Pegasus Home Health Care, Inc.

“Condition of Participation: Patient rights. CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient’s rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This Condition is not met as evidenced by: Based on interview, and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to ensure the Condition of Participation (CoP-a set of minimum professional standards all home health agencies must meet to participate in Medicare [federal health insurance for anyone age 65 and older, and some people under 65 with certain disabilities or conditions] and Medicaid [a joint federal and state program that provides health coverage for some people with limited income and resources] government programs) for Patient rights was met as follows: The HHA failed to ensure a safe and appropriate discharge process for two of seventeen sampled patients (Patient 6 and Patient 17) by failing to: a. Ensure Patient 6 was provided with the correct colostomy (a surgical procedure that brings one end of the large intestine out through the abdominal wall to allow waste to leave the body) supplies needed for twice weekly colostomy changes prior to discharge on 4/22/2026. b. Ensure a physician’s order for discharge was obtained for Patient 17, who required biweekly blood draw for an immune disorder (occur when the body’s defense network malfunctions) via peripherally inserted central catheter (PICC, a thin, flexible tube that delivers treatments through a vein) and weekly PICC line dressing changes, prior to discharging Patient 17 on 12/23/2025. c. Ensure that Patient 17, who required home health agency services for biweekly blood draws and PICC line dressing changes, was accepted or transferred to a new home health agency who could meet Patient 17’s needs prior to discharging Patient 17 on 12/23/2025. These failures resulted in Patient 6 receiving the incorrect supplies for colostomy care upon discharge, increasing the risk of infection and sepsis; and a lack in continuity of care for Patient 17 increasing the risk for complications such as PICC line infection, sepsis (a life-threatening reaction to an infection), and occlusion (partial or complete blockage of a blood vessel or cavity) that could require hospitalization and potentially result in death if left untreated. (Refer to G454). This systemic practice resulted in the failure of the HHA to deliver statutorily mandated (a legal obligation established by a statute or law) compliance of Federal regulations for patient rights to ensure provision of highest quality patient care and services to patients certified to receive home health services. The HHA failed to ensure that services were provided in accordance with the individualized plan of care for one of seventeen sampled patients (Patient 6). This failure had the potential to negatively impact on the patient’s health status by not providing the timely and appropriate services identified as necessary in the patient’s plan of care. (Refer to G436).”

“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 observation, interview, and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to ensure the Condition of Participation (CoP-a set of minimum professional standards all home health agencies must meet to participate in Medicare [Federal health insurance for anyone age 65 and older, and some people under 65 with certain disabilities or conditions] and Medicaid [a joint Federal and State program that provides health coverage for some people with limited income and resources] government programs) for Comprehensive Assessment of Patients was met as follows: The HHA failed to conduct a complete and accurate review of all medications and failed to update the medication profile (Up-to-date record of all the medicines a patient is currently taking) with the medications currently being used by three of seventeen sampled patients (Patient 1, Patient 2, and Patient 10). This deficient practice placed these patients at risk for medication errors, omissions, duplications, and adverse drug reactions (An unintended, harmful effect of a medication taken at the correct dose) due to the absence of an accurate and up‑to‑date medication profile. (Refer to G536). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily (written law) mandated compliance with Federal regulation for Comprehensive Assessments of the patients to ensure the highest quality of care were being provided to patients certified to receive the HHA benefits.”

“Discharge Planning CFR(s): 484.58 Condition of Participation: Discharge planning. This Condition is not met as evidenced by: Based on interview, and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to ensure the Condition of Participation (CoP-a set of minimum professional standards all home health agencies must meet to participate in Medicare [Federal health insurance for anyone age 65 and older, and some people under 65 with certain disabilities or conditions] and Medicaid [a joint Federal and State program that provides health coverage for some people with limited income and resources] government programs) for Discharge Planning was met as follows: The HHA failed to assist patient and caregiver in selecting a home health agency that would meet goals of care and treatment preference to one of 17 sampled patients (Patient 17). This failure resulted in lack of continuity of care for Patient 17 increasing the risk for complications such as PICC line infection, sepsis, and occlusion (partial or complete blockage of a blood vessel or cavity) that could require hospitalization and potentially result in death if left untreated. (Refer to G562). This systemic practice resulted in the failure of the HHA to deliver statutorily mandated (a legal obligation established by a statute or law) compliance of Federal regulations for discharge planning to ensure provision of highest quality patient care and services to patients certified to receive home health services.”

“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 observation, interview, and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to ensure the Condition of Participation (CoP-a set of minimum professional standards all home health agencies must meet to participate in Medicare [Federal health insurance for anyone age 65 and older, and some people under 65 with certain disabilities or conditions] and Medicaid [a joint Federal and State program that provides health coverage for some people with limited income and resources] government programs) for care planning, coordination of services, and quality of care was met as follows: a. The Home Health Agency (HHA) failed to follow the plan of care (is a written outline of the services and treatments a patient needs, created and approved by the physician to guide the care provided by the agency) for one of seventeen sampled patients (Patient 17) by failing: To provide the CHHA (A Certified Home Health Aide (CHHA, is a professional that authorized to provide personal care services in the home, including assistance with activities of daily living, in accordance with the patient’s plan of care and under the supervision of licensed clinical staff) services ordered in Patient 17’s plan of care. This failure had a potential to result in Patient 17 will have poor hygiene, decreased mobility support, and increased vulnerability to complications such as skin irritation, pressure injuries, or skin breakdown. (Refer to G572). b. The HHA failed to ensure a physician’s order was obtained and recorded in the plan of care for one of seventeen sampled patients (Patient 10). For Patient 10, the HHA did not have a physician’s order regarding the use of the Fiasp FlexTouch insulin pen (is a pre-filled, disposable insulin pen used to manage blood sugar levels in adults and children with diabetes (a chronic condition where the body does not produce enough insulin (a hormone produced by the pancreas that helps regulate blood sugar levels) or cannot properly use the insulin it produces, leading to high blood sugar levels), and contains a rapid-acting insulin that starts working very quickly, usually within 10–20 minutes to control blood sugar spikes at mealtimes) subcutaneous (situated or occurring directly under the skin, specifically within the fatty tissue layer located between the skin and the muscle), including the indication, dose, route, frequency, time of administration, and parameters for when the insulin should or should not be administered. This information was not incorporated into the patient’s plan of care as required. This failure placed Patient 10 at increased risk for potential complications such as hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar). (Refer to G576). c. The HHA failed to ensure effective communication with the primary physician regarding the plan of care for two of seventeen sampled patients (Patient 10 and Patient 17) by failing to: Communicate with Patient 10’s primary care physician (MD 2) regarding the use of the Fiasp FlexTouch insulin pen, subcutaneous, including the indication, dose, route, frequency, time of administration, and instructions for when the insulin should or should not be administered. Notify Patient 17’s primary physician (MD 1) that the patient was receiving care and services from the HHA. Notify MD 1 that Patient 17 was discharged without a transfer being arranged to another home health agency. This failure had the potential to result in placing Patient 10 at increased risk for hypoglycemia (low blood sugar level) and hyperglycemia (high blood sugar level). Patient 17 was placed at increased risk for delays in essential medical oversight, missed follow up care, and gaps in continuity of services, which could contribute to preventable health deterioration or adverse health outcomes (any negative or undesirable effects on a person’s physical, mental, or social well-being that can range from temporary harm to permanent disability or death) (Refer to G602). d. The HHA failed to coordinate care delivery and involve the patient or primary caregiver (PCG) in the care planning process for two of seventeen sampled patients (Patient 10 and Patient 17). For Patient 10, the HHA did not engage the patient or PCG in discussions regarding the insulin regimen, including the instructions for use, administration parameters, and the physician’s required orders, resulting in a lack of coordinated and informed participation in the patient’s care. For Patient 17, the HHA did not notify or involve the patient or PCG on the changes made to the discharge plan and the date the Patient 17 would be discharged from home health services. This deficient practice limited the patients’ and caregivers’ ability to participate in care decisions and compromised the continuity and coordination of services necessary to meet their individualized needs. (Refer to G608). The cumulative effect of these systemic problem resulted in the failure of the HHA to deliver statutorily mandated (a legal obligation established by a statute or law) compliance of Federal regulations for care planning, coordination of services, and quality of care to ensure provision of highest quality patient care and services to patients certified to receive home health services.”

“Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This Condition is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to ensure the Condition of Participation (CoP-a set of minimum professional standards all home health agencies must meet to participate in Medicare [federal health insurance for anyone age 65 and older, and some people under 65 with certain disabilities or conditions] and Medicaid [a joint federal and state program that provides health coverage for some people with limited income and resources] government programs) for Clinical Records was met as follows: The HHA failed to ensure that patients’ clinical records contained complete and accurate physician’s orders and documented clinical notes reflecting communication with the physician for two of seventeen sampled patients (Patient 10 and Patient 17). For Patient 10, the HHA failed to obtain a physician’s order from the patient’s primary care physician (MD 2) and failed to transcribe the order into the patient’s Plan of Care for the use of the Fiasp FlexTouch insulin pen (is a pre-filled, disposable insulin pen used to manage blood sugar levels in adults and children with diabetes (a chronic condition where the body does not produce enough insulin (a hormone produced by the pancreas that helps regulate blood sugar levels) or cannot properly use the insulin it produces, leading to high blood sugar levels), and contains a rapid-acting insulin that starts working very quickly, usually within 10–20 minutes to control blood sugar spikes at mealtimes) subcutaneous (situated or occurring directly under the skin, specifically within the fatty tissue layer located between the skin and the muscle), with contain required elements of the insulin order, including indication, dose, route (subcutaneous), frequency, time of administration, and parameters for when the insulin should or should not be administered. For Patient 17, the HHA failed to ensure the clinical record contained documented evidence of communication with the physician regarding the patient’s discharge. This failure had the potential to result in incomplete or inaccurate patient care planning, delays in treatment, medication errors, and inadequate continuity of care. (Refer to G1012). The HHA failed to provide documented evidence that the discharge summary was sent to the primary care practitioner or other health care professional responsible for the patient’s post discharge care within five (5) business days of discharge for one of seventeen sampled patients (Patient 17) This deficient practice had the potential to compromise Patient 17’s continuity of care, delays in follow-up services, and negatively impact the Patient 17’s overall health outcomes. (Refer to 1014). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily (written law) mandated compliance with Federal regulation for clinical records to ensure the highest quality of care were being provided to patients certified to receive the HHA benefits. 1”

“Discharge Planning CFR(s): 484.58(a) Standard: Discharge planning. An HHA must develop and implement an effective discharge planning process. For patients who are transferred to another HHA or who are discharged to a SNF, IRF or LTCH, the HHA must assist patients and their caregivers in selecting a post-acute care provider by using and sharing data that includes, but is not limited to HHA, SNF, IRF, or LTCH data on quality measures and data on resource use measures. The HHA must ensure that the post-acute care data on quality measures and data on resource use measures is relevant and applicable to the patient’s goals of care and treatment preferences. This Standard is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutic services to a patient’s personal residence) failed to assist patient and caregiver in selecting a home health agency that would meet goals of care and treatment preference to one of 17 sampled patients (Patient 17). This failure resulted in lack of continuity of care for Patient 17 increasing the risk for complications such as PICC line infection, sepsis, and occlusion (partial or complete blockage of a blood vessel or cavity) that could require hospitalization and potentially result in death if left untreated. Findings: During a review of Patient 17’s clinical record titled “Patient Information”, the “Patient Information” indicated Patient 17 had a start of care (SOC) of 11/7/2025, with diagnoses that included cytokine storm (a severe, dangerous overreaction of the immune system where the body releases too many signaling proteins [cytokines] into the blood too quickly. Instead of just fighting an infection, this flood of proteins causes massive inflammation that can damage tissues and lead to organ failure) and immune disorder (a malfunction where the body’s immune system—which normally fights germs—does not work properly). During a review of Patient 17’s clinical record titled “Plan of Care (POC, written document developed for each individual by the agency using a person-centered approach that describes the supports, services, and resources provided or accessed to address the needs of the individual), dated 11/7/2025. The POC indicated Patient 17 would be discharged when medical condition is stable and Patient 17 is no longer in need of skilled nursing services. During a concurrent interview and record review on 5/7/2026 at 11:22 am., with the Director of Patient Care Services Designee (DPCS Designee), Patient 17’s clinical record titled “SOC report” dated 11/7/2025 was reviewed. The SOC report indicated Patient 17 was admitted to HHA services for blood draw (a medical procedure where a small amount of blood is taken from a vein, for laboratory testing) and peripherally inserted central catheter (PICC, a thin, flexible tube that delivers treatments through a vein) line dressing changes for management of Patient 17’s immune disorder. The DPCS Designee stated that PICC line dressings should be changed every one to two weeks to prevent infection which could lead to sepsis and rehospitalization. During a concurrent interview and record review on 5/7/2026 at 12:36 pm., with the DQM, Patient 17’s “Communication Note”, dated 12/18/2025 was reviewed. The “Communication Note” indicated that Case Manager 2 (CM 2) informed Patient 17’s primary caregiver (PCG 2) that the agency was unable to accommodate Patient 17’s request for a blood draw before 8 am. The DQM stated that the Communication Note did not indicate that CM 2 notified PCG 2 of the date of Patient 17’s planned discharge. During an interview on 5/7/2026 at 2:10 pm., with the DPCS Designee, the DPCS designee stated the HHA did not provide information to Patient 17 and PCG 2 related to other HHA services of Patient 17’s area of residence to continue providing skilled nursing services that included weekly PICC line dressing change and blood draw for laboratory testing every two weeks. During an concurrent interview and record review on 5/11/2026 at 9:30 am., with Registered Nurse 2 (RN 2), Patient 17’s clinical record titled “OASIS (Outcome and Assessment Information Set, is a group of standard data elements designed to enable systematic comparative measurement of home health care patient outcomes at two points in time in adult skilled Medicare and Medicaid, non-maternity home health care patients) Discharge”, dated 12/23/2025 was reviewed. The OASIS Discharge indicated that discharge instructions were provided to Patient 17 and PCG 2. RN 2 stated that the discharge instructions provided to Patient 17 and PCG 2 included education on signs and symptoms of infection at the PICC line site and encouraged Patient 17 to follow up with their primary physician (MD 1). RN 2 also stated that no information was provided regarding other HHA that service Patient 17’s area of residence. During a concurrent interview and record review on 5/12/2026 at 12:46 pm., with the DQM, Patient 17’s “RN Visit”, dated 11/11/2025, 11/28/2025, 11/25/2025, 11/28/2025, 12/11/2025 and 12/22/2025, was reviewed, the “RN Visit” indicated Patient 17 will be discharge at the end of POC. The “RN Visit” did not contain information discharge instructions provided to Patient 17 and PCG 2. The DQM stated that if the discharge date was established for Patient 17, the discharge date should be indicated in the “RN Visit” note and the discussion regarding the planned discharged. During a review of HHA’s P&P, titled “Discharge Planning”, revised in November 2024. The P&P indicated: - Patients will not be discharged without appropriate preparation. The patient’s continuing care needs will be assessed on an ongoing basis and at discharge. Information will be provided to assist the patient in planning his/her discharge, including referral and transfer. During a review of HHA’s P&P, titled “Discharge Criteria and Process”, revised in November 2014. The P&P indicated: - If the patient’s acuity (the severity or intensity of care and medical resources a patient requires) requires another level of care that the organization cannot provide, the organization shall arrange for a safe and appropriate transfer to another organization that can provide the level needed of care. - For a patient requiring continuing care, assistance will be given to the patient and family/caregiver in order to manage continuing care needs and after the organization’s services are discontinued.”

“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 interview and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutic services to a patient’s personal residence) failed to ensure certified home health aide (CHHA) services were provided as written in the plan of care for one of seventeen sampled patients (Patient 17). This failure had a potential to result in Patient 17 will have poor hygiene, decreased mobility support, and increased vulnerability to complications such as skin irritation, pressure injuries, or skin breakdown. Findings: During a review of Patient 17’s clinical record titled “Patient Information”, the “Patient Information” indicated Patient 17 had a start of care (SOC) of 11/7/2025, with diagnoses that included cytokine storm (a severe, dangerous overreaction of the immune system where the body releases too many signaling proteins [cytokines] into the blood too quickly. Instead of just fighting an infection, this flood of proteins causes massive inflammation that can damage tissues and lead to organ failure) and immune disorder (a malfunction where the body’s immune system—which normally fights germs—does not work properly). During a concurrent interview and record review on 5/7/2026 at 12:48 pm., with the Director of Patient Care Services Designee (DPCS Designee), Patient 17’s clinical record titled “Plan of Care” (POC, written document developed for each individual by the agency using a person-centered approach that describes the supports, services, and resources provided or accessed to address the needs of the individual), dated 11/7/2025 was reviewed. The POC indicated Patient 17 would be seen by certified home health aide (CHHA) once a week for four weeks for bathing assistance. The DPCS Designee stated CHHA should assist Patient 17 with bathing to ensure proper hygiene that would prevent skin breakdown. During a concurrent interview and record review on 5/7/2026 at 12:50 pm., with the DPCS Designee, Patient 17’s clinical record titled “View: Aide Visit” (a list of completed and schedule CHHA visit), from 11/7/2025 to 12/23/2025 was reviewed. The “View: Aide Visit” did not contain documentation of any CHHA visits rendered for Patient 17. The DPCS Designee stated that Patient 17 did not receive any CHHA visits while under home health services. During a concurrent interview and record review on 5/7/2026 at 1:20 p.m., with the DPCS Designee, Patient 17’s clinical record titled “Communication Log,” dated 11/12/2025, was reviewed. The Communication Log indicated that on 11/10/2025, Case Manager 2 (CM 2) informed Patient 17’s caregiver (PCG 2) that no CHHA was available to assist Patient 17 with bathing. The DPCS Designee stated that the agency was unable to locate an available CHHA in Patient 17’s area of residence. During a review of HHA’s policies and procedure (P&P), titled “Care Planning Process”, revised on November 2024, the P&P indicated: - The patient-specific clinical plan of care includes types of services, frequency of visits, goals and interventions appropriate to each discipline. - At the time of initial assessment, the clinical and other disciplines involved will develop the individualized patient plan of care based upon the patient’s identified needs and will review it with the patient and family/caregiver. - Problems and/or needs related to the patient’s condition, desires, abilities and family/caregiver support systems will be included in the plan of care.”

“Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This Element is not met as evidenced by: Based on interview, and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to ensure one of 17 patients (Patient 6) was provided with correct colostomy supplies needed for twice weekly ostomy changes prior to discharge on 4/22/2026. This failure to ensure timely and accurate delivery of colostomy supplies resulted in Patient 6 and Patient Care Giver 1 experiencing uncertainty and anxiety about whether they would have the necessary supplies for colostomy care, particularly if their current supply ran out or malfunctioned. During a review of Patient 6’ s clinical record titled “Patient Information”, the “Patient Information” indicated Patient 6 had a Start of Care (SOC) on 4/3/2026, with diagnoses that included Encounter for attention to colostomy (a surgical procedure that brings one end of the large intestine out through the abdominal wall to allow waste to leave the body), Sigmoid adenocarcinoma (a form of cancer arising in the sigmoid colon [the last part of the colon before the rectum]), colitis (inflammation of the inner lining of the colon (large intestine), leading to symptoms like diarrhea, abdominal cramping, and urgent bowel movements.) During a record review of Patient 6’s clinical record titled “Personal Information,” the Personal Information indicated a Start of Care (SOC) dated 4/3/2026, the SOC indicated Patient 6 was admitted to HHA services for colostomy care with colostomy change twice a week or as needed. During an interview on 5/6/2026, at 1:22 p.m., Patient 6’s Caregiver (PCG 1) stated that during the initial home visit on 4/6/2026, PCG 1 requested colostomy supplies to the visiting Registered Nurse 1 (RN1). PCG 1 stated that Patient 6 had only the colostomy supplies provided at discharge from General Acute Care Hospital 1 (GACH) on 4/1/2026, and no additional supplies had been received from the HHA. PCG 1 stated that on 4/13/2026, a call was made to the HHA after hours to inquire about the status of the colostomy supplies. According to PCG 1, HHA staff replied that follow-up would occur during regular business hours, but no follow-up call was received. PCG 1 stated that another call was made to the HHA on 4/17/2026 to request an update on the expected delivery date of the ostomy supplies, and HHA staff reported the supplies were reordered and would be delivered in seven days (4/24/2026). During a concurrent interview and record review on 5/8/2026 at 11:22 a.m., with Licensed Vocational Nurse/Case Manager (CM1), Patient 6’s “Order History”, dated 4/7/2026, 4/17/2026, and 4/24/2026 were reviewed. Patient 6’s “Order History” dated 4/7/2026 indicated ostomy supplies were “Cancelled”. CM1 stated the ordering system automatically cancels the orders if the incorrect supplies were selected. CM 1 stated ostomy supplies were reordered on 4/17/2026 after receiving a call from PCG 1 to inquire regarding the delivery date of Patient 6’s colostomy bag supplies. CM 1 stated that on 4/23/2026, she received an email from Patient 6’s GACH 1 which indicated that Patient 6 had reached out to GACH 1 and stated Patient 6 had received the incorrect colostomy bag supplies (pediatric size). CM 1 stated she placed a new order for the correct supplies on 4/24/2026, and these supplies were delivered to Patient 6’s home on 4/27/2026. During an interview on 5/11/2026, at 9:58 a.m., with PCG 1, PCG1 stated that at the time of discharge (4/22/2026), Patient 6 had one colostomy bag remaining and was worried and concerned about not having the supplies needed for colostomy care if Patient 6’s colostomy bag malfunctioned or dislodged. PCG 1 stated the colostomy bag supplies arrived on 4/27/2026, five days after Patient 6 was discharged from HHA. During an interview on 5/11/2026 at 10:15 p.m., with Registered Nurse 1 (RN 1), RN 1 stated when changing Patient 6’s colostomy bag she would use the colostomy supplies GACH 1 supplied Patient 6 at the time of his discharge (4/1/2026). RN 1 stated that on her last home visit 4/13/2026, Patient 6 had not received colostomy bag supplies, and she would follow up with the case manager. RN 1 stated that if Patient 6 did not change his colostomy bag per physician order it could possibly lead to the colostomy bag bursting, an obstruction, and possibly an infection leading to sepsis. During a review of HHA’s Policy and Procedure (P&P) titled Safe/effective Use of Equipment and Supplies, dated 2009, the P&P indicated, the clinician will, through interview and observation, determine patient and family/ caregiver level of understanding of the use of any equipment and supplies ordered for care, treatment, and service. During a record review titled “Wound Care Supply Order Tracking Procedures” dated 12/1/2025, The “Wound Care Supply Order Tracking Procedures” indicated, the case manager will review the wound care supply request from the SN with SOC/ROC/Recert report or when a patient needs more supplies for ongoing wound care. Case Managers will continue to check on supply status daily until items are delivered. If it has been longer than 1 week, CMs will e mail Rosie Rodriguez to contact DME provider for order status.”

“HHA can no longer meet the patient’s needs CFR(s): 484.50(d)(1) The transfer or discharge is necessary for the patient’s welfare because the HHA and the physician or allowed practitioner, who is responsible for the home health plan of care agree that the HHA can no longer meet the patient’s needs, based on the patient’s acuity. The HHA must arrange a safe and appropriate transfer to other care entities when the needs of the patient exceed the HHA’s capabilities; This Element is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutic services to a patient’s personal residence) failed to ensure a safe and appropriate discharge process for two of 17 sampled patients (Patient 6 and Patient 17) by failing to: a. Ensure Patient 6 was provided with correct colostomy (a surgical procedure that brings one end of the large intestine out through the abdominal wall to allow waste to leave the body) supplies needed for twice weekly colostomy changes prior to discharge on 4/22/2026. b. Ensure a physician’s order for discharge was obtained for Patient 17, who required biweekly blood draw for an immune disorder (occur when the body’s defense network malfunctions) via peripherally inserted central catheter (PICC, a thin, flexible tube that delivers treatments through a vein) and weekly PICC line dressing changes, prior to discharging Patient 17 on 12/23/2025. c. Ensure that Patient 17, who required home health agency services for biweekly blood draws and PICC line dressing changes, was accepted or transferred to a new home health agency who could meet Patient 17’s needs prior to discharging Patient 17 on 12/23/2025. These failures resulted in Patient 6 receiving the incorrect supplies needed for colostomy care upon discharge, increasing the risk of infection and sepsis (a life-threatening reaction to an infection); and a lack in continuity of care for Patient 17 increasing the risk for complications such as PICC line infection, sepsis, and occlusion (partial or complete blockage of a blood vessel or cavity) that could require hospitalization and potentially result in death if left untreated. On 5/12/2026 at 10:38 am the California Department of Public Health called an Immediate Jeopardy (IJ, a situation in which the provider’s non-compliance with one or more requirements of participation has caused, or likely to cause, serious injury, harm impairment, or death to a patient) while onsite, in the presence of the Director of Patient Care Services Designee (DPCS Designee) and Director of Quality Management (DQM) related to the home health agency’s failure to ensure a safe and appropriate discharge process for two of seventeen sampled patients (Patient 6 and Patient 17) by failing to: 1. Ensure Patient 6 was provided with correct colostomy supplies prior to discharge on 4/22/2026; 2. Ensure a physician’s order for discharge was obtained for Patient 17, prior to discharging Patient 17 on 12/23/2025 3. Ensure that Patient 17, who required home health agency services for biweekly blood draws and PICC line dressing changes, was accepted or transferred to a new home health agency who could meet Patient 17’s needs prior to discharging Patient 17 on 12/23/2025. On 5/13/2026 at 12:29 pm, the agency provided an Immediate jeopardy removal plan (IJRP) to the survey team. On 5/13/2026 at 12:30 pm, the survey team reviewed the IJRP and the IJRP was not accepted. On 5/13/2026 at 3:30 pm, the survey team conducted an exit conference while onsite, in the presence of the HHA’s DPCS Designee, DQM and Licensed Vocational Nurse Case Manager (CM 1) with the IJ situation not removed. On 5/18/2026 at 12 pm, the HHA submitted an IJRP. The IJRP was reviewed and accepted on 5/18/2026 at 1:56 pm. On 5/19/2026 at 12:25 pm while onsite the IJ was removed in the presence of the DPCS Designee, the Vice President/Chief Operating Officer and Case Manager after the survey team verified and confirmed the implementation of the IJ removal plan. Findings: a. During a review of Patient 6’ s clinical record titled “Patient Information” (summary of patient’s basic information), the “Patient Information” indicated Patient 6 had a Start of Care (SOC) on 4/3/2026, with diagnoses that included encounter for attention to colostomy (a surgical procedure that brings one end of the large intestine out through the abdominal wall to allow waste to leave the body), Sigmoid adenocarcinoma (a form of cancer arising in the sigmoid colon [the last part of the colon before the rectum]), colitis (inflammation of the inner lining of the colon (large intestine), leading to symptoms like diarrhea, abdominal cramping, and urgent bowel movements.) During a record review of Patient 6’s clinical record titled “Personal Information”, the Personal Information indicated Patient 6 had a SOC date of 4/3/2026, the SOC indicated Patient 6 was admitted to HHA services for colostomy care that required colostomy change twice a week or as needed. During an interview on 5/6/2026, at 1:22 p.m. with Patient 6’s Caregiver (PCG 1), PCG 1 stated that during the initial home visit on 4/6/2026, PCG 1 requested colostomy supplies to the visiting Registered Nurse 1 (RN). PCG 1 stated that Patient 6 had only the colostomy supplies provided at discharge from General Acute Care Hospital 1 (GACH) on 4/1/2026, and no additional supplies had been received from the HHA. PCG 1 stated that on 4/13/2026, a call was made to the HHA after hours to inquire about the status of the colostomy supplies. According to PCG 1, HHA staff responded that follow-up would occur during regular business hours, but no follow-up call was received. PCG 1 stated that another call was made to the HHA on 4/17/2026 to request an update on the expected delivery date of the colostomy supplies, and HHA staff reported that the supplies were reordered and would be delivered in seven days (4/24/2026). During a concurrent interview and record review on 5/8/2026 at 11:22 a.m. with Licensed Vocational Nurse/Case Manager (CM 1), Patient 6’s “Order History”, dated 4/7/2026, 4/17/2026, and 4/24/2026 were reviewed. The “Order History” dated 4/7/2026 indicated colostomy supplies were “Cancelled”. CM 1 stated the ordering system automatically cancels the orders if the incorrect supplies were selected. CM 1 stated colostomy supplies were reordered on 4/17/2026 after receiving a call from PCG 1 to inquire regarding the delivery date of Patient 6’s colostomy supplies. CM 1 stated that on 4/23/2026, she received an email from Patient 6’s GACH 1 which indicated that Patient 6 had reached out to GACH 1 and stated Patient 6 had received the incorrect colostomy supplies. CM 1 stated she then placed a new order for the correct supplies on 4/24/2026, and these supplies were delivered to Patient 6’s home on 4/27/2026. During a concurrent interview and record review on 5/8/2026 at 11:22 am with CM 1, Patient 6’s “Discharge Summary”, dated 4/22/2026, was reviewed. The discharge summary indicated under Patient Progress/Response that Patient 6 was independent with colostomy care, had reached max potential, and had improved knowledge of self-care. CM 1 stated that Patient 6 did not have the appropriate colostomy supplies at the time of discharge on 4/22/2026, which created a safety concern due to the potential for the colostomy bag to leak and for injury to the stoma (a small opening in the abdomen that is used to remove body waste into a collection bag) and surrounding skin. CM 1 stated that the lack of supplies at discharge could lead to frustration and worry for Patient 6 and PCG 1 regarding the possibility of running out of colostomy supplies after HHA services ended. During an interview on 5/11/2026, at 9:58 a.m., with PCG 1, PCG1 stated that at the time of discharge (4/22/2026), Patient 6 had one colostomy bag remaining and was worried and concerned about not having the supplies needed for colostomy care if Patient 6’s colostomy bag malfunctioned or dislodged. PCG 1 stated the colostomy supplies arrived on 4/27/2026, five days after Patient 6 was discharged from HHA. During a review of HHA’s Policy and Procedure (P&P) titled Safe/effective Use of Equipment and Supplies, dated 2009, the P&P indicated, the clinician will, through interview and observation, determine patient and family/ caregiver level of understanding of the use of any equipment and supplies ordered for care, treatment, and service. During a record review titled “Wound Care Supply Order Tracking Procedures” dated 12/1/2025, The “Wound Care Supply Order Tracking Procedures” indicated, the case manager will review the wound care supply request from the Skilled Nurse (SN) with SOC report or when a patient needs more supplies for ongoing wound care. Case Managers will continue to check on supply status daily until items are delivered. If it has been longer than 1 week, CMs will contact durable medical equipment (DME, reusable medical equipment for home use) provider for order status. During a review of HHA’s P&P, titled “Discharge Planning”, revised on November 2024, the P&P indicated: - Patients will not be discharged without appropriate preparation. The patient’s continuing care needs will be assessed on an ongoing basis and at discharge. Information will be provided to assist the patient in planning his/her discharge, including referral and transfer. During a review of HHA’s P&P, titled “Discharge Criteria and Process”, revised on November 2014. The P&P indicated: - For a patient requiring continuing care, assistance will be given to the patient and family/caregiver in order to manage continuing care needs and after the organization’s services are discontinued. b. During a review of Patient 17’s clinical record titled “Patient Information”, the “Patient Information” indicated Patient 17 had a SOC of 11/7/2025, with diagnoses that included cytokine storm (a severe, dangerous overreaction of the immune system where the body releases too many signaling proteins [cytokines] into the blood too quickly. Instead of just fighting an infection, this flood of proteins causes massive inflammation that can damage tissues and lead to organ failure) and immune disorder (a malfunction where the body’s immune system—which normally fights germs—does not work properly). During a review of Patient 17’s clinical record titled “Plan of Care” (POC), dated 11/7/2025, the POC indicated Patient 17 would be discharged when medical condition was stable and when Patient 17 was no longer in need of skilled nursing services. During a review of Patient 17’s clinical record titled “Agency Discharge Report”, dated 12/23/2025, the “Agency Discharge Report” indicated Patient 17 was discharged from HHA services on 12/23/2025 due to out of service area and no available staff. During a review of Patient 17’s electronic mail (email) response, dated 5/9/2026, the email indicated Patient 17 did not receive assistance from HHA to transition care to another HHA. During a concurrent interview and record review on 5/7/2026 at 11:22 am with the DPCS Designee, reviewed Patient 17’s SOC report dated 11/7/2025. The SOC report indicated Patient 17 was admitted to HHA services for blood draw (a medical procedure where a small amount of blood is taken from a vein, for laboratory testing) and PICC line dressing changes for management of Patient 17’s immune disorder. The DPCS Designee stated that PICC line dressings should be changed every one to two weeks to prevent infection which could lead to sepsis and rehospitalization. During a concurrent interview and record review on 5/7/2026 at 11:25 am with the Director of Quality Management (DQM), reviewed Patient 17’s “Communication Note”, dated 12/22/2025 and physician orders from 11/7/2025 to 12/23/2025. The “Communication Note” indicated a late entry for the date 12/19/2025. The “Communication Note” indicated Case Manager 2 (CM 2) notified MD 1 that the HHA would be discharging Patient 17 due to the agency not having available staff for PICC line care and blood draw. The DQM stated Patient 17 requested to have blood drawn before 8:00 am, and the HHA did not have staff available to accommodate the request. The DQM stated if the HHA is unable to provide services to a patient due to lack of available staff to meet the patient’s request, the HHA is to notify the patient’s physician for a planned discharge. The DQM stated that the HHA does not require a discharge order from the physician prior to discharging a patient. The DQM was unable to provide documented evidence of physician order for discharge from the HHA for Patient 17. The DQM was also unable to provide documented evidence of a physician order for transfer to another HHA agency for continuity of care. During an interview on 5/7/2026 at 11:28 am with the DPCS Designee, the DPCS Designee stated that the HHA did not follow up with Patient 17 or Patient 17’s primary caregiver after Patient 17’s discharge on 12/23/2025, to ensure continuity of care, either by verifying that another home health agency had assumed care or that Patient 17 had followed up with Patient 17’s primary physician. During a concurrent interview and record review on 5/7/2026 at 12:36 pm with the DQM, Patient 17’s “Communication Note”, dated 12/18/2025 was reviewed. The “Communication Note” indicated that CM 2 spoke to Patient 17’s primary caregiver regarding HHA inability to accommodate the request for blood draw before 8 am. The “Communication Note” indicated that the HHA will have MD 1 redirect Patient 17’s case to another HHA. The DQM stated the HHA did not follow up on Patient 17 because MD 1 was to direct Patient 17 to another HHA. During an interview on 5/7/2026 at 2:50 pm with MD 1, MD 1 stated that the HHA notified MD 1 regarding Patient 17’s planned discharge but did not provide the date of discharge. MD 1 stated that MD 1 was under the impression that the HHA would assist Patient 17 and Patient 17’s primary caregiver in selecting a new home health agency to ensure continuity of care. MD 1 stated that Patient 17’s PICC line and current health condition required clinical supervision and assessment to prevent infection, sepsis, occlusion (blockage) or deterioration of Patient 17’s condition, which could lead to rehospitalization or death if left untreated. MD 1 stated Patient 17’s visits to MD 1 typically occur every two to three months, which would not be a sufficient interval to ensure that Patient 17’s health condition and PICC line were being appropriately assessed. During an interview on 5/8/2026 at 11 am with the DPCS Designee, the DPCS Designee stated the HHA does not have a process to follow up on discharged patients after they were discharged from the HHA services. The DPCS Designee stated it was the patient’s primary physician’s responsibility to follow up and refer the patients to another HHA. The DPCS Designee was unable to state how the HHA ensured that Patient 17 was discharged safely. During a review of HHA’s P&P, titled “Discharge Planning”, revised in November 2024. The P&P indicated: Patients will not be discharged without appropriate preparation. The patient’s continuing care needs will be assessed on an ongoing basis and at discharge. Information will be provided to assist the patient in planning his/her discharge, including referral and transfer. During a review of HHA’s P&P, titled “Discharge Criteria and Process”, revised in November 2014. The P&P indicated: If the patient’s acuity (the severity or intensity of care and medical resources a patient requires) requires another level of care that the organization cannot provide, the organization shall arrange for a safe and appropriate transfer to another organization that can provide the needed level of care. For a patient requiring continuing care, assistance will be given to the patient and family/caregiver in order to manage continuing care needs and after the organization’s services are discontinued.”

“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 observation, interview, and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient at home) The HHA failed to conduct a complete and accurate review of all medications and failed to update the medication profile with the medications currently being used by three of seventeen sampled patients (Patient 1, Patient 2, and Patient 10). This deficient practice placed these patients at risk for medication errors, omissions, duplications, and adverse drug reactions due to the absence of an accurate and up‑to‑date medication profile. a. During a review of Patient 1’ s clinical record titled “Patient Information”, the “Patient Information” indicated Patient 1 had a Start of Care (SOC) on 12/25/2025, with diagnoses that included type two diabetes mellitus (DM-a disorder characterized by difficulty in blood sugar control and poor wound healing) with foot ulcer (a small open sore or wound generally found in the stomach or on the skin,) osteomyelitis (inflammation of bone or bone marrow, usually due to infection), hyperlipidemia (high levels of cholesterol). During a concurrent interview and record review on 5/7/2026 at 10:36 a.m. with License Vocational Nurse 2 (LVN 2) and Patient 1, at Patient 1’s home, Patient 1’s “Medication profile”, dated 2/25/2026-4/25/2026, was reviewed. Patient 1’s Medication Profile indicated the following: -Furosemide oral 20 milligrams (mg) 1 tab, take 1 tablet by mouth daily as needed for leg swelling, additional shortness of breath, or weight gain of two pounds in a day or five pounds in a week. -Ezetimibe (medication to lower high cholesterol) oral 10 mg 1 tab take one tablet by mouth daily antihyperlipidemic. -Atorvastatin calcium (medication to lower high cholesterol) oral 80mg take one tablet by mouth daily antihyperlipidemic. -Atorvastatin calcium oral 40mg one tab daily antihyperlipidemic. -Lisinopril (medication to lower blood pressure) oral 2.5mg 2 tabs, total of 5mg daily antihypertensive. -Bisoprolol fumarate (medication to lower blood pressure) oral 5mg 0.5 tab take half tablet by mouth. -Jardiance oral 25mg (medication to lower blood sugar in type two diabetes)1 tab take ½ a tablet by mouth once a daily antidiabetic. -Jardiance oral 25mg 1 tab take ½ a tablet by mouth once a daily antidiabetic. -Acetaminophen (medication to lower pain and reduce fever) oral 325mg 1 cap take 2 tablets by mouth every four hour as needed.” Patient 1 stated the following regarding changes in their medication: - Patient 1 stated they were taking half a tablet of “Furosemide oral 20 mg,” as prescribed by her cardiologist (a specialized internal medicine doctor who diagnoses, treats, and prevents diseases of the cardiovascular system—including the heart, arteries, and veins.) months ago. -Patient 1 stated they were no longer taking “Ezetimibe oral 10 mg” due to intolerance which was discussed with her physician. - Patient 1 stated she is taking “atorvastatin calcium oral 80mg” take one tablet by mouth daily. - Patient 1 stated “Lisinopril oral 2.5mg” was discontinued last year (2025) by her nephrologist (a specialized internal medicine doctor who diagnoses, treats, and prevents diseases of the kidney) -Patient 1 stated starting 1/2026 “Bisoprolol fumarate oral 5mg” was changed to one tablet a day by her cardiologist. -Patient 1 stated she doesn’t take “Acetaminophen oral 325mg.” During an interview on 5/7/2026 at 11:17 a.m., LVN 2 explained that she needs to update her Electronic Medical Record Medication Profile to reflect the correct medications and dosages. She emphasized that discontinued, duplicate, or incorrect medication dosages can cause patients to receive too much or too little medication, which may negatively affect their health. LVN 2 stated that when a patient takes the wrong dosage of blood pressure medication, they can become dizzy and fall, possibly resulting in death. She described this situation as “scary.” LVN 2 added that overdosing on diabetic medication decreases sugar levels, which can lead to a diabetic emergency. During an interview on 5/11/2026 at 10:57 a.m., the Director of Quality Management (DQM) emphasized that staff should perform medication reconciliation during every home visit. However, DQM noted that the Home Health Agency (HHA) fails to properly conduct medication reconciliation. DQM explained that the HHA must verify medication reconciliation with Patient 1 and Patient 1’s physician to ensure Patient 1 uses current medications and avoids potential drug interactions. b. During a review of Patient 2’ s clinical record titled “Patient Information”, the “Patient Information” indicated Patient 2 had a Start of Care (SOC) on 4/6/2026, with diagnoses that included pressure ulcer of right buttock, unstageable (localized damage to the skin and/or underlying tissue usually over a bony prominence), Pressure of right hip, unstageable (localized damage to the skin and/or underlying tissue usually over a bony prominence), osteoarthritis (a progressive disorder of the joints, caused by a gradual loss of cartilage). During a concurrent observation, interview and record review on 5/6/2026 at 11:03 a.m. with License Vocational Nurse 1 (LVN 1), at Patient 2’s Senior living facility, Patient 2’s “Medication profile”, dated 4/6/2026-6/4/2026, was reviewed. During medication reconciliation a bottle of Clindamycin HCL (antibiotic used to treat serious bacterial infections, including those of the skin, respiratory tract, and abdomen.) 150 milligrams (mg) capsule, take by mouth four times a day for 10 days, dated 4/30/2026, was observed. LVN 1 stated the clindamycin was not recorded in his updated Electronic Medical Record (EMR) Medication Profile. LVN stated per policy medication reconciliation should be done at every home visit and updated when new or discontinued medications are identified. LVN further stated that taking antibiotics that are not on medication list or prescribed by a Physician can cause upset stomach, diarrhea, and or clostridioides difficile ([C. diff] is a highly contagious bacterium that infects the large intestine, causing severe inflammation and watery diarrhea.) During a concurrent interview and record review on 5/11/2026 at 10:57 a.m. with Director of Quality Management (DQM), Patient 2’s “Medication Profile” dated 4/6/2026-6/4/2026 was reviewed. DQM stated that the order for Clindamycin HCL 150mg capsules, prescribed to be taken by mouth four times a day for 10 days starting 4/30/2026, did not appear on Patient 2’s “Medication Profile.” The DQM explained that staff conduct medication reconciliation during every home visit and emphasized that the visiting nurse must clarify every new order—especially antibiotics—with the Patient’s Physician, as these high-risk medications can trigger allergic reactions. c. During a review of Patient 10’s clinical record titled “Patient Information,” Patient Information indicated Patient 10’s start of care (SOC) date of 4/16/2026 with a primary diagnosis of Type 2 Diabetes mellitus () with foot ulcer (an open sore or wound on the foot, often appearing as a crater). During a concurrent observation and record review on 5/8/2026 at 10:20 a.m. with Registered Nurse (RN) 2 at Patient 10’s residence during a joint home visit, Patient 10’s clinical record titled “Patient Medication Record,” dated 4/27/2026, was reviewed. During a reconciliation review of Patient 10’s medications with RN2, RN 2 stated and confirmed that the following medications were expired or not in the list: Vitamin D3 oral (by mouth) 50 microgram (mcg, unit of weight) 2000 units (unit of measurement), 2 tablets by mouth daily, for vitamins (essential organic compounds that the body needs in small amounts to function, grow, and stay healthy), with expiration date of April 2023. Ginkgo (an over-the-counter herbal remedy made from the fan-shaped leaves of the ancient Ginkgo biloba tree and is commonly taken as a daily capsule, tablet, or extract to promote better blood flow and support brain functions like memory and concentration) oral 60 milligram (mg, unit of weight), 1 tablet by mouth daily, for alternative medicines (used in placed of conventional treatment), with expiration date of August 2024. Biotin (is an essential nutrient that is naturally present in some foods and available as a dietary supplement) oral, 1000 mcg, 1 tablet by mouth daily for vitamins, with expiration date of May 2025. Sacubitril-Valsartan (is a prescription heart medication, a combination of two medications that work together to relax blood vessels, reduce strain on the heart, and lower the risk of heart failure - a condition in which the heart muscle cannot pump enough blood to meet the body’s needs for blood and oxygen) 24-26 mg, Generic for: Entresto, take 1 tablet by mouth, twice a day, was not included in Patient 10’s current medication record. During an interview on 5/8/2026 at 10:48 a.m. with Patient 10, Patient 10 stated she had recently begun taking the medication Entresto and could not recall whether she informed RN2 about it during his last visit. During an interview on 5/8/2026 at 11:15 a.m., RN2 stated he completed Patient 10’s medication reconciliation at the start of care and asked the patient during subsequent visits if any medications had been added or discontinued by her primary care physician. RN2 stated that Patient 10 did not inform him about her new medication, Entresto, during his last visit. During an interview on 5/11/2026 at 12:15 p.m., the Director of Quality Management (DQM) stated that it is standard practice for HHA nurses to ensure that patients’ medications are current, unexpired, and accurately reconciled. The DQM stated that nurses are expected to conduct medication reconciliation at each visit and, when patients report new medications, to coordinate with the HHA or the physician so the current medication list can be updated, thereby preventing the continuation of discontinued medications and avoiding confusion among the healthcare team and the patient. During a review of HHA’s Policy & Procedure, titled “Medication Profile,” revised in November 2024. The P&P indicated the following: Patients receiving medications will have a current, accurate medication profile in the clinical record.Medication profiles will be updated for each change to reflect current medications and new and/or discontinued medications.During subsequent home visits, the medication profile will be used as a care planning and teaching guide to ensure that the patient and family/caregiver, as well as other clinicians, understand the medication regimen.”

“All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This Element is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to ensure a physician’s order was obtained and recorded in the plan of care for one of seventeen sampled patients (Patient 10). For Patient 10, the HHA did not have a physician’s order regarding the use of the Fiasp FlexTouch insulin pen (is a pre-filled, disposable insulin pen used to manage blood sugar levels in adults and children with diabetes (a chronic condition where the body does not produce enough insulin (a hormone produced by the pancreas that helps regulate blood sugar levels) or cannot properly use the insulin it produces, leading to high blood sugar levels), and contains a rapid-acting insulin that starts working very quickly, usually within 10–20 minutes to control blood sugar spikes at mealtimes) subcutaneous (situated or occurring directly under the skin, specifically within the fatty tissue layer located between the skin and the muscle), including the indication, dose, route, frequency, time of administration, and parameters for when the insulin should or should not be administered. This information was not incorporated into the patient’s plan of care as required. This failure placed Patient 10 at increased risk for potential complications such as hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar). During a review of Patient 10’s clinical record titled “Patient Information,” Patient Information indicated Patient 10’s start of care (SOC) date of 4/16/2026 with a primary diagnosis of Type 2 Diabetes mellitus with foot ulcer (an open sore or wound on the foot, often appearing as a crater). During a concurrent observation and record review on 5/8/2026 at 10:20 a.m., with Registered Nurse (RN) 2 at Patient 10’s residence during a joint home visit, the following medications were listed on Patient 10’s clinical record titled “Patient Medication Record,” dated 4/27/2026, and was present in the home: Fiasp FlexTouch subcutaneous 100 unit/ml 20 units inject subcutaneously three times daily (Antidiabetics). During an interview on 5/8/2026 at 10:45 a.m., with Patient 10 stated she had been using the insulin pen (Fiasp) for several years prior to admission to the HHA. Patient 10 reported that she checks her blood glucose level only once in the morning and not prior to each insulin administration. She stated she self‑administers Fiasp 20 units three times daily. During an interview on 5/8/2026 at 11:12 a.m., with RN 2, RN 2 stated he conducted Patient 10’s medication reconciliation at start of care. RN 2 stated that insulin medications are high‑risk. RN 2 stated that Fiasp is a fast‑acting insulin that can rapidly lower blood glucose within 15 to 20 minutes after administration. RN 2 stated that standard practice requires the patient to check blood glucose level prior to insulin administration to ensure it is not low before administering it. RN 2 stated that if Patient 10 is not checking her blood glucose before each administration, Patient 10 is at risk for a hypoglycemic episode that could result in hospitalization or death if left untreated. RN 2 stated that parameters for insulin administration should have been established and communicated to Patient 10’s primary physician to ensure the patient was checking her blood glucose level prior to each insulin self‑administration. During an interview and concurrent record review on 5/11/2026 at 10:56 a.m. with the Director of Quality Management (DQM), Patient 10’s clinical record titled “Patient Medication Record,” was reviewed. The DQM confirmed and stated that medication below is included in Patient 10’s Patient Medication Record: Fiasp FlexTouch subcutaneous 100 unit/ml 20 units inject subcutaneously three times daily (Antidiabetics). During an interview and concurrent record review on 5/11/2026 at 11:14 a.m., with the DQM, Patient 10’s admission record titled “Progress Notes,” dated 3/24/2026 was reviewed. The DQM confirmed and stated that the following medication was not listed in Patient 10’s Progress Note dated 3/24/2026: Fiasp FlexTouch subcutaneous 100 unit/ml 20 units inject subcutaneously three times daily (Antidiabetics). During an interview and concurrent record review on 5/11/2026 at 11:36 a.m., with the DQM, Patient 10’s clinical record titled “Home Health Certification and Plan of Care (POC, a written documented created by healthcare professionals and the patient to manage health needs),” with certification period from 4/16/2026 to 6/14/2026, was reviewed. The DQM confirmed and stated that Patient 10’s Home Health Certification and POC dated 4/16/2026 to 6/14/2026, did not include a medication order for: Fiasp FlexTouch subcutaneous 100 unit/ml 20 units inject subcutaneously three times daily (Antidiabetics). The DQM stated that RN 2 may have missed to include the Fiasp FlexTouch insulin order in the Home Health Certification and POC submitted to the physician. The DQM stated that standard practice requires the admitting nurse to reconcile all medications on hand with the admission records and, when discrepancies are identified, to contact the healthcare team, including the patient’s physician, to determine whether a medication should be continued and obtained a physician’s order. During an interview on 5/11/2026 at 12 p.m., with the DQM, the DQM stated there was no documentation verifying an order for the Fiasp insulin pen from Patient 10’s primary physician. The DQM stated that standard practice requires the HHA nurse to contact the primary physician to clarify the insulin order, including the indication, dose, route, frequency, time of administration, and instructions for when the insulin should or should not be administered. The DQM stated that the clinical record did not reflect when the Fiasp FlexTouch insulin order was communicated to, or obtained from, the physician. During an interview on 5/11/2026 at 12:10 p.m., with the DQM stated that visiting nurses should be every visit – medication reconciliation, look at the med list and go over with the patient if the patient is taking or not, focusing/emphasize on the high risks medications – going over with the current dose or changes, completion on antibiotics including expiration of the medications, if expired the efficacy of the medications is decreased. If medication reconciliation not done every visit – overdosing/underdosing, taking medication as ordered by the physician. During an interview and concurrent record review on 5/11/2026 at 11:43 a.m., with RN 2, Patient 10’s clinical records titled, “RN Skilled Nursing Visit” notes dated 4/20/2026, 4/22/2026, 4/24/2026, 4/27/2026, 4/29/2026, 5/1/2026, and 5/4/2026 were reviewed. RN 2 stated and confirmed that these visit notes did not include any documentation indicating communication with Patient 10’s primary care physician to obtain or clarify the order for the Fiasp insulin pen. During an interview and concurrent record review on 5/11/2026 at 10:56 a.m., the Director of Quality Management (DQM) reviewed Patient 10’s “Patient Medication Record” and confirmed that the following medication was listed: Fiasp FlexTouch subcutaneous 100 unit/mL, 20 units injected subcutaneously three times daily (Antidiabetic). During an interview and concurrent record review on 5/11/2026 at 11:14 a.m., the DQM reviewed Patient 10’s admission “Progress Notes” dated 3/24/2026 and confirmed that the Fiasp FlexTouch insulin pen was not listed in the record. During an interview and concurrent record review on 5/11/2026 at 11:36 a.m., the DQM reviewed Patient 10’s “Home Health Certification and Plan of Care” for the certification period 4/16/2026–6/14/2026 and confirmed the POC did not include an order for: Fiasp FlexTouch subcutaneous 100 unit/mL, 20 units injected subcutaneously three times daily (Antidiabetic). During an interview and concurrent record review on 5/11/2026 at 11:48 a.m., the DQM reviewed Patient 10’s electronic medical record (EMR, is a digital version of a patient’s paper chart kept by one healthcare provider or organization. It includes the patient’s medical history, treatments, medications, and notes from visits—all stored on a computer instead of on paper) and confirmed there was no documented physician’s order for the Fiasp FlexTouch insulin pen. The DQM stated that RN 2 may have failed to include the insulin order in the POC submitted to the physician and stated that standard practice requires the admitting nurse to reconcile all medications and notify the healthcare team, including the physician, to clarify and obtain needed orders when discrepancies arise. During an interview on 5/11/2026 at 12 p.m., the DQM stated there was no documentation verifying an order for Fiasp from Patient 10’s primary physician. The DQM stated standard practice requires the nurse to clarify the insulin order with the physician, including indication, dose, route, frequency, time of administration, and instructions regarding when the medication should or should not be administered. The DQM confirmed the clinical record did not reflect any communication with the physician regarding the Fiasp FlexTouch insulin pen. During an interview on 5/11/2026 at 12:10 p.m., the DQM stated that visiting nurses were required to perform medication reconciliation at every visit. The DQM explained this includes reviewing the patient’s medication list with the patient, confirming which medications the patient is taking, and placing emphasis on high‑risk medications. The DQM stated the nurse should verify current dosages, any recent changes, and the completion status of antibiotics, as well as check for expired medications, since expired medications may have reduced effectiveness. The DQM stated that if medication reconciliation is not completed at every visit, the patient is at risk of overdosing or underdosing and may not take medications as prescribed by the physician. During an interview and concurrent record review on 5/12/2026 at 11:43 a.m., RN 2 reviewed “RN Skilled Nursing Visit” notes dated 4/20/2026, 4/22/2026, 4/24/2026, 4/27/2026, 4/29/2026, 5/1/2026, and 5/4/2026, and confirmed these notes did not include any documentation of communication with Patient 10’s physician regarding the Fiasp insulin pen. During an interview and concurrent review on 5/12/2026 at 11:55 a.m., RN 2 reviewed “Physician Order” forms dated 4/20/2026 and 4/27/2026 and confirmed that no order for the Fiasp insulin pen was documented. RN 2 stated that Patient 10 did not disclose use of the Fiasp insulin pen during the 4/16/2026 start‑of‑care medication reconciliation and that he became aware of the medication on 4/20/2026. RN 2 stated he added the medication to the medication record per label instructions but acknowledged he should have documented the reconciliation in his visit notes and contacted the physician to clarify and obtain a valid order. RN 2 further stated it was important to confirm with the physician whether the medication was to be continued and whether the dosage was correct. During a review of HHA’s P&P, titled “Physician’s Participation in Plan of Care”, revised in November 2024. The P&P indicated the physician will direct the care of every home health patient admitted for service. During a review of HHA’s P&P, titled “Care Coordination”, revised on November 2024. The P&P indicated: The care coordination will include coordinate communication with all physicians involved in the plan of care.”

“Communication with all physicians CFR(s): 484.60(d)(1) Standard: Coordination of Care. The HHA must: (1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This Element is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to ensure effective communication with the primary physician regarding the plan of care for two of seventeen sampled patients (Patient 10 and Patient 17) by failing to: a. Communicate with Patient 10’s primary care physician (MD 2) regarding the use of the Fiasp FlexTouch insulin pen (is a pre-filled, disposable insulin pen used to manage blood sugar levels in adults and children with diabetes (a chronic condition where the body does not produce enough insulin (a hormone produced by the pancreas that helps regulate blood sugar levels) or cannot properly use the insulin it produces, leading to high blood sugar levels), and contains a rapid-acting insulin that starts working very quickly, usually within 10–20 minutes to control blood sugar spikes at mealtimes) subcutaneous (situated or occurring directly under the skin, specifically within the fatty tissue layer located between the skin and the muscle), including the indication, dose, route, frequency, time of administration, and instructions for when the insulin should or should not be administered. b. Notify Patient 17’s primary physician (MD 1) that the patient was receiving care and services from the HHA. Notify MD 1 Patient 17 was discharged without a transfer being arranged to another home health agency. This failure had the potential to result in placing Patient 10 at increased risk for hypoglycemia (low blood sugar level) and hyperglycemia (high blood sugar level). Patient 17 was placed at increased risk for delays in essential medical oversight, missed follow up care, and gaps in continuity of services, which could contribute to preventable health deterioration or adverse health outcomes (any negative or undesirable effects on a person’s physical, mental, or social well-being that can range from temporary harm to permanent disability or death). a. During a review of Patient 10’s clinical record titled “Patient Information,” Patient Information indicated Patient 10’s start of care (SOC) date of 4/16/2026 with a primary diagnosis of Type 2 Diabetes mellitus with foot ulcer (an open sore or wound on the foot, often appearing as a crater). During a concurrent observation and record review on 5/8/2026 at 10:20 a.m., with Registered Nurse (RN) 2 at Patient 10’s residence during a joint home visit, the following medications were listed on Patient 10’s clinical record titled “Patient Medication Record,” dated 4/27/2026, and were present in the home: Lantus Solostar (a prefilled, disposable pen used to inject long-acting insulin to manage blood sugar levels in adults and children with diabetes) subcutaneous 100 unit/ml 25 units inject subcutaneously twice daily (Antidiabetics). Fiasp FlexTouch subcutaneous 100 unit/ml 20 units inject subcutaneously three times daily (Antidiabetics). During an interview on 5/8/2026 at 10:45 a.m., with Patient 10, Patient 10 stated she had been using the two insulin pens (Fiasp and Lantus) for several years prior to admission to the HHA. Patient 10 reported that she checks her blood glucose level only once in the morning and not prior to each insulin administration. She stated she self‑administers Fiasp 20 units three times daily and Lantus 20 units twice daily. Patient 10 stated that the HHA nurses did not instruct her to check her blood glucose level before each insulin administration. During an interview on 5/8/2026 at 11:12 a.m., with RN 2, stated he conducted Patient 10’s medication reconciliation at start of care. RN 2 stated that insulin medications are high‑risk. RN 2 stated that Fiasp is a fast‑acting insulin that can rapidly lower blood glucose within 15 to 20 minutes after administration, while Lantus is a long‑acting insulin that lowers blood glucose gradually. RN 2 stated that standard practice requires the patient to check blood glucose level prior to insulin administration to ensure it is not low before administering it. RN 2 stated that if Patient 10 is not checking her blood glucose before each administration, Patient 10 is at risk for a hypoglycemic episode that could result in hospitalization or death if left untreated. RN 2 stated that parameters for insulin administration should have been established and communicated to Patient 10’s primary physician to ensure the patient was checking her blood glucose level prior to each insulin self‑administration. During an interview on 5/8/2026 at 11:48 a.m., with Patient 10’s primary physician (MD 2), MD2 stated she has been Patient 10’s physician for several years and had prescribed Fiasp and Lantus for diabetes management. MD 2 stated that Patient 10 is required to check her blood glucose level prior to each insulin self‑administration and to hold the insulin if her blood glucose is below 100 mg/dL. MD 2 stated that Patient 10 was supposed to be using a sensor which is continuous glucose monitor (is a wearable medical device that tracks the blood sugar levels 24 hours a day without needing constant finger pricks)) to track her blood glucose levels. MD 2 further stated that self‑administering insulin without checking blood glucose could result in serious complications, including hypoglycemic episodes and possible hospitalization. MD 2 stated that no HHA nurse had contacted her or her office for clarification of Patient 10’s insulin orders. During an interview and concurrent record review on 5/11/2026 at 10:56 a.m., with the Director of Quality Management (DQM), Patient 10’s clinical record titled “Patient Medication Record,” was reviewed. The DQM confirmed and stated that medications below are included in Patient 10’s Patient Medication Record: Lantus Solostar subcutaneous 100 unit/ml 25 units inject subcutaneously twice daily (Antidiabetics). Fiasp FlexTouch subcutaneous 100 unit/ml 20 units inject subcutaneously three times daily (Antidiabetics). During an interview and concurrent record review on 5/11/2026 at 11:14 a.m., with the DQM, Patient 10’s admission record titled “Progress Notes,” dated 3/24/2026 was reviewed. The DQM confirmed and stated that the following medications were not listed in Patient 10’s Progress Note dated 3/24/2026: Lantus Solostar subcutaneous 100 unit/ml 25 units inject subcutaneously twice daily (Antidiabetics). Fiasp FlexTouch subcutaneous 100 unit/ml 20 units inject subcutaneously three times daily (Antidiabetics). During an interview and concurrent record review on 5/11/2026 at 11:36 a.m. with the DQM, Patient 10’s clinical record titled “Home Health Certification and Plan of Care (POC, a written documented created by healthcare professionals and the patient to manage health needs),” with certification period from 4/16/2026 to 6/14/2026, was reviewed. The DQM confirmed and stated that Patient 10’s Home Health Certification and POC dated 4/16/2026 to 6/14/2026, indicated a medication order of: Lantus Solostar subcutaneous 100 unit/ml 20 units inject subcutaneously twice daily (Antidiabetics). The DQM confirmed and stated that Patient 10’s Home Health Certification and POC dated 4/16/2026 to 6/14/2026, did not include a medication order of: Fiasp FlexTouch subcutaneous 100 unit/ml 20 units inject subcutaneously three times daily (Antidiabetics). During an interview and concurrent record review on 5/11/2026 at 11:48 a.m., with the DQM, Patient 10’s electronic medical records (EMR, is a digital, computer-based version of a patient’s paper chart, containing their medical and treatment history within a single healthcare organization), were reviewed. The DQM confirmed and stated that there was no documented physician’s order for the medication: Fiasp FlexTouch subcutaneous 100 unit/ml 20 units inject subcutaneously three times daily (Antidiabetics). The DQM stated that RN 2 may have missed to include the Fiasp FlexTouch insulin order in the Home Health Certification and POC submitted to the physician. The DQM stated that standard practice requires the admitting nurse to reconcile all medications on hand with the admission records and, when discrepancies are identified, to contact the healthcare team, including the patient’s physician, to determine whether a medication should be continued and obtained a physician’s order. During an interview on 5/11/2026 at 12 p.m., with the DQM, the DQM stated there was no documentation verifying an order for the Fiasp insulin pen from Patient 10’s primary physician. The DQM stated that standard practice requires the HHA nurse to contact the primary physician to clarify the insulin order, including the indication, dose, route, frequency, time of administration, and instructions for when the insulin should or should not be administered. The DQM stated that the clinical record did not reflect when the Fiasp FlexTouch insulin order was communicated to, or obtained from, the physician. During an interview on 5/11/2026 at 12:10 p.m., with the DQM stated that standard practice requires the HHA nurse to ensure that patients on insulin should be checking the blood glucose level prior to each insulin administration. The DQM stated that if a patient is self-administering insulin medication without checking the blood glucose level first, patient can be at risk of administering the insulin when blood glucose is low that can result to hypoglycemic episodes, hospitalization or could have a detrimental effect that include death. The DQM stated that patients on insulin should be maintaining blood glucose reading logs to monitor effectively if there were any significant changes with the blood glucose readings. The DQM stated that clarifying blood glucose parameters with the physician and incorporating them into the insulin orders would help ensure the patient does not receive an overdose of insulin. During an interview and concurrent record review on 5/12/2026 at 11:43 a.m., with RN 2, Patient 10’s clinical records titled, “RN Skilled Nursing Visit” notes dated 4/20/2026, 4/22/2026, 4/24/2026, 4/27/2026, 4/29/2026, 5/1/2026, and 5/4/2026 were reviewed. RN 2 stated and confirmed that these visit notes did not include any documentation indicating communication with Patient 10’s primary care physician to obtain or clarify the order for the Fiasp insulin pen. During an interview and concurrent record review on 5/12/2026 at 11:55 a.m., with RN 2, Patient 10’s “Physician Order” forms dated 4/20/2026 and 4/27/2026 were reviewed. RN 2 stated and confirmed that these orders did not include documentation of an order for the Fiasp insulin pen. RN 2 stated that during the start‑of‑care visit on 4/16/2026, Patient 10 did not disclose the use of the Fiasp insulin pen during medication reconciliation and that he became aware of the medication during the 4/20/2026 visit. RN 2 stated he added the Fiasp insulin pen, including the indication, dose, route, frequency, and time of administration per label instructions, to the medication record. RN 2 stated he should have documented the medication reconciliation in his visit notes and communicated with the physician to clarify and obtain a valid order. RN 2 further stated it was important to confirm with the physician whether the Fiasp insulin pen was intended to be continued and whether the dosage was correct. b. During a review of Patient 17’s clinical record titled “Patient Information”, the “Patient Information” indicated Patient 17 had a Start of Care (SOC) on 11/7/2025, with diagnoses that included cytokine storm (a severe, dangerous overreaction of the immune system where the body releases too many signaling proteins [cytokines] into the blood too quickly. Instead of just fighting an infection, this flood of proteins causes massive inflammation that can damage tissues and lead to organ failure) and immune disorder (a malfunction where the body’s immune system—which normally fights germs—does not work properly). During a review of Patient 17’s clinical record titled “CMS 485” (Plan of Care, POC), dated 11/7/2025. The POC indicated Patient 17 would be discharged when medical condition is stable and Patient 17 is no longer in need of skilled nursing services. During a review of Patient 17’s clinical record titled “Agency Discharge Report”, dated 12/23/2025, the “Agency Discharge Report” indicated Patient 17 was discharged from HHA services on 12/23/2025 due to out of service area and no available staff. During a concurrent interview and record review on 5/7/2026 at 11:22 am., with the DPCS Designee, reviewed Patient 17’s SOC report dated 11/7/2025. The SOC report indicated Patient 17 was admitted to HHA services for blood draw (a medical procedure where a small amount of blood is taken from a vein, for laboratory testing) and PICC line dressing changes for management of Patient 17’s immune disorder. The DPCS Designee stated that PICC line dressings should be changed every one to two weeks to prevent infection which could lead to sepsis and rehospitalization. During a concurrent interview and record review on 5/7/2026 at 12:36 pm., with the Director of Quality Management (DQM), Patient 17’s clinical record titled “Patient Communication”, dated 12/18/2025 was reviewed. The “Patient Communication” indicated Case Manager 2 (CM 2) notified Patient 17’s primary caregiver that the HHA did not have staff to accommodate Patient 17’s request to draw blood before 8 am. The “Patient Communication” indicated CM 2 would notify MD 1 to redirect Patient 17’s need for PICC line change and blood draw to another HHA. During a concurrent interview and record review on 5/7/2026 at 11:25 am, with the Director of Quality Management (DQM), Patient 17’s “Communication Note”, dated 12/22/2025 was reviewed. The “Communication Note” indicated this note was a late entry for the date 12/19/2025. The “Communication Note” indicated Case Manager 2 (CM 2) notified MD 1 that the HHA would be discharging Patient 17 due to the agency not having available staff for PICC line care and lab draw. The DQM was unable to provide documented evidence that MD 1 agreed Patient 17 would be safely discharged from HHA and that MD 1 will coordinate Patient 17’s care to another HHA. The DQM was unable to provide documented evidence that the established discharge date for Patient 17 was communicated to MD 1. During an interview on 5/7/2026 at 2:50 pm., with MD 1, stated that the HHA notified MD 1 regarding Patient 17’s planned discharge but did not provide the date of the planned discharge. MD 1 stated that MD 1 was under the impression that the HHA would assist Patient 17 and the patient’s primary caregiver in selecting a new home health agency to ensure continuity of care. MD 1 stated that Patient 17’s PICC line and current health condition required clinical supervision and assessment to prevent infection, sepsis, occlusion or deterioration of Patient 17’s condition, which could lead to rehospitalization. MD 1 stated Patient 17’s visits typically occurred every two to three months, which would not be a sufficient interval to ensure that Patient 17’s health condition and PICC line are being appropriately assessed. During a concurrent interview and record review on 5/8/2026 at 10:57 am., with Case Manager 1 (CM 1), Patient 17’s “Physician Order”, dated 12/5/2025 was reviewed. The Physician’s Order indicated MD 1 had never spoken to anyone from HHA until 12/5/2025 with CM 1. CM 1 recalled speaking to MD 1 on 12/9/2025, MD 1 was not aware that Patient 17 was being seen by HHA. CM 1 stated discharge planning for Patient 17 was not discussed with MD 1. During an interview on 5/8/2026 at 12:59 p.m., with CM 1 stated that HHA provides services and treatment to patients according to the plan of care approved by the physician. CM 1 stated that if the HHA is unable to provide any service under the plan of care, the HHA should notify the physician to ensure clinical oversight on Patient 17’s care. During a review of HHA’s P&P, titled “Discharge Planning”, revised on November 2024. The P&P indicated clinicians will assist patients regarding their discharge by coordinating discharge with the patient’s physician or allowed practitioner. During a review of HHA’s P&P, titled “Physician’s Participation in Plan of Care”, revised on November 2024. The P&P indicated the physician will direct the care of every home health patient admitted for service. During a review of HHA’s P&P, titled “Care Coordination”, revised on November 2024. The P&P indicated: The care coordination will include coordinate communication with all physicians involved in the plan of care.”

“Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient’s needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This Element is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA- an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to coordinate care delivery and involve the patient or primary caregiver (PCG) in the care planning process for two of seventeen sampled patients (Patient 10 and Patient 17). For Patient 10, the HHA did not engage the patient or PCG in discussions regarding the Fiasp FlexTouch insulin pen (is a pre-filled, disposable insulin pen used to manage blood sugar levels in adults and children with diabetes (a chronic condition where the body does not produce enough insulin (a hormone produced by the pancreas that helps regulate blood sugar levels) or cannot properly use the insulin it produces, leading to high blood sugar levels), and contains a rapid-acting insulin that starts working very quickly, usually within 10–20 minutes to control blood sugar spikes at mealtimes) subcutaneous (situated or occurring directly under the skin, specifically within the fatty tissue layer located between the skin and the muscle) regimen, including the instructions for use, administration parameters, and the physician’s required orders, resulting in a lack of coordinated and informed participation in the patient’s care. For Patient 10, the HHA did not engage the patient or PCG in discussions regarding the Sacubitril-Valsartan (is a prescription heart medication, a combination of two medications that work together to relax blood vessels, reduce strain on the heart, and lower the risk of heart failure - a condition in which the heart muscle cannot pump enough blood to meet the body’s needs for blood and oxygen) regimen, including the instructions for use, resulting in a lack of coordinated and informed participation in the patient’s care. For Patient 17, the HHA did not notify or involve the patient or PCG on the changes made to the discharge plan and the date the Patient 17 would be discharged from home health services. These deficient practices limited the patients and caregivers’ abilities to participate in care decisions and compromised the continuity and coordination of services necessary to meet their individualized needs. Findings: During a review of Patient 17’s clinical record titled “Patient Information”, the “Patient Information” indicated Patient 17 had a start of care (SOC) of 11/7/2025, with diagnoses that included cytokine storm (a severe, dangerous overreaction of the immune system where the body releases too many signaling proteins [cytokines] into the blood too quickly. Instead of just fighting an infection, this flood of proteins causes massive inflammation that can damage tissues and lead to organ failure) and immune disorder (a malfunction where the body’s immune system—which normally fights germs—does not work properly). During a review of Patient 17’s clinical record titled “Plan of Care (POC, written document developed for each individual by the agency using a person-centered approach that describes the supports, services, and resources provided or accessed to address the needs of the individual), dated 11/7/2026. The POC indicated Patient 17 would be discharged when medical condition is stable and Patient 17 is no longer in need of skilled nursing services. During a concurrent interview and record review on 5/7/2026 at 11:22 am with the DPCS Designee, reviewed Patient 17’s SOC report dated 11/7/2025. The SOC report indicated Patient 17 was admitted to HHA services for blood draw (a medical procedure where a small amount of blood is taken from a vein, for laboratory testing) and PICC line dressing changes for management of Patient 17’s immune disorder. The DPCS Designee stated that PICC line dressings should be changed every one to two weeks to prevent infection which could lead to sepsis and rehospitalization. During a concurrent interview and record review on 5/7/2026 at 12:36 pm with the DQM, Patient 17’s “Communication Note”, dated 12/18/2026 was reviewed. The “Communication Note” indicated that Case Manager 2 (CM 2) informed Patient 17’s primary caregiver (PCG 2) that the agency was unable to accommodate Patient 17’s request for a blood draw before 8:00 am. The DQM stated that the Communication Note did not indicate that CM 2 notified PCG 2 of the date of Patient 17’s planned discharge. During a concurrent interview and record review on 5/12/2026 at 12:46 pm with the DQM, Patient 17’s “Registered Nurse (RN) Visit”, dated 11/11/2025, 11/28/2025, 11/25/2025, 11/28/2025 and 12/11/2025, was reviewed, the “RN Visit” indicated Patient 17 will be discharge at the end of POC. The “RN Visit” did not contain information regarding the date of Patient 17’s planned discharge. The DQM stated that if the discharge date was established for Patient 17, the discharge date should be indicated in the “RN Visit” note and the discussion regarding the planned discharged. During a concurrent interview and record review on 5/12/2026 at 12:48 p.m. with the DQM, Patient 17’s “Registered Nurse (RN) Visit” note dated 12/22/2026 was reviewed, the “RN Visit” indicated Patient 17 will be discharge at the end of POC. The “RN Visit” did not contain information regarding the date of Patient 17’s planned discharge. The DQM stated that Patient 17 and PCG 2 should be notified no later than the final visit prior to the discharge date. The DQM stated that advance notification is necessary to ensure Patient 17 and PCG 2 are prepared and educated on caring for Patient 17’s PICC line once home health services have ended. The DQM stated that education and discussions regarding Patient 17’s discharge should be documented in the patient’s clinical record. The DQM was unable to provide documentation showing that Patient 17 and PCG 2 were notified prior to the planned discharge on 12/23/2026. During a review of HHA’s policies and procedures (P&P), titled “Care Coordination”, revised on November 2024, the P&P indicated: - Coordination of care delivery to meet the patient’s needs, and involve the patient, representative, and caregivers in coordination of care activities. - Written evidence of coordination may be found in the plan of care, or clinical notes in the patient’s clinical record. During a review of HHA’s P&P, titled “Discharge Planning”, revised on November 2024, the P&P indicated: -Patients will note be discharged without appropriate preparation. The patient’s continuing care needs will be assessed on an ongoing basis and at discharge. Information will be provided to assist the patient in planning his/her discharge. a. During a review of Patient 10’s clinical record titled “Patient Information,” Patient Information indicated Patient 10’s start of care (SOC) date of 4/16/2026 with a primary diagnosis of Type 2 Diabetes mellitus with foot ulcer (an open sore or wound on the foot, often appearing as a crater). During a concurrent observation and record review on 5/8/2026 at 10:20 a.m. with Registered Nurse (RN) 2 at Patient 10’s residence during a joint home visit, the following medications were listed on Patient 10’s clinical record titled “Patient Medication Record,” dated 4/27/2026, and were present in the home: Fiasp FlexTouch subcutaneous 100 unit/ml 20 units inject subcutaneously three times daily (Antidiabetics). Sacubitril-Valsartan 24-26 mg, Generic for: Entresto, take 1 tablet by mouth, twice a day, this medication was not included in Patient 10’s current medication record. During an interview on 5/8/2026 at 10:45 a.m., with Patient 10, Patient 10 stated she had been using the insulin pen (Fiasp) for several years prior to admission to the HHA. Patient 10 reported that she checks her blood glucose level only once in the morning and not prior to each insulin administration. She stated she self‑administers Fiasp 20 units three times daily. Patient 10 stated that the HHA nurses did not instruct her to check her blood glucose level before each insulin administration. Patient 10 stated that she was unaware of Friasp insulin was not listed in her plan of care copy and the visiting nurse did not discuss with her about it. During an interview on 5/8/2026 at 10:45 a.m. with Patient 10, Patient stated that she had been using the Fiasp insulin pen for several years prior to admission to the HHA. Patient 10 stated she checks her blood glucose (sugar) level only once in the morning and does not check prior to each insulin administration. Patient 10 stated that she self‑administers Fiasp 20 units three times daily. Patient 10 stated that HHA nursing staff did not instruct her to check her blood glucose level before each insulin administration. She also stated she was unaware that Fiasp insulin was not included in the copy of her plan of care and that the visiting nurse did not discuss this. During an interview on 5/8/2026 at 10:48 a.m. with Patient 10, Patient 10 stated that she had recently begun taking the medication Entresto and could not recall whether she informed RN2 about this during his previous visit several days ago. Patient 10 stated that she did not recall RN2 asking her about any new medications during his previous visit several days ago. During an interview on 5/8/2026 at 11:12 a.m., with RN 2, RN 2 stated he conducted Patient 10’s medication reconciliation at start of care. RN 2 stated that insulin medications are high‑risk. RN 2 stated that Fiasp is a fast‑acting insulin that can rapidly lower blood glucose within 15 to 20 minutes after administration. RN 2 stated that standard practice requires the patient to check blood glucose level prior to insulin administration to ensure it is not low before administering it. RN 2 stated that if Patient 10 is not checking her blood glucose before each administration, Patient 10 is at risk for a hypoglycemic episode that could result in hospitalization or death if left untreated. RN 2 stated that parameters for insulin administration should have been established and communicated to Patient 10’s primary physician to ensure the patient was checking her blood glucose level prior to each insulin self‑administration. During an interview on 5/8/2026 at 11:15 a.m., RN2 stated he completed Patient 10’s medication reconciliation at the start of care and asked the patient during subsequent visits if any medications had been added or discontinued by her primary care physician. RN2 stated that Patient 10 did not inform him about her new medication, Entresto, during his last visit. During an interview on 5/8/2026 at 11:48 a.m., with Patient 10’s primary physician (MD 2), MD2 stated she has been Patient 10’s physician for several years and had prescribed Fiasp and Lantus for diabetes management. MD 2 stated that Patient 10 is required to check her blood glucose level prior to each insulin self‑administration and to hold the insulin if her blood glucose is below 100 mg/dL. MD 2 stated that Patient 10 was supposed to be using a sensor which is continuous glucose monitor (is a wearable medical device that tracks the blood sugar levels 24 hours a day without needing constant finger pricks)) to track her blood glucose levels. MD 2 further stated that self‑administering insulin without checking blood glucose could result in serious complications, including hypoglycemic episodes and possible hospitalization. MD 2 stated that no HHA nurse had contacted her or her office for clarification of Patient 10’s insulin orders. During an interview and concurrent record review on 5/11/2026 at 10:56 a.m. with the Director of Quality Management (DQM), Patient 10’s clinical record titled “Patient Medication Record,” was reviewed. The DQM confirmed and stated that medication below is included in Patient 10’s Patient Medication Record: Fiasp FlexTouch subcutaneous 100 unit/ml 20 units inject subcutaneously three times daily (Antidiabetics). During an interview and concurrent record review on 5/11/2026 at 11:14 a.m. with the DQM, Patient 10’s admission record titled “Progress Notes,” dated 3/24/2026 was reviewed. The DQM confirmed and stated that the following medication was not listed in Patient 10’s Progress Note dated 3/24/2026: Fiasp FlexTouch subcutaneous 100 unit/ml 20 units inject subcutaneously three times daily (Antidiabetics).Sacubitril-Valsartan 24-26 mg, Generic for: Entresto, take 1 tablet by mouth, twice a day. During an interview and concurrent record review on 5/11/2026 at 11:36 a.m. with the DQM, Patient 10’s clinical record titled “Home Health Certification and Plan of Care (POC, a written documented created by healthcare professionals and the patient to manage health needs),” with certification period from 4/16/2026 to 6/14/2026, was reviewed. The DQM confirmed and stated that Patient 10’s Home Health Certification and POC dated 4/16/2026 to 6/14/2026, did not include a medication order of: Fiasp FlexTouch subcutaneous 100 unit/ml 20 units inject subcutaneously three times daily (Antidiabetics). Sacubitril-Valsartan 24-26 mg, Generic for: Entresto, take 1 tablet by mouth, twice a day. During an interview and concurrent record review on 5/11/2026 at 11:48 a.m. with the DQM, Patient 10’s electronic medical records (EMR, is a digital, computer-based version of a patient’s paper chart, containing their medical and treatment history within a single healthcare organization), were reviewed. The DQM confirmed and stated that there was no documented physician’s order for the medication: Fiasp FlexTouch subcutaneous 100 unit/ml 20 units inject subcutaneously three times daily (Antidiabetics). Sacubitril-Valsartan 24-26 mg, Generic for: Entresto, take 1 tablet by mouth, twice a day. The DQM stated that RN 2 may have missed to include the Fiasp FlexTouch insulin order and Sacubitril-Valsartan medication in the Home Health Certification and POC submitted to the physician. The DQM stated that standard practice requires the admitting nurse to reconcile all medications on hand with the admission records and, when discrepancies are identified, to contact the healthcare team, including the patient’s physician, to determine whether a medication should be continued and obtained a physician’s order. During an interview on 5/11/2026 at 12:00 p.m., with the DQM, the DQM stated there were no documentations verifying an order for the Fiasp insulin pen and Sacubitril-Valsartan medication from Patient 10’s primary physician. The DQM stated that standard practice requires the HHA nurse to contact the primary physician to clarify the insulin and oral medication orders, including the indication, dose, route, frequency, time of administration, and instructions for when the insulin should or should not be administered. The DQM stated that the clinical record did not reflect when the Fiasp FlexTouch insulin and Sacubitril-Valsartan medication orders were communicated to, or obtained from, the physician. During an interview on 5/11/2026 at 12:10 p.m., with the DQM stated that standard practice requires the HHA nurse to ensure that patients on insulin should be checking the blood glucose level prior to each insulin administration. The DQM stated that if a patient is self-administering insulin medication without checking the blood glucose level first, patient can be at risk of administering the insulin when blood glucose is low that can result to hypoglycemic episodes, hospitalization or could have a detrimental effect that include death. The DQM stated that patients on insulin should be maintaining blood glucose reading logs to monitor effectively if there were any significant changes with the blood glucose readings. The DQM stated that clarifying blood glucose parameters with the physician and incorporating them into the insulin orders would help ensure the patient does not receive an overdose of insulin. Took the word of the patient and did not validate the order Should be every visit – medication reconciliation, look at the med list and go over with the patient if the patient is taking or not, focusing/emphasize on the high risks medications – going over with the current dose or changes, completion on antibiotics including expiration of the medications, if expired the efficacy of the medications is decreased. If med recon not done every visit – overdosing/underdosing, taking medication as ordered by the physician. During an interview and concurrent record review on 5/12/2026 at 11:43 a.m. with RN 2, Patient 10’s clinical records titled, “RN Skilled Nursing Visit” notes dated 4/20/2026, 4/22/2026, 4/24/2026, 4/27/2026, 4/29/2026, 5/1/2026, and 5/4/2026 were reviewed. RN 2 stated and confirmed that these visit notes did not include any documentation indicating communication with Patient 10’s primary care physician to obtain or clarify the orders for the Fiasp insulin pen and Sacubitril-Valsartan medication. During an interview and concurrent record review on 5/12/2026 at 11:55 a.m. with RN 2, Patient 10’s “Physician Order” forms dated 4/20/2026 and 4/27/2026 were reviewed. RN 2 stated and confirmed that these orders did not include documentation of an order for the Fiasp insulin pen and Sacubitril-Valsartan medication. RN 2 stated that during the start‑of‑care visit on 4/16/2026, Patient 10 did not disclose use of the Fiasp insulin pen during medication reconciliation and that he became aware of the medication during the 4/20/2026 visit. RN 2 stated he added the Fiasp insulin pen, including the indication, dose, route, frequency, and time of administration per label instructions, to the medication record. RN 2 stated he should have documented the medication reconciliation in his visit notes and communicated with the physician to clarify and obtain a valid order. RN 2 further stated it was important to confirm with the physician whether the Fiasp insulin pen was intended to be continued and whether the dosage was correct. RN2 stated that Patient 10 did not inform him about her new medication, Entresto, during his last visit on 5/4/2026.”

“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 observation, interview, and record review, the Home Health Agency (HHA, , an organization that delivers skilled nursing and other therapeutics service to a patient at home ) failed to ensure that patients’ clinical records contained complete and accurate physician’s orders and documented clinical notes reflecting communication with the physician for one of seventeen sampled patients (Patient 10). For Patient 10, the HHA failed to obtain a physician’s order from the patient’s primary care physician (MD 2) and failed to transcribe the order into the patient’s Plan of Care for the use of the Fiasp FlexTouch insulin pen (is a pre-filled, disposable insulin pen used to manage blood sugar levels in adults and children with diabetes (a chronic condition where the body does not produce enough insulin (a hormone produced by the pancreas that helps regulate blood sugar levels) or cannot properly use the insulin it produces, leading to high blood sugar levels), and contains a rapid-acting insulin that starts working very quickly, usually within 10–20 minutes to control blood sugar spikes at mealtimes) subcutaneous (situated or occurring directly under the skin, specifically within the fatty tissue layer located between the skin and the muscle), with contain required elements of the insulin order, including indication, dose, route (subcutaneous), frequency, time of administration, and parameters for when the insulin should or should not be administered. This failure had the potential to result in incomplete or inaccurate patient care planning, delays in treatment, medication errors, and inadequate continuity of care. a. During a review of Patient 10’s clinical record titled “Patient Information,” Patient Information indicated Patient 10’s start of care (SOC) date of 4/16/2026 with a primary diagnosis of Type 2 Diabetes mellitus with foot ulcer (an open sore or wound on the foot, often appearing as a crater). During a concurrent observation and record review on 5/8/2026 at 10:20 a.m. with Registered Nurse (RN) 2 at Patient 10’s residence during a joint home visit, the following medications were listed on Patient 10’s clinical record titled “Patient Medication Record,” dated 4/27/2026, and were present in the home: Lantus Solostar (a prefilled, disposable pen used to inject long-acting insulin to manage blood sugar levels in adults and children with diabetes) subcutaneous 100 unit/ml 25 units inject subcutaneously twice daily (Antidiabetics). Fiasp FlexTouch subcutaneous 100 unit/ml 20 units inject subcutaneously three times daily (Antidiabetics). During an interview on 5/8/2026 at 10:45 a.m., with Patient 10, Patient 10 stated she had been using the two insulin pens (Fiasp and Lantus) for several years prior to admission to the HHA. Patient 10 reported that she checks her blood glucose level only once in the morning and not prior to each insulin administration. She stated she self‑administers Fiasp 20 units three times daily and Lantus 20 units twice daily. Patient 10 stated that the HHA nurses did not instruct her to check her blood glucose level before each insulin administration. During an interview on 5/8/2026 at 11:12 a.m., with RN 2, RN 2 stated he conducted Patient 10’s medication reconciliation at start of care. RN 2 stated that insulin medications are high‑risk. RN 2 stated that Fiasp is a fast‑acting insulin that can rapidly lower blood glucose within 15 to 20 minutes after administration, while Lantus is a long‑acting insulin that lowers blood glucose gradually. RN 2 stated that standard practice requires the patient to check blood glucose level prior to insulin administration to ensure it is not low before administering it. RN 2 stated that if Patient 10 is not checking her blood glucose before each administration, Patient 10 is at risk for a hypoglycemic episode that could result in hospitalization or death if left untreated. RN 2 stated that parameters for insulin administration should have been established and communicated to Patient 10’s primary physician to ensure the patient was checking her blood glucose level prior to each insulin self‑administration. During an interview on 5/8/2026 at 11:48 a.m., with Patient 10’s primary physician (MD 2), MD2 stated she has been Patient 10’s physician for several years and had prescribed Fiasp and Lantus for diabetes management. MD 2 stated that Patient 10 is required to check her blood glucose level prior to each insulin self‑administration and to hold the insulin if her blood glucose is below 100 mg/dL. MD 2 stated that Patient 10 was supposed to be using a sensor which is continuous glucose monitor (is a wearable medical device that tracks the blood sugar levels 24 hours a day without needing constant finger pricks)) to track her blood glucose levels. MD 2 further stated that self‑administering insulin without checking blood glucose could result in serious complications, including hypoglycemic episodes and possible hospitalization. MD 2 stated that no HHA nurse had contacted her or her office for clarification of Patient 10’s insulin orders. During an interview and concurrent record review on 5/11/2026 at 10:56 a.m., with the Director of Quality Management (DQM), Patient 10’s clinical record titled “Patient Medication Record,” was reviewed. The DQM confirmed and stated that medications below are included in Patient 10’s Patient Medication Record: Lantus Solostar subcutaneous 100 unit/ml 25 units inject subcutaneously twice daily (Antidiabetics). Fiasp FlexTouch subcutaneous 100 unit/ml 20 units inject subcutaneously three times daily (Antidiabetics). During an interview and concurrent record review on 5/11/2026 at 11:14 a.m. with the DQM, Patient 10’s admission record titled “Progress Notes,” dated 3/24/2026 was reviewed. The DQM confirmed and stated that the following medications were not listed in Patient 10’s Progress Note dated 3/24/2026: Lantus Solostar subcutaneous 100 unit/ml 25 units inject subcutaneously twice daily (Antidiabetics). Fiasp FlexTouch subcutaneous 100 unit/ml 20 units inject subcutaneously three times daily (Antidiabetics). During an interview and concurrent record review on 5/11/2026 at 11:36 a.m. with the DQM, Patient 10’s clinical record titled “Home Health Certification and Plan of Care (POC, a written documented created by healthcare professionals and the patient to manage health needs),” with certification period from 4/16/2026 to 6/14/2026, was reviewed. The DQM confirmed and stated that Patient 10’s Home Health Certification and POC dated 4/16/2026 to 6/14/2026, indicated a medication order of: Lantus Solostar subcutaneous 100 unit/ml 20 units inject subcutaneously twice daily (Antidiabetics). The DQM confirmed and stated that Patient 10’s Home Health Certification and POC dated 4/16/2026 to 6/14/2026, did not include a medication order of: Fiasp FlexTouch subcutaneous 100 unit/ml 20 units inject subcutaneously three times daily (Antidiabetics). During an interview and concurrent record review on 5/11/2026 at 11:48 a.m. with the DQM, Patient 10’s electronic medical records (EMR, is a digital, computer-based version of a patient’s paper chart, containing their medical and treatment history within a single healthcare organization), were reviewed. The DQM confirmed and stated that there was no documented physician’s order for the medication: Fiasp FlexTouch subcutaneous 100 unit/ml 20 units inject subcutaneously three times daily (Antidiabetics). The DQM stated that RN 2 may have missed to include the Fiasp FlexTouch insulin order in the Home Health Certification and POC submitted to the physician. The DQM stated that standard practice requires the admitting nurse to reconcile all medications on hand with the admission records and, when discrepancies are identified, to contact the healthcare team, including the patient’s physician, to determine whether a medication should be continued and obtained a physician’s order. During an interview on 5/11/2026 at 12 p.m., with the DQM stated there was no documentation verifying an order for the Fiasp insulin pen from Patient 10’s primary physician. The DQM stated that standard practice requires the HHA nurse to contact the primary physician to clarify the insulin order, including the indication, dose, route, frequency, time of administration, and instructions for when the insulin should or should not be administered. The DQM stated that the clinical record did not reflect when the Fiasp FlexTouch insulin order was communicated to, or obtained from, the physician. During an interview on 5/11/2026 at 12:10 p.m., with the DQM stated that standard practice requires the HHA nurse to ensure that patients on insulin should be checking the blood glucose level prior to each insulin administration. The DQM stated that if a patient is self-administering insulin medication without checking the blood glucose level first, patient can be at risk of administering the insulin when blood glucose is low that can result to hypoglycemic episodes, hospitalization or could have a detrimental effect that include death. The DQM stated that patients on insulin should be maintaining blood glucose reading logs to monitor effectively if there were any significant changes with the blood glucose readings. The DQM stated that clarifying blood glucose parameters with the physician and incorporating them into the insulin orders would help ensure the patient does not receive an overdose of insulin. Took the word of the patient and did not validate the order. Should be every visit – medication reconciliation, look at the med list and go over with the patient if the patient is taking or not, focusing/emphasize on the high risks medications – going over with the current dose or changes, completion on antibiotics including expiration of the medications, if expired the efficacy of the medications is decreased. If med recon not done every visit – overdosing/underdosing, taking medication as ordered by the physician. During an interview and concurrent record review on 5/12/2026 at 11:43 a.m., with RN 2, Patient 10’s clinical records titled, “RN Skilled Nursing Visit” notes dated 4/20/2026, 4/22/2026, 4/24/2026, 4/27/2026, 4/29/2026, 5/1/2026, and 5/4/2026 were reviewed. RN 2 stated and confirmed that these visit notes did not include any documentation indicating communication with Patient 10’s primary care physician to obtain or clarify the order for the Fiasp insulin pen. During an interview and concurrent record review on 5/12/2026 at 11:55 a.m., with RN 2, Patient 10’s “Physician Order” forms dated 4/20/2026 and 4/27/2026 were reviewed. RN 2 stated and confirmed that these orders did not include documentation of an order for the Fiasp insulin pen. RN 2 stated that during the start‑of‑care visit on 4/16/2026, Patient 10 did not disclose use of the Fiasp insulin pen during medication reconciliation and that he became aware of the medication during the 4/20/2026 visit. RN 2 stated he added the Fiasp insulin pen, including the indication, dose, route, frequency, and time of administration per label instructions, to the medication record. RN 2 stated he should have documented the medication reconciliation in his visit notes and communicated with the physician to clarify and obtain a valid order. RN 2 further stated it was important to confirm with the physician whether the Fiasp insulin pen was intended to be continued and whether the dosage was correct. During a review of HHA’s P&P titled “Contents of the Clinical Record,” revised in November 2020, the P&P indicated the following: A clinical record will be maintained for each patient receiving care. The clinical record will contain sufficient information to identify the patient, describe the patient’s problems and needs, justify care, accurately document care provided and results in detail, and facilitate continuity of care among organization and contract personnel.The following information will be available in the clinical record, as applicable to care and services provided:Legible, complete, and individualized diagnostic and therapeutic orders authenticated within the time frame defined by the organization, or according to law and regulation.Relevant communication to the patient’s physician. During a review of HHA’s P&P titled “Verification of Physician orders,” revised in November 2024, the P&P indicated the following: To ensure that accurate physician (or allowed practitioner) orders and prescriptions are obtained in accordance with state and federal law and regulation.”

“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 interview and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutic services to a patient’s personal residence) failed to provide a documented evidence that the discharge summary was sent to the primary care practitioner or other health care professional responsible for the patient’s post discharge care within five (5) business days of discharge for one of seventeen sampled patients (Patient 17). This failure had the potential to compromise Patient 17’s continuity of care, delay in follow up services and negatively impact Patient 17’s overall health outcome. Findings: During a review of Patient 17’s clinical record titled “Patient Information”, the “Patient Information” indicated Patient 17 had a start of care (SOC) of 11/7/2025, with diagnoses that included cytokine storm (a severe, dangerous overreaction of the immune system where the body releases too many signaling proteins [cytokines] into the blood too quickly. Instead of just fighting an infection, this flood of proteins causes massive inflammation that can damage tissues and lead to organ failure) and immune disorder (a malfunction where the body’s immune system—which normally fights germs—does not work properly). During a review of Patient 17’s clinical record titled “Agency Discharge Report”, dated 12/23/2025, the “Agency Discharge Report” indicated Patient 17 was discharged from HHA services on 12/23/2025 due to out of service area and no available staff. During a concurrent interview and record review on 5/7/2026 at 11:22 am., with the Director of Patient Care Services Designee (DPCS Designee), Patient 17’s clinical record titled “SOC report” dated 11/7/2025 was reviewed. The SOC report indicated Patient 17 was admitted to HHA services for blood draw (a medical procedure where a small amount of blood is taken from a vein, for laboratory testing) and peripherally inserted central catheter (PICC, a thin, flexible tube that delivers treatments through a vein) line dressing changes for management of Patient 17’s immune disorder. The DPCS Designee stated that PICC line dressings should be changed every one to two weeks to prevent infection which could lead to sepsis and rehospitalization. During a concurrent interview and record review on 5/12/2026 at 2:20 pm., with the Director of Quality Management (DQM), Patient 17’s clinical record titled “ Work Log: Agency Discharge Report” dated 12/23/2025 was reviewed. The “Work Log” indicated the “Agency Discharge Report” was sent to Patient 17’s primary physician (MD 1) on 12/23/2025. The DQM stated the “Agency Discharge Report” was sent to MD 1 via fax. The DQM was unable to provide documented evidence that the discharge summary was sent to MD 1. The DQM stated the HHA should include the fax sent receipt to Patient 17’s clinical record or a signed “Agency Discharge Report” by MD 1 that acknowledged receiving the discharge summary to ensure the continuity of care of Patient 17’s PICC line dressing change and routine lab draw. During a review of HHA’s policies and procedures (P&P), titled “Discharge Summary”, revised in November 2024. The P&P indicated a copy of the discharge summary will be provided to the patient’s primary physician who will be responsible for providing care and services to the patient after discharge from the organization within five business days of the patient’s discharge. During a review of HHA’s P&P titled “Contents of the Clinical Record”, revised in November 2020, the P&P indicated the discharge summary and other summary reports sent to the physician, as required by law, regulation, and organization will be available in the clinical record.”