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Based on review of facility policy, medical record (MR), and staff interview (EMP), it was determined the registered nurse failed to identify a home transdermal Fentanyl patch (a narcotic pain patch) through the initial registered nurse assessment and medication reconciliation on the medical/surgical unit; and additional nursing staff failed to remove the home transdermal patch prior to placement of a new Fentanyl patch in one of 11 medical records reviewed (MR1).

Findings include:

Review on February 26, 2018, of the facility policy "Assessment of the Patient Throughout Hospitalization," last reviewed January 15, 2018, revealed "Purpose: The purpose of this policy is to: Delineate the role responsibilities of the RN and the LPN during the process of assessment that is based on the scope of practice standards. Define timeframe and guideline for system assessment and reassessment ... RN Physical Assessment/ Reassessment: RN is assigned to supervise and evaluate the nursing care furnished to each patient. The data collection will be obtained by an LPN or an RN. An RN assessment will be completed at key times that include, but not limited to: Within 24 hours of admission and at least daily thereafter ... Deterioration in condition and response to treatment. At time of transfer by accepting unit. Day of discharge."

Review on February 26, 2018, of the facility policy "Medication Reconciliation Guidelines," last reviewed March 13, 2016, revealed "Purpose: Accurately and completely reconcile medication across the continuum of care. Policy: 1. Identify ALL medication taken by the patient (including prescriptions, patches, inhalers, eye drops, OTC [over the counter], herbals, and supplements). 2. Information will be gathered at point of entry to health care facility. 3. Review and update of patient's medication list 1. Inpatient: Any licensed personnel can review and update the patient's medication list. ... 6. Medication Reconciliation will be completed at time of admission to the unit, transfer due to change in patient condition, discharge or change of service ... Inpatient Process: Admission: 1. Each time the patient enters the health system site, the patient's medications will be reviewed and recorded in EPIC (the facility's electronic medical record), with all changes being documented. The medication history is updated throughout the hospitalization in the provider rounding navigator .... Transfer: 1. When a patient is being transferred to a different level of care or service, all medications must be reviewed at the completion of the actual transfer process ... 3. All medications that the patient was on prior to transfer MUST be accounted for post-transfer, either by re-ordering those medication post-transfer or documentation in the chart as to why the medications are no longer needed. 4. The home medication list are reconciled with the post-transfer orders. Medications that were not ordered prior to transfer may need to be ordered after the transfer, based on the patient condition ... Discharge: ... 4. The discharge instruction form is completed by the ordering provider. Then 2 copies are printed out by the UDC (unit desk clerk) or nurse. The patient keeps one copy. The other copy is signed by the patient and placed in the paper chart (later to be scanned into the electronic health record)."

Review on February 26, 2018, of the facility policy "Specific Procedures for Administering Medications," last reviewed September 8, 2017, revealed "Purpose: The Specific Procedures for Administering Medications policy establishes guidelines for administration of medications. ... Miscellaneous ... 4. Administration of Topical Patches- see package insert for specific instructions. ..."

Review of the Fentanyl package insert instructions provided by the facility on February 27, 2018, revealed a two-page document which stated "Duragesic (Fentanyl Transdermal System) for transdermal administration ... Dosage and Administration ... Each transdermal system is intended to be worn for 72 hours.

Review of the full prescribing information revealed the following additional information: "2.6 Administration of Duragesic Duragesic patches are for transdermal use only. ... Each Duragesic patch may be worn continuously for 72 hours. The next patch is applied to a different skin site after removal of the previous transdermal system. ..."

Review of MR1 on February 26, 2018, at 10:30 AM revealed the patient arrived at the hospital through the Emergency Department (ED) on January 8, 2018, at 10:51 PM with a chief complaint of increased confusion. The emergency medicine note indicated the last dose of Fentanyl 75 mcg patch was January 7, 2018, at an unknown time. The orders reflected that Fentanyl 75 mcg patch was discontinued on January 9, 2018 at 1:55 AM.

The patient was transferred to the medical/surgical unit on January 9, 2018, at 2:02 AM. The initial medical/surgical RN assessment by EMP5 on January 9, 2018, at 3:00 AM did not identify or document that there was a Fentanyl patch on the patient. The medication reconciliation by EMP5 did not identify the home medication of Fentanyl upon transfer to the medical/surgical unit. The medication administration record reflected there was an order to check patch placement q (every) shift which started on January 9, 2018 at 8:00 and was discontinued at the time of discharge from the facility.

Review of the medication administration report revealed a new order for Fentanyl 75 mcg patch to start on January 10, 2018, at 9:00 AM. The Medication Administration Report reflected the first check of the patch placement was on January 9, 2018, at 8:00 AM by EMP6 on the left back. There was no practitioner order to remove the previous patch with the new order of Fentanyl starting January 10, 2018, at 9:00 AM. The Medication Administration Record revealed a Fentanyl 75 mcg patch was applied to the right back by EMP7 with a co-signature by EMP8 on January 10, 2018, at 8:40 AM. There was no documentation the old patch was removed by EMP7 or EMP8.

Nursing documentation by EMP4 on January 11, 2018, at 9:08 AM revealed the patient was lethargic and difficult to arouse. The Fentanyl patch was removed from the left back per protocol.

The Medication Administration Report reflected the order to discontinue the Fentanyl 75 mcg patch on January 11, 2018, at 9:08 AM. The orders were changed to Fentanyl 25 mcg patch to start on January 11, 2018, at 09:08 and discontinued at time of discharge.

Nursing documentation by EMP4 on January 11, 2018, at 10:20 AM revealed the patient was alert and slightly less lethargic than the initial assessment. The patient was noted to have an additional 75 mcg fentanyl patch intact to the right back. This was removed when the Fentanyl 25 mcg was applied to the left back. The physician was made aware.

There was a progress note on January 11, 2018, at 11:55 AM from the physician noting the patient was evaluated at the bedside this AM. The patient was pleasantly confused. The patient had no complaints. The patient was not alert to time, place or person. The patient had two Fentanyl patches of 75 micrograms which probably explained the altered mental status, and with one Fentanyl patch the patient's mental status was better. The patient was awake, alert, and able to answer questions a lot more appropriately than earlier.

MR1's discharge summary documented that on hospital day two, the patient was still pleasantly confused, but it was found that patient had two 75 mcg fentanyl patches on, which could explain the patient's mental status. After the removal of the second patch, the patient became more alert and awake. The patient was discharged in stable condition on January 13, 2018.

Review on February 26, 2018 at 11:10 AM of facility's documentation after the event was identified revealed the patient had two 75 mcg Fentanyl patches on. One dated January 10, 2018, and the other patch was clear and not dated. This patch was not put on the patient at this facility.

Review on February 26 and 27, 2018, of the facility's medical/surgical unit staff meeting minutes and education did not reveal changes in the process for transdermal patches, monitoring for home transdermal patch, and removing previous patch prior to placement of a new transdermal patch.

Interview with EMP3 on February 27, 2018 at 10:50 AM confirmed the medical/surgical nursing staff had access to the ED record and should be using the ED record during the medication reconciliation process when transferred to the medical/surgical unit. EMP3 confirmed there was no documentation on the presence of a Fentanyl patch on the initial nursing assessment in the medical/surgical unit or documentation of the Fentanyl patch on the initial medication reconciliation on the medical/surgical unit.

Interview with EMP1 on February 27, 2018 at 11:05 AM confirmed there were no process changes related to transdermal patches after this event.

Interview with EMP3 on February 27, 2108 at 11:08 AM confirmed there was no staff-wide education to nursing related to transdermal patches after this event.

Based on review of facility documents, medical record review and staff interview, it was determined the facility failed to ensure the safety of the electronic order set utilized for topical patches for one of 11 medical records reviewed (MR1).

Findings include:

Review on February 26, 2018, of the facility policy "Specific Procedures for Administering Medications," last reviewed September 8, 2017, revealed "Purpose: The Specific Procedures for Administering Medications policy establishes guidelines for administration of medications. ... Miscellaneous ... 4. Administration of Topical Patches- see package insert for specific instructions. ..."

Review of the Fentanyl package insert instructions provided by the facility on February 27, 2018, revealed a two-page document which stated "Duragesic (Fentanyl Transdermal System) for transdermal administration ... Dosage and Administration ... Each transdermal system is intended to be worn for 72 hours.

Review of the full prescribing information revealed the following additional information: "2.6 Administration of Duragesic Duragesic patches are for transdermal use only. ... Each Duragesic patch may be worn continuously for 72 hours. The next patch is applied to a different skin site after removal of the previous transdermal system. ..."

Review on February 27, 2018 of the facility's Pharmacy meeting minutes dated July 13, 2017, revealed a clinical update regarding checking patch placement and patch removal orders. The pharmacist reviewed the the facility's electronic medical record system change for patch removal functionality and patch placement orders. It was noted that when nursing documented the patch was applied on the Medication Administration Record, a patch removal was now automatically generated. The pharmacy would still need to place a check patch placement order for all patches with a duration of greater than 24 hours.

Review of MR1 on February 26, 2018, at 10:30 AM revealed the patient arrived at the hospital through the Emergency Department (ED) on January 8, 2018, at 10:51 PM with a chief complaint of increased confusion. The emergency medicine note indicated the last dose of Fentanyl 75 mcg patch was January 7, 2018, at an unknown time. The patient was transferred to the medical/surgical unit on January 9, 2018, at 2:02 AM. Nursing documentation by EMP4 on January 11, 2018, at 9:08 AM revealed the patient was lethargic and difficult to arouse.

There was a progress note on January 11, 2018, at 11:55 AM from the physician noting the patient was evaluated at the bedside this AM. The patient was not alert to time, place or person. The patient had two Fentanyl patches of 75 micrograms which probably explained the altered mental status, and with one Fentanyl patch the patient's mental status was better. The patient was awake, alert, and able to answer questions a lot more appropriately than earlier.

MR1's discharge summary documented that on hospital day two, the patient was still pleasantly confused, but it was found that patient had two 75 mcg fentanyl patches on, which could explain the patient's mental status. After the removal of the second patch, the patient became more alert and awake. The patient was discharged in stable condition on January 13, 2018.

Interview with EMP3 on February 26, 2018 at 10:50 AM confirmed that there was no order for a patch removal with the first application of a transdermal patch.

Review on February 26, 2018 at 11:10 AM of facility's documentation after the event was identified revealed the patient had two 75 mcg fentanyl patches on. One dated January 10, 2018. The other patch was clear, not dated, and was not put on the patient at this facility.

Interview with EMP1 on February 27, 2018 at 11:05 AM confirmed that there was no process changes related to transdermal patches after this event.

Cross reference:
482.23(b)(3) RN Supervision of Nursing Care