Laboratory Management and Informatics: Quality Systems and the Wired Laboratory
Quality systems, validation, and the wired laboratory
Management and informatics questions reward systems thinking. Know CLIA '88 and CAP accreditation requirements, the distinction between validation (establishing performance of a laboratory-developed test) and verification (confirming performance of an FDA-cleared test in your own setting), proficiency testing, competency assessment, and document control. Understand the error taxonomy: preanalytical (labeling, fixation, transport), analytical, and postanalytical (reporting, interpretation). Most errors are preanalytical, so barcoding, specimen tracking, and two-identifier verification matter more than instrument upgrades.
Informatics: the LIS is a clinical system. Know HL7 v2 messaging and FHIR resources conceptually, synoptic reporting structures, interface validation, downtime procedures, and the requirement to validate digital pathology before primary diagnosis. Cybersecurity and data privacy are operational risks, not IT trivia.
Traps: assuming FDA clearance eliminates local verification; confusing a corrected report with an amended one; treating turnaround time as a single average rather than a percentile; and choosing a software fix for what is actually a workflow problem.
Rule of thumb: no patient result until the method is validated, staff are competent, and the report is traceable to the specimen.
Worked example: introducing a new IHC marker. Document antibody, retrieval, dilution, and detection; compare accuracy and precision against a reference method; define interpretative criteria; obtain pathologist sign-off; enroll in proficiency testing; then go live. Skipping any step leaves an unvalidated result in the record.