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August 20, 2019
Yet Another (Not So) Unusual RSI
Hard to believe it’s been over 3 years since our last column on RSI’s (retained surgical items) or RFO’s (retained foreign objects), especially since “unintended retention of a foreign body” remains The Joint Commission’s top reported sentinel event. There were 111 such events reported to The Joint Commission in 2018 (TJC 2019a) and 116 in 2017 and 60 so far in the first half of 2019 (TJC 2019b).
But there have been some interesting, and troubling, trends. While surgical sponges remain the most frequently retained surgical items, the nature of retained items has been changing over the last few years and a number of unusual items have been reported.
Three cases recently published by the California Department of Public Health (CDPH) provide insight into factors contributing to retention of some surgical items.
The first incident recently published by the CDPH (CDPH 2019a) illustrates how multiple factors contributed to retention of a viscera retainer after a hernia repair. That retained foreign object was found during a second surgery conducted after the patient presented several weeks later with an infected wound that had opened.
The original case had been the last case of the day and the most complicated. It started out as a laparoscopic hernia repair but was converted to an open procedure because the hernia was large. During the procedure, the surgeon requested a silastic viscera retainer (VR). The relief circulating RN (CRN) was unfamiliar with this and the OR tech told him what it as and where to find it in a storage cabinet. The CRN “was nervous” and dropped the VR as he attempted to put it on the sterile field and it fell to the floor. He got another VR and put it on the sterile field. The VR that fell on the floor was later put in the kick bucket. Apparently neither VR was written on the whiteboard.
During the surgery the viscera retainer was placed over the intestines to prevent suturing the mesh to the bowel, then the mesh was placed on top.
At some point during the surgery there was a change in personnel. The First-Assist Physician’s Assistant (FAPA) stated she stayed 2 hours past her shift to assist the surgeon and then she asked to leave the surgery. An OR tech came in to relieve the FAPA. The OR tech stated he did not remember receiving report from the FAPA that a VR was used during the surgery. The OR tech also stated he did not remember seeing the ring or the tail from the VR on the surgical drape outside the patient’s incision.
The surgeon, when interviewed several months after the initial surgery, could not recall putting the VR in or taking it out, but did recall, as he was closing, asking for a count and being told it was correct, so he proceeded to close. Both the CRN and the OR tech saw the VR in the kick bucket and thought the count was correct.
It was not clear who actually put the VR in, but it was speculated that might have been the FAPA before being relieved by the OR tech.
The second case (CDPH 2019b) involved retention of a surgical ribbon malleable instrument, measuring 12.99 inches by 2 inches after a C-section and tubal ligation surgery. The patient returned to the ED with abdominal pain 29 days after surgery and CT scan showed a large metallic density foreign body.
Specialty technician (Tech 1) explained that, during the third count, she was holding a retractor while assisting the surgeon to retract the patient’s skin. Tech 1 stated that she started counting retractors from the patient to the table by visualizing the retractor and verbally counting out the number corresponding to that retractor. Tech 1 advised she counted 7 retractors. However, she explained that she verbally out load said the number “8”, assuming the eighth retractor was already inside the basket. Tech 1 stated “I did not have a visual of the eighth retractor. I assumed the eighth retractor was inside or behind the basket.” (The basket is a metal wire container where the instruments are placed).
The Surgical Services Director explained that the surgical team staff had not performed the instrument counts as mandated by facility policy, explaining that the surgical instruments were not counted audibly nor viewed concurrently by the circulating nurse and the scrub tech and confirming that the eighth retractor was not visualized by the two surgical staff.
Tech 1 explained that the “third” count occurred at the surgical suturing of the peritoneum. She stated that several distractions occurred during this part of the procedure. The primary surgeon dismissed the assistant surgeon at this point of the procedure. Tech 1 indicated that she then assumed the role of assistant to the primary surgeon. Tech 1 described having to hold an instrument to retract the wound with her right hand, while holding a needle holder with her left hand in preparation for the surgeon's next step in the procedure. Her attention to the surgeon’s needs made it difficult for her to visualize all the retractors as the counts were performed. When the circulating nurse named a countable item, the tech used her head to point to the countable item. At this point, the patient began to cough, and the tech thought she might have vomited. At this point the surgeon asked for an instrument to hold back the wound as the patient’s body movement interrupted the surgical suturing of the wound. Tech 1 handed the surgeon a ribbon malleable retractor.
Tech 1 also explained that the ribbon malleable retractor was usually placed inside or in back of the basket. The circulating nurse stated that during the third count she called out “retractors” and thought the tech verbally replied aloud the number “8”. She said she did not actually see that retractor herself. Neither the nurse nor the tech actually saw the 8th retractor. They assumed it was in the basket.
There were several other distractions as the primary surgeon informed the assistant surgeon to leave. The surgeon’s phone rang several times during the third count, before being answered by the anesthesiologist. The patient had also vomited, which is why the surgeon asked for the malleable ribbon retractor.
The third case (CDPH 2019c) also involved retention of a ribbon retractor, measuring about 33 cm long, 5 cm wide, and one millimeter in thickness, after an abdominal hysterectomy by a resident physician. The day after surgery the patient complained of left sided chest pain radiating to her shoulder and a CXR was read as showing a left lower lobe infiltrate with small amount of pleural fluid. The patient was discharged but 20 days post-op she returned with abdominal pain and X-rays show the foreign body (this was actually the “lower lobe infiltrate” previously seen on CXR).
According to the surgical tech (ST), the surgeons used a standard laparotomy tray but, when they closed the abdomen, they asked for a malleable ribbon retractor. Apparently, only 2 counts were done. No final count was performed. “We didn't do final count for instruments, because (the} first (count} was correct.”
So, there is clearly a pattern in these cases.
First, and foremost, counts need to be conducted under “sterile cockpit” conditions. That means that all must focus attention on the count and there should be no extraneous conversations or other distractions.
Communication breakdowns are a key feature of most sentinel events and these are no different. In the first case, the OR tech stated he did not remember receiving report from the FAPA that a VR was used during the surgery.
Third, the potential impact of personnel changes is obvious in the above examples. In one case, the role of one of the persons responsible for the count was changed and she now was performing two roles, causing less than ideal attention to doing the count.
Other distractions included the surgeon’s phone ringing several times during a count. The issue of personal phones in the OR is beyond the scope of today’s column but the case at hand is a great example of a reason we counsel against allowing phones in the OR. Our Patient Safety Tips of the Week May 21, 2013 “Perioperative Distractions”, March 17, 2015 “Distractions in the OR”, and July 21, 2015 “Avoiding Distractions in the OR” had detailed discussion about use of cell phones and other wireless devices in and around the OR with multiple examples of distractions related to such in the OR. There are a multitude of issues related to cell phones in the OR including not only interruptions and distractions but also infection control issues, security and confidentiality issues, and detrimental effects on communication in the OR. Our recommendation is for all the OR team to leave their cellphones at the main OR desk where someone can triage incoming phone calls and messages.
Time of day was clearly a factor in the first case. It was the last case of the day and the First-Assist Physician’s Assistant (FAPA) stated she stayed 2 hours past her shift to assist the surgeon and then she asked to leave the surgery. In the other, it was not clear why the assistant surgeon was “dismissed” (was it also related to time of day?). Time of day is relevant for the fatigue factor, time pressures, and for contributing to the personnel changes.
Other unanticipated events were also contributing factors. In one, the original item fell on the floor, so a second item had to be put into the sterile field. In another, the patient began to vomit and move around.
There was also a common cognitive bias in at least one of the cases. That is the bias where we “see” what we expect to see and the related cognitive bias “inattentional blindness”. The tech assumed the retractor was in or behind the basked where the instruments were placed even though she did not actually see the instrument.
Unfamiliarity with the device played a role in at least one of the above cases. In the first case, the circulating nurse did not know what the device was or where it was located. The “ring” attached to the device was likely also inadequately anchored to remain visible.
Lastly, each of these cases involved problems with the “final” count. There is typically a count done when the wound cavity is closed and then a final count after the skin wound is closed. Most surgical instruments are introduced well before the wound cavity closure stage. But, in the cases with these retractors/retainers, the instrument is often introduced only after the penultimate count (the one following wound cavity closure) has been done. There is probably a natural tendency to forget to add that item to the whiteboard or whatever other tool is being used to log in instruments. This is also relevant with regard to the “methodical wound exploration” (MWE). The MWE is typically done before the “closing” count. But that means there is no MWE after the wound cavity is closed and the skin is sutured, i.e there is no MWE done just before the “final” count.
Also striking in the CDPH cases were the missed opportunities to identify the RSI soon after the fact, causing the patients unpleasant symptoms for several weeks before the correct diagnosis was made.
When we first planned this column many months ago, it was titled “Yet Another Unusual RSI”. But it turns out it is not so unusual. In fact, the most frequently reported retained instrument is the malleable or ribbon retractor according to NoThing Left Behind® (NoThing Left Behind® 2019). NoThing Left Behind® states “we have a better understanding of why malleable retractor cases have occurred. Usually during the closure of the wound the malleable retractor has been added to the field often as an add-in to the case, rather than as a part of the instrument tray. In most of the cases there has been some kind of distraction which has diverted attention from the field and the malleable has slipped away out of view. This alone should not lead to retention because the practice of instrument counting should detect the missing item. However either the instrument counts weren't performed or the added-on malleable wasn't included in the counting documentation and the retractor has been left inside.”
Interestingly, the solution proposed to prevent retention of the malleable ribbon retractors is use of the plastic fish viseeral retainer, which was the item retained in the first CDPH case. “These cases can be prevented with the use of a plastic fish visceral retainer which has a long cord and a ring at the end. The ring is clamped to the surgical drapes when the retainer is placed inside the abdomen during closure. The cord and ring are actually the safety part of the retainer.” (NoThing Left Behind® 2019).
Back in our November 5, 2013 Patient Safety Tip of the Week “Joint Commission Sentinel Event Alert: Unintended Retained Foreign Objects” we mentioned another case of a retained Glassman viscera retainer. That was from the investigation of a RFO reported by the California Department of Public Health (CDPH CA00235788). In this case the retained foreign object was a Glassman viscera retainer, which is a fish-shaped soft flexible device that folds into a roll and is used to shield from nicks and punctures. All the “counts” in the case were reported to be correct. But apparently when the “fish” was added to the surgical field it was not added to the count verbally or on the count board (see our January 8, 2013 Patient Safety Tip of the Week “More Lessons Learned on Retained Surgical Items” regarding addition of items to the surgical field). In addition, the “fish” apparently has a string attached to promote retrieval but that string had been cut by the surgeon. Guidelines for surgical sponges have always emphasized the importance of not cutting or altering the sponges. Obviously the same should apply to other things, like the “fish”.
In the current CDPH case (CDPH 2019a) staff did not recall seeing the fish ring or the connecting “tail”. The hospital’s plan of correction included re-educating surgical staff on use of a viscera retractor and methods for anchoring the FISH ring when the view is obscured. So it’s clear that you need to use the “Fish” correctly to take advantage of its built-in safety features.
While sponge accounting systems are at the top of everyone’s list of tools to prevent RSI’s because surgical sponges are far and away the most commonly retained surgical items, our previous columns warn you not to lose sight of the fact that all sorts of other RSI’s have been appearing more and more (blue towels, Kerlix, cautery tips, Glassman viscera container, KOH cup, instrument labeling tape, Jackson Pratt drain bulbs, Rainey clips, and, yes, a cell phone, and others). Even the newest radiofrequency identification and tracking systems would miss most of those items.
In addition to our many prior columns on RSI’s/RFO’s listed below, there are many good resources available to help prevent these. NoThing Left Behind® (NoThing Left Behind®) is the preeminent resource. Others include AORN (AORN 2018), the American College of Surgeons (ACS 2016), The Joint Commission (TJC 2017, TJC 2013), Pennsylvania Patient Safety Authority (Wallace 2017). Verna Gibbs,founder and director of NoThing Left Behind®, also recently provided some great tips for surgeons, nurses, and all OR staff for avoiding RSI’s (Gibbs 2019). And Victoria Steelman, another author of frequent publications on RSI’s, and her colleagues have also published recent articles on RSI’s (Steelman 2018, Steelman 2019)
Our prior columns on retained surgical items/retained foreign objects (RSI’s/RFO’s):
References:
TJC (The Joint Commission). Sentinel event statistics released for 2018. TJC Online 2019; March 13, 2019
TJC (The Joint Commission). Sentinel event statistics released for first 6 months of 2019 with new suicide categories. TJC Online 2019; August 14, 2019
CDPH (California Department of Public Health). Compleilnt Intake Number; CA00569261; CDPH 2019; Published June 18, 2019
CDPH (California Department of Public Health). Compleilnt Intake Number; CA00540695; CDPH 2019; Published January 16, 2019
CDPH (California Department of Public Health). Compleilnt Intake Number; CA00584143; CDPH 2019; Published January 18, 2019
NoThing Left Behind®: A National Surgical Patient Safety Project to Prevent Retained Surgical Items. Prevention of Retained Surgical Instruments
http://nothingleftbehind.org/Instruments.html
CDPH (California Department of Public Health). Event ID CA00235788
NoThing Left Behind®: A National Surgical Patient Safety Project to Prevent Retained Surgical Items
AORN (Association of periOperative Registered Nurses). Retained Surgical Items. 2018
ACS (American College of Surgeons). Revised statement on the prevention of unintentionally retained surgical items after surgery. October 1, 2016
TJC (The Joint Commission). New Sentinel Event Alert video: Preventing Unintended Retained Foreign Objects. Joint Commission Online 2017; October 25, 2017
TJC (The Joint Commission). Sentinel Event Alert. Preventing unintended retained foreign objects. Issue 51 October 17, 2013
http://www.pwrnewmedia.com/2013/joint_commission/urfo/downloads/SEA_51_URFOs.pdf
Wallace SC. PPSA (Pennsylvania Patient Safety Authority). Retained Surgical Items: Events and Guidelines Revisited. Pennsylvania Patient Safety Advisory 2017; 14(1): 27-35
http://patientsafety.pa.gov/ADVISORIES/Pages/201703_RSI.aspx
Gibbs V. 5 Keys to Preventing Retained Surgical Items. Use these strategies so there's nothing left behind. Outpatient Surgery 2019; XX(4): April 2019
Steelman VM, Shaw C, Shine L, Hardy-Fairbanks AJ. Retained surgical sponges: a descriptive study of 319 occurrences and contributing factors from 2012 to 2017. Patient Safety in Surgery 2018; 12:20 Published 29 June 2018
https://pssjournal.biomedcentral.com/articles/10.1186/s13037-018-0166-0
Steelman VM, Shah C, Shine L, et al. Unintentionally Retained Foreign Objects: A Descriptive Study of 308 Sentinel Events and Contributing Factors. Joint Commission Journal on Quality and Patient Safety 2019; 45(4): 249-258
https://www.jointcommissionjournal.com/article/S1553-7250(18)30304-0/fulltext
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August 2019
In our December 18, 2018 Patient Safety Tip of the Week “Great Recommendations for e-Prescribing” and several other columns we’ve stressed the importance of including the indication for a medication when entering a prescription or order for a medication. Providing the indication for a prescription is important for more than one reason. First, there are many medications that are used for treating multiple conditions. For example, beta blockers may be used in the treatment of MI, CHF, migraine, essential tremor, hypertension, etc. Knowing the reason for the initial prescription, thus, is important when decisions about discontinuation are being pondered.
Second, seeing the indication may help a pharmacist recognize when a wrong drug has been prescribed. That is especially important when LASA (“look-alike, sound-alike”) errors are made. For example, if a prescriber erroneously clicked on “Dilaudid” instead of “Dilantin” but a pharmacist saw the indication was “for seizures”, the pharmacist would recognize a problem and contact the prescriber for clarification. The same concept should be used at the time of order entry to prevent prescribing the wrong medication. In the example above, if you looked for “seizures” as an indication under the erroneously chosen “Dilaudid” you’d realize you had chosen the wrong drug.
Third, seeing the indication can help avoid wrong-dosing errors. For example, we’ve discussed the methotrexate problem in multiple columns. That is when methotrexate is ordered for treating an autoimmune condition, like rheumatoid arthritis, rather than for oncologic conditions. For the former, once weekly dosing is used. So, if the pharmacist saw an order for daily methotrexate and the indication was “rheumatoid arthritis”, the pharmacist might recognize the dosing error.
Over 15 years ago, when we were doing introduction to patient safety for all incoming residents in the SUNY Buffalo system, we began including a slide stressing how inclusion of indication for a medication can help reduce medication errors. We’re, of course, not the only ones calling for this simple, yet frequently overlooked, patient safety intervention. ISMP (ISMP 2010) stressed this in its guidelines for standard order sets (see our March 23, 2010 Patient Safety Tip of the Week “ISMP Guidelines for Standard Order Sets”). And Schiff et al. made a plea to incorporate indication into medication ordering in a New England Journal of Medicine piece in 2016 (Schiff 2016). And it was one of the key elements in the article by Schiff et al. (Schiff 2018) that we highlighted in our December 18, 2018 Patient Safety Tip of the Week “Great Recommendations for e-Prescribing”.
So how are we doing in getting medication indication incorporated into medication orders or prescriptions? A recent study (Salazar 2019) says not so good. Salazar et al. extracted free-text sigs from all outpatient prescriptions generated by the computerized prescriber order entry system of a major academic institution during a 5-year period. They then used natural language processing to identify drug indications. In over 4 million prescriptions, they found indications were included in only 7.41%.
77.18% of those which included the indication were written for PRN orders. Somewhat surprisingly, the highest rate of including indication was by orthopedic surgery providers (33.41%), whereas the rate for internal medicine prescribers was only 6.26%. Pain was the most common indication, accounting for 30.35% of all documented indications. Non-PRN chronic medication prescriptions rarely included the indication.
So, we’re not doing so well. Since almost all prescribing and ordering medications today is via computer (through CPOE or ePrescribing systems), the solution needs to be a technological one. Those systems need to prompt all clinicians ordering medications for the indication. They should have drop-down lists of common reasons for ordering such medications but would also need an “other” category for entering free text if the indication is something other than the common ones presented. While you always like to avoid free text entries, you might not be able to predict what the entry might be. So, there need to be alerts for identifying mistakes in that latter circumstance. For example, in the scenario we mentioned above when the clinician mistakenly orders “Dilaudid” instead of “Dilantin”, the script for an alert would have to recognize “seizures” or “epilepsy” in the free text entered under “other”. Moreover, it would have to recognize typos, so it would have to employ natural language processing or similar tool to recognize those words. In addition, all the standing order sets in your system will need to be redone to include indications for any medications included.
So, you can see a lot of work needs to be done!
And while we are talking about requiring an indication for all medications, we’d also like to take the opportunity once again to make our plea for including a “reason for discontinuation” when drugs are discontinued. It may be important to know whether a medication was discontinued because of:
For example, I might consider prescribing a beta blocker for migraine prophylaxis and the patient tells me that he/she was once on that medication. It would be important for me to know whether it had been discontinued because it was ineffective for the initial indication (other than migraine prophylaxis) or because of an untoward side effect or true allergy.
See also our August 6, 2019 Patient Safety Tip of the Week “Repeat Adverse Drug Events”.
References:
ISMP (Institute for Safe Medication Practices). Guidelines for Standard Order Sets. January 12, 2010
https://www.ismp.org/guidelines/standard-order-sets
Schiff GD, Seoane-Vazquez E, Wright A. Incorporating indications into medication ordering—time to enter the age of reason. N Engl J Med 2016; 375(4): 306-309
https://www.nejm.org/doi/full/10.1056/NEJMp1603964
Schiff G, Mirica MM, Dhavle AA, Galanter WL, et al. A Prescription For Enhancing Electronic Prescribing Safety. Health Affairs 2018; 37(11): 1877-1883
https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2018.0725
Salazar A, Karmiy SJ, Forsythe KJ, et al. How often do prescribers include indications in drug orders? Analysis of 4 million outpatient prescriptions. American Journal of Health-System Pharmacy 2019; 76(13): 970-979
https://academic.oup.com/ajhp/article-abstract/76/13/970/5519760?redirectedFrom=fulltext
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We’ve done several columns discussing the problems inpatients encounter in achieving near-normal sleep patterns and ways for you to avoid use of sleep medications (see, for example, our Patient Safety Tips of the Week for August 6, 2013 “Let Me Sleep!”, May 15, 2018 “Helping Inpatients Sleep”, and November 6, 2018 “More on Promoting Sleep in Inpatients”).
There have been two recent good resources to help you avoid these in your inpatients.
Soong and colleagues published an implementation guide to promote sleep and reduce sedative-hypnotic initiation for noncritically ill inpatients (Soong 2019). They conducted a review summarizing effective interventions aimed at promoting sleep and reducing inappropriate sedative-hypnotic initiation. They then proposed an implementation strategy to guide quality improvement teams.
Many studies had described implementation of sleep hygiene protocols to reduce sedative-hypnotic use. Such have addressed modifiable factors associated with sleep disruption, reinforced premorbid healthy sleep habits and circadian rhythms, and promoted relaxation without pharmacologic means (examples: reduction of noise and light, modifying clinical monitoring and medication administration schedules where appropriate to maximize uninterrupted sleep time, and assisting patients with bedtime routines and relaxation techniques).
A second common approach involved structured medication reviews conducted by pharmacists. Soong et al. note studies showing successful reduction of sedative/hypnotic drugs when these programs are employed in acute care or long-term care settings.
Simple audit and feedback has been successful in reducing ordering of sleep meds in several studies. Computer-based interventions, like alerts and reminders have also been successful in a few studies. These work best not only when combined with educational information but also when they include suggestions for alternative non-pharmacologic interventions to promote natural sleep.
They did also include educational interventions, including counter-detailing, but results have been mixed. While we don’t discourage such educational endeavors, we recognize that education is one of the weakest interventions we do for almost any patient safety problem.
The authors go on to suggest several strategies to guide quality improvement initiatives to actively de-adopt sedative-hypnotic use for sleep use among inpatients.
Strategy 1: Create a Sleep-Promoting Inpatient Environment
A multidisciplinary team needs to help create such an environment using concepts like designated overnight periods of reduced noise, lighting, and interruptions for unnecessary clinical monitoring or nonessential medication administration. See our November 6, 2018 Patient Safety Tip of the Week “More on Promoting Sleep in Inpatients” for multiple examples of such programs.
Strategy 2: Interventions Targeting Prescribers
These include pharmacist-enabled medication reviews to flag new prescriptions, computer-based interventions, performance data feedback, and education. They also stress the role that nurses and nurse practitioners may have in promoting non-pharmacologic interventions.
Strategy 3: Rigorous Evaluation of Interventions
Like any good quality improvement program, these programs need to employ measurement to ensure that the goals of the programs are being met. These should include evaluation of not only sedative/hypnotic use but also clinical and patient-reported outcomes such as falls, delirium, and sleep quality.
The second recent contribution was publication of results of a sedative reduction bundle implemented among medical and cardiology inpatients (Fan-Lun 2019). They had analyzed data at their institution and found that over 15% of hospitalized older adults were prescribed sedative-hypnotics inappropriately. Of those prescriptions, 87% occurred at night to treat insomnia and almost 20% came from standard admission order sets. So, they implemented a multi-modal “bundle” to address the problem.
The bundle consisted of education, removal of benzodiazepines and sedative hypnotics from available admission order sets, and use of non-pharmacological strategies to improve sleep. From the mean baseline benzodiazepine and sedative/hypnotic prescription rate of 15.8%, the postintervention period saw an absolute reduction of 8.0%. Adjusted for temporal trends, the intervention produced a 5.3% absolute reduction in the proportion of patients newly prescribed benzodiazepines and sedative hypnotics. Prescription rates on the control ward remained stable. There was no change in the patient-reported measure of sleep quality, falls, and use of other sedating medications throughout the study duration.
Some of our previous columns on safety issues associated with sleep meds and promoting sleep in inpatients:
August 2009 “Bold Experiment: Hospitals Saying No to Sleep Meds”
March 23, 2010 “ISMP Guidelines for Standard Order Sets”
May 2012 “Safety of Hypnotic Drugs”
November 2012 “More on Safety of Sleep Meds”
March 2013 “Sedative/Hypnotics and Falls”
June 2013 “Zolpidem and Emergency Room Visits”
August 6, 2013 “Let Me Sleep!”
June 3, 2014 “More on the Risk of Sedative/Hypnotics”
May 15, 2018 “Helping Inpatients Sleep”
June 2018 “Deprescribing Benzodiazepine Receptor Agonists”
November 6, 2018 “More on Promoting Sleep in Inpatients”
June 2019 “FDA Boxed Warning on Sleep Meds”
References:
Soong C, Burry L, Cho HJ, et al. An Implementation Guide to Promote Sleep and Reduce Sedative-Hypnotic Initiation for Noncritically Ill Inpatients. JAMA Intern Med 2019; 179(7): 965-972 Published online June 03, 2019
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2734633
Fan-Lun C, Chung C, Lee EHG, et al. Reducing unnecessary sedative-hypnotic use among hospitalised older adults. BMJ Quality & Safety 2019; Published Online First: 03 July 2019
https://qualitysafety.bmj.com/content/early/2019/07/02/bmjqs-2018-009241
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The 1999 Institute of Medicine (IOM) report “To Err is Human: Building a Safer Health System” has widely been recognized as opening the eyes of the public and the medical profession about the enormity of the issue of medical errors. It estimated that up to 98,000 patients might die each year as the result of their medical care rather than from their underlying medical conditions. While some criticized the study as overestimating the numbers or noted many of the patients may have died anyway, most of us who have been hospital medical directors or been involved in quality improvement and patient safety felt the numbers were likely underestimates.
Since then there have been numerous studies looking at the frequency of medical errors, but most have focused on total errors rather than those errors that are truly preventable.
A new systematic review and meta-analysis in the BMJ concludes that around one in 20 patients are exposed to preventable harm in medical care (Panagioti 2019). Moreover, 12% of such cases result in permanent disability or death.
The authors reviewed 70 studies, with over 300,000 patients, that reported on preventable harm. The pooled prevalence for preventable patient harm was 6%. And the pooled prevalence of overall harm (preventable and non-preventable) was 12%. A pooled proportion of 12% of preventable patient harm was severe or led to death. The highest percentage of incidents with preventable harm were related to drugs (25%) and other treatments (24%), followed by surgical procedures (23%), healthcare infections (16%,), and diagnosis (16%).
Since the authors found preventable patient harm occurs in 6% of patients across medical care settings and the pooled prevalence of overall harm was 12%, the authors conclude that half of patient harm is preventable.
Compared with general hospitals (where most evidence originated), preventable patient harm was more prevalent in advanced specialties (intensive care or surgery). The highest pooled prevalence estimate of preventable patient harm was reported in intensive care (18%) and surgery (10%) and the lowest in obstetrics (2%).
In addition to the human costs, the authors note that preventable harm results in about $9.3 billion in extra health care costs in the United States. That comes from a study by Zhan et al. (Zhan 2003) which studied excess length of stay, charges, and mortality attributable to medical injuries during hospitalization. From their data, they extrapolated to infer that the 18 types of medical injuries studied may add to a total of 2.4 million extra days of hospitalization, $9.3 billion excess charges, and 32,591 attributable deaths in the United States annually.
Two accompanying editorials (Abbasi 2019, Papanicolas 2019) discuss the heterogeneity of definitions of preventable harm across studies and call for better measures of preventable harm.
In an upcoming column we will discuss the recent analysis by the Betsy Lehman Center for Patient Safety in Massachusetts of the financial costs of medical errors and the behavioral, physical, emotional, and financial harms to those who suffered the errors (Betsy Lehman Center 2019). Overall, they identified almost 62,000 preventable harm events that resulted in over $617 million in excess health care insurance claims. That accounts for about 1% of the total Massachusetts expenditures on healthcare in 2017.
Landrigan et al (Landrigan 2010) found lethal adverse events due to medical errors in 0.6% of hospital admissions in North Carolina hospitals, 63.1% of which were deemed to be preventable.
Other studies put the estimates for patient harm resulting from healthcare at much higher rates. In our May 2011 What’s New in the Patient Safety World column “Just How Frequent Are Hospital Medical Errors?” we noted a study (Classen 2011), using IHI’s Global Trigger Tool to identify hospital adverse events, that found that the numbers may be 10-fold higher than what was noted in the IOM report. Potentially avoidable adverse events occurred in a third of hospital admissions. Another study by Levinson (Levinson 2012) found that hospital incident reporting systems do not capture most patient harm.
James (James 2013) utilized the Global Trigger Tool (GTT) methodology to identify cases of potentially preventable medical errors. Using a weighted average of 4 studies utilizing the GTT, he estimated that the lower limit of deaths per year associated with preventable harms in hospitals is 210,000 deaths per year. And, given the limitations of the GTT and fact that these studies did not include deaths related to diagnostic errors which may not show up for years, he further estimated that the number of deaths associated with preventable harm may be more than 400,000 per year. He also noted that the frequency of serious harm may be 10- to 20-fold higher than that for lethal harm.
Makary and Daniel (Makary 2016) declared medical errors as the third leading cause of death in the US but pointed out the great difficulties in accurately measuring this problem.
How dangerous is a day in the hospital? For many years, we have used the numbers from a study done by Lori Andrews et al. (Andrews 1997) that found you have a 6% chance per inpatient day of having an adverse event that could impact your health. And, of course, a 2010 report (Levinson 2010) showed that one in every seven Medicare patients who is hospitalized experienced adverse events during their hospital stays, up to 44% being potentially preventable. A study (Hauck 2011) quantified the risk even further. Using a large database from public hospitals in Australia, the authors calculated that the average hospital stay carries a 5.5% risk of adverse drug reaction, 17.6% risk of infection, and 3.1% risk of pressure ulcers. Moreover, each additional night in the hospital increases the risk by 0.5% for adverse drug reactions, 1.6% for infections, and 0.5% for pressure ulcers.
So, got all those numbers? You’ll forget them shortly. You’ve often heard us use the phrase “Stories, Not Statistics” (see our December 2009 What’s New in the Patient Safety World column “Stories, Not Statistics”). When we first began doing presentations on patient safety in the early 1990’s we often began with some of the statistics on medical error from Lucien Leape’s work. But we began to notice physicians and medical students begin to zone out when we talked about statistics on medical error. What got their attention were the anecdotes we would tell about cases that really happened. So, we changed our focus. While we still often show statistics on medical error to put things in context, we no longer highlight them. Instead, we really rely on the stories. That’s what makes people say “I wonder if that could happen here?” and what makes them go back to look at the systems in their health care systems. It is those stories that hit home hard and make people remember. Who cannot remember their own reactions when they first heard the Josie King story, or the story about the nurse who administered Bicillin intravascularly, or the little boy who died from concentrated epinephrine injection during a simple surgical procedure, or any nurse who inadvertently administered concentrated potassium solutions?
In fact, the lack of compelling stories like these is the prime reason we feel IOM’s “To Err is Human: Building a Safer Health System” failed to gain traction despite considerable initial media attention. Everyone focused on the statistics from that report. It lacked the stories about real people you need to tell in order to get people and systems to change.
The new Panagioti study will undoubtedly suffer the same fate. Yes, it does reinforce the magnitude of the problem. But telling stories about real people experiencing such problems is what will get your healthcare colleagues to perk up and take notice that many of those problems could happen in their hospital or their practice.
See some of our prior columns on the frequency of harmful medical errors:
May 2011 “Just How Frequent Are Hospital Medical Errors?”
February 2012 “OIG: Hospitals Fail to Recognize Most Cases of Harm”
March 2012 “How Dangerous is a Day in the Hospital?”
October 2013 “How Many Deaths Result from Medical Errors?”
References:
Institute of Medicine. To Err is Human: Building a Safer Health System. Washington, DC: National Academy Press, 1999
https://www.ncbi.nlm.nih.gov/books/NBK225182/
Panagioti M, Khan K, Keers RN, et al. Prevalence, severity, and nature of preventable patient harm across medical care settings: systematic review and meta-analysis. BMJ 2019; 36: l4185
https://www.bmj.com/content/366/bmj.l4185
Zhan C, Miller MR. Excess length of stay, charges, and mortality attributable to medical injuries during hospitalization. JAMA 2003; 290: 1868-1874
https://jamanetwork.com/journals/jama/fullarticle/197442
Abbasi K. First do no harm: the impossible oath. BMJ 2019; 366: l4734
https://www.bmj.com/content/366/bmj.l4734
Papanicolas I, Figueroa JF. Preventable harm: getting the measure right. BMJ 2019; 366 : l4611
https://www.bmj.com/content/366/bmj.l4611
Betsy Lehman Center for Patient Safety. The Financial and Human Cost of Medical Error... and how Massachusetts can lead the way on patient safety. Betsy Lehman Center 2019; June 2019
https://www.betsylehmancenterma.gov/research/costofme
Landrigan CP, Parry GJ, Bones CB, et al. Temporal Trends in Rates of Patient Harm Resulting from Medical Care. N Engl J Med 2010; 363: 2124-2134
http://www.nejm.org/doi/full/10.1056/NEJMsa1004404
Classen D, Resar R, Griffin F, et al. ‘Global Trigger Tool’ Shows That Adverse Events In Hospitals May Be Ten Times Greater Than Previously Measured. Health Affairs 2011; 30(4): 581-589
http://content.healthaffairs.org/content/30/4/581.abstract
Levinson DR. OIG (Office of the Inspector General. Department of Health and Human Services). Hospital Incident Reporting Systems Do Not Capture Most Patient Harm. January 2012
https://oig.hhs.gov/oei/reports/oei-06-09-00091.pdf
James JT. A New, Evidence-based Estimate of Patient Harms Associated with Hospital Care. Journal of Patient Safety 2013; 9(3): 122–128
Makary MA, Daniel M. Medical error-the third leading cause of death in the US. BMJ 2016; 353: i2139
Andrews LB, Stocking C, Krizek T, et al. An alternative strategy for studying adverse events in medical care. Lancet 1997; 349: 309–313
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2896%2908268-2/fulltext
Levinson DR. Adverse Events in Hospitals: National Incidence Among Medicare Beneficiaries. Washington, DC: US Department of Health and Human Services, Office of the Inspector General; November 2010. Report No. OEI-06-09-00090
https://oig.hhs.gov/oei/reports/oei-06-09-00090.pdf
Hauck K, Zhao X. How Dangerous is a Day in Hospital?: A Model of Adverse Events and Length of Stay for Medical Inpatients. Medical Care 2011; 49(12): 1068-1075, December 2011
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Our July 2012 What’s New in the Patient Safety World column “A Culture of Disrespect” summarized what Lucian Leape considers to be the number one problem in patient safety today: we have a culture of disrespect. Leape noted that the problem is not just that of the obvious disruptive physician who yells at people, throws things, etc. Rather, there are much more subtle behaviors that are equally disrespectful, and all are threats to teamwork and patient safety.
Then, in our September 22, 2015 Patient Safety Tip of the Week “The Cost of Being Rude”, we highlighted a study by Riskin et al. (Riskin 2015).that demonstrated the negative impact of rudeness on diagnostic and procedural performance in a very clever randomized controlled trial in a simulated environment.
Once again, Riskin et al. (Riskin 2019) conducted a study of primarily nurses in a general hospital which explored the impact of rudeness on patient safety performance, “state depletion” (that is, exhaustion of mental energy for reflective behavior), and team processes (for example, information sharing). A total of 231 rudeness incidents were reported in 98 shifts (out of 480 shifts analyzed). Most rudeness incidents stemmed from a patient or family. After a rudeness exposure, compliance with hand hygiene was significantly lower (for up to 24 hours following the exposure). Rudeness also led to decreased information sharing and increased team member’s state depletion. The adverse indirect effect of shifts’ temporal proximity to rudeness on poor compliance with medication preparation and team members’ information sharing via state depletion was significant. Rudeness exposure was also associated with increased rate of adverse events in the subsequent 24 hours, although this association was not statistically significant.
Another recent study in a simulated operating room scenario demonstrated that incivility had a negative impact on performance (Katz 2019). Katz et al. randomly assigned anesthesiology residents to either a normal or ‘rude’ environment and subjected them to a validated simulated operating room crisis. The “rude” environment included an impatient surgeon-actor in a simulated OR hemorrhage scenario. They measured both technical and non-technical performance domains including vigilance, diagnosis, communication and patient management. Those exposed to incivility scored lower on every performance metric, including a binary measurement of overall performance with 91.2% (control) versus 63.6% (rude) obtaining a passing score (p=0.009). It was particularly stroking that multiple areas were impacted including vigilance, diagnosis, communication and patient management even though participants were not aware of these effects (self-reported performance assessment was similar between groups).
They note that incivility doesn’t have to mean ranting and raving behavior. It can involve much more subtle behaviors, such as failure to use someone’s name (instead, calling them out by their function). You’ll recall from our July 2012 What’s New in the Patient Safety World column “A Culture of Disrespect” that Lucian Leape had also stressed the more subtle ways that disrespect is conveyed. Indeed, a new study (Torres 2019) shows that “microaggressions” in medicine and surgery can create stresses that are worse than those caused by overt behaviors. Microaggressions are subtle forms of prejudice and discrimination. The authors categorize them as microassaults, microinsults, microinvalidations, and environmental microaggressions. Examples include slights, humiliation, snubs, dismissals, general disrespect, devaluation, and exclusion. Microaggressions are often directed at minorities and women. The authors go on to describe ways to recognize microaggressions and how to respond to them.
And yet recent another study (Cooper 2019) found that patients whose surgeons had higher numbers of coworker reports about unprofessional behavior in the 36 months before the patient’s operation appeared to be at increased risk of surgical and medical complications. The researchers were able to use data from medical centers that participated in the National Surgical Quality Improvement Program (NSQIP) and recorded and acted on electronic reports of safety events from coworkers describing unprofessional behavior by surgeons. The adjusted complication rate was 14.3% higher for patients whose surgeons had 1 to 3 reports and 11.9% higher for patients whose surgeons had 4 or more reports compared with patients whose surgeons had no coworker reports. Despite the higher complication rate for surgeons with more reports, there was no difference between groups for mortality, need for second operations, or readmission within 30 days.
In the accompanying editorial Emerel et al. (Emerel 2019) use the analogy to the #MeToo movement to make the point we can no longer tolerate workplace hostility. Hospitals can no longer “look the other way” and let unprofessional behavior go unaddressed. Medicine and surgery, in particular, is a “team sport” and any negative interactions within the team can lead not only to poor team function, turnover, and burnout, but also to poor patient outcomes.
Some of our prior columns on the impact of “bad behavior” of healthcare workers:
January 2011 “No Improvement in Patient Safety: Why Not?”
March 29, 2011 “The Silent Treatment: A Dose of Reality”
July 2012 “A Culture of Disrespect”
July 2013 “"Bad Apples" Back In?”
July 7, 2015 “Medical Staff Risk Issues”
September 22, 2015 “The Cost of Being Rude”
April 2017 “Relation of Complaints about Physicians to Outcomes”
October 2, 2018 “Speaking Up About Disruptive Behavior”
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”
May 2016 “ECRI Institute’s Top Ten Patient Safety Concerns for 2016”
June 28, 2016 “Culture of Safety and Catheter-Associated Infections”
April 2017 “Relation of Complaints about Physicians to Outcomes”
April 2017 “Joint Commission Sentinel Event Alert on Safety Culture”
October 2, 2018 “Speaking Up About Disruptive Behavior”
References:
Riskin A, Erez A, Foulk TA, et al. The Impact of Rudeness on Medical Team Performance: A Randomized Trial. Pediatrics 2015; 136: 487-495
http://pediatrics.aappublications.org/content/136/3/487.abstract
Riskin A, Bamberger P, Erez A, et al. Incivility and Patient Safety: A Longitudinal Study of Rudeness, Protocol Compliance, and Adverse Events. Joint Commission Journal on Quality and Patient Safety 2019; 45(5): 358-367
https://www.jointcommissionjournal.com/article/S1553-7250(18)30403-3/fulltext
Katz D, Blasius K, Isaak R, et al. Exposure to incivility hinders clinical performance in a simulated operative crisis. BMJ Quality & Safety Published Online First: 31 May 2019
https://qualitysafety.bmj.com/content/early/2019/05/31/bmjqs-2019-009598
Torres MB, Salles A, Cochran A. Recognizing and Reacting to Microaggressions in Medicine and Surgery. JAMA Surg. Published online July 10, 2019
https://jamanetwork.com/journals/jamasurgery/article-abstract/2738043
Cooper WO, Spain DA, Guillamondegui O, et al. Association of Coworker Reports About Unprofessional Behavior by Surgeons With Surgical Complications in Their Patients. JAMA Surg 2019; Published online June 19, 2019
Emerel LV, Kent T, Chu D. Time for Changes in the Surgical Community—Promoting Professionalism as #MeToo 2.0. JAMA Surg. Published online June 19, 2019
https://jamanetwork.com/journals/jamasurgery/article-abstract/2736332
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