Examples of Patient Safety Indicators
NOTE: This list is not meant to be interpreted as all inclusive.
Pre-analytic:
– Blood specimen collection associated patient adverse events
- hematoma
- multiple failed phlebotomy attempts (>2 by one employee or >3 total by multiple employees)
- fainting
- lapse in infection prevention/hand hygiene
- skin reaction to tape/bandage/latex
- sharps left in patient bed
- unacceptable service wait time for patient
- patient complaint (e.g., pain, customer service handling)
– Patient or Specimen Identification
- wrong patient drawn
- failure to use two patient identifiers
- patient without required identification at time of collection
- specimen mislabeled
- specimen unlabeled
– Order Entry
- incorrect order information entered (e.g., misspelled patient name, sex, DOB, fasting status, ordering clinician)
- test ordered on the wrong patient
- test not ordered (e.g., data entry error, order overlooked, no order available)
- failure to order appropriate test for clinical needs
- unintelligible clinician order
- incorrect or inappropriate test ordered
- inappropriate test frequency (e.g., too many, too few)
- incorrect date/time for test (e.g., fasting, therapeutic drug monitoring, serial timed tests)
- wrong blood product ordered
- duplicate test order
– Specimen Collection, Handling, Transport
- specimen integrity like hemolyzed, lipemic, clotted, and contaminated or diluted (e.g., incorrect order of draw, drawn above IV line)
- insufficient specimen volume or unacceptable sample-anticoagulant volume ratio
- incorrect specimen collection container (e.g., EDTA, sodium citrate, heparin, no additive)
- incorrect specimen collected (e.g., blood, saliva, urine)
- incorrect collection time
- lost or unavailable sample
- specimen special handling not followed (e.g., time to centrifugation, temperature)
- specimen transport (e.g., not transported, delay in transport, incorrect temperature, specimen container damaged or leakage)
- incorrect patient preparation (e.g., nonfasting, incorrect diet, time medication taken)
- delayed test turn-around-time due to specimen rejection requiring specimen redraw
Analytic:
– Test Result Error
- incorrect result (e.g., incorrect specimen, data entry error, technical problem, dilution error, procedure not followed)
- questionable result not identified and verified before reporting
- failure to recognize specimen type or integrity problem that affects result
- failure to recognize specimen handling or transport problem that affects result
- failure to recognize and resolve quality problem before test result reporting (quality control, calibration, instrument flags, etc.)
- delayed test turn-around-time due to analytical process problem (e.g., instrument malfunction, misplaced testing specimen, communication breakdown)
Post-analytic:
– Transfusion Services
- wrong blood product dispensed/administered
- wrong patient received product
- transfusion adverse event
– Test Reporting Error
- incorrect result reported
- test results not communicated to clinician
- critical values not reported as defined by protocol
- delayed test turn-around-time (e.g., LIS/HIS problem, pre-analytic error, analytic error)
- corrected result report not issued or not received by clinician
– Effective Utilization of Test Results
- incorrect interpretation of test results
- failure to order required follow-up test(s)
- continuing to re-order the same laboratory test without clinical need
– Outcome of Laboratory Testing
- inappropriate follow up action taken or lack of documentation on reported critical value
- failure to follow best practice protocol (e.g., coagulation monitoring, therapeutic drug monitoring, approved clinical pathway)
- failure of clinician to notify patient of abnormal test result(s) and required next steps
Additional Resources:
College of American Pathologists Q-Probes, Laboratory Benchmarking
Plebani M, Sciacovelli L, Marinova M, Marcuccitti J, Chiozza ML. Quality indicators in laboratory medicine: a fundamental tool for quality and patient safety. Clin Biochem. 2013 Sep;46(13-14):1170-4. doi: 10.1016/j.clinbiochem.2012.11.028. Epub 2012 Dec 5. PMID: 23219744.
Plebani M, Chiozza ML, Sciacovelli L. Towards harmonization of quality indicators in laboratory medicine. Clin Chem Lab Med. 2013 Jan;51(1):187-95. doi: 10.1515/cclm-2012-0582. PMID: 23023884.
Plebani M, Astion ML, Barth JH, Chen W, de Oliveira Galoro CA, Escuer MI, Ivanov A, Miller WG, Petinos P, Sciacovelli L, Shcolnik W, Simundic AM, Sumarac Z. Harmonization of quality indicators in laboratory medicine. A preliminary consensus. Clin Chem Lab Med. 2014 Jul;52(7):951-8. doi: 10.1515/cclm-2014-0142. PMID: 24622792.
Sciacovelli L, Lippi G, Sumarac Z, West J, Garcia Del Pino Castro I, Furtado Vieira K, Ivanov A, Plebani M; Working Group “Laboratory Errors and Patient Safety” of International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). Quality Indicators in Laboratory Medicine: the status of the progress of IFCC Working Group ”Laboratory Errors and Patient Safety” project. Clin Chem Lab Med. 2017 Mar 1;55(3):348-357. doi: 10.1515/cclm-2016-0929. PMID: 27988505.
Sciacovelli L, Aita A, Padoan A, Pelloso M, Antonelli G, Piva E, Chiozza ML, Plebani M. Performance criteria and quality indicators for the postanalytical phase. Clin Chem Lab Med. 2016 Jul 1;54(7):1169-76. doi: 10.1515/cclm-2015-0897. PMID: 26656613.
Plebani M, Sciacovelli L, Aita A, Chiozza ML. Harmonization of pre-analytical quality indicators. Biochem Med (Zagreb). 2014 Feb 15;24(1):105-13. doi: 10.11613/BM.2014.012. PMID: 24627719; PMCID: PMC3936970.