Module 5 – Process Management:
Sample Management
Africa Centres for Disease Control and Prevention (Africa CDC)
Laboratory Quality Management Systems
One Health Approach
Learning Objectives
At the end of this module, participants will be able to:
• Describe a system for sample handling, including
collection, packaging, transport, receiving, storage,
retention and safe disposal;
• List down sample collection errors that could lead to
incorrect results;
• List contents that should be included in a laboratory
handbook.
• Establish criteria for sample acceptance and rejection.
Module 5_Process Mgt -Sample Management
Scenario
Your laboratory has performed PCR for influenza virus on
patient samples from ‘Clinic A’. Most of these results are
negative. The medical staff from ‘Clinic A’ tells you that their
patients present all the clinical signs of influenza.
What are you going to check?
What will you do?
TIME: 10 MIN
Module 5_Process Mgt -Sample Management
The Quality Management System
Organization Personnel Equipment
Purchasing & Process Information
Inventory Management Management
Documents & Nonconforming
Assessments
Records Event
Management
Continual Customer Facilities &
Improvement Focus Safety
Module 5_Process Mgt -Sample Management
Quality sample
The quality of a result of any laboratory examination is
only as good as the integrity of the sample received in
the laboratory. Module 5_Process Mgt -Sample Management
The importance of proper sample
management
Essential to
accurate
diagnosis
Influences Proper Influences
laboratory sample therapeutic
efficiency management decisions
Directly
affects
patient outcome
Module 5_Process Mgt -Sample Management
Components of Sample Management
Information Collection and
needed preservation
Laboratory
Transport to
Handbook, Labelling,
other
Policies & packaging and
laboratories
transport
Practices
Storage, Accessioning,
retention and processing and
disposal tracking
Module 5_Process Mgt -Sample Management
Laboratory Handbook
• Contains information needed by those who
collect samples
• Be available to all sample collection areas
• Be understood by all laboratory staff and other
users
• Be referenced in the quality manual
Module 5_Process Mgt -Sample Management
Laboratory Handbook Contents
• Name and address of laboratory • Complaint procedures
• Contact names and telephone • Advisory services
numbers • Instruction for completion of
• Hours of operation request form
• List of tests that can be ordered • Instruction for patient-collected
• Sample collection procedures sample
• Sample transport procedures • Sample accepting and rejection
• Expected turn around times (TAT) criteria
• How urgent requests are handled • Limitations of procedures
• Laboratory polices on protection
of personal information
Module 5_Process Mgt -Sample Management
The Laboratory’s Responsibilities
Provide appropriate
Provide sample
collection supplies, e.g.
collection information
containers, consumables
What – When - How
and request forms.
Assess all samples Define a good
(pre-examination) labeling system
Module 5_Process Mgt -Sample Management
Test Requisition
• Patient unique identification
• Gender, date of birth, location.
• Tests requested
• Time and date of sample collection
• Type of sample
• Source of sample, when appropriate
• Clinical data, where indicated
• Identity and contact information of
requester or authorized individual.
Module 5_Process Mgt -Sample Management
Collection Requirements
• Patient preparation
• Patient identification
• Type of sample required
• Type of container
needed
• Labeling
• Special handling
• Safety precautions
Module 5_Process Mgt -Sample Management
Sample collection requirements: PPE
Goggle Face Mask
Head + hair Eyes Nose + mouth Eyes + nose + mouth
Gown Apron Gloves Boots
Body Body Hands Feet
Module 5_Process Mgt -Sample Management
13
Provide sample Finger prick job aid
collection
information
(Example)
Module 5_Process Mgt -Sample Management
Labeling samples
• Patient’s name
• Date of birth/age
• Patient’s unique ID number
• Test ordered
• Time and date of collection
• Collector’s initials Use computer-generated
barcodes when possible.
Module 5_Process Mgt -Sample Management
Outcomes of improper sample collection
• Delays in reporting test results
• Unnecessary re-collection/re-tests
• Decreased customer satisfaction
• Increased costs
• Incorrect diagnosis / treatment
• Injury
• Death
• Litigation
Module 5_Process Mgt -Sample Management
Sample receipt procedures
Enforce sample Record on the
rejection criteria Verify register or log
• Unlabeled, miss-labeled • Completeness of test • Paper or computer
sample; request based register/log
• Broken or leaking • Appropriateness of • Include the
tube/container sample information on the
• Insufficient patients • Information on label request form.
information
• Hemolysed sample
(depending on test
requested)
• Sample collected in
wrong tube/container.
Module 5_Process Mgt -Sample Management
Sample Register or Log
Can be electronic or paper-based
A register should include:
o Date and time of collection
o Date and time of receipt
o Sample type
o Patient name
o Demographics as required
o Laboratory assigned
identification
o Tests to be performed
Module 5_Process Mgt -Sample Management
Actions for rejected
samples
• Inform the requester (or their
representative)
• Request another sample
• Record rejected samples
• Retain rejected sample based on
preset criteria
• Extraordinary circumstances may
require testing suboptimal samples
Module 5_Process Mgt -Sample Management
Sample Tracking
• Using sample tracking sheet/log
computer.
• Confirm receipt of samples,
include date and time
• Label samples appropriately; keep
with the test requisition until
Laboratory ID is assigned
• Track aliquots–traceable to the
original sample
Module 5_Process Mgt -Sample Management
Sample Tracking - Computer
Database entries include:
• Identification number
• Patient information
• Collection date and time
• Type of sample
• Tests to be performed
• Name of health care provider
• Location of patient, e.g., Ward, clinic, outpatient
• Diagnostic test results
• Time and date results are reported
Module 5_Process Mgt -Sample Management
Sample Handling
Handle all samples as if infectious!
Follow Standard and Transmission-based
Precautions.
Module 5_Process Mgt -Sample Management
Sample storage and retention
• Develop policy that defines:
• Samples to be stored
• Retention time
• Location
• Proper conditions
• Method of organizing samples
(indexing).
• Designate sample storage facilities
• Monitor storage conditions such as
temperature
Module 5_Process Mgt -Sample Management
Sample storage and retention
• Monitor stored samples, including
freeze/thaw cycles
• Maintain an organized, accessible
system
• Establish a schedule to check all stored
samples
• Establish tracking procedures
• Control of access to stored samples
Module 5_Process Mgt -Sample Management
Sample Referral
• Record:
• Samples referred
• Date of referral
• Time of referral
• Name of person referring test
• Test requested
• Referral laboratory
• Transporter/courier
Module 5_Process Mgt -Sample Management
Monitoring sample referral systems
• Monitor/track, and record:
• Turnaround time
• Results delivery (from
referral laboratory, to
requestor)
• Problems with referral
Module 5_Process Mgt -Sample Management
Sample Disposal
• Set policy for sample disposal
based on national and international
regulations.
• Follow established biosafety and
biosecurity guidelines/procedures.
• Note: Establish authorities for
sample disposal.
Module 5_Process Mgt -Sample Management
Sample Transport
• Maintain integrity of sample:
• Temperature
• Preservation of sample
• Special transport containers
• Time limitations
• Ensure biosafety and
biosecurity regulations are met
Module 5_Process Mgt -Sample Management
Sample transport regulations
These are developed by:
• National transport regulations
• ICAO/IATA transport regulations (air)
• Rail, road, and sea traffic agencies
• Postal services
• Private couriers
Module 5_Process Mgt -Sample Management
Mandatory
Compliance.
Violation leads to penalties.
Transport
Regulations Deal with accidents and spills
to reduce biohazards.
Safety: couriers, laboratory
staff, passengers.
Module 5_Process Mgt -Sample Management
Categories of Infectious Substances
Category A Category B Exempt
Infectious Biological Human/Animal
substances Substances specimens
Module 5_Process Mgt -Sample Management
Category A – Infectious Substances
• These are substances which are transported in a form that,
when exposure to them occurs to humans or animals, are
capable of causing:
• Permanent disability
• Life-threatening disease
• Fatal disease.
• Examples:
1. Bacillus anthracis (culture only)
2. Ebola virus
3. Monkeypox virus (culture only) Module 5_Process Mgt -Sample Management
Category B Biological Substances
• Biological substances that don’t meet the criteria for inclusion
in Category A
• Examples:
1. Streptococcus
2. Staphylococcus
3. Salmonella
Module 5_Process Mgt -Sample Management
Exempt Human/Animal Specimens
• Substances not known to contain infectious material
• Substances are unlikely to cause disease
• Examples:
o Neutralized or in-activated substances
o Environmental samples (Water or Food)
o Biopsies
o Dried blood spots
o Decontaminated medical or clinical waste
Module 5_Process Mgt -Sample Management
Transport of infectious substances
• It’s important to follow the applicable regulations when
transporting specimens.
• Packaging requirements differ for each category of
infectious substances
• Marking and labelling should also be in line with the
category of specimen to be transported.
• Ensure that staff are trained in proper transportation of
infectious substances.
Module 5_Process Mgt -Sample Management
Summary
• The laboratory is responsible for proper sample
management.
• The laboratory should provide information to all those
involved in sample collection.
• Establish and implement a system for tracking samples as
they move through the laboratory path of workflow.
• Establish and implement a policy for sample storage and
sample disposal
• Ensure that all transport requirements are met.
Module 5_Process Mgt -Sample Management
Key Messages
• The laboratory must have quality samples in order to
ensure accuracy and reliability of testing and confidence in
results.
• Sample management directly affects patient care and public
health outcomes.
• All samples should be treated as potentially infectious and
therefore must be handled following best biosafety and
biosecurity practices.
Module 5_Process Mgt -Sample Management
Exercise
Group 1: Develop sample acceptance and rejection criteria?
Group 2: What should be the main contents of the laboratory
handbook?
Group 3: Generate a list of possible errors in sample management
and how they could affect patient care.
Group 4: What problems/challenges do you frequently encounter
in sample management?
Module 5_Process Mgt -Sample Management
Thank you
Module 5_Process Mgt -Sample Management