Every finding on record at Clayview Home Health Services, Inc

The Emergency Preparedness regulations were reviewed as part of the Medicare recertification survey completed on 05/20/2026. During the survey it was determined the home health provider is in compliance with the requirements of 42 CFR 484.102 Condition of Participation: Emergency Preparedness for Home Health Providers.

A partial extended survey for Medicare recertification for the home health provider was completed on 05/20/2026. The provider had three current patients.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to ensure the registered nurse (RN) completed the initial assessment within 48 hours of the patient's referral or return home in, but not limited to, one of five full records reviewed (Record/Patient #1). This deficient practice has the potential to affect all patients served by the provider. Findings included: Review of the provider's policy titled, "Initial/Comprehensive Assessment," dated reviewed/revised 09/2025, showed in part, an RN, physical therapist (PT), or speech/language pathologist (SLP) must conduct the initial assessment within 48 hours of referral, within 48 hours of the patient’s return home, or on the physician-ordered start of care (SOC) date. RECORD/PATIENT #1: Review of the clinical record showed the patient was admitted to home health services on 04/27/2026 with a primary diagnosis of arthritis (a common, often chronic condition, characterized by inflammation, pain, and stiffness in one or more joints) of multiple sites. The patient lived alone in an apartment building. Review of the clinical record showed: -A referral dated 04/24/2026 for PT to evaluate and treat. - An OASIS (Outcome and Assessment Information Set; a standardized data collection tool) SOC assessment dated 04/27/2026 (72 hours later); and - A communication noted dated 04/27/2026 (72 hours after the referral was received) that showed: “This is to notify you that your referred patient to our agency (provider) refused to be seen within 48 hours of receiving the referral order. The patient declined the scheduled Friday visit and refused weekend visit availability. (There failed to be any documentation of the date that the patient was contacted to schedule the initial visit.) During an interview on 05/19/2026 at 4:20 PM the administrator stated that initial assessments were completed within 48 hours of the referral unless the patient requested a later date and, if so, the request would be documented, and the physician would be notified. During an interview on 05/20/2026 at 2:43 PM the administrator stated that: - When they entered the patient in the electronic medical record (EMR), that was the date that showed on the note and the EMR would not let them change the date; and - He/she would have to work on the “glitch” in the EMR, dating the documentation so it would be correct when a patient requested a late SOC.

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 policy review, record review, observation, and interview, the home health provider failed to ensure that all medications the patient was taking were current in one of two home visit observation records reviewed (Record/Patient #1). This deficient practice has the potential to affect all the patients served by the provider. Findings included: Review of the provider’s policy titled, “Drug Regimen Teaching,” dated reviewed/revised 09/2025, showed in part: -Policy: To ensure that clinicians instructed/reviewed with the patient/caregiver about how to manage medication effectively and safely; and - A drug review was to be completed at the time of admission. It would include all medications, prescribed and over the counter, the patient was currently taking and was to be included on the plan of care (POC). Review of the provider’s undated policy titled, “Medication Teaching,” showed in part: - A complete medication reconciliation would be performed at admission, resumption of care, recertification, and whenever changes occur; and - Discrepancies shall be clarified with physician and documented in the clinical record. RECORD/PATIENT #1: Review of the clinical record showed the patient was admitted to home health services on 04/27/2026 with a primary diagnosis of arthritis (a common, often chronic condition, characterized by inflammation, pain, and stiffness in one or more joints) of multiple sites. The patient lived alone in an apartment building. Review of a referral with a fax cover sheet dated 04/24/2026, showed under medications: Not taking amiodarone hydrochloride (HCl) 200 milligram (mg) one tablet daily (used for heart rhythm abnormalities). Linzess (used to treat irritable bowel syndrome) failed to be listed. Review of an OASIS (Outcome and Assessment Information Set; a standardized data collection tool) start of care (SOC) assessment dated 04/27/2026, showed: - Item M2001 marked 0 = no medication issues found during review; and - Page 32 of 35 listed amiodarone HCl 200 mg one tablet daily, and it failed to show Linzess 290 microgram (mcg) daily. Review of the initial POC, dated 04/27/2026 to 06/25/2026, showed Amiodarone HCl 200 mg one tablet daily listed and it failed to show Linzess 290 mcg. Observation and interview on 05/19/2026 at 1:48 PM showed the following discrepancies between the provider's current medication profile and the patient's home medication bottles: - The provider’s current medication profile showed amiodarone HCl 200mg one tablet daily. The patient stated that he/she did not take this medication and had not since admission to home health, “Maybe since back in January”; and - The provider’s current medication profile failed to show Linzess 290 mcg daily. The patient stated that he/she did take the Linzess daily and “had for a long time.” (The fill date on the bottle showed 02/02/2026.) During an interview on 05/20/2026 at 2:43 PM, the administrator stated that: - The patient should have been taking what the medication profile showed; and - Sometimes the patient did not tell the provider of changes.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the provider failed to ensure that each patient's written individualized plan of care included the frequency and duration of visits to be made, patient-specific interventions and education, measurable outcomes and goals identified in the comprehensive assessment, and all safety measures regarding high-risk medications in, but not limited to, one of five full records reviewed (Record/Patient #1). This deficient practice has the potential to affect all the patients served by the provider. Review of the provider’s undated policy titled, “Plan of Care (POC),” showed in part: - “Named provider” would establish, implement, and maintain an individualized written POC for each patient receiving home health services. The POC would be developed in collaboration with the physician or allowed practitioner and reflect patient-specific needs to ensure safe and effective care; - The POC would be developed based on the comprehensive assessment; and - The POC would include diagnoses, mental and functional status, medications and treatments, measurable goals, frequency and duration of services, rehabilitation potential if applicable, and discharge planning. Review of the provider’s undated policy titled, “Medication Teaching,” showed in part: - “Named Provider” would provide medication education to patients and caregivers to promote safe medication administration, prevent adverse drug effects, and ensure compliance with physician orders and regulatory requirements; and - Medication education would include drug name, purpose, dosage, route, frequency, potential side effects, adverse reactions, drug interactions, storage requirements, and when to notify the physician. High-risk medications would receive additional focused teaching; special attention would be given to anticoagulants (medication that prevents blood from clotting too easily), insulin (injectable medication used to lower blood sugar), opioids (medication used for moderate to severe pain), cardiac (heart) medications, and other high-risk drugs. Patients would be educated to monitor parameters and signs of complications. RECORD/PATIENT #1: Review of the clinical record showed the patient was admitted to home health services on 04/27/2026 with a primary diagnosis of arthritis (a common, often chronic condition, characterized by inflammation, pain, and stiffness in one or more joints) of multiple sites. The patient lived alone in an apartment building. Review of an OASIS (Outcome and Assessment Information Set; a standardized data collection tool) start of care (SOC) assessment dated 04/27/2026 showed item M2010 (Has the patient/caregiver received instructions on special precautions for all high-risk medications such as hypoglycemics (medication that lowers blood sugar levels), anticoagulants (medication that thins the blood), and how and when to report problems that may occur? Coded as one- yes. Review of the physical therapy (PT) evaluation note that was sent to the physician for signature, dated 04/28/2026, showed: visit frequency and duration was one time a week for one week, then two times a week for three weeks. Planned intervention: therapeutic exercises, neuromuscular reeducation, gait training, balance training, and home exercise program. (This information failed to be included on the initial POC). Review of the initial POC, dated 04/27/2026 to 06/25/2026 showed: - Xarelto 20mg (milligrams) one tablet daily (medication that thins the blood); - Case Summary: Patient admitted to home health services with diagnosis including arthritis, generalized pain, and weakness resulting in decreased mobility, reduced endurance, impaired balance, and increased fall risk within the home environment. Patients were referred for PT services to address strength deficits, gait instability, functional mobility limitations, pain management, and safety with daily activities; - “Therapy would follow through with patient. Order was for therapy care only. PT to evaluate and treat”; - PT goals: Patient would demonstrate ability to follow home exercise program by evaluation; - See therapy care plan for care goals; and - The initial POC failed to include patient-specific PT interventions and education, measurable outcomes and goals, and the PT visit frequency and duration; and - The POC failed to include specific safety measures regarding high-risk medications (Xarelto). During an interview on 05/19/2026 at 4:20 PM, the administrator stated that PT’s evaluation is their POC and the physician signs it. During an interview on 05/20/2026 at 10:23 AM, the administrator stated that: - It (high risk medication teaching) was marked on the OASIS SOC note, but did not pull over to the POC like it was supposed to; - He/she was going to call the electronic medical record (EMR) and find out why; - He/she always taught about high-risk medications, but it did not show on the POC; and - It may have been time to change EMRs. During an interview on 05/20/2026 at 2:43 PM, the administrator stated that he/she: - Thought the signed PT evaluation was the POC; and - Already started to fix the high-risk medication issue on the POC.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to ensure skilled professional services were provided in an acceptable manner and as ordered by the physician in one of five full records reviewed (Record/Patient #4). This deficient practice has the potential to affect all patients on service with the home health provider. Review of the provider’s policy titled, “Coordination of Patient Care,” revised 09/2025, showed in part: - The provider must 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; and - Coordination of providers internal resources includes assuring all involved staff members are aware of patient’s plan of care (POC). Findings included: RECORD/PATIENT #4: Review of the clinical record showed the patient was admitted to home health services on 03/17/2026 with a primary diagnosis of hypertensive urgency (occurs when blood pressure is severely elevated but there is no evidence of acute organ damage), adult failure to thrive (unexplained loss of appetite, weight loss, cognitive and functional decline, and social isolation, complicated by multiple medical comorbidities and psychiatric factors), and dementia without behavioral disturbance (decline in mental capacity). The patient lived with his/her spouse. Review of the hospital discharge orders dated 03/15/2026, showed occupational therapy (OT) for evaluation and treat for safety with ADLs (activities of daily living) /IADLs (instrumental activities of daily living). Review of an OASIS (Outcome and Assessment Information Set; a standardized data collection tool) start of care (SOC) assessment dated 03/17/2026 showed: - Fall injuries in the past six months, interventions planned: physical therapy (PT) box checked yes, OT box checked yes; - Orders for discipline and treatments: OT frequency per evaluation; and - Goals/Rehabilitation potential/discharge plans: OT - to demonstrate ability to follow home exercise program by (date) per evaluation inserted. Review of the initial POC, dated 03/17/2026 to 05/15/2026 showed: Orders for disciplines and treatments – OT per evaluation. Review of the communication note dated 03/18/2026 showed this is to inform you that there will be a delay in initiating OT services for the patient referred to the provider on 03/15/2026 and OT services are now scheduled to begin on 03/25/2026. Review of the record failed to show an OT evaluation. Review of the home health change of care notice showed: - Your home health care is changing. Starting on 03/26/2026 your home health provider will change the items/services listed below; - What items/services are changing? All home health services; - Reason for change – Insurance denies; and - Mailed to the patient 03/27/2026. During an interview on 05/20/2026 at 3:00 PM, the administrator stated that, when an order for an evaluation is received, the evaluation should be completed as ordered.

An extended survey for Medicare certification for Clayview Home Health Services, Inc was completed on 05/18/2023. The home health provider had five current patients. Ten (10) condition-level deficiencies were identified during the survey. Condition level deficiencies were identified at: §484.50 Condition of Participation: Patient Rights; §484.55 Condition of Participation: Comprehensive Assessment of Patients; §484.58 Condition of Participation: Discharge planning; §484.60 Condition of Participation: Care Planning, Coordination and Quality of Care; §484.65 Condition of Participation: Quality Assessment and Performance Improvement; §484.70 Condition of Participation: Infection Control; §484.75 Condition of Participation: Skilled Professional Services; §484.105 Condition of Participation: Organization and Administration of Services; §484.110 Condition of Participation: Clinical Records; The Emergency Preparedness regulations were reviewed as part of the Medicare certification survey completed on 05/19/2023; and One condition level deficiency was identified at §484.102 Condition of Participation: Emergency Preparedness for Home Health Agencies. A home health provider found out of compliance with any Condition of Participation evaluated as part of a standard survey may not train or competency evaluate their home health aides for a period of two (2) years following the date of this survey. A deficiency has been cited at §484.80(f) (3) -see Tag G788.

Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.542, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms "facility" or "facilities" in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This CONDITION is not met as evidenced by: Based on review of the home health provider’s Emergency Preparedness Plan (EP) and interview, the provider failed to establish an emergency preparedness program to meet the federal, state, and local emergency preparedness program requirements. The emergency preparedness program must include, but not limited to, the following elements: - The provider must develop and maintain an emergency preparedness plan that must be reviewed and updated at least every two (2) years (E0004); - Be based on and include a documented a facility based and community based risk assessment, utilizing an all-hazard approach assessment and include strategies for addressing emergency events identified by the risk assessment (E006); - Include the types of services the hospice would be able to provide in an emergency (E0007); - Develop emergency preparedness policies and procedures that include a plan for the agency patients during a natural or man-made disaster and include the individual plan for each patient in the comprehensive patient assessment (E0017); - Include procedures to inform State and local emergency preparedness officials about HHA patients in need of evacuation from their residences at any time due to an emergency situation based on the patient’s medical and psychiatric condition and home environment (E0019); - Develop emergency preparedness policies and procedures that address the procedures to follow up with on-duty staff and patients to determine services that are needed in the event there is an interruption in services during or due to an emergency; and that the agency must inform State and local officials of any on-duty staff or patients they are unable to contact (E-0021); - Revision and update of the written emergency communication plan at least every two years (E0029); - Names and contact information for staff, entities providing services under arrangement, patients’ physicians, and volunteers (E0030); - Ensure contact information was included and updated for federal, tribal, or other sources of assistance. (E0031); - Ensure that emergency preparedness training was provided every two years to all existing employees, and individuals providing services under arrangement (E0037); and - Conduct exercises (full-scale exercises/tabletop exercises) to test the emergency plan and analyze, maintain documentation of the exercise and revise as needed at least annually (E-0039). The cumulative effect of this deficient practice has the potential to affect the quality of care and safety of all agency patients.

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on policy review, review of the home health provider’s Emergency Preparedness (EP) Plan, and interview, the provider failed to review and update their EP plan every two years. This deficient practice has the potential to adversely affect all the patients served by the provider in the event of an emergency. Findings included: Review of the provider’s undated policy titled, “Emergency Disaster Plan,” showed: - To provide comprehensive preparation and successfully enable the shortest possible recovery time, whether in an emergency or disaster; and - A comprehensive emergency plan is prepared and updated annually. Review of the provider’s EP showed the plan had not been updated since 04/13/2020. During an interview on 05/18/2022 at 1:00 PM, the office manager, when asked if there were any reviews/updates since 04/13/2020, stated that was all she/he had.

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on review of the home health provider’s Emergency Preparedness (EP) Plan, and interview, the provider failed to document an all hazards risk assessment to address emergency events identified by the risk assessment. This deficient practice has the potential to adversely affect all the patients served by the provider in the event of an emergency. Findings included: Review of the provider’s undated emergency disaster plan showed it failed to contain the need for a facility-based and community risk assessment, utilizing an all hazards approach. Review of the provider’s EP showed it failed to contain an all hazards risk assessment. During an interview on 05/18/2022 at 1:00PM the office manager stated when asked if there was any documentation of an all hazards risk assessment he/she stated that was all she/he had. During an interview on 05/17/2023 at 2:15 PM, the administrator stated that they do not have documentation of all hazard risks..

EP Program Patient Population CFR(s): 484.102(a)(3) §403.748(a)(3), §416.54(a)(3), §418.113(a)(3), §441.184(a)(3), §460.84(a)(3), §482.15(a)(3), §483.73(a)(3), §483.475(a)(3), §484.102(a)(3), §485.68(a)(3), §485.542(a)(3), §485.625(a)(3), §485.727(a)(3), §485.920(a)(3), §491.12(a)(3), §494.62(a)(3). [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (3) Address [patient/client] population, including, but not limited to, persons at-risk; the type of services the [facility] has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.** *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do all of the following: (3) Address resident population, including, but not limited to, persons at-risk; the type of services the LTC facility has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. *NOTE: ["Persons at risk" does not apply to: ASC, hospice, PACE, HHA, CORF, CMCH, RHC/FQHC, or ESRD facilities.] This STANDARD is not met as evidenced by: Based on policy review, and review of the home health provider's Emergency Preparedness (EP) Plan, the provider failed to include the types of services the hospice would be able to provide in an emergency. This deficient practice has the potential to affect all patients served by the provider. Findings included: Review of the provider’s undated policy titled, "Emergency Disaster Plan,” showed: - The purpose of the policy was to provide comprehensive preparation and successfully enable the shortest possible recovery time, whether inn an emergency or disaster; - To provide for the coordination of activities relating to emergency preparedness with public and private agencies in the community; and -To provide agency policy in accordance with state policy. A review of the provider's emergency preparedness plan failed to include what services/assistance the hospice would be able to provide in the event of an emergency.

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure each patient had an individualized emergency plan documented as part of the patient's comprehensive assessment in five of six records reviewed (Records/Patients #1, #2 #3, #4, and #5). Findings included: Review of the clinical records showed that the comprehensive assessments completed for record/patient #1 on 04/04/2023, record/patient #2 on 03/16/20023, record/patient #3 on 05/10/2023, record/patient #4 on 03/08/2023, and record/patient #5 on 04/03/2023 failed to include documentation for emergency planning and individualized emergency plans (page 4 of 35 in the comprehensive assessment). During an interview on 05/17/2023 at 2:15 PM, the administrator stated that he/she did not know why the patient's emergency plan was not showing up. No further information was provided.

Homebound HHA/Hospice Inform EP Officials CFR(s): 484.102(b)(2) §418.113(b)(2), §460.84(b)(4), §484.102(b)(2) [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] *[For homebound Hospice at §418.113(b)(2), PACE at §460.84(b)(4), and HHAs at §484.102(b)(2):] The procedures to inform State and local emergency preparedness officials about [homebound Hospice, PACE or HHA] patients in need of evacuation from their residences at any time due to an emergency situation based on the patient's medical and psychiatric condition and home environment. This STANDARD is not met as evidenced by: Based on review of the provider's Emergency Preparedness (EP) binder, and interview, the agency failed to include a procedure for informing state and local officials of patients in need of evacuation during an emergency. This deficient practice has the potential to adversely affect the safety of all patients during an emergency. Findings included: Review of the provider’s EP binder failed to show evidence of a procedure to ensure state and local officials are contacted in the event a patient needs evacuation during an emergency, including when and how this information is communicated to the emergency officials and also include clinical care needed for these patients. During an interview on 05/18/2023 at 1:00 PM, the office manager stated that this is all they have (while pointing to emergency preparedness plan). During an interview on 05/17/2023 at 2:15 PM, the office manager stated that he/she was the one responsible for coordinating annual training with local officials. He/she would be at home during an emergency, and it was not the agency's responsibility to follow up with patients. The patients physician and dentist see the patients as well, so they should have to call them as well.

HHA- Procedures for Follow up Staff/Pts. CFR(s): 484.102(b)(3) §484.102(b)(3) Condition of Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (3) The procedures to follow up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency. The HHA must inform State and local officials of any on-duty staff or patients that they are unable to contact. This STANDARD is not met as evidenced by: Based on policy review, review of the Emergency Preparedness (EP) Plan, and interview the home health provider failed to comply with all federal, state, and local emergency preparedness requirements when the agency failed to establish, and maintain a program that addressed procedures to follow up with on-duty staff, and patients to determine services that are needed. This deficient practice has the potential to affect the health, safety, and well-being of all patients and staff of the provider. Findings included: Review of the provider's undated policy titled, "Emergency Disaster Plan" showed: - The policy was provide for rapid and orderly rehabilitation of persons, and for the restoration of services and properties; and - To prepare for prompt and efficient rescue, care and treatment of threatened or affected persons. Review of the EP plan failed to show procedures addressing follow up with on-duty staff and patients to determine services that are needed. During an interview on 05/18/2023 at 1:00 PM, the office manager stated that this is all they have (while pointing to emergency preparedness plan). During an interview on 05/17/2023 at 2:15 PM, the office manager stated that he/she was the one responsible for coordinating annual training with local officials. He/she would be at home during an emergency, and it was not the agency's responsibility to follow up with patients. The patients physician and dentist see the patients as well, so they should have to call them as well.

Development of Communication Plan CFR(s): 484.102(c) §403.748(c), §416.54(c), §418.113(c), §441.184(c), §460.84(c), §482.15(c), §483.73(c), §483.475(c), §484.102(c), §485.68(c), §485.542(c), §485.625(c), §485.727(c), §485.920(c), §486.360(c), §491.12(c), §494.62(c). (c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. This STANDARD is not met as evidenced by: Based on policy review, and review of the home health provider’s Emergency Preparedness (EP) Plan, the agency failed to comply with all federal, state, and local emergency preparedness requirements when the provider failed to review, and update a written emergency communication plan at least every two years. This deficient practice has the potential to affect the health, safety, and well-being of all patients and staff of the provider. Findings included: Review of the provider's undated policy titled, "Emergency Disaster Plan" showed: - The purpose was to provide for the coordination of activities relating to emergency preparedness with public and private agencies in the community; and - A comprehensive emergency plan is prepared and updated annually. Review of the provider's EP failed to show a written communication plan was reviewed and updated at least every two years. During an interview on 05/17/2023 at 2:15 PM, the office manager stated that he/she would be a t home during an emergency, and it was not the agency's responsibility to follow up with patients. The patients physician and dentist see the patients as well so they have to call them to then.

Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: Based on review of the home health provider's Emergency Preparedness (EP) binder, and interview, the provider failed to ensure names, and contact information for staff, entities providing services under arrangement, patient's physicians, and volunteers were included in the EP plan. This deficient practice has the potential to adversely affect the care and safety of all patients served by the provider during an emergency. Findings included: Review of the provider's EP binder showed: - The names and contact information for the provider’s administrator, alternate administrator, office manager, and one Register Nurse; - It failed to contain names and contact information for entities providing services under arrangement, patient's physicians, and volunteers. During an interview on 05/18/2023 at 1:00 PM, the office manager stated that this is all they have (while pointing to emergency preparedness plan). During an interview on 05/17/2023 at 2:15 PM, the office manager stated that he/she would be a t home during an emergency, and it was not the agency's responsibility to follow up with patients. The patients physician and dentist see the patients as well so they have to call them to then.

Emergency Officials Contact Information CFR(s): 484.102(c)(2) §403.748(c)(2), §416.54(c)(2), §418.113(c)(2), §441.184(c)(2), §460.84(c)(2), §482.15(c)(2), §483.73(c)(2), §483.475(c)(2), §484.102(c)(2), §485.68(c)(2), §485.542(c)(2), §485.625(c)(2), §485.727(c)(2), §485.920(c)(2), §486.360(c)(2), §491.12(c)(2), §494.62(c)(2). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This STANDARD is not met as evidenced by: Based on review of the home health provider's Emergency Preparedness (EP) binder, and interview, the provider failed to ensure contact information was included, and updated for federal, tribal, or other sources of assistance. This deficient practice has the potential to adversely affect the care and safety of all patients served by the provider during an emergency. Findings included: Review of the provider's EP binder showed no contact information for federal, tribal, or other sources of assistance. During an interview on 05/18/2023 at 1:00 PM, the office manager stated that this is all they have (while pointing to emergency preparedness plan). During an interview on 05/17/2023 at 2:15 PM, the office manager stated that he/she would be a t home during an emergency, and it was not the agency's responsibility to follow up with patients. The patients physician and dentist see the patients as well so they have to call them to then.

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on employee file review and interview, the provider failed to ensure that emergency preparedness training was provided every two years to all existing employees, and individuals providing services under arrangement, in one of four employee files reviewed (E-1). This deficient practice has the potential to impact the employee's ability to maintain employee and patient safety in the event of an emergency. Findings included: E-1: Review of the employee file showed the last documentation present to confirm that the employee had emergency preparedness training was dated 07/19/2019. During an interview on 05/18/23 at 1:00 PM the office manager stated that the employee file did not have any more training documentation .

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on policy review, review of the home health provider’s Emergency Preparedness (EP) plan, and interview, the home health provider failed to conduct an annual, individual, facility-based functional exercise to test the emergency plan annually, and analyze the agency's response, and revise the agency's emergency plan as needed. This deficient practice has the potential to adversely affect the care and safety of all patients served by the provider during an emergency. Findings included: Review of the provider's undated policy titled, "Emergency Disaster Plan" showed: - The purpose was to provide for the coordination of activities relating to emergency preparedness with public and private agencies in the community; and - A comprehensive emergency plan is prepared and updated annually. Review of the provider's EP binder failed to show documentation of an annual, individual, facility-based functional exercise. Review of the provider's EP binder showed the following tabletop exercises only: - Coronavirus Disease 2019 (COVID-19) Pandemic with an exercise date of 10/14/2021; and - Heart of Winter a Home Healthcare tabletop exercise dated May 22, 2022. Further review of the EP binder failed to show any other training or drills provided for staff. During an interview on 05/18/2023 at 1:00PM the clinical manager stated that the provider: - Did have the fire department come this year to the office, but I didn’t contact anyone else because I am the only one here; - We have never done a drill where we call all the staff, that’s just dumb; and - I probably wouldn’t be here anyway. I would be at home. .

Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on policy review, current patient rights information, and interview, the home health provider failed to promote and protect the following patient rights: - Provide contact information for the home health agency (HHA) administrator, that included the administrator's name (G414); - Make complaints to the home health provider regarding care that fails to be furnished (G432); - Receive proper written notice, in advance of the home health provider terminating on-going care (G442); - Be advised of the state toll free home health telephone hotline hours of operation (G444); and - The home health provider may only transfer or discharge the patient from home health services if: * The transfer or discharge is necessary for the patient’s welfare because the home health provider and physician who is responsible for the home health plan of care agrees the home health agency meet the patient’s needs based on acuity. The home health provider must provide a safe and appropriate transfer to other care entities when the needs of the patient exceed the home health providers capabilities (G454). The cumulative effect of these deficient practices resulted in the agency's inability to ensure that all patients and/or representatives rights were promoted and protected. .

HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator's name, business address, and business phone number in order to receive complaints. This ELEMENT is not met as evidenced by: Based on policy review, record review, home observation visit, and interview, the home health provider failed to provide contact information, that included the administrators name in order to receive complaints, in one of three home observation visits (Record/Patient #1). The deficiency has the potential to affect all patients on service with the agency. Findings included: Review of the home health provider's undated policy titled, "Rights of the Elderly," showed, in part: - An elderly individual may complain about the individuals care or treatment; - The person providing the service shall promptly respond to resolve the complaint; and - The person providing services may not discriminate or take other punitive action against an elderly individual who makes a complaint. Review of the home health provider's undated policy titled, "Complaint Process Policy," showed, in part: - All complaints may be directed to the Administrator or designee (policy failed to include the names of the administrator and/or designee); and - The investigation of the complaint will be initiated within 10 calendar days and resolved within 30 calendar days of receipt. RECORD/PATIENT #1: Review of the clinical record document, titled, "Patient Rights and the Rights of the Elderly," showed, in part: - I (patient) have received a copy of an explanation of my Patient Rights and the Rights of the Elderly, as appropriate; - I (patient) have been notified of my right to voice a complaint and may direct that complaint to the Department of Aging and Disability Services; - I (patient) may also direct a complaint to the Administrator or designee (The informed consent failed to include the names of the administrator and/or designee); - The investigation of the complaint will be initiated within 10 calendar days and resolved within 30 calendar days of receipt; and - Was signed and dated by the patient on 04/14/2023. Observation on, 05/17/2023, beginning at 9:00 AM, during the patient's home visit, showed: - The patient had a home folder that contained a medication list and visit schedule; and - The patient did not have an informed consent document that contained the administrator’s name in order to receive complaints. During an interview, on 05/17/2023, at the home observation visit, beginning at 9:00 AM, the patient stated that: - He/she has not had any complaints; and - He/she just contacts the nurse for any questions or concerns and does not need to contact the agency.

Make complaints to the HHA CFR(s): 484.50(c)(3) Make complaints to the HHA regarding treatment or care that is (or fails to be) furnished, and the lack of respect for property and/or person by anyone who is furnishing services on behalf of the HHA; This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to document concerns from a patient regarding abrupt discharge without notice in advance of terminating on-going care, in one of six full records reviewed (Record/Patient #6). The deficiency has the potential to affect all patients on service with the agency. Findings included: Review of the home health provider's undated policy titled, "Rights of the Elderly," showed, in part: - An elderly individual may complain about the individuals care or treatment; - The person providing the service shall promptly respond to resolve the complaint; and - The person providing services may not discriminate or take other punitive action against an elderly individual who makes a complaint. Review of the home health provider's informed consent document titled, "Patient Rights and the Rights of the Elderly," provided to the patient’s on admission, showed, in part: - I (patient) have received a copy of an explanation of my Patient Rights and the Rights of the Elderly, as appropriate; - I have been notified of my right to voice a complaint and may direct that complaint to the Department of Aging and Disability Services; - I may also direct a complaint to the Administrator of (named home health agency), or designee; and - The investigation of the complaint will be initiated within 10 calendar days and resolved within 30 calendar days of receipt. Review of the home health provider’s grievance log showed, no complaints had been recorded. RECORD/PATIENT #6: Review of the recertification visit, dated, 01/06/2023, at 11:00 AM, showed, in part: - Visit was completed by the administrator on, 01/06/2023, at 11:00 AM, for monthly catheter (a soft tube that is inserted into the bladder to drain urine) changes; and - The discharge plans section had, “Discharge at the end of the episode if patient is hospitalized,” selected. Review of the transfer documentation, dated 02/09/2023, showed, in part: - Transferred to an inpatient facility with discharge from the home health agency; - Inpatient facility had hospital selected; and - Transfer record failed to include documentation of communication with any hospital and/or inpatient facility (no record that the patient was hospitalized). Review of the discharge summary note, dated 02/09/2023, showed, in part: - Yes as per current plan of care, was selected for continuing care needs; - Yes, was selected for the patient having resources available to meet on-going needs; - Discharge/transfer instructions included, counseled to call agency for future home care needs (No documentation of who was counseled to call the agency for future home care needs); - Patient status at discharge/transfer, unstable health condition, patient has been admitted to the hospital, agency will not be taking patient back, was noted; - Summary of care provided, included, monthly urinary catheter change without complications. Patient transferred and discharged to hospital. Agency will no longer accept patient back until patient gets the rehabilitation needed to get patient to functional level status; - Yes, was selected for patient discharged unexpectedly; - Copy of summary sent to MD (medical doctor) with current PCP (primary care physician) was selected; and - No record of discharge/transfer summary sent to inpatient facility. During an interview, on 05/17/2023, beginning at 11:45 AM, the office manager stated that: - The patient was not in the hospital at the time of discharge; - Transfer and recertification documentation must have been a mistake; - The patient only had one episode and was discharged after the episode ended; - The patient called the home health agency mad that the agency would not pick the patient back up; and - The patient even filed an appeal with Medicare for the home health agency discharging the patient. During an interview, on 05/18/2023, beginning at 9:45 AM, the patient stated that: - He/she was not in the hospital at the time of discharge; - The nurse called and discharged him/her over the phone, saying that he/she had to be discharged due to not being cooperative; - The home health agency never provided him/her with written notice of services being terminated; - He/she complained to the nurse (administrator) about the office manager; and - He/she filed an appeal with Medicare. During an interview, on 05/18/2023, beginning at 11:55 AM, the administrator stated that: - The patient was mad that the agency wouldn’t pick the patient back up for services; - The complaint was not recorded in the home health agencies grievance log because the patient was already discharged at the time of the complaint; and - The home health agency only records complaints from active patients.

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 policy review, record review, and interview, the home health provider failed to provide written notice in advance of terminating on-going care to the patient, in one of two discharge records reviewed (Record/Patient #6). The deficiency has the potential to affect all patients on service with the agency. Findings included: Review of the home health provider's undated policy titled, "Rights of the Elderly," showed, in part; - A person providing services shall fully inform an elderly individual, in language that the individual can understand, of the individual’s total medical condition; and - Shall notify the individual whenever there is a significant change in the person’s medical condition. Review of the home health provider's undated policy titled, "Patient/Client Transfer, Discharge and Agency Dissolution," showed, in part; - The home health agency intending to transfer the patient will: * Provide written notification to the patient/client or the patient’s/client’s parent, family, Spouse, significant other or legal representative; and * Provide notice of transfer as required by state law; and - The home health agency will provide the Home Health Change of Care Notice (HHCCN) to inform a patient/client or their representative when the agency is discharging due to agency reasons. RECORD/PATIENT #6: Review of the clinical record failed to show: - Written notice provided to the patient in advance that home health services were being terminated; - Written notification provided to the patient and/or patient representative that the home health agency intended to transfer the patient (Required per the home health agencies policy); and - Transfer and/or discharge summary sent to the receiving facility. During an interview, on 05/18/2023, beginning at 9:45 AM, the patient stated that: - The nurse called and discharged him/her over the phone, saying that he/she had to be discharged due to not being cooperative; and - The home health agency never provided him/her with written notice of services being terminated. During an interview, on 05/18/2023, beginning at 11:55 AM, the administrator stated that: - The patient was not provided with written notice of transfer with discharge because the patient was in the hospital (No record that the patient was hospitalized); - No transfer and/or discharge summary was sent to the receiving facility because he/she did not know what facility the patient was in; and - He/she was informed by “someone” that the patient was in the hospital but he/she did not make any attempts to confirm or verify that the patient was hospitalized.

State toll free HH telephone hotline CFR(s): 484.50(c)(9) Be advised of the state toll free home health telephone hot line, its contact information, its hours of operation, and that its purpose is to receive complaints or questions about local HHAs. This ELEMENT is not met as evidenced by: Based on the home health provider’s admission folder and interview, the provider failed to provide written notice of the updated state toll free home health telephone hotline hours of operation (7:00 AM to 8:00 PM, seven days a week). This deficient practice has the potential to affect the rights of all the provider’s patients. Findings included: Review of the admission booklet, Patient Bill of Rights, showed: - The Missouri toll-free hotline, hours are 7AM [7:00 AM] to Midnight [12:00 AM], 7days per week; and - Its purpose for the receipt of complaints and questions regarding home health issues. During an interview conducted on 5/16/2023 at 11:00 A.M. the office manager stated he/she not aware the state hotline hours had changed.

HHA can no longer meet the patient's needs CFR(s): 484.50(d)(1) The transfer or discharge is necessary for the patient's welfare because the HHA and the physician or allowed practitioner, who is responsible for the home health plan of care agree that the HHA can no longer meet the patient's needs, based on the patient's acuity. The HHA must arrange a safe and appropriate transfer to other care entities when the needs of the patient exceed the HHA's capabilities; This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to arrange a safe and appropriate transfer to other care entity when the needs of the patient exceeded the HHA’s (home health agency) capabilities, in one of six full records reviewed (Record/Patient #6). The deficiency has the potential to affect all patients on service with the agency. Findings included: Review of the home health provider's undated policy titled, "Patient/Client Transfer, Discharge and Agency Dissolution," showed, in part; - If the transfer or discharge is necessary for the patient’s/client’s welfare because the agency and the physician who is responsible for the home health plan of care agree that the agency can no longer meet the patient’s/client’s needs, based on the patient’s/client’s acuity, the agency must arrange a safe and appropriate transfer to other care entities when the needs of the patient/client exceed the home health agency’s capabilities; - The HHA will assist the patient/client and family in choosing an alternative entity by identifying those entities in the area that may be able to meet the patient’s/client’s needs based on the acuity; - The HHA will contact the receiving agency or facility to advise them of the transfer or transfer and discharge, coordinate the transfer date and patient/client care, and establish any specific transfer conditions; and - If indicated, an order for MSW (medical social worker) intervention will be obtained with the transfer order or transfer and discharge order to facilitate the transfer. RECORD/PATIENT #6: Review of the recertification visit, dated, 01/06/2023, at 11:00 AM, showed, in part: - Visit was completed by the administrator, on 01/06/2023, at 11:00 AM, for monthly catheter (a soft tube that is inserted into the bladder to drain urine) changes; and - The discharge plans section had, “Discharge at the end of the episode if patient is hospitalized,” selected. Review the transfer documentation, dated, 02/09/2023, showed, in part: - Transferred to an inpatient facility with discharge from the home health agency; - Inpatient facility had hospital selected; and - Transfer record failed to include documentation of communication with receiving facility (The clinical record failed to show confirmation that the patient was hospitalized). Review of the discharge summary note, dated, 02/09/2023, showed, in part: - The patient had continuing care needs (Patient is bedbound, requires a lift to transfer from the bed, and has a foley catheter); - Yes, was selected for the patient having resources available to meet on-going needs (No documentation of what resources were available to meet on-going needs); - Discharge/transfer instructions included, counseled to call agency for future home care needs (No documentation of who was counseled to call the agency for future needs); - Patient status at discharge/transfer: unstable health condition. Patient has been admitted to the hospital. Agency will not be taking patient back (No documentation that the HHA arranged a safe and appropriate transfer and/or discharge to other healthcare entity); - Yes was selected for patient discharged unexpectedly; - Summary of care provided included, monthly foley catheter change without complications. Patient transferred and discharged to hospital. Agency will no longer accept patient back until patient gets the rehab needed to get patient to functional level status; and - No record of discharge/transfer summary sent to an inpatient facility. During an interview, on 05/18/2023, beginning at 9:45 AM, the patient stated that: - He/she was not in the hospital at the time of discharge; - The HHA just dropped him/her; - He/she was informed over the phone by the HHA that he/she was being discharged due to not being cooperative; and - His/her PCP (primary care provider) had to assist in finding another HHA to change his/her catheter. During an interview, on 05/18/2023, beginning at 11:55 AM, the administrator stated that: - The patient was not provided with written notice of transfer with discharge because the patient was in the hospital (No record that the patient was hospitalized); - No transfer and/or discharge summary was sent to the receiving facility because he/she did not know what facility the patient was in; and - He/she was informed by “someone” that the patient was in the hospital but he/she did not make any attempts to confirm or verify that the patient was hospitalized.

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on clinical record review, home visit observation, and interview, the agency failed to ensure that a complete and accurate patient specific comprehensive assessment was completed for each patient. The agency failed to: - The registered nurse must conduct the initial assessment visit to determine the immediate care and support needs of the patient. The initial assessment visit must be held either within, 48 hours of the referral, or within 48 hours of the patient’s return home, or on the physician-ordered start of care date (G514); - Ensure that the comprehensive assessment adequately reflected the patient's current health, psychosocial, functional, and cognitive status (G528); and - Ensure the performance of an accurate and ongoing drug regimen review that included all medications the patient was currently taking (G536). The cumulative effects of these deficient practices has the potential to effect all patients served by the home health agency. .

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to conduct the initial assessment of the patient within 48 hours of the referral to home care, or 48 hours after the patient's return home, or on the physician ordered start of care date, in one of six records reviewed (Record/Patient #5). This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the home health provider's undated policy titled, "Start of Care Comprehensive Assessment,” showed, in absence of a physician-specified start of care date order, the initial assessment visit and comprehensive assessment are conducted within 48 hours of the referral. RECORD/PATIENT #5: Review of the fax request for orders signed by the primary care physician, dated 03/31/2023 at 1:41 PM, showed home health nurse for wound care. Review of the comprehensive assessment, dated 04/3/2023, showed the patient was admitted to home health care on 04/03/2023 (three days after the referral for home health) and the date of the referral was 03/31/2023. The patient did not discharge from an inpatient facility. During an interview on 05/17/2023 at 9:21 AM, the office manager stated there were no physician orders for the late start of care on 04/03/2023.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to ensure the skilled clinician’s assessments of patients accurately reflected the patient’s current health status, in four of six full records reviewed (Records/Patients #1, #3, #4, and #6). This deficient practice has the potential to adversely affect the home health provider’s ability to ensure the accurate assessment of all patients served by the provider. Findings included: Review of the home health provider’s undated policy titled, “Policy 4.10: Start of Care Comprehensive Assessment,” showed: - A comprehensive assessment is conducted on all clients admitted into “named provider” no later than five calendar days after the start of care to identify the client’s medical, nursing, rehabilitative, social and discharge planning needs; - A comprehensive assessment is performed once the initial assessment determines that the “named provider” can meet the client’s critical needs and for Medicare clients the initial assessment determines eligibility for home health benefits, including homebound status; - The comprehensive assessment includes the required OASIS (Outcome and Assessment Information Set- An instrument/data collection tool used to collect and report assessment data by home health agencies) data items for the time point indicated and the following elements to allow the collection of pertinent data regarding the client, supportive assistance and the client’s environment; and - The following is the pertinent data assessed: * Clinical record items; * Demographics; * Patient history; * Living arrangements (safety needs and concerns); * Supportive assistance (willing and able caregivers); * Physical assessment (vital signs, weight, sensory, integumentary). Review of the home health provider’s undated policy titled, “Comprehensive Assessment Policy,” showed the comprehensive assessment must include: - Current health status, past medical history; - Current health status/problems; - Current functional status; and - Review of all medications including: * Adverse effects/drug reactions; * Ineffective drug therapy; * Side effects; *Significant drug interactions; * Duplicate drug therapy; and * Noncompliance drug therapy. RECORD/PATIENT #3: Review of the referral information showed a discharge summary with a discharge date of 05/09/2022 from a local LTAC (long term acute care) hospital with documentation of a left BKA (below knee amputation). Review of the comprehensive assessment dated 05/10/2022 showed: - Under the musculoskeletal section a box with amputation (where) left unmarked; - Under the functional limitations sections a box with amputation left unmarked; and - Patient history and diagnoses failed to show documentation of a left BKA. Review of the Initial POC (plan of care) dated 05/10/2022 to 07/08/2022 failed to show documentation of a diagnosis of left BKA, or any documentation indicating the patient had a left BKA. During an interview on 05/18/2023 at 12:24 PM the administrator stated that he/she would expect the comprehensive assessment to be accurate and a response marked in the amputation boxes and where (location of the amputation) documented. RECORD/PATIENT #1: Review of the start of care (SOC) comprehensive assessment, dated, 04/04/2023, at 11:45 PM, showed: - Emergency planning/fire safety was not addressed and the comment section was blank; - Nose section had WNL (within normal limits) selected (patient admitted with a primary diagnosis of acute rhinosinusitis-swelling/inflammation in the nasal and sinus tissue) - Genitourinary tract section had WNL selected (patient has a diagnosis of urge urinary incontinence- sudden urge to urinate and leaking may occur before getting to the bathroom); - Oxygen is selected (patient is not on oxygen); - Endocrine section has WNL selected (patient is a diabetic and is taking diabetic medications); - Nutritional requirement has regular diet (patient is a diabetic and has a recent history of uncontrolled diabetes); - (M1740) Cognitive, behavioral, and psychiatric symptoms, had impaired decision-making, failure to perform usual activities of daily living, inability to appropriately stop activities, and jeopardizes safety through actions, selected (further review of assessment documentation showed that patient is independent with activities of daily living); - (M1745) Frequency of disruptive behavior symptoms, had at least daily, selected (no documentation of safety interventions related to disruptive behavior); and - (M2010) Patient/caregiver high risk drug education had N/A (not applicable) selected (patient is taking high risk medications that include diabetic and anti-psychotic medications, as well as other medications that have major drug interaction risks when taken together). RECORD/PATIENT #6: Review of the SOC comprehensive assessment, dated, 11/11/2022, beginning at 4:17 PM, showed: - Significant past health history was marked with normal (patient has diagnosis of asthma and that was listed as an option to select, as well as, other health history); - Emergency planning/fire safety was not addressed and the comment section was blank (the patient was a paraplegic (paralysis of lower extremities), bed bound, required a lift assistive device to transfer out of bed, and lived alone); - Integumentary status section, had right and left heel blisters listed for other (no further documentation of assessment details of the blisters documented in this section); - Wound care performed, had N/A selected (SN visit summary had, blister care performed on both heels, SN to change x2 (two times) weekly); - Genitourinary tract section had WNL selected (patient has a foley catheter (soft tube inserted into the bladder to drain urine) for urination); - Respiratory status interventions and goals sections, both had, N/A marked (patient has a medical history of COPD (chronic obstructive pulmonary disease- a group of lung diseases that block airflow and make it difficult to breath), oxygen was selected, and no order for oxygen was found); - Elimination interventions and goals section, were left blank next to the foley catheter interventions and goals; - Skilled nurse visit summary had, educated on surgical wound care management, documented (no record found for a surgical wound); and - Durable medical equipment and supplies failed to include mechanical lift, foley catheter, and wound care supplies (the assessment showed the patient had a hospital bed listed under the musculoskeletal assessment section, mechanical lift, and wound care performed). During an interview on 05/17/2023, beginning at 10:10 AM, the administrator stated that: - He/she did not realize there were major drug interactions to report to the physician (report was faxed during this interview after administrator realized it was not faxed); - He/she charted endocrine section WNL in error and should have documentation related to diabetes; and - He/she is behind on documentation and was caught off guard because he/she thought that the agency was not supposed to have a survey until September. RECORD/PATIENT #4: Review of the comprehensive assessment dated 03/08/2023 at 2:30 PM showed: - (M1000) From which of the inpatient facilities was the patient discharged during the past 14 days was left unmarked (the patient was discharged from the hospital on 03/07/2023); - Emergency planning/fire safety was not addressed and the comment section was blank (the patient was a quadriplegic (paralysis of all four limbs) and bed bound); - (C0200) Repetition of three words was not assessed; - (C0300) Temporal orientation (orientation to year, month, and day) was not assessed; - (C0400) Recall was not assessed; - Cardiovascular (related to the heart and blood vessels) was not assessed; - Oxygen was marked and the patient was not on oxygen; - Nutritional risk showed regular high protein diet (the referral showed low fat/cholesterol, two gram sodium (heart healthy) diet; and - Durable medical equipment and supplies was left blank (the assessment showed the patient had a manual wheelchair, mechanical lift, and wound care supplies), .

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 policy review, record review, home visit observation, and interview, the home health provider failed to ensure a complete/accurate medication review, and/or update of the patient’s medications was completed, in three of six full records reviewed (Records/Patients #1, #3, and #6). This deficient practice has the potential to adversely affect accurate medication administration of all the patients served by the provider. Findings included: Review of the provider’s undated policy titled, “Policy 4.24: Drug Regimen Review and Medication Profile,” showed: - All comprehensive assessments include a review of all medications that the client is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects and drug interactions, duplicate drug therapy and noncompliance with drug therapy; - The initial drug regimen review begins during the first visit with documentation of all medications a client is taking on the medication profile, to include over-the-counter drugs and herbals; - The initial and updated medication profiles serves as documentation of medications to be recorded on the plan of care; - The clinician reports any suspected adverse effects, drug reactions, ineffective drug therapy, significant side effects and interaction, duplicate drug therapy and/or noncompliance with drug therapy to the physician immediately; - The medication profile is to be updated, reviewed, signed and dated at the minimum of every two months and with any new or changed medication order to include over the counter medications and herbals; - The clinician should clarify any medication uncertainties with the physician and document appropriately; - Verbal orders should be written for any new or changed medication given directly to the clinician from the physician or authorized physician staff member. New or changed medications given directly to the client should be documented on the daily visit note; and - The “named provider” medication profile is to be completed in its entirety, signed, and dated by the appropriate registered nurse. Review of the provider’s undated policy titled “Drug Profile Policy,” showed: - A review of all patient’s prescription and over the counter drugs, herbals remedies and other alternative treatments that could affect the patient’s profile must be documented and checked on admission and when changes in patient’s medications occur; - The review must include: * Effectiveness of drug therapy; * Drug side effects; * Actual or potential drug interactions; * Duplicate drug therapy; and * Drug therapy currently associated with lab monitoring. - Staff will check medications in the home on each visit to ensure they match the plan of care/medication profile in the clinical record; and - If there are changes, the physician will be notified of the change and physician response will be documented. The patient/caregiver will be notified of the physician’s response. RECORD/PATIENT #3: Review of the referral discharge medication list dated 05/09/2022 showed: - Acetaminophen 650mg (milligrams) every six hours prn (as needed) for pain (mild 1-4); - Ascorbic acid (vitamin c replacement) 500 mg daily; - Carvedilol (used to treat high blood pressure and heart failure) 12.5mg every 12 (twelve hours); - Polyethylene glycol (Miralax) (stool softener), 17g (grams) daily; - Senna docusate (combination stool softener and laxative) one tablet every twelve hours; and - Silver Sulfadiazine (used to prevent and treat wound infections) 1 application topically every shift. Review of the initial POC (plan of care) dated 05/10/2022 to 07/08/2022 showed: - 24 hour vitamin C (vitamin C replacement) 1000mg 1 tablet daily; - Carvedilol 12.5mg 1 tablet daily; - Miralax 17g as necessary; - Docusate sennosides 50mg-8.6mg oral daily; - Silver Sulfadiazine 10mg/1g 1% cream, topical daily; - Refresh optive (eye lubricant drops) 0.5%-0.9% 1-2 drops ophthalmic (eye) as needed (failed to be listed on referral); - Nitrofurantoin macrocrystals (used to prevent and treat urinary tract infections) 100 mg two capsules daily until finished (not on referral); - Omega XL (joint health supplement) capsule daily (not on referral; and - Lactobacillus acidophilus (a supplement used to promote the growth of good bacteria to improve digestive health) one capsule daily (not on referral). Review of the SOC (start of care) OASIS (Outcome and assessment information set- a standardized assessment tool), dated 05/09/2023 showed ItemM2001 showed Drug regimen review coded 0 = No issues found during review. Further review of the clinical record failed to show physician orders or documentation of these medication discrepancies clarified with the physician. During an interview on 05/18/2023 at 12:24 PM the administrator stated that he/she would expect the discrepancies from the referral/discharge medication list compared with the medications the patient is taking at start of care be clarified with the physician. RECORD/PATIENT #1: Review of the referral record, dated, 04/03/2023, showed, a medication list with: - Atorvastatin (treats high cholesterol) 10 mg (milligram) oral tablet, take 1 (one) tablet by mouth every night at bedtime; - Gabapentin (treats nerve pain) 300 mg oral capsule, 1 capsule by mouth three times daily; - Levocetirizine (an antihistamine that is used to treat allergy symptoms) 5 mg, take 0.5 (half) tablet (2.5 mg) every evening; - Singulair (used to treat symptoms of allergies) 10 mg, 1 tablet by mouth every evening; - Sertraline (antidepressant) 25 mg, take 1 tablet by mouth daily; - Januvia (anti-diabetic medication used to help control blood sugar levels) 100 mg, take 1 tablet by mouth daily; and - Review of the clinical record failed to show these medications listed on the patient’s POC (plan of care) and medication profile. Review of the POC, showed: - Antacid (calcium carbonate- helps treat heartburn) 500 mg chewable tablet, 1 tablet oral as needed (no frequency was documented); - Coricidin HBP cough and cold cough suppressant, antihistamine 4mg-30mg (over the counter medication used to treat cold symptoms) 1 tablet, oral use as directed (no detailed instructions documented); - Paliperidone (antipsychotic medication used to treat schizophrenia) 6mg, take 1 tablet every morning; - Ventolin HFA (albuterol- a steroid used to treat or prevent bronchospasms) 108ug (microgram)/1 (per inhalation), inhale 2 (two) puffs every 4 (four) hours as needed; and - Review of the clinical record failed to show, these medications in the referral, physician orders, and/or documentation of these medication discrepancies clarified with the physician. Review of the clinical record, showed the following medications on the referral medication list and the POC: - Buspirone (used to treat anxiety) 10mg tablet, take 1 tablet twice a day; - Trazadone (antidepressant used to treat depression) 100mg tablet, take 2 tablets by mouth at bedtime; and - These medications have the potential for major drug to drug interactions. No record that a drug interaction report was sent to the physician. Review of the drug interactions report, showed: - Using Buspirone and coricidin HBP cough suppressant together, can increase the risk of a rare but serious condition called serotonin syndrome, which may include symptoms such as confusion, hallucination, seizure, extreme changes in blood pressure, increased heart rate, fever, excessive sweating, blurred vision, muscle spasms, nausea, vomiting, or diarrhea. Severe cases may result in coma and even death; - Using Buspirone and trazodone together, can increase the risk of a rare but serious condition called serotonin syndrome; - Using Trazodone and coricidin HBP cough suppressant together, can increase the risk of a rare but serious condition called serotonin syndrome; and - Review of the clinical record failed to show the physician was contacted and sent the drug interaction report. RECORD/PATIENT #6: Review of the referral record, dated, 04/03/2023, showed, a medication list with: - Albuterol 90mcg (microgram)/inhalation (per inhalation), inhale 2 puffs every 4 hours as needed for shortness of air; - Foradil aerolizer (bronchodilator used to treat lung diseases like COPD-chronic obstructive pulmonary disease) 12mcg inhalation capsule, 1 capsule inhalation as needed for shortness of air; - Pantoprazole (reduces stomach acid) 40mg, take 1 tablet daily; - Tums (calcium carbonate), take 1 to 2 chewable tablets by mouth every 4 hours as needed for indigestion; and - Review of the clinical record failed to show these medications listed on the patient’s POC (plan of care) and medication profile. Review of the POC, showed: - Tamsulosin (urinary retention medication) 4mg capsule, take 1 capsule daily; - Pioglitazone (anti-diabetic medication used to help control blood sugar levels) 45mg tablet, take 1 tablet daily; - Metformin (anti-diabetic medication) 1000mg tablet, take 1 tablet twice; - Acetaminophen (analgesic used to treat pain) 500mg, take 1 to 2 tablets as needed; - Aspirin (salicylate- is a non-steroidal anti-inflammatory that is used to treat pain and prevent blood clots from forming by stopping the platelets from clumping together) 81mg, take 1 tablet daily; - Ibuprofen (non-steroid anti-inflammatory) 200mg tablet, take 1 tablet as needed (Frequency was not listed); - Tresiba (anti-diabetic) 100units/1ml, inject 30 units subcutaneous (under the skin) twice daily; - Review of the clinical record failed to show, these medications in the referral, physician orders, and/or documentation of these medication discrepancies clarified with the physician; and - Review of the clinical record showed, Eliquis (blood thinner) 5mg take 1 tablet by mouth daily, on the referral medication list and the POC (Aspirin is not on the referral, major drug to drug interactions are possible when Aspirin and Eliquis are taken together due to increased risk for bleeding, including severe and sometimes fatal hemorrhage. There is no documentation that the physician was contacted to clarify these two medications being taken together). Review of the SOC (start of care) comprehensive assessment, dated, 11/11/2022 showed, the skilled nurse was not able to reconcile all available medications and contacted MD (medical doctor) for missing medications. No documentation of what medications were missing. During an interview, on 05/17/2023, beginning at 10:10 AM, the administrator stated that: - He/she did not realize there were major drug interactions to report to the physician (report was faxed during this interview after administrator realized it was not faxed); - He/she did not contact the physician regarding the medication discrepancies because another physician ordered them; - He/she does not call the primary care provider to report medications the patient is taking when another physician has ordered the medication; - He/she just puts the medications on the POC and sends it to the physician to be signed; and - He/she just tells the patients not to take medications at the same time if there is a possibility of a major drug to drug interaction.

Discharge Planning CFR(s): 484.58 Condition of Participation: Discharge planning. This CONDITION is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to: - Implement an effective discharge planning process (G562); and - Send all necessary medical information pertaining to the patient, to the receiving facility or health care practitioner to ensure the safe and effective transition of care (G564). The cumulative effect of these deficient practices has the potential to affect all patients served by the agency. .

Discharge Planning CFR(s): 484.58(a) Standard: Discharge planning. An HHA must develop and implement an effective discharge planning process. For patients who are transferred to another HHA or who are discharged to a SNF, IRF or LTCH, the HHA must assist patients and their caregivers in selecting a post-acute care provider by using and sharing data that includes, but is not limited to HHA, SNF, IRF, or LTCH data on quality measures and data on resource use measures. The HHA must ensure that the post-acute care data on quality measures and data on resource use measures is relevant and applicable to the patient's goals of care and treatment preferences. This STANDARD is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to implement an effective discharge planning process, in one of two discharge records reviewed (Record/Patient #6). The deficiency has the potential to affect all patients on service with the agency. Findings included: Review of the home health provider's undated policy titled, "Patient/Client Transfer, Discharge and Agency Dissolution," showed, in part; - The home health agency will assess each patient/clients discharge planning and/or continuing care needs on admission and on an ongoing basis and will involve the interdisciplinary care team where appropriate, the physician responsible for the home health plan of care, the patient/client and the representative (if any) or caregiver(s) in the planning process; - The discharge planning information and participation by the patient/client and their representative or caregiver may be documented in the initial comprehensive assessment form, progress notes, or the care coordination documentation; - The home health agency staff will confirm the need for discharge and identify any remaining discharge planning needs; - The home health agency intending to transfer the patient will provide written notification to the patient/client or the patients/client’s parent, family, Spouse, significant other or legal representative; - The home health agency will assist the patient/client and family in choosing an alternative entity by identifying those entities in the area that may be able to meet the patient’s/client’s needs based on the acuity; and - The home health agency will provide the Home Health Change of Care Notice (HHCCN) to inform a patient/client or their representative when the agency is discharging due to agency reasons. RECORD/PATIENT #6: Review of the clinical record, failed to show: - Any discharge planning information provided to the patient and participation by the patient; - Documentation of the HHCCN being provided to the patient; and - Documentation of coordination of care for continuing care needs of the patient and who will provide those needs to the patient at the time of discharge (The patient was bedbound with an indwelling urinary catheter (a soft tube that is inserted into the bladder to drain urine), discharged from home health services, and no documentation of who will provide foley catheter care/maintenance after discharge). During an interview, on 05/17/2023, beginning at 11:45 AM, the office manager stated that: - The patient was not in the hospital at the time of discharge; - Transfer and recertification documentation must have been a mistake; - The patient only had one episode and was discharged after the episode ended; - The patient called the home health agency mad that the agency would not pick the patient back up; and - The patient even filed an appeal with Medicare for the home health agency discharging the patient. During an interview, on 05/18/2023, beginning at 9:45 AM, the patient stated that: - The home health agency (HHA) never provided him/her with written notice of services being terminated; - They (HHA) just dropped him/her; and - His/her PCP (primary care provider) had to assist the patient with finding a new HHA to change his/her catheter. During an interview, on 05/18/2023, beginning at 11:55 AM, the administrator stated that: - The patient was not provided with written notice of transfer with discharge because the patient was in the hospital (No record that the patient was hospitalized); - No transfer and/or discharge summary was sent to the receiving facility because he/she did not know what facility the patient was in; - He/she was informed by “someone” that the patient was in the hospital but he/she did not make any attempts to confirm or verify that the patient was hospitalized; and - No arrangements were made to ensure continuing care needs of the patient were met after discharge from home health services.

Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This STANDARD is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to send all necessary medical information pertaining to the patient, to the receiving facility or health care practitioner to ensure the safe and effective transition of care, in one of two discharge records reviewed (Record/Patient #6). The deficiency has the potential to affect all patients on service with the agency. Findings included: Review of the home health provider's undated policy titled, "Patient/Client Transfer, Discharge and Agency Dissolution," showed, in part; - The home health agency intending to transfer the patient will provide written notification to the patient/client or the patients/client’s parent, family, Spouse, significant other or legal representative; - The home health agency will: * Contact the receiving agency or facility to advise them of the transfer or transfer and discharge, coordinate the transfer date and patient/client care, and establish any specific transfer conditions; * Provide the receiving agency or facility with a transfer summary within two (2) business days of a planned transfer, and within two (2) business days of becoming aware of the transfer when the transfer is unplanned; and - A completed discharge summary will be sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to that patient after discharge from the home health agency within five (5) business days of the patient’s/client’s discharge. RECORD/PATIENT #6: Review of the clinical record, failed to show: - Coordination of care with any facility to advise them of the transfer and discharge; - Documentation of transfer summary being sent to receiving facility; and - Documentation of coordination of care for continuing care needs of the patient and who will provide those needs to the patient at the time of discharge (The patient was bedbound with a foley catheter (a soft tube that is inserted into the bladder to drain urine), discharged from home health services, and no documentation of who will provide foley catheter care/maintenance after discharge). During an interview, on 05/17/2023, beginning at 11:45 AM, the office manager stated that: - The patient was not in the hospital at the time of discharge; - No transfer or discharge summary was sent to a facility; - The transfer and recertification documentation must have been a mistake because the patient only had one episode and was not seen again after that episode ended; and - There should have been discharge documentation at the end of the episode instead of recertification documentation. During an interview, on 05/18/2023, beginning at 11:55 AM, the administrator stated that: - No transfer and/or discharge summary was sent to the receiving facility because he/she did not know what facility the patient was in; and - He/she was informed by “someone” that the patient was in the hospital but he/she did not make any attempts to confirm or verify that the patient was hospitalized.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on record review, home visit observation, and interview, the agency failed to: - Ensure each patient received a written individualized plan of care (POC) with patient specific, measurable outcomes and goals (G572); -Ensure each patient received an individualized plan of care, which included a description of the patient's risk for emergency department visits and hospital re-admissions and goals identified by the patient (G574); - Ensure all patient care orders, including verbal orders, be recorded in the plan of care (G576) - Ensure drugs, services, and treatments administered only as ordered by a physician (G580); - Ensure the individualized plan of care be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the home health agency as frequently as the patient’s condition or needs require, but no less frequently than once every 60 days beginning with the start of care date (G588); - 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 (G590); and - Name and contact information of the clinical manager (622). The cumulative effect of these deficient practices has the potential to affect individualized and physician ordered care provided to all the agency's patients. ..

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on policy review, clinical record review, and interview, the home health provider failed to provide each patient with an individualized plan of care that was established and signed by the physician, in four out of six records reviewed (Records/Patients #1, #2, #3, and #4). The cumulative effect of these deficient practices has the potential to affect the care provided to all agency patients. Findings included: Review of the home health provider’s undated policy titled, “Plan of Care (POC) (484.60 (a)-(e) Must,” showed: - Be reviewed and signed by physician; - If physician refers patient under a plan of care that cannot be completed until after an evaluation visit, the physician is consulted to approve additions or modifications to the original plan; and - Review and revision of the plan of care when the patient’s needs require, no less than once every 60 (sixty) days. Review of the provider’s undated policy titled, “Acceptance of physician orders and verbal orders for home health,” showed: - Physician/verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA’s (home health agency) internal policies. When services are provided on the basis of a physician or allowed practitioner’s verbal orders, a nurse acting in accordance with state licensure requirements or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA’s policies, must document the orders in the patient’s clinical record, and sign and date the orders; - Verbal orders must be authenticated and dated by the physician or allowed practitioner in accordance with applicable state laws and regulations, as well as the HHA’s internal policies. When services are furnished based on a physician’s verbal order, the order must be put into writing by personnel authorized to do so by applicable state law as well as by the HHA’s internal policies; - The orders must be signed and dated, with the date of receipt by the nurse or qualified therapist responsible for furnishing or supervising the ordered services. The HHA should obtain the authentication signature prior to billing; and - The signature may be written or in electronic form following the requirements of the particular system. A method is established to identify the signer. Review of the provider’s undated policy titled, “New Referrals,” showed: - Upon receiving a new referral from any hospital or agency outside of a patient’s PCP (primary care physician), the patient’s PCP must given written/verbal consent for “named home health provider” to treat the patient; and - Orders can be obtained by: * Faxing discharge summary from hospital to patient’s PCP; * Creating a written order and faxing to patient’s PCP; and * Verbal order to PCP. Record/Patient #3: Review of referral discharge special treatments and procedures dated 05/09/2022 showed, in part: - Wound care- right ischium (buttock area) and left fibular head (knee area) -cleanse with wound cleanser and pat dry. Apply silvadene (cream used to prevent and treat wound infections) to the wound bed, cover with xeroform (a non-adherent dressing that maintains a moist wound environment) gauze – and a foam dressing. Change the dressing two times daily and as needed; - Tunneled line removal appointment Thursday, May 5th at 12:30Need to be NPO (nothing by mouth for 8 (eight) hours prior to appointment; - Clean suprapubic (a surgical opening through the wall of the abdomen into the bladder with a sterile tube placed to drain the bladder) two times daily with soap and water, when cleaning with soap and water clean from insertion site down tubing. Keep bag below bladder at all times; - Change foley (sterile tube that drains the bladder) every 30 days, last changed 04/28/2022; - Line care: Keep central line (a sterile catheter placed in a large vein) clean, dry and dressing intact. Change dressing one time weekly and more often if needed. Avoid water over this area, monitor insertion site for redness, tenderness and drainage; - Feeding tube (gastrostomy tube, also called a g tube- a tube inserted through the belly that brings nutrition directly to the stomach) care- Change dressing daily, wash with soap and water daily; - Nutrition- General diet EC7/TNO (easy to chew/healthy), sweetener/no sugar, okay for straws- enteral feeding (feeding through the g tube)- osmolite (therapeutic nutrition delivered via a feeding tube) 1.2 rate 55ml/hr (milliliter per hour) for 10 hours start at 2100 end at 0700. Encourage fluid intake; and - Flush peg tube (g tube) with 30ml water twice daily to maintain patency. Review of the initial POC (plan of care) dated 05/10/2022 to 07/08/2022 showed: - It was not signed by the physician until 09/15/2022; - SN use aseptic technique to clean wound sites (failed to list) with wound cleanser, pat dry, silver sulfadiazine apply to both sites (not listed), xeroform, then cover with foam dressing. SN to change x3 (three times) weekly; - The POC failed to contain any documentation for care of the tunneled line (which is listed on the comprehensive assessment dated 05/10/2022); - The POC failed to contain orders for cleaning the suprapubic site including how, the frequency or by whom; - SN to change suprapubic catheter monthly (failed to include a size or when due next); - G-tube care as needed on each visit (no specific directions) Educate patient’s private aide with care of g-tube care and flush (no specific directions); and - The POC failed to include any enteral feeding orders. Review of the POCs dated 3/06/2023 to 05/04/2023 and 05/05/2023 to 07/08/2023 failed to show: - The attending physician’s signature; and - Failed to show documentation of when they were sent to the physician for signature. Further review of the clinical record failed to show: - Communication documented with the attending physician or physician orders to approve additions or modifications to the referral orders at SOC (start of care); and - Communication with the physician regarding reviewing the POCs once every 60 (sixty) days. During an interview on 05/18/2023 at 12:24 PM the administrator stated that: -He/she does not contact the physician to ensure they are going to follow the patient under home health; - He/she just sends the POC for signature; - Sometimes the doctor just doesn’t sign them and we have to resend several times; and - He/she would expect any discrepancies from the referral treatment orders noted at the SOC visit be clarified with the physician. Finding included: Review of the agency's undated policy titled, "Start of Care Comprehensive Assessment," showed the home health provider’s clinician to prepare the POC because of the clinician's analysis and evaluation of data collected and interventions consulted with and ordered by physician. Patient #4 Review of the discharge orders dated 02/28/2023 showed to contact primary care provider to discuss hospital course, medication changes, home health plan of care, and re-evaluation of patient’s clinical status upon discharge. Review of the POC dated 03/28/2023 through 05/06/2023, failed to show the primary care physician’s signature. There was no documentation to show the provider communicated with the PCP regarding the patient’s hospital course, medications, and home health POC. RECORD/PATIENT #1: Review the referral record showed, in part: - Discipline ordered: SN (skilled nurse) for home safety, medication management, and disease process/management; - PMH (past medical history) of: Bipolar disorder (a disorder with episodes of mood changes that include extreme lows and extreme highs), paranoid type schizophrenia (disorder that affects a person’s ability to think, feel, and behave clearly), body dysmorphic disorder (a mental illness involving obsessive focus on a perceived flaw in appearance), generalized anxiety disorder (severe, ongoing anxiety that interferes with daily activities), insomnia (difficulty sleeping), Type 2 diabetes mellitus (DM II- a chronic condition that affects the way the body processes blood sugar/glucose), acute bacterial rhinosinusitis (an infection in both nasal cavity and sinuses that is caused by bacteria), allergic rhinitis (an allergic response causing itchy, watery eyes, sneezing, and other similar symptoms), and urge urinary incontinence (sudden need to urinate that is difficult to delay and urine may leak before getting to the bathroom); - Patient found to not be taking any of his/her medications daily except for omeprazole (treats heartburn); - The patient had an A1C (blood test that measures the average blood sugar levels over the past three months and the normal range is below 5.6) of 8.9 in February 2023, which was up from 6.7 in November 2022; - Patient counseled on importance of taking medications everyday even if feeling well, as well as adding Invokana (diabetic medication) for better blood sugar control; and - Patient does not see a psychiatrist anymore. Review of the POC showed, in part: - Discipline: SN 2wk6 (two times a week for six weeks); - Orders/treatments included: * SN required to instruct patient on infection control and prevention related to respiratory infections; * SN to document patient competency with glucometer (measures how much sugar is in the blood sample) and daily log; * SN to instruct patient on disease process of DM II to include signs and symptoms of exacerbation and when to call the agency, MD, or 911; * SN to instruct on fall precautions; * SN to instruct on medication safety related to increasing risk of falls and injuries; * SN to instruct on importance of medication compliance; * SN to instruct on all medications throughout the episode; and * SN will report significant changes in patient mental status to MD in a timely manner; - Nutritional requirement: Regular diet (patient is a diabetic with recent history of uncontrolled diabetes); - The POC failed to include patient-specific orders/interventions related to the patient’s medical diagnoses; and - The POC failed to be reviewed and signed by the physician. During an interview on, 05/17/2023, beginning at 10:10 AM, the administrator stated that: - He/she did not contact the physician for POC orders; - He/she develop the POC after the start of care assessment and fax the POC to the physician for signature; and - He/she has not been able to get ahold of the physician to sign the POC and return it.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on policy review, clinical record review, and interviews, the home health provider failed to ensure that each patients' written individualized care plan included all the required elements, in four of six records reviewed (Records/Patients #1, #3, #4, and #6). This deficient practice has the potential to affect all patients served by the provider. Findings included: Review of the provider's undated policy titled, "Plan of Care," showed: - The plan of care (POC) must be individualized; - Contain measurable goals and outcomes; - Be reviewed and signed by physician; - Specify patient/caregiver education/training; - Be within the acceptable standard of practice; - The plan of care must include the following: and * All pertinent diagnosis; * The patient’s mental/psychosocial/cognitive status; * Types of service, supplies and equipment; * Activities permitted; * Rehabilitation potential; * Functional limitations; * Activities permitted; * Nutritional requirements; * All medications and treatments; * Safety measures to protect against injury; * Description of patient’s risk for emergency visits and hospital re-admissions and interventions to address the underlying risk factors; * Patient/caregiver education and training to timely discharge; * Patient specific interventions and education/measurable outcomes/goals identified by the home health provider and patient; * Any other additional items the home health provider/physician may choose; * Orders; and * Risk for emergency room visit and hospitalizations. - Review of the plan of care: * When the patient’s needs require; * No less than every 60 (sixty) days; and * Alert the physician to changes in patient’s condition or outcomes not being achieved/or plan of care is altered. RECORD/PATIENT #3: Review of the referral from a local LTAC (long term acute care) hospital, dated 05/09/2022 showed, in part, the patient was being admitted for SN to provide wound care, suprapubic catheter (a sterile tube inserted through the abdomen into the bladder to drain urine) care, feeding tube (a tube inserted into the stomach to provide nutritional feedings) care, and central line (an intravenous catheter placed in a large vein) care. Review of the discharge summary from the LTAC with a date of discharge of 05/09/2022 showed the patient had a LBKA (left below knee amputation) and paraplegia following spinal cord injury. Review of the OASIS (Outcome and assessment information set- a standardized assessment tool) SOC (start of care) assessment dated 05/09/2022 showed: - Item M 1030 marked yes for Intravenous or infusion therapy and enteral (feeding through feeding tube) nutrition; - Does the patient have IV (intravenous) access? Yes and central line each marked; - Right ischium (buttock area) and left fibula (knee area) pressure wounds documented; - SN to instruct and SN to perform wound care marked; - M1610 Urinary incontinence or catheter present marked 2 – patient requires a urinary catheter (sterile tube placed in the bladder to drain urine; and - Diagnosis of: * Type 2 diabetes * Encounter for adjustment and management of vascular access; and * Encounter for attention to gastrostomy (feeding tube). Review of the initial POC dated 05/10/2022 to 07/08/2022 failed to: - List DME (durable medical equipment)/supplies (left blank) (failed to list hospital bed, dressing supplies, catheter supplies, diabetic supplies, enteral feeding supplies); - Show a diagnosis of a LBKA; and - List the LBKA as a functional limitation. Review of the POC dated 03/06/2023 to 05/04/2023 showed: - Medications left blank; and - DME and supplies left blank. Review of the OASIS recertification assessment dated 05/03/2023 showed: - Diagnosis of: * Type 2 diabetes * Encounter for attention to colostomy; and * Encounter for attention to gastrostomy. - Buttock wound with wound care performed marked yes; - Is the patient using a pressure-relieving device (s) marked yes with air mattress listed; - M1610 Urinary incontinence or catheter present marked 2 – patient requires a urinary catheter; Review of the POC dated 05/05/2023 to 07/03/2023 showed DME and supplies left blank. During an interview on 05/18/2023 at 12:24 PM the administrator stated that he/she would expect all the required components documented in the POC. RECORD/PATIENT #1: Review of the POC, failed to show: - Orders/interventions for blood sugar monitoring (SN performing blood sugar checks on patient during SN visits); - Nutritional requirements pertinent to the patient’s medical history of uncontrolled diabetes (regular diet listed); - Orders/interventions for SN to fill pill planner (SN filling pill planner); - Emergency preparedness code (N/A is listed); and - DME (durable medical equipment) and supplies is left blank (Patient requires supplies for monitoring blood sugars). RECORD/PATIENT #6: Review of the POC, failed to show: - Patient-specific orders/interventions for foley catheter (soft tube inserted into the bladder to drain urine) care/maintenance; - PT (physical therapy) visit frequency and patient-specific orders/interventions (POC only has PT to evaluate and treat); - OT (occupational therapy) visit frequency and patient-specific orders/interventions (POC only has OT to evaluate and treat); - DME and supplies is left blank (Patient requires supplies for monitoring blood sugars, insulin supplies, hoyer lift (assistive device used to transfer a patient), wheelchair, and foley catheter supplies); and - Emergency preparedness code (N/A is listed). Findings included: Review of the agency's undated policy titled, "Plan of Care," showed: - The plan of care must be individualized, contain measurable goals and outcomes, be reviewed and signed by physician, specify patient/caregiver education/training, and be within the acceptable standard of practice; - The plan of care must include the following: * The patient’s mental/psychosocial/cognitive status * Types of service, supplies and equipment * Activities permitted * Rehabilitation potential * Functional limitations * Activities permitted * Nutritional requirements * All medications and treatments * Safety measures to protect against injury * Description of patient’s risk for emergency visits and hospital re-admissions and interventions to address the underlying risk factors * Patient/caregiver education and training to timely discharge * Patient specific interventions and education/measurable outcomes/goals identified by the home health provider and patient * Any other additional items the home health provider/physician may choose * Orders * Risk for emergency room visit and hospitalizations. RECORD/PATIENT #4: Findings included: Review of the discharge orders dated 02/28/2023 showed: - Diagnosis included quadriplegia (paralysis of all four limbs), complicated urinary tract infection (an infection that carries higher risk for treatment failure) encephalopathy (a disease in which the functioning of the brain is affected by some agent or condition), and bilateral heel unstageable wound (full thickness tissue loss); - Problems/medical conditions reviewed in this encounter and that require home health services: Physical therapy, occupational therapy, and nursing; - Bisacodyl suppository (treats constipation) 10 milligram (mg), rectally, three times daily as needed; - Cetirizine (antihistamine) 10 mg daily as needed; - Low fat/cholesterol, 2-gram sodium (heart healthy) diet; - Turn while in bed every two hours; - Turn every one hour when in chair or head of bed is over 30 degrees; - Pressure redistribution boots; - Chair cushion; - Reduce layers of linen; - Position wedges as indicated; - Dressing changes, bilateral heels (showed both heels)- remove old dressings and discard, cleanse with saline and pat dry, apply piece of Aquacel Ag rope (a wound dressing that reduces bacteria and prevents infection) to the left open areas and cover with Mepilex foam border dressing or similar, every Monday, Wednesday, and Friday; - Coccyx and scar tissue areas/high risk- keep clean and cover with Mepilex foam border dressing or similar and change every Monday, Wednesday, and Friday; - Allergies included acetaminophen (treats minor aches and pains and reduces fever), codeine, Floricet (used to treat tension headaches), morphine (can treat moderate to severe pain), oxycodone (can treat moderate to severe pain), and Vicodin (treats pain); and - Contact primary care provider to discuss hospital course, medication changes, home health plan of care, and re-evaluation of patient’s clinical status upon discharge. Review of the POC dated 03/28/2023 through 05/06/2023, failed to show: - Physician orders; - Physical and occupational therapy; - Patient-specific orders/interventions/education for Foley catheter care and urinary tract infection; - Biscacodyl and cetirizine; - Low fat/cholesterol, 2-gram sodium (heart healthy) diet; - Individualized interventions for pressure ulcer prevention/treatment; - Dressing changes to bilateral heels (showed both heels [the POC did not show where to apply the wound treatment]); - Coccyx and scar tissue areas/high risk- keep clean and cover with Mepilex foam border dressing or similar and change every Monday, Wednesday, and Friday; - Allergies (the plan of care showed no known allergies); - Durable medical equipment and supplies; and - Emergency preparedness code (the POC showed non-applicable, the patient was quadriplegic).

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to ensure that all patient care orders were included on the plan of care (POC), in one of six records reviewed (Record/Patient #4). This deficient practice has the potential to affect all patients served by the home health provider. Findings included: Review of the home health provider's undated policy titled, "Plan of Care," showed: - The plan of care must: * Be individualized * Be reviewed and signed by physician - Include the following: * All medications and treatments * Any other additional items the home health provider/physician may choose * Orders. Review of the home health provider’s undated policy titled, "New Referrals," showed: - The purpose is to define assessment parameters for when a new referral is received; - Upon receiving a new referral from any hospital or agency outside of a patient’s primary care physician (PCP), the patient’s PCP must give written/verbal consent for the home health provider to treat the patient; and - Orders can be obtained by faxing discharge summary form hospital to patient’s PCP, creating a written order and faxing to patient’s PCP, and verbal order “to” PCP. RECORD/PATIENT #4: Review of the hospital discharge orders dated 02/28/2023 showed: - Bisacodyl suppository (treats constipation) 10 milligram (mg), rectally, three times daily as needed; - Cetirizine (antihistamine) 10 mg daily as needed; - Low fat/cholesterol, 2-gram sodium (heart healthy) diet; - Turn while in bed every two hours; - Turn every one hour when in chair or head of bed is over 30 degrees; - Pressure redistribution boots; - Chair cushion; - Reduce layers of linen; - Position wedges as indicated; - Dressing changes, bilateral heels (showed both heels)- remove old dressings and discard, cleanse with saline and pat dry, apply piece of Aquacel Ag rope (a wound dressing that reduces bacteria and prevents infection) to the left open areas and cover with Mepilex foam border dressing or similar, every Monday, Wednesday, and Friday; - Coccyx and scar tissue areas/high risk- keep clean and cover with Mepilex foam border dressing or similar and change every Monday, Wednesday, and Friday; and - Contact primary care provider to discuss hospital course, medication changes, home health plan of care, and re-evaluation of patient’s clinical status upon discharge. Review of the POC dated 03/28/2023 through 05/06/2023, failed to show: - Biscacodyl and cetirizine; - Low fat/cholesterol, 2-gram sodium (heart healthy) diet (the POC showed regular high protein encouraged); - Turn while in bed every two hours; - Turn every one hour when in chair or head of bed is over 30 degrees; - Pressure redistribution boots; - Chair cushion; - Reduce layers of linen; - Position wedges as indicated; - Dressing changes to bilateral heels (showed both heels [the POC did not show where to apply the wound treatment]); - Coccyx and scar tissue areas/high risk- keep clean and cover with mepilex foam border dressing or similar and change every Monday, Wednesday, and Friday; and - The physician had not signed the POC, there was no documentation to show the provider communicated with the PCP regarding the patient’s hospital course, medications, and home health POC. During an interview on 05/17/2023 at 9:37 AM, the office manager stated that the POC was faxed to the physician on 02/28/2023 (the patient was admitted to home health on 03/08/2023). There was no physician verbal orders or communication notes with the physician.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on policy review, record review, observation, and interview, the home health provider failed to obtain orders to provide services and treatments only as ordered by a physician or allowed practitioner, in four of six full records reviewed (Records/Patients #1, #2 #3 and #4). This deficient practice has the potential to adversely affect physician driven care of all the provider’s patients. Findings included: Review of the home health provider’s undated policy titled, “Plan of Care (484.60 (a)-(e)),” showed, in part, the plan of care must include the types of services and all medications and treatments. Review of the home health provider’s undated Registered Nurse (RN) Job Description showed the RN furnishes those services requiring substantial and specialized nursing skill that are ordered by the physician as indicated in the plan of care. Review of the POC dated 05/05/2023 to 07/08/2023 failed to show an order for the RN to perform a blood glucose check. Further review of the clinical record failed to show a physician order for the RN to perform a blood glucose check. Observation on 05/ 17/2023 at 9:10 AM, during the patient’s home visit, the nurse was observed performing a blood glucose check. During an interview on 05/18/2023 at 12:24 PM the administrator stated that: - Sometimes we do a blood sugar check; and - We should have an order. RECORD/PATIENT #1: Review of the plan of care (POC), showed, in part: - SN (skilled nurse) to document patient competency with glucometer (measures how much sugar is in the blood sample) and daily log; - SN to instruct patient on disease process of DM II (a chronic condition that affects the way the body processes blood sugar/glucose) to include signs and symptoms of exacerbation and when to call the agency, MD, or 911; - SN to instruct on importance of medication compliance; - SN to instruct on all medications throughout the episode; and - The POC failed to include orders for blood sugar monitoring; - The POC failed to include orders for the SN to check blood sugars; and - The POC failed to include orders for the SN to fill a pill box for the patient. Observation on, 05/17/2023, beginning at, 9:00 AM, during the patient’s home visit, the SN was observed performing a blood sugar check via finger stick. Review of the clinical record failed to show any orders for the SN to perform blood sugar checks and fill a pill planner/box for the patient. During an interview on, 05/17/2023, beginning at 10:10 AM, the administrator stated that: - The POC did not have specific orders for the SN to perform blood sugar checks on the patient and to fill the patient’s pill box because the patient was admitted to home health for medication and disease management; and - These interventions are part of medication and disease management.

Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to ensure the individualized plan of care was reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care, no less frequently than every sixty days, beginning with the start of care, in one of six record reviews, (Record/Patient #3). This deficient practice has the potential to adversely affect the quality and continuity of care for all patients served by the provider. Findings included: Review of the agency's undated policy titled, "Plan of Care," showed review and revision of the plan of care: - When the patient’s needs require; - No less than every 60 (sixty) days; and - To alert the physician to changes in patient’s condition or outcomes not being achieved/or plan of care is altered. RECORD/PATIENT #3: Review of the Initial POC (plan of care), dated 05/10/2022 to 07/08/2022, showed: - The attending physician signature dated 09/15/2022; - May accept orders from alternate MDs (medical doctor); and - The wound care doctor’s name and contact information failed to be listed. Review of the POC dated 03/06/2023 to 05/04/2023 showed: - It failed to be signed by the attending physician; - May accept orders from alternate MDs (medical doctor); and - The wound care doctor’s name and contact information failed to be listed. Review of the POC dated 05/05/2023 to 07/03/2023 showed: - It failed to be signed by the attending physician; - May accept orders from alternate MDs (medical doctor); and - The wound care doctor’s name and contact information failed to be listed. Further review of the clinical record failed to show any communication reviewing the POCs with the attending physician. During an interview on 05/18/2023 at 12:24 PM the administrator stated that: -He/she does not contact the physician to ensure they are going to follow/continue following the patient under home health; - He/she just sends the POC for signature; - He/she didn’t realize the wound doctor’s name had to be listed on the POC; and - Sometimes the doctor just doesn’t sign them and we have to resend several times.

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 policy review, record review, and interview, the home health provider failed to promptly alert the physician to 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, in two of six full records reviewed (Records/Patients #1 and #6). This deficient practice has the potential to affect the coordination of care and services for all patients on service with the agency. Findings included: Review of the home health provider’s undated policy, titled, “Notifying Physician,” showed, in part: - Physician’s should be notified within 24 hours of change in patient conditions; and - Any observation in change of patient condition must be documented and reported to supervising nurse and put in patient file. Review of the provider’s undated policy, titled, “Plan of Care,” showed, in part: - Integrate services to assure the identification of patient needs/factors that could affect patient safety and treatment effectiveness and coordination of care by all disciplines; and - Assure communication with all physicians involved in the plan of care. RECORD/PATIENT #1: Review the clinical record showed, in part: - The SN (skilled nurse) comprehensive assessment note, dated, 04/04/2023, had documentation that the patient had not been checking blood sugars, medications not taken, significant medication issues identified with a comment of, “MD (medical doctor) is aware of the problem and that was one of the reasons for home health admission,” skilled intervention note with, “SN not able to reconcile patient’s medications. Patient will be getting his/her refills and all his/her medications on scheduled visit with MD,” and no documentation that the SN contacted and spoke with the physician regarding the findings; and - Review of the SN visit notes, dated, 04/07/2023, 04/11/2023, 04/14/2023, 04/17/2023, 04/21/2023, 04/24/2023, and 04/27/2023, all had the same documentation that the medications were reviewed, the medication profile was updated, problems were found, and “no” was selected next to MD contacted. During an interview on, 05/17/2023, at 9:55 AM, the administrator stated that: - He/she did not contact the physician regarding blood sugars not being checked because the patient informed him/her that the doctor said that it was okay not to check them; - He/she did not contact the physician to confirm and/or clarify blood sugar monitoring; and - He/she did not contact the physician regarding the medication issues because the patient was admitted to home health for medication and disease management. RECORD/PATIENT #6: Review of the clinical record showed: - Patient admitted to home health services with diagnoses of, spondylosis (degeneration of the spine) with myelopathy (injury to the spinal cord) , acute embolism (obstruction of an artery by a blood clot) and thrombosis of deep veins of lower extremity (blood clot that forms in the deep veins of the legs), and paraplegia (paralysis of the legs); - Review of the POC showed, SN to assess and observe all body systems and report to MD any abnormalities; - Review of the SN comprehensive assessment note, dated, 11/11/2022, showed, the patient had a heart rate of 103 and physician was not contacted regarding heart rate above reporting parameters (POC has pulse to be reported for heart rate above 100); - Review of the SN visit notes, dated, 12/02/2022, 12/09/2022, 12/12/2022, 12/16/2022, and 12/19/2022, all showed the same documentation of, patient’s random blood sugar result of 491, patient had not taken insulin in three (3) days, patient was concerned about his/her health status, and no documentation that the SN contacted and spoke with the physician about significant changes in condition; - PT visit note, dated, 11/28/2022, showed, patient complained of feeling lightheaded, and no documentation of assessment findings being reported to the physician; - OT visit note, dated, 12/04/2022, showed, patient with new pain in left shoulder, encouraged to lay prone to take stress of shoulder, pain rated at 5 out of 10 (0 being no pain and 10 being the worst pain), and no documentation of new symptom onset being reported to the physician; and - PT visit note, dated, 12/15/2022, showed, patient reports not having a good day, therapeutic exercises not performed sitting in wheelchair due to drop in blood pressure, patient symptomatic, patient unable to sustain safe vitals with out of bed mobility, and no documentation of significant changes in condition being reported to the physician. During an interview on, 05/18/2023, at 12:00 PM, the administrator stated that: - He/she did not contact the physician regarding changes in condition; - He/she did not report blood sugars to the physician; and - He/she thought that the random blood sugar reporting parameter was higher than the reporting parameter reading of 400 that was listed on the POC.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on review of the patient’s home health folder during home visit observation and interview, the provider failed to include the name and contact information of the home health provider’s clinical manager in two of three home visits (Records/Patients #2 and #3). This deficient practice has the potential to affect all patients served by the provider. Findings included: RECORD/PATIENT #3: Observation on 05/17/2023 at 09:10 AM, during the patient’s home visit, the home folder was review and failed to contain the written name and contact information of the provider’s clinical manager. During an interview on 05/18/2023 at 12:24 PM the administrator stated that: - He/she was also the clinical manager; and - He/she would have to put that (her name as the clinical manager and contact information) in there (the patients home folder). Findings included: RECORD/PATIENT #2: Observation on 05/17/2023 at 8:20 A.M., during a home visit, the home folder was reviewed and failed to contain the written name and contact information of the provider’s clinical manager.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on review of the agency’s quality assessment performance (QAPI) program and interview, the agency failed to: - Ensure there was evidence that the agency is measuring, analyzing, and tracking quality indicators (G642); - Ensure the agency used data collected to monitor the effectiveness and safety of the services and quality of care and identifying opportunities for improvement (G644); - Ensure the frequency and detail of the data collection was approved by the agency's governing body (G644); - Ensure the agency implemented performance improvement activities (G646); - Ensure the performance improvement activities focused on high risk, high volume, or problems-prone areas (G648); - Ensure the performance improvement activities tracked adverse patient events, analyzed their causes, and implemented preventive actions (G654); Beginning January 13, 2018, HHAs must conduct performance improvement projects: * The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA’s services and operations; * The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects (G658); and - Ensure the governing body was responsible for ensuring an ongoing program for quality improvement and patient safety (G660). The cumulative effect of these deficient practices has the potential to affect the quality of care and safety of all agency patients. .

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on review of home health provider's quality assessment performance (QAPI) program and interview, the agency failed to provide evidence that the agency was measuring, analyzing, and tracking quality indicators. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Review of the QAPI program showed the home health provider failed to have documentation of measurement, analysis, and tracking of quality indicators. The agency failed to use the data to show measurable improvements in indicators and to track quality indicators to assess processes of care, agency services, and operations. Review of governing body meeting minutes for the year of 2022 showed no discussion of a QAPI program for the home health provider. During an interview on 05/17/2023 at 2:15 PM, the administrator stated that a QAPI plan is in place. The problems included not getting the POC back from the physician, staffing, and receiving verbal orders at the start of care. The administrator stated that these issues are not documented and/or tracked. There was no additional information provided.

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on review of home health provider's quality assessment performance (QAPI) program and interview, the agency failed to provide evidence that collection of quality data was on going to: - Monitor the effectiveness and safety of the services and quality of care; and - Identify opportunities for improvement. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Review of the QAPI program showed the home health provider failed to have documentation of on-going monitoring of data. Review of governing body meeting minutes for the year of 2022 showed no discussion of a QAPI program for the home health provider. During an interview on 05/17/2023 at 2:15 PM, the administrator stated that a QAPI plan is in place. The problems included not getting the POC back from the physician, staffing, and receiving verbal orders at the start of care. The administrator stated that these issues are not documented and/or tracked. There was no additional information provided.

Program activities CFR(s): 484.65(c) Standard: Program activities. The HHA's performance improvement activities must-- This STANDARD is not met as evidenced by: Based on review of the home health provider's quality assessment performance (QAPI) program and interview, the agency failed to provide evidence that the performance improvement activities were focused on high risk, high volume, or problems-prone areas This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Review of the QAPI program showed the home health provider failed to have documentation of performance improvement activities that were focused on high risk, high volume, or problems-prone areas. Review of governing body meeting minutes for the year of 2022 showed no discussion of a QAPI program for the home health provider. During an interview on 05/17/2023 at 2:15 PM, the administrator stated that a QAPI plan is in place. The problems included not getting the POC back from the physician, staffing, and receiving verbal orders at the start of care. The administrator stated that these issues are not documented and/or tracked. There was no additional information provided.

High risk, high volume, or problem-prone area CFR(s): 484.65(c)(1)(i) (i) Focus on high risk, high volume, or problem-prone areas; This ELEMENT is not met as evidenced by: Based on review of the home health provider's quality assessment performance (QAPI) program and interview, the agency failed to provide evidence of any performance improvement activities that were focused on high risk, high volume, or problems-prone areas. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Review of the QAPI program showed the home health provider failed to have documentation of performance improvement activities that were: - Focused on high risk, high volume, or problems-prone areas; - Considered the incidence, prevalence, and severity of the problems in those areas; and - Lead to an immediate correction of any identified problem that directly or potentially threatened the health and safety of patients. Review of governing body meeting minutes, dated, 01/10/2022 showed, no discussion of a QAPI program for the home health provider. During an interview on 05/17/2023 at 2:15 PM, the administrator stated that a QAPI plan is in place. The problems are not getting the POC back from the physician, getting staff to work, and getting verbal orders at the start of care. The administrator stated that these issues are not in the plan and they were not in writing and not done. There was no additional information provided.

Track adverse patient events CFR(s): 484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. This STANDARD is not met as evidenced by: Based on review of the home health provider's quality assessment performance (QAPI) program and interview, the agency failed to provide evidence of performance improvement activities to track adverse patient events, analyze their causes, and implement preventative actions. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Review of the QAPI program showed the home health provider failed to have documentation of performance improvement activities that: - Tracked adverse patient events; - Analyze their cause; and - Implement preventative actions. Review of governing body meeting minutes, dated, 01/10/2022 showed, no discussion of a QAPI program for the home health provider. During an interview on 05/17/2023 at 2:15 PM, the administrator stated that a QAPI plan is in place. The problems included not getting the POC back from the physician, staffing, and receiving verbal orders at the start of care. The administrator stated that these issues are not documented and/or tracked. There was no additional information provided.

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on review of the home health provider's quality assessment performance (QAPI) program and interview, the agency failed to provide evidence of any performance improvement activities that were focused on high risk, high volume, or problem prone areas. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Review of the QAPI program showed the home health provider failed to conduct performance improvement projects. Review of governing body meeting minutes for the year of 2022 showed no discussion of a QAPI program for the home health provider. During an interview on 05/17/2023 at 2:15 PM, the administrator stated that a QAPI plan is in place. The problems included not getting the POC back from the physician, staffing, and receiving verbal orders at the start of care. The administrator stated that these issues are not documented and/or tracked. There was no additional information provided.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on review of the home health provider's quality assessment performance (QAPI) program and interview, the agency failed to provide evidence that the governing body was responsible for ensuring the agency had an ongoing program for quality improvement and patient safety. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Review of the quality assessment performance improvement (QAPI) program showed the home health provider failed to show documentation of the governing body involvement in ensuring an ongoing program for quality improvement and patient safety. Review of governing body meeting minutes, dated, 01/10/2022 showed, no discussion of a QAPI program for the home health provider. During an interview on 05/17/2023 at 2:15 PM, the administrator stated that a QAPI plan is in place. The problems included not getting the POC back from the physician, staffing, and receiving verbal orders at the start of care. The administrator stated that these issues are not documented and/or tracked. There was no additional information provided.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to: - Ensure that accepted standards of practice to prevent the transmissions of infections and communicable diseases were followed (G682); and - Maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA’s quality assessment and performance improvement (QAPI) program (G684). The cumulative effect of these deficient practices has the potential to affect all patients served by the home health provider. .

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 policy review, home visit observation, and interview, the home health provider failed to ensure that accepted standards of practice to prevent the transmissions of infections and communicable diseases were followed in one of three home visits conducted (Record/Patient #1). This deficient practice has the potential to affect all patients served by the home health provider. Findings included: Review of the home health provider's undated policy, titled, "Infection Control Policy," showed: - The home health agency (HHA) will use best practices to control and prevent infection and contagious disease; - Areas of focus will include hand washing, bag placement, cleaning the interior and exterior surfaces of the bag, maintenance of equipment and supplies stored in the bag, and management of equipment and supplies removed from the bag; - Infection control manager will be a person trained in infection control to track and manage the program; and - The infection control manager will also provide education to staff. RECORD/PATIENT #1: Observation on 05/17/2023, beginning at 9:00 AM, during the patient's home visit, showed: - Upon entering the home, the nurse (administrator) placed his/her supply bag on a chair with a cloth seat without cleansing the surface and/or having a barrier down; - Equipment for vital signs retrieved from bag one at a time, as the nurse needed them; - He/she sprayed the blood pressure cuff (no other area of the blood pressure machine was sprayed) with a can of spray labeled “Lysol” after use and immediately placed back into bag prior to obtaining next equipment needed for vital signs; - He/she sprayed the bell part of the stethoscope (no other area of the stethoscope was sprayed) after use and immediately placed back; - He/she did not sanitize hands prior to reaching into bag for equipment and/or supplies; and - He/she retrieved gloves from bag, applied gloves, obtained the patient’s blood sugar via finger stick, removed gloves, and failed to sanitize hands before or after checking the patient’s blood sugar. During an interview on 05/18/2023 at11:40 AM, the administrator stated that: - A barrier should be used if placing bag on the floor but not if bag is placed on a surface; - Hand sanitizer should be used to clean hands before entering bag; - Lysol spray is what he/she uses to disinfect equipment; and - He/she is unsure of the manufactures recommendations for proper disinfection for the equipment.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on review of policy, infection control meeting minutes and interview, the home health provider failed to maintain a coordinated agency-wide program for prevention, control and investigation of infectious and communicable diseases that was part of the agency's quality assessment and performance improvement (QAPI) program. This deficient practice has the potential to affect the health and safety of all the home health provider's patients. Findings included: Review of the home health provider's policy titled, "Quality Assessment and Performance Improvement Plan (QAPI)," revised 01/13/2018, showed that patient/client and employee infections will be measured, analyzed, and tracked to allow the agency to assess processes of care, agency services, and operations. Review of the QAPI plan for calendar year 2022, showed monitoring, trending and identifying significant outcomes that are essential to optimal care: Patient and employee infections. Review of the governing body minutes for the year of 2022 failed to show information regarding QAPI and infection control. During an interview on 05/17/2023 at 2:15 PM, the administrator stated that a QAPI plan is in place. The board discusses infection control, who had infections, the treatment, this documentation was on a separate piece of paper, and he/she will try to find the documentation. There was no additional information provided.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to: - Ensure ongoing interdisciplinary assessment of the patient (G706); and - Communicate with all physicians involved in the plan of care (G718). The cumulative effect of these deficient practices has the potential to affect all patients served by the agency.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to ensure ongoing interdisciplinary assessment of the patient, in one of six full records reviewed (Record/Patient #6). This deficient practice has the potential to affect the coordination of care and services for all patients on service with the agency. Findings included: Review of the provider’s undated policy, titled, “Plan of Care,” showed, in part: - Integrate services to assure the identification of patient needs/factors that could affect patient safety and treatment effectiveness and coordination of care by all disciplines; and - Assure communication with all physicians involved in the plan of care. RECORD/PATIENT #6: Review of the clinical record showed: - Patient admitted to home health services with diagnoses of, spondylosis (degeneration of the spine) with myelopathy (injury to the spinal cord) , acute embolism (obstruction of an artery by a blood clot) and thrombosis of deep veins of lower extremity (blood clot that forms in the deep veins of the legs), and paraplegia (paralysis of the legs); - SN (skilled nurse) comprehensive assessment, dated, 11/11/2022, showed, patient is bedridden, lives alone, requires total assistance, and has a foley catheter (a soft tube inserted into the bladder that drains urine); - PT (physical therapy) visit note, dated, 11/26/2022, showed, patient with increased weakness this date compared to previous sessions, foley catheter leaking throughout session, sheets saturated with urine, and no documentation of assessment findings being reported to the SN for assessment; - OT (occupational therapy) visit note, dated, 11/26/2022, showed, foley catheter bag leaking, and no documentation of assessment findings being reported to the SN for assessment; - PT visit note, dated, 11/28/2022, showed, patient complained of feeling lightheaded, and no documentation of assessment findings being reported to the SN for assessment; - OT visit note, dated, 12/04/2022, showed, patient with new pain in left shoulder, encouraged to lay prone to take stress of shoulder, pain rated at 5 out of 10 (0 being no pain and 10 being the worst pain), and no documentation of findings being reported to SN for assessment; - PT missed visit note, dated, 12/06/2022, showed, patient refused visit due to “not having a good day,” agency notification had “no” selected, and physician’s office notified had “no” selected; - OT missed visit note, dated, 12/06/2022, showed, patient declined therapy, not feeling well, agency notification had “no” selected, and physician’s office notified had “no” selected; - PT missed visit note, dated, 12/14/2022, showed, patient refused visit due to “not having a good day,” agency notification had “no” selected, and physician’s office notified had “no” selected; and - PT visit note, dated, 12/15/2022, showed, patient reports not having a good day, therapeutic exercises not performed sitting in wheelchair due to drop in blood pressure, patient symptomatic, patient unable to sustain safe vitals with out of bed mobility, and no documentation of change in condition being reported to SN for assessment. During an interview on, 05/18/2023, at 12:00 PM, the administrator stated that: - He/she was never notified of the catheter leaking and saturating the bed sheets; - He/she had no idea the patient was having lightheadedness and drop in blood pressure; and - He/she did not assess the patient’s changes in condition due to not being made aware of them.

Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This ELEMENT is not met as evidenced by: Based on policy review, clinical record review, and interview, the home health provider failed to communicate with all physicians involved in the plan of care (POC) in one of six full records reviewed (Record/Patient #3). This deficient practice has the potential to adversely affect all patients receiving care from multiple physicians. Findings included: Review of the home health provider’s undated policy titled, “Policy 4.18: Coordination of Services,” showed: - All skilled clinicians and unskilled personnel furnishing care maintain liaison to ensure that client services are coordinated effectively and in accordance with the objectives outlined in the plan of care; and - If the referral comes from another physician other than the primary care physician, the DON (director of nursing)/coordinator will contact the primary care physician (attending physician) on admission to notify him or her of their patient’s admission and ask if they have any orders they would like to add at that time. Then include the primary care physician contact information on the plan of care. Review of the agency's undated policy titled, "Plan of Care," showed coordination of care: - Assure communication with all physicians involved in the plan of care; - Integrate orders from all physicians involved in the plan of care to assure full coordination of all services and interventions provided to the patient; - Coordinate care delivery to meet patient’s needs and involve patient/representative/caregiver. RECORD/PATIENT #3: Review of the clinical record showed: - A face to face encounter form, dated 04/27/2022, that showed the attending physician’s name listed as the physician following the patient after discharge; - A fax cover form addressed to the wound doctor dated 05/17/2023 with a comment written in that stated please fax to us after sign. State survey is at our office; - A POC dated 03/06/2023 to 05/04/2023 with a line drawn through the attending physician name and address and handwritten in the wound care doctor’s name and phone number; - A signature by the wound doctor dated 05/17/2023; - The record failed to contain documentation that the attending physician was to change to the wound doctor; and - The record failed to contain any documentation of a patient or caregiver request to change the attending physician. During an interview on 05/18/2023 at 12:24 PM the administrator stated that: - The patient’s attending physician nor the wound doctor had changed; and - He/she just knew the provider needed a signature on the POC so one was sent to the attending physician with their name listed and he/she (administrator) drew a line through the attending and documented the wound doctor’s name and sent that POC to the wound doctor for signature; and - He/she denied any communication with either physician or the patient/caregiver about changing the attending physician to the wound doctor.

Org. had partial/extended survey CFR(s): 484.80(f)(3) Was subjected to an extended (or partially extended) survey as a result of having been found to have furnished substandard care (or for other reasons as determined by CMS or the state); or This ELEMENT is not met as evidenced by: Based on the results of this extended level survey, resulting in noncompliance with ten Conditions of Participation: Patient rights; Comprehensive Assessment of Patients; Discharge Planning; Care Planning, Coordination of Services, and Quality of Care; Quality Assessment and Performance Improvement; Infection Control; Skilled Professional Services; Clinical Records; Organization and Administration of Services, and Emergency Preparedness, the agency may not train or competency evaluate their home health aides for a period of two (2) years following the date of this survey. The restriction ends 05/18/2025. .

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on observation and interviews, the home health provider failed to organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care when the agency failed to showed a functioning governing body, administrative, and clinical manager oversight to patients resulting in ten conditions of participation citations. The following standard level deficiencies were cited under this condition of participation: - The governing body assumed full legal authority and responsibility for the agency management, operation, and the provision of all home health services including its quality assessment performance improvement (QAPI) program (G942); and - The administrator was responsible for all day-to-day operations of the agency (G948). The cumulative effect of these systemic practices resulted in the agency's inability to ensure the patient's care needs would be met.

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on requested document review, and interview, the home health provider failed to demonstrate and ensure the governing body had assumed effective oversight responsibility for the operation of the agency. The deficient practice has the potential to affect all patients served by the home health health provider. Findings included: The agency failed to show evidence/documentation of the governing body involvement in ensuring an ongoing program for quality improvement and patient safety. During an interview on 05/17/2023 at 2:15 PM, the administrator stated that a QAPI plan is in place. The board discusses infection control, who had infections, the treatment, this documentation was on a separate piece of paper, and he/she will try to find the documentation. There was no additional information provided.

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on current survey findings, home health administrator job description review, and interview, it cannot be assured the administrator has effectively assumed responsibilities for the overall administration, supervisory functions, and overall operations of the home health agency. The agency failed to show the administrator was responsible for all day to day operations of the home health provider. This deficient practice has the potential to affect all the patients receiving services from the home health provider. Findings included: Condition-level deficiencies are identified at: §484.50 Condition of Participation: Patient Rights; §484.55 Condition of Participation: Comprehensive Assessment of Patients; §484.58 Condition of Participation: Discharge planning; §484.60 Condition of Participation: Care Planning, Coordination and Quality of Care; §484.65 Condition of Participation: Quality Assessment and Performance Improvement; §484.70 Condition of Participation: Infection Control; §484.75 Condition of Participation: Skilled Professional Services; §484.105 Condition of Participation: Organization and Administration of Services; §484.110 Condition of Participation: Clinical Records; and §484.102 Condition of Participation: Emergency Preparedness for Home Health Agencies. Review of the home health provider’s undated policy, titled, “Policy for Administrator for Home Health,” showed, the administrator will be: - Responsible for all the day to day operations of the home health provider; and - Responsible to ensure that the home health employs qualified personnel, including assuring the development of personnel qualifications and policies. Review of the undated job description of the Administrator, showed: - The primary function is to organize and direct the agency’s ongoing function; - Promotes efficient functioning and coordination of all agency activities to ensure the highest level of professional patient care; - Requires ability to handle stressful situations and requires working under some stressful conditions to meet deadlines and patient needs, and to make quick decisions and resource acquisition; - Demonstrates an in-depth knowledge of, and ensures compliance with, all local, state and federal laws, relating of the operation of the agency and stays current on local issues and trends; - Plans and directs programs through delegation of responsibility to administrative and supervisory personnel for operations; - Organizes and directs the organizations’ ongoing operations to assure the availability and provision of adequate and appropriate care and services and establishes and maintains effective channels of communication; - Implements governing body directives and organizational policies and procedures and ensures that appropriate service policies are developed and implemented; - Ensures program personnel have current clinical information and current practices; - Assures the development and qualifications for professional services and the assignment of personnel and assures that skilled nursing and other therapeutic services furnished are under the supervision and direction of a physician or a registered nurse; - Directs and monitors performance improvement activities; and - Evaluates program, services and personnel and directs preparation of annual report of operations and annual agency evaluation. During an entrance interview, on 05/16/2023, beginning at 9:20 AM, the office manager stated that, the administrator was out doing nursing visits, and the administrator was also the clinical manager. The office manager was listed as the administrator with the bureau of homecare and rehabilitation standards, he/she stated that he/she did not think he/she was the administrator, but may as well be because he/she runs the office. The agency has trouble with staffing, the administrator is the only nurse, and they were not accepting any new referrals. When asked for the patient visits for the week, he/she stated he/she would have to contact staff to find out their schedule because they arrange the visits with the patients. The home health provider's owner/administrator also owns/operates the in-home health and workman's compensation cases portion of the home health provider.

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to: - Ensure a completed discharge summary was sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge process (G1022); and - Ensure all documented entries included appropriate authentication that included, the time the plans of care were completed, the plan of care signed by the nurse, plans of care signed and dated by the physician, and documentation of the visits were completed timely (G1024). The cumulative effect of these deficient practices has the potential to affect all patients served by the agency.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to ensure a completed discharge summary was sent to the health care professional responsible for providing care and services to the patient after discharge, in one of two discharge records reviewed (Record/Patient #6). This deficient practice has the potential to affect all discharged or transferred patients served by the agency. Findings included: Review of the home health provider's undated policy, titled, "Patient/Client Transfer, Discharge and Agency Dissolution," showed, in part; - The home health agency will: * Contact the receiving agency or facility to advise them of the transfer or transfer and discharge, coordinate the transfer date and patient/client care, and establish any specific transfer conditions; * Provide the receiving agency or facility with a transfer summary within two (2) business days of a planned transfer, and within two (2) business days of becoming aware of the transfer when the transfer is unplanned; and - A completed discharge summary will be sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to that patient after discharge from the home health agency within five (5) business days of the patient’s/client’s discharge. RECORD/PATIENT #6: Review of the clinical record, showed: - A transfer visit note, dated, 02/09/2023, showed, in part: * Transferred to an inpatient facility with discharge from the home health agency; * Inpatient facility had hospital selected; and * Transfer record failed to include documentation of communication with any hospital (no record that the patient was hospitalized); - A discharge summary note, dated, 02/09/2023, showed: * Yes as per current plan of care, was selected for continuing care needs (Patient is bedbound, requires assistance with a lift to transfer out of bed, and has a foley catheter); * Yes, was selected for the patient having resources available to meet on-going needs (No documentation of what resources were available); * Discharge/transfer instructions included, counseled to call agency for future home care needs (No documentation of who was counseled to call the agency for future home care needs); * Patient status at discharge/transfer: unstable health condition, patient has been admitted to the hospital, and agency will not be taking patient back (No documentation of arrangements made for a safe discharge); * Summary of care provided included, monthly foley catheter (soft tube inserted into the bladder to drain urine) change without complications. Patient transferred and discharged to hospital. Agency will no longer accept patient back until patient gets the rehab needed to get patient to functional level status (No documentation of coordination of care with the physician and/or other healthcare provider to transfer and/or discharge the patient due to the agency being unable to meet the patient's needs); * Yes was selected for patient discharged unexpectedly; and * Copy of summary sent to MD (medical doctor) with current PCP, was selected with an X in the box (No documentation provided that any transfer and/or discharge summary was sent to the primary care provider and/or other healthcare professional responsible for providing care and services to the patient after discharge). During an interview, on 05/18/2023, beginning at 11:55 AM, the administrator stated that: - No transfer and/or discharge summary was sent to the receiving facility because he/she did not know what facility the patient was in; and - He/she was informed by “someone” (unable to recall who informed him/her) that the patient was in the hospital but he/she did not make any attempts to confirm or verify that the patient was hospitalized.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to ensure all documented entries included appropriate authentication that included, the time the plans of care were completed, the plan of care signed by the nurse, plans of care signed and dated by the physician, and documentation of the visits were completed timely, in five of six full records reviewed (Records/Patients #1, #2, #3, #4 and #6). This deficient practice has the potential to affect all discharged or transferred patients served by the agency. Findings included: Review of the home health provider's undated policy, titled, "Acceptance of Physician Orders and Verbal Orders for Home Health," showed, in part; - When services are provided on the basis of a physician or allowed practitioner’s verbal orders, a nurse acting in accordance with state licensure requirements or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA’s (home health agency) policies, must document the orders in the patient’s clinical record, and sign, date, and time the orders; - Orders must be signed and dated, with the date of receipt by the nurse or qualified therapist responsible for furnishing or supervising the ordered services; and - The HHA should obtain physician authentication signature prior to billing. Review of the home health provider's undated policy, titled, "Clinical Record Policy,” showed, documentation is expected at the time of the visit but if cannot be done at that time then documentation must be done in 72 (seventy-two) hours of the home visit. RECORD/PATIENT #1: Review of the plan of care (POC), dated, 04/04/2023 to 06/02/2023, showed: - Name/signature of nurse/therapist and date was blank; and - Signature and date of physician was blank. Review of the clinical record failed to show any written and/or verbal orders entered into the electronic medical record and/or signed by a physician. RECORD/PATIENT #6: Review of the clinical record, showed: - An OT (occupational therapy) visit note, dated, 12/03/2022, with a start time of 11:00 AM and an end time if 11:45 AM, had no other documentation completed for the visit and the signature line was left blank; - A recertification visit note, dated, 01/06/2023; and - The clinical record failed to show any written and/or verbal orders entered into the electronic medical record and/or signed by a physician. During an interview on 05/17/2023, beginning at 10:10 AM, the administrator stated that: - He/she doesn’t call the physician for POC orders; - He/she develops the POC based on his/her assessment of the patient at the time of SOC and just faxes the POC to the physician to be signed; - He/she has been trying to get physician signatures for all of the plan of cares; - He/she is behind on documentation and was caught off guard because he/she thought that the agency was not supposed to have a survey until September; and - He/she has reached out to all of the physicians again and informed them that he/she needs the POC’s signed because state is here. RECORD/PATIENT #4: Review of the plan of care (POC), dated, 03/08/2023 to 05/06/2023, showed: the signature and date of physician was blank. Review of the clinical record failed to show any written and/or verbal orders entered into the electronic medical record and/or signed by a physician. RECORD/PATIENT #3: Review of the POC dated 03/06/2023 to 05/04/2023 showed: - It failed to be signed by the attending physician; and - Lines drawn through the attending physician’s name and contact info with the wound doctor’s name written and telephone number, signed and dated by the wound doctor with a date of 05/17/2023. Further review of the clinical record failed to show any written and/or verbal orders entered into the electronic medical record and/or signed by a physician. During an interview on 05/18/2023 at 12:24 PM the administrator stated that: -He/she does not contact the physician to ensure they are going to follow/continue following the patient under home health; - He/she just sends the POC for signature; and - Sometimes the doctor just doesn’t sign them and we have to resend several times. RECORD/PATIENT #2 Review of the patient’s diagnosis included: non -pressure wound to the left foot, diabetes type II (a medical condition in which the body regulates and uses sugar as a fuel), and morbid obesity. Review of the physician referral dated 03/14/2023 showed an order for Skilled Nursing (SN) for wound care. Review of the comprehensive assessment dated 03/16/2023 under the section for orders for discipline and treatments showed: - SN to provide education on to the patient regarding prescribed medications; - SN to provide wound care to and provide the patient education regarding wound care, and infection control regarding wounds to the fingers of the left hand , left leg and left heel; - SN to provide fall prevention interventions and education to prevent falls and re- hospitalization. Review of the POC dated 03/16/2023 to 5/14/2023 failed to show a physician’s signature regarding the patient’s care, medication administration, and wound treatments.