Draft PWS.pdf

Performance Work Statement

Veterans Affairs Northern California Health Care System (VANCHCS)

Pathology and Laboratory Medicine Services (P&LMS)

Oncotype DX Genomic Prostate Score (GPS) tes ng

1. SCOPE:

VANVHCS P&LMS located in Sacramento, CA requests a Vendor to perform services in gene expression assay and Oncotype DX tes ng for cancers of the prostate. This specialized tes ng is beyond our scope of services to provide in-house.

2. BACKGROUND:

The use of the Oncotype DX test is a recommenda on by the Na onal Comprehensive Cancer Network (NCCN). These tests aid in determining the next step to take in the treatment and prognosis of pa ents diagnosed with prostate cancer.

The Oncotype DX GPS prostate cancer tes ng applies advanced genomic science to reveal the unique biology of a pa ent’s tumor to op mize cancer treatment decisions. By providing answers to key ques ons about the aggressiveness of and appropriate treatment for early-stage cancer, the prac ce-changing tests help physicians and pa ents select the right treatment at the right me in each individual case. In this way, Oncotype DX GPS tes ng helps pa ents and their physicians to op mize their cancer care and outcomes, enabling many pa ents to avoid unnecessary procedures and therapies, and saving the healthcare system billions of dollars in unnecessary costs.

3. BILLING:

Vendor shall bill monthly in arrears and process the billing through the Government E-Invoice system. www.Tungsten-network.com

4. VENDOR RESPONSIBILITIES:

a. The vendor shall provide all personnel, equipment, tools, materials, supervision, other items, and non-personal services necessary to perform gene expression assay, Oncotype DX tes ng as defined in the Performance Work Statement. The Vendor shall perform to the standards in this contract.

b. The Vendor shall provide VANCHCS services for:

DRAFT

i. ConfirmMDx tes ng- Prostate (CPT code 81551)

ii. SelectMDx tes ng - Prostate (PLA code 0339U)

iii. Oncotype DX GPS tes ng -Prostate (PLA code 0047U)

c. The Vendor shall develop and maintain an effec ve quality control program to ensure services are performed in accordance with this PWS.

i. The Vendors quality control program is how they assure themself that their work complies with the requirement of this contract.

ii. The Vendor shall develop and implement procedures to iden fy, prevent and ensure non-recurrence of defec ve services.

d. The Vendor shall agree to par cipate in an on-going Quality Assurance surveillance plan.

i. The Vendor shall be evaluated by the Government under this contract in accordance with the Quality Assurance Surveillance Plan.

ii. This plan is primary focused on what the Government must do to ensure that the Vendor had performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

e. Vendor shall provide specimen transporta on kit boxes and all applicable forms necessary to perform the specific tes ng. VANCHCS shall provide the informa on as requested on the Oncotype DX Assay Requisi on Form.

f. The Vendor shall send the pa ents’ results to the lab department listed on the Requisi on Form via fax. The Vendor provides reports that summarize the findings of the pa ent’s test. A detailed Oncotype DX GPS assay report is generated for each pa ent, with assay results provided as a Recurrence Score result (0-100).

5. ACCREDITATION:

a. The Vendor shall provide all licenses, permits, and be able to meet accredita on and cer ficates required by law.

b. The laboratory must be accredited by the College of American Pathologist (CAP) or be able to meet the Joint Commission and Clinical Laboratory Improvement Amendments (CLIA) (Public law 100-578) cer fica ons.

c. The Contractor will provide current copies of these records at the me of contract award and annually on the anniversary date of contract award to the Contrac ng Officer’s Representa ve (COR) or upon request.

6. CONFENTIALLY/SECURITY:

a. The Contractor, Contractor employees, and Subcontractors shall be subject to the

Privacy Act of 1974 and HIPAA of 1996.

b. The contractor is not authorized to release any medical record informa on. VANCHCS is the sole en ty authorized to release this informa on upon wri en request submi ed via facsimile or mail from the pa ent.

c. The VANCHCS will provide the Contractor with access to per nent pa ent medical informa on, within the exis ng privacy rules and regula ons, for the purpose of providing coordinated comprehensive medical care.

d. Contractors shall ensure the confiden ality of all pa ent informa on and shall be held liable in the event of the breach of confiden ality.

e. The C and A requirements do not apply; a Security Accredita on Package is not required.

7. RECORDS MANAGEMENT OBLIGATIONS:

A. Applicability

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

B. Defini ons

“Federal record” as defined in 44 U.S.C. § 3301, includes all recorded informa on, regardless of form or characteris cs, made or received by a Federal agency under Federal law or in connec on with the transac on of public business and preserved or appropriate for preserva on by that agency or its legi mate successor as evidence of the organiza on, func ons, policies, decisions, procedures, opera ons, or other ac vi es of the United States Government or because of the informa onal 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 documenta on associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regula ons, as well as Na onal Archives and Records Administra on (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regula ons 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 preserva on of all records, regardless of form or characteris cs, mode of transmission, or state of comple on.

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 Informa on 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 disposi on only as permi ed by statute or regula on.

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 documenta on to permit understanding and use of the records and data.

4. VHA and its contractors are responsible for preven ng the aliena on or unauthorized destruc on of records, including all forms of mu la on. 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 wri en concurrence of the Head of the Contrac ng Ac vity.

Willful and unlawful destruc on, damage, or aliena on of Federal records is subject to the fines and penal es imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, altera on, or destruc on 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 no fy the appropriate Contrac ng Officer upon discovery of any inadvertent or unauthorized disclosures of informa on, data, documentary materials, records, or equipment. Disclosure of non-public informa on is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administra ve, technical, and physical safeguards are established to ensure the security and confiden ality of this informa on, data, documentary material, records, and/or equipment is properly protected. The Contractor shall not remove material from Government facili es or systems, or facili es or systems operated or maintained on the Government’s behalf, without the express wri en permission of the Head of the Contrac ng Ac vity. When informa on, data, documentary material, records, and/or equipment is no longer required, it shall be returned to VHA control or the Contractor must hold it un l otherwise directed. Items returned to the Government shall be hand-carried, mailed, emailed, or securely electronically transmi ed to the Contrac ng Officer or address prescribed in the [contract vehicle]. Destruc on of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contrac ng Officer's approval prior to engaging in any contractual rela onship (sub-contractor) in support of this contract requiring the disclosure of informa on, documentary material, and/or records generated under, or rela ng to, contracts.

The Contractor (and any sub-contractor) is required to abide by Government and VHA guidance for protec ng sensi ve, proprietary informa on, classified, and controlled unclassified informa on.

7. The Contractor shall only use Government IT equipment for purposes specifically ed 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 informa on that is not specifically ed to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains informa on covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemp on to the Freedom of Informa on 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 iden fied 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 ini al 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 wri en subcontractor acknowledgment of same.

2. Viola on by a subcontractor of any provision set forth in this clause will be a ributed to the Contractor.