January 12, 2010           

Patient Photos in Patient Safety

Patient photographs are potential tools in patient safety that have attracted surprisingly little attention to date. In our July 28, 2009 Patient Safety Tip of the Week “Wandering, Elopements, and Missing Patients” we briefly mentioned using photographs of patients when broadcasting an alert for a missing patient. We recommend that you include in your IT system a digital photograph of patients you identify as being at risk for wandering and elopement. Many communities, often in conjunction with their local chapter of the Alzheimer Association, have programs where families provide photos of their relatives with Alzheimer’s Disease or other dementia to the local police department to facilitate searches when such individuals go missing.

We’ve often thought that inclusion of patient photographs would be a logical tool to use in avoiding wrong patient surgeries or mixups in medication administration. And we were surprised to see that many hospital electronic medical record programs lacked standardized fields for such photographs.

In fact, there are programs that have used patient photographs to reduce the risk of patient misidentification during medication administration (AHRQ Health Care Innovations Exchange). The JPS Health Network in Fort Worth, Texas implemented such a system on its psychiatry units. They first implemented it on adolescent psychiatry in 2000 then, based on success of that program, extended it to their adult psychiatry service in 2006. They noted that this additional method of correct patient identification is especially needed on psychiatry because patients frequently remove their wristband identifications and may be unable or unwilling to respond to questions at the time of medication administration. In the year after implementation on the adult unit, there were no misidentification errors on either unit. Reappearance of misidentification errors a year later led to a reeducation effort and such errors again fell to almost zero.

The AHRQ document nicely describes how JPS went about implementing the program. The resources needed for the program basically amount to a few digital cameras and some staff training. The cameras should be easy-to-use digital cameras. Nurses take a digital photograph of each patient at the time of admission and print one copy for the chart and a second for a 3x5 inch index card that includes the patient label (with patient’s name, date of birth, medical record number, and barcode). That index card then gets clipped to the patient’s MAR (medication administration record). Nurses then use the photograph as a second means of identifying the patient during medication administration (or other nursing activities). The first means of patient identification remains the more standard multiple-identifier method (they use verifying the patient’s name, date of birth and match on the barcode). Other healthcare workers, including physicians and phlebotomists, also use the photographs for patient identification.

On admission, the nurse taking the photograph explains to the patient the reason for the photography (i.e. to avoid patient misidentification) and assures them it will only be used for that purpose. The process is simple and inexpensive and has become a routine part of the admission process on the psychiatry units at JPS.

There are, of course, other advantages to using patient photographs in healthcare (aside from those that are used for clinical activities such as tracking wound healing, etc.). In our December 2008 What’s New in the Patient Safety World “Patient Photographs Improve Radiologists’ Performance” we noted a paper presented at the Radiological Society of North America’s annual meeting showing that inclusion of photographs of patients improved accuracy of radiologists’ reports. Putting a photograph of the patient aside their images on a PAC screen resulted not only in the radiologists feeling more empathy toward the patient but they also identified more incidental findings (the files were chosen because of incidental findings in this randomized study) without taking more time to review the images.

The American Association for Clinical Chemistry (AACC April 2009) reports some healthcare organizations are attaching patient photos to requisitions for Pap smears or other specimens that are being examined.

We think adding patient photographs to electronic medical records (EMR’s) could significantly improve patient safety in other ways as well. They might help prevent a physician from inadvertently ordering on the wrong patient during CPOE. In our May 20, 2008 Patient Safety Tip of the Week “CPOE Unintended Consequences – Are Wrong Patient Errors More Common?” we noted that many orders are now entered into CPOE from remote locations. Having a photograph of the patient at the top of each screen logically should help alert a physician that he/she may be entering that order on the wrong patient.

Patient photographs might also be used on patient identification cards issued by a healthcare system. This might help avoid “medical identify theft” or other fraudulent use of identification. Also, you’d be surprised at how issuing identity cards for your health system fosters loyalty to your system. We recall many years ago when our health system stopped issuing patient cards. The patients complained! They liked having them to carry around. It gave them a measure of security and sense of belonging. So don’t underestimate the potential value of such cards.

But are there downsides to using patient photographs? Though we have been unable to find any good examples in the literature (probably because of the paucity of any literature on use of patient photographs for patient safety), we can certainly anticipate there might be unintended consequences. Just like many other examples we have seen, it could happen that photographs of two patients get mixed up. For example, one might anticipate two patients being admitted around the same time. Each would get photographed. It is conceivable that someone might print out both photographs and erroneously transpose them into the charts or IT system. That is one reason you should never do anything intended for more than one patient simultaneously.

And what about those patients (eg. trauma patients) whose faces may not be recognizeable on admission? And all those babies in the nursery look the same to me! And some patients, particularly those with long stays, may have considerable changes in appearance over time.

And how do you ensure that your staff actually use the photos to aid in patient identification? In a FMEA performed at one institution (Skibinski et al 2007) it was found that in those patients with a wristband present and checked, a second form of patient verification (photograph, verification of birthdate, positive response to stated name, etc.) was not checked 30% of the time. So not only is training and reinforcement necessary but some audit function would be appropriate.

And one must protect patient photographs just as we protect any protected health information (PHI) in any healthcare system. That means strict HIPAA adherence and good auditing trails. You also need to check with your legal counsel locally to ensure that use of patient photos is compatible with all statutes and laws in your state.

We think that use of patient photos has tremendous potential to improve patient safety. But the logisitics, legal and privacy issues, measurable outcomes, and unintended consequences remain to be determined. We’d be interested to hear from any of you how you are using patient photos and whether you have encountered any unintended consequences.

References:

AHRQ Health Care. Innovations Exchange. Innovation Profile: Use of Photographs as Second Means of Identifying Patients on Psychiatry Units Virtually Eliminates Medication Errors Related to Misidentification.

http://www.innovations.ahrq.gov/content.aspx?id=2626

AACC. Clinical Laboratory News. April 2009. Patient Safety Focus: Disconnection from Patients and Care Providers 

Disconnection from Patients and Care Providers
A Latent Error in Pathology and Laboratory Medicine
An Interview with Stephen Raab, MD

http://www.aacc.org/publications/cln/2009/april/Pages/safety0409.aspx

Skibinski KA, White BA, Lin LI, et al. Effects of technological interventions on the safety of a medication-use system. Am. J. Health Syst. Pharm., Jan 2007; 64: 90 – 96

http://www.ajhp.org/cgi/search?sendit=Search&pubdate_year=&volume=&firstpage=&author1=skibinski+ka&author2=&title=&andorexacttitle=and&titleabstract=&andorexacttitleabs=and&fulltext=&andorexactfulltext=and&resourcetype=1,10&fmonth=Sep&fyear=1965&tmonth=Jan&tyear=2010&fdatedef=1+September+1965&tdatedef=1+January+2010&flag=&RESULTFORMAT=1&hits=10&hitsbrief=25&sortspec=relevance&sortspecbrief=relevance

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January 19, 2010           

Timeouts and Safe Surgery

The number of wrong site surgeries reported as sentinel events to The Joint Commission continues to increase annually. However, the number reported to the Pennsylvania Patient Safety Authority reporting system has shown 3 consecutive quarters of improvement, perhaps aided by a regional collaborative that was very successful. But they note that one report of wrong-site surgery in a hospital that previously had no cases, highlighting the continuing need for vigilance and proper safety systems even in organizations with a good track record of safety.

The use of the surgical “timeout” and the use of the surgical checklist are key to avoiding not only wrong-site surgery but also avoiding other perioperative complications. However, compliance with these processes is often suboptimal. Two recent papers have addressed some of the challenges. The first paper (Vats et al 2010) looked at the barriers and challenges encountered in implementation of the WHO Safe Surgery Checklist (see our July 1, 2008 Patient Safety Tip of the Week “WHO’s New Surgical Safety Checklist”) at their hospital. Like most hospitals, most nurses and anesthesiology staff were supportive of the checklist from the start but many surgeons were less enthusiastic. However, using local surgical champions helped win over those surgeons that were skeptical. They noted that the checklist process often took a long time at the beginning, primarily because lack of familiarity with the checklist required they read out each item in its entirety. With time, that became faster. For example, use of single word cues (eg. “antibiotics”) became useful. However, sometimes teams became so comfortable with the checklist that they began performing it by memory, sometimes omitting items. So teams were encouraged to use the paper checklist.

They did find some examples of “badly used checklist”. The WHO checklist has three parts. While the “sign-in” and “time-out” portions were usually completed, the “sign-out” portion (to be done before patient leaves the OR) was often not completed. Time pressures (when the surgeon or anesthesiologist felt that workflow was being delayed) would occasionally pressure nurses to cover items quickly. Dismissive replies (i.e. those replies that are affirmative but inaccurate) would often go unchallenged, a problem with hierarchy in the OR. And sometimes the checklist would be done when one of the key parties was absent.

Compliance with the checklist initially improved over time. However, when the research team ceased attending all operations, compliance fell. It improved when the research team again began attending all operations but fell again at the end of the research period, prompting another period of encouragement. The lesson here is that sustainability should not be accepted automatically. With passage of time there is likely to be a dropoff in compliance unless you have some system of vigilance or audit/feedback to keep it on track. In fact, regular audits are one of the factors they identified for successful implementation. The other “success factors” they identified were providing training and learning materials, good organizational and clinical leadership, cultivation of local champions, clarification of the role of each individual professional group, local measurement of effectiveness, and supporting local adaptation of the checklist as long as it does not become oversimplified.

The second recent paper (Johnston et al 2009) looked at compliance with the “timeout” and surgical site signing in orthopedics in Saskatoon, Saskatchewan (Canada). They actually reported two studies. The first looked at presence of the initials of the surgeon in the draped surgical field. The second study, done a year later after a surgical timeout process had been adopted, looked at both the presence of the surgeon’s initials and the completeness of the timeout in randomly selected cases. Their studies took place in several sites where the same surgeons practiced but the percentage of “emergenent” vs. “elective” cases differed. They found in the first study that the surgeon’s initials were visible in the draped field in 67% of the emeregent cases and 90% of the elective cases. In the second study, the surgeon’s initials were visible after draping in 61% of cases at the Trauma hospital (mostly emergent) vs. 83% at two “Elective” hospitals. Timeouts were conducted in 70% of cases before the incision, after the incision in 19%, and not done at all in 11%. Overall, both a timeout and surgeon’s initials were present in 70% and neither was accomplished in 7.4% of cases. The disparity in practices (by the same surgeons) between emergent and elective cases is striking and may provide some insight into why emergent surgery is one of the risk factors for wrong-site surgery.

Auditing compliance with your timeout and site identification procedures is not always easy. As the Vats group found, compliance was good when everyone knew they were being observed, then deteriorated afterward. So it is very difficult to audit compliance by sending an obvious “compliance observer” into the OR. The interesting thing about the Johnston study is that they utilized orthopedic residents as the (secret) observer and the cases were selected randomly. So using someone who is a frequent participant in the OR can be useful in the audit process. Otherwise, audio or video taping the timeout is probably the best method of auditing. We like the concept of videotaping entire cases because the videos are excellent tools in team training and process improvement. It is always interesting to hear an individual describe what he/she thought he/she said or did, then play back the video and see how what he/she said or did really came out in a different way!

The most difficult thing to audit during the timeout is the degree of attention of all the team members. We’ve done many columns on this site that have discussed the analogy between the surgical timeout and the aviation “sterile cockpit” concept, in which the undivided attention of all team members must be present during certain activities. We are often told that someone is not paying attention during the timeout and that responses are often perfunctory. Videotaping may facilitate identifying those sorts of responses.

For those who are interested, the audit tool used by the Johnston group is quite thorough and useful.

One of the lessons in the Vats paper is to allow modification of the WHO Safe Surgey checklist but don’t allow oversimplification. On the other hand, they also note that checklists that are too complicated are not good. We do have a tendency to add too many things to the checklists. But that is probably because too few OR teams make use of another very useful tool: the pre-op huddle or pre-op briefing. The latter are more informal get-togethers by all members of the surgical team before a case where needs and contingencies are raised. Some of the issues that might be discussed in a pre-op huddle are:

• Do we have all the necessary equipment? Implants? X-rays? Records?
• Consent complete and correct?
• Is a conversion to open procedure likely?
• What kind of complications might we anticipate?
• Is this a high risk case for surgical fire?
• Will it be a long surgery?
• If so, will we need to reposition patient?
• If so, will we need DVT prophylaxis?
• If so, will additional antibiotics be needed?
• If so, will breaks or change of team members occur?
• If so, will we need to ease up on traction temporarily?
• If so, how will we be reminded to do all these things?
• Will there be a surgical specimen for pathology?
• Is a second timeout going to be needed (eg. multiple procedures or multiple surgical teams)?

Our December 9, 2008 Patient Safety Tip of the Week “Huddles in Healthcare” discussed pre-op briefings. Lingard et al (Lingard 2008) used a checklist to structure short team briefings and documented both reduction in the number of communication failures and other utility of the intervention. Nundy and colleagues at Johns Hopkins (Nundy 2008) used a very simple format for pre-operative briefings that led to a 31% reduction in unexpected delays in the OR and a 19% reduction in communication breakdowns that lead to delays. The tool they used was simple and consisted of 5 key items:

• Names and roles of team players
• Correct patient/procedure/site (“timeout”)
• Prophylactic antibiotics given?
• What are the critical steps of the procedure?
• What are the potential problems in the case?

But one of the unsaid messages in the Nundy paper is the KISS (“Keep It Simple, Stupid”) principle. Anticipate things and try to discuss the most serious things that might happen, but don’t make the process so complex and long that team members lose their attention. A typical pre-op huddle or briefing ordinarily takes no more than 3-4 minutes.

So take a look at your processes and see whether you have the right mix of items in your surgical timeout and your pre-op briefing. And make sure you also read the Pennsylvania Patient Safety Authority’s Principles for Reliable Performance of Correct-Site Surgery and their other great tools for preventing wrong-site surgery if you are not familiar with them.

References:

The Joint Commission. Sentinel Event Trends Reported by Year.

http://www.jointcommission.org/NR/rdonlyres/67297896-4E16-4BB7-BF0F-5DA4A87B02F2/0/se_stats_trends_year.pdf

Pennsylvania Patient Safety Authority. Pennsylvania Patient Safety Advisory. Improvement in Preventing Wrong-Site Surgery! Traction or Transient?

Pa Patient Saf Advis 2009 Sep;6(3):104-6.

http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2009/Sep6(3)/Pages/104.aspx

Vats A, Vincent CA, Nagpal K et al. Practical challenges of introducing WHO surgical checklist: UK pilot experience. BMJ 2010;340:b5433

http://www.bmj.com/cgi/content/extract/340/jan13_2/b5433

Johnston G, Ekert L, Pally E. J. Surgical site signing and "time out": issues of compliance or complacence. The Journal of Bone and Joint Surgery (American) 2009; 91: 2577-2580

http://www.ejbjs.org/cgi/content/abstract/91/11/2577

supplementary material (checklist used in Study 2 of Johnston paper)

http://www.ejbjs.org/cgi/data/91/11/2577/DC1/1

Henrickson SE, Wadhera RK, ElBardissi AW, Wiegmann DA, Sundt TM.

Development and Pilot Evaluation of a Preoperative Briefing Protocol for Cardiovascular Surgery. Journal of the American College of Surgeons 2009; 208: 1115-1123

http://www.journalacs.org/article/PIIS1072751509001318/abstract

Nundy S, Mukherjee A, Sexton JB, Pronovost PJ,  Andrew Knight A, Rowen LC, Duncan M, Syin D, Makary MA. Impact of Preoperative Briefings on Operating Room Delays: A Preliminary Report. Arch Surg 2008; 143(11):1068-1072

http://archsurg.ama-assn.org/cgi/content/abstract/143/11/1068

Lingard L, Regehr G, Orser B, Reznick R, Baker GR, Doran D, Espin S, Bohnen J, Whyte S. Evaluation of a Preoperative Checklist and Team Briefing Among Surgeons, Nurses, and Anesthesiologists to Reduce Failures in Communication. Arch Surg, Jan 2008; 143: 12-17

http://archsurg.ama-assn.org/cgi/content/abstract/143/1/12

Pennsylvania Patient Safety Authority. Principles for Reliable Performance of Correct-Site Surgery

http://patientsafetyauthority.org/EducationalTools/PatientSafetyTools/PWSS/Documents/principles.pdf

Pennsylvania Patient Safety Authority. Tools for Preventing Wrong-Site Surgery.

http://patientsafetyauthority.org/EducationalTools/PatientSafetyTools/PWSS/Pages/home.aspx

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January 26, 2010           

Preventing Postoperative Delirium

Our October 2008 back-to-back columns “Managing Delirium” and “Preventing Delirium” talked about high cost of delirium in both human and financial terms, the risk factors and precipitating factors, methods of identifying delirium, and principles of management. Drugs are extremely common precipitating factors and use of sedating agents is one of the biggest contributors to the occurrence of delirium. Patients who develop postoperative delirium often have received a variety of drugs during surgery that may predispose to delirium (anesthetics, sedating agents, opioids, etc.). So it should be logical to investigate whether modifications in use of these agents might reduce the likelihood of postoperative delirium. And, in fact, there are a couple recent studies doing just that.

Sieber and colleagues at Johns Hopkins Bayview Medical Center this month published the results of a study testing their hypothesis that reducing the depth of sedation during surgery might reduce the incidence of postoperative delirium (Sieber et al 2010). They looked at elderly patients undergoing hip fracture repair under spinal anesthesia with propofol sedation. Patients with severe dementia (MMSE score less than 15) were excluded but those with mild to moderate dementia were included, as were those lacking obvious cognitive impairment prior to surgery. They randomized patients to receive either light or deep sedation with propofol, using the bispectral index (BIS) on EEG monitoring to assess depth of sedation. Their findings were striking. Those in the light sedation group developed postoperative delirium half as often as those in the deep sedation group (19% vs. 40%). The number needed to treat (NNT) to avoid one case of postoperative delirium was 4.7. And for those without significant cognitive impairment (MMSE score greater than 24) the NNT was 3.5. That is one of the most successful interventions in prevention of delirium.

Though the total dose of propofol was significantly higher in the deep sedation group, the total dose did not predict the occurrence of postoperative delirium. Rather, the depth of sedation appears to be the most important predictor of postoperative delirium in this patient population.

The results may not be generalizable to other populations or other agents used for sedation. As noted above, patients with pre-existing severe dementia were excluded from the study. And propofol was the only sedating agent studied. But this is certainly a starting point for further studies in those other circumstances.

The accompanying editorial by Crosby et al discusses some of the problems interpreting the results and extrapolating the results to other populations. In particular, they discuss the issue of using the BIS to distinguish between light and deep sedation. Whether the cutoffs are arbitrary, the use of the BIS in propofol titrations has been fairly well accepted in clinical anesthesiology practice. Crosby et al. raise the interesting possibility that the “delirium-susceptible” brain might develop lower BIS scores than the normal brain at any given dose of propofol. Regardless, the basic tenet is a good one, i.e. that minimizing procedural sedation where possible is a logical means of reducing the chance of postoperative delirium. Crosby et al. also stress a point we have made over and over: the preoperative evaluation (aka “medical clearance”) all too often results in ordering many unnecessary studies and overlooks some very simple things (eg. the MMSE or other bedside measure of cognitive status) that may be very helpful in predicting postoperative problems (see our March 31, 2009 Patient Safety Tip of the Week “Screening Patients for Risk of Delirium”).

A second recent paper (Radtke et al 2009) looked at potentially modifiable risk factors for early postoperative delirium, that is delirium occurring in the recovery room and on the first postoperative day. Though early postoperative delirium (often known as “emergence” delirium) is predictive of ultimate postoperative delirium, the incidence of this is considerably lower than we’d expect for ultimate postoperative delirium. Nevertheless, they identified two modifiable factors that significantly influenced the freqnency of early postoperative delirium. The first was the duration of preoperative fluid fasting. Those patients having preoperative fluid fasting for greater than 6 hours had over twice the incidence of delirium as those whose fasting was 2-6 hours prior to surgery. Dehydration has long been known to be one of the factors associated with an increased risk of delirium but this is the first study to actually demonstrate that the timeframe of fluid fasting is important. The second factor was the type of opioid used intraoperatively. Those patients who received fentanyl rather than remifentanil, an opioid  metabolized differently and having a shorter half-life, had a higher rate of early postoperative delirium. The study was an observational study, not a randomized controlled trial, did not look at total occurrence of postoperative delirum, and was not restricted to elderly patients. However, the findings lay the foundation for randomized controlled trials of those two strategies to reduce the occurrence of postoperative delirium.

There were also some recent articles on the assessment and management of delirium. A study done in Germany (Leutz et al 2010) compared several delirium assessment tools commonly used in the ICU setting in a population of postoperative patients in a surgical ICU. They concluded that the Confusion Assessment Method for the ICU (CAM-ICU) and the Nursing Delirium Screening Scale (Nu-DESC) tools had comparable sensitivities in this population, identifying 81% and 83% respectively of cases meeting DSM-IV criteria for delirium. However, the specificity of CAM-ICU was considerably higher than the Nu-DESC (95% vs. 81%). Both tests performed better than the Delirium Detection Score (DSS) tool. They conclude that the CAM-ICU is the best tool in this population but that the Nu-DESC is an acceptable alternative and the DSS should not be used. Interstingly, the accompanying editorial (Young 2010) raises the interesting concept of whether tools having lower specificities might actually be better because they may detect cases of subsyndromal delirium better.

The Luetz paper includes a nice algorithm for delirium screening in the ICU. They recommend screening each ICU patient every 8 hours. If a patient is scored delirium-positive, symptom-oriented therapy is begun. The algorithm includes good advice on what to do when the RASS score indicates the patient is either oversedated or agitated or when confounders such as language barriers are present.

Also published this month are some of the first randomized controlled trials on pharmacologic management of delirium. Despite a paucity of evidence of either their efficacy or safety, haloperidol or some of the newer atypical antipsychotics are often used in management of delirium and consensus guidelines for managing delirium (Jacobi et al 2002) even include such as a recommendation despite the lack of a solid evidence base.

The MIND (Modifying the Incidence of Delirium) trial (Girard et al 2010) was a multicenter controlled trial in ICU patients with delirium randomized to 3 treatment arms (haloperidol, ziprasidone, or placebo). The study failed to demonstrate any difference in primary or secondary endpoints among the three groups. Safety profiles were similar in all three groups except that akathisia was more frequent in the haloperidol group. However, the stated primary goal of MIND was to demonstrate the feasibility of randomized controlled trials of pharmacologic agents in ICU patients with delirium and the study was really underpowered to statistically demonstrate differences between treatment groups. The mere fact that the study was done (though they had significant problems recruiting participants) shows that such trials are feasible and would need to be done on a much larger scale.

A second study (Devlin et al 2010) was a randomized controlled trial of an escalating dose of the atypical antipsychotic agent quetiapine vs. placebo in ICU patients with delirium who were allowed to be treated with “rescue” haloperidol for persistent symptoms. The quetiapine group demonstrated a shorter time to first resolution of delirium, fewer hours of delirium, and fewer hours of agitation. However, there were no significant differences in outcomes such as duration of mechanical ventilation, length of ICU or total hospital stay, or mortality. More patients in the quetiapine group were discharged to home or a rehab facility rather than a chronic care facility. Note that the small sample size (36 total patients) meant the study was not powered to show differences in outcomes other than the primary outcome. Importantly, the safety profile of quetiapine was reasonable in this population. Though it caused more sedation than placebo, the incidence of serious side effects did not differ from the placebo group and no episodes of extrapyramidal symptoms were seen. The study highlights many of the challenges in doing a study of this nature. Though this was a multicenter study, they had considerable difficulty recruiting patients for participation. In addition, the lack of a consensus standard definition of resolution of delirium was problematic. Thus, they chose the time until the first assessment using the Intensive Care Delirium Screening Checklist (ICDSC) score was equal to or less than 4. The authors suggest that their study be considered a “pilot” study and that further larger trials be undertaken to determine the effect of this approach on some of the more relevant outcome measures like mortality, ICU and total hospital LOS, cognitive function, ultimate disposition, and safety. But this is certainly a step in the right direction and shows that studies of this sort may be done, albeit with considerable logistical difficulty.

So for the time being, we can’t make any good evidence-based recommendations regarding pharmacologic management of delirium. Prevention remains our best way to manage delirium. Our best approach is still to identify patients at risk for development of delirium and take steps to avoid factors that may precipitate delirium.

Our other Patient Safety Tips of the Week on the topic of delirium:

  October 14, 2008 “Managing Delirium”

  October 21, 2008 “Preventing Delirium”

  February 10, 2009 “Sedation in the ICU: The Dexmedetomidine Study”

  March 31, 2009 “Screening Patients for Risk of Delirium”

References:

Sieber FE, Zakriya, KJ, Gottschalk A et al. Sedation Depth During Spinal Anesthesia and the Development of Postoperative Delirium in Elderly Patients Undergoing Hip Fracture Repair. Mayo Clin Proc. 2010; 85(1): 18-26

http://www.mayoclinicproceedings.com/content/85/1/18.abstract

Crosby G, Culley DJ, Marcantonio ER. Delirium: A Cognitive Cost of the Comfort of Procedural Sedation in Elderly Patients? Mayo Clin Proc. 2010; 85(1): 12-14

http://www.mayoclinicproceedings.com/content/85/1/12.full

Radtke, Finn M *; Franck, Martin *; MacGuill, Martin; Seeling, Matthes; Lutz, Alawi; Westhoff, Sarah; Neumann, Ulf; Wernecke, Klaus D; Spies, Claudia D. Duration of fluid fasting and choice of analgesic are modifiable factors for early postoperative delirium.

European Journal of Anaesthesiology 2009; 26: 000–000

http://journals.lww.com/ejanaesthesiology/Abstract/publishahead/Duration_of_fluid_fasting_and_choice_of_analgesic.99780.aspx

Luetz, Alawi; Heymann, Anja; Radtke, Finn M.; Chenitir, Chokri; Neuhaus, Ulrike; Nachtigall, Irit; von Dossow, Vera; Marz, Susanne; Eggers, Verena; Heinz, Andreas; Wernecke, Klaus D.; Spies, Claudia D. Different assessment tools for intensive care unit delirium: Which score to use? Critical Care Medicine 2010; 38(2): 409-418

http://journals.lww.com/ccmjournal/Abstract/2010/02000/Different_assessment_tools_for_intensive_care_unit.8.aspx

Young CC,  Flanagan EM. Delirium: The struggle to vanquish an ancient foe. Critical Care Medicine 2010; 38(2): 693-694

http://journals.lww.com/ccmjournal/Citation/2010/02000/Delirium__The_struggle_to_vanquish_an_ancient_foe.49.aspx

Jacobi J, Fraser GL, Coursin DB et al. Clinical practice guidelines for the sustained use

of sedatives and analgesics in the critically ill adult. Crit Care Med 2002; 30:119–141

http://journals.lww.com/ccmjournal/Citation/2002/01000/Clinical_practice_guidelines_for_the_sustained_use.20.aspx

Girard, Timothy D.; Pandharipande, Pratik P.; Carson, Shannon S.; Schmidt, Gregory A.; Wright, Patrick E.; Canonico, Angelo E.; Pun, Brenda T.; Thompson, Jennifer L.; Shintani, Ayumi K.; Meltzer, Herbert Y.; Bernard, Gordon R.; Dittus, Robert S.; Ely, E Wesley; for the MIND Trial Investigators. Feasibility, efficacy, and safety of antipsychotics for intensive care unit delirium: The MIND randomized, placebo-controlled trial. Critical Care Medicine 2010; 38(2): 428-437

http://journals.lww.com/ccmjournal/Abstract/2010/02000/Feasibility,_efficacy,_and_safety_of.10.aspx

Devlin, John W.; Roberts, Russel J.; Fong, Jeffrey J.; Skrobik, Yoanna; Riker, Richard R.; Hill, Nicholas S.; Robbins, Tracey; Garpestad, Erik. Efficacy and safety of quetiapine in critically ill patients with delirium: A prospective, multicenter, randomized, double-blind, placebo-controlled pilot study. Critical Care Medicine 2010; 38(2): 419-427

http://journals.lww.com/ccmjournal/Abstract/2010/02000/Efficacy_and_safety_of_quetiapine_in_critically.9.aspx

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February 2, 2010           

The Hazards of Radiation

In our October 20, 2009 Patient Safety Tip of the Week “Radiology Again…But This Time It’s Really Radiology!” we discussed the FDA safety alert that had been issued after a large number of radiation overdoses occurring at Cedars-Sinai from CT brain perfusion imaging studies. Ultimately, the FDA found 250 such cases at Cedars-Sinai and also found similar cases at multiple other hospitals and in multiple states (AuntMinnie.com Dec.7, 2009). More than one type of CT scanner was also involved. Victims of the radiation overdoses suffered primarily hair loss and cutaneous damage but the potential long term effects remain speculative. The occurrence was a wakeup call for hospitals and diagnostic facilities to put in place more rigorous safeguards in developing imaging protocols and better monitoring of radiation dosages actually administered.

As alarming as the CT incidents were, they pale in comparison to some of the incidents due to radiation therapy that were revealed last week in a 2-part series in the New York Times. Walt Bogdanich and colleagues (Bogdanich 2010a and 2010b) did an amazing job researching this revealing series, going far beyond what most investigative and regulatory bodies could have done.

Though both ASTRO (American Society for Radiation Oncology) and AAPM (American Association of Physicists in Medicine) were quick to issue statements pointing out the relative rarity of serious errors in radiation therapy and the unquestioned significant benefits that patients may get from radiation therapy, they missed some of the key messages in the NYT series.

The NYT series begins with some very graphic and sad descriptions of suffering and death related to radiation therapy overdoses resulting from errors. That, of course, is a technique we strongly recommend in patient safety (see our December 2009 What’s New in the Patient Safety World column “Stories, Not Statistics”). But those are just to get your attention. The real gist of the series is that radiation therapy errors are probably considerably more common than we are led to believe and that the remarkably fast pace of advances in radiation oncology are outstripping our ability to implement adequate safeguards. Hospitals and outpatient facilities, in their haste to get the latest and greatest technology, often underestimate and underresource all the other things needed for a safe implementation. Ensuring that all relevant staff are adequately trained and understand the new technology often takes a back seat to marketing the new technology and getting it started.

Striking in the NYT series is the delay that often occurs before facilities recognize that an error has occurred and that multiple patients may be affected before corrective action is taken. Since the effects of radiation damage may be delayed, it is not surprising that such lapses in recognition may occur. More importantly, they noted that many facilities have no outcome monitoring in place – neither measuring their successes nor their complications! The NYT authors interviewed an impressive array of radiation therapy experts in putting together this series. Failure rates with some of the newer technologies are often striking. One interviewee noted that among hospitals seeking participation in a clinical trial, 30% failed to accurately radiate a phantom object. They pointed out that a variety of relatively inexpensive independent evaluators of radiation therapy programs are seldom used.

Grossly understated in the NYT series is the economic incentives driving much of the boom in advanced radiation oncology procedures and techniques. The NYT series does acknowledge that some hospitals and facilities, in attempt to capture part of the oncology market, have implemented technologies like IMRT with inadequate training of all relevant staff and software having many glitches. Frankly, the reimbursement and profitability for IMRT outstrips more conventional external beam radiation therapy many times over. Financial motives clearly are one of the root causes of this problem.

Ironically, the Pennsylvania Patient Safety Authority had done a nice article on Errors in Radiation Therapy in September 2009. While pointing out that such errors are rare, the PPSA acknowledged that devastating and fatal injuries may result from errors in radiation therapy. They describe radiation therapy as a complex and high risk procedure involving a large number of steps and medical staff. Any process or procedure with so many steps and personnel involved inevitably is associated with errors that may lead to poor outcomes. Not only may such errors result in radiation damage to tissue but others may result in undertreatment of cancer or other condition being treated.

Over a period of about four and a half years, the PPSA received only 25 reports of radiation oncology events. Most were near misses and only 6 involved serious injury. Leading categories of event were a patient receiving the wrong dose of radiation (40%), wrong patient (16%), wrong location radiated (12%), wrong side (12%) and wrong setup (8%). They also report similar problems reported to the Pennsylvania Department of Environmental Protection and a voluntary web-based database of radiation therapy events maintained by the Radiation Oncology Safety Information System.

The real value of the PPSA article is in the risk reduction strategies recommended. Given that patient identification and laterality issues comprised a significant portion of the events in their database, it is no surprise they recommend focus on patient identification. The point out that Joint Commission excludes radiation oncology from the Universal Protocol standard. However, they recommend that radiation therapy staff perform a final verification, including 2-identifier verification of patient identity, site of treatment, laterality (including comparison to films and images), and comparison to the consent and treatment plan.

They also recommend checking the radiation therapy treatment plan and performing an independent recheck before the patient receives the prescribed dose of radiation. They point to an Australian study (Duggan et al 1997) that showed independent double checks resulted in changes to treatment plans in about 10% of cases, though a substantial increase in staffing is required to carry these out.

They have an excellent discussion on the use of computer technology for treatment plans and discuss the computerized record and verification (RV) system that most linear accelerators have. They acknowledge that, though RV systems have significantly reduced the number of errors in radiation therapy, they have introduced new types of errors and many facilities and staff have become overreliant on the computer systems. Moreover, human errors during manual entry into RV systems may be propogated to multiple patients. They also acknowledge that errors in computer programs are generally much more difficult to detect than those in manual systems.

They also recommend in vivo densitometry as a reliable method for verification of external beam therapy. This refers to dose measurements taken on patients during the delivery of radiation therapy.

The PPSA article attributes the rarity of errors in radiation therapy to the “strict regulatory environment”, stating that it is considered to be one of the most highly regulated medical practices. The NYT series certainly blows holes in that perception! The NYT authors noted numerous examples of significant incidents avoiding oversight because of split regulatory authority, such that neither agency had oversight capability and numerous other deficiencies in regulatory oversight. The bottom line: even though the published rates for radiation therapy errors are on the order of 1 in 1000 cases, no one really knows what the real error rate is.

Despite the alarming nature of this week’s column, we also do have some positive news as well. In our October 20, 2009 Patient Safety Tip of the Week “Radiology Again…But This Time It’s Really Radiology!” we made a case that facilities should attempt to track cumulative doses of radiation (particularly for radiation in diagnostic imaging). In fact, one such healthcare system has begun to do exactly that (AuntMinnie.com January 28, 2010). The Lifespan Health Network in Rhode Island has added software that keeps track of previous CT scans done at any of its member hospitals. If a physician then orders a new CT scan the software looks at the prior cumulative radiation dose and, if appropriate, may warn the ordering physician that the patient has already received a relatively high radiation dosage in the past. This may result in the physician considering alternative imaging techniques that may not use radiation. Ultimately as health systems develop longitudinal electronic medical records or RHIO’s accumulate medical records from multiple sources and patients have their own electronic personal health records, we expect that such software algorithms would track cumulative radiation doses much more accurately.

References:

FDA finds new cases of CT radiation overexposure
By Brian Casey
AuntMinnie.com staff writer
December 7, 2009

http://www.auntminnie.com/index.asp?Sec=sup&Sub=cto&Pag=dis&ItemId=88721

Bogdanich W. The Radiation Boom. Radiation Offers New Cures, and Ways to Do Harm. New York Times. January 24, 2010

http://www.nytimes.com/2010/01/24/health/24radiation.html

Bogdanich W. The Radiation Boom. As Technology Surges, Radiation Safeguards Lag.

The New York Times. January 26, 2010

http://www.nytimes.com/2010/01/27/us/27radiation.html

Williams TR. Radiation therapy 99.99 percent safe and effective (ASTRO Letter to NY Times). January 25, 2010

http://cs.astro.org/blogs/astronews/pages/web-exclusive-letter-to-the-new-york-times-january-25-2010.aspx

AAPM. AAPM Statement on Quality Radiation Therapy. January 2010

http://www.aapm.org/publicgeneral/QualityRadiationTherapy.asp

Pennsylvania Patient Safety Authority. Errors in Radiation Therapy

Pa Patient Saf Advis 2009 Sep;6(3):87-92.  http://www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2009/Sep6(3)/Pages/87.aspx

Duggan L, Kron T, Howlett S, et al. An independent check of treatment plan, prescription and dose calculation as a QA procedure.
Radiother Oncol 1997; 42(3): 297-301

http://www.ncbi.nlm.nih.gov/pubmed/9155082?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=47

Ridley EL. Software offers alerts for patients with past CT scans.
AuntMinnie.com January 28, 2010

http://www.auntminnie.com/index.asp?Sec=sup&Sub=ris&Pag=dis&ItemId=89255

Print “The Hazards of Radiation”

February 9, 2010 

More on Preventing

Inpatient Suicides

In the year that has gone by since our January 6, 2009 Patient Safety Tip of the Week “Preventing Inpatient Suicides” there have been several very informative articles pertaining to inpatient suicides. Keep in mind that suicides may occur in general hospitals as well as psychiatric hospitals so you need to be cognizant of the risks regardless of what type of facility you have.

An excellent review of inpatient suicides (Tishler 2009) emphasized that individual risk assessment is critical and that one of the biggest mistakes made is that decisions about managing suicide risk are often made based upon staffing levels rather than the individual patient’s risk assessment. In fact, Tishler et al caution against relying too heavily on risk factors or predictors taken from previous studies because those often don’t provide a good assessment of current risk. Rather they make the case for determining the presence of warning signs or immediate “red flags”. They make the distinction between chronic and acute risk factors, the latter tending to be more predictive of suicide and including symptoms such as severe anxiety, agitation, and severe anhedonia.

A study from Taiwan (Cheng et al 2009) compared psychiatric inpatients to “nonpsychiatric” inpatients who attempted or completed suicide in general hospitals and found some very important differences. Patients who attempted or committed suicide in general hospitals were older, more likely male, had more chronic physical conditions, and were more likely to attempt suicide in the first week of admission and use more violent means than those patients who were admitted to psychiatric units. They were also more likely to attempt suicide at night or while absent without leave and less likely to have communicated suicidal intent. Delirium and substance abuse were also more common in nonpsychiatric patients who committed suicide. Tishler et al (Tishler 2009) also noted that patients with delirium or dementia that is associated with agitation or impulsivity are at increased risk for suicide. Like the Cheng study, Tishler et al also noted that patients who attempt or commit suicide on general hospital units are more likely to be male and older, have agitation or delirium, have pain or other physical distress related to their medical or surgical condition, and often have factors such as poor family relationships, divorce, unemployment, bereavement, or a poor prognosis for longevity.

And when we are talking about “nonpsychiatric” patients above, we are not talking about the overdose patient who is temporarily admitted to an ICU until medically stable enough to be transferred to an inpatient psychiatry unit. Those patients usually get sufficient attention to suicide risk and close observation. Rather, we are talking about patients admitted to a med/surg unit with primarily a medical problem who go on to attempt or commit suicide, usually to everyone’s surprise. We don’t do a very good job of assessing suicide risk in the medical/surgical patient nor have we really come across any good tools for assessing that risk. Note that in some cases we may even enable it. We’ve talked before about the value of moving the delirious patient to a room that has more natural daylight. Well, some of these rooms also have windows from which someone can jump! So the choice of rooms needs to consider whether the windows can be opened from the inside or whether there are protective screens. Also keep in mind that patients on med/surg floors are more likely to have access to things like plastic trash can liners and cleaning materials (see below) that can also be used for suicide attempts. And whereas we may do a good job of removing suicide hazards from the environment on a psychiatric inpatient unit, the patient on the med/surg unit has access to sharps, tubing, loopable items and more easy egress for elopement (Bostwick et al 2009).

And one other good caveat: when we put a patient on 1:1 observation, whether for suicidal risk or because of delirium, we also need to remember it is not practical for any one individual to remain continuously vigilant for long periods of time nor should they be engaged in other activities. Tishler et al (Tishler 2009) recommend changing the observation person every two hours to avoid burnout.

Elopement/absconding is an issue that appears in many articles on inpatient suicide. That is these are inpatients who abscond/elope from the unit (either psychiatric unit or med/surg unit) and then commit suicide. A large study done in the UK (Hunt et al 2010) notes that such patients tend to be young, unemployed, and homeless with high rates of schizophrenia, previous violence, and substance abuse. They were also more likely to be involuntarily admitted to psychiatric units and likely to be noncompliant with treatment.

One of the more comprehensive studies on suicide focused on avoidable deaths (University of Manchester 2006). They confirmed that absconding from inpatient wards was a significant risk factor, particularly in the first 7 days. They note that wards can reduce absconding by:

• understanding the factors that trigger it, such as a disturbed ward environment or an incident affecting the patient

• making greater use of technology, such as CCTV or swipe cards, to observe and control ward entry and exit

The time immediately following discharge from an acute inpatient service is also a vulnerable period. 22% of the suicides in the Manchester study occurred between discharge and first followup appointment in community. They recommend regular assessment of risk during the period of discharge planning (or temporary leave) include:

• addressing stressors that will be encountered on leave and on discharge
• the patient having ways of contacting services if a crisis occurs during leave or after discharge
• early follow-up on discharge, including telephone calls immediately after discharge for high risk patients and face-to-face contact within a week of discharge
• support arrangements for people who discharge themselves from wards

The Manchester study was quite informative. Despite a substantial number of deaths, in only 28% of in-patient suicides did clinicians retrospectively view these deaths as preventable yet all such deaths should be regarded as potentially preventable. 22% of the in-patient deaths occurred in people who were (or were supposed to be) under observation, with 3% said to be under one-to-one observation. Two conclusions are clear from this. Firstly, intermittent observation regimens provide long gaps in observation and they are unsuitable for the care of high risk patients unless additional measures are taken, such as the observation of ward exits. Secondly, close observation must be strictly carried out. There should be no gaps in one-to-one observation and if a patient is to be observed every ten minutes, this time gap must be carefully adhered to. They also stressed that clinical staff need be diligent in removing non-collapsible curtain rails and eliminate other ligature (loopable) points, or at least make them inaccessible, with particular attention to hooks and handles on windows and doors. They also stressed risk factors for suicide, noting that those patients with dual diagnoses were especially at risk and that there are different antecedents of suicide in older patients.

Some lessons from our previous column “Preventing Inpatient Suicides” are also worth repeating. While suicide risk assessments are usually done on admission (though sometimes incomplete due to the patient’s inability or unwillingness to participate), the Joint Commission Sentinel Event Alert on suicides noted that reassessments are not well done.

We noted cases where patients have attempted suicide after locking themselves in the bathroom of the radiology suite (or other area in the hospital aside from the behavioral health units). We recommended use of a “Ticket to Ride” type communication tool for such hospital transports including special warnings and considerations for potentially suicidal patients so that all staff at the “receiving” end understand their responsibilities.

Also, the “sitters” commonly utilized to monitor the potentially suicidal patient on the non-psychiatric unit are often not specifically trained in assessment of the environment or management of the suicidal patient.

And standardized order sets for various behavioral health conditions, whether paper-based or computer-based, are now being developed and implemented in a more widespread manner. With use of computer order entry and clinical decision support tools, alerts and reminders (eg. to do a suicide reassessment) might be used to improve care.

There are also some good tools available that can help reduce the likelihood of patients committing suicide as inpatients. In our January 6, 2009 Patient Safety Tip of the Week “Preventing Inpatient Suicides” we noted that the VA has developed a mental health environment-of-care checklist that is available by e-mail request. Actually that checklist is now available online on the VA Patient safety website and there is a new article on use of that checklist in this month’s Joint Commission Journal on Quality and Patient Safety (Mills 2010). They implemented the checklist at 113 VA facilities and identified over 7000 potential hazards. A real value of the checklist is that it not only itemizes hazards but it is actually weighted by potential severity of the risk of each hazard (on a scale of 1 to 5). The commonest hazards they identified were anchor points that could be used for hanging. The second most common hazards were materials that could be used as a weapon against staff or other patients. Third most common were security issues that raised the risk for elopement. They also looked at the location of hazards and noted that bathrooms and bedrooms were a frequent site for hazards. Those two rooms obviously are potentially at greater risk for suicide because of patient isolation. Their discussion of the elopement risk is also quite good. They note certain areas (eg. physical therapy rooms, art rooms, group rooms, utility rooms, etc.) where it is important to identify that patients will not be left unsupervised and they discuss safeguards such as self-closing and locking doors. Though they discuss the use of video camera monitoring, they point out that it is unreasonable to expect staff to reliably monitor video screens for long periods of time. They also point out that, though they found materials for suffocation or poisoning less often, the high potential for lethality of those materials merits special attention. This would include items like plastic liners in trash cans and cleaning products. Those are especially important to look for on units other than psychiatric units. Overall, this is a very good checklist for conducting environmental rounds with a purpose of reducing potential risk for suicides.

The National Patient Safety Agency (NPSA) in the UK also has a toolkit on preventing suicide for mental health services. This includes the toolkit itself, a ward manager checklist and an audit tool. These tools address not only the environmental risks similar to the VA tool but also look at your systems for evaluation of patient suicide risk assessment, layout of your unit, observation policies, treatment plans, post-discharge plans and follow-ups, medication and compliance issues, and staff training and retraining. And don’t forget that you need to educate and train any agency staff that may be working temporarily on your units. And teaching family members or significant others what signs of symptoms to watch for is also very important. Very comprehensive tools.

Suicide on one of your inpatient services, whether psychiatric or med/surg, is a devastating event for families, your other patients, your staff, your community, and your reputation. You need to get a better understanding of your vulnerabilities and take action to mitigate the risks of potentially avoidable events.

References:

Tishler CL, Reiss NS. Inpatient suicide: preventing a common sentinel event. General Hospital Psychiatry 2009; 31: 103-109

http://www.ncbi.nlm.nih.gov/pubmed/19269529?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=11

Cheng I-C, Hu F-C, Tseng M-C M. Inpatient suicide in a general hospital
General Hospital Psychiatry 2009; 31: 110-115

http://www.ncbi.nlm.nih.gov/pubmed/19269530?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=3

Bostwick JM, Lineberry TW. Editorial on “Inpatient suicide: preventing a common sentinel event”. General Hospital Psychiatry 2009; 31: 101-102

http://www.ncbi.nlm.nih.gov/pubmed/19269528?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=5

Hunt IM, Windfuhr K, Swinson N, et al. and the National Confidential Inquiry into Suicide and Homicide by People with Mental Illness. Suicide amongst psychiatric in-patients who abscond from the ward: a national clinical survey. BMC Psychiatry 2010; 10: 14

http://www.biomedcentral.com/content/pdf/1471-244x-10-14.pdf

University of Manchester. Five Year Report of the National Confidential Inquiry Into Suicide and Homicide By People With Mental Illness. Avoidable Deaths. December 2006

http://www.medicine.manchester.ac.uk/psychiatry/research/suicide/prevention/nci/reports/avoidabledeathsfullreport.pdf

Mental Health Environment of Care Checklist

http://www.patientsafety.gov/SafetyTopics/MHEOCC.xls

Mills PD, Watts BV, Miller S, Kemp J, Knox K. DeRosier JM, Bagian JP.

A Checklist to Identify Inpatient Suicide Hazards in Veterans Affairs Hospitals
Joint Commission Journal on Quality and Patient Safety. Volume 36, Number 2, February 2010 pp. 87-93(7)
http://www.ingentaconnect.com/content/jcaho/jcjqs/2010/00000036/00000002/art00006

NPSA (UK). Preventing suicide: a toolkit for mental health services

http://www.nrls.npsa.nhs.uk/resources/?entryid45=65297

toolkit itself

http://www.nrls.npsa.nhs.uk/EasySiteWeb/getresource.axd?AssetID=65293&type=full&servicetype=Attachment

audit tool

http://www.nrls.npsa.nhs.uk/EasySiteWeb/getresource.axd?AssetID=65295&type=full&servicetype=Attachment

ward manager checklist

http://www.nrls.npsa.nhs.uk/EasySiteWeb/getresource.axd?AssetID=65296&type=full&servicetype=Attachment

Print “More on Preventing Inpatient Suicides”

February 16, 2010 

Spin/Hype........

Knowing It When You See It

In many of our columns we have criticized published studies for presenting their results in a biased fashion. Understanding how to read articles published in peer-reviewed journals is more important than ever since even in the most respected journals articles are published with conclusions and discussions claiming outcomes not truly supported by the data.

An excellent review on the limitations of randomized controlled trials (RCT’s) was recently published in Journal of the American College of Cardiology (Kaul and Diamond 2010). This paper is very good at helping you understand some complicated statistical issues but really emphasizes three points we have often made in the past:

• Many articles report outcomes that are statistically significant but are of little clinical significance.
• Post-hoc subgroup analyses are prone to error and inappropriate interpretation and should be used only to generate ideas for futures studies. Otherwise, they may erroneously lead to adoption of practices that are not evidence-based.
• Use of composite outcomes is especially likely to give rise to inappropriate conclusions when the outcomes are driven by one component of that composite, especially when that component is not as clinically significant as other components.

They provide numerous examples from the cardiology literature demonstrating the above concepts. Whether or not you are interested in cardiology studies, the paper is worth reading just to help you better understand how to read a research article and identify biases that may render the conclusions erroneous.

When we teach medical students or residents or even our attending physician colleagues at Journal Club how to read and interpret the literature there are some articles that serve as good examples of such biases. One was a study on the use of dexmedetomidine in the ICU (see our February 10, 2009 Patient Safety Tip of the Week “Sedation in the ICU: The Dexmedetomidine Study”). That study was a good example of a study that was presented in a positive light even though the study failed to meet its primary outcome goals. It was also a good example of the failure to use clinically important outcomes as primary measures. And we discussed then the likelihood that dexmedetomidine would start to become adopted in ICU’s without a solid evidence base and that is exactly what were are beginning to see. Marketing trumps science most of the time!

By the way, we hope you also saw the article in the New York Times this past weekend demonstrating the same phemonenon with robotic surgery for prostate cancer (Kolata 2010).

And then there are some studies that are like “the gift that keeps on giving” – the study spawns multiple articles that all tend to “spin” the conclusions in a certain direction and create a “hype” about a new drug or new technology. A great example we like to use is a series of articles on the use of silver-coated endotracheal tubes for the prevention of ventilator-associated pneumonia.

In our September 2, 2008 Patient Safety Tip of the Week “Updates on VAP Prevention” we discussed an article on use of silver-coated endotracheal tubes to prevent VAP that appeared in the August 20, 2008 issue of JAMA (Kollef et al 2008). That article showed the silver-coated endotracheal tubes led to a relative risk reduction for VAP of 36% in patients who were intubated for at least 24 hurs. Certainly sounds impressive! However, closer scrutiny of the article raises numerous questions. The rationale for using silver-coated endotracheal tubes makes good sense from a biological standpoint. The diagnosis of VAP was based on quantitative culture of bronchoalveolar fluid if VAP was suspected on the basis of radiographic findings or other clinical signs including fever or hypothermia, leukocytosis or leukopenia, or purulent tracheal aspirate. However, when one looks at the data, the absolute risk reduction for VAP was only 2.7% and the NNT (number needed to treat) to prevent one case of VAP was 37. More importantly, the silver-coated endotracheal tube group showed no improvement in mortality, duration of intubation, or ICU or total LOS. Data on antibiotic use or costs was not provided.

Other issues with the study were lack of standardization of other interventions (in both the control and silver arms), single blinding (the investigators were not blinded), relatively low rates of VAP in both the silver and control groups, a disproportionate percentage of patients with COPD in the control group, a low percentage of patients able to provide informed consent, and industry funding for the study. Note also that the “supplemental” information referred to in the article (having to do with criteria for diagnosis of VAP) is not downloadable from the website address provided in the article. And a subsequent critical letter to the editor (Klompas 2008) even noted that much of the microbiological flora identified in the article may well have represented contaminants rather than truly pathological species.

The bottom line is that we were left with an intervention that requires a large NNT and fails to improve any of the really important clinical outcomes. So they broke Rule #1 “Make sure that results are not just statistically significant. Make them clinically important.”

But the spin does not stop there. A few months later another paper from the NASCENT trial (Shorr et al 2009) touts the cost effectiveness of the silver-coated endotracheal tubes. They use the data on percent of cases of VAP avoided with the silver-coated endotracheal tubes from the above NASCENT study but use the marginal cost savings for VAP cases avoided from the published literature. They fail to state that in the NASCENT study, in fact, the silver-coated endotracheal tube group showed no improvement in mortality, duration of intubation, or ICU or total LOS. Though it did not provide data on actual costs in the NASCENT study, it is hard to believe there were any cost savings given the lack of improvement in those clinically important outcomes. Yet the new paper leads you to believe that use of the silver-coated endotracheal tubes is a “slam dunk” and can save you as much as $16,000 per case of VAP prevented.

Not had enough yet? There’s more. A new paper (Afessa et al 2009) does a post-hoc cohort analysis on the NASCENT trial data and separates them out into cohorts that did develop VAP and those that did not. They then conclude that for those that did develop VAP the mortality rates were statistically significantly lower in the silver-coated group. They go on to discuss all the potential biological reasons why the silver-coated tubes might lower mortality in these patients with VAP. To be fair, the authors do include a statement that because this is a post-hoc analysis, the findings are exploratory and need to be confirmed in further studies. However, they give only 3 lines to the fact that in those patients who did not develop VAP (a much larger group) mortality was statistically significantly increased in the silver-coated group! So if post-hoc analysis is being allowed why wasn’t the title of this paper “Association Between a Silver-Coated Endotracheal Tube and Increased Mortality in Patients Who Don’t Develop Ventilator-Associated Pneumonia”? Of course, because this is a post-hoc subgroup analysis, neither conclusion should be made. The point is that post-hoc analyses can be used to drive practice patterns that are not truly evidence-based.

But the overarching theme is this: those who read the three papers without having their antennae up for spin and hype would think that a randomized controlled trial by respected investigators with results published in three prestigious peer-reviewed medical journals showed that silver-coated endotracheal tubes prevent VAP, save lots of money, and reduce mortality. When in fact that has not yet been demonstrated. And if the FDA approves these endotracheal tubes (which it may, depending on what route is chosen for review of a modification of devices that are already in use) you can bet many will rush out and purchase these new silver-coated endotracheal tubes.

Most bothersome is the fact that our leading medical journals allow papers to be written in such a fashion that “spins” results in ways that promote devices or treatments in ways well beyond what the science actually showed.

References:

Kaul S, Diamond GA. Trial and Error: How to Avoid Commonly Encountered Limitations of Published Clinical Trials. J Am Coll Cardiol 2010 55: 415-427

http://content.onlinejacc.org/cgi/content/abstract/55/5/415

Kolata G. Results Unproven, Robotic Surgery Wins Converts.

New York Times February 13, 2010

http://www.nytimes.com/2010/02/14/health/14robot.html?scp=1&sq=robot&st=cse

Kollef MH. Afessa B. Anzueto A. Veremakis C. Kerr KM. Margolis BD. Craven DE. Roberts PR. Arroliga AC. Hubmayr RD. Restrepo MI. Auger WR. Schinner R. NASCENT Investigation Group. Silver-coated endotracheal tubes and incidence of ventilator-associated pneumonia: the NASCENT randomized trial. JAMA 2008; 300(7):805-13

http://jama.ama-assn.org/cgi/content/abstract/300/7/805

http://jama.ama-assn.org/cgi/reprint/300/7/805

Chastre, Jean MD. Preventing Ventilator-Associated Pneumonia: Could Silver-Coated Endotracheal Tubes Be the Answer?. JAMA 2008; 300(7):842-844

http://jama.ama-assn.org/cgi/content/extract/300/7/842

Klompas M. Silver-Coated Endotracheal Tubes and Patient Outcomes in Ventilator-Associated Pneumonia. JAMA. 2008; 300(22): 2605

http://jama.ama-assn.org/cgi/content/extract/300/22/2605

Kollef MH, Afessa B, Anzueto A. Silver-Coated Endotracheal Tubes and Patient Outcomes in Ventilator-Associated Pneumonia—Reply. JAMA 2008; 300(22): 2605-2606

http://jama.ama-assn.org/cgi/content/extract/300/22/2605-a

Afessa B, Shorr AF, Anzueto AR, Craven DE, Schinner R, Kollef MH.

Association Between a Silver-Coated Endotracheal Tube and Reduced Mortality in Patients With Ventilator-Associated Pneumonia. Chest 2009; prepublished online December 28, 2009

http://chestjournal.chestpubs.org/content/early/2009/12/24/chest.09-0391.abstract

Shorr AF, Zilberberg MD, Kollef M. Cost-effectiveness analysis of a silver-coated endotracheal tube to reduce the incidence of ventilator-associated pneumonia. Infect Control Hosp Epidemiol. 2009 Aug; 30(8):759-763

http://www.journals.uchicago.edu/doi/abs/10.1086/599005

Prior columns on VAP:

September 2, 2008 Patient Safety Tip of the Week “Updates on VAP Prevention”

November 11, 2008 Patient Safety Tip of the Week “Probiotics and VAP Prevention”

January 2009 What’s New in the Patient Safety World “Preventing Infections in the ICU”

Print “Spin/Hype…Knowing It When You See It”

February 23, 2010 

Alarm Issues in the News Again

It’s been almost three years since we did our first series on patient safety issues related to alarms (see our Patient Safety Tips of the Week for March 5, 2007 “Disabled Alarms”, March 26, 2007 “Alarms Should Point to the Problem”, and April 2, 2007 “More Alarm Issues”). Since the early 1990’s we’ve always put alarms at the top of our list of items to check when doing patient safety walk rounds. And we encourage nurses, physicians, and quality improvement personnel to conduct alarm rounds periodically. And problems with alarms are one of our “Big 3” factors encountered most often in our root cause analyses. We even play a little game with hospital CEO’s, betting them $50 we can find in their hospital within 2 hours at least 5 alarms that have either been disabled or whose volumes have been reduced to barely audible levels or whose parameters have been set such that they will allow clinically significant deterioration to go unheeded. Then we head straight to the ICU’s, ER and dialysis unit to easily find our 5 alarms. (We never actually make them pay off the bet but they sure get embarrassed when we find them!)

This month a fatality related to a cardiac alarm inadvertently left off at the Massachusetts General Hospital made the news (Kowalczyk 2010). The Globe article speculates that the alarm may have been turned off by someone during a previous patient event, thinking they were “pausing” the alarm rather than turning it off. Few other details are provided but the Globe article quotes Joint Commission personnel stating that they have been seeing increased reports of alarm-related incidents. The Mass General’s actions have included inspecting all alarms in their system, ensuring that the “off” switch cannot be used, assigning a nurse to each unit to ensure timely responses to all alarms, and instituting an educational program for all nurses working with the monitoring systems. They note that these are interim steps as they work on more thorough and durable long-term solutions.

But the Globe article also quotes patient safety guru Lucian Leape as questioning why you would ever manufacture a critical alarm or monitor that allows staff to turn if off. A point that we have made over and over is that medical equipment is all too often designed in places other than where it will be used. Microsoft wouldn’t dream of designing software without looking to see how users interact with it. Yet many pieces of medical monitoring equipment are designed without observing over time how healthcare professionals will interact with it. Everyone who has ever worked in an ICU (or other critical care area) knows that the first thing a human responder usually does when an alarm goes off is: turn off the alarm! There is a huge difference in “pausing” an alarm (so you can attend to whatever that alarm was signaling) vs. disabling that alarm.

We encourage you to go back and carefully read each of the three previous columns mentioned above. They highlight the problems with design of alarms and the equipment the alarms are attached to, the design of the environments in which the alarms are used, and the problem of alarm fatigue. More importantly, when you read them, you will avoid the urge to rush out and take disciplinary action against any individuals in such cases. In virtually every case we have seen or investigated there are significant system issues (and usually cultural issues as well) that are the real root causes. Most striking along that line was the case discussed in our April 2, 2007 Patient Safety Tip of the Week “More Alarm Issues”. In that case, the teams investigating an incident in which the volume of an alarm in an ER had been turned down found exactly the same thing on three subsequent visits to the ER! On each occasion a different individual had turned down the volume. It was obvious this was a problem with design of the ER and a problem with safety culture on the unit.

The bottom line: when you find an alarm that has purposely been altered, keep looking – you will always find an important root cause that led to its being altered.

And when you find a specific problem with an alarm, don’t stop there. Go look at all the other equipment and sites using that same alarm. In the case described in our March 5, 2007 Patient Safety Tip of the Week “Disabled Alarms”, the finding of a piece of tape used to mute a ventilator blender alarm led to finding 6 other ventilators in the hospital system that had been similarly muted.

Alarms and alerts, whether audible or visual, are often poorly designed for the environments in which they are used. The indicator light on the portable ventilator in the April 2, 2007 case was on the rear of the ventilator in an area not readily visible. In the March 26, 2007 case the alarm did not immediately direct the attention of the nurse to the area of concern. And even the blender alarm described above in the March 5, 2007 case was poorly designed because it should have been anticipated someone might purposely silence the alarm during routine maintenance when oxygen was not being used.

Alarm fatigue is a real problem. Just as we see “alert fatigue” when physicians are exposed to too many alerts and reminders during CPOE, “alarm fatigue” refers to the human tendency to begin ignoring alarms when exposed to a constant bombardment by alarms, many of which are false alarms or not clinically important.

Sometimes we fail to ask the most important questions. One question seldom asked is “Why do we need so many alarms in the first place?”. That very question was asked in an article this month in Critical Care Medicine (Siebig et al 2010). They looked at clinical and physiological data and alarms used in patients in multiple medical intensive care units. Strikingly, they found that only 15% of alarms were considered clinically relevant. No wonder so many alarms get ignored! 40% of the alarms did not correctly describe the patient condition and were classified as technically false. A substantial portion of the alarms were caused by staff manipulating the monitoring systems (eg. during blood drawing).

Most alarms in the Siebig study were simple threshold alarms (meaning they alarm when a high or low threshold is exceeded). They, thus, don’t convey meaningful information about trends which may be even more important and would alert staff to clinical deterioration earlier. That article and the accompanying editorial (Blum 2010) call for future research into alarms and suggest development of monitoring algorithms that could monitor multiple physiological parameters simultaneously to identify clinically relevant changes earlier and more reliably. They also suggest using different audible tones to help differentiate various signals indicating problems with the electrodes versus problems with the patient.

Don’t forget that monitoring and alarm systems consist of much more than pieces of medical equipment (see our April 1, 2008 Patient Safety Tip of the Week “Pennsylvania PSA’s FMEA on Telemetry Alarm Interventions”). The Pennsylvania Patient Safety Authority’s “Alarm Interventions During Medical Telemetry Monitoring: A Failure Mode and Effects Analysis” analyzed data on alarm-related incidents from the Pennsylvania Patient Safety Reporting System and identified 29 steps involved in the telemetry monitoring process. They provide excellent recommendations regarding patient identification, optimal display location, ensuring the power source of the telemetry receivers, protocols for when monitoring is temporarily suspended or on standby (eg. during transport or while electrodes are being manipulated), protocols for alarm volume levels, electrode placements and inspection and maintenance, making alarm parameters appropriate to both the individual patient and the setting, and protocols for responding to all alarms (whether low- or high-priority alarms) including establishment of a tiered backup response system. They also point out a very important question easily overlooked in a FMEA “Is telemetry monitoring indicated in this patient at all?”.

Because people must set up the alarms it is no surprise that human error plays a big role in alarm-related incidents. Our June 19, 2007 Patient Safety Tip of the Week “Unintended Consequences of Technological Solutons” noted an adverse outcome related to transposition of telemetry receivers that were placed on two patients at about the same time. When the telemetry alarm-related incidents from the Pennsylvania Patient Safety Reporting System were analyzed, patient misidentification was one of the root causes seen fairly frequently.

Our quick list of things you should do to help avoid alarm-related incidents:

• Make alarm rounds a routine on all units
• Check alarms when you are doing patient safety walk rounds
• Spend some time on a busy unit observing how staff react to various alarms (eg. promptness, attention to the condition the alarm was intended for, how the alarm was reset, impact the alarm had on both staff and patient, etc.)
• Are workarounds being used?
• Use checklists in setting up equipment with alarms
• Staff Education – different brands and models may handle alarms differently
• When purchasing new equipment, consider how alarms differ from old equipment
• Always consider how alarms will impact any changes you plan in an environment
• Do you have redundancies? (If so, will staff over-rely on the redundancies?)
• Ask the following: “Do we really need this alarm?”
• Do a FMEA (failure mode and effects analysis) on alarms
• When you find an alarm was purposely altered, always look for real root causes

Alarms are wonderful safety devices. But, as we see with all technological advances, there are always unintended consequences. So vigilance and frequent auditing should become a routine part of your alarm safety program.

References:

Kowalczyk L. MGH death spurs review of patient monitors. Heart alarm was off; device issues spotlight a growing national problem. Boston Globe February 21, 2010

http://www.boston.com/news/health/articles/2010/02/21/mgh_death_spurs_review_of_patient_monitors/

Siebig S, Kuhls S; Imhoff M, et al. Intensive care unit alarms - How many do we need? Critical Care Medicine 2010; 38(2): 451-456

http://journals.lww.com/ccmjournal/Abstract/2010/02000/Intensive_care_unit_alarms_How_many_do_we_need___.13.aspx

Blum JM, Tremper KK. Alarms in the intensive care unit: Too much of a good thing is dangerous: Is it time to add some intelligence to alarms?

Critical Care Medicine 2010; 38(2): 702-703

http://journals.lww.com/ccmjournal/Citation/2010/02000/Alarms_in_the_intensive_care_unit__Too_much_of_a.54.aspx

Pennsylvania Patient Safety Authority. Patient Safety Advisory supplement “Alarm Interventions During Medical Telemetry Monitoring: A Failure Mode and Effects Analysis”. March 2008

http://www.psa.state.pa.us/psa/lib/psa/advisories/v5n1march_2008/mar_2008_medical_telemetry_fmea_supplementary_review.pdf

Patient Safety Tips of the Week pertaining to alarm-related issues:

March 5, 2007 “Disabled Alarms”

March 26, 2007 “Alarms Should Point to the Problem”

April 2, 2007 “More Alarm Issues”

June 19, 2007 “Unintended Consequences of Technological Solutons”

April 1, 2008 “Pennsylvania PSA’s FMEA on Telemetry Alarm Interventions”

February 23, 2010 “Alarm Issues in the News Again”

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March 2, 2010 

Alarm Sensitivity: Early Detection vs. Alarm Fatigue

Last week in our article on some of the hazards of alarms (February 23, 2010 Patient Safety Tip of the Week “Alarm Issues in the News Again”), we mentioned using alarms to pick up clinical deterioration earlier. This week we’ll discuss a couple articles where monitoring devices are used to identify that early clinical deterioration but highlight the problem of alarm sensitivity: balancing early detection vs. triggering too many false alarms that might lead to development of alarm fatigue.

The first article is one we already discussed in our What’s New in the Patient Safety World for February 2010 “Rapid Response Teams Still Not Cutting It”. The article by Taenzer et al 2010 discussed a new system of monitoring post-op orthopedic patients with continuous pulse oximetry at Dartmouth. Data from continuous pulse oximetry was analyzed by computer and tied to a system of notifying the patient’s nurse by pager. Key concepts were setting thresholds that met a balance between high sensitivity and numbers of false alarms. They also incorporated a delay into the notification system to further minimize the number of false alarms that nurses would have to respond to. The ultimate triggers used were an oxygen saturation of less than 80% and a heart rate below 50 or greater than 140. Their preliminary results show a reduction in rescue events and fewer transfers to the ICU. There were also fewer deaths, though the numbers were too small to be considered significant. This is an exciting concept and suggests that noninvasive monitoring tied to computer algorithms might someday operate in the background to help identify patients in need of early intervention.

Their discussion on balancing high sensitivity against false positives is excellent. They did observations for a month and noted that using an O2 saturation of 93% would have led to too many alarms. They found that 12% of data points in their postoperative occurred below that O2 saturation level. They note that such sensitivity might be appropriate in a setting with 1:1 care, but in a more general care setting it would distract nurses from other activities and likely lead to development of alarm fatigue where alarms might be responded to in a delayed fashion or not responded to at all. They also note that you must take into account individual patient characteristics as well. While the parameters they selected above may work well for the general population, those patients with pre-existing physiological abnormalities may need different settings. They therefore allowed nursing staff to make adjustments of parameters +/- 10% but any greater adjustments required a physician order.

The second article (Deitch et al 2010) looked at use of capnography during procedural sedation in the emergency department. Monitoring end-tidal CO2 during procedures in which IV sedation or IV opioids are used is theoretically very attractive since it is a better indicator of respiratory depression in such cases and should identify patients at risk before they develop oxygen desaturation. Their randomized controlled trial in adults undergoing propofol sedation showed significantly fewer patients with hypoxia in the group monitored by capnography. The 17% absolute risk reduction translates to a number needed to treat (NNT) of 6 cases to prevent one episode of hypoxia. Capnography recognized 100% of the patients who developed hypoxia and did so a median time of 60 seconds before hypoxia developed. That delay meant the physicians usually had adequate time to intervene.

It is extremely difficult to identify respiratory depression just by watching a patient. We have had medical students, residents, and attendings all observe patients on whom we had arterial blood gases and they did little better than chance at picking out which patients had respiratory depression. So the ability to identify patients with respiratory depression before they become hypoxic is a major potential advantage.

The editorial (Green & Pershad 2010) accompanying the Deitch study describes the pros and cons of adopting capnography routinely for such procedural sedation. The editorial notes that capnography clearly identifies respiratory failure before it is apparent by either clinical examination or pulse oximetry. And it acknowledges the significant contribution of the Deitch study, though it points out that some methodological issues (eg. using O2 at a flow rate of only 3L/minute and using an O2 saturation of 93% as the definition of hypoxia) may have overestimated the frequency of hypoxic events. And many episodes of hypoxia are self-limited and resolve without any intervention. In fact, 41% of the episodes in the Deitch study resolved without any intervention.

But Green & Pershad also note the substantial number of “nuisance” alarms. Combining the number of capnographic alarms that were not followed by hypoxia with the number of patients excluded because of data loss during capnography, they estimate the rate of “nuisance” alarms could be as high as 39%. They note that this may be even higher in procedures done in pediatrics because children tend to be less tolerant of the cannula and verbalization or crying will interfere with recordings. They point out it is unclear how physicians will respond to these nuisance alarms. So, while they like the concept they suggest that rather than becoming a routine standard, capnography might be best used in targeted situations such as sedation for radiology studies.

We have some of our own concerns. Will responding to the capnography alarms distract physicians from the procedure they are performing? First of all, we consider it very dangerous when the physician performing the procedure is also the person doing the monitoring. We find it hard to believe that you can keep full attention to both simultaneously. But does it happen (i.e. that one physician will be doing both)? Of course it does. And even if there is a separate person doing the monitoring, the alarms may still distract the physician from the procedure at hand.

But might there be other unintended consequences? One of the phenomena we like to point out is that described by Charles Perrow in his classic book “Normal Accidents” (Perrow 1999) where he talks about how new technologies often simply “push the envelope”. He cites as an example how the introduction of maritime radar simply encouraged boats to travel faster and did little to reduce the occurrence of maritime accidents. So will practitioners now give higher doses of sedatives or opioids, knowing that capnography will warn them of problems before hypoxia occurs? Will the safety margin engendered by capnography thus actually lead to more frequent episodes of serious respiratory depression?

The real lesson here is that when you plan to implement a new monitoring system with alarms you need to how often those alarms will trigger, what sort of responses you are likely to see, and how workflow will likely be impacted. Then you need to anticipate what workarounds may develop and what other unintended consequences are likely to occur. You can never anticipate all of the latter. So careful surveillance and auditing during the period after implementation of a new alarm system is critical.

References:

Taenzer AH, Pyke JB, McGrath SP, Blike GT. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-and-After Concurrence Study. Anesthesiology 2010; 112(2): 282-287

http://journals.lww.com/anesthesiology/Fulltext/2010/02000/Impact_of_Pulse_Oximetry_Surveillance_on_Rescue.10.aspx

Deitch K, Miner J, Chudnofsky CR, Dominici P, Latta P. Does End Tidal CO2 Monitoring During Emergency Department Procedural Sedation and Analgesia With Propofol Decrease the Incidence of Hypoxic Events? A Randomized, Controlled Trial. Annals of Emergency Medicine 2010; 55(3): 258-264

http://www.annemergmed.com/article/S0196-0644(09)01429-2/abstract

Green SM, Pershad  J. Should Capnographic Monitoring Be Standard Practice During Emergency Department Procedural Sedation and Analgesia? Pro and Con. Annals of Emergency Medicine 2010; 55(3): 265-267

http://download.journals.elsevierhealth.com/pdfs/journals/0196-0644/PIIS0196064409014462.pdf

Perrow C. Normal Accidents: Living with high-risk technologies. Princeton, New Jersey: Princeton University Press, 1999

Patient Safety Tips of the Week pertaining to alarm-related issues:

March 5, 2007 “Disabled Alarms”

March 26, 2007 “Alarms Should Point to the Problem”

April 2, 2007 “More Alarm Issues”

June 19, 2007 “Unintended Consequences of Technological Solutons”

April 1, 2008 “Pennsylvania PSA’s FMEA on Telemetry Alarm Interventions”

February 23, 2010 “Alarm Issues in the News Again”

March 2, 2010 “Alarm Sensitivity: Early Detection vs. Alarm Fatigue”

Print “Alarm Sensitivity: Early Detection vs. Alarm Fatigue”