Combined Synopsis Solicitation - Electrophoresis Testing.pdf

Combined Synopsis-Solicitation for Commercial Products and Commercial Services

Effective Date: 03/15/2023 Revision: 01

Description

This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2025-03.

This solicitation is not set-aside and allows for Full and Open competition.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334516 - Analytical Laboratory Instrument Manufacturing, with a small business size standard of 1,000 employees.

The FSC/PSC is 6640 – Laboratory Equipment and Supplies.

The Network Contracting Office 02, 130 W. Kingsbridge Road, Building 16, Bronx, NY 10468, is seeking to purchase Electrophoresis Testing for the Albany, Buffalo, and Syracuse VA Medical Center Laboratories.

For unit pricing purposes only, the Contractor’s submission shall consider the following annual estimate of 4,836 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.

All interested companies shall provide quotations for the following:

Year 1: April 1, 2025 – March 31, 2026

CLIN Item # Item Description Unit Price per Test 0001 SPEP Testing - Albany Job 0002 SPEP Testing - Buffalo Job 0003 SPEP Testing - Syracuse Job 0004 UPEP Testing - Albany Job 0005 UPEP Testing - Buffalo Job 0006 UPEP Testing - Syracuse Job

Revision: 01

Year 2: April 1, 2026 – March 31, 2027

CLIN Item # Item Description Unit Price per Test 1001 SPEP Testing - Albany Job 1002 SPEP Testing - Buffalo Job 1003 SPEP Testing - Syracuse Job 1004 UPEP Testing - Albany Job 1005 UPEP Testing - Buffalo Job 1006 UPEP Testing - Syracuse Job 1007 IFE Testing - Albany Job 1008 IFE Testing - Buffalo Job 1009 IFE Testing - Syracuse Job 1010 CSF/Oligoclonal Testing - Syracuse Job

Year 3: April 1, 2027 – March 31, 2028

2001 SPEP Testing - Albany Job 2002 SPEP Testing - Buffalo Job 2003 SPEP Testing - Syracuse Job 2004 UPEP Testing - Albany Job 2005 UPEP Testing - Buffalo Job 2006 UPEP Testing - Syracuse Job 2007 IFE Testing - Albany Job 2008 IFE Testing - Buffalo Job 2009 IFE Testing - Syracuse Job 2010 CSF/Oligoclonal Testing - Syracuse Job

Year 4: April 1, 2028 – March 31, 2029

3001 SPEP Testing - Albany Job 3002 SPEP Testing - Buffalo Job 3003 SPEP Testing - Syracuse Job 3004 UPEP Testing - Albany Job

0007 IFE Testing - Albany Job 0008 IFE Testing - Buffalo Job 0009 IFE Testing - Syracuse Job 0010 CSF/Oligoclonal Testing - Syracuse Job

Revision: 01

3005 UPEP Testing - Buffalo Job 3006 UPEP Testing - Syracuse Job 3007 IFE Testing - Albany Job 3008 IFE Testing - Buffalo Job 3009 IFE Testing - Syracuse Job 3010 CSF/Oligoclonal Testing - Syracuse Job

Year 5: April 1, 2029 – March 31, 2030

Statement of Work

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 Cerebal Spinal Fluid (CSF)/ Oligoclonal

Bands. This testing is used for diagnsosis and treatment of Multiple Myeloma, Nephrotic

Syndrom, 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

CLIN Item # Item Description Unit Price per Test 4001 SPEP Testing - Albany Job 4002 SPEP Testing - Buffalo Job 4003 SPEP Testing - Syracuse Job 4004 UPEP Testing - Albany Job 4005 UPEP Testing - Buffalo Job 4006 UPEP Testing - Syracuse Job 4007 IFE Testing - Albany Job 4008 IFE Testing - Buffalo Job 4009 IFE Testing - Syracuse Job 4010 CSF/Oligoclonal Testing - Syracuse Job

Revision: 01 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 Laboratory Medical Centers.

1.3. ESTIMATED USAGE: 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 28 tests a month, IFE 6 tests a month, Buffalo: SPEP 50 tests a month, UPEP 40 tests a month, and IFE 50 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 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. These monthly testing numbers are best estimates only derived from past patient care. The Guaranteed Minimum dollar amount to be executed between the date of contract award and 9/30/2025 is

$20,000.00.

1.4. TERM OF CONTRACT: This will be a single award, firm-fixed price IDIQ Contract for five years. 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 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, 2025 through March 31, 2026.

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.

Revision: 01

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, 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 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 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

Revision: 01 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/monthly Preventive Maintenance is the responsibility of the

Laboratory Technicians. (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 performing electrophoresis testing for

SPEP, UPEP, IFE, and CSF/Oligoclonal.

2.2.2.2. Contractor shall supply all instrumentation, reagents, supplies, and consumables to perform approximately 4,836 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).

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: Serum protein electrophoresis, Urine protein electrophoresis, Immuno-Fixation

Electrophoresis and Cerebral spinal fluid for Oligoclonal bands. Refer to section 1.1 above.

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. The table

Revision: 01 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 section 1.1 above.

2.4.2.2 Sufficient capacity and throughput to meet the volume and service demands as defined in section 1.3 above.

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

Revision: 01

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 automated agarose gel electrophoresis instrument for SPEP, UPEP, IFE, and CSF/Oligocolonal testing.

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

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

2.4.3.4 Scanner required for the identification of protein fractions.

2.4.3.5 Independent and separate self contained assay kits.

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

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

2.4.3.8 Software program to allow for viewing of previous patient results to compare with current testing.

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 when required, as part of their cost per test pricing.

Revision: 01

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 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

Revision: 01

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 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 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 Sites 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 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

Revision: 01

Eastern Standard Time 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 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. 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 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 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, 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

Revision: 01

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 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

Revision: 01 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:

2.4.7.8.3.1 Barium (Total)

2.4.7.8.3.2 Cadmium (Total)

2.4.7.8.3.3 Chromium (Total)

2.4.7.8.3.4 Copper (Total)

2.4.7.8.3.5 Cyanide (Total)

2.4.7.8.3.6 Lead (Total)

2.4.7.8.3.7 Mercury (Total)

2.4.7.8.3.8 Nickel (Total)

2.4.7.8.3.9 Silver (Total)

2.4.7.8.3.10 Zinc (Total)

2.4.7.8.3.11 Arsenic (Total)

2.4.7.8.3.12 Selenium (Total)

2.4.7.8.3.13 Tin (Total)

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 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

Revision: 01 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 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 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 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 days from the award of the Contract, the awarded

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 awarded Contract 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 Contract at an effectiveness level of 90% or more.

Revision: 01

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 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 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 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 90% in each month of the term of the Contract for the equipment.

Revision: 01

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 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 the 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 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/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

Revision: 01 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 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; 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.

Baseline Configurations

Microsoft Windows Server

Revision: 01

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

- Windows Server 2019

- Windows Server 2022

Microsoft Windows OS Desktop and Laptop

- Windows 10

Microsoft Windows Medical Device Protection Program (MDPP)

- Windows 10 Pro

- Windows 10 LTSB

- Windows 10 LTSC

Macintosh Mac OS Workstation and Laptop

- Mac OS 12.7.X Monterey

- Mac OS 13.6.X Ventura

- Mac OS 14.6 Sonoma

Linux

- Red Hat Enterprise Linux 8

- Red Hat Enterprise Linux 9

Database Platforms SQL

- SQL Server 2019

- SQL Server 2022

Oracle

- Oracle 12c

- Oracle 19c

- Oracle 21c

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 offer.

The Indefinite Delivery/Indefinite Quantity contract period of performance is April 1, 2025 – March 31, 2030, to include a base requirement period of performance of April 1, 2025 – March 31, 2026, and four (4) twelve (12) month Option periods.

Delivery terms – FOB Destination.

Place of Performance/Place of Delivery

Address: Albany VA Medical Center Attention: Pathology & Laboratory Medicine 113 Holland Avenue Albany, NY 12208

Buffalo VA Medical Center Attention: Pathology & Laboratory Medicine 3495 Bailey Avenue Buffalo, NY 14215

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

Country: UNITED STATES

Deliveries for each facility will be coordinated with the applicable point of contact identified in the contract. Delivery is required within ten (1) days after receipt of order for all Delivery Orders and Purchase Orders issued against the awarded IDIQ. All deliveries shall be made to the addresses identified above.

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

http://acquisition.gov/comp/far/index.html

Revision: 01

The following solicitation provisions apply to this acquisition:

1. FAR 52.212-1, “Instructions to Offerors–Commercial Products and Commercial Services”

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (SEP 2023)

Provisions that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The version of FAR 52.212-1 in the addendum is tailored for Simplified Acquisition Procedures and supersedes the current version of FAR 52.212-1 contained in the FAR.

The following provision is incorporated into 52.212-1 as an addendum to this solicitation:

52.212-1 Instructions to Offerors—Commercial Products and Commercial Services (SEP 2023)

(a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code(s) and small business size standard(s) for this acquisition appear elsewhere in the Request for Quote (RFQ). However, the small business size standard for a concern that submits an quote, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce is 500 employees, or 150 employees for information technology value-added resellers under NAICS code 541519, if the acquisition—

(1) Is set aside for small business and has a value above the simplified acquisition threshold;

(2) Uses the HUBZone price evaluation preference regardless of dollar value, unless the offeror waives the price evaluation preference; or

(3) Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value.

(b) Submission of Quotes. Submit signed and dated quotes to the office specified in this Request for Quote (RFQ) at or before the exact time specified in this solicitation. Quotes may be submitted on letterhead stationery, or as otherwise specified in the solicitation. As a minimum, quotes must show—

(1) The solicitation number;

(2) The time specified in the solicitation for receipt of quotations;

Revision: 01

(3) The name, address, and telephone number of the quoter;

(4) A technical description of the items being quoted in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary;

(5) Terms of any express warranty;

(6) Price and any discount terms;

(7) "Remit to" address, if different than mailing address;

(8) A completed copy of the representations and certifications at Federal Acquisition Regulation (FAR) 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically);

(9) Acknowledgment of Quotation Amendments;

(10) Quotes should include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Quotes that fail to furnish required representations, or information, or reject the terms and conditions of the solicitation may be excluded from consideration.

(c) Period for acceptance of Quotes. The offeror agrees to hold the prices in its offer firm for 30 calendar days from the date specified for receipt of quotes, unless another time period is specified in an addendum to the solicitation.

(d) Product samples. When required by the solicitation, product samples shall be submitted at or prior to the time specified for receipt of quotes. Unless otherwise specified in this solicitation, these samples shall be submitted at no expense to the Government, and returned at the sender’s request and expense, unless they are destroyed during preaward testing.

(e) Late submissions, modifications, revisions, and withdrawals of quotes.

(1) Quoters are responsible for submitting quotes, and any modifications, revisions, or withdrawals, so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that quotes or revisions are due.

(2) Any quote received at the Government office designated in the solicitation after the exact time specified for receipt of quotes is "late" and may not be considered unless it is received before purchase order issuance and the Contracting Officer determines that accepting the late quote would not unduly delay the acquisition.

https://www.acquisition.gov/far/part-52#FAR_52_212_3 https://www.acquisition.gov/far/part-52#FAR_52_212_3

Revision: 01

(3) If an emergency or unanticipated event interrupts normal Government processes so that quotes cannot be received at the Government office designated for receipt of quotes by the exact time specified in the Request for Quote, and urgent Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of quotes will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

(g) Issuance of Contract. The Government may issue a contract to one or more quoters as identified in the Request for Quote (RFQ). Therefore, the quoter’s initial quote should contain the best terms from a price and technical standpoint.

However, the Government may reject any or all quotes if such action is in the public’s best interest. In addition, the Contracting Officer (CO) may issue a contract to other than the quoter with the lowest quoted price.

(h) Multiple awards. The Government may accept issue a contract for any item or group of items of a quotation, unless the quoter qualifies the quotation by specific limitations.

Unless otherwise provided in the quotation, offers may not be submitted for quantities less than those specified in the RFQ. The Government reserves the right to issue a contract for a quantity less than the quantity quoted, at the unit prices quoted, unless the quoter specifies otherwise in the quote.

(i) Availability of requirements documents cited in the solicitation.

(1)

(i) The GSA Index of Federal Specifications, Standards and Commercial Item Descriptions, FPMR Part 101–29, and copies of Federal specifications, standards, and product descriptions can be downloaded from the ASSIST website at https://assist.dla.mil.

(ii) If the General Services Administration, Department of Agriculture, or Department of Veterans Affairs issued this solicitation, a copy of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained from the address in paragraph (i)(1)(i) of this provision.

(2) Most unclassified Defense specifications and standards may be downloaded from the ASSIST website at https://assist.dla.mil.

(3) Defense documents not available from the ASSIST website may be requested from the Defense Standardization Program Office by—

(i) Using the ASSIST feedback module ( https://assist.dla.mil/feedback); or https://assist.dla.mil/ https://assist.dla.mil/ https://assist.dla.mil/feedback

Revision: 01

(ii) Contacting the Defense Standardization Program Office by telephone at 571–767–6688 or email at assisthelp@dla.mil.

(4) Nongovernment (voluntary) standards must be obtained from the organization responsible for their preparation, publication, or maintenance.

(j) Unique entity identifier.(Applies to all quotes that exceed the micro-purchase threshold, and quotes at or below the micro-purchase threshold if the Request for Quote (RFQ) requires the Contractor to be registered in the System for Award Management (SAM).) The quoter shall enter, in the block with its name and address on the cover page of its offer, the annotation "Unique Entity Identifier" followed by the unique entity identifier that identifies the Quoter's name and address. The Quoter also shall enter its Electronic Funds Transfer (EFT) indicator, if applicable. The EFT indicator is a four-character suffix to the unique entity identifier. The suffix is assigned at the discretion of the Quoter to establish additional SAM records for identifying alternative EFT accounts (see FAR subpart 32.11) for the same entity. If the Quoter does not have a unique entity identifier, it should contact the entity designated at www.sam.gov for unique entity identifier establishment directly to obtain one. The Quoter should indicate that it is an planning to submit a quote for a Government Request for Quote (RFQ) when contacting the entity designated at www.sam.gov for establishing the unique entity identifier.

(k) [Reserved]

(l) Notification. The CO will not notify unsuccessful quoters that responded to this Request for Quotation (RFQ).

(m) Implementation Plan. The Contractor shall provide with their quote 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 Contract including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., and performance of all correlations and validations.

52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

http://www.acquisitio…