APSF, Capnography, Patient Monitoring, Patient Safety, Patient-Controlled Analgesics, PCA, Post-Operative Monitoring, Postoperative Pain

New CMS Guidance Recommends Monitoring of All Patients Receiving Opioids

By Michael Wong, JD (executive director, Physician-Patient Alliance for Health & Safety)

(This article first appeared in Becker’s Hospital Review.)

On March 14, 2014, CMS issued guidance “Requirements for Hospital Medication Administration, Particularly Intravenous (IV) Medications and Post-Operative Care of Patients Receiving IV Opioids.”

This guidance recommends “at a minimum” [page 19] that hospitals “have adequate provisions for immediate post-operative care, to emphasize the need for post-operative monitoring of patients receiving IV opioid medications, regardless of where they are in the hospital.” [page 1]

In addition and more importantly, the CMS guidance necessitates monitoring for all patients receiving opioids when in hospital:

“Narcotic medications, such as opioids, are often used to control pain but also have a sedating effect. Patients can become overly sedated and suffer respiratory depression or arrest, which can be fatal. Timely assessment and appropriate monitoring is essential in all hospital settings in which opioids are administered, to permit intervention to counteract respiratory depression should it occur.” [page 15]

 What does the CMS guidance mean by “appropriate monitoring“?

Does “appropriate monitoring” mean intermittent assessment, as was recommended in last year’s CMS proposed quality measure (#3040)?

Proposed measure #3040 provided that monitoring needs to be “documented” and the time between documentation must “not exceed 2.5 hours.” This means that a nurse or other caregiver must document the patient’s condition and do this in intervals of not greater than 2.5 hours.

In the report submitted by the National Quality Forum to HHS, the measure was not endorsed and it was decided that the measure “requires modification or further development.”

Robert Stoelting, MD, president of the Anesthesia Patient Safety Foundation, in commenting on proposed measure #3040 said:

“The conclusions and recommendations of APSF are that intermittent ‘spot checks’ of oxygenation (pulse oximetry) and ventilation (nursing assessment) are not adequate for reliably recognizing clinically significant evolving drug-induced respiratory depression in the postoperative period. For the CMS measure to better ensure patient safety, APSF recommends that monitoring be continuous and not intermittent, and that continuous electronic monitoring with both pulse oximetry for oxygenation and capnography for the adequacy of ventilation be considered for all patients.”

 Or does “appropriate monitoring” mean continuous electronic monitoring?

The CMS guidance provides two examples — one from the Institute for Safe Medication Practices and one from APSF — which could suggest that the guidance may be referring to continuous electronic monitoring. For example, the guidance provides the following from ISMP which refers to monitoring for saturation of peripheral oxygen via pulse oximetry and end-tidal dioxide via capnography:


The CMS guidance also refers to APSF recommendations and its recent video on opioid induced ventilatory impairment.


In its 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.

APSF is calling for a paradigm shift in opioid safety. According to APSF’s Dr. Stoelting:

 “It‘s time for a change in how we monitor postoperative patients receiving opioids. We need a complete paradigm shift in how we approach safer care for postoperative patients receiving opioids.”

Could CMS guidance have saved a life?

Following this CMS guidance for monitoring of patients receiving opioids wherever they are in the hospital could have saved the life of 18-year old, Amanda Abbiehl.


Amanda was admitted to hospital for severe step throat. She did not receive surgery. She was placed patient-controlled analgesia to manage her pain, but was not monitored.

As Amanda’s father asks:

“It isn’t standard practice to monitor patients with Capnography. However, if Amanda’s CO2 level had been monitored, wouldn’t this have alerted her caregivers so her life could have been saved?”

By this measure – continuous electronic monitoring with traditional nursing assessment and vigilance – Amanda may still be alive today. For this, CMS should be applauded for its new guidance.

APSF, Capnography, Patient Safety

Adverse Drug Events Discussed at California Hospital Engagement Network

by Sean Power

The Physician-Patient Alliance for Health & Safety recently participated in a webinar hosted through the California Hospital Engagement Network, an organization that brings together hospitals to reduce patient harm by 40% and readmissions by 20% by the end of 2013.

The panel discussion looked at patient stories and best practices for preventing opioid related adverse events. The panelists included:

  • Lenore Alexander, Mothers Against Medical Error;
  • Malinda Loflin, RN, an Oklahoma City medical center
  • Dr. Mark Parmenter, Scripps Health System
  • Debra Fox, Wesley Medical Center, and
  • Michael Wong, Physician-Patient Alliance for Health & Safety.

We’ve summarized the discussion below:

Leah’s Law and Essentials for Safety


Lenore Alexander shared the story of her daughter, Leah Coufal, who was 11 years old when she died following her successful surgery. Leah underwent surgery to repair a condition called pectus carinatum or ‘pigeon’s chest’, a fairly common condition where the sternum protrudes forward caused by an overgrowth of cartilage.

“Leah was not hooked up to any monitors,” Ms. Alexander recently told Katie Couric on the Katie Couric Show, “Shocking Medical Mistakes”.

Lenore shared Leah’s Four Essentials for Safety as she fights for what she calls Leah’s Law: all patients receiving opioids must be continuously electronically monitored. These four essentials are recommended to be used by caregivers to help make patients and their families to be a partner in patient safety.

1. Ensure patients and families are provided information on proper use of the patient-controlled analgesia (PCA) pump.

Patients need to understand that the patient-controlled analgesia (PCA) device delivers a powerful narcotic. The potency of the drug treating the pain can cause oversedation and it is therefore necessary that families do not administer PCA by proxy.

2. Make sure patients and families understand why they must be monitored for safety reasons.

Oversedation can lead to respiratory depression, which might result in cardiopulmonary arrest that can cause anoxic brain damage or even death.

Pulse oximetry monitors oxygen levels in the blood. Capnography measures ventilation to provide the earliest detection of respiratory depression. Oximetry on the finger and the capnography cannula on the nose provide nurses the opportunity to intervene and prevent respiratory arrest.

3. Save yourself some trouble and educate patients and families about monitor readouts.

Capnography machines display readouts on the device at the patient’s bedside. Make sure patients and families know what a normal capnography waveform looks like and what normal blood oxygen saturation levels fall between. A second set of eyes can prevent adverse events and will engage patients and families in the patient safety process.

4. Educate patients and families why alarms sound and what to do when they do sound.

Educating patients and families about the alarms that help to keep them safe means that they can help nurses identify priority alarms based on condition.

Alarms provide an electronic safety net that supports periodic checks by nurses. Educating patients and families about different alarms can help combat alarm fatigue while increasing the likelihood for a positive patient outcome.

A Nurse’s Perspective on Whether Spot Checks Are Sufficient for Patient Safety

Malinda Loflin, RN, a nurse at an Oklahoma City medical center, shared her expert opinion on intermittent checks for patients on PCA pumps. Ms. Loflin shared the story of her father, Robert Goode, who was nine months away from retirement when he died after a successful surgery with no complications.

Melinda Loflin's father, Robert Goode, who died after a successful surgery with no complications.

Mr. Goode had a history of heart problems and sleep apnea requiring CPAP. Within one day after surgery, Mr. Goode was walking the halls and feeling great. The post-operative orders were for a morphine PCA pump and supplemental oxygen. He was not electronically monitored despite his history of heart problems and sleep apnea.

The deterioration timeline of Mr. Goode.

As Ms. Loflin explained, nursing spot checks met the existing standard of care for Mr. Goode. According to the Lippincott Manual of Nursing Practice, respiratory rate, sedation score, and SpO2 should be checked every hour for twelve hours, then every two hours for twelve hours, then every four hours until the dose is increased or discontinued. In other words, nurses should have checked on Ms. Loflin’s father every 2-4 hours after the first twelve hours.

From Ms. Loflin’s perspective, based on her experience as a nurse and as the daughter of a surgery patient, the prevailing standard of care—2-4 hour nurse checks—are NOT sufficient for ensuring the best patient outcomes.

The Anesthesia Patient Safety Foundation (APSF) and the Institute for Safe Medication Practices (ISMP) agree.

“the conclusions and recommendations of APSF are that intermittent ‘spot checks’ of oxygenation (pulse oximetry) are not adequate for reliably recognizing clinically significant evolving drug-induced respiratory depression in the post-operative period.” -Robert Stoelting, MD, President of the APSF

“One reason why it (periodic spot checks by caregivers and pulse oximetry) is not effective is that a ‘periodic check’ and pulse oximetry would only catch an error, not prevent the error.” -Matthew Grisinger, Director, Error Reporting Programs at the ISMP

Ms. Loflin explains that, from a nurse’s point of view, continuous electronic monitoring with pulse oximetry for oxygenation and capnography for ventilation acts as a nurses’ electronic aid and supplements the 2-4 hour spot checks.

She isn’t the only nurse who holds this perspective, either.

“Human vigilance is required but insufficient, continuous electronic monitoring needs to be there to support and back up nurses, and allow them to visit a patient while monitors are continuously assessing other patients for various physiological parameters (such as, oxygenation with pulse oximeter and adequacy of ventilation with capnography).” -Julianna Morath, RN, MS, Chief Quality and Safety Officer at Vanderbilt University Medical Center

Implementing nursing feedback from individuals like Ms. Loflin and Ms. Morath is integral to achieving better clinical outcomes.

Lessons Learned from Implementing the San Diego Patient Safety Council Toolkit

Mark Parmenter, Pharm.D. (System Director, Clinical Pharmacy Services, Scripps Health System) shared his experience putting into action the San Diego Patient Safety Council Toolkit.

The San Diego Patient Safety Council, who PPAHS readers may remember advocated for continuous monitoring to the CMS proposed quality measure on PCA patient safety, consists of multidisciplinary clinicians and healthcare professionals from acute care facilities across Southern California. It is responsible for offering feedback on best practices, process improvement tools, and obtain consensus on specific topics.

In 2009, Scripps won the Institute for Safe Medication Practices (ISMP) Cheers Award for its PCA toolkit and in 2013 it was the recipient of the AAMI & Becton Dickinson Patient Safety Award.

The San Diego Patient Safety Council offered recommendations for orders, datasets, technology, and monitoring for opioid naïve patients so it created the PCA toolkit which is available for download here.

Impact of Continuous Monitoring

Debra Fox, MBA, RRT-NPS from the Wesley Medical Center in Wichita, KS presented a case study on how continuous electronic monitoring for patients receiving PCA reduced the number and severity of adverse events at the 760-bed facility that handles 150-225 patients per month receiving PCA therapy.

Ms. Fox explained that from 2002 to 2007, Wesley Medical Center increased its emphasis on pain management by using opioid treatments more regularly. They witnessed an increase in opioid related adverse drug events (ADE) during this timeframe. In 2009, the hospital introduced a “smart” pump system that included capnography monitoring.

Wesley also developed policies and procedures to monitor all PCA patients and all high-risk patients receiving IV opioids for the first 48 hours. The goals of the program: effective pain management, fewer severe ADEs, and improved patient safety while receiving PCA.

The hospital observed the percentage of severe ADEs fall from 31% in 2010 before implementing EtCO2 monitoring to 6.8% after implementing it that year. In 2011 and 2012, that percentage continued to drop to 3.6% and 1.4%, respectively.

Wesley Medical Center shares their results after implementing a continuous electronic monitoring program.

Wesley Medical Center won the ISMP Cheers Award in 2012 in recognition for its efforts to improve PCA outcomes.

Recent Recommendations for Reducing Opioid Adverse Events

The Physician-Patient Alliance for Health & Safety discussed a number of recommendations for safe opioid use in hospitals.

The Joint Commission’s Sentinel Event Alert 49 on the safe use of opioids in hospitals states:

“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 Alert cites a study showing that most ADEs were due to drug-drug interactions, most commonly involving opioids, benzodiazepines, or cardiac medications. It cites another study showing that 16% of inpatient adverse drug reactions are attributable to opioids.

The Joint Commission concludes:

“Opioid analgesics rank among the drugs most frequently associated with adverse drug events”

The Physician-Patient Alliance reviewed the causes of opioid-related respiratory depression:

  • Lack of knowledge about potency differences among opioids.
  • Improper prescribing and administration of multiple opioids and modalities of opioid administration (i.e. oral, parenteral, and transdermal patches).
  • Inadequate monitoring of patients on opioids.

The average incidence of opioid-related respiratory depression among patients receiving PCA therapy is around 0.5%. Studies about incidence show that this figure ranges from 0.16% to 5.2%.

Thirteen million patients receive PCA annually, meaning that respiratory depression, using the lower 0.16% figure cited above, occurs in 20,800 patients each year; using the higher 5.2% figure, as many as 676,000 patients experience opioid-induced respiratory depression.

It is estimated that 5,200 potentially preventable episodes of respiratory failure take place in the United States every year. Effective monitoring could reduce this number by half.

To assist hospitals in reducing the number of ADEs for patients on PCA pumps, the Physician-Patient Alliance released a PCA Safety Checklist that is available in Microsoft Word check-able format here and can be downloaded as a PDF here.

What has your hospital done to reduce the number of ADEs in its facilities? Leave a comment below.

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