1124 infection control & hospital epidemiology october 2015, vol. 36, no. 10


figure 1a. Hepatitis C virus (HCV) genetic fingerprinting results for genotype 1a from site A. Phylogenetic tree of genotype 1a HCV E1/E2 sequences from 1 case patient (B6, shaded), 10 proximal patients (B1-5, B7-10, and B15), and 2 non-related reference patients (ENR1-2) from site A. Single genome sequences (average of 20 sequences per sample, range 10–24 sequences) were aligned with MUSCLE, and a neighbor-joining tree was created using Geneious, employing a Jukes-Cantor distance model with 1000 bootstrap replications. Scale bar represents percent nucleotide variability.


The facility took immediate action and discontinued use as of January 10, 2013.12


Internal VA review board/subject matter expert panels


determined that epidemiologic investigations were warranted. In February 2013, patients at risk from both facilities were identified, and a lookback investigation was initiated. At-risk patients included inpatients receiving glargine insulin from Lantus SoloSTAR pens from October 19, 2010, through December 31, 2012, at facility A and Community Living Center and acute care inpatients receiving insulin from Lantus SoloSTAR pens, Detemir Flexpens, and Novolog Flexpens from October 5, 2010, through January 10, 2013, at Facility B, and were identified using VA’s electronic health record and Corporate Data Warehouse bar-coded medication adminis- tration data. Date ranges for patient identification included start of insulin pen usage in these facilities and continued past the time of discontinuation to ensure all potential exposure patients were identified. Facilities notified patients of their possible exposure; the patients were then offered and verbally consented to BBP testing for HBV, HCV, and HIV. Patients whose potential exposure occurred less than 6 months before time of testing were requested to return for repeat testing.


Laboratory and clinical data for exposed patients were reviewed to determine pre–insulin pen exposure serologic status for HBV, HCV, and HIV infection and confirmation of insulin receipt using an insulin pen. Records from all VA facilities visited by patients were reviewed, going back as far as electronic health record documentation was available along with available Department of Defense and civilian medical records in VA’s electronic health record. Since the goal was to assess BBP infection transmission risk among individuals exposed to reused insulin pens, it was considered an urgent public health investigation and did not require VA or facility institutional review board approval.13 Case (“newly identified”) patients were defined as having


positive post–insulin pen exposure serologic test results for HBV (hepatitis B surface antigen [HbsAg] or core total antibody [HbcAb] positive), HCV (HCV antibody [HCV Ab] positive with confirmatory antibody testing with alternative assays) or HIV (HIV-1 antibody [HIV Ab] and Western blot positive) infection, had been an inpatient at the facility during the defined period, and had either negative or no serologic test- ing documented in VA’s electronic health record prior to insulin pen exposure. Potential proximate (“previously infected”) patients were those with positive pre–insulin pen


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76  |  Page 77  |  Page 78  |  Page 79  |  Page 80  |  Page 81  |  Page 82  |  Page 83  |  Page 84  |  Page 85  |  Page 86  |  Page 87  |  Page 88  |  Page 89  |  Page 90  |  Page 91  |  Page 92  |  Page 93  |  Page 94  |  Page 95  |  Page 96  |  Page 97  |  Page 98  |  Page 99  |  Page 100  |  Page 101  |  Page 102  |  Page 103  |  Page 104  |  Page 105  |  Page 106  |  Page 107  |  Page 108  |  Page 109  |  Page 110  |  Page 111  |  Page 112  |  Page 113  |  Page 114  |  Page 115  |  Page 116  |  Page 117  |  Page 118  |  Page 119  |  Page 120  |  Page 121  |  Page 122  |  Page 123  |  Page 124  |  Page 125  |  Page 126  |  Page 127  |  Page 128  |  Page 129  |  Page 130  |  Page 131  |  Page 132  |  Page 133  |  Page 134  |  Page 135  |  Page 136  |  Page 137  |  Page 138  |  Page 139  |  Page 140