BARDSTOWN, KY- SIGNATURE HEALTHCARE AT COLONIAL REHAB & WELLNESS

Ensure that residents are free from significant medication errors.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 49267

Based on interview, record review, and facility policy review, it was determined the facility failed to ensure residents were free of any significant medication errors for one of seven sampled residents (Residents (R)58).

On 05/03/2022, R58 developed increased altered mental status and was sent to the emergency room (ER) for evaluation. During assessment of R58 at the ER, the ER nurse discovered a 75 microgram (mcg) fentanyl patch (narcotic medication used to treat severe pain) on the resident’s left upper arm/shoulder. However, review of the facility’s information for R58 revealed no documentation noting fentanyl as one of R58’s medications. Review of R2’s (R58’s roommate) orders revealed that resident had an active order for a 75 mcg fentanyl patch. The Director of Nursing (DON) assessed R2 and did not find the resident’s prescribed fentanyl patch.

The facility’s failure to have an effective system to ensure residents were free from significant medication (med) errors is likely to cause serious injury, impairment, or death.

Immediate Jeopardy (IJ) and Substandard Quality of Care (SQC) were identified on 07/03/2024 and determined to exist on 05/03/2022 at 42 CFR 483.45, Residents are Free of Significant Med Errors, (F760) at the highest Scope and Severity (S/S) of a J. The facility was notified of the IJ on 07/03/2024.

An acceptable Immediate Jeopardy Removal Plan was received on 07/08/2024, which alleged removal of the IJ on 07/09/2024 and the State Survey Agency (SSA) validated IJ was removed on 07/09/2024, prior to exit on 07/11/2024. Non-compliance remained in the area of 42 CFR 483.45, Residents are Free of Significant Med Errors (F760) at a Scope and Severity (S/S) of a D while the facility monitors the effectiveness of systemic changes and quality assurances activities.

The findings include:
Review of the facility’s policy titled, Medication Administration, dated 09/2018, revealed two resident identifiers and triple medication verifications were required prior to medication administration. Continued policy review revealed the resident identifier methods to use might include: checking residents’ identification bands; checking residents’ photographs attached to the medical record; or verifying a resident’s identification with other nursing care personnel. Further review revealed medications supplied for one resident should never be administered to another resident.

Review of the facility’s policy titled, Notification of Change of Condition dated 07/07/2022, and last revised 09/15/2023, revealed the facility must inform the resident, consult with the physician, and notify the resident’s representative when there was a significant change in the resident’s physical, mental or psychosocial status, or a decision to transfer or discharge a resident from the facility was made. Further review of the policy revealed the medical provider was to provide guidance related to the resident’s change in condition.

Review of the facility’s policy titled, Controlled Medication dated 11/13/2023, and last reviewed 05/30/2024, revealed the facility was to ensure controlled medications recordkeeping was in place in accordance with federal, state, and other applicable laws and regulations.

Review of the fentanyl patch package insert revealed the following common adverse effects which included: nausea, vomiting, insomnia, dizziness, constipation, hyperhidrosis (excessive sweating), fatigue, feeling cold, anorexia, diarrhea, somnolence (excessive sleepiness), and headache.

1. Review of R58’s closed medical record Face Sheet revealed the facility admitted the resident on
04/21/2022, with diagnoses of pneumonia, parkinson’s disease, and need for assistance with personal care.

Review of R58’s 5-Day Minimum Data Set (MDS), dated [DATE], revealed the facility assessed the resident to have a Brief Interview for Mental Status (BIMS) score of 14 out of 15, indicating intact cognition.

Review of R58’s Physician Order Report dated 04/03/2022 through 05/03/2022 revealed no documented evidence of an order in place for a 75 microgram (mcg) fentanyl patch.

Review of R58’s, Medication Administration Record (MAR) dated 05/01/2022 through 05/03/2022 revealed no documentation noting administration of a fentanyl patch. Further review revealed R58 had an order for Tylenol 325 milligrams (mg), two tablets every four hours as needed for mild pain.

Review of R58’s progress note dated 05/03/2022 at 10:11 AM, revealed the resident felt unwell and
documentation noting a decline in mental status. Continued review revealed documentation noting R58 experienced arousal difficulty and failed to swallow her medications. Per review of the progress note, staff notified the physician and received orders to draw blood for laboratory (lab) values; obtain an x-ray; and an electrocardiogram (EKG). Further review revealed R58’s family decided later to have the resident sent to the hospital for evaluation.

Review of the facility’s Event Report dated 05/03/2022, for this incident involving R58 revealed the resident had been lethargic and drowsy, but oriented to person, place, time, and situation. Continued review revealed R58 received an incorrect medication, and the facility transferred the resident to the hospital.

Review of the facility’s document titled, Investigation undated, revealed the facility determined R58’s roommate had a fentanyl patch ordered which was documented as changed on 05/02/2022 and placed on the resident’s roommate’s left shoulder by an agency Kentucky Medication Aide (KMA). Further review revealed the facility made multiple unsuccessful attempts to contact the KMA. In addition, review revealed the facility determined a medication error had occurred after ER staff called the facility to clarify orders upon discovering the fentanyl patch on R58.

Review of the Emergency Medical Services (EMS) run sheet dated 05/03/2022 for R58 revealed the following information at 9:42 AM-call received for person with altered mental status and lethargy for two days, onset on 05/02/2022 at 8:00 AM. Per review of the EMS run sheet at 9:51 AM, EMS made contact with R58, and the assessment of the resident revealed she was sitting up in wheelchair, confused, only oriented to her name, and was found to have a pulse oximetry (ox) reading of 81% on room air (oxygenation status significant for hypoxia). Review revealed R58 was placed on two liters of oxygen per nasal cannula and the resident’s oxygenation status improved to 97%. Further review of the EMS run sheet revealed at 10:01 AM, EMS left facility with R58 to transfer to hospital and at 10:51 AM, EMS arrived at the hospital with the resident and gave report to the triage nurse.

Review of R58’s hospital records dated 05/03/2022 revealed the resident presented to the emergency room (ER) with confusion, nausea, vomiting, and lethargy. Per review, during the assessment of R58, the ER Registered Nurse (RN) discovered a 75 microgram (mcg) fentanyl patch with no initials, date, or time located on the resident’s left upper chest/shoulder area. Continued review of the hospital records, revealed the ER RN contacted the nursing facility and informed the facility’s Director of Nursing (DON) that R58 had the fentanyl patch in place. Review of the hospital records also revealed the Assistant DON (past not current) called the ER and reported to the ER nurse a medication error occurred regarding the fentanyl patch which had been placed on R58 on 05/02/2022 at 9:00 AM. Further review revealed the ER nurse informed R58’s family of the medication error made at facility. Additional review revealed R58 remained as an inpatient at the hospital for five days and upon discharge the resident was discharged to another facility.

Review of R58’s, Discharge Summary, dated 05/10/2024 revealed a discharge diagnosis of encephalopathy secondary to fentanyl side effect.

2. Review of R2’s medical record Face Sheet revealed the facility admitted the resident on 08/22/2020, with diagnoses of dementia, chronic lymphocytic leukemia, and chronic pain syndrome. Review of R2’s Annual MDS with an ARD of 06/16/2024, revealed the facility assessed the resident to have a BIMS score of one out of 14, indicating severely impaired cognition.

Review of R2’s, Physician Order Report dated 04/03/2022 through 05/03/2022, revealed the resident had an active order for a fentanyl patch 75 mcg to be changed every three days.

Review of R2’s MAR dated 05/02/2022, revealed KMA 1 documented a fentanyl patch was applied to R2’s left shoulder between 6:15 AM and 10:00 AM on that date.

Review of R2’s Controlled Drug Record revealed fentanyl patch 75 mcg documented as applied to the left shoulder of the resident on 05/02/2022, by KMA 1.

The State Survey Agency (SSA) Surveyor attempted interview with R2 on 05/16/2024 at 9:37 AM; however, the resident was not interviewable.

In interview with KMA 1 on 05/15/2024 at 10:48 AM and on 07/03/2024 at 10:53 AM, she stated she was employed by an agency, and worked per diem (by the day) at the facility during 2022. She stated she had been a KMA since 2015. KMA 1 stated she did not recall R58, had never placed a fentanyl patch on a resident and did not recall any incident at the facility of putting a fentanyl patch on the wrong resident. She stated she did not recall ever being asked about a medication error at the facility.

In interview with the Staff Development Coordinator (SDC) on 05/16/2024 at 9:39 AM, she stated she was the nurse working with the agency KMA who passed medications in R58’s room on 05/02/2022. The SDC also indicated she was the 2nd signature when the KMA signed out the fentanyl patch; however, the SDC did not recall observing the KMA place the patch on a resident. The SDC stated later on 05/02/2022 the resident appeared sleepier than usual on that date but answered questions without difficulty. The SDC stated nursing continued to monitor R58 and notified the physician and the following day the resident displayed increased drowsiness and was sent out to the hospital. She further stated the facility’s policy required two patient identifiers to be confirmed prior to administration of medications. Additionally, the SDC stated she was unaware of any education provided to the KMA.

On 05/23/2024 at 12:23 PM, the SSA Surveyor requested contact information for the previous DON; however, the facility was unable to locate or provide that information.
The SSA Surveyor attempted telephonic (phone) interview with R58’s family; however, no return call was received.

In an interview with the Pharmacist on 07/03/2024, he stated there had been no obvious interactions with R58’s medications and the concern with a fentanyl patch was giving someone a sudden dose of that medication at that strength. The Pharmacist stated the symptoms experienced by R58 were consistent with fentanyl side effects in someone who was opioid naive, meaning that person was not prescribed the medication or had only recently used opioid drugs.

During an interview with the DON on 05/23/2024 at 12:48 PM and at 1:34 PM, she stated the medication error involving R58 was reported to the state and an event form was completed. The DON stated notifications were made to both the physician and to R58’s family. She stated identifiers used for medication administration at the facility included: pictures of residents on the MAR; residents’ names on their doors; residents’ name and birthdate; and verification of the resident with other staff. The DON stated if medication errors occurred, staff received education in-services on the rights of medication administration and reporting responsibilities. She further stated the rights of administration helped prevent medication errors and adverse
effects to residents.

Interview with the DON, on 07/03/2024 at 12:13 PM, revealed medication administration now includes a down-time system including a printable medication administrtion record that includes the resident’s room number and a picture of the resident.

During an interview with the Administrator on 05/23/2024 at 1:49 PM, he stated it was his expectation for staff to properly identify residents prior to medication administration. The Administrator stated medication errors were reviewed during the facility’s monthly Quality Assurance Performance Improvement (QAPI) meetings.