36C25224Q0625.docx

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

None 36C25224Q0625 10-15-2024 Parrott,Romell 414-844-4800 X43256 10-31-2024

5PM

CDT

Department of Veterans Affairs

GLAC (69D)

115 South 84th Street, Suite 101 Milwaukee

WI

53214-1476 X X 541380 $19 Million N/A X Edward J. Hines VA Hospital 5000 S 5th Ave.

Hines

IL

60141-3030 Department of Veterans Affairs

GLAC-MILWAUKEE (69D)

Great Lakes Acquisition Center - HC 115 South 84th Street, Suite 101 Milwaukee

WI

53214-1476

Department of Veterans Affairs Financial Services Center PO Box 149971 Austin

TX

78714-9971 See CONTINUATION Page This RFQ is for Biological saftey cabinets, & Clean air testing annually at the Edward J HInes Jr. VA Hospital in accordance with the Statement of Work.

Service Contract Labor Standard shall apply to any award made from this Soliciation:

DOL WD 2015-5017 (Rev-27) dated 7.22.2024 This is a Service Disabled Veteran Owned SB Set Aside See CONTINUATION Page X Table of Contents

B.1 CONTRACT ADMINISTRATION DATA (continuation from Standard Form 1449)

OFFERORS MUST COMPLETE AND RETURN ALL INFORMATION DESIGNATED HEREIN PRIOR TO THE TIME SPECIFIED IN BLOCK 8 OF SF 1449 IN ORDER TO BE CONSIDERED FOR AWARD.

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

1. CONTRACT ADMINISTRATION: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

CONTRACTOR NAME _____________________________________

ADDRESS ________________________________________________

CITY-STATE-ZIP __________________________________________

POINT OF CONTACT/TITLE ________________________________

SAM UEI NO. ____________________________________________

CAGE CODE _____________________________________________

CONTRACTOR’S PAST PERFORMANCE POINT OF CONTACT

(IF DIFFERENT THAN ABOVE):

NAME: __________________________________________

EMAIL ADDRESS: _________________________________

b. GOVERNMENT: Romell Parrott Contract Specialist

CONTRACTING OFFICE CODE: 36C252

MILWAUKEE WI 53214

2. ACQUISITION OF COMMERCIAL ITEMS

This Request for Quote (RFQ) solicitation is issued under the authority of FAR Part 12 Acquisition of Commercial Items and FAR Part 13 Simplified Acquisition Procedures. FAR Part 15 will not be used. The procedures in Part 12 used in conjunction with Part 13 allow the Government to procure services resembling those in the commercial marketplace and streamline the procurement process. From this RFQ, the Government intends to award a firm fixed price contract where the contractor provides a price that is not subject to any adjustment on the basis of the contractor’s cost experience in performing the contract. (Note: The terms “offeror” and “quoter” are both used in this Solicitation. For the purposes of this Solicitation, these terms are interchangeable; there is no difference in meaning between the two.)

SET-ASIDE : See box 10 of STANDARD FORM 1449

SOLICITATION TIMELINE SUMMARY:

A. RFQ QUESTIONS:

In order to maintain integrity of this solicitation and subsequent award date, all offerors are advised that any question-and-answer requests must be submitted in a written form via e-mail to the Contracting Officer Romell.Parrott@va.gov no later than October 21, 2024, AT 12pm LOCAL TIME. Contracting will issue a consolidated response via solicitation amendment to https://sam.gov Contract Opportunities within 2 business days to all parties.

B. SOLICITATION CLOSES/QUOTES DUE:

See box 8 of STANDARD FORM 1449 or most recent Amendment.

C. SUBMISSION OF QUOTE:

See 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services and addendum for specific instructions to offerors.

3. CONTRACTING OFFICER AUTHORITY:

The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitment or issue changes that will affect price, quantity or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in cost incurred thereof.

4. INVOICES:

a. All payments by the Government to the contractor will be made in accordance with: FAR 52.232-33 PAYMENT BY ELECTRONIC FUNDS TRANSFER – SYSTEM FOR AWARD MANAGEMENT (OCT 2018)

b. Invoices shall be submitted (Annually.) in arrears in accordance with: 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

c. Payments shall be made in arrears upon receipt of a properly prepared invoice

d. Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests.

e. The VA has mandated electronic invoice submission to the Veterans Affairs Financial Services Center (VAFSC). VAFSC has partnered with Tungsten Network e-Invoicing network, for submissions of all electronic invoices to VA. Tungsten Network electronic invoicing is free to all VA vendors. In order to submit electronic invoices, all VA vendors must register with Tungsten Network by submitting an email to VA.Registration@Tungsten-Network.com or calling 1-877-489-6135 for Enrollment.

f. Contractor shall submit an electronic invoice by the tenth (10th) of the following month services were performed to the Veterans Affairs Financial Services Center (VAFSC) e-Invoice through the website at https://portal.Tungsten-Network.com/Login.aspx. For questions regarding the submission of VA electronic invoices, Tungsten Network customer service may be contacted at 1-877-489-6135.

g. All invoices shall reference the vendor’s name and address, customer name, contract number, appropriate obligation/funding order number, description of services provided, quantity, unit price, and total invoice amount (any additional info). Invoices shall also include any payment discount terms.

h. VA’s Electronic Invoice Presentment and Payment System – The Veterans Affairs Financial Services Center (VAFSC) uses a third-party contractor, Tungsten Network e-Invoice, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/customer-campaigns/veteransaffairs/ to begin submitting electronic invoices, free of charge.

i. As of July 1, 2020, the VA10091 form has been eliminated and the VAFSC is requiring our vendors to update and add their information in the Customer Engagement Portal (CEP) at https://www.cep.fsc.va.gov/. This is for new vendors being added to FMS only.

j. For assistance setting up e-Invoice, the below information is provided:

* Tungsten Network e-Invoice Setup Information: 1-877-489-6135

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

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

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

5. FACILITY REQUIREMENTS: In addition to any other requirements set forth in this Contract, the Contractor, including its employees, agents, and subcontractors (collectively “the Contractor”), shall comply with the following facility requirements. Failure to comply with these requirements shall be considered a material breach of this Contract and may be a violation of Federal law resulting in charges answerable in the United States District Court.

a. Contractor is responsible to follow all on site facility policies

b. All VA property is considered Federal property and all Federal laws are applicable.

c. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. The VA will not invalidate or make reimbursement for parking violations of the Contractor under any conditions.

d. All VA facilities are drug free. Possession of drugs, to include Marijuana and all Marijuana bi-products are prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

e. All contractor personnel are required to adhere to all VA rules and regulations.

f. Smoking is prohibited on the entire campus, both inside and outside the VA Facility

g. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

h. VHA DIRECTIVE 1192: This Veterans Health Administration (VHA) directive establishes policy and provides guidance for the prevention of seasonal influenza in VHA facilities through the vaccination or masking of health care personnel (HCP). AUTHORITY: Title 38 United States Code (U.S.C.) 7301(b), 7318(b). Contractor is responsible in ensuring that all aspects of this directive are implemented, including providing face masks and influenza vaccines for all employees working at a VA facility.

6. SECURITY & PRIVACY CONTROL:

The Authorization & Accreditation (A&A) requirements of VHA Handbook 6500.6 do not apply to this requirement, therefore, a Security Accreditation Package is not required. No A&A or MOU/ISA is required. Sensitive information exposure as part of this contract involves applicable security controls within the facility as part of the VA Information Security If there are any questions related to privacy, please have a member of your staff contact the VA Privacy Service at (202) 461-6309. If there are any questions related to the information security, please have a member of your staff contact the Office of Cyber Security at (304) 262-7733.

B.3 STATEMENT OF WORK/PWS

1. GENERAL REQUIREMENT

Biosafety cabinet and clean room certification contract

Description of Services/Introduction: The contractor shall provide all labor, materials, supervision, tools, and equipment, necessary to perform semi-annual certification and monthly testing services for Hines VA Medical Center Pharmacy clean rooms, as well as biological safety cabinets, clean-benches, and other similar equipment (see attachment A). Equipment tested under this contract is used for research, laboratory, and both hazardous and non-hazardous drug compounding to ISO Class 5 and USP 800 standards.

1.1. Place of Performance

Edward J. Hines Jr. VA Hospital

2. SPECIFIC REQUIREMENTS/DELIVERY SCHEDULE/SCOPE/OBJECTIVES

Work shall include reports covering biological safety cabinets, clean-benches, fume hoods, bedding disposal stations, barrier isolators, smoke pattern and airflow volume testing. Work will be located at the Edward Hines Jr. VA Hospital, 5000 s. 5th Avenue, Hines, IL.

The contractor shall follow all National Sanitation Foundation (NSF) standard Number 49 and CETA Certification Application Guide (CAG) most recent edition to determine and ensure compliance with requirements for testing and certification. Work shall be performed by Controlled Environment Testing Association National Board of Testing (CNBT) credentialed professionals.

Certifier responsible for taking any necessary control samples.

CLIN 1: Semi-Annual (January and July) Certifications at 1st floor Main IV Room B109F (including ante room and airlock). -Contract shall include the below for each certification.

1. Certification of two horizontal Laminar Flow Clean Bench (Baker Edgegard 4252). Details shall include but not limited to:

a. Hepa Filter Leak Test of Hood (There are 2)

b. Air Velocity Profile to include downflow, inflow face velocity and cfm, and exhaust cfm.

c. ISO classification as determined by particle counts

d. Confirmation of function for sash alarm test, fan speed, and details of general settings.

2. Smoke pattern test performed inside the Clean Bench-Primary engineering control (PEC) and also outside the Clean Bench and within the three separate spaces (IV room, Ante Room, Air Lock).

a. Provide video documentation in a compressed video file viewable with standard Microsoft Windows operating systems and under 20MB per file. Quality must be clear enough to see the smoke and results of the test.

3. In room airflow testing – Room is considered a secondary engineering control (SEC). Testing to include

a. Air volume at each supply, return, exhaust damper.

b. Measurement of each room dimension and total air volume,

c. Calculation of Air Changes Per Hour

d. HEPA leak tests (there are 4 HEPA Filters in this area),

e. Air pressure measured relative to each room and marked by testing technician with an arrow on a floor plan to indicate the direction of airflow.

4. Air sampling in each ISO classified area (Ante Room, Air Lock, and IV Room)

a. Minimum 6 air samples to capture particle counts in each space.

b. Minimum 6 air samples to capture air bacterial and air fungal growth. It is the responsibility of the certifier to take the proper quantity of positive and negative controls during each environmental sampling visit. All detections must be speciated to the genus level. (Up to 10 total for all areas of this contract)

c. Incubation parameters to follow USP 797 most recent version (2022 at time of this SOW) and provided in a separate laboratory report.

5. Surface sampling in (Ante Room, Air Lock, and IV Room)

a. Minimum 6 samples to capture bacterial and fungal growth. It is the responsibility of the certifier to take the proper quantity of positive and negative controls during each environmental sampling visit. All detections must be speciated to the genus level.

b. Incubation parameters to follow USP 797 most recent version (2022 at time of this SOW) and provided in a separate laboratory report.

6. Temperature and Humidity Capture.

7. Any other tests as determined by industry, hood manufacturer, or CAG standards.

CLIN 2: Semi-Annual (January and July) Certifications at 11th floor Hazardous Drug Compounding Room 1118 (anteroom and Containment Segregated Compounding Area C-SCA) -Contract shall include the below for each certification.

1. Certification of one compounding aseptic isolator (CAI-model Germfree LFI USP3)

2. Certification of one containment aseptic compounding isolator (CACI- model Germfree LFGI USP6)

3. Smoke pattern test performed inside the Clean Bench-Primary engineering control (PEC) and also outside the Clean Bench and within the separate spaces (Ante Room, Compounding room).

a. Provide video documentation in a compressed video file viewable with standard Microsoft Windows operating systems and under 20MB per file. Quality must be clear enough to see the smoke and results of the test.

4. In room airflow testing – Room is considered a C-secondary engineering control (SEC). Testing to include

a. Air volume at each supply, return, exhaust damper.

b. Measurement of each room dimension and total air volume,

c. Calculation of Air Changes Per Hour

d. Non-Iso classified – No HEPA leak tests

e. Air pressure measured relative to each room and marked by testing technician with an arrow on a floor plan to indicate the direction of airflow.

5. Air sampling in each ISO classified area (Ante Room, and Compounding Room)

a. Minimum 6 air samples to capture particle counts in each space.

b. Minimum 6 air samples. It is the responsibility of the certifier to take the proper quantity of positive and negative controls during each environmental sampling visit. Test to capture air bacterial and air fungal growth. All detections must be speciated to the genus level. (Up to 10 total for all areas of this contract)

c. Incubation parameters to follow USP 800 most recent version (2022 at time of this SOW) and provided in a separate laboratory report.

6. Surface sampling in (Ante Room, and Compounding Room)

a. Minimum 6 samples to capture bacterial and fungal growth. It is the responsibility of the certifier to take the proper quantity of positive and negative controls during each environmental sampling visit. All detections must be speciated to the genus level. (Up to 10 total for all areas of this contract)

b. Incubation parameters to follow USP 800 most recent version (2022 at time of this SOW) and provided in a separate laboratory report.

7. Temperature and Humidity Capture.

8. Any other tests as determined by industry, hood manufacturer, or CAG standards.

CLIN 3: Semi-annual (January and July) Certifications at 9th floor Hazardous Drug Compounding Room 970 (anteroom), 970a (Compounding Room-Secondary Engineering Control SEC) -Contract shall include the below for each certification.

1. Certification of one compounding aseptic isolator (CAI-model Germfree LFI USP3)

2. Certification of two horizontal bench (BioChemGard -BCG401) External Exhaust. Details shall include but not limited to:

a. Hepa Filter Leak Test of Hood (There are 2)

b. Air Velocity Profile to include downflow, inflow face velocity and cfm, and exhaust cfm.

c. ISO classification as determined by particle counts

d. Confirmation of function for sash alarm test, fan speed, and details of general settings.

2. Smoke pattern test performed inside the Clean Bench-Primary engineering control (PEC) and also outside the Clean Bench and within the two separate spaces (IV room, Ante Room).

a. Provide video documentation in a compressed video file viewable with standard Microsoft Windows operating systems and under 20MB per file. Quality must be clear enough to see the smoke and results of the test.

3. In room airflow testing – Room is considered a secondary engineering control (SEC). Testing to include

a. Air volume at each supply, return, exhaust damper.

b. Measurement of each room dimension and total air volume,

c. Calculation of Air Changes Per Hour

d. HEPA leak tests (there are 3 HEPA Filters in this area),

e. Air pressure measured relative to each room and marked by testing technician with an arrow on a floor plan to indicate the direction of airflow.

4. Air sampling in each ISO classified area (Ante Room, and IV Room)

a. Minimum 6 air samples to capture particle counts in each space.

b. Minimum 6 air samples to capture air bacterial and air fungal growth. It is the responsibility of the certifier to take the proper quantity of positive and negative controls during each environmental sampling visit. All detections must be speciated to the genus level. (Up to 10 total for all areas of this contract)

c. Incubation parameters to follow USP 800 most recent version (2022 at time of this SOW) and provided in a separate laboratory report.

5. Surface sampling in (Ante Room, Air Lock, and IV Room)

a. Minimum 6 samples to capture bacterial and fungal growth. It is the responsibility of the certifier to take the proper quantity of positive and negative controls during each environmental sampling visit. All detections must be speciated to the genus level. (Up to 10 total for all areas of this contract)

b. Incubation parameters to follow USP 800 most recent version (2022 at time of this SOW) and provided in a separate laboratory report.

6. Temperature and Humidity Capture.

7. Any other tests as determined by industry, hood manufacturer, or CAG standards.

CLIN 4: Monthly Surface Sampling for Pharmacy Locations. (Include all the below for each of 12 Months)

1. Location B109F

a. Ante Room = 1 sample

b. Airlock Room = 1 sample

c. IV Buffer Room = 1 sample

d. 2 Laminar Air Flow Workbench (LAFW) = 2 samples (1 each bench)

e. Passthrough window = 1 sample

2. Location 1118 Hazardous Compounding Primary Engineering Controls (PEC)

a. Compounding Aseptic Containment Isolator (CACI) = 4 samples (1 each chamber)

b. Compounding Aseptic Isolator (CAI) = 2 samples (1 each chamber)

3. Location 970 Compounding surfaces

a. Compounding Aseptic Containment Isolator (CAI) = 2 samples (1 each chamber)

b. 2 Biological Safety Cabinet (BSC, type B2) = 2 samples (1 each)

c. Buffer room 970a = 1 sample

d. Ante room 970 = 1 sample

CLIN 5: Pharmacy Compounding Aseptic Isolator (CAI); One-time Certification outside of the normal January July certification window.

1. Certification of one horizontal bench (BioChemGard -BCG401) External Exhaust. Details shall include but not limited to:

a. Hepa Filter Leak Test of Hood (There are 2)

b. Air Velocity Profile to include downflow, inflow face velocity and cfm, and exhaust cfm.

c. ISO classification as determined by particle counts

d. Confirmation of function for sash alarm test, fan speed, and details of general settings.

2. Smoke pattern test performed inside the Clean Bench-Primary engineering control (PEC) and also outside the Clean Bench.

a. Provide video documentation in a compressed video file viewable with standard Microsoft Windows operating systems and under 20MB per file. Quality must be clear enough to see the smoke and results of the test.

3. 2 surface samples

4. 2 air samples

CLIN 6: Pharmacy Laminar Airflow Workbench (LAFW); One-time Certification of 2 units outside of normal January/July certification window.

1. Certification of two horizontal Laminar Flow Clean Bench (Baker Edgegard 4252). Details shall include but not limited to:

a. Hepa Filter Leak Test of Hood (There are 2)

b. Air Velocity Profile to include downflow, inflow face velocity and cfm, and exhaust cfm.

c. ISO classification as determined by particle counts

d. Confirmation of function for sash alarm test, fan speed, and details of general settings.

2. Smoke pattern test performed inside the Clean Bench-Primary engineering control (PEC) and also outside the Clean Bench.

a. Provide video documentation in a compressed video file viewable with standard Microsoft Windows operating systems and under 20MB per file. Quality must be clear enough to see the smoke and results of the test.

3. Surface sampling of each hood

a. 1 sample each for total of 2 samples to capture bacterial and fungal growth. It is the responsibility of the certifier to take the proper quantity of positive and negative controls during each environmental sampling visit. All detections must be speciated to the genus level.

b. Incubation parameters to follow USP 797 most recent version (2022 at time of this SOW) and provided in a separate laboratory report.

4. Air Sampling at each hood.

a. Minimum 1 each for total of 2 air samples to capture air bacterial and air fungal growth. It is the responsibility of the certifier to take the proper quantity of positive and negative controls during each environmental sampling visit. All detections must be speciated to the genus level.

CLIN 7: Genus Speciation of sampling detections.

1. When a positive detection is made, speciation to the genus level may be requested from the COR. This contract shall include 10 speciation reports.

CLIN 8: One-time Decontamination for preparation to turn in. Research area Building 1.

1. Decontamination of old units will need to take place prior to certification of units listed in Semi-Annual Certification Services for Research. This is so old units can be removed and new units moved into place.

2. Decontamination process needs to include

a. bagging the units prior to decontamination,

b. chlorine dioxide decontamination of the units,

c. evacuation and collection of chlorine dioxide gas post decontamination,

d. removal and bagging of the unit’s decontaminated filters (for disposal by Hines),

e. provision of printed decontamination certificates for each unit and filter. Each decontamination certificate should include unit’s make model and serial number, date decontaminated, printed name of contractor/business and printed name of technician along with signature.

3. See complete detail in attachment BSCs in Research Needing Deontamination. The following are included

a. B303a-1 BSC, Class II, Type A2

b. B303a-1 BSC, Class II, Type A2

e. C422-1 BSC, Class II, Type A2

j. B445a-1 BSC, Class II, Type A2

k. 110-229 BSC, Class II, Type A/B3

CLIN 9: Semi-Annual (January and July) Certifications Services for Research Areas Building 1 and Building 229.

1. Location Research Building 1, Floor 3. Perform functional testing to certify operation to standard and take one sample at each.

a. A300 BSC, Class II, Type A2

b. A340 BSC, Class II, Type A2

c. A340 BSC, Class II, Type A2

d. B303a BSC, Class II, Type A2

e. B303a BSC, Class II, Type A2

f. B340 BSC, Class II, Type A2

g. B342 BSC, Class II, Type A2

h. C422-1 BSC, Class II, Type A2

i. C426 BSC, Class II, Type A2

j. C429BSC, Class II, Type A2

k. C432aBSC, Class II, Type A2

l. C432a Clean Bench, LAFW

m. C435 Clean Bench, LAFW

n. C435 BSC, Class II, Type A2

o. C435 BSC, Class II, Type A2

p. D400d BSC, Class II, Type A2

q. A414 BSC, Class II, Type A2

r. A414 Bedding Disposal Station

s. A424 BSC, Class II, Type A2

t. A424 Bedding Disposal Station

u. A426 Bedding Disposal Station

v. A427 BSC, Class II, Type A2

w. B400 Bedding Disposal Station

x. B400 Bedding Disposal Station

y. B440 BSC, Class II, Type A2

z. B445a BSC, Class II, Type A2

aa. 110-229 BSC, Class II, Type A2

ab. 111-229 BSC, Class II, Type A2

ac. 112-229 BSC, Class II, Type A2

CLIN 10: Semi-Annual (January and July) Certifications Services for Laboratory/Pathology Medicine Areas Building 1 and Building 200.

1. Location Laboratory/Pathology Building 200, Floor 1; Building 1, Floor 2, Section F; and Building 1, Floor 4 Section E. Perform functional testing to certify operation to standard and take one sample at each.

CLIN 11: Semi-Annual (January and July) Certifications Services for Surgery Building 200.

1. Perform functional testing to certify operation to standard and take one sample.

a. 2457-200 Specimen Rm , Ductless Chemical Workstation, Air Clean Systems AC600

2. RECOGNIZED HOLIDAYS

2.1 HOURS OF COVERAGE:

A. Normal hours of coverage are Monday through Friday from 7:00 am to 4:00 pm, local time, except National Holidays, as listed below.

NOTE: Holidays that fall on Saturday are observed on the preceding Friday. Holidays that fall on Sunday are observed on the following Monday. In addition to the days designated as National Holidays, the Government observes the following days:

· Any other day designated by Federal Statute

· Any other day designated by Executive Order

· Any other day designated by the President of the United States to be a national holiday

B. All service and repairs shall be performed during normal hours of coverage unless requested and approved by the Contracting Officer’s Representative (COR) or his/her designee.

C. If services are required after hours, the contractor shall be required to provide a written request, prior to any services being performed, for approval by the COR and/or designee. If such work falls on a National Holiday (Christmas, New Year’s Day, Memorial Day, Independence Day, Labor Day or Thanksgiving), service will be paid separate from this contract. An obligation number shall be obtained prior to commencement of service. Billing shall include service time and exclude all parts, as they are included in the terms of the contract. Service performed outside of the normal hours of operation at the request of the Field Service Engineer (FSE) shall be considered service during normal hours of coverage.

NOTE:All hardware and software updates and upgrade installations shall be scheduled and performed outside normal hours of coverage at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by the COR).

D. Contractor shall provide unlimited technical support via phone during twenty-four (24) hours per day, seven (7) days per week.

3. GOVERNMENT FURNISHED EQUIPMENT

No government equipment will be provided.

4. DOCUMENTATION/REPORTS/DELIVERABLES

All reports shall be provided in digital pdf via email to the Edward Hines Jr. VA Hospital Contracting Officer’s Representative (COR), detailing certification, repairs and other work performed, within ten (10) business days of completion of work. The report shall contain information required by applicable standards and the following:

1. A general summary for all units on which work was performed, which includes identification and location of units that passed certification, and units (if any) that did not pass. If any units do not pass certification, the summary should include recommendations for additional necessary repairs or actions.

2. Individual detailed records/reports for each unit on which work was performed. Individual reports will be numbered to coincide with the summary.

3. All sample locations documented in detail with floor plans marked and/or detailed description.

4. The date of certification for each unit, name of the individual and contracting company that performed certification, the date of the next needed recertification, the type, make, model serial number and location of the equipment. Confirmation on the specific CAG referenced during certification will be required on the report.

5. The number of personnel present in the PEC and SEC during particle counts and smoke pattern tests must be documented on the Pharmacy report.

6. Manufacturer’s specifications for test equipment used (including calibration dates).

7. All environmental samples taken must maintain a proper chain of custody by the certifier to reduce any adverse effects from environmental factors on samples taken, be delivered and/or mailed to an accredited external lab with no financial affiliation with certifier and must be received within the next business day for incubation by the external laboratory.

In addition to the emailed reports the following shall be provided:

1. Certification sticker will be affixed the same day by the service representative to the equipment. The sticker will state the date of certification, name of the individual and contracting company that performed certification, the date of the next needed recertification, as well as the make, model serial number and location of the equipment.

2. If equipment cannot be successfully certified, the service representative will affix signage to the equipment, stating “DO NOT USE! THIS EQUIPMENT IS NOT FUNCTIONING WITHIN SPECIFICATION”.

5. PERFORMANCE STANDARDS/INSPECTION/QUALITY CONTRACTOR QUALIFICATIONS

1. The certifier must ensure that all the people and equipment he/she is employing are to standards. Certification procedures must be performed by a CETA National Board of Testing (CNBT) registered Cleanroom certified individual in accordance with certification procedures defined in CETA CAG-003-2006. Technician performing the certification must be accredited by the CETA National Board of Testing (CNBT) and should be accredited by NSF International. Documentation of credentials must be furnished upon request.

2. Certifier responsible for taking any necessary control samples.

3. All contractor personnel shall be properly badged through the Hines Personnel Identification Verification (PIV) process or they must be escorted by Hines authorized individual.

4. Contractor must schedule the site visit with COR a minimum of 10 calendar days in advance.

5. The external laboratory used by the certifier for monthly surface sampling must incubate all monthly samples in accordance with incubation duration, media requirements, and incubation parameters as outlined in USP <797/800> most recent edition (2022 at time of SOW).

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B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

Semi-Annual (January and July) Certifications at 1st floor Main IV Room B109F (including ante room and airlock).

Contract Period: Base POP Begin: 01-01-2025 POP End: 12-31-2025 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services PRODUCT/SERVICE CODE: H266 - Equipment and Materials Testing - Instruments and Laboratory Equipment

Semi-Annual (January and July) Certifications at 11th floor Hazardous Drug Compounding Room 1118 Contract Period: Base POP Begin: 01-01-2025 POP End: 12-31-2025

Semi-annual (January and July) Certifications at 9th floor Hazardous Drug Compounding Room 970

POP Begin: 01-01-2025 POP End: 12-31-2025

Monthly Surface Sampling for Pharmacy Locations. (Include all the below for each of 12 Months)

POP End: 12-31-2025

Pharmacy Compounding Aseptic Isolator (CAI); One-time Certification outside of the normal January July certification window.

POP Begin: 01-01-2025 POP End: 12-31-2025

Pharmacy Laminar Airflow Workbench (LAFW); One-time Certification of 2 units outside of normal January/July certification window.

POP Begin: 01-01-2025 POP End: 12-31-2025

Genus Speciation of sampling detections.

POP Begin: 01-01-2025 POP End: 12-31-2025

One-time Decontamination for preparation to turn in. Research area Building 1.

POP Begin: 01-01-2025 POP End: 12-31-2025

Semi-Annual (January and July) Certifications Services for Research Areas Building 1 and Building 229.

POP End: 12-31-2025

: Semi-Annual (January and July) Certifications Services for Laboratory/Pathology Medicine Areas Building 1 and Building 200.

POP Begin: 01-01-2025 POP End: 12-31-2025

Semi-Annual (January and July) Certifications Services for Surgery Building 200.

POP Begin: 01-01-2025 POP End: 12-31-2025

Semi-Annual (January and July) Certifications at 1st floor Main IV Room B109F (including ante room and airlock).

Contract Period: Option 1 POP Begin: 01-01-2026 POP End: 12-31-2026

Semi-Annual (January and July) Certifications at 11th floor Hazardous Drug Compounding Room 1118 Contract Period: Option 1 POP Begin: 01-01-2026 POP End: 12-31-2026

Semi-annual (January and July) Certifications at 9th floor Hazardous Drug Compounding Room 970

POP Begin: 01-01-2026 POP End: 12-31-2026

Monthly Surface Sampling for Pharmacy Locations. (Include all the below for each of 12 Months)

POP End: 12-31-2026

Pharmacy Compounding Aseptic Isolator (CAI); One-time Certification outside of the normal January July certification window.

POP Begin: 01-01-2026 POP End: 12-31-2026

Pharmacy Laminar Airflow Workbench (LAFW); One-time Certification of 2 units outside of normal January/July certification window.

POP Begin: 01-01-2026 POP End: 12-31-2026

Genus Speciation of sampling detections.

POP Begin: 01-01-2026 POP End: 12-31-2026

One-time Decontamination for preparation to turn in. Research area Building 1.

POP Begin: 01-01-2026 POP End: 12-31-2026

Semi-Annual (January and July) Certifications Services for Research Areas Building 1 and Building 229.

POP End: 12-31-2026

: Semi-Annual (January and July) Certifications Services for Laboratory/Pathology Medicine Areas Building 1 and Building 200.

POP Begin: 01-01-2026 POP End: 12-31-2026

Semi-Annual (January and July) Certifications Services for Surgery Building 200.

POP Begin: 01-01-2026 POP End: 12-31-2026

Semi-Annual (January and July) Certifications at 1st floor Main IV Room B109F (including ante room and airlock).

Contract Period: Option 2 POP Begin: 01-01-2027 POP End: 12-31-2027

Semi-Annual (January and July) Certifications at 11th floor Hazardous Drug Compounding Room 1118 Contract Period: Option 2 POP Begin: 01-01-2027 POP End: 12-31-2027

Semi-annual (January and July) Certifications at 9th floor Hazardous Drug Compounding Room 970

POP Begin: 01-01-2027 POP End: 12-31-2027

Monthly Surface Sampling for Pharmacy Locations. (Include all the below for each of 12 Months)

POP End: 12-31-2027

Pharmacy Compounding Aseptic Isolator (CAI); One-time Certification outside of the normal January July certification window.

POP Begin: 01-01-2027 POP End: 12-31-2027

Pharmacy Laminar Airflow Workbench (LAFW); One-time Certification of 2 units outside of normal January/July certification window.

POP Begin: 01-01-2027 POP End: 12-31-2027

Genus Speciation of sampling detections.

POP Begin: 01-01-2027 POP End: 12-31-2027

One-time Decontamination for preparation to turn in. Research area Building 1.

POP Begin: 01-01-2027 POP End: 12-31-2027

Semi-Annual (January and July) Certifications Services for Research Areas Building 1 and Building 229.

POP End: 12-31-2027

: Semi-Annual (January and July) Certifications Services for Laboratory/Pathology Medicine Areas Building 1 and Building 200.

POP Begin: 01-01-2027 POP End: 12-31-2027

Semi-Annual (January and July) Certifications Services for Surgery Building 200.

POP Begin: 01-01-2027 POP End: 12-31-2027

Semi-Annual (January and July) Certifications at 1st floor Main IV Room B109F (including ante room and airlock).

Contract Period: Option 3 POP Begin: 01-01-2028 POP End: 12-31-2028

Semi-Annual (January and July) Certifications at 11th floor Hazardous Drug Compounding Room 1118 Contract Period: Option 3 POP Begin: 01-01-2028 POP End: 12-31-2028

Semi-annual (January and July) Certifications at 9th floor Hazardous Drug Compounding Room 970

POP Begin: 01-01-2028 POP End: 12-31-2028

Monthly Surface Sampling for Pharmacy Locations. (Include all the below for each of 12 Months)

POP End: 12-31-2028

Pharmacy Compounding Aseptic Isolator (CAI); One-time Certification outside of the normal January July certification window.

POP Begin: 01-01-2028 POP End: 12-31-2028

Pharmacy Laminar Airflow Workbench (LAFW); One-time Certification of 2 units outside of normal January/July certification window.

POP Begin: 01-01-2028 POP End: 12-31-2028

Genus Speciation of sampling detections.

POP Begin: 01-01-2028 POP End: 12-31-2028

One-time Decontamination for preparation to turn in. Research area Building 1.

POP Begin: 01-01-2028 POP End: 12-31-2028

Semi-Annual (January and July) Certifications Services for Research Areas Building 1 and Building 229.

POP End: 12-31-2028

: Semi-Annual (January and July) Certifications Services for Laboratory/Pathology Medicine Areas Building 1 and Building 200.

POP Begin: 01-01-2028 POP End: 12-31-2028

Semi-Annual (January and July) Certifications Services for Surgery Building 200.

POP Begin: 01-01-2028 POP End: 12-31-2028

Semi-Annual (January and July) Certifications at 1st floor Main IV Room B109F (including ante room and airlock).

Contract Period: Option 4 POP Begin: 01-01-2029 POP End: 12-31-2029

Semi-Annual (January and July) Certifications at 11th floor Hazardous Drug Compounding Room 1118 Contract Period: Option 4 POP Begin: 01-01-2029 POP End: 12-31-2029

Semi-annual (January and July) Certifications at 9th floor Hazardous Drug Compounding Room 970

POP Begin: 01-01-2029 POP End: 12-31-2029

Monthly Surface Sampling for Pharmacy Locations. (Include all the below for each of 12 Months)

POP End: 12-31-2029

Pharmacy Compounding Aseptic Isolator (CAI); One-time Certification outside of the normal January July certification window.

POP Begin: 01-01-2029 POP End: 12-31-2029

Pharmacy Laminar Airflow Workbench (LAFW); One-time Certification of 2 units outside of normal January/July certification window.

POP Begin: 01-01-2029 POP End: 12-31-2029

Genus Speciation of sampling detections.

POP Begin: 01-01-2029 POP End: 12-31-2029

One-time Decontamination for preparation to turn in. Research area Building 1.

POP Begin: 01-01-2029 POP End: 12-31-2029

Semi-Annual (January and July) Certifications Services for Research Areas Building 1 and Building 229.

POP End: 12-31-2029

: Semi-Annual (January and July) Certifications Services for Laboratory/Pathology Medicine Areas Building 1 and Building 200.

POP Begin: 01-01-2029 POP End: 12-31-2029

Semi-Annual (January and July) Certifications Services for Surgery Building 200.

POP Begin: 01-01-2029 POP End: 12-31-2029

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

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

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

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

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

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

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

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

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

(g) Invoice.

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

(i) Name and address of the Contractor;

(ii) Invoice date and number;

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

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

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