Compliance

HUMAN TISSUE DISPOSAL PROCESS
  1. Purpose
    1. This SOP ensures that disposal of Human Tissue samples within the Horizon laboratories are destroyed following authorization in a consistent and controlled manner in accordance with Human Tissue Act 2004.
    2. The procedure represents good practice for the handling of all tissue samples. It must be followed by all Horizon personnel working under the license.
  1. Scope
    1.     All Relevant Material as defined in Act 2004 which means material other than gametes, which consists of or includes human cells.
    2. This does not include embryos outside the human body, or hair and nail from the body of a living person.
  1. Responsibilities
    1. Only the Lead Scientist or BSO is authorized to dispose of human tissue.
    2. The Lead Scientist or BSO is responsible for making sure they have the correct samples to be destroyed.
    3. The Lead Scientist or BSO must ensure samples are approved for destruction by the appropriate manager.
    4. It is the responsibility of the lead scientist to ensure that corresponding paperwork, stock inventory and the database is accurately updated. Provided authorization has been received by BSO and the DI.
    5. Lab Staff handling/sending samples are responsible for wearing full PPE (lab coat, gloves, safety glasses). Full inspection of gloves must be carried out to ensure gloves are intact and safe at point of use. Double gloving is required at all times.
  1. Definitions
    1. N/A         Not Applicable
    2. SNB        Serial Number
    3. HD          Horizon Discovery
    4. FBS        Fisher BioServices
    5. PO          Postbank Analysis
    6. BSO       Biological Safety Officer
    7. PPE        Personal Protective Equipment
    8. DI           Designated Individual
    9. HTA        Human Tissue Act 2004
  1. Procedure
    1. Obtain approval to dispose of tissue
      1. Any human tissue samples that are not used in a product need to be disposed of accordingly and a record of the disposal needs to be maintained.
      2. Any unused sample must be returned to Cat II storage or disposed of in accordance with the HTA code of practice and letter of consent.
      3. Samples targeted for disposal will be checked against the consenting individual’s wishes.
      4. A notification of disposal must be in place prior to any disposal activity. This will capture the amount of material and the route of disposal (as defined in the letter of consent).
      5. The notification of disposal must be signed by a member of the Facilities team and a representative of the HTA Steering Committee.
      6. Complete form 6110 PTR-04 Human Tissue Disposal Record and obtain authorization to dispose of sample. All authorization signatures must be present before disposal of the tissue samples can occur.
      7. Save a copy in the production SNB folder and disposal folder located in the HTA folder. P:\1 - Common\H&S\HTA\Disposal Records
      8. The document should be named as follows: ‘SNB number, HTA, Disposal date yy-mm-dd’.
    1. Updates to Itemtracker with stock movement
      1. Login to ItemTracker using your username.
      2. Using either Map or Items, locate samples for disposal on item tracker, ensuring the correct vials are accounted for. Note the locations of the vials for disposal.
      3. Select items to be changed and click “Change” button
      4. Change sample status to “Destroyed” or an appropriate status as defined in the original consent.
      5. Insert a date in “Date removed from Stock”
      6. Insert an explanation in “Reason for Stock Adjustment” – include the disposal form reference in this field.
      7. Click okay.
      8. The samples should then be removed from stock/holding location and should be destroyed or handled as defined in the original consent form.
Note 1: Ensure a material transit agreement is in place for recipient of material (see Human Tissue transfer SOP)
Note 2: Autoclaves will be randomly checked that appropriate sterilization levels are at a level to inactivate biological contaminants
      1. Decontamination of consumables will mainly be conducted by autoclaving onsite followed by transportation to a local facility for incineration. The direct disposal of samples should be in accordance with the consenting individual.
      2. Decontamination of chemical waste needs to be by chemical means. Ensure contaminated surfaces are cleaned down with a bleach solution (minimum 1000ppm active chlorine).
    1. Publish disposal on the company website
      1. This disposal procedure  must be clearly published on the website
      2. Should there be any updates and re-issue of this procedure, QA should to notify and provide Central Marketing of the revised procedure and ensure the previous version is archived.
  1. Records
    1. 6110 PTR-04 Human Tissue Disposal Record
  1. Tools, Equipment & Information Systems
      1. Item Tracker
      2. Database
  1. Revision History
VersionIssue DateAuthorDescription of revision

V-01

19 Oct 2015

Sharmelee Thiahulan/Jade Kerri-Dibb

First formal issue of this procedure

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