SOW Karius Test.docx

Performance Work Statement Karius Next Generation Sequencing Test

I. Introduction

Texas Valley Coastal Bend Health Care System (TVCBHCS) of Pathology and Laboratory Medicine Services has a need to provide Karius Next Generation sequencing testing to improve timely diagnosis and treatment of patients with sepsis, pneumonia, endocarditis, especially in the immunocompromised patient population, in whom infections are notoriously difficult to diagnose. The Karius test has been shown to improve diagnostic yield compared to blood cultures and lead to faster time to diagnosis compared to conventional microbiologic tests.

Karius Next Generation Sequencing Test is a unique Laboratory Developed Test (LTD) which identifies and quantifies microbial cell-free DNA from plasma using metagenomic next generation sequencing technology. The test is unique because it is non-invasive and does not require a specimen from the site of infection. The Karius test is the only test of its kind currently on the market as a non-invasive approach for rapid, high yield diagnosis of over 1,000 clinically relevant pathogens, including bacteria, fungi, parasites, and DNA viruses. In a landmark validation study published in Nature Microbiology, Karius test was found to have >95% sensitivity and >99.99% specificity when compared to hundreds to clinical samples with known infectious status.

The Contractor shall provide Karius laboratory testing service to include specimen requirements, means of transport for specimens from VA laboratories to contractor’s laboratory, processing, and analysis of the specimen. Consultation regarding selection, collection, transportation, and result interpretation shall also be provided when required.

II. Contractor Responsibilities

(a) Provide all supplies necessary to transport the specimens to include:

(1) Lab test request forms

(4) Transportation envelopes or packs with tracking air bills

(b) A Laboratory User’s Manual or similar documentation will be provided to TVCBHCS Laboratory. The manual shall include the testing methodology used for each test, test reference ranges, and specimen requirements and any special handling required.

(c) Transport samples in such a manner as to ensure the integrity of the specimen. Contractor will supply any special preservatives required for specimen preservation. All specimens shall be shipped in containers provided by contractor.

(d) Analyze samples. The contractor shall return the test results to the TVCBHCS Laboratory within established timeframes.

(e) Contractor shall provide the VA laboratories with a means of communication to permit immediate inquiry regarding the status of pending tests.

(f) Contractor shall consult with VA Laboratories on test results by telephone when urgency of situation requires.

(g) The contractor must be licensed under CLIA (Clinical Laboratory Improvement Amendments). The VA Laboratories reserves the right to request the results of any proficiency testing that the contractor subscribes.

(h) Contractor shall provide monthly billing for tests provided by the 20th of each month following the month in which the service was delivered.

(i) IT Security: Certification and Accreditation requirements do not apply. A security Accreditation Package is not required.

III. Reporting of Test Results A report is defined as a final electronically secured copy of laboratory test results. Each test report shall at a minimum indicate the following information:

(a) Patient’s name and unique identifier. When available; the VA Integration Control Number (ICN) will be used in lieu of the unique patient specimen identifier.

ICN is the VA’s enterprise generated unique person identifier.

(b) Physician’s name (if supplied)

(c) Medical Center or VA facility name

(d) Patient’s location, e.g. clinic, ward (if supplied)

(e) Test ordered

(g) Date/time of specimen collection (when available)

(h) Date/time specimen received in Reference Lab

(i) Date test completed

(j) Test result

(k) Flag abnormal results

(l) Reference Range

(m) Toxic and/or therapeutic range where applicable

(n) Name of testing laboratory (contractor and/or subcontractor)

(o) Testing laboratory specimen number

(p) Type of specimen

(q) Comments related to the test provided by the submitting lab

(r) Information that may indicate a questionable validity of test results

(s) Unsatisfactory specimen shall be reported with reason as to its unsuitability for testing

**Test reports shall be available for retrieval from the secured Karius lab portal by designated authorized TXVCBHCS Laboratory personnel.

Period of Performance

A. Base Period: 04/01/2025-03/31/2026 B. Option Year One: 04/01/2026-03/31/2027 C. Option Year Two: 04/01/2027-03/31/2028 D. Option year Three: 04/01/2028-03/31/2029

IV. Quality Control Contractor shall notify the VA Laboratory Director (or designee) immediately by phone or email of any testing errors or defective tests. The notification shall be followed up by a written statement with recommended actions to take to remedy or resolve the situation. If the Contractor has defects or errors in their testing procedure that caused erroneous results, the Contractor shall repeat the test at no charge to the VA or provide a credit to the VA. The choice of which will be discussed between the VA and the Contractor.

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

V. Testing Changes The Contractor shall advise the TVCBHCS Laboratory Director (or designee) of any changes in assay methodology, procedures, reference ranges and any new tests introduced.

If the contractor changes the assay procedures or a critically important component of an assay (e.g., an antibody, purified antigen, etc.) the contractor shall notify the VA Laboratory Director (or designee) prior to the intended change. The contractor shall provide documentation that the quality and efficacy of the test will remain unchanged or be improved.

VI. VA Laboratory Responsibilities The VA Laboratories will provide laboratory specimens prepared in accordance with the contractor’s Laboratory User’s Manual. All specimens will be properly identified and labeled for testing.

The VA Laboratories will ship clinical specimens to the contractor on the same day of collection, excluding weekends and holidays. If a specimen is drawn on a weekend or holiday and can be preserved, it will be shipped on the next regular business day. All specimens will be properly stored in accordance with the policies and procedures of the reference lab.

VII. Changes to the Performance Work Statement

Any changes to this PWS shall be authorized and approved only through written correspondence from the CO and/or a modification of the contract. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

VIII. CONTRACTOR QUALIFICATIONS AND INFORMATION SECURITY REQUIREMENTS

1. The reference laboratory and any subcontractors thereof must be licensed or accredited by the College of American Pathologists and/or other state regulatory agencies as mandated by federal and state statutes. In addition, the laboratory must 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).

2. 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.

3. The contracted laboratory must meet HIPPA requirements. The contractor shall be required to be in compliance with the Health Insurance Portability and Accountability Act of 1996 regulations and when needed, will be required to sign a Business Associate Agreement with the VA. The signed agreement will be returned to the contracting officer and a signed copy will be returned to the contractor for their files.

4. The contractor shall ensure the confidentiality of all patient information being faxed, mailed or transported and will be held liable in the event of a breach of confidentiality. The contractor shall comply with the provision of the Federal Privacy Act of 1974 (Public Law 93-579), HIPAA (Public Law 104-191), and the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment and Rehabilitation Act of 1972 (Public Law 93-255), as well as any other statutes regarding confidentiality of patient information during and after the execution of the contract. The contractor shall obtain a signed confidentiality certificate from each employee that may have access to medical record information prior to allowing them to work on this contract. Any information about an individual that is maintained by the VA shall be kept confidential. A copy of a signed certificate shall be provided to the CO upon request.

5. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by the VA which has been generated by the contractor in performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response. Press releases, marketing material, or any other printed or electronic documentation related to this contract, shall not be publicized without the written approval of the CO.

6. Contractor Personnel Security Requirements: All contractor employees who require access to the Department of Veterans Affairs’ computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance. This requirement is applicable to all subcontractor personnel requiring the same access. If the investigation is not completed prior to the start date of the contract the contractor will be responsible for the actions of those individuals that provide or perform work for the VA.

A. Position Sensitivity – The position sensitivity has been designated as (low) risk.

B. Background Investigation – The level of background investigation commensurate with the required level of access is National Agency Check (NACI) with written inquiries.

C. Contractor Responsibilities

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

The web site which provides information on the cost of the security investigation is: www.opm.gov\extra\investigate – Select Federal Investigations Notices (FIN 01-01)

b. The contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship and are able to read, write, speak, and understand the English language.

c. The contractor will provide to the Contracting Officer prior to award the following: (1) List of names of contract personnel. (2) Social security numbers of contractor personnel. (3) Home address of contractor personnel or the contractor address.

The Contracting Officer will submit the above information to the Office of Security and Law Enforcement, Washington, D.C. The Office of Security and Law Enforcement will provide the necessary investigative forms (these forms are indicated in paragraph 3.d. below) to the contractor’s personnel, coordinate the background investigations with OPM and notify the Contracting Officer and contractor of the results of the investigation.

d. The contractor shall submit or have their employees submit the following required forms to the VA Office of Security and Law Enforcement within 30 days of receipt:

(i) Standard From 85P, Questionnaire for Public Trust Positions

(ii) Standard Form 85P-S, Supplemental Questionnaire for Selected positions

(iii) FD 258, U.S. Department of Justice Fingerprint Applicant Chart

(iv) VA Form 0710, Authority for Release of Information Form

(v) Optional Form 306, Declaration for Federal Employment

(vi) Optional Form 612, Optional Application for Federal Employment

d. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract.

e. Failure to comply with the contractor personnel security requirements may result in termination of the contract for default.

IX. SECURITY CONTROLS COMPLIANCE TESTING

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days’ notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

X. TRAINING

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete VA Privacy and Information Security Awareness and Rules of Behavior Training and Privacy and HIPAA Training and HIPAA Training 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 Rules of Behavior before being granted access to VA information and its systems.

b. The contractor shall provide to the contracting officer and/or the Program Manager (PM) a copy of the training certificates and certification of signing the Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c. 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.

The Certification and Accreditation (C&A) requirements do not apply and a Security Accreditation Package is not required for this SOW.

XI. VA INFORMATION CUSTODIAL LANGUAGE

A. 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).

B. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

C. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing 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.

D. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

E. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or 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.

F. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

G. If a VHA contract is terminated for cause, the associated BAA must also be terminated, and appropriate actions taken in accordance with VHA Handbook 1600.1, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

H. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

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

J. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

K. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

L. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the PM.

XII. SECURITY INCIDENT INVESTIGATION:

A. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the PM and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

B. To the extent known by the contractor/subcontractor, the 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.

C. 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.

D. 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.

XIII. LIQUIDATED DAMAGES FOR DATA BREACH:

A. 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. However, it is the policy of the VA to forego collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.

B. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity 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.

C. Each risk analysis shall address all relevant information concerning the data Beach, including the following:

(b)data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

D. 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 for affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

Information Systems Officer, Information Protection:

The contractor will not have access to VA Desktop computers and will not have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

Privacy Officer

The contractor will have access to protected Patient Health Information (PHI) and will have the capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for Contractor analyses is de-identified.

Records Management

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. TVCBHCS 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 TVCBHCS 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 TVCBHCS. 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 TVCBHCS 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 TVCBHCS 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 TVCBHCS policy.

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