6515--ISTAT SYSTEM Blanket Purchase Agreement (BPA) Base 4 year

Combined Synopsis/Solicitation Notice

Combined Synopsis/Solicitation Notice

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Combined Synopsis/Solicitation Notice

*= Required Field

Combined Synopsis/Solicitation Notice

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(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; offers are being requested and a written solicitation will not be issued.

(ii) The solicitation number 36C26225Q0241 is issued as a Request for Quotation (RFQ).

(iii) The provisions and clauses in this document are in effect through the Federal Acquisition Circular.

(iv) This solicitation is UNRESTRICTED using NAICS Code 3345140 having a size standard of 1,250 employees.

Description/Statement of Work

The Department of Veterans Affairs (VA), VISN 22 Network Contracting Office, is seeking to procure an ISTAT System that meets the following Statement of Work and specifications for the VA San Diego Healthcare System.

This contract will be a Blanket Purchase Agreement (BPA) with a Base + 4 option years (5 years).

**Abbott Laboratories**

CONTRACT LINE ITEM & DESCRIPTION

Quantity

EG7+ iSTAT CARTRIDGE / 03P76-25

9000

CHEM8+ iSTAT CARTRIDGE / 09P31-26

4000

ACTk iSTAT CARTRIDGE / 03P87-25

2000

cTnl iSTAT CARTRIDGE / 03P90-25

2000

Statement of Work

IStat Point of Care

1. SCOPE:

1.1 Contractor shall provide all equipment, reagents, standards, controls and any other item required for the proper operation of its contractor owned analyzers and peripherals necessary for the generation of a combination of the following test results: blood gas (arterial, venous, mixed venous), chemistry testing (glucose, creatinine, Sodium, Potassium, chloride, BUN, ionized calcium), Hemoglobin/hematocrit, Troponin, Kaolin Activated Clotting Time cost per test (CPT) services on behalf of the VA San Diego Health Care System (VAHCS), 3155 La Jolla Village Dr, San Diego, CA, 92161. Services shall be required for a base one year period with four one-year options for renewal.

1.2 Analyzers are specialized instruments for the testing of specific parameters of whole blood for therapeutic monitoring and routine screening. The analyzer(s) offered by the contractor shall be portable, bedside units for use primarily in the clinical areas of the hospital. Services shall be provided to the VA San Diego Pathology & Laboratory Medicine Service (P&LMS) in San Diego CA, 92161.

2. DEFINITION/ACRONYMS:

1. Cost Per Test (CPT): The loaded cost charged to the VA by the contractor each time the equipment is used by the VA. The loaded cost shall be all inclusive and incorporate, as a minimum, the following:

(a) Equipment use

(b) All reagents, standards, controls, supplies, parts, accessories and any other item required for the proper operation of the contractor s equipment

(c) Any software or program necessary for data management

(d) Any middleware necessary for the generation and reporting of a test result in VISTA. This middleware must be capable of supporting other instrumentation in the resulting of tests at the Point of Care (e.g. glucometers, blood gas coox analyzers, etc.)

(e) All necessary maintenance to keep the equipment in good operation condition (this element includes both preventive maintenance and emergency repairs)

(f) Training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge.

2. San Diego Health Care VA System

3. CAP - College of America Pathologists

4. JC Joint Commission

5. QC Quality Control

3. GENERAL REQUIREMENTS:

3.1 Offered models of clinical laboratory analyzers shall be capable of producing accurate and reproducible assays on blood by established in vitro diagnostic methods. Models shall provide accurate test assay results for sample specimens up to the manufacturer s defined maximum test per hour without excessive malfunctions, breakdowns, or service calls.

3.1.1 Offered equipment shall be current state-of-the-art equipment. Remanufactured and discontinued models will not be accepted.

3.1.2 The awarded contractor shall provide all upgrades to the equipment hardware and operating system software, at no additional cost to the Government. The contractor shall provide or include in the Cost per Test technical support for the software programs required for data management and interfacing results into VISTA. These enhancements shall be delivered and installed at each participating VISN 22 medical facility within 60 days of issuance to the commercial market.

3.1.3 The models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, current production shall mean that the clinical laboratory analyzer model is being manufactured as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

3.1.4 An operator s manual shall be furnished with each instrument supplied to VA and updates to the manual shall be provided in a timely manner.

3.1.5 Contractors offered analyzer shall conform to all facilities existing space constraints. The hand held portable point of care unit, capable of being used at the bedside, provided by the contractor shall fit within an approximate 12 X 12 X 12 space.

3.3 In the event that the consumables are found to be defective and unsuitable for use with the contractor s equipment, or the contractor has failed to comply with the requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of twenty-four hours after receipt of the verbal order for priority delivery from the Government activity. If either circumstance has occurred, the contractor shall deliver to all participating facilities in the most expeditious manner possible, without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the contractor s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they will be honored by the contractor until the arrival at the Government site of the monthly standing order/routine supplies delivery. Failure to reserve adequate inventory may result in default.

3.4 Inventory Control Reagents, Supplies and Disposable: The contractor shall maintain on Government provided space a continuously stocked inventory of reagents, standards, controls, supplies, and any other material required to properly perform tests on the offered equipment. These items shall be of the highest quality ensuring sensitivity, specificity and tested to assure precision and accuracy. The quality of the products shall be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission (TJC).

3.5 Maintenance and Repairs:

3.5.1 With the exception of the specific maintenance and repair requirements stated herein, which shall have precedence; preventive maintenance, emergency repair, maintenance credit for equipment malfunction, and replacement laboratory equipment shall be performed and provided in accordance with the terms, conditions, and provision of contactor s existing Federal Supply Service Contract for performance of CPT services as stated in Subsection III of the VA National Acquisition Center contract requirements Solicitation (RFP 797-FSS-03-0001).

3.5.2 Emergency repairs shall be performed after initial telephone notification that the equipment fails any parameters. The contractor shall provide the Government with a designated point of contact and telephone number and shall make arrangement to enable his maintenance representative to receive such notification.

3.5.3 The contractor shall repair or replace (replace defined as in place and functioning in the facility), at any/all locations specified in the Statement of Work, any malfunctioning equipment within forty eight (48) hours after receipt of initial telephone notification of a malfunction. Contractor shall provide maintenance coverage 24-hours per day, seven days per week including all Federal holidays for VA Health Care System in San Diego. Contractor shall provide technical support service to assist in troubleshooting 24-hours per day, seven days per week including Federal holidays.

3.5.4 In-addition to above the contractor shall furnish a malfunction incident report to the installation upon completion of each repair call. The report shall include, as a minimum, the following:

Date and time notified

Date and time of arrival

Serial number, type and model number(s) of equipment

Time spent for repair

Description of malfunction and repair, and

Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

3.5.5 During the term of the BPA, should the repair record of any individual piece of laboratory equipment reflect a downtime of 5% of greater of the normal working days in one calendar month, a determination will be made by the designated representative of the Government at the using facility to replace the initial laboratory equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer s instruction, shall be solely that of the contractor. Each instrument provided by the contractor shall maintain an uptime of 95% in each month of the term of the agreement.

3.5.6 Training: With the exception of the specific training requirements states herein, which shall have precedence; contractor shall provide training in accordance with the terms, conditions, and provisions of contractor s existing Federal Supply Service Contract for performance of CPT services as stated in Subsection IV of the VA National Acquisition Center contract V797P-7322A.

4. SPECIAL REQUIREMENTS: In addition to the general requirements for the Cost-Per-

Test requirements states above, the contractor shall meet the following special requirements:

4.1 The contractor s unit shall have software/middleware that is fully VISTA compatible, capable of simultaneous data transfer from the unit to the VISTA system (without upgrade or other software modification), and all hardware /software necessary to transfer data into patient files in VISTA shall be provided at no additional cost to VA.

4.2. System shall provide appropriate quality control analysis system and all components necessary to interface with VISTA.

4.3 Shall have auto quality control to meet CAP standards (1 level per 8 hour shift)

4.4 Provide QC lock out and operator lock out

4.5 QC shall be available in Levy Jennings format, or statistical reporting available

4.7 Shall have ability to run venous, mixed-venous and arterial samples for blood gases

4.8 Shall provide a two (2) to three (3) minutes turnaround time for samples on most tests

(Shall provide