Monday, April 11, 2011

SERRATIA MARCESCENS, CONTAMINATED SOLUTION - USA (02): (ALABAMA)

**************************************************************** A ProMED-mail post ProMED-mail is a program of the International Society for Infectious Diseases [1] Date: Thu 7 Apr 2011 Source: Fox 6 News, WBRC [edited] Bacteria that affected 19 Alabama hospital patients and possibly led to the death of 9, initiated on a faucet [tap] at the Homewood-based Meds IV pharmacy, according to the Alabama Department of Public Health. Samples of the bacteria, _Serratia marcescens_, were identified on a sink faucet in the pharmacy. Water from that tap was used along with soap to clean out a container used to create an amino-acid compound used to create TPN [total parenteral nutrition], the intravenous food supply given to the affected patients. The bacterium was also found on an impeller, a large stirring instrument used to mix up the amino-acid compound. Finding _Serratia_ bacterium on a faucet is not uncommon, according to State Health Officer Dr Don Williams. What's troubling, he said, is that the filter used to sterilize the product failed and this is where the real problem lies. Williams said in a press conference Thursday [7 Apr 2011] it was his department's 1st experience dealing with an outbreak of this kind and is working with the FDA to determine if washing containers with unsterile water is within federal guidelines. Williams confirmed that there is no risk to any other patients going forward and the problem is absolutely limited to the TPN obtained by Meds IV. He said the Centers for Disease Control and Prevention [CDC] polled other states to see if anyone else was seeing similar problems with the bacteria and TPN. The CDC found the problem was limited to Alabama, and only to the patients who received TPN from Meds IV. "There is nothing to suggest that any of the infections were associated with any pharmacy other than Meds IV," Williams said. "Based on everything that we know, it is clearly linked to the compounding of TPN in that pharmacy." The ADPH has identified the weak point in the chain of infection, but is still investigating what went wrong with the sterilization process. Last Friday afternoon [31 Mar 2011], a Fox 6 News crew saw several federal agents moving boxes out of the Meds IV pharmacy on West Oxmoor Road. A Shelby County judge granted a temporary restraining order preventing Meds IV from destroying any evidence which could be used in a lawsuit. Shelby Baptist Medical Center, one hospital where an infected patient died after using TPN sold by the pharmacy, sued Meds IV. Judge Hewitt Conwill will hear a motion Friday [8 Apr 2011] from Meds IV employees who wish to lift the restraining order so they may retrieve other materials from the location. [Byline: Tiffany Glick] -- Communicated by: ProMED-mail ****** [2] Date: Fri 8 Apr 2011 Source: The Birmingham News [edited] A failure in the sterilization process at a Birmingham pharmacy appears to have caused the infection that sickened 19 people in Alabama hospitals, 9 of whom died, the state health department said Thursday [7 Apr 2011]. Investigators found exact matches of the bacteria on a water faucet [tap], a container, and a device used to mix intravenous nutritious supplements at Meds IV, state health officer Don Williamson said. But there are still questions about how the contamination occurred. "We've identified the weak point in the chain where infection occurred," Williamson said. "We're now trying to figure out exactly what happened." The Alabama Department of Public Health and the federal Centers for Disease Control and Prevention have been investigating the outbreak of _Serratia marcescens_ in 5 hospitals around Birmingham and one in Prattville. It is linked to bags of TPN, total parenteral nutrition -- a supplement given intravenously to patients too sick to eat -- mixed by Meds IV and sent to those hospitals in January, February, and March [2011]. Williamson said Thursday [7 Apr 2011] that samples of the bacteria were taken from Meds IV's compounding room, grown out and run through a genetic fingerprinting process. The same strain found in the TPN and in 12 patients turned up on the water tap and mixing equipment. Samples weren't available from 6 patients and one is still in process, the health department said. _S. marcescens_ also grew from samples taken from a bag of amino-acids used to make the TPN, but that culture hasn't been fingerprinted yet; investigators suspect it will match and was tainted at the pharmacy. Williamson said Meds IV staff used tap water to wash the mixing vessel before rinsing it with sterile water. Then the amino acid solution, which was mixed from a powder and sterile water, was also contaminated by touching the equipment. That amino-acid mixture is supposed to be run through a filter small enough to catch the bacteria, Williamson said. But for some reason, that didn't work. "The thing that's really troubling is that the 0.2 micron filter that's used to sterilize the product failed to do that," he said. At this point, he said, it's not clear what went wrong, and whether the problem lies in the process itself, a flaw in the filtering equipment or in human error. Williamson said health investigators are working with the Alabama Board of Pharmacy and federal Food and Drug Administration (FDA) to find out more about what went wrong. Jim Ward, a lawyer representing the pharmacy board, said the board's head inspector is trying to interview everyone who worked in the pharmacy to get a picture of what happened. In addition, they're waiting to review records that were seized by the FDA. "Obviously, we weren't there when the sterilization and the mixture process was going on," Ward said. "Until we have a chance to talk to everybody and find out what's going on, we aren't going to know everything that people want us to know." Williamson said investigators plan to look at patients who received TPN in those 6 hospitals but did not show signs of infection and is working with the FDA to get samples of other recalled products made by Meds IV. For now, he said, they're not aware of any additional contamination. "As we go forward, there are several things we still have to investigate," Williamson said, adding that it could take weeks to get more answers. "We are not done." [Byline: Hannah Wolfson] -- Communicated by: ProMED-mail [A total of 19 people in 6 Alabama hospitals developed _Serratia marcescens_ bacteremia after receiving TPN (total parenteral nutrition) produced by a single pharmacy; 9 of the patients died. The _S. marcescens_ isolated from 12 of the 19 individuals have the same genetic fingerprint as the organisms isolated from a container and stirrer used to mix the powdered amino-acids, from the tap water faucet used for rinsing the container, and from the TPN. Genetic fingerprint results are pending for a bag of compounded amino-acids used in the production of TPN that has also grown _S. marcescens_. _S. marcescens_ is a common environmental contaminant. This investigation illustrates the ability of DNA genotyping to confirm the epidemiologic linkages in the attempt to identify the source of this outbreak. Preparation of TPN is complex, requires use of sterile techniques to avoid microbial contamination, and well-trained personnel. We await results of further investigations to find the cause of the problem. The state of Alabama can be located on the Gulf coast of the USA on the HealthMap/ ProMED-mail interactive map at . - Mod.ML] [Symptoms of _S. marcescens_ infection include urinary and respiratory tract infections, endocarditis, osteomyelitis, septicemia, wound infections, eye infections, meningitis, treatable with cephalosporins, gentamicin, amikacin. But most strains are resistant to several antibiotics because of the presence of R-factors on plasmids. Picture of a lab culture of _S. marcescens_ (natural red pigment) at - Mod.JW] [see also: Serratia marcescens, contaminated solution - USA: (AL), alert 20110330.0987 2008 ---- Serratia marcescens, pre-filled syringes - USA: recall 20080122.0267 Undiagnosed reactions, fatal, heparin - USA: (FL), alert, recall 20080119.0242 2007 ---- Serratia marcescens, heparin syringe - USA (02): (FL) 20071222.4112 Serratia marcescens, heparin syringe - USA: (IL, TX), alert 20071220.4090 Serratia marcescens, hospital, neonatal - Honduras (S. Pedro Sula) 20070316.0931 2005 ---- Serratia marcescens, contaminated solution - USA (NJ): alert 20050320.0808] .................................................ml/mj/jw *##########################################################* ************************************************************ ProMED-mail makes every effort to verify the reports that are posted, but the accuracy and completeness of the information, and of any statements or opinions based thereon, are not guaranteed. The reader assumes all risks in using information posted or archived by ProMED-mail. ISID and its associated service providers shall not be held responsible for errors or omissions or held liable for any damages incurred as a result of use or reliance upon posted or archived material. ************************************************************ Donate to ProMED-mail. Details available at: ************************************************************ Visit ProMED-mail's web site at . 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