RFQ - 36C24221Q0289 - IHC Autostainer - Buffalo VA.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. 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 70

36C24221Q0289 12-15-2020

DEMUZIO, SAM 585-393-7735 01-08-2021

4:00 PM

Department of Veterans Affairs 400 Fort Hill Ave.

Canandaigua NY 14424

X

334516

1000 Employees

N/A

X

Buffalo VA Medical Center

3495 Bailey Avenue Buffalo NY 14215

Network Contracting Activity 400 Fort Hill Ave.

Canandaigua NY 14424

Tungsten Network http://www.tungsten-network.com/us/en /veterans-affairs

See CONTINUATION Page

Clinical Laboratory Immunohistochemistry Stainer.

Fluorescence In-situ hybridization (FISH) and In-situ hybridization (ISH) Testing.

Place of performance: Buffalo VA Medical Center, Buffalo, New York.

$0.00 See CONTINUATION Page

X X

SAM DEMUZIO

CONTRACTING OFFICER

36C24221Q0289

Table of Contents

SECTION A

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

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK………………………………………………………………….4

SECTION C - CONTRACT CLAUSES

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

2018)

C.2 52.216-18 ORDERING (AUG 2020)

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

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

C.5 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

C.6 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.7 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 32

C.8 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.9 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.10 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

C.11 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

C.12 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.13 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.14 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (OCT 2020)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JUN 2020) 45

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

E.3 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.4 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (OCT 2020)

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 36C242 Sam DeMuzio

Department of Veterans Affairs

400 Fort Hill Ave.

Canandaigua NY 14424

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

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other []

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.

Tungsten Network http://www.tungsten-network.com/us/en

/veterans-affairs

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

AMENDMENT NO DATE

B.2 DESCRIPTION – SPECIFICATIONS - STATEMENT OF WORK

Immunohistochemistry (IHC) is a key diagnostic tool in tissue pathology. Once the slides have been prepared using the IHC system they are sent to a pathologist for diagnosis.

IHC stains are used to visualize antigens and proteins in a tissue with the help of enzymatically or fluorescently labeled antibodies. The Clinical Laboratory Immunohistochemistry Stainer needs to be an automated system for drying, dewaxing, cell conditioning, application of antibodies, detection, and counterstain chemistry. The instrument platform must include In-situ hybridization (ISH) testing and Fluorescence in situ hybridization. (FISH)

The instrument must utilize a flexible open system which can employ any available primary antibody or detection system which is commercially available. An “open system” has the ability to accept third party reagents. The open system must be compatible to creating custom staining protocols and run multiple detection systems and chromogens in a single run while retaining optimal staining results.

Clinical Laboratory Immunohistochemistry (IHC and ISH and FISH) instrument - - Automated system for drying, dewaxing, cell conditioning, application of antibodies, detection, and counterstain chemistry.

1. SCOPE OF PROCUREMENT:

• The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the Statement of Work. Refer to Attachment A for required test menu /stains and estimated annual volumes.

• The equipment must maintain or preferably reduce the overall labor (technologist time) required to accomplish the required testing.

• The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards and control containers.

Unexpected changes in methodology/technology shall be at the expense of the

Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award.

• Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the Contractor’s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

2.DEFINITIONS

• Cost per test (CPT) - The Contractor is required to provide a price for each test that can be performed on their equipment. The per test price shall include costs covering the following: (1) Five-year equipment use. (2) All reagents, standards, quality controls, supplies, consumables and disposable items, parts, accessories, and any other items required for the proper operation of the Contractor’s equipment and necessary for the generation and reporting of a test result. 3) Printer and print cartridges /toner as needed. All products to be shipped FOB Destination without any exceptions. (3) All necessary maintenance to keep the equipment fully operational to include emergency repairs. Daily, weekly, and monthly Preventive Maintenance is the responsibility of the Laboratory Technicians. (4) Training for Government personnel. (5) The Contractor is required to provide delivery, installation, and removal of their equipment upon contract completion at no additional charge. (6) Fully automated or semi-automated system that requires minimal hands on technician time to complete testing of all parameters as defined in the statement of work. (7) Contractors shall provide delivery, installation and removal of equipment at no additional charge.

• Business Associate Agreement (BAA)- A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule.

3.TEST MENU

REQUIREMENT: Immunohistochemical (IHC) Stainer – Cost Per Test (Cpt) Includes Equipment, Consumables, Service & Maintenance In Accordance With Mfg.

Recommendations, Training.

Contractor shall provide new equipment, reagents, consumables, preventative maintenance, repairs and training. Equipment shall be installed, configured and validated by the contractor. In the event the workload increases, contractor shall be able to fulfill the Government needs.

• Fully automated FDA approved PD-L1 IHC 22C3 must be included in test menu

• FISH probes must include ALK/Ros/Ret

• The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the Statement of Work. Refer to Attachment A for required test menu /stains and estimated annual volumes.

• The VAWNY Healthcare system at Buffalo estimates a test volume of 500 slides per month. Instrument must provide capability for both batch and stat patient-case processing.

• Our lab performs FISH testing for HER-2 and ALK gene rearrangements on in-house specimens and on specimens from referring hospitals within our VISN.

We anticipate future increase in HER-2 and ALK FISH testing.

4. GENERAL REQUIREMENTS

• Primary IHC instrument and secondary benchtop backup instrument to provide testing of all parameters outlined in Attachment A. Primary Analyzer - Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein.

• Ability to run simultaneous FISH and IHC runs with minimal impact to IHC

• Instrument must provide both Batch and/or urgent patient-case processing, and ability to add/remove reagents without interrupting cases in process or impacting workflow including capability to prioritize stains in process.

• Capacity for a minimum of 48 slides and minimum of 50 reagents on board, Accurate metering capability for monitoring reagent usages and reagent level detection. Reagent tracking must include product code, Lot number and expiration date.

• The instrument must utilize a flexible open system, which includes use of reagents from third party vendors, able to create custom staining protocols and run multiple detection systems and chromogens in a single run, while retaining optimal staining results.

• Unless otherwise stated, all equipment shall be held to current industry standards for such equipment as present within the current market for Immunohistochemistry (IHC) equipment, supplies and services.

• A printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient’s name and accession or unique identifier number (UID). Backup printer provided in the event of printer equipment failure.

• An uninterruptible power supply (UPS) with line conditioner for each instrument provided.

• Ancillary support equipment – The Contractor shall provide, install and maintain through the life of the BPA, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc.

• Commercial Offerings – The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g. Electronic copy of the procedure manual in CLSI format or an on-line procedure manual in the instrument software.

• Provided instrument shall be able to accommodate a 20% increase in workload during the period of this agreement.

• The IHC system must consistently deliver only the amount of reagent required with no cross-contamination between slides. Fresh reagents must be applied to each slide.

• Easy slide insertion with minimal handling of slides.

5. TECHNICAL REQUIREMENTS

• All equipment shall be new, state of the art, and not used, recertified nor refurbished.

• The instrument must utilize a flexible open system, which includes use of reagents from third party vendors, Use of third party reagent must include acceptable value of cost per test to the government.

• Capacity for a minimum of 48 slides and minimum of 50 reagents on board.

Accurate metering capability for monitoring reagent usages and reagent level detection. Reagent tracking must include product code, Lot number and expiration date.

• Positive identification of slides and reagents to minimize errors.

• Must have the ability and flexibility to add and remove reagents without interrupting cases in process or impacting workflow including capability to prioritize the stains in process. Ease of use with reagent handling, i.e., barcoded reagents to prevent or reduce reagent mix up, ability to load reagents on as needed basis in an expeditious manner. Onboard reagent stability will be evaluated. Pre-packaged bulk solution reagent kits with no mixing and continuous access to bulks and waste for improved workflow. Techs must be able to access waste with minimal delay for slide processing.

• Able to create custom staining protocols and run multiple detection systems and chromogens in a single run, while retaining optimal staining results.

• Daily Maintenance not to exceed 15 minutes per day

• Sufficient safety features to avoid exposure to bio-hazardous and chemical material.

• All Service and Maintenance costs must be included in cost per test, no additional charges will be invoiced for service or maintenance

• VA Healthcare WNY at Buffalo will provide anticipated annual usage with understanding that it is only an estimate.

• The system must perform IHC, ISH and FISH, and have capability for fully automated overnight runs and fully automated FISH testing. Technician intervention not required once slides and reagents have been loaded onto instrument, once daily maintenance has been completed.

• The system must be fully automated and provide slide pretreatment, baking, deparaffinization, and cell conditioning

• Optimal quality of slide staining as determined by VA WNY Healthcare system at Buffalo Staff pathologists.

• Sufficient safety features to avoid unnecessary exposure to bio-hazardous and chemical material. The exposure to and the volume of bio-hazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling.

• VA Safety regulations require strict control of chemical waste disposal. The system must separate hazardous waste from non-hazardous waste for GEMS and EPA compliance: 40 Code of Federal Regulations (CFR) Title 40: Protection of the Environment Part 261- Identification of Hazardous Waste.

• Minimal maintenance required, Vendor must specify time required for daily, weekly and monthly maintenance. There shall be easy access to the instrument for the technical operator to perform maintenance.

• Ability to connect to Data Innovations LIS interface bi-directionally

• Computer connectors/servers need to be pinned correctly in order to transfer data from the instruments to the data server and shall be provided by the contractor.

• Instrumentation, reagents, consumables and all other provided equipment shall have a total footprint that, when installed/stored in the laboratory shall save space and shall not negatively impact the functionality/operations of that laboratory. This footprint shall not require significant and/or costly infrastructure changes. The physical system must have a footprint in order to meet the confined space of the existing laboratory space.

• Ability to store and retransmit records in case of interface outage.

• Have independently functioning slide staining chambers, or equivalent solution, to preserve sample integrity.

• Have the ability to add short turnaround time (STAT) slides with no interruption to routine runs.

• Ability to load slides with delayed start time, and fully automated overnight runs

• The software must be user-friendly, easy to navigate, and provide reliable programs to manage testing, slides, reagents, workflow and chemical waste.

• Equipment shall have accurate metering capability for monitoring reagent usage and reagent level detection. Reagent tracking must include product code, LOT number and expiration date. The Contractor may in the alternative provide another means of tracking reagent usage and reagent level detection if the metering capability is not practical. System will have an effective automatic detection and tracking of insufficient reagent quantities and alert for tests remaining. The instrument shall include buttons and barcodes that automatically register and locate staining kits and slides. Barcoded reagents in which the Instruments must have capability to ensure that one can't use reagents if they are expired or if the volume of the reagents is insufficient to complete the run.

Information must be provided regarding waste capacity and how often bulk waste and hazardous waste must be emptied. Waste volume report must be provided by vendor.

• Provide instrument Operation Manual" printed copy at each facility and electronic procedure manual in the instrument software. The procedure manual shall be formatted in accordance with current approved CLSI guidelines.

6. SERVICE AND MAINTENANCE REQUIREMENTS

• Telephone technical assistance shall be available 24 hours/day 365 days/year.

• Service engineer shall arrive on-site within 24 hours of determination of need for field service rep.

• Service engineer available within a reasonable distance. Service coverage at a minimum of Monday thru Friday 8am-5pm.

• Preventative maintenance shall be performed by contractor in accordance with the manufacturer’s suggested schedule. A copy of the PM schedule must accompany quote.

• Agreement shall include replacement of all parts found not to be functioning properly by contractor or customer

• If an instrument cannot be repaired within 4 days, a replacement instrument will be provided.

• A minimum of two (2) scheduled preventative maintenance calls per year at each facility, once every six (6) months unless otherwise stated within a deviation document. A deviation shall be granted if this deviation is in the best interest of VISN under CO discretion.

• The Contractor shall visit each facility at minimum one (1) time per quarter to review the account, provide product information, answer questions, provide Customer Service, handle any defective merchandise, and take care of any other issues that have not been resolved. The schedule shall be created post-award directly with the point of contacts provided at the time of award.

• A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following:

1. Date and time notified

2. Date and time of arrival

3. Serial number, type and model number of equipment

4. Time spent for repair, and Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

5. Each notification for an emergency repair service call shall be treated as a separate and new service call.

6. A copy of each service/maintenance record shall be provided to the corresponding VA facility COR within five (5) working days of service/maintenance completion.

7. The Contractor will immediately notify the CO and Contracting Officer’s Representative (COR) of any recalls of product or other important product safety issues. As appropriate, the Contractor will replace and/or reimburse recalled/defective products at no cost to the Government. The Contractor may be liable for costs processing recalls, i.e. administrative and clinical services to replace recalled/defective products.

7. SUPPORT FEATURES

• Installation/Site Preparation: Site preparation specifications shall be furnished in writing by the Contractor as a Site Preparation Report after award. The report shall be provided to the CO at least ninety (90) days before installation. The Contractor shall visit each site and propose the location of equipment and determine specific site prep requirements including but not limited to:

o Space availability o Power availability o Availability of waste drainage systems o Increase heat load affecting air conditioning o Specialized ventilation if required o Special finishes required o Carts for non-floor standing instrumentation

• Start-Up Reagents: The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item included on the list of supplies defined in the Federal Supply Schedule contract and required to establish instruments for operation for performance of acceptance testing. Government.

• Upgrades – The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of-the-art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e. new versions of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under this BPA; however, it does refer to significant changes in the hardware operational capability.

• Online ordering capabilities for supplies, consumables, or reagents as well as online submission of test counts are preferred.

• The Contractor shall provide technical support for the performance of The instrument to the satisfaction of the Government, all validation studies including:

stain quality precision, method comparison with current instrument , accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no additional cost to the Government. This shall be done by the Contractor for a minimum 2-week period under the supervision of the VA laboratory designee to the satisfaction of the medical director.

• Validation must be performed to the satisfaction of the Lab medical director.

8.TRAINING

• The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services and minimally equivalent to the terms and conditions for training. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide on-site training by support specialists for minimally one (1) operator per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant included in the Blended CPRR/CPT price. In addition, remote training shall be included.

9. REPORTS

• The Contractor shall provide to the Contracting Officer and other individuals (designated post-award) a copy of a quarterly report of sales, by ordering facility, within 30 calendar days after the close of each quarter’s business. Reports are to reflect, at a minimum, total net sales amounts before discount, and discount amounts by ordering facility as well as the raw data used to develop these reports. These reports shall be used to monitor the commitment of each facility, reporting the savings realized and shall be shared with each participating facility, personnel associated with acquiring the products, and respective laboratory personnel. Additional invoice charges associated with reagent and/or supply wastage or repair parts included at no charge (per FSS awarded contract) shall not be accepted. There will be no additional charges for any reports required as part of the BPA.

10.STANDARD AND QUALITY OF PERFORMANCE

• This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order [or BPA] is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor’s technical specification or as quoted in any BPA at an effectiveness level of 90% or more.

• In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day 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 user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled “Termination for cause.” (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.)

• 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 fide 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 shall 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 Government will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes.

• During the term of the contract, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment.

11 CHARACTERIZATION OF WASTE

• The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated.

• The determination and description shall address the following:

o Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24) o Waste ignitability (Reference 40 CFR §261.21) o Waste corrosivity (Reference 40 CFR §261.22) o Waste reactivity (Reference 40 CFR §261.23) o Hazardous waste from non-specific sources (F-listed) (Reference

40 CFR §261.31)

o Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33) o Solid Waste (Reference 40 CFR §261.2) o Exclusions (Reference 40 CFR §261.4)

• The contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

• Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided.

All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e.

mercury, thimerosol and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with offeror response:

Barium (Total) Cadmium (Total) Chromium (Total) Copper (Total) Cyanide (Total) Lead (Total) Mercury (Total) Nickel (Total) Silver (Total) Zinc (Total) Arsenic (Total) Selenium (Total) Tin (Total) pH Flash point (to higher than 200F) BOD; biochemical oxygen demand

• The documentation the contractor provides will be used to work with the

VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system

12.GOVERNMENT’S RESPONSIBILITY

The user will perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph.

13. OWNERSHIP OF EQUIPMENT

Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) 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, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer.

The Contractor will identify if removable media is required to perform their duties. The Clinical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility.

Prior to termination or completion of this Contract, the Contractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this Contract without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination or completion of the Contract.

All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the Contract or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the Contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination or completion of the Contract or disposal or return of the IT equipment, whichever is earlier

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 Contractor at the end of lease, for trade-in, or other purposes. The options are:

1. Contractor must accept the system without the drive;

2. VA’s initial medical device procurement 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.

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;

4. The equipment Contractor must have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and

5. 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 BPA.

6. 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 Information Security Officer (ISO) needs to maintain the documentation.

14. National Holidays:

Federal Holidays consist of:

New Year's Day Martin Luther King's Birthday President's Day Memorial Day Independence Day Labor Day

Columbus Day Veterans Day Thanksgiving Day Christmas Day

15. Designation Of Contract Officer Representation

COR will be designated in writing. COR will be furnishing technical guidance and advice regarding the work being performed under this contract. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to the financial or legal aspects of the contract. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer.

The Contractor shall provide with their proposal an implementation plan for installation of their new equipment. The Contractor’s submitted plan shall not exceed ninety days for the transition of all requirements under the awarded Contract including installation and training of personnel, transition of all testing materials, reagents and supplies, and performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate the awarded Contract for cause under the Termination for Cause clause of the awarded Contract.

At the end of ninety days from the award of the Contract, the awarded Contractor shall have full and sole responsibility for all requirements identified in this Statement of Work against the awarded Contract.

Total period of performance shall not exceed five years. Each option year exercised shall be funded by a separate delivery/task order.

Dates are dependent upon award date:

PART I: Base Year: January 29, 2021 through September 30, 2021

PART II: 1st Option Year: October 1, 2021 through September 30, 2022

PART III: 2nd Option Year: October 1, 2022 through September 30, 2023

PART IV: 3rd Option Year: October 1, 2023 through September 30, 2024

PART V: 4th Option Year: October 1, 2024 through September 30, 2025

Price/Cost Schedule:

PART I: Base Year: January 29, 2021 through September 30, 2021

CLIN DESCRIPTION QTY UNIT PRICE/EACH TOTAL

IHC Autostainer – cost per slide format 5000 ea

PART II: 1st Option Year: October 1, 2021 through September 30, 2022

CLIN DESCRIPTION QTY UNIT PRICE/EACH TOTAL

IHC Autostainer – cost per slide format 5000 ea

PART III: 2nd Option Year: October 1, 2022 through September 30, 2023

3 IHC Autostainer – cost per slide format

5000 ea

PART IV: 3rd Option Year: October 1, 2023 through September 30, 2024

4 IHC Autostainer – cost per slide format

5000 ea

PART V: 4th Option Year: October 1, 2024 through September 30, 2025

IHC Autostainer – cost per slide format 5000 ea

ATTACHMENT A

TEST MENU

ANTIBODIES/REAGENTS REQUIRED TESTING DIAGNOSTICS

BCL-1 (Cyclin D1) 60 ALK FISH 95 Tests

BCL-2 48 ROS-1 FISH

BCL-6 40 RET FISH

BER EP4 36 ALK - IHC test

Calretinin 48 Hercep Test

CD 3 150 PDL-1 CLONE 22C3

CD 5 57 Her2 IQ FISH 23 tests

CD 10 55

CD 15 (Leu-M-1) 12

CD 20 150

CD 21 25

CD 23 36

CD 30 (Ki-1) 70

CD 31 70

CD 34 108

CD 43 30

CK 7 60

CK 20 60

Desmin 56

EMA 36

ER (Estrogen Receptor) 40

HepPar -1 (Hepatocyte) 12

Her2 Neu 95

HMW-CK 200

H. pylori 350

Ig A

Ig G 2

Ig M

KAPPA 21

KI-67 49

LAMBDA 16

Mart 1 (Melan A) 100

MLH-1 75

MPO 48

MSH-2 84

MSH-6 70

Napsin A 60

P16

P40

P53 14

P63 129

Pancytokeratin+ 130

PD-L1 240

PIN3

PIN4

PMS-2 60

PR 30

PSA 30

S-100 84

SOX10 230

Synaptophysin 48

UNC-Mouse 880 Controls

UNC-Rabbit 600 Controls

TTF-1 90

CDX2 40

Chromogranin A 30

CD45 24

CD56 70

CD79a 60

CD117 72

CD138 125

CD163 50

CEA 20

CK5/6 70

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…