- Last Update On : 2013-01-28
Evaluation of a new method or instrument must be completed prior to introduction into the laboratory. Timely and efficient completion of the evaluation requires a well thought out plan using clearly defined criteria.
The following information should be evaluated and found to be consistent with the laboratory’s operational goals before a method or instrument is considered for further evaluation.
How will the test be used?
- How often is the test being sent to a reference laboratory?
- Will it become a standard of medical care?
- Is this an individual, departmental, or general medical staff request?
- Which physician groups will order the test?
- How many tests will be ordered per week?
- What is an acceptable turnaround time for inpatients and outpatients?
- Does the test need to be available on a stat basis?
- How would local availability of this test improve medical practice?
- How much floor space is required?
- What are the electrical requirements? Is a UPS required? Will it be supplied?
- How much heat will be generated?
- How are temperature fluctuations tolerated?
- What range of relative humidity is tolerated?
- What is the effect of static electricity?
- Are there known hazards?
- Is ancillary equipment required? (refrigerator, centrifuge, vortex, mixer, etc)
- What are the storage requirements at the projected test volume?
- How much reagent preparation time is required?
- How long are the reagents stable on the instrument?
- How many tests can be stored on-board for each analyte?
- How many analytes can be stored on-board at one time?
- How much down time is required to replace regeants?
- Is recalibration or control required after each reagent lot change?
- How much lot to lot bias occurs for each analyte?
- Is "on time" delivery of the same reagent lot available?
- Does the instrument inform the operator of on-board inventory?
- Are the reagents packaged in convenient size containers or volumes?
- What is the reagent shelf life?
- How many consumables will be discarded (sample cups, cuvettes, microplates, pipettes, tips, tubing, lamps)?
- Is a recycling program available?
- Are any of the disposables considered biohazards?
- How much time is required for daily, weekly, & monthly maintenance?
- What is the start up time from stand-by?
- What is the shut down time?
Sample Throughput Rate & Analysis Time
- How many minutes elapse from introduction of the first sample to results.?
- How much time elapses between subsequent samples & results?
- What is the maximum number of samples performed per hour?
- Will the system auto-dilute and automatically rerun dilutions?
- Does stat interrupt capability exist? If so, what is the delay?
- Is continuous random access testing available?
- Is turnaround time significantly different than the current method?
- How many different tests can be run on each sample in a single run?
- What is the sample size?
- What is the dead space volume?
- Is primary tube sampling available?
- Is closed container sampling available?
- Can tubes of different size be intermixed?
- How many samples can be loaded at one time?
- What specimen types can be run: Serum, plasma, urine, CSF?
- Do any tests require special sampling (e.g. tubes, transportation)?
- What is the frequency and cost of calibration?
- Is calibration performed manually or automatically?
- Can other vendor's calibrators be used?
- Can the slope and intercept be changed?
- How many calibrations for an analyte can be stored for use?
- Do calibrators include the full range of claimed linearity?
- Does the vendor provide a 0 calibrator? If so, what is it?
- Can aqueous standards be used?
- How often must controls be run?
- How many levels of control must be run?
- Is on-line quality control review available?
- Do protocols and actual examples exist for standardized quality control ranges across multiple like analyzers?
- What is the complete list?
- What tests are planned for release in the next quarter?
- Are user defined tests available?
- Are there matrix issues for patient samples, controls, calibrators, or proficiency test samples?
- Are standard methods, units, and reference ranges used?
- What lower limit of detection is claimed for each test?
- What are the linearity claims for each test?
- How does the analyzer report values above the upper limit or under the lower limit?
- Are any tests interfered with by hemoglobin, lipid, bilirubin?
- Do any other commonly used clinical substances (drugs) cause interference?
- Is carryover a problem for any test?
- How reliably has the instrument performed in other users’ laboratories?
- How has the instrument performed in proficiency surveys?
- Is proficiency testing available from the usual sources?
- Is training offered on-site and/or at the manufacturer's facility?
- How many training slots are offered per instrument?
- Is field support available for repeated on-site training?
- Are self-diagnostics available? Via telecommunication?
- What is the repair record of analyzers in the field?
- What is the average down time experienced by other users?
- Is field service local? How many service technicians cover the territory?
- How much time is allowed before service responds by phone?
- How much time is allowed before service arrives on-site?
- What type of back-up is available in the event of significant down time?
- Can operators walk away from the instrument?
- How many like instruments can one operator run if they are in close proximity?
- Is the interface bidirectional?
- Has the instrument been interfaced to our LIS at other installations?
- Can the analyzer be interfaced during evaluation?
- Is the interface provided without charge?
- Is bar code capability available?What are the specifics of placement?
- What is the direct cost per reportable (billable) result?
- What purchase options are available (lease, purchase, reagent rental)?
- What does the service contract cost? Is it necessary?
- What is the warranty?