36C24219Q0050-004.docx

36C24219Q0050

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.

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

36C24219Q0050 11-23-2018

SPATUZZI, MICHAEL

518-626-6984 12-21-2018

5:00 PM

Department of Veterans Affairs Samuel S . Stratton VA Medical Center 113 Holland Avenue (2-90NCA) Albany NY 12208-3410 X 334516 1000 Employees N/A X Department of Veterans Affairs Stratton VA Medical Center VA Western NY Healthcare System Syracuse VA Medical Center Albany, Buffalo, and Syracuse NY 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 electrophoresis cost per test.

This testing requirement is for the Albany, Buffalo, and Syracuse VA Medical Centers Laboratories.

The awarded IDIQ Contract shall be for five years with the period of performance beginning on April 1, 2019.

See CONTINUATION Page X X X Michael Spatuzzi

NCO

216L2-81072

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 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:

Page 1 of Page 1 of

1. 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, and Syracuse to establish an Indefinite Delivery, Indefinite Quantity, (IDIQ) Contract for Electrophoresis testing to perform a cost per test. This requirement is for Electrophoresis testing of Serum Protein Electrophoresis (SPEP), Urine Protein Electrophoresis (UPEP), Immuno-Fixation Electrophoresis (IFE) by Gel Electrophoresis, and Cerebral Spinal Fluid (CSF)/Oligoclonal Bands. This testing is used for diagnsosis and treatment of Multiple Myeloma, Nephrotic Syndrome, Multiple Sclerosis, and Liver Cirrhosis. The Government shall award a Contract to a single Contractor for cost per test Electrophoresis testing and subcontracting is not authorized. The Contractor agrees to the following terms of the awarded Contract exclusively with all three of the Upstate New York VA Medical Centers Laboratories and is responsible for executing 100% of the awarded 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 three Laboratory Medical Centers.

1.3. PRICES AND TERMS: The three Upstate New York VA Medical Centers Laboratories will provide an estimated monthly testing volume for each of the four required tests. The following are the estimated monthly testing volumes for each Laboratory. Albany: SPEP 53 tests a month, UPEP 20 tests a month, IFE 6 tests a month, and CSF/Oligoclonal 1 test a month. Buffalo: SPEP 50 tests a month, UPEP 30 tests a month, and IFE 20 tests a month. Syracuse: SPEP 125 tests a month, UPEP 30 tests a month, IFE 20 tests a month, and CSF/Oligoclonal 1 test a month. Pricing is based on cartridge price plus add on. Add on is figured by equipment at the facility divided by the average monthly 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 three Laboratories shall 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. These monthly testing numbers provided by each of the three Laboratories are best estimates only derived from past patient care numbers.

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 three Upstate New York VA Medical Centers Laboratories shall establish the first year of the Contract for the period from April 1, 2019 through March 31, 2020.

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 three Laboratories 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

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. The 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 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 three 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 Laboratory 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 must provide services such as but not limited to: interface with Laboratories 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 three Laboratories requires its own Middleware Server.

2.2. DEFINITIONS:

2.2.1. Cost per Test (CPT) - The Contractor is required to provide a price for each test that can be performed on their 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. All products to be shipped FBO Destination – no exceptions. (3) All necessary maintenance to keep the equipment fully operational to include emergency repairs. Daily, weekly, and monthly Preventive Maintenance is the responsibility of the Laboratory Technicians. (4) Training for Government personnel. (5) The 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 can perform electrophoresis testing for SPEP, UPEP, IFE, and CSF/Oligoclonal.

2.2.2.2. The Contractor shall supply all instrumentation, reagents, supplies, and consumables to perform approximately 4,272 patient test results per year. Please note that this patient testing amount is the estimated total yearly number for all three Laboratories combined for all four tests.

2.2.2.3. Calibrators traceable to International Federation of Clinical Chemistry (IFCC). The 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 One Analyzer for Each Site – Base equipment offered that shall fully support the scope of operations while meeting all minimal requirements of operation.

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 three Laboratories simultaneously.

2.4.2.4.1 The 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 7 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 Department of Veterans Affairs 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 instrument maintenance shall require no more than ten minutes to complete.

2.4.2.6 Technician 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 Muti-parameter semi-automated agarose gel electrophoresis instrument for SPEP, UPEP, IFE, and CSF/Oligocolonal testing.

2.4.3.2 Walk away after sample inoculation.

2.4.3.3 Sequenced sample application, migration, incubation, staining, destaining, and drying.

2.4.3.4 High voltage protein separation and direct protein detection of the following five protein zones: Albumin, Alpha-1, Alpha-2, Beta, and Gamma.

2.4.3.5 Scanner required for the identification of protein fractions.

2.4.3.6 Independent and separate self contained assay kits.

2.4.3.7 Software compatible with instrumentation to provide complete patient deomographic, curve editing, modification of the baseline, fraction identification, and curve overlay.

2.4.3.8 Software to provide a comprehensive patient report with electrophoretic curve, immunofixation pattern, and quantitive specific protein results.

2.4.3.9 A comprehensive quality control program with two levels of quality control to include Levy-Jennings charts.

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 shall supply a printer, replacement printers if required, and toner cartridges 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 three sites, all validation studies to include: 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 their 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 three sites.

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 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 their 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 three Laboratory Medical Directors.

2.4.7.3 Training. The Contractor shall provide an instrument training program, as well as onsite training, that is coordinated with and timely to the equipment installation, sufficient to the size and scope of each of the three Laboratories. 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 Laboraotry 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 Laboratories 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 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:

2.4.7.4.1 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 5:00 PM with emergency service provided within 24 hours. The ability to provide emergency equipment repairs on all primary instrumentation.

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 business day of 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, 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. latest 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 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, 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, 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, to include a Computer Disc containing their procedure manual in CLSI format or an on-line procedure manual in the instrument software.

2.4.7.8 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 make a determination 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 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.

2.4.7.8.3 The Contractor shall provide a description of all wastes their equipment may discharge so that the Laboratory 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 Laboratories 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 the Contractors proposal:

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 Centers to determine whether or not the waste from each device can legally be disposed of via the sewerage system.

2.4.7.8.5 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.

2.4.7.9 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 Contract award date. This ninety day timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated ninety day 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.

2.4.7.9.1 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 days. During this ninety day time 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 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 ninety day time period all initial validations shall be completed to the satisfaction of each of the three Laboratory Directors.

2.4.7.9.2 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 requirements 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 days from the award of the Contract, the awarded Contractor shall have full and sole responsibility for all requirements identified in this Statement of Work 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 awarded Contract is accepted by the Government. This 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 specifications or as specified in the awarded Contract at an effectiveness level of 90% or greater.

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 calendar days.

2.4.8.2 If the equipment fails to meet the standards 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 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 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 account representative 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 Contract, 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 the manufacturer’s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of at least 90% in each month of the term of the Contract for the equipment.

2.4.9 Government’s Responsibility- The Laboratory Technicians shall perform routine preventive maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The Laboratory Technicians shall maintain written records to satisfy the required preventive 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 Contract 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 their analyzers from each of the three Laboratories.

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 Laboratories.

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 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 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 or any person acting on behalf of the Contractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors 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 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:

2.4.14.1 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.

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.

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 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 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:

· 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 (MDS) 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:

Syracuse VA Medical Center

Attention: Pathology & Laboratory Medicine 800 Irving Avenue Syracuse, NY 13210

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 corresponding Purchase Order. To receive payment, the Contractor must invoice against the Purchase Order associated with the corresponding Delivery Order. Invoices must be submitted electronically through the Tungsten Network against the correct Purchase Order Number.

Ordering Period: April 1, 2019 through March 31, 2024

Year 1: April 1, 2019 – March 31, 2020

Year 2: April 1, 2020 – March 31, 2021

Year 3: April 1, 2021 – March 31, 2022

Year 4: April 1, 2022 – March 31, 2023

Year 5: April 1, 2023 – March 31, 2024

For unit pricing purposes only, the Contractor’s proposal shall consider the following annual need estimate of 4,272 tests each year. This annual testing estimate is for all three Laboratories combined.

Note: This is an annual estimate of the four required tests for all three Laboratories 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

See attached document: 6550 Form.

See attached document: Manufacturer Disclosure Statement for Medical Device Security.

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 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 amongst the most important technical factors, but all technical factors listed in the SOW are of importance when it comes to meeting the electrophoresis testing requirements for each of the Three Laboratories. 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 proposal.

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 Test Pricing.