Attachment 2. CKD Statement of Work.pdf

Statement of Work

Description/Scope/Objectives

The Pathology & Laboratory Medicine Service of the Miami VAMC has a requirement for a source for gene testing for chronic kidney disease (CKD). Contractors shall meet the minimum requirements of deliverables below.

The Contractor must provide all labor, equipment, tools, material, supervision and other items and services necessary to perform the work as defined in this Statement of Work.

The following laws, regulations, policies, and procedures in effect on date of contract issuance and all subsequent changes or updates apply:

FAR Federal Acquisition Regulation

VAAR Veterans Administration Acquisition Regulation

The contractor shall be able to perform the required tests for the facility listed in the below and be incompliance with the College of American Pathology (CAP), and/or the Joint Commission (TJC) standards, and Clinical Laboratory Improvement Amendments (CLIA) (Public Law 100-578) certifications.

Performance Requirements

Kidney Gene panel for patients with chronic kidney disease (CKD) that is comparable to the Renasight Kidney Gene Panel.

Shall test customized panel of chromosomal/DNA alterations associated with CKD in adults.

Shall test at least 385 genes associated with chronic kidney disease (CKD).

Have implications on candidacy for transplant of kidney donation.

Shall provide consultation to assist providers understand the cause or risk of progression of kidney disorders that are typically uncommon and are considered “idiopathic”.

Specimens shall only be used for the CKD panel.

Vendor shall be able to accept both blood and saliva samples.

Vendor shall be able to provide interactive assistance with test building with no charge to Pathology and Lab services; This during the start-up phase.

Primary place of performance is the Bruce W. Carter, Miami VA Medical Center, 1201 16th Street, Miami, Florida, 33125. Pathology, Room A-305. Government normal duty hours are from 8:00am to 4:30pm, Monday through Friday, excluding Federal holidays. Pathology& laboratory Medicine Service provide diagnostic support to this facility 24 hours daily, 7 days per week, including holidays. Contractor access will be provided during this timeframe if required.

The contractor shall provide all labor, equipment, supplies and other items and services required to perform requested test procedures not currently performed at the Pathology & Laboratory Medicine Service at Miami VA Healthcare System.

The contractor shall be able to report test results back to the facility in electronic format in a time frame that is commercially acceptable for that test, no later than 21 days from sample arrival. The referral lab should provide any/all special collection containers necessary to be compatible with the methodologies of the tests performed at your facility.

The contractor shall be able to provide transportation of test kit from our main laboratory Monday through Friday between the hours of 8am to 4pm via courier or prepaid shipping label and shipping supplies. Insurance and shipping costs shall be at the expense of the vendor. If vendor chooses to ship, in any event of loss or damaged samples, the vendor will re-test an no additional charge.

If vendor chooses to use a courier, the courier shall sign a log documenting who picked up specimens, time of pick-up, and number of specimen bags including storage condition at that time. This will be done at the time of pick-up.

When supplies are needed, they are delivered within two business days of order under normal circumstances. Supplies under emergency circumstances shall be determined as needed, with delivery within industry accepted time for the circumstance.

Vendor shall be able to provide statistics on specimen transport, integrity, and acceptability;

Vendor should be able to demonstrate a limitation of specimen interactions by external entities that are not affiliated with the vendor or the Pathology and Laboratory Medicine Services.

Non-Personal Service Statement

Contractor employees performing services under this order will be controlled, directed, and supervised at all times by management personnel of the contractor. Contractor management will ensure that employees properly comply with the performance work standards outlined in the PWS. Contractor employees will perform their duties independent of, and without the supervision of, any Government official. The tasks, duties, and responsibilities set forth in the contract may not be interpreted implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the United States Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulation (FAR). The Government will control access to the facility and will perform the inspection and acceptance of the completed work.

VA INFORMATION CUSTODIAL LANGUAGE

Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

The contractor/subcontractor shall store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.