Stöver T, Plontke S K, Guntinas-Lichius O, Welkoborsky H-J, Zahnert T, Delank K W, Deitmer T, Esser D, Dietz A, Wienke A, Loth A, Dazert S
Klinik für Hals‑, Nasen‑, Ohrenheilkunde, Universitätsklinikum Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt, Deutschland.
Klinik für Hals‑, Nasen‑, Ohrenheilkunde, Kopf- und Halschirurgie, Universitätsmedizin Halle, Halle (Saale), Deutschland.
HNO. 2023 Jun;71(6):396-407. doi: 10.1007/s00106-023-01305-x. Epub 2023 Apr 28.
A standardized and structured process is indispensable for optimal hearing rehabilitation with cochlear implants (CI). The Executive Committee of the German Society of Otorhinolaryngology, Head and Neck Surgery (DGHNO-KHC), initiated the conception of a certification system and a Whitepaper based on the Association of the Scientific Medical Societies in Germany (AWMF) clinical practice guideline (CPG) describing the current medical standards of CI care in Germany. The goal was to independently confirm implementation of this CPG and make this information publicly available. With the support of an independent certification organization, successful implementation of the CI-CPG by a hospital would then be verified and confirmed by awarding the "Cochlear implant-provision institution" (Cochlea-Implantat-versorgende Einrichtung, CIVE) quality certificate. A structure for implementation of a certification system was developed based on the CI-CPG. The following steps were required: 1) conception of a quality control system for certification of hospitals working in accordance with the CI-CPG; 2) development of required structures for an independent review of quality-relevant structure, process, and result parameters; 3) development of a standard procedure for independent certification of hospitals; 4) development of a certificate and a logo to demonstrate successful certification; 5) practical implementation of the certification. Following design of the certification system and the required organizational structure, the certification system was successfully launched in 2021. Applications for the quality certificate could be formally submitted from September 2021. A total of 51 off-site evaluations were performed by December 2022. In the first 16 months from introduction, 47 hospitals were successfully certified as CIVE. In this period, 20 experts were trained as auditors, who have since then carried out 18 on-site audits in hospitals. In summary, the conceptual design, structure, and practical implementation of a certification system for quality control in CI care was successfully implemented in Germany.
对于人工耳蜗（CI）的最佳听力康复而言，标准化和结构化的流程必不可少。德国耳鼻咽喉头颈外科学会（DGHNO-KHC）执行委员会根据德国科学医学协会联合会（AWMF）的临床实践指南（CPG），发起了认证系统和白皮书的构想，该指南描述了德国CI护理的当前医疗标准。目标是独立确认该CPG的实施情况并公开此信息。在独立认证组织的支持下，医院成功实施CI-CPG将通过授予“人工耳蜗供应机构”（Cochlea-Implantat-versorgende Einrichtung，CIVE）质量证书来进行验证和确认。基于CI-CPG开发了认证系统的实施结构。需要以下步骤：1）构思针对按照CI-CPG开展工作的医院进行认证的质量控制系统；2）开发对与质量相关的结构、流程和结果参数进行独立审查所需的结构；3）制定医院独立认证的标准程序；4）开发证书和标志以证明认证成功；5）认证的实际实施。在设计认证系统和所需的组织结构之后，认证系统于2021年成功启动。质量证书申请于2021年9月正式受理。截至2022年12月共进行了51次非现场评估。在引入后的前16个月中，47家医院成功获得CIVE认证。在此期间，20名专家接受了审核员培训，此后他们在医院进行了18次现场审核。总之，CI护理质量控制认证系统的概念设计、结构和实际实施在德国成功实现。
