Every finding on record at Community Home Health Care of Michigan, Inc

On 5/13/25, through 5/16/25, an Emergency Preparedness standard survey was conducted by the Michigan Department of Licensing and Regulatory Affairs. During the survey, Community Home Care Services was found to be out of compliance with requirements for participation in Medicare at 42 CFR 484.102 Emergency Preparedness.

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 5 out of 5 annual Emergency Preparedness (EP) testing drills reviewed included all documentation including staff participation and event specific information regarding details of the exercise, resulting in the potential for an unprepared staff response during an emergency. Findings include: A review of agency policy titled “Testing Program for Emergency Operation Plan (EOP)” (revised January 2020) revlealed, “Exercises will review and confirm: Staff communication procedures and content; Assigned staff roles related to essential response functions…” The agency’s Emergency Preparedness (EP) information was reviewed on 5/15/25. During review of the agency’s testing exercises, it was determined the tabletop tornado drill (dated 3/19/25), actual blizzard emergency (dated 12/5/24), actual severe storm emergency (dated 6/25/24), actual blizzard emergency (dated 2/23/23), and actual blizzard emergency (dated 12/22/23) failed to include documentation of staff participation (who participated and how) and failed to include documentation of event specific information regarding what occurred during each exercise related to what was supposed to occur based on agency policy and procedure The Administrator (Adm-1) reviewed and acknowledged the findings listed above during an interview on 5/16/25 at 10:04 AM.

A Medicare recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs on 5/13/25 through 5/16/25 at: Community Home Care Services 183 W. River Valley Dr. Newaygo, MI 49337 At the time of the survey, the agency did not operate any branch locations. Clinical records reviewed included: 3 active records without home visits; 4 active records with home visits; and 3 discharge records for a total of 10 records. At the conclusion of the survey, the agency was determined to be out of compliance with requirements for the Conditions of Participation at 42 CFR 484: Home Health Agencies.

Payment from federally funded programs CFR(s): 484.50(c)(7)(i, ii, iii, iv) Be advised, orally and in writing, of- (i) The extent to which payment for HHA services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (ii) The charges for services that may not be covered by Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (iii) The charges the individual may have to pay before care is initiated; and (iv) Any changes in the information provided in accordance with paragraph (c)(7) of this section when they occur. The HHA must advise the patient and representative (if any), of these changes as soon as possible, in advance of the next home health visit. The HHA must comply with the patient notice requirements at 42 CFR 411.408(d)(2) and 42 CFR 411.408(f). This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure that 2 (P-8, P-9) of 10 overall patient planning of care records reviewed included informing the patient/caregiver in advance of potential payment charges, resulting in a lack of inclusion in planning, lack of informed consent, and unmet care needs. Findings include: A review of the agency policy: "Patient Admission Criteria" (Revised February 2021). The policy states, "13. During the initial visit, the admitting professional will: Explain and provide a copy of the Patient’s Bill of Rights/Responsibilities, Privacy Notice and advance directives…” Patient #8’s (P-8) Start of Care (SOC) was dated 4/17/25. The Plan of Care (POC) identified diagnoses of Ureteral Calculus, Urinary Tract Infection and Acute Kidney Infection. During record review on 5/15/25, it was noted that the signed “Consent for Treatment” was blank under the sections “Charges, Insurance pays, I pay, Co-Payment, and Deductible”. The agency failed to notify the patient in advance of possible payments required. Patient #9’s (P-9) Start of Care (SOC) was dated 4/11/25. The Plan of Care (POC) identified diagnoses of Right Buttock Pressure Ulcer Stage 2, Congestive Heart Failure and Chronic Kidney Disease. During record review on 5/15/25, it was noted that the signed “Consent for Treatment” was blank under the sections “Charges, Insurance pays, I pay, Co-Payment, and Deductible”. The agency failed to notify the patient in advance of possible payments required. The Administrator (ADM-1) reviewed and acknowledged the findings listed about in an interview on 5/16/25 at 12:25 pm.

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 notify the physician/practitioner the initial assessment to determine immediate care needs and home care eligibility would not be performed within 48 hours of referral in 1 (Patient #3) of 10 records reviewed, resulting in the potential for unidentified patient care needs. Findings include: Review of agency policy titled “Initial Assessments/Comprehensive Assessments” (revised April 2023) indicated, “In instances where the patient requests a delay in the start of care date, the Agency will need to contact the physician/practitioner to request a change in the start of care date and such change will be documented in the medial record.” Patient #3 (P-3): This 83-year-old patient was admitted to this home care agency on 3/20/25 with the diagnoses of surgical care following surgery on the genitourinary system (for kidney stones), urinary tract infection, cardiomyopathy, and type II diabetes mellitus. During record review on 5/13/25, it was noted the referral to start home care services was dated 3/15/25. Upon further review of the record, it was determined the initial assessment did not occur until 3/20/25 – 5 days after the date of referral. During an interview with the Administrator (Adm-1) on 5/16/25 at 10:04 AM, Adm-1 was asked about the reason for the late start. Adm-1 indicated the summary sections on the Outcome Assessment and Information Set (OASIS) dated 3/20/25 indicated, “He discharged home on 3/14/25. Admission performed at date and time of patient choosing PCP aware of admission date.” [sic] However, Adm-1 confirmed this was documented on 3/20/25 (the date of the late initial assessment) and was unable to provide evidence of the physician being notified prior to the late start. Adm-1 acknowledged the findings at the time of interview.

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 the comprehensive assessment included identification of duplicate drug therapy for 3 (P-1, P-9, P-10) of 10 records reviewed resulting in the potential for an undetected harmful medication related poor outcome for this patient. Findings include: Agency policy titled “Medication Reconciliation”, revised February 2021, was reviewed on 5/16/25. On page 1., it stated “The Agency will reconcile patient medications at the time of admission and on an ongoing basis in order to identify any potential adverse effects and drug reactions… any concerns or discrepancies will be reconciled by a RN with the patient’s physician/practitioner. Discrepancies include duplications…”. P-2: This 68-year-old was admitted to agency on 7/10/24 with diagnoses including paralysis of the left side following stroke; Emphysema (lung condition causing shortness of breath); and generalized arthritis. The medical record was reviewed on 5/15/25. During review of the Comprehensive Assessment dated 7/10/24, it was noted that the registered nurse (RN) completing the assessment marked that “issues” were identified during the medication review. There was no documentation identifying what issues were identified with the medication review. It was noted that the patient was prescribed 3 Nonsteroidal Anti-inflammatory (NSAID) medications (Aspirin, Ibuprofen, and Aleve). Upon review of the drug interactions for this patient using the agency’s electronic medical record (EMR) system, the duplication of (NSAID) medications was not displayed. The drug-to-drug interactions list for this patient’s medications did display moderate interactions between 5 medications (including the NSAID’s). On 5/15/25 at 11:46 a.m., an interview was conducted with the Administrator (Adm-1). Adm-1 was asked if the agency EMR system identified duplicate drug therapies. After investigating the question, Adm-1 stated that the EMR system does not display duplications in drug therapy, and it was left to the admitting clinician to determine if duplications existed. There was no documented evidence in the Comprehensive Assessment or agency Medication Profile for this patient that the RN identified the duplication of drug therapy for the 3 NSAID medications prescribed. There was no evidence that the RN reviewed the NSAID’s as a duplicate drug therapy with the physician as agency policy requires. Adm-1 acknowledged this finding at the time that it was found. P-9: The Start of Care (SOC) was dated 4/11/25. The Plan of Care (POC) identified diagnoses of Right Buttock Pressure Ulcer Stage 2, Congestive Heart Failure and Chronic Kidney Disease. During record review on 5/15/25, section M2001 of the "Comprehensive Assessment" dated 4/11/25 and completed by the Registered Nurse (RN), documented "Issues found during review." M2003 was marked “Yes” regarding “Medication Follow-up: Did the agency contact a physician by midnight of the next calendar day and complete prescribed/recommended actions in response to the identified potential clinically significant medication issues?” There was no documentation identifying what issues were identified with the medication review. Additionally, It was noted that the patient was prescribed 6 Cardiovascular agent medications (Amlodipine, Doxazosin, Furosemide, Lovastatin, Metoprolol Succinate and Spironolactone) and 3 Antihypertensive medications (Amlodipine, Doxazosin and Metoprolol Succinate). Review of the drug interactions within the agency’s Electronic Medical Record (EMR) system, the duplication of Cardiovascular agents and Antihypertensive medications was not displayed. There was no documented evidence in the Comprehensive Assessment or agency Medication Profile for this patient that the RN identified the duplication of drug therapy for the 6 Cardiovascular agent and 3 Antihypertensive medications prescribed. There was no evidence that the RN reviewed the duplicate drug therapy with the physician as agency policy requires. P-10: The Start of Care (SOC) was dated 11/18/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure and Diabetes Type 2. During record review on 5/13/25, section M2001 of the "Comprehensive Assessment" dated 11/18/24 and completed by the RN, documented "Issues found during review." M2003 was marked “Yes” regarding “Medication Follow-up: Did the agency contact a physician by midnight of the next calendar day and complete prescribed/recommended actions in response to the identified potential clinically significant medication issues?” There was no documentation identifying what issues were identified with the medication review. Additionally, It was noted that the patient was prescribed 5 Cardiovascular agent medications (Amlodipine, Atorvastatin, Hydralazine, Nitroglycerin and Torsemide). Review of the drug interactions within the agency’s EMR system, the duplication of Cardiovascular agents and Antihypertensive medications was not displayed. There was no documented evidence in the Comprehensive Assessment or agency Medication Profile for this patient that the RN identified the duplication of drug therapy for the 5 Cardiovascular agent medications prescribed. There was no evidence that the RN reviewed the duplicate drug therapy with the physician as agency policy requires. These findings were reviewed with and acknowledged by Adm-1 (Administrator) during an interview on 5/16/25 at 12:35 pm.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure missed visits altering the plan of care frequency were communicated with the doctor per agency policy in 3 (Patient #2, 3, 4) of 10 records reviewed, resulting in the potential for unmet patient care needs and poor patient outcomes. Findings include: Patient #2 (P-2), a 68-year-old was admitted to agency on 7/10/24 with diagnoses including paralysis of left side following stroke; Emphysema (lung condition causing shortness of breath); and generalized arthritis. The medical record was reviewed on 5/15/25. During review it was noted that the patient was recertified for home health services on 11/7/24 and included orders for Physical Therapy (PT) one time per week for 9 weeks. PT made 6 visits in 9 weeks and missed 3 visits (between 11/7/24 and 1/2/25). There were no visits entered in the week beginning 11/24/24 and no documentation that an attempt was made to reschedule the visit within those 7 days. There were no visits for 2 weeks straight on the weeks beginning 12/17/24 and 12/24/24 and no documentation that attempts were made to reschedule the visits within those 14 days. The PT entered a “Missed Visit Note” for each of the 3 scheduled visits within those 3 weeks with no PT services. The Missed Visit Note was a form with prompts such as “Physician Notified”; “Case Manager Notified”, “Date of Notification” and “Additional Comments”. The note gave space for the clinician to write a response after the prompts. It was noted the PT entered the word “Fax” after the prompts of “Physician Notified” and “Case Manager Notified”. All 3 missed visit notes failed to include a fax number for the physician, a date of notification for either the physician or the clinical manager, and what the physician response/instruction was following notification. This finding was reviewed and acknowledged by the Administrator (Adm-1) during an interview on 5/16/25 at 10:50 a.m. A review of agency policy titled “Plan of Care – CMS #485 and Physician/Practitioners Orders” (revised April 2023) revealed, “…If the Agency misses a visit or a treatment or services as required by the plan of care, which results in any potential for clinical impact upon the patient, then the Agency must notify the responsible physician/practitioner of such missed treatment or service. The physician/practitioner decides whether the treatment or service may be skipped or whether additional intervention is required by the Agency due to the clinical impact on the patient.” Patient #3 (P-3): This 83-year-old patient was admitted to this home care agency on 3/20/25 with the diagnoses of surgical care after surgery on the genitourinary system (for kidney stones), urinary tract infection, cardiomyopathy, and type II diabetes mellitus. During record review on 5/14/25, it was determined a missed visit for physical therapy was documented on 5/8/25 as the patient “declined alternate staff” when his regular physical therapist was not available. According to the missed visit documentation, the physician was notified via fax, however, there was no documentation regarding the physician’s response per agency policy above. Patient #4(P-4): This 72-year-old patient was admitted to this home health agency on 2/21/25 with the diagnoses of malignant neoplasm of the brain and left lower leg deep vein thrombosis (blood clot). During record review on 5/15/25, it was determined a missed visit for physical therapy was documented on 3/24/25 as the patient “declined alternate staff” when his regular physical therapist was not available. According to the missed visit documentation, the physician was notified via fax, however, there was no documentation regarding the physician’s response per agency policy above. The Administrator (Adm-1) reviewed and acknowledged the findings listed above during an interview on 5/16/25 at 10:04 AM. A review of the agency policy: "Plan of Care – CMS #485 and Physician/Practitioner Orders" (Revised April 2023). The policy states, "4. The individualized plan of care must include the following: The frequency and duration of visits to be made. 20. Care and services provided will be provided according to physician/practitioner orders. Orders are current and updated. 30. The patient’s orders for treatments and services are the foundation of the plan of care. If the Agency misses a visit or a treatment or services as required by the plan of care, which results in any potential for clinical impact upon the patient, then the Agency must notify the responsible physician/practitioner of such missed treatment or service. The physician/practitioner decides whether the treatment or service may be skipped or whether additional intervention is required by the Agency due to the clinical impact on the patient.” Patient #9’s (P-9) Start of Care (SOC) was dated 4/11/25. The Plan of Care (POC) identified diagnoses of Right Buttock Pressure Ulcer Stage 2, Congestive Heart Failure and Chronic Kidney Disease. During record review on 5/15/25, it was noted that Physical Therapy (PT) completed an evaluation on 4/14/25 with the ordered frequency of 2w8 (2 times a week for 8 weeks), 1w1. The week of 4/27/25 to 5/3/25 (Week 4) the PT completed 1 of 2 scheduled visits on 5/2/25 with no documented evidence of completing the second visit. Additionally, the PT documented missed visits on 5/9/25 (Friday) and 5/12/25 (Monday) with no attempt to complete the frequency as ordered. For both missed visits, the PT documented, “Physician Notified: Fax. Case Manger Notified: Fax.” There was no documented evidence of the fax numbers used to communicate with the physician and their response per agency policy. Furthermore, the POC ordered Home Health Aide (HHA) at a frequency of 2w7 on 4/11/25. The week of 4/13/25 to 4/19/25 the HHA completed 0 of 2 scheduled visits with no documented evidence of missed visits. The HHA failed to complete the visits as ordered. The Administrator (ADM-1) reviewed and acknowledged the findings listed about in an interview on 5/16/25 at 12:40 pm.

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 that orders for frequency and duration of visits were included on the Plan of Care in 2 of 7 records reviewed (Patient #5, 7); and the agency failed to ensure the goals on the Plans of Care were objectively measurable to determine the patient's progress towards obtaining the goals in 8 of 10 records (Patient #1, 4, 5, 6, 7, 8, 9, 10) reviewed resulting in the inability to determine the patient's progress towards obtaining the goals. Findings included: Patient #1 (P-), a 95-year-old was admitted to agency on 1/17/24 with diagnoses including Crohn’s disease (inflammatory bowel disease) and a suprapubic cystostomy (surgical opening of the urinary bladder to drain urine). The Plan of Care (POC) dated 5/11/25 to 7/9/25 was reviewed on 5/14/25. During review, the following examples of skilled nursing (SN) goals for care were noted: Patient’s medical condition will remain stabilized within the cert period; The patient's pain will be managed as verbalized by the patient within 9 -weeks; Patient will be free of signs and symptoms of heart failure during the certification period. It was unclear how these goals would be objectively measured to determine progress toward the goals. This finding was reviewed and acknowledged by the Administrator (Adm-1) during an interview on 5/16/25 at 10:50 a.m. Patient #4 (P-4): This 72-year-old patient was admitted to this home health agency on 2/21/25 with the diagnoses of malignant neoplasm of the brain and left lower leg deep vein thrombosis (blood clot). During record review on 5/15/25, the following examples of skilled nursing goals were listed on the plan of care: -Patient’s cardiac status will remain within normal limits for this patient without further progression of complications during the certification period. -Patient/caregiver will be knowledgeable of anticoagulation/bleeding precautions and appropriate actions to take within 4 weeks. -The patient’s pain will be managed as verbalized by the patient during cert period. -Patient/caregiver will be knowledgeable of DVT disease process and appropriate actions to take within 4 weeks. These goals lack measurable, quantifiable data to assess progress towards meeting them. The Administrator (Adm-1) reviewed and acknowledged the findings listed above during an interview on 5/16/25 at 10:04 AM. Patient #8’s (P-8) Start of Care (SOC) was dated 4/17/25. The Plan of Care (POC) identified diagnoses of Ureteral Calculus, Urinary Tract Infection and Acute Kidney Infection. During record review on 5/15/25, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Patients medical condition will remain stabilized within certification period.” Additionally, another goal stated, “Patient/caregiver will comply with prescribed medications during cert period.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. Patient #9’s (P-9) Start of Care (SOC) was dated 4/11/25. The Plan of Care (POC) identified diagnoses of Right Buttock Pressure Ulcer Stage 2, Congestive Heart Failure and Chronic Kidney Disease. During record review on 5/15/25, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Patient will receive appropriate wound care as ordered by physician during plan of care.” Additionally, another goal stated, “Patient will be free from contracting COVID-19 through certification period.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. Patient #10’s (P-10) Start of Care (SOC) was dated 11/18/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure and Diabetes Type 2. During record review on 5/13/25, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Patient will be free of exacerbation from --- disease process --- within 60 days.” Additionally, another goal stated, “Patient will be free from contracting COVID-19 through certification period.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. The Administrator (ADM-1) reviewed and acknowledged the findings listed about in an interview on 5/16/25 at 12:10 pm. ***Agency Policy: Plan of Care-CMS #485 and Physician/Practitioners Orders. The policy states, "The individualized plan of care must include the following: The frequency and duration of visits to be made." ***Agency Policy: Plan of Care-CMS #485 and Physician/Practitioners Orders: The policy states, "The individualized Plan of Care must include the following: "Patient-specific interventions and education, measurable outcomes and goals identified by the Agency and patient." Patient #5's (P-5) Start of Care was dated 1/31/2025. The Plan of Care for the certification period 4/1/2025 to 5/3/2025 identified diagnoses of Diabetes Type 2 with foot ulcer, non-pressure chronic ulcer of right heel and midfoot with necrosis, Encounter for surgical after care, Coronary Artery Disease, and Hypertensive heart disease with heart failure. The patient was receiving Skilled Nursing (SN) services 2 times weekly, however, there was no information found in the record that included orders for the duration of visits. The physician failed to include orders for duration of visits on the Plan of Care. In addition, upon review of the Plan of Care, it was noted the goals on the Plan of Care were not objectively measurable to determine the patient's progress towards obtaining the goals. Examples included: "Patient/Caregiver will verbalize understanding of Ambulation safety and fall precautions within certification period" {sic}; "Patient/caregiver will be knowledgeable about skin/foot care and breakdown prevention within cert period {sic}"; Patient will elevate legs while sitting and watch for any weight gain and how and when to seek medical assistance; Patient/Caregiver will verbalize understanding of medication safety techniques within cert period {sic}." These goals are not objectively measurable to determine the patient's progress towards obtaining the goals. P-6's (P-6) Start of Care (SOC) was dated 3/7/2025. The Plan of Care (POC) for the certification Period 3/7/2025 to 5/5/2025 identified diagnoses of Trochanter's Bursitis of Left Hip, Alzheimer's Disease, Atrioventricular Blockage, Coronary Artery Disease, Dizziness and Giddiness. Upon review of the Plan of Care, it was noted the goals on the POC were not objectively measurable to determine the patient's progress towards obtaining the goals. Examples included: "Patient will have assistance with personal care and IADLS (Instrumental Activities of Daily Living) with the assistance of the home health aide during plan of care; Patient will remain neat, clean and odor free throughout certification period; Patient's safety will be enhanced throughout the home care service as evidenced by no injuries through 9 weeks; Patient will be free from any falls during episode." These goals are not objectively measurable to determine the patient's progress towards obtaining the goals. P-7's (P-7) Start of Care was dated 1/31/2025. The Plan of Care for the certification period 4/1/2025 to 5/30/2025 identified diagnoses of Diabetes type 2, non-pressure chronic ulcer of right heel and midfoot with necrosed bone; Encounter for surgical after-care following surgery on the circulatory system, Atherosclerotic Heart Disease of Native Coronary Artery with unspecified Angina Pectorus; Hypertensive Heart Disease with Heart Failure; Chronic Combined Systolic and Diastolic Heart Failure. The Plan of Care included orders for Skilled Nursing Services two times a week. However, there was no information found in the record that included orders for duration of Skilled Nursing Services. In addition, the Plan of Care for the certification period 4/1/2025 to 5/30/2025 identified diagnoses of Diabetes type 2, non-pressure chronic ulcer of right heel and midfoot with necrosed bone; Encounter for surgical after-care following surgery on the circulatory system, Atherosclerotic Heart Disease of Native Coronary Artery with unspecified Angina Pectorus; Hypertensive Heart Disease with Heart Failure; Chronic Combined Systolic and Diastolic Heart Failure. The patient was receiving Skilled Nursing Services two times a week. Upon review of the Plan of Care it was noted the goals on the Plan of Care were not objectively measurable to determine the patient's progress towards obtaining the goals. Examples include: "Patient/Caregiver will verbalize understanding of ambulation safety and fall precautions within cert period; Patient/caregiver will be knowledgeable about skin/foot care and breakdown prevention within cert period; Patient will maintain appropriate nutrition/hydration status to avoid wound healing complications within certain period {sic}. These goals are not objectively measurable to determine the patient's progress towards obtaining the goals. The Administrator (Adm-1) reviewed and acknowledged the findings listed above during an interview on 5/16/25 at 11:35 AM.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to promptly notify the Physician concerning a vital sign outside of the specified reportable parameters for 1 (P-10) of 10 records reviewed, resulting in a potential poor clinical outcome. Findings include: A review of the agency policy: "Plan of Care – CMS #485 and Physician/Practitioners Orders" (Revised April 2023). The policy states, "Procedure: 20. Care and services provided will be provided according to physician/practitioner orders. Orders are current and updated. 21. Drug, services and treatments are administered by staff only as ordered by physician/practitioner.” Patient #10’s (P-10) Start of Care (SOC) was dated 11/18/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure and Diabetes Type 2. During record review on 5/13/25, it was noted that the POC noted “Parameters to Notify Physician” stating, “Pulse Ox The was no documented evidence of the PT reporting the low O2 reading. The PT failed to notify the physician as per policy. The Administrator (ADM-1) reviewed and acknowledged the findings listed about in an interview on 5/16/25 at 12:10 pm.

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 agency failed to ensure the home health aide followed accepted standards of practice in infection control according to agency policy in 1 (P-1) of 1 observation in which a joint survey home visit was conducted with a home health aide, potentially resulting in transmission of infectious disease to this patient or any of the agency’s 143 current patients that are receiving, or may request to receive home health aide services. Findings include: Agency policy titled “Standard Precautions”, revised April 2023, was reviewed on 5/16/25. On page 3., it stated “5. Perform hand hygiene after removing gloves.” Patient #1 (P-1), a 95-year-old was admitted to agency on 1/17/24 with diagnoses including Crohn’s disease (inflammatory bowel disease) and a suprapubic cystostomy (surgical opening of the urinary bladder to drain urine). On 5/14/25 a joint home visit was conducted with the home health aide (HHa) at 8 a.m. The HHa was scheduled to perform a shower with P-1 during the visit. Upon arrival, the HHa was observed performing hand hygiene after reaching her hand (dirty) into her shirt pocket to retrieve hand sanitizer. While preparing for the shower procedure, and after touching many household items, the HHa was observed reaching her hand (dirty) in her shirt pocket to retrieve a pair of gloves. The HHa was observed removing and discarding a dirty pair of gloves and reaching her hand (dirty) in her shirt pocket to retrieve another pair of gloves. The HHa did not perform hand hygiene after removing the dirty pair of gloves and putting on the new pair. After completing the showering tasks, the HHa removed/discarded the dirty gloves and then reached her hand (dirty) in her shirt pocket for the hand sanitizer. The HHa performed hand hygiene and then put the hand sanitizer back in her pocket. The findings were reviewed with the Administrator (Adm-1) during an interview on 5/16/25 at 10:50 a.m. Adm-1 was asked for a policy describing the procedure for when staff should place items for patient care in the pockets of their clothing. Adm-1 stated that although policy does not describe this practice, all staff are given a bag to hold/retrieve needed hand sanitizer and patient care supplies while at a patient’s home and are instructed on the use of the items/bag. Adm-1 stated that staff should not be placing patient care items in their clothing pockets and acknowledged the above findings.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure the home health aide provided only the services which were included in the Plan of Care in 1 (P-1) of 1 observation for which a joint home visit was conducted with the home health aide, resulting in unsafe care and the potential for a poor patient outcome. Findings include: Patient #1 (P-1), a 95-year-old was admitted to agency on 1/17/24 with diagnoses including Crohn’s disease (inflammatory bowel disease) and a suprapubic cystostomy (surgical opening of the urinary bladder to drain urine through a catheter). On 5/13/25, the Comprehensive Recertification Assessment dated 5/7/25 was reviewed and revealed that P-1 was a high fall risk, legally blind, and used a wheelchair or walker for ambulation. During review of the Aide Plan of Care (care instructions for the aide), it was noted under the heading “Activities: Assist with Ambulation/Assistive Device Use” that the assistive ambulation device marked with a check box included “Wheel Chair” and a note was entered next to the checked box which stated, “Assist as needed”. There were no other instructions given for how the patient transferred, ambulated, or other devices (such as a walker). On 5/14/25 a joint home visit was conducted with the home health aide (HHa) at 8 a.m. The HHa was scheduled to perform a shower with P-1 during the visit. Upon entrance into the home, P-1 was observed sitting in a wheelchair in the kitchen. When the HHa told P-1 that everything was ready for the shower, P-1 began to self-propel the wheelchair toward the bathroom (off the living room). There was a narrow entrance to the bathroom due to clutter, so P-1 stopped the wheelchair a few feet from the bathroom, stood up, gathered up the suprapubic catheter in one hand, and began to walk into the bathroom while the HHa watched. There was no assistive device used, and there was no assistance from the HHa. P-1 prepared for entering the shower by undressing while sitting on the toilet and then walked a few steps to the tub/shower with no assistance or assistive devices. After the shower was complete and P-1 was redressed, P-1 walked unassisted a few feet back to the wheelchair. The HHa was asked if the patient used a device for assistance when walking. The HHa replied “no” and stated that P-1 could walk into the bathroom. The HHa did not provide only the services as written in the Aide Plan of Care (assist with wheelchair). The Administrator (Adm-1) reviewed and acknowledged the findings above during an interview on 5/16/25 at 10:50 a.m.

Duties of a HH aide CFR(s): 484.80(g)(3) The duties of a home health aide include: (i) The provision of hands-on personal care; (ii) The performance of simple procedures as an extension of therapy or nursing services; (iii) Assistance in ambulation or exercises; and (iv) Assistance in administering medications ordinarily self-administered. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure the home health aide provided only a passive role in assisting the patient with a medication in 1 (P-1) of 1 observation for which a joint home visit was conducted with the home health aide, potentially resulting in unintended consequences of a medication misadministration. Findings include: Patient #1 (P-1), a 95-year-old was admitted to agency on 1/17/24 with diagnoses including Crohn’s disease (inflammatory bowel disease) and a suprapubic cystostomy (surgical opening of the urinary bladder to drain urine through a catheter). The Aide Plan of Care (care instructions for the aide) was reviewed on 5/13/25 and it was noted that the instructions included the following skin care related duties: Skin Care (under “Grooming”); Report to SN (skilled nurse) any new skin or wound breakdown; apply skin barrier. On 5/14/25 a joint home visit was conducted with the home health aide (HHa) at 8 a.m. The HHa was scheduled to perform a shower with P-1 during the visit. After the shower the HHa was observed while applying (sprinkling) a powder around the stoma (cystostomy opening) on the patient’s abdomen. It was noted the powder was a physician prescribed antifungal medication called Nystatin Powder. The HHa was asked what the powder was and stated it was Nystatin and that the nurse knew she put it on P-1. Upon detailed review of the medical record on 5/14/25, it was noted that the nurse instructed the patient’s caregiver on use and application of the Nystatin Powder during a visit on 2/4/25. The Nystatin Powder was on the medication profile and the instructions included: small amount, external, new, powder until healed. The HHa actively applied a prescription medication. The findings were reviewed with the Administrator (Adm-1) during an interview on 5/16/25 at 10:50 a.m. Adm-1 was asked what was meant by “skin barrier” on the Aide Plan of Care. Adm-1 stated that a skin barrier was an over the counter (non-prescribed) ointment or cream. Adm-1 agreed that Nystatin was a physician prescribed medication which should not be applied by the HHa.

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 contained all interventions, treatments, services, and responses to treatment in 2 (Patient #3, 4) of 10 records reviewed, resulting in an incomplete medical record. Findings include: P-3: This 83-year-old patient was admitted to this home care agency on 3/20/25 with the diagnoses of surgical care after surgery on the genitourinary system (for kidney stones), urinary tract infection, cardiomyopathy, and type II diabetes mellitus. During record review on 5/14/25, it was noted the physical therapy notes (dated 4/3/25, 4/10/25, and 4/23/25) each listed the exercises performed by the patient, however, a generalized range of repetitions was given below (5-10, 7-10, etc). It is unclear how many repetitions of each exercise the patient performed; therefore, the record is an inaccurate and incomplete representation of the patient’s treatment. Patient #4 (P-4): This 72-year-old patient was admitted to this home health agency on 2/21/25 with the diagnoses of malignant neoplasm of the brain and left lower leg deep vein thrombosis (blood clot). During record review on 5/15/25, it was noted the physical therapy notes (dated 2/24/25, 2/26/25, 3/3/25, 3/5/25, 3/17/25, 3/31/25, and 4/9/25 ) each listed the exercises performed by the patient, however, a generalized range of repetitions was given below (5-10, 10-10, etc). It is unclear how many repetitions of each exercise the patient performed; therefore, the record is an inaccurate and incomplete representation of the patient’s treatment. Additionally, upon review of the occupational therapy note dated 3/5/25, it was documented that the occupational therapist, “Educated on exercises to complete with theraputty” and “Provided hand exercises to address fine motor coordination.” There were no further details regarding what specific exercises or instructions were given; therefore, the record is an inaccurate and incomplete representation of the patient’s treatment. The Administrator (Adm-1) reviewed and acknowledged the findings listed above during an interview on 5/16/25 at 10:04 AM.

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, policy review, and interview, the agency failed to complete a transfer and/or discharge summary that included all pertinent information and was sent to the physician in 3 of 3 transferred/discharged records reviewed (P-6, P-7, P-10), resulting in no information regarding the goals accomplished during the course of care, and the patient's condition at discharge. Findings include: Patient #10’s (P-10) Start of Care (SOC) was dated 11/18/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure and Diabetes Type 2. During record review on 5/13/25, it was noted that the Skilled Nursing “Discharge Summary” dated 1/16/25 stated, "Discharge Date: 1/15/25. Discharged to: Hospital. Reason for Discharge: Hospitalized. Comments: Blank…Patient Status at Time of Discharge: Blank. Significant Health History: Blank…” The discharge summary failed to detail the course of care provided, responses to treatment, any potential continuing needs, reason for discharge and failed to document the patient's health status at the time of discharge. The Administrator (ADM-1) reviewed and acknowledged the findings listed about in an interview on 5/16/25 at 12:15 pm. **Agency Policy: Discharge Summary. The Policy states, "A discharge summary will be completed for all patients discharged from the agency. Purpose: To record a summary of care received by the patient from the start of care through discharge. The discharge summary will include Discharge date, reason for discharge, laboratory data, patient's discharge condition, types of services provided and frequency of services, patient's outcomes in meeting goals in the plan of care, Patient/family post-discharge instructions, goals and treatment preferences, medications at time of discharge. The discharge summary will be sent within 5 business days of patient discharge to the physician. Patient/family post-discharge instructions, goals and treatment preferences. Medications at time of discharge. A discharge summary form will be filed from each service and will be filed in the medical record. The summary will include all necessary medical information pertaining to the patient's current course of illness and treatment, including post-discharge goals of care and treatment preferences. The agency will comply with requests for additional clinical information as may be necessary for treatment made by the receiving facility or practitioner. Patient #5's (P-5): Start of Care was dated 1/31/2025. The Plan of Care for the certification period 4/1/2025 to 5/3/2025 identified diagnoses of Diabetes Type 2 with foot ulcer, non-pressure chronic ulcer of right heel and midfoot with necrosis, Encounter for surgical after care, Coronary Artery Disease, and Hypertensive heart disease with heart failure. The patient was receiving Skilled Nursing (SN) services 2 times weekly, however, there was no information found in the record that included orders for the duration of visits. This patient was discharged from the agency on 4/1/25 and transferred to a Skilled Nursing Facility. Upon review of the record, it was noted the Discharge Summary was void of Important information as follows: Nutritional Requirements: Generic. There was no information under the following Categories: Clinical Summary/Lab Data; Skin/Wound Care; Surgical Procedures; Allergies; Patient and/or Family Post-Discharge Instructions; Vital Signs; Patient Status at Time of Discharge from prior agency; Significant Health History. There was no indication or documentation that the Discharge Summary had been sent to the Physician. That area of the Discharge Summary was blank. Patient's #6's (P-6): Start of Care (SOC) was dated 3/7/2025. The Plan of Care (POC) for the certification Period 3/7/2025 to 5/5/2025 identified diagnoses of Trochanterus Bursitis of Left Hip, Alzheimer's Disease, Atrioventricular Blockage, Coronary Artery Disease, Dizziness and Giddiness. The patient was receiving Skilled Nursing, Physical Therapy, and Occupational Therapy Services. Upon review of the record, it was noted the Discharge Summary was missing pertinent information as follows: Laboratory data, Patient's discharge condition, Patient outcomes in meeting the goals in the Plan of Care, Patient and Family post-discharge instructions, current medication list, evidence that the discharge summary was sent to the primary care provider and to the nursing home facility in which the patient had been transferred. The Administrator (Adm-1) reviewed and acknowledged the findings listed above during an interview on 5/16/25 at 11:35 AM.

The following Standard level deficiencies were identified at an Emergency Preparedness survey conducted by the Michigan Department of Licensing and Regulatory Affairs on 5/16/22 through 5/19/22 at: Community Home Care Services 185 River Valley Dr. Newaygo, MI 48339 At the conclusion of the survey, this Agency was determined to be non-compliant with this Condition of Participation at a standard level.

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 Preparedness Plan existed that was based on a documented facility and community-based risk assessment from an all-hazards approach, that included identification of 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:

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), §485.625(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, 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 document review and interview, it was determined the Agency failed to provide documentation for the required Tabletop, Community/Facility based full-scale exercises nor any documentation of an actual event that would qualify as a test of the emergency plan since its initiation in 2009, resulting in the potential to affect staff and all patients currently serviced by this Agency, in the event staff is not properly prepared for an emergency. Findings include: During a review of the Agency's Emergency Preparedness documents on 5/18/22 at 12:30 p.m., it was noted that there was no evidence the Agency had conducted any drills or exercises to test the agencies Emergency plan. Further, there was no documentation of an actual event that would qualify as an emergency, no community based full-scale exercise, no second full-scale exercise or a table-top exercise. The Agency failed to provide documented evidence that the required trainings/drills had been conducted. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 5/18/22 at 12:59 p.m.

The following Condition and Standard level deficiencies were identified at a Medicare authorized Recertification Survey, concurrent with a Covid-19 Vaccine mandate protocol review, conducted by the Michigan Department of Licensing and Regulatory Affairs on 5/16/22 through 5/19/22 at: Community Home Care Services 185 River Valley Dr., Suite 103 Newaygo, MI 49337 This Agency had no additional sites. Services provided: Skilled Nursing, Physical Therapy, Occupational Therapy, Speech Therapy, Medical Social Work, Registered Dietician and Home Health Aide. Records reviewed: 5 records with home visits; 8 records without home visits for a total of 13 sampled records reviewed. The following Condition level deficiencies were identified: 42 CFR §484.60: Care Planning, Coordination, Quality of Care 42 CFR §484.70: Infection Prevention and Control 42 CFR §484.75: Skilled Professional Services As a result of the Condition level 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 observation, interview and record review, the Agency failed to ensure that 4 (MR's #3, 4, 8, and 9) of 5 patient's observed during home visits, from a total of 13 sampled records reviewed, were included in the overall planning of care including informing the patient/caregiver in advance of the days in which services would be provided, from a total of 13 sampled records reviewed, resulting in a lack of inclusion in planning, lack of informed consent, the potential missed visits and unmet care needs. Findings include: MR #: 3 The patient's start of care (SOC) was 5/5/22 with diagnoses that included Venous Insufficiency, Fractured left Femur, Ulcer lower left leg and Congestive Heart Failure. On 5/16/22 at 12:25 p.m., a joint survey home visit was conducted with the Registered Nurse (RN #1). During a review of the patient's admission packet, it was noted that the calendar that would include the patient's schedule of proposed visits to be conducted by the ordered disciplines was noted to be blank. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 5/18/22 at 1:30 p.m. MR #4: The patient's SOC was 4/22/22 with diagnoses that included Thoracic Scoliosis and Laminectomy. On 5/16/22 at 1:30 p.m., a joint survey home visit was conducted with the Occupational Therapist (OT #1). During a review of the patient's admission packet, it was noted that the calendar that would include the patient's schedule of proposed visits to be conducted by the ordered disciplines was noted to be blank. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 5/17/22 at 8:40 a.m. MR #8: The patient's SOC was 3/21/22 with diagnoses that included pneumonitis due to inhalation of food and vomit, hypertensive heart disease with heart failure, and chronic obstructive pulmonary disease (COPD). On 5/16/22 at 1:30 PM, a joint survey home visit was conducted with the Home Health Aide. During a review of the patient's admission packet, it was noted that the calendar that would include the patient's schedule of proposed visits to be conducted by the ordered disciplines was noted to be blank. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 5/19/22 at 9:30 AM. MR #9: This patient was admitted on3/3/22 with diagnoses that included COPD, hypertensive heart and chronic kidney disease with heart failure, and diabetes-type 2. On 5/16/22 at 3 PM., a joint survey home visit was conducted with the Physical Therapist (PT#1). During a review of the patient's admission packet, it was noted the calendar that would include the patient's schedule of proposed visits to be conducted by the ordered disciplines was blank concerning all Physical Therapy visits. When PT#1 was queried concerning the use of the calendar to inform the patients of scheduled visits, PT#1 replied, "That's on me, I'm terrible at filling those things out." These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 5/19/22 at 9:50 AM. The Agency failed to ensure proper utilization of the patient calendar used for the consent, and inclusion of planning/coordinating patient care visits.

Content of the comprehensive assessment CFR(s): 484.55(c) 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: This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to conduct a patient-specific, comprehensive assessment that accurately reflected the patient's current health status, past medical history, history of events leading to home care, and ascertained the patient's immediate care needs in 2 of 13 records reviewed (MR's #8, 12) out of a total of 13 records reviewed, resulting in the potential for unmet care needs for the 125 patients currently serviced by this agency. Findings included: Agency Policy: "Initial Assessments/Comprehensive Assessments 9.6.1 (Revised January 2020) stated, "Each patient admitted by the Agency will have appropriate initial assessments performed and documented...The assessment will reflect the patient's current health status and include information to demonstrate the patient's progress toward achievement of desired outcomes... Relevant medical history." MR #8: The patient's SOC was 3/21/22 with diagnoses that included pneumonitis due to inhalation of food and vomit, hypertensive heart disease with heart failure, and chronic obstructive pulmonary disease (COPD). On 5/17/22, during review of the patient's referral for home care, the following significant findings concerning the patient's current needs were noted during a physician face to face evaluation on 2/1/22: Six diagnoses dating from October 2015 (Atrial fibrillation) through 9/28/2020 (Bacterial Pneumonia). Obstructive Sleep Apnea (12/23/2015) was not controlled on BiPAP dated 7/3/21 with "significant hypoxia" with 2 liters of supplemental oxygen added to BiPAP. "Long standing history" of urinary retention was noted. Also, a recommendation for Speech Therapy for "h/o (history of) aspiration pneumonia. The initial Comprehensive Assessment performed by Skilled Nursing (SN) on 3/21/22 was reviewed and compared to the physician history noted on the referral for home care above. Multiple inaccuracies were noted, some examples include: SN documented the onset date of Atrial fibrillation 3/18/22; with 14 of the patient's listed 20 diagnoses occurring on 3/18/22 through 3/21/22 (day of admission); failed to provide any context concerning the patient's urinary retention and failed to mention any catheter utilization noted in the home care referral; failed to note the patient's need for BiPAP therapy with supplemental oxygen under the "Respiratory" section; and failed to incorporate any information concerning the physician's concerns regarding aspiration pneumonia or the need for Speech Therapy follow-up. These findings were reviewed and acknowledged by the Administrator (Adm.#1) during an interview on 5/19/22 at 0930 AM. MR#12: The Start of Care (SOC) was dated 3/25/22 with diagnoses which included transient cerebral ischemic (low oxygen) attack, urinary tract infection, and hypertension. On 5/18/22, during review of the patient's referral for home care, the following significant findings concerning the patient's current needs were noted during an emergency room physician evaluation on 3/14/22 (hospital admission 3/14 through 3/17/22). The ER physician documented the following under "History of Present Illness": "Patient was brought in by her daughter, who is at beside, and is able to provide most of the history. The patient will answer questions but has difficulty maintaining alertness. She would be awake one moment answering questions, and then would spontaneously fall asleep. Daughter states this has been happening at home more often over the last 3 weeks. The patient has had multiple falls over the course of this time... and has intermittent slurred speech. She will fall asleep in the middle of conversation and then wake up 30-40 minutes later and carry on the conversation as though she hadn't fallen asleep. When she falls asleep, she will begin drooling on herself... She continues to smoke at least one pack of cigarettes per day. She drinks alcohol daily, at least two 25 oz. beers per day. Daughter reports that 2 Saturdays ago, she found the patient in her car on the side of the road, passed out smelling heavily of alcohol and clearly inebriated. The patient suffered another fall last night while trying to walk, and daughter made the decision to bring her to the hospital today." Patient was found to be hypoxemic and placed on 2 L (liters) of oxygen. The patient was discharged to a skilled nursing facility on 3/17/25 and from there went home with home health care starting on 3/25/22. The initial Comprehensive Assessment performed by Skilled Nursing (SN) on 3/25/22 was reviewed and compared to the physician history noted on the referral for home care above. Multiple inaccuracies were noted, some examples include: SN documented the onset date(s) of all listed diagnoses (12 of 12) as being 3/17/22; failed to provide any context concerning the patient's impaired mental status with current significant use of alcohol and smoking. Further, SN noted the patient is on oxygen 2.5 L continually. No documentation was found within the comprehensive assessment concerning safety precautions or the need to educate the patient on the dangers of smoking while on oxygen, in addition to the noted alcohol abuse documented in the patient's recent history. These findings were reviewed and acknowledged by the Administrator (Adm.#1) during an interview on 5/19/22 at 0930 AM. Adm.#1 then immediately notified SN assigned to the case to make a home visit right away to inform the patient of the above concerns with documentation and post signage to the patient's front door alerting visitors of the use of oxygen with smoking. The Agency failed to ensure SN incorporated all relevant medical history to ascertain the healthcare and safety needs of the patient as stipulated by the Agency's policy above.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on document review and interview, it was determined that the Agency failed to ensure the plan of care covered all pertinent interventions with reportable parameters, safety precautions and objectively measurable goals specific to the needs of the patient for 2 (MR's #10, 12) of 13 sampled records reviewed, resulting in a poor outcome and patients not receiving care specific to their individual needs (See G574); failed to ensure the Registered Nurse promptly notified the physician in 2 (MR's #5,10) of 2 patients with elevated blood sugar values outside of the reportable parameters, from a total of 13 sampled records reviewed (See G590); and failed to coordinate care to ensure communication with patient care team members was effective for facilitating patient care needs as ordered by the physician for 1 (MR #13) of 1 record reviewed with recent multiple falls, from a total of 13 records reviewed, resulting in an increased risk for injury (See G608). Findings include: The cumulative effect of these systemic problems resulted in a poor outcome and the home health Agency's inability to ensure the provision of quality health care in a safe environment for the condition of participation of 42 CFR 484.60: Care Planning, Coordination of Services, and Quality of Care.

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 the plan of care covered all pertinent interventions with reportable parameters, safety precautions and objectively measurable goals specific to the needs of the patient for 2 (MR's #10, 12) of 13 sampled records reviewed, resulting in a poor outcome and patients not receiving care specific to their individual needs. Findings include: Policy: "Plan of Care - CMS #485 and Physician Orders" 9.10.1 (Revised March 2019) stated, "The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified... and the measurable outcomes that the Agency anticipates will occur as a result of implementing and coordinating the plan of care... must also specify the patient and caregiver education and training... Safety measures to protect against injury." MR#10: The patient was admitted on 4/29/22 with diagnoses which included diabetes-type 2 with diabetic neuropathy, intellectual disability, and wound on right lower leg. During clinical record review on 5/17/22, it was noted the Plan of Care (POC) dated 4/29/22 failed to incorporate diabetic blood sugar parameters to notify the physician. Orders for Skilled Nursing (SN) to monitor/perform blood sugar checks were not found within the POC. The POC documented, "Patient does not check blood sugar" but no refusal by the patient for SN to perform blood sugar checks was found in the clinical record. No blood sugar values were evidenced in the clinical record when the patient was admitted to the hospital on 5/6/21 through 5/12/22 due to DKA (diabetic ketoacidosis-life-threatening complication from diabetes). Review of the POC SN goals noted all (8 of 8) were found not to be objectively measurable. Examples include: "Patient /CG (caregiver) will verbalize understanding of diabetic diet as evidenced by compliance with diet plan within 5 wks. period of time; Patient/CG will verbalize understanding of diabetes type-2 and all aspects of associated care within 9 wks. period of time." These findings were reviewed and acknowledged by the Administrator (Adm.#1) during an interview on 5/19/22 at 0930 AM. Adm.#1 stated, "This will be a good teaching opportunity for our clinical staff." MR#12: The Start of Care (SOC) was dated 3/25/22 with diagnoses which included transient cerebral ischemic (low oxygen) attack, urinary tract infection, and hypertension. On 5/18/22, during review of the patient's referral for home care, the following significant findings concerning the patient's current needs were noted during an emergency room physician evaluation on 3/14/22 (hospital admission 3/14 through 3/17/22). The ER physician documented the following under "History of Present Illness": "Patient was brought in by her daughter, who is at beside, and is able to provide most of the history. The patient will answer questions but has difficulty maintaining alertness. She would be awake one moment answering questions, and then would spontaneously fall asleep. Daughter states this has been happening at home more often over the last 3 weeks. The patient has had multiple falls over the course of this time... and has intermittent slurred speech. She will fall asleep in the middle of conversation and then wake up 30-40 minutes later and carry on the conversation as though she hadn't fallen asleep. When she falls asleep, she will begin drooling on herself... She continues to smoke at least one pack of cigarettes per day. She drinks alcohol daily, at least two 25 oz. beers per day. Daughter reports that 2 Saturdays ago, she found the patient in her car on the side of the road, passed out smelling heavily of alcohol and clearly inebriated. The patient suffered another fall last night while trying to walk, and daughter made the decision to bring her to the hospital today." Patient was found to be hypoxemic and placed on 2 L (liters) of oxygen. The patient was discharged to a skilled nursing facility on 3/17/25 and from there went home with home health care starting on 3/25/22. On 5/18/22, review of the POC (dated 3/25/22) noted an order for the patient to be on oxygen at 2.5 L per minute. Further review of the POC found no evidence or acknowledgement of a specific plan to address the dangers of smoking while on oxygen, in addition to the noted alcohol abuse documented in the patient's recent history. The POC also failed to incorporate a plan/strategies/goal to address the patient's impaired mental status concurrent with significant use of alcohol/smoking/oxygen and making safe insightful decisions regarding their use. All (5 of 5) SN goals were found not to be objectively measurable, with no goals or education to the patient which addressed the concern of smoking while on oxygen. These findings were reviewed and acknowledged by the Administrator (Adm.#1) during an interview on 5/19/22 at 0930 AM. Adm.#1 then immediately notified SN assigned to the case to make a home visit right away to inform the patient of the above concerns with documentation and post signage to the patient's front door alerting visitors of the use of oxygen with smoking. The Plan of Care failed to include all the required elements and failed to meet the specific care needs of the patient as stipulated by the Agency's policy referenced above.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the Registered Nurse promptly notified the Physician of 2 (MR's #5, 10) of 2 patients who experienced an elevated blood sugar outside of the reportable parameters, from a total of 13 sampled records reviewed, resulting in the potential unidentified, untreated health conditions and unmet care needs. Findings include: Policy: "Assessment and Reassessment guidelines", 3-2018, 9.5.1 stated, "Communication: Pertinent assessment/reassessment data will be communicated to the physician..." MR #5: The patient's start of care was 3/19/22 with diagnoses that included Diabetes Mellitus (insulin dependent) and Chronic Kidney Disease. During the record review on 5/17/22 at 11:40 a.m., it was noted that the plan of car (POC) ordered the Physician to be notified if the patient's blood sugars were above 250. During the review, it was noted that on 5/3/22, the Registered Nurse documented the patient's blood sugar at 258. There was no documented evidence that the Physician had been notified as instructed in the POC. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 5/18/22 at 1:30 p.m. MR #10: The patient's start of care was 4/29/22 with diagnoses that included diabetes-type 2 with diabetic neuropathy, intellectual disability, and wound on right lower leg. On 5/17/22, review of the clinical record noted the patient was admitted to the hospital on 5/6/21 through 5/12/22 due to DKA (diabetic ketoacidosis-life-threatening complication from diabetes). Upon return to home care services on 5/14/22, the resumption plan of care orders stipulated the Physician was to be notified if the patient's blood sugars were above 300. Further review of the record noted that during a home visit on 5/21/22 by the Registered Nurse (RN), the patient's blood sugar was documented as being 356. There was no documented evidence that the Physician had been notified as instructed in the POC. During another home visit on 6/9/22, the RN documented the patient's blood sugar was 328. No evidence that the Physician had been notified was found in the clinical record. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 5/19/22 at 9:57 AM.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the Agency's skilled professional services failed to coordinate care to ensure communication with patient care team members was effective for facilitating care as ordered by the physician for 1 (MR #13) of 1 records with reviewed with recent multiple falls, resulting in unmet care needs and an increased risk for injury for this patient. Findings include: MR#13: The start of care was 12/20/21 with identified diagnoses of surgical aftercare following surgery on the circulatory system, ventricular tachycardia, and hypertension. During review of the Plan of Care (POC) on 5/17/22 prior to a scheduled joint home visit, the POC (dated 4/19/22) documented under "Safety Measures" the patient was on "Fall Precautions". The POC further instructed under SN (Skilled Nursing) orders to ensure "Home safety interventions to include: no throw rugs or secured rugs... non-slip bath mat in shower..." During the survey home visit with the LPN (Licensed Practical Nurse) on 5/17/22, the patient was observed to be using a shuffling gait without a walker upon greeting in the garage with the LPN during the home visit. The patient was found to be an extreme fall risk with impaired judgement. It was then observed the patient had 4 loose throw rugs in the garage which leads to the foyer entrance. An additional 8 loose throw rugs in the foyer entrance, living room, and kitchen were noted. Later during the visit, the bathroom tub was observed to be void of any non-slip bath mat to help prevent falls. The patient was asked how long he's had the throw rugs for and the patient responded, "Oh, for a long time now, I really don't remember." On 5/18/22, review of the clinical record noted numerous documented falls/incidents since the SOC date of 12/20/21 and they are as follow in chronological order: 1) 1/17/22, "Patient states that he was bending over trying to pick something up and he fell over, he states he landed on his back. He denies injuries..." (Physician notified) 2) 1/19/22, "Patient states that he was getting out of the passenger side of the car and slipped and fell on his back. He denies any injuries..." (Physician notified) 3) 3/14/22, "Patient also reports a near fall the other day due to increased weakness." 4) 4/5/22, "Left elbow hematoma healing. Skin color returning to normal, continues to have swelling. Bruises upper Left arm, Pt states "from a fall a couple weeks ago." 5) 4/14/22, "Patient states the cane got caught around his leg. He was in a small hallway. Seen in ED. Bruises to face, around eyes, forehead, L wrist sprain." The PT (Physical Therapy) evaluation dated 12/21/21 documented the following to be performed, "Home safety interventions to include: no throw rugs or secured rugs... non-slip bath mat in shower..." Review of the clinical record found both SN and PT had the same interventions of making the home environment more safe; the absence or at least securing all throw rugs and placing a non-slip bath mat in the shower tub. This was observed not to be done since 12/21/21, despite the numerous falls/incidents noted above. Further, no evidence was found in the LPN's visit note on 4/20/22 of notification with other team members or the physician concerning the fall on 4/14/22, which resulted in significant injury/ER visit. Additional review of the clinical record found no evidence of coordination of care efforts between SN, PT, and Agency oversight to ensure the POC interventions to help mitigate fall risk noted above were performed as ordered. The Administrator reviewed and acknowledged the findings during an interview on 5/19/22 at 10:50 AM. The Agency failed to coordinate care efforts to ensure patient safety measures were in place as stipulated in the patient's POC.

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's #3, 4) of 2 patients observed during a home visit, with a Medication Profile that included the names, dosages, frequencies, indications for use and side effects of the patient's prescribed medications, in plain language, from a total of 13 sampled records reviewed, resulting in lack of information and direction for medication administration and the potential for improper use of medications. Findings include: MR #: 3 The patient's start of care (SOC) was 5/5/22 with diagnoses that included Venous Insufficiency, Fractured left Femur, Ulcer lower left leg and Congestive Heart Failure. On 5/16/22 at 12:25 p.m., a joint survey home visit was conducted with the Registered Nurse (RN #1). During a review of the patient's admission packet, it was noted that the list of the patient's medications was void of the indication for use and any associated side effects. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 5/18/22 at 1:30 p.m. MR #4: The patient's SOC was 4/22/22 with diagnoses that included Thoracic Scoliosis and Laminectomy. On 5/16/22 at 1:30 p.m., a joint survey home visit was conducted with the Occupational Therapist (OT #1). During a review of the patient's admission packet, it was noted that the list of the patient's medications was void of the indication for use and any associated side effects. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 5/17/22 at 8:40 a.m.

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 observation, document review and interview, the Agency failed to ensure Skilled Nursing utilized Infection Control Standards of Practice during the provision of wound care observed during a home visit (MR #3) (See G 682); and failed to ensure contingency plans were in place to help mitigate the spread of COVID-19 due to unvaccinated staff (See G687). The cumulative effects of these systemic problems resulted in the agency's inability to ensure the provision of safe health care for the condition of participation of 42 CFR§484.70 Infection Prevention and Control.

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, it was determined the Registered Nurse failed to utilize Infection Control Standards of Practice during the provision of wound care for 1 (MR #3) of 1 patient observed during a home visit who received wound care services, from a total of 13 sampled records reviewed resulting the potential for the development and spread of infection, decline in wound healing and unmet care needs. Findings include: MR #3: The patient's start of care (SOC) was 5/5/22 with diagnoses that included Venous Insufficiency, Ulcer left leg. On 5/16/22 at 12:25 p.m., a scheduled home visit was conducted with the Registered Nurse (RN #1). Prior to the visit, RN #1 reported that she would be performing wound care to the patient's lower left leg. During the procedure, the following observations were made: RN #1 sanitized her hands, applied gloves and proceeded to remove the old dressing from the patient's wound. RN #1 sprayed "Integrity Wound Cleanser" on a gauze and proceeded to clean the patient's wound in a non-uniform fashion 9up and down, side to side), wiping the area from dirty to clean. RN used another gauze to wipe the wound dry, again wiping from dirty to clean. RN #1 then applied Silvadene (wound care cream) to the center of the wound and Zinc Oxide to the wound boarder. RN #1 then covered the wound with gauze and Kerlix wrap (wound dressing). RN #1 failed to utilize Infection Control standards of practice in cleansing/dressing the patient's wound from an area of dirty to clean, introducing pathogens into the wound. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 5/17/22 at 8:29 a.m.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on document review and interview, it was determined the Agency failed to ensure unvaccinated staff had implemented additional infection control measures as required, resulting in the potential for the development and spread of the COVID-19 infection for all 125 patients currently serviced by this Agency. Findings include: Agency Policy: "Staff Vaccine Policy" pg. 2 (undated) stated, "Staff who receive an exemption to the COVID-19 vaccine will be subject to additional precautions to mitigate the transmission and spread of COVID-19..." On 5/17/22 at 2:05 PM., a request was made to review the current vaccination status for all Agency staff. During review, it was noted 13 of 34 (38%) listed staff had signed religious exemptions. The Administrator (Adm.#1) was interviewed at 2:24 PM. for documentation concerning additional precautions (reassigning unvaccinated staff to non-patient areas, weekly testing, use of N95 masks...) the Agency used for the noted unvaccinated staff. Adm.#1 replied, "We haven't been requiring N95's or any weekly testing. The clinicians (unvaccinated) have been treating patients with standard masks and universal precautions, but not the extra steps you mentioned." In addition, no documentation was found where the Agency had educated staff that if they chose to remain unvaccinated, additional infection control measures noted above would ensue. At 2:28 PM., Adm.#1 acknowledged the findings and stated, "I'll go ahead and let corporate know about this right now, thank you." The Agency failed to incorporate contingency plans for unvaccinated staff as stipulated by the policy referenced above to help mitigate the spread of COVID-19.

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 observation, interview and record review, the Registered Nurse failed to utilize professional standards of practice during the patient assessment, the provision of wound care and accurate documentation for 1 (MR #3) of 2 patients observed during a home visit, from a total of 13 sampled records reviewed, resulting in the potential for care/services not meeting the individualized needs of the patient, delay in wound healing and unmet care needs (G704); failed to accurately assess the patients upon admission and throughout the course of care in 2 (MR’s #3, 5) of 2 records reviewed of patients who required ongoing monitoring of weights and edema, from a total of 13 sampled records reviewed, resulting in the potential for decline in health status, unidentified health concerns and unmet care needs (G706); the Occupational Therapist and Physical Therapist failed to conduct an accurate and complete evaluation of the patient's range of motion status in order to assist the Physician with developing a plan of care in 2 (MR's #4, 2) of 2 records of patients who required Therapy services, from a total of 13 sampled records reviewed, resulting in the potential for unidentified, unaddressed therapy needs, physical decline and unmet care needs (G708); failed to ensure Skilled Nursing services were provided as ordered for 1 (MR #6) of 1 record of a patient who required Skilled Nursing services, from a total of 13 sampled records reviewed, resulting in the potential for physiological decline, and unmet care needs (G710); failed to ensure the registered nurse supervised the care provided by the licensed practical nurse (LPN) in 2 (MR#'s 12, 13) of 8 records reviewed in which LPN services were provided, from a total of 13 sampled records reviewed (See G726); and failed to ensure the physical therapist supervised the care provided by the physical therapy assistant (PTA) in 2 of 9 records reviewed in which PTA services were provided (MR#'s 9, 13) from a total sample of 13 records reviewed (See G728). The cumulative effect of these systemic problems resulted in the Home Health Agency's inability to ensure the provision of quality health care in a safe environment for the agency's 125 current active patients for the Condition of Participation at 42 CFR 484.75: Skilled Professional Services.

Responsibilities of skilled professionals CFR(s): 484.75(b) Standard: Responsibilities of skilled professionals. Skilled professionals must assume responsibility for, but not be restricted to, the following: This STANDARD is not met as evidenced by: Based on observation, interview and record review, the Registered Nurse failed to utilize professional standards of practice during the patient assessment, the provision of wound care and accurate documentation for 1 (MR #3) of 2 patients observed during a home visit, from a total of 13 sampled records reviewed, resulting in the potential for care/services not meeting the individualized needs of the patient, delay in wound healing and unmet care needs. Findings include: MR #3: The patient's start of care (SOC) was 5/5/22 with diagnoses that included Venous Insufficiency, Ulcer left leg, Congestive Heart Failure and Diabetes Mellitus. The plan of care ordered Skilled Nursing (SN) services to be provided. On 5/16/22 at 12:25 p.m., a scheduled home visit was conducted with the Registered Nurse (RN #1). During the visit, the following observations were made: RN #1 assessed the patient's blood pressure, oxygen saturation and pulse. RN #1 did not check the patient's temperature or respiratory rate. During observation, it was noted that the patient had multiple incisions to his lateral left leg as result of a fractured femur. The largest incision to the patient's left hip was jagged and had an indentation/depth. RN #1 measured the linear length of the incision but did not measure the width or the indentation (depth). When asked of the measurements for documentation purposes, RN #1 reported, "Its (incision) 5 cm (centimeters)." RN #1 then walked to her work bag and recorded her measurements. When asked if there was a measurement of width or depth, RN #1 paused, then stated, "Its (incision width) probably about 2 cm or maybe 2 mm (millimeters)." RN #1 quoted these measurements, however did not measure the width or depth of the patient's left hip incision during the visit. RN #1 then proceeded to change the patient's lower left anterior leg dressing. The patient's wife, who was present during the visit, stated, "When you change his dressing, can you make sure you put extra gauze on it because it drains a lot." RN #1 removed the old wound dressing from the patient's leg. The dressing had a large amount of yellowish drainage on it. RN #1 proceeded to cleanse and dress the patient's wound as ordered. The clinical record was initially reviewed on 5/16/22 at 5:30 p.m. On 5/18/22 at 1:00 p.m., upon additional review, the SN visit note dated 5/16/22 (date of the home visit) was reviewed and documented: "Temperature 97.2, Respiration 16, left hip incision length 5cm, width 0.2 cm. Left lower leg incision length 5.8 cm, width of 3.2 cm and depth of 0.1 cm, drainage - small amount." RN #1 made entries in the patient's record regarding the patient's vital signs and wound status/characteristics that had not been assessed during the visit. The Registered Nurse failed to utilize professional standards of practice during the patient assessment and failed to accurately document findings as presented at the time of the visit. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 5/18/22 at 1:30 p.m. who offered no response.

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 observation, interview and record review, the Registered Nurse failed to accurately assess the patients upon admission and throughout the course of care in 2 (MR’s #3, 5) of 2 records reviewed of patients who required ongoing monitoring of weights and edema, from a total of 13 sampled records reviewed, resulting in the potential for decline in health status, unidentified health concerns and unmet care needs. Findings include: MR #3: The patient's start of care (SOC) was 5/5/22 with diagnoses that included Venous Insufficiency, Congestive Heart Failure, Fracture of left Femur and Diabetes Mellitus. The plan of care (POC) ordered Skilled Nursing (SN) 1x/wk. x 9 wks. to "Assess cardiovascular status, methods to detect/alleviate fluid, notify Physician of weight variations of +3lbs/day or + 5lbs/week, weight measurement every visit..." On 5/16/22 at 12:25 p.m. a scheduled home visit was conducted with the Registered Nurse (RN #1). During the visit, RN #1 retrieved a weight scale from her work bag, to which the patient responded, "Oh, this is something new." This writer then asked the patient if this was the first time he had been weighed, to which the patient responded, "Yes. They (Agency) haven't weighed me before." On 5/16/22 at 5:30 p.m., during the clinical record review, it was noted that the Initial Comprehensive Assessment dated 5/5/22, completed by the RN documented a weight of 298 lbs. There was no indication if this was a stated or actual weight. Additionally, there was no documented evidence that the patient's weight had been assessed upon review of the SN visit note dated 5/9/22. The RN failed to assess the patient's weight as ordered in the POC and in accordance with the patient's needs. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 5/17/22 at 8:29 a.m. MR #5: The patient's SOC was 3/19/22 with diagnoses that included Diabetes Mellitus and Hypertensive Chronic Kidney Disease. During the clinical record review on 5/17/22 at 11:40 a.m., it was noted that the POC documented: "SN Orders: EDEMA: Measure for Edema, elevate legs while siting, notify Physician of increased edema > 3 cm (centimeters); FLUID OVERLOAD: Clinician to assess/detect fluid overload, assess cardiovascular status and notify the Physician of a weight variation of 2 ponds in a day or 5 pounds in a week..." The SN visit notes revealed the following: 3/22/22 No weight (wgt.) or assessment of edema; 3/29/22 No wgt. or assessment of edema; 4/5/22 No wgt. or assessment of edema; 4/12/22 No wgt. or assessment of edema; 4/19/22 No wgt. obtained; 5/3/22 No wgt. or assessment of edema. The SN failed to assess the patient's weight and edema as ordered in the POC. These findings were reviewed with and acknowledged by Adm #1 during an interview on 5/18/22 at 1:30 p.m.

Development and evaluation of plan of care CFR(s): 484.75(b)(2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); This ELEMENT is not met as evidenced by: Based on observation, interview and record review, it was determined that the Occupational Therapist and Physical Therapist failed to conduct an accurate and complete evaluation of the patient's range of motion status in order to assist the Physician with developing a plan of care in 2 (MR's #4, 2) of 2 records of patients who required Therapy services, from a total of 13 sampled records reviewed, resulting in the potential for unidentified, unaddressed therapy needs, physical decline and unmet care needs. Findings include: MR #4: The patient's start of care (SOC) was 4/22/22 with diagnoses that included Thoracic (torso area) Scoliosis and Laminectomy (removal of portion of the vertebra/spine). The Plan of Care (POC) ordered Physical Therapy (PT) and Occupational Therapy (OT) services to be provided. On 5/16/22 at 1:30 p.m., a scheduled home visit was conducted with the Occupational therapist (OT #1). During the visit, OT #1 assessed the patient's ability to safely transfer herself to and from the shower with use of a newly installed grab bar. OT #1 also assessed the patient's positioning on the raised toilet seat using bilateral side rails/bars. These assessments required the patient's use of her upper extremities. Upon completion of the assessment, during a sit down discussion, OT #1 prepared to discharge the patient. When in a seated position, it was noted that the patient's shoulders were asymmetrical with the left shoulder being noticeably larger than the left. When instructed by OT #1 to perform upper extremity exercises, the patient was not able to elevate her left arm. OT #1 asked, "Is that new?" to which the patient replied, "No. It's been this way for a while. The Physical Therapist just noticed it it the last time he was here as well." OT # proceeded with the patient's exercises using an elastic band and continued on with the discharge process. The patient was not able to perform the exercises with her left arm. Upon completion of the visit, OT #1 was queried about his assessment of the patient's upper extremities. When asked if he had assessed the patient's upper extremity range of motion, during his Initial Evaluation, OT #1 replied, "Let me look up the evaluation I did. No. It doesn't look like I assessed her upper extremities." Upon review, the section of the OT evaluation that address range of motion was left blank. OT #1 went on to state, "I've been off for a while. Just getting back into things and I guess I just didn't assess that part." OT #1 failed to conduct a complete and accurate evaluation of the patient's health status in order to aid the Physician in the development of the OT Plan of Care. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 5/16/22 at 3:04 p.m. who reported, "He (OT #1) should assess Range of Motion on any patient he evaluates." MR #2: The patient's SOC was 11/4/21 with diagnoses that included late onset Alzheimer's Disease, Spinal Stenosis and Spinal Stenosis. The POC ordered PT services to be provided. During the record review on 5/17/22 at 9:15 a.m., it was noted that the section of the Physical Therapy evaluation dated 11/6/21 that addressed the patient's upper extremity Range of Motion was left blank. The PT failed to conduct a complete and accurate evaluation of the patient's health status in order to aid the Physician in the development of the PT Plan of Care. These findings were reviewed with and acknowledged by Adm #1 during an interview on 5/18/22 at 1:17 p.m. who reviewed the PT assessment and reported, "I can see that all areas had not been assessed. Just the lower body. He (PT) should assess the entire patient."

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, it was determined that the Agency failed to ensure Skilled Nursing services were provided as ordered for 1 (MR #6) of 1 record of a patient who required Skilled Nursing services, and failed to ensure the Skilled Nurse followed the plan of care for 1 (MR #5) 1 patient who required monitoring for fluid overload, from a total of 13 sampled records reviewed, resulting in the potential for physiological decline, and unmet care needs. Findings include: MR #6: The patient's start of care (SOC) was5/2/22 with diagnoses that included Displaced Fracture 1st Cervical Vertebrae, Diabetes Mellitus and Hypertension. During the record review on 5/17/22, it was noted that the referral for home care dated 4/27/22 ordered "Home Health Care to provide PT/OT/Nurse/Aide." (Physical Therapy/Occupational Therapy/Nurse/Aide). A "Supplemental Order" dated 5/2/22 documented, "Clarification order: No OT, HHa (Aide) per discharge instructions. No OT or HHa need identified." Skilled Nursing services had not been removed from the orders for services. At the time of this review, the patient had not received any Skilled Nursing services as ordered. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 5/18/22 at 1:48 p.m. MR #5: The patient's SOC was 3/19/22 with diagnoses that included Diabetes Mellitus and Hypertensive Chronic Kidney Disease. During the clinical record review on 5/17/22 at 11:40 a.m., it was noted that the POC documented: "SN Orders: EDEMA: Measure for Edema, elevate legs while siting, notify Physician of increased edema > 3 cm (centimeters); FLUID OVERLOAD: Clinician to assess/detect fluid overload, assess cardiovascular status and notify the Physician of a weight variation of 2 ponds in a day or 5 pounds in a week..." The SN visit notes revealed the following: 3/22/22 No weight (wgt.) or assessment of edema; 3/29/22 No wgt. or assessment of edema; 4/5/22 No wgt. or assessment of edema; 4/12/22 No wgt. or assessment of edema; 4/19/22 No wgt. obtained; 5/3/22 No wgt. or assessment of edema. The SN failed to assess the patient's weight and edema as ordered in the POC.

Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the RN (registered nurse) supervised the care provided by the LPN (licensed practical nurse) in 2 of 8 records reviewed in which LPN services were provided (MR#'s 12 and 13), from a total sample of 13 records reviewed, resulting in a lack of clinical supervision and oversight and the potential for unmet care needs. Findings include: MR#12: The Start of Care (SOC) was dated 3/25/22 with diagnoses which included transient cerebral ischemic (low oxygen) attack, urinary tract infection, and hypertension. The plan of care (POC) dated 3/25/22, ordered Skilled Nursing (SN) once weekly times 9 weeks. Review of the clinical record on 5/18/22, noted documentation of the use of a Licensed Practical Nurse (LPN) during a home visit on 4/7/22. Additional record review found no evidence in the clinical record that a RN supervised the LPN's visit. During the survey entrance conference, the Administrator (Adm.#1) was queried concerning the Agency's expectation for when the RN would supervise activities performed by the LPN. Adm.#1 replied, "Every 30 days." During an interview on 5/19/22 at 10:33 AM, Adm.#1 acknowledged the finding and stated, "We are very good at home health aide supervision, but we need to do a better job with the other services." MR#13: The patient's SOC was dated 12/20/21. The POC identified diagnoses of surgical aftercare following surgery on the circulatory system, ventricular tachycardia, and hypertension. The patient was re-certified on 2/18/22 through 4/18/22. The POC on 2/18/22 ordered a SN visit frequency once weekly times 9 weeks. Review of the clinical record on 5/18/22, noted documentation of the use of a Licensed Practical Nurse (LPN) during 8 of the 9 scheduled home visits. Additional record review found no evidence in the clinical record that a RN supervised the LPN's visits. Adm.#1 reviewed and acknowledged the findings during an interview on 5/19/22 at 10:50 AM.

Rehab services supervised by PT, OT CFR(s): 484.75(c)(2) Rehabilitative therapy services are provided under the supervision of an occupational therapist or physical therapist that meets the requirements of §484.115(f) or (h), respectively. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the PT (physical therapist) supervised the care provided by the PTA (physical therapy assistant) in 2 of 9 records reviewed in which PTA services were provided (MR#'s 9 and 13), from a total sample of 13 records reviewed, resulting in a lack of clinical supervision and oversight and the potential for unmet care needs. Findings include: MR#9: The Start of Care (SOC) was dated 3/3/22 with diagnoses which included COVID-19, chronic obstructive pulmonary disease (COPD), congestive heart failure, and diabetes-type 2. The plan of care (POC) dated 3/3/22 ordered PT services for 1W1, 2W8 (once a week times 1 week, then twice a week for 8 weeks). Review of the clinical record on 5/17/22, noted documentation of the use of a PTA during home visits made on 3/28/22 through 4/29/22 (10 of 10 visits). Additional record review found no evidence in the clinical record that a PT supervised the PTA's visits. During the survey entrance conference, the Administrator (Adm.#1) was queried concerning the Agency's expectation for when the PT would supervise activities performed by the PTA. Adm.#1 replied, "Every 30 days." During an interview on 5/19/22 at 9:45 AM, Adm.#1 acknowledged the findings and stated, "He's an excellent therapist, we'll educate and make sure we document supervisory notes better." MR#13: The patient's SOC was dated 12/20/22. The POC identified diagnoses of surgical aftercare following surgery on the circulatory system, ventricular tachycardia, and hypertension. The patient was re-certified on 2/18/22 through 4/18/22. The POC on 2/18/22 ordered a PT visit frequency of 1W9. Review of the clinical record on 5/18/22, noted documentation of the use of a PTA on 4/11/22. Additional record review found no evidence in the clinical record that a PT supervised the PTA's visit. Adm.#1 reviewed and acknowledged the finding during an interview on 5/19/22 at 10:50 AM.

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to ensure the Registered Nurse prepared clear written patient care instructions for the Home Health Aide regarding client needs, prior to providing care in 4 (MR's #5, 7, 8, 12) of 5 records in which Home Health Aide services were provided, from a total of 13 sampled records reviewed, resulting in the potential for the provision of unsafe care and unmet care needs. Findings include: Policy: "Home Health Aide Services and Training Program" 1/2020 4.12.1 stated, "Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional." MR #5: The patient's start of care was 3/19/22 with diagnoses that included Diabetes Mellitus (insulin dependent) and Chronic Kidney Disease. During the record review on 5/17/22 at 11:40 a.m., it was noted that the plan of care (POC) revealed the following: "Safety Measures: Anticoagulant (bleeding) precautions, support during transfer/ambulation, Fall Precautions, Covid, Diabetic precautions; Equipment: Elevated toilet seat, Grab bars, tub/Shower bench, Walker; Functional Limitations: Bowel/Bladder (incontinence), Hearing, Endurance..." The "Home Care Aide" plan of care, undated, was void of all the above mentioned safety measures, equipment and information on the patient's limitations. Additionally, the Aide Care Plan did no t provide instruction on the frequency of visits, or the frequency in which tasks were to be performed. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 5/18/22 at 1:30 p.m. MR #7: The patient's SOC was 4/29/22 with diagnoses that included Heart Attack, Ischemic Cardiomyopathy and End Stage Renal Disease. During the record review on 5/17/22, it was noted that the POC ordered Home Health Aide services to be provided and listed the following: "Safety Measures: Bleeding precautions, Oxygen precautions, support during transfer/ambulation, Fall precautions, Covid-19, DM; Equipment: Elevated toilet seat Grab bars, Tub/Shower bench, Walker, Colostomy, Catheter..." The "Home Care Aide" plan of care, undated, was void of all the above mentioned safety measures and equipment. Additionally, the Aide Care Plan did no t provide instruction on the frequency of visits, or the frequency in which tasks were to be performed. These finding were reviewed with and acknowledged by Adm #1 during an interview on 5/18/22 at 1:55 p.m. MR #8: The patient's start of care (SOC) was 3/21/22 with diagnoses that included pneumonitis due to inhalation of food and vomit, hypertensive heart disease with heart failure, and chronic obstructive pulmonary disease (COPD). During the record review on 5/17/22, it was noted that the plan of care (POC) revealed the following: "Safety Measures: Anticoagulant (bleeding) precautions, Slow position change, Proper position during meals, Support during transfer/ambulation, Fall Precautions, Covid; Equipment: Elevated toilet seat, Grab bars, Tub/Shower bench, Walker; Straight catheter supplies." In addition, the POC ordered Home Health Aide (HHa) services at a frequency of 2x/wk. x 8 wks. The "Home Care Aide" plan of care, undated, was void of all the above mentioned safety measures, equipment and information on the patient's limitations. Further, the Aide Care Plan did not provide instruction on the frequency of visits, or the frequency in which tasks were to be performed. These findings were reviewed with and acknowledged by the Administrator (Adm.#1) during an interview on 5/19/22 at 09:30 AM. MR #12: The SOC was dated 3/25/22 with diagnoses which included transient cerebral ischemic (low oxygen) attack, urinary tract infection, and hypertension. During the record review on 5/18/22, it was noted that the POC ordered HHa services to be provided at a frequency of 1x/wk. x 9 wks., and listed under "Safety measures" the following: "Anticoagulant precautions, Oxygen precautions, Use of assistive devices, Support during transfer/ambulation, Fall precautions, Covid-19; Equipment: Walker." The "Home Care Aide" plan of care, undated, was void of all the above mentioned safety measures and equipment. Additionally, the Aide Care Plan failed to provide instruction on the frequency of visits, or the frequency in which tasks were to be performed. These findings were reviewed with and acknowledged by Adm #1 during an interview on 5/19/22 at 10:33 AM.

Administrator appointed by governing body CFR(s): 484.105(b)(1)(i) (i) Be appointed by and report to the governing body; This ELEMENT is not met as evidenced by: Based on interview, the Agency failed to ensure the Administrator was appointed by, and reported to the Governing Body resulting in the potential for lack of oversight of the Agency's functions and unmet patient care needs. Findings include: On 5/18/22, during a review of the Agency's Governing Board meeting minutes, the Administrator (Adm #1) was asked for permission to review the letter of delegation that showed she had been appointed Administrator by the Governing Board yet was unable to do so. The Agency failed to provide documented evidence that the Administrator had been appointed by and reported to the Governing Body.

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 record review and 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 5/16/22 during the Entrance Conference, the Administrator (Adm #1) was queried as to whether the Agency had an Alternate Administrator or a qualified alternate to act on the Administrator's behalf in her absence and reported the name of an individual who would act as alternate. On 5/18/22 at12:47 p.m., the Governing Board meeting minutes were reviewed with Adm #1. When asked for documented evidence that the identified alternate Administrator had been approved by the Governing Board members, Adm #1 was unable to provide any evidence of the Governing Board's approval. 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 insure a detailed discharge summary had been completed and sent to the physician within 5 business days of discharge for 2 (MR's #1, 2) of 4 records where the patient was discharged from Agency services, resulting in a lack of information to ensure continuity of care and the potential for unmet care needs. Findings include: Policy: "Discharge Summary" stated, "A Discharge Summary will be completed for al patients discharged from the Agency..., to record a summary of care received by the patient from the start of care through discharge..." MR 1: The patient's start of care (SOC) was 9/15/21 with diagnoses that included Knee Replacement and Diabetes Mellitus. The plan of care (POC) ordered Skilled Nursing (SN) at a frequency of 1x/wk. x 3 wks., 1x/month x 2/months, and Physical Therapy (PT) services to be provided 1x/wk. x 1 wk., 2x/wk. x 8 wks. During the clinical record review on 5/16/22, it was noted SN discharged the patient on 10/20/21. At the time of this record review, no SN discharge Summary had been completed and forwarded to the Physician. Further, the patient was discharged from PT services on 10/28/21. Upon review, there was no documented summary that detailed the course of care, services provided with responses to treatment. These findings were reviewed with and acknowledged by the Administrator during an interview on 5/17/22 at 8:20 a.m. MR #2: The patient's SOC was 11/4/21 with diagnoses that included Late onset Alzheimer's disease, Unsteady Gait and Spinal Stenosis. The POC ordered SN and PT services to be provided. During the record review on 5/17/22 at 9:15 a.m., it was noted that the patient was discharged from SN services on 11/19/21. At the time of this review, no SN Discharge Summary had been completed and forwarded to the Physician as per this requirement. Additionally, the patient was discharged from PT services on 12/18/21. Upon review of the PT Discharge Summary dated 12/18/21, there was no documented summary that detailed the course of care, services provided with responses to treatment. These findings were reviewed with and acknowledged by Adm #1 during an interview on 5/18/22 at 1:17 p.m.