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Searching for inaccuracy in clinical laboratory testing using Medicare data. Evidence for prothrombin time
S T Mennemeyer1, J W Winkelman
1Department of Health Care Organization and Policy, School of Public Health, University of Alabama, Birmingham 35294-2090.
Objective:
To determine if the occurrence of health outcomes following clinical laboratory testing can be used to identify types of laboratories that may be having higher than expected error rates.
Design:
Retrospective analysis of Medicare Part B outpatient claims, Part A hospitalization bills, and death records using a case-control study.
Setting:
Medicare records from six carrier territories were sampled during the period 1985 through 1987.
Patients:
A total of 14,755 Medicare patients receiving a prothrombin time test in either a physician office laboratory or a commercial laboratory.
Outcome Measures:
Occurrence of a hospitalization for stroke or acute myocardial infarction, death, or no adverse outcome within 6 days of a prothrombin time.
Results:
In physician office laboratories where prothrombin time test volume is below 40 per month, the odds that a tested patient will experience a stroke or an acute myocardial infarction are up to 1.96 and 3.43 times greater, respectively, than for a similar patient tested in a commercial laboratory. Switching from one laboratory to another between successive prothrombin time tests increased the odds of a stroke or an acute myocardial infarction by 1.57 and 1.32, respectively. Patients in two states with strong laboratory regulatory programs had fewer adverse outcomes.
Conclusion:
Examining patient outcomes subsequent to clinical laboratory testing may be a useful tool for clinical laboratory quality assurance.
Insights
Patient health outcomes after clinical laboratory testing, particularly prothrombin time tests, can indicate higher error rates in physician office laboratories. Stronger laboratory regulation is linked to fewer adverse events.
Area of Science:
- Clinical laboratory science
- Health services research
- Quality assurance
Background:
- Clinical laboratory testing is crucial for patient care.
- Identifying laboratories with potential error rates is essential for quality assurance.
- Previous methods for identifying laboratory errors have limitations.
Purpose of the Study:
- To investigate if adverse health outcomes following clinical laboratory testing can identify laboratories with elevated error rates.
- To compare error rates between physician office laboratories and commercial laboratories.
- To assess the impact of laboratory switching and regulatory oversight on patient outcomes.
Main Methods:
- Retrospective case-control study analyzing Medicare Part A and B claims, and death records (1985-1987).
- Focused on 14,755 Medicare patients undergoing prothrombin time testing.
- Examined outcomes like stroke, myocardial infarction, or death within 6 days of testing.
Main Results:
- Physician office laboratories with <40 prothrombin time tests/month showed higher odds of stroke (1.96x) and myocardial infarction (3.43x) compared to commercial labs.
- Switching laboratories increased odds of stroke (1.57x) and myocardial infarction (1.32x).
- States with strong laboratory regulation had fewer adverse outcomes.
Conclusions:
- Patient health outcomes following clinical laboratory testing can serve as a valuable tool for quality assurance.
- Physician office laboratories with low test volumes may warrant closer monitoring.
- Regulatory oversight plays a significant role in minimizing laboratory-associated adverse events.