Capnography, Monitoring Liability and Costs, Patient Monitoring, Patient Safety, Patient-Controlled Analgesics, PCA, Post-Operative Monitoring, Postoperative Pain

PPAHS Joins Anesthesia Patient Safety Foundation in Call for a “Paradigm Shift” in Opioid Safety

by Sean Power
February 19, 2014

“It’s time for a change in how we monitor postoperative patients receiving opioids,” declares Dr. Robert Stoelting, president of the Anesthesia Patient Safety Foundation (APSF). “We need a complete paradigm shift in how we approach safer care for postoperative patients receiving opioids.”

The APSF recently released a video highlighting the conclusions and recommendations that came out of a 2011 conference on opioid-induced ventilatory impairment. You can find the video here.

In the video, APSF states that continuous electronic monitoring of oxygenation and ventilation, when combined with traditional nursing assessment and vigilance, will greatly decrease the likelihood of unrecognized, life threatening, opioid induced respiratory impairment.

The clinical significance continuous electronic monitoring offers is the opportunity for prompt and predictable improvement in patient safety.

According to Lenore Alexander, founder and executive director of Leah’s Legacy, a patient safety organization focused on safe opioid use:

“A monitor would have saved my child’s life. I have made the goal of continuous postoperative monitoring my commitment.

“All that stands between us and universal post op monitoring is the will to require it.”

In the APSF video, health experts warned of the risks of selectively monitoring some patients.

According to Nikolaus Gravenstein, MD, Professor of Anesthesia, University of Florida School of Medicine, APSF Committee on Technology:

“Who should be monitored electronically? I would say any inpatient but certainly any inpatient prescribed narcotics, because if they are prescribed they can be received.”

According to Michael DeVita, MD, Critical Care Medicine, St. Vincent’s Hospital:

“You need to absolutely require a continuous monitoring system if it’s your goal to prevent every possible death. Who should be monitored? Everyone.”

Mark Montoney, MD, MBA, Executive Vice President and Chief Medical Officer, Vanguard Health Systems, also argued that the costs of continuous electronic monitoring should not be an impediment to saving patients’ lives:

“No matter where you set the thresholds, I think you get too many false negatives and false positives. We either get this sense of security that everything is all right, when in fact it may not be. Or, we have these alarms that are going off that eventually our caregivers get desensitized to.

“I would agree with the notion of continuous monitoring. I don’t see the value of intermittent monitoring. I really stop short at talking about high-risk patients because, while we can define them in a category, we’re going to get burned when we try to differentiate because you don’t always know who’s a high-risk patient.

“One of the questions that’s been asked is, ‘Boy, this is going to cost a lot, isn’t it?’ And I say, ‘Can we not afford to do this?’”

The Physician-Patient Alliance for Health and Safety (PPAHS) applauds the APSF for its goal to prevent every possible death and adverse event associated with opioid induced ventilatory impairment and PCA therapy.

Alarm Fatigue, Monitoring Liability and Costs, Patient Monitoring, Patient Safety, Patient Stories, Post-Operative Monitoring, Postoperative Pain

Making the Case for Maximum Alarm Management and Prevention of Alarm Fatigue

By Lynn Razzano, RN, MSN, ONCC (Clinical Nurse Consultant)

17-year old Mariah Edwards went in for a procedure that is performed countless times each year – a tonsillectomy. Recovering after the successful and very routine procedure, she was administered a dose of fentanyl to manage her pain. Although she was monitored continuously electronically, one of the attending nurses admitted on discovery that the monitor was muted for sound.

The settlement: $6 million. But, what really is $6 million to the parents of Mariah Edwards who have lost a child? What is the emotional toll to her nurses and other caregivers?

Mariah Edwards

Healthcare professionals and hospital staff who a habit or even unintentially disconnect monitoring equipment of silence alarms are vulnerable for missing important safety signals from a patient that is detecting potential harm. It should be a well-established clinical fact that continuous monitoring equipment  generate visual and audible alarm signals to alert clinicians for potential changes in their patient’s condition that may require immediate urgent attention. The nature and purpose for ordering and maintaining continuous monitoring are to have a system that provides clinicians with essential information necessary to properly evaluate the patient and make appropriate treatment decisions.

Unfortunately, it has become a well known fact that hospital nationwide are struggling with major safety issues related to alarms and continuous monitoring systems despite the fact that these systems are monitoring key and vital changes in a patient’s physiologic condition. Patient deaths have been mounting at a significant rate due to the syndrome now entitled as “alarm fatigue”. One of the key causes of patient deaths are stemming from “human error” with secondary factors including equipment failure. Human error is really a term for failure to recognize and make a detrimental treatment decision not based on physiologic warnings or precursors of adverse events – such as turning off the volume on a monitor.

The Joint Commission has progressively been monitoring this issue of clinical alarms which has become a serious situation that requires immediate remedial attention. The Joint Commission has had to progressively develop new National Patient Safety Goals which target and address clinical alarm systems. This new NPSG is effective January 1, 2014 and targets the development of an Alarm Management Program that is articulated, developed by stake holders and implemented as well as continually evaluated for performance improvement initiatives.

The ECRI Institute, since 2008, has initiated a top Ten Health Technology Hazard list and alarms have consistently been at the top of the list. Currently alarms have been elevated to being first on this hazard list due to the criteria of prevalence of the problem as well as severity, deemed “high profile” and whether there are potential solutions for improvement. Alarm hazards score high on the above criteria which means alarm safety should be at an all time high priority for patient safety initiatives in all hospitals.

High volume risk points contribute to alarm and monitoring adverse events including the phenomena called “alarm fatigue”, communication errors, including breakdowns and barriers, consistent training issues/competencies and lastly equipment failure. It has been documented that alarm fatigue is one of the most common contributors to alarm failures and patient harm. Staff working in high volume alarm areas often becomes neutral or desensitized to the number of alarms which results in delayed response error deterrent or poor judgment and missed alarms. All of these factors contribute to an escalation of patient adverse events resulting in harm and adversely effecting the promotion of a safe care environment.

The need for the development of evidenced based criteria for alarm safety, and prevention of alarm fatigue and failure to respond, is increasingly important consideration that can no longer be ignored. A key answer would be the development of a multidisciplinary team with stakeholders that have vested interest in reviewing trends and developing critical thinking clinical protocols/role expectations when taking care of continuously monitored patients.

The goal of the developed protocols should clearly identify:

  • Who is responsible for alarm notification and response.
  • Appropriate hands off communication.
  • Trending, analyzing , and measuring, in real time, all potential alarm related problems including “near misses”.
  • Building the culture of safety and having upper management that have the “buy-in” to maximize the safety movement within their respective institutions.
  • Defining the criteria and decision tree for continuously monitoring a patient when using opioids.

Utilizing the above approach takes a committed quality investment whose patient safety rewards should be clearly acknowledged with periodic review and revision of alarm protocols based on current peer reviewed publications and internal trending data. The investment is well worth the challenge to get to this critical point and requires perseverance to maintain maximum alarm safety.

Alarm Fatigue, Capnography, Infographics, Monitoring Liability and Costs, Patient Monitoring, Patient Safety, Patient-Controlled Analgesics, PCA

INFOGRAPHIC: First National Survey of Patient-Controlled Analgesia Practices

INFOGRAPHIC: First National Survey of Patient-Controlled Analgesia Practices

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Capnography, Monitoring Liability and Costs, Patient Monitoring, Patient Safety, Patient-Controlled Analgesics, PCA, Post-Operative Monitoring

New National Survey Finds Patient Safety at Risk Because of Lack of Consistency in Hospital Patient-Controlled Analgesia Practices

Inconsistency in safe practices most likely accounts for large proportion of adverse events and deaths associated with PCA use, says Physician-Patient Alliance for Health and Safety.

The Physician-Patient Alliance for Health and Safety today released the results from a national survey of United States hospitals on the administration of patient-controlled analgesia (PCA).

According to reports made to the Food and Drug Administration between 2005 and 2009, more than 56,000 adverse events and 700 patient deaths were linked to PCA pumps.

“A national survey of hospitals regarding PCA administration has never been conducted despite PCA pumps being linked to such a high number of adverse events and deaths,” says Michael Wong, JD, founder and executive director of the Physician-Patient Alliance.

“On the negative side, the survey reveals that there is a huge cause for concern for patient safety, as there is a great lack of consistency in safety procedures being followed by hospitals across the country,” says Mr. Wong. “This most likely accounts for a large proportion of adverse events and deaths associated with PCA use.”

Mr. Wong continues: “On the positive side, survey findings also show that adverse events have been averted or costs and expenses reduced by hospitals that are continuously monitoring their patients with pulse oximetry and/or capnography. This demonstrates the critical importance of using continuous monitoring as technological safety nets for patients. As well, it also points to a way hospitals may reduce their costs and expenses.”

A copy of the survey results is available for free on the Physician-Patient Alliance website here.

Capnography, Monitoring Liability and Costs, Patient Monitoring, Patient Safety, Patient-Controlled Analgesics, PCA, Post-Operative Monitoring

First National Survey of Patient-Controlled Analgesia Hospital Practices Reveals Patient Safety Concerns and Role of Continuous Electronic Monitoring

The Physician-Patient Alliance for Health & Safety (PPAHS) today announced the release of major patient safety findings of the first national survey of patient-controlled analgesia (PCA) practices presented at the recent Society of Anesthesia and Sleep Medicine (SASM) 3rd Annual Conference held October 10-11, 2013.

According to reports made to the Food and Drug Administration between 2005 and 2009, more than 56,000 adverse events and 700 patient deaths were linked to infusion pumps. One out of 378 post-surgical patients were harmed or died from errors related to infusion pumps that help relieve pain after surgical procedures, such as knee or abdominal surgery.

“A national survey of United States hospitals regarding PCA administration has never been conducted,” says Michael Wong, JD, founder and executive director of the Physician-Patient Alliance.

Those involved with the analysis survey and preparation of the survey report were Michael Wong, JD (Executive Director, Physician-Patient Alliance for Health & Safety), Anuj Mabuyi, PhD (Assistant Professor Department of Mathematics, Northeastern Illinois University), and Beverly Gonzalez, ScM (Biostatistician, Johns Hopkins Bloomberg School of Public Health).

On the negative side, the survey shows a huge cause for concern for patient safety, as there is a great lack of consistency in safety procedures being followed by hospitals across the country. “This most likely accounts for a large proportion of adverse events and deaths associated with PCA use,” says Mr. Wong.

On the positive side, survey findings also show that adverse events have been averted and/or costs and expenses reduced by hospitals that are continuously monitoring their patients with pulse oximetry and/or capnography. This demonstrates the critical importance of using continuous monitoring as a technological safety nets for patients. As well, it also points to a way hospitals may reduce their costs and expenses.

“However, when we looked at the type of smart pump being used at the facilities reporting a decline in adverse events or a return on investment, there was a significant correlation with those using smart pumps with integrated end tidal monitoring,” says Mr Wong. “Those using smart pumps with integrated end tidal monitoring were almost three times more likely to have had a reduction in adverse events or a return on investment when measured against costs and expenses (including litigation costs) that might have been incurred.”

For a pdf handout of the poster presentation made at SASM annual conference, please click PPAHS SASM Handout.

PPAHS plans to release a full copy of the PCA survey report in the next few weeks.

Monitoring Liability and Costs

Near-Miss Data Show Signs of Trouble Outside OR

Anesthesiology News recently published an article “Near-Miss Data Show Signs of Trouble Outside OR“, which discusses the research conducted by Angela Lipshutz, MD, MPH (critical care fellow, University of California, San Francisco School of Medicine) and her colleagues.

Below is the letter to editors of Anesthesiology News from Michael Wong, executive director of the Physician-Patient Alliance for Health & Safety:

The recent article, “Near-Miss Data Show Signs of Trouble Outside OR” (March 2013, page 1) outlines the causative mechanisms associated with near misses in non–operating room situations. The increase in near misses underscores the necessity for increased safety measures.

As the provision of anesthesia outside the operating room increases in frequency, hospitals need to ensure safety strategies are extended beyond the operating room as well. In 2012, the Joint Commission issued Sentinel Event Alert 49 on safe use of opioids in hospitals, which underscores the association of adverse events with use of opioid analgesics. In particular, the Sentinel Event Alert highlights some of the causes for opioid-related adverse events: lack of knowledge about opioid potency, improper prescribing and administration, and inadequate patient monitoring.

These causative issues are consistent with many of the mechanisms uncovered by Dr. [Angela] Lipshutz and her team that indicate that the majority could be fixed by hospitals. However, more importantly, if these causes can be fixed, this leaves open the larger question of the liability of hospitals that know and do not fix. For example, in the Sentinel Event Alert, the Joint Commission cautioned against relying on pulse oximetry alone when it stated, “Staff should be educated not to rely upon pulse oximetry alone because pulse oximetry can suggest oxygen saturation in patients who are actively experiencing respiratory depression … .”

Clinicians need to monitor patients outside of the operating room for hypoxia and hypoventilation to mitigate the risk for respiratory arrest induced by opioid analgesics. In the checklist we recently released, which can be downloaded for free from our website (www.ppahs.org), one recommended step is to electronically monitor patients with both pulse oximetry and capnography.

Many of the causative mechanisms uncovered by Dr. Lipshutz and her colleagues are within the control of hospitals. Does this study and the Joint Commission’s Sentinel Event Alert put hospitals and anesthesiologists and other health care providers and staff who work in them on notice of the issues they should know and fix?

If it doesn’t, I think that it may certainly put lawyers, who represent patients harmed by opioid analgesics, on notice of what they should look for in and the standard of care they will be asking courts to measure health care providers against.

- Michael Wong, JD

Chris Pasero shares her recipe for disaster and advocates for multi-modal pain management programs.
Capnography, Monitoring Liability and Costs, Patient Safety, Patient-Controlled Analgesics, PCA, Post-Operative Monitoring, Postoperative Pain

Patient Safety Experts Share 4 Insights About Safer Opioid Pain Management

by Sean Power

Patient safety experts recently participated in a webinar on reducing adverse drug events and harm associated with postoperative opioid pain management programs. Premier Safety Institute, an organization dedicated to coordinating safety-related activities among national organizations to help improve safety, hosted the webinar.

The panel featured four patient safety experts:

We’ve highlighted four key insights shared by the panel that improve clinical outcomes during pain management and reduce the chance for adverse drug events to occur.

You can download a recording of the webinar here.

1. Multi-modal pain plans provide better pain relief and result in fewer adverse events than opioid-only pain treatment plans.

“There are some underlying problems that I think we need to address that are affecting the way we are managing pain,” says Ms. Pasero. Short length of stay is a primary objective of care. Hospitals are focused on patient satisfaction scores rather than improved patient outcomes. Health care providers start pain management postoperative intervention rather than preoperative planning and there exists a “more is better” mentality with opioid-only treatment plans.

“When someone has some mild pain, we give them opioids. They have a little more pain, we give them more opioids. They have severe pain, we give more opioids. And, of course, at the top of this pyramid is where we see adverse events including patient deaths,” explains Ms. Pasero. “What’s happening nation-wide is a focus on opioid-only treatment plans. This is problematic.”

The Joint Commission’s Sentinel Event Alert highlighted the problem. Ms. Pasero outlined the elements that make up a sentinel event, and referred to what she called a “recipe for disaster”:

Chris Pasero shares her recipe for disaster and advocates for multi-modal pain management programs.

The Alert states that opioid adverse events are among the most common of all adverse drug events. The action plan proposed by TJC: screen for risk (for example, by using tools like the STOP Bang model), build red flags into electronic medical records to prompt respiratory and sedation assessments, use a scale to assess sedation, and adopt multimodal analgesia plans.

“What I think is the most important thing is that we have got to start using multimodal analgesia plans,” says Ms. Pasero. What this means, she explains, is “combining both pharmacologic and non-pharmacologic interventions that can attack more than one underlying pain mechanism. The goal really should be that we are able to provide better pain relief with fewer adverse effects of each of the drugs in the treatment plan than would be possible with a single intervention.”

“This is critical to an action plan: we have to reframe the discussion with patients,” Ms. Pasero says. There exists a misunderstanding that patients have the right to be pain-free. “That is unrealistic,” explains Ms. Pasero. “We’ve got to revisit that, be honest with patients, and reframe the whole discussion.” This conversation should happen ideally before surgery takes place. Ms. Pasero advises that frontline staff discuss with the patients the idea that the purpose of managing pain is to enable them to achieve functional goals. Doing so shifts expectations such that patients become members of the pain management team.

2. Educating patients and families about opioid PCA pumps leads to better clinical outcomes.

Mr. and Mrs. Abbhiel shared their experience as the parents of an 18-year old girl who died in 2010 because she was not adequately monitored with EtCO2, and shared with the audience their four essentials for caregivers to engage patients and their families in improving patient safety when using patient-controlled analgesia (PCA) pumps:

Brian and Cindy Abbhiel share Amanda's four essentials for safety.

“Basically what we’re looking at is the essentials for safety,” says Ms. Abbhiel. “Ensure patients and families are provided information on proper use of PCA pumps,” she explains. “A lot of people don’t realize that these pumps do deliver a powerful narcotic. It tends to be an issue if the patient is administering it or if somebody else pushes the button for the patient.”

Proper patient education about the devices with which they manage their pain is therefore essential to safe care. “That’s why we need to make sure that patients and families understand why they must be monitored for safety reasons,” Ms. Abbhiel continues. She explains that oximetry on the finger and a capnography cannula on the nose will prevent adverse drug events for patients using PCA pumps to manage pain.

Educating patients and families about how to interpret monitor readouts helps frontline staff monitor patients. “Brian and I both have discussed how we wished that we could have seen some warning sign. With capnography, it pretty much puts the warning sign on the machine and alerts the nurses without them having to come in.”

“Our main goal is really monitoring,” says Mr. Abbhiel. “We just want patients to be safe when they’re on an opioid infusion. We think that the technology is there at the present and we just want people to use it so that everyone can be safe.”

3. Respiratory monitoring technology such as capnography and pulse oximetry can aid in patient assessments and prevent serious adverse events.

St. Joseph’s/Candler Hospitals have not had any opioid-related serious adverse drug events over the last eight years in either of the two hospitals it operates. This achievement is impressive, for SJCHS is the largest healthcare system in southeast Georgia with 675 beds and approximately 25,000 annual discharges.

In the two years preceding the implementation of its advanced safety system, SJCHS experienced three opioid-related events with serious outcomes. These events prompted the hospitals to develop a multidisciplinary team to make delivery of the medication safe.

“We looked at issues and we knew that what we needed to correct was we needed to make sure that the programming of the pump itself was being done in a safe manner and also that the monitoring of these patients was being done at the best possible rate and with the best possible method,” explains Mr. Oglesby.

The hospitals used continuous electronic monitoring with capnography and pulse oximetry as part of a wider process for monitoring respiration and preventing respiratory depression. Mr. Oglesby describes the process: “The first thing we [respiratory therapists] look at is always the patient, not the machine, so we assess the patient’s history, we assess what the patient looks like, we look at their trends [for EtCO2, SpO2, respiratory rate, and PCA medication rates.” The respiratory therapist also provides bedside education with patients and families.

In addition to respiratory assessments at the beginning of every shift, SJCHS determined it was important to make sure everybody is on the same page. They developed action steps for nursing staff that included assessing the patient’s ABCs, stimulating the patient if necessary, ensuring the airway is open and that the cannula is in the right place.

“There is also a change in culture with our PCA patients because not only were we able to monitor these patients but we were also able to give them effective pain management,” continues Mr. Oglesby.

Harold Olgesby shares the benefits of continuous electronic monitoring during PCA.

Mr. Oglesby outlines the benefits of the monitoring: “Better pain control, more appropriate pain control, and a safe environment for our patients. Patients tend to have a better outcome.”

4. As many as 50 percent of PCA-related adverse drug events could be prevented with effective monitoring.

“In studies cited by The Joint Commission,” says Mr. Wong, “opioid analgesics rank among the drugs most frequently associated with adverse drug events.” Three causes of opioid-induced respiratory depression include lack of knowledge about opioid potency, improper prescribing and administration of opioids, and inadequate monitoring of patients on opioids.

Michael Wong shares the causes of opioid induced respiratory depression.

“The incidence of opioid-related respiratory depression is anywhere from 0.16% to 5.2% according to studies. If we take the 13 million patients each year who receive patient controlled analgesia, this means that each year up to 676,000 patients will have a PCA adverse event. This number excludes other forms of opioid administration,” explains Mr. Wong.

Dr. Robert Stoelting, President of the Anesthesia Patient Safety Foundation, estimates that as many as 50% of PCA adverse events could be prevented with effective monitoring. Dr. Richard Dutton, Executive Director of the Anesthesia Quality Institute, states, “any published estimate is likely to be only the tip of the iceberg.”

With the goal of reducing adverse events, the Physician-Patient Alliance for Health & Safety developed a PCA Safety Checklist with a working group of patient safety experts. The concise checklist reminds caregivers of essential steps to initiate and continue to assess patient use of PCA.

The PCA Safety Checklist can be downloaded for free here.

What are your recommendations for improving the safety of patients on opioid pain management programs?

PCA errors certainly occur, both in programming and in delivery, but any published estimate is likely to be only the tip of the iceberg.”
Dr Richard Dutton
Executive Director
Anesthesia Quality Institute
APSF, Capnography, Monitoring Liability and Costs, Patient Safety, Patient-Controlled Analgesics, PCA, Post-Operative Monitoring

Reducing Errors by More than 60 Percent: PPAHS Presents at the Northern Regional Respiratory Care Conference

by Sean Power

Last week, the Physician-Patient Alliance for Health & Safety presented two cases in which health care facilities reduced PCA-related adverse drug events with continuous electronic monitoring.

Experts estimate that anywhere from 600,000 to 2,000,000 PCA errors occur each year. As Dr. Richard Dutton, Executive Director of the Anesthesia Quality Institute, states, “PCA errors certainly occur, both in programming and in delivery, but any published estimate is likely to be only the tip of the iceberg.”

PCA errors certainly occur, both in programming and in delivery, but any published estimate is likely to be only the tip of the iceberg.” Dr Richard Dutton Executive Director Anesthesia Quality Institute

PCA errors certainly occur, both in programming and in delivery, but any published estimate is likely to be only the tip of the iceberg.”
Dr Richard Dutton
Executive Director
Anesthesia Quality Institute

Two hospital systems have implemented solutions to reduce the number of PCA errors.

The Veterans Health Affairs Solution: Implement Strong Fixes

The Physician-Patient Alliance discussed an interview conducting by our executive director Michael Wong with Bryanne Patail, Biomedical Engineer with the U.S. Department of Veterans Affairs, National Center for Patient Safety.

In that interview, Mr. Patail explained how fixing processes leads to better patient outcomes: “In looking at fixes, they can be categorized as strong, intermediate, or weak fixes. The strongest fix for PCA pumps is a forcing function, such as an integrated end tidal CO2 monitor that will pause the pump if a possible over infusion occurred. So, healthcare providers should first look at these strong fixes. There they will see the most impact on reducing errors and improving patient safety.”

Mr. Patail estimates that using capnography, which measures in real-time the adequacy of ventilation, could prevent more than 60 percent of adverse events related to PCA pumps.

The St. Joseph’s/Candler Hospitals Story: Entering Their 8th “Event Free” Year

The Physician-Patient Alliance also discussed how St. Joseph/Candler has been opioid adverse event free for more than 8 years.

St. Joseph’s/Candler’s Hospitals is the largest healthcare system in southeast Georgia with 675 beds and approximately 25,000 annual discharges. In less than a two-year period, they witnessed three significant adverse drug events. To address the problem, in 2002, SJCHS began to replace its existing traditional IV pumps with “smart” IV safety systems—PCA pumps with integrated capnography.

SJCHS estimates that at least 471 adverse drug events have been prevented in eight years since implementing capnography. Equally impressive, the hospital estimates it has prevented $4 million in expenses, not including potential litigation costs. This money can go toward other areas of patient care.

After five years, SJCHS saw $2.5 million return on investment. As Ray Maddox and Carolyn Williams reminds audiences in their paper, “Clinical Experience with Capnography Monitoring for PCA Patients” (APSF Newsletter Winter 2012), there can never exist an adequate monetary valuation of a life saved from preventing an adverse drug event.

Preventing PCA Errors at Your Hospital

The Physician-Patient Alliance, in collaboration with clinical professionals, developed a PCA Safety Checklist that reminds caregivers of the essential steps to take to initiate and assess the use of PCA pumps. While the PCA Safety Checklist is not a comprehensive guideline, the document summarizes evidence-based research that helps decision makers reach solutions.

The PCA Safety Checklist has received some praise by healthcare professionals:

Frank Federico, RPh (Patient Safety Advisory Group at The Joint Commission and Executive Director at the Institute for Healthcare Improvement):

Use and adherence with standardized processes for eligible patients leads to better clinical outcomes. The PPAHS PCA checklist lays out essential steps to be taken to initiate patient-controlled analgesia (PCA) with a patient and to continue to assess that patient’s use of PCA. Following these steps will help to increase patient safety and save lives.

“A checklist would help avoid many things that could go wrong with PCA.” –Dr. Elliot Krane, Director, Pediatric Pain Management, Lucile Packard Children’s Hospital at Stanford.

“A checklist would help to avoid simple but recurrent errors in packaging and programming the PCA.” –Dr. Richard Dutton, Executive Director, Anesthesia Quality Institute.

“In practice, checklists serve as a mental reminder of critical steps that we may or may not remember. Therefore, the value of a checklist with regards to PCAs would be to remind us/double check a critical step in the process.” –Dr. Julius Cuong Pham, Department of Emergency Medicine, Department of Anesthesia and Critical Care Medicine, Armstrong Institute for Patient Safety and Quality at Johns Hopkins University School of Medicine.

“The use of a well-constructed checklist that ensures proper procedures are followed in patient-controlled analgesia would enhance patient safety.” –Dr. Andrew Kofke, Co-Director Hospital of the University of Pennsylvania Neurocritical Care Program.

You can download the free pdf version of PCA Safety Checklist here or a “checkable” and changeable word version of the PCA Safety Checklist by going to the top right hand corner of our website http://www.ppahs.org

Researchers calculate that hospitals spend between $2.7 million and $13.5 million on malpractice litigation.
Capnography, Monitoring Liability and Costs

5 Resources on the Costs of Adverse Events

by Sean Power

Patient safety advocates at hospitals sometimes face roadblocks when introducing new safety measures. One approach to overcome these obstacles involves looking at the financial costs absorbed when things go wrong.

An ounce of prevention is worth a pound of cure. This article explores the legal costs associated with adverse events and ways to minimize unnecessary expenses.

1. Reduce litigation costs.

Although most hospital executives know that one avoided medical malpractice case will pay for a particular patient safety measure, these executives often ask how these “soft savings” (i.e. a future possible expense) can be justified in the “hard dollars” world (i.e. paying for the safety measure today).

Each preventable adverse event costs about $8,750, according to the Institute of Medicine. This excludes potential litigation costs, which when included substantially increase the costs of not avoiding adverse events.

Researchers calculate that hospitals spend between $2.7 million and $13.5 million on malpractice litigation.

In “Malpractice Litigation and Medical Costs”, researchers calculated that malpractice litigation accounts for roughly 2-10% of medical expenditures.

According to the American Hospital Association, total expenditures for the 5,724 registered hospitals in 2011 were $773,546,800,000 or an average of $135,140,950 per hospital. This means that each hospital is spending from $2.7 million to $13.5 million on malpractice litigation.

These figures are supported by estimates from the American Medical Association that calculated that it costs $110,000 per case defending claims.

In short, being patient safe can reduce a litigation costs.

2. Learn from best practices.

Courtney Rowan, MD, pediatric critical care fellow at Riley Hospital for Children at Indiana University Health, in Indianapolis, observed the number of blood gas measurements required for mechanically ventilated patients in a pediatric intensive care unit. Dr. Rowan found that capnography decreased the number of measurements required, lowering expenditures by nearly $1 million over a six-month period.

The retrospective study, which looked at year over year number of measurements before and after implementing capnography, showed the number of blood gas measurements fell from 13,171 to 8,070, according to Anesthesiology News. The initial investment in capnography devices cost $112,000 and resulted in a total cost savings of $985,130.

In another case study, St. Joseph’s/Candler Hospitals in Savannah, Georgia had three opioid-related events with patient-controlled analgesia (PCA) resulting in serious adverse outcomes over a two year period. In response, the hospital implemented capnography monitoring. Carolyn Williams, RPh, the hospital’s Medication Safety Specialist, shared the SJC cost-benefit story, which outlines how the hospitals realized a $2.5 million return on investment.

These case studies detail the cost savings from two patient safety initiatives. While you analyze the costs of NOT implementing your patient safety initiative, you may find these case studies useful for finding best practices.

3. Use the Journal of Emergency Medical Services’ information on capnography.

JEMS.com provides information and resources for the emergency medical services community. Experts predict that within the next five years, capnography will become the “staple technology” of an emergency responder’s standard of care, so it may be beneficial to adopt a similar approach.

It is important that doctors set medical standards. As medical standards change, so does legal liability. Continuous electronic monitoring is already endorsed or recommended by The Joint Commission, the Anesthesia Patient Safety Foundation, the Institute for Healthcare Improvement, the Institute for Safe Medication Practices, and the VA Center for Patient Safety, to name a few.

Hospitals need to set their own standards that are in line with recommendations from these organizations before the courts set standards for them. Doing so will minimize exposure to legal risks associated with adverse events.

4. Saying sorry lowers costs.

In 2007, the University of Michigan Health System adopted a new approach to malpractice claims. The approach centers on apologizing and learning when the hospital is wrong, explaining and defending when it is right, and going to court as a last resort. They estimate that their average legal expense per case is down by more than 50 percent since 1997. Malpractice premiums are level despite increases in the hospital’s clinical business.

The U-M Health System approach tries to do the right thing by its own account. When weighing the costs of patient safety programs, consider the decrease in legal fees and litigation costs. A similar do-the-right-thing approach may yield comparable results.

5. Utilize research on the relationship between patient safety and malpractice risk.

The U-M Health System released lessons learned on how nurturing a culture of patient safety lowers malpractice risk that may prove useful in your cost analysis of your patient safety initiatives.

The researchers released more detailed facts about liability claims and costs in the journal Annals of Internal Medicine.

What other resources have you found useful when analyzing the costs of serious adverse events?

Capnography, Monitoring Liability and Costs, Patient-Controlled Analgesics, PCA

5 Questions Answered about Never Events and Patient-Controlled Analgesia Pumps

by Sean Power

What are Never Events?

Never Events are 28 preventable actions or mistakes that should never happen in a health care setting, which include:

  • Patient death or serious disability associated with a medication error (e.g., errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation or wrong route of administration)
  • Intraoperative or immediately post-operative death in an ASA Class I patient (which includes a normal healthy patient)
  • Patient death or serious disability associated with the use or function of a device in patient care, in which the device is used or functions other than as intended

Wikipedia maintains a list all 28 Never Events.

The National Quality Forum in the United States initially compiled the list. Never Events are quite rare, although the consequences of Never Events can be devastating. How often do Never Events happen?

Some states such as Minnesota have mandatory public reporting laws. Many hospitals are not mandated by their states to report Never Events, though, making it difficult to collect precise numbers. According to The Leapfrog Group, Minnesota has averaged around 100 reported Never Events per year.

Researchers from John Hopkins University School of Medicine in Baltimore conducted the first study to calculate a national rate for Never Events, identifying a total of 9,744 paid malpractice settlement and judgment claims for surgical Never Events between 1990 and 2010.

What is being done to prevent Never Events at health care facilities?

The Centers for Medicare and Medicaid Services (CMS) announced in 2007 that Medicare would no longer pay for additional costs associated with Never Events.

In addition, many hospitals voluntarily publicly report Never Events to increase accountability.

According to Lippincott’s Nursing Center, hospitals that successfully prevent Never Events have established cultures of safety. In other words, hospitals act in the safest manner possible regardless of the degree of regulatory supervision—both management and frontline staff adopt high-reliability behavior such as preoccupation with failure, reluctance to simplify interpretation, and deference to expertise, among other acts.

Which Never Events are associated with Patient-Controlled Analgesia Pumps?

Patient-Controlled Analgesia (PCA) pumps were developed to address under-medication problems for patients requiring pain management. PCA pumps permit the patient to self-administer small doses of narcotics after surgery as a method of pain control.

The risk of respiratory depression can be too great for “opioid naïve” patients—patients who have never experienced prior opioid use—and PCA pumps are now only used for patients who have previously used opioids. Despite these (and other) preventative measures, respiratory depression still occurs too frequently, resulting in serious adverse events and negative patient outcomes.

Of the Never Events listed by the National Quality Forum, PCA pumps might be at risk of contributing to patient death or serious disability associated with a medication error (e.g. incorrectly programming the pump) and with the use or function of a device in patient care in which the device is used or functions other than intended (e.g. a patient’s relative administers medication through the PCA pump on behalf of the patient).

Should dead-in-bed syndrome while on PCA pumps be added to the list of Never Events?

Never Events have two common characteristics: they are totally preventable and they result in serious adverse events. Patient deaths caused by respiratory depression while using PCA pumps share these traits. Therefore, dead-in-bed syndrome needs to be added to the list of Never Events.

Experts would agree. In another article on dead in bed syndrome, Dr. Andrew Kofke, Co-Director at the Hospital of the University of Pennsylvania Neurocritical Care Program, says, “we should stop the found dead in bed syndrome. The use of a well-constructed checklist that ensures proper procedures are followed in patient-controlled analgesia would enhance patient safety.”

The PPAHS has also advocated elsewhere on this website that healthcare facilities adopt a PCA safety checklist. Doing so will minimize the likelihood for adverse events to occur.

With continuous end tidal CO2 monitoring of the adequacy of ventilation with capnography and pulse oximetry for oxygenation, nurses are alerted and can intervene before respiratory depression causes serious adverse events. Dead-in-bed syndrome is thus totally preventable and shares the first characteristic of the Never Events list.

Dead-in-bed syndrome can also have devastating or drastic effects, thus sharing the second common trait with the Never Events list. By failing to monitor patients with capnography and pulse oximetry, patients like Amanda Abbiehl and Leah Coufal would not have been found unresponsive and dead-in-bed. These stories prove that respiratory depression can cause serious adverse events with negative patient outcomes, therefore sharing the second characteristic of the Never Events list.

It necessarily follows that dead-in-bed syndrome while on PCA pumps should be added to the list of Never Events, for they share the two key traits that are common to all other Never Events.

Where can I go to learn more about Never Events?

The PPAHS has compiled the following list of resources about Never Events:

AHRQ Patient Safety Network – Never Events

The Agency for Healthcare Research and Quality published a backgrounder on Never Events. People looking for an introduction to the topic will find this AHRQ article helpful.

Preventing Never Events: What Frontline Nurses Need to Know

Lippincott’s Nursing Center explains Never Events and their consequences. The article targets an audience with a nursing background; however, anybody working in the space can benefit from the frontline perspective.

Surgical never events in the United States

The journal Surgery published an article that examines the frequency of Never Events, their costs to the health care system, the outcomes of patients, and the characteristics of providers involved in adverse events. The results of the study may help health care providers create prevention strategies for patients post-op.

What do you think? Should dead in bed syndrome be added to the list of Never Events? Leave your comments below.