Other·March 30, 2023

F755 §483.45 Pharmacy Services The facility must provide routine and emergency drugs and biologicals to its residents, or obtain them under an agreement described in §483.70(g). The facility may permit unlicensed personnel to administer drugs if State law permits, but only under the general supervision of a licensed nurse. §483.45(a) Procedures. A facility must provide pharmaceutical services (including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals) to meet the needs of each resident. §483.45(b) Service Consultation. The facility must employ or obtain the services of a licensed pharmacist who-- §483.45(b)(1) Provides consultation on all aspects of the provision of pharmacy services in the facility; §483.45(b)(2) Establishes a system of records of receipt and disposition of all controlled drugs in sufficient detail to enable an accurate reconciliation; and §483.45(b)(3) Determines that drug records are in order and that an account of all controlled drugs is maintained and periodically reconciled. The facility failed to provide routine medications to meet the needs of residents for two of three sampled residents (Resident 1 and Resident 2) when: 1. Resident 1 did not receive his Keppra (generic name: levetiracetam, a medication to treat seizure disorder [a sudden, uncontrolled electrical disturbance in the brain. It can cause changes in your behavior, movements or feelings, and in levels of consciousness]) for 48 hours due to the medication not being available. The nursing staff did not notify the physician when the medication was not available to give, nor did they follow up with the pharmacy to receive the medication timely. The failure resulted in Resident 1 experiencing multiple episodes of seizures, became unresponsive while being transferred to Emergency Department (ED), and was hospitalized for treatment. 2. Resident 2 did not receive her Keppra due to medication not available x 1 dose. This failure placed Resident 2 at risk to experience seizures, falls, and injuries related to seizures. Findings: According to an online publication titled "Missed Medicines as a Seizure Trigger" by the Epilepsy Foundation, it indicated, "Missing doses of seizure medicine is the most common cause of breakthrough seizures. Missed medicines can trigger seizures in people with both well-controlled and poorly controlled epilepsy. Seizures can happen more often than normal, be more intense or develop into long seizures called status epilepticus. Status epilepticus is a medical emergency and can lead to death if the seizures aren't stopped. Missing doses of medicine can also lead to falls, injuries and other problems from seizures and changes in medicine levels." (https://www.epilepsy.com/what-is-epilepsy/seizure-triggers/missed-medicines; accessed 3/22/23) 1. On 3/17/23, a review of Resident 1's clinical record indicated he was admitted to the facility with diagnoses including multiple sclerosis (a disabling disease of the brain and spinal cord where immune system attacks the protective sheath [myelin] that covers nerve fibers and causes communication problems between your brain and the rest of your body), muscle weakness, abnormality of gait and mobility, and epilepsy (also called seizure disorder). A review of Resident 1's Minimum Data Set (MDS, a care area assessment and screening tool), dated 2/1/23, indicated he had a BIMS score of 12 (Brief Interview for Mental Status, a test given by medical professionals that helps determine a patient's cognitive understanding that can be scored from 1 to 15), which indicated his cognitive condition was moderately impaired. Further review of Resident 1's clinical record indicated a physician's order, dated 7/28/22, for Keppra 500 milligrams (mg, unit of measurement), "Give 1,000 mg by mouth two times daily for seizures." The facility scheduled it to be given daily at 9 a.m. and 5 p.m. Resident 1 was also receiving Dilantin (anti-seizure medication) 100 mg, 2 capsules in the morning and 2 capsules in the evening, starting 1/29/23. A review of Resident 1's March 2023 medication administration record (MAR) indicated Keppra tablets were not administered for 48 hours, on 3/3/23 at 9 a.m. and 5 p.m. and 3/4/23 at 9 a.m. and 5 p.m., as follows: a. On 3/3/23: 9 a.m. entry: Code 10 entered by registered nurse (RN) A; 5 p.m. entry: Code 10 entered by RN B b. On 3/4/23: 9 a.m. entry: Code 10 entered by licensed vocational nurse (LVN) C; 5 p.m. entry: Code 10 entered by RN B The MAR's Chart Code indicated each number code had a different meaning, such as 1 = resident refused, 2 = resident not available. The 10 code meant "Other (specify)." A review of the corresponding nursing progress notes indicated the following: a. 3/3/23 at 9:21 a.m., RN A wrote "Keppra Tablet 500 mg...[dosing and frequency]... on order" b. 3/3/23 at 4:17 p.m., RN B wrote: "Keppra Tablet 500 mg... on order" c. 3/4/23 at 10 a.m., LVN C wrote: "Keppra Tablet 500 mg... on order" d. 3/4/23 at 4:28 p.m., RN B wrote: "Keppra Tablet 500 mg... on order" Further review of Resident 1's clinical record indicated the nursing progress notes, documented by RN B on 3/5/23 at 2:20 a.m., indicating: "3/4/23 at 2330, Resident started having seizures 5x [meaning 5 times] lasting more than 3 minutes. Turned resident on his side to avoid aspiration [accidental breathing in of food or fluid into the lungs]. VS [vital signs] taken. Afebrile [not feverish]. MD [physician] notified with order to send to ER [Emergency Room] for further eval[uation]..." A review of the 3/5/23 Emergency Medical Services (EMS) Prehospital Care Report w/o [without] Attachments, provided by the hospital, indicated: "Responded to seizures. Upon arrival pt [patient] found lying left lateral position... postictal [period of time immediately following a seizure]... Per staff pt has been witnessed to have multiple seizures starting at approx. 23:45 tonight. Per staff pt has a history of seizures... Pt is noted to have shaking of extremities and pt reports impending seizure. Pt is noted to have a full-body generalized seizure lasting approx. 2 minutes. Pt administered 2.5 mg Versed [medication to treat seizures] IM [intramuscularly, meaning deep muscle injection]... Pt is noted to be unresponsive... During transport pt remained altered and unstable. At hospital pt moved to Emergency Department..." A review of the acute care hospital's History and Physical (document that provides concise information about a patient's history and exam findings at the time of admission), date of service 3/5/23 at 4:55 a.m., indicated the hospital received Resident 1 for "Chief Complaint" of seizure. Under "History of Present Illness (HPI)", a hospital's physician wrote, "[Age of resident] year-old male, institutionalized due to multiple sclerosis, presents with seizures. He has a longstanding seizure disorder for which he takes Dilantin and Keppra. The patient had 2 seizures in the nursing home for which 911 was called. He seized again for paramedics and they gave him intramuscular Versed at least twice. Seizure. When the patient got to the emergency room. However he was postictal and unresponsive. Dilantin level was subtherapeutic [lower than normal range] and it turns out the nursing home ran out of Keppra 48 hours ago." Under "Plan", the H&P indicated, "[Age] year-old male... presents with seizures 48 hours after running out of his Keppra, also with a subtherapeutic Dilantin level. He will be admitted to [Name of Hospital] for loading of Dilantin and Keppra and resumption of both medications orally..." A review of the ED Physician Documentation, dated 3/5/23, indicated Resident 1 arrived on 3/5/23 at 1:06 a.m. via EMS. The ED physician wrote, on 3/5/23 at 1:11 a.m., "The patient presents with 'More seizures' tonight per nursing home staff... He was found postictal by EMS and then said he felt like he was when have a seizure and had a full-blown seizure with O2 [oxygen] as low as 75% [normal: 95% - 100%] at the end. Was given 2.5 mg of Versed..." and "3/5 4:00 [a.m.] Awaiting: History from the nursing home is helpful... it turns out they have not had Keppra since the 2nd so the patient has missed 48 hours of Keppra. They do not have any still. This is clearly at least contributing to why he is seizing. I will have to admit him since I can send him back to place the does not have the medicine to care for him." A review of the ED Nurse Documentation, dated 3/5/23 at 3:58 a.m., indicated: "Contacted Watsonville Nursing Center, spoke with [name of nurse]... It was also reported to this RN by [name of nurse] that the patient has not had any of his scheduled Keppra doses (patient is prescribed 1000mg Keppra BID [meaning twice daily] for seizure prevention), reported to RN that the last dose patient received was 3/2/23 evening, and has not had any dosed since then. It was reported that the facility had "ran out" and they were waiting for the pharmacy to deliver more..." Resident 1's clinical record indicated the resident was admitted to the hospital on 3/5/23 at 4:30 a.m., and discharged on 3/6/23 at 10:45 a.m. The nursing progress notes, dated 3/6/23, indicated he was re-admitted to the facility on 3/6/23 at approximately 2:50 p.m. A review of the hospital's Discharge Summary, dated 3/6/23, indicated the following under "Final Diagnoses": "Epileptic seizure related to external causes, not intractable [untreatable], without status epilepticus [prolonged seizure lasting longer than 5 minutes or when seizures occur close together and the person doesn't recover between seizures]... Uses less medication than prescribed... Patient's unintentional underdosing of medication regimen." The History Course in the Discharge Summary indicated, "...male with multiple sclerosis... Apparently they ran out of his seizure medications at the nursing facility. Seizures. Patient was admitted and received a loading dose [large dose of a medicine used to ensure a quick therapeutic response] of Dilantin and Keppra. By hospital day 2. The patient was alert and oriented and mentating at baseline." A review of the Medical Provider progress notes, written by Resident 1's attending physician (Physician A) on 3/7/23 at 9:56 p.m., indicated: "Seizure d/o [disorder]... Unfortunately was out of Keppra x 2 days and had recurrent seizures. Hospitalized and dilantin dose increased again. Discussed care with DON [director of nursing] re: missed medications... For now continue current doses of Dilantin and Keppra, may try to reduce Dilantin again in future." During an interview with Resident 1 on 3/17/23 at 1:27 p.m., Resident 1 stated he had been on Dilantin and Keppra for many months for seizure disorder. He stated the day he had the seizures he was very confused and did not know what was going on. He stated prior to that the nursing staff had told him they ran out of Keppra and were waiting for the pharmacy to deliver. He stated he told them he needed the medication, but they said they were still waiting for it to come. He stated he was not aware of what went on when he was at the hospital, but they put him back on the medications and sent him back. Resident 1 stated he was aware he had the seizures because he was missing a few days of Keppra. During an interview with RN A on 3/17/23 at 2:01 p.m., she confirmed she was the morning shift nurse on 3/3/23 and coded a "10" on the MAR for Resident 1's Keppra administration. She stated Code 10 meant "the medication was not available", and she ordered it through the facility's computerized system. She stated she informed Resident 1 the medication was not available. She continued, "I knew he had gotten it the day prior; he was stable, they didn't have the med." RN A stated she was not aware the medication was available in the facility's automatic dispensing cabinet (ADC, an automated machine where medications are stored and electronically tracked) so she could get it from there and did not inform the doctor. She confirmed she should have informed the doctor when Keppra was not available to give to the resident. RN A confirmed she was aware Resident 1 was hospitalized for seizures due to missing his Keppra when she was counseled by the DON on 3/10/23. On 3/17/23 at 2:16 p.m., the DON provided an inventory list of medications available in the facility's ADC. The list indicated the ADC contained 115 different medications including levetiracetam (Keppra) 250 mg tablets. During a telephone interview with the Pharmacist on 3/17/23 at 2:18 p.m., she stated the facility staff requested a refill for Keppra on 3/3/23 at 9:21 a.m. (this is consistent with the interview with RN A above) but it was not delivered until 3/5/23 at 4:13 p.m. (2 days later). She stated most of the refill requests were processed and delivered from a sister pharmacy in southern California, that was why it took two days to deliver. She stated, "We ask [facilities] for a few days to process refills. If they need medications urgently, they give us a call to [name of pharmacy] to send with the next run." The Pharmacist reviewed the pharmacy dispensing records and stated a 30-day supply of Keppra was delivered on 1/3/23 and on 3/5/23; there were no request for and delivery in February 2023. During a concurrent interview and record review with RN B on 3/17/23 at 3:09 p.m., she stated she coded a "10" on the Keppra 5 p.m. administrations on 3/3 and 3/4/23. When asked what Code 10 meant, RN B stated, "I think that was when we ran out of Keppra." She stated, "I was not able to call the doctor" on those days the medication was not available and could not recall whether she called the pharmacy to follow up. She stated she informed Resident 1 that they were waiting for the pharmacy to deliver. RN B reviewed the March 2023 MAR and confirmed she administered the last dose at 5 p.m. on 3/2/23, but she stated she could not remember if she ordered it. She confirmed when the medication supply was running low, the nursing staff was to re-order it 3 to 5 days ahead to allow time for the pharmacy to deliver. She also added that she was not aware the Keppra tablets were available in the ADC. RN B reviewed Resident 1's clinical record and confirmed both times, on 3/3 and 3/4/23 at 5 p.m. that she only documented "on order" in the nursing progress notes. During the interview above, RN B stated on the day of event, the aide called her about Resident 1 having a seizure. They ran to the resident's room, found him seizing, had him turned to his side, and probed a pillow on the wall to stop him from hitting the wall. She stated it lasted about 1 to 2 minutes, then it stopped, and he started seizing again that lasted more than 2 minutes. She called the doctor and asked to have him sent to the ER. RN B stated she was made aware Resident 1 experienced seizures because of the missing Keppra when she was counseled by the DON later that week. During a concurrent interview and record review with the DON on 3/17/23 at 3:50 p.m., the DON explained Resident 1 experienced the seizures on the weekend when he was out of Keppra for 2 days. She stated she was not aware he missed 4 doses. She stated, "The nurses notified me that he went to the hospital, but I was not aware about the Keppra until I reviewed his re-admission papers the next day [after the resident returned] that's when I noticed." The DON explained, "[RN A] re-ordered the Keppra on 3/3 [March 3rd] but the pharmacy delivered it on 3/5 by the time the resident was already in the hospital." The DON stated when the nursing staff ran out of the medication, they should be checking the ADC list to see if the medication is available in it; and if not, call the pharmacy to get it satellited (special delivery by a nearby pharmacy). She continued, "If that's not an option, to notify the doctor to get another medication [for the resident]." She stated, "They could have called the doctor to increase his Dilantin while waiting for Keppra." The DON reviewed Resident 1's clinical record and confirmed there were no documented evidence the nursing staff calling the physician or the pharmacy. The DON also said the staff should re-order the medications 3 to 5 days before they run o