Every finding on record at Bethesda Home Health, LLC

A recertification survey for Emergency Preparedness was conducted by the Michigan Department of Licensing and Regulatory Affairs, on 4/12/23 through 4/14/23 at: Bethesda Home Health 30445 Northwestern Highway, Suite 107 Farmington Hills, MI 48334 At the time of the survey, the agency did not operate any branch offices or subunits. At the survey's conclusion, the agency was found to be in substantial compliance (standard citation) with the requirements for participation in Medicare/Medicaid at 42 CFR §484.102, Emergency Preparedness.

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to provide documentation that it had conducted exercises to test its emergency plan annually, by way of a tabletop and community based full-scale exercise required every two years, and failed to conduct an additional exercise at least every two years opposite the year of the full-scale exercise, resulting in the potential for patients and staff not to be properly prepared in the event of an actual emergency. Findings include: On 4/13/23 at 2:45 PM., review of the Agency's Emergency Preparedness (EP) binder found no evidence the Agency had conducted the required full-scale community-based exercise every two years. Additionally, no evidence was noted of an additional testing exercise scheduled every two years opposite of the full-scale exercise noted above, which included any clinical staff, or any patient related drills. No documentation of an actual emergency or event that could be substituted for an exercise was evidenced. Further review of the EP binder found the following documentation: "Called Oakland County emergency preparedness if there was a schedule or training regarding community-based drills/exercises of any kind (dated 11/23/22, 11/12/21, and 11/20/20)." The agency noted that no drills/exercises were scheduled at the time, and subsequently never participated in any community-based exercises during the last three years. However, a call was made on 4/14/23 at 9:55 AM., to Region's 2 North Healthcare Coalition to ascertain the frequency of EP community exercises held. It was verified that each year, three separate exercise drills were available for agencies to participate in. During an interview on 4/14/23 at 10:35 AM., the findings above were reviewed by the Administrator and Alternate Administrator, who both acknowledged the agency had failed to meet this requirement.

The following immediate jeopardy was identified during an onsite Medicare recertification survey conducted by the Michigan Department of Licensing and regulatory Affairs on 4/12/23 to 4/14/23 at: Bethesda Home Health 30445 Northwestern Highway, Suite 107 Farmington Hills, MI 48334 For this survey: 2 home visits with record reviews, 1 active records without a home visit and 4 discharged records were reviewed. For a total of 7 records reviewed. On 4/14/23 immediate jeopardy was determined to exist that began on 9/10/22 due to the facility's failure to ensure the Plan of Care (POC) included the diagnosis, pertinent interventions, education, and goals concerning non-compliant, uncontrolled diabetes, failed to have the POC include physician orders to provide wound care by skilled nursing, failed to have the POC acknowledge any instructions/details concerning enteral nutrition/tube feedings; and failed to incorporate ordered services from the home care referral into the POC (MR #4). The following Immediate Jeopardy Condition Level Citation was out of compliance as follows: 42 CFR §484.60: Care Planning, Coordination, Quality of Care. The agency's Administrator and Alternate Administrator were notified of the immediate jeopardy at 11:45 am on 4/14/23. The Immediate Jeopardy was removed on 4/14/23, but noncompliance remained at a Condition Level. ********************************************************************** The following standard and condition deficiencies were found during an onsite Medicare recertification survey conducted by the Michigan Department of Licensing and regulatory Affairs on 4/12/23 to 4/14/23: The following condition level deficiencies were identified: 42 CFR §484.55: Comprehensive Assessment of Patients. 42 CFR §484.60: Care Planning, Coordination Services, and Quality of Care. 42 CFR §484.105: Organization and Administration of Services. 42 CFR §484.110: Clinical Records. As a result of the condition level noncompliance found at the 4/14/23 recertification survey, 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).

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to incorporate pertinent baseline information from the referral detailing the patient's current health at the time of admission in 5 (MR#'s 1, 2, 3, 4, 7) of 7 records reviewed (See G 528); failed to ensure the registered nurse reviewed patient medications for possible side effects and possible drug interactions for 3 (MR#'s 2, 6, 7) of 3 physical therapy records reviewed, failed to ensure the medication profile was accurate for 1 (MR#1) of 7 records reviewed; and failed to complete the "High Risk Medication" sheet for 2 (MR#'s 3, 4) of 7 records reviewed (See G 536). 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 and a poor clinical outcome concerning the Condition of Participation of 42 CFR §484.55 Comprehensive Assessment of Patients.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment accurately reflected the patient's current health status at the time of admission in 5 (MR#'s 1, 2, 3, 4, 7) of 7 records reviewed, resulting in incomplete clinical information in determining the needs of patients and a poor clinical outcome. Findings include: MR#1: The Start of Care (SOC) was dated 9/5/22. The Plan of Care (POC) identified diagnoses of Sarcopenia, Polyarthritis, Shortness of Breath and Chronic Obstructive Pulmonary Disease. During record review on 4/12/23, it was noted that the SOC comprehensive assessment dated 9/5/22, documented under "Primary Diagnosis and Other Diagnoses", all 6 diagnoses had an exacerbation date of 9/5/22. No onset, prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. MR#2: The Start of Care (SOC) was dated 3/22/23. The Plan of Care (POC) identified diagnoses of Sarcopenia, Low Back Pain and Muscle Weakness. During record review on 4/13/23, it was noted that the SOC comprehensive assessment dated 3/22/23, documented under "Primary Diagnosis and Other Diagnoses", all 6 diagnoses had an exacerbation date of 3/22/23. No onset, prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. MR#3: The Start of Care (SOC) was dated 2/21/23. The Plan of Care (POC) identified diagnoses of Chronic Venous Hypertension with Ulcer, Sarcopenia and Peripheral Vascular Disease. During record review on 4/13/23, it was noted that the SOC comprehensive assessment dated 2/21/23, documented under "Primary Diagnosis and Other Diagnoses", all 6 diagnoses had an exacerbation date of 2/21/23. No onset, prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. These findings were reviewed with and acknowledged by the Administrator (Adm.#1) and Alternate Administrator (A-Adm.) during an interview on 4/14/23 at 11:30 am. MR#4: The patient’s start of care (SOC) date was 9/10/22, with primary diagnoses which included neuropathy-unspecified, and pressure ulcer (stage 2) of left lower back. The referral for home noted the patient as an uncontrolled, non-compliant IDDM. The patient’s A1C on 1/31/22 during an ER visit was 12.9 with a blood sugar of 315, and close monitoring needed. On 4/13/23, review of the SOC Comprehensive Assessment performed by RN#1, found no history noted in the referral or any extent as to the severity of the patient's diabetes. Further, the initial assessment identified 6 total diagnoses but failed to include the patient's diabetes. All 6 diagnoses under section M1021 "Primary Diagnosis" and M1023 "Other Diagnoses" had date(s) of onset as the SOC date, which was found to be inaccurate when compared to the history found within the physician referral. In addition, RN#1 documented no wound measurements of the "lower left glutes" and "coccyx" due to the following: "Unable to measure, patient unable to tolerate position." However, RN#1 documented performing wound care and under comments documented that the patient "tolerated well." The patient was found deceased in his home on 10/8/22, and due to insufficient clinical records, the agency was unable to show documentation which described potential contributing factors leading to the patient's death. The above findings were reviewed with and acknowledged by the Administrator and Alternate Administrator during an interview on 4/14/23 at 9:20 AM. MR #7: The SOC date was 12/1/21, with diagnoses which included Sarcopenia (muscle loss), Left Hip Osteoarthritis, and Hypertensive Heart Disease with Heart Failure. On 4/12/23, review of the referral for home care noted that during a physical exam by the physician dated 11/29/21, patient's weight was 160 pounds, with no noted edema (swelling) found. On 12/1/21, the Physical Therapist performed the SOC assessment (therapy only case) and documented the patient's weight had increased to 180 pounds and had "positive weeping edema" in both legs. The amount or degree of lower leg edema was left blank on the assessment. Further, all 6 diagnoses under section M1021 "Primary Diagnosis" and M1023 "Other Diagnoses" had date(s) of onset as the SOC date, which was found to be inaccurate when compared to the history found within the physician referral. The above findings were reviewed with and acknowledged by the Administrator and Alternate Administrator during an interview on 4/13/23 at 3:48 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 registered nurse reviewed patient medications for possible side effects and possible drug interactions for 3 of 3 (MR's 2, 6, 7) Physical Therapy records reviewed, failed to ensure the medication profile was accurate for 1 of 7 (MR#1) records reviewed, failed to complete the "High Risk Medication" sheet for 2 of 7 (MR#'s 3, 4) records reviewed. This deficient practice results in the potential for unrecognized medication side effects and drug interactions that could affect all patients serviced by the agency. Findings included: MR#4: The Start of Care (SOC) was dated 9/10/22. The Plan of Care (POC) identified diagnoses of Hereditary and Idiopathic Neuropathy-unspecified, General Paresis (partial paralysis), and Chronic Pressure Ulcer of Left Lower Back-stage 2. On 4/13/23, the referral for home care was reviewed and it was noted the POC performed by Skilled Nursing, had failed to include the patient's Diabetes, which was severely uncontrolled with an A1C level (provides overall picture of blood sugar control) of 12.9% (normal is less than 5.7%). Further review of the medication profile revealed that the patient was on Insulin for Diabetes. Additional review found the "High-Risk Medication Checklist" signed by the patient on 9/10/22, was blank. Subsequently, this negated the form's sole purpose of educating the patient on precautions/dangers associated with high-risk medications such as Insulin that the patient was on. MR#6: The SOC was dated 12/28/23. The POC identified diagnoses of Bilateral Knee Osteoarthritis, Heart Disease, and Hypertension. During record review on 4/13/23, it was noted that the Physical Therapist (PT) completed the “Medication Reconciliation Review” on 12/28/22. Further review found no documented evidence that the patient's medications had been reviewed by a Registered Nurse for possible drug interactions and duplicate drug therapy as required. MR#7: The SOC was dated 12/1/21, with diagnoses which included Sarcopenia (muscle loss), Congestive Heart Failure, and Hypertension. During record review on 4/13/23, it was noted that the PT completed the “Medication Reconciliation Review” on 12/1/21. Additional review found no documented evidence that the patient's medications had been reviewed by a Registered Nurse for possible drug interactions and duplicate drug therapy as required. The above findings were reviewed with and acknowledged by the Administrator (Adm.#1) and Alternate Administrator (A-Adm.) during an interview on 4/13/23 at 3:44 PM. **Agency policy "Medication Reconciliation" (Revised February 2021) stated, "Procedure: The Agency provides the patient and/or caregiver with written patient medication schedule/instructions…In therapy only cases, the therapist submits a list of medications collected during the comprehensive assessment to RN (Registered Nurse) for review, who contacts physician/practitioner if indicated.” MR#1: The Start of Care (SOC) was dated 9/5/22. The Plan of Care (POC) identified diagnoses of Sarcopenia, Polyarthritis, Shortness of Breath and Chronic Obstructive Pulmonary Disease. During record review on 4/12/23, it was noted that the Registered Nurse completed a comprehensive assessment on 9/5/22 and documented, “O2 (Oxygen) 2 LPM (Liters per minute) via cannula intermittent… Dependent to supplemental O2…Supplies/equipment: Oxygen concentrator.” The medication profile completed on 9/5/22 failed to include Oxygen. MR#2: The Start of Care (SOC) was dated 3/22/23. The Plan of Care (POC) identified diagnoses of Sarcopenia, Low Back Pain and Muscle Weakness. During record review on 4/13/23, it was noted that the Physical Therapist completed the “Medication Profile” on 3/22/23 and there 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#3: The Start of Care (SOC) was dated 2/21/23. The Plan of Care (POC) identified diagnoses of Chronic Venous Hypertension with Ulcer, Sarcopenia and Peripheral Vascular Disease. During record review on 4/13/23, it was noted that the High Risk Medication Checklist signed by the patient on 2/21/23 was blank. Review of the medication profile revealed that the patient was taking Oxycodone HCI 5mg every 6 hours as needed for pain. The “Narcotic Pain Relievers” section of the High Risk Medication Checklist failed to disclose the patients Oxycodone medication, thus the patient not receiving education. These findings were reviewed with and acknowledged by the Administrator (Adm.#1) and Alternate Administrator (A-Adm.) during an interview on 4/14/23 at 10:45 am. Based on record review and interview, the agency failed to ensure the registered nurse reviewed patient medications for possible side effects and possible drug interactions for 3 of 3 (MR#'s 2, 6, 7) Physical Therapy records reviewed, failed to ensure the medication profile was accurate for 1 of 7 (MR# 1) records reviewed, failed to complete the "High Risk Medication" sheet for 2 of 7 (MR#'s 3, 4) records reviewed. This deficient practice results in the potential for unrecognized medication side effects and drug interactions that could affect all patients serviced by the agency. Findings included:

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on record review and interview, it was determined that the agency failed to ensure the Plan of Care (POC) included the diagnosis, pertinent interventions, education, and goals concerning non-compliant, uncontrolled diabetes, failed to have the POC include physician orders to provide wound care by skilled nursing, failed to have the POC acknowledge any instructions/details concerning enteral nutrition/tube feedings; and failed to incorporate ordered services from the home care referral into the POC in 1 (MR #4) of 7 records reviewed; and failed to have the POC monitor for signs and symptoms of fluid overload, and provide interventions/treatments for severe lower leg edema in 1 (MR #7) of 1 record reviewed with Congestive Heart Failure, from a total sample of 7 records reviewed (See G 574); failed to ensure the patient was provided wound care as ordered for 1 (MR #3) of 1 record reviewed with wound care orders (See G 580); and failed to ensure the physician was promptly notified of significant weight gain and severe lower leg edema for 1 (MR #7) of 1 record reviewed with congestive heart failure, from a total of 7 sampled records reviewed (See G 590). The cumulative effect of these systemic problems resulted in the determination and approval for Immediate Jeopardy concerning 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.

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 the patient was provided wound care for 1 of 1 record reviewed (MR #3) with wound care, for a potential of improper wound care and unmet care needs. Findings include: MR#3: The Start of Care (SOC) was dated 2/21/23. The Plan of Care (POC) identified diagnoses of Chronic Venous Hypertension with Ulcer, Sarcopenia and Peripheral Vascular Disease. During record review on 4/13/23, it was noted that the POC ordered skilled nursing at a frequency of 1w3 (1 time a week for 3 weeks), 2w1. The referral contained a wound care order stating, “BLE (Bilateral Lower Extremities) Vascular ulcers, cleanse with NS (Normal Saline), apply dry dressing QOD (Every other day) x 14 days then discontinue.” A physicians order dated 2/21/23 stated, “Cleanse BLE (Bilateral Lower Extremities) venous stasis ulcers with normal saline, apply abd pad, wrap with kerlix, secure with tape using aseptic technique. Should be done daily by caregiver until Unna Boots are obtained. The comprehensive assessment completed by the Registered Nurse (RN) on 2/21/23 documented, “Pt (Patient)/CG (Caregiver) willing to do wound care? No… Patient may benefit with Unna Boot. Unna Boot ordered.” The following skilled nursing visit was dated 3/1/23, 8 days after the SOC stated, “Unna Boot applied.” The agency failed to provide wound care as ordered from 2/21/23 through 3/1/23 or document Pt/CG knowledge of wound care. These findings were reviewed with and acknowledged by the Administrator (Adm.#1) and Alternate Administrator (A-Adm.) during an interview on 4/14/23 at 11:20 am.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the Agency had failed to promptly notify the Physician concerning significant weight gain and severe lower leg edema for 1 (MR #7) of 1 patient with congestive heart failure, resulting in the potential for untreated health concerns and the potential for a poor clinical outcome. Findings include: MR #7: The start of care (SOC) date was 12/1/21, with diagnoses which included Sarcopenia (muscle loss), Left Hip Osteoarthritis, and Hypertensive Heart Disease with Heart Failure. On 4/12/23, review of the referral for home care noted that during a physical exam by the physician dated 11/29/21, patient's weight was 160 pounds with no noted edema (swelling) found. On 12/1/21, the Physical Therapist performed the SOC assessment (therapy only case) and documented the patient's weight had increased to 180 pounds and had "positive weeping edema" in both legs. The amount or degree of lower leg edema was left blank on the assessment. The Plan of Care was void of any detailed assessments/interventions which would monitor and treat for further exacerbation (worsening) of the patient's heart failure. Additional review of the clinical record found no documentation (additional orders and communication notes) that the physician had been notified concerning the significant change in the patient's condition noted above. The above findings were reviewed with and acknowledged by the Administrator and Alternate Administrator during an interview on 4/13/23 at 3:48 PM.

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 document review and interview, the agency failed to ensure the Clinical Manager coordinated services that were ordered on the referral form in 3 (MR's# 3, 4, 5) of 7 records reviewed (See G 964); failed to ensure the Clinical Manager consistently monitored and assessed the patient's needs throughout the certification period in 2 (MR#'s 4, 7) of 7 records reviewed (See G 966); and failed to ensure the plans of care were updated according to the patients' needs in 1 (MR #3) of 7 records reviewed (See G 968). This deficient practice could negatively affect the health and safety of all 16 agency patients serviced in the past 12 months, resulting in the potential for poor patient outcomes. 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. Based on document review and interview, the agency failed to ensure the Clinical Manager coordinated services that were ordered on the referral form (See G 964); failed to ensure the Clinical Manager consistently monitored and assessed patient needs to ensure services were provided as ordered (See G 966) and failed to ensure the plans of care were updated according to the patients' needs (See G 968). This deficient practice could negatively affect the health and safety of all 16 agency patients serviced in the past 12 months, resulting in the potential for poor patient outcomes. 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.

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 that 3 (MR's# 3, 4, 5) of 7 patients, out of a total sample of 7 records reviewed, were appropriately informed of their overall planning of care, including informing the patient/caregiver in advance of the specific disciplines providing care with associated visit frequencies, resulting in a lack of informed consent, inclusion in care planning, and the potential for missed visits and unmet care needs. Findings MR#3: The Start of Care (SOC) was dated 2/21/23. The Plan of Care (POC) identified diagnoses of Chronic Venous Hypertension with Ulcer, Sarcopenia and Peripheral Vascular Disease. During record review on 4/13/23, it was noted that the referral stated, “HHC (Home Health Care): PT (Physical Therapy)/OT (Occupational Therapy) Nurse/Nurse Aide (Home Health Aide). The consent signed by the patient on 2/21/23 was blank and the comprehensive assessment completed by Registered Nurse on 2/21/23 were blank under OT and HHA sections and there was no documentation of the patient refusing OT and HHA. The agency failed to provide services as ordered. These findings were reviewed with and acknowledged by the Administrator (Adm.#1) and Alternate Administrator (A-Adm.) during an interview on 4/14/23 at 10:50 am. MR#4: The patient’s start of care (SOC) date was 9/10/22, with primary diagnoses which included neuropathy-unspecified, and pressure ulcer (stage 2) of left lower back. The referral for home (9/8/22) noted a total of 14 listed diagnoses, including dysphagia following cerebral infarction (stroke) and the ordered the following services to furnish care: SN (Skilled Nursing), PT (Physical Therapy), OT (Occupational Therapy), ST (Speech Therapy), and HHa (Home Health Aide). Only SN and PT were listed on the 485, with no refusal or explanation as to why the ordered services from the referral were not furnished. MR#5: On 4/13/23, review for the referral for home care dated 4/12/23, noted orders for Physical Therapy for strengthening and Skilled Nursing to monitor vitals, medication and nutrition management. During a joint start of care home visit (10:35 through 12:25 PM.) with Skilled Nursing (SN) on 4/13/23, it was observed at 11:10 AM., the SN had the patient sign the consent informing the patient of the assigned disciplines with associated visit frequencies. Towards the end of the visit at 12:10 PM., SN was requested by the surveyor to go back and review the informed consent noted above. SN then acknowledged the consent had been left blank concerning the assigned disciplines with the intended visit frequencies. SN then filled out the form and reviewed the added information with the patient. After the visit outside of the patient's home, SN acknowledged the failure to coordinate the disciplines ordered from the referral into the consent for the patient review. These findings were reviewed with and acknowledged by the Administrator and Alternate Administrator during an interview on 4/13/23 at 4:05 PM.

Assure patient needs are continually assessed CFR(s): 484.105(c)(4) Assuring that patient needs are continually assessed, and This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the home health agency failed to ensure the patient needs were continually assessed during the certification period for 2 (MR#'s 4, 7) of 7 records reviewed, resulting in a poor clinical outcome and the potential of unmet care needs for all 16 patients serviced within the last 12 months. Findings include: MR#4: The patient’s start of care (SOC) date was 9/10/22, with primary diagnoses which included neuropathy-unspecified, and pressure ulcer (stage 2) of left lower back. The referral for home noted the patient as an uncontrolled, non-compliant IDDM. The patient’s A1C on 1/31/22 during an ER visit was 12.9 with a blood sugar of 315, and close monitoring was needed. On 4/13/23, further review of the record found no assessments, interventions or treatments throughout the certification period concerning the patient's diagnoses of wounds and diabetes after 9/10/23. The patient was found deceased in his home on 10/8/22, and due to insufficient clinical records, the agency was unable to show documentation which described potential contributing factors leading to the patient's death. In addition, these findings remained undiscovered until the findings were reviewed with agency during the recertification survey. The above findings were reviewed with the Administrator and Alternate Administrator during an interview on 4/13/23 at 4:19 PM., where it was acknowledged the agency failed to assess and meet the needs of the patient as required. MR #7: The SOC date was 12/1/21, with diagnoses which included Sarcopenia (muscle loss), Left Hip Osteoarthritis, and Hypertensive Heart Disease with Heart Failure. On 4/12/23, review of the referral for home care noted that during a physical exam by the physician dated 11/29/21, patient's weight was 160 pounds, with no noted edema (swelling) found. On 12/1/21, the Physical Therapist performed the SOC assessment (therapy only case) and documented the patient's weight had increased to 180 pounds and had "positive weeping edema" in both legs. The amount or degree of lower leg edema was left blank on the assessment. Additional review of the clinical record found no further documentation addressing the above findings while being admitted to homecare until 1/11/21. The above findings were reviewed with the Administrator and Alternate Administrator during an interview on 4/13/23 at 3:48 PM., where it was acknowledged the agency failed to have a process in place to ensure the deficient practice findings noted above were recognized by the agency and were remedied to facilitate the provision of safe, quality care.

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 Director failed to ensure the plan of care was updated as needed for 1 of 7 (MR #3) records reviewed, resulting in a potential decline in physical functioning, and verification of the patient's well-being. Findings include: MR#3: The Start of Care (SOC) was dated 2/21/23. The Plan of Care (POC) identified diagnoses of Chronic Venous Hypertension with Ulcer, Sarcopenia and Peripheral Vascular Disease. During record review on 4/13/23, it was noted that a resumption of care comprehensive assessment was started on 3/28/23 by the RN but has not been completed. Additionally, the agency has failed to complete a POC and the RN has started incomplete visits on 3/31/23, 4/3/23, 4/6/23 and 4/11/23. These findings were reviewed with and acknowledged by the Administrator (Adm.#1) and Alternate Administrator (A-Adm.) during an interview on 4/14/23 at 11:25 am.

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record was complete and included all clinical notes and complete medical records for 4 (MR#’s 1, 2, 3, 4) of 7 records reviewed (See G 1012); and failed to ensure a discharge summary was forwarded to the physician within 5 days of discharge in 3 (MR#’s 1, 4, 6) of 4 discharged records and 2 days of transferring to an inpatient facility in 1 (MR# 1) of 1 record in which the patient was transferred to an inpatient facility, resulting in the physician/receiving facility not having knowledge of the patient's health status at the time of transfer, the physician not having a clear picture of the patient's status at the time of discharge, the potential for unidentified continuing health care concerns and unmet care needs (See G 1022). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR§484.110 Clinical Records.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record was complete and included all clinical notes and complete medical records for 4 (MR#’s 1, 2, 3, 4) of 7 records reviewed, resulting in the potential to negatively affect the health and well-being of these patients. Findings include: MR#1: The Start of Care (SOC) was dated 9/5/22. The Plan of Care (POC) identified diagnoses of Sarcopenia, Polyarthritis, Shortness of Breath and Chronic Obstructive Pulmonary Disease. During record review on 4/12/23, it was noted the POC had Physical Therapy (PT) frequency of 2w5 (12times per week for 5 weeks), 1w2. On 10/6/22, the Physical Therapy Assistant (PTA) completed a visit and signed the “Signature Sheet” with the time in of 5:15 pm and time out of 6:00 pm. The Electronic Medical Record (EMR) failed to have a documented visit by the PTA on 10/6/22. Additionally, the comprehensive assessment completed by the Registered Nurse (RN) on 9/5/22 documented, “Homebound Reason: …Patient is homebound due to dementia…” The referral and POC failed to document a diagnosis of dementia. MR#2: The Start of Care (SOC) was dated 3/22/23. The Plan of Care (POC) identified diagnoses of Sarcopenia, Low Back Pain and Muscle Weakness. During record review on 4/13/23, it was noted that the comprehensive assessment completed by the RN on 3/22/23 documented, “Homebound Reason: …Patient is homebound due to dementia…” The referral and POC failed to document a diagnosis of dementia. MR#3: The Start of Care (SOC) was dated 2/21/23. The Plan of Care (POC) identified diagnoses of Chronic Venous Hypertension with Ulcer, Sarcopenia and Peripheral Vascular Disease. During record review on 4/13/23, it was noted that the patient was transfer to the hospital on 3/21/23 and was discharged home on 3/28/23. A resumption of care comprehensive assessment was started on 3/28/23 by the RN but has not been signed and contains the same exact documentation and verbiage from the RN SOC on 2/21/23 comprehensive assessment. Additionally, a physician’s order dated 3/28/23 is unsigned and undated by the discipline and displays “In Progress”. Furthermore, the RN has started visits on 3/31/23, 4/3/23, 4/6/23 and 4/11/23 but has not been completed. These findings were reviewed with and acknowledged by the Administrator (Adm.#1) and Alternate Administrator (A-Adm.) during an interview on 4/14/23 at 11:05 am. MR#4: The patient’s start of care (SOC) date was 9/10/22, with primary diagnoses which included neuropathy-unspecified, and pressure ulcer (stage 2) of left lower back. On 4/13/23, review of the clinical record revealed significant omissions concerning the following: 1) OASIS (Outcome and Assessment Information Set) Death at Home, 2) Skilled Nursing (SN) home visits (2 of 2 opportunities), 3) SN clinical instructions for direct care, 4) SN wound history and notes. 1) OASIS information surrounding the patient's death or potential contributing factors was not evidenced within the patient's medical record. 2) SN visits scheduled on 9/13/22 and 9/23/22 were found to be not started. No explanation, physician notification or patient refusal was found in the medical record. 3) Review of the clinical record found 3 of 3 "Clinical Instructions" concerning start of care OASIS and direct care surrounding SN visits were not started. 4) All "Wound Notes" and "Wound History" in the clinical record were found to have no documentation of assessments, interventions or treatments regarding the care provided to the patient's multiple wounds noted at the SOC initial assessment. The above findings were reviewed with and acknowledged by the Administrator and Alternate Administrator during an interview on 4/13/23 at 4:19 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 discharge summary was complete, provided the patient's health status at the time of discharge, progress toward goals, and forwarded to the physician within 5 days of discharge in 3 (MR#'s 1, 4, 6) of 4 discharged records; and failed to ensure a transfer summary was sent to the physician/receiving facility within 2 business days of the patient's transfer for 1 (MR #3) of 1 record in which the patient was transferred to an inpatient facility, resulting in the physician/receiving facility not having knowledge of the patient's health status at the time of transfer, the physician not having a clear picture of the patient's status at the time of discharge, the potential for unidentified continuing health care concerns and unmet care needs. Findings include: MR#1: The Start of Care (SOC) was dated 9/5/22. The Plan of Care (POC) identified diagnoses of Sarcopenia, Polyarthritis, Shortness of Breath and Chronic Obstructive Pulmonary Disease. During record review on 4/12/23, 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. MR#3: The Start of Care (SOC) was dated 2/21/23. The Plan of Care (POC) identified diagnoses of Chronic Venous Hypertension with Ulcer, Sarcopenia and Peripheral Vascular Disease. During record review on 4/13/23, it was noted that the agency failed to verify that the transfer summary was sent to the physician within 2 business days of the patient's transfer. These findings were reviewed with and acknowledged by the Administrator (Adm.#1) and Alternate Administrator (A-Adm.) during an interview on 4/14/23 at 10:55 am. Agency Policy: "Discharge Summary" (undated) stated, "A Discharge Summary will be sent within 5 business days of patient discharge to the primary care practitioner or other health care professional who will be responsible to the patient... The Discharge Summary will include, but is not limited to: Types of services provided and frequency of services, Patient outcomes in meeting goals in the plan of care, Patient/family post-discharge instructions, goals and treatment preferences, Medications at the time of discharge..." Agency Policy: "Transfer/Referral Criteria and Planning" (undated) stated, "A written Transfer Summary concerning the Agency's involvement with the patient, e.g., patient condition at transfer, lab data, patient outcomes in meeting goals in the plan of care, current reconciled medication list, any continuing symptom management needs... will be provided within two business days of becoming aware of an unplanned transfer..." MR #4: This patient was admitted to the agency on 9/10/22, and a discharge OASIS D1 (outcome and assessment information set) Death at Home form was completed by the Physical Therapist (PT) on 10/31/22. Record review on 4/12/23, found the "Discharge Summary" dated 10/10/22, to be blank. This finding was reviewed with the Administrator (Adm.#1) and Alternate Administrator (A-Adm.) during an interview on 4/13/23 at 4:19 PM. It was acknowledged by the Agency that the patient had passed in their residence on 10/8/22, and the Agency had failed to send a completed Discharge Summary timely as required to the physician. In addition, the Agency administration was under the impression that a discharge summary did not have to be completed if a discharge OASIS was filled out. MR#6: This patient was admitted to the agency on 12/28/22. On 4/13/23, review of the clinical record noted a discharge OASIS, and a "Discharge Summary" was completed by the PT on 1/30/23. The "Discharge summary was found to be blank and record review noted the discharge OASIS was sent out to the physician on 2/17/23 (14 business days after discharge). The above findings for were reviewed with and acknowledged by the Administrator and Alternate Administrator during an interview on 4/14/23 at 11:28 AM.