Other·November 20, 2024

REGULATION VIOLATIONS Health & Safety Code 1424 (c) and (d) (c) Class "AA" violations are violations that meet the criteria for a class "A" violation and that the state department determines to have been a direct proximate cause of death of a patient or resident of a long-term health care facility. Except as provided in Section 1424.5, a class "AA" citation is subject to a civil penalty in the amount of not less than five thousand dollars ($5,000) and not exceeding twenty-five thousand dollars ($25,000) for each citation. In any action to enforce a citation issued under this subdivision, the state department shall prove all of the following: (1) The violation was a direct proximate cause of death of a patient or resident. (2) The death resulted from an occurrence of a nature that the regulation was designed to prevent. (3) The patient or resident suffering the death was among the class of persons for whose protection the regulation was adopted. If the state department meets this burden of proof, the licensee shall have the burden of proving that the licensee did what might reasonably be expected of a long-term health care facility licensee, acting under similar circumstances, to comply with the regulation. If the licensee sustains this burden, then the citation shall be dismissed. (d) Class "A" violations are violations which the state department determines present either (1) imminent danger that death or serious harm to the patients or residents of the long-term health care facility would result therefrom, or (2) substantial probability that death or serious physical harm to patients or residents of the long-term health care facility would result therefrom. Title 42, Code of Federal Regulations, Section §483.45, subdivision (f) (2): The facility must ensure that its §483.45(f)(2) Residents are free of any significant medication errors. 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. (f) Medication errors. The facility must ensure that its - (2) Residents are free of any significant medication errors Title 22, California Code of Regulations, Section 72313, subdivisions (a) (2), (3), and (7), and (b): (a) Medications and treatments shall be administered as follows: (2) Medications and treatments shall be administered as prescribed. (3) Tests and taking of vital signs, upon which administration of medications or treatments are conditioned, shall be performed as required and the results recorded. (7) Patients shall be identified prior to administration of a drug or treatment. (b) No medication shall be used for any patient other than the patient for whom it was prescribed. The Facility failed to administer medications as prescribed to a patient, failed to identify a patient prior to administration of a drug, failed to monitor vital signs upon administration of the wrong medication to a patient, failed to ensure medication prescribed for one patient was not administered to another patient, and failed to ensure a patient was free from significant medication error when: (1) A licensed nurse from the Facility administered a wrong medication to Resident 1. Specifically, Suboxone (used to treat pain and addiction to narcotic pain relievers) was administered to Resident 1 but was not medication prescribed by a physician for Resident 1. (2) A licensed nurse failed to monitor Resident 1's vital signs ("VS") [(VS) clinical measurements, specifically pulse rate, respiration rate, blood pressure, and temperature, that indicate the state of a resident's essential body functions] following the administration of the wrong medication to Resident 1. These failures led to the hospitalization of Resident 1 in the Intensive Care Unit (ICU) at a General Acute Care Hospital due to an altered level of consciousness (a disruption in how the brain works that causes a change in behavior), ventricular tachycardia (rapid heart rate), aspiration pneumonia (inhale of food into your lungs), rhonchi (harsh, rattling sounds that resemble snoring) in the right and left lower posterior lungs, and hypotension (low blood pressure) that ultimately resulted in the death of Resident 1. FINDINGS On 9/16/19, a complaint was called in to the District Office alleging Resident 1 passed away because staff administered Resident 1 another resident's medication and Resident 1 overdosed. On 9/26/19, an onsite survey occurred at the facility. Upon arrival at the facility, Resident 1's clinical records were reviewed, including the "Face Sheet," "Initial Visit: History and Physical," and "History and Physical Examination," dated August 28, 2019. These documents recorded Resident 1's admission to the Facility on August 27, 2019, with the following diagnoses: (1) COPD [(Chronic Obstructive Pulmonary Disease) of the lungs. A group of lung diseases that makes it difficult to breath], (2) COPD exacerbation (symptoms flared up) due to right sided pneumonia (an infection that inflames the air sacs in one or both lungs), (3) atrial fibrillation (fluttery heartbeat because your blood is not moving well through the heart); and, (4) high blood pressure. The clinical record further documented that Resident 1 was transferred from an acute care facility to the Facility for physical deconditioning (prolonged bed rest and inactivity can cause a decline in function of one's body parts and systems). Resident 1 was receiving physical therapy to regain her strength following her hospitalization. Resident 1's "Baseline Care Plan," dated 8/27/19, and "Baseline Assessment," dated 8/27/19, documented Resident 1 was alert, oriented to person, place, and time, able to make needs known, able to follow simple commands, and able to understand others. Resident 1's "Change of Condition," dated 9/4/19, documented Resident 1 was administered the wrong medication, Suboxone 8 milligrams (mg) - 2 mg film on 9/4/19 at 12 p.m. During a concurrent medical record review and interview with Licensed Staff B on 10/6/19 at 5:50 pm, Licensed Staff B reported that on 9/4/19 at 10:00 a.m., Resident 1 was due to receive her dose of Clotrimazole Troche (antifungal medication given to treat yeast infection of the mouth and throat), which was stored in the narcotics drawer. Licensed Staff B further reported she failed to administer Clotrimazole Troche to Resident 1 as prescribed at 10:00 a.m. Licensed Staff B stated that at 12:00 pm. on September 4, 2019, she realized she had failed to administer the 10:00 a.m. dose of Clotrimazole Troche to Resident 1 and panicked. Licensed Staff B further confirmed during interview that without reviewing Resident 1's Medication Administration Record ("MAR"), Licensed Staff B pulled Suboxone 8 milligrams (mg) - 2 mg film from the narcotics drawer and administered it to Resident 1. The "Disposition of Controlled Drugs: Tabs/Caps Controlled Substances Inventory" for Suboxone 8 milligrams (mg) - 2 mg film documented the medication was to be given to another resident in a neighboring room at 2 p.m. Licensed Staff B further stated during the interview on 9/6/19 at 5:50 p.m. that Resident 1 was up in a chair in her room when she was given the wrong medication, Suboxone, at 12 p.m., but not at 2 p.m. Resident 1 was placed in her bed because she had become drowsy and wanted to take a nap. During an interview on 9/26/19 at 2:50 p.m., Administrative Staff A confirmed that Resident 1 was given the wrong medication, Suboxone, and Licensed Staff B could not explain why she administered Resident 1 Suboxone. Administrative Staff A stated the resident who was supposed to receive Suboxone was in the room next door to Resident 1 and the medication was to be given at 2 p.m., but was given to Resident 1 at 12 p.m. The "Interdisciplinary Team (IDT) Conference Review," dated 9/5/19, documented that on 9/4/19 at 12 p.m., Licensed Staff B notified the DON (Director of Nursing) she had administered the wrong medication, Suboxone, to Resident 1. The NP (Nurse Practitioner), contracted under Resident 1's physician, assessed Resident 1 on 9/4/19 at 1:49 p.m. The IDT documented the NP communicated to both Licensed Staff B and the DON that there should be no concern other than Resident 1 being in a transient (short lived) sedation (state of calm or sleep), and to Monitor Resident 1. The NP's electronic assessment contained no other concerns, instructions, or orders, nor did it record any further details of the NP's verbal communications with the DON and/or LVN. During a concurrent interview and record review on 11/7/19 at 3:30 p.m., the NP stated she entered the facility on 9/4/19, starting around 1-1:15 p.m., to make rounds on other residents, not Resident 1, when the DON informed her Resident 1 had received the wrong medication, Suboxone. The NP stated she checked on Resident 1. The NP stated when she assessed Resident 1, she was up in her chair watching television and she had just finished lunch. The NP stated Resident 1 was alert and answered questions appropriately. Resident 1's "History of Present Illness," dated 9/4/19, indicated Resident 1 was breathing at room air and was not in any distress. NP stated she told Licensed Staff B to, "monitor [Resident 1] closely." When asked during the interview what the NP meant by "monitor...closely," the NP stated to her professional standards would be to take VS at least every 4 hours, not every 8 hours. When the NP was asked about Resident 1's VS on 9/4/19 at 10 p.m. (BP 109/66, pulse 60 beats/min, respirations 10 breaths/min and saturation level 91% on room air), she stated the PM nurse should have called Resident 1's physician due to her abnormal VS, and because Resident 1 was very sedated; the nurses should have been taking Resident 1's VS more often than every 8 hours. During the interview, the NP further stated she had not received a call from a nurse until the following morning (9/5/19) around 6 a.m. about Resident 1's abnormal VS/Sat Level. The NP stated she ordered for Resident 1 to be transferred to the acute care facility right away to be evaluated. The NP stated she had told nursing staff and the DON to monitor Resident 1 closely. During an interview on 10/3/19 at 4:25 p.m., the DON stated that during her interview with Licensed Staff B on 9/5/22, Licensed Staff B explained she did not look at Resident 1's MAR while she was preparing Resident 1's medication. The DON further stated during the interview that Licensed Staff B did not follow "Nursing Standards of Practice" for administering a medication and that Licensed Staff B did not check the medication label against the entry on the MAR, being sure that the name, route, dose, and time matched, which led to administration of the wrong medication, Suboxone, to Resident 1. The facility policy/procedure titled, "Medication - Administration," revised 1/1/12, indicated: 1. The Licensed Nurse will verify the resident's identity before administering the medication, 2. Nursing Staff will keep in mind the seven "rights" of administering medication: "The right medication, the right amount, the right resident, the right time, the right route..." A copy of this policy/procedure was provided on 9/26/19 and confirmed to be the policy/procedure in effect at the time of the incident. During a concurrent record review and interview with Licensed Staff B on 10/6/19 at 5:05 p.m., Resident 1's clinical record titled, "Change of Condition" dated 9/4/19 at 12 p.m., was reviewed. This record documented Resident 1's VS at time Licensed Staff B administered the wrong medication, Suboxone, to Resident 1 were as follows: blood pressure (BP) 110/60 (Normal BP: 120/80), pulse 82 [average for an 88-year-old female was 72 beats/minutes (min)], and 18 breaths/min (normal rate at rest is 12 to 18 breaths per min). A review of Residents 1's clinical record titled, "Resident Baseline Evaluation," dated 8/27/19, indicated Resident 1's BP was 114/68, pulse 92 beats/min, and respirations were 16 breaths/min. Licensed Staff B stated during the interview on 10/6/19 that she had reported giving Resident 1 the wrong medication, Suboxone, to the nurse who was assigned to care for Resident 1 on the PM shift (2:30-11 p.m.) of 9/4/19, and explained to the PM nurse that Resident 1 needed to be "monitored closely." When Licensed Staff B was asked when the PM nurse should have taken Resident 1's VS, Licensed Staff B stated near the start of the PM Shift, around 4 p.m. Resident 1's MAR, dated 9/4/19, documented Resident 1's medications were held at 6 p.m., 8 p.m. and 10 p.m., because she was somnolent (drowsy). Resident 1's "Licensed Nurses Notes," dated 9/4/19 at 10 p.m., documented Resident 1's VS were taken at 10 p.m., not 4 p.m. BP was 109/66, pulse 60 beats/min, respirations 10 breaths/min and saturation level [(Sat Level) measurement of oxygen in the blood) at room air was 91% (Normal level for a healthy adult on room air is 94-99%). Resident 1 was aroused to verbal stimuli, but quickly went back to sleep. Resident 1's medications were held for safety because Resident 1 had difficulty swallowing. No other documentation on the PM Shift of 9/4/19, indicated Resident 1 was being monitored or whether Resident 1's physician or the NP were notified regarding Resident 1's abnormal respiration of 10 breaths/min and saturation level of 91%. During a concurrent interview and record review on 10/3/19 at 4:25 p.m. and 10/7/19 at 1:32 p.m., the DON stated she would have been concerned about Resident 1's abnormal respiration of 10 breaths/min and saturation level of 91%, if informed of that information. The DON stated she would have called Resident 1's physician if she was the nurse caring for her, and she would have checked Resident 1's VS more frequently. The DON stated when a resident had a "Change of Condition," the resident's VS were taken at least once a shift (every 8 hours). The DON stated the PM nurse should have made sure Resident 1's VS were taken within the first 2 hours of the PM Shift (by 5 p.m.). During a concurrent interview and record review on 11/18/19 at 7:26 p.m., Licensed Staff E stated she was working the Night Shift on 9/5/19. Licensed Staff E stated the PM nurse, who gave her report at the change of shift, stated Resident 1 had been given the wrong medication, Suboxone, on the AM Shift, but was doing well. Licensed Staff E stated the PM nurse did not inform her of Resident 1's abnormal VS (BP was 109/66, pulse 60 beats/min, respiration 10 breaths/min and saturation level at room air was 91%) taken on 9/4/19 at 10 p.m. Licensed Staff E further stated during interview that she could not understand why Resident 1's physician was not notified about the abnormal VS or why Resident 1's VS were taken so late on the PM Shift (10 p.m.). Licensed Staff E stated if she had been made aware of Resident 1's VS, she would have called her physician right away. Licensed Staff E stated she checked on Resident 1 twice during the Night Shift, the first time Resident 1 appeared asleep. Licensed Staff E stated she did not take Resident 1's VS at that time. Licensed Staff E stated, when she went to pass her early morning medications on 9/5/19, she checked on Resident 1 for the second time and noticed she had a brown substance (like pudding) on the side of her mouth, she was not responding, she was struggling for air, and Resident 1's VS were abnormal. Licensed Staff E stated if she had been told to monitor Resident 1 closely, she would have taken her VS every 2 hours, but the PM nurse did not inform her Resident 1 needed to be monitored closely. An examination and review of Resident 1's clinical records at the facility demonstrated that there was no documentation indicating Licensed Staff E and CNAs were monitoring Resident 1 after 10 p.m. on 9/4/19 until 9/5/19 at 5:58 a.m. Resident 1's "SBAR (Situation, Background, Appearance, Review and Notify) Communication Form," dated 9/5/19 at 5:58 a.m., documented Resident 1's VS were: BP 150/100, pulse ranged from 64 to 166 beats/min, re