Attachment D.1-Amarillo Statement of Work After Hours.docx

Statement of Work Pharmacy Services – After Hours Medication Order Processing

1. General The Contractor shall provide Virtual Pharmacy services to complete pending medication/supply orders (henceforth referred to as “medication orders”) for the Amarillo VA Medical Center.

This includes the professional pharmacist review and problem solving needed to assure medication orders are safe and accurate. The contractor must be a U.S. based company capable of providing pharmacy services to be completed via a secure web-based system provided by the contractor. The contractor will connect to the VA Veterans Health Information System and Technology Architecture (VISTA) computer system utilizing a Virtual Private Network (VPN) via VA Citrix Access Gateway (CAG). The contractor will have access to the VISTA Pharmacy package and electronic medical record at the Amarillo VA Medical Center. The contractor shall provide a sufficient number of licensed pharmacists to process all orders to completion.

This contract is for non-personal services. It does not create employment rights with the U.S.

Government whether actual, inherent, or implied. By agreeing to perform the services described in these specifications, the Contractor acknowledges that he/she is not, and shall not become, an employee of the U.S. Government. The Contractor further agrees that he/she shall not bring any cause of action in any forum claiming that he/she has become an employee of the U.S. Government.

This contract is a “non-personal services Contract” as defined in FAR 37.101. It is, therefore, understood and agreed that the Contractor and or the Contractor’s employees or subcontractor:

· Shall perform the services specified herein as independent Contractors, not as employees of the government.

· Shall manage and administer the work required and bear sole responsibility for complying with any and all technical, schedule, or financial requirements or constraints attendant to the performance of this Contract.

· Shall be free from supervision or control by any government employee with respect to the manner or method of performance of the services specified; but

· Shall, pursuant to the government’s right and obligation to inspect, accept, or reject the work, comply with such general direction of the Contracting Officer, or the duly authorized representative of the Contracting Officer as is necessary to ensure accomplishment of the Contract objectives.

2. OBJECTIVES

The Virtual Pharmacy Services Contractor and COR from the Amarillo VA Medical Center will work together to increase the efficiency of the Virtual Pharmacy Program, and both parties will collaborate to enhance services and increase efficiency as it relates to the delivery of medication orders.

3. REQUIREMENT/SCOPE OF WORK

3.1. VIRTUAL PHARMACY SERVICES PROVIDED BY CONTRACTOR

3.1.1. The Virtual Pharmacy Services Contractor shall provide drug knowledge resources and pharmacist medication order review and entry services as stated for the Amarillo VA medical center. The Contractor will review authorized physician medication orders that are faxed, scanned, transmitted to or accessed by the contractor during the required time periods identified in the Statement of Work. The contractor will check for medication orders in the Inpatient (including clinic medication orders and CLC orders) and/or Outpatient VISTA Pharmacy package (e.g., Inpatient Order Entry or Patient Prescription Processing, respectively) pending orders queue (Non-Verified/Pending Orders or Complete orders from OERR, respectively) every fifteen (15) minutes. After review, contractor pharmacists will process and finish/verify orders via their remote access. The contractor and the Amarillo VA Medical Center will develop a contingency plan to accommodate the verification process in the event of computer/VISTA shutdown (i.e., faxing). Calls from the Amarillo VA Medical Center will be for emergency orders and consultations. Emergency orders shall be processed within 15minutes of contact.

3.1.2. The pharmacist shall evaluate each prescription for drug-drug interactions, contraindications for recorded drug allergies, appropriate doses, accurate directions, and, as applicable, appropriate order start time to ensure the final order will be active at the appropriate time and understandable to the nurse administering or patient taking the medication. Pending medication not meeting standards for completeness, restrictions, lacking clinical information and those requiring consults shall be clarified with the prescriber prior to processing.

3.1.3. Using the VA National Formulary (VANF), which is updated monthly and accessible at http://www.pbm.va.gov/PBM/NationalFormulary.asp, the pharmacist shall review pending orders and make efforts to utilize formulary agents. If efforts are not successful, the order shall be processed, and follow-up actions will be taken by the facility.

3.1.4. The Contractor will:

i. Provide daily shift ‘sign off’ (by fax, voicemail, or web-based as agreed to by the COR at the Amarillo VA Medical Center) to include a summary of outstanding issues for follow-up by VA Pharmacy staff.

ii. Provide monthly report of activities under the contract (i.e., number of orders, number of questions answered, etc.) furnished to the Amarillo VA Medical Center. This report will be monthly and sent to the COR at the facility.

iii. Provide quarterly reports on quality improvement indicators for Amarillo VA Medical Center including:

1. Potential prescribing errors and other medication errors

2. Suspected adverse drug reactions or events

3. Information on new drugs and subsequent educational needs for VAMC staff

4. Reports will be quarterly and sent to the COR.

iv. Upon award provide policies and procedures for the virtual pharmacist services. These shall include orientation via written material and in-services, if required to the COR at the Amarillo VA Medical Center covered by this contract, involving clinical leadership, including night nursing supervisors, as well as pharmacy staff.

v. Comply with all applicable policies, rules and regulations of the Amarillo VA Medical Center of which they have been duly notified and shall not knowingly engage in any activity detrimental to the interest of the Amarillo VA Medical Center.

vi. Comply with all applicable standards of the Joint Commission including maintenance of competency training for all staff providing services to the Amarillo VA Medical Center.

vii. Complete and input all transcription notes directly into VISTA.

3.2. VIRTUAL PHARMACY SERVICES PROVIDED BY GOVERNMENT

3.2.1. Amarillo VA Medical Center will provide the following:

i. VPN Access

ii. Computer Access to VISTA Pharmacy package

iii. List of Amarillo VA contact telephone numbers

iv. Pager directory

v. List of important medical center points-of-contact; Administrative Officer of the Day (AODs); late shift on-call Pharmacist, phone numbers and pager numbers.

3.3 OPERATIONAL DAYS AND TIMES

3.3.1. Administrative Work Hours for the Amarillo VA are stated in the Price Schedule, exclusive of these holidays:

· New Year’s Day

· Martin Luther King’s Birthday

· Presidents’ Day

· Memorial Day

· Independence Day

· Labor Day

· Columbus Day

· Veterans’ Day

· Thanksgiving Day

· Christmas Day

· Any Other Day Designated a Holiday by Federal Law, Executive Order, or Presidential Proclamation

3.3.2. Clarification on the Coverage of Federal Holidays, Night Shift and Weekends

Amarillo

Federal Holidays

Start at 7:00 p.m. on the holiday and end at 7:00 a.m. the next day

• Coverage for Federal Holidays relates to the observed date of the holiday per OPM’s Federal Holiday listing at http://www.opm.gov/policy-data-oversight/snow-dismissal-procedures/federalholidays/

• Coverage Expectation

· It is the expectation of the Amarillo VA Medical Center in this contract that coverage periods that include the beginning of a Federal Holiday (i.e., passing 12AM on the Federal Holiday) follow through the usual coverage period through to its end. The required coverage periods for “Federal Holiday” for the Amarillo VA Medical Center are in regard to the start of a new coverage period beginning on the Federal Holiday.

• In contracting with the Federal Government, the vendor agrees to honor Presidential Executive Orders closing agencies (see “Presidential Closing of Agencies” at http://www.opm.gov/policydata-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay/) within the confines of the contract and that the vendor will not charge any additional fees to provide coverage for these periods as the Department of Veterans Affairs honors such Executive Orders as additional Federal Holidays and, as such, the expectation is that the vendor will honor these days as Federal Holiday coverage as well.

· However, it is the responsibility of the Amarillo VA Medical Center to notify the vendor of these Executive Order holidays to secure coverage and to specify if lesser coverage hours than the full Federal Holiday hours are preferable.

3.3.3. Unexpected Service Needs and Hourly Rate

• The vendor should offer a reasonable hourly rate to VA Medical Centers for unexpected service needs. The hourly rates for the service coverage of inpatient orders should be separate from the hourly rates for the coverage of outpatient orders. The hourly rate may be set as a base year with option years to adjust for anticipated changes in costs to the vendor. At the discretion of the vendor, rates may be offered as a flat figure depending on VAMC complexity and usual service needs.

3.4. THE JOINT COMMISSION AND OTHER SPECIAL REQUIREMENTS

3.4.1. THE JOINT COMMISSION: The Contractor will be responsible to ensure that contractor employees providing work on this contract are fully trained and completely competent to perform the required work. Although this contract does not require TJC accreditation or other regulatory requirements regarding worker competency, the contractor must perform the required work in accordance with the TJC standards. The contractor is required to provide a current performance evaluation (proficiency or competency) on each pharmacist providing services under the contract. The contractor will provide current copies of the performance evaluations at the time of contract award and annually on the anniversary date of contract award to the VA Contracting Officer, or upon request.

3.4.2. EXPECTATIONS OF CONTRACTOR:

i. The Contractor will review authorized physician medication orders at specified time periods identified in the statement of work. After review, Contractor pharmacists will process and verify orders remotely.

ii. The Contractor will provide and document a general orientation for all contractor pharmacists who provide work on this contract before commencement of work. Documentation of the orientation will be provided to the Contracting Officer. This orientation will include the following topics:

1. Fire and safety policy and procedure

2. Infection control policy and procedure

3. Emergency Preparedness/Disaster policy and procedure

iii. The VA will monitor the Contractor employees’ work to ensure contract compliance.

iv. Notwithstanding other contract requirements, upon request of the Contracting Officer, the Contractor will remove from the work site, any Contractor employee who does not comply with orientation requirements or meet competency requirements for the work being performed.

v. Where the contract does not require TJC accreditation or other regulatory body requirements, the Contractor must perform the required work IAW the TJC standards. A copy of these standards may be obtained from TJC, One renaissance Blvd., Oakbrook Terrace, IL 60181.

3.4.3. HEALTH AND HUMAN SERVICES (HHS)/OFFICE OF INSPECTOR GENERAL (OIG): To ensure that the individuals providing services under the contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the Contractor is required to check the HHS - OIG, List of excluded individuals/entities on the OIG Website www.hhs.gov/oig for each person providing services under this contract. Further, the Contractor is required to certify in its proposal that all persons listed in the Contractor’s proposal have been compared against the OIG list and are not listed. During the performance of this contract, the Contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities.

3.5 RECORDS MANAGEMENT:

3.5.1. Citations to pertinent laws, codes and regulations such as 44 U.S.C. chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

3.5.2. Contractor shall treat all deliverables under the Contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3.5.3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the Contract using Government Records.

3.5.4. 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 by the Freedom of Information Act.

3.5.5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the Contract.

3.5.6. The Government Agency owns the rights to all data/records produced as part of this Contract.

3.5.6. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this Contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

3.5.7. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of competition [draft, final, etc.].

3.5.8. No disposition of documents will be allowed without the prior written consent of the Agency Records Manager. The Agency and its Contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the Agency records schedules.

3.5.9. 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, this Contract. The Contractor (and any sub-Contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

3.6 PRIVACY POLICY TRAINING: Contractor personnel must complete VHA national Privacy Policy training or other VHA approved privacy training for Contractor furnished training that meets the requirements of the HHS Standards for Privacy of Individually-identifiable Health Information as determined by the VHA. Proof of training (e.g., training completion certificate) must be provided to the COR and the Information Security Officer at each facility (to be named upon award) for each Contractor employee providing the services under this Contract.

3.7 PROTECTED HEALTH INFORMATION (PHI): Contractor must 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.

3.8 END OF CONTRACT RESPONSIBILITY: The Contractor agrees to provide self-certification that the data destruction requirements have been met and sent to the VA Contracting Officer within 30 days of termination of the contract.

3.9 CONTRACTOR QUALITY ASSURANCE: Contractor personnel processing medication orders must have the education, training and experience appropriate to performing the scope of services needed. It is the responsibility of the Contractor to have an on-going quality assurance (QA) program consistent with the standards that will support the expectations stated in the SOW, and to resolve identified problems. The written plan shall delineate the objectives of the quality assurance activities, scope of the activities, activities for monitoring and evaluation, methods of implementation of the monitoring and evaluation activities, methods for reporting results, mechanisms for taking follow-up action and responsibilities of staff for each activity of the quality assurance program. Results of the Contractor’s QA program will be forwarded to the COR on a quarterly basis or upon request within 48 hours. The plan shall be provided with the Contractor’s proposal and a VA Pharmacist approved copy shall be included as a part of any subsequent award.

3.10 QUARTERLY REPORTS: The Contractor shall evaluate the quality of medication orders and document the findings, conclusions, recommendations and actions taken. The report shall include information on special incidents, customer satisfaction, and performance improvement. Copies of aggregated data shall be forwarded to the COR by the due date listed below.

· Data Collection Month Report Due on or Before

4. GOVERNMENT QUALITY ASSURANCE SURVEILLANCE

4.1 PERFORMANCE REQUIREMENT SUMMARY: The following Performance Requirement Summary (PRS) lists the Contract’s special requirements listed in paragraph 6, their associated performance standards, the Acceptable Quality Levels (AQL), and the methods of surveillance.

4.2. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP): The QASP will be used to document the Contractor’s performance (See Attachment D.2). The QASP includes various methods of assessing performance to ensure Contract requirements are being met.

4.3 EVALUATION OF PRS AND QASP: The PRS and QASP will be incorporated into any subsequent Contract. The Contractor will be given the opportunity to correct or address any adverse findings resulting from observations throughout the Period of Performance. Furthermore, failure to correct any major nonconformance could result in termination of the Contract for cause and/or adversely impact the Contractor’s ability to be selected for future Contracts as documented in the Contractor Performance Assessment Report System (CPARS).

Service Requirement Performance Standard AQL

1. Privacy Policy Training: Contractor personnel complete Privacy Policy Training annually 0%

2. Ordering Procedures: Medication orders will be processed in a timely manner 2%

3. Records Management: Maintain 100% accountability of all records without data breach 0%

5. Security Requirements:

VA INFORMATION AND INFORMATION SYSTEM SECURITY\PRIVACY

5.1. 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 as delineated in this contract.

5.2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

5.2.1. 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.

5.2.2. 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.

5.2.3. 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.

5.2.4. The Contractor shall not permit any employee to begin work prior to confirmation from the VA that the individual’s background investigation has been reviewed and released to the Office of Personnel Management (OPM), by the Security and Investigations Center (SIC).

5.2.5. 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.

5.2.6. 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.

5.3 VA INFORMATION CUSTODIAL LANGUAGE

5.3.1. 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).

5.3.2. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems 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.

5.3.3. 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.

5.3.4. 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.

5.3.5. 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.

5.3.6. 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.

5.3.7. 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.

5.3.8. 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.

5.3.9. 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.

5.3.10. 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.

5.3.11. 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.

5.3.12. 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 COR.

5.4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

5.4.1 Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment. A-4

5.4.2. The contractor/subcontractor shall certify to the COR 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.

5.4.3. 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.

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

5.4.5. 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.

5.4.6. 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.

5.4.7. 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.

5.4.8. 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.

5.4.9. 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.

5.4.10. 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 2 days.

5.4.11. 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.

5.5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

5.5.1. 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 COR 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.

5.5.2. 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.

5.5.3. 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.

5.5.4. 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 the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

5.5.5. 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 COR. 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.

5.5.6. 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 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.

5.5.7. 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.

5.5.8. 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 pre-approved 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.

5.6. SECURITY INCIDENT INVESTIGATION

5.6.1. 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 COR 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.

5.6.2. 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.

5.6.3. 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.

5.6.3. 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.

5.7. LIQUIDATED DAMAGES FOR DATA BREACH

5.7.1. 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.

5.7.2. 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.

5.7.3. 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 considering 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.

5.7,4. 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 100% 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.

6. TRAINING

6.1.1. 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, (See Attachment D.1) 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.]

6.1.2. The contractor shall provide to the contracting officer and/or the COR 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…