This topic is about quality assurance in clinical lab

1. Process Control — Sample
Management
Lecture 12

2. Sample Management in QMS
Sample management is a part of process
control in the Quality Management
System (QMS).
Accurate testing depends on high-quality
samples.
Proactive management ensures reliable
laboratory results.

3. Sample vs Specimen
ISO defines a sample as:“One or more
parts taken from a system to provide
information.”
"Specimen" is commonly used in labs,
especially for human samples.
In ISO documents: "Sample" = "Primary
sample".

4. Importance of Good Sample
Management
Critical for accurate, reliable diagnosis.
Impacts:Treatment decisions, Hospital
stay duration, Costs and efficiency
Prevents re-tests and incorrect
diagnoses.

5. Components of Sample Management
Requisition info
Urgent request handling
Collection, labeling, transport
Safety and biohazard practices
Sample evaluation, tracking
Storage and disposal

6. The Laboratory Handbook
Purpose: Guide for proper sample
handling.
Available at all collection points.
Contents include: Contacts, hours,
address;Test lists & urgent procedures;
Sample collection/transport details

7. Sample Collection Responsibilities
Collection often by non-lab staff
Lab ensures quality by: Providing
instructions, Supplying correct
containers, Checking sample labeling
and condition

8. Test Requisition Requirements
Essential info
Patient ID, test name
Date/time of collection
Sample source
Clinical info
Provider contact

9. Sample Collection Details
Consider: Patient preparation,
Identification method, Correct sample
type/container, Proper labeling and
special handling
Patient-collected samples need clear,
local-language instructions

10. Labeling & Collection Errors
Labels must include: Patient name, ID, test
requested, Date/time of collection,
Collector initials
Collection errors cause: Delays, redraws,
misdiagnosis, higher costs

11. Sample Processing & Rejection
Steps: Check labeling, quantity,
condition; Log sample info
Reject samples if: Unlabeled, wrong
container, Hemolysed, insufficient
volume, Label-form mismatch
Document and notify requester

12. Registering and Tracking Samples
Maintain sample log/register: ID number,
patient info, Collection/receipt time,Tests
requested
Manual or digital tracking
Aliquots must be traceable

13. Sample Storage and Retention
Policies should define:What to store and
for how long, Storage conditions and
organization
Long-term samples need tracking
systems
Avoid unnecessary freeze/thaw cycles

14. Sample Referral and Disposal
Referral: Use correct forms and
containers, Monitor turnaround and
results
Disposal: Follow safety and local
regulations, Disinfect before disposal

15. Sample Transport
Maintain sample integrity: Control
temperature, use proper containers
Adhere to transport regulations: ICAO,
IATA, national rules
Use triple packaging: Primary (sealed,
labeled), Secondary (watertight,
absorbent), Outer (protective box)

16. Managing Sample Transport
Train all personnel handling samples
Local transport: Use ice boxes, monitor
time
Air/road transport: Comply with
dangerous goods regulations
Categories: A: High risk (UN 2814/2900),
B: Lower risk (UN 3373)