In wake of high-profile cases involving theft of controlled substances, healthcare providers take collaborative approach to prevention
If the multistate outbreak of hepatitis C that has infected more than 30 patients and necessitated the testing of thousands more has a silver lining, experts say it's that it has prompted healthcare providers to begin to look more closely at the issue of theft of controlled substances—known as drug diversion—in their own facilities.
The outbreak, which has affected primarily patients who received treatment at 97-bed Exeter (N.H.) Hospital, has been traced to David Kwiatkowski, a traveling medical technician infected with the disease who was employed in Exeter's cardiac catheterization lab from April 2011 until May of this year.
Kwiatkowski, who was arrested in July, allegedly stole syringes containing the powerful painkiller Fentanyl, injected them and then refilled the contaminated syringes with another solution. Upon his arrest, U.S. Attorney John Kacavas said the evidence pointed “irrefutably” to Kwiatkowski, calling him a “serial infector.”
On Nov. 28, a federal grand jury indicted him on 14 charges, seven counts each of obtaining controlled substances by fraud and tampering with a consumer product. On Dec. 3, Kwiatkowski pleaded not guilty to the charges in federal court.
During the course of more than five years, from January 2007 until his dismissal from Exeter this year, Kwiatkowski worked as a technician at 18 hospitals in seven states. During that time, he was allegedly involved in multiple drug diversion-related incidents, including one at Arizona Heart Hospital in Phoenix, where he was employed for 11 days in March and April 2010.
Kwiatkowski was fired after a fellow employee found him passed out in a men's locker room with a Fentanyl syringe and needle, a hospital spokeswoman said. He failed a subsequent drug test, she added. Following his dismissal, Kwiatkowski also relinquished his state radiologic technician license, but was able to find a new job soon after at a hospital in Pennsylvania.
Kwiatkowski's ability to move to other states and find new employment despite such incidents highlights the pressing need for better communication among facilities and a regularly updated national registry of healthcare workers, hospital officials say.
“While information continues to be learned about this individual's past and his alleged activities, we support efforts to create a national standard of information sharing that would allow hospitals like HaysMed to have a full picture of a person's work history and any previous issues before employment,” Shea Veach, vice president of regional operations at 157-bed Hays (Kan.) Medical Center, where Kwiatkowski was employed for several months in 2010, said in an e-mail.
Exeter officials could not be reached for comment, but in a Nov. 18 letter to the Boston Globe, Kevin Callahan, the hospital's president and CEO, called it reprehensible that Kwiatkowski “was properly credentialed with a clean services record when he arrived on our doorstep in New Hampshire.”
“This must never be allowed to happen again, anywhere else,” Callahan added in the letter.
The case has triggered worry among hospitals, which remain unsure about the scope of the problem of drug diversion, its potential to harm patients and whether they have safeguards in place to prevent it. But other hospitals and some state agencies are ahead of the curve and have found success in tackling the problem head-on.
The Mayo Clinic, for example, has been refining its approach to spotting and preventing diversion for more than a decade, says Dr. Keith Berge, an anesthesiologist at the health system's hospital in Rochester, Minn. In July, Berge, Kevin Dillon, the Mayo Clinic's director of pharmacy services, and several others authored an article in Mayo Clinic Proceedings that reviewed the potential harm associated with drug diversion and outlined the system's best practices.
Their strategy, Berge says, includes the use of automated distribution machines for controlled substances, secure waste bins for unused portions of drugs and periodic audits of drug waste to ensure leftover amounts and concentrations correspond with dispensing records.
After implementation of the changes, the number of known incidences of diversion fell to almost zero, Berge says, adding that there have been only two such events in the past 12 years, compared with approximately one or two a year before the new protocols were instituted.
“We didn't anticipate that kind of drop,” Berge says. “I think it puts just enough of an impediment in people's minds. They know we're always watching.”
Berge argues that drug diversion should always be framed as a patient-safety concern rather than a problem of drug enforcement or human resources. “This is truly a patient-safety issue,” he says. “It is a catastrophic thing for a patient to contract hepatitis C in this way and it shouldn't happen.”
Mayo Clinic's experiences with drug diversion were featured at an Oct. 25 conference organized by the New Hampshire Hospital Association. Officials from the association organized the event in response to concerns from members, says Steve Ahnen, the hospital association's president.
The conference drew more than 200 attendees from across the state, including physicians, pharmacists, risk managers, human resources professionals and hospital leaders. “We don't want to reinvent the wheel,” Ahnen says. “We want to learn from other institutions that have experienced similar cases of drug diversion. What are they doing differently, and given their experiences, what would they recommend to us in terms of steps that should be taken?”
Mayo's Dillon explained to attendees how the 21-hospital system redesigned its policies and procedures in the wake of several instances of drug diversion, including one involving a nurse who stole Fentanyl and replaced it with saline solution.
Dr. David Theil, chairman of the anesthesiology department at Rose Medical Center, Denver, and Robert Campbell, a pharmacist and Rose Medical Center's vice president of operations, also spoke at the conference about the hospital's response to a much-publicized 2009 event, when a surgical technician who was fired for drug diversion—and who found a new job in Colorado Springs two weeks after the firing—was found to have diverted Fentanyl and in the process, infected more than 30 patients with hepatitis C. That technician, Kristen Parker, pleaded guilty to charges of tampering with a consumer product and fraudulently obtaining a controlled substance and is now serving a 30-year prison sentence.
“The sharing at the event was phenomenal,” says Anne Diefendorf, vice president for quality and patient safety at the Foundation for Healthy Communities, Concord, N.H., a sister organization of the hospital association. “No one left without a to-do list.”
While it's difficult to know exactly how big of a problem drug diversion in healthcare facilities actually is, experts say it's endemic.
Joseph Perz, an epidemiologist with the Centers for Disease Control and Prevention, contends that diversion of controlled substances affects all hospitals. He says he came to that conclusion after spending years helping state health departments investigate drug diversion cases.
“It's a very large problem with many dimensions,” says Perz, who participated with Dillon and Berge on a September webinar on the topic, conducted by the Premier Safety Institute, a division of the Charlotte, N.C.-based Premier healthcare alliance. “The risks to patients were not understood well until recently.”
Berge agrees: “If hospitals are looking for it, they'll find it.”
At an October conference on drug diversion sponsored by the New Hampshire Hospital Association, speakers included, from left, Kevin Dillon of the Mayo Clinic; Dr. David Theil and Robert Campbell of Rose Medical Center in Denver; and Anne Diefendorf of the Foundation for Healthy Communities.
One state that does have available data on the prevalence of drug diversion in healthcare is Minnesota. In May 2011, the state's health department partnered with the Minnesota Hospital Association to form the Minnesota Controlled Substance Diversion Prevention Coalition. The coalition, which includes law enforcement officials, providers and licensers, aimed to identify best practices, increase awareness and share data, says Tania Daniels, the hospital association's vice president for patient safety.
In a prevention roadmap released earlier this year, the coalition outlined more than 100 best practices, many of which were based on the work of the Mayo Clinic, Daniels says. For instance, the roadmap advocates the use of bar-coding technology, camera surveillance in areas where controlled substances are stored, electronic-lock cabinets accessible only by authorized staff members, biometric identification technology in lieu of passwords and regular staff education.
Daniels says those steps are necessary as the scope of the problem worsens.
According to a final report the coalition released in March, reports of theft or loss of controlled substances spiked 325% from 2006 to 2010 among Minnesota healthcare organizations, based on a review of 250 total reports submitted to the U.S. Drug Enforcement Administration. The number of reports submitted each month rose from an average of 1.3 in 2006 to 4.3 in 2010.
And those are just the incidents that were reported, she adds.
Many times, hospitals are reluctant to enlist the help of local law enforcement and the DEA, says Diefendorf, of the Foundation for Healthy Communities. “Typically, we have not had a low enough threshold to report to law enforcement, and this case shows that,” she says, referring to the Kwiatkowski case. “There were a number of places where he was caught red-handed and dismissed, but law enforcement was not brought in.”
Forging collaborative relationships with law enforcement and regulatory agencies early on is critical, says Kimberly New, a compliance specialist at 511-bed University of Tennessee Medical Center, Knoxville, and president of the Tennessee chapter of the National Association of Drug Diversion Investigators. New says her hospital targeted the problem after a diversion-related case in 2009 involving patient harm.
“After we had our case, I became active in the task force and I got to know and build relationships with law enforcement,” she says. “We grew to trust each other, and it took the conflict out of the situation.”
But many hospitals, frightened by a punitive culture, might wait too long to report, New says.
Since the details of Kwiatkowski's diversion have come to light, Exeter has faced the prospect of losing its Medicare provider agreement by the end of the year after two CMS audits conducted in response to the outbreak uncovered deficiencies in infection control and other areas.
At an October news conference, Exeter officials said they were still working on their final action plan to submit to the CMS, following a subsequent audit, but they said they were confident they would be able to successfully address the agency's concerns.
“Ultimately, it will be up to the CMS surveyors to determine if we have met their standards,” according to a statement from Exeter.
The hospital also lost a battle with state regulators to release thousands of patient records, which Exeter officials had argued was a violation of privacy laws. “It's unfortunate because I think facilities need to have a mechanism to report effectively without being beaten up for it,” New says. “There has to be a balance so they're comfortable coming forward.”
She echoed other drug-diversion experts who said the outbreak has sharply increased provider awareness of the problem. She says she is receiving daily requests to speak at conferences, up from just once in a while in past years. And the National Association of Drug Diversion Investigators has already scheduled three healthcare facility diversion training conferences just in the first half of 2013, she says.
New Hampshire isn't the only state that has had to grapple with the impact of Kwiatkowski's actions. Thousands of patients across the seven states where he worked have been tested, and six in Kansas have been identified as having the same strain of the disease as Kwiatkowski, says Charles Hunt, state epidemiologist at the Kansas Department of Health and Environment.
Kwiatkowski worked at Hays Medical Center from May 2010 to September 2010, during which time 474 patients were potentially exposed, Hunt says. Some of those patients have since died, leaving 416 available for testing. About 95% have since been tested, he says.
Veach, of Hays Medical Center, says the hospital is “looking for any possible ways we can enhance our processes and systems based on this unique situation, in addition to standing policies and procedures that address any number of possible scenarios.”
And in November, Maryland health officials confirmed that one patient's strain of hepatitis C could be linked to the New Hampshire outbreak. Kwiatkowski worked in a number of hospitals in the state, including the Baltimore VA Medical Center.
Dr. Lucy Wilson, chief of the Maryland Department of Health and Mental Hygiene's Center for Surveillance, Infection Prevention and Outbreak Response, said in an e-mail that the state had launched a “comprehensive review of public health vulnerability” since the outbreak. She says the review is expected to prompt tighter controls and more patient safeguards.
The New Hampshire Hospital Association followed up its October conference by forming a multistakeholder steering committee composed of representatives from the provider community, risk management, the state's medical society, and the state's boards of nursing, medicine and pharmacy.
“Drug diversion is a significant problem and we want to make sure we're being as inclusive as possible in our approaches to it,” Ahnen says. “Drug testing has been one issue that has come up, as has talk of creating a registry for certain types of healthcare workers. Those are questions we'll be looking at.”
TAKEAWAY: Some hospitals are ahead of the curve in setting up safeguards to limit their vulnerability to drug diversion.