Sangeerth Girirathan

From the Secretary of State 
The Rt Hon Grant Shapps 

Great Minster House 
33 Horseferry Road 
London 
SW1P 4DR 

Tel: 
E-Mail: 

Web site: www.gov.uk/dft 

14 July 2022 

Tom Osborne 
The Coroner’s Office 
Civic Offices 
1 Saxon Gate East 
Central Milton Keynes 
MK9 3EJ 

Dear Tom, 

Regulation 28 Report – Driver Hours’ for Goods Vehicles under 3.5 
tonnes. 

Thank you for providing a copy of your Regulation 28 report dated 19 May 
2022, following the Inquest into the death of Mr Sangeerth Girirathan.  

Firstly, I would like to place on record my sincere condolences for the death  
of Mr Girirathan. It is a tragedy when any person dies on our roads and 
despite Great Britain having some of the safest roads in the world I  
remain concerned about the 1460 who were killed on our roads in 20201. 

Drivers of commercial goods vehicles weighing 3.5 tonnes or less fall in-
scope of the GB domestic drivers’ hours rules (contained in the Transport Act 
1968). According to these domestic rules, in any 24-hour period the maximum 
driving time is 10 hours and the maximum duty time is 11 hours. Duty 
includes all periods of work and driving but does not include rest or breaks. If 
someone is self-employed, duty time is only time spent driving the vehicle or 
doing other work related to the vehicle or its load. There are no specific break 
or rest requirements for goods vehicles under these rules.  

However, four provisions of the Working Time Regulations 1998 (as 
amended) apply to drivers operating under these domestic rules. These are 
an entitlement to 5.6 weeks’ paid annual leave, a weekly working limit of 48 
hours (‘opt out’ available), health checks for night workers, and an 
entitlement to adequate rest. Adequate rest is defined as being long and 
continuous enough to ensure that a driver does not harm themselves, fellow 

1 https://www.gov.uk/government/statistics/reported-road-casualties-great-britain-annual-report-
2020/reported-road-casualties-great-britain-annual-report-2020 accessed 24 May 2022 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 workers or others and that they do not damage their health in the long or 
short term. 

The Health and Safety Act 1974 states that businesses are required to 
provide a safe working environment for drivers and all road users. 

The Driver and Vehicle Standards Agency (DVSA) is responsible for the 
enforcement of the GB Drivers’ Hours rules and last year made 15,464 traffic 
checks on light goods vehicles and 67 different people were fined for Drivers’ 
Hours related offences. 

With the information provided in the Regulation 28 report, it is not clear 
whether Mr Girirathan was working for a company or was self-employed and 
providing a delivery service.  

As I hope you will appreciate, I must point out that the Department is unable 
to give a definitive interpretation of the meaning and scope of any legislation 
as this is ultimately a matter for the courts to determine. We can, however, 
provide the Department's view.   

If Mr Girirathan did fall asleep whilst driving then it is the Department’s view 
that he may not have received the required adequate rest and therefore did 
not have a safe working environment. If you are able to provide us with the 
details of his employer, we will coordinate with the DVSA and ask them to 
investigate this case.  

Thank you for the Regulation 28 report. I hope I have assured you that there 
are relevant regulations for the driving of light goods vehicles. I hope you find 
this information helpful and are assured that the Department are taking 
appropriate action to respond to your concerns. 

Yours ever, 

Rt Hon Grant Shapps MP 

SECRETARY OF STATE FOR TRANSPORT

TheMK 

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MiIton Keynes 
University Hospital 
NHS  Foundation Trust 

Mr Tom Osborne 
HM Senior Coroner 
HM Coroner's Office 
Civic Offices 
1 Saxon Gate East 
Central Milton Keynes 
MK9 3EJ 

By email:

12 July 2022 

Dear Mr Osborne 

I am writing to formally respond to the Regulation 28 report to prevent future deaths you 
made following the conclusion of the inquest into the death of Sangeerth Girirathan on 6 
May 2022. 

You also wrote to me on 19 May 2022 on two matters raised during this inquest, but which 
did not form part of the Regulation 28 report; namely the disclosure of notes in a paginated 
and indexed format;  and the storage of data on monitoring units in the hospital, particularly 
the ICU. I will address these matters within this letter. 

Regulation 28 Report 
The Regulation 28 report reads as follows:  During the inquest it became apparent that in the 
ICU the alarms that are operating on the monitors had been disengaged. This resulted in the 
staff not being alerted when the patient's saturations fell below an acceptable level and he 
went into cardiac arrest.  My understanding is that if a patient is being monitored at all then it 
is essential that the alarms remain operational. I believe that all staff should be reminded of 
the need for the alarms to be active so that future deaths in similar circumstances do not 
arise 

Response 
There is no national guidance regarding frequency of observations on ICU and patients vary 
from those who are acutely unwell to those who are well and waiting for a ward bed and on 
occasions direct discharge home. Observations (frequency and type) are decided by 
ongoing dynamic risk assessments from the nurse looking after the patient with input from 
the medical team as required. 

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Milton Keynes
University Hospital 
NHS Foundation Trust 

Alarm fatigue is a recognised detrimental consequence of intensive,  continuous monitoring. 
As part of the wider learning from this incident, the importance of proportionate and 
appropriate use of alarms and alarm limits will be emphasised to all critical care staff. A 
reference is included at Appendix 1. 

All  registered nurses and consultant intensivists have been communicated to regarding the 
recommendations contained within the Regulation  28 report. The communication has 
reiterated that nursing staff must position themselves to have visibility of the monitor and 
when monitoring is deemed appropriate, the audible alarms set should reflect and augment 
the parameters monitored. If monitoring - intermittent or continuous but more important for 
the continuous - is deemed necessary then the alarms will not be disabled but parameters -
highs and lows - may be altered to alert us a different points for different patients to avoid 
'overuse' of the audible alarms. 

The senior nursing team and consultant intensivists are doing point prevalence surveys to 
support and education staff as to safe and effective monitoring. 

The ability to store data on  monitoring devices following an incident that may have 
caused harm 

Response 
The ICU has a monitoring system provided by Spacelabs. There are several options to 
retain information/data from this monitoring system. Some of these options are longer term 
and require input from IT and all methods have risks associated with them that might result 
in failure to capture the appropriate data. 

In the short term, all registered nurses, medical trainees, and consultant intensivists have 
been informed that in clinical situations where death may have been prevented or an 
incident may have resulted in serious harm, that the monitor should be quarantined and data 
preserved. As an interim solution, monitor data should be transferred into the monitor 
modules, uploaded into a Spacelabs transport monitor and preserved until the clinical 
engineering team has access to that monitor to download the data. The patient should not 
be unlinked from the monitor (i.e. 'discharged' or disassociated from the monitor) unless 
absolutely necessary (in the case of the monitor being required urgently for another patient). 
Registered nurses have received refresher training and have been competency assessed to 
ensure they can transfer data as above. 

In the medium term, with training there is also an opportunity to draw across additional 
observations that have not yet been saved to eCare.  In a situation where harm or death has 
occurred and the patient has not been discharged from the monitor, additional time points 

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NHS  Foundation Trust 

can be added to assessments that will pull through observations at that time point.  The 
downside to this will be that observations will not be corroborated in  real time and some 
readings may be artefactual if monitoring is not correctly attached at the time (dampened 
arterial line trace, sats probe that is incorrectly positioned etc) leading to inaccurate data. 

In the longer term, Spacelabs lntesys Clinical Suite held in the central station should be able 
to store 72 hours of data for a patient who has been on  a monitor in  ICU (or elsewhere in the 
hospital) and has since been discharged from that monitor.  72 hours of data can  be 
accessed from the moment a patient is discharged. However, the amount of data available 
reduces over that time frame as it's not designed as a data repository.  A business case is 
being produced to draw up a contract between Spacelabs and IT to further consider this 
option. 

An action plan detailing ongoing work is included at Appendix  2. 

Pagination and Indexing of Notes for Court Disclosure 

Response 
There is a meeting between your team and the MKUH Director of Corporate Affairs, 

 and Head of Clinical Governance and Risk, Tina Worth, on  19 July to discuss 

potential options and agree next steps to ensure disclosures to the Court are made 
appropriately, coherently and accessibly. 

I trust that this response is satisfactory and as always, please do contact me if you would 
like any further information or assurance on any of the areas above. 

Yours sincerely, 

Chief Executive Officer 

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 Appendix 1 Reference: Patient Monitoring Alarms in an Intensive Care Unit: Observational 
Study With Do-It-Yourself Instructions 

Monitoring Editor: 

Reviewed by

1 Department of Anesthesiology and Intensive Care Medicine, Charite - Universitatsmedizin Berlin, Corporate 
Member ofFreie Universitat Berlin, Humboldt-Universitat zu Berlin, and Berlin Institute of Health, Berlin, Germany 

2 Institute of Medical Informatics, Charite - Universitatsmedizin Berlin, Corporate Member ofFreie Universitat Berlin, 
Humboldt-Universitat zu Berlin,  and Berlin Institute of Health, Berlin, Germany 

3 Department of Psychology and Ergonomics (IPA),  Division of Ergonomics,  Technische Universitat Berlin, Berlin, 
Germany 

Felix Balzer, Institute of Medical Informatics, Charite - Universitatsmedizin Berlin, Corporate Member of Freie 
Universitat Berlin,  Humboldt-Universitat zu Berlin, and Berlin Institute of Health, Chariteplatz 1, Berlin, 10117, 
Germany, Phone: 49 30450 ext 651166, Email:

Abstract 

Background 

As one of the most essential technical components of the intensive care unit (ICU), continuous 
monitoring ofpatients' vital parameters has significantly improved patient safety by alerting staff 
through an alarm when a parameter deviates from the normal range.  However,  the vast number of 
alarms regularly overwhelms staff and may induce alarm fatigue,  a condition recently exacerbated 
by COVID-19 and potentially endangering patients. 

Objective 

This study focused on providing a complete and repeatable analysis of the alarm data of an ICU's 
patient monitoring system.  We  aimed to develop do-it-yourself (DIY) instructions for technically 
versed ICU staff to analyze their monitoring data themselves, which is an essential element for 
developing efficient and effective alarm optimization strategies. 

Methods 

This observational study was conducted using alarm log data extracted from the patient monitoring 
system of a 21-bed surgical ICU in 2019.  DIY instructions were iteratively developed in informal 
interdisciplinary team meetings. The data analysis was grounded in a framework consisting of 5 
dimensions, each with specific metrics: alarm load (eg, alarms per bed per day, alarm flood 
conditions, alarm per device and per criticality},  avoidable alarms,  (eg, the number of technical 
alarms),  responsiveness and alarm handling (eg alarm duration}, sensing (eg, usage of the alarm 
pause function), and exposure (eg, alarms per room type).  Results were visualized using the R 
package ggplot2 to provide detailed insights into the ICU's alarm situation. 

Results 

We developed 6 DIY instructions that should be followed iteratively step by step. Alarm load 
metrics should be (re)defined before alarm log data are collected and analyzed.  Intuitive 

 
 
 
 
 
 
 visualizations of the alarm metrics should be created next and presented to staff in order to help 
identify patterns in the alarm data for designing and implementing effective alarm management 
interventions.  We provide the script we  used for the data preparation and an R-Markdown file to 
create comprehensive alarm reports.  The alarm load in the respective ICU was quantified by 152. 5 
(SD 42.2) alarms per bed per day on average and alarm flood conditions with,  on average,  69.55 
(SD 31. 12) per day that both occurred mostly in the morning shifts.  Most alarms were issued by 
the ventilator,  invasive blood pressure device,  and electrocardiogram (ie,  high and low blood 
pressure, high respiratory rate,  low heart rate).  The  exposure to alarms per bed per day was 
higher in single rooms (26%,  mean  172. 9/137. 2 alarms per day per bed). 

Conclusions 

Analyzing ICU alarm log data provides valuable insights into the current alarm situation.  Our 
results call for alarm management interventions that effectively reduce the number of alarms in 
order to ensure patient safety and ICU staff's work satisfaction.  We hope our DIY instructions 
encourage others to follow suit in analyzing and publishing their ICU alarm data. 

 Appendix 2: Action Plan 

Improvement 
Objectives 

To communicate 
to all staff the 
need to store 
data on 
monitoring 
devices following 
any incident that 
might have 
caused harm 
All RNs to 
receive training 
and be assessed 
as competent on 
transferring data 
from  monitor to 
module 

Engage with 
Spacelabs to 
discuss effective 
data capture 
process 

Actions Taken 

Start date 

05/05/22 

Email all RNs 
Email all 
Consultant 
lntensivists 

Additional 
Support 
required 
Consultant 
lntensivists to 
communicate to 
medical trainees 

Review 
Schedule 

27/06/22 
To evaluate at 
Intensive Care 
senior nursing, 
medical and 
AHP group 

Outcome 

08/05/22 

Band 7s to 
facilitate 
process 

18/05/22 

27/06/22 
To evaluate at 
Intensive Care 
senior nursing, 
medical and 
AHP group 

25/05/22 
Communication 
received from 
Spacelabs 

Senior nursing 
team provided 
one to one 
training and 
competency 
assessment to 
all  staff 

Advanced Nurse 
Practitioner 
(ANP) Intensive 
care to 
communicate 
with Spacelabs 
representative 

Face to face 
meeting to 
review ICU 
Spacelabs 
central 
monitoring 
system 
capabilities 
Engage w ith 
Spacelabs, IT 
and Clinical 
Engineering to 
define and agree 
a process to 
effectively data 
caoture from 

08/06/22 

ANPto 
communicate 
with Spacelabs 
to arrange 
meeting 

ANP- Intensive 
Care emailed 
representatives 
from all 
specialist 
departments 
and company to 
oroceed to a 

25/05/22 

Add to medical 
equipment 
training for 
Space labs 
monitoring 
when 
confirmed. 

16/06/22 
Face to face 
meeting 
arranged 
between 
Spacelabs and 
ICU ANP 

21 /06/22 
Planned meeting 
with key 
representatives 
from identified 
departments 

All RNs to 
receive 
training and be 
assessed as 
competent on 
transferring 
data from 
monitor to 
module 
The data 
capture 
process is 
complex but 
potentially is 
not robust in 
present format 
for clinical staff 
to manage 
24/7. There is 
potential for 
alternative 
individual 
monitor 
solutions 
and/or central 
monitoring 
solutions 
which require 
further 
investiQation. 

Business case 
pre-approved 
and priority 
funding 
agreed to 
ensure IT & 
Spacelabs can 
update the 

 Improvement 
Objectives 

Spacelabs 
monitoring 24/7 
in the event of a 
clinical incident 

Actions Taken 

Start date  Additional 

Support 
reauired 

Review 
Schedule 

Outcome 

meeting for 
resolution 

Confirmation of 
contracts signed 
and work 
commenced will 
be provided 
ASAP. 

All RNs to 
receive training 
and be assessed 
as competent on 
transferring data 
from monitor to 
module 

Senior nursing 
team provided 
one to one, 
small group 
training ongoing 
training. 

21/06/22 

Ongoing 

Add to medical 
equipment 
training for 
Spacelabs 
monitoring 

Spacelabs 
lntesys 
Clinical Suite 
(ICS) held in 
the central 
station to store 
72hrs of any 
patient data 
who has been 
on a monitor in 
ICU or 
elsewhere in 
the trust and 
has since 
been 
discharged 
from that 
monitor. 72hrs 
of data can be 
accessed from 
the moment a 
pt is 
discharged. 
However, the 
amount of 
data available 
reduces over 
that time 
frame as it's 
not designed 
as a data 
repository. 
In a situation 
where harm or 
death has 
occurred and 
the patient has 
not been 
discharged 
from the 
monitor then 
additional time 
points can be 
added to 
assessments 
that will pull 
through 
obseNations 
at that time 
point. 
ObseNations 
will not be 
corroborated 
in real time 
and some 
readings may 
be artifactual if 

 Improvement 
Objectives 

Actions Taken 

Start date  Additional 

Support 
reauired 

Review 
Schedule 

Outcome 

monitoring is 
not correctly 
attached at the 
time 
(dampened 
arterial line 
trace, sats 
probe that is 
incorrectly 
positioned etc) 
leading to 
inaccurate 
data. 
Continue to 
reiterate the 
message to all 
staff, face to 
face, safety 
huddle, role 
modelling and 
direct support 
to ensure 
compliance. 

Ensure that 
nursing staff 
must position 
themselves to 
have visibility of 
the monitor and 
when monitoring 
is deemed 
appropriate, 
audible alarms 
set should reflect 
and augment the 
parameters 
monitored. 
Ensure that if 
monitoring is 
deemed 
appropriate, 
audible alarms 
set should reflect 
and augment the 
parameters 
monitored. 

Matron has 
communicated 
this to all  RNs 

26/04/22 

Band 7s have 
communicated 
this message 
via the 'safety 
huddle' which is 
communicated 
at every nursing 
hand over. 

09/06/22 
Evaluated, 
minuted and 
reiterated at 
senior nurses 
meeting 

27/06/22 
To evaluate at 
Intensive Care 
senior nursing, 
medical and 
AHP group 

16/05/22 

Band 7 has 
communicated 
to Consultant 
lntensivist 
Leads, Band 7 & 
8 RNs to 
support this 
process and 
ensure that this 
is being followed 
when attending 
patients and 
during ward 
rounds.