Infection Control: The Cost of Noncompliance

Louis G. DePaola, DDS, MS

June 2014 Issue - Expires June 30th, 2017

Inside Dentistry

Abstract

Although most dentists follow infection-control protocols carefully, a very small percentage either does not or has momentary lapses. The costs of not following guidelines and recommendations can be high, leading to substantial loss of income, causing long-lasting damage to a provider’s professional reputation, and having a long-term impact on the health and well being of patients. Recently, transmission of bloodborne pathogens such as hepatitis B and hepatitis C have been documented in dentistry. Patients depend on dentists to exercise their ethical, moral, and legal responsibilities. This article explores recent and documented breaches in infection control and discusses the financial impact of losing a license due to such situations.

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Dentistry is a demanding and rewarding profession. First, a dentist has spent years gaining the proficiency needed to graduate from dental school and obtain a license. Then, the provider devotes even more time and energy to building a successful practice. Patients develop confidence and faith in the dentist’s ability to establish and maintain their oral health and subsequently refer family and friends, leading to the practice’s growth and prosperity. Soon the community recognizes the dentist’s professionalism. As the practice thrives, so do the income levels derived from that practice, leading to a comfortable salary for the dentist.

However, some threats, if realized, could interrupt a dentist’s ability to practice. Injury or illness is a risk that everyone faces. Fortunately, disability insurance is available to somewhat obtund the financial impact. Unfortunately, suspension and/or revocation of a dental license through a state board action is another way a dentist can lose the ability to practice. Reasons that may cause a board to undertake these actions include fraud, sexual misconduct, criminal conviction, substance abuse and professional misconduct, negligence, and incompetence. Breaches of infection control fall into the latter two categories.

Lack of compliance with published infection-control guidelines can result in a significant risk for disease transmission and can compromise patient safety.1,2 In the past few years, several documented breaches of infection control have resulted in transmission of infectious diseases. In at least four states between 2012 and 2013, patients have been advised that they should receive testing for bloodborne infections (ie, HIV, hepatitis B [HBV], hepatitis C [HCV]) because of significant breaches of infection control at locations where they received dental care. In three of these cases, the dentist had a dental license suspended or revoked. Disability insurance or any compensation does not cover a dentist who has had a license suspended or revoked. The loss of income, as well as loss of professional credibility, can be considerable. What are the risks for transmitting an infectious disease in the dental office, and what is the cost of noncompliance? This article will discuss the emerging microbial threats confronting healthcare professionals in 2014, review some recent documented breaches of infection control in the dental office, and explain how it is much less expensive to adhere to recommended infection-control guidelines than shoulder the costs of noncompliance.

When Microbiology and Infection Control Are Ignored

The consequences of ignoring the principles of microbiology and infection control are well documented.3-5 Diseases are transmitted, people get sick, and some may die. The Centers for Disease Control and Prevention (CDC) estimates that in the United States, 1.7 million healthcare-associated infections (HAIs) occur each year, contributing to 99,000 deaths.3,4 Each year, HAIs kill more people than AIDS, breast cancer, and automobile accidents combined, and they have become the fourth leading cause of death in the United States.4,5

Despite the fact that highly resistant organisms that cause many HAIs are now common, studies show the compliance with infection control is often poor in certain cases of disease transmission, facilitating the spread of these infections.6-8 Data show that 5% to 10% of hospitalized patients in the developed world acquire such infections; the percentage is much higher in undeveloped countries.6,7 HAIs also occur in outpatient facilities, but because of the large number of these outpatient settings and the diversity in care delivered, the exact number of cases is difficult to determine. However, regardless of the healthcare setting, in many if not most of these cases, the HAI in question could have been prevented if recommended infection-control protocols had been followed.

For example, the proper use of hand hygiene is critical to the prevention of HAIs; however, compliance among healthcare workers is poor, usually below 40%.6,7 In a recent investigation, the hands of nearly one-quarter of healthcare workers were contaminated with Clostridium difficile spores after routine care of patients with this highly resistant pathogen; this hand contamination was positively associated with exposure to fecal soiling and lack of glove use and hand hygiene.8 With significant microbial threats facing society today, the situation is not likely to improve. The importance of infection control cannot be overstated.

Contaminated pharmaceuticals and unsafe injection practices have contributed to the number of HAIs. The CDC has received, and is still actively investigating, new reports of fungal infections among patients who were given injections of contaminated methylprednisolone acetate from the New England Compounding Center (NECC) in Framingham, Massachusetts. The CDC and US Food and Drug Administration have confirmed the presence of a fungus identified as Exserohilum rostratum in unopened medication vials of preservative-free methylprednisolone acetate from the NECC. These were injected into the joints and spines of patients who had injuries, arthritis, and other joint degeneration.9 Failure to eliminate contamination at the NECC resulted in an outbreak of 720 infections in 20 states, resulting in 48 deaths.9 As this investigation continues, more cases and deaths may be forthcoming.

Thirty-five outbreaks of viral hepatitis related to healthcare were reported to the CDC between 2008 and 2012.3 Almost all of these, 33 (94%) occurred in non-hospital settings; however, one outbreak took place at a free dental clinic in a school gymnasium and will be discussed in the section below.3,10 Many of these infections were transmitted by unsafe injection practices.3 Needles and/or syringes were reused, or a single-dose vial of a drug or a bag of intravenous fluids was used on more than one patient. In one instance, drug diversion (fentanyl) by an HCV-infected radiology technician transmitted HCV.3 These reports clearly document that when the principles of microbiology and infection control are not followed, diseases are transmitted. Most of these infections could have been prevented. Infection control is not optional; it is mandatory.

Documented Disease Transmission in the Dental Office

Most dentists adhere to the recommended principles of infection control. However, even with the best of practices, periodic lapses may occur.

In one report, molecular epidemiologic techniques documented the first patient-to-patient transmission of HBV in a dental office in the United States.11 In this case, two outpatient oral surgery patients received treatment 161 minutes apart.11 The index case was a 60-year-old woman with no typical risk factors for HBV.11 The reporting of her HBV infection to the health department triggered an investigation that found that a previous patient (patient No. 1) who had a hepatitis B e-antigen-positive status (HBeAg+; actively shedding and highly infectious for HBV) had been seen in the same dental office 161 minutes before the index case (patient No. 2).11 This launched a comprehensive investigation of the oral surgery practice. After an exhaustive review of the data, no other cases of HBV transmission from that dental office could be identified. The high rate of HBV vaccination among the other patients receiving treatment that day may have prevented other infections from occurring.

It was further noted that the dental office followed recommended infection-control protocols.11 All instruments were properly cleaned and sterilized; proper injection safety was followed; and no instruments used on patient No. 1 were used on patient No. 2.11 Although the transmission of HBV was confirmed, the mechanism of transmission could not be identified. However, cross-contamination was the suspected cause of this HBV transmission.11 HBV is the most transmissible of the bloodborne pathogens. Somewhere during the treatment of the HBeAg+ patient No. 1, a surface and/or instrument/device with the blood from patient No. 1 was allowed to come into contact with patient No. 2, transmitting HBV. This report’s conclusions clearly illustrate the importance of “meticulous maintenance of bloodborne pathogen infection control for all patients in dental settings.”11

HBV transmission in a dental setting was again documented in 2009. In this investigation, a cluster of acute HBV infections was reported among attendees of a 2-day portable dental clinic in Berkeley Springs, West Virginia.3,10 This report was recently described in detail and was the cover story in the October 2013 issue of The Journal of the American Dental Association.10 In a worthy effort to provide much needed dental care to impoverished persons, a charitable organization recruited 750 volunteers, including dental care providers, to provide oral health services in a local gymnasium.3,10 It was reported that 1,137 adults received care during that 2-day event, consisting mostly of extractions but other preventive and restorative procedures were performed.3,10

Unfortunately, five acute HBV infections involving three patients and two volunteers were identified by the local and state health departments.3,10 Subsequent investigation showed that three patients had extractions: one received restoration and one had a dental prophylaxis. According to the investigators, none receiving treatment shared a treatment provider.3,10 Of the volunteers, one worked in maintenance of the units/equipment, and the other directed patients from triage to the treatment waiting area.3,10 The exact mechanism of HBV transmission could not be identified, but breaches of infection control most likely resulted in these five transmissions of HBV.3,10 Dental care in portable/mobile dental settings can be safely performed when recommended infection-control protocols are instituted.12 To facilitate compliance in these settings, the Organization for Safety, Asepsis and Prevention (OSAP) has an excellent resource called, “Infection Control Checklist for Portable/Mobile Dental Clinics” (Table 1).12

While extremely rare, bloodborne pathogens can be transmitted in the dental setting and the two reports above reinforce the importance of meticulous infection control in dental settings. Most dentists do take infection control seriously and are compliant with recommended state and national guidelines that significantly reduce or eliminate the risks for disease transmission (Table 2). Unfortunately, a small minority does not follow recommended infection-control standards.

Cases have been documented showing that between 2012 and the present, patients have been put at significant risk for acquiring infectious diseases from dental practices in four states (Colorado, Oklahoma, Arkansas, Pennsylvania), and documented disease transmissions have occurred in at least one of these dental offices.13-19 Each of the cases described below describe the events that occurred, resulting in patients treated in these practices being advised by a state board and/or health department to get testing performed for HIV, HBV, and HCV. In three of these cases, the dentists’ licenses were suspended or revoked. Although these cases are a matter of public record, the names of the dentists have been omitted from this publication.

Unsafe Injections in Colorado

Responding to a complaint, the Colorado Department of Public Health and Environment began an investigation of an oral surgeon’s office.13 In July 2012, serious breaches of recommended safe injection practices were documented and patients were advised that they might have been put at risk for bloodborne infections.13

The health department advised patients that: “Between September 1999 and June 2011, syringes and needles were re-used for multiple patients to give intravenous (IV) medications, including sedation. The IV medications were given during oral and facial surgery procedures. Needles and syringes were used repeatedly, often for days at a time. Because there can be a small amount of blood that remains in syringes and needles after an injection through an IV line, there is a risk of spread of bloodborne viruses, such as HIV, hepatitis B, and hepatitis C, between patients. Due to the concern for the spread of HIV, hepatitis B, and hepatitis C, patients who received IV medications at this oral surgeon’s offices between September 1999 and June 2011 are advised to contact their health care provider to be tested for HIV, hepatitis B, and hepatitis C.”13

Reuse of syringes and needles is a flagrant violation of safe-injection practices and the principles of infection control. As a result of this investigation, this oral surgeon’s license to practice dentistry was revoked. Many patients who put their trust in this oral surgeon are now seeking damages and protracted lawsuits will continue for years.

Bloodborne Pathogen Exposure in Oklahoma

In March 2013 the Oklahoma Board of Dentistry initiated an investigation of an oral surgery practice after a patient with no other known risk factors tested positive for both HCV and HIV infections.14-16 The office was inspected, and based on the findings Oklahoma Health officials recommended on March 28, 2013 that more than 7,000 patients from an the Oklahoma City oral surgeon should receive testing for HIV, HBV, and HCV.14-16

Officials ordered this action because numerous and significant infection-control violations were found during the office inspection.14 It was documented that the dentist’s instruments were not being cleaned and/or sterilized properly.14 During the inspection, investigators found multiple sterilization issues, including cross-contamination of instruments and the use of a separate, rusty set of instruments for patients who were known to carry infectious diseases.14 Two sets of instruments were used, one for patients with known infectious disease (KD) and another for patients without known disease; each had a different cleaning method.14 The KD instruments were dipped in bleach in addition to other cleaning and were found to be pitted and rusted.14 According to the CDC, pitted, rusted, and porous instruments cannot be properly sterilized.14 Sterilization of any instruments used in the office was highly questionable because the autoclave had not been biologically monitored in 6 years.14 Use of single-vial dose medications on multiple patients was suspected, and the dentist allowed unlicensed individuals to perform procedures that would require licensure, such as administration of intravenous medications.14 Finally, the office had no written infection-control protocol.14

In September 2013, genetic-based testing of patient specimens by the CDC provided laboratory confirmation that patient-to-patient transmission of HCV occurred in the practice. This is the first documented report of patient-to-patient transmission of HCV associated with dentistry in the United States.16,17 Because of the magnitude of the infractions, this case received nationwide press coverage and the multiple breaches in the principles of infection control have resulted in revocation of this oral surgeon’s license to practice. As the investigation continues, more cases of bloodborne infections may be detected. The Oklahoma state epidemiologist assigned to this investigation stated: “While dental procedures are generally safe, this reinforces the importance of adhering to strict infection control procedures in dental settings.”16 Compliance with standard precautions and recommended sterilization practices could have prevented this.

Infectious Material Exposure in Arkansas

Based on information received from the Drug Enforcement Administration in April 2013, the Arkansas Department of Health (ADH) began contacting about 100 patients (ages ranging from 14 to 22 years) who received treatment from a Little Rock dentist at six dental clinics throughout the state between November 20, 2011 and February 20, 2012. ADH notified these patients that they may have been exposed to “infectious materials,” and advised them to receive testing for HIV, HBV, and HCV. 9 The dentist had a history of substance abuse, and ADH suspected that the dentist may have diverted some of the drugs for his own use, leading to contamination.18 The dentist has died; however, the cause of his death has not been released.18 No cases of disease transmission have been reported. This case is unusual because it could represent a deliberate contamination of IV drugs due to the dentist’s substance abuse.

Lack of Sterilization in Pennsylvania

On April 24, 2013 an unannounced inspection documented that a dentist in Springettsbury, Pennsylvania did not properly sterilize some devices used in patient treatment.19 Conse­quently, on April 29, 2013, Pennsylvania Department of Health, State Board of Dent­istry temporarily suspended the license of a general dentist, and the Pennsylvania Depart­ment of Health recommended HBV, HCV, and HIV testing for all current and former patients of this practice.19 In a letter to the patients in this practice, the Pennsylvania Department of Health announced:

“The Pennsylvania Department of Health (DOH) is advising all current and former patients of a York County dentist they might be at risk for infection after an investigation discovered the dental facility did not follow appropriate infection control procedures.

To date, the investigation has found the dentist did not properly clean, disinfect or sterilize devices at her dental office.

The departments of Health and State conducted a joint, unannounced site visit of this dental practice on April 24. The Pennsylvania State Board of Dentistry temporarily suspended the dentist’s dental license on April 29.

Currently, DOH has not received any related reports of diseases or illnesses being spread to or among patients of this dentist. Out of an abundance of caution—and to ensure the wellbeing of the public—DOH is recommending current or former patients of this dentist get tested for hepatitis B, hepatitis C and human immunodeficiency virus (HIV).

Additional information regarding this investigation can be found by clicking on the tabs below. DOH will continue to update this webpage with important information and keep the public informed as this investigation continues.”19

To date, no disease transmission has been detected in this investigation and after remediation of the infection-control violations, the dental license could be reinstated. However, patients have been subjected to a great deal of anxiety, and the reputation of this dentist has been severely compromised. Proper cleaning, disinfection, and sterilization of devices used during patient care could have prevented this action by the state of Pennsylvania.

The Cost of Noncompliance

Infection control is not optional. Dental practitioners have moral, legal, and ethical responsibilities to deliver oral healthcare as safely as possible. Most dentists do follow recommended infection-control guidelines. Patient safety must be paramount.

The cost of noncompliance is difficult to calculate. According to the American Dental Association, in 2011, the net income for a general dentist was $192,392 and $313,873 for a specialist.20 All that income is terminated when a license is revoked. If a license is suspended, a dental board will usually suspend the license until that dentist has documented that the infection-control violations have been remediated and it is safe to resume patient treatment. This timeframe is variable, depending on the degree of remediation and the willingness of the dentist to modify his or her behavior and pay for additional equipment/devices needed to safely treat patients.

Representation by an attorney is almost mandatory in response to any board action. The average attorney charges at least $350 an hour with a $5,000 retainer fee; at least 10 to 20 billable hours may be needed. In most cases, an infection-control consultant must be hired to provide the remediation and provide periodic reassessment reports to the board for a certain period, usually 1 to 2 years. A rough estimate of the cost of noncompliance is presented in Table 3. This is just meant to be an approximation of the anticipated costs, which could greatly exceed this calculation. Based on this estimate, a 3-month suspension of a license will cost a general dentist between $54,000 and $60,000 in lost income and estimated attorney/consultant fees and a 6-month suspension will cost $84,500 to $90,500; a specialist’s costs will be $102,000 to $108,000 for 3 months and $163,000 to $169,000 for 6 months.

Until the suspension is lifted, the dentist cannot practice, but the usual expenses (eg, rent, leasing fees, payroll, insurance, phone, utilities) continue, adding to the financial deficit. The loss of patient trust is incalculable. It often takes years to establish a successful dental practice. However, once the trust between patients and a dental practice has been broken it may take years to reestablish that practice, if it can be reestablished at all. Sadly, the cost of compliance is a fraction of the cost of noncompliance.

Conclusion

The cost of noncompliance is significant both professionally and financially for the dentist and can result in serious and life-threatening disease transmission in the patients receiving treatment in that dental practice. Infection control is not optional. Dentists have moral, ethical, and legal responsibilities to provide oral healthcare as safely as possible. Dental practitioners need to be involved and actively monitor that everyone on the dental team is compliant with all of the principles of infection control.

References

1. Kohn WG, Collins AS, Cleveland JL, et al. Guidelines for infection control in dental health-care settings guidelines for infection control in dental health-care settings—2003. 2003;52(RR17);1-61.

2. Centers for Disease Control and Prevention. Guide to infection prevention for outpatient settings: minimum expectations for safe care. Published May 11, 2011. www.cdc.gov/HAI/pdfs/guidelines/standatds-of-ambulatory-care-7-2011.pdf. Accessed April 3 2014.

3. Viral hepatitis outbreaks. Healthcare-associated hepatitis B and C outbreaks reported to the Centers for Disease Control and Prevention (CDC) in 2008-2012. Centers for Disease Control and Prevention website. Updated May 21, 2013. www.cdc.gov/hepatitis/outbreaks/healthcarehepoutbreaktable.htm. Accessed April 3, 2014.

4. Klevens RM, Edwards JR, Horan TC, et al. Esti­mating health care-associated infections and deaths in U.S. hospitals, 2002. Public Health Rep. 2007;122
(2):160-166.

5. Scott RD II; Division of Healthcare Quality Promotion, National Center for Preparedness, Detection, and Control of Infectious Diseases, Coordinating Center for Infectious Diseases, Centers for Disease Control and Prevention. The direct medical costs of healthcare-associated infections in U.S. hospitals and the benefits of prevention. Published March 2009. www.cdc.gov/hai/pdfs/hai/scott_costpaper.pdf. Accessed April 3, 2014.

6. World Health Organization. WHO guidelines on hand hygiene in health care. World Health Organization Web site. Published 2009. http://whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf. Accessed April 3, 2014.

7. Longtin Y, Sax H, Allegranzi B, Schneider F, Pittet D. Videos in clinical medicine: hand hygiene N Engl J Med. 2011;364(13):e24.

8. Landelle C, Verachten M, Legrand P, et al. Contamination of healthcare workers’ hands with Clostridium difficile spores after caring for patients with C. difficile infection, Infect Control Hosp Epidemiol. 2014;35(1):10-15

9. Centers for Disease Control and Prevention Web site. Notice to clinicians: continued vigilance urged for fungal infections among patients who received contaminated steroid injections. Updated March 4, 2013. http://emergency.cdc.gov/HAN/han00342.asp. Accessed April 3, 2014.

10. Radcliffe RA, Bixler D, Moorman A, et al. Hepatitis B virus transmissions associated with a portable dental clinic, West Virginia, 2009, J Am Dent Assoc., 2013;144(10):1110-1118.

11. Redd JT, Baumbach J, Kohn W, et al. Patient-to-patient transmission of hepatitis B virus associated with oral surgery. J Infect Dis. 2007;195(9):1311-1314.

12. Infection control checklist for dental settings using mobile vans or portable dental equipment. Organization for Safety, Asepsis and Prevention Web site. http://c.ymcdn.com/sites/www.osap.org/resource/resmgr/Checklists/OSAP.checklist.portabledenta.pdf. Accessed April 3, 2014.

13. Unsafe injections at an oral surgeon’s offices. Frequently asked questions. Colorado Department of Public Health and Environment website. Updated July 20, 2012. www.colorado.gov/cs/Satellite?blobcol=urldata&blobheadername1=Content-Disposition&blobheadername2=Content-Type&blobheadervalue1=inline%3B+filename%3D%22Frequently
+Asked+Questions.pdf%22&blobheadervalue2=application%2Fpdf&blobkey=id&blobtable=MungoBlobs&blobwhere=1251816616499&ssbinary=true
. Accessed April 3, 2014.

14. Oklahoma Board of Dentistry. Oklahoma government website. Statement of complaint against Wayne Scott Harrington, DMD, Case No: 13-005. March 28, 2013. www.ok.gov/dentistry/documents/harrington%20official%20complaint.pdf. Accessed April 3, 2014.

15. Tulsa Health Department Web site. Public health response: situation update 22. www.tulsa-health.org/news/public-health-response-situation-update-22#.Uz2G4sduo1I. Accessed April 3, 2014.

16. Health officials announce new results of Harrington investigation [news release]. Tulsa, OK: Tulsa Health Department; October 17, 2013. www.ok.gov/health/Organization/Office_of_Communications/News_Releases/2013_News_Releases/Public_Health_Investigation_of_Tulsa_Dental_Practice.html. Accessed April 3, 2014.

17. American Dental Association statement on infection control in dental settings. American Dental Association website. Published September 19, 2013. www.ada.org/9058.aspx. Accessed April 3, 2014.

18. Nuss J, Officials urge Arkansas dentist’s patients to get tested. Associated Press. April 10, 2013.

www.cnn.com/2013/04/10/us/arkansas-dentist-investigation. Accessed April 3, 2014.

19. Department of Health investigating York County dentist. Pennsylvania Department of Health Web site. June 4, 2013. www.portal.state.pa.us/portal/server.pt?open=514&objID=1525641&mode=2. Accessed April 3, 2014.

20. Vujicic M, Wall TP, Nasseh K, Munson B; American Dental Association. Health Policy Resources Center research brief. Dentist income levels slow to recover. February 2013. www.ada.org/sections/professionalResources/pdfs/HPRCBrief_0213_1.pdf. Accessed April 3, 2014.

About the Author

Louis G. DePaola, DDS, MS
Assistant Dean of Clinical Affairs
Professor
Department of Oncology & Diagnostic Sciences
University of Maryland School of Dentistry
Baltimore, Maryland

Table 1

Table 2

Table 3

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  • • Discuss recent situations in which significant breaches of infection control lead to disease transmission.
  • • Identify the possible financial impact of short-term loss of licensure.