Caring Hearts Health Care Services, LLC.

“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 a review of agency’s policies, Clinical Records (CR), and an interview with the administrator, Chief Executive Officer (CEO) and director of nursing (DON), the home health agency (HHA) failed to ensure that the individualized plan of care include the frequency and duration of visits, all medications and treatments (G574); to administer drugs, services, and treatments only as ordered by a physician or allowed practitioner (G580); to ensure that (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA’s internal policies; (4) 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, date, and time 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 (G584); to ensure 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 (G588). Findings include: This condition is not met as evidenced under the following standards which did not result in immediate jeopardy. This condition was not met based on non-compliance with the above standards: §484.60(a)(2)(i-xvi) Plan Of Care Must Include The Following §484.60(b)(1) Only As Ordered By A Physician §484.60(b)(3)(4) Verbal Orders §484.60(c)(1) Reviewed, Revised By Physicians Every 60 Days”

“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 review of agency’s policies, Emergency Preparedness plan and interview with agency administrator, Chief Executive Officer (CEO) and director of nursing (DON), it was determined the agency failed to conduct exercises to test the emergency plan annually. Findings include: A review of agency’s policies was conducted on 7/11/25 approximately 3 pm. A policy titled, “6.1 EMERGENCY PREPAREDNESS PLAN” reads, “… POLICY: … 8. The agency must maintain documentation of compliance with emergency preparedness… d. Conduct an additional exercise every two years opposite the year the full-scale or functional exercise is conducted, that may include, but is not limited to, the following: i. a second full scale exercise that is community-based or individual, agency-base or; ii. A table top exercise that include a group discussion led the administrator, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge the emergency plan. iii. A mock disaster; or…” A review of agency Emergency Preparedness plan on 7/11/25 at approximately 2:00 pm revealed no documentation of any exercises to test the emergency plan in 2024. An interview conducted with the administrator, CEO and DON on 7/11/25 starting at 4 pm confirmed the above findings.”

“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 a review of agency policy, clinical record (CR), and an interview with administrator, it was determined that the agency failed to update of the comprehensive assessment which include a summary of the patient’s progress in meeting the care plan goals at discharge for one (1) of seven (7) clinical record reviewed: CR#6. Findings include: A review of agency’s policies was conducted on 7/11/25 starting at 3 pm. A policy titled, “PAHH1.19 – OUTCOME AND ASSESSMENT INFORMATION SET (OASIS) reads, “POLICY: The outcome and Assessment information set (OASIS) will be completed by a registered nurse at specific points in time all Medicare, Medicaid, private insurance and self-pay adult skilled home care clients. It will be then transmitted to CMS. PROCEDURE: … The time points are: 1. Start of care, 2. Resumption of care following an inpatient facility stay, 3. Recertification (within the last five days of each 60 day certification period), 4. Other follow-up: For example “Significant Change in Condition,” … 7. Death at home, 8. Discharge from Agency. All assessments, except transfer to inpatient facility and death at home, require an in-person encounter with the client during a home visit. Start of Care Assessment: All new clients admitted to home health services, regardless of payor, are to have the Start of Care assessment and the OASIS data set completed. The Agency Start of Care assessment questionnaire contains all required Medicare questions as well as other added questions to follow for a comprehensive client assessment… 2. Current clients that do not have the OASIS data set will be required to have the SOC assessment/OASIS data set completed using the following procedure: a. Current clients who are admitted to the hospital will have an interruption of service form completed. While the client is in an inpatient status, a discharge form is to be completed along with a discharge order. … Follow-up/Recertification (Within the last 5 days of each certification period): 1. All clients, regardless of payor type, will have the follow-up assessment of the OASIS data set questionnaire completed to allow for a comprehensive assessment. The Follow-up assessment will be part of the certification process. Discharge (not to an inpatient facility): 1. All client, regardless of the payor type, will have the discharge assessment of the OASIS data set questionnaire completed to allow for a comprehensive assessment…” A review of CR’s was conducted on 7/9/2025 starting at approximately 3 pm, on 7/10/25 starting at 9:00 AM and again on 7/11/25 starting at 8:30 am. The Start of Care (SOC) and CMS-485 Home Health and Certification Period (CP) are shown below. CR#6 SOC 5/14/21, discharge date unknown, contains a discharge assessment completed on 1/25/24, CP is left blank, and the following assessment criteria were left blank: date of discharge, integumentary assessment, respiratory assessment, elimination assessment, mental status assessment. An interview with agency’s administrator, CEO and director of nursing on 7/11/5 starting at 4 pm confirmed the above findings.”

“Written instructions to patient include: CFR(s): 484.60(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining: This Standard is not met as evidenced by: Based on a review of agency’s policies, home visit observations and interviews with the administrator, Chief Executive Officer (CEO) and director of nursing (DON), patients and patient’s family members, the home health agency failed to provide the patient and caregiver with a copy of written instructions for one (1) of three (3) home visit observations: observation # 1. Findings include: A review of agency’s policies was conducted on 7/11/25 starting at 3 pm. A policy titled, “HH3.1 – PATIENT SERVICE PROVISION” reads, “ADMISSION DOCUMENTS: upon admission to agency, each patient/family will receive: 1. Admission Booklet which contains (at a minimum) the following educational information: a. agency contact information for questions, concerns, or complaints. b. a copy of the patient bill of rights and responsibilities, and the state home health complaint, child abuse, county specific, and accreditation agency hotline numbers. … c. a copy of agency’s patient grievance policy. d. a description of available services, service charges, payment sources, discharge planning process, and geographic area served. E. information on advanced directives. F. a copy of the agency’s policy on abuse, neglect, and exploitation….3. copy of the Plan of Care and medication list…” Patient home visit observations and Interviews with patient and patient’s family were conducted on 7/8/25 staring at 10 am and 7/9/25 starting at 10:30 am and again at 12 pm. Observation#1: on 7/8/25, CR#1’s son was asked if patient or the family has received any written documents or instruction regarding patient rights from the home health agency. The son stated, “I think I did but I think I lost it,” while looking through envelopes. There was a folder in the patient’s kitchen that included handwritten medication lists one with no date and 2 with date of 7/1/23 and 8/7/23, a printed copy of medication profile dated 6/27/24, The folder did not contain patient’s rights or current plan of care. An interview conducted with the administrator, CEO and DON on 7/11/25 starting at 4 pm confirmed the above findings.”

“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 a review of agency’s policies, home visit observations and interviews with the administrator, Chief Executive Officer (CEO) and director of nursing (DON), patients and patient’s family members, the home health agency failed to provide the patient and caregiver with a copy of written instructions for one (1) of three (3) home visit observations: observation # 2. Findings include: A review of agency’s policies was conducted on 7/11/25 starting at 3 pm. A policy titled, “HH3.1 – PATIENT SERVICE PROVISION” reads, “ADMISSION DOCUMETNS: upon admission to agency, each patient/family will receive: 1. Admission Booklet which contains (at a minimum) the following educational information: a. agency contact information for questions, concerns, or complaints. b. a copy of the patient bill of rights and responsibilities, and the state home health complaint, child abuse, county specific, and accreditation agency hotline numbers. … c. a copy of agency’s patient grievance policy. d. a description of available services, service charges, payment sources, discharge planning process, and geographic area served. E. information on advanced directives. F. a copy of the agency’s policy on abuse, neglect, and exploitation….3. copy of the Plan of Care and medication list. 4. Patient home visit observations and Interviews with patient and patient’s family were conducted on 7/8/25 staring at 10 am and 7/9/25 starting at 10:30 am and again at 12 pm. Observation #2: on 7/9/25, CR#2 was asked if CR#2 has received any written documents or instruction regarding patient rights from the home health agency. The agency’s onsite staff nurse brought a folder to patient and stated patient received it. The patient stated, “I have never seen this before.” Surveyor asked if CR#2 knows Department of Health hotline number and CR#2 stated, she does not know. A review of the folder revealed, agency did not provide addresses, and telephone numbers of the following Federally funded and state-funded entities that serve the area where the patient resides:: i) Agency on Aging, (ii) Center for Independent Living, (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. An interview conducted with the administrator, CEO and DON on 7/11/25 starting at 4 pm confirmed the above findings.”

“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 a review of clinical records (CR), agency’s policies, and an interview with the administrator, Chief Executive Officer (CEO) and director of nursing (DON), the agency failed to provide a comprehensive assessment that is updated and revised as frequently as the patient’s condition warrants due to a major decline or improvement in the patient’s health status for two (2) of seven (7) clinical records reviewed: CR# 1 and 3. Findings include: A review of agency’s policies was conducted on 7/11/25 starting at 3 pm. A policy titled, “PAHH1.19 – OUTCOME AND ASSESSMENT INFORMATION SET (OASIS) reads, “POLICY: The outcome and Assessment information set (OASIS) will be completed by a registered nurse at specific points in time all Medicare, Medicaid, private insurance and self-pay adult skilled home care clients. It will be then transmitted to CMS. PROCEDURE: … The time points are: 1. Start of care, 2. Resumption of care following an inpatient facility stay, 3. Recertification (within the last five days of each 60 day certification period), 4. Other follow-up: For example “Significant Change in Condition,” … 7. Death at home, 8. Discharge from Agency. All assessments, except transfer to inpatient facility and death at home, require an in-person encounter with the client during a home visit. Start of Care Assessment: All new clients admitted to home health services, regardless of payor, are to have the Start of Care assessment and the OASIS data set completed. The Agency Start of Care assessment questionnaire contains all required Medicare questions as well as other added questions to follow for a comprehensive client assessment… 2. Current clients that do not have the OASIS data set will be required to have the SOC assessment/OASIS data set completed using the following procedure: a. Current clients who are admitted to the hospital will have an interruption of service form completed. While the client is in an inpatient status, a discharge form is to be completed along with a discharge order. … Follow-up/Recertification (Within the last 5 days of each certification period): 1. All clients, regardless of payor type, will have the follow-up assessment of the OASIS data set questionnaire completed to allow for a comprehensive assessment. The Follow-up assessment will be part of the certification process. Discharge (not to an inpatient facility): 1. All client, regardless of the payor type, will have the discharge assessment of the OASIS data set questionnaire completed to allow for a comprehensive assessment…” A review of CR’s on 7/9/2025 starting at approximately 3 pm, on 7/10/25 starting at 9:00 AM and again on 7/11/25 starting at 8:30 am. The Start of Care (SOC) and CMS-485 Home Health and Certification Period (CP) are shown below. CR#1 SOC 7/1/23 File contains 3 comprehensive assessments completed on: 9/18/24 (for CP 8/24/24-10/22/24), 4/29/25 (for CP 4/21/25-6/19/25) and 6/17/25 (for CP 6/20/25-8-18-25). The file did not contain a recertification comprehensive assessment/care plan from 10/22/24 until 4/29/25. There was no documentation of any interruption of service. CR#3 SOC 1/15/25, indicated that the first comprehensive assessment was completed on 1/23/25, for CP from 1/15/25 to 3/15/25, which was not completed within the first 5 days of start of care and the following assessment criteria were left blank: immunization, cardiovascular system including blood pressure and heart sounds, ear/nose/throat/mouth, respiratory status, endocrine, neuro/emotional/mental status. The file did not contain a recertification comprehensive assessment from 3/15/25 until 6/3/25 (CP 6/3/25-8/3/25). There was no documentation of any interruption of service. An interview conducted with the CEO, administrator, director of nursing on July 11, 2025 starting at 4 pm confirmed the above findings.”

“5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient’s immediate needs, but no later than 5 calendar days after the start of care. This Element is not met as evidenced by: Based on a review of agency policy, a review of patient clinical records (CR), and an interview with the agency’s administrator, Chief Executive Officer (CEO) and director of nursing (DON), the agency failed to ensure a comprehensive assessment was conducted no later than (5) calendar days after the start of care for one (1) of seven (7) CR reviewed: CR#3. Findings include: A review of agency’s policies was conducted on 7/11/25 starting at 3 pm. A policy titled, “PAHH1.19 – OUTCOME AND ASSESSMENT INFORMATION SET (OASIS) reads, “POLICY: The outcome and Assessment information set (OASIS) will be completed by a registered nurse at specific points in time all Medicare, Medicaid, private insurance and self-pay adult skilled home care clients. It will be then transmitted to CMS. PROCEDURE: … The time points are: 1. Start of care, 2. Resumption of care following an inpatient facility stay, 3. Recertification (within the last five days of each 60 day certification period), 4. Other follow-up: For example “Significant Change in Condition,” … 7. Death at home, 8. Discharge from Agency. All assessments, except transfer to inpatient facility and death at home, require an in-person encounter with the client during a home visit. Start of Care Assessment: All new clients admitted to home health services, regardless of payor, are to have the Start of Care assessment and the OASIS data set completed. The Agency Start of Care assessment questionnaire contains all required Medicare questions as well as other added questions to follow for a comprehensive client assessment… 2. Current clients that do not have the OASIS data set will be required to have the SOC assessment/OASIS data set completed using the following procedure: a. Current clients who are admitted to the hospital will have an interruption of service form completed. While the client is in an inpatient status, a discharge form is to be completed along with a discharge order. … Follow-up/Recertification (Within the last 5 days of each certification period): 1. All clients, regardless of payor type, will have the follow-up assessment of the OASIS data set questionnaire completed to allow for a comprehensive assessment. The Follow-up assessment will be part of the certification process. Discharge (not to an inpatient facility): 1. All client, regardless of the payor type, will have the discharge assessment of the OASIS data set questionnaire completed to allow for a comprehensive assessment…” A review of CR’s was conducted on 7/9/2025 starting at approximately 3 pm, and again on 7/10/25 starting at 9:00 AM. The Start of Care (SOC) and CMS-485 Home Health and Certification Period (CP) are shown below. CR#3 SOC 1/15/25, indicated that the first comprehensive assessment was completed on 1/23/25, for CP from 1/15/25 to 3/15/25, which was not completed within the first 5 days of start of care. An interview conducted with the administrator, CEO and DON on 7/11/25 starting at 4 pm confirmed the above findings.”

“Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient’s status, and must include, at a minimum, the following information: (1) The patient’s current health, psychosocial, functional, and cognitive status; This Element is not met as evidenced by: Based on a review of agency policy, a review of patient clinical records (CR), and an interview with the agency’s administrator, Chief Executive Officer (CEO) and director of nursing (DON), the agency failed to ensure the comprehensive assessment must accurately reflect the patient’s status, and must include, at a minimum, the following information: (1) The patient’s current health, psychosocial, functional, and cognitive status for one (1) of seven (7) CR reviewed: CR#3. Findings include: A review of agency’s policies was conducted on 7/11/25 starting at 3 pm. A policy titled, “PAHH1.19 – OUTCOME AND ASSESSMENT INFORMATION SET (OASIS) reads, “POLICY: The outcome and Assessment information set (OASIS) will be completed by a registered nurse at specific points in time all Medicare, Medicaid, private insurance and self-pay adult skilled home care clients. It will be then transmitted to CMS. PROCEDURE: … The time points are: 1. Start of care, 2. Resumption of care following an inpatient facility stay, 3. Recertification (within the last five days of each 60 day certification period), 4. Other follow-up: For example “Significant Change in Condition,” … 7. Death at home, 8. Discharge from Agency. All assessments, except transfer to inpatient facility and death at home, require an in-person encounter with the client during a home visit. Start of Care Assessment: All new clients admitted to home health services, regardless of payor, are to have the Start of Care assessment and the OASIS data set completed. The Agency Start of Care assessment questionnaire contains all required Medicare questions as well as other added questions to follow for a comprehensive client assessment… 2. Current clients that do not have the OASIS data set will be required to have the SOC assessment/OASIS data set completed using the following procedure: a. Current clients who are admitted to the hospital will have an interruption of service form completed. While the client is in an inpatient status, a discharge form is to be completed along with a discharge order. … Follow-up/Recertification (Within the last 5 days of each certification period): 1. All clients, regardless of payor type, will have the follow-up assessment of the OASIS data set questionnaire completed to allow for a comprehensive assessment. The Follow-up assessment will be part of the certification process. Discharge (not to an inpatient facility): 1. All client, regardless of the payor type, will have the discharge assessment of the OASIS data set questionnaire completed to allow for a comprehensive assessment…” A review of CR’s was conducted on 7/9/2025 starting at approximately 3 pm, on 7/10/25 starting at 9:00 AM and again on 7/11/25 starting at 8:30 am. The Start of Care (SOC) and CMS-485 Home Health and Certification Period (CP) are shown below. CR#3 SOC 1/15/25 CP 1/15/25-3/15/25 indicated that the first comprehensive assessment was completed on 1/23/25. The following assessment criteria were left blank: immunization, cardiovascular system including blood pressure and heart sounds, ear/nose/throat/mouth, respiratory status, endocrine, neuro/emotional/mental status. File contained a recertification comprehensive assessment completed on 6/3/25, for CP from 6/3/25 to 8/3/25, which was not completed within the last 5 days of the certification period. An interview conducted with the CEO, administrator, director of nursing on July 11, 2025 starting at 4 pm confirmed the above findings.”

“Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This Element is not met as evidenced by: Based on a review of agency policy, a review of patient clinical records (CR), and an interview with the agency’s administrator, Chief Executive Officer (CEO) and director of nursing (DON), the agency failed to ensure a comprehensive assessment was conducted the last 5 days of every 60 days beginning with the start-of-care date for two (2) of seven (7) CR reviewed: CR#1 and 3. Findings include: A review of agency’s policies was conducted on 7/11/25 starting at 3 pm. A policy titled, “PAHH1.19 – OUTCOME AND ASSESSMENT INFORMATION SET (OASIS) reads, “POLICY: The outcome and Assessment information set (OASIS) will be completed by a registered nurse at specific points in time all Medicare, Medicaid, private insurance and self-pay adult skilled home care clients. It will be then transmitted to CMS. PROCEDURE: … The time points are: 1. Start of care, 2. Resumption of care following an inpatient facility stay, 3. Recertification (within the last five days of each 60 day certification period), 4. Other follow-up: For example “Significant Change in Condition,” … 7. Death at home, 8. Discharge from Agency. All assessments, except transfer to inpatient facility and death at home, require an in-person encounter with the client during a home visit. Start of Care Assessment: All new clients admitted to home health services, regardless of payor, are to have the Start of Care assessment and the OASIS data set completed. The Agency Start of Care assessment questionnaire contains all required Medicare questions as well as other added questions to follow for a comprehensive client assessment… 2. Current clients that do not have the OASIS data set will be required to have the SOC assessment/OASIS data set completed using the following procedure: a. Current clients who are admitted to the hospital will have an interruption of service form completed. While the client is in an inpatient status, a discharge form is to be completed along with a discharge order. … Follow-up/Recertification (Within the last 5 days of each certification period): 1. All clients, regardless of payor type, will have the follow-up assessment of the OASIS data set questionnaire completed to allow for a comprehensive assessment. The Follow-up assessment will be part of the certification process. Discharge (not to an inpatient facility): 1. All client, regardless of the payor type, will have the discharge assessment of the OASIS data set questionnaire completed to allow for a comprehensive assessment…” A review of CR’s format was conducted on 7/9/2025 starting at approximately 3 pm, on 7/10/25 starting at 9:00 AM and again on 7/11/25 starting at 8:30 am. The Start of Care (SOC) and CMS-485 Home Health and Certification Period (CP) are shown below. CR#1 SOC 7/1/23, contains a recertification comprehensive assessment completed on 9/18/24, for CP 8/24/24 –10/22/24, which was not completed within the last 5 days of the certification period. CR#3 SOC 1/15/25, contains a recertification comprehensive assessment completed on 6/3/25, for CP 5/15/25 – 7/13/25, which was not completed within the last 5 days of the certification period. An interview conducted with the CEO, administrator, director of nursing on July 11, 2025 starting at 4 pm confirmed the above findings.”

“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 a review of agency policies, clinical records (CR), and an interview with the administrator, the agency failed to ensure that the individualized plan of care include the frequency and duration of visits, all medications and treatments for three (3) of seven (7) CRs reviewed: CR# 1, 2, and 3. Findings include: A review of agency policy was conducted on 7/11/25 approximately 3 pm. A policy titled, “PAHH3.2B – MEDICAITON MANAGEMENT” reads, “… I. GENERAL PROCEDURES. The administration of medications will be performed only in accordance with written and signed orders from the patient’s physician or allowed medical practitioner. 1. Order will be taken by a skilled nurse in either verbal or written form and can include (but is not limited to) the following information: … d. dosage to be administered, e. frequency of administration, f. route of administration, … 2. The nurse will routinely monitor all medications to determine the continued appropriateness of medications being administered to the patient. … 6. If a determination is made that the medication may no longer be appropriate, the physician or allowed medical practitioner will be contacted, and the necessary orders received. …. VIII. Controlled Substances: …3. Controlled substances may be given only with a physician or allowed medical practitioner’s order… 8. A nurse may accept a verbal order for narcotics from a physician or allowed medical practitioner. It MUST be confirmed by a written order (such as the signed verbal order). To continue the administration, orders must be renewed on the next HCFA 485 completed…” A policy titled, “PAHH3.5A – PHYSICIAN OR ALLOWED PRACTITIONER ORDERS” reads, “…PROCEDURE: 1. The patient’s individualized care plan is established, periodically reviewed, and signed by a Doctor of Medicine, osteopathy, or podiatry, or allowed practitioner acting within the scope of his or her state license, certification, or registration… 5. The plan of treatment must be in the chart within seven (7) days (per current Pennsylvania requirements) after admission to the agency and must include: specific orders and frequency of visits… 6. The plan of treatment shall be dated and signed by the physician or allowed practitioner and incorporated into the agency’s permanent record for the client within 30 days. … 11. The client’s plan of treatment shall be reviewed by the physician or allowed practitioner, in consultation with the agency’s professional personnel, at such intervals as the severity of the client’s condition requires, but not to exceed: 60 days for skilled care and non skilled home health aide services under Medicare Certification. 13. Each review of the plan of treatment shall contain the signature of the physician or allowed practitioner and the date of review…” A review of CR’s was conducted on 7/9/2025 starting at approximately 3 pm, on 7/10/25 starting at 9:00 AM and again on 7/11/25 starting at 8:30 am. The Start of Care (SOC) and CMS-485 Home Health and Certification Period (CP) are shown below. CR#1 SOC 7/1/23 contains 2 POCs (Plan of Care), CP from 7/1/23 to 8/29/23 and 4/29/25 to 8/10/25, which were not signed/reviewed by the physician. The POC, CP from 4/29/25 to 8/10/25, contained SN orders for RN and LPN services that reads: “LPN services 6 days a week. RN services 1 day a week…. The patient requires RN services six days a week and LPN services one day a week to address the following needs…” There was no duration of service indicated in the order for SN. The POC, CP from 4/29/25 to 8/10/25, contained the following medication orders that did not include frequency, dosage, route, location: 1.“Albuterol Sulfate 2MG/5ML syrup – 10 – mL/4MG – Duration of 10 days when pt is sick. PRN for 10 days when patient is sick – G tube. Med is to be crushed and mixed in 10 mL of water, then administered via the G-tube as per protocol. Treats or prevents bronchospasm in conditions like asthma, COPD, or respiratory infections. On Going.” This order lacks start and end dates, or measurable parameters for safe administration. 2.“Armodafinil Oral Tablet 150MG – 1 – tab (s) – Given.” CR#1 is diagnosed with dysphagia and NPO (nothing by mouth) status. File also contained the following medication verbal orders that weren’t signed by the physician: 1. “Discontinue Order: Effective Date: 7/30/24, … Medication: Rosuvastatin Calcium Oral Tablet 20 MG… thru g-tube… 1 Tab(s) Daily with dinner, start date: 6/24/24, end date: 7/30/24…” 2. “Order:… Effective Date: 4/2/24, … Escitalopram Oxalate Oral tablet 20 MG, … G tube, … 1 Tab(s) daily, Start Date: 4/2/24…” 3. Order: … Effective Date: 9/20/24, … Albuterol Sulfate 2MG/5ML syrup, … G-tube, take 10 ML/4MG by G-tube 10ML/4MG 4 times per day as needed for 10 days, Start Date: left blank, End Date: left blank…” CR#2 SOC 7/18/22, contain 3 POCs (plan of care), CPs: 3/15/23 to 5/13/23, 3/9/24 to 5/7/24, 2/9/25 to 5/9/25, which all 3 POCs were not signed by the physician and 3 POCs included the following medication orders: 1. “Lorazepam Oral Tablet 0.5 MG – 1 – Tab(s) – every 8 hours as needed – Oral – Ongoing – as needed for anxiety.” 2. “Oxycodone (Roxicodone) 10 MG tablet – 1 – tab – every 4 hours as needed – oral – Ongoing – Take 1 tablet by mouth every 4 hours as needed for pain.” 3. “Temazepam Oral Capsule 30 MG – 1 – Cap(s) – nightly – oral – Ongoing – Take nightly for sleep.” File contains 2 POCs, CP, 5/10/25 to 7/8/25 and 6/14/25 to 8/14/25, which 2 POCs were not signed by the physician and 2 POCs included the following medication orders: 1. “Lorazepam Oral Tablet 1 MG – 1 – Tab(s) – Every 6 hours PRN for anxiety management – oral – Administer 1 tablet orally every 6 hours…” 2. “Oxycodone (Roxicodone) 10 MG tablet – 1 Tab(s) – Every 4 hrs PRN to manage moderate to severe pain… administer 1 tablet orally every 4 hours as needed…” 3. “Temazepam Oral Capsule 30 MG – 1 – Cap(s) – Once daily at bedtime to manage insomnia – PRN to manage insomnia – oral – Administer 1 capsule orally at bedtime as needed…” There is no verbal order to discontinue “Lorazepam Oral Tablet 0.5 MG – 1 – Tab(s) – every 8 hours as needed – Oral – Ongoing – as needed for anxiety.” and to reflect change of Lorazepam medication dose and frequency. During home visit for CR#2 on 7/9/25, a medication administration record was reviewed. The document showed that the agency provided medication management for controlled substances including lorazepam, oxycodone and temazepam for following shifts: 6/8/25 7 pm to 7am, 6/9/25 7am to 7 pm, 6/9/25 7 pm to 7 am, 6/10/25 7 am to 7 pm, 6/10/25 7 pm to 7 pm, 6/11/25 7 am to 1 pm, 6/11/25 7 pm to 7 am, 6/12/25 7 am to 7 pm, 6/12/25 7 pm to 7 am, 6/13/25 7 am to 12 pm, 6/13/25 12 pm to 7 pm, 6/13/25 7 pm to 7 am, 6/14/25 7 am to 7 pm, 6/14/25 7 pm to 7 am, 6/15/25 7 am to 7 pm, 6/18/25 7 pm to 7 am, 6/19/25 7 am to 7 pm, 6/19/25 7 pm to 7 am, 6/20/25 7 am to 7 pm, 6/20/25 7 pm to 7 am… CR#3 SOC 1/15/25, contains 2 POC, CP 1/15/25 to 3/15/25 and 6/3/25 to 8/3/25, which the 2 POCs were not signed by the physician and the 2 POCs included a physician order that reads, “4 visits per 1 day from 1/15/2025, skilled nursing services 4 x a week (Saturday, Sunday, Tuesday, Wednesday).” There was no duration of service indicated in the order for SN. File did not contain documentation that the POC was reviewed and revised by physician every 60 days from 3/15/25 to 6/3/25. An interview conducted with the administrator, CEO and DON on 7/11/25 starting at 4 pm confirmed the above findings.”

“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 a review of agency’s policies, Clinical Records (CR) and an interview with the administrator, CEO and director of nursing, the agency failed to administer drugs, services, and treatments only as ordered by a physician or allowed practitioner for four (4) of seven (7) CRs reviewed: CR# 1, 2, and 3. Findings include: A review of agency’s policies was conducted on 7/11/25 staring at 3 pm. A policy titled, “PAHH3.2B – MEDICAITON MANAGEMENT” reads, “… I. GENERAL PROCEDURES. The administration of medications will be performed only in accordance with written and signed orders from the patient’s physician or allowed medical practitioner. 1. Order will be taken by a skilled nurse in either verbal or written form and can include (but is not limited to) the following information: … d. dosage to be administered, e. frequency of administration, f. route of administration, … 2. The nurse will routinely monitor all medications to determine the continued appropriateness of medications being administered to the patient. … 6. If a determination is made that the medication may no longer be appropriate, the physician or allowed medical practitioner will be contacted, and the necessary orders received. …. VIII. Controlled Substances: …3. Controlled substances may be given only with a physician or allowed medical practitioner’s order… 8. A nurse may accept a verbal order for narcotics from a physician or allowed medical practitioner. It MUST be confirmed by a written order (such as the signed verbal order). To continue the administration, orders must be renewed on the next HCFA 485 completed…” A policy titled, “PAHH3.5A – PHYSICIAN OR ALLOWED PRACTITIONER ORDERS” reads, “…PROCEDURE: 1. The patient’s individualized care plan is established, periodically reviewed, and signed by a Doctor of Medicine, osteopathy, or podiatry, or allowed practitioner acting within the scope of his or her state license, certification, or registration… 5. The plan of treatment must be in the chart within seven (7) days (per current Pennsylvania requirements) after admission to the agency and must include: specific orders and frequency of visits… 6. The plan of treatment shall be dated and signed by the physician or allowed practitioner and incorporated into the agency’s permanent record for the client within 30 days. … 11. The client’s plan of treatment shall be reviewed by the physician or allowed practitioner, in consultation with the agency’s professional personnel, at such intervals as the severity of the client’s condition requires, but not to exceed: 60 days for skilled care and non skilled home health aide services under Medicare Certification. 13. Each review of the plan of treatment shall contain the signature of the physician or allowed practitioner and the date of review…” A policy titled, “PAHH3.4 – CARE PLAN MANAGEMENT” reads, “…PROCEDURE: Patient Notification of Changes: … 5. Missed Visits: If the visit cannot be rescheduled, Agency staff will complete a Missed Visit Report and send a copy to the attending physician or allowed practitioner for due diligence. a. The Missed Visit Report will be placed in the patient’s chart….” A policy titled, “PAHH3.5B – VERBAL ORDER MANAGEMENT” reads, “… POLICY: Orders will be obtained from a licensed physician (or allowed practitioner) for care and services to be provided to home health patients. Orders to be taken only by professional, licensed home health personnel (registered nurse, licensed practical nurse, or qualified therapist)… PROCEDURE: …4. Verbal orders taken by the licensed practical nurse (LPN) will be reviewed and signed by a registered nurse. 5. A copy of the physician’s (or allowed practitioner’s) order will be kept in the clinical record… 8. Singed orders will be in the clinical record within 30 days of initiation of care or date of interim order, unless otherwise specified by applicable state law and regulation…” A policy titled, “PAHH1.18 – RECORDS MANAGEMENT” reads, “… PROCEDURE: Clinical Record Documentation: The agency maintains a confidential clinical record for each patient admitted to care period it includes the following information….2. Assessments: a. Each appropriate skilled professional who is active in a patient’s care is responsible for doing an assessment of the patient. B. an initial assessment is to be done on admission. A copy of the assessment is kept in the clinical record. The initial assessment documentation must be submitted within 48 hours after admission. a. This includes physical and the psychosocial assessment and home safety assessment. C. All additional reassessments are to be included in the patient record. D. All documentation will include a name and title of the clinician completing the assessment. 3. The physician or allowed practitioner orders: A. When indicated by agency policy, written physician or allowed practitioner orders are obtained and signed by the physician or allow the practitioner within the required timeline after admission to the agency. These orders are to be renewed as necessary and in accordance with agency policy. b. Changes in order that occur before the orders are renewed are to be documented in the clinical record and a written request is to be sent to obtain the orders in writing. These orders are to be signed by the physician or allow the practitioner within are required the time frame and the returned to the agency. When returned from the physician or allow the practitioner, the sign the orders are to be filed in the clinical record… All required documentation must be completed and in the patient record within fourteen (14) days of service delivery… STORAGE AND DISPOSAL OF RECORDS: the administrator (or alternate) is responsible to ensure that the record storage and disposal company is properly prepared to store and secure all records and are contracted with the agency to provide this service…” A review of CR’s was conducted on 7/9/2025 starting at approximately 3 pm, on 7/10/25 starting at 9:00 AM and again on 7/11/25 starting at 8:30 am. The Start of Care (SOC) and CMS-485 Home Health and Certification Period (CP) are shown below. CR#1 SOC 7/1/23 contains 2 POCs (Plan of Care), CP from 7/1/23 to 8/29/23 and 4/29/25 to 8/10/25, which were not signed/reviewed by the physician. The POC, CP from 4/29/25 to 8/10/25, states: “LPN services 6 days a week. RN services 1 day a week…. The patient requires RN services six days a week and LPN services one day a week to address the following needs. The file contained the following missed visits: During the week of 5/11/25, 6 RN visits were made, and 0 LPN visits made. During the week of 5/25/25, 6 RN visits were made, and 0 LPN visit was made. During the week of 6/1/25, 6 RN visits were made, and 0 LPN visit was made. During the week of 6/8/25, 6 RN visits were made, and 0 LPN visit was made. During the week of 6/15/25, 6 RN visits were made, and 0 LPN visit was made. During the week of 6/22/25, 6 RN visits were made, and 0 LPN visits made. There was no documentation that the physician was notified about the above missed visits, and there was no verbal order to update or discontinue the order. CR#2 SOC 7/18/22, contain 3 POCs (plan of care), CPs: 3/15/23 to 5/13/23, 3/9/24 to 5/7/24, 2/9/25 to 5/9/25, which all 3 POCs were not signed by the physician and 3 POCs included the following medication orders: 1. “Lorazepam Oral Tablet 0.5 MG – 1 – Tab(s) – every 8 hours as needed – Oral – Ongoing – as needed for anxiety.” 2. “Oxycodone (Roxicodone) 10 MG tablet – 1 – tab – every 4 hours as needed – oral – Ongoing – Take 1 tablet by mouth every 4 hours as needed for pain.” 3. “Temazepam Oral Capsule 30 MG – 1 – Cap(s) – nightly – oral – Ongoing – Take nightly for sleep.” File contains 2 POCs, CP, 5/10/25 to 7/8/25 and 6/14/25 to 8/14/25, which 2 POCs were not signed by the physician and 2 POCs included the following medication orders: 1. “Lorazepam Oral Tablet 1 MG – 1 – Tab(s) – Every 6 hours PRN for anxiety management – oral – Administer 1 tablet orally every 6 hours…” 2. “Oxycodone (Roxicodone) 10 MG tablet – 1 Tab(s) – Every 4 hrs PRN to manage moderate to severe pain… administer 1 tablet orally every 4 hours as needed…” 3. “Temazepam Oral Capsule 30 MG – 1 – Cap(s) – Once daily at bedtime to manage insomnia – PRN to manage insomnia – oral – Administer 1 capsule orally at bedtime as needed…” There is no verbal order to discontinue “Lorazepam Oral Tablet 0.5 MG – 1 – Tab(s) – every 8 hours as needed – Oral – Ongoing – as needed for anxiety.” and to reflect change of Lorazepam medication dose and frequency. During home visit for CR#2 on 7/9/25, a medication administration record was reviewed. The document showed that the agency provided medication management for controlled substances including lorazepam, oxycodone and temazepam for following shifts: 6/8/25 7 pm to 7am, 6/9/25 7am to 7 pm, 6/9/25 7 pm to 7 am, 6/10/25 7 am to 7 pm, 6/10/25 7 pm to 7 pm, 6/11/25 7 am to 1 pm, 6/11/25 7 pm to 7 am, 6/12/25 7 am to 7 pm, 6/12/25 7 pm to 7 am, 6/13/25 7 am to 12 pm, 6/13/25 12 pm to 7 pm, 6/13/25 7 pm to 7 am, 6/14/25 7 am to 7 pm, 6/14/25 7 pm to 7 am, 6/15/25 7 am to 7 pm, 6/18/25 7 pm to 7 am, 6/19/25 7 am to 7 pm, 6/19/25 7 pm to 7 am, 6/20/25 7 am to 7 pm, 6/20/25 7 pm to 7 am… File contained the following verbal order that was not signed by the physician: Order stated, “VERBAL ORDER: … Date: 9/17/2022, On 9/17/22 start taking cefpodoxime (Vantin) 200 mg tablet. Take 1 tablet (200 mg) by mouth 2 (two) times a day for 10 days.” CR#3 SOC 1/15/25, contains 2 POC, CP 1/15/25 to 3/15/25 and 6/3/25 to 8/3/25, which the 2 POCs were not signed by the physician and the 2 POCs included a physician order that reads, “4 visits per 1 day from 1/15/2025, skilled nursing services 4 x a week (Saturday, Sunday, Tuesday, Wednesday).” There was no duration of service indicated in the order for SN. The file contained the following missed visits: During the week of 1/15/25, no skilled nursing visits were made. During the week of 1/19/25, no skilled nursing visits were made. During the week of 1/26/25, no skilled nursing visits were made on Saturday and Sunday; total skilled nursing visit: 2 of 4 per week. During the week of 3/9/25, no skilled nursing visits were made on Sunday. File did not contain missed visit documentation regarding the above missed visits. There was no documentation that the physician was notified about the above missed visits. The file did not contain documentation that the POC was reviewed and revised by physician every 60 days from 3/15/25 to 6/3/25. An interview conducted with the administrator, CEO and DON on 7/11/25 starting at 4 pm confirmed the above findings.”

“Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA’s internal policies. (4) 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, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA’s internal policies. This Element is not met as evidenced by: Based on a review of clinical records (CR), agency’s policies and an interview with the administrator, Chief Executive Officer (CEO) and director of nursing (DON), the home health agency failed to ensure that (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA’s internal policies; (4) 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, date, and time 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 for two (2) of seven (7) CR’s reviewed: CR# 1 and 2. Findings include: A review of agency’s policies was conducted on 7/11/25 starting at 3 pm. A policy titled, “PAHH3.5B – VERBAL ORDER MANAGEMENT” reads, “… POLICY: Orders will be obtained from a licensed physician (or allowed practitioner) for care and services to be provided to home health patients. Orders to be taken only by professional, licensed home health personnel (registered nurse, licensed practical nurse, or qualified therapist)… PROCEDURE: …4. Verbal orders taken by the licensed practical nurse (LPN) will be reviewed and signed by a registered nurse. 5. A copy of the physician’s (or allowed practitioner’s) order will be kept in the clinical record… 8. Singed orders will be in the clinical record within 30 days of initiation of care or date of interim order, unless otherwise specified by applicable state law and regulation…” A review of CR’s was conducted on 7/9/2025 starting at approximately 3 pm, and again on 7/10/25 starting at 9:00 AM. The Start of Care (SOC) and CMS-485 Home Health and Certification Period (CP) are shown below. CR#1 SOC 7/1/23, contained the following verbal orders that weren’t signed by the physician: 1. Order stated, “Discontinue Order: Effective Date: 7/30/24, … Medication: Rosuvastatin Calcium Oral Tablet 20 MG… thru g-tube… 1 Tab(s) Daily with dinner, start date: 6/24/24, end date: 7/30/24…” 2. Order stated, “Order:… Effective Date: 4/2/24, … Escitalopram Oxalate Oral tablet 20 MG, … G tube, … 1 Tab(s) daily, Start Date: 4/2/24…” 3. Order: … Effective Date: 9/20/24, … Albuterol Sulfate 2MG/5ML syrup, … G-tube, take 10 ML/4MG by G-tube 10ML/4MG 4 times per day as needed for 10 days, Start Date: left blank, End Date: left blank…” CR#2 SOC 7/18/22 File contained the following verbal order that wasn’t signed by the physician: Order stated, “VERBAL ORDER: … Date: 9/17/2022, On 9/17/22 start taking cefpodoxime (Vantin) 200 mg tablet. Take 1 tablet (200 mg) by mouth 2 (two) times a day for 10 days.” An interview conducted with the administrator, CEO and director of nursing on 7/11/25 starting at 4 pm confirmed the above findings.”

“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 a review of agency policy, a review of patient clinical records (CR), and an interview with the agency’s administrator, Chief Executive Officer (CEO) and director of nursing (DON), the agency failed to ensure 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 for two (2) of seven (7) CR reviewed: CR#1 and 3. Findings include: A review of agency’s policies was conducted on 7/11/25 starting at 3 pm. A policy titled, “PAHH1.19 – OUTCOME AND ASSESSMENT INFORMATION SET (OASIS) reads, “POLICY: The outcome and Assessment information set (OASIS) will be completed by a registered nurse at specific points in time all Medicare, Medicaid, private insurance and self-pay adult skilled home care clients. It will be then transmitted to CMS. PROCEDURE: … The time points are: 1. Start of care, 2. Resumption of care following an inpatient facility stay, 3. Recertification (within the last five days of each 60 day certification period), 4. Other follow-up: For example “Significant Change in Condition,” … 7. Death at home, 8. Discharge from Agency. All assessments, except transfer to inpatient facility and death at home, require an in-person encounter with the client during a home visit. Start of Care Assessment: All new clients admitted to home health services, regardless of payor, are to have the Start of Care assessment and the OASIS data set completed. The Agency Start of Care assessment questionnaire contains all required Medicare questions as well as other added questions to follow for a comprehensive client assessment… 2. Current clients that do not have the OASIS data set will be required to have the SOC assessment/OASIS data set completed using the following procedure: a. Current clients who are admitted to the hospital will have an interruption of service form completed. While the client is in an inpatient status, a discharge form is to be completed along with a discharge order. … Follow-up/Recertification (Within the last 5 days of each certification period): 1. All clients, regardless of payor type, will have the follow-up assessment of the OASIS data set questionnaire completed to allow for a comprehensive assessment. The Follow-up assessment will be part of the certification process. Discharge (not to an inpatient facility): 1. All client, regardless of the payor type, will have the discharge assessment of the OASIS data set questionnaire completed to allow for a comprehensive assessment…” A review of CR’s format was conducted on 7/9/2025 starting at approximately 3 pm, on 7/10/25 starting at 9:00 AM and again on 7/11/25 starting at 8:30 am. The Start of Care (SOC) and CMS-485 Home Health and Certification Period (CP) are shown below. CR#1 SOC 7/1/23, contains a recertification comprehensive assessment completed on 9/18/24, for CP 8/24/24 –10/22/24, which was not completed within the last 5 days of the certification period. CR#3 SOC 1/15/25 contains a recertification comprehensive assessment completed on 6/3/25, for CP 5/15/25 – 7/13/25, which was not completed within the last 5 days of the certification period. An interview conducted with the CEO, administrator, director of nursing on July 11, 2025 starting at 4 pm confirmed the above findings.”

“A qualified HH aide successfully completed: CFR(s): 484.80(a)(1)(i-iv) A qualified home health aide is a person who has successfully completed: (i) A training and competency evaluation program as specified in paragraphs (b) and (c) respectively of this section; or (ii) A competency evaluation program that meets the requirements of paragraph (c) of this section; or (iii) A nurse aide training and competency evaluation program approved by the state as meeting the requirements of §483.151 through §483.154 of this chapter, and is currently listed in good standing on the state nurse aide registry; or (iv) The requirements of a state licensure program that meets the provisions of paragraphs (b) and (c) of this section. This Element is not met as evidenced by: Based on a review of agency policy, home health aide personnel files (PF) and an interview with the administrator, CEO and director of nursing, the agency did not ensure that the home health aide complete a training and competency program for two (2) of two (7) home health aide PF reviewed: PF# 4 and 7. Findings include: A review of agency’s policies was conducted on 7/11/25 starting at 3 pm. A policy titled, “PAHH2.6 – AGENCY ORIENTATION” reads, “POLICY: In accordance with regulations and accreditation standards, the Agency has established and implemented a comprehensive orientation program for new employees… PURPOSE: …To assess clinical skill levels, competency levels, and other capabilities of all new staff members. PROCEDURE: 1. The Administrator will ensure that every new staff member participates in the orientation program. 2. The supervising nurse (clinical director) will be oriented to the agency, using the orientation checklist, by the Administrator or qualified designee… 7. Field staff, all disciplines, will complete competency assessment as part of on-boarding, and on an annual basis, using the appropriate assessment tools (per discipline referenced in the index)…” A position description for Home Health Aide (HHA) was conducted on 7/11/25 at approximately 3 pm. It reads, “… POSITION PREREQUISITES AND QUALIFICATIONS: …2. Must successfully complete required training, meeting the Medicare standards. 3. Must be CPR Certified per agency policy…” A review of Personnel Files (PF) was conducted on 7/10/25 starting at 12:40 pm. Date of Hire (DOH) is indicated below. PF#4 DOH 6/1/23, did not contain evidence of a minimum of 75 hours of classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. PF#7 DOH 7/16/16, did not contain evidence of a minimum of 75 hours of classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. PF did not contain evidence of competency evaluation by observing an aide’s performance of the task with a patient or pseudo-patient. An interview conducted with the administrator, CEO and director of nursing on 7/11/25 starting at 4 pm confirmed the above findings.”

“Classroom and supervised practical training CFR(s): 484.80(b)(1) Home health aide training must include classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. Classroom and supervised practical training must total at least 75 hours. This Element is not met as evidenced by: Based on a review of agency policy, home health aide personnel files (PF) and an interview with the administrator, CEO and director of nursing, the agency failed to ensure the following: The home health aide completed a minimum of 75 hours of classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse for two (2) of two (7) home health aide PF reviewed: PF# 4 and 7. A home health aide competency evaluation by observing an aide’s performance of the task with a patient or pseudo-patient and by written examination, oral examination, or after observation of a home health aide with a patient, or with a pseudo-patient as part of a simulation for one (1) of two (2) home health aide PF reviewed: PF# 7. Findings include: A review of agency’s policies was conducted on 7/11/25 starting at 3 pm. A policy titled, “PAHH2.6 – AGENCY ORIENTATION” reads, “POLICY: In accordance with regulations and accreditation standards, the Agency has established and implemented a comprehensive orientation program for new employees… PURPOSE: …To assess clinical skill levels, competency levels, and other capabilities of all new staff members. PROCEDURE: 1. The Administrator will ensure that every new staff member participates in the orientation program. 2. The supervising nurse (clinical director) will be oriented to the agency, using the orientation checklist, by the Administrator or qualified designee… 7. Field staff, all disciplines, will complete competency assessment as part of on-boarding, and on an annual basis, using the appropriate assessment tools (per discipline referenced in the index)…” A position description for Home Health Aide (HHA) was conducted on 7/11/25 at approximately 3 pm. It reads, “… POSITION PREREQUISITES AND QUALIFICATIONS: …2. Must successfully complete required training, meeting the Medicare standards. 3. Must be CPR Certified per agency policy…” A review of Personnel File (PF) was conducted on 7/10/25 starting at 12:40 pm. Date of Hire (DOH) is indicated below. PF#4 DOH 6/1/23, did not contain evidence of a minimum of 75 hours of classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. PF#7 DOH 7/16/16, did not contain evidence of a minimum of 75 hours of classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. PF did not contain evidence of competency evaluation by observing an aide’s performance of the task with a patient or pseudo-patient. An interview conducted with the administrator, CEO and director of nursing on 7/11/25 starting at 4 pm confirmed the above findings.”

“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 a review of Internet Quality Improvement and Evaluation System (IQIES) report, agency’s policies, patient clinical records (CR), personnel files (PF), home visit observation, and an interview with the agency’s administrator, Chief Executive Officer (CEO) and director of nursing (DON), the agency failed to ensure that administrator (ii) be responsible for all day-to-day operations of the HHA. Findings include: A review of agency’s policies was conducted on 7/11/25 staring at 3 pm. A Policy titled, “POSITION DESCRIPTION – ADMINISTRATOR” reads, “DUTIES OF THE POSITION: The home health administrator will supervise clinical staff members who provide medical treatment to in-home patients, as well as employee perform administrative and operational support functions…KEY RESPONSIBILITITIES include the following. Other duties maybe assigned. 1. Plans, organizes, directs and evaluate operations to ensure the provision of adequate and appropriate care and services. 2. Ensures that skilled and non-skilled health care services are furnished and are under the supervision and direction of an appropriate clinical manager or qualified designee. 3. Directs the implementation of service goals and objectives and develops standards that ensure the delivery of safe and effective services to clients and families. 3. Consults with the clinical manger and other staff regarding clients or families. 5. Assures agency compliance with federal, state, and accreditation rules and regulations. 6. Assures compliance with agency policies and procedures…” A policy titled, “PAHH1.19 – OUTCOME AND ASSESSMENT INFORMA`TION SET (OASIS) reads, “POLICY: The outcome and Assessment information set (OASIS) will be completed by a registered nurse at specific points in time all Medicare, Medicaid, private insurance and self-pay adult skilled home care clients. It will be then transmitted to CMS. PROCEDURE: … The time points are: 1. Start of care, 2. Resumption of care following an inpatient facility stay, 3. Recertification (within the last five days of each 60 day certification period), 4. Other follow-up: For example “Significant Change in Condition,” … 7. Death at home, 8. Discharge from Agency. All assessments, except transfer to inpatient facility and death at home, require an in-person encounter with the client during a home visit. Start of Care Assessment: All new clients admitted to home health services, regardless of payor, are to have the Start of Care assessment and the OASIS data set completed. The Agency Start of Care assessment questionnaire contains all required Medicare questions as well as other added questions to follow for a comprehensive client assessment… 2. Current clients that do not have the OASIS data set will be required to have the SOC assessment/OASIS data set completed using the following procedure: a. Current clients who are admitted to the hospital will have an interruption of service form completed. While the client is in an inpatient status, a discharge form is to be completed along with a discharge order. … Follow-up/Recertification (Within the last 5 days of each certification period): 1. All clients, regardless of payor type, will have the follow-up assessment of the OASIS data set questionnaire completed to allow for a comprehensive assessment. The Follow-up assessment will be part of the certification process. Discharge (not to an inpatient facility): 1. All client, regardless of the payor type, will have the discharge assessment of the OASIS data set questionnaire completed to allow for a comprehensive assessment…” A review of IQIES “HHA (home health agency) Activity Report” was conducted on 7/7/25 at 9 am. The report period was set from 1/1/22 to 7/7/25. A review of CR’s was conducted on 7/9/2025 starting at approximately 3 pm, on 7/10/25 starting at 9:00 AM and again on 7/11/25 starting at 8:30 am. The Start of Care (SOC) and CMS-485 Home Health and Certification Period (CP) are shown below. CR#1 SOC 7/1/23, IQIES report shows agency submitted 2 recertification OASIS reports on 5/14/25 and 6/17/25. With the exception of the above 2025 2 recertification OASIS, the CR did not contain any other recertification/OASIS reports since the SOC of 7/1/23. CR#7 SOC 8/15/21, discharge date 5/16/22, IQIES report shows agency submitted 1 start of care OASIS report on 10/4/22 and 1 recertification OASIS report on 10/4/22. The CR did not contain any other OASIS reporting for recertification or discharge. A policy titled, “PAHH2.6 – AGENCY ORIENTATION” reads, “POLICY: In accordance with regulations and accreditation standards, the Agency has established and implemented a comprehensive orientation program for new employees… PURPOSE: …To assess clinical skill levels, competency levels, and other capabilities of all new staff members. PROCEDURE: 1. The Administrator will ensure that every new staff member participates in the orientation program. 2. The supervising nurse (clinical director) will be oriented to the agency, using the orientation checklist, by the Administrator or qualified designee… 7. Field staff, all disciplines, will complete competency assessment as part of on-boarding, and on an annual basis, using the appropriate assessment tools (per discipline referenced in the index)…” A position description for Home Health Aide (HHA) reads, “… POSITION PREREQUISITES AND QUALIFICATIONS: …2. Must successfully complete required training, meeting the Medicare standards. 3. Must be CPR Certified per agency policy…” A review of Personnel File (PF) was conducted on 7/10/25 starting at 12:40 pm. Date of Hire (DOH) is indicated below. PF#4 DOH 6/1/23, did not contain evidence of a minimum of 75 hours of classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. File contains direct care worker staff training records. PF#7 DOH 7/16/16 did not contain evidence of a minimum of 75 hours of classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. PF did not contain evidence of competency evaluation by observing an aide’s performance of the task with a patient or pseudo-patient. File contains Direct Care Worker competency test and job description. File contains direct care worker staff training records. On 7/7/25 at approximately 1 pm, agency’s CEO stated that agency has a census of 5 patients under the home health agency license: 4 patient killed nursing and 1 unskilled patient. On 7/9/25, during home visit, surveyor found that agency is providing direct care worker services to CR#5 via OLTL (Office of Long Term Living) waiver under the agency’s home care agency license ( license number 27213601).. On 7/11/25, approximately at 4 pm, an interview with agency’s administrator, CEO and director of nursing stated that agency do not currently have patients receiving home health aide services. A review of CR#5 revealed that there is no order or physician referral for providing home health aide services. An interview with the agency’s administrator, Chief Executive Officer (CEO) and director of nursing (DON) on 7/11/25 starting at 4 pm revealed that agency’s previous DON resigned abruptly in 2024 (date unknown).”

“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 a review of clinical records (CR), agency’s policiess, and an interview with the administrator, Chief Executive Officer (CEO) and director of nursing (DON), the agency failed the following:(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 for two (2) of seven (7) CR reviewed: CR# 6 and 7. Findings include: A review of agency’s policies was conducted on 7/11/25 staring at 3 pm. A policy titled, “PAHH3.3 – PAITENT CARE GUIDELINE” reads, “… Completion of Discharge Records: To verify closure of inactive records, all clinical records will be completed within 10 days of discharge as follows: 1. The clinical record of a discharge a patient is fully completed, including a discharge summary in 10 working days. 2. Each clinical record is completed within 10 working days and filed. The record will be maintained as outlined in policy #2.9, clinical record management. Interruption of Services: when an interruption of services occurs during a patient’s certification. The comma a note is to be completed and placed it in the clinical record with previous progress notes to clarify why visits have not occurred. A copy will also be sent to the attending physician to indicate due diligence. This will apply to instances in which the patient services have been interrupted…” A review of CR’s was conducted on 7/9/2025 starting at approximately 3 pm, on 7/10/25 starting at 9:00 AM and again on 7/11/25 starting at 8:30 am. The Start of Care (SOC) and CMS-485 Home Health and Certification Period (CP) are shown below. CR#6 SOC 5/14/21, discharge date unknown, contains a discharge assessment completed on 1/25/24 but date of discharge is left blank. The last skilled visit note for CR#6 was on 12/24/23. File does not contain evidence that discharge summary was sent to the primary care practitioner or other health care professional. CR#7 SOC 8/15/21, discharge 5/16/22, does not contain evidence that discharge summary was sent to the primary care practitioner or other health care professional. An interview conducted with the administrator, CEO and DON on 7/11/25 starting at 4 pm confirmed the above findings.”