FOI release

Freedom of Information request on any/ near safety breaches at the National Institute for Biological Standards and Control in the past 8 years (FOI 21/1071)

Published 27 April 2022

19th October 2021

FOI 21/1071

Dear

Thank you for your email of 21st September 2021 requesting information under the Freedom of Information Act 2000 relating to all safety breaches or near misses, including all incidents that were notified to the Health and Safety Executive, during the past 8 years at the National Institute for Biological Standards and Control, specifically for the period 01 January 2014 to the date of your request.

You have requested details as follows:

— All details included in RIDDOR reports to the HSE — The date of the incident — The matter that was investigated — Name of duty holder — A detailed summary of the incident including any executive summary that was prepared — The biological agents or substances that were involved — The outcome, including any enforcement action

I can confirm under Section 1(1)(a) of the FOI Act, that the Medicines and Healthcare Products Regulatory Agency (the Agency) does hold the information requested.

You have asked that if this information is held in a structured database format, please provide a copy of the structured data that covers these cases. If also held in paper or PDF form, please also provide a copy of these forms, preferably in searchable PDF form if possible.

We hold the data in a safety management system, and the details requested are listed in the appendix attached.

The Freedom of Information Act only entitles you access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit Page 2 of 5

https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

If you have a query about the information provided, please reply to this email.

Yours sincerely,

Freedom of Information Officer

Appendix

Summary of all safety breaches or near misses, including all incidents that were notified to the Health and Safety Executive, at the National Institute for Biological Standards and Control, between 01 January 2014 and 21st September 2021.

The Duty Holder in all cases was the Medicines and Healthcare products Regulatory Agency

RIDDORS and SAPO Dangerous Occurrences

Date	Description	Pathogen/agent/chemical	Outcome (including any enforcement action)
04/07/2014	RIDDOR: Over 7-day injury A member of staff tripped up the stairs caused by a sprained ankle. There were no hazards identified, and the stairs were in good condition with handrail in place. Lighting in the area was adequate. The staff member reported that they were rushing and not holding onto the hand rail when they tripped up the stairs.	N/A	No further action by the HSE
09/09/2014	RIDDOR: Over 7-day injury Working on a ladder and undoing some pipework resulted in back strain	N/A	No further action by the HSE
02/09/2015	Dangerous Occurrence under SAPO; Smoke test of Effluent Treatment Plant (EPT); laboratory live no staff in the area, laboratory not accessed; extract and inlet vents had to be covered for the test and caused pressure to fluctuate; risk of loss of containment was NIL; HSE investigated	N/A. No loss of containment	No further action by the HSE
18/10/2015	Dangerous Occurrence under SAPO; site wide power failure; live lab with no lab work at the time, 2 staff in lobby; power outage not specific to site; pressure anomalies between rooms were minor and risk of loss of containment was NIL; HSE investigated	N/A. No loss of containment	Enforcement letter sent by HSE to address issues regarding current arrangements for safety critical equipment.
04/11/2016	RIDDOR Dangerous Occurrence: TB culture plate dropped outside of MSC (agar gel intact but lid off). Emergency procedure was followed. Reported to HSE, local investigation findings shared with HSE.	TB	No further action by the HSE.
29/11/2016	RIDDOR Dangerous Occurrence: Work being conducted in a Containment Level 3 laboratory. The procedure involved the transfer of eggs from an incubator to microbiological safety cabinet. The eggs had just been inoculated with influenza virus, thus low amounts of virus growth. The operator removed two trays of eggs from the incubator: one egg fell from the tray and broke. The operator immediately returned the eggs to the incubator and evacuated the laboratory. Due to other control measures being in place no harm arose out of the incident.	Influenza	Enforcement letter sent by HSE to address effective selection of control measures and to revise risk assessments that underpin selection criteria. All actions addressed and closed by HSE.
10/10/2017	RIDDOR Dangerous Occurrence: Potential occupational exposure to influenza during sample checking (low risk but the affected person administered Tamiflu). Reported to the HSE. Investigated by HSE.	Influenza	No further action by the HSE.
27/09/2018	RIDDOR Occupational Disease: During vibration for powered gardening equipment, the gardener complained of discomfort in his hands, the survey was halted at this point. Following a medical diagnosis of HAVS, a RIDDOR report was made.	N/A	Crown Improvement notice served to address effective assessment of risk. Notice complied with and closed out by HSE.
09/10/2020	RIDDOR Over 7-day injury: The injured person hurt his back when moving an obsolete coffee machine from a trolley to the waste compound.	N/A	No further action by the HSE. Local investigation completed.
26/11/2020	RIDDOR Dangerous Occurrence: Spillage outside Class I MSC of liquid potentially contaminated with SARS-CoV2 due to a leak of the outer container. The primary container remained intact.	SARS-CoV. Assessment confirmed no leakage therefore no loss of containment.	Enforcement letter sent by HSE to review assignment of work activities, development of procedures and monitoring effectiveness of controls.

HSE notified of incidents (non-reportable under RIDDOR or SAPO)

Date	Description (incl. executive summary)	Biological agent or substance involved	Outcome (including any enforcement action)
24/02/2017	Ceiling in CL3 Laboratory has been damaged due to hyper negative pressure whilst attempting to reset the Air Handling system, following a frost protection lock out.	HIV. No loss of containment	HSE notified, no further action taken.
06/12/2017	Maintenance engineers were working on the Air Handling Unit (AHU) above the a CL3 laboratory when they realised it was in fumigation mode.	Formaldehyde	HSE notified, no further action taken.
23/04/2018	AHU switches were being changed to key switches by Maintenance, this caused an issue with the control system, resulting in positive pressures.	No loss of containment, laboratory was live; no infectious work has commenced following recent routine maintenance shutdown.	HSE notified, no further action taken
07/01/2019	AHU turned off to CL3 suite whilst staff working at an MSC.	No loss of containment; MSC was running; no infectious materials were open or being manipulated. Realisation in early stages and work stopped.	HSE notified, no further action taken.
02/0/2019	Contractor - unauthorised access to restricted area - near miss - could have been exposed to fumigant since facility was being fumigated (not live). Immediate action taken to remove contractor from site. New procedure for Access Authorisation introduced.	Formaldehyde	HSE notified, no further action taken.
09/07/2019	Staff member concerned that they have felt a splash to eye with HCV-containing plasma. Very low risk. Work conducted correctly in functioning MSC and with dilute sample. No ill health occurred.	Hepatitis C Virus	HSE notified, no further action taken.
12/07/2019	Planned power outage to CL3 lab. Unauthorised access to CL3 suite during planned remedial works.	No loss of containment.	HSE notified, no further action taken.
09/2019	HG3 sample found in CL2 freezer (Classification of flu strain had changed) - dynamic risk assessment used to move freezer contents to CL3 lab for further investigation.	No loss of containment, vials intact	HSE notified, no further action taken.
04/08/2020	Removed sample tubes from sonicator in CL3 and noted volume decreased in 3 of the tubes. Possible loss of sample into sonicating water bath. Liquid decontaminated (2N NaOH) and placed into MSC.	vCJD	HSE notified, no further action taken.
22/11/2020	A tap was left on during the CL3 lab check on Saturday morning resulting in a flood.	No loss of containment, clean water	Investigated by HSE, no further action

Crown Prohibition Notice

Date	Description (incl. executive summary)	Biological agent or substance involved	Outcome (including any enforcement action)
05/2018	PSSR serious defect report - Autoclave taken out of immediate service - Issue related to pipework removed as part of testing which was not re-installed correctly before final pressure testing	Pressure	NIBSC reviewed associated documentation (SOPs etc) and amended test specification to ensure all steps were covered accurately. Written schemes of work updated.