Health inspection·August 6, 2021

The following reflects the findings of the California Department of Public Health during the Re-Certification survey from 7/19/21 to 7/26/21: Event ID: J24F11 Representing the Department, PCII # 27000 State Citation B was written 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 ensure pharmaceutical services were provided as ordered, timely, accurately, and safely for three of 26 sampled residents (Residents 29, 75, and 82) and four residents (Residents 26, 69, 123 and 327) as evidenced by: 1. Medications ordered by the physician were not available in the medication cart for administration to Residents 29, 82, 123, and 327. The nursing staff did not re-order and receive pain medication from the pharmacy timely for Residents 123 and 327, resulting in the residents suffering from the pain. Resident 29 did not receive his daily sevelamer (a phosphate binder, medication to control high blood level of phosphorus, a mineral found in food, in people with kidney disease who are on dialysis) for more than two months; and the nursing staff documented sevelamer given to the resident without actually giving the medication. The nursing staff did not notify the physician when the medication was not available to give to Resident 29. Resident 82 did not receive his inhalers (to treat breathing problems), Xifaxan (medication to help prevent recurrence of certain liver problems), and gabapentin (nerve pain medication) as ordered; and the nursing staff did not notify the physician when the medications were not available to give to Resident 82. These failures resulted in Residents 123 and 327 suffering from pain; Resident 82 suffering from asthma (inflammatory disease of the airways to the lungs) attacks and potential for worsening of his other medical conditions; and the potential for Resident 29 to suffer from high phosphate concentration in the blood. 2. Random controlled medication (those with high potential for abuse and addiction) use audit for three out of three residents (Residents 75, 123, and 327) did not reconcile. The medications were signed out of the Controlled Drug Record (CDR, an inventory sheet that keeps record of the usage of controlled medications) but did not document on the Medication Administration Record (MAR) to indicate the controlled medications were given to the residents. This failure had the potential for misuse or diversion of controlled medications. 3. During the medication pass observation, one of four nurses prepared and was about to administer medications for two residents (Residents 26 and 69) at the same time. This failure had the potential for medication errors due to the resident mix-up; and 4. Four of four opened emergency kits (E-kit, a kit/box containing medications and supplies for immediate use during a medical emergency) were not replaced in a timely manner as in accordance with the facility policy and procedures (P&P). This failure had the potential for the residents not receiving emergency medications, if needed, in a timely manner. Findings: 1a. During the medication pass observation with licensed vocational nurse (LVN) B on 7/19/21 at 9:45 a.m., Resident 123 was observed in a wheelchair outside in the hallway, near LVN B's medication cart. Resident 123 requested to have his Norco (a controlled medication for pain) with his morning medications. LVN B looked through the medication cart and said he could not locate the Norco for Resident 123. He said the resident asked for it earlier that morning for the pain level of 6 (moderate pain; using the Numeric Rating Scale; scoring range, 0-10; 0 = no pain, 10 = worst pain possible). On 7/19/21 at 9:50 a.m., LVN B was observed administering the morning medications to Resident 123 but there was no Norco given. During an interview on 7/19/21 at 9:57 a.m., Resident 123 stated he requested for the Norco earlier that morning. He pointed to his left shoulder and stated he had a pain level of 9 (severe pain) on his left shoulder. A review of Resident 123's medical record indicated he was admitted to the facility with diagnoses including left shoulder pain. The physician's Progress Notes, dated 6/22/21, indicated: "Left shoulder pain OA [osteoarthritis - type of arthritis that occurs when flexible tissue at the ends of bones wears down]." The medical record indicated a physician's order, dated 6/9/21, for Norco 5-325 mg (combination of hydrocodone 5 mg and acetaminophen 325 mg) 1 tablet every 6 hours as needed for moderate pain. A review of Resident 123's Minimum Data Set (MDS, an assessment tool), dated 6/25/21, indicated Resident 123 had the Brief Interview for Mental Status (BIMS, a test given by medical professionals that helps determine a patient's cognitive understanding that can be scored from 1, which is the lowest score, to 15, which is the highest score) score of 13, indicating the resident had intact cognition. During a follow-up interview on 7/19/21 at 11:46 a.m., with LVN B, he stated the physician's order for Norco was changed from one tablet every 8 hours as needed, to every 6 hours as needed on 6/9/2021 "but no one informed the pharmacy." He said the last tablet was used last night on 7/18/21. He said he called the pharmacy this morning, the pharmacy told him that they could not refill the Norco until they talked with the doctor and would not authorize the use of the E-kit. LVN B said he did not have the Norco to give to the resident; he offered to give Tylenol but the resident refused. During an interview with LVN E on the following day, on 7/20/21 at 12:03 p.m., she stated the facility had not received the Norco for Resident 123 yet. During an interview with the assistant director of nursing (ADON) on 7/20/21 at 12:12 p.m., she stated she in-serviced the nursing staff to request refills for medications when they had five days' worth of medications on hand for routine and for as-needed medications based on pattern of use. She stated the facility ran out of the Norco for Resident 123 because the nursing staff failed to request the refill and follow up with the pharmacy timely and did not report to her when they were running low on Norco. During a telephone interview with the pharmacy staff (PS) on 07/21/21 at 4:18 p.m., PS said the pharmacy delivered 30 Norco tablets for Resident 123 on 6/25/21, and the facility made a refill request for Norco on 7/13/21, but the pharmacy had been trying to get the clarification for the direction change but was not successful until 7/20/21 (day of survey). There was no documented evidence the nursing staff followed up the pharmacy during from 7/13/21 to 7/19/21 to ensure they received the Norco timely. The ADON confirmed this during the interview on 7/20/21 at 12:12 p.m. as described above. 1b. On 7/20/21 at 8:31 a.m. in the presence of LVN C in the hallway of Nursing Unit 6, Resident 327 was overhead crying in her room. She sobbed out loud and said, "Hurts too much!" On 7/20/21 at approximately 8:35 a.m., LVN C was observed opening and taking one tablet of Norco 5-325 mg from the controlled medication E-kit. He said he was waiting for the pharmacy to deliver the Norco for Resident 327. On 7/20/21 at 8:45 a.m., LVN C was observed administering the Norco to Resident 327 while she was crying and twisting her body in pain. She said her pain level was a 10 out of 10 (severe pain); and the pain was "burning in my knees... Hurts so much!" During a concurrent observation and interview with Resident 327 on 7/20/21 at 8:48 a.m., she was observed turning and twisting in pain, crying, and apologizing for crying. She said the pain was too much, burning on her left leg. She said she usually got her Norco around 7 a.m. and said if she did not get it on time, "then the pain just builds up." A review of Resident 327's medical record indicated a physician's order, dated 7/14/21, for Norco 5-325 mg, 1 tablet every 6 hours as needed for severe pain. During an interview with LVN C on 7/20/21 at 11:01 a.m., he said it was his first time working in this unit. He did not know what happened to the Norco for Resident 327. He said he could not find it this morning, that the last Norco tablet was used last night by the night-shift nurse. During an interview with the ADON on 7/20/21 at 12:12 p.m., she said the night nurse gave the last dose at 3 a.m. but did not document it on the MAR, and also did not report that was the last dose. She said the staff did not request the refill from the pharmacy timely. Therefore, the medication was not available for the resident, causing the delay in administration. On 7/19/21, a review of Resident 327's medical record indicated she was admitted to the facility, on 7/14/21, with diagnoses including cellulitis (common, potentially serious bacterial skin infection) of right lower limb, cellulitis of left lower limb, lumbago with sciatica (pain radiating along the sciatic nerve, which runs down one or both legs from the lower back), and "unspecified open wound" on right knee and right lower leg. Her MDS, dated 7/20/21, indicated she had a BIMS score of 15, indicating she had intact cognition. During a follow-up interview with Resident 327 on 07/21/21 at 3:49 p.m., she said she lived in a van and fell when she missed a step, something punctured her legs, and woke up in pain following the accident. She was hospitalized prior to being admitted to the facility. The resident was observed with three covered wounds on both legs: two on her right leg and one on the lower part of the left leg. She said yesterday (7/20/21) she received the Norco two hours after she requested it and by the time she got it the pain had already set in, and was in pain the whole day, more in the wound on the left leg. She again said the pain level was 10 out of 10, and it was "burning the skin off my bone. It was excruciating!" She said she received more Norco later in the afternoon, but it messed up her schedule and was in pain the entire a day. She said the nurse had to bring her the commode (a portable toilet) to use at the bedside last night because she was debilitated by the pain. Normally she would be able to use the restroom all by herself. 1c. During a medication pass observation on 7/20/21 at 9:36 a.m. with LVN C, he was observed preparing medications for Resident 29 in Nursing Unit 6. He was looking through the medication cart and said he could not find two medications. LVN C said he could not find the sevelamer 0.8 gram (unit of measurement), which was scheduled to be given daily at 9 a.m. He said he looked everywhere, including the medication room, but could not find it. During a review of Resident 29's medical record, it indicated he was admitted to the facility, on 4/29/21, with diagnoses including end-stage renal disease (ESRD, a longstanding kidney failure). It showed the resident had been receiving dialysis (a machine filters wastes, salts and fluid from your blood when your kidneys are no longer healthy enough to do this work adequately) three times per week since admission. The MDS, dated 5/6/21, indicated he had a BIMS score of 15, indicating the resident had intact cognition. A review of Resident 29's medication orders included an order, dated 4/29/21, for sevelamer (brand name: Renvela) 0.8 gram (gm, unit of weight) powder packet, give 1 packet (0.8 gram) via G-tube (a tube inserted through the abdomen that delivers nutrition and medications directly to the stomach) daily for ESRD. A review of the Prescribing Information (detailed description of a drug's uses, dosage range, side effects, drug-drug interactions, and contraindications that is available to clinicians) for sevelamer, revised 7/2021, indicated it is a phosphate binder which works by binding with the phosphate (or phosphorous, found in food) in the gastrointestinal tract and thus decreasing the phosphorous absorption in the blood. During a follow-up interview the following day with LVN C, on 07/21/21 at 10:18 a.m., he said the facility had not received the sevelamer for Resident 29 yet. A review of Resident 29's July 2021 MAR indicated sevelamer was scheduled to be given daily at 9 a.m. It showed LVN C circled the MAR entry on 7/20/21 and 7/21/21 for sevelamer administration. On the back of the MAR, LVN C wrote, "Sevelamer 0.8 gm waiting delivery. MD made aware" on 7/20 at 9 a.m. and 7/21/2021 at 9 a.m. During another interview with LVN C on 7/21/21 3:14 p.m., he said he had not received the sevelamer yet. He said he called the physician who said to monitor the resident for any changes and to give when available. A review of LVN C's Progress Notes, documented on 7/21/21 at 8:45 p.m., indicated in part, "Patient missed 2 doses of Sevelamer 0.8 gr [grams]. MD made aware and per MD to monitor for s/s [signs and symptoms] of distress. Spoke with [dialysis nurse' (DN) name] from [dialysis center name] dialysis, and per [DN's name] to resume medication as ordered, she will inform the dialysis MD, and labs will be done this week..." During a telephone interview with PS on 07/21/21 at 4:18 p.m., she said the pharmacy record showed the pharmacy delivered 14 packets (14-day supply) of sevelamer for Resident 29 on 4/30/21, and another 14 packets today (7/21/21). On 7/21/21, a review of Resident 29's May to July 2021 MARs indicated the nursing staff documented they had been administering the sevelamer almost every day in May except on 5/1 to 5/4/2021 (MAR entries were left blank); every day in June except there were 9 days (on 6/7 – 6/9; 6/14, 6/18, 6/19, 6/21, 6/26, and 6/27) where the staff circled their initials without explanation on the back of the MAR; and every day in July except 7/20 and 7/21/21 (where LVN C had circled MAR entries indicating the medication not available.) On 7/22/21 at 9:15 a.m., the consultant pharmacist (CP) provided the dispensing record for Resident 29's sevelamer. It indicated the pharmacy dispensed 14 packets on 4/30/21, and another 14 packets on 7/21/21 (day of survey). During an interview with LVN G on 7/22/21 at 10:55 a.m., she said she believed Resident 29 received his medications through the facility's pharmacy only. She said any time the medication was not available; the nursing staff was to follow-up with the pharmacy and make a circle around their initials on the MAR to indicate the medication not given. She said they were supposed to write on the back of the MAR the reason, such as medication not available or resident refused, whenever the medication was not given. She said she noticed the nursing staff just circled the MARs and not writing the reason in the back of the MAR for all the residents. During an interview with Resident 29 on 7/22/21 at 11:10 a.m., he said he was not familiar with sevelamer. He said the staff usually did not tell him what they gave him. He said he thought he had been getting his medications every day. Resident 29 confirmed he had been getting his medications through the facility only; there were no family members or other sources where his medications might have come from. During an interview with the CP on 7/22/21 at 11:20 a.m., she said she reviewed Resident 29's medical record and