Blood alert 'delay' criticised

CSL Biotherapies is under fire from health authorities for taking six weeks to alert regulators that anti-freeze had leaked into a tank used for the human blood product albumin.

By InvestSMART · 10 Mar 2012

By InvestSMART ·
10 Mar 2012

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CSL Biotherapies is under fire from health authorities for taking six weeks to alert regulators that anti-freeze had leaked into a tank used for the human blood product albumin.

BLOOD products company CSL Biotherapies is under fire from health authorities for taking six weeks to alert regulators that anti-freeze had leaked into a tank used for the human blood product albumin.

The company's disclosure to authorities this week triggered a nationwide recall from hospitals of all stocks of albumin, a plasma protein administered to serious burns and trauma patients.

CSL discovered small amounts of the ethylene glycol in an albumin tank on January 25. The chemical, used to control temperature, had leaked through a hairline crack in the casing around the tank.

Initial tests found no contamination and it was only on Wednesday this week after more testing that the company alerted the Therapeutic Goods Administration that it had identified contaminated albumin.

A spokeswoman for CSL said the later testing ''unexpectedly'' found batches produced before an inspection on December 14, showed presence of contaminant, albeit at low levels. The company said it made a ''quick and thorough response''.

But Australia's chief medical officer, Dr Chris Baggoley, told The Saturday Age yesterday that the Therapeutic Goods Administration would be pressing CSL for answers as to why it took until this week for the company to inform it. ''That is a question the TGA will be putting to CSL, as to why, when they found the problem related to manufacturing in late January, even if they thought they had it contained, why did they not advise the TGA at the time.''

Dr Baggoley said the company only alerted the TGA this week after further checking of samples from last year revealed traces of the ethylene glycol.

Because CSL was still trying to find out when the contamination started ''we have to assume that all albumin in hospitals could potentially be contaminated'', Dr Baggoley said.

Public hospital spokeswoman Prue Power has called for a full inquiry.

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Frequently Asked Questions about this Article…

What exactly happened at CSL Biotherapies that led to a recall?

CSL discovered small amounts of ethylene glycol (an anti‑freeze chemical) in an albumin tank on January 25. After further testing this week found traces of the contaminant in some batches, the company alerted the Therapeutic Goods Administration (TGA) and triggered a nationwide recall of all hospital stocks of albumin.

Which product is affected by the contamination and who uses it?

The affected product is albumin, a plasma protein administered to patients with serious burns and trauma. Hospitals use albumin in critical care situations.

How did ethylene glycol get into the albumin tank?

CSL said the ethylene glycol — used to control temperature — leaked through a hairline crack in the casing around the albumin tank.

When did CSL find the leak and why did it take time to notify regulators?

CSL identified ethylene glycol in the tank on January 25. Initial tests reportedly found no contamination; only after additional testing this week did the company identify contaminated batches and notify the TGA. Australia’s chief medical officer said the TGA will ask CSL why it did not advise regulators earlier.

Which regulator is involved and what has been said about the scope of the problem?

The Therapeutic Goods Administration (TGA) was notified. Because CSL is still trying to determine when contamination began, the TGA said we must assume all albumin in hospitals could potentially be contaminated until the investigation clarifies the extent.

How did CSL describe the contamination levels and its response?

A CSL spokeswoman said later testing 'unexpectedly' found contaminant at low levels in batches produced before a December 14 inspection. The company said it made a 'quick and thorough response' once the contamination was identified.

What immediate actions were taken by hospitals and health authorities?

The disclosure prompted a nationwide recall from hospitals of all albumin stocks. Health authorities are pressing CSL for answers and public hospital representatives have called for a full inquiry.

What should investors know about the regulatory scrutiny around CSL Biotherapies?

Investors should be aware that CSL is facing criticism for the delay in informing regulators about an ethylene glycol leak into an albumin tank. The TGA is seeking answers about the timeline, a nationwide recall has been issued, and public calls for a full inquiry have been made — all facts reported by health authorities and CSL in the article.