Adverse Events and Medical Errors Dennis Tsilimingras, M.D., M.P.H.

Adverse Events and Medical Errors
Dennis Tsilimingras, M.D., M.P.H.
Director, Center on Patient Safety
Assistant Professor of Family Medicine & Rural Health
The Florida State University College of Medicine
Objectives
(1) To become familiar with common patient safety definitions.
(2) To become familiar with the theory for the occurrence of
adverse events/medical errors in the healthcare system.
(3) To become familiar with major inpatient studies and reports
on adverse events/medical errors.
(4) To become familiar with major postdischarge studies on
adverse events/medical errors.
(5) To become familiar with the common types of adverse
events.
(6) To become familiar with recommendation that may prevent
adverse events/medical errors in the healthcare system.
Outline
• Patient safety definitions
• Discontinuities in care (theory for the occurrence of
adverse events/medical errors)
• Major inpatient adverse event/medical error studies
• Common types of inpatient adverse events/medical errors
• Institute of Medicine and AHRQ reports on patient safety
• Post-discharge adverse event studies
• Common types of postdischarge adverse events
• Diagnostic errors/mis-diagnoses
• Clinical scenarios of inpatient and post-discharge adverse
events/medical errors
• Recommendations for improvement
• Conclusions
Patient Safety Definitions
• Medical error, defined as the failure of a planned
action to be completed as intended or the use of a
wrong plan to achieve an aim.
• Adverse event, defined as an injury caused by
medical management rather than by the underlying
disease or condition of the patient.
• Preventable adverse event, defined as an adverse
event injury that could have been avoided as a result
of an error or system design flaw.
Patient Safety Definitions
• Ameliorable adverse event, defined as an injury
whose severity could have been substantially
reduced if different actions or procedures had been
performed or followed.
• Negligence, defined as whether the care provided
failed to meet the standard of care reasonably
expected of an average physician qualified to take
care of the patient in question.
• Error of omission, occurs when a necessary
procedure or intervention failed to be performed
leading to morbidity or mortality to the patient
involved.
Patient Safety Definitions
• Most medical errors do not result in medical injury,
though some do, and these are termed preventable
adverse events.
• Many adverse events are neither preventable nor
ameliorable.
Figure 1: Relationship between medical errors, potential adverse
events, and adverse events.
Errors that did not cause harm and
have no potential to cause harm
Non-preventable,
Non-ameliorable
Adverse Events
Medical Errors
Potential
Adverse
Events
Errors that have
the potential to
cause harm
Adverse
Events
Preventable or
Ameliorable
Adverse Events
Miller MR, et al. Medication errors in pediatric care: a systematic review of epidemiology and an evaluation of evidence
supporting reduction strategy recommendations. Qual Saf Health Care. 2007;16:116-126.
Patient Safety Definitions
• For example, an unavoidable adverse event can
occur from an unknown drug reaction in a patient
who received the appropriate administration of a
particular drug for the first time.
• However, if a drug reaction occurred in a patient who
knowingly had a previous allergic reaction to that
particular drug, the adverse event would be
considered preventable, and might be considered
negligent.
The patient developed a hoarse voice after
being discharged with a prescription for an
inhaled steroid. The patient did not recall
being taught about gargling or rinsing after
using the inhaled steroid.
50%
This scenario describes:
30%
1. Adverse Event
2. Error of omission
3. Medical error
20%
1
2
3
A patient with no known drug allergies has an
allergic reaction to a drug administered.
This scenario describes:
81%
1. A preventable adverse event
2. An ameliorable adverse event
3. An unavoidable adverse event
6%
1
13%
2
3
A diabetic patient had the wrong foot
amputated.
This scenario describes:
89%
1. Preventable adverse event
2. Ameliorable adverse event
3. Unavoidable adverse event
9%
1
2
2%
3
Most medical errors result in
medical injury.
98%
1. True
2. False
2%
1
2
Discontinuities in Care
• Discontinuities or gaps in care (the theory for the
occurrence of adverse events/medical errors):
-occur in complex systems, such as the healthcare
system, that involves the interaction of numerous
health professionals.
-health professionals are faced with the responsibility
to deliver optimal care within a limited time frame, to
focus on cost-saving efforts, and to develop new
skills and judgment abilities for advances in medical
knowledge and technology.
Discontinuities in Care
-all of these factors create pressures for healthcare
professionals to efficiently deliver care and are major
contributors in raising the level of risk for medical
errors and adverse events.
-such complexity within a system increases the
potential for error when multiple and expedient handoffs are necessary throughout the system.
-during hand-offs is when the system is most
vulnerable for gaps that result between multiple
tasks along the continuum of care.
Figure 2: Conceptual Model for the Occurrence of
Medical Errors/Adverse Events
Numerous
Professionals
___________________________________________
[
Discontinuities in Care
Poor Information
Transfer
[
Faulty
Communication
Hand-Offs
During a
Hospitalization
]
]
and/or After Hospital Discharge
Ambulatory Care
Medical Errors
Adverse events
Discontinuities in Care
-Discontinuities in care arise mainly from poor
information transfer and faulty communication
that often take place:
(1) between inpatient and outpatient pharmacies
(increased risk of overmedication & harmful drug
interactions).
(2) as a result of unstructured cross-coverage
physician sign-outs (patient’s medical condition,
laboratory data, resuscitation status, problem list,
medication allergies, and follow-ups).
Discontinuities in Care
(3) as a result of unstructured physician discharge
summaries (invite inaccuracies & significant
delays in transmitting pertinent info to outpatient
providers; structured, database-generated
discharge summaries).
(4) inadequate discharge planning process (early home
return, assessment of plans & needs for discharge
by a nurse at admission, and early involvement of a
social worker & home nurse if indicated).
(5) inadequate patient notification and follow-up of
abnormal laboratory test results.
During a Hospitalization
• Anesthesiology, the 1st medical specialty to
investigate medical errors/adverse events in
the mid-80’s:
-improved mortality rates in the operating
room:
1 death/10,000 patients (mid-80’s)
to
1 death/400,000 patients (present)
Orkin FK. Con: Is pulse oximetry still worthwhile? J Clin Monit. 1998;14:369-372.
During a Hospitalization
(Adults)
• Harvard Medical Practice Study (NEJM 1991):
-landmark study on medical errors/adverse events.
-fueled the 1st Institute of Medicine report on patient
safety, “To Err Is Human”.
-1st patient safety study to randomly select a large number
of records involving many institutions and develop more
current and more reliable estimates for the incidence of
adverse events and negligence.
-sampled 30,000 patients from 51 institutions in New York
State using 1984 data.
During a Hospitalization
Results of the Harvard Medical Practice Study:
-adverse events related to treatment occurred in 3.7%
of patients with 27.6% of those involving negligence.
-over 70% of adverse events contributed to disability
lasting less than 6-months, with 2.6% resulting in
permanent disability, and 13.6% leading to death.
During a Hospitalization
(continued):
-patients aged 65 years and older accounted for 27% of
the hospitalized population but 43% of all adverse
events.
-patients aged 65 years and older had a two-fold risk for
developing adverse events when compared to individuals
between 16 and 44 years.
Table 1: Rates of Adverse Events and Negligence among
Clinical-Specialty Groups in New York State (1984)
Specialty
Orthopedics
Urology
Neurosurgery
Thoracic and cardiac surgery
Vascular surgery
Obstetrics
Neonatology
General surgery
General Medicine
P value
Rate of Adverse Events(%)
Rate of Negligence(%)
4.1
4.9
9.9
10.8
16.1
1.5
0.6
7.0
3.6
22.4
19.4
35.6
23.0
18.0
38.3
25.8
28.0
30.9
<0.001
0.64
Brennan TA, et al. Incidence of adverse events and negligence in hospitalized patients: results of the Harvard
Medical Practice Study I. N Engl J Med. 1991;324:
370-6.
Table 2: Types of Adverse Events and Proportion of Events Involving Negligence in
New York State (1984)
Type of Event
In Population(%) Due to Negligence(%) With Serious Disability(%)
Operative
Wound infection
Technical complication
Late complication
Non-technical complication
Surgical Failure
13.6
12.9
10.6
7.0
3.6
12.5
17.6
13.6
20.1
36.4
17.9
12.0
35.7
43.8
17.5
Non-operative
Drug-related
Diagnostic mishap
Therapeutic mishap
Procedure-related
Fall
Fractures
Postpartum
Anesthesia-related
Neonatal
19.4
8.1
7.5
7.0
2.7
1.2
1.1
1.1
0.9
17.7
75.2
76.8
15.1
------
14.1
47.0
35.0
28.8
------
P value
<0.01
Leape LL, et al. The nature of adverse events in hospitalized patients: results of the Harvard Medical Practice Study II.
N Engl J Med. 1991;324:377-84.
Table 3: Drug-Related Adverse Events, According to Class of Drug
Involved in New York State (1984)
Drug Class
Antibiotic
Anti-tumor
Anticoagulant
Cardiovascular
Anti-seizure
Diabetes
Antihypertensive
Analgesic
Anti-asthmatic
Sedative or hypnotic
Antidepressant
Antipsychotic
Peptic ulcer
Adverse Events (%)
16.2
15.5
11.2
8.5
8.1
5.5
5.0
3.5
2.8
2.3
0.9
0.7
0.5
Leape LL, et al. The nature of adverse events in hospitalized patients: results of the Harvard Medical Practice Study II.
N Engl J Med. 1991;324:377-84.
Table 4: Sites of Care that Resulted in Adverse Events in New York
State (1984)
Site of Care
In Sample(%)
Due to Negligence(%) With Serious Disability(%)
In hospital
Operating room
Patient’s room
Emergency room
Labor and delivery room
Intensive care unit
Radiology
Cardiac catheterization laboratory
Ambulatory care unit
41.0
26.5
2.9
2.8
2.7
2.0
0.9
0.8
13.7
41.1
70.4
27.7
30.2
36.9
---
22.0
30.4
24.8
9.8
50.4
35.4
---
Outside hospital
Physician’s office
Home
Ambulatory care unit
Nursing home
7.7
2.7
1.4
0.9
31.2
11.4
53.6
--
21.0
8.2
13.7
--
P value
<0.01
Leape LL, et al. The nature of adverse events in hospitalized patients: results of the Harvard Medical Practice Study II.
N Engl J Med. 1991;324:377-84.
During a Hospitalization
• Utah and Colorado Medical Practice Study
(Med Care 2000):
-2nd medical practice study to randomly select a large
number of records involving many institutions and
develop more current and more reliable estimates for
the incidence of adverse events and negligence.
-sampled 15,000 hospitalized patients in 1992.
-adverse events related to treatment occurred in
2.9% of patients.
-overall results were similar to those of the Harvard
Medical Practice Study.
During a Hospitalization
• The 1st Institute of Medicine Report on Patient
Safety, “To Err is Human” (2000):
-estimated 44,000-98,000 deaths, with 1 million injuries,
from medical errors annually in US hospitals based on
the Harvard and Utah/Colorado Medical Practice Studies.
-annual cost estimated between $17 and $29 billion in 1996.
-set forth a national agenda to reduce errors and
improve the quality of care.
-stimulated national initiatives from governmental,
business, and medical leaders to reduce errors.
During a Hospitalization
• The 2nd Institute of Medicine Report on
Patient Safety, “Crossing the Quality Chasm”
(2001):
-highlighted quality-related issues by providing
strategies to redesign the current health care
system.
-emphasized the use of existing medical knowledge
and information technology by clinicians to properly
care for their patients.
During a Hospitalization
• Hospital Patient Safety Indicators (PSIs) (AHRQ
Report 2002):
-developed by the Stanford U – UCSF Evidence Based
Practice Center for AHRQ.
-purpose to screen for potential inhospital safety problems
(surgical complications and some medical care) using a
computerized algorithm involving ICD-9-CM codes.
-resulted from a 4-step process: literature review,
evaluation of candidate PSIs by clinical panels,
consultation with coding experts, and empirical
analyses of candidate PSIs.
During a Hospitalization
Accepted AHRQ Hospital PSIs:
(1) Complications of Anesthesia
(2) Death in low mortality DRGs
(3) Decubitus ulcer
(4) Failure to rescue
(5) Foreign body left during procedure
(6) Iatrogenic pneumothorax
(7) Infection due to medical care
(8) Accidental puncture or laceration
During a Hospitalization
(continued):
(9) Postoperative hip fracture
(10) Postoperative hemorrhage or hematoma
(11) Postoperative physiologic and metabolic derangements
(12) Postoperative respiratory failure
(13) Postoperative PE or DVT
(14) Postoperative sepsis
(15) Postoperative wound dehiscence
(16) Transfusion reaction
During a Hospitalization
(1) Postoperative PE or DVT:
definition and numerator = discharges with ICD-9CM codes for PE or DVT in any secondary
diagnosis field per 1000 surgical discharges.
denominator = includes all surgical discharges;
excludes pts with a principal diagnosis of DVT;
excludes all obstetric admissions; and excludes pts
with secondary procedure codes for PE, when PE
procedures occur on the day of or previous to the
day of the principle procedure.
During a Hospitalization
(2) Postoperative physiologic & metabolic derangements:
definition and numerator = discharges with ICD-9CM codes for physiologic & metabolic derangements in
any secondary diagnosis field per 1000 surgical
discharges; and discharges with acute renal failure must
be accompanied by a procedure code for hemodialysis.
During a Hospitalization
(continued):
denominator = include all elective surgical discharges;
exclude pts with both a diagnosis code of ketoacidosis,
hyperosmolarity, or other coma, and principle diagnosis
of diabetes mellitus; exclude pts with both a secondary
diagnosis code for acute renal failure and a principal
diagnosis of acute MI, cardiac arrhythmia, cardiac arrest,
shock, hemorrhage or GI hemorrhage; and exclude all
obstetric admissions.
During a Hospitalization
(3) Failure to rescue:
definition and numerator = all discharges with
disposition of “deceased” per 1000 population at risk.
denominator = include discharges with potential
complications of care listed in failure to rescue
definition (e.g., pneumonia, PE/DVT, sepsis, acute
renal failure, shock/cardiac arrest, or GI
hemorrhage/acute ulcer); and exclude pts transferred to
an acute care facility, transferred from an acute care
facility, or admitted from a long-term care facility.
Table 5: Rates of Patient Safety Indicator (PSI) Events in VA Data (FY 2001) (n=430,552)*
PSI # Patient Safety Indicator
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
Numerator
Complications of anesthesia
Death in low mortality DRGs
Decubitus ulcer
Failure to rescue
Foreign body left in during procedure
Iatrogenic pneumothorax
Infection due to medical care
Postoperative hip fracture
Postoperative hemorrhage or hematoma
Postop physiologic & metabolic derangements
Postoperative respiratory failure
Postoperative pulmonary embolism or DVT
Postoperative sepsis
Postoperative wound dehiscence
Technical difficulty with procedure
Transfusion reaction
55
178
3207
3316
73
469
817
81
315
77
107
1262
106
129
1216
3
Denominator
Unadjusted
97,482
55,079
208,097
21,318
430,536
402,185
345,442
71,053
97,479
40,788
31,207
97,231
17,283
20,115
430,524
430,536
0.56
3.23
15.41
155.55
0.17
1.17
2.37
1.14
3.23
1.89
3.43
13.00
6.13
6.41
2.82
0.007
RiskAdjusted†
.059
1.99
18.36
156.16
0.17
1.20
1.86
1.33
2.90
1.81
2.00
10.62
6.62
4.49
3.82
-
HCUP-NIS
2000¶
0.72
0.42 ‡
21.56 §
148.40 ‡
0.09 ‡
0.70
2.01 §
0.82 ‡
2.24
1.14 ‡
3.66 §
8.96 ‡
11.26 §
2.06
3.40 ‡
0.0040
Medicare
2000║
3.10 §
29.70 §
165.20 §
1.10
2.80 §
1.80 §
2.60
1.30 ‡
7.50 §
12.00 §
12.70 §
3.70
3.20 ‡
-
Note: All rates are reported per 1000 discharges at risk using Patient Safety Indicator software, Version 2.1, Revision 1. (Revision 2 was recently released.
Preliminary results suggest that only rates for postoperative hip fracture and postoperative pulmonary embolism or changed noticeably- both decreased.)
*Rates are calculated based on 430,552 acute care hospitalizations using the VA Health Economics Resource Center’s (HERC) definitions of acute and non-acute
bedsections.
†Adjusted for age, sex, age-sex interactions, modified DRGs, and modified comorbidities (reference population is Healthcare Cost and Utilization Project State
Inpatient Database (HCUP-SID 2000)).
‡VA risk-adjusted rates are significantly higher based on 95% confidence intervals.
§VA risk-adjusted rates are significantly lower basde on 95% confidence intervals.
¶National Healthcare Quality Report 2003 (all rates are risk-adjusted as above except for “transfusion reaction”).
║Report to the Congress: Medicare Payment Policy 2004 (all rates are risk-adjusted as above). PSIs #1,5, and 16 were not calculated due to infrequent events.
Rosen AK, et al. Evaluating the Patient Safety Indicators: How Well Do They Perform on Veterans Health Administration Data? Med Care. 2005;43:873-884.
Figure 3: Comparison of Median Length of Stay (Days) for
Hospitalizations with PSI Events Versus Hospitalizations without
PSI Events in the VA (FY 2001)
35
PSI
30
30
No PSI
24
25
23
20
20
15
10
8
6
4
5
5
0
Postoperative
Wound
Dehiscence
P<0.0001
Postoperative
Sepsis
P<0.0001
Postoperative Postoperative
Respiratory Physiologic and
Failure
Metabolic
P<0.0001
Derangements
P<0.0001
Rosen AK, et al. Evaluating the Patient Safety Indicators: How Well Do They Perform on Veterans Health Administration Data? Med Care.
2005;43:873-884.
Figure 4: Comparison of In-Hospital Mortality (Deaths per
1000) for Hospitalizations with PSI Events Versus
Hospitalizations without PSI Events in the VA (FY 2001)
500
456
PSI
400
No PSI
368
300
300
225
200
100
53
11
11
7.2
0
Postoperative
Physiologic
and Metabolic
Derangements
P<0.0001
Postoperative
Sepsis
P<0.0001
Postoperative
Respiratory
Failure
P<0.0001
Postoperative
Wound
Dehiscence
P<0.0001
Rosen AK, et al. Evaluating the Patient Safety Indicators: How Well Do They Perform on Veterans Health Administration Data? Med Care.
2005;43:873-884.
Figure 5: Comparison of Median Estimated Cost (Thousands of
Dollars) for Hospitalizations with PSI Events Versus
Hospitalizations without PSI Events in the VA (FY 2001)
$80
PSI
$60
No PSI
$57.00
$53.47
$49.17
$48.44
$40
$20
16.184
13.94
9.32
10.983
$0
Postoperative
Wound
Dehiscence
P<0.0001
Postoperative
Sepsis
P<0.0001
Postoperative Postoperative
Respiratory Physiologic and
Failure
Metabolic
P<0.0001
Derangements
P<0.0001
Rosen AK, et al. Evaluating the Patient Safety Indicators: How Well Do They Perform on Veterans Health Administration Data? Medical Care.
2005;43:873-884.
Medical errors and adverse
events result primary because of
93%
1. poor information transfer
2. faulty communication
3. poor information transfer
& faulty communication
5%
1
2%
2
3
The inpatient adverse event rate identified in
the Harvard Medical Practice Study was
1. 2.4%
2. 1.8%
3. 3.7%
63%
28%
10%
1
2
3
During a Hospitalization
(Children)
• Utah and Colorado Study (Pediatrics 2005):
-1st study to randomly select a large number of
records involving several institutions and reliably estimate
the incidence of adverse events and preventable adverse
events in children.
-data suggested that ~70,000 children hospitalized in
the United States experience an adverse event
annually.
-sampled 3,719 discharged hospitalized children and 7,528
discharged hospitalized nonelderly adults using 1992 data.
During a Hospitalization
-adverse events related to treatment occurred in 1% of
hospitalized children.
-60% of these adverse events may be preventable.
-future research should focus on adolescent
hospitalized patients, birth-related medical care, and
diagnostic errors in pediatrics.
Table 6: Rates and Preventable Adverse Events by Age Group
Age Group
(Years)
Adverse Events
Rate (95% CI)
Proportion of
Preventable Adverse Events
Preventable Adverse
Events Rate (95% CI)
0–0.99
0.63 (0.43–0.83)
78.0
0.53 (0.33–0.73)
1–12.99
0.92 (0.62–1.22)
10.8
0.22 (0.12–0.32)
13–20.99
3.41 (3.36–3.46)
78.6
0.95 (0.65–1.25)
21–65.99
3.84 (3.79–3.89)
40.7
1.50 (1.20–1.80)
Woods D, et al. Adverse Events and Preventable Adverse Events in Children. Pediatrics. 2005;115:155-160.
Table 7: Distribution of Adverse Events and Preventable
Adverse Events by Type: Children and Nonelderly Adults
Type
Proportion (%) of
Adverse Events
(95% CI)*
Proportion (%) of
Preventable Adverse
Events (95% CI)
Proportion of
Preventable Adverse
Events (95% CI) in
Nonelderly Adults
Birth related
Diagnostic
Medication
Surgical
Postpartum
Therapeutic
Nonsurgical
procedures
29.6 (17.1–42.2)
21.3 (12.5–30.1)
19.1 (12.1–26.1)
16.3 (4.4–28.2)
6.1 (1.9–10.3)
0.8 (0.4–1.2)
32.2 (15.8–48.6)
30.4 (14.3–46.5)
21.3 (6.9–35.7)
3.5 (0–9.9)
8.7 (0–18.6)
2.8 (0–8.6)
—
10.1 (5.2–15.0)
6.6 (2.5–10.4)
54.6 (47.3–61.9)
5.5 (0–11.0)
5.7 (11.9–9.5)
7.7 (0–17.2)
1.1 (0–4.8)
9.6 (5.4–13.8)
Woods D, et al. Adverse Events and Preventable Adverse Events in Children. Pediatrics. 2005;115:155-160.
Table 8: Estimated Frequency Distribution of Pediatric
Adverse Events and Preventable Adverse Events by Covering
Service and Location of the Event
Adverse Events
(95% CI)
Preventable Adverse
Events (95% CI)
Service
Obstetrics
Surgery
Pediatrics
Family practice
Pharmacy
Gynecology
34.2 (47.4–21.0)
18.0 (7.9–28.1)
14.5 (15.2–23.8)
10.3 (2.3–18.3)
9.4 (1.7–17.1)
1.6 (0–5.8)
38.6 (20.9–55.7)
8.5 (0–18.3)
11.4 (0.3–22.5)
16.7 (3.6–29.8)
21.4 (7.0–35.8)
6.8 (2.9–10.7)
Location
Labor and delivery
Pharmacy
Ambulatory care
Operating room
Patient room
Newborn nursery
26.2 (13.8–38.6)
14.9 (10.7–19.1)
17.8 (9.0–26.6)
19.5 (8.4–30.6)
11.8 (1.7–21.9)
4.8 (0–10.6)
26.2 (10.8–41.6)
21.4 (7.0–35.8)
18.9 (5.2–32.6)
11.0 (0–22.0)
15.7 (2.9–28.5)
6.9 (0–15.7)
Woods D, et al. Adverse Events and Preventable Adverse Events in Children. Pediatrics. 2005;115:155-160.
During a Hospitalization
• A Multicenter Study of Children’s Hospitals
(Pediatrics 2008):
-to determine excess charges and lengths of stay
attributable to adverse patient-care events during
pediatric hospitalizations.
-pediatric-specific quality indicators were used to
identify adverse events in 431,524 discharges from
38 pediatric hospitals in the United States
participating in the Pediatric Health Information
System (PHIS) database in 2006.
During a Hospitalization
-primary outcomes were excess lengths of stay and
charges attributable to adverse patient-safety
events as determined by 12 pediatric-specific quality
indicators.
Table 9: PHIS Rates for AHRQ PDIs in 2006
Variable
Accidental puncture
and laceration
Decubitus ulcer
Foreign body left in
during procedure
Iatrogenic pneumothorax
neonate
Iatrogenic pneumothorax
non-neonates
In-hospital mortality after
pediatric heart surgery
Postoperative hemorrhage
or hematoma
Postoperative respiratory
failure
Postoperative sepsis
PHIS, No.
of Events
PHIS Risk
Pool
PHIS Rate per 1000
Discharges at Risk
Children’s Hospitals
Rate Reported by
AHRQa
679
374
427616
82707
1.59
4.52
1.58
4.33
40
427650
0.09
0.07
13
10753
1.21
0.68
144
392647
0.37
0.44
402
10158
39.57
46.66b
206
53052
3.88
1.76
1076
958
42767
34455
25.16
27.80
17.03
31.33
Kronman MP, et al. Charges and Lengths of Stay Attributable to Adverse Patient-Care Events Using Pediatric-Specific Quality Indicators: A
Multicenter Study of Freestanding Children’s Hospitals. Pediatrics. 2008;121:e1653-e1659.
Table 9: PHIS Rates for AHRQ PDIs in 2006
(continued)
Variable
Postoperative wound
dehiscence
Infection because of
medical care
Transfusion reaction
PHIS, No.
of Events
PHIS Risk
Pool
PHIS Rate per 1000
Discharges at Risk
Children’s Hospitals
Rate Reported by
AHRQa
18
20101
0.90
0.82
2736
10
323253
380112
8.46
0.03
6.15
0.002
a Data are based on the Healthcare Cost and Utilization Project KID 2003.
b Data show the overall rate. The children’s hospital rate was not reported by the AHRQ.
Kronman MP, et al. Charges and Lengths of Stay Attributable to Adverse Patient-Care Events Using Pediatric-Specific Quality Indicators: A
Multicenter Study of Freestanding Children’s Hospitals. Pediatrics. 2008;121:e1653-e1659.
Table 10: Excesses in LOS and Total Charges for Patient
Safety Events Flagged in the PHIS
Variable
Accidental puncture and laceration
Decubitus ulcer
Foreign body left in during procedure
Iatrogenic pneumothorax neonate
Iatrogenic pneumothorax
In-hospital mortality after
pediatric heart surgery
Postoperative hemorrhage or hematoma
Postoperative respiratory failure
Postoperative sepsis
Postoperative wound dehiscence
Infection because of medical care
Transfusion reaction
Matched
Rate, % a
Excess LOS
Mean (SE), days
Excess Total Charges
Mean (SE), dollars
82
62
85
92
69
2.77 (1.06)b
8.07 (1.73)b
14.30 (7.23)b
-1.61 (26.51)
3.39 (2.11)
34 884 (8891)b
59 225 (17 581)b
144 889 (79 488)
77 365 (208 750)
53 604 (19 355)b
49
78
37
53
67
73
70
12.92 (4.40)
6.17 (2.70)
4.80 (2.09)b
23.52 (2.29)b
7.32 (4.85)
22.43 (1.02)b
12.26 (13.76)
337 226 (44 039)b
111 653 (35 094)b
77 739 (18 769)b
261 173 (22 795)b
69 220 (43 851)
172 484 (9400)b
45 313 (59 340)
a Data show the percentage of case subjects who could be matched to1 control subject.
b Data denote the statistically significant difference (P.006) after the Bonferroni correction.
Kronman MP, et al. Charges and Lengths of Stay Attributable to Adverse Patient-Care Events Using Pediatric-Specific Quality Indicators: A
Multicenter Study of Freestanding Children’s Hospitals. Pediatrics. 2008;121:e1653-e1659.
After Discharge
• United States Post-Discharge Study (Forster AJ,
et al. The incidence and severity of adverse events
affecting patients after discharge from hospital. Ann Intern
Med. 2003;138:161-7)
-landmark study on post-discharge adverse events.
-reported a 19% adverse event incidence rate
among patients discharged home from the general
internal medicine service of a major teaching
hospital (Brigham & Women’s Hospital in Boston).
-66% were adverse drug events, 17% were
procedure-related problems, 5% were nosocomial
infections, and 4% were falls.
-1/3 were preventable and 1/3 were ameliorable
adverse events.
After Discharge
• Canadian Post-Discharge Study (Forster AJ, et al.
Adverse events among medical patients after discharge from
hospital. CMAJ. 2004;170:345-9)
-reported a 23% adverse event incidence rate
among patients discharged home from the general
internal medicine service of a major teaching
hospital (Ottawa Hospital in Ottawa, Canada).
-76% were adverse drug events, 16% were
therapeutic errors, 11% were nosocomial
infections, 7% were procedure-related problems, 7%
were pressure ulcers, 6% were diagnostic errors,
and 2% were falls.
After Discharge
• As a result of post-discharge adverse events,
both the US and Canadian studies reported:
9% - 21% of pts required an additional physician visit
17% - 24% of pts required a hospital readmission
11% - 12% of pts required an ED visit
3% of pts experienced death
After Discharge
• In the Canadian post-discharge study:
14% of hospital readmissions were preventable
2% of hospital readmissions were ameliorable
6% of ED visits were preventable
6% of ED visits were ameliorable
14% of deaths were preventable
Table 11:
Common Types of Post-Discharge Adverse Events
Adverse Event Type
IR
Drug Related*
Drug Related¶
Drug Related†
72%
66%
25%
N/A
50%
11%
N/A
76%
28%
Procedure Related¶
Procedure Related*
17%
7%
8%
N/A
12%
N/A
Therapeutic Errors*
16%
N/A
N/A
Nosocomial Infections*
Nosocomial Infections¶
11%
5%
N/A
0%
N/A
4%
Pressure Ulcers*
7%
N/A
N/A
Diagnostic Errors*
6%
N/A
N/A
Falls¶
Falls*
4%
2%
8%
N/A
0%
N/A
Preventable IR Ameliorable IR
IR=Incidence Rate. N/A=Not Available.
*Forster AJ, et al. Adverse events among medical patients after discharge from hospital. CMAJ. 2004;170:345-349.
¶Forster AJ, et al. The incidence and severity of adverse events affecting patients after discharge from hospital. Ann Intern Med. 2003;138:161-7.
†Gandhi TK, et al. Adverse drug events in ambulatory care. N Engl J Med. 2003;348:1556-64.
Post-Discharge Adverse Events
(Percent)
Figure 6: The Most Common Drugs Causing
Post-Discharge Adverse Events
50
40
38
30
20
16
14
10
10
8
0
Antibiotics
Cortico-
Cardio-
steroids
vascular
Analgesics
Anticoagulants
Drugs
Forster AJ, et al. The incidence and severity of adverse events affecting patients after discharge from hospital. Ann Intern Med. 2003;138:161-7.
Diagnostic Errors
• Diagnostic error , is defined as a diagnosis that is
missed, wrong, or delayed, as detected by some
subsequent definitive test or finding.
• Not all diagnostic errors result in harm to the patient, and
harm may be due to either disease or intervention.
• Misdiagnosis related harm, is defined as preventable
harm that results from the delay or failure to treat a
condition actually present (when the working diagnosis
was wrong or unknown) or from treatment provided for a
condition not actually present.
Tsilimingras D, et al. Patient Safety in Geriatrics: A Call for Action. J Gerontol Med Sci. 2003;58A:813-819.
Newman-Toker DE, et al. Diagnostic errors: the next frontier for patient safety. JAMA. 2009;301:1060-1062.
Diagnostic Errors
• An estimated 40,000 to 80,000 hospital deaths result from
mis-diagnosis annually in the US.
• Approximately 5% of autopsies reveal lethal diagnostic
errors.
• During a hospitalization (Harvard Medical Practice Study),
8% of adverse events resulted from misdiagnoses, 75% of
misdiagnoses were considered negligent, and 47% of
misdiagnoses resulted in serious disability to the patient.
• After discharge from the hospital (Canadian PostDischarge Study), 6% of adverse events resulted from
misdiagnoses.
Newman-Toker DE, et al. Diagnostic errors: the next frontier for patient safety. JAMA. 2009;301:1060-1062.
Leape LL, et al. The nature of adverse events in hospitalized patients: results of the Harvard Medical Practice Study II.
N Engl J Med. 1991;324:377-84.
Forster AJ, et al. Adverse events among medical patients after discharge from hospital. CMAJ. 2004;170:345-349.
Diagnostic Errors
Comparison of Types of Preventable Adverse Events
Between Children and Adults (Utah and Colorado Study)
Types of Preventable Adverse Events
Diagnostic
Surgical
Postpartum
Nonoperative procedure
Medication
Therapeutic
All types
OR (Odds Ratio)
1.352
0.107
0.527
0.016
0.346
0.099
0.501
P Value
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
• Children are 1.35 times more likely to experience a
preventable adverse event as a result of a diagnostic error
than adults during a hospitalization.
Woods D, et al. Adverse Events and Preventable Adverse Events in Children. Pediatrics. 2005;115:155-160.
The adverse event rate after discharge
from the hospital ranges between
1. 19%-23%
2. 15%-18%
3. 4%-7%
58%
35%
8%
1
2
3
Recommendations for Improvement
(A) Identifying System Failures:
• If a misdiagnosis is not detected or reported, the
identification of systemic failures and the initiation of
immediate medical attention (for a condition that was
missed) will not occur.
• The failure to identify systemic failures and to initiate
immediate medical attention will result in avoidable harm
to patients.
Recommendations for Improvement
(1) Physicians must detect and report a misdiagnosis.
(2) Identify underlying system failures that resulted in a
misdiagnosis.
Example: Identify a new-onset of a condition and retrospectively
outline the sequential chain of clinical events leading to its
(condition) occurrence. The sequential chain of clinical events
may include human factors as the reason that physicians
failed to recognize the occurrence of a condition, technical
factors involving a computer system, or organizational factors
such a payment system that required preauthorization for the
care of patients.
Tsilimingras D, et al. Patient Safety in Geriatrics: A Call for Action. J Gerontol Med Sci. 2003;58A:813-19.
Recommendations for Improvement
(3) By outlining the sequence of clinical events that led to a
misdiagnosis, physicians would be able to identify
systemic failures and develop solutions to reverse their
outcome.
Recommendations for Improvement
(B) Improving Transitional Care:
(1) By creating transitional care teams that include a
physician, nurse coordinator, dietician, pharmacist,
psychologist, and social worker.
(2) Transitional care teams should follow a patient
during the inpatient setting, transitional interface, and
outpatient setting.
(3) Transitional care teams have significantly reduced
readmissions, ER visits, deaths, adverse events, and
cost of care.
Tsilimingras D , et al. Addressing Post-Discharge Adverse Events: A Neglected Area. Joint Commission
Journal on Quality & Patient Safety. 2008;34(2):85-97.
Recommendations for Improvement
(C) Improving Information Transfer Through Strategic Use
of Electronic Health Records (EHRs):
(1) Implementing inpatient and outpatient EHRs.
(2) Linking inpatient and outpatient EHRs.
(3) Creating and linking patient personal EHRs.
Tsilimingras D, et al. Addressing Post-Discharge Adverse Events: A Neglected Area. Joint Commission
Journal on Quality & Patient Safety. 2008;34(2):85-97.
Recommendations for Improvement
Example: a physician that examines a patient in the
hospital for the 1st time should have access to the
patient’s recent outpatient and/or inpatient EHR
prior to making medical decisions for the care of
that particular patient. By outlining the sequence of
clinical events and therapeutic modifications for that
particular patient, physicians would be able to make
informed decisions in the care of patients when they
are seen inside and outside the hospital.
Tsilimingras D, et al. Addressing Post-Discharge Adverse Events: A Neglected Area. Joint
Commission Journal on Quality & Patient Safety. 2008;34(2):85-97.
Recommendations for Improvement
(4) Implementing Computerized Physician Order Entry
(CPOE) & computerized alert monitors within EHRs:
(a) in hospitals and home care.
(b) to properly transfer a patient’s drug info between
inpatient and outpatient pharmacies (and vice
-versa).
(c) these systems have reduced prescribing errors by
more than 50%.
(d) these systems are effective and imperative for
reducing the rate of potential adverse drug events.
Tsilimingras D, et al. Patient Safety in Geriatrics: A Call for Action. J Gerontol Med Sci. 2003;58A:813-19.
Recommendations for Improvement
(5) An early intervention by a pharmacist can improve
poor information transfer and faulty communication
between inpatient and outpatient care in addition to
EHRs.
Tsilimingras D, et al. Addressing Post-Discharge Adverse Events: A Neglected Area. Joint
Commission Journal on Quality & Patient Safety. 2008;34(2):85-97.
Recommendations for Improvement
Example: Randomized trial included 92 pts in the
intervention group and 84 pts in the control group
from the IM service of a large teaching hospital (Arch
Intern Med 2006).
- A pharmacist reviewed all meds and counseled
pts regarding potential side effects at discharge,
along with a follow-up phone call 3-5 days after
discharge.
- Only 1% of patients in the intervention group
experienced preventable adverse drug events
compared to 11% of patients that experienced
preventable adverse drug events in the control group.
Schnipper JL, et al. Role of pharmacist in preventing adverse drug events after hospitalization. Arch Intern
Med. 2006;166:565-571.
Recommendations for Improvement
(6) Implementing structured database-generated
physician discharged summaries.
(7) Implementing structured cross-coverage sign-outs
between physicians.
(8) Implementing a comprehensive discharge planning
process.
(9) Require proper patient notification and follow-up of
abnormal laboratory test results.
Tsilimingras D, et al. Patient Safety in Geriatrics: A Call for Action. J Gerontol Med Sci. 2003;58A:813-19.
Tsilimingras D, et al. Addressing Post-Discharge Adverse Events: A Neglected Area. Joint Commission
Journal on Quality & Patient Safety. 2008;34(2):85-97.
Recommendations for Improvement
(D) Medication Reconciliation:
(1) A process of identifying the most accurate list of all
medications a patient is taking at interfaces of care.
(2) Includes the identification of a medication’s name,
dose, frequency and route, and the subsequent use of
this information to provide correct medications for
patients within the health care system.
(3) The process also involves comparing a patient’s current
list of medications with a physician’s admission,
transfer, and/or discharge orders.
Tsilimingras D , et al. Addressing Post-Discharge Adverse Events: A Neglected Area. Joint Commission
Journal on Quality & Patient Safety. 2008;34(2):85-97.
Recommendations for Improvement
(E) Utilizing Screening Methods to Identify Patients With
Adverse Events:
(1) Inpatient computerized programs which use ICD-9-CM
codes to identify medical or surgical complications.
(2) Inpatient computerized programs that combine
microbiology, pharmacy, and clinical laboratory data to
identify adverse events.
(3) Outpatient computerized programs which use ICD-9CM codes and combine laboratory and pharmacy data
to identify adverse events.
Tsilimingras D, et al. Addressing Post-Discharge Adverse Events: A Neglected Area. Joint
Commission Journal on Quality & Patient Safety. 2008;34(2):85-97.
Recommendations for Improvement
(F) Performing Root Cause Analysis (RCA):
(1) To identify the underlying system and organizational
problems that led to the adverse event or events.
(2) It will not be practical for every adverse event.
(3) It should be performed when a pattern of events is
identified or even a single very serious event.
(4) A systematic RCA may expose common root causes
that link several serious adverse events at a particular
time of occurrence and help design systems to prevent
future incidents.
Tsilimingras D, et al. Addressing Post-Discharge Adverse Events: A Neglected Area. Joint
Commission Journal on Quality & Patient Safety. 2008;34(2):85-97.
Recommendations for Improvement
(G) Improving Residency and Fellowship Programs:
(1) No matter how clinically skilled physicians may be,
they will not be able to provide optimal patient care
unless the system is appropriately structured.
(2) Advocating for such a system is not easy and requires
advocacy and management skills that are not part of
current residency programs.
(3) Residency programs should emphasize the
recommendations mentioned here and continue to
emphasize skills in patient-centered care and
evidence-based practice.
Tsilimingras D, et al. Patient Safety in Geriatrics: A Call for Action. J Gerontol Med Sci. 2003;58A:813-19.
Conclusions
(A) Enhanced care can be achieved by adopting wellestablished safety recommendations such as the ones
mentioned here.
(B) The recommendations mentioned here, are only the tip
of the iceberg in confronting the magnitude of this
problem.
(C) Additional recommendations and further research in this
area are critical in improving the quality and safety of
patient care.
Tsilimingras D, et al. Addressing Post-Discharge Adverse Events: A Neglected Area. Joint
Commission Journal on Quality & Patient Safety. 2008;34(2):85-97.
The Second Victim
• The second victim of a medical error, besides the patient, is
the physician that cared for the patient.
• Implications for the second victim:
-emotional and psychological
-may result in a career change
• Patient Safety Organizations (PSO)
-created by the Patient Safety Act of 2005
-encourages clinicians and health care organizations
to voluntarily report and share quality and patient
safety information without fear of legal discovery.
Wu AW. Medical error: the second victim. BMJ. 2000;320:726-727.
AHRQ, http://www.pso.ahrq.gov/