptance criteria and pass/fail result.

10. For BSCs: measured exhaust damper acceptance criteria and pass/fail result

11. For BSCs: inflow velocity test method, measurements and results

12. Air Changes Per Hour (ACPH) from HVAC, ACPH contributed from PEC, and the total ACPH.

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. Viable testing results (once available). The microbiology report must include:

a. Sampling location and counts of any CFUs recovered (or as specified in USP 797)

b. Incubation of temperature and duration.

c. Manufacturer, lot number and expiration for each media lot.

d. Positive and negative controls.

e. Determination of whether findings are actionable (pass/fail)

f. Chain of custody for samples.

18. SEC temperature and relative humidity.

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

20. Alarm test results (if any).

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

22. Any recommendations for HEPA replacement/HEPA lifespan.

23. Performance standard used for testing.

24. The CSP pharmacist 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).iii. For non-sterile compounding/receiving areas report must include:

1. For Containment Ventilated Enclosure

a. Video recording of smoke pattern testing of the containment ventilated enclosure. Video must be made available for download on a secure website.

b. Results of testing to manufacturer specifications

c. Inflow velocity testing results

d. Assessment of HEPA filters, including any leakage or patching that was needed

e. List of equipment used for the testing: manufacturer, model, serial number and calibration due date.

2. For Receiving Area Spaces:

a. Diagram of airflow within the receiving area spaces

b. Report of temperature and humidity testing

c. Pressure gauge verification report with testing parameters and indication of pass/fail.

d. Room air volume and velocity report

e. Number of air changes per hour

f. Room pressure differentials for exterior hallway to receiving area and pharmacy hallway to receiving area

g. List of equipment used for the testing: manufacturer, model, serial number and calibration due date.

C. Additional Requirements:

iii. The individual performing the testing shall be CETA certified to perform this work. The technician/contractor shall provide a copy of the individuals CETA credentials at time of offer. If, during the contract, a different individual(s) is designated by the contractor, CETA certification of the individual(s) must be provided to the CO and COR and approved prior to the start of work.

iv. The contractor shall comply with Federal, State, and Local Laws, and federal regulations as applicable to the performance of this contract; to include USP 797 and USP 800.

v. The contractor shall obtain all necessary licenses and/or permits required to perform the work herein.

vi. Contractor will supply all necessary equipment for the certification and microbial testing of the sterile compounding area (cleanroom suite or SCA) Sources Sought Notice

vii. The contractor shall follow Albany VAMC protocols for use of personal protective equipment (PPE) in the classified spaces and understand the risks associated with facilities and equipment designed for storage and preparation of hazardous drugs.

Sources Sought Notice

iii. Disinfect and sanitize all equipment brought into the cleanroom suite or SCA prior to entry (with Caviwipe, followed by sterile 70% isopropyl alcohol or as per current standard operating procedure for the cleanroom suite).

iv. The contractor shall ensure all equipment used in testing has been serviced and calibrated as recommended by the manufacturer.

v. Response Time in the Event of Urgent Need (Pharmacy Only): Contractor shall use commercially reasonable eforts to:

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

2. Provide on-site support within 24 hours of notification unless prevented by unforeseen circumstances

FILTER FUME HOOD

VENT HOOD

VENT HOOD

d. Scope Laboratory Equipment Certification:

i. Perform annual certification of eight (6) Biological Safety Cabinets and four (5) Chemical Fume Hoods in accordance with the following standards and per manufacturer specifications:

ii. NSF / ANSI 49 (Biological Safety Cabinets)

iii. IEST-RP-CC034.3 (HEPA Filter Leak Testing)

iv. Inventory.

on

SCIENTIFIC INC

STAR

30014645 C305-1-

AL

A,D,-P3

NU4254

1-AL

CLASS II, TYPE 2A

NU4254

AL

CLASS II, TYPE 2A

NU4256

12343905 B316B-

1-AL

SCIENTIFIC INC

STAR

30014645 C305-1-

AL

SCIENTIFIC INC

THERMO SCIEN 1300 SERIES

CLASS 2 TYPE A2

C310-1-

AL

al

al

CLASS II, TYPE 2A

NU4253

AL

LABORATORY

THERMO SCIENTIFIC FUMIGATION

VENT/HOOD

B316-1-

AL

LABORATORY

BIOLOGICAL SAFETY CABINET

CLASS II, TYPE 2A

B316A-

1-AL

ii. Scope Research Equipment

1. Perform annual certification of six (9) Fume Hoods in accordance with the following standards and per manufacturer specifications:

2. ANSI/ASHRAE STANDARD 110-2016

3. Inventory

AL

RESEARCH (ARF)

1-al

RESEARCH

(FUME HOOD)

1-al

RESEARCH

OWN

1-AL

RESEARCH

IND

3-AL

RESEARCH (ARF)

IND

3-AL

RESEARCH (ARF)

IND

3-AL

RESEARCH (ARF)

14059294 132-3-

AL

RESEARCH (ARF)

125-3-

AL

RESEARCH (ARF)

j. Scope Dental/Prosthetics Equipment

· Perform annual certification of (2) Fume Hoods in accordance with the following standards and per manufacturer specifications:

· ANSI/ASHRAE STANDARD 110-2016

· Inventory.

Name Mod el

on Owner/Depart ment

FUMEHOOD

30300 120600

MANUFACTURING INC

MOTT FUME

HOOD

72210

AL

PROSTHETIC

xi. Travel and Related Expenses Contractor shall be responsible for its service-related trip expenses including round trip travel, mileage, and overnight living expenses.

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

k. 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.

l. Access to Equipment Contractor shall be provided with 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.

m. Technical Support Technical support shall be made available from the Contractor to Stratton VAMC 24/7, 365 days a year via telephone.

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

26. Parts/Supplies Quality Parts and Supplies provided under this contract shall be new OEM parts.

3. Field Service Reports Contractor shall provide a written or electronic report of all testing and certification results, no later than seven (7) business days following completion of all work (except for viable sampling results). Contractor shall include Summary tables listing all rooms or areas tested and the acceptable limits, actual readings and indication of testing results (e.g. pass/fail) for the designated testing criteria for compliance.

4. Place of Performance.

Stratton VAMC 113 Holland Ave Albany, NY 12208

16. Period of Performance.

Base plus four (4) option years

Base: 1 Oct 2026-30 Sep 2027 Option Year 1: 1 Oct 2027-30 Sep 2028 Option Year 2: 1 Oct 2028-30 Sep 2029 Option Year 3: 1 Oct 2029-30 Sep 2030 Option Year 4: 1 Oct 2030-30 Sep 2031

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