36C24625Q0061_1.docx

36C24625Q0061

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.

UEI:

EFT:

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. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

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

652-25-1-096-0043 36C24625Q0061 10-04-2024 Jo Ann Harris 757-722-9961 x18882 10-11-2024

10:00 AM

EDT

Veterans Affairs Medical Center Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667 X 339112 1000 Employees N/A X Richmond Veterans Affairs Medical Center 1201 Broad Rock Blvd.

Lab 113 Richmond VA 23249 Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667

Department of Veterans Affairs Financial Services Center

PO BOX 149971

Austin TX 78714-9971 512-460-5049 512-460-5221 X See CONTINUATION Page The Richmond VAMC intends o solicit for a Viscoelastic Testing Instrumentation System & Supplies Brand Name or Equal All offerors shall be registered and current in the System for Award Management (SAM) database at time of offer submission and maintain active registration until contract award, completion of performance, and final payment.

Period of Performance: 11/18/2024 - 11/17/2029 A 12 month base plus four (4) annual option years Firm Fixed Price Contract will result from this solicitation.

Please follow all instructions in Section E.

Please submit all attachments in section D with the quote.

Please complete Block 17a, and sign Block 30a, 30b, and 30c of the SF 1449. Submit all technical and operational information per the Statement of Work, and the Instruction Statement of Work and the Instructions to Offerors in Section E of this solicitation.

See CONTINUATION Page X X X Cherisse Hall Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C246 Cherisse Hall

Veterans Affairs Medical Center Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667

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.

VA Financial Service Center (FSC) Electronic Invoice Presentment and Payment System https://www.fsc.einvoice.asp ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

Monthly lease for instrument, cart, and service billing.

Contract Period: Base POP Begin: 11-18-2024 POP End: 11-17-2025 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

0001AA

Monthly lease for instrument, cart, and service billing.

Contract Period: Option 1 POP Begin: 11-18-2025 POP End: 11-17-2026

0001AB

Monthly lease for instrument, cart, and service billing.

Contract Period: Option 2 POP Begin: 11-18-2026 POP End: 11-17-2027

0001AC

Monthly lease for instrument, cart, and service billing.

Contract Period: Option 3 POP Begin: 11-18-2027 POP End: 11-17-2028

0001AD

Monthly lease for instrument, cart, and service billing.

Contract Period: Option 4 POP Begin: 11-18-2028 POP End: 11-17-2029

Cartridge complete + hep Kit

POP Begin: 11-18-2024 POP End: 11-17-2025

0002AA

Cartridge complete + hep Kit

POP Begin: 11-18-2025 POP End: 11-17-2026

0002AB

Cartridge complete + hep Kit

POP Begin: 11-18-2026 POP End: 11-17-2027

0002AC

Cartridge complete + hep Kit

POP Begin: 11-18-2027 POP End: 11-17-2028

0002AD

Cartridge complete + hep Kit

POP Begin: 11-18-2028 POP End: 11-17-2029

Rotrol N, 5/bx

POP Begin: 11-18-2024 POP End: 11-17-2025

0003AA

Rotrol N, 5/bx

POP Begin: 11-18-2025 POP End: 11-17-2026

0003AB

Rotrol N, 5/bx

POP Begin: 11-18-2026 POP End: 11-17-2027

0003AC

Rotrol N, 5/bx

POP Begin: 11-18-2027 POP End: 11-17-2028

0003AD

Rotrol N, 5/bx

POP Begin: 11-18-2028 POP End: 11-17-2029

ROTROL P, 5/bx

POP Begin: 11-18-2024 POP End: 11-17-2025

0004AA

ROTROL P, 5/bx

POP Begin: 11-18-2025 POP End: 11-17-2026

0004AB

ROTROL P, 5/bx

POP Begin: 11-18-2026 POP End: 11-17-2027

0004AC

ROTROL P, 5/bx

POP Begin: 11-18-2027 POP End: 11-17-2028

0004AD

ROTROL P, 5/bx

POP Begin: 11-18-2028 POP End: 11-17-2029

IT solutions silver

POP Begin: 11-18-2024 POP End: 11-17-2025

0005AA

IT solutions silver

POP Begin: 11-18-2025 POP End: 11-17-2026

0005AB

IT solutions silver

POP Begin: 11-18-2026 POP End: 11-17-2027

0005AC

IT solutions silver

POP Begin: 11-18-2027 POP End: 11-17-2028

0005AD

IT solutions silver

POP Begin: 11-18-2028 POP End: 11-17-2029

36C24625Q0061

Page 1 of Page 1 of

B.3 STATEMENT OF WORK

1.0 CONTRACT LANGUAGE

1.1 INTENT: It is the intent of the Richmond VA Medical Center, located at 1201 Broad Rock Blvd, Richmond, VA 23249, to establish a contract for new Viscoelastic Testing Instrumentation for Point of Care use with an integrated Information Management System. The term of the contact shall be a base year plus 4 option years. New instrumentation shall be leased, and consumables priced on a cost per reportable result basis.

1.2 PRICES AND TERMS: An estimated usage for the Richmond VA Medical Center is 210 tests per year. This quantity is based upon projected use and is intended to provide the potential Contractor a basis for calculating their pricing. The Government does not guarantee this volume, 210 tests is an estimate ONLY.

1.3 ORDERING METHOD: The participating facility may order products via telephone, facsimile, email, online, or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

1.4 BILLING: Invoices shall be submitted monthly, in arrears, through the OB10/Tungsten system.

2.0 DESCRIPTION/SPECIFICATIONS/SATEMENT OF WORK

2.1 SCOPE OF PROCUREMENT:

2.1.1 The required viscoelastic testing instrument system shall have the capability of performing and reporting the clinical parameters as defined in the statement of work on arterial, venous, or mixed blood whole blood specimens. The analysis shall take place on a single instrument with a single specimen.

2.1.2 The preferred viscoelastic testing instrument system shall be able to directly interface with at least one of the current VA laboratory middleware systems currently in use at Richmond VAMC (GEMWeb plus or Unipoc). The middleware system shall at a minimum notify personnel of pending results, manage patient and quality control data, store records, and provide remote access to the testing instruments. The Contractor shall describe how the middleware will alert the staff that a sample is pending review and verification.

2.1.3 The viscoelastic testing instrument(s) shall be able to perform the complete profile and 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).

2.1.4 The Contractor shall furnish all clinical laboratory supplies and services as described herein to the participating VAMC facility.

2.1.5 The proposed viscoelastic testing instrument system shall have at least one-year proven experience at the time of proposal submission and be FDA cleared. The Contractor shall list any parameter or specimen type that is not FDA approved.

2.1.6 The Contractor may provide the option in their pricing schedule to allow the Richmond VA Medical Center to choose the analyzer(s) that is best suited to their laboratory with mirror image redundancy. The technical evaluation panel will determine if the instrumentation proposed meets the needs of their facility.

2.1.7 The pricing shall be based on new equipment. Remanufactured or used models will not be accepted. The Contractor’s offered equipment shall conform to the facility’s existing space. The Contractor shall provide the dimensions of their proposed analyzer(s) and data management system.

2.1.8 The Contractor must be aware that since this contract is for a total of 5 years that there is the possibility that the facility may require equipment installation and possible reinstallation due to demolition, new construction, laboratory redesign, and/or relocation. The contractor shall provide this relocation/reinstallation service if needed.

2.1.9 The Contractor is required to provide the facility with a continuously stocked inventory of reagents, standards, controls, calibrators, linearity material, supplies, replacement parts, disposables and any other materials required to properly perform tests on the equipment (both primary and back-up analyzers) such that equipment operations are not interrupted for the duration of the contract. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. The expiration dates must be clearly marked on the reagents, standards, and quality control containers. Unexpected changes in methodology and/or 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.

2.1.10 The vendor shall describe the process for routine supply orders and all supplies required to perform the full requested test menu. The description shall include the following for each consumable:

2.1.10.1 Cubic foot based on proposed test menu.

2.1.10.2 Storage requirements (refrigerated, frozen & room temperature)

2.1.10.3 Estimated shelf-life (i.e. expiration dates)

2.1.11 The contractor shall describe their process for handling emergency supply orders:

2.1.11.1 Defective and unsuitable for use with the Contractor’s equipment

2.1.11.2 Contractor’s failure to comply with the requirements for routine supply delivery.

2.1.11.3 Government’s failure to place orders within the routine/standing order timelines

2.2 DEFINITIONS:

2.2.1 Cost per Patient Reportable Result (CPRR) - Contractors are required to provide a price for a reportable patient result. The cost per patient reportable result price shall include costs covering:

· Five (5) years of equipment use.

· All reagents, standards, quality controls, calibrators, linearity material, supplies, consumable/disposable items, replacement 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 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).

· All necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs).

· Training for Government personnel.

Contractors shall provide delivery, installation, and removal of equipment at no additional charge.

2.2.2 Parameter definitions –

· Viscoelastic testing is a method of hemostatic analysis that provides a real-time, holistic view of ex vivo clotting

· Parameters include, but may not be limited to, time of onset of fibrin formation, the rate of fibrin formation, the strength of the fibrin clot, and fibrinolysis at defined endpoints

2.2.3 Business Associate Agreement (BAA) - A business associate agreement 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 Protected Health Information (PHI) or that provides certain services involving the disclosure of PHI. VHA is a covered entity under the Health Insurance Portability and Accountability Act (HIPAA) 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 BAA’s obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule.

2.3 TEST MENU:

The viscoelastic testing instrument system shall have the capability of performing and reporting, at minimum, the following parameters on arterial, venous, or mixed venous whole blood specimens on one cartridge, using one sample:

· Time to onset of fibrin formation

· Rate of fibrin formation

· Strength of fibrin clot

· Fibrinolysis at defined endpoints

The Contractor may list any other parameter that is currently available to be analyzed on their proposed equipment.

2.4 GENERAL REQUIREMENTS

2.4.1 Primary and Back-up 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, multiple analyzers may be required due to the criticality of the tests being performed and to ensure adequate backup during a medical emergency. In those instances, the additional back-up analyzer(s) shall, likewise, be considered primary instrumentation and be the mirror image of the primary instrumentation and shall meet all the technical specifications of this solicitation. The analyzers shall be capable of operating independently of each other.

2.4.2 The Contractor shall provide the facility, for the duration of the contract, all linearity material, calibration verification material, or any commercial system correlation samples needed to validate equipment performance to meet CAP requirements for accreditation.

2.4.3 The systems shall have standardization of software, hardware, reagents, and consumables between the primary and back-up analyzer(s) throughout the facility (mirror image redundancy).

2.4.4 The Contractor shall describe the quality control requirements of their system to include all quality system checks in the pre-analytical, analytical, and post-analytical phases of testing. The vendor shall also provide external and/or internal on-board commercial quality control material to meet the daily quality control (QC) requirements for every 24 hours of operation if required by the instrument or per the Individualized Quality Control Plan (IQCP) requirements of the facility if required.

If quality control is required, the vendor’s proposal shall include:

· 3 levels for viscoelastic testing,

· 2 levels at a minimum for critical care metabolites/Chemistry,

· 3 levels for co-oximetry The Contractor shall explain the internal and/or external QC testing process and the frequency for their proposed equipment. The vendor shall provide all quality control material as required for proposed equipment and to be analyzed on each analyzer(s) within the terms of operation. The daily control material shall represent both high and low values on each day of patient testing.

2.4.5 The vendor shall describe the control stability. Controls should have the longest possible dating to minimize the frequency of lot changes and changes to controls.

2.4.6 The contractor shall provide a way to monitor for analytic imprecision initially and throughout the QC life of the QC lot if QC is required.

2.4.7 The equipment and/or QC/data management system shall have on-line documentation for quality control outliers, instrument issues, troubleshooting, etc. The vendor shall describe the system for QC management.

2.4.8 The viscoelastic testing instruments shall perform within the defined Limits of Acceptability on the College of American Pathologists (CAP) Proficiency Testing (PT) surveys. The Contractor shall provide information if the PT samples must be tested or handled in a different way for proficiency testing.

2.4.9 The vendor shall describe their Quality Assurance program and the process for peer participation. The program may have at least 50 participants, automatic electronic data upload capability of analyzer quality control to peer group and be provided at no additional cost to the government. Reports of peer data shall be current and available within 1-2 weeks of the data submission for hard copy review.

2.5 OPERATIONAL FEATURES

2.5.1 At minimum, the proposed instrumentation shall have the capacity to perform analysis for the following parameters: time of onset of fibrin formation, the rate of fibrin formation, the strength of the fibrin clot, and fibrinolysis at defined endpoints.

2.5.2 The required equipment shall be capable of producing accurate and reproducible results by established diagnostic methods. The equipment shall provide accurate tests results without excessive malfunctions, breakdowns, or service calls. The equipment shall have an uptime of at least 90% in each month of the term of the agreement for equipment. Past performance expectations can be found in section 2.18 of this document.

2.5.3 The viscoelastic testing system shall have sufficient safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be provided by the company.

2.5.4 The equipment shall have positive sample identification, random access, and accurate barcode reading to reduce possible sources of errors and to improve laboratory efficiency.

2.5.5 The equipment must be able to support multiple barcode formats (including but not limited to: Code 39, Code 128) that may be enabled concurrently.

2.5.6 The equipment must accept, at a minimum, a 10-character specimen identifier that is that is alphanumeric (letters and numbers).

2.5.7 The viscoelastic testing system shall require less than one hour to perform daily, monthly, and periodic maintenance. The Contractor is to define the actual hands-on time required to perform each task and what materials and/or items are required/provided to perform each task. The Contractor is to describe the analyzer time required to perform each maintenance task.

2.5.8 The viscoelastic testing equipment shall have the ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage. The equipment shall have the ability to edit the sample/patient identifier after interface downtime and then be able to resend the sample/patient information to the host for verification. The vendor shall describe the data management storage and transmission capabilities.

2.5.9 The system shall monitor temperature and barometric pressure. The analyzer(s) may have the ability to function in a broad range of humidity and temperature conditions. The Contractor shall supply the environmental requirements (i.e., humidity and temperature) for the proposed equipment to perform satisfactorily in the laboratory.

2.5.10 The instrument shall not be sensitive to vibration.

2.5.11 Then instrument shall be capable of actively warming a sample to the temperature necessary for accurate testing.

2.5.12 The viscoelastic testing analyzer(s) shall perform system checks and/or system calibrations in accordance with the regulatory requirements. The calibration shall compensate for the influence of barometric pressure. The system shall have a diagnostic error detection system that will alert the operator of a calibration drift. The Contractor shall specify the frequency of a one point, two point, and system calibration.

2.5.13 The viscoelastic testing analyzer(s) shall have on board reagent monitoring. The system shall be capable of monitoring reagent usage and provide reagent inventory upon request, in real time. The system shall have the ability to detect and alert the operator of low liquid levels and the potential of depletion for any supply on the analyzer.

2.5.14 Reagent cartridges shall have at least 12 months shelf life at room temperature, 18°C-25°C. The Contractor shall list all reagents used for viscoelastic testing and state the shelf life and on-board stability/expiration date for all reagents, controls, and calibrators.

2.5.15 The Contractor shall state the size of the reagents, controls, and calibrators and if they are stored at room temperature or refrigerated. The Contractor may state if the reagents are color coded. Packaging should be maximized to accommodate the workload volume and reduce the amount of storage space needed. The Contractor shall monitor reagent inventory to prevent overstock.

2.5.16 Reagents shall be interchangeable between the primary analyzer and the back-up analyzer.

2.5.17 The Contractor shall work with each facility to adjust reagent supply to match workload changes and to provide the option for each facility to establish a quarterly shipment table. The Contractor shall work with the facility annually to adjust the shipment table if needed.

2.5.18 Contractor shall be flexible in reference to changing standing orders or adding additional supplies. The contractor shall state what their policy is in regard to adjusting a standing order or ordering an additional shipment of supplies (i.e. Is there an additional fee charged for changing the standing order, is there a limit to the number of times you can adjust a standing order, or is there a fee for the additional shipment of supplies).

2.5.19 The viscoelastic testing analyzer(s) must have a sampling system that can aspirate directly from an evacuated blood collection tube that can accommodate any sample type without any additional adapter devices. The sampling system must have the capability of walk away processing that negates the need for additional instrument prompting. The Contractor shall state the sample size required for patient testing and if a specific sample syringe must be used for patient testing.

2.5.20 The sampling system shall have an early clot detection that alerts the operator to the suspected existence of a fibrin clot in the specimen that would question the sample integrity. The Contractor shall explain the mechanism to detect a clotted specimen. The Contractor shall explain the mechanism to remove a clot from the analyzer and if it is performed automatically. – necessary for this testing or would we know from the graph/results?

2.5.21 The analyzer shall immediately alert the operator that a sample is not positioned properly or if there is insufficient sample quantity, The Contractor shall explain the mechanism to detect insufficient blood volume for testing or a short sample. The Contractor is to explain how short samples are analyzed on the proposed analyzer.

2.5.22 If QC is required, the viscoelastic testing system shall be capable of being programmed to perform and execute auto quality control without operator intervention, detecting and flagging out of range quality control, perform automatic corrective action (i.e. rerun QC) if the QC is unacceptable, and have the ability to lock out/suppress a test if there is a QC failure.

2.6 TECHNICAL FEATURES: The instrumentation and parameters for whole blood analysis must be approved by the Food and Drug Administration (FDA) and have the following:

2.6.1 If QC is required, the system shall have a comprehensive on-board QC data management system with a minimum storage capacity of 90 days of QC files and includes Levy-Jennings graphs.

2.6.1.1 The analyzer must have the ability to capture, store and automatically electronically transfer QC data.

2.6.1.2 Ability to edit or correct errors in QC files manually with or without password protection.

2.6.1.3 Ability to have on-board documentation for out-of-range QC and instrumentation problems.

2.6.1.4 Ability to view and print daily and/or monthly QC results and Levy-Jennings graphs.

2.6.1.5 Ability to visually alert the operator of QC (Westgard and user defined rules) failures.

2.6.1.6 Ability to electronically transfer QC without any additional cost to the Contractor’s peer program without the need for manual entry or to download data to a disc.

2.6.2 The system shall have a design that removes the possibility of sample carryover. The Contractor shall provide documented evidence confirming the system design removes the possibility of any sample carryover.

2.6.3 The viscoelastic testing system shall have on-board maintenance records that can be modified for additional user defined maintenance tasks and printed at selected time intervals for maintenance documentation. The vendor shall describe their method for documenting maintenance activities.

2.7 HARDWARE FEATURES

2.7.1 The Contractor shall list the utility requirements for the proposed equipment (i.e. electrical, plumbing, reagent and/or waste biohazardous disposal, water, etc.).

2.7.2 The instrumentation shall have an on-board monitor/screen that is easily readable in addition to built-in speakers, a keyboard, and mouse. The analyzer shall have a touch-screen interface.

2.7.3 The instrumentation shall have the capability of printing a patient report with patient demographic information that includes minimally the patient’s name, social security number, order number/accession or unique identifier number (UID), test performed, and the phlebotomy site. The Contractor shall provide a replacement printer as needed. The Contractor shall list programmable options for the patient demographic report.

2.7.4 The instrumentation shall have an uninterruptible power supply (UPS) with line conditioner for each instrument provided. Each UPS shall provide electrical power after electrical power fails. The Contractor shall state how long the UPS will provide back-up for each piece of equipment. The Contractor shall be responsible for replacing the UPS, should it become dysfunctional and provide battery replacement as needed.

2.7.5 The Contractor shall list any routine or special items that are required to operate or maintain the proposed equipment in optimal condition. Any items excluded by the Contractor shall be delineated in their proposal. The cost of the excluded items shall be incorporated in the price proposal.

2.8 INSTRUMENTATION AND SOFTWARE

2.8.1 The viscoelastic testing system shall have the ability to manage patient information through a data management system that electronically links to the testing instrumentation. The data manager shall allow users to monitor and analyze data. The vendor shall describe the following capabilities of their proposed data management system:

2.8.1.1 Acceptance of test ordering information, transmittal of patient laboratory results, storage, and retrieval of patient laboratory results.

2.8.1.2 User defined/set-up decision rules for analyzer flags, linearity, delta checks, and critical values and proactive alerting system (i.e. visual and audible) for alerts, unusual or pending test results.

2.8.1.3 Ability to monitor and track users to included competency records.

2.8.2 The Contractor shall assist each facility throughout the life of the contract with optimizing operation and utilization of the data management support software (to include building rules) to enhance productivity and the management of workflow.

2.8.3 The Contractor shall provide, support, maintain, and upgrade the antivirus software, and any Microsoft security updates for the duration of the contract to the data manager and analyzer(s).

2.8.4 The viscoelastic testing system may have the ability to auto-verify results.

2.9 INTERFACE REQUIREMENTS

2.9.1 The Contractor is to complete with their quote the Medical Equipment Pre-procurement Assessment (VA Directive 6550 Appendix A) for the Office of Information Technology (OI & T) for the facility for any medical devices that will be connected to the VA information network. The vendor will provide evidence of VA approved remote network communication system that continuously collects and monitors performance data of the analytical systems following all the policies and procedures outlined in the VA Directive 6500, Information Security Program, and its handbooks to ensure appropriate security controls are in place (see Appendix A in Section D).

2.9.2 The viscoelastic testing system shall be able to directly interface with at least one of the current VA laboratory middleware systems currently in use at Richmond VAMC (GEMWeb plus or Unipoc). The Contractor shall provide documentation of successful interfacing with other VA facilities.

2.9.3 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.

2.9.4 The Contractor shall provide any and 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.

2.9.5 If the 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.

2.9.6 If the 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. Routing must be fully supported by all laboratory instrument interface partners, especially Data Innovations, Inc. and Cerner.

2.9.7 The interface may use automatic host query to download sample IDs, test requests and patient demographics, i.e. bi-directional. If automatic host query is used it must seamlessly integrate with the patient sample barcode scanning and translation. The vendor shall describe the host query and interface capabilities.

2.9.8 Instrument interface must transmit test results to the host computer system via automatic upload.

2.9.9 Should there be any software upgrades to the instrument(s) during their life, the Contractor shall be responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system.

2.9.10 The Contractor will always maintain compatibility of systems with whatever host Laboratory Information System is in place, especially when the Contractor’s software is upgraded.

2.9.11 The viscoelastic testing system shall have an automatic back-up function to store all data from the hard drive.

2.10 SUPPORT FEATURES

2.10.1 Commercial marketing. The equipment models being offered 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.

2.10.2 Start-Up Reagents/Installation. The Contractor shall supply all cross-over supplies for the training of staff on-site and for the installation of the equipment to meet all regulatory guidelines.

2.10.3 At installation of new equipment, the Contractor shall provide the physical installation of the equipment. Installation shall include, at a minimum, uncrating and/or unpacking of all equipment, hardware setup and hook-up of the system, removal of trash, and documentation that the analyzer(s) is functioning within the correct specifications.

2.10.4 The Contractor shall provide a preventative maintenance schedule for all of the proposed equipment for the duration of the contract. The Contractor shall state their preventative maintenance schedule.

2.10.5 The Contractor shall provide emergency equipment repair and preventative maintenance on the data manager, all primary and back-up instrumentation, and any incremental support equipment offered.

2.10.6 A technical assistance center shall be available by telephone 24 hours per day, 7 days per week. The Contractor shall provide technical support services at no additional charge to the facility.

2.10.7 Service shall include, at no charge, all labor, travel, and all replacement parts necessary to make repairs. The Contractor shall provide all replacement parts at no charge and any components necessary for the operation of the equipment to produce patient results.

2.10.8 The Contractor shall provide instrument support service sufficient to aid with troubleshooting and repair of the analyzer(s). The Contractor shall list their available service options.

2.10.9 The Contractor shall state what the cut-off time is for same-day service if there is an equipment failure that requires repair. The Contractor shall state: What is the latest time that an FSR will be dispatched for a service call that is received on the same day.

2.10.10 Technical support shall place a service call for repairs if the technologist is unable to repair the analyzer The vendor shall describe their response time on weekends/ holidays/ irregular tours.

2.10.11 The Contractor shall send a service/repair notification (with confirmation number) to the facility which shall include the estimated time of arrival when a call for service or repair is requested.

2.10.12 A service/ incident report shall be furnished to the laboratory upon completion of each repair or service call. The report shall include, as a minimum, the following:

· Date and time notified.

· Date and time of arrival.

· Serial number, type and model number of equipment

· Time spent for repair, and

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

2.10.13 The Contractor shall pay all routine shipping fees for supplies, consumables, and equipment to perform testing at initial installation and with routine supply delivery.

2.10.14 The Contractor shall state how many analyzers they have placed in the U.S. and the national average of service calls per analyzer.

2.10.15 Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software 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 and installed as they become commercially available at each site within two months of the issuance or date of first commercial availability. This requirement only applies to “system upgrades” that enhance the model of 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 Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the contract; however, it does refer to significant changes in the hardware operational capability.

2.11 METHOD PERFORMANCE/VALIDATION REQUIRMENTS

2.11.1 At installation/set-up the Contractor/technical support specialist shall perform all validation studies including: installation/set-up, correlation studies (evaluation/comparison data sufficient to satisfy regulatory standards), reference range studies, staff training, in-service to laboratory personnel and clinicians, and assist with any methodology problems and/or questions. The service must be available during regular office hours on a 5 day/week basis.

2.11.2 Method performance/comparison shall be at the expense of the Contractor, shall include linearity material and reagents, and be consistent with current CLSI guidelines and related documents, regulatory requirement, and Federal regulations.

2.11.3 Correlation studies for each parameter. A minimum of 40 samples or whatever the individual facility may require for each sample type spanning the reportable range, shall be run by the present and the proposed method. The 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, Receiver Operating Characteristic (ROC) analysis, and meet current standards defined by CLSI.

2.11.4 Analytical Measurement Range (AMR) validation shall be performed on proposed instrument(s) for each parameter 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 range shall be performed as a minimum.

2.11.5 Precision Study - 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.

2.11.6 Sensitivity - Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rate, and false negative rate are applied.

2.11.7 Specificity Studies - A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, lipemia, hematocrit, white blood count (WBC), different anticoagulants, or other interfering substances.

2.11.8 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.

2.11.9 Stability Studies - The Contractor shall provide manufacturer verified documentation of sample stability or perform the required studies. The Contractor shall state which parameters should or should not be placed on ice prior to testing.

2.11.10 Reference Range - 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. One of the following protocols shall be used:

· 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.

· 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.

· 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.

2.11.11 Reports - The Contractor shall supply accurate data for annual contract renewal by the required time frames, ensure timeliness of billing reconciliations, and can use the appropriate billing method required by the VA. Additional invoice charges associated with reagent and/or supply wastage or repair parts included at no charge shall not be accepted.

2.12 TRAINING:

2.12.1 The Contractor shall provide an on-site instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services. Basic operator training shall be provided by the Contractor on-site for all operators on all shifts. Training shall include basic operation, quality control, interpretation of results, reporting of results, required user performed maintenance, and troubleshooting. The Contractor or Application Specialist shall provide a documented record of training (training checklist) completed for all trained staff before leaving site following installation at the facility.

2.12.2. The Contractor may provide an in-depth off-site training. The vendor shall describe the off-site training program, the number of users and frequency. 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.

2.12.3 The Contractor may provide on-site refresher instrument training, wet workshops, advanced troubleshooting or any appropriate training in renewal option years of the contract if so, exercised at no cost to the facility.

2.12.4 The Contractor shall supply all necessary procedure manuals, troubleshooting manuals, operator manuals, and Safety Data Sheets (SDS) on a CD or on-line. The procedures shall be in Clinical Laboratory Standards Institute (CLSI) format. The Contractor shall provide assistance in creating preventative maintenance, quality control and/or logs to meet the needs of each facility.

2.13 IMPLEMENTATION/TRANSITION TIMEFRAME

2.13.1 The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after award. This timeline is based on a reasonable attempt of the Contractor to complete all the necessary implementation requirements within the stated timeframe. The Contractor shall not be penalized for implementation timelines that extend beyond the 90-day timeframe if the extension is through no fault of the Contractor and is a result of delays due to the Government.

2.13.2 Upon award, the transition period for all equipment and peripherals installed and operational shall be from date of award through 90 days. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

2.13.3 The Contractor shall provide with its quotation an implementation plan for installation of new equipment. The Contractor’s submitted plan shall not exceed 90 days for the transition of all services under the award 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 for cause under the Termination for Cause clause.

2.13.4 At the end of 90 days from award, the awarded Contractor shall have full and sole responsibility for services under the awarded contract.

2.14 CHARACTERIZATION OF WASTE

2.14.1 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.

2.14.2 The determination and description shall address the following:

· Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

· Waste ignitability (Reference 40 CFR §261.21)

· Waste corrosivity (Reference 40 CFR §261.22)

· Waste reactivity (Reference 40 CFR §261.23)

· Hazardous waste from non-specific sources (F-listed) (Reference40 CFR §261.31)

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

·…