Automated Blood Culture Analyzer System
Contracting Office Address
Department of Veterans Affairs;Network Contracting Office 6;100 Emancipation Drive;Hampton VA 23667
STATEMENT OF WORK Clinical Laboratory Microbiological Blood Culture System REVISED: 18 November 2013 Page 1 of 11 BACKGROUND: Bacteremia is a serious medical infection causing sepsis, septic shock, and possibly death. Rapid diagnosis is necessary to improve patient outcomes. A fully automated blood culture detection system is needed to detect the presence of bacteria in the bloodstream and aid laboratorians in providing fast and accurate results to physicians. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK 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 be able to simultaneously perform the complete profile, as described below, to 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). Equipment must maintain, or preferably reduce the number of work stations or overall labor required to accomplish the required testing by each laboratory. Vendor shall define measures to streamline testing to promote efficiency. If a Contractor offers a family of analyzers, VISN 6 technical evaluation panel will determine if the instrumentation(s) proposed meets needs of using facility. Equipment shall be acquired for each of the clinical laboratories located at the VISN 6 facilities listed in Attachment A. Only FDA approved equipment shall be acquired for each of the clinical laboratories located at the VISN 6 facilities listed in Attachment A. Remanufactured or used models will not be accepted. 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 within 14 days. 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. DEFINITIONS: Cost per Test (CPT)- as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (a) 5 year equipment use, (b) 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, (c) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (d) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge. TEST MENU: Refer to Attachment A for desired test menu and estimated annual volumes. GENERAL REQUIREMENTS: Primary analyzer(s)- Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all of the technical specifications of this solicitation. Operational Features- The instrumentation offered shall have the following: The system shall provide self-contained, continuous, computerized, automated monitoring of blood culture bottles with immediate, active (e.g. audible alarm) notification of microorganism growth based upon preprogrammed criteria and notification of termination of maximum programmed incubation period when no microorganism growth is detected. Blood culture bottles (both aerobic and anerobic) must be compatible with analyzer and include collection device adaptors if applicable. The system shall provide software, advanced reporting middleware and/or supporting instrumentation required to maintain, or improve levels of data retrieval, which may be used for epidemiology, or cost-savings measures. The vendor shall provide access to all certificates of analysis for the documentation of media as required by CLSI and College of American Pathologists (CAP) regulations either by hard copy or electronically. The vendor shall provide initial media inventory based on previous use, then establish a standing weekly/montly/quarterly shipment, if requested by the individual facilities, based on current use with the capability to fill emergency requests on- demand. Instrument/ bottles shall comply with Occupational Safety and Health Administration (OSHA) Bloodbourne Pathogens standard 1910.1030.The contractor shall provide shatter-proof bottles. The system shall be able to recognize expired bottles, over-filled and under-filled bottles with real-time notification alarms. The system shall allow for operator extension of programmed incubation times, while testing is in progress, without interruption of automatic continuous monitoring. The system shall accept manual entry of organism identification and other additional microbiological information (i.e. gram stain and organism identification). A varied selection of blood culture bottle configurations (low volume samples; antimicrobial agent removal resins) and formulations capable of maximizing growth potential of various microorganisms (e.g. aerobic and anaerobic bacteria, fungi, and mycobacteria) shall be available. Sufficient capacity and throughput to meet the volume, blood culture bottle variety, and service demands as defined in Attachment A. Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling. The system shall provide a data management system with motion-activated loading to provide rapid entry of bottles and a fully automated unloading system with visual and audible alerts. The system shall have the capability to flag/alert positive cultures by visual alert, sound alert, and remote alert systems. System should also detect and document time to positivity. A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be VA Technical Reference Manual (TRM) 19.5 approved and immediately available for implementation to the VA computerized hospital information system. The accuracy of the barcode reading must have less than a 1% failure rate. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. Equipment must accept, at a minimum, 10 characters in specimen identifier that is alphanumeric An operational system that is automated and provides continuous unattended testing throughout the day for a minimum of five days. The system will be capable of processing inoculated bottles that have been incubated off -line for up to 12 hours. Minimal daily and periodic maintenance. The Contractor will define tasks that are user performed and those that a Field Service Specialist must perform and include time requirements for each task. The reading chambers must be modular in nature allowing for the isolation of a given problem without having to shut the entire system down Technical Features- The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following: Bar-Code System: The system shall support bar-code recognition of inoculated bottles for tracking of bottles at entry into the system and throughout incubation until such time as the incubation has finalized as positive or negative for growth. Data Management System: The capability to record, store and print the following information: blood culture bottle location; length of incubation; time to detection; growth curve analysis of positive vials; required quality control and instrument maintenance information; patient demographic information and specimen results; the fill volume of the blood culture bottle; detailed epidemiology reports; and detailed reports of contamination rates by ward,collector, date and time. Shall be capable of maintaining all data and if interfaced, retransmit data for up to 24 hours in the event of normal electrical power interruptions via battery backup. Shall have a built-in quality control program to regularly monitor performance of vital components. Shall possess capability to backup all data to a secondary external storage format (e.g. compact disk). Shall have sufficient memory to store patient information and test results for a minimum of 1000 patients with downloading capability to an external medium for long term storage of patient records and other information. Blood Culture Bottles: Shall be easily distinguished (e.g. color coded) for utility or intended purpose. Shall be approved for culture of normally sterile body fluids other than blood. Shall be bar-coded with unique identifiers for loading and system monitoring. Shall be formulated as not to require venting prior to incubation of aerobic bottles. Shall have expiration date clearly marked. The minimum acceptable expiration date will be no less than 12 months. Hardware Features- The instrumentation shall have the following: A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. The Contractor shall supply equipment that performs satisfactorily in the laboratory at a relative humidity between 15-85% and a temperature between 50-90 °F (Fahrenheit) or 10-30 °C (Celsius). An touch screen on-board monitor/screen that is easily readable and at least 10 in. x 10 in. 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). The Contractor shall state their policy/conditions for obtaining a replacement printer. An uninterruptible power supply with line conditioner for each instrument provided. The Contractor shall be responsible for battery replacement and /or replacing/repairing the Universal Power Supply (UPS) should it become dysfunctional. 1.4.5 Interface Requirements The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system (See Attachment A). The Contractor shall provide any and all necessary software support for insuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of interfacing equipment is supplied in Attachment A. If a site already has a universal interface box, the Contractor is responsible for everything leading up to the box including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system. If a site does not have a universal interface and one is needed to optimally interface the instrument, then the Contractor is responsible for the acquisition of the universal interface box and everything else needed to connect with VA computerized hospital information system. If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system. 1.4.6 Method Validation Requirements- The Contractor shall assist each site in the performance all comparison and validation studies to include any materials and reagents needed for such correlation at no cost to the Government. The Contractor shall perform all statistical analysis, as applicable, and report data in an organized, clearly comprehensible format. This process shall be consistent with current CLSI Standards and related documents, CAP standards, and Federal Regulations. 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 FSS awarded contract) shall not be accepted. The Contractor shall supply accurate data for annual contract renewal by the required time frames, ensure timeliness of billing reconciliations, and have the ability to use the appropriate billing method required by the VA [i.e. Invoice Payment Processing System (IPPS)]. 126.96.36.199 The Contractor agrees that billing for new equipment shall not start until the live date which indicates all CAP studies for implementation have been completed, reviewed, and approved by the Laboratory Director. Support Features- Commercial marketing. The equipment models being offered shall be in current production as of the date an offer is submitted. For purposes of this solicitation, current production shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item included on the list of supplies defined in the Federal Supply Schedule contract and required to establish instruments for operation for performance of acceptance testing. The Contractor shall assist the Government with validation and method comparison studies. All materials and reagents needed for such correlation at no cost to the Government. The Contractor shall perform all of 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. The Contractor shall pay all shipping costs for the analyzer(s), any crossover supplies needed at installation and during training of staff. The Contractor shall pay all routine shipping fees for supplies, consumables and equipment parts required to perform patient testing. The Contractor shall perform, to the satisfaction of the Government, all verification studies including method comparisons with current analyzer, at the cost of the contractor. All verifications shall be approved by the by the department supervisor and the Chief Pathologist, to confirm that the analyzer has been placed in use and is ready for patient testing. 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 one operator per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, and room and board for each participant IAW rates set forth by the GSA. The contractor shall provide phlebotomy training to all staff (phlebotomists, Medical Technologists (MT), and Registered Nurses (RN) collecting blood cultures if necessary. The Contractor shall provide on-site refresher instrument training, wet workshops,advanced troubleshooting or any appropriate training in renewal years of the contract if so exercised at no cost to the facility. 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. A technical assistance/support center shall be available by telephone 24 hours/day,7 days/week with a maximum call back response timeof 1 hour at no charge. 188.8.131.52.1 The Technical support Center shall place a service call for repairs if the technologist is unable to repair the analyzer within one hour of trouble shooting with the hotline or on weekends/holidays/irregular hours when the facility s staffing will not allow for working with the hotline. 184.108.40.206.2 Equipment repair service shall be provided during core business hours (Monday through Friday 8:00am to 4:30pm). The Contractor may list their service option available. 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. 220.127.116.11.3 Equipment repair response time shall be no more than 24 hours. 18.104.22.168.4 The Contractor shall provide a preventative maintenance schedule to include a minimum of 2 scheduled preventative visits per year or as frequently as published in manufacturer s operator s manual and within 2 weeks of the scheduled due date. 22.214.171.124.5 Service shall include, at no charge, all labor, travel, and all replacement parts necessary to make repairs. The Contractor shall provide all replacement parts at no charge and any components necessary for the operation of the equipment to produce patient results. The Contractor shall replace any consumable/part (i.e. supplies currently on hand at the facility) used by the Field Service Representative (FSR) at no cost. 126.96.36.199.6 The support service shall follow-up all downtime calls within 1 hour. The FSR shall keep the facility informed of the time line for when repairs are to be completed. All repairs on instrument shall be complete (at no cost to the facility) within 24 hours from the time the FSR arrives. 188.8.131.52.7 The FSR shall, upon completion of each repair call or prior to departure, provide the visited site with a written or electronic documentation of the services performed. The report shall include, as a minimum, the following: date and time notified, date and time of arrival, serial number, type and model number of equipment, time spent for repair, and proof of instrument repair. 184.108.40.206.8 Each notification for an emergency repair service call shall be treated as a separate and new service call. 220.127.116.11.9 The Contractor s FSR must comply with each facility s requirements for onsite Contractor representatives. This may require a low risk background investigation by federal authorities paid by the Contractor and/or privacy training. Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system 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. Ancillary support equipment - The Contractor shall provide, install and maintain any and 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. Commercial offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g. Computer disc containing their procedure manual in CLSI format or an on-line procedure manual in the instrument software. Characterization of waste The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 Protection of the Environment Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated. The determination and description shall address the following: Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24) Waste ignitability (Reference 40 CFR §261.21) Waste corrosivity (Reference 40 CFR §261.22) Waste reactivity (Reference 40 CFR §261.23) Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31) Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33) Solid Waste (Reference 40 CFR §261.2) Exclusions (Reference 40 CFR §261.4) The Contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the Contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices. Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerosol and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with vendor response: Barium (Total) Cadmium (Total) Chromium (Total) Copper (Total) Cyanide (Total) Lead (Total) Mercury (Total) Nickel (Total) Silver (Total) Zinc (Total) Arsenic (Total) Selenium (Total) Tin (Total) pH Flash point (to higher than 200 F) BOD; biochemical oxygen demand The documentation the contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after the award of the BPA. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 90 day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government. Upon award of a BPA, the transition period for the awarded BPA 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. 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 BPA 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 BPA for cause under the Termination for Cause clause of the BPA. At the end of 90 days from award of the BPA, the awarded Contractor shall have full and sole responsibility for services under the awarded BPA. Standard and Quality of Performance- This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order [or BPA] is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor s technical specification or as quoted in any BPA at an effectiveness level of 90% or more. In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled Termination for cause. (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.) Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours. The Government will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes. During the term of the BPA, 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 themalfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment. Government s Responsibility- The user will perform routine maintenance and cleaning as required in the manufacturer s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph. Ownership of Equipment- Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer. The Contractor will identify if removable media is required to perform their duties. The Clinical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility. Prior to termination or completion of this BPA, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this BPA without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination or completion of the BPA. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the BPA or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the Contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination or completion of the BPA or disposal or return of the IT equipment, whichever is earlier Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the Contractor at the end of lease, for trade-in, or other purposes. The options are: Contractor must accept the system without the drive; VA s initial medical device procurement includes a spare drive which must be installed in place of the original drive at time of turn-in; or VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then; The equipment Contractor must have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or BPA. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The Information Security Officer (ISO) needs to maintain the documentation. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (20-JUN-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or firstname.lastname@example.org REGARDING THIS ISSUE.
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