Cost-Per-Test Arrangement for Mycobacterial Equipment, Reagents/Consumables, plus Delivery, Installation, Training, and Repair/Maintenance Services for the Department of Pathology and Area Laboratory Services, Brooke Army Medical Center (BAMC).

The Medical Regional Contracting Office, West (MRCO-W) is issuing this Sources Sought Notice to find potential sources to provide a cost-per-test arrangement for equipment and reagents/consumables, plus delivery, installation, training, and repair/maintenance services, to perform incubation and recovery, of mycobacterial specimens for the Department of Pathology and Area Laboratory Services, Brooke Army Medical Center (BAMC) Department of Pathology and Area Laboratory Services Microbiology Laboratory, Fort Sam Houston, Texas. A base period of performance of twelve (12) months plus four (4) twelve (12) month option periods are contemplated.

THIS IS NOT A SOLICITATION ANNOUNCEMENT – This is a Sources Sought Notice and is issued solely for information and planning purposes – it does not constitute a Request for Quote (RFQ) or a promise to issue an RFQ in the future. Solicitations are not available at this time and requests for a solicitation will not receive a response. This notice does not constitute a commitment by the United States Government to contract for any supply or service whatsoever. All information submitted in response to this announcement is voluntary; the United States Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the United States Government. Not responding to this Sources Sought Notice does not preclude participation in any future RFQ, should one be issued. It is the responsibility of the potential offerors to monitor this site for additional information pertaining to this requirement.

The Government will use responses to this notice in formulating its acquisition strategy. If the Government does not receive sufficient information in response to this notice to verify the potential for competition exists, it is possible that a sole-source contract, supported by a Justification and Approval document, will be issued to support the Government's requirement. MRCO-W is seeking the following information (please answer paragraph below with your response):

1. Company name, UEI number, CAGE code, and point of contact information (including phone number and email address), and socio-economic category(ies) as related to NAICS 325413 (In-Vitro Diagnostic Substance Manufacturing), such as 8(a), HUBZone, Women-Owned, Service-Disabled Veteran-Owned, Small, or Other-than-Small.

2. Capability Statement (limited to ten pages), describing how your company meets the below objectives, providing additional proof (such as FDA approval) where appropriate:

3. Our customer, DPALS, Bacteriology Lab at the main hospital located at BAMC requires the following equipment, reagents, supplies, consumables, and services required:

Basic Requirements: The system must include automated culture instruments able to collectively analyze non-blood specimens for presence of mycobacterial and fungal pathogens and include test methods approved by the Food and Drug Administration (FDA). Instrument must fit into a foot print no larger than 40 inches x 40 inches and have a maximum height of 55 inches.

Test Menu and Special Requirements for Awarded Contractor: Vendor must meet, or improve, each Laboratory's existing turn-around times as a minimum, by any change in instrumentation. Vendor must be capable of supplying reagent and associated consumables for either manual testing or automated testing on a government-owned instrument for the following:

Enhanced recovery of mycobacterial pathogens from non-blood sources, including but not limited to sterile body fluids, respiratory specimens, and tissues.

•  Capable of taking fluorescence readings on an hourly basis, at minimum.
•  Must have an integrated incubation system with a temperature range of 30-40C with monitoring 
capabilities.
•  Instrument must have audible alarm to provide notification of positive specimens.
•  Media container must allow for re-digestion of patient specimens in the event of non- 
mycobacterial contamination.
•  Capable of holding a minimum of 500 patient specimens at a time
 

Analytical Systems:

a. Ability to manage testing workflow of hospital laboratory.

b. Integrated modules must only require one system control center (computer and screen) to simplify operations.
c. Instruments must have load on the fly capabilities for reagents, and specimens.

d. Calibration of instruments must be easy and of minimal frequency.

e. Instruments must plug into a standard 120V outlet and be provided with individually dedicated electrical cord.

f.  Instrument must have an integrated display or be able to connect to a manufacturer provided computer for locating and displaying specimens.

g. Ability to link to MHS Genesis (LIS) for direct reporting.
h. Analyzer must be able to scan barcodes and be compatible with 39 and 128 barcode types.

i.  Chosen analyzers must have minimal daily, weekly, and monthly maintenance downtime. Please provide total maintenance times, for daily, weekly and monthly maintenance. Please include any hands on, automated non-maintenance activities.

j.  Vendor to provide average number of service calls per year per analyzer, provide access to a 24/7 on-call support system, and perform preventive maintenance as required.
 

Reagents and Supplies:

1. Vendor must provide applicable testing media for required specimen types: mycobacteriology specimens from non-blood sources.

2. Provided reagent bottles must contain a fluorescent indictor compatible with automated culture instruments.

3. Reagent tubes for non-blood culture instruments must be an open system to allow for re-digestion of specimens contaminated with non-mycobacterial species.

4. When applicable, reagents must be available for specimen digestion, growth supplementation, and antibiotic inhibition of non-target organisms.

5.  Quality of Reagents, Supplies and Disposables: The contractor shall assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality product. The reagent quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission. In the event that the supplies are found to be defective and unsuitable for use with the contractor's equipment or the contractor has failed to comply with the requirements herein, the contractor is required to deliver the supplies within 24 hours of receipt of the verbal order.

6. Vendor must provide 5 years of FDA field action notifications.