Human Tissue Authority

The regulator for human tissue and organs

Part 2.1 - Inspection findings

The analysis of inspection findings under the revised standards is based on the 59 site visit inspections in the PM sector in the year to 31 March 2018. Each of these inspections were undertaken at different establishments. Of these 59 establishments, four were not licensed for PM examination, including one which was licensed for storage of relevant material only.

Inspection findings from the 99 routine site visit inspections undertaken in this sector from 1 April 2015 to 31 March 2017 were used as a reference dataset. Of those inspections, five establishments were not licensed for PM examination including three which were licensed for storage of relevant material only.

Shortfalls

In the 59 routine inspections in the year to 31 March 2018, a total of 510 shortfalls were identified.

In the 12 months to 31 March 2017 (the period immediately before the new standards came into force), shortfalls were identified at 75% of inspected establishments. The vast majority (90%) of these shortfalls were minor, with 10% of shortfalls being major. No critical shortfalls were identified during this period. 

The number and severity of shortfalls identified in the sector in the year to 31 March 2018 has increased compared to the previous 12-month period. 

The increase in the number of shortfalls identified since April 2017 may in part be due to how the standards are now structured, with a significant increase in the number of individual standards that have to be met, resulting in findings previously reported against one higher-level standard now being reported against several lower-level standards. 

Similarly, the higher number of standards may also account for some of the increase in the number of shortfalls. 

In the year to 31 March 2018, 69% of shortfalls were classified as minor, 29% were categorised as major and 2% being categorised as critical. Major shortfalls were identified in 66% of inspections in the PM sector (39 of 59 establishments). Critical shortfalls were identified at five establishments, representing 9% of establishments inspected in the sector. 

As noted above, a number of shortfalls against standards were identified repeatedly at establishments across the sector. These will be discussed, and advice given, later in this document.
 

Last updated on: 29 May 2019