5-PROCESS CONTROL
Laboratory quality management system-BS3 [Link]
Intructor: Mariam Hassan
5-1:OVERVIEW
• Role in quality management system:
The laboratory must be proactive in ensuring that the samples it receives meet all of the
requirements for producing accurate test results.
• The laboratory handbook:
Important information that should be included in the lab handbook:
✔ Contact names and telephone nb of personnel
✔ Name and address of lab
✔ Hours of operation of the lab
✔ List of tests that can be ordered
✔ Information on smple collection requirements
✔ Sample transport requirement
✔ Description of how urgent requests are handled
5-2:COLLECTION AND PRESERVATION:
• Lab’s responsibilities:
The lab can help to ensure good samples by providing collection information to health
care personnel at the collection site,making sure that appropriate containers and
collection supplies are available,defining a good labelling system and checking all
samples carefully when they arrive in the lab.
• Sample collection requirements:
✔ Patient preparation
✔ Patient identification
✔ Type of sample required
✔ Type of container
✔ Sample labelling
✔ Special handling
5-3:SAMPLE PROCESSING
• Verification of quality:
-verify the sample is properly labelled ,adequate in quantity,in good condition and appropriate
for the test requested.
-record sample information
• Rejection of samples:
The following are examples of samples that should be rejected:
✔ Unlabelled sample
✔ Broken tube
✔ Insufficient patient information
✔ Sample label and patient name on the test request form do not match
✔ Hemolysed samples(depending on test)
✔ Non fasting samples for test require fasting
✔ Inadequate volume for the quantity of preservative
✔ Insufficient quantity
✔ Prolonged transport time
• Register or log:
The lab should keep a register of all incoming samples
The register should include :
✔ Date and time of collection
✔ Date and time the sample was received in the lab
✔ Sample type
✔ Patient name and demographics ,as required
✔ Lab assigned identification
✔ Tests to be performed
NOTE: Handle all samples as if they are infectious
5-4:SAMPLE STORAGE
• Transport must be managed carefully in order to maintain integrity of the sample,giving
attention to temperature,preservation needs ,special transport containers and time
limitations.
• Classification:
Sample transport requirements are based on the category of sample being transported
infectious vsubstancews are classified as category A or category B
Category A: infectious substances capable of causing permanent disability or
life-threatening or fatal disease to humans or animals.
Category B: infectious substances that do not meet the criteria for inclusion in catergory
A
• Packaging requirements:
The primary container,the secondary container,the outer container.
There is specific packaging for samples requiring shipment on dry ice
5-5:INTRODUCTION OT QUALITY
CONTROL
• What is QC?
- QC is the part of quality management focused on fulfilling quality
requirements (ISO 9000:2000).Simply put, it is examining “control”materials of
known substances along with patient samples to monitor the accuracy and
precision of the complete analytic [Link] is required for accreditation
purposes.
- The goal of QC is to detect ,evaluate and correct errors due to test system
failure ,environmental conditions ,or operator performance,before patient
results are reported.
- Different QC processes are applied to monitor quantitative ,qualitative and
semiquantitative tests.
QUALITY CONTROL FOR
QUANTITATIVE TESTS:
• Graphically representing control ranges:
the common method for this graphing is the use of levey-Jennings charts.
In order to develop levey-Jennings charts for daily use in lab ,the first step is the
calculation of the mean and SD of a set of 20 control.
• A levey –Jennings chart can be drawn ,showing the mean value as well +-1,2
and 3SD
• Interpreting quality control data:
QC sample tested along with patient’s samples can now be used to determine
if daily runs are “in control”. A control sample must be run with each set of
patient samples. Run the control and plot it on the Levey–Jennings chart. If the
value is within +2 SD, the run can be accepted as “in-control”.
The values on the chart are those run on days 1, 2 and 3 after the chart was
made. In this case, the second value is “out of control” because it falls outside of
2 SD. When using only one QC sample, if the value is outside 2 SD, that run is
considered “out of control” and the run must be rejected .