36C26124Q0802.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 21 VA Southern Nevada Healthcare System 6900 N. Pecos Road, Building 6 North Las Vegas NV 89086

POINT OF CONTACT*

Contracting Officer Richard Leistiko richard.leistiko@va.gov

PLACE OF PERFORMANCE

North Las Vegas VAMC

6900 N Pecos Rd

North Las Vegas NV

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

LEFT BLANK INTENTIONALLY

THIS SOURCES SOUGHT IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION.

THE SUBMISSION OF PRICING, CAPABILITIES FOR PLANNING PURPOSES, AND OTHER MARKET INFORMATION IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS SOURCES SOUGHT IN ACCORDANCE WITH (IAW) FAR 15.201(e).

No solicitation document is available at this time; this notice is to acquire information only.

PLEASE PROVIDE ALL RESPONSE TO THE CONTRACT SPECIALIST NO LATER THAN CLOSE OF BUSINESS 5 JULY 2024

52.215-3 -- Request for Information or Solicitation for Planning Purposes (Oct 1997)

(a) The Government does not intend to award a contract on the basis of this solicitation or to otherwise pay for the information solicited except as an allowable cost under other contracts as provided in subsection 31.205-18, Bid and proposal costs, of the Federal Acquisition Regulation.

(b) Although proposal and offeror are used in this Request for Information, your response will be treated as information only. It shall not be used as a proposal.

(c) This Request for Information is issued for the purpose of conducting market research to identify vendors that are capable and qualified to provide laboratory testing equipment.

If your firm is a Service-Disabled Veteran Owned or Veteran Owned Small Business, you must be CERTIFIED in VetCert (see internet site: https://veterans.certify.sba.gov/).

Mark your responses as “Proprietary Information” if the information is considered business sensitive.

Prospective Contractors are reminded that in accordance with FAR Subpart 4.11 they shall be registered in the System for Award Management (SAM) database and shall complete electronic annual representations and certifications in SAM prior to award of a contract. SAM is located at https://sam.gov/content/home and consolidated the capabilities of CCR/FedReg, ORCA, and EPLS. There is NO cost to use SAM.

The intended contract period is One (1) Base Year plus Four (4) Option Years.

Anticipated North American Industry Classification System (NAICS) code is 334516 - Analytical Laboratory Instrument Manufacturing – small business size standard 1000 employees.

Responses to this notice must include the following information:

1. Company Name:

2. Company Address:

3. Company DUNS:

4. Company NAICS Code(s):

5. Point of Contact Name:

6. Point of Contact Phone Number:

7. Point of Contact Email Address:

8. Company Website (if available):

9. Business Size/Type: (Service Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB) only)

10. If your company has worked with the VA or any other Federal Government agency

11. A description of your company’s experience with replacing Operating Room lights.

12. Place of manufacture, country, for the requested items to show compliance with the Buy American Act.

13. Original Equipment Manufacturer if not your organization

Any questions should be addressed to the Contract Specialist, in writing, at the email address provided. This is a request for information only, answers to questions will not be posted. If your organization has the capability to provide these items and is interested, please respond to Richard Leistiko, Contract Specialist, Network 21 Contracting Office (NCO21), via e-mail at richard.leistiko@va.gov.

REQUIREMENTS FOR CPT BLOOD BANK INSTRUMENTS

PATHOLOGY AND LABORATORY MEDICINE SERVICE

Blood Bank Instrumentation STATEMENT OF WORK (SOW) Purpose:

The purpose of this contract is to procure an Echo Lumena Blood Bank System (“Echo System”) via Purchase Contract for VAMC Las Vegas, Nevada. Contractor will provide, of all equipment supplied as part of this contract. The instrument(s) must be cleared by FDA for patient and donor blood bank testing. Reagents will be purchased at the quantities quoted per the test volumes supplied within this SOW.

1. PERIOD OF PERFORMANCE:

One Base year with 4 one-year option periods.

2. PLACE OF PERFORMANCE:

6900 N. Pecos Rd Las Vegas, NV

3. DAYS AND HOURS OF OPERATION:

Monday- Sunday, 24 hours a day including federal holidays.

4. EQUIPMENT DESCRIPTION:

The Contractor shall provide (1) Echo Lumena Blood Bank System (“Echo System”) and will include complete training for personnel, repair/replacement service parts vendor required preventive maintenance.

The instrument must perform the following test menu:

Immucor offers Capture Solid Phase technology to perform all listed tests. This technology is widely accepted and proven through many scientific papers to have superior sensitivity and specificity versus gel technology ABO/Rh

DAT

Crossmatch Donor Unit Retypes Antibody Screen Antibody ID The instrument must be capable of:

The instrument shall have random access. The instrument must use Capture Test Strips that has an out date of 3 months and are stored at room temperature. In addition to automated testing, reagents would also be required for manual tube testing. All automated reagents on our Echo Lumena System can be used for manual testing, therefore improving inventory management and maximizing cost efficiency.

Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority)

Immucor is the only FDA approved vendor who can provide Automated Blood Bank analyzer that uses Capture Solid Phase, Immucor’s proprietary technology.

The contract must provide the following services

· Contractor will provide all parts, labor, supplies and equipment needed to service the instrument when is in down time. Subject to Immucor’s Service and Support Plan attached.

· All service, repair and maintenance (other than user-performed maintenance) will be performed by the contractor with no additional expense to the government (VA). Subject to Immucor’s Service and Support Plan. Immucor offers a unique service plan that allows the operator to self-service many aspects of the instrument.

· Business hours of service provided for the length of the contract.

· Contractor will ensure that scheduled maintenance is performed and scheduled within the time frame specified by the cGMP of the instrument.

· Contractor will ensure that maintenance is scheduled with customers in advance of arrival on site.

· Service personnel must be trained and approved by the contracted vendor as required by the Manufacturer’s guidelines.

· Instrument validation must be provided by the vendor.

· Training must be provided by vendor, and expenses for the training must be included.

· Instrument must meet all requirements as noted below:

· Standard Operating Procedures must be provided by the vendor.

· Instrument correlation must be provided by the vendor.

Required system features

· Must be able to perform quality control, interpret quality control and document all lot numbers and expiration dates of the reagents.

· Instrument must save reaction strips or photographic evidence of reaction for up to 72 hours for review by supervisor when test is run during off hours.

· The system must use a maximum amount of two liters of solutions during daily processing (based on test volume noted).

· Instruments must be FDA approved for Immunohematology testing of both donors and patients.

· Each system must fit into a foot print of 64” with” x 40” depth with weight less than 200 lbs. due to counter size and capacity (unless manufacturer provided counter fits area assigned to testing).

· The system should have random access, batch processing, continuous sample loading, and Stat capabilities.

· Must accept loading of at least 30 unit confirmations at the time.

· Use of donor blood unit segment for confirmation and crossmatching without the need of spinning for packing the red cells.

· Bar code reader able to read ISBT, Codabar, and Code 39.

· Must have ability to detect clots in patient samples and donor segments.

· Must perform complete test menu: ABO/Rh patient, ABO Donor, Rh Donor, Antibody Screen, Antibody ID, Direct antiglobulin test detecting IgG and Complement, Immediate Spin XM and Extended XM. All of the enclosed test must have interpretation and actual recording of results.

· Power supply of 100-120 V

· Must accommodate all common test tube samples (from 2ml to 8.5 ml of collected sample)

· Must be able to use plasma (CPD, CPDA-1, Na Citrate, K2 EDTA) or serum.

· Turnaround Time of 45 minutes or less for Type and Screen and crossmatch.

· The manufacturer must supply instrument maintenance of the instrument as required by FDA.

· Contractor must provide all parts, labor, supplies and equipment needed for service of the instrument.

· System must have a system for interphase with Department of Veterans Affairs Information System

Training

· Contractor to provide off-site training classes (to include operation, user-performed maintenance, troubleshooting, and operation of middleware) for a minimum of two (2) VA operators at no additional cost to the VA. Training will be provided by individual(s) qualified to give instruction in the proper operation of the instrument(s). Additional vendor-performed on-site training of all users must occur prior to start of testing. Contractor to provide training plan with proposal.

· Immucor’s provides onsite training of VA operators (e.g. Blood Bank Supervisor, Shift Supervisor, and Lead MT/Technical Specialist).

· Immucor will provide three (3) days of training (up to eight (8) hours a day) to Customer operators (at the same time) at Customer’s facility during the week of Immucor Echo System installation. Training is intended to enable Customer to operate the Echo System, and perform the ordinary maintenance and repair of the Echo System using the Echo Kit and Customer Changeable Parts listed in the Support and Service Plan (as defined below).

Installation/Maintenance/Service/Project Management

· Vendor will provide a project manager who will assure the installation is coordinated with VA and vendor staff to assure that all aspects of installation are met to achieve go live date to be determined at the award.

· System space, plumbing, and electrical requirements must not require major modifications to existing space

· Installation of analyzer will be performed by contractor. Contractor will provide all parts, labor, supplies and equipment to install the analyzer and water system. Contractor will complete analyzer function checks during installation to ensure proper operation.

· Installation processes must include all validation studies (performed by contractor's technical specialist) and include the following: calibration, correlations, carryover, validation of all system features, and any other testing deemed necessary to validate the analyzer(s). All materials required to perform these studies will be provided by the manufacturer at no additional cost to the Pathology and Laboratory Medicine Service or the North Las Vegas VA Medical Center.

· The vendor will provide hard copies and CDs of System Service and Operational and Procedure Manuals, MSDS, and IFUs (Instructions for Use) of all configured assays.

· Validation studies are to be printed, organized in a binder, and presented to the VA for approval no less than two weeks prior to the system(s) go live date.

· All service, repair and maintenance (other than user-performed maintenance) will be performed by the contractor at no expense to the government (VA).

· Vendor to provide hazardous waste determination with proposal. The Hazardous Waste Determination is a procedure used to determine whether the by-products (liquid and solid waste) of an analytical process are characterized as a hazardous waste. This information to be provided based on the estimated workload as noted above.

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

Sources Sought Notice