Every finding on record at Healthstar Home Care, Inc

An unannounced Medicare Emergency Preparedness survey was conducted by the Michigan Department of Licensing and Regulatory Affairs (MDLARA) from 6/8/26 through 6/10/26 at: Suncare Home Health 8061 21 Mile Rd, Suite 1 Shelby, MI 48317 At the time of the survey, the agency did not operate any branches. Records reviewed: 3 home visits with record review, 1 active record without a home visit, 1 transfer and 2 discharged records for a total of 7 records. At the conclusion of the survey, the agency was found to be in substantial compliance with the Conditions of Participation for Emergency Preparedness at 42 CFR Part 484.102.

EP Training and Testing CFR(s): 484.102(d) §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, "Organizations" under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an Emergency Preparedness training and testing program that is reviewed and updated at least every two years. This deficient practice could affect the health and safety of all agency patients in the event of a natural, man-made, or facility-based emergency. Findings include: During review of the agency's emergency preparedness program on 6/10/26, it was discovered that there was no evidence the agency had documented the content of their exercises for 2024 and 2025, to evaluate the effectiveness of the training, any gaps in the procedures, areas for improvement, after action reports, and the overall emergency preparedness program. The agency documented that employees attended a drill, but there were no details of the drill. During an interview on 6/10/26 at 10:00 a.m., the administrator (Staff-A) acknowledged the above findings.

An unannounced Medicare recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs from 6/8/26 through 6/10/26 at: Suncare Home Health 8061 21 Mile Rd, Suite 1 Shelby, MI 48317 At the time of the survey, the agency did not operate any branches. Records reviewed: 3 home visits with record review, 1 active record without a home visit, 1 transfer and 2 discharged records with a total of 7 records. At the conclusion of the survey, the agency was found to be in substantial compliance with the Conditions of Participation for Home Health Agency Services at 42 CFR Part 484.

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 evidence that initial infection control education was provided for 1 (Staff-E) of 11 staff records reviewed. Findings include: The personnel records for 10 agency employed staff and 1 contracted staff (employed under arrangement) were reviewed on 6/10/26 at 9:25 AM. The review revealed that that agency provided initial and ongoing annual infection control education for the 10-agency staff. The agency did not provide documented evidence that the contracted staff (Staff-E) received initial infection control education at the time of hire (3/15/26). During an interview with the Administrator (Staff-A) and the Alternate Administrator (Staff-C) on 6/10/26 at 10:58 AM, the findings above were reviewed. Staff-C explained that this education is provided electronically and should be documented in the personnel file for all contracted staff. Staff-A and Staff-C acknowledged findings during the interview.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Home Health Aide provided care and services as ordered in the plan of care for 1 (P-6) of 1 patient records reviewed in which Home Health Aide services were provided, resulting in the potential of unmet patient needs. Findings include: Patient #6 (P-6): During the record review on 6/8/26 at 12:48 PM, it noted that Home Health Aide (HHa) services were ordered at a frequency of one day a week for 6 weeks. The review of the HHa plan of care dated 4/6/26, found that the HHa was ordered to report if the patient experienced, “No Bowel Movements in 3 Days.” The review of the HHa visit notes for services provided 4/9/26 through 5/4/26, noted that the field, “Last Bowel Movement” was left blank for 6 out of 6 visits. The HHa did not provide care as ordered by documenting the last bowel movement to determine the need to report if the patient had no bowel movement in 3 days. The Administrator (Staff-A), the Director of Nursing (Staff-B), and the Alternate Administrator (Staff-C) reviewed and acknowledged the findings during an interview on 6/10/26 at 10:58 AM.

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 clinical notes were maintained for 4 (P-3, P-4, P-5 and P-6) of 7 records reviewed, resulting in the potential to negatively affect the health and well-being of these patients. Findings include: Patient #6 (P-6) was admitted to the agency 4/6/26 after being discharged from a skilled nursing facility for continuation of care, for the diagnosis of a hemorrhagic stroke (bleeding in the brain caused by a blood vessel leak) with left side body weakness and neglect. During the record review on 6/9/26 at 12:48 PM, the SN discharge summary visit note dated 4/22/26, noted that the physical therapist was informed that “…patient fell on 4/22/26. Patient sore, no physical injury noted…” and under, “Coordination Plan Regarding (Continued)” it noted a message will be communicated to the provider through the in agency electronic medical record. Further review revealed that SN documented a message in the “Patient Communication” dated 4/22/26 addressed to the physician that stated, “During nursing visit with patient on April 22, 2026, patient and husband reported that patient fell that morning. It was reported that she was standing at the bedside and fell onto her right side. No physical injury noted other than patient being sore on her right side.” Review of the “FAX Transmission Status” attached to the “Patient Communication”, documented the fax was sent 5/1/26 (9 days) after the reported fall, with the message,“Communication note 4/22/26 for your records. Thank you.” The agency failed to accurately document timely physician communication of the patient’s fall. During an interview with the Administrator (Staff-A), the Director of Nursing (Staff-B), and the Alternate Administrator (Staff-C) on 6/10/26 at 10:58 AM, the findings were reviewed. Staff-B explained that the staff call the physician and document the “Patient Communication” that is then faxed to the physician. Staff-A, Staff-B and Staff-C acknowledged the findings and confirmed that SN did not document that the physician was called to communicate the fall. Patient #3’s (P-3) Start of Care (SOC) was dated 1/15/26. The Plan of Care (POC) identified diagnoses of Laceration of Head, Concussion, Fall and Muscle Weakness. During record review on 6/8/26, it was noted the Skilled Nurse (SN) stated, “Vital Signs: BP (Blood Pressure): 166/74. Comments: BP taken later by therapist at next visit: 119/73… Coordination Plan: Physician Contacted Re: Pt (Patient) status, POC…” The vital sign of 166 was highlighted in red, representing an elevated value over the POC parameter stating, “Notify physician of: … Systolic BP greater than (>) 160…” The agency failed to accurately document the physician contact and follow-up. Furthermore, the Physical Therapy Assistant (PTA) documented the following on 4/14/26, 4/21/26 and 4/28/26, “Care Coordination: Conference with: PT (Physical Therapist), SN. Regarding: pt status and POC.” On 4/28/26, the PTA also documented, “Assessment: Summary of Patient Overall Performance on this Visit: … she reported that she had a fall the night before…” An incident report was completed, and the physician was notified on 4/28/26. The PTA failed to accurately document the “Care Coordination” status regarding the fall. Patient #4’s (P-4) Start of Care (SOC) was dated 12/3/25. The Plan of Care (POC) identified diagnoses of Vascular Dementia, Osteoarthritis and Chronic Pain. During record review on 6/9/26, it was noted that the POC ordered Physical Therapy (PT) to “Evaluation and treat”. On 12/5/25, the PT documented a missed visit stating, “Reason: No answer to phone call. Comments: Attempted multiple times to contact pt (patient) - no call back.” On 12/12/26, the PT documented a missed visit stating, “Reason: No answer to phone call. Comments: Attempted multiple times to contact pt and emergency contact – no response.” On 12/12/26 the PT completed an order stating, “Orders: pt/CG (Care Giver) has refused PT services at this time. No PT visit made. Pt with continue with SN and OT (Occupational Therapy).” There is no documented evidence in the EMR (Electronic Medical Record) that a return call was received refusing the PT services. Patient #5’s (P-5) Start of Care (SOC) was dated 5/29/26. The Plan of Care (POC) identified diagnoses of Hemiplegia, Hypotension and Diabetes Type 2. During record review on 6/9/26, it was noted that the PT completed an evaluation on 5/29/26 and stated, “Clinical Statement of Assessment Findings and Recommendations: … Pts BP is low and PCP (Primary Care Physician) notified… Care Coordination: Physician Notified Re: Plan of Care, Goals, Frequency, Duration and Direction.” There is no documented evidence of the physician being notified of the low BP and the response. Furthermore, the POC stated, “Other: Has wound on sacral area… Assessment of patient … Has sacral wound that is at risk for complication/infection…” During a joint home visit survey with Staff-D (Registered Nurse), she was questioned on 6/9/26 at 1:15pm regarding the sacral wound and stated, “P-5 does not have a sacral wound. She had a wound during her last admission.” The agency failed to accurately document within the POC. A review of the agency policy occurred on 6/10/26 titled "Clinical Record Contents and Maintenance" (Undated). The policy states, "The Agency will maintain a clinical record for all patients, initiated during the initial visit from data collected during the assessment process. The record will contain pertinent past and current medical, nursing, social and other information as appropriate to the care and treatment of the patient. The patient’s clinical record will contain data including but not limited to: - Clinical progress notes / visit notes, detailing services rendered and patient response to services.” The Administrator (Staff-A), Clinical Manager (Staff-B) and Alternate Administrator (Staff-C) reviewed and acknowledged the findings listed above in an interview on 6/10/26 at 11:20 am.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to submit the discharge summary to the physician within 5 days of the patients discharge from the agency for 1 (P-1) of 2 discharged records reviewed, resulting in the potential for unidentified continuing health care concerns and unmet care needs. Findings include: Patient#1 (P-1): The start of care was dated 3/13/26, with diagnoses of hypertension, congestive heart failure, and chronic kidney disease. During record review on 6/8/26, it was discovered that the discharge summary dated 4/24/26 had a fax transmittal date of 5/7/26, 13 days after the patient's discharge. During an interview on 6/10/26 at 10:00 a.m., the Administrator (Staff-A) agreed that the discharge summary should have been sent within 5 days of the patient's discharge.

A Medicare recertification survey for Emergency Preparedness was conducted by the Michigan Department of Licensing and Regulatory Affairs from 1/24/23 through 1/27/23 at: Suncare Home Health 8061 21 Mile Rd., Suite 1 Shelby Twp., MI 48317 At the time of the survey, the Agency did not operate any branch offices.At the survey's conclusion, the Agency was found to be in compliance with the requirements for participation in Medicare/Medicaid at 42 CFR §484.102, Emergency Preparedness.

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on document review and interview, the Agency failed to review and update an emergency preparedness plan at least annually, which included strategies to address the Covid-19 global pandemic, resulting in no directions for Agency personnel in the event of an actual emergency or disaster. This deficient practice could negatively affect the health and safety of all patients serviced by this agency in the event of an emergency or disaster. Findings include: On 1/27/23 at 9:50 AM., review of the Agency's Emergency Preparedness (EP) binder revealed no evidence of active participation since 4/2/2020. At 10:25 AM., a request was made to the Administrator (Adm.#1) to review the Governing Board's (GB) review and approval of the Agency's EP program. No evidence was found of the required annual review with subsequent updates since 2020. In addition, the agency-based and community-based risk assessment form was found to be blank. These findings were reviewed and acknowledged by Adm.#1 on 1/27/23 at 10:40 AM.

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to develop and maintain an emergency preparedness plan centered on both agency-based and community-based risk assessments, resulting in a lack of direction and duties for agency personnel in the event of an actual disaster. This deficient practice has the potential to negatively affect the health and safety of the agency's current 18 patients. Findings include: On 1/27/23, the Agency's Emergency Preparedness (EP) information was requested. The Agency’s EP plan since 2020 focused solely on the education, training and testing concerning COVID-19 management and infection control. However, review of the Agency’s facility and community-based risk assessment was found to be blank. Documentation which addressed and detailed the extent of the potential risk of various types of disasters or emergencies including COVID-19, was not found within the EP program. During an interview on 1/27/23 at 10:45 a.m., the Administrator (Adm#1) reviewed the findings and acknowledged that a risk assessment had not been utilized to create the Agency's emergency disaster plan.

The following Condition and Standard level deficiencies were identified during a Medicare authorized Recertification survey concurrent with the vaccine mandate review, conducted by the Michigan Department of Licensing and Regulatory Affairs on 1/24/23 through 1/27/23 at: Suncare Home Health 8061 21 Mile Rd., Suite 1 Shelby Twp., MI 48317 Services Provided: Skilled Nursing, Physical Therapy, Occupational Therapy, Speech Therapy, Medical Social Work, Home Health Aide. Records Reviewed; 3 records with home visits, 2 records without home visits, 3 discharged records, for a total of 8 records. The following Conditions were identified: 42 CFR §484.60: Care Planning, Coordination, Quality of Care. 42 CFR §484.65: Quality Assessment Performance Improvement. 42 CFR §484.75: Skilled Professional Services. As a result of the Condition level noncompliance, the Agency is prohibited for 2 years from offering a Home Health Aide training and competency evaluation or a competency evaluation program as specified in 42 CFR §484.80(f)(3).

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the Agency failed to ensure that 2 (MR's #1, 2) of 3 patients observed during home visits, were included in the overall planning of care including informing the patient/caregiver in advance of the days in which services would be provided, resulting lack of inclusion in planning, the potential for missed visits and unmet care needs. Findings include: MR #1: The patient's start of care (SOC) was 1/21/23 with diagnoses that included Arterial Embolism and Chronic Congestive Heart Failure. During the clinical record review on 1/25/23 at 10:15 a.m., it was noted that Skilled Nursing (SN), Physical Therapy (PT) and Occupational Therapy (OT) services were ordered to be provided. On 1/24/23 at 1:00 p.m., during a scheduled home visit with the Physical Therapist/Administrator, it was noted that the patient's admission packet was void of a calendar of proposed visits to be made. The Agency failed to ensure a calendar of proposed visits had been provided at the SOC to assist the patient with participating in planning his care and daily routine. These findings were reviewed with and acknowledged by the Administrator and Alternate Administrator during an interview on 1/26/23 at 11:00 a.m. MR #2: The patient's SOC was 1/14/23 with diagnoses that included Left total Hip Replacement and Hypertensive Disorder. During the record review on 1/25/23 at 11:00 a.m., it was noted that SN, OT, and PT services were ordered to be provided. On 1/24/23 at 2:46 p.m., a scheduled home visit was conducted with the Occupational Therapist. During the review of the patient's admission packet, it was noted that there was no calendar of proposed visits to be made by the assigned staff. These findings were reviewed with and acknowledged by Adm #1 and Adm #2 during an interview on 1/26/23 at 11:25 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 document review and interview, the Agency failed to ensure the comprehensive assessment included an accurate reflection of the patient’s current health, psychosocial, and functional status in 2 of 8 records reviewed (MR#’s 5 and 7) resulting in incomplete clinical information to aid in determining the needs of these patient. Findings include: Agency Policy: “Comprehensive Assessment and OASIS Data Collection Start of Care: III.8 (undated) stated, “The comprehensive assessment will include, at a minimum: Demographic information and medical history (including dates) …Current health, psychosocial, functional, and cognitive status; Systems review, including sensory, integumentary, respiratory… All pertinent diagnoses…” MR# 5: This 69-year-old patient was admitted to agency on 11/10/22 for diagnoses which included cellulitis of right and left lower limbs, pressure ulcer of sacral region-stage 2, congestive heart failure (CHF) and chronic kidney disease. Record review on 1/25/23 noted the initial comprehensive assessment performed by skilled nursing (SN) dated 11/10/22, had listed 25 of 25 diagnoses as the O/E (Onset/Exacerbation) being 11/10/22 under sections M1021/1023. This was found to be inaccurate when compared to the patient’s medical history found within the physician’s referral for home care. Further, under “Cardiac Status”, the patient was “recently hospitalized” for a heart attack (date unknown). No documentation was found if and how this impacted the patient’s heart failure and subsequent monitoring needs. In addition, the patient’s pressure ulcer, which was documented as open had no depth recorded, and 2 of 4 documented wound interventions had effective dates of 10/12/22 (prior to admission) and 11/18/22 (active wounds on both lower legs). No onset, prior treatments, outcomes, or history of how these diagnoses led to the need for home care was documented within the Comprehensive Assessment completed on 11/10/22. MR# 7: The start of care (SOC) date for this patient was 3/5/22 for diagnoses which included hypertensive heart disease with CHF, chronic kidney disease, and diabetes-type 2. Record review on 1/26/23, noted the initial comprehensive assessment was performed by physical therapy (PT), the only discipline assigned to the case. On 3/5/22, PT had documented 24 of 24 listed diagnoses as the O/E as occurring on 3/5/22 under sections M1021/1023. This was found to be inaccurate when compared to the patient’s medical history found within the physician’s referral for home care. Further, under “Cardiac Status”, no documentation was found which addressed the patient's heart failure. In addition, under "Endocrine", no diabetic history or the patient's ability to manage her diabetes was found. In addition, the referral noted invasive ductal carcinoma of left breast, status post bilateral mastectomy, and documented "Left arm is restricted: No BP (blood pressure)/IV/Labs." The comprehensive assessment by PT failed to note this precaution when performing subsequent vital signs during future home visits. The above findings were reviewed and acknowledged by the Administrator (Adm.#1) during an interview on 1/27/23 at 11:10 AM.

Patient's needs CFR(s): 484.55(c)(4) The patient's medical, nursing, rehabilitative, social, and discharge planning needs; This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the patient's activities of daily living needs were adequately met in the patient's home for 1 (MR #4) patient who required assistance with grooming, from a total of 8 sampled records reviewed, resulting in the potential for low self-esteem and poor hygiene. Findings include: Policy: III.4 Admission Policy stated, "Admission criteria are standards by which a patient is assessed for admission..., and a reasonable expectation that the patient's needs can be adequately met in the patient's place of residence." MR #4: The patient's start of care was 8/26/22 with diagnoses that included Hypertensive Heart Disease with Heart Failure, Urinary Retention and Diabetes Mellitus. The Plan of Care (POC) ordered Skilled Nursing (SN) and Physical Therapy (PT) services to be provided. The patient was discharged from PT services on 10/12/22. On 1/25/23 and 1/26/23 during the clinical record review, it was noted that section M1800 of the Initial Comprehensive Assessment dated 8/26/22 documented that the patient required assistance with grooming. The assessment further revealed the patient had "poor hygiene" and only received "Occasional short term assistance" with activities of daily living. Upon further review, there was no documented evidence that a Home Health Aide had been offered or provided to assist with grooming needs. These findings were reviewed with and acknowledged by the Administrator and Alternate Administrator during an interview on 1/27/23 at 9:35 a.m.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the Comprehensive Assessment included a thorough review of all the patient's medications to identify any adverse drug interactions and failed to ensure the Physician was notified of any untoward findings for 2 (MR's #1, 2) of 2 records, from a total of 8 sampled records reviewed, resulting in the potential for the ingestion of harmful medications and poor patient outcomes. Findings include: Policy: "Medication Management" III.17 undated stated, "The medications will be reviewed for potential adverse effects, drug reactions, ineffective drug therapy, significant drug interactions, duplicate drug therapy, and for patient non-compliance with drug therapy." On 1/24/23 at 10:45 a.m., during a interview, the Alternate Administrator reported, "There is a software that looks at interactions and that report is faxed to the Physician for all interactions." MR #1: The patient's start of care (SOC) was 1/21/23 with diagnoses that included Arterial Embolism and Chronic Congestive Heart Failure. The referral for home care dated 1/19/23 ordered Skilled Nursing (SN), Physical Therapy (PT) and Occupational therapy (OT) services to be provided. Sections M2001/M2003 (Drug Regimen Review for drug interactions, and Medication Follow-up for Physician notification) were both left blank. Further, there was no Medication profile in the clinical record that listed the patient's medications. The patient's 17 prescribed medications were entered in "Drugs.com" (online drug interaction checker) and revealed 4 major drug to drug interactions, 22 moderate drug to drug interactions, 6 drug to food interactions and 3 duplicate drugs. There was no documented evidence that a comprehensive drug review had been conducted in order to ascertain any untoward drug interactions. These findings were discussed with and acknowledged by the Administrator (Adm #1) and Alternate Administrator (Adm #2) during an interview on 1/26/23 at 11:10 a.m. Adm #1 confirmed that no drug review had been conducted at the start of care. MR #2: The patient's SOC was 1/14/23 with diagnoses that included Left total Hip Replacement and Hypertensive Disorder. The referral for home care dated 1/12/23 ordered SN, PT, and OT services to be provided. Sections M2001/M2003 (Drug Regimen Review for drug interactions, and Medication Follow-up for Physician notification) documented "No issues found during review." Further, there was no Medication profile in the clinical record that listed the patient's medications, and no documented evidence that the Drug review had been conducted. The patient's 9 prescribed medications were entered in Drugs.com and revealed 4 moderate drug to drug interactions, 4 drug to food interactions and 3 duplicate drugs. There was no documented evidence that a comprehensive drug review had been conducted in order to ascertain any untoward drug interactions. These findings were reviewed with and acknowledged by Adm #1 and Adm #2 during an interview on 1/26/23 at 11:25 a.m. Adm #1 again acknowledged that no drug review had been conducted at the start of care.

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, the Agency failed to ensure Occupational Therapy services were provided as ordered by the Physician for 2 (MR's #1, 2) patients who required Occupational Therapy services, and failed to ensure Skilled Nursing provided care at the ordered frequency in the plan of care in 1 (MR #5) of 6 records which SN services were provided, from a total of 8 sampled records reviewed, resulting the potential for physiological decline, and functioning and unmet care needs (G572); failed to ensure the plan of care addressed the individualized needs of the patient and included all pertinent interventions with reportable parameters and objectively measurable goals for 5 (MR#'s 5, 6, 8, 2, 4) records, from a total of 8 sampled records reviewed, resulting in patients not receiving care specific to their individualized needs and the potential for unmet patient care needs (G574); failed to provide Occupational Therapy services as ordered by the physician for 2 (MR#’s 6, 8) of 7 records reviewed in which therapy services were ordered from a total sample of 8 records reviewed, resulting in the potential for unrecognized therapeutic needs and sub-optimal outcomes for this patient (G578); failed to ensure all treatments and services were administered only as ordered by the physician, and failed to ensure the plan of care was initiated prior to the provision of care and services for 1 (MR# 2) record, from a total of 8 sampled records reviewed, resulting in the potential for lack of ordered care, the rendering of unsafe, inappropriate, unauthorized care and poor patient outcomes (G580); failed to ensure the Physician was promptly notified of a change in clinical status for 2 (MR#'s 4, 6) patients, and failed to ensure the Physician was promptly notified of adverse drug interactions in 1 (MR# 8) record, from a total of 8 sampled records reviewed, resulting in the Physician not having essential information to address the needs of the patient and the potential for poor patient outcomes (G590). 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 Occupational Therapy services were provided as ordered by the Physician for 2 (MR's #1, 2) patients who required Occupational Therapy services, and failed to ensure Skilled Nursing provided care at the ordered frequency in the plan of care in 1 (MR #5) of 6 records which SN services were provided, from a total of 8 sampled records reviewed, resulting the potential for physiological decline, and functioning and unmet care needs. Findings include: MR #1: The patient's start of care (SOC) was 1/21/23 with diagnoses that included Arterial Embolism and Right Lower Extremity swelling. The referral for home care ordered Skilled Nursing (SN), Physical Therapy (PT) and Occupational Therapy (OT) services to be provided. At the time of this review on 1/25/23 at 10:15 a.m., no OT services had been provided. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Alternate Administrator (Adm #2) during an interview on 1/26/23 at 11:10 a.m. MR #2: The patient's SOC was 1/14/23 with diagnoses that included Left total Hip Replacement and Hypertensive disorder. The referral for home care dated 1/12/23 ordered SN, OT and PT services to be provided. During the record review on 1/25/23 at 11:00 a.m., it was noted that the OT conducted the initial evaluation on 1/24/23 (scheduled home visit with this writer). this was 10 days after the SOC. There were no prior OT visits made. On 1/25/23 during this record review, OT #1/Adm #2 was queried. When asked how soon the Therapy disciplines were expected to conduct their initial evaluation, Adm #2 reported, "We follow the guidelines. They (therapy disciplines) are supposed to see the patient within 24 to 48 hours of the SOC. Sometimes the patient's refuse." When asked if this patient (MR #2) refused or requested that services be delayed, Adm #2 responded, "No." The Agency failed to ensure services were provided as ordered. MR# 5: This 69-year-old patient was admitted to agency on 11/10/22 for diagnoses which included cellulitis of right and left lower limbs, pressure ulcer of sacral region-stage 2, congestive heart failure (CHF) and chronic kidney disease. Record review on 1/25/23 noted the Plan of Care (POC) ordered SN at a frequency of 2wk3 (twice a week times 3 weeks), followed by 1wk2. An order was noted effective 11/29/22, which changed the SN frequency to 2wk3, 1wk1. No follow up orders were found in the medical record which changed the SN visit frequency. Further record review found SN provided visits on 12/27/22, 12/30/22, 1/1/23, and 1/6/23. No orders were found in the medical record which authorized these last 4 visits. These findings were reviewed with and acknowledged by the Administrator and Alternate Administrator during an interview on 1/27/23 at 11:25 AM.

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 addressed the individualized needs of the patient and included all pertinent interventions with reportable parameters and objectively measurable goals for 5 (MR#'s 5, 6, 8, 2, 4) records, from a total of 8 sampled records reviewed, resulting in patients not receiving care specific to their individualized needs and the potential for unmet patient care needs. Findings include: MR# 5: This 69-year-old patient was admitted to agency on 11/10/22 for diagnoses which included cellulitis of right and left lower limbs, pressure ulcer of sacral region-stage 2, congestive heart failure (CHF) and chronic kidney disease. On 1/25/23, review of the patient's Plan of Care (POC) found no reportable parameters (i.e., patient weight or limb circumference measurements) to monitor for exacerbation (worsening) of CHF symptoms and notify the physician. Under skilled nursing (SN) interventions, no examples of specific, detailed instructions/interventions concerning CHF patient education were found within the POC. Further, SN goals which addressed and detailed CHF management that would be measurable were not found. Of the 15 listed goals from SN and physical therapy (PT), none were found to be measurable. Examples include: The patient will verbalize and demonstrate edema-relieving measures; The patient will verbalize understanding of symptoms of cardiac complications and when to call 911; Patient will verbalize understanding when to report vital signs out of parameters to physician. It was unclear how these goals would be objectively measured by the SN to determine progress toward the goals. MR #6: The start of care (SOC) date was 8/26/22 with diagnoses which included hypertensive heart disease with heart failure, abrasions to right and left lower legs, and rheumatoid arthritis. On 1/26/23, review of the patient's POC found 14 listed SN goals, none were found to be measurable. Examples include: The Pt/cg (patient/caregiver) will verbalize understanding of management of anxiety; Patient will verbalize understanding of measures to take to reduce risk of falls; Pt/cg will demonstrate self-management of HTN (hypertension), A fib (atrial fibrillation), and CHF. MR #8: The patient's start of care (SOC) was 10/6/22) with diagnoses that included chronic atrial fibrillation, hypertensive heart disease with heart failure, chronic kidney disease, and diabetes-type 2. On 1/26/23, review of the patient's POC found no reportable parameters to monitor for exacerbation of CHF symptoms and no diabetic parameters in which to notify the physician. Further review of the POC found the 14 listed SN goals were not measurable. Examples include: SN will educate patient on comorbidities of HTN, A fib, and CHF; Patient will verbalize understanding of measures to take to reduce risk of falls; The patient will verbalize understanding of symptoms of cardiac complications and when to call 911. In addition, the SN visit frequency included 2 PRN (as needed) visits with no patient-specific intervention to assess and potentially treat. The above findings were reviewed with and acknowledged by the Administrator and Alternate Administrator during an interview on 1/27/23 at 11:50 AM. MR #2: The patient's start of care (SOC) was 1/14/23 with diagnoses that included left Total Hip Replacement, Hypertensive Disorder and Cerebral Palsy. On 1/24/23, during the Entrance conference, a request was made to establish home visits to observe care. This writer requested to review the Plan of Care (POC) for MR #2 prior to the visit. The Alternate Administrator (Adm #2) responded, "I can't lie to you. We don't have a POC for this patient. It wasn't done yet." The Agency failed to ensure a Plan of Care was developed that met the requirements of this section and served as a guide for the provision of care and services. These findings were reviewed with and acknowledged with Adm #2 at the time of discovery. MR #4: The patient's SOC was 8/26/22 with diagnoses that included Hypertensive Heart Disease with Heart Failure, Urinary Retention and Diabetes Mellitus and presented with "Severe Edema lower extremity." The POC ordered Skilled Nursing and Physical Therapy services to be provided. The patient was discharged from therapy services on 10/12/22. On 1/25/23 and 1/26/23 during a review of the clinical record, it was noted that the POC listed several diagnoses with the same onset date of 8/26/22. It was further noted that the POC was void of interventions, reportable parameters and measurable goals that addressed the patient's admitting diagnoses (Heart Failure, Edema...). There were no interventions to weigh the patient or assess/measure edema. Additionally, there were no clear reportable parameters or associated goals that addressed the above admitting diagnoses. These findings were reviewed with and acknowledged by Adm #2 and the Administrator (Adm #1) during an interview on 1/27/23 at 9:35 a.m.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to provide Occupational Therapy services as ordered by the physician for 2 (MR#’s 6, 8) of 7 records reviewed in which therapy services were ordered from a total sample of 8 records reviewed, resulting in the potential for unrecognized therapeutic needs and sub-optimal outcomes for this patient. Findings included: MR #6: The SOC date was 8/26/22 with diagnoses which included hypertensive heart disease with heart failure, abrasions to right and left lower legs, and rheumatoid arthritis. The Plan of Care (POC) ordered Occupational Therapy (OT) services the week effective 8/29/22 for evaluation and treatment. Review of the clinical record on 1/25/23 found three missed visit notes by OT services on the following dates: 8/30/22 (patient not feeling well), 9/12/22 (patient hospitalized 9/12/22 through 9/14/22), and 9/19/22 (patient request). On 9/20/22, a communication note documented the patient requested to be discharged from the Agency for reasons unknown. From 8/29/22 through 9/19/22, minus the three hospitalization days noted above, OT services had 19 days to perform the evaluation and treatment of the patient, but did not. No additional attempts, patient refusal or physician notification were found in the medical record stating that OT services were not provided as ordered. MR #8: The patient's start of care (SOC) was 10/6/22) with diagnoses that included chronic atrial fibrillation, hypertensive heart disease with heart failure, chronic kidney disease, and diabetes-type 2. The POC on 10/6/22, ordered OT services the week effective 10/10/22 for evaluation and treatment. Review of the clinical record on 1/26/23 found a communication note dated 10/7/22 of a missed visit per patient request by OT services. Further review found no additional attempts by OT to evaluate and treat the patient. There was no documentation to indicate the patient or care giver had declined or delayed OT services and no documentation that the physician was informed that OT services were not provided as ordered through the certification period ending on 12/4/22. These findings were reviewed with and acknowledged by the Administrator and Alternate Administrator during an interview on 1/27/23 at 11:35 AM. The Agency failed to provide services in accordance with physician orders.

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 interview, it was determined the Agency failed to ensure all treatments and services were administered only as ordered by the physician, and failed to ensure the plan of care was initiated prior to the provision of care and services for 1 (MR# 2) record, from a total of 8 sampled records reviewed, resulting in the potential for lack of ordered care, the rendering of unsafe, inappropriate, unauthorized care and poor patient outcomes. Findings include: Policy: Physician's Plan of Treatment/Change Orders undated stated, "The plan of treatment shall be developed within five days..., The Agency will provide care/services consistent with the plan of treatment." MR #2: The patient's start of care SOC was 1/14/23 with diagnoses that included total Left Hip Replacement, Hypertensive Disorder and Cerebral Palsy. During the Entrance Conference on 1/24/23 at 10:45 a.m., a request was made to conduct a home visit for this patient. Adm #2 reported that a visit was scheduled for today (1/24/23). A request was made to review the patient's POC prior to the visit to which Adm #2 reported, "I'm not going to lie to you, but there is no POC." The referral for home care was dated 1/12/23 and ordered Skilled Nursing, Physical Therapy and Occupational Therapy services to be provided. A list of patient medications accompanied the referral as well as a detailed history of the patient's health status. The Agency failed to ensure the Plan of Care was developed within 5 days that guided the course of care, in accordance with the Agency's policy. These findings were reviewed with and acknowledged by Adm #1 and Adm #2 at the time of discovery.

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 document review and interview, the Agency failed to ensure the Physician was promptly notified of a change in clinical status for 2 (MR#'s 4, 6) patients, and failed to ensure the Physician was promptly notified of adverse drug interactions in 1 (MR# 8) record, from a total of 8 sampled records reviewed, resulting in the Physician not having essential information to address the needs of the patient and the potential for poor patient outcomes. Findings include: Agency Policy: "Medication Management" III.17 (undated) stated, "The medications will be reviewed for potential adverse effects, …significant drug interactions, duplicate drug therapy, and for patient non-compliance with drug therapy. The admitting clinician or the nurse reviewing the profile will contact the patient’s physician immediately if there are any questions or concerns regarding the medications the patient is taking." MR #6: The start of care (SOC) date was 8/26/22 with diagnoses which included hypertensive heart disease with heart failure, abrasions to right and left lower legs, and rheumatoid arthritis. The SOC comprehensive assessment documented the patient was "hospitalized on 8/16/22 for muscle weakness and worsening BLE (bilateral lower extremity) edema (swelling) that began in May. Patient was diagnosed with acute systolic heart failure." During record review on 1/25/23, the Plan of Care (POC) ordered skilled nursing (SN) at a visit frequency of once-a-week times three weeks, followed by one visit every other week times three weeks, and one PRN (as needed) visit for cardiac dysfunction. The POC stipulated the physician was to be notified of "Weight greater than (>) 136 lbs. or less than ( SN documented on the second home visit on 8/31/22, the patient's lower leg edema was +2 (+4 is the maximum) and the patient's weight was left blank. On the third visit (9/6/22), SN documented the patient's lower leg edema was +4 and the patient's weight was again, left blank. The patient was transferred to the hospital on 9/12/22 due to fluid overload. No evidence was found that the physician was notified of the significant change in condition which was indicative of fluid overload. These findings were reviewed with and acknowledged by the Administrator and Alternate Administrator during an interview on 1/27/23 at 11:30 AM. The Agency failed to notify the physician of significant clinical findings which led to a poor outcome. MR #8: The patient's start of care (SOC) was 10/6/22) with diagnoses that included chronic atrial fibrillation, hypertensive heart disease with heart failure, chronic kidney disease, and diabetes-type 2. On 1/26/23, review of the comprehensive assessment drug review performed by skilled nursing (SN) noted under section M2001, that issues were found during the review. The issues were as follow: "Allergies and duplicate therapies noted." However, further review found the physician was notified of these concerns on 10/28/22 at 8:23 PM., 22 days after the SOC review. These findings were reviewed with and acknowledged by the Administrator and Alternate Administrator during an interview on 1/27/23 at 11:15 AM. The Agency failed to follow its policy to immediately contact the physician with the above concerns. MR #4: The patient's start of care was 8/26/23 with diagnoses that included Hypertensive Heart Disease with Heart Failure and Urinary Retention requiring indwelling urinary catheter. The referral for home care ordered Skilled Nursing and Physical Therapy services to be provided. During the record review on 1/25/23 and 1/26/23, it was noted that the Plan of Care (POC) specified the following reportable parameters in which to notify the Physician: Notify Physician of pulse lower than (<) 60. During the review of the patient's course of care, it was noted that the patient had low pulse rates on the following dates: 8/31/22-51, 9/6/22-55, 11/16/22-50, 12/19/22-53, 1/19/23-53. There was no documented evidence that the Physician had been promptly notified of the patient's decreased pulse rates. These findings were reviewed with and acknowledged by the Administrator and Alternate Administrator during an interview on 1/27/23 at 9:35 a.m.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to coordinate the delivery of skilled nursing (SN), physical therapy (PT), and occupational therapy (OT) services for 1 (MR #6) of 5 records reviewed in which more than one discipline was ordered to provide care, out of a total sample of 8 records reviewed. This practice resulted in unmet personal care needs and a poor clinical outcome for this patient. Findings include: MR #6: The start of care (SOC) date was 8/26/22 with diagnoses which included hypertensive heart disease with heart failure, abrasions to right and left lower legs, and rheumatoid arthritis. The SOC comprehensive assessment documented the patient was "hospitalized on 8/16/22 for muscle weakness and worsening BLE (bilateral lower extremity) edema (swelling) that began in May. Patient was diagnosed with acute systolic heart failure." During record review on 1/25/23, the Plan of Care (POC) ordered skilled nursing (SN) at a visit frequency of once-a-week times three weeks, followed by one visit every other week times three weeks, and one PRN (as needed) visit for cardiac dysfunction. PT services were ordered for 1wk1 (once a week for one week), 2wk3, and 1wk1. OT services were ordered to evaluate and treat effective the week of 8/29/22. On 1/26/23, record review noted the following clinical entries: On 8/30/22, OT documented, “Patient canceled OT evaluation due to not feeling well and swelling in her legs.” On 9/9/22, PT documented, “CG (Caregiver) called to cancel today’s visit citing pt (patient) is exhausted from morning appt. and she was going back to bed.” In between the 8/30/22 and 9/9/22 visits above, SN’s visit note on 8/31/22 documented the patient's lower leg edema was +2 (+4 is the maximum) and the patient's weight was left blank. On the next visit (9/6/22), SN documented the patient's lower leg edema was +4 and the patient's weight was again left blank. The patient was transferred to the hospital on 9/12/22 due to fluid overload. No evidence was found in the clinical record of the disciplines above communicating with each other concerning the clinical findings in conjunction with her recent hospitalization on 8/16/22 of the elevated risks of heart failure exacerbation (worsening). No documentation was found of the physician being notified for potential interventions to prevent fluid overload and subsequent hospitalization. These findings were reviewed with and acknowledged by the Administrator and Alternate Administrator during an interview on 1/27/23 at 11:20 AM. The Agency failed to coordinate care among the ordered skilled disciplines to comprehensively meet the clinical needs of the patient, which led to a poor outcome.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, it was determined that the agency failed to provide 2 (MR#'s 1, 2) of 3 patients observed during home visits, with a Medication Profile that included the names, dosages and frequencies of the patient's prescribed medications, in plain language, from a total of 8 sampled records reviewed, resulting in lack of direction for medication administration and the potential for improper use of medications. Findings include: Policy: "Medication Management" III.17 undated stated, A Medication Profile comprised of a list of al medications (including over the counter drugs), supplements, and herbal products that a patient is taking, shall be completed for each patient at the time of admission by the admitting clinician..., The medication profile will include the name of the drug, date ordered, dose, route of administration, frequency/time of administration, duration of therapy, action or effect, side effects, and contraindications. This profile will also serve as a tool for the purpose of patient/caregiver education." MR #1: The patient's start of care (SOC) was 1/21/23 with diagnoses that included Arterial Embolism and Chronic Congestive Heart Failure. During the clinical record review on 1/25/23 at 10:15 a.m., it was noted that Skilled Nursing (SN), Physical Therapy (PT) and Occupational Therapy (OT) services were ordered to be provided. On 1/24/23 at 1:00 p.m., a scheduled home visit was conducted with the Physical Therapist/Administrator. During a review of the patient's admission packet, it was noted that there was no Medication Profile in the patient's admission packet that listed the patient's prescribed medications, dosages and side effects. The patient was queried and expressed no knowledge of ever having a Medication list provided by the Agency. These findings were reviewed with and acknowledged by the Administrator and Alternate Administrator during an interview on 1/26/23 at 11:00 a.m. MR #2: The patient's SOC was 1/14/23 with diagnoses that included Left total Hip Replacement and Hypertensive Disorder. During the record review on 1/25/23 at 11:00 a.m., it was noted that SN, OT, and PT services were ordered to be provided. On 1/24/23 at 2:46 p.m., during a scheduled joint home visit with the Occupational Therapist/Alternate Administrator, it was noted that the patient's admission packet was void of a Medication Profile that listed all the patients prescribed medications. During the visit, the patient was queried, and expressed no knowledge of having a Medication list provided by the Agency. These findings were reviewed with and acknowledged by Adm #1 and Adm #2 during an interview on 1/26/23 at 11:25 a.m.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record review and interview, the Agency failed to ensure that the Quality Assessment and Performance Improvement data was used to monitor the effectiveness and safety of services provided with opportunities for improvement; and failed to ensure the Governing Body approved the program's frequency and detail of data collection, resulting in the potential for poor patient outcomes for all patients currently serviced and the Agency's 188 patients admitted in the past year (G644); failed to develop Performance Improvement activities, as part of the Agency's Quality Assessment Performance Improvement program, in order to track and trend adverse patient events, analyze the cause and implement preventive interventions, resulting in the potential for the rendering of substandard care and unmet care needs for all patients serviced by this Agency (G654); failed to measure the success of its performance improvement projects to ensure the improvements were sustained, resulting in the potential for unidentified health concerns and the rendering of substandard care and poor patient outcomes (G656); failed to develop a Quality Assessment Performance Improvement program that documented the annual quality improvement projects, the reasons for conducting these projects with measurable progress achieved on these projects for the 2022 calendar year, resulting in the Agency's inability to improve in patient care, health outcomes, patient safety, quality of care and the agency's performance (G658); failed to ensure the Agency had an active and functioning Quality Assessment and Performance Improvement program that addressed priorities for improved quality of care and patient safety and was evaluated for effectiveness, resulting in the potential to negatively affect the quality of care to all patients currently receiving services (G660). 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 §484.65 Quality Assessment Performance Improvement.

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, the Agency failed to ensure that the Quality Assessment and Performance Improvement data was used to monitor the effectiveness and safety of services provided with opportunities for improvement; and failed to ensure the Governing Body approved the program's frequency and detail of data collection, resulting in the potential for poor patient outcomes for all patients currently serviced and the Agency's 188 patients admitted in the past year. Findings include: On 1/26/23 at 11:55 a.m., the Administrator (Adm #1) was asked to provide the Agency's Quality Assessment and Performance Improvement (QAPI) documentation and evidence of data collection for review. Upon review of the requested information, it was noted that the agency failed to analyze their QAPI data in order to monitor the quality, effectiveness and safety of services and care provided to their patients, infection control and to identify opportunities for improvement. Additionally, there was no evidence that the Agency's Governing Body approved the frequency and detail of the QAPI data collected. These findings were reviewed with Adm #1 and the Alternate Administrator (Adm #2) during an interview on 1/26/23 at 1:08 p.m.

Track adverse patient events CFR(s): 484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. This STANDARD is not met as evidenced by: Based on interview and record review, it was determined the Agency failed to develop Performance Improvement activities, as part of the Agency's Quality Assessment Performance Improvement program, in order to track and trend adverse patient events, analyze the cause and implement preventive interventions, resulting in the potential for the rendering of substandard care and unmet care needs for all patients serviced by this Agency. Findings include: On 1/26/23 at 11:55 a.m., the Administrator (Adm #1) was asked for permission to review the Agency's QAPI (Quality Assessment Performance Improvement) program data, including their Performance Improvement Projects. Upon review, it was noted that there was no tracking, analyzing or implementation of preventive actions to decrease the number of adverse patient events and improve the quality and safety of patient care and outcomes. These findings were reviewed with and acknowledged by Adm #1 and the Alternate Administrator (Adm #2) during an interview on 1/26/23 at 1:08 p.m.

Improvements are sustained CFR(s): 484.65(c)(3) The HHA must take actions aimed at performance improvement, and, after implementing those actions, the HHA must measure its success and track performance to ensure that improvements are sustained. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to measure the success of its performance improvement projects to ensure the improvements were sustained, resulting in the potential for unidentified health concerns and the rendering of substandard care and poor patient outcomes. Findings include: On 1/26/23 at 11:55 a.m., during a review of the Agency's Quality Assessment Performance Improvement (QAPI) data, specifically, Performance Improvement Projects, it was noted that the Agency only listed Projects to be undertaken. There was no additional information available for review. The Agency failed to measure the success of its performance improvement projects to ensure the improvements were sustained. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Alternate Administrator (Adm #2) during an interview on 1/26/23 at 1:08 p.m.

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on interview and record review, it was determined the Agency failed to develop a Quality Assessment Performance Improvement program that documented the annual quality improvement projects, the reasons for conducting these projects with measurable progress achieved on these projects for the 2022 calendar year, resulting in the Agency's inability to improve in patient care, health outcomes, patient safety, quality of care and the agency's performance. Findings include: On 1/26/23 at 11:55 a.m., the Administrator was asked for permission to review the Agency's QAPI (Quality Assessment Performance Improvement) projects for the 2021 and 2022 calendar years. The Agency presented a document with a section titled "Performance Improvement." Under this section were "Current Projects" such as Reporting discrepancies to Physician and Oasis submission timely. Further, it was unclear which year these projects had been decided upon. There was no documented rational for conducting these projects and no measurable progress achieved on these projects. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and the Alternate Administrator (Adm #2) during an interview on 1/26/23 at 1:08 p.m.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based record review and interview, it was determined the Governing Body failed to ensure the Agency had an active and functioning Quality Assessment and Performance Improvement program that addressed priorities for improved quality of care and patient safety and was evaluated for effectiveness, resulting in the potential to negatively affect the quality of care to all patients currently receiving services. Findings include: On 1/26/23 at 1:08 p.m., during a review of the Agency's Quality Assessment and Performance Improvement (QAPI) documents with the Administrator (Adm #1) and Alternate Administrator (Adm #2), a request was made to review the Governing Body meeting minutes to ensure the provision of oversight and approval of the Agency's QAPI activities. Both Adm #1 and Adm #2 acknowledged there were meeting minutes available for review. The Agency failed to ensure a functioning Governing body provided oversight over its QAPI program. These findings were reviewed with and acknowledged by Adm #1 and Adm #2 at the time of discovery.

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 observation, record review and interview, the Agency failed to coordinate an agency-wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases as a part of the Agency's Quality Assessment Performance Improvement program and; failed to develop a method of screening visitors and all staff employed by this Agency, prior to the provision of care and services, resulting in the potential development and spread of a contagious viral infection between agency staff and all 188 patients currently serviced by this Agency. Findings include: On 1/14/23 upon arrival to the agency, there were no signs that instructed visitors on the protocol upon entrance into the agency's suite. Upon entering, there was no visitor screening process in place. During the Entrance Conference, the Alternate Administrator (Adm #2) was queried about the process for screening field staff prior to the provision of care and reported, "They (staff) screen themselves. They send their screening in every payroll. I'll show you." On 1/24/23 at 1:00 p.m., a scheduled home visit was conducted with the Physical Therapist/Administrator (Adm #1). During the visit, Adm #1 took the patient's temperature and then took the patient's wife's temperature. Adm #1 did not assess her own temperature prior to providing care. On 1/24/23 at 2:46 p.m., a scheduled home visit was conducted with the Occupational Therapist (Adm #2). During the visit, Adm #2 was observed repeatedly scanning his left forearm with a digital. It was then stated that he (Adm #2) was checking his temperature. Adm #2 failed to screen himself prior to the provision of care and prior to entering the patient's home. These findings were reviewed with Adm #1 and Adm #2 upon completion of the home visits and again during interviews on 1/26/23 at 11:30 a.m. On 1/26/23 at 2:00 p.m., the Agency's Quality Assessment (QAPI) and Infection Control data was reviewed with Adm #1 and Adm #2. A request was made to review the meetings minutes for the topics discussed. Adm #1 and Adm #2 both acknowledged that there were no meeting minutes were available for review. There was no documented evidence that the Agency had included Infection Control as part of it's QAPI program.

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 document review and interview, it was determined that the Agency failed to ensure the skilled nursing followed accepted standards of practice in assuming responsibility for the care of 1 (MR #6) of 5 patients with heart failure, from a total of 8 sampled patient records reviewed (see G704); failed to ensure the Registered Nurse performed baseline assessments and re-assessments of the patient's health status and needs in 1 (MR #4) record of a patient with a diagnosis of congestive heart failure and Diabetes Mellitus, from a total of 8 sampled records reviewed, resulting in the potential for unidentified health concerns, decline in physiological functioning, and poor patient outcomes (See G706); failed to ensure the skilled nursing assisted the physician in the development of the plan of care for 1 (MR #5) of 6 records reviewed in which nursing services were ordered (see G708); failed to document patient weights concerning congestive heart failure in 1 (MR's #6) of 5 records with heart failure, from a total of 8 sampled records reviewed (see G710); and failed to ensure physical therapy provided appropriate oversight of the physical therapy assistant in 1 (MR#7) of 7 records with therapy services ordered, from a total sample of 8 records reviewed (see G724). The cumulative effect of these systemic failures resulted in a poor outcome and the home health Agency's inability to ensure the provision of quality health care in a safe environment for the condition of participation of 42 CFR 484.75, 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 notify the physician of a significant change in the patient's clinical status in 1 (MR# 6) of 5 records reviewed with congestive heart failure out of out of a total sample of 8 records reviewed, resulting in a poor patient outcome and unmet clinical care needs. Findings include: MR #6: The start of care (SOC) date was 8/26/22 with diagnoses which included hypertensive heart disease with heart failure, abrasions to right and left lower legs, and rheumatoid arthritis. The SOC comprehensive assessment performed by RN#1 documented the patient was "hospitalized on 8/16/22 for muscle weakness and worsening BLE (bilateral lower extremity) edema (swelling) that began in May. Patient was diagnosed with acute systolic heart failure." During record review on 1/25/23, the Plan of Care (POC) ordered skilled nursing (SN) at a visit frequency of once-a-week times three weeks, followed by one visit every other week times three weeks, and one PRN (as needed) visit for cardiac dysfunction. The POC stipulated the physician was to be notified of "Weight greater than (>) 136 lbs. or less than (<) 127 lbs., and SN to instruct patient on measures to detect and alleviate edema. RN#1 documented on the second home visit on 8/31/22, that the patient's lower leg edema was +2 (mild) and the patient's weight was left blank. The third visit on 9/6/22, RN#1 documented the patient's lower leg edema had increased to +4 (severe) and the patient's weight was again left blank. The patient was transferred to the hospital on 9/12/22 due to fluid overload. No evidence was found that the physician was notified of the significant change in condition which was indicative of fluid overload. These findings were reviewed with and acknowledged by the Administrator and Alternate Administrator during an interview on 1/27/23 at 11:30 AM. The Agency failed to ensure SN applied professional standards of practice to meet the needs of the patient which led to a poor outcome of hospitalization..

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined that the Agency failed to ensure the Registered Nurse performed baseline assessments and re-assessments of the patient's health status and needs in 1 (MR #4) record of a patient with a diagnosis of congestive heart failure and Diabetes Mellitus, from a total of 8 sampled records reviewed, resulting in the potential for unidentified health concerns, decline in physiological functioning, and poor patient outcomes. Findings included: MR #4: The patient's start of care was 8/26/22 with diagnoses that included Hypertensive Heart Disease with Heart Failure, Urinary Retention and Diabetes Mellitus. The Plan of Care (POC) ordered Skilled Nursing (SN) and Physical Therapy (PT) services to be provided. The patient was discharged from PT services on 10/12/22. On 1/25/23 and 1/26/23 during the clinical record review, the Initial Comprehensive Assessment dated 8/26/22 documented, "Severe edema lt. (left) leg more than rt. (right)..., History of CHF (Congestive Heart Failure), Diabetes Mellitus." The SN failed to document baseline measurements of edema. Further, there was no actual baseline weight and no baseline blood sugar noted in the assessment. Further review of the clinical record which included certification periods 8/26/22 - 10/24/22; 10/25/22 - 12/23/22; and 12/24 to present date 1/27/23 revealed that the SN failed to assess the patient's weights, blood sugars and lower extremity edema. There was no documented evidence that the SN conducted baseline assessments and re-assessments of the patient's health status. These findings were reviewed with the Administrator (Adm #1) and Alternate Administrator (Adm #2) during an interview on 1/27/23 at 9:35 a.m. During the interview, Adm #2 reported, "They (SN) have disposable tape measurers and they should be measuring edema." During the Entrance Conference on 1/24/23 at 10:45 a.m., Adm #2 stated the disciplines have scales to weigh the patient and could also pick up a scale at one of the Agency's drop sites. However, during this interview, Adm #2 reported, "The disciplines haven't been taking scales into the patient's homes since Covid."

Development and evaluation of plan of care CFR(s): 484.75(b)(2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure Skilled Nursing (SN) assisted the physician in evaluating and helped to develop the plan of care to meet the patient’s needs for 1 (MR #5) of 5 records reviewed with congestive heart failure, from a total sample of 8 records reviewed, resulting in the potential for poor patient outcomes. Findings include: Agency Policy: "Physician's Plan of Treatment/Change Orders" III.6 (undated) stated, "The physician's plan of treatment (Medicare's Plan of care) is an individualized plan for care and treatment prepared by the patient's physician with assistance from the nurse... The plan of treatment shall include but not limited to: All pertinent (known) diagnoses, Safety precautions, Measurable outcomes, and goals..." MR# 5: This 69-year-old patient was admitted to agency on 11/10/22 for diagnoses which included cellulitis of right and left lower limbs, pressure ulcer of sacral region-stage 2, congestive heart failure (CHF) and chronic kidney disease. On 1/25/23, review of the initial comprehensive assessment found under “Cardiac Status”, that the patient was “recently hospitalized” for a heart attack (date unknown). No documentation was found if and how this impacted the patient’s heart failure and subsequent monitoring needs. Further review of the patient's Plan of Care (POC) found no parameters (i.e., patient weight or limb circumference measurements) to monitor exacerbation (worsening) of the patient's CHF symptoms. Under skilled nursing (SN) interventions, no examples of specific, detailed instructions/interventions concerning CHF patient education were found within the POC. Further, SN goals which addressed and detailed CHF management that would be measurable were not found. These findings were reviewed with and acknowledged by the Administrator and Alternate Administrator during an interview on 1/27/23 at 11:05 AM.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the skilled nurse provided services ordered within the patient's Plan of Care (POC) in 1 (MR# 6) of 5 records reviewed with congestive heart failure out of out of a total sample of 8 records reviewed, resulting in a poor patient outcome and unmet clinical care needs. Findings include: MR #6: The start of care (SOC) date was 8/26/22 with diagnoses which included hypertensive heart disease with heart failure, abrasions to right and left lower legs, and rheumatoid arthritis. The SOC comprehensive assessment documented the patient was "hospitalized on 8/16/22 for muscle weakness and worsening BLE (bilateral lower extremity) edema (swelling) that began in May. Patient was diagnosed with acute systolic heart failure." During record review on 1/25/23, the Plan of Care (POC) ordered skilled nursing (SN) at a visit frequency of once-a-week times three weeks, followed by one visit every other week times three weeks, and one PRN (as needed) visit for cardiac dysfunction. The POC stipulated the physician was to be notified of "Weight greater than (>) 136 lbs. or less than (<) 127 lbs., and SN to instruct patient on measures to detect and alleviate edema. SN documented on the second home visit on 8/31/22, the patient's lower leg edema was +2 (+4 is the maximum) and the patient's weight was left blank. Additionally, no documentation was found within the clinical note of SN providing instructions detailing edema alleviating measures to the patient. Further, no documentation was found of what the patient's ability or comprehension was to recognize exacerbation of CHF symptoms, and when to seek urgent health care follow-up. On the third visit (9/6/22), SN documented the patient's lower leg edema was +4 and the patient's weight was again left blank. The patient was transferred to the hospital on 9/12/22 due to fluid overload. No evidence was found that the physician was notified of the significant change in condition as stipulated in the POC with the intended purpose that SN would perform monitoring the patient's weight for CHF exacerbation (worsening) concerning fluid overload. These findings were reviewed with and acknowledged by the Administrator and Alternate Administrator during an interview on 1/27/23 at 11:30 AM. The Agency failed to ensure SN followed instructions on the patient's POC which could have potentially avoided a poor outcome and subsequent hospitalization.

Supervise skilled professional assistants CFR(s): 484.75(c) Standard: Supervision of skilled professional assistants. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to ensure physical therapy (PT) provided appropriate oversight and communication with the physical therapy assistant (PTA) in 1 (MR#7) of 7 records reviewed in which the patient had PTA services assigned to provide care, from a total sample of 8 records reviewed, resulting in the potential for a poor patient outcome. Findings include: MR# 7: The start of care (SOC) date for this patient was 3/5/22 for diagnoses which included hypertensive heart disease with CHF, chronic kidney disease, and diabetes-type 2. Record review on 1/26/23, noted PT services was the lone discipline assigned to the case. The Plan of Care (POC) ordered PT services to “assess patient for signs and symptoms of CHF (congestive heart failure)” and to notify physician of weight gains greater than 2 lbs. (indicative of fluid overload). In addition, the POC stipulated for PT services manage and to notify the physician of if fasting blood sugar was greater than 200 mg/dL or random blood sugar greater than 300 mg/dL. Further record review found 8 of 8 home visits by the PTA from 3/9/22 through 4/2/22, had no entries or documentation of any patient weights or blood sugar values to evaluate if the patient remained stable. No evidence was found in the medical record of the PT inquiring why the PTA had failed to follow to interventions stipulated in the POC. The PT supervisory note on 4/2/22 used to evaluate the PTA care furnished had documented the PTA was “excellent” in following the patient’s POC. No follow-up measures were found in the record of the PT having corrected the PTA's deficient documentation concerning the monitoring of the patient's primary and secondary diagnoses. These findings were reviewed with and acknowledged by the Administrator and Alternate Administrator during an interview on 1/27/23 at 11:25 AM. The PT failed to ensure the PTA's documentation followed the patient's POC as directed.

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 the Discharge Summary was complete, detailed the course of care and status at the time of discharge and forwarded to the Physician within 5 days from the date of discharge, for 2 (MR #3, 4), records in which the patient was discharged from the Agency's care or services, from a total of 8 records reviewed, resulting in the potential for unidentified continuing health care concerns and unmet care needs. Findings include: MR #3: The patient's start of care was (SOC) 8/4/22 with diagnoses that included Knee Replacement, Laceration Right Lower Extremity, Diabetes Mellitus and Hemiplegia. On 1/25/23 at 2:40 p.m., during the record review, it was noted that Physical Therapy (PT) services were ordered to be provided. The patient was discharged from the Agency's services on 10/14/22. Further review revealed that the Discharge Summary was sent to the Physician on 10/24/22 (10 days after the date of discharge). The Agency failed to ensure the discharge summary was forwarded to the Physician within 5 days of the date of discharge. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Alternate Administrator (Adm #2) during an interview on 1/26/23 at 12:00 p.m. MR #4: The patient's SOC was 8/26/22 with diagnoses that included Hypertensive Heart Disease, Urinary Retention and Diabetes Mellitus. During the record review on 1/25/23, it was noted that the patient was ordered to receive PT services. The patient discharged from PT services on 10/12/23. Upon further review, the PT Discharge Summary dated 10/12/23 was void of a summary that detailed the course of care provided with responses and the patient's health status at the time of discharge. These findings were reviewed with and acknowledged by Adm #1 and Adm #2 during an interview on 1/27/23 at 9:35 a.m.