Health inspection·September 8, 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. § 72523(a) Patient Care Policies and Procedures Written patient care policies and procedures shall be established and implemented to ensure that patient relate goals and facility objective are achieved. § 72355 - Pharmaceutical Service – Requirements (a) Pharmaceutical service shall include, but is not limited to, the following: (1) Obtaining necessary drugs including the availability of 24-hour prescription F7 (3) Monitoring the drug distribution system which includes ordering, dispensing and administering of medication. 22 CCR § 72313: Nursing Service--Administration of Medications and Treatments. (a) Medications and treatments shall be administered as follows: (2) Medications and treatments shall be administered as prescribed. (6) Medications shall be administered as soon as possible, but no more than two hours after doses are prepared and shall be administered by the same person who prepares the doses for administration. Doses shall be administered within one hour of the prescribed time unless otherwise indicated by the prescriber. On 7/24/2023 the California Department of Public Health (CDPH) received a compliant indicating the facility had no Glucagon (medication to reverse low blood sugar levels) for Resident 1, a 46-year-old male, who had a hypoglycemic (blood sugar [BS] level is lower than the body’s needs) episode and had a BS of 59 milligrams per deciliter [(mg/dl) – a unit of measurement of weight]. The BS reference range is 80 mg/dl to 130 mg/dl). On 7/26/2023, at 10:18 a.m., an unannounced visit was made to the facility to investigate the complaint allegation related to Resident 1. Upon investigation it was determined the Licensed Vocational Nurse (LVN 1) was not trained and had no knowledge on how to operate an automated medication machine (AMM) Emergency Kit (E-KIT) during emergencies to retrieve Glucagon. The facility failed to: 1. Ensure LVN 1 was properly trained to retrieve Glucagon from the AMM E-KIT utilizing the “override” function, to administer it to Resident 1 a 46-year-old man when the resident was found unresponsive with a BS of 59 in accordance with facility’s policy and procedure titled “Facility Assessment Tool”. 2. Ensure LVN 2 assisted LVN 1 to retrieve the Glucagon for Resident 1 from the AMM E-KIT after it was clear that LVN 1 was unable to retrieve the Glucagon from the AMM E-Kit. These failures resulted in Resident 1’s blood sugar level dropping to 25 mg/dl and the resident’s transfer to a general acute care hospital (GACH) due to acute (severe and sudden onset) hypoglycemia placing Resident 1 at high risk for having seizures (uncontrolled, abnormal electrical activity of the brain that may cause changes in the level of consciousness, behavior, memory, or feelings), going into a coma (a state of unconsciousness where a person is unresponsive and cannot be awoken), and possible death. A review of Resident 1’s Admission Record, indicated Resident 1 was admitted to the facility on 4/8/2023 with diagnoses including end stage renal disease (a medical condition in which a person's kidneys cease to filter out toxins from the blood, leading to the need for a regular course of long-term mechanical filtering or a kidney transplant to maintain life), hypoglycemia, seizures, diabetes mellitus (a condition that affects the body’s ability to process blood sugar to maintain health), and hypertension (high blood pressure). A review of Resident 1’s Minimum Data Set [(MDS), a standardized assessment and care screening tool] dated 5/17/2023, indicated Resident 1’s cognitive (process of thinking) skills for daily decision-making were moderately impaired. The MDS indicated Resident 1 required extensive assistance with bed mobility, toilet use, bathing, personal hygiene, and eating. The MDS indicated that Resident 1 was usually understood and was able to understand others. A review of Resident 1's physician’s orders (PO) dated 7/14/2023, indicated the following: 1. Administer Glucagon 1 mg from Emergency Kit, intramuscularly [(IM) a technique used to deliver a medication deep into the muscles] every 15 minutes as needed for hypoglycemic symptoms, difficult to arouse or unconsciousness. Administer immediately, repeat blood glucose (sugar) test BS in 15 minutes, if no response (an increase in blood sugar level) to the first dose administered, repeat Glucagon 1 mg, if no response to the second dose, administer another dose in 15 min and repeat blood glucose (sugar) test and start intravenous [(IV) method of delivering medications and fluids through a vein) access, if not presently established. 2. Insulin Glargine (a long-acting medication used to control blood sugars that lasts in the body for 24 hours) subcutaneous [(SQ) beneath all the layers of the skin] solution with concentration of 100 units per milliliter [(u/ml) medication concentration], inject 20 units SQ at bedtime for diabetes mellitus (DM). 3. Insulin Lispro (a fast-acting medication used to control blood sugars) injection solution 100 u/ml, inject SQ before meals and at bedtime based on a sliding scale (amount of medication depends on results of BS) as follows: A. For blood sugar level 70-150 mg/dl-administer zero units. B. For blood sugar level 151-200 mg/dl- administer three units. C. For blood sugar level 201-250 mg/dl-administer six units. D. For blood sugar level 251-300 mg/dl-administer nine units. E. For blood sugar level 301-350 mg/dl-administer 12 units. F. For blood sugar level 351-400 mg/dl-administer 15 units. G. For blood sugar level greater 401mg/dl-administer 18 units and call Medical Doctor (MD) A review of the facility’s AMM inventory list, dated 7/22/2023 and timed at 8:22 a.m., indicated the AMM had four prefilled pens of Glucagon medication in stock. A review or Resident 1’s electronic medical record (eMAR), dated 7/21/2023, indicated Resident 1 received three units of Insulin Lispro and 24 units of Insulin Glargine at 9:00 p.m. A review of Resident 1’s change of condition (COC – a documentation of vital medical information of a resident’s sudden change of condition from baseline) report, dated 7/22/2023 at 5:00 a.m., indicated Resident 1 was found unresponsive with a BS of 59 mg/dl. A review of Resident 1's PO, dated 7/22/2023 and timed at 5:09 a.m., indicated to transfer Resident 1 to the emergency room (ER) for further evaluation due to Resident 1’s unresponsiveness and low BS. A review of Resident 1’s Transfer Form (TF), dated 7/22/2023 and timed at 5:15 a.m., indicated Resident 1 was transferred to the GACH by paramedics (healthcare professionals who respond to emergency calls for medical help). A review of Resident 1’s GACH History of Present Illness (HPI), dated 7/22/20223 and timed at 5:18 a.m., indicated paramedics administered Glucagon 1 mg to Resident 1 at the facility for BS of 25 mg/dl, and Resident 1’s Glasgow Coma Scale ([GCS] a clinical scale used to reliably measure a person’s level of consciousness after a brain injury, severe -8 or less, moderate-9 to 12, mild-13 to 15) was a 3. According to the HPI paramedics transferred Resident 1 to the GACH for an acute hypoglycemic episode and upon Resident 1’s arrival to the GACH the resident had returned to his baseline (normal state of being). During a concurrent observation and interview with the Registered Nurse (RN 1) on 7/26/2023 at 2:43 p.m., RN 1 stated, “the AMM is the facility’s E-kit, and it is where staff can obtain the necessary medications they need during an emergency.” RN 1 stated that all residents with diagnoses of diabetes have a standing order (permanent PO in place, to avoid a delay in care during emergencies) for Glucagon and the licensed nurses can get this medication by going to the EMM, accessing the specific resident’s list of medications information section ([resident’s profile] information stored in the AMM about a resident’s medication, dosage and frequency) or overriding (taking manual control of the AMM to access medication) the system in the event of an emergency. During an interview with LVN 4 on 7/26/2023 at 2:56 p.m., LVN 4 stated, “if a diabetic resident appeared that something wrong (being unresponsive),” he would first check the resident’s BS to verify that if it was low, then check if there was a PO to administer Glucagon, then go to the AMM to retrieve this medication, and administer the Glucagon to the resident. LVN 4 stated the PO could indicate to repeat the process if the resident did not respond to the first dose of Glucagon, “just depends on what the order states.” During an interview with LVN 1 on 7/27/2023 at 6:24 a.m., LVN 1 stated that when Resident 1 was found unresponsive and had a low blood sugar, he came to the AMM to retrieve Glucagon, while LVN 2 was calling 911. LVN 1 stated that he was not able to retrieve the medication because the AMM indicated the Glucagon was out of stock. LVN 1 stated, at that time, he did not know about the ‘override’ function that would have allowed him to access the emergency Glucagon. During an interview with LVN 2 on 7/27/2023 at 7:10 a.m., LVN 2 stated that LVN 1 asked her to call 911 while LVN 1 was attempting to retrieve the Glucagon from the AMM. LVN 2 stated that LVN 1 was struggling to retrieve the Glucagon and that LVN 1 went back to Resident 1 without the medication. LVN 2 stated she was aware of the override function but did not help LVN 1 because, “I was gathering documents so it can be ready for the paramedics.” During a concurrent observation and interview with LVN 3 on 7/27/2023 at 7:28 a.m., LVN 3 was able to demonstrate the AMM override function. LVN 3 stated before working on the floor licensed staff usually get training on how to use the AMM and the override function. During an interview with the DON on 7/27/2023 at 9:20 a.m., the DON stated LVN 1 should have accessed “stock medications” in the AMM to retrieve the emergency Glucagon. The DON stated that LVN 1 “panicked,” and LVN 1’s main concern was to be with Resident 1 at that time. The DON stated LVN 1 was trained on how to use the AMM and the override function right after Resident 1’s hypoglycemic event on 7/22/23, 5:00 a.m. The DON stated that if the resident does not receive the Glucagon in a timely matter, the outcome could be fatal. A review of the facility’s document titled “LVN Job Description”, revised May 2022, indicated the LVN must attend and participate in continuing education programs. The document also indicated that LVNs must demonstrate the knowledge and skills necessary to provide care appropriate to the age-related needs of the residents serve and the LVN must be able to cope with mental and emotional stress of the position. A review of the facility’s undated document titled “Facility Assessment Tool” (a tool for the facility to evaluate its resident population and identify the resources needed to provide necessary person-centered care and services the facility residents require), indicated that nursing staff are checked for competency skills and if they are deemed competent then they are assigned to the unit that they meet qualifications for. The document also indicated that competency skills evaluations are checked upon hiring and annually thereafter. Performance evaluations are performed annually to ensure staff is meeting the facility’s standards of performance and conduct. The facility failed to: 1. Ensure LVN 1 was able to retrieve Glucagon from the AMM E-KIT, to administer it to Resident 1 when the resident was found unresponsive with a BS of 59. 2. Ensure LVN 2 assisted LVN 1 to retrieve the Glucagon for Resident 1 from the AMM E-KIT when LVN 1 was unable to retrieve the Glucagon These failures resulted in Resident 1’s blood sugar level dropping to 25 mg/dl and the resident’s transfer to a GACH due to acute hypoglycemia placing Resident 1 at high risk for having seizures going into a coma, and possible death. These violations, jointly, separately or in any combination, presented either imminent danger that death or serious harm would result or a substantial probability that death or serious physical harm would result for Resident 1.