Presbyterian Intercommunity Hospital Home Health

“Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient’s condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This Element is not met as evidenced by: Based on interviews and record reviews, the home health agency (HHA, an organization that delivers skilled nursing and other therapeutic services to a patient’s residence) failed to promptly alert the physician to relevant changes in the patient’s wound condition for one of seventeen sampled patients (Patient 1). This failure had the potential to result in rapid wound deterioration, missed or delayed treatment orders, and an increased risk of infection or systemic decline that could lead to hospitalization. During a review of Patient 1’s Home Health Certification and Plan of Care (POC) for the certification period of 10/3/2025 to 12/1/2025, the POC indicated Patient 1 was admitted to the HHA on 10/3/2025 with diagnoses that included pressure‑induced deep tissue damage of the right heel (a localized injury to the deep muscle and soft tissues beneath intact skin on the right heel), a stage 3 pressure ulcer (an injury involving full‑thickness skin loss extending into subcutaneous tissue), and a stage 2 pressure ulcer of another site (a partial‑thickness loss of the epidermis and dermis). During a review of Patient 1’s routine skilled nursing visit on 10/4/2025, the licensed nurse documented the patient’s right heel wound measurement as 3 centimeters (cm, a metric unit of length) in length, 4 cm in width, and 0.1 cm in depth. During a review of Patient 1’s routine skilled nursing visit on 10/14/2025, a Licensed Vocational Nurse (LVN 2) documented the patient’s right heel wound measurement as 4 cm in length, 6 cm in width, and 0.1 cm in depth. During a record review of Patient 1’s routine skilled nursing visit on 10/4/2026 and 10/14/2026, with the Clinical Director for Home Health (CDHH) on 8/3/2026 at 2:51 PM, the CDHH stated that LVN 2 conducted a routine visit at Patient 1’s residence on 10/14/2025 and documented the wound measurements as 4 cm in length, 6 cm in width, and 0.1 cm in depth, but did not notify the physician of the increase in the right heel wound size. During a telephone interview with LVN 2 on 8/4/2026 at 9:30 AM, LVN 2 stated that he visited Patient 1 on 10/14/2026 and measured the patient’s right‑heel wound. LVN 2 stated that he did not compare the measurements with the previous wound measurements documented by another nurse and were unaware that the right-heel wound had significantly increased in size. LVN 2 stated that had he reviewed the prior measurements and noted the increase, he would have notified the physician and the nursing supervisor. LVN 2 stated that he did not notify the physician during the visit because the patient did not exhibit signs or symptoms of infection. LVN 2 stated that when a patient has a change in condition, the physician and nursing supervisor must be notified immediately because such changes can indicate a serious or potentially life‑threatening problem. LVN 2 stated that immediate notification is crucial, as the patient may be experiencing a rapidly worsening medical condition and any delay can lead to injury, and hospitalization. LVN 2 stated that timely information provided by nursing staff enables the physician to make necessary clinical decisions and treatment adjustments. During an interview and a concurrent record review of Patient 1’s routine skilled nursing visit dated 10/4/2025 to 11/16/2025, with the Interim Director of Patient Care Services (IDPCS) on 8/4/2026 at 2 PM, the IDPCS stated that LVN 2 did not notify the physician of the change in the patient’s right‑heel wound size identified during the 10/14/2025 visit. The IDPCS stated that it is crucial for the nurse to notify the physician of any change in the patient’s condition to ensure appropriate care is provided and to prevent the patient’s health or wound condition from declining. The IDPCS stated that the licensed nurse should review the patient’s orders and care plan prior to a home visit to identify any changes in the patient’s condition requiring prompt physician notification. The IDPCS stated that failing to review the orders prior to a home visit could potentially harm the patient or delay necessary treatment. A review of the facility’s policy and procedure (P&P) titled “Responsibility of the Home Health and Hospice Departments and Physician in the Provision of Medical Care,” Policy #100.86110.009 (revised 10/2/2025), indicated that it is the responsibility of the Home Health department and the physician to collaborate on the care provided to patients referred for Home Health services. The P&P further indicated that clinical staff will keep the physician informed of significant clinical findings during home visits via telephone calls, electronic documentation, and/or written reports. A review of the facility’s P&P titled “Skin Care: Prevention, Treatment, Photograph, and Measuring of Wounds, Pressure Ulcers, and Other Skin Conditions, “ Policy #100.86110.117 (revised 4/4/2025), indicated that the physician will be notified of abnormal findings upon physical skin assessment.”

“Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This Element is not met as evidenced by: Based on interviews and record reviews, the home health agency (HHA, an organization that delivers skilled nursing and other therapeutic services to a patient’s residence) failed to promptly carry out a physician’s wound treatment order for one of seventeen sampled patients (Patient 1). This failure had the potential to result in rapid wound deterioration, missed or delayed treatment orders, and an increased risk of infection or systemic decline that could lead to hospitalization. During a review of Patient 1’s Home Health Certification and Plan of Care (POC) for the certification period of 10/3/2025 to 12/1/2025, the POC indicated Patient 1 was admitted to the HHA on 10/3/2025 with diagnoses that included pressure‑induced deep tissue damage of the right heel (a localized injury to the deep muscle and soft tissues beneath intact skin on the right heel), a stage 3 pressure ulcer (an injury involving full‑thickness skin loss extending into subcutaneous tissue), and a stage 2 pressure ulcer of another site (a partial‑thickness loss of the epidermis and dermis). During a review of Patient 1’s Visit Record dated 10/24/2025, the record indicated in the Daily Progress Notes the following wound care orders for the bilateral heels on 10/24/2025: New wound care orders obtained for bilateral heels. Left heel (DTI): SN/PCG to cleanse with wound cleanser, pat dry, apply Santyl (a prescription topical ointment used to remove dead or damaged tissue from chronic skin ulcers and severe burns) to the wound bed, cover with abdominal pad and rolled gauze, and secure with tape. Perform daily and PRN (as needed). TORB Dr. (telephone order read back to the physician). Right heel (DTI): SN/PCG to cleanse with wound cleanser, pat dry, apply Santyl to the wound bed, cover with abdominal pad and rolled gauze, and secure with tape. Perform daily and PRN. TORB Dr. During a review of Patient 1’s Visit Record dated 10/25/2025, the record indicated that Licensed Vocational Nurse (LVN 3) did not carry out the wound care orders for the bilateral heels during the visit. During an interview and record review of Patient 1’s Visit Record dated 10/24/2025 to 10/25/2025 with the Clinical Director for Home Health (CDHH) on 8/3/2026 at 2:51 PM, the Visit Record dated 10/25/2025 indicated that interventions for the left heel DTI and the right heel DTI were not applicable (not performed). The CDHH stated that LVN 3 conducted a routine visit for Patient 1 on 10/25/2025 but did not carry out the wound care orders from 10/24/2025 for the bilateral heels. During a concurrent interview and record review on 8/4/2026 at 11:00 AM with LVN 3, Patient 1’s Visit Record dated 10/25/2025 was reviewed. LVN 3 stated that prior to conducting a home visit, he usually reviews the patient’s care‑plan charting in the computer the night before. LVN 3 stated he did not carry out the new wound‑care orders for the right and left heel during his visit on 10/25/2025 because the family had already changed the wound dressings on both heels upon his arrival at the patient’s home. LVN 3 stated he decided to carry out the new wound‑care orders the following day, 10/26/2025. LVN 3 stated that it is important to carry out new wound‑treatment orders immediately to ensure proper wound healing and prevent wound infection. During an interview and a concurrent record review of Patient 1’s Visit Record dated 10/24/2025 and 10/25/2025 on 8/4/2026 at 2 PM with the Interim Director of Patient Care Services (IDPCS) , the IDPCS confirmed that LVN 3 did not carry out the new wound‑care orders for the patient’s bilateral heels that were obtained on 10/24/2025 during the 10/25/2025 visit. The IDPCS stated that the licensed nurse should review the patient’s orders and care plan prior to a home visit to ensure all physician orders are carried out immediately and that interventions provided match the individualized care plan. The IDPCS stated that failing to review the orders prior to a home visit could potentially harm the patient or delay necessary treatment. A review of the facility’s policy and procedure (P&P) titled “Licensed Vocational Nursing Services,” Policy #100.86110.106 (revised 4/3/2026), indicated that Licensed Vocational Nurses (LVNs) provide care under the supervision of a Registered Nurse (RN) in accordance with the plan of care prescribed by a physician, and that LVNs carry out the services prescribed on the plan of care as instructed by the RN.”

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to ensure one of 10 sampled patients (Patient 23), who had a diagnosis of diabetes (DM-a disorder characterized by difficulty in blood sugar control and poor wound healing), did not self-administer insulin (a hormone that removes excess sugar from the blood, can be produced by the body or given artificially via medication) without a physician’s order. -Patient 23 did not have a physician order for the Humalog Kwikpen insulin lispro (a pre-filled, disposable insulin pen that delivers rapid-acting insulin) that indicated the dose, route, frequency, time of administration and instruction when to take or not take the medication. -Patient 23 did not have physician order for Tresiba Flex Touch (a pre-filled, disposable insulin pen that contains long-acting insulin to help lower blood sugar levels in people with diabetes) that indicated the dose, route, frequency, time of administration and instruction when to take or not take the medication. -HHA did not follow the Hospital Discharge Instructions for Patient 23 to use Humalog home sliding scale (refers to a method of adjusting insulin dosages based on blood sugar levels). Patient 23 had to pick and choose on her own how much insulin she should self-administer. As a result of the noncompliance Patient 23 was at increased risk of hypoglycemic (low blood sugar) and hyperglycemic (high blood sugar) episodes with regards to administering unprescribed doses of insulin. Patient 23 was also at risk for ineffective drug therapy, noncompliance with drug therapy, and adverse drug reactions that could lead to serious harm, hospitalization and death. On 7/10/2025, at 12:10 p.m., the 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) in the presence of the agency’s Director of Patient Care Services (DPCS) , Registered Nurse (RN) Clinical Directors, Director of Performance Outcomes, Vice President of Post-Acute Care, and Accreditation and Licensing Coordinator, Director of Finance related to the home health agency’s failure as follows: -Patient 23 did not have a physician order for the Humalog Kwikpen and Tresiba Flex Touch that indicated the dose, route, frequency, time of administration and instruction when to take or not take the Humalog Kwik pen and Tresiba Flex Touch. -HHA did not follow the Hospital Discharge Instruction for Patient 23 to use Humalog home sliding scale. Patient 23 had to pick and choose on her own how much insulin she should self-administer. On 7/10/2025, at 12:20 p.m., the survey team completed the survey tasks and conducted an exit conference while onsite in the presence of the DPCS, Vice President of Regulatory Affairs, RN Clinical Directors, Director of Performance Outcomes, Vice President of Post-Acute Care, and Accreditation and Licensing Coordinator. On 7/10/2025 at 3 p.m., the HHA failed to submit an IJ removal Plan (includes all actions the agency has taken or will take to immediately address the noncompliance that resulted in or made serious injury, serious harm, serious impairment, or death likely). The survey team exited the HHA with the IJ not removed. Findings: During a review of Patient 23’s medical record titled, “Patient Information,” the record indicated that Patient 23, with a start of care (SOC) date of 7/6/2025, had primary diagnosis of chronic obstructive pulmonary disease (a common lung disease causing restricted airflow and breathing problems), and secondary diagnosis of type 2 diabetes mellitus. During a review of Patient 23’s medical record titled, “Home Health Certification and Plan of Care (POC, consists of different patient goals, nursing and allied health assessment and interventions to help attain those goals, and expected outcomes aligned with the patient’s needs) with an initial certification of period date from 7/6/2025 to 9/3/2025, the record did not indicate the following medications under the “section 10: Medications: Dose/Frequency/Route (N) New (C) Changed: -Humalog Kwikpen insulin lispro indicated no label. -Tresiba Flex Touch indicated no label. During further review of Patient 23’s “Home Health Certification and Plan of Care” from 7/6/2025 to 9/3/2025 indicated the following: -Patient/caregiver will state understanding of disease process, need to control blood sugar and potential complications if blood sugar not maintained within identified parameters. -Decreased number of hospitalizations/ER (Emergency Room) visits related to diabetes symptoms. -Instruct administration of injectable medications. -Instruct in new or changed meds – use, actions, side effects. -Instruct in side effects to report to RN/MD (Medical Doctor). -Instruct in risk for hospitalization/ER (emergency room) visits related to diabetes symptoms. During a concurrent observation and record review on 7/7/2025, at 9 a.m., with RN 11 and Clinical Director (CD) 3, in Patient 23’s residence for a joint home visit, Patient 23 was comfortably resting in her chair, alert, awake and oriented to her name, time, place and events. During a medication reconciliation review (the process of comparing a patient’s medication orders to all of the medications that the patient has been taking) of Patient 23’s medications with RN 11, the following medications were not listed on Patient 23’s medication list but were observed included in Patient 23 medications on hand: -Humalog Kwikpen (no label). -Tresiba Flex Touch (no label). During an interview on 7/7/2025, at 9:15 a.m. with Patient 23 stated, that she checked her blood sugar level using her glucometer (a small, portable electronic device used to measure the amount of glucose [sugar] in a blood sample) four to five times a day before meals and after meals at random. Patient 23 stated that she started using her insulin (Humalog and Tresiba) medication prior to HHA admission (unable to say exact date) and her endocrinologist (a medical doctor who specializes in diagnosing and treating conditions related to glands that make hormones) prescribed the Humalog Kwikpen and Tresiba Flex Touch insulin medications to her but did not provide any instructions on how many units of insulin to administer for the blood sugar readings she may have. Patient 23 stated that she administered insulin to herself if her blood sugar level was above 250 to 300 mg/dl (milligram per deciliter-unit of measurement). Patient 23 stated that she picks and chooses on how many units of insulin she should administer to herself because she did not have any instructions or sliding scale (refers to a method of adjusting insulin dosages based on blood sugar levels) to follow. Patient 23 stated that her blood sugar reading last night (7/7/2025) at 6 p.m., after meals was 300 mg/dl and she self-administered 20 units (unit of measurement) of Tresiba Flex Touch and 25 units of Humalog Kwik pen. During an interview on 7/7/2025, at 9:25 a.m., with RN 11 stated, that she did an initial visit to Patient 23 on 7/6/2025 and conducted a medication reconciliation which she noticed that the Humalog Kwikpen and Tresiba were in Patient 23’s medications but did not indicate any sliding scales, instructions or parameters for administration. RN 11 stated she did not call Patient 23’s primary doctor because it was the weekend and the office was closed. RN 11 stated that she did not report it to the DPCS and CD 3. RN 11 stated that during her visit, Patient 23’s blood sugar was stable and did not present any signs and symptoms of hypoglycemia. RN 11 stated that the Humalog Kwikpen and Tresiba Flex Touch did not reflect Patient 23’s active medication list because she did not synchronize her data yet from her end and new medications are keep coming out. During a telephone interview and concurrent record review on 7/7/2025, at 3:36 p.m., Patient 23’s hospital discharge instruction dated 7/5/2025 were reviewed. RN 11, DPCS and CD 3 stated that they were not aware of the medication reconciliation discrepancy that Patient 23 was taking the Humalog and Tresiba but the medications were not on Patient 23’s medication active list until 7/8/2025. The DPCS stated that if the visiting nurse was unable to get hold of the doctor for an urgent matter, the visiting nurse must follow the chain of command and must escalate the concerns to the clinical director then to the DPCS. RN 11 stated that she visited Patient 23 on 7/7/2025 at around 9 a.m., Patient 23’s blood sugar level was stable and did not present any signs and symptoms of hypoglycemia, RN 11 stated that since there was no sense of urgency and she needed to prioritize her tasks for the day, she attempted to call the doctor on 7/7/2025 around 2 p.m., to 3 p.m., to clarify orders or any instructions, parameters or sliding scales regarding Patient 23’s Humalog Kwik pen and Tresiba Flex Touch but was unsuccessful to speak to the physician. RN 11 stated that on Patient 23’s hospital discharge instruction prior to HHA admission on 7/6/2025 indicated that “Humalog to continue home sliding scale” and Tresiba did not indicate any number of units to administer. RN11 stated that insulin was a high-risk medication and that was why she attempted to call Patient 23’s primary doctor to clarify orders. The DPCS stated that insulin medication was a high-risk medication and if it was administered with wrong dosages, it could result in hyperglycemic or hypoglycemic episodes. During an interview on 7/9/2025, at 12:30 p.m., with the DPCS stated that the visiting nurse attempted to call Patient 23’s primary care physician on 7/7/2025 around 2 p.m. to 3 p.m. but was unsuccessful. The DPCS stated that since RN 11 has no significant findings regarding Patient 23, then the agency gives 24 hours for the primary physician to call back and if not then they escalate it to the specific medical directors outside clinic. During a review of Patient 23’s hospital records titled “Patient Medication Discharge Instructions,” dated 7/5/2025, the Patient Medication Discharge Instruction included: -Humalog Kwikpen 100 units/ml (milliliter, unit of weight) injectable three times a day (after meals) per sliding scale. -Patient 23’s patient medication discharge instructions did not indicate Tresiba Flex Touch. During an interview on 7/10/2025, at 10:38 a.m., with the DPCS stated that the process of admission from hospital discharge was that the visiting nurse should be transcribing the medications from the hospital discharge instructions and will need to call in to the primary doctor for verification if the patient’s medications from the hospital’s discharge instructions needed to be continued or not. The DPCS stated that during admission of Patient 23 on 7/6/2025, RN 11 was working on getting those medications into the electronic medical record and transcribe the active medication list. The DPCS stated that patient’s active medication list would also reflect to the patient’s plan of care. The DPCS stated that the Humalog and Tresiba insulins were not included in Patient 23’s active medication list because there was a discrepancy and was still in the process of clarification from the doctor. The DPCS stated that because there was a discrepancy then it will be hold off until it was clarified with the doctor. The DPCS stated that the reason why the insulin medications were not listed in the active medication list was because RN 11 was still working on it and once it gets finalized after the five-day window and then it gets printed and sent to the to the physician to sign and it will be up to date. The DPCS stated that once the medications from the patient’s hospital discharge instructions were transcribed, the nurse must contact the primary doctor to verify which one the patient needs to keep for the medications and what medications need to be discontinued. The DPCS stated that if there were clarifications regarding medications, then it needed to be made with the doctor as soon as possible. The DPCS stated that Patient 23 was admitted to HHA on 7/6/2025, Sunday, which falls on the weekend. The DPCS stated RN 11 should have contacted the doctor to verify if all of Patient 23’s medications needed to be continued from the discharge instructions from the hospital, however, in the nursing team’s experience, it come across to difficulties getting hold of the doctors at times especially on the weekends and there were doctors on call but the doctors only wanted to deal with what they considered urgent matters. The DPCS confirmed and stated that there was no documentation that RN 11 called the doctor during Patient 23’s admission to HHA on 7/6/2025 to verify medications including insulin medications. During an interview on 7/10/2025, at 8:53 a.m., with the Medical Director (MD), the MD stated that he is the Medical Director of General Acute Hospital that oversees the outpatient clinics, home health and hospice agencies. The MD stated that the nursing staff contacts him if they were unable to get hold of the primary doctors for any concerns related to patients. The MD stated that if the nurses needed an order clarification, physician’s orders, discrepancies, instructions or concerns including insulin medications, the visiting nurse should contact the primary doctor immediately. The MD stated that the outpatient clinics were closed on weekends but there was an available on-call doctor 24 hours/ seven days a week for any concerns that need to be addressed regarding patients. The MD stated that Patient 23 was a long-term insulin dependent since 2023 for the Humalog Kwik pen and year 2021 for Tresiba Flex Touch and needs to continue such treatment to continue to control her blood sugar levels. The MD stated that the visiting nurse should call the on-call doctor for clarifications, obtaining physician’s orders and address discrepancies on the same day of admission and not the following day since insulin was a high-risk medication and it could result in hypoglycemia if a patient was administered a wrong dose. During a review of the HHA’s policy and procedure (P&P) titled “Conformance with Physician Orders,” with a revised date of 4/1/2025, the P&P indicated the following: -Staff providing patient care will access the patient’s medical record to determine what treatments, interventions and medications are ordered. -The clinician providing the care during each visit will determine what is required for patient via review of care plan, medication profile, physician orders and previous clinical and progress notes. -The professional staff will obtain physician orders for any changes in medications, treatments, and/or procedures.”

“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 therapeutic services to a patient’s personal residence, rather than in a more traditional healthcare facility setting) failed to meet the Condition of Participation for Comprehensive Assessment of Patients as follows: 1. The HHA failed to review all the medications and update the medication profile with the currently used medications for three of seventeen sampled patients (Patient 2, Patient 6, and Patient 16). This deficient practice had the potential to put the patient at risk for medication errors and adverse drug reactions. (Refer to G536). 2. The HHA failed to conduct a consistent update of reassessments of wounds and peritoneal dialysis access (the method used to introduce a cleansing fluid (dialysate) into the abdominal cavity, where it can filter waste and excess fluid from the blood, it involves a soft tube surgically placed in the abdomen, through which the dialysate is infused and drained) were documented for three of seventeen sampled patients (Patient 1, Patient 11, Patient 16, and Patient 17). This failure had a potential risk to patients not being properly evaluated and could result to the patients not being provided individualized focused care. (Refer to G544). 3. The HHA failed to ensure a discharge assessment summary was completed and provided a copy of discharge notification and instructions to two of seventeen sampled patients (Patient 10 and Patient 14). This deficient practice resulted in the HHA without assessing and identifying the needs of patients/patients’ family and caregivers to ensure the provision of quality health care services when discharged from care and services. (Refer to G550). 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.”

“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 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, and quality of care was met as follows: a. The Home Health Agency (HHA) failed to follow the plan of care for three of six patients (Patients 1, Patient 11, Patient 16 and Patient 17). For Patient 1, the skilled nurse visits were not performed as ordered. For Patient 1, 11 and Patient 17, the weekly wound measurement was not performed. For Patient 16, the daily peritoneal dialysis access (the method used to introduce a cleansing fluid [dialysate] into the abdominal cavity, where it can filter waste and excess fluid from the blood, it involves a soft tube surgically placed in the abdomen, through which the dialysate is infused and drained) was not performed. These failures had the potential for Patient 1, Patient 11, Patient 16, and Patient 17 not to receive adequate care based on their individual needs. (refer to G572) b. the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to develop an individualized plan of care (POC, a document detailing a patient’s health needs, created by a healthcare team based on a comprehensive assessment of the patient’s condition and goals, outlining interventions and expected outcomes to be achieved) that includes management of potential problems, interventions, and goals for safety precautions while on anti-coagulant (blood thinner medication that can cause serious bleeding) medication for one of seventeen sampled patients (Patient 17). This deficient practice resulted in patient with no specific formulated POC for the current health status for management of symptoms that are likely to cause delayed care, undetected adverse signs and symptoms of medication. (refer to G574) c. the HHA failed to revise one of seventeen sampled patients’ (Patient 1) Plan of Care (POC- a document detailing a patient’s health needs, created by a healthcare team based on a comprehensive assessment of the patient’s condition and goals, outlining interventions and expected outcomes to be achieved) to reflect Patient 1’s ongoing and monitoring of loose stools. This deficient practice had the potential to delay necessary interventions to achieve Patient 1’s goals and outcomes in resolving the loose stools, that could have caused a decline in her overall health. (refer to G592) d. the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutic services to a patient’s personal residence, rather than in a more traditional healthcare facility setting) failed to ensure that education and training were provided to the patient/patient’s caregiver related to bleeding precautions while on anti-coagulant medication (medication that is used to prevent and treat blood clots in blood vessels and the heart) for one of seventeen sampled patients (Patient 17). This failure resulted in the HHA’s inability to ensure the patient’s/patient caregiver’s understanding of possible risks, safety precautions, and side effects of medication. (refer to G610) e. the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutic services to a patient’s personal residence, rather than in a more traditional healthcare facility setting) failed to provide a copy of a recent, updated Plan of Care (POC- a document detailing a patient’s health needs, created by a healthcare team based on a comprehensive assessment of the patient’s condition and goals, outlining interventions and expected outcomes to be achieved) for three of seventeen sampled patients (Patient 2, Patient 3, Patient 16 and Patient 17). This deficient practice had the potential to cause the patient and/or the family/caregiver to not be aware of their treatment plan, the services provided and be an active participant in their care planning process. (refer to G612) The Home Health Agency (HHA- an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to ensure that the physician was promptly alerted to relevant changes in the patient’s condition for one of seventeen sampled patients (Patient 1), when: Patient 1 had episodes of loose stools (your bowel movements are softer, more watery, or shapeless than usual) as indicated on the visiting nursing notes dated 12/20/2024, 12/21/2024, and 12/22/2024. Family Member 1 (FM1) reported on 12/24/24 at 8:40 p.m. that Patient 1 had an episode of low blood pressure (BP- force exerted by circulating blood against the artery [blood vessels that carry oxygen-rich blood away from the heart to the rest of the body] walls. Normal blood pressure is considered to be less than 120 over (/) 80 millimeters of mercury (mmHg-unit of measure) noted at 72/53 mmHg; and an elevated heart rate (HR- number of times your heart beats per minute, normal heart rate is 60 beats per minute [BMP] to 100 beats per minute) of 138 bpm.As a result, this deficient practice, of not notifying the physician of Patient 1’s Change of Condition (COC- any change in a person’s physical, mental, or behavioral state that is not the normal course of their daily routine or expected progress) of continuous episodes of loose stools for three (3) days on 12/20/2024, 12/21/2024, and 12/22/2024, and an episode of low blood pressure of 72/53 mmHg and heart rate of 138 bpm on 12/24/2024, resulted in the delay of care and treatment for Patient 1, which resulted in further decline of the patient’s condition requiring a call to 911 (an emergency number that provides emergency assistance). Patient 1 required an emergency transfer via ambulance to General Acute Care Hospital (GACH1), Patient 1 was given fluid bolus (a rapid infusion of a relatively large volume of fluid, typically administered intravenously (IV- directly into a vein), to quickly restore fluid volume and address conditions like hypovolemia [low blood volume] or hypotension [low blood pressure]. It’s often used in emergency situations or when immediate fluid replacement is needed) and was admitted to GACH 1 further treatment on 12/25/2024; and expired on 12/30/2024. (Refer to G590) The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated (written law) compliance with Federal regulation for compliance with Care planning, coordination, and quality of care which are provided to the patients who are assessed to receive home health care services.”

“Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This Condition is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to ensure the Condition of Participation (conditions that health care organizations must meet in order to begin and continue participating in the Medicare and Medicaid programs) for skilled professional services was met as follows: 1. The HHA nursing staff failed to ensure the physician was promptly alerted to relevant changes in the patient’s condition for one of seventeen sampled patients (Patient 1). This failure resulted in Patient 1’s delayed care and hospitalization for further treatment. (Refer to G704). 2. The HHA nursing staff failed to conduct a consistent update of reassessments of wounds and peritoneal dialysis access (the method used to introduce a cleansing fluid (dialysate) into the abdominal cavity, where it can filter waste and excess fluid from the blood) were documented, per patient’s plan of care (POC, a document detailing a patient’s health needs, created by a healthcare team based on a comprehensive assessment of the patient’s condition and goals, outlining interventions and expected outcomes to be achieved) for four of seventeen sampled patients (Patient 1, Patient 11, Patient 16, and Patient 17). For Patient 1, Patient 11, and Patient 17, the weekly wound measurement was not performed. For Patient 16, the daily peritoneal dialysis access (the method used to introduce a cleansing fluid [dialysate] into the abdominal cavity, where it can filter waste and excess fluid from the blood, it involves a soft tube surgically placed in the abdomen, through which the dialysate is infused and drained) assessment was not performed. This failure placed Patient 1, Patient 11, Patient 16, and Patient 17 delayed wound healing, decline and unmonitored progression or worsening condition that could result in hospitalization. (Refer to G706). 3. The HHA nursing staff failed to ensure that education and training were provided to the patient/patient’s caregiver related to bleeding precautions while on anti-coagulant medication (medication that is used to prevent and treat blood clots in blood vessels and the heart) for one of seventeen sampled patients (Patient 17). This failure resulted in the patient’s/patient caregiver’s lack of understanding of possible risks, safety precautions, and side effects of anti-coagulant medication. (Refer to G714). The cumulative effect of this systemic practice resulted in the failure of the HHA to deliver statutorily (decided and controlled by law) mandated compliance with federal regulation for skilled professional services to ensure quality patient care was provided to the patients.”

“Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient’s condition warrants due to a major decline or improvement in the patient’s health status, but not less frequently than- This Standard is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to conduct a reassessment per patient’s plan of care (POC, a document detailing a patient’s health needs, created by a healthcare team based on a comprehensive assessment of the patient’s condition and goals, outlining interventions and expected outcomes to be achieved) for three of seventeen sampled patients (Patient 1, Patient 11, Patient 16, and Patient 17). 1. For Patient 1, Patient 11 and Patient 17, the weekly wound measurement was not performed. 2. For Patient 16, the daily peritoneal dialysis access (the method used to introduce a cleansing fluid [dialysate] into the abdominal cavity, where it can filter waste and excess fluid from the blood, it involves a soft tube surgically placed in the abdomen, through which the dialysate is infused and drained) assessment was not performed. This deficient practice placed the patient at risk for delayed care, decline, and unmonitored progression or worsening condition. Findings: a. During a review of Patient 1’s Patient Information Sheet (face sheet, admission record), the Patient Information Sheet indicated Patient 1’s Start of Care (SOC) date of 12/4/2024, with primary diagnosis of Pulmonary embolism without acute cor pulmonae (blood clots in the lungs without causing enlargement of the right side of the heart). During a review of Patient 1 ‘s medical record form titled Home Health Certification and Plan of Care (POC) for the certification period of 12/4/2024 to 2/1/2025, the POC indicated an order for frequency of visit from Skilled Nurses, two times a week for one week and three times a week for eight weeks. The POC indicated skilled nurse (SN) to assess wounds for changes every visit and measure wounds for depth, width and length weekly. During a concurrent interview and record review on 5/21/2025 at 2:54 pm., with Registered Nurse (RN) Clinical Director 3 (CD3), Patient 1’s visit calendar schedule for the month of December 2024 was reviewed. Patient 1’s visit calendar schedule for the month of December 2024 indicated the date of 12/9/2024 had a grey rectangle with the letters SN. CD3 stated a grey rectangle indicated that the home visit for that date was not done and stated the letters SN stood for skilled nurse. The grey rectangle for the date of 12/9/2024 on Patient 1’s visit schedule calendar further indicated a note by Registered Nurse 6 (RN6) indicating that the visit with Patient 1 was confirmed in advance and when RN6 arrived patient was not feeling well and visit was declined. CD3 stated and confirmed that the home visit for 12/9/2024 was not conducted. CD3 stated and confirmed that for the week of 12/8/2024 to 12/14/2024 there was no documentation that a home visit was offered or conducted for Patient 1. CD3 stated if a home visit is missed or declined the skilled nurses should attempt to reschedule the home visit that same week and document the outcome. CD3 stated for the week of 12/8/2024 to 12/14/2024 there were no nursing home visits conducted per physician orders of 2 times week. During a concurrent interview and record review on 5/21/2025 at 3:35 pm., with CD3, Patient 1’s medical records titled Home Health/Hospice Nursing Assessment were reviewed. Patient 1’s Home Health/Hospice Nursing assessments dated 12/22/2024, 12/23/2024 and 12/24/2024 indicated documentation that the skilled nurses performed wound care and treatment for Patient 1’s wounds but did not have documented evidence of wound measurements completed for that week. CD3 stated and confirmed that for the week of 12/22/2024 when the Skilled Nurses performed home visits for Patient 1, the Home Health/Hospice Nursing Assessment’s dated 12/22/2024, 12/23/2024, and 12/24/2024 did not have documentation indicating that the wounds were measured. CD3 stated the HHA skilled nurses are to measure wounds weekly per policy. During a concurrent interview and record review on 5/22/2025 at 1:56 pm., with Registered Nurse 2 (RN2), Patient 1’s medical record titled Home Health/Hospice Nursing Assessment dated 12/23/2024 was reviewed. Patient 1’s clinical record indicated RN2 was the author of the assessment dated 12/23/2024. RN2 stated and confirmed she was the author of the nursing assessment dated 12/23/2024 and she performed wound care for Patient 1 as ordered by the physician. RN2 stated she is part of the wound care team for the HHA. RN2 stated patient’s wounds are to be photographed on admission, discovery, recertification, resumption of care, with any significant changes, on discharge, and are to be measured weekly. RN2 stated and confirmed she did not document wound measurements for Patient 1’s wounds on her home visit for 12/23/2024. During a concurrent interview and record review on 5/22/2025 at 2:06 pm., with the DPCS, Patient 1’s medical records titled Home Health/Hospice Nursing Assessment dated 12/22/2024, 12/23/2024, and 12/24/2024 were reviewed. The DPCS stated per HHA policy, the skilled nurses are to assess wounds at every visit, photograph the wounds upon admission, recertification, resumption of care, discovery of wound and on discharge. The DPCS stated wounds are measured weekly. The DPCS stated and confirmed Patient 1’s Home Health/Hospice Nursing Assessment’s dated 12/22/2024, 12/23/2024, and 12/24/2024 did not include documentation of the wounds being measured for that week visit period. The DPCS stated it is important for patients with wounds to be assessed upon every visit and have weekly measurements so that the skilled nurses and care team have clinical oversight of the treatment and see if it is working for the patient, assess how well patient’s wounds are healing and be able to communicate this with the physician. The DPCS further stated the wound measurements are documented on the nursing assessment under the section skin/wound assessment. b. During a review of Patient 11’s Patient Information Sheet, the Patient Information Sheet indicated Patient 11’s start of care (SOC) date of 10/23/2024, with primary diagnosis of a Stage 4 (full thickness tissue loss with exposed bone, tendon, or muscle) pressure ulcer of the right hip (also tuberosity) and a Stage 4 pressure ulcer to the sacral (the large, triangular bone at the base of the spine) region. During a review of Patient 11 ‘s Home Health Certification and Plan of Care (POC) for the certification period from 4/21/2025 to 6/19/2025, the Home Health Certification and POC indicated to measure wounds for depth, width, and length weekly. During a concurrent observation and interview on 5/21/2025 at 10:30 a.m., in Patient 11’s bedroom, with RN 9, RN 9 performed wound care and treatment, but did not perform wound measurements. RN 9 stated that wound measurements were performed once a week. During a concurrent interview and record review on 5/21/2025 at 3:25 p.m., with the Registered Nurse Clinical Director (CD2), of Patient 11’s Nursing Routine Visit notes from 4/6/2025 through 5/12/2025, the Nursing Routine Visit notes did not indicate that wound measurements were performed weekly. The CD2 stated that there were no weekly wound measurements for Patient 11’s stage 4 pressure ulcer to the right ischial tuberosity (hip) for the weeks of 4/13/2025, 4/27/2025 and 5/4/2025 and stage 4 pressure ulcer to the sacrum for the weeks of 4/13/2025 and 5/4/2025. During an interview on 5/23/2025 at 11:23 a.m., with CD2, CD2 stated that Patient 11’s wounds should have been measured and documented weekly within the assessment. CD2 stated that it was important that the wound be measured weekly to show the progress or lack of progress of the wound healing, and if the wound treatment was not working, we would notify the physician for an updated plan of care for the wound care order which could include the wound care treatment, the materials or product used, or change the frequency of the visits for wound care. c. During a review of Patient 16’s “Patient Information” indicated a latest admit date of 6/4/2024, current certification period of 3/31/2025 to 5/29/2025, with a primary diagnosis of pressure ulcer (damage to the skin and underneath caused by prolonged pressure) of sacral region (or sacrum, is at the bottom of the spine and lies between the fifth segment of the lumbar spine (L5) and the coccyx (tailbone), it is a triangular-shaped bone and consists of five segments (S1-S5) that are fused together), stage 3 (a wound where the skin is broken all the way through, exposing the underlying fat tissue, appears like a crater with the fat visible at the bottom). During a review of Patient 16’ s “Home Health Certification and Plan of Care (POC, a detailed written document outlining the patient’s specific needs, including skilled nursing care, rehabilitative, and supportive care provided to a patient at home) for the certification period starting from 3/31/2025 to 5/29/2025, the POC included an order for the skilled nurse (SN) to: -Assess for signs and symptoms of infection Q (every) visit. -Assess signs and symptoms of peritoneal dialysis site problems to include: redness, swelling, pain, tenderness, bleeding every visit. -Measure wounds for depth, width, length weekly. During a concurrent observation and interview on 5/21/2025, at 10:12 a.m., with the Registered Nurse (RN4) and Clinical Director (CD), in Patient 16’s residence for a joint home visit, Patient 16 was comfortably resting in her bed, alert, awake and oriented to his name, time, place and events. Patient 16 has a caregiver (CG), she stated that she takes care of the patient 5 days a week, during daytime, and the patient’s family takes care of her (Patient 16) at nighttime. RN conducted hand hygiene, then performed an assessment of Patient 16’s wound of sacral region. RN stated that Patient 16’s wound of sacral region is categorized as stage 3 pressure ulcer. Patient 16’s wound of sacral region has no active bleeding, no yellow discharge and no foul odor. RN stated that visiting nurses measure the wound by depth, width, and length, of sacral region every week per POC order. RN stated that she did not measure Patient 16’s wound of sacral region during visit since the visiting nurse measured it on last Monday’s visit (5/19/2025). RN stated that nursing teams visit Patient 16 three times a week for wound care. RN performed wound care to Patient 16’s pressure ulcer of sacral region with the current treatment order, Patient 16 tolerated it well and has no complaint of pain. Patient 16 was observed with clean, dry and non-saturated dressing on her right lower abdominal area. RN stated that it is Patient 16’s peritoneal dialysis access. RN stated that Patient 16 had peritoneal dialysis access to her right lower abdomen since she was admitted to HHA services. RN stated that she has dialysis treatment (a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly) three times a week from an outpatient dialysis center and her (Patient 16) most recent dialysis treatment was yesterday (5/20/2025), CG confirmed it. RN stated that she does a visual assessment of peritoneal dialysis access on each visit. RN stated that she assesses for any signs and symptoms of infection like pain, redness, unusual discharges from Patient 16’s peritoneal dialysis access on her each visit. RN stated that the dialysis center nurse manages the dressing of it. During a concurrent interview and record review on 5/23/2025 at 11:35 a.m., with the CD of Patient 16’s electronic medical records, titled “SN (Skilled Nursing) Routine Visit,” dated week of 4/13/2025 to 4/19/2025 and week of 4/20/2025 to 4/26/2025, CD confirmed and stated that there is no documented evidence of Patient 16’s pressure ulcer of sacral region measurement by depth, width, and length. CD stated it is important to measure patient’s wounds as part of the assessment to compare previous and current measurements to determine the progression, improvement or worsening of the wound. CD stated that it is important to measure the wound as it is specified in patients’ POC as part of reassessment. During a concurrent interview and record review on 5/23/2025 at 11:35 a.m. with the CD of Patient 16’s electronic medical records, titled “SN (Skilled Nursing) Routine Visit,” dated 5/4/2025, 5/7/2025, 5/14/2025, 5/17/2025, and 5/18/2025, CD confirmed and stated that there is no documented evidence of Patient 16’s peritoneal dialysis access assessment as per POC indicated to assess signs and symptoms of peritoneal dialysis site problems to include: redness, swelling, pain, tenderness, bleeding every visit. CD stated it is important to follow the POC to assess Patient 16’s peritoneal dialysis access to determine the site’s appearance and to ensure that there are no signs and symptoms of infection. d. During a review of Patient 17’s “Patient Information” indicated a latest admit date of 4/25/2025, current certification period of 4/25/2025 to 6/23/2025, with a primary diagnosis of non-pressure chronic ulcer (a long-lasting open sore or wound that does not heal properly and is not caused by sustained pressure or friction) of right calf (muscle at the back of lower leg) with fat layer exposed. During a review of Patient 17’ s “Home Health Certification and Plan of Care (POC, a detailed written document outlining the patient’s specific needs, including skilled nursing care, rehabilitative, and supportive care provided to a patient at home) for the certification period starting from 4/25/2025 to 6/23/2025, the POC included an order for the skilled nurse (SN) to: -SN to cleanse the right posterior (back) calf diabetic ulcer (wound that is slow to heal, and is a complication of diabetes (disease which presents uncontrolled blood sugar level)) with Vashe (a wound cleanser), pat dry, apply medihoney (ointment or cream that treats local wound bed infection or reducing increased bacteria levels) to the wound bed, cover with a sterile 4 x 4 gauze and reinforce with Turbigrip (elastic and pressure bandage) D 3 x a week for 60 days. -Measure wounds for depth, width, length weekly. During a concurrent interview and record review on 5/23/2025 at 11:55 a.m., with the CD of Patient 17’s electronic medical records, titled “SN (Skilled Nursing) Routine Visit,” dated week of 4/27/2025 to 5/3/2025, CD confirmed and stated that there is no documented evidence of Patient 17’s right posterior calf diabetic ulcer’s measurement by depth, width, and length. CD stated it is important to measure patient’s wounds as part of the assessment to compare previous and current measurements to determine the progression, improvement or worsening of the wound. The CD stated that it is important to measure the wound as it is specified in patients’ POC as part of reassessment and to determine if current treatment is effective or need to be changed. During a review of the facility’s policy and procedure (P&P), titled “Skin Care: Prevention, Treatment, Photograph, and Measuring of Wounds, Pressure Ulcers, and Other Skin conditions,” dated 4/4/2025, the P&P indicated there will be individualized patient care focused specifically on personal hygiene of the skin with evaluation of the individual patient’s risk for skin injury. The P&P shall include basic procedures as defined in this policy for initiation and carrying out of preventive and early interventions. The P&P indicated that assessment of abnormal skin findings will be performed at every visit and dressing change, as appropriate, and documented in the electronic medical record (EMR). The P&P indicated documentation will include the following: 1. Location and/or stage of pressure injury 2. Weekly measurement of wound(s) length x width x depth and extent of undermining and tunneling (if present), using centimeters 3. Color of wound bed 4. Condition of periwound skin 5. Wound edges 6. Presence/absence of exudate and odor 7. Presence of granulation tissue and/or epithelialization”

“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) failed to follow the plan of care for three of six patients (Patients 1, Patient 11, Patient 16 and Patient 17). For Patient 1, the skilled nurse visits were not performed as ordered. For Patient 1, 11 and Patient 17, the weekly wound measurement was not performed. For Patient 16, the daily peritoneal dialysis access (the method used to introduce a cleansing fluid [dialysate] into the abdominal cavity, where it can filter waste and excess fluid from the blood, it involves a soft tube surgically placed in the abdomen, through which the dialysate is infused and drained) was not performed. This deficient practice had the potential for Patient 1, Patient 11, Patient 16, and Patient 17 not to receive care and services based on their individual patient care needs. Findings: a. During a review of Patient 1’s Patient Information Sheet (face sheet, admission record), the Patient Information Sheet indicated Patient 1’s Start of Care (SOC) date of 12/4/2024, with primary diagnosis of Pulmonary embolism without acute cor pulmonae (blood clots in the lungs without causing enlargement of the right side of the heart) During a review of Patient 1 ‘s medical record form titled Home Health Certification and Plan of Care (POC) for the certification period of 12/4/2024 to 2/1/2025, the POC indicated an order for frequency of visit from Skilled Nurses, two times a week for one week and three times a week for eight weeks. The POC indicated skilled nurse (SN) to assess wounds for changes every visit and measure wounds for depth, width and length weekly. During a concurrent interview and record review on 5/21/2025 at 2:54pm with Registered Nurse (RN) Clinical Director 3 (CD3), Patient 1’s visit calendar schedule for the month of December 2024 was reviewed. Patient 1’s visit calendar schedule for the month of December 2024 indicated the date of 12/9/2024 had a grey rectangle with the letters SN. CD3 stated a grey rectangle indicated that the home visit for that date was not done and stated the letters SN stood for skilled nurse. The grey rectangle for the date of 12/9/2024 on Patient 1’s visit schedule calendar further indicated a note by Registered Nurse 6 (RN6) indicating that the visit with Patient 1 was confirmed in advance and when RN6 arrived patient was not feeling well and visit was declined. CD3 stated and confirmed that the home visit for 12/9/2024 was not conducted. CD3 stated and confirmed that for the week of 12/8/2024 to 12/14/2024 there was no documentation that a home visit was offered or conducted for Patient 1. CD3 stated if a home visit is missed or declined the skilled nurses should attempt to reschedule the home visit that same week and document the outcome. CD3 stated for the week of 12/8/2024 to 12/14/2024 there were no nursing home visits conducted per physician orders of 2 times week. During a concurrent interview and record review on 5/21/2025 at 3:35 pm., with CD3, Patient 1’s clinical records titled Home Health/Hospice Nursing Assessment were reviewed. Patient 1’s Home Health/Hospice Nursing assessments dated 12/22/2024, 12/23/2024 and 12/24/2024 indicated documentation that the skilled nurses performed wound care and treatment for Patient 1’s wounds but did not have documented evidence of wound measurements completed for that week. CD3 stated and confirmed that for the week of 12/22/2024 when the Skilled Nurses performed home visits for Patient 1, the Home Health/Hospice Nursing Assessment’s dated 12/22/2024, 12/23/2024, and 12/24/2024 did not have documentation indicating that the wounds were measured. CD3 stated the HHA skilled nurses are to measure wounds weekly per policy. During a concurrent interview and record review on 5/22/2025 at 1:56 pm., with Registered Nurse 2 (RN2), Patient 1’s medical record titled Home Health/Hospice Nursing Assessment dated 12/23/2024 was reviewed. Patient 1’s clinical record indicated RN2 was the author of the assessment dated 12/23/2024. RN2 stated and confirmed she was the author of the nursing assessment dated 12/23/2024 and she performed wound care for Patient 1 as ordered by the physician. RN2 stated she is part of the wound care team for the HHA. RN2 stated patient’s wounds are to be photographed on admission, discovery, recertification, resumption of care, with any significant changes, on discharge, and are to be measured weekly. RN2 stated and confirmed she did not document wound measurements for Patient 1’s wounds on her home visit for 12/23/2024. During a concurrent interview and record review on 5/22/2025 at 2:06 pm., with the DPCS, Patient 1 ‘s medical records titled Home Health/Hospice Nursing Assessment dated 12/22/2024, 12/23/2024, and 12/24/2024 were reviewed. The DPCS stated per HHA policy, the skilled nurses are to assess wounds at every visit, photograph the wounds upon admission, recertification, resumption of care, discovery of wound and on discharge. The DPCS stated wounds are measured weekly. The DPCS stated and confirmed Patient 1’s Home Health/Hospice Nursing Assessment’s dated 12/22/2024, 12/23/2024, and 12/24/2024 did not include documentation of the wounds being measured for that week visit period. The DPCS stated it is important for patients with wounds to be assessed upon every visit and have weekly measurements so that the skilled nurses and care team have clinical oversight of the treatment and see if it is working for the patient, assess how well patient’s wounds are healing and be able to communicate this with the physician. The DPCS further stated the wound measurements are documented on the nursing assessment under the section skin/wound assessment. b. During a review of Patient 11’s Patient Information Sheet (face sheet, admission record), the Patient Information Sheet indicated Patient 11’s a start of care (SOC) date of 10/23/2024, with primary diagnosis of a Stage 4 (full thickness tissue loss with exposed bone, tendon, or muscle) pressure ulcer of the right hip (also tuberosity) and a Stage 4 pressure ulcer to the sacral (the large, triangular bone at the base of the spine) region. During a review of Patient 11 ‘s Home Health Certification and Plan of Care (POC) for the certification period from 4/21/2025 to 6/19/2025, the Home Health Certification and POC indicated to measure wounds for depth, width, and length weekly. During a concurrent observation and interview on 5/21/2025 at 10:30 a.m., in Patient 11’s bedroom, with RN 9, RN 9 performed wound care and treatment, but did not perform wound measurements. RN 9 stated that wound measurements were performed once a week. During a concurrent interview and record review on 5/21/2025 at 3:25 p.m., with the Registered Nurse Clinical Director (CD2), of Patient 11’s Nursing Routine Visit notes from 4/6/2025 through 5/12/2025, the Nursing Routine Visit notes did not indicate that wound measurements were performed weekly. The CD2 stated that there were no weekly wound measurements for Patient 11’s stage 4 pressure ulcer to the right ischial tuberosity (hip) for the weeks of 4/13/2025, 4/27/2025 and 5/4/2025 and stage 4 pressure ulcer to the sacrum for the weeks of 4/13/2025 and 5/4/2025. During an interview on 5/23/2025 at 11:23 a.m., with CD2, CD2 stated that Patient 11’s wounds should have been measured and documented weekly within the assessment. CD2 stated that it was important that the wound be measured weekly to show the progress or lack of progress of the wound healing, and if the wound treatment was not working, we would notify the physician for an updated plan of care for the wound care order which could include the wound care treatment, the materials or product used, or change the frequency of the visits for wound care. c. During a review of Patient 16’s “Patient Information” indicated a latest admit date of 6/4/2024, current certification period of 3/31/2025 to 5/29/2025, with a primary diagnosis of pressure ulcer (damage to the skin and underneath caused by prolonged pressure) of sacral region (or sacrum, is at the bottom of the spine and lies between the fifth segment of the lumbar spine (L5) and the coccyx (tailbone), it is a triangular-shaped bone and consists of five segments (S1-S5) that are fused together), stage 3 (a wound where the skin is broken all the way through, exposing the underlying fat tissue, appears like a crater with the fat visible at the bottom). During a review of Patient 16’ s “Home Health Certification and Plan of Care (POC, a detailed written document outlining the patient’s specific needs, including skilled nursing care, rehabilitative, and supportive care provided to a patient at home) for the certification period starting from 3/31/2025 to 5/29/2025, the POC included an order for the skilled nurse (SN) to: -Assess for signs and symptoms of infection Q (every) visit. -Assess signs and symptoms of peritoneal dialysis site problems to include: redness, swelling, pain, tenderness, bleeding every visit. -Measure wounds for depth, width, length weekly. During a concurrent observation and interview on 5/21/2025, at 10:12 a.m., with the Registered Nurse (RN4) and Clinical Director (CD), in Patient 16’s residence for a joint home visit, Patient 16 was comfortably resting in her bed, alert, awake and oriented to his name, time, place and events. Patient 16 has a caregiver (CG), she stated that she takes care of the patient 5 days a week, during daytime, and the patient’s family takes care of her (Patient 16) at nighttime. RN conducted hand hygiene, then performed an assessment of Patient 16’s wound of sacral region. RN stated that Patient 16’s wound of sacral region is categorized as stage 3 pressure ulcer. Patient 16’s wound of sacral region has no active bleeding, no yellow discharge and no foul odor. RN stated that visiting nurses measure the wound by depth, width, and length, of sacral region every week per POC order. RN stated that she did not measure Patient 16’s wound of sacral region during visit since the visiting nurse measured it on last Monday’s visit (5/19/2025). RN stated that nursing teams visit Patient 16 three times a week for wound care. RN performed wound care to Patient 16’s pressure ulcer of sacral region with the current treatment order, Patient 16 tolerated it well and has no complaint of pain. Patient 16 was observed with clean, dry and non-saturated dressing on her right lower abdominal area. RN stated that it is Patient 16’s peritoneal dialysis access. RN stated that Patient 16 had peritoneal dialysis access to her right lower abdomen since she was admitted to HHA services. RN stated that she has dialysis treatment (a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly) three times a week from an outpatient dialysis center and her (Patient 16) most recent dialysis treatment was yesterday (5/20/2025), CG confirmed it. RN stated that she does a visual assessment of peritoneal dialysis access on each visit. RN stated that she assesses for any signs and symptoms of infection like pain, redness, unusual discharges from Patient 16’s peritoneal dialysis access on her each visit. RN stated that the dialysis center nurse manages the dressing of it. During a concurrent interview and record review on 5/23/2025 at 11:35 a.m. with the CD of Patient 16’s electronic medical records, titled “SN (Skilled Nursing) Routine Visit,” dated week of 4/13/2025 to 4/19/2025 and week of 4/20/2025 to 4/26/2025, CD confirmed and stated that there is no documented evidence of Patient 16’s pressure ulcer of sacral region measurement by depth, width, and length. CD stated it is important to measure patient’s wounds as part of the assessment to compare previous and current measurements to determine the progression, improvement or worsening of the wound. CD stated that it is important to measure the wound as it is specified in patients’ POC as part of reassessment. During a concurrent interview and record review on 5/23/2025 at 11:35 a.m. with the CD of Patient 16’s electronic medical records, titled “SN (Skilled Nursing) Routine Visit,” dated 5/4/2025, 5/7/2025, 5/14/2025, 5/17/2025, and 5/18/2025, CD confirmed and stated that there is no documented evidence of Patient 16’s peritoneal dialysis access assessment as per POC indicated to assess signs and symptoms of peritoneal dialysis site problems to include: redness, swelling, pain, tenderness, bleeding every visit. CD stated it is important to follow the POC to assess Patient 16’s peritoneal dialysis access to determine the site’s appearance and to ensure that there are no signs and symptoms of infection. d. During a review of Patient 17’s “Patient Information” indicated a latest admit date of 4/25/2025, current certification period of 4/25/2025 to 6/23/2025, with a primary diagnosis of non-pressure chronic ulcer (a long-lasting open sore or wound that does not heal properly and is not caused by sustained pressure or friction) of right calf (muscle at the back of lower leg) with fat layer exposed. During a review of Patient 17’ s “Home Health Certification and Plan of Care (POC, a detailed written document outlining the patient’s specific needs, including skilled nursing care, rehabilitative, and supportive care provided to a patient at home) for the certification period starting from 4/25/2025 to 6/23/2025, the POC included an order for the skilled nurse (SN) to: -SN to cleanse the right posterior (back) calf diabetic ulcer (wound that is slow to heal, and is a complication of diabetes (disease which presents uncontrolled blood sugar level)) with Vashe (a wound cleanser), pat dry, apply medihoney (ointment or cream that treats local wound bed infection or reducing increased bacteria levels) to the wound bed, cover with a sterile 4 x 4 gauze and reinforce with Turbigrip (elastic and pressure bandage) D 3 x a week for 60 days. -Measure wounds for depth, width, length weekly. During a concurrent interview and record review on 5/23/2025 at 11:55 a.m. with the CD of Patient 17’s electronic medical records, titled “SN (Skilled Nursing) Routine Visit,” dated week of 4/27/2025 to 5/3/2025, CD confirmed and stated that there is no documented evidence of Patient 17’s right posterior calf diabetic ulcer’s measurement by depth, width, and length. CD stated it is important to measure patient’s wounds as part of the assessment to compare previous and current measurements to determine the progression, improvement or worsening of the wound. The CD stated that it is important to measure the wound as it is specified in patients’ POC as part of reassessment and to determine if current treatment is effective or need to be changed. During a review of the facility’s policy and procedure (P&P), titled “Skin Care: Prevention, Treatment, Photograph, and Measuring of Wounds, Pressure Ulcers, and Other Skin conditions,” dated 4/4/2025, the P&P indicated there will be individualized patient care focused specifically on personal hygiene of the skin with evaluation of the individual patient’s risk for skin injury. The P&P shall include basic procedures as defined in this policy for initiation and carrying out of preventive and early interventions. The P&P indicated that assessment of abnormal skin findings will be performed at every visit and dressing change, as appropriate, and documented in the electronic medical record (EMR). The P&P indicated documentation will include the following: 1. Location and/or stage of pressure injury 2. Weekly measurement of wound(s) length x width x depth and extent of undermining and tunneling (if present), using centimeters 3. Color of wound bed 4. Condition of periwound skin 5. Wound edges 6. Presence/absence of exudate and odor 7. Presence of granulation tissue and/or epithelialization During a review of the facility’s policy and procedure (P&P), titled “Care Planning,” dated 5/1/2021, the P&P indicated to ensure that the care and services provided to a patient are appropriate to each patient’s needs. The P&P indicated that the process of care planning will be documented on an on-going basis for all patients admitted to the HHA. The P&P indicated that: A. After initial patient evaluations are completed, the problems, interventions and outcome components will be documented in the electronic medical record (EMR). The medication profile will be available to view by staff. B. Care planning will be done on each patient as problems are identified. The following criteria may necessitate a review and revision to the Plan of Care. 1. Changes in the patient’s condition. 2. Changes in the patient’s psychosocial status. 3. Changes in the patient’s home environment. 4. Lack of achievement of outcomes within the specified time frame. 5. Changes in the patient’s response to care. 6. Changes that have occurred regarding diagnosis, prognosis, treatment including procedures, medication, equipment and limitations. C. Clinical staff will update the plan of care as problems are identified. The following information will be documented: 1. The date the problem(s) is identified 2. Statement of the problem(s) 3. lntervention(s) related to the problem(s) 4. Anticipated outcome(s) and resolution date(s) 5. A physician order for any changes in visit frequency D. The patient’s physician will be notified for changes in orders and physician orders will be written to include all pertinent information.”

“Written instructions to patient include: CFR(s): 484.60(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining: This Standard 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’s personal residence, rather than in a more traditional healthcare facility setting) failed to provide a copy of a recent, updated Plan of Care (POC- a document detailing a patient’s health needs, created by a healthcare team based on a comprehensive assessment of the patient’s condition and goals, outlining interventions and expected outcomes to be achieved) for four of seventeen sampled patients (Patient 2, Patient 3, Patient 16 and Patient 17). This deficient practice had the potential to cause the patient and/or the family/caregiver to not be aware of their treatment plan, the services provided and be an active participant in their care planning process. Findings: a. During a review of Patient 2’s Patient information Sheet (face sheet, admission record), the Patient Information Sheet indicated Patient 2’s Start of Care (SOC) date of 5/10/2025, with a primary diagnosis of aftercare following joint replacement surgery. During a review of Patient 2 ‘s medical record form titled Home Health Certification and Plan of Care (POC) for the certification period of 5/10/2025 to 7/8/2025, the POC indicated an order for frequency of visit from Skilled Nurses, one time a week for one week and two times a week for two weeks. The POC also indicated that at every visit the Skilled Nurse (SN) is to review medication with the patient/caregiver, assess knowledge of the medications like its use, action and side effects, and instruct the patient/caregiver on medication compliance. During a joint home visit on 5/21/2025 at 11:31am., with Registered Nurse 10 (RN10) at Patient 2’s home, Patient 2 was observed sitting up on his recliner sofa, awake, alert and oriented to self, date, time, location and can communicate his needs. Patient 2 was also observed with a kerlix wrap (gauze bandage roll used in medical settings for wound care and dressing management) wrapped around his right lower leg and secured with tape. During a concurrent interview and record review on 5/21/2025 at 12:14 pm., with RN10 at Patient 2’s home, Patient 2’s HHA folder was reviewed. Patient 2’s HHA folder indicated there was no evidence of a copy of Patient 2’s Plan of Care (POC). RN10 stated and confirmed Patient 2’s HHA folder did not have a copy of his POC. RN10 stated the patients are not provided a copy of their POC, instead the skilled nurses verbally review and go over the POC with the patients and family. Patient 2 stated he did not have a copy of his POC from the HHA with him, all he was given was in the folder. b. During a review of Patient 3’s Patient Information Sheet, the Patient Information Sheet indicated Patient 3’s Start of Care (SOC) date of 5/4/2025, with a primary diagnosis of atherosclerotic heart disease of native coronary artery without angina pectoris (a condition where atherosclerosis [build up of plaque in the artery walls] occurs in the coronary arteries, which supply blood to the heart, without chest pain). During a review of Patient 3 ‘s medical record form titled Home Health Certification and Plan of Care (POC) for the certification period of 5/4/2025 to 7/2/2025, the POC indicated an order for frequency of visit from Skilled Nurses, every three days for 60 days. During a joint home visit on 5/22/2025 at 10:06 am., with Licensed Vocational Nurse 9 (LVN9) at Patient 3’s home, Patient 3 was observed up on his feet walking with a front wheeled walker, awake, alert and oriented to self, date, time and location and able to communicate his needs. Patient 3 was observed with ace bandage (a long stretchable cloth strip used to provide support and compression) intact, wrapped around his right lower leg and his left lower leg. During a concurrent interview and record review on 5/22/2025 at 11:25 am., with LVN9, Patient 3’s HHA folder was reviewed. Patient 3’s HHA folder indicated there was no evidence of a copy of Patient 3’s Plan of Care (POC). LVN9 stated and confirmed Patient 3’s HHA folder did not have a copy of his POC. LVN9 stated that the HHA patients are not provided with a copy of their POC. Patient 3 stated and confirmed he did not receive a copy of his POC. During an interview on 5/23/2025 at 11:44am with the Director of Patient Care Services (DPCS), the DPCS stated the HHA did not provide Patient 3 a copy of POC, it could be provided to them upon their request. The DPCS stated patients were provided with an updated copy of their medication list. c. During a review of Patient 16’s “Patient Information” indicated a latest admit date of 6/4/2024, current certification period of 3/31/2025 to 5/29/2025, with a primary diagnosis of pressure ulcer (damage to the skin and underneath caused by prolonged pressure) of sacral region (or sacrum, is at the bottom of the spine and lies between the fifth segment of the lumbar spine (L5) and the coccyx (tailbone), it is a triangular-shaped bone and consists of five segments (S1-S5) that are fused together), stage 3 (a wound where the skin is broken all the way through, exposing the underlying fat tissue, appears like a crater with the fat visible at the bottom). During a review of Patient 16’ s “Home Health Certification and Plan of Care (POC, a detailed written document outlining the patient’s specific needs, including skilled nursing care, rehabilitative, and supportive care provided to a patient at home) for the certification period starting from 3/31/2025 to 5/29/2025, the POC included an order for the skilled nurse (SN) to: -Assess for signs and symptoms of infection Q (every) visit. -Assess signs and symptoms of peritoneal dialysis site problems to include: redness, swelling, pain, tenderness, bleeding every visit. -Measure wounds for depth, width, length weekly. During a concurrent observation and interview on 5/21/2025, at 10:12 a.m., with the Registered Nurse (RN3) and Clinical Director (CD3), in Patient 16’s residence for a joint home visit, Patient 16 was comfortably resting in her bed, alert, awake and oriented to his name, time, place and events. Patient 16 has a caregiver (CG) and was taking care of Patient 16 five days a week, during daytime, and the family was taking care of her (Patient 16) at nighttime. RN3 was observed conducted hand hygiene, then performed an assessment of Patient 16’s wound of sacral region. RN3 stated Patient 16’s wound of sacral region would be categorized as stage 3 pressure ulcer. Patient 16’s wound of sacral region was observed and has no active bleeding, no yellow discharge and no foul odor. RN3 stated the visiting nurses (in general) would measure the wound by depth, width, and length, of sacral region every week per POC order. RN 3 stated that she did not measure Patient 16’s wound of sacral region during visit since the visiting nurse (unknown) measured the wound on last Monday’s visit (5/19/2025). RN3 stated nursing teams visit Patient 16 three times a week for wound care. RN3 performed wound care to Patient 16’s pressure ulcer of sacral region with the current treatment order, Patient 16 tolerated well and has no complaint of pain. Patient 16 was observed with clean, dry and non-saturated dressing on her right lower abdominal area. RN3 stated Patient 16’s dressing on her right lower abdominal area was peritoneal dialysis access. RN3 stated Patient 16 had peritoneal dialysis access to her right lower abdomen since she was admitted to HHA services. RN3 stated Patient 16 has dialysis treatment (a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly) three times a week from an outpatient dialysis center and her (Patient 16) most recent dialysis treatment was yesterday (5/20/2025). RN3 stated she (RN3) conducted a visual assessment of peritoneal dialysis access on each visit. RN3 stated she (RN3) assessed for any signs and symptoms of infection like pain, redness, unusual discharges from Patient 16’s peritoneal dialysis access on her each visit. RN3 stated the dialysis center nurse manages the dressing. During a concurrent interview and record review on 5/21/2025 at 10:55 am., of Patient 16’s “Home Health Folder (compilation of pertinent medical documents provided to patient for record and reference at home),” with RN3, RN 3 confirmed and stated that there was no POC copy provided and included in Patient 16’s home health folder. RN 3 stated that she has the copy of the most recent medication list and POC and would include to Patient 16’s home health folder. RN 3 stated that it would be important for patients (in general) and their caregivers to have copies of medication lists and POC for their reference and as part of their involvement in care. c. During a review of Patient 17’s “Patient Information” indicated a latest admit date of 4/25/2025, current certification period of 4/25/2025 to 6/23/2025, with a primary diagnosis of non-pressure chronic ulcer (a long-lasting open sore or wound that does not heal properly and is not caused by sustained pressure or friction) of right calf (muscle at the back of lower leg) with fat layer exposed. During a telephone interview on 5/22/2025, at 3:10 p.m., with Patient 17, Patient 17 confirmed and stated that she (Patient 17) did not have a copy of a POC in her home health folder. Patient 17 stated that she could not remember what was a POC and if the visiting nurses provide a copy for her. During interview with CD3 on 5/23/2025, at 12:15 p.m., CD3 stated that HHA does not provide a copy of POC to patients (in general) unless the patients/patients’ family or caregiver requested a copy of it. CD3 stated that patients and their family/caregivers should be involved in formulating an individualized care plan to address specific needs. During a review of the HHA’s policy and procedure, titled “Care Planning,” revised 5/1/2021, the policy and procedure indicated that G. The patient and/or caregiver will be involved in planning care with respect to the patient/caregiver’s wishes, desires, expectations, and goals of care.”

“Responsibilities of skilled professionals CFR(s): 484.75(b) Standard: Responsibilities of skilled professionals. Skilled professionals must assume responsibility for, but not be restricted to, the following: This Standard is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) nursing staff failed to ensure that physician was promptly alerted to relevant changes in the patient’s condition for one of seventeen sampled patients (Patient 1). This failure had resulted in Patient 1’s delayed care and hospitalization for further treatment. Findings: During a review of Patient 1’s medical record titled Patient Information dated 5/20/2025, indicated Patient 1 start of care (SOC) date was 12/4/2024, with a primary diagnosis of pulmonary embolism without acute cor pulmonale (blood clots in the lungs without causing enlargement of the right side of the heart), and secondary diagnosis of neuromuscular dysfunction of the bladder (condition where bladder control is impaired due to problems with nerves or muscles that control urination that can result in urgency, frequency or retention of urine). During a review of Patient 1’s medical record titled Home Health Certification and Plan of Care (POC) for the certification period of 12/4/2024 to 2/1/2025 indicated an order for frequency of visit from Skilled Nurses, two times a week for one week and three times a week for eight weeks. The POC indicated skilled nurse (SN) to assess temperature, pulse, respirations (TPR) and blood pressure every visit and report to medical doctor (MD) if temperature was greater than 100 degree F (°F, unit of measurement for temperature), pulse was less than 50 bpm or greater than 130 bpm, respirations were less than 8 or greater than 30, systolic blood pressure (SBP- the first number, it measures the pressure your blood is pushing against your artery walls when the heart beats) was less than 90 or greater than 150, and diastolic blood pressure (DBP- is the second number, it measures the pressure your blood is pushing against your artery walls while the heart muscle rests between beats), and educate the patient/caregiver on signs and symptoms which warrant calling the HHA and instruct the patient/caregiver to call the HHA first. During a review of Patient 1’s medical record titled Outcome and Assessment Information Set (OASIS- the initial evaluation conducted at the beginning of a patient’s healthcare services) start of care (SOC) dated 12/4/2024 indicated, Patient 1 was incontinent with bowel and bladder on a daily basis. During a review of Patient 1’s medical record titled Home Health/Hospice Nursing Assessment dated 12/7/2024 indicated RN 5, conducted a home visit to Patient 1 and documented Patient 1 had diarrhea (loose and watery stools during bowel movements) since Patient 1 was in the hospital and date of last bowel movement was 12/7/2025. RN 5 documented Patient 1’s FM 1 informed her (RN5) that she (FM 1) thought it was because of Patient 1’s medication Eliquis (blood thinner medication) or maybe the antibiotics (medication that fights bacterial infections) from the hospital. The Nursing Assessment indicated no physician contact required or made for that home visit. The Nursing Assessment did not have documentation the physician was notified about the diarrhea, treatment orders for the diarrhea, or instructions provided to the patient’s caregiver on the care or monitoring of the diarrhea. During a review of Patient 1’s medical record titled Home Health/Hospice Nursing Assessment, dated 12/20/2024, indicated RN 6 conducted a home visit on 12/202/2025, and documented Patient 1 date of last BM was 12/20/2024 and that Patient 1 complained of two (2) episodes of loose bowel movement (BM), and perineal care was provided during the visit. Patient 1’s Nursing Assessment indicated RN 6 documented no physician contact required or made for that home visit. Patient 1’s Nursing Assessment for 12/20/2024 did not include documentation Patient 1’s physician was notified about Patient 1’s episode of loose stools, or treatment orders for the loose stools. During a review of Patient 1’s medical record titled Communication Note, dated 12/20/2024, RN 6 who conducted the home visit for Patient 1 on the same day on 12/20/2024, documented that she (RN 6) reported Patient 1 had two loose stools to Licensed Vocational Nurse (LVN) 10 in the office, and that Patient 1’s caregiver stated Patient 1 was started on antibiotics the night before and that it was a possible cause for the loose BMs. The Communication note also indicated RN 6 provided education to the patient’s caregiver on the importance of monitoring Patient 1’s episode of loose BM, and any other new unusual manifestations. If loose BM do not resolve within one to two days or if unusual manifestations were noted, contact Patient 1’s physician or go to the nearest hospital. During a review of Patient 1’s medical record titled Home Health/Hospice Nursing Assessment dated 12/21/2024 indicated RN 7, conducted the home visit on 12/21/2024 and documented that Patient 1 had two loose stools that morning. The Nursing Assessment indicated no physician contact required or made for that home visit. Patient 1’s Nursing Assessment did not include documentation the physician was notified about the loose stools, treatment orders for the loose stools, or instructions provided to the patient’s caregiver on the care or monitoring of the loose stools. During a review of Patient 1’s medical record titled Home Health/Hospice Nursing Assessment dated 12/22/2024 indicated that RN 8, who conducted the home visit, documented under the section Gastrointestinal, that Patient 1 had loose stool and a Clostridioides difficile (C. diff- highly contagious bacterial infection that causes diarrhea and can lead to inflammation of the colon and can be life threatening) test was completed on 12/20/2024 per FM 1. The medical record also indicated under the section Care Coordination, that RN8 selected the option No physician contact required/made for that home visit. Patient 1’s Home Health/Hospice Nursing Assessment dated 12/22/2024 did not include documented evidence of the physician being notified about the loose stools, treatment orders for the loose stools, or instructions provided to the patient’s caregiver on the care or monitoring of the loose stools. During an interview on 5/21/2025 at 10:18 am with Patient 1’s Family 1 (FM 1), FM 1 stated she (FM 1) verbalized to the skilled nurses (in general) conducting all home visits on 12/7/2024 that Patient 1 was having loose stools, and the skilled nurses (SN, in general) did not address or provide interventions. FM 1 stated the SN (in general) would tell her the loose stools could be caused by the antibiotics Patient 1 had been taking. Patient 1’s FM 1 stated that since the SN (in general) were not addressing the loose stools, she had to contact Patient 1’s physician office to make an appointment for Patient 1 to be evaluated for the loose stools. FM 1 stated the physician office and HHA were under the same company and were dealing with a cybersecurity hack, provided Patient 1 with a teleconference appointment on 12/10/2024. FM 1 stated Patient 1’s physician gave her (FM1) verbal order on 12/10/2024 to collect a stool and urine sample from the patient and take it to the outpatient laboratory for evaluation. FM 1 stated she collected the stool sample from Patient 1 on 12/20/2024 and turned it in to the outpatient laboratory on 12/20/2024. FM 1 stated she (FM 1) and her sister waited on collecting and turning in the stool culture because they (FM 1 and her sister) believed that Patient 1’s loose stools were caused from the antibiotic’s and wanted to see if they resolved. During a review of Patient 1’s medical record under the section visits records and assessments and communication notes, Patient 1’s medical record did not have documented evidence for the monitoring of the episodes of loose stools Patient 1 was having since the first documented occurrence of 12/7/2024. During a concurrent interview and record review on 5/21/2025 at 2:50 pm., with RN Clinical Director 3 (CD3), Patient 1’s medical records, under section Visit records and assessments was reviewed. During review of Patient 1’s medical record titled Home Health/Hospice Nursing Assessment dated 12/7/2024 indicated documented evidence of Patient 1 having had diarrhea since in hospital and stated patient’s daughter thought it was because of use of Eliquis (medication used to prevent and treat blood clots) or maybe antibiotics from the hospital. CD3 stated the clinical record did not have documentation that the physician was notified of Patient 1 having diarrhea, or if orders were received for treatment of the diarrhea. During a concurrent interview and record review on 5/21/2025 at 3:24 pm., with CD3, Patient 1’s medical record was reviewed. During review of Patient 1’s clinical record titled Home Health/Hospice Nursing Assessment dated 12/20/2024 indicated documented evidence of Patient 1 having two episodes of loose stool during that home visit. CD3 stated and confirmed that the clinical record did not have documentation that the physician was notified, or orders were received for treatment of the loose stools. CD3 stated the author of the Home Health/Hospice Nursing assessment dated 12/20/2024 was RN 6, and RN 6 attached a communication note indicating she (RN 6) called the HHA and spoke with a licensed Vocational Nurse (LVN, unknown) about Patient 1’s loose stool and she (RN 6) provided education to Patient 1’s FM1 in regard to monitoring the loose stools. CD3 stated that during review of Patient1’s medical records titled Communication notes, there was no documentation of the information dated 12/20/2024 indicating an LVN (unknown) or any office staff received report about Patient 1’s loose stool and communicated it with the physician. During a concurrent interview and record review on 5/21/2025 at 3:30 pm., with CD3, Patient 1’s medical records was reviewed. During review of Patient 1’s clinical record titled Home Health/Hospice Nursing Assessment dated 12/21/2024 indicated documented evidence of Patient 1 having episode of two loose stools that morning. CD3 stated the author of Patient 1’s Home Health/Hospice Nursing Assessment dated 12/21/2024 was RN 8. CD3 stated and verified the clinical record did not have documentation that the physician was notified, or orders were received for treatment of the loose stools. During a concurrent interview and record review on 5/21/2025 at 3:41 pm., with CD3, Patient 1’s medical records was reviewed. During review of Patient 1’s clinical record titled Home Health/Hospice Nursing Assessment dated 12/22/2024 indicated documented evidence of Patient 1 having loose stool, C. diff test completed on 12/20/2024 per daughter. The medical record also indicated under the section medication review, documentation indicating Imodium AD (over the counter medication used to treat diarrhea) use, and to notify the medical doctor prior to use. CD3 stated the author of Patient 1’s Home Health/Hospice Nursing Assessment dated 12/22/2024 was RN 8. CD3 stated RN 8 had mentioned to her (CD3) the medication Imodium was not an order from the doctor, and Patient 1’s daughter had the medication at home. CD3 stated and confirmed that the medical record did not have documentation that the physician was notified, or orders were received for treatment of the loose stool. During a concurrent interview and record review on 5/21/2025 at 4:25 pm., with CD3, Patient 1’s Electronic Medical Record (EMR) was reviewed. CD3 stated and confirmed that Patient 1’s Plan of Care (POC) did not include a care plan for the documented episodes of loose stools. CD3 stated since the Skilled Nurses (in general) documented that Patient 1 had episodes of loose stools on 12/7/2024, 12/20/2024, 12/21/2024, and 12/22/2024 it should have been care planned since the first assessment dated 12/7/2024. During a concurrent interview and record review on 5/22/2025 at 2:10 pm., with the DPCS, Patient 1’s Home Health/Hospice Nursing Assessment were reviewed. The DPCS stated that the assessments did not have documentation that the Skilled Nurses notified the physician of the ongoing loose stools. The DPCS stated Patient 1’s medical record titled Home Health Nursing Assessments indicated the following: · On 12/20/2024 Patient 1 had loose bowel movement two times · On 12/21/2024 Patient 1 had loose bowel movement two times in the morning · On 12/22/2024 Patient 1 had loose bowel movement but did not indicate the frequency. During an interview on 5/22/2025 at 2:10 pm., with the DPCS, the DPCS stated that the HHA’s practice of reporting changes in a patient’s condition during working hours is that the Skilled Nurse is to contact the team’s Clinical Manager and report to them about the changes in patients’ condition and the Clinical Manger will report it to the physician. The DPCS stated when Patient 1 was admitted on 12/4/2024 to the HHA from the hospital, Patient 1 already have episodes of loose stool at that time notifying the physician was not warranted. The DPCS stated that Patient 1’s Home Health/Hospice Nursing assessment dated 12/20/2024 had an attached communication note that indicated RN 6 contacted LVN 10 at the HHA office to report Patient 1’s episodes of loose stools. The DPCS stated when the Skilled Nurses documented on 12/20/2024 the two episodes of loose stools, this time the episodes of loose stool warranted contacting Patient 1’s physician because the patient was already weeks into being under the HHA care and the loose stools episode were continuing. During a telephone interview on 5/23/2025 at 11:26 am., with the RN Clinical Manager 1 (CM1), CM1 stated she was the manager for the care team that was in charge of Patient 1’s care. The CM1 stated her (CM1) daily duties included overseeing the nursing staff team, reviewing orders and taking care of patient complaints. CM1 stated she did not recall receiving report from any of the Skilled Nurses about Patient 1 having an episode of loose stools during the time of her care with the HHA. CM1 stated during the time Patient 1 was under services with the HHA, she did not know of or receive a call from Patient 1’s daughters with complaints about the care being provided. During a concurrent interview and record review on 5/23/2025 at 11:37 pm., with the DPCS, Patient 1’s medical record titled Communication Notes were reviewed. Patient 1’s Communication Notes did not indicate documentation indicating an LVN or staff from Patient 1’s care team office received report on 12/20/2024 from RN 6 that Patient 1 had episodes of loose stools, or if it was reported to the physician. During an interview on 5/23/2025 at 11:37 pm., with the DPCS, the DPCS stated when skilled nurses report to the clinical managers of changes in patient’s condition it was called a hand-off report. The DPCS stated that in the month of December 2024 the HHA and company were going through a cyber security hack and the Electronic Medical Record (EMR) and phone systems were all down, meaning staff could not upload their documentation that allowed others in the team to view, and only designated red phones were available for emergency use. The DPCS stated the HHA at that time began paper charting, and because the skilled nurse’s documentation was not being uploaded on the EMR and shared amongst them, the hand-off aspect was not being transferred over. The DPCS for Patient 1’s home visits dated 12/20/2024, 12/21/2024, and 12/22/2024, Patient 1 did not have the same skilled visit nurse, each visit day was a different skilled nurse. During a review of the HHA’s P&P titled, Care Planning dated 7/22/2021 indicated, that the process of care planning will be documented on an on-going basis for all patients admitted to the HHA and a change in patient’s condition may necessitate a review or revision to the Plan of Care. The P&P also indicated the clinical staff will update the plan of care as problems are identified and document in the plan of care the date the problem was identified, a statement of the problem, interventions related to the problem, anticipated outcomes and a physician order if there is a change in visit frequency. The P&P further indicated that all clinicians who identify a new patient problem and were not working consecutive days must communicate changes to the clinician who will be visiting the patient. 2. During a review of a cell phone text message dated 12/24/2024 at 8:40 pm., between Patient 1’s FM1 and RN2, the text messages indicated Patient 1’s FM1 sent a text message to RN 2 and stated that Patient 1’s blood pressure was 72/53 mmHG and heart rate of 138 bpm and to please advise her. The text messages indicated RN2 responded back with a message that Patient 1 could be dehydrated (having lost a large amount of water from the body), and asked if Patient 1 was drinking enough, what was her urine output over 24 hours and if Patient 1 had any fever. Patient 1’s FM1 responded back via text message and stated urine output was 1400 milliliter (ml- unit of measurement) and Patient did not have a fever. RN2 then responded back via text messaging and asked how Patient 1 was feeling, was she hard to wake up or feeling weak. Patient 1’s FM1 then responded back via text messaging and stated that she and her sister gave Patient 1 tramadol (a strong pain-reducing medication) at 6 pm and 500 mg of Tylenol (an over-the-counter pain reliever and fever reducer medication), and Patient 1 was awake, and was being given fluids. Patient 1’s FM1 further stated Patient 1’s BP was 81/59 mmHg and heart rate of 133 bpm. RN2 then responded via text messaging and stated to Patient 1’s FM1 to elevate Patient 1’s legs above her heart and recheck the blood pressure in 30 minutes. Patient 1’s FM1 responded back via text messaging with a thumb’s up emoji (small digital image used to express an idea or emotion). During a review of the cell phone text messaging between Patient 1’s FM1 and RN2, indicated that on 12/24/024 at 10:09 pm., RN2 responded and asked what Patient 1’s blood pressure and heart rate was. During a review of a cell phone text message dated 12/25/2024 at 11:15 am., between Patient 1’s FM1 and RN2, it indicated, Patient 1’s FM1 sent a text message and stated that her sister called and informed her Patient 1’s blood pressure was 76/54 mmHg, heart rate was 97bpm, sugar 213 and Patient 1 had diarrhea all night and was throwing up. RN2 responded back via text messaging and stated Patient 1 needs to be taken to the Emergency Room (ER). Patient 1’s FM1 then responded back via text messaging and stated, she will take Patient 1 now and thanked RN2. During an interview on 5/21/2025 at 10:18 am., with Patient 1’s FM1, Patient 1’s FM1 that on 12/24/2024 at 8:40 pm., she sent a text message to RN 2 about Patient 1 having an episode of low blood pressure and a high heart rate and stated RN 2 provided instructions to assess urine output, assess level of consciousness and to elevate her legs and recheck the blood pressure after 30 minutes. FM1 stated she followed RN2’s instructions and her sister took over Patient 1’s care after. FM1 stated the next morning she checked in with her sister to see how Patient 1 was doing, and her sister told her Patient 1’s blood pressure was low again, she had diarrhea and was throwing up. Patient 1’s FM1 stated she then sent a text message to RN 2 giving her that information and RN2 advised her to take Patient 1 to the ER. Patient 1’s FM1 stated she informed her sister that RN2 stated to take her to the ER, and because Patient 1 was weak, and continued with diarrhea and vomiting they called 911, and Patient 1 was taken to the ER via ambulance. During an interview on 5/22/2025 at 1:49 pm., with RN2, RN2 stated she (RN2) received a text message from FM1 on 12/24/2024 at night time, that Patient 1 had a low blood pressure of 72/53 mmHG. RN2 stated she responded back via text message, and asked Patient 1’s CG questions regarding Patient 1’s fluid intake, urine output, if she had a fever and what her level of consciousness was. RN2 stated she instructed Patient 1’s caregiver to elevate Patient 1’s legs above the heart and re-check the blood pressure after 30 minutes. RN2 stated she fell asleep because it was nighttime and the following morning on 12/25/2024 she (RN2) reached out to Patient 1’s CG to ask how Patient 1 was doing. RN2 stated Patient 1’s CG told her (RN2) that she had not heard from her sister, who stayed overnight with Patient 1, and stated Patient 1’s CG said I guess no news was good news. RN2 stated later that same morning on 12/25/2025 she received a text message from Patient 1’s CG stating Patient 1’s blood pressure was low again, had diarrhea all night and was throwing up. RN2 stated she responded back via text message to Patient 1’s CG informing her to take Patient 1 to the ER. RN2 stated she did not notify the physician of Patient 1’s low blood pressure episode. During a concurrent interview and record review on 5/22/2025 at 1:53 pm., with RN2, Patient 1’s medical record was reviewed. RN2 stated and confirmed there was no documented evidence that she informed the physician of Patient 1’s low blood pressure of 72/53 and high heart rate of 138. RN2 stated she did communicate this information with one of her supervisors but could not remember the supervisors’ name. During an interview on 5/22/2025 at 3:30 pm., with the DPCS, the DPCS stated all HHA patients receive a contact sheet in the HHA folder with their care teams names and numbers to contact in the office for assistance or questions. The DPCS stated the answering machine will direct the patient to leave a message if it is not urgent and if it is an urgent matter to call 911 or go to the hospital. The DPCS stated the HHA protocol was to educate patients to use their contact list for communication and for skilled nurses not to provide their cell phone numbers to patients/family members. The DPCS further stated in circumstances where Skilled nurses do communicate with a patient/family member regarding a concern the nurse is to triage the situation, and if it is urgent and/or family are not satisfied then the appropriate thing to do is for the skilled nurse to direct them to the ER. During an interview on 5/23/2024 at 11:23 am., with the RN Clinical Manager 1 (CM1), the CM1 stated it was expected of all skilled nurses that if a family member reports to them that a patient has a change in condition like a blood pressure of 72/53 mmHg and heart rate of 138 bpm then the skilled nurse was to direct them to call 911 or take them to the nearest emergency room. CM1 stated she did not have recollection of RN2 informing her about Patient 1 having an episode of low blood pressure on 12/24/2024. CM1 stated all patients were provided with a form in their HHA folder that includes their team office staff names and numbers that they can contact with any questions or assistance needed, as well as after-hours number. CM1 stated when patients call the main office line, during work or after hours, and they get the voice mail there is an outgoing message that tells the caller if they are experiencing certain issues like with Intravenous (IV- the act of administering fluids or medications into a vein) they can contact the pharmacy, or it this is an emergency dial 911. CM1 stated that SN’s were instructed that if a patient/family member contact them for advice or information they should direct the patient/family member to call the office main number for further help. During an interview on 5/23/2024 at 11:37 am., with the DPCS, the DPCS stated that if a skilled nurse receives communication from a patient, especially with unstable vital signs (measurement of the basic functions of your body like body temperature, blood pressure, pulse and respiratory [breathing] rate), then the expectation would be to drive them towards going to the emergency department. The DPCS stated at any point if a skilled nurse communicates with a patient or family member regarding a patient’s change of condition they should document it on a communication note. During a review of the HHA’s Policy and Procedure (P&P) titled, Responsibility of the Home Health and Hospice Departments and Physician in the Provision of Medical Care dated 6/25/2021, indicated it is the responsibility of the Home Health department and the physician to collaborate on care being provided to patients referred for Home Health care. The P&P also indicated that the collaboration the Home health department and physician included clinical staff keeping the physician informed on the significant clinical findings during home visits via telephone calls, electronic documentation and/or written reports which may include the Plan of Care, orders, progress notes of patient’s condition and transfer and discharge summaries as appropriate, and the Home Health staff will give verbal reports to the physicians agent at his/her office if unable to speak with the physician, and be available for the physician as needed for follow-up.”

“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) failed to review and document all medication changes and update the medication profile with currently used medications for three of 17 sampled patients (Patient 2, Patient 6, and Patient 16). This deficient practice had the potential to put the patients at risk for medication errors and adverse drug reactions. Findings: a. During a review of Patient 2’s Patient information Sheet (face sheet, admission record), the Patient Information Sheet indicated a Start of Care (SOC) of 5/10/2025, with a primary diagnosis of aftercare following joint replacement surgery. During a review of Patient 2 ‘s clinical record form titled Home Health Certification and Plan of Care (POC) for the certification period of 5/10/2025 to 7/8/2025, the POC indicated an order for frequency of visit from Skilled Nurses, one time a week for one week and two times a week for two weeks. The POC also indicated that at every visit the Skilled Nurse (SN) is to review medication with the patient/caregiver, assess knowledge of the medications like its use, action and side effects, and instruct the patient/caregiver on medication compliance. During a review of Patient 2’s medication list dated 5/20/2025 indicated medication orders of: Lisinopril (medication for high blood pressure) 10 milligrams (mg- unit of measurement) 1 tablet daily by mouth Tylenol extra strength (an over-the-counter pain reliever and fever reducer medication) 500 mg 2 tablets every 8 hours as needed (PRN) by mouth for pain Oxybutynin Chloride Extended Release (ER) 24 hour (long-acting medication used to treat overactive bladder) 10 mg 1 tablet daily by mouth Famotidine 20 mg 1 tablet at bedtime by mouth for Gastroesophageal reflux disease (GERD- a chronic condition where stomach acid flows back into the esophagus, causing heartburn) Sennosides-Docusate Sodium (a combined stimulant laxative medication used to treat occasional constipation) 8.6-50 mg 2 tablets PRN by mouth for constipation Oxybutynin Chloride ER 24-hour 10 mg 1 tablet at bedtime by mouth for overactive bladder Oxycodone Hydrochloride (HCL) (opioid analgesic, a type of pain reliever prescribed to manage moderate to severe pain) 5 mg, 1-2 tablets every 4 hours PRN by mouth for moderate to severe pain Aspirin low dose (medication used to prevent blood clots and reduce the risk of heart events like heart attacks and strokes) 81 mg chewable 1 tablet twice a day by mouth to prevent blood clots Doxazosin Mesylate (medication used to treat Benign Prostatic Hyperplasia [BPH- a condition in which the prostate gland grows larger than normal and presses on the urethra {tube that carries urine from the bladder to the outside of the body} causing trouble with urination]) 4 mg 1 tablet at bedtime by mouth During a joint home visit on 5/21/2025 at 11:31am with Registered Nurse 10 (RN10) at Patient 2’s home, Patient 2 was observed sitting up on his recliner sofa, awake, alert and oriented to self, date, time, location and can communicate his needs. Patient 2 was also observed with a kerlix wrap (gauze bandage roll used in medical settings for wound care and dressing management) wrapped around his right lower leg and secured with tape. During a concurrent interview and record review on 5/21/2025 at 12:04pm with RN10 at Patient 2’s home, Patient 2’s medication list and medication bottles were reviewed. Upon review of Patient 2’s medication bottles, it was noted Patient 2 had a medication bottle for Atorvastatin (medication used to treat high cholesterol [condition where you have too much cholesterol {waxy, fatlike substance found in all cells in the body} in the blood]) 10 mg take 1 tablet at bedtime orally with an expiration date of 9/2026. RN10 stated she confirmed with Patient 2 that the medication Atorvastatin is a current medication the patient is taking. RN10 stated and confirmed Patient 2’s medication bottle of Atorvastatin was not listed on the patient’s medication list that was in his HHA folder. RN10 stated the medication should have been included in the medication list because it is an active medication for the patient. RN10 further stated she would update Patient 2’s medication list with a pen to include the medication Atorvastatin, and at next visit provide him with a printed, updated medication list. RN10 stated medication review is done during every home visit with the patient or family. During an interview on 5/23/2025 at 12:01pm with the Director of Patient Care Services (DPCS), the DPCS stated medication reconciliation (review) is to be done by the Skilled Nurses at every home visit. The DPCS also stated the importance of the skilled nurses reviewing the patient’s medication during every home visit is to make sure the patient is taking the right prescribed medication the correct way, and if there are any changes provide the patient with updated medication list. b. During a review of Patient 6’s face sheet (admission record), the face sheet indicated Patient 6 was admitted on 1/10/2025 with a diagnosis of encounter for fitting and adjustment of a urinary device (a urinary catheter, a flexible tube used to drain urine from the bladder). During a review of Patient 6’s Plan of Care, the Plan of Care indicated for skilled nurse visits once per week. The plan of care indicated to review medications with the patient/caregiver with each visit. During a review of Patient 6’s Medication Profile, the Medication profile indicated for the following medications: 1) Cholestyramine (medication used to lower high cholesterol), by mouth packet 4 grams, take one three times per day via G-tube, (gastrostomy tube, a surgically placed device used to give direct access to the stomach for supplemental feeding, hydration or medicine). 2) Loperamide hydrochloride (medication used to treat diarrhea [loose, watery stools that occur more frequently than usual]) by mouth tablet 2mg 1 tablet daily via G-tube. 3) Tiger Balm Red (a topical ointment primarily used for pain relief, particularly for muscle and joint pain) extra strength, external ointment, one application PRN external (pertaining to outside of body). During an observation on 5/21/2025 at 10 a.m., at Patient 6’s residence, with RN 1 and Patient 6’ family member (FM) 2, a review of Patient 6’s medications was performed. During an interview and record review, on 5/21/2025 at 10:30 a.m., with FM 2 and RN1, Patient 6’s medication profile and medications on hand were reviewed. The following medications on hand: furosemide (a medication used to treat fluid retention [edema] and swelling) 20mg, PRN, 1 tab, in AM (in the morning) and Eliquis (an anticoagulant, which is a type of medicine that helps prevent blood clots from forming) 2.5 mg, 1 tab, daily, were not indicated on the medication profile. FM 2 stated Patient 6 had been taking the furosemide and Eliquis for close to a year. FM 2 stated that Patient 6 had not taken cholestyramine, loperamide hydrochloride, or tiger balm red ointment for a few months. During an interview on 5/21/2025 at 10:50 a.m., with RN 1 and CD 1, RN1 and CD 1 stated that the medication reconciliation should be done for their patients with each visit. RN 1 and CD 1 stated that it was important that medication reconciliation be done each visit so the patient will only take medications that the physician wants patient to currently have. When asked if the medication reconciliation was performed for Patient 6, RN 1 and CD 1 stated it should have been done after each visit but was clearly not done. c. During a review of Patient 16’s “Patient Information” indicated a latest admit date of 6/4/2024, current certification period of 3/31/2025 to 5/29/2025, with a primary diagnosis of pressure ulcer (damage to the skin and underneath caused by prolonged pressure) of sacral region (or sacrum, is at the bottom of the spine and lies between the fifth segment of the lumbar spine (L5) and the coccyx (tailbone), it is a triangular-shaped bone and consists of five segments (S1-S5) that are fused together), stage 3 (a wound where the skin is broken all the way through, exposing the underlying fat tissue, appears like a crater with the fat visible at the bottom). During a concurrent observation and interview on 5/21/2025, at 10:12 a.m., with the Registered Nurse (RN4) and Clinical Director (CD) 3, in Patient 16’s residence for a joint home visit, Patient 16 was comfortably resting in her bed, alert, awake and oriented to his name, time, place and events. Patient 16 has a caregiver (CG), she stated that she takes care of the patient 5 days a week, during daytime. During a reconciliation review of Patient 16’s medications with RN, the following medications were listed in Patient 16’s “medication list” but were not available: -Miralax by mouth powder 17 GM (gram, unit of weight)/scoop, 17 gram daily and as needed by mouth special instructions: constipation (A condition in which stool becomes hard, dry, and difficult to pass, and bowel movements does not happen very often) with start date of 6/10/2024, actual end date was blank. RN confirmed and stated that this medication was not available, and it was discontinued already. CG stated that Patient 16 does not use this medication anymore and has no issue with constipation. -Gentamycin Sulfate external cream 0.1% 1 application daily external, special instructions: peritoneal (a membrane, a sheet of smooth tissue that lines your abdominopelvic (abdomen/pelvis) cavity and surrounds your abdominal organs, It pads and insulates organs, helps to hold in place and secretes a lubricating fluid to reduce friction when they rub against each other), with a start date of 6/10/2024 , actual end date was blank. RN confirmed and stated that this medication was not available, and it was discontinued already. CG stated that Patient 16 does not use this medication anymore. -Furosemide by mouth tablet 20 milligrams (mg, unit of weight), ½ (one-half) tablet daily by mouth, special instructions: diuretic (medication that help reduce fluid buildup in the body), with a start date of 8/19/2024, actual end date was blank. RN confirmed and stated that this medication was not available, and it was discontinued already. CG stated that Patient 16 does not use this medication anymore. -Tramadol by mouth tablet 50 mg, 1 tablet every 8 hours as needed by mouth, special instructions: pain, with a start date of 8/19/2024, actual end date was blank. RN confirmed and stated that this medication was not available, and it was discontinued already. CG stated that Patient 16 does not use this medication anymore. -Anti-diarrheal by mouth capsule 2 mg, 1 capsule as needed by mouth, special instructions: diarrhea (uncontrolled loose stools), 2 capsules after 1st stool, then 1 capsule after; no more than 4 capsules in 24 hours, with a start date of 8/28/2024, actual end date was blank. RN confirmed and stated that this medication was not available, and it was discontinued already. CG stated that Patient 16 does not use this medication anymore. RN stated that she does Patient 16’s medications reconciliation on each visit. RN stated that discontinued medications were still listed in Patient 16’s active medication list and could be an electronic medical record glitch. RN stated that it is important that medication reconciliation is done on each visit to prevent confusion and mixed up of patients/caregivers of what medication to take and not. During an interview on 5/21/2025, at 11:11 a.m., with the Clinical Director (CD) 3, the CD 3 stated that nurses should conduct medication reconciliation on each visit and if patients have new medications or discontinued medications, nurses should coordinate with the agency or with the physician so it could also be updated to the current medication list and to avoid unnecessary discontinued medications and confusion among the healthcare team and patient. During a review of the HHA’s policy and procedure titled, “Patient Medication Profile,” revised date of 4/7/2023, the policy and procedure indicated a purpose to provide an ongoing medication update, including initiation of, changes in, or discontinuation of drugs, the policy indicated that each patient admitted to HHA shall have a medication profile in their electronic medical record (EMR) that is updated on an ongoing basis when there is medication change order, discontinuation order, or new medication order, the procedure indicated that: B. Any medication initiation, change, or discontinuation thereafter will be recorded on the EMR medication profile. C. Patient medications will be reviewed every visit. D. Any discontinued medications will be ended in the EMR medication profile.”

“At discharge CFR(s): 484.55(d)(3) At discharge. This Element is not met as evidenced by: Based on interview, and record review, the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to ensure a discharge assessment summary was completed and provided a copy of discharge notification and instructions to two of seventeen sampled patients (Patient 10 and Patient 14). This deficient practice resulted in the HHA without assessing and identifying the needs of patients/patients’ family and caregivers to ensure the provision of quality health care services when discharged from care and services. Findings: a. During a review of Patient 10’s Patient Information Sheet (face sheet, admission record), the Patient Information Sheet indicated Patient 10’s start of care (SOC) date of 4/6/2025, with a primary diagnosis of sepsis (serious condition in which the body responds improperly to an infection). The Patient Information Sheet indicated that on date 5/14/2025, Patient 10’s status was expired. During a concurrent interview and record review on 5/23/2025 at 1:20 p.m., with the Registered Nurse Clinical Director (CD) 2, Patient 10’s electronic medical record (EMR, an electronic collection of medical information about a patient that is stored on a computer) titled “Charts/Clinical Notes” dated 5/14/2025, was reviewed. The charts/clinical notes indicated that Patient 10 passed away early morning on 5/14/2025 and the physician’s office called LVN and LVN notified Clinical Manager (CM) 1. There was no discharge summary completed. CD 2 stated that Patient 10 did not have a discharge summary completed and that it should have been completed withing five days of the patient’s discharge. CD 2 stated that it was important that Patient 2’s discharge summary be completed so that the physician is aware of the patient’s discharge and the care that was provided during the time that the patient was on service with the HHA. b. During a review of Patient 14’s “Patient Information” indicated a latest admit date of 11/15/2024, and an end of care date (EOC) of 3/1/2025, with a primary diagnosis of non-pressure chronic ulcer (a long-lasting open sore or wound that does not heal properly and is not caused by sustained pressure or friction) of other part of left foot with unspecified severity. During a concurrent interview and record review on 5/23/2025, at 11:30 a.m., with the Clinical Director (CD) of Patient 14’s electronic medical record (EMR, an electronic collection of medical information about a patient that is stored on a computer) titled “ Charts/Clinical Notes” dated 3/1/2025, the charts/clinical notes indicated in the documentation that “Per SN (skilled nurse) patient passed away yesterday- pt’s (patient’s) dtr. (daughter) contacted her to notify.” Upon further concurrent review with the CD, there was no documented evidence that a discharge summary was completed. The CD confirmed and stated that no discharge summary was completed for Patient 14. The CD stated that the time frame to complete a discharge summary is within 48 hours and must be completed by the last clinician who seen the patient. The CD stated that a discharge summary must be completed even if the reason for patient’s discharge is death. The CD stated that it is important to complete a discharge summary for discharged patient since it is a regulation and not completing it will be against the HHA’s policy and procedure, and the discharge summary will include the reason of patient’s death. The CD stated that clinical managers oversee the discharge summary completion. During a review of the HHA’s policy and procedure titled, “Discharge from Home Health Services,” revised date of 8/13/2022, the policy and procedure indicated that patients may be discharged from the service for the following reasons: 12. The patient expires. E. Agency discharge summary will be written by the last professional discipline discharging the patient to facilitate a safe discharge with the copy provided to the physician within 5 days of the patient’s discharge.”

“Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient’s mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This Element is not met as evidenced by: Based on interview, and record review, the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to develop an individualized plan of care (POC, a document detailing a patient’s health needs, created by a healthcare team based on a comprehensive assessment of the patient’s condition and goals, outlining interventions and expected outcomes to be achieved) that includes management of potential problems, interventions, and goals for safety precautions while on anti-coagulant (blood thinner medication that can cause serious bleeding) medication for one of seventeen sampled patients (Patient 17). This deficient practice resulted in patient with no specific formulated POC for the current health status for management of symptoms that are likely to cause delayed care, undetected adverse signs and symptoms of medication. Findings: During a review of Patient 17’s “Patient Information” indicated a latest admit date of 4/25/2025, current certification period of 4/25/2025 to 6/23/2025, with a primary diagnosis of non-pressure chronic ulcer (a long-lasting open sore or wound that does not heal properly and is not caused by sustained pressure or friction) of right calf (muscle at the back of lower leg) with fat layer exposed. During a review of Patient 17’s clinical records titled, “Medication List,” the medication list includes the following: · Aspirin (A medication that reduces pain, fever, inflammation, and blood clotting) Adult low strength by mouth tablet chewable 81 milligrams (mg, unit of weight), 1 tablet daily by mouth. · Plavix (medication to prevent blood clots) by mouth tablet 75 mg, 1 tablet daily by mouth. During a telephone interview on 5/22/2025, at 3:10 p.m., with Patient 17, Patient 17 confirmed and stated that she currently taking both aspirin and Plavix medications with the same dosage and frequency as listed in her medication list. Patient 17 stated the visiting nurses did not provide any teachings regarding bleeding precautions while on aspirin and Plavix, what are the symptoms to look for and when to seek immediate medical care. During a concurrent interview and record review on 5/23/2025 at 11:55 a.m., with the Clinical Director (CD) 3 of Patient 17’s electronic medical records, titled “Home Health Certification and Plan of Care (POC, a detailed written document outlining the patient’s specific needs, including skilled nursing care, rehabilitative, and supportive care provided to a patient at home) for the certification period starting from 4/25/2025 to 6/23/2025, were reviewed. The CD3 confirmed and stated that the POC indicated bleeding precautions but no documented goals, interventions and expected outcomes. The CD3 stated that Plavix, an anti-coagulant and a high-risk medication, and a care plan must be formulated for patients that are currently taking the medication which includes bleeding precautions. The CD3 stated that a care plan for bleeding precautions should include goals, interventions, expected outcomes and patient/caregiver’s education of what symptoms to look for like gum bleeding, nose bleeding, blood in stool, urine, uncontrolled bleeding and unusual bruising and when to call for immediate medical care. The CD3 stated that visiting nurses (in general) should provide teachings and education to patient/patient’s caregivers regarding medications, its side effects and what to monitor for as specified in the POC. The CD3 stated that visiting nurses should reinforce patient teachings on each certification period to ensure that patient/patient’s caregiver understand it. The CD3 stated that visiting nurses should document the teachings and education provided to patient/patient’s caregiver to validate that it was done. During a review of the HHA’s policy and procedure titled, “Care Planning,” revised date of 5/1/2021, the policy and procedure indicated a purpose to ensure that the care and services provided are appropriate to each patient’s needs, and 9. At recertification, patient will be reassessed, this reassessment includes any changes or addition to care, treatments or services as follows which include: c. Medications and allergies, f. Safety precautions, g. Intervention, and h. Goals.”

“Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient’s condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This Element is not met as evidenced by: Based on 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 the physician was promptly alerted to relevant changes in the patient’s condition for one of seventeen sampled patients (Patient 1), when: Patient 1 had episodes of loose stools as indicated on visiting nursing notes dated 12/20/2024, 12/21/2024, and 12/22/2024. Patient 1’s Family Member (FM1) reported to Registered Nurse (RN) 2 that Patient 1 had low blood pressure (BP- force exerted by circulating blood against the artery walls and measured my millimeters mercury [mm Hg], normal range of BP is 90-120/ 60-90) and high heart rate (HR- number of times your heart beats per minute, normal heart rate is 60 beats per minute to 100 beats per minute), (BP 72/53 mm Hg Pulse 138 bpm) on 12/24/2024 at 8:40 p.m., subsequent BP and heart rate reading was 81/59 mmHg, heart rate 133 bpm. As a result, this deficient practice, of not notifying the physician of Patient 1’s Change of Condition (COC- any change in a person’s physical, mental, or behavioral state that is not the normal course of their daily routine or expected progress) of continuous episodes of loose stools for three (3) days on 12/20/2024, 12/21/2024, and 12/22/2024, and an episode of low blood pressure of 72/53 mmHg and heart rate of 138 bpm on 12/24/2024, resulted in the delay of care and treatment for Patient 1, which resulted in further decline of the patient’s condition requiring to call 911 (an emergency number that provides emergency assistance). Patient 1 required an emergency transfer via ambulance to General Acute Care Hospital (GACH1), Patient 1 was given fluid bolus (a rapid infusion of a relatively large volume of fluid, typically administered through an IV, to quickly restore fluid volume and address conditions like hypovolemia (low blood volume) or hypotension (low blood pressure). It’s often used in emergency situations or when immediate fluid replacement is needed.) and was admitted to GACH further treatment on 12/25/2024 and expired on 12/30/2024. On 5/23/2025 at 4:15pm, the 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) in the presence of the agency’s Director of Patient Care Services (DPCS) , Vice President of Regulatory Affairs, RN Clinical Directors, Director of Performance Outcomes, Vice President of Post-Acute Care, and Accreditation and Licensing Coordinator, related to the home health agency’s failure to ensure that physician was promptly alerted to relevant changes in the patient’s condition for one of seventeen sampled patients (Patient 1), when: 1. Patient 1 had episodes of loose stools as indicated on the visiting nursing notes dated 12/20/2024, 12/21/2024, 12/22/2024. 2. Patient 1’s Family Member (FM1) reported to RN 2 that Patient 1 had low blood pressure and high heart rate (BP 72/53 mmHg and Pulse 138 bpm), on 12/24/2024 at 8:40 p.m., subsequent BP and heart rate reading was 81/59 mmHg and heart rate 133 bpm. On 5/23/2025 at 4:30 PM, the HHA was unable to submit an IJ removal Plan (includes all actions the agency has taken or will take to immediately address the noncompliance that resulted in or made serious injury, serious harm, serious impairment, or death likely). On 5/23/2025 at 4:30 pm, the Department completed the survey tasks and conducted an exit conference while onsite in the presence of the DPCS, Vice President of Regulatory Affairs, RN Clinical Directors, Director of Performance Outcomes, Vice President of Post-Acute Care, and Accreditation and Licensing Coordinator, with the IJ not removed. Findings: 1. During a review of Patient 1’s medical record titled Patient Information dated 5/20/2025, indicated Patient 1 start of care (SOC) date was 12/4/2024, with a primary diagnosis of pulmonary embolism without acute cor pulmonale (blood clots in the lungs without causing enlargement of the right side of the heart), and secondary diagnosis of neuromuscular dysfunction of the bladder (condition where bladder control is impaired due to problems with nerves or muscles that control urination that can result in urgency, frequency or retention of urine). During a review of Patient 1’s clinical record titled Home Health Certification and Plan of Care (POC) for the certification period of 12/4/2024 to 2/1/2025 indicated an order for frequency of visit from Skilled Nurses, two times a week for one week and three times a week for eight weeks. The POC indicated skilled nurse (SN) to assess temperature, pulse, respirations (TPR) and blood pressure every visit and report to medical doctor (MD) if temperature was greater than 100 degree F (°F, unit of measurement for temperature), pulse was less than 50 bpm or greater than 130 bpm, respirations were less than 8 or greater than 30, systolic blood pressure (SBP- the first number, it measures the pressure your blood is pushing against your artery walls when the heart beats) was less than 90 or greater than 150, and diastolic blood pressure (DBP- is the second number, it measures the pressure your blood is pushing against your artery walls while the heart muscle rests between beats), and educate the patient/caregiver on signs and symptoms which warrant calling the HHA and instruct the patient/caregiver to call the HHA first. During a review of Patient 1’s clinical record titled Outcome and Assessment Information Set (OASIS- the initial evaluation conducted at the beginning of a patient’s healthcare services) start of care (SOC) dated 12/4/2024 indicated, Patient 1 was incontinent with bowel and bladder on a daily basis. During a review of Patient 1’s clinical record titled Home Health/Hospice Nursing Assessment dated 12/7/2024 indicated RN 5, conducted a home visit to Patient 1 and documented Patient 1 had diarrhea (loose and watery stools during bowel movements) since Patient 1 was in the hospital and date of last bowel movement was 12/7/2025. RN 5 documented Patient 1’s FM 1 informed her (RN5) that she (FM 1) thought it was because of Patient 1’s medication Eliquis (blood thinner medication) or maybe the antibiotics (medication that fights bacterial infections) from the hospital. The Nursing Assessment indicated no physician contact required or made for that home visit. The Nursing Assessment did not have documentation the physician was notified about the diarrhea, treatment orders for the diarrhea, or instructions provided to the patient’s caregiver on the care or monitoring of the diarrhea. During a review of Patient 1’s clinical record titled Home Health/Hospice Nursing Assessment, dated 12/20/2024, indicated RN 6 conducted a home visit on 12/202/2025, and documented Patient 1 date of last BM was 12/20/2024 and that Patient 1 complained of two (2) episodes of loose bowel movement (BM), and perineal care was provided during the visit. Patient 1’s Nursing Assessment indicated RN 6 documented no physician contact required or made for that home visit. Patient 1’s Nursing Assessment for 12/20/2024 did not include documentation Patient 1’s physician was notified about Patient 1’s episode of loose stools, or treatment orders for the loose stools. During a review of Patient 1’s clinical record titled Communication Note, dated 12/20/2024, RN 6 who conducted the home visit for Patient 1 on the same day on 12/20/2024, documented that she (RN 6) reported Patient 1 had two loose BM to Licensed Vocational Nurse (LVN) 10 in the office, and that Patient 1’s caregiver stated Patient 1 was started on antibiotics the night before and that it was a possible cause for the loose BMs. The Communication note also indicated RN 6 provided education to the patient’s caregiver on the importance of monitoring Patient 1’s episode of loose BM, and any other new unusual manifestations. If loose BM do not resolve within one to two days or if unusual manifestations were noted, contact Patient 1’s physician or go to the nearest hospital. During a review of Patient 1’s clinical record titled Home Health/Hospice Nursing Assessment dated 12/21/2024 indicated RN 7, conducted the home visit on 12/21/2024 and documented that Patient 1 had two loose stools that morning. The Nursing Assessment indicated no physician contact required or made for that home visit. Patient 1’s Nursing Assessment did not include documentation the physician was notified about the loose stools, treatment orders for the loose stools, or instructions provided to the patient’s caregiver on the care or monitoring of the loose stools. During a review of Patient 1’s clinical record titled Home Health/Hospice Nursing Assessment dated 12/22/2024 indicated that RN 8, who conducted the home visit, documented under the section Gastrointestinal, that Patient 1 had loose stool and a Clostridioides difficile (C. diff- highly contagious bacterial infection that causes diarrhea and can lead to inflammation of the colon and can be life threatening) test was completed on 12/20/2024 per FM 1. The medical record also indicated under the section Care Coordination, that RN8 selected the option No physician contact required/made for that home visit. Patient 1’s Home Health/Hospice Nursing Assessment dated 12/22/2024 did not include documented evidence of the physician being notified about the loose stools, treatment orders for the loose stools, or instructions provided to the patient’s caregiver on the care or monitoring of the loose stools. During an interview on 5/21/2025 at 10:18 am with Patient 1’s Caregiver, Patient 1’s Caregiver stated she verbalized to the skilled nurses (in general) conducting all home visits on 12/7/2024 that Patient 1 was having loose stools, and the skilled nurses (in general) did not address it or provide interventions. Patient 1’s FM 1 stated the SN would tell her the loose stools could be caused by the antibiotics Patient 1 had been taking. Patient 1’s FM 1 also stated that since the HHA SN were not addressing the loose stools, she had to contact Patient 1’s physician office to make an appointment for Patient 1 to be evaluated for the loose stools. Patient 1’s FM 1 stated the physician office and HHA were under the same company and were dealing with a cybersecurity hack, so they provided Patient 1 with a teleconference appointment on 12/10/2024. Patient 1’s FM 1 stated Patient 1’s physician gave her (FM1) verbal order on 12/10/2024 to collect a stool and urine sample from the patient and take it to the outpatient laboratory for evaluation. Patient 1’s FM 1 stated she collected the stool sample from Patient 1 on 12/20/2024 and turned it in to the outpatient laboratory on 12/20/2024. Patient 1’s FM 1 stated she and her sisters did wait on collecting and turning in the stool culture because they wanted to believe that Patient 1’s loose stools were caused from the antibiotic’s and wanted to see if they resolved. During a review of Patient 1’s medical record chart under the section visits records and assessments and communication notes, the medical record chart did not have documented evidence for the monitoring of the episodes of loose stools Patient 1 was having since the first documented occurrence of 12/7/2024. During a concurrent interview and record review on 5/21/2025 at 2:50 pm with RN Clinical Director 3 (CD3), Patient 1’s medical records chart, under section Visit records and assessments was reviewed. During review of Patient 1’s clinical record titled Home Health/Hospice Nursing Assessment dated 12/7/2024 indicated documented evidence of Patient 1 having had diarrhea since in hospital and stated patient’s daughter thought it was because of use of Eliquis (medication used to prevent and treat blood clots) or maybe antibiotics from the hospital. CD3 stated the clinical record did not have documentation that the physician was notified of Patient 1 having diarrhea, or if orders were received for treatment of the diarrhea. During a concurrent interview and record review on 5/21/2025 at 3:24 pm with CD3, Patient 1’s medical records chart was reviewed. During review of Patient 1’s clinical record titled Home Health/Hospice Nursing Assessment dated 12/20/2024 indicated documented evidence of Patient 1 having two episodes of loose stool during that home visit. CD3 stated and confirmed that the clinical record did not have documentation that the physician was notified, or orders were received for treatment of the loose stools. CD3 stated the author of the Home Health/Hospice Nursing assessment dated 12/20/2024 was RN 6, and further stated RN 6 attached a communication note indicating she called the HHA and spoke with a licensed Vocational Nurse (LVN) about Patient 1’s loose stool and that she (RN 6) provided education to Patient 1’s FM1 in regard to monitoring the loose stools. CD3 further stated that during review of Patient1’s medical records titled Communication notes, there was no documentation dated 12/20/2024 indicating the LVN or any office staff received report about Patient 1’s loose stool and communicated it with the physician. During a concurrent interview and record review on 5/21/2025 at 3:30 pm with CD3, Patient 1’s medical records chart was reviewed. During review of Patient 1’s clinical record titled Home Health/Hospice Nursing Assessment dated 12/21/2024 indicated documented evidence of Patient 1 having episode of two loose stools that morning. CD3 stated the author of Patient 1’s Home Health/Hospice Nursing Assessment dated 12/21/2024 was RN 8. CD3 stated and verified that the clinical record did not have documentation that the physician was notified, or orders were received for treatment of the loose stools. During a concurrent interview and record review on 5/21/2025 at 3:41pm with CD3, Patient 1’s medical records chart was reviewed. During review of Patient 1’s clinical record titled Home Health/Hospice Nursing Assessment dated 12/22/2024 indicated documented evidence of Patient 1 having loose stool, C. diff test completed on 12/20/2024 per daughter. The clinical record also indicated under the section medication review, documentation indicating Imodium AD (over the counter medication used to treat diarrhea) use, and to notify the medical doctor prior to use. CD3 stated the author of Patient 1’s Home Health/Hospice Nursing Assessment dated 12/22/2024 was RN 8. CD3 stated RN 8 had mentioned to her that the medication Imodium was not an order from the doctor, it was that the patient’s daughter had the medication at home and RN 7 educated the patient’s daughter to notify the physician if it was okay to give it to the patient while waiting for the stool culture results. CD3 stated and confirmed that the clinical record did not have documentation that the physician was notified, or orders were received for treatment of the loose stool from the HHA RN7. CD3 stated that while it was good practice of RN 7 to educate the patient’s daughter on contacting the physician before giving the patient a new medication, she (CD3) stated RN7 can also notify the physician of new medications. During a concurrent interview and record review on 5/21/2025 at 4:25 pm with CD3, Patient 1’s Electronic Medical Record (EMR) was reviewed. CD3 stated and confirmed that Patient 1’s Plan of Care (POC) did not include a care plan for the documented episodes of loose stools. CD3 stated since the Skilled Nurses (in general) documented that Patient 1 had episodes of loose stools on 12/7/2024, 12/20/2024, 12/21/2024, and 12/22/2024 it should have been care planned since the first assessment dated 12/7/2024. During a concurrent interview and record review on 5/22/2025 at 2:10 pm with the DPCS, Patient 1’s Home Health/Hospice Nursing Assessment were reviewed. The DPCS stated that the assessments did not have documentation that the Skilled Nurses notified the physician of the ongoing loose stools. The DPCS stated Patient 1’s medical record titled Home Health Nursing Assessments indicated the following: On 12/20/2024 Patient 1 had loose bowel movement two times On 12/21/2024 Patient 1 had loose bowel movement two times in the morning On 12/22/2024 Patient 1 had loose bowel movement but did not indicate the frequency. During an interview on 5/22/2025 at 2:10 pm, The DPCS stated that the HHA’s practice of reporting changes in a patient’s condition during working hours is that the Skilled Nurse is to contact the team’s Clinical Manager and report to them about the changes in patients’ condition and the Clinical Manger will report it to the physician. The DPCS stated when Patient 1 was admitted on 12/4/2024 to the HHA from the hospital, Patient 1 already have episodes of loose stool at that time notifying the physician was not warranted. The DPCS stated that Patient 1’s Home Health/Hospice Nursing assessment dated 12/20/2024 had an attached communication note that indicated RN 6 contacted LVN 10 at the HHA office to report Patient 1’s episodes of loose stools. The DPCS stated when the Skilled Nurses documented on 12/20/2024 the two episodes of loose stools, this time the episodes of loose stool warranted contacting Patient 1’s physician because the patient was already weeks into being under the HHA care and the loose stools episode were continuing. During a telephone interview on 5/23/2025 at 11:26 am with the RN Clinical Manager 1 (CM1), CM1 stated she was the manager for the care team that was in charge of Patient 1’s care. The CM1 stated her daily duties includes overseeing the nursing staff for her team, reviewing orders and taking care of patient complaints. CM1 stated she did not recall receiving report from any of the Skilled Nurses about Patient 1 having an episode of loose stools during the time of her care with the HHA. CM1 stated during the time Patient 1 was under services with the HHA, she did not know of or receive a call from Patient 1’s daughters with complaints about the care being provided. During a concurrent interview and record review on 5/23/2025 at 11:37 pm with the DPCS, Patient 1’s medical record titled Communication Notes were reviewed. Patient 1’s Communication Notes did not indicate documentation indicating an LVN or staff from Patient 1’s care team office received report on 12/20/2024 from RN 6 that Patient 1 had episodes of loose stools, or if it was reported to the physician. During an interview on 5/23/2025 at 11:37 pm, The DPCS stated when skilled nurses report to the clinical managers of changes in patient’s condition it was called a hand-off report. The DPCS stated that in the month of December 2024 the HHA and company were going through a cyber security hack and the Electronic Medical Record (EMR) and phone systems were all down, meaning staff could not upload their documentation that allowed others in the team to view, and only designated red phones were available for emergency use. The DPCS stated the HHA at that time began paper charting, and because the skilled nurse’s documentation was not being uploaded on the EMR and shared amongst them, the hand-off aspect was not being transferred over. The DPCS for Patient 1’s home visits dated 12/20/2024, 12/21/2024, and 12/22/2024, Patient 1 did not have the same skilled visit nurse, each visit day was a different skilled nurse. During a review of the HHA’s P&P titled, Care Planning dated 7/22/2021 indicated, that the process of care planning will be documented on an on-going basis for all patients admitted to the HHA and a change in patient’s condition may necessitate a review or revision to the Plan of Care. The P&P also indicated the clinical staff will update the plan of care as problems are identified and document in the plan of care the date the problem was identified, a statement of the problem, interventions related to the problem, anticipated outcomes and a physician order if there is a change in visit frequency. The P&P further indicated that all clinicians who identify a new patient problem and were not working consecutive days must communicate changes to the clinician who will be visiting the patient. 2. During a review of a cell phone text message dated 12/24/2024 at 8:40 pm between Patient 1’s FM1 and RN2, the text messages indicated Patient 1’s FM1 sent a text message to RN 2 and stated that Patient 1’s blood pressure was 72/53 mmHG and heart rate of 138 bpm and to please advise her. The text messages indicated RN2 responded back with a message that Patient 1 could be dehydrated (having lost a large amount of water from the body), and asked if Patient 1 was drinking enough, what was her urine output over 24 hours and if Patient 1 had any fever. Patient 1’s FM1 responded back via text message and stated urine output was 1400 milliliter (ml- unit of measurement) and Patient did not have a fever. RN2 then responded back via text messaging and asked how Patient 1 was feeling, was she hard to wake up or feeling weak. Patient 1’s FM1 then responded back via text messaging and stated that she and her sister gave Patient 1 tramadol (a strong pain-reducing medication) at 6 pm and 500 mg of Tylenol (an over-the-counter pain reliever and fever reducer medication), and Patient 1 was awake, and was being given fluids. Patient 1’s FM1 further stated Patient 1’s BP was 81/59 mmHg and heart rate of 133 bpm. RN2 then responded via text messaging and stated to Patient 1’s FM1 to elevate Patient 1’s legs above her heart and recheck the blood pressure in 30 minutes. Patient 1’s FM1 responded back via text messaging with a thumb’s up emoji (small digital image used to express an idea or emotion). During a review of the cell phone text messaging between Patient 1’s FM1 and RN2, indicated that on 12/24/024 at 10:09 pm RN2 responded and asked what Patient 1’s blood pressure and heart rate was. During a review of a cell phone text message dated 12/25/2024 at 11:15am between Patient 1’s FM1 and RN2, it indicated, Patient 1’s FM1 sent a text message and stated that her sister called and informed her Patient 1’s blood pressure was 76/54 mmHg, heart rate was 97bpm, sugar 213 and Patient 1 had diarrhea all night and was throwing up. RN2 responded back via text messaging and stated Patient 1 needs to be taken to the Emergency Room (ER). Patient 1’s FM1 then responded back via text messaging and stated, she will take Patient 1 now and thanked RN2. During a review of Patient 1’s medical records from GACH1 dated 12/25/2024, indicated Patient 1 was taken to GACH1 on 12/25/2024 at 12:05pm via Emergency Medical Services (EMS). The GACH1 record indicated upon arrival to GACH1 ER Patient 1 was tachycardic (fast heart rate), hypotensive (low blood pressure), and afebrile (without fever). Patient 1 presented with generalized weakness, vomiting and significant amount of diarrhea with abdominal pain after long course of antibiotics for lower extremity ulcers and there was a concern for hospital C.diff infection. The GACH record indicated a code Sepsis (a specific protocol or procedure implemented to quickly and effectively manage a patient experiencing sever sepsis [a life-threatening medical emergency that occurs when the body’s response to an infection causing a chain reaction throughout the body, potentially leading to tissue damage and organ failure]) was called and Patient 1 was given fluid bolus (a rapid infusion of a relatively large volume of fluid, typically administered through an IV, to quickly restore fluid volume and address conditions like hypovolemia (low blood volume) or hypotension. It’s often used in emergency situations or when immediate fluid replacement is needed.) During a review of Patient 1’s GACH1 Summary of Discharge Report, dated 12/25/2024 indicate Patient 1 Was positive with C.diff and suggestive of active C.diff infection (the bacteria are actively causing illness in the individual). During a re view of Patient 1’s GACH1 medical forms indicated Patient 1 was admitted to Definitive Observatory Unit (DOU- specialized unit where patients require more monitoring than a standard hospital room but do not need intensity of intensive care unit) on 12/25/2024, and on 12/27/2024 Patient 1 was transferred to Intensive Care Unit (ICU- specialized department providing intensive and specialized medical care to critically ill or injured patients who require continuous monitoring and life support) until 12/30/2024. During a review of Patient 1’s Certificate of Death, indicated Patient 1 date of death was 12/29/2024 at 8:37 PM with cause of death Cardiopulmonary arrest, urinary tract infection (an infection in the bladder/urinary tract), atherosclerotic heart disease (the buildup of fats, cholesterol and other substances in and on the artery walls ) and Alzheimer’s dementia (a general term describing the decline in mental abilities severe enough to interfere with daily life). Patient 1’s GACH1 medical forms dated 12/30/2024 at 12:27 am, indicated Patient 1 expired due to Cardiopulmonary arrest (sudden loss of all heart activity due to an irregular heart rhythm) with contributing factors that included septic shock (a severe and potentially life-threatening condition that occurs when sepsis, a systemic inflammatory response to infection, leads to critical circulatory, cellular, and metabolic dysfunction), catheter- associated urinary tract infection (an infection in the bladder/urinary tract caused by a hollow tube inserted into the bladder to drain or collect urine), colitis due to C.diff (inflammation of the lining of the colon caused by a highly contagious bacteria that causes severe diarrhea) , and myocardial infarction due to demand ischemia (MI- heart attack caused when the hearts oxygen demand is greater than the ability to supply, leading to temporary periods of inadequate blood flow). During an interview on 5/21/2025 at 10:18 am with Patient 1’s FM1, Patient 1’s FM1 that on 12/24/2024 at 8:40 pm she sent a text message to RN 2 about Patient 1 having an episode of low blood pressure and a high heart rate and stated RN 2 provided instructions to assess urine output, assess level of consciousness and to elevate her legs and recheck the blood pressure after 30 minutes. Patient 1’s FM1 stated she followed RN2’s instructions and her sister took over Patient 1’s care after. Patient 1’s FM1 stated the next morning she checked in with her sister to see how Patient 1 was doing, and her sister told her Patient 1’s blood pressure was low again, she had diarrhea and was throwing up. Patient 1’s FM1 stated she then sent a text message to RN 2 giving her that information and RN2 advised her to take Patient 1 to the ER. Patient 1’s FM1 stated she informed her sister that RN2 stated to take her to the ER, and because Patient 1 was weak, and continued with diarrhea and vomiting they called 911, and Patient 1 was taken to the ER via ambulance. During an interview on 5/22/2025 at 1:49 pm with RN2, RN2 stated she did receive a text message from Patient 1’s FM1 on 12/24/2024 at nighttime, informing her that Patient 1 had a low blood pressure of 72/53 mmHG. RN2 stated she responded back via text message, and asked Patient 1’s CG questions regarding Patient 1’s fluid intake, urine output, if she had a fever and what her level of consciousness was. RN2 stated she instructed Patient 1’s caregiver to elevate Patient 1’s legs above the heart and re-check the blood pressure after 30 minutes. RN2 stated she fell asleep because it was nighttime and the following morning on 12/25/2024 she (RN2) reached out to Patient 1’s CG to ask how Patient 1 was doing. RN2 stated Patient 1’s CG told her (RN2) that she had not heard from her sister, who stayed overnight with Patient 1, and stated Patient 1’s CG said I guess no news was good news. RN2 stated later that same morning on 12/25/2025 she received a text message from Patient 1’s CG stating Patient 1’s blood pressure was low again, had diarrhea all night and was throwing up. RN2 stated she responded back via text message to Patient 1’s CG informing her to take Patient 1 to the ER. RN2 stated she did not notify the physician of Patient 1’s low blood pressure episode. During a concurrent interview and record review on 5/22/2025 at 1:53pm with RN2, Patient 1’s medical record chart was reviewed. RN2 stated and confirmed there was no documented evidence that she informed the physician of Patient 1’s low blood pressure of 72/53 and high heart rate of 138. RN2 stated she did communicate this information with one of her supervisors but could not remember the supervisors’ name. During an interview on 5/22/2025 at 3:30pm with the DPCS, the DPCS stated all HHA patients receive a contact sheet in the HHA folder with their care teams names and numbers to contact in the office for assistance or questions. The DPCS stated the answering machine will direct the patient to leave a message if it is not urgent and if it is an urgent matter to call 911 or go to the hospital. The DPCS stated the HHA protocol is to educate patients to use their contact list for communication and for skilled nurses not to provide their cell phone numbers to patients/family members. The DPCS further stated in circumstances where Skilled nurses do communicate with a patient/family member regarding a concern the nurse is to triage the situation, and if it is urgent and/or family are not satisfied then the appropriate thing to do is for the skilled nurse to direct them to the ER. During an interview on 5/23/2024 at 11:23 am with the RN Clinical Manager 1 (CM1), the CM1 stated it is expected of all skilled nurses that if a family member reports to them that a patient has a change in condition like a blood pressure of 72/53 mmHg and heart rate of 138 bpm then the skilled nurse was to direct them to call 911 or take them to the nearest emergency room. CM1 stated she did not have recollection of RN2 informing her about Patient 1 having an episode of low blood pressure on 12/24/2024. CM1 further stated all patients were provided with a form in their HHA folder that includes their team office staff names and numbers that they can contact with any questions or assistance needed, as well as after-hours number. CM1 stated when patients call the main office line, during work or after hours, and they get the voice mail there is an outgoing message that tells the caller if they are experiencing certain issues like with Intravenous (IV- the act of administering fluids or medications into a vein) they can contact the pharmacy, or it this is an emergency dial 911. SN’s are instructed that if a patient/family member contact them for advice or information they should direct the patient/family member to call the office main number for further help. During an interview on 5/23/2024 at 11:37 am with the DPCS, the DPCS stated that if a skilled nurse receives communication from a patient, especially with unstable vital signs (measurement of the basic functions of your body like body temperature, blood pressure, pulse and respiratory [breathing] rate), then the expectation is to drive them towards going to the emergency department. The DPCS stated at any point if a skilled nurse communicates with a patient or family member regarding a patient’s change of condition they should document it on a communication note. During a review of the HHA’s Policy and Procedure (P&P) titled, Responsibility of the Home Health and Hospice Departments and Physician in the Provision of Medical Care dated 6/25/2021, indicated, It is the responsibility of the Home Health department and the physician to collaborate on care being provided to patients referred for Home Health care. The P&P also indicated that the collaboration the Home health department and physician included clinical staff keeping the physician informed on the significant clinical findings during home visits via telephone calls, electronic documentation and/or written reports which may include the Plan of Care, orders, progress notes of patient’s condition and transfer and discharge summaries as appropriate, and the Home Health staff will give verbal reports to the physicians agent at his/her office if unable to speak with the physician, and be available for the physician as needed for follow-up. During a review of the HHA’s P&P titled, Care Planning dated 7/22/2021 indicated, that the process of care planning will be documented on an on-going basis for all patients admitted to the HHA and a change in patient’s condition may necessitate a review or revision to the Plan of Care. The P&P also indicated the clinical staff will update the plan of care as problems are identified and document in the plan of care the date the problem was identified, a statement of the problem, interventions related to the problem, anticipated outcomes and a physician order if there is a change in visit frequency.”

“Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient’s updated comprehensive assessment, and contain information concerning the patient’s progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This Element is not met as evidenced by: Based on interview and record review the HHA failed to revise Plan of Care (POC- a document detailing a patient’s health needs, created by a healthcare team based on a comprehensive assessment of the patient’s condition and goals, outlining interventions and expected outcomes to be achieved) for one of seventeen sampled patients (Patient 1), to reflect Patient 1’s ongoing and monitoring of loose stools. This deficient practice had the potential to delay necessary interventions to achieve Patient 1’s goals and outcomes in resolving the loose stools, that could have caused a decline in her overall health. Findings: During a review of Patient 1’s Patient Information Sheet (face sheet, admission record), the Patient Information Sheet indicated Patient 1’s Start of Care (SOC) date of 12/4/2024, with primary diagnosis of Pulmonary embolism without acute cor pulmonae (blood clots in the lungs without causing enlargement of the right side of the heart) During a review of Patient 1 ‘s medical record form titled Home Health Certification and Plan of Care (POC) for the certification period of 12/4/2024 to 2/1/2025, the POC indicated an order for frequency of visit from Skilled Nurses, two times a week for one week and three times a week for eight weeks. The POC indicated skilled nurse (SN) to assess wounds for changes every visit and measure wounds for depth, width and length weekly. During a review of Patient 1’s medical record titled Outcome and Assessment Information Set (OASIS- the initial evaluation conducted at the beginning of a patient’s healthcare services) start of care (SOC) dated 12/4/2024 indicated, Patient 1 was incontinent with bowel and bladder on a daily basis. During a review of Patient 1’s medical record titled Home Health/Hospice Nursing Assessment dated 12/7/2024 indicated RN 5, conducted a home visit to Patient 1 and documented Patient 1 had diarrhea (loose and watery stools during bowel movements) since Patient 1 was in the hospital and date of last bowel movement was 12/7/2025. During a review of Patient 1’s medical record titled Home Health/Hospice Nursing Assessment, dated 12/20/2024, indicated RN 6 conducted a home visit on 12/202/2025, and documented Patient 1 date of last BM was 12/20/2024 and that Patient 1 complained of two (2) episodes of loose bowel movement (BM), and perineal care was provided during the visit. During a review of Patient 1’s medical record titled Home Health/Hospice Nursing Assessment dated 12/21/2024 indicated RN 7, conducted the home visit on 12/21/2024 and documented that Patient 1 had two loose stools that morning. During a review of Patient 1’s medical record titled Home Health/Hospice Nursing Assessment dated 12/22/2024 indicated that RN 8, who conducted the home visit, documented under the section Gastrointestinal, that Patient 1 had loose stool and a Clostridioides difficile (C. diff- highly contagious bacterial infection that causes diarrhea and can lead to inflammation of the colon and can be life threatening) test was completed on 12/20/2024 per FM 1. During a concurrent interview and record review on 5/21/2025 at 2:50 pm., with RN Clinical Director 3 (CD3), Patient 1’s medical record titled Home Health/Hospice Nursing Assessment dated 12/7/2024 was reviewed. CD3 stated and confirmed Registered Nurse 5 (RN5) documented that Patient 1 had diarrhea and was admitted to HHA with diarrhea. During a concurrent interview and record review on 5/21/2025 at 3:24 pm., with RN Clinical Director 3 (CD3), Patient 1’s medical record titled Home Health/Hospice Nursing Assessment dated 12/20/2024 was reviewed. CD3 stated and conformed RN6 documented Patient 6 had two episodes of loose stools that visit. During a concurrent interview and record review on 5/21/2025 at 3:30 pm with RN Clinical Director 3 (CD3), Patient 1’s medical record titled Home Health/Hospice Nursing Assessment dated 12/21/2024 was reviewed. CD3 stated and confirmed Registered Nurse 7 (RN7) documented Patient 1 had another 2 episodes of loose stools that morning. During a concurrent interview and record review on 5/21/2025 at 3:41 pm with RN Clinical Director 3 (CD3), Patient 1’s medical record titled Home Health/Hospice Nursing Assessment dated 12/22/2024 was reviewed. CD3 stated and confirmed Registered Nurse 8 (RN8) documented Patient 1 had episode of loose stool again. During a concurrent interview and record review on 5/21/2025 at 4:25 pm., with CD3, Patient 1’s Electronic Medical Record (EMR) was reviewed. CD3 stated and confirmed that Patient 1’s Plan of Care (POC) for the certification period of 12/4/2024 to 2/1/2025 did not have documentation of a care plan formulated for the documented episodes of loose stools, under the section Gastrointestinal. CD3 stated since the Skilled Nurses (in general) documented that Patient 1 had episodes of loose stools on 12/7/2024, 12/20/2024, 12/21/2024, and 12/22/2024 it should have been care planned since the first assessment finding on 12/7/2024 because it was an ongoing issue. CD3 further stated a POC is based on the nurses assessment form admission, it includes patient’s diagnosis, medications, medical equipment they use, safety concerns, diet, allergies, functional limitations, mental status, advance directive status, visit frequencies for each discipline and education for patient/caregiver. During an interview on 5/23/2025 at 11:44 am., with the Director of Patient Care Services (DPCS), the DPCS stated the POC was based on the nurses start of care assessment. The DPCS stated the POC determines what the patient’s care would be focused on based on and would be individualized based on the patient’s needs. The DPCS stated the POC would include specific education topics for the patient/family and the patient’s medications. The DPCS stated it would be important to update the POC because it would be the direction/guide of care that would be provided specific to each patient. The DPCS stated the POC that was not updated as needed would not allow the nurses to know what to focus on during visits and a patient’s care needs might not get addresses and be missed. During a review of the HHA’s Policy and Procedure (P&P) titled, Care Planning dated 7/22/2021 indicated, that the process of care planning will be documented on an on-going basis for all patients admitted to the HHA and a change in patient’s condition may necessitate a review or revision to the Plan of Care. The P&P also indicated the clinical staff will update the plan of care as problems are identified and document in the plan of care the date the problem was identified, a statement of the problem, interventions related to the problem, anticipated outcomes and a physician order if there is a change in visit frequency.”

“Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. 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, rather than in a more traditional healthcare facility setting) failed to ensure that education and training were provided to the patient/patient’s caregiver related to bleeding precautions while on anti-coagulant medication (medication that is used to prevent and treat blood clots in blood vessels and the heart) for one of seventeen sampled patients (Patient 17). This failure resulted in the patient’s/patient caregiver’s lack of understanding of possible risks, safety precautions, and side effects of medication. Findings: During a review of Patient 17’s “Patient Information” indicated a latest admit date of 4/25/2025, current certification period of 4/25/2025 to 6/23/2025, with a primary diagnosis of non-pressure chronic ulcer (a long-lasting open sore or wound that does not heal properly and is not caused by sustained pressure or friction) of right calf (muscle at the back of lower leg) with fat layer exposed. During a review of Patient 17’s medical records titled, “Medication List,” the medication list includes the following: • Aspirin (A medication that reduces pain, fever, inflammation, and blood clotting) Adult low strength by mouth tablet chewable 81 milligrams (mg, unit of weight), 1 tablet daily by mouth. • Plavix (medication to prevent blood clots) by mouth tablet 75 mg, 1 tablet daily by mouth. During a telephone interview on 5/22/2025, at 3:10 p.m., with Patient 17, Patient 17 confirmed and stated that she (Patient 17) would take both aspirin and Plavix medications with the same dosage and frequency as listed in her medication list. Patient 17 stated that she would take aspirin and Plavix medications to prevent from having blood clots. Patient 17 stated that the visiting nurses did not provide any teachings regarding bleeding precautions while on aspirin and plavix, what are the symptoms to look for and when to seek immediate medical care. During a concurrent interview and record review on 5/23/2025 at 11:55 a.m., with the Clinical Director (CD3) of Patient 17’s electronic medical records, titled “Home Health Certification and Plan of Care (POC, a detailed written document outlining the patient’s specific needs, including skilled nursing care, rehabilitative, and supportive care provided to a patient at home) for the certification period starting from 4/25/2025 to 6/23/2025, the CD confirmed and stated that the POC indicated bleeding precautions but no documented goals, interventions and expected outcomes. The CD stated Plavix is an anti-coagulant and a high-risk medication, stated that a care plan must be formulated for patients that are currently taking the medication which includes bleeding precautions. The CD stated that a care plan for bleeding precautions should include goals, interventions, expected outcomes and patient/caregiver’s education of what symptoms to look for like gum bleeding, nose bleeding, blood in stool, urine, uncontrolled bleeding and unusual bruising and when to call for immediate medical care. The CD stated that visiting nurses should provide teachings and education to patient/patient’s caregivers regarding medications, its side effects and what to monitor for as specified in the POC. The CD stated that visiting nurses should reinforce patient teachings on each certification period to ensure that patient/patient’s caregiver understand it. The CD stated that visiting nurses should document the teachings and education provided to patient/patient’s caregiver to validate that it was done. During a concurrent interview and record review on 5/23/2025 at 12:10 p.m., with the CD3 of Patient 17’s electronic medical records, titled “SN (Skilled Nursing) Routine Visit,” dated 4/28/2025, 5/2/2025, 5/5/2025, 5/9/2025, 5/12/2025, 5/14/2025, and 5/16/2025, CD3 confirmed and stated that there is no documented evidence of visiting nurses provided teachings related to bleeding precautions, what symptoms to look for while on anti-coagulation medications. CD stated it would be important for the clinical staffs to provide verbal teachings and written instructions to patients (in general) taking some medications that could potentially have side effects, like anti-coagulants. CD3 stated that written instructions provided to patients and their caregivers would help them of symptoms to look for and when to seek immediate care. During a review of the HHA’s policy and procedure, titled “Patient Education,” revised 8/13/2022, the policy and procedure indicated that B. The following instructions will be given to patients and their caregivers as appropriate, 2. Significant side effects, food interactions with nutritional counseling as needed, drug interactions and contraindications.”

“Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This Element is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to conduct a reassessment per patient’s plan of care (POC, a document detailing a patient’s health needs, created by a healthcare team based on a comprehensive assessment of the patient’s condition and goals, outlining interventions and expected outcomes to be achieved) for three of seventeen sampled patients (Patient 1, Patient 11, Patient 16, and Patient 17). For Patient 1, Patient 11, and Patient 17, the weekly wound measurement was not performed. For Patient 16, the daily peritoneal dialysis access (the method used to introduce a cleansing fluid [dialysate] into the abdominal cavity, where it can filter waste and excess fluid from the blood, it involves a soft tube surgically placed in the abdomen, through which the dialysate is infused and drained) assessment was not performed. This failure placed Patient 1, Patient 11, Patient 16, and Patient 17 delayed wound healing, decline and unmonitored progression or worsening condition that could result in hospitalization. Finding: a. During a review of Patient 1’s Patient Information Sheet (face sheet, admission record), the Patient Information Sheet indicated a Start of Care (SOC) of 12/4/2024, with primary diagnosis of Pulmonary embolism without acute cor pulmonae (blood clots in the lungs without causing enlargement of the right side of the heart) During a review of Patient 1 ‘s medical record form titled Home Health Certification and Plan of Care (POC) for the certification period of 12/4/2024 to 2/1/2025, the POC indicated an order for frequency of visit from Skilled Nurses, two times a week for one week and three times a week for eight weeks. The POC indicated skilled nurse (SN) to assess wounds for changes every visit and measure wounds for depth, width and length weekly. During a concurrent interview and record review on 5/21/2025 at 2:54 pm., with Registered Nurse (RN) Clinical Director 3 (CD3), Patient 1’s visit calendar schedule for the month of December 2024 was reviewed. Patient 1’s visit calendar schedule for the month of December 2024 indicated the date of 12/9/2024 had a grey rectangle with the letters SN. CD3 stated a grey rectangle indicated that the home visit for that date was not done and the letters SN stood for skilled nurse. CDs stated the grey rectangle for the date of 12/9/2024 on Patient 1’s visit schedule calendar indicated a note by Registered Nurse 6 (RN6) that the visit with Patient 1 was confirmed in advance and when RN6 arrived patient was not feeling well and visit was declined. CD3 stated and confirmed that the home visit for 12/9/2024 was not conducted. CD3 stated and confirmed that for the week of 12/8/2024 to 12/14/2024 there was no documentation that a home visit was offered or conducted for Patient 1. CD3 stated if a home visit is missed or declined the skilled nurses should attempt to reschedule the home visit that same week and document the outcome. CD3 stated for the week of 12/8/2024 to 12/14/2024 there were no nursing home visits conducted per physician orders of 2 times week. During a concurrent interview and record review on 5/21/2025 at 3:35 pm with CD3, CD3 stated, Patient 1’s medical records titled Home Health/Hospice Nursing Assessment were reviewed. Patient 1’s Home Health/Hospice Nursing assessments dated 12/22/2024, 12/23/2024 and 12/24/2024 indicated documentation that the skilled nurses performed wound care and treatment for Patient 1’s wounds but did not have documented evidence of wound measurements completed for that week. CD3 stated and confirmed that for the week of 12/22/2024 when the Skilled Nurses SN, in general) performed home visits for Patient 1, the Home Health/Hospice Nursing Assessment’s dated 12/22/2024, 12/23/2024, and 12/24/2024 did not have documentation indicating that the wounds were measured. CD3 stated the HHA skilled nurses (in general) has to measure wounds weekly per the agency’s policy. During a concurrent interview and record review on 5/22/2025 at 1:56 pm., with Registered Nurse 2 (RN2), Patient 1’s medical record titled Home Health/Hospice Nursing Assessment dated 12/23/2024 was reviewed. Patient 1’s clinical record indicated RN2 was the author of the assessment dated 12/23/2024. RN2 stated and confirmed she was the author of the nursing assessment dated 12/23/2024 and she performed wound care for Patient 1 as ordered by the physician. RN2 stated she (RN2) was in the wound care team for the HHA. RN2 stated patient’s (in general) wounds has to be photographed on admission, discovery, recertification, resumption of care, with any significant changes, on discharge, and are to be measured weekly. RN2 stated and confirmed she did not document wound measurements for Patient 1’s wounds on her home visit for 12/23/2024. During a concurrent interview and record review on 5/22/2025 at 2:06 pm., with the DPCS, Patient 1 ‘s clinical records titled Home Health/Hospice Nursing Assessment dated 12/22/2024, 12/23/2024, and 12/24/2024 were reviewed. The DPCS stated per HHA policy, the skilled nurses (in general) were to assess wounds at every visit, photograph the wounds upon admission, recertification, resumption of care, discovery of wound and on discharge. The DPCS stated wounds has to be measured weekly. The DPCS stated and confirmed Patient 1’s Home Health/Hospice Nursing Assessment’s dated 12/22/2024, 12/23/2024, and 12/24/2024 did not include documentation of the wounds being measured for that week visit period. The DPCS stated it would be important for patients (in general) with wounds to be assessed upon every visit and have weekly measurements so that the skilled nurses and care team have clinical oversight of the treatment and would be working for the patient, assessed how well patient’s wounds were healing and would communicate with the physician. The DPCS stated the wound measurements would be documented on the nursing assessment under the section skin/wound assessment. b. During a review of Patient 11’s Patient Information Sheet, the Patient Information Sheet indicated a start of care (SOC) of 10/23/2024, with primary diagnosis of a Stage 4 (full thickness tissue loss with exposed bone, tendon, or muscle) pressure ulcer of the right hip (also tuberosity) and a Stage 4 pressure ulcer to the sacral (the large, triangular bone at the base of the spine) region. During a review of Patient 11 ‘s Home Health Certification and Plan of Care (POC) for the certification period from 4/21/2025 to 6/19/2025, the Home Health Certification and POC indicated to measure wounds for depth, width, and length weekly. During a concurrent observation and interview on 5/21/2025 at 10:30 a.m., in Patient 11’s bedroom, with RN 9, RN 9 performed wound care and treatment, but did not perform wound measurements. RN 9 stated that wound measurements were performed once a week by the visiting skilled nurse. During a concurrent interview and record review on 5/21/2025 at 3:25 p.m., with the Registered Nurse Clinical Director (CD2), of Patient 11’s Nursing Routine Visit notes from 4/6/2025 through 5/12/2025, the Nursing Routine Visit notes did not indicate that visiting nurse performed wound measurements weekly. The CD2 stated that there were no weekly wound measurements for Patient 11’s stage 4 pressure ulcer to the right ischial tuberosity (hip) for the weeks of 4/13/2025, 4/27/2025 and 5/4/2025 and stage 4 pressure ulcer to the sacrum for the weeks of 4/13/2025 and 5/4/2025. During an interview on 5/23/2025 at 11:23 a.m., with CD2, CD2 stated that the visiting nurse measured Patient 11’s wounds and documented it weekly within the assessment. CD2 stated that it was important that the wound be measured weekly to show the progress or lack of progress of the wound healing, and if the wound treatment was not working, we would notify the physician for an updated plan of care for the wound care order which could include the wound care treatment, the materials or product used, or change the frequency of the visits for wound care. c. During a review of Patient 16’s “Patient Information” indicated a latest admit date of 6/4/2024, current certification period of 3/31/2025 to 5/29/2025, with a primary diagnosis of pressure ulcer (damage to the skin and underneath caused by prolonged pressure) of sacral region (or sacrum, is at the bottom of the spine and lies between the fifth segment of the lumbar spine (L5) and the coccyx (tailbone), it is a triangular-shaped bone and consists of five segments (S1-S5) that are fused together), stage 3 (a wound where the skin is broken all the way through, exposing the underlying fat tissue, appears like a crater with the fat visible at the bottom). During a review of Patient 16’ s “Home Health Certification and Plan of Care (POC, a detailed written document outlining the patient’s specific needs, including skilled nursing care, rehabilitative, and supportive care provided to a patient at home) for the certification period starting from 3/31/2025 to 5/29/2025, the POC included an order for the skilled nurse (SN) to: -Assess for signs and symptoms of infection Q (every) visit. -Assess signs and symptoms of peritoneal dialysis site problems to include: redness, swelling, pain, tenderness, bleeding every visit. -Measure wounds for depth, width, length weekly. During a concurrent observation and interview on 5/21/2025, at 10:12 a.m., with the Registered Nurse (RN3) and Clinical Director (CD3), in Patient 16’s residence for a joint home visit, Patient 16 was comfortably resting in her bed, alert, awake and oriented to his name, time, place and events. Patient 16 has a caregiver (CG), she stated that she takes care of the patient 5 days a week, during daytime, and the patient’s family takes care of her (Patient 16) at nighttime. RN3 conducted hand hygiene, then performed an assessment of Patient 16’s wound of sacral region. RN stated that Patient 16’s wound of sacral region is categorized as stage 3 pressure ulcer. Patient 16’s wound of sacral region has no active bleeding, no yellow discharge and no foul odor. RN3 stated that visiting nurses measure the wound by depth, width, and length, of sacral region every week per POC order. RN3 stated that she did not measure Patient 16’s wound of sacral region during visit since the visiting nurse measured it on last Monday’s visit (5/19/2025). RN3 stated that nursing teams visit Patient 16 three times a week for wound care. RN3 performed wound care to Patient 16’s pressure ulcer of sacral region with the current treatment order, Patient 16 tolerated it well and has no complaint of pain. Patient 16 was observed with clean, dry and non-saturated dressing on her right lower abdominal area. RN3 stated that it is Patient 16’s peritoneal dialysis access. RN3 stated that Patient 16 had peritoneal dialysis access to her right lower abdomen since she was admitted to HHA services. RN3 stated that she has dialysis treatment (a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly) three times a week from an outpatient dialysis center and her (Patient 16) most recent dialysis treatment was yesterday (5/20/2025), CG confirmed it. RN3 stated that she does a visual assessment of peritoneal dialysis access on each visit. RN3 stated that she assesses for any signs and symptoms of infection like pain, redness, unusual discharges from Patient 16’s peritoneal dialysis access on her each visit. RN3 stated that the dialysis center nurse manages the dressing of it. During a concurrent interview and record review on 5/23/2025 at 11:35 a.m. with the CD3 of Patient 16’s electronic medical records, titled “SN (Skilled Nursing) Routine Visit,” dated week of 4/13/2025 to 4/19/2025 and week of 4/20/2025 to 4/26/2025, CD3 confirmed and stated that there was no documented evidence of Patient 16’s pressure ulcer of sacral region measurement by depth, width, and length. CD3 stated it is important for the skilled visiting nurses to measure patient’s wounds as part of the assessment to compare previous and current measurements to determine the progression, improvement or worsening of the wound. CD3 stated that it would be important to measure the wound as it was specified in Patient 16’s POC as part of reassessment. During a concurrent interview and record review on 5/23/2025 at 11:35 a.m., with the CD3 of Patient 16’s electronic medical records, titled “SN (Skilled Nursing) Routine Visit,” dated 5/4/2025, 5/7/2025, 5/14/2025, 5/17/2025, and 5/18/2025, CD3 confirmed and stated that there was no documented evidence of Patient 16’s peritoneal dialysis access assessment as per POC indicated to assess signs and symptoms of peritoneal dialysis site problems to include: redness, swelling, pain, tenderness, bleeding every visit. CD3 stated it would be important for the skilled visiting nurses (in general) to follow the POC to assess Patient 16’s peritoneal dialysis access to determine the site’s appearance and to ensure that there are no signs and symptoms of infection. d. During a review of Patient 17’s “Patient Information” indicated a latest admit date of 4/25/2025, current certification period of 4/25/2025 to 6/23/2025, with a primary diagnosis of non-pressure chronic ulcer (a long-lasting open sore or wound that does not heal properly and is not caused by sustained pressure or friction) of right calf (muscle at the back of lower leg) with fat layer exposed. During a review of Patient 17’ s “Home Health Certification and Plan of Care (POC, a detailed written document outlining the patient’s specific needs, including skilled nursing care, rehabilitative, and supportive care provided to a patient at home) for the certification period starting from 4/25/2025 to 6/23/2025, the POC included an order for the skilled nurse (SN) to: -SN to cleanse the right posterior (back) calf diabetic ulcer (wound that is slow to heal, and is a complication of diabetes (disease which presents uncontrolled blood sugar level)) with Vashe (a wound cleanser), pat dry, apply medihoney (ointment or cream that treats local wound bed infection or reducing increased bacteria levels) to the wound bed, cover with a sterile 4 x 4 gauze and reinforce with Turbigrip (elastic and pressure bandage) D 3 x a week for 60 days. -Measure wounds for depth, width, length weekly. During a concurrent interview and record review on 5/23/2025 at 11:55 a.m. with the CD3 of Patient 17’s electronic medical records, titled “SN (Skilled Nursing) Routine Visit,” dated week of 4/27/2025 to 5/3/2025, CD3 confirmed and stated that there was no documented evidence of Patient 17’s right posterior calf diabetic ulcer’s measurement by depth, width, and length. CD3 stated it would be important for the skilled visiting nurses to measure Patient 17’s wounds as part of the assessment to compare previous and current measurements to determine the progression, improvement or worsening of the wound. The CD3 stated that it would be important to measure the wound as it was specified in Patient 17’s POC as part of reassessment and to determine if current treatment was effective or need to be changed. During a review of the facility’s policy and procedure (P&P), titled “Skin Care: Prevention, Treatment, Photograph, and Measuring of Wounds, Pressure Ulcers, and Other Skin conditions,” dated 4/4/2025, the P&P indicated there will be individualized patient care focused specifically on personal hygiene of the skin with evaluation of the individual patient’s risk for skin injury. The P&P shall include basic procedures as defined in this policy for initiation and carrying out of preventive and early interventions. The P&P indicated that assessment of abnormal skin findings will be performed at every visit and dressing change, as appropriate, and documented in the electronic medical record (EMR). The P&P indicated documentation will include the following: 1. Location and/or stage of pressure injury 2. Weekly measurement of wound(s) length x width x depth and extent of undermining and tunneling (if present), using centimeters 3. Color of wound bed 4. Condition of periwound skin 5. Wound edges 6. Presence/absence of exudate and odor 7. Presence of granulation tissue and/or epithelialization”

“Patient and caregiver education CFR(s): 484.75(b)(5) Patient and caregiver education; 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, rather than in a more traditional healthcare facility setting) nursing staff failed to ensure that education and training were provided to the patient/patient’s caregiver related to bleeding precautions while on anti-coagulant medication (medication that is used to prevent and treat blood clots in blood vessels and the heart) for one of seventeen sampled patients (Patient 17). This failure resulted in the patient’s/patient caregiver’s lack of understanding of possible risks, safety precautions, and side effects of anti-coagulant medication Findings: During a review of Patient 17’s “Patient Information” indicated a latest admit date of 4/25/2025, current certification period of 4/25/2025 to 6/23/2025, with a primary diagnosis of non-pressure chronic ulcer (a long-lasting open sore or wound that does not heal properly and is not caused by sustained pressure or friction) of right calf (muscle at the back of lower leg) with fat layer exposed. During a review of Patient 17’s medical records titled, “Medication List,” the medication list includes the following: · Aspirin (medication that reduces pain, fever, inflammation, and blood clotting) adult low strength by mouth tablet chewable 81 milligrams (mg, unit of weight), 1 tablet daily by mouth. · Plavix (medication to prevent blood clots) by mouth tablet 75 mg, 1 tablet daily by mouth. During a telephone interview on 5/22/2025, at 3:10 p.m., with Patient 17, Patient 17 confirmed and stated that she (Patient 17) was taking both aspirin and Plavix medications with the same dosage and frequency as listed in her medication list. Patient 17 stated that she (Patient 17) was taking aspirin and Plavix medications to prevent from having blood clots. Patient 17 stated the visiting nurses (in general) did not provide any teachings regarding bleeding precautions while on aspirin and Plavix, and symptoms to look for and when to seek immediate medical care. During a concurrent interview and record review on 5/23/2025 at 11:55 a.m., with the Clinical Director (CD3) of Patient 17’s electronic medical records, titled “Home Health Certification and Plan of Care (POC, a detailed written document outlining the patient’s specific needs, including skilled nursing care, rehabilitative, and supportive care provided to a patient at home) for the certification period starting from 4/25/2025 to 6/23/2025, the CD3 confirmed and stated the POC indicated bleeding precautions but no documented goals, interventions and expected outcomes. The CD3 stated Plavix is an anti-coagulant and a high-risk medication, and that a care plan must be formulated for patients (in general) that were currently taking the medication which includes bleeding precautions. The CD3 stated a care plan for bleeding precautions should include goals, interventions, expected outcomes and patient/caregiver’s education of what symptoms to look for like gum bleeding, nose bleeding, blood in stool, urine, uncontrolled bleeding and unusual bruising and when to call for immediate medical care. The CD3 stated that visiting nurses should provide teachings and education to patient/patient’s caregivers regarding medications, its side effects and what to monitor for as specified in the POC. The CD3 stated that visiting nurses should reinforce patient teachings on each certification period to ensure that patient/patient’s caregiver understand it. The CD3 stated that visiting nurses should document the teachings and education provided to patient/patient’s caregiver to validate that it was done. During a concurrent interview and record review on 5/23/2025 at 12:10 p.m., with the CD3 of Patient 17’s electronic medical records, titled “SN (Skilled Nursing) Routine Visit,” dated 4/28/2025, 5/2/2025, 5/5/2025, 5/9/2025, 5/12/2025, 5/14/2025, and 5/16/2025, the CD3 confirmed and stated that there was no documented evidence of visiting nurses provided teachings related to bleeding precautions, what symptoms to look for while on anti-coagulation medications. CD3 stated that it would be important for the clinical staffs to provide verbal teachings and written instructions to patients if they are taking some medications that could potentially have side effects, like anti-coagulants. CD3 stated that written instructions provided to patients and their caregivers will help them of symptoms to look for and when to seek immediate care. During a review of the HHA’s policy and procedure, titled “Patient Education,” revised 8/13/2022, the policy and procedure indicated that B. The following instructions will be given to patients and their caregivers as appropriate, 2. Significant side effects, food interactions with nutritional counseling as needed, drug interactions and contraindications.”