Every finding on record at Amedisys Home Health of Alabama, LLC

Based on the recertification survey conducted on 3/16/21 to 3/18/21, Amedisys Home Health of Opelika was found to be in substantial compliance with the Conditions for Participation for Emergency Preparedness.

A recertification survey was conducted on 3/16/21 to 3/18/21. Standard level deficiencies were cited.

Written notice for non-covered care CFR(s): 484.50(c)(8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. This ELEMENT is not met as evidenced by: Based on review of medical record (MR), policy and procedure and interviews, it was determined the agency failed to obtain a signed copy of the written notice of Medicare Non-Coverage prior to discharge from the agency. This affected 1 of 2 discharge for cause records reviewed including MR # 5 and had the potential to affect all patients served by the agency. Findings include: Policy: Discharge of Patients Policy number: AA - 016 Date revised: 11/2019 Purpose: ...To have a discharge process to ensure the patient is being discharged appropriately and arrangements have been made to address any ongoing health care needs the patient may have at the time of discharge. Procedure: 1. The Home Health Agency (HHA) is responsible to provide care, treatment and services within it's capabilities... 2. The HHA may only transfer or discharge the patient from the HHA for: ...E. Discharge for cause: 1. The patient's (or other persons in the patient's home) behavior is disruptive, abusive, or uncooperative to the extent that delivery of care to the patient or the ability of the HHA to operated effectively is seriously impaired. 2. Examples include: ...The patient's home environment will not support the provision of home health services. ...The patient cannot care for him/herself in between visits from Agency personnel and no reliable pain or voluntary caregiver is available to meet all of needs of the patient between visits by the Agency staff. ...The patient and/or primary caregiver are noncompliant or have a documented history of noncompliance in cooperating to attain the objectives of home care. ...If decision is made to terminate services, staff will normally verbally notify non-institutionalized patients and their attending physicians at least 2 days prior to discharged of the date and time of termination of services and the reason(s) for termination... ...Verbal notification to non-institutionalized patients not in jeopardy will normally be immediately followed by written notice(Notice of Medicare Non-Coverage)... A copy of the written notice shall be placed in the patient's chart... MR # 5 was admitted to the agency on 11/21/2020 with diagnoses including Type 2 Diabetes Mellitus with Hyperglycemia, Type 2 Diabetes Mellitus with Diabetic Neuropathy, and Neuromuscular Dysfunction of the Bladder. Review of the Client Coordination Note Report dated 12/23/2020 revealed the nurse documented "Informed the patient that he/she may be discharged next visit if he/she continues not to follow physician Plan of Care and allow nursing to assist him/her. Patent verbalizes understanding. Physician notified last visit." There was no documentation of a signed Notice of Medicare Non-Coverage. Review of the Skilled Nurse (SN) Visit Note Report dated 1/8/2021 at 4:31 PM and the Client Coordination note dated 1/8/2021 revealed the Registered Nurse (RN) discharged the patient from the agency due to patient refusal to follow physician plan of care. An interview was conducted on 1/18/2021 at 11:45 PM with Employee Identifier (EI) # 1, Interim Director of Operations, who confirmed there was no documentation of notification to the patient of the planned discharge and no Notice of Medicare Non-Coverage had been signed by patient.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on review of Medical Records (MR), policy and procedure and interviews, it was determined the agency failed to ensure: 1. Medication profile was updated periodically to include new, changed, or discontinued medications. 2. A complete list of medication were obtained and entered in the Medication Profile at the start of care. 3. Medications were taught by the nurse as indicated. This deficient practice affected 5 of 13 MR reviewed including Home Visit (HV) # 1, MR # 6, HV # 2, HV # 3 and HV # 4 and had the potential to affect all patients served by this agency. Findings include: Policy: Drug Regimen Review Policy #: MA - 002 Revised: 01/2020 Purpose: To identify appropriateness, inconsistencies, and/or significant drug interactions in the patient's current medication regiment, as well as ensure the comprehensive list of medications are updated any time there is a medication change including dose changes, new medications, and any medications discontinued. Procedure: 1. The clinician completing the OASIS Assessment must complete a comprehensive drug regimen review of all medications the patient is currently taking at the time of admission ... 2. The clinician will question the patient and/or caregiver periodically regarding changes in medications including dosage changes, any new medications added, or any medications discontinued. ... 3. Initially and ongoing: Medications are taught by the nurse as indicated to ensure effective and safe drug therapy. ... 1. HV # 1 was admitted to the agency on 3/1/2021 with diagnoses including Displaced Intertrochantor Fracture of the Right Femur, Urinary Tract Infection, and Ischemic Cardiomyopathy. A HV visit was conducted on 3/16/2021 at 11:10 AM with Employee Identifier (EI) # 8, Physical Therapist (PT) to observe care provided. A review of the home medications was performed by EI # 8 which included the following medication discrepancies: Alprozolam 0.25 mg (milligrams) listed on the Client Medication Report (CMR) to be taken BID (twice a day). HV # 1 stated he/she takes it 1 to 2 times a day as needed. Loratadine 10 mg prescription to be taken daily was in the home but not on the CMR. Date on prescription 1/1/2021. HV # 1 stated he/she is currently taking it daily. Rosuvastin 5 mg to be taken every evening was in the home but not on the CMR. Date on the prescription was 1/16/2021. HV # 1 stated he/she is currently taking it daily. Meclizine 25 mg daily was listed on the CMR. The prescription bottle read tid (three times daily). HV # 1 stated he/she takes the medication 1 to 2 times a day as needed. An interview was conducted on 3/18/2021 at 11:40 AM with EI # 2, Vice President of Clinical Practice, who confirmed the above findings of medication discrepancies. 2. MR # 6 was admitted to the agency on 10/21/2020 with diagnoses including Essential (Primary) Hypertension, Tremor, Unspecified, Schizophrenia, Unspecified, and Unspecified Visual Loss. Review of the Home Health Certification (HHC) and Plan of Care (POC) dated 10/21/2020 to 12/19/2020 revealed a SN (Skilled Nurse) frequency of once a week for "medication management; skilled nurse (SN) to review medications for interactions, effectiveness of drug therapy, and signs/symptoms of adverse reactions..." Review of the CMR revealed documentation of Benztropine 2.5 mg twice a week started on 9/16/2020. There was no documentation of any other medications on the CMR. Review of the RN (Registered Nurse) Admission note dated 10/21/2020 revealed documentation of "...patient will be admitted for medication management and teaching... Medication rec (reconciliation) not completed as medications are not within the home. (Case Manager for mental health center identified) to fax current list of medications from (mental health center identified)..." Review of the Occuptional Therapy (OT) evaluation dated 10/22/2020 revealed documentation of "...in regards to medication. Patient keeps ziploc bag of medicine under that (the) mattress. Blister packs inside are to be taken in the morning and small envelope outside bag is to be taken at night..." There is no documentation of what medication was found in the home. Review of the Mental Health Center Client Medication Filter, faxed and entered into the agency system on 11/4/2020 per EI # 1, Interim Director of Operations, revealed MR # 6 was prescribed the following: Benztropine 2 mg 1 tablet twice a day; Gabapentin 600 mg 1 tablet three times a day; Haldol Decanoate 100mg/ml (mililter) solutation 150 mg intramuscularly every 4 weeks; Lexapro 20 mg 1 tablet daily; Trelegy Ellipta 100-62.5-25 mcg (micrograms) 1 inhalation as directed once a day, Ingrezza 80 mg daily; Zyprexa 15 mg 1 tablet at bedtime; and losartan 100mg 1 tablet every morning. Review of the Skilled Nurse Visit (SNV) dated 11/12/2020 revealed documentation of "Patient states he/she has side effects from medications...states this has been going on for over a year...states it is the haldol injection...." Review of the MR revealed no documentation a medication reconciliation was performed. An interview was conducted on 3/18/21 at 10:27 AM with EI # 2, who confirmed there was no documentation of a medication reconilitation for MR # 6 and there was no documentation the patient was on any medications other than Benztropine. 3. HV # 2 was admitted to the agency on 2/5/21 with diagnoses including Amyotrophic Lateral Sclerosis and Dysphagia, Oropharyngeal Phase. A HV was conducted on 3/16/21 at 12:00 PM with EI # 5 to observe care provided. A review of the home medications was performed by EI # 5, Occupational Therapist, and the following were found in the home, verified by the patient, and not listed on the CMR: Melatonin 3mg 1/2 tablet at bedtime, which the patient verbalized he/she had been taking "a year." Nutrilite Multivitamin 1 tablet weekly, which the patient verbalized he/she had been taking for "years." Vitamin D3 2,000 IU (International units) 1 tablet daily, which the patient verbalized he/she had been taking for "a year." Docusate Sodium 100mg 1 tablet daily, which the patient verbalzied he/she had been taking "off and on a long time but regular since September." Loratadine 10mg 1 tablet daily, which the patient verbalized he/she had been taking "since September." Cyclobenzaprine 10mg 1 tablet at bedtime with prescribed date on medication bottle as 10/31/19. An interview was conducted on 3/18/21 at 10:11 AM with EI # 2, who confirmed the previous medication were not on the agency CMR. 4. HV # 3 was admitted to the agency on 3/9/2021 with diagnoses including Type 2 Diabetes Mellitus with foot ulcer, Non-Pressure Chronic Ulcer of Right Heel and Midfoot Limited to Breakdown of Skin and Chronic Obstructive Pulmonary Disease, Unspecified. A HV visit was conducted on 3/16/2021 at 2:45 PM with EI # 6, Licensed Practical Nurse (LPN) to observe care provided. A review of the home medications was performed by EI # 6 which included the following medication discrepancies: Basaglar Insulin Pen 25 units every hour of sleep found in the home as of November 2020 per HV # 3, and not on the CMR provided to the Surveyor for the home visit. Novolin 70-30 FlexPen U-100 Insulin 100 Unit/ML(Unit per Milliliter) (70-30) Subcutaneous found on the CMR provided to the Surveyor and discontinued November 2020 per HV # 3. Escitalopram 10 mg tablet one daily found on the CMR but not found in the home and per HV # 3, medication has not been taken "in a long time". An interview conducted on 3/18/2020 at 10:05 AM with EI # 2, AVP Clinical Practice confirmed the medication discrepancies on the agency CMR. 5. HV # 4 was admitted to the agency on 11/11/2020 with diagnosis including Encounter for Adjustment and Management of Vascular Access Device (VAD), Atherosclerotic Heart Disease of Native Coronary Artery without Angina Pectoris, and Hypertensive Heart and Chronic Kidney Disease Without Heart Failure and Stage 1-4 Unspecified Chronic Kidney Disease. A HV visit was conducted on 3/16/2021 at 12:45 PM with EI # 7, Registered Nurse (RN) to observe care provided. A review of the home medications was performed by EI # 7 which included the following medication discrepancies: Cyanocobalamin (Vitamin B-12) 1000 MCG (Microgram) Tablet, one daily found on CMR and per HV # 4 and caregiver, has been taking 2500 MCG daily for "several weeks." Hydrocodone 5 mg -Acetaminophen 325 mg Tablet one as needed found on the CMR, but medication not found in the home and per caregiver, discontinued in December of 2020. Omeprazole 20 mg capsule, delayed release found on the CMR, but medication discontinued December 2020 per HV # 4 and caregiver. Potassium Chloride ER 20 MEQ Tablet, Extended Release, one tablet daily on CMR but per caregiver and HV # 4, takes 10 MEQ daily as of 3/1/2020. An interview conducted on 3/18/2020 at 10:05 AM with EI # 2, AVP Clinical Practice confirmed the medication discrepancies on the agency CMR.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on Medical Record (MR) review, policy and procedure and interviews, it was determined the agency failed to insure the referral orders and the orders in the Plan of Care were followed for: 1. Medical Social Worker evaluation. 2. Review of medications for interactions, effectiveness of drug therapy, and signs/symptoms of adverse reactions as ordered by the physician. This affected 2 of 13 MR, including MR # 5 and MR # 6 had the potential to affect all patients served by the agency. Findings include: Policy: Coordination of Care Policy Number: TX - 002 Date revised: 04/2019 Purpose: The patient's care and services will be coordinated among staff and branches. ...To utilize/recommend appropriate internal and external resources as needed throughout the length of service. ...Procedure: ...In the event an ordered service cannot be performed, the physician shall be notified and new orders obtained as indicated. The patient will be referred to another provider accordingly. 1. MR # 5 was admitted to the agency on 11/21/2020 with diagnoses including Type 2 Diabetes Mellitus with Hyperglycemia, Type 2 Diabetes Mellitus with Diabetic Neuropathy, and Neuromuscular Dysfunction of the Bladder. Review of the Physician referral order dated 11/16/2020 revealed "Patient schedule to discharge home with Home Health with SN (Skilled Nurse), med (medication) management, catheter care, social worker eval (evaluation), PT (Physical Therapy), OT (Occupational Therapy), ST (Speech Therapy) eval and treat." Review of the visit notes dated 11/21/2020 through 1/8/2021 revealed no documentation of a social worker evaluation or visit. An interview was conducted on 3/18/2021 at 11:45 AM Employee Identifier (EI) # 1, Interim Director of Operations, confirmed there was no social worker evaluation or visit documented on MR # 5. EI # 1 stated they did not have social worker employed in the office at the time of the patients certification period. 2. MR # 6 was admitted to the agency on 10/21/2020 with diagnoses including Essential (Primary) Hypertension, Tremor, Unspecified, Schizophrenia, Unspecified, and Unspecified Visual Loss. Review of the Home Health Certification (HHC) and Plan of Care (POC) dated 10/21/2020 to 12/19/2020 revealed a SN (Skilled Nurse) frequency of once a week for "medication management; skilled nurse (SN) to review medications for interactions, effectiveness of drug therapy, and signs/symptoms of adverse reactions... Review of the Client Medication Report (CMR) revealed documentation of Benztropine 2.5 mg twice a week started on 9/16/2020. There was no other medication listed on the CMR Review of the RN (Registered Nurse) Admission note dated 10/21/2020 revealed documentation of "...patient will be admitted for medication management and teaching... Medication rec (reconciliation) not completed as medications are not within the home. (Case Manager for mental health center identified) to fax current list of medications from (mental health center identified)..." Review of the Occupational Therapy (OT) evaluation dated 10/22/2020 revealed documentation of "...in regards to medication. Patient keeps Ziploc bag of medicine under that (the) mattress. Blister packs inside are to be taken in the morning and small envelope outside bag is to be taken at night..." There is not documentation of what medication was found in the home." Review of the Mental Health Center Client Medication Filter, faxed and entered into the agency system on 11/4/2020 per EI # 1, Interim Director of Operations, revealed MR # 6 was prescribed the following: Benztropine 2 mg 1 tablet twice a day; Gabapentin 600 mg 1 tablet three times a day; Haldol Decanoate 100 mg/ml (mililter) solution 150 mg intramuscularly every 4 weeks; Lexapro 20 mg 1 tablet daily; Trelegy Ellipta 100-62.5-25 mcg (micrograms) 1 inhalation as directed once a day, Ingrezza 80 mg daily; Zyprexa 15 mg 1 tablet at bedtime; and Losartan 100 mg 1 tablet every morning. Review of the Skilled Nurse Visit (SNV) dated 11/12/2020 revealed documentation of "Patient states he/she has side effects from medications...states this has been going on for over a year...states it is the Haldol injection...." Review of the MR revealed no documentation the SN reviewed medication for interactions, effectiveness of drug therapy, or monitored for signs/symptoms of any medication other than Benztropine. An interview was conducted on 3/18/21 at 10:27 AM with EI # 2, who confirmed there was no documentation of the SN review of medications for interaction, effectiveness of drug therapy, signs/symptoms of adverse reactions or medication management on any medications other than Benztropine.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on review of medical records (MR), agency policy and procedure and interviews with agency staff, it was determined the agency failed to ensure: 1. The staff notified the physician of noncompliance with medication related to disease process. 2. The physician was notified of a caregiver report of patient new onset confusion and concern the confusion was related to medication. This deficient practice affected 1 of 2 MR's reviewed for a discharge for cause, including MR # 6 and 1 of 1 on call telephone calls, including unsampled patient # 1, and had the potential to negatively affect all patients serviced by the agency. Findings Include: Policy: TX-002 Subject: Coordination of Care Revised: 4/2019 Purpose: ...To utilize/recommend appropriate internal and external resources as needed throughout the length of service. To ensure consistent documentation, communication, coordination, and retrieval of significant administrative and patient/family information. Procedure: ...4. Relevant physicians are notified promptly of any changes in the patient's condition or needs that suggest than (the) outcomes are not being achieved and/or that the plan of care should be altered... 1. MR # 6 was admitted to the agency on 10/21/2020 with diagnoses including Essential (Primary) Hypertension, Tremor, Unspecified, Schizophrenia, Unspecified, and Unspecified Visual Loss. Review of the Home Health Certification (HHC) and Plan of Care (POC) dated 10/21/2020 to 12/19/2020 revealed a SN (Skilled Nurse) frequency of once a week. Review of the RN (Registered Nurse) Admission note dated 10/21/2020 revealed the following documentation: "Primary focus of visit was admission to home health secondary to multiple ER (Emergency Room) visits, need for medication management teaching... Patient noted to be living in a hotel room. All care is overseen by (mental health center identified) due to Schizophrenia and Blindness. Patient is unable to manage self care due to blindness and mental health exacerbations. Case Manager...from (mental health center identified) is responsible for all patient care; notably, daily medication administration, shopping laundry, and all finances. He/She (case manager) visits daily Monday through Friday, but is unable on the weekends. Patient has no medication on the weekend and therefore has exacerbation of mental illness which is the reason behind ER visits...Patient will be admitted for medication management and teaching..." Service to be provided documented as "...MSW (Medical Social Worker)." Review of the SNV (Skilled Nurse Visit) dated 10/29/2020 revealed documentation of "...Patient states that he/she knows he/she needs to take his/her medication correctly but he/she just can't bring himself/herself to do it..." There was no documentation the physician was updated due to the patient stating he/she could not bring themselves to take the medication which could affect treatment effectiveness and require a change to the POC. Review of the SNV dated 11/5/2020 revealed documentation of "...patient continues to refuse medication reminders such as pill planner and states that he/she just isn't able to do it because his/her will is not strong enough..." There was no documentation the physician was notified of the patient's statement of his/her will not being strong enough which could affect treatment effectiveness and require a change to the POC. Review of the RN Discharge from Agency note dated 11/20/2020 revealed documentation of an ER visit without admission since the last agency visit for "improper medication administration..." Review of the Discharge Summary dated 11/20/2020 revealed documentation of the reason for discharge as "patient refusal to follow physician plan of care and therefore is not able to meet goals..." An interview was conducted on 3/18/21 at 10:27 AM with EI # 2, Area Vice President of Clinical Practice, who confirmed there was no documentation the physician was notified of the patient's statement regarding the reason he/she was unable to take medication and follow the ordered POC. 2. Review of the on call log dated 2/18/2021 at 6:15 PM revealed documentation of a call from the caregiver (cg) of unsampled patient # 1 who verbalized the patient was "...very disoriented this morning after taking Benadryl, a pain med (medication), and a couple of other medications....states (patient) is still disoriented at this time and is questioning several side effect/interactions between different medication combinations...instructed cg to call pt's (patients) local pharmacist to discuss interactions...." There was no documentation the physician was notified about the patient's condition and cg concern the condition was related to the patient's medications. Review of the on call log dated 2/19/21 at 4:57 AM revealed documentation of a call from the cg of unsampled patient # 1 who verbalized "...called the ambulance to pick up...(patient)...that had fallen bc (because) she/he couldn't get her/him up...states (patients) speech was very slurred and ...was even more disoriented...states she/he did call the pharmacist after we talked who discussed pt's meds and interactions and told her/him which meds to hold last night that could be causing the issues, but she/he states pt has continued to declined (decline) and she/he wanted to make us aware that pt is otw (on the way) to (hospital identified). The agency failed to notified the physician of the cg's report of patient's condition and concern regarding medications administered which resulted in the patient falling and need for evaluation at a hospital. An interview was conducted on 3/18/21 at 11:07 AM with EI # 2, who confirmed there was no documentation the physician was notified of the cg's report of the patient's condition and concern regarding medication side effects/interactions.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on Medical Record (MR) reviews, agency policy and procedure, and interview with staff, it was determined the agency failed to coordinate care delivery with the mental health center and physician providing care to the patient, which affected MR # 6. This did affect 1 of 1 MR reviewed receiving mental health agency services and had the potential to negatively affect all patient's served by the agency. Findings Include: Policy: TX-002 Subject: Coordination of Care Revised: 4/2019 Purpose: ...To utilize/recommend appropriate internal and external resources as needed throughout the length of service. To ensure consistent documentation, communication, coordination, and retrieval of significant administrative and patient/family information. Procedure: ...3. The Clinical Manager/designee is assigned to supervise and coordinate care for a patient: a. Has the primary responsibility to notify the attending physician and other agency staff of any significant changes in the patient's status ...c. Manages and oversees coordination/integration of care and services by all disciplines to meet the patient's needs and identify factors that could affect...treatment effectiveness... 4. Relevant physicians are notified promptly of any changes in the patient's condition or needs that suggest than (the) outcomes are not being achieved and/or that the plan of care should be altered... ...13. In the event an ordered service cannot be performed, the physician shall be notified and new orders obtained as indicated. The patient will be referred to another provider accordingly. ...14. When care is provided by organizations...outside the agency...the clinician or designee... is aware of these specific responsibilities and share the same with agency staff...ensure communication of significant changes in care... 1. MR # 6 was admitted to the agency on 10/21/2020 with a diagnoses including Essential (Primary) Hypertension, Tremor, Unspecified, Schizophrenia, Unspecified, and Unspecified Visual Loss. Review of the Home Health Certification (HHC) and Plan of Care (POC) dated 10/21/2020 to 12/19/2020 revealed a SN (Skilled Nurse) frequency of once a week. Review of the RN Admission note dated 10/21/2020 revealed the following documentation: "Primary focus of visit was admission to home health secondary to multiple ER (Emergency Room) visits, need for medication management teaching... Patient noted to be living in a hotel room. All care is overseen by (mental health center identified) due to Schizophrenia and Blindness. Patient is unable to manage self care due to blindness and mental health exacerbations. Case Manager...from (mental health center identified) is responsible for all patient care; notably, daily medication administration, shopping laundry, and all finances. He/She (case manager) visits daily Monday through Friday, but is unable on the weekends. Patient has no medication on the weekend and therefore has exacerbation of mental illness which is the reason behind ER visits...Patient will be admitted for medication management and teaching..." Service to be provided documented as "...MSW (Medical Social Worker)." Further review of the RN Admission note dated 10/21/2020 revealed no documentation of a discussion with the Case Manager from the mental health center on how to address the patient receiving medications over the weekend to help prevent an exacerbation of the mental illness. Review of the SN Phone visit dated 10/23/2020 revealed documentation of "(Case Manager)...still in charge of medication at this time and brings them Monday through Friday to assist with medication adherence....states that patient will have a nurse coming out throughout the weekend to help with his/her medication." There was no documentation of where the nurse was from and if the nurse would be to provide help with medications for future weekends. Review of the SNV (Skilled Nurse Visit) dated 10/29/2020, next SN visit, revealed documentation of "...Case Manager cannot bring his/her (patient) medications daily. Case Manager...continues to bring medications daily throughout the week but cannot come over the weekend which is when (the) patient continues to have mental illness exacerbations. Patient states that he/she knows he/she needs to take his/her medication correctly but he/she just can't bring himself/herself to do it...Patient refused pill planner...Case Manager called with no response...will call again in the afternoon to update on patient status..." There was no documentation of a follow up by the agency staff about the nurse visit mentioned in the phone visit dated 10/23/2020. Review of the MR revealed no documentation the Case Manager and the physician were updated due to the patient stating he/she could not bring themselves to take the medication which could affect treatment effectiveness and require a change to the POC. Review of the SNV dated 11/5/2020 revealed documentation of "...patient continues to refuse medication reminders such as pill planner and states that he/she just isn't able to do it because his/her will is not strong enough. Case Manager...called and formed (informed) of patient status and refusal to follow suggested medication helpers and reminders. Case Manager and patient informed that patient may be discharged soon if nursing cannot provide another skill that patient is acceptable to..." There was no documentation the physician was notified of the patient's statement of his/her will not being strong enough and no documentation of discussion of other interventions to aid patient's ability to take his/her medications correctly with the Case Manager and/or physician. Review of the RN Discharge from Agency note dated 11/20/2020 revealed documentation of an ER visit without admission since the last agency visit for "improper medication administration..." Review of the Discharge Summary dated 11/20/2020 revealed documentation of the reason for discharge as "patient refusal to follow physician plan of care and therefore is not able to meet goals..." Review of the MR revealed there was no documentation of a MSW and/or MHN (Mental Health Nurse) referral. An interview was conducted on 3/17/21 at 12:44 PM with EI # 6, Licensed Practical Nurse, who provided care to MR # 6. EI # 6 was asked if he/she recalled what interventions were performed to assist the patient with being complaint with medications. EI # 6 stated, "...we gave him/her a med (medication) planner to help." EI # 6 was asked if the agency staff attempted any other interventions to aid medication compliance. EI # 6 stated, "not that I remember." EI # 6 was asked if he/she felt there was any other interventions the agency could have attempted to aid the patient's medication noncompliance prior to discharge. EI # 6 stated, "adding the visits for the weekend...If it was an option to do more visits even if it was not billed for might have helped..." An interview was conducted on 3/18/21 at 10:27 AM with EI # 2, Area Vice President of Clinical Practice, who confirmed the only documented nursing intervention attempted to aid patient in taking his/her medication correctly was the medication planner. EI # 2 also confirmed there was no documentation the physician was notified of the patient's statement regarding the reason he/she was unable to take medication and follow the ordered POC. EI # 2 confirmed there was no documentation if a nurse other than the agency nurse visited the patient or any coordination of care occurred with an outside nurse. EI # 2 was asked if the agency had MSW and/or MHN coverage during the time of the patient's episode of care. EI # 2 verbalized the agency did not have a MSW or MHN on staff and would most likely refer the patient to another agency or have another branch of the agency provide the MSW and/or MHN services if ordered. EI # 2 verbalized there was no documentation MR # 6 was transferred to another agency following discharge and no documentation of an MSW and/or MHN referral.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on review of agency policies and procedures it was determined the agency failed to ensure the staff followed agency policy and procedure and infection control and sharps disposal. This affected 3 of 5 Home Visits (HV), including HV# 2, HV # 3 and HV # 4. This deficient practice has the potential to negatively affect all patients services by the agency. Findings include: Policy: PCP-001 Subject: Hand Hygiene Revised 9/18 Purpose: To prevent the spread of infection by contaminated hands. ...Guidelines: ...4. Perform hand hygiene as follows: a. Before having direct contact with patients b. Before donning gloves ...d. After contact with patient's intact skin ...g. After contact with inanimate objects...in the immediate vicinity of the patient h. After removing gloves ...Hand Hygiene Procedure: ...2. Use of soap and water: ...c. Regulate flow of water so that temperature is warm. ...i. Turn off water faucet using a clean, dry paper towel... Policy: PCP-002 Subject: Bag Technique Revised: 10/13 Purpose: To provide guidelines for the adherence of the principles of infection prevention in relationship to practitioner equipment and supply bag usage. Procedure: ...4. The field staff member cleanses hands prior to accessing materials and after returning materials to the supply bag with the exception of the soap and paper towels or antibacterial hand gel in the supply bag. Policy: PCP-004 Subject: Hazardous Materials/Waste Management Revised: 1/28/21 Purpose: ...To perform tasks in a way that will minimize or eliminate exposure to hazardous materials/wastes. To provide guidance in handling hazardous materials/waste. To plan and provide education to patients and staff regarding the identification and management of hazardous materials/waste. Procedure: ...9. Disposal ...c. Used needles/syringes and other sharps are disposed of in a puncture-resistant, leak-proof, impervious container. The container should be labeled with a biohazard sign/symbol or color-coded... 1. HV # 2 was admitted to the agency on 2/5/21 with diagnoses including Amyotrophic Lateral Sclerosis and Dysphasia, Oropharyngeal Phase. A HV was conducted on 3/16/21 at 12:00 PM with Employee Identifier (EI) # 5, Speech Therapy, to observe care provided. EI # 5 performed hand hygiene using soap and water at the patients sink but failed to adjust the temperature of the water to warm prior to performing hand hygiene which lead to the water temperature being too hot, steam observed rising from water, requiring EI # 5 to adjust water temperature with bare hand after cleansing hands. Following adjust water tempature, EI # 5 rinsed and dried hands with a paper towel. EI # 5 disposed of paper towel in waste receptacle located in a kitchen cabinet and preceded to close kitchen cabinet with bare hand. EI # 5 then entered and removed equipment needed for visit from supply bag. EI # 5 donned gloves without performing hand hygiene, obtained the patient's blood pressure, and removed gloves. EI # 5 failed to perform hand hygiene prior to direct patient care, donning gloves, and after removing gloves. EI # 5 documented on the Electronic Medical Record (EMR) tablet, donned gloves, documented on the EMR again, then obtains patient pulse. EI # 5 failed to perform hand hygiene after contact with an inanimate objects in the immediate vicinity of the patient and prior to donning gloves. EI # 5 documented pulse on EMR tablet then removed gloves and entered supply bag. EI # 5 failed to perform hand hygiene after removing gloves and prior to entering supply bag. EI # 5 cleaned equipment used during the visit then placed cleaned equipment into supply bag without hand hygiene. EI # 5 donned gloves without hand hygiene and obtains patient medication bottles and verifies medication in the patient medication profile. EI # 5 then documents on the patient's home folder using pen from uniform pocket. EI # 5 replaces pen in uniform pocket without cleaning pen prior to or after use. EI # 5 removed gloves, donned gloves and proceed to palpate patient throat. EI # 5 failed to perform hand hygiene after removing gloves, prior to donning gloves, and prior to direct patient contact. EI # 5 removed gloves and documented on the EMR tablet. EI # 5 failed to perform hand hygiene after removing gloves. An interview was conducted on 3/16/21 at 12:00 PM with EI # 1, Interim Director of Operations, who confirmed the previous was not in compliance with the agency infection control policies. 2. HV # 3 was admitted to the agency on 3/9/2021 with diagnoses including Type 2 Diabetes Mellitus with foot ulcer, Non-Pressure Chronic Ulcer of Right Heel and Midfoot Limited to Breakdown of Skin and Chronic Obstructive Pulmonary Disease, Unspecified. A HV visit was conducted on 3/16/2021 at 2:45 PM with EI # 6, Licensed Practical Nurse (LPN) to observe care provided. EI # 6 performed hand hygiene, donned gloves and performed a finger stick using a lancet to obtain a blood sample from HV # 3's finger to check his/her blood sugar. EI # 6 attempted to discard the used lancet in HV # 3's needle disposal container but was unable to fit the lancet through the opening of the used needle container. EI # 6 then placed the used lancet inside a discarded glove and disposed the lancet in the patient's trash. An interview conducted on 3/18/2021 at 10:05 AM with EI # 1, Interim Director of Operations confirmed proper sharps disposal was not performed. 3. HV # 4 was admitted to the agency on 11/11/2020 with diagnosis including Encounter for Adjustment and Management of Vascular Access Device (VAD), Atherosclerotic Heart Disease of Native Coronary Artery without Angina Pectoris, and Hypertensive Heart and Chronic Kidney Disease Without Heart Failure and Stage 1-4 Unspecified Chronic Kidney Disease. A HV was conducted on 3/16/21 at 12:45 PM with Employee Identifier (EI) # 7 Registered Nurse (RN) to observe care provided. EI # 7 performed hand hygiene, entered nursing bag and replaced cleaned equipment after use. EI # 7 then accessed electronic device and donned gloves and removed a part of the VAD dressing without performing hand hygiene. EI # 7 performed hand hygiene, opened sterile glove packet, donned sterile gloves and measured HV # 4's arm circumference touching HV # 4's arm and clothing with sterile gloved hands. Without changing gloves or performing hand hygiene, EI # 7 obtained sterile supplies, and then removed the soiled dressing from HV # 4's VAD access site. EI # 7 then adjusted eye goggles stating, "my glasses are fogging up," and continued to apply clear dressing over VAD access area and labeled dressing. Using same gloves, EI # 7 retrieved sterile injection caps from sterile packaging and removed injection caps from HV # 4's VAD and replaced with sterile injection caps without performing hand hygiene or doffing and donning new gloves. EI # 7 completed the VAD care, removed gloves and performed hand hygiene and then gathered trash consisting of old dressing and used gloves without donning new gloves or performing hand hygiene after disposing of trash. An interview conducted on 3/18/2021 at 10:05 AM with EI # 2, Area Vice President of Clinical Practice confirmed proper hand hygiene was not performed.

Coordinate patient care CFR(s): 484.105(c)(2) Coordinating patient care, This ELEMENT is not met as evidenced by: Based on Medical Record (MR) reviews, agency policy and procedure, and interview with staff, it was determined the agency Clinical Manager failed to coordinate care delivery with the mental health center and physician providing care to the patient, which affected MR # 6. This did affect 1 of 1 MR reviewed receiving mental health agency services and had the potential to negatively affect all patient's served by the agency. Policy: TX-002 Subject: Coordination of Care Revised: 4/2019 Purpose: ...To utilize/recommend appropriate internal and external resources as needed throughout the length of service. To ensure consistent documentation, communication, coordination, and retrieval of significant administrative and patient/family information. Procedure: ...3. The Clinical Manager/designee is assigned to supervise and coordinate care for a patient: a. Has the primary responsibility to notify the attending physician and other agency staff of any significant changes in the patient's status ...c. Manages and oversees coordination/integration of care and services by all disciplines to meet the patient's needs and identify factors that could affect...treatment effectiveness... ...17. The Clinical Manager/designee is assigned to supervise and coordinate care for a patient. The Clinical Manager/designee shall have the primary responsibility to notify the attending physician and other agency staff of any significant changes in the patient's status. 1. MR # 6 was admitted to the agency on 10/21/2020 with diagnoses including Essential (Primary) Hypertension, Tremor, Unspecified, Schizophrenia, Unspecified, and Unspecified Visual Loss. Review of the Home Health Certification (HHC) and Plan of Care (POC) dated 10/21/2020 to 12/19/2020 revealed a SN (Skilled Nurse) frequency of once a week. Review of the RN (Registered Nurse) Admission note dated 10/21/2020 revealed the following documentation: "Primary focus of visit was admission to home health secondary to multiple ER (Emergency Room) visits, need for medication management teaching... Patient noted to be living in a hotel room. All care is overseen by (mental health center identified) due to Schizophrenia and Blindness. Patient is unable to manage self care due to blindness and mental health exacerbations. Case Manager...from (mental health center identified) is responsible for all patient care; notably, daily medication administration, shopping laundry, and all finances. He/She (case manager) visits daily Monday through Friday, but is unable on the weekends. Patient has no medication on the weekend and therefore has exacerbation of mental illness which is the reason behind ER visits...Patient will be admitted for medication management and teaching..." Service to be provided documented as "...MSW (Medical Social Worker)." Further review of the RN Admission note dated 10/21/2020 revealed no documentation of a discussion with the Case Manager from the mental health center on how to address the patient receiving medications over the weekend to help prevent an exacerbation of the mental illness. Review of the SN Phone visit dated 10/23/2020 revealed documentation of "(Case Manager)...still in charge of medication at this time and brings them Monday through Friday to assist with medication adherence....states that patient will have a nurse coming out throughout the weekend to help with his medication." There was no documentation of where the nurse was from and if the nurse would be to provide help with medications for future weekends. Review of the SNV (Skilled Nurse Visit) dated 10/29/2020, next SN visit, revealed documentation of "...Case Manager cannot bring his/her (patient) medications daily. Case Manager...continues to bring medications daily throughout the week but cannot come over the weekend which is when (the) patient continues to have mental illness exacerbations. Patient states that he/she knows he/she needs to take his/her medication correctly but he/she just can't bring himself/herself to do it...Patient refused pill planner...Case Manager called with no response...will call again in the afternoon to update on patient status..." There was no documentation of a follow up by the agency staff about the nurse visit mentioned in the phone visit dated 10/23/2020. Review of the MR revealed no documentation the Case Manager and the physician were updated due to the patient stating he/she could not bring themselves to take the medication which could affect treatment effectiveness and require a change to the POC. Review of the SNV dated 11/5/2020 revealed documentation of "...patient continues to refuse medication reminders such as pill planner and states that he/she just isn't able to do it because his/her will is not strong enough. Case Manager...called and formed (informed) of patient status and refusal to follow suggested medication helpers and reminders. Case Manager and patient informed that patient may be discharged soon if nursing cannot provide another skill that patient is acceptable to..." There was no documentation the physician was notified of the patient's statement of his/her will not being strong enough and no documentation of discussion of other interventions to aid patient's ability to take his/her medications correctly with the Case Manager and/or physician. Review of the RN Discharge from Agency note dated 11/20/2020 revealed documentation of an ER visit without admission since the last agency visit for "improper medication administration..." Review of the Discharge Summary dated 11/20/2020 revealed documentation of the reason for discharge as "patient refusal to follow physician plan of care and therefore is not able to meet goals..." Review of the MR revealed there was no documentation of a MSW and/or MHN (Mental Health Nurse) referral. An interview was conducted on 3/17/21 at 12:44 PM with Employee Identifier (EI) # 6, Licensed Practical Nurse, who provided care to MR # 6. EI # 6 was asked if he/she recalled what interventions were performed to assist the patient with being complaint with medications. EI # 6 stated, "...we gave him/her a med (medication) planner to help." EI # 6 was asked if the agency staff attempted any other interventions to aid medication compliance. EI # 6 stated, "not that I remember." EI # 6 was asked if he/she felt there was any other interventions the agency could have attempted to aid the patient's medication noncompliance prior to discharge. EI # 6 stated, "adding the visits for the weekend...If it was an option to do more visits even if it was not billed for might have helped..." An interview was conducted on 3/18/21 at 10:27 AM with EI # 2, Area Vice President of Clinical Practice, who confirmed the only documented nursing intervention attempted to aid patient in taking his/her medication correctly was the medication planner. EI # 2 also confirmed there was no documentation the physician was notified of the patient's statement regarding the reason he/she was unable to take medication and follow the ordered POC. EI # 2 confirmed there was no documentation if a nurse other than the agency nurse visited the patient or any coordination of care occurred with an outside nurse. EI # 2 was asked if the agency had MSW and/or MHN coverage during the time of the patient's episode of care. EI # 2 verbalized the agency did not have a MSW or MHN on staff and would most likely refer the patient to another agency or have another branch of the agency provide the MSW and/or MHN services if ordered. EI # 2 verbalized there was no documentation MR # 6 was transferred to another agency following discharge and no documentation of an MSW and/or MHN referral.

Assure implementation of plan of care CFR(s): 484.105(c)(5) Assuring the development, implementation, and updates of the individualized plan of care. This ELEMENT is not met as evidenced by: Based on Medical Record (MR) reviews, agency policy and procedure, and interview with staff, it was determined the agency Clinical Manager failed to assure the development, implementation and update of the individualized plan of care for the patient, which affected MR # 3. This did affect 1 of 1 MR reviewed receiving aide services and had the potential to negatively affect all patient's served by the agency. Policy: TX-002 Subject: Coordination of Care Revised: 4/2019 Purpose: The patient's care and services will be coordinated among staff and branches. To avoid duplication of services. To coordinate scheduling when possible. To utilize/recommend appropriate internal and external resources as needed throughout the length of service. To ensure consistent documentation, communication, coordination, and retrieval of significant administrative and patient/family information. Regulatory Guidance: ...(c)...Review and revision of the plan of care. The individualized plan of care must be reviewed and revised by the physician who is responsible for the home health plan of care and the HHA (Home Health Agency) as frequently as the patient's condition or needs require... beginning with the start of care date. The HHA must promptly alert the relevant physician(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. ...(d)...Coordination of care. The HHA must...Integrate orders from all physicians involved in the plan of care to assure the coordination of all services and interventions provided to the patient. Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. Coordinate care delivery to meet the patient's needs and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities... Procedure: ...The Clinical Manager/designee is assigned to supervise and coordinate care for a patient: a. Has the primary responsibility to notify the attending physician and other agency staff of any significant changes in the patient's status; b. Assures the communication with all physicians involved in the plan of care; c. Manages and oversees coordination/integration of care and services by all disciplines to meet the patient's needs and identify factors that could affect patient safety and treatment effectiveness; and d. Notifies the patient, representative (if any) and caregivers as appropriate in coordination of care activities. 4. Relevant physicians are notified promptly of any changes in the patient's...needs that suggest ...outcomes are not being achieved and/or that the plan of care should be altered. The Plan of Care is appropriately revised/updated to reflect current information concerning the patient's measurable outcomes and goals. ...6. The agency manages the scheduling of patients taking into consideration the type of services that are being provided on a given day. 7. The HHA must provide the patient and caregiver with a copy of written instruction outlining the following: a. The agency must provide the patient and caregiver with the most current written visit schedule... ...c. Visit schedules are coordinated whenever possible. Patient's are notified of significant changes in schedule prior to scheduled visit time... 10. Patient care will not be interrupted due to staff absences. DOO (Director of Operations) or designee will ensure appropriate staff assignment and coverage. Patient care and services may be coordinated among staff and branches within the provider coverage area. 11. In the event an ordered service cannot be performed, the physician shall be notified and new orders obtained as indicated. The patient will be referred to another provider accordingly... 19. A missed visit communication note is completed when a home care visit is unable to be completed as scheduled and can not be rescheduled within the patient's Medicare treatment week. a. The physician will be notified... 1. MR # 3 was admitted to the agency on 10/15/2020 with diagnosis including Chronic Obstructive Pulmonary Disease, Unspecified, Other Symptoms and Signs with Cognitive Functions and Awareness, Lymphedema, Not Elsewhere Classified and Chronic Kidney Disease, Stage 1-4/Unspecified Chronic Kidney. Review of the Physician Order dated 11/23/2020 revealed Home Health Aide (HHA) to visit 2WK1 (two times per week time one week), 1WK1 for bathing/personal care to begin week of 11/30/2020. Review of the Episode Detail Report dated 1/7/2021 revealed a HHA visit was not made by the HHA the week of 12/10/2020. Further review of the Episode Detail Report dated 1/7/2021 revealed, the following: "HHA that was hired did not see patients after training. He/she dropped his/her tablet off after hours and did not give a notice that he/she was not going to return. Currently did not have a HHA to make the visits up. Faxed communication to MD on 1/7/2021." An interview conducted on 3/18/2021 at 10:18 AM with EI # 2, Area Vice President of Clinical Practice confirmed 3 HHA visits were missed and there were no attempts made to reassign the missed visits to another HHA or a nurse and no attempts were made to reschedule the missed visits to another HHA or nurse. EI # 2 confirmed the Physician was not notified of the missed visits or the agency's inability to complete the HHA plan of care until 28 days later.