S02 36C26125Q0065.docx

36C26125Q0065

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

36C261-24-AP-2396

36C26125Q0065 11-04-2024 Tawnya Krommenhoek tawnya.krommenhoek@va.gov 12-02-2024

12PM

PST

36C261 Department of Veterans Affairs Network Contracting Office 21 VA Southern Nevada Healthcare System 6900 N. Pecos Road, Building 6 North Las Vegas NV 89086 X 334516 1000 Employees N/A X See Delivery Schedule

36C261 Department of Veterans Affairs Network Contracting Office 21 Southern Nevada Healthcare System 6900 N. Pecos Road, Building 6 North Las Vegas NV 89086

Department of Veterans Affairs Financial Services Center P.O. Box 149971 Austin TX 78714-9971 See CONTINUATION Page VA Central California Health Care System (VACCHCS) Contractor shall provide Chemistry & Immunoassay Equipment and Testing on a Cost Per Reportable Result (CPRR) basis in accordance with the Statement of Work and Price List.

Estimated Period of Performance:

Ordering Period 1: April 1, 2025 – September 30, 2025 Ordering Period 2: October 1, 2025 – September 30, 2026 Ordering Period 3: October 1, 2026 – September 30, 2027 Ordering Period 4: October 1, 2027 – September 30, 2028 Ordering Period 5: October 1, 2028 – September 30, 2029 Questions regarding this RFQ are due by 12PM PDT on November 15, 2024.

Contracting POCs:

David J. Alvarez, david.alvarez4@va.gov Tawnya Krommenhoek, tawnya.krommenhoek@va.gov See CONTINUATION Page X X David J. Alvarez

VA-VHA-RPOW-2023-0048

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 36C261 David J. Alvarez Department of Veterans Affairs Network Contracting Office 21 VA Southern Nevada Healthcare System 6900 N. Pecos Road, Building 6 North Las Vegas NV 89086

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.

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

All invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests. 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 register and begin submitting electronic invoices, free of charge. The Department of Veterans Affairs Tungsten Number is: AAA544240062 (this allows you to file invoices online for free.)

More information on the VA Financial Services Center is available at:

http://www.fsc.va.gov/einvoice.asp.

Vendor e-Invoice Set-Up Information:

If you have questions 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 PRICE/COST SCHEDULE

The Contractor shall furnish a Cost per Reportable Result (CPRR), Clinical Laboratory Analyzer for Chemistry and Immunoassay Testing for the Department of Veterans Affairs in accordance with the specifications listed herein.

The guaranteed minimum award amount for this contract is $100.00. The maximum aggregate value of orders that can be placed under this contract is $2,000,000.00. The Government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum award amount. Quantities provided are estimates only and will be used for price evaluation.

ITEM INFORMATION

Ordering Period ONE (1) - Chemistry and Immunoassay Cost per Reportable Result (CPRR) Equipment and Testing.

Please see attached Price List for applicable Ordering Period.

Contract Period: Ordering Period ONE (1) POP Begin: 04-01-2025 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): N/A

Ordering Period TWO (2) - Chemistry and Immunoassay Cost per Reportable Result (CPRR) Equipment and Testing.

Contract Period: Ordering Period TWO (2) POP Begin: 10-01-2025 POP End: 09-30-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Ordering Period THREE (3) - Chemistry and Immunoassay Cost per Reportable Result (CPRR) Equipment and Testing.

Contract Period: Ordering Period THREE (3) POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Ordering Period FOUR (4) - Chemistry and Immunoassay Cost per Reportable Result (CPRR) Equipment and Testing.

Contract Period: Ordering Period FOUR (4) POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Ordering Period FIVE (5) - Chemistry and Immunoassay Cost per Reportable Result (CPRR) Equipment and Testing.

Contract Period: Ordering Period FIVE (5) POP Begin: 10-01-2028 POP End: 09-30-2029 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

B.3 DELIVERY SCHEDULE

2615 E. Clinton Ave.

Fresno, CA 93703

USA

2615 E. Clinton Ave.

Fresno, CA 93703

USA

2615 E. Clinton Ave.

Fresno, CA 93703

USA

2615 E. Clinton Ave.

Fresno, CA 93703

USA

2615 E. Clinton Ave.

Fresno, CA 93703

USA

B.4 STATEMENT OF WORK

Statement of Work (SOW)

1. INTRODUCTION

VA CENTRAL CALIFORNIA HEALTH CARE SYSTEM has a requirement for a Cost Per Reportable Results (CPRR) Indefinite Delivery, Indefinite Quantity (IDIQ) contract for clinical laboratory and immunoassay analyzers. The contractor agrees to provide a price schedule with Cost Per Reportable Results (CPRR) Pricing structures only, in accordance with the terms and conditions of the SOW to the Veterans Integrated Service Network 21 (VISN 21), identified as the Government herein. The services and prices are specified in the sections entitled Schedule of Supplies/Services of this contract.

Period of Performance: 5-year ordering period with five one-year pricing periods.

The proposed period of performance is:

Place of Performance: The scope of this contract covers the entire area of responsibility (AOR) of VA CENTRAL CALIFORNIA HEALTH CARE SYSTEM, including any clinic. The Government may add onto this IDIQ for any Community-Based Outpatient Clinic (CBOCs), clinics, etc.

1.1 Participating Facilities: Points of contact per facility are listed below.

STATION 570 VA CENTRAL CA HEALTHCARE SYSTEM

VA Central CA Healthcare System 2615 E. Clinton Ave Fresno, CA 93703 Point of contact:__________________________________

1.2 VA CENTRAL CALIFORNIA HEALTH CARE SYSTEM has provided estimated volumes of tests performed in the attached Price List (S02 36C26125Q0065 Price List) for each individual medical center and outpatient clinic laboratory. The Government estimates the volumes listed in the attached spreadsheet per facility but does not guarantee volumes as listed. Volumes may fluctuate up or down during the term of the IDIQ.

Types of Analyzers at each location:

STATION 570 VA CENTRAL CA HEALTHCARE SYSTEM

2. Required Specifications

2.1 General

· The desired instrumentation will have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrumentation will be able to perform the profile as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (Hereafter referenced as CLIA) and the Clinical and Laboratory Standards Institute (Hereafter referenced as CLSI). Equipment will be new, state of the art, and not recertified nor refurbished. Equipment will be acquired for each of the clinical laboratories located at VA CENTRAL CALIFORNIA HEALTH CARE SYSTEM.

· 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 will be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Unexpected changes in methodology/technology will 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 local Point of Contact (Hereafter referenced as POC). These individuals will be identified upon award of the delivery order/s.

· 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 will 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 will be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

· Industry Standards – Unless otherwise stated, all equipment will be held to current industry standards for such equipment as present within the current market for Chemistry, Immunoassay, and automation equipment, supplies and services.

· Only instruments which are FDA approved will be considered. Instruments will be operational and must interface with VA Laboratory Computer systems and upgrades.

· Test methods will be FDA approved.

2.2 Definitions

Cost-Per-Reportable-Result (CPRR) – Contractors are required to provide a price for a reportable patient result. The cost per reportable result price will include costs covering (a) equipment use, (b) all reagents, standards, 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 does not include those items approved for exclusion by the government such as printer paper, labels etc. This per patient reportable result price will also encompass all costs associated with dilution, repeat and confirmatory testing required to produce a single patient reportable result. It will 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 National Committee for Clinical Laboratory Standards (NCCLS). (c) All necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs and (d) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge.

Clinical Laboratory Chemistry Analyzer - Automated system for the robotic specimen handling and accurate analysis, data review, and reporting of human chemistry testing.

Clinical Laboratory Immunoassay Analyzer – Automated system for the robotic specimen handling and accurate analysis, data review, and reporting of human immunoassay testing.

Primary analyzer(s) – Base equipment offered that will 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), likewise, be considered primary instrumentation, and will be compatible with the primary analyzer, and meet the technical specifications of this solicitation. Those additional analyzer(s) offered meeting the definition of a primary analyzer will be equivalent to a back-up analyzer (see definition below) and replace the requirement for offering that category of equipment.

Back-up analyzer(s) – Equipment required to support the operations of the NCO laboratories when the primary analyzer(s) is not operational/functional. However, this equipment may also be used in conjunction with the Primary Analyzer to meet NCO program requirements as determined by the NCO, such as but not limited to “the simultaneous operation of both instruments to run additional testing as needed to meet program requirements.” This category of equipment must be capable of operation during periods of time when the primary instrumentation is not available for use. The back-up analyzers will be of the same model as the Primary Analyzers to allow the facility to continue operation at appropriate levels.

Business Associate Agreement (Hereafter referenced as BAA) -¬ A business associate is an entity, including an individual, company, or organization that, on behalf of the VHA facility, 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 everyone 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.

Community Based Outpatient Clinic (Hereafter referenced as CBOC) – CBOC’s are smaller facilities with smaller throughput than their larger parent facilities. Specific CBOC laboratories with test volumes listed in Attachment A – Volume Estimates and Individual Test Pricing will require equipment placements.

2.3 Chemistry Instrumentation:

The instrumentation capabilities:

a) Using third-party analyzer(s) to meet test menu requirements is not acceptable.

b) Using third-party equipment for automation is acceptable.

c) Third party open channel assay on contractors’ solution is acceptable.

a) Relocated equipment within the laboratory space must stay within the same room.

b) “Affixed equipment” means equipment affixed or anchored to real property or requiring dismantlement for relocation.

11. Perform the creatinine, hemoglobin A1C and cholesterol assay testing using a method referenced to an international standard (e.g., WHO standard). If the methodology changes and warrants patient re-baselining, the Contractor to provide necessary services and materials.

27. Equipment provide(s) an Uninterruptible Power Supply (UPS). If possible, provide a single UPS with the capacity to maintain continuous operations for 30 minutes allowing for a controlled shutdown or to shut-down the instrument in an orderly manner in the event power outage.

28. The contractor has the capability to establish a remote connection for the purpose of instrument troubleshooting, software updates, and delivering test volumes for invoice generation.

29. Calibration frequency not to exceed once per 24 hours per instrument for ISE.

30. Ability for long calibration stability for all other testing.

31. Ability to pre-calibrate new lots of reagents prior to use.

32. Quality control testing requirement frequency not to exceed once per 24 hours per instrument.

33. Ability to lock out/suppress test analytes if there are QC failures.

34. No requirements for sample pre-treatment.

35. Test volumes are listed by facility in Attachment A – Volume Estimates and Individual Test

2.4 Immunoassay Instrumentation

The instrumentation capabilities:

1 Provide immunoassay analyzers with consistent methodology for load balancing (workload) and back up purposes as indicated in the equipment list. Secondary or backup analyzer(s) specified to be manufactured by the same Contractor receiving the award and use(s) the same reagents for each test to allow for standardized test builds.

a) Third-party analyzer(s) to meet test menu requirements is not acceptable.

b) Using third-party equipment for automation is acceptable.

c) Third party open channel assay on contractors’ solution is acceptable.

21 Provide solutions for STAT turnaround time on Immunoassay testing.

22 Immunoassay incubation times not to exceed 30 minutes, to meet or exceed current turnaround times.

23 A Troponin which meets the IFCC definition of high sensitivity i.e., can be detected in at least 50% of normal reference population.

24 State carryover claim and design solutions to mitigate carryover.

2.6 Automation for Chemistry and Immunoassay:

1. Relocated equipment within the laboratory space must stay within the same room.

1. “Affixed equipment” means equipment affixed or anchored to real property or requiring dismantlement for relocation.

10. Automation includes input sorting technology (such as a hopper) and the ability to aliquot.

11. Has the capability to establish a remote connection for the purpose of instrument troubleshooting, software updates, and delivering test volumes for invoice generation.

12 Ability to make bar code labeled aliquot tubes that mirror the primary tube labeling for offline processing.

13. De-capper has/have the ability to remove different cap types (e.g., hemogard, screw caps, rubber stoppers). This is necessary to maintain employee safety by reducing the exposure to body fluids and maintain workflow and turnaround time.

14. Uncapping and recapping/sealer system in an enclosed environment to prevent distribution of bio- hazardous aerosols.

2.7 Data Management for Chemistry and Immunoassay:

11. Listed as preferred but not required: Will automatically calculate and report to the LIS both Free and BioAvailable Testosterone, using values from Total Testosterone, Albumin, and Sex Binding Globulin Hormone.

12. Has/have the capability to transmit QC data to an external real-time QC service.

2.8 Software for Chemistry and Immunoassay:

3. Installation/Site Preparation:

1. Site preparation specifications for each facility to be furnished in writing by the Contractor as a Site Preparation Report after award of the delivery order/s. The report to be provided to the Contracting Officer no later than one week after award of the delivery order/s and all other site reports to be provided at least forty-five (45) days before installation.

All proposed equipment should fit in the available lab space square footage with proper egress for safety.

a) Relocated equipment within the laboratory space must stay within the same room.

b) “Affixed equipment” means equipment affixed or anchored to real property or requiring dismantlement for relocation.

4. Service and Maintenance

1. Contractor provides equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support equipment, e.g., water system, covered under the delivery order/s award, and UPS.

2. Support Services: Contractor provides telephone assistance 24-hours/day, 365 days per year with a call back response of 2 hours. Following determination that service is required, technical on–site support provided under the terms of the contract and provided for emergency repairs 365 days per year within twenty-four (24) hours of the time of notification of the malfunction for medical center labs. For CBOC labs, during normal operating hours, within twenty-four (24) hours of the time of notification of the malfunction. If both primary and backup analyzers are not able to perform a test listed as STAT, Contractor has/have defined, approved contingency plan(s) to ensure continuation of testing. Contractor provides maintenance (labor and parts) to keep the equipment in good operating condition and subject to security regulations. The government will provide the Contractor access to the equipment to perform maintenance service according to the maintenance and service terms.

3. Contractor to furnish a malfunction incident report to the installation upon completion of each repair call. The report includes, at a minimum, the following: (a) date and time notified; (b) date and time of arrival; (c) serial number, type and model number(s) of equipment; (d) time spent for repair; (e) description of malfunction and repair; and (f) proof of repair that includes documentation of quality control being performed and within range, as applicable. Notify the site management if repair is significant enough to require calibration and/or validation following the repair and Contractor performs calibration and/or validation.

4. Maintenance plan: Contractor provides manufacturer’s daily, weekly, monthly, quarterly and periodic maintenance plan, outlining time required for hands on and automated tasks.

5. Daily maintenance: Instrumentation requires minimal hands-on daily maintenance.

6. Preventative Maintenance: Contractor provides regular, scheduled maintenance coordinated with the site management to assure the continued reliable operation of the equipment. These preventive maintenance visits are of a frequency that conforms to the manufacturer's operation and maintenance instructions for the supported equipment.

7. Emergency Repair: Emergency repairs performed after notification that the equipment is inoperative. Contractor provides the government with a designated point of contact and shall make arrangements to enable its maintenance representative to receive such notification. Contractor performs emergency repair service within 24 hours of time of notification of the malfunction. Contractor provides all parts and labor needed to repair the malfunction. Travel, per diem and other expenses associated with the repair shall be borne by the Contractor. Contractor furnishes a malfunction incident report to the installation upon completion of each maintenance call. The report includes, at a minimum, the following: (a) date and time of arrival. (b) Serial number type and model numbers(s) of equipment (c) time spent for repair, (d) description of malfunction and (e) proof of repair.

8. Maintenance Support: Service repair person locally based within the geographical area.

9. Maintenance Credit for Equipment Malfunction: If a machine remains inoperative due to a malfunction through no fault or negligence of the government for more than 24 hours, the Contractor is assessed damages at the rate of 1/30 of the preceding average three-month CPRR billings times the total number of days certified as downtime. Each incident starts from the time the user makes a bona fide attempt to contact the Contractor's designated representative at the prearranged contact point until the machine is returned to good operating order less any non-contracted maintenance (emergency repairs) days.

10. Replacement of Laboratory Equipment: During the contract period, should the repair record of any laboratory equipment reflect a downtime of 10% or more of the normal working days in one calendar month, a determination will be made by the representative of the government to replace the initial laboratory equipment with new equipment. The responsibility of maintaining the equipment furnished in good condition shall be solely that of the Contractor.

11. Failure Mean Time Disclosure: Contractor states the failure mean time (between failure and mean time to repair) for each piece of equipment offered. Contractor to provide redundant systems to eliminate need of emergency backup equipment.

12. Upgrades or Replacement: Request for instrumentation upgrades or replacement, due to workload increase, menu changes, technological upgrades, excessive instrumentation failures/malfunctions, breakdowns, or service calls will be evaluated as needed/annually with communication to the Contractor for modification of the contract. A high incidence of problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility/clinic to its replacement with another analyzer(s) that can produce the required criteria of this contract satisfactorily to the user. Removal of instrument by the Contractor performed within 60 days after request.

5. Training

1. Contractor provides 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 this contract. This includes training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, Contractor provides training at a minimum for one operator per installed analyzer per year for the duration of the contract at the discretion of the Government for each model of instrumentation or automation placed. Utilization of the training slots will be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel includes the cost of airfare, room, and board for each participant.

2. Onsite Training: During the validation process of the installation, the Contractor provides technical resources to train operators on all shifts of operation. This can be accomplished by holding training sessions for multiple employees on each shift.

3. Additional training required:

(1) Advanced training, either off-site or in-house, provided on instrument troubleshooting, advanced middleware rules writing, data analytics, report writing and customization

(2) On-site refresher training in renewal option years of the contract made available annually for the duration of the contract.

4. Contractor provides supplemental on-site operator training to government personnel, without additional charge to the government, upon installation of upgraded equipment hardware or operating system software connected with the operation of an instrument that has already been installed.

6. Upgrade/Updates Contractor provides updates 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. Upgrades are 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 updates” that enhance the model of equipment being offered, i.e., new version of software, correction of hardware defect, update 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 delivery order/s; however, it does refer to significant changes in the hardware operational capability. Should any facility decide to upgrade their current equipment, i.e., replace existing equipment with newer models, the CO and Contractor may do so under a signed supplemental agreement.

7. Information Technology

· A VA Directive 6550 – Appendix A completed for each analyzer offered under the solicitation.

· Primary and back-up instrument interfacing is required at all sites. The current type of interface system is Data Innovations.

· Contractor is responsible for providing all hardware and software licenses required for the connection, and implementation of the analyzer’s interface to the Laboratory’s Universal Interface.

· Contractor provides 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.

· Contractor provides any additional support material that is routinely provided to equivalent commercial customers and shall assist in regulatory compliance, e.g., electronic procedure manual

· Contractor has/have the capability to establish a remote connection for the purpose of instrument troubleshooting, reagent management, software updates, and delivering test volumes for invoice generation. Has/have an ISA/MOU is established with the VA OI&T (Office of Information and Technology) to allow for the implementation of remote diagnostics connectivity. All connectivity hardware and installation is provided by the Contractor.

8. Ancillary Support Equipment

1. Contractor provides, installs, and maintains, as indicated, any and all ancillary support equipment to fully operate the analyzer or automation as defined in these specifications, e.g., cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), compressed air, and universal interface equipment, UPS, etc. Contractor includes all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g., starter kits, tables/stands, etc.

9. Packaging and Marking

1. All supplies are adequately packaged to prevent damage during shipping, handling and storage. Bags or packages are whole, intact, and not otherwise torn or damaged. Contractor is required to replace unacceptable or damaged products at the Contractor’s expense.

2. Items are marked clearly with the delivery order number, purchase order number, and delivery location within the hospital i.e., Laboratory Services/113.

10. Installation/Implementation

1. PHASE-IN/PHASE OUT REQUIREMENTS - Due to the length of time required to implement the requirements.

2. Phase-in requirements: The implementation of the services/requirements described in this solicitation shall be completed no later than 180 days or based on the mutually agreed upon timeline by the Contractor and VA after award. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractors shall not be penalized for implementation timelines that extend beyond the 180-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government (i.e., construction/ remodeling of facilities). Upon award, the transition period for the awarded Contractor to have all equipment and peripherals installed and operational shall be 120 days from the date of award through 180 days or based on the mutually agreed upon timeline by the Contractor and VA.