Attachment 1 - SOW.docx

DEPARTMENT OF VETERANS AFFAIRS

VA MEDICAL CENTER, SALT LAKE CITY, UT

STATEMENT OF WORK

Transplant Rejection Detection Molecular Genetic Testing

Introduction Department of Veterans Affairs, Veterans Health Administration, Salt Lake City VA Medical Center (VAMCSLC), 500 Foothill Drive, Salt Lake City, Utah 84148 has a requirement for molecular genetic testing for transplant rejection. The contract will be awarded as a firm fixed price contract for one base period with four optional renewal periods.

Scope of Work The Contractor will provide diagnostic laboratory services that monitors transplant patients and enables a timely detection of organ rejection to improve patient outcome, through molecular expression genetic blood testing, which will detect organ rejection, guide treatment and support patient care.

Description The contractor shall be responsible for performing laboratory testing, analysis, and result interpretation on behalf of the VAMSLC facility in accordance with the terms, conditions, and provisions outlined thereof. These services shall include the performance of molecular analytical testing as defined by the contractors reference test manual, the reporting of molecular analytical test results, and consultative services as required to assimilate the full scope for patient care.

The services performance shall include specialized molecular analytical testing with varying levels of support services depending on the unique characteristics presented by each individual ordering activity.

The contractor shall perform testing entirely upon their premises.

Tests will be performed and reported within established vendor turnaround times.

The contractor shall carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations as they pertain to a licensed clinical laboratory.

The contractor shall provide individual patient-chartable test result reports meeting Clinical Laboratory Improvement Amendments (CLIA) requirements.

The contractor shall provide all appropriate requisition forms and unique supplies needed for specialized collection of samples, at no additional charge.

Notwithstanding, anything to the contrary in this Agreement or otherwise,The contractor shall not release patient records that include test results, without the specific written consent to release such information as provided by the patient, to any person other than the ordering healthcare provider or designee. All patient records shall be treated as confidential so as to comply with all state and federal laws regarding the confidentiality of patient's records. This provision shall survive termination of this Agreement.

The required highly specific molecular testing reference laboratory services include but are not limited to the identified required test menu testing, specimen preparation and storage of clinical laboratory specimens, performance of analytical testing; reporting of analytical test results; and consultative services.

Schedule of Services Description/Part Number

Molecular expression transplant assessment testing

Molecular Assessment for Kidney Disease

Molecular Genetic Prenatal Screening Test

General Requirements The contractors standard price list of all testing services available along with the price to be billed to the VHA for each testing service shall reflect that which is listed in their GSA price list.

The price list, at a minimum, shall include the following data elements:

CPT code Product Name/Description Price Test description, including reference ranges and units of measurement Maximum turn-around-time (TAT) shall not exceed three weeks from specimen submission.

Test Result Reporting

The Contractor shall provide encrypted and/or secured electronic transmission (i.e., fax and/or on-line web access) of all completed and/or partial test results to the ordering activity within published turnaround time (TAT), except where specified. (See 5.2. of Contractor’s Responsibilities).

Mandatory Requirements Licensing and Accreditation: Only fully licensed and accredited laboratories actively engaged in providing the specific services and laboratory testing outlined. The contractor shall have all licenses, permits, accreditation and certificates required by law. The reference laboratory must be licensed and accredited by the College of American Pathologists (CAP) and/or other state regulatory agencies as mandated by federal and state statutes. In addition, the laboratory must be certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Amendments of 1988.

The contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America prior to contract award. In addition, the contractor shall be responsible for providing a written guarantee or evidence that all subcontractors have appropriate licensure and accreditation to perform tests that the primary contractor cannot perform prior to contract award. Any proposed subcontractor changes during the contract performance period must have prior approval by the Contracting Officer (CO).

The Contractor policies and procedures shall comply with Health Insurance Portability and Accountability Act (HIPAA).

The contractor will provide and maintain quality assurance programs which meet federal regulations for laboratory operations. The contractor will be certified by the College of American Pathologist under the CLIA.

The contractor shall notify the contracting officer in writing of any malpractice investigation or licensure or certification suspension which concerns the contractor or any employees, within 24 hours of notification of an investigation or suspension.

Contractor Personnel: The contractor shall maintain current accreditation and notify the Contracting Officer of any lapse in state license, CLIA certification, or clinical pathology certification. The contractor shall provide a copy of renewed licenses/certificates to the Contracting Officer before expiration.

Contractors Responsibilities Procedure Guidance:

The testing methodology and reference ranges for a test must be defined and available electronically. The contractor shall provide change notice prior to implementation of any new medical procedures and services.

The contractor shall ensure that all procedures performed are of current acceptable standard deviation with at least (minimum) daily controls conducted to determine procedure accuracy. Upon request by the Contracting Officer (CO) and / or Laboratory Point of Contact (POC), the contractor will make available quality assurance information on specific testing procedures for review.

In the event of tests being referred to another laboratory, there shall be no additional transfer charge or confirmation charge to the government.

Reporting of Results:

A testing report is defined as a printed final copy of laboratory testing results. The report(s) shall be available on an encrypted and/or secured electronically with on-line web access and /or secured facsimile (Fax).

Each test report shall at minimum indicate the following information:

Retention of Specimens:

Upon completion of the testing procedures, the contractor shall retain all specimens as required by regulatory agencies. Upon request by the ordering activity COR or designee, the contractor shall provide a copy of the regulatory requirements for each participating regulatory agency. In the absence of regulatory agency requirements, the contractor shall retain specimens, after all testing has been completed for clinical specimens (7) days.

Term of the Contract

This agreement is effective for five years estimated to begin January 2027.

Qualifications/Requirements of Laboratory & Contractor Personnel

Laboratory:

The contractor to including subcontractor(s), must continuously hold a Certificate of Compliance or Certificate of Accreditation from the Centers for Medicare & Medicaid Services as meeting the requirements of the CLIA of 1988, or must demonstrate accreditation by a regulatory agency(s) with deemed status from the College of American Pathologists, and/or other state regulatory agencies, as appropriate, and as mandated by federal and state statutes. The reference laboratory must maintain valid certifications during the entire performance period of this contract.

Copies of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America must be supplied in response to this procurement action. In addition, as these documents are reissued or re-awarded, the awarded contractor must supply a copy to the Contracting Officer and/or POC assigned to the servicing Government facility. The above documents must also be supplied for each reference laboratory that is a subcontractor of the primary contractor.

The contractor must notify immediately the Contracting Officer in writing, upon its loss of any required certification, accreditation, or licensure.

The contractor shall maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention.

Contractor’s Personnel The contractor shall ensure all testing and supervisory personnel at all contractor-owned, affiliate, or subcontracted laboratories assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the CLIA of 1988 regulations.

Contractor shall ensure its employees have the ability to perform the applicable duties consistent with their license and certification.

Personnel assigned by the contractor to perform the services covered by this contract shall be proficient in written and spoken English (38 USC 7402).

The contractor shall comply with any new regulatory requirements for mandatory education and/or competency assessment, which occur during the contract period. These items must be completed by the individual contractor employee(s) within a mutually agreed upon timeframe between the Government and the Contractor.