Subject MI 81639 10/18/16 This Plan of Correction is in response to the State of Michigan Department of Licensing and Regulatory Affairs investigation of Complaint MI1881639 and its findings relative to MCL 333.20131, MCL 333.20132, MCL333.21521, MCL 33.21513, and R 325.1024. We believe that this Plan of Correction, when fully implemented, will address the findings relative to the aforementioned Code and Administrative Rules Minimum Standards for Hospitals. The CSP Department: Has no robust, consistent, repeatable, comprehensively documented, and well maintained training system for new and existing employees and management. Evidence of training of employees and competencies on general and specific processes were listed on sign-in sheets kept in binders. Nearly all of the trainings for 2015 and 2016 lacked associated content and subject matter materials. DMC and the CSP Department did not have a system or process in place to offer training to employees that did not appear to sign-in and attend the initial training, nor did the CSP Department The DMC Infection Control Officer and the Infection Preventionists responsible for the individual hospitals have reviewed and approved all training and competency documents to confirm alignment with DMC Infection Control Policies. (9/15/16) The Manager of Central Processing in collaboration with Unity Health Trust developed a baseline skills assessment tool for Central Sterile Processing staff. The Manager of Central Processing, the Operating Room educators, Central Sterile Processing educators and supplemental Central Sterile Processing staff implemented the tool and completed the baseline assessments for Instrument Associates which included Prep and Pack, Decontamination, Case Carts, Sterilization, Repairs /replacement stock. The assessment for Central The Infection Control Officer and the Infection Preventionist for each hospital will conduct weekly monitoring of Operating Rooms and Central Sterile Processing using the following audit tools: Operating Room Infection Control Surgical Review Tool, Environmental Services Operating Room Survey Infection Prevention Tool, and the Sterile Processing Tracer Tool. (Ongoing) The Unity Health Director and Managers of Central Sterile Processing began daily Quality Control checks on September 19, 2016. The quality control checks include inspection of instruments for cleanliness, rust, lack of bio burden, and proper positioning (open verses closed); inspection of retractors, heavy
Supply Associates addressed Disinfection, Decontamination, Case Carts, Peel Packs, and Case Cart Delivery. (Training 9/29/16) outline a system of training for new employees. Follow-up training was also not offered at a later date. Evidence of the pertinent training subject matter was either unavailable, not on the DMC premises, or remained in control of medical equipment suppliers and unavailable at the time of the investigation. The content of the June 29, 2016 training, Surgical Instrument Testing & Inspection Practices by Integrated Medical Systems (IMS) was not immediately available for review and had to be located by DMC staff Upon completion of the baseline skills assessment the Manager of Central Sterile Processing, the Central Sterile Processing Educator and the Operating Room Educators conducted competency assessments of all Central Sterile Processing personnel including verification of skills for cleaning and sorting of instruments, and the sterilization of trays. Competency assessment was documented for each employee. (9/29/16) Competency requirements have been incorporated into new employee orientation and annual reorientation. The Chief Executive Officer engaged an external central sterile processing education and training resource, Integrated Medical Systems International, Inc. (IMS) to provide both on-site and web based training modules that can be used to provide additional training of Central Sterile Processing personnel. (9/13/16) 1) The training content is taken from AAMI Standards (ST79) and the two professional references (The International Association of Healthcare Central Service Materiel Management and The Certification Board for Sterile Processing and Distribution). instruments and strung instruments for functionality; evaluation of the use of tip protectors. These checks will continue on a random basis for the next four months or until there is 100% compliance for a minimum of four consecutive months. After reaching sustained compliance for four consecutive months the frequency of the monitoring process will be reevaluated by the Perioperative Task Force. (9/19/16 and ongoing) The results of audits conducted in Central Sterile Processing are sent to the Director of Clinical Quality Improvement for each hospital. The Director of Clinical Quality Improvement reviews and analyzes the data. This information is sent to the DMC Director of Quality for aggregation and analysis. Results are reported to the site Chief Operating Officer, Regional Chief Nurse Executive, the Infection Control Committee, Environment of Care Committee, Leadership Performance Improvement Coordinating Committee (LPICC), Perioperative Task Force, the Perioperative Council, the Joint Conference Committee and ultimately the Governing Board at their regularly scheduled meetings for review and action as required. (10/28/16 and ongoing) The Infection Control Officer or qualified designee will monitor the documentation of training and the content quarterly on an ongoing basis. Any identified discrepancies will be DMC Plan of Correction LA/SW/LC 1013/16
2) The content is accessible to all employees in hard copy form. Copies are kept in CSP and are available to staff. The training modules are reviewed by the IMS Forms Committee every two years. 3) Tracking is performed by the IMS Educator via an electronic spreadsheet with completion certificates placed in employee files. 4) The training manuals include: a) Standard Operating Procedures b) Critical Tasks Performed in Decontamination, and c) Critical Tasks Performed in Assembly, d) Critical Tasks Performed in Sterilization Areas, and e) Quality. corrected immediately. The Manager of Central Sterile Processing, the Central Sterile Processing Educator will aggregate and report the results of training and competency assessments to the Perioperative Task Force annually and when changes are made to the content. Four (4) CSP employee records were randomly selected and examined for training and competency. There appeared to be no consistent process or procedure for employees across the board, nor was there proof of employees with the same job title receiving the All training and educational materials have been incorporated into a consistent, repeatable, comprehensively documented, training system for new and existing employees and management. The Manager of Central Sterile Processing and the Central Sterile Processing Educator are responsible for maintaining the documentation of education and training as well as the annual evaluation of competencies in the Central Sterile Processing employee files. The Infection Control Officer, the Manager of Central Sterile Processing and the Educator reviewed the Central Sterile Processing staff job descriptions to include job qualifications, experience and specific training and certification requirements. (9/24/16) The Manager of Central Sterile Processing maintains the employee files including the documentation of training and competency. Evidence of education and competency include sign in sheets along with the affiliated subject matter content. The Chief Human Resources Director or qualified DMC Plan of Correction LA/SW/LC 1013/16
A review of all employee files for Central Sterile Processing staff was conducted to identify individuals requiring additional training, education and competencies. As noted above, 100% of employee competency has been conducted, and is now documented in the employee file. (9/1/16) same level of CSP training. Furthermore, employee Job Performance Evaluation Worksheets either lacked statements pertaining to the employees competency or training level. designee will audit the Central Sterile Processing employee files quarterly and on an ongoing basis for accuracy and completeness. There appeared to be a lack of collaborative sharing, communication, and process consistency between the operating rooms and the CSP Department. The Interim Administrative Director of Perioperative Services at DMC stated, CSP handles their own training. She also acknowledged difficulty between the prior CSP operators and managers, the resulting turnover of management staff, and the new operators in Unity Health Trust. Central Sterile Processing Staff not present for the skills assessment or verification of competency cannot return to work in their usual position/role until the education and competency has been completed. The Detroit Medical Center s (DMC) Chief Operating Officer and Chief Medical Officer, have created a DMC Perioperative Improvement Task Force who is responsible for development and implementation of performance measurements for all perioperative services including Central Sterile Processing, with a focus on aseptic cleaning procedures of operating rooms and the cleaning, processing and sterilization of surgical instrumentation. The Task Force will evaluate compliance with quality control requirements, electronic risk management reports (i.e. incident reports), Immediate Use Steam Sterilization rates, Surgical Site Infection rates and other issues associated with the perioperative environment. (9/6/16) The Perioperative Improvement Task Force will Unity Health Trust, as the management of Central Sterile Processing also oversees the Operating Room Liaisons which assess the Operating Rooms on a daily basis using the Operating Room Liaison Tracking Tool. Assessment includes Operating Room trays, Operating Room case carts, and Operating Room post-case pre- cleaning processes. The Operating Room Liaisons will document outcomes to Unity HealthTrust management daily to promote process consistency between the operating rooms and CSP department. Assessments will continue until there is 100% compliance for a minimum of four consecutive months. After reaching sustained compliance for four consecutive months the frequency of the monitoring process will be reevaluated by the Perioperative Task Force. (9/1/16 and ongoing) DMC Plan of Correction LA/SW/LC 1013/16
meet daily until all corrective actions have been fully implemented and monthly thereafter. The Task Force will report its findings to the Council on a monthly basis. DMC Plan of Correction LA/SW/LC 1013/16