S02 36C24924Q0049 Cleanroom Certification.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36C24924Q0049 11-07-2023

Michael McCarthy 615-225-6889 11-17-2023

10AM CST

Department of Veterans Affairs Network Contracting Office 9 (90C)

NCO 9

1639 Medical Center Parkway, Suite 200 Murfreesboro TN 37129

X 100

X

541690

$19 Million

N/A

X

NCO - 9

3400 Lebanon Pike

Murfreesboro TN 37129

90C

Network Contracting Office 9 Department of Veterans Affairs Network Contracting Office (90C) 1639 Medical Center Parkway Suite 200 00 Murfreesboro TN 37129

90C

FSC e-Invoicing Payment http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 Invoice must be submitted electronically

Setup 1-877-489-6135

See CONTINUATION Page

James H. Quillen VA Medical Center Cleanroom Testing and Certification

The Period of Performance: 12/01/2023 to 11/30/2024.

This is a Small Business Set A Side Vendors must be active in SAM.gov to be eligible to submit a quote.

Wage Determination 2015-4641 R. 20 D. 8/4/2023 applies.

See CONTINUATION Page

X X

X 1

36C24924Q0049

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

STATEMENT OF WORK (SOW)

A - GENERAL INFORMATION

B – WORK REQUIREMENTS

D – SPECIAL CONSIDERATIONS:

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (DEC 2022)

C.2 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.3 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.4 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.5 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)

C.6 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.7 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (SEP 2023)

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

1998)

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.4 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (SEP 2023)

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 36C249

Network Contracting Office 9 (90C)

NCO 9

1639 Medical Center Parkway, Suite 200 Murfreesboro TN 37129

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award

Management, or [X] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] In Arrears

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

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

AMENDMENT NO DATE

B.2 STATEMENT OF WORK

STATEMENT OF WORK (SOW)

A - GENERAL INFORMATION

A.1 INTRODUCTION – The Food and Drug Administration (FDA) has the authority to inspect VA medical facilities and the Joint Commission (TJC) establishes compounding standards for sterile compounded preparations based on the United States Pharmacopeia (USP) standards.

The USP establishes standards for sterile compounding room design, environmental monitoring, and competencies for the preparation, handling, and storage of compounded sterile products (CSPs).

To meet regulatory requirements in accordance with USP <797> and USP <800>, the James H.

Quillen VA Medical Center (JHQVAMC) requires certification of primary engineering controls (PECs), secondary engineering controls (SECs), and testing of compounding personnel for aseptic technique by gloved fingertip and thumb sampling, media fill testing and hazardous drug testing.

A.2 SCOPE OF WORK – The Contractor will provide all parts, labor, equipment, material, travel expenses to test and certify the operation and performance of equipment systems and personnel per the Statement of Work listed below. The effort on this project shall be a one-year contract base to properly support the hospital staff at James H. Quillen VA Medical Center. The Period of Performance shall be 12/01/2023 to 11/30/2024.

B – WORK REQUIREMENTS

B.1 TASKS TO BE ACCOMPLISHED:

a. All work must be conducted, coordinated, and scheduled based on the needs of the Pharmacy Service. The testing of the Sterile Compounding Suites and equipment must be conducted during dynamic operating conditions to assure smooth even flow across the DCA and out to the returns. In the presence of the Compounded Sterile Products Manager and Hazardous Drugs Program Manager.

b. The Contractor may be notified at a minimum of 2 business days to a maximum of 5 business days and must respond and be available on site to perform testing/retesting within the specified time frame.

c. The Contractor will provide a Qualified Tester and appropriate tools/test equipment to complete the work as covered in Section C.3.

d. Due to the sensitive nature of the work area, prior to entering sterile compounding areas (buffer room, ante room), the Contractor will maintain a clean work area at all times by wearing appropriate personal protective equipment (set forth by USP <797> standards) and cleaning any equipment with 70% sterile isopropyl alcohol.

e. The Contractor will test each PEC and SEC according to Certification Guide for Sterile Compounding Facilities (CETA) and USP <797> regulations every six months.

f. The Contractor will provide JHQVAMC with the original certification documents that includes all measurements and results of each PEC and SEC. Certification should include identifying information of each PEC and SEC as well as all test equipment used for certification. See Section B for specific requirements.

g. The Contractor will immediately notify identified points of contact (POC) with any results indicating failure.

h. A formalized written report including all required aspects specified in this statement of work will be provided in a timely manner by email with receipt by identified POC no more than 10 business days from certification evaluation.

i. Any failure of engineering controls to meet required specifications shall be clearly marked with a sign that will notify pharmacy staff.

B.2 PRIMARY ENGINEERING CONTROLS (PECs) TO CERTIFY

a. PEC tested and certified according to CETA and IEST guidelines, and to manufacturer’s specifications.

b. Within DCA with a NIST traceable or comparable calibrated piece of equipment (calibrated within past 12 months) to perform all testing and provide copies of the calibration tests to the POC. Calibration records will be supplied in report.

c. The Contractor shall report each individual face velocity reading and the average of those readings, the downstream concentration ready of the HEPA filter leak test and the results of the induction leak test and backstreaming test.

d. The Contractor will provide and label with a certification sticker that contains the following: company name, phone number, PEC model and serial number, service number, certification date, recertification date, certifiers signature.

e. Total particle count testing must be performed under dynamic operating conditions using calibrated electronic equipment. Documentation of test results must also include the number of personnel present in each PEC during testing.

f. Viable Air Sampling shall be conducted with high volume impaction samplers to conduct the sampling of a sufficient volume of air (1000 liters) at each specified location. The reports shall indicate site locations, volume of air sampled, media manufacturer, lot #, expiration date, incubation start date & time, number of CFU’s with locations, identification of CFU’s, date & time of sample results.

g. Viable Surface Sampling reports to indicate site locations, media manufacturer, lot #, expiration date, incubation start date & time, number of CFU’s with locations, identification of CFU’s, date & time of sample results and the person reading the results.

h. Documentation of the smoke study results shall include the number of personnel present in the PEC during the dynamic airflow smoke pattern test.

Line Item

Description Qty Frequency per Year

Qty per Year

1 8’ BVBI-8SSRX Laminar Vertical Flow Workstation ISO Class 5, Building 77 Room FA126A

1 2 2

2 6’ BBF-6SS Biological Safety Cabinet Class II Type A ISO Class 5, Building 77 Room J140A

1 2 2

3 3’ BBF-3SSRX Biological Safety Cabinet Class II Type A ISO Class 5, Building 77 Room

1 2 2

4 4’ BZ-4SSRX Laminar Vertical Flow Workstation ISO Class 5, Building 77 Room

1 2 2

B.2A SERVICES TO BE PERFORMED FOR PECs

Line Item

Description Qty Frequency per Year

Qty per Year

1 Total particle count testing under dynamic operating conditions using calibrated electronic equipment for each of the listed PECs.

7 or more

2 varies

2 Viable Air Sampling number and location as determined by the Contractee (bacterial and fungal samples)

8 or more

2 varies

3 Viable Surface Sampling number and location as determined by the Contractee (bacterial and fungal samples)

12 or more

12 varies

4 Both static and dynamic smoke studies verifying a continuous flow of HEPA filtered air void of turbulence, dead air zones, and refluxing from the HEPA filters to and across the entire work area and to the air returns must be performed and documented by video. Video of dynamic smoke test must document the demonstration of unidirectional airflow and sweeping action over and away from the preparation(s). Contractor to leave video of smoke test on site prior to completion of certification process for each of the listed PECs.

4 2 8

5 HEPA filter leak test 4 2 8

6 Cabinet leak test 4 2 8

7 Inflow velocity test to include exhaust airflow volume rate

4 2 8

8 Electrical leakage and ground circuit resistance and polarity tests

4 2 8

9 Lighting intensity test 4 2 8

10 Vibration test 4 2 8

11 Noise level test 4 2 8

12 Ultraviolet (UV) lamp test 4 2 8

13 Airflow testing under dynamic conditions to include air velocity and volume, the air exchange rate.

4 2 8

14 Hazardous drug contamination to include cyclophosphamide, ifosfamide, methotrexate, fluorouracil, taxanes, and platinum-containing drugs. Additional drugs may be requested.

12 2 24

B.3 SECONDARY ENGINEERING CONTROLS (SECs) TO CERTIFY

a. The Contractor shall calculate the total room volume for each buffer, ante room, and hazardous drug storage room.

b. A sketch of the room with dimensions, exhaust/supply diffuser locations and equipment locations shall be included in the report.

c. The report provided will specify flow rates detailing returns and supply that were obtained during the testing.

d. The contractor shall calculate air changes per hours (ACPH) from HVAC, ACPH contributed from the PEC, and the total ACPH for each buffer, ante room, and storage room shall be documented on the certification report.

e. Total particle count testing must be performed under dynamic operating conditions using calibrated electronic equipment. Documentation of test results must also include the number of personnel present in each SEC during testing.

f. Viable Air Sampling shall be conducted with high volume impaction samplers to conduct the sampling of a sufficient volume of air (1000 liters) at each specified location. The reports shall indicate site locations, volume of air sampled, media manufacturer, lot #, expiration date, incubation start date & time, number of CFU’s with locations, identification of CFU’s, date & time of sample results.

g. Viable Surface Sampling reports to indicate site locations, media manufacturer, lot #, expiration date, incubation start date & time, number of CFU’s with locations, identification of CFU’s, date & time of sample results.

h. Hazardous drug contamination sampling report to include manufacturer, lot #, and expiration date of sampling kit, sample site locations, name of products tested for, and results.

Line Item

Description Qty Frequency per Year (minimum)

Qty per Year (minimum)

1 Non-Hazardous IV Anteroom Certification ISO Class 8, Building 77 Room FA126

1 2 2

2 Non-Hazardous IV Buffer Room Certification ISO Class 7, Building 77 Room FA126A

1 2 2

3 Hazardous IV Anteroom Certification ISO Class 7, Building 77 Room J140

1 2 2

4 Hazardous IV Buffer Room Certification ISO Class 7, Building 77 Room J140A

1 2 2

5 Hazardous Drug Storage Room Building 77 Room J139

1 2 2

6 Contained Segregated Compounding Area Building 77 Room G101

1 2 2

B.3A SERVICES TO BE PERFORMED FOR SECS

Line Item

Description Qty Frequency per Year (minimum)

Qty per Year (minimum)

1 Total particle count testing under dynamic operating conditions using calibrated electronic equipment, for the SECs

7 or more

2 varies

2 Viable Air Sampling number and location as determined by the Contractee (bacterial and fungal samples)

8 or more

2 varies

3 Viable Surface Sampling number and location as determined by the Contractee (bacterial and fungal samples) locations or more

Monthly at the same time as

MFT.

varies

4 HEPA filter integrity testing for listed SECs

2 14

5 Airflow profiling and uniformity testing for listed SECs

2 2

6 Particulate monitoring For listed SECs

2 2

7 Room pressurization monitoring For listed SECs

2 2

8 Temperature and Humidity monitoring For listed SECs

2 2

9 Air pattern analysis For listed SECs

2 2

10 Airflow testing under dynamic conditions to include air velocity and volume, the air exchange rate, and the room pressure differential in doorways between adjacent rooms.

For listed SECs

2 2

11 Hazardous drug sampling to include:

cyclophosphamide, ifosfamide, methotrexate, fluorouracil, taxanes, and platinum-containing drugs. Additional drugs may be requested.

12 2 24

C – SUPPLEMENTAL TESTING

1. Media Fill Testing will occur in Laminar Vertical Flow Workstation in Building 77 Room FA126A and simulate the most difficult and challenging compounding procedures and processing conditions encountered by the person replacing all the components used in the CSPs with soybean–casein digest media.

2. A certificate of analysis (COA) must be provided if commercial sterile microbial growth media is used for the media fill testing.

3. Media Fill Testing will occur prior to gloved fingertip and thumb testing for recertification.

4. The Contractor shall incubate media fill tests in controlled temperature environments in accordance with USP <797> guidance (and <800>).

5. Documentation of the media fill test will include the name of the person evaluated, evaluation date/time, media and components used, including manufacturer, expiration date and lot number, starting temperature for each interval of incubation, dates of incubation, the results, and the identification of the observer and the person who reads and documents the results.

6. The Contractor shall perform three separate gloved fingertip and thumb tests during initial testing (one sampling device per hand) for each designated employee.

Subsequent sampling shall occur every 6 months for personnel that compound and every 12 months for personnel that have oversight of compounding personnel.

7. Gloved fingertip and thumb samples shall be performed in controlled temperature environments and incubated in accordance with USP <797> and <800> guidance.

8. Each sample shall be labeled with a personnel identifier, whether it was from the right or left hand, and the date and time of sampling.

9. Documentation results for gloved fingertip and thumb sampling will include the name of the person evaluated, evaluation date/time, media and components used, including manufacturer, expiration date and lot number, starting temperature for each interval of incubation, dates of incubation, the results, and the identification of the observer and the person who reads and documents the number of colony forming units (CFU) for the left and right hand.

Line Item

Description Qty Frequency per Year

Qty per Year (minimum)

1 Media Fill Testing with surface sampling of the direct compounding area immediately after

65 total tests distributed throughout the year

12(monthly) 65

2 Gloved Fingertip and thumb testing 65 total tests distributed throughout the year

12(monthly) 65

3 Additional New Employee Media Fill and Gloved Fingertip and thumb testing

Up to 10 total new hires distributed

12(monthly) 10 through the year.

D – SPECIAL CONSIDERATIONS:

D.1 Place of Performance: James H. Quillen VA Medical Center, Corner of Lamont and Veterans Way, Johnson City, Tennessee 37601

D.2 Contractor Furnished Materials: All labor, materials, equipment to perform the job.

When “furnish”, “provide”, “install”, or similar term is used it shall mean a complete installation, ready for use. The Contractor shall supply all parts that is currently not covered under warranty, equipment, material and labor to conduct work as listed in the Statement of Work above. The work will include all items as described in the Scope of Work listed above.

D.3 Government Furnished Materials and Services: Government furnished property, if any, will be identified and will only be used for the performance of this contract unless otherwise authorized by the Contracting Officer. The Contractor shall, at all times, take any and all steps necessary for maintenance and preservation of all Government-furnished property. The Contractor shall comply with all reasonable requests of the Contracting Officer to enclose, or specifically protect, Government-furnished property.

D.4 Qualifications of Key Personnel: The Contractor will provide three references for showing the completion of at least three jobs of similar size and scope at other hospital facilities with at least one of those facilities being a VA Medical Center, in addition will also provide three references for each Qualified Tester that performs work at JHQVAMC. The Contractor’s Qualified Tester must possess current CETA, NSF and CNBT Certification for Sterile Compounding Facilities. The Contractor will provide copies of the Qualified Tester’s accreditation prior to conducting certification.

D.5 Other Requirements: The Contract will provide sample reports of prior certification reports from other contracted Sterile Compounding Suites certifications include Primary and Secondary Engineering Controls. The sample reports should include the calibration reports of equipment used to certify the Sterile Compounding Suites.

D.6 Security Requirements: Contractor shall identify which employees will be working under the awarded contract. Contractor personnel shall include employees, sub-contractors, subcontractor employees, suppliers and delivery personnel entering the Medical Center. This does not apply to suppliers and delivery personnel making deliveries to the VA warehouse dock only. Those employees shall bring photo ID to obtain a VA Contractor identification badge that shall be worn above the belt at all times while on Medical Center property. Contractor’s employees shall return all I.D. badges to designated personnel at time designated in the task order.

D.7 Inspection of Work:

a. The COR is responsible for the inspection of the work called for in this job. The Contracting Officer’s Representative will be identified in the task order by name, telephone number and location. Inspections made by the COR are for the sole benefit of the Government and do not relieve the Contractor of any quality control responsibilities.

b. The Contractor will be notified by the Contractee of any updates to identified points of contact list on an as needed basis and in turn the Contractor will provide the Contractee with any updates.

D.8 Safety: The Safety Manger is responsible for safety inspections of all contract operations. The Safety Manager will be identified in the task order by name, phone number and location.

D.9 Drawings General: Contract drawings (if applicable) will indicate the extent and location of work. If any departure from the contract drawings are deemed necessary by the Contractor, the details of such departure and the reasons therefore shall be submitted to the Contracting Officer for approval as soon as practical. No such departure shall be made without proper written permission of the Contracting Officer. The Contractor is responsible for all information and requirements in drawings and specifications that pertain to the task order.

D.10 Verification of Dimensions: The Contractor shall visit the job site to thoroughly familiarize themselves with all the details of the work and working conditions. The Contractor shall also verify all dimensions in the field and shall advise the Contracting Officer of any discrepancy before performing any work. The Contractor shall be specifically responsible for the coordination and proper relation of their work to the building, structure, phasing and ensure the safety of employees and workmen.

D.11 Smoking Policy: The Contractor shall ensure employees do no smoke on the VA grounds as JHQVAMC is a smoke-free facility.

D.12 Parking/Traffic Regulations: The Contractor shall not park on grassy areas unless approved by the COR and the Contractor agrees to restore areas back to VA standards.

Drivers should be particularly concerned with pedestrian traffic. Yield to pedestrians in crosswalks. Posted speed limits and all other traffic controls are to be observed by operators at all times. Seat belt use is mandatory on the VA grounds.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

2.00 EA __________________ __________________

Cleanroom certifications for two (2) ISO classified Anterooms, one

(1) Non-Hazardous IV Buffer Room, one (1) Hazardous Drug Buffer Room. Airflow and room pressurization testing for one (1) non-classified hazardous drug storage room, one (1) SCA, and one (1) C-

SCA.

Hazardous Drug Wipe Testing

260.00 EA __________________ __________________

Personnel Testing

Quarterly Surface Sampling

GRAND TOTAL __________________

SECTION C - CONTRACT CLAUSES

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

PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

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

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

and

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

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

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

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

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

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

(g) Invoice.

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

(i) Name and address of the Contractor;

(ii) Invoice date and number;

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

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

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

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

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

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

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

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

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

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

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

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

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

(i) Payment.—

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

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

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

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

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

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

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

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

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

(D) Contractor point of contact.

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

(6) Interest.

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

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

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

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

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

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

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

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

(A) The date fixed under this contract.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 4701 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

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

(1) The schedule of supplies/services.

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

(3) The clause at 52.212-5.

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

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

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

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

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause)

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.2 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT

REQUESTS (NOV 2018)

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001;

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests;

(4) Invoice payment has the meaning given in FAR 32.001; and

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System at the current website address provided in the contract.

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National Standards Institute (ANSI).

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances in this paragraph (e), the Contracting Officer directs that payment requests be made by mail, the Contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office.

Submission of payment requests by mail may be required for—

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

(End of Clause)

C.3 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

FAR

Number

Title Date

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

(End of Clause)

AUG 2020

C.4 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

The Contractor shall not make reference in its commercial advertising to Department of Veterans Affairs contracts in a manner that states or implies the Department of Veterans Affairs approves or endorses the Contractor’s products or services or considers the Contractor’s products or services superior to other products or services.

(End of Clause)

C.5 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)

(a) The offeror agrees, if awarded a contract, to use the service-disabled veteran-owned small businesses (SDVOSBs) or veteran-owned small businesses (VOSBs) proposed as subcontractors in accordance with 852.215–70, Service-Disabled Veteran-Owned and Veteran- Owned Small Business Evaluation Factors, or to substitute one or more SDVOSBs or VOSBs for subcontract work of the same or similar value.

(b) Pursuant to 38 U.S.C. 8127(g), any business concern that is determined by VA to have willfully and intentionally misrepresented a company’s SDVOSB/VOSB status is subject to debarment for a period of not less than five years. This includes the debarment of all principals in the business.

(End of Clause)

FAR

Number

Title Date

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

C.6 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC

2022) The Contracting Officer reserves the right to designate representatives to act for him/her in furnishing technical guidance and advice or generally monitor the work to be performed under this contract. Such designation will be in writing and will define the scope and limitation of the designee’s authority. A copy of the designation letter shall be furnished to the Contractor.

(End of Clause)

(End of Addendum to 52.212-4)

C.7 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (SEP 2023)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204–23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (NOV 2021) (Section 1634 of Pub. L.

115–91).

(3) 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115–232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.232–40, Providing Accelerated Payments to Small Business Subcontractors (MAR 2023) (31 U.S.C. 3903 and 10 U.S.C. 3801).

(6) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(7) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

[X] (1) 52.203–6, Restrictions on Subcontractor Sales to the Government (JUN 2020), with Alternate I (NOV 2021) (41 U.S.C. 4704 and 10 U.S.C. 4655).

[] (2) 52.203–13, Contractor Code of Business Ethics and Conduct (NOV 2021) (41 U.S.C.

3509).

[] (3) 52.203–15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

[X] (4) 52.204–10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109–282) (31 U.S.C. 6101 note).

[] (5) [Reserved]

[] (6) 52.204–14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[] (7) 52.204–15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[X] (8) 52.204–27, Prohibition on a ByteDance Covered Application (JUN 2023) (Section 102 of Division R of Pub. L. 117–328).

[X] (9) 52.209–6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (NOV 2021) (31 U.S.C. 6101 note).

[] (10) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters

(OCT 2018) (41 U.S.C. 2313).

[] (11) [Reserved]

[] (12) 52.219–3, Notice of HUBZone Set-Aside or Sole-Source Award (OCT 2022) (15 U.S.C. 657a).

[] (13) 52.219–4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

[] (14) [Reserved]

[X] (15)(i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).

[] (ii) Alternate I (MAR 2020) of 52.219-6.

[] (16)(i) 52.219-7, Notice of Partial Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).

[] (ii) Alternate I (MAR 2020) of 52.219-7.

[] (17) 52.219-8, Utilization of Small Business Concerns (SEP 2023) (15 U.S.C. 637(d)(2) and (3)).

[] (18)(i) 52.219–9, Small Business Subcontracting Plan (SEP 2023) (15 U.S.C. 637(d)(4)).

[] (ii) Alternate I (NOV 2016) of 52.219-9.

[] (iii) Alternate II (NOV 2016) of 52.219-9.

[] (iv) Alternate III (JUN 2020) of 52.219–9.

[] (v) Alternate IV (SEP 2023) of 52.219–9.

[] (19)(i) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) (15 U.S.C. 644(r)).

[] (ii) Alternate I (MAR 2020) of 52.219-13.

[] (20) 52.219–14, Limitations on Subcontracting (OCT 2022) (15 U.S.C. 657s).

[] (21) 52.219-16, Liquidated Damages—Subcontracting Plan (SEP 2021) (15 U.S.C.

637(d)(4)(F)(i)).

[] (22) 52.219–27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (OCT 2022) (15 U.S.C. 657f).

[X] (23) (i) 52.219–28, Post-Award Small Business Program Rerepresentation (SEP 2023) (15 U.S.C. 632(a)(2)).