36C24420Q1110.docx

36C24420Q1110

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.

DUNS:

DUNS+4:

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. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C24420Q1110 09-22-2020 Kevin Balser 570-824-3521 X24071 10-08-2020 16:00 00244 Department of Veterans Affairs Network Contracting Office 4

Kevin Balser Kevin.balser@va.gov X 334516 1000 Employees N/A X 36C646 Pittsburgh VA Medical Center University Drive C Pittsburgh

PA

15240 00244

Austin Payment Center

PO Box 149971 Austin

TX

78714-9971

(877) 353-9791

(512) 460-5429 See CONTINUATION Page Special Staining, Immunohistochemistry (IHC)/In Situ Hybridization (ISH) Staining Systems for VA Medical Center in Pittsburgh, Pennsylvania per SOW Period of performance 11/1/2020-10/31/2020 See CONTINUATION Page X X Kevin Balser Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C244 Kevin M. Balser

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

3. INVOICES: Invoices shall be submitted in arrears:

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

Austin Payment Center Department of Veterans Affairs

PO Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

3. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:

(1) Vendor must accept the system without the drive;

(2) VA's initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

(3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

(4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

(a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

(b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.

(c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

4. SECURITY INCIDENT INVESTIGATION

a. The term "security incident" means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/ subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/ subcontractor has access.

5. LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. 5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

b. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

(3) Data breach analysis;

(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

6. TRAINING

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document - e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

b. The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

36C24420Q1110 (End of Clause) Page 1 of Page 1 of

B.3 STATEMENT OF WORK-HISTOLOGY STAINING SYSTEMS

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1. GENERAL: The Contractor shall provide Special Staining, Immunohistochemistry (IHC)/In Situ Hybridization (ISH) Staining Systems for VA Medical Center in Pittsburgh, Pennsylvania as outlined below. All work shall be performed in accordance with the guidelines established by Federal, State and local ordinances with the Food and Drug Administration (FDA) and manufacturer’s guidelines, and with all terms, conditions, provisions, schedules and specifications provided herein.

2. SCOPE: The U.S. Department of Veterans Affairs, Pittsburgh VA Medical Center anticipates a Reagent Usage Agreement from this Request for Quote using FAR Part 12 Commercial Item procedures. Pittsburgh VAMC will issue a reagent usage (Reagent Rental) for instrument use, supplies, installation, training, and servicing of the equipment (for the life of agreement) as identified below.

3. PERIOD OF PERFORMANCE: The Reagent Usage Agreement will consist of a 5 Year fixed price Indefinite quantity contract. The performance period will commence upon the Contracting Officer’s signature and will expire within five years unless canceled, terminated, or extended.

4. Cost per Test (CPT), Cost-Per-Test Clinical Laboratory Analyzers – Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering equipment use for the life of the contract. The laboratory instrument system(s) reagents are to include detection kits for IHC and for probes/in-situ hybridization (ISH) and reagents for Simple and Complex Special Stains, calibrators, quality controls, supplies, consumable/disposable items, paper, parts, accessories (including replacement of printers as they fail) and any other item required for the proper operation of the Contractor’s equipment including water supply systems and maintenance of these systems and anything necessary for the generation and reporting of a test result, all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and training for Government personnel both off-site and on-site. Contractors are required to provide delivery, installation and removal of equipment at no additional charge. The contractor shall furnish Pittsburgh VAMC the technical support necessary to operate the contractor’s equipment, hardware and software upgrades. Pittsburgh VAMC will pay for the test assays performed on the contractor’s equipment.

5. EQUIPMENT: The purpose of this section is to identify the salient characteristics of the IHC/ISH Staining System and Special Stain System, and specify functionality and performance-based requirements of this system. Each proposal shall include descriptive literature that meets the following specifications (as a minimum):

Requirements of Services to be provided:

1. Minimum Requirements:

0. Instrumentation / Analyzer:

0. IHC-ISH analyzers capable of the following:

0. Perform immunohistochemistry(IHC) and in situ hybridization (ISH) stains with the full range of techniques (immunohistochemical, immune special ISH, SISH, immunofluorescence, counterstain, titration) simultaneously on one instrument,

0. Perform pre-processing (deparfination, bake) on the analyzers,

0. Be fully automated (robotic) after adding samples to unit,

0. Have STAT capability while other testing is in progress,

0. Have ability to add slides while instrument is running other tests,

0. Have ability to add or change reagents while instrument is running other tests,

0. Have bar code tracking of samples and reagents,

0. Have IHC turnaround time of 2.5 hours or less,

0. Be a freestanding floor model to fit in existing VAPAHCS laboratory space of approximate dimensions 45”W x 32”D x 62”H.

0. Special Stains analyzers capable of the following:

1. Perform special histology stains: AFB, alcian yellow, congo red, diastase, steiner, GMS, iron, PAS, reticulum, Stiner II, trichrome,

1. Have a special stains turnaround time of 20 slides in 20 minutes or less,

1. Have a high degree of automated features for tracking patient slides, reagents, waste, maintenance,

1. Single slide heating (independent control) and liquid cover slip technology,

1. Have bar code tracking of slides,

1. Be a free standing floor model.

0. Data & System Management/Interface to support all provided instrumentation, capable of the following:

2. Allow user to view status of patient tests during instrument operation,

2. Have lab instrument and Contractor remote link support for troubleshooting and software upgrades,

2. Have connectivity of IHC-ISH and Special Stain analyzers to data management system.

6. GENERAL REQUIREMENTS: The contractor is required to provide new state-of-the-art staining equipment; discontinued models are unacceptable. The contractor shall provide all operational upgrades to the equipment hardware and operating system software that materially affect the performance of the equipment at no additional charge to the government. These enhancements to the contractor’s equipment shall be delivered to the government site and installed by the contractor within 60 days of their issuance or date of first commercial availability. Note: The C& A Requirements do not apply. A Security Accreditation Package is not necessary.

All models shall perform satisfactorily at any laboratory temperature between 59 and 86 degrees Fahrenheit (15 and 30 degrees Celsius). All models shall perform satisfactorily at any laboratory relative humidity between 10 and 70%. The contractor shall provide an electronic operator’s manual with each supplied model. Trade-in of existing equipment will be negotiated by the Contracting Office and is not included in the scope of this contract.

a. Site Preparation: Specifications shall be furnished in writing by the contractor as part of the equipment proposal. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to the manufacturer’s claimed specifications. The government shall prepare the site at its own expense and in accordance with the specifications furnished by the contractor. Any alterations or modifications in site preparation, which are attributable to incomplete or erroneous specifications provided by the contractor which would involve additional expense to the government, shall be made at the expense of the contractor.

b. Ownership of Equipment: The contractor shall maintain ownership of all equipment resulting from award of this solicitation. All accessories (hardware and software) furnished by the contractor shall accompany the equipment when returned to the contractor. The contractor, upon expiration of order(s) at termination and/or replacement of equipment, will remove the equipment. The contractor will disconnect the equipment (gas, water, air, etc.) and will be responsible for all packing and shipping required to remove the equipment within ten (10) business days.

c. Standard and acceptance of performance shall begin on the installation date. It shall end on the earlier date of when a certificate of acceptance is signed or the equipment meets the standard of performance for a period of 30 consecutive calendar days by operating in conformation with the contractor’s technical specification or as quoted in any contract at an effectiveness level of 90% or more. In the event the equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance test shall continue on a daily basis until the standard of performance is met for a total of 30 consecutive days. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the VA may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4(m) “Contract terms and conditions – Commercial Items, Termination for cause.

Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the government makes a bona fine attempt to contact the contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the government in proper operating condition.

During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work will be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours. The VA shall maintain appropriate daily records to satisfy the requirements of this paragraph and shall notify the contractor in writing of the date of the first day of the successful performance period. Operational use time and downtime shall be measured in hours and whole minutes.

7. Government Responsibility: The VA site will perform routine maintenance per manufacturer operation and maintenance manuals.

8. Training of Operating Personnel:

The contractor shall provide a qualified technician at the time of equipment installation and at such time designated by Contracting Officer (CO) or Contracting Officer's Technical Representative (COTR) to provide on-site orientation and training to designated personnel in: (1) operation and care of equipment; (2) techniques and procedures recommended by manufacturer to achieve maximum dependable, efficient, and economical utilization of equipment. This training shall include actual demonstration and operation of the equipment including any adjustments or other actions which may be undertaken by operating personnel in the event of failure of equipment, provided that such adjustment or action will in no way jeopardize the contractor’s warranty. This training shall include at least two (2), two-day on-site training sessions, all day, upon installation and acceptance of equipment and later, for refresher training.

9. Installation procedures: The contractor shall be responsible for installation, which consists of in-house delivery, positioning, and mounting of all equipment listed on the delivery order and connections of all equipment and interconnecting wiring and cabling, if applicable. Upon award, the contractor must notify the COTR of any problems which may be anticipated in connection with installation or which will affect optimum performance once installation is completed. In the event that progress of the installation is interrupted through no fault of the contractor, the continuous installation referenced in the preceding paragraphs may be suspended until the cause of delay is rectified. The contractor shall continue performance within 24 hours after notification is received from the government.

Final acceptance of the equipment and installation is based upon an inspection and test performed within ten (10) calendar days from the installation date.

10. Quality of Reagents, Supplies and Disposables:

The contractor will assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality slide product. The reagent quality (as a minimum) must satisfy proficiency-testing standards of the College of American Pathologists (CAP) and The Joint Commission. In the event that the supplies to include detection kits, stains, and/or consumables are defective and unsuitable or the contractor failed to comply with the requirements herein, the contractor shall deliver ample supplies (under normal government test load volume) within 24 hours after notification at no additional cost to the VA.

11. DELIVERY LOCATIONS: The Pittsburgh VAMC projects the following estimated number of slides processed on the individual equipment:

* Instruments and Estimated Slide Quantities per Year

2 SS

10,000 2,900

* The totals are only an estimate and should not be considered a guarantee for future orders

12. MAINTENANCE: The contractor shall provide maintenance (labor and parts) to maintain the equipment in satisfactory operating condition and subject to security regulations. The VA shall provide access to the equipment in order to perform maintenance services.

The contractor shall perform emergency repairs within 48 hours after notification from the COTR. The contractor will provide all parts and labor needed to repair the malfunction. Travel, per diem and other associated repair expenses are borne by the contractor.

The contractor shall furnish a malfunction incident report to the installation upon completion of each maintenance call. The report shall include, as a minimum, the following: (a) date and time of notification, (b) date and time of arrival, (c) serial number type and model number(s) of equipment, (d) time spent for repair, (e) description of malfunction and (f) proof of repair.

13. TRAINING AND TECHNICAL SERVICE: The contractor shall provide training at a government location for two operating personnel at the time of installation of the contractor’s equipment at no additional charge to the VA. Additionally, the contractor, at his/her discretion, may make training available at his/her facility on terms and conditions mutually agreed upon by the VA and the contractor. In addition, the contractor shall provide supplemental operating training to the government personnel, without additional charge to the government, upon installation of the upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished.

14. PERFORMANCE, DELIVERY, INSPECTION AND ACCEPTANCE: The VA shall require the contractor to deliver the equipment ordered under this contract not later than Sixty (60) calendar days after award. The VA reserves the right to thoroughly inspect and investigate the contractor and manufacturer business reputations and other qualifications, and to reject any bid, irrespective of price, that shall be administratively determined lacking in any of the essentials necessary to assure acceptable standards of performance. Acceptance will normally be consummated upon delivery and, when applicable, installation and completion of personnel training. The VA reserves the right to request a ninety (90) day test and evaluation of equipment prior to placing an order. If the test and evaluation is unsuccessful as determined by the CO and COTR for this VA, the VA will not be required to continue with placing orders under this agreement, and no default or penalty will accrue.

15. SERVICE: The Contractor shall provide maintenance services within 48 hours notice from the Contracting Officer or designee. Emergency service must be provided within 8 working hours of notification; telephone responses will not satisfy this requirement. During the warranty period, service will be provided during regular working hours (Monday – Friday, 8:00 am – 4:30 p.m., excluding weekends and holidays).

16. AVAILABILITY OF SERVICE: The contractor guarantees availability of servicing and replacement parts during performance period.

17. CONTRACTOR TESTING AND INSPECTION: The contractor is responsible for performing all inspections and tests necessary to substantiate that the equipment, supplies and services conform to contract requirements. Government testing and inspection will not unduly delay contractor performance, nor will it create a defect in services covered by the award.

18. REGULATORY REQUIREMENTS: If the product(s) included in this SOW are considered medical devices by the US Food and Drug Administration, the manufacturer shall be in compliance with the Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder.

19. TECHNICAL INDUSTRY STANDARDS: The contractor certifies that all equipment conforms to all common industry standards.

20. MANUFACTURED PRODUCTS: Materials shall conform to current productions of manufacturers regularly engaged in manufacture of such items. Contracting Officer will approve deviations from products and manufacturers as shown in the schedule of items. The shelf life of all consumables shall be at least ONE (1) YEAR from shipping date unless FDA specifies a different expiration date.

21. Reference Specifications and Publications: Where an item is required to conform to certain requirements, conformance shall be evidenced by seal, label, stamp, or approval listing from such agency, or by a certified test report from an independent testing laboratory acceptable to the Government, that the item has been tested and conforms to requirements of referenced agency.

22. RECALLS: If at any time during the term of the contract, the FDA or the Contractor, or subcontractor initiates an item recall or FDA withdraws its approval to manufacture an item, the contractor will issue a notice to indicate the complete item description and identification of the recall with necessary instructions for return for credit or replacement.

23. CONTRACT ADMINISTRATION: The Contracting Officer (CO) is the only person authorized to approve changes or modify the statement of work or any of the contract requirements. Only the CO is authorized to issue changes that affect price, quantity, or quality of performance of this contract. In the event the contractor effects any such change at the direction of any person other than the CO, the change shall be considered to have been made without authority and no adjustment will be made in contract price to cover any increase in costs incurred as a result thereof.

24. AREA OF RESPONSIBILITY and Place of Performance: The VISN 4 Medical Center COR is listed below.

Pittsburgh VA Medical Center University Drive C Pittsburgh, Pa. 15240 Loc: 2NE106

B.4 PRICE/COST SCHEDULE

The following price schedule is for a firm fixed price indefinite quantity contract on a cost per test basis as stated in the SOW. The quantity of tests below are estimated volumes based on past needs and are not a guarantee of future needs.

ITEM INFORMATION

immuno stainer including service when needed Contract Period: Base POP Begin: 11-01-2020 POP End: 10-31-2025

LOCAL STOCK NUMBER: 00000

Stainer Cleaning Kit

POP Begin: 11-01-2020

Immunohistochemistry (IHC)/In Situ Hybridization (ISH) Staining Systems on a Cost per Test (CPT) Basis - Cost-Per-Test Clinical Laboratory Analyzers

Special Staining (SS) as Cost per Test (CPT) - Cost-Per-Test Clinical Laboratory Analyzers

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SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

(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 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 32.608-2 of the Federal Acquisition Regulation 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. 2409 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 ITEMS 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 52.216-18 ORDERING (OCT 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from 11/1/2020 through 10/31/2025.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) If mailed, a delivery order or task order is considered "issued" when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule.

(End of Clause)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than 10000, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of 500000;

(2) Any order for a combination of items in excess of 2500000; or

(3) A series of orders from the same ordering office within 5 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 3 days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of Clause)

C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum."

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period; provided, that the Contractor shall not be required to make any…