Quality Improvement and Patient Safety (QPS) Ratchada Prakongsai Senior Manager

Quality Improvement and Patient Safety (QPS) Ratchada Prakongsai Senior Manager

Overview 2 Comprehensive approach to quality improvement and patient safety that impacts all aspects of the facility s operation. department-level input and participation into the quality improvement and patient safety program; use of objective, validated data to measure how well processes work; effectively using data and benchmarks to focus the program; implementing and sustaining changes that result in improvement Both quality improvement and patient safety programs are leadership driven; seek to change the culture of an organization; proactively identify and reduce variation; use data to focus on priority issues; and seek to demonstrate sustainable improvements

Overview 12 Standards 53 Measurable Elements 5 Required Policies 3 Management of Quality and Patient Safety Activities (QPS.1) Measure Selection and Data Collection (QPS.2, 3) Analysis and Validation of Measurement Data (QPS 4, 4.1, 5, 6, 7, 8, 9 Gaining and Sustaining Improvement (QPS 10, 11)

4 MANAGEMENT OF QUALITY AND PATIENT SAFETY

Management of Quality and Patient Safety 5 The overall program for quality and patient safety in a hospital is approved by the governing entity (GLD.2), with the hospital s leadership defining the structure and allocating resources required to implement the program (GLD.4). Leadership also identifies the hospital s overall priorities for measurement and improvement (GLD.5), with the department/service leaders identifying the priorities for measurement and improvement within their department/service (GLD.11 and GLD.11.1). This QPS chapter identify the structure, leadership, and activities to support the data collection, data analysis, and quality improvement for the identified priorities hospitalwide, as well as department- and service-specific. This includes the collection and analysis on, and the response to, hospitalwide sentinel events, adverse events, and near-miss events. The standards also describe the central role of coordinating all the quality improvement and patient safety initiatives in the hospital and providing guidance and direction for staff training and communication of quality and patient safety information.

Management of Quality and Patient Safety 6 QPS.1 - A qualified individual guides the implementation of the hospital s program for quality improvement and patient safety and manages the activities needed to carry out an effective program of continuous quality improvement and patient safety within the hospital. P Require well-implement program Approve and support resources form governance knowledge and experience staff in data collection, data validation, and data analysis Coordinate and organize throughout the organization Understand how to take the hospital wide priorities and the department/service level priorities Training and communication

8 Management of Quality and Patient Safety QPS.1 Measurable Elements 1.An individual who is experienced is selected to guide the implementation of the quality and patient safety program 2.The individual with oversight for the quality program selects and supports qualified staff for the program 3.Support and coordination to department/ service leader across the hospital 4.Implement a training program for all staff 5.Regular communication of quality issues to all staff

MEASURE SELECTION AND DATA COLLECTION 9

Measure Selection and Data Collection 10 QPS.2 Quality and patient safety program staff support the measure selection process throughout the hospital and provide coordination and integration of measurement activities throughout the hospital. Measure selection is a leadership responsibility. The leadership of the hospital decides the priority areas to measure for the entire hospital (GLD.5) The measure selection process for each department/service. (GLD.11 and GLD.11.1) All departments and services clinical and managerial select measures related to their priorities.

Measure Selection and Data Collection 11 Indicator Selection Standard Indicator Guideline USA : The Joint Commission Library of Measures (LOM) : Joint Commission International Agency for Healthcare Research and Quality (AHRQ) The healthcare accreditation institute (Thailand) Best practice Core service Risk Assessment Occurrence / Complaint Medical record Audit Tracer result

Measure Selection and Data Collection 12

Measure Selection and Data Collection 13 QPS.2 Measurable Elements 1. Quality program supports the selection of measures. 2. Quality program coordinate and integration of measurement activities throughout the hospital. 3. Quality program provides for the integration of event reporting systems, safety culture measures and others to facilitate integrated solution and improvement. 4. Tracks progress on the planned collection of measure data.

Measure Selection and Data Collection 14 QPS.3 The quality and patient safety program uses current scientific and other information to support patient care, health professional education, clinical research, and management. Health care practitioners, researchers, educators, and managers often need information to assist with their responsibilities. Such information may include scientific and management literature, clinical practice guidelines, research findings, and educational methodologies. The Internet, print materials in a library, online search sources, and personal materials are all valuable sources of current information.

Measure Selection and Data Collection 15

Measure Selection and Data Collection 16 QPS.3 Measurable Elements 1. Current scientific and other information supports patient care. 2. Current scientific and other information support clinical education. 3. Current scientific and other information support research. 4. Current scientific and other information support management. 5. Information is provided in a time frame that meets user expectations.

ANALYSIS AND VALIDATION OF MEASUREMENT DATA 17

18 Analysis and Validation of Measurement Data QPS.4 The quality and patient safety program includes the aggregation and analysis of data to support patient care, hospital management, and the quality management program and participation in external databases. Aggregate data provide a profile of the hospital over time and allow the comparison of the hospital s performance with other organizations, particularly on the hospitalwide measures selected by leadership. In particular, aggregate data from risk management, utility system management, infection prevention and control, and utilization review can help the hospital understand its current performance and identify opportunities for improvement. External databases also are valuable in the ongoing monitoring of professional practice as described in SQE.11. A hospital can compare itself to that of other similar hospitals locally, nationally, and internationally.

Analysis and Validation of Measurement Data 19 QPS.4 Measurable Elements 1. Process to aggregate data. 2. Support patient care, hospital management, professional practice review, and the overall quality and patient safety program 3. Provided to agencies outside when required by laws or regulations. 4. Contribute and learn from external databases for comparison purposes. 5. Security and confidentiality are maintained when using external databases

Analysis and Validation of Measurement Data 20 Compared with standard / best practices Compared with itself over time

Analysis and Validation of Measurement Data 21 Compared with other similar organizations

Analysis and Validation of Measurement Data 22 QPS.4.1 Individuals with appropriate experience, knowledge, and skills systematically aggregate and analyze data in the hospital. Data analysis involves individuals who understand information management, have skills in data aggregation methods, and know how to use various statistical tools. Results of data analysis need to be reported to those individuals responsible for the process or outcome being measured and who can take action on the results. Thus, data analysis provides continuous feedback of quality management information to help those individuals make decisions and continuously improve clinical and managerial processes. The frequency of aggregated and analyzed process depends on the activity or area being measured and the frequency of the measurement.

23 Analysis and Validation of Measurement Data The goal of data analysis is to be able to compare a hospital in four ways: 1. With itself over time : month to month, or one year to the next 2. With other similar organizations :reference databases 3. With standards : accrediting and professional bodies, laws or regulations 4. With recognized desirable practices : best or better practices or practice guidelines

24 Analysis and Validation of Measurement Data QPS.4 Measurable Elements 1. Data are aggregated, analyzed, and transformed into useful information to identify opportunities for improvement. 2. Individuals with appropriate clinical or managerial experience, knowledge, and skills participate in the process. 3. Statistical tools and techniques are used 4. The frequency of data analysis is appropriate to the process or outcome being studied. 5. Results of analysis are reported to those accountable for taking action. (GLD.1.2, ME 2) 6. Data analysis supports comparisons internally over time, including comparisons with databases of like organizations, with best practices, and with objective scientific professional sources.

Analysis and Validation of Measurement Data 25

Analysis and Validation of Measurement Data 26 QPS.5 The data analysis process includes at least one determination per year of the impact of hospitalwide priority improvements on cost and efficiency. The quality and patient safety program includes an analysis of the impact of priority improvements as supported by leadership (GLD.5). There is evidence to support that the use of clinical practice guidelines to standardize care has a significant impact on efficiency of care and a reduction in the length of stay, which ultimately reduces costs. The quality and patient safety program staff develop tools to evaluate the use of resources for the existing process and then reevaluate the use of resources for the improved process. The analysis will provide useful information on which improvements impact efficiency and therefore cost.

27 Analysis and Validation of Measurement Data QPS.5 Measurable Elements 1. At least one impact analysis of cost efficiency per year of an improvement project 2. Evaluate and re-evaluate the use of resources for the current and improved process and Coordination with other departments: HR, IT, Finance 3. Report result to leadership

Analysis and Validation of Measurement Data 28

29 Analysis and Validation of Measurement Data QPS.6 The hospital uses an internal process to validate data. P Data validation is most important when.. a) evaluate and improve an important clinical process or outcome; b) data will be made public on the hospital s website or in other ways; c) a change has been made to an existing measure ; the data collection tools changed etc. d) the data resulting from an existing measure have changed in an unexplainable way; e) the data source has changed ; part of the patient record turned into an electronic format f) the subject of the data collection has changed ; research protocol alterations, new practice guidelines implemented, or new technologies and treatment methodologies introduced etc.

Analysis and Validation of Measurement Data 30 Data validation is an important tool for understanding the quality of the data and for establishing the level of confidence decision makers can have in the data. Data validation becomes one of the steps in the process of setting priorities for measurement, selecting what is to be measured, extracting or collecting the data, analyzing the data, and using the findings for improvement. When a hospital publishes data on clinical outcomes, patient safety, or other areas, or in other ways makes data public, such as on the hospital s website, the hospital has an ethical obligation to provide the public with accurate information. Hospital leadership is accountable for ensuring that the data are valid. Reliability and validity of measurement and quality of data can be established through the hospital s internal data validation process or, alternatively, can be judged by an independent third party, such as an external company contracted by the hospital. (GLD.6)

Analysis and Validation of Measurement Data 31

Sample of Data validation 32 1 st abstractor 2 nd abstractor

33 Analysis and Validation of Measurement Data QPS.6 Measurable Elements 1. Data validation is used as a component of the improvement process selected by leadership. 2. Data are validated when any of the conditions noted in a) through f) in the intent are met. 3. An established methodology for data validation is used. 4. Hospital leadership assumes accountability for the validity of the quality and outcome data made public

Analysis and Validation of Measurement Data 34 QPS.7 The hospital uses a defined process for identifying and managing sentinel events. P A sentinel event is an unanticipated occurrence involving death or serious physical or psychological injury. Serious physical injury specifically includes loss of limb or function. Such events are called sentinel because they signal the need for immediate investigation and response. Establishes an operational definition of a sentinel event that includes at least a) an unanticipated death, b) major permanent loss of function unrelated to the patient s natural course of illness or underlying condition; c) wrong-site, wrong-procedure, wrong-patient surgery; d) transmission of a chronic or fatal disease or illness as a result of infusing blood or blood products or transplanting contaminated organs or tissues; e) infant abduction or an infant sent home with the wrong parents; and f) rape, workplace violence ; assault, homicide (willful killing) of a patient

35 Analysis and Validation of Measurement Data Accurate details of the event are essential to a credible root cause analysis, thus the root cause analysis needs to be performed as soon after the event as possible. The analysis and action plan is completed within 45 days of the event or becoming aware of the event. prevent or reduce the risk of such sentinel events recurring, the hospital redesigns the processes and takes whatever other actions

36 Analysis and Validation of Measurement Data New QPS. 7 Measurable Elements 1. Hospital leadership has established a definition of a sentinel event that at least includes a) through f ) found in the intent. 2. The hospital completes a root cause analysis of all sentinel events and in a time period specified by hospital leadership that does not exceed 45 days from the date of the event or when made aware of the event. 3. The root cause analysis identifies the origins of the event that may lead to improvements and/or actions to prevent or reduce the risk of the sentinel event recurring. 4. Hospital leadership takes action on the results of the root cause analysis Sentinel event and medical error are not synonymous. An incident as a sentinel event is not an indicator of legal liability.

37 Analysis and Validation of Measurement Data Survey Tip QPS.7 Will look for you to have done a credible RCA down to the origin of the event Then, how did you use/apply that key information In fact, this could be used prospectively towards a possible new process and in the form of FMEA Some RCAs are too superficial; watch policy definitions

38 Analysis and Validation of Measurement Data QPS.8 Data are always analyzed when undesirable trends and variation are evident from the data. P The hospital collects data on diverse and different areas of patient care services periodically. In order to do so there must be reliable mechanisms of reporting outcomes to ensure quality services. Those that pose patient safety risk are identified and monitored. Data collection should be sufficient to detect trends and patterns and will vary depending on the service frequency and/or the risk for patients.

Analysis and Validation of Measurement Data 39 Data gathering and analysis are conducted for at least the following: a) All confirmed transfusion reactions, if applicable to the hospital (COP.3.3) b) All serious adverse drug events, if applicable and as defined by the hospital (MMU.7, ME 3) c) All significant medication errors, if applicable and as defined by the hospital (MMU.7.1, ME 2) d) All major discrepancies between preoperative and postoperative diagnoses; for example, a preoperative diagnosis of intestinal obstruction and a postoperative diagnosis of ruptured abdominal aortic aneurysm (AAA) e) Adverse events or patterns of adverse events during procedural sedation regardless of administration site (ASC.3.2 and ASC.5) f ) Adverse events or patterns during anesthesia regardless of administration site g) Other adverse events; for example, health care associated infections and infectious disease outbreaks (PCI.7.1, ME 6) Intense analysis & Improvement

40 Analysis and Validation of Measurement Data New New New QPS.8 Measurable Elements of 1. Defined data gathering processes are developed and implemented to ensure accurate data gathering, analysis, and reporting. 2. Intense analysis of data takes place when adverse levels, patterns, or trends occur. 3. Data gathering and analysis are performed on items a) through g) of the intent. 4. Results of analyses are used to implement actions to improve the quality and safety of the service, treatment, or function. (PCI.10, ME 3) 5. Outcome data are reported to the governing entity as part of the quality improvement and patient safety program. (GLD.4.1, ME 1)

41 Analysis and Validation of Measurement Data Surveyor Tips: QPS.8 What are your sources of data? Think more than just closed record reviews: occurrence reports (Online to Quality Program?); open record reviews; daily rounds related to KPIs Make your data results work for you; try something Keep a track record of all that goes to Governance

Analysis and Validation of Measurement Data 42 QPS.9 The organization uses a defined process for the identification and analysis of near-miss events. Near miss = Any process variation that did not affect an outcome but for which a recurrence carries a significant chance of a serious adverse outcome. Such a near miss falls within the scope of the definition of an adverse event. Adverse event = An unanticipated, undesirable, or potentially dangerous occurrence in a health care organization. First, the hospital establishes a definition of a near miss and what types of events are to be reported. Near miss applies to more than potential medication errors. Near misses also include other types of adverse events. Second, a reporting mechanism is put into place, and finally there is a process to aggregate and analyze the data to learn where proactive process changes will reduce or eliminate the related event or near miss. (MMU.7.1 and QPS.11)

Analysis and Validation of Measurement Data Reporting System Work Flow

44 Analysis and Validation of Measurement Data QPS.9 Measurable Elements 1. Establishes a definition of a near miss 2. Defines types of events are to be reported. 3. Establishes the process for the reporting of near misses 4. The data are analyzed and actions taken to reduce near-miss events

45 GAINING AND SUSTAINING IMPROVEMENT

Gaining and Sustaining Improvement 46 QPS.10 Improvement in quality and safety is achieved and sustained. The information from data analysis is used to identify potential improvements or to reduce (or prevent) adverse events. After an improvement(s) is planned, data are collected during a test period to demonstrate that the planned change was actually an improvement. To ensure that the improvement is sustained, measurement data are then collected for ongoing analysis. Effective changes are incorporated into standard operating procedure, and any necessary staff education is carried out. The hospital documents those improvements achieved and sustained as part of its quality management and improvement program. ( GLD.11, ME 4)

Unit Performance Measurement flow 47 A Risk Profile / Risk Assessment Unit Performance Measurement B Prioritization CQI

48 Gaining and Sustaining Improvement QPS.10 Measurable Elements 1. Improvements in quality and patient safety are planned, tested, and implemented 2. Data demonstrates that improvements are effective and sustained 3. Policy changes necessary to plan, to carry out, and to sustain the improvement are made. 4. Successful improvements are documented.

49 Gaining and Sustaining Improvement QPS.11 Risk management program is used to identify and to proactively reduce unanticipated adverse events and other safety risks to patients and staff. P Categories of risks include 1. strategic (those associated with organizational goals); 2. operational (plans developed to achieve organizational goals); 3. financial (safeguarding assets); 4. compliance (adherence to laws and regulations); and 5. reputational (the image perceived by the public). Formalized risk management program a) risk identification; b) risk prioritization; c) risk reporting; d) risk management, to include risk analysis (MMU.7.1, QPS.7, QPS.8, and QPS.9); and e) management of related claims

Gaining and Sustaining Improvement 50 New QPS.11 Measurable Elements 1. Risk management framework includes a) through e) in the intent. 2.Leadership identifies and prioritizes potential risks associated with at least the strategic, financial, and operational functions of the hospital. 3. At least annually, a proactive risk-reduction is conducted on one of the priority risk processes. (FMEA, HVA or Similar tools) 4. High-risk processes are redesigned based on the analysis of the test results.

Gaining and Sustaining Improvement 51 Surveyor Tips: QPS.11 Remember that proactive means not looking back at a past occurrence Six categories of risks that can impact Be prepared to show/explain in the Quality Program Interview Ensure formal documentation

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