Every finding on record at Aimm Home Healthcare, Inc

On 3/25/25 through 3/28/25, the Michigan Department of Licensing and Regulatory Affairs conducted a recertification survey at Aimm Home Healthcare. The agency was found to be out of compliance with the requirements for the Conditions of Participation at 42 CFR 484.102, Emergency Preparedness.

Development of EP Policies and Procedures CFR(s): 484.102(b) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [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. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility 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 annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization 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 address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility 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. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop emergency preparedness policies and procedures based on the emergency plan and risk assessment, resulting in the potential for an unprepared agency response in the event of an actual emergency. Findings include: The agency’s emergency preparedness (EP) binder was reviewed on 3/26/25. Upon review of the information, it was determined the agency failed to include policies and procedures to outline how the agency would respond to the emergencies identified in the hazard vulnerability assessment. During an interview with the Administrator (ADM) and Clinical Manager (CM) on 3/28/25 at 9:25 AM, ADM and CM stated they did not have any specific policies and procedures regarding EP and acknowledged the findings.

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 record review and interview, the agency failed to ensure the emergency plan was tested annually; and failed to ensure participation in a full-scale or facility based functional exercise every 2 years, resulting in the potential for an unprepared agency response in the event of an actual emergency. Findings include: The agency’s emergency preparedness (EP) binder was reviewed on 3/26/25. Upon review of the information, it was noted the agency completed a tabletop exercise in 2024, however, there was no evidence of exercises performed in 2022 or 2023. Additionally, a document located in the binder that outlined EP details (not titled or dated) stated, “1. Agency management staff will test disaster response yearly….”. It also stated, “2. The Agency will participate in a full-scale exercise that is community-based or an individual facility-based exercise when a community-based exercises is not accessible AND conduct an additional exercise that may include a second full-scale community or facility-based exercise or a tabletop exercise annually.” During an interview with the Administrator (ADM) and Clinical Manager (CM) on 3/28/25 at 9:25 AM, CM stated they also completed a tabletop exercise in 2023 but recently found out it was supposed to be a full-scale or facility based functional exercise, so she removed the exercise from the binder. CM was unable to provide evidence this exercise occurred. Additionally, CM was also unable to provide evidence of an exercise for 2022. CM and ADM acknowledged the findings at the time of interview.

A Medicare recertification was conducted on 3/25/25 through 3/28/25 by the Michigan Department of Licensing and Regulatory Affairs at: Aimm Home Healthcare 4086 Rochester Rd. Suite 204 Troy, MI 48085 At the time of the survey, the agency did not operate any branch offices or subunits. At the time of the survey, the agency’s active census was 3. Attempt was made to conduct home visits for all 3 current patients however one did not provide consent. Clinical records reviewed for this survey included 2 records with home visits, 1 active record without a home visit, and 4 discharge records for a total of 7 records. At the conclusion of the survey, this agency was determined to be out of compliance with the Conditions of Participation at 42 CFR 484 Home Health Services. As a result of the identified noncompliance, the agency is prohibited for 2 years from offering a Home Health Aide training and competency evaluation or a competency evaluation program as specified in 42 CFR §484.80(f)(3).

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient was informed about the frequency of visits for skilled services in 6 (P-1, 3, 4, 5,6, and 7) out of 7 sample records reviewed resulting in a lack of documentation that the patient was aware of visit frequency and the potential that the patient right to be informed was not provided. Findings include: P-1: This 85-year-old patient was admitted this home health agency on 3/20/25 with the diagnoses of chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), and type II diabetes. During record review on 3/26/25, it was noted the physical therapy initial evaluation dated 3/23/25 indicated the patient would be seen 1-2 times a week for 8 weeks. Additionally, it was noted the consent form signed by the patient at the start of care also indicated a frequency of 1-2 times a week for 8 weeks. It was unclear whether the patient would be receiving 1 or 2 visits per week. The agency failed to inform the patient of the care and services that were to be furnished. P-3: This 90-year-old patient was admitted to this home health agency on 11/9/24 with the diagnoses of acute bronchitis, chronic obstructive pulmonary disease (COPD), and a stage 2 pressure ulcer of her left buttock. During record review on 3/27/25, it was noted the physical therapy evaluation dated 11/12/24 indicated the patient would be seen 1-2 times a week for 8 weeks. Additionally, it was noted the consent form signed by the patient at the start of care also indicated a frequency of 1-2 times a week for 8 weeks. It was unclear whether the patient would be receiving 1 or 2 visits per week. The agency failed to inform the patient of the care and services that were to be furnished. Findings were reviewed with and acknowledged by the Administrator (ADM) and Clinical Manager (CM) during an interview on 3/28/25 at 3:30 PM. P-4: This 86-year-old was admitted to the agency on 12/24/24 with diagnoses including gastrointestinal bleed; atrial fibrillation (a heart arrythmia); and high blood pressure. The medical record was reviewed on 3/28/25. During review, it was noted that a “Proposed Frequency” for skilled nursing (SN) and physical therapy (PT) services was provided to the patient on 12/24/24 and included expected SN visits of 1-2 times per week and PT visits of 1-2 times per week. There was no explanation of how or when either service (SN or PT) would determine if visits should be 1 or 2 times each week. There was no evidence that the patient was informed about what conditions would cause one SN and/or one PT visit per week versus two. P-5: This 82-year-old was admitted to the agency on 7/13/24 with diagnoses including type 2 Diabetes; high blood pressure; and unsteadiness while on feet. The medical record was reviewed on 3/28/24. During review, it was noted that a “Proposed Frequency” for PT services was provided to the patient on 7/13/24 and included expected PT visits of 1-2 times per week. There was no explanation of how or when the PT would determine if visits should be 1 or 2 times each week. There was no evidence that the patient was informed about what conditions would cause one visit per week versus two. P-6: This 93-year-old was admitted to the agency on 2/17/25 with diagnoses including pressure ulcers of the sacral region, back, and left heel. The medical record was reviewed on 3/27/25. During review, it was noted that a “Proposed Frequency” for SN services was provided to the patient on 2/17/25 and included expected SN visits of 1-2 times per week. There was no explanation of how or when the SN would determine if visits should be 1 or 2 times each week. There was no evidence that the patient was informed about what conditions would cause one visit per week versus two. P-7: This 94-year-old was admitted to the agency on 3/10/25 with diagnoses including pressure ulcer of right buttock; hypertensive heart disease (heart problems due to high blood pressure); and kidney disease. The medical record was reviewed on 3/26/25. During review, it was noted that a “Proposed Frequency” for SN and PT services was provided to the patient on 3/10/25 and included expected SN visits of 1-2 times per week and PT visits of 1-2 times per week. There was no explanation of how or when either service (SN or PT) would determine if visits should be 1 or 2 times each week. There was no evidence that the patient was informed about what conditions would cause one SN and/or PT visit per week versus two. These findings were reviewed and acknowledged during interview on 3/28/25 at 2:30 p.m. by the agency Administrator (ADM) and the Clinical Manager (CM).

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 record review and interview the agency failed to ensure the initial assessment to determine immediate care and support needs of the patient was performed within 48 hours of physician referral, patient return home, or physician (or allowed practitioner) ordered start of care date in 5 (P-2, 3, 4, 6, and 7) out of 7 sample records reviewed resulting in unidentified initial needs of the patient and potentially resulting in poor patient outcomes. Findings include: **Policy titled "Comprehensive Assessment" (revised 4/2017) stated, "6. When the RN (registered nurse) is the Case Manager, the RN must make the first visit within 48 hours of the referral unless otherwise specified by the physician," and "7. If Physical or Speech Therapy is the Case Manager, they must make their initial visit within 48 hours of the referral unless otherwise specified by the physician or per family request." It also stated, "8. Any discipline that does not make the initial visit within the specified time frame must make a notation in the patient's medical record that indicates why there was a delay in the start of care. The referring physician must be notified as soon as possible of both the delay and reason." P-2: This 78-year-old patient was admitted to this home care agency on 11/18/24 with the diagnoses of idiopathic gout, type II diabetes, and chronic kidney disease. During record review on 3/26/25, it was noted the referral from the physician was dated 11/14/24. Upon further review of the record, it was determined the initial assessment was performed by the registered nurse on 11/18/24 – 4 days after the date of referral. There was no indication of the reason for delay or of physician notification per policy. P-3: This 90-year-old patient was admitted to this home health agency on 11/9/24 with the diagnoses of acute bronchitis, chronic obstructive pulmonary disease (COPD), and a stage 2 pressure ulcer of her left buttock. During record review on 3/27/25, it was noted the referral from the physician was dated 10/29/24 and the patient was discharged home from sub-acute rehabilitation on 11/1/24. Upon further review of the record, it was determined the initial assessment was performed by the registered nurse on 11/9/24 – 8 days after the patient returned home. There was no indication of the reason for delay or of physician notification per policy. Findings were reviewed with and acknowledged by the Administrator (ADM) and Clinical Manager (CM) during an interview on 3/28/25 at 3:30 PM. P-4: This 86-year-old was admitted to the agency on 12/24/24 with diagnoses including gastrointestinal bleed; atrial fibrillation (a heart arrythmia); and high blood pressure. The medical record was reviewed on 3/28/25. During review, it was noted that the physician referral for home care was dated 12/11/24. The initial visit/comprehensive assessment was completed by the registered nurse (RN) on 12/24/24 (13 days later) with documentation included within stating that the verbal referral for home care was given on 12/11/24, and the patient’s most recent discharge date from an inpatient facility was on 12/11/24. During interview on 3/28/25 at 2:30 p.m., the Clinical Manager (CM) stated that there was a delay because the patient went to a rehab prior to receiving home health services. There was no documentation of another inpatient admission after 12/11/24 in medical record and a new start of care date was not obtained from the physician prior to 12/24/24. P-6: This 93-year-old was admitted to the agency on 2/17/25 with diagnoses including pressure ulcers of the sacral region, back, and left heel. The medical record was reviewed on 3/27/25. During review, it was noted that the physician referral for home care was dated 2/14/25. The initial assessment visit was completed by the RN on 2/17/25 (3 days later). There were no notes indicating the patient/family requested a delay in the start of care. P-7: This 94-year-old was admitted to the agency on 3/10/25 with diagnoses including pressure ulcer of right buttock; hypertensive heart disease (heart problems due to high blood pressure); and kidney disease. The medical record was reviewed on 3/26/25. During review, it was noted that the physician referral order for home care was transmitted via fax to the agency on 3/6/25. The initial assessment visit was made by the RN on 3/10/25 (4 days later). There were no notes indicating the patient/family requested a delay in the start of care. These findings were reviewed and acknowledged during interview on 3/28/25 at 2:30 p.m. by the agency Administrator (ADM) and CM.

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 observation, record review, and interview, the agency failed to ensure the comprehensive assessment accurately reflected the patient’s current health status at the time of admission for 3 (P-1, 3, and 5) of 7 records reviewed, resulting in incomplete clinical information used to determine the needs of these patients and used to assist in developing the plan of care. Findings include: P-1: This 85-year-old patient was admitted this home health agency on 3/20/25 with the diagnoses of chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), and type II diabetes. During record review on 3/26/25, it was noted the Outcome and Assessment Information Set (OASIS) indicated the patient had “adequate” hearing. During a joint home visit with the physical therapist on 3/26/25 at 2:00 PM, it was observed the patient was very hard of hearing and required those speaking to her to move closer or talk louder. Upon further review of the OASIS, it was noted the patient was able to ambulate (walk) “With the use of a one-handed device (or example, cane, single crutch, hemi-walker), able to independently walk on even and uneven surfaces and negotiate stairs with or without railings.” Further down on the form, it was noted the patient’s prior level of functioning for “Indoor Mobility (Ambulation)” was, “Dependent – A helper completed all the activities for the patient.” During the joint home visit with the physical therapist on 3/26/25 at 2:00 PM, the patient's son was asked if his mom was dependent for walking prior to starting with home care. The patient's son stated his mom has always been able to walk with assistance and was never fully dependent. Upon review of the medications listed in the OASIS, it was noted the medication “Basaglar” was labeled as an “Anti-hypertensive” (a medication used to treat high blood pressure). However, Basaglar is a type of injectable insulin used to treat diabetes. Due to being mislabeled, it was noted on the OASIS that “No injectable medications prescribed”, therefore, the patient’s ability to manage this medication was not assessed. It was also noted the OASIS indicated, “Yes – Issues found during review” under “Drug Regimen Review.” However, a hand-written medication profile in the paper record also dated 3/20/25 reported “No” to the statement, “E. Have potential adverse effects, significant drug interactions, duplicate/ineffective drug therapy and potential contraindications been identified?” The agency’s electronic medical record (EMR) indicated 2 severe drug interactions. The above information above is conflicting and does not provide a clear picture of the patient’s current or potential status. Additionally, it was noted that the sections labeled “Vital Signs” and “Cardiopulmonary” on the OASIS were left blank except for height. The comprehensive assessment failed to include complete information regarding the patient’s current status. P-3: This 90-year-old patient was admitted to this home health agency on 11/9/24 with the diagnoses of acute bronchitis, chronic obstructive pulmonary disease (COPD), and a stage 2 pressure ulcer of her left buttock. During record review on 3/27/25, it was determined the comprehensive assessment indicated the patient had one Stage 2 pressure ulcer, however, failed to include wound measurements, observations, or assessments. Additionally, the comprehensive assessment failed to include what wound care (if any) was done that day. Findings were reviewed with and acknowledged by the Administrator (ADM) and Clinical Manager (CM) during an interview on 3/28/25 at 3:30 PM. P-5: This 82-year-old was admitted to the agency on 7/13/24 with diagnoses including type 2 Diabetes; high blood pressure; and unsteadiness while on feet. The medical record was reviewed on 3/28/24. During review of the comprehensive assessment completed by the physical therapist (PT) on 7/13/24, it was noted that the primary diagnosis for home health was listed as type 2 Diabetes. The PT documented under the section of the comprehensive assessment called “Endocrine/Hematology” that the patient had “No problem” and did not select that the patient had diabetes or complete any related assessments including diet, insulin dose/frequency, blood sugar ranges, whether the patient checked blood sugars, any manifestations of the disease (hypo or hyperglycemia episodes), or any disease management problems. This comprehensive assessment did not accurately reflect the patient's current health status at the time of admission. This finding was reviewed and acknowledged during interview on 3/28/25 at 2:30 p.m. by the agency Administrator (ADM) and the Clinical Manager (CM).

Patient's needs CFR(s): 484.55(c)(4) The patient's medical, nursing, rehabilitative, social, and discharge planning needs; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the discharge planning needs of the patient were accurately reflected in the comprehensive assessment in 1 (P-6) of 7 sample records reviewed potentially resulting in unmet patient care needs upon discharge. Findings include: P-6: This 93-year-old was admitted to the agency on 2/17/25 with diagnoses including pressure ulcers of the sacral region, back, and left heel. The medical record was reviewed on 3/27/25. During review of the comprehensive assessment completed by the registered nurse (RN) on 2/17/25, it was noted that P-6 was chronically bed fast and unable to ambulate or be up in a chair, dependent on others for all activities of daily living, had a prior level of functioning as dependent on others, transferred with assistance of others with a Hoyer Lift (mechanical lifting device) and had co-morbidity of dementia. It was also noted in the comprehensive assessment that the RN documented that discharge plans were “discussed with patient” and discharge could be planned when: the patient returned to independent level of care (self-care), when the patient was knowledgeable about when to notify the physician, and when the patient was able to understand medication regime and care related to diagnoses. The patients discharge needs were not accurately reflected in the comprehensive assessment. This finding was reviewed and acknowledged during interview on 3/28/25 at 2:30 p.m. by the agency Administrator (ADM) and the Clinical Manager (CM).

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 record review and interview, the agency failed to ensure medication reconciliation was performed per policy and as documented in 2 (P-2 and 4) of 7 records reviewed, resulting in the potential to miss harmful medication reactions. Findings include: **Policy titled “Medication Reconciliation” (reviewed 11/2020) stated, “3. The admission professional will review the medication list with the physician/allowed practitioner, and confirm those medications that are to be continued or discontinued. The doses will be confirmed with the physician/allowed practitioner and changes will be noted on the medication profile, medication record in the patient’s home and on the Physician/allowed practitioner Plan of Care/485.” P-2: This 78-year-old patient was admitted to this home care agency on 11/18/24 with the diagnoses of idiopathic gout, type II diabetes, and chronic kidney disease. During record review on 3/26/25, it was determined the OASIS indicated, “Yes – Issues found during review” under “Drug Regimen Review.” Additionally, it was noted on the OASIS that the agency contacted “…a physician (or physician-designee) by midnight of the next calendar day and complete prescribed/recommended actions in response to the identified potential clinically significant medication issues.” The drug interaction report run by the agency's electronic medical record system identified 3 "severe" interactions. Upon further review of the record, it was noted the medication interaction report was stamped “faxed” by the agency on 11/22/24 – 4 days after the interactions were identified. There was no evidence of return communication with the physician on how to handle the drug interactions identified. Findings were reviewed with and acknowledged by the Administrator (ADM) and Clinical Manager (CM) during an interview on 3/28/25 at 3:30 PM. P-4: This 86-year-old was admitted to the agency on 12/24/24 with diagnoses including gastrointestinal bleed; atrial fibrillation (a heart arrythmia); and high blood pressure. The medical record was reviewed on 3/28/25. During review, it was noted that the patient’s medications included 6 severe drug interactions between 12 of the patient’s medications. The registered nurse (RN) completed the comprehensive assessment on 12/24/24 and included documentation that a medication review was completed, and issues were identified. The RN also marked (yes) that the physician had been notified of the severe interactions by midnight of the next calendar day (12/25/24). In the section of the comprehensive assessment titled “Summary Checklist” and under “Medication Status”, the RN failed to include what medication interactions were identified during drug review, or if those interactions were discussed with the physician and what the physicians response was. It is unclear if the RN discussed all 6 severe drug interactions with the physician at the time of admission. Additionally, it was noted that a “Drug Interaction” report was printed and in the patient’s paper chart. The 6 severe drug interactions were listed, and the report had a “Faxed” stamp with the date of 12/30/24 indicating that this patient’s severe drug interactions list was faxed to the physician office on 12/30/24 (6 days after admission). There was no physician signature on the drug interaction report. This finding was reviewed and acknowledged during interview on 3/28/25 at 2:30 p.m. by the agency Administrator (ADM) and the Clinical Manager (CM).

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 record review and interview, the agency failed to ensure individualized interventions and measurable goals for care were documented on the plan of care for 1 (P-2) of 7 sample records reviewed resulting in patients not receiving care specific to their individual needs and the potential for poor patient outcomes. Findings include: P-1: This 85-year-old patient was admitted this home health agency on 3/20/25 with the diagnoses of chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), and type II diabetes. During record review on 3/26/25, the following skilled nursing goals were noted on the plan of care: “Return to an independent lever of care (self-care)” “Able to remain in residence with assistance of primary caregiver/support from community agencies” “When patient knowledgeable about when to notify physician” [sic} “Able to understand medication regimen and care related to diagnoses” These goals lack measurable, patient-specific data to assess progress towards meeting them. Additionally, it was noted the plan of care failed to include diabetic supplies in the section for “DME (durable medical equipment) and Supplies.” P-3: This 90-year-old patient was admitted to this home health agency on 11/9/24 with the diagnoses of acute bronchitis, chronic obstructive pulmonary disease (COPD), and a stage 2 pressure ulcer of her left buttock. During record review on 3/27/25, it was determined the plan of care dated 11/9/24 failed to include wound care interventions or wound care supplies. Findings were reviewed with and acknowledged by the Administrator (ADM) and Clinical Manager (CM) during an interview on 3/28/25 at 3:30 PM.

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 record review and interview, the agency failed to ensure services and treatments were administered only as ordered by the physician or allowed practitioner in 4 (P-1, 2, 3, and 5) of 7 records reviewed, resulting in the potential for unauthorized services to be provide to the patient. Findings include: P-5: This 82-year-old was admitted to the agency on 7/13/24 with diagnoses including type 2 Diabetes; high blood pressure; and unsteadiness while on feet. The medical record was reviewed on 3/28/24. During review, it was noted that the physician referral contained orders for Occupational Therapy (OT) and Physical Therapy services. OT services were not initiated during the certification period (7/13/24-9/10/24). There was no documentation that the patient refused OT services. There was no physician order to discontinue OT services found in the medical record. This finding was reviewed and acknowledged during interview on 3/28/25 at 2:30 p.m. by the agency Administrator (ADM) and the Clinical Manager (CM). P-1: This 85-year-old patient was admitted this home health agency on 3/20/25 with the diagnoses of chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), and type II diabetes. During record review on 3/26/25, it was noted telephone/verbal order to start home care services was located in the paper chart and labeled “Continuing Patient Care/Oder for Home Health Care”. Upon further review of the referral, it was determined it was faxed to the doctor on 3/18/25 and was never by the physician. Therefore, the record did not contain physician approved orders to start home care services for this patient. P-2: This 78-year-old patient was admitted to this home care agency on 11/18/24 with the diagnoses of idiopathic gout, type II diabetes, and chronic kidney disease. During record review on 3/26/25, it was noted the referral was dated 11/14/24 and requested occupational therapy services only. Upon further review of the record, it was determined the registered nurse performed the initial assessment on 11/18/24. There were no orders in the record for skilled nursing services. Skilled nursing services were started without an order from the physician. During an interview with the Administrator (ADM) and Clinical Manager (CM) during an interview on 3/28/25 at 3:30 PM, CM stated she "talked to AJ" and he sent another referral, however, CM was unable to provide the referral for review. ADM and CM acknowledged the findings. P-3: This 90-year-old patient was admitted to this home health agency on 11/9/24 with the diagnoses of acute bronchitis, chronic obstructive pulmonary disease (COPD), and a stage 2 pressure ulcer of her left buttock. During record review on 3/27/25, it was noted the referral for home care (dated 10/21/24) ordered services from physical therapy, occupational therapy, skilled nursing, and home health aide. Upon further review of the record, it was noted the Outcome and Assessment Information Set (OASIS) indicated a home health aide was refused. It also indicated that new orders were not obtained to communicate the refusal to the physician. Additionally, it was noted occupational therapy never evaluated the patient. There was no indication of patient refusal or communication with the physician. Services were not provided per physician order. During further interview with ADM and CM on 3/28/25 at 3:30 PM, CM was asked why these services were not provided as ordered. CM stated P-3 lived in a group home she worked with often and stated those patients typically had caregivers to assist them in ADLs (activities of daily living). CM also stated she had discussed the case with ADM (who is also the physical therapist) and they both agreed the patient did not need occupational therapy or home health aide services. ADM and CM acknowledged this is not reflected in the record and was not properly communicated with the physician. CM also stated there was a verbal order attached in the electronic medical record that indicated the patient would only receive skilled nursing and physical therapy, however, there was no evidence of it being sent to or signed by the physician. ADM and CM acknowledged the findings at the time of interview.

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 record review and interview, the agency failed to ensure all verbal orders were authenticated and dated by the physician (or allowed practitioner) in 1 (P-4) of 7 sample records reviewed potentially resulting in the physician being unaware of all orders and poor patient outcomes. Findings include: On 3/28/25 at 10:00 a.m., request was made to the Administrator (ADM) and Clinical Manager (CM) for the agency policy regarding a timeframe of physician authentication of verbal orders. At 10:45 a.m., CM stated that they (the agency) did not have a policy regarding physician authentication time frame. ADM and CM both agreed that verbal orders need to be authenticated by the physician, but neither were aware of what the State required timeframe was and had not been actively pursuing authentication of verbal orders other than signature on the plan of care. P-4: This 86-year-old was admitted to the agency on 12/24/24 with diagnoses including gastrointestinal bleed; atrial fibrillation (a heart arrythmia); and high blood pressure. The medical record was reviewed on 3/28/25. During review, it was noted that a telephone verbal order for discharge was received by the physician on 2/8/25. The order had not been authenticated at the time of record review (48 days later). This finding was reviewed and acknowledged during interview on 3/28/25 at 2:30 p.m. by the agency Administrator (ADM) and CM.

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 interview and record review, the agency failed to develop a quality assessment and performance improvement program in 2023, 2024, and 2025 per agency policy (see G0642); failed to utilize data for the development of a Quality Assessment Performance Improvement Program for 2023, 2024, and 2025 (see G0644); failed to develop the Quality Assessment Performance Improvement Program for 2023, 2024, and 2025 included program activities focusing on high risk and problem prone areas (see G0646); and failed to develop a quality assessment performance improvement program that documented a performance improvement projects for 2023, 2024, and 2025 per agency policy (see G658), resulting in the agency’s inability to improve patient care, health outcomes, and agency performance for all patients who received care with the agency during the period of review. Findings include: The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR §484.65 Quality Assessment and Performance Improvement.

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 interview and record review, the agency failed to develop a quality assessment and performance improvement program for 2023, 2024, and 2025 per agency policy resulting in the inability of the agency to access their process of care, services, and operations for all patients admitted to the agency during the period of review. Findings include: Agency policy titled “Quality Assessment Improvement Plan”; Reviewed/Revision Date April 2022, was reviewed on 3/28/25. On page 1., it stated “The Agency’s Quality Assessment Performance Improvement Program systemically monitors, analyzes and improves its performance to improve patient outcomes…” On 3/28/25 at 9:30 a.m., request was made to the agency Administrator (ADM) and the Clinical Manager (CM) to review the agency's Quality Assessment Performance Improvement (QAPI) program documentation for 2023, 2024 and 2025. CM stated that she had a binder with some documents but that the QAPI binder was not put together and that she was trying to “work on it”. CM collected a binder from her work area and described it as the “QAPI binder”. The binder contained documents which were not incorporated into the binder but were paper clipped and in a pile inside of the binder. CM stated that she wanted to be honest, and she had not properly developed the agency QAPI program and had just started putting it together when survey entrance was confirmed. CM stated that it was her preference to withhold the QAPI materials from survey review and stated that there were no QAPI activities for review for the period requested.

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 interview, the agency failed to utilize data for the development of a Quality Assessment Performance Improvement Program for 2023, 2024, and 2025 resulting in the inability of the agency to identify opportunities of improvement in quality of patient care for all patients services by the agency in the period of review. Findings include: On 3/28/25 at 9:30 a.m., request was made to the agency Administrator (ADM) and the Clinical Manager (CM) to review the agency's Quality Assessment Performance Improvement (QAPI) program documentation. CM stated that the agency was currently not collecting QAPI data for monitoring the effectiveness of safety of services and quality of care or other opportunities of agency improvement. CM also stated that the agency is small and have few patients and that they (ADM and CM) are aware of situations going on with each patient. No QAPI documentation was provided for review.

Program activities CFR(s): 484.65(c) (1) The HHA's performance improvement activities must— (i) Focus on high risk, high volume, or problem-prone areas; (ii) Consider incidence, prevalence, and severity of problems in those areas; and (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This STANDARD is not met as evidenced by: Based on interview, the agency failed to develop the Quality Assessment Performance Improvement Program for 2023, 2024, and 2025 included program activities focusing on high risk and problem prone areas resulting in the agency’s inability to identify factors associated with significant health or safety issues for their patient population during the period of review. Findings include: On 3/28/25 at 9:30 a.m., request was made to the agency Administrator (ADM) and the Clinical Manager (CM) to review the agency's Quality Assessment Performance Improvement (QAPI) program documentation. CM stated that the agency currently did not have any QAPI program activities.

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 interview and record review, the agency failed to develop a quality assessment performance improvement program that documented a performance improvement projects for 2023, 2024, and 2025 per agency policy resulting in the agency’s inability to improve patient care, health outcomes, and agency performance for all patients who received care with the agency during the period of review. Findings include: Agency policy titled “Quality Assessment Improvement Plan”; Reviewed/Revision Date April 2022, was reviewed on 3/28/25. On page 1., it stated “The Agency will use the performance prioritization sheet to identify areas of improvement… This process will determine our Process Improvement Projects (PIP).” On 3/28/25 at 9:30 a.m., request was made to the agency Administrator (ADM) and the Clinical Manager (CM) to review the agency's Quality Assessment Performance Improvement (QAPI) program documentation. CM was not able to provide evidence of a performance improvement project for 2023, 2024, or 2025.

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 interview and record review, the agency failed to maintain an agency wide program for infection surveillance, identification, prevention and control as part of the Quality Assessment Performance Improvement program for 2023, 2024, and 2025 resulting in the potential for development and spread of infectious disease without agency awareness. Findings include: On 3/28/25 at 9:30 a.m., request was made to the agency Administrator (ADM) and the Clinical Manager (CM) to review the agency's Quality Assessment Performance Improvement (QAPI) program and Infection Control documentation. CM admitted at the time of request that the QAPI program was not currently maintaining an agency wide infection control program to identify, prevent, and control infectious diseases.

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 record review and interview, the agency failed to ensure skilled professionals provided ongoing assessment of patients in 3 (P-3, 5, and 6) of 7 records reviewed (see G706); failed to ensure skilled professionals provided services as outline in the plan of care in 3 (P-1, 2, and 6) of 7 records reviewed (see G710); failed to provide patient and caregiver education appropriate to the patient’s diagnoses and needs in 2 (P-5 and 6) of 7 sample records reviewed (see G0712); and failed to ensure skilled professionals prepared clinical notes as required per agency policy in 3 (P-1, 2, 4) of 7 records reviewed (see G716), resulting in the potential for poor patient outcomes. Findings include: The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care in a safe environment for the condition of participation of 42 CFR §484.75 Skilled Professional Services.

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 record review and interview, the skilled professional failed to ensure an ongoing assessment of the patient in 3 (P-3, 5, and 6) of 7 sample records reviewed resulting in the potential for unidentified needs. Findings include: P-5: This 82-year-old was admitted to the agency on 7/13/24 with diagnoses including type 2 Diabetes; high blood pressure; and unsteadiness while on feet. The medical record was reviewed on 3/28/24. The physical therapist (PT) completed the comprehensive assessment on 7/13/24 and documented that type 2 Diabetes was the primary diagnosis for home care. The plan of care orders included PT services only. The PT made 12 visits over a period of 8 weeks (7/13/24 through 9/1/24). None of the PT visit notes contained any assessments for this patients type 2 Diabetes. None of the visit notes included collaboration with another health care professional regarding type 2 Diabetes. This finding was reviewed and acknowledged during interview on 3/28/25 at 2:30 p.m. by the agency Administrator (ADM) and the Clinical Manager (CM). P-6: This 93-year-old was admitted to the agency on 2/17/25 with diagnoses including pressure ulcers of the sacral region, back, and left heel. The medical record was reviewed on 3/27/25. During review, it was noted that the registered nurse (RN) completed the comprehensive assessment on 3/27/25 and included measurements of 4 areas of concern on the skin. The areas of concern included: Sacral wound (left) measuring 4 centimeters (cm) x 3cm Sacral wound measuring 4cm x 3.5 cm Bruise on the patients back measuring 3 cm Red area on the left heel measuring 2cm x 2 cm The RN made 5 additional visits (once weekly) over the next 5 weeks (2/24/25 through 3/27/25). The RN visit notes for the 5 additional visits all included the exact same areas and measurements as listed on the comprehensive assessment. This finding was reviewed during interview on 3/28/25 at 2:30 p.m. with ADM) and CM. CM was the current RN in charge of the care for P-6. CM was queried if this patients areas of concern on the skin were unchanged for 5 weeks while under the care of this agency. CM stated that the measurements entered in RN visit notes were carried over from the previous weeks and acknowledged that ongoing assessment could not be determined from the visit notes entered. P-3: This 90-year-old patient was admitted to this home health agency on 11/9/24 with the diagnoses of acute bronchitis, chronic obstructive pulmonary disease (COPD), and a stage 2 pressure ulcer of her left buttock. During record review on 3/27/25, the following was noted regarding wound care on the daily skilled nursing notes: 11/12/24: The visit reason indicated “monitor vital signs, wound care.” On the chart in the section labeled “Wound Care Provided”, “redness” was reported next to wound #1 length and “left ankle” was reported next to wound #2 length. Additionally, the box next to “Wound cleaned (specify)” was checked, however, there were no further details regarding wound care provided that day. Under “Interventions/instructions”, the box for “Decubitis care” was also checked. 11/20/24: The visit reason indicated “monitor vital signs, wound care.” On the chart in the section labeled “Wound Care Provided”, “healed” was reported next to wound #1 length and wound #2 length. No additional wound care notes were found on this day. Under “Interventions/instructions”, the box for “Decubitis care” was also checked. There were no further details regarding wound care provided that day. 11/26/24: The visit reason indicated “monitor vital signs, wound care.” There was no information recorded in the chart under “Wound Care Provided”, however, the box next to “Wound cleaned (specify)” was checked. Under “Interventions/instructions”, the box for “Decubitis care” was also checked. There were no further details regarding wound care provided that day. 12/3/24: The visit reason indicated “monitor vital signs, wound care.” The section labeled “Wound Care Provided” was completely blank, however, “Decubitis care” was checked next to the box under “Interventions/Instructions.” There were no further details regarding wound care provided that day. 11/12/24: The visit reason indicated “monitor vital signs, wound care.” The box next to “Wound cleaned (specify)” under “Wound Care Provided” was checked. The box next to “Decubitis care” was also checked under “Interventions/Instructions.” There were no further details regarding wound care provided that day. Skilled nursing failed to provide evidence of ongoing assessment and treatment of the patient’s wounds. Findings were reviewed with and acknowledged by the Administrator (ADM) and Clinical Manager (CM) during an interview on 3/28/25 at 3:30 PM.

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 record review and interview, the agency failed to provide services ordered by the physician or allowed practitioner as indicated in the plan of care in 3 (P-1, 2, and 6) of 7 records reviewed, resulting in the potential for unmet care needs and poor patient outcomes. Findings include: P-1: This 85-year-old patient was admitted this home health agency on 3/20/25 with the diagnoses of chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), and type II diabetes. During preparation for a joint home visit with the physical therapist on 3/26/25, a printed plan of care was provided for review. Upon review of the printed plan of care dated 3/20/25, it was noted there was an order for skilled nursing to, “Administer Insulin.” There was no evidence in the record of skilled nursing administering insulin to this patient or parameters to follow regarding administration. The agency failed to ensure the patient received services as outlined in the plan of care. P-2: This 78-year-old patient was admitted to this home care agency on 11/18/24 with the diagnoses of idiopathic gout, type II diabetes, and chronic kidney disease. During record review on 3/26/25, it was noted the plan of care dated 11/18/24 indicated an order for skilled nursing to do, “Blood Glucose Monitoring 3xdaily and PRN (as needed.” [sic] There was no evidence in the record of skilled nursing reporting blood sugars 3 times per day for this patient. The agency failed to ensure the patient received services as outlined in the plan of care. During an interview with the Clinical Manager (CM) on 3/28/25 at 3:30 PM, CM was asked about the above interventions noted on the plans of care. CM stated they were written for the caregiver to follow; however, CM agreed that was unclear on the plan of care and was written as an order for skilled nursing to follow. The Administrator (ADM) was also present during the interview and acknowledged the findings. P-6: This 93-year-old was admitted to the agency on 2/17/25 with diagnoses including pressure ulcers of the sacral region, back, and left heel. The medical record was reviewed on 3/27/25. During review of the plan of care (POC) dated 2/17/25, it was noted in the section titled “Orders for Discipline and Treatments”, skilled nursing (SN) orders/treatments included “Cleanse peg tube site daily…”. Additionally, orders for wound care included “Change every other day and PRN [as needed]”. The SN frequency was listed as 1 time weekly for 8 weeks. The medical record reflected the SN frequency as ordered. The SN was not following the orders for daily peg tube care and wound care every other day as ordered in the POC. This finding was reviewed and acknowledged during interview on 3/28/25 at 2:30 p.m. by the agency Administrator (ADM) and CM.

Patient, caregiver, and family counseling CFR(s): 484.75(b)(4) Patient, caregiver, and family counseling; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to provide patient and/or caregiver education appropriate to the patient’s diagnoses and needs in 2 (P-5 and 6) of 7 sample records reviewed potentially resulting in lack of knowledge for the patient and/or caregiver, and poor patient outcomes. Findings include: P-5: This 82-year-old was admitted to the agency on 7/13/24 with diagnoses including type 2 Diabetes; high blood pressure; and unsteadiness while on feet. The medical record was reviewed on 3/28/24. During review of the plan of care (POC), it was noted that type 2 Diabetes was the primary diagnosis listed for this patient. It was also noted that the physical therapist (PT) was the only clinician ordered to see the patient between the dates of service (7/13/24 through 9/1/24). There was no documented patient education or counseling found in the medical record related to the management of the primary diagnosis of type 2 Diabetes. This finding was reviewed and acknowledged during interview on 3/28/25 at 2:30 p.m. by the agency Administrator (ADM) and CM. P-6: This 93-year-old was admitted to the agency on 2/17/25 with diagnoses including pressure ulcers of the sacral region, back, and left heel. The medical record was reviewed on 3/27/25. During review of the comprehensive assessment dated 2/17/25, it was noted that the patient was: Fed a liquid diet by the caregiver through a peg tube (tube inserted into stomach) 4 times daily Incontinent of bowel and bladder Chronically bed fast and unable to ambulate or be up in a chair Dependent on others for all activities of daily living Had co-morbidity of dementia Did not smoke During review of skilled nursing (SN) notes dated between 2/17/25 and 3/27/25, documentation of patient education was reviewed and include the following examples: On 2/24/25, the SN instructed the “patient” to always wash hands… before preparing food, especially raw meat or poultry… hanging a diaper… touching animal waste. On 3/11/25, the SN instructed the “patient” on relaxation techniques such as to sit or lie down and uncross legs and arms… physical exercise by moving body parts through a wide range of motion… having periods of rest between activities… instructed to not drink any caffeinated beverages... instructed to go to the bathroom and empty bladder before measuring blood pressure… sit in a comfortable position... control blood pressure with smoking cessation, eating a healthy diet, regular exercise. On 3/18/25, the SN instructed the “patients” [sic] on ways to prevent aspiration including placing food on the stronger side (right)… allow 30-minute rest periods before meals. These findings were reviewed during interview on 3/28/25 at 2:30 p.m. with ADM and CM. CM stated that the education entered in the medical record for this patient were options available to the clinician which are clicked and easily entered into the medical record and acknowledged that the education/instruction examples above were not specific to the patients’ diagnoses, needs, or abilities.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure skilled professionals prepared clinical notes as required per agency policy in 4 (P-1, 2, and 4) of 7 sample records reviewed resulting in a lack of patient care assessments and potential poor patient outcomes. Findings include: P-1: This 85-year-old patient was admitted this home health agency on 3/20/25 with the diagnoses of chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), and type II diabetes. During record review on 3/26/25, it was determined the skilled nursing visit note from 3/20/25 was not completed until 3/24/25 – 4 days after the visit. P-2: This 78-year-old patient was admitted to this home care agency on 11/18/24 with the diagnoses of idiopathic gout, type II diabetes, and chronic kidney disease. During record review on 3/26/25, it was determined the occupational therapy visit notes from 11/22/24, 11/29/24, and 12/6/24 were not completed until 12/20/24. It was also noted the occupational therapy visit note from 12/26/24 was note completed until 2/3/25. During an interview with the Administrator (ADM) and Clinical Manager (CM) on 3/28/25 at 3:30 PM, the late documentation issues were discussed. ADM and CM stated they have been “very busy” as it is just them running the agency, however, acknowledged the findings and stated they needed to “do better”. Agency policy titled “Client Care Records”; Rev. 8.07, was reviewed on 3/26/25. On the second page of the policy (page 602), it stated “All entries in the health record must be… 2. Recorded within 24 hours of the provision of service…” P-4: This 86-year-old was admitted to the agency on 12/24/24 with the diagnoses of a gastrointestinal bleed, atrial fibrillation (a heart arrythmia), and high blood pressure. During record review on 3/28/25, it was noted that the skilled (SN) nurse completed the start of care (SOC) comprehensive assessment on 12/24/25. The medical record also appeared to have an SN visit (which was assigned and not entered as missed) every week for 5 weeks after the SOC (12/30/24; 1/9/25; 1/18/25; 1/25/25; 1/31/25). There were no SN visit notes entered for the dates of the visits listed at the time of record review (over 14 weeks later). It was also noted during review that the physical therapy evaluation from 12/26/24 was not completed until 3/24/25 – 3 months after the visit occurred. Additionally, the physical therapy visit notes dated 12/28/24, 1/2/25, 1/4/25, 1/7/25, 1/16/25, 1/25/25, 2/1/25, and 2/8/25 were not completed until 3/25.25. During interview with the Administrator (ADM) and the Clinical Manager (CM) on 3/28/25 at 2:30 p.m., query was made to whether the SN visits were actually made. CM stated yes, they were all made and stated that she took notes each visit but had not put them in the medical record due to her busy schedule. ADM and CM acknowledged that the clinical notes had not been prepared for this patient.

Ensure clinical manager is available CFR(s): 484.105(b)(1)(iii) (iii) Ensure that a clinical manager as described in paragraph (c) of this section is available during all operating hours; This ELEMENT is not met as evidenced by: Based on observation and interview, the agency failed to ensure the clinical manager was available during all operating hours potentially resulting in lack of prompt care coordination for the 3 active patients at the time of survey. Findings include: On 3/25/25 at 11:34 a.m., entrance for the survey was attempted at the address listed for the agency. Upon arrival to the approved address, it was noted that signage validated that the agency resided at the address and the front door to the agency was locked. A handwritten sign was on the front door which read “3/24/25 office CLOSED today Intake called in sick pls [please] call [name] for questions”. It was noted that the sign was dated for the day prior to day of attempted entrance. A cell phone number and name (no identifier) was listed to call for questions. At 11:38 a.m., call was initiated to the cell phone number as identified on the sign of the agency door. A voice mail message answered the call and stated that the number belonged to an agency nurse (identified by name), and to leave a message. A general message was in turn left at the number from the door sign which included (surveyor) name, date, time, and location (onsite at agency), phone number, and message to please call back as soon as possible. Call was also initiated to the home health agency main number which was listed with the State Agency at 11:40 a.m., and it was noted the number was disconnected. No call was received back as a result of the message left at 11:38 a.m., so another call was attempted to the number left on the door sign of the agency at 12:40 p.m. (58 minutes later). Message left by surveyor this time included that the State Agency was onsite at the agency location and required call back. At 12: 45 p.m. (5 minutes later) the nurse from the phone number who identified herself on the phone as the Clinical Manager (CM) called back and reported that she was “at work” at a local hospital and she would need to get approval from her work manager to leave her post and come to the agency to assist surveyors, but that it would not be before 3:30 p.m. CM stated that the Administrator (ADM) was driving in another state and was unavailable. CM stated that the home care agency had 3 active patients and that the main phone number for the agency had been changed via Form CMS-855A and gave the new main agency phone number to the surveyor. CM called surveyor back at 3:20 p.m. and stated that she was “on her way”. The CM did not arrive to the agency location until 4:40 p.m. (5 hours and 6 minutes after requested entry). The agency Clinical Manager (CM) was not available during all operating hours. This finding was reviewed and acknowledged during interview on 3/25/25 at 4:50 p.m. with the Clinical Manager (CM).

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 record review and interview, the agency failed to ensure the clinical record was accurate and contained all interventions, treatments, services, and responses to treatment in 3 (P-2, 3, and 6) of 7 records reviewed (see G1014); failed to ensure a completed discharge summary was sent to the primary care practitioner or other health care professional responsible for providing care and services to the patient after discharge in 4 (P-2, 3, 4, and 5) of 4 discharged records reviewed (see G1022); and failed to ensure all entries were clear, complete, appropriately authenticated, dated and timed in accordance with agency policy in 6 (P-1, 2, 3, 4, 6, and 7) of 7 sampled records reviewed (see G1024); resulting in unclear, incomplete, and unauthenticated records and the potential for unmet care needs. Findings include: The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care in a safe environment for the condition of participation of 42 CFR §484.110 Clinical Records.

Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record was accurate and contained all interventions, treatments, services, and responses to treatment in 3 (P-2, 3, and 6) of 7 records reviewed, resulting in an incomplete medical record. Findings include: **Policy titled “Client Care Records” (reviewed 8/2007) stated, “It is crucial that accurate and complete client care records be maintained to meet the legal purpose of documentation and that records be kept in a safe, secure location.” P-2: This 78-year-old patient was admitted to this home care agency on 11/18/24 with the diagnoses of idiopathic gout, type II diabetes, and chronic kidney disease. During review of the occupational therapy evaluation on 3/26/25, it was noted the section for strength and range of motion (ROM) listed that the shoulder, hand, and digits were tested. However, the documentation failed to provide details of what specific directions were tested. Therefore, the record is incomplete. Upon further review of the occupational therapy evaluation, it was noted under “Assessment” that, “…”good demonstration of all written HEP (home exercise program) provided to pt (patient) in folder.” This statement was also included on daily occupational therapy notes dated 12/6/24, 12/13/24, 12/19/24, 12/26/24, 1/2/25. There was also no documentation regarding which exercises were provided for the HEP. Additionally, it was noted during review of the occupational therapy daily notes that the following statement was noted under the “Assessment” section on 12/19/24, 12/26/24, and 1/2/25: “Pt alert and cooperative throughout OT intervention with good demonstration of all written HEP provided to pt in folder with c/o difficulty sleeping the past 2 nights .Ot educating -pt in sleep techniques with darkness; no caffeine 4 hrs prior to sleep; colder temp in room; relaxing music app in cell phone and use of head phone if needed to reduce outside noise/distractions to good understanding by pt” [sic] This statement was copied word-for-word, therefore, is not an accurate or up to date representation of the patient’s response to treatment. P-3: This 90-year-old patient was admitted to this home health agency on 11/9/24 with the diagnoses of acute bronchitis, chronic obstructive pulmonary disease (COPD), and a stage 2 pressure ulcer of her left buttock. During record review on 3/27/25, it was noted the patient was given an HEP by the physical therapist on 11/15/24. There was no documentation regarding which exercises were provided for the HEP. Upon further review of the record, it was noted 9 of 9 daily physical therapy notes dated between 11/19/24 and 12/17/24 failed to include details on what exercises were performed during treatment as well as details regarding frequency, amount, and assist needed. Therefore, the record is incomplete. Findings were reviewed with and acknowledged by the Administrator (ADM) and Clinical Manager (CM) during an interview on 3/28/25 at 3:30 PM. P-6: This 93-year-old was admitted to the agency on 2/17/25 with diagnoses including pressure ulcers of the sacral region, back, and left heel. The medical record was reviewed on 3/27/25. During review, it was noted that 4 nursing notes (dated 2/24/25; 3/3/25; 3/11/25; 3/18/25) included a section called “Interventions/Instructions” and under the section the following were check-marked by the nurse “Teach” and “Diabetic observation”. During interview with the Administrator (ADM) and the Clinical Manager (CM) on 3/28/25 at 2:30 p.m., query was made to what it meant if the check box was marked for “Teach” and “Diabetic observation”. CM stated that this would be the intervention of education, and the associated Diabetic monitoring provided to a person with a diagnosis of Diabetes. CM acknowledged that P-6 did not have a diagnosis of Diabetes and acknowledged that the medical record did not accurately reflect interventions which were provided to P-6.

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 record review and interview, the agency failed to ensure a completed discharge summary was sent to the primary care practitioner or other health care professional responsible for providing care and services to the patient after discharge in 4 (P-2, 3, 4, and 5) of 4 discharged records reviewed, resulting in the potential for unmet care needs. Findings include: P-2: This 78-year-old patient was admitted to this home care agency on 11/18/24 with the diagnoses of idiopathic gout, type II diabetes, and chronic kidney disease. During record review on 3/26/25, it was noted the patient’s last visit with the agency was on 1/6/25 with the occupational therapist. Upon further review of the record, it was noted there was no note documented by the occupational therapist on that day. Additionally, it was noted the discharge Outcomes and Assessment Information Set (OASIS) was not completed by the occupational therapist until 2/20/25 – 25 days after the patient was discharged from the agency. Therefore, a discharge summary could not have been sent to the doctor within 5 days per the regulation. P-3: This 90-year-old patient was admitted to this home health agency on 11/9/24 with the diagnoses of acute bronchitis, chronic obstructive pulmonary disease (COPD), and a stage 2 pressure ulcer of her left buttock. During record review on 3/27/25, it was noted the patient’s last visit with the physical therapist was 12/19/24 and the discharge summary was completed on 12/22/24. According to the discharge OASIS dated 12/22/24, the physician was notified. During an interview with the Administrator (ADM) and Clinical Manager (CM) on 3/28/25 at 3:30 PM, CM was asked for evidence the discharge summary was sent to the physician. CM stated she usually prints the discharge summary and stamps it as “faxed” upon completion. CM was unable to locate this in the record and stated that meant it had not been done. CM and ADM acknowledged the findings at the time of interview. P-4: This 86-year-old was admitted to the agency on 12/24/24 with diagnoses including gastrointestinal bleed; atrial fibrillation (a heart arrythmia); and high blood pressure. The medical record was reviewed on 3/28/25. During review, it was noted that the patient was transferred to an inpatient facility on 2/8/25. The registered nurse completed the transfer/discharge summary on 2/8/25 and documented that the medical record information including plan of care and medication list was faxed but did not include the date, name, or number of the person or facility the fax was going to. During interview with the Administrator (ADM) and the Clinical Manager (CM) on 3/28/25 at 2:30 p.m., query was made to whether the transfer/discharge summary was sent to the receiving facility and/or physician and when. ADM replied that they (the agency) attach a copy of the faxed document with the stamped date for which it was faxed in the patients paper record. ADM stated that if it is not in the paper record, it was probably not done. No further documentation of either a transfer summary to a receiving facility or a discharge summary to a physician could be located at the time of the interview. Both ADM and CM acknowledged the finding. P-5: This 82-year-old was admitted to the agency on 7/13/24 with diagnoses including type 2 Diabetes; high blood pressure; and unsteadiness while on feet. The medical record was reviewed on 3/28/24. During review, it was noted that the physical therapist completed a discharge summary on 9/1/24. The discharge summary included documentation that the physician was made aware of the discharge. There was no evidence that a discharge summary had been sent to the physician in either the electronic or paper medical record. This finding was reviewed during interview on 3/28/25 at 2:30 p.m. by ADM and CM. No additional evidence was provided at the time of interview and the finding was acknowledged by both ADM and CM.

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 record review and interview, the agency failed to ensure all entries were clear, complete, appropriately authenticated, dated and timed in accordance with agency policy in 6 (P-1, 2, 3, 4, 6, and 7) of 7 sampled records reviewed resulting in unclear, incomplete, and unauthenticated records. Findings include: **Policy titled “Client Care Records” (reviewed 8/2007) stated, “It is crucial that accurate and complete client care records be maintained to meet the legal purpose of documentation and that records be kept in a safe, secure location.” It also stated, “...k) Clinical assessment, visit and coordination notes signed and dated by each discipline…”. P-1: This 85-year-old patient was admitted this home health agency on 3/20/25 with the diagnoses of chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), and type II diabetes. During record review on 3/26/25, the following statement was found on the Outcome and Assessment Information Set (OASIS): “Son id only giving her 12 un of Insulin instead of 20. Blood sugars drops to 50 is she gives Office of Dr. Aquino notified.” [sic] This statement contains errors and is unclear. P-2: This 78-year-old patient was admitted to this home care agency on 11/18/24 with the diagnoses of idiopathic gout, type II diabetes, and chronic kidney disease. During record review on 3/26/25, it was noted the occupational therapy evaluation contained the abbreviation “TPW” in the goals section. Upon review of a document with agency-approved abbreviations (filed under “General Patient Record Policies”), it was determined “TPW” was not approved for use by the agency. Upon further review of the record, it was determined the OASIS/skilled nursing initial evaluation and daily skilled nursing note dated 11/27/24 were not signed or dated by the registered nurse. Additionally, occupational therapy notes dated 12/26/24 and 1/2/25 were not signed or dated by the occupational therapist. Therefore, the record was not properly authenticated. P-3: This 90-year-old patient was admitted to this home health agency on 11/9/24 with the diagnoses of acute bronchitis, chronic obstructive pulmonary disease (COPD), and a stage 2 pressure ulcer of her left buttock. During record review on 3/27/25, it was noted the physical therapy evaluation contained the following abbreviations: “CTLS”, “AP”, “LOM”, and “ms”. Upon review of a document with agency-approved abbreviations (filed under “General Patient Record Policies”), it was determined these were not approved for use by the agency. Upon further review of the record, it was determined the skilled nursing notes dated 11/12/24, 11/20/24/ 11/26/24, and 12/3/24 were not signed or dated by the registered nurse who completed them. Therefore, the record was not properly authenticated. Findings were reviewed with and acknowledged by the Administrator (ADM) and Clinical Manager (CM) during an interview on 3/28/25 at 3:30 PM. P-4: This 86-year-old was admitted to the agency on 12/24/24 with diagnoses including gastrointestinal bleed; atrial fibrillation (a heart arrythmia); and high blood pressure. The medical record was reviewed on 3/28/25. During review of the discharge summary entered by the skilled nurse (SN) on 2/8/25, it was noted that there was no authentication signature, title, or date by the SN who completed the discharge summary. P-6: This 93-year-old was admitted to the agency on 2/17/25 with diagnoses including pressure ulcers of the sacral region, back, and left heel. The medical record was reviewed on 3/27/25. During review, it was noted that the SN entered a visit on 3/11/25 and did not authenticate the note with a signature, title, or date. Additionally, the SN entered visit notes on 2/24/25, 3/3/25, and 3/18/25 which were all left undated by the SN. P-7: This 94-year-old was admitted to the agency on 3/10/25 with diagnoses including pressure ulcer of right buttock; hypertensive heart disease (heart problems due to high blood pressure); and kidney disease. The medical record was reviewed on 3/26/25. During review, it was noted that the SN entered a visit on 3/19/25 and did not authenticate the note with a signature, title, or date. Additionally, the SN entered visit notes on 3/13/25 and 3/23/25 which were left undated by the SN. These findings were reviewed and acknowledged during interview on 3/28/25 at 2:30 p.m. by the agency Administrator (ADM) and the Clinical Manager (CM).

The following Condition level citations were identified during an Emergency Preparedness Survey conducted by the Michigan Department of Licensing and Regulatory Affairs on 4/4/22 through 4/7/22 at: AIMM Home Health Services 4086 Rochester Rd., Suite 204 Troy, MI 48085 At the time of the survey, AIMM Home Health Services, was found to be non-compliant with the requirements for the Condition of Participation at: 42 CFR §484.102, Emergency Preparedness

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, §485.625, §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 record review and interview, the Agency failed to ensure an emergency plan existed that was based on a documented facility and community-based risk assessment from an all-hazards approach, including strategies to address the identified risks and the Covid-19 global pandemic, resulting in the potential for lack of preparedness and poor patient and staff outcomes, in the event of an actual emergency (E0006); failed to develop an individualized emergency plan that identified the specific needs of the patient and identified the patient's priority level in the event of an emergency, as well as provide a copy to the patient and or their caregiver for 1 (MR #5) of 1 patient observed during a home visit, from a total of 7 sampled records reviewed, resulting in the potential for interruption in care and services and unmet care needs (E0017); failed to develop and maintain an emergency preparedness communication plan that included contact information for all current staff, patients, patient's physicians, and volunteers, as appropriate, which had the potential to negatively affect the health and safety of the 7 patients currently serviced by this agency, resulting in the lack of effective communication in the event of an actual emergency (E0030); failed to provide initial and ongoing training in Emergency Preparedness policies and procedures to all new and existing staff, including contract employees and volunteers, as appropriate, and failed to maintain documentation of training's, resulting in the potential for inappropriate, unprepared responses to emergencies and interruption in the provision of needed patient care and services (E0037). The cumulative effect of these systemic problems could potentially have a negative effect on all patients cared for by the home health agency in the event staff is not properly prepared for an emergency for the Condition of Participation of 42 CFR §485.102, Emergency Preparedness.

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), §485.625(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 record review and interview, the Agency failed to ensure an emergency plan existed that was based on a documented facility and community-based risk assessment from an all-hazards approach, including strategies to address the identified risks and the Covid-19 global pandemic, resulting in the potential for lack of preparedness and poor patient and staff outcomes, in the event of an actual emergency. Findings include: On 4/7/22 at 9:10 a.m., the agency's Emergency Preparedness Plan was reviewed. During the review, with the Clinical Manager (CM #1) it was noted that the plan had not been updated to include strategies for addressing the risks identified in the Risk Assessment. Further, the plan failed to include any strategies to address the Covid-19 global pandemic. These findings were reviewed with and confirmed by CM #1 at the time of discovery.

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 observation, interview and record review, it was determined that the Agency failed to develop an individualized emergency plan that identified the specific needs of the patient and identified the patient's priority level in the event of an emergency, as well as provide a copy to the patient and or their caregiver for 1 (MR #5) of 1 patient observed during a home visit, from a total of 7 sampled records reviewed, resulting in the potential for interruption in care and services and unmet care needs. Findings include: MR #5: The patient's start of care (SOC) was 2/21/22 with diagnoses that included Paraplegia and Atherosclerotic Heart Disease. On 4/4/22 at 12:30 p.m., during a scheduled home visit with the Physical Therapist/Administrator (Adm #1/PT #1) it was noted that the patient's individualized Emergency Preparedness Plan was left blank. Upon completion of the visit, Adm #1/PT #1 was queried about the blank document and reported, "I just forgot to complete it." These findings were reviewed with and acknowledged by Adm #1 at the time of discovery at the onsite visit.

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), §485.625(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 record review and interview, it was determined that the facility failed to develop and maintain an emergency preparedness communication plan that included contact information for all current staff, patients, patient's physicians, and volunteers, as appropriate, which had the potential to negatively affect the health and safety of the 7 patients currently serviced by this agency, resulting in the lack of effective communication in the event of an actual emergency. Findings include: During a review of the agency's emergency preparedness documents on 4/7/22 at 9:10 a.m., with the Clinical Manager (CM #1), it was noted that there was no contact information for all current staff, patient's physicians, or volunteers as appropriate. These findings were reviewed with CM #1 at the time of discovery.

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), §485.625(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, "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 record review and interview, it was determined the Agency failed to provide initial and ongoing training in Emergency Preparedness policies and procedures to all new and existing staff, including contract employees and volunteers, as appropriate, and failed to maintain documentation of training's, resulting in the potential for inappropriate, unprepared responses to emergencies and interruption in the provision of needed patient care and services. Findings include: On 4/7/22 at 9:10a.m., the Agency's Clinical Manager (CM #1) was asked to provide documented evidence that all staff, including contracted staff, had received initial and ongoing training in Emergency Preparedness policies and procedures, yet was unable to do so. When asked if the agency had in fact provided Emergency Preparedness training to staff, including contracted staff, CM #1 responded, "No." The Agency failed to provide initial and ongoing training in Emergency Preparedness policies and procedures to all new and existing staff, including contract employees and volunteers, as appropriate, and failed to maintain documentation of trainings. These findings were reviewed with and acknowledged by CM #1 at the time of discovery.

A Medicare Recertification survey was conducted from 4/4/22 to 4/7/22, by the Michigan Department of Licensing and Regulatory Affairs at: AIMM Home Health Care 4086 Rochester Rd. suite 204 Troy, MI 48085 At the time of this survey the agency operated no extension sites. This survey included a review of all employee vaccinations. For this survey, 7 records were reviewed as follows; 2 discharge, 2 home visits, and 3 active records with no home visits. And the conclusion of this survey it was determined the agency was out of compliance at the condition level, for the conditions of participation at: 42 CFR §484.55: Comprehensive Assessment of Patients 42 CFR §485.102: Emergency Preparedness. 42 CFR §484.65: Quality assessment and performance improvement (QAPI). 42 CFR §484.70: Infection prevention and control. As a result of the Condition level noncompliance, the Agency is prohibited for 2 years (from the date of the initial survey conducted on 4/7/22) from offering a Home Health Aide training and competency evaluation or a competency evaluation program as specified in 42 CFR §484.80(f)(3).

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the agency failed to ensure that 2 (MR #3 and 5) patients observed during a home visit, from a total of 3 home visits, was included in the overall planning of care, including informing the patient/caregiver in advance of the days in which services would be provided and disciplines that will furnish care, resulting in a lack of inclusion in planning, lack of informed consent, the potential for missed visits and unmet care needs. Findings include: Policy: "Plan of Care/485" Policy #: C-480, 11/2020 stated, "The patient/representative, therapist, and other Agency personnel shall participate in developing the Plan of Care." MR #5: The patient's start of care (SOC) was 2/21/22 with diagnoses that included Paraplegia and atherosclerotic heart disease. On 4/4/22 at 12:30 p.m., a scheduled home visit was conducted with the Physical Therapist/Administrator (Adm #1). During the visit, it was noted that the patient's admission packet was void of a calendar of proposed visits to be made by the Physical Therapist (Adm #1). Upon completion of the visit, the patient inquired, "So when are you coming back?" to which Adm #1 reported, "Sometime next week. I'll call first." The Agency failed to ensure a calendar of proposed visits had been provided at the SOC to assist the patient with participating in planning in his care and daily routine. These findings were reviewed with and acknowledged by Adm #1 and the Clinical Manager (CM #1 during an interview on 4/6/22 at 1:05 p.m. MR #3: The patient's start of care (SOC) was 3/29/22, with diagnoses that included polyosteoarthritis, cerebral infarct, polyneuropathy and hypertension. On 4/6/22, a scheduled home visit was conducted with the Physical Therapist/Administrator (Adm#1). During the visit, it was discovered that the patient's admission packet had no documented calendar of proposed visits to be made by Adm#1. During an interview on 4/7/22 at 9:00 a.m., the administrator (Adm#1) and the clinical manager (CM#1) acknowledged the above findings.

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 record review and interview, the Agency failed to ensure the patient received proper written notice (Notice of Medicare Provider Non-Coverage) in advance of the agency terminating on-going care for 1 (MR #6) of 2 discharged records, resulting in the patient being denied the right to appeal the decision to end covered services. Findings include: MR #6: The patient's start of care (SOC) was 5/24/21 with diagnoses that included Acute on Chronic Congestive Heart Failure, Hypertension and Osteoarthritis. The record review, conducted on 4/4/22 at 3:12 p.m., revealed the following: The plan of care (POC) ordered Skilled Nursing (SN) and Physical Therapy (PT) services to be provided. The patient discharged from the agency's services on 7/21/21. There was no documented evidence that the patient was provided the "Notice of Medicare Provider Non-Coverage" prior to being discharged from the agency. The Agency failed to ensure the patient received proper written Notice of Medicare Provider Non-Coverage in advance of the agency terminating on-going care. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and the clinical Manager (CM #1) during an interview on 4/6/22 at 1:53 p.m.

Document complaint and resolution CFR(s): 484.50(e)(1)(ii) (ii) Document both the existence of the complaint and the resolution of the complaint; and This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to document the existence of complaints received, details of the the investigation and the resolution of the complaints, as per this requirement, resulting in the potential for unaddressed patient/family concerns, inability to exercise one's rights and unmet care needs. Findings include: Policy: "Complaint or Grievance Procedure" C-18 stated, "The supervisor will investigate the problem with you and the involved staff..., The supervisor will inform you within 5 working days of the outcome of the investigation..., The investigation and resolution of your complaint will be brought to the attention of the agency's Performance Improvement program and governing Body." On 4/6/22 at 9:20 a.m., the Clinical Manager (CM #1) was asked for permission to review the agency's complaint log. Shortly after, CM #1 presented with a policy titled, "Complaint or Grievance Procedure" and stated, I don't have any documentation of the complaints. I just take care of the matter. The Administrator (Adm #1) and I just handle the matter. I can start documenting. Because we only have 7 to 10 patients sometimes, I just don't document but if it's like a sentinel event, I would document." The Agency failed to ensure that all complaints, investigative measures and the resolutions, as appropriate, were documented as per this requirement. These findings were reviewed with and acknowledged by CM #1 at the time of discovery.

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 record review and interview, the Agency failed to ensure the Registered Nurse conducted the Initial Comprehensive Assessment within 48 hours of the date of referral for 2 (MR's #5, 6) of 3 records reviewed where start of care services was delayed, from a total of 7 sampled records reviewed, resulting in delay in needed care and services and the potential for declining health status and unmet care needs (G514); failed to ensure the Physical Therapist conducted the Initial Comprehensive Assessment within 48 hours of the date of the referral for 1 (MR #7) of 1 record reviewed where Physical Therapy was ordered to begin care, from a total of 7 sampled records reviewed, resulting in the potential for decline in physical functioning and unmet care needs (G516); failed to ensure the Comprehensive Assessment accurately reflected the patient's current health status at the time of admission for 7 (MR's #1, 2, 3, 4, 5, 6, 7) records reviewed, resulting in incomplete clinical information to aide in determining the required treatments and needs of the patients and for measuring the patient's progress toward goals/outcomes (G528); failed to ensure the patient's Activities of Daily Living needs were adequately met in the patient's home in 3 (MR's #5, 6, 7) of 3 records reviewed of patients who required assistance with grooming, from a total of 7 sampled records reviewed, resulting in the potential for lack of needed grooming, loss of self-esteem and unmet care needs (G534); failed to ensure the comprehensive assessment included a review of all medications to determine any adverse effects; and, failed to document the findings of the drug regime review as required and failed to ensure the Physician was notified of potential drug interactions in 3 (MR's #5, 6, 7) of 7 sampled records reviewed, resulting in the potential for harmful medication effects for all 7 patients currently serviced by this Agency (G536). The cumulative effect of these systemic problems resulted in the Agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR§484.55 Comprehensive Assessment of 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 record review and interview, the Agency failed to ensure the Registered Nurse conducted the Initial Comprehensive Assessment within 48 hours of the date of referral for 2 (MR's #5, 6) of 3 records reviewed where start of care services was delayed, from a total of 7 sampled records reviewed, resulting in delay in needed care and services and the potential for declining health status and unmet care needs. Findings include: Policy: "Patient Comprehensive Assessment" 4/2017, C-150 stated, "When the RN is the Case Manager, the RN must make the first visit within 48 hours of referral unless otherwise specified by the physician..., Any discipline that does not make the initial visit within the specified time frame must make a notation in the patient’s medical record that indicates why there was a delay in start of care. The referring physician must be notified as soon as possible of both the delay and the reason." MR #5: The patient's start of care (SOC) was 2/21/22 with diagnoses that included Paraplegia and Atherosclerotic Heart Disease. During the record review on 4/4/22 at 11:15 a.m., it was noted that the Referral for home care dated 2/16/22 ordered Skilled Nursing (SN) and Physical Therapy (PT) services to be provided. The SN did not conduct the Initial Comprehensive Assessment until 2/21/22. This was 5 days after the date of the referral. There was no documented rationale for the delay in services and no evidence that the patient declined services. Additionally, there was no documented evidence that the Physician was made aware in the delay in the provision of services. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and the Clinical Manager (CM #1) during an interview on 4/6/22 at 1:05 p.m. MR #6: The patient's SOC was 5/24/21 with diagnoses that included Congestive Heart Failure (CHF), Hypertension and Osteoarthritis. During the record review on 4/4/22 at 3:12 p.m., it was noted that the Referral for home care dated 5/21/21 SN and PT services to be provided. The SN did not conduct the Initial Comprehensive Assessment until 5/24/21. This was 3 days after the date of the referral. There was no documented rationale for the delay in services and no evidence that the patient declined services. Additionally, there was no documented evidence that the Physician was made aware in the delay in the provision of services. These findings were reviewed with and acknowledged by Adm #1 and CM #1 during an interview on 4/6/22 at 1:53 p.m. The Agency failed to ensure the SN conducted the Initial Comprehensive Assessment within 48 hours of the date of the referral for home care.

Skilled professional performs assessment CFR(s): 484.55(a)(2) When rehabilitation therapy service (speech language pathology, physical therapy, or occupational therapy) is the only service ordered by the physician who is responsible for the home health plan of care, and if the need for that service establishes program eligibility, the initial assessment visit may be made by the appropriate rehabilitation skilled professional. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined that the Agency failed to ensure the Physical Therapist conducted the Initial Comprehensive Assessment within 48 hours of the date of the referral for 1 (MR #7) of 1 record reviewed where Physical Therapy was ordered to begin care, from a total of 7 sampled records reviewed, resulting in the potential for decline in physical functioning and unmet care needs. Findings include: Policy: "Patient Comprehensive Assessment" 4/2017, C-150 stated, "If Physical or Speech Therapy is the Case Manager, they must make their initial visit within 48 hours of the referral unless otherwise specified by the physician or per family request...,Any discipline that does not make the initial visit within the specified time frame must make a notation in the patient’s medical record that indicates why there was a delay in start of care. The referring physician must be notified as soon as possible of both the delay and the reason." MR #7: The patient's start of care (SOC) was 3/16/22 with diagnoses that included Hereditary/Idiopathic Neuropathy, Hypertension and Muscle Weakness. During the record review on 4/5/22 at 2:33 p.m., it was noted that the referral for home care was dated 3/10/22 and ordered Physical Therapy (PT) services to be provided. Further review revealed the PT did not conduct the Initial Comprehensive Assessment until 3/16/22. This was 6 days after the date of the referral. The Agency failed to ensure the Physical Therapist conducted the Initial Comprehensive Assessment within 48 hours of the date of the referral. These findings were reviewed with the Administrator (Adm #1) and the Clinical Manager (CM #1) during an interview on 4/6/22 at 2:10 p.m.

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 record review and interview, the agency failed to ensure the Comprehensive Assessment accurately reflected the patient's current health status at the time of admission for 7 (MR's #1, 2, 3, 4, 5, 6, 7) records reviewed, resulting in incomplete clinical information to aide in determining the required treatments and needs of the patients and for measuring the patient's progress toward goals/outcomes. Findings include: MR #5: The patient's start of care (SOC) was 2/21/22 with diagnoses that included Paraplegia, Atherosclerotic Heart Disease and Peripheral Vascular Disease. The clinical record review was conducted on 4/4/22 at 11:15 a.m. The Initial Comprehensive Assessment (ICA) dated 2/21/22 completed by the Registered Nurse (RN) revealed the following: Section 1021 "Primary Diagnosis" listed a primary diagnosis of Paraplegia. Section 1023 "Other diagnoses" listed Peripheral Vascular Disease, Osteoarthritis of hip and knee and Hypertension. All the listed diagnoses had dates of 2/16/22. It could not be determined if the diagnoses were of new onset or exacerbation (O/E). There was no history of the status of the above diagnoses or diseases including treatments for past medical history problems and outcomes from the treatments. The ICA documented that materials were provide for disease "Dementia", however, this was not one of the listed diagnoses. The sections titled, "Educational Level" and "Spiritual" were left blank. The Comprehensive Assessment failed to accurately reflect the patient's health status at the time of admission. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Clinical Manager (CM #1) during an interview on 4/6/22 at 1:05 p.m. MR #6: The patient's SOC was 5/24/21 with diagnoses that included Acute on Chronic Congestive Heart Failure (CHF), Hypertension and Diabetes Mellitus. The clinical record review was conducted on 4/6/22 at 1:53 p.m. The ICA dated 5/24/21, completed by the RN revealed the following: Section 1021 listed a primary diagnosis of Acute on Chronic Congestive Heart Failure. Section 1023 listed Hypertension, Osteoarthritis, Diabetes Mellitus, Unsteadiness on Feet, Asthma, Vitamin D Deficiency and Urinary Incontinence. All the listed diagnoses had dates of 5/24/21. It could not be determined if the diagnoses were of new onset or exacerbation (O/E). There was no history of the status of the above diagnoses or diseases including treatments for past medical history problems and outcomes from the treatments. The patient's weight was recorded as 179, however, there was no indication if this was an actual or reported weight. The section titled "Living Arrangements/Supportive Assistance, Primary Caregiver" was left blank. The section that addressed "Pain" level was left blank. The "Endocrine" section documented the patient's blood sugar as "100's" The RN failed to document an accurate baseline blood sugar. The sections titled, "Educational Level" and "Spiritual" were left blank. The Comprehensive Assessment failed to accurately reflect the patient's health status at the time of admission. These findings were reviewed with and acknowledged by Adm #1 and CM #1 during an interview on 4/6/22 at 1:53 p.m. MR #7: The patient's SOC was 3/16/22 with diagnoses that included Hereditary/Idiopathic Neuropathy and Hypertension. During the record review on 4/5/22 at 2:33 p.m., it was noted that the ICA dated 3/16/22 completed by the Physical Therapist listed Hereditary/Idiopathic Neuropathy as the primary diagnosis. Hypertension, Muscle weakness, Pain bilateral knees and Difficulty Walking were all listed under section M1023. All the above listed diagnoses had a date of 3/10/22. There was no history of the status of the above diagnoses or diseases including treatments for past medical history problems and outcomes from the treatments. The Comprehensive Assessment failed to accurately reflect the patient's health status at the time of admission. These findings were reviewed with and acknowledged by Adm #1 and CM #1 during an interview on 4/6/22 at 2:10 p.m. MR #1: The patient's SOC was 2/25/22, with diagnoses that included spinal stenosis, hypertension and atrial fibrillation. The clinical record review was conducted on 4/4/22. The initial comprehensive assessment (ICA) dated 2/25/22, completed by the RN revealed the following: Section 1021 listed spinal stenosis as the primary diagnosis with a date of 2/25/22. Section 1023 listed hypertension, atrial fibrillation, abnormality of gait, Alzheimer's and dementia all having a date of 1/13/22. It could not be determined if the diagnoses were of new onset or exacerbation (O/E). There was no history of the status of the above diagnoses or diseases including treatments for past medical history problems and outcomes from the treatments. The subsections for each body system did not document any further details regarding each diagnosis. The section that addressed "Pain" level was left blank. MR #2: The patient's SOC was 3/27/22, with diagnoses that included type 2 diabetes mellitus, falls, ataxia and end stage renal disease. The clinical record review was conducted on 4/5/22. The ICA dated 3/27/22, completed by the RN revealed the following: Section 1021 listed type 2 diabetes mellitus as the primary diagnosis with a date of 3/26/22. Section 1023 listed type 2 diabetes mellitus with diabetic peripheral angiopathy, type 2 diabetes mellitus with diabetic chronic kidney disease, falls, ataxia and end stage renal disease all having the same date of 3/27/22. It could not be determined if the diagnoses were of new onset or exacerbation (O/E). There was no history of the status of the above diagnoses or diseases including treatments for past medical history problems and outcomes from the treatments. The subsections for each body system did not document any further details regarding each diagnosis. MR #3: The patient's SOC was 3/29/22, with diagnoses that included polyosteoarthritis, cerebral infarct, polyneuropathy and hypertension. The clinical record review was conducted on 4/6/22. The ICA dated 3/29/22, completed by the RN revealed the following: Section 1021 listed polyosteoarthritis as the primary diagnosis with a date of 3/22/22. Section 1023 listed cerebral infarct, polyneuropathy and malignant neoplasm of prostate, all having the same date of 3/22/22. Hypertension and chronic kidney disease diagnoses had dates of 3/29/22. It could not be determined if the diagnoses were of new onset or exacerbation (O/E). There was no history of the status of the above diagnoses or diseases including treatments for past medical history problems and outcomes from the treatments. The subsections for each body system did not document any further details regarding each diagnosis. MR #4: The patient's SOC was 9/1/21, with diagnoses that included peripheral vascular disease, dementia, difficulty walking, weakness and osteoarthritis of hip. The clinical record review was conducted on 4/6/22. The ICA dated 9/1/21, completed by the RN revealed the following: Section 1021 and 1023 listed the above diagnoses with the same date of 9/1/21. It could not be determined if the diagnoses were of new onset or exacerbation (O/E). There was no history of the status of the above diagnoses or diseases including treatments for past medical history problems and outcomes from the treatments. The subsections for each body system did not document any further details regarding each diagnosis. During an interview on 4/7/22 at 9:00 a.m., the administrator (Adm#1) and the clinical manager (CM#1) acknowledged the above findings.

Patient's needs CFR(s): 484.55(c)(4) The patient's medical, nursing, rehabilitative, social, and discharge planning needs; This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the patient's Activities of Daily Living needs were adequately met in the patient's home in 3 (MR's #5, 6, 7) of 3 records reviewed of patients who required assistance with grooming, from a total of 7 sampled records reviewed, resulting in the potential for lack of needed grooming, loss of self-esteem and unmet care needs. Findings include: Policy: "Admission to Home Health Care" C-140, 11/2020 stated, "Patients are accepted for treatment in the home based on reasonable criteria and under the expectation that their medical, nursing, therapy and social needs can be adequately met by the Agency in their place of residence." MR #5: The patient's start of care (SOC) was 2/21/22 with diagnoses that included Paraplegia, Atherosclerotic Heart Disease and Peripheral Vascular Disease. During the clinical record review on 4/4/22 at 11:15 a.m., the Plan of Care (POC) revealed the following: "Functional Limitations: Bowel/Bladder incontinence, Hearing, Endurance, Wheelchair, Prognosis: Fair, Safety Measures: Fall risk: High, Hoyer lift (transfer aid), Requires considerable assistance in routing situations." The Initial Comprehensive Assessment dated 2/21/22 revealed the patient had contractures and decreased range of motion (ROM) bilateral lower extremities. Section M1800 documented, "Patient depends entirely upon someone else for grooming needs..., Totally dependent in toileting." Further review revealed that no Home Health assistance had been provided. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and the Clinical Manager (CM #1) during an interview on 4/6/22 at 1:05 p.m. When asked if the patient or caregiver had been offered the services of a Home Health Aide, CM #1 reported, "No." The Agency failed to ensure the patient's Activities of Daily Living (ADL) needs were adequately met. MR #6: The patient's SOC was 5/24/21 with diagnoses that included Acute on Chronic Congestive Heart Failure (CHF) and Hypertension. During the record review on 4/4/22 at 3:12 p.m., it was noted that section M1800 of the Initial Comprehensive Assessment indicated the patient required assistance with grooming, dressing and toileting. The section of the assessment titled "Living Arrangements/Supportive Assistance" was left blank. There was no indication if the patient had any assistance with the provision of ADL services. Upon further review, it was noted that Home Health services had not been provided. These findings were reviewed with and acknowledged by Adm #1 and CM #1 during an interview on 4/6/22 at 1:53 p.m. When asked if the patient had been offered the services of a Home Health Aide, CM #1 reported, "No." The Agency failed to ensure the patient's Activities of Daily Living (ADL) needs were adequately met. MR #7: The patient's SOC was 3/16/22 with diagnoses that included Hereditary/Idiopathic Neuropathy, Hypertension and Muscle Weakness. The record review was conduced on 4/5/22 at 2:33 p.m. and revealed: the POC listed, "Functional Limitations: endurance, ambulation, dyspnea (shortness of breath), Safety Measures: Fall Risk: High, Walker, Bleeding Precautions, easy fatigue, cane, Forgetful..." Section M1800 of the Initial Comprehensive Assessment dated 3/16/22 stated, "Someone must assist the patient to groom self." Further review revealed that no Home Health assistance had been provided. These findings were reviewed with and acknowledged by Adm #1 and CM #1 during an interview on 4/6/22 at 2:10 p.m. When asked if the patient or caregiver had been offered a Home Health Aide, CM #1 reported, "No." The Agency failed to ensure the patient's Activities of Daily Living (ADL) needs were adequately met.

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 record review and interview, it was determined the Agency failed to ensure the comprehensive assessment included a review of all medications to determine any adverse effects; failed to document the findings of the drug regime review as required and failed to ensure the Physician was notified of potential drug interactions in 3 (MR's #5, 6, 7) of 7 sampled records reviewed, resulting in the potential for harmful medication effects for all 7 patients currently serviced by this Agency. Findings include: Policy: "Medication Profile", C-600, 11/2020 stated, "The Drug Regimen Review shall include: Medication name, Medication dosage, Contraindications, Medication actions and side effects, Drug or food-drug interactions Duplicate drug therapy. At the time of admission to the home care agency, the admitting professional will document a complete list of medications taken by the patient prior to admission. This will include all over the counter, prescribed, and PRN medications..., The admission professional will review the medication list with the physician/allowed practitioner, and confirm those medications that are to be continued or discontinued." MR #5: The patient’s start of care (SOC) was 2/21/22 with diagnoses that included Paraplegia and Atherosclerotic Heart Disease. During the record review on 4/4/22 at 11:15 a.m. it was noted that section M2001 of the Initial Comprehensive Assessment documented “Yes-Issues found during review.” Section M2003 asked, “Did the agency contact a Physician by midnight of the next calendar day – No.” The Agency’s “Drug Interaction Report” documented 5 “Severity 3” (Highest) level drug to drug interactions. There was no documented evidence that the Agency had informed the Physician of the untoward drug interactions. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and the Clinical Manager (CM #1) during an interview on 4/6/22 at 1:05 p.m. MR #6: The patient’s SOC was5/24/21 with diagnoses that included Acute on Chronic Congestive Heart Failure, Hypertension and Osteoarthritis. During the record review on 4/4/22 at 3:12 p.m., it was noted that section M2001 documented, “Yes, issues found during the review.” Upon further review, there was no documentation of what issues had been identified. Additionally, there was no documented evidence that the Physician had been notified of the untoward interactions. These findings were reviewed with and acknowledged by CM #1 during an interview on 4/5/22 at 2:00 p.m. who stated, “There is no interaction report.” MR #7: The patient’s SOC was 3/16/22 with diagnoses that included Hereditary/Idiopathic Neuropathy, Hypertension and Muscle Weakness. During the record review on 4/5/22 at 2:33 p.m. it was noted that section M2001 of the Initial Comprehensive Assessment dated 3/16/22, completed by the Physical Therapist, documented “No issues found during review.” Section M2003 asked, “Did the agency contact a Physician by midnight of the next calendar day” was left blank. The patient’s 8 prescribed medication were entered in “Drugs.com” (online drug interaction checker) and revealed 3 moderate drug interactions and 4 duplicate drugs. There was no indication that a drug review had been conducted. Additionally, there was no evidence that the Registered Nurse provided oversight of the drug review process. These findings were reviewed with Adm #1 and CM #2 during an interview on4/6/22 at 2:10 p.m.

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 record review and interview, it was determined the agency failed to ensure the plan of care included interventions to addressed the reported diagnoses, reportable parameters and objectively measurable goals in 3 of 5 records (MR #1, 5, 6) with skilled nursing services provided, from a total of 7 sampled records reviewed, resulting in patients not receiving care specific to their individual needs, the potential for poor patient outcomes and unmet care needs. Findings include: MR #1: The start of care (SOC) was dated 2/25/22. The Plan of Care (POC) dated 2/25/22, identified the diagnoses of spinal stenosis, hypertension and atrial fibrillation. During record review on 4/4/22, it was found that the goals on the POC were not measurable, for example, one goal stated, "Stabilization of cardiovascular, pulmonary condition by 4/25/22." Another stated, "Caregiver will verbalize complications of uncontrolled hypertension, dementia and effects of immobility by 4/25/22." There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. During an interview on 4/7/22 at 9:00 a.m., the administrator (Adm#1) and the clinical manager (CM#1) acknowledged the above findings. MR #5: The patient's start of care (SOC) was 2/21/22 with diagnoses that included Paraplegia, Atherosclerotic Heart Disease and Peripheral Vascular Disease. During the record review on 4/4/22 at 11:15 a.m. it was noted that the patient was admitted with a pain level of 5/10. The Plan of Care (POC) failed to include interventions to monitor the patient's pain. The POC was vague in nature stating, "Evaluate Cardiopulmonary Status, Teach disease process." There were no interventions or measurable goals that addressed the identified diagnoses. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Clinical Manager (CM #1) during an interview on 4/6/22 at 1:05 p.m. MR #6: The patient's SOC was 5/24/21 with diagnoses that included Acute on Chronic Congestive Heart Failure (CHF) and Diabetes Mellitus. During the record review on 4/4/2 at 3:12 p.m., it was noted that the POC was void of any interventions to address the patient's diagnoses of CHF and had no reportable weight parameters in which to notify the Physician. Additionally, there was no teaching regarding CHF or Diabetes and no associated measurable goals. These findings were reviewed with and acknowledged by Adm #1 and CM #1 during an interview on 4/6/22 at 1:53 p.m.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, it was determined that the agency failed to provide 2 (MR #2, 5) of 3 patients observed during a home visit, with a Medication Profile that included the names, dosages, frequencies and side effects of the patient's prescribed medications, in plain language, from a total of 7 sampled records reviewed, resulting in lack of direction for medication administration and the potential for improper use of medications. Findings include: MR #2: The patient's start of care (SOC) was 3/27/22, with diagnoses that included diabetes, falls and ataxia. During a home visit on 4/5/22 at 11:00 a.m., it was discovered that the patient's admission packet had no documented Medication Profile to direct the patient/caregiver on the use of the prescribed medications and to ensure the patient was aware of any potential side effects or interactions. During an interview on 4/7/22 at 9:00 a.m., the administrator (Adm#1) and the clinical manager (CM#1) acknowledged the above findings. Policy: "Medication Profile" C-600, 11/2020 stated, "All medications will be listed on the Medication Profile sheet. The original will be placed in the patient's medical record, a copy placed in the patient's folder..." MR #5: The patient's start of care (SOC) was 2/21/22 with diagnoses that included Paraplegia and atherosclerotic heart disease. On 4/4/22 at 12:30 p.m., a scheduled home visit was conducted with the Physical Therapist/Administrator (Adm #1). During the visit, it was noted that the patient's admission packet was void of a Medication Schedule to direct the patient/caregiver on the use of the prescribed medications and to ensure the patient was aware of any potential side effects. the agency failed to provide the patient with a Medication Profile that included the names, dosages, frequencies and side effects of the patient's prescribed medications as per this requirement. These findings were reviewed with and acknowledged by Adm #1 and the Clinical Manager (CM #1 during an interview on 4/6/22 at 1:05 p.m.

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 record review and interview, the agency failed to develop a Quality Assessment Performance Improvement (QAPI) program to optimize patient outcomes and to have at least one performance improvement project this year. These practices could affect all of the agency's patients admitted in the past 3 years. The cumulative effect of these systemic problems resulted in the agency's inability to improve patient care, health outcomes, patient safety, and the agency's overall care performance resulting in the agency not providing quality health care. Findings include: 1. The agency failed to develop a QAPI program that was at least capable of showing measurable improvements in indicators to enhance patient outcomes, safety and quality of care in 2019, 2020 and 2021. (See G642). 2. The agency failed to collect and monitor data for the QAPI program for 2019, 2020 and 2021. (See G644). 3. The agency failed to develop and initiate any performance improvement activities as part of their QAPI program for 2019, 2020 and 2021. (See G646). 4. The agency failed to develop and initiate any performance improvement activities as part of their QAPI program that focused on high risk, high volume or problem prone areas. (See G648). 5. The agency failed to initiate any performance improvement activities within their QAPI program that considered incidence, prevalence, and severity of problems in identified areas of focus. (See G650). 6. The agency failed to develop a performance improvement project in 2019, 2020 and 2021. (See G658). 7. the agency's governing body failed to ensure there was an ongoing QAPI program that met the requirements of this section. (See G660).

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 interview and record review, it was determined that the Agency (HHA) failed to develop a Quality Assessment Performance Improvement (QAPI) program that is at least capable of showing measurable improvements in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. The Agency's program also failed to 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 resulting in the potential for the rendering of substandard care and unmet care needs for all patients served by the agency. Findings include: During record review on 4/7/22, it was discovered that the agency's Quality Assessment Performance Improvement (QAPI) program binder only had meeting minutes and attendance sheets documented. There were no quality indicators, or data documented to monitor and measure. There was no indication that the agency had developed and maintained an agency-wide program for the surveillance, investigation, identification, prevention, control and investigation of infectious and communicable diseases. During an interview on 4/7/22 at 9:00 a.m., the administrator (Adm#1) and the clinical manager (CM#1) acknowledged the above findings.

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 interview, the agency failed to collect and monitor data for the Quality Assessment and Performance Improvement (QAPI) program, to ensure the effectiveness and safety of services and quality of care to the patients and to identify opportunities for improvement, and there was no documented evidence the governing body approved the QAPI frequency and data collection process. Findings include: **Agency Policy: During review of he agency's Quality Assessment Performance Improvement (QAPI) program on 4/7/22, it was discovered that there was no documented data collected. With no data collection documented within the QAPI program, the agency was unable to monitor data, or identify opportunities for improvement. During an interview on 4/7/22 at 9:00 a.m., the administrator (Adm#1) and the clinical manager (CM#1) acknowledged the above findings.

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 interview and record review, it was determined the Agency (HHA) failed to initiate any performance improvement activities within their Quality Assessment Performance Improvement (QAPI) program, resulting in the potential for the rendering of substandard care and unmet care needs. Findings include: **Agency policy: Policy #B-200, revised 12/2017. QAPI planning function; Plan for annual QAPI evaluation, demographic data compilation, and quality improvement measures and projects. During review of the agency's QAPI program on 4/7/22, it was noted that the program failed to develop and initiate any performance improvement activities as part of their QAPI program, and the agency failed to follow their QAPI policies. During an interview on 4/7/22 at 9:00 a.m., the administrator (Adm#1) and the clinical manager (CM#1) acknowledged the above findings.

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 interview and record review, it was determined the Agency (HHA) failed to initiate any performance improvement activities within their Quality Assessment Performance Improvement (QAPI) program that focused on high risk, high volume or problem prone areas, Resulting in the potential for agency issues to go unresolved in high risk, high volume or problem prone areas that could affect all patients served by the agency. Findings include: During review of the agency's QAPI program on 4/7/22, it was discovered that the program failed to develop and initiate any performance improvement activities as part of their QAPI program that focused on high risk, high volume or problem prone areas. During an interview on 4/7/22 at 9:00 a.m., the administrator (Adm#1) and the clinical manager (CM#1) acknowledged the above findings.

Incidence, prevalence, severity of problems CFR(s): 484.65(c)(1)(ii) (ii) Consider incidence, prevalence, and severity of problems in those areas; and This ELEMENT is not met as evidenced by: Based on interview and record review, it was determined the Agency (HHA) failed to initiate any performance improvement activities within their Quality Assessment Performance Improvement (QAPI) program that considered incidence, prevalence, and severity of problems in identified areas of focus, resulting in the potential for the rendering of substandard care and unmet care needs. Findings include: During review of the agency's QAPI program on 4/7/22, it was discovered that the program failed to develop and initiate any performance improvement activities as part of their QAPI program. Due to the agency having no active performance improvement activities, the agency was unable to consider incidence, prevalence, and severity of problems in identified areas of focus. During an interview on 4/7/22 at 9:00 a.m., the administrator (Adm#1) and the clinical manager (CM#1) acknowledged the above findings.

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 interview and record review, it was determined the Agency (HHA) failed to initiate at least one performance Improvement Project (PIP) within their Quality Assessment Performance Improvement (QAPI) program, resulting in the potential for the rendering of substandard care and unmet care needs. Findings include: During review of the agency's QAPI program on 4/7/22, it was noted that the program failed to develop, have an on-going, or completed PIP, including an infection control project, as part of their QAPI program. During an interview on 4/7/22 at 9:00 a.m., the administrator (Adm#1) and the clinical manager (CM#1) acknowledged the above findings.

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 document review and interview, it was determined the Governing Body failed to ensure that the agency had an ongoing, active and functioning Quality Assessment and Performance Improvement (QAPI) program that fulfilled all the regulatory requirements of this section, that addressed priorities for improved quality of care and patient safety and was evaluated for effectiveness, resulting in the potential to adversely affect the quality of care to all patients receiving services. Findings include: During review of the QAPI binder on 4/7/22, it was discovered that the agency's governing body failed to ensure there was an ongoing QAPI program that met the requirements of this section. During an interview on 4/7/22 at 9:00 a.m., the administrator (Adm#1) and the clinical manager (CM#1) acknowledged the above findings.

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 record review and interview, the agency failed to utilize Infection Control standards during the provision of care and services for 1 (MR #5) of 1 patient observed during a home visit, from a total of 7 sampled records reviewed, resulting in the potential for the development and spread of infection G682); and, failed to maintain and document infection control tracking for employees, failed to gather infection control data, failed to analyze infections and track infection trends (G-684); The cumulative effect of these systemic problems resulted in the agency's inability to improve patient care, health outcomes, patient safety, and the agency's overall care performance. 1. The employee infection tracking sheet for 2020 and 2021 were blank. There was no infection control data provided for the year 2020 or 2021. There was no infection analysis for 2020 or 2021, and there was no trend tracking for either year, (G-684). The Physical Therapist failed to utilize professional standards in Infection Control during the provision of therapy services (G682).

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 observation, interview and record review, the Physical Therapist failed to utilize Infection Control standards during the provision of care and services for 1 (MR #5) of 1 patient observed during a home visit, from a total of 7 sampled records reviewed, resulting in the potential for the development and spread of infection. Findings include: Policy: "Infection Control Program" undated stated, "The agency implements policies and procedures to prevent the occurrence or spread of infection. Prevention strategies are incorporated into the patient education plan." MR #5: The patient's start of care (SOC) was 2/21/22 with diagnoses that included Paraplegia, Atherosclerotic Heart Disease and Peripheral Vascular Disease. On 4/4/22 at 12:30 p.m., during a scheduled home visit with the Physical Therapist (PT #1), the following was observed. PT #1 performed therapy exercises on the patient's upper and lower extremities. It was noted that PT #1 was not wearing gloves. After working with the patient's upper and lower extremities, PT #1 stated he would assist the patient to stand. PT #1 proceeded to look through his work bag for a gait belt (used to assist with ambulation). It was noted that PT #1 failed to wash his hands or make use of his hand sanitizer prior to looking into the bag. PT #1 placed his hands in all compartments of his work bag in an attempt to locate the gait belt. During the search, (PT #1) was queried as to which side of his work bag was designated the clean versus dirty side and reported, "The outer pocket is the dirty side." PT #1 contaminated all compartments of his work bag. Upon completion of the visit, PT #1 wiped his equipment (Blood pressure equipment, thermometer..) and placed them in the contaminated compartments. During an interview, PT #1 was queried about the identified infection control issues, yet was unable to respond. These findings were reviewed with and acknowledged by the Administrator (Adm #1) who was also the therapist (PT #1) for this visit.

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 record review and interview, it was determined that the Agency (HHA) failed to coordinate an agency-wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases as a part of the HHA's Quality Assessment Performance Improvement (QAPI) program, resulting in the potential for increased, untreated infections among the Agency's patient and staff population. Findings include: **Agency policy: Infection Control Program pg. 701, undated. "The infection control program includes the following process: Surveillance; The agency collects data about infections..., identification; data is used to identify problems or undesirable trends..., prevention; implement policies and procedures to prevent the occurrence or spread of infection.., and reporting; patient and staff infections are reported internally and externally, as required by law and regulation." During review of the agency's Infection Control program on 4/7/22, it was discovered that the HHA's Infection Control Employee Tracking sheet was blank, there was no infection control data for the year 2020 or 2021, no analysis for each year of infections, and no trend tracking included in the program. The agency failed to follow their own policies regarding an infection control program. During an interview on 4/7/22 at 9:00 a.m., the administrator (Adm#1) and the clinical manager (CM#1) acknowledged the above findings.

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 record review and interview, it was determined that the Agency failed to ensure the Registered Nurse performed complete assessments and re-assessments of the patient's health status and needs in 1 (MR #6) of 1 record of a patient with a diagnosis of Congestive Heart Failure, from of a total sample of 7 records reviewed resulting in the potential for unidentified health concerns and poor patient outcomes. Findings included: On 4/4/22 during the Entrance Conference, the Clinical Manager (CM #1) was queried about the process for assessing patients with Congestive Heart Failure and reported, "I have my own scale that I use for weighing the patient and I use a tape measure to measure edema. I also document +1 and +2 (finger pressure used to assess edema)." MR #6: The patient's Start of Care (SOC) was 5/24/21with diagnoses that included Congestive Heart Failure (CHF) and Hypertension. During a review of the clinical record on 4/4/22 at 3:12 p.m., it was noted that the Initial Comprehensive Assessment, completed by the RN, dated 5/24/21, documented that the patient had "Swollen painful joints, and edema (+1) bilateral feet," and a documented baseline weight of 179 pounds. There was no tape measurement of edema as stated by CM #1 and no indication if the patient's weight was actual or reported. According to the skilled nurses (SN) visit notes dated 5/31/21, 6/7/21, 6/14/21 and 6/23/21, the patient's weight remained the same, at 179 pounds. It was also noted that the SN consistently documented that the patient had +1 edema bilateral lower extremities. There was no measurement of the patient's edema. During an interview on 4/6/22 at 1:53 p.m., CM #1 was queried about the accuracy of the patient's documented weights and reported, "The weights carried over from the initial assessment." When queried about the lack of measurement of edema, CM #1 offered no response. The Nurse failed to accurately assess/reassess the patient's health status. These findings were reviewed with and confirmed by the Administrator (Adm #1) and the Clinical Manager (CM #1) during the above interview on 4/6/22 at 1:53 p.m.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on observation, interview and record review, it was determined that the Agency failed to ensure the Physical Therapist provided services as ordered in the Plan of Care for 1 (MR #5) of 1 patient with Physical Therapy services ordered, who was observed during a home visit, resulting in the potential for inappropriate application of therapy exercises, physical decline, and unmet care needs. Findings include: MR #5: The patient's start of care (SOC) was 2/21/22 with diagnoses that included Paraplegia and Atherosclerotic Heart Disease. During the record review on 4/4/22 at 11:15 a.m., it was noted that the Plan of Care (POC) ordered the Physical Therapist to provide a "HEP (home exercise plan) to do 1 -2x/daily as instructed." These exercises were to be performed by the assigned caregiver. On 4/4/22 at 12:30 p.m., a home visit was conducted with the Physical Therapist/Administrator (Adm #1). During the visit, the patient's home admission packet was reviewed and noted to be void of any HEP instructional information sheet. The patient resided in a group home type setting. The person over the house was queried about his knowledge of the HEP. Adm #1 interjected and reported, "I'm sure I have one but I may have left it." The gentleman in charge then replied, "I do some exercises with him (patient) mostly stretching." The Physical Therapist failed to provide the patient with a HEP in accordance with the plan of care. These findings were reviewed with and acknowledged by Adm #1 during the visit.

Ensures qualified pre-designated person CFR(s): 484.105(b)(2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section. This ELEMENT is not met as evidenced by: Based on interview, the Agency failed to ensure a qualified alternate, was authorized in writing by the Administrator and the governing body, to function in the Administrator's absence, resulting in the potential for uncoordinated Agency functions. Findings include: On 4/7/22 at 11:00 a.m., the Administrator (Adm #1) was queried as to whether the Agency had an Alternate Administrator or a qualified alternate to act on his (Adm #1) behalf during his absence and reported, "No. I don't currently have one." The Agency failed to ensure a qualified alternate had been appointed by the Governing Board to act in the absence of the Administrator.

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 record review and interview, the agency failed to ensure that discharge and summaries were complete, provided the patient's current health status at the time of discharge, documented progress toward goals, provided an updated medication list and were sent to the physician in 2 of 2 records (MR #'s 4, 6) who were discharged from a total of 7 records reviewed, resulting in the potential for unidentified continuing health care concerns and unmet care needs. Findings include: MR#4: The start of care (SOC) was dated 9/1/21-10/30/21, with diagnoses that included difficulty walking, weakness and pain. During record review on 4/6/22, it was observed that the discharge summary failed to document the patient's discharge condition regarding all listed diagnoses, outcomes towards meeting goals, frequency of services provided, and medications at discharge. During an interview on 4/7/22 at 9:00 a.m., the administrator (Adm#1) and the clinical manager (CM#1) acknowledged the above findings. MR #6: The patient's start of care (SOC) was 5/24/21 with diagnoses that included Acute on Chronic Congestive Heart Failure, Hypertension and Diabetes Mellitus. During the record review on 4/4/22 at 3:12 p.m. it was noted that the patient received Skilled Nursing (SN) and Physical Therapy (PT) services. The patient discharged from SN on 6/23/21. The SN discharge Summary dated 6/23/21 failed to include a summary of the course of care provided with responses, health status at the time of discharge and documented evidence that the summary was sent to the Physician within 5 days of the date of discharge. The summary was void of the patient's weight, blood sugar and level of edema at the time of discharge. Further review revealed that PT discharged the patient on 7/21/21. The Physical Therapist failed to document a summary of care provided. Additionally, there was no documented evidence that the summary had been forwarded to the Physician within 5 days of the date of discharge. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Clinical Manager (CM #1) during an interview on 4/6/22 at 1:53 p.m.

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 record review and interview, the agency failed to include signatures on the medication reconciliation form for 2 records (MR# 2 and 3) from a total of 7 records reviewed, resulting in the potential for adverse medication interactions for agency patients. Findings include: MR #2: The patient's start of care (SOC) was 3/27/22, with diagnoses that included diabetes, falls and ataxia. During record review on 4/5/22, it was discovered that the patient's Medication reconciliation was not signed. Due to the lack of a signature, it is unclear if a registered nurse performed the medication reconciliation. MR #3: The patient's start of care (SOC) was 3/29/22, with diagnoses that included polyosteoarthritis, cerebral infarct, polyneuropathy and hypertension. During record review on 4/5/22, it was discovered that the patient's Medication reconciliation was not signed. Due to the lack of a signature, it is unclear if a registered nurse performed the medication reconciliation on this physical therapy (PT) only case. During an interview on 4/7/22 at 9:00 a.m., the administrator (Adm#1) and the clinical manager (CM#1) acknowledged the above findings.