QUALITY CONTROL IN MICROBIOLOGY Flashcards
Internal activities ensuring diagnostic accuracy, defined as measures designed to ensure the medical reliability of laboratory data
Quality control
External activities ensuring positive outcomes
Quality assurance
Eliminates redundant motion, reduces waste, and focuses on client value
LEAN concept
Six Sigma goal
“Reduces defects by minimizing process variation”
Six Sigma methodology
“DMAIC: A process introduced by Motorola in 1986 to reduce defects by minimizing variation in processes through metrics measurement”
Accuracy, reliability, and timeliness of reported test results
Laboratory quality
TJC laboratory goals
“Improving patient identification
ISO - Medical laboratory requirements for quality and competence
“ISO 15189:2007”
ISO -General requirements for the competence of testing and calibration laboratories
“ISO/IEC 17025:2005”
ISO- General requirements for the competence of providers of proficiency testing schemes
“ISO/IEC 17043:2010”
Pre-analytical stage steps in laboratory testing
Test order/requisition, Collection of samples, Transport
Analytical stage steps in laboratory testing
Gram stain/Direct Microscopy, Culture, Screening test, Biochemical test, Confirmatory tests, QC, QA
Post-analytical stage steps in laboratory testing
Review of result, Encoding in LIS, Critical values, Notifying physician, Disposal of agar plates
Critical value indicating systemic infection
Positive blood cultures
Critical value indicating CNS infection
Positive CSF Gram stain or culture
Critical value indicating fungal infection in CSF
Positive Cryptococcal antigen test
Critical value for identifying mycobacterial infection
Positive acid-fast stain
Critical value in genital site of pregnant women
S. agalactiae or herpes simplex virus
Critical value indicating parasitic infection in blood
Blood smear positive for malaria
Critical value in surgical wound infections
Streptococcus pyogenes in a surgical wound
Critical value suggestive of gas gangrene
Gram stain showing large boxcar-shaped gram-positive rods
Critical value for respiratory or zoonotic infections
Significant pathogens (B. pertussis, Brucella, Legionella)
QC monitoring for Gas Pak jar, Autoclave temperature
Each use
QC monitoring (Catalase, Oxidase, Refrigerator, Freezer, Incubator, Anaerobic chamber)
Daily
QC monitoring for (Gram stain, Antibiotic disks, Autoclave spore testing, Reagents)
Weekly
QC for monitoring (Rheostat control, Face velocity of BSC)
Monthly
QC for monitoring (Cleaning and adjustment of Microscope)
Quarterly
QC for monitoring (Centrifuge speed, RPM)
Semi-Annually
QC for monitoring (Airflow of biosafety cabinet, Biohazard hoods, Accuracy of balances)
Annually