|
An investigation was initiated in response to a customer complaint of experiencing an increase in the number of contaminations observed after inoculation in association with the bact/alert® fa plus (plastic) (ref (b)(4).---investigation--- review of customer communications: the information provided by the customer has been summarized below: ¿ customer provided a list of accession numbers, bottle type drawn, organism identification, drawn location, date drawn, age of the patient ¿ bottles are inspected for damage prior to use ¿ bottle top is cleaned after removing the flip cap with an alcohol wipe from the biomérieux worksafe kit and allowed to dry for 1 minute ¿ all bottles were drawn by venipuncture after cleaning with chlorhexidine which was allowed to dry for 3-5 minutes ¿ butterfly (direct draw) was used for venipuncture draws ¿ blood cultures were drawn first ¿ age of patients ranged from 30 to 85 years old ¿ nurses and phlebotomists performed the blood draws ¿ the majority of the bottles were drawn in the emergency department (ed) by nurses ¿ no delay in loading bottles into the bact/alert virtuo instrument ¿ diagnostic logs (dlogs) from virtuo for the date range of 18feb2022-01mar2022 were provided by the customer ¿ backup, bottle identifications, and time to detection (ttd) for the contaminated bottles were also provided by the customer ¿ temperature readings were between 36.9-37.1 showing no fluctuation ¿ no power events occurred ¿ six lot numbers were found in the dlogs for different bottle types: fa plus, fn plus, and pf plus ¿ in all, there were 25 bottles that were contaminated: 9 fa plus bottles, 11 fn plus bottles, and 5 pf plus bottles ¿ 14 out of 25 bottles were collected in the emergency department (ed) and 12 out of the 14 bottles were drawn by the nursing staff global customer service (gcs) met with the local customer service manager, field application specialist, and the microbiology account manager to discuss customer's complaint issue on 10mar2022 and 16mar2022: ¿ the microbiology account manager indicated that the customer agreed to let biomérieux provide blood collection training to the nursing staff ¿ the customer followed up with other vendors for products also used in the blood culture collection ¿ the contaminants were different species and mostly coagulase negative staphylococci (skin flora) complaint trend analysis: global customer service (gcs) completed a complaint trend analysis and did not identify the customer's issue as a trend for the bact/alert fa plus.There is no adverse trend for the error code bottle contam inoculated-skin flora - b256.Manufacturing processes for bact/alert products and bioburden: monitoring and detection methods are inherent to manufacturing processes to identify any potential contamination of the culture bottles as a result of the bact/alert culture bottle production.One of the monitoring and methods takes place with the unique device identifier (udi) packaging line with 100% inspection of bottles.Another monitoring and detection method is performed during the packaging acceptance quality limit (aql) and final aql visual inspections.A sampling of bottles is inspected as per an aql which is a maximum number of defective units that can be considered acceptable as a process average.If over the limit, the stack/rack/pallet is segregated, and a deviation is initiated to investigate the defect issue.There are two (2) categorized bottle defects that are associated with potential bottle contamination during the manufacturing of the bact/alert culture bottles.(1) sensor color: manufacturing defect: a sensor color that has changed from blue/gray/green color to a yellowish hue across the bottom surface of the bottle generally due to contamination.All bottles are 100% inspected via an automated inspection at packaging.(2) turbidity: manufacturing defect: media turbidity may be due to the presence of microbial growth/contamination.The media will appear cloudy, and the sensor may or may not be discolored.Another aspect of monitoring and detection of possible bottle contamination is through the routine qc release testing for bioburden.This testing is conducted on a sampling of bottles taken prior to terminal sterilization by autoclaving.Bioburden determines the number of microbial organisms found in a given amount of material associated with contamination introduced from possible sources as raw materials, personnel, equipment or cleanliness of the production environment.The bioburden testing of bact/alert production lots aids in the monitoring of any adverse fluctuation that can potentially occur between lots.The customer did not convey any specific lot numbers; however, dlogs from the customer¿s virtuo instrument and a shipping history report revealed that the fa plus, fn plus and pf plus bottle types were sent to the customer (refer to attachment 3-lot numbers).The customer did not report any bottle defects prior to use.Inoculation of samples into the bact/alert plus bottles by the user contributed to this complaint issue.Therefore, batch reviews and associated deviation/capa trend queries were not required for this investigation.Root cause of the complaint investigation: the fishbone diagram (¿5m+e¿) method of analysis was used to investigate and identify the potential root cause/root cause for this complaint.This cause and effect analysis identifies aspects of the issue in relation to following conditions: measurement, materials, method, machine, manpower, and environment.An analysis was conducted on the durham manufacturing site and the communication between customer service and the customer pertaining to the troubleshooting events that occurred for this complaint.The problem statement was the customer reported inoculated contamination with bact/alert fa plus, fn plus, and pf plus culture bottles.The is-is not matrix was used to narrow down the factors and verify which ones potentially contribute/contribute to this complaint and those that do not have impact or contribute to this complaint investigation.Is-is not is identified after each of the following sections.Manpower and environment are the potential contributing factors to the root cause of this complaint.---conclusion--- there is no evidence of any bottle malfunction with the bact/alert fa plus, fn plus, or pf plus culture bottle lots.The bact/alert fa plus, fn plus and pf plus bottles did detect organism growth as intended; however, the majority of the organisms detected were coagulase-negative staphylococci flora, suspected contaminants as per the customer.Monitoring and detection methods for potential bottle contamination are part of the manufacturing and quality control processes for bact/alert culture bottles prior to the release of product to customers.The investigator reviewed the instructions for use [ifu] and determined they provide adequate direction to prevent specimen contamination during collection/inoculation into the bact/alert bottles: ¿ proper skin disinfection is an essential requirement to reduce the incidence of contamination.¿ prior to inoculation, disinfect the culture bottle top with an alcohol swab or equivalent.Allow to dry.¿ prevent contamination of the patient sample during venipuncture and during inoculation into the culture bottles.Contamination could lead to a specimen being determined positive when a clinically relevant isolate is not actually present.¿ culture bottle contamination may not be readily apparent.Monitor the direct draw process closely to avoid reflux.¿ refer to cumitech 1c blood cultures iv, asm press, 2005: ¿ collection of blood cultures: skin antisepsis: (1) ¿failure to adequately cleanse the skin using meticulous technique and an appropriate antiseptic agent increases the risk that microbial flora of the skin¿will contaminate the blood culture.¿ (2) ¿the available data suggest that iodine tincture and chlorhexidine products are likely to be equivalent and that both may reduce contamination rates to a greater degree than products containing povidone-iodine preparations.¿ (3) ¿the venipuncture site should be prepared by first vigorously cleansing for 30 s (seconds) back and forth across the site with 70% isopropyl alcohol followed by either 1 to 2% tincture of iodine, which is allowed to dry for at least 30 s (seconds) or 2% chlorhexidine, which is allowed to dry for at least 30 s (seconds) before inserting the needle.¿ ¿ collection of blood cultures: methods for obtaining blood for culture: (1) ¿venipuncture remains the technique of choice for obtaining blood culture.¿ (2) ¿blood cultures obtained from indwelling intravascular access devices are associated with greater contamination rates than are blood cultures obtained by venipuncture.¿ ¿ false-positive blood cultures (¿contaminants¿): (1) ¿differentiating ¿contaminants¿ from true pathogens is extremely difficult, especially because the same species can easily be found in either situation.¿ (2)¿ ¿the organisms commonly associated with contaminated blood cultures (bacillus [not b.Anthracis] spp., coagulase-negative staphylococci, viridans group streptococci, aerococcus spp., micrococcus spp., and many others) ¿¿ (3)"¿avoidance is the best policy, and this can be accomplished most effectively by paying strict attention to the process of skin antisepsis, venipuncture, and specimen transfer to blood culture bottles¿¿ ¿ avoid laying bottles down in patient¿s bedding as it may lead to a potential route of contamination ¿ cell phones could harbor microorganisms (e.G., skin flora) that could contribute to the contamination of blood drawing devices (e.G., blood culture bottles).Proper hand washing and disinfection of cell phones would potentially reduce sources of culture bottle contamination.
|
