Healthcare Consulting Services
October 4, 2016
More on After-Hours Surgery
The “weekend effect” (sometimes also known as the “after hours effect” since many of the same results apply to patients admitted at night as well as on weekends) in which increases in mortality, complications or adverse events are seen for patients admitted on weekends has been demonstrated for a wide range of both surgical and medical conditions. Our numerous columns on the “weekend effect” have stressed that there are likely both patient-related and system-related factors underlying the phenomenon (see, for example, our November 2013 What's New in the Patient Safety World column “The Weekend Effect: Not One Simple Answer”).
Our June 2016 What's New in the Patient Safety World column “Weekend Effect Challenged” noted several recent articles have challenged the concept of the “weekend effect” and pointed out deficiencies in case identification methodologies that may give rise to inaccurate conclusions. But a couple new studies demonstrate both a “weekend effect” and an “after hours” effect for surgery, though the weekend effect may have been reduced somewhat in recent years.
A study from the UK showed that the “weekend effect” for emergency general surgery has improved over the past 15 years (McCallum 2016). The researchers showed that the 30-day mortality rate is indeed higher for patients having surgery on Saturdays and Sundays, compared to weekdays. But there was no difference in 30-day mortality by day of the week admitted. Moreover, for those surgeries done on the weekend the 30-day mortality rates have decreased from 5.4% in 2000-2004 to 2.9% in 2010-2014.
On the other hand, Canadian researchers showed that surgical mortality does vary by time of day (WFSA 2016). They evaluated all surgical procedures for the past 5 years, including all elective and emergent surgical cases except ophthalmic and local anesthesia cases. After adjustment for age and ASA scores, patients operated at night (11:30 PM-7:29 AM) were 2.17 times more likely to die within 30 days than those operating on during regular daytime working hours (7:30 AM-3:29 PM). Those operated on in the late day (3:30 PM-11:29 PM) were 1.43 times more likely to die than those operated on during regular daytime working hours.
Of course, it is logical that patients operated on after-hours are likely to be sicker and thus have a higher mortality. The Canadian authors tried to adjust for that using age and ASA scores but those likely are imperfect adjusters. Other potential factors contributing to the higher after-hours mortality as noted by the authors include provider fatigue during anesthesia and surgery, overnight hospital staffing issues, delays in treatment, or the patient being too sick to be postponed prior to treatment.
We’ve done several prior columns pointing out some of the downsides of after-hours surgery. In our What's New in the Patient Safety World columns for September 2009 “After-Hours Surgery – Is There a Downside?” and October 2014 “What Time of Day Do You Want Your Surgery?” we discussed studies that showed for certain types of orthopedic surgery after hours there was an increased need for reoperations for removal of painful fracture hardware (Ricci 2009) and laparoscopic cholecystectomies done at night compared to daytime were associated with a higher conversion rate to open cholecystectomy (11% vs 6%) (Wu 2014). We also noted previous studies by Kelz and colleagues that showed increased morbidity in non-emergent surgical cases done “after hours”, one in the VA system (Kelz 2008) and another in a private hospital setting (Kelz 2009). And our January 2015 What's New in the Patient Safety World column “Emergency Surgery Also Very Costly” suggested, in addition to the human costs of after-hours surgery there may also be financial costs.
Why should “after hours” surgery be more prone to adverse outcomes than regularly scheduled elective surgery? There are many reasons aside from the fact that patients needing emergency and after hours surgery are generally sicker. For surgery, in particular, the impact of time of day on teamwork is important. You are often operating with a team that is likely different from your daytime team. All members of that team (physicians, nurses, anesthesiologists, techs, etc.) may not have the same level of expertise or experience as your regular daytime team (because many hospitals have “seniority” policies, you may have less experienced personnel on your OR “on-call” teams) and the team dynamics between members is likely to be different. The post-surgery recovery unit is likely to be staffed much differently after-hours as well. The staff may be more likely to be unfamiliar with things like location of equipment. And some of the other hospital support services (eg. radiology, laboratory, sterile processing, etc.) may have lesser staffing after-hours. Just as importantly, many or all of the “on-call” staff that make up the after-hours surgical team have likely worked a full daytime shift that day so fatigue enters as a potential contributory factor. And there are always time pressures after hours as well. In addition, one of the most compelling reasons surgery is done at night rather than deferred to the next morning is the schedule of the surgeon or other physician for that next morning (either in surgery or the cath lab or his/her office). Because the surgeon does not want to disrupt that next day schedule, he/she often prefers to go ahead with the current case at night. Similarly, many hospitals run very tight OR schedules and adding a case from the previous night can disrupt the schedule of many other cases.
We highly recommend hospitals take a hard look at surgical cases done “after hours”. You need to look at the morbidity and mortality statistics of such cases. In particular, you need to determine which cases truly needed to be done after hours and, perhaps more importantly, which ones could have and should have been done during “regular hours”. If the latter are significant, you need to consider system changes such as reserving some “regular hours” for such cases to be done the following morning. You may have to alter the scheduling of cases for individual surgeons as well. For example, perhaps the surgeon on-call tonight should not have elective cases scheduled tomorrow morning. That way, if a case comes in tonight that should be done tomorrow morning you will have both a “free” OR room and a “free” surgeon. And you would need to develop a list of criteria to help you triage cases into “regular” or “after-hours” time slots.
Some of our previous columns on the “after-hours” surgery:
Some of our previous columns on the “weekend effect”:
McCallum IJD, McLean RC, Dixon S, O'Loughlin P. Retrospective analysis of 30-day mortality for emergency general surgery admissions evaluating the weekend effect. British Journal of Surgery 2016; 12 Aug 2016
WFSA (World Federation of Societies of Anaesthesiologists). Five-year study reveals patients operated on at night twice as likely to die as patients who have daytime operations. Science Daily 2016; August 29, 2016
Wang N, et al. Retrospective analysis of time of day of surgery and its 30 day in-hospital postoperative mortality rate at a single Canadian institution. Poster presentation 601. World Congress of Anaesthesiologists 2016
Ricci WM, Gallagher B, Brandt A, Schwappach J, Tucker M, Leighton R. Is After-Hours Orthopaedic Surgery Associated with Adverse Outcomes? A Prospective Comparative Study. J Bone Joint Surg Am. 2009; 91: 2067-2072
Wu JX, Nguyen AT, de Virgilio C, et al. Can it wait until morning? A comparison of nighttime versus daytime cholecystectomy for acute cholecystitis. Amer J Surg 2014; published online first September 20, 2014
Kelz, R.R., Freeman, K.M., Hosokawa, P.W. et al. Time of day is associated with postoperative morbidity: an analysis of the national surgical quality improvement program data. Annals of Surgery 2008; 247: 544–552
Kelz RR, Tran TT, Hosokawa P, et al. Time-of-day effects on surgical outcomes in the private sector: a retrospective cohort study. J Am Coll Surg 2009; 209(4): 434-445.e2.
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October 11, 2016
New Guideline on Preop Screening and Assessment for OSA
Our regular readers are well aware of the numerous controversies and limited evidence base regarding perioperative issues in patients with known obstructive sleep apnea (OSA) or those suspected as being at high risk for OSA (see the list of prior columns at the end of today’s column).
The Society of Anesthesia and Sleep Medicine has just published “Guidelines on Preoperative Screening and Assessment of Adult Patients with Obstructive Sleep Apnea”
(Chung 2016). This is a most thorough evaluation of the evidence base regarding multiple issues related to OSA in patients about to undergo surgery. One is struck by the lack of strong evidence for almost all the recommendations in the guideline, though we are not surprised since we’ve previously discussed most of the controversial issues. Yet this consensus guideline uses common sense and is very practical and appropriately balances concerns for patient safety with utilization of resources and concerns over timing of surgery.
Below is their executive summary of the recommendations:
Though this guideline deals primarily with the preoperative issues and does not delve into the many intra- and post-operative issues in patients with known or suspected OSA, this is a valuable document with lots of great references. Note also that a podcast about the guideline is available via the Anesthesia &Analgesia website as well.
A new meta-analysis confirms the utility of the pre-op STOP-Bang questionnaire in predicting complications following surgery (Nagappa 2016). From studies in the literature they found 11 qualified studies with over 20,000 adult patients who underwent surgery. Compared to those with a pre-op STOP-Bang score of 0-2, those with a score of 3 or more had an almost 4 times higher risk of complications (OR = 3.83). But, while OSA may be responsible for many of those complications, don’t forget that many of the STOP-Bang items by themselves (high BMI, hypertension, large neck circumference, age >50) may be associated with higher risks of surgical complications. Nevertheless, just knowing that such patients are at greater risk for complications should make staff more vigilant after surgery. They should be especially vigilant for signs of OSA and, as noted in the new Society of Anesthesia and Sleep Medicine guideline above, PAP therapy should be considered on a case-by-case basis even though the jury is still out on routine use of PAP in patients with undiagnosed but suspected OSA.
Our June 7, 2016 Patient Safety Tip of the Week “CPAP for Hospitalized Patients at High Risk for OSA” highlighted a study (Sharma 2016) which used the STOP tool to screen obese patients (BMI ≥ 30 kg/m2) admitted to select medical (non-surgical) services and sorted them into high- and low-risk for OSA groups. They found that rapid response system (RRS) activations were significantly more frequent in those patients in the high-risk group. But high-risk patients who were put on PAP (CPAP, BiPAP, or APAP) and were compliant with PAP were significantly less likely to have RRS activations than those high-risk patients not compliant with PAP or not receiving PAP. The study also implies (but does not actually include the data) that those patients compliant with PAP had lower mean LOS.
But perhaps the most important message is that patients identified at higher risk by the STOP-Bang questionnaire need closer postoperative monitoring. And, as we’ve emphasized in numerous columns, just using pulse oximetry and respiratory rate monitoring is not sufficient. Capnography has now become the gold standard for monitoring patients. A recent review (Geralemou 2016) highlights the evidence base that capnography predicts impending respiratory depression earlier than does either pulse oximetry or respiratory rate. That is especially true in patients who are receiving supplemental oxygen. And we’ve noted numerous times how in patients with OSA a nurse or respiratory therapist may respond to a pulse oximetry alarm only to find a patient now awake and breathing normally with a normal oxygen saturation. Then the patient goes back to sleep and develops airway obstruction.
Geralemou et al. note some of the concerns regarding this technology including consistent appropriate positioning of the end-tidal CO2 monitoring device in awake extubated patients, patient comfort, and less familiarity with this device compared to pulse oximetry by nursing staff.
But many hospitals have not yet adopted routine capnographic monitoring because of concerns over cost. Geralemou et al. point to a study which showed postoperative respiratory failure added approximately 9 hospital days to hospital length of stay, greater than $53,000 to hospital costs, and an almost 22% increase in mortality (Zhan 2003). The Canadian Agency for Drugs and Technologies in Health (CADTH) in 2016 did an analysis of end-tidal CO2 monitoring in the hospital setting (CADTH 2016). Though admitting that high level evidence of efficacy is limited, they performed an exploratory analysis which concluded that for patients in serious or critical condition and for patients with obstructive sleep apnea or receiving high doses of opioids in post-operative care, use of end-tidal CO2 monitoring is likely less costly and more effective than standard monitoring.
In addition, a business case has been made for the cost effectiveness of capnographic monitoring for procedural sedation for gastrointestinal endoscopy (Saunders 2016). Those authors found that the addition of capnography resulted in a 27.2 % and 18.0 % reduction in the proportion of patients experiencing an adverse event during deep and moderate procedural sedation/analgesia, respectively. The reduction in adverse events resulted in cost savings that accounted for the additional upfront purchase cost. Capnography was estimated to reduce the cost per procedure by $85 (deep) or $35 (moderate).
All these articles reinforce 2 best practices we feel need universal adoption:
Our prior columns on obstructive sleep apnea in the perioperative period:
June 10, 2008 “Monitoring the Postoperative COPD Patient”
August 18, 2009 “Obstructive Sleep Apnea in the Perioperative Period”
August 17, 2010 “Preoperative Consultation – Time to Change”
July 13, 2010 “Postoperative Opioid-Induced Respiratory Depression”
November 2010 “More on Preoperative Screening for Obstructive Sleep Apnea”
February 22, 2011 “Rethinking Alarms”
November 22, 2011 “Perioperative Management of Sleep Apnea Disappointing”
May 22, 2012 “Update on Preoperative Screening for Sleep Apnea”
February 12, 2013 “CDPH: Lessons Learned from PCA Incident”
February 19, 2013 “Practical Postoperative Pain Management”
March 26, 2013 “Failure to Recognize Sleep Apnea Before Surgery”
September 24, 2013 “Perioperative Use of CPAP in OSA”
May 13, 2014 “Perioperative Sleep Apnea: Human and Financial Impact”
March 3, 2015 “Factors Related to Postoperative Respiratory Depression”
August 18, 2015 “Missing Obstructive Sleep Apnea”
June 7, 2016 “CPAP for Hospitalized Patients at High Risk for OSA”
Chung F, Memtsoudis SG, Ramachandran SK, et al. Society of Anesthesia and Sleep Medicine Guidelines on Preoperative Screening and Assessment of Adult Patients with Obstructive Sleep Apnea. Anesthesia & Analgesia 2016; 123(2): 452-473, August 2016
Podcast: Article of the Month – August 2016 – Christine Park and Frances Chung
Interviewer: Christine Park
Interviewee: Frances Chung
Anesthesia & Analgesia August 2016, Volume 123, Issue 2;
Nagappa M, Chung F. Perioperative Complications & Stopbang Scores. A
Metaanalysis. 2016 annual meeting of the Canadian Anesthesiologists’ Society (abstract 152726) as discussed in: Vlessides M. STOP-Bang Questionnaire Ably Identifies Risks for Perioperative Complications. Anesthesiology News 2016; October 3, 2016
Sharma S, Chowdhury A, Tang L, et al. Hospitalized Patients at High Risk for Obstructive Sleep Apnea Have More Rapid Response System Events and Intervention Is Associated with Reduced Events. PLOS One 2016; Published: May 11, 2016
Geralemou S, Probst S, Gan TJ. The Role of Capnography to Prevent Postoperative Respiratory Adverse Events. NPSF Newsletter 2016; 31(2): 42-43 October 2016
Zhan C, Miller MR: Excess length of stay, charges, and mortality attributable to medical injuries during hospitalization. JAMA 2003; 290: 1868-1874
CADTH (Canadian Agency for Drugs and Technologies in Health). Capnography for Monitoring End-Tidal CO2 in Hospital and Pre-hospital Settings: A Health Technology Assessment. Ottawa: CADTH 2016 (CADTH health technology assessment; no.142); March 2016
Saunders R, Erslon M, Vargo J.Modeling the Costs and Benefits of Capnorgraphy Monitoring during Procedural Sedation for Gastrointestinal Endoscopy. Endosc Int Open 2016; 04(03): E340-E351
October 18, 2016
Yet More Questions on Contact Precautions
One of our recurrent themes has been unintended consequences of contact isolation precautions (see the list of our prior columns at the end of today’s column). Previous research has shown that patients in contact isolation have less contact by healthcare workers (and visitors) and this may lead to errors and omissions in care and other unintended consequences like decubiti, delirium, falls, and fluid/electrolyte disorders among other preventable adverse events.
In our May 2016 What's New in the Patient Safety World column “More Debate on Contact Precautions” we noted that Morgan and colleagues at the University of Maryland, who have done much of the work we’ve previously cited on adverse consequences of contact isolation, have reconsidered contact precautions for endemic VRE and MRSA (Morgan 2015). They did a literature review, a survey of the SHEA Research Network members on use of contact precautions, and a detailed examination of the experience of a convenience sample of hospitals not using contact precautions for MRSA or VRE. They found that there is no high quality data to support or reject use of contact precautions for endemic MRSA or VRE and that hospital practices are widely varied. They concluded that higher quality research on the benefits and harms of contact precautions in the control of endemic MRSA and VRE is needed and that until more definitive data are available, practices in acute care hospitals should be guided by local needs and resources.
But not all studies have found more adverse events in patients on contact isolation. Two publications (Croft 2015a, Croft 2015b) also came from the University of Maryland researchers and were part of a PhD dissertation (Croft 2015c). The first study (Croft 2015a) compared non-ICU hospital ward patients (medical and surgical) and found that preventable adverse events did not significantly differ between 148 patients on contact precautions on admission and 148 matched patients not on contact precautions. And hospital ward patients on contact precautions were less likely to experience noninfectious adverse events during their hospital stay than patients not on contact precautions. The second study (Croft 2015b) addressed patients in ICU’s and found that In ICUs where healthcare workers donned gloves and gowns for all patient contact, patients were no more likely to experience adverse events than in control ICUs. Thus, concerns of adverse events resulting from universal glove and gown use were not supported. The authors suggest that similar considerations may be appropriate regarding use of contact precautions.
Consider also that adherence to all elements of contact isolation precautions has always been less than optimal. One study which did 1300 observations at 11 teaching hospitals found that compliance with all 5 recommended components (hand hygiene before and after patient encounter, donning of gown and glove upon entering a patient room, and doffing upon exiting) was only 28.9% (Dhar 2014). They also found that as the proportion of patients in contact isolation increases, compliance with contact isolation precautions decreases. Placing 40% of patients under contact precautions represented a tipping point for noncompliance with contact isolation precautions measures
So what is the current status of contact isolation precautions in the US and what changes might we expect? Russell and colleagues, acknowledging that the risk:benefit ratio of contact precautions for methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococcus (VRE) remains controversial and that use of interventions such as daily bathing with chlorhexidine gluconate have become more widespread, did a cross-sectional survey of physicians in the Emerging Infections Network (Russell 2016). Over 90% of respondents routinely use contact precautions for MRSA and VRE, with the most widely used trigger being a positive culture for these pathogens. They found that 92% perform routine chlorhexidine gluconate bathing and 67% perform S. aureus decolonization with mupirocin for 1 or more subsets of inpatients. 23% reported using either hydrogen peroxide vapor or ultraviolet-C room disinfection at discharge. But practices for discontinuation of isolation varied widely. They also noted that free text responses frequently conveyed frustration and variation in the application, practice, and process for initiation and discontinuation of contact precautions. They conclude that the heterogeneity of practices and policies was striking and that evidence-based guidelines regarding contact precautions and other interventions are needed.
And now several studies have suggested that elimination of contact isolation precautions may not be detrimental. Edmond and colleagues (Edmond 2015) found that discontinuation of contact precautions for patients with MRSA and VRE colonization/infection had no impact on device-associated hospital-acquired infection rates in an academic medical center. And in a hematology-oncology unit with a high prevalence of VRE colonization the incidence of VRE bacteremia remained stable after discontinuation of VRE surveillance and contact precautions (Almyroudis 2016). Aggregated antibiotic utilization and nursing hours per patient days were similar between the 2 study periods.
It will, of course, be difficult to do a randomized controlled trial to determine whether contact precautions achieve beneficial outcomes that exceed any unintended negative consequences. But a new before/after study suggests that doing away with contact precautions may not be harmful. Martin and colleagues (Martin 2016) analyzed laboratory-identified clinical culture rates 1 year before and after routine contact precautions for endemic MRSA and VRE were discontinued and chlorhexidine bathing was expanded to all units at 2 California hospitals. Discontinuing routine contact precautions for endemic MRSA and VRE did not result in increased rates of MRSA or VRE after 1 year. Of course, this was not a randomized controlled trial. And the concurrent chlorhexidine intervention is a confounding factor. But the results are still strongly suggestive that routine contact precautions may not be necessary.
Moreover, the financial savings to the hospital from elimination of routine contact precautions in the Martin study were substantial. When combining isolation gown and chlorhexidine costs, the health system saved $643,776 in 1 year. Considering average room entries and donning time, estimated nursing time spent donning personal protective equipment for MRSA/VRE before the change was 45,277 hours/year (estimated cost, $4.6 million). They conclude that with cost savings on materials, decreased healthcare worker time, and no concomitant increase in possible infections, elimination of routine contact precautions may add substantial value to inpatient care delivery.
Another recent study demonstrated that flagging patients has having MRSA/VRE can lead to unwanted hospital operational consequences (Shenoy 2016). Shenoy and colleagues performed a retrospective cohort study at the Massachusetts General Hospital and found that MRSA/VRE designation was associated with delays in time to bed arrival, increased likelihood of acuity-unrelated within-hospital transfers and extended length of stay. They conclude that efforts to identify patients who have cleared MRSA/VRE colonization are critically important to mitigate inefficient use of resources and to improve inpatient flow.
So you should consider all the above in developing your policies on contact precautions. Decisions about who and when to use contact precautions should be made considering the potential benefits and potential harms, the clinical scenarios and epidemiology. Such decisions could be made on a case-by-case basis in most circumstances and you need to consider both healthcare workers and visitors (see our May 2016 What's New in the Patient Safety World column “More Debate on Contact Precautions” regarding visitors). You may want to audit your current compliance with contact precautions. If you do implement contact precautions, make sure that your care plans include appropriate interventions and monitoring to ensure that patients on contact precautions get all their medical and psychological needs met. And pay careful attention to developing criteria and mechanisms for discontinuation of such precautions.
Some of our prior columns on the unintended consequences of contact isolation:
Morgan DJ, Murthy R, Munoz-Price LS, et al. Reconsidering Contact Precautions for Endemic Methicillin-Resistant Staphylococcus aureus and Vancomycin-Resistant Enterococcus. Infect Control Hosp Epidemiol 2015; 36(10): 1163-1172
Croft LD, Liquori M, Ladd J, et al. The Effect of Contact Precautions on Frequency of Hospital Adverse Events. Infection Control & Hospital Epidemiology 2015; 36(11): 1268-1274, 2015 Nov
Croft LD, Harris AD, Pineles L, et al. The Effect of Universal Glove and Gown Use on
Adverse Events in Intensive Care Unit Patients. Clinical Infectious Diseases 2015; Advance Access published May 11, 2015
Croft L.The Effect of Contact Precautions on the Frequency of Hospital Adverse Events. Doctor of Philosophy Dissertation 2015; Universitiy of Maryland
Dhar S, Marchaim D, Tansek R, et al. Contact Precautions More Is Not Necessarily Better. Infection Control & Hospital Epidemiology 2014; 35(3): 213-219. Published online: 10 May 2016
Russell D, Beekmann SE, Polgreen PM, et al. Routine Use of Contact Precautions for Methicillin-Resistant Staphylococcus aureus and Vancomycin-Resistant Enterococcus: Which Way Is the Pendulum Swinging? Infection Control & Hospital Epidemiology 2016; 37(1): 36-40, 2016 Jan
Edmond MB, Masroor N, Stevens MP, et al. Infect Control Hosp The Impact of Discontinuing Contact Precautions for VRE and MRSA on Device-Associated Infections. Infect Control Hosp Epidemiol 2015; 36(8): 978-980
Almyroudis NG, Osawa R, Samonis G, et al.. Discontinuation of Systematic Surveillance and Contact Precautions for Vancomycin-Resistant Enterococcus (VRE) and Its Impact on the Incidence of VRE faecium Bacteremia in Patients with Hematologic Malignancies.
Infect Control Hosp Epidemiol 2016; 37(4): 398-403. Published online January 11, 2016
Martin EM, Russell D, Rubin Z, et al. Elimination of Routine Contact Precautions for Endemic Methicillin-Resistant Staphylococcus aureus and Vancomycin-Resistant Enterococcus: A Retrospective Quasi-Experimental Study. Infection Control & Hospital Epidemiology 2016; First View Published online: 26 July 2016, pp. 1-8
Shenoy ES, Lee H, Hou T, et al. The Impact of Methicillin-Resistant Staphylococcus aureus (MRSA) and Vancomycin-Resistant Enterococcus (VRE) Flags on Hospital Operations. Infection Control & Hospital Epidemiology 2016; 37(7): 782-790 Published online: 29 March 2016
October 25, 2016
Desmopressin Back in the Spotlight
It’s been almost a decade since our March 18, 2008 Patient Safety Tip of the Week “Is Desmopressin on Your List of Hi Alert Medications?” outlined our multiple concerns about the safety of desmopressin. Last week an FDA Advisory Panel recommended approval of a desmopressin nasal spray for treatment of nocturia (Bankhead 2016). The FDA has not yet ruled on approval but usually follows the recommendations of the advisory panels.
Several desmopressin formulations, including a nasal spray formulation, are already FDA-approved. But they are approved for conditions other than the treatment of nocturia. Approved indications are the treatment of central diabetes insipidus, primary nocturnal enuresis in children, and to maintain hemostasis in patients with von Willebrand’s Disease and Hemophilia A during surgery. There are no current FDA-approved drugs indicated for the treatment of nocturia.
But, in reality, we know that desmopressin is already being used off-label for the treatment of nocturia. A meta-analysis of use of desmopressin for nocturia in 2012 found five studies involving a total of 619 participants and 8 additional randomized controlled trials in a systematic review (Zong 2012). The authors concluded that “desmopressin might significantly decrease the frequency of nocturnal voids, nocturnal urine volume and nocturnal diuresis, potentially resulting in an extended duration of the first sleep period and improved sleep quality. The adverse effects of desmopressin were similar to those observed in the placebo group.” Based upon those studies, some clinicians have been using desmopressin for treatment of nocturia already.
But we are very concerned about the potential adverse consequences of its use for nocturia, particularly in view of the seeming limited clinical significance of its efficacy in clinical trials. Most of the safety concerns in our March 18, 2008 Patient Safety Tip of the Week “Is Desmopressin on Your List of Hi Alert Medications?” have not changed.
The applicant to the FDA is seeking a rather broad approval of the desmopressin nasal spray for “nocturia”. Remember: nocturia is a symptom of a variety of underlying conditions. Given the wide range of conditions giving rise to nocturia we can anticipate that some patients will be more prone than others to adverse consequences of this treatment.
The FDA briefing document (FDA 2016) presented to the FDA Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) summarized the clinical trials used to support the request for FDA approval. Patients recruited into the clinical trials were all age 50 or older and there were multiple exclusionary criteria. One wonders how many patients with those exclusionary conditions might ultimately be treated with the drug if it gets approved for broad use for nocturia.
First, the efficacy evidence. Enrolled patients had at least a six-month history of at least two nocturic episodes per night, on average. All received placebo during a 2-week lead-in period and then were randomized to receive either 0.75 mcg, 1.0 mcg, or 1.5 mcg of desmopressin nasal spray or placebo nightly (the second trial just randomized patients to 0.75 mcg or 1.5 mcg of desmopressin nasal spray or placebo nightly) for a 12-week treatment period. Co-primary efficacy endpoints were (1) change from baseline in the mean number of nocturic episodes per night and (2) percentage of patients with ≥50% reduction in mean number of nocturic voids per night. One of the two trials also included the Impact of Nighttime Urination (INTU) Questionnaire as a secondary endpoint. It appears that neither clinical trial included fluid intake restriction.
The FDA briefing document includes a discussion on the use of an ITT (intention-to-treat) analysis vs. a mITT (modified intention-to-treat) analysis but we won’t bore you with the details. Only the 1.5 mcg dose of desmopressin was statistically superior to placebo on both co-primary efficacy endpoints. Regarding the first endpoint, there was a mean reduction of 0.3-0.4 episodes per night (from a baseline of about three nightly nocturia episodes on average) with the 1.5 mcg dose compared to placebo. Though statistically significant, the FDA briefing document questions the clinical significance of this finding. In both trials, those that achieved at least 50% reduction in mean number of nocturic voids per night compared to placebo did so only with the 1.5 mcg dose (52% vs. 33% in one trial and 46% vs. 29% in the other). The 1.5 mcg desmopressin dose decreased the INTU Overall Impact score by 2.6 points more than placebo. That point difference was statistically significant but, again, of unclear clinical significance.
On the safety side, the incidence of subjects with at least one adverse event was slightly greater in those who received active drug compared to placebo. The common adverse events occurring at a greater incidence in those treated with active drug were nasopharyngitis, urinary tract infection, hypertension/blood pressure increased, sneezing, nasal congestion, back pain, dizziness, and hyponatremia. But the incidence of serious adverse events was similar to the incidence in the placebo group. All 5 deaths occurred in those receiving active drug but it was felt that the drug did not likely contribute in at least 3 of those and was questionable in the others. Four of the 5 deaths occurred in patients age 75 and older. The incidence of subjects discontinuing due to an adverse event was slightly greater in active drug group than the placebo group. The most common adverse events leading to discontinuation in those on active drug were nasal discomfort and hyponatremia. Hyponatremia occurred with incidences of 1.1%, 0%, and 0.2% respective in the 1.5 μg, 0.75 μg, and placebo treatment groups. The incidence of hyponatremia with active drug appears lower among subjects younger than 65 years of age compared to those over 65 years of age.
Prior studies have looked at adverse events in patients receiving intransal desmopressin. In a report on adverse events during the use of intranasal desmopressin acetate for patients with haemophilia A or von Willebrand disease, Dunn and colleagues noted 27/40 patients experienced some clinical signs of symptoms related to the drug (Dunn 2000). Most were mild but several reported moderate-to-severe side effects, including one patient who required medical intervention for symptomatic hyponatremia. The authors suggest that side-effects may be minimized if patients adhere to instructions regarding fluid intake and composition while using intranasal desmopressin. Lose and colleagues looked at the effects of long-term (10-12 months) desmopressin use for nocturia (Lose 2004). Desmopressin was well tolerated with few males (14%) or females (10%) withdrawing due to adverse events. Most adverse events were mild (44%) or moderate (44%) in severity. Four males experienced serious drug related adverse events, (dizziness, cardiac failure, headache and vomiting, chest pain and hypertension) and one female experienced 4 serious drug related adverse events (hyponatremia, headache, nausea and vertigo). Two patients had clinically significant hyponatremia.
On the basis of the clinical trial data, you’d probably conclude that this is a drug that has a marginal clinical value (though it may be more valuable to some patients) but appears to be relatively safe. The FDA Bone, Reproductive and Urologic Drugs Advisory voted 14-4 margin that benefits of the treatment outweighed potential risks.
But we have 2 major concerns. First is that the drug would undoubtedly get used in patient populations other than those enrolled in the clinical trials. Second is that the drug is likely to be prescribed by or managed by healthcare personnel who are relatively unfamiliar with it.
The exclusion criteria in the clinical trials were diabetes insipidus, uncontrolled diabetes mellitus, congestive heart failure (New York Heart Association Class IIIV), polydipsia, uncontrolled hypertension, nephrotic syndrome, peripheral edema (>2+ pretibial edema on physical exam), history of urinary retention, neurogenic detrusor overactivity, obstructive sleep apnea, loop diuretics, glucocorticoids, and severe lower urinary tract symptoms due to benign prostatic hypertrophy, overactive bladder, or severe stress urinary incontinence. Yet the application is for approval of the desmopressin formulation for any adult with nocturia. Undoubtedly it would get used in some patient populations in whom it has not been studied.
Hyponatremia is probably the most feared potential complication of desmopressin therapy. Keep in mind that in the clinical trials, fasted serum sodium concentration was assessed on Days 1 (baseline), 15, 29, 43, 57, 71, 85, and 99 of the studies. In the real world it is not likely that there will be such frequent monitoring of serum sodium levels. And it is particularly when intercurrent events occur (such as infections) that further perturbations of serum sodium might occur in patients on desmopressin therapy.
Perhaps our most serious concern involves the patient receiving desmopressin therapy who now gets hospitalized for either an intercurrent condition or an elective procedure. The healthcare personnel dealing with such patients on an inpatient basis are quite likely to have limited experience with and knowledge about the use of desmopressin.
We did our March 18, 2008 Patient Safety Tip of the Week “Is Desmopressin on Your List of Hi Alert Medications?” because of several reports of adverse events related to desmopressin over a short period of time. The FDA issued an alert in December 2007 (FDA 2007) about the dangers of severe hyponatremia and seizures related to desmopressin. This alert was based on their review of 61 post-marketing cases of hyponatremic seizures associated with desmopressin use, including two fatal cases. Children with primary nocturnal eneuresis (PNE) taking intranasal formulations of desmopressin are particularly susceptible to these complications so the FDA alert cautioned that the intranasal formulation was no longer indicated for treatment of PNE. It also cautioned that treatment of PNE with desmopressin tablets should be interrupted during acute illnesses that may lead to fluid/electrolyte disturbances. And it cautioned that all desmopressin formulations should be used with caution in patients at risk for water intoxication with hyponatremia or in patients taking medications that may cause them to drink more fluids, such as tricyclic antidepressants or SSRI’s. The FDA has subsequently archived that safety alert. Labelling changes were made in 2007 and a safety review in 2010 revealed no further deaths or serious adverse events.
ISMP Canada issued an alert (ISMP Canada 2008) shortly thereafter about the need for monitoring protocols in patients taking desmopressin. This followed a report of a patient who developed diabetes insipidus following neurosurgical removal of a nonmalignant brain tumor. The patient was treated with desmopressin and had numerous problems with fluid/electrolyte management and had a positive fluid balance of several liters, resulting in death presumably from water intoxication and cerebral edema. Even minor increases in electrolyte-free water have been associated with disproportionately high increases in intracranial pressure. Contributing factors in this case were continued administration of hypotonic fluids and desmopressin after the serum sodium had normalized and the rapidity of the shift from a hypernatremic state to a hyponatremic state.
And a case study in an AHRQ WebM&M (AHRQ 2008) dealt with an adverse outcome related to desmopressin. Though the WebM&M focused on the issue of “hold” orders, the case again pointed out the dangers associated with desmopressin.
Those cases point out two important reasons to identify desmopressin as a hi-alert medication. First, it is a drug that may be associated with serious, even fatal, complications. Second, it’s a drug that many physicians, nurses, and pharmacists have limited experience with. Many patients now end up being admitted for an unrelated reason and staff unfamiliar with desmopressin are saddled with managing it during a hospitalization. That is exactly the circumstance where having available strict protocols and monitoring programs is a smart addition to your medication safety program.
The ISMP Canada alert recommends development and use of standardized order sets (preprinted orders or electronic order sets), including monitoring parameters, for postoperative management of postoperative neurosurgical patients to facilitate early diagnosis and management of central diabetes insipidus. They also discuss the need for discussion of such potential complications to be a part of all hand-offs. They stress the importance of standardized order sets for monitoring patients treated with desmopressin, including the frequency with which the parameters should be monitored. Urine output, by itself, should not be used to determine whether subsequent doses of desmopressin are given. The trend in the monitored parameters may be as important as the actual numbers. The choice and rate of IV fluids and the need for desmopressin should be determined by the results of those parameters. The patients should be carefully monitored for signs or symptoms of hyponatremia or water intoxication. Besides seizures, headache, nausea, vomiting and obtundation are common symptoms of water intoxication. In addition to the standardized order sets, everyone caring for the patient should have ready access to information and protocols about the drug and the monitoring. Families, too, should be engaged in monitoring because they may pick up subtle changes in the patient before professional staff would. And it is critical that the laboratory test results be available on a prompt basis.
Though the ISMP Canada alert was aimed at neurosurgical patients, the advice is wise and most of it is also applicable to other types of patients being treated with desmopressin. Perhaps the most important initial question to ask is whether continued use of desmopressin is even indicated during the acute hospitalization. For many of it uses, particularly the bladder-related ones, there may be no reason to use desmopressin at all during the hospital stay. If it is determined that desmopressin should be continued, then the type of standardized order sets and monitoring protocols similar to those in the ISMP Canada alert should be used.
Most hospitals have included in their hi-alert medication safety programs categories of more frequently used drugs that have a narrow therapeutic index or possible severe adverse side effects and then looked at drugs within those categories that may be particularly likely to be unfamiliar to clinical staff. For example, most hospitals include anticoagulants in their hi-alert medication safety program and typically focus on coumadin, heparin, LMWH’s, and antiplatelet agents. However, some have recognized that drugs like argotroban may need to be used under rare circumstances and that few practitioners have extensive experience with that drug. Therefore, they have made special attempts to make appropriate information on the less familiar drug available to practitioners and have developed standardized order sets for dealing with such drugs. The same sort of logic should apply to desmopressin and it should be addressed in your hi-alert medication safety program.
One additional concern is the potential risk that an order for desmopressin might erroneously be interpreted as an intravenous medication rather than intranasal one, potentially leading to very serious complications. One such incident where it was mistakenly given intravenously was reported by ISMP (ISMP 2009). The example given included the use of the abbreviation “IN” (for intranasally), an abbreviation that ISMP would put on a “do not use” list. ISMP notes that, in addition to being mistaken for “IV”, the abbreviation “IN” can also be mistaken for “IM”. ISMP suggests writing out “intranasal” or “nasally” or using “NAS” instead.
We would hope that the FDA ultimately limits the scope of the population for which intranasal desmopressin is approved. Some have stated that “nocturnal polyuria”, implying the need to urinate multiple times at night, may be a more appropriate indication for use of intranasal desmopressin. But in anticipation that it will approve its use for nocturia in some capacity and knowing that some clinicians have already been using it for that purpose, we think that all hospitals should be doing certain things:
And for the clinician, use of desmopressin for nocturia should only be considered when other non-pharmacologic measures have been taken and when the nocturia truly impairs quality of life. Nocturia may contribute to cumulative sleep deprivation and may also increase the risk of falls in the elderly (see our June 9, 2015 Patient Safety Tip of the Week “Add This to Your Fall Risk Assessment” and our many columns on fall risk and prevention). First and foremost, remember that nocturia is a symptom and has a variety of causes. Treating the underlying cause is most important. For example, nocturia may be a manifestation of congestive heart failure. So treatment of the CHF should be primary. In a review of management of nocturia in the elderly, Osman and Chapple note that lifestyle interventions, though not widely studied on a population basis, are often used based upon both logical and anecdotal evidence (Osman 2013). Lifestyle measures included reducing caffeine and alcohol, limiting evening fluid intake, leg elevation and interventions aimed at improving sleep (e.g., exercise, and warm temperature). And when desmopressin might be considered, good communications are required, not only between physician and patient but also between physicians. Most likely it may be a urologist who recommends desmopressin but the primary care physician is usually in a better position to understand potential interactions with other medications and comorbidities. The young and the elderly are two populations that are more prone to develop hyponatremia during desmopressin treatment. Desmopressin also has a relatively long and variable duration of action. Issues of unusually long half-life or bioactivity have been implicated in some cases of adverse events related to desmopressin (Dehoorne 2006). In some cases, hyponatremia due to desmopressin may have been made more likely by a second drug, such as ibuprofen (Garcia 2003).
Desmopressin is a valuable drug for many conditions. Though it may be effective and relatively safe for treating nocturia in a relatively narrow population, expansion of its use to other patient populations may well result in unintended consequences.
Bankhead C. FDA Panel Backs Nasal Spray for Nocturnal Polyuria - Support for intransal desmopressin despite reservations. MedPage Today October 19, 2016
Zong H, Yang C, Peng X, Zhang Y. Efficacy and safety of desmopressin for treatment of nocturia: a systematic review and meta-analysis of double-blinded trials. International Urology and Nephrology 2012; 44(2): 377-384
FDA (US Food and Drug Administration). FDA Briefing Document. Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC). October 19, 2016
Dunn AL, et al. Adverse events during use of intranasal desmopressin acetate for haemophilia A and von Willebrand disease: a case report and review of 40 patients. Hemophila 2000; 6(1): 11-14 January 2000
Lose G, Mattiason A, Walter S, et al. Clinical Experiences with Desmopressin for Long-Term Treatment of Nocturia. The Journal of Urology 2004; 172(3): 1021-1025
FDA (US Food and Drug Administration). Information for Healthcare Professionals: Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray). FDA Safety Alert 12/4/2007. Now archived and unavailable. http://www.fda.gov/cder/drug/InfoSheets/HCP/desmopressinHCP.htm
ISMP Canada Alert March 3, 2008. Desmopressin Incidents Identify a Need to Evaluate Monitoring Protocols. http://www.ismp-canada.org/download/ISMPCSB2008-01DDAVP.pdf
AHRQ WebM&M. Hold That Order. March 2008 http://www.webmm.ahrq.gov/case.aspx?caseID=171
ISMP (Institute for Safe Medication Practices). On the “do not use” list. ISMP Medication Safety Alert! Nurse Advise –ERR Edition 2009; 7(1): 3 January 2009
Osman NI, Chapple CR. Focus on Nocturia in the Elderly. Aging Health 2013; 9(4): 389-402
Dehoorne JL, Raes AM, van Laecke, E, Hoebeke EP, Vande Walle JG. Desmopressin Toxicity Due to Prolonged Half-Life in 18 Patients With Nocturnal Enuresis.
The Journal of Urology, 2006; 176: 754-758 http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B7XMT-4K8Y775-3J&_user=10&_coverDate=08%2F31%2F2006&_alid=707110399&_rdoc=17&_fmt=summary&_orig=search&_cdi=29679&_sort=d&_docanchor=&view=c&_ct=73&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=50356436a760b8c893564231548ead5e
García EBG, Ruitenberg A, Madretsma GS, Hintzen RQ. Hyponatraemic coma induced by desmopressin and ibuprofen in a woman with von Willebrand's disease. Haemophilia 2003; 9: 232-234 http://www.blackwell-synergy.com/doi/abs/10.1046/j.1365-2516.2003.00719.x?prevSearch=allfield%3A%28garcia%29
November 1, 2016
CMS Emergency Preparedness Rule
Most of us who have long worked in hospitals are aware of many contingencies in place for certain emergencies. For instance, we know that there are backup electrical generators for power outages and that there are periodic drills to test that the backup generator is working correctly. But not all healthcare venues have such systems. Several years ago we participated in a discussion about what happens in dialysis facilities when there is a power outage. It turns out that in many states there is no requirement that dialysis facilities even have backup power sources. So it becomes even more important that all such facilities have comprehensive plans for what to do in such emergencies. Moreover, hospitals are also vulnerable to emergencies other than just power outages, as experiences with some of the recent hurricanes and other natural disasters have demonstrated.
CMS (Centers for Medicare & Medicaid Services) has now put forward an Emergency Preparedness Regulation (CMS 2016a). This regulation goes into effect on November 16, 2016 and all affected facilities and providers must comply and implement all requirements one year after the effective date, on November 16, 2017. The final rule “Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers” was posted in the Federal Register on September 16, 2016 (CMS 2016b). But the latter is almost 200 pages and difficult to read so we think you’ll get the most use from the CMS 2016a website and its links.
The new rule applies to all 17 CMS provider and supplier types, though the exact requirements vary by provider/supplier type as outlined in tabular form on the CMS website. And ASPR TRACIE (Office of the Assistant Secretary for Preparedness & Response. Technical Resources Assistance Center Information Exchange) provides resources and samples to help facilities comply with the new rule (ASPR TRACIE 2016). There are 4 basic elements for each provider type to consider:
Emergency plans must take into account not only the facility level but also the community and regional or even statewide level. They need to include a risk assessment and consideration of hazards likely to occur in the geographic area, care-related emergencies, equipment and power failures, interruption in communications (including cyberattacks), and full or partial loss of the facility or supplies. The emergency plan is to be reviewed and updated at least annually.
While there should be an all-hazard plan (fires, bioterrorism, tornadoes, floods, pandemics, etc.), the facility/organization needs to also consider contingencies for emergencies more likely in their geographic area (eg. are they vulnerable to earthquakes? hurricanes? etc.) Consider also that indirect hazards affecting the community but not the facility directly may still interrupt services, supplies or staffing. The specific vulnerabilities of the facility for each identified hazard should be analyzed to determine the actions to be taken. Key staff responsible for executing the plan must be identified, as well as overall staffing requirements and defined staff responsibilities. That would include designating critical staff, providing for other staff and volunteer coverage. You also need to consider staff needs, including transportation and sheltering critical staff members’ family. The plan should include identification and maintenance of sufficient supplies and equipment to sustain operations and deliver care and services for 3-10 days, based on each facility’s assessment of their hazard vulnerabilities. Consider how you will communicate with staff, families, patients, and the outside world not only during, but also before and after, the emergency. And you need to have arrangements with your suppliers and vendors to ensure you can increase supplies or provisions in the event you have a surge in capacity as the result of an emergency event.
Your emergency plan, policies and procedures should attempt to include criteria for declaration of the various types of emergency and also for declaration that the emergency condition is over.
The emergency plan should also contain a “shelter in place” plan (for example, for a storm, active shooter incidents, etc.) and an evacuation plan. We recommend that you have two locations designated as “command centers” or “control centers”. Most hospitals use a designated conference room or board room for their internal command center. However, for emergencies necessitating evacuation of the facility you should have an external command center (eg. nearby building) designated. Both sites should have methods of communicating by multiple means (land phone lines, cell phones, walkie-talkies, keeping in mind they must be kept fully charged at all times), backup power supplies, lists of phone numbers for all key internal and external personnel/agencies, and maps of the facilities and grounds.
The ASPR TRACIE (Office of the Assistant Secretary for Preparedness & Response. Technical Resources Assistance Center Information Exchange) website has sample emergency plans and templates among its many valuable resources (ASPR TRACIE 2016). The ASPR TRACIE resources are terrific and cover the needs for a variety of facility types. For example, it provides links to over 50 articles, plan templates and other resources for dialysis centers with multiple lessons learned from mass power outages, hurricanes, earthquakes, tsunamis, floods, and water contamination alerts.
You’ll find particularly useful the Emergency Preparedness Checklist downloadable from the CMS Emergency Preparedness Rule website. This allows you to track where you stand on all the tasks necessary to meet the requirements of the new rule.
CMS is looking for the following elements in an Evacuation Plan:
When you must perform a facility evacuation for something like a fire, you need to include in your plan the sites where you will congregate and do a patient and staff count. In the event of an evacuation, you also need to determine how residents will be identified and ensure the appropriate identifying information will be transferred with each resident (eg. name, date of birth, social security number, photograph, etc). But you also should make sure that information regarding diagnosis, current medications, diet are provided as well as information about health insurance, family/caregiver contact, advance directives, etc. Your plan should include how this information will be secured and transported (e.g., laminated documents, water proof pouch around resident’s neck, water proof wrist tag, etc.).
And part of your evacuation plan should be a Facility Reentry Plan. That should detail who will authorize reentry to the facility after an evacuation, the procedures for inspecting the facility, how it will be determined when it is safe to return to the facility after an evacuation, and how patients will travel back to the facility.
Facility transfer agreements are typically done among regional facilities. The CMS site has a link to a Facility Transfer Agreement Example. But your emergency plan should include not only what to do if there is an emergency in your facility or region but also contingencies for remote disasters. For example, hospitals as far away as western New York needed to have plans to handle excess capacity if patients in the New York City area or New Jersey were forced to evacuate during Hurricane Sandy. Border towns and cities may also need to include cooperation with facilities across the border in, for example, a neighboring Canadian province.
The CMS Emergency Preparedness Checklist also has a nice section on suggested principles of care for relocated patients/residents, including addressing their fears, anxieties, and psychological needs. It also reminds you to make sure that any vendors or volunteers who will help transport residents and those who receive them at shelters and other facilities are trained on the needs of the chronic, cognitively impaired and frail population and are knowledgeable on the methods to help minimize transfer trauma.
The Communication Plan must include a system to contact staff, including patients’ physicians, other necessary persons, and also comply with Federal and State Laws. It should be well-coordinated within the facility, across health care providers, and with state and local public health departments and emergency management agencies. Your communication plan should also include phone numbers for families to call.
Communication with community facilities and resources is not a one-time event. Hospitals typically hold drills with other community resources at least annually in the form of a “disaster drill”. Those are usually coordinated by some form of regional planning and emergency response agency. But we also encourage hospitals and other healthcare facilities to meet with and drill with their local fire department (see our October 21, 2014 Patient Safety Tip of the Week “The Fire Department and Your Hospital”) and police department (for active shooter drills, absconds, kidnappings, etc.). There are certain aspects of facilities that those first responders must be familiar with, such as the dangers inherent in MRI suites.
While it may not be formally required by CMS, one of the emergencies you must be prepared for is that of a missing patient. We refer you to our April 7, 2015 Patient Safety Tip of the Week “Missing Patients and Death” for details on what you need to do in the case of a missing patient, including how to announce the problem, set up a command center, perform grid search, alert appropriate authorities (and family), and what to do when you find the patient.
The other emergency you need a plan for is infant abduction. We refer you to our Patient Safety Tips of the Week for December 20, 2011 “Infant Abduction” and September 4, 2012 “More Infant Abductions” for details.
Critical to emergency preparedness is training and drills. Everyone who works in your facility needs to be knowledgeable about your emergency preparedness plan(s). While most often staff are educated about the plan(s) during initial orientation, you must re-educate them at least annually and reinforce it with periodic drills. Unfortunately, the staff that tend to slip through the cracks are those temporary hires or per diem floating staff that are only at your facility for short periods. The same applies to housestaff that may rotate through your facility for only short periods.
The only way to be truly prepared for emergencies is to practice ahead of time. This is done through drills. Our readers have heard us harp on the need for drills for surgical fires, elopements, absconds, missing patients, infant abductions, fires and others. So here we just want to remind you of two things about drills. First is that we are often disappointed with the lack of detail and formal assessment about the drills. You should always have designated observers who are recording important aspects of the drill and then have a formal evaluation with appropriate constituents. Second is a reminder that certain emergencies might be piggybacked (eg. an elopement or an infant abduction occurring when a fire alarm is triggered). So we recommend that periodically you include both types of drill at the same time (eg. initiate an infant abduction drill during a fire drill).
CMS also stresses that your training also needs to address psychological and emotional aspects on caregivers, families, residents, and the community at large. And your plan needs to consider more mundane issues like mechanisms for patients to make claims for personal effects lost during the emergency.
Just as you need to conduct a review of all your emergency drills, you need to at least annually review your Emergency Preparedness Plan(s). Such review should include lessons learned from your drill reviews, any actual emergencies, newly identified threats or hazards, and any new regulations or infrastructure changes.
Lastly, let’s get real – no one could possible remember all the things they need to do for each type of emergency. Even as a hospital medical director, I had to keep with me checklists of what my responsibilities were for each type of emergency. There are a couple ways to do it. You can’t fit much more than the “RACE” acronym for fires on the back of your facility ID badge. Lots of facilities have notebooks or packets of letter-sized paper with instructions. No one will carry those around! So there are other options. One is to have thin packets of small laminated cards with instructions for each emergency/drill so that each individual could have a tailored set that could fit on a key ring and fit in one’s pocket. That also provides an easy way to help those temporary individuals who will only be at your facility for short periods. The other method, given that almost everyone nowadays has a smartphone, is to provide the role-specific instructions for them on their smartphone. Those could be easily found by a PDF reader on the smartphone. But we find that putting them in the notes section of most smartphone contact lists is the best way to make them more easily accessible. For example, under the “last name” or “company” field in your contact list enter “missing patient” and then under the “notes” field enter all the steps you must follow. You can even use the phone number fields for any key phone numbers someone might need to call (eg. one for your command center, another for the police department, etc.). You can even customize your headings for when you have different roles. For example, you could have them under multiple listings such as “Fire – charge nurse” or “Fire – staff nurse” or “Fire – nurse supervisor” for when you have roles that might change. Lastly, so you don’t have to use the search function in your contact list, either put the entries in your “favorites” list of phone numbers or precede each with whatever letter/number/symbol that your particular smartphone sorts to the top of your contact list.
Hopefully, your facility is already in compliance with most of these requirements but the new CMS Emergency Preparedness Rule provides additional incentive to take a look at the gamut of your emergency preparedness activities and update them to ensure you meet all the CMS requirements.
CMS (Centers for Medicare & Medicaid Services). Emergency Preparedness Rule. 2016
CMS (Centers for Medicare & Medicaid Services). Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers. Federal Register 2016; 81(180): 63860-64044 September 16, 2016
DHHS (US Department of Health and Human Services). Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers. ASPR TRACIE (Office of the Assistant Secretary for Preparedness & Response. Technical Resources Assistance Center Information Exchange). Last updated October 25, 2016
CMS (Centers for Medicare & Medicaid Services). Facility Transfer Agreement Example.
CMS (Centers for Medicare & Medicaid Services). Emergency Preparedness Checklist for All Providers.
Print “CMS Emergency Preparedness Rule”
November 8, 2016
Managing Distractions and Interruptions
We’ve done lots of columns on the negative impact of distractions and interruptions on patient safety. Our most recent column on distractions and interruptions (see our August 30, 2016 Patient Safety Tip of the Week “Can You Really Limit Interruptions?”) summarized some of the evidence-based interventions used to minimize the negative impact of interruptions and distractions.
But not all interruptions are detrimental. In fact, many interruptions alert healthcare personnel to urgent patient care needs and have a positive impact on patient safety. The key, therefore, is determining which interruptions are potentially beneficial and avoiding the ones that are likely detrimental.
A new study, using a mixed methods approach, sought to help differentiate the “good” interruptions from the “bad” ones (Myers 2016). They found that, on average, nurses were interrupted every 11 min, with 20.3% of their workload triggered by interruptions. Those figures are comparable to most other studies on nursing interruptions. They then developed a statistical model which showed that alarms and call lights returning nurses’ attention to the patient outside the patient room are beneficial, while interruptions in the patient room are generally detrimental. Beneficial interruptions are those that return the nurse’s focus to the patient and those supporting patient-clinician and clinician-clinician communications.
Another timely paper has good suggestions regarding ways to minimize detrimental interruptions (Bravo 2016). The authors combined data from 2 of their previous studies comparing medication passes without recorded interruptions or distractions to those which had interruptions and/or distractions. Of those patients, the average number of interruptions/distractions was 1.4 per patient. The interruptions were dichotomized into “routine” or “urgent”. The “urgent” interruptions comprised 8.3% of the total number of interruptions.
In the studies by Bravo et al. the most frequent sites of interruptions were the bedside (46%) and medication room (27%). At the bedside, the types of interruptions were need for patient and/or family education, patient request for toileting assistance, and coordination of patient schedules with other members of the health care team. Problematic in the medication room was miscellaneous banter by other nurses unrelated to medication administration protocols. The third most common site for interruptions was the hospital unit (13.5%) and an example given was a nurse moving toward a patient room to administer medications being interrupted by another healthcare provider to give additional patient orders or to clarify patient status. Initiators of the interruptions were other nurses (43%), other members of the healthcare team (25%), patients (18%), and family/visitors (7.6%).
The Bravo article focuses on two key strategies to minimize the risk of distractions and interruptions:
The programmed script, as exemplified in a study from Duke (Williams 2014), should include a statement about the need to avoid unnecessary interruptions during medication administration as a patient safety feature and should also include clear language to assure patients/families that their needs and concerns are still important.
The “3 D’s” are “DEFLECT”, “DEFER”, and “DETERMINE”. Deflection is modifying or managing the need so it is no longer an issue for the patient/family. Deferring is briefly postponing something that will be handled later by the nurse (and communicating this to the patient). Determining is seeing if someone else can safely assist with the patient need.
A third key strategy is coordinating other patient care with the medication administration process. For example, one of the commonest interruptions is patient requests for assistance in toileting. So a strategy might be to ask a care assistant to attend to the patient’s toileting needs. We’ve also noted how hourly rounding programs can help attend to such needs so a nurse would not be interrupted during medication rounds.
Bravo et al. also recommend asking patients about their preferred liquid for taking oral medications. In our August 30, 2016 Patient Safety Tip of the Week “Can You Really Limit Interruptions?” we noted nurses having to stop and get water or a cup for the patient as a frequent source of interruptions. So knowing ahead of time how to facilitate a patient taking an oral medication and having the appropriate supply available can help minimize such a distraction or interruption.
Interestingly, the Bravo article does not focus on reduction in phone calls, an intervention important in the study by Flynn et al (Flynn 2016) noted in our August 30, 2016 Patient Safety Tip of the Week “Can You Really Limit Interruptions?” and in the Duke study (Williams 2014).
We again refer you back to the article by Flynn et al (Flynn 2016) that did an excellent job of summarizing the literature on interruptions and their impact on medication administration and chronicling those interventions which are evidence-based:
The Flynn article nicely outlines in tabular form with annotations the numerous studies in the literature on the impact of interruptions.
And we’d like to remind all again about an important point that dovetails with the discussion of beneficial vs. detrimental interruptions. Most studies on interruptions during the medication administration process use only the medication error rate as the patient outcome parameter measured. The total adverse event rate should also be reported in such studies to ensure that the interventions do not have unintended consequences on aspects of care other than medication safety.
Prior Patient Safety Tips of the Week dealing with interruptions and distractions:
Myers RA, McCarthy MC, Whitlatch A, Parikh PJ. Differentiating between detrimental and beneficial interruptions: a mixed-methods study. BMJ Qual Saf 2016; 25: 881-888 Published Online First: 16 November 2015
Bravo K, Cochran G, Barrett R. Nursing Strategies to Increase Medication Safety in Inpatient Settings. Journal of Nursing Care Quality 2016; 31(4): 335-341
Williams T, King MW, Thompson JA, Champagne MT. Implementing evidence-based medication safety interventions on a progressive care unit. Am J Nurs 2014; 114(11): 53-62
Flynn F, Evanish JQ, Fernald JM, et al. Progressive Care Nurses Improving Patient Safety by Limiting Interruptions During Medication Administration. Crit Care Nurse 2016; 36: 19-35
November 15, 2016
Surgical Specimen Mishaps
Mishaps involving surgical specimens can have devastating impacts on patients. Lost specimens, mislabeled or misidentified specimens, inadequate specimens, and others can lead to misdiagnoses, delays in diagnosis or treatment, incorrect treatments, and repeat surgical procedures for patients. Our multiple prior columns on these issues have highlighted that the majority of such errors occur in the pre-analytic phase of the laboratory spectrum but errors can occur in virtually any phase.
Now, one of the most comprehensive analyses on surgical specimen mishaps has been published from a patient safety organization (Steelman 2016) and there are lessons here for everyone. Steelman and colleagues analyzed 648 adverse events and near misses related to surgical specimens reported (voluntarily) over a 3 year period by members of the PSO consortium of mostly academic hospitals and affiliates.
As expected, the pre-laboratory phase accounted for the vast majority of issues (93%). Problems with specimen labeling (49%), specimen transport or storage (38%), and specimen collection (24%) were most common. Occasionally (6%) issues with orders or order entry were problematic. But nearly a quarter of the issues related to specimen collection. Problems were cited with the incorrect specimen collection solution, lack of any solution or preservative, wrong container, or collection technique.
About a third of the specimen collection issues involved specimens not immediately being placed into specimen containers. That resulted in some specimens being temporarily or permanently lost. They might be left in the surgical field or accidentally discarded. Sometimes the sample size was too small and sometimes a specimen might be placed in the wrong type of container. Some of the contributing factors identified include inadequate staff knowledge or training, failed communication or handoffs, and environmental issues (eg. poor lighting). Inattention, distractions and interruptions are common contributing factors to all types of error.
Almost half of all events involved specimen labeling. These involved missing labels, missing requisitions, or labels and requisitions that were incomplete, illegible or inaccurate. Often missing were items such as date and time of collection, site or side of the specimen, clinical information, diagnosis, or mismatches related to patient identifiers used, etc.
Specimen transport is another phase prone to error. Sometimes the specimens are not immediately transported to the lab or were stored incorrectly while awaiting transport. Examples would be when specimens are set aside temporarily or put in a refrigerator or collection box. Batching may lead to delays. And sometimes specimens may be taken to the wrong area of left in an unattended place. Breakage or leakage may also occur during transport.
Only 10% of the issues related to the laboratory phase. These included delays in processing or analyzing specimens, loss or misplacement of specimens within the lab, wrong tests performed, or incorrect labeling during analysis.
Only 3% of the issues in the analysis involved the post-laboratory phase. We suspect these were likely underreported since personnel involved in analysis of “lab” events may never be made aware of issues like clinician failure to follow up on reports on a timely basis, etc.
The contributing factors identified are common to those we see in a host of medical errors. These include distractions and interruptions, inattention, inadequate training or knowledge, miscommunication, handoff failures, mistaken assumptions, workload issues, etc. Certain times (“late” hours or “after” hours) may be particularly vulnerable.
Fortunately, patient harm was apparently relatively rare in this study, perhaps because many of the reports in this analysis were from near-misses. The errors were often picked up before reaching the patient. But in 7% there was need for additional treatment and 1% temporary or permanent patient harm.
The authors provide a nice discussion of potential interventions you should be considering to avoid such errors. For example, having access at the point of care to any information, policies or procedures regarding specimen collection and solutions/fixatives is important. Use of technology-based solutions for patient and specimen identification (barcoding, RFID, etc.) should be considered.
One important intervention is one we’ve often mentioned: inclusion in your pre-surgical briefing or huddle a discussion of what surgical specimen(s) you anticipate (we advocate you use a checklist for your pre-op briefing that includes such an item). And don’t forget to include it in your post-op debriefing. Often in that debriefing it becomes obvious that no specimen was collected and sent to the lab so an immediate search may be able to locate the missing specimen at a time when it may be still suitable for analysis (the trashcan is a common location). However, we would also point out you should never assume that specimens found after being temporarily lost belong to the current patient (you can consider some of the DNA identification techniques discussed in our prior columns). Those DNA identification techniques are also valuable in cases of suspected specimen mislabeling.
The authors recommend you conduct a proactive assessment of you potential vulnerabilities. You could do that as a FMEA (failure mode and effects analysis) or the sort of “tracer” analysis that we described in our March 6, 2012 “’Lab’ Error”.
The study did not have data available on the cost of errors encountered. From reports most felt the costs incurred were relatively low. But further lab testing or monitoring were needed in 13% and 5% of patients, respectively, and 3% required extended length of stay or admission or a higher level of care. Only 1% apparently required additional surgery. Our only comment is that you likely underestimate the costs incurred unless you formally analyze them. Our September 27, 2016 Patient Safety Tip of the Week “Lab Errors Costly” noted substantial costs associated with other types of lab error. Plus, you’ll also usually find that tying a cost to system vulnerabilities is a good way to get your CEO and CFO to provide the resources you need to address those vulnerabilities.
All it takes is one case of a patient receiving an incorrect diagnosis or needing an unnecessary surgical procedure to risk your whole organization’s reputation. You owe it to your patients and your staff and your community to ensure that your entire process for managing surgical specimens is as fault-free as possible.
Some of our other columns on errors related to laboratory studies:
Steelman VM, Williams TL, Szekendi MK, et al. Surgical Specimen Management: A Descriptive Study of 648 Adverse Events and Near Misses. Arch Pathol Lab Med 2016; published online September 9, 2016
Print “Surgical Specimen Mishaps”
November 22, 2016
Leapfrog, Picklists, and Healthcare IT Vulnerabilities
In the past few months there have been multiple studies demonstrating that we still have a long way to go in bridging the human-computer interface, at least as far as electronic medical records go. The full potential of electronic health records and clinical decision support tools has yet to be realized.
First was a study of children’s hospitals using the pediatric version of the Leapfrog Group’s CPOE evaluation tool (Chaparro 2016). We like the Leapfrog tool as it applies to adult hospitals (see our previous columns for July 27, 2010 “EMR’s Still Have a Long Way to Go”, June 2012 “Leapfrog CPOE Simulation: Improvement But Still Shortfalls”, March 2015 “CPOE Fails to Catch Prescribing Errors” and May 3, 2016 “Clinical Decision Support Malfunction”). The adult and pediatric tools assess the ability of a hospital’s CPOE system to identify potentially problematic orders. It was used to evaluate 41 pediatric hospitals over a 2-year period, assessing overall performance as well as decision support categories (eg, drug-drug, dosing limits). CPOE systems at these hospitals overall were able to identify 62% of potential medication errors in the test scenarios, but ranged widely from 23-91% at individual institutions. The highest scoring categories included drug-allergy interactions, dosing limits, and inappropriate routes of administration. Looking at hospital performance longitudinally over time, they found that hospitals with longer periods since their CPOE implementation did not have better scores upon initial testing, but after initial testing there was a consistent improvement in testing scores of 4 percentage points per year. The latter exemplifies the ability of hospitals to learn from using the Leapfrog tool and improve their systems.
In our May 3, 2016 Patient Safety Tip of the Week “Clinical Decision Support Malfunction” we discussed the results of The Leapfrog Group’s most recent report on how adult hospitals perform on their CPOE evaluation tool (Leapfrog 2016). To fully meet Leapfrog’s standard, hospitals must:
In 2015 nearly two-thirds of hospitals (64%) fully met the standard, showing a considerable improvement compared to 14% in 2010. The hospitals also demonstrated improved performance in medication reconciliation. However, on the 2015 Leapfrog Hospital Survey, hospitals’ CPOE systems failed to flag 39% of all potentially harmful drug orders, or nearly two out of every five orders. The systems also missed 13% of potentially fatal orders.
Another recent, FDA-sponsored project analyzed medication errors potentially related to computerized prescriber order entry (CPOE). Amato and colleagues (Amato 2016) reviewed all patient safety medication reports that occurred in the medication ordering phase from 6 participating sites. They found that 51.9% of the medication error reports were related to CPOE. Of these, CPOE facilitated the error in 13.1% and potentially could have prevented the error in 86.9%. The most frequent CPOE issues involved transmission errors (eg. orders not being received in the appropriate place), erroneous dosing, and duplicate orders. These resulted in delays in medication reaching the patient, patients receiving duplicate drugs, or receiving a higher dose than indicated.
Also from the pediatric literature was a column on malpractice related to EHR’s (Oken 2016). Oken cited a medical liability insurer’s recent review of EHR-related malpractice claims showed that 42% were derived from system errors and 64% were from user factors. System errors include lack of interoperability of various systems and lack of clinical decision support in some systems. He notes that not all electronic prescribing programs in pediatric offices are able to validate the pediatric drug dosage, check drug interactions or include prescriptions from other physicians. Lack of pediatric functionalities in many EHRs, such as weight-based dosing, pose significant safety risks to children. On the user side, copying and pasting clinical information from previous medical encounters (sometimes known as “cloning”) can be a major risk. And somewhere in between system and user error is the problem of failure to recognize and appropriately follow up on reports that come back to the EHR.
A recent systematic review on the effects of healthcare IT on patient outcomes was informative (Brenner 2016). Using quite rigorous criteria for inclusion of studies, the authors found that such studies in the outpatient or long-term care settings were scant. The majority of studies demonstrating a positive impact of healthcare IT on patient outcomes came from inpatient settings and were likely single-center studies. And only 36% (25 of the 69 studies meeting criteria for inclusion) actually showed a positive effect on patient outcomes for the primary outcome measured. The rest showed mixed effects or no effect on patient outcomes. And one study showed a negative effect. Quality of the included studies was variable and most studies were observational or cohort studies rather than randomized controlled trials. The review really emphasizes the need for high quality studies with better design and larger populations, particularly on the outpatient side where the majority of care is rendered.
A recent AHRQ Web M&M case (McGreevey 2016) illustrated a CPOE-related problem that appeared after the transition from paper order sets to computer-based order sets. In the old paper-based world order sets for electrolyte replacement or correction included segments for hypokalemia and hypomagnesemia in close approximation (hypomagnesemia often occurs in patients who are hypokalemic). However, when the order sets were converted to the electronic format, attempts were made to simplify the information provided on individual computer screens. As a result, order options for magnesium no longer appeared on the same screen as those for potassium. In the case presented there was failure to address the hypomagnesemia when the patient’s hypokalemia was addressed. Loss of the visual cue to prompt assessment of the magnesium levels was considered contributory to the adverse outcome in the case.
That case highlights a problem we’ve previously discussed. The vulnerability of CPOE systems when changes are made to various components or files was also noted in our May 3, 2016 Patient Safety Tip of the Week “Clinical Decision Support Malfunction”. There we discussed a study from Brigham and Women’s Hospital (BWH) in Boston, which probably has the most robust CDSS of any healthcare organization anywhere (Wright 2016) and found several errors that were often very difficult to detect. They identified several contributing factors:
The studies collectively demonstrate that it is never enough to simply implement a CPOE system or e-prescribing system with clinical decision support systems and assume your patients will be safe from medication errors. Clearly, ongoing evaluation and assessment using validated tools are important to identify vulnerabilities that may be unexpected. We, of course, should expect better design and function from our IT vendors. The Wright study clearly shows that problems may arise even when the initial design and implementation were good yet changes to systems or files result in gaps that may go unidentified for long periods.
Other studies reinforce some other common errors related to computer order entry. Another recent AHRQ Web M&M case (Wears 2016) illustrated the “picklist” error (also known variously as the mouseclick error, drop-down list error, cursor error, stylus error, or juxtaposition error depending upon the setting and device being used) that we so often continue to see. A physician intending to order a CT scan of the abdomen and pelvis with oral contrast but without IV contrast mistakenly clicked on the CPOE order for a CT scan that included IV contrast. The patient subsequently developed a rise in serum creatinine, consistent with contrast nephropathy. Also, truncation of some items in picklists may lead to errors when physicians fail to scroll fully side-to-side or up-and-down.
Timely in this regard is a new report prepared for the Office of the National Coordinator for Health Information Technology on the safe use of picklists in ambulatory care settings (Rizk 2016). The report really focuses on two key issues:
While many wrong-patient errors occur from having multiple patient charts open simultaneously, picklist errors remain an important contributing factor to wrong-patient errors. The authors note that simply having adjacent items in a list can predispose to picklist errors but other design factors, such as pick list length and organization of the items in the list, may also contribute. They note that personalizing the list of patients to those that the provider has seen and allowing for sorting, filtering, and/or grouping the patients into categories can result in a shorter list of patients from which the provider can select, thus increasing the likelihood of selecting the correct patient.
We’ve done multiple columns on patient identification errors. You’ll find links to most of them and links to the literature in our January 19, 2016 Patient Safety Tip of the Week “Patient Identification in the Spotlight”. That includes discussions on the “ID-verify alert”, the “ID-reentry function”, and use of patient photographs that are also discussed in the new ONC report as ways to force active verification of patient identity.
List length is one factor contributing to wrong-medication errors. Obviously, the similarity of drug names is another. We’ve done many columns on LASA (look-alike, sound-alike) drug errors and the use of Tall Man lettering to help minimize these (see, for example, our December 1, 2015 Patient Safety Tip of the Week “TALLman Lettering: Does It Work?” and our July 2016 What's New in the Patient Safety World column “ISMP Updates TALLman Lettering List”).
Allowing ordering providers to customize lists of medications they most commonly use is another way to reduce wrong-medication errors. But keep in mind that unanticipated changes to lists can also be a source of errors. We’ve seen cases where a physician is used to choosing the first item from a medication category and then a vendor updates the software and a different medication is now first on the list. If the physician is not paying careful attention, he/she may just click on that first item.
Requiring input of the indication for each medication ordered is something we’ve long advocated. That helps, for example, when you accidentally click “digoxin” rather than “Dilantin”. Your clinical decision support tool would alert you that digoxin does not meet the indication of “anticonvulsant” that you entered. But one problem, particularly in hospitalized patients, is that you may not know the indication for which a patient had been started on previously and many medications (eg. beta blockers) have multiple different indications. But we still feel requirement of an indication is a useful safeguard in many cases.
Providing summaries of the orders entered in a session is another way to have the ordering provider review the orders and potentially catch errors.
The ONC report has several appendices that contain the recommendations and best practices to reduce the likelihood of picklist errors. Use them! They provide details for each of the following recommendations:
There is also a self-assessment form you can utilize to help identify your vulnerabilities. The report is replete with examples of various types of picklist errors and has excellent references.
The government incentives and “meaningful use” requirements have achieved the enviable goal of extending electronic health records to the vast majority of medical practices and hospitals. But the proliferation of systems has led to widespread variability of performance and multiple flaws that have impacted patient outcomes. Fortunately the ONC (Office of the National Coordinator for Health Information Technology) has just published a federal rule that will provide the ONC more authority to regulate and oversee the EHR tools that get certified via the Certified EHR Technology (CEHRT) program (DHHS 2016). The new rule basically focuses on catching flaws in EHRs already being used by providers and will address some of the usability, patient safety, and workflow design flaws found in the current generation of health IT tools. That is a welcome addition that should benefit patients, physicians, hospitals, and a whole host of stakeholders.
It’s time for us to begin realizing the full potential benefits that the world of healthcare IT promises.
See some of our other Patient Safety Tip of the Week columns dealing with unintended consequences of technology and other healthcare IT issues:
Chaparro JD, Classen DC, Danforth M, et al. National trends in safety performance of electronic health record systems in children’s hospitals. J Am Med Inform Assoc 2016; Epub ahead of print 2016 Sep 16
The Leapfrog Group. Hospitals’ Computerized Systems Proven to Prevent Medication Errors, but More is Needed to Protect Patients from Harm or Death. The Leapfrog Group 2016; April 7, 2016
Amato MG, Salazar A, Hickman TT, et al. Computerized prescriber order entry–related patient safety reports: analysis of 2522 medication errors. JAMIA 2016; First published online: 27 September 2016
Oken RL. Lessons learned from EHR-related medical malpractice cases. AAP News 2016; August 8, 2016
Brenner SK, Kaushal R, Grinspan Z, et al. Effects of health information technology on patient outcomes: a systematic review. J Am Med Inform Assoc 2016; 23: 1016-1036
McGreevey JD. Unexpected Drawbacks of Electronic Order Sets. AHRQ Web M&M. Cases & Commentaries. Published November 2016
Wright A, Hickman T-T T, McEvoy D, et al. Analysis of clinical decision support system malfunctions: a case series and survey. JAMIA 2016; First published online: 28 March 2016
Wears RL. Unintended Consequences of CPOE. AHRQ Web M&M. Cases & Commentaries. Published October 2016
Rizk S, Oguntebi G, Graber ML, Johnston D. Report on the Safe Use of Pick Lists in Ambulatory Care Settings. Issues and Recommended Solutions for Improved Usability in Patient Selection and Medication Ordering. (prepared for the Office of the National Coordinator for Health Information Technology). September 2016
DHHS (Department Of Health And Human Services). 45 CFR Part 170. RIN 0955–AA00. ONC Health IT Certification Program: Enhanced Oversight and Accountability. Federal Register 2016; 81(202): 72404-72471. Wednesday, October 19, 2016
November 29, 2016
Doubling Down on Double-Booked Surgery
A year ago, we did our first column on double-booked surgery (see our November 10, 2015 Patient Safety Tip of the Week “Weighing in on Double-Booked Surgery”). The practice, also known as concomitant or concurrent surgery or overlapping surgery (though subtle differences will be noted below), typically but not exclusively occurs in teaching hospitals. When it occurs in non-teaching hospitals it would be where a physician assistant, specifically credentialed and privileged by the hospital, is delegated to perform specific portions of a surgical procedure. Policies on such require the attending surgeon to be present during the critical portion of the surgery in each of the two cases.
Our 2015 column followed a Boston Globe investigative report (Abelson 2015) on double-booked surgery at the MGH (Massachusetts General Hospital) which raised serious concerns about the practice of attending surgeons in academic medical centers having two surgical cases ongoing simultaneously. Though the report was as much about hospital politics and power struggles and the manner in which we educate and train our next generation of surgeons, it exposes a controversial patient safety issue in addition to the ethical issue that patients are seldom told that their surgeon might not be in the room for the who procedure. In our prior column we also noted comments from multiple other sources and the MGH’s review of its own cases.
Since that time the American College of Surgeons (ACS) has revised its policy statements pertaining to concurrent, simultaneous, or overlapping operations (American College of Surgeons 2016). That revision has some good points but leaves some others in limbo. First, it clearly states that the primary surgeon bears responsibility for the patient’s welfare throughout the operation. It notes that in true “concurrent” surgery, where the critical portions of two surgeries are being performed at the same time, it is not appropriate for the primary surgeon to be responsible for two patients in two different rooms. It then notes 2 forms of “overlapping” operations. The first is when the critical portions of the first surgery are complete and only the more routine procedures (such as wound closure), the primary surgeon may go to another room to initiate another operation, leaving a qualified practitioner in the first room to finish the procedure. The second would be when the primary surgeon leaves the first room (after completion of the critical portion) and begins performing the critical portion of the second case. In that circumstance, the primary surgeon must assign a second surgeon to be immediately available to the first case. It notes that the patient must be informed in either of the above circumstances.
In discussing “overlapping” surgeries it states that the primary surgeon must be present for the “critical or key components” of the operation. But it leaves determination of “critical or key components” up to the primary surgeon.
The ACS policy statement also notes that performance of overlapping procedures should not negatively impact the seamless and timely flow of either procedure.
The ACS policy statement also discusses delegation of part of the operation to qualified practitioners including, but not limited to residents, fellows, anesthesiologists, nurses, physician’s assistants, nurse practitioners, surgical assistants or another attending under his or her personal direction. However, the primary attending surgeon’s personal responsibility cannot be delegated. It also has statements about cases with multidisciplinary teams, circumstances when a surgeon might temporarily leave a room, and unanticipated circumstances.
The ACS policy statement notes that as part of the pre-operative discussion, patients should be informed of the different types of qualified medical providers that will participate in their surgery (assistant attending surgeon, fellows, resident and interns, physician assistants, nurse practitioners, etc.) and their respective role explained. If an urgent or emergent situation arises that require the surgeon to leave the operating room unexpectedly, the patient should be subsequently informed.
A viewpoint from Mello and Livingston (Mello 2016) took a generally favorable view of concurrent surgery but did a nice job of pointing out some of the risks involved. They note that problems may arise when responsibilities are not delegated to surgeons with appropriate skill or experience or when the supervising surgeon cannot reach the patient in a timely fashion to prevent an unexpected crisis from escalating. They note that some surgeries are too complex or risky or specialized to hand off and that not all surgeons are equally able to carry out the cognitive and physical demands of such multitasking.
Along those lines of thought, hospitals should really determine which types of surgery should never be allowed to be double-booked and should also consider which surgeons should be allowed to double-book. One might consider requiring demonstration of proficiency for new surgeons in the credentialing and privileging process before double-booking is allowed. But at the other end of the spectrum, the older surgeon whose surgical skills are still good but whose ability to multitask may be starting to deteriorate (you all know this surgeon but no one is willing to speak up), is a much more difficult situation. What objective criteria would you use to tell that surgeon he/she can still do surgery but can no longer double-book?
There is actually a paucity of evidence in the literature for or against the practice of double-booked surgery. A recent retrospective review compared overlapping cases with non-overlapping cases for a variety of orthopedic surgical procedures performed in an academic ambulatory surgery setting (Zhang 2016). Of 3640 cases done between 2012 and 2015 about two-thirds were overlapping and one-third non-overlapping. Patient characteristics were comparable between the two groups. They found no difference in patient operating room time, procedure time, and 30-day complication rates between overlapping and non-overlapping surgery.
But the Zhang study was on an ambulatory surgery patient population. Patients in that setting are generally healthier than those having surgery as inpatients and the procedures done in the ambulatory surgery setting are generally less complicated, shorter, and safer than those done in the inpatient setting. Complication rates for orthopedic procedures in the ambulatory surgery setting are historically low. Moreover, the academic institution in the Zhang study (UCSF) had already implemented most of the stricter policies we’ve previously mentioned to make overlapping surgery less risky. You also must take into account the relatively small patient population here. The sort of disastrous adverse events that might arise as a result of overlapping surgery are quite infrequent, regardless of setting. That doesn’t mean they are not important. Wrong-site surgery is also rare but we now use Universal Protocol and other safety practices to avoid wrong-site surgery. We need to similarly use policies and procedures to minimize the chance that overlapping or concurrent surgery will result in adverse patient outcomes.
Also, in aggregate statistics such as those collected by Zhang et al. you can’t identify in which individual cases a complication might have been the result of double-booked surgery unless you do full case reviews on all cases with complications. There are even nuances in attribution when comparing complications in overlapping vs. non-overlapping surgery. Suppose you have a complication in a case in which a piece of faulty equipment contributed. That same equipment had been identified in a previous case as problematic but no post-op debriefing had occurred because the attending surgeon had left early to do an overlapping case. So no one formally flagged that equipment as faulty and it was cycled back into the usual equipment supply. Your current case (the one with the complication) is not a “double-booked” case but the complication will be attributed to this case and not to the previous double-booked case that missed the opportunity to identify the faulty equipment!
So even though we laud Zhang and colleagues for their study, we remain leery of any study that says “double-booked surgery is safe because we found no more complications in our double-booked cases compared to those that were not double-booked”.
In an editorial accompanying the Zhang study, Healy (Healy 2016) offers practical recommendations to help surgeons “do the right thing”. He proposes 5 important steps:
Regarding his point #4, after the Boston Globe article the Massachusetts Board of Registration in Medicine passed a regulation requiring that surgeon presence or absence in the room at various times be documented. In addition, the primary surgeon must identify the backup doctor who would assume responsibility if the first surgeon leaves the operating room.
As we noted above during discussion of the Zhang study, UCSF has already implemented many of these important elements. Practices at UCSF, noted in the Zhang study, require that the attending surgeon be present for the surgical timeout even when trainees are allowed to set up the case. And, most importantly, during informed consent the patient is told about the possibility of overlapping surgeries. That discussion takes place during a clinic visit (typically a week prior to the procedure) or in the preoperative area before any medication is given. And the attending physician identifies a fellow attending surgeon who is readily available where there might be overlap between two rooms.
Though the UCSF policy requires presence of the attending surgeon during the surgical timeout, we are not told anything about the pre-op “huddle” or pre-op briefing. We’ve done many columns on the utility of these. Our concern is that either the pre-op huddle may be skipped in one case in double-booked surgeries or that two pre-op huddles will be done at one time. If the latter is done, there is the risk that information from one patient or case will be transposed to the other case. That is probably actually more likely when the two surgical procedures are similar, as is the case in many if not most double-booked surgeries.
Informed consent must be transparent and presented in a manner that allows patients to understand the potential ramifications of their surgeon being in another room during any portion of their surgery. A recent viewpoint on informed consent in concurrent surgery (Langerman 2016) points out the “information asymmetry” involved, where “surgeons know much and our patients know little about what will happen during their operation.” Patients may not understand the implications of potentially spending extra time under anesthesia in the event their surgeon is delayed in responding to something in their case because he/she is doing surgery on another patient. Most patients in academic centers understand that physicians in training will actively participate in the surgery and likely improve the quality of their overall care. But they also likely expect that their primary surgeon will be present to oversee all aspects of their surgery.
Healy goes on to say, as we have said in our prior columns, that if he were to undergo surgery he would want his attending surgeon to be present in OR for the entire operation, regardless of whether he were performing or supervising various aspects of the procedure.
In our November 10, 2015 Patient Safety Tip of the Week “Weighing in on Double-Booked Surgery” we, of course, focused on the ethical issues involved (such as lack of informed consent) but we also pointed out some of the less obvious potential vulnerabilities that might occur with any form of “double-booked” surgery. We hope that you’ll go back to that column and read the sections on pre-op huddles and post-op debriefings, infection control issues, duration of surgery issues, surgeon focusing on two things at once (multitasking), and others.
We personally do not think that the definition of the “critical or key” components should be left to the discretion of the individual surgeon. Undoubtedly you will get different definitions from different surgeons. And if there is a case with complications that goes to litigation, you can bet that the lawyers will ask surgeon 1 why his/her definition was different from the definitions used by surgeons 2, 3, 4, etc. We feel strongly that there must be definitions that are uniform for each of the surgical procedures done within a department and across departments when the same procedure is done by multiple departments. (Definitions set by the “hospital” would really have to rely upon the expertise of department chairs, anyway.) Likewise, we would hope that each specialty society will help develop such definitions so that regulatory bodies don’t have to step in and develop such for them.
And for all you who would delegate wound closure as “routine, not requiring special expertise” what would you do in the following real-life scenarios if the primary surgeon is now in another room doing a “critical” part of that second surgery:
Another gray area is the definition of “immediately available” for the other surgeon covering in case of emergency. (In fact, we suggest that you might as part of your quality management program occasionally try to get hold of that covering physician and see how long it actually takes for him/her to get to the OR.)
We admit it – we don’t like the practice of any form of double-booked surgery other than in emergency cases. We’ve heard all the rationales and excuses used by physicians and hospitals for doing double-booked surgery:
Yes, we’re all for cost-effective medicine and understand the importance of training each new generation of surgeons. But when you read between the lines the fiscal incentives are still driving the practice of double-booked surgery.
Sorry, we’re with Healy on this – if we need surgery we want to know that our primary surgeon is going to be in the room for the entire procedure, even if he/she is just supervising the “non-critical” portions delegated to others. We suspect most patients would also want this.
Abelson J, Saltzman J, Kowalcyzk L, Allen S. Clash in the Name of Care. Boston Globe October 26, 2015
ACS (American College of Surgeons). Statements on Principles. Revised April 12, 2016
Mello MM, Livingston EH. Managing the Risks of Concurrent Surgeries. JAMA 2016; 315(15): 1563-1564
Zhang AL, Sing DC, Dang DY, et al. Overlapping Surgery in the Ambulatory Orthopaedic Setting. J Bone Joint Surg Am, 2016; 98 (22): 1859-1867
Healy WL. Overlapping Surgery: Do the Right Thing. Commentary on an article by Alan L. Zhang, MD, et al.: “Overlapping Surgery in the Ambulatory Orthopaedic Setting”. J Bone Joint Surg Am, 2016; 98 (22): e101
Langerman A. Concurrent Surgery and Informed Consent. JAMA Surg 2016; 151(7): 601-602
December 6, 2016
Postoperative Pulmonary Complications
Postoperative pulmonary complications are associated with increased morbidity and mortality, prolonged hospital stays, and increased costs. A few recent studies have demonstrated that these are common, sometimes may go undetected, and even the milder ones have clinically significant implications.
One recent study (Fernandez-Bustamante 2016) notes that postoperative pulmonary complications are heterogeneous in their pathophysiology, severity, and reporting accuracy. The researchers performed a multicenter prospective observational study in 7 US academic institutions of patients with ASA physical status of 3 who had noncardiothoracic surgery requiring 2 hours or more of general anesthesia with mechanical ventilation. This included 1202 patients who underwent predominantly abdominal, orthopedic, and neurological procedures. At least 1 postoperative pulmonary complication occurred in 33.4% of patients. This included the need for prolonged oxygen therapy by nasal cannula (19.6%) and atelectasis (17.1%). Patients with 1 or more postoperative pulmonary complications, even mild, had significantly increased early postoperative mortality, intensive care unit (ICU) admission, and ICU/hospital length of stay. The authors conclude that mild frequent postoperative pulmonary complications (eg, atelectasis and prolonged oxygen therapy need) deserve increased attention and intervention for improving perioperative outcomes.
Another study (Sun 2015) assessed oxygen saturation continuously, in a manner that was blinded to clinicians, in patients who had undergone noncardiac surgery. Those authors noted that on a typical post-op ward vital signs are recorded at 4-6 hour intervals, including oxygen saturations that are measured on a “spot” basis with pulse oximeters. Moreover, they also note that nurses often respond to poor saturation values by encouraging patients to breathe deeply until a near-normal saturation value is obtained and then record that value in the medical record. Their study found that that prolonged hypoxemic episodes were common. 37% of patients had at least one episode of oxygen saturation <90% lasting an hour or more and that nurses missed 90% of hypoxemic episodes detected by the blinded continuous monitoring in which oxygen saturation was <90% for at least one hour.
We’ve also noted in our numerous columns on obstructive sleep apnea (OSA) that patients who have hypoventilation when sleeping often have normal ventilation and normal oxygen saturation when aroused, such as when nursing records vital signs. So they often have normal oxygen saturations recorded in the medical record.
The Sun study does note that continuous monitoring of oxygenation was difficult. They used a system that was somewhat bulky and mounted on an IV pole and this significantly limited patient ambulation, causing many patients to discontinue the monitors. This may have led to an overestimation of hypoxemic events, as healthier patients may have disconnected them and ambulated early. Newer wrist-mounted systems that communicate wirelessly with hospital monitoring systems may alleviate this.
In an accompanying editorial, Robert Stoelting from the Anesthesia Patient Safety Foundation (Stoelting 2015) notes that the APSF recommends that all post-op patients receiving opioids be monitored with continuous pulse oximetry with data transmitted wirelessly to a qualified health care professional. APSF also recommends monitoring of ventilation if supplemental oxygen is needed to maintain an acceptable SpO2.
The message is clear: the risk of hypoxemia post-operatively is not confined to those patients we already knew were at high risk (such as patients with known or suspected OSA). In fact, there is even one study (Khanna 2016) which showed that the STOP-Bang questionnaire (which predicts the presence of OSA and also predicts postoperative complications) does not predict hypoxemia in adults recovering from noncardiac surgery. So there really is a need for continuous monitoring in most postoperative patients.
A recent investigative report “Dead in Bed” by On Your Side News 5 (Cleveland, Ohio) brought to public attention the problem of fatal complications in postoperative patients considered at low-risk (Regan 2016). It described several cases of fatalities related to opioid-induced respiratory depression in patients following surgery. It highlighted two root causes: (1) aggressive pain management by hospitals to achieve better patient satisfactions scores and (2) the substantial costs of implementing continuous monitoring systems. Yet it noted that implementation of such monitoring capabilities at Dartmouth-Hitchcock Medical Center (DHMC) was cost effective (AAMI 2013).
The Dartmouth-Hitchcock implementation resulted in significantly fewer rescues (from 3.5 to 1.2 rescues per 1,000 patients) and transfers to intensive care units (from 5.6 per to 2.9 per 1,000 patients). They estimated a cost savings of roughly $1.5 million just from reduction in ICU transfers (Taenzer 2012). DHMC subsequently implemented the continuous surveillance monitoring system on all its units, with variable cost saving based upon the underlying frequency of adverse events on each type of unit and the actual reductions in ICU transfers. Generally, results were more positive on surgical compared to medical units. And this was all accomplished with high levels of both patient acceptance and acceptance by clinical staff. Read the two documents (AAMI 2013, Taenzer 2012) to see the challenges and solutions the DHMC staff found in implementing this system. They also describe how they set parameters to be sensitive to clinically important deterioration yet avoiding alarm fatigue.
Since so many pulmonary complications occur in post-op patients who are receiving opioid therapy, we are always looking for ways to reduce the impact of opioid therapy. Many have had the impression that such complications are fewer when short-acting opioids are used compared to long-acting ones. So a comparative study was done (Belcher 2016). Belcher and colleagues looked at patients on PCA pumps treated with fentanyl (short-acting opioid) vs. morphine or hydromorphone (longer-acting opioids) and found that the long-acting patient-controlled opioids were not associated with increased hypoxemia during the first 2 postoperative days during which the study was done.
The best way to avoid opioid-induced respiratory depression is obviously to avoid opioids or to use lower doses. Multimodal analgesia is one of the best ways to accomplish this (see our February 19, 2013 Patient Safety Tip of the Week “Practical Postoperative Pain Management”). That includes use of multiple non-opioid analgesics with different modes of action (eg. acetaminophen and an NSAID) plus local or regional nerve blocks. And, of course, avoiding use of concomitant drugs that depress respiration (eg. benzodiazepines) is equally important.
Ironically, one of the risk factors for some pulmonary complications is pain itself. It may impair the ability to cough, thus predisposing patients to atelectasis or pneumonia. Or pain may limit mobilization and early ambulation. In fact, the editorial (Haines 2016) accompanying the Fernandez-Bustamante study pointed out that the rate of postoperative pulmonary complications was actually higher in the group who underwent a combined anesthetic approach, including regional anesthesia. The reason for that is not readily apparent. But the lesson is that we need to find a happy medium between adequate management of pain and avoiding the respiratory depressant effects of our pain management approaches.
Large percentages of post-op patients also receive supplemental oxygen. While some (Hopf 2016) suggest even wider use of supplemental oxygen in this population, we always caution that supplemental oxygen may delay recognition of opioid-induced respiratory depression if one is not using capnographic monitoring.
In our October 11, 2016 Patient Safety Tip of the Week “New Guideline on Preop Screening and Assessment for OSA” we noted that the Canadian Agency for Drugs and Technologies in Health (CADTH) in 2016 did an analysis of end-tidal CO2 monitoring in the hospital setting (CADTH 2016). Though admitting that high level evidence of efficacy is limited, they performed an exploratory analysis which concluded that for patients in serious or critical condition and for patients with obstructive sleep apnea or receiving high doses of opioids in post-operative care, use of end-tidal CO2 monitoring is likely less costly and more effective than standard monitoring.
Given the significance of postop pulmonary complications it seems clear that implementation of continuous monitoring systems is critical and that we cannot just limit such to those patients who we suspect are at highest risk. The limited literature available on cost effectiveness of such systems would certainly suggest that these are investments well spent.
Other Patient Safety Tips of the Week pertaining to opioid-induced respiratory depression and PCA safety:
Fernandez-Bustamante A, Frendl G, Sprung J. Postoperative Pulmonary Complications, Early Mortality, and Hospital Stay Following Noncardiothoracic Surgery. A Multicenter Study by the Perioperative Research Network Investigators. JAMA Surg 2016; Published online November 9, 2016
Sun Z, Sessler DI, Dalton JE, et al. Postoperative Hypoxemia Is Common and Persistent: A Prospective Blinded Observational Study. Anesthesia & Analgesia 2015; 121(3):709-715, September 2015
Stoelting RK. Continuous Postoperative Electronic Monitoring and the Will to Require It. Anesthesia & Analgesia 2015; 121(3):579-581, September 2015
Khanna AK, Sessler DI, Sun Z, et al. Using the STOP-BANG questionnaire to predict hypoxaemia in patients recovering from noncardiac surgery: a prospective cohort analysis. Br. J. Anaesth 2016; 116 (5): 632-640
Belcher AW, Khanna AK, Leung S, et al. Long-Acting Patient-Controlled Opioids Are Not Associated With More Postoperative Hypoxemia Than Short-Acting Patient-Controlled Opioids After Noncardiac Surgery: A Cohort Analysis. Anesthesia & Analgesia 2016; 123(6): 1471-1479, December 2016
Regan R, Assad S. Dead in bed: A deadly hospital secret. Healthy patients dying within hours of surgery. News 5 (Cleveland) 2016; November 18, 2016
AAMI Foundation Healthcare Technology Safety Institute. Safeguarding Patients With Surveillance Monitoring. The Dartmouth-Hitchcock Medical Center Experience. 2013
Taenzer AH, Blike GT. Postoperative monitoring—The Dartmouth experience. ASPF Newsletter 2012; 27(1): 1, 3–4, 21 (Spring-Summer 2012)
Haines KL, Agarwa S. Postoperative Pulmonary Complications—A Multifactorial Outcome. JAMA Surg 2016; Published online November 9, 2016
Hopf HW. Preventing Opioid-Induced Postoperative Hypoxemia: No Simple Answer? Anesthesia & Analgesia 2016; 123(6): 1356-1358, December 2016
CADTH (Canadian Agency for Drugs and Technologies in Health). Capnography for Monitoring End-Tidal CO2 in Hospital and Pre-hospital Settings: A Health Technology Assessment. Ottawa: CADTH 2016 (CADTH health technology assessment; no.142); March 2016
December 13, 2016
More on Double-Booked Surgery
It’s only been two weeks since our last column on double-booked surgery (see our November 29, 2016 Patient Safety Tip of the Week “Doubling Down on Double-Booked Surgery”) but already there have been two significant publications regarding the practice.
We previously noted the paucity of evidence in the literature for or against the practice of double-booked surgery. In our November 10, 2015 Patient Safety Tip of the Week “Weighing in on Double-Booked Surgery” we noted Massachusetts General Hospital’s review of its own cases. And in our November 29, 2016 Patient Safety Tip of the Week “Doubling Down on Double-Booked Surgery” we highlighted the study done by Zhang and colleagues at UCSF comparing overlapping cases with non-overlapping cases for a variety of orthopedic surgical procedures performed in an academic ambulatory surgery setting (Zhang 2016). The latter found no difference in patient operating room time, procedure time, and 30-day complication rates between overlapping and non-overlapping surgery.
Now a new retrospective review has compared overlapping surgery with nonoverlapping surgery at the Mayo Clinic (Hyder 2016). Over 10,000 cases of overlapping surgery were matched to a similar number of nonoverlapping surgeries. Adjusted odds ratio for inpatient mortality was greater for nonoverlapping procedures (adjusted odds ratio, OR = 2.14 vs overlapping procedures) and length of stay and morbidity were no different.
That’s reassuring in that it likely means that the overall occurrence of adverse events related to double-booked or overlapping cases is small. The frequency of retained surgical items or wrong-site surgery is also small but that doesn’t mean we don’t need to take steps to prevent such adverse events. The same applies to double-booked or overlapping surgery. The Hyder review also cannot conclude that there were no adverse events related to overalapping surgery since they did not do full case reviews on all cases. And, while they did the best they could in matching overlapping cases to nonoverlapping cases, we don’t know why the latter were done without overlapping. There may well have been a selection bias in which some factor not accounted for in the risk adjustment led the surgeons to schedule these cases as nonoverlapping. And you’ll recall in our November 29, 2016 Patient Safety Tip of the Week “Doubling Down on Double-Booked Surgery” we also described a scenario where as complication that could have been prevented had a post-op debriefing been done for one case of an overlapping surgery actually gets attributed instead to a nonoverlapping case. And, lastly, the results from a single academic center may not be generalizable to other academic centers or to non-teaching venues.
In addition, the Boston Globe (Saltzman 2016) recently noted an unpublished study by an assistant professor of surgery at the University of Toronto found an increased risk for postoperative complications in concurrent surgery for hip fractures. The study, which used data from about 100 hospitals, compared about 1,000 concurrent hip surgeries with 1,000 that were not performed simultaneously from 2009 to 2014. They noted that the longer the overlap, the greater the rate of complications. From the Globe article, however, it is not clear whether these surgeries were concurrent or overlapping, an important distinction as we’ll note below under definitions.
The second, and perhaps more significant, publication comes not from traditional medical literature but rather from the Senate Finance Committee! You may recall that, after the 2015 Boston Globe investigative report (Abelson 2015) on the practice of double-booked surgery, the Senate Finance Committee, which oversees CMS (Centers for Medicare & Medicaid Services), launched an investigation into double-booked surgery. It has just released a report on the findings of that investigation (Senate Finance Committee 2016). That committee solicited responses from 20 academic medical centers regarding a variety of issues surrounding double-booked surgery plus received testimony from CMS, The Joint Commission, the American College of Surgeons (ACS), AHRQ, the HHS OIG, and multiple other stakeholders.
After the American College of Surgeons issued its position/guidance on concurrent and overlapping surgery (ACS 2016) all of the 20 medical centers responding to the Senate committee had either modified their existing policies, adopted new policies, or were in the process of adopting new policies on double-booked surgery. The Senate committee reviewed those policies and other key issues and, while generally comfortable with the progress made to date, had some additional recommendations.
Hereafter, we’ll refer to “overlapping” surgery. The definition of “concurrent” surgery is a practice in which a surgeon is participating in the “critical portion(s)” of 2 cases simultaneously. The ACS and the Senate committee and pretty much all parties agree that “concurrent” surgery should never be performed.
The Senate committee specifically looked to see if the hospital policies conformed to the ACS guidance on the following:
Under the definitions of concurrent and overlapping surgeries, they wanted to see that “concurrent” surgery was defined and specifically prohibited. They also looked to see that hospitals used the ACS definitions for the 2 types of “overlapping” surgeries (see our November 29, 2016 Patient Safety Tip of the Week “Doubling Down on Double-Booked Surgery” for those definitions from the ACS). Half the respondent hospitals used the ACS definitions but several had used definitions that were more vague.
They drew special attention to one hospital policy that required department chairs allow surgeons to conduct overlapping surgery only after reviewing the surgeons’ outcome and quality data. In our November 29, 2016 Patient Safety Tip of the Week “Doubling Down on Double-Booked Surgery” we recommended that such review be conducted as part of both the credentialing and privileging process for new surgeons and for continuation of privileges for “overlapping” surgeries for current surgeons, keeping in mind that some older surgeons may maintain their surgical skills even as their ability to multitask deteriorates.
As you might expect, there was more variability when it came to defining “critical portions” of overlapping surgeries. Basically, both CMS and the ACS guidance leave that definition up to the individual surgeon. Most of the hospital policies reviewed by the Senate committee either did not define the critical portions or left it up to the attending physician. A few hospitals, however, did develop lists of procedures (usually by department) and their critical components. The report also notes that discussion of the “critical portions” could be part of the pre-op “huddle” or surgical “time out” and could also be written on the OR white board.
The Senate report notes that both CMS and the ACS generally consider opening and closing of the surgical site as not critical. But in our November 29, 2016 Patient Safety Tip of the Week “Doubling Down on Double-Booked Surgery” we gave real-life examples of some instances where circumstances identified after wound closure would likely merit return of the attending surgeon, with resultant increases in patient time under anesthesia.
The Senate report recognizes that the optimal manner of defining “critical portion” is wanting. But it does find merit in the approach where “surgical departments within a hospital’s medical staff develop guidelines that identify critical components of particular procedures while accounting for the individualized clinical judgment of the surgeon”. We feel strongly that there must be definitions that are uniform for each of the surgical procedures done within a department and across departments when the same procedure is done by multiple departments. (Definitions set by the “hospital” would really have to rely upon the expertise of department chairs, anyway.) Likewise, we would hope that each specialty society will help develop such definitions so that regulatory bodies don’t have to step in and develop such for them.
When overlapping surgery is performed, there should be designation of a backup surgeon who will be “immediately available” to intervene if the original attending surgeon is doing other surgery. Defining “immediately available”, as anticipated, was controversial. There was wide variation in the timeframes and locations in the policies of respondent hospitals. A third simply stated the surgeon must be “on campus”, which does not specify how readily he/she could respond. Some did not define immediately available at all. Others noted specific timeframes, such as 5 minutes or 15 minutes. The Senate report notes that neither CMS nor the ACS defined the term adequately. The ACS guidance does state the surgeon should be “reachable through a paging system or other electronic means, and able to return immediately to the operating room.”
The Hyder study (Hyder 2016), in describing overlapping surgery as performed at the Mayo Clinic, noted that “Each surgical specialty operates in dedicated operating room cores with multiple surgeons of the same specialty present throughout the business day; therefore, second surgeons are available to assist when needed.” That’s simply not good enough. A specific surgeon needs to be designated for each such overlapping case and that surgeon must not be doing activities that would preclude him/her from immediately going to the OR case in need of help (nor jeopardizing any other patient he/she may have been involved with prior to the call for help).
The Senate report notes that some hospitals set additional expectations for the backup surgeon. For example, he/she should be credentialed/privileged to perform the procedure being done, be willing to serve as backup, and be fully aware of the responsibility. The ACS apparently testified that some surgical fellows, with appropriate training, could be qualified to serve as the backup surgeon. We especially like what some policies require regarding communication about the backup surgeon:
The section of the Senate committee report dealing with informed consent is quite useful. It makes it clear that patients must be informed that their surgeon will not be in the operating room for parts of their surgery. But their review of informed consent documents found only 3 in which the consent forms explicitly stated the patient was scheduled to have overlapping surgery and that their surgeon would not be present for portions of their surgery. Many hospitals used wording too vague, such as their surgeon “may” be involved in other surgeries. In addition, 6 hospitals had wording that other providers may perform portions of their surgery without mentioning that their attending surgeon might not be present for those portions.
Moreover, it emphasizes that patients must be made aware of this in a manner in which they fully comprehend the implications and have both the ability to ask questions and refuse to have overlapping surgery. They cite an informative Health Affairs Blog by Dr. James Rickert dealing with informed consent in such cases (Rickert 2016). Rickert discusses the problems of ensuring patients truly understand what is told to them during informed consent and suspects that in discussing overlapping surgery “Euphemisms, incomplete information, and oblique discussions will be the norm.” It is clear that this discussion must take place at a time when the patient would have adequate time to digest the information, ask questions, and be able to cancel the surgery if desired. So having the discussion on the day of surgery is a no-go. Some of the hospitals included a specific time period, such as “at least 24 hours prior to the surgery”, but many left the wording vague such as “sufficiently prior to” surgery.
Some hospitals included in their general surgery consent a place for a patient to initial or sign that he/she understands their surgeon may be absent for a portion of their surgery. The report provides an excellent example the specific text of a paragraph one hospital uses on its form that must be signed by patients only in cases where overlapping surgery applies. Rickert notes that when surgery is first discussed, surgeons should tell patients if they practice simultaneous surgery, and explain what this will mean for them in the operating room. Because surgery schedules for elective procedures are usually done weeks or even months ahead of time, patients would then have sufficient time to find another surgeon if they are uncomfortable with the practice of simultaneous surgery. You’ll also recall from our November 29, 2016 Patient Safety Tip of the Week “Doubling Down on Double-Booked Surgery” the practice at UCSF in the Zhang study (Zhang 2016) typically involved such discussion during a clinic visit, typically a week prior to surgery and in the editorial accompanying the Zhang study, Healy (Healy 2016) recommended obtaining specific informed consent at least 2 weeks prior to the operation.
Our November 29, 2016 Patient Safety Tip of the Week “Doubling Down on Double-Booked Surgery” also cited a viewpoint on informed consent in concurrent surgery (Langerman 2016) which pointed out the “information asymmetry” involved, where “surgeons know much and our patients know little about what will happen during their operation.” Patients may not understand the implications of potentially spending extra time under anesthesia in the event their surgeon is delayed in responding to something in their case because he/she is doing surgery on another patient. Most patients in academic centers understand that physicians in training will actively participate in the surgery and likely improve the quality of their overall care. But they also likely expect that their primary surgeon will be present to oversee all aspects of their surgery.
We would also like to point out a surgeon should never refuse to perform surgery on a patient who refuses to consent to overlapping surgery. It may be appropriate to let a patient know his/her surgery may not be able to be scheduled as soon if it is not overlapping. But to refuse to do the surgery as a nonoverlapping case would be unethical. We feel that including specific wording to that effect in the informed consent document or the educational materials provided to the patient should be part of every hospital’s policy on overlapping surgery. And hospitals obviously need to make it clear to their staff that such refusal would not be tolerated.
Perhaps the strongest recommendations in the Senate committee report deal with ensuring compliance with policies. The report stresses that developing policies on overlapping surgery are an important first step but that training all staff to ensure they understand the policies and then overseeing that the policies are adhered to are critical steps. They liked language similar to that used by some hospitals:
They also liked language used by some hospitals to describe roles played by others staff in ensuring compliance with the policies:
Monitoring surgeon location and tracking the critical portions of the surgical procedures is also considered important in the Senate committee report. Many hospital policies simply used the CMS billing requirement that the surgeon document in the medical record that he/she was present for the critical portion(s) of the surgery. We previously noted the Massachusetts Board of Registration in Medicine proposal requiring that surgeon presence or absence in the room at various times be documented. We like the latter idea. We actually have proposed hospitals record entry and exit of all OR personnel in attempt to reduce opening and closing of OR doors (which may predispose to infections) as described in our July 26, 2016 Patient Safety Tip of the Week “Confirmed: Keep Your OR Doors Closed”.
In our November 29, 2016 Patient Safety Tip of the Week “Doubling Down on Double-Booked Surgery” we also suggested that you might as part of your quality management program occasionally try to get hold of that “backup” physician and see how long it actually takes for him/her to get to the OR.
The Senate committee was also concerned that hospitals need to specify how complaints about surgeries from patients or staff would be addressed.
Missing from the Senate committee report, from our perspective, is discussion about pre-op huddles/briefings and post-op debriefings. We’ve discussed these important issues in our Patient Safety Tips of the Week for November 10, 2015 “Weighing in on Double-Booked Surgery” and November 29, 2016 “Doubling Down on Double-Booked Surgery”.
The Senate committee report does make mention of the surgical time out only in that the “time out” should include identification of the backup surgeon. It also notes that discussion of the “critical portions” could be part of the pre-op “huddle” or surgical “time out” and could also be written on the OR white board. We also think that the surgeon should announce during both the pre-op “huddle” and surgical “time out” that he/she will be doing an overlapping case and when staff can expect him/her to leave the current case. For the second case, the surgeon obviously needs to be present for the surgical “time out”. But what about the pre-op “huddle” for that second case? Is it skipped? Is it done prior to the first case? And, remember, if you do two pre-op huddles back-to-back you may be vulnerable to transposing information or intents between cases, particularly when the cases are similar procedures.
The Senate committee report tried to get an estimate of the scope of overlapping surgery across the US. But they found such statistics are difficult to come by. At respondent hospitals the percentages of overlapping cases ranged from less than 1% to 33% of all surgeries. The percentage of overlapping cases was even higher for some specific surgeons.
The Senate report also notes that neither CMS nor The Joint Commission has specifically investigated overlapping surgery in their surveys. The HHS OIG has audited billing practices at teaching hospitals and has found several violations over the years, resulting in fines for those hospitals. So the Senate Finance Committee has also recommended that CMS and the HHS OIG review compliance with billing practices related to overlapping surgery. They also note that the CMS billing guidelines only apply to teaching hospitals. The Senate committee recommends that CMS also review whether those billing requirements should also be applied to non-teaching venues where overlapping surgery may be done (private hospitals, ambulatory surgery centers, etc.).
The recent Boston Globe article (Saltzman 2016) also included a comment from the chairman of surgery at the University of Michigan, stating that “the practice benefits only the surgeons who get to do it by increasing their productivity. It is inefficient for all other medical staff, he said, including other surgeons who lose operating room time.” We hadn’t quite thought about it in that way but it is really in keeping with our conviction that the fundamental driving force for double-booked surgery is the financial incentive.
As before, we personally would not consent to any form of double-booked surgery and expect our attending surgeon to be present at our procedure even when portions of the surgery are being performed by residents, fellows, or other personnel. While we would hope most hospitals eliminate or minimize any form of double-booked surgery, we would expect those hospitals allowing overlapping surgery meet the positive elements noted in this column.
For those of you who plan to allow overlapping surgery at your institution, we offer the the “Overlapping Surgery Checklist” to help you plan for safe implementation.
See all our columns on double-booked, concurrent, or overlapping surgery:
Zhang AL, Sing DC, Dang DY, et al. Overlapping Surgery in the Ambulatory Orthopaedic Setting. J Bone Joint Surg Am, 2016; 98 (22): 1859-1867
Hyder JA, Hanson KT, Storlie CB, et al. Safety of Overlapping Surgery at a High-volume Referral Center. Annals of Surgery 2016; Published ahead of print (Post Author Corrections): December 5, 2016
Saltzman J, Abelson J. Senate committee calls for ban on surgeons conducting simultaneous operations. The Boston Globe 2016; December 6, 2016
Abelson J, Saltzman J, Kowalcyzk L, Allen S. Clash in the Name of Care. Boston Globe October 26, 2015
Senate Finance Committee. Concurrent and Overlapping Surgeries: Additional Measures Warranted. A Senate Finance Committee Staff Report 2016; December 6, 2016
ACS (American College of Surgeons). Statements on Principles. Revised April 12, 2016
Rickert J. A Patient-Centered Solution To Simultaneous Surgery. Health Affairs Blog 2016; June 14, 2016
Healy WL. Overlapping Surgery: Do the Right Thing. Commentary on an article by Alan L. Zhang, MD, et al.: “Overlapping Surgery in the Ambulatory Orthopaedic Setting”. J Bone Joint Surg Am, 2016; 98 (22): e101
Langerman A. Concurrent Surgery and Informed Consent. JAMA Surg 2016; 151(7): 601-602
Our own “Overlapping Surgery Checklist”.
Print “More on Double-Booked Surgery”
December 20, 2016
End-of-Rotation Transitions and Mortality
Transitions of care are periods of vulnerability of patients to a variety of errors and adverse events. We usually think of such transitions as when a patient moves from one venue to another. But in academic medical centers we also see a different sort of transition of care: the end-of-rotation change in the whole caregiving team (interns, residents, attendings). Note that similar changes also commonly take place in non-academic settings, for instance, when hospitalists rotate.
A recent study done at 10 academic-affiliated VA hospitals looked at mortality rates associated with housestaff end-of-rotation shifts on internal medicine services between 2008 and 2014 (Denson 2016). The data were stratified by type of transition (intern only, resident only, or intern + resident). Apparently change of attending physician was not considered.
Adjusted hospital mortality was significantly greater in transition vs control patients for the intern-only group (3.5% vs 2.0%) and the intern + resident group (4.0% vs 2.1%) but not for the resident-only group (3.3% vs 2.0%). Adjusted 30-day and 90-day mortality rates were greater in all transition vs control comparisons. Because ACGME duty hour regulations changed in 2011 they also looked at whether there were changes in mortality rates related to those. They found that duty hour changes were associated with greater adjusted hospital mortality for transition patients in the intern-only group and intern + resident group than for controls. They note that the magnitude of the findings was generally greater in relation to intern rotations than resident rotations. They note that interns are the least experienced physicians, thus likely more prone to errors in managing patients, and the work hour restrictions may have resulted in their having less time to prepare for such transitions.
The accompanying editorial (Arora 2016) notes that some of the excess mortality is likely unrelated to the transition of care. They note that sicker, more complex patients are more likely to be present during an end-of-rotation transition of care. Such patients are more likely to die so the statistics may be skewed in such cases. They also note that there may be socioeconomic factors that result in delayed discharges in many patients whose stay overlaps an end-of-rotation transition and those socioeconomic factors may influence downstream mortality. But they concur that we need to take steps to reduce any adverse impacts such end-of-rotation changes may cause.
Back in the mid-1990’s at the Erie County Medical Center we recognized that month-to-month transitions of care on our academic units were problematic even when we staggered the times that attending physicians changed or staggered times when senior residents would change relative to interns and junior residents. Thinking back to your housestaff days, you’ll recall that it was always much more difficult to manage “inherited” patients than brand new admissions. And that first day on a new service was always a nightmare. You might have to rapidly become familiar with 10 or more existing patients, even on a day when you were admitting new patients. Such transitions were problematic in terms of both patient outcomes and hospital lengths of stay.
Our solution: we developed a nurse case manager program (see our February 5, 2008 Patient Safety Tip of the Week “Reducing Errors in Obstetrical Care”). Our Director of Nursing, Karen Maricle, and I took 4 of our best RN’s and worked with them to develop the nurse case manager program. One nurse case manager was assigned to each of 4 general medicine teams. They provided the day-to-day and month-to-month continuity that was desperately needed. They became much more familiar not only with patients but also with the patients’ families and other support providers. They were especially helpful on days when residents had their continuity clinic and would be off the ward for several hours. And with advent of resident workhour restrictions in New York State the nurse case managers were the ones most knowledgeable about many patients on many days. Soon after we implemented the program as a pilot, other services began clamoring for their own nurse case managers and we expanded the program to other services. We found that the nurse case manager improved continuity of care tremendously, not only on a day-to-day basis, but also when teaching services would rotate on a monthly basis. This program was largely responsible for a substantial improvement in mortality rates, reduction in length of stay, and improvement in patient and family satisfaction. The resultant reduction in average length of stay more than offset the costs of the program. Adding such valuable resources can result in an overall net savings of both human and financial resources.
Another concept that helps is use of the “firm” system, variations of which most academic medical centers are probably already using. At Johns Hopkins we had several medical “firms” where the interns, residents, and attendings were assigned. Patients were also assigned to a firm. So a patient would always be seen by someone in that firm on the outpatient side and if they required hospitalization they would be admitted to that firm’s ward. The result was that for many patients you already knew much about them when you rotated onto the inpatient service.
Certain types of diagnostic error are probably more common in “inherited” patients. There is a tendency to accept the diagnoses that were being used by the team that just rotated off service so “anchoring” bias and the related concept of “premature closure” (see our November 29, 2011 Patient Safety Tip of the Week “More on Diagnostic Error”) may come into play. So you have to be very careful to make sure that you evaluate all new information on “inherited” patients, paying particular attention not to ignore “disconfirming” information that doesn’t quite fit with their working diagnoses. (We should also note, however, that such transitions may sometimes combat “anchoring” bias in that the incoming team is a “new set of eyes” that may question prior working diagnoses.)
Similarly, some of the subtleties of medication reconciliation may be lost in such transitions of care. Just as medication reconciliation should be done every time a patient moves from one level of care to another, you can make a case that it should be done each time there is transfer of care from one team to another.
The outgoing team also needs to clearly spell out what test results are “pending”. In our many columns on significant findings falling through the cracks (see the list below) we’ve noted that official reports (eg. imaging studies, pathology reports, etc.) may differ from preliminary reports. For example, the team may review a patient’s CT scan and consider it normal and describe it as normal in the patient chart. The teams change and no one notices that the official report from Radiology noted a suspicious incidental finding. The incoming team eventually discharges the patient without attention to that finding. That’s the reason that discharge summaries and off-service notes should always have a specific section for “studies done, result pending”. It’s also a reason why your Radiology department needs a system in place for flagging significant or unexpected findings with mechanisms to contact the right people for follow up.
It’s also important for the incoming team to become acquainted with family or others who will help care for patients after discharge. Often the rapport the outgoing team had developed with such caregivers is lost during the end-of-rotation transition. That was one area where our nurse case manager program was extremely valuable.
We don’t think that the findings of the Denson study are an anomaly. We suspect similar analyses at most hospitals (academic and nonacademic) may find similar adverse impacts of changes in continuity of the care team(s).
See also our other columns on communicating significant results:
Denson JL, Jensen A, Saag JS, et al. Association between End-of-Rotation Resident Transition in Care and Mortality Among Hospitalized Patients. JAMA 2016; 316(21): 2204-2213
Arora VM, Farnan JM. Inpatient Service Change: Safety or Selection? JAMA 2016; 316(21): 2193-2194
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September 30, 2014
More on Deprescribing
September 23, 2014
September 16, 2014
Focus on Home Care
September 9, 2014
September 2, 2014
August 26, 2014
August 19, 2014
August 12, 2014
August 5, 2014
Tip of the Week on Vacation
July 29, 2014
July 22, 2014
July 15, 2014
July 8, 2014
July 1, 2014
Interruptions and Radiologists
June 24, 2014
June 17, 2014
June 10, 2014
June 3, 2014
May 27, 2014
May 20, 2014
May 13, 2014
May 6, 2014
April 29, 2014
April 22, 2014
April 15, 2014
Specimen Identification Mixups
April 8, 2014
April 1, 2014
March 25, 2014
March 18, 2014
March 11, 2014
March 4, 2014
February 25, 2014
February 18, 2014
February 11, 2014
February 4, 2014
January 28, 2014
Is Polypharmacy Always Bad?
January 21, 2014
January 14, 2014
January 7, 2014
December 24-31, 2013
Tip of the Week on Vacation
December 17, 2013
December 10, 2013
December 3, 2013
November 26, 2013
November 19, 2013
November 12, 2013
November 5, 2013
October 29, 2013
October 22, 2013
October 15, 2013
October 8, 2013
October 1, 2013
September 24, 2013
September 17, 2013
September 10, 2013
September 3, 2013
August 27 2013
August 20 2013
August 13 2013
August 6, 2013
July 9-30, 2013
Tip of the Week on Vacation
July 2, 2013
June 25, 2013
June 18, 2013
June 11, 2013
June 4, 2013
May 28, 2013
May 21, 2013
May 14, 2013
May 7, 2013
April 30, 2013
April 23, 2013
April 16, 2013
April 9, 2013
April 2, 2013
March 26, 2013
March 19, 2013
March 12, 2013
March 5, 2013
February 26, 2013
February 19, 2013
February 12, 2013
February 5, 2013
January 29, 2013
January 22, 2013
January 15, 2013
January 8, 2013
January 1, 2013
December 25, 2012
Tip of the Week on Vacation
December 18, 2012
December 11, 2012
December 4, 2012
November 27, 2012
November 20, 2012
November 13, 2012
November 6, 2012
October 30, 2012
October 23, 2012
October 16, 2012
October 9, 2012
October 2, 2012
September 25, 2012
September 18, 2012
September 11, 2012
September 4, 2012
August 28, 2012
August 21, 2012
August 14, 2012
August 7, 2012
July 31, 2012
July 24, 2012
July 17, 2012
July 10, 2012
Tip of the Week on Vacation
July 3, 2012
June 26, 2012
June 19, 2012
June 12, 2012
June 5, 2012
May 29, 2012
May 22, 2012
May 15, 2012
May 8, 2012
May 1, 2012
April 24, 2012
April 17, 2012
April 10, 2012
April 3, 2012
March 27, 2012
March 20, 2012
March 13, 2012
March 6, 2012
February 28, 2012
February 21, 2012
February 14, 2012
February 7, 2012
January 31, 2012
January 24, 2012
January 17, 2012
January 10, 2012
January 3, 2012
December 20, 2011
December 13, 2011
December 6, 2011
November 29, 2011
November 22, 2011
November 15, 2011
November 8, 2011
November 1, 2011
October 25, 2011
October 18, 2011
October 11, 2011
October 4, 2011
September 27, 2011
September 20, 2011
September 13, 2011
September 6, 2011
August 30, 2011
August 23, 2011
August 16, 2011
August 9, 2011
August 2, 2011
July 26, 2011
July 19, 2011
July 12, 2011
July 5, 2011
June 28, 2011
June 21, 2011
June 14, 2011
June 6, 2011
May 31, 2011
May 24, 2011
May 17, 2011
May 10, 2011
May 3, 2011
April 26, 2011
April 19, 2011
April 12, 2011
April 5, 2011
March 29, 2011
The Silent Treatment:A Dose of Reality
March 22, 2011
March 15, 2011
March 8, 2011
March 1, 2011
February 22, 2011
February 15, 2011
February 8, 2011
February 1, 2011
January 25, 2011
January 18, 2011
January 11, 2011
January 4, 2011
December 28, 2010
December 21, 2010
December 14, 2010
December 6, 2010
November 30, 2010
November 23, 2010
November 16, 2010
November 9, 2010
November 2, 2010
October 26, 2010
October 19, 2010
October 12, 2010
October 5, 2010
September 28, 2010
September 21, 2010
September 14, 2010
September 7, 2010
August 31, 2010
August 24, 2010
August 17, 2010
August 10, 2010
August 3, 2010
Tip of the Week on Vacation
July 27, 2010
July 20, 2010
July 13, 2010
July 6, 2010
June 29, 2010
June 22, 2010
June 15, 2010
June 8, 2010
June 1, 2010
May 25, 2010
May 18, 2010
May 11, 2010
May 4, 2010
April 27, 2010
April 20, 2010
April 13, 2010
April 6, 2010
March 30, 2010
March 23, 2010
March 16, 2010
March 9, 2010
March 2, 2010
February 23, 2010
February 16, 2010
February 9, 2010
February 2, 2010
January 26, 2010
January 19, 2010
January 12, 2010
January 5, 2010
December 29, 2009
December 22, 2009
December 15, 2009
December 8, 2009
December 1, 2009
November 24, 2009
November 17, 2009
November 10, 2009
November 3, 2009
October 27, 2009
October 20, 2009
October 13, 2009
October 6, 2009
September 29, 2009
September 22, 2009
September 15, 2009
September 8, 2009
September 1, 2009
August 25, 2009
August 18, 2009
August 11, 2009
August 4, 2009
July 28, 2009
July 21, 2009
July 14, 2009
July 7, 2009
June 30, 2009
June 23, 2009
June 16, 2009
June 9, 2009
June 2, 2009
May 26, 2009
May 19, 2009
May 12, 2009
May 5, 2009
April 28, 2009
April 21, 2009
April 14, 2009
April 7, 2009
March 31, 2009
March 24, 2009
March 17, 2009
March 10, 2009
March 3, 2009
February 24, 2009
February 17, 2009
February 10, 2009
February 3, 2009
January 27, 2009
January 20, 2009
January 13, 2009
January 6, 2009
December 30, 2008
December 23, 2008
December 16, 2008
December 9, 2008
December 2, 2008
November 25, 2008
November 18, 2008
November 11, 2008
November 4, 2008
October 28, 2008
October 21, 2008
October 14, 2008
October 7, 2008
September 30, 2008
September 23, 2008
September 16, 2008
September 9, 2008
September 2, 2008
August 26, 2008
August 19, 2008
August 12, 2008
August 5, 2008
July 29, 2008
July 22, 2008
July 15, 2008
July 8, 2008
July 1, 2008
June 24, 2008
June 17, 2008
June 10, 2008
June 3, 2008
May 6, 2008
April 29, 2008
April 22, 2008
April 15, 2008
April 8, 2008
April 1, 2008
March 25, 2008
March 18, 2008
March 11, 2008
March 4, 2008
February 26, 2008
February 19, 2008
February 12, 2008
February 5, 2008
January 29, 2008
January 22, 2008
January 15, 2008
January 8, 2008
January 1, 2008
December 25, 2007
December 18, 2007
December 11, 2007
December 4, 2007
November 20, 2007
November 13, 2007
November 6, 2007
October 30, 2007
October 23, 2007
October 16, 2007
October 9, 2007
October 2, 2007
September 25, 2007
September 18, 2007
September 11, 2007
September 4, 2007
August 28, 2007
August 21, 2007
August 14, 2007
August 7, 2007
July 31, 2007
July 24, 2007
July 17, 2007
July 10, 2007
July 3, 2007
June 26, 2007
June 19, 2007
June 12, 2007
June 5, 2007
May 29, 2007
May 22, 2007
May 15, 2007
May 8, 2007
May 1, 2007
April 23, 2007
April 16, 2007
April 9, 2007
April 2, 2007
March 26, 2007
March 19, 2007
March 12, 2007
March 5, 2007
February 26, 2007