P01 - DRAFT - Alinity m Reagents - SOW.rtf

DRAFT - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

BACKGROUND

The Government’s requirement is to obtain a base-plus-3-year reagent/supply random-access multiplex testing for the Abbott Alinity m analyzer within the Department of Pathology and Laboratory (PLM) at Iowa City VA HCS.

SCOPE OF PROCUREMENT

This agreement is to include any required amp Kit, control Kit, calibration Kit, and consumables required to operate the instrument. Reagents and supplies provided must be FDA cleared for use and meet the performance characteristics for accuracy and precision as defined by the Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI – formerly NCCLS), when applicable.

Assays should provide the quantitative, semi-quantitative, or qualitative determination of the following:

Must accept ThinPrep PreservCyt Solution and SurePath Preservative Fluid

Must have de-capping/transferring/labeling capabilities Must have self-collect claims for specimen collection for HPV STI Panel (as a “4 plex” or multiplex option) Chlamydia trachomatis (CT) (included specimen types: urine, endocervical, vaginal self or provider collected, rectal, oropharyngeal)

SARS-COV-2 (COVID)

Influenza A (FluA) Influenza B (FluB) Respiratory Syncytial Virus (RSV)

CONSUMABLES

Test kits must be FDA approved for analysis on Abbott Alinity m analyzer.

To include all reagents/expendables that will are required for routine operation and resulting for the above listed assays.

All reagents should have the longest outdates possible, contractor will guarantee a minimum of four months, and the ICVA can request the longest outdate available upon order.

SDS – Safety Data Sheets are required. Any product formulation changes must be accompanied with an updated SDS.

The contractor shall notify, within 24 hours, the appropriate laboratory personnel regarding any recalled reagents. This must be accomplished by telephone and/or certified email/regular mail. The vendor will provide sufficient replacement items to resolve the problem so that there is no break in service experienced. Contractor will support use of alternative reagents if required due to recall or multiple performance issues or cover the cost of testing required to be sent out during service disruption.

The test kits will be shipped and replenished in quantities as requested by the laboratory. The laboratory will request the kits on an as-needed basis. ICCA will be invoiced for delivery orders. The Contractor will provide direct delivery to the lab at the contractor’s expense. The Laboratory department will order using their usual procedures and referencing the purchase agreement pricing.

All products must be tested for quality control by the manufacturer. Only products that pass will be sent to Iowa City VAHCS. The contractor will demonstrate documentation of quality control performance on any item upon request including Certificate of Analysis/Analytical Standard Certificates of Quality /Chemical Data Sheets, when applicable.

Substitution of product may not be made without the approval of the VA Medical Center Laboratory Service and Contracting Officer.

All defective or inferior products must be replaced within 48 hours at no cost to the VA Medical Center Laboratory Service.

Items required: (estimated annual usage based on previous history):

Base Year, Option Years One, Two, Three, and Four Item # Part number Description Qty 08N50-095 Alinity m HCV AMP Kit 08N50-075 Alinity m HCV CAL Kit 08N50-085 Alinity m HCV CTRL Kit 08N45-095 Alinity m HIV-1 AMP Kit 08N45-075 Alinity m HIV-1 CAL Kit 08N45-085 Alinity m HIV-1 CTRL Kit 09N61-095 Alinity m HSV 1 & 2 / VZV AMP Kit 09N61-085 Alinity m HSV 1 & 2 / VZV CTRL Kit 09N15-095 Alinity m HR HPV AMP Kit 09N15-085 Alinity m HPV CTRL Kit 09N49-010 Alinity m Transport Tube Pierceable Cap (1500 per bx) 09N17-095 Alinity m STI AMP KIT (CT, NG, TV & MG results) 09N17-085 Alinity m STI CTRL KIT 09N19-015 Alinity m Multi-collect SP 09N79-095 Alinity m Resp-4-Plex AMP Kit 09N79-085 Alinity m Resp-4-Plex CTRL Kit 09N18-001 Alinity m SAMPLE PREP KIT 1 09N12-001 Alinity m SAMPLE PREP KIT 2 09N20-001 Alinity m LYSIS SOLUTION 09N20-012 Alinity m Bottle and Cap Kit for ETHANOL USE 09N20-003 Alinity m DILUENT SOLUTION 09N20-004 Alinity m VAPOR BARRIER S 09N26-001 Alinity m PIPETTE TIPS 50 09N26-002 Alinity m PIPETTE TIPS 10 09N26-010 Alinity m INTEGR REACTION UNIT 09N26-012 Alinity m WASTE BOX 09N26-020 Alinity m IRU WASTE CONTAINER

Estimated shipping and handling charges

The annual quantity is only an estimate. Volumes may vary during the life of the agreement.

Contractor will supply a quarterly report to the Contracting Officer’s Representative (COR) that indicates the products and quantities purchased each month. The report will consist of a breakdown which includes: the facility name, products obtained under this agreement, and the volume per month.

All pricing includes FOB destination with 2-day shipping upon order.

In the case of a company merger and/or acquisition, contractors, will immediately notify the Contracting Officer for this BPA and provide a contingency plan of services to assure that no break in service is experienced.

DELIVERY

Deliveries will be made Monday through Friday between the hours of 8:00 AM and 4:00 PM, federal holidays exempt.

Holidays observed by the Federal Government are as follows:

Juneteenth

Note: If the federal holiday falls on a Saturday it will be officially observed on the Friday before the holiday. If the holiday falls on a Sunday, it will be officially observed on the Monday following the holiday.