Patient Safety Achieving a New Standard for Care (2004) / Chapter Skim
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6 Adverse Event Analysis
6 Adverse Event Analysis
Pages 200-225
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From page 200... ...
Even if larger numbers of adverse events were detected, the information would be of limited value because of differing definitions of adverse events and varying data collection and analysis methods. There are many ways to detect adverse events -- through reporting systems, document review, automated surveillance of clinical data, and monitoring of patient progress.
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From page 201... ...
Ulti mately, an integrated approach, using patient safety data standards, will evolve, with electronic health record systems providing decision support at the point of care, preventing adverse events to the extent possible and facilitating the collection of reporting data when adverse events do occur. Use of adverse event systems is also aimed at identifying improved health care processes through the analysis of adverse event data.
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From page 202... ...
The focus is on the analysis of a subset of adverse events to determine root causes and identify improvements in care processes, ultimately improving patient safety.
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From page 203... ...
However, a number of epidemiological studies have examined the relative strengths and weaknesses of voluntary reporting, retrospective chart review, and automated surveillance for detection of adverse drug events (ADEs)
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From page 204... ...
For example, in searching anesthesia records for problems arising from the management of diabetes in the peri-operative period, large amounts of redundant information might be picked up as a result of patients having iatrogenic diabetes in the peri-operative period. In conclusion, for ADEs, and probably for other types of adverse events as well, the three approaches to event detection reviewed -- automated surveillance, chart review, and voluntary reporting -- complement each other, with voluntary reporting being most effective at identifying potential adverse events or near misses (see Chapter 7)
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From page 205... ...
. More recently, chart review has begun to use the rules incorporated in automated surveillance techniques.
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From page 206... ...
for the diuretic drug group. Monitoring of the Progress of Patients The progress of patients can be monitored as they pass through the care process both to anticipate and protect against circumstances that could lead to adverse events and to implement corrective actions based on analysis of patient injuries discovered in the past.
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From page 207... ...
/mL Serum bilirubin >10 milligrams/deciliter Serum cyclosporine >500 µg/L Serum potassium >6.5 millimoles/L Blood eosinophils >6 percent Receiving kaopectate Receiving loperamide Serum n-acetyl procainamide >20 µg/mL Serum phenytoin results >20 µg/mL Serum phenobarbital results >45 µg/mL Receiving prednisone AND diphenhydramine Serum procainamide >10 µg/mL Serum aspartate amino transferase >150 U/L AND no prior result >150 U/L Serum theophylline >20 µg/mL Serum valproate >120 µg/mL Serum quinidine >5 µg/mL Serum alanine aminotransferase >150 U/L AND no result >150 U/L in last 7 days SOURCE: Honigman et al., 2001. this approach is monitoring the progress of individual patients and groups of patients with the same condition as they pass through the care process using measures for assessing the quality of care given, such as those of the Diabetes Quality Improvement Project (DQIP)
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From page 208... ...
management, lipid management, urine protein testing, eye examination, foot examination, blood pressure management, and smoking cessation. The set for quality improvement includes measures in these seven areas and in two additional areas -- influenza immunization and aspirin use.
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From page 209... ...
One procedure is to determine the extent of therapeutic duplication between the newly prescribed medica TABLE 6-1 Data Requirements for the Definition of an Adult Diabetes Patient Definition Data Requirements Those who were dispensed insulin and/or oral • Insulin medication hypoglycemics/antihypoglycemics • Oral hypoglycemic medication • Date of ambulatory encounter OR • Diagnosis of ambulatory encounter • Medication prescribed at ambulatory Those who had two face-to-face encounters in encounter an ambulatory setting or non-acute inpatient • Date of inpatient encounter setting or one face-to-face encounter in an • Diagnosis at inpatient encounter inpatient or emergency room setting with • Date of ER encounter a diagnosis of diabetes • Patient age NOTE: Patients with gestational diabetes excluded. SOURCE: American Medical Association, Joint Commission on Accreditation of Healthcare Organizations, National Committee for Quality Assurance, 2001.
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From page 210... ...
cholesterol, and triglycerides by range Urine protein testing Per patient: • Any test for microalbuminuria received • If no urinalysis or urinalysis with negative or trace urine protein, a microalbumin test received Across all patients: • Percent of patients receiving any test for microalbuminuria • Percent of patients with no urinalysis or urinalysis with negative or trace urine protein who received a test for microalbumin Eye examination Per patient: • Dilated retinal eye exam performed by an ophthalmologist or optometrist • Funduscopic photo with interpretation by an ophthalmologist or optometrist Across all patients: • Percent of patients receiving a dilated retinal eye exam by an ophthalmologist or optometrist • Percent of patients receiving funduscopic photo with interpretation by an ophthalmologist or optometrist
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From page 211... ...
• Date of glycohemoglobin test • Percent of patients with most recent • HbA1C level HbA1C level >9.0% • Percent of patients receiving at least one • Lipid profile test low-density lipoprotein cholesterol (LDL-C) test • Date of lipid profile test • Percent of patients with most recent LDL-C level • Result of lipid profile test (total <130 milligrams/deciliter cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides)
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From page 212... ...
pulse exam) Across all patients: • Percent of eligible patients receiving at least one complete foot exam (visual inspection, sensory exam with monofilament, and pulse exam)
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From page 213... ...
None • Influenza immunization • Date influenza immunization given • Influenza immunization refused • Date influenza immunization refused • Allergy to eggs • Percent of patients with most recent blood • Blood pressure measurement pressure <140/90 millimeters/hemoglobin • Date of blood pressure measurement • Most recent blood pressure level None • Patient age • Aspirin therapy • Aspirin dose • Aspirin contraindications/allergies • Percent of patients whose smoking status was • Smoking status ascertained and documented annually • Date smoking status documented • Counseling offered or recommended • Pharmacologic therapy offered or recommended
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From page 214... ...
, diagnoses, patient age, weight, laboratory results, and contrast media used in radiology. Implications for Data Standards The various approaches to adverse event detection discussed above demonstrate that it is not possible to simply identify a small set of clinical data elements specifically for adverse event detection, especially when addressing potential injuries due to errors of omission as well as injuries due to errors of commission.
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From page 215... ...
ANALYSIS OF ADVERSE EVENT SYSTEMS Functional Requirements Understanding an Adverse Event An outside physician calls hospital administration after one of her patients de velops a near-fatal adverse reaction thought to be secondary to a drug–drug reaction to a medication prescribed in an emergency department 2 days previ ously. The patient safety team is assembled and after some careful detective work determines that the cause of the problem was that house staff rotating into the hospital from outside institutions were trained inadequately in use of the hospital electronic health record.
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From page 216... ...
One hallmark of effective analysis of adverse events is that it leads to system changes that inherently make it easier for those working in a health care delivery environment to do the job right, as opposed to a constant emphasis on more education or closer oversight -- both second-hand markers for blame. Since much of health care is organized around the convenience of clinicians, however, it is important to note that interventions that alter the sequence of work flow are more challenging to implement.
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From page 217... ...
Definitions of Terms An examination of the literature on patient safety raises many questions. Paramount among these is the problem of definitions of terms, with differing definitions of errors, adverse events, and near misses being used from one publication to another.
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From page 218... ...
For example, the appropriate definitions might appear on a computer screen when the data are being collected. Minimum Datasets To specify definitions and potential uses of terms to be included in an adverse event system, it is necessary to have minimum data requirements for the system.
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From page 219... ...
. Using automated surveillance together with other detection methods will lead to the detection of a much greater number of adverse events that might warrant such an analysis than would otherwise be possible.
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From page 220... ...
• Results Once a root-cause analysis has been completed, its results, including the following, should be fully documented and acted upon: – Failed (and successful) defenses and recoveries for the patient – Outcome for the patient – Lessons learned and ways to improve patient safety Here there is an important difference between adverse events and near misses.
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From page 221... ...
, facilitates auditing, and improves the data's external validity. Integrating Data Across Systems and Settings Clearly, one goal of adverse event systems is to allow aggregate reporting of events for purposes of both assessing known problems before and after interventions and detecting new problems.
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From page 222... ...
Definitions of Core Constructs As noted above, a fundamental and nettlesome issue has been defining the key concepts relating to patient safety -- adverse events and near misses. The failure to use standard definitions for these core concepts has made comparisons among institutions challenging at best.
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From page 223... ...
• Analyzing the redesigned process to identify known failure points and high-risk events for each step, paying particular attention to the hazards that may have been introduced at points where the redesigned portions of the care process intersect with the original portions. • Identifying for the redesigned care process the reports/data needed to monitor the key clinical performance variables and patient outcomes and to collect information on failures and near failures (adverse events and near misses)
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2003. Detecting adverse events using information technology.
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From page 225... ...
New York, NY: MilBank Memorial Fund/ECRI. National Diabetes Quality Improvement Alliance.
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