36C25020Q0048-001.docx

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* = Required Field FedBizOpps Sources Sought Notice Rev. March 2010 Blood Gas Analyzers 45409-1337 36C25020Q0048 10-29-2019 N 334516 Department of Veterans Affairs Network Contracting Office 10 Governor’s Place Blvd. Suite 210 Kettering OH 45409-1337 Angie Carpenter angie.carpenter@va.gov Department of Veterans Affairs Dayton VA Medical Center 4100 West Third Street Dayton OH 45428-9000

USA

www.va.gov VA Homepage angie.carpenter@va.gov Procurement Point of Contact 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

1. 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 and weight of analyzers: less than 20 x 20 x 20 inches in size, 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 (<3.0%) on College of American Pathologist surveys

· In case of interface outage, the instrument must possess the ability to store and transmit patient data for at least 24 hours of instrument throughput

· The equipment must have the capability to store at least 500 patient sample results in an onboard or fully connected database for immediate recall

· Associated computer operating system must be Microsoft Windows 7-based or higher

· Operational noise level should not exceed 70 decibels

· Analyzers must automatically calibrate per CAP requirements with no operator involvement

· Software must possess automated commands to stop a run if calibration or QC fails

2. Training:

· The contractor shall provide key-operator training for 2 operators per analyzer. This shall include training on the operation of the system, data manipulation, and basic troubleshooting and repair. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant.

· Contractor will provide operational hands-on training for all other operators as needed for each shift.

· The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair.

· Contractor will provide telephone assistance 24 hours per day, 365 days per year.

· Contractor will provide on-site service Monday through Friday, 8:00 am to 5:00 pm (local time), excluding national holidays at no charge. However, if both analyzers are inoperable, then vender shall provide on-site service after hours, weekends, and/or holidays as needed at no charge. Contractor will provide support for analyzers through the life of the analyzers and the contract at no cost.

· Contractor will perform all required preventative maintenance at no charge to customer.

· Contractor must furnish a designated point of contact for placing orders.

· Billing will start the month following the start of patient testing.

· Contractor will provide quality control peer group submission at no charge.

· Contractor will provide both an electronic and hard copy of Operator’s Manual and Instructions for Use documents.

· Contractors are required to provide white-glove delivery, installation and removal of equipment at no additional charge.

The Department of Veterans Affairs, Network Contracting Office (NCO) 10, is conducting market research to determine if there are a sufficient number of businesses capable of performing the requirements to warrant full and open competition. The proposed solicitation is to furnish all materials, labor, equipment and transportation required to provide equipment to the DAY VAMC. Contractor shall also comply with any other federal, state, and local laws applicable to the industry.

Potential sources must demonstrate experience and knowledge of required services and capability to provide such services. Potential sources should submit:

· Point of Contact with email address and phone number;

· Business name and address;

· Business size pursuant to NAICS code 334516, (size standard 1,000 employees);

· Business size;

· Applicable business socio-economic category;

· GSA, NAC, TAC, or SAC contract number if applicable;

· Capability statement;

· Recent and relevant projects similar in nature;

· DUNS number;

· brochure of commodity requested; and

· OEM Authorized Distributor/Dealer/Reseller Letter

The contractor shall be an Original Equipment Manufacturer (OEM). If not the OEM, then an authorized OEM distributor, dealer, reseller letter for the proposed equipment/system, such that the provided OEM warranty and service are maintained and remain enforceable, must be provided with your response. All warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. The Contractor shall provide new items ONLY; no remanufactured or "gray market" items. All items must be covered by the manufacturer's warranty.

Proprietary/Competition Sensitive information (appropriately marked) will be protected from disclosure to the greatest extent practical, however it is preferred that respondents do not provide proprietary or otherwise restricted responses unless they are indicating proprietary technical characteristics.

Contractors are hereby notified that if a competitive solicitation is issued on the Federal Business Opportunities website http://www.fbo.gov at a later date, all interested parties must respond to that Solicitation announcement separately from any response to this SS announcement. This SS does not restrict the Government's acquisition approach on a future Solicitation.

No faxes, courier delivered, or telephone inquiries/submissions will be accepted. Responses should be submitted to Angie Carpenter, Contract Specialist, angie.carpenter@va.gov, by 4:00 p.m. EST, Tuesday, 29 October 2019. Enter “RFQ 36C25020Q0048| Blood Gas Analyzer” in the email subject line.