SOW_-ACL_ELITE_FY17.docx

STATEMENT OF WORK

Coagulation Analyzer Usage Naval Hospital Camp Pendleton (NHCP)

· BACKGROUND: The Laboratory Department at NHCP services more than 25 hospital departments and 14 outlying clinics. As NHCP’s Lab is relied upon for the reference testing of all of the base’s clinics, it is imperative that the analyzers procured by the Laboratory Department provide the highest volume and variability of tests, coupled with the smallest number of necessary analyzers to achieve the Command’s testing needs. In the past year, testing volumes were greater than 5,000 tests or 400 tests per month. Lastly, because NHCP’s Lab Department routinely experiences very high technician turnover, our laboratory features streamlined, robust systems with easy to learn and easy to use interfaces and functions.

· SCOPE: The Contractor shall furnish all labor, tools, supervision, material, parts, and equipment necessary to operate two (2) coagulation analyzers for the hospital laboratory. The materials purchase agreement will also include: Annual training for a total of two (2) operators with room and board for each completed year of customer agreement upon request. There shall be a warranty of 60 months, covering all parts, labor and travel with service during standard business hours (5 days, 8 hours). In the event that both coagulation analyzers are out of service, technical service must be provided 24 hours a day, 7 days a week.

· OBJECTIVES:

· Obtain a Coagulation testing platform that can support the wide breadth of testing that our Physicians require. This includes PT, APTT, INR, Fibrinogen, and D-Dimer. Receive a materials purchase agreement for leased equipment. Lab leadership does not wish to purchase any analyzers.

· Partner with a vendor who can provide continuing education options to our civilians who require continued training in order to maintain accreditation and licensure.

· Must have consolidated testing and functions onto one analyzer or testing system due to limited space.

· Tasks/Requirements:

· Require a system that does not require manual manipulation for Factor Assays or dilutions

· Must have the ability to support multiple reagent configurations onboard the analyzers.

· Must have a system that allows end user to define its own release criteria.

· Require that same lot number of reagents be used for greater than 12 months.

· Must have a sample bar code reader included with analyzer lease.

· Analyzer must auto-detect adequate reagents for aspiration and analysis.

· Must be capable of diluting patient samples onboard.

· Require that the analyzer be capable of automatically rerunning and automatically reflexing tests where appropriate.

· Must have Stat PT results in less than 5 minutes in order to support Provider/Physician needs.

· Analyzer must not have a delay of greater than 30 seconds to aspiration once Stat specimen is ordered.

· Analyzer’s data management capabilities must include quality control data and Levey-Jennings Charts.

· Equipment must have bidirectional interface capability.

· Analyzer must keep onboard maintenance records.

· Testing system cannot be greater than 32 inches deep as laboratory is equipped with countertops of 32 inches in depth.

· Laboratory must have the ability to establish its own thresholds for abnormal results

· Analyzer must be able to auto-release specimen results when results are normal.

· Desire a system that allows for manual programming functionality.

· Must have testing platforms that will automatically flag tests producing abnormal results. This automatic feature would ease the analytical burden placed upon our technicians who must identify and address all abnormal results for accuracy and clinical relevance.

· Must have LIS interface that is compatible with CHCS and is already approved for use in DOD facilities.

· Analyzer must have capability to transfer both patient and quality control results automatically across the interface to the LIS.

· Must have ability to handle downtimes for maintenance is limited. Must have analyzer whose maintenance can be performed very quickly.

· Analyzer must keep onboard maintenance records including trackable audit trails to meet or exceed College of American Pathologists (CAP) requirements.

· GOVERNMENT FURNISHED PROPERTY/TASKS: None.

· SECURITY REQUIREMENTS (IF APPLICABLE): None.

· PLACE OF PERFORMANCE: Naval Hospital Camp Pendleton (Building H-200), Laboratory Department

· PERIOD OF PERFORMANCE/DELIVERY: Period of Performance (Analyzer Usage): October 1, 2016 through September 30, 2017.

· OTHER TERMS AND CONDITIONS:

· Must be 510K compliant if patient information must be stored on analyzers.