After a series of highly publicized drug diversion incidents by healthcare workers and patient outbreaks in Colorado in recent years, the state has passed a law that requires surgical technologists to register and submit to background checks.
Effective Aug. 10, 2016, Colorado law (House Bill 16-1160) requires that surgical techs pass a criminal history check and submit fingerprints to the state Bureau of Investigation. The law also stipulates that employers requiring surgical techs to take a drug test must forward any positive results for a non-prescribed controlled substance to state officials.
In the latest of a succession of incidents in Colorado, last year the state charged an HIV-positive surgical technician with stealing opioid drugs, leading to a recommendation that some 3,000 patients at Swedish Medical Center in Englewood be tested for bloodborne viruses.
Colorado may now have the strongest law in the land to address what is clearly a national problem. Addicted healthcare workers are another spectrum in a tsunami of national opioid addiction. Surgical techs that are “travelers” or agency workers have been able to go from hospital to hospital, even in cases where they have been discovered diverting drugs and fired. Hospitals fear liability and bad publicity in drug diversion incidents and may fire workers without pursuing public prosecution. In the most recent incident in Colorado, the surgical tech allegedly falsified his job history and resume to leave no trail back to past incidents.
“When hospitals detect this, they find that these surgical techs have been at numerous other facilities, not just in our state but throughout the country,” says Susan Dolan, RN, MS, CIC, president of APIC and epidemiologist at Children’s Hospital Colorado in Aurora. “Colorado has passed this legislation now requiring background checks and fingerprinting, and this is something we need to do nationally. These folks only stay until they get caught and then there is no way to track them.”
In the most egregious case to date, an HCV-infected traveling radiology technician was linked to a cluster of HCV patient infections at a New Hampshire hospital in 2012. The subsequent investigation uncovered a large HCV outbreak spanning several years, involving more than a dozen hospitals and affecting thousands of patients in eight states. The technician was stealing syringes filled with narcotics, self-injecting, refilling them with saline, and placing them back into the procedure area, officials reported. He was sentenced to 39 years in prison.
According to the CDC — in what is certainly an undercount of actual infections — there have been an estimated 100 patient infections and 30,000 potentially exposed patients via drug diversion reported in U.S. healthcare facilities over the last decade.1
With a history of drug use, the diverter is often infected with HCV or other bloodborne pathogens. They then contaminate syringes and solutions in diverting drugs, setting off outbreaks among patients that are often the event the leads to their arrest. In the absence of an outbreak, ongoing sporadic infections and other patient harms are largely going undetected because bloodborne infections may not be discovered for some time, perhaps not until a patient later gets a blood test for something else. If the patient has no risk factors for HIV or hepatitis, they are understandably mystified and alarmed that they have acquired a serious infection.
In a position paper issued earlier this year, APIC recommended that healthcare settings “institute drug diversion monitoring systems and security measures to assist in averting and/or identifying diversion activity. CDC defines an appropriate response to a drug diversion event as including [an] ‘assessment of harm to patients, consultation with public health officials when tampering with injectable medications is suspected, and prompt reporting to enforcement agencies.’”2
There are commercially available programs that keep track of drug inventories, document access, and reconcile unused drugs and “waste,” Dolan says. “Periodically, some pharmacies test the leftover drugs so you can be sure that someone is not sending back saline as the leftover,” she says. “The other thing is to be astute on the front lines, be aware of patients that do not seem to be under good pain control.”
APIC also cites a common risk factor for diversion in some facilities that prefill syringes and IV solutions in advance to be ready for a scheduled procedure. Of course, therein lies the temptation to the drug diverter, who has been described as the type of worker who may come in early and work late. Therefore, APIC warned against these prefilling practices, recommending that injectable meds be prepared as close as possible to their time of clinical use.
“We tried to put our position paper in a practical format for frontline use,” says Dolan. “[We are addressing] how things really happen on the frontline. There are people you wouldn’t suspect who are diverting. The people who come in early and stay late. The people who sign up for a lot of overtime. That’s one extreme, and on the other there are people who aren’t performing well and always seem lethargic. But some of these people are high performers. You wouldn’t suspect them, and they build trust to gain access.”
Injection Safety 101
Beyond the diversion issue, the APIC paper addresses a vexing and frustrating problem that continues to occur with shocking regularity. Clinicians who should know basic injection safety and proper infection control measures time and again ignore some essential step and expose patients to each other’s blood via reused needles or contaminated vials.
“We’re still continuing to see these issues, but I think what we are finding is the majority of these are happening in facilities outside of hospitals — in the community in small practices, in long-term care facilities and nursing homes,” she says.
Dolan shares a cautionary tale of a healthcare worker in Colorado who was administering influenza vaccine that was to be given in two doses to young pediatric patients. “The medical assistant was delegated to give the shots and knew how to do the technique, but didn’t understand the ramifications of how she was doing the procedure and handling the medication,” she notes.
Seizing on the idea that two doses were needed, the healthcare worker gave each child a partial dose and then saved the remainder in syringes labeled “second dose” in a bin in the clinic refrigerator. No child’s name or identifier was on any of them.
“She took the syringe, put a clean needle on and put it in the bin as the second dose, figuring since I changed the needle it’s safe for the next patient, whoever needs their second dose,” Dolan says.
As infection preventionists are well aware, changing the needle does not solve the problem as minute levels of blood aspirated into the syringe solution could transmit hepatitis C and other infections between patients. The APIC paper recommends the following steps as a kind of injection safety 101:
- Never use a syringe for more than one patient, even if the needle has been changed between patients.
- Use a new sterile syringe and a new sterile needle for each entry into a vial or IV bag.
- Use sharps safety devices to give injections whenever possible.
- Discard syringes, needles, and cannulas in a sharps container immediately at the point of use.
- Discourage transporting medication-filled syringes in pockets or clothing.
- Label all syringes containing medication if not immediately administered. Include patient identification information, names and amounts of all ingredients, and the name or initials of the preparer.
Vial Issues
Another problem is reuse of vials labeled single-use, as some may be large enough to contain more of the medicine. Citing multiple outbreaks, the FDA is proposing label changes and creating a new category of vial called “single-patient-use.”3
“In the past, the term ‘single-use’ container has been used by FDA to describe a package type that contained multiple doses but was intended to be used in a single patient,” the agency states in the proposed rule. “Unfortunately, the term ‘single-use’ was also inappropriately used as if it were interchangeable with the term ‘single-dose’ which was not the agency’s original intent. To address this confusion regarding the terminology, the [FDA] is retiring the term “single-use” and a new package type term ‘single-patient-use’ container, is being created to address the need for describing a package that contains multiple doses of an injectable medical product that is intended to be used in a single patient.”
While there has certainly been confusion about medication vials, there has also been a certain level of greed as facilities adopted dangerous practices to scavenge meds. The most infamous example was the 2008 hepatitis outbreak at a Las Vegas endoscopy clinic, where workers were using single-dose vials of propofol on more than one patient. The practice had been going on for years, and tens of thousands of patients were advised to seek testing for HIV and hepatitis.
“I do think some of it is to save money — there is still that incentive,” Dolan says. “Medications cost a lot of money and they are not [being manufactured] in ways that you are able to just give a single dose and then throw it away.”
The problem has also been exacerbated by drug shortages in some cases. The FDA has not issued a final rule on its proposed changes, but APIC submitted comments to the agency urging them go further and require design changes in certain vials to block unsafe reentry. “FDA [should] consider providing additional requirements in the near future for industry on Single-Dose containers such that re-entry or reuse of such containers is prohibited by product design features. … [T]here are instances where a single-dose container may contain more drug than is required by a single dose, but is not intended for use following removal of a single dose.”4
In the interim, IPs should continue to be vigilant for unsafe injection practices and drug diversion incidents during rounds in their facilities, Dolan says.
CMS includes basic injection safety aspects in hospital inspections using its infection control worksheets. That will certainly add pressure for compliance with aseptic technique, she adds.
“All of these [CMS] infection control worksheets that we are starting to see put into place actually have very specific components [on injection safety] for their inspectors,” Dolan says. “It is a red flag and it escalates the issue within the state for [facility] certifications. I think putting teeth into this is really helpful.”
REFERENCES
- Schaefer MK, Perz JF. Outbreaks of infections associated with drug diversion by U.S. health care personnel. Mayo Clin Proc 2014;89(7):878-87.
- Dolan S, Arias KM, Felizardo G, et al. APIC Position Paper: Safe Injection, Infusion, and Medication Vial Practices in Health Care. 2016: http://bit.ly/2aWtJJv.
- FDA. Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use: Guidance for Industry: Draft Guidance: Oct. 2015: http://bit.ly/2aH05TA.
- Manning, ML. APIC Comment to FDA Re: Docket No. FDA-2015-D-3438. Dec. 17, 2015: http://bit.ly/2b8NE3O.
After a series of highly publicized drug diversion incidents by healthcare workers and patient outbreaks in Colorado in recent years, the state has passed a law that requires surgical technologists to register and submit to background checks.
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