SOW_Capillary Analyzer.docx

STATEMENT OF WORK

Automated Capillary Serum and Urine Electrophoresis Analyzer System

1. Language:

1.1. Intent: It is the intent of the Veterans Service Integrated Network (VISN) 8 VA Sunshine Healthcare Network, Network Contracting Office (NCO) 8 to establish a long-term, base option plus four (4) option years Cost Per Test agreement (CPT) for Automated Capillary Serum and Urine Electrophoresis Analyzer System to support continued in-house testing service. The Government will award a Cost per Test (CPT) contract to a single Contractor for Automated Capillary Serum and Urine Electrophoresis Instrumentation, Reagents, Consumables, Equipment Service and Maintenance.

1.2. Background: The long-term agreement for the Automated Capillary Serum and Urine Electrophoresis Analyzer System will support the following locations in the VA Sunshine Healthcare Network to include Tampa, Orlando, West Palm Beach, Miami and San Juan, PR. All five locations will require automated capillary serum and urine electrophoresis instruments, reagents, consumables, equipment services and maintenance.

1.3. Definitions:

1.3.1. Cost per Test (CPT) as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost- Per-Test Clinical Laboratory Analyzers – Contractors are required to provide a price for each test that can be performed on its equipment. The price per test shall include costs covering of equipment use, (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) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel. Contractors are required to provide delivery, installation, and removal of equipment at no additional charge.

1.3.2. 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 receives, uses, or discloses VHA PHI to perform some activity for VHA. These BAAs obligate the VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule.

1.4. Test Menu and Estimated Annual Volumes per facility:

1.5. Facility - Will refer to the following facilities:

1.5.1. James A. Haley Veterans Hospital, located at 13000 Bruce B. Downs Boulevard, Tampa, FL 33612-4745. Station: 673

1.5.2. Orlando VA Healthcare System, located at 13800 Veterans Way, Orlando, FL 32827. Station: 675

1.5.3. Bruce W. Carter Miami VA Medical Center, located at 1201 Northwest 16th Street, Miami, FL 33125-1624. Station: 546

1.5.4. VA Caribbean Healthcare System, located at 10 Casia Street, San Juan, PR 00921 Station:672

1.5.5. West Palm Beach VA Medical Center, 7305 North Military Trail, West Palm Beach FL 33410 Station: 548

1.6. Acronyms:

1.6.1. VA: Veterans Affairs

1.6.2. VACHS: VA Caribbean Healthcare System

1.6.3. VAMC: VA Medical Center

1.6.4. P&LMS: Pathology and Laboratory Medicine Service

1.6.5. VHA: Veterans Health Administration

1.6.6. CAP: College of American Pathologist

1.6.7. TJC: The Joint Commission

1.6.8. SPEP: Serum Protein Electrophoresis

1.6.9. UPEP: Urine Protein Electrophoresis

1.6.10. IFE: Immunofixation

1.6.11. IT: Immunotyping

1.7. Contractor Requirements

1.7.1. Technical Requirements/Tasks: The Contractor shall provide Automated Capillary Serum and Urine Electrophoresis Instrumentations and Reagents, Consumables, Equipment Service and Maintenance to the five locations listed below:

1.7.1.1. James A. Haley Veterans Hospital, located at 13000 Bruce B. Downs Boulevard, Tampa, FL 33612-4745. Station: 673

1.7.1.2. Orlando VA Healthcare System, located at 13800 Veterans Way, Orlando, FL 32827. Station: 675

1.7.1.3. Bruce W. Carter Miami VA Medical Center, located at 1201 Northwest 16th Street, Miami, FL 33125-1624. Station: 546

1.7.1.4. VA Caribbean Healthcare System, located at 10 Casia Street, San Juan, PR 00921 Station:672

1.7.1.5. West Palm Beach VA Medical Center, 7305 North Military Trail, West Palm Beach FL 33410 Station: 548

1.7.2. 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 positive sample identification and random-access capability and can 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).

1.7.3. 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 technical specifications of this solicitation. Those additional analyzer(s) offered meeting the definition of a primary analyzer may serve as a back-up analyzer (see definition below) and shall replace the requirement for offering that category of equipment.

1.7.4. Summary Of Salient Characteristics:

1.7.4.1. Menu Test Parameter: Serum Protein Electrophoresis, Urine Electrophoresis and Serum / Urine Immunotyping

1.7.4.2. Measurement Methodology: Fully Automated walk-away Capillary Electrophoretic Separation Technology

1.7.4.3. Eight liquid flow silica capillaries.

1.7.4.4. Ability to run up to seven test parameters with automated changes between test types.

1.7.4.5. Throughput: up to 120 samples at a time

1.7.4.6. Direct sampling from primary tubes.

1.7.4.7. Results: Up to 79 results per hour (serum), 70 results per hour (urine) and 9 immunotyping (serum and urine) results per hour

1.7.4.8. Results software capable of graphing patient results

1.7.4.9. Reagents and Consumables: up to 4 flexible positions and ability to reload reagents without interrupting testing

1.7.4.10. Automatic delimiting of curves and identification of fractions.

1.7.4.11. Comprehensive Quality Control (QC) program with two Q.C. Levels including Levey-Jennings charts.

1.7.4.12. Communications: Bidirectional LIS connectivity with host query through laboratory middleware software.

1.7.4.13. Internal bar code reader

1.7.4.14. Approximate Platform Dimensions: Physical Characteristics include NTE 166lbs, and 34.5” (W) x 22” (H) x 27” (D) complete benchtop analyzer for all five facilities.

1.7.4.15. Equipment on-site service/ repairs included in contract

1.7.4.16. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of the laboratory. Equipment must maintain or, preferably, reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory. The equipment must streamline all aspects of testing, thereby enhancing operational efficiency, improving turnaround times, supporting improved patient outcomes, improving patient and provider satisfaction, and improving the productivity of the facility.

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

1.7.4.18. Contractor shall provide quality control material at a minimum of two levels, normal and abnormal levels, for each analyzer or per the requirements of each facility.

1.8. Task Requirements:

1.8.1. Equipment shall be acquired for each of the clinical laboratories located at the five facilities referenced in section 1.5 of this statement of work (SOW).

1.8.2. The Contractor is required to provide 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. 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.

1.8.3. Special handling for emergency orders of supplies: If supplies are found to be defective and unsuitable for use with the Contractor’s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 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 regularly scheduled standing order/routine supplies delivery.

1.9. DELIVERABLES/SCHEDULE:

1.9.1. Operational and Technical Features- The instrumentation offered shall be approved by the Food and Drug Administration (FDA) and be available on the Contractor’s FSS Contract at the time of proposal submission and have the following:

1.9.1.1. The capability and throughput to meet the volume and service demands as defined in Attachment A.

1.9.1.2. A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

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

1.9.1.4. Equipment must accept, at a minimum, 10 characters in specimen identifier that is alphanumeric that may be enabled concurrently.

1.9.1.5. A barcode reading accuracy rate of 99% or greater.

1.9.1.6. Analyzer must function using an operating system that is approved to connect to the VA computer systems. Technical Reference Model (TRM) approved.

1.9.1.7. Access Control List (ACL) Communication Profile

1.9.1.8. Quality Control (QC) data management system and includes Levy-Jennings graphs. Analyzer must have the ability to capture & store QC data.

1.9.1.9. Capability to detect and alert operator of out-of-range quality control results via flagged results on QC printout and visual alerts on display monitor.

1.9.1.10. Ability to participate in peer data management system for quality control results.

1.9.1.11. On board reagent inventory management, must have:

1.9.1.11.1. A system that provides reagent data to include but not limited to lot number and expiration date of reagents and quality control.

1.9.1.11.2. RFID identification of all reagents (reagent type, lot number, expiration date, volume).

1.9.1.11.3. On board reagent stability, sufficient to accommodate both high and low volume use.

1.9.1.12. Direct sampling from primary tubes.

1.9.1.13. The ability to continuously load patient specimens.

1.9.2. Hardware Features – The instrument shall have the following:

1.9.2.1. All monitors/screens will clearly display information in all light conditions.

1.9.2.2. 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)

1.9.2.3. Serial RS232 DB9 port for LIS connection.

1.9.3. Method Performance/Validation Requirements

1.9.3.1. Method performance/comparison shall be at the expense of the Contractor, shall include linearity material and reagents, and be consistent with current CLSI guidelines and related documents, The Joint Commission regulations, College of American Pathologists (CAP) standards, and Federal regulations. All studies performed will be appropriate for the test menu of the respective laboratory to include serum, plasma, urine, and body fluids, as applicable. These validation requirements are applicable to all new testing analyzers.

1.9.3.2. Correlation studies for each analyte. A minimum of 20 samples spanning the reportable range, shall be run comparing 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, slope, y-intercept, correlation coefficient, ROC analysis, and meet current standards defined by CLSI.

1.9.3.3. 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, mid, and high values of the AMR and be of appropriate matrix for the clinical specimens assayed by that method. A 5-point linearity analysis that adheres to the Beer-Lambert Law and spans the entire range shall be performed as a minimum.

1.9.3.4. 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.

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

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

1.9.4. Reference Range – A reference range must be determined for each test following CLSI Guidelines. Samples used for the reference range study must be representative of the patient population being tested. One of the following protocols shall be used:

1.9.4.1. A verification of the manufacturer’s suggested reference range may be performed if the suggested range is based on a comparable population of test subjects. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 20 reference individuals shall be used to verify the manufacturer’s range. Any apparent outliers should be discarded, and new specimens obtained to provide a statistically valid verification.

1.9.4.2. If the suggested manufacturer’s range is not appropriate for the patient population, a reference range shall be established. Establishing a reference must follow CLSI guidelines. This requires a minimum of 120 reference individuals to be used to establish a reference range. The reference interval should be determined using the nonparametric method.

1.9.5. 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

1.10. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories required to establish instruments for operation for performance of acceptance testing. This applies to all equipment as well as additional or replacement equipment placed under the terms and conditions of this agreement. The Contractor shall perform/assist, 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 the statistical analysis as stated in the Method Performance/Validation section above and provide a hard copy of data in an organized, clearly comprehensible format.

1.11. Training. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally one operator per facility 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

1.11.1. In addition to the training above the following shall be provided:

1.11.1.1. Basic operator training shall be provided by Contractor on-site for all operators on all shifts, as applicable.

1.11.1.2. Advanced training shall be provided on instrument troubleshooting, advanced middleware rules writing, data analytics, report writing and customization.

1.12. Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide ONSITE emergency equipment repair and preventative maintenance on all primary and back-up instrumentation, primary processing automation line instrumentation and any incremental support/ancillary equipment, e.g., printers, etc. offered according to the following terms:

1.12.1. Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.

1.12.2. A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 2 hour(s).

1.12.3. Equipment repair ONSITE service (preferred) shall be provided during core business hours. See Attachment A, defining core business hours of each facility included in this solicitation. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.

1.12.4. Equipment repair response time shall be no more than 24 hours.

1.12.5. 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:

1.12.5.1. date and time notified

1.12.5.2. date and time of arrival

1.12.5.3. serial number, type, and model number of equipment

1.12.5.4. time spent for repair

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

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

1.13. Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software 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, etc. This does not refer to replacing the original piece of equipment provided under the agreement; however, it does refer to significant changes in the hardware operational capability.

1.14. Ancillary support equipment - The Contractor shall provide, install, and maintain through the life of the agreement, as indicated, all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g., printers and universal interface equipment, uninterruptible power supply, etc.

1.15. Interface Requirements – All equipment must have the ability to interface to the Laboratory’s Information System (LIS) VistA via middleware. The system must be compatible with bi-directional or host query interface and must be compatible with the laboratory middleware system. 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).

1.15.1. The Contractor shall provide 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.

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

1.15.3. 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.

1.16. 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.

1.17. Warranty Of Equipment: Government requirement for standard manufacturer industry warranty term. Government does not accept extended warranty, which requires advance payment.

1.18. Installation Procedures: The contractor shall be responsible for installation, which consists of in-house delivery, positioning, and mounting of all equipment listed on the delivery order and connections of all equipment and interconnecting wiring and cabling if applicable. Upon receipt of notice to proceed with installation, it shall be the contractor's responsibility to inform the Point of Contact at each location of any issues which may be anticipated in connection with installation, or which will affect optimum performance once installation is completed. In the event progress of the installation is interrupted through no fault of the contractor, the installation may be suspended until such time as the cause of delay has been eliminated. The Contractor shall resume the subject installation within 24 hours after the contractor has been notified.

1.19. 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.

1.20. Delivery Locations: Items ordered to ship FOB destination. Each order placed by each site/medical center will specify delivery address, items, and quantities needed. Also delivery orders issued shall be identified by their applicable FSS Contract Number and Purchase Order Number.

1.21. Implementation/Transition Timeframe: The implementation of the service and requirements described in this solicitation shall be completed no later than 90 days after the award of the agreement. This timeline is based on a reasonable attempt of the Contractor to complete all 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.

1.21.1. Upon award of an agreement the transition period for the awarded agreement 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.

1.21.2. Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed days for the transition of all services under the awarded agreement 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 agreement for cause under the Termination for Cause clause of the agreement.

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

1.22. 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 agreement] 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 proposal at an effectiveness level of 90% or more.

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

1.22.2. 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.)

1.22.3. 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 the period when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition.

1.22.4. 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 more than the minimum of 100 hours.

1.22.5. 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.

1.22.6. During the term of the agreement 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 Point of Contact (POC) and/or contracting officer 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. The same terms and conditions apply to ancillary/support equipment provided under this agreement, i.e., water system UPS, etc.

1.23. 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.

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

1.23.2. Prior to termination or completion of this agreement, Contractor must not destroy information received from VA, or gathered/created by the Contractor while performing this agreement without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor 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 30 days of termination or completion of the agreement.

1.23.3. 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 agreement 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/subcontractors that contain VA information must be retained by the VA for sanitization or destruction, or the Contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination or completion of the agreement or disposal or return of the IT equipment, whichever is earlier.

1.23.4. 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:

1.23.4.1. Contractor must accept the system without the drive.

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

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

1.23.4.4. 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

1.23.4.5. The equipment Contractor must 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

1.23.4.6. 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/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or agreement.

1.23.4.7. 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.

1.24 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 determine if the waste is a hazardous waste or otherwise regulated. The determination and description shall address the following:

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

1.24.2 Waste ignitability (Reference 40 CFR §261.21)

1.24.3 Waste corrosivity (Reference 40 CFR §261.22)

1.24.4 Waste reactivity (Reference 40 CFR §261.23)

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

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

1.24.7 Solid Waste (Reference 40 CFR §261.2)

1.24.8 Exclusions (Reference 40 CFR §261.4)

1.24.9 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 must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

1.24.10 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 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e., mercury, thimerosal, and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with vendor response:

1.24.10.14 pH

1.24.10.15 Flash point (to higher than 200°F)

1.24.10.16 BOD; biochemical oxygen demand

2.4 2.4.7 2.4.7.11 2.4.7.11.1

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

1.25Orders: All products ordered under this contract, placed against the Federal Supply Schedule Award Contract(s), are subject to the terms and conditions of the FSS contract. The Government is obligated only to the extent of authorized orders issued under this contract by authorized individuals.

1.26 Prices And Terms: Facilities will provide an estimated annual volume by test. Pricing is based on the AVERAGE annual test volumes per instrument/analyzer for each facility. The Government estimates the volumes per facility as listed in section 1.4 but does not guarantee volumes as listed; they are estimates ONLY. The agreement shall include all new facilities and/or outpatient clinics acquired into VISN 8 during the contract period. When additions occur, a bi-lateral contract modification will be executed.

1.27 Term Of Agreement: This will be a long-term single award, Cost per test (CPT) and shall be effective for the term of the FSS Contract including additional FSS extensions. The Contractor is required to immediately notify the CO (Government Contracting Officer), in writing, if at any time the FSS contract upon which this agreement is based, is no longer in force. The resulting agreement shall be automatically extended for the remaining term of the contract without modification upon any extensions of the Contractor’s FSS contract. In addition, where a new FSS contract replaces Contractor’s current FSS contract, the resulting agreement may be reassigned under the new FSS contract for the remaining term of the contract with written agreement between the Contractor and the contracting officer. This agreement is not a contract. If the Contractor fails to perform in a manner satisfactory to the CO, this agreement may be canceled with thirty (30) days written notice to the Contractor by the CO. The Contractor shall also reserve the right to terminate this contract with 30 days notification to the CO. This agreement shall be reviewed annually. VISN 8 intends to establish a long-term agreement for the period of 04/01/2026-03/31/2027.

1.28 Ordering Method: VISN 8 facilities may order products via telephone, facsimile, email, standing order or other written communication, identifying the products by number, quantity, purchase price, purchase order, address for delivery, and any special instructions.

James A. Haley Veterans Hospital, located at 13000 Bruce B. Downs Boulevard, Tampa, FL 33612-4745. Station: 673

Maribelis Vazquez Baez, Maribelis.VazquezBaez@va.gov

Orlando VA Healthcare System, located at 13800 Veterans Way, Orlando, FL 32827. Station: 675

Jeannette Spivey, Jeannette.Spivey@va.gov

Bruce W. Carter Miami VA Medical Center, located at 1201 Northwest 16th Street, Miami, FL 33125-1624. Station: 546

Vaishali Dave, Vaishali.Dave@va.gov

VA Caribbean Healthcare System, located at 10 Casia Street, San Juan, PR 00921 Station:672

Stephanie Garcia-Hernandez stephanie.garcia-hernandez@va.gov

West Palm Beach VA Medical Center, 7305 North Military Trail, West Palm Beach FL 33410 Station: 548

Eva E. Koci Eva.Koci@va.gov

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

Vendor, vendor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

3. VA INFORMATION CUSTODIAL LANGUAGE

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R.