36C26122R0037.docx

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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

36C261-21-AP-2993

36C26122R0037 06-07-2022 Mandy Thompson 650-493-5000 x62211 07-06-2022 12:00

PDT

Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Palo Alto Health Care System (90/NCA) 3801 Miranda Ave Palo Alto CA 94304-1207 X 334516 1000 Employees N/A X ** See Statement of Work **

Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Palo Alto Health Care System (90/NCA) 3801 Miranda Ave Palo Alto CA 94304-1207

Department of Veterans Affairs FMS-VA-2(101) Financial Services Center PO Box 149971 Austin TX 78714-9971 See CONTINUATION Page VISN Chemistry & Immunoassay Analyzer CPRR ** See Statement of Work, Attachments A/B, and Price/Cost Schedule Section B2 for Solicitation Requirements. ** Period of Performance:

Date of award through seven (7) years There are seven one-year ordering periods.

See CONTINUATION Page X Mandy Thompson, Contracting Officer 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 Mandy Thompson Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Palo Alto Health Care System (90/NCA) 3801 Miranda Ave Palo Alto CA 94304-1207

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:

Statement of Work (SOW) June 2, 2022

1. INTRODUCTION

VISN 21 – VA Sierra Pacific Healthcare 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 that shall encompass 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: date of award through seven (7) years. There are seven one-year ordering periods.

Place of Performance: The scope of this contract covers the entire area of responsibility (AOR) of VISN 21, including any clinic. The Government will be free to add onto this IDIQ for any Community-Based Outpatient Clinic (CBOCs), clinics, etc. The addresses and locations may change, but the requirement applies to VISN 21.

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

STATION 459 PACIFIC ISLANDS

VA Pacific Islands Health Care System Department of Laboratory Service (113) 459 Patterson Road, Room 2-A03 Honolulu, Hawaii 96819 Point of contact: Jodi Liao - (808) 433-7619 - (Jodi.Liao@va.gov)

STATION 570 VA CENTRAL CA HEALTHCARE SYSTEM

VA Central CA Healthcare System 2615 E. Clinton Ave Fresno, CA 93703 Point of contact: William Walsh – (559) 225-6100 ext. 5719 – (William.Walsh5@va.gov)

STATION 612 NORTHERN CALIFORNIA HEALTH CARE SYSTEM

VA Sacramento Medical Center 10535 Hospital Way Mather, Ca 95655 Point of contact: Martha A Goodwin – (916) 843-7235 – (Martha.Goodwin@va.gov)

Martinez CBOC 150 Muir Road Martinez, CA 94553 Point of contact: Martha A Goodwin – (916) 843-7235 – (Martha.Goodwin@va.gov)

Redding CBOC 3455 Knighton Road Redding, CA 96002 Point of contact: Martha A Goodwin – (916) 843-7235 – (Martha.Goodwin@va.gov)

STATION 640 VA PALO ALTO HEALTHCARE SYSTEM

Chemistry B100-F4-160 VA Palo Alto HCS Building 50 Warehouse 3801 Miranda Ave, Palo Alto, CA 94304 POC: Lana Hur – (650) 493-5000 ext 66722 - (lana.hur@va.gov)

Livermore VA CBOC Building 65 Warehouse 4951 Arroyo Road Livermore, CA 94550 POC: Lana Hur – (650) 493-5000 ext 66722 - (lana.hur@va.gov)

STATION 654 VA SIERRA NEVADA HEALTH CARE SYSTEM

VA Sierra Nevada Health Care System 975 Kirman Avenue Reno, NV 89502 Point of contact: Tamara Mosley – (775) 784-3948 – (Tamara.Mosley@va.gov)

STATION 662 VA SAN FRANCISCO

VA Medical Center 4150 Clement Street San Francisco, CA 94121 Point of contact: Kristopher Taylor – (415) 750-2276 – (kristopher.taylor@va.gov)

Oakland CBOC 2221 Martin Luther King Way Oakland, CA 94612 Point of contact: Kristopher Taylor – (415) 750-2276 – (kristopher.taylor@va.gov)

STATION 593 VA SOUTHERN NEVADA HCS

1.2 NCO 21 has provided estimated volumes of tests performed in Attachment A – Volume Estimates and Individual Test Pricing 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 459 PACIFIC ISLANDS

STATION 570 VA CENTRAL CA HEALTHCARE SYSTEM

STATION 612 NORTHERN CALIFORNIA HEALTH CARE SYSTEM

STATION 640 VA PALO ALTO HEALTHCARE SYSTEM

STATION 654 VA SIERRA NEVADA HEALTH CARE SYSTEM

STATION 662 VA SAN FRANCISCO

STATION 593 VA SOUTHERN NEVADA HCS

2. Required Specifications

2.1 General

· The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument shall be able to perform the complete 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 shall be new, state of the art, and not recertified nor refurbished. Equipment shall be acquired for each of the clinical laboratories located at the following NCO 21 facilities: See Section 1.7.

· The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. 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 Contracting Officer Representatives (Hereafter referenced as COR). These individuals shall 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 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.

· Industry Standards – Unless otherwise stated, all equipment shall 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 shall be operational and must interface with VA Laboratory Computer systems and upgrades.

· Test methods shall be FDA approved. Vendors with limited recalls due to product failures are preferred.

2.2 Definitions

Cost-Per-Reportable-Result (CPRR) – Contractors are required to provide a price for a reportable patient result. The per reportable result price shall 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 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 be compatible with the primary analyzer, and shall meet all of 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.

Back-up analyzer – 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. As such, the requirements for consumable supplies, i.e. reagents, quality control material, calibrators, etc., shall be reasonably comparable and system performance shall be corollary to the successful operation of the primary instrumentation. The back-up analyzer shall be of the same volume and speed rating as the Primary Analyzer or a comparable alternative that will 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 offered shall provide the following capabilities:

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 vendor shall provide necessary services and materials.

27. Equipment shall be provided with 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. Long calibration stability preferred for all other testing.

31. Shall have the 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. Preference will be given to chemistry STAT test results that can be available within 15 minutes from the time it is loaded on the analyzer to the time results are available.

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

2.4 Immunoassay Instrumentation

The instrumentation offered shall provide the following capabilities:

1 Provide immunoassay analyzers with consistent methodology for load balancing (workload) and back up purposes as indicated in the equipment list. If a second or backup analyzer is specified on the attachment, the backup or secondary analyzer must be manufactured by the same vendor receiving the award and must use the same reagents for each test to allow for standardized test builds. Placing a third-party vendor’s analyzer to meet test menu requirements is not acceptable.

8 Analyzer and or data management system shall have Reagent and Control lot monitoring capabilities.

22. Provide solutions for STAT turnaround time on Immunoassay testing.

23. Prefer immunoassay incubation times not to exceed 30 minutes, to meet or exceed current turnaround times.

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

25. State carryover claim and design solutions to mitigate carryover.

2.6 Automation for Chemistry and Immunoassay:

10. Automation with input sorting technology (such as a hopper) and the ability to aliquot are preferred characteristics.

11. 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.

13. De-capper shall 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. Shall 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 shall be furnished in writing by the Contractor as a Site Preparation Report after award of the delivery order/s. The report shall be provided to the Contracting Officer no later than one week after award of the delivery order/s and all other site reports shall be provided at least forty-five (45) days before installation of all other sites. Contractor shall visit each site and propose the location of equipment and determine specific site prep requirements (before the bid) including but not limited to:

· Space availability

· Power availability

· Availability of waste drainage systems

· Increase heat load affecting air conditioning

· Specialized ventilation if required

· Special finishes required

· Carts for non-floor standing instrumentation

All proposed equipment must fit in the available lab space without construction modifications. Minimal construction may be considered if approved by the engineering department at the site. If site visit is not acceptable, bidding contractor will be provided with floor plans, requirements, measurements.

Mather: New laboratory will be renovated during the life of this contract and the initial installation of instrumentation will need to be moved to a temporary location, and then to a final location (and revalidated). All bids should include the costs for the moves for moving the equipment at Mather to a temporary location, and then to a final location.

4. Service and Maintenance

3. The contractor shall furnish a malfunction incident report to the installation upon completion of each repair call. The report shall include, as 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. Must notify the site management if repair is significant enough to require calibration and/or validation following the repair and vendor shall perform calibration and/or validation.

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

5. Daily maintenance: Instrumentation shall require minimal hands-on daily maintenance.

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

7. Emergency Repair: Emergency repairs shall be performed after notification that the equipment is inoperative. The Contractor shall provide the government with a designated point of contact and shall make arrangements to enable its maintenance representative to receive such notification. The Contractor shall perform emergency repair service within 24 hours of time of notification of the malfunction. The Contractor shall provide 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. The Contractor shall furnish a malfunction incident report to the installation upon completion of each maintenance call. The report shall include, as 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 shall be 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 shall start 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: The Contractor shall state 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 shall be performed within 60 days after request.

5. Training

1. 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 this 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 at a minimum for one operator per installed analyzer per year at the discretion of the Government for each model of instrumentation or automation 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. Onsite Training: During the validation process of the installation, the vendor shall provide 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. In addition to the training above the following shall be provided:

(1) Advanced training, either off-site or in-house, shall be 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 shall also be made available annually.

4. In addition, the Contractor shall provide 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

1. The Contractor shall provide 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. These upgrades shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system 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 shall be 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.

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

· The contractor shall 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. In order to accomplish this the contractor must 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 vendor.

8. Ancillary Support Equipment

1. The Contractor shall provide, install and maintain, 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. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g., starter kits, tables/stands, etc.

9. Packaging and Marking

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

2. All items shall be 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. Implementation/transition timeframe - 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. This requirement includes the implementation of autoverification and the transmission of QC data to an external real-time QC service. During this same period, all initial training of VA personnel in the operation and maintenance of said award shall also be completed with exceptions due to delays at the fault of the Government.

3. The new contractor/vendor must be able to coordinate with the laboratory and install the new equipment while the…