P09 SOW Reference Laboratory Testing FY25 Updated.doc

Performance of Work Statement (PWS) for Clinical/Pathology Support Services for West Texas VAHCS

SCOPE

The West Texas Veterans Affairs Health Care System (WTVAHCS) Department of Pathology & Laboratory Medicine Service (P&LMS) requires support from an external contractor for reference laboratory services. The P&LMS is requesting to place an order against one of the VA National Acquisition Center contracts under GSA Schedule 621 II to provide the Veteran patient population with quality laboratory services.

The contractor/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, contractor/reference laboratory testing to the West Texas VAHCS in accordance with the Statement of Work herein.

The contractor/reference laboratory shall provide services to include the performance of analytical testing as defined by the Laboratory’s test manual, the reporting of analytical test results and consultative services regarding selection, collection, transportation and result interpretation as required to assimilate the full scope of its laboratory operations to WTVAHCS. All requirements and provisions defined in the specifications of this statement of work will apply to any laboratory, i.e., branch, division, sub-Reference Laboratory, etc. performing reference testing on behalf of the Reference Laboratory.

WTVAHCS is requesting the contractor/reference laboratory to cover a period not to exceed 60 months beginning January 1, 2026 through December 31, 2031. Pricing shall remain constant during the 60 months and WTVAHCS makes no guarantee as to what volume of tests, if any, the reference laboratory may receive. WTVAHCS reserves the right to request additional tests other than those listed within. If additional tests are added, either by the reference laboratory or WTVAHCS, the reference laboratory will provide appropriate CPT codes for the new tests.

1. DEFINITIONS

A. Lab Advisory Committee: An individual or group of laboratory Technical Specialists and/or designees that evaluate the medical/technical/service and quality qualifications of offerors labs. During the life of the contract, this group monitors quality and service provided by the

Contractor/Reference Laboratory.

B. Special Handling/STAT: Unusual circumstances may dictate the need for a specimen to be picked up specially, run out of sequence or at a special time, or reported within a shorter than usual turnaround time. This will be referred as STAT testing and will be synonymous to special handling.

C. Contracting Officer (CO): The CO named below is responsible for the overall administration of this contract. Contractor/Reference Laboratory is advised that only the CO, acting within the scope of his/her duties/responsibilities has the authority to make changes to the contract, which affect contract prices, terms, and conditions of this contract:

West Texas VA Health Care System

Contracting Officer

6010 West Texas Blvd., West West Texas, TX 79106

D. Contracting Officer Representative (COR): A Representative of the Contracting Officer will be designated to represent the CO in furnishing technical guidance and advice under this contract. The foregoing is not to be construed as authorization to interpret or furnish advice/information to the Contractor/Reference Laboratory relative to the finical or legal aspects of the contract. Those matters are the responsibility of the CO and shall not be delegated.

E. Contractor/Reference Laboratory: The term used throughout this document will be Reference Laboratory and will be considered synonymous to Contractor.

F. Report: Is defined as a printed or electronic final copy in duplicate of laboratory testing results or host-to- host electronic transmission of test results. This report as defined by the WTVAHCS shall be received by either; computer interface, fax, and/or messenger delivery according to the published turnaround times of the Reference Laboratory. If results are telephoned the report must include the name of the individual notified of the results. Specification outlining the requirements of this computer interface including computer hardware, maintenance and supply requirements are defined in the 3. Computer Interface section of this solicitation.

2. REFERENCE LABORATORY RESPONSIBILITIES:

A. The Reference Laboratory shall maintain the minimum acceptable service, reporting systems, and quality control measures as specified herein.

B. The Reference Laboratory shall provide courier service to and from

West Texas VA Health Care System

300 Veterans Blvd

Big Spring, Texas 79720 to the Reference Laboratory’s facility along with documented hazardous material shipping and handling training to transport samples in such a manner as to ensure the integrity of the specimens from any and/or all pre-analytic processing errors as defined in their laboratory user manual, analysis reporting of analytic results, and interpretation.

1. Provide specified times for courier pickup of samples from WTVAHCS to be sent to the Reference laboratory facility; M-F during normal business hours unless specified. Exceptions will be the ten (10) Government holidays below and those holidays declared by the President of the United States on an as needed basis.

Christmas Day

2. Provide STAT testing and/or STAT courier service without added cost to the Government.

3. The Reference laboratory shall perform repeat tests at no charge to the Government if the results do not, in the Government’s requesting provider opinion:

a) Fit the clinical picture of the Veteran patient.

b) The Governments’ requesting provider/representative shall explain the conditions of the patient or any discrepancies observed.

c) Repeat testing shall be the same test originally ordered.

C. The Reference Laboratory shall provide all necessary supplies, not limited to the following:

1. Primary/secondary specimen containers and to include lids/caps for secure closure from leakage.

2. Special media or primary/secondary tubes for viral samples.

3. All supplies for specialized testing (e.g. not limited to viral studies)

4. All specialized preservatives required for specimen preservation.

5. Secondary transport bags are marked with biohazard signs/symbols as required for transportation of specimens to their laboratory.

6. Secondary Transport bags shall be of dual usage, able to house the sample within sealed closures and house the paper documents in the same bag but not in the same compartment to prevent contamination of documents through leakage of samples.

7. Requisition forms (if applicable).

8. Dry ice as required for frozen sample(s) and tertiary specimen transport containers.

9. Special instructions for collection and/or transportation.

D. The Reference Laboratory shall provide a current list of test menus and pricing.

1. A list of current testing performed and any specimen requirements for each test.

2. A current fee schedule which reflects GS pricing.

3. A list of further discounted pricing for high volume tests/testing.

4. The Reference Laboratory shall submit with this proposal a percentage discount off the specified published price list for all tests other than those detailed in the Schedule.

5. Test shall be performed as prescribed by the VA attending provider.

6. The Reference laboratory shall not introduce new medical procedures/services for specimens provided by WTVAHCS without prior recommendation to and approval of the COR or authorized laboratory representative/designee.

7. If additional tests are added, either by the Reference Laboratory or WTVAHCS, the reference laboratory will provide appropriate CPT codes for the new tests.

8. Tests shall be performed to the satisfaction of the WTVAHCS P&LMS Chief and the Contracting Officer’s Representative (COR).

9. Test menus shall include reference ranges.

10. Test menus shall clearly spell out specimen requirements per test.

11. The Reference Laboratory shall assign a specific local account representative to WTVAHCS.

12. A copy of the published price list shall be submitted and maintained throughout the life of the contract.

E. The Reference Laboratory shall permit consultation on test results by telephone as needed without cost to the Government.

F. Analyze samples with limited specialized subcontractors to which testing would be sent out.

1. Pricing shall bill to the Reference Laboratory for subcontractor’s performance.

2. Third party pricing to WTVAHCS must reflect current fee schedule

3. Tests shall be performed to the satisfaction of the WTVAHCS P&LMS Chief and the Contracting Officer’s Representative (COR).

G. The Reference Laboratory shall comply with reporting tests results within the specified time frame in accordance with the nature of the testing, following all regulatory requirements for reporting of patient results.

1. All results identified as a critical or panic value will be verbally communicated immediately (less than 24 hours) to WTVAHCS Laboratory at the time of identification. Results shall be sent via a secure interconnectivity line, in compliance with Health Portability and Accountability Act (HIPPA) guidelines.

2. Provide WTVAHCS P&LMS with a means of communication to permit immediate inquiry regarding the status of any and/or all pending tests.

a). The Reference Laboratory shall provide point(s) of contact (POC) when immediate inquiry regarding the status of a pending test(s), specimen problem inquires and problem solving at all times, including weekends and holidays, is required:

i. Person(s) name(s): _________________

ii. Telephone number: _________________

iii. Fax number: _______________________ b). The Reference laboratory shall provide names and telephone number of technical directors and pathologists available for consultation:

i. Technical Director name: _________________

ii. Telephone number: _________________

iii. Pathologist name: _________________

iv. Telephone number: _________________

H. The Reference Laboratory shall provide a quarterly quality assurance data report to include:

1. The specimen result turnaround time for ordered tests per facility location.

2. This will be defined as the date a specimen was received by the Reference Laboratory until the preliminary report was available to WTVAHCS.

3. A summary list of all testing volume and costs for each test ordered.

I. The Reference Laboratory shall be in compliance with the Health Insurance Portability and

Accountability Act (HIPAA) of 1996 (Public Law 104-191).

3. COMPUTER INTERFACE

A. The Reference Laboratory Is responsible for providing an interconnection for exchanging data between Veterans Health Information Systems and Technology Architecture (VistA) owned by VA and the Reference Laboratory’s Electronic Interchange (EDI) System or any new interface partner of the Laboratory Information System (LIS) for the purpose of delivering laboratory orders to the Reference Laboratory and to deliver the Reference Laboratory Test Results to the WTVAHCS without delay in services.

1. This interconnection shall be protected through the use of VA approved encryption algorithms and products as required.

2. Connections at each end shall be located within a controlled access facility.

3. All access shall be controlled by authentication methods to validate approved users.

B. The Reference Laboratory shall provide the following interfacing requirements:

1. LIS physical connection and translation (drivers)

2. Any required (additional) interface connection licenses(s).

3. Web-based electronic ordering and resulting

4. Provide documentation of successful interfacing with a minimum of 2 VA refences and 2 private sector, other federal agency, state or local government agencies/institutions. References to include the facility address, telephone number, email address, and contact person’s name which can validate past experience within the last three (3) years.

5. Interface shall transmit test results to the host computer via automatic upload

6. Automatic printing of laboratory results to a dedicated Reference Laboratory printer, supplied by the Reference Laboratory.

7. The implementation of the services/requirements described in this solicitation shall be completed no later than 120 days after the award of the contract. Failure to provide timely implementation may result in termination of the contract.

a). The Reference Laboratory shall furnish a schedule to show a customizable implementation plan of the required services (telecommunications, interface connectivity, validation, client service support, courier/logistics, ordering supplies, specimen processing services, reporting, quality assurance, billing, etc.)

b). The Reference Laboratory implementation plan shall be approved/acceptable to the WTVAHCS P&LMS Chief and the COR without causing extenuating delay in services or by compounding the workload by having laboratory employees manually enter in test results.

i. Manual entry of Reference Laboratory test results is considered to be a patient safety issue and is not acceptable.

ii. Manual entry of Reference Laboratory test results will add undue burden to the laboratory staff becasue of an already shortage of staff and is not acceptable.

8. Computer interface questions where information is required to update, maintain, and support the services of the host-to host linkage between WTVAHCS and the Reference Laboratory shall be addressed within two (2) hours of the initial inquiry.

9. The Reference Laboratory must have a Memorandum of Understanding or a Business

Associate Agreement established with the VA or WTVAHCS within 120 days after the contract award.

a. Transfer of data is bidirectional and will occur in the following manner:

b. The following data fields will be collected:

Prime ID

Specimen ID

Patient ID

Priority

Action code

Sample type

Collect date

Collect time

Creation date

Creation time

Last name

First name

Middle name

Sex

Birthday

Location

Reference Lab Name Station

Test name

c. Data is transferred from VISTA to a Data Innovations Secure Network Interface (SNI) device which is then sent to the instrument, using the appropriate format. Once testing is complete, the Reference Laboratory sends the result back to the SNI which then sends the result back to VISTA in the appropriate format.

d. All testing results is performed by Pathology & Laboratory Medicine Service staff using appropriate procedures, access and verify codes. VA sensitive information is stored in the VISTA/LIS database and all records are backed up on disk and stored in a secure, location, (disks in locked drawers behind locked doors) per regulations. Data will be available to providers using CPRS system.

e. The above Protected Patient Information (PPI) will stay at the Reference Laboratory’s hard drive. At the end of the contract the PPI and PHI located on the hard drive and any other data storing devices will be removed or proof that data has been destroyed from the Reference Laboratory’s computer and analyzer’s systems and be taken to IRM for disposal. Refer to Section 8, Records Management and Section 10, Privacy/ Security of VA Sensitive Information of this contract for further requests governing PHI.

4. BILLING AND INVOICING

A. Monthly billing and test report summaries shall begin on the first day of the month and include the last day of the month. A monthly invoice shall include:

1. Contract number

2. POP will be clearly documented on all invoices (Referring dates of service)

3. Patient name

4. Test name

5. Accession Number

6. CPT code

7. Number of CPT codes

8. Charge of each CPT

9. Total charge for each patient B. Services rendered will be verified by a record keeping system maintained by P&LMS and Fiscal Service’s at WTVAHCS, which assures that the VA pays for only those services actually requested and only for valid patients of WTVAHCS.

1. WTVAHCS shall not be responsible for payment of services which were not requested in Accordance with the contract.

2. WTVAHCS will NOT pay for tests that are not clearly identified by accession number on the Reference Laboratory invoice.

3. Invoices are to be separate for West Texas and Lubbock laboratories but the usage of the same PO number is acceptable for billing purposes.

C. Invoices will be electronically submitted to the Tungsten website at:

http://ww.tungsten-network.com/uk/en/

1. Tungsten direct vendor support number is 877-489-6135 for VA contracts.

2. The VA-FSC pays all associated transactions fees for VA orders. During implementation (technical set-up) Tungsten will confirm your Tax Payer ID number with the VA-FSC.

3. All invoices submitted through Tungsten to VA-FSC should mirror your current submission of Invoice.

4. VA-FSC shall require the following information in compliance with the Prompt Pay Act and Business Requirements.

a) Your Tax Payer ID number (TIN)

b) Your “Remit Address” information

c) The VA Purchase Order (PO) number

d) Your contact information: (Personal name, Email, and Phone)

e) Your VA Point of contact information (Personal name, Email, and Phone)

f) The Period of Performance dates (POP Beginning and Ending)

g) All discount information if applicable (Percent and Date Terms)

5. Department of Veterans Affairs Financial Service Center:

a) Phone:1-877-353-9791

5. REPORTING OF TEST RESULTS

A. Each test report shall at a minimum indicate the following information:

1. Clinical Laboratory Improvement Amendment (CLIA) number

2. Name of testing laboratory (contractor or subcontractor), mailing address, telephone and fax numbers

3. Case number

4. Referring physician name (if supplied)

5. Patient’s full name and/or identification code (Social security Number)

6. Medical Record number (if supplied)

7. Patient’s location (clinic/ward, if supplied)

8. Patient’s age

9. Physicians name

10. Date collected specimen collected (when available)

11. Date/time specimen received in reference lab

12. Test ordered

13. Type of specimen

14. Date testing completed

15. Test results

16. Flag abnormal test results

17. Reference range

18. Toxic and/or therapeutic range where applicable

19. Testing laboratory specimen number

20. Date reported

21. Date/time/laboratory personnel name who was called at WTVAHCS to report critical values (if applicable) less than 24 hours.

22. Any additional information the laboratory has that may indicate a questionable validity of test results.

23. Unsatisfactory specimen(s) shall be reported with data regard to its unsuitability for testing such as sample type, quantity or stability.

24. Gross Description of pathology/histology specimens.

25. Pathological diagnosis on pathology/histology specimens.

B. Telephone consultation: The Reference Laboratory shall consult with the WTVAHCS COR, requesting clinician or designee at WTVAHCS by telephone as needed.

1. The Reference laboratory shall perform pathology procedures compatible with the participating WTVAHCS operating capacity and equipment.

2. The Reference laboratory shall not introduce new medical procedures/services for specimens provided by WTVAHCS without prior recommendation to and approval of, the COR or authorized laboratory representative/designee.

C. The References Laboratory shall notify AVHCS COR or designee of instances in which, in the professional judgment of the Reference laboratory, the patient requires services /tests, which were not originally requested.

D. The Reference Laboratory shall immediately telephone the VAHCS laboratory personnel critical results or results that may indicate a life-threatening condition.

1. Phone number: 432-263-7361 ext. 7227

2. Fax number: 432-264-4859

6. QUALITY CONTROL MEASURES

A. WTVAHCS or designee shall have access during normal business hours to inspect the Reference Laboratory’s and/or any/all subcontractors facilities, equipment, and records during for the life of the contract. The results of these inspections shall be published and given to the Reference laboratory/Subcontractor.

B. Reference Laboratory shall immediately advise the COR of any changes in CPT codes, methodology, procedure, reference ranges, and any new test introduced.

C. Reference Laboratory shall provide the following information upon request during the life of the contract:

1. For quality purposes, tests routinely performed in duplicate should be indicated.

2. Indication of average monthly volume of specified tests listed in this contract.

3. Coefficient of variation of quality control samples of all tests or specified tests the Reference Laboratory performs.

4. Provide address of processing sites under contract, including subcontracted testing location sites Proficiency Testing (PT) data shall include a list of tests outside of the +/- 2SD range for the past two (2) years. The Reference Laboratory shall notify WTVAHCS COR of any test falling outside the +/- 2SD range during contract period.

5. The Reference Laboratory shall ensure that all procedures performed are of current acceptable standard deviation (SD) with at least (minimum) daily quality controls conducted to determine procedure accuracy. The SD and daily quality control records are to be available for review upon request by the CO or COR.

6. The Reference Laboratory and subcontractors’ facilities, methodologies (defined as the principle of the method and the references) and quality control procedures may be examined by WTVAHCS and/or VA designee representative(s) at any time during the of the contract after an initial pre-schedule inspection.

7. The Government may evaluate the quality of the professional and administrative services provided but retains no control over the medical professional aspects of services rendered (e.g. professional judgements and diagnosis for specific medical treatment).

7. CHANGES/CANCELATIONS

A. Any proposed subcontractor changes from what is proposed under this contract must have prior approval by the CO.

B. The Reference Laboratory shall be responsible for assuring all subcontracts have Appropriate licensure and accreditation to perform the test that the Reference Laboratory cannot perform.

C. The Reference Laboratory shall notify CO and COR of change of subcontract laboratory.

Any change shall be submitted to the CO for review and approval.

D. WTVAHCS may terminate this contract at any time upon at least 30 days written notice by the CO to the Reference laboratory.

E. The Reference laboratory, with written consent of the CO may terminate this contract upon at least 30 days written notice to the CO.

8. SAFETY/PERSONAL SECURITY VERIFICATION ACCESS

A. The Reference Laboratory shall comply will all applicable OSHA, Federal, State laws and regulations as required for performing the type of services required.

B. The performance of this contract may require the Reference Laboratory employee/representative to have routine, unescorted access to WTVAHCS facility.

1. All such employee/representative who do not already possess a current Security Badge or PIV card acceptable to VA shall be required to provide personal information, undergo and FBI National Criminal History Fingerprint Check, and obtain a Security Badge or PIV card prior to being permitted access to the facility in performance of this contract.

2. No Reference Laboratory employee/representative shall be permitted routine, unescorted access to WTVAHCS facility without proper Security Badge or PIV card.

C. WTVAHCS shall have and exercise full and complete control over granting, denying, withholding, and terminating access of the Reference Laboratory employee/representative to the facility or systems.

1. The COR will notify the Reference Laboratory immediately when WTVAHCS has determined that an employee/representative is unsuitable or unfit to be permitted access to WTVAHCS. The Reference Laboratory shall immediately notify such employee/representative that he/she no longer has access to WTVAHCS, shall retrieve the employees Security Badge or PIV card from the employee and shall provide a suitable replacement employee/representative.

2. WTVAHCS will not give the Reference Laboratory the reason for requiring the removal of the unsuitable employee/representative but can provide the applicant the phone number to call the FBI to receive a copy of the SAC report used for this determination.

3. The Government shall not be responsible for any costs incurred by the Reference Laboratory as a result of removing such employee/representative from the contract.

9. LICENSING AND ACCREDITATION

A. The Reference Laboratory shall have all licenses, permits, accreditation and certificates required by law and/or regulatory compliance. (VHA Handbook 1106.1). Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation shall be considered. The reference laboratory shall be licensed, accredited, and inspected by the Laboratory Accreditation Program (LAP) of an accrediting agency [i.e. Commission of Laboratory Accreditation (COLA), College of American Pathologists (CAP)] with deemed status from the Center for Medicare and Medicaid Services (CMS), American Associates of Blood Banks (AABB), Joint Commission (JC), Center for Disease Control (CDC), Medicare and/or other state regulatory agencies as mandated by federal and state statutes. In addition, the reference laboratory shall be certified as meeting the requirements of the Clinical Laboratory Improvement Act of 1988 and comply with the National Standards to Protect the Privacy of Personal Health Information (HIPPA).

B. The /Reference Laboratory shall be accredited by the College of American Pathologists

(CAP) and have Clinical Laboratory Improvement Amendments (CLIA) (Public Law 100-

578) certifications (VHA Handbook 1106.1

C. The Reference Laboratory must submit proof of CAP and CLIA certifications to WTVAHCS on an annual basis. (VHA Handbook 1106.1)

D. The Reference Laboratory shall be accredited by the Centers for Prevention and Disease

Control (CDC) under CLIA if Contractor/Reference Laboratory is engaged in interstate commerce. (VHA Handbook 1106.1)

E. The Reference Laboratory must submit proof of CDC certification to WTVAHCS on an annual basis. (VHA Handbook 1106.1)

F. Laboratory Director shall be a licensed America Board of Pathology certified pathologist.

The Contractor/Reference Laboratory must submit proof of certifications to WTVAHCS.

G. All personnel assigned by the Reference Laboratory to perform these testing services covered under this contract shall be licensed in a State, Territory, or Commonwealth of the

United States or the District of Columbia The Reference Laboratory must submit proof of certifications to WTVAHCS. (VHA Handbook 1106.1)

10. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE

A. 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.

B. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

1. A contractor/subcontrator shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

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.

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.

4. 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. 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.

C. VA INFORMATION CUSTODIAL LANGUAGE

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).

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 in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

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.

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. 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.

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.

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.

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.

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.

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.

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.

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 COTR.

D. SECURITY INCIDENT INVESTIGATION

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 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.

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.

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.

4. 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.

E. LIQUIDATED DAMAGES FOR DATA BREACH

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.

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.

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 in light of the degree of protection for the data, e.g., unencrypted, plain text;

(6) Amount of time the data has been out of VA control;

(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

(8) Known misuses of data containing sensitive personal information, if any;

(9) Assessment of the potential harm to the affected individuals;

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

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 $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

(3) Data breach analysis;

(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

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

F. TRAINING

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, Appendix E relating to access to VA information and information systems;

(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

2. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

3. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

11. RECORDS MANAGEMENT

A. The Reference Laboratory shall be responsible for creating, maintaining, and disposing of only those Government required records. If requested, by the WTVAHCS COR, the contractor shall provide the original record, or a reproducible copy of any such record, within two (2) business days of receipt of the request.

B. All records (administrative and program specific) created during the period/life of this contract belong the AVHCS and must be returned to AVHCS at the end of the contract.

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. West Texas VA health Care System and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of WTVAHCS 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 WTVAHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to WTVAHCS control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and WTVAHCS 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 WTVAHCS policy.

8. The Contractor shall not create or maintain any records containing any non-public WTVAHCS 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 WTVAHCS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which WTVAHCS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take WTVAHCS provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

Record Retention & Storage:

(1) Federal Records related to this policy, regardless of medium, shall be created, maintained, and dispositioned in accordance with the VHA Records Control Schedule (RCS) 10-1, General Records Schedule (GRS) or other NARA-approved records schedule, if applicable.

(2) Federal Records shall be stored per the National Archives & Records Administration (NARA) Facility Standards for Records Storage, as described in 36 Code of Federal Regulations (CFR) 1234.

References:

VHA Directive 6300, Records Management

VHA Directive 6300.01, Records Management Continuous Readiness Review and Remediation

VHA Records Control Schedule (RCS) 10-1

NARA Facility Standards for Records Storage, 36 CFR 1234

VISTA

(LIS)

DATA INNOVATIONS

REFERENCE LABORATORY