Blood Gas Analyzers

RFQ #36C25020Q0048, Blood Gas Analyzers, Dayton VA Medical Center

This is a Sources Sought (SS) Notice only; it is not a Solicitation (i.e. Request for Proposal, Request for Quotation, or Invitation for Bids.), not a solicitation announcement, and should not be considered as such. This SS is part of a Government market research effort to determine the scope of industry capabilities and interest and will be treated as information only. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responses to this SS are strictly voluntary and the Government will not pay respondents for information provided in response to this SS. Responses to this SS will not be returned and respondents will not be notified of the result of the review. Although responses to the questions posed by the Government would be most beneficial to this market research effort.

The purpose of this SS is to conduct Market Research to determine an acquisition strategy for the establishment of a base plus four (4) one (1) year option periods, Cost per Reportable contract for automated blood gas testing. The contractor shall provide two (2) identical analyzers capable of performing full automated blood gas testing to the Pathology and Laboratory Medicine Service, Dayton VA Medical Center, located in Dayton, Ohio. The instrumentation shall perform all analyses for the required tests with precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS).

Operational Features

The instrumentation shall have the following basic capabilities (required):

Shall performed the following Blood Gas Analytes/Parameters/Derived(calculated):

Analytes

Ionized Calcium

pH

PCO2

PO2

Bicarbonate

Base Excess

TCO2

Total Hemoglobin

Carboxyhemoglobin

Methemoglobin

Oxygen Content (Vol%)

Hemoglobin Oxygen Saturation

Percent Oxyhemoglobin

Size of analyzers: 20 x 20 x 20 inches or smaller and weigh no more than 50 lbs.

In addition to having secured approval by the Food and Drug Administration (FDA), the instruments shall have the following requirements:

Ability to monitor instrument performance

On Board reagent inventory system

No carryover between samples

Analyzer must be able to sample from any sample s primary tube (example: syringe, whole blood vacutainers, and serum separator tubes). Pouring off any sample or use of an adapter is unacceptable

The ability to run micro samples of less than 100 uL

Throughput: 45 seconds or less to results from sample introduction

The instruments must perform the following tests with the option to add testing or other new testing that becomes available in the future, if the need arises

The contactor is required to provide continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the instruments such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy.

Both analyzers must be up and running 24 hours per day.

All supplies and reagents shall have a shelf life of not less than 6 months.

Contractor shall provide quality control material that meets CAP and CMS requirements for blood gas testing and does not require an Individualized Quality Control Plan (IQCP).

Quality control must be on board and not require any other quality control other than what is loaded on the analyzer.

The instrument must possess a bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

Equipment must have barcode reader to scan reagents and patient samples, and must read barcode of each sample

Equipment must be able to support multiple barcode formats that may be enabled concurrently to include Code 128, Code 39, and codabar. Equipment must accept, at a minimum, 10 characters in specimen identifier that is alphanumeric

The equipment must have no requirements for sample pre-treatment

The instrument must be fully operable with no manual reagent preparation

The instrument must be able to maintain on board reagent stability sufficient to accommodate volume use

The equipment should require minimal maintenance. No daily maintenance and less than 5 minutes of hands on time for any additional maintenance

The instruments methodology must be proven by stringent analytical techniques as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). Instrument must have a history of acceptable coefficient of variation (