SOW FY25 Referral Lab.pdf

STATEMENT OF WORK

The purpose of this contract is to provide quality laboratory services to Veteran patients. Contractor is to provide healthcare resources in accordance with Public Law 104.262 and 38 U.S.C. 8153. Contractor agrees to provide the following laboratory procedures/tests within the current published turnaround times in support of the VA North Texas Health Care System (VANTHCS) in Dallas, Texas.

Pricing includes all labor, materials, equipment and supplies necessary to perform certain human laboratory procedures/tests. The following menu is essential but not exhaustive of the tests to be required. VANTHCS physicians may request additional types of testing beyond what is listed below. The contractor shall perform and provide results for the following tests:

Table 1:

Specialty/Test Name CPT Annual

Volume

Tissue Biopsy Consultation with or without slide processing 88321, 88332, 88323 1800

Level IV Surgical Pathology Examination 88305 40

TRANSPLANT Biopsy with Complement 4D IHC

• Heart

• Lung

• Kidney MULTIPLE 10

Necropsy – gross and microscopic brain 88027 5

Muscle/Nerve Biopsy with IHC and/or Teased Fiber Prep MULTIPLE 10

Initial single antibody stain procedure (immunofluorescence) 88346 30

Immunofluorescent study using a single antibody stain procedure – typically used in conjunction with CPT code 88346 88350 120

Initial single antibody immunohistochemistry (IHC) stain *See Table 2 for list of individual antibodies and cocktails 88342

650 Additional single antibody stain procedure 88341

Initial single probe stain procedure for in situ hybridization

(ISH)

*must include

• EBV (EBER)

• KAPPA

• LAMBDA

• HPV 88365 15

Morphometric Analysis of immunohistochemistry-stained slides *must include

• HER2 IHC stain

• PD-L1 (MULTIPLE CLONES)

• Breast Cancer Panel (ER,PR,HER2,Ki-67) 88360 30

IHC with reflex to FISH studies Must include

• HER2 Multiple 15

FACTOR V Leiden 81241 110

FACTOR II Prothrombin Mutation 81240 60

PNH 88184, 88185, 88188 15

FLOW CYTOMETRY STUDIES

Blood Tissue Bone Marrow MULTIPLE 80

Fluid

CYTOGENETICS/CHROMSOME ANALYSIS MULTIPLE 185

FLUORESCENCE IN-SITU HYBRIDIZATION (FISH) MULTIPLE 285

Table 2:

* IHC Stain CPT Codes 88342, 88341 Annual Volume = 650

Androgen Receptor (AR)

Beta- Catenin

Breast Cancer Panel (ER, PR,HER2, Ki-67)

CD56 (NCAM)

CD99 (MIC-2)

CDX2

D2-40

DOG1

E-Cadherin

Estrogen Receptor (SP1)

GATA-3

Glypican 3

Herpes 8

IgG

IgG4

Inhibin

INSM-1

Ki-67 (MIB-1)

Melanoma panel (HMB45, M2-7C10, M2-9E3)

Mismatch Repair (MMR) (MLH1, MLH2, MSH6, PMS2)

MOC-31

Myogenin

Napsin A

NKX3.1

OCT 4

p16 (INK4) p40 p504A (AMCR) -Racemase p53 p63

Pax-2

Pax-8

PIN-4 panel (AMACR, p63, HMWK)

PLAP

Progesterone receptor (PR)

PTEN

SALL4

SMAD-4

Smooth Muscle Myosin (SMM)

Smoothelin

SOX10

Syphilis

Tryptase

Villin

WT-1 (6F-H2)

WORK STATEMENT

1. Contractor shall provide laboratory services to the Pathology & Laboratory Medicine Service of the VA North

Texas Health Care System, Department of Veterans Affairs Medical Center, located at 4500 S. Lancaster Road, Dallas, Texas. Tests will be performed as prescribed by the VA attending physician.

2. VA North Texas Health Care System (VANTHCS) makes no guarantee as to what volume of tests, if any, the contractor may receive. VANTHCS reserves the right to request additional tests other than those listed within. If additional tests are added, either by the contractor or VANTHCS, the contractor will provide appropriate CPT and LOINC codes, pricing, and sample reports for the new tests. The contractor shall provide the methodology and ranges for results on any tests that are requested by representatives of

VANTHCS.

3. Only fully licensed/ CLIA-accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in the scope of work shall be considered.

4. The contractor shall provide laboratory services to include analysis, reporting of analytic results, and consultation regarding selection, collection, transportation, and result interpretation. These procedures/tests shall be performed to the satisfaction of VA North Texas Health Care System (VANTHCS) Pathology & Laboratory Medicine Service, Chief of Staff, and the Contracting Officer’s Representative (COR).

5. The contractor shall provide all labor, equipment, and materials required to perform procedures/tests as stated herein.

6. The contractor shall supply transport tubes, specimen bags, test kits, slide vessels, and collection containers as indicated. Supplies will be delivered at no charge at the request of P&LMS personnel and/or through the vendor’s inventory system.

7. Specimens submitted are human blood, body fluids, and tissue for diagnostic testing. Results are to be accessible through the contractor’s electronic database by P&LMS personnel.

8. The contractor will consult VANTHCS laboratory personnel on test results as needed.

9. Contractor shall provide VANTHCS with the methodology, ranges, and expected turnaround time for results on any tests that are requested.

10. The contractor must demonstrate how all test results shall be ordered and reported through secure methods.

11. Contractor shall maintain a searchable test database that contains the minimum information:

a. Test Name

b. Test Description

c. Test Code

d. Specimen Requirements to include:

i. Collection instructions

ii. Storage and Shipping instructions

iii. Rejection Criteria

e. Turnaround time

f. Set up day(s)

12. Contract shall cover a period from April 1, 2026, through March 31, 2031. Contract will be renewable for (4) option years. Pricing will be provided for the base year and each option year.

Base April 1, 2026, through March 1, 2027 Option 1 April 1, 2027, through March 31, 2028 Option 2 April 1, 2028, through March 31, 2029 Option 3 April 1, 2029, through March 31, 2030 Option 4 April 1, 2030, through March 31, 2031

13. These procedures/tests shall be performed to the satisfaction of Quality Assurance Surveillance Plan (QASP.

Services rendered will be verified by a record keeping system maintained by Pathology & Laboratory

Medicine Service and Fiscal Service at VANTHCS, which assures that the VA pays for only those services requested, and only for valid patients of VANTHCS.

14. The Contractor shall reimburse the facility for any costs/supplies related to tests sent to a referral laboratory when testing is not available through no fault of the facility due to reagent problems, other product issues, instrumentation failure, or other factors. The damage assessed shall be applied to the invoice in the form of a credit or deduction.

15. The Contractor recognizes that the services under this contract are vital to the Government and must be continued without interruption and that, upon contract expiration, a successor, either the Government or another contractor, may continue them. The Contractor agrees to (1) furnish phase-in training and (2) exercise its best efforts and cooperation to affect an orderly and efficient transition to a successor.

16. Security Requirements: VA Protected Health Information is provided to the vendor under this contract. This contract is to enable a HIPAA Covered Entity to provide clinical services on behalf of VA. A patient’s consent is not required (1605.1P24). The Contractor is required to secure the PHI as required by HIPAA.

SECTION B: REQUIREMENTS/SPECIFICATIONS

1. ORDERING AND REPORTING OF LAB REPORTS RESULTS: All lab results must be reported through secure methods (contractor’s secured on-line website, Data Innovations, LEDI, secure fax)

2. LAB REPORTS: All lab reports shall contain at a minimum the following information:

a. Patient's full name

b. Patient’s identification number

c. Specimen Identification Number

d. Patient’s Date of Birth

e. Physician's name (if supplied)

f. Patient's location (clinic/ward) (if supplied)

g. Test ordered

h. Date/time of specimen collection

i. Date/time test completed

j. Test result

k. Reference intervals

l. Toxic and therapeutic ranges, if applicable

m. Flagged abnormal test results

n. Reference laboratory specimen number

o. Name and address of testing laboratory

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

q. Unsatisfactory specimen shall be reported with documentation supporting its unsuitability for testing

The Contractor shall state their policy and any associated fees for repeat testing if requested by the provider.

3. TURNAROUND TIMES: The Contractor shall provide timely (defined by the minimum and maximum turnaround times detailed in the description of requirements) and appropriate testing of patient specimens as requested by VANTHCS.

a. The Contractor shall provide a list of the estimated turn-around time for any tests that require longer than 24 hours to complete.

b. The status and the results of testing are available within published timeframes and easily retrievable using varying options. Examples of these options are through a patient search, a sort by timeframe, a sort by test, a sort of incomplete tests, etc. Incomplete tests shall have an indication of the pending time until completion. Alert messages are generated when testing is delayed beyond published timeframes, when specimens require additional testing (reflex), or when specimens are cancelled due to unacceptability.

c. Reports of test results shall be immediately available upon verification of the test result. The computer must be able to print test results upon request and reprint retrospective test results according to a defined timeframe.

4. SPECIMEN IDENTIFICATION: VANTHCS will provide laboratory specimens properly collected identified with both the Patient’s Identification (as utilized by each facility) and requested tests. For those specimens that require special handling, the Contractor shall provide at no additional charge an adequate supply of specimen collection materials for such testing that is destined for the commercial reference laboratory for analysis (i.e., stabilizing tablets, ice packets, 24-hour collection container with preservatives, special collection tubes, etc.).

5. TRANSPORTATION SERVICES:

a. The Contractor shall provide means of routing specimens to testing lab at no additional cost to VANTHCS.

This service can be through a transportation service or utilizing appropriate packaging supplies to ship specimens to the testing lab. The contractor shall transport specimens in such a manner as to ensure the integrity and quality of the specimen.

b. If transportation services are provided, the Contractor will arrange for daily pickup Monday through Friday excluding National holidays from the Laboratory at Dallas VA Medical Center, 4500 S. Lancaster Rd., Dallas, TX 75216. Change in frequency of routine pickups will be negotiated between the contractor and VANTHCS. VANTHCS may exercise the right to adjust the transportation schedule with respect to the timetable and the number of daily pick-ups.

c. The Contractor shall be responsible for ensuring that all transport personnel are trained and follow the storage requirements for all laboratory specimens and that their competency is regularly assessed in appropriate safety and packaging procedures suitable to specimen type and distances transported. This shall include issues such as adherence to regulations for the transport of biohazards, use of rigid containers where appropriate, temperature control, notification procedures in case of accident or spills, etc.

d. During the term of this contract, this program may need to be updated and/or revised to comply with regulatory requirements. This documentation shall be made available to the VISN 17 facilities upon their request.

6. CUSTOMER SUPPORT: Contractor shall be responsible for providing services in between the hours of 8:00am and 4:30pm Monday through Friday excluding Federal Holidays. Federal Holidays are as follows: New Years’ Day, Martin Luther King’s Birthday, President’s Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day, and any other day specifically designated as a national holiday by the President of the United States.

Telephone inquiries are divided into four major categories with additional subcategories defining the type of inquiry and the VA minimum time expectation for meeting this service:

a. Specimen Collection

i. Routine inquiries where the reference laboratory performs the actual testing - if further clarification of the collection requirements is needed, shall be addressed at the time of the inquiry.

ii. Esoteric inquiries, where the information on availability and/or requirements of the questioned test requires further research, shall be addressed within 1 day of the initial inquiry.

b. Testing

i. Status of Ordered Testing - inquiries regarding the status of pending orders shall be addressed at the time of the inquiry.

ii. Esoteric inquiries where information is requested regarding methodology, correlation, interferences, reflex tests, etc. shall be addressed within 1 day of the initial inquiry.

c. Technical Expertise

i. Test utilization inquiries where information is required as to the most appropriate test to be ordered shall be addressed within 1 day of initial inquiry.

ii. Result interpretation inquiries shall be addressed within an appropriate timeframe.

iii. Consultative services where information is required regarding the clinical significance of test or inquiries by the provider into what is the best test to order for more effective patient care shall be addressed within an appropriate timeframe.

d. Account Follow-up

i. Account follow-up that requires information general in nature yet specific to the account, e.g. test pricing, courier service problems, specimen results discrepancy issues, equipment repair, supply ordering, etc. shall be addressed within four (4) hours of the initial inquiry.

7. TEST CONTRACTOR POINT OF CONTACT: Contractor shall assign a specific account representative to

VANTHCS. The Contractor shall provide the following point (s) of contact when immediate inquiry regarding the status of a pending test (s) is required:

a. Person (s) name (s): ____________________________________________________

b. Telephone number: ____________________________________________________

c. Fax number: _________________________________________________________

8. LICENSING AND ACCREDITATION:

e. Contractor shall be licensed, accredited, and inspected by the Laboratory Accreditation Program (LAP) of an accrediting agency [i.e., College of American Pathologists (CAP)] with deemed status from the Center for Medicare and Medicaid Services (CMS), the Nuclear Regulatory Commission, Center for Disease Control, 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).

f. Personnel assigned by the contractor to perform these services covered under this contract shall be licensed in a State, Territory or Commonwealth of the United States or the District of Columbia.

g. The Laboratory Director shall be a licensed pathologist, physician, or biologist.

h. Copies of all relevant permits, licenses and certification of the Contractor and any subcontractor of the primary Contractor if tests and/or services are sent to another facility for testing, shall be supplied. In addition, as these documents for the Contractor and subcontracted facilities are reissued for accreditation, reworded, or renewed the awarded Contractor shall supply a copy to VANTHCS annually.

9. INVOICING: Invoices must contain at a minimum the following information. The contractor shall provide this information on one original invoice:

a. Invoice number

b. Contract number

c. Proper CPT and LOINC Code

d. Unit Cost

e. Total Cost

f. Date of Service

10. Modifications to the Agreement and Orders

The services specified may be changed by a written modification to the agreement and any applicable orders.

The VA Contracting Officer will prepare the modification and, prior to becoming effective, shall be signed by both parties. Only the Contracting Officer is authorized to make commitments or issue changes that affect the price, quantity, or quality of performance under this agreement. In the event the Contractor effects any such changes at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized, and no adjustments will be made in the agreement or order pricing to cover any increase in costs as a result thereof.

a. Unilateral Modifications (signed only by the Government) include:

i. Exercising Options

ii. Administrative Changes (i.e., typos, update attachments, changes to points of contact, etc.)

b. Bilateral Modifications

i. Any other changes to the agreement (i.e., addition/removal of testing, changes to agreement’s terms and conditions, changes to test codes and descriptions, etc.)

A. Pricing:

1. This is a Firm Fixed Price (FFP) [contract type] with estimated quantities.

2. Variable Priced Tests shall not be included. They will either need to be provided with an FFP or not orderable through this agreement.

3. Pricing shall be determined and established upon award of the term of the agreement. Pricing shall not change unless it provides additional benefit for the Government.

B. Tests Quantities

1. The VA has estimated the quantity of tests that will be needed for the entirety of the contract to include option periods. Quantities may increase or decrease based on the Government’s needs. Quantities are not guaranteed.

2. All tests shall be listed in the award with established test codes and pricing.

C. New Tests:

1. New tests may be added to the contract through bilateral modification on a quarterly basis, as needed. The COR is responsible for submitting the modification requests to the Contracting Officer to add new tests or to update existing tests (descriptions, test codes, pricing, etc.)

2. New tests required between quarterly modifications will not be conducted until approved by the Contracting Officer. The Contracting Officer will evaluate new tests for price fair and reasonableness, in writing, before the testing is conducted.

3. Pricing shall not change for any test replaced due to a test code/description change.

D. Test Code/Description Changes.

1. Test codes/descriptions listed as part of the award shall not change prior to the FSS Contract being updated to reflect the change.

2. The contractor shall inform the COR and CO of any changes to test codes and descriptions due to changes in methodology or instruments. These changes will be reflected in a quarterly modification to be signed by both parties.

3. Modifications to change test codes/descriptions of tests on the award shall not happen more than once per quarter via bilateral modification.

11. GOVERNING LAW: This contract shall be governed, construed and enforced in accordance with Federal Law.

12. MARKETING: Contractor shall not advertise or use any marketing material, logos, trade names, service marks, or other material belonging to VANTHCS without the VANTHCS’ consent.

13. ORDER OF PRECEDENCE: The terms, conditions, and attachments referenced herein, including any formal written modifications thereto, constitute the complete agreement between the parties and take precedence over any other language, oral or written.

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

15. Separate appendix/addendum for the contractor if wanting to interface lab ordering/result system with

VisTA.

Post-award Contractor may provide a proposed plan to implement VistA interface including timeline and deliverables as listed below to meet the needs of VANTHCS. The Contractor shall furnish a schedule to show a customizable implementation plan of the required services (telecommunications, interface connectivity and validation, client service support, ordering, supplies, specimen processing services, reporting, quality assurance, billing, etc.).

1. If the Contractor’s test menu differs from that of the current VANTHCS VistA test menu, the contractor shall provide the information required for the initial build of tests into the VistA test database for tests performed at the reference lab. A VistA test file includes specimen collection and processing information, reference lab test code, CPT and LOINC codes, price, result template and other pertinent information specific to the test (ex. standard comments, ASR comments, etc.). Test files contain one test per file. VistA does not allow batch entries for test builds.

2. Interfacing requirements to be provided by the vendor:

Brief Summary of VistA Functionality - VistA is a public domain system to the VA whose functionality includes:

a. Management of patient information through a database,

b. Acceptance of test ordering information,

c. Transmittal of patient laboratory test results.

d. Storage and retrieval of patient laboratory test results.

(Note: VistA is very limited in its functionality.)

3. Computer interface questions where information is required to update, maintain, and support the services of the host-to-host linkage between the VA and the Contractor shall be addressed within 1 day of the initial inquiry.

4. The Contractor shall meet all Enterprise Cyber Security Infrastructure Project (ECSIP) requirements to establish an interconnection with the VA for transfer of laboratory test results directly into a VA computer system via the appropriate Laboratory Electronic Data Interchange protocol. There are three basic types of authorized connections. The ECSIP team will have the ultimate decision on which connection type is appropriate. The connection types are described below. More information can be obtained from the VA

Information Security Officer at any facility or directly from the ECSIP team. See attachment: “CHECKLIST

FOR INFORMATION SECURITY IN THE INITIATION PHASE OF ACQUISITION” from the VA HANDBOOK

6500.6 APPENDIX A which must be completed with the contractor’s quote.

External users shall be classified in one of three distinct categories: 1) client-to-site VPN, 2) site to-site VPN, or 3) Business Partner Gateways. Table 1 can be utilized in assisting users to determine which category a connection may best be identified.

1) Client-to-Site VPNs satisfy remote connectivity for small groups of external users (IE <50) that require access to VA internal resources. Non- VA users are restricted to specific internal IP addresses identified by the Contracting Officer Representative (COR). External business partners should have access to the minimum resources required to meet contractual obligations.

2) Site-to-Site VPNs are connections to external business partners, which terminate in an ECSIP gateway.

These connections will then be routed across the VA WAN to the requisite VA facility resources as defined by firewall policy.

3) Business Partner Gateways (BPGs) are connections to external business partners, which terminate at the requisite VA facility and do not traverse the VA WAN. These connections will be limited in number based on CIO requirement definitions.

Table 3: VistA Connectivity Requirement

VistA Connectivity Requirement Client-to-

Site VPN

Site-to-

Site VPN

Business

Partner

Gateway

Small Number of Users- If the number of users accounts the ISO must administer is manageable. A client-to-site connection will usually suffice.

X

Numerous Users - Having a significant number of client-to-site user accounts to manage may justify a site-to-site VPN.

X

Persistent Connection Required - The need to maintain continuous connectivity can usually be supported with a site- to-site VPN.

X X

High Bandwidth- A large volume of traffic may be a valid need to establish or maintain a Business Partner Gateway (BPG) connection (0 prevent certain traffic from traversing the VA WAN. As an example, a medical teaching University supported by a VA Hospital that sends large radiological images on a regular basis. This could have a detrimental impact on the VA WAN if that traffic traverses the WAN through a VPN connection.

X

Service Level Agreements- SLAs that guarantee specific levels of support to contracted agencies that could not be provided using a One-VA VPN may also justify a BPG connection.

X

High Availability- Availability of critical business processes, such as financial and medical applications, may justify maintaining a BPG to minimize the risk of financial and personal health data loss.

X

Sensitive Information- Every effort should be made to protect sensitive information. Although protection mechanisms are in place, there are still risks associated with transmitting sensitive data across any network, to include the VA WAN. Although the One-VA VPN satisfies this requirement, the sensitivity of the data may be such that additional precautions are warranted.

X X

Server-to-Server Connections - In most cases, a site-to-site VPN can be used to support external server connections.

X X

5. Any equipment provided by the Contractor to VA which contains a storage device such that when the device is powered down, VA sensitive data remains on it, shall be sanitized prior to removal from the VA premises, shall become the property of the Federal Government, and remain on Federal property or shall be destroyed in accordance with Department of Veterans Affairs regulations at the time of removal (device decommissioning).

Data required by the Health Insurance Portability and Accountability Account of 1996 (HIPAA) to remain on equipment located on Contractor's property shall be safeguarded in accordance with HIPAA and this information shall be destroyed in accordance with VA requirements when no longer required by HIPAA to be held by the contractor.

a. Equipment shall be able to store and retransmit records (24 hours of maximal instrument throughput) in case of interface downtime.

b. The reference laboratory shall meet VA information security and HIPPA requirements and shall be able to interface with the current or any new interface partner of the Laboratory Information System.

c. The Contractor shall have all users with VA access complete the VHA Privacy and HIPAA Training and the VA Privacy and Information Security Awareness and Rules prior to starting services.

d. The Contractor shall notify the facility Privacy Officer immediately with the list of patient names if any breach of computer security or privacy incident is accessed.

6. The Contractor shall provide the following interfacing requirements:

a. LIS physical connection and translation (drivers)

b. Any required (additional) interface connection license(s)

c. Web-based electronic ordering and resulting

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

e. Automatic printing of laboratory results to a dedicated reference lab printer, supplied by the reference lab.

16. PRIVACY

a. Contractors and any subcontractors must adhere to the provisions of Public Law 104-191, Health

Insurance Portability and Accountability Act (HIPAA) of 1996. This includes both the Privacy and Security

Rules published by the Department of Health and Human Services (HHS).

b. As required by HIPAA, HHS has promulgated rules governing the use and disclosure of protected health information by covered entities, Veterans Health Administration (VHA). In accordance with HIPAA, the contractor may be required to enter into a Business Associate Agreement (BAA) with VHA.

c. Business associates must follow VHA privacy policies and practices when applicable. All contractors and business associates must receive privacy training annually.

d. For contractors and business associates who do not have access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training, other VHA approved privacy training or contractor furnished training that meets the requirements of the HHS Standards for Privacy of Individually Identifiable Health Information as determined by VHA.

e. For contractors and business associates who are granted access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training or other VHA approved privacy training. Proof of training is required upon request.

NARA Records Management Language for Contracts (May 2017)

1. Contractor shall comply with all applicable records management laws and regulations, as well as National

Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. VA North Texas Health Care System and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VA North Texas Health Care System or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity.

Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to VA North Texas Health Care System. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the contract.

The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to VA North Texas Health Care System control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the contract. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VA North Texas Health Care System guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

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

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

System information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The VA North Texas Health Care System owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VA North Texas Health Care System shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

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

17. SECURITY REQUIREMENTS

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

i. 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.

ii. All contractors, subcontractors, and third-party servicers and associates working with

iii. VA information is subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

iv. 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.

v. 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.

vi. 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

i. 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).

ii. Records produced and utilized by the vendor are retained as required by federal, state, and local accrediting, licensing, and governing bodies or as defined by vendor management. All documents owned, received, or retained by the vendor, including patient treatment records, are subject to defined retention time periods.

iii. Per Section 2.3.5, Personnel Changes of the ISA/MOU:

A. “The parties agree to provide notification of the separation or long-term absence of their respective system owner or technical lead. In addition, both parties will provide notification of any changes in POC information. With respect to the system owner and technical lead, both parties also will provide notification of changes to user profiles, including users who resign or change job responsibilities.

B. “The responsible parties for each system are listed in Appendix A of this MOU/ISA. The appendix will be updated as necessary. Updating the appendix does not require the re-signing of this MOU/ISA by either party. It is the responsibility of each respective approving authority to ensure the timely updating of this appendix and for the notification of such changes to the alternate party within thirty (30) days of any personnel change.”

iv. 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.

v. 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.

vi. 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.

vii. 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.

viii. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed the VA’s minimum requirements. VA Configuration Guidelines are available upon request.

ix. Except for 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 to all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

x. 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.

xi. 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. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

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

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

iii. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default “program files” directory and silently install and uninstall.

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

v. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST

Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

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

vii. The contractor/subcontractor agrees to:

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

1. The Systems of Records (SOR); and

2. The design, development, or operation work that the contractor/subcontractor is to perform;

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

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

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

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

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

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

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

x. The Contractor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than 10 days.

xi. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the Contractor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the Contractor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within 30 days.

xii. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g., for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

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

i. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-

VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor’s security control procedures must be equivalent to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COTR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA’s network involving VA information must be reviewed and approved by VA prior to implementation.

ii. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA.