1. How many serious incidents occurred during surgery in the years 2018, 2019, 2020, and 2021 up to the date received (07/05/2021)? Please provide a breakdown by year. a. For each serious incident, please provide as much detail as possible within the time/cost framework, and without any identifying information that could incur a personal data exemption.

a. Please provide a breakdown by i) never events ii) all other serious incidents Please include locum or agency staff if you hold information on them. – Serious Incident Investigation are systems based focus and so personal staff details are not included.

Question 1:

Serious Incidents that have occurred during surgery for the years 2018-2021 are as follows:

STEIS no./Case no. NEVER EVENT Y/N

Description

YEAR: 2018

2018/1063 SII 255 N Unexpected surgical outcome

2018/2359 SII 257 N Failure to meet core standards within DSU – flexicystoscopy list

2018/4449 SII 259 Y Tooth extraction please note wrong tooth extraction has since been excluded from the Never Events list

2018/4860 SII 261 Y Retained foreign object

2018/23675 SII 285 Y Wrong site injection - ophthalmology

YEAR: 2019

2019/6378 SII 306 N Intra-ocular lens implant outcome

2019/6543 SII 307 Y Wrong site injection – ophthalmology

2019/10465 SII 316 Y Retained foreign object

2019/14419 SII 325 N Misplaced swab –

YEAR: 2020

2020/3761 SII 357 Y Retained vaginal swab

2020/16491 SII 374 N Breast Implant – unlicensed product

YEAR: 2021

2021/11130 SII 408 N Unintended outcome of knee surgery

2018/1063 SII 255

Unexpected surgical complication leading to patient harm

Root cause – The Surgery caused the vascular injury and though it is not clear at which point, this is most likely to be at insertion

of the visiport. All processes were appropriately followed to minimise the injury but we accept that the surgery caused the injury.

Recommendations –

A theatre alert bell for DSU.

A theatre bleep, equivalent to the ‘Crash’ team, to include surgeon. Pagers carried by key members for group are fast bleeped via 2222.Switchboard to contact appropriate surgeon on call directly.

Regular SIM training in such emergency situations, based in DSU theatre environment.

2018/2359 SII 257

Failures of decontamination processes during high volume day surgery list.

Root cause- The process for tracking scopes to patients was not robust; poor separation of dirty and clean equipment work flow

enabled a used scope, not bagged in the sluice to be taken back into the sterile clinical area, where this could be picked up as

clean.

Recommendations –

Used scopes once decontaminated within the sluice must be placed in a red bag prior to being returned to the storage cabinet for

used scopes.

The SOP for Decontamination to be completed and disseminated to staff.

The only notes in the theatre should be those of the individual patient undergoing the procedure. 4 The printed label identifying the

scope must be fixed in the notes so that it can be viewed

without risk of damage to the label.

The Haematuria Clinic list should be reduced by 1 patient from 13 to 12. Build a ‘fire-break’ into the list allowing staff to review any

issues or concerns

There must be an agreed local induction for temporary staff who assist in the theatre to ensure they are competent to undertake the

tasks/roles required

All clinicians must lead a safety briefing/stop moment at the beginning of the list

2018/4449 SII 259

Never Event – Wrong tooth extraction

Root cause- Human error in distinguishing between a deciduous and adult tooth due to the factors described above which misled

the operator. In this case it may have been more difficult to distinguish between the crown of the baby tooth and its adult successor

on the contra lateral side, due to its flattened appearance of the anatomy of the cusps of the LL5 (lower left adult) which would

usually be symmetrical.

Recommendations-

Case to be discussed as part of clinical governance sessions to raise awareness and reiterate the importance of preoperative

assessment , clinically and radiographically prior to tooth extraction

2018/4860 SII 261

Never Event - Retained tip of forceps post laproscopic removal of kidney. Patient returned to theatre for removal of foreign object.

Root cause- Poor integrity of forceps which fractured and retained a tip intraoperatively. Due to a lack of a robust system at both

local and National level that ensures instruments are checked for completeness and integrity post procedure this was not identified

at the time.

Recommendations –

Standard operating policy and the WHO surgical checklist to be revised. This should include the checking for completeness and integrity of instruments as a standard check for every procedure. Control sheet for every operating tray of instruments for laparoscopic procedures to include the check that tips of laparoscopic forceps are present

All staff to be reminded of the AFPP standard which does not recommend Scrub practitioners to dual role

To be taken to the instrumentation group to feed into the Trusts management of limited use surgical instrumentation

2018/23675 SII 285

Never Event-Wrong site injection

Root cause - A failure in the Intravitreal checking protocol, which requires all members of the theatre team including the doctor

performing the injection to complete verification of correct patient, correct eye and correct drug, resulted in human error occurring

when a review of Medisoft EPR software took place.

Missed opportunity to perform a stop moment and re-check thoroughly in accordance to the (IVT protocol) when a discrepancy was

highlighted by the patient.

Recommendations –

Protocol review and LocSSIPs development, including a surgical checklist with Medisoft documentation of completion, for

intravitreal injection

Develop an appendix to the Trusts surgical site marking policy relevant to intravitreal injection

DMT to support the Ophthalmology OPD Workforce review to ensure activity is supported safely

Case to be brought to the Retinal Clinical Governance session for discussion, information sharing and development and

implementation of actions above and disseminated to the rest of the department

Cascade report to all departments in the Trust

2019/6378 SII 306

Intra-ocular lens implant –complication of device/product.

Root cause - Complication of cataract surgery due to patient factors and the physical properties of the lens used.

Recommendations – Report to be taken to Ophthalmology departmental clinical governance session for discussion and learning

Look back exercise to identify any further similar cases and any lessons to be learned from the introduction of the Zeiss lens

system

2019/6543 SII 307

Ophthalmology Botox - Never Event- wrong site injection. Root cause - Human error due to lack of a LocSSip within outpatients departments regarding the process for checking and site marking prior to injections lead to a patient having injections not in line with the planned procedure.

Recommendations –

Formulate LocSSIP for Botox injections in outpatients. This must include the patients pre planned procure and dosage of Botox to

be used and this must be confirmed by both staff, along with the patient. This must also include site marking if required and a

stop moment prior to proceeding

Appropriate nursing staffing levels in clinics including trained staff. DMT to support the Ophthalmology OPD Workforce review to

ensure activity is supported safely

All Ophthalmology outpatients departments to have SOP’s for members of staff in order to orientate themselves to clinics they may

not have worked in before.

Cascade to all departments in the Trust

2019/10465 SII 316

Retained Foreign object

Root cause - No root cause for this incident was identified.

Whilst it is acknowledged that the parts of drain that were retrieved from the patient’s healed wound on 8th May 2019 are the same

size and make as the drain that was inserted during the first procedure (15Fr Blake), there is no evidence that any drain parts were

left in situ when the drain was removed at SDH on 25th July 2018. The medical records show that all the correct procedures were

conscientiously followed throughout the management and removal of the drain. It is concluded that it is unlikely that the retained

drain pieces were left inside the patient at SDH during either of the two surgical procedures the patient underwent.

Recommendations –

None

2019/14419 SII 325

Missing swab -It was identified at the first count during the LSCS (following a failed trial of instrumental delivery), that there was a

30X30 swab missing. This was flagged to the theatre team and the surgeon. The surgeon was sure that the swab was not in the

abdominal or uterine cavity so continued with surgery. A search of the bins and the previously counted swabs proved unsuccessful

in locating the missing swab and in view of the patient becoming uncomfortable and distressed it was decided that the surgery

should be completed and the patient moved to the anaesthetic room.

Root cause - The failure to follow hospital policy in relation to Instrumental needle and swab counting and sign out procedure. The

Trust’s Policy is not specific about how to conduct counts when a second procedure takes place.

Recommendations –

A change in practice is required hence The “Accountable Items, Swab, Instrument and Sharp Counts Policy” needs amendments to

include:

If multiple instrument trays are used, a full swab count must take place for each tray at the time of completion of each procedure

and the WHO surgical safety checklist should be completed for each procedure.

The Swabs should not be migrated from one procedure to another.

There should be clarity around who is conducting the count with the scrub practitioner. The huddle at the start of the procedure

should be used to identify an individual, normally the circulating nurse.

A change in practice to make it routine that when a second procedure is undertaken the swab board is divided so that separate

counts can be recorded.

Appropriate discussion and reflection from scrub nurses involved in the care of this woman.

2020/3761 SII 357

Never Event- Retained vaginal swab

Root cause – Lack of understanding of importance of accurate swab counting and documentation at normal delivery.

Recommendations –

Removal of raytec swabs from delivery packs to encourage the counting of swabs that are used at delivery.

Delivery notes to change to reflect the process of counting swabs at delivery (Stamp/sticker for immediate use).

Practice development midwife to take every midwife through swab count training

Immediate drive to ensure white boards are in use during delivery.

SBARs and transfer of care

2020/16491 SII 374

Breast implant –WHO safety checklist.

Root Cause - Booking Form and the Loan Kit Equipment Booking Form

Recommendations –

All surgeons will be required to complete the booking from with a full description of the item being ordered and the appropriate item code.

Consultant training on the Johnson & Johnson online ordering portal

Pre-operation implant check between the operating surgeon and the Clinical Support Officer (CSO)

Modified Breast Implant Bank

2021/11130 SII 408 – This investigation has not yet been finalised.