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March 2007 ICSI Safe Site Protocol
The Institute for Clinical Systems Improvement ( ICSI ) has released its new Safe Site Protocol for All Invasive High-
Risk or Surgical Procedures (Protocol).
The New York State Department of Health (NYSDOH) released its revised New York State Surgical and Invasive
Procedure Protocol (NYSSIPP) in late 2006.
Both emphasize the importance of repeating the timeout verification process whenever there is a change in
personnel involved or a change in location of the patient.
Both closely mirror Joint Commissions Universal Protocol for Preventing Wrong Site, Wrong Procedure, and
Wrong Person Surgery.
Some great learning tools are available through the Utah C (Correct Patient, Correct Procedure, Correct Site)
Correct Site Surgery Initiative. Not only do they have a brochure for patients but they also used a tool from IHI to do a
Failure Mode and Effects Analysis for use of an OR Verification List.
Many of you involved in patient safety are familiar with Sidney Dekkers book The Field Guide to Human Error Investigations (2002). He has now followed that up with a new book The Field Guide to Understanding Human Error (Ashgate Publishing 2006) and this is a must-read for all involved in investigations of adverse events. Though much of his work has been in the aviation industry, Dekkers work in human factors and cognitive systems engineering is directly applicable to medicine and patient safety. He masterfully walks the reader through the ways to avoid hindsight bias, remain objective and focus on how the participants perceived the unfolding events at the time. After all, the focus of an investigation is to determine why the events happened in order to prevent similar events and adverse outcomes in the future.
The World Health Organization and Joint Commission and Joint Commission International have introduced "NinePatientSafety Solutions" through the WHO Collaborating Centre for PatientSafety Solutions.
The nine solutions include:
These solutions are downloadable in 3-4 page summaries that include suggested actions, potential barriers, potential unintended consequences, and references and other resources. They are an excellent resource for any organization in implementing their patient safety programs.
Many of you have already been familiar for several years withJohn Grouts website on mistake-proofing. Well, he has now put together a monographMistake-Proofing the Design of Health Care Processes that is available on the AHRQ website. There is also anAHRQ podcast with Dr. Grout discussing mistake-proofing in healthcare.
The most effective interventions we recommend in our root cause analyses (RCAs) are usually forcing functions or redesign of processes and equipment to direct one toward the most appropriate action. There are several examples in our Tip of the Week Archive.Grouts monograph provides numerous examples ofusing the principles of mistake-proofing to either avoid errors or to have errors result in more benign outcomes.
He begins with an overview of general mistake-proofing, human error, use of FMEA and CRM, and current state of patient safety activities. He points out that mistake-proofing is generally inexpensive and has a good ROI (return on investment). He also talks about the limitations and potential unintended consequences of such redesign efforts. He then presents numerous real-life examples of mistake-proofing implemented at various healthcare facilities around the country.
Overall, this is an excellent monograph that has many practical examples you may wish to implement in your patient safety activities. It will also help you in developing your own solutions to potential problems in your facilities. This is a nice complement to Donald Normans classic text on using design to prevent the wrong actions (Norman DA, The Design of Everyday Things. New York: Doubleday; 1989- also in paperback from Basic Books 2002).
Pennsylvania Patient Safety Authority: Preventing Wrong-Site Surgery
The June 2007 issue of the Patient Safety Advisory from the Pennsylvania Patient Safety Authority has an outstanding article on wrong-site surgery and the factors that may predispose to it.
There is an accompanying video presentation on Doing the Right Things to Correct Wrong-Site Surgeryand also a tip sheet for consumers.
The Pennsylvania experience suggests that wrong-site surgery is much more common than previously estimated. Their event reporting system differs from others in that near-misses are also reported so, unlike most other reporting systems, cases where no harm came to patients do get reported. Hence, the Pennsylvania experience is probably a much truer reflection of the incidence of wrong-site surgery. About a third of all Pennsylvania acute hospitals have reported cases of wrong-site surgery and there is an average of one wrong-site report per year for a 300-bed hospital.
The report lists numerous examples of cases of wrong-site surgery, sorted according to the types of factors that predisposed to the events. It then provides a thorough review of the predisposing factors, types of errors, and potential solutions, based not only on the Pennsylvania experience but also on a comprehensive review of the literature.
It discusses the Joint Commission Universal Protocol as well as multiple other safe-site protocols that are used (see also our March 2007 Whats New column) and provides references to multiple tools and resources available through many organizations to help prevent wrong-site surgery.
Kudos to John Clarke, M.D. and his team at the Pennsylvania Patient Safety Authority for this great contribution! This is truly a must-read for anyone involved in healthcare, regardless of whether they do surgery or not.
Responding to Patients with Clinical Deterioration
Given IHIs initiatives on rapid response teams andJoint Commissions new 2008 National Patient Safety Goal requiring a plan to Improve recognition and response to changes in a patients condition , it is most timely that 2 UK organizations have come out with guidelines on clinical deterioration in acutely hospitalized patients. The UK NHS National Patient Safety Agency just published its report Safer care for the acutely ill patient: learning from serious incidents and NICE (National Institute for Health and Clinical Excellence) has just released its clinical guideline Acutely ill patients in hospital. Recognition of and response to acute illness in adults in hospital .
The National Patient Safety Agency report analyzed serious patient incidents and found a large number of cases in which patients clinical deterioration was either not recognized early or not acted upon. Subthemes were that vital signs were often not appropriately observed or there was lack of recognition or lack of response to deteriorating vital signs. The second major theme was that rescuscitation skills and/or inadequate equipment often caused problems with cardiorespiratory rescuscitation. Action points recommended include not only providing appropriate standards and training, but also performing audits of codes and emergency equipment and standardization of rescuscitation equipment.
The NICE guidelines focus on 3 key areas: (1) identification of patients at risk for clinical deterioration or actually already deteriorating (2) response strategies, including timing, communication, and coordination of care between critical care teams and other specialties and (3) discharge of patients from critical care areas back to ward-based care, including monitoring requirements and timing of transfer. They stress the need for physiological track and trigger systems that help identify those patients in need of closer attention or intervention and use of a graded response strategy to those identified by the track and trigger scoring system. They discuss several scoring systems available. They have a good discussion of the key elements in the handover when patients are transferred back to the wards from critical care units. An interesting recommendation is that patients should not be transferred back to wards between 22:00 and 07:00 unless absolutely necessary. This was an evidence-based recommendation, though most of the studies were done in the UK, Canada, Australia, or countries other than the United States.
The NICE documents are well worth reading, particularly if one is interested in the evidence behind the recommendations.
Note that ICSI (Institute for Clinical Systems Improvement) has also just updated itsRapid Response Team Protocol .
Many hospitals participating in IHIs 100,000 Lives Campaign did not choose the Rapid Response Team initiative for a variety of reasons. Hospitals should recognize that they have not only a significant opportunity to improve patient and quality outcomes but also considerable opportunity to improve economic outcomes. Through good identification and response to the clinically deteriorating patient, one may avoid costly ICU admissions and readmissions and reduce ICU lengths of stay. The UK work, however, identified the current lack of a good evidence base on the cost-effectiveness of these systems.
The Impact of Abbreviations on Patient Safety
This months issue of the Joint Commission Journal on Quality and Patient Safety has an article on The Impact of Abbreviations on Patient Safety . This appears to be the first attempt ever to quantify the adverse effects of using abbreviations.
The study used the USP MEDMARX database of medication errors submitted between 2004 and 2006. It found that 4.7% of the error reports submitted were attributable at least in part to use of abbreviations.
Of the specific abbreviations implicated, QD in place of once daily accounted for 43.1% of all errors. That was followed by U for units (13.1%), cc for mL (12.6%), MSO4 or MS for morphine sulfate (9.7%), and decimal errors (3.7%).
The article further points out that compliance with the Joint Commission Do Not Use list standard remains problematic and has actually worsened between 2004 and 2006.
We previously gave some examples of significant problems with abbreviations in our March 12, 2007 and June 12, 2007 Tips of the Week. We have stressed that abbreviations on the Do Not Use lists should not be used anywhere in the chart. Many have felt that this applies only to orders but some of our examples demonstrate the dangers associated with their use anywhere in the chart (eg. H&P, progress notes, DC summaries, etc.).
Abbreviations remain a significant potential source for error and adverse patient outcomes. They need to be addressed at multiple levels. Medical records/coding personnel can look for them during their reviews. They can be a focus during Patient Safety Walk Rounds. They can be looked for during tracer methodology reviews of a patient during a hospitalization. Frankly, we like to make it a side exercise any time we are reviewing a chart for any reason. But when discussing the continued usage of these abbreviations, it is most helpful to be able to give some specific examples of cases in which use of these abbreviations clearly impacted negatively on patient care.
Surprisingly, on some pharmacy-oriented blogs on the web, there has been considerable negative opinion expressed about banning the abbreviation QD. Some have felt that banning such a time-honored abbreviation has had a downside at a time when we are trying to use once daily regimens more often (to promote patient compliance). Of course, any time we implement a solution for a problem, we are at risk of introducing unintended consequences. We need to remain very vigilant for unintended consequences. For example, how often might once daily in poorly legible handwriting be interpreted as twice daily? We suspect that does happen but probably a lot less commonly than mistaking a QD for a QID.
Pennsylvania PSA Advisory on Drug Labeling and Packaging
TheSeptember 2007 Patient Safety Advisory from the Pennsylvania Patient Safety Authority has another excellent article about medication errors related to drug labeling and packaging.
The advisory gives numerous real examples of such errors with pictures of many of the confusing labels. A particular problem seems to be confusion in the way the drugs strength or concentration is displayed on the label. This especially is a problem with multi-dose vials. They show the packaging on Kenalog-40 preparations side by side. One is for a 1 mL vial, the other a 5 mL vial. The respective labels say 40 mg and 40 mg per ml. The latter vial is often incorrectly interpreted to contain a total of 40 mg rather than the actual 200 mg. One facilitys solution is to store the different sized vials in separate areas in the pharmacy, stock only the 1 mL vials in other areas of the facility (including Pyxis machines), and use bar code technology to scan prior to stocking.
Since so many medication errors seem to involve multidose vials, we strongly recommend facilities always ask themselves why they ever need a multidose vial of a medication in areas other than the pharmacy. There may be circumstances where a multivial dose of a medication is needed but in most cases it is not really necessary and can only predispose to errors. All too often decisions about purchasing are made without input from the multiple disciplines that will actually be using the medications in their respective areas.
The advisory also discusses problems with medications whose concentrations are labeled as percentages or dilution ratios, and problems related to color-coding schemes.
The advisory also discusses the role of confirmation bias. They note that recent healthcare graduates initially read labels carefully but after time they begin to rely on appearance of familiar products and become less vigilant in reading labels.
They also provide several practical risk reduction strategies including:
They recommend reviewing the literature regularly to help identify problem-prone products. And they stress the importance of including information about contributing factors such as labeling and packaging when facilities report medication errors to regulatory agencies or other error reporting systems.
This is another outstanding contribution by the Pennsylvania PSA, ECRI, and ISMP.
More Patient Deaths from Luer Misconnections
Our July 10, 2007 Tip of the Week focused on catheter misconnections. The October 2007 issue ofFDA Patient Safety News highlights continued deaths from Luer misconnections and cites an excellent summary article by Gallauresi, Eakle, and Morrison inSafe Practices in Patient Care. It includes the history of the Luer connector, multiple real examples of misconnections, and the state of the industry in its attempts to develop standards to avoid this serious problem. It reiterates the recommendations of the2006 Joint Commission Sentinel Event Alert on this issue.
1000-fold overdoses by transposing mg for micrograms
TheSeptember 6, 2007 ISMP Safety Alert describes the caseofan infant who received a lethal dose of zinc stemming from an error that occurred during the order entry and compounding of a TPN solution. Because the automated compounder used for TPN required entry of zinc in a micrograms/kg dose, the pharmacist converted the micrograms/mL dose to a micrograms/kg dose. The pharmacist performed this calculation correctly, but accidentally entered the zinc dose in the pharmacy computer in mg, not micrograms. This resulted in a final concentration that was a 1,000-fold overdose. The ISMP provides a very good root cause analysis of the event, noting multiple system errors, and provides multiple recommendations for safe practices.
In our July 31, 2007 Tip of the Week dedicated to errors in use of neuromuscular blocking agents (MNBAs), we recommended this is a good issue to address in FMEA (Failure Mode and Effects Analysis) in your organization. Susan Paparella, from ISMP, did exactly that in a recent issue of Journal of Emergency Nursing. The ED staff had recognized NMBAs as high-alert drugs and were contemplating their removal from ED stores, to be replaced in kits prepared for rapid-sequence intubation. FMEA is especially useful in such situations where change is to take place, because it helps identify potential unintended consequences. The article nicely describes how you do a FMEA exercise and provides examples for scoring probability and severity and use of a hazard scoring matrix. She also lists 10 other problems commonly encountered in emergency rooms that could be candidates for FMEA.
Paparella, Susan RN, MSN Failure Mode and Effects Analysis: A Useful Tool for Risk Identification and Injury Prevention. Journal of Emergency Nursing. 33(4):367-371, August 2007
Our August 21, 2007 Tip of the Week quantified the cost of several complications that are potentially preventable. Add to that the costs of adverse events in ICUs. Kaushal et al have just published a study of the cost for adverse events in ICUs. The average cost per adverse event for patients in the MICU was $3961 and the attributable increase in LOS was 0.77 days. Corresponding numbers for patients in the CCU were $3857 and 1.08 days. The extrapolated annual cost for adverse events in these two 10-bed ICUs was nearly $1.5 million. Clearly, there is significant opportunity for costs savings in prevention of adverse events in this setting. Organizations looking for a good ROI (return on investment) in their patient safety programs may want to focus on ICUs.
Kaushal R, Bates DW, Franz C, Soukup JR, Rothschild JM. Cost of adverse events in intensive care units. Critical Care Med 2007; 35: 24792483
The American College of Radiology issued its guidance document for safe MR practices in the June issue of theAmerican Journal of Radiology.
Kanal E et al. ACR Guidance Document for Safe MR Practices: 2007. AJR 2007; 188: 1-27
This ones not really new but we just came across it. In our May 1, 2007 Tip of the Week we talked about the need for all physicians to have a system for tracking patient test results to help avoid such disasters as the missed cancer. The Kentucky Medical Association published a nice tool for Tracking Test Results Within a Physican Practice. It provides solid advice on setting up a system in your office, whether electronic or paper-based.
However, even computerized alert and reminder systems arent 100% successful.Singh et al reported followup on 1017 imaging report alerts transmitted electronically. They found that over a third of the alerts went unacknowledged, including 4% of abnormal results. Overall, 0.2% of outpatient imaging was lost to followup. Clearly, we still have a long way to go in fixing the barriers and system issues in ensuring test results get appropriately acknowledged and acted upon.
Singh H, Arora HS, Vij MS, MDc, Rao R, Khan MM, Petersen LA. Communication Outcomes of Critical Imaging Results in a Computerized Notification System .J Am Med Inform Assoc. 2007; 14:459-466
This Perspective by Tom Delbanco and Sigall Bell in the October 25, 2007 issue of theNew England Journal of Medicine provides insights gleaned from interviews with patients and families that had been affected by medical error. It provides excellent insight into how those same emotions in clinicians may further compound the emotions the patient or family is going through. Its another compelling example of why honest disclosure and sincere apology are the right thing to do after medical error.
Delbanco T, Bell SK.Guilty, Afraid, and Alone Struggling with Medical Error. NEJM 2007; 357:1682-1683
Whats Old is Whats New
1000-fold heparin overdoses back in the news again
It was only a year ago that the news headlines highlighted the story of three infants dying at an Indiana hospital due to overdoses of heparin used to flush vascular access lines.
ISMP issued a warning at that time in its September 21, 2006 Newsletter. The automated dispensing cabinet on the neonatal unit had been inadvertently stocked with heparin vials containing 10,000 units/mL. Nurses were used to drawing heparin from 10 units/mL vials from that cabinet and did not notice the difference (the ISMP Newsletter had photos of the vials, noting their similarity). ISMP pointed out the hazards of stocking automated medication dispensing machines, especially on neonatal and pediatric units because they are especially high-risk patients. They noted that a double check of all medications as they leave the pharmacy is important but not fool-proof. They also made a renewed call for vigilance for look-alike/sound-alike (LASA) items and strongly recommended use of barcoding as a patient safety tool. They pointed out that even when bedside barcoding is not available, barcode systems are available for many of the automated dispensing machines to help ensure proper stocking of those machines.
ISMP said in that 2006 Newsletter that similar medication errors could probably happen in most hospitals. Sadly, it has occurred again under almost identical circumstances, though this time without apparent harm to the infants affected. These cases made national headlines because 2 of the 3 infants receiving the errant dosages were children of actor Dennis Quaid. Lucian Leape, M.D., the most well-known authority on medical errors, pointed out that such errors can occur even at facilities with good track records, noting that Cedars-Sinai has been a leader in patient safety.
Baxter, manufacturer of the products reported to have been used in the incidents at both hospitals, had issued an alert to hospitals (including photos of the vials that might be mixed up) in February 2007 and had begun repackaging to make the two dosage strengths more distinctive. However, many hospitals had continued to use old stock of these medications and had not yet switched over to the newly repackaged drugs.
ISMP, in its November 29, 2007 Newsletter, reiterated its recommendations about double checks of all drugs leaving the pharmacy destined for floor stock and using barcoding. It also suggested using prefilled syringes of heparin flush solutions rather than using vials of heparin flush on the units. They also have a link to a recording of a February 2007 presentation about the Indiana cases. And they remind facilities to make sure they replace any old stock with the newly repackaged stock from Baxter. The ISMP Newsletter then editorializes about our failures to adopt a true learning culture and to be truly mindful about safety.
According to the LA Times, Cedars-Sinai has apparently removed all heparin used for peripheral IV flushes from the pediatric unit and will instead use only a saline solution for flushes for both pediatric and adult units. In addition, the higher concentration heparin vials will be stored separately in the pharmacy from heparin in the lower concentration. They will also be retraining all nursing and pharmacy staff in medication administration. They are also contemplating a barcoding system.
Anticoagulants remain high-alert drugs and Joint Commission has added a new national patient safety goal for 2008:3E Reduce the likelihood of patient harm associated with the use of anticoagulation therapy.
Fortunately, there does not appear to have been any actual patient harm in the most recent cases. However, the occurrence of these incidents and the preceding ones provides some valuable lessons learned.
They serve as a good reminder that double checks remain weak solutions in any root cause analysis. Human error rates in many industries show error rates of 10% or higher when someone checks the work of someone else. So even though you should not abandon your double checks before medication administration, you must have other protections in place as well.
Secondly, Joint Commission requires facilities to incorporate failure mode and effects analysis (FMEA) into their quality improvement activities. When we are asked what problems a facility might consider for a FMEA, hi-alert drugs are always at the top of our list. Doing FMEA for processes related to anticoagulants is important not only in helping to prevent errors but may also be very valuable in helping you to respond quickly and appropriately to prevent patient harm in the event that such an error actually occurs.
Thirdly, Joint Commission also requires your organization systematically review look-alike/sound-alike medications as part of your medication safety program. Too many organizations spend most of their time on the sound alike portion and not enough time on the look alike side, especially looking at packaging and labeling.
A fourth lesson is more philosophical. There are certain medications that clinical staff often dont consider to be medications. Heparin flushes are probably one of those. IV solutions are another. We need to do a better job of reminding staff about all potentially dangerous things.
Fifthly, automated dispensing machines have been a godsend for most organizations and have undoubtedly contributed to improvement in both efficiency and patient safety. However, they do bring their own set of potential problems. You should be looking to ensure that they are tied to other technological patient safety initiatives such as barcoding and computerized physician order entry (CPOE). In the meantime, consider them as another topic for FMEA.
Lastly, think about how your organization responds to alerts that are put out by critical incidents occurring anywhere. Dont wait for something bad to happen at your facility. Make sure that part of your routine patient safety activities is responding to alerts put out by the FDA, ISMP, Joint Commission, your state Department of Health, or other reputable organizations that issue alerts. One item on your monthly quality improvement/patient safety agenda should be Industry Alerts and Concerns and someone should be charged with scanning the appropriate resources for such alerts.
The December issue of The Joint Commission Journal on Quality and Patient Safety has an article on an award-winning MRSA intervention by Evanston Northwestern Healthcare.
They found a high point prevalence for MRSA colonization and developed and implemented a MRSA control plan based on IHIs 5 Million Lives Campaign recommendations for MRSA control. A prior ICU-based MRSA surveillance program had had little impact on overall MRSA infection rates but may have been helpful in fostering awareness when they rolled out their universal surveillance process. The article details how they developed the implementation plan and business plans, communication and training plans, and data monitoring.
In addition to educating key constituents, other critical factors were development of order sets, ensuring adequate resources for patient isolation, and deciding which test for MRSA to use. Ultimately they chose a PCR test for MRSA because of its sensitivity and rapid turnaround time. One of the keys, however, was ensuring availability of additional laboratory personnel to do all the screening tests promptly.
65% of inpatients identified as MRSA carriers had not been previously known to their infection control program. In the first year of universal surveillance, they found a 13-fold reduction in MRSA transmission and an 80% reduction in MRSA bloodstream infections.
The net cost of the intervention was about $15 per admission and their calculation of cost savings of the intervention showed it was at least cost-neutral (their conservatism and modesty kept them from highlighting that the calculated return on investment was almost double the cost invested).
This is another great example of how healthcare facilities are demonstrating that complications once thought to be unavoidable are now being dramatically reduced. Kudos to IHI, Joint Commission, and Evanston Northwestern Healthcare for this lesson that other organizations can learn from.
Peterson LR, Hacek DM, Robicsek A. Case Study: An MRSA Intervention at Evanston Northwestern Healthcare. Joint Commission Journal on Quality and Patient Safety. 2007; 33: 732-738 (http://www.jcrinc.com/fpdf/pubs/pdfs/JQPS-12-07-peterson.pdf)
The December 2007 issue of the Pennsylvania Patient Safety Authoritys Patient Safety Advisory also has a timely article on MRSA Prompt Identification and Effective Communication of Status May Reduce MRSA Infections. The Pennsylvania Patient Safety Reporting System has had over 1700 reports on MRSA since its inception and they have been able to identify numerous barriers to prompt identification and isolation of cases. They also note data from the Pennsylvania Health Care Cost Containment Council that shows the average cost of hospitalization for a MRSA-infected patient is $87,990 compared to $28,711 for those without MRSA infection (based on 2004 data). In addition, mortality rates are 4 times higher in MRSA-infected patients and average length of stay up to 8 days longer.
The advisory gives numerous examples of delays in identification of MRSA status or implementation of isolation of patients.
The report details the important components of a MRSA prevention/containment program. Active surveillance is a fundamental component. While the Northwestern program above chose universal screening and use of a PCR technique, other hospitals have chosen active screening of high risk patients and used nasal swabs for culture. They note high risk patients are nursing home patients, ICU patients, patients with recent invasive procedures, HIV infection , IV drug abuse, hemodialysis, age over 65, recent or long-term antibiotic use, and previous MRSA infection or colonization. They also note that computer technology can be used to alert staff of patients with current or previous MRSA infection or colonization.
They note that standing orders for MRSA screening on the target population are helpful and discuss the educational or training programs needed for various staff, patients and families. They stress that proper communication of MRSA status to all constituents is critical.
They go on to discuss the CDC-recommended isolation procedures for patients infected with or colonized with MRSA. They conclude with a section on prevention of MRSA transmission by proper hand hygiene programs (good description of the important components of a good hand hygiene program) and important details about use and care of equipment carried by healthcare workers and appropriate cleaning of hospital beds and surrounding patient environment.
This is an excellent and timely article that nicely complements the Northwestern article noted above.
Pennsylvania Patient Safety Authority. Patient Safety Advisory: Prompt Identification and Effective Communication of Status May Reduce MRSA Infections. Pennsylvania Patient Safety Authority Patient Safety Advisory 2007; 4: 124-129
In addition to this months column above, there are some other important new patient safety issues wed like to point out. We ended last year with a discussion of heparin flush overdoses and a recommendation that part of your routine patient safety activities is responding to alerts put out by the FDA, ISMP, Joint Commission, your state Department of Health, or other reputable organizations that issue alerts. It turns out that this month was an active one for the FDA MedWatch site for product recalls. Some of the more important ones are below:
Alaris pump recall
Cardinal Health announced a voluntary recall for all Alaris Pump modules, model 8100 (formerly known as Medley Pump module), shipped prior to September 27, 2007 because the units may contain misassembled occluder springs (bent, broken, nested or missing) that occurred during manufacturing. Misassembled springs could lead to overinfusion that could result in serious adverse health consequences or death. Overinfusion may be difficult to detect because the misassembled springs can work intermittently, and there is no warning or notification of an overinfusion. There is a link to the manufacturer's press release and another for a list of the serial numbers for the affected devices.
Bayer Diabetes Care Contour Test Strips (TS)
Bayer Diabetes Care notified healthcare professionals and consumers of a voluntary market recall of test strips (sensors) used exclusively with the Contour TS Blood Glucose Meter because test strips from specific lots could result in blood glucose readings with a positive bias that could demonstrate 5 - 17% higher test results. This issue is unrelated to the Contour TS meter itself and pertains only to certain test strips used with the meter. There is no impact on the performance of strips with other Bayer meters. Healthcare professionals, retailers, patients and other customers who use Contour TS are advised to check the lot number of the test strips in their inventory (affected lot numbers are provided in the manufacturers press release and contact Bayer Diabetes Care for information regarding the return and replacement of strips.
Just watched back-to-back TV ads for the umpteenth time the past 2 months. The first was for Mirapex for restless leg syndrome (my RLS, as the actress emphasizes!), followed immediately by an ad for MiraLax for constipation. I chuckled Wonder what will happen to those restless legs when she gets the MiraLax instead!. And, of course, that mistake has already happened.
Its really no matter for levity. Weve discussed the problem of look-alike/sound-alike (LASA) drugs on multiple occasions. This week the USP released its 8th annual MEDMARX Data Report and it shows an astounding increase in medication errors due to LASA drugs. Between 2003 and 2006 they identified 1470 drugs involved in LASA errors. This leads to their list of 3170 drug pairs that contribute to LASA errors. That number is almost double the number that had been identified in USPs last list in 2004. About 1.4% of the errors led to patient harm and USP points out that the percentage causing harm has consistently been above 1% now for the past 7 years. And the top 10 drugs sold in the US all made the list.
No part of the health care continuum is immune from LASA errors. And some of the drugs on our hi-alert lists are also involved in LASA errors (see our July 31, 2007 Patient Safety Tip of the Week Dangers of Neuromuscular Blocking Agents).
But some other errors noted in the MEDMARX report are unintended consequences of our attempts to reduce errors. We are, of course, talking about errors related to computerization. We are strong advocates of use of CPOE because it reduces many errors related to illegible handwriting. But we have seen replacement of handwriting errors with what we call the cursor error (or stylus error if you are using a PDA). This refers to the unintentional choosing of the wrong drug from a list on a computer.
One of USPs recommendations is one that we have stressed over and over the need to include on any order or prescription the indication for the medication. That should apply whether one is entering the order into a computer or writing a prescription on paper. It gives the pharmacist or nurse the opportunity to say wait a minutethat drug is not used for that indication and results in an opportunity to intercept an error before it leads to patient harm. With decision support built into CPOE proper programming is necessary to check that the drug and the indication are compatible.
Use of tall man lettering for LASA drug pairs (see our August 14, 2007 Patient Safety Tip of the Week More Medication-Related Issues in Ambulatory Surgery) is another USP recommendation.
Using generic names rather than brand names has been suggested as a possible solution but LASA errors may also occur with generic names.
Verbal orders can especially be problematic in leading to LASA errors. Verbal orders, of course, should be avoided where at all possible. When they cannot be avoided, hearback and spellback must be used to clarify all details of the order. Some organizations have not allowed verbal orders that pertain to specific LASA pairs.
Another recommendation is that LASA pair drugs should not be stocked in proximity to each other in the pharmacy or any other area where drugs may be stocked.
Clearly, look-alike/sound-alike medication error prevention needs to be an important component of your patient safety program. Every introduction of a new drug adds yet additional opportunities for LASA errors and we can expect the frequency of these events to further increase unless strong system interventions are put in place.
Other newsworthy patient safety items recently:
The Minnesota Department of Health released its Adverse Health Events in Minnesota: Fourth Annual Public Report.The report provides some insight into the root causes and potential solutions for falls, decubiti, wrong site surgery, and objects retained during surgery.
This site builds upon AHRQs wealth of patient safety resources that may be used by patients or families. From AHRQs Medical Errors & Patient Safety web page you can access not only a whole host of documents on patient safety aimed at professionals but also many useful patient safety resources for patients and consumers.
Most of you are probably already familiar with AHRQs 20 Tips to Help Prevent Medical Errors, a fact sheet you can give your patients and their families and friends. There is also the companion fact sheet 20 Tips to Help Prevent Medical Errors in Children.
Ways You Can Help Your Family Prevent Medical Errors! provides some of the same questions with cartoon illustrations. And How to Create a Pill Card illustrates how one can make a personalized card that helps patients remember how and when to take their medications, with illustrations and pictures of the medications.
One of our favorites is Be prepared for medical appointments. This is a great tool that helps your patients develop their own list of questions to ask on medical visits. It includes sample questions to ask about prescriptions, diagnostic tests, surgery.
These tools are also nice complements to Joint Commissions Speak Up program tools.
Print AHRQs Healthcare411
Our January 29, 2008 Patient Safety Tip of the Week Thoughts on the Recent Neonatal Nursery Fire discussed a fire in a neonatal nursery incubator in Minnesota and the ongoing investigation into the causes. We mentioned that we have always been somewhat surprised that fires in patient care areas other than surgical suites seem to be seldom reported. Well, last month within the space of two hours in two separate hospitals in India two infants died from incubator fires. So such occurrences may not be so rare. A short circuit was suspected in one of the cases but a full root cause analysis is not yet available. We still anxiously await the results of the investigation in the Minnesota case and these two cases to identify contributing factors and causes. In the interim, many of the components mentioned in our December 7, 2007 Patient Safety Tip of the Week on Surgical Fires should be emphasized, as well as all the excellent work done by ECRI on surgical fires.
And, again, given the risk of fires in incubators hospitals need to take a careful look at the clinical indications for use of concentrated oxygen and have evidence-based criteria not only for starting oxygen therapy but also for its continuation and discontinuation.
Update: See also our Whats New in the Patient Safety World column for March 2009 Followup on the Minnesota Bassinet Fire.
We discussed nosocomial urinary tract infections in our May 8, 2007 Tip of the Week Doctor, when do I get this red rubber hose removed? and our January 8, 2008Patient Safety Tip of the Week Urinary Catheter-Associated Infections. In the latter, we focused on a paper by Sanjay Saint, M.D. and colleagues at the University of Michigan Preventing Hospital-Acquired Urinary Tract Infection in the United States: A National Study in the January issue of Clinical Infectious Diseases.
A related paper by Saint et al. discusses themes arising from their study. They found that even though preventing hospital-acquired UTI was a low priority for most hospitals, there was substantial recognition of the value of early removal of a urinary catheter for patients. Second, those hospitals that made UTI prevention a high priority also focused on noninfectious complications and had committed advocates, or champions, who facilitated prevention activities. Third, hospital-specific pilot studies were important in deciding whether or not to use devices such as antimicrobial-impregnated catheters. Finally, external forces, such as public reporting, influenced UTI surveillance and infection prevention activities.
Another article in that same journal (Raffaele 2008) found 30% of urinary catheters were clinically inappropriate. This article has a good discussion of the appropriate indications for urinary catheters and identifies some of the factors that were associated with inappropriate use.
Saint S, Kowalski CP, Forman J,Damschroder L,Hofer TP,Kaufman SR,Creswell JR,Krein SL. A Multicenter Qualitative Study on Preventing Hospital-Acquired Urinary Tract Infection in US Hospitals. Infect Control Hosp Epidemiol 2008;29:333341 http://www.journals.uchicago.edu/doi/abs/10.1086/529589
Raffaele G, Bianco A,Aiello M,Pavia M. Appropriateness of Use of Indwelling Urinary Tract Catheters in Hospitalized Patients in Italy. Infect Control Hosp Epidemiol 2008;29:279281 http://www.journals.uchicago.edu/doi/abs/10.1086/528814?prevSearch=(raffaele)+AND+[journal:+iche]
Our December 2007 Whats New in the Patient Safety World column discussed the continued occurrence of 1000-fold heparin overdoses. This included discussion about the Cedars-Sinai incident involving, among others, the children of actor Dennis Quaid and the previous Indianapolis incident that resulted in death of 3 infants. We discussed many of the ISMP recommendations and listed multiple lessons learned.
Dennis Quaid did an interview on CBSs 60 Minutes recently to highlight this problematic issue. The 60 Minutes piece did a good job of keeping the issue of medical errors in front of the public and focused a great deal on the fact that the two different heparin solutions had come in vials that looked very much alike. The piece did not delve into many of the systems issues previously raised by ISMP or some of the system lessons learned we had in our December column. However, the Quaid family is apparently leading an effort to promote bar-coding initiatives more widely.
ISMPs March 27, 2008 Newsletter has an excellent followup Theres more to the 60 Minutes story on heparin errors. It discusses the role that confirmation bias may have played in both the Cedars and Indianapolis incidents as well as in many other medical errors. And it really highlights the fact that human error will continue to occur so we need better systems in place to intercept those errors before harm comes to patients. They make a major case for implementation of systems such as bar-coding. Lastly, they discuss the importance of dissemination of lessons learned from incidents elsewhere and the issue of when to do recalls of products implicated in safety threats.
Weve had several recent columns on 1000-fold heparin overdoses related to heparin flushes. Our December 2007 Whats New in the Patient Safety World column discussed the continued occurrence of 1000-fold heparin overdoses. This included discussion about the Cedars-Sinai incident involving, among others, the children of actor Dennis Quaid and the previous Indianapolis incident that resulted in death of 3 infants. We discussed many of the ISMP recommendations and listed multiple lessons learned. There was also followup in the April 2008 Whats New in the Patient Safety World column.
Now the National Patient Safety Agency of the UK NHS has just issued an alert Risks with Intravenous Heparin Flush Solutions. Timely because of all the recent cases of heparin overdose in the US due to inadvertent administration of high dose heparin, the alert was actually issued after an extensive root cause analysis in the UK of inadvertent high dose heparin administered by an anesthetist during procedures of 4 successive pediatric patients. Though the investigator had difficulty identifying other cases from the UK incident reporting system (because of problems with data structure and taxonomy of the database), he did find at least one other comparable case. The cases are very similar to the ones in Indiana and California that have received substantial media attention in the US.
The alert and its additional information point out that heparin flushes have no advantage over normal saline for maintaining peripheral intravenous catheters (evidence is less clear for arterial catheters or central venous catheters). Though there is minimal drug cost savings in moving to use of normal saline for such flushes, keep in mind that unnecessary use of heparin also exposes patients to the risks of allergic reactions, bleeding complications, medication error, and heparin-induced thrombocytopenia. And some other medications may be incompatible with heparin when injected into the same catheter. The alert also stresses that heparin flushes should not be routine and should only be used when specifically prescribed. It also reaffirms previous NPSA recommendations on injectable medications such as only stocking low-dose heparin products in areas other than pharmacy, correctly labeling all syringes, and using double checking systems when preparing medication for injection and when administering such injections.
But the real value in this alert is the independent review/RCA, which is extremely thorough and highlights a whole host of circumstances, human factors, and errors that combined to produce the incident(s). This is a long (and often repetitious) investigation report but we highly recommend you read it in its entirety. Its filled with many of the things weve talked about in numerous columns: time pressures, look-alike/sound-alike (LASA) drugs or packaging, information overload, workarounds, drugs showing up in unexpected places, confirmation bias, failure to communicate important patient safety policy changes, failure to convey important clinical information to those who needed to know, slips, latent errors, culture of safety issues and a host of others. Though its not presented in a structured RCA format, most of the key elements of the RCA are readily perceived. And the lessons learned and multiple recommendations made would be good ones for almost any healthcare facility.
In a nutshell, 4 pediatric oncology patients were to have procedures (bone marrow aspirates, lumbar punctures, etc.) performed under anesthesia in a treatment room in an outpatient area. Each patient was to receive a heparin flush of their access line. The anesthetist, unaware that vials of high-dose heparin (25,000 units in 5 ml) had inadvertently been placed in the controlled drug cupboard (CDC), administered the high-dose heparin to each child thinking he was using a low-dose heparin flush (50 units in 5 ml). He, nor other staff involved in the care of these patients, recognized the errors. By chance, because parents of the children had noted some excess bleeding from puncture sites and nurses performing routine inventory of the medication cabinets noticed missing high-dose heparin vials, the incident was discovered the following morning. Fortunately, no long-term harm came to any of the affected children.
Some enabling conditions were identified. The anesthetist had arrived to the facility somewhat late and, to avoid inconvenience to the patients and their families, proceeded without taking a rest break or lunch break (time pressure).
He examined the four patients who were to have procedures done that day, then went to the treatment room to begin preparation for the procedures. He laid out the anesthetics tray for each of the four cases and syringes for each of the three medications each patient was to receive (they were all to receive the same medications). He did not label any of the syringes. Rather he was using his own method of recognizing what was in the syringe by the size of the syringe. This is an example of a workaround. Not only are there dangers in the failure to label the syringes but the preparation of medications for multiple patients at the same time is also extremely dangerous.
The high-dose heparin was not supposed to be in the CDC. It had been placed there because another adult patient had needed it on several occasions. The box containers for the two heparin preparations were distinctive. However, the four vials of high-dose heparin were not in the box container. The actual vials were difficult to distinguish from the vials of low-dose heparin. The anesthetist filled a syringe from each tray with the high-dose heparin, not realizing it was the wrong heparin preparation (look-alike/sound-alike or LASA issue). In such cases, confirmation bias likely plays a significant role: the vials looked like the ones he expected to use and even the word heparin appeared on the vials. Failure to read the exact label obviously was an error. However, it is clear from multiple similar occurrences of these incidents, that such confirmation bias is common and may affect even experienced well-intentioned healthcare workers. In fact, experienced staff are probably more prone to confirmation bias than inexperienced staff.
At no point during either the preparation of the injectable medications or their administration was a double check performed (i.e. a second observer did not independently verify the correct medication, dosage, route, and patient). Though this was required by policy, this anesthetist and most others were unaware of the requirement (see below in section on policy issues). Also keep in mind that good medication safety also requires verification of the medication at the time of disposal. In this case, the anesthetist simply discarded the used heparin vials in a sharps container.
The investigation does note the controversial issues related to double checks (i.e. that the second checker is more prone to error and, in fact, both checkers may be more prone to error because they assume the other checker correctly verified all the information). However, he cites two research studies that showed a roughly 30% reduction in drug errors with a double checking system.
Another problem identified was that the controlled drug cupboard had over time become an area where many things other than controlled drugs were kept (including personal valuables) and had become vulnerable to access by extraneous staff. In fact, the keys to that CDC were used by so many people that it was often difficult to locate the keys. Hence, one wonders if this had made it more likely unexpected drugs would show up in the CDC. This is an issue of the nature of the local culture of safety. The CDCs in similar rooms also differed. This was due to an old CDC being moved from the old facility. It exemplifies the importance of standardization.
The anesthetist involved and most of the other anesthetists were unaware of the policy that double checks were required for preparation and administration of intravenous drugs. This was largely a result of policies being too long (some as long as 60 pages), important points not being highlighted, and changes not being highlighted. As a result the policies often went unread by those who needed to see them. And the organization had no formal means of assessing who had read the policies or policy changes. This is an example of both failure of communication and information overload. Sound familiar in your facility?
The investigation also revealed some after-the-incident issues. Parents of two of the children called that evening noting excessive bleeding at puncture sites. That information was never conveyed to the day staff. The following morning the parents of one child brought their child in because of the bleeding. The bleeding had stopped and the child was discharged home. A short time later the vials of high-dose heparin were noted to be missing and it became apparent what had happened. That lack of communication between the evening on-call staff and the daytime staff almost allowed a serious incident to go undetected.
The staff at the outpatient area also had no guidance as to how to proceed with an investigation once the incident was recognized. Having a policy and checklist for what to do in such cases would have been usual (see our July 24, 2007 Patient Safety Tip of the Week Serious Incident Response Checklist).
The investigation report provides 51 recommendations regarding changes needed at multiple levels of the pertinent health care systems. The reader is referred to the full investigation report for all those details.
NHS NPSA Rapid Response Report.
Risks with Intravenous Heparin Flush Solutions. April 24, 2008
Rapid Response Report: Risks with Intravenous Heparin Flush Solutions
(Reference: NPSA/2008/RRR02) issued on 24 April 2008
Evidence on heparin flushes recently reviewed by UK Medicines Information (UKMi) indicates no advantage over normal saline for maintaining peripheral intravenous catheters. http://www.druginfozone.nhs.uk/Record Viewing/viewRecord.aspx?id=591809
Toft B. Independent review of the circumstances surrounding four serious adverse incidents that occurred in the Oncology Day Beds Unity, Bristol Royal Hospital for Children on Wednesday, 3 January 2007. (UHBT Final Report Heparin). August 2007 www.ubht.nhs.uk/documents/oct_UBHT_final_report_heparin.doc
Other heparin-flush discussions on our website:
Our January 15, 2008 Patient Safety Tip of the Week Managing Dangerous Medications in the Elderly focused on prescribing of medications on Beers List that may be potentially inappropriate for elderly patients. That column discussed the origin and updating of Beers List and ways to improve medication management in the elderly. Most of the published literature on Beers List has focused on outpatient or nursing home settings. Relatively little attention has focused on patterns of prescribing for hospitalized elderly inpatients.
An article by Rothberg et al (2008) recently published in the Journal of Hospital Medicine sheds some light on use of such medications on the inpatient side. They found that almost half of all inpatients over the age of 65 in a widely representative hospital sample received at least one medication meeting criteria as a potentially inappropriate medication (PIM) from the Beers classification. 49% received at least one PIM, 38% received at least one PIM with a high severity rating, and 6% received 3 or more PIMs.
Prescribing of high severity PIMs varied substantially across attending physician specialities, being highest for cardiologists (48%) and lowest for geriatricians (24%). Internists, family practitioners, and hospitalists all had median rates of 33%.
There was also great variation across hospitals in PIM usage, especially by geographic location. PIM usage ranged from 34% in the Northeast to 55% in the South. Teaching status of the hospital had little impact. Smaller hospitals had better rates than larger hospitals. Having geriatricians on staff also improved overall hospital prescribing of PIMs. Patients older than 85 were much less likely to receive a PIM than those aged 65-84 and there was some variation depending on the specific reason for hospitalization.
Note that the study, which was based on review of administrative data, was not able to determine which PIMs might have been continuation of medications prescribed prior to admission vs. medications newly started in the hospital. The process of medication reconciliation, which is now done on admission and discharge and should be done at all transfers of care, offers a good opportunity to minimize use of PIMs. In our previous column, we mentioned that when a system in the outpatient setting notifies physicians that one of their patients is on a drug that is on the Beers List, the physician seldom discontinues the flagged drug in that individual patient. However, the number of new prescriptions for that drug diminishes in the patient population cared for by that physician. Perhaps the event of hospitalization may present the opportunity to reassess the potential benefits and risks of those drugs and might lead to their discontinuation.
As we implement CPOE (computerized physician order entry) with clinical decision support, alerts can be programmed to trigger when a PIM is ordered on a patient over a specified age. To minimize the number of alerts a physician may encounter (to avoid alert fatigue), we usually try to use standardized order sets wherever possible. However, the Rothberg article raises the possibility that sometimes the standardized order set, which often fails to take into consideration the age of the patient, might actually promote use of certain PIMs. Therefore, organizations would be wise to review their standardized order sets to see whether any modification for Beers list medications is desirable.
While, to our knowledge, no one has ever validated the significance of Beers List for inpatients, common sense tells us that many of the medications on the list are potentially dangerous for elderly inpatients. Certainly, the sedating agents and several of the medications that produce orthostatic hypotension will increase the risk of falls. And the sedating agents, analgesics, muscle relaxants and anticholinergic agents all have the potential of precipitating or aggravating delirium. Falls and delirium are of importance not only from a human standpoint, but both are on the list of complications for which CMS will no longer be paying come October 2008 (though see our April 22, 2008 Patient Safety Tip of the Week CMS Expanding List of No-Pay Hospital-Acquired Conditions where we speculate that delirium may not make the final cut). And several of the drugs may depress respiration or predispose to aspiration or inspissation of secretions, all potentially complicating several conditions that might have led to hospitalization. So while the evidence base for use of Beers List in elderly inpatients may be scant, we have no problem recommending its use in inpatients.
So dont hesitate to use some of our most important patient safety interventions, like medication reconciliation and CPOE, to reduce the risk of adverse events from Beers List drugs in the elderly hospitalized patient as well as the elderly outpatient.
Rothberg MB, Pekow PS, Liu F, Korc-Grodzicki B, Brennan MJ, Bellantonio S, Heelon M, Lindenauer PK. Potentially Inappropriate Medication Use in Hospitalized Elders. Journal of Hospital Medicine 2008; 3: 91-102 http://www3.interscience.wiley.com/journal/118860229/abstract
Joint Commission has published the new 2009 National Patient Safety Goals. There are several new additions and several modifications of previous NPSGs. Most are in keeping with the quality and patient safety focus being fostered by the new Medicare reimbursement policies regarding potentially preventable adverse outcomes or involve activities your organization may already be performing under such quality improvement collaboratives with IHI or SCIP (the surgical care improvement project). Hot topics are healthcare-associated infections, medication reconciliation, and safe site surgery.
Joint Commission has also redone the numbering scheme to make the format similar to that used for all the other Joint Commission standards. Our recommendation to Joint Commission: Add NPSG.02.02.01 to your list of Do Not Use Abbreviations! For an organization that stresses the important techniques we use in patient safety, such as simplification and improved communication, Joint Commission certainly doesnt practice what it preaches. It clearly needs to simplify its nomenclature and use descriptors that readily convey to all the nature of the standard under discussion.
Our railing about the less-than-useful nomenclature aside, these new and/or revised NPSGs make a lot of sense from both a patient safety and business perspective and your hospital should already be doing most of the required activities.
Some changes have been made to the Universal Protocol. Several elements present in the New York State Surgical and Invasive Procedure Protocol (NYSSIPP) are now in the Joint Commission Universal Protocol. That includes a separate timeout when more than one procedure is being performed on the patient. It also requires use of a checklist during the pre-procedure verification process. The checklist can be paper or electronic or even on a wall-mounted white board and needs to include elements such as the H&P, anesthesia assessment, completed informed consent, appropriate diagnostic and imaging reports or images, and any required implants, devices, special equipment or blood products that will be needed.
Weve long been advocates of using the surgical timeouts for far more than originally intended. In our April 9, 2007 Patient Safety Tip of the Week Make Your Surgical Timeouts More Useful we advocated using either the pre-surgical timeout and/or the final verification timeout to also focus on some of the more common complications you wish to avoid. For example, use the timeout to ask questions such as following:
Consider adding these questions to your checklist. And see our July 1, 2008 Patient Safety Tip of the Week WHOs New Surgical Safety Checklist.
And the Universal Protocol now clarifies issues regarding marking the procedure site. This applies to all procedures involving incision or percutaneous puncture or insertion. The updated goal/standard addresses who does the marking, method of marking, and additional requirements for verifying the site for spinal procedures.
The new NPSGs have a phase-in period where leadership has assigned responsibility for oversight and coordination by April 1, 2009, an implementation plan is in place by July 1, 2009, pilot testing is being done on at least one clinical unit by October 1, 2009, and full implementation across the hospital is done by January 1, 2010. They also have requirements for educating appropriate healthcare workers, patients and their families, conducts assessments and measurements, and reports the results and outcome measures to key stakeholders.
Three new NPSGs focus on prevention of nosocomial infections: healthcare-associated infections resulting from multiple drug-resistant organisms (MDROs) such as MRSA or VRE or C. diff infections, central line-associated bloodstream infections, and surgical site infections. Hospitals are expected to use evidence-based practices or best practices in their programs to prevent these potentially preventable infections. These include things like use of CDC guidelines for reducing transmission of MDROs, surveillance programs for MDROs based on risk assessment, laboratory-based alert system that identifies new patients with MDROs and systems to alert patients readmitted or transferred with MDROs. The central line-associated bloodstream infection (CLAB) standard applies to both central venous catheters and PICC lines. The evidence-based/best practices include use of checklists and protocols for line insertion, proper hand hygiene prior to insertion or manipulation, avoidance of femoral catheters where possible, standardized all-inclusive supply kits, standardized sterile barrier precautions, chlorhexidine-based antiseptic for skin preparation (for patients over 2 months of age) unless contraindicated, standardized protocols for disinfecting catheter hubs and injection ports before accessing the ports, and routine evaluation for continued necessity of catheters. And the surgical site infection standards focus on some of the SCIP recommendations such as use and timing of antimicrobial prophylaxis and their discontinuation, and use of clippers or depilatories (rather than shaving) in those cases where hair removal is appropriate.
We expect that the evidence-based interventions for preventing infections in all three categories are likely to be expanded by the time full implementation of these new NPSGs are required.
We spend a great deal of time in our infection control activities attending to the local patient environment, meaning their room and the personnel and equipment entering their room. But we also need to pay attention to some of the other areas in which transmission of infection is a potential threat. One such area is the radiology suite. Many of the patients at highest risk for transmission of nosocomial pathogens are also the likeliest to get high tech imaging studies in the radiology suite, such as CT or MRI scanning. Dr. Peter A. Rothschild has been running an excellent series on Preventing infection in MRI: Best practices for infection control in and around MRI suites on the radiology website AuntMinnie.com.
A new goal/standard was added to eliminate transfusion errors related to patient misidentification.
On the medication reconciliation side, Joint Commission has clarified some issues about medication reconciliation in those areas where medications are used minimally or prescribed for a short duration (such as ERs, urgent care, convenient care, office-based surgery, outpatient radiology, ambulatory care, and behavioral health care). Facilities are still required to obtain a list of all the medications a patient has been taking at home but are not required to know the dose, route, or frequency of use. Another new requirement is that facilities provide at discharge from the hospital a complete and current list of reconciled medications directly to the patient (and document this interaction). Lists of reconciled medications should also be sent to the primary care provider, next provider of care, and referring provider.
Requirements for patient education and active involvement in their care have been emphasized in standards on patient identification, anticoagulation, and prevention of infection. The anticoagulation standard has been clarified and does not apply to short-term prophylactic anticoagulation (eg. DVT prophylaxis) where laboratory coagulation parameters are not expected to be significantly outside the normal range.
Overall, the new NPSG are very reasonable standards and hopefully most of you are already in significant compliance with these because they make sense from multiple perspectives.
Update: See our March 2009 Whats New in the Patient Safety World column Joint Commission Puts a Hold on Medication Reconciliation Scoring.
Joint Commission. 2009 National Patient Safety Goals.
Joint Commission. Renumbering Scheme for National Patient Safety Goals.
Rothschild PA. Preventing infection in MRI: Best practices for infection control in and around MRI suites. Auntminnie.com 2008
WHO surgical safety checklist
AHRQ PSNet has introduced a series of patient safety primers. The following topics are covered:
They are, in fact, primers meaning they are very introductory works on several important areas related to patient safety. However, each has extensive links to both classic and contemporary bibliographic references and tools.
The primer on Computerized Physician Order Entry (CPOE) discusses the basic concepts of both CPOE and clinical decision support systems (CDSS) and provides data about the efficacy of CPOE and CDSS and the unintended consequences. Then it provides references (with links) to over 180 resources on CPOE/CDSS including journal articles, newspaper/magazine articles, books, and audiovisual tools.
The primer on Handoffs & Signouts provides background on the problematic issues with communication in healthcare and discusses structured signout techniques like SBAR and ANTICipate. Medication reconciliation is included as one of the critical areas prone to communication difficulties. The reference list of over 400 resources includes links to some of the classic literature on handoffs in other high-risk industries and includes topics like medication reconciliation, correct patient identification, followup of diagnostic testing results, and many more.
Medication Reconciliation also gets its own primer. Though the text of this primer is extremely brief, there are excellent links to toolkits and papers on technological solutions to this issue which continues to perplex us all.
Health Care-Associated Infections (HAIs) focuses on the four most common nosocomial infections: Central venous catheterrelated bloodstream infections (CRBSI), Surgical site infection (SSI), Ventilator-associated pneumonia (VAP), and Catheter-associated urinary tract infection (CAUTI). A simple table outlines the more common evidence-based interventions to help prevent these infections. There are good links to CDC guidelines on infection control and the great work by Peter Pronovost and Atul Gawande on use of checklists as a simple but powerful technique in infection prevention (not to mention the many other uses of checklists in patient safety).
Never Events is primarily a compilation of serious untoward patient consequences appearing in Joint Commissions Sentinel Events, or the Minnesota Department of Healths list of serious reportable events, and NQFs list of never events. But again good references.
Patient Disclosure is a good discussion about the relatively recent trend in healthcare to both disclose and apologize to patients and/or their families and loved ones when an adverse event occurs as the result of the healthcare process itself. It discusses the studies supporting disclosure/apology, including continued controversies, and has good references about how such is best done. It notes the position statements of patient safety organizations and specialty societies plus the legislation in many states on this issue.
Rapid Response Systems remain controversial since evidence of their efficacy remains unclear at this time. However, the concept of earlier identification of clinical deterioration in patients is a logical patient safety concept. This primer talks about IHIs role in bringing this issue to the table and Joint Commissions endorsement of the need for earlier response, criteria for activating rapid response teams, and the various models for rapid response teams. The primer is nonjudgemental and notes the pros and cons of rapid response teams. Most importantly, the references point you to the evidence you need to help you decide what your organization will do to foster earlier (preventive) interventions.
Root Cause Analysis is only a few paragraphs long but its value is in its very extensive list of references, guidelines and tools for performing RCAs.
If you are looking for one comprehensive chapter on any of these eight topics, you wont find them here. However, if you want to easily get to a comprehensive bibliography and list of tools and other resources related to these topics, you cant go wrong by visiting this site. AHRQ does a great job of putting the tools you need at your fingertips.
Update: See our February 2009 Whats New in the Patient Safety World column Some More New AHRQ Patient Safety Primers.
CMS has finalized its list of never events for which there will be no additional payments beginning in October 2008. The final rule was published in the August 19, 2008 edition of the Federal Register.
We previously discussed the upcoming changes in our August 21, 2007 Patient Safety Tip of the Week Costly Complications About To Become Costlier and January 22, 2008 Patient Safety Tip of the Week More on the Cost of Complications and April 22, 2008 Patient Safety Tip of the Week CMS Expanding List of No-Pay Hospital-Acquired Conditions. In the latter column we had speculated that not all of the proposed never events would make the final list. The final list contains even fewer than we had anticipated.
The first eight hospital-acquired conditions (HACs) were:
Of the nine newly proposed changes, only the following made the final list:
CMSs action thus brings to 11 the number of never events for which it will not make additional payments beginning next month. The final rule also contains a list of other never events which will be considered for addition to the list in future years.
CMS has also contacted state Medicaid directors and provided information about how states can adopt the same never events practices. The letter specifically encourages states to adopt the same nonpayment policies outlined in the final rule. Many states already have developed their own plans to eliminate payment for some never events. Some, such as New York, have developed even more extensive lists of events that will no longer be paid for. Private insurers are often following suit as well.
It thus behooves all organizations to ensure they have appropriate patient safety/quality improvement programs in place to minimize the risk of these complications. CFOs have traditionally focused much more on the revenue side of the balance sheet than the cost avoidance side. Justifying patient safety initiatives to CFOs should no longer be difficult when you put together a spreadsheet with the number of occurrences of the above events at your facility. And the list will grow in future years.
Update: See also our December 2008 Whats New in the Patient Safety World column CMS Plans to Stop Payment for Wrong-Site Surgery.
This month we look at a number of items in the news that are follow-ups to columns we have previously published.
In our July 8, 2008 Patient Safety Tip of the Week Medical Helicopter Crashes we discussed the epidemic of crashes of helicopters and other medical rescue aircraft in the recent past. Since that column there have been two more medical helicopter crashes. In August a small plane on a medical mercy mission crashed in Easton, Massachusetts, killing a cancer patient and his wife plus the pilot. The plane was flying the cancer patient from Long Island to the Dana Farber Cancer Institute in Boston. Then last weekend a medical helicopter crashed in Maryland, resulting in four more deaths. Details about the former crash are not available at this time but the Maryland crash apparently occurred in foggy weather. In our previous column we noted medical helicopter flights are often riskier because of conditions such as night flying and inclement weather, both of which were present for the Maryland crash. We also talked about Dr. Bryan Bledsoes work that had questioned how many medical helicopter flights were truly indicated. Details about the Maryland crash are sketchy but apparently the planned trip was to a hospital only 25 miles away. A recent state audit of Marylands MedEvac helicopters, which are run by the Maryland State Police, had also uncovered a number of issues and questions.
It is very difficult to second guess the people on the ground (or at the helicopter control site or the regional emergency response center) who have to make on-the-spot decisions about appropriate triage of accident victims. However, each such incident should have a post-event analysis that includes an assessment as to whether the type of transportation used was the most appropriate one. We would expect that ultimately a checklist of a short series of questions (eg. What is the distance to the trauma center? What is the anticipated drive time? What are traffic conditions like at this time? What are the weather conditions like at this time? What is the condition of the accident victim(s)? etc.) would probably help the on-site and emergency response personnel quickly make a good decision about the type of transportation most appropriate for the situation.
Our February 26, 2008 Patient Safety Tip of the Week Nightmares.The Hospital at Night mentioned one of the presentations at IHIs Annual National Forum on Quality Improvement this past December The Hospital at Night Program: Reducing Risks at Our Most Vulnerable Time of the Day by David Gozzard and Carol Haraden. This described a redesign of hospital structure and processes in anticipation of a significant limitation of work hours imposed by the European Union (the European Working Time Directive). As part of the redesign they collected data on the tasks performed off-hours and found that many tasks performed by doctors at night could be redistributed to nonmedical staff and that many tasks could be performed during daytime hours. For instance, leaving space in the OR schedule for emergencies reduced delays in regularly scheduled cases and reduced the likelihood of doing overflow cases at night. They also focused on communication and handoffs and made greater use of SBAR and written reports that were discussed verbally. And they made better use of the MEWS (Modified Early Warning System) to identify patients at risk of deterioration. Preliminary, largely anecdotal, experiences with the program have been positive.
We said it would be most interesting to see the effect of this program on hard outcome measures. Well, the first report of outcomes of this project are available at the Hospital at Night project website. Outcomes to date have been modest. It does appear that implementation has reduced the number of deaths within 2 days of admission and the number of deaths within 2 days of surgery/procedure. And it did result in the need for fewer transfers externally to other hospitals. And there were some modest improvements in productivity and efficiency measures such as number of hospital beds and average length of stay. While the improvements to date are not eye-popping, we like the concept behind this program and hope that future outcome measurements will demonstrate the effort is worthwhile.
In our July 2008 "Whats New in the Patient Safety World" column we mentioned the issue of nosocomial infection spread via the radiology department. We noted Dr. Peter A. Rothschild had been running an excellent series on Preventing infection in MRI: Best practices for infection control in and around MRI suites on the radiology website AuntMinnie.com. That full paper is now available at a commercial website with eleven suggestions for infection control procedures for imaging centers and departments. Also available at that website is a short You Tube video clip. Were somewhat bothered by the use of this paper in what appears to be a commercial venture marketing pads for MRIs. Nevertheless, the paper is one we find quite useful in pointing out some of the hazards of the MRI/radiology suite.
The Alabama Hospital Association has announced its plan for member hospitals to use standardized color-coded wristbands starting January 1. Yellow will signify the patient is at risk for falls, red an allergy, and purple DNR. More than 20 states have now standardized on these three colors for wrist bands.
The American Hospital Association is now leading the charge to get all hospitals standardized on these colors. See the AHA Quality Advisory on Implementing Standardized Colors for Patient Alert Wristbands for advice on implementing, education and risk reduction strategies. Their materials include a state-by-state list of state hospital association efforts to standardize wristband colors.
The Joint Commission has released a new Sentinel Event Alert Preventing errors relating to commonly used anticoagulants This alert summarizes the sentinel events in the Joint Commission Sentinel Event Database related to anticoagulation and provides excellent discussion on contributing factors and risk reduction strategies.
Those of you who have been reading our columns for the past year have seen multiple discussions on the hazards of anticoagulation including Patient Safety Tips of the Week:
August 19, 2008 Arterial Line Issues
July 29, 2008
July 22, 2008
July 15, 2008
July 17, 2007
And also the following Whats New in the Patient Safety World columns:
Two great new resources on preventing surgical site infections (SSIs) became available last month. NICE (the UKs National Institute for Health and Clinical Excellence) released its guidance on surgical site infections. The guidance includes a summary guideline, a quick reference, and a much larger guideline, plus evidence tables and other resources.
The second resource is a supplement to the October issue of Infection Control & Hospital Epidemiology. The entire supplement consists of A Compendium of Strategies to Prevent Healthcare-Associated Infections in Acute Care Hospitals and is available free online. This resource includes articles on strategies to prevent central line-associated bloodstream infections, ventilator-associated pneumonia, catheter-associated urinary tract infections, preventing MRSA and C. difficile infections, plus the article on preventing surgical site infections. All the recommendations were sponsored and authored by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA), partnering with Association for Professionals in Infection Control and Epidemiology (APIC), the Joint Commission, and the American Hospital Association (AHA). Youll find each of the individual articles to be comprehensive and useful or you can read the summary article, which includes the key recommended practices for all of the HAIs.
The compendium article summarizes the statistics on SSIs. SSIs occur in 2-5% of surgical procedures and their occurrence greatly increases patient morbidity and mortality, length of stay, and resource consumption. The risk of death is 2-11 times higher in patients with SSIs and in about three-quarters of those who die, death is attributable to the SSI. SSIs add 7-10 days of hospital stay and $3000 to $29,000 additional cost.
The compendium article does a nice job of describing the methods for detection of SSIs, including use of automated data systems to expand surveillance. It also discusses the need for post-discharge surveillance.
The compendium article includes a table with risk factors for SSIs, both intrinsic and extrinsic, and their associated grades of evidence. Many of the interventions to prevent SSIs are familiar to most of you through the SCIP (Surgical Care Improvement Project).
Good surgical care begins well before the surgery. The patient (and family or caregivers where appropriate) should be informed about the risks of infection and what will be done to reduce those risks as part of the informed consent process. Good control of diabetes reduces the SSI risk. Smoking increases the SSI risk so smoking cessation should be encouraged well prior to surgery.
The NICE guideline notes the patient should bathe or shower with soap on the day of or day before the surgery. The usefulness of preoperative bathing with chlorhexidine-containing solutions remains an unresolved issue. Hair removal is no longer routinely recommended. For those operations where hair must be removed for surgical access, it should be removed with electric clippers on the day of the surgery, with clippers having a single-use removable head. Razors should not be used (they actually increase the risk of infection). The compendium guideline also allows use of depilatory preparations.
The full NICE guideline provides a summary of the procedures for which prophylactic antibiotics have been shown to be effective in reducing SSIs and the associated evidence base. The timing of antibiotic prophylaxis in those cases where antibiotics are indicated is crucial. The SCIP project uses the target within one hour prior to surgical incision, though the period is extended to 2 hours for antibiotics such as vancomycin and fluoroquinolones to allow for maximum tissue availability during surgery. Note that vancomycin is not an antibiotic routinely used in prophylaxis but may be used under special circumstances. The compendium recommendation also notes that the dosing of the prophylactic antibiotic may need to be increased in morbidly obese patients. Limiting duration of prophylactic antibiotics is important to reduce the emergence of antibiotic resistance and to prevent C. difficile infections. Prophylactic antibiotics should be discontinued within 24 hours of surgery (48 hours for cardiac surgery). The NICE guideline differs in that it recommends considering a single dose of prophylactic antibiotic be given on starting anesthesia, with subsequent doses determined by the operating time and the pharmacokinetics of the antibiotic. While the single dose approach may be more cost-effective, it should be noted that the evidence for single-dose vs. 24 hour dosing is still limited.
Prophylactic antibiotics should be an item on your surgical safety cheklist (see our July 1, 2008 Patient Safety Tip of the Week WHOs New Surgical Safety Checklist).
Both guidelines discuss many of the procedures related to the immediate operative period, including surgical scrub (staff hand cleansing/decontamination), use of gowns and gloves and masks, antiseptic skin preparation, etc. The NICE guideline also addresses many postoperative procedures such as dressing changes and also provides many do not do things for wound care. The NICE guideline has one major difference from the US guidelines: hospital staff should remove hand jewelry, artificial nails, and nail polish before operations. The NICE guideline also cautions that there be sufficient time for evaporation of skin antiseptics and avoiding pooling of alcohol-based preparations (see our Patient Safety Tip of the Week for December 4, 2007 Surgical Fires and April 29, 2008 ASA Practice Advisory on Operating Room Fires).
Neither the NICE nor the compendium guidelines have specific recommendations regarding duration of surgery. Work with the National Nosocomial Infections Surveillance system risk index had shown that the incidence of SSIs increases when the procedure duration exceeds the 75th percentile for the duration for that type of procedure. Though some of that may be simply explained by very complex procedures requiring more time, minimizing duration should be encouraged when possible. Yet we know of few hospitals that actually track procedure duration in real-time. And adding time pressure to a procedure might conceivably increase the likelihood of other intraoperative errors that might be detrimental to the patient. Nevertheless, since there are a limited number of operative risk factors that are amenable to change, tracking operative time might be useful in some circumstances (eg. in a teaching hospital where duration may be extended because of the educational aspects). A recent study of SSIs (Campbell 2008) did show that hospitals that were high outliers for SSIs had higher trainee-to-bed ratios and the operations took significantly longer.
The compendium article discusses the infrastructure needs and the importance of education (staff, patients, family) and especially a system for feedback about SSI rates to be used in quality improvement activities.
Both the NICE and the compendium guidelines also do a good job of discussing issues that are yet unresolved (eg. role of routine MRSA screening or decolonization, role of preoperative bathing with chlorhexidine-containing solutions, etc.) and those shown not to be helpful (eg. delaying surgery to give parenteral nutrition) and areas for further research (eg. role of tissue oxygenation).
Lastly, the compendium article discusses the performance measures that your facility should be using to monitor SSIs and your preventive measures.
Long gone are the days when we thought that SSIs were part of doing business. It is clear that 40-60% of SSIs are preventable (IHI 5 Million Lives Campaign). Preventing them helps your patients, your staff morale, your standing in the community, and your bottom line.
Update: See our December 2008 Whats New in the Patient Safety World column More on Preventing Surgical Site Infections (SSIs)
NICE guidance on surgical site infections
Hospital Acquired Infections Compendium. In supplement to October issue of Infection Control & Hospital Epidemiology 2008; 29: 901-994
Campbell DA, Henderson WG, Englesbe MJ, Hall BL, OReilly M, Bratzler D, Dellinger EP, et al. Surgical Site Infection Prevention: The Importance of Operative Duration and Blood TransfusionResults of the First American College of Surgeons/National Surgical Quality Improvement Program Best Practices Initiative. Journal of the American College of Surgeons 2008; published online 10 October 2008.
Last month (November 2008 Whats New in the Patient Safety World Preventing Surgical Site Infections: New Resources) we noted some of the evidence-based recommendations for preventing surgical site infections (SSIs). A couple of the recommendations that have been based on less rigorous evidence, smoking cessation and avoidance of hyperglycemia, have just received more backing in studies just published.
Lindstrom and colleagues (Lindstrom 2008) reported the results of a randomized controlled trial on the impact of smoking cessation begun within 4 weeks of elective surgery on surgical complication rates. The found almost a 50% reduction in total complication rate for patients in the intervention (smoking cessation) arm. The study, however, was limited by its small size (they had difficulty recruiting patients who might be randomized to the smoking cessation arm). Looking at just SSIs, though fewer wound infections occurred in the intervention group, the numbers were far too small to meet statistical significance. Nevertheless, the study is important in lending weight to smoking cessation preoperatively. Whereas most prior studies that showed a benefit on postoperative complications began smoking cessation 6-8 weeks prior to surgery, this study demonstrates that there is a benefit even when smoking cessation is begun as late as 4 weeks prior to elective surgery.
Ramos and colleagues (Ramos 2008) published a study strengthening the correlation between perioperative hyperglycemia and postoperative infections (including SSIs), independent of preoperative blood glucose level or diabetic status. Using data from a risk-adjusted outcomes database from the National Surgical Quality Improvement Project, they showed that for each 40 mg/dl increase in serum glucose the risk of postoperative infection rose 30%. Postoperative hyperglycemia also had a significant adverse effect on length of stay. Caution: this was not a randomized controlled trial to show that treatment to avoid perioperative hyperglycemia results in fewer SSIs or better outcomes but it further strengthens the association between hyperglycemia and postoperative infections.
Together, these two studies strengthen the evidence for those two interventions in the guidelines for preventing SSIs that we talked about last month.
Ramos M, Khalpey Z, Lipsitz S, Steinberg J, Panizales MT, Zinner M, Rogers SO. Relationship of Perioperative Hyperglycemia and Postoperative Infections in Patients Who Undergo General and Vascular Surgery. Ann Surg 2008; 248(4):585-591
Lindstrom D, Azodi OS, Wladis A, Tonnesen H, Linder S, Nasell H, Ponzer S, Adami J. Effects of a Perioperative Smoking Cessation Intervention on Postoperative Complications: A Randomized Trial. Annals of Surgery. 2008; 248(5):739-745 http://www.annalsofsurgery.com/pt/re/annos/abstract.00000658-200811000-00008.htm;jsessionid=J2LL93fxpLQhQMXlrBMyG85SWpcX3xy1s3LPbxj5bF6S49HWfGhQ!976670012!181195629!8091!-1
CMS has posted on its website its proposed decision memos to withhold payment for wrong surgery performed on a patient, surgery on the wrong body part, and surgery on the wrong patient. Quite frankly, we were surprised to hear that CMS had no prior payment decision on such cases. Note that these were not part of the recent final decision on no-pay for never events (See our October 2008 Whats New in the Patient Safety World CMSs Final Rule on Non-Payment for Never Events) The proposals are open for comment, with 1/31/2009 as the proposed date for final decision.
Update: these decisions have become finalized (See February 2009 Whats New in the Patient Safety World CMS Plan to Stop Payment for Wrong-Site Surgery Final).
The Institute of Medicine (IOM) has released its new report Resident Duty Hours: Enhancing Sleep, Supervision, and Safety this month. Though the report does not recommend further constriction of the current limit of 80 hours per week for residents, it does include recommendations about further reducing consecutive hours worked and inclusion of mandatory nap periods and mandatory days off. Moreover, it recommends that much of the work that residents currently peform (scut work) such as phlebotomy be done instead by other healthcare workers. It also calls for better supervision of residents and increased resident education in patient safety.
One important point has to do with handoffs (see our September 30, 2008 Patient Safety Tip of the Week Hot Topic: Handoffs and see the article just below this one). With more restricted workhours, the number of handoffs between residents has increased. The IOM report emphasizes the need to make adequate time available for handoffs to occur.
In September we did our Tip of the Week on Hot Topic: Handoffs, citing great work done primarily by residents and other housestaff to improve on the handoff process. Now surgical residents at Johns Hopkins (Kemp 2008) have, based on their experiences with inadequate handoffs, put together their Top 10 List for a Safe and Effective Sign-out. They stressed providing adequate time and appropriate quiet environment for sign-outs, emphasizing the need for sign-out to be an active 2-way interaction. They want a standardized list/format, including items that are important to surgical patients. Prioritizing the patients (knowing which patients are the sickest and seeing them first) was important, as was knowing who the senior resident on-call was. The sign-out should include outstanding tasks, outstanding lab/radiology studies, outstanding consults, and details about any pending admissions. Morning sign-out is just as important as evening sign-out and adequate time should be provided for this as well.
They have included this list and process in their intern orientation. They even include a simulation sign-out as part of that orientation. They also discuss the utility of web-based patient sign-out lists but note that the sign-out lists, whether paper or electronic, should be destroyed after the on-call period to preserve patient confidentiality.
Kemp CD, Bath JM, Berger J, Bergsman A, Ellison T, Emery K, Garonzik-Wang J, Hui-Chou HG, Mayo SC, Serrano OK, Shridharani S, Zuberi K, Lipsett PA, Freischlag JA. The Top 10 List for a Safe and Effective Sign-out. Arch Surg. 2008;143(10):1008-1010
We first talked about Rapid Response Teams in our August 2007 Whats New in the Patient Safety World column Responding to Patients with Clinical Deterioration. Then, in our Novermber 27, 2007 Patient Safety Tip of the Week More on Rapid Response Teams we discussed the weakness of the evidence supporting a positive effect of rapid response teams on patient outcomes and discussed many of the methodological problems in studies on RRTs.
Chan and colleagues (Chan 2008) have just published a prospective cohort design study comparing code rates and mortality before and after implementation of rapid response teams for adult inpatients. Raw code rates per 1000 admissions were lower in the the post-RRT period. However, after adjustment for a number of variables, overall hospital codes rates were not significantly reduced, though those for non-ICU patients were reduced. Furthermore, mortality was not significantly better after implementation of the RRT program. A significant finding in their study is that a large percentage of patients who died after RRT intervention either had DNR status or were accorded DNR status during or after the RRT intervention.
The study did not include financial data. However, in addition to the costs of developing and staffing the RRTs, it should be noted that a substantial number of patients were bumped up to a higher level of care (usually ICU or telemetry service) after RRT intervention, thus adding to overall costs without significantly affecting outcomes (at least in terms of mortality).
All this negative evidence does not negate the logic of having a culture of safety that helps recognize early patients that are in need of rescue. But it does raise many questions about committing many resources to develop RRTs without better evidence-based validation of the RRT concept. The idea remains a sound one but the most appropriate targets, the triggers, the makeup of teams, the mode of response, the logistics, and the best outcome measures all need to be validated before hospitals rush willy-nilly into developing RRTs.
Chan PS, Khalid A, Longmore LS, Berg; RA, Kosiborod M, Spertus JA. Hospital-wide Code Rates and Mortality Before and After Implementation of a Rapid Response Team. JAMA. 2008; 300(21):2506-2513
A paper presented at this months Radiological Society of North Americas annual meeting showed that inclusion of photographs of patients improved accuracy of radiologists reports, according to a press release from the RSNA. 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.
This somewhat unexpected finding adds another reason to consider adding patient photographs to electronic medical records (EMRs). We think that inclusion of a patient photograph could significantly improve patient safety (eg. helping prevent a physician from inadvertently ordering on the wrong patient during CPOE, or a nurse administering a medication to wrong patient). In the digital age, it is certainly easy enough to include photographs in the EMR. But the logisitics, legal and privacy issues, measurable outcomes, and unintended consequences remain to be determined.
In our September 2, 2008 Patient Safety Tip of the Week Updates on VAP Prevention we discussed the recent NICE evidence-based guidance on technical patient safety solutions for prevention of ventilator-associated pneumonia. In that they noted that evidence suggests that selective decontamination of the digestive tract (SDD) using topical antibiotics may reduce the incidence of ventilator-associated pneumonia (VAP) and also reduce mortality. However, concerns about the risk of infection with Clostridium difficile and the induction and/or selection of resistant, including multiresistant, microorganisms as a result of SDD kept them from recommending this.
Now a new study from the Netherlands (de Smet et al 2009) published in the New England Journal of Medicine suggests that overall ICU mortality can be reduced by selective decontamination of the digestive tract (SDD) or by selective oropharyngeal decontamination (SOD) without emergence of antibiotic resistance or increase in C. diff infections. This study was not about preventing just VAP but rather preventing all ICU infectious complications and improving mortality. Eligibility for the trial required expected duration of intubation of more than 48 hours or expected ICU length of stay of more than 72 hours. Patients in the SDD group also received 4 days of systemic antibiotics (intravenous cefotaxime)in addition to topical application of tobramycin, colistin, and amphotericinB in the oropharynx and stomach. SOD consisted of oropharyngeal application of the same pasteused for SDD. Both groups were compared to a group receiving standard treatment. Also, in the SDD group only, systemic antibiotics with antianaerobic activity were discouraged.
The study utilized a cluster methodology in which all 3 study regimens were administered in each ICU over the course of 6 months, with the order being randomly assigned. The randomization procedure was scientifically sound but there were differences in baseline characteristics of the patients (with patients in the standard care group being younger, having lower APACHE II scores, less likely to be mechanically ventilated, and more likely to be admitted for surgical reasons).
The primary outcome measure was mortality at Day 28. In a random-effects logistic regression model adjusted for multiple covariates, the odds ratios for death at Day 28 compared to standard treatment were 0.83 for SDD and 0.86 for SOD, both statistically significant. The respective absolute risk reductions were 3.5% for SDD and 2.9% for SOD (respective numbers needed to treat = 29 and 34). Trends toward improvement in secondary outcomes such as ICU and total LOS, and time on ventilator in the SDD and SOD groups did not reach statistical significance. Median number of systemic antibiotic doses did not differ significantly among the three groups. Importantly, surveillance revealed no increase in antibiotic resistance nor increase in C. diff prevalence during the study period. Both SDD and SOD were low-cost (SOD costing about $1 per day and SDD about $12 per day).
But there are numerous issues with this study. Most importantly, benefit in the primary outcome measure was seen only after adjustment for covariates. The study analysis plan had to be changed from its original plan. The investigators had intended to use in-hospital mortality as the primary outcome measure. However, for a variety of theoretical statistical reasons that apply to cluster-randomization trials, the plan was changed and called for the Day 28 mortality as the primary outcome measure and use of the random effects model to account for effect of covariates. Also, as mentioned previously, the randomization procedure did not result in study groups with similar baseline characteristics. The study was also not blinded (the treating physicians and investigators were aware of the treatment group randomization).
So what are the take-home lessons here? Perhaps the best lesson is that the SOD group had essentially as good outcomes as the SDD group. The authors themselves note that this may also mean that oropharyngeal decontamination with agents such as chlorhexidine might be a potential alternative approach.
While the findings of this study are exciting, we remain conservative in endorsing their conclusions. Wed like to see another study confirm that one of these interventions (SOD would be the obvious one to choose) reduces mortality in ICU populations elsewhere. Hopefully that study will avoid some of the methodological problems and issues encountered in the current study.
This is particularly important since some other new studies are demonstrating that some rather simple interventions may be effective in preventing VAP. An article in Nursing Times cites a research study to be published soon in the Journal of Intensive Care Medicine showing that teeth cleaning in ventilated patients cuts the rate of VAP in half. Twice daily brushing for one minute, followed by application of mouthwash, cut the VAP rate from 5.2% to 2.4%, an improvement that was sustained over time. However, we are awaiting publication of that study to see whether the more important clinical parameters improved. In our November 11, 2008 Patient Safety Tip of the Week Probiotics and VAP Prevention we had mentioned that oral decontamination with chlorhexidine (CHX) has been shown to prevent VAP (Chlebick 2007) but does not reduce the time on the ventilator, the length of stay (LOS) in the ICU or rates of mortality (Chan 2007). The incidence of VAP and other ICU infections is of interest but the more important clinical outcomes are outcomes like mortality, time on the ventilator, ICU and hospital LOS, and costs.
Update: The article referenced above has now been published in the Journal of Intensive Care Medicine (Sona 2009). Their protocol consisted of brushing thepatients' teeth with toothpaste, rinsing with tap water, and subsequent application ofa 0.12% chlorhexidine gluconate chemical solution done twicedaily at 12-hour intervals. Their VAP rate fell from 5.2 cases per 1000 ventilator days to 2.4 cases per 1000 ventilator days after institution of the protocol, a 46% reduction. The intervention was very low cost and nursing compliance with the protocol was over 80%. They did not actually measure savings but estimate that the 14 VAP cases prevented in one year would have saved $140,000 to $560,000 based on the literature estimates that VAP cases cost $10,000 to $40,000 per case.
NICE. PSG002 Technical patient safety solutions for prevention of ventilator-associated pneumonia in adults: guidance. 27 August 2008 http://www.nice.org.uk/nicemedia/pdf/PSG002Guidance.pdf
de Smet AMGA, Kluytmans JAJW, Cooper BS, et al. Decontamination of the Digestive Tract and Oropharynx in ICU Patients. New England Journal of Medicine 2009; 360(1):20-31, January 1, 2009
Ford S. Pneumonia rates in ICU can be halved by cleaning teeth. Nursing Times. December16, 2008
Chlebick MP, Safdar N: Topical chlorhexidine for prevention of ventilator-associated
pneumonia: A meta-analysis. Crit Care Med 2007, 35:595602 http://www.ccmjournal.com/pt/re/ccm/abstract.00003246-200702000-00037.htm;jsessionid=JYzZFqbp77jdqFqLrhwhZ1cbDLbnBwLvyYMRxvhTwWK48kjGpw9B!-1031399950!181195629!8091!-1?index=1&database=ppvovft&results=1&count=10&searchid=2&nav=search
Chan EY, Ruest A, O Meade M and Cook DJ: Oral decontamination for prevention of
systematic review and meta-analysis pneumonia in mechanically ventilated adults.
Sona CS, Zack JE, Schallom ME, McSweeney M, McMullen K, Thomas J, Coopersmith CM, Boyle WA, Buchman TG, Mazuski JE, Schuerer DJE.The Impact of a Simple, Low-cost Oral Care Protocol on Ventilator-associated Pneumonia Rates in a Surgical Intensive Care Unit. J Intensive Care Med 2009 24: 54-62
Seems weve heard a lot lately about the unintended consequences of healthcare IT. Just look at some of our recent Patient Safety Tip of the Week columns:
Fortunately, there is also good news! A study in last weeks Archives of Internal Medicine (Amarasingham 2009) demonstrated a strong association between implementation of health information technologies and reductions in mortality rates, complications, and costs. Using a tool developed to measure hospitals level of implementation of various healthcare IT tools, the authors found that for every 10-point increase in the automation of notes and records there was an associated 15% decrease in mortality. Also, higher scores for implementation of clinical decision support were associated with a 16% decrease in complications. And progressively lower costs were seen for admissions if a hospital had implemented automated test results, order entry, and decision support.
Since this was not a randomized controlled trial, the study does not prove that the healthcare IT initiatives, per se, were the cause of the positive outcomes. Hospitals that have implemented HIT tend to be ones that have more of a culture of safety and it may be the latter that is more responsible for the good outcomes. Nevertheless, this study lends credence to our position that healthcare IT is a critical component for improving patient safety and may lead to substantial cost savings as well. Of note, HealthGrades also happened to release it top hospital report last week and it noted that the top 5% of hospitals had a 27% lower mortality than other hospitals. Many of these hospitals are heavily computerized.
On the down side, a series of software glitches in the VA system (see Yen 2009) nationally resulted in many patients receiving unnecessary and potentially dangerous doses of medications like heparin. This apparently began when the VA did its annual software upgrade in August. Numerous instances of medical data popping up under another patients name were noted, as were instances where discontinued medications continued to be administered. This example, of course, shows one of the potentially dangerous unintended consequences of healthcare IT is having a single error (such as a software coding error) result in harm to multiple patients.
Amarasingham R, Plantinga L, Marie Diener-West M, Gaskin DJ, Neil R. Powe NR. Clinical Information Technologies and Inpatient Outcomes
A Multiple Hospital Study. Arch Intern Med2009;169(2):108-114
HealthGrades press release
Yen H. Veterans exposed to incorrect drug doses. Associated Press January 14, 2009
Speaking of unintended consequences, a new study questions the cost-effectiveness of using a widely used formula to estimate patients glomerular filtration rate (eGFR). Use of the eGFR can identify patients with chronic kidney disease (CKD) who would not have been identified by simply looking at creatinine levels. Here in Western New York, we actually pioneered community-wide use of the eGFR to promote earlier identification of CKD (see Boissonault 2003). The new study (Sydney et al 2009) appears in the Clinical Journal of the American Society of Nephrology. It confirms the positive outcomes of using eGFR (identifying CKD earlier, preventing some deaths and progression to ESRD). However, it also notes the potential impact of false negative test results (identifying some incorrectly as having CKD). Those patients often undergo further testing that may not have been necessary. The final answer on the widespread use of estimated GFRs will await further population-based studies. But this, again, is a great example of how you must always be vigilant for unintended consequences any time you introduce an intervention you expect to have positive outcomes.
Boissonnault, BA. Chronic kidney disease project in Buffalo N.Y.: A community-wide approach identifying, education and treating CKD patients. Dialysis Times, 9:5:23, 7, 2003
Sydney C.W. Tang, Bing L, Andrew S.H. Lai, Clara B.Y. Pang, Wai Kuen Tso, Pek Lan Khong, Mary Ip, Kar Neng Lai. The costs and benefits of automatic estimated glomerular filtration rate reporting. Clinical Journal of the American Society of Nephrology (CJASN) 2009 4(2): February 1, 2009
In December 2008 we told you that CMS Plans to Stop Payment for Wrong-Site Surgery. As expected, those proposals have now become final and CMS has posted on its website its final decision memos to withhold payment for wrong surgery performed on a patient, surgery on the wrong body part, and surgery on the wrong patient.
Wrong Surgery Performed on a Patient (CAG-00401N)
Surgery on the Wrong Body Part (CAG-00402N)
Surgery on the Wrong Patient (CAG-00403N)
As we noted previously they are, in fact, primers meaning they are very introductory works on several important areas related to patient safety. However, each has extensive links to both classic and contemporary bibliographic references and tools. The new ones are no different and are equally useful resources.
The primer on Safety Culture begins with the key characteristics seen in other high-reliability organizations (acknowledgement of hi-risk activities, determination to achieve consistently safe operations, blame-free environment, encouragement of collaboration across ranks and disciplines, and organizational commitment to safety). They go on to discuss enablers and barriers to a culture of safety and many of the tools we often discuss to improve safety (teamwork and communication, patient safety walk rounds, culture measurement tools, etc.). They stress the concept of just culture and avoiding hierarchical structures that may impede patient safety progress. Once again, a real strength of the primer is its links to other patient safety tools and a very useful bibliography.
The primer on Adverse Events after Hospital Discharge stresses that 20% of patients discharged from the hospital will suffer an adverse event, most of which were preventable. They focus on various failed communication opportunities and discontinuities in care. They stress the importance of discharge planning, medication reconciliation, followup on pending tests, and attention to health literacy issues. Good discussion of our favorite tools, checklists and structured communication tools, as cornerstones. And the links and bibliography are what youve come to expect of these fine AHRQ primers.
The primer on Teamwork Training focuses on crew resource management and lessons from the realm of human factors. As youd expect, there is a huge emphasis on TeamSTEPPS (see our Our May 22, 2007 Patient Safety Tip of the Week More on TeamSTEPPS), SBAR, handoffs, debriefing, and other tools.
The entire collection of patient safety primers is an extremely useful resource not only for those new to the patient safety movement but even for experienced patient safety and quality improvement personnel.
AHRQ Patient Safety Primers (home page)
AHRQ Patient Safety Primer Safety Culture
AHRQ Patient Safety Primer Adverse Events after Hospital Discharge
AHRQ Patient Safety Primer Teamwork Training
Our December 30, 2008 Patient Safety Tip of the Week Unintended Consequences: Is Medication Reconciliation Next? discussed the difficulties healthcare organizations are encountering in implementation of medication reconciliation programs. Well, Joint Commission must have been listening because shortly thereafter they announced that, effective January 1, 2009, they will temporarily halt inclusion of NPSG #8 (medication reconciliation) in the accreditation decision. They will still survey your organizations activities on medication reconciliation but there will be no requirements for improvement (RFIs) issued.
Joint Commission remains committed to the concept of medication reconciliation and will gather evidence on best practices and conduct meetings with stakeholders over the next year with the intent of reinstituting NPSG#8 in 2010. As before, weve been very concerned about unintended consequences occurring as a result of hasty implementation of unproven medication reconciliation techniques. We commend Joint Commission for being both practical and considerate in this decision.
Joint Commission. Medication reconciliation National Patient Safety Goal to be reviewed, refined. February 5, 2009
ECRI Institute, which participated in the root cause analysis of the Minnesota bassinet fire, has issued an important equipment alert. This alert lists the manufacturers and model numbers of infant radiant warmers that have heater elements which ECRI feels have an increased risk of precipitating fires. Your facility needs to determine whether any such units are in use and remove them.
Youll recall the unfortunate incident at Mercy Hospital in Coon Rapids, Minnesota of in which a neonate suffered burns in a flash fire while in an open-topped bassinette under a warmer while using an oxygen hood (see our January 29, 2008 Patient Safety Tip of the Week Thoughts on the Recent Neonatal Nursery Fire and our April 2008 Whats New in the Patient Safety World column More Neonatal Incubator Fires). Though nurses promptly extinguished the flames, the infant suffered burns over about 18% of his head and body.
Since that time there have been even more neonatal injuries and fatalities related to incubator fires in India.
Not only do you need to make sure you are no longer using one of the bassinet warming devices in the ECRI alert, but wed suggest your organization consider performing a FMEA (failure mode and effects analysis) on potential neonatal unit fires. We had hoped by now wed have several root cause analyses available to provide valuable lessons learned on these neonatal unit fires. However, details have not been published on any of the Indian cases. The executive summary of the Coons Rapids fire investigation is available and is a great place for you to start since it nicely outlines multiple theoretical concerns that you should be addressing. Focus, of course, is on all the components of the fire triad: an oxydizer, a heat source, and a fuel. That summary identifies the multiple potential heat sources you need to consider that could trigger a fire in an oxygen-rich environment. And, as we had expected in our previous columns, it does address potential fuels such as the alcohol-based disinfectants that we use so commonly now in our hospitals. The executive summary of the Minnesota incident does not go into much detail about oxygen but we have previously recommended that hospitals take a careful look to ensure that the clinical indications for use of oxygen are carefully adhered to. Just as in our discussions about the unnecessary use of urinary catheters, undoubtedly there are circumstances where neonates or other patients are reflexly begun on oxygen. (Worse yet, we know that reimbursement policies sometimes have the unintended consequence of unnecessarily prolonging oxygen therapy in neonates). Hospitals should have evidence-based criteria not only for starting oxygen therapy but also for its continuation and discontinuation.
Just as we need to ensure that everyone who enters an operating room has had appropriate training in surgical fire risk and procedures, we now need to consider similar training of everyone for any area in which oxygen is being used. This obviously would include not only staff, but everyone who might enter that area. That would include housestaff, agency personnel, and even parents and other visitors.
ECRI Institute High Priority Medical Device Alert
Infant Radiant Warmer Fire Prompts ECRI Institute Recommendations for Replacement.
Kanwar S. Concern focuses on patient safety. The Times of India. February 1, 2009
Allina Hospitals & Clinics. January 15, 2009
Surgical Team Training
Many of our columns have discussed teamwork, crew/cockpit resource management (CRM), communication, and handoffs. We are big advocates of the TeamSTEPPS program for teamwork training (see our our May 22, 2007 Patient Safety Tip of the Week More on TeamSTEPPS). One of the problems we encounter in planning and implementing such team training programs, however, is measuring success of such programs. Many of the benefits of such teamwork training help the team function much better in emergency circumstances or in preventing unwanted events that are very rare to start with (eg. wrong site surgeries). So such events are likely to be absent in both pre- and post-intervention studies. Metrics of operating room efficiency can be used. But most assessments need to rely on process measures that are fairly labor-intensive to collect.
We previously noted a study by Lingard et al (Lingard 2008) that used a checklist to structure short team briefings and documented reduction in the number of communication failures.
A new study by Havlerson et al. from Northwestern Memorial Hospital (Halverson et al 2009) attempts to demonstrate the benefits of an intensive crew resource management training for all surgeons, anesthesiologists, OR nursing and ancillary personnel. The curriculum included a 4-hour training class plus some in-OR coaching. The intervention resulted in performance of a preoperative briefing in 86% of cases 2 weeks after the intervention but this fell to 66% at 6 months post-intervention. There was a modest improvement in formal announcement of intraoperative changes in staffing. There was no significant difference in timing of prophylactic antibiotic administration or case turnover times. A modest improvement in on-time first case starts may have been influenced by a concomitant intervention. A survey showed that 75% of participants had the perception that the briefings provided a better sense of teamwork. However, they noted a marked disparity in those perceptions by discipline, with nurses and anesthesiologists perceiving more benefit from the briefings than surgeons did.
This paper is definitely worth your reading. It details a whole host of lessons learned in implementing a program of this magnitude. They discuss not only the issue of metrics, but also the time and financial resources necessary, resistance to some of the concepts by some individuals, the need to get clinical leaders committed by actions rather than just words, and the issue of sustainability.
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
Halverson AL, Andersson JL, Anderson K, et al. Surgical Team Training. The Northwestern Memorial Hospital Experience. Arch Surg2009; 144(2):107-112
In our Patient Safety Tips of the Week for February 19, 2008 MRI Safety and May 13, 2008 Medication Reconciliation: Topical and Compounded Medications we noted that drug patches may become patient safety issues in patients undergoing MRI. That is primarily because some of the patches contain metal or ferromagnetic elements that may overheat during MRI and cause burns. An article in Medscape had discussed which patches need to be removed prior to MRI and which are safe. That article stressed that communication should take place with the prescribing physician to see whether interruption in that drug therapy would be harmful to the patient. And a pharmacist may help determine whether a removed patch needs to be discarded or can be reused by the patient.
Now the FDA has issued a Public Health Advisory Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings. The FDA notes that not all transdermal patches that contain metal have this warning for patients in the labeling.
FDA is in the process of reviewing the labeling and composition of all medicated patches to ensure that those made with materials containing metal provide a warning about the risk of burns to patients who wear the patches during an MRI scan. But until this review is complete, FDA recommends that healthcare professionals referring patients to have an MRI scan identify those patients who are wearing a patch before the patients have the MRI scan. The healthcare professional should advise these patients about the procedures for removing and disposing of the patch before the MRI scan, and replacing the patch after the MRI scan.
Hulisz DT. Are Topical Patches Safe During MRI or CT Scans? Medscape. May 2, 2008. http://www.medscape.com/viewarticle/572561
FDA. FDA Public Health Advisory. Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings. March 5, 2009
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Though the concept behind deployment of Rapid Response Teams (RRTs) makes good sense, the impact on patient outcomes after deployment of RRTs has been disappointing to date. We first talked about Rapid Response Teams in our August 2007 Whats New in the Patient Safety World column Responding to Patients with Clinical Deterioration. Then, in our November 27, 2007 Patient Safety Tip of the Week More on Rapid Response Teams and our December 2008 Whats New in the Patient Safety World column Rapid Response Teams Dont Live Up to Expectations we discussed the weakness of the evidence supporting a positive effect of rapid response teams on patient outcomes and discussed many of the methodological problems in studies on RRTs.
Now the researchers (Chen et al 2009) involved in one of the largest prospective randomized trials of RRTs have reanalyzed the data from the MERIT study (Medical Emergency Response Intervention and Therapy) and found evidence to support the concept of the early emergency call. The MERIT study was a cluster randomized controlled trial in which hospitals in Australia were randomized into 2 groups: those that had rapid response systems and those that did not. That study failed to demonstrate any significant improvement in outcomes between the RRT hospitals and the control ones. However, when they analyzed the data, they noted that almost half the calls to the cardiac arrest teams in control hospitals were early calls (i.e. before a cardiac arrest) and that at the RRT hospitals many patients who met the criteria for a call to the RRT never had such a call. They speculated that this contamination may have been responsible for the insignificant results in MERIT.
So they reviewed the data, asking the new question were early calls associated with improved outcomes?. Indeed, they found that early calls were associated with reductions in the rate of cardiac arrests and unexpected deaths. For every 10% increase in early calls, there was a 2.2 per 100,000 reduction in cardiac arrests and a 0.94 per 100,000 reduction in unexpected deaths. There was no statistical reduction of overall deaths, unplanned ICU admissions, or an aggregate measure of all the outcomes combined.
So the data do support the concept of developing systems to recognize patients who are clinically deteriorating and respond earlier. What is unclear is what early warning systems work best and how to best respond.
As we have said before, all the negative evidence on use of RRTs does not negate the logic of having a culture of safety that helps recognize early patients that are in need of rescue. Although it does raise many questions about committing many resources to develop RRTs without better evidence-based validation of the RRT concept, the idea remains a sound one but the most appropriate targets, the triggers, the makeup of teams, the mode of response, the logistics, and the best outcome measures all need to be validated before hospitals rush willy-nilly into developing RRTs. The Chen paper would suggest that refining the criteria and system for early recognition may be the best place to start.
In our August 2007 Whats New in the Patient Safety World column Responding to Patients with Clinical Deterioration we discussed 2 UK organizational guidelines on clinical deterioration in acutely hospitalized patients. The UK NHS National Patient Safety Agency had just published its report Safer care for the acutely ill patient: learning from serious incidents and NICE (National Institute for Health and Clinical Excellence) has just released its clinical guideline Acutely ill patients in hospital. Recognition of and response to acute illness in adults in the hospital. The NICE guideline discusses several scoring systems for identification of patients clinically deteriorating, including the MET (single parameter), MEWS (aggregate scoring system) and ASSIST (assessment score for sick patient identification and step-up in treatment aggregate scoring system) systems.
While randomized controlled trials may be needed to determine the best method of responding to critical clinical deterioration of a patient, it remains intuitive that systems which enhance early identification of such clinical deterioration are desirable.Joint Commissions National Patient Safety Goal requiring a plan to Improve recognition and response to changes in a patients condition makes sense even if a traditional rapid response team is not the best way to intervene.
Chen J, Bellomo R, Flabouris A, Hillman K, Finfer S; MERIT Study Investigators for the Simpson Centre; ANZICS Clinical Trials Group. The relationship between early emergency team calls and serious adverse events. Crit Care Med. 2009 Jan;37(1):148-53.
UK NHS National Patient Safety Agency. Safer care for the acutely ill patient: learning from serious incidents. 2007
NICE (National Institute for Health and Clinical Excellence). Acutely ill patients in hospital. Recognition of and response to acute illness in adults in hospital. July 2007
In a prospective multicenter randomized controlled trial, Timsit et al. (Timsit et al 2009) demonstrated that use of chlorhexidine-impregnated sponges in dressings for intravascular catheters reduced rates of catheter-related bloodstream infections (CRIs) by 60%, even in a population with a low baseline rate of CRIs. The reduction was statistically significant, though the number needed to treat (NNT) to prevent one CRI for every catheter was 117. Significant contact dermatitis occurred in 10.4 per 1000 patients or 5.3 per 1000 catheters.
They also demonstrated that changing unsoiled adherent dressings could safely be done every 7 days rather than every 3 days.
The encouraging results were obtained even though most evidence-based practices were already in place to reduce the frequency of CRIs.
Timsit J-F, Schwebel C, Bouadma L, et al for the Dressing Study Group. Chlorhexidine-Impregnated Sponges and Less Frequent Dressing Changes for Prevention of Catheter-Related Infections in Critically Ill Adults: A Randomized Controlled Trial. JAMA. 2009;301(12):1231-1241
AHRQ has put some new Patient Safety Culture Assessment Tools on its website. The following surveys on patient safety culture are available:
These tools are quite good. Not only do they assess the culture of safety, but they also get you thinking about some of the key patient safety areas you may need to spend more time on.
Speaking of patient safety culture surveys, Press Ganey has released their 2009 report on Safety Culture and it contains some very interesting observations and recommendations. Of the 13 dimensions of safety culture they address, the two areas most in need of improvement are non-punitive response to error and handoffs/transitions.
The perception of safety culture varies greatly by staff position, degree of patient contact, number of hours worked, amount of years in an organization, work area, organization size, and even governance. Management and staff with little patient contact tend to have much higher perceptions of patient safety culture than do front-line workers. Similarly, staff in very complex clinical areas have lower perceptions of safety culture. And new staff have better perceptions than staff who have been employed for longer periods.
The report provides some examples of how specific organizations have been able to use the results of their surveys to improve patient safety culture. Concepts like safety chats and safety coaches are highlighted. And they stress the importance of continued training in patient safety for all staff, not just at the time of initial orientation. This report is worth reading. Its clear that Press Ganey uses its survey tools to help organizations actually improve patient safety, not just to make the organizations feel good about it.
And while you are at it, take a look at ECRI Institutes new programs for physician practice patient safety and risk management. They cover a broad range of topics that will improve the safety of your patients and improve your overall efficiency and probably your bottom line.
AHRQ. Patient Safety Culture Surveys. 2009
Press Ganey. P u l s e R e port 2009. Safety Culture. Staff Perspectives on American Health Care. 2009
ECRI Institute. Patient Safety, Risk Assessment and Management
Our January 27, 2009 Pattient Safety Tip of the Week Oxygen Therapy: Everything You Wanted to Know and More! summarized the new British Thoracic Society (BTS) guideline on oxygen therapy.
A 2-part series on implementation of these guidelines from a nursing perspective has appeared in Nursing Times in March 2009 (Smith et al 2009 Part 1, Smith et al 2009 Part 2). While this largely reiterates many of the key points in the BTS guideline, it does have some very practical tips. For example, it describes barriers to appropriate management, such as need for removal of nail polish to prevent inaccurate pulse oximetry readings or use of an ear probe in patients severely vasoconstricted peripherally. It also points out that oxygen therapy is intended to treat hypoxemia, not breathlessness. But it does discuss approaches to the breathless patient. In a discussion about mucus plugging, it notes that there is little evidence that humidification with high-flow oxygen is effective and the oxygen guideline recommends that a bubble bottle should not be used but that single doses of nebulised normal saline have been shown to help in sputum clearance and reduce breathlessness in patients with COPD
Smith, S.M.S. et al. Emergency oxygen delivery in adults 1: updating nursing practice. Nursing Times 2009; 105: 10, 1618 March 13, 2009
Smith, S.M.S. et al. Emergency oxygen delivery 2: patients with asthma and COPD. Nursing Times 2009; 105: 11 March 24, 2009
While we try to avoid climbing on our soapbox to express our views on where we need to go in reforming our healthcare system, recently there have been several articles that deal with both quality and patient safety and highlight problems with our current healthcare system that need to be addressed in any reform effort. The articles address key issues in healthcare delivery (providing care in the most cost-effective venue, avoiding conflicts of interest, restoring the medical research enterprise to a more objective format, expanding the role of the FDA to better monitor drug safety after drug approval, and use of evidence-based practices that improve patient safety). Collectively, the elements in just these articles have the potential to save billions of dollars to our healthcare system. While universal healthcare coverage is something we must achieve, the potential savings from implementation of lessons in these articles is crucial for reform of our healthcare system to be successful.
Weve already been addressing in many columns reforms to the Medicare payment system that have addressed never events and readmissions. We think the next target is likely to be avoidable admissions. The Healthcare Cost and Utilization Project (HCUP) has just released its report on the frequency and costs of potentially preventable hospitalizations for 2006. Basically, potentially avoidable hospitalizations are a group of ambulatory care-sensitive conditions that, at least in theory, could be managed appropriately on the outpatient side so that hospitalization could be avoided. Of course, not all such admissions are preventable. For example, the risk of hospitalization for community-acquired pneumonia can be reduced by both influenza and pneumococcal vaccination and good management of underlying chronic conditions. But even previously healthy patients can get pneumonia severe enough to require hospitalization.
The HCUP study identified over 4 million hospitalizations in the potentially preventable category in 2006, responsible for over $30 billion of healthcare expenses. So even if only some of these admissions were preventable there is still considerable potential savings. The HCUP study showed that the rates of preventable hospitalizations were considerably higher for Medicare patients than for those with private insurance. Also, patients from poorer communities were much more likely to have preventable hospitalizations than those from wealthier communities.
Hospitals have little control over many of these admissions, unless the patients receive their primary ambulatory care in that hospitals system. So hospitals should not be penalized for these potentially avoidable admissions. That is in contradistinction to the argument about hospital readmissions, where hospital activities may play a big role. So where would CMS and other payors look to save the dollars from? The most obvious way to get incentives aligned for all parties will be to encourage true integrated healthcare delivery systems in the future that would receive global budgets or full capitation. That way the primary care delivery system will be incentivized to avoid these potentially preventable admissions. It is issues like these that mandate we restructure our healthcare payment system to help rationalize our healthcare delivery system across the entire continuum.
H. Joanna Jiang, Ph.D., C. Allison Russo, M.P.H., and Marguerite L. Barrett, M.S. Nationwide Frequency and Costs of Potentially Preventable Hospitalizations, 2006. The Healthcare Cost and Utilization Project (HCUP). April 2009
The Institute of Medicine (IOM) has finally released its reportConflict of Interest in Medical Research, Education, and Practice. One of the biggest reasons for rising healthcare costs is related to pharmaceutical and medical device costs. Some of the techniques used to increase demands for these products have been well publicized. Ghost writing (where the company basically writes the paper and gets someone else to agree to be the primary author), no matter how unethical, is a well-known phenomenon. Paying well-respected physicians or opinion leaders to speak at meetings and luncheons or dinners about the benefits of a drug or device (often for an off-label indication) is a tactic that often results in increased product sales or use. Negative studies (clinical trials that failed to show a beneficial effect of the drug or device compared to the control group) almost never get published. Until recently, the data from such negative studies was never available to any parties other than the industry sponsor (now clinical trial data is supposed to be posted publicly, though there is not yet full compliance with that). And in many cases, the researcher or the university has a financial interest in a study producing a positive outcome (eg. they may hold a patent on the drug, test, or device). Device manufacturers have paid large consulting fees to physicians who are in a position to get hospitals to purchase their devices. National standards and clinical guidelines are often written by panels on which there are individuals receiving considerable funding from industry. Industry also provides physicians a variety of freebies either directly or indirectly by sponsoring CME courses. And those of us who claim those things dont influence my practice are in a state of denial. And the conflicts of interest do not just involve the physician community. Some organizations established to advocate for patients with a particular disease or conditon are often heavily subsidized by the companies who have the most to gain by promotion of their products. The conflicts go on and on. The result is that many of our patients receive treatments that ultimately are found to be either no more beneficial than a current treatment or in some cases actually harmful to them.
All these are examples noted in the IOM report. The report calls for substantial reform in how these conflicts of interest are both declared and managed. Our own feeling is that the only real way to avoid such conflicts of interest is to return research to financially disinterested parties. Whereas in the past most medical research was performed by academic medical centers and sponsored by NIH or other non-industry sponsors, now most research is sponsored and funded by the industry itself. So the governments failure over the years to provide adequate research funding and oversight has really allowed medical research to be hijacked by the very parties likely to have conflicts of interest. Failure to adequately fund the national research endeavor thus has actually been one of the root causes of our rising healthcare costs.
Institute of Medicine. Conflict of Interest in Medical Research, Education, and
Practice. Report Brief April 2009
Sometimes certain practices get incorporated into clinical practice without a solid evidence base. Only years later do we recognize that such practices may actually be harming patients. Erythropoiesis-stimulating agents are a prime example. The evidence base for using these agents in some conditions has been surprisingly weak. Yet they have become a mainstay in treatment of chronic kidney disease and chemotherapy-associated anemia. In the previous section we noted how some conflicts of interest may lead to excessive or unnecessary use of certain products. Well, economic incentives to providers have played a huge role in not only using erythropoiesis-stimulating agents in many conditions but also in using them in higher and higher doses. Direct-to-consumer advertising undoubtedly has also played a role in promoting their use.
Only in the last couple years did the possibility of an adverse effect of these agents on mortality become apparent. The practice of aiming for higher target hemoglobin levels came under fire when it was demonstrated that mortality was higher in groups randomized to higher hemoglobin targets (Phrommintikul et al 2007). Now a new meta-analysis of randomized controlled trials of erythropoiesis-stimulating agents in cancer patients (Bohlius et al 2009) has demonstrated higher mortality in those treated with erythropoiesis-stimulating agents and transfusions compared to those treated with transfusions alone. The higher mortality rates were seen in cancer patients whether or not they were being treated with chemotherapy and was seen across a variety of cancers and cancer treatments. The mortality rates were higher during the active treatment period and overall survival was also affected.
Admittedly, there may be benefits of such agents on quality of life. But we need to make sure we appropriately weigh those potential benefits against the risks.
And, again, the lesson here is that continued surveillance is needed long after initial FDA approval of drugs and devices. The failure of our system to effectively carry out that surveillance has often led to adverse outcomes for our patients and contributed to the rapidly rising costs of healthcare in our current system.
Phrommintikul A, SJ, M, Krum H. Mortality and target haemoglobin concentrations in anaemic patients with chronic kidney disease treated with erythropoietin: a meta-analysis. The Lancet 2007; 369: 381 - 388
Bohlius J, Schmidlin K, Brillant C, et al. Recombinant human erythropoiesis-stimulating agents and mortality in patients with cancer: a meta-analysis of randomised trials. The Lancet 2009; 373: 1532 - 1542
The National Quality Forum (NQF) has issued its 2009 Update to its Safe Practices for Better Healthcare. The original set of safe practices was developed in 2003 and updated in 2006. The current update adds 7 new practices to the set and consolidates several others. Each of the previous practices is also updated where new evidence-based practices have become available.
Each safe practice is discussed in a chapter in the report and there is a discussion of the nature and scope of the problem, the evidence base, the potential economic impact, the settings to which the practice is applicable (though most of the practices apply to all healthcare settings), the appropriate monitoring and measurement strategies, the recommended practices, and the areas for further research.
The report comes in a paperback version for $89.99. It also is available in a downloadable pdf file for $29.99. We prefer the latter not only is it less expensive but you can easily use the search capabilities to find specific details.
Use of practices that promote patient safety not only benefits our healthcare system in terms of patient outcomes and satisfaction but has a huge potential economic savings to the healthcare system as well.
NQF. Safe Practices for Better Healthcare - 2009 Update A Consensus Report. NQF. March 2009
John Nances new book (see our June 2, 2009 Patient Safety Tip of the Week Why Hospitals Should FlyJohn Nance Nails It!) drives home the compelling message that our failure to significantly impact patient safety outcomes since the 1999 IOM report To Err is Human is really due to our failure to develop a culture of safety. We have talked in the past on numerous occasions about tools used to assess the culture of safety in healthcare organizations. Our endorsement of these tools has been a cautious one because we have seen that the culture in one area of the organization may be significantly different from that in other areas. We also feel that you can get a much better understanding of the culture at the unit level when you routinely do patient safety walk rounds. Most published reports on survey results confirm marked variation in perception of patient safety culture by unit type and by type of respondent.
But that does not mean that these tools do not provide useful information. Just doing the survey raises awareness of patient safety issues and does allow identification of problem areas where extra attention needs to be focused.
Hospitals have been using the AHRQ Survey on Patient Safety Culture since 2004. That survey focuses on 12 areas of patient safety culture and contains 42 items in all. Since 2007 AHRQ has been releasing a comparative database report on the survey results, allowing hospitals to compare where they stand compared to other hospitals. AHRQ has just released its Hospital Survey on Patient Safety Culture: 2009 Comparative Database Report. The results are also made available sorted by hospital type, size (bed number), and the position/specialty of the reporters.
Not surprisingly, reporters not having direct patient care responsibilities (eg. hospital administrators) typically have a more positive perception of patient safety culture at their institutions than do those reporters with direct patient care responsibilities. We saw the same trend in Press Ganey's 2009 report on Safety Culture which we commented on in our April 2009 Whats New in the Patient Safety World column April 2009 New Patient Safety Culture Assessments. This certainly highlights the importance of understanding whose perception of patient safety you are seeing. If you are a Board member of a healthcare organization, you can expect that your C-suite evaluation of the patient safety culture will be rosier than what it is in reality. Therefore, you should be looking for the perception of those on the front lines, those with direct patient care responsibilities.
The AHRQ trended surveys show overall positive responses for the areas of teamwork within units and overall patient safety grade. But areas for improvement include nonpunative response to error and handoffs and transitions. The Press Ganey report also highlighted these as weaknesses. The AHRQ surveys also found number of events reported as an area needing improvement. That is no surprise to us. For years we saw striking disparities in incident reporting by hospitals in New York. And, of course, it is those hospitals reporting greater numbers of incidents that have begun to develop that culture of safety and are learning from their experiences. That is a big criticism of statewide comparative incident reporting systems in that their publication of numbers of incidents may unintentionally steer patients to hospitals that actually have more patient safety problems.
Smaller hospitals generally had more positive responses to all the patient safety culture survey areas. The difference when compared to large hospitals was most noticeable for handoffs and transitions. That is not surprising, since at smaller hospitals you tend to find more staff very familiar with each other. We still dont know the optimum size for hospitals at which quality and patient safety outcomes are best. But we are always reminded of the magic number from Malcolm Gladwells book The Tipping Point. He cited research from multiple sources and multiple different organizations showing that when organizations or units exceed 150 members, organizational dysfunction increases. That is most likely due to the fact that in the smaller organization most people know each other by first name, are more likely to work together as a team, and better utilize both peer pressure and peer learning to reach their common goals.
AHRQ. Hospital Survey on Patient Safety Culture: 2009 Comparative Database Report
Press Ganey. P u l s e R e port 2009. Safety Culture. Staff Perspectives on American Health Care. 2009
Most of you know that the trend in hospital design has been toward providing more single patient rooms. That has largely been driven by the epidemic of hospital-acquired infections such as MRSA, VRE, and C. diff. but there are a variety of other evidence-based concepts suggesting single patient rooms should be the wave of the future.
In the past year we have seen two monographs on evidence-based hospital design, The Joint Commissions Guiding Principles for the Development of the Hospital of the Future and a paper in this year IHIs Innovation Series entitled Using Evidence-Based Environmental Design to Enhance Safety and Quality. And since we are big on John Nance this month, his description of the patient rooms and relationship to nursing presence in his new book (see our June 2, 2009 Patient Safety Tip of the Week Why Hospitals Should FlyJohn Nance Nails It!) uses heavily the concepts in these works.
But is everyone on board? Of interest, two publications in the lay press last month just days apart but an ocean apart seemed to espouse different views. An article in the New York Times focused on the benefits of single-patient rooms. Benefits include increased privacy, improved sleep, and reduced infections and stress. But an article in The Herald highlighted a new Scottish study that more than half of hospital patients in Scotland would prefer to stay in a ward than a private room. They note that some of the prior studies showing that patients would prefer single private rooms had been done on younger, primarily surgical patients. They feel that their new study, done on older mixed med/surg patients, may be more reflective of the general hospital population. They point out that the Scottish Single Room Provision Steering Group Report, which mandated all new hospitals in Scotland should be built with only single beds, pointed out that the evidence base is, in fact, not terribly strong.
Perhaps the loneliness factor cited in The Herald article can be overcome by design features that can still occur with single rooms. Many of the features described in John Nances book where patients are kept in proximity not only to other patients but also to their primary nurse are probably important design features.
At any rate, all the above articles are good reading since they get you to think about incorporating patient safety and communication principles into the design of new things.
Guiding Principles for the Development of the Hospital of the Future.
The Joint Commission. 2008
Sadler BL, Joseph A, Keller A, Rostenberg B. Using Evidence-Based Environmental Design to Enhance Safety and Quality. IHI Innovation Series white paper. Cambridge, Massachusetts: Institute for Healthcare Improvement; 2009
Health Outcomes Driving New Hospital Design
By CAROL ANN CAMPBELL
NY Times Published: May 18, 2009
Carolyn Churchill. Hospital patients want wards rather than private rooms. The Herald. Web Edition. May 21 2009
The Scottish Government. Single Room Provision Steering Group Report. December 2008.
Ulrich R, Quan X, Zimring C, Joseph A, Choudhary R. The Role of the Physical Environment in the Hospital of the 21st Century: A Once-in-a-Lifetime Opportunity.
Chaudhury H, Mahmood A, Valente M. Advantages and disadvantages of single- versus multiple-occupancy rooms in acute care environments: A review and analysis of the literature. Environment and Behavior 2005; 37(6): 760-786
As most of you know, The Joint Commission plans no new National Patient Safety Goals for 2010. Instead, it is reviewing and revising the current NPSGs. On May 12 they posted the suggested revisions to the NPSGs and Universal Protocol. These are available for downloading at this site. Most of the revisions are wordsmithing and consolidation of several elements of performance for each NPSG into one element of performance. Others involve moving a NPSG or element of performance to standards. You may submit for comments about the proposed revisions to The Joint Commission via that site for most of June.
Joint Commission. Proposed Revisions to National Patient Safety Goals and Universal Protocol forHospitals
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