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Chapter 9: Patient Safety, Quality and Value
Harry Burke MD PhD
Learning Objectives
After reviewing the presentation, viewers should be able to:
Define safety, quality, near miss, and unsafe action
List the safety and quality factors that justified the clinical implementation of electronic health record systems
Discuss three reasons why the electronic health record is central to safety, quality, and value
List three issues that clinicians have with the current electronic health record systems and discuss how these problems affect safety and quality
Describe a specific electronic patient safety measurement system and a specific electronic safety reporting system
Describe two integrated clinical decision support systems and discuss how they may improve safety and quality
Patient Safety-Related Definitions
Safety: minimization of the risk and occurrence of patient harm events
Harm: inappropriate or avoidable psychological or physical injury to patient and/or family
Adverse Events: “an injury resulting from a medical intervention”
Preventable Adverse Events: “errors that result in an adverse event that are preventable”
Overuse: “the delivery of care of little or no value” e.g. widespread use of antibiotics for viral infections
Underuse: “the failure to deliver appropriate care” e.g. vaccines or cancer screening
Misuse: “the use of certain services in situations where they are not clinically indicated” e.g. MRI for routine low back pain
Introduction
Medical errors are unfortunately common in healthcare, in spite of sophisticated hospitals and well trained clinicians
Often it is breakdowns in protocol and communication, and not individual errors
Technology has potential to reduce medical errors (particularly medication errors) by:
Improving communication between physicians and patients
Improving clinical decision support
Decreasing diagnostic errors
Unfortunately, technology also has the potential to create unique new errors that cause harm
Medical Errors
Errors can be related to diagnosis, treatment and preventive care. Furthermore, medical errors can be errors of commission or omission and fortunately not all errors result in an injury and not all medical errors are preventable
Most common outpatient errors:
Prescribing medications
Getting the correct laboratory test for the correct patient at the correct time
Filing system errors
Dispensing medications and responding to abnormal test results
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While many would argue that treatment errors are the most common category of medical errors, diagnostic errors accounted for the largest percentage of malpractice claims, surpassing treatment errors in one study
Diagnostic errors can result from missed, wrong or delayed diagnoses and are more likely in the outpatient setting. This is somewhat surprising given the fact that US physicians tend to practice “defensive medicine”
Over-diagnosis may also cause medical errors but this has been less well studied
Medical Errors
Unsafe healthcare lowers quality but safe medicine is not always high quality
From the National Academy of Medicine’s perspective, quality is a set of six aspirational goals: medical care should be safe, effective, timely, efficient, patient-centered, and equitable
Value relates to how important something is to use
Cost-effective?
Necessary?
Affect morbidity, mortality or quality of life?
Quality, Safety and Value
Most adverse events result from unsafe actions or inactions by anyone on the healthcare team, including the patient
Missed care is “any aspect of required care that is omitted either in part or in whole or delayed”
Many of the above go unreported
Unsafe Actions
Most near-miss events are not reported. Many are not witnessed
The tendency is the blame the individual, but healthcare is complex and there are often “system errors”
Most safety systems are retrospective; we need to move to be proactive
We need good data, such as the ratio of detected unsafe actions divided by the opportunity of an unsafe action, over a specified time interval
Reporting Unsafe Actions
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Patient Safety Reporting System: event is recorded and if it is a sentinel event, it is investigated.
Most systems are not integrated with the EHR
Root Cause Analysis: common approach to determine the cause of an adverse event. This has limitations
HEDIS measures can help track quality issues
Patient Safety Systems
Current reimbursement models mandate quality measures, e.g. Medicare Patient Safety Monitoring System, now operated by AHRQ. The new system is known as the Quality and Safety Review System. Still labor intensive and manual
Global Trigger Tool: evaluates hospital safety. Said to detect 90% of adverse events. Select 10 discharge records and two reviewers review the chart for any of the 53 “triggers”
Patient Safety Systems
Paper records have multiple disadvantages, as pointed out in the EHR chapter
Expectations have been very high regarding the EHR’s impact on safety, quality and value
Unfortunately, results have been mixed and there has not been a prospective study conducted to prove the EHR’s benefit towards safety and quality
Using the EHR to Improve Safety, Quality and Value
High expectations that CDS that is part of EHRs will improve safety
As per multiple chapters in the textbook, CDS has mixed reviews, in terms of safety and quality
Adverse events regarding CDS, includes ”alert fatigue”
The FDA will regulate software that is related to treatment and decision making
Clinical Decision Support
Results in altered workflow and decreased efficiency. Physicians are staying late to complete notes in the EHR
In an effort to save time physicians may “cut and paste” old histories into the EHR, creating new problems
EHRs may create new safety issues “e-iatrogenesis”
Because of the multiple issues, it is very common to see offices and hospitals change EHRs, not always solving the problem
Clinician’s Issues with EHRs
Roughly 2/3 of EHR data is unstructured (free text) so it is not computable.
While natural language processing (NLP) may help solve this, we are a long ways away from resolution
Multiple open source and commercial NLP programs exist but they require a great deal of time and expertise to match the results a manual chart review would produce
Clinician’s Issues with EHRs
Governmental Organizations Involved with Patient Safety
US Federal Agencies:
Department of Health and Human Services (HHS)
Agency for Healthcare Research and Quality (AHRQ)
Centers for Medicare and Medicaid Services (CMS)
Non-reimbursable complications: (3 examples)
Objects left in a patient during surgery and blood incompatibility
Catheter-associated urinary tract infections
Pressure ulcers (bed sores)
Hospitals must assemble, analyze and trend clinical and administrative data to capture baseline data and measure improvement over time
Health IT-based interventions are expected to assist
Governmental Organizations
Office of the National Coordinator for HIT
Learn: “Increase the quantity and quality of data and knowledge about health IT safety.”
Improve: “Target resources and corrective actions to improve health IT safety and patient safety”
Safety goals will be aligned with meaningful use objectives.
Lead: “Promote a culture of safety related to health IT”
Governmental Organizations
The Food and Drug Administration
MedWatch: posts drug alerts and offers online reporting area
Center for Devices and Radiological Health (CDRH)
Plan to regulate mobile medical applications designed for use on smartphones
State Patient Safety Programs: By 2010, 27 states and the District of Columbia passed legislation or regulation related to hospital reporting of adverse events to a state agency
Meaningful Use Objectives and Potential Impact on Patient Safety
Objective: Use computerized provider order entry (CPOE) for medication, laboratory, and radiology orders directly entered by any licensed healthcare professional who can enter orders into the medical record per state, local, and professional guidelines
Objective: Use clinical decision support to improve performance on high-priority health conditions
Meaningful Use Objectives and Potential Impact on Patient Safety
Objective: Automatically track medications from order to administration using assistive technologies in conjunction with an electronic medication administration record (eMAR)
Objective: Generate and transmit discharge prescriptions electronically (eRx)
Non-Governmental Organizations and Patient Safety
National Patient Safety Foundation (NPSF) Goals:
Identifying and creating a core body of knowledge
Identifying pathways to apply the knowledge
Developing and enhancing the culture of receptivity to patient safety
Raising public awareness and fostering communication around patient safety
National Academy of Medicine (was the Institute of Medicine or IOM)
Institute of Medicine (IOM) Recommendations
Congress should create a Center for Patient Safety within the Agency for Healthcare Research and Quality
A nationwide reporting system for medical errors should be established
Volunteer reporting should be encouraged
Congress should create legislation to protect internal peer review of medical errors
Performance standards and expectations by healthcare organizations should include patient safety
FDA should focus more attention on drug safety
Healthcare organizations and providers should make patient safety a priority goal
Healthcare organizations should implement known medication safety policies
IOM Report - 2003
Patient safety must be linked to medical quality
A new healthcare system must be developed that will prevent medical errors in the first place
New methods must be developed to acquire, study and share error prevention among physicians, particularly at the point of care
The IOM recommended specific data standards so patient safety-related information can be recorded, shared and analyzed
IOM Report - 2011
Report focused exclusively on health IT and patient safety and quality
Publish an “action and surveillance plan”
Push health IT vendors to support the free exchange of information about health IT experiences and issues
Public and private sectors should make comparative user experiences public
Health IT Safety Council should assess and monitor safe use of health IT
Specify quality and risk management processes health IT vendors must adopt
Establish an independent federal entity to investigate patient safety deaths, serious injuries, or potentially unsafe conditions associated with health IT
Support cross-disciplinary research toward the use of health IT as part of a learning system
Non-Governmental Organizations and Patient Safety
The National Quality Forum
The Joint Commission:
Published the 2018 National Patient Safety Goals
They also published an alert about the potential for HIT to create new patient safety issues
LeapFrog Group
HealthGrades
Institute for Safe Medication Practice (IMSP)
HealthGrades 2017 Patient Safety Excellence Awards
Award recognizes hospitals with the lowest occurrences of 14 preventable patient safety events, placing the hospitals in the top 10% in the nation for patient safety
This organization reviews the data from inpatient Medicare and Medicaid cases each year and rates hospitals, in terms of patient safety
They estimate that the top ranking hospitals represent, on average, a 43% lower risk of a patient safety adverse event compared to the lowest ranking hospitals
Quality Care Finder
Allows consumers to review quality metrics e.g. morbidity and mortality making decisions
Technologies with Potential to Decrease Medication Errors
Computerized provider order entry (CPOE) Benefits:
Improved handwriting identification
Reduced time to arrive in the pharmacy
Fewer errors related to similar drug names
Easier to integrate with other IT systems
Easier to link to drug-drug interactions
More likely to identify the prescriber
Available for immediate analysis
Can link to clinical decision support to recommend drugs of choice
Jury still out on actual reduction of serious ADEs
Technologies with Potential to Decrease Medication Errors
Health Information Exchange (HIE):
Improve patient safety by better communication between disparate healthcare participants
Automated Dispensing Cabinets (ADCs): like ATM machines for medications on a ward
Home Electronic Medication Management System: home dispensing, particularly for the elderly or non-compliant patient
Pharmacy Dispensing Robots: bottles are filled automatically
Electronic Medication Administration Record (eMAR): electronic record of medications that is integrated with the EHR and pharmacy
Intravenous (IV) Infusion Pumps: regulate IV drug dosing accurately
Bar Coding Medication Administration: the patient, drug and nurse all have a barcoded identity
These must all match for the drug to be given without any alerts
Bar codes are inexpensive but the software and other components are expensive
Some healthcare systems have shown a significant reduction in medication administrative errors, but many of these were minor and would not have resulted in serious harm
Technologies with Potential to Decrease Medication Errors
Technologies with Potential to Decrease Medication Errors
Medication Reconciliation
When patients transition from hospital-to-hospital, from physician-to physician or from floor-to-floor, medication errors are more likely to occur
Joint Commission mandated hospitals must reconcile a list of patient medications on admission, transfer and discharge
Task may be facilitated with EHR but still confusion may exist if there are multiple physicians, multiple pharmacies, poor compliance or dementia
Barriers to Improving Patient Safety through Technology
Organizational: health systems leadership must develop a strong “culture of safety”
Financial: Cost for multiple sophisticated HIT systems is considerable
Error reporting: is voluntary and inadequate and usually “after the fact”
Unintended Consequences
Technology may reduce medical errors but create new ones:
Medical alarm fatigue
Infusion Pump errors
Distractions related to mobile devices
Electronic health records: data can be missing and/or incorrect, there can be typographical entry errors, and older information is sometimes copied and pasted into the current record
Patient safety continues to be an ongoing problem with too many medical errors reported yearly
Multiple organizations are reporting patient safety data transparently to hopefully support change
There is a great expectation that HIT will improve patient quality which in turn will decrease medical errors
There is some evidence that clinical decision support reduces errors, but studies overall are mixed
Leadership must establish a “culture of safety” to effectively achieve improvement in patient safety
Conclusions