Community Home Care Services

“EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure 5 out of 5 annual Emergency Preparedness (EP) testing drills reviewed included all documentation including staff participation and event specific information regarding details of the exercise, resulting in the potential for an unprepared staff response during an emergency. Findings include: A review of agency policy titled “Testing Program for Emergency Operation Plan (EOP)” (revised January 2020) revlealed, “Exercises will review and confirm: Staff communication procedures and content; Assigned staff roles related to essential response functions…” The agency’s Emergency Preparedness (EP) information was reviewed on 5/15/25. During review of the agency’s testing exercises, it was determined the tabletop tornado drill (dated 3/19/25), actual blizzard emergency (dated 12/5/24), actual severe storm emergency (dated 6/25/24), actual blizzard emergency (dated 2/23/23), and actual blizzard emergency (dated 12/22/23) failed to include documentation of staff participation (who participated and how) and failed to include documentation of event specific information regarding what occurred during each exercise related to what was supposed to occur based on agency policy and procedure The Administrator (Adm-1) reviewed and acknowledged the findings listed above during an interview on 5/16/25 at 10:04 AM.”

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure missed visits altering the plan of care frequency were communicated with the doctor per agency policy in 3 (Patient #2, 3, 4) of 10 records reviewed, resulting in the potential for unmet patient care needs and poor patient outcomes. Findings include: Patient #2 (P-2), a 68-year-old was admitted to agency on 7/10/24 with diagnoses including paralysis of left side following stroke; Emphysema (lung condition causing shortness of breath); and generalized arthritis. The medical record was reviewed on 5/15/25. During review it was noted that the patient was recertified for home health services on 11/7/24 and included orders for Physical Therapy (PT) one time per week for 9 weeks. PT made 6 visits in 9 weeks and missed 3 visits (between 11/7/24 and 1/2/25). There were no visits entered in the week beginning 11/24/24 and no documentation that an attempt was made to reschedule the visit within those 7 days. There were no visits for 2 weeks straight on the weeks beginning 12/17/24 and 12/24/24 and no documentation that attempts were made to reschedule the visits within those 14 days. The PT entered a “Missed Visit Note” for each of the 3 scheduled visits within those 3 weeks with no PT services. The Missed Visit Note was a form with prompts such as “Physician Notified”; “Case Manager Notified”, “Date of Notification” and “Additional Comments”. The note gave space for the clinician to write a response after the prompts. It was noted the PT entered the word “Fax” after the prompts of “Physician Notified” and “Case Manager Notified”. All 3 missed visit notes failed to include a fax number for the physician, a date of notification for either the physician or the clinical manager, and what the physician response/instruction was following notification. This finding was reviewed and acknowledged by the Administrator (Adm-1) during an interview on 5/16/25 at 10:50 a.m. A review of agency policy titled “Plan of Care – CMS #485 and Physician/Practitioners Orders” (revised April 2023) revealed, “…If the Agency misses a visit or a treatment or services as required by the plan of care, which results in any potential for clinical impact upon the patient, then the Agency must notify the responsible physician/practitioner of such missed treatment or service. The physician/practitioner decides whether the treatment or service may be skipped or whether additional intervention is required by the Agency due to the clinical impact on the patient.” Patient #3 (P-3): This 83-year-old patient was admitted to this home care agency on 3/20/25 with the diagnoses of surgical care after surgery on the genitourinary system (for kidney stones), urinary tract infection, cardiomyopathy, and type II diabetes mellitus. During record review on 5/14/25, it was determined a missed visit for physical therapy was documented on 5/8/25 as the patient “declined alternate staff” when his regular physical therapist was not available. According to the missed visit documentation, the physician was notified via fax, however, there was no documentation regarding the physician’s response per agency policy above. Patient #4(P-4): This 72-year-old patient was admitted to this home health agency on 2/21/25 with the diagnoses of malignant neoplasm of the brain and left lower leg deep vein thrombosis (blood clot). During record review on 5/15/25, it was determined a missed visit for physical therapy was documented on 3/24/25 as the patient “declined alternate staff” when his regular physical therapist was not available. According to the missed visit documentation, the physician was notified via fax, however, there was no documentation regarding the physician’s response per agency policy above. The Administrator (Adm-1) reviewed and acknowledged the findings listed above during an interview on 5/16/25 at 10:04 AM. A review of the agency policy: “Plan of Care – CMS #485 and Physician/Practitioner Orders” (Revised April 2023). The policy states, “4. The individualized plan of care must include the following: The frequency and duration of visits to be made. 20. Care and services provided will be provided according to physician/practitioner orders. Orders are current and updated. 30. The patient’s orders for treatments and services are the foundation of the plan of care. If the Agency misses a visit or a treatment or services as required by the plan of care, which results in any potential for clinical impact upon the patient, then the Agency must notify the responsible physician/practitioner of such missed treatment or service. The physician/practitioner decides whether the treatment or service may be skipped or whether additional intervention is required by the Agency due to the clinical impact on the patient.” Patient #9’s (P-9) Start of Care (SOC) was dated 4/11/25. The Plan of Care (POC) identified diagnoses of Right Buttock Pressure Ulcer Stage 2, Congestive Heart Failure and Chronic Kidney Disease. During record review on 5/15/25, it was noted that Physical Therapy (PT) completed an evaluation on 4/14/25 with the ordered frequency of 2w8 (2 times a week for 8 weeks), 1w1. The week of 4/27/25 to 5/3/25 (Week 4) the PT completed 1 of 2 scheduled visits on 5/2/25 with no documented evidence of completing the second visit. Additionally, the PT documented missed visits on 5/9/25 (Friday) and 5/12/25 (Monday) with no attempt to complete the frequency as ordered. For both missed visits, the PT documented, “Physician Notified: Fax. Case Manger Notified: Fax.” There was no documented evidence of the fax numbers used to communicate with the physician and their response per agency policy. Furthermore, the POC ordered Home Health Aide (HHA) at a frequency of 2w7 on 4/11/25. The week of 4/13/25 to 4/19/25 the HHA completed 0 of 2 scheduled visits with no documented evidence of missed visits. The HHA failed to complete the visits as ordered. The Administrator (ADM-1) reviewed and acknowledged the findings listed about in an interview on 5/16/25 at 12:40 pm.”

“Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This Standard is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure the home health aide followed accepted standards of practice in infection control according to agency policy in 1 (P-1) of 1 observation in which a joint survey home visit was conducted with a home health aide, potentially resulting in transmission of infectious disease to this patient or any of the agency’s 143 current patients that are receiving, or may request to receive home health aide services. Findings include: Agency policy titled “Standard Precautions”, revised April 2023, was reviewed on 5/16/25. On page 3., it stated “5. Perform hand hygiene after removing gloves.” Patient #1 (P-1), a 95-year-old was admitted to agency on 1/17/24 with diagnoses including Crohn’s disease (inflammatory bowel disease) and a suprapubic cystostomy (surgical opening of the urinary bladder to drain urine). On 5/14/25 a joint home visit was conducted with the home health aide (HHa) at 8 a.m. The HHa was scheduled to perform a shower with P-1 during the visit. Upon arrival, the HHa was observed performing hand hygiene after reaching her hand (dirty) into her shirt pocket to retrieve hand sanitizer. While preparing for the shower procedure, and after touching many household items, the HHa was observed reaching her hand (dirty) in her shirt pocket to retrieve a pair of gloves. The HHa was observed removing and discarding a dirty pair of gloves and reaching her hand (dirty) in her shirt pocket to retrieve another pair of gloves. The HHa did not perform hand hygiene after removing the dirty pair of gloves and putting on the new pair. After completing the showering tasks, the HHa removed/discarded the dirty gloves and then reached her hand (dirty) in her shirt pocket for the hand sanitizer. The HHa performed hand hygiene and then put the hand sanitizer back in her pocket. The findings were reviewed with the Administrator (Adm-1) during an interview on 5/16/25 at 10:50 a.m. Adm-1 was asked for a policy describing the procedure for when staff should place items for patient care in the pockets of their clothing. Adm-1 stated that although policy does not describe this practice, all staff are given a bag to hold/retrieve needed hand sanitizer and patient care supplies while at a patient’s home and are instructed on the use of the items/bag. Adm-1 stated that staff should not be placing patient care items in their clothing pockets and acknowledged the above findings.”

“Payment from federally funded programs CFR(s): 484.50(c)(7)(i, ii, iii, iv) Be advised, orally and in writing, of- (i) The extent to which payment for HHA services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (ii) The charges for services that may not be covered by Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (iii) The charges the individual may have to pay before care is initiated; and (iv) Any changes in the information provided in accordance with paragraph (c)(7) of this section when they occur. The HHA must advise the patient and representative (if any), of these changes as soon as possible, in advance of the next home health visit. The HHA must comply with the patient notice requirements at 42 CFR 411.408(d)(2) and 42 CFR 411.408(f). This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure that 2 (P-8, P-9) of 10 overall patient planning of care records reviewed included informing the patient/caregiver in advance of potential payment charges, resulting in a lack of inclusion in planning, lack of informed consent, and unmet care needs. Findings include: A review of the agency policy: “Patient Admission Criteria” (Revised February 2021). The policy states, “13. During the initial visit, the admitting professional will: Explain and provide a copy of the Patient’s Bill of Rights/Responsibilities, Privacy Notice and advance directives…” Patient #8’s (P-8) Start of Care (SOC) was dated 4/17/25. The Plan of Care (POC) identified diagnoses of Ureteral Calculus, Urinary Tract Infection and Acute Kidney Infection. During record review on 5/15/25, it was noted that the signed “Consent for Treatment” was blank under the sections “Charges, Insurance pays, I pay, Co-Payment, and Deductible”. The agency failed to notify the patient in advance of possible payments required. Patient #9’s (P-9) Start of Care (SOC) was dated 4/11/25. The Plan of Care (POC) identified diagnoses of Right Buttock Pressure Ulcer Stage 2, Congestive Heart Failure and Chronic Kidney Disease. During record review on 5/15/25, it was noted that the signed “Consent for Treatment” was blank under the sections “Charges, Insurance pays, I pay, Co-Payment, and Deductible”. The agency failed to notify the patient in advance of possible payments required. The Administrator (ADM-1) reviewed and acknowledged the findings listed about in an interview on 5/16/25 at 12:25 pm.”

“RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient’s return home, or on the physician or allowed practitioner - ordered start of care date. This Element is not met as evidenced by: Based on record review and interview, the agency failed to notify the physician/practitioner the initial assessment to determine immediate care needs and home care eligibility would not be performed within 48 hours of referral in 1 (Patient #3) of 10 records reviewed, resulting in the potential for unidentified patient care needs. Findings include: Review of agency policy titled “Initial Assessments/Comprehensive Assessments” (revised April 2023) indicated, “In instances where the patient requests a delay in the start of care date, the Agency will need to contact the physician/practitioner to request a change in the start of care date and such change will be documented in the medial record.” Patient #3 (P-3): This 83-year-old patient was admitted to this home care agency on 3/20/25 with the diagnoses of surgical care following surgery on the genitourinary system (for kidney stones), urinary tract infection, cardiomyopathy, and type II diabetes mellitus. During record review on 5/13/25, it was noted the referral to start home care services was dated 3/15/25. Upon further review of the record, it was determined the initial assessment did not occur until 3/20/25 – 5 days after the date of referral. During an interview with the Administrator (Adm-1) on 5/16/25 at 10:04 AM, Adm-1 was asked about the reason for the late start. Adm-1 indicated the summary sections on the Outcome Assessment and Information Set (OASIS) dated 3/20/25 indicated, “He discharged home on 3/14/25. Admission performed at date and time of patient choosing PCP aware of admission date.” [sic] However, Adm-1 confirmed this was documented on 3/20/25 (the date of the late initial assessment) and was unable to provide evidence of the physician being notified prior to the late start. Adm-1 acknowledged the findings at the time of interview.”

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment included identification of duplicate drug therapy for 3 (P-1, P-9, P-10) of 10 records reviewed resulting in the potential for an undetected harmful medication related poor outcome for this patient. Findings include: Agency policy titled “Medication Reconciliation”, revised February 2021, was reviewed on 5/16/25. On page 1., it stated “The Agency will reconcile patient medications at the time of admission and on an ongoing basis in order to identify any potential adverse effects and drug reactions… any concerns or discrepancies will be reconciled by a RN with the patient’s physician/practitioner. Discrepancies include duplications…”. P-2: This 68-year-old was admitted to agency on 7/10/24 with diagnoses including paralysis of the left side following stroke; Emphysema (lung condition causing shortness of breath); and generalized arthritis. The medical record was reviewed on 5/15/25. During review of the Comprehensive Assessment dated 7/10/24, it was noted that the registered nurse (RN) completing the assessment marked that “issues” were identified during the medication review. There was no documentation identifying what issues were identified with the medication review. It was noted that the patient was prescribed 3 Nonsteroidal Anti-inflammatory (NSAID) medications (Aspirin, Ibuprofen, and Aleve). Upon review of the drug interactions for this patient using the agency’s electronic medical record (EMR) system, the duplication of (NSAID) medications was not displayed. The drug-to-drug interactions list for this patient’s medications did display moderate interactions between 5 medications (including the NSAID’s). On 5/15/25 at 11:46 a.m., an interview was conducted with the Administrator (Adm-1). Adm-1 was asked if the agency EMR system identified duplicate drug therapies. After investigating the question, Adm-1 stated that the EMR system does not display duplications in drug therapy, and it was left to the admitting clinician to determine if duplications existed. There was no documented evidence in the Comprehensive Assessment or agency Medication Profile for this patient that the RN identified the duplication of drug therapy for the 3 NSAID medications prescribed. There was no evidence that the RN reviewed the NSAID’s as a duplicate drug therapy with the physician as agency policy requires. Adm-1 acknowledged this finding at the time that it was found. P-9: The Start of Care (SOC) was dated 4/11/25. The Plan of Care (POC) identified diagnoses of Right Buttock Pressure Ulcer Stage 2, Congestive Heart Failure and Chronic Kidney Disease. During record review on 5/15/25, section M2001 of the “Comprehensive Assessment” dated 4/11/25 and completed by the Registered Nurse (RN), documented “Issues found during review.” M2003 was marked “Yes” regarding “Medication Follow-up: Did the agency contact a physician by midnight of the next calendar day and complete prescribed/recommended actions in response to the identified potential clinically significant medication issues?” There was no documentation identifying what issues were identified with the medication review. Additionally, It was noted that the patient was prescribed 6 Cardiovascular agent medications (Amlodipine, Doxazosin, Furosemide, Lovastatin, Metoprolol Succinate and Spironolactone) and 3 Antihypertensive medications (Amlodipine, Doxazosin and Metoprolol Succinate). Review of the drug interactions within the agency’s Electronic Medical Record (EMR) system, the duplication of Cardiovascular agents and Antihypertensive medications was not displayed. There was no documented evidence in the Comprehensive Assessment or agency Medication Profile for this patient that the RN identified the duplication of drug therapy for the 6 Cardiovascular agent and 3 Antihypertensive medications prescribed. There was no evidence that the RN reviewed the duplicate drug therapy with the physician as agency policy requires. P-10: The Start of Care (SOC) was dated 11/18/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure and Diabetes Type 2. During record review on 5/13/25, section M2001 of the “Comprehensive Assessment” dated 11/18/24 and completed by the RN, documented “Issues found during review.” M2003 was marked “Yes” regarding “Medication Follow-up: Did the agency contact a physician by midnight of the next calendar day and complete prescribed/recommended actions in response to the identified potential clinically significant medication issues?” There was no documentation identifying what issues were identified with the medication review. Additionally, It was noted that the patient was prescribed 5 Cardiovascular agent medications (Amlodipine, Atorvastatin, Hydralazine, Nitroglycerin and Torsemide). Review of the drug interactions within the agency’s EMR system, the duplication of Cardiovascular agents and Antihypertensive medications was not displayed. There was no documented evidence in the Comprehensive Assessment or agency Medication Profile for this patient that the RN identified the duplication of drug therapy for the 5 Cardiovascular agent medications prescribed. There was no evidence that the RN reviewed the duplicate drug therapy with the physician as agency policy requires. These findings were reviewed with and acknowledged by Adm-1 (Administrator) during an interview on 5/16/25 at 12:35 pm.”

“Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient’s mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure that orders for frequency and duration of visits were included on the Plan of Care in 2 of 7 records reviewed (Patient #5, 7); and the agency failed to ensure the goals on the Plans of Care were objectively measurable to determine the patient’s progress towards obtaining the goals in 8 of 10 records (Patient #1, 4, 5, 6, 7, 8, 9, 10) reviewed resulting in the inability to determine the patient’s progress towards obtaining the goals. Findings included: Patient #1 (P-), a 95-year-old was admitted to agency on 1/17/24 with diagnoses including Crohn’s disease (inflammatory bowel disease) and a suprapubic cystostomy (surgical opening of the urinary bladder to drain urine). The Plan of Care (POC) dated 5/11/25 to 7/9/25 was reviewed on 5/14/25. During review, the following examples of skilled nursing (SN) goals for care were noted: Patient’s medical condition will remain stabilized within the cert period; The patient’s pain will be managed as verbalized by the patient within 9 -weeks; Patient will be free of signs and symptoms of heart failure during the certification period. It was unclear how these goals would be objectively measured to determine progress toward the goals. This finding was reviewed and acknowledged by the Administrator (Adm-1) during an interview on 5/16/25 at 10:50 a.m. Patient #4 (P-4): This 72-year-old patient was admitted to this home health agency on 2/21/25 with the diagnoses of malignant neoplasm of the brain and left lower leg deep vein thrombosis (blood clot). During record review on 5/15/25, the following examples of skilled nursing goals were listed on the plan of care: -Patient’s cardiac status will remain within normal limits for this patient without further progression of complications during the certification period. -Patient/caregiver will be knowledgeable of anticoagulation/bleeding precautions and appropriate actions to take within 4 weeks. -The patient’s pain will be managed as verbalized by the patient during cert period. -Patient/caregiver will be knowledgeable of DVT disease process and appropriate actions to take within 4 weeks. These goals lack measurable, quantifiable data to assess progress towards meeting them. The Administrator (Adm-1) reviewed and acknowledged the findings listed above during an interview on 5/16/25 at 10:04 AM. Patient #8’s (P-8) Start of Care (SOC) was dated 4/17/25. The Plan of Care (POC) identified diagnoses of Ureteral Calculus, Urinary Tract Infection and Acute Kidney Infection. During record review on 5/15/25, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Patients medical condition will remain stabilized within certification period.” Additionally, another goal stated, “Patient/caregiver will comply with prescribed medications during cert period.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. Patient #9’s (P-9) Start of Care (SOC) was dated 4/11/25. The Plan of Care (POC) identified diagnoses of Right Buttock Pressure Ulcer Stage 2, Congestive Heart Failure and Chronic Kidney Disease. During record review on 5/15/25, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Patient will receive appropriate wound care as ordered by physician during plan of care.” Additionally, another goal stated, “Patient will be free from contracting COVID-19 through certification period.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. Patient #10’s (P-10) Start of Care (SOC) was dated 11/18/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure and Diabetes Type 2. During record review on 5/13/25, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Patient will be free of exacerbation from --- disease process --- within 60 days.” Additionally, another goal stated, “Patient will be free from contracting COVID-19 through certification period.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. The Administrator (ADM-1) reviewed and acknowledged the findings listed about in an interview on 5/16/25 at 12:10 pm. ***Agency Policy: Plan of Care-CMS #485 and Physician/Practitioners Orders. The policy states, “The individualized plan of care must include the following: The frequency and duration of visits to be made.” ***Agency Policy: Plan of Care-CMS #485 and Physician/Practitioners Orders: The policy states, “The individualized Plan of Care must include the following: “Patient-specific interventions and education, measurable outcomes and goals identified by the Agency and patient.” Patient #5’s (P-5) Start of Care was dated 1/31/2025. The Plan of Care for the certification period 4/1/2025 to 5/3/2025 identified diagnoses of Diabetes Type 2 with foot ulcer, non-pressure chronic ulcer of right heel and midfoot with necrosis, Encounter for surgical after care, Coronary Artery Disease, and Hypertensive heart disease with heart failure. The patient was receiving Skilled Nursing (SN) services 2 times weekly, however, there was no information found in the record that included orders for the duration of visits. The physician failed to include orders for duration of visits on the Plan of Care. In addition, upon review of the Plan of Care, it was noted the goals on the Plan of Care were not objectively measurable to determine the patient’s progress towards obtaining the goals. Examples included: “Patient/Caregiver will verbalize understanding of Ambulation safety and fall precautions within certification period” {sic}; “Patient/caregiver will be knowledgeable about skin/foot care and breakdown prevention within cert period {sic}”; Patient will elevate legs while sitting and watch for any weight gain and how and when to seek medical assistance; Patient/Caregiver will verbalize understanding of medication safety techniques within cert period {sic}.” These goals are not objectively measurable to determine the patient’s progress towards obtaining the goals. P-6’s (P-6) Start of Care (SOC) was dated 3/7/2025. The Plan of Care (POC) for the certification Period 3/7/2025 to 5/5/2025 identified diagnoses of Trochanter’s Bursitis of Left Hip, Alzheimer’s Disease, Atrioventricular Blockage, Coronary Artery Disease, Dizziness and Giddiness. Upon review of the Plan of Care, it was noted the goals on the POC were not objectively measurable to determine the patient’s progress towards obtaining the goals. Examples included: “Patient will have assistance with personal care and IADLS (Instrumental Activities of Daily Living) with the assistance of the home health aide during plan of care; Patient will remain neat, clean and odor free throughout certification period; Patient’s safety will be enhanced throughout the home care service as evidenced by no injuries through 9 weeks; Patient will be free from any falls during episode.” These goals are not objectively measurable to determine the patient’s progress towards obtaining the goals. P-7’s (P-7) Start of Care was dated 1/31/2025. The Plan of Care for the certification period 4/1/2025 to 5/30/2025 identified diagnoses of Diabetes type 2, non-pressure chronic ulcer of right heel and midfoot with necrosed bone; Encounter for surgical after-care following surgery on the circulatory system, Atherosclerotic Heart Disease of Native Coronary Artery with unspecified Angina Pectorus; Hypertensive Heart Disease with Heart Failure; Chronic Combined Systolic and Diastolic Heart Failure. The Plan of Care included orders for Skilled Nursing Services two times a week. However, there was no information found in the record that included orders for duration of Skilled Nursing Services. In addition, the Plan of Care for the certification period 4/1/2025 to 5/30/2025 identified diagnoses of Diabetes type 2, non-pressure chronic ulcer of right heel and midfoot with necrosed bone; Encounter for surgical after-care following surgery on the circulatory system, Atherosclerotic Heart Disease of Native Coronary Artery with unspecified Angina Pectorus; Hypertensive Heart Disease with Heart Failure; Chronic Combined Systolic and Diastolic Heart Failure. The patient was receiving Skilled Nursing Services two times a week. Upon review of the Plan of Care it was noted the goals on the Plan of Care were not objectively measurable to determine the patient’s progress towards obtaining the goals. Examples include: “Patient/Caregiver will verbalize understanding of ambulation safety and fall precautions within cert period; Patient/caregiver will be knowledgeable about skin/foot care and breakdown prevention within cert period; Patient will maintain appropriate nutrition/hydration status to avoid wound healing complications within certain period {sic}. These goals are not objectively measurable to determine the patient’s progress towards obtaining the goals. The Administrator (Adm-1) reviewed and acknowledged the findings listed above during an interview on 5/16/25 at 11:35 AM.”

“Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient’s condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This Element is not met as evidenced by: Based on record review and interview, the agency failed to promptly notify the Physician concerning a vital sign outside of the specified reportable parameters for 1 (P-10) of 10 records reviewed, resulting in a potential poor clinical outcome. Findings include: A review of the agency policy: “Plan of Care – CMS #485 and Physician/Practitioners Orders” (Revised April 2023). The policy states, “Procedure: 20. Care and services provided will be provided according to physician/practitioner orders. Orders are current and updated. 21. Drug, services and treatments are administered by staff only as ordered by physician/practitioner.” Patient #10’s (P-10) Start of Care (SOC) was dated 11/18/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure and Diabetes Type 2. During record review on 5/13/25, it was noted that the POC noted “Parameters to Notify Physician” stating, “Pulse Ox The was no documented evidence of the PT reporting the low O2 reading. The PT failed to notify the physician as per policy. The Administrator (ADM-1) reviewed and acknowledged the findings listed about in an interview on 5/16/25 at 12:10 pm.”

“Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This Element is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure the home health aide provided only the services which were included in the Plan of Care in 1 (P-1) of 1 observation for which a joint home visit was conducted with the home health aide, resulting in unsafe care and the potential for a poor patient outcome. Findings include: Patient #1 (P-1), a 95-year-old was admitted to agency on 1/17/24 with diagnoses including Crohn’s disease (inflammatory bowel disease) and a suprapubic cystostomy (surgical opening of the urinary bladder to drain urine through a catheter). On 5/13/25, the Comprehensive Recertification Assessment dated 5/7/25 was reviewed and revealed that P-1 was a high fall risk, legally blind, and used a wheelchair or walker for ambulation. During review of the Aide Plan of Care (care instructions for the aide), it was noted under the heading “Activities: Assist with Ambulation/Assistive Device Use” that the assistive ambulation device marked with a check box included “Wheel Chair” and a note was entered next to the checked box which stated, “Assist as needed”. There were no other instructions given for how the patient transferred, ambulated, or other devices (such as a walker). On 5/14/25 a joint home visit was conducted with the home health aide (HHa) at 8 a.m. The HHa was scheduled to perform a shower with P-1 during the visit. Upon entrance into the home, P-1 was observed sitting in a wheelchair in the kitchen. When the HHa told P-1 that everything was ready for the shower, P-1 began to self-propel the wheelchair toward the bathroom (off the living room). There was a narrow entrance to the bathroom due to clutter, so P-1 stopped the wheelchair a few feet from the bathroom, stood up, gathered up the suprapubic catheter in one hand, and began to walk into the bathroom while the HHa watched. There was no assistive device used, and there was no assistance from the HHa. P-1 prepared for entering the shower by undressing while sitting on the toilet and then walked a few steps to the tub/shower with no assistance or assistive devices. After the shower was complete and P-1 was redressed, P-1 walked unassisted a few feet back to the wheelchair. The HHa was asked if the patient used a device for assistance when walking. The HHa replied “no” and stated that P-1 could walk into the bathroom. The HHa did not provide only the services as written in the Aide Plan of Care (assist with wheelchair). The Administrator (Adm-1) reviewed and acknowledged the findings above during an interview on 5/16/25 at 10:50 a.m.”

“Duties of a HH aide CFR(s): 484.80(g)(3) The duties of a home health aide include: (i) The provision of hands-on personal care; (ii) The performance of simple procedures as an extension of therapy or nursing services; (iii) Assistance in ambulation or exercises; and (iv) Assistance in administering medications ordinarily self-administered. This Element is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure the home health aide provided only a passive role in assisting the patient with a medication in 1 (P-1) of 1 observation for which a joint home visit was conducted with the home health aide, potentially resulting in unintended consequences of a medication misadministration. Findings include: Patient #1 (P-1), a 95-year-old was admitted to agency on 1/17/24 with diagnoses including Crohn’s disease (inflammatory bowel disease) and a suprapubic cystostomy (surgical opening of the urinary bladder to drain urine through a catheter). The Aide Plan of Care (care instructions for the aide) was reviewed on 5/13/25 and it was noted that the instructions included the following skin care related duties: Skin Care (under “Grooming”); Report to SN (skilled nurse) any new skin or wound breakdown; apply skin barrier. On 5/14/25 a joint home visit was conducted with the home health aide (HHa) at 8 a.m. The HHa was scheduled to perform a shower with P-1 during the visit. After the shower the HHa was observed while applying (sprinkling) a powder around the stoma (cystostomy opening) on the patient’s abdomen. It was noted the powder was a physician prescribed antifungal medication called Nystatin Powder. The HHa was asked what the powder was and stated it was Nystatin and that the nurse knew she put it on P-1. Upon detailed review of the medical record on 5/14/25, it was noted that the nurse instructed the patient’s caregiver on use and application of the Nystatin Powder during a visit on 2/4/25. The Nystatin Powder was on the medication profile and the instructions included: small amount, external, new, powder until healed. The HHa actively applied a prescription medication. The findings were reviewed with the Administrator (Adm-1) during an interview on 5/16/25 at 10:50 a.m. Adm-1 was asked what was meant by “skin barrier” on the Aide Plan of Care. Adm-1 stated that a skin barrier was an over the counter (non-prescribed) ointment or cream. Adm-1 agreed that Nystatin was a physician prescribed medication which should not be applied by the HHa.”

“Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record contained all interventions, treatments, services, and responses to treatment in 2 (Patient #3, 4) of 10 records reviewed, resulting in an incomplete medical record. Findings include: P-3: This 83-year-old patient was admitted to this home care agency on 3/20/25 with the diagnoses of surgical care after surgery on the genitourinary system (for kidney stones), urinary tract infection, cardiomyopathy, and type II diabetes mellitus. During record review on 5/14/25, it was noted the physical therapy notes (dated 4/3/25, 4/10/25, and 4/23/25) each listed the exercises performed by the patient, however, a generalized range of repetitions was given below (5-10, 7-10, etc). It is unclear how many repetitions of each exercise the patient performed; therefore, the record is an inaccurate and incomplete representation of the patient’s treatment. Patient #4 (P-4): This 72-year-old patient was admitted to this home health agency on 2/21/25 with the diagnoses of malignant neoplasm of the brain and left lower leg deep vein thrombosis (blood clot). During record review on 5/15/25, it was noted the physical therapy notes (dated 2/24/25, 2/26/25, 3/3/25, 3/5/25, 3/17/25, 3/31/25, and 4/9/25 ) each listed the exercises performed by the patient, however, a generalized range of repetitions was given below (5-10, 10-10, etc). It is unclear how many repetitions of each exercise the patient performed; therefore, the record is an inaccurate and incomplete representation of the patient’s treatment. Additionally, upon review of the occupational therapy note dated 3/5/25, it was documented that the occupational therapist, “Educated on exercises to complete with theraputty” and “Provided hand exercises to address fine motor coordination.” There were no further details regarding what specific exercises or instructions were given; therefore, the record is an inaccurate and incomplete representation of the patient’s treatment. The Administrator (Adm-1) reviewed and acknowledged the findings listed above during an interview on 5/16/25 at 10:04 AM.”

“Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient’s discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient’s care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This Element is not met as evidenced by: Based on record review, policy review, and interview, the agency failed to complete a transfer and/or discharge summary that included all pertinent information and was sent to the physician in 3 of 3 transferred/discharged records reviewed (P-6, P-7, P-10), resulting in no information regarding the goals accomplished during the course of care, and the patient’s condition at discharge. Findings include: Patient #10’s (P-10) Start of Care (SOC) was dated 11/18/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure and Diabetes Type 2. During record review on 5/13/25, it was noted that the Skilled Nursing “Discharge Summary” dated 1/16/25 stated, “Discharge Date: 1/15/25. Discharged to: Hospital. Reason for Discharge: Hospitalized. Comments: Blank…Patient Status at Time of Discharge: Blank. Significant Health History: Blank…” The discharge summary failed to detail the course of care provided, responses to treatment, any potential continuing needs, reason for discharge and failed to document the patient’s health status at the time of discharge. The Administrator (ADM-1) reviewed and acknowledged the findings listed about in an interview on 5/16/25 at 12:15 pm. **Agency Policy: Discharge Summary. The Policy states, “A discharge summary will be completed for all patients discharged from the agency. Purpose: To record a summary of care received by the patient from the start of care through discharge. The discharge summary will include Discharge date, reason for discharge, laboratory data, patient’s discharge condition, types of services provided and frequency of services, patient’s outcomes in meeting goals in the plan of care, Patient/family post-discharge instructions, goals and treatment preferences, medications at time of discharge. The discharge summary will be sent within 5 business days of patient discharge to the physician. Patient/family post-discharge instructions, goals and treatment preferences. Medications at time of discharge. A discharge summary form will be filed from each service and will be filed in the medical record. The summary will include all necessary medical information pertaining to the patient’s current course of illness and treatment, including post-discharge goals of care and treatment preferences. The agency will comply with requests for additional clinical information as may be necessary for treatment made by the receiving facility or practitioner. Patient #5’s (P-5): Start of Care was dated 1/31/2025. The Plan of Care for the certification period 4/1/2025 to 5/3/2025 identified diagnoses of Diabetes Type 2 with foot ulcer, non-pressure chronic ulcer of right heel and midfoot with necrosis, Encounter for surgical after care, Coronary Artery Disease, and Hypertensive heart disease with heart failure. The patient was receiving Skilled Nursing (SN) services 2 times weekly, however, there was no information found in the record that included orders for the duration of visits. This patient was discharged from the agency on 4/1/25 and transferred to a Skilled Nursing Facility. Upon review of the record, it was noted the Discharge Summary was void of Important information as follows: Nutritional Requirements: Generic. There was no information under the following Categories: Clinical Summary/Lab Data; Skin/Wound Care; Surgical Procedures; Allergies; Patient and/or Family Post-Discharge Instructions; Vital Signs; Patient Status at Time of Discharge from prior agency; Significant Health History. There was no indication or documentation that the Discharge Summary had been sent to the Physician. That area of the Discharge Summary was blank. Patient’s #6’s (P-6): Start of Care (SOC) was dated 3/7/2025. The Plan of Care (POC) for the certification Period 3/7/2025 to 5/5/2025 identified diagnoses of Trochanterus Bursitis of Left Hip, Alzheimer’s Disease, Atrioventricular Blockage, Coronary Artery Disease, Dizziness and Giddiness. The patient was receiving Skilled Nursing, Physical Therapy, and Occupational Therapy Services. Upon review of the record, it was noted the Discharge Summary was missing pertinent information as follows: Laboratory data, Patient’s discharge condition, Patient outcomes in meeting the goals in the Plan of Care, Patient and Family post-discharge instructions, current medication list, evidence that the discharge summary was sent to the primary care provider and to the nursing home facility in which the patient had been transferred. The Administrator (Adm-1) reviewed and acknowledged the findings listed above during an interview on 5/16/25 at 11:35 AM.”