What’s New in the Patient Safety World

April 2011



·        Ob/Gyn Patient Safety Programs

·        Harm from “NPO” Orders

·        FDA Reissues Wound Device Alert

·        HIT Turning the Corner?

·        Nursing Staffing and Mortality






Ob/Gyn Patient Safety Programs



We have not done many columns on patient safety in obstetrics and gynecology. Our September 7, 2010 Patient Safety Tip of the Week “Patient Safety in Ob/Gyn Settings” highlighted several programs and recently we wrote about too many early labor inductions (see our February 8, 2011 Patient Safety Tip of the Week “Inducing Too Early”).


In the last month there have been three publications about comprehensive ob/gyn patient safety programs. Interventions included team training, simulation, use of evidence-based protocols, and electronic fetal monitoring certification programs, among other programs. One (Wagner 2011) used the modified Adverse Outcome Index (MAOI) to monitor adverse events and documented significant and sustained reductions in the MAOI. Another (Grunebaum 2011) showed a dramatic reduction in sentinel events from 5 per year to none and (malpractice) compensation payments dropped from an average of $27M per year down to $ .5M per year. The third (Shannon 2011) also demonstrated both improvements in the Adverse Outcome Index and a reduction in malpractice claims. One insurer reduced malpractice premiums for obstetricians who participated in the training program. The latter provides good stories about how the teamwork training developed at one institution spilled over to multiple institutions and other departments.


These programs shared many features in common with the MOREOB Program (see our September 7, 2010 Patient Safety Tip of the Week “Patient Safety in Ob/Gyn Settings”) that focused on communication and teamwork building, skill building, culture of safety, emergency skill drills, education, and use of patient safety tools like RCA, FMEA, near miss reviews, audits, etc. That program has reduced NICU admissions and resulted in fewer neonates with respiratory distress, sepsis, CNS hemorrhage, and a variety of other neonatal and maternal outcomes.


In addition to the improvements in safety of obstetrical care, there were numerous other valuable benefits of the teamwork training. The Shannon article discusses how the teamwork training led to staff better dealing with conflict and disruptive behavior.






Grunebaum A, Chervenak F, Skupski D. Effect of a comprehensive obstetric patient safety program on compensation payments and sentinel events. Review Article.

Am J Obstet & Gynecol 2011; 204(2): 97-105


Wagner B, Meirowitz N, Shah J, et al. Comprehensive Perinatal Safety Initiative to Reduce Adverse Obstetric Events. Journal of Healthcare Quality 2011; published online March 1, 2011




Shannon D. Obstetrical Team Training: How the Response to a Tragic Event Revolutionized Care Across the Country. Physician Executive Journal 2011; March•april/2011 pp. 4-11




MOREOB Program





Print “April 2011 Ob/Gyn Patient Safety Programs





Harm from “NPO” Orders



We usually issue “NPO” (nothing by mouth) orders to protect patients. For example, in appropriate care of the stroke patient we keep them “NPO” until we have done a swallowing assessment and are reasonably sure the patient will not aspirate when we begin food or liquids by mouth. Similarly, patients are often kept “NPO” prior to a surgical procedure to reduce the risk of aspiration. But the UK National Patient Safety Agency recently issued a “signal” about patients being harmed while “NPO”.


They found over 100 occurrences in their incident databases of patients being inadvertently kept “NPO” for prolonged periods and being potentially vulnerable to dehydration, malnutrition or delayed or missed medications. During these delays there is often inattention to several of these patient needs. As in most significant adverse events with harm, communication issues are prominent. For example, when a scheduled surgery is cancelled there may be inadequate communication between services or or sites such that an order to resume feeding never takes place.


The NPSA suggests that each organization consider that appropriate documentation for an “NPO” order include the date, time and staff who will be responsible for review of that order and that such orders be accompanied by a plan for alternative methods of hydration, nutrition and medication administration. They also recommend that there be clear communication about the patient status among all members of the healthcare team, including dietary and housekeeping staffs.


We recommend you do a simple audit on several units to see (a) how many patients are on “NPO” status and (b) why are they “NPO” and (c) are their nutritional, hydration, and medication needs being met. You may identify gaps and identify communication barriers. You may also identify other related issues. For example, you may find a patient has a central line in place for hydration or parenteral alimentation that is no longer necessary (because they are capable of feeding) yet puts them at risk for nosocomial bacteremia (CLABSI).


So, while the “NPO” order sounds like a protective or at least harmless order in most circumstances, you can see its potential to lead to harm.






National Patient Safety Agency (UK). Risk of harm to patients who are nil by mouth. February 14, 2011






Print “April 2011 Harm from “NPO” Orders






FDA Reissues Wound Device Alert



Negative pressure wound therapy (aka “wound vac” or NPWT) has been being used much more frequently in recent years for managing a variety of wounds. There has always been considerable debate about the strength of evidence for its efficacy and the overall cost-effectiveness. All of us, however, have probably seen individual cases of difficult-to-heal wounds that dramatically improved after initiation of negative pressure therapy. But in recent years a number of adverse events related to these devices has begun to emerge.


In 2009 the FDA issued an alert about potential dangers associated with use of negative pressure wound therapy devices (see our December 2009 What’s New in the Patient Safety World column “FDA Safety Alert on Negative Pressure Wound Therapy Systems”). That preliminary safety alert about negative pressure wound therapy and an associated consumer alert were based on reports of 6 deaths and 77 injuries reported over the period from 2007 to 2009 and were followed by an update in 2010.


Now the FDA has issued yet another update, based upon reports of 6 additional deaths and 97 additional injuries since the 2009 alert, bringing the totals to 12 deaths and 174 injuries related to the NPWT devices. The FDA has emphasized the fact that in many of the cases the adverse events occurred in patients being treated at home or in long-term care facilities.


Serious bleeding continues to be the most serious complication. This was seen in patients with vascular grafts, wound infections, patients on anticoagulants, or during removal of dressings attached to the tissues. However, many of the recent reports also deal with infection related to retention of dressing pieces in the wounds.


The FDA update provides advice for both healthcare professionals and for patients and their families. They list several types of wounds for which NPWT is contraindicated including those with necrotic tissue with eschar present, untreated osteomyelitis, non-enteric and unexplored fistulas, malignancy in the wound, and those with exposed vasculature, nerves, organs or anastomotic sites. They also list risk factors that may predispose to these complications and make recommendations about ensuring that the patient and/or caregiver has been appropriately instructed on use of the system and how to recognize and address complications.


Talk about good timing – there are two new review articles on NPWT. The Pennsylvania Patient Safety Authority has a review article “Improving the Safety of Negative-Pressure Wound Therpy” in it March issue of the Pennsylvania Patient Safety Advisory. This is an excellent review of the evidence base for NPWT, which they admit is weak, the theories about how NPWT works, and economic analyses that suggest it may be a cost-effective alternative to other wound therapies. It highlights the adverse effects noted in the original FDA alert(s) and discusses examples of 419 events reported to the PPSA in 2008-2009. It then provides advice not only about initiation of NPWT but also about when to stop it, and guidelines about assessment of the patients, wound preparation, application of the device, ongoing monitoring and assessment, and education of the patient and family caregiver.


The second new article (Moues 2011) is a critical review of the evidence base for NPWT. It reviews the evidence for the various claimed mechanisms of action for NPWT and reviews the evidence for the clinical utility of NPWT. It points out that many of the uses have been based on consensus statements rather than based in high-level clinical studies and highlights the need for future research in several areas. It also provides an excellent reference list. It does not, however, focus on adverse events associated with NPWT.






FDA Preliminary Public Health Notification*: Serious Complications Associated with Negative Pressure Wound Therapy Systems

Date: November 13, 2009




FDA. Consumer Alert. Negative Pressure Wound Devices Draw FDA Notice, Advice. 2009




Mirsaidi N. Negative pressure wound therapy: Use with care. Nursing 2010, September issue, p.64-66




FDA. FDA Safety Communication: UPDATE on Serious Complications Associated with Negative Pressure Wound Therapy Systems. Date Issued:  February 24, 2011




Pennsylvania Patient Safety Authority. Improving the Safety of Negative-Pressure Wound Therapy. Pa Patient Saf Advis 2011; 8(1): 18-25.




Mouës CM, Heule F, Hovius SER. A review of topical negative pressure therapy in wound healing: sufficient evidence? American Journal of Surgery 2011; 201(4): 544-556, April 2011






Print “April 2011 FDA Reissues Wound Device Alert





HIT Turning the Corner?



A number of studies have failed to show demonstrable improvement in patient outcomes with health information technology (HIT) interventions and much has been written about the unintended consequences of HIT.


But HIT may be turning the corner. A recent paper (Harrington 2011) outlining many of the negative papers on HIT noted that the number of such papers seemed to have peaked in 2005 and diminished in recent years. Another (Buntin 2011) showed that 92% of papers on HIT published since 2007 were positive overall.


Yet another (Zlabek 2011) showed some significant improvements in quality, efficiency and costs. After implementation of an inpatient EMR (electronic medical record), medication errors dropped significantly, the number of lab and radiology tests dropped substantially, and transcription costs dropped dramatically. Even more impressively, the gains were made within a year of implementation.


And another (Jayaram 2011) showed that CPOE with clinical decision support and a computer-based error reporting system led to a dramatic reduction in medication errors on behavioral health units.


It’s likely that many of the “kinks” in the system are being worked out and that better design and redesign (both of software and workflows) and more appropriately tailored decision support tools have finally avoided many of the unintended consequences that had reduced the positive impact of EMR’s.






Harrington L, Kennerly D, Johnson C. Safety Issues Related to the Electronic Medical Record (EMR): Synthesis of the Literature from the Last Decade, 2000-2009. Journal of Healthcare Management 2011; 56(1): 31-43


Buntin MB, Burke MF, Hoaglin MC, Blumenthal D. The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results. Health Affairs 2011; 30: 3464-471; doi:10.1377/hlthaff.2011.0178




Zlabek JA, Wickus JW, Mathiason MA. Early cost and safety benefits of an inpatient electronic health record. JAMIA 2011; 18: 169-172  Published Online First: 2 February 2011




Jayaram G, Doyle D, Steinwachs D, Samuels J. Identifying and Reducing Medication Errors in Psychiatry: Creating a Culture of Safety Through the Use of an Adverse Event Reporting Mechanism. Journal of Psychiatric Practice 2011; 17(2): 81-88, March 2011





Print “April 2011 HIT Turning the Corner?





Nursing Staffing and Mortality



Many articles have been written about the relationship between low nursing staffing levels and a variety of adverse events and patient mortality. Many have been criticized because of the methodologies or data sources used. A new study (Needleman 2011) uses an improved methodology and corrects for many of the concerns of previous studies and concludes that both low nursing staffing levels and that higher than normal nursing workloads also correlate with increased patient mortality rates.


The authors looked at data from a large academic medical center that, in general, had relatively good nurse staffing rates. They were able to quantify nurse staffing on a shift-to-shift and unit-by-unit basis and match this to both patient census and workload (as measured by patient turnover rates). They demonstrated a significant correlation between patient mortality rates and patient exposure to 3 or more shifts with below-target nursing staffing or 3 or more shifts with high patient turnover.


This study, in conjunction with the numerous prior studies, should leave little doubt about the importance of matching nursing staffing levels to the needs of patients (both census and acuity).






Needleman J,  Buerhaus P,  Pankratz VS, et al. Nurse Staffing and Inpatient Hospital Mortality. N Engl J Med 2011; 364:1037-104





Print “April 2011 Nursing Staffing and Mortality





Print “April 2011 What's New in the Patient Safety World (full column)

Print “April 2011 Ob/Gyn Patient Safety Programs

Print “April 2011 Harm from “NPO” Orders

Print “April 2011 FDA Reissues Wound Device Alert

Print “April 2011 HIT Turning the Corner?

Print “April 2011 Nursing Staffing and Mortality










Patient Safety Tip of the Week Archive


What’s New in the Patient Safety World Archive