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
261671 A. BUILDING __________
B. WING ______________
03/12/2020
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP
BREEZE HOSPICE OF MISSOURI, LLC 301 SOVEREIGN CT, STE 209, BALLWIN, MO, 63011
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)
L0544      
17006 Based on policy review, record review and interview the agency failed to provide/document ongoing education regarding medications in one (Record/Patient #1) of three records reviewed. Findings included: Review of the agency policy titled, "Safe/Effective Use of Medications," dated December, 2018, showed: - The purpose is to provide guidelines for the instruction of patients and family/caregivers regarding the safe, effective use of medication; - To promote correct administration of medication by patients and family/caregivers; - The patients and family/caregivers will receive information regarding the safe and effective use of medication, in accordance with applicable hospice policies; - The hospice will encourage patient and family/caregiver participation in his/her own hospice care and will explain the correct administration of medications by the patient or family/caregiver, as ordered by the attending physician or other authorized licensed independent practitioner or purchased over the counter. Teaching will also include the safe storage of medications; - As part of the comprehensive assessment, the patient and family/caregiver will be assessed as to their knowledge and skill required for safe and effective use of medication; - Based on the assessment, the clinician will review written hospice information available for the patient and family/caregiver instruction; - Using the written information, the clinician will review the key points required, based on patient knowledge and skills, as well as identified. This may include: - Teaching the patient the purpose and side effects of medication, and the patient's role in identifying and preventing medication errors; - Assisting the patient in setting up medications for the first time; - Assessing the patient's ability to self-administer medications correctly, and document the patient's response and comprehension; - Instructing the patient and family/caregiver regarding safe storage of medications; - The nurse will plan with the patient and family/caregiver for the safe, therapeutic storage of drugs during the assessment process; and - Documentation of patient and family/caregiver instruction in the clinical record will include information taught, patient and family/caregiver understanding, return demonstrations, response to teaching, and updating the medication profile. RECORD/PATIENT #1: Review of the skilled nurse (SN) initial assessment dated 01/22/2020 showed: - Diagnosis of cerebral atherosclerosis (a build-up of plaque in the blood vessels of the brain); - The patient had a primary healthcare representative; - The patient lived with a family member (did not identify what family member); - The patient was alert and oriented times one to two (did not include whether this was person, place, or time) and had confusion; - The patient used a walker with stand by assistance; and - The patient had no active medications. Review of a form titled, "Prior Authorization Statement" showed the start date for hospice services to begin was 01/22/2020 and was signed by the patient's power of attorney and checked the box that he/she was the Activated POAHC (Power of attorney for healthcare, allows a selected representative to make healthcare decisions for you). Review of the SN visit note dated 01/23/2020 showed: - Licensed Practical Nurse (LPN) A educated the caregiver about the use of a comfort pack (a supply of medications kept in the home so they will be available to rapidly treat symptoms that may occur) in the home; - The caregiver requested a comfort pack. The caregiver was aware not to open the comfort pack until he/she contacted the hospice nurse when it was needed. The comfort pack will be ordered for the patient. The nurse informed the caregiver, he/she should receive it no later than the following week; and - No documentation of whether the caregiver was the patient's power of attorney or whether the power of attorney was contacted and provided education regarding a comfort pack for the home. Review of a physician order dated 02/05/2020 showed: - An order for morphine sulfate (Roxanol, narcotic pain medication) oral solution 100 milligrams (mg)/5 milliliters (ml). Take 0.25 ml (5 mg) by mouth or under the tongue every three hours as needed for shortness of breath or pain; and - An order for a comfort pack (no morphine). Review of the clinical record showed no documentation that the power of attorney was contacted and provided education regarding the physician order for morphine and a comfort pack. Review of the SN visit note dated 02/13/2020 showed LPN A documented: - The patient lived with a 24/7 caregiver that alternated with another caregiver; - The patient is not on any routine medications; - The comfort pack was now in the home; - The medications listed under the medication section showed: * Roxanol (narcotic pain medication) 5 mg every three hours orally as needed (0.25 ml of 20 mg/ml). Take 0.25 ml every three hours as needed for pain or dyspnea (breathing difficulty); * Acetaminophen (Tylenol) 650 mg every four hours rectally (one suppository) per rectum every four hours for pain or fever; * Lorazepam intensol (anti-anxiety medication) 0.5 mg. Take 0.25 ml PO/SL every four hours as needed for anxiety/terminal restlessness (The pharmacy list showed they dispensed tablets instead of a liquid form); * Levsin 0.125 mg one tablet PO/SL every six hours as needed for increased secretions; and * Zofran 4 mg by mouth every six hours as needed for nausea (This was not included on the list of medications the pharmacy dispensed); * Prochlorperazine 10 mg tablet was not included on this list on the SN note but was included on the pharmacy list as being dispensed on 02/05/2020; and - No documentation of further education to the caregivers and/or power of attorney regarding the medications in the comfort pack or roxanol. Review of the SN notes dated 02/21/2020, 02/24/2020, and 02/25/2020 showed LPN A documented the patient did not have pain, anxiety or nausea and vomiting. The comfort pack was now in the home. The caregiver was aware to call the hospice with any concerns, needs or issues. Review of the SN (this nurse no longer worked at the agency) visit note dated 03/05/2020 showed: -The hospice received a call from the power of attorney that Roxanol was in the house and opened, and they didn't know who opened the Roxanol or how much was used; -They suspected one of the caregivers may have diverted some of the Roxanol and that the patient was restless; - When the nurse arrived the patient lay in bed with his/her eyes closed; -The patient was somewhat restless and lifting his/her legs in the air; - The nurse examined the Roxanol bottle; - The bottle was not sealed and appeared to have 30 mls in the bottle; - The nurse spoke to the caregiver that was present and spoke to the power of attorney on the phone; - The caregiver suggested that the other caregiver may have put mouthwash in the bottle and diverted the morphine; - The nurse explained that he/she could not tell if it was morphine as he/she was not a pharmacist, but the bottle had 30 mls in it and had been opened; - As the patient was restless, the nurse administered 0.5 ml (10 mg) of Roxanol per the physician (medical director), now; - The patient calmed down and was resting although he/she kept his/her legs elevated in the air; - The nurse delivered a medication administration record and lock box and explained their use; - The power of attorney wanted another bottle of Roxanol delivered as he/she was unsure if the current bottle had been tampered with; - The nurse resealed the bottle with a sticker and educated the caregiver and power of attorney to keep record of every dose and to count the medication after every dose; - The nurse provided medication instruction in great detail; and - The nurse requested they notify the hospice of any concerns or issues. Review of the SN note dated 03/06/2020 showed LPN A documented: - The patient resided in an independent community apartment complex with a 24/7 caregiver that alternated with another caregiver; - The patient is transitioning, staring out and through, speech is garbled, extremities cool and flaccid (limp), unable to eat or drink, no pain, no signs of anxiety, nausea, or dyspnea; - The nurse notified the family of the change in condition; and - No documentation of any further education provided regarding the medications or whether any further medication had been administered since the previous evening. During an interview on 03/11/2020 at 9:10 AM, the administrator (who is also a physician) stated: - The power of attorney had hired two caregivers to care for the patient. One of which was a cousin of the power of attorney, and the other was from an agency; - The nurses taught both caregivers how to give medications; - He/she would expect the nurse to document the instructions they gave; and - LPN A told the administrator he/she instructed both caregivers step by step on how to give the medications. During an interview on 03/11/2020 at 10:27 AM, with Registered Nurse (RN) B and the administrator, RN B stated: - He/she had only seen the patient a couple of times; - Before they order a comfort pack, they discuss it with the patient, caregiver and power of attorney; and - When the comfort pack arrived, they teach how to give the medications, side effects, and how to store the medication. During an interview on 03/11/2020 at 2:30 PM, LPN A stated: - The caregiver that was also a family member requested the pain medication and comfort pack; - He/she explained what was in it, and there would be instructions to not open it without calling a nurse and to keep it in the back of the refrigerator so he/she would not have to look for it; -The patient went into respite so the comfort pack was put on hold; -On 02/13/2020 he/she told the caregivers not to open the comfort pack until they call the nurse; - He/she was not sure he/she documented talking to the other caregiver about the comfort pack; - He/she was not sure he/she talked to the power of attorney about ordering the comfort pack and Roxanol because he/she thought the caregiver in the home was the power of attorney; - If he/she knew that was not the power of attorney, he/she would have absolutely discussed it with them; - He/she received a call while on call from one of the caregivers but was unsure of the date and time. The patient was restless and grimacing. He/she instructed the caregiver over the phone how to give the Roxanol and if it did not work, he/she would make a visit (There is no documentation regarding this call); - He/she went to visit the following day and the caregiver did not have to use the Roxanol. The caregiver said he/she played some music and the patient had a bowel movement and calmed down; - On another occasion, LPN A received a message from the office to call the other caregiver who was a family member to instruct on how to give medication. The caregiver said the patient was having some pain, restless and grimacing. LPN A instructed the caregiver on how to give the Roxanol. The caregiver said the tape was broken on the comfort pack but did not say the Roxanol had been opened. He/she had the caregiver look at the Roxanol bottle because he/she wanted the caregiver to know how much was in the bottle before he/she gave any of the medication. The caregiver said there were 30 mls in it and it was a blue color; and - He/she did not document this on a note because it was not a visit. The agency did not have on call notes, just a prn (as needed) visit note. During an interview on 03/11/2020 at 3:15 PM, the administrator stated: - He/she did not know if they had a specific policy on placing a comfort pack in the home; - Everyone is supposed to document a case communication note any time they have contact with a patient, caregiver, or family; and - He/she would expect the nurse to discuss any medications with the power of attorney before ordering medications. During an interview on 03/11/2020 at 4:35 PM, the administrator stated: -Just before 5:00 PM on 03/05/2020 he/she talked to their director of nursing (DON, who no longer worked at the agency) that the power of attorney had called; and -LPN A told him/her that she had walked the caregiver through giving the Roxanol (There was no documentation regarding this). During an interview on 03/12/2020 at approximately 12:00 (noon), LPN A stated: - He/she did not find documentation where he/she instructed both caregivers regarding the Roxanol and comfort pack; - On 01/23/2020, he/she instructed the caregiver that was a family member on giving the Roxanol and comfort pack medications; - The patient had more than two caregivers because he/she had seen other caregivers leaving the home as he/she was arriving but only interacted with two of the caregivers; - If a patient or family calls and they need to use something out of the comfort pack, he/she goes over what symptoms they are having and based on that decides what is needed and walk them through giving the medication over the phone; - He/she did not necessarily make a visit if it was the first time needing to give medications unless the symptoms were uncontrolled; - The first time one of the caregivers called was while he/she was on call, but he/she ended up not needing to give the Roxanol; - He/she thought she turned in a call log about this communication with the caregiver; - It was on 03/05/2020, he/she got a text message from the hospice office manager at 2:40 PM that the other caregiver called and he/she needed to call them to instruct on giving medications; - The caregiver opened the Roxanol, and the nurse instructed him/her step by step how to draw up and give the Roxanol; - The nurse assumed the caregiver gave the Roxanol and instructed the caregiver if it did not work in 15 to 30 minutes to call back, then at that point the DON was on call; - He/she did not document a note because it was not a visit; and - He/she had not been instructed to do case communication notes. During an interview on 03/12/2020 at 12:22 PM, the administrator stated: - When the patient gets a comfort pack, the instructions are to notify the nurse or physician before using; - The nurse should notify the physician if a medication has been started; - The nurse fills out a log if a patient calls while on call and should document a case communication note if they have contact about a patient during the day; and - He/she did not have the call logs for March, 2020 because the nurse that was on call no longer worked for the agency and had not turned in the log. Review of the on call logs provided by the administrator on 03/12/2020, at approximately 12:30 PM showed no documentation about the patient's caregiver calling and LPN A instructing how to give the Roxanol. The only call logged was on 02/04/2020, when the patient had a fall. During an interview on 03/12/2020, at 2:18 PM, with the office manager and administrator, the office manager showed on his/her phone where he/she sent a text to LPN A on 03/05/2020 to call the family to instruct them on giving medication. The administrator said LPN A should have documented a case communication note regarding the call.
L0549      
17006 Based on policy review, record review, observation, and interview, the agency failed to ensure an accurate plan of care/medication profile was maintained for each patient to include drugs and treatments necessary to meet the needs of the patient in two (Record/Patient #1 and #2) of three records reviewed. This deficient practice has the potential to affect the safe and effective medication administration for all patients served by the agency. Findings included: Review of the policy titled, "Medication Profile," dated December, 2018 showed: - The medication profiles will be updated for each change to reflect current medications, and new and/or discontinued medications; - A drug regimen review will be performed at the time of initial and comprehensive assessments, when updates to the comprehensive assessments are performed, when care is resumed after a patient has been placed on hold, and with the addition of a new medication; and - During subsequent home visits, the medication profile will be used as a care planning and teaching guide to ensure that the patient and family/caregiver, as well as other clinicians, understand the medication regimen. Review of the agency policy titled, "Safe/Effective Use of Medications," dated December, 2018, showed: - The purpose is to provide guidelines for the instruction of patients and family/caregivers regarding the safe, effective use of medication; - To promote correct administration of medication by patients and family/caregivers; - The patients and family/caregivers will receive information regarding the safe and effective use of medication, in accordance with applicable hospice policies; and - Documentation of patient and family/caregiver instruction in the clinical record will include information taught, patient and family/caregiver understanding, return demonstrations, response to teaching, and updating the medication profile. RECORD/PATIENT #1: Review of the skilled nurse (SN) initial assessment dated 01/22/2020 showed: - Diagnosis of cerebral atherosclerosis (a build-up of plaque in the blood vessels of the brain); - The patient had no active medications; and - The patient did not have pain but used Tylenol as needed for pain (this was not included on the medication profile or plan of care until 02/26/2020). Review of a physician order dated 02/05/2020 showed: - An order for morphine sulfate (Roxanol, narcotic pain medication) oral solution 100 milligrams (mg)/5 milliliters (ml). Take 0.25 ml (5 mg) by mouth or under the tongue every three hours as needed for shortness of breath or pain; and - An order for a comfort pack (a supply of medications kept in the home so they will be available to rapidly treat symptoms that may occur) with no morphine. Review of the pharmacy's comfort pack contents showed it included: - Acetaminophen 650 mg suppositories. Insert one suppository rectally every six hours as needed for mild pain or fever; - Haloperidol (anti-psychotic medication also used for nausea and vomiting) 2 mg/ml. Take 0.5 ml (1 mg) by mouth or under the tongue every six hours as needed for agitation or nausea and vomiting; - Hyoscyamine 0.125 mg sublingual tablets. Take one tablet under the tongue very four hours as needed for secretions; - Lorazepam 0.5 mg tablets. Take one tablet by mouth every six hours as needed for anxiety or agitation; - Prochlorperazine 10 mg tablets. Take one tablet by mouth every six hours as needed for nausea and vomiting; and - Bisacodyl 10 mg suppository. Insert one suppository rectally once daily as needed for constipation. Review of a pharmacy form (untitled) showed the following medications were dispensed on 02/05/2020: - Acetaminophen 650 mg suppositories. Insert one suppository rectally every six hours as needed for mild pain or fever; - Haloperidol (anti-psychotic medication) 2 mg/ml. Take 0.5 ml (1 mg) by mouth or under the tongue every six hours as needed for agitation; - Hyoscyamine 0.125 mg sublingual tablets. Take one tablet under the tongue every four hours as needed for secretions; - Lorazepam 0.5 mg tablets. Take one tablet by mouth every six hours as needed for anxiety or agitation; - Prochlorperazine 10 mg tablets. Take one tablet by mouth every six hours as needed for nausea and vomiting; and - Bisacodyl 10 mg suppository. Insert one suppository rectally once daily as needed for constipation; Review of another pharmacy form (untitled) showed an order dated 02/05/2020 for morphine concentrate 100 mg/5 ml (20 mg/ml). Take 0.25 ml (5 mg) by mouth or under the tongue every three hours as needed for shortness of breath or pain. Review of the SN visit note dated 02/13/2020, showed Licensed Practical Nurse (LPN) A documented the following: - The patient is not on any routine medications; - The comfort pack was now in the home; - The medications listed under the medication section showed the following discrepancies with the list of medications the pharmacy dispensed: * Lorazepam intensol (anti-anxiety medication) 0.5 mg. Take 0.25 ml by mouth or under the tongue every four hours as needed for anxiety/terminal restlessness (The pharmacy list showed they dispensed tablets instead of a liquid form); * Zofran 4 mg by mouth every six hours as needed for nausea (This was not included on the list of medications the pharmacy dispensed); * Prochlorperazine 10 mg tablet was not included on this list in the SN note but was included on the pharmacy list as being dispensed on 02/05/2020; * Haloperidol 2 mg/ml. Take 0.5 ml (1 mg) by mouth or under the tongue every six hours as needed for agitation was not included on the SN note but was included on the pharmacy list as being dispensed on 02/05/2020; Review of the care plan/interdisciplinary team meeting notes dated 02/14/2020 and 02/28/2020 showed: - Assess effectiveness of treatments and interventions and report changes or unfavorable responses to the physician; - Instruct on new and changed medications; - Assess the patient and family with drug administration and the risk of diversion; - The medications listed showed the following discrepancies with the list of medications the pharmacy dispensed: * Lorazepam intensol (anti-anxiety medication) 0.5 mg. Take 0.25 ml PO/SL every four hours as needed for anxiety/terminal restlessness (The pharmacy list showed they dispensed tablets instead of a liquid form); * Haloperidol 2 mg/ml. Take 0.5 ml (1 mg) by mouth or under the tongue every six hours as needed for agitation was not included on the medication profile but was included on the pharmacy list as being dispensed on 02/05/2020; and * Zofran 4 mg by mouth every six hours as needed for nausea (This was not included on the list of medications the pharmacy dispensed); and * Prochlorperazine 10 mg tablet was not included on this list but was included on the pharmacy list as being dispensed on 02/05/2020. Review of the current medication profile showed the following discrepancies with the list of medications the pharmacy dispensed: - Lorazepam intensol 0.5 mg every four hours as needed. Take 0.25 ml by mouth or under the tongue every four hours as needed for anxiety/terminal restlessness with an effective date of 02/07/2020 (The pharmacy list showed they dispensed tablets instead of a liquid form); - Zofran 4 mg every six hours as needed for nausea with an effective date of 02/07/2020 (This was not included on the pharmacy list as being dispensed on 02/05/2020); - Haloperidol 2 mg/ml. Take 0.5 ml (1 mg) by mouth or under the tongue every six hours as needed for agitation was not included on the medication profile but was included on the pharmacy list as being dispensed on 02/05/2020; and - Prochlorperazine 10 mg tablet was not included on the medication profile but was included on the pharmacy list as being dispensed on 02/05/2020. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to hospice services on 02/28/2020 with a diagnosis of lung cancer. During a home visit observation on 03/11/2020, at 11:05 AM showed the following medication discrepancies: - The patient took desipramine (anti-depressant) 50 mg at bedtime. The caregiver said the patient had taken this for 25 years. This was not included on the agency's care plan or medication profile; - The patient took buspirone (anti-depressant) HCL 15 mg one tablet twice a day. This was not included on the agency's medication profile and care plan; - The patient took chlorpromazine (thorazine, anti-psychotic) 200 mg, three tablets at bedtime. The agency's medication profile and care plan showed 200 mg one tablet at bedtime; - The medication profile and care plan showed an order for ativan (Lorazepam, anti-anxiety) 0.5 mg every four hours as needed. The medication label showed Lorazepam 0.5 mg every six hours as needed for anxiety/agitation; - The following medication included in the comfort pack were not included on the medication profile or care plan: * Morphine solution 100 mg/5 ml (20 mg/ml). Take 0.25 ml every four hours as needed for pain or shortness of breath; * Halo 2 mg/ml. Take 0.5 ml (1 mg) by mouth or under the tongue every six hours as needed for agitation; * Prochlorperazine 10 mg one every six hours as needed for nausea and vomiting; * Levsin 0.125 mg one tablet under the tongue every four hours as needed for secretions; * Bisacodyl 10 mg suppository, insert one suppository rectally daily as needed for constipation; and * Acetaminophen 650 mg one suppository rectally every six hours as needed for mild pain or fever. During an interview on 03/11/2020 at 11:45 AM, Registered Nurse (B) said when new or changed medications are entered into the computer system the medication profile is updated. Every two weeks at the interdisciplinary team meeting they review medications, and the medication profile is updated. The findings were reviewed with the administrator on 03/11/2020 at approximately 1:00 PM. No further information was provided.
L0591      
17006 Based on policy review, record review and interview the agency failed to ensure/document the patient's legal representative was contacted before placing new medications in the home, failed to ensure/document that all caregivers received adequate teaching and their ability evaluated regarding administration of medications, received adequate assessment of the risk for diversion of medications and adequately assess/document whether medications had been used after the caregiver expressed suspicion of diversion of medications in one (Record/Patient #1) of three records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency policy titled, "Safe/Effective Use of Medications," dated December, 2018, showed: - The purpose is to provide guidelines for the instruction of patients and family/caregivers regarding the safe, effective use of medication; - To promote correct administration of medication by patients and family/caregivers; - The patients and family/caregivers will receive information regarding the safe and effective use of medication, in accordance with applicable hospice policies; - The hospice will encourage patient and family/caregiver participation in his/her own hospice care and will explain the correct administration of medications by the patient or family/caregiver, as ordered by the attending physician or other authorized licensed independent practitioner or purchased over the counter. Teaching will also include the safe storage of medications; - As part of the comprehensive assessment, the patient and family/caregiver will be assessed as to their knowledge and skill required for safe and effective use of medication; - Based on the assessment, the clinician will review written hospice information available for the patient and family/caregiver instruction; - Using the written information, the clinician will review the key points required, based on patient knowledge and skills, as well as identified. This may include: - Teaching the patient the purpose and side effects of medication, and the patient's role in identifying and preventing medication errors; - Assisting the patient in setting up medications for the first time; - Assessing the patient's ability to self-administer medications correctly, and document the patient's response and comprehension; - Instructing the patient and family/caregiver regarding safe storage of medications; - The nurse will plan with the patient and family/caregiver for the safe, therapeutic storage of drugs during the assessment process; and - Documentation of patient and family/caregiver instruction in the clinical record will include information taught, patient and family/caregiver understanding, return demonstrations, response to teaching, and updating the medication profile. RECORD/PATIENT #1: Review of the skilled nurse (SN) initial assessment dated 01/22/2020 showed: - Diagnosis of cerebral atherosclerosis (a build-up of plaque in the blood vessels of the brain); - The patient had a primary healthcare representative; - The patient lived with a family member (did not identify what family member); - The patient was alert and oriented times one to two (did not include whether this was person, place, or time) and had confusion; - The patient used a walker with stand by assistance; - The patient had no active medications; - Under the care plan intervention for the nurse to assess the patient/family/caregiver and living environment for the risk of diversion the nurse noted the patient did not have narcotic medications; and - The patient did not have pain but used Tylenol as needed for pain (this was not included on the medication profile and plan of care). Review of a form titled, "Prior Authorization Statement" showed the start date for hospice services to begin was 01/22/2020 and was signed by the patient's power of attorney and checked the box that he/she was the Activated POAHC (Power of attorney for healthcare, allows a selected representative to make healthcare decisions for you). Review of the SN visit note dated 01/23/2020 showed: - Licensed Practical Nurse (LPN) A educated the caregiver about the use of a comfort pack (a supply of medications kept in the home so they will be available to rapidly treat symptoms that may occur) in the home; - The caregiver requested a comfort pack. The caregiver was aware not to open the comfort pack until he/she contacted the hospice nurse when it was needed. The comfort pack will be ordered for the patient. The nurse informed the caregiver, he/she should receive it no later than the following week; and - No documentation of whether the caregiver was the patient's power of attorney or whether the power of attorney was contacted regarding ordering a comfort pack for the home. Review of the clinical record showed the patient's level of care changed to respite care from 01/29/2020 to 02/02/2020 due to the caregiver being out of town. Review of a physician order dated 02/05/2020 showed: - An order for morphine sulfate (Roxanol ,narcotic pain medication) oral solution 100 milligrams (mg)/5 milliliters (ml). Take 0.25 ml (5 mg) by mouth or under the tongue every three hours as needed for shortness of breath or pain; and - An order for a comfort pack (no morphine). Review of the pharmacy's comfort pack contents showed it included: - Acetaminophen 650 mg suppositories. Insert one suppository rectally every six hours as needed for mild pain or fever; - Haloperidol (anti-psychotic medication also used for nausea and vomiting) 2 mg/ml. Take 0.5 ml (1 mg) by mouth or under the tongue every six hours as needed for agitation or nausea and vomiting; - Hyoscyamine 0.125 mg sublingual tablets. Take one tablet under the tongue very four hours as needed for secretions; - Lorazepam 0.5 mg tablets. Take one tablet by mouth every six hours as needed for anxiety or agitation; - Prochlorperazine 10 mg tablets. Take one tablet by mouth every six hours as needed for nausea and vomiting; and - Bisacodyl 10 mg suppository. Insert one suppository rectally once daily as needed for constipation. Review of a pharmacy form (untitled) showed the following comfort pack medications were dispensed on 02/05/2020: - Acetaminophen 650 mg suppositories. Insert one suppository rectally every six hours as needed for mild pain or fever; - Haloperidol (anti-psychotic medication) 2 mg/ml. Take 0.5 ml (1 mg) by mouth or under the tongue every six hours as needed for agitation; - Hyoscyamine 0.125 mg sublingual tablets. Take one tablet under the tongue every four hours as needed for secretions; - Lorazepam 0.5 mg tablets. Take one tablet by mouth every six hours as needed for anxiety or agitation; - Prochlorperazine 10 mg tablets. Take one tablet by mouth every six hours as needed for nausea and vomiting; and - Bisacodyl 10 mg suppository. Insert one suppository rectally once daily as needed for constipation. Review of another pharmacy form (untitled) showed an order dated 02/05/2020 for morphine concentrate 100 mg/5 ml (20 mg/ml). Take 0.25 ml (5 mg) by mouth or under the tongue every three hours as needed for shortness of breath or pain. Dispense quantity 30. Review of the SN visit note dated 02/13/2020 showed LPN A documented the following: - The patient lived with a 24/7 caregiver that alternated with another caregiver; - The patient is not on any routine medications; - The comfort pack was now in the home; - The medications listed under the medication section showed: * Roxanol 5 mg every three hours orally as needed (0.25 ml of 20 mg/ml). Take 0.25 ml every three hours as needed for pain or dyspnea (breathing difficulty); * Acetaminophen (Tylenol) 650 mg every four hours rectally (one suppository) per rectum every four hours for pain or fever; * Lorazepam intensol (anti-anxiety medication) 0.5 mg. Take 0.25 ml PO/SL every four hours as needed for anxiety/terminal restlessness (The pharmacy list showed they dispensed tablets instead of a liquid form); * Levsin 0.125 mg one tablet PO/SL every six hours as needed for increased secretions; and * Zofran 4 mg by mouth every six hours as needed for nausea (This was not included on the list of medications the pharmacy dispensed); * Prochlorperazine 10 mg tablet was not included on this list on the SN note but was included on the pharmacy list as being dispensed on 02/05/2020; - The section for the nurse to assess the patient/family/caregiver and living environment for the risk of diversion showed no check mark by this care plan intervention to indicate the nurse performed this assessment. The nurse only placed a check mark beside the intervention to assess the patient's level of pain each visit; and - No documentation of further education to the caregivers regarding the comfort pack or Roxanol, further assessment of the risk of diversion, or contact with the patient's power of attorney regarding the comfort pack and Roxanol being in the home. Review of the SN note dated 02/18/2020 showed RN B placed a check mark beside assess the patient/family/caregiver and living environment for the risk of diversion. The SN documented in the box below this intervention that the patient resided with family. Review of the SN notes dated 02/21/2020, 02/24/2020, and 02/25/2020 showed LPN A documented the patient did not have pain, anxiety or nausea and vomiting. The comfort pack was now in the home. The caregiver was aware to call the hospice with any concerns, needs or issues. Review of the MSW (master of social work) note dated 02/28/2020 showed: - The patient has a hired caregiver and no identified caregiver strain; - The family has proven to be helpful and supportive of one another; and - The caregiver role is distributed between family and hired staff. Review of the SN note dated 03/02/2020 showed RN B documented: - No answer to the door or phone; - The nurse notified the building manager who entered the home; - The nurse notified the power of attorney who stated the patient's caregiver was in the building and the patient could be left alone; - The nurse informed the power of attorney he/she did not feel comfortable doing this; and - Upon leaving another caregiver showed up and the nurse gave report to the caregiver and instructed him/her to notify hospice of any changes in condition or concerns. Review of the SN (this nurse no longer worked at the agency) visit note dated 03/05/2020 showed: - The hospice received a call from the power of attorney that Roxanol was in the house and opened, and they didn't know who opened the Roxanol or how much was used; - They suspected one of the caregivers may have diverted some of the Roxanol and that the patient was restless; - When the nurse arrived the patient lay in bed with his/her eyes closed; - The patient was somewhat restless and lifting his/her legs in the air; - The nurse examined the Roxanol bottle; - The bottle was not sealed and appeared to have 30 mls in the bottle; - The nurse spoke to the caregiver that was present and spoke to the power of attorney on the phone; - The caregiver suggested that the other caregiver may have put mouthwash in the bottle and diverted the morphine; - The nurse explained that he/she could not tell if it was morphine as he/she was not a pharmacist, but the bottle had 30 mls in it and had been opened; - As the patient was restless, the nurse administered 0.5 ml (10 mg) of Roxanol per the physician (medical director), now; - The patient calmed down and was resting although he/she kept his/her legs elevated in the air; - The nurse delivered a medication administration record and lock box and explained their use; - The power of attorney wanted another bottle of Roxanol delivered as he/she was unsure if the current bottle had been tampered with; - The nurse resealed the bottle with a sticker and educated the caregiver and power of attorney to keep record of every dose and to count the medication after every dose; - The nurse provided medication instruction in great detail; and - The nurse requested they notify the hospice of any concerns or issues. Review of the SN note dated 03/06/2020 showed LPN A documented: - The patient resided in an independent community apartment complex with a 24/7 caregiver that alternated with another caregiver; - The patient was transitioning, staring out and through, speech is garbled, extremities cool and flaccid (limp), unable to eat or drink, no pain, no signs of anxiety, nausea, or dyspnea; - The nurse notified the family of the change in condition; and - No documentation of whether the medications had been checked, whether any further Roxanol had been given since the nurse administered the Roxanol the previous evening, or assessment of the medication administration record to see if any further medication had been administered. Review of a form titled, "Death Visit Report and Drug Disposal Verification," showed: - The date of death was 03/07/2020 at 9:20 AM; - The patient's niece was at the bedside; - The niece refused destruction of the medications; and - The nurse circled and underlined a statement at the bottom of the report that the family refused medication destruction, supervisor and MD (unclear if this means medical director) notified, instructions given for proper disposal. During an interview on 03/11/2020, at 9:10 AM, the administrator (who is also a physician) stated: - The power of attorney had hired two caregivers to care for the patient. One of which was a cousin of the power of attorney, and the other was from an agency. The power of attorney did not live with the patient; - The agency had found out in the past two weeks that the caregivers hated each other; - The nurse taught both caregivers how to give medications; - The nurses instruct the patient/family/caregiver on using the comfort kit medications when the kit arrives at the home; - He/she would expect the nurse to document the instructions they gave; - On 03/05/2020, one of the caregivers called the agency and said he/she thought the other caregiver had tampered with the medication and wanted a nurse to come taste the medication. The nurse told the caregiver that he/she was not a pharmacist, but if they wanted to take it to the pharmacy they could do so; - They provide a lock box for patient's medications if they feel there is a high risk for diversion, but they had not felt this situation was high risk because they did not learn of the conflict with the caregivers until around 03/04/2020; - The nurse should document in their notes that they look at the comfort pack and ask if anything was used; - The administrator talked with everyone at the agency regarding the situation that was evolving and discussed it with the medical director but did not know if he/she had documentation of this; - He/she thought in the case of wanting another bottle of Roxanol, the nurse could order it, then would ask the family to destroy the other bottle; - He/she did not know if another bottle had been ordered; and - LPN A told the administrator he/she instructed both caregivers step by step on how to give the medications. During an interview on 03/11/2020 at 10:27 AM, with Registered Nurse (RN) B and the administrator, RN B stated: - He/she had only seen the patient a couple of times; - Before they order a comfort pack, they discuss it with the patient, caregiver and power of attorney; - When the comfort pack arrives, they teach how to give the medications, side effects, how to store the medication; - After the comfort pack is in the home we check every visit to see if it has been used; - If they are assessed for high risk we document we check the comfort pack; and - He/she did not check the comfort kit during his/her visit because the patient had not been having pain and hadn't used anything. During an interview on 03/11/2020 at 1:12 PM, RN B stated: - At admission he/she tells the families about the comfort packs and that it is available; - If they want a comfort pack, we discuss what is in it and tell them not to open it unless they contact the nurse first and to put it in the back of the refrigerator; - He/she tells the families when they get the comfort pack to let the nurse know; - The high risk patients (show signs they may need to open the comfort kit soon) that get a comfort pack also get a lock box; - We tell them to put all narcotics and comfort pack medications in the lock box after the comfort pack is opened; - If there are no imminent signs of the patient needing the medications right away, it is sealed and put up in the back of the refrigerator; - When the comfort pack is opened, we give the family a lock box because the seal has been broken; and - Patient #1 was not taking any medications so he/she was not a high risk. During an interview on 03/11/2020 at 2:30 PM, LPN A stated: - The caregiver that was also a family member requested the pain medication and comfort pack; - He/she explained what was in it, and there would be instructions to not open it without calling a nurse and to keep it in the back of the refrigerator so he/she would not have to look for it; - The patient went into respite so the comfort pack was put on hold; - On 02/13/2020 he/she told the caregivers not to open the comfort pack until they call the nurse; - He/she was not sure he/she documented talking to the other caregiver about the comfort pack; - He/she was not sure he/she talked to the power of attorney about ordering the comfort pack and Roxanol because he/she thought the caregiver in the home was the power of attorney; - If he/she knew that was not the power of attorney, he/she would have absolutely discussed it with them; - He/she received a call while on call from one of the caregivers but was unsure of the date and time. The patient was restless and grimacing. He/she instructed the caregiver over the phone how to give the Roxanol and if it did not work, he/she would make a visit (There is no documentation regarding this call); - He/she went to visit the following day. The caregiver did not have to use the Roxanol. He/she played some music and the patient had a bowel movement and calmed down; - On another occasion, LPN A received a message from the office to call the other caregiver who was a family member to instruct on how to give medication. The caregiver said the patient was having some pain, restless and grimacing. LPN A instructed the caregiver on how to give the Roxanol. The caregiver said the tape was broken on the comfort pack but did not say the Roxanol had been opened. He/she had the caregiver look at the Roxanol bottle because he/she wanted the caregiver to know how much was in the bottle before he/she gave any of the medication. The caregiver said there were 30 mls in it and it was a blue color; and - He/she did not document this on a note because it was not a visit. The agency did not have on call notes, just prn (as needed) visit notes. During an interview on 03/11/2020 at 3:15 PM, the administrator stated: - He/she did not know if they had a specific policy on placing a comfort pack in the home; - Everyone is supposed to document a case communication note any time they have contact with a patient, caregiver, or family; and - He/she would expect the nurse to discuss any medications with the power of attorney before ordering medications. During an interview on 03/11/2020 at 4:35 PM, the administrator stated: - Just before 5:00 PM on 03/05/2020 he/she talked to their director of nursing (DON, who no longer worked at the agency) that the power of attorney had called; - LPN A told him/her that she had walked the caregiver through giving the Roxanol (There was no documentation regarding this); - The administrator told the DON to take a lock box to the home; - On 03/06/2020 he/she would have expected the nurse to document that he/she checked the medications and Roxanol, especially after what had happened; - He/she would expect the nurse to check to see how many mls were in the bottle, the condition of the seal, and to check the medication record to see if any medications had been used; and - The nurse should document they looked at the medication record and whether anything was given. During an interview on 03/12/2020 at 10:00 AM, the administrator stated: - They are still looking for the patient's medication record; - The patient had just passed over the weekend, and the nurse no longer worked for the agency; - When a patient expired, the nurse should bring the lock box and medication record back with them; - He/she did not know if the lock box had been brought back; - If a family refused to have the medications destroyed, the nurse may have had to leave the lock box for some reason but should document why and bring the medication record back; and - The medication record was not provided by the end of the survey. During an interview on 03/12/2020 at approximately 12:00 (noon), LPN A stated: - He/she did not find documentation where he/she instructed both caregivers regarding the Roxanol and comfort pack; - On 01/23/2020, he/she instructed the caregiver that was a family member on giving the Roxanol and comfort pack medications; - The patient had more than two caregivers because he/she had seen other caregivers leaving the home as he/she was arriving but only interacted with two of the caregivers; - If a patient or family calls and they need to use something out of the comfort pack, he/she goes over what symptoms they are having and based on that decide what is needed and walk them through giving the medication over the phone; -He/she did not necessarily make a visit if it was the first time needing to give medications unless the symptoms were uncontrolled; -The first time one of the caregivers called while he/she was on call, but he/she ended up not needing to give the Roxanol; - He/she thought she turned in a call log about this communication with the caregiver; - It was on 03/05/2020, he/she got a text message at 2:40 PM that the other caregiver called and he/she needed to call them; - He/she opened the Roxanol, and I instructed him/her step by step how to draw up and give the Roxanol; - He/she assumed the caregiver gave the Roxanol because he/she instructed him/her and told the caregiver if it did not work in 15 to 30 minutes to call back, then at that point the DON was on call; - He/she did not document a note because it was not a visit; - He/she had not been instructed to do case communication notes; - On 03/06/2020, he/she did not check the medication record because it was in the lock box and he/she nor the caregiver that was there at that time had the combination; - He/she did not know if any more medication had been given throughout the night; - He/she had not been in a home before that had a lock box; - He/she did not report to anyone that he/she could not get in the lock box; - When the surveyor asked LPN A about the DON's note on 03/05/2020 regarding the caregiver's suspicion of diversion, LPN A said, "I didn't know anything about that" and did not understand because he/she had spoke to the caregiver earlier and he/she was the one who opened it and there was 30 mls in the bottle. During an interview on 03/12/2020 at 12:22 PM, the administrator stated: - When the patients get a comfort pack, the order tells them to notify the nurse or physician before using; - The nurse should notify the physician if a medication has been started; - The nurse fills out a log if a patient calls while on call and should document a case communication note if they have contact about a patient during the day; and -He/she did not have the call logs for March, 2020 because the nurse that was on call no longer worked for the agency and had not turned in the log. Review of the on call logs for January and February, 2020 provided by the administrator on 03/12/2020, at approximately 12:30 PM showed no call about the patient's caregiver calling and LPN A instructing how to give the Roxanol. The only call logged was on 02/04/2020, when the patient had a fall. During an interview on 03/12/2020, at 2:18 PM, with the office manager and administrator, the office manager showed on his/her phone where he/she sent a text to LPN A on 03/05/2020 to call the family to instruct them on giving medication. The administrator said LPN A should have documented a case communication note regarding the call. During an interview on 03/12/2020 at 2:22 PM, the administrator stated: - He/she told the DON about LPN A's call to the caregiver and instructed the DON to take a lock box to the home; - The patient, caregiver, power of attorney and nurses have the combination to the lock box; and - On 03/06/2020, LPN A should have called the DON if he/she did not have the combination to the lock box.