SOW - Coag Strips - BPA RALS.doc

PT/INR WAIVED TESTING

STATEMENT OF WORK (SOW)

SCOPE

The VISN 2 VA Health Care System wishes to establish a base year plus 4 option year BPA to include WAIVED Prothrombin Time/International Normalized Ratio (PT/INR) testing. It is a point of care testing system for PT/INR that is a waived complexity with data management capability and connectivity compatible with VISTA. The acquisition will be on a cost per test agreement that will include, reagent strips, control material, Data Connectivity and remote access, annual license FEE to the RALS system. Vendor should be available for troubleshooting at any time during the agreement. The test system MUST have the following features: CLIA Waiver, Interface capability with VISTA, Results upload from meter directly into VISTA, Data Management capability to monitor system quality, patient results and test operator activity. Operator and quality control lockout capability, finger-stick blood sampling and top or side dosing of sample. Vendor will properly package all reagents, to include Material Safety Data Sheets (MSDSs).

GENERAL REQUIREMENTS

1) The vendor shall provide the most current chemistry and immunochemistry combined platforms available, including the ability to link multiple analyzers (i.e. robotics).

2) The vendor will provide the facility with Food and Drug Administration (FDA) approved analyzer/equipment, reagents, controls, calibration materials, disposables, and any consumable parts necessary for analyzing/testing.

3) Equipment shall have accurate capability of monitoring reagent usage and provide reagent inventory upon request, in real time.

4) The vendor shall provide/install any routine and special items required to operate/maintain the equipment/analyzer in optimal condition such as but not limited to: printers, water supply, drainage systems, UPS, and surge suppressors. Also, to include any engineering controls necessary to maintain proper operating temperature. Any items excluded by the vendor shall be delineated in their technical proposal. The cost of the excluded items shall be incorporated in the price proposal.’

5) The vendors will set-up a flexible monthly supply delivery schedule and have communication with the COR and Contracting Officer in specific instances of reagent/ consumables supply and demand.

6) This requirement is for a cost per test equipment with ONE BASE YEAR, plus 4 OPTION renewal years.

EQUIPMENT FUNCTIONALITY

1) The information system must have a comprehensive QC Program for all tests which includes at a minimum the following options:

· QC files may be edited or corrected for errors manually with/without password protection

· On-board quality control data storage and reporting capabilities

· The ability to view and print daily and monthly QC results

· The ability to view and print Levey Jennings graphs

· On-line documentation of out of range QC

2) Equipment shall be able to store and retransmit records (24 hours of maximal instrument throughput) in case of interface downtime.

3) Interfacing requirements to be provided by the vendor:

Brief Summary of VistA Functionality

VistA is a public domain system to the VA whose functionality includes:

· Management of patient information through a database,

· Acceptance of test ordering information,

· Transmittal of patient laboratory test results.

· Storage and retrieval of patient laboratory test results.

(VistA is very limited in its functionality to manage laboratory quality control, provide Levy-Jennings plots or administer an instrument maintenance program.)

4) Ability for remote diagnostic interfacing capability.

INSTALLATION AND VALIDATION

1) Vendor shall move instruments to final testing location upon completion of validation process.

2) Vendor shall provide the facility with all cross-over supplies and reagents needed at installation and during training of staff. Test counts for billing will begin after review/approval by the Laboratory staff of all correlation/linearity studies performed at installation.

3) The vendor shall provide at installation/set-up and when bringing new tests on-line, a technical support specialist who shall perform all validation studies including installation/set-up, correlation studies (evaluation/comparison data sufficient to satisfy CAP standards) normal range studies, staff training, in-services to laboratory personnel and clinicians, and assist with any methodology problems and questions. This service shall be available during regular office hours on a 5 days/week basis.

4) Throughout the life of the agreement, the vendor shall provide assistance to the user in setting up and maintaining/trouble shooting user-defined assays as additional tests are brought in-house.

SERVICE AND MAINTENANCE

1) Instrument support service shall provide assistance with troubleshooting and repair of the analyzers. On-site service shall be available Monday through Friday during regular business hours (8am-5pm). The vendor shall provide a twenty-four hour/seven-day service hotline with technical support.

2) Vendor shall provide standard and routine software and hardware upgrades to the equipment hardware and operating systems, without additional charge to the Government (e.g. upgrades that correct or improve either the mechanical operations or software of the system and would keep the instrument performing optimally).

3) Vendor shall define daily, weekly, monthly, and as needed maintenance and the time required to perform each maintenance task. Vendor shall indicate which tasks are user level and which are service level.

4) Remote monitoring shall not be a substitute for on-site maintenance/repair services. However, contractor may include remotely monitored maintenance/troubleshooting software program that electronically transmits critical operational and administrative information from instruments to our internal systems via a secure Internet connection as part of their offer. This secure, encrypted technology will enable transfer of key logs, report generation, and remote services developments. It should also offer the potential to improve inventory management by enhanced troubleshooting information made available to a technical support group, a portal to access instrument logs, files, maintenance information, software version, proactive instrument operations monitoring, predictive instrument maintenance, and QC data collection for peer review.

OTHER

1) Assessment of testing needs/menus shall be evaluated as needed by the laboratory with communication to the vendor to receive pricing. There shall be easy assimilation for new tests into the pricing test lists without the need for line-item additions to the agreement.

2) Request for instrumentation upgrades or replacement due to workload increase, excessive instrumentation failures/malfunctions, breakdowns, or service calls shall be evaluated as needed/annually by the laboratory with communication to the vendor for modification of the contract. A high incidence of such problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility/clinic to its replacement with another analyzer(s) that can produce the required criteria satisfactorily to the user.

3) The vendor shall remove all equipment within 90 days after notification of the expiration of the terms of this agreement but not until the completion of new vendor's equipment installation inclusive of completed cross over studies. Vendor shall be responsible for removing the hard drive and turning it over to the VA for destruction prior to removal of any analyzer.

4) The vendor shall reimburse the facility for any costs/supplies related to tests sent to a referral laboratory when testing is not available through no fault of the facility due to reagent problems, other product issues, instrumentation failure, or other factors. The assessed damages shall be applied to the invoice in the form of a credit or deduction.

5) In the event that the any consumable, reagent, or other necessary item are found to be defective and unsuitable for use with the vendor'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 24 hours after receipt of the verbal order for priority delivery from the facility. If either circumstance has occurred, the vendor shall deliver to the facility, in the most expeditious manner possible, without additional cost to the facility, the necessary consumables in sufficient quantity so testing is not delayed.

6) This contract should assist the VAWNYHCS to pursue the goal of being a good steward in our community by eliminating, minimizing or mitigating adverse environmental impacts.

PAST PERFORMANCE

1) The vendor shall provide 4 references (two (2) VA and two (2) private sector) which can validate past experience within the last 2 years regarding:

· Costs to be reimbursed by vendor for loss of reagents due to instrument failure.

· Quality of Service (to include timeliness of service, documentation and communication of work/repairs at time of service, does service repair/fix the problem on the first site visit or does service have to return to repair/fix the problem again, are parts/tools available when service is performed or is service delayed due to ordering replacement parts), and technical support including method validation.

· Ability of the vendor to supply accurate data for annual contract renewal by required time frames and timeliness of billing reconciliation.

· Number of new assays introduced within the last 5 years.

· Customer satisfaction: meets or exceeds expected turnaround time with negligible downtime.

· Vendor shall list reagent recalls/bulletins and within the last five years. Vendor shall also list reagent unavailability due to manufacturing issues within the last five years.

· Vendor shall supply the National average of service calls per analyzer per year.

Progress and Compliance. The vendor will have access to PHI- Refer to Security Agreement with RALS and VHA.

Schedule:

Delivery of the following estimated quantities must be made on an as-needed basis: