Article
In October 2015, the New Jersey Department of Health (NJDOH) indicated that it had received reports of three patients who developed Enterococcus faecalis endocarditis after undergoing surgical procedures at the same oral surgery practice. The NJDOH immediately conducted retroactive surveillance to identify other possible cases. Departmental public health specialists inspected the practice, interviewed staff members and reviewed medical records.1
To identify additional patients with bacterial endocarditis, appointment records initially were reviewed for 2013−2014. Later, this was extended through to mid-2016. Patients listed were compared to discharge records from state inpatient hospitalizations and emergency department visits. Patients with diagnostic billing codes for endocarditis or enterococcal infection were selected.
A confirmed case was a patient of the practice who received a diagnosis of infective endocarditis and a documented E. faecalis bacteremia within 6 months after an oral surgery procedure. All confirmed cases were interviewed and their clinical course reviewed, which included all possible sources of enteroccocal infection. The number of oral surgery visits, types of procedures performed and medications administered were determined for the matched patients. Officials then sent email notifications to all New Jersey healthcare providers asking them to report any cases of endocarditis or enterococcal infection.
The NJDOH also conducted two unannounced office inspections and environmental assessments, which included medication and supply storage, medication preparation, interviews of staff members concerning infection prevention practices, compliance documents, medical records and medical waste management procedures. During the first visit, the review team observed patient procedures and infection prevention practices. The second visit included observation of infection prevention practices by staff members conducting mock procedures.
Surveillance confirmed an additional 12 confirmed patients with E. faecalis endocarditis for a total of 15 patients. All had undergone oral surgery procedures which involved the use of IV sedation. The median age at the time of treatment was 46 years with 11 (73%) under the age of 60. The period between treatment and the first positive E. faecalis blood culture averaged 87 days. Four patients had underlying medical conditions that could increase their chances of developing bacterial endocarditis. However, none of the 15 patients had a cardiac condition that required antimicrobial prophylaxis or had an illness that placed him/her at increased risk for infection. Azithromycin was prescribed for 13 patients post-operatively. No patient that was treated using only local anesthetics developed endocarditis.
Of the 15 confirmed cases, 12 underwent cardiac surgery because of their infection. Eight had valves replaced and the other four had valve debridement and repair. One patient (under 60 with no underlying conditions) died of complications of endocarditis and associated cardiac surgery. The expected annual incidence of E. faecalis endocarditis should be less than 1.5 patients per 100,000. However, during 2013−2014, patients of the oral surgery practice experienced an incidence 200 times the expected rate.
One oral surgeon performed all procedures with at least one dental assistant being present and included local anesthetics, inhaled nitrous oxide and IV sedation. On average, 21 appointments were scheduled each day.
The initial unannounced inspection identified 10 breaches of infection prevention practices as recommended by the Centers for Disease Control and Prevention.2,3 These were be divided into five categories (Table 1).
| Category | Select Findings |
|---|---|
| Failure to develop a Written Control Plan | Staff members not trained on infection prevention and instrument reprocessing |
| Improper handling/storage of medications | Single dose vials routinely used for more than 1 patient, including propofol |
| Failure to maintain sterility of products and instruments, aseptic techniques and a safe environment | Syringes with needles attached and IV catheters removed from sterile packages and stored in the open and in drawers well in advance of procedures |
| Failure to monitor cleaning, disinfection and sterilization processes | Inadequately trained staff |
| Failure to use appropriate PPE and other protective devices | Staff only wore scrubs with exposed arms (no gowns) |
During the initial inspection, the findings were presented orally and then later, in writing. The review team recommended that the practice immediately hire an infection preventionist and review staff competencies. An external consultant was hired to conduct the second unannounced site visit. The practice had made some procedural and equipment changes; however, significant deficiencies remained and were shared verbally and later in writing.
The New Jersey Department of Dentistry suspended the oral surgeon's license in August 2016 after a third inspection indicated continuing infection prevention problems. A formal appeal hearing is pending.
An outbreak of enterococcal endocarditis involving treatment given by one oral surgeon in a single clinic remained undetected for more than 20 months. A physician, after treating two of the affected patients, determined a common link and made a report to the NJDOH. An investigation indicated that 15 patients developed E. faecalis endocarditis, most likely involving breaches in infection prevention practices associated with IV sedation. The outbreak reinforces two salient points: