This Sources Sought Notice is for planning purposes only and shall not be considered as an invitation for bid, request for quotation, request for proposal, or as an obligation on the part of the Government to acquire any products and/or services. Your response to this Sources Sought Notice will be treated as information only. No entitlement to payment of direct or indirect costs or charges by the Government will arise because of contractor submission of responses to this announcement or the Government use of such information. This request does not constitute a solicitation for proposals or the authority to enter negotiations to award a contract. No funds have been authorized, appropriated, or received for this effort. The information provided may be used by the Department of Veterans Affairs in developing its acquisition approach, statement of work/statement of objectives and performance specifications. Interested parties are responsible for adequately marking proprietary or competition sensitive information contained in their response. The Government does not intend to award a contract based on this Sources Sought Notice or to otherwise pay for the information submitted in response to this Sources Sought Notice. The submission of pricing, capabilities for planning purposes, and other market information is highly encouraged and allowed under this Sources Sought Notice in accordance with (IAW) FAR Part 15.201(e). The purpose of this Sources Sought Notice announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service-Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, 8(a), HubZone and other Small Businesses interested and capable of providing the products and/or services described below. Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. Responses to this notice shall include the following: (a) Company Name; (b) Address; (c) Point of Contact; (d) Phone, Fax, and Email; (e) UEI Number; (f) Cage Code; (g) Tax ID Number; (h) Type of Small Business, e.g., Services Disabled Veteran Owned Small Business, Veteran Owned Small business, 8(a), HUBZone, Women Owned Small Business, Small Disadvantaged Business, or Small Business HUBZone business, etc.; (i) State if your business has an FSS contract with GSA, VA NAC, NASA SEWP, or any other federal contract, that can be utilized to procure the requirement listed below and provide the contract number; and (j) Must provide a capability statement that addresses the organization s qualifications and ability to perform as a contractor for the work described below. Requirement: The VA Heartland Network 15 Contracting Office located at 3450 South 4th Street, Leavenworth, KS, 66048-5055 is seeking a potential qualified contractor to provide Cost Per Test (CPT) for Automated Microbiological Blood Culture Testing/Systems. The North American Industry Classification System Code (NAICS Code) is 334516 (Analytical Laboratory Instrument Manufacturing), size standard of 1000 employees. Based on this information, please indicate whether your company would be a Large or Small Business and have a socio-economic designation as a Small Business, VOSB or SDVOSB. Important Information: The Government is not obligated to, nor will it pay for or reimburse any costs associated with responding to this source sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to an acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Currently a total set-aside for Service-Disabled Veteran Owned Small Business firms is anticipated based on the Veterans Administration requirement with Public Law 109-461, Section 8127 Veterans Benefit Act. However, if response by Service-Disabled Veteran Owned Small Business firms proves inadequate, an alternate set-aside or full and open may be used. Responses to this notice shall be submitted via email to Maria Riza Owen at maria.owen2@va.gov. Telephone responses will not be accepted. Responses must be received no later than Friday, March 7, 2025, at 4:30pm CST. If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this sources sought. Responses to this source sought notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation. Notice to potential offerors: All offerors who provide goods or services to the United States Federal Government must be registered in the System for Award Management (SAM located on the web at www.sam.gov). Additionally, all Service-Disabled Veteran Owned Businesses or Veteran Owned Businesses who respond to a solicitation on this project must be registered with the SBA VetCert at https://veterans.certify.sba.gov/ VA Heartland Network- VISN 15 STATEMENT OF WORK Clinical Laboratory Microbiological Blood Culture System SCOPE OF PROCUREMENT: VISN 15 is looking to initiate a Cost Per Test (CPT) for Automated Microbiological Blood Culture testing/Systems. The CPT pricing would include the testing meters/equipment to support the needs of each facility. Kansas City VAMC Topeka VAMC Columbia VAMC St. Louis VAMC Marion VAMC Poplar Bluff VAMC Wichita VAMC Would like the capability to add, remove or alter; The estimated volume of tests needed at each facility, Add or remove reagents Upgrade instrumentation as new technology becomes available on the market. New equipment shall be acquired for each of the clinical laboratories located at the VISN facilities. The instrumentation shall have the capability of performing and reporting the clinical parameters as defined in this statement of requirements. The instrument shall 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). The Contractor will be required to provide a continuously stocked inventory of; Reagents Standards Controls Supplies Disposables 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. Any 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. 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 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. DEFINITIONS 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 per test price shall include costs covering (1) 4 year 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. Cost per Patient Reportable Result (CPRR)- 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 a reportable patient result. The per patient reportable result price shall include costs covering: (1) 5-year 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 of a patient reportable result. The per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required to produce a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI); (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 shall provide delivery, installation, and removal of equipment at no additional charge. 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 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. GENERAL REQUIREMENTS 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 the technical specifications of this solicitation. Vendor shall provide latest model/version of instrumentation Operational Features / Required Testing Protocols The system shall provide self-contained, continuous, computerized, automated monitoring of blood culture bottles with immediate, active (e.g. audible alarm) notification of microorganism growth based upon preprogrammed criteria and notification of termination of maximum programmed incubation period when no microorganism growth is detected. The system shall allow for operator extension of programmed incubation times, while testing is in progress, without interruption of automatic continuous monitoring. The data management system shall accept manual entry of organism identification and other additional microbiological information (i.e., gram stain and organism identification). A varied selection of blood culture bottle configurations (low volume samples; antimicrobial agent removal resins) and formulations capable of maximizing growth potential of various microorganisms (e.g., aerobic, and anaerobic bacteria, and fungi) shall be available. Sufficient capacity and throughput to meet the volume, blood culture bottle variety, and service demands. Capability to auto-verify negative cultures. Provide all materials required for validation including blood culture bottles, organisms, collection/transfer devices and sterile defibrinated horse blood. Blood culture bottles must be compatible for use with diversion devices. Ability for instrument to detect blood culture volume automatically. Ability for instrument to unload automatically. Ability to have a conveyor belt with auto load function. Ability to run automatic cell QC. 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. 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. The accuracy of the barcode reading must have less than a 1% failure rate. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. Equipment must accept, at a minimum, 10 characters in specimen identifier that is alphanumeric. An operational system that is automated and provides continuous unattended testing throughout the day for a minimum of five days. The system will be capable of processing inoculated bottles that have been incubated off line at room temperature for up to 12 hours. Minimal daily and periodic maintenance. The reading chambers must be modular in nature allowing for the isolation of a given problem without having to shut the entire system down. Analyzer utilizes windows operating software or another VA approved operating system. Vendor will complete and return the following attachments: 6550 Pre-Procurement Assessment MDS2 Manufacturer Disclosure Statement for Medical Device Security ACL Communication Profile Technical Features- The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following: Bar-Code System: The system shall support bar-code recognition of inoculated bottles for tracking of bottles at entry into the system and throughout incubation until such time as the incubation has finalized as positive or negative for growth. Data Management System: The capability to record, store and print the following information: blood culture bottle location length of incubation time to detection growth curve analysis of positive vials required quality control and instrument maintenance information patient demographic information and specimen results the fill volume of the blood culture bottle detailed epidemiology reports Shall be capable to connect and integrate results through a middleware system. Shall be capable of maintaining all data and if interfaced, retransmit data for up to 24 hours in the event of normal electrical power interruptions via battery backup. Shall have a built-in quality control program to regularly monitor performance of vital components. Shall possess capability to backup all data to a secondary external storage format (e.g. compact disk). Shall have sufficient memory to store patient information and test results for 10,000 records with downloading capability to an external medium for long term storage of patient records and other information. Blood Culture Bottles: Shall be easily distinguished (e.g. color coded) for utility or intended purpose. Shall be approved for culture of normally sterile body fluids other than blood. Shall be barcoded with unique identifiers for loading and system monitoring. Shall be formulated as not to require venting prior to incubation of aerobic bottles. Shall have expiration date clearly marked. The minimum acceptable expiration date will be no less than 9 months. The vendor must maintain and supply records for each lot of media produced and received by the laboratory, such as a certificate of conformance , which indicates that the QC was performed and meets the CLSI/NCCLS standard and checklist requirements listed in Standard M22-A3, Quality Control for Commercially Prepared Microbiological Culture Media. The media and incubation conditions shall have been validated for the detection and recovery of fastidious bacteria (such as N. meningitidis, S. pneumoniae, H. influenzae) and yeast. Specific Equipment Requirements Transparent Plastic Bottles are desirable for safety (glass bottle could break if dropped) and disposal cost savings (glass bottles weigh more). If special adapters are needed for direct blood draw into the collection bottles, cost of adapters must be included in price proposal. Shall be approved for culture of normally sterile body fluids other than blood. Shall be formulated as not to require venting prior to incubation of anaerobic bottles. Hardware Features The instrumentation shall have the following: A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. An on-board monitor/screen that is easily readable. A printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient s name and accession number or unique identifier number (UID). An uninterruptible power supply with line conditioner for each instrument provided, including replacement of batteries. Method Validation Requirements The Contractor shall assist each site in the performance all comparison and validation studies to include any materials and reagents needed for such correlation at no cost to the Government. The Contractor shall perform all statistical analysis, as applicable, and report data in an organized, clearly comprehensible format. This process shall be consistent with current CLSI Standards and related documents, CAP standards, and Federal Regulations. Implementation/transition timeframe Need validation of equipment completed validated 90 days before final award. Current contract expires on 07/31/2025. The implementation of the services/requirements described in this solicitation shall be completed no later than 120 days after award. 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 120-day timeframe if the extension is through no fault of the Contractor and is a result of delays due to the Government. Upon award the transition period for the awarded BPA to have all equipment and peripherals installed and operational by August 1, 2025. 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 project for the transition of all services under the awarded BPA including installation and training of personnel, transition of all testing materials, reagents, and supplies, etc., performance of all correlations and validations with a start date of 08/01/2025. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate BPA for cause under the Termination for Cause clause of the BPA. Equipment relocation: In the event of moving the new equipment to a new location (such as a new laboratory), the contractor shall move contracted lab equipment from the current location to the new lab space. 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 assist the Government with validation and method comparison studies. All materials and reagents needed for such correlation at no cost to the Government. The Contractor shall perform all the statistical analysis and report data in an organized, clearly comprehensible format. This process shall be completed within two weeks of installation of the analyzer at each site and shall be consistent with current CLSI and related documents, CAP Standards and Federal Regulations. Training Upon Installation: The Contractor shall provide advanced (key operator) instrument training program for at least three operators per facility at no charge to the Government that is coordinated with and timely with 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 troubleshooting 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. Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary instrumentation and any incremental support equipment, e.g. water system, offered according to the following terms: Service Requirements 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 1 hours. Equipment repair service shall be provided during core business hours. 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. Equipment repair response time shall be no more than 24 hours. Preventative maintenance will be performed as frequently as published in manufacturer s operator s manual and within 2 weeks of the scheduled due date. 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: date and time notified date and time of arrival serial number, type and model number of equipment time spent for repair, and proof of repair that includes documentation of a sample run of quality control verifying acceptable performance. 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 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 BPA; 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 BPA , as indicated, all ancillary support equipment to fully operate or place the analyzer within a laboratory as defined in these specifications, e.g. cabinetry to support/house the analyzer, 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, line conditioners, UPS, and UPS batteries, etc. Interface Requirements 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. Shall be capable to connect and integrate results through a middleware system Work with the Laboratory Information Managers to interface the middleware system with vendor provided instruments. Provide remote or onsite guidance on validation techniques and assist troubleshooting. The Contractor shall provide all necessary software support 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. 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. 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. 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. Vendor must supply the following documentation for all analyzers and data management systems proposed to VISN 15: MDS2 - Manufacturer Disclosure Statement for Medical Device Security. VA Directive 6550 Appendix A- Pre-Procurement Assessment ACL Communication Profile 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. The determination and description shall address the following: Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24) Waste ignitability (Reference 40 CFR §261.21) Waste corrosivity (Reference 40 CFR §261.22) Waste reactivity (Reference 40 CFR §261.23) Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31) Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33) Solid Waste (Reference 40 CFR §261.2) 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 must 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 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, thimerosol 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: Barium (Total) Cadmium (Total) Chromium (Total) Copper (Total) Cyanide (Total) Lead (Total) Mercury (Total) Nickel (Total) Silver (Total) Zinc (Total) Arsenic (Total) Selenium (Total) Tin (Total) pH Flash point (to higher than 200F) 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. 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 BPA] 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 BPA at an effectiveness level of 90% or more. 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. 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.) 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. 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. 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. During the term of the 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 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 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. Prior to termination or completion of this BPA, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this BPA 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 BPA. 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 BPA or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the Contractor/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 BPA or disposal or return of the IT equipment, whichever is earlier. 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: Contractor must accept the system without the drive; 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 VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. 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; 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; 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 BPA. 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.
