CTC Clinical Procedures incident information

April 11, 2014

Marmian Grimes

The University of Alaska Fairbanks is conducting an investigation and procedure review after students in a Clinical Procedures II class in the UAF Community and Technical College medical assisting program reported that they had been practicing giving injections to each other using a solution that is not designed for use in humans. This page will be updated as new information becomes available.

Background

The University of Alaska Fairbanks administration learned on March 6 that students in the spring 2014 Clinical Procedures II received practice injections with a substance referred to as “Demo-Dose” that was not meant for human use. Demo-Dose solutions are designed to be used on mannequins or injection pads, not on humans.

In the course of investigating this incident, the university became aware of information indicating that students in prior classes taught by this instructor may have received practice injections with a non-injectable solution. It now appears that Fall 2013 students also received injections with the same solution. As a result, the university notified all students who took this particular class from this particular instructor back to her start date with the university in 2006.

The information that the university has gathered so far does not necessarily indicate that all students who took Clinical Procedures II from this instructor received practice injections with an inappropriate substance. Our records indicate that practice solutions appropriate for human use may have been in use for several years, but also that some prior semesters’ students may have been injected with a substance similar to Demo-Dose. Those records indicate that a solution from the same manufacturer was also being used in 2010. During other years, the program was ordering solutions from a different company. The university is still working to obtain the contents of the past solutions.

Employee statements indicate that some students in 2010 complained of pain, burning and skin irritation at the injection site. Employee statements and purchasing records indicate that, in 2010, employees had purchased and used a solution from the same supplier that was later used in 2013 and 2014, and that after receiving student complaints, they determined that the solution was not appropriate for injection in humans. Records and employee statements indicate that as a result, the employees changed suppliers in early 2011. Unfortunately, this issue does not appear to have been communicated to students or to UAF administrators. Inexplicably, in 2013 the employees changed suppliers back to the 2010 supplier, which the university has determined does not make solutions appropriate for injection into humans.

The injected solutions

Records indicate that the type of solution that the fall 2013 and spring 2014 classes used was ordered in March and September of 2013, respectively. The manufacturer has said it contains water and 0.5 percent isopropyl alcohol, commonly known as rubbing alcohol.

UAF contracted with a laboratory to to test 11 in-use vials of solution from the spring 2014 semester and one unopened vial from the same manufactured lot for bacterial and fungal growth.

The test results for fungus were negative, meaning that the samples provided from the spring 2014 Clinical Procedures II class did not contain fungus.

All 12 vials grew bacteria of the genus Brevundimonas, either B. vesicularis (7 vials), B. diminuta (1 vial), or both of these species (4 vials, including the unopened vial). These findings suggest that the vials of injection solution were contaminated with Brevundimonas bacteria during the manufacturing process.

Brevundimonas species are environmental bacteria that are most commonly found in water. They rarely cause infection in humans, and most cases of infection have occurred in people with weakened immune systems or have been associated with medical devices, such as intravascular catheters.

In one student’s vial, the presence of two types of water-associated organisms, Aeromonas hydrophilia and Rhizobium hydrophilia, was also detected. This finding suggests this one vial may have become further contaminated during repeated use in the classroom. Because only one student’s vial contained these two bacteria, the university is individually providing that student with information pertaining to those two organisms.

There is no way to know whether past classes’ solutions contained the bacteria, as we do not have samples from most past classes.

Reported symptoms

Reports have included stinging, burning and severe pain during the actual injection. Students have complained of subsequent skin irritation, including itching, rashes, discoloration, scarring and divots at the injection site. We have also received reports of stomach pain and numbness. These are the reports the university has received, not what we have verified or what students should necessarily expect to experience. We also cannot say with any surety that the reports are necessarily symptoms or the result of being injected with the solution. The university is recommending that students who believe they have or had symptoms consult with their medical provider.

University response

Students have told the university that they reported their symptoms and concerns about the solution to their instructor and teaching assistant, however it appears that those concerns were not shared beyond the program. In addition, students have said that they were told to continue using the solution, despite their concerns. This is not in compliance with university incident reporting expectations.

The UAF administration became aware of the issue when the manufacturer of the solution sent the university a letter saying that the solution should not be used for injections in humans.

Since that time, the university has met with Spring 2014 and Fall 2013 students and has sent a letter to all students who took Clinical Procedures classes with the instructor since 2006, and has established a website to share information and allow students to submit their questions and concerns. The university is working with current and former students to address their health concerns, including paying for medical testing and offering services at the UAF Center for Health and Counseling, and is providing additional support for current students so that they are able to complete their degree program in a timely manner. Multiple vials of the solution used in the class are being tested by an independent lab.

Investigations and reviews

The university is conducting both a human resources and a general investigation of the incident. In addition, multiple reviews of procedures and practices have begun or will begin shortly. Those reviews will focus on allied health classroom procedures and practices, incident reporting and response procedures throughout UAF, and purchasing and inventory control procedures.