Improving Surgical Safety: Time-Outs, Use of Checklists, Systems Improvement

This article in Hospitals and Health Networks provides some interesting insights into successful interventions undertaken by many hospitals to reduce the likelihood of "wrong-sided surgeries" - an event so infrequent, that it is hard to muster an institution's scant resources to address. However, a number of institutions referenced in this article did exactly that.

One of the most helpful lessons from this article are the reasons that The Joint Commission found as the leading "root causes" for this "never event":

Operating Room

• Lack of intraoperative site verification when multiple procedures are performed by the same provider 
• Ineffective handoff communication or briefing process 
• Primary documentation not used to verify patient, procedure, site and side 
• Site mark(s) removed during prep or covered by surgical draping 
• Time-out process occurs before all staff are ready or before prep and drape occur 
• Time-out performed without full participation 
• Time-outs do not occur when there are multiple procedures performed by multiple providers in a single operative care 

Organizational Culture

• Senior leadership is not actively engaged 
• Inconsistent organizational focus on patient safety 
• Staff are passive or not empowered to speak up 
• Policy changes made with inadequate or inconsistent staff education 
• Marketplace competition and pressure to increase surgical volume leads to shortcuts and variation in practice 

The article also identifies the following interventions that seem to have been effective in different settings:

• Implementation of the WHO "Surgical Safety Checklist" to ensure critical aspects of the impending surgery are reviewed (Safe Surgery 2015) 
• Implementation of "Time-Out" to ensure surgical team synchronization (Minnesota) 
• Improving communication regarding the scheduling of surgeries (AnMed Health Women's and Children's Hospital, SC) 
• Support from Hospital Association and local hospital leadership (South Carolina Hospital Association) 
• Insistence upon use of evidence-based standards (Pennsylvania Patient Safety Authority) 
• "Labor-intensive practices" - including staff support, physician support, meetings, observations, a role for everyone (Lifespan, RI) 

These are great examples of "good-old-fashioned" performance improvement - get leadership involved, create a multi-disciplinary team, measure the critical steps in the process, share the data with staff and medical staff, implement the evidence-base, ensure that not implementing the evidence-base is not an option.
There are many other interventions that can also be implemented to help improve surgical safety. Some of these may not directly impact the likelihood of "wrong-sided surgery", but they can have a major impact in the greater endeavor to make surgery safer.

• Pre-Operative Checklist: Helps to standardize a number of items that need to be in place before a patient is "cleared for surgery", including: 
• Cardiology Evaluation (required in high-risk cases to ensure patient's cardiac condition is appropriately treated prior to surgery) 
• Pulmonary Evaluation (required in high-risk cases to ensure patient's respiratory function is appropriately maximized prior to surgery) 
• Anesthesia Evaluation (identifies risk for complications of intubation, anesthesia, and surgery) 
• Administration of Beta-Blockers (specific medications that can reduce risk of cardiac complications) 
• Pre-Operative Testing, including Labs, EKG (to ensure that there are no latent underlying conditions that need to be treated prior to surgery) 
• Prophylactic Antibiotics (medications to prevent infection) 
• VTE Prophylaxis (medications to prevent blood clots) 
• Plan for Peri-Operative Pain Management (a proactive plan can improve pain control, and post-operative recovery) 
• Post-Operative Checklist: Helps to standardize a number of items that need to be implemented and monitored post surgery, including: 
• Monitoring of Blood Loss and Fluid Status (can be signals of underlying complications) 
• Monitoring of Pain (can be a signal of an underlying complication) 
• Monitoring of Cardiac Rhythm (can alert to underlying cardiac complications) 
• Monitoring of Bowel and PO Status (are signals of overall recovery from surgery) 
• Sepsis Screening Protocol (monitor signs to alert for impending infection) 
• Prophylactic Antibiotics (medications to prevent infection) 
• VTE Prophylaxis (medications to prevent blood clots) 
• Removal of Foley Catheter within 24 to 48 hours (can reduce the likelihood of a urinary infection) 
• Intra-Operative Pause: 
• The "Time-Out" is a process by which all team members stop what they are doing prior to surgery so that they can all get "into synch". 
• The Intra-Operative Pause similarly provides a break during prolonged procedures so that team members have a chance to "re-synch". 
• Severity of Surgery Assessment: 
• A formal means to improve communication prior to surgery about the potential for complications. 

I'll provide more details about some of these interventions in subsequent blogs.

Medication Errors Affecting 2000 Patients at Lifespan Hospitals: Need to Improve Care Transitions

The issue of medication errors affecting 2000 patients at Lifespan Hospitals in RI is understandably catching the media's and public's attention.

Although the apparent explanation offered by the hospitals is "software error", the article in FierceHealthcare quotes RI State Health Director, Dr. Michael Fine: this represents a "risk in the handoff process" and requires a "more robust team approach for care transitions".

It may be a relatively subtle mistake that was made - substitution of time-release medications for shorter acting formulations, however, a robust "care transitions process" that the article alludes to could have provided a safety net to catch mistakes made by a software glitch:

• At the time of discharge, it is a common expectation at US hospitals that a formal "medication reconciliation process" be undertaken. 
• Many, if not all, hospitals struggle with medication reconciliation due to the complexity of the task. 
• However, the minimum requirement that all institutions should be able to uphold is that the physician discharging the patient review all discharge medications explicitly, and indicate whether each should be continued or not. 
• The nurse discharging the patient should also review the medications ordered by the discharging physician, providing a "double-check" of the medication reconciliation process. 
• Prior to discharge, the discharging nurse (or delegate) should review the discharge medication list with the patient in order to ensure that the patient understands which medications to take and the indication for each.  
• While many patients may not be in a position to question a subtle substitution of formulations, the aware patient and/or representative family member can often be a "triple-check" in the medication reconciliation process. 
• Subsequent to discharge, the patient's primary care physician and visiting nurse (if involved) should review the discharge medication list to ensure clarity regarding each medication prescribed. 
• These clinicians may be at a disadvantage at determining which medications may not be appropriate since they were not involved in the inpatient care, however, their astute judgment can be a "fourth check" to protecting patient safety. 
• The corollary discharge documents - usually a discharge summary, medication list, and "referral form" - should be completed in a timely manner by the inpatient clinicians and communicated reliably from the hospital to the outpatient care providers. These documents can provide an essential link in the communication chain to ensure safe patient care. 

For an error not to be caught by any of these "safety mechanisms" does imply that there are more serious issues than a software glitch, and Dr. Fine is right to identify that the "care transitions" process needs to be carefully reviewed and may need to be redesigned.

Respectful Management of Serious Adverse Events + Daily Safety Check-in

Combine the thinking of: 

• the paradigm proposed by Jim Conway, Frank Federico, Kevin Stewart, and Mark Campbell of the Institute for Healthcare Improvement about a framework for respectful management of serious adverse events in this article from HealthLeaders Media 

with: 

• the concepts proposed in this article from Patient Safety and Quality Healthcare by Carole Stockmeier and Craig Clapper about instituting a "daily safety check-in" 

and you start to get the makings of a powerful real-time and retrospective risk mitigation and patient safety system, which incorporates the following elements:

• Proactive, immediate, and retrospective responsiveness
• Heightened awareness of risk
• Early resolution of problems
• Accountability
• Leadership presence at the frontline
• Involvement of the frontline staff in safety
• Furthering the culture of safety
• Team-based approach to improving safety
• Development of a structured plan for dealing with safety issues
• Structured risk assessment and mitigation

Thanks to the vision and insights shared by the authors above and for their leading the charge to develop a patient safety system we can all be more proud of.

USA Today: Medicare Inspector General - "More tracking of serious errors needed"

Have to applaud this report since reporting and tracking are often the first steps towards improvement:

In an excerpt from the article - "That means that those hospitals ... don't learn from their mistakes, Inspector General Daniel Levinson writes .. No one tracks the effectiveness of policy changes or how the hospitals actually correct mistakes." 

These statements get at the real crux of the matter - serious adverse events are happening everyday throughout the nation's hospitals. However, are we learning and responding appropriately to the same in order to reduce the risk of injury for subsequent patients? 

In addition to reporting and tracking of the errors, we need robust risk mitigation and performance improvement systems to ensure that patient safety is being improved:

• Root cause analysis of these events to get to the incipient causes of the errors.
• Corrective action plans that hospitals are held accountable to in order to ensure that the root causes are mitigated.
• Failure modes and effects analyses (FMEAs) to ensure that we understand all the myriad ways systems can fail.
• Systems redesign to ensure that the culture, workflow, clinical actions, and behavior that led to the error are truly modified.
• Auditing and Monitoring of systems and outcomes to ensure that the intended changes have gone into effect.
• Real-time assessments of adverse events in order to mitigate immediate risk to the patient in front of us - in addition to retrospective analyses or prospective improvements.

As outlined above, many actions can be taken to improve patient safety. Unfortunately, as hospitals continue to be impacted by the recession - reductions in volumes, cut-backs in budgets, and cuts in reimbursement, patient safety staffing and patient safety systems are not as robust as they need to be.  We can mandate more monitoring, reporting, and tracking of errors, but unless we work with hospitals to develop the infrastructure required to build patient safety systems, patients will continue to be harmed by the very systems intended to help them.

Use of Checklists Could Help Improve Transplant Safety

Interesting article in the Boston Globe today about changes being made to the Lahey Clinic Transplant Program after a number of adverse events were noted in patients.

http://www.boston.com/news/science/articles/2011/10/21/lahey_clinic_revamps_transplant_program_after_kidney_failures/?page=1

Obviously hard to know from the outside all of the details of the issues and the actions taken, however, some of the writeup excerpted above alludes to changes that could be addressed by a "checklist" process, such as the simplistic sketch below:

Drs. Peter Pronovost and Atul Gawande have researched and written eloquently about the use of checklists to improve safety in healthcare. Those of us on the administrative and clinical front lines need to heed their recommendations for implementing this relatively simple tool that has the potential to prevent adverse events, improve outcomes, and improve reliability of care.

Performance Improvement Tip of the Day: Improving Performance after a Serious Clinical Adverse Event

A recently published whitepaper by IHI outlines an excellent proactive approach to responding to serious clinical adverse events: http://fb.me/1h1CfU9vm

A robust improvement plan is critical to the response to a serious clinical adverse event. This is often what the patient, family, and/or staff are looking for in order to rebuild confidence in the care, systems, and institution. The issue brings to mind an example of a serious clinical adverse event that I was involved in assessing:

An elderly female patient was seen in the emergency room after falling and hitting her chest. She was admitted for chest pain, "rule out MI". However, multiple rib fractures were missed on the X-rays. She continued to have pain post discharge, and was subsequently readmitted, at which point the rib fracture diagnosis was made. Her second hospitalization was prolonged - complicated by overmedication with narcotics for pain, renal failure, aspiration pneumonia, traumatic lung injury - leading to her ultimate demise in hospital. Family members were distraught about the original "missed diagnosis" as well as several other care coordination issues ("was she being monitored appropriately?", "how could she develop all of these complications in the hospital?").

The hospital conducted a series of root cause analyses on the case - including all of the practioners involved in the care of the patient: Hospitalist, ED MD, ICU MD, General Surgeon, Anesthesia, Nursing. The root cause was determined to be "lack of awareness and systems to diagnose multiple trauma in elderly patients post fall". This was addressed through communication at staff meetings. The Chiefs of respective departments immediately pulled together a "rib fracture protocol" to help clinicians better diagnose and manage patients with low-impact trauma. Other issues identified by the root cause analyses were also tended to: improving pain management in elderly patients by increasing awareness of hospitalists and coordination with pain service; and ensuring adequate monitoring of acutely ill patients by reinforcing monitoring guidelines.

Ultimately it was the conclusion of the hospital staff that this patient's outcome would likely not have changed due to the underlying traumatic injury. However, the patient's family and all staff would have felt more confident if the right systems were in place to ensure that the right care was delivered at each interaction. The improvement plan above went a long way towards ensuring that future patients would receive the required care. The plan was communicated to the patient's family, along with other findings of the root cause analyses, and responses to their other questions. The depth of inquiry, level of transparency, open communication, and approach to improvement all helped to mitigate the family's concerns.