QUA L IT Y M A N A G EM E NT

I ELA C . RO NQ UILL O, RMT

PREPARED BY: MAR
TOTAL QUALITY MANAGEMENT FRAMEWORK
QUALITY ASSURANCE VS. QUALITY CONTROL

QUALITY CONTROL In the medical laboratory is a statistical process used to mo

• _____________________
nitor and evaluate the analytical process that produces patient results.
 Quality control refers to the measures that must be included during each assay r
un to verify that the test is working properly

• ______________________
QUALITY ASSURANCE Is defined as the overall program that ensures that the fina
l results reported by the laboratory are correct.
 QUALITY ASSURANCE

QUALITY ASSURANCE has a wide scope and encompasses 3 phases namely:

QUALITY CONTROL

• KINDS OF QUALITY CONTROL

1. INTRALAB (INTERNAL QC)
- Involves the analyses of the control samples together with the patient specimen
s
- detects changes in performance in between the present operation & stable ope
ration
- important for the daily monitoring of accuracy and precision of analytical met
hods
- detects random and systematic errors
QUALITY CONTROL

• 2. INTERLAB (EXTERNAL QC)

• It involves proficiency testing programs that periodically provides samples of un
known

• Important in maintaining long-term accuracy of analytical methods

• determines estimates of the state-of-the-art interlaboratory performance
• difference of more than 2 in the results indicates that a laboratory is not in agree
ment

• With the rest of the laboratories included in the program

OBJECTIVES OF QUALITY CONTROL

1. TO CHECK THE STABILITY OF THE MACHINE

2. CHECK THE QUALITY OF REAGENTS
3. CHECK TECHNICAL ERRORS (MOST COMMON-PIPETTING)
 PARAMETERS OF QUALITY CONTROL

1. SENSITIVITY - ability of an analytical method to measure the smallest concentration of the analyte of interest.
2. SPECIFICITY - ability of an analytical method to measure only the analyte of interest, true value
3. ACCURACY - nearness or closeness of the assayed value to the true or target value
4. PRECISION OR REPRODUCIBILITY - ability of an analytical method to give repeated results on the same samp
le that agree with one another
5. PRACTICABILITY - the degree by which a method is easily repeated
6. RELIABILITY - ability of an analytical method to maintain accuracy and precision over an extended period of ti
me
7. DIAGNOSTIC SENSITIVITY - the ability of the test to detect the proportion of individuals with that disease who
test positively with the test. Screening test.
8. DIAGNOSTIC SPECIFICITY - ability of the test to detect the proportion of individuals without the disease who test ne
gatively with the test. Confirmatory test.
 INTERPRETATION OF QUALITY CONTROL

• TREND- values for the control that continue to either increase or decrease over a peri
od of 6 consecutive days (maybe due to deterioration of standard or a change in reage
nt lot)
• SHIFT- 6 or more consecutive daily value that distribute themselves on one side of th
e mean value line but maintain a constant level (maybe due to deterioration of standar
d or a change in reagent lot) - LJ QC chart
• OUTLIERS- are control values that are far from the main set of values
WESTGARD MULTI-RULES
VARIATIONS
TYPES:
1. RANDOM ERROR - INDETERMINATE/ IMPRECISION

• - Present in all measurements, due to chance

• - Basis for varying differences between repeated measurements
• - Due to instrument, operator and environmental conditions
• 2. SYSTEMATIC ERROR - PREDICTABLE/ERRORS-IN-ONE-DIRECTION/DETERMINATE/ INACCURACY
• - detected as either positive or negative bias, often related to calibration problems, deterioration o
f reagents and control materials, contaminated solutions, unstable inadequate reagent blanks.

•
PRE-ANALYTICAL ERRORS

• 1. Incorrect patient identification

• 2. Wrong specimen container
• 3.Improper patient preparation
• 4. Mislabeled specimen
• 5. Incorrect order of draw
• 6. Incorrect anticoagulant to blood ratio
• 7. Improper mixing of sample and additives
• 8. Incorrect specimen preservation
• 9. Correct used of tubes for blood collection
• 10. Mishandled specimens transport and storage
ANALYTICAL ERRORS
1. Improper incubation and timing
2 incorrect volume of specimen and reagent
POST-ANALYTICAL ERRORS
1. Unavailable or delayed laboratory results
2. Incomplete laboratory results
3. wrong transcription of the patient's data and lab results
LABORATORY SAFETY MANAGEME
NT