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Standardization of Patient Selection for Office Based Laboratory Procedures
Julia Kleene, MD1, Jeffrey Hnath, MD2, Courtney Warner, MD2, Yaron Sternbach, MD2, R. Clement Darling, III, MD2.
1Albany Medical College, Albany, NY, USA, 2The Vascular Group, Albany, NY, USA.

Objective: The proliferation of office-based laboratories (OBL) has raised safety concerns about appropriate patient selection by state regulators and credentialing services. The purpose of this study is to determine the effects of a formal patient selection protocol on hospital admission and mortality rates. Methods: A formal outpatient selection protocol was instituted 4/29/16 for our OBL at the request of our credentialing service. The checklist included, cardiac events, stroke, body mass index less than 45, sleep apnea, AICD implantation, ASA class less than 4, and prior anesthesia issues. Outcomes were compared using chi square analysis and student T-test. Results: 9/1/15 to 4/12/16 1453 procedures (angiography[433, 30.4%] dialysis access[287, 19.7%], vein procedures[614, 42.6%], other[119, 8.19%]) were performed at our OBL and 711 were performed in the hospital (angiogram [507, 71.3%], dialysis access [65, 9.1%], vein procedures[90, 12.7%], other [50, 7.0%]). 4/29/16 to 9/22/16 980 procedures (angiography [296, 27.4%], dialysis access[166, 16.9%], vein procedures [435, 44.3%], other [83, 8.43%]) were performed at our OBL and 582 procedures (angiogram[381, 65.5%], dialysis access[83, 14.3%], vein procedures[63, 10.8%], other[56, 9.62%]) in the hospital. The indications (aneurysm [2.92%v1.54%,P .28] claudication [8.5%v.10.6%,P .21] gangrene [11.9%v.8.7%,P .062], non-healing ulcer [19.4% v. 18.7%,P .76], rest pain [14.0%, 10.6%, P.056] other [25.4% v. 25.3%,P .98)did not change for each site after the protocol initiation except for a higher percentage of dialysis access cases(10.3% - 19.9%,P <.05] shifted to the hospital and more venous cases [8.86% v. 4.30%,P< .001] shifted to the OBL. 30 day death rates (7, [.81%] vs. 1, [.18%],P .13) and 72 hour emergency room visits (17, [1.9%] vs. 15 , [2.8%], P.30) did not change with use of the protocol respectively. Of the pre-protocol deaths, 1 died post procedure day 1, the rest died late (post procedure day #6, 25, 24,29,27,27). The post-protocol death was day #6 after an inpatient operative procedure. Only 3 deaths (2 cardiac, 1 COPD) and 5 72-hour emergency room visits would have been excluded (4 COPD, 1 obesity) from the OBL by the protocol. Conclusion:The OBL setting has raised safety concerns regarding proper patient selection resulting in a demand for a standardized patient selection protocol. Institution of a formal selection process did not prove superior to physician judgement in terms of hospital admission and mortality rates.

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