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Hong Kong West Cluster announces investigation report on heart transplant incident
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The following is issued on behalf of the Hospital Authority:

     The spokesperson of Hong Kong West Cluster (HKWC) today (July 25) announced the findings of the Investigation Panel regarding an incident of heart transplant with incompatible blood types. HKWC announced the sentinel event on the day of the incident and subsequently set up an independent panel to investigate the incident.

     On May 20, 2013, the Cardiac Medical Unit (CMU) of Grantham Hospital (GH) was informed by the Organ Transplant Co-ordinator of Queen Elizabeth Hospital of the availability of a cadaveric heart from a deceased patient of blood group AB. A critically ill 58-year-old female patient, with blood group A and end-stage heart failure, was identified by the CMU team as most urgently in need for a life-saving heart transplant operation. The patient was transferred to the cardiothoracic surgical team of Queen Mary Hospital (QMH) in preparation for a heart transplant operation to be conducted in the morning of May 21. The operation was conducted by the cardiothoracic surgical team. Towards the end of the operation, a CMU nurse from GH called back to alert the CMU team and the QMH cardiothoracic surgical team to the blood group incompatibility.

     Intensive desensitisation was initiated immediately after the operation and the patient did not show any sign of acute rejection. The incident was disclosed to the family immediately following the operation and to the patient subsequently as she progressively recovered.

     QMH reported the incident to the Hospital Authority (HA) Head Office and an Investigation Panel was set up to identify the causes of the incident and make recommendations for improvement.

     The investigation has been completed and the report has been submitted to the HA Head Office. HKWC regrets the incident and has explained to the patient and her family the investigation results. The patient is now in stable condition with no signs of rejection. She is undergoing post-heart transplant rehabilitation training and is planned to be discharged within weeks. HKWC wishes to express deep apologies once again to the patient and her relatives and would take responsibility for this unintended incident.

     The Panel identified several critical control points where safety checks should be adopted to ensure blood group compatibility between donor and recipient. These are:

- At the point of receiving the "Organ donor record form" from the Organ Transplant Coordinator (OTC) after confirming the Brain Death Test of the potential donor;
- During recipient selection;
- At organ procurement;
- At the recipient's admission; and
- In the operation room when "Time Out" is conducted.

     The Panel noted the communication between the OTC and the Heart and Lung Transplant Coordinator (HTC) required a lot of phone communication and written documentation so as to make accurate donor assessment. The Panel opined that direct access to the donor information by the transplant teams may prevent occurrence of communication and transcription errors during the phone and fax communication.

     The Panel observed that during recipient selection there was no aligned system to facilitate the access of the important clinical information to verify the blood group compatibility between the donor and the recipient.

     At organ procurement, the Panel observed that there was no structured approach for compatibility checks by the Cardiothoracic Surgery Department (CTSD) Heart Procurement Team (HPT). It was noted that at Queen Elizabeth Hospital, the CTSD HPT verified the original copy of the donor's blood group results against the information on the fax copy received in Queen Mary Hospital.

     The Panel noted that at the recipient's admission, the hospital was not aware of the incompatible ABO blood groups of the donor and the recipient, although such had been documented. The Panel also observed that there was no purposely designed template to ensure blood group compatibility in heart transplantation.

     The Panel observed that when "Time Out" was conducted in operation rooms, the use of the general surgical safety checklist was inadequate in circumstances when there were specific requirements like compatibility of blood group of donor and recipient in organ transplant, transfusion safety alert, or the need for "must use" consumables. The Panel opined that if the safety checks had been in place at critical points of the workflows, the incident might have been stopped in time.

     Based on the observations and opinions, the Panel concluded that there were multiple contributing factors and conditions leading to the incident. These can be broadly summarised as:

1. Lack of information and communication support in heart transplant services to maintain a transplant patient registry and support recipient selection decisions;
2. Manpower constraints and unclear role delineation amongst heart transplant team members;
3. Lack of specialty training and succession planning to cater for increasing service demand; and
4. Unclear critical control points and documentation for verification of blood group compatibility between donor and recipient.

     The panel has made the following recommendations to improve the overall safety in transplant services:

1. Develop an information system for organ procurement and transplant to support clinical management and decision-making, and establish a governance structure to steer the development of an equitable organ procurement and transplant system to support and manage the organ transplant services in Hong Kong.

2. Review of heart transplant workflow to incorporate the verification of blood group compatibility between donor and recipient and ensure verification of clinical data including blood group compatibility at all critical control points of the transplantation processes. Workflows have to be streamlined and, leveraging on computerised systems, workflows automated to monitor and alert clinicians to errors and conflicting information. Checks at critical points should be incorporated and audited to ensure compliance.

3. Strengthen team structure for heart transplant service by well-defined roles and responsibilities for members, enhance training by protected structured training, build up capacity for heart transplant service by developing a succession plan of medical expertise to cater for the increasing demand in transplant services and explore the appointment of designated heart transplant co-ordinators.

4. Foster a team approach in enhancing patient safety through improving knowledge and skills in Crew Resources Management training to enhance safety culture in the heart transplant team.

     HKWC has accepted the investigation findings and recommendations while a number of improvement measures have already been implemented. HKWC had stepped up safety measures in heart transplantation within one week of the incident which include a review of the workflow to clarify the roles and responsibilities of each team member and strengthening the existing blood types compatibility verification mechanism. A mandatory dual verification for blood types was introduced. The compatibility of the blood groups will be verified by the transplant surgeon and a nurse at the graft harvesting stage and by the chief transplant surgeon and the second transplant surgeon immediately before the operation.

     An interim information system will be implemented in three to six months to automate blood group compatibility verification between donor and recipient for heart transplants. The HA is reviewing the situation and assessing feasibility in enhancing the Organ Registry and Transplant System (ORTS) to incorporate heart transplants. The ORTS is the online information system developed for storage of information for potential recipients of renal and liver transplants, apart from the Organ Procurement System and Transplantation and Immunogenetics Laboratory System.

     HKWC will review the team structures according to the Panel's recommendation. In addition, HKWC will enhance the training of team members. Crew Resources Management training is scheduled for the end of this year to enhance safety culture in the heart transplant team.

     HKWC also wishes to express appreciation to the Investigation Panel for its hard work in reviewing the incident and making valuable recommendations to improve the heart transplant services for the people of Hong Kong.

     While the Cluster fully acknowledges and appreciates the dedication of the clinical teams in the essential life-saving services, it would follow up on the case according to established human resources procedures.

Ends/Thursday, July 25, 2013
Issued at HKT 17:45

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