Attachment 1 SOW Molecular Diagnostic Testing - Comprehensive 21-002304.pdf

Statement of Work (SOW)

Department of Laboratory Medicine (DLM) version 02/10/2021

Molecular Diagnostic Testing – Comprehensive

TABLE OF CONTENTS

1.0 Introduction 2

1.1 Background 2

1.2 Scope 2

1.3 Objectives 2

2.0 Requirements 3

2.1 Tasks 3

2.2 Deliverables 3

2.3 Schedule 4

2.4 Assumptions 4

3.0 Government Furnished Property 4

4.0 Security Requirements 4

1.0 INTRODUCTION/OVERVIEW

The National Institutes of Health (NIH) Clinical Center is a 200-bed biomedical research hospital. The Department of Laboratory Medicine (DLM) serves as the clinical laboratory of the NIH Clinical Center and performs a variety of standard and specialized laboratory tests, reporting over 1.5 million results per year.

1.1 BACKGROUND

Because of the unique research role of the NIH, in addition to the laboratory testing provided by the DLM, there is also a need for outside laboratory contractors to perform highly specialized molecular diagnostic testing for many diseases to support and augment

DLM’s in-house test menu. This “send-out” or reference laboratory testing provides support for ongoing research and clinical trials for several Institutes including, but not limited to, the National Cancer Institute (NCI), the National Institute for Child Health and

Human Development (NICHD), the National Human Genome Research Institute

(NHGRI), and the National Institute for Neurological Disease and Stroke (NINDS).

Specifically, there is a need at the NIH for comprehensive molecular diagnostic testing for diseases such as hereditary cancers, neurodevelopmental disorders, and primary immunodeficiencies. Due to the long term natural history research studies and inherent future testing needs of offspring from an affected parent patient, molecular diagnostic methods need to remain uniform over time to ensure consistency of results and continuity of patient/descendant care.

1.2 SCOPE

This requirement is for the performance of offsite comprehensive molecular diagnostic testing that shall include the capability to provide electronic ordering and secure transfer of test results into the patient’s NIH medical record.

1.3 OBJECTIVES

Establish a single account for comprehensive molecular diagnostic testing with a reference laboratory, to ensure that the government receives any discounts associated with volume pricing. Establish a working interface between the vendor’s laboratory information system and the DLM laboratory information system, which is Soft Computer

(SCC).

2.0 REQUIREMENTS

2.1 TASKS

The reference laboratory shall furnish all the necessary services, qualified personnel, supplies, materials, equipment, software and facilities not otherwise provided by the government, as needed, to perform the work set forth below:

A. The contractor shall demonstrate capability to perform molecular diagnostic testing for the battery of tests listed in the deliverables section 2.2 below.

B. This contract requires the operation of a system of patient records. Thus, the

Privacy Act requirements are applicable. The contractor and its employees are subject to criminal penalties for violations of the Act (5 U.S.C. 552a (I)). Hence, the contractor shall assure that its employees abide by prescribed rules of the

Privacy Act.

C. The contractor will accept at minimum whole blood, DNA, RNA, saliva and other non-fixed tissue samples for extraction performed at the contract laboratory.

D. The contractor will possess an extensive database of disease variants for the purpose of comparison and contrast over multiple years as needed for NIH research protocols.

E. The contractor shall provide raw data to the government upon request, for each test performed. The contractor shall possess all necessary hardware to store government data for no less than 5 years.

F. The contractor shall have laboratory certification consistent with Clinical

Laboratory Improvement Act (CLIA) 1968 and CLIA 1988, to perform these molecular diagnostic tests. The current copy of the CLIA certification should be submitted with the response to this proposed contract. The contractor shall provide, annually, copies of certificates as evidence of CLIA certification and inspection by accrediting agencies. If subcontractors are utilized, the contractor shall submit the subcontractor’s laboratory certificates as evidence of CLIA compliance.

G. The contractor shall provide strong technical advice relative to the interpretation of data and expert consultation services during their normal operating schedule.

This includes the availability of staff members who are board certified clinicians with expertise in clinical genetics.

H. The contractor shall provide all resources necessary to establish and maintain (for at least one year) a bidirectional VPN interface between the contractor’s information system and the DLM’s SCC SoftLab information system for the purpose of receiving orders and sending results. Order and results must be securely transmitted between the electronic systems to ensure the privacy of patient’s personally identifiable information (PII) and test results. A working interface shall be live within 120 days of the award of this contract.

2.2 DELIVERABLES

A. The contractor shall provide testing in at least 7 of the 10 categories listed below:

1. Exome sequencing

2. Genome sequencing

3. Gene panels

4. Pharmacogenetic genotyping

5. Targeted analysis (single or multiple variants)

6. Hereditary cancer syndromes

7. Mitochondrial disorders

8. Sanger sequencing validation

9. Somatic mutation testing

10. Custom sequencing

B. Requests for molecular diagnostic testing and transmission of specimens for testing will originate from the requesting Institute/LIP (licensed individual practitioner). The contractor will provide adequate information regarding specimen collection requirements including volumes and specific collection tubes as well as catalogs, interpretation manuals and on-line computer assistance or web sites for proper specimen collection and test methodologies.

C. The contractor shall transmit all results to the DLM no later than the business day which follows the documented date of test completion. If additional hard copies of the test result are requested by the DLM, the contractor shall provide hard copy reports within 3 calendar days of the request.

D. Result reports from the contractor must, at a minimum, include the following information: patient medical record number, patient first name, patient middle initial, patient last name, patient date of birth, ordering physician first and last name, test name, test code, specimen collection date, specimen receipt date, result date, result, result interpretation and the name and address of the performing laboratory.

E. Invoices from the contractor must, at a minimum, include the following information: patient medical record number, patient first name, patient middle initial, patient last name, ordering physician first and last name, test name, test code, specimen receipt date, number of tests performed, cost of each test, total cost per patient, and the contractor’s DUNS#.

F. The contractor shall provide specimen transport services from DLM to the off-site laboratory and vice versa for delivery and/or return of samples, as needed. Specimen transport personnel shall be properly trained by the contractor in the handling and shipment of biohazardous specimens. The contractor shall be able to provide documentation of all transport personnel’s annual training upon request.

G. Corrected result reports must be annotated as “corrected” and contain the previous result (including interpretation), the revised result (including interpretation), and the date each test was performed.

H. The contractor shall provide at least thirty (30) days advanced written notification of any changes which will be made to test methods, reference ranges, test interpretations, or discontinuation of testing. The thirty day timeline is calculated from the time the written notification is received by the

Contracting Officer’s Representative (COR) to the effective date of the change.

I. The contractor will provide same day customer service via telephone in support of their testing during the contractor’s normal business hours. The contractor will include all contact phone numbers and operating hours in its proposal.

J. The contractor shall be able to provide to the COR a quality control report which includes turnaround time measures for each test performed, upon request.

K. The contractor shall provide to the COR a monthly test utilization report which includes, at a minimum, the test code/ID, test name, the contracted test price, and the number of each test performed (separated by both year-to-date data and previous month data. Reports shall be emailed to the COR within 15 business days of the last day of the previous month.

2.3 SCHEDULE

Period of performance for this contract is anticipated as follows:

Base: 7/1/2021 – 6/30/2022

Option 1: 7/1/2022 – 6/30/2023

Option 2: 7/1/2023 – 6/30/2024

Option 3: 7/1/2024 – 6/30/2025

Option 4: 7/1/2025 – 6/30/2026

Location of performance:

All activities will be performed at the Contractor’s off-site location or at the location of any subcontracted laboratories. The Contractor shall provide all testing site location information in their proposal.

Location of on-site meetings with the Government:

For any on-site meetings that are scheduled to assess the performance of this contract, the

Contractor’s representatives should report to:

NIH Clinical Center, Department of Laboratory Medicine

Building 10, Room 2C-306

10 Center Drive

Bethesda, MD 20892

Contract Officer’s Representative (COR)

Heather Crum, Laboratory Manager

NIH Clinical Center, Department of Laboratory Medicine

Building 10, Room 2C-306

10 Center Drive

Bethesda, MD 20892

Phone: (301) 402-3364

Email: heather.crum@nih.gov

3.0 GOVERNMENT FURNISHED PROPERTY

A. The Government (as represented by a responsible NIH LIP) shall provide the contractor with all required test, patient, and account # information, including special forms, as indicated.

B. The Government (as represented by a responsible NIH LIP) shall provide a properly collected and labeled patient specimen, in accordance with the instructions and specimen transport containers provided by the contractor.

C. Any applicable Government computer training will be provided by the

Government. HHS policy requires contractors/subcontractors to receive security and privacy training commensurate with their responsibilities for performing work under the terms and conditions of their contractual agreements.

4.0 SECURITY REQUIREMENTS

Any contractor representative who requires access to the NIH campus for on-site meetings, specimen transport, or other purpose shall follow standard NIH visitor security procedures, including but not limited to, providing a photo ID that is acceptable for use at a Federal facility (note: some State photo IDs do not meet Federal ID requirements).