Audit of Compliance with Human Tissue Act Legislation

For Post mortem Tissue Retention & Disposal

Dr S Venkatesan, Dr U Earl,

Mrs J Richards.

Cellular Pathology STHNHSFT

Human Tissue Act 2004• Human Tissue act deals with regulation of activities involving human tissue and is

responsible for maintaining legislations, policies and Codes of Practice.

Code 1: Consent

Code2: Donation of solid organs for transplantation

Code3,4: Post mortem and Anatomical examination

Code5: Disposal of human tissue

Code6: Donation of allogenic bone marrow and peripheral

blood stem cells for transplantation

Code 7: Public display

Code8: Import and export of human bodies, body parts and tissues

Code9: Research

Aim of the audit

• To measure the compliance of our lab with specific HTA codes of practice 1(Consent) and 5 (Disposal of tissues/organs)

• Time period: Post mortems performed at James Cook over three months (June, July and August of 2012)

Code 1- Consent72. Under the HT Act, consent is needed for the removal, storage and use of material from the deceased for all scheduled purposes as listed below

anatomical examination

determining the cause of death

establishing, after a person's death, the efficacy of any drug or other treatment administered to them

obtaining scientific or medical information, which may be relevant to any person including a future person

public display

research in connection with disorders, or the functioning, of the human body

transplantation

clinical audit

education or training relating to human health

performance assessment

public health monitoring and

quality assurance

Code of practice 1 (Consent)• 73. Although consent is not required for a coroner's post mortem, consent is required

under the HT Act for the continued storage or use of tissue, for scheduled purposes, once the coroner's purposes are complete

• 74-88: Who may give consent/Nominated representatives for PM dealing with adults

• 89-96: Consent issues dealing with PM of children

• 97-99; Providing information about the process

• 100: Disclosing information about the deceased

• 101-107: Written consent and consent for multiple activities

• 108-111: Exceptions for coroners

Code of practice 5

50. It is an offence under the HT Act to remove relevant material from a deceased person for any scheduled purpose without obtaining consent, unless it falls under the coroner’s authority.

51. Once the coroner’s authority has ended, it is not lawful to use or store tissue for a scheduled purpose without consent. Nor is it lawful to store tissue for a scheduled purpose without an HTA licence, subject to certain exemptions.

52. When the coroner has communicated the family’s decision to the pathologist or establishment holding the material, the pathologist should act on this information as soon as possible following the expiry of the coroner’s authority.

56. Material taken or retained under police authority is not subject to the provisions of the HT Act with regard to disposal.

Model consent form -AdultPart 1: Post-mortem examination

 

A post-mortem examination may be full or limited. The benefits and disadvantages of each will be explained to you. Please choose one of the following options.

 

Option 1: Consent to a full post-mortem examination

 

I consent to a full post-mortem examination of the body of the person named above. I am not aware that he / she objected to this. I understand that the reason for the examination is to further explain the cause of death and study the effects of disease and treatment.

 

Option 2: Consent to a limited post-mortem examination

 

I consent to a limited post-mortem examination of the body of the person named above. I am not aware that he / she objected to this. I understand that this may limit the information about the cause of death and effects of treatment.

 

I wish to limit the examination to (please specify) ……………..………………….

[See guidance note 1]

 

[See guidance note 2]

 

Signed by……………………………………..Name………………………………………………

 

Model consent form- AdultPart 2: Retention and future use of tissue samples

 

As part of a full or limited post-mortem examination tissue samples and small amounts of bodily fluids may be taken and used to determine the diagnosis and extent of the disease. Bodily fluids will usually be disposed of following a diagnosis. However, the tissue samples removed during a post-mortem examination can be stored for use in the future. The storage of the tissue samples and their later use require your consent. These samples can be valuable for the education and training of healthcare professionals, research and other purposes. Please indicate whether you consent to this:

 

I consent to the tissue samples being stored for future use, and

 

I consent to the tissue samples being used for the purpose of evaluating the efficacy of any drug or treatment administered to the deceased, or for review on behalf of the family if a need arises

 

I consent to tissue samples being used for education and training relating to human health, quality assurance, public health monitoring or clinical audit

 

I consent to the tissue samples being used for research that has been approved by an appropriate ethics committee

 

If you decide tissue samples should not be kept after the post-mortem examination, further diagnosis will not be possible and the tissue samples will be disposed of.

 

[See guidance note 3]

 

Signed by……………………………………..Name………………………………………………

 

Model consent form- AdultsPart 3: Retention of organs for more detailed examination

 

As part of a full or limited post-mortem examination, it may be necessary to retain some organs for more detailed examination. The person explaining about the post-mortem examination will tell you what may be required. The retention of organs for more detailed examination requires your consent. Please indicate whether you consent to this:

 

I consent to the retention, for more detailed examination, of the following organ(s):

 

……………………………………………………………………………………………………………………………………………………………………………………………………

Disposal of retained organs

 

After more detailed examination of organs removed during a post-mortem examination, they must be either stored for specified uses or disposed of in a lawful manner. You have the option of donating retained organs for research or medical education. Please indicate your wishes by choosing one of the following options:

 

I wish to donate retained organ(s) for research into related diseases, after which they will be disposed of lawfully

 

I wish to donate retained organ(s) for education, after which they will be disposed of lawfully

 

I wish the hospital to lawfully dispose of any retained organ(s), without them being used for research and/or education

 

I will make my own arrangements for lawful disposal of any retained organ(s) [See guidance note 4]

 

Signed by……………………………………..Name………………………………………………

Fetal & Perinatal Consent Form

2. Retention and future use of tissue samples Samples of your baby’s body fluids and tissues may be removed during the examination for laboratory examination. Some samples may be sent for tests such as microbiology and these will usually be disposed of following the examination. [Samples will only be sent for genetic tests if you have signed a separate Cytogenetics Consent Form]. Other tissue samples are made into blocks and slides for examination with a microscope. These blocks and slides may be kept as part of the medical record, so that in the future the diagnosis can be reviewed and further tests relating to your baby’s cause of death or illness carried out if necessary. They may also be used for medical education and audit. The storage of the tissue samples and their later use require your consent. Please indicate whether you consent to this: I consent to the tissue samples being stored to allow findings to be

reviewed in the future, or further investigations to be carried out on behalf of the family if a need arises

I consent to tissue samples being used for education and training relating

to human health, quality assurance, public health monitoring or clinical audit

I consent to the tissue samples being used for research that has been

approved by an appropriate ethics committee If you decide tissue samples should not be kept after the post-mortem examination, further diagnosis will not be possible. Please indicate one of the options below for the disposal of tissue samples: I wish the hospital to dispose of any retained tissue samples I will make my own arrangements for lawful disposal of any retained tissue samples Signed by…………………………………Name(s)………………………………

Local JCUH policy: SOP-0368

• Consented post mortems- Case must be authorised for a minimum of 35 days before tissue disposal.

• Coroners post mortems- A complete case has been defined as the Coroner’s authorisation (PM2) has been received.

• A spreadsheet is kept on the shared drive recording postmortem cases where tissue was retained Z:\Pathology\Cellular Pathology\MORTUARY\TISSUE RETAINED AT POST MORTEM.xls

• The spreadsheet is updated by mortuary staff following post mortem to record those post mortems where tissue was retained.

Local JCUH policy: SOP-0368

• The spreadsheet is updated by secretarial staff when the PM2 form is received and for coroner’s cases when the coroner’s release letter is received.

• and that the material has been released by the coroner for disposal or, for a consented post mortem, the case has been authorized for at least 35 days.

• APT/BMS/MLA staff may undertake the preparation of the material for disposal under the direction of a senior member of staff.

• On a quarterly basis (1st January, 1st April, 1st July and 1st October), the disposal is carried out and the excel spreadsheet updated accordingly.

StandardsStatement Target Exceptions

Next of kin wishes recorded as to tissue disposal

100% None

Next of kin wishes implemented 5 weeks after consented PM completed and report issued

100% Next of kin wishes not recorded

Next of kin wishes implemented following release of tissues by H.M. Coroner after coroner's investigations are complete

100% Next of kin wishes not recorded

Methods

• Original post mortem paper works

• Retrieval of data in APEX

Results

• Total number of cases over a three month period: 56 (All performed at James Cook University Hospital Mortuary).

• Consented post mortems-8, Coroners post mortem-48

Consented/Hospital post mortems

• Code of practice 1 (Consent): present in 100% of the cases.

• All cases- Slides/Blocks can be stored for research. Wet tissues(Placenta) disposed of in 100% of the cases after the case was authorised for 35 days.

Coronial post mortems

• Exempted: Forensic post mortems (4) and post mortems still at inquest (10). 48-14=34

• Types of disposal wishes seen in these cases: 11cases- Hospital disposal, 1case- Sent back to relatives for disposal, 22 cases- Tissue/slides can be retained for research.

11 cases needing hospital disposal• Protocol has been followed in 9/11 of the cases

• In the remaining 2/11 cases- tissues were disposed of after a very long time/stored more than the necessary period. Both the cases missed three cycles of disposal.

• They were not disposed when this audit was conducted in the last week of December 2013.

22 cases- Tissues/slides retained for research

• 7/22 did not have any wet tissue to be disposed- no action taken.

• Protocol was followed in 10/22 cases.

• In 5/22 case, the wet tissues were stored inappropriately and missed 3-6 cycles of disposal. 4 cases were still not disposed of when this audit has been carried out (Dec 2013).

Results

• Code 1 -100% compliance

• Code 5 (Disposal): 7/42 (17%) cases did not follow protocol out of which 6/7 cases were still present at the time of this audit when it should have been rightfully disposed off.

Standards

Statement Target Achieved

Next of kin wishes recorded as to tissue disposal

100% 100%

Next of kin wishes implemented 5 weeks after consented PM completed and report issued

100% 100%

Next of kin wishes implemented following release of tissues by H.M. Coroner after coroner's investigations are complete

100% 83%

Action plan

» Education of hospital staff taking consent for postmortem examination

» Education of Coroner’s Department about PM2 returns

» Education of cell path staff about following the SOP

» Discussion & clarification of roles & responsibilities of staff within cellular pathology

» Re-audit

HTA report from recent visit

• There is a clear and sensitive policy for disposing of human organs and tissue

• There are documented procedures for disposal of human tissue, which include methods of disposal for whole organs, wet tissue, wax blocks and microscope slides.

• Disposal details of organs and tissue blocks are recorded, including the date and method of disposal

• There is a rolling programme of tissue disposal that ensures that tissue, including microscope slides, is disposed of in a timely fashion when it is no longer needed for the purposes of the coroner to determine the cause of death

THANK YOU