Description
PERFORMANCE WORK STATEMENT Trans#501-17-1-036-0003 PART 1 GENE EXPRESSION ASSAY ONCOTYPE DX GENERAL INFORMATION 1.1.0 Description of Services/Introduction: The contractor shall provide all personnel, equipment, tools, materials, supervision, and other items and non-personal services necessary to perform gene expression assay, Oncotype DX testing as defined in this Performance Work Statement. The contractor shall perform to the standards in this contract. 1.2.0 Background: The use of the Oncotype DX test is a recommendation by the National Comprehensive Cancer Network (NCCN) that is followed by VISN 18 Hematologists and Oncologists. This test aids in determining the next step to take in the treatment and prognosis of patients diagnosed with early stage I or stage II, node negative, estrogen receptor-positive invasive breast cancer. 1.3.0 Objectives: Provide Breast Oncotype DX testing services (CPT 81519) Provide Colon Oncotype DX testing services (CPT 81525) Provide Prostate Oncotype DX testing services (CPT 81479) Provide DX Oncotype testing services (CPT 88342) 1.4.0 Scope: The contractor shall provide the Oncotype DX breast cancer, colon, prostate and Oncotype DX assay. This test examines a breast cancer patient's tumor tissue at a molecular level, and gives information about a patient's individual disease. This information can help individualize breast cancer treatment planning and identify options. The level of activity of a gene or group of genes test commercially available that has clinical evidence validating its ability to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer. The Oncotype DX gene expression assay is intended to be used by women with early-stage (stage I or II), node-negative, estrogen receptor-positive (ER+) invasive breast cancer who will be treated with hormone therapy. The Oncotype DX colon cancer test is a multi-gene test for predicting recurrence risk in patient with stage II and stage III A/B colon cancer to enable an individualized approach to treatment planning. By evaluating specific genes within a patient's colon tumor, the test can determine the likelihood that the cancer cells will spread and cause the disease to recur, or return after surgery. The Oncotype DX prostate cancer test is a multi-gene test has been clinically validated to predict aggressive cancer at the time of diagnosis, helping to identify those men who need immediate surgery or radiation therapy versus those who can confidently chose active surveillance. Genomic provides New Mexico VA Health Care Systems (NMVAHCS), Southern Arizona VA Health Care System (SAVAHCS), Phoenix VA Health Care System (PVAHCS) and Northern Arizona VA Health Care System (NAVAHCS) Laboratory Departments with a report that summarizes the findings of the patients test. A detailed Oncotype DX assay report is generated for each patient. NMVAHCS, SAVAHCS, PVAHCS, and NAVAHCS are requesting one base year with three option years. NEW MEXICO VA HEALTHCARE SYSTEM (Base Year 10/1/2016 thru 9/30/2017) ITEM Estimated Number of Tests UNIT Price of Test Estimated Total Oncotype DX Breast CPT Code 81519 3 ea Oncotype DX Colon CPT Code 81525 1 ea Oncotype DX Prostate CPT Code 81479 1 ea Oncotype DX MMR CPT Code 88342 1 ea SOUTHERN ARIZONA VA HEALTHCARE SYSTEM (Base Year 10/1/2016 thru 9/30/2017) ITEM Estimated Number of Tests UNIT Price of Test Estimated Total Oncotype DX Breast CPT Code 81519 8 ea Oncotype DX Colon CPT Code 81525 3 ea Oncotype DX Prostate CPT Code 81479 1 ea Oncotype DX MMR CPT Code 88342 1 ea PHOENIX VA HEALTHCARE SYSTEM (Base Year 10/1/2016 thru 9/30/2017) ITEM Estimated Number of Tests UNIT Price of Test Estimated Total Oncotype DX Breast CPT Code 81519 8 ea Oncotype DX Colon CPT Code 81525 1 ea Oncotype DX Prostate CPT Code 81479 1 ea Oncotype DX MMR CPT Code 88342 1 ea NORTHERN ARIZONA VA HEALTHCARE SYSTEM (Base Year 10/1/2016 thru 9/30/2017) ITEM Estimated Number of Tests UNIT Price of Test Estimated Total Oncotype DX Breast CPT Code 81519 1 ea Oncotype DX Colon CPT Code 81525 1 ea Oncotype DX Prostate CPT Code 81479 1 ea Oncotype DX MMR CPT Code 88342 1 ea NEW MEXICO VA HEALTHCARE SYSTEM (Option Year 1: 10/1/2017 thru 9/30/2018) ITEM Estimated Number of Tests UNIT Price of Test Estimated Total Oncotype DX Breast CPT Code 81519 3 ea Oncotype DX Colon CPT Code 81525 1 ea Oncotype DX Prostate CPT Code 81479 1 ea Oncotype DX MMR CPT Code 88342 1 ea ITEM Estimated Number of Tests UNIT Oncotype DX Breast CPT Code 81519 8 ea Oncotype DX Colon CPT Code 81525 3 ea Oncotype DX Prostate CPT Code 81479 1 ea Oncotype DX MMR CPT Code 88342 1 ea ITEM Estimated Number of Tests UNIT Oncotype DX Breast CPT Code 81519 8 ea Oncotype DX Colon CPT Code 81525 1 ea Oncotype DX Prostate CPT Code 81479 1 ea Oncotype DX MMR CPT Code 88342 1 ea NORTHERN ARIZONA VA HEALTHCARE SYSTEM (Option Year 1: 10/1/2017 thru 9/30/2018) ITEM Estimated Number of Tests UNIT Price of Test Estimated Total Oncotype DX Breast CPT Code 81519 1 ea Oncotype DX Colon CPT Code 81525 1 ea Oncotype DX Prostate CPT Code 81479 1 ea Oncotype DX MMR CPT Code 88342 1 ea NEW MEXICO VA HEALTHCARE SYSTEM (Option Year 2: 10/1/2018 thru 9/30/2019) ITEM Estimated Number of Tests UNIT Price of Test Estimated Total Oncotype DX Breast CPT Code 81519 3 ea Oncotype DX Colon CPT Code 81525 1 ea Oncotype DX Prostate CPT Code 81479 1 ea Oncotype DX MMR CPT Code 88342 1 ea SOUTHERN ARIZONA VA HEALTHCARE SYSTEM (Option Year 2: 10/1/2018 thru 9/30/2019) ITEM Estimated Number of Tests UNIT Price of Test Estimated Total Oncotype DX Breast CPT Code 81519 8 ea Oncotype DX Colon CPT Code 81525 3 ea Oncotype DX Prostate CPT Code 81479 1 ea Oncotype DX MMR CPT Code 88342 1 ea PHOENIX VA HEALTHCARE SYSTEM (Option Year 2: 10/1/2018 thru 9/30/2019) ITEM Estimated Number of Tests UNIT Price of Test Estimated Total Oncotype DX Breast CPT Code 81519 8 ea Oncotype DX Colon CPT Code 81525 1 ea Oncotype DX Prostate CPT Code 81479 1 ea Oncotype DX MMR CPT Code 88342 1 ea NORTHERN ARIZONA VA HEALTHCARE SYSTEM (Option Year 2: 10/1/2018 thru 9/30/2019) ITEM Estimated Number of Tests UNIT Price of Test Estimated Total Oncotype DX Breast CPT Code 81519 1 ea Oncotype DX Colon CPT Code 81525 1 ea Oncotype DX Prostate CPT Code 81479 1 ea Oncotype DX MMR CPT Code 88342 1 ea NEW MEXICO VA HEALTHCARE SYSTEM (Option Year 3: 10/1/2019 thru 9/30/2020) ITEM Estimated Number of Tests UNIT Price of Test Estimated Total Oncotype DX Breast CPT Code 81519 3 ea Oncotype DX Colon CPT Code 81525 1 ea Oncotype DX Prostate CPT Code 81479 1 ea Oncotype DX MMR CPT Code 88342 1 ea SOUTHERN ARIZONA VA HEALTHCARE SYSTEM (Option Year 3: 10/1/2019 thru 9/30/2020) ITEM Estimated Number of Tests UNIT Price of Test Estimated Total Oncotype DX Breast CPT Code 81519 8 ea Oncotype DX Colon CPT Code 81525 3 ea Oncotype DX Prostate CPT Code 81479 1 ea Oncotype DX MMR CPT Code 88342 1 ea PHOENIX VA HEALTHCARE SYSTEM (Option Year 3: 10/1/2019 thru 9/30/2020) ITEM Estimated Number of Tests UNIT Price of Test Estimated Total Oncotype DX Breast CPT Code 81519 8 ea Oncotype DX Colon CPT Code 81525 1 ea Oncotype DX Prostate CPT Code 81479 1 ea Oncotype DX MMR CPT Code 88342 1 ea NORTHERN ARIZONA VA HEALTHCARE SYSTEM (Option Year 3: 10/1/2019 thru 9/30/2020) ITEM Estimated Number of Tests UNIT Price of Test Estimated Total Oncotype DX Breast CPT Code 81519 1 ea Oncotype DX Colon CPT Code 81525 1 ea Oncotype DX Prostate CPT Code 81479 1 ea Oncotype DX MMR CPT Code 88342 1 ea Estimated total for all VISN18: 1.5.0 Period of Performance: The period of performance shall be for one (1) Base Year of 12 months and three (3) 12-month option years. The Period of Performance reads as follows: Base Year: October 1, 2016- September 30, 2017 Option Year 1: October 1, 2017-September 30, 2018 Option Year 2: October 1, 2018-September 30, 2019 Option Year 3: October 1, 2019-September 30,2020 The Government reserves the right to extend the term of this contract at the prices set forth in Section B in accordance with the terms and conditions contained in clause 52.217-9 entitled, "Option to Extend the Term of the Contact". 1.6.0 General Information 1.6.1 Quality Control: The contractor shall develop and maintain an effective quality control program to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor's quality control program is the means by which he assures himself that his work complies with the requirement of the contract. As a minimum, the contractor shall develop quality control procedures that address the areas identified in Technical Exhibit 1, "Performance Requirements Summary". After acceptance of the quality control plan to be delivery one month after award the contractor shall receive the contracting officer's acceptance in writing of any proposed change to his QC system. 1.6.2 Quality Assurance: The government shall evaluate the contractor's performance under this contract in accordance with the Quality Assurance Surveillance Plan. This plan is primarily focused on what the Government must do to ensure that the contractor has 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). The contractor agrees to participate in an on-going Quality Assurance Surveillance Plan. 1.6.3 Government Remedies: The contracting officer shall follow FAR 52.212-4, "Contract Terms and Conditions-Commercial Items" or 52.246-4, "Inspection of Services-Fixed Price" for contractor's failure to perform satisfactory services or failure to correct non-conforming services. 1.6.4 Type of Contract: The government anticipates award of a firm fixed price, Indefinite Delivery Contract-Requirements type contract. 1.6.5 Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The contracting officer, Contracting Officers Representative (COR), and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the contracting officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government. 1.6.6 Contracting Officer Representative (COR): The COR monitors all technical aspects of the contract and assists in contract administration The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract: perform inspections necessary in connection with contract performance: maintain written and oral communications with the Contractor concerning technical aspects of the contract: issue written interpretations of technical requirements, including Government drawings, designs, specifications: monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies; coordinate availability of government furnished property, and provide site entry of Contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order. 1.6.7 Contract Manager/Liaison: The contractor shall provide a contract manager or liaison who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the contracting officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. 1.6.8 Licensing and ability to meet Accreditation Standards: Contractor shall have all licenses, permits, be able to meet accreditation and certificates required by law. 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) certifications. 1.6.9 The C&A requirements do not apply, a Security Accreditation Package is not required. Any privacy or information security breach will be immediately reported to the ABQ Privacy Officer and the ABQ Information Security Officer. 1.6.10 Records Management. The contractor shall be responsible for creating, maintaining and disposing of only those Government required records. If requested by the NMVAHCS COR, the contractor shall provide the original record, or a reproducible copy of any such record, within two (2) business days of receipt of the request. a. 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. b. 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. c. 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. d. 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. e. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. f. The Government Agency owns the rights to all data/records produced as part of this contract. g. 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. h. 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.]. i. 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. j. 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. 1.6.11Quality Assurance Monitoring A. Quality factors that VA may consider when monitoring quality of care may include, but are not limited to: patient medical records, security/privacy, adverse event reporting, turn-around times, timeliness to customer service requests, missed/delayed routes, etc. B. These monitoring procedures and disincentives for contractor's failure in meeting these tasks are further illustrated in the following Performance Requirements Summary Matrix: Task Standard Acceptable Quality Level Monitoring Method Testing services will be performed in accordance with the defined turn-around-times (TAT) Test results will be available within time contractor's laboratory reference test manual states or contractor will give written notification as to why there is a delay and the estimated time of delivery. 98% Periodic QA monitoring Billing/Invoices are to be appropriate costs outline in the contract Charges will be based on the contracted pricing and all discrepancies to pricing will be credited. 100% Observation and routine inspection of billing C. If the contractor believes there are excusable circumstances, the contractor shall inform the Contracting Officer and/or the COR. Excusable circumstances may result in adjustment of the disincentives established in the Performance Matrix based upon the Contracting Officer's Determination and Findings. PART 2 DEFINITIONS & ACRONYMS PWS - Performance Work Statement Contracting Officer's Representative (COR): A representative from the requiring activity assigned by the Contracting Officer to perform surveillance and to act as liaison to the contractor Defective Service. A service output that does not meet the standard of performance associated with it in the Performance Work Statement. Quality Assurance Surveillance Plan (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance. Quality Control. Those actions taken by a contractor to control the performance of services so that they meet the requirements of the PWS. Quality Assurance. Those actions taken by the government to assure services meet the requirements of the Performance Work Statement. National Comprehensive Cancer Network (NCCN) Veterans Integrated Service Network (VISN18): VISN 18 provides a comprehensive continuum of health care to veterans via 7 health care systems to include: Albuquerque-New Mexico VA Health Care System (NMVAHCS) Station Code 501 1501 San Pedro S.E., Albuquerque, New Mexico 87108-5128 Phoenix VA Health Care System (PVAHCS) Station Code 644 650 East Indian School Road, Phoenix, Arizona 85012-1892 Northern Arizona VA Health Care System (NVAHCS) Station Code 649 500 North Hwy 89, Prescott, Arizona 86313 Southern Arizona VA Health Care System (SAVAHCS) Station Code 678 3601 S 6th Ave., Tucson, AZ 85723