Specs-SOW SS-SOL.pdf

Specifications for Brand Name Only purchase:

Piccolo Xpress is a compact, portable clinical chemistry system designed for on-site patient testing. Roughly the size of a shoebox, health care providers can use the easy-to-follow color touch screen commands to perform routine multi-chemistry panels. 0.1cc of whole blood, serum or plasma is added directly to the patented 8-cm diameter single use plastic disc containing the liquid diluent and dry reagents. The disc is placed in the analyzer drawer where centrifugal and capillary forces are used to mix the reagents and sample in the disc. Piccolo Xpress monitors the reagent reactions simultaneously using nine wavelengths, calculates the results from the absorbance of data and reports the results. The Piccolo Xpress self-calibrates with each run, and the on-board continuous intelligent Quality Control (iQCT) monitors the analyzer, reagent reactions and sample to ensure chemistry and instrument integrity. This ensures you the highest quality and accuracy in results. Results are ready in approximately 12 minutes with a “hard copy” report suitable for the patient file or transferred to a computer, printer or an LIS/EMR. This enables you to rapidly obtain critical diagnostic information from the point of care. The easy-to-use, low maintenance system requires no special training to operate. The Piccolo Xpress only takes three steps.

Piccolo Xpress delivers routine multi-chemistry and electrolyte test results quickly and easily in virtually any treatment setting,

• A fully automated system with walk away operation

• Uses a small sample size (0.1cc of whole blood, serum or plasma)

• No sample pre-treatment is needed

• Results are available in approximately 12 minutes.

• The built in intelligent Quality Control meets CLIA and NCCLS requirements for daily control testing

• The Piccolo Xpress delivers up to 24 individual tests including CLIA-waived lipids, liver enzymes and glucose monitoring

• Results are provided in a “hard copy” self-adhesive report or can be quickly transferred to a printer, computer or data management system, enabling physicians to rapidly obtain critical diagnostic information at the point-of-care

Compact and portable, the Piccolo Xpress is easy to incorporate into your clinical setting, yet provides precision and accuracy comparable to larger, more expensive laboratory analyzers.

• Small footprint measures 32.4 cm (12.75 in.) x 15.2 cm (6 in.) x 20.3 cm (8 in.)

• Portable and lightweight with carrying handle only weighs 11.2 pounds

• The advanced technology uses centrifugal and capillary forces to mix diluent, reagents and sample in a self-contained, disposable disc lessening opportunities for procedural errors

• On-board intelligent Quality Control system performs continuous QC checks during the complete analytical process to ensure accurate results

• Bar coded self-contained reagent discs are self-calibrating and monitors panel information

• Multi- analyte panel results include alpha-numeric patient information, analyte concentrations, reference ranges, sample integrity indices and QC performance

• Operator security capabilities limit non-user entry

• Peer reviewed studies support performance

• Bidirectional communication USB ports transmit data to external peripherals.

• Stores up to 5000 patient and control results on-board

The Piccolo Xpress procedure is quick and easy to perform.

• No special operating skills are needed to run Piccolo Xpress

• Easy to use color touch screen guides the operator through the process

• Flexible alpha – numeric data entry options and analyzer settings

• Self-contained, disposable reagent discs are easy to handle

• Every reagent disc automatically self-calibrates

• Integrated intelligent Quality Control (iQC) checks performance and accuracy

• Requires very little maintenance

• Operates from line or 15-volt battery power

• Direct compatibility supported with USB peripherals including bar code readers, keyboards, personal computers and printers.

• CD Software makes testing upgrades easy

SCOPE OF WORK FOR

Acquisition of new Abbott Piccolo Xpress analyzer for the

Wagner Health Center

PURPOSE:

The purpose of this contract is for the purchase of a new Abbott Piccolo Xpress blood analyzer.

SCOPE OF WORK:

Contractor shall provide to the Great Plains Area Indian Health Service, hereafter referred to as the Government, with the equipment and supplies described in this statement of work for the period specified on the issued purchase order and any modifications or amendments.

The contractor shall provide all resources necessary to accomplish the tasks and deliverables described in this Statement of Work (SOW).

The contractor shall provide confirmation that they are an authorized distributor of Abbott Piccolo Xpress equipment if they are not the Original Equipment Manufacturer (OEM). Contractor shall arrange for shipping the equipment and supplies to the Wagner Health Center loading dock.

Physical Address for delivery:

Wagner Indian Health Service Health Center Attn: Lab Manager 111 Washington Ave NW Wagner, SD 57380 605-384-3621 Wanda.dally@ihs.gov

It will be the responsibility of the Service Unit to identify an operational location which will meet the installation and operational requirements of the equipment. Any modification/ renovation to an identified space needed to meet the operational requirements for the equipment will be the responsibility of the Service Unit.

Specification: Fully automated system requires no special operating skills. Estimated 12 minutes run time, 0.1cc whole blood, serum or plasma, Delivers multi-analyte panels including CLIA-waived lipids, liver enzymes and glucose monitoring, Self-calibrates with every test run, Built-in iQC™ eliminates daily liquid control testing, Walk-away operation, Full-color touch screen with intuitive user interface, Results are printed on a self-adhesive hard copy.

The contractor shall provide the following items:

ABO07P0201 QTY 5 PK TESTS, REAGENT: GENERAL CHEMISTRY 6 REAGENT TEST

ABO07P0407CS QTY 5 PK PAPER ROLLS, PICCOLO XPRESS: THERMAL RESULTS ADHESIVE-BACKED PAPER FOR

ABAXIS PICCOLO XPRESS ANALYZER, 6 ROLLS/PACK.

ABO07P0416 QTY 5 PIPET TIPS, PICCOLO: DISPOSABLE PICCOLO PIPET TIPS, RACK OF 96

ABO07P0550 QTY 1 ANALYZERS: PICCOLO XPRESS CHEMISTRY ANALYZER WITH 3 YEAR WARRANTY

ABO07P0208 QTY 5 TESTS, REAGENT: COMPLETE METABOLIC PANEL REAGENT TEST

USER / OPERATOR MANUAL FOR PICCOLO EXPRESS EQUIPMENT

Performance Period:

Delivery of equipment and supplies to be 30 days after award.

QUALITY CONTROL:

The Government reserves the right to perform a validation/incoming performance & safety inspection.

Contractor is responsible for providing all equipment / supplies specified in this SOW. The contractor is to provide a 3-year warranty of the Abbott Piccolo Xpress analyzer.

BASIS OF PAYMENT:

mailto:Wanda.dally@ihs.gov

Payment will be made upon receipt of a complete and accurate invoice, and successful completion of an acceptance inspection in accordance with the Prompt Payment Act. Invoices shall be submitted with all information and supporting documentation. A complete and accurate invoice is substantially correct in that all aspects of the required information are clearly evident on the invoice. If items such as invoice number, date, dates of service, contract/purchase order number, etc., are not on the invoice, it will be returned to the Contractor for resubmission. The Prompt Payment Act Clause will be provided by the Contracting Officer at the time of award and will further clarify the requirements. Finance charges for late payment of charges due to problems not of the Contractor’s making shall be paid according to the regulations and amount determined by the Great Plains Area Indian Health Service Financial Management Branch. If the Government fails to pay an amount when properly due, the Contractor has the option of suspending all services provided by this contract after providing a detailed explanation to the Contracting Officer. The Contracting Officer is responsible for assuring that direct patient care is not compromised by frivolous or unlawful suspension of services. Disputes will be handled according to the Disputes Clause and shall not violate any rule or regulation or law.

LIABILITY:

In no event shall the Government release the Contractor from the liability arising from acts of omission, improper repair, negligence, or deliberate or non-deliberate acts that jeopardize the health and safety of patients and/or Government employees.

CONTRACTOR’S TERMS & CONDITIONS:

The contractor’s terms and conditions shall be incorporated into the contract by reference. Where conflicts arise the Federal Acquisition Regulations, and other Federal Regulations, Laws and Rules shall take precedence.

AUTHORITY:

No person other than the Contracting Officer has authority to bind the Government with respect to this contract.

No action or omission of any government employee or representative other than the Contracting Officer shall increase or decrease the scope of this contract or shall otherwise modify the terms and conditions of this contract.

In no event shall any of the following be effective or binding on the Government or imputed to the Contracting Officer with respect to this contract:

1. An understanding or agreement between the Contractor and anyone other than the Contracting Officer;

2. A purported modification or change order issued by anyone other than the Contracting Officer;

3. A promise by anyone other than the Contracting Officer to provide additional funding or make payments; or

4. An order, direction, consent, or permission from anyone other than the Contracting Officer to:

4.1 Incur costs in excess of a specified estimated cost, allotment of funds, or other ceiling; or

4.2 Expend hours in excess of a specified level of effort.