Information Management and Informatics
Systems and standards
A laboratory information system (LIS) manages orders, results, and workflow; it exchanges data with the electronic health record and reference labs through interfaces built on standards such as HL7 and, increasingly, FHIR. Terminology matters: LOINC codes observations and tests, SNOMED CT codes clinical concepts, ICD-10 codes diagnoses, and CPT codes procedures for billing. A frequent trap is assigning LOINC to diagnoses or CPT to observations.
Data integrity and security
The three security aims are confidentiality, integrity, and availability. Controls include unique user IDs, role-based access, strong authentication, audit trails that cannot be altered, encryption, and periodic access review. Audit trails support both quality review and HIPAA accountability. Downtime planning covers manual result reporting, later reconciliation, and backup/restoration testing - a backup never restored is not a verified backup.
Validation and automation
Any change to the LIS (new build, interface, or calculation) requires documented validation before go-live and again after significant modification. Autoverification is acceptable only with documented rules, validated ranges, delta and critical-value logic, and periodic review of overridden or flagged results. Middleware can add rules without replacing the LIS. Barcoding at collection and at accessioning is the strongest defense against misidentification.
Worked example
A laboratory enables autoverification for chemistry panels. Before go-live it must validate that results inside defined limits pass to the chart, while results outside limits, delta failures, and critical values are held for review; it must also document who approved the rules and retain the validation record. Afterward it reviews a sample of held and released results on a schedule.
Reporting quality
Critical value notification requires documented read-back and time to notification. Dashboards of key indicators (TAT, rejected specimens, corrected reports) turn data into management action.