Standard operating procedure

Specimen Handling & Transport Procedure

How [Organisation Name] positively identifies the patient, labels and packages histopathology, microbiology, cytology and other diagnostic specimens, transports them safely to the laboratory, and tracks every specimen until a result is returned and acted upon.

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What's inside

This standard operating procedure is fully drafted and structured, ready to brand and complete for your service. It covers:

  • 1. Purpose
  • 2. Scope
  • 3. Definitions and abbreviations
  • 4. Responsibilities
  • 5. Equipment and materials
  • 6. Procedure
  • 7. Transport and tracking
  • 8. Records
  • 9. Related documents
  • 10. Review and version control
  • 11. Disclaimer

Legislation & standards it maps to

  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 12 (Safe care and treatment)
  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 17 (Good governance)
  • Control of Substances Hazardous to Health Regulations 2002 (COSHH)
  • Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009 (and the European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR), UN3373 Category B)
  • Human Tissue Act 2004
  • Health and Safety at Work etc. Act 1974
  • Data Protection Act 2018 and UK General Data Protection Regulation

Who it applies to

All clinicians, nurses, healthcare assistants, phlebotomists, theatre and treatment-room staff, reception and administrative staff, and any locum, bank, agency or courier staff at [Organisation Name] who collect, label, handle, store, package, transport or track patient specimens, or who receive and act on laboratory results.

Glossary

Plain-English explanations of the technical terms and legislation used in this document.

ADR (European Agreement concerning the International Carriage of Dangerous Goods by Road)
The international agreement, applied in Great Britain through the Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009, that sets the rules for safely transporting hazardous goods such as specimens by road.
Blood-borne virus (BBV)
An infection such as hepatitis B, hepatitis C or HIV that can be passed on through blood.
Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009
The law that controls how dangerous goods, including diagnostic specimens, are classified, packaged and carried by road in Great Britain.
Care Quality Commission (CQC)
The independent regulator of health and social care services in England.
Chain of custody
The documented, unbroken record of who held a specimen and when, from collection through transport to receipt by the laboratory.
Contemporaneously
Written down at the time something happens, or as soon as possible afterwards, so the record is accurate and reliable.
Control of Substances Hazardous to Health Regulations 2002 (COSHH)
The law for safely managing chemicals and other hazardous substances at work, such as the formalin used to preserve specimens.
Cytology
The microscopic examination of individual cells or small cell clusters, for example from a smear, brushing or fine-needle aspirate.
Data Protection Act 2018
The UK law that sets the rules for how personal information, including health records, must be kept and used.
Decontamination
The combined process of cleaning, disinfecting and, where needed, sterilising equipment or surfaces so they are safe to reuse.
Despatch log
The record of every specimen sent, the date and time, the carrier, and confirmation that it was received and a result returned.
Failsafe (results failsafe)
A tracking system that makes sure every specimen sent leads to a result that is returned, reviewed and acted upon, so none is lost or missed.
Fixative
A chemical, most commonly formalin, used to preserve tissue specimens so they can be examined; it is a substance hazardous to health.
Formalin
A watery solution of formaldehyde used to preserve tissue specimens; it is harmful to health and must be handled with care.
Histopathology
The microscopic examination of tissue removed from a patient, usually preserved in formalin, to diagnose disease.
Human Tissue Act 2004
The law governing the consent for, and lawful storage and use of, human tissue and other bodily material.
Health and Safety at Work etc. Act 1974
The main UK law placing a general duty on employers to protect the health and safety of staff and others affected by their work.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
The regulations setting the fundamental standards that providers of regulated care must meet, enforced by the Care Quality Commission.
Infection prevention and control (IPC)
The measures used to stop infection spreading between patients, staff and visitors.
Microbiology
The examination of specimens such as swabs, urine or fluid to identify infection-causing organisms and their sensitivity to treatment.
Near miss
An event that could have caused harm but did not, by chance or because it was caught in time.
Pathogen
A micro-organism, such as a bacterium or virus, that can cause disease.
Patient identifiers
The minimum pieces of information that uniquely identify a patient, normally full name, date of birth and a unique record number.
Personal protective equipment (PPE)
Items such as gloves, aprons and eye protection worn to protect against harm or infection.
Primary receptacle
The sealed, leak-proof container that holds the specimen itself, forming the innermost layer of triple packaging.
Regulated activity
A type of care or treatment the law requires a provider to register with the regulator to deliver.
Registered Manager
The person registered with the regulator as responsible for the day-to-day running of a service.
Risk assessment
A structured check identifying what could cause harm and what is being done to prevent it.
Safety data sheet
A document from a chemical's supplier setting out its hazards and how to use, store and dispose of it safely.
Specimen
Any sample taken from a patient for diagnostic examination, such as a tissue biopsy, swab, urine, blood, fluid or cells.
Standard Operating Procedure (SOP)
A written, step-by-step instruction describing how a particular task must be carried out consistently and safely.
Triple packaging
The three-layer packaging principle - a leak-proof primary receptacle, leak-proof secondary packaging with absorbent material, and a rigid outer package - required for transporting biological specimens.
UK General Data Protection Regulation (UK GDPR)
The UK's main data-protection law governing how personal information is collected and used.
UN3373 (Biological substance, Category B)
The international classification and packaging standard for a diagnostic or clinical specimen that does not meet the higher-risk Category A criteria.

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