Stanford Hospital and Clinics has joined the Institute for Healthcare Improvement's (IHI) 100,000 Lives Campaign. Medication reconciliation is one of the IHI's six initiatives. Stanford went one step further with an innovative quality improvement plan to improve patient safety. When compared with intramuscular techniques, research supports the efficacy and patient preference for intravenous patient-controlled analgesia (I.V. PCA) for postoperative pain management. 1 As a result, I.V. PCA is the standard for parenteral opioid administration of pain control after many types of surgery.
Stanford Hospital and Clinics' online adverse event reporting system, Patient Safety Net (PSN), was developed by the University HealthSystem Consortium (UHC), a group of 90 academic health centers, in which Stanford was an early adopter. 2,3 PSN provides a shared database allowing trend analyses and comparisons across the hospital and within the UHC aggregate data. Report information is secure and confidential, and can be submitted anonymously.
Shortly after rolling out the PSN, Stanford's quality managers were startled to discover a recurring problem with one of the most widely used pain management systems: I.V. PCA pumps.
The lost decimal
Patients receiving I.V. pain medications such as morphine or fentanyl frequently use PCA pumps. These bedside devices allow patients to control and self-administer pain medications on an as-needed basis with preset control limits. Patients using PCA have improved pain control and reduced total opiate consumption. 4,5 Approximately 9,000 patients per year receive I.V. PCA at Stanford.
Within 3 months of PSN implementation at Stanford, the system suggested a small but widespread PCA problem. To verify the problem, the quality manager conducted an in-depth, retrospective analysis of 12 months of data, including 9 months of data on paper forms predating the adoption of PSN, and chart reviews. Potential sources of PCA errors which were evaluated included: programming errors resulting in under- or overmedication, human factors resulting in the administration of wrong medications, equipment problems resulting in syringe or machine failures, and ordering or transcription errors. (See "Analysis of 56 incidents over 12 months.")
The analysis confirmed a hospital-wide problem. PCA programming errors were resulting in dosage errors. A typical example was the case of the lost decimal. In this class of problems, a physician might write an order for a 0.5 mg/ml morphine bolus, but the PCA device would be mistakenly programmed for 5 mg/ml. Three-fourths of these errors resulted in overmedication, and one-fourth undermedication, depending on the direction of the misplaced decimal. Not surprisingly, many of the over-medication errors were discovered when the nurse reported that "the patient was very drowsy."
Opportunity for improvement
Stanford's Quality Improvement and Patient Safety Department saw an opportunity to improve patient safety and to decrease near-miss events and medication errors in patients using patient-controlled analgesia. Quality put together a "tiger team" to start a performance improvement project approved by Stanford's Quality Improvement and Patient Safety Committee (QIPSC) and Medical Board. The interdisciplinary team was led by a quality manager and consisted of several pharmacists, nurse managers, staff nurses, a physician, a clinical nurse specialist, and a representative from clinical engineering.
After studying the quality manager's 12-month retrospective review, the PCA team began a failure modes and effects analysis (FMEA), which examines every step of a particular process and identifies possible failure modes, causes, and effects, assigning severity weights and probabilities to each, to generate an overall hazard score. Actions are then developed to mitigate the most hazardous problems. (See "Stanford's PCA failure modes and effects analysis.")
Stanford's PCA FMEA included an examination of the processes for prescribing, dispensing, administering, documenting, and monitoring I.V. PCA. The group identified four areas in need of change to reduce the occurrence of adverse events:
1. Prescribing: The team identified that Stanford didn't use a standard I.V. PCA dosage or concentration protocol. The team also noted that the computerized prescriber order entry (CPOE) system medication order screen lacked an important piece of patient data-the patient's age. Both contributed to dosage errors.
2. Dispensing: Illegibility and the use of ambiguous abbreviations in orders on nursing units without CPOE also contributed to dosage errors.
3. Administration: PCA pumps weren't always programmed correctly, with errors related to inputting the wrong dose, wrong concentration, or wrong rate.
4. Monitoring: The team believed that increased monitoring would further reduce the potential for adverse events among PCA patients.
Action items
The PCA team identified five actions that it believed could reduce the number of errors that occurred in patients with I.V. PCA:
1. Standardize dosage prescribing protocol. To address prescribing errors, the team developed and implemented a hospital-wide standardized dosage-prescribing protocol. The policy also provides an allowance for physician-requested, pharmacy-approved exceptions. To further reduce prescribing errors, Stanford modified its CPOE order screens to include patient age on every screen. The addition of this data provided a further check for dosage appropriateness.
2. Standardize order sets. To address dispensing problems related to legibility and ambiguous abbreviations, the team created standardized, preprinted order sets for PCAs for the paper-based nursing units and a standardized PCA-specific order set for the CPOE system.
3. Double-check policy. To improve the administration of PCA medications, Stanford instituted a double-check policy. This new procedure follows JCAHO National Patient Safety Goal 3 for improving the safety of high-alert medications. 6 Under Stanford's new policy, all programming of I.V. PCA pumps must be independently checked and signed off on by a second RN. These double checks are performed on every PCA change, including syringe changes, changes in rate or dose, and at shift change.
4. Implement nursing protocol. To address the need for improved I.V. PCA patient assessment and monitoring, the team developed and implemented a hospital-wide policy that requires documentation of I.V. PCA patients' respiratory rates every 2 hours and continuous oxygen saturation monitoring. The policy also gave RNs standing orders to administer opiate antagonists for severe respiratory depression or somnolence.
5. Evaluate new equipment. The last major improvement recommended was to determine the feasibility of acquiring newer ("smart") pumps for all patients receiving I.V. PCA medication. These pumps may offer easier programming and a clearer display of settings.
Approval and rollout
Each new change required approval and sign-off by multiple stakeholders. The team recognized that successful implementation of its recommendations would require adequate education and training. For nurse training, the quality manager presented the changes and their rationale to the Stanford Nursing Education Council and on-unit educators. These trainers then communicated the new protocols and double-check policy to all staff. New order sets and protocols were introduced to the physician community through publication in a CPOE update, the pharmacy newsletter, and the medical staff newsletter. Flyers with all of the changes were posted in the physician workrooms on each nursing unit.
Critical process changes were implemented quickly; the complete recommendation set, with the exception of purchasing new PCA pumps (which is now an ongoing project), was implemented within 1 year of PSN's discovery of the problem.
Getting results
The Quality Improvement and Patient Safety Department is continuing to monitor all PSN/PCA events. All PSN events that contain the word PCA are automatically flagged and reviewed with the nurse managers and the pharmacy manager. Findings are reported at the quarterly Nursing Quality Council meeting and to the hospital Quality Improvement and Patient Safety Committee.
Following the implementation of the performance improvement plan, PCA programming errors dropped by 80%.
Online data collection and reporting are crucial for identifying hospital-wide events and trends. Paper-based reporting is inherently slower and more difficult to use to spot low-frequency common events across hospital units. The UHC PSN online adverse event monitoring system answers this need.
PCA-related errors can be significantly reduced through the implementation of a performance improvement plan, like that created and implemented by Stanford Hospital and Clinics, described in this article. Key components of such a plan include special processes of prescribing, dispensing, administering, and patient monitoring, for high-risk medications delivered by PCA devices. Stanford established policies and procedures that provided a standardized dosage protocol, preprinted order sets for PCA patients, and a double-check process for drug administration, documentation of respiratory rates every 2 hours, and continuous oxygen saturation monitoring.
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