Sampling in Laboratories

Manual
(Laboratory Sample Management
Manual)

Issued by
Dr. Marwa Anwar
Consultant Clinical Pathologist
The Quality Manager of Damietta laboratories
Management
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 Contents
1 Purpose 3
2 Scope 3
3 Definitions 4
4 Roles and responsibilities 4
5 General sampling requirements 4
6 Test request completeness criteria 7
7 Special test request requirements 7
8 Acceptance and verification by the 8
laboratory
9 Rejection policy for test request 8
10 Sample identification 11
11 Sampling procedure by specimen type 12
12 Sample transportation 14
13 Sample reception 15
14 Sample storage and retention 16
15 Rejection criteria 16
16 Biosafety consideration 17
17 Quality assurance and monitoring 22
18 Reference 22

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1. Purpose
To define the standardized procedures for proper sampling, sample
collection, handling, transportation, reception, and storage to ensure
the accuracy, reliability, and integrity of patient test results in accordance
with ISO 15189 and national regulations.

2. Scope
This manual applies to all sample types processed in the laboratory,
including:
 Blood samples
 Urine samples
 Stool samples
 Swabs (throat, nasal, wound, etc.)
 Body fluids
 Histopathology/cytology samples
 Quality control samples

Laboratory samples

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3. Definitions
 Sample / Specimen: Material collected for laboratory testing.
 Pre-analytical phase: All processes from test request until sample
arrival in the laboratory.
 Sampling: The act of collecting a portion of material for testing.
 Transport conditions: Temperature, protection, and time required
to preserve sample integrity.

4. Roles & Responsibilities

4.1 Laboratory Director
 Approves sampling procedures and ensures compliance.
4.2 Quality Officer
 Ensures staff training, documentation, audits, and corrective
actions.
4.3 Laboratory Technologists/Nurses/Phlebotomists
 Perform sampling according to SOPs.
 Ensure proper identification, labeling, and handling.
4.4 Clinicians
 Ensure appropriate test requests and clinical information.

5. General Sampling Requirements

 Positive patient identification using two identifiers (name +
national ID/medical file number).
 Ensure informed consent where applicable.
 Use aseptic technique.
 Use proper containers, preservatives, anticoagulants.
 Label samples at the bedside, not later.
 Maintain chain of custody for legal/forensic samples.
 Follow biosafety precautions during all steps.

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5.1 Test Request Requirements (ISO 15189:2022 & GAHAR
Compliant)
A test request is the official document or electronic order used to
request laboratory investigations. It MUST contain all
information necessary to ensure correct identification, proper
sampling, accurate interpretation, and traceability.

5.1.1. Mandatory Patient Identification

Every test request must include at least two unique patient
identifiers:
 Full name (as in medical record)
 National ID number / hospital file number
 Date of birth

 Gender
(Any two of these are acceptable; more is preferred.)

5.1.2. Clinical & Administrative Information

The test request must clearly show:
 Ordering physician name, signature, and contact details
 Date and time of the test request
 Hospital/clinic/department name
 Priority of test: routine / urgent / stat / emergency

 Location of the patient: OPD / ER / ICU / ward number

5.1.3. Requested Tests

The request must specify:
 The exact test or panel required (e.g., CBC, LFT, CRP,
Viral markers)
 Special instructions (fasting / timed samples / double
sampling / repeat confirmation)
 For microbiology: suspected organism or infection (if
known)

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5.1.4. Clinical Information (Essential for Interpretation)
Clinical notes strongly support result interpretation. Requests
should include:
 Brief relevant clinical history
 Provisional/working diagnosis
 Symptoms or reason for testing
 Current medications
 Pregnancy status (if applicable)

 For infectious diseases: exposure risk, travel history

5.1.5. Sample Information

The request should describe the sample to be collected:
 Type of sample (blood, urine, swab, CSF, etc.)

 Collection site (e.g., left arm, wound site, cervical swab)

 Date and time of sampling (critical for stability)

 Required conditions (e.g., fasting, timed sample, post-

prandial)
 Volume required (if special or pediatric sampling)

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6. Test Request Completeness Criteria
The laboratory must only accept requests that include:
 Two patient identifiers
 Required clinical information
 Complete test name
 Ordering physician details
 Sample type + time

 Special preparation (if applicable)

Incomplete requests must be returned/clarified before
processing (except emergencies with documented justification).

7. Special Test Request Requirements

7.1 Transfusion / Blood Bank
 Blood group
 Previous transfusion history
 Previous pregnancies
 Allergy or reaction history
 Required blood component + urgency
7.2 Microbiology
 Clear clinical diagnosis or suspected infection
 Exposure history
 Antibiotic therapy (current/previous)
7.3 Histopathology/Cytology
 Exact anatomical site
 Type of procedure (biopsy, excision, FNAC)
 Surgeon’s name
 Fixative used
 Orientation/markings
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7.4 Toxicology
 Time of last drug intake
 Chain of custody (if legal sample)

8. Acceptance and Verification by the Laboratory

At sample reception, staff must verify:
 Request matches the sample label
 Sample is appropriate for

requested test
 All mandatory fields are
complete
 Any unclear requests must be
confirmed with the clinician
 Modifications or cancellations must be documented and
traceable

9. Rejection Policy for Test Requests

The laboratory shall only accept test requests that contain the
minimum essential information required for accurate patient
identification, proper sample handling, and valid interpretation
of results. Requests failing to meet these requirements must be
rejected or returned for clarification prior to sample
collection or processing.
9.1 Purpose of the Policy
To ensure:
 Patient safety and correct identification
 Proper documentation and traceability
 Reduction of pre-analytical errors

 Compliance with ISO 15189:2022 pre-examination

requirements

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9.2 Conditions Requiring Rejection of a Test Request
A test request shall be rejected if any of the following apply:
9.2.1 Missing or Inadequate Patient Identification
 Only one patient identifier provided
 No identifiers provided
 Illegible patient name or number
 Conflicting patient details on request vs. label

9.2.2 Missing Test Information

 No test specified
 Ambiguous or unclear test name
 Test abbreviation that may cause confusion
 Non-authorized test requested (not provided by the

laboratory)

9.2.3 Missing Clinical or Administrative Data

 Ordering physician’s name/signature not provided

 No date or time of request

 No location/ward information for inpatient samples
 Missing relevant clinical details for specialized tests (e.g.,
histopathology, microbiology, toxicology)

9.2.4 Illegible or Incomplete Request

 Request handwritten and unreadable
 Section(s) left blank that are essential for interpretation
 Electronic request missing mandatory fields due to system
error

9.2.5 Patient Preparation Not Followed

 Non-fasting sample when fasting is mandatory
 Incorrect sampling time for timed tests (e.g., cortisol,
OGTT)
 Improper instructions not followed (e.g., mid-stream urine,
clean-catch swabs)

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9.2.6 Unauthorized Test Requests
 Request not approved or outside clinician’s authorization
scope
 Test requires pre-authorization (e.g., genetic, esoteric tests)
but approval not obtained

9.3 When a Test Request May Be Accepted with Conditions

The laboratory may accept the request if clarification is obtained
before sampling or processing, such as:
 Missing minor information that can be verified by phone
 Physician provides clarification and documents change
 Correcting a spelling error without changing identity
All clarifications must be documented in the LIS or manual
log.

9.4 Emergency or Life-Threatening Situations

In urgent/emergency cases (ER, ICU, critical care):
 Sample/test requests may be provisionally accepted even if
incomplete
 Essential information must be confirmed as soon as

possible
 Deviations must be justified, documented, and approved
by senior staff

9.5 Documentation of Rejection

All rejected requests must be recorded, including:
 Patient name and identifiers
 Physician/unit
 Reason for rejection
 Action taken (e.g., returned for correction)
 Staff member responsible
 Time and date
This is essential for QMS monitoring and CAPA.

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9.6 Communication of Rejection
 Immediately notify the ordering physician or nursing unit
 Communicate politely and clearly
 Document all communications
 Ensure that patient care is not compromised during the
delay

9.7 Quality Monitoring

The laboratory shall:
 Track monthly rejection rates
 Identify trends (e.g., repeated errors by certain units)
 Implement corrective and preventive actions (training,
form redesign, LIS updates)
 Review policy annually

10. Responsibilities
 Ordering Physician: Completes request correctly
 Phlebotomist/Nurse: Checks request before sampling
 Lab Reception Staff: Verifies completeness and sample
suitability
 Quality Officer: Audits request completeness regularly
 Lab Director: Approves policies and updates

10. Sample Identification & Labeling

Each sample must have:
 Patient full name
 Unique ID (file number/ barcode)
 Date and time of collection
 Collector’s initials
 Sample type

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  Relevant clinical notes (if needed)
Unlabeled or mislabelled samples must be rejected according to the
rejection policy.

11. Sampling Procedures by Specimen Type

11.1 Blood Sampling
Materials: Tourniquet, needles, vacutainers, alcohol pads, gloves.
Procedure:
1. Verify patient identity.
2. Ensure fasting/ preparation as required (e.g., glucose).
3. Use correct order of draw:
1. Blood cultures
2. Citrate tube
3. Serum tube
4. Heparin
5. EDTA
6. Fluoride oxalate
4. Gently invert tubes as recommended.
5. Check for hemolysis or clotting.
6. Transport immediately.

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11.2 Urine Sampling
Types: Random, early morning, 24-hour
urine.
Random urine:
 Collect mid-stream in sterile
container.
 Minimum volume: 10–20 mL.
 Transport within 1 hour.
24-hour urine:
 Discard first morning urine.
 Collect all urine for 24 hours in provided container.
 Keep container refrigerated.

11.3 Stool Sampling

 Use clean, dry container.
 No urine mixing.
 For culture: transport within 30–60 minutes.
 For parasites: fresh sample preferred; avoid temperature extremes.

11.4 Swab Sampling

 Use sterile swabs with transport media.
 Throat: swab tonsillar area without touching tongue.
 Wound: collect from depth, not surface.
 Nasal/NP: insert swab back to nasopharynx gently.
 Send immediately.

11.5 Body Fluids (CSF, pleural, ascitic)

 Collected by clinician.
 Label each tube with sequence (e.g., 1–4 for CSF).
 Transport immediately at room temperature, except:
o Glucose/lactate on ice

o Microbiology sterile at room temperature

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11.6 Histopathology/Cytology Samples
 Biopsies: place in 10% neutral buffered formalin (10–20× tissue
volume).
 Cytology: use appropriate fixatives.
 Clearly label anatomical site.

12. Sample Transportation

 Use leak-proof containers & biosafety bags.
 Maintain recommended temperature (2–8°C / RT).
 Maximum allowable transport time documented for each sample
type.
 Maintain transport logs.

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 triple packaging of sample transportation

13. Sample Reception (Accessioning)

At laboratory reception:
 Check labeling against request.
 Verify sample volume and container suitability.
 Record arrival time and condition.
 Apply rejection criteria if necessary.
 Enter into LIS or manual registers.

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14. Sample Storage and Retention
 Chemistry samples: 2–8°C for 48–72 hours.
 Hematology EDTA: 24–48 hours.
 Microbiology: follow culture-specific timelines.
 Histopathology blocks: retained according to national policy.
 Ensure secure, monitored refrigerators/freezers.

15. Rejection Criteria

 Unlabeled or mismatched samples
 Insufficient volume
 Wrong container
 Hemolyzed/clotted blood (when unacceptable)
 Leaking samples
 Exceeded transport time/ improper temperature
Rejected samples must be documented, and clinician notified.

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16. Biosafety Considerations
. Biosafety Precautions in Sampling (Pre-analytical Phase)
Sampling (blood collection, swab collection, fluid aspiration, etc.)
is a high-risk activity because it involves direct contact with
patients and potentially infectious specimens. The following
precautions ensure the safety of staff, patients, and the
environment.

1. General Biosafety Principles

 Treat all samples as potentially infectious (Universal/Standard
Precautions).
 Perform sampling only by trained and competent personnel.
 Ensure the sampling area is well-ventilated, clean, and prepared
before patient arrival.
 Keep work surfaces disinfected with an approved disinfectant (e.g.,
70% alcohol, chlorine 0.1–0.5%).
 Avoid eating, drinking, touching face, or using mobile phones
during sampling.

2. Personal Protective Equipment (PPE)

Before sampling, staff must wear:
 Laboratory coat or
disposable gown
 Gloves (change between
each patient)
 Medical mask (surgical or
N95 depending on risk)
 Eye protection/face shield
(for splash-prone
procedures)
 Closed shoes
Do not reuse disposable
PPE.

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 3. Hand Hygiene
Hand hygiene must be performed:
 Before patient contact
 Before putting on gloves
 After removing gloves
 After accidental contamination
 After finishing sampling of each patient
Accepted methods:
 Alcohol-based hand rub (preferred)
 Soap and water when visibly soiled

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 4. Safe Sampling Practices
4.1 Patient Identification First
 Never touch patient or equipment before confirming identity.
 Avoid handling two patients’ samples at once.
4.2 Aseptic Technique
 Use single-use sterile needles, lancets, and swabs.
 Disinfect skin with 70% alcohol and allow to dry.
 Do not palpate disinfected area after cleaning unless wearing sterile
gloves.
4.3 Avoiding Contamination
 Open sterile equipment immediately before use.
 Do not place sterile equipment on unclean surfaces.
 Prevent cross-contamination between patients.

5. Sharps Safety
Sharps injuries are the most common hazard in sampling.
Precautions:
 Never recap needles.
 Use safety-engineered devices when available.
 Dispose of needles immediately in puncture-proof sharps
containers.
 Keep sharps containers at arm’s reach and below eye level.
 Do not overfill sharps containers (max ¾ capacity).

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 6. Sample Handling & Labeling Safety
 Label samples before leaving the patient’s side.
 Check that lids are tightly closed to avoid leakage.
 Use primary containers + secondary leak-proof biosafety bags.
 Avoid shaking blood tubes vigorously (reduces aerosol formation).
 Place ice packs appropriately for specimens requiring cooling (no
direct contact with tubes).

7. Environmental Controls
 Clean and disinfect sampling chair/bed between patients.
 Maintain proper ventilation in sampling areas.
 Use physical barriers for newborn or pediatric sampling when
possible.
 Keep biological spill kits accessible.

8. Waste Management
 Dispose of contaminated gauze,
cotton, swabs in biohazard
infectious waste bins.
 Separate non-infectious waste
from infectious waste.
 Use color-coded bags according
to national biosafety rules.

9. Spill Management
If a spill occurs during
sampling:
1. Stop the procedure
immediately.
2. Cover spill with paper towels.
3. Pour disinfectant (0.5% chlorine or equivalent) and wait 15–30
minutes.
4. Wipe from outside to inside.
5. Dispose of all materials as infectious waste.
6. Document the incident.

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 10. Management of Accidental Exposure
In case of:
 Needle-stick injury
 Splash to eyes/mucous membrane
 Broken tube or contact with blood
Actions:
1. Wash wound with running water—do NOT squeeze.
2. Report immediately to supervisor.
3. Complete exposure incident report.
4. Seek medical evaluation for post-exposure prophylaxis (PEP) if
indicated.
5. Follow the occupational health program.

11. Biosafety in Special Sampling Situations

11.1 Sampling from High-Risk Patients
(e.g., TB, COVID-19, Hepatitis B/C, HIV)
 Use enhanced PPE (N95, face shield).
 Perform sampling in a well-ventilated area or negative-pressure
room if aerosol-generating.

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  Do not allow crowding in the sampling area.
11.2 Microbiological Samples
 Avoid squeezing wounds or lesions to prevent aerosol formation.
 Keep swabs in transport medium immediately.
 Handle body fluid samples carefully to avoid splashing.
11.3 Pediatric Sampling
 Ensure child is properly secured to minimize movement.
 Use appropriate needle size to minimize injury to both staff and
patient.

12. Sample Transport Biosafety

 Use triple packaging:
o Primary container (sample tube)
o Secondary sealed biosafety bag
o External hard container
 Avoid hand-carrying tubes without bags.
 Courier must be trained in biosafety and spill response.

13. Documentation & Training

 All sampling staff must receive training on biosafety annually.
 Maintain records for PPE, spills, incidents, and exposures.
 Conduct periodic audits on sampling biosafety practices.

17. Quality Assurance & Monitoring

 Internal audits on sampling procedures
 Staff competency assessment
 Error tracking (pre-analytical errors)
 Corrective and preventive actions
 Periodic review of SOPs

18. References
 ISO 15189:2022 Medical Laboratories – Requirements for Quality
and Competence
 WHO Laboratory Quality Management System Handbook
 CLSI Guidelines (GP33, M29, M41, etc.)
 Egyptian MOH & GAHAR Laboratory Standards

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