Attachment B - SOW.docx

STATEMENT OF WORK – Glycohemoglobin A1C Analyzer

1. INTRODUCTION OF REQUIREMENTS

1.1. SCOPE OF PROCUREMENT:

1.1.1. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument shall have random access capability (if discrete testing is required) be able to simultaneously perform the complete profile as described below 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).

1.1.2. Equipment must maintain or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory.

1.1.3. If Contractor offers a family of analyzers, VISN 22 technical evaluation panel will determine if instrumentation proposed meets needs of using facility.

1.1.4. Equipment shall be acquired for each of the clinical laboratories located at the VISN facilities listed in Attachment A.

1.1.5. 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 FDA-approved, if available, and of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award.

1.1.6. Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the Contractor’s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

1.2. DEFINITIONS:

1.2.1. Cost per Test (CPT) – Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (1) base year equipment use plus 4 optional years, (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation and reporting of a test result, (3) software licenses, (4) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs), (5) ancillary equipment including, but not limited to, printers and Uninterrupted Power Supply (UPS), and (6) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge.

1.2.2. Business Associate Agreement (BAA) - A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receive, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule.

1.3. TEST MENU - Refer to Attachment A for desired test menu and estimated annual volumes.

2. DESCRIPTION / SPECIFICATIONS / STATEMENT OF WORK

2.1. MINIMUM SYSTEM REQUIREMENTS:

2.1.1. Primary analyzer(s) – Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all of the technical specifications of this solicitation. Due to efficient and reliable operational needs, the 2nd analyzer must be completely redundant to the primary analyzer.

Meets the minimum requirement described in Section 2.1.1 above (y/n)?

Describe how the minimum requirement is met or exceeded:

File name of Contractor’s attachment, if providing additional supporting documentation:

2.1.2. Parameter Definitions-

2.1.2.1. The system must be certified by the National Glycohemoglobin Standardization Program.

Meets the minimum requirement described in Section 2.1.2 above (y/n)?

Describe how the minimum requirement is met or exceeded:

File name of Contractor’s attachment, if providing additional supporting documentation:

2.1.3. Operational Features- The instrumentation offered shall have the following:

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

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

2.1.3.2.1. The maximum turn-around time between samples must be less than 2 minutes or a throughput of at least 30 results per hour.

2.1.3.3. 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.

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

2.1.3.3.1. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.

2.1.3.3.2. Equipment must accept, at a minimum, BCBC characters in specimen identifier that is alpha and/or numeric depending on site.

Capability to load a single specimen for priority testing.

2.1.3.4. Maintenance protocols and time stated to perform procedures shall be provided by each vendor.

2.1.3.5. Capability to store and/or archive at least 100,000 patient results in database for immediate recall.

2.1.3.6. On board reagent stability sufficient to accommodate both high and low volume use. Contractor to provide expiration dates of at least three (3) months for reagents.

2.1.3.7. No requirements for sample pre-treatment.

2.1.3.8. A specimen handling/loading system;

2.1.3.8.1. Primary specimen container(s) loaded into a storage area, e.g. tray, rack, wheel, etc. for automated processing.

2.1.3.8.2. Ability to accept various types of sample containers.

2.1.3.9. Reagents must be in a ready-to-use format (i.e. liquid ready).

Meets the minimum requirement described in Section 2.1.3 above (y/n)?

Describe how the minimum requirement is met or exceeded:

File name of Contractor’s attachment, if providing additional supporting documentation:

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

2.1.4.1. Perform hemoglobin A1C measurements via methodology HPLC (high performance liquid chromatography) or capillary electrophoresis .

2.1.4.2. Ability to monitor instrument performance.

2.1.4.3. On Board reagent inventory system.

2.1.4.4. Vendor shall provide data indicating length of calibration stability for each assay.

2.1.4.5. Instruments should have full walk-away capabilities when samples are loaded by staff.

2.1.4.6. Internal ability to assess column and detector functionality over time. A method for the determination of column and detector integrity must be provided (applicable to HPLC methodology only).

2.1.4.7. Complete separation of the labile and stabile hemoglobin A1C results.

2.1.4.8. Methodology that provides minimal interference from common hemoglobin (Hb) variants. Vendor will provide list of hemoglobin variants that interfere with the assay. The list should indicate at what level the variant interferes with assay.

2.1.4.9. Vendor shall provide graphs indicating any hemoglobin variant that will interfere with the assay.

Testing shall not be negatively affected by high-altitudes or humidity factors.

Meets the minimum requirement described in Section 2.1.4 above (y/n)?

Describe how the minimum requirement is met or exceeded:

File name of Contractor’s attachment, if providing additional supporting documentation:

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

2.1.5.1. A total equipment footprint along with peripheral devices when installed in the laboratory shall not impact the functionality/operations of that laboratory.

2.1.5.2. The instrument should include an on-board monitor/screen that is easily readable. Vendor shall provide information regarding resolution of on-board screen.

2.1.5.3. A printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient’s name and accession or unique identifier number (UID).

2.1.5.4. An uninterruptible power supply with line conditioner for each instrument provided.

2.1.5.5. An auto sampling system that includes cap piercing closed tube aspiration and auto-loader.

2.1.5.6. Primary tube sampling.

2.1.5.7. Vendor shall provide information on the size (i.e. volume) for each reagent container. Vendor shall provide the approximate number of tests that can be completed per each reagent container.

Meets the minimum requirement described in Section 2.1.5 above (y/n)?

Describe how the minimum requirement is met or exceeded:

File name of Contractor’s attachment, if providing additional supporting documentation:

2.1.6. Interface Requirements

2.1.6.1. The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system.

2.1.6.2. The Contractor shall provide any and all necessary software support for ensuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself.

2.1.6.3. The Contractor is responsible for everything leading up to the middleware including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system.

2.1.6.4. The vendor hardware and software proposed solution meets all VA Information Security, Hardware, Software and Network requirements (VA 6500). Any wireless equipment must be FIPS 140-2 compliant as well.

2.1.6.5. The Contractor supplies responses to required documents in order to add systems to the VA network including but not limited to the VA Form 6550, Access Control List (ACL) Communication Protocol, MSD2, and the Risk Analysis Tool.

2.1.6.6. If there are software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA Laboratory Interface Middleware.

2.1.6.7. If the Contractor shall provide remote support, the contractor has established a VA national MOU/ISA between Contractor and VA prior to award. If the Contractor currently has a valid MOU/ISA, the Contractor shall include a copy of the MOU/ISA as part of their quote with the file named “VA MOU/ISA”. The Contractor shall provide all hardware and software in order to implement the remote support system.

Technology must interface to VA licensed Data Innovations Instrument Manager sending all appropriate information in order to complete auto verification rules processing within the VA licensed IM. Preferred, but not required, that no additional middleware be necessary to connect instruments beyond the VA licensed DI IM.

Contractor shall collaborate with each lab to write/develop protocols to establish customer configurable rules to enhance workflow management and productivity.

When requested, the contractor shall help sites implement an auto verification script in VISTA from the VA licensed DI IM middleware rules package.

Meets the minimum requirement described in Section 2.1.6 above (y/n)?

Describe how the minimum requirement is met or exceeded:

File name of Contractor’s attachment, if providing additional supporting documentation:

2.2. STATEMENT OF WORK:

2.2.1. Method Performance/Validation Requirements

Method performance/comparison shall be at the expense of the Contractor, shall include linearity material and reagents, and be consistent with current CLSI guidelines.

Correlation studies for each analyte. A minimum of 40 samples spanning the reportable range shall be run by the present and the proposed method. In systems where multiple sampling modes exist, mode to mode correlation studies must also be performed. Contractor shall analyze results and provide statistical data to support acceptance of the new method for above studies. Statistics shall consist of at least mean, bias, CV slope, y-intercept, correlation coefficient, ROC analysis, and meet current standards defined by CLSI.

Analytical Measurement Range (AMR) Validation shall be performed on proposed instrument(s) for each analyte to validate the reportable range. The material must have values, which are near the low (4.5%) and high (18%) values of the AMR and be of appropriate matrix for the clinical specimens assayed by that method. A minimum 5-point linearity analysis that adheres to the Beer-Lambert Law and spans the entire range shall be performed as a minimum.

Precision study using normal and abnormal control material. This shall include, at a minimum, within run precision study of 10 normal and 10 abnormal controls. Intra-VISN facility variations should be kept at an absolute minimum.

Sensitivity. Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rate and false negative rate are applied.

Specificity Studies. A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances.

Carryover Studies. Successful carryover studies shall be completed by the contractor on all analyzers during installation. These studies shall be performed using either contractor developed program(s) or program(s) developed by a third party (CAP/CLSI). The programs shall be provided to each laboratory at no charge.

2.2.2. Reports - The Contractor shall provide to the Contracting Officer and other individuals (designated post-award) a copy of a quarterly report of sales, by ordering facility, within 30 calendar days after the close of each quarter’s business. Reports are to reflect, at a minimum, total net sales amounts before discount, and discount amounts by ordering facility as well as the raw data used to develop these reports. These reports shall be used to monitor the commitment of each facility, reporting the savings realized and shall be shared with each participating facility, personnel associated with acquiring the products, and respective laboratory personnel. Additional invoice charges associated with reagent and/or supply wastage, or repair parts included at no charge (per FSS awarded contract) shall not be accepted. There will be no additional charges for any reports required as part of the contract.

2.2.3. Support Features

Commercial marketing - The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

Start-Up Reagents - The Contractor shall provide all reagents, calibrators, controls, consumable/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, 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 at no cost to the Government. The Contractor shall perform all of the statistical analysis as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format.

Training - The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services and minimally equivalent to the terms and conditions for training defined in the Contractor’s Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers contract. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally two operators per facility at inception and one per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant.

Equipment Preventative Maintenance/Repair Service - The Contractor shall be able to provide equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support equipment (e.g. UPS, water system, and printers) offered according to the following terms:

Service Requirements

2.2.3.1.1.1. A technical assistance center shall be available by telephone 24 hours per day, 7 days per week.

2.2.3.1.1.2. Full repair service on all equipment, including ancillary equipment, shall be provided Monday through Friday from 07:00AM to 07:00PM. Inspection/assessment/troubleshoot response time (in person or phone consultation) by assigned Field Service Engineer (FSE) shall be no more than 4 hours of initial notification of the issue to the contractor. Delivery of parts and equipment to fix instrumentation (if required) must be within 24 hours of initial notification of the issue to the contractor to prevent excessive downtime at the cost of the contractor. Onsite repair service is to be provided within 2 business days of initial notification of the issue to the contractor.

2.2.3.1.1.3. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours as stated above. If all analyzers are down at a given station, service converts to 24/7 onsite repair service to maintain all operations. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel. Onsite repair service is to be provided within 4 hours of initial notification. Delivery of parts and equipment to fix instrumentation must be within 24 hours to prevent excessive downtime at the cost of the contractor.

2.2.3.1.1.4. Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and no later than 2 weeks after the scheduled due date. Contractor shall perform more frequent preventative maintenance if instrument performance indicates that more frequent maintenance is necessary.

2.2.3.1.1.5. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following:

2.2.3.1.1.5.1. date and time notified

2.2.3.1.1.5.2. date and time of arrival

2.2.3.1.1.5.3. serial number, type and model number of equipment

2.2.3.1.1.5.4. time spent for repair, and

2.2.3.1.1.5.5. proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

2.2.3.1.2. Each notification for an emergency repair service call shall be treated as a separate and new service call.

Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of –the art technology, at no additional charge to the Government. These 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, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, need for upgraded OS on desktop for computer security, etc. This does not refer to replacing the original piece of equipment provided under the contract; however, it does refer to significant changes in the hardware operational capability.

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

Interface Requirements

2.2.3.1.3. The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system (see Attachment A).

2.2.3.1.4. The Contractor shall provide any and all necessary software support for ensuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of interfacing equipment is supplied in Attachment A.

2.2.3.1.5. If a site already has a universal interface box, the Contractor is responsible for everything leading up to the box including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system.

2.2.3.1.6. If a site does not have a universal interface and one is needed to optimally interface the instrument, then the Contractor is responsible for the acquisition of the universal interface box and everything else needed to connect with VA computerized hospital information system.

2.2.3.1.7. If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system.

2.2.3.1.8. The Contractor shall provide remote support which will require establishment of a VA national MOU/ISA between Contractor and VA prior to award. If the Contractor current has a valid MOU/ISA, the Contractor shall include a copy of the MOU/ISA as part of their quote with the file named “VA MOU/ISA”.

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

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. Documentation shall be submitted as an attachment to the Contractor’s quote and the file shall be named “Characterization of Waste – Section 2.2.3.9”.

2.2.3.1.9. The determination and description shall address the following:

2.2.3.1.9.1. Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

2.2.3.1.9.2. Waste ignitability (Reference 40 CFR §261.21)

2.2.3.1.9.3. Waste corrosivity (Reference 40 CFR §261.22)

2.2.3.1.9.4. Waste reactivity (Reference 40 CFR §261.23)

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

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

2.2.3.1.9.7. Solid Waste (Reference 40 CFR §261.2)

2.2.3.1.9.8. Exclusions (Reference 40 CFR §261.4)

The Contractor will provide written instructions and training material to ensure VHA laboratory staff 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 shall fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

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, corrosivity, reactivity and toxicity as defined in 40 CFR §261 shall be determined and documented. Any mercury containing reagents shall be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerosal and formaldehyde) shall be developed and SDS sheets shall 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 shall be included with Contractor response:

2.2.3.1.23. pH

2.2.3.1.24. Flash point (to higher than 200°F)

2.2.3.1.25. BOD; biochemical oxygen demand

The documentation the Contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system. Documentation shall be submitted as an attachment to the Contractor’s quote and the file shall be named “Description of Waste – Section 2.2.3.12” Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after the award of the contract. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 90-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

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

Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 90 days for the transition of all services under the awarded contract including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate contract for cause under the Termination for Cause clause of the contract.

At the end of 90 days from award of the contract, the awarded Contractor shall have full and sole responsibility for services under the awarded contract.

2.2.4. Standard and Quality of Performance - This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order or contract is accepted by the Government. This also includes replacement, 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 30 consecutive calendar days by operating in conformance with the Contractor’s technical specification or as quoted in any contract at an effectiveness level of 90% or more.

2.2.4.1. In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days.

2.2.4.2. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled “Termination for cause.” (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.)

2.2.4.3. 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.

2.2.4.4. 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.

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

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

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

2.2.6. Ownership of Equipment - Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer.

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

2.2.8. Prior to termination or completion of this contract, Contractor/subcontractor shall not destroy information received from VA, or gathered/created by the Contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor shall 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 shall be sent to the VA Contracting Officer within 30 days of termination or completion of the contract.

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

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

2.2.10.1. Contractor shall accept the system without the drive;

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

2.2.10.3. VA shall reimburse the company for media at a reasonable open market replacement cost at time of purchase.

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

2.2.11.1. The equipment Contractor shall have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and

2.2.11.2. Any fixed hard drive on the device shall 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/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.

2.2.11.3. 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.