A Reportable Range is the range of test results that a laboratory can reliably measure and report to doctors and patients. Think of it like a ruler that can only measure between 1 and 12 inches - anything outside these limits can't be measured accurately. In medical testing, knowing these ranges is crucial because it tells healthcare providers what results they can trust. Laboratory professionals work to validate and maintain these ranges to ensure test results are accurate and reliable for patient care.
Established and validated Reportable Range for new diagnostic tests across multiple platforms
Performed monthly verification of Reportable Range for critical care testing instruments
Led team in expanding Reportable Ranges for high-sensitivity tumor markers
Typical job title: "Clinical Laboratory Scientists"
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Q: How would you establish a new reportable range for a test method?
Expected Answer: A strong answer should explain the process of gathering control materials, running validation studies, and documenting results. They should mention working with manufacturers' guidelines and regulatory requirements, plus describe how they would train staff on new ranges.
Q: What steps would you take if test results consistently fall outside the reportable range?
Expected Answer: Should discuss investigating the cause, including instrument maintenance, reagent quality, and possible method modifications. Should mention documenting incidents, communicating with healthcare providers, and implementing corrective actions.
Q: How do you verify reportable ranges on a regular basis?
Expected Answer: Should explain routine quality control procedures, including running controls at different levels, documenting results, and recognizing when ranges need adjustment.
Q: What documentation is needed for reportable range studies?
Expected Answer: Should describe maintaining records of validation studies, quality control data, and any range modifications. Should mention regulatory requirements for documentation.
Q: What is a reportable range and why is it important?
Expected Answer: Should explain that it's the range of values a lab can reliably report and why accurate ranges are crucial for patient care decisions.
Q: What do you do when a result falls outside the reportable range?
Expected Answer: Should explain basic procedures like diluting samples, notifying supervisors, and following laboratory protocols for handling such situations.