DRAFT Performance Work Statement - Histology Lab Services.pdf

PERFORMANCE WORK STATEMENT (PWS)

HISTOLOGY TISSUE BLOCK AND SLIDE PROCESSING

SACRAMENTO VA MEDICAL CENTER, MATHER, CALIFORNIA

GENERAL

1.1. SERVICES REQUIRED:

The Department of Veterans Affairs Northern California Health Care System (VANCHCS) requires a the contractor to provide Histopathology Services to include processing, cutting, and staining slides for routine histology H&E interpretation and diagnosis by the VA. All block and slide processing will be performed at the Contractor’s laboratory facility. Services shall include providing ground courier services to pick-up formalin fixed tissue cassettes on a daily basis from the Sacramento VAMC located at 10535

Hospital Way, Mather, CA 95655. Contractor shall then transport such cassettes to Contractor’s laboratory for processing and then deliver paraffin embedded tissue blocks and processed H&E slides to the Sacramento VAMC.

1.2. PLACE OF PERFORMANCE:

Services shall be provided at the Contractor’s histology laboratory. Due to the critical nature of the tissue blocks and slides, the selected Contractor shall adhere to strict turnaround times for pick-up of tissue cassettes and delivery of processed tissue blocks and slides to the Sacramento VAMC as further defined in this Performance Work Statement (PWS). Given the short turnaround time required by the

Government, the Contractor’s histology laboratory must be located within the general vicinity of the

Sacramento VAMC such that the required turnaround times may be met without delay.

1.3. AUTHORITY: Title 38 USC 8153, Health Care Resources (HCR) Sharing Authority.

1.4. POLICY AND REGULATIONS: The Contractor shall comply with all applicable OSHA, federal, and state laws and regulations as required for performing the type of services required, including the Centers for Medicare and Medicaid Services, Clinical Laboratory Improvement Amendments (CLIA).

1.5. DEFINITIONS/ACRONYMS:

1.5.1. CAP: College of American Pathologists. Laboratory Accreditation agency that has deemed status from the Centers for Medicare & Medicaid Services.

1.5.2. CDR: Contract Discrepancy Report

1.5.3. CLIA: Clinical Laboratory Improvement Amendments. United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States.

1.5.4. CMS: Centers for Medicare and Medicaid Services

1.5.5. Contracting Officer (CO): The person executing this contract on behalf of the Government with the authority to enter into and administer contracts and make related determinations and findings.

1.5.6. Contracting Officer’s Representative (COR): A person appointed by the CO to take necessary action to ensure the Contractor performs in accordance with, and adheres to, the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken.

1.5.7. CPARS: Contractor Performance Assessment Reporting System

1.5.8. IAW: In Accordance With

1.5.9. POP: Period of Performance

1.5.10. PWS: Performance Work Statement

1.5.11. QA/QI: Quality Assurance/Quality Improvement

1.5.12. QM/PI: Quality Management/Performance Improvement

1.5.13. QASP: Quality Assurance Surveillance Plan

1.5.14. Veterans Health Administration (VHA): The central office for administration of the VA medical centers through throughout the United States. The VHA is located in Washington, D.C.

1.5.15. Veterans Integrated Services Network (VISN): The regional oversight for the VA medical center.

1.5.16. Veterans Affairs Medical Center (VAMC): Unless identified with the name of a different VA medical Center, for purposes of this contract, this term shall mean the VA Northern California Health

Care System, Sacramento VA Medical Center, 10535 Hospital Way, Mather, CA 95655.

CONTRACTOR QUALIFICATIONS

2.1. STAFF/FACILITY: The Contractor performing the work shall have a minimum of five years of experience in performing standard and specialized histology work for hospital-based histology laboratories. The Contractor must have demonstrated capability to perform routine H&E staining resulting in slides that are consistent, high quality and sufficient for making diagnoses.

2.2. LICENSING AND ACCREDITATION: Contractor shall have and maintain all licenses, permits, accreditation and certificates required by law to operate as a CLIA-certified laboratory.

2.3. CERTIFICATION: It is essential that the Contractor’s supervisory staff members are certified as

Histopathology Technicians through the American Society of Clinical Pathology (ASCP). It is preferable that staff members performing the work are also certified by ASCP. Contractor is responsible for keeping the COR apprised of anything that would adversely affect or otherwise limit their certification and ability to provide the required services. Failure to keep VA fully informed on these matters may result in the immediate termination of the contract.

2.4. PROFESSIONAL LIABILITY INSURANCE: Contractor shall maintain professional liability insurance by a commercial insurance company in the business of providing the required insurance coverage. The Contractor shall provide a copy of the Insurance Certificate upon receipt of a written request by the VA.

2.5. VARIABLE WORKLOAD: Due to the unpredictable nature of the business, the VA cannot estimate the exact number of tissue blocks that will be sent for processing on a daily basis, therefore, the

Contractor shall have the capability to accommodate variable workload (ranging from 20 tissue blocks to

200 tissue blocks daily) with minimal notice. VA will notify the Contractor in advance on the rare occasions when no tissue blocks will require processing.

2.6. CONTRACTOR’S LOCATION: The Contractor’s laboratory facilities where the tissue blocks and slides will be processed must be located within commuting distance of the Sacramento VAMC in order to allow transport of specimens to and from the Contractor’s laboratory by ground courier to ensure that the turnaround times specified in this PWS can be met.

2.7. CONFLICT OF INTEREST: Contractor is responsible for identifying and communicating to the

CO and COR conflicts of interest at the time of proposal and during the entirety of contract performance.

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

2.8. ANNUAL OFFICE OF INSPECTOR GENERAL (OIG) STATEMENT:

2.8.1. In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the VA OIG has established a list of parties and entities excluded from Federal health care programs. Specifically, the listed parties and entities may not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs.

2.8.2. Therefore, all Contractors shall review the OIG List of Excluded Individuals/Entities on the OIG web site at www.hhs.gov/oig to ensure that the proposed Contractors and/or firm(s) are not listed.

Contractors should note that any excluded individual or entity that submits a claim for reimbursement to a

Federal health care program, or causes such a claim to be submitted, may be subject to a Civil Monetary

Penalty (CMP) for each item or service furnished during a period that the person or entity was excluded and may also be subject to treble damages for the amount claimed for each item or service. CMPs may also be imposed against the Contractors and entities that employ or enter into contracts with excluded individuals or entities to provide items or services to Federal program beneficiaries.

2.8.3. By submitting their proposal, the Contractor certifies that the OIG List of Excluded

Individuals/Entities has been reviewed and that the Contractor(s) and/or firm(s) are not listed as of the date the offer/bid was signed.

SCHEDULE

3.1. SCHEDULE: The Contractor shall provide services Monday through Friday, excluding federal holidays. All services shall be provided within the timeframes specified herein.

3.2. FEDERAL HOLIDAYS: The following holidays are observed by the Department of Veterans

Affairs:

3.2.1. New Year’s Day

3.2.2. Martin Luther King’s Birthday

3.2.3. Presidents Day

3.2.4. Memorial Day

3.2.5. Juneteenth National Independence Day

3.2.6. Independence Day

3.2.7. Labor Day

3.2.8. Columbus Day

3.2.9. Veterans Day

3.2.10. Thanksgiving Day

3.2.11. Christmas Day

3.2.12. Any day specifically declared by the President of the United States to be a national holiday.

3.3. CANCELLATION POLICY: Unless a state of emergency has been declared or the VAMC is closed, the Contractor shall be responsible for providing services. If the VAMC is closed for any reason, the Contractor will be notified.

CONTRACTOR RESPONSIBILITIES

4.1. SERVICES REQUIRED: The VAMC requires a contractor to provide Histopathology Services to include processing, cutting, and staining slides for routine histology hematoxylin and eosin (H&E) interpretation and diagnosis. Services shall include providing ground courier services to pick-up formalin fixed tissue cassettes on a daily basis from the VAMC located at 10535 Hospital Way, Mather, CA

95655. Contractor shall then transport such cassettes to Contractor’s laboratory for processing; and provide ground courier services to return the resultant paraffin embedded tissue blocks and H&E stained slides to the VAMC.

4.2. STANDARDS OF PRACTICE: Contractor shall perform services according to the requirements contained in this PWS and services shall be performed in a manner that is equal to or greater than CLIA and CAP standards.

4.3. SPECIFIC CONTRACTOR TASKS

4.3.1. Pick-up Tissue Cassettes to be Processed: Contractor shall pick-up tissue cassettes from the

VAMC, Histology Laboratory on a daily basis, Monday through Friday, excluding federal holidays.

Tissue cassettes will be picked up by ground courier service no earlier than 5:00 pm and no later than

6:00 pm.

4.3.2. Deliver Processed Tissue Blocks and Slides: Contractor shall deliver processed tissue blocks and slides to the VAMC via ground courier service, Monday through Friday, as soon as the tissue blocks and slides have been processed for readout. Such deliveries shall be made no later than 11:00 am on the morning after the tissue cassettes were picked-up for processing. On days where a heavy workload is experienced (for example, Contractor picks up >50 blocks), a second delivery may be deemed acceptable by the VAMC, however, the processed tissue blocks and slides must be delivered no later than 12:30 p.m.

In cases where a second delivery is necessary, the Contractor shall include a written notification with the initial delivery indicating that a second delivery will follow.

4.3.3. Labeling of Specimens: For tracking and documentation purposes, all specimens provided to the

Contractor for processing will contain a unique log number assigned by the VAMC, Histology

Department. Sequential numbers will be utilized for specimens containing multiple blocks. Specimens processed by the Contractor, as well as documentation accompanying specimens to be processed, will be void of patient identifiers.

4.3.4. Tracking Mechanism: Each batch of specimens picked-up by the Contractor will be accompanied by a tracking log which will identify the unique specimen numbers(s); the time the specimens were picked-up or delivered; and the name of the Contractor’s courier. After processing, specimens delivered to the VAMC will be accompanied by the same tracking log, indicating the same information along with any problems encountered by the Contractor in performing the services.

4.3.5. Handling of Specimens: Specimens shall be transported and handled by the Contractor’s courier in a timely and proper manner in order to preserve the integrity of the specimen (i.e., no temperature extremes, etc.) at all times. Following pick-up of specimens from the VAMC, specimens shall be delivered directly to the Contractor’s laboratory. The Contractor may include the VAMC as part of a pick-up or delivery route that includes other hospitals provided that the final destination is the

Contractor’s laboratory and all specimens are handled properly throughout the route.

4.3.6. Upon arrival at the Contractor’s laboratory, specimens shall be processed in a timely manner according to standard histological procedures used in hospital-based histology laboratories and in accordance with regulatory requirements.

4.3.7. Slides shall be processed in a uniform manner to ensure consistency in patient testing. The

Contractor shall ensure the highest level of quality for all specimens processed and adhere to the following quality standards and practices:

4.3.7.1. Processing and Embedding: The tissue processing and embedding must produce a block free of unacceptable artifacts such as shrinking, tissue drop-out, fracturing, or over drying.

4.3.7.2. Cutting of levels on microtome: The manner in which the blocks are prepared for cutting on the microtome must minimize freezing artifacts, and when levels are cut they should be free of nicks, “chatter”, and tissue condensation. In addition, each level should be of the same thickness.

4.3.7.3. Drying: Drying of the slides shall not result in burning of the tissue.

4.3.7.4. Staining: The staining protocol used by the Contractor must provide differential H&E staining of a quality and consistency that produces well delineated, crisp results that facilitate accurate diagnosis by VA pathology staff. Contractor shall ensure that its protocol does not result in overstaining or light or washed-out staining. For example, overstaining will result in lack of nuclear detail, poor nuclear/cytoplasmic contrast, or cytoplasmic detail that is masked. Light or washed-out staining will result in nuclei that are not crisp or poor nuclear/cytoplasmic contrast.

4.3.7.5. Levels: Each individual level should have no less than 50 microns between successive levels.

4.3.8. Contractor shall process specimen blocks to include cutting and staining as follows:

4.3.8.1. Large resection cases (e.g. prostatectomy, hysterectomy, turp): One slide per block, to include any and all inked margins present, containing at least one level of tissue.

4.3.8.2. Skin shaves/punch biopsies: At least three levels of tissue. More than one slide may be required.

4.3.8.3. GI, ENT, GYN, TURBT: No less than two levels. If the Contractor routinely does 3 levels, that is acceptable, only if all three levels fit on one slide.

4.3.8.4. Prostate needle biopsies: A total of four levels on two slides, with two levels on each slide.

4.3.8.5. Skin excisions:

4.3.8.5.1. Tips should have no less than three levels on one slide, making sure to contain all inked margins and a full epidermis (tips are generally identifiable by their three-dimensional triangular shape).

4.3.8.5.2. Main part of the specimen: at least one level per block. One level will be acceptable if all ink and epidermal surfaces are present.

4.4. PERFORMANCE STANDARDS, QUALITY ASSURANCE AND QUALITY

IMPROVEMENT

4.4.1. The Contractor shall be subject to Quality Assurance measures, using the standards as outlined in this PWS and methods of surveillance detailed in the Quality Assurance Surveillance Plan (QASP). The

QASP shall be attached to the resultant contract and shall define the methods and frequency of surveillance conducted.

4.4.2. The Government will evaluate the Contractor’s performance to ensure services are performed in accordance with this Contract to include inspecting each slide processed by the Contractor or its personnel. If any of the services do not conform to the contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no additional cost to the Government. When the defective services cannot be corrected by re-performance, the Government may:

4.4.3. Obtain the service from another source and charge the Contractor with any resultant charges plus actual administrative costs.

4.4.4. Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements; and

4.4.5. Take other actions as appropriate, including but not limited to termination of this Contract.

4.4.6. For contracts with a period of one year or less, the CO will perform a single evaluation when the contract is complete. For contracts exceeding one year, the CO will evaluate the Contractor’s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the Contractor’s designated representative for comment. The Contractor will have sixty (60) days to submit any comments and re-assign the report to the CO.

4.4.7. Failure of the Contractor to respond to the evaluation within those sixty (60) days, will result in the Government’s evaluation being placed on file in the database with a statement that the Contractor failed to respond; the Contractor’s representative will be “locked out” of the evaluation and may no longer send comments.

GOVERNMENT RESPONSIBILITIES

5.1. OVERSIGHT OF SERVICE/PERFORMANCE MONITORING: After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to:

5.1.1. Network Contracting Office 21 Contracting Officer

5.1.2. Appointed Contracting Officer’s Representatives

5.2. CO RESPONSIBILITIES:

5.2.1. The CO is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the CO on all matters pertaining to contract administration. Only the CO is authorized to make commitments or issue any modification to include (but not limited to) terms affecting price, quantity or quality of performance of this contract.

5.2.2. The CO shall resolve complaints concerning Contractor relations with the Government employees or patients. The CO is final authority on validating complaints. In the event the Contractor effects any such change at the direction of any person other than the CO without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof.

5.2.3. In the event that contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, to include but not limited to a targeted and time limited performance improvement plan; increased monitoring of the contracted services; consultation or training for Contractor personnel to be provided by the VA; replacement of the contract personnel and/or renegotiation of the contract terms or termination of the contract.

5.3. COR Responsibilities:

5.3.1. After contract award, the CO will designate a VA employee as the Contracting Officer’s

Representative (COR). The COR will be responsible for overseeing the services performed by under this

Contract. The COR shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of Contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the CO.

5.3.2. The COR will certify monthly invoices for payment and will be responsible for monitoring the

Contractor’s performance to ensure all specifications and requirements are fulfilled.

IDENTIFICATION AND PARKING, SMOKING AND VA REGULATIONS

6.1. Contractor personnel shall wear visible identification at all times while on the premises of the

VAMC. All personnel entering the VA facility may have to consent to inspection of all categories of packages as a condition of admittance.

6.2. Upon contract award, the COR will provide instructions to the Contractor on where Contractor personnel should park when making pick-ups and deliveries. It is the responsibility of Contractor personnel to park in the appropriate designated parking areas. Violations of VA parking regulations may result in a citation answerable in the U.S. Federal District Court. VA will not invalidate or make reimbursement for parking violations under any conditions.

SPECIAL CONTRACT REQUIREMENTS

7.1. DELIVERY DELAYS

7.1.1. If for any reason, there will be a delay in delivery of the processed tissue blocks and slides to the

VAMC Histology Department, the Contractor will contact the VA as soon as they are aware that a delay will occur. Such notification must be made by telephone to Pathology staff and the Contractor will provide an estimated time for delivery of delayed tissue blocks and slides. Email notification will not be accepted. Upon contract award, the COR will provide the Contractor with a list of names and contact numbers for making such notifications.

7.2. BILLING/INVOICES:

7.2.1. The VAMC will maintain a record-keeping system comprising daily logs of tissue blocks and slides provided to the Contractor for processing (cutting and staining). The COR will review this data against monthly invoices submitted by the Contractor to ensure invoices accurately reflect the services performed.

7.2.2. Payment made during all periods of performance of this agreement shall constitute the total cost for services rendered by the contractor, and shall not exceed the amounts specified in the “Schedule of

Supplies and Services” without written request and the written approval from the CO.

7.2.3. Invoices rendered by the contractor to VANCHCS for services furnished under this agreement, will be invoiced in full for each month in which services were performed. All payments made under this contract will be made monthly in arrears in accordance with FAR Clause 52.212-4. No advance payments will be authorized. Invoices shall be electronically sent, using the form Tungsten/OB10 e-Invoice, to the

Department of Veterans Affairs, PO Box 149971 Financial Services Center (FSC), Austin, Texas 78714-

8971. For more information on how to send invoices electronically, visit http://www.ipps.fsc.va.gov.

7.2.4. All invoices applicable to this agreement must be submitted no later than thirty (30) days after the end of the contract period. Any problems regarding unpaid invoices should be directed to the COR.

7.2.5. At a minimum, each invoice must contain the following: Dates of service, number of slides processed, unit price, and total cost of services provided, contract number, and remittance address. All invoices must include the name, title and phone number of person to be notified in the event of defective invoicing. Refer to FSC policy in completing and submitting Form OB-10 e-Invoice.

7.2.6. All invoices must be submitted for actual services performed by the Contractor. Invoices shall be submitted in accordance with, and at the prices specified in the continuation of SF Form 1449, Schedule of Supplies and Services of this agreement.

7.2.7. Invoice requirements and supporting documentation: Supporting documentation and invoices must be submitted no later than the 20th workday of the month. Subsequent changes or corrections shall be submitted by separate invoice. In addition to information required for submission of a “proper” invoice in accordance with FAR 52.212-4 (g), all invoices must include all information necessary using electronic means in accordance with the policy set forth by the VA Financial Services Center, Austin Texas, see previous paragraph.

7.3. SUBCONTRACTING:

If during the course of the Contract, the Contractor elects to subcontract to a different laboratory for the purpose of performing the services required under this Contract, the Contractor shall provide advance written notification to the COR. VANCHCS shall have the right to approve or disapprove the use of any proposed subcontractor based on a determination of the subcontractor’s ability to perform the services in accordance with VA’s standards for quality and consistency. In addition, prior to such approval the COR may require the Contractor to submit a sample of slides processed by the laboratory where services are to be performed.

EVALUATION CRITERIA

The Government will award a contract resulting from this solicitation to the responsible offeror whose offer, conforming to the solicitation, will be most advantageous to the Government, price and other factors considered. The following information or factors shall be used to evaluate offers. Award will not be made strictly on price but rather will consider the ability of the Contractor to produce high quality and consistent tissue blocks and slides that are considered visually acceptable by VA Pathology staff.

I. Technical/Quality

• Capability to perform – Offeror’s quote must demonstrate that it currently possesses appropriate certifications and accreditation and that it employs the personnel, equipment, standards, work processes, and general resources to accomplish the requirements of the PWS. Offeror must provide accompanying documentation of current license from a U.S. State, Commonwealth, Territory, or District, current CLIA certification and CAP accreditation, as well as any other accreditation or licensure that demonstrates its ability to provide the services.

• Professional qualifications and experience – Offeror must present qualifications and experience of the firm and histology supervisors and staff that will be performing the duties as required in the

PWS. Offeror shall provide accompanying documentation of current ASCP licensure for supervisory staff members. Offeror should also include documentation of ASCP licenses held by any staff members that will perform work under the contract.

• Similar clinical experience – Contractors with clinical experience most similar to the requirements of the PWS are greatly desired. Offerors shall present documentation of such experience. Offerors will also be required to provide a sample of H&E stained slides using their current processing/staining methods across a wide range of tissue types to ensure visual acceptability of the product. The sample presented to VA shall come from the Contractor’s laboratory where services will actually be performed.

• QA/QC Plan – Offeror shall provide a detailed plan which demonstrates how standards for quality will be met as per the requirements of the PWS.

III. Timeliness

• Offeror shall identify the place of performance (Contractor’s laboratory). Offeror shall also provide a detailed description which demonstrates how it will meet the required timeframes stated in the PWS, including a description of the transport methods to be utilized.

IV. Price

• Price per slide – Contractor must provide an all-inclusive price per slide processed.

II. Past Performance

• Clear performance history – Offeror’s performance history must show that it consistently operates in an effective and ethical manner without evidence of corporate malfeasance, employee malpractice, or activities which are counter to the standards and mission of the Department of

Veterans Affairs. Documentation should include a summary of contracts performed for other government and non-government entities. Contractor shall identify any contracts that were terminated for cause.

RECORDS MANAGEMENT OBLIGATIONS

A. Applicability

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

B. Definitions

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

The term Federal record:

1. includes VHA records.

2. does not include personal materials.

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

4. may include deliverables and documentation associated with deliverables.

C. Requirements

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

National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR

Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of

44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, the 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. VHA 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 VHA or destroyed except 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, the Contractor must report to VHA. 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 VHA 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 VHA 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 VHA policy.

8. The Contractor shall not create or maintain any records containing any non-public VHA information that is 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 VHA 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 VHA 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. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]

D. Flow down of requirements to subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms, and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the

Contractor.