A report just released by the Office of the Inspector General (OIG 2012) found that, although all hospitals have incident reporting systems and other systems to identify adverse events, only 14% of hospital adverse events get reported. The commonest reasons given for lack of reporting were that the event was not related to an “error” or the event was considered to be an expected outcome or expected adverse event or that any harm involved was considered to be minor or temporary or simply that the hospital had no master list of reportable events. As in all studies of incident reporting, most reports are done by nursing and physicians seldom report adverse events. About a quarter of the adverse events were ones usually reported but were not reported in this instance.
A previous OIG report (Levinson 2010) showed that one in every seven Medicare patients who is hospitalized experienced adverse events during their hospital stays, up to 44% being potentially preventable (see our January 2011 What’s New in the Patient Safety World column “January 2011 No Improvement in Patient Safety: Why Not?”).
The current report was based on a random sample of almost 800 Medicare beneficiaries and used AHRQ Common Formats for identification of events that cause patient harm or near-misses. After identifying events they asked hospitals for any incident reports they had on these events. Hospitals were only able to confirm they had identified events in 14% of the cases identified by the OIG. Hospital administrators classified the remaining events (86 percent) as either events that staff did not perceive as reportable (61 percent) or as events that staff commonly report but did not report in this case (25 percent).
The OIG report also asked state and local regulators and hospital accreditors about what they look for in hospitals as far as event reporting is concerned. Most reported that they look at how the incident reporting is used by hospitals, rather than how it is collected.
While all hospitals are familiar with the CMS list of “never events” and each state has its own list of reportable incidents, many hospitals are not familiar with the AHRQ Common Formats list. This was developed in collaboration with the National Quality Forum (NQF) and the federal Patient Safety Workgroup (PSWG) and includes incidents that reached the patient (whether or not harm occurred), near-misses, and unsafe conditions.
The OIG report recommends that AHRQ and CMS collaborate to create and promote a list of potentially reportable events for hospitals to use and that CMS provide guidance to accreditors regarding their assessments of hospital efforts to track and analyze events. It also recommends that CMS should suggest that surveyors evaluate the information collected by hospitals using AHRQ's Common Formats and CMS should scrutinize survey standards for assessing hospital compliance with the requirement to track and analyze events and reinforce assessment of incident reporting systems as a key tool to improve event tracking. Both AHRQ and CMS have responded that they will collaborate on a list and CMS also stated that it is developing draft guidance for surveyors regarding assessment of patient safety improvement efforts within hospitals.
In the interim, we’d suggest that you become familiar with the AHRQ Common Formats list!
Quite timely on the topic of failure to recognize actual or potential adverse events is an article in the Canadian Medical Association Journal (Daniels 2012). The authors looked at the impact of surveying families of children admitted to a Children’s hospital to see if they saw events they considered to be adverse events. A total of 321 events were identified in 201 of the 544 family reports received. Of these 48% were determined to represent legitimate patient safety concerns. Types of events most often included medication problems, miscommunications (between staff or between staff and families), and equipment problems. Only 8 of the adverse events reported were also reported by health care providers. There was also little change in reporting by health care providers after implementation of the family reporting system.
The Daniels article demonstrates that the perspectives of families and health care workers may differ regarding adverse events or near misses. Importantly, it shows that some of the barriers that prevent health care workers from reporting adverse events or near misses may not apply to families. Such family reporting systems therefore provide an opportunity (another set of eyes and ears) to identify potential patient safety issues in need of improvement.
Incidentally, in the Daniels study families noted that apologies were given only in a minority of cases but, when they were given, they were usually considered adequate. See our prior columns on disclosure and apology (June 22, 2010 Patient Safety Tip of the Week “Disclosure and Apology: How to Do It” and our November 2010 What’s New in the Patient Safety World column “). ”
Families responding to the surveys also readily volunteered to participate in future safety improvement initiatives by the hospital.
So in addition to removing barriers to adverse event reporting for staff, consider using other tools (such as the family adverse event reporting tool discussed above) to better identify patient safety concerns in your facilities. Such a tool may not only help you identify more opportunities to improve but likely also has a positive impact on patient and family satisfaction.
OIG (Office of the Inspector General. Department of Health and Human Services). Hospital Incident Reporting Systems Do Not Capture Most Patient Harm. January 2012
AHRQ. Patient Safety Organizations. Common Formats.
Levinson DR. Adverse Events in Hospitals: National Incidence Among Medicare Beneficiaries. Washington, DC: US Department of Health and Human Services, Office of the Inspector General; November 2010. Report No. OEI-06-09-00090
Daniels JP, Hunc K, Cochrane DD, et al. Identification by families of pediatric adverse events and near misses overlooked by health care providers. CMAJ 2012; 184: 29-34
Last month (see our January 2012 What’s New in the Patient Safety World column “Need for New Transfusion Criteria?”) we reported on results of the FOCUS study (Carson 2011) which showed essentially no difference in outcomes between a restrictive transfusion policy and a liberal one in patients undergoing surgery for hip fracture. And in our March 2011 What’s New in the Patient Safety World column “Downside of Transfusions in Surgery” we discussed the mounting evidence that transfusions during surgery are associated with increased morbidity and mortality. We also noted that some performance improvement programs were successful in reducing the frequency of transfusions and resulted in considerable cost savings.
Now another new study (Ferraris 2012) demonstrates that transfusions have a dose-dependent adverse effect on outcomes in patients undergoing surgery. The study used data from the Amercian College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database. They looked at patients who received intraoperative transfusion of one unit of packed RBC’s and those transfused with several units, and compared them to propensity-matched controls who were not transfused. They found that even those receiving just one unit of packed RBC’s (which they considered possibly “discretionary”) had increased mortality, morbidity, and resource use and adverse events increased in a dose-dependent manner with more transfusions given. There were increased wound problems, pulmonary complications, sepsis, and postoperative renal dysfunction in the transfused groups. Many of the adverse events were infectious complications.
The authors discuss potential reasons that transfusion may cause these adverse effects, including that transfusions have an immunosuppressive effect on the recipient. And they point out that there is little physiological rationale for using such “minimal” transfusions in these surgical patients.
There is now a substantial body of evidence showing harmful effects from transfusion and little evidence of benefit in patients undergoing surgery who are not “symptomatic” from their anemia. In particular, the practice of transfusing “minimal” amounts of blood during surgery is one that must be strongly reconsidered. Again, most hospitals have an opportunity here to both improve patient outcomes and save valuable resources at the same time.
Carson JL, Terrin ML, Noveck H, et al. Liberal or Restrictive Transfusion in High-Risk Patients after Hip Surgery. NEJM 2011; published online first December 14, 2011
Ferraris VA, Davenport DL, Saha SP, et al. Surgical Outcomes and Transfusion of Minimal Amounts of Blood in the Operating Room. Arch Surg 2012; 147(1): 49-55
In several of our prior columns on use of oxygen (see our Patient Safety Tips of the Week April 8, 2008 “Oxygen as a Medication” and January 27, 2009 “Oxygen Therapy: Everything You Wanted to Know and More!”) we have commented that in the past we often routinely gave oxygen to patients with myocardial infarction or stroke. But such use was more reflexive in nature and not evidence-based.
In our July 2010 What’s New in the Patient Safety World column “Cochrane Review: Oxygen in MI” we discussed a Cochrane Review (Cabello 2010) which suggested that not only is oxygen not likely beneficial in acute MI patients, it may even cause harm. They reviewed the literature but could find only 3 randomized trials of oxygen vs. room air in MI patients. Only 387 patients were included in these 3 trials and only 14 patients died. The pooled relative risk for death was almost 3.00 in the oxygen group but the confidence interval was wide. The authors concluded that there is no evidence to support the routine use of oxygen in the acute MI patient. They suggest that the issue of whether oxygen is harmful could only be answered in a more definitive randomized trial.
Around the same time another study (Kilgannon 2010) demonstrated that the use of hi-dose oxygen in post-cardiac arrest patients had a deleterious effect.
In recent months several reviews have again challenged the conventional practice of giving oxygen routinely to all patients with suspected MI, regardless of whether hypoxemia has been demonstrated. Kones (Kones 2011) reviewed the literature and presented the history, physiology, and clinical evidence (or lack thereof!) for the practice of giving oxygen in MI patients. He discusses the assumptions underlying the practice and some weak historical evidence that supported the practice, then discusses modern physiological knowledge of the effects of hyperoxygenation and the clinical evidence suggesting that hyperoxygenation may be harmful. He discusses the status of recommendations about oxygen in current guidelines and notes the importance of doing a large randomized controlled trial (which is apparently in progress). Kones also voices concern about the editorial (Atar 2010) accompanying the Cochrane review. That editorial had argued that the quality of the studies included in the Cochrane review was poor and that the study did not conclusively demonstrate increased mortality from oxygen and that with no strong current evidence of a deleterious effect of oxygen, treatment of MI patients with oxygen is still merited. Kones, on the other hand, argues that oxygen is indicated in MI patients who are hypoxemic and target oxygen saturations should be in the 94-96% range and that hyperoxia should be avoided until such time that more definitive studies are done.
A second recent paper (Cornet 2012) looks at use of supplemental oxygen in a variety of medical emergencies and notes the collective evidence argues against routine use of oxygen in most emergencies. Instead, they recommend a policy of careful, titrated oxygen supplementation. They discuss the previously mentioned MI data and the Kilgannon study on post-resuscitation hyperoxia. Then they discuss the data on oxygen use in stroke and COPD. They conclude that evidence suggests potential detrimental effects of hyperoxygenation and recommend that, when it is indicated, oxygen therapy should be titrated carefully and cautiously.
One other area in which use of hyperoxygenation has been of interest deals with surgical site infections. However, the PROXI study (Staehr 2011) showed that use of 80% vs. 30% O2 in obese patients undergoing abdominal surgery did not reduce the SSI rate. Though it did not show any difference in pulmonary complications or other adverse events between the groups, it failed to demonstrate any positive value of hyperoxygenation.
Hospitals need to look at their existing protocols (and actual practices) for managing a variety of medical conditions where oxygen use may be considered. How many of you have standardized order sets that directly (or indirectly by poor use of checkboxes) encourage inappropriate use of oxygen in MI or stroke patients? Going back to our Patient Safety Tips of the Week April 8, 2008 “Oxygen as a Medication” and January 27, 2009 “Oxygen Therapy: Everything You Wanted to Know and More!” we strongly support facilities doing audits of their oxygen practices. You’ll probably be surprised at the opportunities you uncover to improve practices (and save money at the same time!).
In addition, in many cases high doses of oxygen are administered by the pre-hospital emergency response teams. Making them aware of the potential dangers is also important.
Cabello JB, Burls A, Emparanza JI, Bayliss S, Quinn T. Oxygen therapy for acute myocardial infarction. Cochrane Reviews 2010; Published online June 16, 2010
Kilgannon JH, Jones AE, Shapiro NI et al. Association
Between Arterial Hyperoxia Following Resuscitation From Cardiac Arrest and
JAMA. 2010; 303(21): 2165-2171
Kones R. Oxygen therapy for acute myocardial infarction-then and now. A century of uncertainty. Am J Med. 2011; 124(11): 1000-1005
Atar D. Should oxygen be given in myocardial infarction? BMJ 2010; 340: c3287 (Published 17 June 2010)
Cornet AD, Kooter AJ, Peters MJL, Smulders YM. Supplemental Oxygen Therapy in Medical Emergencies: More Harm Than Benefit? (Research Letter). Arch Intern Med 2012; published online January 9, 2012
Staehr AK, Meyhoff CS, Rasmussen LS, PROXI Trial Group. Inspiratory Oxygen Fraction and Postoperative Complications in Obese Patients: A Subgroup Analysis of the PROXI Trial. Anesthesiology 2011; 114(6): 1313-1319
Aspiration pneumonia is one of the biggest risks in patients with stroke. Our June 26, 2007 Patient Safety Tip of the Week “Aslanyan 2004, Hinchey 2005). The human and financial impact of pneumonia in the acute stroke patient are substantial. The occurrence of pneumonia was associated with about $15,000 incremental cost per case (Katzan 2007) and pneumonia increased the risk of dying within 30 days threefold in patients with acute stroke, after correction for severity of the stroke (Katzan 2003).“ focused on the evaluation of stroke patients for dysphagia prior to feeding them. Much of the morbidity and mortality in patients with acute stroke is related not just directly to the neurological deficit but rather to the complications such as pneumonia. The incidence of pneumonia in the acute stroke population varies considerably in the literature, largely because of stroke populations of varying severity and differences in definitions used. However, studies that have looked at stroke patients having at least some degree of paralysis present have noted incidences of pneumonia typically in the 12-13% range (
Use of a formal dysphagia screening tool has been shown to reduce the risk of pneumonia in stroke patients by as much as half (Hinchey 2005) and there are reports showing that hospitals can increase their compliance with swallowing assessment by using preprinted order sets and by using written care protocols (Hinchey 2006, Book 2006).
We were very disappointed when NQF waffled in 2008 on including swallowing assessment in stroke patients as one of its quality measures (NQF presumably was concerned because the evidence base was not robust enough). Nevertheless, swallowing assessment has been part of the American Heart Association/American Stroke Association guidelines for management of the acute stroke patient and has been a quality standard for The Joint Commission accreditation of Stroke Centers. But there has been little change in the evidence base for assessment and management of dysphagia in the stroke patient since then.
Our June 15, 2010 Patient Safety Tip of the Week “Dysphagia in the Stroke Patient: the Scottish Guideline” discussed the excellent Scottish Intercollegiate Guidelines Network guideline “Management of patients with stroke: identification and management of dysphagia.A national clinical guideline.” This is the most comprehensive such guideline we’ve seen. It reviews the evidence base and makes recommendations not only for the assessment of dysphagia in the stroke patient but provides great recommendations about interventions in the dysphagic patient, nutritional status of the stroke patient, issues related to tube feedings, medication issues in the dysphagic patient, oral hygiene in the stroke patient, and training of both professional staff and lay caregivers in important issues. It also provides good advice about implementing and auditing the guideline and has a variety of useful tools in its appendix section.
The Scottish guideline uses a water swallow test as a screening tool for dysphagia, then follows up abnormal tests with formal videofluoroscopic studies.
Yet the ideal screening tool remains elusive. A new study (Schepp 2011) shows we have not come a long way in identifying the best dysphagia screening tool. They identified 35 dysphagia screening tools in the literature but found only four that met the basic criteria of reliability, validity and feasibility. Each of the 4 protocols had sensitivities of at least 87% and negative predictive values of at least 91% (compared to the gold standard of a formal swallowing evaluation/videofluoroscopy).
Two of the 4 had been validated only in small samples. Of the remaining two, one (the Toronto Bedside Swallowing Screen Test) had been validated in multiple acute care and rehabilitation settings but was proprietary. The Barnes Jewish Hospital Acute Stroke Dysphagia Screen was validated in over 300 patients, requires minimal training, is easily administered, and has reasonable sensitivity and specificity.
The team discusses many of the challenges associated with dysphagia screening tools. Not only do they need to be valid, reliable and easy to administer but you also need to demonstrate that use of these tools actually leads to desired outcomes (fewer aspiration pneumonias, shorter lengths of stay, better QOL, lower mortality, etc.) and that they are cost-effective. They also stress the importance of false positive screening tests. They note that 23-46% of patients screened had false positive results, often leading to placement of feeding tubes or unnecessary withholding of oral feeds.
On a related note, the American Association of Critical-Care Nurses has recently released a practice alert on prevention of aspiration in critically-ill patients (AACN 2011). This evidence-based alert notes that microaspiration is very common in ICU patients, particularly those with various feeding tubes. They list 7 interventions that should be considered in such patients and summarize the levels of evidence for each.
Aslanyan S, Weir CJ, Diener H-C, Kaste M, Lees KR. Pneumonia
and urinary tract infection after acute ischaemic stroke: a tertiary analysis
of the GAIN international trial. Eur J Neurology 2004; 11: 49-53
Hinchey JA, Shephard T, Furie K, Smith D, Wang D, Tonn S. Formal Dysphagia Screening Protocols Prevent Pneumonia. Stroke 2005; 36: 1972-1976 http://stroke.ahajournals.org/cgi/content/abstract/36/9/1972?maxtoshow=&hits=10&RESULTFORMAT=&fulltext=hinchey&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT
Katzan IL, Dawson NV, Thomas CL, Votruba ME Cebul RD. The
cost of pneumonia after acute stroke. Neurology 2007; 68:1938-1943
Katzan IL, Cebul RD, Husak SH, Dawson NV, Baker DW. The
effect of pneumonia on mortality among patients hospitalized for acute stroke.
Neurology 2003; 60:620-625
Hinchey JA, Shephard TJ, Tonn S, Ruthazer R. Preprinted Orders Are Associated With High Adherence to Processes Required on Admission: P468. Stroke 2006; 37: 739
Book DS, Dostai J, Sama D. Compliance with Written Care Protocols Predicts Success in Achieving JCAHO Stroke Performance Measures: P469. Stroke 2006; 37: 739
Adams HP, del Zoppo G, Alberts MJ et al. Guidelines for the Early Management of Adults With Ischemic Stroke: A Guideline From the American Heart Association/ American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: The American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists.
Stroke 2007; 38;1655-1711; originally published online Apr 12, 2007;
The Joint Commission. Primary Stroke Center Certification.
Scottish Intercollegiate Guidelines Network. Management of patients with stroke: identification and management of dysphagia.A national clinical guideline. June 2010
Quick Reference Guideline
Schepp SK, Tirschwell DL, Miller RM, Longstreth WT. Swallowing Screens After Acute Stroke: A Systematic Review. Stroke 2011; published online before print December 8 2011
Edmiaston J, Connor LT, Loehr L, Nassief A. Validation of a Dysphagia Screening Tool in Acute Stroke Patients. Am J Crit Care 2010; 19: 357-364
AACN (American Association of Critical-Care Nurses). Prevention of aspiration practice alert. November 2011
And while you are improving patient outcomes and saving money on unnecessary oxygen therapy and transfusions (see the above February 2012 What’s New in the Patient Safety World colums “More Bad News on Transfusions” and “More Evidence of Harm from Oxygen”), consider also taking the advice of an American College of Physicians consensus (Qaseem 2012) on avoiding certain screening and diagnostic tests that are of low value.
That group put together a list of 37 tests or testing scenarios that they do not consider to be high-value cost-conscious care. Examples:
The group used several principles to frame their questions about the value of testing in various clinical scenarios, including:
· Will the test results likely change management of the patient’s care?
· Is the likelihood of a false positive test higher than that of a false negative test (for low probability pretest conditions) and would false positive results likely lead to further testing or treatment that might be harmful?
· What are the downstream costs that occur after a test?
The editorial accompanying the article (Laine 2012) adds a couple other pertinent questions to ask before ordering tests:
· Did the patient have the test previously? If so, is there really a need to repeat it? Or can I just get the result of the test done elsewhere?
· What is the potential danger over the short term if I do not order the test?
· Am I ordering this test primarily because the patient wants it or to reassure the patient?
We suspect they would have added a 38th practice to avoid had a study published in the New England Journal of Medicine this January (Gourlay 2012) been available. While the ACP group recommended not screening for osteoporosis routinely in women under the age of 65 with no risk factors, they had no recommendations about repeat screening for osteoporosis in women aged 65 and older. The new study analyzed almost 5000 women in the Study of Osteoporotic Fractures (SOF) who were age 67 or older, had normal bone density or osteopenia at entry and no fractures and were followed prospectively for at least 15 years. They were able to estimate that osteoporosis would develop in less than 10% of older postmenapausal women during rescreening intervals of about 15 years for women with normal bone density or mild osteopenia, 5 years for women with moderate osteopenia, and one year for women with advanced osteopenia. It is likely that these will serve as guidelines to help reduce the number of unnecessary repeat bone densitometry testing.
There are many opportunities to reduce health care costs while preserving or improving patient outcomes. Practices like these and the ones noted in the recent article “Principles of Conservative Prescribing” (Schiff 2011) are common sense approaches that are evidence-based that we can all apply to all our patients.
Qaseem A, Alguire P, Dallas P, et al. Appropriate Use of Screening and Diagnostic Tests to Foster High-Value, Cost-Conscious Care. Ann Intern Med 2012; 156: 147-149
Laine C. High-Value Testing Begins With a Few Simple Questions. Ann Intern Med 2012; 156: 162-163
Gourlay ML, Fine JP, Preisser JS, et al. for the Study of Osteoporotic Fractures Research Group. Bone-Density Testing Interval and Transition to Osteoporosis in Older Women. N Engl J Med 2012; 366 :225-23
Schiff GD, Galanter WL, Duhig J, et al. Principles of Conservative Prescribing. Arch Intern Med. Published online June 13, 2011
In our efforts to reduce unnecessary hospital admissions and readmissions we often find that many patients are coming to the hospital emergency department from skilled nursing facilities or other long-term care facilities. And we often find that such visits could have been avoided had there been access to more medical evaluation and management at those SNF/LTC’s.
Those trips to the ED may be inconvenient for patients and are costly in terms of transportation and time required for staff involvement. Now there is an even more cogent argument for making such resources available at those sites and avoiding trips to the ED. A Canadian study (Quach 2012) has found that the rate of new respiratory or GI infections is almost 4 times higher in LTC residents in the week following a visit to the ED. They note that this puts the entire SNF/LTC at risk for an outbreak of infection and suggest it might be reasonable to exercise additional precautions for 5-7 days for patients returning from ED visits.
The authors don’t state what those additional precautions might be. However, one might anticipate they would include some measures to limit those patients interacting with other patients (eg. taking meals in room rather than in a group setting) and perhaps some sort of contact isolation procedures. But you need to beware that these precautions may also have unintended consequences. In particular, residents of LTC facilities tend to be more prone to delirium and we might see more delirium in patients put on these precautions (see our January 17, 2012 Patient Safety Tip of the Week “Delirium and Contact Isolation”).
Quach C, McArthur M, McGeer A, et al. Risk of infection following a visit to the emergency department: a cohort study. CMAJ 2012; January 23, 2012