Healthcare Consulting Services
April 5, 2016
Workarounds Overriding Safety
Way back in our June 17, 2008 Patient Safety Tip of the Week “Technology Workarounds Defeat Safety Intent” we described how healthcare workers employ workarounds that may make their work faster or easier but in doing so they defeat the intent of technologies to prevent errors and ensure safe patient care. In that column we focused on workarounds related to bedside medication verification (barcoding) systems.
Another common workaround is related primarily to the automated dispensing cabinet (ADC). A recent Pennsylvania Patient Safety Advisory reported on overrides related to ADC’s (Grissinger 2015). Grissinger reviewed 583 events reported to the Pennsylvania Patient Safety Reporting System over a 2-year period related to overrides. Though over three quarters of these reached the patient, harm occurred in only 0.3% of cases. Grissinger notes that 75% of overrides occurred with ADC’s, though overrides were also noted during CPOE or pharmacist order entry (12%) or barcoding (7.5%).
The most common ADC override was unauthorized medications (i.e. obtaining a medication for a patient without a prescribed order), followed by wrong patient events and wrong dosage form events. Over 30% of the unauthorized medication events involved high-alert medications. Of all the medications involved, antibiotics and opioids headed the list but of the high-alert medications, opioids, anticoagulants and insulin were most commonly involved.
Interestingly, ADC overrides were more common on medical and surgical units rather than ICU’s or the ER where you might expect more emergent situations to make them more frequent. Patients age 65 and older appeared to be disproportionately affected.
Grissinger notes that one critical element of the safety protections bypassed particularly via the ADC overrides is review by a pharmacist. He notes that most hospitals have lists of medications for which overrides in ADC’s are allowable (so nurses may remove drugs from the ADC for urgent situations). The logic is that certain drugs may be urgently needed and cannot wait for pharmacist approval. But he notes that removal of a drug from an ADC might be necessary under some conditions but not under others. Yet such “lists” don’t differentiate those conditions. Virtually all ADC’s today maintain “override logs”. These should be reviewed regularly for appropriateness and medication errors should be reviewed against these override logs as well.
What’s missing in the override logs is the reason for each override. You’ve heard us say over and over that identification of workarounds is important because there is virtually always a reason staff are using workarounds (i.e. a system issue). Therefore, review of the override logs is critical to identifying what circumstances are leading to use of those overrides and what system problems might need to be fixed.
Another common workaround getting lots of attention recently is copying and pasting. Almost all physicians copy and paste in the EMR, particularly when doing daily progress notes on inpatients. That’s because the key elements in a daily progress note are usually the same from day to day except that the data about each element may differ. For example, a progress note about a patient with an infection might begin with a comment about their maximum temperature (eg. Tmax = 38.6º), followed by comments about symptoms related to the infection, and results of lab or microbiology tests. So it would be common to copy yesterday’s progress note, paste it under today’s date and update the specific elements. But problems arise when a previous note is simply copied and no update is performed.
The same applies to use of templates or macros in the EMR. One account of the famous early case of Ebola in the US (Hawryluk 2016) notes that the ER physician used a template but failed to update that template with the current patient temperature. Ebola was thus not immediately considered and the patient was discharged.
Concerns about copy-and-paste issues began to appear in the early days of EMR’s. Veterans Affairs facilities had some of the earliest EMR’s and in 2003 Hammond and colleagues (Hammond 2003) reported on the prevalence and dangers of copy-and-paste. They noted that 9% of progress notes had some form of copied or duplicated text. While they noted most instances were benign, they found that “high-risk author copying” occurred once for every 720 notes, but one in ten electronic charts contained an instance of high-risk copying. This included introduction of misleading errors into the EMR that were potentially unsafe. They note how such errors then may get propagated through the EMR.
In a seminal paper on the benefits and dangers of copy-and-paste Weis and Levy (Weis 2014) pointed out that the issue is bigger than copy-and-paste and includes macros, templates, automated data importation, “copy note forward”, and other methods by which information might move from one place to another in the EMR. They called these methods collectively “Content-Importing Technologies (CIT)”. They noted that aside from the perceived efficiencies derived from use of CIT, there were other potential benefits. For example, data entered into specific fields through templates may help with clinical research and CIT might help track specific problems longitudinally in a complex medical record. CIT might also help with discharge summaries and discharge instructions.
But they then listed the potential dangers of CIT. Medication and allergy lists that were not reviewed with patients and updated could propagate errors. Symptoms or histories of present illness might incorrectly be attributed to different times. And the use of macros and templates for physical exams raised the question as to whether all elements of the physical exams really had been performed. They also cite the study by Singh and colleagues on diagnostic error in primary care (Singh 2013) that showed practitioners copied and pasted previous progress notes into the index visit note in 7.4% of cases and, of these cases, copying and pasting mistakes were determined to contribute to more than one-third (35.7%) of errors.
Weis and Levy also note the legal and regulatory dangers of CIT, noting that Medicare has stated it will be auditing for “cloned” documentation that might represent fraud and abuse.
Our January 12, 2016 Patient Safety Tip of the Week “New Resources on Improving Safety of Healthcare IT” cited an excellent contribution on patient safety problems related to healthcare information technology (IT) based on a review of malpractice claims (Graber 2015). One of the themes in the Graber study was that, largely because of cut-and-paste capabilities or ability to pre-populate data, incorrect information may be propagated in the medical record. For example, importing a previous medication list might include medications the patient is no longer taking. Or omission of a medication on a medication list may result in continued omission of that medication in the future. They also emphasized the well-known risks of overriding alerts and employing workarounds.
The problems related to “copy-and-paste” workarounds have become so prominent that ECRI Institute, in conjunction with multiple other patient safety organizations (Partnership for Health IT Patient Safety), recently came out with a toolkit for safe use of copy and paste (ECRI Institute 2016). This culminated in four safe practice recommendations:
The toolkit also notes that many templates have been created to prompt physicians to include elements needed to maximize billing. This (and other reasons for CIT) has led to chart “bloating” in which notes and other documentation lead to larger and larger medical records.
The Partnership toolkit is well referenced and has links to excellent resources. It provides sample policies and procedures, audit tools, education and training materials, checklists and good guidelines and action plans for how organizations should go about implementing the above recommendations.
Practices and organizations need to evaluate the workarounds (in barcoding, overrides, copy-and-paste, and others) that are occurring and potentially endangering patient care. They need to do risk assessments of such practices and implement the tools provided in some of the above mentioned resources.
See some of our other Patient Safety Tip of the Week columns dealing with unintended consequences of technology and other healthcare IT issues:
Grissinger M. Medication Errors Involving Overrides of Healthcare Technology. Pa Patient Saf Advis 2015; 12(4): 141-148
Hawryluk M. Report highlights errors caused by copying, pasting in medical records. Houston Chronicle 2016; March 12, 2016
Hammond KW, Helbig ST, Benson CC, Brathwaite-Sketoe BM. Are Electronic Medical Records Trustworthy? Observations on Copying, Pasting and Duplication. AMIA Annu Symp Proc 2003; 2003: 269-273
Weis JM, Levy PC. Copy, Paste, and Cloned Notes in Electronic Health Records: Prevalence, Benefits, Risks, and Best Practice Recommendations. Chest 2014; 145(3): 632-638
Singh H, Giardina TD, Meyer AND, et al. Types and Origins of Diagnostic Errors in Primary Care Settings. JAMA Intern Med 2013; 173(6): 418-425, published online February 25, 2013
Graber ML, Siegal D, Riah H, et al. Electronic Health Record-Related Events in Medical Malpractice Claims. Journal of Patient Safety 2015; Published Ahead-of-Print November 6, 2015
ECRI Institute. Health IT Safe Practices: Toolkit for the Safe Use of Copy and Paste. Accessed February 29, 2016
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April 12, 2016
Falls from Hospital Windows
The patient names were different and the hospital names were different but the two cases were otherwise almost identical. Last month a 43-year-old man died after falling from the window of his sixth-floor hospital room at a Maine hospital. The patient was recovering from a motorcycle accident earlier in the month in which he suffered a traumatic brain injury. He apparently had been in a medically-induced coma for a period but was recovering and getting ready for rehab. The patient’s daughter believes her father was not suicidal, but was disoriented and trying to get home to his family (Byrne 2016). “He wanted nothing more in the world than to come home with the family, but with the extent of his brain injuries he needed more hospital time and rehab before that could happen.” “All he could focus on was getting home, and due to his state of mind he was willing to try anything to get out of that hospital. He was able to open his hospital window enough to get out,” she wrote.
This case sounds eerily similar to one we described in our October 6, 2015 Patient Safety Tip of the Week “Suicide and Other Violent Inpatient Deaths”. That case involved a 26-year old male patient in Pennsylvania who had suffered a head injury in a motorcycle accident (Darragh 2014a). He was said to have an “impulse control disorder” following the head trauma and was on continuous observation by a hospital security guard in an ICU when he entered the bathroom and locked the door. He then smashed double-paned locked windows and jumped to his death from the sixth floor. The guard had not received the same training that nurses who usually provide continuous observation would have had. Such would have required continued observation of the patient in the bathroom at least via a partially open door.
According to the Portland (Maine) Press Herald report (Byrne 2016), newly constructed hospital facilities in Maine must meet the American Institute of Architects 2006 general guidelines for hospitals, which doesn’t require windows in patient rooms to be openable. However, if windows in patient rooms are able to be opened, “operation of such windows shall be restricted to inhibit possible escape or suicide,” the standards state. Those new standards may not have applied to the hospital section in which the patient in this case was housed.
Another critical factor we see over and over is that there may be inadequate training for those charged with close monitoring or observation of patients. This is especially the case on med/surg floors when patients are identified as being at high risk for suicide, other self-harm, or wandering and elopement.
In the Pennsylvania case the patient had been hospitalized and four times tried to leave the hospital against medical advice (Darragh 2014b). He was successful twice and was picked up by police and returned to the hospital. Previous attempts at elopement are a risk factor for subsequent elopements (see our July 28, 2009 Patient Safety Tip of the Week “Wandering, Elopements, and Missing Patients”).
In patients committing suicide, we often see that a period of greater vulnerability when their depression is improving. The same probably applies to the patient with traumatic brain injury (TBI) and staff need to be aware that the impulsivity often seen after TBI accompanied by the desire to go home can lead to the sort of disastrous consequences unfortunately seen in these two cases.
Most of you are familiar with patients having dementia or Alzheimer’s disease who may be prone to wandering and elopement. But any patient with impaired cognition may be at risk. This includes patients with psychiatric disorders, developmental disabilities, and acquired neurological disorders such as traumatic brain injury (TBI).
Some standardized questions that appear on most wandering assessment tools are:
A prior history of wandering or elopement (eg. at a long-term care facility prior to admission) should be a red flag.
Others have emphasized “exit-seeking behavior” such as talking about going home or asking about things not available on the unit (typically something such as candy bars). But there are other risk factors or contributing factors as well. Many of the drugs we’ve talked about under delirium (particularly sedating agents) may contribute.
Just as with fall risk assessments or delirium risk assessments or even DVT risk assessments, things change during a hospitalization. Therefore, a single assessment for elopement or wandering risk on admission is not sufficient. That risk assessment must be repeated after surgery, at internal transfers of care, and any time there has been a significant change in the patient’s mental status or overall medical status.
We’ve also often discussed that intrahospital patient transports may also be vulnerable events. You’ve heard us talk on several occasions about the “Ticket to Ride” concept in which a formal checklist is completed for all transports (eg. to radiology). Such checklists typically contain information related to adequacy of any oxygen supplies and medications needed but should also include information about things like suicide risk and wandering/elopement risk. These all need to be conveyed to the caregiver who may be accepting the patient in the new area. Just as we’ve talked about cases where a patient may attempt suicide in a bathroom in the radiology suite that is not suicide-proofed, a patient at risk for wandering or elopement may wander off easily while waiting in the radiology suite if not appropriately supervised.
Behavioral health units and staff are usually attuned to the risk of patients eloping or attempting suicide. But these cases illustrate that staff on med/surg units or ICU’s or rehab units also need to be aware of risk factors for wandering, elopement, suicide or other impulsive behavior. Doing risk assessments and ensuring that staff caring for at-risk patients are adequately trained in dealing with such patients is important. When high-risk patients are identified it is also important to ensure they are not left alone in rooms with windows that can be opened (or broken) by patients.
Some of our prior columns on preventing hospital suicides:
See our previous columns on wandering, eloping, and missing patients:
Byrne M. Daughter: Fall victim at Maine Medical Center wasn’t suicidal, was probably disoriented. Portland Press Herald 2016; March 31, 2016
Darragh T. State: St. Luke's staff not properly trained to monitor man who jumped to death from hospital window. The Morning Call (Allentown, PA) August 6, 2014
Darragh T. Death at Pa. facility highlights security challenge for hospitals. The Morning Call (Allentown, Pa.) June 21, 2014
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April 19, 2016
Independent Double Checks and Oral Chemotherapy
Our May 5, 2015 Patient Safety Tip of the Week “Errors with Oral Oncology Drugs” pointed out that, with the recent proliferation of oral chemotherapy agents, we are beginning to see more and more patient safety issues arising from their use. One facet we only briefly touched upon in that column was the use of independent double checks.
One of our most frequently accessed columns is our October 16, 2012 Patient Safety Tip of the Week “What is the Evidence on Double Checks?”. Usually when we are talking about independent double checks we are referring to such checks being done at the same stage of the medication continuum (eg. during ordering or during preparation). But medication safety also includes another type of independent double check at several levels. For example, in a hospital medications ordered by a physician or other prescriber are typically checked by a pharmacist and nurse at different times. In our November 3, 2015 Patient Safety Tip of the Week “Medication Errors in the OR – Part 2” we noted one of the reasons for more medication errors in the OR is that the anesthetist is often the one choosing a medication, preparing it, and administering it, thereby lacking those independent checks that might occur elsewhere.
While we’ve pointed out the limitations of double checks in several columns, we still recommend independent double checks for high alert drugs. In the hospital, chemotherapy agents are high alert drugs that get such attention. But what happens outside the hospital? Particularly as more and more oral chemotherapy agents are being developed and used, do they get the same degree of scrutiny that is typically done for IV chemotherapy agents? A new study (Griffin 2015) suggests no. Griffin and colleagues in Canada compared the performance of independent double checks for oral vs. intravenous chemotherapy and found striking differences. Using direct observation by two human factors experts and semi-structured interviews they found 57 systematic checks for IV chemotherapy compared to only 6 for oral chemotherapy. Systematic checks required the check be done clearly as a part of a qualified healthcare provider’s (HCP) role, be done consistently, and be done with all the information necessary to inform such a check. They defined “partial” checks if one of those elements was missing. Even when they included “partial” checks, the results were 64 checks for IV chemotherapy vs. only 17 for oral chemotherapy.
For IV chemotherapy there were checks at multiple levels (planning, ordering, and dispensing). So for IV chemotherapy there were several opportunities for a qualified HCP to identify and mitigate an unintentional error before it reached the patient. Not so for oral chemotherapy. Often the only qualified HCP with an opportunity to intercept an error was the community pharmacist and these were in the ordering and dispensing phases only. And those community pharmacists were often lacking critical information. They often did not even have access to critical information such as the type of cancer the patient had.
Though this was a Canadian study, the authors cite studies from the US (Weingart 2007) that showed few of the safeguards routinely used for infusion chemotherapy have been adopted for oral chemotherapy at US cancer centers and lack of consensus at these centers about safe medication practices for oral chemotherapy.
In our May 5, 2015 Patient Safety Tip of the Week “Errors with Oral Oncology Drugs” we discussed an analysis of incidents involving oral chemotherapy agents in Canada (ISMP Canada 2015). They analyzed 516 incidents over a 12 year period and while patient harm or death occurred in only a small minority of cases there were multiple lessons learned. They were able to identify 3 major themes: (1) lack of specialized knowledge by care providers (2) medication name mix-ups and (3) lack of safe medication handling processes. Under the first theme ISMP Canada noted that chemotherapy regimens can be very complex and that community pharmacists may not have a good understanding of chemotherapy cycles, side-effect profiles, etc. The same applies to many other non-oncologist healthcare professionals. As a result, patient education on these complex issues may be insufficient. The example they provide is a patient who was on a protocol-defined capecitabine cyclical dosing regimen who was mistakenly given capecitabine daily when admitted as an inpatient and then the prescription given the patient at discharge also erroneously called for daily capecitabine. You may recognize this problem of prescribing a drug daily rather than on a different regimen because we’ve written about very similar problems with methotrexate in the past (see our What’s New in the Patient Safety World columns for July 2010 “Methotrexate Overdose Due to Prescribing Error” and July 2011 “More Problems with Methotrexate” and February 2016 “Avoiding Methotrexate Errors”).
As a subtheme of the “lack of specialized knowledge” they mention that failure to include some critical information on the prescriptions may contribute. Such information might include diagnosis, patient height and weight, duration of the chemotherapy cycle, etc.
We also cited a classic article on medication errors related to oral chemotherapy (Weingart 2010). Weingart and colleagues warned that the use of oral chemotherapy was expanding and that few of the safeguards that apply to prescribing, dispensing and administering IV chemotherapy have been applied to oral chemotherapy. They identified issues with oral chemotherapy from a variety of sources. They identified over 500 such errors, including 99 actual adverse drug events. While many of the remaining events were near-misses they did provide the opportunity for patient harm and thus were helpful in identifying potential vulnerabilities. Importantly, they identified that over half the errors (55.9%) were intercepted, preventing actual patient harm. Of those intercepted, this was most often by a pharmacist (69.5%), followed by patient or family (10.2%) or nurse (6.9%). Wrong dose errors were most frequent but wrong drug and missed dose errors also occurred. But one particularly salient problem was supplying the wrong number of days. Whereas the majority of errors involving wrong dose, wrong drug, or missed dose resulted in near misses, 39.3% of errors involving wrong number of days supplied resulted in adverse drug events. We went on in that column to discuss several other instances of pharmacies supplying the wrong number of days or doses for oral chemotherapy.
So now that we’ve identified lack of double checks as a vulnerability for oral chemotherapy, how do we address it? One is to ensure that a pharmacist with access to all critical clinical information and a thorough understanding of both the particular cancer and the chemotherapy regimen is involved as a potential double checker. Unfortunately, this may mean that some community pharmacists and mail order pharmacies are not the most appropriate for patients on oral chemotherapy regimens. Anyone who has picked up a prescription at a community pharmacy will recognize how busy the pharmacist is, further increasing the vulnerability to errors. And very often there is only a single pharmacist working. So there is no opportunity for a double check. The only barrier left to intercept the error is the patient him/herself (or their family/caregiver). So one consideration would be to ensure that prescriptions for oral chemotherapy are only dispensed in certain pharmacies that meet all the safety requirements. Such pharmacies would most likely hospital- or clinic-based but some community pharmacies would be eligible if they met those criteria. That may also require various payors to ensure that such special pharmacies are included in their networks. Since the criteria should include not only ability to perform double checks but also have full access to relevant clinical information, knowledge about the various chemotherapy regimens, and ability to sit down with the patient to thoroughly go over the instructions, we doubt that mail order pharmacies would meet the criteria.
Secondly, recognizing that complex regimens and cycles are the most vulnerable to errors involving wrong number of day supplies, we need to look at how we prescribe. We are always balancing patient convenience against patient safety. In several of our previous columns on home infusion chemotherapy we noted no one seemed to be asking “what is the highest dose that a patient could tolerate in one day (or less) if there was inadvertent administration of the infusion?”. A safety culture would design the protocol with sublethal dosages that would protect the patient in the event of “what can go wrong will go wrong”. It also would not put the healthcare workers at the “sharp end” in a situation none of us would want to be in. The same question should apply to oral chemotherapy regimens and be “What would be the highest aggregate dose a patient could tolerate over a specified period?” and avoid prescribing more than that inadvertently. Yes, the patient might be inconvenienced by having to do another physician or clinic visit to get a prescription for the next cycle or the second part of a complex regimen. But isn’t that preferable to receiving a chemotherapy overdose due to an avoidable error?
Our prior columns related to chemotherapy safety:
Griffin MC, Gilbert RE, Broadfield LH, et al. Comparison of Independent Error Checks for Oral Versus Intravenous Chemotherapy. Journal of Oncology Practice 2015;
Published online before print September 29, 2015
Weingart SN, Flug J, Brouillard D, et al. Oral chemotherapy safety practices at US cancer centres: questionnaire survey. BMJ 2007; 334: 407
ISMP Canada. Analysis of Incidents Involving Oral Chemotherapy Agents. ISMP Canada Safety Bulletin 2015; 15(4): 1-4, April 22, 2015
Weingart SN, Toro J, Spencer J, et al. Medication errors involving oral chemotherapy. Cancer 2010; 116(10): 2455-2464
April 26, 2016
Lots More on Preventing Readmissions But Where’s the Beef?
Busy month for articles on preventing readmissions! Two on tools for predicting readmission and more on programs looking to prevent readmissions.
The HOSPITAL score is a readmission prediction score originally derived and internally validated on medical patients at the Partners HealthCare Network in Boston in 2013 (Donzé 2013). It is based on 7 independent factors:
H hemoglobin at discharge
O discharge from an Oncology service
S sodium level at discharge
P procedure during the index admission
IT index type of admission (urgrent)
A number of admissions during the last 12 months
L length of stay
Donzé and colleagues now have validated the HOSPITAL score in an international multicenter study that demonstrated the score could identify patients at high risk of 30-day potentially avoidable readmission with moderately high discrimination and excellent calibration in medical patients (Donzé 2016).
Another study (Siracuse 2016) showed that risk-stratification models, such as the Readmission After Total Hip Replacement Risk (RATHRR) Scale, can identify high-risk patients for readmission and permit implementation of patient-specific readmission-reduction strategies to reduce readmissions and health care expenditures. The variables (from total hip replacement patients in a large administrative database) found to be associated with increased risk of readmission after total hip replacement were: being older than 71 years, African American, in the lowest income quartile, revision replacement, liver disease, congestive heart failure, chronic pulmonary disease, renal failure, diabetes, fluid and electrolyte disorder, anemia, rheumatoid arthritis, coagulopathy, hypertension, and obesity. These were used to create the RATHRR Scale, which was applied to the validation cohort and explained 89.1% of readmission variability in that cohort. The authors suggest that the RATHRR Scale could be used preoperatively to identify patients at greatest risk for readmission and pay special attention to their needs before and after discharge.
The RATHRR score weighs comorbidities heavily. Another recent study (Havens 2015), looking at readmissions following emergency general surgery, also found that a Charlson Comorbidity Index score of 2 or greater was a predictor of readmission, along with public insurance and leaving against medical advice.
Both the HOSPITAL and RATHRR scores do identify patients at highest risk for readmission. However, we’re not sure they are really of much use in implementing care plans to reduce the risk of readmission. We’ve had this discussion before in our many columns on fall prevention. Fall risk “scores” are not of much benefit if they just identify patients at highest risk without directing focus to those factors that are most amenable to interventions.
So what are those factors that might be amenable to intervention and prevent readmissions? Auerbach and colleagues (Auerbach 2016) reviewed in detail 1000 cases where general medicine patients (average age 55 years) were readmitted to academic hospital within 30 days of discharge and found that about one-quarter (26.9%) of readmissions were potentially preventable. Perspectives of patients, physicians and intense case review were used. Some factors identified but that did not prove to be independent variables were failure to adequately treat symptoms, failure to monitor for medication adverse effects or noncompliance, failure to schedule timely followup visits, and need for additional or different home services. Of factors independently associated with preventable readmissions, premature discharge was a factor in some cases but other factors were equally or more important. Such included inability of patients to keep followup appointments, patient lack of awareness of whom to contact after discharge, failure to relay important information to outpatient healthcare professionals, and lack of adequate discussion about care goals for patients with serious illnesses. But another big factor identified was decision making by the emergency department (admitting patients that others felt did not need admission), though we concur with the accompanying editorial (Atkins 2016) that hindsight bias may be influencing that perception. The authors also note some factors that were somewhat surprisingly not found to be contributing factors. These included patient functional status and patient reports of and satisfaction with care. Significantly, in about half the admissions deemed preventable, gaps in care during the index admission were felt to have been present.
And what is the impact of interventions designed to prevent avoidable readmissions? Another new study reported results of a multicomponent intervention in which Yale-New Haven Hospital and an affiliated community hospital partnered with community resources in attempt to prevent readmissions (Jenq 2016). This was part of a special Medicare program to promote programs aimed at preventing readmissions. The teams screened inpatients, using a tool from the BOOST project (see our May 10, 2011 Patient Safety Tip of the Week “Preventing Preventable Readmissions: Not As Easy As It Sounds”) to identify patients at high risk for readmission. The intervention consisted of patient/family education, use of community care “consultants”, followup phone calls aimed at making sure patients were engaged in their care, medication management, compliance with discharge instructions, and home visits if necessary. There was also coordination between the care “consultants” and staff if the patient had been discharged to an SNF or long-term care facility.
The adjusted readmission rate for the target group decreased from 21.5% to 19.5% (that for the control population went from 21.1% to 21.0% during the same period). The relative risk reduction was 9.3%, a modest reduction at best and less than the target Medicare had set. In fact, the number needed to treat (NNT) to avoid one readmission was 50, a substantial number. Figuring in the costs of the program, the authors calculated it took $7000 of resources to prevent one readmission. The authors do note, however, that the average cost to Medicare for readmission is about $12,000 so there may still be some incentive for Medicare to support such intervention programs. We note that does not take into account the additional services and costs on the outpatient side so any potential savings to Medicare is even smaller.
The study, one of the few done on sizeable populations, illustrates the challenges and somewhat frustrating results seen in this endeavor.
Almost all the studies done on preventing readmissions focus on fiscal issues. Not surprising since hospitals may now penalized by CMS and other payors for readmissions. But lost in all of this is what happens to the patient in terms of outcomes, patient safety, mortality, and quality of life. Almost no studies on readmissions deal with those issues. We concur with the editorialists (Atkins 2016) that perhaps the most important lesson from the Auerbach study is that it highlights the fragmented healthcare system and gaps in communication and continuity of care. We can’t tell you how often we see instances where primary care physicians (PCP’s) are never even informed that their patient was in the ER or hospitalized. Or instances where patients show up in the PCP office after discharge and no records of the hospitalization or ER visit are accessible. Or, worse yet, results of pending tests done during the hospitalization are never received and acted upon by anyone. We’ve even seen instances where on admission to the hospital the patient’s PCP’s name gets replaced in an EMR field with the name of a hospital-based physician and any information that might get routed to a PCP now gets routed elsewhere. And while the ER took some blame in the Auerbach study, there are likely reasons the ER was put in the position of making those decisions to admit. Often the patient went to the ER because the physician cross covering for the PCP (or other physician) did not know the patient and took the easy route, telling the patient “Go to the ER”. Particularly in academic settings such as those in the Auerbach study it is common for patient calls after hours to be taken by residents who do not know the patient and also take the “go to the ER” route.
So, yes, readmissions deserve attention but for the right reasons. We always recommend that whenever a patient is readmitted (or has an unplanned admission) a mini-RCA (root cause analysis) should be done. While the PCP should usually be the one to initiate that process, he/she may meet the same barriers that caused the problem in the first place. So if you are part of a larger organization or an ACO there should be one or more individuals who should do the legwork and oversee a thorough investigation of the root causes.
Donzé J, Aujesky D, Williams D, Schnipper JL. Potentially avoidable 30-day hospital readmissions in medical patients: derivation and validation of a prediction model. JAMA Intern Med 2013; 173(8): 632-638
Donzé JD, Williams MV, Robinson EJ, et al. International Validity of the HOSPITAL Score to Predict 30-Day Potentially Avoidable Hospital Readmissions. JAMA Intern Med 2016; 176(4): 496-502
Siracuse BL, Chamberlain RS. A Preoperative Scale for Determining Surgical Readmission Risk after Total Hip Replacement. JAMA Surg 2016; Published online March 09, 2016
Havens JM, Olufajo OA, Cooper ZR, et al. Defining Rates and Risk Factors for Readmissions Following Emergency General Surgery. JAMA Surg 2015; :1-7 Published online first November 11, 2015
Auerbach AD, Kripalani S, Vasilevskis EE, et al. Preventability and Causes of Readmissions in a National Cohort of General Medicine Patients. JAMA Intern Med 2016; 176(4): 484-493
Atkins D, Kansagara D. Reducing Readmissions—Destination or Journey? JAMA Intern Med 2016; 176(4): 493-495
Jenq GY, Doyle MM, Belton BM, et al. Quasi-Experimental Evaluation of the Effectiveness of a Large-Scale Readmission Reduction Program. JAMA Intern Med 2016; Published online April 11, 2016
May 3, 2016
Clinical Decision Support Malfunction
We are big fans of clinical decision support systems (CDSS) as patient safety tools, keeping in mind that too much CDSS may lead to alert fatigue and unintended consequences. But well-reasoned clinical decision support rules that are also adequately tested for both validity and usability may be very effective tools.
Brigham and Women’s Hospital (BWH) in Boston probably has the most robust CDSS of any healthcare organization anywhere and they just reported some disturbing findings on malfunctions of CDSS alerts (Wright 2016). Serendipitously, the lead author had noted one such alert malfunction while he was demonstrating the CDSS. It happened to be an alert that would remind physicians to check the TSH level in patients who had been on amiodarone for at least a year. The research team subsequently identified three other examples of CDSS alert malfunctions and conducted a sample survey of CMIO’s at various hospitals and found most of them had also experienced CDSS malfunctions.
Alarmingly, they found that the alert malfunctions were often very difficult to detect and some had eluded detection for long periods of time (weeks or even years!). Moreover, the causes for the malfunctions were sometimes even more difficult to elucidate. They were, however, able to identify several contributing factors:
Changes to some of the data codes or data fields are often made by IT staff or external vendors who are not part of the CDSS team and such changes may not be apparent to the CDSS team members. For example, in the TSH/amiodarone example, a change had been made to the drug code for amiodarone.
Alert malfunctions were most often first identified by end-users. But those most often occurred when suddenly there was a spike in the frequency of alerts for one or many alerts. Alerts that failed to fire after malfunction were far more likely to elude detection.
The authors have several important recommendations:
The BWH researchers have identified a significant vulnerability in our CDSS operations, one that has important patient safety implications. This is a study that every healthcare organization needs to pay careful attention to and evaluate their own actual or potential vulnerabilities.
And, of course, most of you by now have seen the results of The Leapfrog Group’s most recent report on how hospitals perform on their CPOE evaluation tool (Leapfrog 2016). We’ve written about the Leapfrog tool in several prior columns (see our previous columns for July 27, 2010 “EMR’s Still Have a Long Way to Go” and June 2012 “Leapfrog CPOE Simulation: Improvement But Still Shortfalls” and March 2015 “CPOE Fails to Catch Prescribing Errors”).
To fully meet Leapfrog’s standard, hospitals must:
In 2015 nearly two-thirds of hospitals (64%) fully met the standard, showing a considerable improvement compared to 14% in 2010. The hospitals also demonstrated improved performance in medication reconciliation. However, on the 2015 Leapfrog Hospital Survey, hospitals’ CPOE systems failed to flag 39% of all potentially harmful drug orders, or nearly two out of every five orders. The systems also missed 13% of potentially fatal orders.
The Wright study and the Leapfrog study demonstrate that it is never enough to simply implement a CPOE system or e-prescribing system with clinical decision support systems and assume your patients will be safe from medication errors. Clearly, ongoing evaluation and assessment using validated tools are important to identify vulnerabilities that may be unexpected. We, of course, should expect better design and function from our IT vendors. However, the Wright study clearly shows that problems may arise even when the initial design and implementation were good yet changes to systems or files result in gaps that may go unidentified for long periods.
See some of our other Patient Safety Tip of the Week columns dealing with unintended consequences of technology and other healthcare IT issues:
Wright A, Hickman T-T T, McEvoy D, et al. Analysis of clinical decision support system malfunctions: a case series and survey. JAMIA 2016; First published online: 28 March 2016
The Leapfrog Group. Hospitals’ Computerized Systems Proven to Prevent Medication Errors, but More is Needed to Protect Patients from Harm or Death. The Leapfrog Group 2016; April 7, 2016
May 10, 2016
Medical Problems in Behavioral Health
Behavioral health units, whether they are stand alone facilities or part of general hospitals, are prone to many adverse events due to medical rather than psychiatric conditions. There are a variety of factors predisposing to such events and barriers to preventing them.
What should be done during “medical clearance” in the emergency room prior to admission to behavioral health units has long been debated. Most now agree that the medical history and physical should direct the need for laboratory or imaging studies and that there really is no standard battery of tests that should be done. Most testing is unnecessary and wasteful and delays admission to behavioral health. Traditionally, the main goal of the “medical clearance” is to be sure that the patient’s behavioral health presentation is not the result of an underlying medical condition. But equally important should be identification of medical problems that are likely to complicate management during a behavioral health admission.
As above, “routine” lab testing is seldom of value as part of the medical clearance. Even drug toxicology screening is of limited benefit. Such drug screening is more likely to identify recent use of drugs rather than identify drugs contributing to the current behavioral health condition. However, we’d like to highlight one problem that may be becoming more troubling. The ever increasing use of long-acting and/or delayed release formulations of opioids raises specific concerns. We’ve seen patients who have taken such drugs and been alert in the ER with low levels of drug in their urine screen yet become obtunded due to opioid intoxication the following day due to the delayed absorption of these drugs.
Falls are probably one of the more frequent adverse events on behavioral health units. In our Patient Safety Tips of the Week for January 15, 2013 “Falls on Inpatient Psychiatry” we noted that falls are disproportionately more frequent on behavioral health units compared to med-surg units. In that column and in our December 3, 2013 Patient Safety Tip of the Week “Reducing Harm from Falls on Inpatient Psychiatry” we noted also that injuries from falls are also more likely with falls on psychiatric/behavioral health units.
One reason for more falls is likely that patients are more active on behavioral health units. But the other big reason is related to the medications used in behavioral health. Most importantly, they are on a variety of medications that may increase the fall risk (antipsychotics, antidepressants, sedative/hypnotics, and others). Some may be confused or agitated. Others may have impaired gait or balance, sometimes as a result of extrapyramidal side effects of their medications. Many of the medications cause orthostatic hypotension. The elderly patient on the behavioral health unit is especially at risk for falls with injury. Another factor is that sometimes behavioral health units restrict use of canes or other devices that could assist ambulation because such might also be used as weapons.
Because more traditionally used fall risk assessment tools have not been particularly applicable to psychiatric inpatients, Edmonson and colleagues (Edmonson 2011) have developed their own fall risk assessment tool for psychiatric inpatients. They identified 9 categories of fall risk factors from the literature, then determined how frequent those occurred in records of psychiatric inpatients who fell, resulting in a weighted tool for predicting falls in this population. They then administered this tool, the Edmonson Psychiatric Fall Risk Assessment Tool (EPFRAT), and a more traditional fall risk assessment tool (the Morse Fall Scale) simultaneously to an inpatient psychiatric population and found the EPFRAT had a higher sensitivity in predicting falls and comparable specificity.
Just like on med-surg units, fall risk is a dynamic risk and may change during the course of a behavioral health stay. For example, extrapyramidal side effects may gradually evolve after certain drugs have been started so patients should be examined daily to identify the occurrence of extrapyramidal side effects and the fall prevention strategies modified appropriately as they occur.
We refer you back to that Patient Safety Tips of the Week for January 15, 2013 “Falls on Inpatient Psychiatry” for a whole host of recommendations we have regarding prevention of falls on behavioral health units.
Seizures are not uncommon on behavioral health units. Many of the drugs used may lower the seizure threshold, particularly in patients with a previous history of seizures. Withdrawal syndromes are a major concern, too (keeping in mind that substance abuse a common comorbidity in behavioral health patients) and seizures may be part of those syndromes. While seizures from alcohol withdrawal typically occur early after abstinence, withdrawal from cessation of drugs like benzodiazepines typically occur much later. And in patients with pre-existing seizure disorders who have been on anticonvulsant therapy it is important to recognize they may have been poorly adherent to their regimen. You should check their serum anticonvulsant levels (if they are on anticonvulsants that have therapeutic ranges) and make dosage adjustments as appropriate.
Most importantly, staff need to be trained in what to do when a seizure does occur. That includes ensuring the patient does not injure him/herself during the seizure and knowing how to get help in determining the cause of the seizure and any subsequent management steps. They also need to consider how other patients on the unit might react to seeing a seizure (and especially prevent those patients from inadvertently injuring a patient in attempt to help).
Cardiovascular events may also occur on behavioral health units. We noted orthostatic hypotension as a cause for falls. Orthostatic hypotension may also cause syncopal episodes. A whole host of drugs used in behavioral health, particularly certain antidepressants and antipsychotic drugs, may cause orthostatic hypotension. We won’t repeat our usual harangue about how to properly assess for orthostatic hypotension but if you really want to know go back to our Patient Safety Tip of the Week for January 15, 2013 “Falls on Inpatient Psychiatry”.
Torsade de Pointes is a form of ventricular tachycardia, often fatal, in which the QRS complexes become “twisted” (changing in amplitude and morphology) and is best known for its occurrence in patients with long QT intervals. In our June 29, 2010 Patient Safety Tip of the Week “Torsade de Pointes: Are Your Patients At Risk?” we discussed the risks of this potentially fatal syndrome in hospitalized patients. Though cases of the long QT interval syndrome (LQTS) may be congenital, many are acquired and due to a variety of drugs that we prescribe. And many of those drugs may be used in behavioral health settings. Perhaps the best known are haloperidol and methadone but a variety of antipsychotic drugs and antidepressants may prolong the QT interval (see our February 5, 2013 Patient Safety Tip of the Week “Antidepressants and QT Interval Prolongation”). For a full list of drugs that commonly cause prolongation of the QT interval and may lead to Torsade de Pointes, go to the CredibleMeds™ website. So if one of these drugs will be prescribed for a behavioral health patient they should have a baseline electrocardiogram and then a followup one to see if the QT interval has been prolonged to dangerous levels.
Deep venous thrombosis (DVT) is relatively rare on behavioral health units. Yet every year state incident reporting systems receive reports of DVT or even fatal pulmonary embolism in patients on behavioral health units. This most often occurs in patients with severe behavioral health problems that leave them bedridden. We’ve seen DVT in one patient who had laid in bed at home several weeks prior to admission. Therefore, it is essential that every patient admitted to behavioral health units received an assessment for DVT risk factors just as if they had been admitted to a med/surg unit.
A major category of medications typically used on inpatient psychiatric units are antipsychotic drugs that may have extrapyramidal side effects. These may affect gait, balance, and reaction times to increase the risk of falls. When these drugs are started the patient should be examined daily to identify the occurrence of extrapyramidal side effects and the fall prevention strategies modified appropriately as they occur.
Anticholinergic Side Effects
Many of the drugs used in behavioral health have anticholinergic side effects. Dry mouth is the most common symptom but dry eyes, mydriasis, constipation, and others may occur. Probably the most significant anticholinergic effect would be urinary retention.
Simple eye care is often overlooked on behavioral health inpatients. One study (Aye 2015) examined eye care in 54 involuntarily-held psychiatric patients in a county hospital. Their average length of stay was 12 days. 63% claimed to wear either glasses or contact lenses. One patient who wore contact lenses developed eye irritation that necessitated use of antibiotic eye drops. Another contact lens wearer removed her contact lenses because of irritation and lack of contact lens solution and went 16 days with impaired vision. Only a third of patients who wore glasses had them with them during the hospitalization. The authors also note that impaired vision may contribute to or exacerbate psychosis. They note that emergency physicians and inpatient psychiatrists seldom ask even the most basic questions about vision and eye care. To that we’ll add that many of the medications used on behavioral health units also have prominent anticholinergic side effects, potentially worsening drying of the eyes and further predisposing to irritation from contact lenses.
Oral Health/Dental Hygiene
Oral health and dental hygiene are often problematic in patients with behavioral health issues (DeHert 2011). DeHert and colleagues noted the following factors which influence oral health: type, severity, and stage of mental illness; mood, motivation and self-esteem; lack of perception of oral health problems; habits, lifestyle (e.g., smoking), and ability to sustain self-care and dental attendance; socio-economic factors; effects of medication (dry mouth, carbohydrate craving); and attitudes and knowledge of dental health teams concerning mental health problems. They conclude that facilitating access to dental care and addressing modifiable factors such as smoking and medication side effects are extremely important in this population.
Weight gain, metabolic syndrome, glucose intolerance and frank diabetes mellitus may be seen as side effects of several medications used in behavioral health, most notably the atypical antipsychotics. These are more of a concern in the long-term management of behavioral health patients rather than acute problems seen during a hospitalization. Nevertheless, recognition of these side effects and ensuring appropriate followup is important.
Medical emergencies like the neuroleptic malignant syndrome and serotonin syndrome are rare but potentially life-threatening and need prompt recognition and treatment. Neuroleptic malignant syndrome (NMS) is characterized by fever, muscular rigidity, altered mental status, and autonomic dysfunction. NMS usually occurs shortly after the initiation of neuroleptic treatment (4-14 days) or after dose increases. Serum CPK is often elevated and rhabdomyolysis and myoglobinuria may be present. It may progress to renal failure, respiratory failure and death. In addition to cessation of the offending neuroleptic agent, treatment is mostly supportive. Several drugs have been tried as treatments but evidence for their effectiveness is limited (Tse 2015).
The serotonin syndrome is another potentially life-threatening condition with some similarities to the neuroleptic malignant syndrome. It also may have signs of autonomic instability (tachycardia, hypertension, dilated pupils, diaphoresis, piloerection), fever, and muscle rigidity. Other muscular phenomena are twitching, myoclonus, clonus, hyperreflexia, shivering, and loss of coordination. Seizures, unconsciousness and arrhythmia occur in severe cases. It is associated with serotoninergic medications, such as selective serotonin reuptake inhibitors (SSRIs), and usually evolves more rapidly than NMS. Diagnosis is clinical and lab tests are not diagnostic. Treatment consists of cessation of the offending agent(s) and supportive care. Benzodiazepines are often used for sedation. Symptoms and signs usually disappear within a day of cessation of the offending agent(s) though they may last longer if the half-life of the offending agent is longer. Those cases associated with monoamine oxidase inhibitors tend to be more severe. Drugs that have serotonin antagonism (eg. cyproheptadine) have been used in some cases but evidence of efficacy is limited.
Barriers/Challenges/Models of Care
Barriers to care of comorbid medical conditions are common on behavioral health units (Frost 2006). Psychiatrists often do not do medically-oriented history and physicals on their patients because it might interfere with the therapeutic relationship. In some facilities, a different psychiatrist might do that portion of the H&P. But let’s be frank – most psychiatrists have a limited ability to deal with comorbid medical problems in their patients. Therefore, behavioral health units typically have a medical person (often a nurse practitioner) attend to the comorbid medical conditions on their patients. But all the healthcare workers on behavioral health units may be uncomfortable with the medical conditions. Nurses may have not worked on med/surg units for many years. Many behavioral health units lack rooms or equipment that are needed for medical evaluation. Such equipment and supplies (eg. supplies a surgeon or other physician might need to perform simple wound care) may have to be kept locked securely on behavioral health units. And we often see consultants who are uncomfortable or even fearful when dealing with behavioral health patients.
Getting an adequate medical history may also be more difficult because of limited patient cooperation and difficulty reaching family or others who might be secondary sources of medical information. Behavioral health patients are also more likely to be non-adherent to medication regimens and non-compliant with other medical interventions. In addition, they often have not had the preventive health services that would have been recommended.
Frost (Frost 2006) also points out that some free-standing behavioral health units may have limited lab, radiology, and pharmacy resources available for handling the medical problems in behavioral health patients.
There are several potential models of care for handling medical problems on behavioral health units:
Many behavioral health units, particularly those at smaller hospitals, utilize nurse practitioners who work in conjunction with an internist or hospitalist. The nurse practitioner is embedded on the behavioral health unit and addresses all the medical issues. They perform the history and physical on the patient and enter the non-behavioral health orders. Over time the nurse practitioner develops a good feeling for the nuances of medical issues in the behavioral health patient and this model does provide continuity. Larger hospitals may use a dedicated internist in the same fashion.
A 2012 article in Today’s Hospitalist (Darves 2012) discussed models in which medical hospitalists collaborated with psychiatrists in managing patients on behavioral health units. It noted some that successfully reduced large numbers of inappropriate studies ordered on such units. But it also noted the many challenges for the hospitalists. They had to be aware of the potential drug-drug interactions or contraindications of drugs they might encounter with patients on certain psychotropic medications, especially MAO inhibitors. This may necessitate order sets that are different from those used elsewhere in the hospital. Hospitalists also had to learn to deal with patients who were under watch for suicide or elopement, or housed in locked locations and rounding hospitalists may need a psych nurse as chaperone when encountering psychiatric patients. So close coordination with nursing staff was needed to determine when precautions were in order. One problem we have seen with the hospitalist model is that most hospitalists tend to work in blocks (for example, 5 days on then 5 days off or some other similar scheduling format). Particularly since the length of stay on behavioral health units is longer than that on med-surg units, that may lead to issues with continuity of care.
Both the nurse practitioner model and the hospitalist models do require some coordination. While the nurse practitioner or hospitalist needs to participate in the multidisciplinary team discussions on each patient many recognize it may not be good use of their time or the time of the behavioral health workers to be present for the entire session. So typically the behavioral health staff and the medical staff will allocate portions of the team meetings to be most efficient.
The consultant model works best for certain conditions. Diabetes care, in particular, is often less than optimal on behavioral health units. Behavioral health patients often cannot readily identify the insulin regimens they were on at home and access to family or caregivers at home may be limited. One study of psychiatric inpatients in the UK (Kan 2016) found that patients with severe mental illness and diabetes are not receiving standard care in glucose monitoring or appropriate access to specialist diabetes services when admitted to a psychiatric unit. Hyperglycemia events are poorly managed, suggesting an urgent need to raise awareness of diabetes management among clinical teams. They also found that capacity to consent for diabetes treatment needs to be addressed. Care is also complicated in that the patients may be poorly compliant with their medications and diet. We recommend that any diabetic patient who is taking insulin be followed by a medical consultant while they are inpatients on a behavioral health unit.
Another condition where the consultant model may be needed is pregnancy. Pregnancy and behavioral health hospitalization raises both challenges and opportunities. An older study (Miller 1990) found in a group of pregnant psychiatric patients admitted to a psychiatric service a high rate of involuntary admission, homelessness, and substance abuse, and identified many risk factors associated with noncompliance with ongoing prenatal care. They concluded that brief psychiatric hospitalization can be an important aspect in improving obstetric outcome by providing an opportunity to collect obstetric information and promote ongoing prenatal care.
In 2009 the American Psychiatric Association (APA) and the American College of Obstetricians and Gynecologists (ACOG) issued a joint report on the management of depression during pregnancy (Yonkers 2009). It addresses numerous issues related to depression and pregnancy and notes that research is hampered by:
Close collaboration between ob/gyn physicians and behavioral health staff is obviously important in trying to get optimal outcomes in both mothers and infants.
Med/psych units are another option. These are primarily medical units that are staffed with physicians and nurses well trained in dealing with behavioral health patients. Here the psychiatrist would be embedded in a fashion similar to how the medical physician was embedded in the behavioral health units above. In effect the patient has co-attendings: a psychiatrist and an internist. Unfortunately, this unit is usually substantially more expensive to operate and the staffing and expertise are usually available only in larger general hospitals or teaching hospitals.
An offshoot of the med/psych unit is the geriatric psychiatry unit. Geriatric patients, because of their likely greater prevalence of comorbid medical conditions, are particularly at risk on behavioral health units. Therefore, specialized geriatric psychiatry units that are co-staffed by psychiatrists and geriatricians and nurses with a strong background in handling medical problems are recommended for such patients.
Some medical conditions are more serious and demand that the patient be cared for on a med-surg floor or an ICU. Also, patients taking drug overdoses typically are admitted first to a medical service and then transferred to the behavioral health unit once medically improved and stable. But such patients on med-surg units or ICU’s may present special problems. Windows in such units are typically not designed to be “jump” proof and behavioral health patients may jump from the windows (see our April 12, 2016 Patient Safety Tip of the Week “Falls from Hospital Windows”). Similarly, med-surg units and ICU’s are not designed for suicide prevention and patients there have easy access to “loopable” items and other items that can be used for suicide. Therefore, “sitters” are typically needed to provide 1:1 observation and supervision of behavioral health patients on these medical units. Unfortunately, such “sitters” often receive inadequate training in dealing with the behavioral health patient. Moreover, “sitting” is a boring task and we’ve seen patients harm themselves even in the presence of “sitters”.
We also need to be cognizant that the hospital may be only source of attention to medical care that many of these patients will be exposed to. We know how difficult it often is just arranging for post-discharge behavioral health care in these patients. It is equally difficult ensuring they get adequate followup for their medical problems.
Edmonson D, Robinson S, Hughes L. Development of the Edmonson Psychiatric Fall Risk Assessment Tool. J Psychosoc Nurs Ment Health Serv. 2011; 49(2): 29-36
Edmonson D/Memorial Medical Center (Springfield, IL). Edmonson Psychiatric Fall Risk Assessment Tool ©. (Download page – requires copyright agreement).
Aye JB, Woo BKP. Improper eye care during inpatient psychiatric stay. General Hospital Psychiatry 2015; 37(1): e5-e6
DeHert M, Correll CU, Bobes J, et al. Physical illness in patients with severe mental disorders. I. Prevalence, impact of medications and disparities in health care. World Psychiatry 2011; 10(1) Feb 2011
Tse L, Barr AM, Scarapicchia V, Vila-Rodriguez F. Neuroleptic Malignant Syndrome: A Review from a Clinically Oriented Perspective. Curr Neuropharmacol 2015; 13 (3): 395-406
Frost M. The Medical Care of Psychiatric Inpatients: Suggestions for Improvement. The Internet Journal of Healthcare Administration 2006; 4(2)
Darves B. The rewards and challenges of treating psychiatric patients. Why you need a different approach when working a psych unit. Today’s Hospitalist 2012. June 2012
Kan C, Kaar SJ, M. Eisa M, et al. Diabetes management in psychiatric inpatients: time to change? Diabetes Medicine 2016; 33(3): 407-408; Article first published online: 11 FEB 2016
Miller WH, Resnick MP, Williams MH, Bloom JD. The pregnant psychiatric inpatient: a missed opportunity. Gen Hosp Psychiatry 1990 ; 12(6): 373-378
Yonkers KA, Wisner KL, Stewart DE, et al. The management of depression during pregnancy: a report from the American Psychiatric Association and the American College of Obstetricians and Gynecologists. Gen Hosp Psychiatry. 2009; 31(5): 403-413
May 17, 2016
Patient Safety Issues in Cataract Surgery
Just as a push to perform cataract surgery in the office setting has appeared, a study from Massachusetts has revealed preventable patient safety errors continue to occur in cataract surgery. Don’t get us wrong – cataract surgery is one of the safest procedures of all and the rates of adverse events are very small indeed. But the Massachusetts experience would certainly would suggest the need to have the same degree of oversight and reporting of adverse events in office practice that we have in hospitals and ambulatory surgery centers (ASC’s).
The Betsy Lehman Center for Patient Safety and Medical Error Reduction just published its analysis of adverse events occurring during cataract surgery in Massachusetts between 2011 and 2015 (Betsy Lehman Center 2016). The study was done in conjunction with the Massachusetts Department of Public Health, the Massachusetts Society of Eye Physicians and Surgeons, the Massachusetts Society of Anesthesiologists, and the Massachusetts Board of Registration in Medicine. Representatives from various hospital and patient safety organizations also served either on the steering committee or as reviewers.
While the numbers of adverse events were small (28 serious events over the 5 year period), the continued occurrence of wrong lens, wrong patient, and wrong eye procedures is bothersome. In addition, loss of vision from nerve blocks was also noted.
Implantation of the Wrong Intraocular Lens (IOL)
Implantation of the wrong intraocular lens (IOL) represented over half the cases in the Betsy Lehman Center report and occurred 15 times in the 5 year period. That is a problem near and dear to our heart. Twenty years ago we reviewed a scenario where two consecutive patients received implantation of incorrect intraocular lenses after another patient had been inserted into the surgical schedule because he complained he had been told he’d be the first case of the day. After our review of the cases and identification of numerous factors that contributed we commented “I can’t believe this has never occurred before”, only to be confronted with sheepish grins indicating this had not been the first time such had occurred. Shortly thereafter we were at a meeting of the clinical committee advising the New York State Department of Health on its incident reporting system. During the lunch break, we asked if any of the other hospitals represented had experienced similar incidents. The hands of at least a third of the hospital representatives went up! As a result of those cases, we developed one of the very first comprehensive “timeout” polices in the US, one that later served as a model for similar policies across New York and the country (see our Patient Safety Tip of the Week “Weighing in on Double-Booked Surgery”).
John Simon and his colleagues at Albany Medical College subsequently published an analysis of New York state cases as part of their retrospective review of 106 cases of surgical “confusions” in several venues (Simon 2007a, Simon 2007b, Simon 2007c). These include 42 cases from the Ophthalmic Mutual Insurance Co. and 64 cases from the New York Patient Occurrence and Reporting Tracking System (NYPORTS). 67 cases involved wrong lens implants, 15 cases wrong-eye operations, 14 cases wrong-eye block, 8 wrong patient or procedure, and 2 wrong corneal transplant. Based on these findings, they estimated an incidence of 6.9 such errors per 100,000 ophthalmologic surgeries.
Implantation of the wrong intraocular lens was the most common occurrence in both databases. Errors in both the preoperative period and operative period were found to lead to the incorrect implantation. In the preoperative period, contributory causes identified included faulty calibration of the A-scan equipment, transposition of records from the ophthalmologist’s office, transcription errors, switched patient identification stickers, and transposition of IOL power calculations while faxing records on two patients at the same time.
Intraoperative errors in almost all cases involved failure to identify the lens specifications properly before implantation. Multiple contributory factors were identified, including changes in the OR schedule, changed staff assignments, staff changes during the procedure, poor lighting, multitasking and other distractions, and misreading the label on the implant box. In one case the surgeon had dropped multiple patient charts and they were out of order when reassembled.
Fortunately, analysis of the cases of implantation of the wrong IOL by Simon’s group and other studies (Kelly 2011) (Rongé 2006) have helped identify many of the factors contributing to these events so that preventive measures are now recognized.
The Betsy Lehman Center report cites that many of the reported events stemmed from:
They also identified the following key factors contributing to incorrect IOL implantation:
We like to emphasize the problem created by late changes in the surgical schedule. In our original case 20 years ago a patient complained that his surgeon had told him he was going to be the first case of the morning. So staff rearranged the schedule, inserting his case before several others on the schedule. The surgeon had several patient charts and multiple IOL’s arranged in order in the OR at the time, further complicating the situation. That led to our original “timeout” policy which set forth not only patient verification procedures but also banned the presence in the OR of either charts or IOL’s or imaging studies on more than one patient at a time. Almost every analysis of implantation of incorrect IOL’s also mentions change in the surgical schedule as a contributing factor in some cases. It’s a good practice now to let all parties know when a case is taken out of order (either an add-on case, a cancellation, or other change in the order of the scheduled surgical list). While Universal Protocol should always lead to verification of correct patient, procedure, laterality, etc. the “mental image” of the surgical schedule may still lead to parties mistaking patients or items even after a properly done timeout.
And they make the following key recommendations to prevent wrong lens, wrong eye, wrong patient errors:
The report stresses that the method for lens orders should be standardized. They note that handwritten orders for lenses are vulnerable to errors and instead recommend offices submit either typed requests for lenses or fill out formal forms, preferably electronic forms. Note that a study on wrong IOL implantations in the UK (Kelly 2011) also identified abbreviations as contributing to the problem. They warned that the dangerous abbreviations ‘D’ for diopter and ‘+’ for plus and ‘-’ for minus may result in confusion. The UK study also gave examples of handwritten transcription errors such as mixing up ‘11’ and ‘17’, ‘14’ and ‘19’, ‘10.5’ and ‘19.5’, ‘20’ and ‘2D’, etc. The Betsy Lehman Center study provided an example of a handwritten IOL order in which ‘+17.50’ and ‘+12.50” were confused. Bottom line: don’t accept handwritten IOL orders!
Biometry errors were also noted in the UK study (Kelly 2011). These included use of incorrect biometry formulas, misfiling biometry reports in the wrong patient record, mixing IOL powers for right and left eyes, and failure to remove contact lenses when doing biometric measurements. The UK authors recommend:
Another problem may arise when patients have the same or similar last names (Rongé 2006). While we would hope all facilities are religiously practicing 2-factor verification for all patients, we still recommend that the surgeon, anesthesiologist, and the OR staff review the surgical schedule for the day and identify in advance any instances where patients have the same or similar last names so that special precautions may be taken
Furthermore, the Betsy Lehman Center study suggests that lenses should be stored in a separate space outside the operating room. Only the lens or lenses for the current patient should be present in the OR. In cases we had seen in the past, an anachronistic practice in which ophthalmologists would get their IOL’s from vendors on consignment and literally bring a whole bag of IOL’s into the OR was a major factor in these adverse events. They also recommend designating a limited number of individuals who may retrieve the IOL’s from storage and place them with the patient chart. In addition, verification of the IOL should be done by several individuals (e.g., lens room staff, the nurse who retrieves the lens, and the surgeon) independently and as a team check to make sure that the lens is correct at multiple points such as when the lens is pulled from the storage closet, when the operating room is prepared for the patient, and immediately before lens enters the sterile field. It is important that several source documents be used during the verification process. These would include the patient chart, the original calculation sheet, the surgeon’s IOL order form, and the surgical print-out. From these sources the eye size, the lens model and lens power should be verified against the lens packaging. Like any other timeout or verification process, this is not a passive event. Rather each person should verbally verify the required information and anyone should be able to stop the case if there is any doubt or discrepancy identified. The process should also require documentation of the verification.
We’d also like to again stress the importance of having all source documents available before you start a case. In our June 5, 2007 Patient Safety Tip of the Week “Patient Safety in Ambulatoy Surgery” we lamented that the quality of the medical records is often not as good in ambulatory settings. The “facility” medical record is often scant and the physician often brings in his/her office notes that are “unofficial” as far as the facility is concerned. Often critical information is in the physician office record and never appears in the facility medical record. It is therefore incumbent upon the facility and entire team to ensure the adequacy of the medical record and all documentation prior to the procedure.
Ironically, one contributing factor identified in the UK study (Kelly 2011) was the use of white boards in the OR to list the power of the IOL. Sometimes IOL on the white board was not erased and updated when a new patient entered the OR. This was particularly a problem when the order of patients was changed.
And, of course, all the procedures, protocols, and checklists in the world will fail if all staff do not adhere to them. Failure to devote full attention of all staff during timeouts or other verifications, failure to use active rather than passive responses during such verifications, and cultures that do not allow any member of the OR team to stop a procedure are all problems we see over and over again in review of adverse events.
Time pressures are also a concern. Surgeons doing cataract surgery may have many cases scheduled in a single morning. Liz Kowaczyk, the Boston Globe’s excellent health correspondent writing on the Betsy Lehman report (Kowalczyk 2016), interviewed an anonymous nurse who described the surgeon coming in and saying “I have to be out of here by noon so let’s get going.” Bet none of your surgeons ever say that! Right!
Organizations should utilize some of the resources available for patient safety in both hospitals and the ambulatory surgery setting. The American Academy of Ophthalmology has issued good guidance statements on avoiding wrong-site surgery and avoiding incorrect intraocular lens placement (AAO 2011) with good examples of how checklists might be utilized, including The Wrong-Site Wrong-IOL Checklist in its Appendix 3. Also, in our June 8, 2010 Patient Safety Tip of the Week “Surgical Safety Checklist for Cataract Surgery” we discussed the UK National Patient Safety Agency (NPSA) Surgical Safety Checklist: for Cataract Surgery ONLY, based upon the WHO Surgical Safety Checklist.
The proliferation of so many new IOL options, such as multifocal and aspheric optics, has perhaps increased the odds of making mistakes (Rongé 2006). One of the discussants in that article, Dr. David Chang, called on lens manufacturers to help surgeons and ASC personnel avoid confusion by using different colors on their IOL boxes. The Betsy Lehman Center report also mentioned design of lens packaging (eg. similar labels and product codes, small print) as being problematic.
We refer you to that article from EyeNet (Rongé 2006) for descriptions of how several ambulatory centers have developed protocols for matching patients with the correct IOL’s.
And what do you do if you make a mistake like implantation of an incorrect IOL? We refer you to our columns on disclosure and apology listed below. Sometimes a patient would have required use of corrective lenses anyway after cataract surgery and they will simply require a different corrective prescription than they would have otherwise. But they still need to be told of the error(s) made, with an appropriate and sincere apology. Multiple studies have now validated the “disclosure and apology” approach as being not only the right thing to do but also reducing liability costs in the long run.
Wrong-Eye Anesthesia or Surgery
Surgery or anesthesia on the wrong eye was the second most common event in the Betsy Lehman Center report. Most events were anesthetizing the wrong eye, highlighting the importance of performing a separate timeout prior to nerve blocks. Key contributing factors apply to both anesthesia and surgery:
The importance of involving the patient in verification of the correct eye should be stressed. Again, an active rather than passive response from the patient should be sought (have the patient tell you which eye is to be operated on rather than asking “It’s this eye, isn’t it?”). But we’ll add our own caveat: given the demographics of the patient population undergoing cataract surgery there will be a substantial prevalence of cognitive dysfunction. We’ve all seen cases of wrong-site surgery where the patient indicated the wrong side. So it is critical that all source documents be consulted as part of the verification process either for the anesthesia or the surgery.
Surgical site marking is important and must be standardized across your facilities. Key features of such marking include that the mark should be unambiguous and should be “sufficiently permanent” to last through the procedure and be placed in an area that will still be visible after the patient is prepped and draped. There are examples where, for example, a “sticky colored dot” affixed to the skin over the eye intended for surgery becomes dislodged during the prep and draping.
Nerve Blocks Leading to Loss of Vision
The Betsy Lehman Center report included five cases of serious harm to patients, several of whom suffered permanent loss of vision, which occurred in a single day as a result of eye blocks administered by a contracted anesthesiologist during his second day at the facility and noted several reports elsewhere of other complications related to retrobulbar and peribulbar blocks.
The report recommends that:
Wrong Patient Surgery
Though there was only one reported case of wrong patient surgery in the Betsy Lehman Center report, the report has a discussion on ways to prevent wrong patient surgery. We refer you to our numerous columns on wrong-site, wrong-patient surgery listed at the end of today’s column.
The report goes on to detail recommendations for healthcare organizations and their leadership, ophthalmologists, surgeons, anesthesiologists, nurses and patients. It also emphasizes the important role that non-clinicians (eg. office staff) have in ensuring patient safety. The report is very well referenced and you’ll find it very valuable.
There are several other adverse events not included in the Betsy Lehman Center Report:
Methylene Blue Accidents
Another adverse event seen in cataract surgery is the inadvertent injection of methylene blue (dye) instead of trypan blue which results in catastrophic loss of vision (see our prior columns of May 20, 2014 “Ophthalmology: Blue Dye Mixup” and September 2014 “Another Blue Dye Eye Mixup”). That is a problem calling for a system fix as described in those columns.
Intraoperative Floppy Iris Syndrome (IFIS)
In our June 8, 2010 Patient Safety Tip of the Week “Surgical Safety Checklist for Cataract Surgery” we noted that the UK National Patient Safety Agency (NPSA) Surgical Safety Checklist: for Cataract Surgery ONLY, included a question about whether the patient was on tamsulosin or other alpha blocker. That is because of the risk of the “intraoperative floppy iris syndrome (IFIS)” and other complications (Bell et al 2009).
Moving Cataract Surgery to the Office?
In today’s introductory paragraph we noted the likely trend of moving cataract surgery away from hospitals and ambulatory surgery centers to the office setting. Such a trend is likely to follow after a recent study demonstrated the relative safety and effectiveness of such procedures done in the office setting (Ianchulev 2016). We expect that payors will also push for that trend since the overall costs will likely be lower. But few states have robust systems in place for reporting adverse events in the office setting. Given the findings in the Betsy Lehman Center report we would be very leery of such a move unless appropriate regulatory oversight and reporting is put in place for the office setting.
Cataract surgery in general is one of the safest surgeries undertaken today. Yet the Betsy Lehman Center report emphasizes that errors and adverse events still occur and that system interventions need to be implemented to minimize the risks even in this relatively safe surgery.
Some of our previous patient safety columns involving ophthalmology issues:
June 5, 2007 “Patient Safety in Ambulatoy Surgery”
March 11, 2008 “Lessons from Ophthalmology”
June 8, 2010 “Surgical Safety Checklist for Cataract Surgery”
June 2012 “Tailored Timeouts for Ophthalmologists”
May 20, 2014 “Ophthalmology: Blue Dye Mixup”
September 2014 “Another Blue Dye Eye Mixup”
Some of our prior columns related to wrong-site surgery:
September 23, 2008 “Checklists and Wrong Site Surgery”
June 5, 2007 “Patient Safety in Ambulatory Surgery”
July 2007 “Pennsylvania PSA: Preventing Wrong-Site Surgery”
March 11, 2008 “Lessons from Ophthalmology”
July 1, 2008 “WHO’s New Surgical Safety Checklist”
January 20, 2009 “The WHO Surgical Safety Checklist Delivers the Outcomes”
September 14, 2010 “Wrong-Site Craniotomy: Lessons Learned”
November 25, 2008 “Wrong-Site Neurosurgery”
January 19, 2010 “Timeouts and Safe Surgery”
June 8, 2010 “Surgical Safety Checklist for Cataract Surgery”
December 6, 2010 “More Tips to Prevent Wrong-Site Surgery”
June 6, 2011 “Timeouts Outside the OR”
August 2011 “New Wrong-Site Surgery Resources”
December 2011 “Novel Technique to Prevent Wrong Level Spine Surgery”
October 30, 2012 “Surgical Scheduling Errors”
January 1, 2013 “Don’t Throw Away Those View Boxes Yet”
January 2013 “How Frequent are Surgical Never Events?”
August 27, 2013 “Lessons on Wrong-Site Surgery”
September 10, 2013 “Informed Consent and Wrong-Site Surgery”
July 2014 “Wrong-Sided Thoracenteses”
Some of our prior columns on Disclosure & Apology:
July 24, 2007 “Serious Incident Response Checklist”
June 16, 2009 “Disclosing Errors That Affect Multiple Patients”
June 22, 2010 “Disclosure and Apology: How to Do It”
September 2010 “Followup to Our Disclosure and Apology Tip of the Week”
November 2010 “IHI: Respectful Management of Serious Clinical Adverse Events”
April 2012 “Error Disclosure by Surgeons”
June 2012 “Oregon Adverse Event Disclosure Guide”
December 17, 2013 “The Second Victim”
Other very valuable resources on disclosure and apology:
The Betsy Lehman Center for Patient Safety and Medical Error Reduction. Advancing Patient Safety in Cataract Surgery: A Betsy Lehman Center Expert Panel Report. May 2016
Simon JW. Preventing Surgical Confusions in Ophthalmology (presentation at NYSDOH Patient Safety Conference, Albany, NY, May 2007)
Simon JW. Preventing Surgical Confusions In Ophthalmology (An American Ophthalmolgical Society Thesis). Trans Am Ophthalmol Soc 2007; 105: 513-529
Simon JW, Ng Y, Khan S, Strogatz D. Surgical Confusions in Ophthalmology. Archives of Ophthalmology 2007; 125(11): 1515-1522
Kelly SP, Jalil A. Wrong intraocular lens implant; learning from reported patient safety incidents. Eye (Lond) 2011; 25: 730-734
Rongé LJ. Human Error During Cataract Surgery: Right Patient, Wrong Lens. EyeNet Magazine May 2006
Kowalczyk L. Report faults cataract surgery errors. Boston Globe 2016; May 12, 2016
American Academy of Ophthalmology Cataract and Anterior Segment Panel. Preferred Practice Plan Guidelines. Cataract in the Adult Eye. San Francisco, CA: American Academy of Ophthalmology; 2011
NHS NPSA. Surgical Safety Checklist: for Cataract Surgery ONLY (adapted from the WHO Surgical Safety Checklist)
Bell CM, Hatch WV, Fischer HD et al. Association Between Tamsulosin and Serious Ophthalmic Adverse Events in Older Men Following Cataract Surgery. JAMA 2009; 301(19): 1991-1996
Ianchulev T, Litoff D, Ellinger D, et al. Office-Based Cataract Surgery. Population Health Outcomes Study of More than 21 000 Cases in the United States. Ophthalmology 2016; 123(4): 723-728 April 2016
May 24, 2016
Texting Orders -
Is It Really Safe?
In our January 10, 2012 Patient Safety Tip of the Week “Verbal Orders” we noted that texted orders were not acceptable as per The Joint Commission. And for years we have shown in our medication safety presentations a texted order highlighted by ISMP “Slomag,” 64 mg TID “2Day,” that demonstrates how texted orders may be very confusing (ISMP 2009).
But now the Joint Commission has just reconsidered the issue of texted orders and rescinded its ban on them (TJC 2016a, TJC 2016b). According to the new TJC standards healthcare organizations may allow orders to be transmitted through text messaging provided that a secure text messaging platform is implemented that includes the following:
The Joint Commission further notes that the required elements of a complete medication order and actions to take when orders are incomplete or unclear must be clearly spelled out by the organizations and that policies and procedures for text orders should specify how orders transmitted via text messaging will be dated, timed, confirmed, and authenticated by the ordering practitioner. That also includes determining how text orders will be documented in the patient’s medical record.
We admit it – we are perplexed and astonished the The Joint Commission has rescinded its ban on texting medical orders. While we are big fans of use of technology in healthcare, opening up the door to texting orders is likely to create several patient safety vulnerabilities. The Joint Commission’s original ban on text messaging apparently was based primarily on the issue of how secure text messaging was. Since secure text messaging platforms are now available and such systems have been used successfully to facilitate other important aspects of patient care, The Joint Commission apparently feels that rescinding the ban on texting orders is appropriate. However, there are several issues that apply to texting orders above and beyond the use of texting for conveying other sorts of patient information.
Many CPOE systems currently have available remote access via smart phone applications so we would wonder why anyone with such systems would allow text orders at all. But many healthcare organizations may not have such capabilities and will be considering the use of texted orders in view of The Joint Commission’s new position. A recent survey of Medscape readers shows over 70% of respondents looking at texted orders favorably (Medscape 2016) so we anticipate many healthcare organizations are likely to adopt their use. But below are some of the issues that make us leery of texting orders:
Bypassing CDSS tools
One problem that immediately comes to mind is that many EMR systems have an order entry pathway used by nurses (or pharmacists) that is distinct from the typical CPOE pathway in which physicians enter orders. Alerts and other clinical decision support tools available on CPOE may not be available on these alternate order entry pathways. Hence, a texted order would require a nurse to actually enter the order and important patient safety safeguards may be bypassed. Each organization would have to ensure that all the CDSS tools and alerts normally available to the physician would also be available to the person charged with actually entering the order into the system.
Taking the easy way
Texting orders may also be a path for shortcuts and workarounds. We’ve previously seen a clinical decision support system (CDSS) implemented in attempt to optimize ordering blood products. Physicians began to order blood products instead via verbal orders because it was easier to do. This bypassed the patient safety measures that had been built into the CDSS. Particularly since alert fatigue is so widespread we can anticipate that texting orders will be more often resorted to as a shortcut to avoid being bombarded with alerts.
Ordering in a vacuum
Thirdly, if a physician (or other professional allowed to enter orders) is texting in orders, he/she is likely in a remote location where he/she does not have access to the EMR. Hence, important clinical information that might influence the order won’t be available. We are especially concerned when “covering” physicians, who are not familiar with the patient, are texting in orders.
Promoting telephone tag
Fourthly, since there will be strict rules regarding the format and content of texted orders, we anticipate that a substantial number of orders will not meet requirements. When that happens, nurses (or pharmacists) will have to call or otherwise contact the prescriber and the subsequent “telephone tag” will likely add additional burdens to both nurses and physicians.
At least with verbal orders, the nurse receiving the order has the prescriber on the phone and can (and must) ask the appropriate questions. They must use readback and spellback to ensure they get the order correctly and get other clarifications. In our January 10, 2012 Patient Safety Tip of the Week “Verbal Orders” we encouraged those receiving verbal orders to also try to provide context for the ordering provider (allergies, lab values, other medications, medical conditions, etc.).
This one is the lurking giant. Anyone who has sent text messages from their smart phone is often surprised when they know they typed in a correct word yet another word has popped up in its place! That is the AutoCorrect function on your smartphone at work. A related function, AutoText, typically pops up a suggested word after you type in the first several letters of a word. If you happen to hit return (or some other method on your particular smart phone) the suggested word is placed in the text. Of course, if you are paying attention you will note that AutoText or AutoCorrect has inserted a wrong word and you will edit it. But someone who is the least bit distracted might overlook the inadvertent word substitution and send the text message with the name of the wrong drug instead. AutoText and AutoCorrect are great tools that help you in everyday activities and don’t usually result in any harm. But if you are texting orders and such an inadvertent word substitution occurs you may cause major harm. Imagine that you typed in what you thought was “hydrocortisone” and instead “hydrocodone” was substituted. We’d go as far as saying that AutoText and AutoCorrect should be disabled on any device that will be sending orders via text message.
Actually, one feature required for texted medical orders that may be better than verbal orders is verification of the prescriber. In our January 10, 2012 Patient Safety Tip of the Week “Verbal Orders” we pointed out that most facilities accepting verbal orders really have no means of verifying who is actually on the phone! When we ask nurses the usual response we get is “Well, we know their voices.”! At least a Joint Commission approved order texting system would have a means of identifying the prescriber. While that would likely be via an ID and password that could be “stolen”, those same vulnerabilities apply to use of CPOE in the hospital.
That an order was received, verified, and accepted needs to be conveyed back to the ordering physician. That also would likely be via a text message. So that raises the additional HIPAA issue about having patient information on a device (smartphone, tablet, etc.) that might accidentally be left somewhere.
These, and probably several others we did not think of yet, certainly raise our antennas about the patient safety issues associated with texting orders. What The Joint Commission should have done would be to grant a waiver to several healthcare organizations to pilot the concept of order texting and learn about its efficacy, safety, and unintended consequences before allowing everyone to jump on board. Perhaps they have already done that but we don’t see it in their preliminary announcements. We predict by this time next year we’ll be seeing lots of incidents related to texted orders being reported. Of concern is that many of these will simply be buried under the category of “medication errors” and the actual impact of texted orders will not be uncovered in a timely fashion.
We would highly recommend that any hospital or other healthcare facility contemplating use of text orders audit 100% of all such orders for at least 6 months and then incorporate some sort of periodic auditing/monitoring into the QI programs thereafter. You can also expect The Joint Commission to issue some further guidance on the issue by the end of June.
ISMP (Institute for Safe Medication Practices). Safety Brief: “2day” gets “86ed.” ISMP Medication Safety Alert! Acute Care Edition 2009; February 26, 2009
TJC (The Joint Commission). Orders – Texting. What is The Joint Commission's position on texting orders? The Joint Commission 2016
TJC (The Joint Commission). Update: Texting Orders. Joint Commission Perspectives 2016; 36(5): 15
Medscape Medical News. Reader Poll: Send Orders by Text Message? Medscape Medical News 2016; May 19, 2016
May 31, 2016
More Frailty Measures That Predict Surgical Outcomes
There are a number of systems and tools available for predicting surgical complication rates or mortality rates. But we’ve also done numerous columns highlighting that measures of frailty, including some very simple ones, may be valuable in predicting complications or adverse outcomes in patients undergoing surgery. Some of the simplest have included the timed up and go test, gait speed, handgrip strength, etc. Even just identifying patients who have fallen at least once in the previous six months can help identify patients at risk for complications of surgery.
Recently, several more studies have further demonstrated that simple measures of frailty are valuable preoperatively in predicting surgical complications. One such study assessed the value of the timed stair climb in predicting perioperative complications in patients undergoing abdominal surgery (Reddy 2016). Reddy and colleagues compared patient performance on the timed stair climb against results of the American College of Surgeons NSQIP risk calculator. They chose the timed stair climb because it correlates with blood pressure and heart rate changes as an indicator of stress. Over 97% of the patients were able to complete the timed stair climb test. Patients with slower stair climb times had increased complication rates, and in multivariable analysis, stair climb time was the single strongest predictor of complications. Patients with slower timed stair climbs also had greater deviations from predicted length of hospital stay. The timed stair climb actually had predictive value superior to that of the American College of Surgeons NSQIP risk calculator. The authors suggest further validation of the timed stair climb in larger populations and those undergoing other types of surgery. The test is simple to administer and takes less than a minute. The “course” is up and down a 7-step set of stairs and the average time is 18 seconds.
We mentioned above gait speed as a predictor of surgical complications. A new study looked at the relationship between 5-meter gait speed with operative mortality and morbidity in over 15,000 older adults undergoing cardiac surgery (Afilalo 2016a). Gait speed was an independent predictor of adverse outcomes after cardiac surgery, with each 0.1-m/s decrease conferring an 11% relative increase in mortality. Adding gait speed to the Society of Thoracic Surgeons risk prediction tool further increased the predictive value of the tool.
5-meter gait speed was also a component of the Short Physical Performance Battery (SPPB) studied recently by the same group (Afilalo 2016b) in patients undergoing surgical or transcatheter aortic-valve replacement (TAVR). The other components were 5 chair rises and a balance test. Afilalo and colleagues found in over 900 patients that the SPPB and the Fried+ frailty scales optimally predicted mortality and were the only scales to yield a significant integrated discrimination improvement when added to the Society of Thoracic Surgeons risk model
Note that another recent study on patients undergoing aortic valve replacement surgery used a modified version of Ganapathi’s frailty index which includes six variables (age >70 years, BMI <18.5, hematocrit <35%, history of stroke, albumin <3.5, and partially or totally dependent functional status) to predict mortality, morbidity and hospital length of stay (Esses 2016).
Another recent study compared a simple measure of upper-extremity frailty (UEF) in trauma patients age 65 and older (Toosizadeh 2016). Rapid elbow flexion speed during a 20-second trial, as measured by a wearable device, was compared to a validated modified Rockwood questionnaire, the Trauma-Specific Frailty Index (TSFI), as the gold standard for frailty. Parameters of the UEF indicative of slowness, weakness, and exhaustion during elbow flexion were independent predictors of the TSFI score. Correlations were also observed between UEF parameters and number of falls within a previous year, with highest correlation observed for elbow flexion slowness. The authors conclude that this simple test of 20-second elbow flexion may be practical and sensitive to identify frailty among hospitalized older adults. The UEF test is independent of walking assessments, reflects several frailty markers, and it is practical for bed-bound patients.
And yet another study showed that the Modified Frailty Index was predictive of postoperative critical care support after surgery for head and neck cancer (Abt 2016). Their Modified Frailty Index, however, included 15 variables. It is not known whether simpler measures of frailty would have been as useful in predicting complications.
And since we mentioned above the American College of Surgeons NSQIP Surgical Risk Calculator we should mention that it has recently been recalibrated and updated (Liu 2016). Before recalibration there apparently was a tendency for it to overestimate risks for the lowest and highest risk patients. The authors concluded that performance of NSQIP Surgical Risk Calculator models was shown to be excellent and was improved with recalibration. Surgeons and patients can rely on the calculator to provide accurate estimates of surgical risk.
While we would recommend that anyone contemplating surgery (surgeon or patient) estimate risk using a validated tool like the ACS NSQIP surgical risk calculator, we really like the increasing use of simpler measures of frailty, at least in the 65 and older population, as predictors of complications, morbidity and mortality. These simpler measures can be easily performed in the office setting and are not time consuming.
And don’t forget that these simple measures, like gait speed assessment, may also be valuable in patients not undergoing surgery. Another recent study assessed the relationship between gait speed and the risk for death and/or hospital admission in older patients with heart failure (Pulignano 2016). Gait speed was measured over 4 meters in over 300 community-dwelling patients age 70 or older who had heart failure. One-year mortality rates were 38.3%, 21.9%, and 9.1% for those with gait speeds of ≤0.65 m/s, 0.66 to 0.99 m/s, and ≥1.0 m/s. Gait speed was also associated with a lower risk for hospitalization for HF and all-cause hospitalization.
Some of our prior columns on preoperative assessment and frailty:
Reddy S, Contreras CM, Singletary B, et al. Timed Stair Climbing Is the Single Strongest Predictor of Perioperative Complications in Patients Undergoing Abdominal Surgery. Am J Surg 2016; article in press accessed February 29, 2016
Afilalo J, Kim S, O'Brien S, et al. Gait speed and operative mortality in older adults following cardiac surgery. JAMA Cardiol 2016; Published online May 11, 2016
Afilalo J, Lauck S, Kim DH, et al. Frailty assessment in older adults undergoing transcatheter or surgical aortic valve replacement: The FRAILTY-AVR study. J Am Coll Cardiol 2016; 67(13_S):8-8
Toosizadeh N, Joseph B, Heusser MR, et al. Assessing Upper-Extremity Motion: An Innovative, Objective Method to Identify Frailty in Older Bed-Bound Trauma Patients. J Am Coll Surg 2016; article in press
Esses G, Deiner SG, et al. 2015 annual meeting of the ASA (abstract A2105) as described in Vlessides M. Simple Frailty Assessment for Fragile Aortic Valve Surgery Patients Predicts Morbidity, Mortality and Hospital LOS. Anesthesiology News 2016; March 17, 2016
Abt NB, Richmon JD, Koch WM, et al. Assessment of the Predictive Value of the Modified Frailty Index for Clavien-Dindo Grade IV Critical Care Complications in Major Head and Neck Cancer Operations. JAMA Otolaryngol Head Neck Surg 2016; Published online May 12, 2016
Liu Y, Cohen ME, Hall BL, Ko CY, Bilimoria KY. Evaluation and Enhancement of Calibration in the American College of Surgeons NSQIP Surgical Risk Calculator. J Amer Coll Surg 2016; Publication stage: In Press Accepted Manuscript (accessed May 20, 2016)
ACS NSQIP Surgical Risk Calculator
Pulignano G, Del Sindaco D, Di Lenarda A, et al. Incremental Value of Gait Speed in Predicting Prognosis of Older Adults with Heart Failure: Insights From the IMAGE-HF Study. JACC: Heart Failure 2016; published online March 9, 2016
June 7, 2016
CPAP for Hospitalized Patients at High Risk for OSA
Most of our focus on obstructive sleep apnea (OSA) in the hospitalized patient has focused on the perioperative period (see list of prior columns below). But OSA prevalence is also high in patients admitted to medical (non-surgical) units. In our July 2010 Patient Safety Tip of the Week “Obstructive Sleep Apnea in the General Inpatient Population” we noted that screening with the STOP and Berlin questionnaires found a potential 60% prevalence of obstructive sleep apnea in patients admitted to general medicine units in an urban academic hospital, most of whom had never been diagnosed with OSA. Many of the patients were obese and most had comorbidities. A high percentage of these patients received intravenous narcotics or were prescribed benzodiazepines or both and none of these received any supplemental respiratory monitoring. The study highlights the risk of using such medications in potentially high risk patients and also highlights the potential benefits of using simple tools like STOP in identifying potential OSA candidates.
In our prior columns we’ve also discussed the relative paucity of evidence for use of CPAP in hospitalized patients deemed at high risk for OSA by screening.
Now a new study addresses both issues. Sharma and colleagues (Sharma 2016) used the STOP tool to screen obese patients (BMI ≥ 30 kg/m2) admitted to select medical (non-surgical) services and sorted them into high- and low-risk for OSA groups. They found that rapid response system (RRS) activations were significantly more frequent in those patients in the high-risk group. Moreover, high-risk patients who were put on PAP (CPAP, BiPAP, or APAP) and were compliant with PAP were significantly less likely to have RRS activations than those high-risk patients not compliant with PAP or not receiving PAP.
They screened over 2500 inpatients over a 15-month period and found that 76% were at high risk for OSA (“Yes” answer to 2 or more of the 4 questions in STOP). Admitting teams were notified when a high risk designation was made and whether to get a Pulmonary/Sleep Medicine consultation was left up to the admitting team. Slightly less than half the high-risk group received such consultations. Note that patients with known OSA were excluded from the analysis. Of those who received consultations, PAP (usually CPAP but BiPAP or APAP for some) was recommended for almost three quarters. Almost 70% of the latter were deemed compliant with PAP (based on at least 4 hours PAP use during sleep noted by respiratory therapists).
The RRS activation rate per 1000 admissions was 43.6 for patients at high risk for OSA vs. 25.9 in low-risk patients. For PAP-compliant patients the RRS activation rate per 1000 admissions was 16.99 vs. 53.4 in PAP non-compliant patients. In addition, mean hospital LOS (length of stay) was significantly higher in the high risk group (7.52 vs. 6.98 days). The study implies (but does not actually include the data) that those patients compliant with PAP had lower mean LOS.
The study was an observational study and because it was not randomized there may have been biases or confounding factors that affected the decision to use PAP. As the authors appropriately note, it is also not surprising that patients at high risk for OSA would have longer LOS since they also likely have more comorbidities.
But this study certainly lays the foundation for larger randomized controlled studies. While it would have been useful to have data on other outcomes, the beneficial effect of PAP on reducing RRS activations and LOS would seem to justify further study not only for patient safety concerns but also potentially for the bottom line of hospitals.
We’ve always strongly advocated screening pre-op patients for OSA risk with the STOP-Bang tool. This study would suggest we might extend such screening to all inpatients who have at least a high BMI. We already recommend any hospital inpatient who will be receiving opioids be screened with the STOP-Bang questionnaire. Though we recommend universal use of capnography for inpatients on opioids, those hospitals with limited resources should at least be using capnography or otherwise monitoring for apnea in patients at high risk for OSA who are receiving opioids. The current study is also another one on the “pro-“ side for using PAP in hospitalized patients deemed at high risk for OSA, though further definitive research is needed.
Our prior columns on obstructive sleep apnea in the perioperative period:
June 10, 2008 “Monitoring the Postoperative COPD Patient”
August 18, 2009 “Obstructive Sleep Apnea in the Perioperative Period”
August 17, 2010 “Preoperative Consultation – Time to Change”
July 13, 2010 “Postoperative Opioid-Induced Respiratory Depression”
November 2010 “More on Preoperative Screening for Obstructive Sleep Apnea”
February 22, 2011 “Rethinking Alarms”
November 22, 2011 “Perioperative Management of Sleep Apnea Disappointing”
May 22, 2012 “Update on Preoperative Screening for Sleep Apnea”
February 12, 2013 “CDPH: Lessons Learned from PCA Incident”
February 19, 2013 “Practical Postoperative Pain Management”
March 26, 2013 “Failure to Recognize Sleep Apnea Before Surgery”
September 24, 2013 “Perioperative Use of CPAP in OSA”
May 13, 2014 “Perioperative Sleep Apnea: Human and Financial Impact”
March 3, 2015 “Factors Related to Postoperative Respiratory Depression”
August 18, 2015 “Missing Obstructive Sleep Apnea”
Sharma S, Chowdhury A, Tang L, et al. Hospitalized Patients at High Risk for Obstructive Sleep Apnea Have More Rapid Response System Events and Intervention Is Associated with Reduced Events. PLOS One 2016; Published: May 11, 2016
June 14, 2016
Nursing Monitoring of Patients on Opioids
Opioid-induced respiratory depression has long been one of our most frequently discussed patient safety issues (see the full list of our prior columns at the end of today’s column). Shortly after The Joint Commission issued its Sentinel Event Alert “Safe Use of Opioids in Hospitals” in 2012 (see our September 2012 What's New in the Patient Safety World column “Joint Commission Sentinel Event Alert on Opioids”), CMS (Centers for Medicare and Medicaid Services) announced its intent to develop a quality measure related to monitoring hospitalized patients receiving opioids. CMS’s intention was to develop a measure that could collected via data submitted electronically from EMR’s. And, while patients receiving opioids via any route are at risk for respiratory depression, it was felt that the most accurate measures could be determined on those patients receiving opioids via PCA (patient-controlled analgesia).
Eight US hospitals volunteered to participate in pilot data collection for CMS. A report of the results of that pilot data were recently published and should be a wake-up call for all hospitals (Jungquist 2016).
The data came from nurse-abstracted electronic medical records and focused on the monitoring of 3 key indicators and 2 key timeframes:
The two timeframes looked at were every 4.5 hours and every 2.5 hours. Actually, the two intended timeframes were 2 and 4 hours but it was felt that it might take up to 30 additional minutes for entry of the indicators into the EMR so the extra 0.5 hours was added to each timeframe.
Strikingly, only 8.4% of the patients had full monitoring of all 3 parameters as per the specifications of the measure. Even at the 4.5 hour timeframe only 26.8% had all 3 assessments.
A very important finding was that naloxone administration, used to rescue patients with respiratory depression, was not needed in any patient who was assessed at least every 2.5 hours (1.3% of all patients on PCA received naloxone).
Note that the hospitals in this pilot project had different local policies regarding monitoring patients on PCA so it should not be surprising that the overall compliance rates varied by hospital. Those hospitals that allowed PCA only in higher levels of care had higher compliance rates.
We’ve, of course, discussed appropriate monitoring of patients receiving opioids on many occasions and strongly recommend use of capnography and/or apnea monitoring. Pulse oximetry by itself, whether episodic (“spot check”) or continuous, can be misleading, especially in patients receiving supplemental oxygen. Similarly, monitoring respiratory rate visually is misleading unless you are sure to watch the respiratory rate while the patient is asleep. There was extreme variability of the respiratory rate measurements in the study, perhaps reflecting different rates when the patient was awake or asleep (note that most EMR’s don’t currently capture the state of awakeness when the respiratory rate is measured). The authors of the current study allude to the fact that certified nursing assistants often do the respiratory rate measurement so must be educated on how to appropriately assess the respiratory rate.
Use of a numeric sedation scale, like the Pasero Opioid-induced Sedation Scale (POSS) or the RASS (Richmond Agitation Sedation Scale), is most helpful in patients receiving episodic rather than continuous opioids (see our May 6, 2014 Patient Safety Tip of the Week “Monitoring for Opioid-induced Sedation and Respiratory Depression”). Before the next dose of an opioid is given a nurse would assess the patient’s level of sedation and determine whether the next dose should be given as ordered, or withheld, or adjusted. It is somewhat less useful when patients are using PCA but still should be done since a nurse might recommend cessation of PCA if a patient is too sedated while using PCA. If the sedation scale parameter were removed from the proposed CMS quality measure, the overall compliance rates would increase to 33.4 % at 2.5 hours and 53.9% at 4.5 hours.
The authors of the current study also note that monitoring trended data rather than just looking at threshold rates may be important. We concur but with the caveat that, particularly in patients with obstructive sleep apnea, changes may occur precipitously without an antecedent worrisome trend.
The Jungquist paper has good references to the evidence-based guidelines for monitoring patients receiving opioids as do our many columns listed below.
Perhaps the best advice made by Jungquist and colleagues is that “electronic monitoring should complement and not replace vigilance in nursing assessments and monitoring practices”. We concur wholeheartedly.
CMS may need to rethink some of the technical and practical issues involved in data collection for this much-needed quality measure. But every hospital needs to take a good look at its own current practices for monitoring patients receiving opioids regardless of whether CMS or other regulatory body is collecting data on such. You will likely find you have some work to do to get your organization up to snuff on best practices for monitoring your patients who are on opioids.
Our other Patient Safety Tips of the Week pertaining to opioid-induced respiratory depression and PCA safety:
Jungquist CR, Correll DJ, Fleisher LA, et al. Avoiding Adverse Events Secondary to Opioid-Induced Respiratory Depression: Implications for Nurse Executives and Patient Safety. J Nurs Admin 2016; 46(2): 87-94
June 21, 2016
Methotrexate Errors in Australia
We’ve now done multiple columns on errors with methotrexate therapy. The basic problem is that methotrexate is used in different doses and different regimens when used for oncological indications or immunomodulating indications for conditions like rheumatoid arthritis, psoriasis, and inflammatory bowel disease. For the latter conditions, low dose methotrexate is used (typically administered weekly in doses that might be in the 7.5-25 mg range).
Now the Australian experience with serious methotrexate errors has been published (Cairns 2016). Cairns and colleagues analyzed 3 separate databases over a 10-14 year period and found numerous cases, including fatalities, of errors related to methotrexate dosing. An important point noted was that there was almost no overlap of cases reported to these three databases, suggesting that there is likely overall underreporting of such cases. And especially concerning was that there appeared to be a significant increase in calls to their poison information center about methotrexate over the last two years.
In one database they identified 22 cases where methotrexate was listed as a cause of death, including 7 cases that had dosing errors recorded and showed patients had taken methotrexate for between three and ten days consecutively. Of the 7 cases where dosing errors were recorded, three were due to dosette packaging errors by pharmacists, one to a prescribing error, one to mistaking methotrexate for another medication, one to an error by a carer, and one to prescriber-patient miscommunication.
In a second database they found 16 reports of methotrexate-related adverse events, including 5 deaths, and again found unintended daily dosing in 10 cases. In those cases where reasons for errors were available, 11 cases involved mistaking methotrexate for another medication (most often folic acid or prednisone). Five cases were due to error by a carer or nursing home. Other reasons noted were newly prescribed methotrexate, dosette packing errors by pharmacists, misunderstood instructions, prescribing error, dispensing/labeling error, and one case where the patient believed it would improve efficacy.
The authors note that guidelines in place had already recommended extended patient counselling, designating a specific day of the week to take methotrexate, and use of smaller drug packs. Australia introduced smaller pack sizes for methotrexate (10 mg x 15 tablets) but most methotrexate remains dispensed in the larger (10mg x 50 tablets) packs.
The study emphasized that taking methotrexate daily for even 3 consecutive days could be fatal but noted wide variability in the duration of daily dosing before toxic effects occurred. Some patients took it daily for weeks before toxicity became apparent. Possible contributory factors cited included increasing patient age, renal function and hydration status.
The authors also noted that folate and methotrexate are both small yellow tablets, likely increasing the chance the two might be mixed up. They suggested that formulating methotrexate as a distinctively colored tablet might help. They also recommend clear labeling that the medication is taken weekly and that taking it daily could be harmful. Another recommendation was to co-package with folate in a manner akin to the way contraceptives and sugar pills are packaged. Both these potential solutions would require manufacturers/suppliers to implement changes. But don’t hold your breath - drug manufacturers have little incentive to change packaging, etc. because methotrexate is now a low cost drug.
And, of course, they recommend that clinical decision support tools be utilized in both CPOE/e-prescribing systems and pharmacy IT systems to provide alerts aimed at preventing daily dosing errors.
Since first-time users and older patients appear to be at greater risk, they emphasize the importance of taking time to counsel these patients. The authors also note that in addition to physiologic changes that might alter methotrexate metabolism and excretion, the elderly may have other problems like confusion, memory impairment, visual decline, and others that could put them at increased risk of dosing errors. Regarding counselling of patients and/or caregivers, we’d also like to reiterate that ISMP provides a great consumer leaflet with safety tips for patients taking methotrexate.
We are not surprised that the Australian researchers found some errors related to nursing homes. In our What's New in the Patient Safety World columns for July 2011 “More Problems With Methotrexate” and February 2016 “Avoiding Methotrexate Errors” we noted that the patient in a long-term care facility may be especially vulnerable. In such cases, the original order for methotrexate is usually written by a specialist. The patient is then followed in the LTC facility typically by a primary care physician who may be less knowledgeable about the particular use of methotrexate for that condition. Also, the LTC patient may not be seen by a physician for periods as long as a month. And many LTC patients have cognitive impairments that might prevent them from understanding issues about their medications. So if a medication reconciliation error has occurred and a patient intended for once weekly dosing is now on daily dosing, the opportunity for toxicity is greatly increased. So LTC facilities should take steps to ensure that any of their residents taking methotrexate get the same level of supervision and protections that non-LTC patients would get.
Not mentioned in the Australian study are drug-drug interactions. Our February 2016 What's New in the Patient Safety World column “Avoiding Methotrexate Errors” noted examples of such drug-drug interactions in leading to methotrexate toxicity (like NSAID’s and proton pump inhibitors, amoxicillin and leflunomide) (ISMP Canada 2015). That ISMP Canada article also noted predisposing factors such as hypoalbuminemia and renal dysfunction in leading to methotrexate toxicity.
In several of our columns on patients receiving lethal doses of chemotherapy we have questioned why one would ever prescribe or dispense or administer a dose of a drug that could be potentially lethal if the total dose were inadvertently given. Most of those have pertained to patients receiving IV chemotherapy where a dose intended to be administered over several days ran in instead over one day or even just hours. But the same argument applies to oral methotrexate. Imagine if an ordering physician or dispensing pharmacist was required to tell a patient each time “I am ordering/dispensing for you a potentially lethal dose of this medication”. How many patients do you think would say “that’s ok, I’d rather have the convenience of not having to refill my prescription once a month”? That’s a point also made in the editorial (MacKee 2016) accompanying the Australian study which quoted one professor of clinical pharmacology as recommending providing only a 1-month supply to prevent dosing errors. He said “It is difficult to have a five-times overdose of methotrexate when you only have four tablets in a month.”
A very real problem here, of course, is that we have a drug that is used in very different doses and regimens for two different conditions. If we were just starting to use a new drug for two potentially very different conditions requiring such differences in dosing and regimens, we might well consider giving the drug two different names. For example, we might name one methotrexate and use if for conditions like rheumatoid arthritis, psoriasis, inflammatory bowel disease, etc. And the one for oncology we might name something like “Folic acid inhibitor X”. The two pills could be manufactured as pills of different colors. Could we do such a thing now? We don’t think so. Trying to do this today would likely lead to unintended consequences that would cause more harm than good.
Restrictive formularies could be a potential solution. For hospitalized patients, restrictions can be put in place so that only oncologists can order daily methotrexate. On the outpatient side, managed care organizations often have restrictive medication practices in which certain drugs can only be prescribed by certain specialists. So why cannot they require prior authorization for prescriptions for more than “x” amount of methotrexate if ordered by someone other than an oncologist? They could, but that solution obviously would apply to only a minority of patients being prescribed methotrexate.
But keep in mind that, in the Australian experience, some patients developed toxicity even when taking methotrexate as few as 3 days consecutively. So even if you were to restrict dispensing of methotrexate to only 4 tablets at a time (supposedly a month’s total dose), a patient theoretically could still develop toxicity if they took the 4 tablets on consecutive days rather than one a week. But limiting dispensing to just a one month supply would certainly go a long way to reducing the chance of inadvertent daily dosing errors with serious or fatal outcomes.
It’s worth repeating here the several practical recommendations made by ISMP Canada (ISMP Canada 2015) discussed in our February 2016 What's New in the Patient Safety World column “Avoiding Methotrexate Errors” for IT systems, prescribers, and pharmacists.
On the IT side, it recommends that CPOE and pharmacy IT systems should default to a weekly dose. If a daily dose is ordered there should be a hard stop requiring input of the indication and duration of treatment. It recommends provision of an alert about potential serious adverse effects of daily dosing, particularly in patients with some of the above risk factors or taking any of the interacting medications, with suggestions for monitoring. It also suggests linking lab results to order entry for methotrexate (eg. CBC, LFT’s, albumin, creatinine) so the prescriber and pharmacist can be reminded to check for risk factors and be reminded of parameters they may need to monitor.
It also recommends a robust drug-drug and drug-disease interaction module for methotrexate. That one is the most problematic. We already know that drug-drug and drug-disease and drug-food alerts are among the alerts most often ignored by prescribers. Many EHR’s and CPOE or e-prescribing systems allow for configuration of alerts to allow only certain more serious alerts to be shown. But some do not allow selective enabling of these alerts (i.e. allowing drug-drug or drug-disease alerts for just high alert medications as opposed to all medications).
On the prescriber side it recommends baseline values for parameters that may need to be monitored during therapy (eg. CBC, LFT’s, creatinine) and notes that a good order entry system could prompt the provider to order these at the time methotrexate is being ordered. It also has recommendations for frequency of monitoring these parameters, screening for hepatitis B and C and HIV prior to initiating therapy, and considering folate supplementation.
It has 2 excellent recommendations to avoid the error of patients getting daily methotrexate rather than intended once weekly methotrexate:
It also reminds the prescriber to ask the patient about specific prescription and any OTC medications they may be taking that could increase the likelihood of methotrexate toxicity.
On the pharmacist side it recommends a forcing function be developed to ensure that every prescription of methotrexate is reviewed with the patient (or caregiver). The patient should be counselled and given written information about methotrexate and stress the importance of adhering to the prescribed dose and monitoring. If folate supplementation has not been prescribed the pharmacist should contact the prescriber. The pharmacist should follow up on any drug interaction alerts that may appear and discuss with the prescriber and patient. Specific discussion about OTC medications or other medications known to interact with methotrexate should occur. And, again, the supply dispensed should only be for 4 weeks.
Most of the same recommendations appear in an article in the rheumatology literature (Blank 2015). This article has a couple more practical recommendations. It notes that use of a “dose pack” may help guide patients to take the proper weekly dose for non-oncologic indications. When reviewing the dosing schedule with patients it is important to explain that taking extra doses is dangerous and discuss that the medication is not to be used “as needed” for symptom control. Have the patient repeat back the instructions to validate that he or she understands the dosing schedule and toxicities of the medication if taken more frequently than prescribed.
By the way, did you notice we did not use the abbreviation “MTX” for methotrexate? That abbreviation is on the ISMP “Do not use” list of abbreviations because it may be confused with mitoxantrone. So use of that abbreviation would be another potential error involving methotrexate. Is “MTX” on your “Do not use” abbreviation list?
Our prior columns related to methotrexate issues:
Our prior columns related to chemotherapy safety:
Cairns R, Brown JA, Lynch A-M, et al. A decade of Australian methotrexate dosing errors. Med J Aust 2016; 204(10): 384
ISMP (Institute for Safe Medication Practices). Consumer Leaflet with Safety Tips for Methotrexate. 2013
ISMP Canada. Severe Harm and Deaths Associated with Incidents Involving Low-Dose Methotrexate. ISMP Canada Safety Bulletin 2015; 15(9): 1-5
MacKee N. Preventable methotrexate errors need a fix. MJA InSight 2016; Monday, 6 June, 2016
Blank C. 10 Ways to Avoid Fatal Methotrexate Errors. Rheumatology Network 2015; December 2, 2015
ISMP (Institute for Safe Medication Practices). ISMP’s List of Error-Prone Abbreviations, Symbols, and Dose Designations. ISMP 2015
Print “Methotrexate Errors in Australia”
June 28, 2016
Culture of Safety and Catheter-Associated Infections
A study recently published garnered lots of national headlines implying that we don’t need to change our culture to improve outcomes. While we can’t speak for the authors of that study, we don’t think the headlines generated were what they intended.
University of Michigan researchers (Meddings 2016) looked at responses on the Hospital Survey on Patient Safety Culture (HSOPS) survey at hospitals participating in two prospective cohort studies from acute-care intensive care units (ICUs) and non-ICUs participating in the AHRQ CLABSI and CAUTI collaboratives, including one (Saint 2016) we’ve highlighted in our July 2016 What's New in the Patient Safety World column “Holy Moly, My Patient has a Foley!”. Among responding units, infection rates declined over the project periods, by 47% for CLABSI and 23% for CAUTI. But Meddings and colleagues found no correlation between the CLABSI and CAUTI rates at these units and the HSOPS measures either at baseline or at one year. Those results were contrary to the authors’ hypothesis that the improvements seen would correlate with scores indicating a culture of safety as measured by HSOPS.
Meddings et al. conclude their results show one of two possible things:
The implications are significant. If the former is true, many projects could be streamlined by eliminating many of the time and other resources put into developing a culture of safety. If the latter is true, time could also be saved by eliminating a measure that is also time-consuming and adds little value.
Yes, you can use constraints or forcing functions to promote use of standardized techniques and procedures (for example, requiring completion of a checklist before a central venous catheter kit can be opened). But if you don’t get buy-in from most physician and nursing staff that the standardized techniques and procedures are the right thing to do to improve patient safety, your likelihood of success will be diminished.
Note that we have stressed over and over that, in our opinion, the primary reason we’ve failed to significantly improve patient safety has been our inability to develop a culture of safety in our organizations. You’ve heard us use the phrase “culture trumps ________” (fill in the blank with words like policy, procedure, strategy, tactics, vision, etc). In fact, “Culture trumps…Everything!”. When we do root cause analyses (RCA’s) on cases with adverse outcomes we very often find that the culture of the unit tolerated workarounds or shortcuts or was such that it discouraged healthcare workers from speaking up when they knew something was wrong. We have wholeheartedly agreed with John Nance’s view that the reason healthcare has not achieved the results that the aviation industry has attained in safety is that healthcare has failed to change our culture (see our June 2, 2009 Patient Safety Tip of the Week “Why Hospitals Should Fly...John Nance Nails It!” and our January 2011 What's New in the Patient Safety World column “No Improvement in Patient Safety: Why Not?”).
And “failure to embrace a culture of safety” made the most recent ECRI Institute’s Top Ten Patient Safety Concerns for 2016 (see our May 2016 What's New in the Patient Safety World column “ECRI Institute’s Top Ten Patient Safety Concerns for 2016”).
And all the good work done at Johns Hopkins and the Michigan Keystone Collaborative utilizing CUSP’s (Comprehensive Unit-based Safety Programs) has emphasized the importance of culture at the unit level (see our March 2011 What's New in the Patient Safety World column “Michigan ICU Collaborative Wins Big”). In fact, CUSP principles were a key component of the two national collaboratives in the current Meddings study.
So does the recent Michigan study really mean you don’t have to change organizational culture to effect improvement and you should abandon your efforts to develop a culture of safety? Or does it just mean that the tools used to “measure” culture are not very useful. We’ll opt for the latter explanation. We’ve never been fans of the variety of “culture” surveys that are widely used. When applied to assess the “culture” of an organization as a whole they can be terribly misleading. Culture at the unit level is much more important. All the surveys out there tend to show the same thing: physicians and administrators all have a more positive view of the “organizational culture” than do nurses and other frontline personnel. And the culture often varies dramatically from unit to unit. And people often respond to such surveys with the answers they think you want to hear rather than what they actually think, even when the surveys are “anonymous”.
We’ve always found that you get a much better feel for the “culture” of a unit on your Patient Safety Walk Rounds than you get from any formal survey. When you have direct interaction with frontline staff in an informal and non-punitive fashion, they are more likely to be forthcoming and point out potential vulnerabilities that they might not when responding to a formal survey or questionnaire. Our October 7, 2014 Patient Safety Tip of the Week “Our Take on Patient Safety Walk Rounds” discusses in detail how you can make such rounds valuable and help improve your culture of safety (and also warns how you can misuse such rounds to be detrimental in promoting a culture of safety!).
Where we do concur with Meddings et al. is that using HSOPS responses in large quality improvement collaboratives is time-consuming and may add little value. It should be noted that in the Meddings study HSOPS response rates were low overall, 24% for the CLABSI collaborative and 43% for the CAUTI collaborative. Those low rates of response may well reflect that participants found HSOPS to be time-consuming and they gave little importance to its inclusion in the projects. We really doubt that the authors would recommend eliminating use of the CUSP principles from such projects. Rather, we concur with the second theory espoused by Meddings et al. that HSOPS was not designed to provide a valid measure of safety culture impacting care at the bedside. Meddings et al. also point out that safety culture can be very difficult to measure over time, particularly since changes in staffing and resources and competing priorities commonly occur during the timeframes of such measurement. If you are going to eliminate anything from such quality improvement projects, take out the culture surveys.
So beware of media headlines that seem to imply that safety culture may not be so important.
Some of our prior columns related to the “culture of safety”:
April 2009 “New Patient Safety Culture Assessments”
June 2, 2009 “Why Hospitals Should Fly...John Nance Nails It!”
January 2011 “No Improvement in Patient Safety: Why Not?”
March 2011 “Michigan ICU Collaborative Wins Big”).
March 29, 2011 “The Silent Treatment: A Dose of Reality”
May 24, 2011 “Hand Hygiene Resources”
March 2012 “Human Factors and Operating Room Safety”
July 2012 “A Culture of Disrespect”
July 2013 “"Bad Apples" Back In?”
July 22, 2014 “More on Operating Room Briefings and Debriefings”
October 7, 2014 “Our Take on Patient Safety Walk Rounds”
July 7, 2015 “Medical Staff Risk Issues”
September 22, 2015 “The Cost of Being Rude”
Meddings J, Reichert H, Greene MT, et al. Evaluation of the association between Hospital Survey on Patient Safety Culture (HSOPS) measures and catheter-associated infections: results of two national collaboratives. BMJ Qual Saf 2016; Published Online First 24 May 2016
Saint S, Greene MT, Krein SL, et al. A Program to Prevent Catheter-Associated Urinary Tract Infection in Acute Care. N Engl J Med 2016; 374: 2111-2119
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