Toronto Public Health HCV Outbreak Investigation Ontario Endoscopy Clinic 1315 Finch Avenue West, Suite 302, Toronto Final Report April 24, 2015

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1 Toronto Public Health HCV Outbreak Investigation Ontario Endoscopy Clinic 1315 Finch Avenue West, Suite 302, Toronto Final Report April 24, 2015 Initial Case Identification On May 24, 2013, a 60 year old female Case 1 (index) was reported to Toronto Public Health (TPH) as Hepatitis C Virus (HCV) antibody positive. Risk factors as per the TPH physician HCV report form and/or TPH client interview included a skin tag removal at a physician's office on November 30, 2012, a colonoscopy at the Ontario Endoscopy Clinic (OEC) on March 15, 2013 and a history of a tattoo 18 years previously. No other risk factors such as sexual contact with a HCV-carrier or injection drug use were noted. Case had symptom onset of nausea and anorexia in late April 2013; fatigue May 1, 2013; dark urine May 6, 2013; Jaundice May 9, Liver function tests (LFTs) were elevated on May 13, 2013 with ST 1082, ALT 829 and total bilirubin 223. Case 1 had no previous HCV test results on file. Given the onset of symptoms in late April 2013, and the incubation period for HCV of two weeks to six months, the HCV infection was likely acquired between late October 2012 and April The skin tag removal and the colonoscopy fall within this window period and were therefore the focus of TPH's investigation. Source Identification On July 15, 2013 TPH contacted the physician's office where the skin tag removal was performed and requested a list of all patients seen 4 days before and 4 days after November 30, Determination of this time frame was based on estimated time of survival of the HCV and the usual time period that multi-dose medication containers are in use in these settings. 1 The office provided lists for November 27, 29, 30, and December 4, 2012 as no procedures were performed on the other dates. This list was forwarded to Public Health Ontario (PHO) to be matched with records of all cases of HCV and HBV reported to local public health units in Ontario using the Integrated Public Health Information System (iphis). No other HCV positive patients were identified. No HCV positive test result was found on file for the physician, who was the only health care provider involved in the procedures. Toronto Public Health contacted the OEC on July 15, 2013 and requested a list of patients who had endoscopy procedures at the clinic from March 11 to March 19, 2013, 4 days before and 4 days after March 15, Lists were provided for March 11, 14, 15, 16, 18 and 19 as the clinic was closed on the other dates. On November 8, 2013 TPH requested a list of clinic staff who worked on those dates. Ontario Endoscopy Clinic Final Report (April 24, 2015) Page 1 of 13

2 Public Health Ontario (PHO) matched patient and staff lists with records of all HCV/HBV cases reported to local public health units in Ontario using iphis. The matching process identified a potential source patient Case 2 who was known to be HCV positive on January 10, 2003 and whose endoscopy procedure on March 15, 2013 took place prior to that of the Case 1 (index) (Table 1). Cases 1 and 2 are both infected with HCV genotype 1b. Samples of blood from Case 1 and Case 2 were sent by PHO to the National Microbiology Laboratory (NML) in Winnipeg in order for sequencing to be performed on the viruses. Expert opinion from the NML microbiologist received on November 7, 2013 indicated that the viruses from these patients are genetically highly related, indicative of possible transmission (Appendices 1a and 1b). Consultation with an infectious diseases specialist also confirmed that Case 2's HCV-RNA level was sufficient (1.19E+7 IU/mL on May 28, 2013) to be the source of HCV for Case 1 (Personal Communication Dr. Tony Mazzulli). Case Finding On October 2, 2013, PHO notified TPH of two additional cases of HCV, Case 3 and Case 4, both of whom had endoscopy at OEC on March 15, Case 3 and Case 4 reside in neighbouring health units. On November 8, 2013 TPH created "OEC" as an "Exposure" for HCV in iphis where all reported diseases in Ontario, including HCV, are recorded. This allows public health investigators to search OEC as a potential exposure site for a client's HCV infection. As of January 31, 2014, TPH placed electronic "flags" in iphis on the files of all non- Toronto residents who underwent endoscopies at OEC between March 15-19, With this flag in place, if an Ontario health unit received a report of HCV in any patient who received a procedure at OEC between March 15-19, 2013 the flag would indicate to the public health investigator that this client was part of a TPH investigation. On January 17, 2014, TPH sent letters to patients who had a procedure at OEC between March 15 and 19, 2013 and to all staff and physicians who worked on those dates, recommending testing for HCV and HBV. Patients who had procedures on March 15, 2013 received a follow up telephone call to recommend testing if they did not go for testing upon receipt of the letter (Appendix 2). Case 5 is a resident of a neighboring health unit, who had an endoscopy at OEC on March 15, 2013, and who was identified as HCV positive to TPH in January 28, Case 5 is a blood donor who was regularly tested by Canadian Blood Services (CBS) and who converted to HCV positive on October 11, Case 5 had a previous negative result for HCV on October 19, Ontario Endoscopy Clinic Final Report (April 24, 2015) Page 2 of 13

3 As a result of the TPH letters and phone calls to OEC patients with procedures on March 15, 2013, Case 6 was reported to TPH on February 5, Case 6 had symptom onset in June, Three of these four additional HCV positive cases (Case 3, Case 4, Case 6) were found to be HCV genotype 1b, the same as that of the source patient Case 2. Case 5 did not have any RNA present so was unable to be subtyped. The blood samples of these three additional cases were forwarded to the NML and on March 24, 2014 the NML microbiologist indicated that the viruses from these patients are genetically highly related, indicative of possible transmission (Table 1 and Appendices 1a and 1b). Ten of the twenty staff/physicians, including the anaesthesiologist who worked on March 15, 2013, were tested and were found to be HCV negative (Appendix 2). Infection Prevention and Control (IPAC) Investigation Reports from the College of Physicians and Surgeons of Ontario (CPSO) Out of Hospital (OOH) Inspection Program were reviewed. The CPSO's Premises Inspection Committee Decision Letter dated January 6, 2011 indicated that OEC received a pass through the OOH program, and no infection control issues were noted. IPAC investigation was accomplished through direct observation, interview, chart review, review of purchasing records and review of clinic policies and procedures. The findings from these components of the investigation were placed into context through a review of the relevant literature and consultation with experts in this area. 2,3,4,5 On July 25, 2013 the manager and communicable disease investigator (CDI), in the TPH Control of Infectious Diseases and Infection Control (CIDIC) program attended the physician's office where the skin tag removal was performed and conducted an IPAC audit. The audit revealed no significant issues other than the sterilizer was not routinely tested with a biological indicator (BI). TPH recommended that the gynecologist use only pre-sterilized single use devices until the sterilizer met the required three passes of a BI, which was completed September 25, On August 16, 2013 the TPH manager and communicable disease investigator attended OEC and conducted IPAC Canada audits on general office infection prevention and control, reprocessing of endoscopes and injection safety. The CHICA- Canada (now known as IPAC Canada) Infection Prevention and Control Audit for Endoscopy was used. No critical items were found to be in breach at the time of the audit. During the visit the infection control practices of the endoscopist and anesthesiologist working that day were observed. The clinic's IPAC and staff training policies and procedures were reviewed. Environmental cleaning and reprocessing procedures were reviewed and observed, including the observation and review of the use of the Automated Endoscope Reprocessor (AER). Additionally, the storage, preparation, and use of medication was observed and reviewed. Ontario Endoscopy Clinic Final Report (April 24, 2015) Page 3 of 13

4 The following recommendations were made based on the visits and IPAC audits of OEC: Ensure point of use placement of alcohol based handrubs (ABHRs) when there is no dedicated handwash sink available in the room. For example, ABHRs should be situated in the reprocessing room, and on both side of the procedure rooms. Ensure there are written IPAC procedures for use of Single Use Medical Devices (SUDs) Staff should be trained at a minimum once per year on IPAC routine practices, and document the training. Ensure the anaesthesia and nursing preparation and procedure areas only contain vials and/or equipment required for immediate patient care. All other vials/equipment not being used should be removed from the area. Ensure that if an item has been removed from the packaging or moved from a sterile area to a procedure area, it is not to be put back into the clean/sterile area until the item has been reprocessed. Ensure equipment is clearly labelled as clean or dirty in all areas of the clinic. Safety Engineered Needles (SENs) should be used for all injection procedures. On October 4, 2013 the TPH manager and communicable disease investigator observed the practice of the endoscopist who worked on March 15, 2013 and his practices were found to be satisfactory regarding infection control. Medication Administration: Investigation The anaesthesiologist's practice regarding medication administration was determined by TPH through direct observation, interview of anaesthesiologist and nurse and review of anaesthetic and purchasing records. The time delay between the procedure date in question and the interviews likely affected recall of details. On August 16, 2013 the TPH manager and communicable disease investigator observed the practice of the anaesthesiologist. On January 27, 2014 a TPH Associate Medical Officer of Health, and TPH CID/IC Manager interviewed the anaesthesiologist. The TPH AMOH re-interviewed the anaesthesiologist on June 23, 2014 (by phone). Interviews of the anaesthesiologist gathered detailed information on the following: types of medications used vial sizes for each medication syringe sizes and amounts of medication drawn into each syringe placement of unused filled syringes in the procedure room method of medication administration method of administration of additional doses of medication if required during procedure placement and disposal of used syringes and needles in the procedure room disposal of opened medication vials Ontario Endoscopy Clinic Final Report (April 24, 2015) Page 4 of 13

5 Purchasing records for medications and syringes provided additional information on vial and syringe sizes. Review of the anaesthetic record for each patient provided information on types and amounts of medication used during each procedure and how it was administered. Discussion The TPH investigation has shown that five patients acquired HCV during their endoscopic procedure at OEC on March 15, 2013 (Table 1). A source patient Case 2 known to be infected with HCV had a procedure at the OEC prior to the five newly infected patients' procedures. The HCV of the source patient Case 2 and those of four of the five newly infected patients - Case 1 (the index), Case 3, Case 4 and Case 6 have been demonstrated via sequencing testing at the NML to be essentially the same virus (Appendices 1a and 1b). One patient, Case 5, did not have virus present at the time of identification by TPH, therefore sequencing was not possible. However, as previously stated, Case 5 was a regular blood donor and previous tests negative for HCV are on file with the most recent negative being on October 19, The source patient Case 2 was patient # 4 of the day, and was given an additional dose of medication during his procedure. The other cases were patient #s 5, 6, 7, 8, and 10 of the day. A total of 10 patients had procedures in the same procedure room with the same endoscopist and anaesthesiologist. In other words, all except one of the patients who had a procedure following Case 2 on March 15, 2013, acquired HCV. Patients who had procedures on March 16 and , and who went for testing, were negative for HCV (Appendix 2). Theoretically, contamination of the endoscopes can result in HCV transmission. In this case, a different endoscope was used on each of the 6 patients (source and five others). Patient # 9, who is HCV negative, had endoscopy with the same number endoscope as the source patient. Scopes are reprocessed and circulated to either of the two rooms that were in use on March 15, Of the patients who had procedures in the second endoscopy room, with a different endoscopist and a different anaesthesiologist (and who were tested), none were found to be HCV positive (Table 2). Biopsy equipment was single use disposable in all instances when a biopsy was taken. The reprocessing of the endoscopes was conducted by a trained technician and no critical IPAC breaches were identified. Thus this hypothesis seems unlikely. The literature supports 2,3,4 the theory that HCV transmission occurs in health care settings as a result of mishandling of multi-dose injectable medications. The use of these multi-dose injectables, while common, presents greater risk when used in a high volume, rapid turnover environment. Ontario Endoscopy Clinic Final Report (April 24, 2015) Page 5 of 13

6 It is possible that one of the medication vials became contaminated with blood from Case 2, as all except one of the 6 subsequent patients became infected with HCV. The largest size propofol vial would not have provided enough doses for all the patient procedures subsequent to the source patient. The lidocaine from one vial could have been used for all the patient procedures on that day in that procedure room. It is likely the lidocaine vial became contaminated with blood from the source. If the lidocaine bottles are discarded at the end of the day as described by the clinic staff, that would explain why the patients who had procedures at OEC on March 16, 2013 were not infected (Table 3). Conclusion Five patients became infected with HCV during their procedures at the OEC on March 15, Genetic sequencing shows that the HCV of four of the five patients and the HCV of a previously infected patient who had a procedure earlier in the day are genetically highly related. The fifth patient had a documented previous negative result for HCV. It is possible that a vial of medication, most likely lidocaine, became contaminated. TPH has notified the five patients who became infected with HCV during their procedure(s) on March 15, 2013 at the OEC of this outbreak. Information on the risk of exposure to HCV and HBV was also provided to patients seen the same day as these five patients and those seen on March 16, 18 and 19, 2013, along with recommendations for testing. No additional newly HCV-infected individuals were found. In addition, TPH conducted a look-back of patients who had a procedure at the OEC in the five years prior to the date of transmission (March 15, 2013) and were cared for by the anaesthesiologist who worked on that day; these patients' names were submitted to PHO to compare with all records of reported HCV or HBV cases in Ontario. Additional testing was recommended for patients who had a procedure on a single date (June 27, 2008). No additional newly HCV-infected or HBV-infected individuals were found. TPH has worked with the clinic owner and made recommendations regarding IPAC issues. In addition, TPH has made the College of Physicians and Surgeons of Ontario, the Ontario Ministry of Health & Long-Term Care and Public Health Ontario aware of this outbreak. Ontario Endoscopy Clinic Final Report (April 24, 2015) Page 6 of 13

7 References 1) Infectivity of Hepatitis C Virus in Plasma After Drying and Storing at Room Temperature. Infection Control and Hospital Epidemiology, vol. 28(5), May 2007, pp ) Investigation of Viral Hepatitis Infections Possibly Associated with Health-Care Delivery New York City, Morbidity and Mortality Weekly Report, vol. 61(19), May 12 th, ) Acute Hepatitis C Virus Infections Attributed to Unsafe Injection Practices at an Endoscopy Clinic Nevada, Morbidity and Mortality Weekly Report, vol. 57(19), May 16 th, ) Multiple Clusters of Hepatitis Virus Infections Associated With Anesthesia for Outpatient Endoscopy Procedures. Gastroenterology, vol. 139, 2010, pp ) Personal Telephone and Electronic Communication with Anil Suryaprasad & Melissa Schaefer, CDC, Atlanta, USA, April 29, 2013 and June 20 & 24, Ontario Endoscopy Clinic Final Report (April 24, 2015) Page 7 of 13

8 Table 1 - OEC (HCV2) Patients who underwent Endoscopies at Ontario Endoscopy Clinic Finch Location on March 15, 2013, room 1 Patient # of the day Endoscopist Anaesthesiologist Case # HCV Status Procedure Scope # Biopsy (y/n) Medication doses 1 Dr. CC Dr. XX n/a HCV - Colonoscopy N Propofol: Dr. CC Dr. XX n/a HCV Colonoscopy N Propofol: Dr. CC Dr. XX n/a HCV Colonoscopy N Propofol: Dr. CC Dr. XX 2** HCV+ Colonoscopy N Propofol: Source Related 5 Dr. CC Dr. XX 3 HCV+ Colonoscopy N Propofol: 150 Related 6 Dr. CC Dr. XX 1* HCV+ Colonoscopy N Propofol: 150 Index Related 7 Dr. CC Dr. XX 6 HCV+ Colonoscopy Y Propofol: Related 8 Dr. CC Dr. XX 4 HCV+ Double Y Propofol: Related 9 Dr. CC Dr. XX n/a HCV - Colonoscopy N Propofol: Dr. CC Dr. XX 5 HCV+ No RNA Gastroscopy Y Propofol: 200 * Index case ** Source case Note: Lidocaine doses were not recorded Ontario Endoscopy Clinic Final Report (April 24, 2015) Page 8 of 13

9 Table 2 - OEC (HCV2) Patients who underwent Endoscopies at Ontario Endoscopy Clinic Finch Location on March 15, nd room (other Endoscopist and Anaesthesiologist) Patient # of the day Endoscopist Anaesthesiologist Case # HCV Status (date) Procedure Scope # Biopsy (y/n) Medication doses 1 Dr. DD Dr. WW n/a Lost to Gastroscopy Y Propofol: 140 Follow-up 2 Dr. DD Dr. WW n/a Negative Gastroscopy Y Propofol: Dr. DD Dr. WW n/a Negative Double Y Propofol: Dr. DD Dr. WW n/a Negative Colonoscopy Y Propofol: Dr. DD Dr. WW n/a Negative Gastroscopy N Propofol: Dr. DD Dr. WW n/a Negative Colonoscopy Y Propofol: Dr. DD Dr. WW n/a Negative Gastroscopy Y Propofol: Dr. DD Dr. WW n/a Negative Colonoscopy Propofol: Dr. DD Dr. WW n/a Negative Double Y Propofol: 10 Dr. DD Dr. WW n/a Negative Colonoscopy N Propofol: Dr. DD Dr. WW n/a Negative Double Y Propofol: Dr. DD Dr. WW n/a Negative Flexible Propofol: 140 Sigmoidoscopy 13 Dr. DD Dr. WW n/a Negative Colonoscopy Y Propofol: Dr. DD Dr. WW n/a Negative Gastroscopy Y Propofol: 150 Note: Lidocaine doses were not recorded Not able to read dose amount Was unclear in clinic's patient chart if biopsy was performed Ontario Endoscopy Clinic Final Report (April 24, 2015) Page 9 of 13

10 Table 3 Summary of patients seen at OEC March 16, 2013 Patient # of the day HCV Status/ date (-ve = negative) Endoscopist Anaesthesiologist Procedure Scope # Medication doses 1 HCV -ve Dr. EE Dr. ZZ Gastroscopy + colonoscopy HCV -ve Dr. EE Dr. ZZ Gastroscopy colonoscopy 3 LTFU (not able Dr. EE Dr. ZZ Gastroscopy to reach) colonoscopy 4 Unknown Dr. EE Dr. ZZ Colonoscopy Unknown Dr. EE Dr. ZZ Gastroscopy Unknown Dr. EE Dr. ZZ Gastroscopy HCV -ve Dr. EE Dr. ZZ Colonoscopy Unknown Dr. EE Dr. ZZ Gastroscopy HCV -ve Dr. EE Dr. ZZ Gastroscopy Unknown Dr. EE Dr. ZZ Colonoscopy Unknown Dr. EE Dr. ZZ Colonoscopy HCV -ve Dr. EE Dr. ZZ Colonoscopy Unknown Dr. EE Dr. ZZ Gastroscopy Missing 14 Unknown Dr. EE Dr. ZZ Gastroscopy Missing Not recorded by TPH Two rooms were in use on March 16, 2013 with only one endoscopist and only one anaesthesiologist for both rooms. Ontario Endoscopy Clinic Final Report (April 24, 2015) Page 10 of 13

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13 Appendix 2 Follow-up and Testing Patients and Staff - Ontario Endoscopy Clinic Patients Procedure date Number of people Identified HCV+ Identified HCV+ Contacted by TPH/TPH received call Tested (%)** (iphis) (letter) Called by TPH Sent a letter Called TPH after letter High risk 15-Mar-13 23* 4* (95.7%) Low risk 16-Mar (53.8%) 18-Mar (63.6%) 19-Mar (44.4%) Total (71.4%) Staff Mar (50.0%) *Index and source case are included. **Testing status is unknown for 26 individuals. Ontario Endoscopy Clinic Final Report (April 24, 2015) Page 13 of 13