Finding Description
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 2. Resident #11 was admitted to the facility on [DATE] with diagnosis including type 2 diabetes mellitus with diabetic polyneuropathy.
The care area assessment dated [DATE] revealed Resident #11 was diagnosed with diabetic polyneuropathy and bilateral osteoarthritis of knee with chronic pain. She was cognitively intact and had reported experiencing almost constant pain within the 7-day review period.
The quarterly Minimum Data Set (MDS) assessment dated [DATE] coded Resident #11 with intact cognition. She had adequate vision and hearing with clear speech. The MDS indicated Resident #11 received both scheduled and as needed (PRN) pain medications, insulin, antianxiety, antidepressant, and hypoglycemic during the 7-day review period.
The care plan for pain initiated on 03/27/25 revealed Resident #11 had pain related to osteoarthritis. The goals were for her to verbalize adequate pain relief through the review date. Interventions included anticipating Resident #11's need for pain relief and responding immediately to any complaint of pain.
The physician's orders dated 03/17/25 revealed Resident #11 had obtained orders to receive insulin glargine (a long-acting insulin used to control high blood sugar) 8 units subcutaneously once daily for diabetes and 2 tablets of metformin (an oral antidiabetic medication used to treat diabetes) 500 milligrams (mg) by mouth twice daily for diabetes. On 03/19/25, the physician started Lyrica (a fibromyalgia agent used to treat nerve pain) 100 mg, 1 capsule by mouth 3 times daily for pain.
A review of nurse's progress notes dated 05/11/25 at 6:04 AM, 05/12/25 at 8:37 AM, and 05/12/25 at 6:12 PM revealed 3 different nurses working in 3 different shifts documented metformin was unavailable and it was not administered to Resident #11. A further review of nurse's progress notes dated 05/12/25 at 7:33 AM revealed Nurse #7 documented the pharmacy needed prescription of Lyrica for Resident #11. She notified the Nurse Practitioner (NP) regarding the need of a prescription for Lyrica immediately. Then, she checked on Resident #11 who stated she did not have any pain or discomfort at that time. On 05/12/25 at 8:23 PM, Nurse #8 documented insulin glargine was unavailable. He could not find the insulin in the medication cart or refrigerator.
A review of Pyxis records and inventory list revealed 251 different medications were kept in the Pyxis for emergency uses. Further review of the Pyxis Inventory Replenishment Report dated 05/11/25 revealed the facility had 8 tablets of Metformin 500 mg and one 3 milliliters (ml) pen of insulin glargine in the Pyxis.
The Medication Administration Records (MAR) revealed Resident #11 did not receive 3 doses of metformin scheduled on 05/11/25 at 8 AM, 05/12/25 at 8 AM and 6 PM; 3 doses of Lyrica scheduled on 05/11/25 at 8 PM, 05/12/25 at 6 AM and 2 PM; and 1 dose of insulin glargine scheduled on 05/12/25 at 9 PM.
A further review of Resident #11's medical records revealed the refill order for Lyrica was submitted to the pharmacy by Nurse #7 on 05/11/25 at 2:50 AM when there were 2 tablets remaining in the medication cart. The last tablet of Lyrica was administered on 05/11/25 at 2 PM. When Nurse #7 called on 05/12/25 at 7:30 AM to follow up with the Lyrica order, the pharmacy staff stated they needed the prescription as it was a controlled medication. Nurse #7 notified the NP to submit a prescription for Lyrica immediately. When Lyrica arrived at the facility on 05/12/25 at 11 PM, Resident #11 had already missed 3 doses of Lyrica. On the other hand, both metformin 500 mg and insulin glargine were available in Pyxis but not being administered by the nurse.
During an interview conducted on 05/12/25 at 3:31 PM, Resident #11 stated she had not received her Lyrica for 3 days and added she started to feel the pain since 05/10/25. She wanted to know why her Lyrica had not been refilled yet and indicated this was not the first time it had happened.
A further review of MAR indicated Resident #11 had missed 3 doses of Lyrica at the time of interview on 05/12/25 at 3:31 PM, but not 3 days. She received Lyrica 3 times per day until she missed the first dose on 05/11/25 at 8 PM, then 2 more doses on 05/12/25 at 6 AM and 2 PM. Further review of MAR revealed Resident #11 had a scheduled order of hydrocodone/acetaminophen (a semi-synthetic opioid used to treat pain) 5/325 mg that was discontinued on 05/06/25, and a new order of tramadol (an analgesic/opioid used to relieve pain) was initiated on 05/12/25.
During a phone interview conducted on 05/15/25 at 1:23 PM, Nurse #7 stated she was the nurse who submitted the refill order of Lyrica for Resident #11 on 05/11/25 morning when 2 tablets remained in the medication cart. She recalled she could not put in a STAT order as she did not even have a prescription when submitting the refill order through the computer system. When she returned to work on 05/12/25 in the morning and found that Lyrica had still not arrived at the facility, she called the pharmacy to follow up and was told that the pharmacy needed a prescription. She could not recall whether she had told the pharmacy staff to code this Lyrica order as a STAT order during the phone call. She notified the NP that the pharmacy needed a prescription for Resident #11's Lyrica and went to check Resident #11. She recalled Resident #11 did not appear to be in pain or distress. She explained to Resident #11 that the pharmacy needed a prescription, and she had notified the NP about it. She asked Resident #11 if she was suffering any nerve pain Resident #11 replied that she was okay.
During a subsequent observation and interview conducted on 05/12/25 at 4:12 PM, Resident #11 appeared to be calm, pleasant, and free of signs and symptoms of pain or distress. She stated her nerve pain was okay and manageable, but she was upset about not getting her Lyrica as ordered.
An interview was conducted with Nurse #8 on 05/13/25 at 4:44 PM. He stated Resident #11's Lyrica was delivered from the pharmacy on 05/12/25, arrived at the facility around 11:00 PM, and was administered right after receiving it. He stated he could not find metformin and insulin glargine in the medication cart or refrigerator on 05/12/25 in the evening and added he did not check for both medications in Pyxis. Nurse #8 acknowledged that he did not check with the pharmacy on 05/12/25 in the evening to ensure both medications had been re-ordered.
During an interview conducted on 05/13/25 at 4:53 PM, the Interim Director of Nursing stated the facility had Pyxis that provided emergency medications including several narcotics and controlled substances as needed. Not only did the facility have metformin and insulin glargine in the Pyxis, but the facility also had a back-up pharmacy approximately 0.25 miles from the facility. She did not receive any notification regarding availability of metformin and insulin glargine on 05/12/25. Otherwise, she could have gotten both medications from Pyxis. She stated Pyxis had 8 tablets of metformin 500 mg and one insulin glargine pen on regular basis and this resources should be fully utilized. She stated the pharmacy would not dispense any controlled medication such as Lyrica without a prescription issued by the physician. It was her expectation for nurses to start refilling procedures at least 5 days before the last pill was used to avoid a gap, especially controlled medication that required a prescription.
A phone interview was conducted with the Pharmacy Manager on 05/15/25 at 12:20 PM. He stated the pharmacy computer system received the refill order of Lyrica for Resident #11 on 05/11/25 at 2:50 AM. As the order was not coded as a STAT (signified the order needed to be done immediately, with the highest priority) order and the pharmacy did not receive a refill prescription from the physician, the pharmacy could not process and fill the medication until the next day after the prescription for Lyrica was received on 05/12/25 at 9:07 AM. Lyrica was filled and then placed in the pharmacy totes at 3:17 PM and delivered to the facility as a regular order. He stated the delivery typically arrived at the facility before mid-night. The Pharmacy Manager stated if the facility staff specified it was a STAT order, they would try to deliver it to the facility within the specified time frame. Otherwise, the pharmacy had designated a back-up pharmacy locally near the facility. He confirmed the facility had Pyxis for medication needed after hours or emergency, and it consisted of insulin glargine and metformin 500 mg, but not Lyrica 100 mg. He indicated tramadol could alleviate nerve pain, but not to a great extent. He stated if the refilled order for Lyrica was submitted with a prescription and specified as a STAT order, the pharmacy could have filled and delivered the ordered Lyrica to the facility on [DATE] before midnight. He stated nurses should retrieve both metformin 500 mg and insulin glargine in Pyxis instead of charting it as missed doses.
A phone interview was conducted on 05/16/25 at 9:57 AM with the MD. He stated Resident #11 had a personality disorder and drug seeking behavior. Almost each time he visited her, she would ask for more pain medications, including Lyrica. He stated Resident #11 had been taking Lyrica since 03/19/25 and it typically took approximately 35 hours to be fully eliminated from the body. As Resident #11 was out of Lyrica for approximately 24 hours, clinically, she should still have certain level of Lyrica in her system to prevent her from triggering nerve pain. In addition, Resident #11 received Depakote 500 mg daily for bipolar disorder which had also been used as off-label to treat neuropathic pain. Resident #11 used to have an order of Norco 5/325 mg for 14 days and it was just discontinued on 05/06/25, about a week before Lyrica was run out. Besides, Resident #11 was taking other medications such as trazodone, clonazepam, and methocarbamol which could alleviate her pain level. He stated there were many factors that could affect her pain level and Resident #11 could have confused about muscular pain versus nerve pain. He would not rule out the possibility of Resident #11 experiencing nerve pain 24 hours without Lyrica, but the chances were very low. It was his expectation for the nursing staff to start the refilling process at least a few days before the supply ran out, especially for those controlled substances that required a prescription. He also expected nursing staff to pay attention to the content of Pyxis and fully utilize it as needed as indicated.
During a phone interview conducted on 05/16/25 at 10:46 AM, the Administrator expected nursing staff to submit refill order at least 3-5 days before the medication ran out and ensure refill order for controlled medication was submitted with the prescription. It was her expectation for all nursing staff to be proficient in the content of Pyxis and fully utilized it as needed as indicated.
Based on observations, record review, and Nurse Practitioner (NP), Medical Director (MD), resident and staff interviews, the facility failed to prevent a significant medication error when Nurse #1 administered a steroid medication to Resident #283 that were prescribed for Resident #86. In addition, the facility failed to request a prescription from the physician to avoid a gap in medication administration when refilling a controlled medication and failed to utilize medication resources stored in the Pyxis (an automated dispensing machine that provided secure medication storage on patient care units, along with electronic tracking of the use of narcotics and other controlled medications) which resulted in the Resident #11 missing 3 doses of nerve pain medication, 3 doses of diabetic medication, and 1 dose of insulin. This deficient practice occurred for 2 of 2 residents reviewed for significant medication error (Resident #283 and Resident #11).
The findings included:
1. Resident #283 was admitted to the facility on [DATE] with diagnosis that included parkinsonism, type 2 diabetes mellitus, chronic kidney disease stage 3, myocardial infarction type 2 (a heart attack that occurs due to an imbalance between the hearts oxygen supply and demand), hypertension (high blood pressure), and edema (swelling).
Review of the 5-day Prospective Payment System (PPS) assessment dated [DATE] revealed that Resident #283 was cognitively intact. He received antidepressant, anticoagulant, antibiotic, diuretic, antiplatelet, and hypoglycemic medications.
Review of the change in condition communication form written by Nurse #1 and dated 4/28/25 at 8:50 AM revealed Resident #283 was administered the wrong medications as follows: Lexapro (antidepressant) 10 milligrams (MG), Lasix (diuretic) 40 MG, Jardiance (a medication used to treat type 2 diabetes) 10 MG, Lisinopril (a medication used to treat high blood pressure) 40 MG, Metoprolol extended release (ER, a medication used to treat high blood pressure) 12.5 MG, and Prednisone (steroid medication used to treat many diseases and conditions that are associated with inflammation) 40MG. Resident #283 was informed of the medication that was given in error and the plan to notify the provider now. Things that made the condition or symptom worse were unknown. Things that made the condition or symptoms better were noted as keeping Resident #283 and the family informed and monitoring Resident #283's vital signs every 15 minutes for 2 hours, then every 30 minutes for one hour, then every 4 hours. Other relevant information noted Resident #283 was provided with a list of medications given in error. Each medication was explained, including the indications for use and possible side effects. Resident #283's vital signs remained normal. Mental status changes included Resident #283 became anxious when informed of the medication errors, all questions were answered, and he was seen by the Nurse Practitioner (NP) within 30 minutes. The NP assured Resident #283 he would be ok, and he seemed less anxious after the NP visit. Resident #283 had no functional status, respiratory, abdomen, or urine changes noted. The NP determined that Resident #283 did not need to be sent to the hospital, but staff would continue to monitor him at the facility.
An interview on 5/15/25 at12:03 PM with Nurse #1 revealed that she was Resident #283's assigned nurse on 4/28/25 during the hours of 7:00 AM to 3:00 PM. Nurse #1 stated that she entered Resident #283's room and called him by Resident #86's name but she did not think he had heard her because he had his continuous positive airway pressure (CPAP, a machine that is used to treat sleep apnea and other breathing disorders) machine on. She stated that his nasal canula needed to be put on and there was no oxygen tubing in the room, so she left the room to go get Resident #283 oxygen tubing. Nurse #1 stated it was at this point she felt very overwhelmed and when she returned to the medication cart, she pulled out Resident #86's medications to administer to Resident #283. Nurse #1 stated she then reentered Resident #283's room and administered the medications. After Resident #283 took the medications, she called him by Resident #86's name and Resident #283 replied that was not his name. Nurse #1 stated she realized she had administered the wrong medications to Resident #283 and immediately took his vital signs, called the physician, and notified the Director of Nursing (DON). Nurse #1 further stated she also printed off a list of the medications that she had given Resident #283 in error and notified him that she would be monitoring him every 15 minutes. Nurse #1 recalled Resident #283 stating that he was scared but he refused the offer to go to the hospital. Nurse #1 further revealed that Resident #283 never displayed any side effects from having received the wrong medications.
Review of the April 2025 MAR for Resident #86 revealed the following significant medication prescribed for Resident #86 was administered to Resident #283 in error on 04/28/25:
- Prednisone (steroid) 20 mg - two tablets by mouth one time a day for pneumonia, chronic obstructive pulmonary disease (COPD, lung disease that makes it difficult to breathe) for 5 days.
Review of the April 2025 medication administration record (MAR) for Resident #283 revealed physician orders for the following routine medications to be administered at 8:00 AM daily:
- Aspirin (antiplatelet) 81 MG - one tablet by mouth one time a day for supplement
- Bumetanide (diuretic) 1 MG - one tablet by mouth one time a day for chronic kidney disease.
- Citalopram (antidepressant) 20 MG - one tablet by mouth one time a day for depression.
- Glucotrol extended release (oral hypoglycemic) 5 MG - one tablet by mouth one time a day for diabetes.
- Valsartan (antihypertensive) 320 MG - give 0.5 tablet by mouth one time a day for hypertension.
- Famotidine (treats gastroesophageal reflux) 20 MG - one tablet by mouth one time a day for gastroesophageal reflux disease (GERD, chronic condition where stomach acid flows back into the esophagus causing heartburn).
- Enoxaparin injection (anticoagulant) 40 MG/0.4 milliliter (ml) - inject 0.4 ml (40 mg) under the skin in the morning and at bedtime.
- Sodium Bicarbonate (treats heartburn) 650 MG - one tablet by mouth two times a day for supplement.
- Multivitamin with minerals - one capsule by mouth two times a day for supplement.
- Carbidopa-Levodopa (medication used to treat Parkinson's disease) oral tablet 25-250 mg - one tablet by mouth four times a day for Parkinson's.
Further review of Resident #283's April 2025 MAR revealed all 8:00 AM medications were held on 04/28/25 except for the Carbidopa-Levodopa 25-250 mg.
Review of the vitals monitoring form for Resident #283 initiated on 04/28/25 at 9:00 AM revealed his vitals (temperature, pulse, respiratory rate, blood pressure, and oxygen saturation) were checked every 15 minutes for the first 2 hours, then every 30 minutes for one hour, then every 4 hours for 24 hours, and then every shift for 48 hours with no issues noted.
Review of a nurse progress note written by the former DON dated 4/28/25 revealed that Resident #283 was seen by the NP after a reported medication error. There were no adverse effects noted for Resident #283. Resident #283 and his family chose not to be transferred to the hospital. Monitoring was put in place immediately and vital signs were stable.
Review of a NP progress note dated 4/28/25 revealed in part, that Resident #283 was found sitting up in his bed, tearful. Nursing staff told the NP that Resident #283 had received medications that were not prescribed to him. The NP assessed Resident #283 and found his vital signs were within normal limits and instructed nursing staff to continue ongoing assessment of Resident #283's vital signs. Resident #283's heart, lung and bowel sounds were all normal and there was slight trace edema on the lower extremities (legs). Resident #283 had oxygen via nasal cannula present on admission and was alert and oriented. Resident #283's medications were reviewed.
An interview on 5/16/25 at 12:33 PM with the former DON revealed that she recalled Resident #283. The former DON stated that when Nurse #1 made a medications error on 4/28/25, Nurse #1 informed Resident #283, the NP and the DON. She stated that she and Nurse #1 assessed Resident #283 after the medication error and put in place continued monitoring every 15 minutes. The former DON further revealed that Resident #283's vital signs remained stable after the incident. The former DON indicated that she reviewed the 5 rights of medication administration education with all nurses and medication aides (MA). She stated that there were no adverse effects noted for Resident #283. The former DON stated that Nurse #1 should have identified Resident #283 prior to pulling the medications and then again before administering the medications by asking Resident #283 to state his name, since Resident #283 was alert and oriented and a new resident. She stated that the facility offered to take Resident #283 to the hospital, but he declined.
An interview on 5/15/25 at 11:20 AM with the NP revealed that Nurse #1, who administered the wrong medications, called her when she was on her way to the facility. The NP stated that she told Nurse #1 to lock her cart, tell the DON, and assess Resident #283. The NP stated that when she arrived at the facility, she assessed Resident #283 and reviewed the medications that were given in error. The NP stated that she offered to send Resident #283 to the hospital, but he refused. She further revealed that she informed Nurse #1 to hold his regular medications for the remainder of the day. The NP stated that the medications Resident #283 received in error were similar to the medications that he was prescribed. She further stated that he suffered no ill effects to his health or well-being because of the medication error. The NP stated that after she was done assessing Resident #283, she went to speak with the DON about the medication error. She revealed that she checked on Resident #283 the following day and he remained stable and continued to refuse transfer to the hospital.
An interview on 5/16/25 at 3:36 PM with the Medical Director revealed that he was familiar with Resident #283 and was aware of the medication error. The Medical Director stated that the doses of the medication Resident #283 received in error were low and the medications were similar to what Resident #283 was prescribed. He stated that they had no negative effect on Resident #283 and they did not harm him.
An interview on 5/16/25 at 5:21 PM with the Administrator revealed that Nurse #1 gave the wrong medication to Resident #283 and she was very up front about it and notified Resident #283, the NP, and the family. She stated that she was not sure why the medication error occurred. The Administrator stated that there were 2 new admissions that day and maybe Nurse #1 got confused. She stated that Nurse #1 should have asked Resident #283's name before she pulled the medications and then asked him again before she gave the medications to him. The Administrator stated that Resident #283 was monitored for 48 hours after the medication error occurred and he had no adverse effects because of the error. She stated that her expectation was that the 7 rights of medication administration were completed which included verifying the right resident got the right medications before medication was administered.