SOW Microbiology Rapid PCR Singleplex.docx

STATEMENT OF WORK – Clinical Laboratory Microbiology Instrumentation: Rapid PCR Singleplex

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 be able to simultaneously perform the testing as described below and 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).

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

1.1.3. If Vendor offers a family of analyzers, VAPA technical evaluation panel will determine if instrumentation proposed meets needs of using facility.

1.1.4. Equipment shall be acquired for the clinical laboratories located at the VISN facility listed in Attachment A.

1.1.5. The Vendor is required to make available a continuous supply 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 Vendor. 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 award.

1.1.6. Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the equipment, or the vendor has failed to comply with the requirements for routine supply delivery, the vendor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the vendor 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 vendor’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 vendor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

1.2. DEFINITIONS:

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

1.2.2. Parameter Definition(s) - This section intentionally left blank.

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

1.4. GENERAL REQUIREMENTS:

1.4.1. 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 herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all of the technical specifications of this solicitation. Those additional analyzer(s) offered meeting the definition of a primary analyzer shall be equivalent to a back-up analyzer (see definition below) and shall replace the requirement for offering that category of equipment.

1.4.2. (Applies only if selected) Back-up Analyzer- Equipment required in support of operations for the VA laboratories in the event the primary analyzer(s) becomes non-operational/non-functional. This category of equipment shall only be operated during periods of time when the primary instrumentation is not available for use. As such, the requirements for consumable supplies, i.e. reagents, quality control material, calibrators, etc., shall be minimal and corollary to the successful operation of the primary instrumentation. Specific tests that require back-up performance are listed in Attachment A.

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

1.4.3.1. System will be a non-waived RT-PCR test analyzer that determines infectious disease states. RT-PCR analyzer detects the presence or absence of a target nucleic acid. The tests will assist practitioners in diagnosing infectious disease states on in real time.

1.4.3.2. The capability of performing analysis on 100% of the tests listed in Attachment A. The offeror’s menu will be FDA-approved and include bacterial organisms, viral, mycobacterium to limit the amount of work needed on self-validtion/verification studies.

1.4.3.3. Sufficient capacity and throughput to meet the volume and service demands as defined in Attachment A. The instrument shall have capabilities of identifying organisms directly from different specimens like blood, sputum, stool, wound, nasal/nasopharyngeal swabs, and cultures as well.

1.4.3.4. The instrument shall have bench side accessibility.

1.4.3.5. The instrument allows for random access (can put multiple tests on, while analyzer is running other tests).

1.4.3.6. The instrument shall be FDA 21 CFR Part 11 compliant.

1.4.3.7. A preparatory apparatus and equipment shall be provided for specimen preparation, and there shall be an easy method for securely linking specimen information to each cartridge

1.4.3.8. The system shall provide self-contained, automated identification to the species level. The test component should be single-use, and automate the process of sample extraction, amplification and detection. The system should allow for single assay (not multiplex) testing.

1.4.3.9. 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.

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

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

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

1.4.3.11. Equipment must accept, at a minimum, BCBC characters in specimen identifier that is alpha and/or numeric.

1.4.3.12. Minimal daily, monthly, and periodic maintenance.

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

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

1.4.4.1. Singleplex and Multiplex PCR test that integrates sample preparation, amplification, detection and analysis all into one system.

1.4.4.2. The system should allow for single assay (not multiplex) testing per specimen.

1.4.4.3. Should require minimum hands-on-time; and, a turnaround time of approximately one hour.

1.4.4.4. Window-based instrument control and data analysis software.

1.4.4.5. Barcode reader for data input

1.4.4.6. Automated qualitative analysis and reporting

1.4.4.7. Separate advanced analysis and reporting

1.4.4.8. The capability of accurately and reliably identifying organisms directly from specimens including nasal/nasopharyngeal swabs, respiratory, stool and cultures.

1.4.4.9. Respiratory specimen target organisms should include:

1.4.4.9.1. SARS CoV2 (COVID 19)

1.4.4.9.2. RSV

1.4.4.9.3. Influenza A and B

1.4.4.9.4. Mycobacterium tuberculosis

1.4.4.10. Stool specimen target organisms should include:

1.4.4.10.1. Clostridium difficile (Tox B)

1.4.4.11. Nasal Swab

1.4.4.11.1. MRSA (Methicillin Resistance Staphylococcus Aureus)

1.4.4.12. Software or equipment modifications as needed and, when commercially available, to comply with changes in standards of testing established by CLSI, Center for Disease Control (CDC) and other governing or authoritative bodies

1.4.4.13. Built-in quality control program to regularly monitor system performance.

1.4.4.14. Included middleware shall include, as a standard, the ability for continuous remote notification of critical events, and delayed processing steps.

1.4.5. Data Management- The System shall have the following;

1.4.5.1. Capability to provide varied options for analysis and reporting/review of cumulative patient data on organisms isolated and antimicrobial profiles.

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

1.4.5.2.1. Required quality control and instrument maintenance information

1.4.5.2.2. Patient demographic information and specimen results

1.4.5.2.3. Capability of manipulating/sorting the patient demographic information and patient microbiology test results to generate epidemiological reports, i.e. antibiograms, etc.

1.4.5.2.4. Sufficient memory to store patient information and test results for two years with downloading capability to an external medium for long term storage of patient records and other information.

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

1.4.6.1. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory.

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

1.4.6.3. 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).

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

1.4.7. The Vendor shall assist the Government with validation and method comparison studies. All materials and reagents needed for such correlation shall be provided at no cost to the Government. The Vendor 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.

1.4.8. Reports- The vendor 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 the facility, reporting the savings realized and shall be shared with the 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. There will be no additional charges for any reports required as part of the agreement.

1.4.9. Support Features-

1.4.9.1. 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.

1.4.9.2. Start-Up Reagents. The Vendor 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.

1.4.9.3. Training. The Vendor 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 vendor’s agreement. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair.

1.4.9.4. Equipment Preventative Maintenance/Repair Service. The vendor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support equipment, e.g. water system, offered according to the following terms:

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

Equipment repair service shall be provided during core business hours. See Attachment A defining core business hours of each facility included in this solicitation. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the vendor and VA laboratory personnel.

Equipment repair response time shall be no more than hours.

Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.

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

date and time notified date and time of arrival serial number, type and model number of equipment time spent for repair signature of facility representative (technician/technologist) who was briefed at the close of work for the incident/repair/service proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

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

1.4.9.5. Upgrades - The vendor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of –the art technology, at no additional charge to the Government. 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 Vendor supported, etc. This does not refer to replacing the original piece of equipment provided under the BPA; however, it does refer to significant changes in the hardware operational capability.

1.4.9.6. Ancillary support equipment - The vendor shall provide, install and maintain through the life of the instrument, as indicated, 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 vendor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc.

Interface Requirements The vendor 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 vendor 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 vendor 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 vendor 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 vendor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system.

1.4.9.7. Commercial offerings - The vendor 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 CSLI format or an on-line procedure manual in the instrument software.

1.4.9.8. Characterization of waste – The vendor 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.

1.4.9.8.1. The determination and description shall address the following:

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

1.4.9.8.1.2. Waste ignitability (Reference 40 CFR §261.21)

1.4.9.8.1.3. Waste corrosivity (Reference 40 CFR §261.22)

1.4.9.8.1.4. Waste reactivity (Reference 40 CFR §261.23)

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

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

1.4.9.8.1.7. Solid Waste (Reference 40 CFR §261.2)

1.4.9.8.1.8. Exclusions (Reference 40 CFR §261.4)

1.4.9.8.2. The vendor 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 vendor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

1.4.9.8.3. The vendor 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:

1.4.9.8.3.14. pH

1.4.9.8.3.15. Flash point (to higher than 200F)

1.4.9.8.3.16. BOD; biochemical oxygen demand

1.4.9.8.4. The documentation the vendor 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.

1.4.9.9. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after the award. This timeline is based on a reasonable attempt of the Vendor to complete all of the necessary implementation requirements within the stated timeframe. Vendor shall not be penalized for implementation timelines that extend beyond the 90 day timeframe, if the extension is through no fault of the Vendor and is a result of delays due to the Government.

1.4.9.9.1. Upon award for purchase, the transition period for the award 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. Training at the facility on the use and care of the analyzer must occur by a vendor trained representative.

1.4.9.9.2. Vendor shall provide with its quotation an implementation plan for installation of new equipment. Vendor’s submitted plan shall not exceed 90 days for the transition of all services under the purchase award including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Delivery and set up of the analyzer will be performed by trained service representative(s). Failure of the Vendor to conform to the transition period shall be considered as sufficient cause to terminate agreement for cause.

1.4.9.9.3. At the end of 90 days from purchase award, the awarded Vendor shall have full and sole responsibility for services under the awarded agreement.

1.4.10. 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 Vendor’s technical specification or as quoted in any BPA at an effectiveness level of 90% or more.

1.4.10.1. 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.

1.4.10.2. 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 Vendor shall receive revenue for tests reported during the 90-day acceptance period.)

1.4.10.3. 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 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 Vendor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition.

1.4.10.4. 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 in excess of the minimum of 100 hours. [reference: Master FSS]

1.4.10.5. The Government will maintain daily records to satisfy the requirements of this paragraph and shall notify the Vendor 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.

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

1.4.11. 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.

1.4.12. Ownership of Equipment- Title to the equipment shall remain with the Government. All ancillary equipment or parts used as part of the system, including removeable media and the information stored, will also be owned by the Government.

1.5. INFORMATION SECURITY

1.6. 1. GENERAL

Vendors, vendor personnel, shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

1.7. 2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

1.8. a. A vendor/subcontrator shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

1.9. b. All vendors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for vendors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

1.10. c. Vendor personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

1.11. d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the vendor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

1.12. e. The vendor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the vendor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the vendor or subcontractor prior to an unfriendly termination.

1.13. 3. VA INFORMATION CUSTODIAL LANGUAGE

1.14. a. Information made available to the vendor or subcontractor by VA for the performance or administration of this agreement or information developed by the vendor/subcontractor in performance or administration of the agreement shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the vendor/subcontractor's rights to use data as described in Rights in Data- General, FAR 52.227-14(d) (1).

1.15. b. VA information should not be co-mingled, if possible, with any other data on the vendors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the vendor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on site inspections of vendor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

1.16. c. Prior to termination or completion of this agreement, vendor/subcontractor must not destroy information received from VA, or gathered/created by the vendor in the course of performing this agreement without prior written approval by the VA. Any data destruction done on behalf of VA by a vendor/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 vendor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of agreement.

1.17. d. The vendor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this agreement.

1.18. e. The vendor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on vendor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the vendor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

1.19. f. If VA determines that the vendor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the vendor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

1.20. g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

1.21. h. The vendor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

1.22. i. The vendor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

1.23. j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the vendor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The vendor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

1.24. k. Notwithstanding the provision above, the vendor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the vendor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that vendor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

1.25. l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the vendor/subcontractor must complete a Vendor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.

1.26. 4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT (if applicable)

1.27. a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

1.28. b. The vendor/subcontractor shall certify to the COTR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

1.29. c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default “program files” directory and silently install and uninstall.

1.30. d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

1.31. e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

1.32. f. The vendor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.

1.33. g. The vendor/subcontractor agrees to:

1.34. (1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

1.35. (a) The Systems of Records (SOR); and

1.36. (b) The design, development, or operation work that the vendor/subcontractor is to perform;

1.37. (2) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and

1.38. (3) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR.

1.39. h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the vendor/subcontractor is considered to be an employee of the agency.

1.40. (1) “Operation of a System of Records” means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

1.41. (2) “Record” means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person’s name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

1.42. (3) “System of Records” means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

1.43. i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as “Systems”), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

1.44. j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than ____ days.

1.45. k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within ____ days.

1.46. l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

1.47. 5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

1.48. a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, vendors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The vendor’s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COTR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA’s network

1.49. involving VA information must be reviewed and approved by VA prior to implementation.

1.50. b. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

1.51. c. Outsourcing (vendor facility, vendor equipment or vendor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the vendor’s systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government-owned (government facility or government equipment) vendor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

1.52. d. The vendor/subcontractor’s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA’s POA&M management process. The vendor/subcontractor must use VA’s POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Vendor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector

1.53. General. The physical security aspects associated with vendor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

1.54. e. The vendor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COTR. The government reserves the right to conduct such an assessment using government personnel or another vendor/subcontractor. The vendor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

1.55. f. VA prohibits the installation and use of personally-owned or vendor/subcontractor owned equipment or software on VA’s network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.

1.56. g. 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 vendor/subcontractor or any person acting on behalf of the vendor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the vendors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the vendor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

1.57. h. 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 vendor at the end of lease, for trade-in, or other purposes. The options are:

1.58. (1) Vendor must accept the system without the drive;

1.59. (2) VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

1.60. (3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

1.61. (4) 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;

1.62. (a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

1.63. (b) 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 preapproved and described in the purchase order or contract.

1.64. (c) A statement needs to be…