SBIR Phase II: Development of a Track-and-Trace Medication Barcoded Label

小型企业创新研究(SBIR)第一阶段项目的更广泛影响/商业潜力旨在改善医疗患者的结果，潜在地拯救生命，并降低医疗成本。2013年的《药品质量和安全法》(Drug Quality And Security Act)为无菌注射复合药物设定了更严格的制造标准，导致许多第三方供应商关闭，从而造成短缺和价格上涨。作为回应，美国医院药剂师协会预计，到2018年，美国市场的40%，2000家医院将接受内源性化合物。内源医院希望以更高质量的产品降低成本，改善患者安全。如今，内包医院通常有多个信息系统，并使用纸质记录，拼凑出化合物是如何制成的，以及给谁管理过。当发生成分召回时，医院会花费数百个工时来确定问题根源和受影响的患者。为了防止进一步的患者风险，速度是必需的。这个SBIR第一阶段项目将为医院提供端到端质量管理的能力，跟踪每个生产过程步骤，并跟踪患者的药物。医院将能够防止患者接受召回的药物，并确定高质量的生产妥协，从而改善患者的结果，并可能挽救生命。拟议的项目是一种新的药物条形码标签加密技术，与现有的医院扫描仪兼容，提供跟踪和追踪静脉注射药物化合物的能力。主要目标包括患者特定的和预期的带有标签的工作流程，用于复合质量控制的被动审计管理系统，以及改善手术室环境药物条形码扫描合规性的创新。今天，医疗保健提供者利用多个条形码标签技术，在不同的系统中嵌入最少的药物数据。药物标签可能是这些系统之间的纽带，以实现成分可追溯性。然而，现有的解决方案不足以满足2013年的立法可追溯性任务。该项目发明将加密条形码标签中的序列化字段，该条形码标签将特定药物连接到其生产数据，并最终连接到患者。配制过程数据，如成分、环境条件和生产说明，将连接到单独的药物标签并存储在患者S的电子病历中。当成分被召回或发现有问题的过程时，提取算法将从EHR中提取加密数据，并将其连接到生产数据。该项目的成功将在于现有医院扫描仪的标签可读性和从电子病历检索序列化数据

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is aimed at improving healthcare patient outcomes, potentially saving lives, and decreasing healthcare costs. The Drug Quality and Security Act of 2013 set stricter manufacturing standards on sterile injectable compounded medications that have closed many third party suppliers, thus creating shortages and higher prices. In response, the American Society of Hospital Pharmacists expects 40% of the US market, 2000 hospitals, by 2018 to receive insourced compounds. Hospitals that insource hope to decrease their costs and improve patient safety with higher quality product. Today, insourcing hospitals often have multiple information systems and use paper records cobbling together how a compound is made and to whom it has been administered. When an ingredient recall occurs, hospitals spend hundreds of man-hours identifying the problem source and affected patients. To prevent further patient risks speed is demanded. This SBIR Phase I project will provide hospitals the capability of an end-to-end quality management that will track every production process step and tracing medications to patients. Hospitals will be able to prevent patients from receiving recalled medications and identify quality production compromises thus improving patient outcomes and potentially saving lives. The proposed project is a novel medication barcoded label encryption technology compatible with existing hospital scanners to provide track and trace capabilities of intravenous medication compounds. Key objectives include both patient specific and anticipatory workflows with labels, a Passive Auditing management system for compounding quality control, and an innovation to improve operating room environment medication barcode scanning compliance. Today, healthcare providers utilize multiple barcoded label technologies with minimal embedded medication data across disparate systems. Medication labels could be the link across these systems for ingredient traceability. However, existing solutions are inadequate to meet 2013 legislative traceability mandates. The project invention will encrypt serialization fields within the barcoded label connecting a specific medication to its production data, and eventually to the patient. Compounding process data, such as ingredients, environmental conditions, and production instructions, will be connected to individual medication labels and stored in the patient?s electronic record. When an ingredient is recalled or questionable process identified, an extraction algorithm will pull the encrypted data from the EHR and will be connected to production data. Success of this project will be label readability by existing hospital scanners and retrieval of the serialized data from the EHR