Every finding on record at Reliable Home Health Patient Care Co

A Medicare recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs on 5/27/25 through 5/30/25 at: Reliable Home Health Patient Care Co 29226 Orchard Lake Rd., Suite 210 Farmington Hills, MI 48334 At the conclusion of the survey, Reliable Home Health Patient Care Co was found not in compliance with the requirements for participation in Medicare at 42 CFR 484.102, Emergency Preparedness.

Development of EP Policies and Procedures CFR(s): 484.102(b) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to develop and update Emergency Preparedness (EP) policies and procedures that were based on an agreed upon all-hazards risk assessment, resulting in the Agency's inability to implement appropriate emergency actions which could negatively affect the health and safety of all patients serviced by the Agency. Findings include: The Agency's Emergency Preparedness (EP) binder was reviewed on 5/28/25. During review, it was noted that 7 different versions of the all-hazards risk assessments were being utilized. Seven staff members each filled out a separate all-hazards risk assessment and no two were identical. For example, a basic hazard such as water/flooding were identified as a high risk on one risk assessment and a low risk on another. Subsequently, the Agency did not have an agreed upon response for various emergency situations, potentially putting the patient's and staff safety at risk. The Administrator (Adm-1) reviewed and acknowledged the above findings during an interview on 5/28/24 at 3:10 PM. Adm-1 noted that only one master all-hazards risk assessment would be used going forward.

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined that the home health agency (HHA) failed to document initial training in emergency preparedness policies and procedures for 7 of 8 (PT-1, PT-2, PT-3, RN-1, RN-2, HHa-1, DON-1) employee records reviewed, including contract employees, and failed to maintain documentation of training for 7 of 8 (PT-1, PT-2, PT-3, RN-1, RN-2, HHa-1, DON-1) employees, resulting in the potential for inappropriate, unprepared responses to emergencies and interruption in the provision of needed patient care and services. Findings include: During review of employee records on 5/30/25, it was discovered that 7 of 8 (PT-1, PT-2, PT-3, RN-1, RN-2, HHa-1, DON-1) employee files reviewed had no documented evidence of initial or ongoing Emergency Preparedness training. There was no indication that initial Emergency Preparedness training had been provided to all 8 staff records reviewed, including contracted staff, as required, and no staff attendance sheet was available. The agency failed to document initial training in Emergency Preparedness policies and procedures to all new and existing staff, including contract employees, and failed to maintain documentation of training. During an interview on 5/30/25 at 1:35 p.m., the administrator (ADM-1) and the Director of Nursing (DON-1) acknowledged the above findings.

A Medicare recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs from 5/27/25 through 5/30/25 at: Reliable Home Health Patient Care Co. 29226 Orchard Lake Rd., Suite 210 Farmington Hills, MI 48334 This Agency has no branch sites. For this survey, 3 records with home visits, 2 active records, and 2 discharge records were reviewed, for a total of 7 records reviewed. The following Condition Level deficiencies were identified: 42 CFR §484.60: Care Planning, Coordination, Quality of Care 42 CFR §484.65: Quality Assessment and Performance Improvement (QAPI) 42 CFR §484.80: Home Health Aide Services At the conclusion of the survey, it was determined that the Agency was out of compliance at the condition level for the conditions of participation at 42 CFR Part 484, requirements for Home Health Agencies. 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).

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: (1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the comprehensive assessment accurately reflected the patient's current health status for 1 (Patient/P-1) of 7 records reviewed, resulting in incomplete clinical information to aid in determining the needs of this patient and for measuring the patient's progress toward goals/outcomes. Findings include: This patient (P-1) was admitted to the home care Agency on 5/13/24, with diagnoses that included pressure ulcer (Stage-2) of sacral region, hemiplegia affecting left side of the body, COPD (chronic obstructive pulmonary disease), use of supplemental oxygen, and hypertension. On 5/28/25, review of the referral for home care noted P-1 was admitted to the hospital on 5/4/24 for worsening COPD symptoms and discharged on 5/10/25. The physician referral documented the following pertinent clinical findings: "Patient is a 67-year-old paraplegic male with multiple recent admissions to (hospital)... severe COPD on 3 L (liters) of O2 (oxygen)." Documentation also noted P-1 had a blood oxygen level of 85% on 3 L of oxygen and a CT scan revealed possible lung aspiration. History noted paraplegia due to mechanical fall in 2019, and supplemental oxygen use while being a current smoker. Further review of P-1's initial comprehensive assessment (ICA) performed by Skilled Nursing (SN), noted no detailed history of oxygen saturation levels with or without activity despite significant history requiring hospitalization. No oxygen precautions were mentioned in the ICA and SN marked "No safety risks noted" despite P-1 still using oxygen while smoking. No evidence was found within the assessment which acknowledged recent hospitalizations or the events that led up to admission to the home care Agency. The Administrator reviewed and acknowledged the above findings during an interview on 5/30/25 at 12:20 PM.

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 patient's medication reconciliation was updated and revised within 48 hours of the patient's return to home following hospitalization for 1 (Patient/P-1) of 1 record reviewed with a ROC (resumption of care) visit post-hospitalization, out of a total sample of 7 records reviewed, resulting in unaccounted new medications with no review for potential severe drug to drug interactions and poor clinical outcomes. Findings include: This patient (P-1) was admitted to the home care Agency on 5/13/24, with diagnoses that included pressure ulcer (Stage-2) of sacral region, hemiplegia affecting left side of the body, COPD (chronic obstructive pulmonary disease), use of supplemental oxygen, and hypertension. On 5/28/25, record review revealed P-1 was transferred to the hospital for pneumonia on 5/18/24 and discharged on 6/5/24. Review of hospital discharge records noted under "Your Home Medication List" the following new medications: Prednisolone (anti-inflammatory) 4 mg., Breo-Ellipta (helps lesson COPD symptoms) 100 mcg-25 mcg., Lasix (diuretic) dosage change of 20 mg. to 40 mg., Atorvastatin (lowers cholesterol 40mg. to 10mg., DuoNeb (respiratory treatment) 0.5-2.5 mg/3 ml., Thiamine (B-1 vitamin) 100 mg., Magnesium hydroxide (treat constipation symptoms) 8% oral suspension, and Neurontin (treats nerve pain) 300 mg. None of these medications prescribed by the physician during hospitalization and to be continued at home were evidenced in P-1's medical record. The Administrator reviewed and acknowledged the above findings during an interview on 5/30/25 at 12:30 PM. The Agency failed to ensure the comprehensive assessment was updated and revised within 48 hours of the patient's return home post discharge from the hospital.

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 (POC) included objectively measurable and individualized goals in 1 (Patient/P-1) of 5 records reviewed with Skilled Nursing (SN) ordered out of a total sample of 7 records reviewed; failed to include all pertinent safety precautions in 1 (P-1) of 7 records reviewed; and failed to incorporate safety parameters concerning blood oxygen levels (See G 574); failed to ensure that treatment/interventions were provided only in accordance with physician's orders for 1 (P-1) of 7 records reviewed (See G 580); failed to ensure the physician was promptly notified of signs and symptoms of fluid overload in 1 (P-1) of 1 record reviewed with SCIC (significant change in condition) out of 7 records reviewed (See G 590), and failed to ensure the revised Plan of Care reflected the current information from the updated comprehensive assessment in 1 (P-1) of 1 record reviewed with a ROC (resumption of care) post-hospitalization out of a total of 7 records reviewed (See G 592). The cumulative effect of these systemic problems resulted in the Agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.60 Care Planning, Coordination, 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 failed to include safety precautions, safety parameters concerning blood oxygen levels, and objectively measurable goals specific to the individualized needs of the patient in 5 (P-1, 4, 5, 6, 7) records, from a total of 7 sampled records reviewed, resulting in the potential for poor patient outcomes and unmet care needs. Findings include: Patient #4's (P-4) start of care (SOC) was 4/5/25, with diagnoses of arrythmia, tachycardia, heart failure, and diabetes. The plan of care (POC) dated 4/5/25, had skilled nursing ordered for 1 visit a week for 3 weeks, and physical therapy ordered for 2 visits a week for 6 weeks then 1 visit a week for 1 week. During record review on 5/30/25, it was discovered that the goals on the POC were not measurable. One goal stated, "Patient will attain optimal effectiveness of paint management regimen by 3 weeks. Another stated, "Patient/Caregiver demonstrate ability to effectively manage medication regimen by 2 weeks." There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. Patient #5's (P-5) SOC was 5/15/25, with diagnoses of hypertension, pain, and sciatica. The POC dated 5/15/25, had skilled nursing ordered for 1 visit a week for 3 weeks, and physical therapy ordered for 1 visit a week for 1 week, then 2 visits a week for 6 weeks. During record review on 5/30/25, it was discovered that the goals on the POC were not measurable. One goal stated, "Patient/Caregiver will demonstrate competence with self-management of chronic obstructive pulmonary disease (COPD) as evidenced by adherence to medication regimen, ability to identify signs and symptoms necessitating contact with medical professionals, diet regimen guidelines, activity compliance, and symptom management by 3 weeks. Another stated, "Patient will demonstrate compliance with medication regimen as evidenced by correct administration, reporting side effects or adverse reactions by 3 weeks." There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. Patient #6's (P-6) SOC was 4/22/25, with diagnoses of COPD, radiculopathy, and myocardial infarction. The POC dated 4/22/25, had skilled nursing ordered for 1 visit a week for 4 weeks, and physical therapy ordered for 1 visit a week for 1 week, 2 visits a week for 6 weeks, and 1 visit a week for 1 week. During record review on 5/29/25, it was discovered that the goals on the POC were not measurable. One goal stated, "Patient/Caregiver will demonstrate competence with self-management of chronic obstructive pulmonary disease (COPD) as evidenced by adherence to medication regimen, ability to identify signs and symptoms necessitating contact with medical professionals, diet regimen guidelines, activity compliance, and symptom management by 3 weeks. Another stated, "Patient/Caregiver demonstrate ability to effectively manage medication regimen by 3 weeks." There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. The POC for P-6 also failed to document anticoagulant/bleeding precautions with an order for Eliquis (Anticoagulant). Patient #7's (P-7) SOC was 2/1/24, with diagnoses of COPD, shortness of breath, hypertension and diabetes. The POC dated 2/1/24, had skilled nursing ordered for 1 visit a week for 5 weeks, and physical therapy ordered for 1 visit a week for 1 week, 2 visits a week for 6 weeks, and 1 visit a week for 1 week. During record review on 5/28/25, it was discovered that the goals on the POC were not measurable. One goal stated, "Patient will demonstrate steps to protect oneself and others from COVID-19 infection throughout certification period. Another stated, "Patient's activity level will improve due to effective pain control within 4 weeks." There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. During an interview on 5/30/25 at 1:35 p.m., the Administrator (ADM-1) and the Director of Nursing (DON-1) acknowledged the above findings. This patient's (P-1) start of care to the home care Agency was on 5/13/24, with diagnoses that included pressure ulcer (Stage-2) of sacral region, hemiplegia affecting left side of the body, COPD (chronic obstructive pulmonary disease), use of supplemental oxygen, and hypertension. The Plan of Care (POC) dated 5/13/24, ordered skilled nursing (SN) visits twice weekly times 8 weeks and physical therapy to evaluate and treat. On 5/29/25, record review noted the POC failed to include oxygen safety precautions despite documentation in the physician referral for home care that showed P-1 is an active smoker. In addition, P-1 has a significant history for respiratory issues that required multiple hospitalizations within the last 2 years and supplemental oxygen needs. The POC had no blood oxygen level safety parameters in which to notify the physician if P-1 experienced any shortness in breath or difficulty in breathing. Further record review noted that 4 of 4 SN goals on the POC were not measurable. Examples include: "Patient will have promotion of healing and restoration of skin integrity without complications by/within time-period; Patient/Caregiver will demonstrate ability to effectively manage medication regimen by/within time-period." There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. The Administrator reviewed and acknowledged the above findings during an interview on 5/30/25 at 12:35 PM.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure services were provided only as ordered by the physician in 1 (Patient/P-1) of a total sample of 7 records reviewed, resulting in the potential to negatively affect all 11 patients currently serviced by the Agency. Findings include: This patient (P-1) was admitted to the home care Agency on 5/13/24, with diagnoses that included pressure ulcer (Stage-2) of sacral region, hemiplegia affecting left side of the body, COPD (chronic obstructive pulmonary disease), use of supplemental oxygen, and hypertension. The Plan of Care (POC) dated 5/13/25, ordered skilled nursing (SN) visits twice weekly times 8 weeks and physical therapy to evaluate and treat. On 5/29/25, record review noted the POC ordered the following: "SN (Skilled Nursing) to perform wound care as follows: SACRAL: Cleanse wound with wound cleanser applied collagen dressing, covered with mepilex border." (sic) Further record review found SN/LPN-1 provided wound care treatment on 6/8/24 and again on 6/12/24. LPN-1 documented on the 6/8/24 visit under "Treatments Performed" the following: "Dry skin areas cleansed wound with noormal saline applied Tetracyte 3% and petroleum gauze 2x2 dressing cleaned buttocks, dru, pink and intact skin with normal saline, pat dry, applied meta honey protroleum gauze and covered with 3x5 gauze secured with tape." (sic) LPN-1 documented on the 6/12/24 visit under "Treatments Performed" the following: "Dry skin areas cleansed wound with noormal saline applied Tetracyte 3% and petroleum gauze 2x2 dressing cleaned buttocks, dru, pink and intact skin with normal saline, pat dry, applied meta honey protroleum gauze and covered with 3x5 gauze secured with tape." (sic) The Administrator (Adm-1) reviewed and acknowledged the above findings during an interview on 5/30/25 at 12:40 PM. Adm-1 was then queried if the medical record had any orders which authorized LPN-1 to perform wound as documented above. Adm-1 stated, "I don't see an order in our records." Adm-1 noted that LPN-1 no longer works with the Agency since last summer.

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 physician was promptly notified of an SCIC (significant change in condition) for 1 (Patient/P-1) of 7 records reviewed, resulting in the potential to negatively affect the health and well-being of this patient. Findings include: This patient (P-1) was admitted to the home care Agency on 5/13/24, with diagnoses that included pressure ulcer (Stage-2) of sacral region, hemiplegia affecting left side of the body, COPD (chronic obstructive pulmonary disease), use of supplemental oxygen, and hypertension. On 5/29/25, record review revealed P-1 was transferred to the hospital for pneumonia on 5/18/24 and discharged on 6/5/24. Review of hospital discharge records noted the need for P-1 to be weighed daily and to "report weight gain more than 2 pounds in a 24-hour period or 5 pounds within a week... increased swelling in your ankles, legs or stomach/abdomen." P-1 had a ROC (resumption of care) visit performed on 6/6/24 by Skilled Nursing (SN), who is also the Agency's DON (Director of Nursing). Record review from admission through 6/6/24 noted no edema (swelling) of any kind concerning P-1. However, a visit performed by SN (LPN-1) on 6/8/24 documented the following under "Visit Narrative": "Complains of shortness in breath (SOB) at rest... +3 pitting edema (swelling) BLE (bilateral lower extremities)." This represented a significant change from the ROC visit on 6/6/24 (no edema) to +3 (+4 being highest level possible) within 48 hours. This finding (+3 edema BLE and SOB) was again found on the next SN visit on 6/12/24. LPN-1 failed to notify the physician or the Agency's DON concerning the increased swelling for both visits noted above. Further review revealed the last medical record entry was performed by SN on 6/14/24 "Death at Home". Findings which would explain cause of death were not found in P-1's medical record. Additional efforts were made to the Wayne county's coroner's office which was contacted at on 5/29/25 at 12:44 PM. to ascertain cause of death. The office noted P-1's death was on file but did not include cause of death. SOM (State of Michigan) vital records stated a report could be purchased once proper forms had been filled out, usually taking a couple of weeks. These findings were reviewed with and acknowledged by the Administrator (Adm-1) during an interview on 5/30/251 at 12:40 PM. Adm-1 noted LPN-1 is no longer working with the Agency since last summer.

Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient's updated comprehensive assessment, and contain information concerning the patient's progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to ensure that the Plan of Care (POC) was updated to reflect the current information from the updated comprehensive assessment in 1 (Patient/P-1) of 1 record reviewed with a ROC (resumption of care) visit post-hospitalization, out of a total sample of 7 records reviewed, resulting in a POC that does not meet the patient's current clinical needs and the potential for unrecognized lack of progress towards patient centered goals. Findings include: This patient (P-1) was admitted to the home care Agency on 5/13/24, with diagnoses that included pressure ulcer (Stage-2) of sacral region, hemiplegia affecting left side of the body, COPD (chronic obstructive pulmonary disease), use of supplemental oxygen, and hypertension. On 5/29/25, record review revealed P-1 was transferred to the hospital for pneumonia on 5/18/24 and discharged on 6/5/24. Review of hospital discharge records noted the need for P-1 to be weighed daily and to "report weight gain more than 2 pounds in a 24-hour period or 5 pounds within a week... increased swelling in your ankles, legs or stomach/abdomen." On 6/6/24, a ROC (resumption of care) visit was performed by Skilled Nursing (SN), who is also the Agency's DON (Director of Nursing). Record review from admission through 6/6/24 noted no edema (swelling) of any kind concerning P-1. However, a visit performed by SN (LPN-1) on 6/8/24 documented the following under "Visit Narrative": "Complains of shortness in breath (SOB) at rest... +3 pitting edema (swelling) to BLE (bilateral lower extremities)." This represented a significant change from the ROC visit on 6/6/24 (no edema) to a severe +3 (+4 being extreme/highest level possible) within 48 hours. This finding (+3 edema BLE and SOB) was again documented by LPN-1 during the next SN visit on 6/12/24. LPN-1 failed to notify the physician or the Agency's DON concerning the increased swelling for both visits noted above. Further review noted the last medical record entry was performed by SN/DON on 6/14/24 "Death at Home". Findings which would explain cause of death were not found in P-1's medical record. Additional efforts were made to the Wayne county's coroner's office which was contacted at on 5/29/25 at 12:44 PM. to ascertain cause of death. The office noted P-1's death was on file but did not include cause of death. SOM (State of Michigan) vital records stated a report could be purchased once proper forms had been filled out, usually taking a couple of weeks to complete. The Administrator (Adm-1) reviewed and acknowledged the above findings during an interview on 5/30/24 at 12:45 PM. Adm-1 noted LPN-1 is no longer working with the Agency since last summer.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on interview and record review, it was determined the Agency failed to provide evidence of its efforts to measure, track and analyze it's quality indicators and show measurable improvement in patient care and services (See G 642); failed to develop Performance Improvement activities, as part of the Agency's Quality Assessment Performance Improvement program, in order to track and trend adverse patient events, analyze the cause and implement preventive interventions (See G 654); failed to document any of the required annual quality improvement projects since 2023 through 5/27/25, including the reasoning for conducting these projects and the measurable progress achieved each year (See G 658); and failed to ensure the Agency had an active and functioning Quality Assessment and Performance Improvement program that addressed priorities for improved quality of care and patient safety which evaluated its effectiveness (See G660). The cumulative effect of these systemic problems resulted in the Agency's inability to ensure the provision of quality health care for all patients the Home Health Agency has serviced for the condition of participation of 42 CFR§484.65 Quality Assessment and Performance Improvement (QAPI).

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to develop, implement, and maintain a Quality Assessment and Performance Improvement (QAPI) program which provided documentation of its efforts to measure, track and analyze quality indicators that represented pre-established performance improvement projects (PIP's) designed to optimize patient care services, and failed to have measures in place to recognize the highest level of a poor outcome (death), resulting in the inability to determine the quality of services provided and the potential unmet care needs for all 11 active patients currently being served by this Agency. Findings include: On 5/29/25, the Agency's QAPI documentation was reviewed which revealed a failure to document efforts to systematically collect data, monitor, analyze and improve patient outcomes based off the Governing Body approved PIP's. Review of the QAPI binder since 2022 noted 3 annual QAPI meetings (last being 10/18/24). Each of the QAPI meetings concerning its QAPI program were entirely based off a half page of autogenerated data from iQIES "Outcome Reports" which focused on aide services, management of oral medications and patient falls with injury. The Agency was in line for aide services and falls and below national averages concerning management of oral medications (85.6% in 2024 compared to 96.5% National and 84.5% in 2023 vs. 96.5% National). No evidence was found in the QAPI program of any efforts made by the Agency to develop its QAPI program to identify areas of improvement. The lone area identified regarding oral medications above had no follow-up activities or evidence it was addressed in any manner. An area of concern was also identified during the survey on 5/29/25, patient record (P-1) who died at home after a SCIC (significant change in condition) was documented by skilled nursing services regarding potential fluid overload. The Agency failed to have any measures in place to capture this sentinel event which went unnoticed by the Agency since 6/14/24. No effort was made by the Agency to determine if the SCIC potentially contributed to P-1's death. The Administrator and Director of Nursing reviewed and acknowledged the findings above during an interview on 5/29/25 at 4:10 PM. The Agency failed to adhere to its policy referenced below. Agency Policy: "Quality Assessment and Performance Improvement (QAPI)" (undated) stated on pg. 1 the following: "The Agency has established an ongoing program of quality assessment and performance improvement. To collect and analyze data to improve identified processes of patient care/services as well as outcomes of patient care... To establish mechanisms to reprioritize QAPI activities in response to unusual and/or urgent events. To allocate adequate resources for QAPI."

Track adverse patient events CFR(s): 484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to develop performance improvement activities, as part of the Agency's Quality Assessment Performance Improvement (QAPI) program, to track and trend adverse patient events, analyze the cause and implement preventive interventions, resulting in the potential for the rendering of substandard care and unmet care needs for all 11 patients currently receiving services. On 5/29/25, during review of the Agency's QAPI documents since 2022, it was noted there was no evidence that the Agency had attempted to implement any quality improvement measures or activities that would serve to track/trend adverse patient events, analyze causative factors and implement preventive interventions. Further, an area of concern was identified during the survey on 5/29/25, regarding an adverse event for patient record (P-1) who died at home after a SCIC (significant change in condition) was documented by skilled nursing services regarding potential fluid overload. The Agency failed to have any quality performance activities in place to capture this sentinel event which went unnoticed by the Agency since 6/14/24. The Administrator and Director of Nursing reviewed and acknowledged the findings above during an interview on 5/29/25 at 4:20 PM. The Agency failed to adhere to its policy referenced below. Agency Policy: "Quality Assessment and Performance Improvement (QAPI)" (undated) stated on pg. 1 the following: "The Agency has established an ongoing program of quality assessment and performance improvement. To establish mechanisms to reprioritize QAPI activities in response to unusual and/or urgent events. To allocate adequate resources for QAPI."

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to develop a Performance Improvement Project (PIP) within its QAPI (Quality Assessment Performance Improvement) program, resulting in the Agency's inability to effectively monitor proposed improvements in patient care, health outcomes, patient safety, quality of care and overall performance for all patients. Findings include: On 5/29/25, the Agency's QAPI documentation was reviewed since 2022, and found no evidence of a PIP that was chosen and approved to gather information to track and tread towards pre-established goals for quality improvement for the last 3 years. The Administrator and Director of Nursing reviewed and acknowledged the findings above during an interview on 5/29/25 at 4:25 PM. The Agency failed to adhere to its policy referenced below. Agency Policy: "Quality Assessment and Performance Improvement (QAPI)" (undated) stated on pg. 1 the following: "The Agency has established an ongoing program of quality assessment and performance improvement. To create and maintain information systems (manual and/or computer) to support the collecting, managing and analyzing of data needed to facilitate ongoing QAPI." The Agency's QAPI policy failed to contain language that directly acknowledged and detailed the utilization of PIP's.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the Governing Body failed to ensure the Agency had an active and functioning Quality Assessment and Performance Improvement (QAPI) program that addressed priorities for improved quality of care, maintained patient safety standards, and was evaluated for its effectiveness, resulting in the potential to adversely affect the quality of care to all 11 patients currently receiving services and all 67 patients admitted over the past year. Findings include: On 5/29/25, the Agency's QAPI documentation was reviewed and revealed a failure to document efforts to systematically collect data, monitor, analyze and improve patient outcomes based off the Governing Body (GB) meeting minutes. Review of the QAPI binder since 2022 noted 3 annual QAPI meetings (last being 10/18/24). Each of the QAPI meetings concerning its QAPI program were entirely based off a half page of autogenerated data from iQIES "Outcome Reports" which focused on aide services, management of oral medications and patient falls with injury. The Agency was in line for aide services and falls but below national averages concerning management of oral medications (85.6% in 2024 compared to 96.5% National and 84.5% in 2023 vs. 96.5% National). No evidence was found that the GB made any efforts to develop its QAPI program to identify areas of improvement. One area that could be improved from the Outcome Reports was oral medications noted above, but the GB failed to recognize this opportunity for the last two years. An area of concern was also identified during the survey on 5/29/25, patient record (P-1) who died at home after a SCIC (significant change in condition) was documented by skilled nursing services regarding potential fluid overload. The GB failed to have any measures in place to capture this sentinel event which went unnoticed by the Agency since 6/14/24. No effort was made by the GB to determine if the SCIC potentially contributed to P-1's death. The Administrator and Director of Nursing reviewed and acknowledged the findings above during an interview on 5/29/25 at 4:15 PM. The Agency failed to adhere to its policy referenced below. Agency Policy: "Quality Assessment and Performance Improvement (QAPI)" (undated) stated on pg. 1 the following: "The Governing Body is ultimately responsible for QAPI and implementation of the QAPI plan."

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases as a part of the Agency's QAPI (Quality Assessment Performance Improvement) program, resulting in the potential spread of infections between patient care staff and the Agency's 67 patients admitted in the past year. Findings include: On 5/29/25, the Agency's QAPI program concerning infection control was reviewed. Since 2023, documentation of infection control data with coordinated analysis, discussions with resultant actions for improvement were not found during the recertification survey. The Agency did provide documentation of patient infections with their associated outcomes. However, the Agency failed to produce any evidence which utilized collected data for analysis. The patient infection data collected was never tracked and trended towards pre-established goals focusing on improving infection control. The Administrator and Director of Nursing reviewed and acknowledged the findings above during an interview on 5/29/25 at 4:15 PM.

Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This STANDARD is not met as evidenced by: Based on record review, and interview, it was determined the Home Health Agency failed to provide documented evidence that infection control education was provided to 2 of 8 employee records (PT-1, PT-3) reviewed, including contracted staff, employed by the agency and who were granted clinical privileges, resulting in the potential for the development and spread of infection to all patients. Findings include: On 5/30/25, during review of 8 clinical employee records, it was noted that infection control in-service education was not documented for 2 of 8 employees (PT-1, PT-3), and 2 of the 8 employees (RN-1, PT-2) had no infection control education since 2023. The agency failed to provide the required infection control education and in-services to all staff, including contracted staff. During an interview on 5/30/25 at 1:35 p.m., the administrator (ADM-1) and the Director of Nursing (DON-1) acknowledged the above findings.

Participate in HHA-sponsored in-service CFR(s): 484.75(b)(9) Participation in HHA-sponsored in-service training. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure 1 of 1 contracted home health aides (HHa-1) participated in agency sponsored in-services, resulting in the potential for poor patient outcomes. Findings include: During record review on 5/30/25, it was discovered that HHa-1's record failed to document any in-services for any year of employment since their hire date of 3/25/2018. During an interview on 5/30/25 at 1:35 p.m., the administrator (ADM-1) and the Director of Nursing (DON-1) acknowledged the above findings and ADM-1 stated, "HHA-1 is contracted, we do not in-service them, their staffing agency takes care of that."

Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure 1 of 1 home health aides (HHA-1) had the required in-services documented in the record, see (G-774); and failed to ensure a yearly on-site home health aide supervisory visit for HHA-1 was documented in the record, see (G-812). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care in a safe environment, which could result in the agency not providing quality health care.

12 hours inservice every 12 months CFR(s): 484.80(d) Standard: In-service training. A home health aide must receive at least l2 hours of in-service training during each 12-month period. In-service training may occur while an aide is furnishing care to a patient. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure 1 of 1 home health aides (HHa-1) received at least 12 hours of in-services each year, resulting in the potential for un-met care needs and poor patient outcomes. Findings include: During record review on 5/30/25, it was discovered that HHa-1's record failed to document any in-services for any year of employment since their hire date of 3/25/2018. During an interview on 5/30/25 at 1:35 p.m., the administrator (ADM-1) and the Director of Nursing (DON-1) acknowledged the above findings, and ADM-1 stated, "HHA-1 is contracted, we do not in-service them, their staffing agency takes care of that."

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, the Agency failed to ensure Skilled Nursing provided adequate patient care instructions for the home health aide (HHa) regarding patient needs and safety precautions prior to the provision of care in 1 (Patient/P-1) of 1 record reviewed with HHa services ordered, from a total of 7 sampled records reviewed, resulting in the potential for unmet care needs and poor clinical outcomes for this patient. Findings include: This patient (P-1) was admitted to the home care Agency on 5/13/24, with diagnoses that included pressure ulcer (Stage-2) of sacral region, hemiplegia affecting left side of the body, COPD (chronic obstructive pulmonary disease), use of supplemental oxygen, and hypertension. The Plan of Care (POC/485) ordered aide services once weekly times 8 weeks. Skilled Nursing (SN) who created the aide POC effective 5/13/24, only included 4 of 15 safety precautions found on the POC/485, notably aspiration precautions, fall precautions, and to be wary of the combination of active smoking along with the use of oxygen. The aspiration precaution is significant due to documentation noted in the physician referral for home care which documented the following: "Patient is a 67-year-old paraplegic male with multiple recent admissions to (hospital)... CT scan revealed possible lung aspiration." The Administrator reviewed and acknowledged the above findings during an interview on 5/30/25 at 12:25 PM.

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 record review and interview, the Agency failed to ensure that the home health aide (HHa) plan of care included all pertinent safety precautions for 1 (Patient/P-1) of 1 record reviewed with aide services, out of a total sample of 7 records reviewed, resulting in the potential for unmet care needs and poor clinical outcomes for this patient. Findings include: This patient (P-1) was admitted to the home care Agency on 5/13/24, with diagnoses that included pressure ulcer (Stage-2) of sacral region, hemiplegia affecting left side of the body, COPD (chronic obstructive pulmonary disease), use of supplemental oxygen, and hypertension. The Plan of Care (POC/485) ordered aide services once weekly times 8 weeks. Skilled Nursing (SN) who created the aide POC effective 5/13/24, only included 4 of 15 safety precautions found on the POC/485, notably aspiration precautions, fall precautions, and to be wary of the combination of active smoking along with the use of oxygen. The aspiration precaution is significant due to documentation noted in the physician referral for home care which documented the following: "Patient is a 67-year-old paraplegic male with multiple recent admissions to (hospital)... CT scan revealed possible lung aspiration." The Administrator reviewed and acknowledged the above findings during an interview on 5/30/25 at 12:25 PM.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure a transfer summary was complete in 1 (Patient/P-1) of 1 record reviewed with a transfer, out of a total of 7 records reviewed, resulting in the potential for unidentified continuing health care concerns and unmet care needs. Findings include: This patient (P-1) was admitted to the home care Agency on 5/13/24, with diagnoses that included pressure ulcer (Stage-2) of sacral region, hemiplegia affecting left side of the body, COPD (chronic obstructive pulmonary disease), use of supplemental oxygen, and hypertension. On 5/29/25, record review revealed patient (P-1) was transferred to the hospital for pneumonia on 5/18/24 with the transfer summary being sent to the physician on 5/20/24. However, review of the content of the transfer summary noted numerous key areas being left blank which are as follows: "Allergies", "Vital Signs Ranges", "Patient Goals", "Goal Attainment Rate", "Oxygen Saturation", "Pain Levels", "Disciplines and Frequency of Visits", "Total Visits Provided" and "Reason for Admission to Home Health/Continued Services". The Administrator (Adm-1) reviewed and acknowledged the above findings during an interview on 5/30/251 at 12:45 PM. Adm-1 noted the transfer summary should have included more information.

A Medicare recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs on 6/21/22 through 6/23/22 at: Reliable Home Health Patient Care 29226 Orchard Lake Rd., Suite 210 Farmington Hills, MI 48334 At the conclusion of the survey, Suburban Home Care was found to be not in compliance with the requirements for participation in Medicare at 42 CFR 484.102, Emergency Preparedness. 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).

Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms "facility" or "facilities" in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This CONDITION is not met as evidenced by: This condition of Participation has NOT been met. Based on record review and interview, the Agency failed to develop an emergency preparedness plan that must be reviewed and updated at least every 2 years, and included guidance for the Covid-19 pandemic, resulting in lack of direction for Agency personnel in the event of an actual emergency or disaster. This deficient practice could affect the health and safety of all 10 patients actively serviced by this Agency in the event of a facility emergency or disaster (E0004); failed to complete an Emergency Preparedness Plan that was based on a facility and community based risk assessment (E0006); failed to develop and maintain an emergency preparedness training and testing program for staff based on the agency's emergency plan, resulting in agency personnel not being educated in actions to take in the event of an actual disaster. This deficient practice could affect all 10 patients currently serviced by this Agency (E0036); and failed to provide documentation for the required community based full-scale exercises and failed to provide documentation of an actual event that would qualify as a test of the emergency plan, resulting in staff being unprepared in the event of an actual emergency. This deficient practice could negatively affect all 10 patients actively serviced by this Agency (E0039). The cumulative effect of these systemic problems could potentially have a negative effect on all patients cared for by the home health agency in the event staff is not properly prepared for an emergency for the Condition of Participation of 42 CFR §485.102, Emergency Preparedness.

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on document review and interview, the Agency failed to develop and maintain an emergency preparedness program that included the required elements, that must be reviewed, and updated at least annually, resulting in the potential to affect the Agency's ability to provide safe patient care in the event of an actual emergency. Findings Include: On 6/22/22, review of the Agency's Emergency Preparedness Plan (EP) failed to provide any evidence that a review or updates had been documented. This deficient practice was confirmed during an interview with the ADM#1 (Administrator) at 10:00 am., on 6/23/22. ADM#1 stated, "We have not updated the Emergency preparedness program since COVID started." The Agency failed to develop and maintain an emergency preparedness program that included the required elements, that must be reviewed, and updated at least annually as required.

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 interview and record review, the Agency failed to conduct a facility-based and community-based risk assessment resulting in the potential for failure to identify hazards associated with the facility and less than optimal outcomes during an emergency event. This could potentially affect staff, and all patients serviced by this agency in the event of an emergency. Findings include: On 6/22/22 at 10:00 am., the ADM#1 (Administrator) was asked if the agency had conducted the required risk assessment and reported, "We have not updated the Emergency preparedness program since COVID started." Upon review of the presented documentation, there was no evidence that the facility conducted a risk assessment utilizing an all-hazards approach with regards to natural, man-made, facility and geographic related emergencies.

EP Training and Testing CFR(s): 484.102(d) §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, CAHs at §486.625, "Organizations" under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to develop and maintain an emergency preparedness training and testing program for staff based on the agency's emergency plan, resulting in agency personnel not being educated in actions to take in the event of an actual disaster. This deficient practice could affect all 10 patients currently serviced by this Agency. Findings include: During review of the agency's Emergency Preparedness documents and policies on 6/22/22, it was noted that the Agency did not have documented evidence that they had developed a training and testing program for staff that was based on the agency's emergency plan. The above findings were reviewed with and confirmed by the ADM#1 (Administrator) during an interview on 6/22/22 at 10:00 am, who stated, "We have not updated the Emergency preparedness program since COVID started."

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 annual tabletop and community based full-scale exercises or any documentation of an actual event that would qualify as a test of the emergency plan, resulting in staff not being properly prepared for an actual emergency. This deficiency has the potential to affect staff and all 60 patients serviced in the past 12 months by this agency, in the event of an emergency. Findings include: On 6/22/22, review of the Agency's Emergency Preparedness Plan (EP), it was noted that there was no evidence of any participation in a full-scale community-based exercise or an individual, facility-based full-scale exercise. There was no evidence the agency had completed any table-top exercises. When queried about emergency preparedness testing activities during an interview on 6/23/22 at 10:00 a.m., the ADM#1 (Administrator) replied, "We have not completed any exercises since COVID started."

A Medicare recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs from 6/21/22-6/23/22 at: Reliable Home Health Patient Care Co. 29226 Orchard Lake Rd., Suite 210 Farmington Hills, MI 48334 This agency has no branches or sub units. COVID-19 vaccinations were reviewed during this survey. For this survey, 2 records with home visits, 3 active records, and 2 discharge records were reviewed, for a total of 7 records reviewed.The following Condition Level deficiencies were identified: 42 CFR §484.55: Comprehensive Assessment of Patients 42 CFR §484.60: Care Planning, Coordination, Quality of Care 42 CFR§484.65: Quality Assessment and Performance Improvement (QAPI) 42 CFR § 484.70 Infection Control. 42 CFR§484.102: Emergency Preparedness 42 CFR§484.105: Organization and Administration of Services At the conclusion of the survey, it was determined that the agency was out of compliance at the condition level for the conditions of participation at 42 CFR Part 484, requirements for Home Health Agencies.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).

HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator's name, business address, and business phone number in order to receive complaints. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to include contact information for the Home Health Agency's Administrator in the Patient Admission/Orientation Packet for Skilled Nurse openings, resulting in the potential for unaddressed concerns for all patients serviced by this agency. Findings include: On 6/21/22 at 11:10 a.m., the Agency's Admission packet (for Skilled Nurse openings) was reviewed. The packet included a consent form, admission agreement, Beneficiary notice and patient rights and responsibilities forms. Upon review, it was noted that there was no contact information for the Agency's Administrator (Adm #1). These findings were reviewed with and confirmed by Adm #1 and the Clinical Manager (CM #1) during an interview on 6/22/22 at 4:00 p.m.

Contact info Federal/State-funded entities CFR(s): 484.50(c)(10)(i,ii,iii,iv,v) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: (i) Agency on Aging (ii) Center for Independent Living (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to advise their patients of the names, addresses and telephone numbers of federally funded and state-funded entities that serve the area where the patient resides, resulting in the potential for unmet patient care needs. Findings include: During a review of the Agency's patient admission packet (for Skilled Nurse openings) on 6/21/22 at 11:10 a.m., it was noted that the information for the Federally and State funded patient resource entities (Agency on Aging, Center for Independent Living, Protection and Advocacy Agency, Aging and Disability Resource Center and Quality Improvement Organization) had not been included. These findings were reviewed with and confirmed by the Administrator and Clinical Manager during an interview on 6/22/22 at 4:00 p.m.

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, the agency failed to ensure the registered nurse conducted the initial assessment of the patient for 1 of 7 (MR #6) records reviewed in which Skilled Nursing services were ordered, which has the potential to negatively affect the health and well-being of these patients. Findings include: MR#6: The Start of Care (SOC) was dated 5/19/22. The Plan of Care (POC) identified diagnoses of Hemiplegia, Low Back Pain and Left Hip Pain. During record review on 6/22/22, it was noted that the “Physician Home Care Order and Fact to Face Encounter” dated 5/17/22 stated, “Circle Disciplines Ordered: RN, PT.” On 5/19/22, the Physical Therapist completed a SOC OASIS (Outcome and Assessment Information Set). The Registered Nurse competed an evaluation visit on 5/24/22. The Registered Nurse failed to complete the initial assessment visit. These findings were attempted to be reviewed with the Administrator (Adm#1) on 6/23/22 at 10:30 am when the interview was terminated due to his aggressive tone, argumentative and denial behavior.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to conduct a patient-specific, comprehensive assessment that accurately reflected the patient's current health status based on past medical history that included dates of onset, exacerbations, treatments and outcomes, baseline data, and history of events leading to current home care needs in 4 of 7 records reviewed (MR#s 4, 5, 6, 7), resulting in incomplete clinical information to aide in determining the needs of the patient. Findings included: MR#4: The SOC was dated 6/3/22. The POC identified diagnoses of NSTEMI (Non-ST elevated myocardial infarction), hypotension, chronic kidney disease, and weakness. A review of the Comprehensive Assessment on 6/21/22, under the category of (M1021): "Diagnoses Symptom Control," The only information provided was a list of diagnoses. Under the Cardiac section, there was no information providing dates of onset, exacerbations, prior treatments and outcomes, or history of how the above illnesses/events led to the need for the current home care admission. MR#5: The SOC was dated 5/20/22. The POC identified diagnoses of radiculopathy, pain, diabetes and gout. During review of the Comprehensive Assessment on 6/22/22, it was discovered that no baseline blood sugar was documented for a patient with a diagnosis of diabetes. During a meeting on 6/23/22 at 1:00 p.m., the administrator (Adm#1) and the clinical manager (CM#1) acknowledged the above findings. MR#6: The Start of Care (SOC) was dated 5/19/22. The Plan of Care (POC) identified diagnoses of Hemiplegia, Low Back Pain and Left Hip Pain. During record review on 6/22/22, it was noted that the SOC comprehensive assessment dated 5/19/22, documented under "Primary Diagnosis and Other Diagnoses", all 10 diagnoses were blank under onset/exacerbation and date of the onset/exacerbation. No exacerbation, prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. MR#7: The Start of Care (SOC) was dated 11/4/21. The Plan of Care (POC) identified diagnoses of Diabetes Type 2, Herniated Disc and Hypertension. During record review on 6/21/22, it was noted that the SOC comprehensive assessment dated 11/4/21, documented under "Primary Diagnosis and Other Diagnoses", all 8 diagnoses were blank under onset/exacerbation and date of the onset/exacerbation. No exacerbation, prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. These findings were attempted to be reviewed with the Administrator (Adm#1) on 6/23/22 at 10:30 am when the interview was terminated due to his aggressive tone, argumentative and denial behavior.

Patient's needs CFR(s): 484.55(c)(4) The patient's medical, nursing, rehabilitative, social, and discharge planning needs; This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to ensure the patient's Activity of Daily Living needs were adequately met in the patient's home for 1 (MR's #2) of 2 patients assessed as needing assistance with ADLs; and failed to ensure 2 (MR #1, 2) of 2 patient's Medical Social Work needs were met, resulting in the potential for poor hygiene, psychological decline, lack of resources, and unmet care needs. Findings include: MR #1: The patient's start of care (SOC) was 4/8/22 with diagnoses that included Stroke with Facial Weakness and Monoplegia. During the record review on 6/21/22 at 1:05 p.m., it was noted that the Patient Rights section of the Initial Comprehensive Assessment dated 4/8/22 stated, "Add MSW (Medical Social work) for assistance with transport and community groups. During this review, it was further noted that no Medical Social Work services were provided or offered. MR #2: The patient's SOC was 5/11/22 with diagnoses that included Hypertension, Hypothyroidism and Paraplegia. The record review was conducted on 6/21/22 at 3:06 p.m. The Plan of Care (POC) revealed the following Functional Limitations: Ambulation, endurance, Dyspnea (difficulty breathing) with minimal exertion; Safety: Fall Precautions, Use of Assistive Devices, Support during Transfer/Ambulation, Cane, Walker. The Initial comprehensive Assessment dated 5/11/22 documented, "Patient lives alone No Assistance Available, Multiple Co-morbidities, Community resources needed, MSW referral needed for access to community resources." Section 1800 (Grooming) documented, "Someone must help..." At the time of this review, Home Health Aide services had not been offered or provided. Additionally, no MSW services had been provided as indicated. The Agency failed to ensure the patient's needs were adequately met in the patient's home. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Clinical Manager (CM #1) during an interview on 6/22/21 at 4:00 p.m.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined that the Agency (HHA) failed to ensure the comprehensive assessment included a review of all medications by a registered nurse (RN), to determine any adverse effects; and failed to ensure the physician was notified of potential drug interactions in 5 records (MR #2, 3, 5, 6, 7), from a total of 7 sampled records reviewed, resulting in the potential for harmful medication effects for all patients serviced by this Agency. Findings include: **Agency policy "Medication Monitoring/Orders/Teaching/Documentation" (Undated) stated, "Procedure: 1. Agency staff shall check all medications the patient is taking to identify and promptly report to the physician any significant side effects or contraindications including the following: … b. Medication incompatibility for potential interaction…2, For patients who receive therapy only, the Physical or Speech Therapist will record all the medications the patient is currently taking. The medications are reviewed by a nurse Clinical Supervisor or an RN (Registered Nurse) staff member. The physician is notified of any interactions or contraindications identified…” MR#5: The SOC was dated 5/20/22. The POC identified diagnoses of radiculopathy, pain, diabetes and gout. During review of the record on 6/22/22, it was discovered that the medication profile was signed by a physical therapist. There was no documentation in the record showing an RN had done a medication reconciliation. During a meeting on 6/23/22 at 1:00 p.m., the administrator (Adm#1) and the clinical manager (CM#1) acknowledged the above findings. MR #2 The patient’s SOC was 5/11/22 with diagnoses that included Hypothyroidism, COPD (Chronic Obstructive Pulmonary Disease) and Paraplegia. During the record review on 6/21/22 at 3:06 p.m. it was noted that the patient was transferred to the Hospital on 5/28/22 and resumed to care under the Agency's services on 6/13/22. Section M2001 of the Resumption of Care (ROC) Comprehensive Assessment dated 6/13/22, completed by the Physical Therapist (PT), documented “Yes - issues found during review.” Section M2003 asked, “Did the Agency contact a Physician by midnight of the next calendar day - Yes.” Upon further review, the only Medication Profile in the patient's chart was dated for 5/11/22 (SOC) and signed by the Registered Nurse. The patient's Medication Profile had not been updated upon the return to services, and there was no documented evidence that the PT conducted a drug review upon resumption to care. Additionally, there was no evidence that the Registered Nurse provided oversight of the drug review process or that the Physician had been notified of the identified issues. MR #3: The patient's SOC was 6/1/22 with diagnoses that included Low Back Pain and Spinal Stenosis. During the record review on 6/22/22 at 11:45 a.m., it was noted that section M2001 of the Initial Comprehensive Assessment dated 6/1/22 and completed by the Physical Therapist documented, "Yes - Issues found during review." Upon further review, there was no documentation of what the identified issues were, no evidence that the RN provided oversight of the drug review process and no evidence that the Physician had been made aware of the untoward findings. The deficiencies identified in the above records were reviewed with and acknowledged by Adm #1 and CM #1 during an interview on 6/22/22 at 4:00 p.m. MR#6: The Start of Care (SOC) was dated 5/19/22. The Plan of Care (POC) identified diagnoses of Hemiplegia, Low Back Pain and Left Hip Pain. During record review on 6/22/22, it was noted that the Physical Therapist completed the “Medication Profile” on 5/19/22 and here was no documented evidence that the patient's medications had been reviewed by a registered nurse for possible drug interactions and duplicate drug therapy. MR#7: The Start of Care (SOC) was dated 11/4/21. The Plan of Care (POC) identified diagnoses of Diabetes Type 2, Herniated Disc and Hypertension. During record review on 6/21/22, a medication interaction report was completed in the EMR (Electronic Medical Record) and noted 1 major drug to drug interaction: Gabapentin & Acetaminophen-Codeine. There was no documented evidence that the physician had been notified of the above findings. These findings were attempted to be reviewed with the Administrator (Adm#1) on 6/23/22 at 10:30 am when the interview was terminated due to his aggressive tone, argumentative and denial behavior.

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, it was determined the agency failed to ensure the plan of care included all safety measures to prevent injury, and measurable goals in 3 of 7 records (MR #4, 5, 6) from a total of 7 records reviewed. Resulting in the potential for injury and unmet care needs. Findings include: MR#4: The SOC was dated 6/3/22. The Plan of Care (POC) identified diagnoses of NSTEMI (Non-ST elevated myocardial infarction), hypotension, chronic kidney disease, and weakness. The POC had a visit frequency ordered for skilled nursing (SN) at 1 visit per week for 3 weeks. During further review of the POC, it was discovered that the SN goals were not measurable, for example, one goal stated, "Patient will demonstrate the ability to verbalize fall prevention methods during [sic] by 6/19/22." Another stated, "Patient and caregiver will be able to identify fall risk factors by 6/3/22." There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. During review of SN visits on 6/21/22, it was discovered that the SN only made one visit, the initial comprehensive assessment visit on 6/3/22. MR#5: The SOC was dated 5/20/22. The POC identified diagnoses of radiculopathy, pain, diabetes and gout. During review of the POC on 6/22/22, it was discovered that no diabetic precautions were documented for a patient with a diagnosis of diabetes. During a meeting on 6/23/22 at 1:00 p.m., the administrator (Adm#1) and the clinical manager (CM#1) acknowledged the above findings. MR#6: The Start of Care (SOC) was dated 5/19/22. The Plan of Care (POC) identified diagnoses of Hemiplegia, Low Back Pain and Left Hip Pain. During record review on 6/22/22, it was noted that the Skilled Nurse (SN) completed an evaluation on 5/24/22 and documented a frequency of 1w4 (1 time a week for 4 weeks). There was no evidence that the SN POC was ordered or generated that documented goals and interventions. These findings were attempted to be reviewed with the Administrator (Adm#1) on 6/23/22 at 10:30 am when the interview was terminated due to his aggressive tone, argumentative and denial behavior.

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 3 (MR#'s 1, 2, 3) of 3 patients with a Medication Profile that included the names, dosages and frequencies, indications for use and associated side effects of the patient's prescribed medication, in plain language, from a total of 7 sampled records reviewed, resulting in lack of direction for medication administration and the potential for improper use of medications. Findings include: MR's #1-3: During a review of Medical Records 1 through 3, it was noted that the Medication Profiles were void of all the required elements such as indication for use, associated side effects and the frequency in which the prescribed medications were to be taken. These findings were reviewed with and acknowledged by the Administrator and the Clinical Manager during an interview on 6/22/22 at 4:00 p.m.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to include contact information for the Home Health Agency's Clinical Manager in the Patient Admission/Orientation Packet for Skilled Nurse openings, resulting in the potential for unaddressed patient concerns. Findings include: On 6/21/22 at 11:10 a.m., the Agency's Admission packet (for Skilled Nurse openings) was reviewed. The packet included a consent form, admission agreement, Beneficiary notice and patient rights and responsibilities forms and Emergency Preparedness documents. Upon review, it was noted that there was no contact information for the Agency's Clinical Manager. These findings were reviewed with and confirmed by the Administrator (Adm #1) and Clinical Manager (CM #1) during an interview on 6/22/22 at 4:00 p.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 record review and interview, it was determined that the Agency failed to establish written policies and procedures to ensure all staff were fully vaccinated for the Covid-19 virus and failed to establish a contingency plan for those staff who were not vaccinated, resulting in the potential for the development and spread of the Covid-19 infection to staff and all patients currently serviced by this Agency (G687). The cumulative effect of these systemic problems resulted in the Agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR§484.70 Infection Control.

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 record review and interview, it was determined that the Agency failed to establish written policies and procedures to ensure all staff were fully vaccinated for the Covid-19 virus and failed to establish a contingency plan for those staff who were not vaccinated, resulting in the potential for the development and spread of the Covid-19 infection to staff and all patients currently serviced by this Agency. Findings include: On 6/22/22 at 9:42 a.m., a request was made to the Administrator (Adm #1), to review the Agency's Covid-19 Vaccine policy and reported, "We don't have a Vaccine policy." Adm #1 then provided the CMS Guidance titled, "Guidance for the Interim Final Rule..., Covid-19 Health Care Staff Vaccination" and stated, "This is our policy." The document was a letter drafted by CMS that informed Providers that they would be surveyed for compliance in this area. The Agency had not developed nor implemented a Covid-19 Vaccine policy. When asked if Agency staff had been vaccinated against the Covid-19 virus, Adm #1 reported, "All of the staff have been vaccinated." Adm #1 continued to state, "My Clinical Manager (CM #1) has not been vaccinated." When asked if CM #1 had a medical or religious waiver, Adm #1 reported, "She's (CM #1) not going to take it (vaccine) and she shouldn't have to because that's her right." It was explained that all persons have the right to refuse the vaccine, however a religious or medical waiver had to have been established. Adm #1 then reported, "I'll just have her (CM #1) write out a waiver when she comes in. It's just a piece of paper." Adm #1 provided a staff list which included 11 personnel. Upon review of the Agency's personnel files, it was noted that of the 11 staff members listed, 1 staff only received 1 of the 2 series vaccine and 3 staff had not been vaccinated. Additionally, the unvaccinated staff (Clinical Manager, Alternate Administrator, Office Staff) had no documented waivers on file. The Agency failed to establish written policies and procedures to ensure all staff were fully vaccinated against the Covid-19 virus in order to prevent the development and spread of the virus. These findings were reviewed with Adm #1 at the time of discovery and again during an interview with CM #1 present on 6/22/22 at 4:00 p.m.

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 disciplines failed to provide care and services as ordered in the Plan of care in 2 (MR's #1, 2) records of patients who required Medical Social Work, Occupational Therapy, Physical Therapy and Skilled Nursing services, from a total of 7 sampled records reviewed, resulting in the potential for physiological decline, psychological decline, lack of needed resources and unmet care needs. Findings include: MR #1: The patient's start of care (SOC) was 4/8/22 with diagnoses that included CVA (Stroke) with facial weakness and Monoplegia. During the record review on 6/21/22 at 1:05 p.m., it was noted that the patient was discharged from the Agency's services on 5/5/22. The Plan of Care (POC) ordered the patient to receive Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy and Medical Social Work services. At the time of this record review, no OT or MSW services had been provided as ordered prior to being discharged. During an interview on 6/22/22 at 4:00 p.m., the Administrator (Adm #1) was queried as to why the ordered services were not provided, yet was unable to offer explanation. MR #2: The patient's SOC was 5/11/22 with diagnoses that included Paraplegia, Hypertension and COPD (Chronic Obstructive Pulmonary Disease). During the record review on 6/21/22 at 3:06 p.m., it was noted that the POC ordered SN 1x/wk. x 4 wks. and PT 1x/wk. x 1 wk., 2x/wk. x 5 wks. SN saw the patient on 5/11/22 (SOC) and again on 5/18/22. There were no other SN visits made after 5/18/22. Additionally, there was no documented evidence of patient refusal of services or any indication that the patient had been discharged from SN services. PT saw the patient on 5/12/22, 5/17/22 and 5/19/22. PT missed visits on 5/23/22 and 5/26/22 and documented the patient was hospitalized. Further review of the clinical record revealed that the patient had not been hospitalized on the above missed visit dates. Additionally, there was no documented evidence that the patient refused PT services. The Agency failed to ensure that SN and PT services were provided as ordered. These findings were reviewed with and acknowledged by Adm #1 and the Clinical Manager (CM #1) during an interview on 6/22/22 at 4:00 p.m.

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on record review and interview, the Agency failed to provide documented evidence that the Administrator was appointed by and reported to the Governing Body, resulting in no definitive lines of authority and the potential for lack of oversight of patient needs (G946); the Administrator failed to ensure the Clinical Manager was available at all times during hours of operation, resulting in the potential for lack of clinical and supervisory oversight of patient care services and unmet care needs for all patients serviced by this agency (G950); failed to ensure the Clinical Manager coordinated services that were ordered on the referral form for 1 of 7 (MR #6) records reviewed and coordinated clinical oversight regarding staff scheduling and visit frequency for 1 of 7 (MR #6) records reviewed, resulting in services not being provided to this patient (G964); the Clinical Manager failed to ensure the Plans of Care were implemented in accordance with the Physician's orders in 2 (MR's #1, 2) of 3 records in which services were ordered and not provided, from a total of 7 sampled records reviewed, resulting in patients not receiving care and services to meet their individualized needs and the potential for decline in overall health status (G968). The cumulative effect of these systemic problems resulted in the Agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR§484.105 Organization and Administration of Services.

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 record review and interview, the Agency failed to provide documented evidence that the Administrator was appointed by and reported to the Governing Body, resulting in no definitive lines of authority and the potential for lack of oversight of patient needs. Findings include: On 6/22/22 at 10:45 a.m., the Administrator (Adm #1) was asked to provide the Governing Board meeting minutes that reflected the Administrator's appointment. Upon review of the Governing Body meeting minutes, there was no indication as to who had been appointment to assume the role of Administrator. The Agency failed to provide documented evidence of the appointment of a qualified Administrator that reported to the Governing Body.

Ensure clinical manager is available CFR(s): 484.105(b)(1)(iii) (iii) Ensure that a clinical manager as described in paragraph (c) of this section is available during all operating hours; This ELEMENT is not met as evidenced by: Based on observation and interview, it was determined the Administrator failed to ensure the Clinical Manager was available at all times during hours of operation, resulting in the potential for lack of clinical and supervisory oversight of patient care services and unmet care needs for all patients serviced by this agency. Findings include: On 6/21/22 at 10:35 a.m., upon completion of the Entrance Conference, the Administrator (Adm #1) was asked if the Clinical Manager (CM #1), who was not present during the conference, would be present during the survey and responded, "I'm not sure. I can try to contact her. She has a lot going on." At approximately 1:00 p.m., Adm #1 stated, "I've been trying, but I can't reach her and she's not returning my calls. I'll keep trying. At 3:30 p.m., Adm #1 approached the conference room with his cell phone in hand and stated he had the Clinical Manager on the speaker phone. CM #1 was asked if she would be joining the survey and responded, "I'm not available because I have a prior commitment. I can probably come tomorrow (6/22/22) around 3:30 or 3:45 p.m. depending on traffic" On 6/22/22 the Clinical Manager arrived to the Agency at 3:00 p.m. and upon introductions stated, "I finished earlier than I thought and traffic wasn't that bad." At 3:55 p.m., during interviews, to discuss identified patient care concerns, CM #1 was asked if she would be present the next day (6/23/22) for continuation of interviews (Agency closed at 5:00 p.m.) and be present during the exit and responded, "I'm unavailable. I have my own business as well." The Administrator failed to ensure the Clinical Manager was available at all times during the hours of operation. The above findings were also reviewed with the Administrator (Adm #1), who was present during the interview.

Coordinate referrals; CFR(s): 484.105(c)(3) Coordinating referrals, This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Clinical Manager coordinated services that were ordered on the referral form for 1 of 7 (MR #6) records reviewed and coordinated clinical oversight regarding staff scheduling and visit frequency for 1 of 7 (MR #6) records reviewed, resulting in services not being provided to this patient. Findings include: MR#6: The Start of Care (SOC) was dated 5/19/22. The Plan of Care (POC) identified diagnoses of Hemiplegia, Low Back Pain and Left Hip Pain. During record review on 6/22/22, it was noted that there was a Physician Home Care Order and Face to Face Encounter document with an attached “Encounter” note both dated 5/17/22. Within the “Encounter” note, it stated, “Plan: …Serum level of Carbamazepine and Keppra is needed. Did not change dosage since long ago…Start home physical therapy for pain management, balance training, and decreased endurance. Start with home nurse (Skilled Nursing) for monitoring, management, and education regarding meds, diet, and safety and blood draw for above testing listed.” There was no documentation of a lab being drawn of the completed Skilled Nursing (SN) visits on 5/24/22, 5/30/22 and 6/10/22. Additionally, the POC ordered SN at a frequency of 1w4 (1 visit a week for 4 weeks) and there is no documented evidence of the last SN visit being completed which was ordered to be during the dates of 6/12/22 through 6/18/22. The agency failed to provide clinical oversight of the required lab draw and coordination of services. These findings were attempted to be reviewed with the Administrator (Adm#1) on 6/23/22 at 10:30 am when the interview was terminated due to his aggressive tone, argumentative and denial behavior.

Assure implementation of plan of care CFR(s): 484.105(c)(5) Assuring the development, implementation, and updates of the individualized plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the Clinical Manager failed to ensure the Plans of Care were implemented in accordance with the Physician's orders in 2 (MR's #1, 2) of 3 records in which services were ordered and not provided, from a total of 7 sampled records reviewed, resulting in patients not receiving care and services to meet their individualized needs and the potential for decline in overall health status. Findings include: MR #1: The patient's start of care (SOC) was 4/8/22 with diagnoses that included Stroke with Facial Weakness. During the record review on 6/21/22 at 1:05 p.m., it was noted that the Plan of Care (POC) ordered Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT), and Medical Social work (MSW) services to be provided. The patient was discharged from the Agency on 5/5/22. At the time of this review, OT and MSW services had not been provided. The Clinical Manager (CM #1) failed to ensure the orders in the POC were followed. MR #2: The patient's SOC was 5/11/22. The POC ordered SN and PT services to be provided. During the record review on 6/21/22 at 3:06 p.m., it was noted that SN made a total of 2 visits and made no further visits after 5/25/22. The Physical Therapist had missed visits on 5/23/22 and 5/26/22. The PT documented that the patient was hospitalized, however, the patient was not hospitalized until 5/28/22. There was no documented rationale for the SN or PT missed visits. The clinical Manager failed to ensure the skilled disciplines provided care and services in accordance with the POC. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and the Clinical Manager (CM #1) during an interview on 6/22/22 at 4:00 p.m.

Skilled services furnished CFR(s): 484.105(f) Standard: Services furnished. Skilled nursing services and at least one other therapeutic service (physical therapy, speech-language pathology, or occupational therapy; medical social services; or home health aide services) are made available on a visiting basis, in a place of residence used as a patient's home. An HHA must provide at least one of the services described in this subsection directly, but may provide the second service and additional services under arrangement with another agency or organization. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to ensure that at least one qualifying service was provided directly by Agency employees, resulting in the potential for interruption in continuity of care and unmet care needs. Findings include: On 6/21/22 at 9:30 a.m., during the Entrance Conference, the Administrator (Adm #1) was asked what services were currently provided by the Agency and stated that Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT), Medical Social Work (MSW) and Home Health Aide (HHa) services were provided. When asked if the Agency utilized contract personnel, Adm #1 said, "Yes." When asked which of the above-mentioned services were provided by the contract agency, Adm #1 stated, "We contract SN, PT, MSW, OT and HHa services." When asked to clarify which of the services were directly provided by the Agency, Adm #1 reported, "SN and PT." Upon review of the Agency's contract, it was noted that the contract was with Achieve Rehab, Inc. and listed all disciplines (SN, PT, OT, ST (speech therapy), HHa and MSW) as contract services. The Agency failed to ensure that at least one qualifying service was provided directly by agency employees and not listed as an option under contracted services. These findings were reviewed with and acknowledged by Adm #1 and the Clinical Manager (CM #1) during an interview on 6/22/22 at 4:00 p.m.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure a discharge summary was complete, provided the patient's current health status at the time of discharge, progress toward goals, and forwarded to the physician within 5 days of discharge in 1 (MR# 7), of 2 closed records, from a total of 7 records reviewed, resulting in the potential for unidentified continuing health care concerns and unmet care needs. Findings include: MR#7: The Start of Care (SOC) was dated 11/4/21. The Plan of Care (POC) identified diagnoses of Diabetes Type 2, Herniated Disc and Hypertension. During record review on 6/21/22, it was noted that the agency failed to verify that the discharge summary was sent to the physician within 5 business days of the patient's discharge. These findings were attempted to be reviewed with the Administrator (Adm#1) on 6/23/22 at 10:30 am when the interview was terminated due to his aggressive tone, argumentative and denial behavior.