PWS Genomic Health.docx

VANCHCS

Performance Work Statement Genomic Health Inc.

VA Northern California Health Care System will periodically send specimens for Oncotype DX testing which is a cancer assay used to predict whether certain patients will benefit from chemotherapy. Oncotype DX is the only multigene cancer assay incorporated into three major clinical guidelines as an option for this purpose.

Utilizing RT-PCR, Oncotype Dx for Breast measures the expression of 21 genes to provide clinicians with information on risk of cancer recurrence as well as likelihood of chemotherapy benefit versus whether hormone therapy alone will be effective. This test is used for early stage invasive breast cancer and provides results that are individualized for the patient. It is the most comprehensive test compared to others on the market and is utilized by the greatest number of Oncologic guidelines for patient care world-wide. It is the only test that provides information on chemotherapy benefit.

The Oncotype DX for Colon is the only genomic test with Level 1 evidence that provides a recurrence risk assessment that helps clinicians choose an individualized post-surgery therapy approach. It looks at 12 genes in each individual tumor. There are no other tests on the market for this.

Oncotype DX Breast DCIS Score test enables women and their doctors to personalize their treatment decisions and potentially forgo unnecessary treatment, such as radiation, when they have a low score and a low risk of local recurrence. For those with higher scores, the result confirms that they would indeed benefit from a more aggressive local approach to treatment, such as radiation therapy.

Oncoytpe DX- Breast

Oncoytpe DX- Colon

Oncoytpe DX- Breast DCIS

1. SCOPE OF WORK

1. 1 Contractor shall provide laboratory services preanalytic processing as defined in its laboratory user’s manual; analysis, reporting of analytic results, and consultation regarding selection, collection, transportation and result interpretation.

The contractor shall provide the following services:

1.1.2. Provide all necessary supplies, not limited to the following:

Specimen carriers All forms

1.1.3 Contractor shall supply any special preservatives required for specimen preservation.

1.1.4 Analyze samples.

1.1.5 Routine test results shall be reported within 24 hours of specimen testing. STAT test results shall be reported within 2 hours or less of specimen testing. Critical Value test results shall be reported immediately.

1.1.6 Consult with Laboratory on test results by telephone as needed.

1.1.7 Provide VAMC Laboratories with a means of communication to permit immediate inquiry regarding the status of pending tests.

1.1.8 Billing and test report summaries shall begin the first day of the month and include the last day of the month.

2. LICENSING AND ACCREDITATION.

2.1. Contractor shall have all licenses, permits, accreditation and certificates required by law.

2.1.2. Contractor shall be accredited by Centers for Prevention and Disease Control (CDC) under CLIA if contractor is engaged in interstate commerce.

2.1.3 Laboratory Director shall be a licensed American Board of Pathology certified pathologist or appropriately certified bio-analyst.

3. REPORTING OF RESULTS. A report is defined as a printed final copy in duplicate of laboratory testing results. This report shall be received by remote terminal where applicable. If results are telephoned, the report must include the name of the individual notified of the results. Each test report shall at minimum indicate the following information:

- Facility Name

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

-Unsatisfactory specimen shall be reported with regard to its unsuitability for testing.

4. CONTRACTOR PERSONNEL.

4.1 The Contractor shall make sure employees have current and valid professional certifications before starting work under this contract. Technologists, medical technicians, and cytotechnologist shall meet personnel qualifications required by Clinical Laboratory Improvement Act (CLIA) '88 Guidelines. Pathologists must have graduated from an approved school of medicine or osteopathy and completed a residency or fellowship in pathology acceptable to the United States Surgeons General must possess a valid license to practice clinical reference laboratory services from a United States (U.S.) jurisdiction; and shall have provided pathology services a minimum of 24 months within the past 36 months and pathology consultation services a minimum of 36 months within the past 48 months.

4.2 The Contractor shall maintain current licenses and certificates and provide copies of such to VA upon reasonable written request.

5. RECORDS

5.1 The Contractor shall be responsible for creating, maintaining and disposing of only those government required records that are specifically cited in the work statement or required by the provisions of a mandatory directive listed in section (d) Applicable Publications and Forms. If requested by the VA COR, the Contractor shall provide the original record, or a reproducible copy of any such record, promptly of receipt of the written request.

6. PATIENT LISTS

6.1 The Contractor shall treat patient lists, no matter how developed, as privileged information. Lists and/or names of patients shall not be disclosed to or revealed in any way for any use outside the participating VAMC without prior written permission by the VA COR or Chief of the Medical Staff.

7. RELEASE OF MEDICAL INFORMATION.

7.1 The Contractor shall not release any medical information obtained during the course of this contract to anyone outside the VA, unless authorized in writing by the VA COR and the patient, as required by applicable law.

8. PROFESSIONAL LIABILITY INSURANCE.

8.1 Professional liability insurance shall be 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.

9. BILLING/INVOICES:

9.1. 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.

9.2. 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.

9.3 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.

9.4 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.

9.5 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.

9.6 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.

9.7. 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.

10. SAFETY.

10.1 The Contractor shall comply with all applicable OSHA, Federal, State, laws, and regulations as required for performing the type of services required.

10.2 The C&A requirements do not apply, and that a Security Accreditation Package is not required.

Records Management Language for Contracts Required The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract:

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

4. 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 by the Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

10. 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, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.