Urea Breath Test Presenter: Michael Scott Hospital: Hera

1. Urea Breath TestPresenter: Michael ScottHospital: Hera 30-31 August 2006 Brisbane

2. Clinical Governance Process Overview • Clinical Safety & Quality Unit (CSQU) • Patient Safety Sub Committee • Patient Outcomes Committee • Care Improvement Program – CIP Report

3. Clinical Risk & Claims Manager Emergency Response Coordinator Trendcare Co-ordinator Clinical Safety & Quality Officers Infection Control Practitioners Clinical Safety & Quality Unit Medication Safety Officer Patient Representative Senior Clinical Risk Management Medical Officers Quality Improvement Co-ordinator Carepath Project Co-ordinators Legal Counsel DocuCube Project Officer

4. Background Information HERA Definition of Sentinel Event A serious event which resulted in: • Significant harm to the patient; and/or • Significant disappointment for the patient and/or their relatives because of unmet expectations; and/or • Risk of professional repercussions for the clinician/s; and/or • Financial or other implications for the organisation.

5. Background InformationThe Incident - Background • Patient X • 43 Years of Age • Married, Two children • Electrical Engineer • Medical Hx of stomach ulcers • Presented to Hera collection centre to undergo Urea Breath Test

6. The Process - Photographic Evidence - 1 Hyamine solution (blue) in labelled container with white top – NOT for ingestion

7. The Process - Photographic Evidence - 2 Diagnostic solution (Urea) in labelled container with yellow top – to be ingested

8. The Process - Photographic Evidence - 3 Hyamine Solution Entry point for sample Device used to receive patient’s expiratory sample

9. The Process - Photographic Evidence - 4 Entry point for sample Hyamine Solution Hyamine solution (blue) attached to sampling device circuit

10. The Incident • On 9/11/2005 patient x was inadvertently given the Hyamine solution to ingest which resulted in immediate pain and discomfort for patient. • Despite patient complaining of pain and discomfort during the test further solution was ingested as a result of advice given by staff member. • Patient left centre and proceeded home with pain and discomfort with advice to seek medical review if symptoms persisted.

11. The Incident….cont • Patient phoned HERA and upon discussing the event including ongoing symptoms with manager of Specimen Collection, patient was instructed to present immediately to A & E for medical Tx. • Review undertaken within A & E which confirmed severe burning to mouth and osphaguas with patient requiring a gastroscopy to confirm full extent of injury sustained. • Family were advised to attend from intrastate given initial concerns over prognosis.

12. The Impact to the Patient • Severe burning to mouth and oesophagus region • Loss of taste and some loss of sensation within mouth • Potential for patient to develop strictures / carcinoma • Financial costs incurred – economic loss, out of pocket expenses incurred with family flying intrastate as well as health fund excess

13. How The Event Was Reported • Clinical Safety & Quality Unit were notified via our A & E Dept within 30 minutes of patient presenting • Reporter of the sentinel event was a medical consultant • SE was reported via HERA sentinel event reporting phone line • CSQU notified hospital Executive within 1 hour of event being notified • Event details entered onto sentinel event register

14. Incident Review Process • Relevant details of the event as well as patient condition were provided by reporter. • Ascertained patient’s immediate needs in terms of medical management. • Director of relevant department was briefed in relation to the event by CSQU and asked to attend immediately to A & E in order to meet with patient and family and render an apology. • Arrangements were made for patient to be transferred to HERA private hospital under the care of a Gastroenterologist for further treatment (at no cost to patient)

15. Incident Review Process…cont • CSQU Clinical Risk and Claims Manager visited patient and family whilst still an inpatient in order to render an apology and advise what steps will be taken in terms of risk management • Offer made to patient to meet any out of pocket expenses incurred or likely to be incurred in the future • Received approval from Executive Director for RCA to be undertaken involving 2 x technical experts as well as members from CSQU

16. Incident Review Process - RCA Initial Flow Diagram (General Overview of Incident) Patient arrives at RMC for specimen collection Patient ingests Hyamine Fluid Patient goes home - GP - Wife calls Mater #8500 Patient arrives at MAH ED Patient admitted to HERA Private Hospital as inpatient RCA 01-2005 Confidential

17. Incident Review Process – RCA Initial Flow Diagram (General Overview of Incident) Q. How was the Hyamine fluid labelled / packaged? A. Blue solution, clear plastic container, white removable lid, white label with black writing – see photos Q. How was the ingestible test solution labelled / packaged? A. Clear solution, clear plastic container, yellow removable lid, white label with black writing – see photos Q. How was the test solution / Hyamine fluid checked? A. Single user check and administered Q. What sort of checklist was used? A. None Q. How were the two solutions (Hyamine / test solution) stored? A. Together – to be separated at time of administration Q. What was the physical state of the specimen collector? A. Tired / stressed at time of incident Q. How did the ingestion continue beyond patient’s initial reaction (burning sensation)? A. Lack of understanding relating to the Hyamine fluid side effects, if ingested Q. What training was provided to specimen collector? A. Supervised training Q. What competency / skill was required of the specimen collector to complete specimen collection? A. Multiple years experience with procedure, completed supervised competency testing Q. How was this incident reported / notified? A. Notified by wife of patient through #8500 (Pathology) Q. What is the need for Hyamine, specifically? A. Caustic alkaline solution (Hyamine) required to capture CO2 for testing Q. What reactions are not normally expected after ingestion of any solution provided by specimen collectors, for any test? A. Vomiting / Burning Patient arrives at RMC for specimen collection Patient ingests Hyamine Fluid

18. Incident Review Process – RCA…cont Initial Flow Diagram (General Overview of Incident) Patient goes home / visits GP / Wife calls HERA #8500 Q. What advice was given to the patient after the incident by specimen collector? A. To visit a G.P. if there were any further concerns Q. What training did the administrative officers’ have when responding to patient’s inquiries via #8500? A. Limited knowledge of specific specimen collecting techniques / tests. With appropriate information and patient questioning, inquiry can be transferred to relevant senior Pathology clinical staff Q. What advice was given to patient from #8500 (Manager of Specimen Collection Services)? A. To present immediately to HERA ED RCA 01-2005 Confidential

19. Incident Review Process – RCA…cont Initial Flow Diagram (General Overview of Incident) Q. What process facilitated an immediate review by HERA ED of the affected patient? A. After receiving transferred inquiry from Administrative Officer (through #8500) the Manager of Specimen Collection Services contacted Director of Clinical Chemistry, who in turn notified Deputy Director of HERA ED. Affected patient presented to HERA ED and was immediately reviewed by Deputy Director of HERA ED Q. What formalised process is in place to facilitate appropriate notification of incidents / affected patients to Senior Staff within Pathology Department? A. Provided inquiries are appropriately transferred to relevant senior Pathology staff, and senior Pathology staff are aware of need to escalate incident to appropriate Directors (Clinical Chemistry / HERA ED), then process proceeds Q. What was the patient told once reviewed in HERA ED? A. Deputy Director of HERA ED informed patient of probable ingestion of Hyamine fluid Patient arrives at HERA ED RCA 01-2005 Confidential

20. Incident Review Process – RCA…cont Initial Flow Diagram (General Overview of Incident) Patient admitted to HERA as inpatient Q. What harm was caused to the affected patient? A. At time of RCA, patient has suffered loss of taste sensation / oral burn Q. What are the long term effects of Hyamine fluid ingestion? A. Scarring may present up to a month later resulting in oesophageal strictures. Carcinogenic effect – possibly resulting in Squamous Cell Carcinoma RCA 01-2005 Confidential

21. Final Flow Diagram (Specific Overview of Incident) Patient arrives at RMC for specimen collection Specimen Collector collects Hyamine Fluid / Test Solution Patient ingests Hyamine Fluid Patient purchases mouth wash from Chemist Patient drives to work, burning sensation increases – goes home 1. ~0730 Hours 2. ~0735 Hours 3. ~0740 Hours 4. ~0750 Hours 5. ~0800 Hours Director of Clinical Chemistry recalls all Hyamine Fluid and restricts further related testing Manager of Specimen Collection Services contacts Director of Clinical Chemistry Director of Clinical Chemistry notified Deputy Director of HERA ED Wife of patient calls #8500 – speaks with Manager of Specimen Collection Services Patient visits G.P. 9. ~1305 Hours 8. ~1300 Hours 6. Unknown 10. ~1310 Hours 7. ~1255 Hours Director of Clinical Chemistry informs Director of Pathology and recommends reporting Sentinel Event to CSQU Patient arrives at HERA ED Patient reviewed by Deputy Director of HERA ED Director of Pathology notifies Clinical Risk and Claims Manager of Sentinel Event Deputy Director of HERA ED notifies Clinical Risk and Claims Manager of Sentinel Event 12. ~1330 Hours 13. ~1335 Hours 14. ~1500 Hours 15. ~1540 Hours 11. ~1320 Hours Patient admitted to HERA as inpatient Patient still in HERA ED under observation Potential Barrier Point 17. ~1800 Hours 16. ~1730 Hours

22. Cause and Effect Diagram Contributing Factor Storage of hyamine solution Staff member did not separate hyamine solution from ingestable test solution Hyamine solution / ingestible test solutions are delivered attached (rubber-banded) to each other and stored within fridge WHY WHY Contributing Factor Labelling of hyamine solution Staff member did not recognise difference in labelling of hyamine solution and ingestible test solution Labelling of hyamine solution / ingestible test solution similar (Black and white label), with no warnings / alerts visible WHY WHY Contributing Factor No checking process for hyamine solution Staff member did not check both solutions prior to administration No checklist / checking process utilised with hyamine solution and ingestible test solution WHY WHY Problem Statement Hyamine Ingestion Contributing Factor Similar container used for hyamine solution and ingested test solution Staff member did not recognise different containers for hyamine and ingestible test solution Both hyamine / ingestible test solution prepared and delivered in similar clear, plastic containers WHY WHY Contributing Factor Knowledge / recognition of effects of hyamine ingestion Staff member did not recognise signs / effects of hyamine ingestion Infrequent training in relation to usage of hyamine solution and an absence of signage / alerts warning of effects of hyamine ingestion No checklist to assess patient condition post test No flowchart / algorithm to indicate actions / notifications required if hyamine ingested WHY WHY Contributing Factor Initial treatment, advice and notification of hyamine ingestion Staff member did not initiate appropriate first aid or advice to patient and did not notify MHS in relation to incident WHY

23. Incident Review Process - Summary • RCA commenced within 14 days of event occurring • RCA concluded within 45 days of event occurring • RCA action plan formulated which identified 11 key recommendations to be undertaken. • 100% of recommendations has been actioned within allotted timeframe

24. Key findings and recommendations – The key findings and recommendations included: • Hyamine and ingestible test solution (urea) should not be stored together • Hyamine solution should not be stored within patient areas • Hyamine solution should be clearly and appropriately labelled i.e. POISON / FLAMMABLE / NOT FOR INGESTION / DIFFERENT COLOURED LABEL • A pre-test checklist (requiring two person checking) should be developed • Pathology department should explore the introduction of an ingestible Urea Capsule (not solution) as per TGA recommendations

25. Key findings and recommendations – The key findings and recommendations included: • Staff training for specimen collection should be at least annually and mandatory • A list of current tests (including Urea Breath Testing) and their potential adverse outcomes should be developed to increase staff awareness • Current post-test check list should be incorporated into a revised checklist that offers trigger points to assess patient and initiate appropriate first aid

26. Key findings and recommendations – The key findings and recommendations included: • A handout letter should be provided to patients after Urea Breath Testing to advise them of general adverse reactions and to notify hospital / their GP and / or HERA pathology reception (#8500) • Urea Breath Testing should not be performed by staff outside of their ability or tested competency • The length of time deemed acceptable between staff competency assessments with testing (Urea Breath Testing) should be reviewed

27. Closing the loop Describe the outcome – what was done/implemented, how processes have now changed? • Hyamine now stored separately • Hyamine now stored out of patient areas • Revised labels for containers of Hyamine solution • Developed pre-test checklist

28. Closing the loop…cont Describe the outcome – what was done/implemented, how processes have now changed? • Pathology department approached relevant companies to ascertain feasibility of alternate methods for ingestion • Allocated dedicated staff trainer to facilitate annual staff education requirements and competencies • List developed for potentially harming tests and their respective adverse outcomes

29. Closing the loop… cont Describe the outcome – what was done/implemented, how processes have now changed? • Developed post-test checklist • Developed patient handout / letter • Urea Breath testing is now only performed on HERA campus • Pathology department incorporated into training staff competency based testing

30. Closing the loop…for the patient /staff • Apology (open disclosure) provided to patient and family • Copy of RCA was provided to patient • Financial commitment provided to patient in relation to the event • Regular phone calls to patient since event in order to gauge progress • Incident discussed with staff member and support provided

31. Open Issues What still needs to be fine-tuned or improved in regard to the above incident? • Currently reviewing all key processes within Pathology Dept – Specimen Collection and other phases

32. Lessons Learnt • All other testing solutions (ingestible / non-ingestible) used within Pathology department should be reviewed to determine whether they are clearly and appropriately labelled • Continue review of locations where Urea Breath Testing is undertaken and consult Clinical Safety and Quality Unit if further risk assessment required • Review the length of time deemed acceptable between staff competency assessments with specimen collection / testing (other than Urea Breathing Testing) • Other known tests that may cause severe adverse reactions (permanent harm) should be listed and risk assessed to determine process weaknesses that may result in a clinical incident e.g. 24 Urine Collection Testing • Store the solution separately • Ensure solution containers were properly labelled