36C26218Q0578-002.doc

VISN 22

VISN 22 GLUCOMETER COST PER TEST (CPT) BLANKET PURCHASE AGREEMENT (BPA) STATEMENT OF WORK (SOW)

1. INTRODUCTION:

VISN 22 is seeking to establish a single award CPT BPA for Point of Care Glucose testing. Quotes shall include all the necessary equipment/analyzers, service/maintenance, training, reagents/cartridges, consumables, supplies, etc., to perform the tests described within this solicitation and all attachments.

The quoted equipment/analyzers shall be specialized instruments for the testing of specific parameters of whole blood for therapeutic monitoring and routine testing. The analyzer(s) provided by the contractor shall be portable, bedside units for use primarily in the clinical areas of the hospital and CBOCs.

2. DEFINITION/ACRONYMS:

1.1. 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 and software necessary for data management and the generation and reporting of a test result in VISTA.

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

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

1.2. CAP - College of America Pathologists

1.3. JC – Joint Commission

1.4. QC – Quality Controls

1.5. CBOCs - Community Based Outpatient Clinics

1.6. Analyzer - Meter and charging station if applicable

1.7. Downloader - Base unit for downloading information from meter to data management system.

2. GENERAL REQUIREMENTS:

2.1. Analyzers/Downloaders - All 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 result for sample specimens up to the manufacturer’s defined maximum test per hour without excessive malfunctions, breakdowns, or service calls.

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

2.1.2. The contractor shall provide all upgrades to the equipment hardware and operating system software, at no additional cost to the Government. Hardware and software upgrades shall be provided as they become commercially available and at the time they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of the equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer supported by the contractor, etc. This does not refer to replacing the original equipment provided under the BPA unless the upgrade provides significant changes in the equipment operational capability, as determined by the VA. These enhancements shall be delivered and installed at the medical facility within 60 days of issuance.

2.1.3. The contractor shall provide technical support for the software programs required for data management and interfacing results into VISTA.

2.1.4. An operator’s manual shall be furnished with each instrument supplied to VA as the equipment is delivered and updates to the manual shall be provided.

2.1.5. Contractor shall supply a meter specific carrying case/tote box for each meter.

2.1.6. Contractors 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 ft within a 12” X 12” X 12” space.

2.1.7. See Attachment B – Test Schedule and Volumes for analyzer and downloader quantities.

Meets the minimum requirement described in Section 3.1 above (y/n)?

Describe how the minimum requirement is met or exceeded:

File name of Contractor’s attachment, if providing additional supporting documentation:

2.2. Reagents/Cartridges/Consumables – See Attachment B – Test Schedule and Volumes for estimated annual test volumes.

2.2.1. Contractor shall supply all facilities with a six (6) month supply of a single lot of reagent.

Meets the minimum requirement described in Section 3.2 above (y/n)?

Describe how the minimum requirement is met or exceeded:

File name of Contractor’s attachment, if providing additional supporting documentation:

2.3. Maintenance and Repairs -

2.3.1. 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.

2.3.2. 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. Contractor shall provide technical support service to assist in troubleshooting 24-hours per day, seven days per week including Federal holidays.

2.3.3. Contractor shall provide written report/email of notification of corrective action.

2.3.4. Should the repair record of any individual piece of laboratory equipment reflect a downtime greater than 5% 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.

Meets the minimum requirement described in Section 3.3 above (y/n)?

Describe how the minimum requirement is met or exceeded:

File name of Contractor’s attachment, if providing additional supporting documentation:

2.4. Training - At a minimum, contractor shall provide training in accordance with the terms, conditions, and provisions of contractor’s existing Federal Supply Service (FSS) Contract for performance of CPT services, if the contractor has an existing FSS Contract. Providing a quote that includes training, above what is minimally stated in the contractor’s FSS contract, is highly recommended.

Meets the minimum requirement described in Section 3.4 above (y/n)?

Describe how the minimum requirement is met or exceeded:

File name of Contractor’s attachment, if providing additional supporting documentation:

3. SPECIAL REQUIREMENTS: In addition to the general requirements for the Cost-Per-Test requirements stated above, the contractor shall meet the following special requirements:

3.1. The contractor’s unit shall have software that is fully VISTA compatible, capable of simultaneous data transfer from the unit to facilities middleware 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. This may require the use of middleware to get patient results from the instrument to VISTA (which will be under a separate contract).

3.2. Must connect with standard HL7 interface.

3.3. The system must be FDA approved for waived point of care blood glucose testing for professional use.

3.4. The system shall be easily able to accommodate standard infection control practices such as isolation protocols and cleaning in-between patients.

3.5. Provide download interval lock out, QC lock out and operator lock out.

3.6. QC shall be available in Levy Jennings format, and statistical reporting available (may be middleware).

3.7. Must accept sample types fresh capillary, venous, and arterial whole blood for testing.

3.8. Shall provide data management of patient and QC results included with remote access (may be middleware).

3.9. Shall be capable of operating at high altitudes with no interferences.

3.10. Shall provide calibrations per CAP requirements.

3.11. Must perform an automated check for sample quantity, temperature, and humidity variation.

3.12. Shall provide ease of use.

3.13. Shall be easy to troubleshoot and have minimal maintenance.

3.14. All equipment, controls, calibrators and reagents shall be included in the CPT.

3.15. Instruments shall be moveable for transport to bedside without recalibration.

3.16. Instrument must have scanning capabilities for operator ID, patient ID, and reagent lot numbers.

3.17. Information contained in transmission to external data management system must include device unique identifier, operator ID, patient ID, test results, QC identifiers, reagent lot numbers and comments.

3.18. Analyzer must be capable of test result entry for manual point of care tests.

Meets the minimum requirement described in Section 4 above (y/n)?

Describe how the minimum requirement is met or exceeded:

File name of Contractor’s attachment, if providing additional supporting documentation:

4. TRANSITION PERIOD:

Upon award, the transition period for the awarded contractor to have all required analyzer’s, peripherals, consumables, training, correlation studies, reagents, controls, interfaces, etc., installed and fully operational shall be within 30 calendar days after award of BPA. Contractors shall provide with its quote a plan for transitioning services from the incumbent contractor to the new awarded contractor. Quotes that do not provide a transition plan will not be considered for award. Contractor’s submitted transition plan shall not exceed the required 30 day period contained herein. Failure of the contractor to conform to the transition period shall be considered as sufficient cause to terminate contract for cause under the Termination for Cause clause of the contract. The VA shall have sole discretion in the decision to terminate for failure to comply.