Human Tissue Authority

The regulator for human tissue and organs

Premises facilities and Equipment (PFE)

The Premises, Facilities and Equipment standards include storage arrangements for bodies and maintenance of the premises and equipment to ensure dignity of the deceased is maintained. 164 shortfalls out of 59 inspections were identified.

Key findings:

  • fridge and freezer alarms not being tested, or if they were tested, this was not recorded;
  • testing only challenged the alarm itself with the follow-up call-out procedure not being tested to ensure that it also worked correctly;
  • fridges and freezers did not have a lower alarm trigger point;
  • alarms were routed to areas that were not staffed out-of-hours; and,
  • fridge and freezer temperature records were not reviewed to identify trends.

The HTA’s good practice advice based on these observations are given below:

  1. Alarms should be regularly tested, including any follow-up procedure, and the outcome of these tests should be recorded.
  2. Fridge and freezer temperatures should be regularly recorded and reviewed in order to capture any anomalies, such as an increase in the average temperature. This could help identify any problems early and potentially avoid the risk of more significant problems, such as complete breakdowns.

 

Another repeat finding under premises was deterioration due to age and wear-and-tear leading to the exposure of porous surfaces within the mortuary. Some of the main causes identified were:

  • rusting of equipment and inside fridges;
  • concrete or wood becoming exposed after being damaged by trolleys repeatedly knocking against them;
  • older fridges being constructed in such a way that porous material was incorporated into the framework, for example wood in the doors;
  • gaps where different surfaces meet, such as the PM suite flooring and an adjoining wall, in which fluids could become trapped; and,
  • lack of cleaning schedules and inadequate cleaning, particularly of the drains in the PM suite and the insides of fridges.

The HTA’s good practice advice based on these observations are given below:

  1. Establishments should pay particular attention to any porous areas when completing health and safety risk assessments. Porous surfaces cannot be properly cleaned and decontaminated presenting a potential health and safety risk to staff.
  2. Forward planning of preventative maintenance and taking action to deal with areas that require attention as soon as possible will help prevent larger scale issues.

 

Issues identified in the compliance assessments in relation to storage were also reflected in inspection findings:

  • establishments not transferring bodies to frozen storage in line with HTA guidance due to a lack of freezer space, particularly for bariatric cases;
  • insufficient refrigerated storage capacity, for normal and bariatric bodies;
  • refrigerated temporary storage units becoming part of regular storage, leaving little contingency storage; and,
  • erection of temporary units in less than ideal places, such as the PM suite.

The HTA’s good practice advice based on these observations are given below:

  1. Establishments are reminded about the HTA’s sector guidance advising that in order to maintain the integrity and dignity of bodies, they should be transferred to freezer storage within 30 days, unless further examination or release of the body is imminent.
  2. Establishments with insufficient storage space, especially bariatric or freezer space, should endeavour to have written agreements with other establishments to supplement capacity when needed.
  3. If there is no bariatric storage available for bariatric bodies, chiller blankets should be available for immediate management prior to transfer of the body to appropriate storage.
  4. Storage issues, in particular concerning freezer and bariatric storage capacity, should be escalated as appropriate to the relevant Trust, Health Board or Local Authority risk register.

 

Another issue frequently identified in this category concerned regular maintenance of equipment and records of testing for ventilation systems. Generally, the issue was not that this was not happening but rather that the work was managed by the Estates Department, with the DI or Mortuary Manager not having access to the reports and so not being able to confirm whether maintenance was up-to-date.

The HTA’s good practice advice based on these observations are given below:

  1. The DI and staff working in the mortuary should have a schedule of when any maintenance and/or testing is due for equipment and receive copies of the reports. This will provide assurance that maintenance happens in a timely manner, issues identified are rectified swiftly and that the ventilation system is working to the required standard (10 air changes an hour).
  2. In relation to personal protective equipment (PPE), facemasks should be a filtering face piece, level 3 (FFP3) and face-fitted. If an individual has facial hair or is unable to work with this equipment, a fully ventilated hood alternative should be used.
  3. Establishments should follow the HSE guidance ‘Managing Infection Risk When Handling the Deceased’ issued in July 2018
Last updated on: 29 May 2019