Replies to Media Queries on Hepatitis C Cluster in Singapore General Hospital

MOH has received many media queries today on the cluster of 22 cases of acute Hepatitis C in SGH.  Three issues stand out among the queries and MOH would like to respond to these.  Please find our reply below attributable to the MOH spokesperson.

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Do our hospitals use multi-dose vials in their daily operations?
What are the guidelines for doctors and nurses using these vials?
Have you ever had transmissions of infectious diseases as a result of use of multi-dose vials? What could go wrong to cause this to happen?

Both single-dose and multi-dose injection medication vials are used in our public hospitals. Our public hospitals utilise multi-dose vials where the preparation is specifically formulated for such use, and governed by safety protocols.

The investigations into the cluster of Hepatitis C virus infections at SGH are still ongoing, and it is not yet conclusive that the use of multi-dose vials is the cause of the Hepatitis C infection in this incident.

Regardless of whether medication vials are single-dose or multi-dose, their safe use requires healthcare providers to adhere to existing safety protocols for the use of medication vials. Staff education, appropriate training and compliance to the protocols are important in ensuring patient safety. The WHO stresses the importance of implementing injection-related infection prevention and control, safe practices that are associated with medical procedures, including needle injections, intravenous infusions, injection devices and medications, etc., which are to ensure safe use of injections in healthcare settings. The measures include hand hygiene, appropriate use of gloves and personal protective equipment, skin preparation and disinfection, as well as other specific measures related to the preparation and administration of injections. 

As multi-dose vials are potentially at risk of contamination between uses, their safe use requires additional safety and infection prevention and control measures that staff have to comply with, such as opening only one vial of a particular medication at a time in each patient-care area, as recommended by WHO. Failure to comply to safety protocols may cause infection.

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Do public hospitals have to report cases of Hepatitis C to MOH?
If so, why did MOH not know about the Hepatitis C cluster in SGH earlier?

Under the Infectious Diseases Act, cases of acute viral Hepatitis C must be notified to MOH within 72 hours. Chronic cases need not be reported.

Most acute infections of viral Hepatitis C are silent i.e. without symptoms. As it can be difficult to detect such asymptomatic Hepatitis C based on blood tests alone, doctors generally look for a link to an event of relevant exposure, such as current intravenous drug use or a needle-stick injury. So, cases notified to MOH by clinicians have mostly been acute cases with symptoms such as jaundice.

MOH also receives notifications from laboratories based on test results (which can be from acute or chronic infections), and such notifications are reviewed to classify them. MOH received notifications of the cases from SGH’s Laboratory. However, at the point of reporting, the cases did not have symptoms such as jaundice nor history of exposure to suggest that they were acute. The cases were hence not reported in MOH’s Weekly Infectious Diseases Bulletin. After a subsequent review of the cases from SGH based on the information we now have, these can be classified as acute Hepatitis C. The number of reported cases in MOH’s Weekly Infectious Diseases Bulletin will be updated in the next report.

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What actions did MOH and SGH take after SGH informed MOH of the cluster in late August?

In late August 2015, SGH reported its identification of a cluster of 21 Hepatitis C cases and the outcomes of its investigations.  

On 3 September, after reviewing SGH’s report, Associate Prof Benjamin Ong, the Director of Medical Services (DMS) met with SGH clinicians to seek further clarifications. 

SGH informed DMS that the cluster of 21 patients had tested positive for the same hepatitis C genotype 1B. Preliminary phylogenetic studies* by SGH showed the Hepatitis C virus in the 21 patients were related. SGH also informed DMS that they had taken enhanced infection control measures and noted that there were no further cases after 24 June. (* Phylogenetic analysis is a specialised genetic test to identify the different sub-types of hepatitis C virus.)

At that meeting, DMS emphasised that SGH needed to conclusively verify where the gaps leading to these infections were and that an external review would be required.

Specifically, DMS requested for:

a)     External representation on two committees which SGH was setting up: the Medical Review Committee (MRC) to review clinical matters and the Quality Assurance Review Committee (QARC) to review infection control and patient safety processes;

b)    External verification of SGH’s phylogenetic analysis by an A*STAR laboratory as this was the first time the SGH had conducted such an analysis;

c)     SGH to prepare a mitigation plan with specific attention to screening of healthcare staff’s hepatitis C status; and

d)    A team from MOH to visit the affected ward to perform a process walk-through with SGH’s staff.

DMS asked that the work be done expeditiously, and no later than two weeks.

MOH nominated Prof Teo Eng Kiong, Chairman of Medical Board of Changi General Hospital and a specialist in gastroenterology and liver disease specialist to chair the MRC, and Dr Serena Koh, Deputy Director, Clinical Quality, Performance and Technology Division, MOH, and a trained nurse and midwife with expertise in patient safety to be a member of QARC.

On 4 September, an MOH team led by Dr Daphne Khoo, Group Director, Healthcare Performance Group, MOH, visited the renal ward (Ward 64A and 67) for a process walk through with SGH.

On 7 September, external verification of SGH’s phylogenetic analysis by an A*STAR laboratory was completed and confirmed SGH’s initial findings that the 21 cases were related.

On 9 September, SGH commenced Hepatitis C screening for all doctors and nurses involved in the direct care of the affected patients.  As of 25 September, 76 staff members have been screened.  All were found to be negative for Hepatitis C.

Both the MRC and QARC reviewed documents and notes, and also met with staff from SGH MRC had its meeting on 9 September while the QARC held its meeting on 23 September.  Among the work of the MRC was its review of whether the 7 deaths known up to that point were due to, or linked to, or had no links to the patient’s Hepatitis C condition.  [The 8^th death occurred on 30 September.]

On 18 September, having assessed that the additional investigations requested had largely been completed, DMS reported the identification of the cluster to the Minister for Health.  Minister Gan Kim Yong asked for a briefing from SGH.  SGH requested for the briefing to take place on 25 September to allow them sufficient time for the two committees to complete their investigation and submit their report to MOH. 

MOH was notified of the 22^nd case on 21 September.

SGH’s report was submitted to MOH on 24 September and a briefing to the Minister conducted on 25 September.  Minister Gan instructed that an independent review committee be set up, and for SGH to make public its preliminary findings.  MOH and SGH made preparations to appoint the independent review committee and prepare for a media briefing.  (Note: Patients who contracted Hepatitis C were informed about their condition and treatment options individually by their attending doctors.)

On 28 September, DMS appointed members of the Review Committee, which comprise respected clinicians from different disciplines (Hepatology, Renal medicine, Infection Control, Nursing, and Quality Improvement and Process Audit), all of whom do not have affiliation with SGH.  Dr Jeffery Cutter, Director, Communicable Diseases Division, MOH is a representative on the committee.

On 6 October, SGH conducted its media briefing.  MOH released a press statement on the appointment of the independent MOH Review Committee.

In the investigation, the primary consideration has been to try to get to the root cause of the issue as soon as possible, exploring all possible angles, to prevent recurrence.  At the same time, the teams from SGH and MOH were mindful of the need to make public the cases as soon as preliminary investigations were completed.

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MINISTRY OF HEALTH
7 OCTOBER 2015