Red Fl. Raising the Susan Dolan, RN, MS, CIC, hospital epidemiologist for

Transcription

1 Red Fl Raising the Susan Dolan, RN, MS, CIC, hospital epidemiologist for Children s Hospital Colorado (Children s Colorado) and chair of the APIC Public Policy Committee, knew something was amiss when two patients at the hospital developed severe, invasive Bacillus cereus (B. cereus) infections after admission in late October/early November of The first patient developed clinical sepsis and extensive cellulitis 24 hours after the placement of a vascular access device. The second patient, who had congenital heart disease, was admitted to the Emergency Department (ED) for respiratory distress due to a confirmed respiratory virus; on day four of the hospitalization, the infant became clinically septic. Both patients blood cultures grew B. cereus. We all looked at one another and said, This is really unusual, Dolan said of the staff s reaction when they heard about the infant s case of sepsis during daily clinical microbiology rounds. This set off the red flag in our minds. These two unusual cases prompted an outbreak investigation that began on November 15, She and a multidisciplinary team of microbiologists, infection preventionists, epidemiologists and physicians went to work in an effort to identify the cause of this elusive infection, which is commonly found in the gut and is well known as a common cause of foodborne illness. They needed answers, and they needed them fast, to protect their vulnerable, young patients. Little did Dolan know that she and her team were about to prompt one of the most extensive international recalls with an impact that would reverberate around the world. 44 AUTUMN 2011 Prevention

2 findings of an APIC member s outbreak investigation prompted an extensive international product recall, preventing patient harm across the globe. agthe BY JANIENE TORCH APIC ASSOCIATE DIRECTOR OF COMMUNICATIONS PHOTOS BY STEVE KAST AND TIA BRAYMAN CHILDREN S COLORADO PHOTOGRAPHY DEPARTMENT James K. Todd, MD; Ann-Christine Nyquist, MD; Cindy Littlehorn, MT SM(ASCP); Elaine Dowell, MT, SM(ASCP); Mary P. Mimi Glodé, MD; and Susan A. Dolan, RN, MS, CIC, played a critical role in the recall of contaminated alcohol prep pads in early Prevention AUTUMN

3 Dolan and her team heard about the second confi rmed case of Bacillus cereus during daily clinical microbiology rounds. This set off the red fl ag in our minds, said Dolan. Dolan interviewed staff in the operating room and staff who had performed the blood cultures in the ED to see if they noticed anything unusual when dealing with the patients. She said they did not note anything out of the ordinary. Because Children s Colorado saves all of its patients blood isolates, the team was able to compare the isolates of the two infected patients, to determine if they carried the same strain of B. cereus. During the systematic process of conducting an outbreak investigation, the team explored products, procedures and surgical equipment to determine the source of B. cereus. After completing a chart review and interviewing staff, Dolan identified three products for laboratory testing that seemed common in most of the B. cereus cases she had investigated. Dolan brought the lab three terminally sterilized syringes prefilled with sterile saline solution; three 2 percent chlorhexidine gluconate (CHG)/70 percent alcohol solution applicators used for skin preparation; and four individually packaged 70 percent isopropanol alcohol prep pads (APPs), which were not labeled as either sterile or non-sterile. These APPs, manufactured by Triad Group, were labeled as an antiseptic for external use only and were meant for the preparation of skin prior to injection, which is the same indication as sterile APPs. What is interesting to me is that I always thought of these products as completely sterile, said Dolan. What I learned is that if a package doesn t clearly say sterile, the product may not be sterile and/or only some components Want to hear Susan Dolan speak first-hand about the recall experience? To hear Dolan s session from APIC 2011, order the Premium Conference Proceedings. Gain access to all of the educational sessions and presentation slides, as well as all poster presentations from APIC Upgrade to the Premium Conference Proceedings to access all videos from the conference, including the opening keynote address. You can play the Premium Conference Proceedings on your computer, or you can transfer them to a portable device, such as an ipod, tablet, or smartphone. Order online ( or by phone at (877) of the product may be sterile. For example, the skin prep applicators have packaging that states: applicator is sterile if package is intact. However, Dolan and her team discovered that in this case, the applicator was sterile but the solution inside the applicator was not. On November 18, 2010, the Children s Colorado lab confirmed that every APP analyzed initially contained gram-positive rods of B. cereus. The saline syringes and the 2 percent CHG/70 percent alcohol applicators did not grow any organisms, including B. cereus. Dolan immediately contacted the Colorado Department of Public Health and Environment (CDPHE) to alert the department to this finding. The same day, the Children s Colorado lab tested the outside and inside of the APP packages that had been subjected to sterilization conditions, to determine where the B. cereus was originating. Upon completion of the low temperature sterilization cycle, no gram-negative organisms were found on the outside of the package; however, gram-positive rods were growing on the inside. When I reviewed the literature, it amazed me the number of outbreaks that have been associated with Bacillus species, of which some were pseudo outbreaks and others true outbreaks, said Dolan. She explained that this 46 AUTUMN 2011 Prevention

4 species has been associated with contaminated gloves, hospital linens, gauze, blood culture bottles, and incontinence pads. And because Bacillus species involve spores that cannot be killed by alcohol, it is not surprising that it was viable in the APPs, said Dolan. Children s Colorado immediately launched an internal recall on November 19 and sequestered the product to store it in a safe location; Dolan and the team also immediately found a replacement product that was not manufactured by Triad Group. Children s Colorado had to confirm with the distributor of the replacement APPs that they were not from the Triad manufacturer; Dolan noted that this information is not always clearly marked on the product. The secure storage process for the recalled/ quarantined APP product was really helpful in our situation because it aided the FDA [Food and Drug Administration] investigation, said Dolan. We even put large plastic wrap around the APPs to ensure that they weren t being tampered with. Subsequently, on November 23, CDPHE notified the Centers for Disease Control What is interesting to me is that I always thought of these products as completely sterile, said Dolan. What I learned is that if a package doesn t clearly say sterile, the product may not be sterile and/or only some components of the product may be sterile. and Prevention (CDC) and the FDA of the contaminated APPs. The Children s Colorado team didn t stop there. It cultured 10 different lots of APPs manufactured by Triad Group and discovered that 80 percent of the internal contents of the non-sterile APPs grew Bacillus spp. or Bacillus cereus. Eight of the 10 lots cultured were positive and 100 percent of the outside of the packages contained Bacillus spp. Dolan and her team also thought it was important to get independent validation of their findings; therefore, they enlisted the help of CDPHE to culture the 10 lots of non-sterile APPs and the replacement sterile APPs in their own laboratories. CDPHE confirmed that 10 of the 20 nonsterile APPs from six of 10 lots grew Bacillus spp. It was further discovered that this organism was adherent to the pad itself, said Dolan. By contrast, zero of the 10 sterile replacement product APP lots grew Bacillus spp. On November 30, the State Health Department in Colorado put out a notice via a routinely distributed publication alert called Hot Topics, which notified hospitals in Colorado of the apparent B. cereus contamination of the alcohol pads, said Dolan. During the launch of the hospital s internal recall and communications with the federal agencies, the team ran into challenges and The investigation team at Children s Colorado acted quickly to determine the source of Bacillus cereus infections in the facility s vulnerable pediatric patients. Prevention AUTUMN

5 PHOTO BY PHOTOEUPHORIA / istockphoto.com bumps in the road. Retrospectively, I wish we had a list of all the individual locations in which the APPs were located and how much each location returned, Dolan explained. Nurses returned the recalled product in original boxes and returned the loose APP packages in bags. Of note, the lot number was not on the individual APP packages. This became important because on Thanksgiving Eve, we were at our facility counting and sorting all the APPs for the FDA. In a matter of a couple of days, the FDA wanted to know how many APPs were still in boxes, the lot numbers, and the manufacturing year. They needed this information to get an adequate representation of the wipes for their own testing. Approximately one month later, the FDA issued a news release about the Triad APP recall. The news release was issued on January 5, just a few days after the manufacturer s voluntary recall announcement. This caused a lot of stir, said Dolan. There were a lot of questions around the country. On February 1, the FDA issued another news release in which Karen Weiss, MD, director of the Safe Use Initiative in the FDA s Center for Drug Evaluation and Research, said: Healthcare professionals should always check the labeling on a prep pad to determine if it is sterile or non-sterile. Non-sterile pads are not intended to prep patients prior to procedures requiring strict sterility measures and should not be used on patients with a depressed immune system, to prep patients for catheter insertion, or to prep patients prior to surgery. I m not sure they were clear, said Dolan. I thought that was an interesting comment, because I am not so sure many people would use alcohol as their surgical skin prep [instead of 2 percent CHG/70 percent alcohol solution]. Subsequently, the FDA issued another news release on April 6 explaining that the agency had seized more than $6 million in products from Triad Group s Wisconsin facility. The manufacturer was found to be in violation of the FDA s good manufacturing practices, which are intended to maintain the purity, safety and quality of manufactured drugs. Multiple violations, which were discovered during the FDA s inspection in March, were noted in the news release, including continuing

6 problems with the air handling system; failure to adequately investigate drug products that did not meet specifications, affecting the majority of the products manufactured at the facility; and failure to take the proper measures to ensure the quality of incoming components. Finally, on June 10, 2011, the U.S. Court of the Eastern District of Wisconsin and the Department of Justice Office of Consumer Protection issued a permanent injunction on Triad Group and H & P Industries, Inc. Both companies are managed and owned by the same individuals. Dolan said the problem was that, prior to this incident, most people including healthcare professionals didn t realize that non-sterile alcohol wipes existed. It was previously assumed that all APPs were sterile, she said. Additionally, labeling regarding sterility, non-sterility and the manufacturer was not clear on the recalled APPs, which only added to the confusion. Many of these recalled wipes didn t have the Triad name on them, which was difficult for us, said Dolan. Something in the system could potentially be fixed to help us to get through that process much faster. I think it would have been helpful if the manufacturer s name was somewhere on the wipe so that we didn t have to trace it back ourselves. Dolan maintains that this recall would not have been possible without the cooperation and work of the entire Children s Colorado team during the outbreak investigation. Children s Colorado Epidemiology and Infectious Diseases teams meet daily in the microbiology lab to review and discuss new patient cultures. The expertise of these folks, along with an astute and sophisticated microbiology staff, has prompted various investigations over the years, some of which have led to product recalls and notifications alerts, said Dolan. This investigation has many lessons for the practicing infection preventionist. First, when something doesn t seem right, even if it involves a single case, it warrants a critical look at the issue. When evaluating products for sterility, be sure that if the single word sterile is not on the package, the entire contents inside are not to be considered sterile. Dolan also explained the importance of alerting the local health department to investigations so it can assist in detecting and/or confirming the results, and the need to notify the proper authorities when results have been validated. Any time you perform a recall due to your suspicions of contamination or tampering, be sure to secure the product and conduct an inventory in case regulatory or government agencies will need access to the contents, said Dolan. Maintain daily logs of your activities and document findings accordingly. Finally, utilize the Outbreak Investigation chapter in the APIC Text of Infection Control and Epidemiology (3rd Edition) to help guide your process and confirm that you have covered all of the necessary areas of this important work. Thanks to the vigilance and quick action of Dolan and the Children s Colorado team, lives were protected not only in the U.S., but all over the world. After all, it is the safety of our patients, staff and visitors that drives the work we do each and every day, she said.