Human Tissue Handling – Health and Safety

The Guy Hilton Research Laboratories

Keele University Medical School (Hartshill Campus)

Thornburrow Drive, Hartshill

Stoke on Trent ST4 7QB

The Huxley Building

Keele University

Keele

Newcastle-under-Lyme ST5 5BG

The Mackay Building

Keele University

Keele

Newcastle-under-Lyme ST5 5BG

Human Tissue Handling – Health and Safety 1

Human Tissues in the Laboratory 4

General guidelines 4

Risk assessments 5

Definitions 5

General 6

Performing a risk assessment 7

Training requirements for handling 8

Acquiring Human Samples 9

Human Tissue Samples 9

NRES Route 9

Consent Route 11

Human Stem/Primary Cell Samples 12

Other sources 13

Material Transfer Agreements 14

Other agreements 15

Record Keeping 16

Handling Human Tissue Samples 17

Designated laboratories 17

Techniques 18

Protective Equipment 19

Generic 19

Personal 20

Environmental contamination control 21

Safety cabinets 22

Leakages 24

Leaking Sample Recovery Protocol 25

Breakages 26

Major Spillages 27

Small Spillages 27

Record Keeping 28

Packaging and transporting Human Tissue Samples 29

Local laboratories 29

Courier 30

University Hospital of North Staffordshire 30

Third party 31

Import and export 32

Record keeping 33

Disposal of Human Tissue Samples and Associated Materials and Decontamination Procedures 34

Disposal/Decontamination routes 34

Disinfection Procedure 35

Human Tissue Sample Disposal 36

Disposal of Associated Materials 37

Equipment decontamination 39

Centrifuge Decontamination 39

Class I Protective Cabinet Decontamination 40

Class II Protective Cabinet Decontamination 41

Record keeping 42

Accident Reporting 43

Complaints Policy 44

Governance Policy 45

Staff responsible for implementing and updating procedures on Human Tissue Samples 46

Specific Training available in handling Human Tissue samples 47

The ISTM Human Tissue Committee reference and membership. 48

Associated Documents 50

Risk Assessment form for activities involving biological agents 51

COSHH assessment: Institute of Science & Technology in Medicine 64

Research Protocol Outline Form 66

Human Tissues in the Laboratory

General guidelines

1.  Person handling biohazardous material should be immunised against Hepatitis B and their response to the immunisation checked. The accuracy of this information must be updated at least annually by the group heads and recorded centrally (see Jeanette Forrester).

2.  No person who has not been trained by a senior staff member (supervisor or delegated deputy), and authorised to do so, is allowed to handle human specimens.

3.  All persons proposing to handle such specimens must first be thoroughly familiar with the contents of this protocol and other associated procedures referred to herein.

4.  Full risk assessment must be performed on all standard operating procedures using human material prior to use by any personnel (including senior staff). Subsequently, the relevant risk assessments must be read and understood (with signed confirmation that this has been done) by all staff prior to performing the procedure.

5.  All personnel handling human material must first have read and signed that they have understood the laboratory safety manual.

6.  Processing of samples must be performed in dedicated areas (see Page 17).

7.  Only designated area are to be used for the storage of samples of human material (see Page 17).

8.  CJD patient samples- contact head of dept, or Consultant Microbiologist (Dr Gray or Dr Orendi) immediately for advice before handling!

  1. Facilities for the handling of samples with a high probability of infection risk are not available within the Keele laboratories.

10.  For activities relating to materials covered under the Human Tissue Act a Biological Risk Assessment should be performed first followed by a detailed breakdown of the associated activities/process in the generic ISTM COSHH form. The biological risk assessment form and all associated Appendices are located on Page 51 –Page 63. The ISTM COSHH form is located on Page 64 – Page 65.

Definitions

‘Human material’, in the context of this document, includes blood samples, urine, tissue samples, and any other material of human origin (e.g. cerebrospinal and other fluids).

Risk assessments

Definitions

1)  A risk assessment (RA) describes the steps taken to identify a hazard and a measure of the probability of risk occurring due to that hazard.

2)  Risk is the chance of injury, damage or loss.

3)  A hazard is something that is, or has the potential to be, dangerous. These can be;

a)  Physical

b)  Chemical

c)  Biological

4)  Risk assessments should be suitable and sufficient such that appropriate levels of depth, control and monitoring are applied.

General

1)  A RA must be generated in advance for each new protocol implicated in the handling of human tissue.

2)  A RA should be undertaken for each staff member identifying specific risk areas which they are exposed to and what measures can be applied to minimize that risk.

3)  The individual RA should identify

a)  Work which cannot be undertaken without direct supervision by a person of responsibility

b)  Work which requires prior instruction on safe working by a person of responsibility before it can be started

c)  Work which presents little hazard and can be safely carried out without prior instruction.

4)  This should be performed;

a)  When that person starts work.

b)  Minimally on an annual basis.

5)  Included in the RA should be the relative dangers associated with handling;

a)  Biological specimens

b)  Infectious agents

c)  Chemicals and solvents

d)  Equipment

6)  Where the protocol involves handling human tissue has the risk of patient identification been eliminated?

7)  In all instances it is the responsibility of the human tissue handler or experimental practitioner to identify and minimize the risk exposure.

8)  An RA should only be performed by a practitioner who has sufficient knowledge of;

a)  Hazard Identity.

a.  Physical

b.  Chemical

c.  Biological

d.  Equipment

b)  Associated hazard safety procedures.

c)  Laboratory safety features.

d)  Knowledge of governing regulations

9)  The category into which each operation is placed will be made by the person of responsibility with due attention given to the likelihood that the operation can be carried out safely with the defined amount of supervision, not on whether time is available to give that supervision.

10) All active RAs should be reviewed , minimally, annually and/or whenever a modification occurs to the laboratory which may have an impact on the RA;

a)  New employee.

b)  New reagent.

c)  New equipment.

11) Where a hazard cannot be reasonably controlled, the risk must be transferred to those competent to deal with it e.g. a supervisor, responsible person, specialist contractor.

Performing a risk assessment

1)  Evaluate laboratory features

a)  Physical facility

i)  Air Flow

ii)  Access

iii)  Structural composition.

b)  Containment equipment

i)  Safety cabinets

ii)  Fume hoods

c)  Personnel

i)  Experience

ii)  Training

iii)  Immunization

iv)  Disability

2)  Evaluate procedural features.

a)  Biological/Chemical agent

i)  Pathogenicity

ii)  Mode of transmission

(1)  parenteral

(2)  blood

(3)  ingestion

iii)  Information available e.g MSDS

3)  Procedures performed

i)  Aerosol generating

ii)  Use of syringes and needles

iii)  Extreme temperatures

iv)  Sterile technique

4)  Assess features and categorize risk

a)  Do any features carry with them a risk of;

(1)  Death or cause permanent disability

(2)  Long-term illness or serious injury

(3)  Medical attention and several days off work

(4)  First aid needed

b)  Judge the likelihood of it happening

i)  High

ii)  Medium

iii)  Low

iv)  Very low

5)  Maximize efforts to minimize risk to Low/Very Low likelihoods in all instances.

Training requirements for handling

1.  Only staff that has completed training by a senior staff member are permitted to handle human material. This must include practical assessment of the contents of this document, associated general standard operating procedures (e.g. use of centrifuges, safety cabinets, etc) as well as specific SOPs. In addition, formal training sessions in handling such materials will be given. Those performing procedures involving human material must either have attended, or registered to attend one of these sessions.

2.  Formal training will consist of a 1 hour session on the principles of handling materials. Practical training by senior staff must consist of observation followed by supervised performance of the procedure. Once training is at a satisfactory level as assessed by a senior staff member, this must be recorded as a signed document of assessment.

3.  Senior staff must ensure that standards are maintained by performing annual spot checks to ensure compliance with written protocols.

4.  Designated safety personnel will perform annual random independent spot checks to assess compliance.

Acquiring Human Samples

Human Tissue Samples

NRES Route

1) Before undertaking any study which involves an application for NRES-approval the use of human tissue samples local rules require that Independent Peer Review (IPR) is first obtained

Keele University contact: Nicola Leighton, Research Governance Officer, Office of research and Enterprise, Dorothy Hodgkin Building, Room DH1:13, Keele university, staffs, ST5 5BG. Tel 01782 583306, e-mail

University Hospital North Staffordshire contact: Dr Darren Clements, R&D manager (UHNS), North Staffordshire Medical institute, Hartshill Road, Stoke-on-Trent, Staffs, ST4 7NY. Tel 01782 554 839, e-mail

The IPR form is located from Page 66-73 Page of this document. Advice on completion of this form should be sought from the individuals named above.

2) Following on from successful IPR approval must then be sought for any study from the NHS Research Ethics Committee (https://www.nresform.org.uk). This procedure will be performed in close collaboration with the participating clinician and the UHNS R&D (see Dr Darren Clement, detailed above). Application will be made to the relevant Local Research Ethics Committee (LREC) through this portal.

N.B. Where a research project has LREC approval it is not within the remit of the Human Tissue Act. Furthermore where any study has started within 2 years of its approval date it is not a requirement to apply for an extension of the approval period. The approving LREC should be receiving annual progress reports including an explanation of why the study is going to take longer to complete than was originally estimated.

3) The Chief Investigator of any study which has successfully obtained LPR and LREC approval is responsible for the secure storage of signed participant Consent Forms and of all approval documentation. This documentation must be made available for inspection upon request by any Secretariat-approved internal or external auditing body.

4) Where tissue samples are obtained from hospital sources other than University Hospital of North Staffordshire it is envisaged that Chief Investigators will act in close collaboration with the pertinent R&D departments.

5) Where tissue samples are obtained from non-hospital sources such as Tissue Banks (e.g. NBTS, Parkinson’s Disease Brain Bank) the Bank will have established Consent procedures. While research using Bank materials will still require LREC approval the Chief Investigator will not have accompanying Consent documentation and covering material from the Bank will suffice in this instance.

Consent Route

1) Human tissues obtained under Consent but without NRES approval must be logged upon entry and Nick Forsyth or Paul Eggleston immediately notified and shown the signed consent form.

2) Human Tissues obtained under consent but not for a NRES-approved project must be obtained whilst following the guidelines outlined in the University Hospital of North Staffordshire document Policy No. (C43) Policy and Procedures for Obtaining Consent (including the application of the Mental Capacity Act 2005).

Human Stem/Primary Cell Samples

Human Embryonic Stem Cells

All work carried out using Human Embryonic Stem Cells (hESC) must have received prior approval from the UK Stem Cell Bank.

All hESC should be sourced from either the UKSCB or where an alternate source is required it should be done only once a UKSCB ‘Approval to Import’ has been granted.

All hESC lines must be logged into the Stem/Primary Cell Logbook located at the reception of the Guy Hilton Research Centre.

Mesenchymal Stem Cells

All human mesenchymal stem cells (hMSC) lines must be logged into the Stem/Primary Cell Logbook located at the reception of the Guy Hilton Research Centre.

N.B. If bone marrow aspirate is used this must first be logged in the Tissue Book. Once removed from the recovery vessel and inactivated the aspirate must be marked as disposed of in the Tissue Logbook. Following disposal of aspirate a new entry must be entered in to the Stem/Primary Cell Logbook located at the reception of the Guy Hilton Research Centre.

Primary Cells

All human primary cells must be logged into the Stem/Primary Cell Logbook located at the reception of the Guy Hilton Research Centre. Where these are recovered from Human Tissue samples the procedures outlined previously for obtaining the Human Tissue must first be followed. In addition when the Human Tissue enters the building it must first be logged in the Human Tissue Log and once disposed of it must be marked accordingly.

Other sources

When obtaining cells from other sources i.e. commercially, researchers must first obtain a clear ethical statement from the commercial supplier that the materials have been obtained under practices which are deemed appropriate to those laid down by the Human Tissue Authority and the EUCTD.

Material Transfer Agreements

All Material Transfer Agreements (MTA), Materials Use Licenses (MUL) or Memorandum of Understanding (MOU) must be undertaken through and with the guidance of the Office of Research and Enterprise (http://www.keele.ac.uk/research/) at Keele University. Full Contact details are below;

Research and Enterprise Services

Dorothy Hodgkin Building

Keele University

Staffordshire

ST5 5BG

Tel +44 (0)1782 583371

Fax +44 (0)1782 583740

Other agreements

All other agreements must be undertaken through and with the guidance of the Office of Research and Enterprise (http://www.keele.ac.uk/research/) at Keele University. Full Contact details are below;

Research and Enterprise Services

Dorothy Hodgkin Building

Keele University

Staffordshire

ST5 5BG

Tel +44 (0)1782 583371

Fax +44 (0)1782 583740

Record Keeping

1) All records must be maintained in a secure environment. This can be in either a secure, locked, metal filing cabinet or alternatively, in a password protected device. The responsibility for the maintenance of all records concerned with the acquisition of Human Samples (Tissue or Stem Cells or other relevant material as defined by the Human Tissue Act (2004)) lies with the principal investigator or chief investigator overseeing the research.