36C24823Q1615.docx

SUBJECT*

FY23: Biohood and Clean Room Inspection and Certification Service

GENERAL INFORMATION

Network Contracting Office 8 (NCO 8)

10,000 Bay Pines Blvd Bay Pines FL 33744

POINT OF CONTACT*

PLACE OF PERFORMANCE

C. W. Bill Young VA Medical Center

10000 Bay Pines Blvd

Bay Pines Florida

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

Service: Chem. Biohood and Clean Room Inspection and Certification Service

Contractor to provide inspection, service, certification for biological safety cabinets, TB isolation rooms, general isolation rooms, separative enclosures, and glove boxes, all Pharmacy (PEC) devices and (SEC) classified air space rooms and segregated compounding areas. Testing will take place at the C. W. Bill Young VA Medical Center, 10000 Bay Pines Blvd, Bay Pines, FL 33744 and at the Lee County VA Healthcare Center, 2489 Diplomat Parkway East, Cape Coral, FL 33909.

Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice

Combined Synopsis/Solicitation Notice

Request for Quotes: 36C24823Q1615 General Information

Contracting Office Address

NCO 8

ATTN: John Hamilton 10000 Bay Pines Blvd Bay Pines, FL 33744 Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 in conjunction with Part 13, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation for this action. Quotes are being requested, and a written solicitation will not be issued.

This solicitation is issued as a Request for Quote (RFQ). Submit written quotes on 36C24823Q1615. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2023-04 effective June 2, 2023. This request for quote is issued July 21, 2023 and will end on August 11, 2023 at 3:00 PM EST and is Set-Aside for 100% Small Business.

The Network Contracting Office 8-RPO East intends to award a firm fixed priced contract to the contractor providing a Base Year and 4 Option Years service to provide inspection, service, certification for biological safety cabinets, TB isolation rooms, general isolation rooms, separative enclosures, and glove boxes, all Pharmacy (PEC) devices and (SEC) classified air space rooms and segregated compounding areas. Testing will take place at the C. W. Bill Young VA Medical Center, 10000 Bay Pines Blvd, Bay Pines, FL 33744 and at the Lee County VA Healthcare Center, 2489 Diplomat Parkway East, Cape Coral, FL 33909.

All the work will be in accordance with the Statement of Work below.

This procurement is being conducted under Subpart 13.5 Simplified Procedures for Certain Commercial items. The intent is to award a firm fixed price contract.

This procurement is a 100% Small Business set-aside and all eligible offerors are encouraged to submit quotes. To be considered for award prospective offerors must be a verified Small Business (if applicable) or if SDVOSB and VOSB concern in the VA Center for Verification and Evaluation (CVE) Veteran Information Pages (VIP) pages https://www.vip.vetbiz.gov/ at the date and time set for receipt of offers. An Offeror who is not a verified SDVOB or VOSB concern at the date and time set for receipt of offers will be considered Small Business to be considered for award. All offerors must be registered in System for Award Management (SAM) at http://www.sam.gov to be considered for an award of a federal contract registered in the record must be complete and not missing elements such as representations and certifications.

Contractors interested in providing these services should submit their quotes via email to john.hamilton2@va.gov.

A Multiple Location Site Visits: are scheduled on Wednesday, July 26, 2023.

1st Location will Start: at 9:00 AM EST at the Lee County VA Healthcare Center, Main Campus. 2489 Diplomat Parkway East, Cape Coral, Florida 33909.

ALL VENDORS WILL REPORT AND SIGN IN FRONT OF NORTH ENTRANCE MAIN BUILDING NO LATER THAN 9:00 A.M. EST, PRIOR TO CHECKING IN AT THE POLICE DISPATCH WINDOW AND PROCEEDING TO THE SITE VISIT.

2nd Location will start at 1:00 PM EST on the Bay Pines VA Main Campus. 10000 Bay Pines Blvd, Bay Pines, Florida 33744. Interested contractors shall meet at Main Lobby Building 100, NO LATER THAN 1 PM EST, BEFORE PROCEEDING TO THE SITE VISIT.

The site visit is very and highly encouraged and expected prior to submission of quote.

Contractors are required to contact John Hamilton at (727) 685-9175, or john.hamilton2@va.gov to sign up for the site visit.

All questions regarding this RFQ must be in writing and may be sent by email to john.hamilton2@va.gov Questions must be received no later than Monday, July 31, 2023 at 1:00 P.M, EST. No further questions will be accepted after this date and time.

ANSWERS TO VENDOR QUESTIONS: Answers to vendor question will be posted on FBO no later than Thursday, August 3, 2023 by 4:30 P.M. EST.

You are reminded that representatives from your company SHALL NOT contact any Bay Pines VA Healthcare System personnel to discuss this RFQ during the RFQ process. All questions and concerns regarding this RFQ shall be directed to the Contracting Officer.

Quotes are due by 3:00 PM Eastern Standard Time on Friday, August 11, 2023. Quotes received after this date and time will be considered late in accordance with 52.212-1(f) and will not be evaluated. Quotes shall be submitted via email to john.hamilton2@va.gov.

B. Schedule of Services:

Contractors shall quote prices using Attachment A for all of the following Contract Line Item Numbers listed in ELIN List Spreadsheet.

C. Statement of Work Statement of Work Service: CERTIFICATION, ROUTINE TESTING AND MAINTENANCE OF TB ISOLATION ROOMS AND EQUIPMENT, BIOLOGICAL SAFETY CABINETS, ROOMS AND EQUIPMENT USED BY PHARMACY TO PREPARE COMPOUNDED STERILE PRODUCTS (CSP).

1. GENERAL SCOPE

Certification, maintenance and service of TB isolation rooms and equipment, biological safety cabinets, and/ or all primary engineering control (PEC) devices (laminar airflow workbenches (LAFW), compounding aseptic containment isolators and secondary engineering controls (SEC) (i.e. cleanroom, anterooms) used for compounded sterile product preparation, are installed and maintained to meet all regulatory requirements.

1. Scope of Work: The contractor shall provide inspection, service and certification for biological safety cabinets, TB isolation rooms, general isolation rooms, separative enclosures and glove boxes, all Pharmacy (PEC) devices and (SEC) classified air space rooms and segregated compounding areas All areas and equipment used in compounding sterile products must meet requirements as specified in USP Chapter 797 Pharmaceutical Compounding -Sterile Preparations, USP Chapter 800 Hazardous Drugs- Handling in Healthcare Settings. and VHA Directive 1108.12 Management and Monitoring of Pharmaceutical Compounded Sterile Preparations. All vendors used to conduct primary and secondary engineering controls, as well as employee certifications/ assessments for rooms and devices used in preparation of CSP must be registered with Controlled Environment Testing Association (CETA). Contractor must perform field verification of all hoods and rooms and submit in writing within 30 business days to CO/COR.

1. Background: The current vendor performs semi-annual certification of all biological safety cabinets and negative pressure isolation rooms on an as-needed basis, as well as periodic decontamination and maintenance/repair of biological safety cabinets. All PECs and SECs used in preparation of CSP are also certified on a semi-annual basis. In addition, nonviable airborne monitoring and microbiological (viable) air and surface monitoring, as well as annual/semi-annual employee evaluations are performed in accordance with current USP 797.

1. Performance Location and Hours Testing will take place at the C.W. Bill Young VAMC, 10000 Bay Pines Blvd, Bay Pines, FL 33744 and at LCHCC, 2489 Diplomat Parkway East, Cape Coral, FL 33909. Testing will take place during normal business hours 0800 – 1630 Monday through Friday, excluding Federal holidays. When necessary, contractor will be provided access 0600- 2100 C.W. Bill Young VAMC to enable testing of staff working second and third shifts. In the event that an emergency repair is necessary, Contractor will be provided access on Saturday and Sundays.

1. CONTRACT AWARD MEETING

The contractor shall not commence performance on the tasks in this SOW until the CO has conducted a kick-off meeting or has advised the contractor that a kick-off meeting is waived.

1. GENERAL REQUIREMENTS

2. Inspection and testing of all HEPA exhaust units designated for tuberculosis (TB) control shall be conducted semi-annually. Each HEPA exhaust unit, Laminar Flow hood, or Biological Safety Cabinet (BSC) shall be certified six (6) months following previous certification.

2. Pre-filter changes/inspections in the Pharmacy shall be conducted monthly. Microbial testing for mold and yeast in Pharmacy will be done in according with USP 797 and CETA Certification Application Guides.

2. Certification and maintenance of PECs and SECs used in preparation of CSP to meet USP 797/800 and VHA Directive 1108.12 standards

2. Inspections and testing shall be scheduled with the COR a minimum of three (3) working days in advance. There is potential difficulty in accessing some HEPA units due to the nature of patient care activities; therefore, close coordination with the COR is necessary. Contractor will be responsible for ensuring all certifications are completed within the required time frame (semi-annually) for all hoods and HEPA units.

2. Inspections shall consist of a complete check of equipment, making all necessary adjustments, alignments, cleaning, lubrication, performance testing and calibration to ensure equipment meets or exceeds manufacturers' original specifications available in manuals on site.

2. Any work requiring decontamination of Equipment/Components shall be performed with Hydrogen Peroxide Vapor decontamination.

2. The vendor shall refer to the most current versions of standards including but not limited to USP, FDA and CETA when conducting the requested monitoring and reporting. The frequencies of testing and specific procedure should be determined by the most updated version of CETA, USP <797> and <800>, and per specific facility requirements and/or requests. The vendor shall be responsible for complying with the most updated versions of this guidance and will conduct all sampling per the procedures outlined within the official chapters.

2. Gowning and Garbing Evaluation: The Vendor shall perform a gowning and garbing evaluation for each employee in conjunction with the gloved fingertip and thumb sampling, media-fill test, and surface sampling of the direct compounding area (DCA) following media fill testing. The vendor shall use the facility’s standard operating procedure and USP <797> as guidance for their evaluation.

2. Gloved fingertip and thumb sampling: The Vendor shall perform the gloved fingertip and thumb sampling for the expected number of employees from each facility as listed in appendix A. This should be done in conjunction with media-fill testing and DCA surface sampling. The results should be reported by number of colony-forming units (CFU) per hand (left hand, right hand). If any agar plates demonstrate growth, the preliminary results will be reported to the CO/COR, to the Chief, Pharmacy Service and to the Compounded Sterile Products Program Manager, Pharmacy Service as soon as the initial results are known. Final results will be expeditiously reported after further antimicrobial testing is complete.

2. Media-Fill Testing: The Vendor shall perform media-fill testing for the expected number of employees from each facility as listed in appendix A. This should be done in conjunction with gloved fingertip and thumb sampling and DCA surface sampling. The results should include the name of the employee evaluated, the evaluation date/time, media and components used to include the expiration date and lot number, the results, and the signatures of the person evaluated and the observer. Failure of the test in indicated by visible turbidity or other visual manifestations of growth in the medium in one or more container-closer units on or before the end of the incubation period. If any container-closer units demonstrate growth, the preliminary results will be reported to the CO/COR, to the Chief, Pharmacy Service, and to the Compounded Sterile Products Program Manager, Pharmacy Service as soon as the initial result is known as soon as the initial result is known, and results will be expeditiously reported after further antimicrobial testing is complete.

A failure in the media fill, gloved fingertip and thumb sampling, or surface sample constitutes an overall failure of the aseptic manipulation competency.

2. Compounding area certification: The vendor shall provide certification of classified areas using procedures in the current Controlled Environment Testing Association (CETA) application guides. Certification must be performed at least every 6 months and as needed depending on facility requirements or requests. Certification must include the following:

2. Airflow testing: The air changes per hour (ACPH) from the HVAC, ACPH contributed from the PEC, and the total ACPH must be documented on the certification report.

2. HEPA filter integrity testing: HEPA filters must be leak tested at the factory and then leak tested again after installation and as part of recertification.

2. Total particle count testing: Must be performed under dynamic operating conditions using current, state-of-the-art electronic equipment. Air sampling sites must be selected in all classified areas. Measurements must be taken in each PEC at locations where there is greatest risk to the exposed CSPs, containers, and closures. Measurements of nonviable airborne particles in other classified areas including the buffer room(s) and ante-room(s), should be taken at representative locations that reflect the quality of air in the room(s).

2. Smoke visualization studies: Must be performed initially and every 6 months for each PEC during dynamic operating conditions to demonstrate unidirectional airflow and sweeping action over and away from the preparation (s). Additional smoke tests will need to be performed in rooms without low air returns. A video of the smoke test must accompany the report. Any media files must be provided in DVD format to comply with VHA guidance for media. No .zip files, usb storage, flash drives, or downloadable files from vendor web sites.

2. Primary engineering control (PEC) certification (laminar flow hoods, biological safety cabinets, compounding aseptic isolators, compounding aseptic containment isolators, pass through chambers etc.). The PEC must be certified to meet ISO class 5 at 0.5 μm and larger particles during dynamic operating conditions. PEC certification must include all specifications as outlined per CETA application guides and pertinent USP chapters. This must be performed at least every 6 months and as needed depending on facility requirements.

2. Differential pressure certification: Must be performed at least every 6 months and as needed depending on facility requirements for ante rooms and buffer rooms. Cleanrooms used for non-hazardous compounding must be positive pressure relative to the adjacent spaces. USP chapter <797> requires a minimum pressure differential of 0.020” w.c. relative to adjacent spaces. Cleanrooms used for hazardous applications should be a minimum 0.010” w.c. negative relative to adjacent spaces.

2. Viable Air Sampling: Each classified area and pass through shall have volumetric active air sampling using an impaction device during dynamic operating conditions at least every 6 months and as needed depending on facility requirements. At least 1 cubic meter or 1000 liters of air should be sampled at each designated location. The media should be examined, and the report should detail the total number of discrete colonies of microorganisms on each plate as CFU per cubic meter of air based on the sample type, sample location and sample date. The genus of any microorganism recovered must be identified with the assistance of a microbiologist if the CFU count exceeds the following: greater than 1 for ISO Class 5, greater than 10 for ISO class 7, and greater than 100 for ISO class 8. If any container demonstrates the presence of CFU that exceed the actionable levels, the preliminary results will be reported to the Chief, Pharmacy Service, and corresponding Pharmacy Service point of contact as soon as the initial result is known, and final results will be expeditiously reported after further antimicrobial testing is complete.

2. Viable Surface Monitoring: Each classified area including the interior of the PEC (including equipment contained in it), staging or work areas near the PEC, frequently touched surfaces and pass-through chambers must be sampled at least monthly. Sampling should be performed at the end of the compounding activities, but before the area has been cleaned and disinfected. The media should be examined, and the report should detail the total number of discrete colonies of microorganisms on each device as CFU per sample based on the sample type, sample location and sample date. The genus of any microorganism recovered must be identified with the assistance of a microbiologist if the CFU count exceeds the following: greater than 3 for ISO Class 5, greater than 5 for ISO class 7, and greater than 50 for ISO class 8. If any device demonstrates the presence of CFU that exceed the actionable levels, the preliminary results will be reported to the Chief, Pharmacy Service and corresponding Pharmacy Service point of contact (COR, etc.) as soon as the initial result is known, and final results will be expeditiously reported after further antimicrobial testing is complete.

2. Environmental wipe sampling for hazardous drug (HD) surface residue should be performed routinely as outlined by USP <800> for those facilities listed in appendix A. Results will be reported to the Chief, Pharmacy Service, and corresponding Pharmacy Service point of contact (COR, etc.) as soon as results are available.

2. The contracting officer representative will schedule testing with the vendor. The vendor shall provide the corresponding Pharmacy Service with all service reports and certification of the job performed. After completion of work, the vendor shall notify the contracting officer representative for signature and verification of work performed.

2. All equipment shall be maintained in proper operating condition as specified by the Manufacturer, USP, CETA and FDA standards. The vendor is to have required supplies, manuals, and schematics, which must be available on site to perform the services. All work is to be performed in accordance with the guidelines established by state and local ordinances with manufacturer’s manual and quality control manual, and with all terms, conditions, provisions, schedules, and specifications provided herein.

2. In the event that the facility or personnel require recertification or testing due to actionable results, the vendor must be able to provide retesting within 7 calendar days of the request. If vendor is not able to provide services within the required timeframe, the vendor shall propose a reasonable alternative response time.

2. In the event that the samples obtained during testing are damaged during transport or processing, the vendor shall annotate the damage in the report and provide retesting within 7 calendar days of the request at no additional cost to the facility. If the vendor is not able to provide services within the required timeframe, the vendor shall propose a reasonable alternative response time.

1. CALIBRATION/CERTIFICATION PROCEDURES

1. Certifiers Instrument Calibration: Certificates of Calibration substantiating NIST (National Institute of Standards & Technology) traceability annual compliance with requirements, and minimum sensitivities of instruments used in conducting testing in accordance with national Sanitation Standard No. 49 for Class I and Class II Biological Safety Cabinets (BSC); and ISO Standard 146447 for Laminar Flow Clean Work Stations. Compliance with USP 797, USP 800, CETA CAG-002-2006, CETA CAG-003-2006v May 2015 Performance Meet or exceed ISO 14644-1 for Class 5 air quality.

1. Field calibration of Photometer used for filter leak testing shall be made by inserting an aerosol challenge upstream of the filter and sampling between the blower and filter to verify an upstream challenge concentration of at least 10 micrograms of DOP or similar challenge medium of air volume handled by the filter.

Contractor shall furnish equipment, parts, material, labor and supplies necessary to repair equipment listed in the Statement of Work. Contractor shall return equipment to full operational condition in accordance with manufacturer specifications. Contractor shall provide a written estimate with a breakout cost of labor, travel, material and parts prior to performance of repairs not to exceed $2,400.00. The written estimate shall be provided to the COR for CO final approval and funding. In the event that an emergency repair is needed, Contractor shall be onsite within 24 to 48 hours of request to evaluate and provide estimate. Weekend service may be required if no viable alternative is available.

Certification of classified areas (rooms and devices) using procedures in the current Controlled Environment Testing Association (CETA), USP Chapter 797, and VHA Directive 1108.12 Management & Monitoring of Pharmaceutical Compounded Sterile Preparations, USP Chapter 797, CETA CAG_003_2006 v2015: Sterile Compounding Facilities, CETA CAG_002_2006 v2008: Compounding_Isolator Testing_Guide Airflow testing is performed to determine acceptability of the air velocity and volume, the air exchange rate, and the room pressure differential in doorways between adjacent rooms to ensure consistent airflow and that the appropriate quality of air is maintained under dynamic operating conditions. The ACPH from HVAC, ACPH contributed from the PEC, and the total ACPH must be documented on the certification report.

• HEPA filter integrity testing: HEPA filters must be leak tested at the factory and then leak tested again after installation and as part of recertification.

• Total particle count testing (see 5.1 Total Airborne Particle Sampling): Total particle count testing must be performed under dynamic operating conditions using calibrated electronic equipment.

• Dynamic airflow smoke pattern test: Smoke pattern tests must be performed for each PEC during dynamic operating conditions to demonstrate unidirectional airflow and sweeping action over and away from the preparation(s). Smoke visualization studies: must have actual video for records , with written report.

Viable testing – Microbiological Air per CETA CAG_009_2011 V 2012 (USP 797 Viable Environmental Sampling Gowning Evaluation), USP Chapter 797—every 6 months, for all rooms. Each classified area and pass through shall have volumetric active air sampling using an impaction device during dynamic operating conditions Surface sampling per CETA CAG_009_2011 V 2012 (USP 797 Viable Environmental Sampling Gowning Evaluation) - Monthly, USP Chapter 797 Staff-- CETA CAG_009_2011 V 2012 (USP 797 Viable Environmental Sampling Gowning Evaluation), USP Chapter 797 every 6 months ( ~ 50 staff members): Gowning and Garbing Evaluation, Gloved fingertip and thumb sampling and Media-Fill Testing

F. EQUIPMENT LISTING AND LOCATION

Pharmacy Hoods - Bay Pines

6S-15-BH-18348

Cleanroom 2

LAFW

BZ-6SSRX

6 MOS

6S-15-BH-18350

Cleanroom 2

LAFW

6 MOS

6S-15-BH-18349

Cleanroom 1

LAFW

6 MOS

4S-15-VF-18347

SCA (Segregated Compounding Area)

CAI

VF-4USP

6 MOS

1360100 221510

SCA (Segregated Compounding Area)

CAI

NU-PR797-400

6 MOS

HAZARDOUS DRUG

3S-15-LGU-19184

Hazardous Buffer Room

3S-15-LGU-18158

Hazardous Buffer Room

4S-15-VF-19182

Non-Hazardous Buffer Room

Mobile CSP Pharmacy

3S-15-LGU-19249

LFGI-RUSP

6 MOS

3S-15-LGU-19250

LFGI-RUSP

6 MOS

3S-15-BH-19739

BZ-3SSRX

6 MOS

4S-15-BH-19738

BZ-4SSRX

6 MOS

Pharmacy Rooms - Bay Pines

5A CSP Pharmacy Satellite

Germfree Compounding Trailer

Pharmacy Hoods – Lee County

6S-15-BH-18100

Germfree BZ-6SS 6 mos.

170440933-E

Labconco B3 Ducted 6 mos.

Pharmacy Room – Lee County

6 mos.

Page 1 of Testing Breakdown

Every 6 Months

Air flow testing

HEPA filter integrity testing

Total particle count

Smoke visualization studies

Every 6 Months

Primary engineering controls Secondary engineering controls

Differential pressure certification

Viable Air Sampling HD environmental wipe sampling

Every Month

Surface Sampling

Page 1 of

Laboratory – Bay Pines

462.059

462.070

462.073

Other Hoods / Bay Pines

Other Hoods / Lee County

Research & Dental – Bay Pines & Lee County

3840000 Annual

462.070

462.085

100400000 Annual

130170339E

• Interior of the C-PEC and equipment contained in it

• Pass-through chambers

• Surfaces in staging or work areas near the C-PEC

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

• Areas immediately outside the HD buffer room or the C-SCA There are currently no studies demonstrating the effectiveness of a specific number or size of wipe samples in determining levels of HD contamination. Wipe sampling kits should be verified before use to ensure the method and reagent used have been tested to recover a specific percentage of known marker drugs from various surface types found in the sampled area.

There are currently no certifying agencies for vendors of wipe sample kits. There is currently no standard for acceptable limits for HD surface contamination. Common marker HDs that can be assayed include cyclophosphamide, ifosfamide, methotrexate, fluorouracil, and platinum-containing drugs. An example of measurable contamination would be cyclophosphamide levels >1.00 ng/cm2, which were shown in some studies to result in uptake of the drug in exposed workers. If any measurable contamination is found, the designated person must identify, document, and contain the cause of contamination. Such action may include reevaluating work practices, re-training personnel, performing thorough deactivation, decontamination, cleaning, and improving engineering controls. Repeat the wipe sampling to validate that the deactivation/decontamination and cleaning steps have been effective.

H. EVALUATED OPTIONAL FEATURES

Even though the Contractor, at the Government's option, provides the requirements specified in this section; they are nonetheless treated with the same level of control as the mandatory specifications. The CO shall only exercise these options when requested by the COR, and when the necessary funding is available.

1. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

The government will make the equipment available in accordance with the established schedule for the work.

L. CONTRACTOR EXPERIENCE REQUIREMENTS

Qualifications of Key Personnel (Standard mandatory language for all task orders):

1. Certification under the NSF Biohazard Cabinet Field Certifier Accreditation Program or the International Air Filtration Certifiers Association (IAFCA).

1. Respirator trained and fit-tested for protection against TB in accordance with 29 CFR 1910.134.

1. CETA Registered Certified Professional for Sterile Compounding Facilities

FAR Clauses:

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…