SOW_Hematology_12072021.docx

Statement of Work (SOW) September 23, 2021

1. INTRODUCTION

VISN 21 – VA Sierra Pacific Network has a requirement for a Cost Per Reportable Results (CPRR) Indefinite Delivery, Indefinite Quantity (IDIQ) contract to maintain current immunochemistry patient testing. The contractor agrees to provide a price schedule that shall encompass Cost Per Reportable Results (CPRR) Pricing structures only, in accordance with the terms and conditions of the SOW to the Veterans Integrated Service Network 21 (VISN 21), identified as the Government herein. The services and prices are specified in the sections entitled Schedule of Supplies/Services of this contract.

Period of Performance: five (5) years

Place of Performance: The scope of this contract covers the entire area of responsibility (AOR) of VISN 21, including any clinic. The Government will be free to add onto this IDIQ for any Community-Based Outpatient Clinic (CBOCs), clinics, etc. The addresses and locations may change, but the requirement applies to VISN 21.

VISN 21 Locations:

· VA San Francisco Healthcare System, 4150 Clement Street, San Francisco, CA 94121

· VA Palo Alto Healthcare System, 3801 Miranda Avenue, Palo Alto, CA 94304

· VA Northern California Healthcare System, 10535 Hospital Way, Mather, CA. 95655

· VA Central California Healthcare System, 2615 E. Clinton Avenue, Fresno, CA 93703

· VA Pacific Islands Healthcare System, 459 Patterson Road, Honolulu, HI 96819

· VA Sierra Nevada Healthcare System, 975 Kirman Avenue, Reno, NV 89502

· VA Southern Nevada Healthcare System, 6900 North Pecos Road, North Las Vegas, NV 89086

2. SCHEDULE OF SERVICES

Cost Per Reportable Result

3. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

3.1. SCOPE OF PROCUREMENT:

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). The instrument must be FDA approved for all parameters as listed in this requirement.

3.1.1. Equipment must maintain, or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory from their current state.

3.1.2. If Contractor offers a family of analyzers, VISN 21 technical evaluation panel will determine if instrumentation proposed meets needs of using facility.

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

3.1.4. 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. Any consumable that is required to maintain operation that is not available should be communicated clearly before the award, and the technical panel may have a preference to avoid additional purchases outside of the CPRR contract. 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, standards, and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award.

3.1.5. 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, or supplies are used in troubleshooting the equipment, 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.

3.2. DEFINITIONS:

3.2.1. Cost per Patient Reportable Result (CPRR)- Cost-Per-Reportable-Result 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. This per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required producing 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.

3.2.2. Parameter definitions-

3.2.2.1. CBC- Complete Blood Count (6-part with Immature Granulocyte)

3.2.2.2. WBC- White Blood Cell Count

3.2.2.3. Diff- Automated Differential

3.2.2.4. RBC- Red Blood Cell Count

3.2.2.5. MCH- Mean Corpuscular Hemoglobin

3.2.2.6. MCV- Mean Corpuscular Volume

3.2.2.7. MCHC-Mean Corpuscular Hemoglobin Concentration

3.2.2.8. RDW- Red Cell Distribution Width

3.2.2.9. MPV-Mean Platelet Volume

3.2.2.10. Digital Cell Imaging Differential (scanned from slide made/stained by analyzer)

3.2.3. Complete Blood Count (CBC) and White Blood Cell (WBC) Automated Differential (DIFF), Reticulocyte and Body Fluid Cell Count-

3.2.3.1. CBC with six-part WBC Diff by Fluorescent Flow Cytometry is preferred and shall include the following parameters at a minimum: hemoglobin, hematocrit, WBC, RBC, platelet, MCH, MCV, MCHC, RDW, and MPV. Six-part WBC Diff shall include at a minimum: % neutrophils, % lymphocytes, % monocytes, % immature granulocytes, % eosinophils, and % basophils. Six-part differential should be reportable using absolute values.

3.2.3.2. Reticulocyte Count is required, performed by Fluorescent Flow Cytometry is preferred

3.2.3.3. Automated body fluid count should include the following parameters at a minimum RBS, WBCs, % mononuclear cells and % polymorphonuclear cells.

3.2.3.4. All available advanced parameters shall be communicated in the bid for the technical panel to review with the pathologists at each site. Preference will be given to parameters that the pathologists feel provide the most benefit to the patient populations.

3.3. TEST MENU: Refer to Attachment A for desired test menu, equipment needed, and estimated annual volumes.

3.4. GENERAL REQUIREMENTS:

3.4.1. Primary analyzer(s) – Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined in the attachments to the SOW. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all the technical specifications of this solicitation. Those additional analyzer(s) offered should be the same analyzer as the primary analyzer, acting as a backup. Refer to Attachment A for site that need two analyzers.

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

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

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

3.4.2.3. Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling.

3.4.2.4. A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system (which is currently interfaced via Data Innovations to VistA), and Cerner later (expected during the term of this contract). The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system. Sites with the need to transmit absolute differential values from the digital slide imaging instrumentation prefer to have a middleware capable of calculating and transmitting these values without manual entry. This need will be notated by the request of middleware on Attachment A.

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

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

3.4.2.4.3. Equipment must accept, at a minimum, 10 characters in specimen identifier that is all numeric.

3.4.2.5. Ability to prioritize STAT testing without compromising existing programmed testing.

3.4.2.6. Minimal daily, monthly, and periodic maintenance.

3.4.2.7. Ability to store and retransmit records (minimum of 24 hours of maximal instrument throughput) in case of interface outage.

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

3.4.2.9. No requirements for sample pre-treatment.

3.4.2.10. Capability to detect out of range quality control.

3.4.2.11. Ability to accept various types of sample containers.

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

3.4.3.1. On-board QC data management system with a minimum storage capacity of 12 QC files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data.

3.4.3.2. Ability to monitor instrument performance. Preference given to remote monitoring via IP address.

3.4.3.3. On board reagent inventory system, to include lot numbers, expiration dates, and reagent volumes.

3.4.3.4. Ability to calibrate in all sample modes.

3.4.3.5. Minimal carryover.

3.4.3.6. Long calibration stability.

3.4.3.7. Prefer high interference tolerance.

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

3.4.4.1. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. Review floor plans and space limitations per site Preference may be given by technical panel to smaller footprint.

3.4.4.2. An on-board monitor/screen that is easily readable.

3.4.4.3. A printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient’s name and accession or unique identifier number (UID). Backup printer or replacement printer should be on site or available within 2 days of printer failure.

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

3.4.4.5. An auto sampling system that includes cap piercing closed tube aspiration, auto-loader, and auto-mixing.

3.4.4.6. Primary tube sampling.

3.4.4.7. Clot detection.

3.4.4.8. Manual sampling mode that reads barcode label; ideally both closed and open manual sampling modes is desirable.

3.4.4.9. If multiple analyzers share a computer, a backup computer must be provided.

3.4.4.10. If multiple analyzers share a power source –a backup power source must be provided.

3.4.5. Specific Equipment Requirements

1) Ability to process rules for accepting or rejecting results.

2) Ability to process rules for repeat analysis

3) Ability to reflex samples to the slide maker stainer, on those sites with a connected system.

4) Analyzer can halt patient testing if QC fails (or suitable solution to be reviewed by technical panel).

2.4.5.2.6 Ability to connect to a total lab automation system preferred.

3.4.6. Method Performance/Validation Requirements

3.4.7. 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:

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

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

3.4.7.3. 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.

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

3.4.9. Support Features-

3.4.9.1. 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. The latest technology offered is required.

3.4.9.2. 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 IDIQ contract and required to establish instruments for operation for performance of acceptance testing. The Contractor shall perform, to the satisfaction of the Government, all validation studies including precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all the statistical analysis as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format.

3.4.9.3. Training. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services and minimally equivalent to the terms and conditions for training defined in the contract. The first year the contractor shall provide basic operator training to all system operators on the operation of the system, data manipulation, and basic trouble shooting and repair. Additionally, the Contractor shall provide “Train the Trainer” training for a minimum of 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. Off-site training preferred. A training program that involves off-site travel shall include the cost of airfare, room, and board for each participant. Each instrument should provide training to ensure outpatient clinics within the same health care system receive training.

3.4.9.4. Equipment Preventative Maintenance/Repair Service. The Contractor must 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:

3.4.9.5. 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 delivery order; however, it does refer to significant changes in the hardware operational capability.

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

3.4.9.7. Preferred to have large volume reagent in concentrated form that will connected to a water system. Saving storage room and tech time.

3.4.9.8. Interface Requirements

3.4.9.9. 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.

3.4.9.10. 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 decide if the waste is a hazardous waste or otherwise regulated.

3.4.9.10.1. The determination and description shall address the following:

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

3.4.9.10.1.2. Waste ignitability (Reference 40 CFR §261.21)

3.4.9.10.1.3. Waste corrosivity (Reference 40 CFR §261.22)

3.4.9.10.1.4. Waste reactivity (Reference 40 CFR §261.23)

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

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

3.4.9.10.1.7. Solid Waste (Reference 40 CFR §261.2)

3.4.9.10.1.8. Exclusions (Reference 40 CFR §261.4)

3.4.9.10.2. 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.

3.4.9.10.3. Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e., mercury, thimerosal, and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with vendor response:

3.4.9.10.3.14. pH

3.4.9.10.3.15. Flash point (to higher than 200F)

3.4.9.10.3.16. BOD; biochemical oxygen demand

3.4.9.10.4. 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 the waste from each device can legally be disposed of via the sewerage system

3.4.9.11. Implementation will be coordinated with the facility for each location that an analyzer will be installed. The timeline and software and hardware function needs to be coordinated and approved within each facility.

3.4.9.12. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than April 1, 2022. 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 a 90-day timeframe if the extension is through no fault of the Contractor and is a result of delays due to the Government.

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

3.4.9.12.2. 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 delivery order 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 delivery order for cause under the Termination for Cause clause of the delivery order.

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

3.4.9.12.4. The Mather laboratory will be under renovation during the timeframe of the contract and the contractor must be willing to install and validate in the current laboratory and in a temporary location and then move to a permanent location once the renovation is completed.

3.4.10. 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 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 delivery order at an effectiveness level of 90% or more.

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

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

3.4.10.3. Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period 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.

3.4.10.4. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when more than the minimum of 100 hours.

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

3.4.10.6. During the term of the delivery order, 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.

3.4.11. 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.

3.4.12. 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.

3.4.13. The Contractor will identify if removable media is required to perform their duties. The Clinical Engineering Department, Bio Medical Engineering, or OI&T 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.

3.4.14. Prior to termination or completion of this delivery order, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor while performing this delivery order 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 delivery order.

3.4.15. 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 delivery order 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 delivery order or disposal or return of the IT equipment, whichever is earlier

3.4.16. 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:

3.4.16.1. Contractor must accept the system without the drive.

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

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

3.4.17. 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.

3.4.17.1. 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

3.4.17.2. 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 delivery order.

3.4.17.3. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The Information Security Officer (ISO) needs to maintain the documentation.

(End of Statement of Work)