Every finding on record at Uns Home Health Agency, Inc

On 7/22/24 through 7/25/24, an Emergency Preparedness survey was conducted by the Michigan Department of Licensing and Regulatory Affairs. During the survey, Advisacare Solutions of Kalamazoo was not in compliance with the requirements for participation in Medicare at 42 CFR 484.102 Emergency Preparedness. The following standard level deficiency was identified.

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 participated in the community based full-scale exercise required every two years, resulting in the potential for patients and staff not to be properly prepared in the event of an actual emergency. Findings include: On 7/22/24 at 11:30 AM., review of the Agency's Emergency Preparedness binder found no evidence the Agency had conducted the required full-scale community-based exercise every two years. No communication or effort was noted by the Agency in reaching out to the local incident command center to participate in the community-based exercise for the last 4 years. The above findings were reviewed with and acknowledged by the Administrator during an interview on 7/22/24 at 2:24 PM.

The following condition level deficiencies were identified during the Medicare recertification survey conducted by the Michigan Department of Licensing and Regulatory Affairs (LARA) on 7/22/24 through 7/25/24 at: Advisacare Solutions of Kalamazoo 5401 Portage Rd., Suite 1 Portage, MI 49002 At the time of survey, the HHA did not operate any branch sites. For this survey, 7 records with home visits, 5 active records without home visits, and 5 discharged records were reviewed, for a total of 17 records reviewed. In addition, a focused review of 9 patient records receiving Occupational Therapy services was performed. As a result of the Condition level noncompliance found during the 7/25/24 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).

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the patient/caregiver were able to participate in the choice of accepting all health care disciplines ordered on the referral for home care in 1 (P-14) of 1 record reviewed with ordered social work services, failed to offer home health aide services when ordered in 3 (P-3, 10, 11) of 3 records reviewed with home health aide ordered, and failed to offer home health aide services when patient/caregiver were paying out of pocket for a covered benefit in 1 (P-15) of 3 record reviewed with home health aide needs, out of a total sample of 17 records reviewed, resulting in the lack of provision of care needs and the potential for poor outcomes. Findings include: P-14: This patient was admitted to the Agency on 7/20/24 with diagnoses of osteoporosis with right hip replacement, urinary tract infection, repeated falls, and diabetes-type 2. On 7/23/24, record review noted the physician on the referral for home care ordered the disciplines of skilled nursing, physical therapy, occupational therapy, and social work services to evaluate and treat the patient. No evidence was found in the medical record why social work services were not provided as no patient refusal or physician communication was found in the medical record. Further, during survey entrance on 7/22/24, the Administrator (Staff A) acknowledged the Agency did not offer any social work services directly (W-2) or via contract (1099). This finding was reviewed and acknowledged by Staff A and the Director of Operations (Staff C) during an interview on 7/25/24 at 11:25 AM. Staff A further acknowledged the Agency should not have accepted the patient in the first place since social work services could not be provided at the time. P-15: The patient was admitted to the Agency on 2/8/24, with diagnoses which included pressure ulcer-stage 3 on left buttock and hip, diabetes-type 2, and congestive heart failure (CHF). On 7/23/24, record review noted the lone ordered discipline was skilled nursing (SN) with a visit frequency of 1w1 (once a week for one week), 3w8, and 1w1. However, further record review noted the initial comprehensive assessment (dated 2/8/24) performed by SN had documented the following, "Care is done by paid caregivers three times daily. She (P-15) requires assistance with daily activities." No refusal of home health aide services or physician notification was evidenced during record review. No explanation was found in the medical record why the Agency allowed the patient/caregiver to pay out of pocket for an eligible covered benefit. The above finding was reviewed and acknowledged by the Administrator (Staff A) during an interview on 7/25/24 at 11:30. P-10: This 75-year-old patient was admitted to home care on 6/28/24 with diagnoses of metastatic Mullein adenocarcinoma and paraneoplastic neuromyopathy. During record review on 7/23/24, it was noted that the referral for home care, dated 6/27/24, ordered skilled nursing, physical therapy, occupational therapy, and home health aide (HHa) for “ADL (activities of daily living) assistance, evaluation, and personal care assistance.” During the entrance interview on 7/22/24 at 10:45 a.m., the director of operations (Staff C) stated the agency did not have any patients with aide services and the active clinician roster did not include any HHa staff. During a home visit on 7/24/24 at 1:00 p.m., the patient was observed sleeping in a hospital bed in the living room. The start of care OASIS, dated 6/28/24, indicates the patient is dependent for all ADL skills. The patient’s husband/primary caregiver was interviewed on 7/24/24 at 1:50 p.m. and queried if the agency had offered home health services. He stated he did not refuse HHa services, and that he and his daughter are covering current care needs and could benefit from the additional support. There was no documented evidence the patient or caregiver refused aide services or that the physician was notified. P-11: This 75-year-old patient was admitted to home care on 6/10/24 with diagnoses of abdominal wound, pulmonary embolism, and malnutrition. During record review on 7/23/24, it was noted that the referral for home care, dated 6/7/24, ordered physical therapy, occupational therapy, and home health aide (HHA) to “assist with ADLs and bathing.” During a home visit on 7/24/24 at 9:00 a.m., the patient was queried if he was offered HHa services. The patient states his wife has been assisting with his ADLs. There was no documented evidence the patient was offered or refused HHa services or that the physician was notified. These findings were reviewed by the administrator (Staff A), the clinical manager (Staff B), and the director of operations (Staff C) during an interview on 7/25/24 at 9:40 a.m. Staff C stated the provider is notified by intake staff that HHa services are not available at time of referral. Staff C stated the occupational therapist can train family to provide ADL assistance or the agency can offer private duty services (at cost to the patient). P-3: The Start of Care (SOC) was dated 6/6/24. The Plan of Care (POC) identified diagnoses of Pulmonary Fibrosis, Hypertensive Heart Disease and Congestive Heart Failure. During record review on 7/23/24, it was noted that the referral stated, “Services Ordered: SN (Skilled Nursing)/PT (Physical Therapy)/OT (Occupational Therapy) to eval and treat. HHA (Home Health Aide) for personal grooming.” The consent signed by the patient on 6/6/24 and the comprehensive assessment completed by Registered Nurse on 6/6/24 were blank under HHA section and there was no documentation of the patient refusing HHA services. This finding was reviewed with and acknowledged by the Staff A (Administrator) and Staff C (Director of Operations) during an interview on 7/24/24 at 2:40 pm.

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the comprehensive assessment was completed within 5 calendar days of the start of care in 1 (P-10) of 17 records reviewed (see G520); failed to ensure the comprehensive assessment accurately reflected the patient's health status and included diagnoses in 1 (P-8) of 1 sample records reviewed for which therapy was the only service ordered by the physician; and failed to ensure the comprehensive assessment incorporated the diabetic health care needs in 2 (P-15, P-16) of 5 records reviewed with diabetes, from a total of 17 records reviewed, resulting in a poor clinical outcome and incomplete clinical information to determine the needs of the patient (See G 528); failed to ensure clinicians included a review of all medications during the comprehensive assessment in order to identify any potential adverse effects and drug reactions in 5 (P-8, P-9, P-10, P-11, and P-12) of 17 sample records reviewed, and failed to perform a medication reconciliation as required after a resumption of care (ROC) post-hospitalization in 1 (P-15) of 2 records reviewed with ROC visits, resulting in the potential for unknown side effects, drug interactions, duplicate therapies, and poor patient outcomes (see G536); and failed to ensure the comprehensive assessment was updated after hospital discharge and return to the same home health agency for 1 (P-10) of 3 records reviewed in which the patient was transferred, resulting in the potential for unmet care needs and an inaccurate reflection of the patient’s health status (see G546). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR §484.55 Comprehensive Assessment of Patients.

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment was completed within 5 calendar days of the start of care in 1 (P-10) of 17 records reviewed, resulting in a delay in determining the immediate care and support needs for this patient. Findings include: P-10: This 75-year-old patient was admitted to home care on 6/28/24 with diagnoses of metastatic Mullein adenocarcinoma and paraneoplastic neuromyopathy. During record review on 7/23/24, it was noted that the referral for home care, dated 6/27/24, ordered skilled nursing, physical therapy, occupational therapy, and home health aide (HHA). Physical therapy evaluated the patient on 7/10/24, 12 days after the start of care. There was no evidence the physician was notified. This finding was reviewed and acknowledged by the administrator (Staff A), the clinical manager (Staff B), and the director of operations (Staff C) during an interview on 7/25/24 at 9:40 a.m.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment accurately reflected the patient's health status and included diagnoses in 1 (P-8) of 1 sample records reviewed for which therapy was the only service ordered by the physician; and failed to ensure the comprehensive assessment incorporated the diabetic health care needs for 2 (P-15, P-16) of 5 records reviewed with diabetes, from a total of 17 records reviewed, resulting in a poor clinical outcome and incomplete clinical information to determine the needs of the patient. Findings include: P-15: The patient was admitted to the Agency on 2/8/24, with diagnoses which included pressure ulcer-stage 3 on left buttock and hip, diabetes-type 2, and congestive heart failure (CHF). P-15 is currently on a second recertification episode (6/7/24 through 8/5/24) for continuing health needs noted above. On 7/23/24, review of the referral for home (2/6/24) care concerning the patient's diabetes noted the following documentation: "(Pt) had difficulties in the past with insulin administration given L AKA (left above the knee amputation) and R BKA (right below the knee amputation), difficulties self-preparing and administrating insulin as patient requires assistance and her home Hoyer lift to ambulate out of bed to refrigerator... Check blood sugars four times per day and log result." Review of the initial comprehensive assessment performed by skilled nursing (SN) documented on page 20 of 33 the following: "She does not check her blood sugar regularly. Daughter checks it sometimes when she comes over." Despite the above findings from the referral and lack of blood sugar checks noted during the comprehensive assessment, the SN failed to obtain any blood sugar readings during the comprehensive assessment visit with no refusal of the patient being noted. Further record review of the current episode found SN failed to perform any blood sugar checks in 21 of 21 SN visits. These findings were reviewed and acknowledged by the Administrator (Staff A) and the Director of Operations (Staff C) during an interview on 7/25/24 at 11:35 AM. P-16: The SOC date was on 9/11/23, with diagnoses which included chronic pain, urinary tract infection (UTI), and diabetes-type 2. On 7/24/24, review of the initial comprehensive assessment performed by SN on 9/11/23 noted the following documentation concerning the patient's diabetes on page: "(Patient) reports he does not check BS's (blood sugars) on a regular basis in the home because they are always in the low 100's." SN documented P-16 was positive for diabetic neuropathy with active insulin use for the past 10 years, and under "Blood Sugar" SN documented "N/a (not applicable)". No explanation or refusal by the patient was evidenced in the medical record as to why SN did not check P-16's BS during the initial assessment. In addition, SN left BS safety parameters blank under "Notify physician of" which would have then populated onto the patient's Plan of Care. Subsequently, 14 of 14 SN visits failed to obtain any BS readings (9/11/23 through 10/11/23). Further record review revealed a SN note (Staff H) on 10/13/23 which documented, "Pt (patient) presented with lightheadedness, confusion, and was having difficulty with communicating with SN upon beginning of visit. BS taken, which resulted in 37. SN administered 8 oz. of cranberry juice. Pt also ate two snack sized candy bars. BS was retaken after 15 minutes in which result was 36. EMS contacted. Upon paramedics(s) arrival, BS was 57. EMS indicated they would remain with patient until BS WNL (within normal limits) or else patient would be transferred to ER. PCP (primary care provider) notified of episode." Record review found SN performed 3 of 3 BS checks on 10/16/23 (BS 137), 10/18/23 (BS 115), and 10/20/23 (BS124). However, SN failed to perform BS checks during the next 4 home visits. On 11/1/23, SN documented P-16's BS at 188. P-16 was transferred to the hospital on 11/3/23 for reasons unrelated to diabetes. These findings were reviewed and acknowledged by the Administrator (Staff A) and the Director of Operations (Staff C) during an interview on 7/25/24 at 11:35 AM. Both agreed SN should have assessed the patient during the comprehensive assessment and SN failed to meet Agency expectations and follow its policy referenced below. Agency Policy: "Comprehensive Assessment and OASIS Data Collection Start of Care" Section III.8 (undated) stated, "Care of patients is based upon a comprehensive assessment process. It is established by the Agency in coordination with regulatory requirements to gather and analyze specific data to determine the initial and continuing health care needs and services of the patient and patient care outcomes. Patient assessment data are collected through a combination of methods including interaction with patient/family, observation and measurement." Agency policy titled “III.8 Comprehensive Assessment and OASIS Data Collection Start of Care” (undated), was reviewed on 7/25/24. On pages 2-3, it stated “The comprehensive assessment will include, at a minimum… All pertinent diagnoses…” P-8: This 89-year-old was admitted to agency on 7/3/24 with pain to thoracic spine, low back, and both shoulders (as determined by a face-to-face signed physician form on 7/17/24). The medical record was reviewed on 7/25/24. It was noted that the comprehensive assessment was completed on 7/3/24 by the physical therapist. In section “((M1021) Primary Diagnosis & (M1023) Other Diagnoses”, the comprehensive assessment was left blank of all description of diagnoses; severity of disease; or date of onset/exacerbation. The patient’s health status was unclear at the time of the comprehensive assessment, and at the time of this medical record review (22 days after the comprehensive assessment). This finding was reviewed and acknowledged during interview on 7/25/24 at 8:20 a.m. with the Administrator (Staff A); the Clinical Manager (Staff B); and the Director of Operations (Staff C).

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 clinicians included a review of all medications during the comprehensive assessment in order to identify any potential adverse effects and drug reactions in 5 (P-8, P-9, P-10, P-11, and P-12) of 17 sample records reviewed, and failed to perform a medication reconciliation as required after a resumption of care (ROC) post-hospitalization in 1 (P-15) of 2 records reviewed with ROC visits, resulting in the potential for unknown side effects, drug interactions, duplicate therapies, and poor patient outcomes. Findings include: P-8: This 89-year-old was admitted to agency on 7/3/24 with pain to thoracic spine, low back, and both shoulders. The medical record was reviewed on 7/25/24. During review, it was noted that the comprehensive assessment was completed on 7/3/24 by the physical therapist (PT). In section (M2001) “Drug Regimen Review” of the comprehensive assessment, the PT marked the box which indicated yes, issues were found during medication review, and in section (M2003) “Medication Follow-up” marked the box which indicated “No” the agency did not contact the physician within 24 hours for recommended action in response to identified potential clinically significant medication issue. No further explanation of the identified medication issue was documented in the medical record. It was also noted that medications were entered on the agency “Medication Profile” on 7/3/24, however, no Patient Medication Record acknowledging review of medications for potential adverse effects and drug reactions or acknowledgment by the admitting clinician was ever entered into the medical record (22 days after start of care). This finding was reviewed and acknowledged by the Administrator (Staff A) during interview on 7/25/24 at 8:20 a.m. P-9: This 77-year-old patient was admitted to home care on 4/20/24 with diagnoses of type 2 diabetes, hypertensive heart and chronic kidney disease, and congestive heart failure. During record review on 7/22/24, it was noted that the electronic medical record failed to include a patient medication record report or medication review acknowledgement from the admitting registered nurse. P-10: This 75-year-old patient was admitted to home care on 6/28/24 with diagnoses of metastatic Mullein adenocarcinoma and paraneoplastic neuromyopathy. During record review on 7/23/24, it was noted that the electronic medical record failed to include a patient medication record report or medication review acknowledgement from the admitting registered nurse. P-11: This 75-year-old patient was admitted to home care on 6/10/24 with diagnoses of abdominal wound, pulmonary embolism, and malnutrition. During record review on 7/23/24, it was noted that the drug regimen review (M2001) on start of care OASIS, dated 6/10/24, stated issues were found during review and the physician was notified. The patient medication record stated, “no concerns noted at this time” and indicated the physician was not notified. P-12: This 69-year-old patient was admitted to home care on 2/7/24 with diagnoses of acute lymphoblastic leukemia and anemia. During record review on 7/24/24, it was noted that the electronic medical record failed to include a patient medication record report or medication review acknowledgement from the registered nurse completing the recertification assessment. These findings were reviewed and acknowledged by the administrator (Staff A), the clinical manager (Staff B), and the director of operations (Staff C) during an interview on 7/25/24 at 9:40 a.m. P-15: The patient was admitted to the Agency on 2/8/24, with diagnoses which included pressure ulcer-stage 3 on left buttock and hip, diabetes-type 2, and congestive heart failure (CHF). P-15 is currently on a second recertification episode (6/7/24 through 8/5/24) for continuing health needs noted above. On 7/23/24, record review noted P-15 was transferred and admitted to the hospital on 5/4/24 through 5/16/24, for a urinary tract infection and hypertension control. On 5/16/24, skilled nursing (SN) performed a Resumption of Care (ROC) visit, but no medication reconciliation was evidenced in the medical record as required. This finding was reviewed and acknowledged by the Administrator (Staff A) during an interview on 7/25/24 at 1130 AM. The facility failed to adhere to its policy referenced below. Agency Policy: "M2001: Drug Review" Section N: Medications, (effective 1/1/2023) stated, "Time Points Item(s) Completed... Resumption of Care: Complete a drug regimen review as close to the actual time of SOC/ROC as possible. Potential or actual clinically significant medication issues may include, but are not limited to, the following: Adverse reactions... ineffective drug therapy... side effects... drug interactions... duplicate therapy..."

Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment was updated after hospital discharge and return to the same home health agency for 1 (P-10) of 3 records reviewed in which the patient was transferred, resulting in the potential for unmet care needs and an inaccurate reflection of the patient’s health status. Findings include: P-10: This 75-year-old patient was admitted to home care on 6/28/24 with diagnoses of metastatic Mullein adenocarcinoma and paraneoplastic neuromyopathy. During record review on 7/23/24, it was noted that a skilled nursing transfer summary, dated 7/3/24, stated the patient returned to the hospital “having collapsed at home with daughters. States that client blood cultures came back positive and that she is being treated for a blood infection with IV antibiotics.” The record contained a missed visit form from 7/5/24 stating the patient may be discharged this evening and home health visits will resume next week. On 7/8/24, the registered nurse provided a skilled nursing visit. There was no evidence a resumption of care assessment or medication reconciliation was completed. This finding was reviewed and acknowledged by the administrator (Staff A), the clinical manager (Staff B), and the director of operations (Staff C) during an interview on 7/25/24 at 9:40 a.m.

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 that each patient receive home health services that are written in an individualized plan of care per agency policy in 2 (P-5 and P-8) of 17 sample records reviewed (See G572); failed to ensure the Plan of Care (POC) included measurable outcomes and goals for skilled nursing, and reportable parameters in 15 (P-1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 15, 16, 17) of 16 total records reviewed with skilled nursing services, and failed to ensure therapy services were aware of the need for supplemental oxygen when treating the patient in 1 (P-13) of 2 records reviewed with supplemental oxygen needs, out of a total of 17 records reviewed, resulting in the potential for poor patient outcomes due to a lack of quantifiable measures and a lack of guidance concerning potential oxygen adjustments to optimize blood oxygen levels with activity (See G 574); failed to ensure treatment was provided only as ordered by the physician in 1 (P-6) of 17 sample records resulting in the potential to negatively affect the health and well-being of this patient (See G580); and failed to ensure the physician was notified of changes in the patient's condition in 2 (P-3, 13) of 11 records reviewed with therapy services, resulting in a poor clinical outcome, and weight gain in 1 (P-3) of 6 patients with congestive heart failure, from a total sample of 17 records reviewed (See G 590). 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 CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure that each patient receive home health services that are written in an individualized plan of care per agency policy in 2 (P-5 and P-8) of 17 sample records reviewed resulting in a delay in identifying patient specific measurable outcome and goals and progress toward them. Findings include: Agency policy titled “III.7 Professional /Ancillary Care Plans” (undated), was reviewed on 7/24/24. On the second page it stated, “An individualized plan of care… shall be developed and implemented by each professional discipline providing service… The plans of care, which shall be developed within 3-5 days of the initial assessment, shall conform to the physician’s plan of treatment…” P-5: This 69-year-old was admitted to agency on 7/8/24 with diagnoses including acute pyelonephritis (kidney infection); pulmonary fibrosis (disease which scars the lungs and causes difficulty breathing); and Chronic Obstructive Pulmonary Disease (progressive lung disease causing breathing difficulties). The medical record was reviewed on 7/22/24. During review, it was noted that the plan of care (POC) was not yet entered into the electronic medical record and had a status indicating “Not Started” (14 days after the initial start of care assessment) and that nurse had made a total of 5 visits. It was noted that the POC had been entered into the medical record on day 15 post start of care (7/23/24). During interview on 7/25/24 at 8:20 a.m. with the Administrator (Staff A), Staff A agreed that agency policy stated the POC would be established by 3-5 days from initial assessment. Staff A continued to explain that the medical record had been in the process of coding and the POC was entered when coding was finished and agreed that 15 days was too long. Staff A stated that the department which provides the service was very behind. P-8: This 89-year-old was admitted to agency on 7/3/24 with pain to thoracic spine, low back, and both shoulders. The medical record was reviewed on 7/25/24. During review, it was noted that the comprehensive assessment was completed on 7/3/24 by the physical therapist (PT); the occupational therapist (OT) completed an evaluation on 7/10/24; and the POC had not yet been entered into the electronic medical record and had a status indicating “Not Started” (22 days after the initial start of care assessment). PT and OT had been making weekly visits after each of their evaluations. During interview on 7/25/24 at 8:20 a.m., Staff A stated that the reason there was no POC completed was due to not having diagnoses entered on the comprehensive assessment which was not the expectation of the agency.

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 (POC) included measurable outcomes and goals for skilled nursing, and reportable parameters in 15 (P-1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 15, 16, 17) of 16 total records reviewed with skilled nursing services, and failed to ensure therapy services were aware of the need for supplemental oxygen when treating the patient in 1 (P-13) of 2 records reviewed with supplemental oxygen needs, out of a total of 17 records reviewed, resulting in the potential for poor patient outcomes due to a lack of quantifiable measures and a lack of guidance concerning potential oxygen adjustments to optimize blood oxygen levels with activity. Findings include: P-13: The start of care (SOC) date was on 6/21/24, with diagnoses which included chronic obstructive pulmonary disease (COPD), heart failure, and dependence on supplemental oxygen. On 7/23/24, record review revealed the POC's goals for skilled nursing (SN) were not objectively measurable. For example, P-13 had 2 of 2 listed goals documented as follow: "Patient stated outcome to be achieved within this episode of care is: Without hospitalization throughout episode (Target Date 8/19/24). Patient will have diagnosis specific interventions throughout this episode of care to monitor co-morbidities and potential adverse events, to reduce the risk of acute hospitalization. (Target Date 8/19/24)." No SN goals were found which addressed P-13's primary diagnoses of COPD and heart failure. In addition, the POC failed to acknowledge the use of oxygen under "Interventions" when working with the patient for both physical therapy (PT) and occupational therapy (OT) services. Subsequently, PT and OT had no orders to titrate (adjust) fluctuating oxygen levels when working with the patient, putting P-13's safety at risk. P-15: The SOC date was on 2/8/24, with diagnoses which included pressure ulcer-stage 3 on left buttock and hip, diabetes-type 2, and congestive heart failure (CHF). On 7/23/24, record review revealed the POC's goals for SN were not objectively measurable. For example, P-15 had 2 of 2 listed goals documented as follow: "Pt (patient) will have diagnosis specific interventions throughout this episode of care to monitor co-morbidities and potential adverse events, to reduce the risk of acute hospitalization (Target Date 4/7/24). Wounds will heal without complication by: Discharge (Target Date 4/7/24)." P-16: The SOC date was on 9/11/23, with diagnoses which included chronic pain, urinary tract infection (UTI), and diabetes-type 2. On 7/24/24, record review revealed the POC's goals for SN were not objectively measurable. For example, P-16 had 2 of 2 listed goals documented as follow: "Wound(s) will heal without complication by: end of episode (Target Date 11/9/24). Pt (patient) will have diagnosis specific interventions throughout this episode of care to monitor co-morbidities and potential adverse events, to reduce the risk of acute hospitalization (Target Date 11/9/24)." No SN goals were found which addressed P-16's primary diagnoses of chronic pain, UTI, and diabetes. P-17: The SOC date was on 11/25/23, with diagnoses which included acute respiratory failure with hypoxia (low oxygen level in the body), bronchiectasis (damaged lung airways) with (acute) exacerbation, and unspecified open wound of left buttock. On 7/24/24, record review revealed the POC's goals for SN (5 of 5) were not objectively measurable. For example, "Pt will maintain weight diet compliance during the episode (Target Date 12/29/23). Pt will have diagnosis specific interventions throughout this episode of care to monitor co-morbidities and potential adverse events, to reduce the risk of acute hospitalization (Target Date 1/23/24)." No SN goals were found which addressed P-17's primary diagnoses of respiratory failure with hypoxia or wound healing. P-9: This 77-year-old patient was admitted to home care on 4/20/24 with diagnoses of type 2 diabetes, hypertensive heart and chronic kidney disease, and congestive heart failure. During record review on 7/22/24, it was noted that the plan of care failed to include patient-specific interventions for monitoring diabetes. The plan of care included the diabetic patient nursing intervention to “perform diabetic foot inspections each visit.” The plan failed to include parameters for glucose monitoring, or inventions for monitoring and education for diabetes. It was also noted that the plan of care failed to include measurable nursing goals that were individualized to address patient needs. For example, one goal stated, “patient will have diagnosis specific interventions throughout this episode of care to monitor co-morbidities and potential adverse events, to reduce the risk of acute hospitalization.” Another goal stated, “both will verbalize understanding of medication regimen, dose, route, frequency, indications, and side effects by 05/02/2024.” There was no evidence of how these goals could be objectively measured to determine progress toward meeting the goals. P-10: This 75-year-old patient was admitted to home care on 6/28/24 with diagnoses of metastatic Mullein adenocarcinoma and paraneoplastic neuromyopathy. During record review on 7/23/24, it was noted it was noted that the plan of care failed to include measurable nursing goals that were individualized to address patient needs. For example, one goal stated, “client will show demonstrate improvement in cognition, strength, and show progress in meeting her functional goals set forth by PT/OT (physical/occupational therapy) in setting of metastatic mullein adenocarcinoma with paraneoplastic syndrome r/t (related to) chemo.” [sic] Another goal stated, “patient will have diagnosis specific interventions throughout this episode of care to monitor co-morbidities and potential adverse events, to reduce the risk of acute hospitalization.” There was no evidence of how these goals could be objectively measured to determine progress toward meeting the goals. P-11: This 75-year-old patient was admitted to home care on 6/10/24 with diagnoses of abdominal wound, pulmonary embolism, and malnutrition. During record review on 7/23/24, it was noted it was noted that the plan of care failed to include measurable nursing goals that were individualized to address patient needs. For example, one goal stated, “patient will have diagnosis specific interventions throughout this episode of care to monitor co-morbidities and potential adverse events, to reduce the risk of acute hospitalization.” Another goal stated, “patient will improve ability to safely complete upper body ADL's (activities of daily living) with minimal assistance using compensatory strategies as needed.” There was no evidence of how these goals could be objectively measured to determine progress toward meeting the goals. P-12: This 69-year-old patient was admitted to home care on 2/7/24 with diagnoses of acute lymphoblastic leukemia and anemia. During record review on 7/24/24, it was noted it was noted that the plan of care failed to include measurable nursing goals that were individualized to address patient needs. For example, one goal stated, “patient will have diagnosis specific interventions throughout this episode of care to monitor co-morbidities and potential adverse events, to reduce the risk of acute hospitalization.” Another goal stated, “client and caregiver will demonstrate understanding of flushing central line.” There was no evidence of how these goals could be objectively measured to determine progress toward meeting the goals. These findings were reviewed and acknowledged by the administrator (Staff A), the clinical manager (Staff B), and the director of operations (Staff C) during an interview on 7/25/24 at 9:40 a.m. P-5: This 69-year-old was admitted to agency on 7/8/24 with diagnoses including acute pyelonephritis (kidney infection); pulmonary fibrosis (disease which scars the lungs and causes difficulty breathing); and Chronic Obstructive Pulmonary Disease (progressive lung disease causing breathing difficulties). The medical record was reviewed on 7/22/24. During review, the following examples of the Skilled Nursing (SN) goals were noted on the plan of care (POC) dated 7/8/24: patient will have diagnosis specific interventions throughout this episode of care to monitor co-morbidities and potential adverse events, to reduce the risk of acute hospitalizations; patient will be free from signs and symptoms of respiratory distress during the episode; patient stated outcome to be achieved within this episode of care is: “patient wants to be placed”. It is unclear how these goals were specific to this patient’s diagnoses, and how they would be measured in terms that would enable nursing staff to accurately perform an objective evaluation of the patient’s progress toward the goals. P-6: This 82-year-old was admitted to agency on 2/10/23 with diagnoses including pressure ulcer to the sacral region; paralysis of lower extremities; and incontinence of bowel/bladder. The medical record was reviewed on 7/23/24. During review, the following were the only SN goals noted on the POC with certification date 6/4/24 to 8/2/24: the patient will have no hospitalizations during the certification period; patient will have diagnosis specific interventions throughout this episode of care to monitor co-morbidities and potential adverse events, to reduce the risk of acute hospitalization; patient stated outcome to be achieved within this episode of care is: “wound to be closed”. It is unclear how these goals were specific to this patient’s diagnoses, and how they would be measured in terms that would enable nursing staff to accurately perform an objective evaluation of the patient’s progress toward the goals. P-7: This 82-year-old was admitted to agency on 12/18/23 with diagnoses including pressure ulcer of the left and right heels; type 2 Diabetes; and chronic heart failure. The medical record was reviewed on 7/24/24. During review, the following were the only SN goals noted on the POC with certification date 6/15/24 to 8/13/24: patient stated outcome to be achieved within this episode of care is: “Be free from falls during episode”; patient will have diagnosis specific interventions throughout this episode of care to monitor co-morbidities and potential adverse events, to reduce the risk of acute hospitalization; the patient will have no hospitalizations during the certification period. It is unclear how these goals were specific to this patient’s diagnoses, and how they would be measured in terms that would enable nursing staff to accurately perform an objective evaluation of the patient’s progress toward the goals. These findings were reviewed and acknowledged by the Administrator (Staff A), the Clinical Manager (Staff B), and the Director of Operations (Staff C) during interview on 7/25/24 at 8:20a.m. P-1: The Start of Care (SOC) was dated 6/11/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure and End Stage Renal Disease. During record review on 7/22/24, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Pt (Patient) will have diagnosis specific interventions throughout this episode of care to monitor co-morbidities and potential adverse events, to reduce the risk of acute hospitalization.” Additionally, another goal stated, “Patient will be without signs or symptoms of UTI (pain, foul odor, cloudy or blood-tinged urine and fever) during this episode.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. P-2: The Start of Care (SOC) was dated 10/12/23. The Plan of Care (POC) identified diagnoses of Right Lower Leg Wound, Hypertension and Cerebral Palsy. During record review on 7/23/24, it was noted that the goal within the POC was not measurable. The one goal stated, “Pt will have diagnosis specific interventions throughout this episode of care to monitor co-morbidities and potential adverse events, to reduce the risk of acute hospitalization.” There was no evidence of how this goal could be objectively measured to ascertain progress toward goal. P-3: The Start of Care (SOC) was dated 6/6/24. The Plan of Care (POC) identified diagnoses of Pulmonary Fibrosis, Hypertensive Heart Disease and Congestive Heart Failure. During record review on 7/23/24, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Patient will be free from signs and symptoms of respiratory distress during the episode.” Additionally, another goal stated, “Pt will have diagnosis specific interventions throughout this episode of care to monitor co-morbidities and potential adverse events, to reduce the risk of acute hospitalization.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. P-4: The Start of Care (SOC) was dated 6/14/24. The Plan of Care (POC) identified diagnoses of Sepsis, Diabetes Type 2 and Left Foot Ulcer. During record review on 7/25/24, it was noted that the goal within the POC was not measurable. The one goal stated, “Pt will have diagnosis specific interventions throughout this episode of care to monitor co-morbidities and potential adverse events, to reduce the risk of acute hospitalization.” There was no evidence of how this goal could be objectively measured to ascertain progress toward goal. Additionally, it was documented that the patient was a diabetic and the POC failed to contain parameters to notify the physician of blood sugar irregularities. The POC failed to contain the blood sugar parameters to notify the physician. These findings were reviewed with and acknowledged by the Staff A (Administrator) and Staff C (Director of Operations) during an interview on 7/24/24 at 2:40 pm and 7/25/24 at 12:25 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 treatment was provided only as ordered by the physician in 1 (P-6) of 17 sample records resulting in the potential to negatively affect the health and well-being of this patient. Findings include: P-6: This 82-year-old was admitted to agency on 2/10/23 with diagnoses including pressure ulcer to the sacral region; paralysis of lower extremities; and incontinence of bowel/bladder. The medical record was reviewed on 7/23/24. During review, it was noted that the patient had a foley catheter (urinary bladder catheter) for urine drainage, and the plan of care (POC) for the certification period of 6/4/24 to 8/2/24 included orders for skilled nursing to change the foley catheter every 3 weeks. It was also documented that the last foley catheter change was prior to the current re-certification period on 6/3/24 and the next foley catheter change was scheduled for 6/24/24 (3 weeks or 21 days from 6/3/24). There were no skilled nursing visits on 6/24/24. On 6/26/24, the Licensed Practical Nurse (LPN) documentation indicated the foley catheter change was scheduled for 6/24/24 (2 days prior), however, there was no documentation indicating the foley had been changed on 6/26/24, or that the physician was consulted for a new foley catheter changing schedule, and no new orders were entered into the medical record. On 6/27/24 the registered nurse (RN) made a visit and included documentation that the next foley catheter change was scheduled for 7/3/24 (30 days between change dates) but had no documentation supporting the reasoning for the delay in foley catheter change. On 7/3/24, the LPN documented the urinary foley catheter change and a “next due” date for change as 7/31/24 (28 days/4 weeks between changes). No documentation regarding consultation with the physician for foley catheter changes was noted. 0n 7/25/24 at 8:20a.m., these findings were reviewed and acknowledged with the Administrator (Staff A), the Clinical Manager (Staff B), and the Director of Operations (Staff C). Staff A and Staff C reviewed the medical record during interview and were unable to identify why the scheduled foley catheter change had not taken place when ordered or find any physician notification or additional orders to change the original 3 week foley catheter change orders in the POC.

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 notified of changes in the patient's condition in 2 (P-3, 13) of 11 records reviewed with therapy services, resulting in a poor clinical outcome, and weight gain in 1 (P-3) of 6 patients with congestive heart failure, from a total sample of 17 records reviewed. Findings include: P-13: The start of care (SOC) date was on 6/21/24, with diagnoses which included chronic obstructive pulmonary disease (COPD), heart failure, and dependence on supplemental oxygen. The Plan of Care (POC) ordered physical therapy (PT) services 1w8 (once weekly times 8 weeks) and occupational therapy (OT) services 1w2, 2w1, and 1 w2. On 7/23/24, record review revealed the Plan of Care (POC) documented, "Notify physician of: O2 (oxygen) Sat (saturation/blood oxygen level) less than ( An OT note dated 7/2/24 documented P-13's O2 level was 90% on 4 liters prior to working with therapy. No O2 readings were evidenced during or post-treatment to ascertain if increased supplemental oxygen was warranted. On 7/3/24, a PT assistant (PTA) note documented P-13's O2 level was 83% on 4 liters prior to working with therapy and 87% pm 4 liters post-therapy. No evidence was found of the PTA increasing O2 to 5 liters as instructed in the PT evaluation noted above. The PTA documented the following when walking the patient 10 feet with 4 ww (wheeled walker): "Upon therapist arrival, patient was standing adjusting O2 machine. Her O2 levels dropped to 71% and required 5 minutes to recover. Later in session she did short distance gait with focus on pacing herself with slower steps, no talking, and breathing deep. Her O2 levels dropped to 82% and was faster to recover after 2 minutes seated break." No physician notification was evidenced in the medical record of the 71% O2 level while on 4 liters of oxygen. Further record review noted OT did reach out to the physician on 7/9/24 concerning O2 levels of 93% pre-therapy and 88% post-therapy. No new orders were noted in the medical record. However, a PTA note dated 7/10/24, documented, "(Patient) went to the hospital on Tuesday, July 9 for SOB (shortness of breath)/low oxygen levels and was admitted to (Hospital). I talked to her today and she is unsure of discharge plan at this point. I will notify (Agency) office." The above findings were reviewed and acknowledged by the Administrator (Staff A) and Director of Operations (Staff C) during an interview on 7/25/24 at 11:15 AM. Both were queried what the Agency expectations would be concerning the findings above. Staff C noted the PT should have notified the physician during the initial PT evaluation when O2 levels dropped to 71% while on 4 liters for a likely ER evaluation. Staff A noted the patient was still very high risk for hypoxia during the PTA note dated 7/3/24 and should have notified the physician for potential treatment orders or ER evaluation. The Agency failed to ensure the patient's oxygen needs were met and failed to notify the physician as ordered in the POC when O2 levels fall below 90%, resulting in delayed physician input/guidance and subsequent hospitalization on 7/9/24 through 7/11/24. **Agency Policy: "Physician’s Plan of Treatment/Change Orders," (Undated). The policy states, "With a change in patient condition, the Agency will notify the attending physician and the physician(s) associated with the relevant aspects of the plan of care, and this shall be documented in the patient chart.” P-3: The Start of Care (SOC) was dated 6/6/24. The Plan of Care (POC) identified diagnoses of Pulmonary Fibrosis, Hypertensive Heart Disease and Congestive Heart Failure. During record review on 7/23/24, it was noted that the POC ordered Skilled Nursing (SN) at a frequency of 1w1, 2w2, 1w1. The POC contained an intervention stating, “Heart Failure Diagnosis: Instruct Pt (Patient)/Caregiver to weight daily and to report variations of 2 lb /24 hours or 5 lb / 7 days to MD...” The comprehensive assessment dated 6/6/24 documented a stated weight of 252. On 6/14/24, the SN documented a weight of 260, an 8-pound weight gain from the comprehensive assessment dated 6/6/24, which was 8 days prior. Under the section “Coordination Plan” the SN documented, “Physician Contacted Re: N/A”. The SN failed to notify the physician of an 8-pound weight gain over 8 days. On 6/28/24, the SN discharge summary stated, “Weight 300.2 … Comments: Weight is up ~ 35 lbs since pt last allowed SN to weigh her (6/19/24). LE edema improved. Lung sounds w/o (without) crackles. Pt (patient) states increase is r/t (related to) muscle mass from working with PT (Physical Therapy) /OT (Occupational Therapy) and being more mobile.” Under the section “Coordination Plan” the SN documented, “Physician Contacted Re: Medication refills”. The SN failed to notify the physician of an ~35-pound weight gain over 9 days and discharged the patient from nursing services but continued to receive PT/OT services. Furthermore, the POC noted a reportable parameter stating, “O2 Sat less than ( These findings were reviewed with and acknowledged by the Staff A (Administrator) and Staff C (Director of Operations) during an interview on 7/24/24 at 2:40 pm. **Agency Policy: "Physician’s Plan of Treatment/Change Orders," (Undated). The policy states, "With a change in patient condition, the Agency will notify the attending physician and the physician(s) associated with the relevant aspects of the plan of care, and this shall be documented in the patient chart.” P-3: The Start of Care (SOC) was dated 6/6/24. The Plan of Care (POC) identified diagnoses of Pulmonary Fibrosis, Hypertensive Heart Disease and Congestive Heart Failure. During record review on 7/23/24, it was noted that the POC ordered Skilled Nursing (SN) at a frequency of 1w1, 2w2, 1w1. The POC contained an intervention stating, “Heart Failure Diagnosis: Instruct Pt (Patient)/Caregiver to weight daily and to report variations of 2 lb /24 hours or 5 lb / 7 days to MD...” The comprehensive assessment dated 6/6/24 documented a stated weight of 252. On 6/14/24, the SN documented a weight of 260, an 8-pound weight gain from the comprehensive assessment dated 6/6/24, which was 8 days prior. Under the section “Coordination Plan” the SN documented, “Physician Contacted Re: N/A”. The SN failed to notify the physician of an 8-pound weight gain over 8 days. On 6/28/24, the SN discharge summary stated, “Weight 300.2 … Comments: Weight is up ~ 35 lbs since pt last allowed SN to weigh her (6/19/24). LE edema improved. Lung sounds w/o (without) crackles. Pt (patient) states increase is r/t (related to) muscle mass from working with PT (Physical Therapy) /OT (Occupational Therapy) and being more mobile.” Under the section “Coordination Plan” the SN documented, “Physician Contacted Re: Medication refills”. The SN failed to notify the physician of an ~35-pound weight gain over 9 days and discharged the patient from nursing services but continued to receive PT/OT services. Furthermore, the POC noted a reportable parameter stating, “O2 Sat less than ( These findings were reviewed with and acknowledged by the Staff A (Administrator) and Staff C (Director of Operations) during an interview on 7/24/24 at 2:40 pm. P-13: The start of care (SOC) date was on 6/21/24, with diagnoses which included chronic obstructive pulmonary disease (COPD), heart failure, and dependence on supplemental oxygen. The Plan of Care (POC) ordered physical therapy (PT) services 1w8 (once weekly times 8 weeks) and occupational therapy (OT) services 1w2, 2w1, and 1 w2. On 7/23/24, record review revealed the Plan of Care (POC) documented, "Notify physician of: O2 (oxygen) Sat (saturation/blood oxygen level) less than ( An OT note dated 7/2/24 documented P-13's O2 level was 90% on 4 liters prior to working with therapy. No O2 readings were evidenced during or post-treatment to ascertain if increased supplemental oxygen was warranted. On 7/3/24, a PT assistant (PTA) note documented P-13's O2 level was 83% on 4 liters prior to working with therapy and 87% pm 4 liters post-therapy. No evidence was found of the PTA increasing O2 to 5 liters as instructed in the PT evaluation noted above. The PTA documented the following when walking the patient 10 feet with 4 ww (wheeled walker): "Upon therapist arrival, patient was standing adjusting O2 machine. Her O2 levels dropped to 71% and required 5 minutes to recover. Later in session she did short distance gait with focus on pacing herself with slower steps, no talking, and breathing deep. Her O2 levels dropped to 82% and was faster to recover after 2 minutes seated break." No physician notification was evidenced in the medical record of the 71% O2 level while on 4 liters of oxygen. Further record review noted OT did reach out to the physician on 7/9/24 concerning O2 levels of 93% pre-therapy and 88% post-therapy. No new orders were noted in the medical record. However, a PTA note dated 7/10/24, documented, "(Patient) went to the hospital on Tuesday, July 9 for SOB (shortness of breath)/low oxygen levels and was admitted to (Hospital). I talked to her today and she is unsure of discharge plan at this point. I will notify (Agency) office." The above findings were reviewed and acknowledged by the Administrator (Staff A) and Director of Operations (Staff C) during an interview on 7/25/24 at 11:15 AM. Both were queried what the Agency expectations would be concerning the findings above. Staff C noted the PT should have notified the physician during the initial PT evaluation when O2 levels dropped to 71% while on 4 liters for a likely ER evaluation. Staff A noted the patient was still very high risk for hypoxia during the PTA note dated 7/3/24 and should have notified the physician for potential treatment orders or ER evaluation. The Agency failed to ensure the patient's oxygen needs were met and failed to notify the physician as ordered in the POC when O2 levels fall below 90%, resulting in delayed physician input/guidance and subsequent hospitalization on 7/9/24 through 7/11/24.

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to analyze data collected to monitor the effectiveness, safety of services and quality of care and identify opportunities for improvement by the Quality Assessment and Performance Improvement (QAPI) program, resulting in a potential to negatively affect all 1079 patients serviced by the Agency during the past 12 months. Findings include: On 7/24/24 at 4:35 PM., review of the Agency’s QAPI binder found multiple performance and improvement projects (PIP's) with data collection generated by its Kinser EMR (electronic medical records) system. However, no evidence was found within its QAPI program that any of the data collected over the last 3 years was analyzed or discussed to evaluate its effectiveness. Documentation of QAPI staff having any input concerning the data collected was not found in its QAPI program for the last 3 years. These findings were reviewed with and acknowledged by the Administrator (Staff A) and Director of Operations (Staff C) during an interview on 7/24/24 at 4:55 PM. The Agency failed to adhere to its policy referenced below. Agency Policy: "Quality Assurance Performance Improvement (QAPI) Section VI (undated) stated, "The process for collection of data will include a scientific approach for collecting the information and the use of statistical control methods for evaluation and comparisons of findings. The QAPI Committee along with Agency leadership and others involved with patients, including physicians and staff, will participate in evaluating the information collected and improving the process and performance of the Agency.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on observation, record review and interview, the agency failed to follow accepted standards of practice for infection control in 4 (P-2, P-6, P-7, and P-11) of 7 records reviewed with home visits (See G682); failed to analyze data collected used to monitor infection control measures among patients identified within its Quality Assessment and Performance Improvement (QAPI) program and failed to incorporate a means to track and trend staff acquired infections (See G684); and failed to provide documented evidence of infection control education for 7 of 12 sampled staff members including those employed through an arranged contract (See G686) resulting in the potential for increased, untreated infections among the agency's patient and staff population. 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 §484.70 Infection prevention and control.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the agency failed to follow accepted standards of practice for infection control in 4 (P-2, P-6, P-7, and P-11) of 7 records reviewed with home visits, resulting in the potential for transmission of infections and communicable disease. Findings include: P-11: This 75-year-old patient was admitted to home care on 6/10/24 with diagnoses of abdominal wound, pulmonary embolism, and malnutrition. During the home visit on 7/24/24 at 9:00 a.m. the registered nurse was observed obtaining the patient signature on her personal cell phone. The patient used his finger to sign the phone and the nurse placed the phone back into her pocket without sanitizing. The nurse was observed performing wound care. The nurse performed hand hygiene, donned gloves, and removed the soiled dressing. Hand hygiene was again performed, and a second pair of gloves were donned. The nurse was observed cleansing and drying the wound. There were no further glove changes to access the clean supplies to redress the wound. This finding was reviewed and acknowledged by the administrator (Staff A), the clinical manager (Staff B), and the director of operations (Staff C) during an interview on 7/25/24 at 9:40 a.m. Agency policy titled “X.7 Standard Precautions for all Health Care Workers” (undated) was reviewed on 7/25/24. On the first page of the document, it stated, "... Hands must be washed: Before putting on and after removing PPE, including gloves... On the third page of the document, it stated, “4 Patient-care equipment and instruments/devices… If noncritical patient-care equipment… cannot remain in the home, clean and disinfect items before taking them from the home…” Agency policy titled "X.1 OSHA Regulations/Infection Control/Exposure Control Plan" (undated), was reviewed on 7/25/24. On page one of the document, it stated, "Patient infection control procedures include... Frequent handwashing by home health employees: After handling soiled or contaminated materials, including blood, body fluids, or contaminated surfaces... Moving from a contaminated body site to a clean body site during patient care." P-6: This 82-year-old was admitted to agency on 2/10/23 with diagnoses including pressure ulcer to the sacral region; paralysis of lower extremities; and incontinence of bowel/bladder. On 7/23/24 a joint home visit was conducted with the registered nurse (RN) at 9:00 a.m. During the observation, after the RN completed all the tasks associated with the visit, the RN asked the patient for a signature which would complete the visit. The RN gave the patient a cell phone from her (the RN’s) pocket. The RN did not clean or disinfect the cell phone prior to handing the cell phone to the patient. The patient held the cell phone with one hand and signed the cell phone screen using a finger from the other hand, and then handed the cell phone back to the RN. At the point of observation, the RN was queried to whether the cell phone was agency issued or a personal phone. The RN replied that it was a personal cell phone and placed the cell phone back in her pocket without cleaning/disinfecting it first. The RN then departed the home. Upon return to the agency at 10:40 a.m., the above information was reviewed with the Administrator (Staff A). Staff A was queried to agency policy regarding use of personal devices and disinfection procedures. Staff A stated that if the staff member is hired as a “per visit” clinician (versus full time or salaried), they would be asked to provide their own tablet device. Staff A was not able to state the agency policy or process for disinfection of personal cell phones in the patient’s home but instead provided the infection prevention and control policies for review. P-7: This 82-year-old was admitted to agency on 12/18/23 with diagnoses including pressure ulcer of the left and right heels; type 2 Diabetes; and chronic heart failure. On 7/24/24 a joint home visit was conducted with the RN at 12:00 p.m. During the visit, the RN was observed while changing wound dressings to each foot (left and right heels). The following observations were noted during the procedures: Changing the dressing to the right heel: after hand hygiene, the RN donned gloves and removed the old dressing. Using the same contaminated gloves, the RN rummaged through a box containing clean/sterile wound dressing items and retrieved desired items. The RN was observed removing the gloves donning new gloves without first performing hand hygiene. The RN was observed a second time throughout the procedure removing gloves and donning new gloves without first performing hand hygiene. Changing the dressing to the left heel: after donning new gloves, the RN removed the old dressing. After performing hand hygiene and donning a new pair of gloves, the RN cleansed the wound bed and re-dressed the wound. Using the same contaminated gloves, the RN was observed gathering the patient’s glucometer and accessories and performed a blood sugar check procedure to the patient’s finger. Using the same gloves, the RN used a stethoscope, blood pressure cuff, pulse oximeter, and thermometer which had been previously removed from a bag brought in at the start of the visit. Using the same gloves, the RN cleansed the above items with alcohol wipes and returned them to the agency bag. On 7/25/24, these findings were reviewed with Staff A, Staff B, and Staff C during interview at 8:20 a.m. Staff B stated that the RN was most likely nervous during the visit but acknowledged that the procedures as described were not done per agency standards of practice. P-2: The Start of Care (SOC) was dated 10/12/23. The Plan of Care (POC) identified diagnoses of Right Lower Leg Wound, Hypertension and Cerebral Palsy. During the observation home visit on 7/24/24 at 9:30 am the registered nurse (Staff H) was observed obtaining the patient signature for the visit completion on his personal cell phone. The patient used his finger to sign the phone and then Staff H placed the phone back into his pocket without sanitizing. Staff H was questioned after the visit regarding infection control with his phone and stated, “I usually clean my phone before and after the patients signature.” The staff member failed to follow agency policy. This finding was reviewed with and acknowledged by the Staff A (Administrator) and Staff C (Director of Operations) during an interview on 7/24/24 at 2:40 pm and 7/25/24 at 12:25 pm.

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 analyze data collected used to monitor infection control measures among patients identified within its Quality Assessment and Performance Improvement (QAPI) program and failed to incorporate a means to track and trend staff acquired infections, resulting in the potential spread of infections between patient care staff and the agency's 1079 patients serviced by the Agency during the past 12 months. Findings include: On 7/24/24 at 4:35 PM., review of the Agency’s QAPI binder found evidence of infection control data collected by its Kinser EMR (electronic medical records) system. However, no evidence was found within the QAPI program that any of the data collected over the last 3 years concerning infection control was analyzed or discussed among any of the Agency’s staff members. In addition, no evidence was found within its QAPI program of a means to track and trend staff acquired infections to identify areas of infection control breakdown. The above findings were reviewed with and acknowledged by the Administrator during an interview on 7/24/24 at 5:08 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, the agency failed to provide documented evidence of infection control education for 7 of 12 sampled staff members including those employed through an arranged contract which has the potential to negatively impact the safety and well-being of all 1079 patients serviced by the agency in the past 12 months. Findings include: Agency policy titled “X.1 OSHA Regulations/Infection Control/Exposure Control Plan” (undated), was reviewed on 7/25/24. On the second page, it stated “… the Agency will… Educate employees in the infection control program and any subsequent revisions upon employment, when changes occur and at least annually…” On 7/24/24 at 4:10 p.m., an interview was conducted with the Administrator (Staff A) and the Director of Operations (Staff C) regarding infection control (IC) education of staff. During the interview, query was made regarding when staff members received IC education. Staff C stated all staff receive IC training at orientation and annually. Query was also made to where the IC education was documented, and Staff C stated that the education would found be in staff personnel files which were stored in the agency electronic medical record (EMR) system. On 7/25/24, 12 personnel files for varied skilled staff including 7 employed directly by the agency, and 5 employed through arranged contracts were reviewed. During review, it was noted that no orientation IC education and no ongoing annual IC education were found in the first 4 personnel files reviewed. On 7/25/24 at 11:35 a.m., the Clinical Manager (Staff B) was queried to where the IC education for those staff members was. Staff B noted that 3 of those personnel files were contracted employees and stated that the education was expected to be provided by the contracting company. When asked if they had documented evidence of the training provided by the contracting company, Staff B stated that they (the agency) do not. Staff B looked in the EMR for the direct employee IC education and was only able to find one documented annual IC education. Staff B stated that she was hired in April 2023 and since hire, has been sending orientation or annual IC education out to staff in email form and they are supposed to email back or sign a form acknowledging completion of the educational material. Staff B stated that she was not having much success with the process. On 7/25/24 at 11:45 a.m., Staff C directly stated that there had been no signed evidence of IC education for the orientation checklist for new hires or annual IC education for staff until October 2023 when she created a form for staff acknowledgment signature and that annual IC education gets sent out in email form to staff but not all staff acknowledge receipt. No additional information or evidence was provided by Staff C regarding IC education for staff members. Continued review of the 8 remaining personnel files revealed that only 1 of 12 staff members acknowledged orientation and annual IC training, and 4 of the 12 acknowledged IC annual training. These findings were reviewed on 7/25/24 at the time of the finding with Staff A, Staff B, and Staff C.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure physical therapy (PT) responsibly assessed, performed pertinent interventions and communicated urgent patient needs in 1 (P-13) of 11 records reviewed with therapy services, from a total sample of 17 records reviewed, resulting in a poor clinical outcome (see G 704); failed to ensure the clinical record was complete and included detailed skilled nursing notes for 3 (P-1, 3, 11) of 17 records reviewed, resulting in lack of continuity of care and undocumented health concerns (see G 716), and failed to ensure skilled nursing communicated assessment findings with the physician for 1 (P-9) of 17 records reviewed, resulting in the potential for poor patient outcomes (see G718). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR §484.75 Skilled professional services.

Responsibilities of skilled professionals CFR(s): 484.75(b) Standard: Responsibilities of skilled professionals. Skilled professionals must assume responsibility for, but not be restricted to, the following: This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to ensure physical therapy (PT) responsibly assessed, performed pertinent interventions and communicated urgent patient needs in 1 (P-13) of 11 records reviewed with therapy services, from a total sample of 17 records reviewed, resulting in a poor clinical outcome. Findings include: P-13: The start of care (SOC) date was on 6/21/24, with diagnoses which included chronic obstructive pulmonary disease (COPD), heart failure, and dependence on supplemental oxygen. The Plan of Care (POC) ordered physical therapy (PT) services 1w8 (once weekly times 8 weeks) and occupational therapy (OT) services 1w2, 2w1, and 1 w2. On 7/23/24, record review revealed the Plan of Care (POC) documented, "Notify physician of: O2 (oxygen) Sat (saturation/blood oxygen level) less than (<) 90%." Further review of the physical therapy (PT) evaluation for P-13 performed by Staff I on 6/24/24, documented the following: "Pt (patient) is a 69-year-old female who reports she was at her scheduled pulmonologist appt. where her doctor sent her directly to the ER as they could not get her O2 above 70's on 5 liters of O2. Pt was then hospitalized from 6/13-6/18 (2024) and then sent home. Pt is on 4 liters of O2 at all times and directed to raise it to 5 liters when up." PT/Staff I also documented the following findings from the 6/24/24 evaluation, "Pt walking very slow and O2 dropped to 71% (normal is 95%-100%, with supplemental oxygen given for O2 levels below 88%) on 4 liters of O2 and needing approximately 4 minutes to get back up to 90%." No O2 treatments/interventions were found within P-13's POC. No documentation was found indicating Staff I had increased the O2 to 5 liters when P-13 was up. No physician notification was evidenced in the medical record regarding the O2 reading of 71% while on 4 liters of oxygen. The PT/Staff I failed to uphold responsibly the job duties outlined in Agency policy referenced below. Agency Policy: "Physical Therapist" Section V.6 (undated) stated, "Provides skilled physical therapy in accordance with the physician's plan of care... Observes, records and reports the patient's reaction to treatment and any change in the patient's condition to the physician..." On 7/3/24, a PT assistant (PTA) note documented P-13's O2 level was 83% on 4 liters prior to working with therapy and 87% pm 4 liters post-therapy. No evidence was found of the PTA increasing O2 to 5 liters as instructed in the PT evaluation noted above. The PTA documented the following when walking the patient 10 feet with 4 ww (wheeled walker): "Upon therapist arrival, patient was standing adjusting O2 machine. Her O2 levels dropped to 71% and required 5 minutes to recover. Later in session she did short distance gait with focus on pacing herself with slower steps, no talking, and breathing deep. Her O2 levels dropped to 82% and was faster to recover after 2 minutes seated break." No physician notification was evidenced in the medical record of the 71% O2 level while on 4 liters of oxygen. No attempt to increase O2 administration to 5 Liters when up was found in the medical record. No evidence was found of any PT staff reviewing and noticing P-13 had no O2 treatments/interventions 12 days after the SOC. The above findings were reviewed and acknowledged by the Administrator (Staff A) and Director of Operations (Staff C) during an interview on 7/25/24 at 11:15 AM. Both were queried what the Agency expectations would be concerning the findings above. Staff C noted the PT should have notified the physician during the initial PT evaluation when O2 levels dropped to 71% while on 4 liters for a likely ER evaluation. Staff A noted the patient was still very high risk for hypoxia during the PTA note dated 7/3/24 and should have notified the physician for potential treatment orders or ER evaluation.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record was complete and included detailed notes for 3 (P-1, 3, 11) of 17 records reviewed, resulting in lack of continuity of care and undocumented health concerns. Findings include: Policy-Wound requirements: Wound care worksheet, wound documentation for all clinical staff (dated 2023). Documentation should always include measurement of the area of the actual wound in centimeters: length x width x depth. These measurements should be taken at each visit. P-11: This 75-year-old patient was admitted to home care on 6/10/24 with diagnoses of abdominal wound, pulmonary embolism, and malnutrition. During record review on 7/23/24, it was noted that the plan of care ordered skilled nursing three times a week for 8 weeks on Monday, Wednesday, and Friday for wound care. The start of care assessment, dated 6/10/24, documented the wound as 12 cm x 9.5 cm and failed to include a depth. There was no evidence of a skilled nursing visit on Wednesday, 6/12/24, and the visit on 6/13/24 stated “wounds not addressed.” The skilled nursing visits from 7/1/24 and 7/10/24 failed to include wound measurements. This finding was reviewed and acknowledged by the administrator (Staff A), the clinical manager (Staff B), and the director of operations (Staff C) during an interview on 7/25/24 at 9:40 a.m. P-1: The Start of Care (SOC) was dated 6/11/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure and End Stage Renal Disease. During record review on 7/22/24, it was noted that the POC ordered Physical Therapy (PT) at a frequency of 1w7 (1 time a week for 7 weeks). On 7/1/24, the Physical Therapy Assistant (PTA) documented, “No falls. No medication changes. Minimal pain. Wounds are limiting ability today… Patient continues (to) show signs of progression with leg wounds and obesity limiting patient ability.” Additionally, under the “Care Coordination” section it was blank on conferencing with anyone. On 7/9/24, the PT completed a discharge summary and stated, “Area on R LE (Right Lower Extremity) and would not let PT see this as pt’s (patients) wife just changed the dressing. Pt reports he doesn’t need nursing when offered b/c (because) he has dealt with this many times before.” Staff A was questioned during an interview on 7/25/24 at 12:25 pm and stated, The PTA should have coordinated with the PT and notified the PCP of the wounds.” P-3: The Start of Care (SOC) was dated 6/6/24. The Plan of Care (POC) identified diagnoses of Pulmonary Fibrosis, Hypertensive Heart Disease and Congestive Heart Failure. During record review on 7/23/24, it was noted that the POC ordered Skilled Nursing (SN) at a frequency of 1w1, 2w2, 1w1. Additionally, the POC contained an intervention stating, “Heart Failure Diagnosis: Instruct Pt (Patient)/Caregiver to weight daily and to report variations of 2 lb /24 hours or 5 lb / 7 days to MD. Instruct pt to log wights daily, clinicians to monitor. If unable to weigh, measure BLE edema and report changes of 2 cm or greater to the MD. Instruct pt to log measurements daily, clinicians to monitor.” On 6/10/24, the SN documented, “Weight: blank. Edema bilat LE 4+.” On 6/21/24, the SN documented, “Weight: blank. Edema: LLE 1+, RLE 2+.” The SN failed to follow the POC and measure edema if unable to weigh. These findings were reviewed with and acknowledged by the Staff A (Administrator) and Staff C (Director of Operations) during an interview on 7/24/24 at 2:40 pm and 7/25/24 at 12:25 pm.

Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure skilled nursing communicated assessment findings with the physician for 1 (P-9) of 17 records reviewed, resulting in the potential for poor patient outcomes. Findings include: P-9: This 77-year-old patient was admitted to home care on 4/20/24 with diagnoses of type 2 diabetes, hypertensive heart and chronic kidney disease, and congestive heart failure. During record review on 7/22/24, it was noted that the plan of care failed to include parameters for blood glucose monitoring. During the skilled nursing visit on 5/9/24, the registered nurse documented a non-fasting blood glucose level of 324. The record failed to indicate if the patient had taken insulin as prescribed in the plan of care, if the level had been rechecked, or if the physician was notified. This finding was reviewed and acknowledged by the administrator (Staff A), the clinical manager (Staff B), and the director of operations (Staff C) during an interview on 7/25/24 at 9:40 a.m.

Referral laboratory must be certified CFR(s): 484.100(c)(2) If the HHA refers specimens for laboratory testing, the referral laboratory must be certified in the appropriate specialties and subspecialties of services in accordance with the applicable requirements of part 493 of this chapter. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the agency failed to secure Clinical Laboratory Improvement Amendments (CLIA) waivers for referral specimen laboratory testing as required while engaging in offsite testing. Staff A was questioned on 7/24/24 at 2:40 pm regarding CLIA documentation for laboratories that specimens are dropped off at and stated, “We have never asked for their CLIA.” The agency failed to maintain records for the referral laboratory’s CLIA certification.

Coordinate patient care CFR(s): 484.105(c)(2) Coordinating patient care, This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure clinical manager oversight of coordinating patient care services and personnel for 1 (P-10) of 17 records reviewed, resulting in the potential for inappropriate care and unmet care needs. Findings include: P-10: This 75-year-old patient was admitted to home care on 6/28/24 with diagnoses of metastatic Mullein adenocarcinoma and paraneoplastic neuromyopathy. During record review on 7/23/24, it was noted that the plan of care ordered skilled nursing, physical therapy (PT), and occupational therapy (OT). PT was ordered twice a week for three weeks, then once a week for four weeks. PT evaluated the patient on 7/10/24 and had a missed visit on 7/13/24. PTA (physical therapy assistant) visits for 7/15/24 and 7/17/24 were listed in the record as “not started.” This finding was reviewed with the administrator (Staff A), the clinical manager (Staff B), and the director of operations (Staff C) during an interview on 7/25/24 at 9:40 a.m. Staff C stated the agency is unsure if the PTA has been to see the patient because “nothing has been started yet.” She stated they will check the delinquent visit list and contact the therapist.

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 in 1 (P-5) of 17 sample records reviewed resulting in omission of care by therapy services and potential decline in function of this patient. Findings include: P-5: This 69-year-old was admitted to agency on 7/8/24 with diagnoses including acute pyelonephritis (kidney infection); pulmonary fibrosis (disease which scars the lungs and causes difficulty breathing); and Chronic Obstructive Pulmonary Disease (progressive lung disease causing breathing difficulties). The medical record was reviewed on 7/22/24. During review, it was noted that the physician referral for home health services dated 7/2/24 included orders for nursing services, physical therapy (PT), and occupational therapy (OT). The start of care was completed by the nurse on 7/8/24 and included documentation of the referral for PT and OT services. No PT or OT services were provided or scheduled 14 days into service (time of medical record review). There was no documentation that noted patient or caregiver need for delay or refusal of PT and OT services. There were no new physician orders to discontinue evaluation by PT or OT services. It was unclear in the medical record why PT and OT evaluations were not scheduled or provided. During interview on 7/25/24 at 8:20 a.m. with the Administrator (Staff A) and the Clinical Manager (Staff B), Staff A was queried to why PT and OT evaluations were not yet provided. After viewing the record, Staff A was unable to provide evidence to why those services had not been provided and stated, “we will have to check on this and see what happened.” Staff B had no information to add.

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 contained completed assessments and visit notes for 5 (P-1, 2, 3, 4, 10) of 17 records reviewed, resulting in a lack of information for the physician and all agency staff caring for the patient. Findings include: During the entrance interview on 7/22/24 at 10:45 a.m., the administrator (Staff A) stated visit notes are to be completed within 24 hours. The agency was asked to provide a policy and produced a “K-mail” that was sent to all agency staff on 6/21/24 at 9:19 a.m. from the director of operations (Staff C) that stated, “all documentation is due within 24 hours of the patient visit.” P-10: This 75-year-old patient was admitted to home care on 6/28/24 with diagnoses of metastatic Mullein adenocarcinoma and paraneoplastic neuromyopathy. The plan of care orders skilled nursing, physical therapy (PT), and occupational therapy (OT). PT was ordered twice a week for three weeks, then once a week for four weeks. During record review on 7/23/24, it was noted that PT evaluated the patient on 7/10/24 and physical therapy assistant visit notes from 7/15/24 and 7/17/24 were listed in the record as “not started.” This finding was reviewed and acknowledged by the administrator (Staff A), the clinical manager (Staff B), and the director of operations (Staff C) during an interview on 7/25/24 at 9:40 a.m. P-1: The Start of Care (SOC) was dated 6/11/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure and End Stage Renal Disease. During record review on 7/22/24, it was noted that the POC stated, “Notify physician of: … Fasting blood sugar greater than (>) 250 or less than ( P-2: The Start of Care (SOC) was dated 10/12/23. The Plan of Care (POC) identified diagnoses of Right Lower Leg Wound, Hypertension and Cerebral Palsy. During record review on 7/23/24, was noted that the Registered Nurse (RN) completed a comprehensive assessment on 10/12/23 and a recertification on 6/3/24. The section under “Skilled Intervention” titled “Assessment/Instruction/Performance” contained the same exact wording for both the start of care comprehensive assessment and recertification visit. Additionally, the plan of care ordered Skilled Nursing visits at a frequency of 3w8 (3 visits a week for 8 weeks) for wound care. There have been no wound measurements completed since 5/10/24, but weekly photos have been completed. The agency document titled, “Wound Care Worksheet Wound Documentation For All Clinical Staff 2023” stated, “Documentation should always include measurement of the area of the actual wound in centimeters: Length x width x depth. These measurements should be taken at Each Visit.” The agency failed to maintain a current and accurate clinical record. P-3: The Start of Care (SOC) was dated 6/6/24. The Plan of Care (POC) identified diagnoses of Pulmonary Fibrosis, Hypertensive Heart Disease and Congestive Heart Failure. During record review on 7/23/24, it was noted that the POC ordered Skilled Nursing (SN) at a frequency of 1w1, 2w2, 1w1. Additionally, the POC contained an intervention stating, “Heart Failure Diagnosis: Instruct Pt (Patient)/Caregiver to weight daily and to report variations of 2 lb /24 hours or 5 lb / 7 days to MD. Instruct pt to log wights daily, clinicians to monitor. If unable to weigh, measure BLE edema and report changes of 2 cm or greater to the MD. Instruct pt to log measurements daily, clinicians to monitor.” The comprehensive assessment dated 6/6/24 documented a stated weight of 252. 3 of the 6 completed SN visits contained no weight documentation: 6/10/24, 6/19/24 and 6/21/24. Furthermore, on 7/3/24 the Physical Therapy Assistant (PTA) documented, “O2 Sat: 92 Room Air” under the vital sign area, and then documented, “fatigues easily and SOB (Short of breath) with O2 at 2 liters under the section titled “Impact of Exercise(s) on Functional Performance / Patient Responses to Treatment”. The Physical Therapist discharged the patient on 7/17/24 and documented, “O2 Sat: 98 Room Air” under the vital sign area, and then documented, “Respiratory Therapies: Check all that apply. C1. Oxygen therapy and C2. Continuous.” Additionally, it was noted that the POC stated, “Notify physician of: … Fasting blood sugar greater than (>) 250 or less than ( P-4: The Start of Care (SOC) was dated 6/14/24. The Plan of Care (POC) identified diagnoses of Sepsis, Diabetes Type 2 and Left Foot Ulcer. During record review on 7/25/24, it was noted that that the POC ordered SN at a frequency of 1w2, 3w7, 1w1. The SN visit scheduled for 7/19/24 states, “Not Started.” During the entrance interview on 7/22/24 at 10:45 a.m., the administrator (Staff A) stated visit notes are to be completed within 24 hours. The SN failed to follow agency documentation expectations. These findings were reviewed with and acknowledged by the Staff A (Administrator) and Staff C (Director of Operations) during an interview on 7/24/24 at 2:40 pm and 7/25/24 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 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 4 (P-1, 3, 6, 9) of 5 closed records; and failed to ensure the transfer summary was complete, provided the patient's health status at the time of transfer, and sent to the physician/receiving facility within 2 business days of the patient's transfer in 1 (P-16) of 2 records reviewed with transfers, out of a total sample of 17 records, resulting in the physician/receiving facility not having knowledge of the patient's health status at the time of discharge/transfer, and the potential for unidentified continuing health care concerns and unmet care needs. Findings include: P-16: The SOC date was on 9/11/23, with diagnoses which included chronic pain, urinary tract infection (UTI), and diabetes-type 2. On 7/24/24, record review noted the patient was transferred to the hospital on 11/3/23. Review of the transfer summary dated 11/3/23, performed by skilled nursing (SN/Staff H) failed to provide comprehensive medical history of P-16 with clinical data, treatments furnished and outcomes in meeting goals. For example, no documentation was found in the transfer summary of the patient's diabetes or how EMS was emergently called while SN was providing a home visit with a blood sugar reading of 36 mg/dL 15 minutes after SN interventions were performed. In addition to the noted diagnoses above, P-16 also had active diagnoses of hypertension, chronic obstructive pulmonary disorder, atrial fibrillation, obstructive sleep apnea, congestive heart failure, gout, and diabetic neuropathy. None of these listed diagnoses were included in the transfer summary. Further, P-16 was being treated for a sacral pressure ulcer that needed Iodoform packing strip into wound three times weekly. This detailed information was not found in the transfer summary for physician review to order treatments/services to optimize P-16's clinical needs at the time of transfer. These findings were reviewed and acknowledged by the Administrator (Staff A) and Director of Operations (Staff C) during an interview on 7/25/24 at 11:40 AM. Both agreed this did not meet Agency expectation and failed to adhere to its policy referenced below. In addition, Staff A was queried when the transfer summary was sent the physician. Staff A after looking into the medical record replied, December 6th (33 days after transfer). This did not comply with the Agency's policy referenced below. Agency Policy: "Transfer/Transfer OASIS" Section III.10 (undated) stated, "When a patient is transferred to another facility or level of care, relevant information regarding the patient's condition and care requirements will be provided in writing (and verbally, if possible) to the transferring facility." P-9: This 77-year-old patient was admitted to home care on 4/20/24 with diagnoses of type 2 diabetes, hypertensive heart and chronic kidney disease, and congestive heart failure. During record review on 7/22/24, it was noted that the patient was discharged from agency services on 5/16/24. There was no evidence that a detailed discharge summary report was sent to the physician within 5 days of the patient’s discharge. This finding was reviewed and acknowledged by the administrator (Staff A), the clinical manager (Staff B), and the director of operations (Staff C) during an interview on 7/25/24 at 9:40 a.m. P-1: The Start of Care (SOC) was dated 6/11/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure and End Stage Renal Disease. During record review on 7/22/24, it was noted that the Skilled Nursing (SN) discharge dated 6/28/24 stated, "Care Summary (care given, progress, regress including therapies): Blank." The discharge summary failed to detail the course of care provided, responses to treatment, any potential continuing needs, and failed to document the patient's health status at the time of discharge in measurable terms. P-3: The Start of Care (SOC) was dated 6/6/24. The Plan of Care (POC) identified diagnoses of Pulmonary Fibrosis, Hypertensive Heart Disease and Congestive Heart Failure. During record review on 7/23/24, it was noted that the SN discharge dated 6/28/24 stated, "Care Summary (care given, progress, regress including therapies): SN visits for O2, medication and vital sign assessment, monitoring and education." The Occupational Therapist completed a discharge summary on 7/9/24 stating, “Care Summary (care given, progress, regress including therapies): Blank." The Physical Therapist discharged the patient on 7/17/24 which documented, “Care Summary (care given, progress, regress including therapies): LE (Lower Extremity) strengthening, gait training.” The discharge summaries failed to detail the course of care provided, responses to treatment, any potential continuing needs, and failed to document the patient's health status at the time of discharge in measurable terms. Additionally, 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 reviewed with and acknowledged by the Staff A (Administrator) and Staff C (Director of Operations) during an interview on 7/24/24 at 2:40 pm and 7/25/24 at 12:25 pm.

Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure that clinical records were safeguarded against unauthorized use, resulting in the potential compromise of protected health information for all patients served by this agency. Findings include: Policy-XI.15 Security and Privacy for use of Portable Electronic Devices (no date). This policy describes the required security guidelines for devices utilized to access electronic protected health information (ePHI). All precautions must be taken when utilizing devices to access ePHI. Staff are only allowed to utilize devices to access ePHI at private locations, with secured internet connections. Devices are not to be used in any public areas. Policy-IV.26 Personal Cell Phone Use (no date). Personal use of a cell phone is prohibited while performing work-related tasks. This includes personal use by field staff while in a patient’s home. P-11: This 75-year-old patient was admitted to home care on 6/10/24 with diagnoses of abdominal wound, pulmonary embolism, and malnutrition. During the home visit on 7/24/24 at 9:00 a.m. the registered nurse was observed capturing a photo of the patient’s wound on her personal cell phone. The administrator (Staff A) was queried on the use of personal devices to obtain images of patient wounds during an interview on 7/24/24 at 3:15 p.m. Staff A stated regular (full or part time) staff are provided with agency tablets and paid per visit staff are encouraged to purchase their own tablets. Staff A stated that clinical staff who utilize their personal devices are required to have password protection on their devices and are instructed to delete the images after uploading them to the system. Staff A demonstrated the procedure for uploading an image onto the electronic medical record. Staff A acknowledged staff is utilizing the camera function on the cell phone and the image is stored on the employee's personal device. The director of operations (Staff C) was queried on the lack of agency policy relating to staff utilizing personal cell phone to capture ePHI and security during an interview on 7/25/24 at 12:20 p.m. Staff C acknowledged the expectation is communicated to the employee and is not contained in the personal cell phone use policy.

Personnel qualifications CFR(s): 484.115 Condition of participation: Personnel qualifications. HHA staff are required to meet the following standards: This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure that 1 of 8 Certified Occupational Therapy Assistant (COTA), who was granted clinical privileges, maintained an active and current license to provide care, resulting in the potential for unsafe care and unmet care needs for the 18 patients serviced by this employee. 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 §484.115 Personnel qualifications.

Occupational Therapy Assistant CFR(s): 484.115(g) Standard: Occupational therapy assistant. A person who- (1) Meets all of the following: (i) Is licensed or otherwise regulated, if applicable, as an occupational therapy assistant by the state in which practicing, unless licensure does not apply. (ii) Graduated after successful completion of an occupational therapy assistant education program accredited by the Accreditation Council for Occupational Therapy Education, (ACOTE) of the American Occupational Therapy Association, Inc. (AOTA) or its successor organizations. (iii) Is eligible to take or successfully completed the entry-level certification examination for occupational therapy assistants developed and administered by the National Board for Certification in Occupational Therapy, Inc. (NBCOT). (2) On or before December 31, 2009- (i) Is licensed or otherwise regulated as an occupational therapy assistant, if applicable, by the state in which practicing; or any qualifications defined by the state in which practicing, unless licensure does not apply; or (ii) Must meet both of the following: (A) Completed certification requirements to practice as an occupational therapy assistant established by a credentialing organization approved by the American Occupational Therapy Association. (B) After January 1, 2010, meets the requirements in paragraph (f)(1) of this section. (3) After December 31, 1977 and on or before December 31, 2007- (i) Completed certification requirements to practice as an occupational therapy assistant established by a credentialing organization approved by the American Occupational Therapy Association; or (ii) Completed the requirements to practice as an occupational therapy assistant applicable in the state in which practicing. (4) On or before December 31, 1977- (i) Had 2 years of appropriate experience as an occupational therapy assistant; and (ii) Had achieved a satisfactory grade on an occupational therapy assistant proficiency examination conducted, approved, or sponsored by the U.S. Public Health Service. (5) If educated outside the United States, on or after January 1, 2008- (i) Graduated after successful completion of an occupational therapy assistant education program that is accredited as substantially equivalent to occupational therapist assistant entry level education in the United States by- (A) The Accreditation Council for Occupational Therapy Education (ACOTE). (B) Its successor organizations. (C) The World Federation of Occupational Therapists. (D) By a credentialing body approved by the American Occupational Therapy Association; and (E) Successfully completed the entry level certification examination for occupational therapy assistants developed and administered by the National Board for Certification in Occupational Therapy, Inc. (NBCOT). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure that 1 of 8 Certified Occupational Therapy Assistants (COTA), who was granted clinical privileges, maintained an active and current license to provide care, resulting in the potential for unsafe care and unmet care needs for the 18 patients serviced by this employee. Findings include: Policy-V.9 Occupational Therapy Assistant (job description). Personal/Professional Development: Maintains professional licensure/certification. On 7/25/24 at 12:30 p.m., a copy of license of COTA (Staff D) was requested from clinical manager (Staff B). At 12:40 p.m., Staff B produced a copy of Staff D’s State of Michigan COTA license with an expiration date of 5/31/22. An inquiry with the Bureau of Licensing and Regulatory Affairs indicated Staff D’s professional license had lapsed. Staff B was tasked to run a report through the electronic medical record to include Staff D’s patient encounters from 6/1/22 to present. No visits were found from 6/1/22 through 7/31/23. From August 2023 to December 2023, Staff D made 34 patient visits to 18 patients. There were no visits made after 12/29/23. From the list of 18 patients serviced by Staff D, an occupational therapy focused evaluation was completed on 9 charts. Of these 9 patients, 5 included a supervisory visit note from the occupational therapist indicating “satisfactory or excellent” comments of Staff D. There was no evidence of unsafe care. At 2:30 p.m., an interview was conducted with the administrator (Staff A) and the director of operations (Staff C), who indicated that Staff D was hired on 4/15/21 as a receptionist/intake personnel for the ABA (applied behavior analysis) program of another division owned by the agency. Staff D reported to the co-executive director (Staff E) of Rebound (a therapy division also owned by the agency). Staff C stated the Rebound office manager (Staff F), “is responsible for uploading and keeping records updated.” Staff A was queried as who authorized this intake employee (Staff D) to assign clinical care. Staff A stated the Occupational Therapy (OT) director (Staff G) assigned Staff D as a COTA on 8/31/23. Staff A was interviewed at 2:46 p.m. to determine who was responsible for clinical oversight and ensuring staff has current licensure. At 3:13 p.m., Staff A acknowledged that it is the responsibility of the administrator (Staff A) to ensure that all clinicians have active and current licensure.

An unannounced on-site complaint investigation MI00105303 was conducted by the Michigan Department of Licensing and Regulatory Affairs on 3/13/24 at: AdvisaCare Solutions of Kalamazoo 5401 Portage Rd., Suite 1 Portage, MI 49002 For this survey: 10 records were reviewed without home visits. 2 of 3 allegations were substantiated. At the conclusion of the survey the agency was found to be out of compliance with standard level deficiencies for the conditions of participation for home health agencies at: 42 CFR Part 484.

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 visit frequencies were provided only as ordered by the physician for 2 (P-2 and 3) of 10 records reviewed, resulting in the potential for the provision of inappropriate care and services. Findings include: **Agency Policy: "III.6 Physician’s Plan of Treatment/Change Orders," (Undated). The policy states, "The plan of treatment shall include but not limited to: Specific discipline, frequency and duration of services.” P-2: The Start of Care (SOC) was dated 11/25/23. The Plan of Care (POC) identified diagnoses of Acute and Chronic Respiratory Failure and Bronchiectasis. During record review on 3/13/24, it was noted the POC dated 11/25/23 specified a Skilled Nurse (SN) frequency of 1w5 (One visit per week for 5 weeks), 2w1. The SN failed to provide the services and frequency as ordered on the plan of care for the week of 12/25/23 through 12/31/23. No physician order or notification was documented. The agency failed to provide the services and frequency as ordered by the physician. P-3: The Start of Care (SOC) was dated 10/15/23. The Plan of Care (POC) identified diagnoses of Organ Transplant, Lymphedema, and Chronic Respiratory Failure. During record review on 3/13/24, it was noted the POC dated 12/15/23 specified a SN frequency of 1w1, 2w8. The SN completed a routine visit on 1/29/24, then no further visits were completed. No physician order or notification was documented. The agency failed to provide the services and frequency as ordered by the physician. These findings were reviewed with and acknowledged by the Staff-A (Administrator) and Staff-B (Clinical Manager) during an interview on 3/13/24 at 2:45 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 current health status at the time of discharge, progress toward goals in 1 (P-1) of 1 closed record, from a total of 10 records reviewed, resulting in the potential for unidentified continuing health care concerns and unmet care needs. Findings include: **Agency Policy: "III.11 Discharge Planning, Discharge Summary and Discharge OASIS," (Undated). The policy states, "The discharge summary will include but is not limited to: Reason for admission, reason for discharge, status of problems throughout the course of care, types of care/services provided, the patient’s overall status at time of discharge.” P-1: The Start of Care (SOC) was dated 1/20/24. The Plan of Care (POC) identified diagnoses of Stage 2 Pressure Ulcer Right Buttock, Cellulitis of Left Upper Limb, and Diabetes Type 2. During record review on 3/13/24, it was noted that an OASIS-E Discharge (Non-Billable) was digitally signed by RN#1 on 1/29/24, the same day Complainant#1 completed a routine visit. Adm#1 was questioned on 3/13/24 at 2:30 pm regarding the discharge and stated, “We had a nurse lined up to provide services. RN#1 reached out to the emergency contact and provider with messages left. ClinicalMgr#1 left messages with the patient as well.” Adm#1 and ClinicalMgr#1 were questioned on 3/13/24 at 2:30 pm regarding documentation of attempted contact and stated, “There is no documentation of messages left by anyone in the EMR (Electronic Medical Record).” Additionally, it was noted that the Skilled Nursing discharge dated 1/29/24 stated, "Care Summary (care given, progress, regress including therapies): Skilled Nursing Wound care, education, assessment.” The discharge summary failed to detail the course of care provided, responses to treatment, any potential continuing needs, and failed to document the patient's health status at the time of discharge in measurable terms. These findings were reviewed with and acknowledged by the Staff-A (Administrator) and Staff-B (Clinical Manager) during an interview on 3/13/24 at 2:45 pm.

The following standard level deficiencies were identified during a Medicare authorized Complaint investigation (22748) conducted by the Michigan Department of Licensing and Regulatory Affairs on 6/29/23 at: AdvisaCare solutions of Kalamazoo 5401 Portage Rd., Suite 1 Portage, MI 49002 This agency had no additional functional work sites, however, did report having 3 drop sites located at: 1690 Watertower Place, Suite500 East Lansing, MI 48823 Phone: 517-336-0106 Fax: 517-336-0468 4234 Cascade Rd. SE Grand Rapids, MI 49546 Phone: 616-942-5695 Fax: 269-593-6003 1906 Holton Rd., Suite A Muskegon, MI 49445 Phone: 231-719-0101 Fax: 231-719-0101 Upon completion of the investigation, the following was determined: Allegation #1: It was alleged the facility discriminated against the patient - unsubstantiated. Allegation #2: It was alleged the facility failed to prepare/administer the medication properly - unsubstantiated. Allegation #3: It was alleged the facility failed to use proper infection control practices when caring for the patient's PICC line - unsubstantiated. Allegation #4: It was alleged the facility failed to ensure staff were properly trained to do their job and instruct patients - Substantiated. Allegation #5: It was alleged the facility failed to show up for a scheduled appointment to provide care to the patient - Substantiated. Allegation #6: It was alleged the facility was rude, threatening, and made false reports about the patient - Unsubstantiated.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined that the Agency failed to provide care and services, in accordance with the visit frequency, for one (P-1) of one patient who experienced high risk pregnancy with uncontrolled vomiting and dehydration, from a total of two sampled patients reviewed, resulting in the patient not receiving care based on her individualized needs, the potential for worsening of health condition and unmet care needs. Findings include: P-1: On 6/29/23 at 10:00 a.m., during a review of the clinical record, it was noted that the patient was admitted to this agency on 5/7/21 with diagnoses that included Dehydration and Hyperemesis. The referral for home care, dated 4/28/21, ordered Infusion Therapy to be performed. The Physician’s Orders dated 4/28/21 documented a diagnosis of “Current twin pregnancy complicated by Hyperemesis (prolonged vomiting) with PICC (Peripherally inserted central catheter – used to draw blood and administer fluids and medications) line in place” with instructions to flush PICC line daily and change PICC dressings as needed. The Initial Comprehensive Assessment dated 5/7/21, documented Skilled Nursing (SN) services to be provided at a frequency of 3w1, 2w1, 1w5 for infusion therapy. No Plan of Care had been completed at the time of this review. At the time of the record review, it was noted that the Skilled Nurse (RN #1) made 3 scheduled visits to the subject of the complaint’s home on 5/7/21, 5/8/21 and 5/9/21. The record revealed that there were no further visits made by this Agency. On 6/29/23 at 3:23 p.m., an interview was conducted with the Director of Operations (DO #1). When queried about the ending of covered services, DO #1 reported, “We received orders from Coram (Infusion Company) for this patient to receive infusion therapy for emesis and dehydration. We only did 3 visits for this lady. After 3 days, the patient was not happy with the nurse (RN #1). She (patient) was very angry that the nurse didn’t show for the scheduled visit. She (patient) spoke with the person who was our Clinical Manager at the time but wasn’t able to get to an agreement. I spoke with the patient myself and she was very upset about the nurse’s (RN #1) behavior. We didn’t have the correct orders, so RN #1 called the company while with the patient. The patient was really upset about this. I told her the nurse was experienced and she (patient) felt I was taking the nurse’s side. After the call abruptly ended, I called Coram and told them that the patient just basically fired us (AdvisaCare). They (Coram) said they would contact the Physician.” When asked if the Agency had notified the Physician directly that services had been ended, DO #1 responded, “No. We didn’t notify the Physician. We just informed the infusion company.” When asked if the patient refused any further services, DO #1 stated, “No.” DO #1 further acknowledged, “Our Clinical Manager at the time was a Registered Nurse also. We should have sent somebody else out to see the patient if she (patient) wasn’t happy with that nurse (RN #1).” The Agency failed to ensure the needs of the patient were met by providing services as ordered by the Physician. Additionally, the Agency failed to notify the patient’s Physician that services had ended. The complainant’s allegation was substantiated. See CMS 2567.

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the Registered Nurse was competent to perform ordered tasks for one (P-1) of 1 patient who required Infusion Therapy, from a total of two sampled records reviewed, resulting in the potential for ineffective medication administration and decline in physiological functioning. Findings include: P-1: On 6/29/23 at 10:00 a.m., during a review of the subject of the complaint’s clinical record, it was noted that the patient was admitted to this agency on 5/7/21 with diagnoses that included Dehydration and Hyperemesis. The referral for home care, dated 4/28/21, ordered Infusion Therapy to be performed. The Physician’s Orders dated 4/28/21 documented a diagnosis of “Current twin pregnancy complicated by Hyperemesis with PICC (Peripherally inserted central catheter – used to draw blood and administer fluids and medications) line in place” with instructions to flush PICC line daily and change PICC dressings as needed. The “Patient Medication Record” dated 5/7/21 indicated the patient was to receive Ondansetron/Antiemetic via PICC line every 6 to 8 hours for nausea, Promethazine every 6 hours via PICC line; Normal saline flush mix with Promethazine; Heparin flush via PICC line after medication administration; Lactated Ringers via PICC line using IV (intravenous) pump 3 times per week as needed. The Initial Comprehensive Assessment dated 5/7/21, documented Skilled Nursing (SN) services to be provided at a frequency of 3w1, 2w1, 1w5 for infusion therapy. No Plan of Care had been completed at the time of this review. On 6/29/23 at 11:30 a.m., a review of the alleged perpetrator’s (RN #1) employee file was reviewed in order to ascertain training and qualifications. RN #1’s date of hire was 6/20/2018. A document titled “Skills/Experience Checklist” was noted to be a “Self-Assessment” tool. The section titled “Infusion Therapy” documented: Insertion – I need to review; Flushing – Competent to perform without supervision. The sections titled “Review or instruction complete date, Skill demonstration and Demonstrates competency," were to be completed by a Registered Nurse preceptor, however all areas were left blank. The form was void of any signatures. A second Self-Assessment tool dated 2/3/21 was reviewed noted to have been signed by the Registered Nurse (RN #3). All sections were coded as “No instruction needed.” Additionally, all tasks reflected the same date of 2/3/21. The form was signed by both RN #1 and RN #3. On 6/29/23 at 12:10 p.m., during a telephone interview, the Registered Nurse (RN #3) was queried regarding her entries on RN #1’s Self-Assessment tool. During the interview, RN #3 acknowledged being familiar with RN #1 and stated, “I know her because we went to nursing school a while back.” When asked if she (RN #3) observed RN #1 perform any of the tasked on the Self-Assessment tool, RN #3 responded, “No, I’m not a training or preceptor. If help is needed, I just step in. “I didn’t observe her perform any of the tasks.” On 6/29/23 at 12:25 p.m., an interview conducted with the Administrator (Adm #1) regarding RN #1’s Self-assessment tool and reported, “I would expect all areas of the form to be completed to indicate observation of skills demonstration.” On 6/29/23 at 3:23 p.m., during an interview, the Director of Operations (DO #1) reported, "We use the S.A.S.H. technique Saline/Administer Medication/Saline/Heparin) for infusion therapy. We follow the orders given to us by the infusion company." During the review, there was no documented evidence of training in the area of Infusion Therapy or the S.A.S.H. (Saline/Administer Medication/Saline/Heparin) technique, nor was there any evidence that RN #1 had been observed and deemed competent in this area. These findings were reviewed with and acknowledged by DO #1 during the above interview. g

A Medicare authorized unannounced on-site complaint investigation (#96539) was conducted by the Michigan Department of Licensing and Regulatory Affairs on 3/10/23 at: Advisacare Solutions of Kalamazoo 5401 Portage Rd., Suite 1 Portage, MI 49002 The Agency had no additional locations. For this complaint investigation: 3 records without home visits, were reviewed. Based on record review and interview, two of three complaint allegations (#1 and #2) were found to be substantiated with the following condition level deficiency: 42 CFR §484.60: Care Planning, Coordination, Quality of Care. Allegation #3 was unsubstantiated due to lack of sufficient evidence. At the conclusion of the survey, the Agency was found not in compliance with 42 CFR §484 Conditions of Participation for Home Health Agencies.

Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the comprehensive assessment accurately reflected the patient's current health status for 1 (MR #1) record, from a total of 3 sampled records reviewed, resulting in incomplete clinical information and the potential for a poor clinical outcome. Findings include: The subject of the compliant (MR#1), was admitted to the agency on 1/23/23 with diagnoses which included congestive heart failure (CHF), diabetes-type 2, chronic kidney disease, and acute respiratory failure. The referral for home care dated 1/21/23, noted the patient has been an insulin dependent diabetic since 12/29/19, with significantly uncontrolled blood sugars. The referral documented the patient's A1C (test to measure long-term blood sugar averages) was 10.6 (Normal less than 5.7) which equates to a blood sugar average of approximately 250 mg/dl. (Normal is less than 117 mg/dl.). The start of care comprehensive assessment for MR#1 by Skilled Nursing (SN) on 1/23/23 failed to document and implement the significant finding of the patient's A1C of 10.6. Under the "Endocrine" section of the assessment, no history concerning the scope and extent of the patient's diabetic diagnosis was found. This failure contributed to a lack of interventions such as safety parameters in which to report elevated blood sugar levels to the physician. For example, on 2/16/23 the documented blood sugar for the patient was 264 with no notification evidenced in the medical record. The above findings were reviewed and acknowledged by the Agency's Administrator and the Director of Operations on 3/10/23 at 1:45 PM.

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 included physician orders to provide wound care by skilled nursing, and failed to include pertinent interventions with reportable parameters concerning diabetes management in 1 (MR#1) record, from a total of 3 sampled records reviewed (See G 574); and failed to ensure the physician was promptly notified of significant weight gain concerning congestive heart failure, and elevated blood sugar readings in 1 (MR#1) record, from a total of 3 sampled records reviewed (See G 590). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.60: Care Planning, Coordination, and Quality of Care.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Plan of Care (POC) included physician orders which approved wound care provided by skilled nursing and failed to include pertinent interventions with reportable parameters concerning diabetes management in 1 (MR#1) record, from a total of 3 sampled records reviewed, resulting in care being rendered without physician involvement and the potential for poor patient outcomes. Findings include: The subject of the compliant (MR#1), was admitted to the agency on 1/23/23 with diagnoses which included congestive heart failure (CHF), diabetes-type 2, chronic kidney disease, and acute respiratory failure. The referral for home care noted the patient had been hospitalized (1/11/23 to 1/21/23) from exacerbation (worsening) of heart failure due to fluid overload. The medical history was positive for a BKA (below the knee amputation) on 12/29/2019. The physician physical exam on day of hospital discharge (1/21/23) documented no skin breakdown with no wound care treatments needed. However, the patient was taken to the ER on 2/13/23 for evaluation of a BKA pressure ulcer. The patient’s Plan of Care (POC) ordered Skilled Nursing (SN) at a frequency of 2W1 (twice a week for one week), followed by 1W7. SN performed its ordered weekly visit on 2/16/23 after the ER visit and documented a newly developed pressure ulcer at the BKA site (length 2cm., width 2cm., and depth 0 cm.) with scant drainage without odor. Wound care interventions and documentation, with weekly accompanying comparison photos were noted by SN on the following dates: 2/16/23, 2/22/23, 3/1/23. On 3/1/23 for example, SN documented the following wound care intervention: "Treatment: wash wound with soap and water, apply Iodosorb (wound care ointment) to the packing strip and pack into wound, cover your wound with gauze pad, change dressing daily." No physician order was found in the medical record which directed SN how and when to perform this wound care treatment. Additionally, the POC had no blood sugar (BS) parameters for physician notification concerning elevated results. For example, SN documented on 2/16/23, a BS of 264 mg/dL., with no physician notification evidenced. The agency failed to ensure the POC included orders and safety parameters concerning all services furnished by SN. The above findings were reviewed and acknowledged by the Agency's Administrator and the Director of Operations on 3/10/23 at 1:45 PM.

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 a significant change in condition concerning the following: development of a pressure ulcer, excessive weight gain with congestive heart failure, and elevated blood sugar readings with no reportable parameters for 1 (MR#1) record, from a total sample of 3 records reviewed, resulting in the potential to negatively affect the health and well-being of this patient. Findings include: The subject of the compliant (MR#1), was admitted to the agency on 1/23/23 with diagnoses which included congestive heart failure (CHF), diabetes-type 2, chronic kidney disease, and acute respiratory failure. The referral for home care noted the patient had been hospitalized (1/11/23 to 1/21/23) from exacerbation (worsening) of heart failure due to fluid overload. The medical history was positive for a BKA (below the knee amputation) on 12/29/2019. The physician physical exam on day of hospital discharge documented no skin breakdown with no wound care treatments needed. However, the patient was taken to the ER on 2/13/23 for evaluation of a BKA pressure ulcer. On 3/10/23, review of the record noted the patient’s Plan of Care (POC) ordered Skilled Nursing (SN) at a frequency of 2W1 (twice a week for one week), followed by 1W7. SN performed its ordered weekly visit on 2/16/23 after the ER visit and documented a newly developed pressure ulcer at the BKA site (length 2cm., width 2cm., and depth 0 cm.) with scant drainage without odor. Wound care interventions were noted by SN on the following dates: 2/16/23, 2/22/23, 3/1/23. No evidence was found in the medical record indicating the physician had been notified regarding the change in the patient's condition since 2/16/23. In addition, the patient's POC stipulated physician notification of a weight gain of 5 or more pounds in 7 days for potential fluid overload/CHF exacerbation. SN failed to notify the physician of an 8-pound weight gain (2/22/23-234 pounds, 3/1/23-242 pounds). Also, the documented blood sugar on 2/16/23 for the patient was 264 mg/dL. with no notification evidenced in the medical record. The above findings were reviewed and acknowledged by the Agency's Administrator and the Director of Operations on 3/10/23 at 1:45 PM. The agency failed to ensure the physician was promptly notified concerning significant findings which put the health and safety of the patient at risk.

On 7/27/21 through 7/30/21, the Michigan Department of Licensing and Regulatory Affairs conducted a recertification survey at AdvisaCare Solutions of Kalamazoo. This was a standard survey. The requirements for participation in Medicare at 42 CFR 484.102 Emergency Preparedness were not reviewed.

The following standard level deficiencies were identified during the Medicare recertification survey conducted by the Michigan Department of Licensing and Regulatory Affairs (LARA) July 27, 2021 to July 30, 2021 at: Advisacare Solutions of Kalamazoo 5401 Portage Rd., Suite 1 Portage, MI 49002 At the time of survey the HHA did not operate any branch sites. For this survey 6 records with home visits and 11 records without home visits were reviewed for a total of 17 records reviewed.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to inform the patient in advance of the disciplines that will furnish care in 3 records reviewed (MR# 14, 15, 16) from a total sample of 17 records reviewed, resulting in the patient not having knowledge of the plan for treatment and potential unmet care needs. Findings include: MR#14: The Start of Care (SOC) was dated 5/21/21. The Plan of Care (POC) identified diagnoses of Intestinal Obstruction and Atherosclerosis Heart Disease. During record review on 7/28/21, it was noted that the referral dated 5/19/21 documented, "Additional Home: Home Health Aide ...HHA service requested: To assist with personal care." The Comprehensive Assessment completed on 5/21/21 documented, "Orders for Discipline and Treatments. SN (Skilled Nursing): 1w1 (1 time a week for 1 week), 3w8, 1w1. PT (Physical Therapy): Declined. OT (Occupational Therapy): Declined." There was no documentation that the patient declined HHA services. The agency failed to provide HHA services as referred. MR#15: The Start of Care (SOC) was dated 6/26/21. The Plan of Care (POC) identified diagnoses of Spinal Stenosis, Pain in Left Hip, Muscle Weakness and Diabetes Type 2. During record review on 7/27/21, it was noted that the referral dated 6/23/21 documented, "Required Home Health Services: Physical Therapy. Additional Home Health Services: Occupational Therapy." The Comprehensive Assessment completed on 6/26/21 documented, "Orders for Discipline and Treatments. PT: 1w1, 2w4." There was no documentation that the patient refused OT services. The agency failed to provide OT services as referred. MR#16: The Start of Care (SOC) was dated 11/27/20. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure (CHF), Urinary Tract Infection and Dysphagia. During record review on 7/27/21, it was noted that the referral dated 11/25/20 documented, "D/C tomorrow: PT, OT, ST, RN, HHA." The Comprehensive Assessment completed on 11/27/20 documented, "Orders for Discipline and Treatments. SN: 1w1, 2w1, 1w1. PT: 1w1, 2w3, 1w1. OT: 2w4. ST: 1w4. Furthermore, under the section "Type of Assistance Patient Receives - other than from home health agency staff" documented the comment, "Patient will be evaluated for home health aide help through comfort keepers and senior resources on Tuesday and Wednesday." There was no documentation that the patient declined HHA services. The agency failed to provide HHA services as referred. The Adm#1 was questioned on 7/30/21 at 1:15 pm and confirmed the findings.

Payment from federally funded programs CFR(s): 484.50(c)(7)(i, ii, iii, iv) Be advised, orally and in writing, of- (i) The extent to which payment for HHA services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (ii) The charges for services that may not be covered by Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (iii) The charges the individual may have to pay before care is initiated; and (iv) Any changes in the information provided in accordance with paragraph (c)(7) of this section when they occur. The HHA must advise the patient and representative (if any), of these changes as soon as possible, in advance of the next home health visit. The HHA must comply with the patient notice requirements at 42 CFR 411.408(d)(2) and 42 CFR 411.408(f). This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to inform the patient/caregiver before care was initiated of the extent to which payment for home health agency services may be expected from Medicare or other insurance sources and the extent to which payment may be required from the patient in 14 of 17 records reviewed (MR#s 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 14, 15, 17), resulting in the potential for undisclosed charges. Findings included: MR#11: The Start of Care (SOC) was dated 6/18/21. The Plan of Care (POC) identified diagnoses of Embolism and Thrombosis of other parts of Aorta and Atherosclerosis Heart Disease. Upon review of the record, it was noted that the Admission Consent was not in the EMR (Electronic Medical Record). MR#12: The Start of Care (SOC) was dated 1/8/21. The Plan of Care (POC) identified diagnoses of Acute Posthemorrhagic Anemia and Gastrointestinal Hemorrhage. Upon review of the record, it was noted that the Admission Consent failed to include the amount the patient would be responsible to pay for services from the agency. The area under "Authorization for payment" is blank in the area to document the possible Co-pay for which the patient may be responsible for and the possible percentage the insurance would pay. The home health agency failed to advise the patient, in writing, of the possible charges they may be responsible for paying before care was initiated. MR#13: The Start of Care (SOC) was dated 7/22/21. The Plan of Care (POC) identified diagnoses of Lymphedema Ulcer to Right Medial Lower Leg and Sepsis. Upon review of the record, it was noted that the Admission Consent failed to include the percentage that services would be covered at. The area under "Authorization for payment" is blank in the area to document the possible percentage the insurance would pay. The home health agency failed to advise the patient, in writing, of the possible charges they may be responsible for paying before care was initiated. MR#14: The Start of Care (SOC) was dated 5/21/21. The Plan of Care (POC) identified diagnoses of Intestinal Obstruction and Atherosclerosis Heart Disease. Upon review of the record, it was noted that the Admission Consent failed to include the amount the patient would be responsible to pay for services from the agency. The area under "Authorization for payment" is blank in the area to document the possible Co-pay for which the patient may be responsible for and the possible percentage the insurance would pay. The home health agency failed to advise the patient, in writing, of the possible charges they may be responsible for paying before care was initiated. MR#15: The Start of Care (SOC) was dated 6/26/21. The Plan of Care (POC) identified diagnoses of Spinal Stenosis, Pain in Left Hip, Muscle Weakness and Diabetes Type 2. Upon review of the record, it was noted that the Admission Consent failed to include the amount the patient would be responsible to pay for services from the agency. The area under "Authorization for payment" is blank in the area to document the possible Co-pay for which the patient may be responsible for. The home health agency failed to advise the patient, in writing, of the possible charges they may be responsible for paying before care was initiated. MR#17: The Start of Care (SOC) was dated 5/31/21. The Plan of Care (POC) identified diagnoses of Open Wound Right Upper Arm, Contusion of Thorax and Urinary Tract Infection. Upon review of the record, it was noted that the Admission Consent failed to include the percentage that services would be covered at. The area under "Authorization for payment" is blank in the area to document the possible percentage the insurance would pay. The home health agency failed to advise the patient, in writing, of the possible charges they may be responsible for paying before care was initiated. The Adm#1 was questioned on 7/30/21 at 1:15 pm and confirmed the findings stating, "Those were not filled out properly." MR#1: The Start of Care (SOC) was dated 4/08/2021. The Plan of Care (POC) identified diagnoses of Acute Respiratory Failure with hypoxia and hypercapnia, pneumonia, chronic obstructive pulmonary disease (COPD), Congestive Heart Failure (CHF), Atrial Fibrillation (A-fib) and Encephalopathy. During a review of the record, it was noted that the patient consent was not downloaded into the electronic record. During an interview with the Administrator (ADM#1) on 7/28/2021 at 3:30 p.m., ADM#1 was asked if the agency kept the patient consents in files maintained in the office. ADM#1 stated, "I will look for the consents." At 4:30 p.m. ADM#1 stated, I cannot find any consents for this chart. MR#2: The Start of Care (SOC) was dated 2/9/2021, the Plan of Care (POC) for the Certification Period 2/9/2021 to 4/9/2021 identified diagnoses of Congestive Heart Failure (CHF), Diabetes Mellitus (DM2) with Stage 4 Chronic Kidney Disease (CKD4), Anemia, Acute Chronic Respiratory Failure with Hypoxia (CRF). During a review of the record, it was noted that the patient consent was not downloaded into the electronic record. During an interview with the Administrator (ADM#1) on 7/28/2021 at 3:30 p.m., ADM#1 was asked if the agency kept the patient consents in files maintained in the office. ADM#1 stated, "I will look for the consents. At 4:30 p.m. ADM#1 stated, I cannot find any consents for this chart." MR#6: The Start of Care (SOC) was dated 7/06/2021. The Plan of Care (POC) for the certification period 7/6/2021 to 9/3/2021 identified diagnosis of Orthopedic aftercare, Chronic Obstructive Sleep Apnea, Asthma, Coronary Artery Disease (CAD), Hypertension (HTN), and Gastro-intestinal reflux. During a review of the record, it was noted that the patient consent was not downloaded into the electronic record. During an interview with the Administrator (ADM#1) on 7/28/2021 at 3:30 p.m., ADM#1 was asked if the agency kept the patient consents in files maintained in the office. ADM#1 stated, "I will look for the consents. At 4:30 p.m. ADM#1 stated, I cannot find any consents for this chart." During an interview with the Administrator on 7/28/2021 at 5:00 p.m., ADM#1 confirmed she could not find any consents for chart #s 1, 2, or 6, I can only assume either the staff are not turning them in, or they are not completing them. I will contact the staff who are still employed with us to see what might have happened to them and I will give you a copy if found before you leave the survey." MR#3: The Start of Care (SOC) was dated 4/11/2020. The Plan of Care (POC) for the Certification Period 6/5/21 to 8/3/21 identified diagnoses of Stage 4 Ulcer of Left Buttock, Open wound of right ankle, quadriplegia, Cognitive Communication Deficit, Dysphagia, and aphasia as a result of a motorcycle accident. The patient has been on service with this agency since the initial admission dated 4/11/2020. During a Survey Home visit with the patient on 7/28/2021 at 9:00 a.m., it was noted the patient did not have a copy of the admission consent in his home packet. Upon return to the Agency, the Administrator (ADM#1) was asked to provide a copy of the patients Admission Consent which was provided on 7/29/2021. Upon review of the consent dated 4/11/20, it was noted that the sections for notifying the patient of the amount that may be billed to Medicare or other responsible payor sources and the amount the patient may have to pay were left blank. During an interview at the time of discovery on 7/29/2021 at 4:10 p.m., Adm#1 confirmed the above information had not been documented on the consent form during admission of the patient. MR#4: The Start of Care (SOC) was dated 7/19/21. The Plan of Care (POC) for the certification period 7/19/21 to 9/16/21 identified diagnoses of Bicondylar Fracture Right Tibia, Tear of Lateral Meniscus or Right Knee, Pain in Right Knee, Dorsalgia (pain in upper back), Diabetes type 2 (DM2), and Hypertensive Heart Disease. During a survey home visit on 7/28/2021 at 2:00 p.m. the patient's home packet and consent were reviewed. Upon review of the consent dated 7/19/21, it was noted that the sections for notifying the patient of the amount that may be billed to Medicare or other responsible payor sources and the amount the patient may have to pay were left blank. During an interview upon return to the agency at 3:30 p.m. Adm#1 stated, "yes, I am aware, the consent form is supposed to be filled out by the staff person admitting the patient, but it is not being fully completed by my staff." MR#5: The Start of Care (SOC) was dated 5/18/2021. The Plan of Care (POC) for the certification period 5/18/2021 to 7/16/2021 identified diagnoses of Fibromyalgia, Muscle Weakness, Polyneuropathy, Chronic Kidney Disease (CKD), Chronic Obstructive Pulmonary Disease (COPD) and Asthma. Upon review of the consent dated 5/18/21, it was noted that the sections for notifying the patient of the amount that may be billed to Medicare or other responsible payor sources and the amount the patient may have to pay were left blank. During an interview on 7/28/21 at 3:30 p.m. Adm#1 stated, "yes, I am aware, the consent form is supposed to filled out by the staff person admitting the patient, but it is not being fully completed by my staff." MR #7: The Plan of Care stated the patient was admitted on 7-10-21 for physical therapy services with a primary diagnosis of central pain syndrome. Upon review of the Admission Consent form, dated 7-10-21, it was noted that the sections for notifying the patient of the amount that may be billed to Medicare or other responsible payor source and the amount the patient may have to pay were left blank. During an interview on 7-30-21 at 2:10 PM ADM-1 stated, "the consent form is supposed to be filled out by the staff person admitting the patient, but I guess they are not doing it." MR #9: The Plan of Care stated the patient was admitted on 6-24-21 for physical therapy therapy services with a primary diagnosis of multisystem inflammatory syndrome. Upon review of the Admission Consent form, dated 6-24-21, it was noted that the section for notifying the patient of the amount that may be billed to Medicare or other responsible payor source was left blank. During an interview on 7-30-21 at 2:10 PM ADM-1 stated, "the consent form is supposed to be filled out by the staff person admitting the patient, but I guess they are not doing it."

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: MR #8: The Plan of Care dated 6-3-21 stated the patient was admitted for physical therapy and occupational therapy services with a primary diagnosis of insomnia (difficulty sleeping). During review of the start of care comprehensive assessment, dated 6-3-21, it was noted under the "Primary Diagnosis and Other Diagnoses"section, the 16 diagnoses listed had the same date of exacerbation or onset documented, 6-3-21. There were no documented prior treatments, outcomes, or history of how these diagnoses led to the need for home care/events leading to home care. During an interview on 7-30-21 at 2:20 PM ADM-1 stated, "The start of care assessment should tell you what's going on with the patient, but it doesn't." MR #9: The Plan of Care dated 6-24-21 stated the patient was admitted for physical therapy services with a primary diagnosis of multisystem inflammtory syndrome (inflammation in multiple systems in the body). During review of the start of care comprehensive assessment, dated 6-24-21, it was noted under the "Primary Diagnosis and Other Diagnoses"section, the 19 diagnoses listed had the same date of exacerbation or onset documented, 6-24-21. There were no documented prior treatments, outcomes, or history of how these diagnoses led to the need for home care/events leading to home care. During an interview on 7-30-21 at 2:20 PM ADM-1 stated, "The start of care assessment should tell you what's going on with the patient, but it doesn't." 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, and history of events leading to current home care needs in 16 of 17 records reviewed (MR#s 1, 2, 3, 4, 5, 6, 7, 8, 10, 11, 12, 13, 14, 15, 16, 17), resulting in incomplete clinical information to aid in determining the needs of the patient and determining progress towards goals. Findings included: MR#1: The Start of Care (SOC) was dated 4/08/2021. The Plan of Care (POC) identified diagnoses of Acute Respiratory Failure with hypoxia and hypercapnia, pneumonia, chronic obstructive pulmonary disease (COPD), Congestive Heart Failure (CHF), Atrial Fibrillation (A-fib) and Encephalopathy. Upon review of the Comprehensive Assessment on 7/30/2021, it was noted that the SOC comprehensive assessment dated 4/08/21, documented under "Primary Diagnosis and Other Diagnoses", all 24 diagnoses had the same date of exacerbation and onset documented, 4/08/21. No 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 2/9/2021, the Plan of Care (POC) for the Certification Period 2/9/2021 to 4/9/2021 identified diagnoses of Congestive Heart Failure (CHF), Diabetes Mellitus (DM2) with Stage 4 Chronic Kidney Disease (CKD4), Anemia, Acute Chronic Respiratory Failure with Hypoxia (CRF). On 7/30/2021, it was noted that the SOC comprehensive assessment dated 6/18/21, documented under "Primary Diagnosis and Other Diagnoses", all 23 diagnoses had the same date of exacerbation and onset documented, 2/09/21. No 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 4/11/2020. The Plan of Care (POC) for the Certification Period 6/5/21 to 8/3/21 identified diagnoses of Stage 4 Ulcer of Left Buttock, Open wound of right ankle, quadriplegia, Cognitive Communication Deficit, Dysphagia, and aphasia as a result of a motorcycle accident. On 7/27/21, it was noted that the SOC comprehensive assessment dated 6/18/21, documented under "Primary Diagnosis and Other Diagnoses", all 23 diagnoses had the same date of exacerbation and onset documented. No prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. MR#4: The Start of Care (SOC) was dated 7/19/21. The Plan of Care (POC) for the certification period 7/19/21 to 9/16/21 identified diagnoses of Bicondylar Fracture Right Tibia, Tear of Lateral Meniscus or Right Knee, Pain in Right Knee, Dorsalgia (pain in upper back), Diabetes type 2 (DM2), and Hypertensive Heart Disease. On 7/27/21, it was noted that the SOC comprehensive assessment dated 6/18/21, documented under "Primary Diagnosis and Other Diagnoses", all 9 diagnoses had the same date of exacerbation and onset documented. No prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. MR#5: The Start of Care (SOC) was dated 5/18/2021. The Plan of Care (POC) for the certification period 5/18/2021 to 7/16/2021 identified diagnoses of Pylonephrosis, Muscle Weakness Polyneuropathy, Fibromyalgia, Muscle Weakness, Polyneuropathy, Myoneural Disorder, Chronic Kidney Disease (CKD), Chronic Obstructive Pulmonary Disease (COPD) and Asthma. On 7/27/21, it was noted that the SOC comprehensive assessment dated 5/18/21, documented under "Primary Diagnosis and Other Diagnoses", all 25 diagnoses had the same date of exacerbation and onset documented. No prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. In addition, on 7/28/2021 a review of the Recertification Comprehensive Assessment dated 7/14/2021 revealed no documentation of primary or other diagnoses, that area of the recertification OASIS was completely blank. MR#6: The Start of Care (SOC) was dated 7/06/2021. The Plan of Care (POC) for the certification period 7/6/2021 to 9/3/2021 identified diagnosis of Orthopedic aftercare, Chronic Obstructive Sleep Apnea, Asthma, Coronary Artery Disease (CAD), Hypertension (HTN), and Gastro-intestinal reflux. On 7/29/21, it was noted that the SOC comprehensive assessment dated 6/18/21, documented under "Primary Diagnosis and Other Diagnoses", all 25 diagnoses had the same date of exacerbation and onset documented. No prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. These findings were reviewed and acknowledged by the Administrator during an interview on 7/30/2021 at 2:00 p.m. MR#10: The Start of Care (SOC) was dated 10/3/20. The Plan of Care (POC) identified diagnoses of Diabetes Type 2, Dementia and Osteoarthritis. During record review on 7/30/21, it was noted that the SOC comprehensive assessment dated 10/3/20, documented under "Primary Diagnosis and Other Diagnoses", all 17 diagnoses had the same date of exacerbation and onset documented, 10/3/20. No prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. MR#11: The Start of Care (SOC) was dated 6/18/21. The Plan of Care (POC) identified diagnoses of Embolism and Thrombosis of other parts of Aorta and Atherosclerosis Heart Disease. During record review on 7/29/21, it was noted that the SOC comprehensive assessment dated 6/18/21, documented under "Primary Diagnosis and Other Diagnoses", all 20 diagnoses had the same date of exacerbation and onset documented, 6/18/21. No prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. MR#12: The Start of Care (SOC) was dated 1/8/21. The Plan of Care (POC) identified diagnoses of Acute Posthemorrhagic Anemia and Gastrointestinal Hemorrhage. During record review on 7/28/21, it was noted that the SOC comprehensive assessment dated 1/8/21, documented under "Primary Diagnosis and Other Diagnoses", all 12 diagnoses had the same date of exacerbation and onset documented, 1/8/21. No prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. MR#13: The Start of Care (SOC) was dated 7/22/21. The Plan of Care (POC) identified diagnoses of Lymphedema Ulcer to Right Medial Lower Leg and Sepsis. During record review on 7/29/21, it was noted that the SOC comprehensive assessment dated 7/22/21, documented under "Primary Diagnosis and Other Diagnoses", all 10 diagnoses had the same date of exacerbation and onset documented, 7/22/21. No prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. MR#14: The Start of Care (SOC) was dated 5/21/21. The Plan of Care (POC) identified diagnoses of Intestinal Obstruction and Atherosclerosis Heart Disease. During record review on 7/28/21, it was noted that the SOC comprehensive assessment dated 5/21/21, documented under "Primary Diagnosis and Other Diagnoses", all 20 diagnoses had the same date of exacerbation and onset documented, 5/21/21. No prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. MR#15: The Start of Care (SOC) was dated 6/26/21. The Plan of Care (POC) identified diagnoses of Spinal Stenosis, Pain in Left Hip, Muscle Weakness and Diabetes Type 2. During record review on 7/27/21, it was noted that the SOC comprehensive assessment dated 6/26/21, documented under "Primary Diagnosis and Other Diagnoses", all 15 diagnoses had the same date of exacerbation and onset documented, 6/26/21. No prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. MR#16: The Start of Care (SOC) was dated 11/27/20. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure (CHF), Urinary Tract Infection and Dysphagia. During record review on 7/27/21, it was noted that the SOC comprehensive assessment dated 11/27/20, documented under "Primary Diagnosis and Other Diagnoses", all 14 diagnoses had the same date of exacerbation and onset documented, 11/27/20. No prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. MR#17: The Start of Care (SOC) was dated 5/31/21. The Plan of Care (POC) identified diagnoses of Open Wound Right Upper Arm, Contusion of Thorax and Urinary Tract Infection. During record review on 7/27/21, it was noted that the SOC comprehensive assessment dated 5/31/21, documented under "Primary Diagnosis and Other Diagnoses", all 20 diagnoses had the same date of exacerbation and onset documented, 5/31/21. No prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. The Adm#1 was questioned on 7/30/21 at 1:00 pm and confirmed the findings.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the agency failed to ensure the medical record contained documentation of a complete drug regime review and the findings of such review in 5 of 17 records reviewed of a total sample of 17 records reviewed (MR # 6, 7, 8, 9, 16). Findings include: MR #7: The plan of care stated the patient was admitted on 7-10-21 for physical therapy services, with diagnoses that included central pain syndrome and cervicalgia (pain from nerves in the neck). The plan of care stated the patient was taking 7 medications. During the 7-29-21 record review it was noted that there was no evidence the patient's medications were reviewed for potential interactions. During an interview on 7-30-21 at 2:37 ADM-1 stated, "The medication interactions report should be located under the miscellaneous section of the electronic medical record." There was no medication interaction report found in that section of the record. MR #8: The plan of care stated the patient was admitted on 6-3-21 for physical therapy services, with diagnoses that included Insomnia (inability to sleep), Low back pain and osteoarthritis. The plan of care stated the patient was taking 14 medications. During the 7-30 -21 record review it was noted that there was no evidence the patient's medications were reviewed for potential interactions. During an interview on 7-30-21 at 2:37 ADM-1 stated, "The medication interactions report should be located under the miscellaneous section of the electronic medical record." There was no medication interaction report found in that section of the record. MR #9: The plan of care stated the patient was admitted on 6-24-21 for nursing and physical therapy services, with diagnoses that included multisystem inflammatory syndrome (inflammation/swelling of multiple body systems), gallbladder cancer and polyneuropathy (nerve pain in multiple areas of the body). The plan of care stated the patient was taking 16 medications. During the 7-30 -21 record review it was noted that there was no evidence the patient's medications were reviewed for potential interactions. During an interview on 7-30-21 at 2:37 ADM-1 stated, "The medication interactions report should be located under the miscellaneous section of the electronic medical record." There was no medication interaction report found in that section of the record. MR#6: The Start of Care (SOC) was dated 7/06/2021. The Plan of Care (POC) for the certification period 7/6/2021 to 9/3/2021 identified diagnosis of Orthopedic aftercare, Chronic Obstructive Sleep Apnea, Asthma, Coronary Artery Disease (CAD), Hypertension (HTN), and Gastro-intestinal reflux. Üpon review of the comprehensive assessment, it was noted the skilled nurse documented under (M2001) Drug Regimen Review: "No issues Found." However, during a review of the listed medications on the Plan of Care via Drugs.Com, it was there were two major interactions noted as follows: 1) cyclobenzaprine combined with hydrocodone; and 2)dexamethasone combine with Hydrocodone. The agency failed to perform a thorough drug regimen review to ensure the safety of the drugs the patient had been prescribed. MR#16: The Start of Care (SOC) was dated 11/27/20. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure (CHF), Urinary Tract Infection and Dysphagia. During record review on 7/27/21, it was noted that the "Drug-Drug Interaction" report was completed and filed into the patient's electronic medical record (EMR) on 12/11/21, 14 days after the SOC. The report noted 5 major Drug-Drug interaction between Nortriptyline and Tramadol, Tramadol and Escitalopram, Gabapentin and Tramadol, Nortriptyline and Potassium Chloride, Nortriptyline and Escitalopram. Additionally, during the entrance interview on 7/27/21 at 10:45 am, ADM#1 stated, "All major medication interactions are faxed or emailed to the primary physician. The agency failed to document that the physician was made aware of the major medication interactions.

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: MR#1: The Start of Care (SOC) was dated 4/08/2021. The Plan of Care (POC) for the certification period 4/8/2021 to 6/6/2021 identified diagnoses of Acute Respiratory Failure with hypoxia and hypercapnia, pneumonia, chronic obstructive pulmonary disease (COPD), Congestive Heart Failure (CHF), Atrial Fibrillation (A-fib) and Encephalopathy. This patient was receiving Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT), Speech Therapy (ST), and Medical Social Work Services. Upon review of the POC on 7/30/2021, it was noted the POC only included interventions and goals for Occupational Therapy. SN and ST performed evaluations only, however, OT performed an evaluation with 8 visits, PT performed an evaluation with 8 visits and 2 missed visits, and the MSW performed an evaluation and discharge with all goals met. The Plan of Care included Interventions and Goals only for Occupational Therapy. There were no interventions or goals documented on the Plan of Care for Physical Therapy or Medical Social Work. These findings were reviewed and acknowledged with the Administrator (ADM#1) at the time of discovery. MR#2: The Start of Care (SOC) was dated 2/9/2021, the Plan of Care (POC) for the Certification Period 2/9/2021 to 4/9/2021 identified diagnoses of Congestive Heart Failure (CHF), Diabetes Mellitus (DM2) with Stage 4 Chronic Kidney Disease (CKD4), Anemia, Acute Chronic Respiratory Failure with Hypoxia (CRF). Upon review of the POC on 7/30/2021, it was noted that the agency failed to include safety precautions for this patient's diagnosis of diabetes. In addition, the goals in the POC were not objectively measurable. Examples included: "Patient will have diagnosis specific interventions/monitoring throughout episode;" "Skilled Nurse to educate and then patient will maintain fluid restriction/sodium restriction compliance during the episode;" Also, there were no goals to address the patient's diagnoses of diabetes or Congestive Heart Failure. The goals in the POC were not individualized to the patient's needs or were they objectively measurable to determine progress towards the goals. MR#3: The Start of Care (SOC) was dated 4/11/2020. The Plan of Care (POC) for the Certification Period 6/5/21 to 8/3/21 identified diagnoses of Stage 4 Ulcer of Left Buttock, Open wound of right ankle, quadriplegia, Cognitive Communication Deficit, Dysphagia, and aphasia, Sick euthyroid syndrome, and chronic pain as a result of a motorcycle accident. Upon review of the POC for the certification period 6/5/21 to 8/3/21 on 7/27/21, it was noted that the Plan of care failed to include measurable goals to determine progress towards goals. Examples included: "Patient will have diagnosis specific interventions/monitoring throughout episode; Wounds will heal without complications." These were the only goals on the Plan of Care for this patient with multiple diagnoses resulting from the motorcycle accident. MR#4: The Start of Care (SOC) was dated 7/19/21. The Plan of Care (POC) for the certification period 7/19/21 to 9/16/21 identified diagnoses of Bicondylar Fracture Right Tibia, Tear of Lateral Meniscus or Right Knee, Pain in Right Knee, Dorsalgia (pain in upper back), Diabetes type 2 (DM2), and Hypertensive Heart Disease. Upon review of the POC on 7/27/21, it was noted that the POC failed to include reportable parameters to address the patient's "acute right knee pain due to surgery and trauma." In addition, the goals on the plan of care were not objectively measurable to determine progress towards goals. Examples for physical therapy included: "Patient will have diagnosis specific interventions/monitoring throughout episode." OT goals included, "Patient will have diagnosis specific interventions/monitoring throughout episode; Patient will increase ability to safely transfer from chair/toilet/bed/seats to standing with use of walker and no assistance to allow patient to increase functional use of bilateral upper extremity's during given ADLs within home and independence with all transfers." MR#5: The Start of Care (SOC) was dated 5/18/2021. The Plan of Care (POC) for the certification period 5/18/2021 to 7/16/2021 identified diagnoses of Pylonephrosis, Escherichia coli and Proteus causing disease, Muscle Weakness, Polyneuropathy, Fibromyalgia, myoneural disorder, Hypertensive Chronic Kidney Disease (CKD), Chronic Obstructive Pulmonary Disease (COPD) and Asthma. Upon review of the POC on 7/28/21 it was noted the interventions were not appropriate for the diagnoses listed on the plan of care. For example: Skilled Nursing included an intervention for Heart Failure as follows: "Instruct patient and/or caregiver to weigh self daily and to report variations of 2 pounds in 24 hours or 5 pounds in 7 days to MD, monitor patient log each visit...Measure Bilateral extremity edema and report changes of 2 cm or greater to MD each visit." There was no diagnosis of heart failure listed on the Plan of Care or the following Recertification Plan of Care. In addition, the goals were not objectively measurable to determine progress towards goals. Examples include: "Patient will have diagnosis specific interventions/monitoring throughout episode; The patient will have no hospitalizations during the certification period." These were the only goals for skilled nursing for this episode. There were no goals to address the patient's diagnoses of Pylonephrosis, Escherichia coli or Proteus infections, the polyneuropathy, or Chronic Obstructive Pulmonary Disease or Asthma. These findings were reviewed and acknowledged by the Administrator (Adm#1) at the time of discovery. MR#6: The Start of Care (SOC) was dated 7/06/2021. The Plan of Care (POC) for the certification period 7/6/2021 to 9/3/2021 identified diagnosis of Orthopedic aftercare, Chronic Obstructive Sleep Apnea, Asthma, Coronary Artery Disease (CAD), Hypertension (HTN), and Gastro-intestinal reflux. The patient was being seen for wound care of 2 separate wounds (one on lower abdomen, and one on the lumbar spine); and for observation of the healing process. Upon review of the record on 7/29/2021, it was noted that the wound care was documented on the comprehensive assessment dated 7/6/2021, as follows, "Cleansed over steri-strips and surrounding tissues with Normal Saline and Sterile Gauze. Applied Telfa dressing of Steri-Strips and applied ABD dressing over Telfa, and secured ABD to surrounding skin with paper tape. however, wound care orders were not included as an intervention on the Plan of Care. In addition, there were no reportable parameters to address the patient's pain. The comprehensive assessment documented the patient's pain at a 5 with the patient's goal as 3 out of 10 on a numerical pain scale. The Plan of Care did not include reportable pain parameters for this patient. Also, the goals on the Plan of Care were not objectively measurable. For example, for Nursing the goals included the following: "Wound will heal without complications by end of episode; and Patient will have diagnosis specific interventions/monitoring throughout episode." These goals are not patient specific nor objectively measurable. These findings were reviewed and acknowledged by the Administrator (Adm#1) during an interview on 7/30/21 at 2:00 p.m. MR#11: The Start of Care (SOC) was dated 6/18/21. The Plan of Care (POC) identified diagnoses of Embolism and Thrombosis of other parts of Aorta and Atherosclerosis Heart Disease. The POC dated 6/18/21 stated, "Allergies: NKA (No Known Allergies)." The hospital history and physical attached to the referral dated 6/13/21 documented the following allergy: Sulfonamide Antibiotics. The agency failed to document and accurately assess the patient's allergy. MR#16: The Start of Care (SOC) was dated 11/27/20. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure (CHF), Urinary Tract Infection and Dysphagia. The POC dated 11/27/20 stated, "Allergies: NKA (No Known Allergies)." The hospital history and physical attached to the referral dated 11/25/20 documented the following allergies: Erythromycin, Penicillin's, Sulfa drugs. The agency failed to document and accurately assess the patient's allergies. MR#17: The Start of Care (SOC) was dated 5/31/21. The Plan of Care (POC) identified diagnoses of Open Wound Right Upper Arm, Contusion of Thorax and Urinary Tract Infection. During review on 7/27/21, it was noted that the Comprehensive Assessment completed on 5/31/21, documented that the patient had a pain level of 9. The POC failed to contain pain parameters to notify the physician. The Adm#1 was questioned on 7/30/21 at 1:15 pm and confirmed the findings. Based on record review and interview, it was determined the agency failed to ensure the plan of care included interventions for each discipline providing services, measurable outcomes, pertinent safety precautions, reportable weight and pain parameters, and allergies in 12 of 17 records reviewed (MR #s 1, 2. 3, 4, 5, 6, 7, 8, 9, 11, 16, 17) of a total sample of 17 records reviewed, resulting in the potential for poor patient outcomes, patient injury or untreated pain. Findings include: ** Agency policy "III.7 Professional/Ancillary Care Plans," (undated) stated, "An individuallized plan of care (also called the care plan) shall be developed and implemented by each professional discipline providing service... Each plan will include:... Date of onset for each problem... Specific, individualized, measurable goals and interventions, including goals related to patient/caregiver education and training... Safety measures including use of specific equipment..." MR #7: The plan of care stated the patient was admitted on 7-10-21 for physical therapy services, with diagnoses that included central pain syndrome and cervicalgia (pain from nerves in the neck). On the start of care assessment, dated 7-10-21, the Physical Therapist documented the patient had right upper and lower extremity pain at a level of 5 out of 10 and takes Fentynal Patches, Tylenol and Ibuprofen for pain. During the review of the plan of care for the period of 7-10-21 to 9-7-21, it was noted that the plan did not include reportable pain parameters. MR #8: The plan of care stated the patient was admitted on 6-3-21 for physical therapy services, with diagnoses that included Insomnia (inability to sleep), Low back pain and osteoarthritis. On the start of care assessment, dated 6-3-21, the Physical Therapist documented the patient had knee and back pain at a level of 6 out of 10 and takes Tylenol for pain. During the review of the plan of care for the period of 6-3-21 to 8-1-21, it was noted that the plan did not include reportable pain parameters. MR #9: The plan of care stated the patient was admitted on 6-24-21 for nursing and physical therapy services, with diagnoses that included multisystem inflammatory syndrome (inflammation/swelling of multiple body systems), gallbladder cancer and polyneuropathy (nerve pain in multiple areas of the body). On the start of care assessment, dated 6-24-21, the Registered Nurse documented the patient had pain in her right side at a level of 9 out of 10 and takes Oxycodone for pain. During the review of the plan of care for the period of 6-24-21 to 8-22-21, it was noted that the plan did not include reportable pain parameters. During an interview on 7-30-21 at 2:15 PM, ADM-1 confirmed and agreed with the above findings.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure services were provided only as ordered by the physician in 3 of 17 (MR #12, 14, 17) records reviewed, resulting in the potential for the provision of inappropriate care and services. Findings include: MR#12: The Start of Care (SOC) was dated 1/8/21. The Plan of Care (POC) identified diagnoses of Acute Posthemorrhagic Anemia and Gastrointestinal Hemorrhage. During record review on 7/28/21, it was noted the POC contained the following reportable heart rate parameters: Pulse greater than 100. The Physical Therapist (PT) documented 3 high heart rate readings with a 103 on 1/12/21, 110 on 1/14/21, and 107 on 1/19/21. There was no documented evidence that the physician was made aware of the high heart rate reading. MR#14: The Start of Care (SOC) was dated 5/21/21. The Plan of Care (POC) identified diagnoses of Intestinal Obstruction and Atherosclerosis Heart Disease. During record review on 7/28/21, it was noted the POC contained the following reportable blood pressure parameters: Diastolic BP less than 60. The Skilled Nurse (SN) documented 5 low diastolic BP readings with a 56 on 5/31/21, 58 on 6/2/21, 56 on 6/14/21, 58 on 6/21/21, and 57 on 6/28/21. There was no documented evidence that the physician was made aware of the low blood pressure reading. MR#17: The Start of Care (SOC) was dated 5/31/21. The Plan of Care (POC) identified diagnoses of Open Wound Right Upper Arm, Contusion of Thorax and Urinary Tract Infection. During record review on 7/27/21, it was noted the POC contained the following reportable heart rate parameters: Pulse less than 60. The SN documented 4 low heart rate readings with a 54 on 5/31/21, 56 on 6/7/21, 53 on 6/9/21, and 53 on 6/11/21. There was no documented evidence that the physician was made aware of the low heart rate reading. The Adm#1 was questioned on 7/30/21 at 1:05 pm and confirmed and agreed with the findings.

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: MR#2: The Start of Care (SOC) was dated 2/9/2021, the Plan of Care (POC) for the Certification Period 2/9/2021 to 4/9/2021 identified diagnoses of Congestive Heart Failure (CHF), Diabetes Mellitus (DM2) with Stage 4 Chronic Kidney Disease (CKD4), Anemia, and Acute Chronic Respiratory Failure with Hypoxia (CRF). During a review of the record on 7/30/2021 it was noted that an order to "monitor and log the patients weight each visit and to have the patient record the weight daily. Report to the physician a weight gain or 2 pounds in a 24-hour period, or a weight gain of 5 pounds in 7 days." Record Review revealed that no weights were recorded in 6 of 10 skilled nurse visits. The skilled nurse failed to document the patient's weight each visit as ordered. These findings were reviewed and acknowledged by the Administrator (ADM#1) during an interview on 7/30/2021 at 2:00 p.m. Based on record review and interview, the agency failed to ensure clinical notes were accurate for 2 of 17 (MR#s 2 and 10) records reviewed, resulting in the potential to negatively affect the health and well-being of these patients. Findings include: MR#10: The Start of Care (SOC) was dated 10/3/20. The Plan of Care (POC) identified diagnoses of Diabetes Type 2, Dementia and Osteoarthritis. During record review on 7/30/21, it was noted the Skilled Nurse (SN) failed to document the patient's blood sugars on 10/30/20 and 11/5/20, 2 of the 8 SN visits completed. The agency failed to document blood sugar for this diabetic patient every visit. The Adm#1 was questioned on 7/30/21 at 1:15 pm and confirmed the findings stating, "The blood sugars should have been documented."

Contact information for the patient CFR(s): 484.110(a)(4) Contact information for the patient, the patient's representative (if any), and the patient's primary caregiver(s); This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to have an accurate address on the Plan of Care to determine the actual address that home care services are provided for 2 of 7 patients (MR#s 4 and 6) with planned home visits. Findings included: MR#4: The Start of Care (SOC) was dated 7/19/21. The Plan of Care (POC) for the certification period 7/19/21 to 9/16/21 identified diagnoses of Bicondylar Fracture Right Tibia, Tear of Lateral Meniscus or Right Knee, Pain in Right Knee, Dorsalgia (pain in upper back), Diabetes type 2 (DM2), and Hypertensive Heart Disease. A joint survey home visit was scheduled with the Physical Therapist (PT#2) to be conducted on 7/28/2021 at 2:00 p.m. at the address published on the Plan of Care. The Administrator provided this surveyor with the current Plan of Care which included the patient's home address. Contact information for PT#2 was also provided. Upon arrival to the patient's home and knocking on the door to conduct the survey home visit, no one responded to the knocking on the door. It was noted that the grass at the home was overgrown, and there were no cars in the driveway. At approximately 2:15 p.m., this surveyor received a phone call from PT#2 who stated, I wanted to advise you that the patient is not living at her home address at this time, the patient is actually living with her daughter during her recovery. The survey home visit was conducted after this surveyor arrived at the daughter's address where the patient was currently receiving services from the home health agency. The agency failed to document the correct address in which the patient was receiving services. MR#6: The Start of Care (SOC) was dated 7/06/2021. The Plan of Care (POC) for the certification period 7/6/2021 to 9/3/2021 identified diagnosis of Orthopedic aftercare, Chronic Obstructive Sleep Apnea, Asthma, Coronary Artery Disease (CAD), Hypertension (HTN), and Gastro-intestinal reflux. A joint survey home visit was scheduled with the Occupational Therapist (OT#2) to be conducted on 7/29/2021 at 12:30 p.m. The Administrator provided this surveyor with the current Plan of Care which included the patient's home address. Contact information for OT#2 was also provided. Upon arrival to the patient's home and knocking on the door to conduct the survey home visit, no one responded to the knocking on the door. This surveyor awaited 15 minutes with no signs of the Occupational Therapist or the patient. This surveyor called the Occupational Therapist (OT#2) who stated, "the patient is not currently at his home. The patient is actually staying at his camper at a campground in Vicksburg. You are about 40 minutes away from where the patient is currently located, and I am actually on my way to visit a different patient. The home visit was not conducted due to time constraints of OT#2 and the fact that the agency provided the wrong address on the Plan of Care, and had not advised this surveyor that the patient was not residing at the actual published address as documented on the Plan of Care. During an interview with the Administrator on 7/29/21 at 4:30 p.m., the administrator (Adm#1) was advised that this surveyor was provided the wrong addresses in 2 of 4 scheduled home visits. One visit was conducted late as PT#2 and the patient were willing to wait for the arrival of the surveyor, the second home visit was not conducted due to time constraints and the wrong service addresses were documented on the Plans of Care and the failure of the agency to communicate these patients were not receiving services at the addresses published on their Plans of Care. Adm#1 was asked why the wrong service addresses were documented on the two Plans of Care if Patient #4 and Patient #6 were not receiving services at those addresses? No response was given. The agency documented service addresses on the Plans of Care that were not correct.

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 sent to the physician within 5 business days of the patient's discharge for 4 of 5 (MR#s 1, 2, 10, 12) records reviewed in which the patient was discharged from the agency, resulting in the physician not having knowledge of the patient's health status at the time of discharge and a summary of the care received which has the potential to negatively affect these patients. Findings included: MR#1: The Start of Care (SOC) was dated 4/08/2021. The Plan of Care (POC) identified diagnoses of Acute Respiratory Failure with hypoxia and hypercapnia, pneumonia, chronic obstructive pulmonary disease (COPD), Congestive Heart Failure (CHF), Atrial Fibrillation (A-fib) and Encephalopathy. Upon review of the Discharge Oasis Assessment on 7/30/2021, it was noted that this patient was discharged on 5/31/21 "per patient request." The Occupational Therapist (OT#1) documented "the physician was notified of the discharge from the agency before the discharge date; and physician was notified of discharge summary availability." The Administrator (Adm#1) was questioned regarding documentation of the date the discharge summary was sent to the physician, and the response was, "we do not keep information of the dates discharge summaries are sent." When asked if they had record of any discharge summary sent by FAX, the response was, no we don't keep FAX receipts." The agency failed to verify that the discharge summary was sent to the physician within 5 business days of the patient's discharge. There was no evidence found in the record that the discharge summary had been sent to the physician as required per federal regulation. MR#2: The Start of Care (SOC) was dated 2/9/2021, the Plan of Care (POC) for the Certification Period 2/9/2021 to 4/9/2021 identified diagnoses of Congestive Heart Failure (CHF), Diabetes Mellitus (DM2) with Stage 4 Chronic Kidney Disease (CKD4), Anemia, Acute Chronic Respiratory Failure with Hypoxia (CRF). Physical Therapy discharged this patient on 3/23/21 and Skilled Nursing Discharged this patient on 4/2/2021. Upon review of the Discharge OASIS Assessment on 7/30/2021, it was noted the area for "Care Summary," was blank except for the following documented statement by the Registered Nurse (RN#1): "See Goals and Interventions Completed. Physician notified of discharge prior to discharge date, per agency summary availability, policy, and timeline." {sic} The Administrator (Adm#1) was questioned regarding documentation of the date the discharge summary was sent to the physician, the response was, "we don't keep records of that information." When asked if they had record of any discharge summary sent by FAX, the response was, "no we don't keep FAX receipts." The agency failed to verify that the discharge summary was sent to the physician within 5 business days of the patient's discharge. There was no evidence found in the record that the discharge summary had been sent to the physician as required per federal regulation. MR#10: The Start of Care (SOC) was dated 10/3/20. The Plan of Care (POC) identified diagnoses of Diabetes Type 2, Dementia and Osteoarthritis. The Occupational Therapist (OT) completed a discharge OASIS (outcome and assessment information set) on 11/18/20. The Adm#1 was questioned regarding documentation of the date the discharge summary was sent to the physician, and stated, "We do not have a list of when the discharge was sent." The agency failed to verify that the discharge summary was sent to the physician within 5 business days of the patient's discharge. MR#12: The Start of Care (SOC) was dated 1/8/21. The Plan of Care (POC) identified diagnoses of Acute Posthemorrhagic Anemia and Gastrointestinal Hemorrhage. The OT completed a discharge OASIS (outcome and assessment information set) on 1/29/21. The Adm#1 was questioned regarding documentation of the date the discharge summary was sent to the physician, and stated, "We do not have a list of when the discharge was sent." The agency failed to verify that the discharge summary was sent to the physician within 5 business days of the patient's discharge. Additionally, the Skilled Nursing discharge dated 1/21/21, stated, "Care Summary (care given, progress, regress including therapies): Please see progress notes." The discharge summary failed to detail the course of care provided, responses to treatment, any potential continuing needs, and failed to document the patient's health status at the time of discharge in measurable terms.