Blood Culture Analyzer

Added: Mar 12, 2018 1:01 pm The Department of Veterans Affairs, Louis Stokes VA Medical Center intends to solicit and negotiate with only one source under authority 6.302-1, Only One Responsible source and no other supplies or services will satisfy agency requirements. The VA intends to solicit and negotiate with Biomatrix Vitek Inc., for the period of performance June 2018. This notice of intent is not a request for competitive proposals. However, any responsible source who believes it is capable of meeting the requirement may submit a quotation, which shall be considered by the agency, only if received by the closing date of this notice. The solicitation number is 36C25018Q0395. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-97. The associated NAICS code is 334516, Analytical Laboratory Instrument Manufacturing. The Small Business Standard is 1,000 employees. The requirement is for acquisition of:



Description/Part Number*

Qty

BacT/Alert System- Virtuo (432 cells)

1

Myla

1

 

 



Items are to be delivered to the Louis Stokes VA Medical Center, 10701 East Boulevard, Cleveland OH 44106

Estimated Delivery Date: 06/01/2018

F.O.B.: Destination

This announcement constitutes the only solicitation; a formal, written solicitation will not be issued. PAPER COPIES OF THIS SOLICITATION WILL NOT BE AVAILABLE. This solicitation documents and incorporates provisions and clauses in effect through FAC 2005-97. It is the responsibility of the contractor to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at these addresses: https://www.acquisition.gov/Far/. The selected Offeror shall comply with the following commercial item terms and conditions, which are incorporated herein by reference: FAR 52.212-1, Instructions to Offerors -Commercial Items; FAR 52.212-2, Evaluation-Commercial Items; FAR 52.212-3, Offeror Representations and Certifications-Commercial Items - the selected offeror shall submit a completed copy of the listed representations and certifications or confirm that the annual representations and certifications was completed electronically via the SAM website accessed through http://www.acquisition.gov;



FAR 52.212-4, Contract Terms and Conditions-Commercial Items; 52.203-17, 52.204-4, 52.216-1 and 52.232-40



FAR 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items, paragraph (a) and the following clauses in paragraph (b): 52.203-6, 52.204-10, 52.209-6, 52.211-6, 52.219-6, 52.219-8, 52.219-14, 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.222-50, 52.223-18, 52.225-1, 52.225-13, 52.232-33 and 52.233-2. The full text of the referenced FAR clauses may be accessed electronically at https://www.acquisition.gov/far/.





Evaluation: will be made using the procedures under FAR 13. Lowest Priced Technically Acceptable





The following VAAR Clauses apply



852.203-70 Commercial Advertising



852.211-70 Service Data Manuals



852.232-72 Electronic submission of payment requests



852.246-70 Guarantee (at least one year)



852.246-71 Inspection

852.211-73 Brand Name or Equal



The Following VAAR Provisions apply



852.211-72 Technical Industry Standards



852.233-70 Protest Content/Alternative Dispute Resolution

852.233-71 Alternate protest procedure

852.252-70 Solicitation provision or clauses incorporated by reference



Quotes are to be emailed to Percy Johnson at percy.johnson2@va.gov, no later than 19 March 2018 1:00 p.m. EST



ITEM INFORMATION

ITEM NUMBER

DESCRIPTION OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

0001

BacT/Alert System Virtuo (432 Cells)

LOCAL STOCK NUMBER: Virtuo



1.00

EA







Funding/Req. Number: 1





0002

Myla

LOCAL STOCK NUMBER: Myla



1.00

EA







Funding/Req. Number: 1









1. Contract Title. BLOOD CULTURE ANALYZER

2. Task.

To meet the needs of P&LMS, the equipment must meet the following salient characteristics:

Operational Features:

Instrument must be FDA approved for clinical use.

The system shall provide self-contained, continuous, computerized, automated monitoring of blood culture bottles with immediate, active (e.g. audible alarm) notification of microorganism growth based upon preprogrammed criteria and notification of termination of maximum programmed incubation period when no microorganism growth is detected.

The system shall allow for operator extension of programmed incubation times, while testing is in progress, without interruption of automatic continuous monitoring.

A varied selection of blood culture bottle configurations (low volume samples; antimicrobial agent removal resins) and formulations capable of maximizing growth potential of various microorganisms (e.g. aerobic and anaerobic bacteria, and fungi) shall be available.

Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the lab testing equipment must be minimal and require a minimum amount of handling.

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

The accuracy of the barcode reading must have less than a 1% failure rate.

Lab testing equipment must be able to support multiple barcode formats that may be enabled concurrently.

Lab testing equipment must accept, at a minimum, 10 characters in specimen identifier that is alphanumeric

An operational system that is automated and provides continuous unattended testing throughout the day for a minimum of five days.

The system will be capable of processing inoculated bottles that have been incubated off line at room temperature for up to 24 hours

Minimal daily and periodic maintenance.

The reading chambers must be modular in nature allowing for the isolation of a given problem without having to shut the entire system down.

Analyzer utilizes windows operating software or other VA approved operating system.



Technical Features:

The system shall support bar-code recognition of inoculated bottles for tracking of bottles at entry into the system and throughout incubation until such time as the incubation has finalized as positive or negative for growth.

Instrument must have automated loading and unloading capabilities allowing for off shift bottle loading by non-specialized staff

The capability to record, store and print the following information:

blood culture bottle location,

length of incubation, time to detection,

growth curve analysis of positive vials,

required quality control and instrument maintenance information,

patient demographic information and specimen results,

time of positive detection,

time of bottle removal,

the fill volume of the blood culture bottle,

detailed epidemiology reports

Shall be capable of maintaining all data and if interfaced, retransmit data for up to 24 hours in the event of normal electrical power interruptions via battery backup.

Shall have a built-in quality control program to regularly monitor performance of vital components.

Shall possess capability to backup all data to a secondary external storage format (e.g. compact disk).

Shall have sufficient memory to store patient information and test results for 10,000 records with downloading capability to an external medium for long term storage of patient records and other information.

System can provide a daily report of both Negative and Positive bottles

Blood Culture Bottles:

Transparent Plastic Bottles are desirable for safety

Shall be easily distinguished (e.g. color coded) for utility or intended purpose

Shall be approved for culture of normally sterile body fluids other than blood and platelets.

Shall be bar-coded with unique identifiers for loading and system monitoring.

Shall be formulated as not to require venting prior to incubation of aerobic bottles.

Shall have expiration date clearly marked. The minimum acceptable expiration date will be no less than 9 months

The vendor must maintain and supply records for each lot of media produced and received by the laboratory, such as a certificate of conformance , which indicates that the QC was performed and meets the CLSI/NCCLS standard and checklist requirements listed in Standard M22-A3, Quality Control for Commercially Prepared Microbiological Culture Media

The media and incubation conditions shall have been validated for the detection and recovery of fastidious bacteria (such as N. meningitidis, S. pneumoniae, H. influenzae) mycobacteria, fungi and yeast





Hardware Features:

A total lab testing equipment footprint that shall not exceed 2.5 x 5

An on-board monitor/screen that is easily readable

A printer that has the capability of printing a patient report with patient demographic information that includes minimally the full patient s name, Full Social Security Number and accession or unique identifier number (UID).

An uninterruptible power supply with line conditioner for each instrument provided



Method Validation Requirements:



The Contractor shall assist the site in the performance of all comparison and validation studies to include providing any materials and reagents needed for such correlation at no cost to the Government. The Contractor shall perform all statistical analysis, as applicable, and report data in an organized, clearly comprehensible format. This process shall be consistent with current CLSI Standards and related documents, CAP standards, and Federal Regulations and service chief s requirements.



Support Features:

Training. The Contractor shall provide an instrument training program that is coordinated with and timely to the lab testing equipment installation for two personnel. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Scheduling of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant

The Contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices



Interface Requirements:

System must be interfaceable with VHA computer systems. In addition, software must be able to communicate with the VITEK II software.

The Contractor shall provide any and all necessary software support for insuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself.







The C&A requirements do not apply, and that a Security Accreditation Package is not required



Delivery: The equipment must be delivered to the Louis Stokes Cleveland VA Medical Center no later than June 1, 2018.