SOW Rapid PCR.doc

Statement of Work

1. Task Order Title/Description of Service: Department of Pathology is requesting an equipment rental and supply contract for a Rapid (~ 20 minute) CLIA waived Polymerase Chain Reaction (PCR)/Nucleic Acid Amplification Test (NAAT) analyzer(s) for rapid identification of Influenza A & B, SARS-CoV-2, Respiratory Syncytial Virus (RSV), and Streptococcus Group A. Contractor must be able to perform the required scheduled maintenance and provide customer with all hardware and software upgrades to maintain the integrity of the system. The Contractor must be available to perform emergency services within 24 hours of service call and be completed within 48 hours of arrival. Contractor must also follow any requirements dictated by the AT/OPSEC Standard Contract Provision.

2. Background: The COVID-19 Pandemic has challenged the Clinical Microbiology Laboratory with increasing numbers of SARS-CoV-2 tests being performed but fewer Influenza, RSV, and Streptococcus tests. Supply constraints and allocations have also complicated management of contracts and ability to provide laboratory support of patient care. As the Pandemic evolves and historical pathogens (Influenza) become prevalent the laboratory must be prepared. This is met with rapid, easy to use, PCR testing.

3. Objectives and Scope: To maintain the latest instrumentation to provide quality patient care. Maintain state of the art equipment for use in pathogen identification and treatment.

a. Contractor shall provide key operator training in the proper use of the instrument as part of the contract. Training shall be coordinated with the COR and in conjunction with the installation of the equipment. Training shall include system operations, data manipulation and basic trouble shooting and repair. If training is to be conducted off site, it should be for no less than 2 individuals and at no cost to the government.

b. The contractor shall provide applicable manuals and schedules upon delivery and installation of equipment. Contractor shall perform preventive maintenance inspections during the contract period arranged with the COR in accordance with the published preventive maintenance manuals for the equipment. Contractor shall utilize the original equipment manufacturer’s established preventative maintenance procedures and checklists. A field service report shall be supplied to the COR at the completion of each preventative maintenance inspection and at the completion of any unscheduled maintenance request. If the repair of any individual piece of the contractors equipment reflects a downtime of 5% or greater of the normal working days in a single calendar month from the time of dispatch, the designated representative may make a determination to have the contractor replace the malfunctioning equipment with new equipment at no charge to the government. The contractor is ultimately responsible for ensuring its equipment is furnished in good condition in accordance with manufacturer’s instructions. This facility is ultimately responsible for ensuring the manufacturers recommended daily, weekly, monthly and periodic maintenance is performed. Vendor must provide upgrades to both the hardware and software in order to maintain the integrity of the system and the state of the art technology at no additional charge.

c. Contractor shall provide all accessories required to fully operate the analyzer. In addition, the contractor shall include all ancillary components customarily provided with the model of equipment furnished to Madigan Army Medical Center, e.g. starter kits. It will also include the necessary test kits to perform a verification upon arrival of the equipment at Madigan.

4. Government Furnished Items: NONE

5. Specific Tasks:

The contractor shall provide:

a. Analyzer(s) with all components and accessories.

b. All required maintenance, scheduled and unscheduled as well as emergency service calls as stated in paragraph 1.

c. An itemized list of all components by make, model and serial number for accountability purposes.

d. Must be able to obtain an ATO to operate on the DHA network within 2 years following start of contract and meet cyber security/network requirements.

e. Interface for host connection to Laboratory Information System (LIS) and system must be capable of automatically sending patient results to the LIS.

f. All test kits (reagents) needed to complete the required verification of the analyzers at no cost to the government.

g. The contractor shall provide the following assays that are either FDA approved or have been granted an Emergency Use Authorization.

1. Influenza A/B/SARS-CoV-2 (4,000 tests)

2. Influenza A/B/RSV (500 tests)

3. Streptococcus A (500 tests)

h. The contractor shall provide enough controls for the assays listed in line “g” to be performed upon receipt of supplies and monthly thereafter.

i. The contractor shall provide the necessary number of analyzers and supporting equipment in order to run a minimum of three tests simultaneously.

6. Place of Performance:

Madigan Army Medical Center

Attn: Microbiology, Department of Pathology Tacoma, WA 98431

7. Period of Performance: TBD

8. Government Point of Contact: TBD