Does CMS’ Proposed Quality Measure on Patient Monitoring Adequately Address Patient Safety?

by Michael Wong

(This article first appeared in Becker’s Clinical Quality & Infection Control.)

CMS is considering a proposed quality measure that would require “appropriate monitoring of patients receiving PCA [patient-controlled analgesia].” This measure seeks to address the high number of errors that occur with PCA, which unfortunately research shows happens all too frequently.

The Pennsylvania Patient Safety Authority recently released its analysis of medication errors and adverse drug reactions involving intravenous fentaNYL that were reported to them.

Researchers found 2,319 events between June 2004 to March 2012 — that’s almost 25 events per month or about one every day. Although one error a day may seem high, their analysis is confined to reports made to the Pennsylvania Patient Safety Authority and only include fentaNYL, a potent, synthetic narcotic analgesic with a rapid onset and short duration of action.

This latest analysis complements earlier research conducted by the Pennsylvania Patient Safety Authority.

“Over the six-year period from June 2004 to May 2010, data collected by Pennsylvania Patient Safety Authority revealed that there were approximately 4,500 reports associated with PCA pumps,” says Tim Ritter, senior patient safety analyst at the Pennsylvania Patient Safety Authority. “Moreover, U.S. Food and Drug Administration’s Manufacturer and User Device Experience database demonstrates that PCA-related device events are three times as likely to result in injury or death as reports of device events involving general-purpose infusion pumps.”

Consequently, the CMS proposed quality measure in calling for monitoring of patients using PCA seeks to address a critical patient safety issue. CMS’ proposal calls for patients to be “documented” at least once every 2.5 hours for “respiratory rate, sedation score and pulse oximetry.”

This CMS proposed measure falls short of recommendations by major healthcare organizations, such as The Joint Commission, in two ways: 1) respiratory rate is measured (how many breaths the patient takes) but not the quality of respirations (how well the patient is breathing) and 2) pulse oximetry is used (how much oxygen is in the blood), but electronic monitoring should be continuous using both pulse oximetry and also capnography (which measures how much CO2 is exhaled).

Measuring for respiratory rate is not enough. The quality of respirations (i.e. the adequacy of ventilation) must also be measured. The Pennsylvania Patient Safety Authority recommends monitoring of patients include “frequent assessment of the quality of respirations (not just a respiratory rate)” [emphasis added].

Moreover, The Joint Commission cautions against relying upon pulse oximetry monitoring alone and the value of also monitoring for the adequacy of ventilation with capnography, “In addition to monitoring respiration and sedation, pulse oximetry can be used to monitor oxygenation, and capnography can be used to monitor ventilation. Staff should be educated not to rely on pulse oximetry alone because pulse oximetry can suggest adequate oxygen saturation in patients who are actively experiencing respiratory depression, especially when supplemental oxygen is being used — thus the value of using capnography to monitor ventilation. When pulse oximetry or capnography is used, it should be used continuously rather than intermittently.”

The Joint Commission, the American Society of Anesthesiologists and the Institute for Safe Medication Practices recommend the monitoring of exhaled CO2 (i.e. the quality of ventilation) with capnography to detect respiratory depression to increase patient safety with pain medication administration.

Frank Federico, a member of the Patient Safety Advisory Group at The Joint Commission, and executive director at the Institute for Healthcare Improvement, explains further, “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.”

Robert Stoelting, MD, president of the Anesthesia Patient Safety Foundation, agrees with this assessment. He says, “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.”

Although CMS’ proposed quality measure on PCA monitoring addresses a significant patient safety issue, the measure would better serve patients by continuously electronically monitoring patients for oxygenation with pulse oximetry and for the adequacy of ventilation with capnography.

3 thoughts on “Does CMS’ Proposed Quality Measure on Patient Monitoring Adequately Address Patient Safety?

  1. If monitoring and assessment are viewed as continuous measures of a continuous process rather than as discontinuous and intermittent we would ensure not only a much greater degree of safety but also prevent morbidity and mortality

  2. Although the CMS proposed quality measure touches on a critical patient safety issue, the CMS measure only pays lip service to patient safety, as it goes against the recommendations of The Joint Commission, the Anesthesia Patient Safety Foundation, ISMP, and the Pennsylvania Patient Safety Authority.

  3. A doctor emailed us this comment on the CMS proposed quality measure:

    I fully agree with Dr. Stoelting. Monitoring quality of
    respirations is subjective. People die from not breathing in well
    under 2.5 hours. The purported proposal is surely not “evidence
    based.” …

    Hospitals resist continuous capnography and oxygen monitoring due to
    the associated short-term expense. The chance of a lawsuit and the
    associated expense seem unlikely enough that it has been a gamble
    most are willing to take. Until they are required to make changes,
    many will not.

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