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 Service for Automated Glycophemoglobin Instrumentation for VISN 15 VAMC s. Please see the Performance Statement of Work for more specifics and details. The North American Industry Classification System Code (NAICS Code) is 334516 (Analytical Laboratory Instrument Manufacturing), size standard 1,000. 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 Lisa Buchanan at lisa.buchanan1@va.gov. Telephone responses will not be accepted. Responses must be received no later than Monday, October 21, 2024, at 8:00AM CST. Please reference 36C25525Q0020 in the subject line. Please provide your Unique Entity ID so that your organization can be identified in SAM.GOV. Only organizations with an active SAM.GOV account can be considered. 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 source 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. Automated Glycohemoglobin Instrumentation SCOPE OF PROCUREMENT: It is the intent of VISN 15 to award a new contract for Automated A1c. The Government will award a CPRR/CPT agreement to a single contractor for Automated Glycohemoglobin Instrumentation. 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) and 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). Additional facilities within VISN 15 may be added or deleted at no cost to the government. Tests/reagents/instrumentation may be added to the agreement as new technology becomes available on the market. VISN 15 intends to establish the base year of the agreement for the period of 06/01/2025 through 05/31/2026. Equipment must maintain, or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory. Award is needed in June; requirement delivery is needed two (2) months prior to expiration of current contract to allow for delivery, installation, training, and completion of validation studies required by laboratory standards. If Contractor offers a family of analyzers, VISN 15 technical evaluation panel will determine if instrumentation proposed meets needs of using facility. Equipment shall be acquired for each of the clinical laboratories located at the VISN facilities listed in Attachment A. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables, and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration dates must be clearly marked on reagent, standard, and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor. 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. Estimated volumes of reagents can be found in Attachment A. DEFINITIONS: Cost per Patient Reportable Result (CPRR)- 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 items required for the proper operation of the Contractor s equipment and necessary for the generation of a patient reportable result. This 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 of the technical specifications of this solicitation. Those additional analyzer(s) offered meeting the definition of a primary analyzer shall be equivalent to a back-up analyzer (see definition below) and shall replace the requirement for offering that category of equipment. The system must be certified by the National Glycohemoglobin Standardization Program (NGSP), 2024 Standard of Medical Care in Diabetes. The A1C test should be performed using a method that is standardized or traceable to the Diabetes Control and Complications Trial Reference Method, 2024 List of NGSP Certified Methods. Coefficient of Variation (CV) must be less than 2.5%. The instrument must be FDA for primary diagnosis of Diabetes Mellitus. Operational Features -The instrumentation offered shall have the following: The capability of performing analysis on 100% of the tests listed in Attachment A. Sufficient capacity and throughput to meet the volume and service demands as defined in Attachment A. 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, BCBC characters in specimen identifier that is alpha and/or numeric depending on site. Minimal daily, monthly, and periodic maintenance. Instruments with minimal maintenance will be prioritized. Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage. 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. No requirements for sample pre-treatment. A specimen handling/loading system: Primary specimen container(s) loaded into a storage area, e.g., tray, rack, wheel, etc. for automated processing. Diluting and injecting of the specimen is handled with minimal operator intervention. Ability to accept various types of sample containers. Technical Features- The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following: Technology for measuring A1C should be either HPLC (high-performance liquid chromatography or Capillary separation). Complete separation of the labile and stabile hemoglobin A1C. Methodology that provides minimal interference from common hemoglobin (Hb) variants. Methodology must have the ability to detect the presence of variant hemoglobins. Method must have no interference from Hgb F up to 30%. Instrument must have redundant reagents and ability to replace without stopping the instrument. On Board reagent inventory system. Instrument must be able to track reagent lots, expiration dates and volumes automatically. Instrument software must have the ability to review chromatography and allow for auto validation of results. Instrument must have the ability to repeat samples automatically that are flagged by the review software. Internal ability to assess column and detector functionality over time. A method for the determination of column and detector integrity must be provided. Mechanism available to handle testing of micro-samples of blood. On-board QC data management system with a minimum storage capacity four (4) QC files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data. Capability to detect out of range quality control. Systems with QAP programs will be prioritized. Ability to monitor instrument performance. Capability of dispensing samples and reagents with minimal carryover. Long calibration stability- vendors with the longest stability will be prioritized. Controls for primary use (assayed) will be provided. Linearity materials which are required every six (6) months for all analytes due to a CAP requirement for maintaining assays and CLSI method validation to be provided by the Contractor. 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. Please see space restrictions below: Equipment shall not exceed (W in X H in X D in) SITE Width (in) Height (in) Depth (in) Columbia  90 30 22 Kansas City  92 36 30 Leavenworth No restriction No restriction 31 Marion 70 No restriction 29 Evansville  No restriction No restriction 30 Poplar Bluff  50 29 29 St. Louis 40 36 26 Topeka  No restriction  No restriction  28 Wichita  73 18  29 Cape Girardeau 40 30 28 Jefferson Barracks 36 No restriction 26 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 or unique identifier number (UID). An uninterruptible power supply (UPS) with line conditioner for each instrument provided. An auto sampling system that includes cap piercing closed tube aspiration, and auto-loader. Primary tube sampling. Method Performance/Validation Requirements Method performance/comparison shall be completed by and at the expense of the Contractor, shall include linearity material and reagents, and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards and Federal regulations. 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, 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, mid, and high 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 studies using normal and abnormal control material. This shall consist of a within-run precision study of 10 normal and 10 abnormal controls and a day-to-day precision study of normal controls and abnormal controls for 10 days (maybe run twice a day) for a total of 20 values per level of control. 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 interrupting 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. 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. Reference range assessment must be performed for each lab. One of the following protocols shall be used: A verification of the manufacturer s suggested reference range may be performed as long as 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. 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. If a laboratory is currently using the proposed instrument/reagent system, the in-use reference range can be transferred to the new system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, one of the two above items must be performed. Other Requirements: 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. Support Features-The equipment models being offered shall be in current production as of the date this offer is submitted. 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. 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. 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 online procedure manual in the instrument software. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item required to establish instruments for operation for performance of acceptance testing. The Contractor shall perform, to the satisfaction of the Government, all validation studies including precision, method comparison with current analyzer, accuracy (recovery), 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. Upon Installation: The Contractor shall provide advanced (key operator) instrument training program for at least two 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. 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. Service Requirements- Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up 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 hour. Equipment repair service 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. 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. 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. Upgrades - The Contractor shall provide upgrades to the equipment hardware, bidirectional interface 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 if sites are interested. 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 the software, correction of a hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace the 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. Ancillary support equipment The Contractor shall provide, install and maintain through the life of the agreement, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. universal interface equipment. 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, 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 (see Attachment A). Cerner Compatibility Statement Vendors providing a bid to this requirement shall provide a Cerner Compatibility Statement (CCS)from the OEM of the equipment. The CCS must include the following: An OEM attestation that the product proposed is Cerner verified. The statement must be dated within 60 days of the quote to ensure it is recent and accurate. A list of VA healthcare organizations that have deployed the device/system with the Cerner EHR. Details related to any data to be transmitted to Cerner. The statement must provide an OEM point of contact for questions or concerns related to Cerner compatibility. The proposal must declare if the device/system does not connect to the network or electronic medical record. Vendor bids that do not include a CCS directly from the OEM will be disqualified. All devices running windows must be Windows 10 OS at the time of award. The vendor shall provide assistance with setting up Autoverification through Data Innovations Work with the Laboratory LIMs to interface VISTA LIS with vendor provided instruments Provide remote or onsite guidance on validation techniques and assist troubleshooting Provide support and guidance during modifications of final Autoverification build. For example, modifying rules logic cutoff based on evolving SOP s. 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. 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. Contractor shall provide copies of current ISA/MOU and BAA with the VA that are applicable for remote connection to the interface system used to manage the testing system. 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 200 F) 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. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after the award. 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, the transition period for the awarded agreement to have all equipment and peripherals installed and operational shall be from the 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 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. At the end of 90 days from award of the agreement, the awarded Contractor shall have full and sole responsibility for services under the awarded agreement. 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 agreement 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. 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 agreement, 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. 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. 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. 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 agreement, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of 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. 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/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 agreement 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 agreement. 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.
