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Cardiothoracic and Vascular Surgery Risk Assessment: Patient Safety, Team Competence and Continuity Controls

A worked example of how a cardiothoracic and vascular surgery service finds, scores and controls risks to patients, teams, equipment, devices, records and continuity of operating lists.

Updated November 2026 8 hazards assessed Review every 6 months Highest risk: Critical to Medium
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Executive summary

This assessment shows how a cardiothoracic and vascular surgical service can find, rate and control the risks that matter most to patients and teams. Eight risks were chosen because they are plausible in planned and emergency surgery, device use, intensive care handover and supply. Bleeding or circulation failure and retained items carry the highest natural scores, while cyber interruption and supply shortfalls are less likely but disrupt many operations at once. Each risk is scored before controls and again after existing and added controls. Most risks fall to Medium or Low once added controls are in place, but bleeding and circulation failure stay Medium because the impact remains severe. The first actions are a structured time-out before every incision, a device traceability check, a competence sign-off for emergency lists and a tested downtime plan. This is a teaching example, so every score illustrates method and needs specialist clinical review before any real use.

Focus area
Cardiothoracic and vascular surgery
Setting
Hospital cardiac, thoracic and vascular surgical service with operating rooms, perfusion support and intensive care handover
Method
Five by five likelihood and impact risk register

Scope

This assessment covers a hospital cardiothoracic and vascular surgical service, from pre-operative assessment and operating room work to intensive care handover, device use and follow-up. It looks at risks to patient safety, team competence, equipment, records, supply and service continuity. It does not cover clinical decision making for any individual patient. Jurisdiction, hospital size, staffing model and information systems are assumptions made for teaching.

Context

The service runs planned and emergency operating lists with surgeons, anesthesia staff, perfusionists, operating room nurses, intensive care staff and imaging teams. Implants, extracorporeal circulation equipment, monitoring devices and blood products are sourced from suppliers and managed through the hospital pharmacy and blood bank. Patient records, imaging and consent forms sit in an electronic record with some paper documents. Each risk is scored before controls to show its natural level, then again after existing controls and the additional controls that should be added. Ratings are teaching aids and need specialist clinical review.

Objectives, assets and stakeholders

The objective is to deliver safe, timely cardiothoracic and vascular surgery, protect patients from avoidable harm, keep teams competent and supported, and maintain trust with patients, referring clinicians, regulators and the public. Assets in scope are patients, operating rooms and perfusion equipment, implants and devices, blood and medicines, clinical records and imaging data, and the skilled workforce. Stakeholders include patients and families, surgeons, anesthesia staff, perfusionists, nurses, intensive care teams, the hospital board, suppliers, the quality and safety committee and regulators. Every risk has one owner role, and the clinical director keeps the register current and reports to the quality committee each quarter.

Risk matrix: before and after controls

Each cell shows hazard numbers placed by likelihood and impact. Compare the two grids to see how controls move each hazard.

Before controls

Inherent risk

Risk before controls: rows are likelihood from almost certain to rare, columns are impact from insignificant to catastrophic. Cells list hazard numbers.
1
Insignificant		 2
Minor		 3
Moderate		 4
Major		 5
Catastrophic
5 Almost certain
4 Likely Likelihood 4, impact 5, score 20, critical: H03
3 Possible Likelihood 3, impact 4, score 12, high: H04 H05 Likelihood 3, impact 5, score 15, high: H01
2 Unlikely Likelihood 2, impact 4, score 8, medium: H07 H08 Likelihood 2, impact 5, score 10, high: H02 H06
1 Rare

After controls

Residual risk

Risk after controls: rows are likelihood from almost certain to rare, columns are impact from insignificant to catastrophic. Cells list hazard numbers.
1
Insignificant		 2
Minor		 3
Moderate		 4
Major		 5
Catastrophic
5 Almost certain
4 Likely
3 Possible
2 Unlikely Likelihood 2, impact 2, score 4, low: H07 Likelihood 2, impact 3, score 6, medium: H01 H04 H05 H06 Likelihood 2, impact 4, score 8, medium: H02 H03
1 Rare Likelihood 1, impact 4, score 4, low: H08
  • Low 1 to 4
  • Medium 5 to 9
  • High 10 to 16
  • Critical 17 to 25

Hazard register

A summary first, then the detail for each hazard.

Summary of hazards with scores before and after controls
No.HazardBeforeAfterOwner
H01 Retained item or miscount at wound closure 15 High 6 Medium Operating theatre manager
H02 Wrong site, wrong patient or wrong procedure 10 High 8 Medium Clinical director
H03 Major bleeding or extracorporeal circulation failure 20 Critical 8 Medium Head of perfusion
H04 Competence and cover gaps on emergency lists 12 High 6 Medium Clinical services manager
H05 Implant and device traceability failure or recall 12 High 6 Medium Supply chain lead
H06 Cyber attack or record failure disrupting schedules and imaging 10 High 6 Medium IT and information security manager
H07 Loss of theatre capacity, blood or critical supplies 8 Medium 4 Low Business continuity lead
H08 Consent, documentation and adverse event reporting lapses 8 Medium 4 Low Clinical governance lead
H01

Retained item or miscount at wound closure

Safety Before 15 After 6

A sponge, swab, instrument or small component is left in the patient after closure, or counts do not reconcile and no one records the discrepancy, which can cause infection, reoperation or serious harm.

Who or what is affected: Patients, operating team and intensive care staff

Causes

Long or complex cases, interruptions during counts and counts done quickly under pressure.

Consequences

Retained item, infection, reoperation, complaint and legal claim.

Existing controls

  • Instrument and swab counts are recorded on a board at closure.
  • Team members confirm counts aloud before the wound is closed.

Control gaps

Counts depend on memory and verbal confirmation, and imaging checks are not always used when counts differ.

Additional controls

  • Prevent: Use tagged swabs and a standard count sequence for every case.
  • Detect: Require an imaging check when a count does not reconcile.
  • Respond: Stop closure and inform the surgeon until the discrepancy is resolved.
Likelihood 3 x impact 5 before; 2 x 3 after Owner: Operating theatre manager Target: Within 30 days Early warning: Count discrepancy or unexplained retained item alert at closure.
H02

Wrong site, wrong patient or wrong procedure

Safety Before 10 After 8

Surgery starts on the wrong side, body site, patient or procedure because identity checks, marking or the time-out are incomplete or rushed, leading to unnecessary harm.

Who or what is affected: Patients, surgeons and the operating team

Causes

Rushed lists, changes to the plan on the day, unclear marking and communication gaps between teams.

Consequences

Unnecessary surgery, further operation, serious harm, legal claim and loss of trust.

Existing controls

  • Patient identity is checked against the list before anesthesia.
  • Surgical site is marked and checked against the consent form.

Control gaps

Time-outs are sometimes rushed or completed by one person, and changes to the plan are not always rechecked.

Additional controls

  • Prevent: Run a structured time-out before incision with every team member speaking.
  • Detect: Audit a sample of time-out records against the signed consent.
  • Recover: Disclose the event promptly and review the case in a learning review.
Likelihood 2 x impact 5 before; 2 x 4 after Owner: Clinical director Target: Within 30 days Early warning: Time-out checklist incomplete or not recorded for a case.
H03

Major bleeding or extracorporeal circulation failure

Safety Before 20 After 8

Bleeding during or after cardiac or vascular surgery, or failure of the heart-lung machine, pumps, oxygenator or monitors, can cause rapid deterioration and death if not managed at once.

Who or what is affected: Patients, surgeons, perfusionists and intensive care staff

Causes

Complex anatomy, fragile tissue, clotting disorders and mechanical or software faults in equipment.

Consequences

Hemorrhage, organ injury, emergency reoperation and death.

Existing controls

  • Pre-operative blood and clotting tests guide the surgical plan.
  • Perfusion equipment is serviced and checked before each list.

Control gaps

Backup equipment is not tested under live conditions, and some alarm limits are left at factory defaults.

Additional controls

  • Prevent: Keep an agreed massive transfusion protocol and check blood stock before each list.
  • Detect: Use a pre-bypass checklist and continuous monitoring with defined alarm limits.
  • Respond: Rehearse equipment failure and backup pump routines every quarter.
Likelihood 4 x impact 5 before; 2 x 4 after Owner: Head of perfusion Target: Within 45 days Early warning: Unplanned increase in blood use or repeated alarm events during a case.
H04

Competence and cover gaps on emergency lists

People Before 12 After 6

Emergency and out of hours lists are staffed with perfusion, anesthesia or theatre staff who lack recent experience with complex cases or have not had recent competence checks, so errors and delays become more likely.

Who or what is affected: Patients, staff and on-call teams

Causes

Small specialist teams, long on-call hours and uneven training records.

Consequences

Delayed care, avoidable errors, staff burnout and reduced service capacity.

Existing controls

  • Rotas name a senior lead for each emergency list.
  • Staff complete annual training in resuscitation and equipment use.

Control gaps

Competence records are not linked to the rota, so gaps are found late.

Additional controls

  • Prevent: Require competence sign-off for each role before rostering to emergency lists.
  • Detect: Review fatigue and cover gaps monthly against the rota and case mix.
  • Respond: Escalate to the on-call consultant when cover cannot be confirmed.
Likelihood 3 x impact 4 before; 2 x 3 after Owner: Clinical services manager Target: Within 60 days Early warning: Emergency list staffed with a role that has no current competence sign-off.
H05

Implant and device traceability failure or recall

Supplier Before 12 After 6

Implants, valves, grafts or catheters cannot be traced to the patient, or a supplier recall or product fault is not identified in time, so affected patients are not found quickly.

Who or what is affected: Patients, device teams, suppliers and regulators

Causes

Manual records, multiple suppliers and recall notices that arrive by post or email.

Consequences

Delayed patient alert, further surgery, safety harm and regulatory action.

Existing controls

  • Device stickers are placed in the patient record after each implant.
  • Suppliers are asked to notify the hospital of recalls.

Control gaps

Recall notices are not always logged centrally, and stock is not matched to patients.

Additional controls

  • Prevent: Scan device identifiers into the record before each implant is opened.
  • Detect: Check the recall register weekly and match it against stock and past implants.
  • Recover: Contact affected patients through a tested recall procedure.
Likelihood 3 x impact 4 before; 2 x 3 after Owner: Supply chain lead Target: Within 45 days Early warning: Implant used without a recorded traceable identifier.
H06

Cyber attack or record failure disrupting schedules and imaging

Technology and data Before 10 After 6

A ransomware attack, phishing or failure of the record or imaging system stops access to operating schedules, consent forms, pre-operative results and images, so cases are delayed or decisions are made without key data.

Who or what is affected: Patients, surgical teams and records staff

Causes

Phishing, reused passwords, outdated systems and external connections.

Consequences

Cancelled cases, unsafe decisions, data breach and regulator interest.

Existing controls

  • Access to the record requires individual log in and role based rights.
  • Data is backed up each night to a separate location.

Control gaps

Downtime forms are not held in every operating room, and restore tests are rare.

Additional controls

  • Prevent: Enable multi-factor sign in and train staff to spot phishing each year.
  • Detect: Monitor unusual access and failed log ins and alert the security team.
  • Recover: Test restoring schedule and imaging records and keep paper downtime forms ready.
Likelihood 2 x impact 5 before; 2 x 3 after Owner: IT and information security manager Target: Within 30 days Early warning: Repeated failed log in attempts or unusual access to surgical records.
H07

Loss of theatre capacity, blood or critical supplies

Operational Before 8 After 4

Blood products, critical medicines or theatre capacity fall short because of supplier failure, equipment breakdown or a sudden rise in demand, so planned cases are postponed or emergency cases wait.

Who or what is affected: Patients, theatre staff and the blood bank

Causes

Single source supply, transport delay and unexpected emergency demand.

Consequences

Cancelled operations, worse patient outcomes and reputational harm.

Existing controls

  • Minimum stock levels are set for blood and critical medicines.
  • Two suppliers are approved for key consumables.

Control gaps

Standby supply has not been tested, and theatre rescheduling depends on named people who are not always available.

Additional controls

  • Prevent: Hold a standby order with a second source for critical items and review it quarterly.
  • Respond: Activate the standby theatre plan and reschedule non-urgent cases.
Likelihood 2 x impact 4 before; 2 x 2 after Owner: Business continuity lead Target: Within 60 days Early warning: Blood or critical medicine stock below the agreed minimum level.
H08

Consent, documentation and adverse event reporting lapses

Legal and compliance Before 8 After 4

Consent is taken without full information or recorded poorly, or adverse events are not written up and reported in time, so patients lack informed choice and the service cannot learn from harm.

Who or what is affected: Patients, families, clinicians and regulators

Causes

Time pressure before surgery, complex options and unclear reporting duties.

Consequences

Legal claims, patient distrust, disciplinary action and missed learning.

Existing controls

  • Consent forms are signed before each planned operation.
  • Adverse events are reported through an internal incident system.

Control gaps

Consent audits are occasional, and incident reports are not checked against actual events.

Additional controls

  • Prevent: Use a standard consent discussion with risks and alternatives recorded for each case.
  • Detect: Audit a sample of consent records and incident reports each month.
  • Respond: Hold a learning review and inform the patient within agreed timeframes.
Likelihood 2 x impact 4 before; 1 x 4 after Owner: Clinical governance lead Target: Within 90 days Early warning: Consent forms incomplete or incident reports not submitted within the agreed time.

Rating method and evaluation

Each risk is rated on two five-point scales. Likelihood runs from 1, rare, to 5, almost certain in this service. Impact runs from 1, minor, to 5, catastrophic, and includes harm to patients, delay to surgery, cost, legal exposure and loss of trust. Multiplying the two gives a score from 1 to 25, which falls into one of four bands: Low from 1 to 4, Medium from 5 to 9, High from 10 to 16 and Critical from 17 to 25. Inherent risk is the score before any controls. Residual risk is the score after existing and added controls, and it must never be higher than the inherent score. Where inherent is 10 or more, residual must be lower. Patient harm is never rated down only because it has not happened yet. Critical and High risks need senior clinical and executive attention with a dated plan, Medium risks need routine controls with a named owner, and Low risks are accepted and watched. Surgeons, anesthesia and perfusion staff, nurses and a patient safety representative challenge the scores, and each risk is reviewed whenever an indicator reaches its threshold or after a significant event. The scores guide the order of work and are not a measure of clinical quality.

Likelihood, impact and rating bands

Likelihood

  • 5 Almost certain: Expected to happen in most circumstances.
  • 4 Likely: Will probably happen in many circumstances.
  • 3 Possible: Could happen at some time.
  • 2 Unlikely: Not expected, but it could happen.
  • 1 Rare: Only in exceptional circumstances.

Impact

  • 1 Insignificant: No lasting effect. Handled within routine work.
  • 2 Minor: Small effect that is quickly corrected.
  • 3 Moderate: Noticeable effect that needs managed effort to correct.
  • 4 Major: Serious effect on people, delivery or reputation.
  • 5 Catastrophic: Severe or lasting effect that threatens the whole activity.

Bands (likelihood x impact)

  • Low (1 to 4): Accept and monitor.
  • Medium (5 to 9): Manage with routine controls.
  • High (10 to 16): Senior attention and a treatment plan.
  • Critical (17 to 25): Act first. Do not proceed until reduced.

Monitoring, escalation and review

Review this assessment every 6 months, and sooner when an indicator below reaches its threshold.

Early-warning indicators and escalation thresholds
Indicator to watchEscalate when
Count discrepancies or unexplained retained item alerts at closure.Escalate to the clinical director at once, pause further closures until resolved, and inform the patient safety lead the same day.
Implants used without a recorded traceable identifier.Escalate to the supply chain lead within one working day, and to the quality committee if more than one case occurs in a month.
Surgical sessions where the time-out checklist is incomplete or not recorded.Escalate to the operating theatre manager after any gap, and to the clinical director if gaps recur within a month.
Perfusion or anesthesia cover gaps on emergency lists.Escalate to the head of perfusion or the anesthesia lead at once, and postpone non-urgent cases if cover cannot be confirmed.
Critical blood or device stock below agreed minimum levels.Escalate to the blood bank lead or supply chain lead when stock falls below the minimum, and to the hospital executive if not restored within 24 hours.

Contingency arrangements

If a serious event occurs, such as a retained item, wrong site procedure, major bleeding or device failure, the operating team pauses the list, delivers immediate clinical care and follows the local emergency escalation route. The clinical director informs the patient, the family and the risk team, and preserves records and equipment for review. Surgical activity is moved or suspended if theatre capacity, perfusion cover or blood supply is lost, and the standby theatre plan is started. Regulators and insurers are informed through the patient safety lead as required in the relevant jurisdiction.

Prioritized action plan

  1. Use a standard pre-operative checklist and team time-out before every incision, owner clinical director, within 30 days.
  2. Confirm counts for swabs, instruments and sponges at closure and record them, owner operating theatre manager, within 30 days.
  3. Check device traceability and recall alerts before each implant, owner supply chain lead, within 45 days.
  4. Run a competence review for perfusion and anesthesia cover on emergency lists, owner head of perfusion, within 60 days.
  5. Test the downtime and standby theatre plan, owner business continuity lead, within 90 days.

Conclusion

Safe cardiothoracic and vascular surgery rests on a few steady habits: structured checklists at every stage, clear team communication, traceable devices, competence checks, and tested plans for failure of equipment, supply or systems. The highest natural scores sit with bleeding, retained items and wrong site events, and each has controls that bring residual risk down. Treat the register as a living record, review it on the stated cycle, and seek specialist clinical and legal advice for any real decision about care, device use or regulation.

Assumptions and limitations

Assumptions

  • Jurisdiction and hospital governance are not specified, so legal and regulatory duties are described in general terms only.
  • Staff hold recognized training and credentials, and specialist review is needed for all clinical decisions.
  • Implant, device and blood product supply comes from several suppliers, with a standby source for critical items.

Limitations

  • The scores are teaching examples and do not describe any real hospital or patient group.
  • Clinical practice changes over time, so specialist clinical review is needed before any use of this content.
  • This is educational content and does not replace a formal site-specific risk assessment or licensed clinical advice.

Related frameworks to study

  • Hierarchy of controls
  • Clinical governance cycle
  • Three lines model of risk ownership
  • Root cause analysis
  • Systems approach to patient safety

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For Learning Reference Only: This assessment demonstrates how risk assessment principles are applied in a practical setting, providing a useful reference for learning and understanding. Actual assessments may be adapted to suit specific site conditions and circumstances.

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