Inspector’s narrative
What the inspector wrote
One State A level citation #11-2888-16512 was issued for CA00622285 and CA00622752.
0955 Nursing Services-Administration of Medication - T22 DIV5 CH3 ART3-72313(b)
(b) No medication shall be used for any patient other than the patient for whom it was prescribed.
The facility failed to ensure medication was used only for patients for whom it was prescribed, when one of three sampled residents, Resident 1, was found unresponsive and with vital signs below normal limits, resulting in a five-day hospitalization, at the beginning of which Resident 1 tested positive for an opioid analgesic (Methadone). Resident 1 was not prescribed methadone or any other opioid medication. This failure resulted in Resident 1 requiring emergency transfer to the acute care hospital, being intubated (is the placement of a flexible plastic tube into the trachea to maintain an open airway), being treated with Narcan (for the complete or partial reversal of opioid depression) and hospitalized for five days.
On 1/29/19, the Department received a complaint alleging Resident 1 had been hospitalized due to an overdose of a narcotic medication (Methadone) (opioid pain medication).
During an interview on 1/30/19 at 3:30 p.m., Complainant A stated she had received the complaint from Complainant B. Complainant A stated Resident 1, Complainant B's mother, had been hospitalized due to being found unresponsive in the facility on 1/22/19. Complainant A stated the acute care hospital had determined, by performing tests, that Resident 1 suffered from an overdose of narcotic medication. Complainant A stated Resident 1 had not been prescribed the narcotic medication. Complainant A stated Resident 1 had been hospitalized for six days in the acute care hospital.
During an interview on 2/1/19 at 10:13 a.m., Complainant B stated he was notified by the acute care hospital on 1/22/19 around 4 p.m., that his mother had been, "rushed," to the hospital. Complainant B stated he had not been notified by the facility. Complainant B stated he was told by the acute care physician his mother was found unresponsive and was not breathing on her own. The physician informed him hospital tests were done, confirming his mother was positive for Methadone (strong opioid medication used to treat pain). Complainant B stated his mother was not prescribed Methadone.
On 2/1/19, the Department received a Facility-Reported Incident and a facility document titled, "Investigation Summary," dated 2/1/19. The document revealed the date of the incident as 1/22/19, and the date of investigation initiated as 1/28/19. The document revealed, "[Resident 1's Name] was transferred to acute hospital due to low blood pressure, low oxygen saturation, unresponsiveness and tested positive for Methadone." The document revealed, "Conclusion: ...Resident is taking Trintellix (Vortiloxetine) which can cause false-positive UDS (Urine Drug Screen) results..."
A facility document titled, "Face Sheet," dated 2/4/19, revealed Resident 1 was admitted to the facility 7/8/14, and readmitted on 1/27/19. Resident 1's diagnosis included Dementia, Aphasia (loss of ability to express speech) following cerebral infarction (stroke), and Diabetes.
During an observation and interview on 2/5/19, starting at 10:55 a.m., Resident 1 was in her bed, and Complainant B was visiting. Resident 1 did not remember being hospitalized. Complainant B stated Resident 1's sudden hospitalization had been very frightening and upsetting, and he did not understand why his mother had Methadone in her body when it was not prescribed. Complainant B stated no one from the facility notified him when she had been taken to the hospital by ambulance.
During an interview on 2/5/19, starting at 12:55 p.m., Licensed Staff C stated he worked on 1/22/19, a.m. shift when Resident 1 was sent to the hospital. Licensed Staff C stated Resident 1's blood pressure was low (70/40) (normal blood pressure 120/80) in the morning, and her level of consciousness was decreased. Resident 1's physician ordered fluids and oxygen. Resident 1 first responded to the interventions, but then her respirations decreased from 12 or 13 down to 10 (normal range = 12-20/minute), and she had become non-responsive. The physician ordered to have her sent to the Emergency Room. Licensed Staff C stated he had called, but not left a message, for Resident 1's Responsible Party (Complainant B). Licensed Staff C stated he should have left a message. Licensed Staff C stated he found out about the Methadone in Resident 1 and, "it broke my heart." Licensed Staff C stated, "How did this happen?" Licensed Staff C stated there were residents in the facility who were prescribed Methadone. Licensed Staff C stated a resident in a room two doors from Resident 1, received high doses of Methadone, three times per day.
During an interview on 2/5/19 at 1:05 p.m., Unlicensed Staff D stated, on 1/22/19 around 7:30 a.m., she brought Resident 1 her breakfast. Resident 1 had a, "hard time to open her eyes." Unlicensed Staff D stated Resident 1 had not been like she normally was. Resident 1 tried to speak but was unable to pronounce her words. Resident 1 had, "not been the same."
A facility document titled, "Physician Orders," dated, "for the month January 2019," revealed no prescription for Methadone. The document revealed Resident 1 was prescribed Trintellix, since 3/1/17. No indications of adverse effects were documented.
A document titled, "SBAR (Situation, Background, Appearance, Review) Communication form," dated 1/22/19, revealed, "Upon assessment resident was not responding to sternal rub (a sternum rub is the application of painful stimulus with the knuckles of closed fist to the center chest of a patient who is not alert and does not respond to verbal stimuli).... Noted c([with) () (decreased) BP (blood pressure) of 76/40 and O2 (oxygen) 70% (normal rate is 95-100%) on RA (Room air) ... 911...called."
A document titled, "Licensed Nurse Progress Note," dated 1/22/19, revealed, "7:45 a.m. resident noted c (with) decreased level of conscious (sic)(consciousness).... BP 74/52, P 96, O2 sat 79%, ...R14....11:15 Resident non-responsive to sternal rub... BP still trending downward despite fluid hydration. 911 was called...before 911 arrived: BP 76/40 respirations decreased @ (at) 10/min. (minute) (normal respiration rate for adult at rest is 12-20 breaths/min)."
An acute care document titled, "ED (Emergency Department) Notes," dated 1/22/19 at 1315 (1:15 p.m.), revealed, "The patient was brought in by [FD Name] (Fire Department) Code 3 (lights, sirens, speed). She arrived on BiPAP (Bilevel Positive Airway Pressure). She is minimally responsive. She is hypotensive (low blood pressure). Weak respiratory effort... 1332 (1:32 p.m.) patient requires RSI (rapid sequence intubation) ...1434 (2:34 p.m.) With portable vent...Remains unresponsive to verbal or tactile Stimuli (sic)." The document revealed, "She is now obtunded and unresponsive..." The section, "Physical Exam," dated 1/22/19 1315 (1:15 p.m.) revealed: "BP (blood pressure) (!)76/31," (normal blood pressure is 120/80). The document revealed, "Neuro-- no obvious response to painful stimuli, GCS," (Glasgow Coma Scale) (The GCS is scored between 3 and 15, 3 being the worst and 15 the best. It is composed of three parameters: Best Eye Response, Best Verbal Response, Best Motor Response), "3."
An acute care document titled, "Drugs of Abuse Screen, 8, Urine, Random," dated 1/22/19 1535 (3:35 p.m.), revealed, "Methadone, urine, pos (positive)." The document revealed, "Reference Range: neg (negative)."
An acute care document titled, "Hospitalist Progress Notes," dated 1/26/19 0944 (9:44 a.m.), revealed, "She really perked up after we started Narcan infusion, so I suspect this is Methadone wearing off..." The document revealed, "suspected aspiration pneumonitis in the setting of Methadone. Spoke with [Physician Name] at SNF, she is not on Methadone there...Medically as methadone is clearing out of her system, she is waking up...."
An acute care document titled, "Hospitalist Discharge Summary," dated 1/27/19 1144 (11:44 a.m.), revealed, "...After intubation (is the placement of a flexible plastic tube into the trachea to maintain an open airway) there was lots of secretions that required aggressive suction but clear CXR (Chest X-ray) without obvious pneumonia...given positive methadone on UDS (Urine Drug Screen) and prolonged central apnea (no breathing) that lasted 3.5 days, that this was consistent with Methadone induced respiratory depression. She was temporarily given Narcan (a medication) (used to treat narcotic overdose in an emergency situation) with some improvement, but mostly improved with time..." The document revealed, " ...shock and AMS (Altered Mental Status) and respiratory failure were primary due to over-sedation." The document revealed, "...resume Vortiloxetine (Trintellix)..."
During an interview on 2/6/19 starting at 8:40 a.m., with Takeda Pharmaceuticals, the manufacturer of Trintellix, Representative X stated the company had no indications about Trintellix causing false-positive Methadone drug tests.
During an interview on 3/19/19 starting at 12:15 p.m., Management Staff E stated Resident 1 was transferred to the acute care hospital on 1/22/19, because of low blood pressure, low O2, and becoming unresponsive. Management Staff E stated the facility had been informed about Resident 1 testing positive for Methadone. Management Staff E stated Resident 1 had not been prescribed Methadone. Management Staff E stated the facility had residents who were prescribed Methadone, and one resident, who was prescribed high doses of Methadone, was in a room close to Resident 1. Management Staff E stated the facility investigated and determined Resident 1's positive Methadone test resulted from a false-positive test of her antidepressant medication, Trintellix. Management Staff E was asked about the reference the facility consulted to come to this conclusion. Management Staff E provided an abstract article (www.medscape.com/viewarticle/726897), which revealed, "A total of 25 reports of false-positive UDS results were identified. Categories of medications included antihistamines, antidepressants, antibiotics, analgesics, antipsychotics, and nonprescription agents." The article did not mention, Trintellix. Management Staff E confirmed Resident 1 was readmitted to the facility and remained on Trintellix.
During an interview on 1/14/20 at 12:23 p.m., Physician A, who was Resident 1's attending physician, stated he had been very surprised when he heard about Resident 1 testing positive for Methadone in the acute care hospital. Physician A confirmed Resident 1 had not been prescribed Methadone. When asked how he would explain Resident 1 testing positive, Physician A stated the only thing he could think of was a, "medication error" that, "someone else's medications (had been) given to her." When asked if the positive Methadone test result could have been a side effect of Resident 1's medications, Physician A stated, "No." Physician A stated, "A medication error (was) most likely," and it was, "not reasonable" it was a medication side effect of Resident 1's prescribed medications.
Lexicomp online, a drug reference, updated 3/13/19, revealed the main signs of an opioid overdose, "Very sleepy or not able wake up úSlurred speech or not able to talk ú Not breathing or breathing is very slow."
The above violation presented either imminent danger that death or serious harm would result or a substantial probability that death or serious physical harm would result.