Toronto Public Health HCV Outbreak Investigation Downsview Endoscopy Clinic 968 Wilson Avenue, Toronto Final Report October 6, 2014

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1 Toronto Public Health HCV Outbreak Investigation Downsview Endoscopy Clinic 968 Wilson Avenue, Toronto Final Report October 6, 2014 Initial Case Identification On June 6, 2013, a 58 year old male (Case 1) was reported to Toronto Public Health (TPH) as Hepatitis C virus (HCV) antibody and antigen positive (blood test collected May 30, 2013). HCV risk factors indicated on the TPH physician HCV report form and/or TPH client interview included a number of medical procedures between 2005 and 2012 and travel to an area with moderate HCV population prevalence (prevalence of 1.5% to 3.5%(8)) twice. Case 1 was a known Hepatitis B virus (HBV) carrier who immigrated to Canada in 1997 from Romania. No other risk factors such as sexual contact with a HCV-carrier, injection drug use or receipt of a tattoo were noted. During medical work-up for a long history of abdominal signs and symptoms (nausea, vomiting, anorexia and changes in stool colour) he tested negative for HCV on January 23, Between January and September 2012, Case 1 had elevated liver function tests (LFTs) which peaked in early April (ALT=365, AST=185). He was referred to a hepatologist (consult note to family doctor May 14, 2012) who began a work-up for autoimmune hepatitis including planning for a liver biopsy. Once it was determined that this patient had seroconverted from HCV negative to HCV positive sometime between January 23, 2012 and May 30, 2013 (confirmation of January 23, 2012 negative HCV test received by TPH August 20, 2013), an investigation was initiated. The investigation focused on risk factors in the last six months of 2011, assuming an incubation period for HCV of two weeks to six months and assuming that the elevated LFTs seen in 2012 were possibly related to acute HCV infection. The esophagogastroduodenoscopy/ colonoscopy on December 7, 2011, at the Downsview Endoscopy Clinic (DEC) was the initial focus of the investigation because those procedures fell within this window and even after repeated interviews, no other risk factors during this period were found. Source Identification/Case Finding A list of patients seen on December 5, 6, and 7, 2011 at the DEC was requested by letter on September 25, 2013 to determine if a known HCV-infected individual was seen prior to Case 1's procedures. Staff names and home addresses for those who worked during these three days were also requested. Patients seen and staff who worked in the two days before Case 1's procedures were requested because previous healthcare-associated HCV outbreaks have been caused by contaminated multi-dose medication vials (1) (2) (3) which are usually used up within two days of opening. Public Health Ontario matched the patient and staff lists with records of all HCV cases reported to Ontario local public health departments. This found that on December 7, 2011, the day when Downsview Endoscopy Clinic HCV Outbreak Final Report (October 6, 2014) 1

2 Case 1 underwent his procedures, four other known HCV-positive patients were seen at the DEC (Cases 2, 3, 4 and 5). Cases 2 and 5 were reported to local public health as HCV positive well before the date of their procedure at the DEC. Cases 3 and 4 were reported as HCV positive after their procedures at the DEC (see Table 1). No HCV positive staff were identified in the Public Health Ontario records. Also, the DEC was put into the integrated Public Health Information System (iphis) as a HCV "exposure" site. Any subsequent HCV cases that were identified and investigated in Ontario could potentially be linked with this exposure if it was identified during the investigation as a location visited by a HCV case before they tested positive for HCV. At the time of this report, no further HCV cases were linked to this exposure setting in iphis. Neither Case 3 nor 4 had a previous HCV test that they could recall, making it impossible to definitively conclude that they were recently infected. Risk factor information indicated that Case 3 had an invasive procedure in Ontario in 1984 but otherwise had no HCV risk factors and was asymptomatic when tested due to increasing LFTs. Case 3 remains chronically infected with HCV. Case 4 had a previous tattoo but otherwise had no HCV risk factors and presented with HCV signs and symptoms (jaundice, itchiness and increased LFTs) between January and February 2012 and was tested on February 6, Case 4 was successfully treated in 2012, and was HCV RNA negative when the investigation was initiated. However, subsequent HCV testing requested as part of the investigation showed that Case 4 was once again HCV-RNA positive. To compare the type of procedures, medication administered and equipment used on December 7, 2011, the charts for that day were examined (see Table 1 for relevant details). Seven endoscopes were used that day and most patients were given intravenous anesthetic (propofol), lidocaine and fentanyl. Some patients had biopsies of their intestinal tract taken at the time of their procedure(s). Only one patient chart, for Case 2 (the suspected source Case), indicated that they were given two doses of anesthetic during their procedure. Matching Virus Strains Cases 1, 2 and 3 were all found to be HCV serotype 1b by the Ontario Public Health Laboratory (PHOL) and were HCV-RNA positive. Case 4 was found to be type 1 but was tested before subgenotyping was routinely performed and was initially HCV-RNA negative likely due to HCV treatment. Blood samples for Cases 1, 2 and 3 were sent to the National Microbiology Laboratory (NML) operated by the Public Health Agency of Canada in Winnipeg, Manitoba, where the samples' genetic sequences were analyzed. Expert opinion from the NML Microbiologist indicated that all three of the HCV viruses from these three patients were genetically highly related (see Appendix A-1a and Appendix A-1b HCV Phylogenetic Trees, two regions of the HCV genome were sequenced). Consultation with an infectious diseases specialist also confirmed that Case 2's HCV-RNA level was sufficient (1.84 X 10 7 in July 2012) to be the source of HCV for Cases 1 and 3 (Personal Communication Dr. Tony Mazzulli). During the investigation, Case 4 was asked to submit a blood sample to determine if there was sufficient HCV genetic material remaining to analyze. This blood test drawn on January 16, 2014 showed that Case 4 was once again HCV-RNA positive. The blood sample was sent to Downsview Endoscopy Clinic HCV Outbreak Final Report (October 6, 2014) 2

3 the NML where it was compared to the viruses from Cases 1, 2 and 3. Again this virus was found to be genetically highly related to the HCV viruses found in samples from the other three patients (Cases 1, 2 and 3) (see Appendix A-1c HCV Phylogenetic Tree). Case 5 had blood drawn on January 25, 2014 which confirmed the Case's HCV-RNA negative status. Case 5 was HCV positive prior to their procedure at the DEC, so no attempt was made to match this Case's HCV with Cases 1, 2 or 3. Infection Prevention and Control Investigation Reports from the College of Physicians and Surgeons of Ontario (CPSO) Out of Hospital (OOH) Inspection Program were reviewed. The DEC was first visited by the CPSO OOH Inspection Program on March 10, 2010, resulting in a Conditional Pass. Most of the issues detected during the inspection were not germane to the outbreak investigation. The report for this first inspection highlighted that a curtain was used to separate the clean and decontamination areas and documentation of drug use was poor including missing controlled substance (i.e. narcotic) logs. The clinic was inspected again on September 20, 2011, and again received a Conditional Pass. The clinic had separated the decontamination area by constructing a separately ventilated area for re-processing the endoscopes but the CPSO repeated its concern that anesthesiologists were not signing out the exact dose of narcotics used for each patient. On November 23, 2012 the clinic was inspected again and received a Pass. A TPH Associate Medical Officer of Health and a manager of the TPH Control of Infectious Diseases/ Infection Control (CID/IC) Program with infection prevention and control expertise, visited the DEC on November 21, 2013, to complete an infection prevention and control (IPAC) review. The clinic consisted of the following rooms: a large waiting room that could hold approximately 10 patients with a large reception desk where the binder containing the clinic policies and procedures was stored, a small room for dictation used by the health professionals as their office during their time at the DEC, two essentially identical procedure rooms which were not marked to differentiate them in any way. Each room was spacious and well organized with a medication cart with supplies for the administration of drugs and equipment for emergency resuscitation, a large room that contained a desk and chairs for a pre-procedure interview (where insertion of venous access by the anesthesiologist occurred) and three post-procedure recovery bays with monitoring equipment, separated from each other and the main room by curtains. The desk in this large room was also used to document patient activities and had locked drawers for medication storage, a separate area for record storage, set aside from the large room above by curtains, a separate small room with a very large sink where the two endoscope re-processor machines were located which had a separate ventilation system constructed after the initial OOH inspection in March During the visit the reprocessing procedures for the endoscopes as well as the patient care practices were observed. Both the endoscopist and the anesthesiologist who worked on December 7, 2011 had ceased working at the DEC before the investigation began. The storage Downsview Endoscopy Clinic HCV Outbreak Final Report (October 6, 2014) 3

4 and use of multi-dose medication vials was reviewed and the DEC s policies and procedures were also briefly reviewed. Overall infection prevention and control activities such as cleaning and disinfection were also noted as were the products used for cleaning and their disposal. On December 10, 2013, TPH's CID/IC manager conducted a follow-up visit to: review the findings of the November 21, 2013 visit, more thoroughly review the clinic's IPAC procedures and records of re-processing of the endoscopes and request additional medication records. No concerns regarding the cleaning and disinfection of the clinic environment (including the procedure rooms) were identified during these visits. Appropriate products were being used to clean surfaces and disposed of as expected. The processing of the endoscopes appeared to be conducted according to accepted standards using appropriate equipment and the disinfectant was tested daily. The one staff person who performed re-processing was appropriately trained. Equipment used in re-processing the endoscopes was cleaned between uses and stored appropriately. Biopsy forceps used to take small samples of bowel wall from the patients (see Table 1) were single use and discarded after each patient. Multi-dose vials (50 ml) of anesthetic (propofol 10 mg/ml)) and narcotic (2 ml) (fentanyl 50 ug/ml) were seen, were appropriately stored and their use was confirmed through questioning of the clinic owner. Bottles of lidocaine (50 ml) were seen opened on medication carts in the two procedure rooms but they were not used by the anesthesiologist practising on the day of the visit. The following recommendations were made by TPH's CID/IC manager during the December 10, 2013 visit: the clinic visibly number the procedure rooms and record the room number in the patient chart, document the review of clinic IPAC procedures with new staff prior to initiation of work, better document the training received by all clinic staff which should be done annually at a minimum, ensure that the manager of the clinic has sufficient IPAC training, including knowledge of the re-processing of the endoscopes, so that proper oversight of all clinic procedures is ensured. Attempts were made to gather records for equipment and medication used in December This would confirm the types of multi-dose vials that were used and that the correct cleaning and disinfectant solutions were available to clean the clinic environment and support appropriate re-processing of the endoscopes. The only record that was available was for propofol ( ml vials) that was ordered in August Narcotic control logs were reviewed from December 7, They recorded only the number of vials of narcotic that were taken out that day by the anesthesiologist but they did not record the exact vials returned at the end of the day or explicitly link which vials were used with which patient. The records showed that 10 vials of narcotic were taken that morning. Downsview Endoscopy Clinic HCV Outbreak Final Report (October 6, 2014) 4

5 Medication Administration: Investigation TPH's AMOH discussed the anesthesiologist's past practices at the clinic with him via telephone on November 26, 2013, December 19, 2013 and May 12, 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 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. The endoscopist was interviewed on December 16, He described the procedures he used to perform endoscopy at the DEC in general. He had no role in preparing or administering intravenous medication. He indicated that he could clearly tell the difference between an endoscope that had been cleaned before use and one that had just been used. There was a record keeping error on December 7, 2011, and it appears that an endoscope was used on two consecutive patients without time for proper re-processing (see Table 1). The clinician was asked directly about this and the endoscopist indicated that he would have been aware of an endoscope that was left in a room and accidentally prepared for use without being reprocessed. Our observation of the process for removing the endoscope from the room after a procedure makes it unlikely that an endoscope was reused without being re-processed as the bins were clearly marked dirty and clean. The owner indicated that the nurse who recorded the endoscope number on each chart did so from memory rather than from direct observation of the endoscopes as they were being used. This may have lead to this error. Additional Case Finding December 7, 8 and 10, 2011 Due to the high risk of other patients seen on December 7, 2011 being exposed to HCV, the remaining nine patients seen that day were contacted by letter and HCV testing was recommended. Attempts were made to reinforce the recommendation for HCV testing by telephone with all nine patients. As well, because HCV can last up to four days in the environment (4), patients seen in the subsequent four days (December 8 and 10, 2011, the clinic was not open on December 9 or 11) were also contacted by letter to prompt HCV testing. Case 1 was also known to be positive for HBV. Therefore, HBV testing was also recommended for patients seen on all three days. The 13 staff who worked at the clinic during these four days were also contacted by letter to prompt HCV/HBV testing. Appendix B shows the number of patients and staff contacted by each method. All patients seen on December 7, 2011, or their family member, were contacted by telephone and all patients Downsview Endoscopy Clinic HCV Outbreak Final Report (October 6, 2014) 5

6 were tested for HCV and HBV. No additional cases of HCV or HBV were detected. Of the 39 patients seen on December 8 and 10, 2011, 22 were tested for HCV and HBV. A patient seen on December 10, 2011 was found to be HCV antibody positive (RNA negative) but was known to be HCV-positive in Of the 13 staff, 7 were tested and all were negative. Patient Look-back Investigation On June 2, 2014, TPH commenced an extended look back in order to determine if there were other days when transmission of HCV or HBV could have occurred at the DEC. TPH requested a list of patients who had a procedure at the DEC in the five years prior to the date of transmission (December 7, 2011) and were cared for by the anaesthesiologist who worked on that day. TPH received a list of 216 patients who had procedures from September 27, 2010 to December 7, The DEC opened in September, This list was submitted to PHO on August 6, 2014 and was compared to all records of individual cases of reported HCV or HBV in Ontario. This resulted in the identification of nine patients with HBV and an additional three patients with HCV not associated with the outbreak. All of these infections were identified before the patients had their procedure at the DEC. Therefore, no evidence of transmission of HCV or HBV on days other than December 7, 2011 was found. Discussion This investigation showed that three patients (Cases 1, 3 and 4), acquired HCV during their endoscopic procedure at the DEC on December 7, A source patient previously infected with HCV was seen at the clinic before all three of these patients were seen. As well, the source patient s (Case 2) HCV virus and the virus present in all three HCV-positive patients (Cases 1, 3 and 4) were shown to be highly related through genetic sequencing at the National Microbiology Laboratory. Without the ability to observe the practices of the two physicians (anesthesiologist and endoscopist) who performed the procedures that day, the investigation relied on interviews of these two individuals and a detailed chart examination. The policies and procedures used by the clinic were also reviewed and infection prevention and control activities, including reprocessing of the endoscopes, were observed. The findings from these components of the investigation were placed into context through a review of the relevant literature which includes descriptions of previous examples of transmission of HCV during endoscopic procedures (5) (6) (7). Theoretically, contamination of the endoscopes could have resulted in HCV transmission. However, the same endoscope was not used on all four individuals (the source and three cases, see Table 1) so contamination of some component of the cleaning and re-processing equipment would have had to occur to allow all of the endoscopes to be the source of the same virus. During the observation of the re-processing of the endoscopes, rigorous cleaning of all components used during this process was seen that would have eliminated HCV. The reprocessing technician appeared well trained and knowledgeable and cleaning solutions were tested appropriately to ensure potency. Therefore, this hypothesis seems unlikely. Downsview Endoscopy Clinic HCV Outbreak Final Report (October 6, 2014) 6

7 HCV transmission has often been documented as being linked to mis-handling of multi-dose injectable medications (3). Therefore, the investigation focused on collecting as much information about the processes used by the anesthesiologist that day as possible including gathering information about the packaging of the drugs used during this period. The anesthesiologist indicated that one 20 ml syringe (propofol 20 ml plus 5 ml xylocaine) was used for each patient and discarded so it is unlikely that this propofol syringe becoming contaminated from the source patient lead to this transmission to three other patients. His description of the use of propofol with 20 ml syringes also matches the doses recorded in the charts which were all about 200 mg which was 20 ml of propofol (10 mg/ml). According to clinic records, propofol came in ml vials. Doses for about four or five patients would have come from this one vial. It is not possible to definitively assign the vials used that day to each patient as this was not recorded. As well, doses for two patients were not recorded making it impossible to make any determination of when one vial was exhausted and another vial opened. It is possible that if a ml vial was opened in each procedure room at the start of the day and Patient B, Case 2, 1, 3 and 4 were seen in that order in one procedure room, one vial would have been used on all five of these patients (see Table 1). If the anesthesiologist drew up an additional 10 ml dose of propofol to give to Case 2 with the same syringe and needle just used on this Case, this would have contaminated the propofol vial. This could have exposed the other three cases to HCV. The anesthesiologist's description of the process for preparing and using fentanyl would not lead to transmission of the virus from Case 2 to Cases 1, 3 and 4. There is ug of fentanyl in each vial (50 ug/ml, 2 ml vials). Approximately 20 to 40 ug of fentanyl was used for each patient except for those patients undergoing gastroscopy who did not receive fentanyl. Therefore, the 10 ml syringe would have lasted only until Patient D (see Table 1) and then a new fentanyl syringe would have been prepared. However, if the anesthesiologist used a 20 ml syringe for fentanyl, drawing up two vials of narcotic and 16 ml of saline, this syringe would have held 200 ug of narcotic. It would have been used until Patient G, providing the possibility that contamination of this syringe may have exposed Cases 1 and 3 to HCV. However, Case 4 who became HCV positive did not receive fentanyl as the Case underwent gastroscopy only. Therefore, contamination of the narcotic medication leading to transmission to all of these three patients does not seem likely. Case 2's December 7, 2011 chart indicated two separate doses of propofol were given, the only chart from that day marked this way. The first 200 mg dose emptied a 20 ml syringe (according to the anesthesiologist). The second dose recorded was mg, aligned with the explanation provided by the anesthesiologist that he prepared a 20 ml syringe containing 10 ml of anesthetic to be ready for use when another propofol dose was necessary. If the anesthesiologist discarded both these syringes as he explained, no contamination of any medication vials would have resulted. The first 20 ml syringe that had just been used on Case 2 was contaminated with HCVcontaining blood. For this transmission to occur that needle must have found its way into a bottle of medication subsequently used on Cases 1, 3, and 4. The second largest vial of medication in use that day was the 50 ml vials of lidocaine used to prepare anesthetic syringes of propofol. If the needle used on Case 2 was subsequently put into the vial of lidocaine to Downsview Endoscopy Clinic HCV Outbreak Final Report (October 6, 2014) 7

8 prepare a subsequent dose for Case 2 (since the chart indicates another dose was given) that would contaminate a sufficiently large vial of medication to expose Cases 1, 3 and 4 to HCV. As well, all three Cases received propofol/lidocaine that day. There is no way of confirming this possibility. However, looking at the order of patients seen that day, HCV-infected patients seem to alternate with patients who did not become infected. This might occur if the patients are put into two rooms alternatively and the lidocaine vial in one of the two rooms became contaminated. Except for two patients seen between Case 2 and Case 1, there is always one HCV-negative patient between the three patients who became infected that day. It is not known when the vial of lidocaine was opened and whether two separate vials of lidocaine were opened at the same time (as was seen during the visit on November 21, 2013). So again, this possibility cannot be confirmed. Conclusion Three patients became infected with HCV during their procedures at the DEC. Genetic analysis showed their HCV and the HCV of a previously infected patient seen at the DEC that day were highly related. Since two procedure rooms were in operation at the DEC it is possible that either a vial of propofol anesthetic or a vial of lidocaine (used to reduce the sting of the anesthetic) became contaminated. TPH has notified the three patients who became infected with HCV during their procedure(s) on December 7, 2011 at the DEC of this outbreak. Information on the risk of exposure to HCV and HBV was also provided to patients seen the same day as these three patients and those seen on December 8 and 10, 2011, along with recommendations for testing. In addition, TPH conducted a look-back of patients who had a procedure at the DEC during the period from September 27, 2010 (when DEC opened) to the date of transmission (December 7, 2011) 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. 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. Downsview Endoscopy Clinic HCV Outbreak Final Report (October 6, 2014) 8

9 References 1) Hepatitis C Virus Transmission at an Outpatient Hemodialysis Unit New York, Morbidity and Mortality Weekly Report, vol. 58(8), March 6, ) 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, ) Healthcare-Associated Hepatitis B and C Outbreaks Reported to the Centers for Disease Control and Prevention (CDC) in available at 4) 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 ) 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, ) Patient-to-patient transmission of hepatitis C virus (HCV) during colonoscopy diagnosis. Virology Journal, vol. 7, 2010, pp ) Multiple Clusters of Hepatitis Virus Infections Associated With Anesthesia for Outpatient Endoscopy Procedures. Gastroenterology, vol. 139, 2010, pp ) Global Epidemiology of Hepatitis C Virus Infection: New Estimates of Age-Specific Antibody to HCV Seroprevalence. Hepatology, vol. 57, 2013, pp Downsview Endoscopy Clinic HCV Outbreak Final Report (October 6, 2014) 9

10 Appendix A-1a HCV Phylogenetic Tree Downsview Endoscopy Clinic Case 1 = H5856/13 Case 2 = H5857/13 Case 3 = H5855/ H0297/12 3rd H1283/12 H0297/12 2nd H0297/12 H1284/12 H1459/13 H0500/12 H1464/13 H6447/12 H1753/13 H4073/13 H5856/13 H5855/13 H5857/13 Tor-011 H3439/12 H6455/12 H5858/12 1b-HCV-S1 AF H0708/13 H2298/13 H1755/13 H2882/13 H0878/13 H1462/13 H4284/12 H4283/12 H2038/13 H1152/13 H2035/13 H6811/12 H2036/13 H4703/13 H1754/13 H0595/12 H6611/12 H4432/13 1b-HPCJCG D90208 H5860/12 H5192/13 H5193/13 H5194/13 H2903/12 H4430/13 H5018/12 H2712/12 H4282/12 1b-HCVT094 AB b-HPCHUMR M58335 H5859/12 H2033/13 H6453/12 H1463/13 H4743/ H2884/ c-India AY c-HC-G9 D14853 H0293/12 H4427/13 H4431/13 H4707/13 H4433/13 H4434/13 H4435/13 Pos E1 H0294/12 H0296/12 1a-H77-AF a-M a-HCV-1 M a-pHCV-1/SF9 AF a-K3a D a-NZL1 D17763 HCV 1B HCV1A 0.1

11 Appendix A-1b HCV Phylogenetic Tree Downsview Endoscopy Clinic Case 1 = H5856/13 Case 2 = H5857/13 Case 3 = H5855/13 H4700/ H5855/13 H5857/13 H5856/13 H1755/13 H2298/13 H1459/13 H1464/13 H1753/13 H4073/13 H0878/13 H2036/13 H1462/13 H4703/13 H1463/13 1b-HCVT122(AB049101) H1754/13 1b-HCV-K1-S1(D50483) H2038/13 H1152/13 H5194/13 H5192/13 H5193/13 H2035/13 H2882/13 H2033/13 1b-HCV-TR1(AF483269) 1b-HC-J4(AF054247) 1b-HCV-N(AF139594) H0708/13 1b-(J:D90208) H4432/13 1c-(G9:D14853) H4433/13 H4705/13 H4708/13 H4706/13 H4434/13 H4701/13 H4702/13 1a-HCV-1(M62321) 1a-(M67463) 1a-(H77:AF011751) a-CB(AF046866) 3a-(NZL1:D17763) 3a-Th85(D14308) TOR-011 HCV 1B HCV 1A 0.2

12 Appendix A-1c HCV Phylogenetic Tree Downsview Endocsopy Clinic Case 1 = H5856/13 and H14/0483,4,5 Case 2 = H5857/13 Case 3 = H5855/13 and H Case 4 = H14/ H4282/ b-HCVT094 AB H2712/12 H5018/ H2903/12 90 H4430/13 0 H2882/13 H1755/13 1 H0708/13 07 H2298/13 17 H6811/12 7 H2036/13 H4703/13 0 H4743/12 21 H3439/12 0 H6455/ H5858/ b-HCV-S1 AF H4283/12 7 H2038/13 H1152/ H2035/13 H4284/12 18 H0878/ H1462/13 0 H5860/12 H4432/13 1 H14/0553 1b 17 H H5194/13 46 H5192/13 49 H5193/13 12 H5859/12 H2033/ H6453/12 43 H1463/13 86 H5855/13 70 H H14/0482 1b H5857/13 86 H5856/13 H14/0483 1b 99 H14/0484 1b H14/0485 1b H4073/13 34 H0500/12 11 H1753/13 32 H6447/12 23 H1464/13 26 H1459/13 27 H1284/12 17 H0297/12 86 H0297/12 2nd 99 H0297/12 3rd 99 H1283/12 H1754/13 H0595/12 H6611/12 H4427/13 1a-HCV-1 M a-H77-AF a-M67463 H2884/13 3a-K3a D a-NZL1 D

13 Appendix B Follow-up and Testing Patients and Staff Downsview Endoscopy Clinic 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 Patients Day of Transmission 07-Dec-11 14* 5* (%) Subsequent Days of Clinic Operations 08-Dec (31.6%) 10-Dec ** (80.0%) Total ** (66.0%) Staff Dec (53.8%) *Index and source cases are included. **This individual was previously infected and is HCV-RNA negative. ***Testing status is unknown for 22 individuals. Two patients notified TPH that they were not undergoing testing.

14 Table 1 PATIENTS SEEN - DECEMBER 7TH, DOWNSVIEW ENDOSCOPY CLINIC Number Patient Start Time End Time Procedure Types Biopsy Propofol Dose (mg) Fentanyl Dose (ug) Nurse (removing venus access) Scope # 1 Patient A 8:05 8:11 Gastroscopy YES unknown * na 8: Patient B 8:25 8:29 Gastroscopy YES 150 na ** *** 3 Patient C 8:36 8:59 Colonoscopy YES : Case 2-9:05 9:21 Gastroscopy & YES : HCV+ Colonoscopy 5 Patient D 9:35 9:44 Colonoscopy No : Patient E 10:00 10:04 Gastroscopy YES 150 na 10: Case 1 - HCV+ 10:15 10:28 Gastroscopy & Colonoscopy YES unknown * 20 10: Patient F 10:35 10:46 Colonoscopy YES : Case 3-10:54 11:05 Colonoscopy YES : HCV+ 10 Patient G 11:15 11:26 Colonoscopy YES : Case 4-11:35 11:39 Gastroscopy YES na 11: HCV+ 12 Patient H 11:49 11:59 Colonoscopy No : Case 5-12:05 12:17 Colonoscopy No : HCV+ 14 Patient I 12:26 12:30 Colonoscopy YES : na = not applicable, the anaesthesiologist indicated that fentanyl was not given to patients undergoing gastroscopy * the dose for this patient was not recorded ** the time that the venous access was removed was not recorded *** this was an error that was noticed during the chart review Note: Only one endoscopist and one anaesthesiologist practised at the clinic on December 7, 2011.