Point of Care The Journal of Near-Patient Testing & Technology · 2003 · 11 citations · 7 references
Total Quality ManagementEffective UsePoint-of-care TestingEngineeringVerificationHospital MedicineClinical SystemPrimary CareSystems EngineeringMedical StandardsQuality Control PracticesMedical Error PreventionReliabilityClinical SafetyConstruction Quality ControlClinical Decision SupportQuality ControlMarketingNursingHealth SystemsQuality AssurancePatient SafetyHealthcare Quality AssuranceNear Patient TestingImproved Product QualityPatient ManagementMedicineHealth InformaticsEmergency Medicine
Why are we using 1950s quality control and quality assurance concepts with 2003 technologies? In 90 years of clinical testing, methods have evolved from tedious manual procedures to fully automated, computerized, instrument systems. Quality control and quality assurance practices, however, have not kept pace with technological innovations. These mandated and often manually performed quality control practices are too cumbersome and complex for effective use at point-of-care testing performed by nonlaboratory practitioners whose primary focus is patient care. Additionally, the special expertise required for quality control data interpretation, troubleshooting, and initiating corrective actions usually is not present at the patients' bedside. In a 1999 study, the U.S. Institute of Medicine concluded that up to 100,000 hospitalized Americans die each year from preventable medical errors. While the number of serious errors attributable to point-of-care testing is not known, the testing environment (patient bedside) and the inability of operators to prospectively recognize analytical system failures are reasons for concern. The Institute of Medicine study recommends adopting several protocols to prevent “human” errors, including incorporating safeguards into the system. The GEM Premier 3000® with Intelligent Quality Management (Instrumentation Laboratory, Lexington, MA) takes advantage of today's technological capabilities to provide these safeguards by introducing a new quality paradigm. With today's instrumentation, it is possible to move from operator-performed quality practices to manufacturer-assured quality. Intelligent Quality Management totally manages the testing process and effectively guarantees, without operator intervention, the quality performance of this point-of-care analyzer. This greatly simplifies the testing process and allows caregivers to use the test data in an environment of “assured quality` and to focus, appropriately, on the patient.
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