appendix – policy template

TRANSPORT & DISPOSAL OF SPECIMEN CONTAINERS &

SPECIMENS POLICY

JANUARY 2009 Author: D. Johnston – Health and

Safety Manager (Acute) Responsible Director: Ian Reid – Director of HR Approved by: Health and Safety Forum Date approved: January 2009 Date for Review: January 2010 Version: GGC Version 1 Replaces previous version: [if applicable]

N/A

Specimen Transport of 29

TRANSPORT & DISPOSAL OF SPECIMEN CONTAINERS & SPECIMENS POLICY............................................................................................................................................. 1 1 INTRODUCTION ...................................................................................................... 3

1.1 Location of copies:.............................................................................................. 3 1.2 References:.......................................................................................................... 3 1.3 Review ................................................................................................................ 4 1.4 Communication and Implementation Plan.......................................................... 4 1.5 Monitoring .......................................................................................................... 4 1.6 Impact Assessment.............................................................................................. 4 1.7 Definitions........................................................................................................... 4

2 SCOPE ........................................................................................................................ 5 3 ROLES AND RESPONSIBILITIES .......................................................................... 6 4 FLOW CHART OF PROCESSES COVERED BY THIS POLICY.......................... 8 5 CONSUMABLES IDENTIFIED AND SOURCED: ................................................. 9 6 HEALTH & SAFETY .............................................................................................. 10

6.1 Courier .............................................................................................................. 10 6.2 General Public................................................................................................... 11 6.3 Receiving Laboratory........................................................................................ 11

7 DISTRIBUTION OF SPECIMEN CONTAINERS ................................................. 12 8 PNEUMATIC AIR TUBE SYSTEMS..................................................................... 12

8.1 Breakdown of pneumatic system...................................................................... 12 8.2 Spillages............................................................................................................ 12

9 TRANSPORT OF BIOLOGICAL MATERIAL AND/OR SPECIMENS BETWEEN LABORATORIES. ....................................................................................... 12 10 COURIERS........................................................................................................... 13

11.1 Model Rules for Laboratory Porters ................................................................ 13 11.2 Model Rules for Laboratory Couriers.............................................................. 14 11.3 Model Rules For Pathology Laboratory Couriers............................................. 15 11.4 Model Rules for Uplift of Specimens .............................................................. 16 11.5 MODEL RULES FOR VISITORS OR OTHERS DELIVERING DIRECTLY TO LABORATORIES............................................................................. 17

12 PACKAGING, LABELLING AND DESPATCH ............................................... 18 13 SPECIMEN INTEGRITY .................................................................................... 19 14 INCIDENT REPORTING .................................................................................... 19 15 REGULATORY REQUIREMENTS.................................................................... 20 16 CLASSIFICATION OF INFECTIOUS MATERIAL.......................................... 20 17 DISPOSAL OF WASTE SPECIMENS AND OTHER BIOLOGICAL MATERIALS.................................................................................................................... 20 18 Appendices............................................................................................................ 22

18.1 Appendix 1 - Pathology .................................................................................... 22


1 INTRODUCTION

This policy describes the minimum standard to which operators should aim when transporting specimens within and between hospital premises, to and from community sources and to outside (non NHSGG&C) agencies. It is recognized that the large and varied area and practices covered cannot be served by a prescriptive policy document. The policy, therefore, does not prescribe the mechanisms or precise means of transport of specimens in the various areas and activities covered. It seeks, rather, to encourage local managers to design and document their own safe working procedures, reminds them of their statutory legal obligation to assess and document any risk involved and audit/police the success of their standard operating procedures. Several sets of “Model Rules” are provided in this document and should be used where general staff functions are discharged in a manner that is not determined by geographic peculiarities. The Policy aims to provide a uniform structure and define standards, for all of NHSGG&C, to transport and receive biological specimens in a legally compliant and safe manner.

1.1 Location of copies: Placement at each laboratory reception area and at each specimen collection point. Available for each manager/quality officer involved with specimen collection/transfer/disposal. Procurement/Laboratories Directorate Executive Officers/ Transport Managers. Copies may be downloaded through StaffNet.

1.2 References: 1. CPA standards C5 and E4 2. Transport of Infectious Substances, 2004, Department of Communicable

Disease, Surveillance and Response, World Health Organisation. 3. Chemicals (Hazard Information and Packaging for Supply) Regulations

2002 as amended 4. A Code of Practice for the Prevention of Infection in Clinical Laboratories –

Howie report 1979 – Appendix 2 Model Rules for Laboratory Porters and Messengers, Prevention of Infection

5. A Code of Practice for the Prevention of Infection in Clinical Laboratories – Howie Report 1979 Appendix 2 Model Rules for Laboratory

6. The Approved List of Biological Agents, for the purposes of Control of Substances Hazardous to Health Regulations 2002, 2004

7. Safe Working and the Prevention of Infection in Clinical Laboratories and similar facilities, Health Services Advisory Committee, 2003

8. Safe Working and the Prevention of Infection in the Mortuary and Post Mortem Room, Health Services Advisory Committee, 2003


9. Biological Agents: Managing the Risks in Laboratories and Healthcare Premises, Advisory Committee on Dangerous Pathogens, 2005

10. Management of Health and Safety at Work Regulations 1999 11. Control of Substances Hazardous to Health Regulations 2002 (as

amended)

1.3 Review This policy will be reviewed at least every two years or when circumstances dictate

1.4 Communication and Implementation Plan The following will be included for awareness of the policy and dissemination to staff: Procurement, Ward Managers, Laboratory Managers, Portering and Domestic Services, Quality Managers, Directorate Executive Managers, Human Resources (Health and Safety Advisers.) Transport Departments

1.5 Monitoring Progress and implementation of the policy will be subject to a rolling audit procedure. Health and Safety Advisers will be responsible for administration and execution of audits. At least one full audit report will be presented to Laboratory Annual Management Review meetings.

1.6 Impact Assessment To be completed upon agreement of Policy, prior to final distribution.

1.7 Definitions Category A Pathogens: the higher risk infectious micro-organisms, defined as “an infectious substance, which is transported in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals”. Any specimen that might reasonably be considered to harbour such organisms should also be treated as Category A


W.H.O. Risk groups classifications may found at: www.who.int/csr/resources/publications/WHO_CDS_LYO_2004_9/En/ Infectious substances including those containing new or emerging pathogens, which do not appear in the lists defined above, but that meet the same criteria as category A pathogens, should be treated as Category A pathogens. These must be transported as UN2814 (Infectious substance affecting humans) and labeled as “Infectious substance affecting humans” Pack according to Packing Instructions P620

THE DEPARTMENT OF HEALTH HAS PROHIBITED SENDING OF ANY CATEGORY A SUBSTANCES BY POST.

Category B Pathogens: any micro-organism that does not meet the criteria for category A. It includes human material such as, but not limited to, excreta, secreta, blood and its components, tissue and tissue fluids, and body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment or prevention. These are assigned to UN3373 and must bear the marking “Biological Substance – Category B” and be packed to Packing Instructions P650 Substances not subject to the regulations:

Non-pathogenic organisms Blood and blood components for transfusion or transplant and

tissues or organs for use in transplants Samples (non-human/animal derived) where there is only a low

probability of infectious substances being present Decontaminated clinical or medical waste

2 SCOPE

This policy describes the requirements for methods of transport of specimens and containers to and from laboratories within the NHSGG&C area and to laboratories outwith that area. Specifications according to various disciplines may be accessed in the Appendices as required

Deliberate Exclusions:

1. Techniques of specimen collection: physical collection of specimens, from patients, must be determined on geographical, individual and clinical basis to suit the circumstances of collection. It is therefore outwith the scope of this policy to prescribe methods of collecting specimens.

2. Biological material, e.g. organs or tissue (solid or liquid), and their products, that are harvested for therapeutic purposes, from either cadaveric or living donors, require special modes of preservation and transport and are therefore not included in this policy.


http://www.who.int/csr/resources/publications/WHO_CDS_LYO_2004_9/En/

3. Storage and transport of cadavers is not included in this policy. 4. Transfer of specimens, in a working situation and wholly within laboratory

premises, is excluded. 5. Couriers who are contracted by NHSGG&C, who stipulate special

conditions for specimen uplift and transfer, and who provide all consumables required, are excluded from this policy.

6. Cultures prepared for the intentional generation of pathogens may not be transported as diagnostic specimens. Special instructions (P620) apply to these materials.

3 ROLES AND RESPONSIBILITIES

Responsibility: All those involved in specimen collection are responsible for ensuring the safe transport of the specimens to their intended destination. All health care workers who handle or transfer specimens are responsible for doing so in a safe, appropriate and confidential manner. Procedures designed during the process, for transfer of specimens, must be risk assessed formally by appropriate managers and recorded. The policy document has been designed and edited by groups from the Laboratory Directorate, Infection Control, Domestic and Portering Services and Transport Services. Applicability: The policy applies to collection of specimens within ward or community clinical areas, their transport to laboratories, and their final disposal after analysis. While it is expected that everyone dealing with specimens will observe the policy it is also recognised that, from time to time, circumstances or geographic restrictions or peculiarities may make certain parts of the policy unworkable. There may also be methods of transfer of specimens, e.g. involving cryogenic materials, which will require special containers, heightened levels of difficulty or transfer conditions. Senior managers, in conjunction with H&S Officers and advisers must assess risk of alternative procedures and make suitable, sufficient and safe adjustments to the policy at a local level. Such alterations must be recorded and lodged with the Clinical Director for Laboratories, with Quality Managers for the areas concerned, with the senior Site Facilities Manager for the area and, if relevant, with the senior Manager of Transport Services. Traceability: On occasion, where exceptionally invasive or uncomfortable techniques have been used, e.g. biopsy specimens, or where there is a legal requirement for “chain of custody” a system of traceability is required. This will involve a detailed method of tracking the history of specimen transfer from place to place and from person to person. Most of the manual transfer of specimens within Healthcare premises and to and from delivery/collection points is expected to be performed by porters who are under direct control of Facilities Managers. The organisation


and delivery of the means of delivering this function will therefore be the responsibility of the (Lead) Site Facilities Managers who will co-operate with Transport Managers serving their areas. The process may be carried out using either paper or electronic means or a combination of both and must take cognisance of the principal consignor, transfer and recipient parties concerned. The success of such an operating procedure is dependent on the inclusion and co-operation of all of these parties.


4 FLOW CHART OF PROCESSES COVERED BY THIS POLICY

Choose as appropriate

Portering Driver*/Courier Pneumatic Air

Tube System

Specimen Collection from patient

Specimen collection (e.g. Hospital Ward/G.P. Surgery)

Clinical Site

Disposal External Reference Laboratory

*If taxis are used: Full identification details, i.e., taxi driver’s name, licence number, company name, and vehicle registration must be recorded and retained by the consignor. These data must be obtained and recorded before the specimen is relinquished for transport.

LABORATORY


5 CONSUMABLES IDENTIFIED AND SOURCED: CEDAR numbers vary according to site of request: contact helpdesk at local supplies

Department for CEDAR numbers and codes. A level of standardisation may be required. At present different request forms and different

requesting techniques are used. The items and suppliers described here may alter, from time to time, according to general service

requirements. Item description: Manufacturer’s Part Number Function

HISS type request form (blank and printed on requesting site)

Not Required Computer generated requests

Twin pocket polythene bag “Re-sealable Specimen Bags)

Henley’s Medical HB-55

For HISS form and tubes

Request form integral with sealable bag

Jones & Brooks Biochemistry, Haematology

Microbiology/Virology Pathology: Supplier to be

contacted with specifications once unitary forms have

been agreed

For handwritten requests

Opaque blue polythene bag for (manual) ward to lab transfer

Fast-Aid Products Ltd B402839BU

Ward to lab portering with

multiple collections on multiple floors

Box for courier/van transport or soft sided pack Gusset Style Envopak

Daniels, Industrial Estate, Kidlington, Oxon. OX5 1JQ

Part No.: DD851 Part number required

1G412, 457x356x102 mm

GP to Lab transfers

Envopak pouch, flat style, long edge zip

1F7 483 x 381mm Alternative GP to lab or ward

to lab transfers Griff Bin

Sharp Safes Autoclave boxes

Griffiths and Neilson. Stane Street

Slinfold Horsham

West Sussex RH13 OTW

UK

Disposal of analysed

specimens

Shelved trolley at each specimen collection/delivery point.

May also be used for ward to lab (manual) transfers.

Mail Room Trolley HC Slingsby PLC, Otley

Road, Baildon, Shipley,BD17 7LW

For bulk transfer of specimens

(Van to Lab, Ward to Lab)

Pathopak (for GPO) DGP Pathoshield 4, [email protected]

www.dgpgroup.com

For sending by GPO or non NHS courier.


mailto:[email protected]

6 HEALTH & SAFETY Specimens must be transported in such a way as to ensure the safety of the courier, the general public and the receiving laboratory.

6.1 Courier Primary and secondary specimen containers are ordered through General Stores/Supplies Department using the CEDAR system. Specimens must be packed for transport in a way that prevents cross contamination of forms or other specimens when a specimen leaks. As far as is possible, all specimens should be kept within a leakproof container and be separate to their own request form. Reasonable care should be taken that the specimen is closed properly, that its primary transport container is sealed properly and can contain any leaks or spills, and that all documentation accompanying the specimen is clean and unlikely to be contaminated. These principles should also be applied to secondary and tertiary containers that may be required for onward transport. Do not put more than one set of patient specimens in one bag. ENVOPAK sealable bags are used to transfer emergency specimens (http://www.envopak.com/) on occasions when use of taxis or other public service transport cannot be avoided.

Model Rules for Laboratory Couriers are detailed in Management Instructions and are published as a separate controlled document and within this document (Refer to local document control system). Instructions in case of accident or incident, where the Laboratory Courier is unable to communicate, are detailed in Management Instructions and within this document. (Refer to local document control system) Instructions for use of Pneumatic Air Tube Systems is detailed in Management Instructions (Refer to local document control system)


http://www.envopak.com/

Pay especial note to restrictions in type of specimen (governed by pathology or analysis) that can be transferred using this type of system. Note that local circumstances will dictate precise use of these tools. Model Rules for porters are detailed in Management Instructions and within this document. (Refer to local document control system)

6.2 General Public Members of the General Public are issued with guidelines on the collection and transport of specimens as required. This includes the use of urine collection bottles containing acid preservatives. Safety Data Sheets should be issued with each specimen container. These should include instructions, for patients and others, on how to collect a 24h specimen of urine and how to use the bottles. Patients should be encouraged to use Hospital or Health Centre facilities for transport of specimens to laboratories. They should be discouraged from bringing specimens to the laboratories by their own means of transport. Model Rules for visitors to the laboratory are detailed in a separate controlled document and at the end of this document. (Refer to local document control system)

6.3 Receiving Laboratory Clinical laboratories’ reception staff are trained in the proper method of opening the sealed specimen transport boxes. Boxes contain wadding, which is changed when the box is cleaned and/or in the event of a spillage. Specimen containers that are visibly soiled will be dealt with as per departmental procedure. The source of origin will be notified should action be required. Biohazard Spill kits are located within laboratory reception areas. All staff are trained to use these kits. Laboratory staff will not clean spills outside of the laboratory area unless a formal agreement has been made for them to do so. Model Rules for Laboratory Reception Staff are detailed in a separate controlled document . These rules may vary according to local conditions and requirements. (Refer to local document control system)


7 DISTRIBUTION OF SPECIMEN CONTAINERS Specimen Containers: Specimen containers should be ordered via general stores and used for transport of specimens to the laboratory. The outer containers should be labelled with originating source. Specimen Uplift: Collection times and points must be agreed at local managerial level and registered with the local Quality Managers, the Director of transport, Director and local manager of laboratories. It should be understood that all times agreed are dependent on traffic and weather conditions

8 PNEUMATIC AIR TUBE SYSTEMS All specimens should be placed in sealed specimen bags and placed in a pneumatic tube carrier (pod) as described in local policy.

8.1 Breakdown of pneumatic system In the event of breakdown contact the appropriate persons as described by local policy and with reference to the installation company.

8.2 Spillages If a spillage is suspected in a carrier pod do not open the pod unless within the laboratory environment and under the instruction of a qualified and experienced person.

9 TRANSPORT OF BIOLOGICAL MATERIAL AND/OR SPECIMENS BETWEEN LABORATORIES. Royal Mail Transport of W.H.O. Risk group 3 and 4 specimens/materials, by public mail systems, is prohibited. These materials must be transported, following appropriate packaging, by specialist courier/transport companies. W.H.O. Risk Group 1 and 2 materials/specimens can be sent by public postal systems provided they are wrapped properly and are labelled according to the instructions (following) in this policy. Specialist couriers may have different requirements and a standard operating procedure, for making materials/specimens safe for transport, should be agreed with the courier before sending. W.H.O. Risk groups classifications may found at:


www.who.int/csr/resources/publications/WHO_CDS_LYO_2004_9/En/

10 COURIERS Where possible, use couriers already contracted to NHSGG&C. These courier companies will help with advice about methods and materials for packaging. The courier also has the right to refuse collection of materials considered unsafe even if properly packaged. 11 MODEL RULES These may differ by location. Local rules will not form part of the policy but will have to be agreed both at local level and with partnership input.

11.1 Model Rules for Laboratory Porters The Model Rules, given below, are published as a separate controlled document which is displayed within the Porters Office, Laboratory Reception and in each department of the laboratory. (Refer to local document control system)

1. Carry all specimens in opaque plastic bags (blue bags are sourced in the preceding table) or the boxes provided - large boxes for ward collection, small boxes for collection of emergency specimens. Pathology specimens are transported directly to the Pathology Department in specialised, sealed boxes. Theatre and Day Surgery Unit boxes must be transported flat on the trolley provided. At the Pathology Department, the boxes are exchanged on a one for one basis.

Sealed boxes must not be opened by unauthorised staff

2. Any cuts or grazes on your hands should be covered with a waterproof dressing at all times

3. Touch specimens as little as possible

4. If you do touch any specimens wash your hands as soon as possible afterwards

5. Wash your hands often - before meal breaks, and at the end of a spell of duty

6. If a specimen leaks into the box, tell laboratory reception staff who will take steps to make the spillage safe

7. If you drop or break a specimen, do not touch it or clear up the mess. Quarantine the area and call for assistance in having the spillage cleaned by people trained for that task.

8. Handle specimens carefully at all times

9. Never eat, drink or smoke when carrying specimens, or when in the laboratory


http://www.who.int/csr/resources/publications/WHO_CDS_LYO_2004_9/En/

10. If you cut yourself or have an accident, however small, tell your line manager and if required go to the Accident & Emergency Department. Also tell your Health & Safety Officer and see that an incident report is completed.

11.2 Model Rules for Laboratory Couriers The Model Rules, given below, are published as a separate controlled document which is displayed within the Transport Office, Laboratory Van, Laboratory Reception and in each department of the laboratory. (Refer to local document control system)

1. In the event of an accident or incident, telephone the hospital

switchboard who will contact a laboratory representative for advice.

2. If you have a breakdown or accident do not let anyone touch the specimens unless they are an authorised hospital employee

3. Always ensure specimens are not subjected to extreme heat, cold or left in

direct sunlight. Report all incidents that may affect the quality of the specimens or the safety of personnel to laboratory managers, who will liaise with the sample source and destination

4. Uplift sufficient empty Specimen Transport containers (tertiary) for each

run from the laboratory

5. The transport box should be sealed before carrying. If required, leave a replacement empty box for the next collection/delivery.

6. Deliver sealed boxes to laboratory reception

7. Carry gloves and some absorbent wadding (cotton wool or wypalls) in

your vehicle. The standard operating procedure, for dealing with leaking specimens, should be followed.

8. Any cuts or grazes on your hands should be covered with a waterproof

dressing at all times

9. Do NOT touch specimens at any time


11. Never eat, drink or smoke when carrying specimens, or when in the

laboratory


12. If you cut yourself or have an accident, however small, tell your line

manager and if required go to the Accident & Emergency Department. Also tell the Health & Safety Officer and see that an incident report is completed

11.3 Model Rules For Pathology Laboratory Couriers

1. The Model Rules, given below, are published as a separate controlled document which is displayed within the Transport Office, Pathology Laboratory Van and Pathology Reception. (Refer to local document control system)

2. In the event of an accident or incident, vacate vehicle, cordon off

immediate area, telephone the Hospital switchboard who will contact a senior member of the Pathology Department for advice.

3. If you have a breakdown or accident do not let anyone touch the

specimens unless they are an authorised hospital employee

4. Always ensure specimens are not subjected to extreme heat, cold or left in direct sunlight. Report all incidents that may affect the quality of the specimens or the safety of personnel to the laboratory representative, who will liaise with the sample source and destination

5. Uplift sufficient empty specimen boxes for each run from the laboratory

6. Boxes are sealed at source using plastic ties, uplift box and leave empty,

replacement box

7. Deliver sealed boxes to Pathology reception

8. Carry gloves and some absorbent wadding (cotton wool or wypalls) in your vehicle. The standard operating procedure, for dealing with leaking specimens, should be followed.

9. Any cuts or grazes on your hands should be covered with a waterproof

dressing at all times

10. Do NOT touch specimens at any time



12. Never eat, drink or smoke when carrying specimens, within hospital transport or when in the laboratory

13. If you cut yourself or have an accident, however small, tell your line

manager and if required go to the Accident & Emergency Department. Also tell the Health & Safety Officer and see that an incident report is completed

11.4 Model Rules for Uplift of Specimens The Model Rules, given below, are published as a separate controlled document which is displayed within each specimen collection area, at porters’ stations, within laboratory reception areas and in the Transport Manager’s office. (Refer to local document control system)

1. Patient confidentiality, privacy and dignity must be maintained at all times. 2. Specimens must be kept in a stable and suitable manner especially

having regard to requirements of temperature and exposure to bright light.

3. Equipment and materials must be on hand, readily, to deal with breakage of or spillage from specimen containers.

4. Specimen collection points must be easily recognisable and, as far as is

reasonably possible, must be in a constant position within the area.

5. Design of the collection point, and its position, will be the responsibility of the area manager but must be agreed with those, e.g. porters, couriers, etc., who will collect specimens from it.

6. A timetable for collection of specimens should be agreed with those

responsible for collecting the specimens and should be published adjacent to the specimen collection point.

7. The specimen collection point must be sited so as not to be accessible to

casual passers by or other unauthorised persons.

8. Staff in charge of collection points are encouraged to demand documentary identification details from those coming to collect specimens at the collection point.

9. All materials kept at the collection point must be stored in a way that does

not allow casual observation of identification or clinical details on individual specimens.


10. Persons leaving specimens at collection points must ensure, by careful visual examination, that the specimens containers, wrappers, bags and request forms are clean and free of visible contamination.

11. Persons collecting specimens should examine them to ensure that the

specimens containers, wrappers, bags and request forms are clean and free of visible contamination. The specimen must not be uplifted from the specimen collection point if there is any obvious contamination or soiling on it or its associated wrapper and documentation.

12. Any deviation from any of these rules should be reported, immediately, to

the manager in charge of the area in which the collection point is placed.

11.5 MODEL RULES FOR VISITORS OR OTHERS DELIVERING DIRECTLY TO LABORATORIES

All visitors should report to reception on arrival

Engineers or workers from out-with the department must obtain approval

from the section manager before commencing work

Children are not allowed in the laboratory working area and must be supervised closely at all times if present in other areas

All visitors should:

o Avoid eating, drinking, chewing, smoking or running in any

laboratory working area

o Wear appropriate protective clothing in the laboratory working area but not in the common room or hospital dining areas

o Avoid hanging protective clothing beside coats, jackets etc. (pegs

are provided for protective clothing)

o Wash hands after removing protective clothing or handling specimens.

o Keep all areas clean and uncluttered

o Not obstruct exits or floors

o Remain under supervision. If required to do so a senior member of

laboratory staff and/or security should be informed when the visitor enters and leaves the work area


o Report any incidents including any personal injury to the Health &

Safety Officer and documented (IR1 form)

o Refer to the local fire safety procedure

12 PACKAGING, LABELLING AND DESPATCH All specimen boxes have an identifying yellow label containing the biohazard symbol: -

and stating: -

BIOHAZARD PATHOLOGICAL SPECIMENS

IN THE EVENT OF AN

ACCIDENT OR INCIDENT PLEASE CONTACT: -

Local Contact details to be inserted.

Instructions in case of accident or incident are published as a separate controlled document. (Refer to local document control system) Leakproof secure containers (Part number/Cedar Number supplied) must be used when specimens are transported outside of hospital bounds. All hazardous specimen containers are identified with appropriate hazard warning labels e.g. corrosive symbol for acid.

24-hour urine bottles are transported in individual carrier boxes containing sufficient packaging material to soak up any liquid spillage. Formalin bottles are transported in leak proof containers capable of containing the effects of a spillage.


COSHH Risk assessments are available for all hazardous specimen container materials eg - 10% Buffered Formaldehyde

Specimens in Formaldehyde EXEMPT HUMAN SPECIMENS

PI 650

The specimen containers and specimens are transported via the appropriate Hospital Transport Department A more detailed description of requirements for specimens preserved in Formaldehyde, especially concerning Pathology Departmental requirements, is given in Appendix 1.

13 SPECIMEN INTEGRITY Specimens are transported to the laboratory with minimum delay. All specimens are kept out of direct sunlight to preserve sample integrity.

14 INCIDENT REPORTING Incidents and accidents are reported to the appropriate Line Manager, and the Health & Safety department, if an IR1 form is required.


Incidents and accidents involving the Pathology van are also reported to the Pathology Department. All incidents and accidents are investigated.

15 REGULATORY REQUIREMENTS Specimen transport complies with the Transport of Infectious Substances, 2004, Department of Communicable Disease, Surveillance and Response, World Health Organisation. Specimen containers are packaged to comply with Chemicals (Hazard Information and Packaging for Supply) Regulations 2002,as amended

16 CLASSIFICATION OF INFECTIOUS MATERIAL The classification UN3373 “Biological Specimens – Category B” covers all specimens, which are sent to laboratories except those which might contain Group 4 biological agents. As such they must be packaged under packaging instructions P650. This requires a leak proof primary receptacle (universal, blood vial, etc) and leak proof secondary packaging such as a self-sealing plastic bag. Liquid specimens must have absorbent material between the primary and secondary containers sufficient to absorb the entire contents. The classification UN3373 is based on the small quantity of infectious material likely to be present in a diagnostic specimen. Bacterial cultures sent from one laboratory to another contain much more hazardous material and should be classified as UN2814 “Infectious substance affecting humans” and must be packaged under packaging instructions P620. Packaging instructions P650 and P620 are outlined in annex 1 and annex 2 Transport of Infectious Substances, 2004, Department of Communicable Disease, Surveillance and Response, World Health Organisation. Note additional requirement for labelling of specimens in formaldehyde. (Section 12 above and Appendix 1 below.)

17 DISPOSAL OF WASTE SPECIMENS AND OTHER BIOLOGICAL MATERIALS A local standard operating procedure for disposal of waste specimens should be agreed between laboratory managers, theatre managers and the local Director of Facilities. Essential requirements are:

1. All materials should be kept secure until disposal. 2. Weight and size restrictions, as required by Manual Handling Operations

Regulations, must be obeyed.


http://www.who.int/csr/resources/publications/biosafety/en/WHO_CDS_CSR_LYO_2004_9Final.pdf



http://www.hse.gov.uk/pubns/indg350.pdf




3. All waste material must be packaged in water and gas tight packaging 4. All marks that might lead to identification of patients providing the

specimens/tissue must be obliterated in the disposal procedure. The disposal agents may have to take responsibility for this and provide satisfactory evidence of the process.

5. All waste material must be destroyed in such a way that any residue, particularly if going to landfill, is microbiologically sterile and chemically stable as befits disposal by landfill.

6. Any material that is not suitable for incineration should be clearly marked as such.


18 Appendices

18.1 Appendix 1 - Pathology

Transportation of Laboratory (Pathology) Specimens

Because of the distinction of risks between infectious substances and diagnostic specimens, there are variations to the packaging, labelling and documentation requirements. The packaging requirements are determined by the United Nations (UN) and are contained in ICAO (International Civil Aviation Authority) and IATA (International Air Transport Authority) regulations in the form of Packaging Instructions PI 602 and PI 650

There are 4 steps involved in the transportation of laboratory specimens 1. Classification & Categorisation 2. Packaging 3. Labelling 4. Transporting

1) Classification Infectious substances are classified according to their risk/danger to humans. They

come under Class 6 – (Toxic Poisonous and Infectious substances), Division sub class 6.2 (Infectious

substance) Categorisation Within Division 6.2, infectious substances are categorised as follows - Category A – an infectious substance which is transported in a form that, when

exposure to it occurs, is capable of causing permanent disability, life threatening or fatal disease to humans or animals Assigned shipping classification – Humans UN 2814. Animals only Assigned classification – UN 2900 Packaging instruction – P620 Hazard Group Classification i.e. - UN 6 (infectious)

Category B – any infectious substance that does not meet the criteria for inclusion in Category A Assigned shipping classification – UN 3373. Packaging instruction – P650 Hazard Group Classification i.e. - UN 6 (infectious) The only exception to this is CULTURES, which are assigned UN 2814 or 2900


2) Packaging The Packaging Instruction is determined depending on the infectious categorisation or

risk category as follows Category A substances - Packaging Instruction PI 620 Packaging should be UN type approved and consist of –

1. Leak proof primary receptacle either glass, metal or plastic 2. Leak proof secondary receptacle either metal or plastic – If screw caps are used,

they should be secured by positive means e.g. tape 3. Other than solid infectious substances, absorbent material in sufficient quantity to

absorb the entire contents placed between the primary receptacle and the secondary packaging

4. An itemised list of contents shall be enclosed between the secondary packaging and the outer packaging

5. Specimens of unknown infectious risk but suspected of meeting the criteria for inclusion in Category A, the words ( suspected Category A infectious substance) must be shown on the outer packaging

Empty containers showing signs of contamination must be destroyed rather than being returned to the original consignor.

Category B substances – Packaging Instruction PI 650 The packaging shall consist of 3 components –

1. A primary receptacle of suitable material appropriate to the specimen 2. A secondary packaging to contain the primary packaging in such a way that under

normal handling the primary packaging will not break or leak. Absorbent material should be placed between the Primary and the Secondary as a precaution to leaking fluid.

3. An outer packaging to contain the secondary packaging and suitable cushioning material to secure the secondary packaging. This should not be compromised by breakage or leakage of the primary packaging

Formaldehyde content - Packaging Instruction PI 650 The packaging for pathological specimens containing formaldehyde is as for Category

B substances Refrigerants (dry ice) - Packaging Instruction PI 904 When specimens are being transported in dry ice (solid carbon dioxide) it is mandatory that the packaging is designed and constructed to permit the release of carbon dioxide gas and prevent a build up of pressure that could rupture the package. The dry ice must be placed outside the secondary receptacle. If wet ice is used, all packaging must be leak proof.


If dry ice is used for infectious substances, the details must appear on the packaging, the word “MISCELLANEOUS” and Hazard Group classification UN 9 (Dry Ice) 3) Labelling Basically when specimens are being transported, the following information should be evident on the outside of the transport container (the tertiary packaging)

1. United Nations risk of infection shipping classification (the level of risk) – UN number

2. How the specimen was packaged – Packaging Instruction Classification – PI number

3. Identification of the hazard type – UN Hazard Class number 4. Orientation Arrows – Keep specimen upright – not required if fluid is less that

120ml and absorbent material will completely absorb the liquid. Class 6 infectious substances – 50ml (January 2007 edition of RID) page 59

1. Example

Pathological Sample in Formaldehyde

1 1 1 1 1 1 1 1 EXEMPT HUMAN

PI 650


Additional Labelling common to all P.I.

5) Sender address 6) Receiver address 7) Contact details (telephone number of sender) 8) Biological Hazard Sticker

4) Transporting There are several reasons why specimens require to be transported –

Doctor’s surgery to laboratory From hospital to diagnostic laboratory From one laboratory to another The principles for safe transport are the same as for air or international transport – the material should not have any possibility of escaping from the package under normal conditions of transport

General Principles Specimens should be packaged appropriately according to their risk Where indicated, specimens should be transported upright secure Specimens should be secured within a watertight and leak proof transport box

with a “secure tag” type lid Specimen boxes should be secured in a suitable dedicated laboratory vehicle Each transport box should be labelled appropriately consistent with its

contents Specimen data, forms and identification data should accompany each transport

box (audit sheet) A Spill Kit containing appropriate materials should be carried in each

laboratory transport vehicle (not in the specimen compartment) Laboratory transport vehicle drivers should carry a mobile phone and be fully

aware of all SOPs relating to their activity

Transport planning

The efficient transport and transfer of specimens and infectious material depends upon good communications and a partnership between all parties There are 3 parties involved in specimen transportation and all have a specific responsibility to carry out the transport effort


The sender Make advance arrangements with receiver where appropriate Make advance arrangements with courier (if not a routine service) Prepare appropriate documentation (tracker sheets) Notify receiver if appropriate of expected time of arrival

The carrier

Provide sender with shipping documentation if appropriate (private courier)

Is familiar with the contents of the shipment (external markings on packages)

Is familiar with SOPs appropriate to the task ( full set of instructions relative to specimen transportation)

Carries a Spill Kit and is trained in its use Notifies sender of any problems with specimens or delays in delivery

The receiver Informs sender ( telephone, FAX) if there is any discrepancy where the

contents are not in accordance with the accompanying documentation

Pathology Example

Diagnostic Pathological Specimen being sent by road in a container of formaldehyde solution

1. UN 2209 – Formaldehyde 2. PI 650 – Packing Instruction 3. UN 8 – Hazard Classification – Corrosive 4. Additional labelling common to all

EXEMPTIONS from Category B - UN 3373 (January 2007 edition of RID) page 23/24 Exemption applies to substances in a form that any present pathogens have been neutralised or inactivated (formaldehyde fixation, example above) such that they no longer pose a health risk. Such substances are not subject to RID. Diagnostic pathological specimens where there is a minimal likelihood that pathogens are present and provided that the specimen is carried in a packaging, which will prevent any leakage and which is also marked with the words “EXEMPT HUMAN SPECIMEN”, would fall into the exemption category.


In the case of the example above, the UN 2209 (formaldehyde) has been substituted for UN 3373 as the risk is not one of infection but that of formaldehyde i.e. UN 2209 and is transported under “Dangerous Goods” Where non-fixed pathological material is being transported, an element of professional judgement is required to determine if a substance is exempt. This judgement should be based on known medical history, symptoms and individual circumstances of the source and endemic local conditions.

Non Pathology Example

Category A

Diagnostic Specimen meeting the criteria for inclusion in Category A being sent by road

1. UN 2814 – Infectious Category A 2. PI 620 – Packing Instruction 3. UN 6 – Hazard Classification – Infectious 4. Additional labelling common to all

Non Pathology Example

Category B

Diagnostic Specimen not meeting the criteria of Category A

1. UN 3373 – Infectious Category B 2. PI 650 – Packing Instruction 3. UN 6 – Hazard Classification – Infectious 4. Additional labelling common to all



18.3 Appendix 2 Example of Tracker Form for Traceability (Internal) Clyde Pathology Services

Tracker Sheet

Complete all sections in Block Capitals

Dispatched From……………………………………….. Date Dispatched……………… Dispatched To…………….……..……………………… Time Dispatched….…….…..… Discrepancy Contact No……....…..….…….………….. Courier/NHS/Other……………. Extension……………………. Dispatched by…………………………………

Date Theatre Patient's Name D.O.B. No. of Pots Specimen Description

Spec taken Clinic

Date Received……………………. Received By………………………… Time Received……………………. Checked By…………………………

18.4 Appendix 3 Example of Tracker Form (External Transport)

Clyde Division Histopathology Service

Department of Laboratory Medicine LF-RPAT-SR002

V1.0

Issue Date: 1st February 2008 Royal Alexandra Hospital

Corsebar Road

Paisley PA2 9PN TEL: 0141 314 6647

Fax: 0141 314 6913

External Transport Delivery Tracker Form

In order to comply with CPA and the Royal College of Pathologists Guidelines, please acknowledge by

FAX receipt of the following material

Date

Patient Name + DOB Specimen Description Destination Department Destination Hospital Packaged By Courier / Taxi Firm Driver: Print Full Name Company Contact No.

I acknowledge receipt of the above material:

Please print your name in CAPITAL LETTERS:

……………………………………………………………………………………………..

Signed:

Date:

Please complete and fax this form to the number above as soon as possible to confirm receipt of requested material


appendix – policy template

Documents