We would like to thank all of those who submitted comments on the proposed quality measure being considered by CMS regarding the monitoring of patients using patient-controlled analgesia (PCA) pumps.

In the report submitted by the National Quality Forum to the United States Department of Health and Human Services, the measure was not endorsed and it was decided that the measure “requires modification or further development”. More particularly, the report provides:

MAP received numerous public comments regarding the one measure under consideration, M3040 Appropriate Monitoring of Patients Receiving PCA. Fifteen commenters urged that the measure specifications be modified to require continuous respiratory monitoring for the first 24 hours rather than the current specification of a maximum period not to exceed 2.5 hours between documented respiratory rate, sedation score, and pulse oximetry. A few commenters further indicated specific support for continuous monitoring through one or more of the respiratory monitoring techniques of respiratory rate, ventilation with capnography, and/or oxygenation with oximetry. Conversely, three commenters did not support inclusion of the measure in Hospital Meaningful Use, citing alarm fatigue, inaccuracy of current respiratory monitoring devices, and the need for personalized care for patients nearing the end of life. 

CMS proposed quality measure on patients using patient controlled analgesia requires “further development”

PPAHS asked health experts to provide their opinion on the Proposed Measure, and this is what they told us:

Dr. Frank Overdyk (executive director for research, North American Partners in Anesthesiology, and professor of anesthesiology at Hofstra North Shore-LIJ School of Medicine) explains the importance of PCA in managing pain, but also the need for continuous electronic monitoring of patients:

Spot checks of SpO2, as are commonly taken on med/surg floors, need to be eliminated from patient monitoring practice because these single measurements may mislead a provider into thinking the patient is fine when in fact they may be close to the precipice of unrecoverable respiratory depression. Entering a patient room and placing a pulse oximeter on their finger stimulates their consciousness and respiration sufficiently to falsely elevate their reading, particularly when they are receive supplemental oxygen. Once the provider leaves the room, this stimulus fades and the patient may lapse back into a dangerous level of respiratory narcosis.

Frank Federico (member of the Patient Safety Advisory Group at The Joint Commission, and executive director at the Institute for Healthcare Improvement):

As currently written, the CMS proposed quality measure runs the risk of looking like it is protecting patients, while in reality not going far enough. Although nurse spot checks on patients are advisable, pulse oximetry and capnography are essential risk prevention tools in any pain management plan. The proposed CMS quality measure should include continuous electronic monitoring.”

Matthew Grissinger (director, error reporting programs at ISMP):

The CMS proposed quality measure regarding patient-controlled analgesia deals with a critical patient safety issue that hospitals need to urgently address. Errors with PCA occur and, unfortunately, sometimes with tragic consequences. However, for patients to be safe, we would strongly recommend that the proposed measure to monitor patients using PCA include continuously electronically monitoring them with oximetry for oxygenation and capnography for adequacy of ventilation. In addition, standardization of PCA procedures would greatly reduce PCA errors and adverse events.”

Robert Stoelting, MD (president of the Anesthesia Patient Safety Foundation):

“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.”

Public commenters supported MAP’s conclusion to not endorse Proposed Quality Measure M3040

Below are comments contained in the report that supported continuous electronic monitoring of patients (we apologize if we have missed any comments owing to the length of the report and the difficulty of ascertaining which comments apply to which proposed measure):

Michael J. Range (Cardiopulmonary, Neurology, Sleep Center, Anderson Hospital):

It is my understanding that the proposed standards are set up to require intermittent monitoring of patients on these devices. The clinical evidence seems very clear – post-op patients on PCA pumps, especially patients who may have an Obstructive Sleep Apnea (OSA) component, are at risk, especially in the first 24 hours. 

Considering the obesity epidemic in this country, the numbers of the non-diagnosed OSA patient population is in the millions. As a Registered Respiratory Therapist, and Operational Director of Cardiopulmonary Services, I have witnessed my share of impending and acute respiratory failure in this patient population. Even an “every 15 minute check” does not provide the patient safety that is needed with this population. 

I highly urge that you reconsider the current recommendation and require capnography, pulse oximetry, and heart rate monitoring continuously for the first 24 hours post-operatively when on a PCA pump. 

Michael W. Jopling (Central Ohio Anesthesia, Inc.):

I appreciate the attention that CMS has shown in the proposed Quality Measure #3040 for PCA monitoring. If adopted, this CMS proposed Quality Measure would require hospitals participating in the Medicare program to document respiratory rate, blood oxygenation, and sedation scores at least every 2.5 hours for the first 24 hours in individuals who are on patient controlled analgesia pumps (PCA) longer than 2.5 hours. Please alter this measure so that it applies to all patients receiving parental opioids and to include continuous monitoring of ventilation and oxygenation. If Quality Measure #3040 is not significantly modified, not only will it be ineffectual, but we will lose an opportunity to decrease a significant patient risk. 

I have had significant interest in this area since your 1999 initiative to improve pain management, but that particular proposal had the unintended consequence of increasing risk of opioid induced respiratory depression. Unchecked, the expectation of patients increased, nurses were taught to administer more medication, and physicians were taught to order more medication. Unfortunately, many hospitals saw an increase in sentinel events where the probable root cause was opioid induced respiratory depression. We anticipated this and began an increased monitoring surveillance program utilizing capnography and pulse oximetry which has been quite successful in reducing risk of parenteral opioid respiratory depression. 

During a conference sponsored but the Anesthesia Patient Safety Foundation (APSF) in 2011, I had the opportunity to participate in workshops and hear presentations from individuals that lost loved ones (spouses, children, parents) to opioid induced respiratory depression. None of the individuals that died had significant co-morbidities. The survivors were adamant during the conference that we come forth with solutions that were not targeted only to special or high risk groups so that a similar incident would not be experienced by others. 

Erik Magnusson (DeKalb Regional Medical Center):

I would hope that CMS would consider continuous monitoring of patients while on PCA pumps not just relying on SATs but also Respiratory Rate or ventilation. This would include devices that monitor and record Respiratory Rate, or CO2. Since respiratory rate is the first decrease then CO2 is increased then SAT decreases, it makes sense to monitor respiratory rate or CO2 on a continuous monitor while on PCA pumps or moderate sedation. This way respiratory depression is caught at its earliest time. 

E Frost (Icahn Medical center at Mount Sinai):

Monitoring only SPO2 does not assess adequacy of oxygenation, especially in patients receiving oxygen post op. Also, check q 2.5 hours allow too long a time for hypoxic brain damage to occur…continuous monitoring of ETCO2 and respiratory rate must be added. 

Donna J Scott (Mason General Hospital):

I am concerned about quality measure 3040 if it allows only for spot checking of pulse oximetry when patients are receiving narcotics through a PCA pump. I believe that guidelines that include continuous monitoring by pulse oximetry or capnography would increase our patient’s safety. 

Lenore Alexander (Mothers Against Medical Errors):

Please change measure #3040. Continuous monitoring for post op patients is the only way to ensure these patients do not become part of the growing number of “dead in bed”. It is disgraceful that we even question continuous monitoring in 2013 in The U.S.A/ Dr. Stoelting, president of the Anesthesia Patient Safety Foundation recommends all patients on controlled analgesics be continuously monitored electronically to ensure their safety. 2.5 hours is a long time. I took a 90 minute nap while staying with my 11 year old daughter, in her hospital room after surgery. I awoke to find my child cold and dead next to me. Two hours doesn’t work. Please change this, too many lives will be lost over something very easy to implement. 

Elana B. Lubit (NYU School of Medicine):

Thank you for sponsoring a safety measure for patients on PCA. However, as a practicing anesthesiologist, I believe that spot-checking oxygen saturation is not sufficient. Please revise the measure to allow for continuous oximetry during the initial phase on PCA. 

Tim Vanderveen (San Diego Patient Safety Council):

I am submitting the attachment which contains signatures of members encouraging NQF to support the Anesthesia Patient Safety Foundation’s recommendations for continuous monitoring of all post-operative patients receiving opioids. APSF, the Institute for Safe Medication Practices, the Joint Commission, and the VA Center for Patient Safety have all endorsed continuous monitoring. The San Diego Patient Safety Council, with representation from 17 San Diego area hospitals, currently has undertaken the creation of a community standard for monitoring of patients outside the OR and ICU. The Council members are in unanimous agreement that continuous monitoring of all patients receiving PCA is required to prevent adverse events, and we are working together with this shared goal to create and adopt best practices to improve the safe use of PCA. “The proposed Measure #3040 to ensure the safety of patients using patient-controlled analgesia should include that all patients are continuously electronically monitored for oxygenation with oximetry and/or ventilation with capnography, as recommended by the Anesthesia Patient Safety Foundation.” 

Barbara Gold (University of Minnesota Physicians):

Please adopt measure #3040 to ensure the safety of patients using patient-controlled analgesia by ensuring that all patients are continuously electronically monitored for ventilation with capnography and oxygenation with oximetry, as recommended by the Anesthesia Patient Safety Foundation. 

Peggy Warner (Valley View Regional Hospital):

Recent published studies recommend end title CO2 or capnography as the monitor of choice. Those same studies prove that pulse oximetry alone is not recommended and does not monitor the patient’s ventilation as capnography would. 

For a copy of the letter submitted by PPAHS, please see PPAHS Letter re CMS Proposed Measure.

• Opioid Safety
• Respiratory Compromise