Molecular Diagnostics Equipment

Added: May 30, 2018 5:49 pm This announcement constitutes a Pre-Solicitation notice for the Regional Contracting Office - Central.

The following information is provided to assist with Molecular Diagnostics Laboratory mission at San Antonio Military Medical Center (SAMMC) which supports surrounding clinics/healthcare network and military treatment facilities worldwide. The period of Performance is a base period plus four (4) option periods (01 October 2018 - 30 September 2023.)

The applicable North American Industrial Classification System (NAICS) code is
325413, In-vitro diagnostic test substances manufacturing. The Small Business Administration's size standard for NAICS 325413 is 1250 employees. This will be a full and open competitive requirement. 

Requirement: The Contractor shall provide two (2) fully automated polymerase chain reaction (PCR) systems for the detection of Human papillomavirus (HPV), DNA, reagents, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment).

All costs integrated into this contract must be calculated based on annual test volume and type. All supplies and equipment must be supplied and serviced through a single Contractor. All supplies and equipment, to include connections between equipment must be approved by the US Food and Drug Administration (FDA) by the solicitation close date.

All equipment displays and supporting literature must be in the English language. Contractor shall include delivery, installation, all calibrators/standards, reagents/reagent packs, and quality control materials necessary to perform the specified assays, initial Method Validations per CLIA/NCCLS/DPALS QM guidelines and analyzer removal at the termination of the contract.

All costs will be calculated on a Cost per Test based on the number of patients listed for each Mandatory Test. Costs shall be amortized over the total number of tests described in this SOO and factored into the Cost per Test.

Consumable items and reagents for testing will also be required. Specific details will be provided in the formal solicitation expected to be posted on/are about 04 Jun 2018.

A summary of the solicitation is as follows:

1. Instruments/Equipment and Reagents/Consumables. Instruments/Equipment.
Testing system shall include testing for the following: HPV High Risk pool plus HPV 16 & 18 Genotype simultaneously eliminating the need to re-run a sample; as well as a traditional High Risk pool (14 HR Genotypes) with no grey zone or indeterminate results.

2. Reagents/Consumables.
The contractor shall have FDA approved reagents/consumables that shall meet the requirements of the Reference laboratory mission, workload, and test menu.

3. Service and Maintenance
The Contractor shall provide direct customer service and support, 24 hours/7 days a week, to include hotline telephone service (provided in English) and on-call emergency repair, to assist operators in correcting equipment problems.  

4. Training
The Contractor must provide initial on-site operator training to all technicians assigned to the Government site normally assigned to perform the associated testing prior to implementation of the analyzer for patient testing. In addition, the Contractor must provide training for two (2) primary (key) operators, per major analyzer and automated system at the Contractor's training site in accordance with the Joint Travel Regulations prior to implementation of the analyzer.

5. Delivery and Installation
All systems must be delivered to the appropriate location indicated within 90 calendar days after contract award.

Point of contact is Ms. Gerri Hernandez, Contract Specialist, at (210) 221-3252, geraldine.i.hernandez.civ@mail.mil.

Once the solicitation is posted, interested parties are urged to visit the FedBizOpps Websites frequently for any updates/amendments to any and all documents.