Blood Gas Analyzers

Blood Gas Analyzers, Dayton VA Medical Center

RFQ #36C25020Q0048

General.

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested and a written solicitation document will not be issued.

This solicitation is issued as a Request for Quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2020-01, effective November 9, 2019. This solicitation is Full and Open Competition. The associated North American Industrial Classification system (NAICS) Code for this procurement is 334516, with a Small Business Size Standard of 1,000 Employees. The FSC/PSC is 6630.

Requirement.

The Dayton Veterans Affairs Medical Center (DAY VAMC) is seeking to establish a firm-fixed price, Cost per Reportable Rate (CPRR) Base, Plus Four (4) One (1) Year Option periods agreement for automated blood gas testing. The contractor shall provide two (2) identical analyzers capable of performing fully automated blood gas testing to include:

Ionized Calcium

pH

PCO2

PO2

Bicarbonate

Base Excess

TCO2

Total Hemoglobin

Carboxyhemoglobin

Methemoglobin

Oxygen Content (Vol%)

Hemoglobin Oxygen Saturation

Percent Oxyhemoglobin

All interested companies shall provide quotations for the following:

Description

Tests/Year

Blood gas testing to include pH, PCO2, PO2, Bicarbonate, TCO2, base excess, Total hemoglobin, percent oxyhemoglobin, carboxyhemoglobin, methemoglobin, hemoglobin oxygen saturation rate and oxygen content

1400

Ionized Calcium

350

Methemoglobin

15

Carboxyhemoglobin

40

Reagents and supplies based on 1,805 tests per year and quality control-based College of American Pathology, Clinical Laboratory Improvement Act (CLIA), and the Joint Commission requirements at a minimum.

Scope.

In the measurement of blood gas, co-oximetry, and ionized calcium, the instrument shall

meet the performance characteristics for accuracy and precision as defined by the 1988 CLIA and the Clinical and Laboratory Standards Institute (CLSI). The analyzers must also be approved by the Food and Drug Administration (FDA) for diagnostic utilization. The objectives of this acquisition are to have two (2) identical blood gas instruments that will continue to give high quality results in the least amount of time, adhering to the performance measure of turnaround time of 30 minutes or less , and that there be no delays in reporting around the clock. Because the results of this test need to be available to the provider within 30 minutes or less of receipt in the laboratory, it is especially important that the instrument running this test provides fast blood gas results with accuracy and precision. To avoid possible delays, both analyzers must be ready to process specimens 24 hours a day.

Specific Tasks.

In addition to having secured approval by the FDA, the instruments shall have the following:

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.

Ionized Calcium

pH

PCO2

PO2

Bicarbonate

Base Excess

TCO2

Total Hemoglobin

Carboxyhemoglobin

Methemoglobin

Oxygen Content (Vol%)

Hemoglobin Oxygen Saturation

Percent Oxyhemoglobin

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.

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 (