SOW VISN 17 Coagulation-Draft.pdf

STATEMENT OF WORK

VISN 17 Coagulation Instrumentation

Purpose:

Requesting Cost per Reportable Reagent Rental Agreement for the Veterans Integrated Service Network (VISN) 17, Pathology & Laboratory Medicine Service for the purpose of performing Coagulation testing. This system must have the ability to perform FDA approved assays for the following tests and must be a fully automated, walk-away system to perform:

Required Tests Estimated VISN 17 Annual Volume (does not include calibrations/ controls)

PT 3000

PTT 1000

D-Dimer 200 PT w INR Fibrinogen

Scope:

A. Cost Per Test (CPT)

Contractor shall provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (a) equipment use, (b) all reagents, standards, controls, supplies, consumable/disposable items, parts, accessories, and any other item required for the proper operation of the Contractor's equipment and necessary for the generation and reporting of a test result, (c) all necessary maintenance to keep the equipment in good operating condition (this element includes both preventative maintenance and emergency repairs) and (d) training for Government personnel. Delivery, installation, and removal of equipment is provided at no additional charge.

B. Cost Per Reportable Result (CPRR)

Contactor shall provide a price for a reportable patient result. The per reportable result price shall include costs covering (a) equipment use, (b) all reagents, standards, controls, supplies, consumable/disposable items, parts, accessories, and any other item required for the proper operation of the Contractor's equipment and necessary for the generation 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 will 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, calibration and-correlation study testing that is prescribed by Clinical and Laboratory Standards Institute (CSLI). (c) All necessary maintenance to keep the equipment in good operating condition (this element includes both preventative maintenance and emergency repairs) and (d) training for Government personnel. Delivery, installation, and removal of equipment is provided at no additional charge.

C. VISN 17 CPT/CPRR Demand

Contractor shall ensure that items listed in Sections A and B are sufficient to meet current system demands. Tables 1-7 estimates the demand of reported patient results (note: does not include calibrations, quality control, verifications, repeats, etc.)

Estimated Demand of Tests (Volume): ALL ESTIMATES ARE NOT FINAL.

Table 1-1 - Central Texas Veterans Health Care System (CTVHCS) Analyte Temple Core Lab Austin OPC Doris Miller/Waco

PT w INR 26,000/YR 3,200/YR 1,500/YR

PTT 11,868/YR N/A N/A

FIBRINOGEN 1,300/YR N/A N/A

D-DIMER 3,500/YR N/A N/A

Table 1-2 - Amarillo VA Health Care System (AMA)

Analyte Amarillo Core Lab Lubbock Clinic PT w INR 7,000/YR 1,500/YR 1,500/YR

PTT 5,000/YR 250/YR N/A

FIBRINOGEN 50/YR N/A N/A

D-DIMER 1,000/YR N/A N/A

Table 1-3 - VA North Texas Health Care System (NTHCS)

Analyte Dallas Core Lab Fort Worth OPC Sam Rayburn OPC PT w INR 26,000/YR 3,200/YR 1,500/YR

PTT 1,000/YR N/A N/A

FIBRINOGEN 50/YR N/A N/A

D-DIMER 200/YR N/A N/A

Table 1-4 - VA Texas Valley Coastal Bend Health Care System (VCB)

Analyte Harlingen Core Lab Laredo OPC Corpus Christi OPC PT w INR 1,500/YR 1,300/YR 1,100/YR

PTT 550/YR 450/YR 150/YR

FIBRINOGEN /YR N/A N/A

D-DIMER /YR N/A N/A

Table 1-5 - South Texas Veterans Health Care System (STVHCS)

Analyte Audie L. Murphy Kerrville VA Hospital PT w INR 26,000/YR 3,200/YR 1,500/YR

PTT 11,868/YR N/A N/A

Table 1-6 - El Paso VA Health Care System (ELP)

Analyte El Paso Core Lab PT w INR 3,000/YR N/A N/A

PTT 1,000/YR N/A N/A

Table 1-7 - West Texas VA Health Care System (WTVAHCS)

Analyte Big Spring Core Lab

Kerrville VA Hospital

PT w INR 3,000/YR 3,200/YR 1,500/YR

PTT 1,000/YR N/A N/A

FIBRINOGEN N/A N/A N/A

D-DIMER 200/YR N/A N/A

Please note the above volumes are estimates only. The Contractor shall provide annual reconciliation reports to the Contracting Officer, to determine if additional tiered-pricing discounts are applicable.

D. Testing Requirements The CPT/CPRR service shall be inclusive of the following requirements:

1. System must perform automated assay-specific pre-analytical sample integrity checks.

Must detect interference from hemolysis, bilirubin or lipemia. Must detect tube-fill height issues and flag abnormal sample aspiration, prompting the user to check for clots in the sample.

2. Vendor must offer advanced lab accreditation support and quality management.

3. System must be user-friendly and have a high throughput for routine analysis of at least

120 PT/hr.

4. System must have automatic QC frequency execution.

5. System must have auto-verification and uploading of results.

6. System must have barcoded reagents.

7. System must have continuous onboard reagent-stability monitoring.

8. System must have rerun and reflex testing capabilities.

9. System must have capability for continual loading and unloading of samples and reagents with no system interruption.

10. System must have uninterrupted sample cup and waste disposal.

11. Samples must be able to be loaded from any position at any time including STAT.

12. System must follow CLSI Guidelines for true “Point-of-Reference” sampling and the use of certified plasma for calibrations.

13. System must provide fast TAT for PT testing approximately 3 minutes.

14. System must have user friendly maintenance and overdue maintenance notifications to alert the user.

15. System must be an open system compatible with most laboratory automation track systems.

16. System must have advanced quality and accreditation support tools including time, date and operator stamps for all analyzer functions and activities, full traceability of each reagent, lot, calibration, and QC performed.

17. System must have maintenance, QC, calibration, and temperature reports easily accessible to the user.

18. System must have user-specific login and password restricted access.

19. System must have electronic storage of results and easy recall of past results.

20. System shall have a data management system capable of storing quality control (QC) results and performing QC statistical analysis.

21. The vendor will provide a UPS to accommodate facility power interruption events.

22. No re-construction of existing lab space will be permitted.

23. Vendor must be able to provide a highly sensitive reagent with an ISI value of 1.0.

24. Vendor must provide reagent composes of human tissue factor for PT INR testing. The use of human tissue factor has been proven to provide greater stability than non-human factor.

25. Vendor must provide INR validate. INR validate is a set of plasmas which have an assigned target referenced back to the World Health Organization (WHO). This confirms that INRs are properly calculated when using the Geometric Mean and the reagent ISI.

E. Installation Requirements

1. Method performance/comparison shall be at the expense of the Contractor shall include linearity material and reagents and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) Standards, The Joint

Commission, and federal regulations.

2. The vendor will provide a specialist to perform method validations after the installation of the analyzer. Method validations may include but not limited to the following:

a. Correlation studies.

b. Linearity and determining the Analytic Measurement Range

c. Precision using Quality Control Material

d. Review and/or verification of common interferences with each assay.

e. Carry-over studies

3. Contractor will provide on-site training as part of installation to a minimum of 3 users.

F. Personnel Training

The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally one operator per year at the discretion of the Government. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant.

G. Technical Support

Contractor shall provide hotline support 24 hours per day, 7 days per week. Contractor shall provide service Monday — Friday, 8 a.m. — 5 p.m., for routine preventative maintenance and problem resolution. In the case of emergency maintenance, Contractor shall provide onsite field representative within 24 hours of notification. All parts, labor, and travel shall be included in the CPT/CPRR pricing.

H. Period of Performance

Test kits will be ordered as needed. This will consist of a base period, followed by four (4) one-year options, which may be exercised at the discretion of the Government.

The estimated period of performance is as follows:

Base Period: September 29, 2026, to September 28, 2027 Option Year 1: September 29, 2027, to September 28, 2028 Option Year 2: September 29, 2028, to September 28, 2029 Option Year 3: September 29, 2029, to September 28, 2030 Option Year 4: September 29, 2030, to September 28, 2031

I. Transition Contractor shall diligently work with incumbent to ensure timely transition of service, ensuring no interruption of laboratory operations or patient care. Removal of incumbent's equipment, as well as installation and setup of new Contractor's equipment shall be coordinated through the Contracting Officer and the COR

Location These supplies will be used on test systems located in VISN 17 locations.

Deliverables/Supplies

1. This order is for test system includes Test Kits and supplies.

2. The vendor will ship to VISN 17 facilities when ordered.

CLIN# Item# Description Qty/YR 1 0020013900 HemosIL Normal Control Level 1 100 2 0020014100 HemosIL High Abnormal Control Level 3 92 3 0020004200 HemosIL Low Fibrinogen Control 46 4 0020008610 HemosIL D-Dimer Control 40 5 0020003050 HemosIL RecombiPlasTin 2G, 20 84 6 0020006800 HemosIL SynthASil/CaCl 58 7 0020007700 HemosIL D-Dimer HS Reagent 58 8 0020301800 HemosIL QFA Reagent 35 9 0020302400 HemosIL Rinse Solution (4 L bottes) 530 10 0005575100 Sample cups, 2.0 mL 3 11 0002940100 Cuvette Waste Tray Liners 2 12 00027344900 Cuvette Bins 2 12 0029400100 ACL TOP Cuvettes 110 13 0009831700 HemosIL Cleaning Solution (Clean A) 324 14 0009757600 HemosIL Factor Diluent 124 15 0009832700 HemosIL Cleaning Agent (Clean B) 275 16 0020003700 HemosIL Calibration Plasma 2 17 00020301800 ACL TOP CTS filters 2

Along with the above-listed supplies and consumables, the vendor will provide all necessary maintenance to keep the testing instruments in good operating condition – including both preventive maintenance and emergency repairs – and training for government personnel in the operation of the instruments. Delivery, installation, and removal of instruments provided at no additional cost. The testing instruments for the VA North Texas Health Care System, Dallas P&LMS, 4500 S. Lancaster Rd., Dallas, TX, 75216, Fort Worth Outpatient Clinic Lab, and Sam Rayburn Memorial Veterans Center Lab.

No freight charges for reagent and supplies. One (1) fully paid Initial training slot off-site per instrument and one fully paid annual training slot per instrument to include tuition, airfare, appropriate course materials, which may be electronic media, reasonable lodging, and meals.

Work Hours and Federal Holidays Normal Work Hours: The service schedule shall be developed between the Contractor and Contracting Officer Representative (COR) prior to any service being performed.

The following is a list of U.S. Government holidays. If the holiday falls on a Saturday, the proceeding Friday is observed as the holiday; if the holiday falls on a Sunday, the following Monday is observed as the holiday and any other day specifically declared by the President of the United States to be a federal holiday.

HOLIDAY DATE

New Year’s Day January 1 Martin Luther King’s Birthday 3rd Monday in January President’s Day 3rd Monday in February Memorial Day Last Monday in May Juneteenth June 19 Independence Day July 4 Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veterans Day November 11 Thanksgiving Day 4th Thursday in November Christmas Day December 25

J. Records Management

All records (administrative and program specific) created during the period of the contract belong to VA North Texas Health Care System (VANTHCS) and must be returned to VANTHCS at the end of the contract.

K. Contractor Security Contract Requirements.

This order is for an instrument test kits and supplies; The vendor requires no access to any VA information systems. Contractor may gain remote access to instrumentation for trouble shooting purposes. None of the information in this contract includes Protected Health Information (PHI) or Individually Identifiable Information (III).

NARA Records Management Language for Contracts (May 2017)

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.

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.

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.

4. VA North Texas Health Care System 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 North Texas Health Care System 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 North Texas Health Care System. The agency must report promptly to NARA in accordance with 36 CFR 1230.

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 North Texas Health Care System 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).

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 North Texas Health Care System guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VA North Texas Health Care System policy.

8. The Contractor shall not create or maintain any records containing any non-public VA North Texas Health Care System information that are not specifically tied to or authorized by the contract.

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.

10. The VA North Texas Health Care System 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 North Texas Health Care System 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.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #10176, Privacy and Information Security, Rules of Behavior. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

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/subcontractor 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 is 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.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

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

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

c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration.

Information technology staff must also use the Windows Installer Service for installation to the default “program files” directory and silently install and uninstall.

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

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

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

g. The contractor/subcontractor agrees to:

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

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

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

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

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

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

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

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

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

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

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than _30_ days.

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within _10_ days.

l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within _60_ days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

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 vulnerability 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, and 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 / subcontractor owned equipment or software on VA’s network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA approved configuration.

Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.

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 $_37.50_ 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. 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. This User Agreement contains rights and authorizations regarding my access to and use of any information assets or resources associated with my performance of services under the contract terms with the Department of Veterans Affairs (VA).

This User Agreement covers my access to all VA data whether electronic or hard copy ("Data"), VA information systems and resources ("Systems"), and VA sites ("Sites"). This User Agreement incorporates Rules of Behavior for using VA, and other information systems and resources under the contract.

9. PRIVACY

a. Contractors and any subcontractors must adhere to the provisions of Public Law 104- 191, Health Insurance Portability and Accountability Act (HIPAA) of 1996. This includes both the Privacy and Security Rules published by the Department of Health and Human Services

(HHS).

b. As required by HIPAA, HHS has promulgated rules governing the use and disclosure of protected health information by covered entities, Veterans Health Administration (VHA).