SOW.pdf

Statement of Work 2020 – Kayenta Health Center Molecular Biology Analyzer Winkelman, Kyle P. (IHS/NAV)

BACKGROUND

The Kayenta Health Center Laboratory Department, serving Native American and veteran patients in the Four Corners Area of the Southwest, is one of seven major Healthcare facilities in the Navajo Area I.H.S. The Kayenta Health Center Laboratory provides laboratory services to Dennehotso clinic and local school clinics.

The Kayenta Health Center Laboratory Department is requesting instrumentation, service and supplies for a molecular testing device. This analyzer should be capable of running multitarget respiratory panels, gastrointestinal panels, blood culture ID panels, and meningitis organism ID panels. These panels as currently designed, can be used to rule in or out pathogens in a variety of infectious diseases. It is necessary for the analysis and monitoring of all patients presenting to the unit as well as those patients presenting to our clinic in Dennehotso in the future. Kayenta Health Center currently utilizes a single module of this analyzer type, the system should be able double the capacity of samples going through the laboratory.

SCOPE

A singular automated molecular analyzer is available at the Kayenta Health Center Laboratory (Kayenta, AZ) currently. The current testing we have looks for respiratory pathogens (Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus, Human Rhinovius/Enterovirus, Influenza A (with differentiation of A H1-2009 and AH3), Influenza B, Parinfluenzas 1, 2, 3, and 4, Respiratory Syncytial virus, Bordatella pertussis, Bordatella parapertussis, Chlamyida pneumoniae, SARS-CoV-2, and Mycoplasma pneumoniae) and the Gastroinstestinal panel (Campylobacter, Clostridium difficile toxin A/B, Plesiomonas shigelloides, Salmonella, Vibrio species, Vibrio cholera, Yersinia entercolitica, Enteroaggregative E. coli, Enterpathogenic E. coli, Shiga-like toxin producing E. Coli (E.coli 0157) Shigella,Enteroinvasive E.Coli, Cryptosporidium, Cylcospora cayetanensis, Entabmoeba histolytica, Giardia lamblia, Adenovirus F40/41, Astrovirus, Norovirus GI/GII, Rotavirus A, and Sapovirus. This analyzer with the respiratory panel testing kit, will be vital in ruling out other potential pathogens in a SARS Coronavirus 19 evaluation. The new system should be able to do all of this same testing, but at least double the capacity of what the current laboratory analyzer is able to run (~20 samples per day).

OBJECTIVES

The analyzer will be used to perform molecular diagnostic tests required to maintain health and treatment of patients being served. The tests are needed within the same day to provide treatment decisions by the medical staff. Rapid identification of pathogenic organisms can lead to improved clinical outcomes and appropriate use of PPE precautions, thus reducing the spread of pathogenic organisms.

The Contractor will lease or purchase the analyzer through an equipment rental contract or purchase order with Kayenta Health Center (Indian Health Services) located in Kayenta, Arizona. Pricing should include the system itself, 12 month manufacturer warranty, 2 year extended warranty, barcode reader, and service support. The Contractor shall provide FDA-approved tests. A key operator training must be provided by the Contractor for onsite staff training. A service agreement shall be included on the contract to provide on-site service Monday through Friday, between 8 a.m. to 4 p.m.

The testing system should be able to perform:

1. Quality control performance every 30 days (or as determined by IQCP)

2. Capable of performing up to 40 test per day (depending on individual assay run time)

3. Positive patient identification via barcode scanner

DELIVERY

The person of contact for scheduling delivery of the analyzer is Dr. Katrina Leslie-Puhuyaoma, Acting Clinical Director, Acting Laboratory Supervisor, Kayenta Health Center (phone: 928-697-4237). If not available, please contact Kyle Winkelman, Lead Clinical Laboratory Scientist (Phone: 928-697-4140). Laboratory personnel must acknowledge receipt or delivery of reagents, supplies, or additional equipment. All receipt paperwork will be processed by the Kayenta Health Center Acquisitions & Procurement department.

Kayenta Service Unit - Laboratory

US Hwy 160 M.P. 394.3, Kayenta, Arizona 86033

GOVERNMENT-FURNISHED PROPERTY/EQUIPMENT

No government furnished property or equipment is provided by Kayenta Health Center for operation of the analyzer.

SECURITY REQUIREMENTS

Security requirements associated with contract performance will require the vendor check in with the security desk and be issued a temporary ID badge, special pass, or special clearance. The laboratory will be assessable only by scanning badges of hospital employees, thus, a laboratory staff member will escort the vendor to the area for analyzer maintenance, or other contract related business.

PLACE OF PERFORMANCE

Kayenta Health Center-Laboratory

US Hwy. 160 M.P. 394.3

Kayenta, Arizona 86033

PERIOD OF PERFORMANCE

BASE YEAR

09/1/2020 – 8/31/2021

OPTION YEAR 1

09/1/2021 – 8/31/2022

OPTION YEAR 2

09/1/2022 – 8/31/2023

DAYS AND HOUR OF OPERATION: 7 DAYS PER WEEK (Monday- Sunday), 24 hours per day, holidays included.