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The following is issued on behalf of the Hospital Authority:
A number of recommendations were proposed by an investigation panel to further enhance the standards and safety of blood donation, storage and transportation processes as well as the clinical management of blood transfusion reactions. The four-member panel, headed by Professor Yuen Kwok-yung, Head of the Department of Microbiology at the University of Hong Kong, was appointed by the Hospital Authority (HA) earlier this month to investigate a rare transfusion reaction event at Tuen Mun Hospital.
The Director (Quality & Safety) of the HA, Dr Leung Pak-yin, said today (January 22) that the authority had already received the investigation panel's report. Dr Leung thanked the panel members for their professionalism and efficiency in completing the investigation on such a tight schedule. The authority accepts the recommendations and would examine them in detail for implementation in order to enhance the standards of patient care and services, he said.
In accordance with normal practice, arrangements were made by Tuen Mun Hospital (TMH) to meet with the family of the deceased patient this afternoon at 2.30 pm to explain the investigation findings as well as the hospital's follow up measures. Following that, a press conference was held at 3.30pm for the chairman of the panel, Professor Yuen Kwok-yung, to announce the investigation findings and recommendations to the public.
Led by Professor Yuen, the investigation panel members included Dr Raymond Chu, a member of the Hospital Authority (Blood Transfusion Service) Expert Panel on Blood and Blood Products Safety; Dr Yeung Yiu-ming, Consultant Haematologist of Tuen Mun Hospital; and Dr Tsoi Wai-chiu, Associate Consultant of the Blood Transfusion Service. The panel has investigated thoroughly the events starting from donation to transfusion of the contaminated blood unit to the patient, as well as the subsequent clinical management.
In announcing the findings and recommendations of the report today, Professor Yuen noted that the standards of transfusion service in Hong Kong and clinical management at TMH were observed to be very good. The rare transfusion reaction event in TMH was indeed a sporadic case.
"All professionals involved in this investigation have followed the international standard and guidelines in their service. No individuals should be held responsible for the occurrence of such a rare incident," said Professor Yuen.
"Despite the efforts of the panel, it is not possible to find out exactly what had happened about a month ago. Nevertheless, the panel has successfully tested that the DNA fingerprints of the bacteria, Pseudomonas fluorescens, isolated from the blood culture of the patient concerned, the transfused red cell unit and only one of the many condensate specimens in a foam box container with coolants used for transporting blood units, were found to be identical. However, it is not possible to prove retrospectively the sequence of events leading to the contamination."
For risk reduction purposes, the panel made recommendations based on risk analysis at critical control points of the processes including communication, the findings on retrospective microbiological testing and the information in existing literature. Highlights of the recommendations are as follows:
On Blood Donation, Storage and Transportation
- Phlebotomists and nurses performing blood collection must ensure that the stipulated skin disinfection timing is registered by the use of a timing device such as a timer or stop clock.
- Ensure all blood bag tubings are dry and free of visible surface condensation prior to thermal sealing and milking by strippers. These procedures should be minimised.
- Measures must be taken to minimise the amount of condensate in the blood unit transport container or any storage sites. These containers must be regularly disinfected to reduce the environmental bacterial density so as to minimise the risk of contamination through inconspicuous pin hole defects in blood bag tubings.
On Blood Transfusion and Management of Reactions
- An auditing programme for transfusion reactions and their management according to HA guidelines should be considered.
- Unexplained cause of shock and fever should be treated by one dose of broad spectrum antibiotics with anti-pseudomonas coverage after taking blood culture from the patient. It is also important not to abuse antibiotics by giving them to every patient who developed fever after transfusion since most of them do not have a transfusion-related infection unless there are other clinical indications.
In response to the findings and recommendations of the report, the Blood Transfusion Service (BTS) expressed its gratitude to the panel led by Professor Yuen and accepted all the recommendations made in the report. The BTS also pledged to implement all necessary measures to minimise risk of any future recurrence of a similar incident.
As explained by Professor Yuen, the panel concluded that this incident was very rare and sporadic. Prior to this incident, 3,429,000 units of blood products had been issued during the past 10 years in Hong Kong and there had been no previous documented instance of red cell transfusion related bacterial infection or death. In the current case under review, all the blood units delivered in the same consignment as the contaminated units had been transfused to other patients prior to the incident and there have been no reports of any untoward reaction.
The Senior Medical Officer of the BTS, Dr Lee Cheuk-kwong, states that the BTS has been strictly following well established international standards in its operations, and applies regular ISO and c-GMP audits, both internal and by accredited external bodies, to ensure full system integrity. Although the incident was rare and the route of contamination was not proved in this investigation, for risk reduction purposes, the BTS has implemented the following measures:
1. Temporarily suspend the use of all mobile blood collection vehicles and discuss the feasibility of the recommended design improvements with the vehicle manufacturers
2. Work with the manufacturer to ensure the continuing quality of blood bags
3. Provide timers at blood collection venues to ensure the donor skin disinfection duration complies strictly with the BTS' stipulated standards
4. Ensure all blood bag tubings are dry and free of visible surface condensation prior to thermal sealing and milking by strippers, and minimise manipulation of blood bags and tubing, except for the mandatory steps in processing and production i.e. blood collection, component preparation, labelling and issue
5. Re-design packaging of blood units to minimise their exposure to condensate formed in foam boxes during transportation to hospitals.
6. Implement additional stringent cleaning and disinfection procedures for all equipment used in blood collection, processing and storage (including the blood transportation foam boxes and refrigerators) and reinforce training of frontline staff on these new procedures
7. Implement a surveillance system by using discarded blood units for bacterial culture and monitor the outcomes
"These measures will be shared with transfusion services in other countries and the BTS will continue to implement other countries' good practices as they arise. The BTS will continue practising the established stringent disinfection procedure for blood donation including the use of alcohol hand-rub by staff each time before serving blood donors." Dr Lee emphasised that blood donation remains a very safe process and appeals for more people to donate blood to build up the BTS inventories for the coming Chinese New Year long holidays.
"The BTS would like to apologise to the public for the concerns caused by this incident and joins the Hospital Authority and Tuen Mun Hospital in expressing the deepest condolences to the family of the deceased patient."
Tuen Mun Hospital also accepts the recommendations made in the panel's report. Accordingly, TMH has implemented the following strengthening measures and revised the related protocol and guidelines immediately:
1. Revise the existing antibiotics prescription protocol - Under the revised protocol, patients who develop unexplained shock and fever should be treated with one dose of broad spectrum antibiotics after taking blood culture, taking into consideration the clinical indications
2. Revise the existing blood test protocol - All the blood bags received by the blood bank from clinical units after transfusion should be attended to around the clock. A series of investigations would be processed immediately, including blood culture and gram stain test. The doctor initiating the investigations should be informed of the result once available
3. Strengthen the sterilisation and disinfection measures of the blood bank and all related containers
The spokesman for TMH said, "The panel opined that the hospital staff had been complying with the guidelines and protocol and the practice was up to international standard. Moreover, the hospital has taken the opportunity to implement further improvement measures. We agree that this rare and serious event has enabled us to review the current guidelines and protocol. The hospital has strengthened and fostered staff's alertness and compliance on the stringent transfusion protocol when carrying out transfusion procedures for patients."
TMH has all along been closely communicating with the family of the deceased patient. The hospital explained the investigation result and findings to the family today as well as the hospital's follow up arrangements. The hospital reiterated that close contact would be maintained with the family to provide all necessary support. Together with the Hospital Authority, TMH expresses once again its deepest condolences to the family of the deceased.
The summary and recommendations of the report have been posted on the HA homepage, www.ha.org.hk/report/tmh080122report.
Ends/Tuesday, January 22, 2008
Issued at HKT 19:37
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