Comfort Care Medicare Inc.

“Condition of Participation: Patient rights. CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient’s rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This Condition is not met as evidenced by: Based on clinical record review, home visit observation, agency policy review and agency staff interview, the agency failed to ensure the patient had the right to participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to completion of all assessments, care to be furnished, establishing and revising the plan of care, disciplines that will furnish the care, frequency of visits, expected outcomes of care, factors that could impact treatment effectiveness, and any changes in the care to be furnished. (G434) The cumulative and egregious effects of these systemic practices resulted in the failure to ensure the organizational framework of the agency promoted and supported the coordination of safe and effective delivery of care to the agency’s 216 patients.”

“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 staff interviews, agency policy, and clinical record review and the agency failed to follow a Plan of Care (POC) established and periodically reviewed by a physician or notify the physician of the need to vary frequency of visits or inability to perform treatments/services as originally ordered on the Plan of Care (POC) for 3 of 6 sampled patients (Patients #2, #3, and #5). Failure to follow a Plan of Care (POC) established by home health clinical associates in collaboration with the patient’s physician, placed patients at risk of not receiving safe, individualized and consistent care designed to meet each patient’s health care needs. Findings include: 3. Patient #3 had a start of care date of 3/23/22. Clinical record review revealed: a. Plans of Care, dated 11/2/25 to 12/31/25 and 1/1/26 to 3/1/26, included primary diagnosis of chronic obstructive pulmonary disease and physician orders for skilled nursing services once a week and home health aide services twice a week. b. Unsigned Occupational Therapy (OT) orders, dated 12/4/25, signed by Staff I, OT included services to be provided twice a week. c. Occupational therapy visit notes, dated 12/10/25 and 12/15/25, signed by Staff K, COTA (certified occupational therapy assistant) identified visits were completed. The clinical record failed to identify a second occupational therapy visit for the weeks of 12/7/25 and 12/14/25, a reason why the visits were not made or documentation the physician was notified. d. Home health aide visit note, dated 12/22/25, signed by Staff J, Home Health Aide, identified visit was completed. The clinical record failed to identify a second home health aide visit for the week of 12/21/25, a reason why the visit was not made or documentation the physician was notified. The agency failed to provide occupational therapy and home health aide services as ordered or notify the physician of the missed visits. Findings were reviewed with Staff B, Director of Human Resources and Staff F, Office Manager. According to agency policy titled Care Planning Process, updated August 2025, on the occasion of a missed visit for all disciplines, due to a change in frequency, a missed visit report is filled and faxed to the doctor. In an interview on 2/4/26 at 9:12 AM, Staff, Office Manager, reported that she was not able to find missed visit notification to the doctor for missed visits from Patients #2 and Patient #5. Staff F reported that home health aides inform her when they miss a visit and then Staff F sends missed visit notification to the doctor. Staff F reported nurses send missed visit notification to the doctor when they miss a nursing visit. 1.Patient #2 had a start of care date of 5/22/24. Clinical record review revealed: a.The Plan of Care (POC) dated 11/13/25 to 1/11/26 included orders for 1 skilled nursing visit per week and 2 home health aide visits per week. The patient had a diagnosis of chronic obstructive pulmonary disease (COPD). b. The clinical record lacked documentation of skilled nurse services for the week of 1/4/26, and lacked physician notification of the missed visit. c. The Clinical record lacked documentation of a second home health aide visit the week of 12/28/25 and lacked physician notification of the missed visit. The agency failed to provide skilled nursing services or home health aide services as ordered or notify the physician of the missed visits. 2.Patient #5 had a start of care date of 8/17/23. Clinical record review revealed: a.The Plan of Care (POC) dated 12/4/25 to 2/1/26 included orders for 1 skilled nursing visit per week. The Plan of Care (POC) did not include the patient’s diagnosis. b. The clinical record lacked documentation of skilled nurse services the week of 12/28/25 and the week of 1/25/26, and lacked physician notification of the missed visits. The agency failed to provide skilled nursing services as ordered or notify the physician of the missed visits.”

“Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This Element is not met as evidenced by: Based on staff interview, agency policy review, and clinic record review, the agency failed to ensure the patient participated in, was informed about, and gave consent or refused care in advance of and during treatment for 6 of 6 sampled patients (Patients #1, #2, #3, #4, #5, and #6). Failure to ensure agency staff ensured the patient participated in, was informed about, and gave consent or refused care in advance of and during treatment before the agency initiated care or during care placed agency patient at risk for the patient’s rights being violated and services provided without consent. Findings include: 5. Patient #1 had a start of care date of 1/5/26. Clinical record review revealed: a. Plan of Care, dated 1/5/26 to 3/5/26, included primary diagnosis of cardiomyopathy and physician orders for skilled nursing, home health aide, physical therapy and occupational therapy services. During an interview on 2/3/26 at 2:52 PM, Staff F, Office Manager, surveyor requested to review copies of admission consents, Staff F reported the consents should have been scanned into the electronic medical record by now, she would look for them and provide to surveyor. During an interview on 2/4/26 at 8:35 AM, Staff F, reported agency was unable to locate the admission consents. 6. Patient #3 had a start of care date of 3/23/22. Clinical record review revealed: a. Plan of Care, dated 1/1/26 to 3/1/26, included primary diagnosis of COPD and physician orders for skilled nursing and home health aide services. b. Admission consents, signed by patient and dated 3/23/22. Clinical record lacked documentation of annual consent forms completed for years 2023, 2024 or 2025. Findings were reviewed with Staff B, Director of Human Resources and Staff F, Office Manager. According to the agency policy titled Admission Documents, updated August 2024, annual admission consents and releases of information will be reviewed and signed by the patient and clinician. According to the agency policy titled Admission Criteria and Process, updated August 2024, the patient or his/her representative will sign the required forms indicating acceptance of services and receipt of patient rights and privacy information. 1.Patient #2 had a start of care date of 5/22/24. Clinical record review revealed: The Plan of Care (POC) dated 1/12/26 to 3/12/26 included orders for skilled nursing and home health aide services. The patient had a diagnosis of chronic obstructive pulmonary disease (COPD). Review of the clinical record failed to include an annual admission consent signed by the patient and clinician. 2.Patient #4 had a start of care date of 3/6/24. Clinical record review revealed: The Plan of Care (POC) dated 12/26/25 to 2/23/26 included orders for skilled nursing, home health aide, and physical therapy. The patient had a diagnosis of encephalopathy (disease of the brain that alters brain function or structure). Review of the clinical record failed to include an annual admission consent signed by the patient and clinician. In an interview on 2/3/26 at 9:43 AM, Staff F, Office Manager, reported that she and Staff B, Director of Human Resources, were not able to locate Patient #4’s annual consents. Staff F reported that the patient should have annual paperwork in the chart. 3. Patient #6 had a start of care date of 8/15/24. Clinical record review revealed: The Plan of Care (POC) dated 12/8/25 to 2/5/26 included orders for skilled nursing and home health aide. The patient had a diagnosis of chronic obstructive pulmonary disease (COPD). Review of the clinical record failed to include an annual admission consent signed by the patient and clinician. 4.Patient #5 had a start of care date of 8/17/23. Clinical record review revealed: a.The Plan of Care (POC), dated 12/4/25 to 2/1/26, included orders for skilled nursing. The Plan of Care (POC) did not include a diagnosis. b.Review of the clinical record failed to include an annual admission consent signed by the patient and clinician. 1. Patient #1 had a start of care date of 1/5/26. Clinical record review revealed: a. Plan of Care, dated 1/5/26 to 3/5/26, included primary diagnosis of cardiomyopathy and physician orders for skilled nursing, home health aide, physical therapy and occupational therapy services. During an interview on 2/3/26 at 2:52 PM, Staff F, Office Manager, surveyor requested to review copies of admission consents, Staff F reported the consents should have been scanned into the electronic medical record by now, she would look for them and provide to surveyor. During an interview on 2/4/26 at 8:35 AM, Staff F, confirmed the agency was unable to locate Patient #1’s admission consents. Review of the clinical record failed to include an annual admission consent signed by the patient and clinician. According to the agency policy titled Admission Documents, updated August 2024, annual admission consents and releases of information will be reviewed and signed by the patient and clinician. 2.Patient #2 had a start of care date of 5/22/24. Clinical record review revealed: The Plan of Care (POC) dated 1/12/26 to 3/12/26 included orders for skilled nursing and home health aide services. The patient had a diagnosis of chronic obstructive pulmonary disease (COPD). Review of the clinical record failed to include an annual admission consent signed by the patient and clinician. 2.Patient #4 had a start of care date of 3/6/24. Clinical record review revealed: The Plan of Care (POC) dated 12/26/25 to 2/23/26 included orders for skilled nursing, home health aide, and physical therapy. The patient had a diagnosis of encephalopathy (disease of the brain that alters brain function or structure). Review of the clinical record failed to include an annual admission consent signed by the patient and clinician. In an interview on 2/3/26 at 9:43 AM, Staff F, Office Manager, reported that she and Staff B, Director of Human Resources, were not able to locate Patient #4’s annual consents. Staff F reported that the patient should have annual paperwork in the chart. 3. Patient #6 had a start of care date of 8/15/24. Clinical record review revealed: The Plan of Care (POC) dated 12/8/25 to 2/5/26 included orders for skilled nursing and home health aide. The patient had a diagnosis of chronic obstructive pulmonary disease (COPD). Review of the clinical record failed to include an annual admission consent signed by the patient and clinician. 4.Patient #5 had a start of care date of 8/17/23. Clinical record review revealed: a.The Plan of Care (POC), dated 12/4/25 to 2/1/26, included orders for skilled nursing. The Plan of Care (POC) did not include a diagnosis. b.Review of the clinical record failed to include an annual admission consent signed by the patient and clinician. 5. Patient #1 had a start of care date of 1/5/26. Clinical record review revealed: a. Plan of Care, dated 1/5/26 to 3/5/26, included primary diagnosis of cardiomyopathy and physician orders for skilled nursing, home health aide, physical therapy and occupational therapy services. During an interview on 2/3/26 at 2:52 PM, Staff F, Office Manager, surveyor requested to review copies of admission consents, Staff F reported the consents should have been scanned into the electronic medical record by now, she would look for them and provide to surveyor. During an interview on 2/4/26 at 8:35 AM, Staff F, reported agency was unable to locate the admission consents. 6. Patient #3 had a start of care date of 3/23/22. Clinical record review revealed: a. Plan of Care, dated 1/1/26 to 3/1/26, included primary diagnosis of COPD and physician orders for skilled nursing and home health aide services. b. Admission consents, signed by patient and dated 3/23/22. Clinical record lacked documentation of annual consent forms completed for years 2023, 2024 or 2025. Findings were reviewed with Staff B, Director of Human Resources and Staff F, Office Manager.”

“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 staff interview, agency policy, and clinical record, the agency failed to include the patient’s diagnosis on the Plan of care (POC) for 1 of 6 patient reviewed (Patient #5). Failure to maintain complete and accurate POCs with current orders placed patients at risk to not receive services, supplies, medications, and/or treatment according to assessed needs and physician orders. Findings include: According to the agency policy titled Care Planning Process, updated August 2025, the clinical POC includes pertinent primary and secondary diagnoses. Patient #5 had a start of care date of 8/17/23. Clinical record review revealed: The POC, dated 12/4/25 to 2/1/26 did not include the patient’s diagnosis. The agency failed to include all required components of the POC, to include diagnosis. In an interview on 2/3/26 at 11:33 AM, Staff F, Office Manager, reviewed the patient’s POC and confirmed that the diagnosis was not included. The above findings were reviewed with the Director of Human Resources and Office Manager.”

“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 agency policy review, clinical record review and agency staff interview, the agency failed to provide medications, treatments or services only as ordered by the physician for 3 of 4 sampled patients with therapy services (Patients #1, #2, and #3). Failure to ensure staff obtain physician orders for administration of medications, treatments or services provided by agency staff placed agency patients at risk for inconsistent care/treatment and possible harm. Findings include: 2. Patient #1 had a start of care date of 1/5/26. Clinical record review revealed: a. Plan of Care, dated 1/5/26 to 3/5/26, included primary diagnosis of cardiomyopathy and physician orders for physical therapy and occupational therapy services to evaluate and treat. b. Physical Therapy (PT) evaluation and plan of treatment, dated 1/9/26, signed by Staff L, PT, included orders for physical therapy one time a week for one week and then two times a week for 60 days. The document was unsigned by a physician. c. Physical Therapy visit notes, dated 1/14/26, 1/16/26, 1/19/26, 1/21/26, 1/26/26 and 1/30/26, signed by Staff M, PTA (physical therapy assistant) included documentation services were provided. d. Occupational Therapy evaluation and plan of treatment, dated 1/9/26, signed by Staff I, OT, included orders for occupational therapy one time a week for one week and then two times a week for 60 days. The document was unsigned by a physician. e. Occupational Therapy visit notes, dated 1/13/26, 1/16/26, 1/19/26, 1/23/26, 1/27/26 and 1/29/26, signed by Staff K, COTA (certified occupational therapy assistant), included documentation services were provided. During an interview on 2/3/26 at 4:00PM, Staff B, Director of Human Resources, reported therapy evaluations are not getting printed out and sent to the physician for signature. This was identified when printing documents for surveyor. All orders were printed out today and faxed to physician. The agency provided Physical Therapy and Occupational Therapy services without a physician order. 3. Patient #3 had a start of care date of 3/23/22. Clinical record review revealed: a. Plans of Care, dated 11/2/25 to 12/31/25, included primary diagnosis of chronic obstructive pulmonary disease and physician orders for occupational therapy services to evaluate and treat. b. Plans of Care, dated 1/1/26 to 3/1/26, included primary diagnosis of chronic obstructive pulmonary disease and physician orders for skilled nursing and home health aide services. c. Occupational Therapy reassessment notes, dated 12/4/25 and 1/2/26, signed by Staff I, OT, included orders for occupational therapy two times a week for up to 60 days. The documents were unsigned by a physician. d. Occupational Therapy visit notes, dated 12/10/25, 12/15/25, 12/23/25, 12/30/25, 1/6/26, 1/14/26 and 1/15/26, signed by Staff K, COTA, included documentation services were provided. e. Occupational Therapy visit notes, dated 12/24/25, 1/2/26 and 1/9/26, signed by Staff I, OT, included documentation services were provided. The agency provided Occupational Therapy services without a physician order. Findings were reviewed with Staff B, Director of Human Resources and Staff F, Office Manager. 1.Patient #2 had a start of care date of 5/22/4. Clinical record revealed: a.The Plan of Care (POC) dated 11/13/25 to 1/11/26 included a diagnosis of chronic obstructive pulmonary disease (COPD) and order for Occupational Therapy (OT) to evaluate and treat the patient. b.The OT evaluation, dated 11/13/25, signed by Staff I, Occupational Therapist (OT), included orders for OT services 1 visit for 1 week and then 2 visits per week for 60 days. The order was not signed by the physician. c.OT visit notes, dated 11/26/25 and 12/4/25, signed by Staff K, PTA (physical therapy assistant) included documentation services were provided. OT visit note, dated 12/11/25, signed by Staff N, OT, included documentation services were provided. The agency provided OT services to the patient without a physician’s order.”

“Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: Based on review of the agency’s emergency preparedness plan, related policies and procedures and staff interview, the agency failed to ensure the emergency preparedness plan reviewed every 2 years. Failure to ensure the integrated health emergency preparedness plan reviewed every 2 years placed patients at risk for the agency failing to have resources and/or the means to provide services to agency patients during a time of disaster or emergency. Findings include: Review of the agency’s emergency preparedness plan identified the plan last reviewed on 7/1/2021. The plan identified how the agencies involved in the plan would respond to various disasters and emergencies. During an interview on 8/14/24 at 8:55 AM Staff B, Human Resources Manager stated the agency did not have an updated emergency plan. The findings were reviewed with the Administrator, Human Resource Manager, Corporate Liaison, Staff C, Nursing Supervisor and Staff D, Nursing Supervisor.”

“HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA’s patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This Standard is not met as evidenced by: Based on review of agency’s emergency preparedness plan/policies, review of the agency’s admission packet, clinical record review, home visit observation and agency staff interview, the home health agency failed to complete an individualized emergency plan developed as part of the comprehensive assessment, maintaining documentation of the plan in the patient’s chart and in the patient’s home setting, for 1 of 3 sampled patients with home visits (Patient #3). Failure to ensure the agency completed an individualized emergency plans developed as part of the comprehensive assessment and failure to ensure the patient has knowledge of the identified Plan placed patients at risk for staff being unaware and unprepared to respond in a timely and effective manner to potential health and safety hazards the patient may encounter. Findings include: According to the agency’s policy titled Emergency Preparedness Plan, dated July 1, 2021, detailed written instructions will be given to patients and/or family members to ensure an appropriate and timely response in the event of an emergency event that may cause interruptions of services. Information provided may include: emergency contact telephone numbers, names of contact persons, local resources, evacuation routes, availability of local shelters and other community resources, methods to obtain needed medications, supplies, and equipment and necessity of having a plan for obtaining food/water, caring for pets and obtaining important documents. Patient #3 had a start of care date of 8/2/24. Clinical record review revealed the following: a. The Plan of Care (POC), dated 8/2/24 to 9/30/24, included the diagnosis of Type II diabetes mellitus with diabetic neuropathy. b. The POC, dated 8/2/24 to 9/30/24, identified an emergency preparedness assessment of Level 3. The assessment identified the plan was reviewed with the patient but lacked documentation the emergency plan was provided to the patient. c. During a home visit observation on 8/13/24 with Staff F, Physical Therapy Assistant (PTA), review of the agency’s admission packet provided to the patient included a blank emergency care plan form but did not include an individualized emergency plan. The agency failed to provide the patient with a written completed individualized emergency plan. The findings were reviewed with the Administrator, Human Resource Manager, Corporate Liaison, Staff C, Nursing Supervisor and Staff D, Nursing Supervisor.”

“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 agency staff interview, agency policy review and review of emergency preparedness testing documentation, the agency failed to ensure participation an emergency preparedness exercises annually. Failure to conduct or participate in emergency preparedness exercises placed patients at risk for not having trained and prepared staff to assist them in the event of an emergency. Findings include: According to the agency policy, titled Emergency Preparedness Policy and dated 7/1/21, the emergency preparedness testing requirement exercises will be conducted at least bi-annually and will focus on the organization’s response to an emergency that is likely to affect continuation of care, treatment or services. Exercise scenarios will allow the organization to evaluate its handling of communication, resources and assets, staff and patients One drill will be agency wide and one will be a full-scale. Emergency preparedness training documentation included an emergency preparedness exercise, dated 9/15/23. The agency lacked any documentation of an additional training exercise in 2022. During an interview on 8/14/24 at 8:55 AM, Staff B, Human Resources Manager reported that the agency did not participate in an additional exercise in 2022. The findings were reviewed with the Administrator, Human Resource Manager, Corporate Liaison, Staff C, Nursing Supervisor and Staff D, Nursing Supervisor.”

“Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient’s current health, psychosocial, functional, and cognitive status; This Element is not met as evidenced by: Based on clinical record review, agency policy review, and agency staff interview, the agency failed to comprehensively provide wound assessments for 1 of 3 sampled patients with wounds (Patients #7) and failed to provide a comprehensive patient assessment with recertification assessments 1 of 2 patients with wounds (Patient #7). Failure to accurately and thoroughly complete wound assessments or provide a comprehensive assessment placed patients at an increased risk of unidentified condition changes. Findings include: Patient #7 had a Start of Care date of 8/30/23 and a Discharge date of 12/15/23. Clinical record review revealed the following: a. The Plans of Care, dated 8/30/23 to 10/28/24 and 10/29/24 to 12/27/2023, included orders for skilled nursing services weekly. b. Start of care comprehensive assessment, dated 8/30/23, included documentation the patient had a Stage 2 pressure ulcer but lacked wound location or measurements. c. Discharge comprehensive assessment, dated 12/15/23, included documentation the patient had Stage1 pressure ulcer, Stage 2 pressure ulcer and 1 deep tissue injury but lacked wound location or measurements. d. Skilled nursing visit note, dated 10/20/23, included documentation of left outer ankle wound and left lateral below knee high calf burn but lacked documentation of wound measurements. e. Skilled nursing visit note, dated 11/10/23, lacked documentation of wounds. f. Skilled nursing visit note, dated 11/17/23, included documentation of left outer ankle wound, right outer ankle wound and left lateral below knee high calf burn but lacked documentation of wound measurements. g. Skilled nursing visit note, dated 11/24/23, included documentation of multiple wounds but lacked documentation of wound location or measurements. h. Wound Care Flow Sheet, dated 11/24/23, included documentation of left below knee high calf wound scab, 6 centimeters (cm) x 1.5 cm; right outer ankle wound 1.5 cm x 1.5 cm; left outer ankle wound 1 cm x 1 cm; right sole area 3 cm x 2 cm; multiple high hamstring low buttocks that lacked wound measurements and multiple coccyx bone area that lacked wound measurements. The wound measurements for right outer ankle, left outer ankle and right sole area wounds lacked wound depth. i. Skilled nursing visit note, dated 12/1/23, included documentation of multiple wounds but lacked documentation of wound location or measurements. j. Wound Care Flow Sheet, dated 12/1/23, included documentation of left below knee high calf wound scab, 5 cm x 1.5 cm; right outer ankle wound 0.5 cm x 0.5 cm; left outer ankle wound 0.5 cm x 0.5 cm; right sole area 3 cm x 2 cm; multiple high hamstring low buttocks that lacked wound measurements and multiple coccyx bone area that lacked wound measurements. The wound measurements for right outer ankle, left outer ankle and right sole area wounds lacked wound depth. k. Skilled nursing visit note, dated 12/8/23, included documentation of multiple wounds but lacked documentation of wound location or measurements. l. Wound Care Flow Sheet, dated 12/8/23, included documentation of left below knee high calf wound scab, 4 cm x 1 cm; right outer ankle wound healed; left outer ankle wound healed; right sole area blister 3 cm x 2 cm; multiple high hamstring low buttocks 1 cm x 1 cm and multiple coccyx bone left of 3.5 cm x 2.5 cm x 1.5 cm. The wound measurements for multiple high hamstring low buttocks lacked wound depth. The nurse failed to obtain complete wound measurements weekly per agency policy. The agency provided no additional information prior to the end of the survey. According to the agency policy titled Wound Care Standards, dated 1/2021, at a minimum all wounds must be assessed weekly by the Registered Nurse (RN) Case Manager or designated RN. This includes measurements of length, width, and depth (when applicable). During an interview on 8/12/24 at 3:30 PM, Staff C, RN supervisor stated staff document measurements weekly on the adobe fill and sign document. The document reviewed by the RN supervisor and uploaded everyday into the electronic medical record. According to the agency policy titled Wound Care Standards, dated 1/2021, at a minimum all wounds must be assessed weekly by the Registered Nurse (RN) Case Manager or designated RN. This includes measurements of length, width, and depth (when applicable). During an interview on 8/12/24 at 3:30 PM, Staff C, RN supervisor stated staff document wound measurements weekly on the adobe fill and sign document. The document is reviewed by the RN supervisor and uploaded everyday into the electronic medical record. 1. Patient #7 had a Start of Care date of 8/30/23 and a Discharge date of 12/15/23. Clinical record review revealed the following: a. The Plans of Care, dated 8/30/23 to 10/28/24 and 10/29/24 to 12/27/2023, included orders for skilled nursing services weekly. b. Start of care comprehensive assessment, dated 8/30/23, included documentation the patient had a Stage 2 pressure ulcer but lacked wound location or measurements. c. Discharge comprehensive assessment, dated 12/15/23, included documentation the patient had Stage1 pressure ulcer, Stage 2 pressure ulcer and 1 deep tissue injury but lacked wound location or measurements. d. Skilled nursing visit note, dated 10/20/23, included documentation of left outer ankle wound and left lateral below knee high calf burn but lacked documentation of wound measurements. e. Skilled nursing visit note, dated 11/10/23, lacked documentation of wounds. f. Skilled nursing visit note, dated 11/17/23, included documentation of left outer ankle wound, right outer ankle wound and left lateral below knee high calf burn but lacked documentation of wound measurements. g. Skilled nursing visit note, dated 11/24/23, included documentation of multiple wounds but lacked documentation of wound location or measurements. h. Wound Care Flow Sheet, dated 11/24/23, included documentation of: left below knee high calf wound scab, 6 centimeters (cm) x 1.5 cm; 2. right outer ankle wound 1.5 cm x 1.5 cm; 3. left outer ankle wound 1 cm x 1 cm; right sole area 3 cm x 2 cm; 4. multiple high hamstring low buttocks that lacked wound measurements and 5. multiple coccyx bone area that lacked wound measurements. The wound measurements for right outer ankle, left outer ankle and right sole area wounds lacked wound depth. i. Skilled nursing visit note, dated 12/1/23, included documentation of multiple wounds but lacked documentation of wound location or measurements. j. Wound Care Flow Sheet, dated 12/1/23, included documentation of left below knee high calf wound scab, 5 cm x 1.5 cm; right outer ankle wound 0.5 cm x 0.5 cm; left outer ankle wound 0.5 cm x 0.5 cm; right sole area 3 cm x 2 cm; multiple high hamstring low buttocks that lacked wound measurements and multiple coccyx bone area that lacked wound measurements. The wound measurements for right outer ankle, left outer ankle and right sole area wounds lacked wound depth. k. Skilled nursing visit note, dated 12/8/23, included documentation of multiple wounds but lacked documentation of wound location or measurements. l. Wound Care Flow Sheet, dated 12/8/23, included documentation of left below knee high calf wound scab, 4 cm x 1 cm; right outer ankle wound healed; left outer ankle wound healed; right sole area blister 3 cm x 2 cm; multiple high hamstring low buttocks 1 cm x 1 cm and multiple coccyx bone left of 3.5 cm x 2.5 cm x 1.5 cm. The wound measurements for multiple high hamstring low buttocks lacked wound depth. The nurse failed to obtain complete wound measurements weekly per agency policy. The agency provided no additional information prior to the end of the survey.”

“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 observations, agency staff interviews, record reviews, and policy review, the home health agency failed to ensure the drug regimen review identified at a minimum the effectiveness of drug therapy, drug side effects, actual or potential drug interactions, duplicate drug therapy, and/or patient compliance with medications for 7 of 8 sampled patients (Patients #1, #2, #3, #5, #6, #7 and #8). Failure to ensure medications reviewed at the time of each drug regimen review are current and accurate and failure to identify actual/ potential concerns increased the potential for unidentified medication interactions and side effect risks to the patient at the time of each comprehensive assessment. 6.Patient #1 had a start of care date of 2/23/21. Clinical record review revealed the following: a. Plans of Care, dated 4/8/24 to 6/6/24, 6/7/24 to 8/5/24 and 8/6/24 to 10/4/24, included medication orders for biofreeze gel and cool heat gel, pain medications. b. The Drug Regimen Review forms, dated 4/3/24, 6/3/24 and 8/5/24, identified no duplicate drug therapy. The drug regimen review failed to identify the duplicate pain medications. 7. Patient #7 had a start of care date of 8/30/23 and a discharge date of 12/15/23. Clinical record review revealed the following: a. The Plans of Care, dated 8/30/23 to 10/28/24 and 10/29/24 to 12/27/2023, included orders temazepam, zolpidem and trazodone (sleeping medications); escitalopram and mirtazapine (antidepressants); polyethylene glycol and fleet enema (bowel medications) and ben gay and lyrica (pain medications). b. The Drug Regimen Review forms, dated 8/30/23, 10/30/23 and 12/18/23, identified no duplicate drug therapy. The drug regimen review failed to identify the duplicate pain medications. The agency provided no additional information prior to the end of the survey. 4. Patient #5 had a start of care date of 7/10/24. Clinical record revealed the following: a. The POC, dated 7/10/24 to 9/7/24, included medication orders for Acetaminophen, Tylenol 8 hour and Hydrocodone (pain medications), Docusate sodium and Miralax (bowel medications), Calcium, Ferrous Sulfate, Vitamin B complex, Vitamin D and Vitamin D3 (supplements), Clopidogrel, Aspirin and Eliquis (coagulation agents) and Clonazepam, Quetiapine, Quviviq and Ropinirole (central nervous system agents). b. The Drug Regimen Review form, dated 7/10/24, identified no duplicate drug therapy. The agency failed to identify duplicate bowel medications, supplements, coagulation agents and central nervous system medications. 5. Patient #8 had a start of care date of 7/16/24. Clinical record revealed the following: a. The POC, dated 7/16/24 to 9/13/24, included medication orders for Acetaminophen and oxycodone (pain medications), Docusate sodium and Miralax (bowel medications), and Bupropion, Buspirone, Gabapentin, Hydroxyzine, Lamictal, Rexulti and Venlafaxine (central nervous system agents). b. The Drug Regimen Review form, dated 7/16/24, identified no duplicate drug therapy. The agency failed to identify duplicate bowel medications and central nervous system medications. 3. Patient #3 had a start of care date of 8/2/24. Clinical record revealed the following: a. The Plan of Care, dated 8/2/24 to 9/30/24, included medication orders for metoprolol succinate and valsartan (blood pressure medications); and protonix and famotidine (stomach acid reducers). b. The Drug Regimen Review form, dated 8/5/24, identified no duplicate drug therapy. Findings Include: According to the agency policy titled Medication Profile, dated January 2023, A drug regimen review will be performed at the time of admission, when updates to the comprehensive assessments are performed, when care is resumed after a patient has been placed on hold, and with the addition of a new medication. The review will be performed by qualified personnel and will identify drug/food interactions, potential adverse effects and drug reactions, ineffective drug therapy, duplicative drug therapy, and noncompliance with drug therapy. During agency staff interview on 8/12/24 at 1:00pm, Staff E, Registered Nurse, stated that she looks at the medication profile for any issues at admission, recertification and with any major changes with medications and let the physician know if there is any issues noted. 1. Patient #2 had a start of care date of 9/29/23. Clinical record review revealed the following: a. Plans of Care, dated 9/29/23 to 11/27/23, 11/28/23 to 1/26/24, 1/27/24 to 3/26/23, 3/27/24 to 5/25/24, and 5/26/24 to 7/24/24 included medication orders for Keppra, Tizanidine, Baclofen and Dantrolene sodium, (medications used to treat muscle spasms) b. The Drug Regimen Review forms, dated 9/29/23, 1/22/24, 5/23/24, 7/20/24 and 7/26/24, identified no duplicate drug therapy. The drug regimen review failed to identify the duplicate medications for muscle spasms. 2. Patient #6 had a start of care of 5/15/2019. Clinical record revealed the following. a. The plans of care dated,12/20/23 to 2/17/24, 2/18/24 to 4/17/24, 4/18/24 to 6/15/24 included medication orders for Atenolol, (blood pressure), Cetirizine, (antihistamine) , Sertraline (antidepressant) and Insulin (medication injected for diabetes control) b. The Drug Regimen Review forms dated, 12/18/23, 2/15/24, 3/14/24 and 5/3/24 identified no potential medication interactions. c. Patient #6 was discharged from the agency on 5/24/24, the clinical record lacked completion of a Drug Regimen Review at the time of discharge. The agency failed to complete the Drug Regimen Review at discharge and failed to identify potential medication interaction with the Drug Regimen Reviews completed in the clinical record.”

“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 home visit observations, patient interviews, clinical record reviews, and agency policy reviews, the agency failed to ensure the accurate completion of all components comprising the Plan of Care, including all supplies/equipment and medications used by the patient for 2 of 3 home visit observations (Patients #2 and #3). Failure to maintain complete and accurate Plans of Care with current orders placed the patients at risk to not receive services, medications, supplies, and/or treatments according to assessed needs and physician orders. Findings include: 2. Patient #2 had a start of care date of 9/29/23. Clinical review revealed the following. a. The Plan of Care (POC) dated, 9/29/23 to 11/27/23, included the following durable medical equipment (DME) used by the patient: a bedside commode, cane, dressing supplies, grab bars, hospital bed, respiratory equipment, slider board, tub/shower bench, wheelchair, diabetic supplies, dressing supplies and exam gloves. b. During a home visit observation on 8/12/24 at 12:20 PM, with Staff E, Registered Nurse (RN), the surveyor identified the following additional DME in the home: reacher. During this same visit, the patient was observed using the reacher throughout the visit and during a patient interview indicated he is not able to move his legs without using the reacher. The agency failed to include all of the DME required by the patient on the plan of care. The agency provided no additional information prior to the end of the survey. According to the agency policy titled Care Planning Process, dated January 2021, a written plan of care will be initiated within five days of the start of care and updated at least every 60 days or as patient’s condition warrants. The clinical plan of care includes but is not limited to the following: medications including dose/frequency/route, supplies and equipment required, frequency and duration of visits, prognosis, rehabilitation potential and nutritional requirements. 1.Patient #3 had a start of care date of 8/2/24. Clinical record review revealed the following: a. The Plan of Care (POC), dated 8/2/24 to 9/30/24 included the following medications: Voltaren Gel apply topical cream to painful area, Systane-solution one drop in each eye twice a day, Hydroxyzine 20 milligrams (mg) take one tablet twice a day as needed, Meclizine 25mg take one tablet two times a day as needed, Famotidine 20mg take one tablet at bedtime as needed, Ezetimibe 10mg take one tablet at bedtime, Furosemide 20mg take one tablet at 8:00 AM, Metformin 500mg take one tablet at 8:00 AM and 8:00 PM, Eliquis 5mg take one tablet at 8:00 AM and one tablet at 8:00 PM, Valsartan 80mg take one tablet at 8:00 PM, Protonix 40mg take one tablet at 8:00 AM, Metoprolol Succinate 50mg take one tablet at bedtime and Metoprolol Succinate 100mg take one tablet at 8:00 AM. b. During a home visit observation on 8/13/24 at 3:15 PM, with Staff F, Physical Therapy Assistant (PTA), an interview with the patient revealed the patient is taking Tylenol 500mg as needed, metamucil fiber gummies twice a day and Vitamin D3 50 micrograms (mcg) three tablets every morning. The surveyor observed the patient’s hydroxyzine was last refilled on 1/29/24 and the dose is 25mg with instructions to take one tablet by mouth three times a day. c. The POC included the following durable medical equipment (DME) used by the patient: Eye glasses, dentures, medtronic pacer, life alert, diabetic supplies, wheeled pushcart and grab bars. d. During a home visit observation on 8/13/24 at 3:15 PM, with Staff F, PTA, the surveyor identified the following additional DME in the home: blood pressure cuff. During this same visit, an interview with the patient revealed the blood pressure cuff has been utilized by the patient for a long time due to the patient’s fluctuating blood pressures. The POC failed to include correct medications and all DME the patient required for use.”

“Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This Element is not met as evidenced by: Based on agency staff interview, home visit observation, patient/ caregiver interview and admission packet review, the agency failed to provide agency patients with written medication schedule/instructions, including: medication name, dosage and frequency. The agency failed to provide this information for 1 of 3 sampled patients with home visits (Patient #3). The agency reported a census of 58 patients at the time of the survey. Failure to provide the medication schedule/instructions left the patients without the needed information to administer the correct dosage at the correct times and put the patient at risk for medication administration errors. Findings include: According to the agency policy titled Medication Profile, dated January 2021, each patient will receive appropriate written material for specific medications he/she is receiving. The material will contain information on actions of the medication, potential side effects, contraindications the patient should be aware of and any special instructions when taking the medication. Patient #3 had a start of care date of 8/2/24 and received skilled nursing, home health aide, physical therapy, and occupational therapy services from the agency. On 8/13/24 at 3:15 PM, during a home visit observation with Staff F, Physical Therapy Assistant (PTA), the patient revealed the patient did not have a current medication list in her home. The pharmacy fills the patient’s medication box and has a list taped to the bottom of the box that only included scheduled medications. The agency failed to provide the patient and caregiver with a copy of written instructions outlining the patient’s medication schedule and instructions. The findings were reviewed with the Administrator, Human Resource Manager, Corporate Liaison, Staff C, Nursing Supervisor and Staff D, Nursing Supervisor.”

“Treatments and therapy services CFR(s): 484.60(e)(3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services. This Element is not met as evidenced by: Based on agency staff interview, home visit observation, patient/ caregiver interview and admission packet review, the agency failed to provide agency patients with written information on any treatments to be administered by agency personnel acting on behalf of the agency, including therapy services. The agency failed to provide this information for 1 of 3 sampled patients with home visits (Patient #3). Failure to provide the patient with written information on treatments administered by the agency put the patient at risk for not receiving the ordered treatments including therapy services. Findings include: Patient #3 had a start of care date of 8/2/24 and received skilled nursing, home health aide, physical therapy, and occupational therapy services from the agency. On 8/13/24 at 3:15 PM, during a home visit observation with Staff F, Physical Therapy Assistant (PTA), Staff F performed her visit. The patient identified the only information provided by the agency was in the admission folder. Review of the admission folder revealed the patient was not given any written instructions outlining the treatments and therapy services being provided. The agency failed to ensure the patient had written instructions outlining the treatments and services being provided. The above findings were reviewed with the Administrator, Human Resource Manager, Corporate Liaison, Staff C, Nursing Supervisor and Staff D, Nursing Supervisor.”

“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 agency policy review, clinical record review, staff and patient interview, the agency failed to ensure home health aides provided care to agency patients only as ordered by the physician, permitted under state law and/or as directed by the skilled professional assigning the home health aide to the patient for 1 of 3 sampled patients receiving home health aide services (Patients #7). Failure to ensure that home health aide services are provided only as ordered by the physician, permitted under state law and/or as directed by the skilled professional assigning the home health aide to the patient and according to the home health aide care plan increased the risk that patients’ personal care needs were not adequately met. Findings include: Patient #7 had a start of care date of 8/30/23 and a discharge date of 12/15/23. Clinical record review revealed the following: a. The Plans of Care, dated 8/30/23 to 10/28/23 and 10/29/23 to 12/27/23, included physician orders for skilled nursing visits once a week and home health aide visits twice a week. b. The home health aide assignment, dated 8/31/23, directed the aides to assist the patient with personal care including shower, partial sponge bath, complete sponge bath, shampoo, lotion and passive range of motion. Instructions included patient is capable of making own decisions in regards to cares. c. The home health aide assignment, dated 10/30/24, directed the aides to assist the patient with personal care including shower, partial sponge bath, complete sponge bath, shampoo, lotion, passive range of motion, and standby assist in and out of shower. Instructions included patient is capable of making own decisions in regards to cares. d. The home health aide visit notes, dated 10/16/23 and 10/19/23, included documentation partial sponge bath was completed but lacked documentation regarding the tasks of shower, complete sponge bath and shampoo hair. e. The home health aide visit notes, dated 11/3/23, 11/7/23 and 11/14/23, included documentation partial sponge bath was completed but lacked documentation regarding the tasks of shower, complete sponge bath, shampoo hair and standby assist in and out of shower. f. The home health aide visit note, dated 11/10/23, included documentation shower and shampoo hair was completed but lacked documentation regarding the tasks of partial sponge bath, complete sponge bath and lotion. g. The home health aide visit note, dated 11/21/23, included documentation partial sponge bath was completed but lacked documentation regarding the tasks of shower, complete sponge bath, shampoo hair, lotion and standby assist in and out of shower. The home health aide failed to follow the aide care plan as directed or document why the care plan was not followed. The agency provided no additional information prior to the end of the survey. According to the agency policy titled Home Health Aide Plan of Care, dated 1/2021, the patient’s Case Manager, upon initialization of aide services, will develop the home health aide plan of care, consistent with the comprehensive plan of care and physician (or other authorized licensed independent practitioner) orders. The Case Manager or other appropriate clinician will supervise the home health aide at least every 14 days or every 60 days(depending on services of the client) to ensure care is provided according to plan. During an interview on 8/12/24 at 3:30 PM, Staff C, Nurse Supervisor stated the home health aide to notify the nurse if unable to complete a task. If a task requested not on the care plan, the aide to call the nurse so they can add the task to the care plan.”

“Required items in clinical record CFR(s): 484.110(a)(1) The patient’s current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This Element is not met as evidenced by: Based on agency policy review, clinical record review and staff interview, the agency failed to ensure the clinical record included the patient’s current documentation and a complete chart for 3 of 8 sampled patients (Patients #1, #5 and #8). Failure of the agency to ensure the clinical record included current documentation placed agency patients at risk to receive care or not receive care meeting the needs of the patient. Findings include: 3. Patient #1 had a start of care date of 2/23/21. Clinical record review revealed the following: a. The recertification comprehensive assessments, dated 6/3/24 and 8/5/24, were completed but lacked documentation of a drug regimen review. b. The document section of the electronic medical record lacked documentation of scanned drug regimen review forms for the dates of 6/3/24 and 8/5/24. During an interview on 8/13/24 at 9:30 AM, Staff B, Human Resource Manager, reported talking with Staff C, RN Supervisor, who was able to find the drug regimen review forms dated 6/3/24 and 8/5/24 in her email. Staff C unsure why the forms had not been uploaded into the electronic medical record. Paper copies of the forms were provided to the surveyor for review. The agency failed to upload all clinical documentation timely as required per agency expectation. The agency provided no additional information prior to the end of the survey. According to the agency policy titled Clinical/Service Data Collection, dated 1/2021, entries into the clinical/service record will be made on the day care/service is provided to the patient. All documentation will be turned into the office or electronically submitted within 72 hours of the date of the visit. Filing of visit must be done within 10 days from the date of the visit. 1. Patient #5 had a start of care date of 7/10/24. Clinical record review revealed the following: a. The start of care comprehensive assessment, dated 7/10/24, completed but lacked documentation of a drug regimen review. b. The document section of the electronic medical record lacked documentation of scanned drug regimen review forms for the dates of 7/10/24. During an interview on 8/13/24 at 9:30 AM, Staff B, Human Resource Manager, reported talking with Staff C, RN Supervisor, who was able to find the drug regimen review forms dated 8/13/24 in her email. Paper copies of the forms were provided to the surveyor for review. The agency failed to upload all clinical documentation timely as required per agency expectation. 2. Patient #8 had a start of care date of 7/16/24. Clinical record review revealed the following: a. The plan of care, dated 7/16/24 to 9/13/24, included orders for skilled nursing, physical therapy and occupational therapy. b. The document section of the electronic medical record lacked documentation of physical therapy or occupational therapy visit notes. c. During an interview on 8/13/24 at 1:20 PM, Staff B, Human Resource Manager, reported the agency office manager responsible to log into the contracted therapy system and upload the visit notes into the agency electronic medical record. She further stated the office manager failed to complete the task. The physical therapy and occupational therapy documents retrieved and handed to the surveyor for review. The agency failed to upload all clinical documentation timely as required per agency expectation.”