**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, interview, and record review, the facility failed to ensure: 1. One of three sampled residents (Resident 1) receive a medication accurately and in a safe manner in accordance with the manufacturer's specifications and professional standards of practice to meet the needs of the resident. Upon the resident's re-admission to the facility from the hospital, the facility staff received information Resident 1 was applied a fentanyl transdermal patch (a potent narcotic/opioid applied to the skin, to treat moderate to severe pain) 25 micrograms per hour (mcg/hr)but the facility failed to ensure the hospital-dispensed patch was removed before a new fentanyl 25 mcg/hr patch one was applied. The failure resulted in Resident 1 being transferred to the Emergency Department (ED) with symptoms of somnolence (abnormally drowsy), hypotension (low blood pressure), and oversedation; and identified with two fentanyl patches on her body. She was administered two doses of Narcan (a life-saving medication to reverse an overdose from opioids) 0.04 milligrams (mg, unit of measurement) to relieve symptoms of opioid overdose, and was transferred to hospice care three days after being hospitalized . 2. A controlled medication (those with high potential for abuse and addiction) was accurately reconciled for one of four residents (Resident 2). This failure had the potential for abuse or diversion of controlled medications. Findings: 1. A review of the United States Drug Enforcement Administration (DEA) Drug Fact Sheet, dated 10/2022, Fentanyl is a potent synthetic opioid drug approved by the Food and Drug Administration [FDA] for use as an analgesic (pain relief) and anesthetic [substance inducing insensitivity to pain]. It is approximately 100 times more potent than morphine and 50 times more potent than heroin as an analgesic. A review of the Prescribing Information (PI; detailed description of a drug's uses, dosage range, side effects, drug-drug interactions, and contraindications that is available to clinicians) for fentanyl transdermal patch (brand name: Duragesic), revised 3/2021, indicated it is a potent narcotic applied to the skin, to treat moderate to severe pain. It is designed to release the drug in a slow, steady manner over 72 hours. It can be applied to intact, non-irritated skin on a flat surface such as the chest, back, flank, or upper arm; and that each 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. The PI indicated, A considerable amount of active fentanyl remains in DURAGESIC even after use as directed. Death and other serious medical problems have occurred when children and adults were accidentally exposed to DURAGESIC. The PI indicated acute overdose with fentanyl patch can be manifested by symptoms including breathing problems, somnolence, slow heart rhythms, hypotension, sedation, and death. A review of the FDA Drug Safety Communication, posted 4/13/2023, regarding Fentanyl Transdermal Patch, it indicated, Fentanyl patches that have been worn for 3 days still contain enough medication to cause serious harm or death to adults or children who are not being treated with the medication and Be sure to remove your used patch before applying a new patch. On 6/20/23, a review of Resident 1's clinical record indicated she was an elderly resident admitted to the facility with diagnoses including end-stage renal disease (ESRD; the final, permanent stage of chronic kidney disease, where kidney function has declined to the point that the kidneys can no longer function on their own) with kidney dialysis (procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly), hyperlipidemia (high lipids in the blood), diabetes (disease that impairs the body's ability to regulate blood sugar), upper gastrointestinal bleeding, congestive heart failure (condition in which the heart does not pump blood as well as it should), ischemic cardiomyopathy (heart muscle that can not pump well because of damage from a lack of blood supply to the muscle), recent right above knee amputation (AKA), and AKA wound. A review of Resident 1 ' s physician ' s orders indicated she had been receiving fentanyl 25 micrograms/hour (mcg/hr; the patch delivers 25 mcg of fentanyl per hour continuously) 1 patch on the skin every 72 hours since 12/6/22. A review of Resident 1 ' s clinical record showed Resident 1 was transferred to Hospital A on 5/17/23 due to abnormal lab results. On 6/6/23, she was re-admitted to the facility. A review of Hospital A's Interagency Discharge Summary and Orders, date of service 6/6/23, indicated a list of medications to be continued after hospitalization. The list included: Fentanyl 25 mcg/hr patch, apply 1 patch to skin every 72 hours. This order had a hand-written note indicating patch applied on 6/6/23. A review of Hospital A's medication administration record (MAR) during the 5/17/23 admission for Resident 1 indicated she had been receiving fentanyl (Duragesic) 25 mcg/hr 1 patch every 3 days (or 72 hours) since 5/26/23. The MAR showed a new patch was applied on 6/6/23 at 10 a.m. after the used patch was removed on the same day at 10 a.m. A review of the facility's admission Notes, written by the admitting nurse, Licensed Vocational Nurse (LVN) A, on 6/6/23 at 7:08 p.m., indicated, admitted . female from [Hospital A] . Writer received report from [name of nurse from Hospital A] . Patient is incontinent for both B/B [bowel and bladder]. Last BM [bowel movement] on 6/6/23 . Per nurse, fentanyl patch was placed on L [left] shoulder and to be removed after 72 hours with a new patch after. Further review of Resident 1's physician ' s orders indicated, on day of re-admission of 6/6/23, Resident 1's physician placed an order for fentanyl 25 mcg/hr, apply 1 patch transdermally every 72 for pain mgt [management] and remove per schedule on 6/6/23, to be started on 6/9/23 (or 3 days later). A review of Resident 1's June 2023 MAR indicated LVN B applied a new fentanyl patch, based on the order above, on 6/9/23 at 8:59 a.m.; the documented application site was left chest. During an interview with the Director of Nursing (DON) on 6/20/23 at 11:20 a.m., she stated, for medications that come in patch, the nursing staff has to remove the used patch before applying a new patch. Specifically for fentanyl patch, because it is a potent narcotic medication, she stated the staff would remove it from the resident, fold it in half, place the used patch in a small plastic bag, log it in the Controlled Drug Record (CDR; aka the Count Sheet, an inventory record) that it is removed, and place the plastic bag in the locked narcotic box until it is picked up by her for destruction. She stated they need to do so because the used patch still contains active medication after 3 days use, which has potential for abuse. During another interview on 6/20/23 at 1:30 p.m., the DON stated, even though Resident 1 came back to the facility wearing the hospital-dispensed patch, the nursing staff would still need to remove the used patch, document the removal in the CDR, and keep in the locked narcotic box before applying a new patch. The CDR for Resident 1's fentanyl patch was requested for review. During an interview with LVN B on 6/20/23 at 1:46 p.m., he stated he worked the morning shift on 6/7, 6/8, and 6/9/23; and Resident 1 was under his care during those days. He stated he recalled the resident had a lot of pain issues and had been on a fentanyl patch even before she went to the hospital. He stated he assessed the resident on 6/7/23 (one day after the resident returned from the hospital) and did not see any fentanyl patch on her body. On the day of a new application, on 6/9/23, he stated he assessed the resident again and there was none. He stated, I did not remove the used patch. I assume they didn't put it on. When asked whether he documented he assessed the resident for the patch, he said he would not normally document such assessment. During a concurrent interview and record review on 6/20/23 at 2:17 p.m., the DON provided Resident 1's CDR for fentanyl 25 mcg/hr patch. Under Applied column, the CDR indicated LVN B removed 1 patch on 6/9/23 at 8 a.m. There was no corresponding removal of the used patch on 6/9/23 under the Removed column. The DON verified there was no documented evidence the hospital-dispensed patch was removed. During an interview with Certified Nursing Assistant (CNA) C on 6/20/23 at 2:25 p.m., she stated she cared for Resident 1 on 6/7 and 6/8/23 during the morning shift. She stated Resident 1 needed total assistance from staff for all activities of daily living such as bathing and personal hygiene. She stated Resident 1 had large BMs, requiring a full-body bed bath every day on those days. When asked if she recalled seeing a medication patch on the resident during care, CNA C pointed to her left shoulder and stated she recalled seeing a small patch on left side. She explained she did not recall the exact location but it was on the left chest or arm, during those two days. During an interview with the wound nurse, LVN D, on 6/20/23 at 2:33 p.m., LVN D stated her role as a wound nurse was to assess the resident's skin from head to toe, but focusing more on the wounds. She stated she assessed Resident 1 shortly after she was re-admitted to the facility on [DATE]. When asked whether she recalled seeing a fentanyl patch on her body, LVN D replied, I really don't recall if she had or not. I don't mark it on the assessment form, just the skin and wound thing. During an interview with LVN A on 6/20/23 at 2:40 p.m., she stated she was the admitting nurse the day Resident 1 was re-admitted on [DATE]. She stated she did the admitting procedures for Resident 1 and recalled the conversation with the nurse from Hospital A regarding fentanyl patch being placed on the resident's left shoulder on 6/6/23, that it was to be removed and replaced with a new one 3 days later. LVN A stated she also did the physical head-to-toe assessment on the resident on 6/6/23. When asked if she recalled seeing the fentanyl patch on the resident, LVN A responded, I can't recall but I believe it was on her left side. An interview was conducted with the evening shift nurse, LVN E, on 6/20/23 at 4:02 p.m. LVN E stated she worked the evening shift (from 3:30 - 11:30 p.m.) from 6/6 to 6/9/23. She stated she received Resident 1 the evening she came back on 6/6/23, and Resident 1 was under her care the next three days. She stated she did not get endorsement from LVN A or anyone that Resident 1 was on the fentanyl patch from the hospital, and she did not see a patch on the resident until 6/9/23, after LVN B had applied a new one in the morning. An interview with the evening shift CNA, CNA F, was conducted on 6/20/23 at 4:26 p.m. She stated she cared for Resident 1 the day she returned, the next day, and on 6/9/23. She stated she remembered the resident had a huge BM and had to be changed. She stated the resident had multiple skin tears and a dialysis shunt (an access point to allow direct access to the bloodstream for dialysis), so she needed to be careful during the resident's care. She said she did not recall seeing a patch on the resident as she only bathed her from the waist down. She also stated she was not made aware the resident was wearing a patch from the hospital. Another interview was conducted with the DON on 6/20/23 at 4:36 p.m. When asked what should have taken place when a resident came in on a fentanyl patch, she stated the first thing is to acknowledge that there was an actual patch. She continued, They [the nurses] should have looked for it, then endorsed it to the charge nurse, and created a POC [point-of-care] task for the CNAs to look for it during care. Sometimes from transfer, those patches may have fallen off. She stated the admitting nurse was to endorse it the charge nurse, then charge nurse to the next shift nurse, and so on. She said, Fentanyl is a heavy med and needs to be handled with caution. During another interview with LVN A on 6/20/23 at 5:01 p.m., she stated, It's been a while and I had so many admissions on that day so she did not recall if she verified the resident was actually wearing a patch. She stated she did endorse to the evening nurse, LVN E; and asked her to refer to her admission progress notes. She stated, They can always refer to the admission notes for information, and they are to endorse it to the next shift. During an interview with the DON on 6/20/23 at 5:15 p.m., she explained the nurse-to-nurse endorsement is a verbal, shift-change report where the outgoing nurse explaining residents' needs that the incoming nurse needs to be aware of when taking over the next shift. She stated she could not find any policy and procedures related to staff endorsement or nursing reporting. A review of Resident 1's clinical record indicated a nursing progress notes, written on 6/10/23 at 9:42 p.m., indicating Pt [patient] was not feeling well and was slumped over in her wheelchair since the CNA placed her in her chair to be ready for dialysis. Dialysis did not want to transport the pt if she was not feeling well. pt was feeling 10/10 [10 out of 10 pain score, meaning worst pain] R [right] knee (phantom) pain Called son . and son spoke to pt and they decided for pt to go to [Hospital A] ED. A review of Hospital A's ED Provider Notes, dated 6/10/23, indicated Resident 1 arrived in the ED on 6/10/23 at 11:04 a.m. Under Chief Complaint, the ED record indicated: BIBA [brought in by ambulance] from SNF [skilled nursing facility], c/o [complaint of] R knee pain, s/p [status post] R BKA on 6/6/23 . Arrives lethargic, hypotensive en route. Reportedly missed dialysis today. Under HPI [History of Present Illness], it indicated, [Resident 1] . presenting from SNF for hypotension, AMS [altered mental status], and knee pain. Under Medical Decision Making, a review of the above ED Provider Notes indicated, Patient presenting with acute illness with systemic symptoms, namely hypotension secondary to sedation versus sepsis [a serious medical condition caused by an overwhelming immune response to infection] . patient required admission to the hospital Patient presenting with increased somnolence, hypotension, found to have 2 fentanyl patches on, removed and given Narcan with significant improvement in mental status and blood pressure . also consider possible sepsis. Empirically started on antibiotics [course of treatment for suspected infection before lab results] given hypotension . Given patient's life-threatening hypotension, discussed goals of care with patient and son, confirmed DNR [do not resuscitate] . thus we will admit to medicine. A review of the ED's clinical record indicated Resident 1 received a dose of Narcan 0.04 milligram (mg, unit of measurement) on 6/10/23 at 11:55 a.m.; and another dose on 6/10/23 at 2:58 p.m. while in the ED. A review of the Inpatient Medicine: admission History and Physical [H&P] with date of service 6/10/23 at 4:10 p.m., indicated the Chief Complaint was Hypotension/oversedation. Under History of Present Illness, a review of the above hospital H&P indicated the following: .female . who presented with foot pain and leukocytosis [an increase in the number of white cells in the blood, especially during an infection] found to have worsening osteomyelitis [inflammation or swelling that occurs in the bone] . who presented from SNF somnolent and hypotensive, c/f [concerning for] oversedation . Recently was admitted 5/17 - 6/6/23 and under went AKA with ortho[pedic] on 5/25/23. Briefly, her son . called her phone multiple times on 6/9 but she did not pick up. [Son's name] called the SNF . who recognized that she was quiet [quite] somnolent. Was due for ESRD [dialysis] today . Upon arrival to the ED she was noted to have two fentanyl patches (one on mid-chest, one on L arm). When speaking with her son, prior to admission, she communicated that she would not want procedures or artificial lengthening of her life. She communicated to him that she was at peace and ready to pass. A review of the Assessment/Plan, in the hospital ' s above-mentioned H&P, indicated in part: At time of admission, patient was found to have two fentanyl patches (prescribed as one patch every 72hr). Family believes she had new fentanyl patch placed 6/9 (day prior to admission). She received Narcan 0.04 mg x2 with increased alertness. She was noted to be hypotensive . Narcan drip was started but pressures did not improve. Discussed potential short-term stay in ICU [Intensive Care Unit] for pressors [medications to treat blood pressure] . After multiple discussions between family and medicine . team, family . opted to pursue comfort care. A review of the Acute Issues, of the H&P, it indicated, Oversedation w/ opiates [meaning opioids] and Hx [history of] R foot ulcer, sacral wound, leukocytosis s/p R AKA. A review of the Mission Hospice Inpatient Referral Note, dated 6/13/23, indicated Resident 1 was accepted to GIP on 6/13/23. A review of the hospital's Discharge Summary, dated 6/15/23, indicated Resident 1 was admitted on [DATE], and discharged on 6/13/23. It indicated, Primary team reached out to GIP [General Inpatient Care, a hospice level of care] 6/13/23 . She is planned to be discharged from primary service then readmitted under GIP, Hospice. A review of the Hospital Course and Discharge Plan, By Issue, of the Discharge Summary, it indicated the medical issues of: Comfort Care, hypotensive like mixed 2/2 [secondary to] opioid overdose and comorbidities [presence of two or more diseases or medical conditions] of ESRD and hx of bacteremia [bacteria in the blood] and Oversedation w/ opiates. During a concurrent interview and record review with the DON on 6/20/23 at 5:07 p.m., the DON reviewed the 6/10/23 H&P (as mentioned above) from Hospital A and verified the fentanyl patch location documented in the SNF (left shoulder on 6/6/23 and left chest on 6/9/23) matched the two locations documented by Hospital A (one on mid-chest, one on left arm) on 6/10/23. A telephone interview was conducted with the facility's consultant pharmacist (CP) on 6/21/23 at 12:46 p.m. The CP stated, given the fentanyl patch is a potent narcotic medication with active medication remaining in the patch after 3-day use, it would be advisable to have an order to remove the used fentanyl patch (one the resident came with) before a new one is applied to make sure there is no confusion. When presented with Resident 1's symptoms of somnolence, sedation, and hypotension, he stated somnolence is consistent with opioid overdose symptoms. He stated the hypotension is more rare with opioid overdose, and could be related to the resident's other medical conditions. During a telephone interview with the facility's Medical Director (MD) on 6/22/23 starting at 4:38 p.m., he stated he was told by the facility staff the resident was in pain and possibly had an infection, that was the reason why he ordered to have her sent to the hospital on 6/10/23. He stated he did not know about the hospital finding two patches on the resident. He stated, prior to the interview with the surveyor, he was told the nurse who applied the patch on 6/9/23 said they did not see any patch before the application. When relayed the investigation revealing CNA C seeing the small patch on the left shoulder area for two days, and the facility's documentation of the patch placement matching the location documented by Hospital A, the MD stated, I think the hospital put the patch on the left shoulder on 6/6, and the facility put the patch on 6/9 on the chest, but they didn't remove the patch on the 6th, on the shoulder one. I think that happened. He continued, Fentanyl is a strong pain medication, it can kill people. You have to remove the prior patch before the new one. He stated, When the patient comes from the hospital, or even during nurse to nurse signing out, they should report the patient use the medication and the location of the patch. It's not something to be missed. He added, You don't know the dose remaining in the patch, that's why you remove the patch. During the interview with the MD above, on 6/22/23 at about 4:50 p.m., he stated he had remote access to Resident 1's clinical record from Hospital A. After a brief review, the MD stated, They said patient was quite somnolent, did not go to dialysis, found two fentanyl patches one on mid chest, one on left arm, communication with family, transfer patient to hospice. He reviewed the resident's presenting symptoms at the ED and stated, For sedation, at least we can say sedation because of too much narcotic. For the hypotension, it's hard because the patient had ESRD and also sepsis, I'm not sure that component is due to the narcotic; how much was due to the narcotic and how much due to her other conditions. He stated, If the resident received Narcan and she improved, then that's part of the somnolence at least. A review of the facility's policy and procedures (P&P) titled Administering Medications, revised April 2019, indicated, Medications are administered in a safe . manner, and as prescribed. A review of the facility's P&P titled Administering Topical Medications, revised October 2010, indicated the following for transdermal patches, Clean and dry a selected area that is approved for application of the patch . Remove old patch. 2. On 6/20/23 at 10:14 a.m., medications in the 2B Medication Cart was observed with the DON. She was asked to reconcile controlled medications for four random residents. At this observation, Resident 2's oxycodone (a potent narcotic medication to treat pain) 5 milligrams (mg, unit of measurement) was observed in a clear 6-ounce cup, inside the locked narcotic compartment. There were 7 tablets inside the cup. A review of Resident 2's controlled drug record (an inventory sheet) for oxycodone 5 mg with the DON indicated: on 6/20/23 at 5:30 a.m., one tablet was removed; the remaining amount was 9 tablets. Four hours later, on 6/20/23 at 9:30 a.m., Licensed Vocational Nurse G (LVN G) removed 1 tablet, but the quantity remaining was 7 tables (instead of 8 tablets). The DON acknowledged the math was incorrect. On 6/20/23 at 10:21 a.m., the DON asked LVN G to explain what happened. LVN G stated she gave 2 tablets in the morning but mistakenly documented she removed 1 tablet, hence the wrong math. A review of Resident 2's physician's order, dated 6/14/23, for oxycodone 5 mg, 1 tablet by mouth every 4 hours as needed for moderate pain, and 2 tablets every 4 hours as needed for severe pain. A review of Resident 2's medication administration record (MAR) with the DON on 6/20/23 at 10:24 a.m. revealed LVN G did not document the administration of 2 tablets of oxycodone to Resident 2 at 9:30 a.m. The DON stated the nurse needed to document right away to avoid another nurse giving the medication too soon because the previous one was not documented on the MAR. A review of the facility's P&P titled Documentation of Medication Administration, dated 11/2022, indicated, A nurse . documents all medications administered to each resident on the resident's medication administration record (MAR). Administration of medication is documented immediately after it is given.