Human Tissue Authority

The regulator for human tissue and organs

Feedback from the HTA Human Application (HA) sector COVID-19 questionnaire

The HTA would like to thank establishments in the HA sector for the prompt completion and return of the HA sector COVID-19 questionnaire at such a challenging time.

The exercise has been valuable in helping maintain our oversight of the sector during a period when site visit inspections have not been possible. The information we have received shows that most HA establishments have identified and implemented various control measures to mitigate the risks posed by the pandemic. This guidance sets out further considerations for HA establishments following the information we received from you.


Levels of activity in the sector and risk assessments

Many establishments reported that the level of activity in some or all areas reduced or ceased during the early stages of the outbreak. Many also stated that their intention was to resume activities in the near future. Establishments in this position should make sure that appropriate risk assessments are carried out before activities resume. The scope of risk assessments should be informed by how services have been affected over recent months.

For example, you should consider the risks associated with any, or all, of the following factors:

  • staff training and competency (for example, are new staff now involved in the carrying out of licensable activities, or are routine competency assessments needed before a resumption of work?);
  • equipment maintenance and calibration; and
  • changes in operational capacity (for example, due to staffing or associated with support functions such as testing or sample transportation).

Where additional staff have been recruited or redeployed to undertake licensable activity, establishments should remember to undertake full staff training and to make sure the training is documented.

Contingency plans

Contingency plans should be reviewed and where appropriate, updated. The plans should reflect any lessons learned from the early stages of the pandemic. Establishments should consider whether adequate contingency arrangements are in place to maintain critical equipment and to respond to temperature monitoring systems. You should also take into account:

  • possible disruption caused by changes to staff or contractor availability;
  • potential difficulties associated with travel; and
  • restrictions to facility access.

Release of tissues and cells

Establishments that release tissues or cells that require the donor to be retested 180 days post-donation, should consider how the retesting will be managed and undertaken. Even where stocks are low, tissues and cells must not be released without the 180-day donor retesting, except in exceptional circumstances.

If there is a need to release tissues or cells without 180-day donor retesting - for example, in cases of urgent medical need and where no other suitable source of tissues or cells is available - then release must only take place under concession. Each concessional release must be risk assessed and the treating clinician and recipient made aware of the risks before end-use. Establishments may wish to consider additional testing methods so that the 180-day testing is not required. You can find more information on mandatory testing requirements on our HTLV-1 policy page. Alternatively, you can contact us directly for further advice.

Internal and independent audits

We expect that internal and independent audits continue in line with existing schedules, where possible. If staffing is an issue, alternative arrangements can be made to carry these out. However, whoever conducts the audit should be appropriately trained and should follow agreed procedures. Audits should still be documented as normal.

Audits that cannot be carried out due to the pandemic should be rescheduled at the earliest opportunity. If independent audits cannot be performed, establishments should consider increasing the scope and frequency of internal audits to help provide the necessary assurance that systems and practices continue to operate as expected. An enhanced programme of audit may also be beneficial in assessing the suitability and effectiveness of any new measures put in place in response to the pandemic. You can find more advice on our Independent Audits webpage.

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Last updated on: 30 Sep 2020