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Tag No.: A0500
27000
Based on record reviews and interviews the hospital failed to audit the appropriateness of Fentanyl patch use in 6 out of 6 patients in accordance with hospital policy and procedures and plan of correction. This failure had the potential to expose patients to unsafe Fentanyl Patch use.
Review of the hospital's new (approved and implemented on 11/9/09) policy and procedures regarding Fentanyl Patch Prescribing and Use on 1/5/09 at 2:00 p.m., indicated the following:
1. A pharmacist will retrospectively review 100% of fentanyl patch orders processed.
2. The pharmacist will use the "Fentanyl Patch Audit Tool" to complete the review.
3. The tool will be scanned and linked to the patient profile.
According to hospital records, the pharmacy dispensed Fentanyl patches to six patients between 11/15/09 to 1/4/10.
During interview and record review on 1/5/09 at 9:30 a.m., Staff Pharmacist 1 could not locate the scanned Fentanyl Patch Audit Tool for Patient 1 in Patient 1's computerized profile. Additionally, Staff Pharmacist 1 could not locate Patient 1's original Fentanyl Patch Audit Tool.
During interview on 1/5/09 at 12:15 p.m., the interim director of pharmacy stated the pharmacy staff had not been scanning the Fentanyl Patch Audit Tools into patients' medical record as required per policy. For Patients 1, 3, 4, 5, and 6, the interim director of pharmacy provided the completed Fentanyl Patch Audit Tools, but none of them had been scanned into their computerized profiles. For Patient 2, the hospital staff could not locate a completed Fentanyl Patch Audit Tool. The interim director of pharmacy said he had not been aware that the pharmacy staff had not been following the hospital's policy and scanning the audit tools into patient's profiles. The interim director of pharmacy stated he occasionally looks at the audit tools and was not aware of the missing Fentanyl Patch Audit Tool for Patient 2.
During interview on 1/5/09 at 3:15 p.m., the interim director of pharmacy stated he trained the pharmacists on the new Fentanyl Patch Prescribing and Use Policy during a staff meeting on 11/5/09. According to the meeting's attendance sheet, six out of seven pharmacists attended the meeting. For the seventh pharmacist, the interim director of pharmacy stated he verbally informed the pharmacist of the new policy later since he was not available for the staff meeting. The interim director of pharmacy could not provide an explanation for how the staff's competency was assessed in the new process.
The hospitals plan of correction, accepted on 11/9/09, indicated the following:
1. 100% audit of all fentanyl orders is performed retrospectively by the clinical pharmacist to assure compliance based on established indicators
2. the audit results are presented to the pharmacy director, Pharmacy and Therapeutics committee and Quality Integrated Council.
During interview, the interim director of pharmacy stated that there is no designated "clinical pharmacist" and that different pharmacists rotate into that role depending on the shift. Therefore, it would be possible that the same pharmacist who entered the order would audit it. When asked for the audit results, the hospital staff provided a Fentanyl Patch utilization graph, which showed that for November 2009, seven patients had received Fentanyl patches, and for December 2009, one patient had received Fentanyl Patches. When asked about the number of Fentanyl patch orders received versus the number of Fentanyl Patch orders that were appropriate, the interim director of pharmacy stated that the graph and data represent only the dispensed Fentanyl Patches, not ordered Fentanyl Patches.
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