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What’s New in the Patient Safety World

August 2021



·       Antibiotic Stewardship in Pediatrics

·       Updated Guidelines on C. diff

·       New Blood Management Guidelines for Cardiac Surgery

·       The New NY State Law on Nursing Staffing



Antibiotic Stewardship in Pediatrics



Inappropriate use of antibiotics is a problem for all patient populations, but it has long been a particular problem in pediatrics. One condition for which antibiotics are overprescribed is acute otitis media (AOM), the most-common indication for antibiotics in children. Delayed antibiotic prescribing for AOM can significantly reduce unnecessary antibiotic use and is recommended by the American Academy of Pediatrics for select children. A delayed antibiotic prescription is a prescription given to the caregiver to fill in the event that the child’s symptoms worsen or fail to improve after 48 to 72 hours.


A recent study sought to improve delayed prescribing for AOM across 8 outpatient pediatric practices in Colorado. Frost et al. (Frost 2021), through a collaborative initiative with American Academy of Pediatrics and the Centers for Disease Control and Prevention, implemented a low-cost 6-month antimicrobial stewardship intervention that included education, audit and feedback, online resources, and content expertise.


Practices varied by size (range: 6–37 providers), payer type, and geographic setting. Overall, 69 clinicians at 8 practice sites implemented the project.


The rate of delayed antibiotic prescribing increased from 2% at baseline to 21% at intervention end (RRR 8.96). Five practices submitted postintervention data. The rate of delayed prescribing at 3 months and 6 months postintervention remained significantly higher than baseline (RRR 3 months postintervention 8.46; 6 months postintervention 6.69.


So what, exactly, did the intervention entail? There were 3 educational sessions (a full day in-person learning session and two 90-minute virtual sessions covering the CDC Core Elements of Outpatient Antibiotic Stewardship and the Institute for Health Improvement Model of Improvement QI frameworks). There were also 4 monthly 60-minute webinars to review data and discuss PDSA cycles. There was also subject matter expert support and access to an online community collaborative Web site. CME credits and maintenance of certification (MOC) credits were also provided. Education included content on effective communication to reduce antibiotic use by using the Dialogue Around Respiratory Treatment method. All practices were provided templates for delayed prescribing-focused patient education material (handouts and posters).


Each practice site had a QI team including, at a minimum, a physician practice champion, an office administrator, and a nurse or medical assistant; required attendance at educational sessions; development and execution of monthly PDSA cycles; submission of monthly provider-level data; and completion of surveys. In total, 27 PDSA (plan-do-study-act) cycles were completed by the 8-practice teams.


We’ve often said that education and training seldom result in sustained behavioral improvement. But in this collaborative the intervention was more than just an educational one. Adoption of good QI techniques, including PDSA cycles with audit and feedback likely played a pivotal role. And, undoubtedly, the collaborative had a beneficial impact on team building and safety culture at the practice sites.


Will the results be sustainable beyond a year? Only time will tell. But we’d expect that, once parents and other caregivers have been exposed to the concept of delayed prescribing, they will look to delayed prescribing the next time their child has a bout of AOM, thus further sustaining the improvement.


Good work!


Some of our prior columns on antibiotic stewardship:






Frost, HM, Monti JD, Andersen LM, et al. Improving Delayed Antibiotic Prescribing for Acute Otitis Media. Pediatrics 2021; 147(6): e2020026062





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Updated Guidelines on C. diff



The American College of Gastroenterology has updated guidelines on prevention, diagnosis, and treatment of C. diff (Kelly 2021), its first update since 2013. Though we’ll always continue to refer to it as C. diff, the guidelines acknowledge the name change to Clostridioides difficile (it was formerly named Clostridium difficile). Overall, they make 23 GRADED recommendations for the management regarding C. diff.


While there had been a substantial increase in C. diff incidence over the first decade of this century, the estimated national burden of C. diff infection and associated hospitalizations decreased from 2011 through 2017, owing to a decline in health care–associated infections (Guh 2020). C. diff burden in long-term care facilities also saw a decrease. These suggest that efforts at reducing CDI in hospitals and other healthcare facilities have been successful.


Perhaps the most important change in the updated guidelines is inclusion of fecal microbial transplant (FMT) as a treatment for C. diff infection (CDI). But the guidelines also include new recommendations on diagnostic testing, and use of bezlotoxumab in prevention of CDI recurrence.


The guidelines cover management of all levels of severity of C. diff, from asymptomatic colonization to severe infection. Criteria for definitions of “severe” and “fulminant” CDI are included in the guideline.


Differentiating colonization from infection has been improved with adoption of new testing capabilities. The guideline notes that only individuals with symptoms suggestive of active CDI should be tested (3 or more unformed stools in 24 hours). A two-step diagnostic process is now recommended, with stool being first tested using a test with high sensitivity, such as nucleic acid amplification testing or glutamate dehydrogenase, and then followed by highly specific enzyme immunoassay.


For nonsevere CDI, either oral vancomycin or oral fidaxomicin are recommended, though the guideline also notes oral metronidazole may be used in low-risk patients.


For severe CDI, 10 days of oral vancomycin or oral fidaxomicin is recommended.


For fulminant CDI, oral vancomycin plus fluid resuscitation is recommended. Adding parenteral metronidazole is noted as an option, though the guideline notes the level of evidence for this is of low quality.


See the guideline itself for the recommended doses of the various antimicrobials in each situation discussed.


The major update is use of fecal microbial transplant (FMT) in cases of severe or fulminant CDI that are resistant to antibiotics. FMT is also now used to prevent recurrence in patient at high risk.


Prevention/prophylaxis is also discussed. Oral vancomycin prophylaxis can be used when patients with a history of CDI undergo subsequent use of systemic antibiotics. As noted above, fecal microbial transplant (FMT) can be used to prevent recurrence in patient at high risk (and may need to be repeated one or more times). Another new recommendation is for use of the monoclonal antibody bezlotoxumab for prevention of CDI recurrence in patients at high risk of recurrence.


Note that the guideline recommends against use of probiotics either in prevention of recurrent CDI or as prophylaxis in patients on antibiotic therapy, citing lack of strong evidence.


The guideline also includes recommendations for special circumstances, such as pregnancy and lactation, inflammatory bowel disease, immunocompromised states, and patients requiring surgical intervention.


We should note that there have been several other good reviews of C. diff management in recent years (Wilcox 2019, Rao 2020, Cho 2020).


The new ACG guidelines did not to make GRADE recommendations regarding infection control and prevention. Instead, they pointed to other published guidelines having comprehensive recommendations for preventing CDI. They note that clinical practice guidelines from the IDSA/SHEA and European Society of Clinical Microbiology and Infectious Diseases recommend isolating patients with suspected or confirmed CDI, use of full barrier precautions (i.e., gowns and gloves) while caring for these patients, and hand hygiene before and after contact with patients with CDI, preferably using soap and water. They note that none of these guidelines recommend contact precautions in asymptomatic carriers. They do stress use of antibiotic stewardship programs that restrict high risk antimicrobials and minimize unnecessary antimicrobials to control rates of CDI.


Barker et al. (Barker 2020) evaluated the cost-effectiveness of infection control strategies to reduce hospital-onset C. diff infection. Interventions considered included daily sporicidal cleaning, terminal sporicidal cleaning, health care worker hand hygiene, patient hand hygiene, visitor hand hygiene, health care worker contact precautions, visitor contact precautions, C difficile screening at admission, and reduced intrahospital patient transfers. Their evaluation suggests that institutions should seek to streamline their infection control initiatives and prioritize a smaller number of highly cost-effective interventions. Daily sporicidal cleaning was among several cost-saving strategies that could be prioritized over minimally effective, costly strategies, such as visitor contact precautions.


Lastly, one problem not discussed in the updated AGS guideline is that of overtesting for C. diff. Dunn et al. (Dunn 2020) did a systematic review of studies evaluating the association between clinical decision support (CDS) alerts for CDI diagnosis and CDI testing volume and/or CDI rate. They conclude that the use of electronic alerts for diagnostic stewardship for C. difficile was associated with reductions in CDI testing, the proportion of inappropriate CDI testing, and rates of CDI in most studies. But they also noted that broader concerns related to alerts remain understudied, including unintended adverse consequences and alert fatigue.


It’s pretty clear that considerable progress has been made on reducing the burden of C. diff on our patients and our healthcare system.





Since we initially wrote this column, IDSA (Infectious Diseases Society of America) and SHEA (Society for Healthcare Epidemiology of America) published their 2021 Focused Update Guidelines on Management of Clostridioides difficile Infection in Adults (Johnson 2021).


The guidelines are fairly similar, though there are a few somewhat controversial differences (Willingham 2021). Probably the biggest difference iin the choice of antimicrobial for an initial episode of C. diff infection. The IDSA/SHEA guideline update makes a “conditional” recommendation for use of fidaxomicin as first preferred choice over vancomycin. It states this recommendation is based upon efficacy and safety, with a moderate certainty of evidence, but notes “its implementation depends on available resources" (the cost of  fidaxomicin is considerably higher than that for vancomycin). It does list vancomycin as an acceptable alternative.


The IDSA/SHEA guideline update also recommends fidaxomicin over a standard dose of vancomycin for recurrent CDI (again, a conditional recommendation, based on low certainty evidence). For patients with multiple recurrences, vancomycin in a tapered and pulsed regimen, vancomycin followed by rifaximin, and fecal microbiota transplantation are options in addition to fidaxomicin.


Another conditional recommendation is for patients with a recurrent CDI episode within the last six months.  The IDSA/SHEA guideline update suggests using bezlotoxumab as a co-intervention along with standard of care antibiotics rather than standard of care antibiotics alone. It makes this recommendation despite a very low certainty of evidence and it does note both cost and access issues to this monoclonal antibody.


Read the guideline update itself for discussion on the rationale and recommendations for further research on each of these 3 conditional recommendations.





Johnson S, Lavergne V, Skinner AM, et al. Clinical Practice Guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused Update Guidelines on Management of Clostridioides difficile Infection in Adults. Clinical Infectious Diseases 2021; Published: 24 June 2021



Willingham E. Clostridioides difficile: 2 Sets of Guidelines Disagree. Medscape Medical News 2021; July 07, 2021







Kelly CR, Fischer M, Allegretti JR, et al. ACG Clinical Guidelines: Prevention, Diagnosis, and Treatment of Clostridioides difficile Infections. Am J Gastroenterol 2021; 116(6): 1124-1147,_Diagnosis,.12.aspx



Guh AY, Mu Y, Winston LG, et al. Trends in U.S. Burden of Clostridioides difficile Infection and Outcomes. N Engl J Med 2020; 382:1320-1330



Wilcox MH. Updated Evidence for Optimal Management of CDI . IDSE In fectious Disease Special Edition 2019; December 5, 2019



Rao K, Malani PN. Diagnosis and Treatment of Clostridioides (Clostridium) difficile Infection in Adults in 2020. JAMA 2020; 323(14):1403-1404



Cho JM, Pardi DS, Sahil K. Update on Treatment of Clostridioides difficile Infection. Mayo Clinic Proceedings 2020; 95(4): 758-769



Barker AK, Scaria E, Safdar N, Alagoz O. Evaluation of the Cost-effectiveness of Infection Control Strategies to Reduce Hospital-Onset Clostridioides difficile Infection. JAMA Netw Open 2020; 3(8): e2012522



Dunn AN, Radakovich N, Ancker JS, et al. The Impact of Clinical Decision Support Alerts on Clostridioides difficile Testing: A Systematic Review. Clinical Infectious Diseases 2021; 72(6): 987-994 Published online February 15, 2020






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New Blood Management Guidelines for Cardiac Surgery




We’ve done multiple columns on the detrimental effects of red blood cell transfusions and the trend toward more restrictive transfusion guidelines (see list at the end of this column). But most of the recommendations for restricted use of transfusion have applied to non-cardiac surgery.


Now 4 specialty societies (the Society of Thoracic Surgeons, the Society of Cardiovascular Anesthesiologists, the American Society of ExtraCorporeal Technology, and the Society for the Advancement of Patient Blood Management) have collaborated to publish an update to “Clinical Practice Guidelines on Patient Blood Management” (Tibi 2021). The guidelines focus on ways to minimize blood loss during cardiac surgery and reduce the need for transfusions.


The updated guidelines use the term “patient blood management” (PBM) rather than the term “blood conservation” that had been used in the prior guidelines. PBM includes managing anemia, optimizing coagulation, interdisciplinary blood conservation modalities, and patient-centered decision making in order to achieve improved patient outcomes.


The guideline calls for preoperative identification of high-risk patients and use of preoperative and perioperative measures of blood conservation. Assessment of anemia and determination of its etiology is appropriate in all patients undergoing cardiac surgery. Iron deficiency is the most common cause of anemia in this population, occurring in up to 50% of anemic patients. Treating iron-deficiency anemia should be done before surgery if time permits, and can substantially reduce the need for blood transfusion. In patients undergoing cardiac operations, it is reasonable to implement standardized transfusion protocols in order to reduce transfusion burden. Preoperative erythropoietin-stimulating agents and iron supplementation several days prior to cardiac operations to increase red cell mass can be considered in those patients at high risk for postoperative anemia or those who refuse transfusion. Phlebotomy should be minimized by reduced volume and frequency of blood sampling as a reasonable means of blood conservation. The guideline also provides recommendations for preoperative management of any antiplatelet agents or anticoagulants being used, including timing of cessation for individual agents and recommendations regarding reversal agents if needed.


It also has recommendations regarding use of antifibrinolytic agents (and also DDAVP in those patients with conditions known to respond to DDAVP). It provides guidance for various blood products and derivatives.


Red blood cell salvage is emphasized in patients on cardiopulmonary bypass. Centrifugation of pump-salvaged blood is reasonable for minimizing post- cardiopulmonary bypass allogeneic red blood cell transfusion.


Regarding volume replacement, the guideline states it is reasonable to administer human albumin after cardiac surgery to provide intravascular volume replacement and minimize the need for transfusion. But hydroxyethyl starch is not recommended as a volume expander in cardiopulmonary bypass patients because it may increase the risk of bleeding.


Another recommendation is to use “retrograde autologous priming”, in which the cardiopulmonary bypass circuit is primed with the patient’s own blood. That technique has been shown to reduce transfusion rates.


Regarding transfusion strategies, the guideline states “In patients undergoing cardiac surgery, a restrictive perioperative allogeneic red blood cell (RBC) transfusion strategy is recommended in preference to a liberal transfusion strategy for perioperative blood conservation, as it reduces both transfusion rate and units of allogeneic RBCs without increased risk for mortality or morbidity.” It also notes that allogeneic RBC transfusion is unlikely to improve oxygen transport when the hemoglobin concentration is greater than 10 g/dL and is not recommended.


The guideline further recommends that a multidisciplinary team of health care providers should be part of any patient blood management program to limit utilization of blood resources and decrease the risk of bleeding.


Read the full guideline to see grading of the evidence for each of the recommendations and good discussions on the rationale for each.



Prior columns on potential detrimental effects related to red blood cell transfusions:






Tibi P, McClure RS, Huang J, et al. STS/SCA/AmSECT/SABM Update to the Clinical Practice Guidelines on Patient Blood Management. Annals of Thoracic Surgery 2021; Published online: June 30, 2021

(Tibi 2021)





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The New NY State Law on Nursing Staffing



We’ve done many columns supporting improved nursing staffing, not only to make the lives of our dedicated nurses better, but also as a means to improve patient safety. A year ago we reported on NY State legislative activities on this issue (see our September 1, 2020 Patient Safety Tip of the Week “NY State and Nurse Staffing Issues”).


Well, NY State finally did pass legislation on nursing staffing and the bill was recently signed into law by the governor (Reisman 2021, AP Staff 2021).  But it’s not quite what was originally envisioned.


The previously proposed legislation would have mandated specific nurse:patient ratios for various healthcare venues.


The law that was recently enacted creates staffing committees at New York hospitals to assess guidelines for per patient staffing levels. Hospitals will be required to form committees composed of registered nurses, licensed practical nurses, ancillary staff members providing direct patient care, and hospital administrators to form the staffing plans. Plans must be adopted and submitted to the NYS Department of Health by July 1, 2022.


While hospital opposition to mandated nursing staffing issues largely killed prior proposed legislation, the realities created by the COVID-19 pandemic forced the legislature to finally act.


This is certainly a step in the right direction, but we’ll have to take a look in a year to see what sort of staffing plans get approval.




Some of our other columns on nursing workload and missed nursing care/care left undone:


November 26, 2013    Missed Care: New Opportunities?

May 9, 2017                Missed Nursing Care and Mortality Risk

March 6, 2018             Nurse Workload and Mortality

May 29, 2018              More on Nursing Workload and Patient Safety

October 2018               Nurse Staffing Legislative Efforts

February 2019             Nurse Staffing, Workload, Missed Care, Mortality

July 2019                    HAI’s and Nurse Staffing

September 1, 2020      NY State and Nurse Staffing Issues

February 9, 2021         Nursing Burnout






Reisman N. New laws will address staffing levels in New York hospitals. Spectrum News 2021; June 21, 2021



Associated Press Staff. New York Law Gives Nurses a Voice in Hospital Staffing Plans. Medscape Medical News 2021; June 21, 2021





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