REQUIREMENT.docx

36C24220Q0390

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

36C24220Q0390 6/30/2020

EDMONDS, DENISE

315-425-4400 7/17/2020 12:00 Department of Veterans Affairs 1304 Buckley Road Suite 104 Syracuse NY 13212 X 334516 1000 Employees N/A X Department of Veterans Affairs Albany VA Medical Center Buffalo VA Medical Center Syracuse VA Medical Center

NY

Department of Veterans Affairs Network Contracting Activity 1304 Buckley Rd Suite 104 Syracuse NY 13212

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

See CONTINUATION Page Cost Per Reportable Result - Blood Gas - for the Albany, Buffalo and Syracuse VA Medical Center Laboratories.

All proposals must be emailed to the Contracting Officer The attached 6550 form and the attached MDS Sheet must be completed and submitted with your proposal documents.

Page one of this solicitation must be signed by all offerors.

Your technical responses must specifically address each technical evaluation factor. Products literature may be submitted, however products literature shall not be used as a substitute for providing responses to technical evaluation factors.

$0.00 See CONTINUATION Page X X X Denise A Edmonds Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 INTRODUCTION

In the spirit of the Federal Acquisition Streamlining Act, the Department of Veterans Affairs (DVA) and hereby enter into a cooperative agreement, otherwise referred to as a Blanket Purchase Agreement (BPA). The agreement details all supplies with accompanying prices and descriptions, which may be ordered under this BPA.

This BPA expires on 9/30/3021 or such later ending date as determined by the exercise of any option.

All orders placed against this BPA are subject to the terms and conditions of all the clauses and provisions in full text or incorporated by reference in this document.

B.2 TERMS AND CONDITIONS

Blanket Purchase Agreements, the Contractor agrees to the following terms of a Blanket Purchase Agreement (BPA) EXCLUSIVELY WITH the Department of Veterans Affairs:

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C242 Department of Veterans Affairs 1304 Buckley Road Suite 104 Syracuse NY 13212

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.

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:

B.3 PRICING DATA

ITEM INFORMATION

Blood Gas Testing - Albany VAMC Base Year

POP: 10/1/2020 - 9/30/2021

Blood Gas Testing - Buffalo VAMC

Blood Gas Testing - Syracuse VAMC

Blood Gas Testing - Albany VAMC Option Year 1

POP: 10/1/2021 - 9/30/2022

Blood Gas Testing - Buffalo VAMC

Blood Gas Testing - Syracuse VAMC

Blood Gas Testing - Albany VAMC Option Year 2

POP: 10/1/2022 - 9/30/2023

Blood Gas Testing - Buffalo VAMC

Blood Gas Testing - Syracuse VAMC

Blood Gas Testing - Albany VAMC Option Year 3

POP: 10/1/2023 - 9/30/2024

Blood Gas Testing - Buffalo VAMC

Blood Gas Testing - Syracuse VAMC

Blood Gas Testing - Albany VAMC Option Year 4

POP: 10/1/2024 - 9/30/2025

Blood Gas Testing - Buffalo VAMC

Blood Gas Testing - Syracuse VAMC

B.4 OPTION TO EXTEND THE TERM OF THE BPA

a. The Government may extend the term of this BPA by written notice to the Contractor at any time prior to the expiration of the BPA, provided that the Government shall give the Contractor a preliminary written notice of its intent to extend at least 60 days before the BPA expires. The preliminary notice does not commit the Government to an extension.

b. If the Government exercises this option, the extended BPA shall be considered to include this option provision.

c. The total duration of this BPA, including the exercise of any options under this clause, shall not exceed the performance period.

B.5 OBLIGATION OF FUNDS

This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the BPA by the Contracting Officer.

B.6 PERIOD OF PERFORMANCE

This BPA expires on 9/30/2021 or such later ending date as determined by the exercise of any option.

B.7 AUTHORIZED INDIVIDUALS

Individuals Authorized to Place Orders: CORS and authorized Pharmacy Techs – to be named on award document

B.8 ORDER FORMAT

Orders will be placed against this BPA via e-mail, Electronic Data Interchange (EDI), FAX, or in hardcopy format. Each individual BPA Task Order will describe the tasks, services and deliverables required.

B.9 AUTHORIZED REPRESENTATIVES

The Primary Contracting Officer (CO) for this Agreement is:

The Primary Contracting Officer's Representative (COR) for projects under this Agreement is:

The Secondary Contracting Officer's Representative (COR) for projects under this Agreement is:

The Primary and/or Secondary COR will be responsible for technical monitoring of the contractor's performance and deliveries. The COR and the Contractor's Representative shall work together to ensure that all contractual requirements are being met. The COR will interpret specifications or technical portions of the work. The COR is not authorized to perform, formally or informally, any of the following actions:

(1) Promise, award, agree to award, or execute any contract, contract modification, or notice of intent that changes or may change this contract;

(2) Waive or agree to modification of the delivery schedule;

(3) Make any final decision on any contract matter subject to the Disputes Clause;

(4) Terminate, for any reason, the contractor's right to proceed;

(5) Obligate in any way, the payment of money by the Government. Only a warranted Contracting Officer is authorized to obligate funds on this or any other contract action.

The contractor shall immediately notify the Contracting Officer in writing if the COR has taken an action (or fails to take action) or issues directions (written or oral) that the contractor considers to exceed the above limitations.

The contractor shall provide the Contracting Officer information copies of all correspondence to the COR.

B.10 FEDERAL HOLIDAYS

Unless specifically authorized in writing by the Contracting Officer, no services will be provided and no charges will be incurred and/or billed to any order on this contract on any of the Federal Holidays listed below.

B.11 INVOICES

a. Inspection and acceptance shall be accomplished as follows: The Government, for all services furnished under any resulting order, hereby designates the COR in the program office as the point of final inspection and acceptance. The BPA holder will submit each invoice, including all back-up data, to the Contracting Officer (CO) for review and signature. When the CO receives an accurate and complete invoice, he/she will return a signed copy to the BPA holder within five (5) working days. If the invoice is incomplete or inaccurate, the CO will return the unsigned invoice to the BPA holder for correction. The Contracting Officer will then forward the signed invoice to the Chief Financial Officer (CFO) for payment. Final payment for each order will be accomplished by final invoice accompanied by a receiving report.

b. An itemized invoice shall be submitted to the CO at least monthly or upon expiration of this BPA, whichever occurs first, for all deliveries made during a billing period and for which payment has not been received. Copies of delivery tickets shall support these invoices. "Approved-for-payment" invoices will be submitted to the payment address specified on each individual order issued under this BPA.

B.12 PRECEDENCE

36C24220Q0390 The Terms and conditions included in this BPA apply to all purchases made pursuant to it. In the event of an inconsistency between the provisions of this BPA and the Contractor's invoice, the provisions of this BPA will take precedence.

SECTION C - CONTRACT CLAUSES

C.1 RFQ INTRODUCTORY LANGUAGE

When a lower price has been established, or when the delivery terms, FOB terms, or ordering requirements have been modified by the BPA or task/delivery order, those modified terms will apply to all purchases made pursuant to it and take precedence over the FSS contract.

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within thirty (30) calendar days of the BPA expiration date.

(End of Clause)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within thirty (30) calendar days of the BPA expiration date; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least sixty (60) calendar days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years and six (6) months.

(End of Clause)

C.4 VAAR 852.247-72 MARKING DELIVERABLES (OCT 2018)

(a) The contract number shall be placed on or adjacent to all exterior mailing or shipping labels of deliverable items called for by the contract.

(b) Mark deliverables, except reports, for:

(End of Clause)

C.5 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

Material shall be packed for shipment in such a manner that will insure acceptance by common carriers and safe delivery at destination. Containers and closures shall comply with regulations of carriers as applicable to the mode of transportation.

36C24220Q0390 (End of Clause)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SOW

INTENT: Pursuant to Federal Supply Schedule (FSS) and FSS Contract Clause I-FSS-646, it is the intent of the Department of Veterans Affairs (herein afterwards referred to as VISN 2) to establish a Blanket Purchase Agreement (BPA) for Automated Blood Gas Instrumentation. The BPA shall be under the FSS Contract, Federal Supply Class (FSC) Group 66 III Cost Per Reportable Result (CPRR), Clinical Laboratory Analyzers. The Government will award a firm fixed-price BPA to a single Contractor for Automated Blood Gas Instrumentation. Contractor agrees to the following terms of the BPA exclusively with the VISN 2 facilities listed herein and awarded in the final BPA. However, as requirements change, facilities within VISN 2 may be added or deleted by supplemental agreement of the Government and the Contractor. Additional tests/reagents/instrumentation may be added to the BPA as new technology becomes available on the market and added to the base FSS contract.

ORDERS: This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the BPA by authorized individuals.

PRICES AND TERMS: VISN 2 will provide an estimated volume for each individual medical center. Pricing is based on the average daily test volume per instrument/analyzer for each facility. The Government estimates the volumes per facility as listed below but does not guarantee volumes listed; they are estimates only.

TERM OF AGREEMENT: This will be a single award, firm-fixed price BPA with one base year and an opportunity for four (4), one-year options. This BPA is not a contract. If the Contractor fails to perform in a manner satisfactory to the CO, this BPA may be canceled with thirty (30) days written notice to the Contractor by the CO. The Contractor shall also reserve the right to terminate the resultant BPA with 30 days notification to the CO. This BPA shall be reviewed annually. VISN 2 intends to establish the base year of the agreement for the period of October 1, 2020 through September 30, 2021.

IDENTIFICATION: Delivery Orders issued for the base year and any subsequent option years shall be identified by the applicable BPA Number.

ORDERING METHOD: The participating facilities may order products via Electronic Data Interchange (EDI), online, telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

SCOPE OF PROCUREMENT

A. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in this statement of work. The instrument shall be able to simultaneously perform the complete profile as described below to meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

B. Equipment must maintain, or peferably reduce the number of work-stations or overall labor required to accomplish the required testing by each laboratory.

C. If Contractor offers a family of analyzers, VISN 2 technical evaluation panel will determine if instrumentation proposed meets needs of using facility.

D. Equipment shall be acquired for each of the clinical laboratories located at the VISN facilities listed below.

E. 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.

F. 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.

II. DEFINITIONS

A. Cost Per Reportable Result (CPRR)- as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers - Contractors are required to provide a price for a reportable patient result. The per patient reportable result price shall include costs covering: (1) 5-year equipment use; (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation of a patient reportable result. This per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required producing a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI); (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs); and (4) training for Government personnel. Contractors shall provide delivery, installation and removal of equipment at no additional charge.

B. 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.

III. TEST MENU

A. Tests required to be included on proposed equipment are:

1. pH

2. pCO2

3. pO2

4. O2 sat

5. Base excess

6. Bicarbonate

7. Hemoglobin

8. Methemoglobin

9. Carboxyhemoglobin

10. Sodium

11. Potassium

12. Ionized calcium B. Analyzer shall be FDA approved to test Pleural Fluid for Ph C. Estimated Annual Testing

1. Albany yearly testing volume: 2625

2. Buffalo Yearly testing volume: 7000

3. Syracuse yearly testing volume: 1625

IV. GENERAL REQUIREMENTS

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. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all of the technical specifications of this SOW. Those additional analyzer(s) offered meeting the definition of a primary analyzer shall be equivalent to a back-up analyzer (see definition below) and shall replace the requirement for offering that category of equipment.

B. Back-up Analyzer; equipment required in support of operations for the VA laboratories in the event the primary analyzer(s) becomes non-operational/non-functional. This category of equipment shall only be operated during periods of time when the primary instrumentation is not available for use. As such, the requirements for consumable supplies, i.e. reagents, quality control material, calibrators, etc., shall be minimal and corollary to the successful operation of the primary instrumentation.

C. An internal and external barcode reader shall be supplied for each instrument provided.

D. 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).

E. If printer is integrated into analyzer, paper will be included at no additional cost.

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

G. 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.

H. 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.

V. TECHNICAL REQUIREMENTS: the instrumentation must be approved by the Federal Drug Administration (FDA) and shall have the following:

A. The equipment being offered shall be in current production as of the date of the offerors proposal is submitted and have been available commercially in the field for a minimum of one (1) year. For purposes of this statement of work, current production shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued equipment is not acceptable.

B. Equipment shall be new, state of the art, not used, recertified nor refurbished.

C. Safety features to avoid unnecessary exposure to biohazardous and chemical materials generated shall be nominal an require a minimum of handling.

D. Have an on-board quality control management system utilizing Windows 10 based operating system with a maximum capacity storage capacity of calibration data and quality control files to include Levy Jennings graphs. The analyzer must have the ability to capture, store and electronically transfer quality control data.

E. Analyzer must be capable of direct sampling from blood gas syringes and other blood collection tubes.

F. Analyzer must have the ability to use any Blood Gas syringe on the market.

G. Must employ an effective clot detection system to avoid instrumentation malfunction and inaccurate analysis.

H. Quality Control

1. Contractor will provide reliable and stable QC material.

2. Auto on-board QC, the ability to have QC run automatically at set intervals and auto rerun if QC is out of range.

3. Automatic on-board Quality Control must follow the entire measurement pathway including the entry port/sampling probe.

4. On board QC data management system to include Levy-Jennings graphs. Analyzer must have ability to download QC data for submission to an inter-laboratory comparison program.

5. Quality control data review and peer group reporting is provided by the vendor at no charge.

I. Calibration must be automatic or performed by a single technician within 5 minutes.

J. If proposed instrumentation is measurement cartridge-based, it should not take any longer than 30 to 45 minutes to bring a new cartridge to ready state.

K. Ability to connect to Data Innovations LIS interface bi-directionally.

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

M. Analyzer shall have a minimal daily startup routine and daily maintenance, such that the analyzer is not required to be down for more than 5 minutes per day. Analyzer shall afford easy access to perform maintenance.

VI. SERVICE AND MAINTENANCE REQUIREMENTS

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

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

C. Service engineers shall be available for each site. Service coverage at a minimum of Monday thru Friday 8am-5pm.

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

E. Agreement shall include labor and replacement of all parts found not to be functioning properly by contractor or customer.

VII. SUPPORT FEATURES

A. Implementation of the instruments across the VISN shall occur simultaneously no later than 60 days after award.

B. 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. The Contractor shall perform, to the satisfaction of the Government, all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The validation statistical data shall meet current standards defined by CLSI. This shall be done by the Contractor under the supervision of each VISN 2 laboratory designee to the satisfaction of their Medical Director. This shall occur subsequent to installation and must be completed no later than September 30, 2020.

C. Contractor will provide linearity material for validation and for the life of the contract. Linearity material must span the stated analytical measurement range, AMR.

D. Contractor will supply and uninterruptible power supply (UPS) with each analyzer.

E. 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.

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

VIII. REPORTS

A. 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.

IX. STANDARD AND QUALITY OF PERFORMANCE

A. 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.

B. 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.

C. 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.)

D. 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.

E. 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. [reference: Master FSS] F. 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.

G. During the term of the BPA, 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. [reference: Master FSS] Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment.

X. CHARACTERIZATION OF WASTE

A. 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.

B. The determination and description shall address the following:

1. Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

2. Waste ignitability (Reference 40 CFR §261.21)

3. Waste corrosivity (Reference 40 CFR §261.22)

4. Waste reactivity (Reference 40 CFR §261.23)

5. Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31)

6. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33)

7. Solid Waste (Reference 40 CFR §261.2)

8. Exclusions (Reference 40 CFR §261.4) C. 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.

n) pH

o) Flash point (to higher than 200F)

p) BOD; biochemical oxygen demand E. 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

XI. GOVERNMENT’S RESPONSIBILITY

A. 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.

XII. OWNERSHIP OF EQUIPMENT

A. 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.

B. 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.

C. Prior to termination or completion of this BPA, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this BPA 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 BPA.

D. 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 BPA 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 BPA or disposal or return of the IT equipment, whichever is earlier.

E. 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.

F. 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:

1. 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

2. 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.

3. 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.

Attachment A – Delivery Information and Required Tests Individual Orders: Delivery orders and purchase orders shall be issued by a Contracting Officer. No other methodology for ordering is acceptable. Only Contracting Officers have the authority to award delivery orders and purchase orders.

Delivery: Delivery is required within five (5) calendar days after receipt of an order for all delivery orders and the corresponding purchase orders issued against the awarded BPA. All deliveries shall be made to the following addresses:

Syracuse VA Medical Center Attention: Pathology & Laboratory Medicine 800 Irving Avenue Syracuse, NY 13210

Shipping: All orders placed against the awarded BPA are to be shipped FOB Destination without any exceptions.

Invoicing: The obligation of funds shall occur at the delivery order level. Each delivery order shall have a corresponding purchase order. To receive payment, the Contractor must invoice against the purchase order associated with the corresponding delivery order. Invoices must be submitted electronically through the Tungsten Network against the correct purchase order number and must include the following: the order date, the order number or the invoice number, and an itemized bill that clearly indicates what is being invoiced.

Base Year: October 1, 2020 – September 30, 2021

Option Year Two: October 1, 2022 – September 30, 2023

Option Year Three: October 1, 2023 – September 30, 2024

Option Year Four: October 1, 2024 – September 30, 2025

FACTORS

The offeror’s proposal shall, at the minimum, address each of the factors listed in this RFQ.

During evaluations of each quote, the Government will assess each area of the Technical Quote to ensure the offeror meets or exceeds the standards of the BPA. The Government will evaluate the technical quote based on the evaluation criteria described in the Evaluation Section below, as well as those requirements listed in the Statement of Work.