U.S. Department of Health and Human Services 
Office of Inspector General 
 
 
Adverse Events in 
Long-Term-Care 
Hospitals: National 
Incidence Among 
Medicare 
Beneficiaries 
 
OEI-06-14-00530 
November 2018 
Daniel R. Levinson 
 
Inspector General 
oig.hhs.gov  Report in Brief  U.S. Department of Health and Human Services 
November 2018 
Office  of Inspector General 
OEI-06-14-00530 
 
 
Adverse Events in Long-Term-Care Hospitals: 
Why OIG Did This Review 
National Incidence Among Medicare Beneficiaries 
In a series of reports from  
2008 to 2016, OIG found that 
Long-term-care hospitals (LTCHs) are inpatient 
adverse events and temporary 
hospitals that treat patients who are very illoften  Key Takeaway 
harm events are common, 
with several acute and/or chronic conditionsand  Almost half (46 percent) of 
endanger patient health, and 
require care for an extended period.  LTCHs  Medicare patients in long-term-
are costly to the Medicare 
provide continued, acute-level care for patients  care hospitals experienced adverse 
program.  In a 2010 study, OIG 
following their stays in traditional acute-care  events (21 percent) or temporary 
found that 27 percent of 
hospitals.  harm events (25 percent) during 
hospitalized Medicare 
their stays.  In many cases, 
beneficiaries experienced such 
What OIG Found 
physician reviewers determined 
events, costing Medicare 
The Office of Inspector General (OIG) found that  that the harm could have been 
approximately $4.4 billion a 
21 percent of Medicare patients in LTCHs  prevented if the hospitals had 
year.  OIG then expanded on 
experienced adverse events, which are particularly  provided better care; in other 
this work by examining post-
serious instances of patient harm resulting from  cases, patients health conditions 
acute-care settings, finding 
medical care.  The four categories of adverse  made them susceptible and the 
that 33 percent of Medicare 
events include outcomes such as prolonging  harm was not preventable.  
beneficiaries in skilled nursing 
a patients LTCH stay or necessitating transfer to 
facilities and 29 percent of 
another facility; requiring life-saving intervention; 
Medicare beneficiaries in 
resulting in permanent harm; and contributing to death.  (Five percent of Medicare 
rehabilitation hospitals 
patients in LTCHs experienced adverse events that contributed to or resulted in their 
experienced harm.  This report 
deaths.)  An additional 25 percent of patients experienced temporary harm events, which 
builds upon this prior work, 
are patient harm that required medical intervention but did not cause lasting harm.   
focusing on Medicare stays in 
The overall percentage of patients in LTCHs who experienced either type of harm (adverse  LTCHs. 
events or temporary harm events) is 46 percent, higher than OIG found in hospitals 
(27 percent), skilled nursing facilities (33 percent), and rehabilitation hospitals (29 percent).   How OIG Did This Review 
Patient stays in LTCHs present more opportunities for harm events because the stays are  OIG reviewed medical records 
longer, but the number of harm events per patient day was similar between LTCHs and  for 587 Medicare beneficiaries 
other post-acute-care settings and lower than in non-LTCH acute-care hospitals.    admitted to LTCHs in 
March 2014 to establish a 
Over half of these adverse events and temporary harm events (54 percent of harm events) 
national incidence rate of 
were clearly or likely preventable.  Preventable harm events were often related to 
adverse events and temporary 
substandard care (58 percent) and medical errors (34 percent).  Forty-five percent of harm 
harm events.  The review was 
events were found to be clearly or likely not preventable, often because the patients were 
conducted in two stages.  In 
highly susceptible to harm due to other health conditions or poor overall health. 
the first stage, nurses screened 
What OIG Recommends   records for possible harm 
In response to prior OIG work, the Centers for Medicare & Medicaid Services (CMS) and  events.  In the second stage, 
Agency for Healthcare Research and Quality (AHRQ) took important steps to raise  physicians conducted a 
awareness of adverse events and temporary harm events and to reduce harm in several  comprehensive review of the 
inpatient settings.  AHRQ and CMS should tailor their ongoing efforts to improve patient  records flagged as containing 
safety to address the specific needs of LTCHs.  We recommend that AHRQ and CMS  possible harm events. 
collaborate to create and disseminate a list of potential harm events in LTCHs and that  Physicians identified the harm 
CMS include information about patient harm in its outreach to LTCHs.  CMS and AHRQ  events, determined the level of 
concurred with our recommendations.  harm, whether the events were 
preventable, and the factors 
Full report can be found at oig.hhs.gov/oei/reports/oei-06-14-00530.asp  that contributed to the events.   
TABLE OF CONTENTS 
BACKGROUND   1 
Methodology  4 
   
FINDINGS    
Twenty-one percent of Medicare patients had adverse events during their LTCH stays   8  
An additional 25 percent of Medicare patients had temporary harm events during   10 
their LTCH stays 
 
Longer stays in LTCHs present more opportunities for adverse  events and temporary  
12
harm events 
Over half of adverse events and temporary harm events were preventable   14 
   
CONCLUSION AND RECOMMENDATIONS   
AHRQ and CMS should collaborate to  create and disseminate a list of potential adverse events  19 
in LTCHs 
CMS should include information about potential events and patient harm in its quality  20  
outreach to LTCHs 
 
AGENCY COMMENTS AND OIG RESPONSE   21 
 
APPENDICES    
A: Methodology for Identifying Events and Determining Preventability   22  
B: Glossary of Selected  Terms   27  
C: LTCH Trigger Tool Worksheet   29  
D: Estimates,  Confidence  Intervals, and Key Statistics  31 
E: Rates of  Adverse Events and Temporary Harm Events by Patient Days and LTCH Admissions   37  
F: Adverse Events and  Temporary Harm Events Identified in the  Sample   39 
G: Agency Comments  58  
   
ACKNOWLEDGMENTS   61 
 
   
BACKGROUND 
Objectives 
1.  To estimate the incidence of adverse events and temporary harm 
events for Medicare patients admitted to long-term-care hospitals 
(LTCHs),  
2.  To assess the extent to which adverse events and temporary harm 
events were preventable and to identify factors contributing to 
these events.  
Adverse Events and  The term adverse event describes harm to a patient as a result of medical 
care or in a healthcare setting, including the failure to provide needed care.  
Temporary Harm 
An adverse event indicates that the care resulted in an undesirable clinical 
Events in Health 
outcome not caused by underlying disease.  We separately identify 
Care  temporary harm events, which are events that harmed patients and required 
medical intervention but did not cause lasting harm.   
Adverse events and temporary harm events include medical errors and 
general substandard care that result in patient harm, such as infection 
caused by the use of contaminated equipment.  However, adverse events 
and temporary harm events do not always involve errors, negligence, or 
poor quality of care and are not always preventable, such as an unexpected 
allergic reaction.1  The Institute for Healthcare Improvement (IHI), a 
nonprofit advisory group to hospitals and other healthcare systems, further 
explains that unpreventable events are only an innovation away from being 
preventable and that including all causes of harm in research allows for 
better comparisons over time.2  In addition, CMSs Partnership for Patients 
initiative, which focuses on making care safer by reducing 11 core types of 
harm, describes a long-term goal of reducing all-cause harm for Medicare 
beneficiaries.3  All-cause harm includes any event during the care process 
that results in harm to a patient, regardless of the cause.4 
 
 
1 R.M. Wachter, Understanding Patient Safety, 2nd edition, McGraw-Hill, 2012, p.15. 
2 F.A. Griffin and R.K. Resar, IHI Global Trigger Tool for Measuring Adverse Events (Second 
Edition), Institute for Healthcare Improvement Innovation Series 2009, p. 5. 
3 CMS, About the Partnership.  Accessed at https://partnershipforpatients.cms.gov/about-the-
partnership/what-is-the-partnership-about/lpwhat-the-partnership-is-about.html on May 29, 
2018. 
4 CMS, Survey and Certification, S&C: 13-19-Hospitals, March 15, 2013 Accessed at 
https://www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-19.pdf on 
June 5, 2018. 
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  1 
OEI-06-14-00530   
In a series of reports from 20082016, the Office of Inspector General (OIG) 
Office of Inspector 
found that adverse events and temporary harm events are common and 
General Reports on  costly to the Medicare program.5  The OIG reports include incidence rates 
Adverse Events  for all causes of harm, and also provide an assessment by physician 
reviewers of which events were considered preventable.  In a 2010 study, 
OIG found that 27 percent of hospitalized Medicare beneficiaries 
experienced adverse or temporary harm events.6  Nearly half of the events 
were preventable, and hospital care associated with events cost Medicare 
approximately $4.4 billion a year.  OIG also found that hospital staff did not 
recognize or did not report 86 percent of adverse events and temporary 
harm events when they occurred.7   
Following the 2010 study, OIG expanded its work on adverse events by 
examining post-acute-care settings.  In 2014, OIG found that 33 percent of 
Medicare residents in post-acute skilled nursing facility (SNF) stays 
experienced adverse events and temporary harm events.8  Over half 
(59 percent) of these events were preventable, and care associated with 
these events cost Medicare approximately $2.8 billion in a single year.  In 
2016, OIG looked at another post-acute-care setting, rehabilitation (rehab) 
hospitals, and found that 29 percent of Medicare patients experienced 
adverse events during their stay with an estimated cost to Medicare of at 
least $92 million a year.9  This report builds upon previous OIG work in 
post-acute-care settings, focusing on LTCHs.   
Post-Acute Care  LTCHs are inpatient hospitals that specialize in treating long-term and 
clinically complex patients, often with several acute and/or chronic 
in LTCHs 
conditions.  The patients are often very ill and require inpatient care for an 
extended time.  Compared with all Medicare patients, those admitted to 
LTCHs are disproportionately disabled (under age 65), over age 85, or 
diagnosed with end-stage renal disease.  These patients may require 
acute-level services for extended periods of time and many are near the end 
of life.  In 2015, 25 percent of LTCH patients died either in an LTCH or within 
30 days of discharge.10 
 
5 OIG released 12 reports on adverse events in hospitals from 20082016, including reports 
about the incidence of adverse events, methods for identifying adverse events, State 
reporting systems, and public disclosure of event information.  All reports are available at 
https://oig.hhs.gov/newsroom/spotlight/2012/adverse.asp.   
6 OIG, Adverse Events in Hospitals: National Incidence Among Medicare Beneficiaries, OEI-06-
09-00090, November 2010.  
7 OIG, Hospital Incident Reporting Systems Do Not Capture Most Patient Harm, 
OEI-06-09-00091, January 2012.   
8 OIG, Adverse Events in Skilled Nursing Facilities: National Incidence Among Medicare 
Beneficiaries, OEI-06-11-00270, February 2014.  
9 OIG, Adverse Events in Rehabilitation Hospitals: National Incidence Among Medicare 
Beneficiaries, OEI-06-14-00110, July 2016. 
10 Medicare Payment Advisory Commission (MedPAC), Report to Congress:  Medicare 
Payment Policy, March 2017, p. 300. 
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  2 
OEI-06-14-00530   
Over one-third of patients in LTCHs have respiratory conditions, with 
pulmonary edema and respiratory failure (often symptoms of congestive 
heart failure) as the most frequently reported diagnosis.  The second most 
frequently reported diagnosis is respiratory system diagnosis with ventilator 
support for 96 or more hours.  Other common reasons for treatment in 
LTCHs include septicemia or severe sepsis, and complex wound infections.11    
With approximately 400 LTCH providers in the Medicare Program, LTCHs 
are less common than other types of post-acute-care providers and account 
for approximately six percent of Medicare expenditures for post-acute 
care.12, 13  To receive Medicare designation as an LTCH, hospitals must meet 
all the requirements for short-term acute-care hospitals and have an 
average length of stay greater than 25 days.14  In fiscal year 2015, Medicare 
spent $5.3 billion on LTCH care, with an average stay costing Medicare over 
$40,000.15 
Federal Efforts to  Accreditation Organization and State Agency Surveys   
As it does for all Medicare- and Medicaid-certified hospitals, the Centers for 
Improve Quality and 
Medicare & Medicaid Services (CMS) oversees LTCH compliance with a set 
Safety in LTCHs 
of minimum quality and safety standards known as the hospital Conditions 
of Participation (CoPs).16  LTCHs demonstrate compliance with the hospital 
CoPs through on-site surveys conducted by Medicare-approved 
accreditation organizations or State survey agencies.  CMS provides 
interpretive guidance and survey procedures regarding the hospital COPs in 
its State Operations Manual.17 
Quality Assessment and Performance Improvement (QAPI)   
In accordance with the CoPs, LTCHs are required to develop and maintain a 
Quality Assessment and Performance Improvement (QAPI) program.18  To 
satisfy QAPI requirements, LTCHs must track medical errors and adverse 
patient events, analyze their causes, and implement preventive actions and 
mechanisms that include feedback and learning throughout the hospital.19  
To accomplish this, LTCHs must measure, analyze, and track quality 
indicators, including adverse patient events, and other aspects of 
performance that assess processes of care, hospital service, and 
operations.20   
 
11 Ibid. 
12 Ibid.  
13 MedPAC, A Data Book:  Health Care Spending and the Medicare Program, Chart 8-2, June 
2015, p. 114. 
14 Social Security Act  1861(ccc) and 42 CFR  412.23(e). 
15 MedPAC (2017), Op. cit., pp. 289, 300. 
16 The Secretarys authority to establish the CoPs is at Social Security Act  1861(e)(9).  
The current CoPs are found at 42 CFR part 482.   
17 CMS, State Operations Manual 
18 42 CFR  482.21. 
19 42 CFR  482.21(c)(2).  
20 42 CFR  482.21(a)(2). 
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To facilitate comparison and benchmarking of adverse events, the Agency 
for Healthcare Research and Quality (AHRQ), the lead Federal agency 
charged with improving healthcare safety and quality, developed a set of 
definitions and reporting formats for patient safety events, known as the 
Common Formats.  AHRQ encourages the use of the Common Formats by 
hospitals in their internal event reporting systems.21 
LTCH Reporting of Quality Data   
In accordance with the Affordable Care Act, CMS established the LTCH 
Quality Reporting Program and the LTCH Compare website.22, 23, 24  The 
LTCH Compare website is available to the public and currently includes 
eight measures, five of which relate to adverse events, such as the percent 
of patients with pressure ulcers that are new or worsening and rates of 
health-care-associated infections. The Improving Medicare Post-Acute Care 
Transformation Act of 2014 (IMPACT Act) further requires hospitals to 
submit standardized quality measures that allow for comparison among 
post-acute-care providers. 25  LTCHs that fail to submit the required data are 
penalized two percentage points in their annual payment update. 
Methodology  This report estimates the national incidence of adverse events and 
temporary harm events that occurred in LTCHs using a representative 
sample of Medicare beneficiaries in LTCHs.  Our study population included 
all Medicare LTCH beneficiaries (patients) admitted to LTCHs in March 2014.  
The estimated national incidence rates are limited to events that occurred in 
the first 25 days of the LTCH stay.  The rates are composed of all patient 
harm events regardless of whether they were preventable.  We do not 
provide a cost estimate for these events because we determined that the 
cost methodology used in prior studies would not yield useful results.  
LTCHs provide acute-level services so transfers to other acute-care facilities 
are typically unnecessary and patients are often admitted with complex 
diagnoses and comorbidities, such that the Medicare payment classification 
is unlikely to be changed as the result of a patient harm event.  Other cost 
methodologies would require the collection of additional information from 
providers or beneficiaries. 
 
 
 
21 AHQR, PSNET Patient Safety Primer: Reporting Patient Safety Events.  Updated June 2017.  
Accessed at https://psnet.ahrq.gov/primers/primer/13/reporting-patient-safety-events on 
April 16, 2018. 
22 CMS, LTCH Quality Public Reporting.  Accessed at https://www.cms.gov/Medicare/Quality-
Initiatives-Patient-Assessment-Instruments/LTCH-Quality-Reporting/LTCH-Quality-Public-
Reporting.htm l on February 20, 2018. 
23 P.L. 111-148  3004(a). Social Security Act,  1886(m)(5).  
24 Fed. Reg. 51475, 51743-51756, 51839-51840 (August 18, 2011).  
25 IMPACT Act of 2014, P.L. 113-185  2(a) and 2(3)(c),  Social Security Act,  1899B and 
1886(m)(5).  
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Sample Selection and Profile 
Using Medicare claims data from the National Claims History file, we 
selected a simple random sample of 600 Medicare beneficiaries out of the 
11,460 beneficiaries who began LTCH stays in March 2014.  We excluded 
13 beneficiaries from the selected sample (7 beneficiaries with no Medicare 
payment, 5 beneficiaries from hospitals that were currently under OIG 
investigation, and 1 beneficiary with insufficient documentation).  As a result, 
the reviewed sample consisted of 587 beneficiaries who had a total of 
588 LTCH stays.  The average length of stay was 26.3 days. 
Data Collection 
We requested complete medical records for the sampled beneficiaries 
LTCH stays.  As part of this request, we asked administrators to provide key 
documents, including pre-admission screening documentation and post-
admission physician evaluation.  Because the longest LTCH stays can last 
years, we limited our review and only counted events that occurred during 
the first 25 days of the stay, which is the minimum average length of stay 
required for facilities to be classified as LTCHs.  We applied the 25-day limit 
during the clinicians reviews and it was not a factor in the sample selection.   
Identification of Adverse Events and Temporary Harm Events.  We 
conducted a two-stage medical record review to identify adverse events 
and temporary harm events in the sampled records.  (See Appendix A for a 
detailed description of the medical record reviews and Appendix B for a 
glossary of selected clinical terms used to describe events.)   
The first stage was a screening process using a modified version of the 
Global Trigger Tool (GTT) methodology designed by IHI to identify 
Medicare LTCH patients who may have experienced events.26  Two 
registered nurses used a trigger tool to review the medical records (see 
Appendix C for a list of the triggers used to identify events).  The screeners 
identified the records of 326 beneficiaries who were likely to have 
experienced events.  
In the second stage, physicians reviewed the medical records of the 
326 beneficiaries identified by nurses as likely to have experienced adverse 
or temporary harm events.  Physicians examined the records to identify 
events and described them using a structured data collection instrument.  
Physicians used a guidance document to improve consistency.  
The physician panel included seven physicians who participated in our prior 
studies of acute-care hospitals, SNFs, and rehab hospital events (specialists 
in cardiology, infectious disease, internal medicine, orthopedics, surgery, 
geriatrics, neurology, and physiatry) and an LTCH physician who was also a 
Certified Medical Director accredited by the Society for Post-Acute and 
Long-Term Care Medicine.  The physician reviewers also consulted with a 
 
26 F.A. Griffin and R.K. Resar, IHI Global Trigger Tool for Measuring Adverse Events (Second 
Edition), Institute for Healthcare Improvement Innovation Series 2009. 
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  5 
OEI-06-14-00530   
geriatric psychiatrist and a pulmonologist/intensivist in particularly difficult 
cases. 
Assessment of severity.  The physician reviewers assigned each event to 
one of five harm levels using a modified version of the National 
Coordinating Council for Medication Error Reporting and Prevention Index 
for Categorizing Medication Errors (NCC MERP Index).  We distinguish 
between adverse events (levels F-I on the index) and temporary harm 
events (level E on the index) to separately identify events that were more 
likely to affect cost and length of stay.  Both types of events represent harm 
to patients resulting from medical care.  (See Exhibit 1.) 
Exhibit 1: Modified Version of the NCC MERP Index for Categorizing 
Errors Used in the OIG Study of Adverse Events in LTCHs 
Event Type  Level  Description 
Harm occurred that may have contributed to or 
I 
resulted in the patients death. 
Harm occurred that required intervention to 
H 
sustain the patients life. 
Adverse  Harm occurred that contributed to or resulted in 
Event  G 
permanent patient harm. 
Harm occurred that prolonged the LTCH stay, 
became primary reason for treatment, or resulted 
F 
in transfer to another hospital for observation, 
emergency treatment, or inpatient care. 
Temporary  Harm occurred that caused temporary harm that 
E 
Harm   required intervention. 
Source: Adapted from the  NCC MERP Index for Categorizing Errors.  Revised February 20, 2001.    
Assessment of preventability.  The physician reviewers assigned each 
event to one of five preventability determinationsclearly preventable, 
likely preventable, likely not preventable, clearly not preventable, or unable 
to determine.  They selected a rationale for each preventability 
determination from a list of 16 options, which, among other options, 
included the provision of appropriate treatment or preventive care in a 
substandard way (preventable) and patient experienced the event despite 
efforts by staff to avoid harm (not preventable).  An OIG-developed 
algorithm was also available to guide physicians on difficult preventability 
decisions. 
Data Analysis 
We analyzed the medical review results and generated estimates of event 
incidence and preventability.  We projected the findings to the population 
of an estimated 11,212 Medicare beneficiaries admitted to LTCHs during 
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  6 
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March 2014.27  We calculated the incidence rates as the percentage of 
beneficiaries in the sample who experienced at least one harm event.  For 
estimates and corresponding 95-percent confidence intervals, see 
Appendix D. 
As an additional measure, we calculated two ratios of incidence density: 
events per 1,000 patient days and events per 100 hospital admissions.28  
These measures are commonly used by hospitals and medical researchers.29  
See Appendix E for further explanation of the calculation method.  
Limitations 
These results, as with all medical record reviews, are subject to physician 
interpretation and clinical judgment.  Additionally, it is unlikely that the 
reviewers identified all adverse events and temporary harm events within 
our sample of Medicare beneficiaries in LTCHs.  First, the scope of the 
medical record review included only the first 25 days of LTCH stays.  Any 
harm that occurred after the 25th day was not included in the results.  
Second, all medical record reviews are dependent on available 
documentation.  Omitted information could lead reviewers to miss some 
events or assess the preventability differently.   
Finally, the GTT screening methodology used in the first stage of the review 
is not a comprehensive medical review.  Some events may be missed 
because the screeners are focused on a particular set of triggers.  Analysis in 
a prior OIG study found that compared to a comprehensive medical review 
by physicians, the GTT screening methodology identified 93 percent of the 
patients with events.30 
Standards  This study was conducted in accordance with the Quality Standards for 
Inspection and Evaluation issued by the Council of the Inspectors General on 
Integrity and Efficiency. 
   
 
27 The sample was selected from a population of 11,460 Medicare beneficiaries admitted to 
LTCHs during March 2014.  The projected population of 11,212 beneficiaries accounts for 
beneficiaries in our sample that were excluded from the review.  The 95-percent confidence 
interval for this estimated population is (11,08111,342).  
28 To be consistent with the overall incidence of event, we limited the length of stay to 
25 days in the incidence density calculation. 
29 K.M. Arias, Outbreak Investigation, Prevention, and Control in Health Care Settings: Critical 
Issues in Patient Safety, Second Edition, Jones and Bartlett Publishers, 2009, pp. 330-331. 
30 OIG, Adverse Events in Skilled Nursing Facilities: National Incidence Among Medicare 
Beneficiaries, OEI-06-11-00270, February 2014. 
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FINDINGS 
Twenty-one  One in five Medicare patients (21 percent) experienced adverse events 
during their stays in LTCHs.  These events resulted in harm within the four 
percent of 
most serious categories (F-I) on our modified NCC MERP Index and 
Medicare patients 
represent both preventable and not preventable events.  The majority 
had adverse events  (53 percent) of adverse events experienced by patients caused F level harm 
during their LTCH  (meaning it prolonged the LTCH stay, became the primary reason for 
treatment, or required transfer to another facility.)  Over 40 percent resulted 
stays 
in the need for life-saving intervention (21 percent) or contributed to death 
(20 percent), and the final 6 percent of events contributed to permanent 
harm.  See Exhibit 2.  We estimate that a total of 2,388 Medicare patients 
experienced at least one adverse event during the study period.  Seventeen 
percent of these patients experienced more than one adverse event.  See 
Appendix F for a list of the 456 events in our sample with detailed 
descriptions and levels of harm.   
Exhibit 2: Adverse Events by Level of Harm (n=150) 
Percentage of 
Level of Harm 
Adverse Events 
F level: Prolonged the LTCH stay, became primary reason for  53% 
treatment, or required transfer to another facility 
G level: Contributed to or resulted in permanent patient harm  6% 
H level: Required intervention to sustain the patients life  21% 
20% 
I level: Contributed to or resulted in patient death 
Source: OIG analysis of LTCH stays for 587 Medicare patients entering an LTCH in March 2014.  
Adverse events most often related to healthcare-acquired infections 
(45 percent) with 31 percent related to the use of medication, and the 
remaining 23 percent related to general patient care.31  See Exhibit 3 for the 
types of adverse events within each category.   
Respiratory infections were the most common type of adverse event.32  One 
event involved a patient admitted to the LTCH with respiratory failure.  The 
patient was on a ventilator and had a surgically-created opening in the 
throat to allow the passage of air.  Well after admission, the patient began 
showing signs of a lower respiratory tract infection (tracheobronchitis), with 
 
31 The percent of healthcare-acquired infection adverse events was significantly higher than 
that of medication-related adverse events (p<0.05) and patient care related adverse events 
(p<0.001). 
32 The percent of patients with respiratory infections is significantly higher than the second 
most common type of event in the sample, bleeding associated with anticoagulants 
(p<0.001). 
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OEI-06-14-00530   
a respiratory culture and chest x-ray confirming the diagnosis.  Providers 
waited over a week to begin appropriate treatment with antibiotics, and it 
took several additional days to get the infection under control.  The long-
standing infection ultimately damaged the patients kidneys and contributed 
to a dangerously high potassium level.   
Another adverse event also involved a delay in care as the staff failed to 
identify signs of sepsis.  The patient, who entered the LTCH with chronic 
congestive heart failure and renal syndrome, complained in the morning of 
abdominal distention and nausea, and had an abnormally low oxygen 
reading.  The patient did not receive treatment and developed signs of 
severe sepsis that evening, including an acute change in mental status.  The 
patient died of sepsis several hours later. 
Exhibit 3: Adverse Events Were Most Often Related to Healthcare-Acquired Infections  
(n=150) 
Types of Adverse Events  Percentage of Events* 
Adverse Events Related to Infections  45% 
 LTCH-acquired respiratory infections   23% 
 Sepsis not associated with another event  7% 
 Vascular-catheter associated infections   5% 
 Clostridium difficile infections  3% 
 Surgical site infections   3% 
 Urinary tract infections associated with urinary catheters  2% 
 Other infection-related adverse events  3% 
Adverse Events Related to Medication  31% 
 Bleeding associated with anticoagulants  9% 
 Hypoglycemic events  9% 
 Delirium and other changes in mental status   6% 
 Fluid, electrolyte, and metabolic disorders  3% 
 Acute kidney injury or insufficiency  2% 
 Other medication-related adverse events  3% 
Adverse Events Related to Patient Care  23% 
 Respiratory issues other than infections, such as aspiration  5% 
 Venous thromboembolisms, deep vein thrombosis, or pulmonary embolisms  5% 
 Bleeding not associated with anticoagulants  3% 
 Pressure ulcers  3% 
 Fluid, electrolyte, and metabolic disorders (not medication related)   2% 
 Other patient care events  6% 
Total  100% 
Source: OIG analysis of LTCH stays for 587 Medicare patients who entered an LTCH in March 2014.  
*The total does not equal 100 percent due to rounding. 
 
 
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Five percent of Medicare LTCH patients experienced adverse 
events that contributed to or resulted in their deaths 
These I-level events project to an estimated 573 deaths during the study 
period.  The patients who experienced events that contributed to deaths 
suffered from serious and unresolved medical conditions, including cancer, 
morbid obesity, dementia, renal failure, and diabetes.  Physician reviewers 
reported that many entered the LTCH with a poor prognosis.   
In many cases, the patients had serious conditions that, while not directly 
related to the event, caused their health to be more fragile.  One 
65-year-old patient had several serious health problems, including a 
tracheostomy (surgically-created opening in the throat to allow the passage 
of air) placed following surgery for esophageal cancer, and developed fatal 
septic shock as a result of an infected Stage 4 pressure ulcer.  Another 
patient with a recent relapse of leukemia died from a bacterial infection 
(meningoencephalitis) that resulted in fluid in the brain after staff were slow 
to recognize the infection despite the patient exhibiting confusion and 
fevers, and with laboratory results showing evidence of infection.      
Five percent of Medicare LTCH patients experienced adverse 
events that resulted in transfer to an acute-care hospital, 
emergency department, or another specialty care provider 
An estimated 554 LTCH patients were transferred to other facilities as the 
result of an event during our study period.  For each event that resulted in a 
transfer, physicians assigned a severity rating of F-level harm or higher.  
One of the transferred patients in our sample was a 69-year-old man whose 
urethra was injured while staff changed his urinary catheter.  The injury led 
to urinary retention and significant blood loss.  Due to the degree of harm 
and complexity of the needed treatment, the patient was transferred to an 
acute-care hospital for a blood transfusion and further management.  In 
another case, a patient with multiple chronic conditions and on blood 
thinning medication developed bleeding around the brain (subdural 
hematoma) over a 24-hour period.  The patient was transferred to an acute-
care hospital for surgery to relieve pressure on the brain, a procedure that 
the LTCH was not equipped to perform. 
 
In addition to the 21 percent of patients who experienced adverse events, 
An additional 
25 percent of Medicare patients in LTCHs experienced temporary harm 
25 percent of 
events.  These events were classified as E-level harm on the NCC MERP 
Medicare patients  Index, which is defined as harm events that required intervention but did 
had temporary  not prolong the LTCH stay, necessitate higher levels of care, require 
life-sustaining intervention, or result in lasting harm.  We estimate that 
harm events during 
2,770 LTCH patients experienced at least 1 temporary harm event during the 
their LTCH stays 
study month.  Of these patients, 1,108 had more than 1 unrelated event.  
Additionally, 39 percent of patients who experienced an adverse event also 
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had temporary harm events during their stays.  As with adverse events, 
temporary harm events represented a wide array of conditions from the 
three clinical categories (see Exhibit 4 for the types of temporary harm 
events within each category). 
   Exhibit 4: Temporary Harm Events Were Most Often Related to Medication (n=306) 
Types of Temporary Harm Events  Percentage of Events 
Temporary Harm Events Related to Medication  49% 
 Hypoglycemic events  17% 
 Delirium and other changes in mental status   10% 
 Bleeding associated with anticoagulants    5% 
 Constipation, obstipation, or ileus    5% 
 Acute kidney injury or insufficiency    3% 
 Allergic reactions    3% 
 Other medication-related temporary harm events    5% 
Temporary Harm Events Related to Infection  26% 
 Soft tissue or other nonsurgical infections  9% 
 Thrush (fungal infection of the mouth or throat)  4% 
 Urinary tract infections associated with urinary catheters  4% 
 Clostridium difficile infection   3% 
 LTCH-acquired respiratory infections   3% 
 Other infection-related temporary harm events  4% 
Temporary Harm Events Related to Patient Care  25% 
 Pressure ulcers  7% 
 Bleeding not associated with anticoagulant  3% 
 Venous thromboembolisms, deep vein thrombosis, or pulmonary embolisms  3% 
 Skin tears, abrasions, or breakdowns  3% 
 Falls with injury  2% 
 Other patient-care-related temporary harm events  6% 
Total  100% 
Source: OIG analysis of LTCH stays for 587 Medicare patients entering an LTCH in March 2014. 
Half of the temporary harm events (49 percent) related to the use of 
medication.  These harm events included delirium, excessive bleeding due 
to anticoagulants, and allergic reactions.  Episodes of hypoglycemia 
(abnormally low blood sugar) are categorized as medication events because 
maintaining appropriate blood sugar levels in diabetics relies on insulin and 
oral anti-diabetic medication management.  These episodes were the most 
frequently occurring temporary harm events and accounted for 17 percent 
of temporary harm events overall.33  The remaining temporary harm events 
related to infections (26 percent), such as soft tissue infections and 
 
33 The percent of hypoglycemia temporary harm events was significantly higher than the 
second most common type of temporary harm event, delirium and other changes in mental 
status (p<0.05). 
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catheter-associated urinary tract infections, and patient care events 
(25 percent), such as pressure ulcers and falls resulting in injury.   
Although many cases of temporary harm within the sample represented 
instances of fairly minor harm to the residents, other temporary harm events 
caused harm that was significant for the residents.  We did not classify these 
events as adverse events because they did not prolong the LTCH stays, 
necessitate higher levels of care, require life-sustaining intervention, or 
result in lasting harm.  Physician reviewers indicated that many temporary 
harm events could have developed into more serious events if LTCH staff 
had not provided a timely intervention.  For example, 40 percent of the 
hypoglycemic temporary harm events had documentation of blood glucose 
levels lower than 40 milligrams.  Blood glucose levels under 70 are 
considered low and often require an adjustment to insulin or diabetic 
medication.  If left untreated, severe hypoglycemia can lead to seizures, 
coma, and even death.34  
In one event in our sample categorized as a patient care-related temporary 
harm, an LTCH patient experienced an overload of intravenous fluid, which 
resulted in difficulty breathing and triggered an episode of congestive heart 
failure.  Another patient was treated for a blood clot (deep venous 
thrombosis) after placement of a central line catheter (catheter used for 
long-term administration of medication) resulted in arm swelling.  In each of 
these cases, LTCH clinical staff acted to ameliorate the harm before it could 
result in more serious injury.  
 
Longer stays in  With 46 percent of Medicare patients experiencing either adverse or 
temporary harm events, the incidence of harm in LTCHs is higher than the 
LTCHs present more 
OIG identified in other healthcare settings, including acute-care hospitals 
opportunities for 
(27 percent), SNFs (33 percent), and rehab hospitals (29 percent).35  
adverse events and  However, in comparing harm rates across settings, it is important to note 
temporary harm  that patients in LTCHs have longer lengths of stay on average than patients 
in acute-care hospitals, SNFs, or rehab hospitals.  These longer lengths of 
events 
stay result in more medical interventions over time and, therefore, more 
opportunities for harm to occur.  The average length of stay for the LTCH 
patients in our sample was 26.3 days.  In comparison, average lengths of 
stay for samples in similar OIG studies were 5.2 days in acute care hospitals, 
15.5 days in SNFs, and 12.7 days in rehab hospitals. 36 
 
34 American Diabetes Association, Hypoglycemia (Low Blood Glucose).  Accessed at 
http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-
control/hypoglycemia-low-blood.html on March 30, 2018. 
35 The incidence rate in LTCHs was statistically different from each of the other settings 
reviewed (i.e., acute-care hospitals, SNFs, and rehab hospitals, p<0.0001).  
36 The samples were taken from different months and years.  The sample for acute-care 
hospitals was drawn from October 2008; the sample for SNFs was drawn from August 2011; 
and the sample for rehab hospitals was drawn from March 2012. 
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Using a different metric to measure the frequency of events, the rate of 
events in LTCHs looks more comparable to other post-acute settings (SNFs 
and rehab hospitals) and lower than acute-care hospitals.  Incidence density 
is a metric often used by healthcare facilities to track performance, and is 
defined as the number of events per 1,000 patient days.  We found that the 
incidence density in LTCHs was 38 adverse events and temporary harm 
events per 1,000 patient days.  Prior OIG reports found that patients 
admitted to acute-care hospitals experienced a significantly higher number 
of events per day, with 69 events per 1,000 patient days and that Medicare 
patients in rehab hospitals and SNFs experienced fewer events per 
1,000 patient days (29 events in rehab hospitals and 24 events in SNFs) than 
LTCHs (38 events).37, 38  See Exhibit 5. 
Exhibit 5: Medicare LTCH patients experience more events per patient day 
than patients in other post-acute care settings, but less than acute-care 
hospitals. 
LTCH Medicare patients experienced about 38 adverse events and temporary 
harm events per 1,000 patient days. 
 
Sources: OIG analysis of LTCH stays for 587 Medicare patients entering an LTCH in March 2014; and 
reported statistics from OIG reports OEI-06-09-00091, OEI-06-11-00270, and OEI-06-14-00110. 
Compared with acute-care hospitals, the lower number of events per day in 
LTCHs may be attributable to differences in the patient populations and the 
care provided.  Acute-care hospitals treat sudden and often urgent illnesses 
and injuries and, therefore, are more likely to perform surgical and other 
procedures that can put patients at risk.  Although LTCHs treat medically 
complex and high acuity patients, clinicians and staff may have more 
opportunity to become familiar with their patients conditions, owing to 
their longer stays, which may result in care that is better-suited to the 
patients and less likely to result in harm events.  For more information about 
incidence density in LTCHs, see Appendix E. 
 
37 The incidence density in LTCHs was statistically different from rehab hospitals (p<0.01) and 
SNFs (p<0.0001). 
38 The incidence density in LTCHs was statistically different from acute-care hospitals, 
p<0.0001). 
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Almost one-quarter (22 percent) of Medicare LTCH patients 
experienced more than one unrelated event 
Physicians determined that these harm events were not cascade events 
wherein one event led to another, but were separate events unrelated to 
other harm experienced by the patient.  In some cases, the patients 
experienced the same type of event on more than one occasion, and in 
other cases the events were completely dissimilar and involved different 
conditions, factors, and harm levels.   
In one case, a patient experienced five events during a single LTCH stay, 
with the fifth event ultimately leading to the patients death.  The 
76-year-old patient was admitted to the LTCH for antibiotic therapy and 
physical therapy following an ankle fracture.  First, the patient became ill 
upon starting medication to treat an exacerbation of chronic obstructive 
pulmonary disease (COPD).  Second, the patient developed oral thrush 
(fungal infection of the mouth) as a result of antibiotics.  Third, the patient 
became lethargic as a result of a hypoglycemic event with a blood glucose 
of 38.  Fourth, days after the prior events, the patient aspirated during a 
feeding and developed pneumonia associated with the aspiration.  Fifth, the 
patient contracted a blood stream infection from a central line catheter 
used for long-term administration of the patients antibiotics.   
As the patients medical condition declined, he was transferred to an 
intensive care unit within the LTCH, but began having difficulty breathing 
and became difficult to arouse.  The LTCH pulmonologist recommended 
intubation, but after several failed attempts, the patient was transferred to 
an acute-care hospital and later died.  
 
Over half of  The incidence rates for adverse events and temporary harm events include 
both preventable and not preventable events, but physician reviewers also 
adverse events and 
assessed each event to determine whether it could have been prevented.  
temporary harm 
Using the documentation in the medical records, they determined that over 
events were  half of adverse events and temporary harm events (54 percent) were clearly 
or likely preventable and that most of the remaining events (45 percent) 
preventable 
were clearly or likely not preventable.  Physicians were unable to make a 
determination for the remaining one percent of events because of 
incomplete documentation or complexities in the patients conditions.  If we 
were to include only preventable events in the incidence rates, the percent 
of Medicare patient in LTCHs that experienced preventable adverse events 
would be 14 percent (rather than 21 percent) and the percent of patients 
that experienced preventable temporary harm events would also be 14 
percent (rather than 25 percent).  Event-specific preventability assessments 
are included in Appendix F. 
 
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Adverse events were more likely to be preventable than temporary harm 
events (62 percent of adverse events were preventable versus 50 percent of 
temporary harm events).39  Exhibit 6 presents the percentage of events 
within each category of preventability.   
Exhibit 6: Adverse Events and Temporary Harm Events by Preventability 
Determination (n=456) 
Percentage of All 
Preventability Assessment 
Events 
PreventableHarm could have been avoided through improved 
54% 
assessment or alternative actions 
       Clearly preventable  7% 
       Likely preventable  47% 
Not PreventableHarm could not have been avoided given the 
45% 
complexity of the patients condition or care required 
       Likely not preventable  42% 
       Clearly not preventable  3% 
Unable to Determine Preventability  1% 
Source: OIG analysis of LTCH stays for 587 Medicare patients admitted in March 2014. 
Preventable events were often related to substandard care and 
medical errors   
Physician reviewers determined that over half (58 percent) of preventable 
events affecting Medicare patients in LTCHs involved clinicians providing 
appropriate treatment or preventive care, but in a substandard way, and 
one-third (34 percent) related to errors in medical judgment, skill, and 
management.  One medical error involved a patient that developed blood 
clots (bilateral deep venous thrombosis) after the physician failed to sign a 
standard authorization for prophylactic blood thinning medication and it 
was never provided.   
Another medical error occurred as LTCH clinicians over-medicated a patient 
who was suffering from volume overload (a condition in which there is too 
much fluid in the body).  A nephrologist on site recorded that the patient 
received too much diuretic medication, used to rid the body of excess fluid, 
which resulted in dehydration and acute kidney injury.  See Exhibit 7 for a 
full list of the preventability rationales cited by physician reviewers for 
preventable events. 
 
 
 
39 The difference between adverse events and temporary harm events for preventability was 
statistically significant at the 95-percent confidence interval (p<0.05). 
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Exhibit 7: Rationales for Events Determined Preventable (n=245) 
  Percentage of 
Rationales for Preventable Events 
Preventable Events* 
Substandard treatment / preventive care  58% 
Error was related to medical judgment, skill, management  34% 
The patients progress was not adequately monitored  25% 
Patient care plan was inadequate  23% 
Clinicians did not provide necessary treatment  18% 
Equipment failure or other breakdown  3% 
Poor communication among caregivers  2% 
Lack of access to a physician or specialist  2% 
Admission assessment was inadequate for the patient  2% 
Other  12% 
Source: OIG analysis of LTCH stays for 587 Medicare patients who entered an LTCH in March 2014.  
*Reviewers often selected more than one rationale per event. 
 
Hypoglycemic events were the most frequently occurring type of 
preventable event40, with physician reviewers classifying 71 percent of all 
hypoglycemic events as preventable.  Medicare patients in LTCHs exhibited 
a high incidence of diabetes, requiring providers to actively manage their 
blood glucose levels.  Among patients who were diabetic (42 percent), 18 
percent experienced a hypoglycemic event.   
Physician reviewers noted that in several cases, hypoglycemic events related 
to the providers reliance on sliding-scale insulin therapy.  Sliding-scale 
insulin therapy is a medication regimen that adjusts the dose of insulin 
ordered based on the measured blood glucose level.  It attempts to correct 
abnormal blood glucose levels after they occur, rather than preventing the 
abnormal levels before they occur.  Although it is still common practice, its 
exclusive use is discouraged by current clinical practice guidelines because it 
is associated with unsafe fluctuations in blood glucose levels.41   
As previously stated, most of the patient deaths in our sample involved 
patients with multiple serious health conditions, making the care very 
complex.  In a few cases, though, events were clearly preventable.  One 
event involved a 91-year-old patient with end-stage renal disease and a 
recent hospital admission for sepsis, who entered an LTCH for ongoing care 
that included intravenous antibiotics.  The patient had severe and 
 
40 The percent of preventable hypoglycemic episodes was significantly higher than the 
second most common type of preventable event, delirium and other changes in mental 
status (p<0.05). 
41 The American Medical Directors Association, the American Association of Clinical 
Endocrinologists and the American College of Endocrinology recommend the use of 
multi-modal (basal, prandial, and correctional) insulin instead of sliding-scale insulin in 
noncritically ill adult patients. 
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unrecognized hypothyroidism, suffering from a low body temperature, low 
blood pressure, and decreased mental status, along with a significantly 
abnormal thyroid test.  Yet the patients thyroid replacement medication 
was dosed too low and not increased until 4 days before the patients 
death.  Physician reviewers determined that the diagnostic and therapeutic 
interventions were insufficient in identifying and addressing this patients 
condition.   
Patient susceptibility or poor health status was a factor in most 
(81 percent) of the events that were not preventable 
Eighty-one percent of the events physician reviewers identified as not 
preventable were associated with patients who were highly susceptible to 
the events or in particularly poor health.  Patients in LTCHs are often 
extremely debilitated and require high levels of care from a range of 
specialists, increasing their exposure to medical interventions.  Many had a 
poor prognosis and required acute level patient care for an extended time.   
In one event assessed as not preventable, the patient experienced a wound 
infection at the site of a prior post-operative drain site on the 
abdomen.  During the preceding acute-care hospitalization, the patient 
underwent a colectomy (removal of part of the colon) for diverticulosis 
(pouches in the wall of the colon), followed by a complicated course with 
multiple extensive surgeries on the colon that resulted in sepsis from an 
anastomotic leak (breakdown of a surgical connection) with widespread 
contamination. The physician reviewer considered this patient to be highly 
susceptible to the infection during the subsequent LTCH stay because of the 
anastomotic leak during the prior hospitalization that had resulted in 
contaminated feculent fluid in the area.  Exhibit 8 provides the most 
common preventability rationales cited by the reviewers for all events 
determined not preventable. 
Exhibit 8: Rationales for Events Determined Not Preventable (n=206) 
Rationales for   Percentage of Not 
Not Preventable Events  Preventable Events* 
Patient was highly susceptible to event because of health status  81% 
Patients diagnosis was unusual or complex, making care difficult  36% 
Event occurred despite proper assessment and procedures followed  24% 
Care provider could not have anticipated event with information available at the time  12% 
Harm was anticipated but was considered acceptable given alternatives  12% 
Other  4% 
Source: OIG analysis of LTCH stays for 587 Medicare patients who entered an LTCH in March 2014.  
*Reviewers were allowed to select more than one rationale per event. 
 
 
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For other events determined not preventable, the patients diagnosis or 
treatment was unusual or complex, making care difficult (36 percent of not 
preventable events).  One such event involved a young patient who was 
paraplegic with multiple wounds, a bone infection, a blood clot (deep 
venous thrombosis), and a urinary tract infection.  The patient was receiving 
antibiotics through a central line catheter designed for long-term use: a 
peripherally inserted central catheter (PICC) line.  LTCH staff discovered the 
patient contaminating his own line (using a syringe to inject crushed up pain 
medication into the PICC line).  The patient later developed a fungal 
infection of the bloodstream. 
In other cases, the potential for harm was known, but the harm was 
considered acceptable given the alternative of not providing care 
(12 percent of not preventable events).  One event that was not preventable 
involved a patient on blood thinning medication who experienced recurrent 
urinary retention.  The retention necessitated placement of a urinary 
catheter, which led to the patient hemorrhaging and requiring a blood 
transfusion.  Reviewers determined the event was likely not preventable 
because, if left untreated, the urinary retention could have led to sepsis or 
kidney injury.   
     
 
   
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CONCLUSION AND RECOMMENDATIONS 
Prior OIG reports demonstrated that adverse  events and temporary harm 
events are common in many healthcare settings, endanger patient health, 
and result in  a significant financial cost to Medicare.  Almost half of 
Medicare patients in LTCHs experienced harm, more than OIG measured in 
acute-care hospitals, SNFs, and inpatient rehab hospitals.  This higher rate 
of patient harm may be due, in part, to longer stays and high patient acuity.   
However, reviewers also found that over half of the harm was preventable 
and many events were the result  of medical error.   Providers and overseers 
should follow evidence-based practices and use systems-based approaches 
to prevent patient harm and ensure that LTCH patients receive an 
appropriate standard of care.  Researchers also should continue to identify 
and promote safe practices in the LTCH setting. 
In our prior reports about  adverse events, we  made a series of 
recommendations to AHRQ, the coordinating body for healthcare quality 
improvement, and to CMS, the largest healthcare payer and Federal 
overseer of patient safety and CoP compliance in LTCHs.  In  response, 
AHRQ and CMS took important steps to raise awareness of adverse events 
and to reduce harm to patients.  In 2011, CMS introduced its Partnership for 
Patients initiative, a public and private  collaboration to improve healthcare 
quality and safety, including during transitions from acute to post-acute 
care.  CMS also finalized a tool for hospital surveyors to assess QAPI 
programs in 2014, and compiled resources and information about adverse 
events and temporary harm events at a website specific to SNF resident 
safety.   
AHRQ and CMS should tailor their ongoing efforts to improve patient safety 
to address the specific needs of LTCHs.  Although LTCHs provide acute-level 
services and are required to meet the same Federal requirements as 
acute-care hospitals, they  serve a population that typically requires 
high-acuity care for longer periods of time.  These patients have an 
increased exposure to medical interventions and, therefore, an  increased 
risk of harm.  AHRQ and CMS should  attend to  the unique needs and 
vulnerabilities associated with this setting.   
We recommend:  
AHRQ and CMS should collaborate to create and disseminate a 
list of potential adverse events in LTCHs  
Identification of patient harm is critical to the success of patient safety 
efforts, providing facility staff the information to correct problems and 
reduce harm.  Our physician review of medical records found that many 
events were  the result of substandard care or medical errors.  They  also  
found that Medicare patients in LTCHs were particularly susceptible to some 
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries   19  
OEI-06-14-00530   
types of harm.  AHRQ and CMS should seek appropriate opportunities 
within their existing programs to raise awareness of the types of harm 
events that occur in LTCHs.  
In response to OIG recommendations in earlier reports about adverse 
events in acute-care hospitals, SNFs, and rehab hospitals, AHRQ and CMS 
collaborated to create lists of potentially reportable adverse events.  The 
lists are in various stages of review and use, but have been used by the 
agencies and facilities to inform providers, measure performance, and/or to 
promote safety.  Such a list could also be used as a resource for educating 
LTCH staff about patient safety and developing ways to measure facility 
performance.  AHRQ and CMS should expand these efforts to provide 
information about adverse events and temporary harm events in LTCHs.  
This list could be an addendum to the list of acute-care hospital events or a 
stand-alone document specific to LTCHs.   
This study identified a high rate of harm, illustrating not only common 
events but representing a broad range of potential harm that occurred in 
this complex patient population.  AHRQ and CMS should use this list to 
highlight the most common types of harm in LTCHs, as well as the broader 
range of events identified in all settings and that providers may not 
routinely consider in safety practices.  Appendix F of this report provides 
descriptions of the events found in our sample, which could serve as a 
starting point for AHRQ and CMS efforts.   
CMS should include information about potential events and 
patient harm in its quality outreach to LTCHs  
CMS efforts to improve safety practices in acute-care hospitals apply to 
LTCHs, but additional education tailored to LTCHs would further promote 
safe care practices and bring attention to the special needs of LTCH 
patients.  The educational correspondence or materials should include a 
definition of adverse events; a list of potential adverse events for staff 
education on the range of harm that patients can experience; 
evidence-based best practices for reducing harm in the LTCH setting; and 
best practices for improving staff identification and reporting of adverse 
events.  Sharing patient safety education tailored to LTCHs will complement 
the efforts underway for acute-care hospitals, SNFs, and rehab hospitals. 
   
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AGENCY COMMENTS AND OIG RESPONSE  
 
CMS and AHRQ concurred with our recommendations.  Both agencies responded 
that they will work collaboratively to create and disseminate a list of potential 
adverse events in LTCHs.  CMS responded that it will include information about 
potential events in its outreach to LTCHs, including newsletters, webpages, and 
technical assistance.  Additionally, CMS described its ongoing efforts to improve the 
quality of care and reduce adverse events in LTCHs, including its oversight of LTCH 
QAPI programs and administration of the LTCH quality reporting program.   
OIG appreciates the agencies concurrence and continued commitment to 
improving patient safety.  Adverse events and temporary harm events are common 
in LTCHs and are often preventable.  It is important that AHRQ and CMS take action 
to include LTCHs in patient safety efforts.  A better understanding of the potential 
for and types of patient harm in LTCHs will assist providers and overseers in 
identifying and reducing patient harm. 
For the full text of the comments, please see Appendix G. 
 
   
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APPENDIX A: Methodology for Identifying 
Events and Determining Preventability  
We conducted a two-stage medical record review to identify adverse events 
and temporary harm events that affected the sampled beneficiaries.  In the 
first stage, two registered nurses (referred to as screeners) identified 
possible patient harm events using a trigger tool methodology and 
flagged the medical records of those patients.  Records flagged by nurses 
were reviewed in the second stage of the medical record review.  The 
second stage included comprehensive medical record reviews conducted by 
one of seven contracted physicians.  Every record was reviewed by a 
screener and, if flagged, reviewed by a physician. 
Stage One: Nurse Review.  To identify beneficiaries who were likely to 
have experienced events during their stays, screeners reviewed medical 
records for the LTCH stays using a trigger tool.  The trigger tool was based 
on the IHI GTT instrument that we modified for the LTCH environment.42  
(See Appendix C.)  The protocol requires screeners to look for triggers that 
indicate possible patient harm.   
A trigger is a clue that may be the result of an event.  It could inherently be 
the harm, such as a pressure ulcer, or a reference that indicates possible 
harm, such as transfer to a higher level of care.  The triggers served as 
alerts, prompting the screeners to explore the records further.  The trigger 
tool also included options to select other if harm was found but was not 
related to a listed trigger.  The screeners used the triggers to find possible 
events, but only flagged the records for which they determined that adverse 
or temporary harm events likely occurred.   
For each possible event, the screeners recorded a description of the event 
and the level of harm.  Of the 587 beneficiaries in the sample, screeners 
flagged 326 beneficiaries records (56 percent) for the second stage of 
review.  The flagged records could include more than one possible event. 
The screening process enabled us to reduce the number of cases requiring 
a comprehensive medical record review by a physician.  As in the other OIG 
studies of adverse event incidence, physician reviewers indicated that the 
results of the stage one screening helped them to readily identify potential 
events for consideration. 
Stage Two: Physician Review.  One of seven physicians reviewed the 
medical records for each of the 326 beneficiaries flagged in the initial 
screening.  The physician reviewers represented a variety of specializations 
and experience, including cardiology, infectious disease, internal medicine, 
 
42 Griffin, Loc. cit. 
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orthopedic surgery, geriatrics, neurology, and physiatry.  One of the 
physicians was an LTCH physician and a Certified Medical Director 
accredited by the Society for Post-Acute and Long-Term Care Medicine.  Six 
of the seven served as physician reviewers in prior OIG studies of adverse 
events.  The physician reviewers also consulted with a geriatric psychiatrist 
and a pulmonologist/intensivist in a few particularly complex cases. 
The physician reviewers conducted thorough reviews of the complete 
medical records and also read other information made available to them 
(e.g., administrative data, hospital discharge summaries from prior 
hospitalizations, and select readmission records).  Physicians independently 
identified adverse events and temporary harm events and also confirmed or 
dismissed the potential events identified by the screeners in the first stage 
of review.  For each event identified, the physician reviewers followed a 
structured protocol that required them to describe the event, the relevant 
evidence and its location in the medical record, the level of harm 
experienced by the patient, and whether the event was preventable.   
Physician Guidance Document.  Physicians used a guidance document to 
assess cases.  The guide provides definitions and considerations for specific 
types of events and includes a list of frequently asked questions.  The guide 
was built using clinical research literature, professional and Government 
guidelines, decisions made in prior OIG studies, and consultations with 
subject-matter experts.   
The guidance also provides instructions that are applicable to a wide range 
of cases, including how to assess event timing, underlying disease, related 
events, and recurring events: 
  Present on admissionWe excluded events that occurred before 
the patient entered the LTCH or were attributable to care provided 
prior to admission. 
  Underlying diseaseWe excluded events that were part of the 
underlying disease.   
  Related eventsWhen an initial event caused a series of related and 
dependent events, we combined the events into a cascade event 
and counted it as a single event.   
  Recurring eventsWhen an event recurred during an LTCH stay 
(e.g., two episodes of hypoglycemia), we considered the timeframe 
and the circumstances of the event.  We counted recurring events as 
a single event if they happened under similar circumstances or were 
less than 7 days apart.  We counted them as separate events if the 
circumstances that led to the events were different or the events 
were more than 7 days apart. 
 
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Assessment of Severity.  As in prior OIG studies, physician reviewers 
assigned each event to one of five levels of harm using a modified version 
of the NCC MERP Index.  The levels ranged between E (temporary harm) 
and I (contributing to death).  (See Exhibit 1 on page 6.)  However, a new 
issue emerged in the LTCH environmentthe distinction between E-level 
temporary harm and F-level adverse events was less clear.  Patients enter 
LTCHs with complex medical issues for an extended time, making it difficult 
to determine whether an event prolonged the length of the stay, and 
because LTCHs provide the same services as acute-care hospitals, serious 
events may not require transfers to other facilities.   
As a result, we revised the definition associated with the F-level of harm.  In 
prior OIG studies, the F-level of harm included events that prolonged the 
stay or required transfer to another facility for observation, emergency 
treatment, or inpatient care.  In this study, we also included events that 
became the primary reason for the patients care as F-level. 
Assessment of Preventability.  The physician reviewers assigned each 
event to one of five preventability determinations and identified factors that 
contributed to the events.  (See the five-point scale in Exhibit A-1.)  
Physicians also selected a rationale for each determination based on a list of 
16 contributing factors gleaned from prior research and experience in OIG 
studies of adverse events. 
Preventability determinations are necessarily subjective and required the 
physicians to use clinical experience and judgment.  Physicians based 
decisions on the circumstances of the specific case and also considered 
accepted standards of care, the expected frequency of certain events, 
guidance developed during the review process, and group discussion of the 
patients and cases. 
Exhibit A-1: Preventability Determinations 
Preventability Determination  Description 
Patient harm could definitely have been avoided through improved 
Clearly Preventable 
assessment or alternative actions. 
Patient harm could likely have been avoided through improved 
Likely Preventable 
assessment or alternative actions. 
Patient harm could likely not have been avoided given the 
Likely Not Preventable 
complexity of the patients condition or the care required. 
Patient harm could definitely not have been avoided given the 
Clearly Not Preventable 
complexity of the patients condition or the care required. 
Physicians were unable to determine preventability because of 
Unable to Determine 
incomplete documentation or case complexity. 
Source: Adverse Events in Long Term Care Hospitals: National Incidence Among Medicare Beneficiaries (OEI-06-14-00530). 
 
 
 
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  24 
OEI-06-14-00530   
Assessing an event as clearly preventable or clearly not preventable required 
a greater degree of certainty on the part of the reviewer.  The expanded 
scale enabled physicians to make more precise determinations, while our 
primary statistics collapse clearly and likely into the larger categories of 
preventable or not preventable.   
Physician reviewers had access to an OIG-developed algorithm to assist with 
difficult preventability decisions. The algorithm consisted of a series of 
questions that led the reviewers to a suggested response.  Questions 
addressed issues such as whether there was a medical error, whether the 
event could have been anticipated, and how frequently the event occurred 
given proper care.  Physicians could use the algorithm to inform their 
decision, but also used their clinical judgment to determine whether the 
suggested response was appropriate in the particular case. 
Consistency Discussions and Quality Assurance Reviews.  To promote 
consistency across physician reviewers, we facilitated 19 conference calls 
during which physician reviewers discussed cases that were complex, 
difficult to assess, involved issues outside their area of expertise, or had 
possible implications for other cases.  The goal of these calls was to reach 
consensus and to establish consistency among the reviewers.  During the 
weekly conference calls, we required physicians to discuss all clearly 
preventable and clearly not preventable determinations and events that may 
have contributed to a patients death.  We also encouraged them to bring 
other cases for discussion at their discretion.  We documented the 
discussions and used the resulting decisions to continually revise our written 
physician guidance document to further promote consistency. 
We also conducted separate quality assurance reviews and discussed any 
inconsistencies with the reviewers.  We compared the identified events, 
harm-level determinations, and preventability determinations across groups 
and looked for deviations from our physician guidance document.  We then 
shared the results with physicians and in some cases, changed 
determinations as a result of the new information and analysis. 
Data Analysis 
We analyzed the results of the review and generated national estimates of 
incidence as well as preventability rates.  For estimates and corresponding 
95-percent confidence intervals, see Appendix D.  
Incidence Analysis.  We estimated the incidence rates as the percentage 
of beneficiaries in LTCHs who experienced at least one harm event within 
the population from which we selected the sample, Medicare beneficiaries 
admitted to LTCHs during March 2014.   
 
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  25 
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As an additional measure, we calculated two ratios of incidence density: 
events per 1,000 patient days and events per 100 hospital admissions.43  
These measures are commonly used by hospitals and medical researchers.44  
See Appendix E for further explanation of the calculation method.  
Preventability Analysis.  We estimated percentages for each 
preventability classification and for different types of events.  We also 
conducted statistical tests to identify significant differences in preventability 
rates between adverse events and temporary harm events and across 
various categories of adverse events, such as medication-related and 
infection-related events at the 95-percent confidence level.  
 
 
   
 
43 To be consistent with the overall incidence of harm events, we limited the length of stay to 
25 days in the incidence density calculation. 
44 K.M. Arias, Outbreak Investigation, Prevention, and Control in Health Care Settings: Critical 
Issues in Patient Safety, Second Edition, Jones and Bartlett Publishers, 2009, pp. 330-331. 
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  26 
OEI-06-14-00530   
APPENDIX B: Glossary of Selected Terms 
Acute kidney injurySudden loss of the kidneys ability to remove waste, 
also referred to as acute renal insufficiency. 
Adverse eventHarm to a patient as a result of medical care or in a 
healthcare setting, including the failure to provide needed care. 
AnticoagulantMedication that hinders blood coagulation, typically used 
to avoid blood clots and referred to as blood-thinning medication. 
ArrhythmiaCondition of abnormal cardiac (heart) rhythm. 
AspirationAccidental inhalation of foreign material into the lungs. 
Congestive heart failureCondition in which the heart is unable to 
maintain adequate circulation of blood in the tissues of the body. 
ConjunctivitisInfection or inflammation of the mucous membrane of the 
eye or eyelid. 
Deep vein thrombosis (DVT)A condition marked by the formation of a 
thrombus (blood clot) within a deep vein (as of the leg or pelvis) that is 
potentially life threatening if dislodgment of the thrombus results in 
pulmonary embolism blocking the pulmonary (lung) artery. 
DeliriumMental disturbance characterized by acute confusion, 
disordered speech, and hallucinations. 
DialysisMedical procedure to remove wastes and toxins from the blood, 
and to adjust fluid and electrolyte imbalances. 
HypoglycemiaCondition of abnormally low blood sugar (glucose) level. 
HypotensionCondition of abnormally low blood pressure. 
IleusPartial or complete obstruction of the bowel, marked by a painful 
distended abdomen, vomiting, toxemia, and dehydration. 
Methicillin-resistant Staphylococcus aureus (MRSA)Bacteria that are 
resistant to many antibiotics.  MRSA can cause a variety of problems 
including skin infections, sepsis, pneumonia, and bloodstream infections. 
ObstipationCondition of severe constipation (abnormally delayed 
passage of dry, hardened feces) that can result in bowel obstruction. 
Percutaneous Endoscopic Gastrostomy (PEG)A procedure in which a 
flexible feeding tube is placed through the abdominal wall and into the 
stomach.  This allows nutrition, fluids, and/or medications to be put directly 
into the stomach, bypassing the mouth and esophagus. 
Peripherally inserted central catheter (PICC)A device used to draw 
blood and give treatments, including intravenous fluids, drugs, or blood 
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  27 
OEI-06-14-00530   
transfusions.  A thin, flexible tube is inserted into a vein in the upper arm 
and guided (threaded) into a large vein above the right side of the heart 
called the superior vena cava.  A needle is inserted into a port outside the 
body to draw blood or give fluids.  A PICC may stay in place for weeks or 
months and helps avoid the need for repeated needle sticks. 
Pressure ulcer/injuryUlceration of tissue deprived of adequate blood 
supply by prolonged pressure, also called decubitus ulcer and bedsore.  
Pressure ulcers/injuries are classified into four stages: Stage 1 is intact skin 
with nonblanchable redness; Stage 2 is a shallow ulcer or blister indicating 
damage to the epidermis; Stage 3 is damage extending through all layers of 
the skin; and Stage 4 is damage through all the layers of the skin and 
underlying muscle, tendons, or bone.45 
Pulmonary embolismObstruction of the pulmonary (lung) artery, often 
marked by shortness of breath; chest pain with inhalation; and, in severe 
cases, low blood pressure and death. 
SepsisSystemic response to a serious, usually localized infection of 
bacterial origin, such as inflammatory response syndrome. 
TachycardiaCondition of rapid heart rate. 
Temporary harm eventHarm to patient that required intervention but 
did not cause lasting harm, classified as E level on patient harm index. 
ThrushInflammation of the mouth and throat, caused by fungus. 
Urinary tract infection (UTI)Infection of the tract through which urine 
passes and can include the kidney, ureters, bladder, and/or urethra. 
Volume overloadCondition in which there is too much fluid in the body, 
such as fluid given intravenously (by vein) at a higher rate or larger volume 
than can be absorbed or excreted. 
 
 
 
   
 
45 Press release: National Pressure Ulcer Advisory Panel (NPUAP) announces a change in 
terminology from pressure ulcer to pressure injury and updates the stages of pressure 
injury.  Accessed at http://www.npuap.org/ on March 8, 2018. 
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  28 
OEI-06-14-00530   
APPENDIX C: LTCH Trigger Tool Worksheet 
The IHI GTT uses triggers to signal possible adverse events and temporary 
harm events.  For this study, OIG and its contracted clinical consultants built 
a trigger tool specific to LTCH stays based on the IHI GTT.  To develop this 
trigger tool, we reviewed and selected triggers from the IHI GTT and from 
among the triggers that were included in prior OIG studies.  We chose 
triggers that the clinicians determined to be most applicable to LTCH stays.  
See exhibit C-1 for the list of triggers used for this study. 
Exhibit C-1: Triggers Listed on the Trigger Tool Worksheet 
Care Module Triggers  Care Module Triggers (continued) 
C1  Acute mental status change  C22  Urinary retention 
C2  Aspiration  C23  New onset diarrhea 
C3  Call to physician or family members  C24  Prolonged constipation or obstipation 
Code, Rapid Response Team, or Emergency 
C4  C25  Diagnostic radiology or imaging studies 
Medical Services 
C5  Death  C26  New or worsening contracture 
Drop in hemoglobin or hematocrit, or 
C6  C27  Transfer to higher level of care within facility 
unplanned transfusion 
Studies for emboli, pulmonary embolism, or 
C7  C28  CareOther 
deep venous thrombosis 
C8  Fall  Medication Module Triggers 
C9  Family complaint  M1  Abnormal electrolytes 
C10  Any infection  M2  Abrupt medication stop 
C11  New or increased diuretics  M3  Anti-emetic use 
C12  High or low body temperature  M4  Diphenhydramine (Benadryl) use 
Elevated international normalized ratio (INR) or 
C13  In LTCH stroke or transient ischemic attack  M5  partial thromboplastin time greater than 100 
seconds 
Glucose less than 50, Glucagon or Dextrose 
C14  New or worsening onset of incontinence  M6 
supplement given 
C15  Insertion or use of urinary catheter  M7  Abrupt onset hypotension 
C16  Patient incident or accident  M8  Naloxone (Narcan) use 
C17  Pressure ulcer  M9  Flumazenil (Romazicon) use 
C18  Emergency department visit  M10  Epinephrine or Norepinephrine use 
Unplanned transfer to acute-care hospital 
C19  (including admission thru emergency  M11  Sodium Polystyrene (Kayexalate administration) 
department or to an observation unit) 
C20  Restraint use  M12  Abnormal drug levels 
C21  Rising serum creatinine or acute dialysis  M13  Thrombocytopenia 
     
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  29 
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Medication Module Triggers (continued)  Medication Module Triggers (continued) 
Total white blood count less than 3000 or 
M14  M20  MedicationOther 
greater than 12,000 
M15  Vitamin K administration (AquaMephyton)  Procedure Module Triggers 
M16  Antibiotics started in LTCH  P1  Postoperative or postprocedure complication 
Procedure intubation, reintubation, 
recanulation, new Bilevel Positive Airway 
M17  Beginning or increasing pain medication  P2 
Pressure (BiPAP), or new Continuous Positive 
Airway Pressure (CPAP) 
Postoperative or postprocedure troponin level 
M18  New administration of parenteral fluid  P3 
of greater than 1.5 ng/ml 
Rising alanine aminotransferase (ALT) / 
M19  aspartate aminotransferase (AST)Liver  P4  ProcedureOther 
Function Test 
Source: Adverse Events in Long Term Care Hospitals: National Incidence Among Medicare Beneficiaries (OEI-06-14-00530). 
 
 
   
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  30 
OEI-06-14-00530   
Appendix D: Estimates, Confidence Intervals, 
and Key Statistics 
The estimates included in this report are based on a sample of 
587 Medicare patients admitted to LTCHs during March 2014.  The resulting 
incidence rates were projected to the population of 11,212.  Below, we 
present the corresponding 95-percent confidence intervals.  See exhibit D-1 
for beneficiary level statistics and exhibit D-2 for event level statistics. 
Exhibit D-1: Beneficiary Level Estimates, Confidence Intervals, and Key Statistics 
95-Percent  95-Percent 
Percentage  Confidence  Confidence 
Sample  of  LowIenrt ervaUl pper  Number of  LowIenrt ervaUl pper 
Estimate Description  Size (n)  Beneficiaries  Bound  Bound  Beneficiaries  Bound  Bound 
Event Experiences for All Beneficiaries 
Experienced at least one 
adverse or temporary harm  587  46.0%  42.1%  49.9%  5,157  4,712  5,602 
event 
Experienced at least one 
preventable adverse or  587  30.0%  26.5%  33.7%  3,362  2,954  3,769 
temporary harm event 
Experienced at least one 
587  21.3%  18.2%  24.7%  2,388  2,024  2,751 
adverse event 
Experienced at least one 
587  13.8%  11.3%  16.8%  1,547  1,241  1,853 
preventable adverse event 
Experienced at least one 
temporary harm event and no  587  24.7%  21.5%  28.3%  2,770  2,386  3,153 
adverse event 
Experienced at least one 
preventable temporary harm  587  14.1%  11.6%  17.1%  1,585  1,276  1,894 
event and no adverse event 
Experienced multiple events  587  21.8%  18.7%  25.2%  2,445  2,078  2,812 
I-level harmExperienced 
adverse event that contributed  587  5.1%  3.6%  7.2%  573  378  768 
to death  
H-level harmExperienced 
adverse event that required 
587  5.1%  3.6%  7.2%  573  378  768 
intervention to sustain the 
patients life  
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  31 
OEI-06-14-00530   
G-level harmExperienced 
adverse event that contributed 
587  1.5%  0.8%  2.9%  172  63  281 
to or resulted in permanent 
patient harm  
F-level harmExperienced 
adverse event that resulted in 
prolonged LTCH stay or  587  11.9%  9.6%  14.7%  1,337  1,050  1,624 
became primary reason for 
treatment  
Transferred to an acute-care 
hospital because of an adverse  587  4.9%  3.5%  7.0%  554  362  746 
or temporary harm event 
Experienced a cascade event  587  7.3%  5.5%  9.7%  821  590  1,052 
Diagnosed with diabetes  587  42.1%  38.2%  46.0%  4,718  4,277  5,158 
Experienced hypoglycemic 
587  9.7%  7.6%  12.3%  1,089  826  1,351 
episode 
Beneficiaries Who Experienced at Least One Adverse Event or One Temporary Harm Event 
Transferred to an acute-care 
hospital as the result of an 
270  10.7%  7.6%  14.9%  554  362  746 
adverse or temporary harm 
event 
Experienced a cascade event  270  15.9%  12.1%  20.7%  821  591  1,052 
Beneficiaries Who Experienced at Least One Adverse Event 
Experienced adverse event 
that contributed to death  125  24.0%  17.5%  32.0%  573  378  768 
(I-level harm) 
Experienced multiple adverse 
125  56.0%  47.4%  64.2%  1,337  1,050  1,624 
or temporary harm events 
Experienced multiple adverse 
125  16.8%  11.3%  24.2%  401  237  566 
events 
Experienced additional 
125  39.2%  31.2%  47.8%  936  691  1,181 
temporary harm event 
Beneficiaries Who Experienced at Least One Temporary Harm Event and No Adverse Events 
Experienced multiple 
145  40.0%  32.5%  48.0%  1,108  844  1,372 
temporary harm events 
Beneficiaries with Diabetes 
Experienced at least one 
adverse event or temporary  247  50.2%  44.1%  56.3%  2,368  2,006  2,731 
harm event 
Experienced at least one 
247  18.2%  14.0%  23.4%  860  624  1,095 
hypoglycemic event 
Source: Office of Inspector General analysis of LTCH stays for 587 Medicare beneficiaries in March 2014. 
 
  
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  32 
OEI-06-14-00530   
Exhibit D-2: Event Level Estimates, Confidence Intervals, and Key Statistics 
95-Percent Confidence 
Interval 
Sample  Lower 
Upper Bound 
Estimate Description  Size (n)   Percentage  Bound 
All Adverse Events and Temporary Harm Events 
Temporary harm event (E-level harm)  456  67.1%  62.6%  71.3% 
Adverse harm event  456  32.9%  28.7%  37.4% 
        F-level harmProlonged LTCH stay or hospital    
456  17.3%  14.1%  21.1% 
        admission 
        G-level harmPermanent patient harm  456  2.0%  1.1%  3.6% 
        H-level harmLife-sustaining intervention  
456  7.0%  5.0%  9.8% 
        required 
        I-level harmContributing to or resulting in  
456  6.6%  4.7%  9.2% 
        death 
Cascade event  456  9.6%  7.3%  12.6% 
Resulted in transfer to an acute-care hospital   456  7.0%  5.0%  9.9% 
Clinical Category for All Adverse Events and Temporary Harm Events 
Medication adverse and temporary harm event  456  43.2%  38.9%  47.6% 
        Medication-related adverse event   197  10.1%  7.6%  13.2% 
        Medication-related temporary harm event   197  32.9%  28.9%  37.1% 
Infection adverse and temporary harm event  456  32.7%  28.8%  36.8% 
        Infection-related adverse event   149  14.9%  12.0%  18.3% 
        Infection-related temporary harm event   149  17.8%  14.5%  21.6% 
Patient care adverse and temporary harm event  456  24.1%  20.6%  28.0% 
        Patient-care related adverse event   110  7.7%  5.6%  10.4% 
        Patient-care related temporary harm event   110  16.4%  13.4%  20.1% 
Level of Harm and Preventability for Adverse Events 
F-level harmProlonged LTCH stay or hospital 
150  52.7%  44.7%  60.5% 
admission 
G-level harmPermanent patient harm  150  6.0%  3.2%  10.8% 
H-level harmLife-sustaining intervention required  150  21.3%  15.5%  28.6% 
I-level harmContributing to or resulting in death  150  20.0%  14.5%  26.9% 
Preventable events  150  62.0%  54.0%  69.4% 
Clinical Category and Event Types for Adverse Events 
Adverse event related to infections  150  45.3%  37.8%  53.1% 
      LTCH-acquired respiratory infection  150  23.3%  17.6%  30.2% 
      Sepsis not associated with another event  150  6.7%  3.6%  11.9% 
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  33 
OEI-06-14-00530   
      Vascular-catheter associated infection  150  4.7%  2.3%  9.2% 
      Clostridium difficile infection  150  2.7%  1.0%  6.6% 
      Surgical site infection  150  2.7%  1.0%  6.6% 
      Urinary tract infection associated with  
150  2.0%  0.7%  5.8% 
      urinary catheter 
      Other infection-related event  150  3.3%  1.4%  7.6% 
Adverse events related to medication  150  31.3%  24.5%  39.1% 
      Bleeding associated with anticoagulant  150  8.7%  5.3%  13.9% 
      Hypoglycemic event  150  8.7%  5.2%  14.2% 
      Delirium and other changes in mental status  150  6.0%  3.0%  11.6% 
      Fluid, electrolyte, and metabolic disorders  150  2.7%  1.0%  6.7% 
      Acute kidney injury or insufficiency  150  2.0%  0.7%  5.9% 
      Other medication-related adverse event  150  3.3%  1.4%  7.6% 
Adverse events related to patient care  150  23.3%  17.5%  30.4% 
      Respiratory issues other than infections  150  4.7%  2.3%  9.3% 
      Venous thromboembolism, deep vein  
      thrombosis, or   150  4.7%  2.3%  9.3% 
      pulmonary embolism 
      Pressure ulcer  150  3.3%  1.4%  7.6% 
      Bleeding not associated with anticoagulant   150  2.7%  1.0%  6.6% 
      Fluid, electrolyte, and metabolic disorder  150  2.0%  0.7%  5.8% 
      Other patient care-related adverse event  150  6.0%  3.2%  10.8% 
Preventability for Temporary Harm Events 
Preventable event  306  49.7%  44.0%  55.4% 
Clinical Category and Event Types for Temporary Harm Events 
Temporary harm events related to medication  306  49.0%  43.6%  54.5% 
      Hypoglycemic event  306  17.3%  13.4%  22.1% 
      Delirium and other changes in mental status  306  10.1%  7.4%  13.8% 
      Bleeding associated with anticoagulants  306  5.2%  3.2%  8.5% 
      Constipation, obstipation, or ileus  306  5.2%  3.3%  8.3% 
      Acute kidney injury or insufficiency  306  2.9%  1.6%  5.5% 
      Allergic reaction  306  2.9%  1.6%  5.4% 
      Other medication-related temporary harm  
306  5.2%  3.3%  8.2% 
      event 
Temporary harm events related to infection  306  26.4%  21.9%  31.6% 
      Soft tissue or other nonsurgical infection  306  9.2%  6.5%  12.7% 
      Thrush   306  4.2%  2.5%  7.0% 
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  34 
OEI-06-14-00530   
      Urinary tract infection associated with  
306  3.6%  2.0%  6.3% 
      urinary catheter 
      Clostridium difficile infection  306  2.9%  1.6%  5.4% 
      LTCH-acquired respiratory infection  306  2.9%  1.6%  5.4% 
      Other infection-related temporary harm  
306  3.6%  2.1%  6.2% 
      event 
Temporary harm event related to patient care  306  24.5%  20.1%  29.5% 
      Pressure ulcer  306  6.5%  4.2%  10.1% 
      Bleeding not associated with anticoagulant  306  3.3%  1.8%  5.9% 
      Venous thromboembolism, deep vein  
306  3.3%  1.8%  5.9% 
      thrombosis, or pulmonary embolism 
      Skin tear, abrasion, or breakdown  306  2.9%  1.6%  5.4% 
      Fall with injury  306  2.3%  1.1%  4.6% 
      Other patient-care-related temporary harm  
306  6.2%  4.0%  9.5% 
      event 
Preventability Classification for All Adverse Events and Temporary Harm Events 
Preventable adverse and temporary harm event  456  53.7%  49.0%  58.3% 
        Clearly preventable  456  7.2%  5.2%  10.0% 
        Likely preventable  456  46.5%  42.0%  51.1% 
Not preventable adverse and temporary harm event  456  45.2%  40.6%  49.8% 
        Likely not preventable  456  42.1%  37.6%  46.7% 
        Clearly not preventable  456  3.1%  1.8%  5.2% 
Unable to determine preventability of adverse and 
456  1.1%  0.5%  2.6% 
temporary harm event 
Preventable adverse event  456  20.4%  16.9%  24.4% 
        Clearly preventable adverse event  456  3.3%  2.0%  5.5% 
        Likely preventable adverse event  456  17.1%  13.8%  21.0% 
Not preventable adverse event  456  11.8%  9.2%  15.2% 
        Likely not preventable adverse event  456  11.6%  9.0%  14.9% 
        Clearly not preventable adverse event  456  0.2%  0.0%  1.5% 
Unable to determine preventability of adverse event  456  0.7%  0.2%  2.0% 
Preventable temporary harm event  456  33.3%  28.9%  38.1% 
        Clearly preventable temporary harm event  456  3.9%  2.5%  6.2% 
        Likely preventable temporary harm event  456  29.4%  25.3%  33.8% 
Not preventable temporary harm event  456  33.3%  29.2%  37.7% 
        Likely not preventable temporary harm event  456  30.5%  26.4%  34.9% 
        Clearly not preventable temporary harm event  456  2.9%  1.6%  4.9% 
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  35 
OEI-06-14-00530   
Unable to determine preventability of temporary 
456  0.4%  0.1%  1.7% 
harm event 
Rationales for All Events Determined To Be Preventable  
Substandard treatment or preventive care  245  57.6%  51.3%  63.6% 
Error related to medical judgment, skill, or 
245  33.9%  27.9%  40.4% 
management 
Patient progress not adequately monitored  245  25.3%  20.1%  31.4% 
Patient care plan was inadequate  245  23.3%  18.3%  29.1% 
Necessary treatment was not provided  245  18.4%  14.1%  23.5% 
Equipment failure or other breakdown  245  2.9%  1.3%  6.3% 
Poor communication among caregivers  245  2.4%  1.1%  5.2% 
Lack of access to physician or specialist  245  2.0%  0.9%  4.7% 
Admission assessment was inadequate for patient  245  1.6%  0.6%  4.2% 
Other  245  11.8%  8.4%  16.5% 
Rationales for All Events Determined To Be Not Preventable 
Patient was highly susceptible to event because of 
206  80.6%  75.0%  85.2% 
health status 
Patients diagnosis was unusual or complex, making 
206  35.9%  29.1%  43.3% 
care difficult 
Event occurred despite proper assessment and 
206  23.8%  18.0%  30.7% 
procedures 
Care provider could not have anticipated the event 
206  12.1%  8.4%  17.2% 
with information available at the time 
Harm was anticipated but was considered acceptable 
206  12.1%  8.1%  17.7% 
given alternatives 
Other  206  4.4%  2.2%  8.5% 
Source: Office of Inspector General analysis of LTCH stays for 587 Medicare beneficiaries in March 2014. 
   
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  36 
OEI-06-14-00530   
APPENDIX E: Rates of Adverse Events and 
Temporary Harm Events by Patient Days and 
LTCH Admissions  
Healthcare facilities commonly measure adverse events by incidence 
density, which takes into account the period during which patients are 
observed.  For example, incidence density is often used in measuring 
healthcare-acquired infections because risk can increase with the length of 
exposure to the health care environment.46  IHI cites advantages to using 
incidence density metrics over standard incidence rates that measure the 
number of events per patient.47  IHI reports that measuring total events by 
patient days or hospital admissions enables hospitals to count multiple 
events experienced by the same patient.  
The sample of 587 Medicare beneficiaries that entered an LTCH in 
March 2014 included 588 total hospital stays (admissions) and a total of 
12,000 days in the hospital (patient days). We calculated patient days by 
subtracting the admission date for each LTCH stay from its discharge date.  
To be consistent with the overall incidence of harm events, we limited the 
length of stay in this metric to a maximum of 25 days.  Exhibit E-1 provides 
ratios for adverse events and temporary harm events in the sample per 
1,000 patient days and per 100 admissions.  Exhibit E-2 provides the rates of 
harm events per 1,000 patient days for SNFs, rehab hospitals, and acute-
care hospitals, in addition to LTCHs. 
Exhibit E-1: Rates of Adverse Events and Temporary Harm Events in 
the Sample by Patient Days and Hospital Admissions 
Per 100 
Per 1,000 Patient 
Category 
Admissions 
Days* 
Adverse Events  13  26  
Temporary harm events  26  52 
Adverse events and temporary 
38  78 
harm events combined 
Source: Office of Inspector General analysis of LTCH stays for 587 Medicare beneficiaries in March 2014.  
*The length of LTCH stay used in the incidence density analysis is capped at 25 days because the 
physician reviews were limited to the first 25 days of each stay. 
 
 
 
 
46 K.M. Arias, Outbreak Investigation, Prevention, and Control in Health Care Settings: Critical 
Issues in Patient Safety (Second Edition), Jones and Bartlett Publishers, 2009, pp. 330-331. 
47 Griffin, Op. cit., p. 13.  
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  37 
OEI-06-14-00530   
 
Exhibit E-2: Rates of Adverse Events and Temporary Harm Events per 1,000 Patient Days across 
Settings 
95-Percent Confidence 
Interval 
Sample  Lower 
Upper Bound 
Estimate Description  Size (n)   Percentage  Bound 
Rate of harm event per 1,000 patient days in SNFs  653  24.3%  20.4%  28.1% 
Rate of harm event per 1,000 patient days in rehab 
417  29.3%  24.3%  34.3% 
hospitals 
Rate of harm event per 1,000 patient days in LTCHs  587  38.0%  33.9%  42.1% 
Rate of harm event per 1,000 patient days in acute-
780  69.4%  61.2%  77.5% 
care hospitals 
Source: Office of Inspector General analysis of LTCH stays for 587 Medicare beneficiaries in March 2014, rehab hospital stays for 417 Medicare 
beneficiaries in March 2012, SNF stays for 653 Medicare beneficiaries in August 2011, and hospital stays for 780 Medicare beneficiaries in October 
2008. 
   
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  38 
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APPENDIX F: Adverse Events and Temporary 
Harm Events Identified in the Sample 
Exhibits F-1 and F-2 contain information about adverse events and 
temporary harm events identified in the sample, including the description, 
harm level, and preventability.  Exhibit F-1 contains information about 
adverse events (150 adverse events).  Exhibit F-2 contains information about 
temporary harm events (306 events).  Harm levels are labeled as F through I, 
in accordance with the NCC MERP Index.  Preventability determinations are 
labeled as CP (clearly preventable), LP (likely preventable), LNP (likely not 
preventable), CNP (clearly not preventable), and UTD (unable to determine.) 
 
Exhibit F-1: Adverse Events by Clinical Category, Harm Level, and Preventability (n=150) 
Adverse Event  Harm Level  Preventability 
Adverse Events Related to Infections (68) 
LTCH-acquired respiratory infections (35) 
1.  Pneumonia contributing to patient death  I  LP 
2.  Pneumonia contributing to patient death  I  LP 
3.  Respiratory syncytial virus (RSV) pneumonia associated with 
aspiration resulting in transfer to an acute-care hospital and  I  LP 
contributing to death 
4.  Pneumonia contributing to patient death  I  LNP 
5.  Cascade with pneumonia leading to hypotension and hypoxia and 
I  UTD 
ultimately death 
6.  Pneumonia with septic shock (Klebsiella pneumoniae) resulting in 
I  UTD 
an acute-care hospital admission and contributing to death 
7.  Pneumonia and respiratory failure with delayed recognition and 
H  LP 
treatment resulting in transfer to an acute-care hospital 
8.  Pneumonia  H  LNP 
9.  Aspiration and respiratory failure  H  LNP 
10. Pneumonia with respiratory failure requiring intubation and 
H  LNP 
sending to an acute-care hospital 
11.  Cascade with aspiration pneumonia leading to sepsis leading to 
G  LNP 
acute kidney injury 
12. Cascade in which tracheal laceration led to decreasing oxygen 
saturation resulting in sending to an acute-care hospital for  F  CP 
treatment 
13. Aspiration pneumonitis/pneumonia with inadequate preventive 
F  LP 
care 
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  39 
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14. Cascade with opioids (respiratory depressant) complicated by 
F  LP 
morbid obesity and sleep apnea leading to aspiration pneumonia 
15. Cascade with respiratory infection while on ventilator leading to 
F  LP 
acute kidney injury and hyperkalemia (K+ 6.2) 
16. Pneumonia while on ventilator  F  LP 
17. Pneumonia with delayed recognition and treatment  F  LP 
18. Aspiration pneumonia  F  LNP 
19. Aspiration pneumonia  F  LNP 
20. Cascade with pneumonia leading to septic shock  F  LNP 
21. Cascade with pneumonia leading to septic shock while on a 
F  LNP 
ventilator 
22. Pneumonia  F  LNP 
23. Pneumonia  F  LNP 
24. Pneumonia  F  LNP 
25. Pneumonia while on a ventilator  F  LNP 
26. Pneumonia resulting in an acute-care hospital admission  F  LNP 
27. Pneumonia while on a ventilator  F  LNP 
28. Pneumonia while on ventilator  F  LNP 
29. Pneumonia while on ventilator  F  LNP 
30. Pneumonia while on ventilator  F  LNP 
31. Pneumonia while on ventilator  F  LNP 
32. Pneumonia with dyspnea treated with BiPAP  F  LNP 
33. Pneumonia/respiratory failure, suspected aspiration  F  LNP 
34. Recurrent pneumonia  F  LNP 
35. Tracheobronchitis while on ventilator  F  LNP 
Sepsis not associated with other event types (10) 
1.  Cascade with candidemia with widespread infection treated with 
ineffective medication for several days, leading to increased  I  LP 
bruising, respiratory failure, and contributing to death 
2.  Cascade with peritonitis in the wake of PEG placement followed 
by sepsis, hypotension, acute kidney injury, shock liver, requiring  I  LP 
treatment at an acute-care hospital and contributing to death 
3.  Cascade with stage 4 infected pressure ulcer leading to septic 
I  LP 
shock and contributing to patient death 
4.  Sepsis due to intra-abdominal sepsis associated with aspiration  I  LP 
5.  Sepsis with delayed recognition contributing to patient death  I  LP 
6.  Septic shock with worsening pulmonary status resulting in patient 
I  UTD 
death 
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  40 
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7.  Cascade with septic shock related to urinary catheter with delayed 
recognition leading to respiratory failure and profound electrolyte  H  LP 
imbalance resulting in an acute-care hospital admission 
8.  Cascade with non-antiseptic debridement of sacral decubitus 
leading to sacral infection followed by blood stream infection  F  LP 
requiring treatment at an acute-care hospital 
9.  Sepsis with inadequate monitoring and delayed recognition  F  LP 
10. Septicemia (MRSA and Klebsiella) with delayed recognition  F  LP 
Vascular-catheter associated infections (7) 
1.  Central line related sepsis/fungemia contributing to death  I  LP 
2.  Fungal central line-associated bloodstream infection leading to 
I  LP 
acute renal failure and contributing to death 
3.  Probable PICC line infection (persistent Stenotrophomonas 
bacteremia) leading to septic shock and death with concurrent 
I  LP 
urinary tract infection (Acinetobacter multi-drug resistance [MDR]) 
associated with a urinary catheter 
4.  PICC line associated with Escherichia coli  sepsis contributing to 
I  LNP 
patient death 
5.  PICC line associated with Enterococcus and transfer to an 
F  LP 
acute-care hospital 
6.  Prolonged PICC line placement associated with sepsis  F  LP 
7.  Presumed dialysis catheter source of sepsis  F  LNP 
Clostridium difficile infections (4) 
1.  Cascade with severe Clostridium difficile infection with delayed 
diagnosis leading to sepsis resulting in toxic metabolic  F  CP 
encephalopathy, treatment at an acute-care hospital 
2.  Clostridium difficile infection  F  LP 
3.  Clostridium difficile infection  F  LP 
4.  Clostridium difficile  infection following antibiotics  F  LP 
Surgical site infections (4) 
1.  Abdominal wall abscess associated with dislodged feeding tube 
F  LP 
which required sending to an acute-care hospital for treatment 
2.  PEG site infection resulting in PEG change in an acute-care 
F  LP 
hospital 
3.  Soft tissue infection at PICC entrance site extending into axilla  F  LP 
4.  Abscess at tracheostomy site  F  LNP 
Urinary tract infections associated with urinary catheters (3) 
1.  Cascade initiated by clinical urinary tract infection associated with 
urinary catheter leading to sepsis resulting in hypotension and  F  LP 
admission to an acute-care hospital 
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  41 
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2.  Cascade with clinical urinary tract infection associated with urinary 
F  LP 
catheter leading to septic shock 
3.  CDC-defined catheter-associated urinary tract infection (CAUTI)  F  LP 
Soft tissue or other nonsurgical infections (2) 
1.  Infected, necrotic chest wall wound  F  LP 
2.  Ischial osteomyelitis  F  LNP 
Ventilator-associated events (2) 
1.  CDC-defined infection-related ventilator-associated complication    F  LNP 
2.  CDC-defined infection-related ventilator-associated complication    F  LNP 
Other infection-related adverse events (1)     
1.  Meningoencephalitis with delayed recognition contributing to 
I  LP 
patient death 
Adverse Events Related to Medication (47) 
Bleeding associated with anticoagulants (13) 
1.  Gastrointestinal bleeding while on anticoagulant (intravenous 
I  CP 
heparin) contributing to death 
2.  Epistaxis (significant bleeding from the nose) while on 
I  LNP 
anticoagulants (heparin and aspirin) contributing to patient death 
3.  Cascade with gluteal hematoma while on anticoagulant (warfarin) 
leading to anemia and acute kidney injury and sent to an  H  LP 
acute-care hospital for treatment 
4.  Cascade with hematuria (excessive bleeding) while on 
anticoagulant (warfarin) following self-removed urinary catheter 
H  LP 
injury leading to hypotension and eventually requiring an 
acute-care hospital admission 
5.  Cascade in which retroperitoneal bleeding due to anticoagulants 
(warfarin and enoxaparin) led to hypotension and blood loss  H  LNP 
anemia requiring transfusions 
6.  Cascade with significant epistaxis due to anticoagulation (warfarin) 
and tube feedings leading to aspiration pneumonia and transfer  H  LNP 
to an acute-care hospital 
7.  Large subdural hematoma while on heparin resulting in an 
G  LNP 
acute-care hospital admission and surgical treatment 
8.  Iatrogenic traumatic oropharyngeal bleeding related to suctioning 
F  LP 
in patient with tracheostomy 
9.  Penile bleeding while over-anti-coagulated (INR 4.5) leading to 
F  LP 
catheter change 
10. Hematuria (blood in urine) following urinary catheterization while 
F  LNP 
on anticoagulation with warfarin 
11.  Lower gastrointestinal bleeding while on warfarin  F  LNP 
12. Traumatic urinary catheter insertion in patient on an anticoagulant 
F  LNP 
medication (enoxaparin) led to hemorrhage requiring transfusion 
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  42 
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13. Heparin induced thrombocytopenia complicated by abdominal 
F  CNP 
wall hematoma 
Hypoglycemic events (13) 
1.  Hypoglycemia with lethargy (blood glucose of 29, 46)  H  CP 
2.  Cascade with hypoglycemia with unresponsiveness and triggering 
H  LP 
a seizure (blood glucose of 22, 23, 25) 
3.  Hypoglycemia requiring substantial administration of glucose 
H  LP 
(D50 x 2) followed by D10 infusion (blood glucose of 36, <20) 
4.  Hypoglycemia with cool and clammy skin (blood glucose of       
H  LP 
30, 33) 
5.  Hypoglycemia with decreased responsiveness (blood glucose of 
H  LP 
47, 37) 
6.  Hypoglycemia with lethargy (blood glucose of 30)  H  LP 
7.  Hypoglycemia with lethargy on two separate occasions (blood 
H  LP 
glucose of 36, 22) 
8.  Hypoglycemia with lethargy, clammy, and cool to the touch 
H  LP 
(blood glucose of 22, 38, 29) 
9.  Hypoglycemia with somnolence (blood glucose of 27, 37)  H  LP 
10. Hypoglycemia with unresponsiveness (blood glucose of 32)  H  LP 
11.  Severe hypoglycemia with hypothermia and confusion (blood 
H  LP 
glucose of 39) 
12. Hypoglycemia episodes over several days (blood glucose of      
F  LNP 
25, 40) 
13. Hypoglycemia in a brittle diabetic (blood glucose ranging from   
F  LNP 
22 - 45) 
Delirium and other changes in mental status (9) 
1.  Cascade with oversedation while on multiple opioid medications 
leading to a fall resulting in a subdural hematoma, requiring  I  CP 
acute-care hospital care, and ultimately death 
2.  Altered mental status and respiratory failure secondary to opioids 
H  CP 
(hydromorphone and fentanyl) 
3.  Lethargy with hypotension while on opioid pain medication 
H  CP 
(morphine immediate release) 
4.  Respiratory depression while on opioid medication in morbidly 
H  LNP 
obese patient 
5.  Cascade with confusion while on multiple psychotropic 
F  LP 
medications leading to fall with injury to shoulder 
6.  Delirium while on antipsychotic medication (risperidone) and 
F  LP 
opioid (oxycodone) 
7.  Failure to identify and treat delirium due to multiple medication 
(antihistamine [diphenhydramine] and anti-anxiety  F  LP 
[benzodiazepine-alprazolam]) over several days 
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  43 
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8.  Oversedation with hypotension due to multiple anti-anxiety and 
F  LP 
opioid medications 
9.  Toxic metabolic encephalopathy due to opioid pain medication 
(oxycodone) with underlying renal and liver failure resulting in  F  LP 
transfer to an acute-care hospital 
Fluid, electrolyte, and metabolic disorders related to medication (4) 
1.  Severe hypothyroidism with inadequate treatment and 
I  CP 
contributing to death 
2.  Volume overload with subsequent pulmonary edema in a patient 
unable to tolerate volume due to myxedema contributing to  I  CP 
patient death 
3.  Cascade with unrecognized and untreated hypothyroidism 
despite admission with thyroid-stimulating hormone of 28.2 
H  CP 
(normal is 0.4-4) leading to myxedema resulting in cardiac arrest-
pulseless ventricular tachycardia 
4.  Hyponatremia secondary to medication (spironolactone); 
F  LP 
transferred to an acute-care hospital 
Acute kidney injury or insufficiency (3) 
1.  Acute kidney injury due to vancomycin  G  LP 
2.  Acute kidney injury while on a diuretic (furosemide)  G  LNP 
3.  Acute kidney injury while on colistin resulting in altered mental 
F  LNP 
status and requiring temporary dialysis 
Other medication-related adverse events (5) 
1.  Intracranial hemorrhage on anticoagulant medication (aspirin, 
I  LNP 
clopidogrel, warfarin, and heparin) contributing to death 
2.  Omission of appropriate care for life-threatening digoxin level  H  CP 
3.  Hypotension with bradycardia and unresponsiveness due to 
H  LP 
antihypertensive medication (lisinopril and clonidine) 
4.  Nausea and vomiting while on immunosuppressant 
F  LNP 
(mycophenolate mofetil) to prevent transplant rejection 
5.  Unrecognized Stevens-Johnson Syndrome secondary to 
F  CP 
allopurinol 
Adverse Events Related to Patient Care (35) 
Respiratory issues (other than infections) (7) 
1.  Cascade with aspiration with large amount of gastric contents in 
tracheal tube followed by cardiac arrest and failed resuscitation  I  LP 
attempt contributing to death 
2.  Respiratory distress associated with inadequate monitoring 
I  LP 
leading to intubation and death 
3.  Aspiration with rhonchi, tachypnea and tachycardia leading to 
I  LNP 
patient death in comfort care patient 
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  44 
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4.  Aspiration leading to transient hypoxemia with reduced gas 
exchange and preexisting malignant pleural effusions requiring  H  LP 
treatment at an acute-care hospital 
5.  Cascade with significant pleural effusion with failure to recognize 
and treat leading to respiratory acidosis and cardiac arrest during  H  LP 
hemodialysis 
6.  Respiratory failure with delayed response resulting in an 
H  LP 
acute-care hospital admission 
7.  Mucus plug  F  LNP 
Venous thromboembolisms, deep vein thrombosis, or pulmonary embolisms (7) 
1.  Acute pulmonary embolus with inadequate prevention 
I  CP 
contributing to death 
2.  Deep vein thrombosis of bilateral lower extremities with 
F  LP 
inadequate preventive care 
3.  Pulmonary embolism resulting in transfer to intensive care unit 
associated with subtherapeutic INR after premature stopping of  F  LP 
heparin 
4.  Right upper lobe pulmonary embolus  F  LP 
5.  Deep vein thrombosisoccluded popliteal and superficial femoral 
F  LNP 
veins 
6.  Deep vein thrombosis of bilateral lower extremities  F  LNP 
7.  Deep vein thrombosis upper extremity associated with PICC line  F  LNP 
Fluid, electrolyte, and metabolic disorders (not medication related) (3) 
1.  Hyperkalemia of 6.7 resulting in asystole/death  I  CP 
2.  Cascade with hyperkalemia (potassium of 6.2) leading to 
dysrhythmia due to failure hemodialysis and eventually resulting  F  CP 
in related acute-care hospital admission 
3.  Hyperkalemia ultimately treated successfully with fludrocortisone 
F  LP 
after delayed recognition 
Pressure ulcers (5) 
1.  New sacrococcygeal pressure ulcer that progressed to stage 4 
G  LP 
during LTCH stay 
2.  Pressure ulcer of heel that progressed from stage 2 to 
G  LP 
unstageable during the LTCH stay 
3.  Progression from stage 2 to stage 4 sacral pressure ulcer  G  LP 
4.  Heel pressure ulcer  F  LP 
5.  Stage 2 pressure ulcer of heel worsened during stay  F  LNP 
Bleeding not associated with anticoagulants (4) 
1.  Cascade with gastrointestinal bleeding leading to hypotension, 
transfusion, and norepinephrine infusion with delay in sending to  H  LP 
an acute care hospital 
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  45 
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2.  Acute gastrointestinal bleeding with delayed transfer to an 
F  LP 
acute-care hospital for treatment 
3.  Bleeding at PEG insertion site  F  LNP 
4.  Cascade with Foley catheter obstruction leading to urethral 
dissection and bleeding resulting in blood loss anemia requiring  F  LNP 
transfusion 
Acute kidney injury or insufficiency (2) 
1.  Cascade initiated by failed catheter replacement resulting in 
urethral obstruction leading to renal failure and ultimately death  G  LP 
(patient family refused dialysis) 
2.  Acute kidney injury superimposed on chronic renal insufficiency 
G  LNP 
(family refused dialysis) 
Delirium and other mental status changes not associated with medication (2) 
1.  Inadequately treated and monitored patient with oliguric renal 
failure who self-removed four hemodialysis catheters leading to  I  LP 
death 
2.  Cascade beginning with delirium leading to the dislodgement of 
the tracheal tube by the patient resulting in desaturation,  H  LP 
hypoxemia, replacement of the tube, and aspiration pneumonia 
Fall with injury (2) 
1.  Fall with recurrent right hip fracture associated with inadequate 
F  LP 
monitoring 
2.  Fall with hip pain  F  LNP 
Volume overload (2) 
1.  Acute respiratory failure due to congestive heart failure 
exacerbated by intravenous fluids (fluid overload) contributing to  I  LNP 
death 
2.  Acute pulmonary edema due to volume overload from blood 
H  LP 
transfusion 
Urinary retention (1) 
1.  Cascade with delayed diagnosis of urinary retention leading to 
F  LP 
nausea/vomiting and aspiration pneumonia 
Source: OIG analysis of LTCH stays for 587 Medicare beneficiaries entering an LTCH in March 2014. 
 
 
 
 
 
 
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  46 
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Exhibit F-2: Temporary Harm Events by Clinical Category and Preventability (n=306) 
Temporary Harm Event  Preventability 
Temporary Harm Events Related to Medication (150) 
Hypoglycemic events (53) 
1.  Hypoglycemia (blood glucose of 38)  CP 
2.  Hypoglycemia (blood glucose of 40, 46, 47)  CP 
3.  Hypoglycemia (blood glucose of 44, 29)  CP 
4.  Hypoglycemia (blood glucose of 44, 45)  CP 
5.  Hypoglycemia (blood glucose of 45)  CP 
6.  Hypoglycemia (blood glucose of 45, 49)  CP 
7.  Hypoglycemia (blood glucose of 46)  CP 
8.  Hypoglycemia (blood glucose of 48, 40)  CP 
9.  Hypoglycemia (blood glucose 41, 40, documented as <40, 40, 46, 41, 30, 39)  LP 
10. Hypoglycemia (blood glucose documented as <49)  LP 
11.  Hypoglycemia (blood glucose of 21, 45, 44, 45)  LP 
12. Hypoglycemia (blood glucose of 32)  LP 
13. Hypoglycemia (blood glucose of 33, repeat 38)  LP 
14. Hypoglycemia (blood glucose of 34, 38, 41)  LP 
15. Hypoglycemia (blood glucose of 36)  LP 
16. Hypoglycemia (blood glucose of 39)  LP 
17. Hypoglycemia (blood glucose of 40)  LP 
18. Hypoglycemia (blood glucose of 41)  LP 
19. Hypoglycemia (blood glucose of 41)  LP 
20. Hypoglycemia (blood glucose of 42)  LP 
21. Hypoglycemia (blood glucose of 42)  LP 
22. Hypoglycemia (blood glucose of 44)  LP 
23. Hypoglycemia (blood glucose of 44)  LP 
24. Hypoglycemia (blood glucose of 44)  LP 
25. Hypoglycemia (blood glucose of 44)  LP 
26. Hypoglycemia (blood glucose of 46)  LP 
27. Hypoglycemia (blood glucose of 47, 48)  LP 
28. Hypoglycemia (blood glucose of 49)  LP 
29. Hypoglycemia (blood glucose of 49, 37)  LP 
30. Hypoglycemia with lethargy (blood glucose of 38)  LP 
31. Hypoglycemia with lethargy (blood glucose of 39)  LP 
32. Hypoglycemia with lethargy (blood glucose of 48)  LP 
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  47 
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33. Hypoglycemia with near syncope (blood glucose of 51)  LP 
34. Hypoglycemia with symptoms (blood glucose of 30)  LP 
35. Hypoglycemia with weakness (blood glucose of 30)  LP 
36. Hypoglycemic episode (blood glucose of 46)  LP 
37. Hypoglycemia (blood glucose <30)  LNP 
38. Hypoglycemia (blood glucose of 31)  LNP 
39. Hypoglycemia (blood glucose of 33)  LNP 
40. Hypoglycemia (blood glucose of 36, 33)  LNP 
41. Hypoglycemia (blood glucose of 39)  LNP 
42. Hypoglycemia (blood glucose of 39, 49)  LNP 
43. Hypoglycemia (blood glucose of 40)  LNP 
44. Hypoglycemia (blood glucose of 42)  LNP 
45. Hypoglycemia (blood glucose of 45)  LNP 
46. Hypoglycemia (blood glucose of 46)  LNP 
47. Hypoglycemia (blood glucose of 46)  LNP 
48. Hypoglycemia (blood glucose of 46, 47)  LNP 
49. Hypoglycemia (blood glucose of 47)  LNP 
50. Hypoglycemia (blood glucose of 48)  LNP 
51. Hypoglycemia (blood glucose of 48, 39)  LNP 
52. Hypoglycemia (blood glucose of 48; repeat 45)  LNP 
53. Hypoglycemia with symptoms (shakiness, blood glucose of 60)  LNP 
Delirium and other changes in mental status (31) 
1.  Delirium while on multiple sedating medications (antipsychotic [ziprasidone] 
CP 
and anti-anxiety [lorazepam]) 
2.  Delirium while on pain and anti-anxiety medication (opioid and 
CP 
benzodiazepine [diazepam]) 
3.  Mental status changes due to opioid analgesics (intravenous hydromorphone)  CP 
3.  Somnolence due to anti-anxiety medications (lorazepam and clonazepam), 
CP 
nonstandard prescription of benzodiazepines 
5.  Altered mental status while on anti-anxiety benzodiazepine (clonazepam) 
LP 
medication 
6.  Cascade in which somnolence in a patient with history of respiratory failure 
and multiple sedating (psychotropic and pain) medications with frequent falls  LP 
resulting in back pain 
7.  Cascade with oversedation and hypotension while on multiple opioids 
(oxycodone/acetaminophen and fentanyl patch) resulting in multiple falls with  LP 
pain 
8.  Confusion while on antiemetic (treatment of vomiting) medication 
LP 
(scopolamine patch) 
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  48 
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9.  Delirium due to multiple medications (opioids and antidepressants)  LP 
10. Delirium due to multiple sedating medications including opioid pain 
medication (intravenous hydromorphone), multiple psychotropic medications  LP 
and gabapentin 
11.  Delirium while on opioid medication (fentanyl)  LP 
12. Hallucinations and agitation while on opioid analgesic medication (fentanyl 
LP 
and meperidine) 
13. Insomnia and anxiety related to polypharmacy  LP 
14. Lethargy due to anti-anxiety medication (chlordiazepoxide)  LP 
15. Lethargy while on antipsychotic (haloperidol) medication  LP 
16. Lethargy while on multiple psychotropic medications (quetiapine, lorazepam, 
LP 
alprazolam) and opioid (fentanyl) 
17. Lethargy while on opioid given for pain (fentanyl)  LP 
18. Oversedation due to opioid analgesic (hydrocodone)  LP 
19. Oversedation while on anti-anxiety benzodiazepine (alprazolam) medication  LP 
20. Somnolence while on anti-anxiety medication (alprazolam)  LP 
21. Somnolence while on opioids (intravenous meperidine, hydrocodone, 
LP 
codeine) and antihistamine (diphenhydramine) medication 
22. Agitation and oversedation while on antipsychotic (quetiapine) with 
LNP 
preexisting Alzheimers disease 
23. Altered mental status while on anti-anxiety benzodiazepine medication 
LNP 
(lorazepam) 
24. Cascade with schizoaffective disorder treated with quetiapine leading to 
LNP 
delirium leading to a fall with contusion to head 
25. Confusion and agitation while on anti-anxiety benzodiazepine (lorazepam) 
LNP 
medication 
26. Delirium while on antidepressants (mirtazapine and sertraline)  LNP 
27. Delirium while on opioid (morphine) and muscle relaxant (cyclobenzaprine)  LNP 
28. Delirium while on opioid medication and gabapentin superimposed on pre-
LNP 
existing metabolic encephalopathy 
29. Lethargy while on an antidepressant medication (mirtazapine)  LNP 
30. Oversedation while on opioid (hydrocodone)  LNP 
31. Somnolence and sedation while on opioid (hydromorphone)  LNP 
Constipation, obstipation, or ileus (16) 
1.  Constipation with abdominal pain due to opioid pain medication  CP 
2.  Constipation with abdominal pain due to opioids and immobility  CP 
3.  Abdominal distension and discomfort while taking opioid analgesic 
LP 
(methadone) 
4.  Constipation with abdominal distension while on opioid medication (morphine 
LP 
and hydrocodone) 
Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries  49 
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5.  Constipation with abdominal distension and pain following opioid medication 
LP 
(hydrocodone and intravenous morphine)  
6.  Constipation with abdominal distension while on opioid pain medication 
LP 
(hydrocodone) 
7.  Constipation with abdominal pain while on iron sucrose  LP 
8.  Constipation with bloating and x-ray revealing abundant rectal stool while on 
LP 
opioid pain medication (oxycodone) and iron (ferrous sulfate) 
9.  Constipation with distended abdomen while on prn (as needed) 
LP 
hydromorphone associated with inadequate care plan 
10. Constipation with fecal impaction and delayed diagnosis while on opioid pain 
LP 
medication (tramadol) 
11.  Constipation/ileus with nausea while on opioids  LP 
12. Fecal impaction with abdominal pain while on iron (ferrous sulfate)  LP 
13. Constipation substantiated by x-ray with abdominal pain while on opioid 
LP 
medication (hydrocodone) 
14. Abdominal distension with kidneys, ureter, and bladder consistent with ileus 
LNP 
while on opioid pain medication (morphine) 
15. Constipation with abdominal discomfort after recently receiving opioid 
LNP 
(hydrocodone) 
16. Constipation with abdominal distension while on opioid pain medication 
LNP 
(tramadol) 
Bleeding associated with anticoagulants (16) 
1.  Bleeding from penis with catheter change due to anticoagulants (enoxaparin 
LP 
and warfarin) 
2.  Gastrointestinal bleeding while on anticoagulant (heparin)  LP 
3.  Gastrointestinal bleeding while on anticoagulant (warfarin) with prolonged INR 
LP 
(excessive anticoagulation) 
4.  Bleeding from tracheostomy site while on an anticoagulation medication 
LNP 
(heparin) 
5.  Epistaxis (nasal bleeding) associated with anticoagulation (warfarin) and 
LNP 
trauma from catheter use 
6.  Epistaxis while on enoxaparin with blood loss anemia requiring transfusions  LNP 
7.  Epistaxis while on heparin  LNP 
8.  Frank blood from the penile meatus in patient with Foley catheter while on 
LNP 
rivaroxaban 
9.  Gastrointestinal bleeding (coffee-ground emesis) while anticoagulated  LNP 
10. Gastrointestinal bleeding while on anticoagulant (enoxaparin)  LNP 
11.  Gastrointestinal bleeding while on anticoagulation (heparin and aspirin) 
LNP 
requiring transfusion 
12. Hemoptysis (cough with associated bleeding) while on anticoagulants 
LNP 
(clopidogrel and fondaparinux) 
13. Lower gastrointestinal bleeding while on anticoagulation medications 
LNP 
(enoxaparin and warfarin) 
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14. Rectal bleeding due to anticoagulants (enoxaparin and warfarin)  LNP 
15. Rectus sheath hematoma while on anticoagulant (warfarin)  LNP 
16. Right nares epistaxis while on warfarin  LNP 
Acute kidney injury or insufficiency (9) 
1.  Acute kidney injury while on antibiotic (vancomycin) and angiotensin-
LP 
convertor enzyme (ACE) inhibitor (lisinopril) 
2.  Acute kidney injury while on diuretics (spironolactone and furosemide)  LP 
3.  Acute kidney injury due to vancomycin  LNP 
4.  Acute kidney injury while on an antibiotic (vancomycin)  LNP 
5.  Acute kidney injury while on antibiotic (vancomycin)  LNP 
6.  Acute kidney injury while on vancomycin  LNP 
7.  Acute kidney injury while taking multiple medications likely to cause it (ACE 
LNP 
inhibitor and diuretics) 
8.  Acute kidney injury with hypotension while on ACE inhibitor (lisinopril)  LNP 
9.  Cascade with acute kidney injury resulting in hyperkalemia while on ACE 
LNP 
inhibitor (lisinopril) and diuretic (furosemide) 
Allergic reactions (9) 
1.  Diffuse pruritus while on colistin  CNP 
2.  Drug fever while on antibiotic (piperacillin/tazobactam)  CNP 
3.  Pruritic back rash treated with an antihistamine (diphenhydramine)  CNP 
4.  Pruritus due to opioids  CNP 
5.  Rash developed while on an antibiotic (piperacillin-tazobactam)  CNP 
6.  Rash while on antibiotics (levofloxacin and vancomycin)  CNP 
7.  Rash while on antibiotics (piperacillin, tazobactam, and clindamycin)  CNP 
8.  Skin rash due to antibiotic meropenem  CNP 
9.  Skin rash on antibiotic ciprofloxacin  CNP 
Diarrhea (5) 
1.  Diarrhea while on laxatives  LP 
2.  Diarrhea while on antibiotic  LNP 
3.  Diarrhea while on antibiotic (clindamycin) and stool softener (docusate)  LNP 
4.  Diarrhea while on laxative  LNP 
5.  Diarrhea with nausea while on linezolid  LNP 
Other medication-related temporary harm events (11) 
1.  Dizziness while on opioid (hydromorphone) medication  LP 
2.  Seizure related to withdrawal of anticonvulsant medication (levetiracetam)   LP 
3.  Idioventricular arrhythmia while on cardizem  LNP 
4.  Metabolic alkalosis due to diuretics (bumetanide)  LNP 
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5.  Profound malaise after initiation of bronchodilator (theophylline)  LNP 
6.  Nausea and vomiting after starting opioid medication (tramadol)  LNP 
7.  Skin lesions with slough consistent with Stevens-Johnson syndrome while on 
LNP 
the antibiotic meropenem 
8.  Trembling with increasing doses of pregabalin  LNP 
9.  Chorea while on anticonvulsant (levetiracetam)  CNP 
10. Worsening tinnitus while on aspirin (acetylsalicylic acid)  CNP 
11.  Significant elevation of liver function tests  UTD 
Temporary Harm Events Related to Infections (81)   
Soft tissue or other nonsurgical infections (28) 
1.  Bacterial conjunctivitis  LP 
2.  Conjunctivitis  LP 
3.  Conjunctivitis  LP 
4.  Conjunctivitis, likely viral  LP 
5.  Fungal infection (axilla)  LP 
6.  Fungal infection/rash (scrotum and penis)  LP 
7.  Impetigo due to staphylococcus  LP 
8.  Local infection at site of PICC insertion  LP 
9.  Skin infection - Sarcoptes scabiei  var. hominis (Scabies mites)  LP 
10. Conjunctivitis  LNP 
11.  Conjunctivitis  LNP 
12. Fungal dermatitis (buttocks) while on steroids and antibiotics  LNP 
13. Fungal dermatitis (groin)  LNP 
14. Fungal dermatitis associated with diarrhea while on antibiotics  LNP 
15. Fungal infection (external genitalia and adjoining perineal skin)  LNP 
16. Fungal infection (foot)  LNP 
17. Fungal infection (gluteus)  LNP 
18. Fungal infection (groin)  LNP 
19. Fungal infection (perineal area)  LNP 
20. Fungal infection (upper extremity)  LNP 
21. Sacral candidiasis in part due to antibiotics and immobility  LNP 
22. Skin abscess back shoulder area  LNP 
23. Tinea cruris (fungal infection of groin area)  LNP 
24. Tinea cruris (perineal)  LNP 
25. Tinea cruris with excoriations (groin, perineal)  LNP 
26. Vaginal candidiasis  LNP 
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27. Vaginal candidiasis while on antibiotics  LNP 
28. Vaginal candidiasis while on antibiotics  LNP 
Thrush (13) 
1.  Oral thrush after antibiotics  LNP 
2.  Oral thrush due to antibiotics  LNP 
3.  Oral thrush due to antibiotics  LNP 
4.  Oral thrush due to steroid inhaler  LNP 
5.  Oral thrush following multiple antibiotics  LNP 
6.  Oral thrush related to chemotherapy and radiation therapy  LNP 
7.  Oral thrush while on antibiotics  LNP 
8.  Oral thrush while on antibiotics  LNP 
9.  Oral thrush while on antibiotics  LNP 
10. Oral thrush while on antibiotics  LNP 
11.  Oral thrush while on antibiotics  LNP 
12. Oral thrush while on antibiotics  LNP 
13. Oral thrush while on antibiotics  LNP 
Urinary tract infections associated with urinary catheters (11) 
1.  CDC-defined catheter-associated urinary tract infection (CAUTI)  LP 
2.  CDC-defined CAUTI  LP 
3.  CDC-defined CAUTI  LP 
4.  CDC-defined CAUTI  LP 
5.  CDC-defined CAUTI  LP 
6.  CDC-defined CAUTI  LP 
7.  CDC-defined CAUTI  LP 
8.  CDC-defined CAUTI  LP 
9.  CDC-defined CAUTI  LP 
10. Clinical urinary tract infection associated with urinary catheter  LP 
11.  Urinary tract infection associated with catheter  LP 
Clostridium difficile infection (9) 
1.  Clostridium difficile infection  LP 
2.  Clostridium difficile infection  LP 
3.  Clostridium difficile infection  LP 
4.  Clostridium difficile infection  LP 
5.  Clostridium difficile infection  LP 
6.  Clostridium difficile infection  LP 
7.  Clostridium difficile infection  LP 
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8.  Clostridium difficile infection  LP 
9.  Clostridium difficile infection  LP 
LTCH-acquired respiratory infections (9) 
1.  Aspiration pneumonia  LNP 
2.  Aspiration pneumonia (MRSA)  LNP 
3.  Bronchitis  LNP 
4.  Pneumonia  LNP 
5.  Pneumonia (suspected aspiration)  LNP 
6.  Pneumonia (suspected aspiration)  LNP 
7.  Pneumonia while on ventilator  LNP 
8.  Pneumonia while on ventilator  LNP 
9.  Pneumonia/bronchitis  LNP 
Surgical site infections (5) 
1.  Cellulitis at PEG site  LP 
2.  Infection at site of ankle surgery  LP 
3.  Late wound infection and subsequent partial dehiscence due to inadequate 
LP 
wound care 
4.  Wound infection of below knee amputation suture line with small dehiscence 
LP 
(rupture) 
5.  Superficial abdominal infection at prior Jackson-Pratt drain site  LNP 
Vascular-catheter associated infections (4) 
1.  Cellulitis/abscess at PICC site  LP 
2.  Central line infection followed by sepsis  LP 
3.  PICC line associated with septicemia (Klebsiella)  LP 
4.  PICC line associated with fungemia  LNP 
Other infection-related temporary harm events (2) 
1.  Cascade with sepsis leading to acute kidney injury leading to mental status 
LP 
changes 
2.  Parotitis due to dehydration  LNP 
Temporary Harm Events Related to Patient Care (75) 
Pressure ulcers (20) 
1.  Stage 2 nasal pressure ulcer associated with face mask  CP 
2.  Deep tissue injuries related to ace wraps  LP 
3.  New stage 2 sacral pressure ulcer  LP 
4.  Progression of stage 2 to stage 3 sacral pressure ulcer  LP 
5.  Sacral pressure ulcer  LP 
6.  Stage 1 coccygeal pressure ulcer  LP 
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7.  Stage 1 facial pressure ulcer associated with BiPAP mask  LP 
8.  Stage 1 pressure ulcer heel  LP 
9.  Stage 1 pressure ulcer on sacrum  LP 
10. Stage 1 sacral pressure ulcer  LP 
11.  Stage 2 pressure ulcer of sacrum  LP 
12. Stage 2 pressure ulcer of sacrum  LP 
13. Suspected deep tissue injury of sacral area  LP 
14. Suspected deep tissue injury of the sacrum  LP 
15. Worsening pressure ulcer of sacrum  LP 
16. New unstageable pressure ulcer (left ischium)  LNP 
17. New unstageable pressure ulcer (right ischium)  LNP 
18. Progression of stage 2 pressure ulcer to unstageable  LNP 
19. Temporal (side of head) pressure ulcer  LNP 
20. Unclassified sacral ulcer  LNP 
Bleeding not directly associated with anticoagulants (10) 
1.  Gross hematuria due to trauma from urinary catheter placement  CP 
2.  Bleeding at insertion site of venous catheter due to cap falling off PICC line 
LP 
while on anticoagulant medication (warfarin) and antibiotic (linezolid) 
3.  Bleeding from tracheostomy with hardware-induced soft tissue injury  LP 
4.  Hematuria (blood in urine) associated with traumatic urinary catheterization  LP 
5.  Hematuria, likely mechanical from the Foley catheter while on anticoagulants 
LP 
(enoxaparin, clopidogrel, and aspirin) 
6.  Inadequate monitoring of gastrointestinal bleeding with blood loss anemia 
LP 
(developing over 8 days) requiring transfusions 
7.  Traumatic catheterization with bleeding following non-function of urinary 
LP 
catheter 
8.  Epistaxis (nasal bleeding) related to nasal cannula while on aspirin  LNP 
9.  Epistaxis (significant nosebleed) with nasal cannula irritation  LNP 
10. Hematoma of groin associated with hemodialysis catheter  LNP 
Venous thromboembolism, deep vein thrombosis, or pulmonary embolism (10) 
1.  Deep vein thrombosis of the lower extremity with inadequate preventive care  LP 
2.  Deep vein thrombosis of upper extremity with suspected infection at 
LP 
intravenous site 
3.  Deep vein thrombosis of lower extremity  LNP 
4.  Deep vein thrombosis of upper extremity associated with PICC line  LNP 
5.  Deep vein thrombosis of upper extremity associated with PICC line  LNP 
6.  Deep vein thrombosis of upper extremity associated with PICC line  LNP 
7.  Deep venous thrombosis of upper extremity associated with PICC line  LNP 
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8.  Non-occlusive deep vein thrombosis of lower extremity  LNP 
9.  Non-occlusive deep venous thrombosis of upper extremity associated with 
LNP 
PICC line 
10. PICC line thrombosis of right upper extremity  LNP 
Skin tear, abrasion, or breakdown (9) 
1.  Urethral erosion with bloody drainage with catheter in place  CP 
2.  Skin maceration from gastric secretions due to PEG leak  LP 
3.  Skin tear and abrasion on sacral area  LP 
4.  Skin tear forearm  LP 
5.  Abdominal wound opened during bathing  LNP 
6.  Multiple skin wounds  LNP 
7.  Skin erosions of lower abdomen and bilateral groin areas  LNP 
8.  Ulcerated lesion of penile meatus with chronic Foley catheterization  LNP 
9.  Skin tear of wrist resulting from tape removal  CNP 
Fall with injury (7) 
1.  Fall with laceration forehead  CP 
2.  Fall with soft tissue hematoma over left maxillary sinus  LP 
3.  Fall resulting in skin tear left wrist and contusion on head  LNP 
4.  Fall with bruising of right eyebrow and right side of face  LNP 
5.  Fall with contusion forehead  LNP 
6.  Fall with forearm abrasion  LNP 
7.  Fall with head contusion  LNP 
Acute kidney injury or insufficiency (3) 
1.  Hyperkalemia secondary to acute kidney injury  LP 
2.  Acute kidney injury  LNP 
3.  Acute kidney injury associated with volume depletion  LNP 
Respiratory issues (other than infections) (3) 
1.  Aspiration of tube feeding  LP 
2.  Aspiration of tube feeding with dyspnea (difficulty breathing)  LNP 
3.  Unstable placement of tracheostomy tube resulting in reliance on BiPAP  LNP 
Volume overload (3) 
1.  Episode of congestive heart failure from fluid overload  LP 
2.  Lower extremity edema due to fluid overload in patient with latent congestive 
LP 
heart failure 
3.  Fluid overload (pulmonary edema) following vigorous intravenous fluids, and 
LNP 
red blood cell administration 
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Constipation, obstipation, or ileus (2)   
1.  Ileus on abdominal x-ray with abdominal pain and inadequate monitoring  LP 
2.  Constipation with nausea  LNP 
Fluid, electrolyte, and metabolic disorders (not medication related) (2) 
1.  Cascade with diarrhea leading to electrolyte imbalance leading to ventricular 
LP 
tachycardia 
2.  Hyperkalemia (potassium of 6.2)  LP 
Other patient-care-related temporary harm events (6) 
1.  Contact dermatitis of lower extremity (tape)  LNP 
2.  Left arteriovenous fistula skin ulcer associated with clotted hemodialysis 
LNP 
catheter 
3.  Pruritus at multiple sites suspected due to contact with adhesion  LNP 
4.  Transfusion reaction  LNP 
5.  Ear pain with drainage post hyperbaric treatment  CNP 
6.  Rash on upper extremities  UTD 
Source: OIG analysis of LTCH stays for 587 Medicare beneficiaries entering an LTCH in March 2014. 
   
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APPENDIX G:  Agency Comments  
CMS Comments 
DEPARTMENT OF HEALTH & HUMAN SERVICES  Centers for Medicare & Medicaid Services 
Administrator 
Washington, DC 20201 
Date:  OCT  1 0 2018 
To:  Daniel R. Levinson 
Inspector General 
Office of InspecGtor vGene. ra l 
From:  Seema Verma 
Administrator  0 
Centers for Medicare & Medicaid Services 
Subject:  Office of Inspector Draft Report: "Adverse Events in Long Term Care Hospitals: 
National Incidence Among Medicare Beneficiaries" (OEl-06-14-00530) 
The Centers for Medicare & Medicaid Services (CMS) appreciates the opportunity to review and 
comment on the OIG draft report on both preventable and not preventable adverse events in 
long-term care hospitals. CMS is committed to identifying adverse events in long-term care 
hospitals and other healthcare settings and improving the quality of care for patients. 
As the report notes, CMS oversees long-term care hospitals' compliance with a set of minimum 
quality and safety standards known as the Conditions of Participation (CoPs). To verify 
compliance with CoPs, on-site surveys are conducted by Medicare-approved accreditation 
organizations or State survey agencies.  CMS provides interpretive guidance, including guidance 
for long-term care settings, to assist in the survey process.  While many of the CoPs have an 
impact on quality, the Quality Assessment and Performance Improvement (QAPI) CoP focuses 
specifically on standards for hospitals to improve quality and safety. As part of the QAPI CoP, 
long-term care hospitals must identify and reduce medical errors and track adverse patient 
events, analyze their causes, and implement preventive actions and mechanisms that include 
feedback and learning through the hospital. 
In addition, as part of eff01is to improve the quality of care in long-term care facilities, the 
Affordable Care Act established the quality reporting program for inpatient long-term care 
hospitals, which requires those providers to submit data on selected quality measures.  Some of 
these selected measures address avoidable adverse events, including the Catheter-Associated 
Urinary Tract Infection Outcome measure. The Improving Medicare Post-Acute Care 
Transformation Act of 2014 also creates new quality reporting requirements for some post-acute 
care providers, including long-term care hospitals. Long-term care hospitals are required to 
report certain data on incidents of major falls, skin integrity, and other quality issues. 
CMS appreciates the OIG's work in this area and past work on adverse events in other settings.   
 
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OIG Recommendation 
AHRQ and CMS should collaborate to create and disseminate a list of potential adverse events in 
LTCHs. 
CMS Response 
CMS concurs with this recommendation. CMS will work with AHRQ to create and disseminate 
a list of potential adverse events in long term care hospitals, similar to its efforts for other patient 
settings. 
OIG Recommendation 
CMS should include information about potential events and patient harm in its quality outreach 
to LTCHs. 
CMS Response 
CMS concurs with this recommendation. CMS will educate providers about potential events and 
patient harm through various channels including, for example, the Medicare Learning Network 
electronic newsletters, quarterly compliance newsletters and webpages, Medicare Administrative 
Contractor webpages, and quality improvement technical assistance by the Hospital 
Improvement Innovation Networks. 
 
 
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AHRQ Comments 
DEPARTMENT OF HEALTH A. D HUMAN SERVICES  Agency for Healthcare 
Research and Quality 
5600 Fishers Lane 
Rockville, MD 20857 
www.ahrq.gov 
To:  Daniel R. Levinson 
Inspector General, 
Department of Health and Human Services 
From:  Gopal Khanna 
Director 
\ 
Agency for Healthcare Research and Quality 
\ 
Subject: OIG Draft Report -Adverse Events in Long-Term Care Hospitals: National 
Incidence among Medicare Beneficiaries (OEI-06-14-00530) 
Thank you for the opportunity to review the draft report entitled, Adverse Events in Long 
Term Care Hospitals: National Incidence Among Medicare Beneficiaries (OEI-06-14-00530) 
We have specific responses to the recommendation. 
I.  Recommendation: AHRQ and CMS should collaborate to create and disseminate 
a list of potential adverse events in LT  CHs. 
AHRQ concurs with this recommendation and will work with CMS to create and disseminate 
a list of potential adverse events in Long-Term Care Hospitals. 
We look forward to following up with you regarding our activities related to the above 
recommendation, as well as to collaborating as appropriate with our colleagues at CMS. 
We believe that your previous reports on adverse events in hospitalized Medicare patients 
have provided valuable information to the public and to Federal and private-sector healthcare 
leaders. This report promises to do the same by addressing a new and especially vulnerable 
patient population. 
If you or your staff has any questions, please feel free to contact Dr. Jeff Brady, Director, 
Center for Quality Improvement and Patient Safety at Jeff.Brady@ahrq.hhs.gov or 301-427-
1322. 
Gopal Khanna 
 
   
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ACKNOWLEDGMENTS 
Amy Ashcraft served as the team leader for this study.  Others in the Office 
of Evaluation and Inspections who conducted the study include 
Nathan Dong, Jennifer Hagen, Jeremy Moore, and Jesse Valente.  Office of 
Evaluation and Inspections staff who provided support include Joe 
Chiarenzelli, Evan Godfrey, Althea Hosein, Christine Moritz, Michael Novello, 
and Melicia Seay.  
This report was prepared under the direction of Ruth Ann Dorrill, Regional 
Inspector General for Evaluation and Inspections in the Dallas regional 
office, and Amy Ashcraft, Deputy Regional Inspector General.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
To obtain additional information concerning this report or to obtain copies, 
contact the Office of Public Affairs at Public.Affairs@oig.hhs.gov.   
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