Attachment B.docx

STATEMENT OF WORK (SOW)

Background The VA Long Beach Healthcare System (VALBHCS) providers preferred the VA Long Beach Pathology & Laboratory Medicine Service (PALMS) to use Prolaris to test for patient with cancer diagnostics. Prolaris is a molecular diagnostic test that measures the expression level of genes involved with tumor proliferation to predict disease outcome. Prolaris can be used in conjunction with other clinical parameters to determine prostate cancer aggressiveness.

Scope The contractor shall perform services for the VALBHCS PALMS. The contracted reference laboratory (Contractor) shall process the slides and/or perform analytical testing as defined by the Contractor's reference test manual, report analytical test results, and provide consultation services as required. All terms, conditions and requirements defined herein shall apply to any laboratory (i.e., branch, division, sub-contractor, etc.) performing reference testing on behalf of the Contractor.

The Prolaris® test combines existing clinicopathologic features (Gleason, PSA, Stage, % Positive, age) with a quantitative PCR analysis to measure the mRNA expression levels of 31 cell cycle progression genes and 15 control genes to measure tumor aggressiveness independent of but in addition to pathologic characteristics at the fixed time of biopsy.

The VALBHCS is located at:

VA Long Beach Healthcare System (VALBHS) Pathology & Laboratory Medicine Service 5901 E. 7th Street Long Beach, CA 90822

Period of Performance: one (1) Year base period with two (2) optional one (1) year.

Estimated Annual testing quantity order on an as need basis: 96

Specific Test Requirements qRT-PCR technology “Gold Standard” Assay TaqMan Cared using Applied Biosystems 7900HT Fast Real-Time 46 Gene RNA-expression test (31 CCP Gene Expression measured against 15 normal genes) Sample Requirements Sample: Prostate Needle Biopsy Selection of tissue sample:

a. The core with the greatest length of continuous tumor should be chosen.

b. Require ≥0.5 mm tumor length with ≥70% tumor density.

c. Can be from formalin fixed tissue blocks or 6 formalin fixed unstained consecutive sections on uncharged slides plus one H&E slide.

d. If the block cannot be sent, Myriad requires one slide for an H&E cut at 4 - 5 microns, plus, a minimum of 20 microns of unstained tissue, cut consecutively.

Deliverables Shipping: Contractor shall provide prefilled FedEx Priority label affixed to Packaging required for sample transportation upon request.

Turnaround Time: Patient results must be provided within 14 days of station sending out patient samples.

Delivery of clinical grade patient reports and data return to the VA in structured formats via secure file transfer mechanisms.

· Patient Facing Visual Diagram with QR Code for interactive report tutorial

· Provider Facing Risk stratification diagrams included comparison to NCCN groups and validated treatment thresholds.

· Provider QR code for interpretation of clinical diagrams and details included

· Disease Specific Mortality when untreated and Risk of Metastasis when treated calculation from Prolaris Cell-cycle Risk score CCR algorithm

· Separation of clinical and pathologic indications from Prolaris Cell Cycle Proliferation score CCP

· Additional Options: Faxed, Mailed, Sent to Secure Portal and other custom options based on preference in any data type.

Licensures Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation shall be considered. The Contractor shall be licensed/accredited by the College of American Pathologists (CAP), the Nuclear Regulatory Commission, Center for Disease Control, Medicare, and other state regulatory agencies as mandated by Federal and State statutes. In addition, the laboratory shall be certified as meeting the requirements of the Clinical Laboratory Improvement Act (CLIA) of 1988 and shall comply with the National Standards to Protect the Privacy of Personal Health Information in accordance with Health Insurance Portability and Accountability Account of 1996 (HIPAA).

Contractor copies of all relevant permits/licenses and certification inclusive of any sanctions current or pending throughout the United States of America are located at the link provided below. In addition, as these documents are reissued or reworded, the awarded Contractor shall supply a copy to the Contracting Officer. This documentation shall also be supplied for each reference laboratory that is a subcontractor of the primary Contractor.

The Contractor shall ensure that each facility is in compliance with the College of American Pathologists (CAP) standards, Clinical Laboratory Improvement Amendments (CLIA) standards, and VHA Directive 1106 and VHA Handbook 1106.01.

Additional Requirement Specifications

1. Performance Monitoring The Contractor shall furnish a monthly exception report and turn-around-times will be monitored as part of VA quality assurance plan.

The Myriad Genetics Laboratory Quality Manual MGL QA 3000 or equivalent is available at any time upon request.

2. Security Requirements The Contractor shall be responsible for the security and integrity of specimens and for compliance with all Health Insurance Portability and Accountability Act (HIPAA) requirements. The Contractor shall also be responsible for ensuring the proper credentialing of its employees who interact with personnel.

Additionally, the Contractor shall adhere to all Information Technology Security requirements as set forth in VA Handbook 6500.6 and shall adhere to Appendix C and Appendix D and submit proper documentation as required.

The reference laboratory shall assume full liability for the samples and data at the time of receipt. The Contractor shall use reasonable and appropriate safeguards to prevent use or disclosure of protected health information (PHI) not provided for by this solicitation.

Within 24 hours of the Contractor becoming aware of a HIPAA violation involving electronic transactions, paper labels and code sets, privacy, security or standard identifier, or disclosure of PHI not provided for by this solicitation, the Contractor shall report violations to the proper authorities identified in VA Handbook 6500.6.

The C&A requirements do not apply and that a Security Accreditation Package is not required. The contractors HIPAA Privacy and Security Policy is available at any time upon request.

3. Third Party contract terms and provisions The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. All VA policies shall be followed, and the contractor shall not copy, expose, and share information of Protected Health Information documents.

4. Hours of Operation

· Normal tour-of-duty hours at VA Healthcare Centers is 7:30 am to 5:00 pm, Monday through Friday, excluding Federal holidays. However, the service is operating 24/7 and as such there may be instances in which the vendor’s workday may be outside of this period. The vendor is required to coordinate these times with the designated Program Manager.

· In accordance with 5 U.S.C. 6103, Executive Order 11582 and Public Law 94-97 the following national holidays are observed and for the purpose of this contract are defined as “Legal Federal official holidays”

· When a holiday falls on a Sunday, the following Monday will be observed as a National Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National Holiday by U.S. Government Agencies.

5. Invoicing. The Contractor shall submit a monthly invoice for services rendered no later than 21 days following the close of the month in which the test result was reported. The invoice shall be checked for accuracy and shall display chronologically by date of Contractor receipt the name of the patient, the date of specimen collection by the Contractor, details of the test performed on each patient, and the unit and total testing costs. The Contractor shall not charge for repetitive testing performed on a specimen to verify questionable initial results.

Use obligation number for payment processing.

All invoices must be submitted via Tungsten at:

https://portal.tungsten-network.com/Login.aspx?ReturnUrl=%2f