Software and Patient Safety

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Can Software Enhance Patient Safety? Software and Patient Safety

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Safety is complex, no simple solutions ‘A Human Activity System’ Safety Risk is NEVER zero

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Risk to a worker in a relatively high risk industry such as mining 1 in 1000 per person year Risk of death in a Road traffic accident 1 in 10,000 per person year Risk of death in a Rail traffic accident 1 in 60,000 per person year Risk of death in an industrial accident in the very safest parts of industry 1 in 100,000 per person year Risk of death in a Air traffic accident 1 in 3,000,000 per person year Risk (of death) broadly accepted by the UK population

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Safety Critical Or Safety Related? AC Software

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4 incidents reported that have been confirmed to have led to a death 12 incidents confirmed to have led to severe harm NPSA - National Reporting and Learning System (NRLS) – 1 January 2007 and 31 January 2008 http://www.npsa.nhs.uk/corporate/about-us/foi/informationlog/?EntryId51=62001. Incidents from NPSA

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Near Misses and Unsafe Acts

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Patient lost in system for 5 Months – no harm Patient given 1 week test interval when unstable – INR 8 – no harm Zero INRs entered – software used wrong last dose – no harm Patient with High INR on Vitamin K – with two interval – DNA’d and given one week interval – no harm Some Software Related Near Miss Incidents

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Main Sources of Incidents Interfaces and Transitions Admission/Discharge/Induction/Bridging/Wrong Continuation/Boost and Miss Days/Stopping not restarting/Extended Holidays/Too long a Test Interval Monitoring & Follow-up Failure Wrong dose and Test Interval, who is doing it Confusion Alternate day dosing/Ambiguous Instructions/Tablet size 0.5 or 5mg/Tablets per day/mg per day Automation System does things behind the scenes

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Need to segregate patients who are Unstable and in Transition and treat them individually

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Impossible for Programmers to foresee exactly how each user will use the system in certain situations Safety of Software Balance Flexibility/New Options with Safe Operation

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Feeling among non-software professionals that software will not or cannot fail, which leads to complacency and over reliance on computer functions Overconfidence in Software

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Normal systems: 1/100 to 1/1000 uses To achieve 1/10000 considerable extra effort is needed. To achieve 1/1000000 this additional effort has to be as great as the initial development effort Software Error Rates ( Kletz T. Computer Control and Human Error 1995)

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Human Errors Rates (Leveson N Safeware 1995) 1 in 100 to 1 in 300 Tasks

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Fault Tree – Giving Patient Incorrect Dose Instruction

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Totally Manual Clinic - 1 in 7 Computer Manual Printing – no checks - 1 in 10 Computer Manual Printing – w. checks - 1 in 6000 Computer Automated Printing - no checks - 1 in 17 Computer Automated Printing – w. checks - 1 in 11000 Risks with Software Mishaps /Patient Year

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Risk to a worker in a relatively high risk industry such as mining 1 in 1000 per person year Risk of death in a Road traffic accident 1 in 10,000 per person year Risk of death in a Rail traffic accident 1 in 60,000 per person year Risk of death in an industrial accident in the very safest parts of industry 1 in 100,000 per person year Risk of death in a Air traffic accident 1 in 3,000,000 per person year Risk (of death) broadly accepted by the UK population

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Customer Risk Control System?

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DAWN Risk Control System

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Total Risk Control System

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Learning from the Past ‘Organisations have no memory’ Safety Notices http://www.4s-dawn.com/DAWNSafetyNotices.htm Safety Management Largely about learning from incidents Detect weak signals – e.g. near misses and Respond vigorously & rigorously

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PREVENT And DETECT Carry out a FMEA

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Making things simpler and building systems that are intellectually manageable Most Effective Tool

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Visibility Feedback Mapping Sequencing Reversibility Design of Everyday Things Principles

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HRO – High Reliability Organisations They: Detect weak signals – e.g. near misses And Respond vigorously & rigorously

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Establish Routine Key Checks and Balances For example – Each day look for Large dose changes including miss and boost doses in recent past (>20%?) Large interval changes ( >100%?) Patient’s with no next test date

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For Stable Patients only Next Dose depends on correct Last Dose Need two previous stable doses for dose recommendation Maintenance Module

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The safety of a piece of software cannot be evaluated by looking at the software alone – it’s part of a human activity system Is the software being used as intended? Safety of Software

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Minimise (handle one patient at a time instead of batches, separate out high risk patients from low risk, prevent and be alert to backlogs building, focus on patients in transitions/across interfaces) Simplify (fewer steps and options) Inherently Safer Design

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THE SOFTWARE SHOULD BE SEEN AS AN AID TO THE HEALTHCARE PROFESSIONAL . IT IS A CONDITION OF USE THAT ALL INSTRUCTIONS OR INFORMATION ISSUED BY THE SOFTWARE ARE CHECKED BY A COMPETENT HEALTHCARE PROFESSIONAL BEFORE INSTRUCTING THE PATIENT . FURTHERMORE, THE LICENSEE SHALL OPERATE THE SOFTWARE IN COMPLIANCE WITH THE WRITTEN RECOMMENDATIONS CONTAINED IN THE LICENSOR'S SAFETY AND USER DOCUMENTATION A COPY OF WHICH HAS BEEN PROVIDED TO LICENSEE. Excerpt from DAWN Software Licence Agreement

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All dosage and test interval advice printed or issued from the computer must be reviewed by an experienced healthcare professional before being given to the patient. The customer must have a procedure to ensure rigorous follow up of non attendees and ensure that all patients have a next test date. To operate the system successfully, a computer literate person is required .  This person should be able to drive application programs, manipulate the PC operating system, for example to copy files and backup the data held on the PC. The customer must ensure that only personnel that have been adequately trained in the use of the software and the safety instructions to operate the system. The customer must operate the system in accordance with the Anticoagulation Safety manual. Prior to initial use and following any software upgrade or change to the software settings , a thorough validation exercise of the software should be completed for your local way of working before ‘live’ operation. This shall include a test of dose instructions and test intervals covering the full ranges of INRs. Records of the results of the validation shall be maintained. The validation will be authorised by the lead clinician/physician. It is vitally important that the customer site establishes a robust method of backing up and restoring their data, including occasional tests of the backups through restoration, at an appropriate interval. Usually this is at the end of each working day. If there is a lot of system activity a more frequent back-up procedure should possibly be considered. The customer should notify 4S immediately if they notice any anomalies within the data or experience anything within the system that could potentially cause a mishap . Customer Obligations

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Competent Healthcare Professional MLA AC3 BMS 1 BMS 2 CNS Pharm Cons increasing competency 5 4 3 2 1 demographics book checks and release simple dosing complex dosing clinical problems

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Signals Passed at Danger Since Introduction of automatic train protection and warning system (TPWS) – SPAD incidents greatly reduced

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ALL INSTRUCTIONS OR INFORMATION ISSUED BY THE SOFTWARE ARE CHECKED BY A COMPETENT HEALTHCARE PROFESSIONAL BEFORE INSTRUCTING THE PATIENT

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Generating Lapses INCORRECT The task is not carried out correctly NO,NOT,NONE The task is not carried out or fails or stops MORE OF More of the task can be carried out than should be. LESS OF Less of the task can be carried out than should be. PART OF Incomplete performance of task REVERSE Something happens backwards OTHER(THAN) The operator presses the wrong button AS WELL AS Another task occurs as well as the planned task SOONER/LATER THAN A task is completed at the wrong time relative to others OUT OF SEQUENCE Tasks are done in the wrong order TRANSITIONS Ie Moving from 1 state to another NON-STANDARD/NOT DESIGNED FOR Could this task be done in a non-standard way, eg use maintenance dosing instead of induction dosing.

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Near Misses and Unsafe Acts Near Misses and Unsafe Acts

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Negligible Marginal Critical Catastrophic Likely B B A A Possible C B B A Unlikely C B B B Very Unlikely C C B B Risk ALARP Matrix B= As Low as Reasonably Practicable (ALARP) – risk outweighed by the benefit? – Add Safeguards C= Broadly Acceptable A= Intolerable – Redesign - look around for a new solution or an alternative way

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Risk ALARP Matrix Negligible Marginal Critical Catastrophic Likely Possible Unlikely Very Unlikely Severity Definition Catastrophic Potential for Multiple deaths/ incapacitating events Critical Potential Single Death/ Single incapacitating events Marginal Potential for incapacitating events Negligible Little or no potential for incapacitating events Likelihood of Event Definition Likely Happened before or something similar before Possible It has not happened before but COULD Unlikely It could happen in exceptional circumstances Very Unlikely No suggestion that harm will occur at all

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A hazard is something that has the potential to cause harm. A risk is the likelihood of the potential hazard being released and causing damage or injury. A control or safeguard is a recommended or prescribed way of carrying out the work that, if followed, should reduce the risk. Definitions Definitions

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“Patient discharged on Warfarin with no information to GP. Patient not told to reduce Warfarin dose. INR checked by staff member and was >10.” “Patient was on warfarin and stopped on admission due to risk of bleed. Patient sent home with dossette box with aspirin in, but son gave warfarin in addition to dossette box. Patient was re - admitted with melaena, perforated viscus and died.” “Patient on warfarin. INR reading on [date] was 6.6. Patient taken ill with "coffee ground" vomiting and died in [hospital name] on [date]. Omitted warfarin for one day, then reduced her current dose. Patient was due for recheck of INR [date]”. “Patient was prescribed 5mg OD of warfarin instead of 3mg OD from [3 day date period]. Patient fell and died a few hours later from a suspected retroperinneal bleed. Two INRs checked on [date] were 6.8 and 8.1” Incidents from NPSA

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“Patient discharged from surgical ward after surgery, usually on warfarin. On discharge told to take 3mg / 4mg alternate days (Prescription as 3 - 4mg daily). Patient misunderstood and took 3mg mane and 4mg nocte. Unsure whether this was written in anticoagulant book or not. Admitted [date] with INR 16.7 requiring reversal with IV Vitamin K”. “Patient discharged home without informing the anticoagulation team. Patient discharge home on 7mg of warfarin. He usually takes 5mg Monday to Friday and 4mg on a weekend. Patient took 3 days of 7mg and warfarin before contacting the anticoagulation office”. “Patient phoned practice looking for new strength of warfarin. Receptionist put note for GP on system. GP checked record and prescribed 5mg tablets. Should have been 0.5mg tablets - either patient or receptionist didn't know it should have been 0.5mg tablets. Previously had 5mg tabs in the past. Patient took high strength and ended up with INR of 11+ admitted to hospital”. “Dr [Staff Name] - Gentleman on Warfarin for DVT / embolic events. Stopped as had haematuria. Asked and wrote in notes for Warfarin to re - start and it was not given. He had checked pain 03:00. During the morning none of his angina medication and developed L arm symptoms. Had a troporin check which was 0.06, indication of a small M.I. as a result of not receiving medication.” “Patient admitted on [date] taking life long warfarin for DVT and bilateral PE. Warfarin was listed under drugs in notes but admitting Dr did not prescribe on chart. Not given for 8 weeks. Patient asked nursing staff on [date] why he wasn't receiving it anymore. Patient wasn't on fragmin on admission”. Severe Harm Example Incidents

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While there are many SPADs each year, most of these have little or no potential to cause harm because they are the result of minor misjudgements of distance or of braking capability, or they occur at low speed. In most cases, the trains stop within the safety overlap provided at the signal. The overlap is a clear section of track beyond the signal, usually 183 metres long, which provides protection against relatively minor overruns. Generally, trains have to run past the signal safety overlap before there is any potential of collision or derailment. Can SPADS cause accidents? SPADs are only one of the potential precursors to catastrophic accidents on the railway. Under 3% of all train collisions and derailments over the last 30 years have been directly caused by SPADs.  Since the introduction of the train protection and warning system (TPWS) serious SPAD incidents, and the risk arising from SPADs have been greatly reduced. SPADS

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TRANSPORT MODE 1992 - 2001 AVERAGE Air 0.01 Rail 0.4 Car 3 Offshore Helicopter 4.33 Pedal Cycle 42 Pedestrian 58 Two Wheeled Motor Vehicle 106 Comparison of Average Passenger Fatality Rates per Billion Passenger Kilometres by Transport Mode 1992 to 2001

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Table 1: Summary of Calculated Human Error Probabilities Task Description Calculated HEP Comments High change in INR not noticed 0.0018 Wrong Instruction Generated 0.0042 Patient Records Transposed 0.0055 ‘Manual Only’ Clinic Independent Check 1 Assumed that no independent check available High change in INR not noticed 0.00083 Improvement over manual only because software issues warning Wrong Instruction Generated 0.00083 Improvement over manual only because software issues warning Patient Records Transposed Hand written Single label Many labels 0.0068 0.0055 0.0065 Applies to error of ‘sticking label in wrong book’ ‘Software Interpretation’ and manual printing Independent Check 0.0015 High change in INR not noticed 0.00083 As for manual printing case Wrong Instruction Generated 0.00083 As for manual printing case Patient Records Transposed 0.0024 ‘Software Interpretation (and automated printing Independent Check 0.0015 As for manual printing case

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Independent Check 0.0015 High change in INR not noticed 0.00083 Improvement over manual only because software issues Hand written Single label Many labels 0.0068