36C26021Q0501.docx

36C26021Q0501

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

36C26021Q0501 04-2 -2021 Ross Byrne 253-888-4922 04- -2021 11:00 am

PDT

Department of Veterans Affairs Network Contracting Office 20 5115 NE 82nd Ave, Suite 102 Vancouver WA 98662 X 325413 1250 Employees Net 30 Days N/A X Department of Veterans Affairs Portland VA Medical Center Warehouse 3710 SW U.S. Veterans Hospital Rd.

Portland OR 97239 Y Department of Veterans Affairs Network Contracting Office 20 5115 NE 82nd Ave, Suite 102 Vancouver WA 98662

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center

PO BOX 149971

Austin TX 78714-9971 See CONTINUATION Page Contractor shall provide Automated Blood Gas Instrument(s) CPT/CPRR Reagents & Consumables in accordance with the Statement of Work at the Portland VA Medical Center.

This solicitation will result in a Single Award Indefinite Delivery Indefinite Quantity (IDIQ) five-year contract.

Individual Task Orders will be issued by the NCO 20 Contracting Office.

Period of Performance: 05/31/2021 to 05/30/2026.

This procurement is being competed in accordance with FAR Part 13 Simplified Acquisition Procedures See CONTINUATION Page X X X One Ross Byrne Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR: To Be Determined

b. GOVERNMENT: Contracting Officer 36C260 Department of Veterans Affairs Network Contracting Office 20 5115 NE 82nd Ave, Suite 102 Vancouver WA 98662

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.

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center

PO BOX 149971

Austin TX 78714-9971

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

6.0. GOVERNMENT INVOICING INSTRUCTIONS: Invoicing shall be in accordance with the requirements of The Department of Veterans Affairs (VA) Financial Services Center (VAFSC). The latest information shall be used for invoicing and payments and may change during the Period of Performance of this acquisition. Invoice requirements are currently as follows: Invoice Number, Invoice Date, Purchase Order Number, Unit Price, Quantity and Unit of Measure, Total Invoice Price, Ship-To Location Name and/or code, Receipt of Goods/ Services, Invoice Payment Terms.

Current Invoicing information is located at http://www.fsc.va.gov/einvoice.asp. It states:

6.1. FSC Mandatory Electronic Invoice Submission: The Department of Veterans Affairs published a final rule in the Federal Register on November 27, 2012 to require contractors to submit payment requests in electronic form in order to enhance customer service, departmental productivity, and adoption of innovative information technology, including the appropriate use of commercial best practices. The rule is effective December 27, 2012.

6.2. Vendor Electronic Invoice Submission Methods

Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below:

6.2.1.VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

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

The X12 EDI Web site (http://www.x12.org).

6.3. Vendor e-Invoice Set-Up Information:

Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below:

•Tungsten e-Invoice Setup Information: 1-877-489-6135 •Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com •FSC e-Invoice Contact Information: 1-877-353-9791 •FSC e-invoice email: vafsccshd@va.gov

B.2 ORDERING PROCEDURES

An initial Task Order for Automated Blood Gas Instrument(s) CPT/CPRR Reagents and Consumables will be issued by the Veterans Affairs (VA) Contracting Officer at the beginning of the contract’s period of performance. The Task Order will be emailed to the Contractor. The VA anticipates funding one Task Order per 12-months. The Government reserves the right to award task orders for shorter periods, when necessary. Any Task Order that needs to be increased or decreased due to higher or lower than expected quantities, a Modification will be done to the prices stated on the price schedule. Task Orders will be bulk funded so that funds are already available when the VA requires services. Do not exceed the amount bulk funded without first receiving a contract modification. VA’s requests for Automated Blood Gas Instrument(s) CPT/CPRR Reagents and Consumables will be in accordance with the Statement of Work.

B.3 MINIMUM / MAXIMUM

In accordance with FAR 16.504(a)(4)(ii): The guaranteed minimum contract quantity is $1,280.00. The maximum quantity shall not exceed $396,000.00. The Government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum award amount.

B.4 PRICE/COST SCHEDULE

GRAND TOTAL

B.5 STATEMENT OF WORK:

1.0 Title: Automated Blood Gas Instrumentation CPT/CPRR Reagents and Consumables

2.0 Background: The VA Portland Health Care System requires a Contractor to provide high capacity Blood Gas Instruments via a Cost Per Test (CPT) & Cost Per Reportable Results (CPRR) contract. The Contractor shall provide all required instrument(s) to the Government, free of charge. The contract for these CPT instruments must include the instrument(s), training, service, all reagents and consumable supplies required to perform blood gas analysis. The instruments must measure venous and arterial blood pH, pCO2, pO2, Sodium, Potassium, Chloride, Lactic Acid, Ionized Calcium, Total Hemoglobin and derivatives, and Pleural Fluid pH and report calculated values for Bicarbonate, Base Estimate of Blood, Ionized Calcium Corrected for pH, Patient Temperature Correction for pH, pCO2 & pO2, Hemoglobin Oxygen Saturation, Total Oxygen Content, and Anion Gap. In addition, the instruments must perform calibration and three levels of Quality Control analysis automatically at predetermined times.

2.1.1. The Contractor shall provide the facility with Food and Drug Administration (FDA) approved analyzer/equipment and printer, reagents, controls, calibrators, linearity material, disposables, any consumable parts or supplies necessary for analyzing/testing, and printing results from the analyzer and services as described herein to VAPORHCS in accordance with the applicable Federal Supply Schedule contract. Contractor shall list the consumable parts provided. Contractor shall state any parameter/function that is pending FDA approval at the time of the submission.

2.1.2. A listing of the estimated yearly quantity is provided under this agreement located in Attachment 1 (Test Menu and Volumes). Quantities listed in the attachment are estimates based upon prior history of actual volumes and are intended to provide the potential contractor a basis for calculating their pricing. They are not a guaranteed minimum. These volumes can be utilized by interested contractors to submit their cost proposal.

2.1.3. The pricing shall be based on new state-of-the-art equipment. Remanufactured or used models will not be accepted. The Contractor’s quoted equipment shall conform to the facilities existing space. Each instrument’s size shall be not greater than 24 inches wide, 24 inches high, and 24 inches deep due to current space constraints in the laboratory.

2.1.4. The Contractor shall 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.

2.1.5. 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.

2.1.6. The analyzer/equipment must meet the test volume in Attachment 1 (Test Menu and Volumes) and match or improve the turnaround time requirements. The system should streamline all aspects of testing, thereby improving efficiency and productivity of the using facility.

2.2. DEFINITIONS:

2.2.1. Cost per Patient Reportable Result (CPRR)- 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.

2.3. TEST MENU: Refer to Attachment A for desired test menu and estimated annual volumes.

2.4. GENERAL REQUIREMENTS:

2.4.1. Primary analyzer(s) – 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 the technical specifications of this solicitation. 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.

2.4.2. Back-up Analyzer(s) - Equipment required in support of operations for the VA laboratory 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.

2.4.3. Technical Features - The desired blood gas/critical care metabolite instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the capability of performing or reporting the following parameters (FDA approved) on arterial, venous, or mixed venous whole blood specimens: pH, pO2, pCO2, hemoglobin, sodium, potassium, chloride, ionized calcium and/or normalized calcium, glucose, lactic acid, base excess, bicarbonate, total carbon dioxide (TCO2), oxygen saturation and co-oximetry, including Oxyhemoglobin, Carboxyhemoglobin, and Methemoglobin. In addition, the instrumentation must be approved by the FDA for performing and reporting pH measurements on Pleural Fluids. The instrument must be able to perform the complete profile described above discretely by either direct or indirect (calculated) measurement and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical Laboratory Standards Institute (CLSI). In addition, the analyses must take place on a single instrument and a single specimen.

2.4.4. Operational Features – The instrumentation offered shall have the following:

2.4.4.4 Quality Control Material/System that shall:

2.4.4.4.1 Include 3 levels of controls that represent both high and low values for each analyte tested.

2.4.4.4.2 Quality Control should be processed using the same pathway as patient samples.

2.4.4.4.3 Volume of external and/or internal on-board quality control material to meet the daily quality control requirements for every 24 hours of operation.

2.4.4.4.3.1 For analysis every 8 hours of operation and,

2.4.4.4.3.2 For troubleshooting\, as needed.

2.4.4.4.4 The contractor shall explain the external and/or internal QC testing process and its frequency for the proposed instrumentation.

2.4.4.5 A quality assurance system that shall:

2.4.4.5.1 Automatically perform system checks and/or system calibrations in accordance with the minimum regulatory requirements.

2.4.4.5.2 Monitor temperature and barometric pressure. The calibration shall compensate for the influence of barometric pressure.

2.4.4.5.3 Allow the operator to preprogram the analysis of quality control material.

2.4.4.5.4 Perform automatic corrective action on the system if the results of the quality control testing are not acceptable.

2.4.4.6. A diagnostic error detection system that shall:

2.4.5. Hardware Features – The instrumentation quoted shall have the following:

2.4.5.1. A sample path design that allows for easy fibrin clot removal without hardware disassembly.

2.4.5.2. An on-board, adjustable screen/ monitor that is easily readable.

2.4.5.3. A total equipment footprint that, when installed in the laboratory, shall not impact the functionality / operations of that laboratory.

2.4.5.4. A printer that has the capability of printing a patient report with patient demographic information that includes minimally the accession or unique identifier number (UID). Replacement printers shall be provided as needed, at no additional charge, for the duration of the contract.

2.4.5.5. An uninterruptible power supply with line conditioner for each instrument provided under this contract. Replacement uninterruptible power supply with line conditioners shall be provided as needed, at no additional charge, for the duration of this contract.

2.4.5.6. An equipment mean failure rate of greater than 60 days.

2.4.5.7. Upgrades to both the equipment hardware and software in order to maintain the integrity of the system and state-of-the-art technology at no additional charge to the Government. This requirement only applies to ‘system upgrades’ that enhance the model of the equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer vendor supported, etc.

2.4.6. Method Performance/Validation Requirements

2.4.6.1. Method performance/comparison shall be at the expense of and performed by the contractor, and shall include linearity material, reagents, and controls, and be consistent with current CLSI guidelines related documents, College of American Pathologist (CAP) standards, and Federal regulations.

2.4.6.2. All studies performed will be appropriate for the required tests menu and sample type, i.e., arterial, venous, and mixed whole blood.

2.4.6.3. The studies must be approved by the Laboratory Director and be made available electronically.

2.4.6.4. These requirements shall be in effect during installation and any future changes to the test menu and/or method updates.

2.4.6.5. The required studies are:

2.4.6.5.1. Correlation studies for each analyte. A minimum of 20 samples spanning the reportable range, shall be run by the present and the proposed method. In systems where multiple sampling modes exist, mode to mode correlation studies must also be performed. Contractor shall analyze results and provide statistical data to support acceptance of the new method for above studies. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, ROC analysis, and meet current standards defined by CLSI.

2.4.6.5.2. Analytical Measurement Range (AMR) Validation shall be performed on proposed instrument(s) for each analyte to validate the reportable range. The material must have values, which are near the low, mid, and high values of the AMR and be of appropriate matrix for the clinical specimens assayed by that method. A minimum 5-point linearity analysis that adheres to the Beer-Lambert Law and spans the entire reportable range shall be performed as a minimum.

2.4.6.5.3. Precision study using normal and abnormal control material. This shall consist of a within run precision study of 10 normal and 10 abnormal controls and a day-to-day precision study of normal controls and abnormal controls for 10 days (may be run twice a day) for a total of 20 values per level of control.

2.4.6.5.4. Specificity Studies. A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances.

2.4.6.5.5. Carryover Studies. Successful carryover studies shall be completed by the Contractor on all analyzers during installation. These studies shall be performed using either contractor developed program(s) or program(s) developed by a third party (CAP/CLSI). The programs shall be provided to each laboratory at no charge.

2.4.6.5.6. Internal Barometer Check. If the instrument has an internal barometer, its function should be checked by comparing its values to a reliable independent measurement on installation and per the manufacturer’s guideline. This check shall be performed by the Contractor.

2.4.6.5.7. A reference range must be determined for each test following CLSI guidelines. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each lab. One of the following protocols shall be used:

2.4.6.5.8. A verification of the manufacturer’s suggested reference range may be performed if the suggested range is based on a comparable population of test subjects. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 20 reference individuals shall be used to verify the manufacturer’s range. Any apparent outliers should be discarded, and new specimens obtained to provide a statistically valid verification.

2.4.6.5.8.1. If the suggested manufacturer’s range is not appropriate for the patient population, a reference range shall be established. Establishing a reference must follow CLSI guidelines. This requires a minimum of 120 reference individuals to be used to establish a reference range. The reference interval should be determined using the nonparametric method.

2.4.6.5.8.2. If a laboratory is currently using the proposed instrument/reagent system, the “in-use” reference range can be transferred to the “new” system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, one of the two above items must be performed.

2.4.7. Support Features

2.4.7.1. Commercial marketing. The equipment models being provided shall be in current production as of the date this offer is submitted. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

2.4.7.2. 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 assist the Government with validation and method comparison studies. All materials and reagents needed for such correlation shall be provided at no cost to the Government. The Contractor shall perform all of the statistical analysis and report data in an organized, clearly comprehensible format. This process shall be completed within two weeks of installation of the analyzer at each site and shall be consistent with current CLSI and related documents, CAP Standards and Federal Regulations.

2.4.7.3. 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 defined in the contract. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally one operator 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.

2.4.7.4. Equipment Preventative Maintenance/Repair Service.

2.4.7.4.1. A technical assistance center must be available 24 hours per day, 7 days per week, with a maximum call back response time of 1 hours.

2.4.7.4.2. The Contractor must provide on-site service 24 hours per day, 7 days per week on all instruments placed. The maximum response time for on-site service will be 24 hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.

2.4.7.4.3. Preventative maintenance will be performed on-site as frequently as published in the manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.

2.4.7.4.4. 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:

2.4.7.4.4.1. Date and time notified

2.4.7.4.4.2. Date and time of arrival

2.4.7.4.4.3. Serial number, type and model number of equipment

2.4.7.4.4.4. Time spent for repair, and

2.4.7.4.4.5. Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

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

Ancillary support equipment.

The Contractor shall provide, install and maintain through the life of the BPA, as indicated, 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.

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.

2.4.7.5. Interface Requirements – Not Applicable

The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system.

2.4.7.5.1.1. The Contractor shall provide all necessary software support for ensuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself

2.4.7.5.1.2. If a site already has a universal interface box, the Contractor is responsible for everything leading up to the box including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system.

2.4.7.5.1.3. If a site does not have a universal interface and one is needed to optimally interface the instrument, then the Contractor is responsible for the acquisition of the universal interface box and everything else needed to connect with VA computerized hospital information system.

2.4.7.5.1.4. If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system.

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. Computer disc containing their procedure manual in CLSI format or an on-line procedure manual in the instrument software.

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, thimerosal 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 Contractor response:

2.4.7.5.15. pH

2.4.7.5.16. Flash point (to higher than 200F)

2.4.7.5.17. BOD; biochemical oxygen demand

2.4.7.5.17.1. The documentation the Contractor provides shall be used to work with the Portland VAMC and the public and/or private organization (e.g., POTW) to determine whether the waste from each device can legally be disposed of via the sewerage system Implementation/transition timeframe - Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 60 days for the transition of all services under the awarded contract including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate contract for cause under the Termination for Cause clause of the contract. At the end of 60 days from award of the contract, the Contractor shall have full and sole responsibility for services under the awarded contract.

Standard and Quality of Performance- This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the contract 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 the contract at an effectiveness level of 90% or more.

2.4.7.5.18. 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.

2.4.7.5.19. 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.)

2.4.7.5.20. 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.

2.4.7.5.21. 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.

2.4.7.5.22. 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.

2.4.7.5.23. 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 Contracting Officer Representative (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.

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

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.

2.4.7.5.25. The Contractor shall 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.

2.4.7.5.26. Prior to completion of this contract, Contractor/subcontractor 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.

2.4.7.5.27. 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

2.4.7.5.28. 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:

2.4.7.5.29. Contractor must accept the system without the drive;

2.4.7.5.30. 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

2.4.7.5.31. VA must reimburse the Contractor for media at a reasonable open market replacement cost at time of purchase.

2.4.7.5.32. 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;

2.4.7.5.33. 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

2.4.7.5.34. 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 contract.

2.4.7.5.35. 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: Test Menu and Volumes

Measured Analytes

Calculated Analytes

Bicarbonate

Base Estimate of Blood

Ionized Calcium Corrected for pH

Patient Temperature Correction for pH, pCO2 & pO2

Hemoglobin Oxygen Saturation

Total Oxygen Content

Anion Gap

SECTION C - CONTRACT CLAUSES

C.1 52.203-19 PROHIBITION ON REQUIRING CERTAIN INTERNAL CONFIDENTIALITY AGREEMENTS OR STATEMENTS (JAN 2017)

(a) Definitions. As used in this clause— Internal confidentiality agreement or statement means a confidentiality agreement or any other written statement that the contractor requires any of its employees or subcontractors to sign regarding nondisclosure of contractor information, except that it does not include confidentiality agreements arising out of civil litigation or confidentiality agreements that contractor employees or subcontractors sign at the behest of a Federal agency.

Subcontract means any contract as defined in subpart 2.1 entered into by a subcontractor to furnish supplies or services for performance of a prime contract or a subcontract. It includes but is not limited to purchase orders, and changes and modifications to purchase orders.

Subcontractor means any supplier, distributor, vendor, or firm (including a consultant) that furnishes supplies or services to or for a prime contractor or another subcontractor.

(b) The Contractor shall not require its employees or subcontractors to sign or comply with internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting waste, fraud, or abuse related to the performance of a Government contract to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information (e.g., agency Office of the Inspector General).

(c) The Contractor shall notify current employees and subcontractors that prohibitions and restrictions of any preexisting internal confidentiality agreements or statements covered by this clause, to the extent that such prohibitions and restrictions are inconsistent with the prohibitions of this clause, are no longer in effect.

(d) The prohibition in paragraph (b) of this clause does not contravene requirements applicable to Standard Form 312 (Classified Information Nondisclosure Agreement), Form 4414 (Sensitive Compartmented Information Nondisclosure Agreement), or any other form issued by a Federal department or agency governing the nondisclosure of classified information.

(e) In accordance with section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015, (Pub. L. 113-235), and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions) use of funds appropriated (or otherwise made available) is prohibited, if the Government determines that the Contractor is not in compliance with the provisions of this clause.

(f) The Contractor shall include the substance of this clause, including this paragraph (f), in subcontracts under such contracts.

(End of Clause) C.2 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2021)

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

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

(2) 52.204–23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115–91).

(3) 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (AUG 2020) (Section 889(a)(1)(A) of Pub. L.