What’s New in the Patient Safety World

June 2017



·         Masterpiece: Monitoring for Opioid-Induced Respiratory Depression

·         New CDC Guideline for SSI Prevention

·         Another Way to Verify Checklist Compliance

·         Just Bag It Campaign Success Story




Masterpiece: Monitoring for Opioid-Induced Respiratory Depression



In all our columns on opioid-induced respiratory depression (OIRD) we’ve not come across an article more comprehensive and elegantly written than one in the May issue of the American Journal of Nursing (Jungquist 2017).


Jungquist and colleages put together a document focusing on risk assessment and tailoring monitoring to patient risk, type and route of opioid administration, previous history of opioid use, concomitant treatments, and the surgery or procedure performed. They provide an excellent table of risk factors for OIRD and emphasize the time frames in which OIRD events are most likely to occur.


They discuss the benefits, disadvantages, and barriers encountered in intermittent pulse oximetry, continuous pulse oximetry, capnography, or minute ventilation technology. Most of all, they stress the importance of monitoring a patient’s sedation level, using tools such as the POSS (Pasero Opioid-Induced Sedation Scale) or RASS (Richmond Agitation-Sedation Scale), to help determine when a patient might be prone to OIRD. Also stressed is the importance of assessing level of sedation and response to pain at a time the peak effect of the opioid is expected. And they note that the frequency of monitoring must be tailored to multiple factors rather than being strictly standardized. Importantly, they note the importance of letting the patient and family know the patient will likely be wakened at night for assessment and that this is a critical patient safety need. And they stress the importance of recognizing trends rather than relying solely on single threshold levels.


They stress another point we have often made: there must be guidelines and policies for nurses to prepare and administer naloxone in appropriate circumstances. They describe how naloxone should be administered and what to watch for. (The only thing we did not find in the article was a discussion of the phenomenon of “renarcotization”.)


Jungquist and colleagues are to be commended for this outstanding article.




Our other Patient Safety Tips of the Week pertaining to opioid-induced respiratory depression and PCA safety:








Jungquist CR, Smith K, Nicely KLW, Polomano RC. Monitoring hospitalized adult patients for opioid-induced sedation and respiratory depression Am J Nurs 2017; 117(3 Supp): S27-S35







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New CDC Guideline for SSI Prevention



We’ve had a flurry of updates on guidelines for prevention of SSI’s (surgical site infections). Last year the American College of Surgeons (Ban 2016), the American College of Obstetricians and Gynecologists (Pellegrini 2016), and WHO (Allegranzi 2016a, Allegranzi 2016b) published their updated guidelines. And the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA) published their update in 2014 (Anderson 2014). Now the Centers for Disease Control and Prevention has published it’s new guidelines (Berríos-Torres 2017).


The new CDC guideline focuses heavily on antimicrobial prophylaxis but includes several other salient recommendations:


Antimicrobial Prophylaxis

It recommends that preoperative antimicrobial agents be administered only when indicated based on published clinical practice guidelines and timed such that a bactericidal concentration of the agents is established in the serum and tissues when the incision is made (that includes administration of appropriate parenteral prophylactic antimicrobial agents before skin incision in all cesarean section procedures). It recommended no further refinement of timing for preoperative antimicrobial agents based on clinical outcomes and notes this is an unresolved issue. (Note our comments below on a new study that showed no advantage of earlier vs. later administration).


Interestingly, the CDC guideline makes no recommendation regarding antibiotic dosing either with respect to patient weight or redosing during long procedures. Note that we have often stressed that these two issues should be discussed during the preoperative “huddle” (or “briefing”). The CDC guideline acknowledges that several of the other guidelines do have recommendations about these two issues and provides that information in supplemental form.


Also the guideline recommends against additional prophylactic antimicrobial doses in clean and clean-contaminated procedures after the surgical incision is closed in the operating room, even in the presence of a drain (strong recommendation with high-quality evidence).


Antiseptic prophylaxis

Advise patients to shower or bathe (full body) with soap (antimicrobial or nonantimicrobial) or an antiseptic agent on at least the night before the operative day (strong recommendation; accepted practice) and perform intraoperative skin preparation with an alcohol-based antiseptic agent unless contraindicated (strong recommendation; high-quality evidence). Our comment: don’t forget the risks for surgical fires with alcohol-based antiseptics so proper precautions must be maintained at all times (see our multiple columns on surgical fires).


Glucose control

The CDC guideline recommends blood glucose in the perioperative period with target levels less than 200 mg/dL in patients with and without diabetes.



The CDC guideline recommends maintenance of perioperative normothermia, without endorsing a specific method to be used.


Supplemental Oxygen

Use of supplemental oxygen has long been a controversial issue and one has to weigh any potential benefits against potential risks. But the new CDC guideline does recommend that for patients with normal pulmonary function undergoing general anesthesia with endotracheal intubation, administer increased FIO2 during surgery and after extubation in the immediate postoperative period. To optimize tissue oxygen delivery, maintain perioperative normothermia and adequate volume replacement (strong recommendation; moderate-quality evidence). Note that a meta-analysis by Yang et al. (Yang 2016) found moderate evidence to suggest that administration of high FiO2 to patients undergoing surgery, especially colorectal surgery, reduces the risk of SSI. (Our comment: again keep in mind the risk for surgical fires that a high oxygen environment brings and take appropriate precautions to minimize that risk.)


Perhaps the most striking aspect of the CDC guideline document, as pointed out in the invited commentary (Lipsett 2017), is the sheer number of practices for which there was insufficient evidence to make a recommendation. We also refer you to those other recent guidelines listed in the first paragraph of today’s column.


There have been a few other recent studies relevant to SSI’s. As noted above, a recent randomized controlled trial looked at timing of antibiotic prophylaxis (Weber 2017). Current practice calls for administration of surgical antimicrobial prophylaxis for the prevention of SSI’s within 60 minutes before incision. In this RCT the median administration time was 42 min before incision in the early group and 16 min before incision in the late group (cefuroxime was the antibiotic used in this study). Early administration of SAP did not significantly reduce the risk of SSI compared with late administration. The findings do not support any narrowing of the 60-min window for the administration of a cephalosporin with a short half-life.


The accompanying editorialist (Humphreys 2017) stresses that, though we don’t yet know the optimal timing for prophylactic antibiotics, it is “incumbent on the surgical team, anesthetic team, pharmacist and antimicrobial stewardship program to ensure the that patient receives the first dose of antibiotics during this important 1-hour window”.


Also published recently was a “Consensus Bundle on Prevention of Surgical Site Infections after Major Gynecologic Surgery” (Pellegrini 2016). This bundle was developed by a multidisciplinary team convened by the Council on Patient Safety in Women's Health Care and is organized into four domains: Readiness, Recognition and Prevention, Response, and Reporting and Systems Learning.


Under “Readiness” it stresses establishment of standards for preoperative care instructions and education for women undergoing major gynecologic surgery (such as hysterectomy), including postoperative wound care instructions, delineation of responsibility for every member of the surgical team, standards for temperature regulation (including not only patient normothermia but also ambient operating room temperature), standardization of selection and timing of administration and discontinuation of prophylactic antibiotics, ideally using order sets or checklists, and standards for appropriate skin preparation both preoperatively and postoperatively.


Under “Recognition and Prevention” it stresses assessment of patient risk preoperatively for surgical site infection using criteria that include blood glucose level, BMI, immune status, MRSA, nutritional status, and smoking status.


Under “Response” it stresses intraoperative “Timeouts” to address antibiotic dosage, timing, prophylaxis issues, and patient-specific issues and reassessment of patient risk for SSI based on length of surgery, potential bowel incision, vaginal contamination, and amount of blood loss. And, of course, it stresses postoperative care instructions and education for patients and family/support persons.


Under “Reporting and Systems Learning” we are pleased to see they stress establishment of a “culture of huddles” for high-risk patients. They also note the importance of creating a system to analyze and report surgical site infection data, monitor outcomes and process metrics, collect and share physician-specific surgical site infection data with all surgeons as part of their ongoing professional practice evaluation, and standardize a process to actively monitor and collect surgical site infection data with postdischarge follow-up.


Not included in the CDC guideline is information from a just published study demonstrating the incidence of SSI’s is highly seasonal (Anthony 2017). Basically, warmer weather increases the SSI rate and lower temperatures decrease the rate. SSI incidence is highest in August and lowest in January (rates 26.5% higher in August than January). Utilizing a large national database and average monthly temperatures based on hospital location, the found the odds of a primary SSI admission increased by roughly 2.1% per 2.8°C (5°F) increase in the average monthly temperature. The highest temperature group, >32.2°C (>90°F), was associated with an increase in the odds of an SSI admission of 28.9% compared to temperatures <4.4°C (<40°F). Note that the study did not report whether there is an association between humidity and SSI’s. Our own experience is that OR’s sometimes have difficulty maintaining their OR ambient temperature and humidity within prescribed limits during hot, humid summer months. Since we can’t control the outside temperature, these new data suggest we need to pay more careful attention to maintain OR temperature and humidity within prescribed range limits and to defer surgery in those OR rooms that are not within the range.


And, speaking about assessment for risk of SSI, there was recently published a new simple risk stratification score for SSI’s (Amri 2017). Retrospectively looking at almost 1500 patients treated surgically for colon cancer at Massachusetts General Hospital over a ten year period, they identified the following risk factors as being significant for SSI’s: smoking, alcohol abuse, type 2 diabetes, obesity, surgical durations greater than 140 minutes, and nonlaparoscopic approaches. SSI rates were:

The authors suggest that this simple risk score can be used to stratify patients by SSI risk and identify patients at risk during their postoperative admission, potentially focusing frequent monitoring and more aggressive preventive efforts on high-risk patients.


And on the Ob/Gyn side there was an abstract (Reddy 2017) at the recent ACOG annual meeting which suggested that changing gloves during cesarean section prior to abdominal wall closure may reduce the risk of wound complications in non-emergent cesarean sections. The authors report preliminary findings in their randomized controlled trial and found a significant reduction in a composite of wound complications (seroma, hematoma, wound infection, skin separation of at least 1cm, or other incisional separation or abnormality requiring a bedside procedure) in the glove-changing group compared to the control group (5.9% vs. 12.9%). The intervention is based on the theory that vaginal flora might be transferred to the abdominal area during the procedure. The intervention consisted of the entire surgical team changing gloves prior to abdominal wall closure. This was a relatively small, single-site study but the intervention is quite low-cost. So it will be interesting to see if the results can be replicated in larger multi-site studies.







Ban KA, Minei JP, Laronga C, et al, American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. Journal of the American College of Surgeons 2016; Published online: November 30, 2016




Pellegrini JE, Toledo P, Soper DE, et al. Consensus Bundle on Prevention of Surgical Site Infections after Major Gynecologic Surgery. Obstetrics & Gynecology 2016; Published ahead of print (Post Author Corrections): December 02, 2016




Allegranzi B, Bischoff P, de Jonge S, et al; WHO Guidelines Development Group. New WHO recommendations on preoperative measures for surgical site infection prevention: an evidence-based global perspective. Lancet Infect Dis 2016; 16(12): e276-e287




Allegranzi B, Zayed B, Bischoff P, et al; WHO Guidelines Development Group. New WHO recommendations on intraoperative and postoperative measures for surgical site infection prevention: an evidence-based global perspective. Lancet Infect Dis 2016; 16(12): e288-e303




Anderson D, Podgornny K, Berrios-Torres S, et al. Strategies to Prevent Surgical Site Infections in Acute Care Hospitals: 2014 Update. Infection Control and Hospital Epidemiology 2014; 35(6): 605-627 (June 2014) electronically published May 5, 2014




Berríos-Torres SI, Umscheid CA, Bratzler DW, et al. for the Healthcare Infection Control Practices Advisory Committee . Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg 2017; Published online May 3, 2017




Yang W, Liu Y, Xhang Y, et al. Effect of intra-operative high inspired oxygen fraction on surgical site infection: a meta-analysis of randomized controlled trials. J Hosp Infection 2016; 93(4): 329-338




Lipsett PA. Surgical Site Infection Prevention—What We Know and What We Do Not Know (Invited Commentary). JAMA Surg 2017; Published online May 3, 2017




Weber WP, Mujagic E, Zwahlen M, et al.Timing of surgical antimicrobial prophylaxis: a phase 3 randomised controlled trial. The Lancet Infectious Diseases 2017; published 03 May 2017




Humphreys H. Precise timing might not be crucial: when to administer surgical antimicrobial prophylaxis. The Lancet Infectious Diseases 2017; published 03 May 2017




Amri R, Dinaux AM, Kunitake H. Risk Stratification for Surgical Site Infections in Colon Cancer. JAMA Surg 2017; Published online April 12, 2017




Reddy B, Scrafford J. Effect of Intra-operative Glove-changing During Cesarean on Post-op Complications: A Randomized Controlled Trial. Abstract 12OP. ACOG 2017




Anthony CA, Peterson RA, Polgreen LA, et al. The Seasonal Variability in Surgical Site Infections and the Association With Warmer Weather: A Population-Based Investigation. Infection Control & Hospital Epidemiology 2017; 1 DOI: 10.1017/ice.2017.84







Print “June 2017 New CDC Guideline for SSI Prevention






Another Way to Verify Checklist Compliance



Checklists are great tools for helping ensure that important steps in a variety of patient safety activities are not missed. But checklists are only as good as the degree to which they are complied with, as exemplified in our May 2, 2017 Patient Safety Tip of the Week “Anatomy of a Wrong Procedure”.


We’ve often noted that most facilities have no idea whether their Universal Protocol or Surgical Safety Checklist is being used well. That is because they don’t audit compliance with its use. Even those that think they have good compliance usually rely on self-reporting rather than more objective measurements. We recommend direct observation or use of video recording as ways to assess compliance. The former is obviously subject to the Hawthorne effect. The latter is more effective but many physicians and OR personnel have objected to video recording and few OR’s use it today.


A third way is to use simple audio recording. While audio recording may miss some of the “body language” aspects that may provide important details about communication in the OR, it may still provide insight into how well OR teams are complying with the checklists. A recent study reported use of such an audio audit of use of a Surgical Safety Checklist at a US hospital (Salgado 2016). Whereas a compliance rate was previously reported as 97.6%, the audio-recorded audits revealed a precisely executed checklist only 73.6% of the time.


The Salgado article is useful not only for details about the method of recording but also for the checklist scoring system they developed.


Note that their version of the WHO Surgical Safety Checklist was modified for their own use, as is strongly recommended for any facility using the checklist. So some items on their checklist audit tool may differ from those you might audit at your facility. They audited items from all 3 components of the Surgical Safety Checklist (pre-procedure, just before skin incision or start of procedure, and post-procedure before patient leaves the OR).


Audit of the middle section of the checklist (just before skin incision or start of the procedure) revealed suboptimal compliance with two key items we have stressed before. Confirmation of the procedure with the consent form was only completed in 69% of audited cases. And asking whether essential imaging was required was completed in only 81% of audited cases. We found it somewhat surprising that the question about whether antibiotic prophylaxis has been given within the last 60 minutes was only completed in 80% of audited cases. On the other hand, we were pleased to see that this facility included a question about letting the alcohol prep dry before draping and that compliance with this item was 89%. We were also glad to see the item addressing anticipated surgical specimens and tests was completed in 94% of cases. The item asking whether venous thromboembolism prophylaxis is needed is also a question we think is important (though we usually recommend it as an item to be discussed during the pre-op huddle) but this item was only completed in 55% of audited cases.


Regarding the pre-procedure portion of the checklist, compliance was pretty good regarding the anesthesia check, medication check, and pulse oximetry items. Risk of hypothermia was formally completed in only 52%. The “site marked” item was complete in only 56%. That sounds awfully low, but it is not clear whether this is adjusted for those cases in which site marking is not indicated (eg. bilateral procedures).


Compliance with the post-procedure portion of the checklist was, in general, poor. Several items are of particular concern. One is that labeling of specimens was completed as an item in only 34% (it is not clear from the article whether this might reflect that specimens were not taken in some cases). And only 43% of cases completed the item asking if instrument, sponge and needle counts were complete. And only 22% asked whether any equipment problems needed to be addressed.


They were also able to identify some barriers to communication, such as distractions. Those identified included personal conversations, staff changes, and room setup noise as major distractors. The researchers also looked at whether “quiet” was requested for various parts of the checklist and whether “quiet” was actually achieved. “Quiet” was actually achieved in less than 50% for each section of the checklist and for only 20% for the post-procedure period.


Note that the Surgical Safety Checklist used by Salgado et al. asked for confirmation of the procedure with the informed consent. It did not require confirmation with the H&P. We feel that requiring the latter is equally important since informed consents are not without problem (see our September 10, 2013 Patient Safety Tip of the Week “Informed Consent and Wrong-Site Surgery”). And, as discussed in our May 2, 2017 Patient Safety Tip of the Week “Anatomy of a Wrong Procedure”, it is critical that all participants have actually looked at these primary source documents (the consent and the H&P).


You should refer to the actual article for a description of the audio recording protocol.


The Salgado study is an excellent contribution to patient safety. Every facility should be auditing compliance with their checklists and both the audio format and the scoring tool developed by these researchers could be adapted to almost any facility. We also suspect that the results found in their audit are probably pretty representative of what the majority of facilities will find when they do their own audit.




Some of our prior columns related to wrong-site surgery:

  September 23, 2008 Checklists and Wrong Site Surgery

  June 5, 2007              Patient Safety in Ambulatory Surgery

  July 2007                   Pennsylvania PSA: Preventing Wrong-Site Surgery

  March 11, 2008         Lessons from Ophthalmology

  July 1, 2008               WHO’s New Surgical Safety Checklist

  January 20, 2009       The WHO Surgical Safety Checklist Delivers the Outcomes  

  September 14, 2010 Wrong-Site Craniotomy: Lessons Learned

  November 25, 2008 Wrong-Site Neurosurgery

  January 19, 2010       Timeouts and Safe Surgery

  June 8, 2010              Surgical Safety Checklist for Cataract Surgery

  December 6, 2010     More Tips to Prevent Wrong-Site Surgery

  June 6, 2011              Timeouts Outside the OR

  August 2011             New Wrong-Site Surgery Resources

  December 2011         Novel Technique to Prevent Wrong Level Spine Surgery

  October 30, 2012      Surgical Scheduling Errors

  January 2013             How Frequent are Surgical Never Events?

  January 1, 2013         Don’t Throw Away Those View Boxes Yet

  August 27, 2013       Lessons on Wrong-Site Surgery

  September 10, 2013 Informed Consent and Wrong-Site Surgery

  July 2014                   Wrong-Sided Thoracenteses

  May 17, 2016            Patient Safety Issues in Cataract Surgery

  July 19, 2016             Infants and Wrong Site Surgery

  September 13, 2016 Vanderbilt’s Electronic Procedural Timeout

  May 2017                  Another Success for the Safe Surgery Checklist

  May 2, 2017              Anatomy of a Wrong Procedure



Some of our prior columns on checklists:






Salgado D, Barber KR, Danic M. Objective Assessment of Checklist Fidelity Using Digital Audio Recording and a Standardized Scoring System Audit. Journal of Patient Safety 2016; Published Ahead of Print Post Author Corrections: November 2, 2016







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Just Bag It Campaign Success Story



We described NCCN’s “Just Bag It!” campaign in our December 2016 What's New in the Patient Safety World column “Standardize 4 Safety and Just Bag It!”. The campaign was launched last year by the National Comprehensive Cancer Network (NCCN 2016). Vincristine is a chemotherapy agent intended for intravenous use. Yet since the 1960’s there have been numerous incidents where it has been administered intrathecally or via Omaya reservoirs. The results are disastrous, with patients developing quadriplegia, encephalopathy, and usually death. In 2013 ISMP summarized the literature (ISMP 2013) and noted that virtually all cases involved vincristine being prepared in a syringe and that there were no cases when vincristine was prepared in an IV bag. There are, of course, other contributing factors in such incidents. ISMP noted the following contributing factors: mislabeling of syringes; bringing IV and intrathecal medications into a treatment area together; failing to administer vinca alkaloids in a specialty oncology unit or with only experienced, oriented staff familiar with current operational and clinical standards, procedures, or protocols; administering chemotherapy outside of normal hours; not conducting an independent double check or “time out” before intrathecal medication administration; and incomplete or missing warning labels. But, given that all reported incidents occurred when vincristine was in a syringe, ISMP recommended that vincristine instead by diluted in a minibag for infusion and syringes be avoided.


The Just Bag It! campaign calls for health care professionals to always dilute vincristine in a 50ml mini-IV drip bag and never in a syringe. The campaign comes with Christopher’s Story, the sad story of a patient who died as the result of one of the above vincristine errors. All NCCN member institutions have already adopted this best practice for handling vincristine but the campaign calls on all other oncology providers to do the same.


Researchers from Johns Hopkins presented a poster (Olsen 2017) at the recent Oncology Nursing Society 42nd Annual Congress as described in an NCCN press release (NCCN 2017). Olsen and colleagues described barriers to standardizing vincristine administration in mini-IV drip bags. They noted that many nurses believed the risk of extravasation would be higher when administering via min-bag than when pushing the agent. However, they found zero cases of extravasation among the more than 1,300 mini-bag administrations of vincristine after the practice change.


Instead of pushing the medication through a syringe, in the new technique the nurse holds the mini-bag as it runs through the side port of a free flowing line. Understanding the rationale for the new practice and becoming familiar with the technique were critical. Nurses received training that included background on the reasons for the switch, watched a video of the technique, and had hands-on training in a skills lab to ensure proper technique before going live with this practice change.


We hope that all sites administering vincristine, not just NCCN member institutions, will use the techniques that are part of the Just Bag It! Campaign. Following the recommendations in the Olsen study should help you in your implementation.






NCCN (National Comprehensive Cancer Network). Just Bag It: The NCCN Campaign for Safe Vincristine Handling. NCCN 2016; accessed November 14, 2016




ISMP (Institute for Safe Medication Practices). Death and neurological devastation from intrathecal vinca alkaloids: Prepared in syringes = 120; Prepared in minibags = 0. ISMP Medication Safety Alert! Acute Care Edition. September 5, 2013




NCCN (National Comprehensive Cancer Network). In Oncology Nursing, One Small Change Can Potentially Prevent Deadly Medical Error in Thousands of Patients. Press Release May 1, 2017




Olsen M, Benani D, Przybylski A, Carrol S, Szabo K. Putting an Old Oncology Nursing Practice to Bed: A Hospital-Wide Initiative Using Evidence-Based Practice to Standardize the Administration of Vinca Alkaloids Using a Minibag, Side-Arm Technique. Oncology Nursing Society 42nd Annual Congress. Poster 187. May 5, 2017







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Print “June 2017 What's New in the Patient Safety World (full column)

Print “June 2017 Masterpiece: Monitoring for Opioid-Induced Respiratory Depression

Print “June 2017 New CDC Guideline for SSI Prevention

Print “June 2017 Another Way to Verify Checklist Compliance

Print “June 2017 Just Bag It Campaign Success Story





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