Statutes, codes, and regulations
Delaware Administrative Code
Title 16 - Health and SafetyDepartment of Health and Social ServicesDivision of Public HealthEmergency Medical Services (EMS)
Stroke System Regulation
Section 4306-8.0 - State of Delaware Stroke System Performance Improvement Plan

16 Del. Admin. Code § 4306-8.0

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Current through Register Vol. 28, No. 7, January 1, 2025
Section 4306-8.0 - State of Delaware Stroke System Performance Improvement Plan
8.1 Purpose. The State of Delaware Stroke System is committed to the provision of optimal care for all injured persons. To attain this goal, DPH coordinates all medical services provided to stroke patients based on national standards for stroke care as set forth by TJC, Disease-Specific Care Certification Review Process Guide, 2022, and subsequent revisions and the American Heart Association's Get With The Guidelines Stroke Registry. This Performance Improvement Plan seeks to "improv[e] stroke care by promoting consistent adherence to the latest scientific treatment guidelines, [as evidenced by] numerous published studies demonstrating the program's success in achieving measurable patient outcome improvements." (https://www.heart.org/en/professional/quality-improvement/get-with-the-guidelines/get-with-the-guidelines-stroke)
8.2 Objectives
8.2.1 Based on national standards for stroke care quality improvement outlined in TJC's Disease-Specific Care Certification Review Process Guide, 2022, and subsequent revisions, the Stroke System's Performance Improvement Plan describes the framework for use in designing, measuring, assessing, and improving the Delaware Stroke System's organization, functions, and services.
8.2.2 The plan promotes performance improvement through education, facilitation of inter-hospital and intra-hospital communication, and systems coordination. It integrates all prehospital, medical staff, nursing, ancillary services, and operational performance improvement activities through systematic monitoring and evaluation of the appropriateness of patient care, the measurement of outcomes, and the identification of opportunities for improvement.
8.2.3 Improvement is accomplished by a collaborative approach with the appropriate facilities, services, and disciplines involved, utilizing the following objectives:
8.2.3.1 Continual systematic measurement to understand and maintain the stability of systems and processes;
8.2.3.2 Measurement of patient and systems outcomes to help determine priorities for improving systems and processes; and
8.2.3.3 Assessment of system competence and performance.
8.3 Authority
8.3.1 The care of the stroke patient is monitored and evaluated at both the facility and System levels. DPH has the authority for system data collection, review, and most importantly the authority to recommend corrective action in all aspects of stroke care throughout the continuum from onset to rehabilitation. DPH will guide, as needed, individual stroke centers in the development and implementation of their Stroke Performance Improvement Programs.
8.3.2 Maintenance of patient confidentiality is the joint responsibility of evaluators at the State and facility levels.
8.4 Prehospital Evaluation
8.4.1 Objective
8.4.1.1 DPH shall work with the Fire Prevention Commission to address improvements regarding prehospital care of the stroke patient. The AHA's GWTG and the current "State of Delaware, Department of Health and Social Services, DPH, Office of Emergency Medical Services, Statewide Standard Treatment Protocols, Guidelines, Policies, and Paramedic Standing Orders" and "Statewide Standard Treatment Protocols and Basic Life Support Standing Orders" will provide a basis for prehospital stroke care evaluation.
8.4.1.2 Evaluation
8.4.1.2.1 There will be an ongoing evaluation of all aspects of stroke care from the receipt of the call at central dispatch through the patient's care at the stroke center.
8.4.1.2.2 Evaluation will document the quality of care provided and compliance with protocols. Areas in need of improvement will be identified. Major areas of review are as follows:
8.4.1.2.2.1 Completion of assessment with VAN/electrocardiogram/blood glucose/Last Known Well which is hours elapsed since a patient was known to be at their baseline, without signs and symptoms of their current stroke activity;
8.4.1.2.2.2 Scene time;
8.4.1.2.2.3 Transport decisions;
8.4.1.2.2.4 Transport to the appropriate facility;
8.4.1.2.2.5 Under/over triage with VAN;
8.4.1.2.2.6 Documentation; and
8.4.1.2.2.7 Data collection.
8.4.2 Delaware will follow national standards for prehospital data collection. DPH will collaborate with the State Fire Prevention Commission to determine the minimum data sets to be collected by BLS and ALS providers. Data used for the evaluation of prehospital care must be consistent with the design of the Delaware Stroke Registry, as collected by the medical facilities and analyzed by DPH.
8.4.3 Performance improvement indicators will be determined by the Stroke System QE Committee based on Delaware prehospital protocols and national and Delaware standards of care.
8.4.4 Performance Improvement
8.4.4.1 A completed prehospital patient care record must be provided to the receiving facility for inclusion in the patient's emergency room or hospital medical record. Facilities and prehospital providers are strongly encouraged to establish a mechanism for the exchange of information, including the provision of feedback to prehospital providers on triage decisions made. Additionally, the hospital's stroke registrar will include this record's data in the facility's stroke registry for outcome evaluation.
8.4.4.2 A performance improvement program model shall be developed by DPH or its designee for the use of BLS and ALS agencies. Recommendations for changes in educational curricula, patient care protocols, etc., shall be based on analysis of information obtained through the prehospital evaluation process. DPH shall also develop a mechanism for prehospital providers to have input into quality assurance issues, including the identification of educational needs and methods of addressing them.
8.5 Stroke Center Evaluation
8.5.1 All recognized stroke facilities will design a performance improvement plan that meets the standards and requirements established by TJC or other nationally recognized accreditation body. Hospital performance improvement plans will be verified during site surveys and quality improvement visits.
8.5.2 Design. When new processes or systems are developed within an institution, the design will be based on the following:
8.5.2.1 Up-to-date sources of information about designing processes and systems including practice guidelines, clinical pathways, professional standards, and regulatory standards;
8.5.2.2 The needs and expectations of internal and external consumers; and
8.5.2.3 The performance of the processes and systems and their outcomes including internal and external (benchmarking) comparison data.
8.5.3 Measure. Quality indicators (audit filters) will be based on nationally recognized guidelines set forth by TJC. They are established to evaluate the process or outcome of the care or services provided or to determine the level of performance of existing processes and the outcomes resulting from these processes. Data collection and measurement will be systematic, related to relevant standards of care, and prioritized according to high volume, high risk, or problem-prone areas. In addition, the needs, expectations, and feedback from patients and their families, employees, results of ongoing monitoring activities (e.g., infection control), safety of the patient care environment, utilization, and risk management findings will be included.
8.5.4 Data collection will be designed to:
8.5.4.1 Assess new or existing processes;
8.5.4.2 Measure the level of performance and stability of important existing processes;
8.5.4.3 Set performance improvement priorities;
8.5.4.4 Establish benchmarks of performance to identify potential opportunities for improvement;
8.5.4.5 Identify patterns and trends that may require focused attention;
8.5.4.6 Provide comparative performance data to use for performance improvements; and
8.5.4.7 Evaluate whether changes have improved the processes.
8.5.5 Quality indicators (audit filters) may:
8.5.5.1 Measure events or phenomena that are expected to occur at some level of frequency:
8.5.5.2 Relate data about either a process or an outcome;
8.5.5.3 Relate data about occurrences that are either desirable or undesirable;
8.5.5.4 Relate data that guide the Stroke Program in improving norms of performance instead of focusing exclusively on censoring or eliminating individual outliers; and
8.5.5.5 Identify serious events that may trigger an opportunity for improvement and require further data collection.
8.5.6 Focused audits will be used to periodically examine the process of care as recommended by TJC and may include the following:
8.5.6.1 Noncompliance with hospital criteria for stroke center designation
8.5.6.2 The absence of documentation of required information/patient assessment findings on stroke care records
8.5.7 Assessment
8.5.7.1 After collection, the data will be analyzed to determine the following:
8.5.7.1.1 If the design specifications for new processes were met;
8.5.7.1.2 The level of performance and stability of existing processes;
8.5.7.1.3 Priorities for possible improvement of existing processes;
8.5.7.1.4 Actions and strategies to improve the performance of processes; and
8.5.7.1.5 Whether changes in the processes resulted in improvement.
8.5.7.2 This assessment will be accomplished using statistical quality control techniques and tools, comparative benchmarking data (TJC, GWTG, and others), a review of the stroke program's processes and outcomes over time, and other reference material as appropriate. Intensive assessment will be used when measurement indicates that potential performance or system-related opportunities for improvement exist, a single serious event occurs, the control limits are met, or when undesirable variation in performance has occurred or is occurring.
8.5.7.3 The assessment process will be interdisciplinary and interdepartmental depending upon the process or outcome under review.
8.5.8 Improvement. When an opportunity for improvement is identified or when the measurement of an existing process identifies the need to redesign a process, a systematic approach such as the Find, Organize, Clarify, Understand, Select and Plan, Do, Check, Act (FOCUS-PDCA) Six Sigma Model, will be implemented. This model is the ongoing process used to promote continuous improvement as described below:
8.5.8.1 Find (Identify) process to improve.
8.5.8.1.1 Develop an opportunity statement; and
8.5.8.1.2 Identify the process.
8.5.8.2 Organize a team that knows the process.
8.5.8.2.1 Identify employees who work closest with the process; and
8.5.8.2.2 Identify internal/external consumers and their expectations.
8.5.8.3 Clarify current knowledge of the process.
8.5.8.3.1 Identify sound areas of the process;
8.5.8.3.2 Determine if team members are appropriate to assess the process;
8.5.8.3.3 Identify the process flow; and
8.5.8.3.4 Identify problems/redundancies that can be eliminated to make the flow more efficient.
8.5.8.4 Understand the cause of process variation.
8.5.8.4.1 Identify variation in the process;
8.5.8.4.2 Identify measurable process characteristics;
8.5.8.4.3 Identify if the variation has a common or unique cause; and
8.5.8.4.4 Identify the effect the variation has on other hospital systems.
8.5.8.5 Select an improvement strategy.
8.5.8.5.1 Determine what changes can be made to improve the process; and
8.5.8.5.2 Start a description of the process to be improved.
8.5.8.6 Plan the improvement and data collection
8.5.8.6.1 Identify what improvements are to be made and in what order;
8.5.8.6.2 Assign responsibility for making the change;
8.5.8.6.3 Determine when the change will be effective; and
8.5.8.6.4 Determine what data will be collected to measure changes.
8.5.8.7 Do (put plan into action) the Improvement.
8.5.8.7.1 Initiate the change (pilot study period); and
8.5.8.7.2 Collect data.
8.5.8.8 Check the results.
8.5.8.8.1 Analyze the results of the data collection; and
8.5.8.8.2 Draw conclusions.
8.5.8.9 Act to sustain gains
8.5.8.9.1 Standardize the change;
8.5.8.9.2 Determine ongoing measurement of the process and reevaluation of implemented changes (effectiveness monitored for a minimum of 3 months following corrective action);
8.5.8.9.3 Policy and procedure development/revision; and
8.5.8.9.4 Education and communication of new process.
8.5.9 Following the identification and documentation of a specific problem in patient care or system performance by the peer-review process, corrective action is taken through 1 of the following mechanisms:
8.5.9.1 Change existing policies and procedures that govern or define the standard of care.
8.5.9.2 Provide professional education. Cases may be selected for discussion at the stroke service conferences; deficits in knowledge can be addressed through education of the whole group of providers or specific providers.
8.5.9.3 Provide counseling. Specific cases are reviewed by the Director of Stroke, chief of the service, or the supervisor, with the individual.
8.5.9.4 Provide credentials. Report information from quality improvement activities through the institution's performance improvement system for consideration at the time of credentialing, delineation of privileges, or evaluation.
8.6 Stroke System Evaluation
8.6.1 Stroke System evaluation encompasses the entire scope of care provided to stroke patients within the State of Delaware from stroke onset through rehabilitation.
8.6.2 DPH Responsibilities
8.6.2.1 Implement and monitor the State Stroke System Quality Improvement Program; and
8.6.2.2 Appoint a qualified Stroke System Medical Advisor and SSC Chairperson from candidates recommended by the SSC members. Terms of Service:
8.6.2.2.1 Terms of office are 3 years, and
8.6.2.2.2 Successive terms are permissible.
8.6.3 Stroke System Registry Coordinator Responsibilities
8.6.3.1 Review Stroke Registry data submitted for completeness.
8.6.3.2 Provide data for the QE Committee meetings, upon request.
8.6.3.3 Complete approved data requests from GWTG.
8.6.3.4 Function as staff for QE Committee.
8.6.4 Delaware State Stroke System QE Committee
8.6.4.1 The Stroke System QE Committee is a subcommittee of the Stroke System Committee.
8.6.4.2 Membership consists of representatives from each component of the statewide Stroke System.
8.6.4.3 Responsibilities of the QE Committee
8.6.4.3.1 The Delaware Stroke System QE Committee is charged with providing recommendations, guidance, and technical assistance to DPH in its ongoing evaluation of the Delaware Stroke System. Specific functions may include the following:
8.6.4.3.1.1 Assist the Stroke System Registry Coordinator in the supervision of the State Stroke Registry.
8.6.4.3.1.2 Assess stroke care standards and recommend actions for the development and implementation of statewide policies and procedures that guide and support the provision of stroke care or services.
8.6.4.3.1.3 Assess resources needed to support and sustain the Delaware State Stroke System.
8.6.4.3.1.4 Evaluate the coordination and integration of prehospital, inter-hospital, intra-hospital, and ancillary services.
8.6.4.3.1.5 Monitor the incidence of adverse outcomes regularly with comparison to regional and national norms.
8.6.4.3.1.6 Recommend action for identified problems or opportunities for improvement in patient care services.
8.6.4.3.1.7 Sponsor ongoing education regarding TJC and GWTG standards and provide a multidisciplinary educational forum for presentation and discussion of interesting, difficult, or controversial stroke patient management cases.
8.6.4.3.1.8 Evaluate the effectiveness of actions taken and determine follow-up.
8.6.4.3.1.9 Meet a minimum of 4 times per year, and as determined by the Committee or DPH.
8.6.4.3.1.10 Assess other sources of data to combine into a comprehensive database for evaluation of the continuum of stroke care in the State of Delaware.
8.6.4.3.1.11 Develop operational guidelines for the Committee's functioning.
8.6.4.3.1.12 Perform any other function deemed necessary by DPH.
8.6.4.3.2 Review of major areas within the Stroke System, including:
8.6.4.3.2.1 Triage;
8.6.4.3.2.2 Interfacility transfer;
8.6.4.3.2.3 Facility performance;
8.6.4.3.2.4 Impact of system;
8.6.4.3.2.5 Integrity of Stroke Registry data; and
8.6.4.3.2.6 Prevention trends.
8.7 Delaware State Stroke Registry
8.7.1 Patient Criteria. To generate consistent statewide data, all patients with an International Classification of Diseases (ICD) code included in TJC reporting requirements must be included in the stroke registry (GWTG).
8.7.2 Data Set
8.7.2.1 Facilities will abstract the required data as soon as possible, but no more than 90 days after the close of each quarter.
8.7.2.2 Data collected from contributing acute care facilities will form the State's stroke patient registry. System registry data will then be used in the process of formulating System reports, and for System quality improvement, data linkage, and research/prevention activities.
8.7.2.3 The Delaware State Stroke Registry data set is defined by GWTG.
8.7.3 Hospital Participation
8.7.3.1 All acute care facilities in Delaware that receive stroke patients will be required to contribute to the State stroke registry program by abstracting data into GWTG.
8.7.3.2 Each contributing facility will be responsible for the staff and resources to ensure timely and accurate stroke data abstraction.
8.7.3.3 Both the individual contributing facilities and the State will be responsible for data integrity and confidentiality.
8.8 Oversight. The Emergency Medical Services Office within DPH receives at least semi-annual reports of the Stroke System's Evaluation Committee activities. Minutes of each meeting will be forwarded to the System of Care Coordinator in a timely manner.
8.9 Confidentiality. As used in this section, "records" means the recordings of interviews and all oral or written reports, statements, minutes, memoranda, charts, data, statistics, and other documentation generated by the Evaluation Committee, its subcommittees, and the State Stroke Registry for the stated purpose of stroke system medical review or quality care review and audit.
8.9.1 All quality management proceedings shall be confidential. Records of the State Stroke Evaluation Committee, its subcommittees, the Delaware State Stroke Registry, and attendees at meetings held for stated purposes of stroke system medical review or quality care review and audit shall be confidential and privileged and shall be protected from direct or indirect means of discovery, subpoena, or admission into evidence in any judicial or administrative proceeding.
8.9.2 All studies, reports, and minutes will include only the patient stroke registry number with all other identifying information encoded or kept in locked files. Access to qualified researchers may be granted based on state, federal, and municipal statutes, bylaws, rules, regulations, and policies. All meeting attendees will be required to sign confidentiality statements. Any documented breach of confidentiality will be referred to DPH for appropriate action.
8.10 Biennial Review. This plan is reviewed at least biennially by DPH and the QE Committee.

16 Del. Admin. Code § 4306-8.0

28 DE Reg. 390 (11/1/2024) (Final)