DRAFT_Statement of Work - Instruments.docx

STATEMENT OF WORK

DEPARTMENT OF VETERANS AFFAIRS MEDICAL CENTERS

VA Palo Alto Healthcare System (VAPAHCS)

CLINICAL LABORATORY MICROBIOLOGICAL SYSTEM

FOR IDENTIFICATION AND ANTIBIOTIC SUSCEPTIBILITY OF MICROORGANISMS

1. Scope:

The Contractor shall provide VAPHCS with standardized microbiological system for the identification (ID) and antimicrobial susceptibility testing (AST) of microorganisms which shall have the capability of performing or reporting the clinical parameters as defined for the VAPHCS facilities. The instruments shall be able to simultaneously perform the complete profile 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). The Contractor shall quote the suggested/recommended equipment VAPAHCS sites that meet the requirements of the facility.

Contractor shall provide all equipment, standards, controls, supplies, parts, accessories, Uninterruptible Power Supply UPS, printers, barcode and laser, and any other item required for the proper operation of contractor owned organism identification (ID) and antimicrobial susceptibility (AST) analyzer for microbiology and peripherals necessary for the generation of Microbiology Cost Per Reportable Result (CPRR) services for VAPHCS. The Contractor shall provide analyzers and supplies to facility in accordance with the estimate given.

Definitions:

Cost Per Reportable Result (CPRR): The per reportable result price shall include costs covering (a) equipment use, (b) all reagents, standards, controls, supplies, consumable/disposable items, parts, accessories, Uninterruptible Power Supply UPS, printers, barcode and laser and any other item required for the proper operation of the contractor’s equipment and necessary for the generation of a patient reportable result. This does not include those items approved for exclusion by the government such as printer paper, labels etc. This per patient reportable result price shall also encompass all costs associated with dilution, repeat and confirmatory testing required producing a single patient reportable result. It will also include the material to perform as well as all other costs associated with quality control, and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI) (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.

2. Pricing:

VAPHCS will provide the equipment requirements needed by the medical center. Pricing shall be based on fair market value.

Offerors shall provide pricing for all equipment, components, training, and service.

a. All necessary maintenance to keep equipment in manufacturer's operating conditions, both preventive maintenance, and emergency repairs.

b. Training for VAPAHCS personnel operating equipment.

c. Contractors are required to provide delivery, installation and removal of equipment at no additional charge.

3. Requirements:

a. Each model of clinical laboratory analyzer offered shall comply with all general requirements stated herein. Each Contractor shall submit as part of their offer, technical data or descriptive literature to ascertain that the equipment offered meets the requirement.

b. The Contractor shall provide FDA approved automated identification and antibiotic susceptibility systems/analyzers. Remanufactured or discontinued models are unacceptable.

c. The Contractor shall state the failure mean time (between failure and mean time to repair) for each piece of equipment offered. Emergency replacement of equipment shall be provided by the Contractor.

d. Offered testing equipment shall be new state-of-the-art equipment. Remanufactured and discontinued models will not be accepted

e. Utilities specification

4. Microbiologic System Specific Requirements:

The Contractor shall assess equipment, workflow, volumes and space to meet the individual VAPAHCS site’s requirements with minimum cost.

General Requirements:

a. The system shall provide self-contained, automated identification and antibiotic susceptibility testing system for aerobic, facultative, fastidious, and anaerobic microorganisms and yeasts.

b. The system shall have a data management system with varied options for analysis and reporting/review of cumulative patient data on organism’s isolated and antimicrobial profiles and allow for manual modification of susceptibility breakpoints to comply with new CLSI guidelines until the vendor applies necessary software updates.

c. Clinical laboratory assays currently performed at the VAPAHCS Pathology and Laboratory Medicine Services shall include, but may not be limited to the following assays:

d. Organism Identification

e. Antimicrobial Susceptibility, by truly measured MIC method

f. Detection of antibiotic resistance

g. Expert rule for Unusual ID & AST results

h. Software to prepare site specific reports

i. The system should have battery backup UPS capable of maintaining data for at least 24 hours in the event of a facility power failure. This will be maintained or replaced by the contractor.

j. The Contractor shall provide hardware/software upgrades necessary to maintaining the integrity of the system at no additional charge to the government. These must be provided as they become available and as they are being offered to commercial customers. Changes in CLSI guidelines shall be implemented into the software upgrades in a timely manner.

k. The Contractor shall provide to each facility a copy of operating procedures in Clinical and Laboratory Standards Institute (CLSI) digital format at time of installation using software compatible with VA (Microsoft Office WORD).

l. Offered models of organism identification and antimicrobial susceptibility analyzers for clinical microbiology laboratory shall be capable of producing accurate and reproducible assays on biological and other specimens by established in vitro diagnostic methods. Models provide accurate test assay results for sample specimens up to the manufacturer's defined maximum testing capabilities without excessive malfunctions, breakdowns, or service calls.

m. The Contractor shall provide hardware and operating system software upgrades necessary to maintaining the integrity of the system at no additional charge to the Government during the lifetime of the instrument. These enhancements shall be delivered and installed at each participating VAPAHCS medical facility within 60 days of issuance to the commercial market. Changes in CLSI guidelines shall be implemented into the software upgrades in a timely manner.

n. A printer for each analyzer shall be provided by the contractor. This will be maintained or replaced by the contractor.

o. The system should also offer independent, manual processing and printing of a chartable result in the event of LIS downtime.

p. Contractor offered equipment shall perform satisfactorily at any laboratory temperature between 10 and 32⁰C and relative humidity between 15 and 85 percent.

q. Contractors offered ID/AST microbiology analyzers shall conform to VAPAHCS existing laboratory space.

5. Interfacing:

The instrument proposed shall be capable of bi-directional, bar-coded, and uploading to the host computer). All contractor computer systems need to have Windows 10 or higher to be compatible with VA security requirements.

Provide a bi-directional interface for Data Innovations using VISTA. The contractor shall provide all Data Innovations and cables, and all necessary software and licensing required for Dawning operations/interfacing with the contractor’s equipment.

The fully operational interface (both hardware and software) should be immediately available for implementation to the VA VISTA hospital information system at the time of the award. The Contractor shall provide all necessary software support for ensuring that successful interfacing has been established with these systems. Specific requirements for the communication of data streams shall be unique to the instrument system involved and dictated by the manufacturer itself. The Computer must interface with VISTA (at a minimum it should be capable of downloading patient demographics from host computer, integrating this information with test results and could recall and re-transmit test results to host computer.

6. Ancillary Equipment and Supplies:

The Contractor shall provide, install and maintain, as indicated, any and all ancillary support equipment, consumables/supplies, parts and accessories necessary to fully operate the ID &AST analyzer(s) as defined in these specifications, e.g., McFarland standards, cabinetry to support/house the analyzer (if necessary) and universal interface equipment, Uninterruptible Power Supply (UPS) capable of supporting the full scope of equipment operation with a built-in line conditioner, for each proposed analyzer. 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. the Contractor shall provide a report printer and replace such if needed.

7. Maintenance and Repair:

The Contractor shall be able to provide emergency equipment repair and preventative maintenance and any incremental support equipment, e.g. water system, offered according to the following terms:

a. Apart from the specific maintenance and repair requirements stated herein, which shall have precedence, preventive maintenance, emergency repair, maintenance credit for equipment malfunction, and replacement laboratory equipment.

b. A technical assistance or support center shall be available by telephone hotline 24/7 days/week with a maximum callback response time of 1 hour with on-site service provided, not to exceed 24 hours following determination that site service is required. The technical assistance center shall be staffed with personnel who are fluent in English without the use of an interpreter.

c. Emergency repairs shall be performed after initial telephone notification that the equipment is inoperative. The contractor should provide the Government with a designated point of contact and telephone number and shall plan to enable his maintenance representative to receive such notification.

d. Ability to provide equipment service on a 24-hour/day 7 day/week basis for hospital-based systems.

e. Scheduled preventative maintenance calls shall occur at a frequency to meet the minimum manufacturer’s requirements to keep the equipment in optimal operating condition.

f. Every notification for a repair service call shall be treated as a separate and new service call.

g. The Contractor shall be on-site at the affected VA facility to perform emergency repair service to testing and ancillary instruments within twenty-four (24) hours after receipt of initial telephone notification of a malfunction. The Contractor shall provide medical center maintenance coverage 24 hours per day, seven days per week including all Federal holidays. The Contractor shall be required to provide maintenance Monday through Friday from 8:00 a.m. until 5:00 p.m., including Federal holidays. The contractor shall provide technical support service to assist in troubleshooting 24 hours per day, seven days per week including Federal holidays.

h. The following facilities require extended hours (on-site 7 days per week, including contractor’s holidays; at least 8:00 am – 5:00 pm, local Pacific Time) service in accordance with the contractor’s FSS contract.

i. In addition to the above, the contractor shall furnish a malfunction incident report to the installation upon completion of each repair call. The report should include, as a minimum, the following:

· date and time notified.

· date and time of arrival.

· serial number, type and model number(s) of equipment.

· time spent on repair.

· description of malfunction and repair; and

· proof of repair that includes documentation of a sample run of quality control verifying acceptable performance

j. The Contractor shall not leave a service call open pending verification that repairs completed by the contractor’s maintenance personnel. For each instrument provided the contractor shall treat each notification for an emergency/repair service call from the Government as a separate and new service call.

k. Should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of normal working days in one calendar month, a determination will be made by the designated representative of the Government to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with the manufacturer’s instructions, shall be solely that of the contractor. The Government agrees to maintain the equipment according to manufacturer’s specifications. Each instrument provided by the contractor shall maintain an uptime of 90% in each month of the term of the agreement.

8. Invoicing:

It is understood that it may not be possible to meet all VA specific requirements utilizing a single instrument. As such, Contractors shall be required to submit pricing in different formats. Contractors shall provide an all-inclusive cost to perform all tests and requirements as outlined herein, as applicable and offers shall provide a price based on each individual color code as provide in the price schedule.

9. Training:

The Contractor shall provide training on the operation of the system, data manipulation, preventative maintenance and basic trouble shooting and repair for key operators (see site specific training requirement). Any training program that involves off-site travel shall include the cost of airfare, room and board for each participant. A training or competency checklist shall be provided by the Contractor.

Provide on-site vendor operator training for all personnel who will run instruments with training provided for all applicable staff.

10. Site preparation:

Specifications shall be furnished in writing by the Contractor as a part of the equipment quote. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to the manufacturer’s claimed specifications.

The Contractor shall be responsible for assessing the space available in each facility to ensure the right size equipment is provided; thereby not creating a safety hazard. The equipment offered shall fit the existing space with no alterations or requirements for site prep work.

11. Implementation and Transition:

The Contractor shall provide with its quotation a transitioning plan for the complete transition including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all comparisons and validations. This transition shall be completed no later than 60 days after the award. This timeline is based on a reasonable attempt of the Contractor to complete all the necessary implementation requirements within the stated timeframe.

12. Comparison and Validation of Analyzer:

The Contractor shall perform at each site, to the satisfaction of the Government, at no cost to the Government all comparison and validation/verification studies to include any material and reagents needed for such correlation. The Contractor shall perform all the statistical analysis and report data in an organized, clearly comprehensible format. The Contractor shall accommodate clinical preferences and requests by the laboratory. 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, TJC standards and Federal Regulations.

13. Site-Specific Requirements:

Equipment must meet the volume and turnaround time requirements, if specified, of the facilities used. See the Facilities’ Specific Requirements and Proposed Equipment below.

a. VA Palo Alto Healthcare System, 3801 Miranda Ave., Palo Alto, CA 94304

· Walk-away capability required

· 2 key operators to all-expense paid off site training.

· Provide in-house training for other technologists.

· Repair or replacement of printers, UPS, and any other equipment required is at the expense of the contractor.

· Conventional and rapid ID panels.

· The vendor shall supply all interface software support, and cables needed for bidirectional interface. These cables will be sufficient in length to reach from the analyzer to the DI server.

· The contractor shall be on site at the affected VA facility to perform emergency repair within 24 hours after receipt of initial telephone notification of a malfunction.

14. Technical Requirements:

In addition to the general requirements for the Microbiology Cost-Per-Reportable Result (CPRR) stated above, the Contractor shall make every attempt to provide equipment, peripherals and supplies meeting the following requirements, characteristics and capabilities:

Characteristics:

a. The system should have a comprehensive and extensive database of bacteria and yeast species that is consistent with CLSI guidelines. Vendor should provide software upgrades at no charge to the government when CLSI guidelines change or are updated, or changes in bacterial nomenclature.

b. Provides a broad test menu available with reliable methodologies and has capability to expand menu options for ID & AST for gram-positive, gram-negative organism and yeast organism, Identification of anaerobes, fastidious, and yeast organisms.

c. The range of FDA approved ID panels for the accurate detection of gram-positive, gram-negative, anaerobes, Haemophilus, Neisseria, fastidious, HACEK, and yeast organisms, such as conventional, rapid, combo, and synergy panels.

d. The system should offer a comprehensive array of bacterial antimicrobial susceptibility panels to meet facility needs. The contractor shall supply a list of available susceptibility panels as well as a list of antibiotic exceptions for their methodology at time of quote.

e. Strep microbroth dilution MIC panel with laked Horse blood broth

f. Rapid anaerobic, and yeast ID panel.

g. Identification of organisms in the method of Mass Spectrometry Time of Flight (MALDI-TOF).

h. Broad range of FDA approved AST panels with lower concentration of current antibiotics for the detection of resistance patterns which includes D-test, cefoxitin screen, ESBL, KPC, NDM-1, metallo, etc.

i. Resistance detection and confirmation mechanism for the following but not limited to ESBL confirmation, carbapenemase resistance enterobactericeae and/or Acinetobacter (CRE/CRAB), NDM-1, AmpC, Vancomycin resistance Enterococci (VRE), Methicillin resistance S. aureus (MRSA), Vancomycin intermediate resistant S. aureus (VISA/VRSA), etc. with microbroth dilution MIC, panels.

j. AST results by direct measure rather than calculated MICs.

k. Panels should not require a great deal or comprehensive or extra testing menu to achieve an accurate ID/AST result.

l. Provides and performs bar-code operations for specimens, panels, and controls.

m. System shall be an open system which can accommodate user-defined methods such as, entering susceptibility for drugs, selection of organisms, etc.

n. Contractors may provide variants of instruments accommodating various workload requirements and backup needs. Geographical location of like instruments is sufficient to assist in reagent/supply crisis situations.

o. Additionally, Contractor shall provide details of the location of maintenance personnel in relation to VAPAHCS, and the amount of territory covered by that personnel and experience of maintenance personnel servicing VAPAHCS.

p. Contractor shall supply all interface cables needed for bidirectional operation. These cables will be sufficient in length to reach from the analyzer to the DI server.

q. Organism identification and sensitivity panels can be used on all the automated, semi-automated and manual systems in the manufacturer’s line of instruments.

r. Organism identification and sensitivity panels can be read manually if automated or semi-automated analyzer is non-functional or to confirm interpretations from automated or semi-automated analyzers.

s. If manual reading and interpretation of identification and sensitivity panels are not available, vendor must supply a back-up instrument with similar/same capabilities as primary instrument.

t. The QC material shall be included in the contract for all tests in use.

u. Operation and maintenance procedures shall be provided on electronic media, instrument or website. The contractor shall state which medium the procedures are provided.

15. Software:

Instrument software should be versatile and easy to use with the following capabilities:

a. Cost of auto-verification programming and validation covered in contract should the VA software change allow for this option during the duration of this contract.

b. Contractor shall provide, as part of its offer, a list of VA sites currently using interfaces for the instrument offered.

c. As part of your offer provide the number of instruments operating in the United States and provide information on said equipment, to include record of hardware and software reliability, reagent recall history in past two years, percentage of downtime and average number of service calls per month for each piece of equipment/systems offered.

d. Look up capabilities for results on samples being processed.

e. Ability to store Quality control of reagents/panels.

f. Ability to alarm/flag repeat testing of unusual isolates, susceptibilities, and drug-bug combination.

g. Contributes to enhanced workflow efficiency and improved patient outcomes

h. Ability to detect and alert/flag operator of instrument problems.

i. Ability to detect and alert/flag operator of empty reagent containers/vials

j. Ability to alarm/flag reflex testing to confirm unusual results per CLSI & FDA guidelines.

k. On-board sample inventory

l. Software allows review of QC and patient results to help in troubleshooting.

m. Software is upgradable (provide list of versions).

n. Desirable features of software include programmable rules for reporting, auto-verification, and reflex testing.

o. Recognizes isolates that are declared public health risks and isolates that should be reported to the public health department.

p. Above software features can be accomplished by instrument software or middleware. If middleware is needed, include necessary hardware and software in contract and CPRR calculation.

q. The system should also offer independent, manual processing and printing of a chartable result in the event of LIS downtime.

r. Software allows user defined configurations such as suppressions of antibiotic results, antibiotic reporting order, interpretation and warning flags, etc.

s.

Equipment should be versatile and provide efficient hardware capabilities.

a. Uninterruptible power supply (surge protection + battery backup) provided and serviced by vendors for sites requiring such.

b. Hardware upgrades are available as needed and include any necessary training.

c. The laboratory has space for instruments and peripherals. Vendor will supply plans for placement of new analyzer(s) prior to initial method validation and after transitioning to new instruments. Plans must be site-specific and accurately reflect the available space at each site.

Equipment and software shall at a minimum provide operator-friendly maintenance requirements.

a. Routine maintenance takes minimal tech time.

b. Routine maintenance and function checks cause little or no delay to testing.

c. Reliable technology used for detection of drug resistance.

d. Instrument troubleshooting is easy and straightforward

e. Instruments are connected via modem to hotlines that can view instrument status and remotely control troubleshooting process. Contractor has a high percentage of technical services calls answered directly by technician (no message left for call-back).

16. Reagent and Standards:

a. Convenient Reagent look-up and Standard Use of instrument

b. Extended reagent shelf life.

c. Reagent storage room temperature vs. refrigerated

d. Reagents have prolonged shelf life and stability once opened/on-board.

e. Various reagent sizes for large/small volume facilities

f. On-board reagent inventory.

g. Instrument alerts operators to reagents/consumables needed to complete testing.

h. As new methods are released for instruments, the updates are automatically enabled promptly and at no cost to user.

18. VA Information and Information System Security and Privacy 18.1 GENERAL. This entire section applies to all acquisitions requiring any Information Security and Privacy language. Contractors, contractor personnel, subcontractors and subcontractor personnel will be subject to the same federal laws, regulations, standards, VA directives and handbooks, as VA personnel regarding information and information system security and privacy.

18.2.

VA INFORMATION CUSTODIAL LANGUAGE. This entire section applies to all acquisitions requiring any Information Security and Privacy language.

a. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter “contract”) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is FAR 52.227-19, Commercial Computer Software License.

b. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General.

c. VA information will not be co-mingled with any other data on the contractor’s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization.

d. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with Federal and VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector General (OIG), and/or Government Accountability Office (GAO) staff during periodic control assessments, audits, or investigations.

e. The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies.

f. The contractor shall not make copies of VA information except as specifically authorized and necessary to perform the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed in accordance with VA Directive 6500, VA Cybersecurity Program and VA Information Security Knowledge Service.

g. If a Veterans Health Administration (VHA) contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken in accordance with VHA Directive 1605.05, Business Associate Agreements. If there is an executed national BAA associated with the contract, VA will determine what actions are appropriate and notify the contactor.

h. The contractor shall store and transmit VA sensitive information in an encrypted form, using VA-approved encryption tools which are, at a minimum, Federal Information Processing Standards (FIPS) 140-2, Security Requirements for Cryptographic Modules (or its successor) validated and in conformance with VA Information Security Knowledge Service requirements. The contractor shall transmit VA sensitive information using VA approved Transport Layer Security (TLS) configured with FIPS based cipher suites in conformance with National Institute of Standards and Technology (NIST) 800-52, Guidelines for the Selection, Configuration and Use of Transport Layer Security (TLS) Implementations.

i. The contractor’s firewall and web services security controls, as applicable, shall meet or exceed VA’s minimum requirements.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two situations: (i) in response to a qualifying order of a court of competent jurisdiction after notification to VA CO (ii) with written approval from the VA CO. The contractor shall refer all requests for, demands for production of or inquiries about, VA information and information systems to the VA CO for response.

k. Notwithstanding the provision above, the contractor 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 medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection with Human Immunodeficiency Virus (HIV). If the contractor is in receipt of a court order or other requests for the above-mentioned information, the contractor shall immediately refer such court order or other requests to the VA CO for response.

l. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract will be protected and secured in accordance with VA Directive 6500 and Identity and Access Management (IAM) Security processes specified in the VA Information Security Knowledge Service.

m. Any data destruction done on behalf of VA by a contractor shall be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management, VA Handbook 6300.1, Records Management Procedures, and applicable VA Records Control Schedules.

n. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Directive 6500 and NIST 800-88, Guidelines for Media Sanitization prior to termination or completion of this contract. If directed by the COR/CO, the contractor shall return all Federal Records to VA for disposition.

o. Any media, such as paper, magnetic tape, magnetic disks, solid state devices or optical discs that is used to store, process, or access VA information that cannot be destroyed shall be returned to VA.The contractor shall hold the appropriate material until otherwise directed by the Contracting Officer’s Representative (COR) or CO. Items shall be returned securely via VA-approved methods. VA sensitive information must be transmitted utilizing VA-approved encryption tools which are validated under FIPS 140-2 (or its successor) and NIST 800-52. If mailed, the contractor shall send via a trackable method (USPS, UPS, FedEx, etc.) and immediately provide the COR/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the COR/CO within 30 business days of termination of the contract.

p. All electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) used to store, process or access VA information will not be returned to the contractor at the end of lease, loan, or trade-in. Exceptions to this paragraph will only be granted with the written approval of the VA CO.

18.3.

ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS. This section applies when any person requires access to information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract.

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees and subcontractors only to the extent necessary to perform the services specified in the solicitation or contract. This includes indirect entities, both affiliate of contractor/subcontractor and agent of contractor/subcontractor.

b. Contractors and subcontractors shall sign the VA Information Security Rule of Behavior (ROB) before access is provided to VA information and information systems (see Section 4, Training, below). The ROB contains the minimum user compliance requirements and does not supersede any policies of VA facilities or other agency components which provide higher levels of protection to VA’s information or information systems. Users who require privileged access shall complete the VA elevated privilege access request processes before privileged access is granted.

c. All contractors and subcontractors working with VA information are subject to the same security investigative and clearance 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 contractors shall be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office of Human Resources and Administration/Operations, Security and Preparedness (HRA/OSP) is responsible for these policies and procedures. Contract personnel who require access to classified information or information systems shall have an appropriate security clearance. Verification of a Security Clearance shall be processed through the Special Security Officer located in HRA/OSP. Contractors shall conform to all requirements stated in the National Industrial Security Program Operating Manual (NISPOM).

d. All contractors and subcontractors shall comply with conditions specified in VAAR 852.204-71(d); Contractor operations required to be in United States. All contractors and subcontractors working with VA information must be permanently located within a jurisdiction subject to the law of the United States or its Territories to the maximum extent feasible. If services are proposed to be performed abroad the contractor must state where all non-U.S. services are provided. The contractor shall deliver to VA a detailed plan specifically addressing communications, personnel control, data protection and potential legal issues. The plan shallbe approved by the COR/CO in writing prior to access being granted.

e. The contractor shall notify the COR/CO in writing immediately (no later than 24 hours) after personnel separation or occurrence of other causes. Causes may include the following:

(1) Contractor/subcontractor personnel no longer has a need for access to VA information or VA information systems.

(2) Contractor/subcontractor personnel are terminated, suspended, or otherwise has their work on a VA project discontinued for any reason.

(3) Contractor believes their own personnel or subcontractor personnel may pose a threat to their company’s working environment or to any company-owned property. This includes contractor-owned assets, buildings, confidential data, customers, employees, networks, systems, trade secrets and/or VA data.

(4) Any previously undisclosed changes to contractor/subcontractor background history are brought to light, including but not limited to changes to background investigation or employee record.

(5) Contractor/subcontractor personnel have their authorization to work in the United States revoked.

(6) Agreement by which contractor provides products and services to VA has either been fulfilled or terminated, such that VA can cut off electronic and/or physical access for contractor personnel.

f. In such cases of contract fulfillment, termination, or other causes; the contractor shall take the necessary measures to immediately revoke access to VA network, property, information, and information systems (logical and physical) by contractor/subcontractor personnel. These measures include (but are not limited to): removing and then securing Personal Identity Verification (PIV) badges and PIV – Interoperable (PIV-I) access badges, VA-issued photo badges, credentials for VA facilities and devices, VA-issued laptops, and authentication tokens. Contractors shall notify the appropriate VA COR/CO immediately to initiate access removal.

g. Contractors/subcontractors who no longer require VA accesses will return VA-issued property to VA. This property includes (but is not limited to): documents, electronic equipment, keys, and parking passes. PIV and PIV-I access badges shall be returned to the nearest VA PIV Badge Issuance Office. Once they have had access to VA information, information systems, networks and VA property in their possessions removed, contractors shall notify the appropriate VA COR/CO.

18.4.

TRAINING. This entire section applies to all acquisitions which include section 3. a. All contractors and subcontractors requiring access to VA information and VA information systems shall successfully complete the following before being granted access to VA information and its systems:

(1) VA Privacy and Information Security Awareness and Rules of Behavior course (Talent Management System (TMS) #10176) initially and annually thereafter.

(2) Sign and acknowledge (electronically through TMS #10176) understanding of and responsibilities for compliance with the Organizational Rules of Behavior, relating to access to VA information and information systems initially and annually thereafter; and

(3) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system or information access [to be defined by the VA program official and provided to the VA CO for inclusion in the solicitation document – i.e., any role-based information security training]. b. The contractor shall provide to the COR/CO a copy of the training certificates and certification of signing the Organizational Rules of Behavior for each applicable employee within five days of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the required training is complete.

18.5.

SECURITY INCIDENT INVESTIGATION. This entire section applies to all acquisitions requiring any Information Security and Privacy language.

a. The contractor, subcontractor, their employees, or business associates shall immediately (within one hour) report suspected security / privacy incidents to the VA OIT’s Enterprise Service Desk (ESD) by calling (855) 673-4357 (TTY: 711). The ESD is OIT’s 24/7/365 single point of contact for IT-related issues. After reporting to the ESD, the contractor, subcontractor, their employees, or business associates shall, within one hour, provide the COR/CO the incident number received from the ESD.

b. To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved and the circumstances surrounding the incident, including the following: (1) The date and time (or approximation of) the Security Incident occurred.

(2) The names of individuals involved (when applicable).

(3) The physical and logical (if applicable) location of the incident.

(4) Why the Security Incident took place (i.e., catalyst for the failure).

(5) The amount of data belonging to VA believed to have been compromised.

(6) The remediation measures the contractor is taking to ensure no future incidents of a similar nature.

c. After the contractor has provided the initial detailed incident summary to VA, they will continue to provide written updates on any new and relevant circumstances or facts they discover. The contractor, subcontractor, and their employes shall fully cooperate with VA or third-party entity performing an independent risk analysis on behalf of VA. Failure to cooperate may be deemed a material breach and grounds for contract termination.

d. VA IT contractors shall follow VA Handbook 6500, Risk Management Framework for VA Information Systems VA Information Security Program, and VA Information Security Knowledge Service guidance for implementing an Incident Response Plan or integrating with an existing VA implementation.

e. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG, and the VA Office of Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

f. The contractor shall comply with VA Handbook 6500.2, Management of Breaches Involving Sensitive Personal Information, which establishes the breach management policies and assigns responsibilities for the oversight, management and reporting procedures associated with managing of breaches.

g. With respect to unsecured Protected Health Information (PHI), the contractor is deemed to have discovered a data breach when the contractor knew or should have known of breach of such information. When a business associate is part of VHA contract, notification to the covered entity (VHA) shall be made in accordance with the executed BAA.

h. If the contractor or any of its agents fails to protect VA sensitive personal information or otherwise engages in conduct which results in a data breach involving any VA sensitive personal information the contractor/subcontractor processes or maintains under the contract; the contractor shall pay liquidated damages to the VA as set forth in clause 852.211-76, Liquidated Damages—Reimbursement for Data Breach Costs.

18.6 INFORMATION SYSTEM DESIGN AND DEVELOPMENT. This entire section applies to information systems, systems, major applications, minor applications, enclaves, and platform information technologies (to include the subcomponents of each) designed or developed for or on behalf of VA by any non-VA entity.

a. Information systems designed or developed on behalf of VA at non-VA facilities shall comply with all applicable Federal law, regulations, and VA policies. This includes standards for the protection of electronic Protected Health Information (PHI), outlined in 45 C.F.R. Part 164, Subpart C and information and system security categorization level designations in accordance with FIPS 199, Standards for Security Categorization of Federal Information and Information Systems and FIPS 200, Minimum Security Requirements for Federal Information Systems. Baseline security controls shall be implemented commensurate with the FIPS 199 system security categorization (reference VA Handbook 6500 and VA Trusted Internet Connections (TIC) Architecture).

b. Contracted new developments require creation, testing, evaluation, and authorization in compliance with VA Assessment and Authorization (A&A) processes in VA Handbook 6500 and VA Information Security Knowledge Service to obtain an Authority to Operate (ATO). VA Directive 6517, Risk Management Framework for Cloud Computing Services, provides the security and privacy requirements for cloud environments.

c. VA IT contractors, subcontractors and third-party service providers shall address and/or integrate applicable VA Handbook 6500, VA Handbook 6517, Risk Management Framework for Cloud Computing Services and Information Security Knowledge Service specifications in delivered IT systems/solutions, products and/or services. If systems/solutions, products and/or services do not directly match VA security requirements, the contractor shall work though the COR/CO to identify the VA organization responsible for governance or resolution. Contractors shall comply with FAR 39.1, specifically the prohibitions referenced.

d. The contractor (including producers and resellers) shall comply with Office of Management and Budget (OMB) M-22-18 and M-23-16 when using third-party software on VA information systems or otherwise affecting the VA information. This includes new software purchases and software renewals for software developed or modified by major version change after the issuance date of M-22-18 (September 14, 2022). The term “software” includes firmware, operating systems, applications and application services (e.g., cloud-based software), as well as products containing software. The contractor shall provide a self-attestation that secure software development practices are utilized as outlined by Executive Order (EO)14028 and NIST Guidance. A third-party assessment provided by either a certified Federal Risk and Authorization Management Program (FedRAMP) Third Party Assessor Organization (3PAO) or one approved by the agency will be acceptable in lieu of a software producer's self-attestation.

e. The contractor shall ensure all delivered applications, systems and information systems are compliant with Homeland Security Presidential Directive (HSPD) 12 and VA Identity and Access management (IAM) enterprise identity management requirements as set forth in OMB M-19-17, M-05-24, FIPS 201-3, Personal Identity Verification (PIV) of Federal Employees and Contractors (or its successor), M-21-31 and supporting NIST guidance. This applies to Commercial Off-The-Shelf (COTS) product(s) that the contractor did not develop, all software configurations and all customizations. f. The contractor shall ensure all contractor delivered applications and systems provide user authentication services compliant with VA Handbook 6500, VA Information Security Knowledge Service, IAM enterprise requirements and NIST 800-63, Digital Identity Guidelines, for direct, assertion-based authentication and/or trust-based authentication, as determined by the design and integration patterns. Direct authentication at a minimum must include Public Key Infrastructure (PKI) based authentication supportive of PIV and/or Common Access Card (CAC), as determined by the business need and compliance with VA Information Security Knowledge Service specifications.

g. The contractor shall use VA authorized technical security baseline configurations and certify to the COR that applications are fully functional and operate correctly as intended on systems in compliance with VA baselines prior to acceptance or connection into an authorized VA computing environment. If the Defense Information Systems Agency (DISA) has created a Security Technical Implementation Guide (STIG) for the technology, the contractor may configure to comply with that STIG. If VA determines a new or updated VA configuration baseline needs to be created, the contractor shall provide required technical support to develop the configuration settings. FAR 39.1 requires the population of operating systems and applications includes all listed on the NIST National Checklist Program Checklist Repository.

h. The standard installation, operation, maintenance, updating and patching of software shall not alter the configuration settings from VA approved baseline configuration. Software developed for VA must be compatible with VA enterprise installer services and install to the default “program files” directory with silently install and uninstall. The contractor shall perform testing of all updates and patching prior to implementation on VA systems.

i. Applications designed for normal end users will run in the standard user context without elevated system administration privileges.

j. The contractor-delivered solutions shall reside on VA approved operating systems. Exceptions to this will only be granted with the written approval of the COR/CO.

k. The contractor shall design, develop, and implement security and privacy controls in accordance with the provisions of VA security system development life cycle outlined in NIST 800-37, Risk Management Framework for Information Systems and Organizations: A System Life Cycle Approach for Security and Privacy, VA Directive and Handbook 6500, and VA Handbook 6517. l. The Contractor shall comply with the Privacy Act of1974 (the Act), FAR 52.224-2 Privacy Act, and VA rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish a VA function.

m. The contractor shall ensure the security of all procured or developed information systems, systems, major applications, minor applications, enclaves and platform information technologies, including their subcomponents (hereinafter referred to as “Information Systems”) throughout the…