Attachment A SOW Portland Ref Lab.docx

STATEMENT OF WORK (SOW) for Reference Laboratory Services

1. SCOPE

The VA Portland Healthcare System (VHAPORHCS) Pathology & Laboratory Medicine Service Department requires access to specialty and esoteric reference laboratory testing for tests not performed in house. This full-service reference laboratory contract will provide services required for specimen testing, interpretation, testing supplies, customer service, courier services, system interfaced lab result reporting services and verification of certification for test results. This requirement will ensure accurate and timely test results are made available to healthcare providers which will ensure high quality healthcare is provided to the Veterans at the VA Portland Health Care System.

a. The Reference Laboratory shall provide in accordance with all applicable federal, state, and local regulations, laws, and ordinances, and in accordance with the specifications outlined for accreditation certification if applicable, patient specimen testing for the specific range of referral testing within their capability.

b. Services shall include the performance of analytical testing as defined by the Laboratory's reference test manual, the reporting of analytical test results and consultative services as required assimilating the full scope of its laboratory operations to Portland VA Laboratory Services.

c. All requirements and provisions defined in the specifications of this solicitation will apply to any laboratory, i.e. branch, division, sub-contractor, etc. performing reference testing on behalf of the Reference Laboratory.

The VA Facilities will be responsible for specimen collection and will provide laboratory specimens prepared according to the Reference Laboratory's laboratory user’s manual, identified, and labeled for testing.

2. SPECIFIC TASKS

a. Reference Laboratory shall provide laboratory services to include: preanalytic processing as defined in Reference Laboratory published user’s manual; analysis, reporting of analytic results and interpretation of analytic clinical results. The number of tests requested under this contract will change throughout the life of the contract. The volumes or amounts shown in the solicitation are estimates only and impose no obligation on the VA.

The Reference Laboratory shall also provide the following support services: supplies, customer service, courier service (to include pickup of specimens and transport of specimens to its laboratory), reporting services, and verification of certification.

1) The specific test types and quantity of tests required by the Government may fluctuate drastically due to changes in health care needs, medical practices, new veteran enrollment, and VA Directives and performance measures requiring lab testing.

b. Provide all necessary supplies as defined in the laboratory user manual, to include, but not limited to the following:

1) Requisition forms or agreed computer ordering system

2) Specimen containers

3) Special instructions

4) Special media or tubes for viral samples, and supplies needed for special testing

5) All forms, including Chain of Custody forms

c. The Reference Laboratory shall provide to the VA Facilities the supplies and equipment within one (1) week of receipt of the delivery order. The VA Facilities will request replenishment of supplies from the Reference Laboratory on an as needed basis via telephone or fax. A confirmation of the order shall be supplied to the VA within 24 hours.

e. The Reference Laboratory shall have an expansive test menu with, at minimum, the testing outlined on Attachment A.

1) The VA expects the vendor to provide pricing for 100% of all tests found on attachment A, regardless of utilization.

2) The VA expects the vendor to also fill out columns G and H to identify who and where testing will be performed.

3) If it is identified that the vendor is unable to provide an equivalent to each test on Attachment A, the contracting officer and the identified, subject matter experts will work to determine if the vendor meets all needs.

4) As requirements change, additional tests may be added as new technology becomes available on the market. The scope of this IDIQ shall also include all tests under VA FSS Schedule 621 II.

f. Vendor must have a mechanism for testing requests to be placed electronically whether that is satisfied through an associated electronic interface or an online system.

3. Electronic Interface

a. The Contractor shall provide an electronic interface compatible with and fully functional within the Department of Veterans Affairs’ Oracle Electronic Health Record (EHR) environment. The Contractor is not required to establish or maintain any interface with VistA/CPRS systems. All laboratory result delivery, order transmission, and associated data exchanges shall occur solely through the Oracle EHR and any approved middleware solutions.

1.) Estimated GO live with Cerner is September 2027

b. The initial expense of the electronic message connectivity inclusive of hardware, software, middleware, encryption key license & management, Contractor interface programming, and/or GIM shall be borne by the Contractor.

c. Annual renewal of encryption key license renewal & management cost shall be borne by the Contractor for each ordering period exercised.

d. The Contractor shall be responsible for costs associated with general preventive maintenance and/or repair of the electronic message connectivity, Contractor system programming maintenance, and any encryption hardware, printers and printer(s) related supplies, and/or software failures resulting from no fault of the Government throughout the performance of the contract.

e. The Contractor shall support integration through approved VA middleware (e.g., Data Innovations Instrument Manager) as applicable to Oracle workflows. The Contractor shall provide all necessary technical specifications, validation support, and troubleshooting required to ensure successful interface implementation

f. An existing or VA Planned integration to Oracle EHR (with ATC, ATO approvals) must already exist.

g. System drivers must be compatible with Oracle EHR. The server and interface software will be owned and maintained by the Reference Laboratory.

h. The Reference Laboratory must possess a signed MOU-ISA (Memorandum of Understanding of Interconnection Security Agreement) with the VA Network and Security Operations Center (NSOC) at the time of proposal.

i. This interconnection shall be protected through the use of VA approved encryption algorithms and products as required and in compliance with HIPAA guidelines. Connections at each end shall be located within a controlled access facility. All access shall be controlled by authentication methods to validate approved users.

j. The Contractor shall provide the Government with specimen status in response to electronic and/or verbal query. Upon test completion, a formatted HL7 message containing specimen test results with Government’s assigned specimen identification shall be returned to the ordering Oracle EHR.

k. In the event the electronic communication between the Contractor’s system and the Government laboratory is disrupted, the contractor shall provide a hard copy of the test results or other remote access to results upon demand until the connectivity is restored. The hard copy results must contain all required patient demographic information, specimen identification numbers, collection date/time, ordering provider, actual test result, reporting units, reference range, and testing laboratory information as required by CLIA.

l. In the case of a failure of the automated system, the Contractor shall provide an alternate route of transmission (i.e. telephone, fax, or courier service) to the ordering VAMC and shall maintain the same time frames as the automated system.

m. The contractor shall provide the labor resources needed to establish the electronic interface capability both the Oracle EHR and the Contractor’s Information System. This includes configuring the HL7 connection and test code mapping in both Oracle EHR and the contractor’s information system for the tests listed in Attachment A. Any additional tests needed to be mapped or interfaced will be supported by the contractor.

4. DATA MANAGEMENT SYSTEM

The Contractor shall provide to the Government all necessary laboratory test parameters in insure accurate test result transmission between the Government and the Contractor’s database. The parameters for all tests in the Contractor’s database shall be kept current and be available to the Government sites throughout the performance period of the contract. Updates to the test parameter information must be provided to Government sits no less than 2 weeks prior to the implementation of any changes. The Contractor shall provide telephone access to a Contractor’s technical representative to respond to any question (s) regarding laboratory test parameter information. Required test parameters include:

1. Ordering code

2. CPT code

3. LOINC code

4. Reference Ranges

5. Reporting units of measurement

6. Test interpretation or interpretive remarks, if appropriate

7. Testing site (if not performed at the Contractor’s main laboratory facility)

8. Test methodology

9. Specimen requirements

10. Special handling requirements, if any

11. Indication whether the test is a panel/profile test, list of tests included in each panel/profile

The Contractor shall provide a data management system that meets the standard VA ISA/MOU security and connectivity requirements. Additional preferred system capabilities are as follows:

· Option for electronic test ordering accomplished through a menu that is intuitive, user friendly, and has available help screen resources is preferred. If electronic test ordering capability is not utilized, the Contractor shall provide manual test order requisitions in duplicate format with customized account information pre-printed on the requisition for the established ordering VAMC’s account.

· The system shall include access to test information with specimen requirements and other relevant information (e.g. turn-around-times, reference ranges, etc.)

· Available technical support via phone call for assistance with system issues encountered with entering test orders or retrieving other information.

· The system shall be able to indicate testing status by patient specimen testing request (e.g. pending or completed) that can be generated into a pending log report format for the purposes of tracking incomplete testing requests and ensuring all referred testing requests have been completed.

5. TESTING METHODOLOGY, REFERENCE LABORATORY REQUIREMENTS, TURN AROUND TIME and SPECIMEN HANDLING

a. Routine test results shall be reported within the specified turnaround time (TAT) which is defined from time of specimen receipt, from the vendor identified by the award, to when results are available to the Portland VA. If results will not be available within stated TAT, the vendor shall notify the Portland VA of the new estimated TAT within 12 hours of identification.

b. Testing methodology and reference ranges for a test must be defined in the Reference Laboratory user manual and/or website. Reference Laboratory shall advise the Facility on any changes in methodology, procedure, reference ranges and any new tests introduced 30 days in advance.

c. Reference Laboratory agrees to maintain the minimum acceptable service, reporting systems and quality control. Exception handling: Reference Laboratory will notify VA Facilities Laboratory Service within 12 hours of any problems identified.

d. Reference Laboratory shall notify VA Facilities of any specimen problems or discrepancies from the submitted manifest within 24 hours after shipping.

e. The VA Facilities will provide laboratory specimens prepared according to the Reference Laboratory's user’s manual, identified, and labeled for testing.

f. Critical Value test results shall be reported immediately to Portland VA by direct communication via telephone with a read back verification. Telephoned results will be confirmed with a follow-up by vendor via fax.

1) The government shall provide Reference Lab a line for direct communication of critical values as well as a fax number for confirmation of results.

g. The Reference Laboratory shall provide in accordance with all applicable federal, state, and local regulations, laws, and ordinances, and in accordance with the specifications outlined for accreditation certification if applicable, patient specimen testing for the tests listed in Attachment . All requirements and provisions defined in the specification of this solicitation will apply to any laboratory, i.e. branch, division, sub-contractor, etc. performing reference testing on behalf of the Reference Laboratory.

h. In the event new products or testing services are required, the contracting office will determine if the new products or testing services are within scope, and if they are within scope, a modification to the contract will be required to add the new products or testing services prior to beginning any of the new testing services or processes.

i. The contractor shall store all specimens as required by all applicable regulatory agencies

j. The referral laboratory will report infectious disease results of particular significance directly to the referring laboratory, P&LMS. A list of reportable infectious diseases will be supplied by P&LMS. All current local, state, and federal laws for reporting or submitting materials to public health authorities will be followed.

a. All reference laboratory testing shall be executed in accordance with standard industry practices. It is preferred that test methods are FDA approved. Any non-FDA approved method being performed shall have a disclaimer and documented validation plan.

b. Tests referred to another laboratory shall be at no additional transfer charge or confirmation charge to the government.

c. The Contractor shall notify the VA COR or designee of instances in which, in the professional judgment of the Contractor, the patient requires services or tests, which were not originally requested. No action should be taken until approval is received from the COR.

d. The Contractor shall not introduce new medical procedures and services for specimens provided by VA without prior notification to the COR, or authorized laboratory representative.

e. The Contractor shall provide in-service training required for the use of the Contractor’s test ordering and result management system. The training will ensure that Government staff is capable of performing routine test ordering and result retrieval and/or retransmission of test orders and results.

6. REPORTING OF RESULTS

A report is defined as a printed or electronic final copy of laboratory testing results. This report shall be received by remote terminal where applicable. A report is defined as an electronic final copy that is sent to the ordering laboratory using a bi-directional interface to the VA’s health information system, VistA. Copies of reports should also be made available in the contractor’s secure online portal. A report may also be a hard copy document that is faxed or mailed to the ordering laboratory. Each test report shall indicate, at minimum, the following information:

a. Patient's name and/or identification code (Social Security Number or Unique Identifier (UID), if provided)

b. Physician's name (if supplied)

c. Patient's location (clinical/ward), (if supplied)

d. Date/time specimen received in Reference Lab

e. Test ordered

f. Date/time of specimen collection (when available)

g. Date test completed

h. Test result and unit of measure, when applicable

i. Flag abnormals

j. Reference range, when applicable

k. Toxic and/or therapeutic range where applicable

l. Testing laboratory specimen number

m. Name and address of testing laboratory (contractor and/or subcontractor)

n. Type of specimen

o. Any additional comments related to test provided by submitting VA laboratories.

p. Any other information the laboratory has that may indicate a questionable validity of test results.

q. Unsatisfactory specimen shall be reported with regard to its unsuitability for testing.

7. CUSTOMER SERVICE

a. The Reference Laboratory will provide VA Laboratory with a means of communication to permit immediate inquiry regarding the status of pending tests or specimen problem, 24 hours per day, 7 days per week.

b. The Reference Laboratory shall provide names and telephone numbers of technical Directors and Pathologists available to provide information.

8. COURIER SERVICES

The Contractor shall have the capability to provide courier services for laboratory specimen transport. Courier services are not required to be active at contract start; however, the Government reserves the right to activate courier service at any time during the contract period when monthly testing volume or monthly spend reaches a level that operationally warrants courier support. Upon notification from the Government, the Contractor shall initiate courier service within 20 business days at the pricing structure established in the contract.

a. Offerors shall attest that they have the capability to provide courier services within the contract’s performance area if requested by the Government, even if such services are not required at contract start

b. When a courier system is being used, these requirements apply:

I. The contractor must transport samples in accordance with Department of Transportation (DOT) and International Air Transport Association (IATA) regulations and maintain the integrity of the samples while in transit. Transport and handling of specimens shall be in accordance with CAP GEN.40511, GEN.40512, GEN.40515, GEN.40530, GEN.40535.

II. The Reference Laboratory shall be responsible for transporting and storing specimens in such a manner as to ensure stability and integrity of the specimen where applicable. Reference Laboratory shall supply any special preservatives required for specimen preservation.

III. Packaging of Specimens for Transport: The contractor is responsible for ensuring that the samples received from the VAMCs are transported in an appropriate and controlled environment to ensure the integrity of room temperature, refrigerated, and frozen specimens, by packing them into the appropriate container type from the VAMCs/pick up locations.

IV. Reference Laboratory shall supply any special preservatives required for specimen preservation.

V. Reference Laboratory shall notify VA Facilities of any specimen problems or discrepancies from the submitted manifest within 24 hours after shipping.

VI. The Reference Laboratory shall provide routine scheduled specimen pickup at a time mutually agreed upon by the VA facilities but not less than once a day, Monday through Friday.

VII. The VA Facilities laboratory manager or designee shall notify the Reference Laboratory during weekends and federal holidays, via telephone, when a pick-up courier is required.

9. DELIVERY AND REPORTING

a. Billing summaries shall begin the first day of the month and include the last day of the month.

b. The COR will review monthly invoices submitted by the Contractor to ensure invoices accurately reflect the services performed.

c. All invoices applicable to this contract must be submitted no later than twenty (20) days after the end of the contract period. Any problems regarding unpaid invoices should be directed to the COR.

d. Tests referred to another laboratory shall be at no additional transfer charge or confirmation charge to the government.

f. Invoices rendered by the contractor to the ordering facilities for services furnished under this agreement will be invoiced in full for each month in which services were performed. All payments made under this contract will be made monthly in arrears in accordance with FAR Clause 52.212-4. No advance payments will be authorized. Invoices shall be electronically sent, using the form Tungsten/OB10 e-Invoice, to the Department of Veterans Affairs, PO Box 149971 Financial Services Center (FSC), Austin, Texas 78714-8971. For more information on how to send invoices electronically, visit http://www.ipps.fsc.va.gov.

1.) Your firm’s Taxpayer ID number (TIN) 2.) Your firm’s “Remit Address” information 3.) Contract number and VA Purchase Order (PO) number 4.) Your firm’s contact information: (Personal Name, Email, and Phone) 5.) Your VA point of contact information: (Personal Name, Email, and Phone) 6.) Date services requested 7.) Description of test(s) performed 8.) Patient Name 9.) Unit Price to include any discount information if applicable (Percent and Date Terms) 10.) Invoice will be billed as individual line items as they are listed in the price schedule.

h. Monthly invoice(s) will contain only those item numbers used for that month. Invoices not received in proper format will be returned

i. Invoice requirements and supporting documentation: any changes needed to the Supporting documentation and corrections needed to the invoice itself shall be submitted by a new revised invoice. In addition to information required for submission of a “proper” invoice in accordance with FAR 52.212-4 (g), all invoices must include all information necessary using electronic means in accordance with the policy set forth by the VA Financial Services Center, Austin, Texas (see previous paragraph).

10. PERFORMANCE MONITORING

a. At the time of contract award the Contracting Officer will appoint a Contracting Officer Representative (COR) to assist with the contract monitoring requirements. The COR or designee will monitor such items as quality of service, contractor's ability to meet TAT's, correct billing, customer service, and review of the contractor's proficiency program.

b. Contractor shall provide to the COR or designee no later than Ninety (90) days prior to the end of each contract period a proficiency report. The COR or designee shall review the proficiency results. The contractor shall maintain a minimum of 95% success rate for proficiency testing to be considered successful. Failure to achieve 95% success rate two periods in a row could be grounds for Termination for Cause.

c. The Contractor shall provide to each VAMC a cumulative (year-to-date) and monthly report of all tests received during the month from that VAMC and for all outstanding results. The summary must include the facility account number, alphabetical listing of test names, orderable test codes, and monthly test volumes for each test. The report will also include turn around statistics, cost per test (including any additional charges), and specimen or testing issues.

d. The COR or designee will ensure that services performed are in accordance with all terms and conditions of the contract.

e. The delegated COR or designee will notify the Contracting Officer of any non-compliance immediately upon his/her gaining knowledge of any such situation or incident. After such communication, the COR or designee will provide a written statement to the contracting officer along with any supporting documentation regarding the performance failure noted.

f. Upon receipt of a proper invoice, the COR or designee shall certify that the services identified have been performed. Once certification has been made, the invoice will be forward through the proper billing channels and payment shall be made to the Contractor.

g. It is the intention of both parties to conduct joint reviews prior to the expiration date of the contract to determine and evaluate if services being provided are in accordance with the contract terms, payments and billings are being properly handled and to jointly determine if this agreement is satisfactory to both parties in terms of services provided and consideration being received. This review may include. but not be limited to: analyze all billings, payments, costs, administrative issues, patient satisfaction, quality of care and other related documentation that identities that services have been received.

h. Upon conclusion of the initial contract period, and in coordination with the Contracting Officer, the using service shall provide a statement to the Contracting Officer providing a summary of contractor actions and a statement that all requirements of the contract were fulfilled as agreed. This information shall be forwarded by the COR or designee to the Contracting Officer prior to exercising any extension of this agreement (at least 60 days prior to contract expiration).

11. LICENSING AND ACCREDITATION

a. Reference Laboratory shall provide copies of all licenses, permits, accreditation and certificates required by law. Laboratory Director shall be a licensed American Board of Pathology certified pathologist or appropriately certified bio-analyst

b. The contractor must be certified and accredited by CLIA, the College of American Pathologists (CAP) and/or The Joint Commission (TJC) and licensed by other federal and/or state regulatory agencies as mandated. A copy of all relevant licensure and certifications must be provided upon award of contract and upon periodic accreditation updates for the contractor and all of their subcontractors if applicable.

c. If the awarded vendor is referring to any testing out to a 3rd party laboratory, all certifications, licenses, permits, shall also be provided by each and all laboratories performing testing for the Portland VA, upon request.

12. PERSONNEL

a. The Reference Laboratory shall make sure employees have current and valid professional certifications before starting work under this contract. This applies to the Laboratory Director,

b. The Reference Laboratory staff shall meet personnel qualifications required by Clinical Laboratory Improvement Act (CLIA) '88 Guidelines.

c. The Government’s reserves the right to request information or certification from the contractor verifying they comply with this contract requirement. If discovered the contractor is not in compliance with this requirement the contract shall be terminated for cause in accordance with clause 52.212-4.

13. SUBCONTRACTING

If during the course of the Contract, the Contractor elects to subcontract to a different laboratory for the purpose of performing any of the services required under this Contract, the Contractor shall provide advance written notification to the CO and COR. The Contractor shall be responsible for ensuring that subcontractor possess and maintain the same qualifications, accreditations and certifications as required for the Contractor as described above. The contactor will provide copies of qualifications upon request to COR or designee. The contractor is responsible for invoicing and fulfilling the terms of the Performance Work Statement. The subcontractor should not invoice for services under this contract.

14. CONFLICT OF INTEREST

Contractor is responsible for identifying and communicating to the Contracting Officer (CO) and COR conflicts of interest at the time of proposal and during the entirety of contract performance. At the time of proposal, the Contractor shall provide a statement which describes, in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided. The Contractor shall also provide statements containing the same information for any identified consultants or subcontractors who shall provide services. The Contractor must also provide relevant facts that show how it’s organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest.

15. HOURS OF OPERATION

Portland VA is open 24 hours a day, 7 days a week, 12 months of the year and may require services during those times.

16. PERIOD OF PERFORMANCE

Contract will consist of five ordering periods:

17. PATIENT INFORMATION SAFETY

a. The Reference Laboratory shall not use or disclose Protected Health Information (PHI) other than as permitted or required by the agreement or as required by law.

b. The Reference Laboratory shall use appropriate safeguards to prevent use or disclosure of the PHI other than is provided for by this agreement.

c. The Reference Laboratory shall report immediately any breach of safeguards and mitigate any harmful effects related to the use or disclosure of PHI by the Reference Laboratory or any of its agents, including sub-contractors.

18. SECURITY REQUIREMENTS

The Reference Laboratory shall be responsible for adhering to the following statements as they relate to the contract. Portland VA in coordination with their site Information Security Officer (ISO) shall monitor the work performed by contractor personnel, including sub-contractors, on a periodic basis to make sure contractor personnel are following the stated security requirements.

BACKGROUND INVESTIGATIONS AND SPECIAL AGREEMENT CHECKS

All Reference Laboratory employees are subject to the same level of investigation as VA employees who have access to VA sensitive information. The level of background investigation commensurate with the level of access needed to perform the work is: Low Risk. This requirement is applicable to all subcontractor personnel requiring the same access.

The Reference Laboratory shall bear the expense of obtaining background investigations. If the investigation is conducted by the Office of Personnel Management (OPM) through the VA, the Reference Laboratory shall reimburse the VA within 30 days.

VA INFORMATION SECURITY LANGUAGE

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.

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 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 US 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 Veteran Affairs does not have a Memorandum of Agreement with Defense Security Services (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 US 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-US services are provided and detail a security plan, deemed to be acceptable to VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the US 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.

Custody of VA Information

a. Information made available to the contractor or subcontractor by VA for the performance or administration of the contract shall be used only for the purposes and shall not be used in any other way without the written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights of Data – General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractor/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 onsite 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 the 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 VA Directive 6300, Records and Information Management and its Handbook 6300.1, Electronic Media Sanitization. Self0-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 to 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 date used by the contractor/subcontractor needs to be restored in 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 FAR Part 12.

g. In accordance with VHA DIR 1605.05, A Business Associate Agreement is not required for this contract as it falls under the treatment exemption of the HIPAA Privacy Rule.

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, the 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.

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 Contracting Officer and 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 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 date 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, 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.

Liquidated Damages for Data Breach

a. Consistent with the requirements of 38U.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 the 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 of the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the date 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 event (loss, theft, unauthorized access);

3. Number of individuals affected or potentially affected.

4. Names of individuals or groups affected or potentially affected;

5. Ease of logical date 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 date 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 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 report 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 coverage at $0 deductible; and

6. Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

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. Within 10 working day 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.

VA RECORDS MANAGEMENT OBLIGATIONS LANGUAGE

A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes VA Portland Health Care System records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their VA contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

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. The Reference Laboratory 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 the Reference Laboratory 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 COR. The VA 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 SOW. 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 are 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 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 SOW. 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 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 policy.

8. The Contractor shall not create or maintain any records containing any non-public VA 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 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.