Special Report: Dental Debacle in Tulsa

Infection preventionists are all too aware that a dangerous array of infections are moving across all sectors of the health care continuum, as patients undergo treatment and even invasive procedures in settings beyond the hospital that include ambulatory care clinics, physician offices and dental practices. Concerning the latter, we now have another nationally publicized misadventure in dentistry, with some of the most extraordinary lapses in infection control reported in recent memory. As a result, the first case of HCV transmission between patients occurred in the Tulsa practice in question, and investigators expect more infections to be discovered due in part to the cavalier use of multidose vials in the office.

OK investigators: ‘Gross negligence’ in infection control leads to first HCV cross-transmission case in dentistry

At least 61 patients positive so far for HCV, HBV, HIV

By Gary Evans, Executive Editor

The index case of hepatitis C virus (HCV) that triggered a massive testing effort of patients in a Tulsa, OK dental practice rife with infection control failings appears to be the first documented case of HCV infection via cross-transmission between patients in a dental office, Hospital Infection Control & Prevention has learned.

The investigation into the dental and oral surgery practice of Wayne Scott Harrington, DMD, began after public health officials discovered one of his patients recently tested positive for hepatitis C virus with no other known risk factors (i.e., IV drug use). The subsequent investigation revealed a staggering array of alleged infection control violations, including the kind of misuse of needles and multidose vials that have resulted in cross transmission of bloodborne infections between patients in pain clinics, endoscopy centers and hospitals. In inspections conducted while the office was still open, public health officials also observed multiple sterilization issues, dental assistants providing IV sedation procedures, and the drug cabinet unlocked and unattended.1

While epidemiologically historic, the first documented case of HCV cross-transmission in dentistry has a troubling corollary: More than 3 million people in the United States have chronic HCV, many of whom are asymptomatic but have circulating virus that can be transmitted by blood. Some untold number of them are entering dental settings every day, potentially exposing other patients in offices that have lax infection control safeguards.

“At this juncture, it’s difficult to say whether patient-to-patient transmission of HCV in dental surgical settings is extremely rare or whether there are more occurrences nationwide that have gone unrecognized because dental surgical practices have not been scrutinized as closely as other outpatient medical facilities for healthcare-associated transmission of bloodborne pathogens,” says Kristy Bradley, DVM, MPH, lead investigator in the case and state epidemiologist at the Department of Health in Oklahoma City.

After discovery of the index case and subsequent investigation of the dental office, public health officials urged some 7,000 former patients of Harrington to be tested for HCV, hepatitis B virus and HIV. In results for the first 3,122 people tested, 57 of Harrington’s former patients were positive for HCV and another three for HBV. Positive test results were also reported for HIV, but the state’s data security policy prohibits public reporting of numbers less than three for HIV. With that meaning the number of HIV infected patients is one or two, the total number of patients with blood borne infections thus far is at least 61. Of course, the cases may have been infected by risk factors beyond dental care, which has historically rarely been linked to patient infections. The challenge now facing health officials is determining how many of those five-dozen patients that tested positive were actually infected in the dental office.

“Whenever you screen a large number of people for HCV you are going to identify new infections, just because of the back prevalence of this infection in the population,” Bradley says. “So of course we have been getting some positive tests and we are now beginning to investigate those to determine if we have any clustering in time — in terms of procedure dates at the dental [office] — cross-matching that with our HCV registry, and then doing individual case patient interviews to determine if the dental facility was their likely source of exposure.”

For example, health officials estimate that 68,000 people in Oklahoma are infected with HCV, which is the most common blood-borne infection in the United States and the leading cause of liver transplants.

“We are really just in the early phases of the broader epidemiologic investigation as we begin looking for related clusters of dental patients who test positive for viral hepatitis or HIV,” Bradley tells HIC. “We continue to receive about 100 patient specimens for testing daily. We will use molecular testing to evaluate temporal clusters to help identify a source and route of transmission at the Harrington practice.”

More infections linked to office expected

“We think it is likely that we will identify more cases associated with the practice, but it’s too preliminary to provide any more detail,” Bradley says. “We are concerned about injection safety. I think it will come to light as we complete our investigation that people were placed at risk because of improper injection safety practices.”

According to state investigators, opened and unopened vials were found in drawers with needles in the patient care areas. Needles were being reinserted into multidose vials for use on multiple patients, a practice that has been shown to contaminate the medication with blood from infected patients and create “a great risk of cross-contamination,” the state report revealed.

“It was primarily multidose vials that were being used,” Bradley says. “The likelihood that the persons who were administering these drugs routinely had been appropriately trained in how to practice injection safety is in question. “

Particularly concerning was the finding that two uncertified dental assistants were primarily responsible for administering the IV sedation drugs, Bradley says. “That was clearly in violation of the [state] dental practice act and also in violation of our controlled and dangerous drug laws,” she adds.

The IV drugs and a saline flush were administered for major procedures like extraction of wisdom teeth or implants, she notes. “We can speculate that there is a possibility that a patient who was chronically infected with one of the viruses would be given the sedation and then if the assistant had reused the syringe and/or needle and reentered the multidose vial to pull up more medication, then some of that [patient’s blood] back-flushed into the vial,” Bradley says. “Now it contains the blood and the virus and a subsequent patient who would receive that same medication — even though they may use a new syringe and needle to reenter the vial — the medication is contaminated. Then they are essentially injecting that infectious material into the next patient.”

Autoclave untested for years?

If that scenario isn’t disturbing enough, consider this finding when the state investigators asked about routine maintenance of the autoclave used to sterilize instruments — including the recommended monthly testing of the machine using biological test strips. “No such test had ever been performed in the six years one dental assistant had been working at the office,” the report stated.

For an expert reaction to this rather mind-boggling finding we reached out to Roland Arnold, PhD, a professor of diagnostic sciences and dental research at the University Of North Carolina School Of Dentistry in Chapel Hill. After several erudite scientific observations he offered this common-sense conclusion, “I certainly wouldn’t sit in his chair.”

Arnold said the case represents a cautionary tale that may have educational benefits, and it also underscores the need for required infection control training in dental practices. (See related story, below.)

“I hope that the case in Oklahoma was a single incident,” he says. “I know that all of our students — including our dental hygiene and assistant students — would recognize everything cited as an appalling violation of even minimum infection control protocols. This would also apply to all of the practitioners in the state that attend UNC’s regular CE courses on infection control updates. If nothing else the case will allow me to get the attention of our students when I give infection control lectures. Such training with annual updates is mandatory for all of our students and staff.”

Other infections could be missed

While the practices described in the Tulsa office have been widely characterized as a shocking outlier to the vast majority of dental practices, a consultant in the field warns that patients could be at risk in other dental offices — particularly regarding the misuse of multidose vials.

“That is not as uncommon as you might think,” says Noel Brandon Kelsch, RDHAP, of Moor Park CA, a past president of the California Dental Hygienists’ Association. “This is not shocking to me at all — this is not the first case like this. This can happen and that is why patients need to be educated and staff need to be educated.”

Kelsch was referring to a 2002 case of documented HBV transmission between two patients treated on the same day in an oral surgeon’s office in New Mexico. Again, state health investigators found a patient who had none of the traditional hepatitis B risk factors. As the only transmission risk was recent oral surgery, investigators looked into the dental practice and found that another surgical patient seen earlier that same day was on the state’s reportable disease registry for HBV. Both had tooth extractions in the same dental procedure room less than three hours apart. Transmission was confirmed through molecular epidemiology, with the investigators concluding in a 2007 published account of the case that additional “transmission may have been limited by the high prevalence (64%) of patients vaccinated against HBV.”2 In sharp contrast to the Tulsa office, they found no infection control problems in the New Mexico practice, including the handling of multidose vials.

“The investigators could only speculate that a lapse in procedures had occurred after the source patient left the area contaminated with blood,” says Kelsch, a registered dental hygienist in alternative practice. “This and other cases remind us all how imperative infection control protocols are. This reminds us that our infection control is only as good as the worst action we take.”

Many hepatitis cases lack risk factors

While the rare occurrence of hepatitis infections linked to dentistry certainly underscores that the majority of offices are following infection control precautions, it is also true that intermittent transmission of viral infections in outpatient settings can easily go undetected due to inadequate state surveillance systems and the lack of public health resources to investigate individual cases. These infections may ultimately be counted among hepatitis cases of unknown origin, but they are not being traced back to transmission in health care settings. For example, the Centers for Disease Control and Prevention has estimated that 50% of patients with acute HCV and HBV are reported without accompanying risk factor data. Among patients for whom risk factor data were reported, 56% with acute HBV infection and 32% with acute HCV infection could not specify a known risk factor for their infection (i.e., injection drug use, sexual or household contact with another infected person, occupational exposure to blood, or needlestick injury.)3,4

Speaking of needlesticks, could there be another route of transmission — possibly involving an infected health care worker? As this issue went to press, Harrington had not consented to a public health request to be tested for bloodborne viruses, Bradley says. “We recently requested in writing that he be tested,” she says. “We are hopeful that he will come forward and agree to be tested. We also are working to accomplish testing of all of the dental assistants that were working there at the time.”

The state dental board temporarily suspended Harrington’s license after the investigation and the dentist faces a hearing in August that could result in full revocation. His attorney James K. Secrest II in Tulsa, recently issued the following statement: “For almost 35 years, Dr. Harrington has provided Oklahomans with dedicated oral surgical care. His previous record with the dental board is impeccable. He is taking the recent allegations very seriously and is fully cooperating with the Oklahoma Dental Board. At this time, out of respect for his patients and the sensitivity of the issues, Dr. Harrington will make no further comments on this matter.”

Taken in light of recent revelations, the duration of his dental practice is not necessarily reassuring. “We only have records back to 2007,” Bradley said. “We have reached out through the media to inform any people who may have been dental patients prior to 2007 that they may still be at risk because these improper infection control practices appear to be longstanding. We don’t have a defined time period.”

The patients who have tested positive will be personally contacted by public health officials and counseled about information specific to the disease in question. Health officials assured that they will be directed to resources for appropriate care and follow up, including if warranted, testing of spouse or partners.

Ghosts from the past

Regarding the few HIV positive patients in the dental practice, health officials estimate that nearly 5,000 people are living with HIV/AIDS in Oklahoma. While it is not likely that the HIV-positive patients acquired the virus in the Tulsa dental office, the positive tests recall the infamous Florida Dental Case in 1990, when the late Kimberly Bergalis and five other patients contracted HIV after receiving care from an HIV-positive dentist. The case was never definitively solved — partly due to the absence of dental records — though the initial molecular epidemiology seemed to suggest the patients were infected by the HIV-positive dentist, the late David Acer, DDS of Stuart, FL.5,6 In a report at the time, HIC raised the possibility of cross-transmission of HIV between some of the patients. There were at least 10 HIV positive patients in the practice and the dentist also occasionally treated IV drug users referred by a rehabilitation clinic.7 Subsequent investigations could not definitely link the dentist nor other patients to the cluster of infections, resulting in theories and articles suggesting the patients were all infected independently in the community or even intentionally infected by the dentist. In any case, there does not appear to be any documented case of HIV infection transmitted during dental care in the United States in the wake of the Florida cluster. A commonly cited explanation for that is that HIV does not survive long outside of the body, though HCV and particularly HBV can remain viable in the environment for longer periods.

“You can expect some of these viruses to survive a little bit of time on environmental surfaces,” says Bradley. “For HCV that is three or four days, a week or potentially longer for HBV. But HIV, fortunately, doesn’t exist very well for very long outside the human host.”

Harrington told investigators that many of the patients under his care had bloodborne infections.

“A statement was made by the oral surgeon that he knew that he had a fairly high prevalence of HBV, HCV and HIV in his patients,” Bradley said. “I guess that he knew that [many patients] had Medicaid as their insurance. Some health care workers aren’t as willing to accept Medicaid patients, but he prided himself on catering to that population.”

Would that he had taken a similar pride in rigorous infection control practices. According to the state investigation report, “Dr. Harrington referred to his staff regarding all sterilization and drug procedures in the office.” That resulted in the allegation of “committing gross negligence in the practice of dentistry specifically by deferring all decisions and supervision of cleaning, infection control and turning over all inventory and maintenance of scheduled and legend drugs to dental assistants.”

According to investigators, when Harrington was asked about the responsibility for such practices he said, “They take care of that, I don’t.”

References

1. Oklahoma Board of Dentistry. Statement of complaint against Wayne Scott Harrington, DMD. March 28, 2013. Available at: http://www.ok.gov/dentistry/

2. Redd JT, Baumbach J, Kohn W, et al. Patient-to-Patient Transmission of Hepatitis B Virus Associated with Oral Surgery. Infect Dis 2007;195(9):1311-1314.

3. Centers for Disease Control and Prevention. Surveillance for acute viral hepatitis—United States, 2006. MMWR Surveill Summ 2008;57:1-24.

4.Thompson ND, Perz JF, Moorman AC, et al. Nonhospital Health Care-Associated Hepatitis B and C Virus Transmission: United States, 1998-2008. Ann Intern Med 2009;150:33-39.

5. CDC. Possible transmission of human immunodeficiency virus to a patient during an invasive dental procedure. MMWR 1990;39:489-493.

6. CDC. Update: Possible transmission of human deficiency virus to a patient during an invasive dental procedure – Florida. MMWR 1991;40:21-33

7. Evans G, Bland A. Unreported findings shed new light on HIV dental case. Hospital Infection Control. 1991;Vol 18(7):85-108.

Infection control best practices for dentistry

IPs may field a few questions on Tulsa case

In light of the Tulsa dental case and ensuing patient questions, dental consultant Noel Brandon Kelsch, RDHAP, of Moor Park CA, a registered dental hygienist in alternative practice and past president of the California Dental Hygienists’ Association, recommends the following essentials to ensure proper infection control in dentistry:

• Inform patients that the practice uses evidence-based infection control precautions as recommended by the Centers for Disease Control and Prevention. The latest recommendations and other resources can be downloaded from the CDC. (http://www.cdc.gov/OralHealth/infectioncontrol/)

• Explain that dental anesthetics are provided using sterile single-use needles and cartridges of anesthetic and that these items are properly discarded after each patient.

• If IV medications are used, explain that these medications are either from single-dose vials, or multi-dose vials are accessed only once with a single needle and syringe, and that additional medications, even for a single patient, are drawn with a new syringe and needle.

• Explain the sterilization process, including thorough cleaning, examination and then sterilization of instruments.

• Reassure patients that instruments are maintained in sterile pouches or wraps until they are needed for patient care. It may be particularly useful to only open pouches once patients have arrived, so they may see for themselves that the instruments are properly packaged.

• Discuss the processes used for sterility assurance, including chemical indicators on and/or in packs of instruments, and the regular monitoring of the sterilization process though the use of a biological indicator (spore test).

• Reassure patients that all procedures requiring licensure or certification are provided only by professionals licensed to provide those services. More information may be found through the American Dental Association at http://www.ada.org/news/8459.aspx


An urgent need for dental infection control training

OSHA training reg commonly ignored

The Tulsa dental investigation underscores the need for more education and oversight of dental health care workers, who are not required to have infection control training in Oklahoma, says Kristy Bradley, DVM, MPH, lead investigator in the case and state epidemiologist at the Department of Health in Oklahoma City.

“Any inspections of the licensed dental practices are complaint driven,” she says. “So as long as there are no public complaints, there are no inspections. There also is no requirement for infection control training, and that is something that we are looking at pursuing through the Oklahoma Dental Association and the state Board of Dentistry. [One thought is] to have some periodic requirements as a continuing education unit in infection control. I think that would be a step in the right direction.”

According to the American Dental Association, regulations for dental office inspections are determined on a state-by-state basis by the state dental board.

Noel Brandon Kelsch, RDHAP, of Moor Park CA, a registered dental hygienist in alternative practice and past president of the California Dental Hygienists’ Association, said her state requires infection control training, but there are other states like Oklahoma where none is required.

“We petitioned in California so that unlicensed dental assistants are now required to have eight hours of infection control training,” she says. “I think that should be required in every single state. Anyone who steps on a clinic floor should have eight hours of [infection control] training.”

Moreover, existing regulations by the Occupational Safety and Health Administration are rarely enforced in dental settings, she adds.

“In the U.S. it is required by law that every single dental office has OSHA training every year on bloodborne pathogens. They are simply not doing it,” Kelsch says. “They also have to have a written infection control program in place. Patients need to know about this. They need to know that they have to have OSHA training and ask when they had it.”

Noting that she sometimes talks to patients and fellow hygienists who observe poor practices in a dental setting and simply decide not to return for care, Noel says “it is our responsibility to report and to be a part of the change.”