SLC Prostate Test Reporting Final SOW.docx

Department of Veteran Affairs VA Medical Center, Salt Lake City, Utah Statement of Work Prostate Testing and Reporting

I. Introduction Department of Veterans Affairs, Veterans Health Administration, Salt Lake City VA Medical Center (VAMCSLC), 500 Foothill Drive, Salt Lake City, Utah 84148 has a requirement for reporting from prostate testing. The contract will be awarded as a Firm-Fixed Price, 5-Year Blanket Purchase Agreement with one year ordering periods.

II. Scope of Work The Contractor will provide Prostate Testing and Reporting. The prostate test and report are used to determine how likely the patient’s cancer is to metastasize within the next five years. The test is performed on tissue samples obtained during biopsy or surgical removal of the prostate.

III. Description A. The contractor shall be responsible for performing laboratory testing, analysis, and result interpretation on behalf of the VAMSLC facility in accordance with the terms, conditions, and provisions outlined thereof. The testing report will provide personalized treatment where the tumor analysis will identify patients at high versus low risk of progression of cancer.

B. The services performance shall include genomic testing with varying levels of support services depending on the unique characteristics presented by each individual ordering activity.

C. The contractor shall perform testing entirely upon their premises.

D. Tests will be performed and reported within established vendor turnaround times.

E. The contractor shall carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations as they pertain to a licensed clinical laboratory.

F. The contractor shall provide individual patient-chartable test result reports meeting Clinical Laboratory Improvement Amendments (CLIA) requirements.

G. The contractor shall provide all appropriate requisition forms and unique supplies needed for specialized collection of samples, at no additional charge.

H. Notwithstanding, anything to the contrary in this Agreement or otherwise,The contractor shall not release patient records that include test results, without the specific written consent to release such information as provided by the patient, to any person other than the ordering healthcare provider or designee. All patient records shall be treated as confidential so as to comply with all state and federal laws regarding the confidentiality of patient's records. This provision shall survive termination of this Agreement.

I. The required highly specific molecular testing reference laboratory services include but are not limited to the identified required test menu testing, specimen preparation and storage of clinical laboratory specimens, performance of analytical testing; reporting of analytical test results; and consultative services.

IV. Salient Characteristics (Technical Specifications) A. Dynamic Report A report must be generated with Patient Information, Specimen Information, Ordering Physician, Clinical and Pathology Details, Genomic Score, Genomic Score Interpretation, Risk Graph, Risk Estimates, Risk Graph Interpretation, Clinical Findings, Test Description, Intended Use, Confidence Interval, and References.

B. Genomic Score A Genomic Score must be generated based off of the genomic risk of metastasis, tumor biology alone, independent of clinical & pathological factors (e.g., Gleason, PSA), the 22 genes, 7 biological pathways, and continuous genomic risk score classified as low, intermediate or high.

C. Genomic Score Interpretation Provide a summary based on this patient’s genomic risk & relevant clinical findings.

D. Risk Estimates Provide the risk estimates of the patient with standard therapy.

E. Risk Graph Provide a Graph to show the patient their risk compared to patients with similar clinical and pathological features.

F. Risk Comparison Provide a comparison of the patient and their risk compared to patients with similar clinical and pathological features.

G. Risk Graph Interpretation Explains risk comparison graphic.

Provides this patient’s percentile rank in the tested population.

H. Clinical Findings Provide clinical study results relevant to this patient.

I. Test Description Provide a summary of testing platform technology.

Risk estimates.

Provide cut points separating low, intermediate & high risk.

J. Intended Use Provide a summary of the intended use in biopsy specimens from patients.

K. Confidence Interval Confidence Intervals Provide a confidence interval for each risk estimate.

F. References Provide references for each of the clinical studies cited in the report.

V. Schedule of Services Every test must include

· Patient Information

· Specimen Information

· Ordering Physician,

· Clinical and Pathology Details

· Genomic Score

· Genomic Score Interpretation

· Risk Graph, Risk Estimates

· Risk Graph Interpretation

· Clinical Findings

· Test Description

· Intended Use

· Confidence Interval

· References.

VI. General Requirements The contractor’s standard price list of all testing services available along with the price to be billed to the VHA for each testing service shall reflect that which is listed in their GSA price list.

The price list, at a minimum, shall include the following data elements:

· CPT code

· Product Name/Description

· Price

· Test description, including reference ranges and units of measurement

· Maximum turn-around-time (TAT) shall not exceed three weeks from specimen submission.

VII. Test Result Reporting

A. The Contractor shall provide encrypted and/or secured electronic transmission (i.e., fax and/or on-line web access) of all completed and/or partial test results to the ordering activity within published turnaround time of fifteen days.

B. All payments shall be made in arrears (30 days) upon receipt of a proper invoice. Invoices must contain at a minimum the following information. The contractor shall provide this information on one original invoice:

i. Invoice Number

ii. Date of Service

iii. Test Description and CPT Code

iv. Unit cost

v. Total cost

VIII. Mandatory Requirements

A. Licensing and Accreditation: Only fully licensed and accredited laboratories actively engaged in providing the specific services and laboratory testing outlined. The contractor shall have all the licenses, permits, accreditation and certificates required by law. The reference laboratory must be licensed and accredited by the College of American Pathologists (CAP) 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 Department of Health and Human Services Clinical Laboratory Improvement Amendments of 1988.

B. The contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America prior to contract award. In addition, the contractor shall be responsible for providing a written guarantee or evidence that all subcontractors have appropriate licensure and accreditation to perform tests that the primary contractor cannot perform prior to contract award. Any proposed subcontractor changes during the contract performance period must have prior approval by the Local VA Point of Contact (POC).

C. The Contractor policies and procedures shall comply with the Health Insurance Portability and Accountability Act (HIPAA).

D. The contractor will provide and maintain quality assurance programs which meet federal regulations for laboratory operations. The contractor will be certified by the College of American Pathologist under the CLIA.

E. The contractor shall notify the POC in writing of any malpractice investigation or licensure or certification suspension which concerns the contractor or any employees, within 24 hours of notification of an investigation or suspension.

F. Contractor Personnel: The contractor shall maintain current accreditation and notify the POC of any lapse in state license, CLIA certification, or clinical pathology certification.

G. The contractor shall provide a copy of renewed licenses/certificates to the POC before expiration.

IX. Contractors Responsibilities A. Procedure Guidance:

i. The testing methodology and reference ranges for a test must be defined and available electronically. The contractor shall provide change notice prior to implementation of any new medical procedures and services.

ii. The contractor shall ensure that all procedures performed are of current acceptable standard deviation with at least (minimum) daily controls conducted to determine procedure accuracy. Upon request by the Laboratory Point of Contact (POC), the contractor will make available quality assurance information on specific testing procedures for review.

iii. In the event of tests being referred to another laboratory, there shall be no additional transfer charge or confirmation charge to the government.

X. Reporting of Results:

A testing report is defined as a printed final copy of laboratory testing results. The report(s) shall be available on an encrypted and/or secured electronically with on-line web access and /or secured facsimile (Fax).

Each test report shall at minimum indicate the following information:

XI. Retention of Specimens:

Upon completion of the testing procedures, the contractor shall retain all specimens as required by regulatory agencies. Upon request by the ordering activity POC or designee, the contractor shall provide a copy of the regulatory requirements for each participating regulatory agency. In the absence of regulatory agency requirements, the contractor shall retain specimens, after all testing has been completed for clinical specimens (7) days.

XIII. Special Contract Requirements

A. The services specified herein may be changed by written modification to the BPA. The VA POC will prepare the modification and, prior to becoming effective, must be signed by both parties.

B. Only the POC is authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this agreement. In the event the contractor affects any such change at the direction of any person other than the POC, the change shall be considered unauthorized, and no adjustment will be made to the contract price to cover any increase in costs incurred as a result thereof.

C. This is a non-personal services contract as defined in FAR 37.101. There is no employer-employee relationship between the Government and the contractor or the contractor’s employee(s). Contractor personnel are not subject to the supervision and control of a government officer or employee. Rather, contractor personnel perform their duties in accordance with the Performance Work Statement. Supervisory functions such as hiring, firing, directing, and counseling of contractor personnel are not performed by the Government. The healthcare provider who furnishes services under this contract is subject to Government technical oversight of the services. The Government retains the right to reject services for contractual non-performance.

D. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered.

E. Contractor shall, in writing, keep the POC informed of any unusual circumstances in conjunction with the contract.

F. Contractor shall not, under any circumstances, furnish reports directly to patients.

XIV. Term of the Contract

The contract will be awarded as a Firm-Fixed Price, 5-Year Blanket Purchase Agreement with one year ordering periods.

XV. Federal Holidays

A. The contractor is not required to provide these laboratory services on federal holidays. The 10 holidays observed by the Federal Government are:

New Year’s Day (January 1st) Martin Luther King’s Birthday (3rd Monday in January) Presidents’ Day (3rd Monday in February) Memorial Day (last Monday in May) Independence Day (July 4th) Labor Day (1st Monday in September) Columbus Day (2nd Monday in October) Veterans Day (November 11) Thanksgiving Day (4th Thursday in November) Christmas Day (December 25th) Any other day specifically declared by the President of the United States to be a national holiday.

B. When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by U.S. Government agencies.

XVI. Qualifications/Requirements of Laboratory & Contractor Personnel

A. The contractor to including subcontractor(s), must continuously hold a Certificate of Compliance or Certificate of Accreditation from the Centers for Medicare & Medicaid Services as meeting the requirements of the CLIA of 1988, or must demonstrate accreditation by a regulatory agency(s) with deemed status from the College of American Pathologists, and/or other state regulatory agencies, as appropriate, and as mandated by federal and state statutes. The reference laboratory must maintain valid certifications during the entire performance period of this contract.

B. Copies of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America must be supplied in response to this procurement action. In addition, as these documents are re-issued or re-awarded, the awarded contractor must supply a copy to the POC assigned to the servicing Government facility. The above documents must also be supplied for each reference laboratory that is a subcontractor of the primary contractor.

C. The contractor must notify immediately the POC in writing, upon its loss of any required certification, accreditation, or licensure.

D. The contractor shall maintain safety and health standards consistent with the requirements set forth by the Occupational, Health and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention.

XVII VA Handbook 6500.6

APPENDIX C

1. GENERAL. This entire section applies to all acquisitions requiring any Information Security and Privacy language. Contractors, contractor personnel, subcontractors and subcontractor personnel will be subject to the same federal laws, regulations, standards, VA directives and handbooks, as VA personnel regarding information and information system security and privacy.

2. VA INFORMATION CUSTODIAL LANGUAGE. This entire section applies to all acquisitions requiring any Information Security and Privacy language.

a. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter “contract”) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is FAR 52.227-19, Commercial Computer Software License.

b. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General.

c. VA information will not be co-mingled with any other data on the contractor’s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization.

d. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with Federal and VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector General (OIG), and/or Government Accountability Office (GAO) staff during periodic control assessments, audits, or investigations.

e. The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies.

f. The contractor shall not make copies of VA information except as specifically authorized and necessary to perform the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed in accordance with VA Directive 6500, VA Cybersecurity Program and VA Information Security Knowledge Service.

g. If a Veterans Health Administration (VHA) contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken in accordance with VHA Directive 1605.05, Business Associate Agreements. If there is an executed national BAA associated with the contract, VA will determine what actions are appropriate and notify the contactor.

h. The contractor shall store and transmit VA sensitive information in an encrypted form, using VA-approved encryption tools which are, at a minimum, Federal Information Processing Standards (FIPS) 140-2, Security Requirements for Cryptographic Modules (or its successor) validated and in conformance with VA Information Security Knowledge Service requirements. The contractor shall transmit VA sensitive information using VA approved Transport Layer Security (TLS) configured with FIPS based cipher suites in conformance with National Institute of Standards and Technology (NIST) 800-52, Guidelines for the Selection, Configuration and Use of Transport Layer Security (TLS) Implementations.

i. The contractor’s firewall and web services security controls, as applicable, shall meet or exceed VA’s minimum requirements.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two situations: (i) in response to a qualifying order of a court of competent jurisdiction after notification to VA CO (ii) with written approval from the VA CO. The contractor shall refer all requests for, demands for production of or inquiries about, VA information and information systems to the VA CO for response.

k. Notwithstanding the provision above, the contractor 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 medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection with Human Immunodeficiency Virus (HIV). If the contractor is in receipt of a court order or other requests for the abovementioned information, the contractor shall immediately refer such court order or other requests to the VA CO for response.

l. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract will be protected and secured in accordance with VA Directive 6500 and Identity and Access Management (IAM) Security processes specified in the VA Information Security Knowledge Service.

m. Any data destruction done on behalf of VA by a contractor shall be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management, VA Handbook 6300.1, Records Management Procedures, and applicable VA Records Control Schedules.

n. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Directive 6500 and NIST 800-88, Guidelines for Media Sanitization prior to termination or completion of this contract. If directed by the COR/CO, the contractor shall return all Federal Records to VA for disposition.

o. Any media, such as paper, magnetic tape, magnetic disks, solid state devices or optical discs that is used to store, process, or access VA information that cannot be destroyed shall be returned to VA. The contractor shall hold the appropriate material until otherwise directed by the Contracting Officer’s Representative (COR) or CO. Items shall be returned securely via VA-approved methods. VA sensitive information must be transmitted utilizing VA-approved encryption tools which are validated under FIPS 140-2 (or its successor) and NIST 800-52. If mailed, the contractor shall send via a trackable method (USPS, UPS, FedEx, etc.) and immediately provide the COR/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the COR/CO within 30 business days of termination of the contract.

p. All electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) used to store, process or access VA information will not be returned to the contractor at the end of lease, loan, or trade-in. Exceptions to this paragraph will only be granted with the written approval of the VA Contracting Officer.

3. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS. This section applies when any person requires access to information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract.

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees and subcontractors only to the extent necessary to perform the services specified in the solicitation or contract. This includes indirect entities, both affiliate of contractor/subcontractor and agent of contractor/subcontractor.

b. Contractors and subcontractors shall sign the VA Information Security Rule of Behavior (ROB) before access is provided to VA information and information systems (see Section 4, Training, below). The ROB contains the minimum user compliance requirements and does not supersede any policies of VA facilities or other agency components which provide higher levels of protection to VA’s information or information systems. Users who require privileged access shall complete the VA elevated privilege access request processes before privileged access is granted.

c. All contractors and subcontractors working with VA information are subject to the same security investigative and clearance 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 shall be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office of Human Resources and Administration/Operations, Security and Preparedness (HRA/OSP) is responsible for these policies and procedures. Contract personnel who require access to classified information or information systems shall have an appropriate security clearance. Verification of a Security Clearance shall be processed through the Special Security Officer located in HRA/OSP. Contractors shall conform to all requirements stated in the National Industrial Security Program Operating Manual (NISPOM).

d. All contractors and subcontractors shall comply with conditions specified in VAAR 852.204-71(d); Contractor operations required to be in United States. All contractors and subcontractors working with VA information must be permanently located within a jurisdiction subject to the law of the United States or its Territories to the maximum extent feasible. If services are proposed to be performed abroad the contractor must state where all non-U.S. services are provided. The contractor shall deliver to VA a detailed plan specifically addressing communications, personnel control, data protection and potential legal issues. The plan shall be approved by the COR/CO in writing prior to access being granted.

e. The contractor shall notify the COR/CO in writing immediately (no later than 24 hours) after personnel separation or occurrence of other causes. Causes may include the following:

(1) Contractor/subcontractor personnel no longer has a need for access to VA information or VA information systems.

(2) Contractor/subcontractor personnel are terminated, suspended, or otherwise has their work on a VA project discontinued for any reason.

(3) Contractor believes their own personnel or subcontractor personnel may pose a threat to their company’s working environment or to any company-owned property. This includes contractor-owned assets, buildings, confidential data, customers, employees, networks, systems, trade secrets and/or VA data.

(4) Any previously undisclosed changes to contractor/subcontractor background history are brought to light, including but not limited to changes to background investigation or employee record.

(5) Contractor/subcontractor personnel have their authorization to work in the United States revoked.

(6) Agreement by which contractor provides products and services to VA has either been fulfilled or terminated, such that VA can cut off electronic and/or physical access for contractor personnel.

f. In such cases of contract fulfillment, termination, or other causes; the contractor shall take the necessary measures to immediately revoke access to VA network, property, information, and information systems (logical and physical) by contractor/subcontractor personnel. These measures include (but are not limited to): removing and then securing Personal Identity Verification (PIV) badges and PIV – Interoperable (PIV-I) access badges, VA-issued photo badges, credentials for VA facilities and devices, VA-issued laptops, and authentication tokens. Contractors shall notify the appropriate VA COR/CO immediately to initiate access removal.

g. Contractors/subcontractors who no longer require VA access will return VA issued property to VA. This property includes (but is not limited to): documents, electronic equipment, keys, and parking passes. PIV and PIV-I access badges shall be returned to the nearest VA PIV Badge Issuance Office. Once they have had access to VA information, information systems, networks and VA property in their possessions removed, contractors shall notify the appropriate VA COR/CO.

4. TRAINING.

a. All contractors and subcontractors requiring access to VA information and VA information systems shall successfully complete the following before being granted access to VA information and its systems:

(1) VA Privacy and Information Security Awareness and Rules of Behavior course (Talent Management System (TMS) #10176) initially and annually thereafter.

(2) Sign and acknowledge (electronically through TMS #10176) understanding of and responsibilities for compliance with the Organizational Rules of Behavior, relating to access to VA information and information systems initially and annually thereafter; and

(3) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system or information access [to be defined by the VA program official and provided to the VA CO for inclusion in the solicitation document – i.e., any role-based information security training.

b. The contractor shall provide to the COR/CO a copy of the training certificates and certification of signing the Organizational Rules of Behavior for each applicable employee within five days of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training 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 required training is complete.

5. SECURITY INCIDENT INVESTIGATION

a. The contractor, subcontractor, their employees, or business associates shall immediately (within one hour) report suspected security / privacy incidents to the VA OIT’s Enterprise Service Desk (ESD) by calling (855) 673-4357 (TTY: 711). The ESD is OIT’s 24/7/365 single point of contact for IT-related issues. After reporting to the ESD, the contractor, subcontractor, their employees, or business associates shall, within one hour, provide the COR/CO the incident number received from the ESD.

b. To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved and the circumstances surrounding the incident, including the following:

(1) The date and time (or approximation of) the Security Incident occurred.

(2) The names of individuals involved (when applicable).

(3) The physical and logical (if applicable) location of the incident.

(4) Why the Security Incident took place (i.e., catalyst for the failure).

(5) The amount of data belonging to VA believed to have been compromised.

(6) The remediation measures the contractor is taking to ensure no future incidents of a similar nature.

c. After the contractor has provided the initial detailed incident summary to VA, they will continue to provide written updates on any new and relevant circumstances or facts they discover. The contractor, subcontractor, and their employes shall fully cooperate with VA or third-party entity performing an independent risk analysis on behalf of VA. Failure to cooperate may be deemed a material breach and grounds for contract termination.

d. VA IT contractors shall follow VA Handbook 6500, Risk Management Framework for VA Information Systems VA Information Security Program, and VA Information Security Knowledge Service guidance for implementing an Incident Response Plan or integrating with an existing VA implementation.

e. 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 the VA Office of 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.

f. The contractor shall comply with VA Handbook 6500.2, Management of Breaches Involving Sensitive Personal Information, which establishes the breach management policies and assigns responsibilities for the oversight, management and reporting procedures associated with managing of breaches.

g. With respect to unsecured Protected Health Information (PHI), the contractor is deemed to have discovered a data breach when the contractor knew or should have known of breach of such information. When a business associate is part of VHA contract, notification to the covered entity (VHA) shall be made in accordance with the executed BAA.

h. If the contractor or any of its agents fails to protect VA sensitive personal information or otherwise engages in conduct which results in a data breach involving any VA sensitive personal information the contractor/subcontractor processes or maintains under the contract; the contractor shall pay liquidated damages to the VA as set forth in clause 852.211-76, Liquidated Damages— Reimbursement for Data Breach Costs.

(End of Appendix C) (End of Statement of Work)

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