Cost-Per-Test Clinical Laboratory Analyzers Statement of Work.pdf

STATEMENT OF WORK – Blood Bank Automation

1. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

1.1. SCOPE OF PROCUREMENT:

1.1.1. 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), the Clinical and Laboratory Standards Institute (CLSI), FDA (Federal Drug Administration), and AABB (American Association of Blood Bank).

1.1.2. Equipment must maintain, or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory.

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

1.1.4. 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. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards, and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award.

1.1.5. 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, 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.

1.2. DEFINITIONS:

1.2.1. Cost per Test (CPT)- as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers – Contractors are required to provide a price for each test that can be performed on its equipment. The per test 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 and reporting of a test result, (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel. Contractors are required to provide delivery, installation, and removal of equipment at no additional charge.

1.2.2. Business Associate Agreement (BAA)- A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule.

1.3. TEST MENU/REAGENTS: Refer to Attachment A for desired test menu and estimated annual volumes.

1.3.1. CPT

ANTI-IGG C3D

ANTI-IGG

BUFFERED GEL

ANTI-MONOCLONAL

ANTI-B MONOCLONAL

ANTI-A,B MONOCLONAL

AB MONO GROUP

A/B/D MONO & REVERSE GROUPING

A/B/D/A/B/D MONOCLONAL GROUPING

ANTI-D MONOCLONAL

MONOCLONAL CONTROL

MONOCLONAL Rh Phenotype

MONOCLONAL ANTI-C

MONOCLONAL ANTI-c

MONOCLONAL ANTI-E

MONOCLONAL ANTI-e

1.4. GENERAL REQUIREMENTS:

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

1.4.1.1. Fully automated system with a high processing capacity for pre-transfusion compatibility tests.

1.4.1.2. The capability of performing analysis on 100% of the tests listed in section 2.4.2 Technical Features.

1.4.1.3. The system must use gel card agglutination technology to mirror current blood bank methodology at St. Louis, Columbia, and Kansas City Medical Centers.

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

1.4.1.5. 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.

1.4.1.6. Minimal daily, monthly, and periodic maintenance.

1.4.1.7. Testing system must have capability for a minimum of pre-diluted antibody identification panels FDA cleared for use in conjunction with the instrument.

1.4.1.8. The Instrument must have the capability of processing from the direct specimen tube.

1.4.1.9. Vendor must have a demonstrated ability to supply automated and non-automated reagents for Blood Bank testing under their own brand.

1.4.1.10. For those sites requesting back up analyzers, a workstation must be provided that mirrors the technology of the primary analyzer.

1.4.1.11. The backup analyzer/workstation must have the capability of using the same reagents as the primary analyzer.

1.4.1.12. The system must have bi-directional interface capability with VBECS through Data

Innovations. VBECS connection must fully be operational at another VA site. The vendor must be willing to take the steps necessary to meet the information security requirements of VISN 15 sites. If it is a Windows based system, it must be Windows 7 or newer.

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

1.4.2.1. ABO/RH Grouping (forward and reverse)

1.4.2.2. Antibody Screens using pooled cell, two-cell, three-cell reagents

1.4.2.3. Antibody Identification

1.4.2.4. Antigen typing: Anti- C, Anti- c, Anti- E, Anti- e, Anti- K

1.4.2.5. Direct Antiglobulin Test (DAT)

1.4.2.6. FDA approved for immediate spin and IgG crossmatch

1.4.2.7. RBC donor unit ABO/Rh retypes

1.4.2.8. QC testing

1.4.2.9. Phenotyping reagents (Attachment A)

Instrumentation shall have the following:

1.4.2.10. Walkaway testing capability.

1.4.2.11. Minimal reagent preparation.

1.4.2.12. The capability to use column agglutination technology (CAT).

1.4.2.13. The capability of using 100% of the cards (no wastage of cards).

1.4.2.14. The capability of incubation and centrifugation of gel cards.

1.4.2.15. The capability of processing multiple runs simultaneously (continuous access).

1.4.2.16. Capability to use interchangeable sample and reagent lineal racks.

1.4.2.17. Ability to accept several types of specimens: plasma, serum, or red cells.

1.4.2.18. The ability to random load samples, reagents, and gel cards on instrument.

1.4.2.19. Integrated quality control system.

1.4.2.20. Ability to perform testing in a single card that includes a control well.

1.4.2.21. The capability of dispensing samples and reagents with minimal carryover.

1.4.2.22. The capability of barcode read on reagents and samples.

1.4.2.23. Ability of reading and interpreting of results.

1.4.2.24. Ability to monitor instrument performance.

1.4.2.25. Ability to grade and interpret gel cards using a data image processing software.

1.4.2.26. Minimal waste (does not require drain in the floor).

1.4.2.27. Open system with the capability to use gel cards with various reagent manufacturers for

Red Blood Cells and universal liquid Antisera.

1.4.2.28. Ability to use with the system additives for enhancing antibody detection tests such as:

Enlisst-II, Bromelase 30, Specific Albumin 22%, Specific Albumin 30%, Immusol Compact, PEG.

1.4.2.29. Capability to store at least 1000 patient results in a database for immediate recall.

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

1.4.3.1.1. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory and should be capable of being placed on a bench top or standalone

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

1.4.3.1.3. An uninterruptible power supply for each instrument provided, as necessary, including replacement of batteries

1.4.3.1.4. A printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient’s name and accession or unique identifier number (UID)

1.4.3.1.5. Method performance/comparison: Shall be at the expense of the Contractor, shall include materials and reagents, and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP), The Joint Commission Standards and federal regulations and AABB (American Association of Blood Bank), for the following:

1.4.3.1.6. Implementation plan should include validation of software with correlation and precision studies, if needed. Studies shall be performed on the proposed instrument for each test

1.4.3.1.7. Correlation studies. This shall determine if samples with correct results are correlated to the reference (current) method. Contractor shall correlate current method and provide data to support acceptance of the new method.

1.4.3.1.8. Precision study. This shall determine if testing samples multiple times yields the same results for all events. The contractor shall run agreed upon number of samples for validation of precision antibody detection as determined by antibody sample availability.

Precision studies should be run over a period of 10 days. Variations should be kept at an absolute minimum.

1.4.3.1.9. Sensitivity. This shall determine if the samples that test positive when a condition tested exists. Sensitivity may be validated concurrently with the performance verifications.

1.4.3.1.10. Specificity Studies. This shall determine samples that test negative when the condition tested for is not present

1.4.3.1.11. 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 program(s) shall be provided to each laboratory at no charge

1.4.3.1.12. Vendor will assist the user in setting up and maintaining/trouble shooting user-defined assays

1.4.4. Support Features

1.4.4.1. 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.

1.4.4.2. 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 Federal Supply Schedule contract and required to establish instruments for operation for performance of acceptance testing. The Contractor shall assist the Government with all validation studies including precision, method comparison with current methodology, accuracy (recovery), carryover, determination of sensitivity and specificity. All materials and reagents needed for such correlation at no cost to the Government. The Contractor shall perform all the statistical analysis and report data in an organized, clearly comprehensible format. This process shall be completed within two weeks of installation of the analyzer at each site and shall be consistent with current CLSI and related documents, CAP Standards and Federal Regulations.

1.4.4.3. 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. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally two “key operators” at each facility and one training slot per year over the life of the agreement.

1.4.4.4. 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:

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

1.4.4.4.2. Equipment repair service shall be provided during core business hours, Monday through Friday, 8am to 5pm. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the contractor and VA laboratory personnel.

1.4.4.4.3. Equipment response time shall be no more than 24 hours.

1.4.4.4.4. A minimum of 1 scheduled preventative maintenance calls per year.

1.4.4.4.5. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following:

1.4.4.4.5.1. Date and time notified

1.4.4.4.5.2. Date and time of arrival

1.4.4.4.5.3. Serial number, type, and model number of equipment

1.4.4.4.5.4. Time spent for repair, and

1.4.4.4.5.5. Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance

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

1.4.4.5. 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 contract; however, it does refer to significant changes in the hardware operational capability.

1.4.4.6. Ancillary support equipment - The Contractor shall provide, install, and maintain through the life of the contract, 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.

1.4.4.7. 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 requirements below).

1.4.4.8. The contractor shall provide all necessary software support for ensuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of interfacing equipment is supplied in the chart below.

1.4.4.9. If any of the VISN facilities already have 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.

1.4.5. Commercial offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g., Computer disc containing their procedure manual in CLSI format or an on-line procedure manual in the instrument software.

1.4.6. 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.

1.4.6.1.1. The determination and description shall address the following:

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

1.4.6.1.1.2. Waste ignitability (Reference 40 CFR §261.21)

1.4.6.1.1.3. Waste corrosivity (Reference 40 CFR §261.22)

1.4.6.1.1.4. Waste reactivity (Reference 40 CFR §261.23)

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

1.4.6.1.1.6. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed)

(Reference 40 CFR §261.33)

1.4.6.1.1.7. Solid Waste (Reference 40 CFR §261.2)

1.4.6.1.1.8. Exclusions (Reference 40 CFR §261.4)

1.4.6.1.2. 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.

1.4.6.1.3. 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, 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:

1.4.6.1.3.1. Barium (Total)

1.4.6.1.3.2. Cadmium (Total)

1.4.6.1.3.3. Chromium (Total)

1.4.6.1.3.4. Copper (Total)

1.4.6.1.3.5. Cyanide (Total)

1.4.6.1.3.6. Lead (Total)

1.4.6.1.3.7. Mercury (Total)

1.4.6.1.3.8. Nickel (Total)

1.4.6.1.3.9. Silver (Total)

1.4.6.1.3.10. Zinc (Total)

1.4.6.1.3.11. Arsenic (Total)

1.4.6.1.3.12. Selenium (Total)

1.4.6.1.3.13. Tin (Total)

1.4.6.1.3.14. pH

1.4.6.1.3.15. Flash point (to higher than 200F)

1.4.6.1.3.16. BOD; biochemical oxygen demand

1.4.6.1.4. 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.

1.4.6.2. Implementation/transition timeframe - Vendor must deliver instruments prior to 30 days of completion of previous contract. The implementation of the services/requirements described in this solicitation shall be completed no later than 60 days after the award of the contract. This timeline is based on a reasonable attempt of the Contractor to complete all the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 60-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

1.4.6.2.1. Upon award of a contract, the transition period for the awarded contract to have all equipment and peripherals installed and operational shall be from date of award through 60 days. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

1.4.6.2.2. Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 60 days for the transition of all services under the awarded contract 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 contract for cause under the Termination for Cause clause of the contract.

1.4.6.2.3. At the end of 60 days from award of the contract, the awarded Contractor shall have full and sole responsibility for services under the awarded contract.

1.4.7. 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 contract] 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 contract at an effectiveness level of 90% or more.

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

1.4.7.2. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled “Termination for cause.”

(The Contractor shall receive revenue for tests reported during the 90-day acceptance period.)

1.4.7.3. 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.

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

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

1.4.7.6. During the term of the contract, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment.

1.4.8. Government’s Responsibility- The user will perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph.

1.4.9. Ownership of Equipment- Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer.

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

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

1.4.12. 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 contract 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 contract or disposal or return of the IT equipment, whichever is earlier

1.4.13. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the Contractor at the end of lease, for trade-in, or other purposes. The options are:

1.4.13.1. Contractor must accept the system without the drive;

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

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

1.4.14. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

1.4.14.1. 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

1.4.14.2. 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 contract.

1.4.14.3. 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.