Creating Your IQCP for Microbiology: Real-Life Examples
Creating Your IQCP for Microbiology:
Real-Life Examples
Susan E. Sharp, Ph.D., ABMM, FAAM Director, Regional Microbiology and Molecular Infectious Diseases
Laboratories Kaiser Permanente, Department of Pathology Associate Professor, Oregon Health and Sciences University,
Department of Pathology Portland, OR
1
Objectives:
1. Identify components that should be included in an IQCP 2. Analyze the process of creating an IQCP's step by step,
using IQCP examples 3. Evaluate the impact of IQCP on quality control
procedures in the microbiology laboratory 4. Develop IQCPs for your own microbiology test systems
2
IQCP - Components
Risk Assessment (RA)
? Review of literature ? Review of manufacturer/regulatory information ? Review of your verification and historical QC data ? Review of your laboratory protocols, training, CA, PT, etc. ? Preanalytical; Analytical; Postanalytical phases (mandated by CMS) ? Risks associated with specimen, reagents, environment, testing personnel, test
system (5 mandated CMS components)
Quality Control Plan (QCP)
? Defines the type, frequency and acceptability of QC
Quality Assessment (QA)
? Develop an on going assessment of your QCP
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THESE ARE ONLY EXAMPLES !
Your plans will differ!!
? Use your own literature/manufacturer reviews ? Use your own historical QC ? Use your own risk criteria (frequency and severity) ? Use your own measures to control risks ? Use your own monitors
Use your own everything.....
4
Define your own Risk Criteria
Frequency of occurrence: Severity of harm to patient:
Unlikely (once every 2-3 years) Occasional (once per year) Probable (once per month) Frequent (once a week)
Negligible (temporary discomfort) Minor (temporary injury; not requiring medical intervention) Serious (impairment requiring medical intervention) Critical (life threatening consequences)
This is only an example (adapted from CLSI EP23) 5
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