Attachment B Hematology SOW 9_2_22 final.docx

1. STATEMENT OF WORK

0. Introduction and Scope of Required Specifications:

The contractor shall provide hematology testing equipment that meets all the following requirements:

0. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined herein for all hematology related testing. The instrument shall be capable of automation, and reflex testing to automated slide maker stainer (SMS). The instrument shall be capable to simultaneously perform the complete profile as described below meeting 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 shall identify if their test and specimen types are FDA approved.

0. Equipment: All equipment delivered to the participating medical centers and CBOCs shall be new, state of the art, and not recertified nor refurbished.

0. Industry Standards: Unless otherwise stated, all equipment shall be held to current industry standards for such equipment is present in the current marketplace for Clinical Hematology equipment, supplies and related services.

0. Contractor must follow all applicable state, federal and local laws, and regulations related to laboratory testing.

0. General Requirements

1. Clinical Laboratory Hematology Analyzer – Automated system for the robotic specimen handling and accurate analysis, data review, and reporting of human hematology test results. The analyzer offered by the contractor shall fully support the estimated annual site volume listed on the schedule. The automation line shall have option for mirrored analyzers and SMS.

1. Consumables and Reagents Definition: Contractor shall provide all supplies, reagents, consumables required for the installation/validation of the analyzer system. This requirement includes all reagents, calibrators, controls for the CBC analyzer and SMS. This requirement includes consumable hardware such as needles, probes, syringe tips, automated pipette tips and supplies. This requirement includes printer ribbons for specialty printers such as SMS slide printers, buffers, stain, diluents, and cleaners. This requirement includes supplies for ancillary equipment such as water system filters, membranes and polishers, air filters, light bulbs, specialty barcode labels.

1. Complete Blood Count (CBC), White Blood Cell (WBC), Automated Differential (DIFF) and reticulocyte: CBC with a minimum 5-part differential shall include the following parameters at a minimum: hemoglobin, hematocrit, WBC, RBC, platelet, MCH, MCV, MCHC, RDW, MPV, and reticulocyte. 5-part WBC differential shall include at a minimum: Percent and absolute counts for the following parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils.

1. Complete Blood Count (CBC), White Blood Cell (WBC), Automated Differential (DIFF): On body fluids shall include the following parameters at a minimum: WBC, RBC, Total Neutrophil Count. 2-part WBC differential shall include at minimum: Percent and absolute counts for the following parameters: Polymorphonuclear Leukocytes and Mononuclear Leukocytes.

0. Instrumentation Requirements:

2. Analyzer(s) –Contractor shall provide Clinical Hematology analyzers that meet the following requirements:

0. The Contractor shall provide a Clinical Hematology analyzer capable of performing the test descriptions listed on the schedule.

0. Sufficient capacity and throughput to meet the estimated annual site volume. Facilities shall receive equipment capable of no less than 80 samples per hour except for CBOCs. CBOCs will receive equipment capable of no less than 20 samples per hour.

0. An auto sampling system that includes cap piercing closed tube aspiration, auto-loader, auto-mixing with a minimal capacity of [100] samples.

0. The ability to continuously load patient samples.

0. The ability to detect and alert operator of low reagent and consumable levels.

0. Data Storage patient sample results, including scattergrams, and the ability to export results to external storage media for acceptable review by regulatory agencies.

0. On-board quality control (QC) data management system which includes Levy- Jennings graphs and Gaussian statistical analysis. The analyzer must have the ability to transfer QC data to external media. The contractor must provide a quality assurance program that allows performance comparison to other labs running the same equipment. This should be accessible by direct interface or internet download.

0. Effective Clot detection to avoid instrument malfunction and inaccurate analysis.

0. Shall provide the ability to run in automated closed tube and manual open tube modes.

0. Capability to provide sensitive and specific evaluation of WBC, RBC, and PLT populations that identifies normal and abnormal cell populations. Alternate platelet counting methods for accurate counts when RBC interference is flagged is preferred. This capability shall include flagging criteria (or any other suitable method) for scans and manual differential requirements, including decision rules which shall be in the control of trained laboratory staff. Access to this capability shall be provided in the analyzer’s data manager or equivalent solution which shall enable rules for slide making, sorting of specimens for off-line and reflex testing.

0. Calibrations are to be stable per minimum CAP specifications and the procedure for performing calibrations must not be labor intensive.

0. Ability to analyze multiple different sources of body fluids. Vendor will supply list of body fluids the system has been approved to analyze.

2. Other Primary Hardware Features: Contractor shall provide Clinical Hematology equipment that meets the following requirements:

1. Analyzer with automation features for all medical centers excluding CBOCs. The contractor shall also provide a middleware and/or data manager software package as necessary to function as an integrated line.

1. The contractor shall provide a Cellavision or equivalent digital slide review system that integrates with the contractor’s middleware or with the existing middleware (Data Innovations) or with the LIS. Immersion oil for the digital slide review system included.

1. The contractor shall provide a laboratory grade bench or instrument cart if the install of the instrument is not freestanding.

1. Provide a digital and hard copy of the operations manual for all equipment provided.

1. Slide maker Stainer System (SMS) shall have the capability to produce labeled blood film preparations and staining. The system shall have the capability to identify and aspirate samples. The SMS will have the capability to stain manually prepared slides. Mechanism or software shall automate slide making and staining for all required manual differentials as defined by the approved data management rules. Minimal daily maintenance and associated downtime is preferred.

2. Barcoding – Contractor shall provide barcoding stations located at user monitoring stations along the line or track system and must have the following capabilities:

2. The accuracy of the barcode reading must have less than a 1.0 % failure rate.

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

2. Bar coding of reagents and the ability to track reagent containers throughout the testing process using bar code technology.

2. Track reagent inventory by bar code or radio-frequency identification (RFID).

2. Equipment shall accept, at minimum, 10 characters in specimen identifier that is alpha and/or numeric.

2. Printers and Other Support Items (Support Items): Contractor shall provide printer and other support equipment that meets the following requirements:

3. Printers that have the capability of printing a patient report with patient demographic information that includes the patient’s name, medical record number (SSN) and accession or unique identifier number (UID).

3. An uninterruptible power supply (UPS) with line conditioner for each instrument provided. (This includes UPS units for sites with automation lines, specimen management systems, data management systems, refrigerated storage, etc,) Each UPS must provide electrical power for a minimum of 15 minutes after electrical power fails and the system must allow for an automatic controlled shutdown to prevent damage to the instrument and data records.

0. Software, Connectivity and Conformance Standards: The instrument software shall have capability to connect to other equipment and software systems that meet the following requirements:

3. Instrument Software – Internal testing instrumentation software that provides/maintains the following:

0. Ability to monitor instrument performance.

0. Continuous monitoring of vital functions with immediate operator notification of failure(s) and on-board storage of these records.

0. 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.

0. Ability to store and retransmit patient records to the VA Laboratory Information system for a minimum 72 hours in case of interface outage.

0. Capability to record, store and print the following information:

4. Quality control, calibration, and instrument maintenance information.

4. Patient demographic information and specimen results.

0. The capability to program a test as a repeat with interfacing of results to overlay initial result.

0. Ability to retransmit patient records to the Laboratory Information System (including contractor provided middleware) in case of interface outage.

3. Customization

1. Contractor shall provide equipment with technology to automatically repeat testing based on customer configurable testing criteria (repeat testing).

1. Contractor shall provide equipment with technology to automatically direct additional specimen testing based on customer-configurable testing criteria (reflex technology).

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

1. Contractor shall provide auto verification workflows and/or an auto verification rules library to be used during setup. The contractor shall provide education to key personnel on how to maintain functionality of these operations. Contractor shall provide education that includes middleware training for standard operations and rules writing.

3. Interface

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

2. The Contractor shall provide all system configuration options and diagrams for any hardware and/or software, with annotation of whether contractor provided, or VA provided, required for the connection, implementation, and operation of the interface to the VA licensed Data Innovations Instrument Manager.

2. The Contractor shall provide all necessary software support for ensuring successful interfacing with the middleware, remote connections and LIS system has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself.

2. The contractor provided hardware and software solution shall meet all VA Information Security, Hardware, Software and Network requirements in accordance with (IAW) VA Directive 6500. Any wireless equipment must be FIPS 140-2 compliant as well, and contractor must provide the FIPS 140-2 certification for any wireless equipment upon request.

2. All technology Contractor provides shall interface to VA licensed Data Innovations Instrument Manager sending all appropriate information to complete auto verification rules processing within the VA licensed Instrument Manager.

3. Connectivity and Conformance

3. Contractor must have a Memorandum of Understanding/Information Security Agreement (MOU/ISA) with the VA in sufficient time to meet the installation timeframes in section 4.

0. https://vaww.portal2.va.gov/sites/infosecurity/FY15CRISPAudit/CRISPRemediationContract/WorkSite/SitePages/MOU-ISA_Version2.aspx

3. Contractor shall meet VA OI&T information security requirements IAW VA Directive 6500.

3. Contractor shall provide remote monitoring and support of the hematology system while the manufacturer’s warranty is active. Contractor shall use remote monitoring to prevent instrument or testing issues, when possible, in addition to troubleshooting and support. The Contractor shall provide all hardware and software to implement the remote support system.

3. The hematology system’s operating software version must be approved for use on the VA network (Windows 10 and Server 2012/2016).

3. The hematology system must be capable of connecting to an HL7 interface and must comply with the VHA Lab HL7 Interface Specifications Document.

4. https://www.va.gov/vdl/application.asp?appid=71

4. https://www.va.gov/vdl/application.asp?appid=75

3. Any software and hardware solutions supplied and installed on VA workstations by the contractor must appear as an approved technology on the most current VA Technical Reference Model (TRM) or must appear on a TRM that is within 2 lifecycles of the most recent TRM approved version. For software or hardware solutions that do not meet these requirements at the time of contract award, Contractor shall obtain the required TRM approval without impacting installation timeframes.

5. https://www.oit.va.gov/Services/TRM/TRMHomePage.aspx.

0. Support Features

4. Training

0. The contractor shall provide an instrument training program for instruments installed at each facility that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services. Training shall be provided on the operation of the system, data manipulation, and basic trouble shooting and repair. The contractor shall reimburse the Government for the cost of airfare, room, and per diem for each Government participant who travels to the off-site training if the contractor elects to meet this requirement with a training program that involves off-site travel.

0. The contractor shall provide operator training on-site for all operators on all shifts.

0. Additional onsite training shall be provided 60-90 days after instrumentation’s go live date.

0. Contractor shall provide example policies and procedures such as standard operating procedure templates.

4. Waste

1. The Contractor shall provide documentation demonstrating that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges Contractor provides 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 decide if the waste is a hazardous waste or otherwise regulated. The determination and description shall address the following:

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

0. Waste ignitability (Reference 40 CFR §261.21)

0. Waste corrosivity (Reference 40 CFR §261.22)

0. Waste reactivity (Reference 40 CFR §261.23)

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

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

0. Solid Waste (Reference 40 CFR §261.2)

0. Exclusions (Reference 40 CFR §261.4)

1. 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. Contractor shall provide a description of all wastes the equipment or process 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.

1. The documentation the contractor provides will be used to work with the medical center, CBOCs, and the public 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.

1. Ability to separate alcohol waste from other waste for appropriate environmental disposal.

1. PACKAGING & MARKING

1. Packaging

0. All equipment shall be adequately packaged to prevent damage during shipping, handling, and storage. Bags or packages shall be whole, intact, and not otherwise torn or damaged. Upon delivery, the Government shall examine all packages. The Contractor shall be required to replace unacceptable or damaged products at the Contractor’s expense.

1. Marking

1. All items shall be marked clearly with the Contract Number, Obligation number, and delivery location within the facility, i.e., Pathology & Laboratory Services.

1. INSPECTION AND ACCEPTANCE / DELIVERIES & PERFORMANCE

2. Installation/Implementation

0. Implementation/transition timeframe: All sites shall have complete installation and go live of their system within one year of award of this contract.

0. Contractor shall execute an implementation plan which includes:

1. Installation - Contractor shall make every effort to conduct a concurrent implementation at all sites with weekly collaborative meeting. Contractor shall provide a dedicated project manager throughout the entire implementation. Installation shall also include conversion of all current data minimally including operator profiles.

1. Testing- Shall include at minimum a test of all analytes in addition through all testing phases (pre- analytical, analytical, and post-analytical). In addition, training must be provided to all sites.

1. Acceptance must meet the approval requirements of accrediting agencies and VA Pathology & Laboratory Medicine Services (P&LMS) approval at each facility to meet accreditation standards.

1. Go-Live- Dedicated project management and technical support shall be available the day of go-live at each site for 3 days.

1. Post Go-Live follow-up thirty day after go-live date.

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

1. Onsite Go live Instrument and Automation Support Requirements shall consist of 48 hours of continuous support. Daily onsite support for a total of five business days for each phase of implementation.

1. Must support successful implementation and a non-manual method of uploading historical data, i.e. operators and meters/analyzers in the transition from different system.

0. Post Implementation

2. Contractor shall assist customer with optimizing operation and utilization of the data management system to fully integrate desired testing instrumentation enhancing productivity and management of workflow. This shall include sending Contractor personnel to the site to optimize the analyzer, automation and data management work flows six months and twelve months after the system has gone live.

2. Optimization must include supplier to provide minimum staffing levels for pre-analytical, analytical, and post-analytical test performance.

0. Method Performance / Validation

3. Carryover for studies will meet CAP and CLSI guidelines.

3. 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, College of American Pathologists (CAP) standards and Federal regulations.

3. Limit of Blank (LoB, background) shall be performed on proposed instruments for WBC, Hb and PLT assays to enable differentiation of true cellular constituents of blood from sample-related constituents that originate from blood-free reagents, debris or electronic “noise”.

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 minimum 5-point linearity analysis that adheres to the Beer-Lambert Law and spans the entire range shall be performed as a minimum. This linearity analysis shall be performed for each measured test parameter provided.

3. Mixing study done onsite with 20 samples. Compare manual mixing with the equipment auto-mixing.

3. 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.

3. Sensitivity. Sensitivity may be validated concurrently with the linearity verifications.

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

3. Correlation studies for each analyte. A minimum of 40 samples, spanning the reportable range, shall be run by the present and the proposed method. Contractor shall analyze results and provide statistical data to support acceptance of the new method. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, ROC analysis, and meet current standards defined by CLSI.

3. 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.

3. 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 with medical director approval. 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.

3. 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.

3. 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.

2. Delivery: The Contractor shall deliver all hematology analyzers to participating VA medical facilities and CBOCs.

1. The delivery location is subject to change as required by the designated authority or authorized personnel at the receiving facility. The Contracting Officer Representative (COR) will notify the Contractor when delivery locations have been changed.

1. All deliveries shall be made from 8:00 a.m. to 4:00 p.m., Monday through Friday, and a copy of the packing list/slip shall be provided at time of delivery. The packages packing list/slip shall contain the complete contract number, purchase order number, shipping address, delivery location, items/quantity ordered, and items/quantity shipped. Standard orders shall be delivered no more than 30 working days after receipt or placement of order.

1. CONTRACT ADMINISTRATION DATA

3. Contractor Program Manager

0. The Contractor shall provide a program manager who shall be responsible for the installation and go live of the work under the contract. In addition, the program manager shall act as the main focal point of communication between the Contracting Officer and the Contractor. The name of this person shall be designated in writing to the Contracting Officer. The program manager shall have full authority to act on behalf of the Contractor on all contract matters relating under the contract.

Company Name:

Address:

Phone No:

Fax No:

Contact Name:

Email:

3. Hours of work

1. Contractor shall provide on-site repair services for all Contractor-provided equipment while the equipment is under standard manufacturer’s warranty. Contractor shall also provide technical support via phone seven (7) days a week, twenty-four (24) hours a day. Contractor shall provide these services at no additional charge to the Government as they are included with standard manufacturer’s warranty.

1. Holidays: Only emergency service shall be provided on National Holidays and only if authorized by the COR in advance.

1. When a National Holiday falls on a Sunday, the following Monday shall be observed as a National Holiday. When a National Holiday falls on a Saturday, the proceeding Friday is observed as a National Holiday by U.S. Government agencies. Also included in the definition of “Holidays” would be any other day, specifically declared by the President of the United States of America to be a National Holiday.

1. SPECIAL REQUIREMENTS

4. Physical Security and Facility Considerations

0. Identification, Parking, Smoking and VA Regulations (For any onsite services):

0. The Contractor employees and/or Subcontractors (collectively “Contractor personnel”) shall always wear visible identification while on the premises of the facilities within the VISN. Identification shall include a company identification card, which shall include the company name, employee name, title, and a photograph of the employee. Contractor personnel shall maintain a professional appearance commensurate to their industry.

0. Contractor personnel shall park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. The VA is not liable for parking violations of Contractor personnel under any conditions.

0. Any interior or exterior doors that are unlocked to gain access shall be kept locked during the performance of work unless it results in the creation of a safety hazard. In those instances, the Contractor is responsible to take necessary actions to maintain the same level of security prior to gaining access/performing work. Should any other devices need to be unlocked like an entry gate, those devices shall be locked immediately upon entry or exit. At no time shall the Contractor allow any person into a locked area or loan keys/access cards to another person. Contractor may be held in default for failure to comply with this requirement and subject the Contractor and its personnel to contractual and other legal remedies.

0. Contractor personnel are required to check into the facility Police & Security office at each visit to pick up a “contractor” badge prior to contacting the COR. The Contractor personnel shall also sign in and out each day at a designated location determined by the COR.

0. The Contractor agrees that none of its officers or employees shall use or reveal any research, statistical, medical, or security information which may be obtained during the performance of the work or as a result their presence on Government premises without the written consent of the Government

0. Smoking is prohibited inside any buildings at facilities within VISN 22.

0. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court.

0. The Contractor shall not allow its personnel to open desk drawers, cabinets, or to use office equipment, including the use of non-pay telephones for any purpose other than a local emergency call. The Contractor shall be responsible to provide all necessary equipment, tools, parts, and materials to perform the work. The Government shall not be obligated to provide any equipment, tools, parts, and materials to assist the Contractor in performing the work.

0. Background Checks:

1. Should the contract require Contractor’s personnel to maintain U.S. citizenship, the Contractor shall be responsible for compliance. Regardless of U.S. citizenship requirements, Contractor’s personnel are required to read, write, speak, and understand the English language, unless otherwise specified in this contract or agreed to by the Government.

1. The cost for such investigations shall be borne by the Contractor, either in advance or as reimbursement to the Government. The level of sensitivity shall be determined by the Government based on the type of access required. The level of sensitivity will determine the depth of the investigation and the cost thereof. At this time, the current estimated costs for such investigations are as follows:

LEVEL OF

SENSITIVITY

BACKGROUND

INVESTIGATION LEVEL

APPROXIMATE COST

1. The Contractor shall be required to furnish all applicable employee information required to conduct the investigation, such as, but not limited to, the name, address, and social security number of the Contractor’s personnel. The VA will provide all the necessary instructions and guidance for submission of the documents required to conduct the background investigation. Background investigations shall not be required for contract personnel assigned to Low Risk/Non-sensitive positions for 180 days or less under a single contract or series of contracts. However, a Security Access Clearance (SAC) background screening will be required for appropriate preliminary checks IAW VA Directive 0710.

4. Information Technology Security Considerations

1. Contractor shall not destroy information received from VA, or gathered/created by the Contractor in the course of performing this Contract without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor or its subcontractors 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, all of which are incorporated herein by reference. 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 completion or termination of the Contract.

1. System management middleware that is intuitive, provides direct operations control (e.g. over reflex testing), allows for a real test count, and allows for auto verification at the system level as required by the facility or LIS capability.

1. 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, which is incorporated by reference herein, upon: (i) completion or termination of the Contract 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 Contractor that contain VA information must be returned to the VA for sanitization or destruction or the Contractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of completion or termination of the Contract.

1. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for Contractor to remove and the VA to retain the electronic storage, then;

1. The equipment contractor must have an existing BAA if the device being traded in has sensitive information stored on it and electronic storage media from the system are being returned physically intact; and

1. Any fixed electronic storage media 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 required using VA approved and validated overwriting technologies/methods/tools.

1. Contractor shall comply with all terms and conditions of VA Handbook 6500.6 Section C and VA Directive 6550.

4. Insurance Requirements for work performed on Facility Grounds

2. The Contractor agrees to procure and maintain, while the Contract is in effect, Workers Compensation and Employee’s Public Liability Insurance in accordance with Federal and applicable State law.

2. The Contractor shall be responsible for all damage to property, which may be done by Contractor personnel engaged in the performance of this Contract.

2. Before commencing work under this Contract, Contractor shall furnish certification from his/her insurance company to the Contracting Officer indicating that the coverage specified by FAR 52.228-5 has been obtained and that it may not be changed or canceled without guaranteed thirty (30) day notice to the Contracting Officer.

2. Contractor shall provide copies of proof of Workers Compensation and Employee Public Liability Insurance within fifteen (15) calendar days after notification of Contract award.