What’s New in the Patient Safety World

March 2016



·         Finally…A More Rationale Definition for Sepsis

·         TJC Sentinel Event Alert on Preventing Suicide

·         Guideline for Management of Postoperative Pain

·         Does the Surgical Resident Hours Study Answer Anything?





Finally…A More Rationale Definition for Sepsis



You’ve heard us on our “soapbox” about sepsis several times. We like to point out that 2 significant drivers may have changed the landscape and created a population of “sepsis” that has a lesser mortality rate. CMS data clearly show that a few years back there was a significant change in the number of pneumonia cases and sepsis cases (Lindenauer 2012). The number of pneumonias decreased and sepsis cases increased. Why? Hospitals (often with the help of the third party "clinical documentation programs" that help billing) began using the definition of sepsis that required two of the SIRS criteria in a patient suspected of having infection in order to have a DRG for sepsis. You could have a patient with pneumonia happily pushing his IV pole up and down the hallway who meets those threshold criteria and now gets a label of "sepsis", which of course gets a significantly higher reimbursement than pneumonia. The same research group showed how such coding changes have affected reported mortality rates for both pneumonia and sepsis (Rothberg 2014). They note that such shifts in coding reduce the pneumonia mortality rate (because sicker patients are shifted to the sepsis or respiratory failure diagnosis codes) and also reduce the mortality rate for sepsis (because the newly added patients are less sick than the average sepsis patient).


Also, CMS readmission penalties apply to pneumonia but not to sepsis. So there was additional pressure on hospitals to see if patients met the sepsis "criteria". And, as pointed out in the recent coding impact article (Rothberg 2014) the Surviving Sepsis Campaign may have increased awareness of sepsis, resulting in more patients with pneumonia being coded as sepsis since they met the SIRS criteria requirement.


So it’s a great relief that the new consensus definition of sepsis does away with the SIRS criteria. A consensus panel has arrived at new definitions for sepsis and septic shock, marking the first refinement in definition in over 15 years (Singer 2016). The JAMA article by Singer et al was accompanied by 2 articles describing the consensus process and development of clinical criteria (Shankar-Hari 2016, Seymour 2016) and an editorial (Abraham 2016). There was apparently a unanimous agreement to eliminate use of the SIRS criteria.


In the new definition sepsis is defined as “life-threatening organ dysfunction caused by a dysregulated host response to infection” and the clinical criteria for diagnosis are organ dysfunction represented by an increase in the Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score of 2 points or more. The SOFA score is familiar to those who work in ICU’s and has apparently been a useful predictor of mortality.


Because the SOFA score requires measurement of lab parameters and is most easily calculated in ICU patients, the panel came up with the qSOFA (“quick” SOFA) score to be used in patients outside the ICU to quickly identify patients with sepsis without the need for lab data. The qSOFA is based on 3 criteria:

  (1) a respiratory rate ≥22

  (2) altered mentation (Glasgow Coma Scale score of 13 or less) and

  (3) systolic blood pressure ≤100 mm Hg.


The new definition for septic shock requires:

  (1) hypotension not responsive to fluid resuscitation

  (2) requiring vasopressors to maintain a mean arterial BP  ≥65 mm Hg, and

  (3) serum lactate level >2mmol/L (18 mg/dL)


Models show those meeting the new definition of sepsis have an in-hospital mortality greater than 10% and those meeting the septic shock definition have a mortality greater than 40%.


While we applaud the new definition in that it should exclude those cases of mild infections that simply met 2 SIRS criteria, it will likely take some time before the new definition is integrated into ICD-9 or ICD-10 coding. This will obviously complicate measurement in ongoing pay-for-performance programs or public quality reporting programs using sepsis as a parameter. And it may complicate some ongoing research trials. Probably most importantly, it will impact many of the early warning scores we’ve discussed in many of our prior columns on early recognition of sepsis.


One fact we were, frankly, unaware of before this new paper was published is that culture-positive sepsis is observed in only 30% to 40% of cases. Makes you wonder how many more of the cases of “sepsis” under the old definition were actually related to infection.


We still need to focus on early recognition, timely antibiotics and adequate fluid resuscitation to reduce morbidity and mortality from “sepsis”. But hopefully these new definitions are steps in the right direction and will help us determine better management in the future.



Our other columns on sepsis:








Lindenauer PK, Lagu T, Shieh M-S, et al. Association of Diagnostic Coding With Trends in Hospitalizations and Mortality of Patients With Pneumonia, 2003-2009. JAMA 2012; 307(13): 1405-1413




Rothberg MB, Pekow PS, Priya A, Lindenauer PK. Variation in Diagnostic Coding of Patients With Pneumonia and Its Association With Hospital Risk-Standardized Mortality Rates: A Cross-sectional Analysis. Ann Intern Med 2014; 160(6): 380-388




Singer M, Deutschman CS, Seymour CW, et al. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA 2016; 315(8): 801-810




Seymour CW, Liu VX, Iwashyna TJ, et al. Assessment of Clinical Criteria for Sepsis For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA 2016; 315(8): 762-774




Shankar-Hari M, Phillips GS, Levy ML, et al. Developing a New Definition and Assessing New Clinical Criteria for Septic Shock for the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA 2016; 315(8): 775-787




Abraham E. New Definitions for Sepsis and Septic Shock. Continuing Evolution but With Much Still to Be Done (editorial). JAMA 2016; 315(8): 757-759







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TJC Sentinel Event Alert on Preventing Suicide



Acknowledging that suicide is now the 10th leading cause of death in the US, the Joint Commission has just published a new Sentinel Event Alert on “Detecting and treating suicide ideation in all settings” (The Joint Commission 2016). This alert actually replaces two previous Joint Commission Sentinel Event alerts on suicide and differs from the others in that its focus in on detecting suicidal risk factors and suicidal ideation at all levels of the healthcare continuum, not just in hospitals.


While it should be no surprise that we need to focus outside the hospital as well as within, this Sentinel Event Alert is very useful in its links to a host of valuable resources to help with those tasks.


The Joint Commission stresses the importance of detecting and identifying risk factors for suicide since many patients with suicidal ideation may not be overt with that ideation. The alert stresses the following risk factors:


The alert suggests use of a brief, standardized evidence-based screening tool such as the PHQ-9. It notes also the common practice of using the 2-question tool PHQ-2 as an initial screen and moving to the PHQ-9 if the answer to either question is “yes”. The PHQ-9 includes the specific question “Thoughts that you would be better off dead or of hurting

yourself in some way”. If you don’t move on to the PHQ-9 you’d need to add some other assessment for suicidal ideation. The alert notes several other brief screening tools that might be used.


The timing of the alert is good since you’ll recall that the US Preventive Services Task Force just finalized its updated recommendation that screening for depression be conducted in the general adult population, including pregnant and postpartum women (USPSTF 2016a). USPSTF, of course, noted that such screening needs to take place with adequate systems in place to ensure accurate diagnosis, effective treatment, and appropriate follow-up. Similarly, the USPSTF recommends screening for major depressive disorder (MDD) in adolescents aged 12 to 18 years (USPSTF 2016b).


In our March 20, 2012 Patient Safety Tip of the Week “Adverse Events Related to Psychotropic Medications” we noted that many communities are adopting the DIAMOND model (ICSI 2007) for management of depression in the primary care setting. That model is based on the great work from the IMPACT study led by the University of Washington. That approach utilizes the PHQ-9 for both screening and monitoring outcomes, a stepped care approach for treatment modification and intensification, and use of care coordinators embedded in the primary care practices. One of the key elements is a regular interaction with a psychiatrist or other behavioral health provider.


The Joint Commission alert goes on to describe secondary screeners such as the Columbia-Suicide Severity Rating Scale (Posner 2011). The C-SSRS may be found online and has been demonstrated to be valid in several different patient populations (see our December 2011 What’s New in the Patient Safety World column “Columbia Suicide Severity Rating Scale”).


The alert then discusses what to do if a patient screens positive for suicidal ideation but either denies it or refuses treatment. It notes the need to seek corroborating information from secondary sources (such as family, friends, other providers). It specifically states that if a patient declines to consent to such contact, HIPAA permits the clinician to make such contacts without consent if he/she feels the patient may be a danger to self or others.


The alert goes on to describe the immediate steps that must be undertaken to keep the high-risk patient in a safe environment, and steps for lower-risk patients such as providing the phone number of the National Suicide Prevention Lifeline, developing a safety plan, arranging for psychiatric followup within one week, and especially restricting access to firearms or other lethal means (such as drugs or chemicals).


This is where we think the sentinel event alert needs to go further and help communities develop better systems of care. Ironically, we tried for years to get primary care providers to screen their patients for depression, with mixed results. The biggest barrier we encountered was the disruption to the day’s workflow caused when a patient screened positive. Because of that possibility many PCP’s simply refused to do such screening. For that reason we think that organizations like hospital outpatient clinics or accountable care organizations need to have in place lightning response teams so that the PCP can make a single phone call and have a team respond with the capabilities of managing such patients. While we agree with TJC that everyone in the office of a PCP or other provider should be educated on how to deal with potentially suicidal patients, we think it is impractical without the capability of immediately mobilizing other personnel more skilled in dealing with such cases.


The alert goes on to discuss management of the potential suicidal patient by behavioral health professionals, including the need for collaboration with family and other social supports, and development of longer term treatment plans and discharge plans that take into account the very vulnerable period in the weeks or months immediately following discharge from an inpatient facility. They describe mechanisms to deal with patients who do not keep followup appointments. And they discuss the need for detailed documentation of all aspects of care and communication regarding the at risk patient.


Our October 6, 2015 “Suicide and Other Violent Inpatient Deaths noted that, given the nationwide shortage of psychiatrists, getting timely followup arranged can be problematic. The “Zero Suicide” approach, as adopted by NYS Office of Mental Health (NYSOMH 2013), stresses the importance of the “warm handoff” and use of “bridger” staff. The latter are peer specialists who meet with patients either face-to-face or by phone prior to discharge and accompany the patients to their first outpatient appointment. They also ensure that additional appointments are scheduled and educate the patients about other support services.


The Joint Commission sentinel event alert has great references and links to a plethora of great tools, such as those in the national “Zero Suicide” campaign, to help in the management of the potentially suicidal patient.


Overall, this Sentinel Event Alert is a valuable resource. We also encourage you to visit our many previous columns on suicide, the majority of which have been primarily hospital-focused (both behavioral health and general hospitals). But we also encourage you to work with your larger organizational or community partners to think about developing those “lightning response teams” that we think are essential to implementing safety nets that are truly needed to achieve a “Zero Suicide” goal.



Some of our prior columns on preventing hospital suicides:







The Joint Commission. Sentinel Event Alert 56: Detecting and treating suicide ideation in all settings. February 24, 2016




Patient Health Questionnaire-9 (PHQ-9). Developed by Drs. Robert L. Spitzer, Janet B.W. Williams, Kurt Kroenke and colleagues (accessed February 24, 2016)

PHQ-9 (Patient Health Questionnaire-9).




Kroenke K, et al. The Patient Health Questionnaire-2: Validity of a Two-Item Depression Screener. Medical Care 2003; 41: 1284-1294 (accessed February 24, 2016)

PHQ-2 (Patient Health Questionnaire-2).




USPSTF (US Preventive Services Task Force). Final Recommendation Statement. Depression in Adults: Screening. February 2016




USPSTF (US Preventive Services Task Force). Depression in Children and Adolescents: Screening (draft summary). Release Date: February 2016




ICSI. DIAMOND Initiative. Depression Improvement Across Minnesota. 2007




IMPACT. Evidence-Based Depression Care.




Posner K, Brown GK, Stanley B, et al. The Columbia–Suicide Severity Rating Scale: Initial Validity and Internal Consistency Findings from Three Multisite Studies With Adolescents and Adults. Am J Psychiatry 2011; 10.1176/appi.ajp.2011.10111704

Published online November 8, 2011




C-SSRS scales for clinical practice.




New York State Office of Mental Health. Getting to the Goal. Suicide as a Never Event

in New York State. August 2013




Zero Suicide in Heatlh and Behavioral Healthcare. website








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Guideline for Management of Postoperative Pain



New guidelines for management of postoperative pain have just been published jointly by several specialty societies (Chou 2016). The guidelines aim to use multimodal analgesic techniques so that use of opioids might be minimized.


There are 32 specific recommendations in all and the guidelines really focus on multimodal techniques that target different mechanisms of actions in the peripheral and central nervous systems.


Education of the patient should begin preoperatively and be specifically tailored to individual patients, taking into account medical, psychological and social factors. Such preoperative planning may help to reduce opioid consumption, anxiety, requests for sedation and ultimately reduce length of stay. Such educational interventions can range from single episodes of face-to-face instruction or provision of written materials, videos, audiotapes, or Web-based educational information to more intensive, multicomponent preoperative interventions including individualized and supervised exercise, education, and telephone calls. Such sessions should take into consideration health literacy, the language and cultural context of the patient/family, and allow sufficient time for asking questions. Though the timing of such preoperative sessions is uncertain, they should be far enough in advance to allow for discontinuation of certain medications prior to surgery and to avoid withdrawal syndromes from some medications.


The panel does recommend TENS (transcutaneous electrical nerve stimulation) and cognitive behavioral therapy (CBT) as potential nonpharmacologic adjuncts for pain management but found the evidence insufficient to recommend acupuncture, massage, or cold therapy.


The panel recommends use of oral, rather than intravenous, opioids where possible and also recommends avoidance of intramuscular analgesics. Where parenteral analgesia is needed the panel recommends use of intravenous patient-controlled analgesia (PCA) if the patient is a good candidate but recommends against a basal dose of opioids during PCA in opioid-naïve patients.


One overarching theme is use of multiple different analgesics to maximize efficacy of pain control while minimizing adverse effects. The panel recommends that clinicians provide adults and children with acetaminophen and/or nonsteroidal anti-inflammatory drugs (NSAIDs) as part of multimodal analgesia for management of postoperative pain in patients without contraindications and clinicians should consider giving a preoperative dose of oral celecoxib to adult patients if no contraindications. Other pharmacological considerations are use of oral gabapentin or pregabalin, IV ketamine, and IV lidocaine infusions for some procedures.


Other interventions in multimodal pain management may include surgical site-specific local anesthetic infiltration for surgical procedures with evidence indicating efficacy and use of topical local anesthetics in combination with nerve blocks for procedures like circumcision.


Surgical site-specific peripheral regional anesthetic techniques should be considered in adults and children for procedures with evidence indicating efficacy and use of continuous, local anesthetic-based peripheral regional analgesic techniques should be considered when the need for analgesia is likely to exceed the duration of effect of a single injection.


Neuraxial analgesia should be offered for major thoracic and abdominal procedures, particularly in patients at risk for cardiac complications, pulmonary complications, or prolonged ileus. But neuraxial administration of magnesium, benzodiazepines, neostigmine, tramadol, and ketamine should be avoided. Appropriate monitoring should be in place for those receiving neuraxial analgesia.


Each facility performing surgery should have an organizational structure in place to develop and refine policies and processes for safe and effective delivery of postoperative pain control.


There should be access to consultation with a pain specialist for patients with inadequately controlled postoperative pain or at high risk of inadequately controlled postoperative pain (eg, opioid-tolerant, history of substance abuse). And appropriately trained and credentialed physicians should be available for monitoring patients for whom neuraxial analgesia or continuous peripheral blocks are used.


Importantly, there should be adequate education of patients, parents, families, other caregivers and primary care physicians about appropriate tapering of analgesia after discharge from the hospital.


Overall, this is a comprehensive and well thought out guideline that summarizes the evidence from the literature and has practical recommendations for management of postoperative pain.


Also, the American Academy of Pediatrics has recently published its recommendations for critical elements for the pediatric perianesthesia environment (Polaner 2015). It does have a short section on perioperative pain management and has recommendations for monitoring infants whose immature respiratory control centers leave them vulnerable to effects of anesthesia and other drugs and those with obstructive sleep apnea.


Both guidelines do not specify who should provide the preoperative planning and education. The American Society of Anesthesiologists has good discussions on the
Perioperative Surgical Home” and a recent abstract presented at the ASA annual meeting showed how a perioperative surgical home improves quality and reduces costs (Harrison 2015). But, logically, such planning and education should also be multidisciplinary. So a perioperative home staffed by anesthesiologists, nurses, physician extenders, and surgeons from specific departments may make sense. Such might also include pain specialists and clinical pharmacists to help deal with complex cases.







Chou R, Gordon DB, de Leon-Casasola OA, et al. Guidelines on the Management of Postoperative Pain. Management of Postoperative Pain: A Clinical Practice Guideline from the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists’ Committee on Regional Anesthesia, Executive Committee, and Administrative Council. The Journal of Pain 2016; 17(2): 131-157




Polaner DM, Huck CS. AAP (American Academy of Pediatrics). Critical Elements for the Pediatric Perioperative Anesthesia Environment. Pediatrics 2015; 136(6): published online November 30, 2015




ASA (American Society of Anesthesiologists). Perioperative Surgical Home.




Anesthesiology 2015 from the American Society of Anesthesiologists (ASA): Abstract A1031. Presented October 24, 2015

As reported in: Harrison L. Perioperative Surgical Home Improves Quality, Reduces Costs. Medscape Medical News 2015; November 02, 2015








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Does the Surgical Resident Hours Study Answer Anything?



When discussing the impact of healthcare worker fatigue on patient safety, we often begin with the question “Would you rather be cared for by a tired resident who knows you or a wide awake one who doesn’t know you?”. Of course, at this time we don’t have an unassailable answer to that question.


In our many columns (listed below) on the conflicting studies on the impact of housestaff workhour restrictions on patient safety we’ve laid our hopes for better answers on two ongoing randomized trials, one in surgery (the FIRST trial) and one in internal medicine (the iCOMPARE trial).


The results of the FIRST (surgical residency) trial were just published (Bilimoria 2016). But does it really answer critical questions?


The trial concluded that there were no significant differences in the primary or secondary patient outcomes between the standard (ACGME rules) group and the intervention (more flexible hours) group and that there were also no significant differences in residents’ satisfaction with overall well-being and education quality. Residents in the flexible hours arm, however, were more likely to perceive negative effects on personal activities such as time with family and friends, extracurricular activities, rest and health.


The FIRST trial was a well-designed prospective cluster-randomized (at the residency program level) trial that used data from a validated database (the ACS NSQIP database). But it was a noninferiority trial, really designed to show the two arms equal rather than one arm having superior outcomes.


Our biggest problem with the study is that, other than death within 30 days, all the patient level outcomes were likely more related to actions during the surgery or immediate perioperative period. They did not include things like medication errors, which one might reasonably argue would be expected to be more often affected by resident fatigue than would something like wound infections. And we can find no reference in the publication about length of stay or readmission rates, important parameters which often are impacted by both complications and continuity of care issues.


So perhaps the best way to summarize the FIRST results is “there is no difference in patient outcomes or residents’ perception of educational value between strict adherence to ACGME guidelines vs. more flexible workhours but residents have more negative feelings about the impact on their personal lives with the more flexible hours.” Given that, there is actually little reason for the ACGME to alter its recommendations regarding resident work hours.


In the editorial accompanying the FIRST trial results, John Birkmeyer points out that much of the work formerly done primarily by residents is now done primarily by others (Birkmeyer 2016). For example, there are often board-certified intensivists in the ICU’s and many associate providers working with multidisciplinary teams. We’ll add that many hospitals also have hospitalists that are attending to many of the non-surgical aspects of patient care in surgical patients, probably much more so than when the original ACGME resident workhour restrictions were enacted in 2003.


So what did we learn from the FIRST trial? There appear to be no overwhelming reasons that the ACGME workhour restrictions should be rescinded or modified.




Some of our other columns on housestaff workhour restrictions:


December 2008           IOM Report on Resident Work Hours

February 26, 2008       Nightmares: The Hospital at Night

January 2010               Joint Commission Sentinel Event Alert: Healthcare Worker Fatigue and Patient Safety

January 2011               No Improvement in Patient Safety: Why Not?

November 2011          Restricted Housestaff Work Hours and Patient Handoffs

January 3, 2012           Unintended Consequences of Restricted Housestaff Hours

June 2012                    Surgeon Fatigue

November 2012          The Mid-Day Nap

December 10, 2013     Better Handoffs, Better Results

April 22, 2014             Impact of Resident Workhour Restrictions

January 2015               More Data on Effect of Resident Workhour Restrictions

August 2015               Surgical Resident Duty Reform and Postoperative Outcomes

September 2015          Surgery Previous Night Does Not Impact Attending Surgeon Next Day




Some of our other columns on the role of fatigue in Patient Safety:


November 9, 2010      12-Hour Nursing Shifts and Patient Safety

April 26, 2011             Sleeping Air Traffic Controllers: What About Healthcare?

February 2011             Update on 12-hour Nursing Shifts

September 2011          Shiftwork and Patient Safety

November 2011          Restricted Housestaff Work Hours and Patient Handoffs

January 2010               Joint Commission Sentinel Event Alert: Healthcare Worker Fatigue and Patient Safety

January 3, 2012           Unintended Consequences of Restricted Housestaff Hours

June 2012                    June 2012 Surgeon Fatigue

November 2012          The Mid-Day Nap

November 13, 2012    The 12-Hour Nursing Shift: More Downsides

July 29, 2014               The 12-Hour Nursing Shift: Debate Continues

October 2014              Another Rap on the 12-Hour Nursing Shift

December 2, 2014       ANA Position Statement on Nurse Fatigue

August 2015               Surgical Resident Duty Reform and Postoperative Outcomes

September 2015          Surgery Previous Night Does Not Impact Attending Surgeon Next Day



Our previous columns on the 12-hour nursing shift:


November 9, 2010      12-Hour Nursing Shifts and Patient Safety

February 2011             Update on 12-hour Nursing Shifts

November 13, 2012    The 12-Hour Nursing Shift: More Downsides

July 29, 2014               The 12-Hour Nursing Shift: Debate Continues

October 2014              Another Rap on the 12-Hour Nursing Shift

December 2, 2014       ANA Position Statement on Nurse Fatigue

September 29, 2015    More on the 12-Hour Nursing Shift








Bilimoria KY, Chung JW, Hedges LV, et al. National Cluster-Randomized Trial of Duty-Hour Flexibility in Surgical Training. N Engl J Med 2016; published online first February 2, 2016




Birkmeyer JD. Surgical Resident Duty-Hour Rules - Weighing the New Evidence (editorial). N Engl J Med 2016; published online first February 2, 2016






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