Should Patient Safety Best Practices Be Legislated?

By Michael Wong, JD (Founder/Executive Director, Physician-Patient Alliance for Health & Safety)

Should Patient Safety Best Practices Be Legislated? 

That’s the question that I have been asking myself ever since the Physician-Patient Alliance for Health & Safety was asked to support the Inpatient Opioid Safety Act of 2021(Bill # HR5932) introduced by Representatives Annie Kuster (D-NH) and Tom Emmer (R-MN). This bi-partisan supported legislation seeks to address the national addiction and opioid epidemic by requiring hospitals to continuously monitor all Medicare or Medicaid patients who are administered an opioid regardless of route of administration. Continuous monitoring of such a patient would be required unless such monitoring is contraindicated by the attending physician.

best practices in patient safety = patient monitoring

At the heart of the question “Should Patient Safety Best Practices Be Legislated?” is whether the behavior of people (more specifically, doctors, nurses, and other healthcare professionals) should be mandated by law or whether we should look to educate best practices.

Our legal system mandates all kinds of behavior – killing, stealing, and raping, for example. All of these behaviors, people agree are “bad behaviors” that offenders should be punished for.

However, there are many examples of lesser offenses that have been legislated against. For example, in Singapore, chewing gum is banned, along with “litter, graffiti, jaywalking, spitting, expelling ‘mucus from the nose’ and urinating anywhere but in a toilet. (If it’s a public toilet, you are legally required to flush it.)” 

While some may disagree with this no chewing gum law in Singapore, this disagreement may end when the gum that someone has thrown on the sidewalk gets stuck to the sole of your shoe or the gum that someone has stuck under a chair gets stuck to your pants or dress.

As Martin Lunther King, Jr. said:

Morality cannot be legislated, but behavior can be regulated. Judicial decrees may not change the heart, but they can restrain the heartless. 

The “heartless” regarding chewing gum would be the person who throws the gum on the sidewalk or sticks it under the chair rather than throwing it into a trash can.

Should Continuous Monitoring of Patients Receiving Opioids Be Legislated?

However, to mandate best practices by doctors, nurses, and other healthcare professionals is in a different realm. After all, healthcare professionals have gone through extensive education and training. Shouldn’t that be sufficient?

The Joint Commission thinks it isn’t sufficient. In August 2012, The Joint Commission issued Sentinel Event Alert #49 “Safe use of opioids in hospitals” which said:

While opioid use is generally safe for most patients, opioid analgesics may be associated with adverse effects, the most serious effect being respiratory depression, which is generally preceded by sedation.

The Joint Commission issues Sentinel Event Alerts “because they signal the need for immediate investigation and response.” According to The Joint Commission:

A sentinel event is a Patient Safety Event that reaches a patient and results in any of the following:

  • Death
  • Permanent harm
  • Severe temporary harm and intervention required to sustain life

The proposed monitoring legislation is in agreement with The Joint Commission Sentinel Event Alert #49 “Safe use of opioids in hospitals.” The press release by Representatives Annie Kuster (D-NH) and Tom Emmer (R-MN) discusses why these two members of Congress have come together in bipartisan support for the bill:

“Beyond the threat of addiction, opioid medications can cause serious complications for patients after surgery,” said Rep. Annie Kuster. “Millions of Americans rely on Medicaid and Medicare for treatment, and this bill would modernize post-operative care to prevent opioid-related injury and death. I am proud to introduce this bipartisan legislation, and look forward to working across the aisle to get this over the finish line for patients across the country.” 

 “In an inpatient setting, opioids remain the most commonly used form of pain management,” said Rep. Tom Emmer. “As a result, drug-induced respiratory depression remains a serious safety risk for patients. With the addition of proper continuous patient monitoring, instances like this can easily be detected and avoided. This legislation will ensure patient safety comes first and reduce preventable tragedies from opioid-induced injuries and death.”

In July of 2011, I started the Physician-Patient Alliance for Health & Safety with the mission of improving patient safety and the quality of patient care. PPAHS advocates for best practices and has supported this goal through educational initiatives to encourage the adoption of best practicesSince its inception, PPAHS’s key initiative has been to make sure that all patients receiving opioids are continuously monitored. To further that goal, PPAHS issued the position statement, “Patients Receiving Opioids Must Be Monitored With Continuous Electronic Monitoring.” To read the PPAHS position statement on continuous monitoring, please click here.

My personal motivation for this was the death of Amanda Abbiehl. I had been asked to speak with students at the University of Notre Dame who were looking to help the Abbiehls.

patient safety=patient monitoring

18-year old Amanda Abbiehl tragically died in 2010 at Saint Joseph Regional Medical Center in Mishawaka, Indiana. Amanda was admitted to a hospital for an infection and was hooked up to a PCA pump to manage her pain. Less than twelve hours after Amanda was put on a PCA using Delaudid she was found unresponsive. Amanda’s parents believe that, had Amanda been monitored with capnography and pulse oximetry, nurses would have been alerted that she was in trouble and been able to intervene.

The cause — a PCA (patient-controlled analgesia) pump error. As the petition filed with Indiana’s Patient Compensation Fund states:

“Against her treating physician’s orders, Amanda was given a constant dose of Hydromorphone once she was connected to the PCA pump … Amanda’s family, as well as SJRMC staff, have indicated it took several staff members a long time to program the pump.”

Amanda’s parents, Brian and Cindy, founded A Promise to Amanda Foundation to raise awareness about respiratory depression. 

As Amanda’s father, Brian Abbiehl, told me:

 “My wife and I believe in our hearts and minds that had there been a protocol in place requiring the use of a monitor … she would still be with us today.”

Change Needed in the Way Patients Receive Opioids are Monitored

The Anesthesia Patient Safety Foundation (APSF) has called for a substantial change in the way patients receiving opioids are monitored.

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

patient safety=patient monitoring

Both The Joint Commission and the Anesthesia Patient Safety Foundation advocate for change to prevent adverse events and deaths due to the administration of opioids.

Is a Patient’s Life Worth $30 per Day?

To achieve the paradigm shift that the APSF has espoused is not expensive. It only requires a willingness to implement change.

To get an idea of what it will take to implement these changes, I interviewed Dr. Frank Overdyk for our clinical education podcast, “Preventing Avoidable Deaths.”

Frank Overdyk, MD was an anesthesiologist practicing in Charleston, SC (he is now retired).  He organized the two conferences on opioid-induced respiratory depression for the Anesthesia Patient Safety Foundation. Dr. Overdyk also is a member of the advisory board for the Physician-Patient Alliance for Health & Safety.

During the podcast, Dr. Overdyk said that the costs of monitoring patients was between $20 to #30 dollars per day:

there are estimates that the daily cost of continuous monitoring of a patient for example with a pulse oximetry is on the order of 20 or 30 dollars a day. This does not include the cost implications of staff workflow and some of these other softer costs – indirect costs.

Dr. Overdyk was citing calculations by George Blike, MD, who is Chief Quality and Value Officer at Dartmouth Hitchcock Medical Center. These calculations showed that the average costs for surveillance monitoring is $85 in the first year and then $22 in subsequent years:

Dr. Bilke’s numbers stem from research which he undertook with his colleagues at Dartmouth, “Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study.” This research was prompted by preventable deaths in hospitalized patients, which may be due to unrecognized deterioration.

The Dartmouth researchers implemented a patient surveillance system based on pulse oximetry with nursing notification of violation of alarm limits via wireless pager. After collecting data for 11 months before and 10 months after implementation of the system, they concluded:

Patient surveillance monitoring results in a reduced need for rescues and intensive care unit transfers.

If you – or a loved one, a friend or neighbor – is in hospital, do you think that $22 per day is a reasonable amount to ensure that you do not die?

What are the Costs of not Monitoring a Patient?

Being a lawyer, I also asked myself – what are the costs of not monitoring a patient? What I found was that it costs a lot to defend against preventable adverse events and death:

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

If it’s so easy and inexpensive to monitor patients, why isn’t it being done?”

So, going back to the original question I posed at the beginning “Should Patient Safety Best Practices Be Legislated?” 

I concluded that, yes, PPAHS should support the Inpatient Opioid Safety Act of 2021 to implement patient safety best practices. 

Please Support Best Practices and the Inpatient Opioid Safety Act of 2021

What do you think?

Please support this legislation by contacting your local representative with this short message:

Dear [Representative],

I am writing to ask that you support H.R. 5932, the Inpatient Opioid Safety Act. This legislation, introduced by Representatives Ann Kuster and Tom Emmer, will ensure patient safety comes first and reduce preventable tragedies from opioid-induced injuries and death.


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