DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED
101508 A. BUILDING __________
B. WING ______________
09/08/2020
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP
SUNCOAST HOSPICE 5771 ROOSEVELT BOULEVARD, CLEARWATER, FL, 33760
For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency.
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY SHOULD BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
L0511      
33893 Based on interviews, record reviews and policy review the agency failed to report the incident to appropriate authorities regarding the allegation of potential harm caused by medications left unsupervised and resulted in an over dose of opioids for 1(#1) patient out of 2 sampled. Findings included: An interview was conducted on 9/08/2020 at 10:00 a.m., with the Hospice Vice President (VP) of Organizational Excellence and Compliance who said, "I received a call from a regulatory investigator about a week ago asking questions about two of our hospice patients living at the (name of facility) assisted living facility (ALF). The regulatory agency received a call alleging that one of our hospice patients Patient #1 who resides in the ALF had somehow gotten into some pain medication that was for another patient we had at the ALF, Patient #2. Our nurse Staff G, RN was assigned a PRN evening weekend visit on 8/25/2020 to go to the ALF to see Patient #2. Patient #2 had a new order for pain medications that had been delivered to the ALF. We were told by the ALF that her breathing had changed (actively dying) and they wanted a nurse to come out and administer her Lorazepam and her pain meds if needed. The Director of Nursing (DON) at the ALF said the meds were due at midnight. We were called the next day, on 8/26/2020 and told that Patient #1 had been sent to the hospital stating that Patient #1 was awake acting as if he was blind, with altered mental status (AMS) and they were not aware of when the onset of Patient #1's symptoms were. We got report that Patient #1 was in the hospital, but that he had returned to the ALF and was back at his baseline. I told the ALF staff that a hospice nurse had not been out to see Patient #1 in over a week. We sent our nurse to the ALF on 8/25/2020 because there was not a nurse working at the ALF at the time Patient #2's meds were due. Med Techs cannot give narcotics. The med tech provided Staff G, RN Hospice Nurse with the keys to get into the med cart to get the meds. The ALF administrator wanted us (hospice) to interview our nurses to see what happened and what we knew about the event. I felt it was the ALF's responsibility to ensure medications were locked up. The box would have come from the pharmacy labeled with the patient's information on the outside of the box but there would not have been a label on the medication bottle inside the box." A review of the nursing note completed on 8/25/2020 at 10:45 p.m., by Staff G, RN Hospice nurse revealed, "RN focus visit made to administer the 11:30 p.m., meds; morphine and lorazepam. Both daughters were at the bedside. Upon entry, patient was in a semi-fowler's position, panting breaths and periods of apnea noted. Patient incontinent of B/B (bowel and bladder), and unresponsive; not able to fully close eyes. Daughters were calm and teary and had no questions for me. This nurse offered support and offered Chaplain care. Daughters are aware to call Hospice for any COC (change in condition), needs or concerns. "Documented under Collaboration Note: "Collaborated with triage nurse Director of Nursing-ALF. Family at bedside and med tech on duty." E-signed by Staff G, RN on 8/26/2020 at 12:59 a.m." The nurses note does not document a in or out time of her visit to the ALF. Furthermore, the nurses note does not document what meds were given or if any personal care was provided. The note does not document who Staff G, RN received the meds from or who she returned the meds to upon completion of her visit. The facility patient information sheet for Patient #2 reflected the Primary Diagnosis of: Hypertensive heart disease with heart failure, COPD. A review of the medical record reflected on 8/25/2020 the plan of care was updated and reviewed for a Change in Level of Care and updated to reflect: Oxygen Orders: 02 2 LPM NC PRN. New Medications: Start on 8/25/2020 new medication: Insert 1 mg of acetaminophen suppository (650 mg suppository) rectally every 4 hours as needed. Medication Reason: Fever, pain (fever pain, headache). Start on 8/25/2020 New Medication: Take 1 mg of Lorazepam concentrate (2mg/ml concentrate) by mouth every 6 hours as needed. Medication Reason: Pain, dyspnea. All ordered PO and inhalation meds and creams were discontinued on 8/25/2020. A review of the medical record for Patient #1 revealed there was not an order for any opioid pain medication. A review of the medication administration record for Patient #1 revealed no order for morphine or liquid Roxinol. A review of the nurse's notes reflected that Patient #1 had not received a hospice nurse visit on 8/25/2020. The VP of Hospice said, "Patient #1 has not had a nurse visit in the last week." A review of the hospital record documented Patient #1 was seen in the emergency room on 8/26/2020 after being brought in by EMS who reported that when they arrived to transport the Patient to the hospital they noted a bottle of morphine at his bedside with the name of another Patient on it. A review of the laboratory results dated 8/26/2020 the drug screen documented for opioids <300 nano grams. An interview was conducted on 9/08/2020 at 10:02 a.m., the family member for Patient #1 said, "I got a call from the ALF on the morning of 8/26/2020 at around 8:30 a.m., Staff A, ALF staff called to tell me that Patient#1 was saying he could not see, he was blind, was very confused and would not respond to direction. I was told that the ALF aide on that day had gone in his room on morning rounds and Patient #1 was still asleep. Patient #1 always gets up for breakfast. When they tried to wake him that is when he said he could not see and became agitated. I thought maybe he had a stroke and since his eyesight had been affected, I told them to go ahead and call 911. At 8:48 a.m., I called hospice and asked to speak to Staff B, RN the nurse assigned to Patient #1. I spoke to Staff C and was told that Staff B, RN was not in the office and she would have her call me. I never did get a call back from Staff B, RN. At 9:47 a.m., I called the ALF back and they told me that Patient #1 had already been picked up by EMS and was on the way to the hospital. At 10:18 a.m., I talked to Staff D, Hospital Employee who told me Patient #1 had been there for about 30 minutes. The nurse at the hospital was the one that told me when the paramedics brought Patient #1 in that there had been a small bottle of morphine found at his bedside with another patient's name on it. They gave him a little Narcan in the emergency room and that woke him up for a while. Staff D, Hospital Staff told me she had called this into a regulatory agency and reported the incident. No one at the ALF told me anything about the medication that was found at his bedside. Later that day I spoke to Staff E, ALF Employee who told me that Patient #1 had been dosed with morphine. Yes, I was told that the Paramedics pointed out the medication was by the bed. I was told that Staff F, RN Hospice nurse was there when Patient #1 was transferred to the hospital. I never got a call from hospice from anyone about the incident. On 8/31/2020 Staff F, RN Hospice Manager did call me to check on Patient #1. She apologized for what had happened. I asked Staff F, RN Hospice Manager what had happened, and she told me that hospice was investigating it but added she did not believe the ALF staff were responsible for the medication error. Later that week, I spoke to the Executive Director of the ALF who said that she had been trying to get the name of the nurse that had come to the ALF the night of 8/25/2020 to administer the medications to Patient #2 because no one at the ALF recognized her. The Executive Director (ED,) said that she was told by hospice that they could not provide the ED with the nurse's name and that they were still investigating it. I was told that Staff G, RN Hospice Nurse arrived at the ALF and she appeared a little confused so Staff H, Medical Technician ALF opened her medication cart and gave Staff G the bag of medications for Patient #2. When Staff G, RN was done she left the medications on the top of the med cart because that is "what she was told to do" by Staff H, Med Technician. Then around 12:15-12:30 Staff F, Med Technician ALF found the medications on the top of the medication cart and then locked them up in the cart. Also, I saw the bottle of morphine and it was very unusual the way that it had been opened. The top foil had been punctured and like a stopper had been put in it to be able to use a syringe to draw out the medication. But the stopper had failed to push through the protective foil completely. When the bottle was found by Patient #1's bed there was no stopper in it. The bottle was open but did not have cap or stopper on it. The ALF staff told me that there was a bag of syringes in the hospice bag and when the ALF staff started their investigation, they checked what was in the bag and that the bag of syringes had not been opened." A telephone interview was conducted at 11:04 a.m., on 9/08/2020 with Staff J, Pearl Team said, "We had a Patient #2 who needed some medications administered late on the evening of 8/25/2020- needed some morphine-Staff K, Manager Pearl Team and I were told by Staff G, RN Hospice Nurse that she had to call a staff member in the ALF to come back and get the meds and then that person locked them up in the med cart at the ALF. The next morning Staff F, RN Hospice got a call from the ALF that Patient #1 was acting differently- and asked her to make a visit- but the daughter of Patient #1 called 911 before hospice could arrive. I understand Patient #1 is back at the ALF and back at his base line. I spoke to the DON and she told me they did not have an employee by the name of Staff L who Staff G, RN said was the med tech who she gave Patient #2's meds to when she was done and that she walked her out. When I asked Staff G who was the person, she returned the meds to and said she saw her lock them up and Staff G, RN continually said it was Staff L but then Staff G did add that no one had on name badges that night and she may have not gotten the right name. My Expectation is that our nurse would fill out the medication administration record (MAR) at the ALF and complete it- Yes, the nurses need to, they do have to they do reconcile the MAR. So, we can keep track of how much was left." An interview was conducted on 9/08/2020 at 10:33 a.m., The DON at the ALF said, "The ALF administrator had been the one who called in the report to the state agency. Patient #1 and Patient #2 their rooms were directly across the hall from each other. We called hospice because Patient #2 had meds due that night (8/25/2020) and we would not have a nurse in the building at that time and our Med Techs cannot administer those medications. The nurse from hospice, Staff G, RN came in at 11:15 p.m., to make a visit to Patient #2. When the hospice nurse came in Staff H, Med Tech had the keys to the medication cart and her shift ended around 11:00 p.m. When Staff H got in the parking lot, she saw a car pulling in and it was Staff G, RN hospice nurse. Staff H said she walked back into the building and let Staff G in and onto the locked memory care unit. Then Staff H unlocked the medication cart and handed Staff G, RN Patient #2's medications. Staff H then left. Staff F, Med Tech for the ALF came in around 12:15 p.m. At 12:15 p.m., Staff F went looking for Staff G, to make sure she had been there and given Patient #2 her meds. At 1215 p.m., Staff F saw the meds for Patient #2 sitting on top of the med cart and she locked them up. No one realized that the bottle of Roxinol for Patient #2 was not in the bag. When ALF staff went in to check on Patient #1, he was not acting himself. We called 911. Actually, the paramedic found the box of Roxinol at Patient #1's bedside that was for Patient #2. We notified the physician and hospice that we were sending Patient #1 to the hospital. When the hospice nurse came into administer Patient #2's meds her daughters were here siting at her bedside. One of the daughters said that Staff G, RN came in around 11:00 p.m., went into the bathroom, turned the light on and a few minutes later came out with some syringes. That would not have been unusual for the nurse to go into the bathroom rather than to come into the room and turn on the bright lights with the family there and the patient dying. We interviewed all of the staff that were here, and they all said that the hospice nurse said that she left a bag over there (pointing towards the med cart) and could someone let her out because she was ready to go home. The only one around at that time was Staff I, Aide who was cleaning the floor. When we talked to hospice, they said that Staff G, RN told them that Staff L was the person she gave Patient #2's meds to and that Staff L walked her out. We do not have an employee by the name of Staff L. We have cameras that show who comes in and goes out of the building and also who goes in and out of the memory care unit. When we reviewed the tape, we could see Staff I, aide walking Staff G, RN out. Then we can see that Staff F, Med Tech arrived at 12:15 p.m. We only have the one entrance. I spoke to the supervisor at hospice and told her that we do not have a staff by the name of Staff L. The medication box the paramedics found at the bedside of Patient #1 looked like it had not been opened correctly. No, the aides do not have a key to get into the med carts. I can tell you exactly what time the hospice nurse got here- we have cameras and I looked at the footage and found: At 11:14 p.m., the DON identified 2 people entering as Staff H, Med Tech and Staff G, RN Hospice nurse entered the memory care unit. At 11:16 p.m., Staff H, Med Tech left the building At 11:24 p.m., the DON said Staff I ALF Aide and Staff G, RN Hospice Nurse left the memory care unit, Staff I, ALF Aide with a broom, The Hospice nurse was not carrying anything." An interview was conducted on 9/08/2020 at 11:17 a.m., with the Care Team Manager for the Pearl Team who works the evenings and weekends- "I was told by Staff G, RN Hospice Nurse that she received the meds and it was a full bottle (Roxinol)- Staff G told me that she did ask for a medication administration record (MAR) twice and was told by the ALF staff that they did not have a MAR- after she administered the meds she had to call for the med tech who was leaving to let her out and she saw her lock them up. My understanding was the med tech who locked up the meds was the person who walked her out. The nurse manager of the pearl team called me to say that the ALF had called and stated there was a concern about the meds for Patient #2. They did say that they had found medications in Patient #1's room and asked me to talk with Staff G, RN Hospice Nurse asked to see what happened. I spoke to Staff G and she told me what I just said to you. She did say that it was a brand- new bottle of Roxinol. That it had never been open." A telephone interview was conducted on 9/08/2020 at 12:13 p.m., with Staff G, RN Hospice Nurse who said she had been an RN for 19 years, and had worked for hospice about a year and a half. "I already spoke to someone last week ... "About 11:00 p.m., I go to the call that I had been assigned to go out and administer medications to Patient #2. I got there at 11:30 p.m., they let me in the door, the med tech, took me to the med cart, the med tech gave me the meds, and walked me back to patient's room (through memory care). I gave the medications as ordered, I gave lorazepam and morphine. I don't remember the orders; I would have to look at the chart. Staff H, Med Tech told me she had to go- I had to call and the other girl who was cleaning the floor (already identified as Staff I, ALF Aide she took the meds from me- I asked if there was a MAR and she told me no-she told me to go- I told her to walk me out because I needed her to punch the code to the key pad so I could get out. I saw her lock the meds in the cart and she walked me out. I believe she was a med tech-I believe her name was Staff L. No one around here had on a name badge." Staff G, RN Hospice Nurse became very loud and agitated on the phone and said "I left at 11:50 pm." An interview was conducted on 9/08/2020 at 1:52 p.m., the Hospice VP, Organizational Excellence and Compliance said, "I did not feel it had anything to do with us because the ALF should have been the one to ensure that the medications were stored properly. No, I did not complete any reports or fill out a grievance. No, I did not investigate it either. In hindsight I guess I should have." The VP of hospice confirmed by saying, "Yes, I would agree this would be considered a Sentinel Event by our policy and we should have followed our policy. A telephone interview was conducted on 9/08/202 at 2:27 p.m., with the Medical Director for the hospice agency who said, "Absolutely the medications definitely should have been locked up. The hospice nurse should have made sure before she left that they were locked up." A review of the agency policy and procedure titled Sentinel and Adverse Events with an effective date of 9/24/2018 and no revision date documented, "Policy: (Name of agency) will respond to serious safety and/or adverse events utilizing a systematic program. The program is designed to discover the root cause of the event, analyze the cause, develop and implement corrective actions, provide relevant education and assure corrective practice integration into programs and operations. Additionally, the program will seek to support staff and decrease the potential negative impact to employees through a formalized staff debriefing process. Definitions: Events that impact the safety of patient's, caregivers, staff, volunteers, and affiliated community members re to be considered relevant to this policy. 2. Sentinel or Serious Events: A sentinel event is the unexpected occurrence involving death, permanent harm or severs temporary harm. An event that occurred that may have contributed to or resulted in permanent. Examples include serious patient falls, treatment errors. An event occurred that required intervention to sustain life. Examples include medication error, physical violence...Procedures: All events will result in Incident Reporting .The Risk Manager in consultation with the appropriate Director will determine a course of action based on the severity of the event. Patients will be notified of sentinel events that impact care. c. Sentinel events will automatically result in Root Cause Analysis and Staff Debriefing. 2. Debriefings will be held as soon as is feasible following the event...4. The Risk Manager will ensure all reportable events are reported to the appropriate regulatory agencies within the required timeframe. all voluntary reports to accrediting agencies and other interested parties will be made at the discretion of the Risk Manager." A review of the agency policy titled Medication Management-Adverse Drug Events with an effective date of 11/03/2017 and no documentation of a revision date documents, "Policy: (Name of the agency) will assure that staff responds appropriately to actual or potential adverse drug events and medication errors, and that serious adverse events are reported and investigated to improve patient safety..." A review of the agency policy titled Safe and Effective Administration of Medications with an effective date of 1/05/2018 "Purpose: To provide guidelines for the safe administration of medications by licensed personnel. C. Once medication is administered by licensed personnel, the Nurse will: a. Review and document medications taken/administered (and symptom management results as applicable). A review of the agency job description for Staff RN (Registered Nurse) with an effective date of 5/2014 #4, "Promotes a culture of safety by implementing policy, guidelines, applying best practice, safety assessment and management principles. Applies critical thinking, judgement and ethical principles for problem solving in all patient and caregiver critical situations. 7. Documentation is complaint with all organizational standards including productivity, timeliness and adheres to relevant policies and practice guidelines. 14. Demonstrates the ability to administer, monitor and document medications as prescribed by attending physician. ..."