PWS Alpha Omega DBS DRAFT.pdf

B.3 PERFORMANCE WORK STATEMENT (PWS)

ALPHA OMEGA DEEP BRAIN STIMULATION (DBS)

1. OBJECTIVE

The Department of Veterans Affairs is seeking a contractor to provide qualified Monitoring Services and support for Neurosurgery Deep Brain Stimulation (DBS) cases at the Michael E. DeBakey VA Medical Center in Houston, 2002 Holcombe Blvd, Houston, Texas 77030.

Deep brain stimulation (DBS) is a treatment for movement disorders where an electrical device is implanted to modulate brain targets, resulting in improvement.

The contractor shall provide complete monitoring services and support to include operating and maintaining equipment (including monitoring devices), supplies, and labor of on-site qualified technician to perform DBS services.

2. AGENCY BACKGROUND

a. PLACE OF PERFORMANCE:

The Michael E. DeBakey VA Medical Center (MEDVAMC) located at 2002 Holcombe Blvd, Houston, Texas 77030.

b. FACILITY ADMINISTRATIVE HOURS

Hours for the VAMC follow:

1. Administrative Hours: Monday through Friday, 8:00am to 4:30pm Local Time

2. National Holidays: The 10 holidays observed by the Federal Government are:

New Years Day;

Martin Luther King’s Birthday;

Presidents Day;

Memorial Day;

Independence Day;

Labor Day;

Columbus Day;

Veterans Day;

Thanksgiving;

Christmas; and any other day specifically declared by the President of the United States to be a national holiday.

3. SCOPE

a. SERVICES REQUIRED: Specifically, the contractor shall provide monitoring and service support of the VA owned Alpha Omega Electrophysiological Recording System for patients to assess the functional integrity of the electrodes during DBS cases in the

DRAFT

operating room or other acute care setting. This will primarily happen during neurosurgery DBS cases or for any case where the surgeon feels like the patient could benefit from this service.

b. A technician will operate the following systems:

i. Alpha Omega Electrophysiological Recording System

d. In most instances, the Contractor will be contacted at a minimum of 48 hours to reserve technician for scheduled case.

e. The services to be performed by the Contractor shall be performed in accordance with MEDVAMC policies and procedures and the regulations of the medical staff bylaws. The MEDVAMC policies and medical staff bylaws will be available upon request. These procedures shall be performed under the direction and to the satisfaction of the MEDVAMC Chief of Staff or his/her designee. The contractor will provide technicians to do real time monitoring and service of the DBS equipment in the operating room.

f. The parties agree that the Contractor, its employees, agents and subcontractors shall not be considered VA employees for any purpose.

4. GENERAL REQUIREMENTS

a. General:

i. Timeliness: Arrive on site at the MEDVAMC, 2002 Holcombe Blvd, Houston, TX 77030 in the OR, room 5A-269, Building 110 at least 60 minutes prior to surgery time.

ii. Know the general condition of the patient and the factors that affect planning for the operation prior to the operation. By communicating to the resident or surgeon 15 minutes prior to the surgery.

iii. Ensure aseptic technique is used at all times in the OR Suite.

b. Routine:

i. Maintain cleanliness and order at all times needed for cases at MEDVAMC.

iii. Prepare and calibrate equipment prior to the procedure to ensure equipment is functioning properly.

iv. Operate Alpha Omega Electrophysiological Recording System or equivalent equipment while surgery is being performed to ensure smooth functioning.

v. Clean and reassemble all equipment after each case. (per MEDVAMC Policy 118CPO-010 Cleaning and Disinfection of Non-Critical Reusable Patient Care Equipment (PCE))

c. Periodic:

i. Prepare and operate Alpha Omega Electrophysiological Recording System or equivalent and all associated equipment (every day of surgery).

ii. Calibrate Alpha Omega Electrophysiological Recording System or equivalent (every day of surgery).

iii. Report Contract Administration complications (as necessary). Respond to scheduling of urgent cases (per contract and as needed) within 8 to 12 hours. This will only occur in rare occasions.

d. Occasional: Urgent cases that consist of return to hospital to support other urgent Neurosurgery operations within 8-12 hour notice. A technician and interpreter must be available.

Again, In the past year there have been only rare occasions of urgent cases.

e. Perform patient safety measures to include:

i. Positive identification of the patient prior to services being rendered by checking at least two (2) identifiers. Specifically, the Contractor shall check the name and other identifying data and compare these with the information recorded within the Computerized Patient Record System (CPRS). Examples of acceptable identifiers include but are not limited to: patient name, date of birth, social security number, etc.

ii. Clinical monitoring of the patient, based on vital signs and baseline assessments.

iii. Ensuring completion of services related to all aspects of the Alpha Omega Electrophysiological Recording System, including initial assessment, initial education, and patient monitoring and management.

f. REPORTS: A formal report must be faxed to the performing surgeon within two days.; a formal original copy must be mailed to the performing surgeon within two weeks.

5. QUALIFICATIONS

a. The technical component of monitoring services and support shall be performed by qualified personnel.

b. Assigned contract personnel must have a minimum of two (2) years work experience operating the Alpha Omega Electrophysiological Recording System or equivalent. In addition, the Contractor shall submit evidence that the personnel assigned to work this contract routinely perform monitoring services and support at another medical institution on days not outlined in this contract.

c. Contractor shall not have personnel report to duty until written notification is received from the Contracting Officer or designee (e.g. COR) advising that the candidate(s) presented has met all requirements for contract performance.

e. REQUIRED MEDICAL CERTIFICATION: All on-site contract employees may be required to obtain "Medical Screening". All employees may be required to obtain physicals, latex screening, immunization records (including TB). Medical screening forms shall be provided at time of award (where required).

f. INSURANCE: Since this is a non-personnel service contract - the contractor is required to have their own insurance. 4.1. The Contractor shall maintain during the term of this contract medical liability insurance issued by a responsible insurance carrier of not less than the following amount(s) per specialty per occurrence: $1,000,000. 4.2. Liability insurance may be on either an occurrences basis or on a claims-made basis. If the policy is on a claims-made basis, an extended reporting endorsement (tail) for a period of not less than 3 years after the end of the contract term must also be provided.

6. RECORD KEEPING

a. For services performed at the VAMC, the following shall apply:

i. The VAMC shall establish and maintain a record keeping system that will record the hours worked and services performed by the Contractor’s employee(s) to ensure that required services have been received by the VAMC.

ii. Contractor’s employee(s) shall report to the VA Surgery Service COR or designee upon initial arrival at the VAMC.

b. Documentation of services performed shall be reviewed prior to certifying payment. The VAMC shall pay for services actually performed and in strict accordance with the price schedule and statement of work. Contract monitoring and record-keeping procedures shall be sufficient to ensure proper payment and allow audit verification that services were provided.

7. CONTRACT PERFORMANCE MONITORING

a. For services performed at the VAMC, monitoring of Contractor employee(s) time shall be demonstrated through sign-in/ sign-out sheets (hard copy or electronic). Contractor employee(s) shall be required to sign an attendance log upon reporting to work and departing from work. The COR shall be the VAMC official responsible for monitoring contract compliance. Any incidents of contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

8. QUALITY ASSURANCE SURVEILLANCE

a. This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

i. What will be monitored and serviced?

ii. How monitoring and support will take place?

iii. Who will conduct the monitoring and service?

iv. How monitoring and service support efforts and results will be documented?

b. This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance.

c. This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor through contract modification. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

d. The COR shall also receive a time and attendance report that lists each day of the month, the time they spend at the VA facility and a brief description of activities.

e. The COR may perform surveillance of services by:

i. Observing actual performance;

ii. Checking time and attendance logs;

iii. Checking OR records;

iv. Reviewing minutes of meetings;

v. Inspecting the services to determine whether or not the performance meets the performance standards; and

vi. Review of any other appropriate electronic records.

vii. Review of interpretations submitted in a timely manner.

f. As part of the surveillance plan, the COR shall review all invoices for accuracy prior to payment.

g. In all cases, surveillance shall not be so intrusive as to impact the Contractor’s successful accomplishment of the mission.

h. When unacceptable performance occurs, the COR shall inform the Contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file. When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor's program manager. The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the Contractor has to present this corrective action plan to the COR. The Government shall review the Contractor's corrective action plan to determine acceptability. Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the Contracting Officer.

i. Quality assurance monitoring documentation shall become an official Government record of the Contractor’s performance.

j. The VAMC shall establish and maintain a record keeping system that will monitor the performance of the contract provider(s). This shall be accomplished utilizing this Quality Assurance Surveillance Plan (QASP)/Checklist.

9. APPROVAL OF CONTRACTOR PERSONNEL

a. The MEDVAMC reserves the right to refuse employment under this contract or require dismissal from contract work of any contractor shall employee or subcontractor shall employee who, by reason of previous unsatisfactory performance at the VA or for any other valid reason, is considered by the Contracting Officer to be objectionable, as long as 30 days written notification of unsatisfactory performance has been provided to the Contractor; and the problem has not been cured in the 30 day period.

10. SUBCONTRACTING

a. Any subcontractor utilized by the Contractor for the provision of services required under this contract shall meet the same qualifications specified herein for the Contractor. The Contractor shall obtain approval from the Contracting Officer for any subcontractor to be utilized for the provision of services required under this contract.

11. PROTECTED HEALTH INFORMATION (PHI)

a. Contractor shall adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPPA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information.

12. PERSONAL IDENTITY VERIFICATION OF CONTRACTOR PERSONNEL

a. All personnel employed by the Contractor shall comply with Homeland Security Presidential Directive 12 (HSPD-12), Office of Management and Budget (OMB) guidance M-05-24 and Federal Information Processing Standards Publication (FIPS PUB) Number 201, which requires all federal employees, Contractor and affiliates to have a Personal Identity Verification (PIV) identification card. The PIV process shall be initiated and completed by the VA. The Contractor shall be responsible for all costs associated with transportation of the employee to the VA to initiate the fingerprinting and overall process. The COR will ensure all Stealth Navigators are informed of procedures for obtaining proper Identification cards.

13. CONTRACTOR SHALL CERTIFICATION (IMMIGRATION)

a. The Contractor shall comply with all applicable immigration laws, rules and regulations, including the Immigration and Nationality Act of 1952, as amended and shall prior to performance under this Contract execute the Contractor shall Certification incorporated herein.

14. KEY PERSONNEL

a. The Contractor shall assign to this contract the following key personnel:

List of key personnel who will be performing services under this contract. This is required for purposes of background investigations.

b. During the first ninety (90) days of this contract, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by the individual’s illness, death, or termination of employment. The Contractor shall notify the Contracting Officer, in writing, within five (5) calendar days after the occurrence of any of these events.

c. The contractor shall provide a telephone number to provide point of contact for VAMC staff.

The contractor staff assigned to answer this telephone shall act as the initial point of contact for inquiries from appropriate VAMC personnel.

d. The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the Contracting Officer. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. Any substitute personnel must be credentialed and privileged by VA in accordance with the provisions of VHA Handbook 1100.19.

The contract shall be modified to reflect any approved changes of key personnel.

e. For temporary substitutions where the key person shall not be reporting to work for three (3) consecutive work days or more, the Contractor shall provide a qualified replacement for the key person. This substitute shall have comparable qualifications to the key person. Any period exceeding two weeks will require the procedure as stated above.

15. RECORDS MANAGEMENT

a. 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.

b. 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.

Proposed Technologist/MD Name

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c. 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.

d. [Agency] 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 [Agency] 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 [Agency]. The agency must report promptly to NARA in accordance with 36 CFR 1230.

e. 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 [Agency] 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).

f. 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 [Agency] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

g. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with [Agency] policy.

h. The Contractor shall not create or maintain any records containing any non-public [Agency] information that are not specifically tied to or authorized by the contract.

i. 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.

j. The [Agency] 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 [Agency] 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.

k. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take [Agency]-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.

16. INVOICES

Contractor shall provide statements/invoices to the MEDVAMC within 30 days of end of each month services delivered. Statements/Invoices shall include patient last name and last four digits of the social security number to whom neurological monitoring services were administered, unit price and total cost for services provided.

17. BACKGROUND CHECKS

All contractor employees who require access to the Department of Veterans Affairs’ computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance.

This requirement is applicable to all subcontractor personnel requiring the same access. If the investigation is not completed prior to the start date of the contract, the contractor will be responsible for the actions of those individuals they provide to perform work for VA.

18. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

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.

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. 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: HIPAA & Privacy Training (TMS course #: 10203).

(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.

(End of Performance Work Statement) DRAFT

B.3 PERFORMANCE WORK STATEMENT (PWS)