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The following is issued on behalf of the Hospital Authority:
The spokesperson for the New Territories West Cluster (NTWC) made the following announcement today (September 26) regarding the investigation of the Tuen Mun Hospital (TMH) alkaline phosphatase (ALP) reference range deviation incident:
TMH announced an ALP reference range deviation incident on July 22. The NTWC appointed a panel, with participation of independent member and pathology expert, to investigate the root cause of the incident and to make recommendations for improvement. The panel has completed the investigation and the report has been submitted to Hospital Authority Head Office and NTWC.
The panel has interviewed the staff concerned, examined the workflows and reviewed the relevant documents.
TMH Clinical Pathology Department procured a new Laboratory Automation System in March 2013. The system included major Chemistry and Immunoassay tests, which would provide many laboratory tests including the ALP test. The system installation was a major project involving the relocation of hematology services and renovation of the laboratory. There was a need for the department to launch the system on schedule so that the whole range of chemical pathology services could be maintained.
As part of the installation process of the system, a laboratory staff of the department collected reference data from manufacturer, academic journals and publications. The staff subsequently compiled those data into an excel file for cross checking by another two staff. In the excel file, the ALP reference ranges of male and female patients aged over 60 were accidentally swapped but this was not discovered in the cross-checking process. The data was eventually inputted into the system. This swapping of reference range was discovered on July 6, 2015 during the preparation of laboratory accreditation by the same staff who collected the data initially.
The spokesperson of NTWC said, "Having considered the information and reports reviewed, the panel acknowledged that there was an established workflow in the department to detect transcription error, but the error has escaped detection in this incident."
The panel made the following recommendations:
(1) Review the workflow ensuring independent entries of data fields by different members with subsequent reconciliation;
(2) Documentation of items cross-checked and different amended version is required;
(3) Steps of reconciliation between reference ranges of laboratory report and source documents should be adopted; and
(4) A standard operating procedure on cross-checking procedure should be better communicated to staff.
The panel also advised as a good practice in general to appoint multi-disciplinary project teams to monitor the installation and function test when major medical equipment system is being installed in future, taking into consideration manpower, workload and project timeline.
The spokesperson added, NTWC would implement the recommendations suggested to avoid similar incident happening again.
Among the 4,634 male patients involved, 1,425 passed away due to various reasons before the announcement of the incident. 2,973 did not require reassessment as the interpretation of their results were not affected by the ALP reference range deviation. 236 patients required calling back for reassessment.
Among the 236 male patients required call back, 185 of them had been examined and none of the patient was the treatment found to be adversely affected. 40 patients have at this time not decided whether to take examination or refused. 10 of them could not be contacted in this period of time or passed away due to various reasons after the announcement of the incident. One patient was followed up by private medical practitioner.
TMH has also conducted and completed review of the reports for the 2,973 male patients who did not require calling back. TMH is also reviewing the 1,425 reports of those male patients who have passed away due to various reasons previously.
Among the 4,809 female patients involved in the incident, TMH has reviewed their records and noted that no unnecessary invasive treatment such as liver biopsy was performed.
The spokesperson reiterated, "The incident only involves reference range being swapped. There is no error in the test results and TMH so far has not identified any patient's treatment being adversely affected by the incident."
NTWC will thoroughly study the report and if necessary follow up in accordance with prevailing human resources procedures of Hospital Authority.
NTWC expresses sincere apology to all patients concerned again and will continue to provide necessary support. NTWC also expresses appreciation to the chairman and members of the panel. Membership of the panel is as follows:
Chairman:
Dr Tang Kam-shing
Service Director (Quality & Safety), New Territories West Cluster
Members:
Dr Chan Ho-ming
Consultant (Chemical Pathology), Prince of Wales Hospital
Dr Lam Kit-yi
Chief Manager (Patient Safety & Risk Management), Hospital Authority Head Office
Mr Wong Wai-keung
Scientific Officer (Medical) (Clinical Biochemistry), Queen Mary Hospital
Ms Yan Hau-yee
Member, Tuen Mun Hospital Governing Committee
Ends/Saturday, September 26, 2015
Issued at HKT 16:30
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