Attachment B.docx

Attachment B

SOW

SARS-CoV-2 Reagents

1. Introduction

The purpose of this Statement of Work (SOW) is to outline the tasks and responsibilities of the successful offeror in relation to the VISN 22 Pathology and Laboratory Medicine Service for SARS-CoV-2 reagents.

1.1 Background

The Desert Pacific Healthcare Network (VISN 22) is one of the most diversified tertiary health care providers in the VA. It consists of teaching hospitals, providing a full range of patient services, with state-of-the art technology as well as education and research. It also boosts one of the largest and most diverse patient populations in the VA system. The ability to maintain rapid testing for SARS-CoV-2 is essential to our healthcare system’s operation.

2. Scope

The vendor shall supply kits that are equal to or equivalent to the Cepheid reagents listed below:

SARS-CoV-2 Assay and SARS-CoV-2/Influenza/RSV must be fully compatible with all features, must physically fit without alteration, and not void the preventive maintenance and service or warranty of the current VA-owned and leased Cepheid GenXpert systems:

SARS-CoV-2 single Assay must be EUA FDA approved for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab or anterior nasal swab specimen obtained from individuals meeting COVID-19 clinical and/or epidemiological criteria, as well as individuals without symptoms or other reasons to suspect COVID-19 infection.

SARS-CoV-2, Influenza A, Influenza B and Respiratory Synytial Virus plus must be EUA FDA approved for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A, influenza B, and/or respiratory syncytial virus (RSV) in either nasopharyngeal swab, anterior nasal swab or nasal wash/ aspirate specimens collected from individuals suspected of respiratory viral infection, consistent with COVID-19, by their healthcare provider.

Both assays shall have a run time of forty-five minutes or less and function and compatible with current Cephied reagent analyzers.

A minimum allocation of 4080 tests will be provided to VISN22 laboratories on a weekly basis. Delivery of items and quantities are subject to changed based on the demand of VA Hospital needs.

Below is a list of participating facilities:

VA Greater Los Angeles Healthcare System West LA Campus (VAGLAHS) 11301 Wilshire Blvd Los Angeles, CA 90073

VA Long Beach Healthcare System (VALBHS) 5901 E. 7th Street Long Beach, CA 90822

VA Loma Linda Healthcare System (VALLHS) 11201 Benton Street Loma Linda, CA 92357

VA San Diego Healthcare System (VASDHS) 3350 La Jolla Village Dr. San Diego, CA 92161

VA New Mexico Healthcare System (VA Albuquerque) 1501 San Pedro SE Albuquerque, NM 87108

VA Northern Arizona Healthcare System (VA Prescott) 500 Hwy 89N Prescott, AZ 86313

VA Southern Arizona Healthcare System (VA Tucson) 3601 S. 6th Ave Tucson, AZ 85723

VA Phoenix Healthcare System (VA Phoenix) 650 E. Indian School Road Phoenix, AZ 85012

3. Hours of Operation

· Normal tour-of-duty hours are 7:30 am to 5:00 pm, Monday through Friday, excluding Federal holidays. However, the service is operating 24/7 and as such there may be instances in which the vendor’s workday may be outside of this period. The vendor is required to coordinate these times with the designated Program Manager.

· In accordance with 5 U.S.C. 6103, Executive Order 11582 and Public Law 94-97 the following national holidays are observed and for the purpose of this contract are defined as “Legal Federal official holidays”

When a holiday falls on a Sunday, the following Monday will be observed as a National Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National Holiday by U.S. Government Agencies.

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Salient Characteristics

· SARS-CoV-2 Assay and SARS-CoV-2/Influenza/RSV must be fully compatible with all features, must physically fit without alteration, and not void the preventive maintenance and service or warranty of the current VA-owned and leased Cepheid GenXpert systems:

· GENEXPERT XVI Dx R1

· GENEXPERT XVI Dx R2

· GenXpert Infinity

· SARS-CoV-2 Assay must be EUA FDA approved for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab or anterior nasal swab specimen obtained from individuals meeting COVID-19 clinical and/or epidemiological criteria, as well as individuals without symptoms or other reasons to suspect COVID-19 infection.

· SARS-CoV-2, Influenza A, Influenza B and Respiratory Synytial Virus plus must be EUA FDA approved for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A, influenza B, and/or respiratory syncytial virus (RSV) in either nasopharyngeal swab, anterior nasal swab or nasal wash/ aspirate specimens collected from individuals suspected of respiratory viral infection, consistent with COVID-19, by their healthcare provider.

· SARS-CoV-2 Assay and SARS-CoV-2/Influenza/RSV must not negatively impact system performance, assay results, safety, and equipment life cycle of the current VA-owned and leased Cepheid GenXpert systems.

· Both assays must have a run time of forty-five minutes or less and function and compatible with current Cephied reagent analyzers.

· A minimum allocation of 4080 tests will be provided to VISN22 laboratories on a weekly basis. Delivery of items and quantities are subject to changed based on the demand of VA Hospital needs.

· Ambient temperature transport system and storage of reagents.

· Pricing must include all handling, HAZMAT, dry-ice and shipping fees when applicable.

The information identified above is intended to be descriptive, not restrictive and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications.

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