In 1999, our center implemented a policy of outpatient protocol biopsies as standard practice for the clinical management of pediatric renal allograft recipients. In order to determine the safety of this procedure, we conducted a retrospective chart audit of all outpatient renal allograft biopsies performed at our center. Biopsies were performed under conscious (midazolam) or procedural (propofol/fentanyl) sedation. Localization of the lower pole of the renal allograft was achieved with renal ultrasound. Using a Biopty gun with a 16-gauge needle, two cores were obtained. Patients were discharged four h post-biopsy. Patient demographics, hospital length of stay (LOS), specimen adequacy (per Banff criteria) and major and minor adverse events were recorded in a central database. Data were expressed as mean +/- SD. From June 1999 to July 2004, we performed 162 biopsies in 43 pediatric renal allograft recipients. Most patients underwent extraperitoneal transplantation (42/43, 97.7%) and were greater than five yr of age at biopsy (129/131 biopsies, 98.5%). The majority of these procedures (131/162, 80.9%) were conducted in the outpatient department, with 113 of 131 (86.3%) being obtained for protocol (n = 89) and one-month follow-up acute rejection therapy (n = 24) indications. Patients underwent 3.7 +/- 2.7 biopsies (range = 1-11). Specimen adequacy was achieved in 119 of 124 (96.0%) of documented cases. The overall incidence of adverse events was 12 of 131 (9.2%) biopsies, all of which were minor in severity. Macroscopic hematuria was the most common minor adverse event, occurring after 11 of 131 (8.4%) biopsies. While macroscopic hematuria prolonged LOS (adverse events vs. no adverse events: 23.0 +/- 26.0 vs. 8.6 +/- 4.1 h, p = 0), none of these episodes required major surgical or radiographic interventions. We conclude that in patients greater than five yr of age with extraperitoneal renal allografts, outpatient protocol biopsies using a 16-gauge needle are sufficiently safe to justify their inclusion in the routine clinical management of pediatric renal allograft recipients and in pediatric clinical trials.