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July 3, 2012
Recycling an Old Column: Dilaudid Dangers
We had planned to be on vacation this week and next week. But a safety bulletin just put out by ISMP Canada on HYDROmorphone (ISMP Canada 2012a) suggested to us that we might recycle one of our most popular previous columns (September 21, 2010 Patient Safety Tip of the Week Dilaudid Dangers).
ISMP Canada had done a nationwide survey on knowledge about a variety of things related to HYDROmorphone because that drug was one of the top 3 drugs reported to ISMP Canada as causing harm. Their analysis of those reports strongly suggested gaps in provider knowledge, particularly in relation to dose potency compared to morphine and other opioids.
There were almost 3500 respondents to the survey (nurses, pharmacists, and physicians). The findings are summarized in the ISMP Canada Safety Bulletin (ISMP Canada 2012a) and the full survey results with questions, actual responses, and correct answers also provides additional analysis (ISMP Canada 2012b). While 88% of respondents correctly identified the relative potency of HYDROmorphone compared to morphine, those responses may have been influenced by an associated webinar that presented such information. There were especially knowledge gaps on differences in potencies of HYDROmorphone in various preparations (eg. oral vs. parenteral vs. subcutaneous) and gaps regarding the various slow-release forms.
Some gaps in knowledge were also noted regarding the concepts of patients being either opioid-naive or opioid-tolerant.
The biggest gaps in knowledge about HYDROmorphone appeared to be related to the pharmacological aspects. In particular, knowledge appeared to be limited regarding the duration of action of the various forms of HYDROmorphone and their relationship to the duration of action of naloxone. That, of course, is relevant to the phenomenon of renarcotization in which the reversal effect of the narcotic antagonist disappears while there is still substantial opioid on board.
Also, there were gaps in knowledge regarding dosing of HYDROmorphone in patients with various comorbidities. Many respondents incorrectly thought that higher doses were needed in obese patients. Many also did not understand that lower doses should be used in patients with COPD, obstructive sleep apnea, the elderly, and those taking benzodiazepines.
They also identified knowledge gaps related to the HYDROmorphone medication use process, particularly related to the proper steps for verifying orders, doing dose calculations, and programming IV pumps.
ISMP Canada. Identifying Knowledge Deficits Related to HYDROmorphone. ISMP Canada Safety Bulletin 2012; 12(7): 1-4 June 27, 2012
ISMP Canada. Report to Health Canada. Hydromorphone Knowledge Assessment
Survey Results. April 2012
Also recall that the FDA recently recommended altered labeling for HYDROmorphone (see our November 2011 Whats New in the Patient Safety World column FDA Changes on Dilaudid/HYDROmorphone). The new labeling has some changes in format designed to bring to the attention of the prescriber some important aspects of using HYDROmorphone. But probably the two most important changes have to do with specific dosing issues:
1) The recommended intravenous starting dose is reduced to 0.2-1 mg (previously it was 1-2 mg)
2) A bolded warning notes that morphine and HYDROmorphone are not milligram-to-milligram conversion equivalents and they provide a conversion table for converting doses of other opioids to HYDROmorphone
So we hope youll read the 2 ISMP Canada documents. Take time to read all the questions and correct answers in the full survey document. We learned a lot from them. Then read our previous column:
September 21, 2010 Dilaudid Dangers
One of the topics we seem to keep returning to is respiratory depression due to intravenous opioids. Our most recent column was our July 13, 2010 Patient Safety Tip of the Week Postoperative Opioid-Induced Respiratory Depression, in which we highlighted the inherent difficulties in monitoring patients on intravenous opioids.
While all opioids may cause respiratory depression, we have always been surprised that Dilaudid (HYDROmorphone) seems to pop up as a cause in a disproportionate number of cases. Were not the only ones! Some recent published reports seem to have come to that same conclusion. About a year ago The Doctors Company (Marcus 2009) published several cases from their claims database that highlighted some of the lessons learned in cases of Dilaudid-induced respiratory depression. And the Pennsylvania Patient Safety Authority (PPSA 2010) just highlighted issues with hydromorphone in their most recent Patient Safety Advisory.
But problems with Dilaudid are not new. ISMP Canada (ISMP Canada 2006) noted that Dilaudid ranked third on their list of drugs most frequently reported as causing harm. They found that 9.3% of all their reported cases of medications causing harm or death were attributed to Dilaudid.
The Doctors Company paper cites several cases of fatalities or serious neurological damage in patients where Dilaudid contributed to respiratory depression. They cite a number of reasons for this adverse consequence. First and foremost is the issue of improper dosage. Most physicians and nurses dont realize how potent Dilaudid is on a mg to mg basis compared to morphine sulfate. While estimates of equipotency vary considerably in the literature, most now agree that 1 mg. of Dilaudid is probably the equivalent of 7 mg. of morphine. Chang and colleagues (Chang 2010) had noted several years ago that emergency room physicians and nurses who were hesitant to administer 7 to 10 mg. of morphine were not reluctant to administer 1 to 1.5 mg. of Dilaudid. They point out this is an illusion that less narcotic is being used with that Dilaudid dose.
Ironically, Dilaudids problems may be an unintended consequence of a patient safety initiative taken by most facilities. Demerol (meperidine) was removed from many formularies a number of years ago because a toxic metabolite was causing significant untoward effects. It was replaced in most cases by Dilaudid and most healthcare workers were much less familiar with Dilaudid.
The look-alike/sound-alike (LASA) issue obviously also pops up, in which hydromorphone and morphine are mixed up. In fact, this is said to be one of the most frequent drug pairs involved in LASA errors. Use of tall man lettering (HYDROmorphone) is advised but, frankly, many healthcare workers still mistakenly assume that HYDROmorphone is an equipotent form of morphine. An outstanding published RCA (root cause analysis) done by ISMP Canada on a fatal Dilaudid overdose highlighted not only the fact that hydromorphone sounds like morphine but at that time also came in packaging that looked similar to that for morphine. Note that even the tall man lettering standard for Dilaudid has been controversial. At one time hydromorPHONE was used. But in response to an ISMP survey done in 2007, the standard was changed to the currently used HYDROmorphone.
The recent Pennsylvania Patient Safety Advisory noted over 1600 reports of medication errors related to hydromorphone in a period of less than two years (PPSA 2010). Of these, 1.8% resulted in patient harm. They highlighted wrong dose errors, wrong drug errors, and monitoring errors and noted problems in the prescribing, dispensing and administration phases of medication safety. They offer numerous recommendations to improve safety when using hydromorphone.
In many of the cases in the Doctors Company paper the patients also received other agents (sedative/hypnotic drugs) capable of potentiating the respiratory depressant effects of Dilaudid. And beware when using supplemental oxygen in such patients. Not only does supplemental oxygen render pulse oximetry less reliable in detecting early respiratory depression but it may also contribute to depression of respiration in patients prone to hypercapnia (see our Patient Safety Tips of the Week for April 8, 2008 Oxygen as a Medication, June 10, 2008 Monitoring the Postoperative COPD Patient, and January 27, 2009 Oxygen Therapy: Everything You Wanted to Know and More!). In such patients who are at risk for hypercapnia, using lower oxygen saturation targets may be indicated.
The ISMP Canada study noted that mixups between hydromorphone and morphine were the most common substitution errors in their analysis. They especially noted that availability of higher-concentration vials of hydromorphone (10 mg/mL) seemed to increase the likelihood of confusion with morphine. And while they noted that unfamiliarity with appropriate dosages of hydromorphone were the most common reason for incorrect doses, they also cited poor communication of orders (eg. verbal, telephone or written), lack of a preceding 0 before decimal points, and cognitive lapses as contributing factors. Errors in programming infusion pumps were frequent causes of harm. And they noted that the monitoring protocols typically used are often inadequate in high risk patients. We will focus on that latter point later because the problems we have encountered with Dilaudid have occurred most frequently in such high risk patients (eg. those with morbid obesity and /or sleep apnea).
Double checks are often recommended when we are dealing with administration of high-risk medications. Even though we have emphasized that double checks are a relatively weak intervention (we know from all industries that the error rate when a supervisor checks someone elses work may be 10% or higher), the literature supports a medication error reduction of about 30% when using a double check system (see our July 15, 2008 Patient Safety Tip of the Week Heparin Flushes.....Again!). Also, for any high-risk medications you need to do truly independent double checks (see our March 30, 2010 Patient Safety Tip of the Week Publicly Released RCAs: Everyone Learns from Them for a description of independent double checks). Another nice article on independent double checks in preventing medication errors (ISMP Canada 2005) describes the independent double check process and calculates that independent double checks would reduce the error rate of a process having an error rate of 5% all the way down to 1 in 400.
A large number of claims and settlements in anesthesiology cases involving postoperative care had respiratory depression secondary to opioid analgesics as a central issue (Bird 2001). Many of the reported cases have occurred in patients with known sleep apnea or with suspected sleep apnea and morbid obesity. Sleep apnea patients are vulnerable to the respiratory depressant effects of opioids and there often seems to be a disproportionate effect on respiration compared to depression of the level of arousal.
In a well-done FMEA on PCA therapy, Moss (Moss 2010) also highlighted some of the problems noted above. She noted that, as in most facilities, Dilaudid had replaced Demerol in the formularies but that most physicians and nurses and pharmacists had much less experience with Dilaudid than with Demerol. That group then made use of standardized order sets to help reduce the errors. A second key vulnerability point they identified was patient selection. Patients using PCA must have both cognitive and physical capabilities to operate the pumps. However, at-risk patients (for PCA using any opioid) are those at the extremes of age, those with COPD, end-stage renal disease, and especially obesity and sleep apnea. They emphasized the need for careful monitoring with pulse oximetry and capnography if PCA is to be used in such patients.
The Anesthesia Patient Safety Foundation (APSF) in 2006 held a workshop focusing on postoperative opioid therapy and respiratory depression (Weinger 2007). They emphasized the risk of respiratory depression occurs with patient controlled analgesia (PCA), neuraxial opioid anesthesia, and intermittent dosing of opioids. And their findings and recommendations obviously apply not to just postoperative settings but to any time such opioid therapy is being used. While they recognize that current fiscal realities and limitations of monitoring technologies might limit special monitoring to high risk patients, they readily point out that you cannot always identify high risk patients (eg. many OSA patients are undiagnosed) and that even young healthy patients may suffer respiratory depression from opioid therapy. Their recommendations therefore are for continuous monitoring of patients on such opioid therapy, using continuous pulse oximetry plus capnography or other advanced technologies. But they also emphasize the importance of having a system that leads to timely responses to changes detected by such monitoring systems so that a healthcare professional capable of appropriate management is summoned to the bedside rapidly.
In our experience, monitoring patients on intravenous opioids has been the most problematic area. Others have also noted that monitoring is critical to preventing patient harm. Studies looking at malpractice claims noted that over half of respiratory events in patients on central neuraxial narcotics and almost three-quarters of those on PCA were potentially preventable using better monitoring (Weinger 2007). All such patients need to be monitored both for efficacy of pain treatment and for dangerous side effects. As such, in addition to the typical visual analog scale pain measurement (1 to 10) patients should also have their level of arousal assessed by a validated tool such as the Richmond Agitation Sedation Scale (RASS) or equivalent. And, of course, they need their vital signs monitored, including continuous monitoring of oxygen saturation by pulse oximetry. Keep in mind that pulse oximetry may provide a false sense of security, particularly when patients are on supplemental oxygen. You can have significant hypercapnia when your saO2 is still in the normal range. For high risk patients we therefore also recommend capnography.
There are several caveats about monitoring. Most importantly, when you arouse a patient who is oversedated with opioids they may, in fact, appear to be breathing at a normal rate and be able to respond appropriately to questions. Therefore, observing the patient before you stimulate them is extremely important. Anecdotally, there are also many reports of patients having respiratory depression at times when their level of arousal appears to be reasonably normal. And respiratory rate is a notoriously poor predictor of opioid-induced respiratory depression. The respiratory rate may be normal despite significant hypoventilation. Also mentioned anecdotally (Weinger 2007) is that changes in patient status may take place very rapidly and not be detected by conventional monitoring techniques used in most settings today.
Just as important is having in place a system to ensure the monitoring actually takes place. While your nursing plans of care may include all the above elements in a pain management module, youd be surprised at how often various elements are omitted. We therefore recommend that you use some sort of forcing function to ensure they are done. For example, you could program your bedside medication verification (barcoding) system to require input of the RASS before a opioid medication may be given. Or you could require the RASS score be entered into your automated dispensing cabinet (ADC) before a nurse can take the opioid out of the ADC. You should also periodically audit compliance with your pain management monitoring.
Then clearly tie your monitoring process to the administration of opioid doses. You need clearcut instructions on withholding doses or contacting the physician when the RASS score is above certain levels or when monitoring of vital signs or saO2 or capnography demonstrates abnormalities or trends. In our June 10, 2008 Patient Safety Tip of the Week Monitoring the Postoperative COPD Patient we noted a simple system used by our colleagues in the field of pain management. (Pasero and McCaffery 2002):
S = Sleep, easy to arouse (acceptable; no action necessary)
1 = Awake and alert (acceptable; no action necessary)
2 = Slightly drowsy, easily arousable (acceptable; no action necessary)
3 = Frequently drowsy, arousable, drifts off to sleep during conversation (unacceptable; decrease opioid dose by 25-50%, add an opioid-sparing analgesic, and monitor the patients level of sedation and respiratory status closely)
4 = Somnolent, minimal or no response to physical stimulation (unacceptable; stop opioid, consider administering naloxone)
The above stresses assessing the level of arousal before administering the next dose of the opioid. Addressing the level of arousal after a dose may be equally important. One hospital system (Marcus 2009) implemented a system of checking level of arousal 15-30 minutes after a Dilaudid dose.
Where your patients should be monitored is another issue you need to address. The dangers in the postoperative patient on the general medical floors compared to ICUs have been stressed, noting that preventable cardiopulmonary arrests are 5 times more likely on general medical floors (Overdyk 2010). We recommend that at least for high-risk patients you consider monitoring them in an ICU setting.
We are also advocates of keeping a cumulative dose record readily available for opioids administered. Unfortunately, there is no evidence base available to guide how you use such cumulative dose records. However, the mere fact that such would pop up may be an alert that the patient might be at risk of excessive opioid use.
And you need in place protocols whereby nursing may administer narcotic antagonists such as naloxone without having to first call a physician. Keep in mind we have previously seen cases of acute narcotic withdrawal precipitated by administration of Narcan (see our February 26, 2007 Patient Safety Tip of the Week Unintended Consequences) but those have usually occurred in patients on long-standing narcotics and, on the whole, the risk of not administering Narcan typically outweighs the very small risk of precipitating withdrawal. Also keep in mind the risk of renarcotization that may occur when there are disparities between the half life of the opioid and the half life of naloxone (see our July 13, 2010 Patient Safety Tip of the Week Postoperative Opioid-Induced Respiratory Depression). That Tip of the Week also contains a discussion of the nuances of monitoring the patient on IV opioids.
Here are some strategies you should consider to reduce the risk of Dilaudid (and other opioid) adverse events:
And dont forget these standard medication safety considerations:
Weve done several other columns on postoperative respiratory depression related to opioid administration (see our Patient Safety Tips of the Week for June 10, 2008 Monitoring the Postoperative COPD Patient, May 12, 2009 Errors With PCA Pumps, and August 18, 2009 Obstructive Sleep Apnea in the Perioperative Period.).
Opioid analgesics have been very useful in the management of acute pain and postoperative pain and there has been a push in recent years to ensure adequate pain management in all hospitalized patients. Just be wary of the potential complications and be both vigilant for their occurrence and be prepared to deal appropriately with those complications that arise.
Opioids are one of your high-alert medications. How they are used and monitored in your facility is another excellent topic for a FMEA (failure mode and effects analysis).
Other Patient Safety Tips of the Week pertaining to opioid-induced respiratory depression and PCA safety:
Marcus H. Dilaudid-Related Morbidity and Mortality from Respiratory Depression. The Doctors Company. The Doctors Advocate. Third Quarter 2009.
Pennsylvania Patient Safety Authority. Adverse Drug Events with HYDROmorphone: How Preventable are They? Pa Patient Saf Advis 2010 Sep;7(3):69-75
ISMP Canada. Shared Learning Reported Incidents Involving Hydromorphone. ISMP Canada Safety Bulletin. December 28, 2006
Chang AK, Bijur PE, Meyer RH, et al. Safety and Efficacy of Hydromorphone as an Analgesic Alternative to Morphine in Acute Pain: A Randomized Clinical Trial.
Ann Emerg Med 2006; 48: 164-172
ISMP Canada. Event Analysis Report: Hydromorphone/Morphine Event - Red Deer Regional Hospital. Red Deer, Alberta. 2004
ISMP Canada. Lowering the Risk of Medication Errors: Independent Double Checks. ISMP Canada Safety Bulletin. January 2005
Bird M : Acute Pain Management: A New Area of Liability for Anesthesiologist. ASA
Newsletter 71(8), 2007
Moss J. Reducing Errors During Patient-Controlled Analgesia Therapy Through Failure Mode and Effects Analysis. The Joint Commission Journal on Quality and Patient Safety 2010; 36(8): 359-364
Weinger MB. Dangers of Postoperative Opioids. APSF Workshop and White Paper Address Prevention of Postoperative Respiratory Complications. APSF Newsletter 2007; 21(4): 61, 63-67
Pasero C, McCaffery M. Monitoring Sedation: It's the key to preventing opioid-induced respiratory depression. American Journal of Nursing. 2002; 102(2):67-69
Overdyk, Frank J. Postoperative Opioids Remain a Serious Patient Safety Threat.
Anesthesiology. 113(1): 259-260, July 2010
July 17, 2012
More on Wrong-Patient CPOE
Last month we discussed entering orders on the wrong patient during CPOE (see our June 26, 2012 Patient Safety Tip of the Week Using Patient Photos to Reduce CPOE Errors). That column highlighted an intervention developed by Childrens Hospital of Colorado (Hyman 2012) in which a patient verification prompt accompanied by photos of the patient reduced the frequency of wrong patient order entry errors.
When we were involved in a CPOE implementation in 2008 we speculated that wrong patient errors would be more likely to occur via CPOE than conventional written orders (see our May 20, 2008 Patient Safety Tip of the Week CPOE Unintended Consequences: Are Wrong Patient Errors More Common?). We discussed the need to clearly identify patients on all order entry screens and identified 5 common scenarios that can lead to entering orders on the wrong patient via CPOE (see the May 20, 2008 Tip for details):
Now a new study (Adelman 2012) actually provides a quantitative estimate of how frequently wrong-patient CPOE may occur. Those authors developed a computer tool that identified instances where orders were entered on a patient, promptly retracted, and then entered on a different patient. Using this tool they estimated over 5000 orders were placed on wrong patients at four hospitals during one year. They then piloted two distinct interventions, an ID-verify alert and an ID-reentry function. The former reduced the odds of a retract-and-reorder event by 16% and the latter reduced the odds by an even greater magnitude (41%).
A prior study (Koppel 2008) had shown that discontinuation of medication orders within 2 hours of order input was a good predictor of prescribing errors. So Adelman et al. hypothesized that orders entered on a patient, promptly retracted, and then entered on a different patient would be a good indicator of wrong-patient errors. This combination would actually be identifying near-misses in most cases but the concept is important to provide an estimate of how often this happens. So the tool they developed identified instances where there were orders (for medications, bloodwork, imaging, or general care) that were retracted within 10 minutes and then reordered by the same provider on a different patient within 10 minutes. They also did phone interviews with the providers to confirm that these were wrong-patient occurrences and identify factors that facilitated such occurrences. The phone interviews confirmed that the vast majority of such occurrences were, indeed, wrong-patient errors (the positive predictive value of the tool was 76.2%). Using this they estimated that there were 14 wrong-patient CPOE errors daily at their facilities, that one in six providers had at least one wrong-patient error, and that one in 37 patients admitted to the hospital had an order intended for another patient for an overall estimated rate of 58 wrong-patient orders per 100,000 orders.
About 10% of the errors were juxtaposition errors where mis-clicking on the wrong patient name in a list led to the error (this is the cursor/stylus error in our prior columns). But over 80% of the errors were due to interruptions of various sorts.
The intervention tools they developed were simple yet elegant. The ID-verify alert was triggered by opening an order entry screen and prompted the physician with the patient name, gender and age and the physician was required to acknowledge that was the correct patient before being allowed to proceed with order entry. The ID-reentry function prevents the provider from accessing the order entry screen until he/she re-enters the patients initials, gender and age. These interventions were piloted in a randomized fashion. While the ID-verify alert reduced errors by 16%, the ID-reentry function reduced them by 41%.
They estimated that the ID-reentry function required an extra 6.6 seconds for every order session. Though that sounds like an insignificant extra time, the authors note that could result in a significant amount of time when accumulated over a long period. However, they note that the interventions were well accepted by the providers.
Though the Adelman study just looked at wrong-patient order entry, the same concepts apply to any input into electronic medical records. Both the Adelman study and the Hyman study quote a paper by Wilcox et al. (Wilcox 2011) that found 51 wrong notes written in the electronic chart per 100,000 notes. Wilcox et al. used an alert with patient name and medical record number which the provider had to click yes to verify patient ID and they were able to reduce wrong-patient notes by 40%.
Tools like these and the one described in our June 26, 2012 Patient Safety Tip of the Week Using Patient Photos to Reduce CPOE Errors developed by Childrens Hospital of Colorado (Hyman 2012) have great potential to reduce wrong-patient CPOE errors and EHR entry errors. The simple tool developed by Adelman et al. should be easily adaptable to most hospital CPOE systems and could at least provide you with good estimates of how often such wrong-patient events or near-misses are occurring.
See some of our other Patient Safety Tip of the Week columns dealing with unintended consequences of technology and other healthcare IT issues:
Hyman D, Laire M, Redmond D, Kaplan DW. The Use of Patient Pictures and Verification Screens to Reduce Computerized Provider Order Entry Errors. Pediatrics 2012; 130: 1-9 Published online June 4, 2012 (10.1542/peds.2011-2984)
Adelman JS, Kalkut GE, Schechter CB, et al. Understanding and preventing wrong-patient electronic orders: a randomized controlled trial. J Am Med Inform Assoc 2012; Published online 29 June 2012
Koppel R, Leonard CE, Localio AR, et al. Case Report: Identifying and Quantifying Medication Errors: Evaluation of Rapidly Discontinued Medication Orders Submitted to a Computerized Physician Order Entry System. J Am Med Inform Assoc 2008; 15: 461-465
Wilcox AB, Chen Y-H, Hripcsak G. Minimizing electronic health record patient-note mismatches. J Am Med Inform Assoc 2011;18:511-514 Published Online First: 12 April 2011
July 24, 2012
FDA and Extended-Release/Long-Acting Opioids
In our June 28, 2011 Patient Safety Tip of the Week Long-Acting and Extended-Release Opioid Dangers we discussed potential dangers of a number of long-acting or extended-release opioids, including fentanyl patches. Then in our September 13, 2011 Patient Safety Tip of the Week Do You Use Fentanyl Transdermal Patches Safely? we provided numerous recommendations to improve the safety of fentanyl patches. We stressed the importance of appropriate disposal of such patches because of potential dangers to children and pets.
Now, as one piece of a multi-pronged approach by the government to reduce misuse, abuse and addiction with opioids, the FDA has recently announced a new REMS (Risk Evaluation and Mitigation Strategy) program for extended-release and long-acting opioids (FDA 2012a). The FDA has mandated that the manufacturers of these agents fund educational programs for providers who prescribe these drugs. The educational programs, however, must be based on a blueprint established by the FDA. That blueprint also includes educational materials for patients, including not only safe and appropriate use of these agents but also proper disposal techniques (see our May 2012 Whats New in the Patient Safety World columnAnother Fentanyl Patch Warning from FDA).
The materials in the FDA blueprint are actually very good. They educate providers and prescribers on abuse potential, tools for screening for addiction, understanding the difference between opioid-nave and opioid-tolerant patients, acute vs. chronic pain, titration strategies, potency differences between various products, establishing goals and monitoring effects, and how to counsel patients on use and disposal of opioid products. The document is over 40 pages long but reading it is well worth your while.
These drugs are intended for use in management of chronic pain and in patients who are opioid-tolerant. Yet more and more we are seeing them being used (inappropriately) in patients with acute pain and those who are opioid-nave. We also see them being prescribed in patients at high risk for respiratory depression, such as those with COPD or sleep apnea. The advice here is important not just to those providers who prescribe these agents but is relevant for anyone who works in an emergency department or hospital or other healthcare facility. Weve seen cases where application of a new transdermal patch without removal of the old one leads to unintentional overdoses and cases where patients intentionally overdosed on long-acting preparations and did not develop respiratory depression until almost 24 hours later. So a thorough understanding of multiple aspects of these agents and preparations is critical.
The FDA blueprint does a good job of discussing abuse/addiction potential and provides tables for each drug preparation that give dosing information, equipotency information relative to morphine, specific instructions and special warnings specific to each drug. It discusses nuances such as which drugs are metabolized via the various cytochrome systems that may lead to drug-drug interactions and which may predispose to the long-QT interval syndrome (torsades de pointes) and which may predispose to the serotonin syndrome or other relatively rare conditions.
The blueprint also stresses the importance of educating not only patients who will be using these agents but also their caregivers and families. It is extremely important that the latter understand safe and secure storage and disposal of such agents to reduce the risk that children or pets may inadvertently be exposed to these dangerous agents.
The FDA also just announced it will be forcing companies to remove unapproved oxycodone products from the market (FDA 2012b). Many of these products came onto the market prior to certain FDA regulatory requirements. Currently, the law requires that new drugs be shown to be safe, effective, adequately labeled, and of appropriate manufacturing quality prior to being approved by FDA for marketing in the United States. In an attempt to address this issue, the FDAs Unapproved Drugs Initiative, which began in 2006, has been systematically targeting marketed unapproved drugs and removing them from the market.
There are FDA-approved versions of these drug products on the market that contain the same active ingredient, strength(s), and dosage forms as the unapproved products. All of the manufacturers of the approved versions of these products have given FDA assurances that they can adequately supply the market.
And talk about good timing! There was just a great article in the New England Journal of Medicine (Boyer 2012) on management of opioid analgesic overdoses. It highlights the pathophysiology, clinical manifestations, management, and special considerations. It points out that tolerance to the respiratory depression from opioids develops more slowly than tolerance to the analgesic effects. This narrows the therapeutic window and, paradoxically, patients with long-standing opioid therapy may be at greater risk for respiratory depression. It highlights, as we have in several columns, that the effect of the reversal agent naloxone may wear off long before the effect of the opioid wears off, raising the danger of recurrence of respiratory depression. Other clinical pearls are the necessity to totally unclothe the patient so a thorough search for fentanyl patches can be done and to always consider the possibility of coexisting acetaminophen overdose since so many opioid preparations are mixtures of acetaminophen plus the opioid. Good article, great timing!
And we think youll learn a lot from our prior articles pertaining to long-acting and/or extended release preparations of opioids:
June 28, 2011 Long-Acting and Extended-Release Opioid Dangers
September 13, 2011 Do You Use Fentanyl Transdermal Patches Safely?
FDA. Extended-Release (ER) And Long-Acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS). July 9, 2012
FDA. FDA prompts companies to remove certain unapproved oxycodone products from market. July 5, 2012
Boyer E. Management of Opioid Analgesic Overdose. N Engl J Med 2012; 367: 146-155
July 31, 2012
Surgical Case Duration and Miscommunications
Surgical case duration is one of the few modifiable risk factors for surgical infections. A number of studies in the past have demonstrated an association between perioperative infection and the duration of the surgical procedure. In our January 2010 Whats New in the Patient Safety World column Operative Duration and Infection we noted a study (Proctor et al 2010) which looked at a large database of general surgical procedures and demonstrated a linear relationship between duration of surgery and infectious complications. The infectious complication rate increased by 2.5% per half hour and hospital length of stay (LOS) also increased geometrically by 6% per half hour.
But prolonged surgeries also increase risks other than that of infection. Our March 10, 2009 Patient Safety Tip of the Week Prolonged Surgical Duration and Time Awareness discussed time unawareness during many surgeries. In addition to the potential impact on infectious complications, we noted that there are other potential patient safety issues related to prolonged surgical duration such as DVT, decubiti, hypothermia, fluid/electrolyte shifts, nerve compression, compartment syndromes, and rhabdomyolysis. Long-duration cases also increase the likelihood of personnel changes that increase the chance of retained foreign objects. And the fatigue factor comes into play with longer cases, increasing the likelihood of a variety of other errors.
There are many factors that may lead to increased surgical durations, including case type and complexity, emergency vs. elective nature, and proficiency of the surgeon, lack of team familiarity, presence of trainees and poor communication.
A recent article (Gillespie 2012) looked at various factors involved in prolonging surgery. They looked at the above factors plus intraoperative interruptions and whether or not pre-op huddles/briefings were done. The mean duration of surgery for all cases was 85 minutes, compared to an expected mean duration of 60 minutes. They noted that preoperative briefings occurred in only 12.5% of cases, despite that practice having been mandated at the study hospital. Some of their teams were set teams that had worked together for many years. Others were teams that came together on a more ad hoc basis. Communication failures occurred in 57% of the cases, an average of 1.9 per case. Interruptions occurred in 66.9% of cases (mean number of interruptons per case = 2.3). But when they did regression analyses the only factor that independently predicted deviation from expected duration of surgery was the number of miscommunications. Such miscommunications were more frequent when some members of the OR team had less experience. They also had examples where insufficient or inaccurate information was conveyed but the recipient did not seek clarification. Interestingly, interruptions did not appear to predict prolonged surgery. And there did not appear to be a correlation with lack of team familiarity nor with out of hours surgery.
There is not enough we can say about the value of team training programs like TeamSTEPPS or any of a number of crew resource management programs that focus on ways to improve communication among team members. Assuring that standard nomenclature is used and that hearback is routinely used are fundamental to good team communication. Bucking the hierarchical structure of the OR is also crucial.
Gillespie et al. spend a good deal of time discussing the value of preop briefings. We, of course, are big fans of the preop huddle. See our prior columns:
During a preop huddle the team will often recognize that a piece of important equipment is missing, avoiding the considerable delay that might have occurred if that had been discovered well into the case. Checklists have been utilized more often for the preoperative briefings or huddles. We previously noted a study by Lingard et al (Lingard 2008) that used a checklist to structure short team briefings and documented reduction in the number of communication failures. Our December 9, 2008 Patient Safety Tip of the Week Huddles in Healthcare discussed an article by Nundy and colleagues at Johns Hopkins (Nundy 2008). They used a very simple format for pre-operative briefings that led to a 31% reduction in unexpected delays in the OR and a 19% reduction in communication breakdowns that lead to delays.
We recommend that the OR team, during the presurgical huddle, should discuss issues related to prolonged cases. For example, they should discuss whether intraoperative DVT prophylaxis should begin if the procedure lasts beyond a certain duration. Or discuss at what duration a repositioning of the patient (to avoid nerve compression, compartment syndrome, or rhabdomyolysis) might be wise. And it would be very useful to have an estimate of time remaining to again trigger some discussion on the above issues. In addition to the DVT prophylaxis and repositioning issues, it might raise questions about the need to temporarily ease up on traction. It might direct attention to maintenance of the patients body temperature. In a very prolonged case it might raise questions about the need for further doses of prophylactic antibiotics.
So good communication begins before the patient has actually entered the OR and is necessary throughout the case to ensure more efficient and safe performance of surgery. And dont forget that the postop debriefing may help you save time during your next case as well!
No one is happy with surgical cases that take too long. And, by the way, ask your CFO what that extra 20 minutes per case translates to in financial terms over the course of a year!
And while the Gillespie study did not find interruptions as an independent predictor of surgical case duration, the impact of distractions and interruptions on surgical errors is significant. A new study (Feuerbacher 2012) of surgical residents in an OR simulator environment clearly demonstrates the impact of OR distractions and interruptions (ORDIs) in producing surgical errors. Because most prior research on ORDIs had used somewhat artificial distractions and interruptions (such as mental arithmetic) the authors sought to use realistic ORDIs that they had previously observed in real ORs. The ORDIs included an unexpected reaching movement by an observer, a ringing cell phone answered by an observer, an unrelated side conversation, a noise from a dropped metal tray, a question about management of a previous surgical patient in the recovery room, and a question about why the resident chose that profession. Eight of eighteen participants committed significant surgical errors during simulated laparoscopic cholecystectomy when distracted or interrupted, compared to only one of eighteen who were not interrupted or distracted. Moreover, 56% forgot to make a scheduled announcement when distracted or interrupted vs. 22% in the uninterrupted group. Interestingly, time of day was important. Virtually all the errors occurred after 1 PM. And the latter could not be explained by fatigue factors or time of duty (these were measured separately).
The time of day phenomenon is also interesting. Recall that the polyp detection rate in colonoscopies also shows a pattern in which fewer polyps are detected later in the day (see our May 3, 2011 Patient Safety Tip of the Week Its All in the Timing). Since the data collected in the Feuerbacher study seems to exclude fatigue as the key factor, there may well be other important factors that have yet to be delineated in this observational phenomenon of more errors later in the day.
Weve done a number of columns on the deleterious effects of interruptions and distractions for physicians, nurses, pharmacists and others:
Procter LD, Davenport DL, Bernard AC, Zwischenberger JB. General Surgical Operative Duration Is Associated with Increased Risk-Adjusted Infectious Complication Rates and Length of Hospital Stay, Journal of the Amercican College of Surgeons 2010; 210: 60-65
Gillespie BM, Chaboyer W, Fairweather N. Factors that influence the expected length of operation: results of a prospective study. BMJ Qual Saf 2012; 21(1): 3-12 Published Online First: 14 October 2011 doi:10.1136/bmjqs-2011-000169
Lingard L, Regehr G, Orser B, et al. Evaluation of a Preoperative Checklist and Team Briefing Among Surgeons, Nurses, and Anesthesiologists to Reduce Failures in Communication. Arch Surg, Jan 2008; 143: 12-17
Nundy S, Mukherjee A, Sexton JB, et al. Impact of Preoperative Briefings on Operating Room Delays: A Preliminary Report. Arch Surg 2008; 143(11): 1068-1072
Feuerbacher RL, Funk KH, Spight DH, et al. Realistic Distractions and Interruptions That Impair Simulated Surgical Performance by Novice Surgeons. Arch Surg 2012; (): 1-5 published online first July 2012
August 7, 2012 Cognition, Post-Op Delirium, and Post-Op Outcomes
Youve heard us harp on this topic before (see our August 17, 2010 Patient Safety Tip of the Week Preoperative Consultation Time to Change) rather than wasting a lot of time and money doing extensive preoperative cardiac evaluations for non-cardiac surgery we get a lot more bang for the buck doing simple screening for three risks: obstructive sleep apnea (OSA), frailty, and cognition/delirium. An otherwise excellent recent review on the preoperative medical consultation (Rivera 2012) briefly discusses OSA but does not even mention screening for frailty or cognitive dysfunction at all.
Yet identification of each of these three risk factors increases the likelihood that the patient will have postoperative complications and poor outcomes. More importantly identification of these risks should lead to interventions designed to reduce the chances of those adverse postoperative outcomes. Screening tools for each are simple and inexpensive. For OSA the STOP-Bang questionnaire is very good at identifying patients likely to have OSA. For frailty there are several frailty indices or tools available but the timed up-and-go test is easy to do and reliable. And there are simple tools described below (such as the mini-Cog test) that can be done quickly in the office that help predict post-op delirium and post-op decline in cognitive function.
We had previously cited the work of Robinson and colleagues (see our November 2011 Whats New in the Patient Safety World column Timed Up-and-Go Test and Surgical Outcomes and our August 9, 2011 Patient Safety Tip of the Week Frailty and the Surgical Patient) in predicting postoperative complications based on frailty measures (Robinson 2009, Robinson 2011).
A new study by that group (Robinson 2012) of elderly patients scheduled to undergo elective surgery with expected post-op ICU stays (mostly males in the VA system) used the Mini-Cog score to assess cognitive function preoperatively and demonstrated that patients scoring 3 or less were more likely to have post-op delirium, longer hospital stays, increased likelihood of discharge to institutional care, and higher 6-month mortality. The risk of delirium was doubled (78% vs. 37%) and delirium lasted longer in those patients scoring 3 or below on the Mini-Cog. Average LOS was 15 days in those with low Mini-Cog scores compared to 9 days in those with higher scores. Six-month mortality rates were 13% vs. 5% and discharge institutionalization rates were 42% vs. 18% respectively for those scoring 3 or below vs. those above 3 on the Mini-Cog.
The Mini-Cog (Borson 2000) consists of giving the patient 3 unrelated words to recall, then having them draw a clock with hands at a specified time (the patient is asked what the 3 words are after they have finished drawing the clock). Scoring (SHM 2004) is 0 to 5 (1 poiint for each word recalled and 2 points for drawing a normal clock). The whole test usually only takes about 2-3 minutes. It is well validated in multiple populations.
The relationship of delirium to mortality is well known and the Robinson study suggests that delirium was an effect modifier rather than a confounder in the relationship of cognitive impairment with mortality.
Two very instructive articles on cognition and delirium in surgical patients were just published. Marcantonio (Marcantonio 2012) uses a clinical case to discuss multiple aspects of delirium, including pathophysiology, risk factors, precipitating factors, management, and preventive interventions. It is an interesting case where a patient developed a slightly delayed delirium (that coincided with onset of another post-op complication), then had a recurrence of delirium after a second surgery, yet underwent a third surgery without developing delirium. A highlighted point was that the patient had not yet fully recovered from the first delirium episode when the second surgery was needed but had fully returned to baseline before the third surgery. The article has a nice table showing the additive effects of predisposing factors (eg. advanced age, preexisting dementia, depression, functional disability) and precipitating factors (eg. surgery, anesthesia, sedative drugs, benzodiazepines, poorly controlled pain, prolonged ICU stays, other postop complications, etc.). He makes a good point that a patient with few predisposing factors needs more precipitating factors in order for delirium to develop, whereas a patient with several predisposing factors may only need a few precipitating factors. The article also provides a good discussion of the evidence base for treating or preventing delirium (including both what works and what does not work). Excellent article.
Mercantonio was also a coauthor of the second article (Saczynski 2012) that deals with the trajectories of cognitive dysfunction seen after postoperative delirium. In this study they followed 225 patients aged 60 or older who underwent CABG or heart valve surgery. 46% of the patients developed delirium. Those that did develop delirium had lower pre-op MMSE (mini-mental state exam) scores, had bigger drops in MMSE scores shortly after surgery, and had lower cognitive function at one year after surgery. A higher percentage of those with delirium had not returned to their pre-op cognitive level by 6 months but the difference was no longer significant at 12 months. Thus, the typical trajectory for those who develop postop delirium is an initial rapid decline in cognitive function followed by a prolonged period of impairment.
These articles stress the value of assessment of the patients cognitive status by simple means before the patient undergoes surgery. Knowledge of that status may help avoid the occurrence of post-op delirium and other complications and also help in planning the patients immediate and prolonged postoperative course and management. A few minutes up front can save a lot of time down the line!
Some of our prior columns on delirium assessment and management:
Rivera RA, Nguyen MT, Martinez-Osorio JI, et al. Preoperative medical consultation: maximizing its benefits. Am J Surg 2012; ahead of print July 9, 2012
Robinson TN, Eiseman B, Wallace JI, et al. Redefining Geriatric Preoperative Assessment Using Frailty, Disability and Co-Morbidity. Annals of Surgery 2009; 250(3): 449-455, September 2009
Robinson TN, Wallace JI, Wu DS, et al. Accumulated Frailty Characteristics Predict Postoperative Discharge Institutionalization in the Geriatric Patient. J Am Coll Surg 2011; 213(1): 37-42, July 2011
Robinson TN, Wu DS, Pointer LF, et al. Preoperative Cognitive Dysfunction Is Related to Adverse Postoperative Outcomes in the Elderly. J Am Coll Surg 2012; 215(1): 12-18
Marcantonio ER. Clinician's Corner. Postoperative DeliriumA 76-Year-Old Woman With Delirium Following Surgery. JAMA. 2012; 308(1): 73-81
Saczynski JS, Marcantonio ER, Quach L, et al. Cognitive Trajectories after Postoperative Delirium. N Engl J Med 2012; 367: 30-39
Borson S, Scanlan J, Brush M, Vitaliano P, Dokmak A. The mini-cog: a cognitive vital signs measure for dementia screening in multi-lingual elderly. Int J Geriatr Psychiatry 2000; 15(11): 10211027
SHM (Society for Hospital Medicine). The Mini-Cog Assessment Instrument for Dementia. 2004
August 14, 2012
Gait Speed: A New Vital Sign?
Last week (see our August 7, 2012 Patient Safety Tip of the Week Cognition, Post-Op Delirium, and Post-Op Outcomes) we noted that in the pre-op evaluation we get a lot more bang for the buck doing simple screening for three risks: obstructive sleep apnea (OSA), frailty, and cognition/delirium. An otherwise excellent recent review on the preoperative medical consultation (Rivera 2012) briefly discusses OSA but does not even mention screening for frailty or cognitive dysfunction at all. We had previously cited the work of Robinson and colleagues (see our November 2011 Whats New in the Patient Safety World column Timed Up-and-Go Test and Surgical Outcomes and our August 9, 2011 Patient Safety Tip of the Week Frailty and the Surgical Patient) in predicting postoperative complications based on frailty measures (Robinson 2009, Robinson 2011).
Several more recent papers in the surgical literature have demonstrated that measures of frailty reliably predict post-operative morbidity and mortality. One study (Tan 2012) found that the Fried index (see below) predicted morbidity in elderly patients undergoing colorectal cancer resection even in patients whose comorbidities were already optimized. Another (Farhat 2012), using a modification of the Canadian Study of Health and Aging Frailty index, showed that as the modified frailty index increased there were associated increases in wound infections, various other adverse outcomes, and mortality. A third study (Nutt 2012) showed that a simple shuttle walk test performed pre-operatively predicted morbidity and mortality after elective major colorectal surgery.
Gait speed has been an integral part of frailty assessments since Fried et al developed their well-known Frailty Index (Fried 2001). About a year ago a study (Studenski 2011) correlated gait speed with survival in older adults, demonstrating that survival predicted by age, sex and gait speed was at least as good as survival predicted by age, sex, chronic conditions, smoking history, blood pressure, BMI and hospitalization.
While gait speed is obviously impacted by orthopedic, rheumatological and neurological conditions affecting the lower extremities, it is impacted much more globally by multiple organ systems (cardiac, respiratory, CNS, etc.) and therefore is a good measure of overall functional status and/or physiological reserve.
This year there has been a renewed interest in research on gait speed and a variety of outcomes. And researchers have begun to look at not just a single measurement of gait speed but also at changes in gait speed over time and variability of gait speed. A recent study (Dodge 2012) demonstrated that both gait speed and the trajectory of variability in gait speed may predict mild cognitive impairment. They studied independently living patients aged 70 and older and looked at measures of cognitive function and gait speed over time. They separated patients into fast, moderate and slow groups based on measurements of gait speed taken unobtrusively in patients in their homes. Those in the fast and moderate groups had a slight decline in gait speed over time whereas those in the slow group had a more rapid decline in speed. Patients with mild cognitive impairment were 9 times more likely to be in the slow category and 5 times more likely to be in the moderate group. Moreover, they found significant day-to-day fluctuations in gait speed and suggest that monitoring gait speed variation over time may be much more valuable than a typical one-time assessment on an office visit. Indeed, several more studies presented at the 2012 Alzhiemers Association International Conference (Cassels 2012) have expanded on this work. One study from Switzerland showed that cognitive function declined as gait speed or its variability declined over time. Another looked at the impact of dual tasks on gait speed. Those with cognitive impairment had slower gaits during dual tasks (such as counting backwards or naming animals) than they did when walking normally. (We pride ourselves at being able to pick out those drivers on the highway who are talking on cell phones. They are the ones who drive fast, then slow, the fast again. Variability in speed is their hallmark. Try it sometime. Wonder if they have cognitive dysfunction, too!).
And there may be more importance in identifying slow gait speed in the elderly. A new study (Odden 2012), using data from NHANES surveys, looked at correlation between blood pressure and gait speed and survival. They found that among fast walkers high blood pressure was associated with higher mortality. For slower walkers there was no association between blood pressure and mortality. But for those who could not complete the walking test, there was an inverse relationship between blood pressure and mortality, i.e. those with higher BP lived longer. Though they speculate on the mechanisms, they note that identification of frailty through gait speed perhaps should lead to less aggressive management of blood pressure. Further research in needed in this area but the findings are nevertheless very interesting.
Gait speed is easy to measure, inexpensive, and not time-consuming. An incredible amount of predictive information can come from such assessment.
Robinson TN, Eiseman B, Wallace JI, et al. Redefining Geriatric Preoperative Assessment Using Frailty, Disability and Co-Morbidity. Annals of Surgery 2009; 250(3): 449-455, September 2009
Robinson TN, Wallace JI, Wu DS, et al. Accumulated Frailty Characteristics Predict Postoperative Discharge Institutionalization in the Geriatric Patient. J Am Coll Surg 2011; 213(1): 37-42, July 2011
Studenski S, Perera S, Patel K, et al. Gait Speed and Survival in Older Adults. JAMA 2011; 305(1): 50-58.
Fried LP, Tangen CM, Walston J; et al. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001; 56(3): M146-M156
Odden MC, Peralta CA, Haan MN, Covinsky KE. Rethinking the Association of High Blood Pressure With Mortality in Elderly Adults. The Impact of Frailty. Arch Intern Med. 2012; (): 1-7 published online July 2012
Dodge HH, Mattek NC, Austin D, et al. In-home walking speeds and variability trajectories associated with mild cognitive impairment. Neurology 2012; 78: 1946-1952
Cassels C. Walking Irregularities a Harbinger of Cognitive Decline? Medscape Medical News July 15, 2012
Nutt CL, Russell JC. Use of the pre-operative shuttle walk test to predict morbidity and mortality after elective major colorectal surgery. Anaesthesia 2012; 67: 839849
Tan K-Y, Kawamura YJ, Tokomitsu A, Tang T. Assessment for frailty is useful for predicting morbidity in elderly patients undergoing colorectal cancer resection whose comorbidities are already optimized. Amer J Surg 2012; 204(2) 139-143
Farhat JS, Velanovic V, Falvo AJ, et al. Are the frail destined to fail? Frailty index as predictor of surgical morbidity and mortality in the elderly. Journal of Trauma and Acute Care Surgery 2012; 72(6): 1526-1531
August 21, 2012
More on Missed Followup of Tests in Hospital
The problem of significant abnormal test results “slipping through the cracks” is a serious cause for preventable adverse patient outcomes and a leading cause of malpractice settlements. For many years we have stressed the importance of including “test results pending” in discharge summaries and in verbal handoffs as well (see our March 1, 2011 Patient Safety Tip of the Week “Tests Pending at Discharge” and the list of other columns below).
In our March 9, 2010 Patient Safety Tip of the Week “Communication of Urgent or Unexpected Radiology Findings” we noted a study (Were et al 2009) which showed that only 16% of tests with results pending actually are documented in discharge summaries.
A new study (Ong 2012) further quantifies some of the risks of tests ordered late in the course of a hospitalization. They reviewed clinical pathology tests ordered on inpatients at a large teaching hospital in Australia. Overall 37% of patients had at least one test whose results were not reviewed at discharge. The percent of tests not reviewed varied dramatically by when they were ordered. While the overall rate of test results not reviewed was 3% at discharge and 1.5% two months after discharge, 47% of all missed test results occurred with tests ordered on the day of discharge. 21% of tests ordered on the day of discharge were not followed up, compared to only 1.8% ordered on other days. Moreover, 14.7% of unreviewed tests at discharge were abnormal. Of those still not reviewed by 2 months after discharge 10.8% had abnormal results.
Our March 1, 2011 Patient Safety Tip of the Week “Tests Pending at Discharge” noted a study (Callen 2011) that found lack of followup on test results ranged from 20-60% for inpatients and 1-75% for emergency room patients. And the lack of followup had clinical implications since some of the results were considered critical or urgent or otherwise actionable.
So there is little doubt that failure to follow up on test results during such transitions of care is both common and potentially dangerous.
So what are the solutions? When we actually sat down to dictate discharge summaries and tried to identify these tests that had been done but not yet resulted we were astonished at how difficult it was to identify those tests! Even as lengths of stay plummet it is almost impossible to wade through either a paper chart or an electronic medical record and easily identify what tests were ordered, then look up the results and identify those lacking results. However, you can write computer scripts in the electronic medical record that will do that for you. So at one hospital we work with the IT staff developed 2 solutions: (1) a screen that shows “tests done but not yet resulted” and (2) a screen that shows physicians “test results coming in after discharge” for recently discharged patients. Hospitalists or any physicians managing inpatients typically go to the first screen when doing a discharge summary and can then include those tests in the discharge summary to alert the person providing the next level of care to check those results. That screen is patient-specific. The other screen is available any time the physician logs on and lists all that physician’s recently discharged patients so the physician can click on a patient name and see results that have come in after discharge. Then (hopefully) they convey those results to the next caregiver in the continuum who needs those results to manage the patient on an ongoing basis.
One of the things we found after implementation was that physicians were often deluged with long lists of results, many of which were not considered particularly important. So the risk of “alert fatigue” reared its ugly head. We had to pare back the lists and prioritize the tests listed to include the more important ones. (Anecdotally, seeing the longer lists initially probably did help physicians recognize that many of the tests they ordered during a hospital stay probably were of little value and we did see a slight decline in inpatient lab tests.) Note also we had to do the same paring and prioritizing when we began tracking test results for patients seen in the ambulatory clinics.
Our system required the physician to log onto the computer system to see the “test results coming in after discharge” list. Another group (Dalal 2012) designed and implemented an automated system that notified attending physicians by email when those test results came in. They also sent a carbon copy to the primary care physicians. They, too, found they had to suppress selected tests to avoid too many email notifications. Ultimately they delivered an average of 1.6 email notifications per discharged patient. An overwhelming majority (84%) of inpatient attending physicians in that study were satisfied with the system. Note that this stands in sharp contrast to their first attempt at a computer solution (Dalal 2011) that identified numerous workflow issues and other barriers to adoption.
So we know that IT solutions can be helpful. But there remain some concerns. One concern we always have is related to the transfer of responsibility for care of the patients. We’ve noted on numerous occasions the study (Singh 2009) that demonstrated notification of more than one provider actually doubled the likelihood of no one responding. It needs to be made clear who will be responsible for following up on those pending test results. We always recommend that be discussed in a phone call at the transition of care but that is not always possible.
Secondly, the issue of attribution of a patient to a physician is harder than it sounds. Tests may originally be ordered in the ER prior to the decision to admit. In such cases the ER physician’s name may be attached to such tests. The patient then gets admitted under one attending or hospitalist but those physicians may also change during the course of a hospitalization. Yet tests they ordered may be attributed to them. The situation gets even more complicated in academic medical centers where multiple housestaff are involved in care. Ultimately you want all test results to come back to the attending of record at the time of discharge so that he/she can identify pending tests results and note them in the discharge summary. The previously noted study by Were et al. (Were et al 2009) also identified multiple changes in attendings as an issue and difficulty identifying the physician who will ultimately follow the patient after discharge.
While technological solutions are likely to be of benefit, to date there remains scant evidence that they have had a significant impact on resolution of this problem. The Callen paper notes that having an online endorsement or acknowledgement feature would at least help organizations better track how important test results are being communicated.
Suffice it to say that the ideal system for ensuring followup of all test results remains elusive.
See also our other columns on communicating significant results:
Were MC, Li X, Kesterson J, et al. Adequacy of Hospital Discharge Summaries in Documenting Tests with Pending Results and Outpatient Follow-up Providers. Journal of General Internal Medicine 2009; 24(9): 1002-1006
Ong M-S, Magrabi F, Jones G, Coiera E. Last Orders: Follow-up of Tests Ordered on the Day of Hospital Discharge (Research Letter). Arch Intern Med 2012; published online first August 13, 2012
Callen J, Georgiou A, Li J, Westbrook JI. The safety implications of missed test results for hospitalised patients: a systematic review. BMJ Qual Saf 2011; 20: 194-199 Published Online First: 7 February 2011
Dalal AK, Schnipper JL, Poon EG, et al. Design and implementation of an automated email notification system for results of tests pending at discharge. J Am Med Inform Assoc 2012; 19(4): 523-528
Dalal AK, Poon EG, Karson AS, et al. Lessons learned from implementation of a computerized application for pending tests at hospital discharge. Journal of Hospital Medicine 2011; 6(1): 16-21 (first published online November 15, 2011)
Singh H, Thomas EJ, Mani S, et al. Timely Follow-up of Abnormal Diagnostic Imaging Test Results in an Outpatient Setting. Arch Intern Med. 2009; 169(17): 1578-1586.
August 28, 2012
New Care Model Copes with Interruptions Better
A lot can be learned by simply taking time to observe workflows in a healthcare setting. Some time just go to a patient care unit and watch a nurse as he/she tries to carry out typical daily tasks. You, of course, see interruptions for answering call bells. And on the way back from that patient room you see a visiting family asking the nurse for directions to the cafeteria. Then Radiology calls the nurse to note that the physician did not correctly fill out the CT scan requisition so the nurse now has to track down the physician. A physician then interrupts the nurse to ask where patient X has gone. Another physician calls the floor to give a verbal order so the nurse has to take that order and enter it into the computer. Yet another physician calls to ask the nurse to look up the result of today’s INR so the warfarin order can be given. And the nurse has to walk to the other end of the unit to get some supplies to carry out a patient task. And the problem is even worse on weekends. Our December 15, 2009 Patient Safety Tip of the Week “The Weekend Effect” noted how the lack of non-nursing staff on weekends actually adds both considerable workload and interruptions to nursing staff. We have also seen that clerical staff have often been reduced or eliminated in the recent economic downturn, further accentuating the problem of interruptions for nursing staff. The nurse now ends up doing not only nursing jobs but clerical tasks as well. Even housekeeping tasks. It’s a wonder nurses can get any patient care activities done!
Several of our prior Patient Safety Tips of the Week have dealt with distractions and interruptions and their impact on patient safety and patient care (see list at end of today’s column). Interruptions and distractions affect nurses, physicians, pharmacists and not just “clinical” staff but really all healthcare workers. Our August 25, 2009 Patient Safety Tip of the Week “Interruptions, Distractions, Inattention…Oops!” highlighted some excellent studies on interruptions and distractions in healthcare. In that we provided references to some good statistics about the frequency and nature of interruptions and distractions and listed some recommendations about how to avoid them. Our May 4, 2010 Patient Safety Tip of the Week “More on the Impact of Interruptions” cited an excellent article on the impact of interruptions on medication administration errors (Westbrook 2010). That article also had a good discussion of strategies to minimize interruptions and future directions for research on reducing the occurrence of interruptions.
But despite a good literature on causes and contributing factors, it’s very difficult to find good studies showing interventions that successfully reduce interruptions and improve patient care. Interventions such as hourly rounding (see our July 26, 2011 Patient Safety Tip of the Week “Hourly Rounding”) which, when done well, not only improves patient satisfaction but also reduces nurse interruptions and may improve patient safety outcomes.
An innovative program at University of Pittsburgh Medical Center (UPMC) appears to have been successful in improving care while handling interruptions (Kowinsky 2012). As part of a quality improvement initiative they brainstormed and identified factors contributing to inefficient workflow, identified potential ways to address these, simulated a potential solution and then piloted the solution on one unit.
Their analysis basically categorized two types of work: “predictable” and “unpredictable”. The predictable work occurs repetitively and reliably and can be scheduled. This includes things like rounding, feeding, repositioning, vital signs, etc. The unpredictable work consists of tasks that tend to occur randomly over the course of the day and includes things like answering call bells, blood draws, transporting patients, handling admissions and discharges, etc. Because of the two types of work they created two types of roles to deal with them. The “reliable rounder” addressed the predictable work and the “variable rounder” addressed the unpredictable work. During the simulation exercise carried out on an unoccupied available nursing unit, they developed scenarios and scripts and had observers watch and critique those doing role-playing. Frontline nurses participated with leaders and quality improvement staff and provided feedback to improve the model. They then piloted the new model on a telemetry unit. It was budget neutral since the same number of personnel was required as in the old model. The model was well received by hospital staff and at both 90 days and one year there were significant improvements in call bell response times, blood collection times, and other quality/service metrics.
This is a very interesting concept and the work is an example of a very well done quality improvement project. We encourage you to read the full article about the project.
It is interesting that this solution involved splitting up tasks. Another recent study (Tremblay 2012) suggests that in complex dynamic situations working in small teams confers more resistance to task interruptions. The biggest problems with interruptions, of course, are that we often skip steps when we resume the task and the task may take longer. These researchers found, in a firefighting simulation, that teaming up resulted in faster resumption times but only if both team members were interrupted at the same time. It would be of interest to evaluate this in healthcare settings or at least simulations.
Another recent paper (Colligan 2012) applies a human factors approach to decreasing interruptions at a centralized medication station. This article describes some inexpensive barriers used to protect tasks that are vulnerable to interruption while preserving sight lines, staff situational awareness, and staff and patient/family collegiality.
Other interventions might include cordoning off an area and make it a “no-interruptions zone” when a nurse is preparing, dispensing, administering, or otherwise handling medications. Well-placed signage or good hospital services brochures may help minimize interruptions for giving directions. A whiteboard showing where patients have gone may reduce some of the physician interruptions. And making sure physicians have remote access to the patient record can minimize those calls where the nurse has to do the searching. And making sure that your system allows the Lab or Radiology to directly contact physicians for clarifications or reporting urgent results can avoid the unnecessary “intermediary” role of the nurse.
In many cases physicians are the source of the interruptions. In fact, when a “Do Not Disturb” sign was piloted to assist medication administration by nurses (Pape 2005), all sorts of interruptions decreased with one exception: interruptions by physicians! Another study (Tomietto 2012) showed a multi-intervention program to reduce interruptions (that included wearing the red tabard during medication administration rounds) paradoxically reduced interruptions by patients but staff member interruptions increased! Interestingly, these are examples of some of the more subtle behaviors Lucian Leape refers to in his recent theme on our culture of disrespect (see our July 2012 What’s New in the Patient Safety World column “A Culture of Disrespect”).
And as we design interventions to reduce interruptions and their impact, we must balance these against any negative impact they might have on patient satisfaction. In the UK there was some pushback from patient advocacy groups when nurses began wearing the red “Do Not Interrupt” tabards during medication administration.
Sometimes simply taking the time to stand back and examine your workflows is a great patient safety exercise. If you work on reducing interruptions and distractions in your environment, we guarantee you will see not only gains in productivity and both patient and staff satisfaction but you will also see error rates decline and patient outcomes improve. Creative solutions, such as the one implemented in the Kowinsky paper, are best developed by those directly impacted by interruptions and distractions. Having your frontline staff involved in identifying the root causes of those interruptions can lead to creative solutions.
Prior Patient Safety Tips of the Week dealing with interruptions:
Westbrook JI., Woods A, Rob MI., Dunsmuir WTM, Day RO. Association of interruptions with an increased risk and severity of medication administration errors. Archives of Internal Medicine. 2010, 170(8): 683-690.
Kowinsky AM, Shovel J, McLaughlin M, et al. Separating Predictable and Unpredictable Work to Manage Interruptions and Promote Safe and Effective Work Flow. Journal of Nursing Care Quality 2012. 27(2): 109-115, April/June 2012
Tremblay S, Vachon F, Lafond D, Kramer C. Dealing With Task Interruptions in Complex Dynamic Environments: Are Two Heads Better Than One? Human Factors 2012; 54: 70-83
Colligan L, Guerlain S, Steck SE, Hoke TR. Designing for distractions: a human factors approach to decreasing interruptions at a centralised medication station. BMJ Qual Saf 2012; Published Online First 14 August 2012
Pape TM, Guerra DM, Muzquiz M, et al. Innovative Approaches to Reducing Nurses’ Distractions During Medication Administration. Journal of Continuing Education in Nursing 2005; 36(3): 108-116 May/June 2005
Tomietto M, Sartor A, Mazzocoli E, Palese A. Paradoxical effects of a hospital-based, multi-intervention programme aimed at reducing medication round interruptions. J Nursing Management 2012; 20(3): 335-343
September 4, 2012
More Infant Abductions
It’s not even been a year since we did a column on infant abduction (see our December 20, 2011 Patient Safety Tip of the Week “Infant Abduction”). Last month we saw 2 more infant abductions, one successful and one thwarted. Both the recent cases were eerily similar to the one we described last year.
In the Pittsburgh case (Mandak 2012) a young woman entered the hospital wearing hospital scrubs. She apparently told one employee she worked there and was just coming off duty and told another she was the sister of a mother being discharged and was there to drive her home. She then followed a discharge nurse into the room of the mother/newborn and family thought she was a nurse’s aide. The real nurse removed the security bands and left. The abductor then told the mother there was one more test that needed to be done and she would bring the infant right back. She then placed the infant in a zippered handbag in a secluded area and left the hospital with the infant. She had apparently told family she was pregnant but they were suspicious and when they heard about the abduction in the news they contacted local authorities who found the abductor and the infant unharmed.
In the California case (Mohajer 2012) a 48-y.o. woman entered a hospital stating she was there to visit a patient, then apparently posed as a nurse, entered the room of the mother/infant and told the mother to shower before the doctor came to examine her. Once the mother was out of sight she put the infant into a tote bag and attempted to carry the infant out of the hospital. The infant’s security bracelet set off hospital alarms and the hospital’s security/code response was able to find both the unharmed infant and the suspected abductor. In this case the abductor had also apparently told family/friends that she was pregnant.
The latter case illustrates how security systems and well-practiced “Code Pink” responses can thwart an attempted abduction. Nevertheless the first case and the one we dicussed in our December 20, 2011 Patient Safety Tip of the Week “Infant Abduction” demonstrate that the security bracelet systems are not infallible. All three cases illustrate the ease with which a potential abductor can get access to a maternity unit room, convince the mother that the infant (or mother) needs to be elsewhere, and get the infant into a bag of some type, and (maybe) be able to exit the hospital with that infant.
We had always had the impression that infant abductions were rare (and they are rare). When asked by an ob/gyn department to suggest a topic for a failure mode and effects analysis (FMEA) we recommended they look at preventing switched babies or switched breastmilk (see our November 17, 2009 Patient Safety Tip of the Week “Switched Babies”) because both are likely more common than infant abductions. The best statistics on infant abductions come from the National Center for Missing & Exploited Children (NCMEC 2012). Between 1983 and early 2012 there were 130 infant abductions from healthcare facilities (out of a total of 284 infant abductions). In all but 5 cases the missing infant was located and in most cases is unharmed, though there have been cases where the infant is found deceased. Most often the infant is abducted from the mother’s room. Compared to abductions from other sites, violence toward the mother (or caregiver) is infrequent in cases of abductions from healthcare facilities.
And even though infant abductions are relatively rare, such are sentinel events as far as the Joint Commission is concerned and “never” events in most states. Yes, you can do a root cause analysis (RCA) and implement preventive interventions after such an event. But the impact on the confidence your patients and community have in your organization is huge. Needless to say it may take years to overcome the negative publicity that accompanies such events. So now is a good time for hospitals to review their security programs and perhaps even consider doing a failure mode and effects analysis (FMEA) to determine their vulnerability. Most who read the case report in our December column found themselves saying “Wow, that could probably happen here!”.
Ever since Joint Commission issued a Sentinel Event Alert in 1999 (Joint Commission 1999) that identified root causes in cases of infant abductions from hospitals and made numerous recommendations for steps to prevent such most hospitals have put in place security systems, training and protocols to both prevent such abductions and respond immediately in the event of one. But the two cases here and the one we discussed back in December clearly highlight the potential vulnerabilities at all our hospitals (and even other healthcare facilities).
We don’t have any details on any root cause analyses that may have been done in the two recent cases but many of the root causes identified in last year’s case remain important.
Probably the most important issue to address is access to the maternity units. One is struck by the boldness of the abductors and how it can help them avoid suspicion. In the one case it appears that the abductor was presumed to be the sister of the mother by the nurse and to be a nurse’s aide by the mother. Neither apparently questioned who this person was. Apparently such boldness is typical. In another case example provided in the NCMEC resources (see below) an abductor posed as a social worker from another organization and all the family members assumed she was there to help them, while hospital staff assumed she was a family member.
Be especially wary to avoid “tailgating”. That is where an unauthorized person follows an authorized person through a door to a unit. If anyone tries to do that one must be sure they have an appropriate ID badge. If not, they need to explain to the person that access to this unit is restricted and make sure they do not enter. If they insist on entering you should immediately contact hospital security.
We suggest you observe some time how often unauthorized people access your maternity unit in a day. Alternatively, you might borrow from the “secret shopper” technique and see what happens if you send an unfamiliar person into your maternity unit.
Knowing all the entrance and exit points to your maternity unit is important. You also need to know what happens to those entrances and exits under all conditions. For example, do those locked exit doors open automatically when a code for a fire is announced? They probably do and a potential abductor may be aware of that.
The National Center for Missing & Exploited Children (NCMEC) provides some very good resources on preventing infant abductions. Among them is a profile of a typical abductor (based on analysis of over 250 cases). It is usually a female of child-bearing age who is often overweight (the latter often helps perpetuate the lie they are pregnant). The event is usually well-planned, though the actual target is more randomly selected by circumstances. The abductor often poses as a nurse or other healthcare worker. Visits to one or more hospitals to observe staff, workflows, routines, etc. are common.
So having a high level of awareness of people present on the maternity unit is critical. The NCMEC resource for healthcare workers lists many of the behaviors and questions that might help identify potential abductors.
Ensuring that all your staff wear appropriate identification badges is important. Having ID badges, perhaps color-coded, that indicate who works on the maternity unit is also a recommendation. The NCMEC even recommends periodically rotating the color-coding scheme.
But remember that your unit’s overall level of effective staffing is highly variable. Staffing is reduced at times of meal breaks or when there are unexpected absences due to illnesses. Moreover, on a busy day with several mothers in labor and maybe another needing an emergency C-section staff may be pulled in multiple directions and be focused less on the “visitors” to a unit.
Your staff must feel comfortable in challenging anyone they find suspicious. It can usually be done in a diplomatic way but they must be empowered to be more forceful. It is their obligation. You may recall a story in the past year about a well-known political figure getting into a tussle with nurses on a maternity unit. Well, those nurses were undoubtedly doing exactly what they were supposed to be doing to ensure the security on that maternity unit!
The NCMEC resources also note that diversions may be concocted to distract staff. They mention things like small fires in closets or loud arguments in waiting areas.
Infants may at times need to leave the maternity unit. They might have to go to radiology. Those getting circumcisions may go to the OR or a treatment room not on the unit. The NCMEC guideline also has good recommendations about who and what are considerations during hospital transports. Some of these are practical recommendations such as only transporting infants one at a time and requiring the infants be in bassinets during transports rather than being carried in arms.
Video surveillance systems may be helpful in deterring an attempt at abduction and in documenting an event and identifying the abductor and finding the abducted infant.
Education of both staff and the family are important in preventing infant abductions but should also be extended to help prevent incorrect identification of infants. When providing such education to mothers and family, it is important to assess their level of understanding. It is wise to do that education twice with the mother, once in the days or weeks just prior to anticipated delivery and then again immediately after delivery when the ID tags are being placed. You need to keep in mind that the mother’s cognition may be impaired by drugs used during labor and delivery and she may not fully comprehend what she is being told at that time. In any case, the identification process should be reinforced on every interaction between mother and baby and staff. The NCMEC makes available Safety Tips for Expectant Parents which provide great advice for expectant parents to read prior to coming to labor and delivery. The NCMEC resources also indicate that language barriers may be a risk factor.
Your staff training and retraining is very important. Everybody needs that training, not just your nursing and security staff. Hospital switchboard operators play a crucial role in “Code Pink” but are often afterthoughts in the training sessions. Also in our December 20, 2011 Patient Safety Tip of the Week “Infant Abduction” we noted you should also consider bringing non-employees into your training. For example, you might have contracted parking lot vendors or other contracted workers who might need to know how to respond (recall that in the case in our December column the key to finding the abductor was that the parking lot attendant wrote down the license plate number of a vehicle that left without paying for parking). And, of course, your local police should be part of your training as well as part of your drills.
Doing drills is also important. But you need to do them the right way. In our December 20, 2011 Patient Safety Tip of the Week “Infant Abduction” we noted that the hospital at which the abduction occurred had done 4 such “Code Pink” drills in the two prior years and that in each of those drills the “abductor” had been able to exit the facility. So when you do drills you need to be sure your observer/evaluators know what to look for. Then you need to be sure you follow up on items that need correction. The NCMEC resources for healthcare professionals includes a good drill critique form with a list of items to evaluate during drills and provides a good bibliography to other resources about doing drills. One item you would evaluate is whether during the “Code Pink” appropriate people were stopped and interrogated or prevented from exiting. Even though NCMEC has developed a profile of a typical abductor, we would caution against “profiling” during a Code Pink and recommend every person be considered a potential abductor. Also, given our comments about doors during fire alerts you might even consider doing a “Code Pink” drill immediately following a fire alert drill.
Doing a FMEA (failure mode and effects analysis) gets you to always consider “what if…?” scenarios to help you identify areas of vulnerability.
The whole point of a FMEA is to identify areas where unexpected circumstances might occur that could breach your safe processes.
Even if you don’t do a full formal FMEA on preventing infant abductions, it is worth becoming familiar with all the recommendations in the National Center for Missing & Exploited Children resources and the Joint Commission Sentinel Event Alert. Perhaps just developing a checklist of potential vulnerabilities and looking for them might be a starting point. NCMEC provides a self-assessment form on their resources page for healthcare professionals that serves as a good place to start.
The NCMEC guidelines also provide good advice for a critical incident response, too. Particularly helpful are their suggestions about how to deal with the family, public and media should an abduction occur (or even be attempted).
Also consider that the maternity unit may not be the only target for an infant abduction. Pediatric units, outpatient clinics, and other areas could also be potential targets so you should consider your potential vulnerabilities there as well.
First and foremost don’t get complacent! All too often we hear “that could never happen here” and people assume that the infant security bracelet system is failsafe. Well it’s not, as evidenced in the case from our December column and in the current case that occurred at a very respected maternity hospital.
And don’t forget our November 17, 2009 Patient Safety Tip of the Week “Switched Babies”. That deals with the equally serious potential problems of getting two newborns switched and misidentified and the problem of misidentifying expressed breastmilk and giving it to the wrong infants. Like infant abductions, these are relatively rare events but have serious consequences.
Mandak J. Teen charged with snatching baby from Pa. Hospital. Associated Press August 24, 2012
Mohajer ST/Associated Press. Woman to face kidnapping charge in alleged attempt to take newborn infant from Calif. hospital. StarTribune August 8, 2012
The Joint Commission. Sentinel Event Alert. Infant Abductions: Preventing Future Occurrences. Issue 9 April 9, 1999
NCMEC (National Center for Missing & Exploited Children). Infant Abduction Prevention and Resources.
NCMEC (National Center for Missing & Exploited Children). Infant Abduction Statistics. May 6, 2012
NCMEC (National Center for Missing & Exploited Children). Profile of a "Typical" Infant Abductor.
NCMEC and 5 other organizations. For Healthcare Professionals: Guidelines on Prevention of and Response to Infant Abductions. Ninth Edition 2009
NCMEC (National Center for Missing & Exploited Children). Safety Tips for Expectant Parents.
Print “More Infant Abductions”
September 11, 2012
In Search of the Ideal Early Warning Score
In multiple columns on rapid response teams (RRT’s) we’ve noted that the evidence for improved patient outcomes in response to RRT activation has been scant. And we’ve reiterated that the likely reason is not the performance of the RRT but rather the fact that we are recognizing the clinical deterioration of the patient too late. Multiple studies have demonstrated that most patients who suffer an in-hospital cardiac or respiratory arrest have had some deterioration of vital signs or other clinical signs at least 6-8 hours (and many longer) prior to the arrest. So for many years the search has been on for better ways to identify clinical deterioration earlier.
Intermittent vital sign recording is simply not good enough to identify such deterioration. All too often those vital signs are assessed at one point in time and potential trends not seen. Ironically, the switch from paper to electronic health records may have even further aggravated that problem since some of the EMR’s don’t provide easy access to a graphic flow chart similar to the paper vital signs flowchart that always sat on top of the patient chart. Add to that the fact that the way we take vital signs may alter the very vital signs we are assessing. In our numerous columns on opioid-related or oxygen-related respiratory depression we’ve pointed out that assessment of respiratory rate is particularly prone to error. That is the vital sign most often omitted. But also when you stimulate a person who is obtunded because of CO2 retention they may become alert and their respiratory rate actually increases. Yet respiratory rate abnormalities, when properly assessed, may be the best predictors of clinical deterioration.
And there are numerous problems with any threshold-based alarm systems (see our February 22, 2011 Patient Safety Tip of the Week “Rethinking Alarms”). In that column we highlighted a very insightful study by Lynn et al (Lynn 2011) that described many of the flaws in current patient monitoring systems, particularly those monitoring for respiratory complications. And we stressed the need for “smart” alarm systems that can monitor multiple parameters in an integrated fashion to detect deterioration earlier.
So many have attempted to develop “track and trigger” systems where physiological parameters are monitored in search of trends indicating clinical or physiological deterioration that merits assessment and intervention. Most recent research is focusing on using continuous monitoring of multiple parameters (physiological surveillance) but some older “early warning systems” (EWS) looked at multiple parameters collectively and tried to fit them into a “score” that would indicate deterioration and trigger a response.
Use of early warning scores (EWS) has never really caught on in the US. Yet we all agree that earlier recognition of clinical deterioration is critical and needs improvement (see our Patient Safety Tips of the Week for December 29, 2009 “Recognizing Deteriorating Patients”, March 15, 2011 “Early Warnings for Sepsis” and February 22, 2011 Patient Safety Tip of the Week “Rethinking Alarms”).
The problem with most early warning systems is that they may not have been validated, particularly for the setting or patient population where being used (Kyriacos 2011) and a paucity of randomized controlled trials or other high quality studies evaluating use of tools for the identification of deteriorating patients (CADTH 2011, Gao 2007). The predictive utilities may vary depending upon whether your population is in the ICU, general ward, or emergency department or whether the patient is a “medical” or “surgical” patient, etc. Another problem is that the individual parameters used may differ from system to system. They usually include some combination of respiratory rate, heart rate, blood pressure, and temperature but some include level of arousal, oxygen saturation, urine output, or nurses’ general perception regarding the patient. Weighting may be assigned to various parameters but this weighting may differ from system to system. And the aggregate score that should trigger a response may vary from system to system and study to study.
The modified early warning score (MEWS) is probably the best known of these tools designed to alert staff to early clinical deterioration. In our March 2012 What’s New in the Patient Safety World column “Value of an Expanded Early Warning System Score” we noted a study (Smith 2012) from the Netherlands that showed the impact of that score in predicting clinical deterioration in patients admitted to general or trauma surgery wards. The tool included the basic parameters included in earlier versions of the MEWS (heart rate, systolic BP, respiratory rate, oxygen saturation, temperature, and level of consciousness) but added some new parameters. One was urinary output. The other was a more subjective parameter: the nurse’s level of concern about the patient’s condition. Of 592 consecutive patients admitted to the general and trauma surgery wards of a level I trauma center 8% of patients met their composite outcome of death, reanimation (resuscitation), unexpected ICU admission, emergency operation, or severe complication. Patients reaching a score of 3 or higher on the expanded tool were 11 times more likely to meet the composite endpoint, even after adjustment for the ASA grade. The negative predictive value of the score was 97%, indicating its use as a screening tool is quite valuable. The sensitivity was 74% and the positive predictive value 26%.
Now the National Health Service in the UK, in partnership with the Royal College of Physicians and multiple other stakeholder organizations, has recently taken the unprecedented step of recommending all its hospitals use the national early warning score (NEWS) to assess patients and identify early clinical deterioration. The summary document describes all that went into development of the NEWS system. Those stakeholders recognized that there was great variation in the ways hospitals assessed patients for deterioration. They looked at multiple early warning scoring tools and determined that the NEWS was the best tool to standardize on. It was good at discriminating risk of acute mortality and more sensitive than most of the other tools. A great deal of training and education will go into implementation of the NEWS system and built in are plans for evaluation of its efficacy and refinement of its features.
The NEWS score is based on respiratory rate, temperature, heart rate, systolic blood pressure, oxygen saturation and level of consciousness. Each is scored from 0 to 3 and aggregated into a total score (2 additional points are added for those patients requiring oxygen). The recommended responses are stratified according to the score. A score of 5-6 (or a score of 3 on any of the individual items) should prompt an urgent review by a clinician and a score of 7 or higher should prompt an assessment by a team with critical care competencies. The NEWS resources downloadable from the Royal College of Physicians website are actually quite useful. To facilitate standardization and a national unified approach, NEWS uses a color-coded clinical observation chart to record and view all the variables and the total score.
This is really a grand experiment. They have basically taken away the great variation that had been present in and across hospitals and now have a standardized system on which they can base prospective outcome studies.
A clinical deterioration prediction tool for internal medicine patients has also recently been developed (Kirkland 2012). They did regression analysis on one population to derive a scoring system, then validated it retrospectively on another population. They found that the Braden Scale score, respiratory rate, oxygen saturation, and shock index were predictive of clinical deterioration 2 to 12 hours in the future. This makes good use of the Braden Scale, which most hospitals use to assess patient risk for decubiti. Interestingly, the Braden Scale score has also been recently shown to be predictive of complications in elderly patients undergoing surgery (Cohen 2012). These are good examples of using data that is already being collected to provide additional useful information.
Other studies looking at predicting which acute medical patients will need ICU care have found that tools such as PREEMPT-2 and PREAMBLE-2 outperformed other scoring systems (Carmichael 2011). Another recent study has shown it is feasible to use an EMR-based score to detect impending deterioration of patients who are not yet in intensive care (Escobar 2012).
Churpek and colleagues (Churpek 2012) looked at patients who had cardiac arrests on the wards and looked at predictability using both MEWS and other vital sign parameters. They found that on admission the scores were comparable to nested case controls. However, by 48 hours prior to cardiac arrest differences in these parameters compared to the controls were apparent. The maximum MEWS score was the best predictor, followed by the maximum respiratory rate, maximum heart rate, maximum pulse pressure index, and minimum diastolic blood pressure. They conclude that the MEWS does significantly differ between cardiac arrest patients and controls by 48 hours prior to the event but that the MEWS contains some poor predictors (temperature) and omits significant predictors such as diastolic blood pressure and pulse pressure index.
MEWS has also been used to predict mortality in some circumstances. But some studies have suggested that the Simple Clinical Score (SCS) or the Rapid Emergency Medicine Score (REMS) are better at predicting mortality in patients with sepsis in general internal medicine departments (Ghanem-Zoubi 2011).
In addition to being valid and reliable, a good physiological monitoring system should fit into workflows and notify healthcare workers of the need to respond with minimal interruptions and distractions for “false alarms”. Some of the newer physiological monitoring systems (Taenzer 2011) have addressed the alarm fatigue issue by developing a balance between sensitivity and specificity. But the other critical characteristic is including a short delay into the notification phase of the response system. These features are typically compromises that may lead to failure to recognize some cases of deterioration immediately but overall leads to fewer false alarms and fewer unnecessary interruptions that might detract from other nursing care and less alarm fatigue. Those authors had previously shown that a patient surveillance system based on continuous pulse oximetry with nursing notification of violation of alarm limits via wireless pager successfully reduced both rescue event rates and ICU transfers (Taenzer 2010). A built-in delay in the nurse notification eliminated many of the transient and motion artifact-generated false alarms.
All these studies demonstrate that it should be possible through physiological monitoring and track and trigger systems to identify patients at greatest risk for deterioration considerably earlier than we have in the past (and hopefully tailor interventions to prevent further deterioration). Given the increasing sophistication of physiologic monitoring systems and integration with the electronic medical record we have little doubt that in the near future we will have systems in place, often running in the background, that solve the elusive problem of early detection of clinical deterioration.
Some of our other columns on MEWS or recognition of clinical deterioration:
Lynn LA, Curry JP. Patterns of unexpected in-hospital deaths: a root cause analysis. Patient Safety in Surgery 2011, 5:3 (11 February 2011)
Kyriacos U, Jelsma J, Jordan S. Monitoring vital signs using early warning scoring systems: a review of the literature. Journal of Nursing Management 2011; 19(3): 311–330
CADTH (Canadian Agency for Drugs and Technology in Health). Tools for the Early Identification of Adult Inpatients at Risk for Deterioration: Clinical Evidence and Guidelines. 22 November 2011
Gao H, McDonnell A, Harrison DA, et al. Systematic review and evaluation of physiological track and trigger warning systems for identifying at-risk patients on the ward. Intensive Care Medicine 2007; 33(4): 667 – 679
Smith T, Den Hartog D, Moerman T, et al. Accuracy of an expanded early warning score for patients in general and trauma surgery wards. British Journal of Surgery 2012; 99: 192-197
Royal College of Physicians (UK). National Early Warning Score (NEWS). Standardising the assessment of acute-illness severity in the NHS. July 2012
Royal College of Physicians. National Early Warning Score (NEWS): Standardising the assessment of acuteillness severity in the NHS. Report of a working party. London: RCP, 2012
color coded chart
Observation chart for the National Early Warning Score (NEWS)
National Early Warning Score (NEWS)
The scoring system
The National Early Warning Score (NEWS) thresholds and triggers
Clinical response to NEWS triggers
Kirkland LL, Malinchoc M, O'Byrne M, et al. A Clinical Deterioration Prediction Tool for Internal Medicine Patients. American Journal of Medical Quality 2012; 1062860612450459, first published on July 19, 2012 as doi:10.1177/1062860612450459
Cohen R-R, Lagoo-Deenadayalan SA, Heflin MT, et al. Exploring Predictors of Complication in Older Surgical Patients: A Deficit Accumulation Index and the Braden Scale. J Am Geriatr Soc 2012; Early View Article first published online: 20 Aug 2012
Carmichael HA, Robertson E, Austin J, et al. A new approach to scoring systems to improve identification of acute medical admissions that will require critical care. Scott Med J 2011; 56: 195-202
Escobar GJ, LaGuardia JC, Turk BJ, et al. Early detection of impending physiologic deterioration among patients who are not in intensive care: Development of predictive models using data from an automated electronic medical record. J Hosp Med 2012; 7(5): 388–395
Article first published online: 22 MAR 2012
Churpek MM, Yuen TC, Huber MT, Park SY, Hall JB, Edelson DP. Predicting Cardiac Arrest on the Wards: A Nested Case-Control Study. Chest 2012; 141(5): 1170-1176
Ghanem-Zoubi NO, Vardi M, Laor A, Weber G, Bitterman H. Assessment of disease-severity scoring systems for patients with sepsis in general internal medicine departments. Critical Care 2011, 15: R95 (14 March 2011)
Taenzer, Andreas H.; Pyke, Joshua B.; McGrath, Susan P. A Review of Current and Emerging Approaches to Address Failure-to-Rescue. Anesthesiology 2011; 115(2): 421-431
Taenzer AH, Pyke JB, McGrath SP, Blike GT: Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: A before-and-after concurrence study. Anesthesiology 2010; 112: 282–7
September 18, 2012
Insulin Pump Safety
Problems related to insulin pumps have been on our list of potential topics for some time. We’ve discussed infusion pump safety issues in general (see our April 27, 2010 Patient Safety Tip of the Week “Infusion Pump Safety”) but that dealt more with the various infusion pumps used in the hospital setting and did not focus on insulin pumps. But it took a description of an untoward event recently published by the California Department of Public Health (CDHP 2012) to remind us to do this column. That was an unfortunate case where a diabetic patient who used an insulin pump was admitted to a hospital with pyelonephritis and was given insulin by injections per a sliding scale regimen, with numerous caregivers assuming that the insulin pump had been turned off. The patient was later found unconscious with profound hypoglycemia and ultimately died. It was suspected that she was receiving both the insulin injections and insulin via her insulin pump.
Most hospitals, including the one in the above case, have policies on bedside storage of a patient’s own medications or self-administration of such medications by inpatients. Generally they require involvement by a pharmacist, oversight of storage of the medications, and perhaps integration into the hospital’s barcoding/bedside medication verification (BMV) system. (As an aside, note that the Pennsylvania Patient Safety Authority (Grissinger 2012) recently did a very good review on patients taking their own medications while hospitalized.) However, many such policies do not specifically address insulin pumps. The policy at the above hospital did not address them.
The plan of correction by the above hospital included temporarily disallowing use of insulin pumps until they were able to put in place a much more complete solution. They revised their policy on self-administered medications at the bedside to specifically address insulin pumps. If there was an alternate insulin regimen ordered by a physician, the insulin pump was to be removed from the room. It would no longer be allowed to simply tell the patient to turn the pump off. In addition, an endocrinologist would be required to provide an assessment of such patients. They did extensive staff training on insulin pumps (with development of competencies) and attempted to cohort patients with insulin pumps to one unit. In addition, Pharmacy would be involved in the care of any patient with an insulin pump.
A recent review of insulin pump therapy (Pickup 2012) discusses issues related to hospitalization. It recognizes that hospital staff are frequently inexperienced in dealing with insulin pumps and notes that most patients using insulin pumps as outpatients do prefer to continue with their pump therapy while an inpatient. The author recommends advice from the local insulin pump team and adherence to strict insulin pump protocols.
The group at the Mayo Clinic Scottsdale (Leonhardi 2008, Nassar 2010) has good experience with use of insulin pumps in hospitalized patients. They developed a policy and protocols for managing patients with insulin pumps who get hospitalized (Leonhardi 2008). They, too, note that most of their patients on insulin pumps wish to continue self-administration of insulin via insulin pump while hospitalized. However, hospital staff are often unfamiliar with use of the pumps and hospitals often lack supplies compatible with the pump systems. So they developed their program with 2 goals in mind: (1) maintain flexibility in allowing patients to continue use of their insulin pumps in hospital and (2) ensure patient safety. They developed a formal written policy for their hospital (available in the Leonhardi 2008 paper). It includes a list of contraindications to continued use of the pump in the hospital and a set of rules to guide the medical staff about insulin pump management. It includes requirement for identification of the pump, brand of pump and insulin type. The patient must sign a consent to continue the pump in the hospital and the physician uses a standardized order set (pre-printed or via CPOE). Consults by an endocrinologist, diabetes educator and nutritionist are required. An insulin pump/glucose monitoring flowsheet is kept at the bedside. The consent form requires the patient to bring their own pump supplies with them. (The Leonhardi 2008 paper also includes copies of the consent form, the order set, and the flowsheet.) Both papers summarize the experience with hospitalizations using these but we’ll just use the latter one since it has the most recent experience (Nassar 2010). There were 125 hospitalizations in 65 patients with insulin pumps and the insulin pump was able to be continued in two thirds during hospitalizations. Compliance with most elements of the policy was generally good. Consent agreements were signed in 83% of those continuing to use the pump in hospital and the order sets were used in 89%. Endocrinology consults were obtained in 89% and there was nursing documentation of the pump insertion sites in 89%. However, the bedside insulin pump flow sheets were found in only 55% (though this may reflect failure to scan these documents into the medical record). The mean glucose during the hospitalization did not differ between groups continuing the pump compared to those in which it was discontinued or used only intermittently. Other than one instance of a pump catheter kinking there were no other adverse events related to the pump therapy. Frequency of hypoglycemia was comparable in the “pump on” and “pump off” groups but slightly higher in the “intermittent pump” group.
The Mayo Scottsdale experience clearly demonstrates that it is feasible and safe to allow continuation of the insulin pump therapy during inpatient hospitalizations. Patients seem to like that. But it remains to be seen that this results in any better management of glycemia than one sees with conventional inpatient glycemia management. The authors had expected to see less frequent hypoglycemic events in the pump patients but this failed to be demonstrated. But if you are considering letting patients on the pump continue it in hospital, they have provided for you a great policy and set of documents to start with!
The biggest challenge the Mayo Scottsdale group noted was continually educating the staff. Not only is there nursing staff turnover but as an academic setting they also deal with new housestaff regularly. Good insulin pump programs provide extensive education and training not only for the patient but also for their families or caregivers. (Note that some of the deaths reported to the FDA in patients on insulin pumps occurred in settings where there was no caregiver available.) So would you provide any less education and training to your hospital staff? It might be impractical to provide the many hours of training needed to an entire hospital staff. So that is where the concept of cohorting pump patients on one unit might make sense. That would decrease the number of individuals who would need extensive training. But there is always the possibility that such units might need a “floater” or “temporary” nurse and you’d have to be sure they had the competencies for managing patients on the pump.
Another group found similar challenges in educating staff about the use of insulin pumps in hospitalized patients (Buchko 2012). In their early implementation of a quality improvement program on insulin pump use, in which the nursing educational program was not mandatory, they found few nurses completed the computer-based training and compliance with recommended practices were suboptimal and glycemic management was not improved. They subsequently enhanced the educational program for both nurses and physicians. In addition, they added daily rounds by 2 advanced practice nurses who were part of their multidisciplinary team to maintain constant vigilance of patients using the insulin pump. One of their key roles was to ensure that the patient was still capable of self-management at all times. We consider that latter point as critical. While patients may be alert and cognitively and physically capable of self-management of their insulin pump on admission, it is not uncommon to see deterioration of either capability during a hospitalization. Therefore, the type of daily surveillance implemented in the Buchko study makes great sense. And, indeed, they found significant improvement in their late implementation phase for both compliance with process metrics and glycemic control.
The Mayo Scottsdale team has also developed standard guidelines and a checklist for continuation of the insulin pump in the perioperative period (Boyle 2012). A sample set of protocols is summarized in the article. They had noted inconsistent documentation of pump use and glucose monitoring throughout the perioperative period, even for patients with prolonged anesthesia and recovery times, and it was often unclear whether the pump was in place and operational during the intraoperative period (Nassar 2012). Hence, they recommended development of guidelines for use of the pump in patients undergoing surgery and throughout the perioperative period.
But there are probably “little” issues that could have a big impact. If your policy specifies that patients bring in their own insulin pump supplies does that mean just the infusion set and catheters? What about battery replacements? Do nursing staff know what to do if the “low battery” alarm goes off?
And bigger issues. What if you don’t have an insulin pump team? Or even an endocrinologist? Even a small rural hospital that has no local patients on insulin pumps may from time to time get a pump patient who is visiting the area or passing through and develops a medical problem requiring hospitalization. In such cases, it is probably wisest to disconnect the pump and use alternative insulin regimens. However, those hospitals lacking pump expertise might consider developing telemedicine linkages to larger urban systems that do have endocrinologists and formal insulin pump teams. Or consider contacting the physician or insulin pump team from the patient’s home area.
One other problem we are seeing more and more is related to use of insulin U-500 preparations. Problems related to the insulin U-500 preparation are well known and include the issues of use of incorrect syringes, mistaken identity of U-500 vials for standard concentration vials, selection errors from computerized order entry screens, etc. (PPSA 2010, ISMP 2007). Because there are many problems associated with the use of that preparation many hospitals don’t even stock it. But patients on insulin pumps sometimes are using that preparation. When they get hospitalized, the hospital personnel often attempt to convert the patient to an equivalent dose of a different insulin preparation. Errors are often made during that conversion. However, just as likely are errors made at discharge when the conversion back to the U-500 preparation should be done.
The review by Pickup (Pickup 2012) has a good discussion of the indications and patient selection for using the insulin pump. Note that he recommends patients on insulin pumps should be managed by formal specialized insulin pump teams consisting of a physician, diabetes nurse, and a dietitian trained in pump procedures. He does not recommend initiation of insulin pumps by primary care physicians. The patient must be motivated and committed to frequent glucose self-monitoring, carbohydrate counting, and working with the team to learn pump procedures.
Adolescents represent an age group with some unique challenges. After the FDA received reports of 5 deaths in adolescents in one year related to insulin pumps they did a comprehensive review of cases identified in the MAUDE database over a 10-year period (Cope 2008). Over that time there were 1594 reports of events related to insulin pumps in patients aged 12-21, including 13 deaths. In half the cases, excess administration of insulin occurred. Factors common in adolescence that may have contributed in some cases were related to compliance, education, sports-related activities, and dropping or damaging the pumps. In some cases tampering or intentional overdose (eg. suicide attempt) occurred. They refer to one study that showed a substantial disparity between the number of adolescents claiming they were compliant with their pump use and actual compliance.
The FDA also recently addressed contributing factors to insulin pump errors in children, adolescents and adults (Clayton-Jeter 2012). Though many factors are common to all age groups, there are some that are unique to adolescents. Their review stressed the importance of patient selection (including assessment of motivation, the level of maturity, psychological and behavioral factors, and cognitive abilities) plus education and training and level of support from other caregivers. They note that peer-related activities may play a role in noncompliance with the pump. An example they note some teens expressed a desire to disconnect the pump when they wanted to get in a hot tub or pool beyond the recommended time limit.
The FDA has sponsored at least two insulin pump safety meetings (Klonoff 2009, Zhang 2010a) and done a hazard analysis on a generic insulin infusion pump model (Zhang 2010b). These have identified numerous areas in need of improvement (design, hardware, software, human factors, alarms, communication issues, displays, etc). Other investigations have even found that some systems might be vulnerable to hacking (Finkle 2011).
Another issue that hospitals (and freestanding imaging units) must deal with is the risk associated with insulin pumps in patients who need to undergo MRI. The risks and the appropriate measures to reduce or avoid those risks depend on the design, construction, and type of insulin pump (Shellock 2010). The very strong electromagnetic fields generated by MRI machines can interfere with the insulin delivery system and can even permanently damage the pump’s motor. In addition, the infusion sets from some manufacturers may also contain ferromagnetic elements (such as a steel surgical needle) that would need to be removed before any MRI study. The Shellock article lists information about the most commonly used insulin pump systems. In most cases the unit must be removed prior to the patient being taken into the MRI room. In cases where a patient with an insulin pump is inadvertently exposed to an MRI it is usually recommended that the pump be immediately disconnected and the manufacturer contacted for instructions. The Shellock article also advises the healthcare professional to contact the manufacturer ahead of time in each individual instance to get the most up-to-date safety information.
Insulin pump therapy has made a major impact on the lives and health of many diabetic patients. It has improved glycemia control and lowered HbA1c levels, reduced hypoglycemic episodes, and improved several indicators of patient quality of life. So the insulin pump is here to stay. It’s advisable for healthcare systems to develop teams to manage patients on insulin pumps and to develop protocols and procedures for those patients on insulin pumps who are hospitalized.
CDPH (California Department of Public Health). Statement of Deficiencies/Plan of Correction. Insulin Pump case. Accepted 4/6/2011. Published August 2012
Grissinger M. Patients Taking Their Own Medications While in the Hospital Pa Patient Saf Advis 2012; 9(2): 50-7
Pickup JC. Insulin-Pump Therapy for Type 1 Diabetes Mellitus. NEJM 2012; 366(17): 1616-1624
Leonhardi BJ, Boyle ME, Beer KA, Seifert KM, Bailey M, Miller-Cage V, Castro JC, Bourgeois PB, Cook CB. Use of continuous subcutaneous insulin infusion (insulin pump) therapy in the hospital: a review of one institution's experience. J Diabetes Sci Technol 2008; 2(6): 948–962
Nassar AA, Partlow BJ, Boyle ME, Castro JC, Bourgeois PB, Cook CB. Outpatient-to-Inpatient Transition of Insulin Pump Therapy: Successes and Continuing Challenges. J Diabetes Sci Technol 2010; 4(4): 863–872. Published online 2010 July 1.
Buchko BL, Artz B, Dayhoff S, March KS. Improving Care of Patients With Insulin Pumps During Hospitalization: Translating the Evidence. Journal of Nursing Care Quality 2012; 27(4): 333-340, October/December 2012
Boyle ME, Seifert KM, Beer KA, et al. Guidelines for application of continuous subcutaneous insulin infusion (insulin pump) therapy in the perioperative period. J Diabetes Sci Technol. 2012 Jan 1;6(1):184-90
Nassar AA, Boyle ME, Seifert KM, et al. Insulin pump therapy in patients with diabetes undergoing surgery. Endocr Pract. 2012; 18(1): 49-55
PPSA (Pennsylvania Patient Safety Authority). Medication Errors with the Dosing of Insulin: Problems across the Continuum. Pa Patient Saf Advis 2010; 7(1): 9-17
ISMP (Institute for Safe Medication Practices). HUMULIN R CONCENTRATE U-500. ISMP Medication Safety Alert Community/Ambulatory Care Edition. 2007; August 2007
Cope JU, Morrison AE, Samuels-Reid J. Adolescent use of insulin and patient-controlled analgesia pump technology: a 10-year Food and Drug Administration retrospective study of adverse events. Pediatrics 2008; 121(5): e1133 -e1138
Clayton-Jeter H. Contributing Factors to Insulin Pump Errors in Children, Adolescents and Adults. FDA Articles of Interest for Health Professionals (March 2012)
Klonoff DC, Reyes JS. Insulin Pump Safety Meeting: Summary Report. J Diabetes Sci Technol. 2009 March; 3(2): 396–402.
Zhang Y, Jones PL, Klonoff DC. Second Insulin Pump Safety Meeting: Summary Report. J Diabetes Sci Technol. 2010; 4(2): 488–493 Published online 2010 March 1.
Zhang Y, Jones PL, Jetley R. A Hazard Analysis for a Generic Insulin Infusion Pump. Journal of Diabetes Science and Technology 2010; 4(2): 263-283 March 2010
Finkle J. Exclusive: Medtronic probes insulin pump risks. Reuters 2011; October 26, 2011
Shellock FG. MRI safety: Patients with insulin pumps require special cautions. Diagnostic Imaging October 5, 2010
Print “Insulin Pump Safety”
September 25, 2012
Preoperative Assessment for Geriatric Patients
We have long been advocates of major change in the way we prepare patients, particularly the elderly, for surgery (see our August 17, 2010 Patient Safety Tip of the Week “Preoperative Consultation – Time to Change” and the multiple columns listed at the end of this column). We’ve also done multiple columns on the ability of measures of frailty to predict postoperative complications, morbidity and mortality, and discharge to institutional settings. And multiple columns on the risk factors for post-operative delirium. And numerous columns on the risk factors for postoperative opioid-related respiratory depression and identifying patients at risk for sleep apnea.
The American College of Surgeons and the American Geriatrics Society, in collaboration with numerous other constituents, have come together to publish a new guideline on the preoperative assessment for geriatric patients anticipating surgery (Chow 2012). This is a much needed guideline and addresses all the important issues we’ve raised above.
The guideline includes a Checklist for the Optimal Preoperative Assessment of the Geriatric Surgical Patient with the following recommendations:
The guideline recommends cognitive assessment using the Mini-Cog (see our August 7, 2012 Patient Safety Tip of the Week “Cognition, Post-Op Delirium, and Post-Op Outcomes”) and has a good discussion about the legal requirements for assessing a patient’s capacity to consent. It recommends screening for depression with the PHQ-2 tool and if either question is answered “yes” it recommends referral to a primary care physician, geriatrician, or mental health specialist.
The guideline has a nice table of risk factors for postoperative delirium and for patients at risk for postoperative delirium the guideline recommends avoiding benzodiazepines and antihistamines.
The guideline suggests using a tool like the CAGE tool to screen for alcohol and substance abuse. It recommends following the ACC/AHA algorithm for evaluating cardiac risk. The guideline has a table of risk factors for postoperative pulmonary complications, separated into patient-related risk factors and surgery-related risk factors. It also has a table for pre-op strategies to reduce the risk for postoperative pulmonary complications.
The sections on assessing functional status, gait/mobility, and fall risk recommend assessing activities of daily living, doing the Timed Up and Go Test (TUGT), and assessing for fall risk factors. The discussion on frailty addresses most of the issues we discussed in our prior columns on frailty and surgical risk (see our November 2011 What’s New in the Patient Safety World column “Timed Up-and-Go Test and Surgical Outcomes” and our August 9, 2011 Patient Safety Tip of the Week “Frailty and the Surgical Patient” and our August 14, 2012 Patient Safety Tip of the Week“Gait Speed: A New Vital Sign?”). They highlight the contributions by Makary and colleagues (Makary et al 2010) and Robinson and colleagues in predicting postoperative complications based on frailty measures (Robinson 2009, Robinson 2011).
A nutritional status evaluation should include calculation of the BMI, a serum albumin level, and assessment for unintentional weight loss within the past 6 months. It has recommendations for both preoperative and perioperative nutritional support for those patients deemed at risk.
The section on medication management is excellent. In addition to addressing polypharmacy and drugs on Beers’ list, it discusses ACC/AHA guidelines for perioperative use of beta-blockers and statins, and adjusting medication doses as appropriate for the patient’s level of renal function.
The section on preoperative testing is also excellent. The overriding message is that “routine” testing is of little value and any preoperative tests should be individualized for the patient’s risks.
Lastly, the section on patient counseling is excellent. It emphasizes the need for advance directives and designation of a health care proxy and all such documents should be in the patient’s medical record. But it goes much further and discusses the need for the surgeon to take into account the patient’s preferences and expectations. The discussion must include potential complications and the possibility of functional or cognitive decline and potential need for rehabilitation or long term care. Assessing the patient’s family and social support systems should involve a social worker when indicated.
Overall, we really like this guideline. It is both comprehensive and practical and emphasizes the big picture, focusing on functional status and simple assessments rather than taking the “shotgun” approach to preoperative testing that we still see so commonly used. It is well thought out and has an excellent bibliography (117 references).
We’ve also seen several other good articles this year on preoperative assessment of patient’s about to undergo surgery. These have included the pre-op anesthesia evaluation (ASA 2012) and the pre-op medical consultation (Rivera 2012). Both concur that preoperative tests ordered on asymptomatic patients or patients lacking a specific indication do not contribute significantly to the management of the patient and should not be routinely ordered. The updated Practice Advisory for Preanesthesia Evaluation (ASA 2012) does discuss in what context various preoperative tests are indicated.
Rivera and colleagues (Rivera 2012) discuss some of the medication management issues pertinent to the preoperative medical consultation. In discussing the need to continue beta blocker therapy in patients previously on beta blockers, they suggest the consultation be done with sufficient time to allow for gradual titration of the beta blocker dose if indicated. They also have good recommendations regarding management of statins, antiplatelet agents, anticoagulants, antidepressants, antipsychotic agents, benzodiazepines, neurologic medications, and herbal medications.
Neither of the latter two articles focuses on functional status, cognitive issues or frailty. But they do complement the excellent job Chow and colleagues have done in the new ACS/AGS guideline on the preoperative assessment for geriatric patients anticipating surgery (Chow 2012). Use all three as valuable resources in preparing your elderly patients for surgery.
Some of our prior columns on preoperative assessment:
Chow WB, Rosenthal RA, Merkow RP, et al. Optimal Preoperative Assessment of the Geriatric Surgical Patient: A Best Practices Guideline from the American College of Surgeons National Surgical Quality Improvement Program and the American Geriatrics Society. Journal of the American College of Surgeons 2012; 215(4): 453-466, October 2012
Makary MA, Segeve DL, Pronovost PJ, et al. Frailty as a Predictor of Surgical Outcomes in Older Patients. Journal of the American College of Surgeons 2010; 210(6): 901-908, June 2010
Robinson TN, Eiseman B, Wallace JI, et al. Redefining Geriatric Preoperative Assessment Using Frailty, Disability and Co-Morbidity. Annals of Surgery 2009; 250(3): 449-455, September 2009
Robinson TN, Wallace JI, Wu DS, et al. Accumulated Frailty Characteristics Predict Postoperative Discharge Institutionalization in the Geriatric Patient. J Am Coll Surg 2011; 213(1): 37-42, July 2011
ASA (American Society of Anesthesiologists) Committee on Standards and Practice ParametersASA. Practice Advisory for Preanesthesia Evaluation: An Updated Report by the American Society of Anesthesiologists Task Force on Preanesthesia Evaluation. Anesthesiology 2012; 116(3): 522-538, March 2012
Rivera RA, Nguyen MT, Martinez-Osorio JI, et al. Preoperative medical consultation: maximizing its benefits. Am J Surg 2012; ahead of print July 9, 2012
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