Statement Of Need Draft.docx

STATEMENT OF NEED

1. GENERAL: The Department of Veterans Affairs, Veterans Integrated Service Network (VISN) 08, Laboratory Service, is seeking a Glucose Meter supplies, rental of equipment, whole blood glucose strips, QC controls, calibrators, and linearity reagents. All work is to be performed in accordance with the guidelines established by Federal, State, and local ordinances, with the FDA and manufacturer’s guidelines, and with all terms, conditions, provisions, schedules, and specifications provided herein.

2. SCOPE: VISN 08 requires a blood glucose monitoring system for use in inpatient settings. The system must be composed of meters for all Community based outpatient clinics and all VISN 08 inpatient facilities plus disposable test strips with associated control solutions, linearity solutions, carrying case, docking/downloading station, and data management program.

3. TERM OF CONTRACT: It is the intent of VISN 08 to establish a five (5) year Federal Supply Schedule (FSS) Blanket Purchase Agreement (BPA) for ordering repetitive point of care whole blood glucose testing supplies and lease glucometers, cost of rental in price of strips.

4. ESTIMATED QUANTITIES: This Federal Supply Blanket purchase agreement includes the rental of glucose monitoring equipment to include usage of glucose meters, carrying cases, docking stations, includes installation, connection, and integration, preventative maintenance, service, on site or over the phone training, and standard shipping of supplies. Below are estimated quantities to meet the agency need:

Description of items needed

Estimated annual quantity for all sites in VISN 08

1 RALS

5. SALIENT CHARACTERISTICS – below are the salient characteristics items needed.

5.1 Inpatient meters:

a. Scanning capability for patient armbands, controls, and test strips with capability of manual entry as a backup system.

b. Sturdy design with ergonomic features to afford ease of use (singlehanded use by operators with various sized hands.

c. Safeguards exist to ensure positive patient identification when scanning IDs or entering them manually.

d. Adequate memory to store at least 1000 results including date and time of testing as well as patient identification for result review purposes.

e. The sample requirement must be 10 µl or smaller.

f. Results must be available within five (5) seconds after application of sample.

g. Instructions that are clear and concise and written in easy-to-understand plain English.

h. Backlit operations for testing in poorly lit areas.

i. A lockout feature to disable operators who are not currently valid in the system.

j. Operational lockout for absent or failed Quality Control and expired or unapproved test strips.

k. End fill top fill sample application to allow for ease in application and minimize repeat testing due to flow errors, along with a fill trigger electrode.

l. Interfering substances should be absent or minimal. Contractor should supply list of interfering substances. Strips should not be affected by therapeutic products containing non-glucose sugars.

m. Results from the point of care system must correlate to the main laboratory method. If the reference value is less than 100 mg/dL, the meter should have 95% of results ±12 mg/dL or if the reference value is equal or greater than 100mg/dL, the meter should be ±12.5% of reference.

n. Results must be available in mg/dL units.

o. Meter/software must be capable of displaying user-configurable comments for use with critical results.

p. Meter must have the ability to be cleared of patient data prior to return to the Contractor for replacement.

q. Meter must be easy to disinfect with facility approved germicidal wipes and/or have a simple procedure to avoid contamination when testing patients.

r. Meter must include a sturdy carrying case.

s. Individually foiled wrapped test strips to minimize the risk of test strip contamination and comply with infectious disease practices.

t. Powered by AA batteries so that meter will always be ready during emergency operations or in conditions when severe weather has compromised power sources.

u. Meter has replaceable components (test strip port) to allow for replacement of contaminated port. Replaceable components reduce meter replacement process of destroying a meter, which eliminates downtime from meter repairs and money.

v. Meters must be compatible with both Unipoc and RALS database systems.

5.2 System requirement:

a. Must have a flexible, bi-directional HL7 interface that connects through the VISTA point of care interface and allows for automatic ordering of test and result entry. System should provide for future connectivity through the Cerner Millennium software.

b. Connectivity hardware for the interface (e.g., docking stations, etc.) must be of a sturdy design, capable of counter or wall mounting, and be readily available at no charge.

c. Software must be able to capture errors to prevent compromised data from reaching a patient’s medical record and alert the laboratory to deviant test results for both patients and quality control solutions.

d. Software must allow export of data management reports into spreadsheet formats (preferably Excel) including results for tight glycemic control.

e. The contractor shall provide on-site support to assist with the performance of operator training and validation studies: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), and calibration verification. Contractor shall perform all required statistical analyses and report data in an organized, clearly comprehensible format.

5.3 Other requirements:

a. Supplies of meters, strips and controls must be readily available for VISN 08 consumption.

b. Supplies must have a shelf life sufficient to provide system stability for at least 12 months.

c. Quantities of a single lot must be available to maintain the same lot number per minimum shipment of 180,000 strips.

d. Strips should be contained in individually wrapped, easy-open packaging.

e. Additional meters and docking stations must be free of charge and independent of the number of strips used.

f. Meter carrying case replacement will be free of charge and readily available.

g. Contractor will provide CLSI approved procedure for use in each laboratory.

h. Contractor will provide a standing order of the same lot number sequestered for strips of at least six (6) months.

6. ORDERING/DELIVERY: Ordering of supplies include standard delivery time of 5-7 business days. FOB destination shipping included. Contractor must furnish a designated point of contact for placing orders. Delivery frequency will be determined by each individual facility. Orders shall be delivered to the requested ordering service address specified on the order. Includes emergency repairs 24-hour phone support 7 days a week.

7. LIST OF PARTICIPATING FACILITIES IN VISN 08

All orders placed against this Agreement shall be by authorized individuals within the scope of their authority as designated by the facility participating in this agreement.

The Government estimates, but does not guarantee, the volume of purchases using this BPA. This BPA does not obligate funds. The Government is obligated only to the extent of authorized purchases made under the BPA.

Orders will be placed against this BPA using Electronic Data Interchange (EDI), FAX, paper, or oral communications.

8. MAINTENANCE:

a. Replacement meters must be free of charge and readily available.

b. Meters that are not able to be returned to Contractor for replacement due to failure to communicate caused by hardware failure (frozen meter); when data is not removable or is unable to verify that the data is removed by normal means, an alternative method (not returning to the Contractor) is acceptable.

9. TRAINING:

a. The contractor shall provide on-site support to assist with the performance of operator training and validation studies: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), and calibration verification. Contractor shall perform all required statistical analyses and report data in an organized, clearly comprehensible format.

b. The offeror will provide a specific training plan for product implementation, including a description of the training and a timeline for its completion.

c. Contractor will provide a document to be used to access user competency. The document shall be able to be used with the Talent Management System (TMS) or Medical Training Solutions (MTS) programs.

10. SERVICE:

a. The offeror will provide 24/7 customer support upon award and thereafter.

b. All FDA approved updates and upgrades for middleware, equipment, hardware, software, testing equipment, and reagents will be provided to VISN 08 at no charge.

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