36C24218Q0291-007.docx

36C24218Q0291

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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.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C24218Q0291 03-28-2018

SPATUZZI, MICHAEL

518-626-6984 04-19-2018

4:00 PM

Department of Veterans Affairs Samuel S . Stratton VA Medical Center 113 Holland Avenue (2-90NCA) Albany NY 12208-3410 X X 334516 1000 Employees N/A X Department of Veterans Affairs VA Western NY Healthcare System 3495 Bailey Avenue Buffalo NY 14215-1129 Department of Veterans Affairs Samuel S . Stratton VA Medical Center Network Contracting Activity 113 Holland Avenue (2-90NCA) Albany NY 12208-3410

Tungsten Network http://www.tungsten-network.com/us/en /veterans-affairs

See CONTINUATION Page This solicitation is for an Indefinite Delivery, Indefinite Quantity (IDIQ) Contract for a configuration flow cytometer to perform a cost per reportable. Specifically, the requirement is for a ten color configuration flow cytometer for the VA Western NY Healthcare System located in Buffalo, NY.

The three evaluation factors spelled out in great detail need to be thoroughly addressed in your proposal documents.

The awarded IDIQ Contract shall be for five years with the period of performance beginning in May 2018.

See CONTINUATION Page X X X Michael Spatuzzi

NCO216L2-81072

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

(continuation from Standard Form 1449, block 18A.)

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 Samuel S . Stratton VA Medical Center 113 Holland Avenue (2-90NCA) Albany NY 12208-3410

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.

Tungsten Network http://www.tungsten-network.com/us/en /veterans-affairs

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

B.2 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes FAR 52.219-14 Limitations on Subcontracting. Accordingly, any contract resulting from this solicitation will include this clause. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) retained by VA to assist in assessing the contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to contractor's offices where the contractor's business records or other proprietary data are retained and to review such business records regarding the contractor's compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor's compliance with the limitations on subcontracting or percentage of work performance requirement.

B.3 SUBCONTRACTING COMMITMENTS--MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes VAAR 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, and VAAR 852.215-71, Evaluation Factor Commitments. Accordingly, any contract resulting from this solicitation will include these clauses. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) to assist in assessing contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the contractor's business records or other proprietary data to review such business records regarding contract compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor compliance with the subcontracting commitments.

36C24218Q0291

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1. LANGUAGE

1.1. INTENT: It is the intent of the Department of Veterans Affairs, specifically the VA Western NY Healthcare System Upstate New York Medical Center Laboratory located in Buffalo, NY to establish an Indefinite Delivery, Indefinite Quantity (IDIQ) Contract for a configuration flow cytometer to perform a cost per reportable. Specifically, the requirement is for a ten (10) color configuration flow cytometer. The Government will award an IDIQ Contract to a single Contractor for a flow cytometer cost per reportable and no subcontracting is authorized. The Flow Cytometer will be utilized for immunophenotyping to aid in diagnosis of malignancies and perform lymphocyte subset panels. The Contractor agrees to the following terms of the awarded Contract exclusively with the VA Western NY Healthcare System and is responsible for executing one hundred percent (100%) of the awarded IDIQ. Additional tests, reagents, and instrumentation may be added to the awarded Contract as new technology becomes available on the market and added to the awarded Contract.

1.2. ORDERS: The awarded Contract does not obligate any funds. The Government is obligated only to the extent of authorized purchase orders issued under the awarded Contract by the Contracting Officer Representative who shall be identified in writing at the time of the awarded Contract.

1.3. PRICES AND TERMS: The VA Western NY Healthcare System shall provide an estimated monthly volume by test. The following are the estimated monthly testing volumes: leukemia/lymphoma pane fifty (50) tests a month, lymph subsets fifty (50) tests a month. The Government estimates the volumes as listed above, but does not guarantee volumes as listed; they are best estimates only derived from previous and expected future patient care numbers. The shipping of all reagents, consumables, and supplies shall be FOB Destination, no exceptions.

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 terminated with thirty (30) days written notice to the Contractor by the Contracting Officer. The Contractor shall also reserve the right to terminate the awarded Contract with thirty (30) days written notification to the Contracting Officer. The awarded Contract shall be reviewed annually. The VA Western NY Healthcare System to establish the first year of the agreement for the period of May 2018 through May 2019. Please note that the specific period of performance dates will be identified in Attachment A during the Contracting award phase.

1.5. IDENTIFICATION: Delivery Orders issued shall be identified by the awarded Contract Number and the corresponding Purchase Order Number for the VA Western NY Healthcare System Laboratory.

1.6. ORDERING METHOD: The participating facility may order products 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/STATEMENTOF WORK

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, disposables, and any other materials required to properly perform tests on their equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration dates must be clearly marked on 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 should be forwarded to the Contracting Officer Representative.

2.1.4. Special handling for emergency orders of supplies: If 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 (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 and or routine supplies delivery.

2.2. DEFINITIONS:

2.2.1. Cost per Reportable (CPR) - Contractors are required to provide a price for each test that can be performed on their equipment. The per reportable price shall include costs covering: (1) Five (5) 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 Contractor’s equipment in good operating condition. This element includes both preventive maintenance and emergency repairs. (4) Training for Government personnel. The Contractor is required to provide delivery, installation, and removal of their equipment at the end of the awarded Contract at no additional charge.

2.2.2. Parameter definitions-

2.2.2.1. A fully automated system that has been on the market for at least one year and is FDA approved.

2.2.2.2. The Contractor shall supply all instrumentation, reagents, supplies, and consumables needed to perform approximately one hundred (100) patient reportable results per month.

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

2.4. GENERAL REQUIREMENTS:

2.4.1. One (1) Analyzer with a second workstation included – Base equipment offered that shall fully support the scope of operations. The minimum requirements are identified below.

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.

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

2.4.2.3.2. FDA approved software for data management of CD4/CD8 analysis and leukemia/lymphoma testing, manipulation, and interpretation by Technologists and Hematopathologist.

2.4.2.3.3. Windows 7 compatibility and hardware and software functionality for direct network connectivity.

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

2.4.2.3.5. Any connections from the analyzer back to the Contractor will follow the Department of Veterans Affairs guidelines and must be FIPS 140-2 and CRISP compliant.

2.4.2.4. Minimal daily maintenance such that the Contractor’s analyzer is not required to be down for more than sixty (60) minutes per day.

2.4.2.5. The ability to store and retransmit records twenty-four (24) hours of maximal instrument throughput in case of interface outage.

2.4.2.6. Reagent stability sufficient to accommodate both high and low volume use. The Contractor to provide expiration dates of at least six (6) months for reagents.

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

2.4.3.1. Laser requirement for ten (10) color configuration and fixed optical system.

2.4.3.2. Two (2) custom panels for leukemia/lymphoma with thirty (30) markers per panel.

2.4.3.3. An uninterruptible power supply.

2.4.3.4. Automatic and manual system compensation to include real time compensation, data analysis, and gating.

2.4.3.5. Fully digital electronics for linear and log for all corrected parameters with post acquisition electronics.

2.4.3.6. The ability to create custom test panels.

2.4.3.7. The ability to provide on board incubation, lysing, and fixing of samples.

2.4.3.8. Minimal sample carryover five percent (5%) for sample pipetting.

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

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

2.4.4.2. The Contractor to supply printer and replacement printers when required at no additional cost.

2.4.4.3. The Contractor to supply data display widescreen, flat panel LCD monitor, twenty-two (22) inches or twenty-four (24) inches diagonal.

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

2.4.4.5. The ability to read barcode labels on individual tubes.

2.4.4.6. A quality control package used for daily monitoring of system performance and operator notification upon quality control failure.

2.4.6 Method Performance/Validation Requirements

Method performance and comparison will be at the expense of the Contractor and shall include the following: all reagents, consumables, supplies, and replacement parts. Results shall be consistent with current CLSI guidelines and related documents and Federal regulations.

2.4.6.1 The Contractor shall perform method validation to include correlation study, sensitivity, precision, and carryover studies 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 analyzer during installation. These studies shall be performed using either Contractor developed program or programs developed by a third party (CAP/CLSI). The programs shall be provided to the 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 SOW, “current production” shall mean that the laboratory analyzer model being offered is new equipment. Discontinued models that are only being made available as remanufactured or refurbished equipment are not acceptable.

The Contractor shall clearly identify the primary analyzer being offered with their cost per reportable pricing. Analyzer identification shall include all the following: Analyzer full model name, Year of the Analyzer, Analyzer Manufacturer, and the version of Microsoft SQL that will be run on the Analyzer. The Contractor shall be required to complete VA Directive 6550 and the Manufacturer Disclosure Statement for Medical Device Security, which are attached with this solicitation. These two forms are mandatory as part of the Contractor’s proposal package. The Contractor is also required to identify specifically which year of the awarded Contract their Analyzer will be upgraded. If an upgrade of the analyzer will not take place during the period of performance of the awarded Contract, then the Contractor is required to clearly state that their analyzer will not be upgraded at any time during the period of performance of the awarded Contract.

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 required to establish instruments for operation for performance of acceptance testing. The Contractor shall assist to the satisfaction of the Government with 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 at no cost to the Government. The Contractor shall assist with statistical analysis as stated in the Method Performance/Validation section above and report data in an organized and clearly comprehensible format.

2.4.7.3 Training. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services. 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 year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA Western NY Healthcare System and the Contractor. A training program that involves off-site travel shall include the cost of airfare and room and board for each participant. The Contractor shall provide training for two staff pathologists which shall consist of software usage and data manipulation.

2.4.7.4 Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary instrumentation in accordance with the following terms:

2.4.7.4.1 Service Requirements

2.4.7.4.1.1 Technical support by telephone available 24 hours a day 7 days a week. Onsite service Monday through Friday from 8:00 AM to 4:30 PM with emergency service provided within 24 hours.

2.4.7.4.1.2 A current contractor Service Agreement Plan will replace equipment and or any incremental networking or support equipment within one (1) business day of a complaint being received.

2.4.7.5 Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software, excluding analyzers and related accessories, 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 upgrades” that enhance the model of equipment being offered, i.e. latest version of software, correction of hardware defect, upgrades offered to commercial customers at no additional charge, upgrades to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the awarded Contract; however, it does refer to significant changes in the hardware operational capability.

2.4.7.6 Ancillary support equipment - The Contractor shall provide, install, and maintain through the life of the awarded Contract, as indicated, all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc. 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 and stands, etc.

2.4.7.7 Commercial offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g. Computer disc containing their procedure manual in CLSI format or an on-line procedure manual in the instrument software. Support materials shall include two hard copies of the Operators Manuals and two hard copies of the Technical Manuals.

2.4.7.8 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 decide if the waste is a hazardous waste or otherwise regulated.

2.4.7.8.1 The determination and description shall address the following:

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

2.4.7.8.1.2 Waste ignitability (Reference 40 CFR §261.21)

2.4.7.8.1.3 Waste corrosivity (Reference 40 CFR §261.22)

2.4.7.8.1.4 Waste reactivity (Reference 40 CFR §261.23)

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

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

2.4.7.8.1.7 Solid Waste (Reference 40 CFR §261.2)

2.4.7.8.1.8 Exclusions (Reference 40 CFR §261.4)

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

2.4.7.8.3 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), Federal, and New York State 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:

2.4.7.8.3.14 pH

2.4.7.8.3.15 Flash point (to higher than 200F)

2.4.7.8.3.16 BOD; biochemical oxygen demand

2.4.7.8.4 The documentation the Contractor provides will be used to work with the VA Medical Center and the public and/or private organization (e.g., POTW) to determine whether the waste from each device can legally be disposed of via the sewerage system.

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

2.4.7.9.1 Upon award of the Contract, the transition period for the awarded Contract to have all equipment and peripherals installed and operational shall be from the date of award through ninety (90) days. During this same period, all initial training of VA Laboratory personnel in the operation and maintenance of said equipment shall also be completed.

2.4.7.9.2 The Contractor shall provide with their proposal an implementation plan for installation of their equipment. The Contractor’s submitted plan shall not exceed ninety (90) days for the transition of all services under the awarded Contract including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., 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 Contract for cause under the Termination for Cause clause of the awarded Contract.

2.4.7.9.3 At the end of ninety (90) days from the award of the Contract, the Contractor shall have full and sole responsibility for services under the awarded Contract.

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 Delivery Order, awarded Contract, or Purchase Order 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 (30) consecutive calendar days by operating in conformance with the Contractor’s technical specification or as quoted in the awarded Contract at an effectiveness level of 90% or more.

2.4.8.3 If the equipment does not meet the standard of performance during the initial period of thirty (30) consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of thirty (30) consecutive days.

2.4.8.4 If the equipment fails to meet the standard of performance after ninety (90) calendar days from the installation date, the Laboratory may at their option request a replacement or terminate the awarded Contract 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 (90) acceptance period.

2.4.8.5 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 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.

2.4.8.6 During the performance period for a system, a minimum of one hundred (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 more than the minimum of one hundred (100) hours.

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

2.4.8.8 During the term of the awarded Contract, should the repair record of any individual piece of Laboratory equipment reflect a downtime of ten percent (10%) or greater of the normal working days in one calendar month, a determination shall be made by the Contracting Officer Representative 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 ninety percent (90%) in each month of the term of the agreement for equipment.

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

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 returned to the Contractor. The Contractor, upon expiration of the awarded Contract, at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer.

2.4.11 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/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility.

2.4.12 Prior to termination or completion of the awarded Contract, the Contractor must not destroy information received from the VA, or gathered and created by the Contractor in the course of performing the awarded Contract without prior written approval by the VA. Any data destruction done on behalf of the VA by the 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 (30) days of termination or completion of the awarded Contract.

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 Contract or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the Contractor 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 awarded Contract 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:

2.4.14.3 Contractor must accept the system without the drive;

2.4.14.4 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

2.4.14.5 VA must reimburse the company for media at a reasonable open market replacement cost at 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 VA Medical Center to retain the hard drive, then;

2.4.15.1 The Contractor must have an existing 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 Contract.

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.

Department of Veterans Affairs 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 7

Microsoft Windows Medical Device Protection Program (MDPP)

· Windows 7

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:

· McAfee Virus Scan Enterprise

· McAfee Host Intrusion Prevention (HIPS)

· McAfee ePolicy Agent

· System Center Configuration Manager Client (SCCM)

· BigFix

· SNMP

· ENCASE

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 – All deliveries shall be made to the following address:

VA Western NY Healthcare System Attention: Pathology & Laboratory Medicine 3495 Bailey Avenue Buffalo, NY 14215

Shipping – All delivery orders and purchase orders placed against the awarded IDIQ Contract shall be shipped FOB Destination.

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

Ordering Period: May 2018 through May 2023

May 2019 – May 2020

For unit pricing purposes only, please consider the following annual need estimate of 1,200 tests each year.

Note: This is an annual estimate of testing requirements. These are not required minimum purchases. The Government is not obligated to purchase any specific quantity of any specific item under the awarded IDIQ Contract.

52.212-2 EVALUATION--COMMERCIAL ITEMS (OCT 2014)

(a) The Government shall award a contract resulting from this solicitation to the responsible Offeror whose offer conforming to the solicitation shall be most advantageous to the Government. The following factors shall be used to evaluate offers: Technical Approach and Capabilities, Past Performance, and Price.

In accordance with FAR 13.106-2 Evaluation of quotations or offers, a tradeoff process shall be used. The Government shall make a single award for this requirement. To be considered for award, all requirements listed in the Statement of Work (SOW) must be met or exceeded. Offeror’s proposals cannot take exceptions to any of the requirements identified in the SOW, otherwise their offer will not be considered for contract award.

i. The Government will award a contract from this solicitation to the responsible Offeror whose proposal provides the best value to the Government.

ii. Technical Approach and Capabilities is more important than Past Performance and Price. The sub factors identified in Factor I under Technical Approach and Capabilities are considered to be amongst the most important technical factors, but all technical factors listed in the SOW are of importance when it comes to meeting the testing requirements listed in the SOW. Past Performance is more important than Price.

iii. The Contracting Officer shall conduct a price evaluation in accordance with FAR 12.209 Determination of price reasonableness. Offerors are reminded that award may not necessarily be made to the Offeror with the lowest price.

iv. To receive consideration for award, proposals must receive an overall rating of no less than:

Acceptable for the overall rating under Factor I, Technical Approach and Capabilities and Unknown Risk for Factor II Past Performance. Price must be determined to be Fair and Reasonable in accordance with FAR 12.209 Determination of price reasonableness.

v. Offerors will be required to submit their Technical Approach and Capabilities, Past Performance, and Cost per Reportable Pricing. Offerors proposals shall be evaluated against these three evaluation factors. To determine which Offerors proposal represents the best value to the Government, the Offerors proposal will be evaluated against these three evaluation factors identified in the below paragraphs.

FACTOR I – Technical Approach and Capabilities: The Offeror shall provide supporting documents that they possess adequate resources, capabilities, experience, responsibility, and integrity to meet all requirements of the SOW. This shall include the below technical requirements, but it is not limited to only these ten below technical requirements:

i. FDA approved software for data management of CD4/CD8 analysis and leukemia/lymphoma testing, manipulation, and interpretation by Technologists and Hematopathologist.

ii. Minimal daily maintenance such that the Contractor’s analyzer is not required to be down for more than sixty (60) minutes per day.

iii. Laser requirement for ten (10) color configuration and fixed optical system.

iv. Automatic and manual system compensation to include real time compensation, data analysis, and gating.

v. The ability to create custom test panels.

vi. The ability to provide on board incubation, lysing, and fixing of samples.

vii. Ability to perform the complete profile as described in the SOW and to 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).

viii. Technical support by telephone available 24 hours a day 7 days a week. Onsite service Monday through Friday from 8:00 AM to 4:30 PM Eastern Standard Time with emergency service provided within 24 hours. The ability to provide emergency equipment repairs on all primary instrumentation.

ix. The Contractor shall provide with their proposal an implementation plan for installation of their equipment to meet the ninety (90) day time frame upon contract award.

x. Reagent stability sufficient to accommodate both high and low volume use. Contractor to provide expiration dates of at least six (6) months for reagents.

Technical Capabilities responses must be addressed on separate documents.

FACTOR II - Past Performance: Offerors shall provide a minimum of three (3) references of current contracts or contracts within…