36C24223Q0312.docx

VA242-17-Q-0730

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

36C24223Q0312 Morgan Weeks 02-08-2023 3:00pm

EST

36C242 Department of Veterans Affairs Network Contracting Office 2 James J. Peters VA Medical Center 130 West Kingsbridge Road Bronx

NY

10468-3904 X 334516 1000 Employees N/A X See Delivery Schedule

36C242 Department of Veterans Affairs James J. Peters VA Medical Center Network Contracting Office 2 130 West Kingsbridge Road Bronx

NY

10468-3904

Tungsten Network https://www.tungsten-network.com/ customer-campaigns/veteransaffairs/

See CONTINUATION Page This solicitation is for an Indefinite Delivery, Indefinite DIQ) Contract for Urinalysis Chemistry and Automated Microscopic cost per test. This testing requirement is for Albany, Buffalo, Bath, Canandaigua, and Syracuse VA Medical Centers.

The awarded IDIQ Contract shall be for five years with the period of performance beginning on March 1, 2023.

See CONTINUATION Page X X X Morgan Weeks 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 36C242 Department of Veterans Affairs Network Contracting Office 2 James J. Peters VA Medical Center 130 West Kingsbridge Road Bronx NY 10468-3904

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:

36C24223Q0312

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1. Indefinite Delivery, Indefinite Quantity LANGUAGE

1.1. INTENT: It is the intent of the Department of Veterans Affairs, specifically the following Upstate New York Medical Center Laboratories: Albany, Buffalo, Bath, Canandaigua and Syracuse to establish an Indefinite Delivery, Indefinite Quantity, (IDIQ) Contract for Clinical Urinalysis to perform a cost per test. The requirement is for Urinalysis Chemistry and Automated Microscopic. The Government shall award a Contract to a single Contractor for Urinalysis Chemistry and Automated Microscopic cost per test and no subcontracting is authorized. The Contractor agrees to the following terms of the IDIQ exclusively with all three of the Upstate New York VA Medical Centers Laboratories and is responsible for executing 100% of the contract. Additional tests, reagents, and instrumentation may be added to the awarded Contract as new technology becomes available on the market to include continuing education to each of the three sites regarding new and upcoming tests as they become available at no additional cost to the Government.

1.2. ORDERS: The awarded Contract does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the Delivery Order and Purchase Orders by authorized individuals of the five Laboratory Medical Centers.

1.3. PRICES AND TERMS: The five Upstate New York VA Medical Centers will provide an estimated yearly volume for each of the two required tests. The following are the estimated yearly testing volumes: Albany Urinalysis Chemistry 21,278 tests a year and Manual Microscopic 7,557 tests a year. Buffalo Urinalysis Chemistry 30,581 tests a year and Manual Microscopic 15,378 tests a year. Syracuse Urinalysis Chemistry 31,289 tests a year and Manual Microscopic 8,903 tests a year. Bath Urinalysis Chemistry 4,852 tests a year and Manual Microscopic 1,359. Canandaigua Urinalysis Chemistry 6,708 test a year and Manual Microscopic 1,487 test a year. Pricing is based on cartridge price plus add on. Add on is figured by equipment at the facility divided by the average annual test volume, and includes service. This also includes calibrators and controls (where applicable) to be included in the cost per test pricing. Each of the five sites will be responsible for submitting their test counts each month to the awarded Contractor. The Government estimates the volumes as listed above, but does not guarantee volumes as listed; they are estimates only.

1.4. TERM OF AGREEMENT: This will be a single award, firm-fixed price five year IDIQ Contract. If the Contractor fails to perform in a manner satisfactory to the Contracting Officer, the awarded Contract may be canceled with thirty days written notice to the Contractor by the Contracting Officer. The Contractor shall also reserve the right to terminate the awarded Contract with thirty days written notice to the Contracting Officer. The awarded Contract shall be reviewed annually. The five Upstate New York VA Medical Centers Laboratories shall establish the first year of the Contract for the period from March 1, 2023 through April 29, 2024.

1.5. IDENTIFICATION: Delivery Orders issued shall be identified by the applicable Contract Number and the corresponding Purchase Order Numbers for the three VA Medical Centers Laboratories.

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

2. DESCRIPTION/SPECIFICATIONS

2.1. SCOPE OF PROCUREMENT:

2.1.1. The desired instrumentation shall have the capability of performing and reporting the clinical parameters as defined in this 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 (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

2.1.2. Equipment must maintain, or preferably reduce the number of work stations or overall labor required to accomplish the required testing.

2.1.3. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies,consumables 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. The expiration date must be clearly marked on all reagents, standards, and control containers. Unexpected changes in methodology and technology shall be at the expense of the Contractor. Notify of any delays in shipment as well as any or all technical advisory recalls and alerts, prior to or simultaneously with field alerts shall be forwarded to the Contracting Officer Representatives (COR’s) identified at contract award.

2.1.4. Special Handling for Emergency Orders of Supplies: In the event that 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 twenty-four 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 at no 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 or routine supplies delivery.

2.1.5. Data Management And Middleware Capabilities: The ability to provide Middleware that are able to provide services such as but not limited to: interface with laboratory computer system, advanced quality control that can be used to determine method precision and accuracy including Levy Jennings graphs, and storage of patient results with the ability to retransmit and print results in the event of an LIS problem or barcode read error. Each of the five sites requires its own Middleware Server.

2.2. DEFINITIONS:

2.2.1. Cost per Test (CPT) - as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Urinalysis Analyzers – The Contractor is required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering the following: (1) Five year equipment use. (2) All reagents, standards, quality controls, supplies, consumable and disposable items, parts, accessories, and any other items required for the proper operation of the Contractor’s equipment and necessary for the generation and reporting of a test result. (3) All necessary maintenance to keep the equipment fully operational. This includes both preventive maintenance and emergency repairs. (4) Training for Government personnel. (5) Contractor is required to provide delivery, installation, and removal of their equipment upon contract completion at no additional charge.

2.2.2. Parameter definitions-

2.2.2.1. A fully automated analysis system that is FDA approved and has been on the market for at least one year that is capable of Urinalysis Chemistry and Automated Microscopic Testing with current up to date digital imaging technology for urine sediment identification.

2.2.2.2. Contractor shall supply all instrumentation,UPS, reagents, supplies, and consumables to perform approximately 129,419 patient test results per year. Please note that this patient testing amount is the estimated total yearly number for all five sites combined.

2.2.2.3. Calibrators traceable to International Federation of Clinical Chemistry (IFCC). Ability to prioritize STAT testing without compromising existing programmed testing.

2.2.2.4. Minimum sample size shall be no more than 2ml.

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

2.4. GENERAL REQUIREMENTS:

2.4.1 Two Analyzers, One Primary and one Backup, and One Table for Each Site as needed. – If two different instruments are proposed for a site configuration, the reagent systems must be compatible.Base equipment offered that shall fully support the scope of operations while meeting all minimal requirements of operation. The table shall be of sufficient size that all Contractor equipment is able to be placed on the table.

2.4.2 Operational Features- The instrumentation offered shall have the following:

2.4.2.1 The capability of performing analysis on 100% of the tests listed in Attachment A.

2.4.2.2 Sufficient capacity and throughput to meet the volume and service demands as defined in Attachment A.

2.4.2.3 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 minimal and require a minimum amount of handling.

2.4.2.4 System must have a bi-directional bar coded computer interface compatible with Data Innovations. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system for all five sites simultaneously.

2.4.2.4.1The accuracy of the barcode reading must have less than a 1% failure rate.

2.4.2.4.2 Software with user defined parameters to assist with auto calibration or auto calibration alert multipoint calibration.

2.4.2.4.3 Computer connections and servers used for transferring data between the instrument and the VA’s data server shall be provided by the Contractor and be compatible with the VA’s data servers existing data ports.

2.4.2.4.4 Windows 10 compatibility and hardware and software functionality for direct network connectivity.

2.4.2.4.5 The ability to interface with the Vista System through Data Innovations bidirectionally.

2.4.2.4.6 Contractor responsible for any licensing or hardware used to connect to Data Innovations and the Network.

2.4.2.4.7 Any connections from the analyzer back to the Contractor shall follow the Department of Veterans Affairs guidelines and has to be FIPS 140-2 and CRISP compliant.

2.4.2.5 Daily maintenance shall require no more than ten minutes to complete.

2.4.2.6 Technologist intervention not required once samples have been loaded into the analyzer and the results have been printed.

2.4.2.7 Ability to store and retransmit records for twenty-four hours of maximal instrument throughput in case of interface outage.

2.4.2.8 Reagent stability sufficient to accommodate both high and low volume use. The Contractor shall provide expiration dates of at least one year for reagents. New lots of reagents and controls shall be supplied one month in advance to allow for complete cross over studies.

2.4.3 Technical Features- The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following Technical Features:

2.4.3.1 Internal and external Bar Code Reading.

2.4.3.2 Reagent inventory system with minimal reagent preparation.

2.4.3.3 Shall be available for detecting interfering substances with auto detection of adequate reagents and strips.

2.4.1.1. Good high end linearity for specific gravity, able to read urine color and clarity, and able to flag abnormal results. allow user to turn on/off abnormal result flags, and flexibility to set multiple units of measurement.

2.4.3.4 Auto-calibratiton or auto-calibration alert/multipoint calibration supported.

2.4.3.5 Shall have detector systems for bubbles, clots, and incomplete sample aspirations.

2.4.4 Hardware Features- The instrumentation shall have the following Hardware Features:

2.4.4.1 A total equipment footprint that when installed in the laboratories shall not impact the functionality and or operations of each laboratory.

2.4.4.2 Contractor to supply printer,cartridges/drums and replacement printers as part of their cost per test pricing.

2.4.4.3 Equipment must be able to support multiple barcode formats with a minimum of ten characters in the specimen identifier.

2.4.4.4 Ability to store and retransmit records in case of interface outage.

2.4.4.5 The flexibility to set multiple units of measurement.

2.4.6 Method Performance And Validation Requirements

Method performance and comparison will be at the expense of the Contractor and shall include the following: all reagents consumables and replacement parts, assayed quality control material, calibration material, and linearity material every six months. Linearity material and reagents, and results shall be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards, and Federal Regulations.

2.4.6.1 The Contractor shall perform method validation to include correlation study, crossover studies, sensitivity, linearity, reproducibility, and any additional test workup required to demonstrate satisfactory instrument performance consistent with CLSI Standards.

2.4.6.2 Carryover Studies. Successful carryover studies, demonstrating absence of any clinically significant carryover, shall be completed by the Contractor on the analyzers during installation. These studies shall be performed using either Contractor developed programs or programs developed by a third party (CAP/CLSI). The programs shall be provided to each laboratory at no charge.

2.4.7 Support Features-

2.4.7.1 Commercial marketing. The equipment models being offered shall be in current production as of the date the Contractor’s offer is submitted. For purposes of this Statement of Work, “current production” shall mean that the chemistry laboratory analyzer model being offered is new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. The Contractor shall perform to the satisifaction of the Government, as determined by the Laboratory Medical Director at each of the five sites, all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specifity as part of the cost per test pricing. The Contractor shall perform all of the statistical analysis as stated in the Method Performance And Validation section above and report data in an organized and clearly comprehensible format to the satisfaction of the Laboratory Medical Director at each of the five sites.Vendor support for connectios to the LIS and rules for Autoverification.

2.4.7.2 Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable and disposable items, parts, accessories, and any other item included on the list of supplies defined in the Federal Supply Schedule Contract and required to establish instruments for operation for performance of acceptance testing. The Contractor shall perform to the satisfaction of the Government, as determined by each of the three Laboratory Medical Directors all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity as part of the cost per test pricing. The Contractor shall perform all of the statistical analysis as stated in the Method Performance And Validation section above and report data in an organized and clearly comprehensible format to the satisfaction of each of the five Laboratory Medical Directors.

2.4.7.3 Training. The Contractor shall provide an instrument training program, to include two operators per instrument at vendor site. Training also should include provisions for additional training at vendor site or in house as appropriate for all shifts, that is coordinated with and timely to the equipment installation, sufficient to the size and scope of each of the five Sites services, and minimally equivalent to the terms and conditions for training defined in the Contractor’s Federal Supply Schedule FSC Group 66, Part III, Cost Per Test Clinical Urinalysis Analyzers Contract. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally two operators per Site per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the three Sites and the Contractor. A training program that involves off site travel shall include the cost of airfare and room and board for each participant.

2.4.7.4 Continuing education provided by vendor to sites regarding new and upcoming tests and technologies as they become available.

2.4.7.5 Equipment Preventative Maintenance And Repair Service. The Contractor shall provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation according to the following terms:

2.4.7.5.1 Service Requirements

2.4.7.5.1.1 Technical support by telephone available 24 hours a day 7 days a week. Onsite service Monday through Friday from 8:00 AM to 5:00 PM with emergency service provided within 24 hours.

2.4.7.5.1.2 A current contractor Service Agreement Plan will replace equipment and all moving parts and or any incremental networking or support equipment within one business day of complaint being received.

2.4.7.5.1.3 Preventive maintenance shall be performed by the Contractor at a minimum of every six months following the manufacturer’s operators manual as part of their cost per test pricing.

2.4.7.6 Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software, excluding analyzers and related accessories, in order to maintain the integrity of the system and the state of the art technology as part of their cost per test price. 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 upgrades that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrades offered to commercial customers at no additional charge, upgrades to replace a model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the awarded IDIQ; however, it does refer to significant changes in the hardware operational capability.

2.4.7.7 Ancillary Support Equipment - The Contractor shall provide, install, and maintain through the life of the awarded IDIQ, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, cabinetry to support and house the analyzers if necessary, water systems (including consumable polishers, filters, etc.), and universal interface equipment. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment they are proposing to include starter kits, tables and stands, etc.

2.4.7.8 Commercial Offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, to include a Computer Disc containing their procedure manual in CLSI format or an on-line procedure manual in the instrument software.

2.4.7.9 Characterization of Waste – 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.

2.4.7.9.1 The determination and description shall address the following:

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

2.4.7.9.1.2 Waste ignitability (Reference 40 CFR §261.21)

2.4.7.9.1.3 Waste corrosivity (Reference 40 CFR §261.22)

2.4.7.9.1.4 Waste reactivity (Reference 40 CFR §261.23)

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

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

2.4.7.9.1.7 Solid Waste (Reference 40 CFR §261.2)

2.4.7.9.1.8 Exclusions (Reference 40 CFR §261.4)

2.4.7.9.2 The Contractor will provide written instructions and training material to ensure all required VHA Laboratory Staffs are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the Contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

2.4.7.9.3 The Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum, the characteristics of ignitability, corrosiveness, reactivity and toxicity as defined in 40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerosal and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with vendor response:

2.4.7.9.3.14 pH

2.4.7.9.3.15 Flash point (to higher than 200F)

2.4.7.9.3.16 BOD; biochemical oxygen demand

2.4.7.9.4 The documentation the Contractor provides will be used to work with the VA Medical Centers to determine whether or not the waste from each device can legally be disposed of via the sewerage system.

2.4.7.9.5 The systems shall be totally self-contained excluding waste and shall not require external water, pressure, or vacuum. The Contractor shall provide a waste stream analysis for each proposed instrument and if any waste requires special handling before disposal.

2.4.7.10 Implementation And Transition Timeframe - The implementation of the requirements described in this Statement of Work shall be completed no later than ninety days after the the Contract award date. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. The Contractor shall not be penalized for implementation timelines that extend beyond the ninety day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

2.4.7.10.1 Upon award of the IDIQ, the transition period for the awarded IDIQ to have all equipment and peripherals installed and operational shall be from the date of award through ninety days. During this same period, all initial training of VA personnel in the operation and maintenance of said equipment shall also be completed. Training will include two operators per instrument at the Contractor’s location for all of the Laboratories shifts. Further, training shall include provisions for additional training at the Contractor’s location or at the respective Laboratory Facility as agreed upon by the Contractor and the respective Laboratory facility. During this same period all initial validations shall be completed to the satisfaction of each of the three Laboratory Directors.

2.4.7.10.2 The Contractor shall provide with their proposal an implementation plan for installation of their new equipment. The Contractor’s submitted plan shall not exceed ninety days for the transition of all services under the awarded IDIQ including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., and performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate the awarded IDIQ for cause under the Termination for Cause clause of the awarded IDIQ.

2.4.7.10.3 At the end of ninety days from the award of the IDIQ, the awarded Contractor shall have full and sole responsibility for services under the awarded IDIQ.

2.4.8 Standard and Quality of Performance- This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the awarded IDIQ is accepted by the Government. This also includes replacements, substitute machines, and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of thirty consecutive calendar days by operating in conformance with the Contractor’s technical specification or as specified in the awarded IDIQ at an effectiveness level of 90% or more.

2.4.8.1 In the event that the equipment does not meet the standard of performance during the initial thirty consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of thirty consecutive days.

2.4.8.2 If the equipment fails to meet the standard of performance after ninety calendar days from the installation date, the user or users may at their option request a replacement or terminate the awarded IDIQ in accordance with the provisions of FAR 52.212-4 entitled “Termination for Cause.” The Contractor shall receive payment for tests reported during the ninety day acceptance period.

2.4.8.3 Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition.

2.4.8.4 During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours.

2.4.8.5 The Government shall maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes.

2.4.8.6 During the term of the awarded IDIQ, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment.

2.4.9 Government’s Responsibility- The Laboratory Technologists shall perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The Laboratory Technologists shall maintain written records to satisfy the required maintenance requirements.

2.4.10 Ownership of Equipment- Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when it is returned to the Contractor. The Contractor upon expiration of the awarded IDIQ shall remove their equipment at no additional charge to the Government. The Contractor shall disconnect the analyzers (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzers from each of the three sites.

2.4.11 The Contractor will identify if removable media is required to perform their duties. The Clinical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device and system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from each of the three sites.

2.4.12 Prior to termination or completion of the awarded IDIQ the Contractor must not destroy information received from the VA, or gathered and created by the Contractor in the course of performing the awarded IDIQ without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within thirty days of termination or completion of the awarded IDIQ.

2.4.13 All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the awarded IDIQ or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the Contractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within thirty (30) days of termination or completion of the IDIQ or disposal or return of the IT equipment, whichever is earlier.

2.4.14 Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the Contractor at the end of lease, for trade-in, or other purposes. The options are:

2.4.14.1 Contractor must accept the system without the drive;

2.4.14.2 The VA’s initial medical device procurement includes a spare drive which must be installed in place of the original drive at time of turn-in; or

2.4.14.3 The VA must reimburse the company for media at a reasonable open market replacement cost at the time of purchase.

2.4.15 Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment and systems, if it is not possible for the respective VA Medical Centers to retain the hard drive then;

2.4.15.1 The equipment Contractor must have an existing Business Associate Agreement (BAA) if the device being traded in has protected health information stored on it and hard drives from the system are being returned physically intact; and

2.4.15.2 Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies, methods, and tools. Applicable media sanitization specifications need to be pre-approved and described in the awarded IDIQ.

2.4.15.3 A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The Information Security Officer (ISO) needs to maintain the documentation.

Baseline Configurations

Microsoft Windows Server The following versions are approved, with baseline compliance, for enterprise use:

· 2008 R2 (SP1)

· 2008 R2 (SP1) Core

· 2012

· 2012 Core

· 2012 R2 (Update)

· 2012 R2 (Update) Core Approved with Listed Constraints:

· 2008 x86 (non-core) is approved for SCCM 2007 infrastructure only. No new non-SCCM installations.

· 2003 is approved for existing installs only. No new installations without approved waiver.

· 2003 R2 is approved for existing installs only. No new installations without approved waiver.

Microsoft Windows Desktop and Laptop

· Windows 10

Microsoft Windows Medical Device Protection Program (MDPP)

· Windows 10

Macintosh Mac OS Workstation and Laptop

· Mac OS 10.10.X - Yosemite

· Mac OS 10.11.X - El Capitan

Linux

· Red Hat Enterprise Linux 6

Database Platforms SQL

· SQL Server 2012

· SQL Server 2014 Oracle

· Oracle 11g

· Oracle 11.2g

· Oracle 12c

Server Virtualization (Virtual Machines) With full virtualization the hypervisor is installed directly onto server hardware. Full virtualization has no underlying Operating System (OS). In Host-based virtualization the hypervisor is installed on the host OS. Moving forward, host-based virtualization is not authorized in VA.

The Visibility to Servers (V2S) Application Suite is not to be installed on virtual server hosts; however, Visibility to Everything (V2E) requires a Simple Network Management Protocol (SNMP) configuration be in place on server hosts. VA does require guest Virtual Machines (VM’s) have the V2S Application Suite installed:

· MacAfee Virus Scan Enterprise

· McAfee Host Intrusion Prevention (HIPS)

· McAfee ePolicy Agent

· System Center Configuration Manager Client (SCCM)

· BigFix

· SNMP

· ENCASE

The attached 6550 form and the attached Manufacturer Disclosure Statement for Medical Device Security form must be completely filled out and submitted with your proposal.

Attachment A Individual Orders – Delivery Orders and Purchase Orders will be issued by a Contracting Officer. No other methodology for ordering is acceptable. Only warranted Contracting Officers have the authority to issue Delivery Orders and Purchase Orders.

Delivery – Delivery is required within ten days After Receipt of Order for all Delivery Orders and Purchase Orders issued against the awarded IDIQ.

All deliveries shall be made to the following addresses:

Canandaigua VA Medical Center Attention: Pathology & Laboratory Medicine 400 Fort Hill Avenue Canandaigua, NY14424

Shipping – All Delivery Orders placed against the awarded IDIQ are to be shipped FOB Destination.

Invoices – The obligation of funds will occur at the Delivery Order level. Each Delivery Order will have a separate corresponding Purchase Order for each of the three sites. To receive payment, the Contractor must invoice against the Purchase Order associated with the corresponding Delivery Order. Invoicing must be submitted electronically through the Tungsten Network.

Base Year (March 1, 2023 – February 29, 2024)

Option Year 1 (March 1, 2024 – February 29, 2025)

Option Year 2 (March 1, 2025 – February 29, 2026)

Option Year 3 (March 1, 2026 – February 29, 2027)

Option Year 4 (March 1, 2027 – February 29, 2028)

For unit pricing purposes only, the Contractor’s proposal shall consider the following annual need estimate of 131,930 tests each year. This annual testing estimate is for all five sites combined.

Note: This is an annual estimate of the Urinalysis Chemistry and Automated Microscopic Testing for all three sites combined. These are not required minimum purchases. The Government is not obligated to purchase any specific quantity of any specific item under the awarded IDIQ.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

STATEMENT OF WORK – Clinical Urinalysis Cost Per Test

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C.