ECRI Patient Safety Organization HFACS and Healthcare

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October 15, 2015 ECRI Patient Safety Organization HFACS and Healthcare Thomas W. Diller, MD, MMM VP System Chief Medical Officer CHRISTUS Health

Learning Objectives Understand the human factors errors for a large health system. Understand lessons learned from the roll out of HFACS across two healthcare systems.

Current Quality Approach Good Quality is Assumed to Equal Safe Patient Care Quality Improvement is Project Based Examples Core Measures, CLABSI, Hand Hygiene, etc. Too Many Things to Do!!! Not Sustainable!!! PI Methods are Inadequate Copy what someone else did and replicate it. Use of simple PI methods (PDCA, Best Practice, etc.). Failure to identify specific causes for performance and fix them. Reactive, rather than Proactive We will be talking about the same errors with the next case. Punitive approach, rather than a system s based approach.

The pursuit of mediocrity is always successful. Karl Albrecht

Event Opportunity Continuum Customer Complaints Patient driven reporting Focus is on immediate mitigation and patient satisfaction Currently difficult to obtain systematic information Occurrences Staff reported events and near misses Identifies areas for process improvement Captured in database, but <10% of events are reported Adverse Events Intense investigation of adverse events Identifies both process and behavioral root causes Malpractice Claims Limited data with several year lag time Generally it is about money, not about process or behavior

Traditional Healthcare Root Cause Analysis Heavily focused on TJC Sentinel Events Focused primarily on actual harm, rather than the risk of harm. Facilitates a Culture of Blame Find out Who did What, rather than Why an event occurred. Flawed Investigation Process Identification of risk events is not optimal. The RCA process is not standardized leading to inconsistent investigation processes and thus findings. The Root Causes are Usually High Level and Not Actionable Events are managed individually without a systematic assessment of risk. We can t improve poor communication. Corrective Actions Do Not Solve the Problems, which then Recur Many corrective actions are relatively weak. Find who is at fault and punish them. Change a policy or process with variable outcomes. More education and training. Try Harder!!!

Error Causation James Reason University of Manchester Organizations create redundant system defense barriers to prevent error. Each defense barrier has its own inherent weakness. Failure or error occurs when the system defense barrier weaknesses accumulate and align. The failures can be due to latent or system failures, or can be due to active or human failures. Thus, usually adverse events have more than one cause. Used with Permission of HPI

Greenville Health System P9 5 Medical Campuses with 1268 Beds GMH = 750 Bed Tertiary Center 2 Community Hospitals Acute Surgical Hospital LTACH > 10,000 Employees > 1,250 Medical Staff 731 Employed / Contracted Physicians $1.5B Net Revenue > 42,000 Discharges > 2.3 M Outpatient Visits ~ 170,000 ETS Visits USC School of Medicine Greenville 7 Residencies / 7 Fellowships > 5,000 Health Care Students

Greenville Health System Process Centralized Risk Management Department Fully trained in methodology (helped develop it) Monitored occurrence reports to identify potential and actual harm events Led investigations and analytics Academic Health System Vice Chairs of Quality all trained in HFACS 2 Vice Chairs of Quality assisted in the development of the methodology Vice Chairs of Quality partnered with Risk Management in the conduction of the investigation and review of findings They were typically accountable for fixes

Human Factors Analysis Classification System (HFACS) Framework Organizational Influences Supervision Resource Management Organizational Climate Organizational Process Inadequate Supervision Inappropriate Planned Operations Failure to Address a Known Problem Supervisory Violation Preconditions for Unsafe Acts Environmental Factors Personnel Factors Conditions of the Operator Physical Environment Technological Environment Communication / Coordination / Planning Fitness for Duty Adverse Mental State Adverse Physiological State Chronic Performance Limitation Unsafe Act Errors Violations Skill-Based Error Decision Error Perceptual Error Routine Exceptional

HFACS 500 Causal Categories Most Common in Adverse Events 1.00 450 400 434 0.90 0.80 350 372 0.70 Number of Cases 300 250 200 150 183 0.60 0.50 0.40 0.30 Percent of Cases 100 50 97 62 0.20 0.10 0 105 coded cases Personnel, Communication, Coordination, Planning Error, Decision Violation, Routine Operator, Adverse Mental State General Causal Category Error, Skill-Based 0.00 P14

HFACS 60 Causal Categories Most Common in Adverse Events 0.35 50 50 0.30 40 0.25 Number of Cases 30 20 36 33 30 26 23 0.20 0.15 0.10 Percent of Cases 10 0.05 0 105 coded cases Environment, Physical Organization, Organizational Climate Environment, Technical Supervision, Inadequate General Causal Category Organization, Organizational Processes Supervision, Inappropriate planned operations 0.00 P15

Organizational Influences

Supervision

Preconditions for Unsafe Acts

Unsafe Acts

Findings Comparison Source Pt. Safety Survey Occurrence Reports HFACS Adverse Mental State No No Yes Communication Yes Yes Yes Errors (Decision / Skill Based) Handoffs and Transitions Organizational Learning Staffing (Resource Management) No No Yes Yes Yes Yes Yes No No Yes +/- +/- Violations No No Yes P20

Findings Comparison Prior to HFACS No preceding cause Lack of sufficient information May have failed to address root causes Non-actionable Root Causes With use of HFACS Actionable Common Causes identified Avoid unintended consequences Identify commonalities across departments/services/units System solutions P21

Lessons Learned HFACS required refining for the healthcare industry Resource intensive and took over two years of adjustments Future refinements should be expedited Retrospective application of HFACS was ineffective Traditional reviews failed to address multiple failure modes or preceding causes Training for key staff (physician leaders and risk managers) is essential Excel database works well Identification of causes is only the beginning; appropriate solutions are essential P22

CHRISTUS Health Catholic Health Care System Top 15 Health System by Size ~25 Hospitals in the U.S. in TX, LA, NM ~11 Hospitals in Mexico / Chile $4.5B in Net Revenues ~30,000 Employees Non-academic, community based

Root Cause Analysis Transition Roll out HFACS as the system-wide standard for the conduction of RCAs. Standardize the process for the conduction of an RCA. Requires substantial education and reinforcement. Focus RCAs on events with both harm and the potential risk of harm. Develop an HFACS database to analyze adverse events / potential events and identify specific opportunities for systemwide and local mitigation of risk. Link performance improvement activity, training including simulation and clinical policies to system-wide risk mitigation.

CHRISTUS Health System Roll Out Process 4 Two day training sessions with Dr. Shappell. Focus on Regional CMOs / CNOs / Quality / Risk / Clinical Education System office key clinical leaders (CCO / CMO / CNO / CQO / CMIO) ~130 key individuals trained Clinical Risk Management Developed a Go Team to assist regions in processes Senior Clinical Leadership Introduced over time as part of a cultural transformation discussion Reinforced including in novel settings capital equipment acquisition

CHRISTUS Health Adverse Event Workflow Potential Risk Event Occurs Actual Risk Event Occurs Front Line Staff Enter Event into Event System Service Recovery / Mitigation Mgr. Reviews Event (24 hrs.) Service Recovery / Mitigation Investigates, Clarifies & CRM Reviews Risk Based Prioritization (48 72 hrs.) High Low Track and Trend Identifies as High Risk Event Identifies as High Risk Event Identifies as High Risk Event Implement Corrective Action Plan Patient Safety Officer Reviews Track and Trend Review Findings Conduct Investigation Assign a Team RCA 2 Process Initiated

CHRISTUS Health Lessons Learned Roll Out Training was spread out over 4 months, needed to be more compact Have regional people come in teams, rather than as individuals Training of senior clinical leaders (CMOs, CNOs) was critical ~12 Adverse Event Investigations To Date All have numerous decision and skill based errors Resource management (staffing) is a concern Fitness for duty (primarily sleep deprivation from more than 1 job)

Questions / Discussion Tom Diller, MD, MMM Thomas.Diller@christushealth.org