36C24818Q0241-002.docx

Attachment B 36C24818Q0241

Statement of Work / Specifications General Information A contract is desired that will provide a Lease / cost-per-test basis, instrumentation, supplies, repair and equipment maintenance for the performance of arterial blood gases.

The end result expected from this contract is the ability to complete an average of 1500 blood gas /pH/ hemoximetery/electrolyte samples per month on three (3) analyzers at the Gainesville location and the ability to complete an average of 150 blood gas / pH/ and hemoximetery samples per month on two (2) analyzers at the Lake City location. The vendor shall supply all equipment, reagents, calibration and quality control materials required to meet this goal.

Multiple instruments are needed to assure uninterrupted testing availability. Connectivity with the VISTA patient record system for download of sample results shall be proven, the vendor shall provide a quality assurance (Q&A) program which includes ongoing comparison of each instruments performance as related to similar instruments. This peer group comparison program shall provide at least monthly documentation of instrument accuracy and precision. The offeror shall also provide for periodic site-visits by their service representative for all routine maintenance including replacement parts, 24/7 help desk troubleshooting assistance and a guaranteed response time for repair visits by a company technical representative.

Delivery:

a. The Contractor shall deliver all equipment required under this SOW within thirty (30) calendar days or less from the date of award, unless otherwise directed by the Contracting Officer (CO).

i. Due to the large quantity of pumps, this will be a staged delivery that will be decided on during a post-award kickoff call. This will be mutually agreed on between the COR and the Contractor.

b. Delivery of equipment shall be made to two locations:

i. 1601 SW Archer Rd Gainesville FL, 32608 And

ii. 619 S. Marion Avenue Lake City, FL 32025

c. Delivery shall be made during normal NF/SG VAMC warehouse business hours excluding all federal holidays.

i. NF/SG VAMC warehouse business hours are Monday – Friday, 7:00 am – 11:30 am and 12:30pm – 3:00pm.

ii. Federal holidays are: New Year’s Day, Martin Luther King Jr. Day, President’s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day.

Measurement Gainesville location (3 analyzers) Each instrument shall be capable of analysis of pH, pCO2, pO2, K (potassium), Na (sodium), Cl (chloride), iCa (ionized calcium), Glu (glucose), tHb (total hemoglobin), HbO2 (oxyhemoglobin), HbCO (carboxyhemoglobin), and MetHb (methemoglobin). The oximeter shall measure (tHB, HbCO, HbO2 and MetHb) on a 128 wavelength band to remove susceptibility to error caused by cardiac dyes and to suppress interference from other substances such as intralipids. Pleural fluid Ph Lake City location: (2 analyzers) Each instrument shall be capable of analysis of pH, pCO2, pO2, tHb (total hemoglobin), HbO2 (oxyhemoglobin), HbCO (carboxyhemoglobin), and MetHb (methemoglobin). The oximeter shall measure (tHB, HbCO, HbO2 and MetHb) on a 128 wavelength band to remove susceptibility to error caused by cardiac dyes and to suppress interference from other substances such as intralipids. Pleural fluid Ph Quality control (QC) Each instrument shall incorporate an automated external quality control system which allows setting user preferences for sampling intervals, acceptable result limits and allow for error driven lockout parameters. The ability to automatically sample multiple QC material lots concurrently is required. Each instrument shall automatically compute QC statistics. QC results and statistics shall be available for user and supervisor review at the instrument. The instrument shall automatically notify users of failure to meet the requirements of QC protocols.

Gainesville location: 4 levels of QC per day including 1 high pO2 / 7 days per week Lake City location: 3 levels of QC per day / 7 days per week User Help/ Maintenance Support Each instrument shall incorporate a system to notify users of failure to meet operational and/or QC protocol requirements. Providing a troubleshooting program on use and maintenance of the instrument is also desired.

The Vendor shall agree to provide remedial repair in the event of continued instrument failure to produce acceptable quality control results. In addition the offeror shall agree to provide remedial repair in the event of failure to produce acceptable results on two consecutive CAP surveys (Federal regulations require laboratories to participate in quality assurance programs external to both user and contractor).

The instruments should be in place and ready for clinical use within 2 weeks of concurrence of the contract. The contract price should include delivery, installation and setup of the equipment. Equipment setup should include initialization, calibration. Calibration verification linearity and preliminary assurance of the acceptability of quality control results. The vendor should agree to train personnel on use, maintenance and troubleshooting of the instruments.

Remote instrument control The ability to view instrument status to include QC and calibration status is desired. Remote access and analyzer control with instruments is needed for the supervisor / blood gas coordinator to be centrally located between both facilities.