WISE QUALITY america SERVICES CREATING A SUSTAINABLE FOUNDATION FOR QUALITY, PATIENT SAFETY, AND ORGANIZATIONAL FINANCIAL PERFORMANCE Wise Quality America (WQA) is a leading expert on transforming all of your quality efforts into a highly functioning Quality Engine that creates enhanced revenue through increased efficiency by reducing variation, increasing revenue through cost avoidance strategies and leveraging the demands of Centers for Medicare and Medicaid Services and other third party payors, while significantly improving patient outcomes. We are also experts in the implementation of ISO 9001 in healthcare organizations of all sizes and modalities. We offer services in a highly collegial interface with our clients. We assign qualified staff who are educated in the applicable standards or regulations and who have relevant healthcare experience. During site visits, they work closely with your staff to assess the current state of the organization’s clinical workflow, documentation, and management processes. Feedback is immediate and non-punitive. Our goal is to help you succeed. _________________________________________________________ SECTION 1: ISO 9001 A LA CARTE PROGRAMS Our ISO implementation services, offer very specific, project-based options for hospitals already on an ISO path or just beginning the journey. In every case, our goal is to see hospitals become fully ISO compliant, which means they are trained to implement ISO 9001 and empowered to sustain their success. Our project-based services below provide a clear roadmap for healthcare staff and delivers confidence to all stakeholders, including patients, board members, insurers, regulatory agencies and other related entities. ISO 9001 Standards: The Basics This half-day, one coach training course is for those that want to know and understand the ISO 9001 Standard and how it is implemented in healthcare. Basic implementation strategies are included. ISO 9001:2015 Standards Update This is a 2-coach; one day training session to explain the changes to the ISO 9001 Standard that is anticipated to become effective in September 2015. Internal Audit Techniques to Include Tracer Methodology This is a highly interactive and hands-on course to train individuals to perform the internal audits required by the ISO 9001 Standard. This course includes segments that take the participants through actual internal audits. These audits are mentored by WQA coaches and will count toward your required audits for ISO 9001 Compliance or Certification. This course takes the participants through the required elements of internal audits. We will review the relevant policy and develop the checklists to perform the audit. We will then perform the audits and write the audit summary reports. The intent is to complete the steps necessary to take the organization from performing the audits to the point where the findings are ready for introduction into Management Review. This course includes the ISO Standards: The Basics. Corrective and Preventive Action: Identification, Documentation, and Follow-Up This course is intended for those organizations that have a solid Internal Audit Program and struggle with Corrective and Preventive Action and its importance in Management Review. This program will lead the organization through a process to either define and document or, if already established, align the corrective action and preventive action processes with the requirements of the ISO 9001 Standard. This will consist of verifying the identification of inputs to these processes, the methods for establishing corrective action and preventive action plans, determining the required follow-up activity and criteria for closing corrective actions and/or deploying preventive action plans within the QMS system reporting structure. ISO 9001 BIOMED VBP CMS EMERGENCY MGT DNV LSC 8190-A Beechmont Ave Suite 314 Cincinnati, OH 45255 (513) 947-8340 www.wisequality.com REVISED SEPT 2014 Development of the Six Documented Procedures This 1-day, 2-coach training course includes a high level overview of the ISO 9001 Standard as it specifically relates to the development of the required Six Documented Procedures. Basic implementation strategies are included. Draft documents of the Six Documented Procedures can be completed by the end of the day. The ISO 9001 Standard: The Basics course is a prerequisite for this course. Management Overview This 3-hour, one coach course is designed for the Executive Team and/or Board of Directors. It is a high level overview of the requirements of ISO 9001 with a focus on ISO Clause 5: Management Responsibility. It is presented in a clear and concise format that allows the participants to understand their responsibilities, as stated in the ISO Standards, to ensure compliance with the strict requirements for top management. ISO 9001 Quality Management System Pre-Assessment Survey This is a survey performed to determine readiness for an ISO 9001 Compliance or Certification audit. The activities include a review of pertinent policies and procedures and the utilization of tracer methodology to determine clinical compliance and effectiveness in patient units, ancillary areas, and off-sites as appropriate. A comprehensive building tour will be performed that includes all aspects of the Physical Environment. You will receive a report outlining exactly what you have yet to revise or complete for a successful actual survey. We will remain available to you until the completion of your actual survey and surrounding activities. NIAHO may be included at no extra charge. NOTE: MORE OFFERINGS RELATIVE TO THE PHYSICAL ENVIRONMENT ARE INCLUDED IN SECTION 3 SECTION 2: CENTERS FOR MEDICARE/MEDICAID SERVICES From our foundation as process and standards experts, we also offer a series of programs designed to boost a hospital’s quality performance and ensure success in meeting key external criteria/requirements and credible and adequate response to CMS validation or patient complaint surveys. CMS Rescue: CMS Conditions of Participation Gap Analysis or Corrective Action Evaluation & Deployment This is accomplished through an in-depth evaluation of the Organization’s compliance with the Centers for Medicare and Medicaid Services’ Conditions of Participation (CoP). If this survey is performed in response to any on-going positive findings by CMS, there will be a particular emphasis in clearing those non-conformities. The activities include a review of pertinent policies and procedures and the utilization of tracer methodology to determine clinical compliance and effectiveness in patient units, ancillary areas, and off-sites as appropriate. A comprehensive building tour will be performed that includes all aspects of the Physical Environment, including the CoP particular emphasis on Life Safety. CMS Rescue: System Improvement Agreement (SIA) Preparation and Implementation WQA will provide independent expert assistance in complying with the requirements of the Systems Improvement Agreement (SIA) between the Centers of Medicaid and Medicare Services (CMS) and your Organization. We will meet your needs and the requirements of CMS as outlined in the SIA, including consultation, timelines and required reporting. SECTION 3: PHYSICAL ENVIRONMENT Life Safety to include Hazmat, Staff Safety and Security of Staff, Patients, and Visitors This includes comprehensive facility tours and document review with an emphasis on the following: • Life Safety: This addresses issues as required by CMS, including a complete review of the CMS “K-list” to ensure compliance with an Accreditation Organization survey or CMS survey and/or validation audit. • Staff Safety: This addresses the safety of hospital staff. This includes a complete review of OSHA “must-haves” that will affect not only the well being of the staff, but will also recognize hazards that the hospital must mitigate. These are hazards that could result in findings by an Accreditation Organization (AO) or CMS. • Security: This addresses all aspects of the security of hospital staff, patients, and visitors. Security issues are often not addressed by code so it is in the best interest of the hospital to learn all possible considerations and hazards that arise in creating a strong Security Management System. A review of the hospital Workplace Violence Prevention Program as well as a complete review of abduction and elopement prevention procedures, medication security, laboratory access, and other areas critical in developing a strong security system is included. In addition, consideration will be given to security in all-hazard events including shooters, chemical contamination, and cyber related attacks. ISO 9001 BIOMED VBP CMS EMERGENCY MGT DNV LSC 8190-A Beechmont Ave Suite 314 Cincinnati, OH 45255 (513) 947-8340 www.wisequality.com 2 Emergency Management Plan This includes a comprehensive review of the hospital’s Emergency Operation Plan (EOP), including a study of the Hazard Vulnerability Analysis (HVA), to identify where risk associated with these events can be mitigated. An analysis will include the documentation and implementation of critical aspects of the EOP. These critical aspects will include communication systems, safeguarding and/or transfer of patients, identification of in-coming patients and emergency personnel, provisions for alternative critical utility systems, provisions for critical supplies, compliance with required disaster drills, as well as other requirements. Biomedical Equipment Management Plan This analysis will be a comprehensive review of the Medical Equipment Management Plan, including the ISO 9001 Standard’s requirements for documentation, calibration, verification, and determination of the criticality of all medical equipment and devices. This will include planned maintenance schedules and work order system implementation, as well as a tour of the facility to ensure the storage and usage of the equipment is safe and appropriate. SECTION 4: QUALITY OPERATING SYSTEM CERTIFICATION PROGRAM The Certification Program is a journey that integrates all of your quality efforts into a highly functioning Quality Operating System (QOS) driven by a powerful Quality Engine (QE). This results in enhanced revenues through increased efficiency by reducing variation and creating additional revenue opportunities and cost avoidance strategies. Patient safety will be at the core of everything you do. You will be coached on how to leverage the demands of the Centers for Medicare and Medicaid Services (CMS) and other third party payors, while significantly improving patient outcomes. The program is a tiered approach to Certification that requires your organization to move through seven levels of compliance with associated metrics. These Levels will steadily guide and coach your organization to a robust Quality Operating System that will lead to revenue enhancement and an environment that is safe and satisfying for all your customers, both internal and external. You may be exempt from certain levels due to your prior implementation of that function. If Certification is not your goal, the Organization may choose to complete the levels in any order or may select some levels and not others, with one stipulation. The Organization must complete the training on BOS System Guidelines (see below) as the first step. Beyond that, the order or exclusion is up to you in terms of the selection of Stages and/or Levels. Completing the first 4 Stages of the Program will also prepare a Hospital to seek ISO 9001 Certification and/or the Baldrige Award. STAGE 1 LEVEL 1 GAP ANALYSIS OF EXISTING QUALITY PROGRAM: This includes identification of the organization’s processes, customers (internal and external), suppliers, work environment, technical equipment, and relevant information on staff and their competence. Existing patient outcomes along with regulatory and licensing requirements will be evaluated to identify areas of excellence as well as opportunities for improvement. Following the gap analysis, we will provide a detailed report and to-do list to move the organization forward to a successful outcome. TRAINING ON BOS SYSTEM GUIDELINES The system design guidelines used in this program are based on a document called the Business Operating Systems (BOS) for Health Care Organizations: Requirements for Process Improvements to Achieve Excellence. The BOS is based on the ISO 9004 Standard and the Baldrige criteria that has been adapted for use in health services organizations, with guidance and terminology specific to healthcare. The goal of the BOS document is to aid in the development or improvement of a fundamental quality management system for health service organizations that provides for continual improvement, emphasizing error or adverse outcomes prevention, and the reduction of variation and organizational waste. This document considers both the effectiveness and efficiency of the quality management system, and consequently the potential for improvement. ISO 9001 BIOMED VBP CMS EMERGENCY MGT DNV LSC 8190-A Beechmont Ave Suite 314 Cincinnati, OH 45255 (513) 947-8340 www.wisequality.com 3 STAGE 2 LEVEL 1 TRAINING: PERFORMING INTERNAL AUDITS (optional if previously implemented in the Organization) This is a highly interactive and hands-on course to train individuals to perform the internal audits required by the ISO 9001 Standard. This course includes segments that take the participants through actual internal audits. This course takes the participants through all required elements of internal audits. We will review the relevant policy and develop the checklists to perform the audit. We will then perform the audits and write the audit summary reports. The intent is to complete the steps necessary to take the organization from performing the audits to the point where they are ready for introduction into Management Review. STAGE 3 LEVEL 2 BUILDING AND DEPLOYING THE QUALITY ENGINE AT THE ORGANIZATION LEVEL We begin to build the Quality Engine to power the Quality Operating Plan. This starts with the organization’s Strategic Plan. Where are you going? Who are you going to be? How are you going to get there? What are all the things you need to do in order to accomplish the objectives established by the Strategic Plan? Included are all those things you need to define that will constitute the Quality Engine’s (QE) processes. They are all of the actions required to deliver products and services to patients/customers in a way that meets or exceeds their expectations, thereby creating an enthusiastic relationship with the organization’s patients/customers. How critical this enthusiastic relationship with your patients/customers is to the organization’s success may be obvious, but organizations often fail to effectively communicate the importance of this to all levels of their organization. In order to establish an effective mechanism for communicating this important tenant, the organization must establish a structure that is specifically designed to accomplish this objective. Defining, documenting and deploying a Quality Operating Plan that requires all entity departmental, and/or component levels of the organization to identify and document certain things best facilitates this. STAGE 4 LEVEL 3 BUILDING AND DEPLOYING THE QUALITY ENGINE AT THE DEPARTMENT OR COMPONENT LEVEL Once the Quality Operating System is established, documented and deployed at the organizational, facility or system level, the Quality Engine is completed by defining, documenting and deploying system engine components at the entity, departmental and/or component levels. Each entity, department and/or component shall be required to establish a quality plan to include the aforementioned organizational quality plan components including: • Identification of specific customers • Identification of the products/services they deliver to these customers • Identification, definition, sequence and interactions of their primary processes documented in their specific Quality Engine system diagram • Appropriate process documentation • Appropriate monitoring and measurement activities • Establishment of a process user team focused on process management and continual improvement activities and engagement in required reporting activities at appropriate functions and levels throughout the organization. Entities, departments and/or component levels are not required to establish any organizational wide processes but rather, they are required to comply with all organizational level processes (policies, procedures, management plans, etc.). Documents required supporting the entity, departmental and/or component quality plan are: • Organization chart • Quality Engine system diagram of the entity, departmental and/or component part depicting the sequence and interactions of their primary processes • A list of indicators identifying data that is being collected and utilized to demonstrate their ability to meet stated objectives • A performance indicator grid providing information relative to the entity, department and/or component’s ability to meet performance, outcome, customer satisfaction and Quality Engine (QMS) requirements ISO 9001 BIOMED VBP CMS EMERGENCY MGT DNV LSC 8190-A Beechmont Ave Suite 314 Cincinnati, OH 45255 (513) 947-8340 www.wisequality.com 4 STAGE 5 LEVEL 4 TRAINING ON BASIC PROCESS IMPROVEMENT TOOLS (OPTIONAL) This Program Level is training in some basic process improvement tools including Affinity diagrams, Cause and Effect, Control Charts, Flowcharts, Histogram, Pareto Charts, Run Charts, and more. ADVANCED PROCESS MAPPING OF THE CONTINUUM OF CARE An organization must arm itself to deal with existing and new regulatory and payor requirements by putting itself in the necessary position of creatively managing healthcare across entities throughout the continuum of care. New requirements from CMS, ACA and other payors requires a much more significant focus by the organization on driving throughput, coordination of care, management of transitions within the hospital setting as well as post hospitalization transitions and the coordination of post hospitalization activities such as patient and caregiver education needs, compliance with medication requirements and post hospitalization services (e.g. rehab, home care, DME and follow-up appointments etc.) and post hospitalization communications (e.g. phone calls and other forms of communication to assure patient compliance and access to outpatient services if indicated or needed). STAGE 6 LEVEL 5 ON-SITE SURVEY OF COMPLIANCE WITH CMS CONDITIONS OF PARTICIPATION REGULATIONS, 42 CFR PART 482 (LATEST REVISION) This will be evaluated by an on-site survey of all regulatory compliance. Any non-conformity will require an action plan and follow-up for validation. This validation may take place on-site or off-site, depending on the non-conformity and the activities required to validate correction. STAGE 7 LEVEL 6 DEVELOP. MAINTAIN, AND SUBMIT METRICS The organization will be required to develop and maintain metrics that must be submitted to WQA quarterly. The metrics will be created and designed by the organization, depending on their own strategic and business plans. The balanced scorecard must demonstrate a nexus between the Quality Operating System and the strategic plan and be meaningful to the business plan by addressing finance and internal growth. These may be current metrics being monitored or different metrics pertinent to new opportunities for improvement not previously identified or directly monitored. The metrics must include measurement of the satisfaction of customers and other interested parties. STAGE 8 LEVEL 7 FINAL VALIDATION OF SUCCESSFUL IMPLEMENTATION OF QUALITY OPERATING SYSTEM This on-site review will be to validate that all requirements outlined in Levels One through Six have been met. Perfection is not an expectation, but continuous meaningful improvement is a requirement. This validation will be conducted through document review, chart review, staff interviews, and observation of the work environment and work processes. CONTACT INFORMATION: WISE QUALITY AMERICA 8190-A Beechmont Ave. Suite 314 Cincinnati, OH 45255 (513) 947-8340 [email protected] www.wisequality.com ISO 9001 BIOMED VBP CMS EMERGENCY MGT DNV LSC 8190-A Beechmont Ave Suite 314 Cincinnati, OH 45255 (513) 947-8340 www.wisequality.com 5