Q301--Intent to Sole Source - Ref Lab Testing Bridge - 550
18
Reference Laboratory Testing
STATEMENT OF STATEMENT OF WORK - REFERENCE LABORATORY TESTING
The Contractor shall provide all labor, supplies, equipment, information technology, and supervision necessary to provide reference laboratory testing services for the VA Illiana Health Care System. Reference Laboratory Testing services include but are not limited to: specimen transportation to testing laboratories, performance of testing, reporting of test results within the required timeframes. The test menu will be varied and based on the facility s needs and the test orders placed by the clinicians.
C.1 Tasks and Deliverables: The Contractor shall provide:
All necessary supplies for specimen transport, packaging, and testing
Any specialized tubes and shipping kits required for select patient testing
Courier for transportation of the specimens: The Contractor shall provide one (1) courier service pick-up Monday thru Friday and one (1) pick-up Saturday at the VA Illiana Health Care System (VAIHCS), 1900 East Main St., Danville, IL 61832, Room 127, to collect packaged laboratory specimens that are ready for transport. The courier will transport the sample to the respective contractor facility for patient testing.
Dry ice (if required)
Chain of custody forms (if required)
Specimen transport request forms
Reference laboratory testing and reporting with current reference ranges
STAT testing is available
Secured web-based portal system (preferred), Intranet LEDI system, and printer equipment
Maintain a customer support telephone service 24/7 365 days a year
Electronic and paper test menu
Pricing schedule
Shipping manifest
Provide and maintain a user-friendly public website which allows easy reference for researching test information (test number/CPT coding, patient preparation, test utility, result interpretive guidelines, etc.)
For tests not listed on public website contractor shall provide access to their database for client research test information
The Contractor shall provide routine test results to the ordering participating facility within twenty-four (24) hours following test completion, except when specimens are picked up the day before a weekend or holiday (in which case the results will be provided the following business day), unless specified by the Testing Catalog
If the facility requests, the Contractor will notify the facility immediately of any critical values or results
The Contractor shall store all blood and fluid specimens after all testing has been completed in the event repeat or add on testing for one (1) week at conditions that will maintain sample viability. Upon request, samples shall be returned to the collecting VA facility via courier at conditions that will maintain sample viability. All anatomical pathology specimens (i.e. slides, blocks, etc.) will be returned within two (2) weeks of test completion.
C.2 Reporting: Reports will consist of a minimum:
Two (2) full patient identifiers
Physician s name
Facility name
CLIA number (if requested)
Account number
Date/time specimen was collected
Date/time specimen was received
Date/time test was reported
Test ordered
Test result
Flagged abnormal results
Reference ranges
Name of testing laboratory
Type of specimen
Any additional comments related to test provided by submitting lab
Any other information the laboratory has that may indicate a questionable validity of test results
Unsatisfactory specimens shall be reported with regard to its unsuitability for testing
Once patient testing is completed; the laboratory results will be transmitted by a secured web-based portal system. Alternative methods of reporting results may include:
Transmission via the LEDI system to the VAIHCS VISTA computer system and to the printer equipment provided by the vendor that is located at the VAIHCS
Faxed to the VAIHCS
A printed copy of results will be hand delivered to the Central Receiving Office at the VAIHCS
C.3 TELECOMMUNICATIONS AND COMPUTER SERVICES:
C.3.1 The Contractor must provide capacity to order lab testing and the Government facility to receive results through a secure web-based portal. The Contractor must show that this portal meets VA requirements for encryption of sensitive patient information: FIPS-140-2. The Contractor is responsible for transmission of orders and test results and the preventive and as-needed maintenance of the system. Contractor must be available to train the facilities staff on the use of the system at each facility. An alternate method of sending orders and receiving results shall be in place in the event of system down time. A shipping manifest must be generated that identifies the specimens sent to the reference laboratory, transportation conditions, and testing ordered.
C.3.2 The Contractor must have the capabilities for an electronic interface (bi-directional) system. The Contractor must meet all Cyber Security requirements in order to establish an interconnection with the VA for transfer of test ordering details and laboratory test results directly from and into the VA computer system via the appropriate Laboratory Electronic Data Interchange (LEDI) protocol. The interface will be designed with a single data interface. The interface will allow the generation of manifests to identify the specimens to be sent to the reference lab. Upon receipt of test results, the VA staff will be able to review/validate test results before release. The Contractor will be responsible for the purchase of any licenses for middleware products such as Data Innovations and hardware for any middleware or interface structure.
C.3.3 Due to the difficulties encountered with any major reference laboratory interfacing change or upgrade, Contractor shall temporarily provide a single knowledgeable point of contact for researching correct test information, point(s) of contact for developing, testing, and implementing a client/vendor interface, and then an ongoing point of contact for troubleshooting interface problems.
C.3.4 The Contractor shall provide the following interfacing requirements: LIS physical connection and translation (drivers), any required (additional) interface connection license(s), provide documentation of successful interfacing with other VA facilities (provide two VAMC references), and the Interface must transmit test results to the host computer via automatic upload. The interface connection must be tested and verified before putting into use.
C.4 CONFORMANCE STANDARDS:
C.4.1 Contractor must maintain full compliance with applicable Federal and State regulations. All services provided under this contract must be performed in conformance with the Nation Fire Protection Agency (NFPA), Occupational Safety and Health Administration (OSHA), Health Insurance Portability and Accountability Act (HIPAA) and other applicable national, state and local regulatory agencies. Vendor must maintain Clinical Laboratory Improvement Act (CLIA) certificate of accreditation, and The Joint Commission, and/or the College of American Pathology (CAP) accreditation. A copy of the CLIA certificate must be provided to the Government.
C.4.2 Competency of Personnel: Contractor s Laboratory Director shall be a licensed American Board of Pathology certified pathologist. The Contractor shall make sure employees have current and valid professional certifications before starting work under this contract. Medical Technologists, Medical Technicians, and Cytotechnologists shall meet personnel qualifications required by CAP and CLIA guidelines. The Contractor shall maintain current licenses and certificates and provide copies of such to VA upon reasonable written request.
C.5 HOURS OF WORK:
C.5.1 Courier service for pick-up of patient samples shall be provided Monday thru Saturday. See section C.1 above. Patient testing shall be done a minimum of Monday through Friday but may include weekends if the reference site chooses to perform weekend testing. STAT testing must be an available option.
C.5.2 The eleven holidays observed by the Federal Government are New Years Day, Martin Luther King Day, President s Day, Memorial Day, Juneteenth National Independence Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day. Also, any other day declared by the President of the United States to be a national holiday.
C.6 PERIOD OF PERFORMANCE:
BASE PERIOD: 1 January 2023 through 31 December 2023
OPTION PERIOD ONE: 1 January 2024 through 30 June 2024
OPTION PERIOD TWO: 1 July 2024 through 31 December 2024
C.7 PERFORMANCE IMPROVEMENT: The contractor shall comply with the Government Performance Improvement (PI) program as applicable to Pathology and Laboratory Medicine Service (PALMS). Quality Assurance Technologists will provide a quarterly report to participating facility management teams for review. Contractor PI activities may be directed by the VA facility, VISN or VHA, as well as accreditation or licensing bodies. The Contractor shall abstract, compile and report PI data as requested by the VA. VA Data collection methodology, report format, and reporting deadlines will be defined by the participating facility. Examples of required PI activities include the VHA Performance Measures/Clinical Practice Guidelines program, and the Joint Commission ORYX or Core Measurement program. It is noted that PI activities are dynamic and subject to change, as driven by current priorities and resources. In all cases, the Contractor shall continually assess for, and act upon, clinical and administrative improvement opportunities. High priority shall be given by the contractor to the prevention of risk for the patient. The contractor shall implement process-related internal controls to prevent risk to the veteran. VA measures related to contract compliance will be identified by the COR.
C.8 TEST MENU REQUIREMENTS
Category
Description
621-200
Anatomic Pathology - Services for anatomic pathology include, but are not limited to, surgical pathology, molecular pathology, cytopathology, histology, histochemistry, hematopathology, diagnostic electron microscopy and autopsy pathology. CPT Codes include, but are not limited to, 88000-88099, 88300-88399 and 88342-88399.
621-201
Clinical Chemistry - Services for clinical chemistry include, but are not limited to, sugar (glucose), electrolytes (sodium, potassium, chloride and carbon dioxide), enzymes (CK, LD, AST, ALT), cholesterol, urea nitrogen, uric acid and blood gas testing. CPT Codes include, but are not limited to, 80048-80076 and 82000-84999.
621-202
Cytogentics - Services for cytogenetics include, but are not limited to, amniotic fluid and chorionic villus sampling for prenatal chromosome analysis; peripheral blood from patients with congenital anomalies, infertility, or other indications; and bone marrow aspirates for the diagnosis of leukemias. CPT Codes include, but are not limited to, 88230-88299.
621-203
Cytology - Services for cytology include, but are not limited to, Papanicolaou smear test (pap screen), nongynelogical body specimens (urine, sputa, body fluids, thoracentesis, paracentesis, cerebrospinal fluid, etc.), and fine needle aspirations. CPT Codes include, but are not limited to, 88104-88199.
621-204
Clinical Drugs of Abuse and Toxicology - Services for clinical drugs of abuse and toxicology include, but are not limited to, therapeutic drug monitoring, medical drug of abuse testing, comprehensive drug and poison analyses, and specialized stat testing for select toxicants. Excludes employment and forensic testing. CPT Codes include, but are not limited to, 80100-80103, 80150-80299 and 82000-84999.
621-205
Endocrinology - Services for endocrinology include, but are not limited to, pediatric and adult functional testing, adrenal cortical, water metabolism, pituitary secretion, gonad responsiveness, thyroid, pancreas, growth status, bone metabolism, endocrine uniformity, and vitamin status. CPT Codes include, but are not limited to, 82000-84999.
621-206
Hematology - Services for hematology include, but are not limited to, complete blood count, red blood count, white blood count, differential count, platelet count, coagulation (clotting) studies and hemoglobin. CPT Codes include, but are not limited to, 85002-85999.
621-207
Hemostasis - Services for hemostasis include, but are not limited to, comprehensive testing for thrombotic and bleeding disorders; plasminogen, antithrombin, and fibrinogen; protein C, protein S, and APC resistance; factor assays; inhibitor studies; von Willebrand studies; Factor VIII carrier studies; and platelet aggregation studies. CPT Codes include, but are not limited to, 85002-85999.
621-208
Immunology - Services for immunology include, but are not limited to, adult and pediatric immunodeficiency testing, neutrophil function testing, complement analysis, immunoglobulin and antibody testing/monoclonal gammopathies, cellular immunodeficiencies, molecular diagnosis of infections, pregnancy testing and rubella testing. CPT Codes include, but are not limited to, 86000-86849.
621-209
Microbiology - Services for microbiology include, but are not limited to, bacteriology (aerobic and anaerobic), antimicrobial susceptibility testing, molecular infectious disease testing, mycobacteriology, mycology, parasitology, and clinical virology. CPT Codes include, but are not limited to, 87001-87999.
621-210
Organ or Disease Oriented Panels - Services for organ or disease-oriented panels include, but are not limited to, basic metabolic panel, electrolyte panel, comprehensive metabolic panel, lipid panel, renal function panel, arthritis panel, acute hepatitis panel, hepatic function panel and general health panel. CPT Codes include, but are not limited to, 80048-80076.
621-211
Serology - Services for serology include, but are not limited to, serologic diagnosis (including bacterial, viral, mycoplasma, and parasitic infections), autoimmune testing, congenital diagnostics testing and various bacterial disease markers testing. CPT Codes include but are not limited to 86403-86593.
621-212
Urinalysis - Services for urinalysis include, but are not limited to, urine dipstick chemistry and urine microscopy. CPT Codes include, but are not
limited to, 81000-81099.
C.9 COR DESIGNATION:
C.9.1 VAIHCS: The Contracting Officer Representative (COR) is Kenneth Roach, Laboratory Manager, 1900 East Main St., Danville, IL 61832. Email address is: Kenneth.Roah@va.gov. Telephone number is 217-554-5542.
C.10 Records Management Requirements:
C.10.1 Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.Â
C.10.2 In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.Â
C.10.3 In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.Â
C.10.4 VA Illiana and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VA Illiana or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to VA Illiana. The agency must report promptly to NARA in accordance with 36 CFR 1230.
C.10.5 The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government's behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to VA Illiana control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand-carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).
C.10.6 The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VA Illiana guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.
C.10.7 The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VA policy.Â
C.10.8 The Contractor shall not create or maintain any records containing any non-public VA Illiana information that are not specifically tied to or authorized by the contract.Â
C.10.9 The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.Â
C.10.10 VA Illiana owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VA Illiana shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.
C.10.11 Training. Â All Contractor employees assigned to this contract who create, work with or otherwise handle records are required to take VA Illiana-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.Â
[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]Â
D. Â Flow down of requirements to subcontractors
C.10.12 The Contractor shall incorporate the substance of this clause, its terms, and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.Â
C.10.13 Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.
VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS
1. GENERAL
Contractors, contractor personnel, subcontractors, and subcontractor 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.
2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS
a. A contractor/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.
b. All contractors, 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 contractors 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.
c. Contract 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.
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 contractor/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.
e. The contractor 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 contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.
3. VA INFORMATION CUSTODIAL LANGUAGE
a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract 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 contractor/subcontractor's rights to use data as described in Rights in Data
- General, FAR 52.227-14(d) (1).
b. VA information should not be co-mingled, if possible, with any other data on the contractors/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 contractor 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 contractor 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.
c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives
and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.
d. The contractor/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 contract.
e. The contractor/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 contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/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.
f. If VA determines that the contractor 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 contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.
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.
h. The contractor/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.
i. The contractor/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.
j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/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 contractor/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.
k. Notwithstanding the provision above, the contractor/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 contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately
refer such court orders or other requests to the VA contracting officer for response.
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 contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.
5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE
a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/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 contractor 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 involving VA information must be reviewed and approved by VA prior to implementation.
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.
c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor 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) contractor-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.
d. The contractor/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 contractor/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. Contractor/subcontractor procedures are subject to
periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/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.
e. The contractor/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 contractor/subcontractor. The contractor/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.
f. VA prohibits the installation and use of personally-owned or contractor/subcontractorowned 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.
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 contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that
contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.
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) Vendor must accept the system without the drive;
(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
(3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.
(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;
(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
(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.
(c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed.
The ISO needs to maintain the documentation.
6. SECURITY INCIDENT INVESTIGATION
a. The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.
b. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.
c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.
d. 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 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.
7. LIQUIDATED DAMAGES FOR DATA BREACH
a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.
b. The contractor/subcontractor shall provide notice to VA of a security incident as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other
than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.
c. Each risk analysis shall address all relevant information concerning the data breach, including the following:
(1) Nature of the event (loss, theft, unauthorized access);
(2) Description of the event, including:
(a) date of occurrence;
(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;
(3) Number of individuals affected or potentially affected;
(4) Names of individuals or groups affected or potentially affected;
(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;
(6) Amount of time the data has been out of VA control;
(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);
(8) Known misuses of data containing sensitive personal information, if any;
(9) Assessment of the potential harm to the affected individuals;
(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and
(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.
d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $______ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:
(1) Notification;
(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;
(3) Data breach analysis;
(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;
(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and
(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.
8. SECURITY CONTROLS COMPLIANCE TESTING
On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-day s notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored,
or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.
9. TRAINING
a. All contractor employees and subcontractor employees requiring access to VA
information and VA information systems shall complete the following before being granted access to VA information and its systems:
(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;
(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;
(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and
(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]
b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.
c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, 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 training and documents are complete.
36C25223Q0170 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 12
11/9/22, 2:31 PM