All Needs Senior Services

“Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient’s plan of care, for each patient’s medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This Condition is not met as evidenced by: Based on document review, and interview, the agency failed to ensure the Clinical Manager coordinated patient care (See G962). This deficient practice could negatively affect the health and safety of all 53 active agency patients, resulting in the potential for poor patient outcomes. The cumulative effect of these systemic problems resulted in the agency’s inability to ensure the provision of quality health care in a safe environment for the condition of participation of 42 CFR§484.105 Organization and Administration of Services.”

“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 record review and interview, the agency failed to ensure that 2 of 7 (P-1, 2) patients were included in their overall planning of care including informing the patient/caregiver in advance of discharge in which services would cease, resulting in a lack of inclusion in planning, lack of informed consent, and unmet care needs. Findings include: P-1: This 77-year-old was admitted to agency on 10/23/23 with diagnoses including Type 2 Diabetes and chronic pain. Upon entrance to the agency on 6/5/24, the agency provided a patient census report. P-1 was noted on the report to be discharged from agency services. The medical record was reviewed on 6/5/24. It was noted that a non-billable discharge visit was completed by the registered nurse (RN) on 5/24/24. In the discharge section “Care Summary”, the Skilled Nursing box was marked for discharge (Physical Therapy (PT) was an option but not marked). The RN discharge documentation under “Written notice of discharge provided to the patient” was left blank. An interview was conducted with P-1 on 6/6/24 at 1:22 p.m. During the interview, P-1 stated that she had not heard from the agency since the last PT visit which had been completed on 5/17/24. P-1 stated that she was aware that she would not have nursing visits as of 5/24/24 at her own request but was not discharged from the agency PT services. Interview was conducted on 6/6/24 at 10:57 a.m. with the Administrator (Staff A). Staff A was queried to whether P-1 was discharged on 5/24/24 from all agency services or just nursing services. Staff A stated that P-1 was discharged from all services on 5/24/24. Staff A was queried to whether P-1 received written information regarding the discharge and Staff A stated the Administrative Assistant, Staff E, sends discharge paperwork out to patients. On 6/6/24 at 1:35 p.m., interview was conducted with Staff E. Staff E was queried to whether discharge paperwork was sent to P-1 following the discharge visit by the RN on 5/24/24. Staff E stated that the discharge information still had not yet been sent to P-1 or the physician (13 days after the date of the discharge). The agency failed to involve the patient in discharge planning or notify the patient with at least 48 hours’ notice of discharge. **Agency Policy: “Discharge Process,” (Revised: 3/2/24). The policy states, “Procedure: The patient/caregiver will be involved in discharge planning activities and services will be coordinated with other care/service providers, if applicable. At least a 48-hour notice will be given unless there is imminent danger, and then discharge is completed as soon as possible.” P-2: The Start of Care (SOC) was dated 5/16/23. The Plan of Care (POC) identified diagnoses of Diabetes Type 2 and Congestive Heart Failure. During record review on 6/5/24, it was noted that the Registered Nurse (RN) completed a recertification on 5/8/24 with an ordered frequency of 1w9 (1 time a week for 9 weeks). The following week, the RN completed an OASIS-E Discharge (Non-Billable) on 5/17/24 stating, “Patient remains non-compliant with diet, medications and recommendations made by this agency for improvement. Patient and Dr notified discharge for non-compliance.” During an interview on 6/5/24 at 5 p.m., P-2 stated, “I received a text message on 5/16/24 that I was being discharged due to non-compliance. I received no notice, explanation, or anything regarding the discharge.” The agency failed to involve and inform the patient with at least an 48-hour notice of discharge.”

“Coordinate patient care CFR(s): 484.105(c)(2) Coordinating patient care, This Element is not met as evidenced by: Based on observation, record review and interview, the Practice Manager failed to ensure the coordination of patient care services for 6 of 7 (P-1, 2, 4, 5, 6, 7) records reviewed, resulting in a potential decline in physical functioning and resulting in the potential for the provision of care inconsistent with the plan of care and unmet care needs. Findings include: P-1: This 77-year-old was admitted to agency on 10/23/23 with diagnoses including Type 2 Diabetes and chronic pain. The medical record was reviewed on 6/5/24. During review, it was noted that a Physical Therapy (PT) evaluation visit was completed on 2/24/24 for the certification period of 2/20/24 through 4/19/24 with a frequency of 2 times per week for 8 weeks beginning 2/26/24. On the 4th week of service, the Physical Therapy Assistant (PTA) only made 1 visit (3/20/24). No other PT visits were made for the next 4 weeks of that certification period. There was a Communication Note dated 3/22/24 entered by the Practice Manager which stated, “Communication received that patient would like to wait until next episode to resume PT”. No other documentation could be found in the medical record which gave evidence for who communicated this. There were no PT notes which indicated that the patient wanted to wait until the next episode for PT services. There were no new physician orders discontinuing PT services. There was no evidence in the medical record that the physician was aware that the patient did not receive PT services between 3/20/24 and 4/20/24. A PT re-evaluation was completed by PT on 4/20/24 for the certification period of 4/20/24 through 6/18/24 with a frequency of 2 times per week for 7 weeks beginning on 4/22/24. The PTA completed only 3 of the 8 expected visits during the next 4 weeks (4/23/24 to 5/17/24). There was no documentation of why no other PT visits were made. There was no documentation of a PT discharge. The agency failed to coordinate patient care as ordered. P-4: This 73-year-old was admitted to the agency on 2/6/24 with diagnoses including Spinal Stenosis; heart failure; and Type 2 Diabetes. The medical record was reviewed on 6/6/24. The PT evaluation was completed on 2/10/24 and included orders for a frequency of 2 times per week for 5 weeks beginning 2/12/24. The PTA did not provide any visits for the first week of PT services and entered a “Missed Visit” form on 2/14/24 and 2/16/24 which both stated, “Therapist on Vacation” and both indicated that the physician was not made aware. There was only one visit made in the 4th week of service (3/3/24 to 3/9/24) and it was by the PT who completed a re-evaluation on 3/9/24. There was no explanation to why only one visit was made in the 4th week. The agency failed to coordinate patient care as ordered. The above findings were reviewed and acknowledged by Staff A during interview on 6/6/24 at 10:57 a.m. *Agency Policy: “Alternate Director of Nursing Job Description: Practice Manager”, (revised 6/5/24) stated, “…Participates in daily or weekly management team meetings to discuss client status census changes, personnel, or client complaints or concerns. Ensures delivery of compassionate quality care and nursing supervision as evidenced by adequate services and staff coverage of clients to maintain absence of odors, general cleanliness, prevention of pressure wounds, and apparent maintenance of optimal client functions… Coordinates nursing services with all other departments including Therapy.” Based on observation, record review and interview, the Practice Manager failed to ensure the coordination of patient care services for 6 of 7 (P-1, 2, 4, 5, 6, 7) records reviewed, resulting in a potential decline in physical functioning and resulting in the potential for the provision of care inconsistent with the plan of care and unmet care needs. Findings include: P-2: The Start of Care (SOC) was dated 5/16/23. The Plan of Care (POC) identified diagnoses of Diabetes Type 2 and Congestive Heart Failure. During record review on 6/5/24, it was noted that the Physical Therapy Assistant (PTA) documented 2 missed visits on 2/14/24 and 2/16/24 stating, “Therapist was on vacation.” Furthermore, on 3/8/24 the Registered Nurse (RN) completed a recertification visit and ordered RN 1w9 (1 visit a week for 9 weeks), PT (Physical Therapy) 1w9. On 3/15/24, the Practice Manager (Staff D) documented a “Patient Communication” that stated, “PT (Patient) denied PT (Physical Therapy) services this episode.” On 4/26/24 the RN documented, “P-2 said PT has still not come to evaluate him and scheduler notified who said she put P-2 on the schedule for next Saturday 5/4/24. Additionally, the RN documented on the 5/8/24 recertification, “P-2 will continue to benefit from nursing visits weekly and we also will order PT so patient can get evaluated for endurance and ambulation issues.” On 6/5/24 at 5 p.m., P-2 was questioned regarding a “Patient Communication” note that documented P-2 denying Physical Therapy (PT) services for the episode on 3/15/24. P-2 stated, “I never denied or refused any PT services, especially back in March (3/15/24). On Saturday, 5/4/24, I waited at home all day, and nobody showed up for my PT evaluation. The agency failed to coordinate patient care as ordered. P-5: The Start of Care (SOC) was dated 10/26/22. The Plan of Care (POC) identified diagnoses of Malignant Neoplasm of Lymphoid and Fibromyalgia. During record review on 6/5/24, it was noted that the PT completed an evaluation on 2/24/24 with an ordered visit frequency of 2w7 effective 2/26/24. The PTA completed the following visits: 2/28/24, 3/1/24, 3/5/24, 3/7/24, 3/12/24, 3/15/24 and 3/21/24. There were no completed PT/PTA visits after 3/21/24, thus the agency failed to complete 7 visits as ordered. Additionally, the RN completed a recertification on 4/18/24 and ordered PT to “Eval and Treat.” On 4/27/24, the PT completed an evaluation with an ordered visit frequency of 2w6 effective 4/29/24. The PTA completed the following visits: 4/30/24, 5/3/24, 5/7/24, 5/8/24, 5/15/24 and 5/16/24. There were no completed PT/PTA visits after 5/16/24, thus the agency failed to complete 5 visits as ordered. The EMR (Electronic Medical Record) contained two scheduled visits stating, “PT Re-evaluation w/Supervisory Visit” that are “Not Started” with a note stating, “PT not available. PT (Patient) aware. Will reschedule.” The RN completed a discharge on 6/3/24 stating, “pt (patient) changed homecare agency.” The agency failed to coordinate patient care as ordered. P-6: The Start of Care (SOC) was dated 6/5/23. The Plan of Care (POC) identified diagnoses of Spinal Stenosis, Low Back Pain and Spondylolysis. During record review on 6/5/24, it was noted that the PT completed an evaluation on 12/9/23 with an ordered frequency of 3w6. The PTA completed a visit on 12/13/23. The PTA documented a “Missed Visit” on 12/20/23 stating, “No answer to phone call.” The PTA documented a “Missed Visit” on 12/22/23 stating, “Therapist unable to schedule pt (patient) for visit this week.” The PTA documented a “Missed Visit” on 12/27/24 and 12/29/24 stating, “Therapist unavailable.” The PTA documented a “Missed Visit” on 1/3/24 stating, “Therapist unable to see pt (patient) this week.” The PTA documented a “Missed Visit” on 1/10/24 stating, “Pt (Patient is due for 30 day reassessment.” The PTA documented a “Missed Visit” on 1/12/24 stating, “Pt (Patient) is due for reassessment.” The PT documented a “Missed Visit (PT Re-evaluation w/Supervisory Visit) on 1/13/24 stating, “No answer to phone call.” The PTA documented a “Missed Visit” on 1/17/24 and 1/19/24 stating, “Pt (Patient) is due for reassessment.” The PTA documented a “Missed Visit” on 1/26/24 stating, “Therapy on hold.” The PTA documented a “Missed Visit” on 1/31/24 and 2/2/24 stating, “Pt (Patient) is due for reassessment.” 2 of 18 ordered PT visits were completed. The agency failed to coordinate patient care as ordered. P-7: The Start of Care (SOC) was dated 4/7/23. The Plan of Care (POC) identified diagnoses of Dysphagia, Cerebrovascular Accident and Hypertension. During record review on 6/28/23, the PT completed an evaluation on 4/13/24 with an ordered frequency of 2w8 effective 4/17/24.The PTA completed visits on 4/17/24, 4/19/24, 4/24/24, 4/26/24, 4/30/24, 5/2/24 and 5/8/24. On 5/18/24 the PT completed a “Missed Visit (PT Re-evaluation w/Supervisory Visit)” stating, “PT (Physical Therapist) unable to recert due to health concerns.” No further PT/PTA documentation was noted. During an observation visit with a LPN (Licensed Practical Nurse) on 6/6/24, the patient was questioned regarding PT visits and stated, “I have not seen or heard from therapy recently.” The agency failed to coordinate patient care as ordered. These findings were reviewed with and acknowledged by the Staff A (Administrator) during an interview on 6/6/24 at 1:15 pm.”

“Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient’s eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This Condition is not met as evidenced by: Based on record review, and interview, it was determined the agency (HHA) failed to ensure the Registered Nurse conducted the initial assessment visit within 48 hours of referral for 1 record reviewed (P-2), see (G-514), failed to conduct a patient-specific, comprehensive assessment that accurately reflected the patient’s current health status with baseline data for future assessments, in 2 of 7 records reviewed (P-2, 6), see (G-526), failed to notify the physician of potential major drug interactions resulting from the combination of medications the patient was prescribed in 4 of 7 records reviewed (P-1,2,3,4), see (G-536), from a total sample of 7 records reviewed. The cumulative effects of this systemic problem resulted in the Home Health Agency’s inability to ensure the provision of quality health care in a safe environment for the condition of participation of 42 CFR 484.55 Comprehensive Assessment.”

“Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient’s medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This Condition is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care included measurable goals for 3 of 7 records reviewed, (P-5, 6, 7) see (G-572), failed to include interventions, parameters, and safety precautions in 3 of 7 records reviewed (P-5, 6, 7) see (G-574), failed to ensure the frequency of visits ordered were followed in 1 of 7 records reviewed (P-5) see (G-578), and failed to ensure the physician was notified of changes in care for 2 of 7 records reviewed (P-5, 7), see (G-590), from a total of 7 records reviewed. The cumulative effect of these systemic problems resulted in the home health agency’s inability to ensure the provision of quality health care for the condition of participation of 42 CFR 484.60: Care Planning, Coordination of Services, and Quality of Care.”

“Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA’s governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA’s performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This Condition is not met as evidenced by: Based on document review and interview, the agency’s QAPI Program failed to include evidence of measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care (refer to G-642); and failed to provide evidence of Governing Body approval of the agency’s Quality Assessment and Performance Improvement Program for 2023 or 2024 (G-660). Findings include: The cumulative effects of this systemic problem resulted in the Home Health Agency’s inability to ensure the provision of quality health care in a safe environment for the condition of participation of 42 CFR 484.65: Quality Assessment and Performance Improvement.”

“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 conduct exercises to annually test the emergency plan or provide documentation of an actual event that would qualify as a test of the emergency plan; failed to conduct an additional full-scale exercise or a table-top exercise; and failed to analyze the agency’s response to and maintain documentation of all drills, tabletop exercises, emergency events and revise the emergency plan as needed. This deficient practice could affect the health and safety of all agency patients in the event of a facility emergency or disaster. Findings include: On 1/8/2024, the agency’s emergency preparedness documentation was reviewed. Record review indicated there was no documentation of a full-scale exercise or a table-top exercise for 2020, 2021, 2022, or 2023. There was no documentation of the following: an actual event that would qualify as a test of the emergency plan, an additional full-scale exercise or a table-top exercise, and an analysis of the agency’s response to all drills, tabletop exercises, emergency events and revisions to the emergency plan as needed. The findings were acknowledged during an interview on 1/8/24 at 1:30 p.m. with the administrator (ADM-1).”

“Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient’s status, and must include, at a minimum, the following information: This Standard is not met as evidenced by: Based on record review and interview, the agency failed to conduct a patient-specific, comprehensive assessment that accurately reflected the patient’s current health status with baseline data for future assessments, in 2 of 7 records reviewed (P-6, 2) out of a total of 7 records reviewed, resulting in the potential for unmet care needs, and negative patient outcomes. Findings included: P-6: The start of care (SOC) was dated 10/10/22. The plan of care (POC) identified diagnoses of heart failure and pulmonary edema. Upon review of the comprehensive assessment on 2/6/24, it was noted that the registered nurse (RN) failed to obtain objective data for future assessments to measure the patient’s specific status. For example, the RN failed to document a baseline blood sugar for a diabetic patient, and a baseline weight for heart failure. The findings were reviewed with and acknowledged by the administrator (ADM-1) during an interview on 2/8/24 at 1:30 p.m. P-2: The Start of Care (SOC) was dated 1/20/2023. The Plan of Care (POC) identified diagnoses of Diabetes Type 2 (DM2), and Disruption of external operation (surgical) wound, and Necrotizing Enterocolitis (NEC). Upon review of the comprehensive assessment on 2/6/24, it was noted that the registered nurse (RN) failed to obtain objective data for future assessments to measure the patient’s specific status. For example, the RN failed to document a baseline blood sugar for a diabetic patient, and a baseline measurements of the patients disrupted external surgical wound. These findings were reviewed and acknowledged with the Administrator (ADM-1) and Director of Nursing (DON-2) during an interview at 1:00 p.m. on 2/8/24.”

“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 develop a plan of care that included patient-specific measurable outcomes and goals to use in determining the patient’s progress towards obtaining goals in 7 (P-1,2,3,4, 5, 6, 7) of a total of 7 records reviewed, resulting in the agency and patient being unable to ascertain if goals are met. Findings included: P-5: The start of care (SOC) was dated 7/8/23. The plan of care (POC) identified diagnoses of diabetes mellitus, chronic obstructive pulmonary disease, and bipolar. Record review on 2/5/24, showed the POC ordered Skilled Nursing (SN), Physical therapy (PT), and Medical Social Work (MSW) services to be provided. During review of the POC, it was discovered that the SN goals were not measurable. One goal stated, “The patient’s pulse will remain within established parameters during the episode.” Another stated, “Patient will maintain diabetic diet compliance during the episode.” P-6: The SOC was dated 10/10/22. The POC identified diagnoses of heart failure and pulmonary edema. Record review on 2/6/24, showed the POC dated 12/4/23, ordered SN, PT, and home health aide (HHa) services to be provided. During review of the POC, it was discovered that the SN goals were not measurable. One goal stated, “The patient will maintain consistent carbs/no concentrated sweets, low sodium diet compliance during the episode.” Another stated, “Patient’s blood pressure will remain within established parameters during the episode.” P-7: The SOC was dated 10/23/23. The POC identified diagnoses of diabetes mellitus, heart failure and depression. Record review on 2/7/24, showed the POC dated 12/22/23, ordered SN and PT services to be provided. During review of the POC, it was discovered that the SN goals were not measurable. One goal stated, “The patient will maintain blood sugars [sic] diet compliance during the episode.” Another stated, “Patient will verbalize proper use of pain medication by [sic].” There was no evidence of how the goals could be objectively measured to ascertain progress toward goals. The findings were reviewed with and acknowledged by the administrator (ADM-1) during an interview on 2/8/24 at 1:30 p.m. P-1: This patient was admitted on 3/3/23. The Plan of Care (POC) for the certification period 12/28/2023 to 2/25/2024 identified a primary diagnosis of Cerebral Infarction due to unspecified occlusion of cerebral artery, and secondary diagnoses of unspecified fall, essential hypertension, and overactive bladder. Upon review of the patient’s medical record, 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 maintain heart healthy diet compliance during the episode; Home exercise program will be established by physical therapist; Patient’s ADL/IADL needs will be met with assistance of home health aide.” These goals are not objectively measurable to determine the patient’s progress towards obtaining the goals. P-2: The Start of Care (SOC) was dated 1/20/2023. The Plan of Care (POC) identified diagnoses of Diabetes Type 2 (DM2), and Disruption of external operation (surgical) wound, and Necrotizing Enterocolitis (NEC). Upon review of the record, it was noted the goals on the POC were not objectively measurable. Examples include: “Home exercise program will be established by physical therapist; Patient will maintain Diabetic Diet compliance during the episode; These goals are not objectively measurable to determine the patient’s progress towards achieving the goals. P-3: The SOC was dated 5/16/2023. The POC for the certification period 1/11/24 to 3/10/24 identified diagnoses of Congestive Heart Failure (CHF) and Diabetes Type 2 (DM2). Upon review of the POC it was noted the goals were not objectively measurable to determine the patient’s progress towards obtaining the goals. Examples included: “Patient will verbalize an understanding of skin conditions that must be reported to the Skilled Nurse or physician immediately; Patient had recent appointment with cardiology and denies changes or any new orders; Home exercise program will be established by physical therapist. These goals are not objectively measurable or specific to the patient’s needs to determine the patient’s progress towards achieving the goals. P-4: The SOC was dated 1/29/2024. The POC for the certification period 1/29/24 to 3/28/24 identified diagnoses of Chronic Obstructive Pulmonary Disease (COPD) and Congestive Heart Failure (CHF). Upon review of the POC it was noted the goals were not objectively measurable to determine the patient’s progress towards obtaining the goals. Examples included: “Home Exercise Program will be established by physical therapist.” This goal is not individualized or measurable to meet the patient’s individualized needs. These findings were reviewed and acknowledged with the Administrator (ADM-1) and Director of Nursing (DON-2) during an interview at 1:00 p.m. on 2/8/24.”

“Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This Standard is not met as evidenced by: Based on record review and interview, it was determined the Home Health Agency (HHA) failed to ensure the frequency of visits ordered on the Plan of Care (POC) were followed in 1 of 7 (P-5) records reviewed, from a total sample of 7 records reviewed, resulting in the potential for unmet patient needs. Findings include: P-5: The SOC was dated 7/8/23. The POC identified the diagnoses of diabetes mellitus, chronic obstructive pulmonary disease, and bipolar. Skilled nursing services were ordered at a visit frequency of 1W1 and 1W9. During record review on 2/5/24, it was found that 4 missed visits were documented in the record. There was no documented evidence in the record of any attempt to make up the missed visits. During an interview on 2/8/24 at 1:30 p.m., the administrator (ADM-1) acknowledged the above findings.”

“Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This Standard is not met as evidenced by: Based on document review and interview, the agency’s QAPI Program failed to include evidence of measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. Findings included: Upon entering the agency on 2/5/24, without requesting, the Administrator provided this surveyor with a 9-page document titled “QAPI 2023 All Needs Senior Services.” It was noted the Key measures for 2023 were: “Infection Control; Safety, Quality, Patient Outcomes and Agency Performance; Major Improvement Opportunity.” This surveyor asked for the Administrator to provide the collected data before and at the close of these QAPI Projects. The data collections were not provided before the close of the survey.” Upon review of the provided documents the following information was obtained for Infection Control: 1) The agency was using key result areas for the Pandemic Event and Vaccinations with key result measures to ensure standard precautions were used at each visit, including compliance, isolation, covid protocols, infection control and monitoring. However, Covid-19 was not a major health issue for 2023, and the request to provide the data collected was never provided. 2) For Safety and Quality: a) Fall Risk: the agency monitored charts performed on a continual basis to insure {sic} compliance of reporting falls and follow-up. A fall risk was assessed at SOC and recertifications. For those patients with a known fall risk, nursing assessment and education was done at each visit {sic}. b) Complete Orders: based on chart reviews to insure {sic} current order was being used and was completed. c) License compliance: verification of orders being completed with respect to license requirements as deemed by state and federal law for Home-Health aides, Physical Therapists, Occupational Therapists, Registered Nurses, Licensed Practical Nurses, Certified Nursing Aides. However, there was no data collection provided to this surveyor to understand the results of the agency’s Safety and Quality. 3) Patient Outcomes and Agency Performance: Patient Outcomes and Agency Performance was based on complaints, satisfaction surveys, supervisory visits, and Chart Audits. The results, 100% compliance for chart audits, however, no evidence or data provided for the surveyors to review. a) Complaints were monitored and addressed when received and the outcome was determined that the major complaint for 2023 was office communication. New software and staff instructions was used to improve communication with staff. However, there was no data provided to the surveyor for review. b) Satisfaction Surveys were done throughout the year with a result of patient’s dissatisfied with arrival time of staff. No data was provided for review. c) Supervisory Visits were completed with a review of charts to ensure supervisory visits were completed by the supervising nurse resulting in 100% compliance, however no data was provided for this surveyor to review. d) Adequate Staffing through chart audits to ensure appropriate mix of staff was available to service clients with outcome result of a shortage of nurse aides, however, no data was provided to confirm the results. These findings were reviewed and acknowledged with the Administrator (ADM-1) and Director of Nursing (DON-2) during an interview at 1:00 p.m. on 2/8/24.”

“Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA’s governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to provide evidence of Governing Body approval of the agency’s Quality Assessment and Performance Improvement Program for 2023 or 2024. Findings included: On 2/7/2024 at 10:00 a.m., the Administrator (ADM#1) was asked to provide the Governing Body Meeting Minutes for 2023. The Governing Body Minutes were not provided by the end of the day on 2/7/2024. The Administrator was again asked to provide a copy of the Governing Body Meeting Minutes for 2023 at 9:30 am on 2/8/2024. ADM-1 again failed to provide a copy of the Governing Body Meeting Minutes. At 11:00 am the Director of Nursing (DON-2) was asked if she was able to provide the agency’s governing body minutes for review, however she did not provide the documents as requested. Due to the agency failing to provide Governing Body minutes for the year 2023 or 2024, there was no documentation or evidence that the Governing Body had approved the agency’s Quality Assessment and Performance Improvement Program for the years 2023 or 2024.”

“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, and interview, the agency failed to follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases while providing nursing services to a patient during a home visit in 1 of 3 survey home visits (P-1) provided within the home of an active patient. Findings included: P-1: The Start of Care was dated 3/3/2023. The Plan of Care for the certification period 12/28/23 to 2/25/2024 identified diagnoses of Cerebral Infarction, unspecified fall, essential hypertension, and overactive bladder. During a survey home visit with the registered nurse (RN#5), RN#5 was observed placing her bag of equipment on a chair without a barrier between the chair and bag. RN#5 then proceeded to remove medical equipment (stethoscope, pulse oximeter, and thermometer) from the bag and directly onto the chair without a barrier. RN#5 then placed her computer directly on the couch without a barrier. After evaluating the patient and performing vital signs, RN#5 stated, “I forgot to bring my alcohol” and then asked the patient if she “had any alcohol she could use.” The patient instructed RN#5 where she could find her bottle of alcohol. RN#5 grabbed the contaminated bottle of alcohol while wearing the same gloves used to evaluate the patient and then proceeded to wipe her equipment with a paper towel sprayed with the patient’s alcohol and placed her equipment in the bag wearing the same contaminated gloves. The equipment bag and computer remained laying directly on the chair and couch respectively. RN#5 charted the visit on the computer and then placed the computer in the bag without wiping the computer with alcohol, thus contaminating all items within the bag. After leaving the patient’s home, RN#5 was advised about her lack of using standard precautions with equipment used on the patient and placing a contaminated computer in the bag with contaminated equipment after evaluating the patient. These findings were reviewed and acknowledged by RN#5 after the visit and also acknowledged by the Administrator (ADM-1) and Director of Nursing (DON-2) during an interview on 2/6/2024 at 11:00 a.m.”

“Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This Standard is not met as evidenced by: Based on record review and interview, the agency failed to include the frequency and duration of visits on the Aide Care Plan for 1 of 1 (P-4) records that included Home Health Aide Services. Findings included: P-4: The SOC was dated 1/29/2024. The Plan of Care for the certification Period 1/29/2024 to 3/28/2024 identified diagnoses of Chronic Obstructive Pulmonary Disease with Acute Exacerbations (COPD) and Chronic Systolic (congestive) Heart Failure (CHF). Upon review of the record, it was noted an order for the agency to provide Home Health aide services. Upon reviewing the Aide Care Plan, it was noted the Registered Nurse (RN#5) failed to include a frequency and duration for Aide visits to be provided to the patient. These findings were reviewed and acknowledged with the Administrator (ADM-1) and Director of Nursing (DON-2) during an interview at 2:30 p.m. on 2/8/24.”

“Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to include a signed plan of care in the record for 6 of 7 (P-1, 2, 3, 4, 5, 6) records reviewed, from a total of 7 records reviewed, resulting in the potential for unmet care needs. Findings include: P-5: The start of care (SOC) was dated 7/8/23. The plan of care (POC) identified diagnoses of diabetes mellitus, chronic obstructive pulmonary disease, and bipolar. During record review on 2/5/24, it was discovered that skilled nursing (SN), physical therapy (PT), and medical social work (MSW) services were ordered. During review of the POC, it was discovered that the POC was not signed by the physician. P-6: The start of care (SOC) was dated 10/10/22. The plan of care (POC) identified diagnoses of heart failure and pulmonary edema. Record review on 2/6/24, showed the POC dated 12/4/23, ordered SN, PT and home health aide (HHa) services. During review of the POC, it was discovered that the POC was not signed by the physician. The findings were reviewed with and acknowledged by the administrator (ADM-1) during an interview on 2/8/24 at 1:30 p.m. P-1: This patient was admitted on 3/3/23. The Plan of Care (POC) for the certification period 12/28/2023 to 2/25/2024 identified a primary diagnosis of Cerebral Infarction due to unspecified occlusion of cerebral artery, and secondary diagnoses of unspecified fall, essential hypertension, and overactive bladder. The patient was receiving Skilled Nursing and Physical Therapy Services. During review of the POC, it was noted that the POC was not signed by the physician. P-2: The Patient was admitted on 1/20/2023. The POC for the certification period 1/20/23 to 3/20/23 identified diagnoses of Diabetes type 2 (DM2) and Necrotizing Enterocolitis (NEC). The patient was receiving Skilled Nursing and Physical Therapy Services. During a review of the Plan of Care (POC), the POC was not signed by the physician. P-3: The SOC was dated 5/16/2023. The POC for the certification period 1/11/24 to 3/10/24 identified diagnoses of Congestive Heart Failure (CHF) and Diabetes Type 2 (DM2). A review of the patient’s medical record revealed the patient was receiving skilled nursing and physical therapy services. During a review of the patient’s Plan of Care, it was noted the POC was not signed by the physician. P-4: The SOC was dated 1/29/2024. The Plan of Care for the certification Period 1/29/2024 to 3/28/2024 identified diagnoses of Chronic Obstructive Pulmonary Disease with Acute Exacerbations (COPD) and Chronic Systolic (congestive) Heart Failure (CHF). The patient was receiving Skilled Nursing and Physical Therapy Services. Upon review of the Plan of Care, it was noted the POC was not signed by the physician. These findings were reviewed and acknowledged with the Administrator (ADM-1) and Director of Nursing (DON-2) during an interview at 1:00 p.m. on 2/8/24.”

“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 ensure the Registered Nurse conducted the initial assessment visit within 48 hours of referral, to determine the immediate care needs of the patient, including homebound status for 1 (P-2) record in which Skilled Nursing services were needed, from a total of 7 records reviewed, resulting in delay in needed care and services and the potential for unmet care needs. Findings include: P-2: The Patient was admitted to the Home Health agency on 1/20/2023. The POC for the certification period 1/20/23 to 3/20/23 identified diagnoses of Diabetes type 2 (DM2) and Necrotizing Enterocolitis (NEC). Upon review of the record, it was noted the patient was discharged from an inpatient hospital stay on 1/6/2023, the referral was dated 1/10/2023, and the Start of Care Assessment conducted by the registered nurse was dated 1/20/23, 10 days after the referral. There was no documentation or physician orders found in the record that indicated a need for a delay in the Start of Care Assessment. The agency failed to conduct the Start of Care Assessment within 48 hours of the patient’s return home. These findings were reviewed and acknowledged with the Administrator (ADM-1) and Director of Nursing (DON-2) during an interview at 1:00 p.m. on 2/8/24.”

“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 notify the physician of potential major drug interactions resulting from the combination of medications the patient was prescribed in 4 of 7 (P-1,2,3,4) records reviewed. These potential major drug interactions could result in further health problems for the patient using these combined medications. P-1: This patient was admitted on 3/3/23. The Plan of Care (POC) for the certification period 12/28/2023 to 2/25/2024 identified a primary diagnosis of Cerebral Infarction due to unspecified occlusion of cerebral artery, and secondary diagnoses of unspecified fall, essential hypertension, and overactive bladder. Upon review of the patient’s medical record, it was noted the following identification of major drug interactions with the patient’s current prescribed medications. The concurrent use of Naproxen and Warfarin may cause the patient to bleed easily. Upon review of the record, there was no documentation that the agency had notified the physician or was performing International Normalized Ratios (INR) to determine if the patient’s prothrombin time results would put her at risk for excessive bleeding. The concurrent use of Warfarin and Aspirin may also result in the patient to easily bleed based on INR results. The concurrent use of Calcium 600-D and Vitamin D3. The concurrent use of these two drugs, both forms of Vitamin D, can lead to toxic effects related to excessive calcium levels in the blood and urine such as irregular heart rhythm, seizures, kidney stones, and eventual calcification of blood vessels, cornea, and soft tissues of the body. There was no indication found in the record that these interactions had been reported to the physician. P-2: The Patient was admitted on 1/20/2023. The POC for the certification period 1/20/23 to 3/20/23 identified diagnoses of Diabetes type 2 (DM2) and Necrotizing Enterocolitis (NEC). Upon review of the patient’s medical record, it was noted the following identification of major drug interactions with the patient’s current prescribed medications: 1. The concurrent use of Hydrocodone together with Cyclobenzaprine can lead to serious side effects including respiratory distress, coma, and even death. 2. The concurrent use of Hydrocodone together with Gabapentin can lead to serious side effects including respiratory distress, coma, and even death. 3. The concurrent use of Hydrocodone together with Quetiapine can lead to serious side effects including respiratory distress, coma, and even death. The Skilled Nurse had documented “no issues found,” in the comprehensive assessment under medication review. There was no indication found in the record that these interactions had been reported to the physician. P-3: The SOC was dated 5/16/2023. The POC for the certification period 1/11/24 to 3/10/24 identified diagnoses of Congestive Heart Failure (CHF) and Diabetes Type 2 (DM2). Upon review of the patient’s medical record, it was noted the following identification of major drug interactions with the patient’s current prescribed medications: 1. The concurrent use of Clopidogrel together with Rosuvastatin may increase the blood levels of Rosuvastatin which can result in side effects such as liver damage and a rare condition called rhabdomyolysis that involves the breakdown of skeletal muscle tissue. Rhabdomyolysis can also cause kidney damage and even death. There was no indication found in the record that this major interaction had been reported to the physician. P-4: The SOC was dated 1/29/2024. The Plan of Care for the certification Period 1/29/2024 to 3/28/2024 identified diagnoses of Chronic Obstructive Pulmonary Disease with Acute Exacerbations (COPD) and Chronic Systolic (congestive) Heart Failure (CHF). Upon review of the Plan of Care under the category of treatments, it was noted there were no medications listed. The agency failed to include a list of the patient’s current medications on the patient’s Plan of Care for review. These findings were reviewed and acknowledged with the Administrator (ADM-1) and Director of Nursing (DON-2) during an interview at 1:00 p.m. on 2/8/24.”

“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 Plan of Care failed to include interventions to address the patients Congestive Heart Failure (CHF) in 4 of 7 patients (P-3, 4, 6, 7), failed to include interventions for 3 of 4 patients (P-2, 3 and 7) diagnosed with Type 2 Diabetes (DM2), failed to include weight parameters in 2 of 7 patients (P-6, 7) diagnosed with CHF, and failed to include bleeding/anticoagulant precautions in 1 of 7 patients (P-7) on a blood thinner, from a total of 7 records reviewed, resulting in the potential for negative patient outcomes. Findings included: P-6: The start of care (SOC) was dated 10/10/22. The plan of care (POC) identified diagnoses of heart failure and pulmonary edema. Record review on 2/6/24, showed the POC dated 12/4/23, ordered skilled nursing (SN) and physical therapy (PT) services. During review of the POC, it was discovered that no reportable weight parameters were documented for when to contact the physician, with a diagnosis of heart failure. P-7: The SOC was dated 10/23/23. The POC identified diagnoses of diabetes mellitus, heart failure and depression. Record review on 2/7/24, showed the POC dated 12/22/23, ordered SN and PT services to be provided. During review of the POC, it was discovered that no reportable weight parameters were documented for when to contact the physician, with a diagnosis of heart failure. No bleeding/anticoagulant precautions were documented with the patient taking Xarelto, and no diabetic precautions were documented with a diagnosis of diabetes. The findings were reviewed with and acknowledged by the administrator (ADM-1) during an interview on 2/8/24 at 1:30 p.m. P-2: The Patient was admitted on 1/20/2023. The POC for the certification period 1/20/23 to 3/20/23 identified diagnoses of Diabetes type 2 (DM2) and Necrotizing Enterocolitis (NEC). Upon review of the record, it was noted the POC did not include orders for reportable parameters for blood sugar results to report to the physician, nor did the plan of care include orders on the frequency of blood sugar testing each day. P-3: The SOC was dated 5/16/2023. The POC for the certification period 1/11/24 to 3/10/24 identified diagnoses of Congestive Heart Failure (CHF) and Diabetes Type 2 (DM2). Upon review of the record, it was noted there were no physician orders to weigh patient daily to monitor the patient’s CHF. In addition, there were no physician orders for reportable parameters for weight gain to address the patient’s CHF. Also, there were orders for reportable parameters to address the patient’s DM2, however there were no orders for the frequency of blood sugar monitoring, nor were there orders for a “sharps container” to safely dispose of needles for insulin injection and blood sugar testing under the category of DME & Supplies. P-4: The SOC was dated 1/29/2024. The POC for the certification period 1/29/24 to 3/28/24 identified diagnoses of Chronic Obstructive Pulmonary Disease (COPD) and Congestive Heart Failure (CHF). Upon review of the Plan of Care, there were no orders to weight the patient daily, nor any order for reportable parameters of weight gain to report to the physician.”

“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 ensure the physician was notified of changes in care ordered in the plan of care (POC) for 2 of 7 (MR# 5, 7) records reviewed, resulting in the potential for physical decline and negative patient outcomes. Findings include: P-5: The SOC was dated 7/8/23. The POC identified diagnoses of diabetes mellitus, chronic obstructive pulmonary disease, and bipolar. During record review on 2/5/24, it was discovered that PT and MSW services were ordered at an initial frequency of 1w1. No visits from PT or MSW were documented in the record. There was no documentation to indicate the patient had declined PT and MSW visits and no documentation that the physician was informed that PT and MSW services were not provided. P-7: The SOC was dated 10/23/23. The POC identified diagnoses of diabetes mellitus, heart failure and depression. Record review on 2/7/24, showed the POC dated 12/22/23, ordered PT services to be provided at a visit frequency of 3w6 starting on 12/22/23. During review of the record, it was discovered that the PT did not make their initial visit until 1/20/24, 29 days after ordered. There was no documented evidence in the record that the physician was notified of the late start of care. The findings were reviewed with and acknowledged by the administrator (ADM-1) during an interview on 2/8/24 at 1:30 p.m.”

“Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure physical therapy (PT), medical social worker (MSW), and Home Health Aide (HHa) services were provided as ordered by the physician in the plan of care for 2 of 7 (P-5, P-1) records reviewed, resulting in the potential for physical decline and negative patient outcomes. Findings include: P-5: The start of care (SOC) was dated 7/8/23. The plan of care (POC) identified diagnoses of diabetes mellitus, chronic obstructive pulmonary disease, and bipolar. During record review on 2/5/24, it was discovered that PT and MSW services were ordered at an initial frequency of 1w1. No visits from PT or MSW were documented in the record. There was no documentation in the record to indicate the patient had declined PT and MSW visits, and no documentation that the physician was informed that PT and MSW services were not provided. The findings were reviewed with and acknowledged by the administrator (ADM-1) during an interview on 2/8/24 at 1:30 p.m. P-1: This patient was admitted on 3/3/23. The Plan of Care (POC) for the certification period 12/28/2023 to 2/25/2024 identified a primary diagnosis of Cerebral Infarction due to unspecified occlusion of cerebral artery, and secondary diagnoses of unspecified fall, essential hypertension, and overactive bladder. The Plan of Care included orders for Skilled Nursing (SN), Physical Therapy (PT), and Home Health aide (HHa) Services. Upon review of the record, it was noted that no home health aide visits had been provided, nor was there a physician order in the chart to discontinue home health aide services. These findings were reviewed and acknowledged with the Administrator (ADM-1) and Director of Nursing (DON-2) during an interview at 1:00 p.m. on 2/8/24.”

“Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This Element is not met as evidenced by: Based on record review and interview, the agency failed to document patient information in the clinical notes in 2 of 7 (P-6 and 7) records reviewed, resulting in inaccurate or misunderstood communication in patient healthcare clinical records, and the potential for negative patient outcomes. Findings included: P-6: The start of care (SOC) was dated 10/10/22. The plan of care (POC) identified diagnoses of heart failure and pulmonary edema. Record review on 2/6/24, showed the POC dated 12/4/23, ordered skilled nursing (SN) at a visit frequency of 1w1 and 2w9, physical therapy (PT) visits were ordered at a frequency of 1w1, and home health aide (HHa) services were ordered at a frequency of 2w9. During review of the record, it was discovered that no weights were documented on the SN visit notes for any of the 19 (SN) visits, with a diagnosis of heart failure. P-7: The SOC was dated 10/23/23. The POC identified diagnoses of diabetes mellitus, heart failure and depression. Record review on 2/7/24, showed the POC dated 12/22/23, ordered SN at a visit frequency of 1w9, and PT services at a visit frequency of 3w6. During review of the record, it was discovered that no weights were documented on the SN visit notes for any of the 6 (SN) visits provided, with a diagnosis of heart failure. The findings were reviewed with and acknowledged by the administrator (ADM-1) during an interview on 2/8/24 at 1:30 p.m.”

“Required items in clinical record CFR(s): 484.110(a)(1) The patient’s current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This Element is not met as evidenced by: Based on record review and interview, the agency failed to include clinical visit notes for skilled nursing in 1 of 7 (P-2) records. Findings included: P-2: The patient was admitted on 1/20/2023 for diagnoses of Diabetes type 2 and surgical wound due to amputation. Upon review of the record, it was noted there were 7 missed visits documented as “RN not available”. During an interview with the administrator (ADM#1) on 2/8/2024 at 2:00 p.m., ADM#1 was asked the reason for 7 out of 12 scheduled visits as “missed due to RN not available”. The response was, “those are contracted nurses, and they don’t have access to document in our electronic medical records.” ADM#1 was asked if paper documents are submitted, the response was, “no, I guess I better get them access to Kinnser.” The agency failed to include documentation of 7 skilled nurse visits, with no documentation that the visits had actually occurred.”

“Contact info for primary care practitioner CFR(s): 484.110(a)(5) Contact information for 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; and This Element is not met as evidenced by: Based on record review and interview, the agency failed to include the name and contact information of the physician on the Plan of Care (POC) or in the clinical record in 1 of 7 records (P-1) reviewed, resulting in the patient/staff of the agency not having the name and contact information of the attending physician. Findings included: P-1: This patient was admitted on 3/3/23. The Plan of Care (POC) for the certification period 12/28/2023 to 2/25/2024 identified a primary diagnosis of Cerebral Infarction due to unspecified occlusion of cerebral artery, and secondary diagnoses of unspecified fall, essential hypertension, and overactive bladder. Upon review of the Plan of Care and the clinical record, there was no contact information that identified 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 Home Health Agency. These findings were reviewed and acknowledged with the Administrator (ADM-1) and Director of Nursing (DON-2) during an interview at 1:00 p.m. on 2/8/24.”

“Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient’s discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient’s care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This Element is not met as evidenced by: Based on record review and interview, the agency failed to include discharge summaries in the patient record and failed to document submission to the physician in 2 of 7 records (P-2, P-5) who were discharged, from a total of 7 records reviewed, resulting in the potential for unidentified continuing health care concerns and unmet care needs. Findings include: P-5: The SOC was dated 7/8/23. The POC identified diagnoses of diabetes mellitus, chronic obstructive pulmonary disease, and bipolar. During record review on 2/5/24, an incomplete discharge OASIS was found in the record, but no discharge summary was documented in the record, and there was no documentation in the record that a discharge summary was sent to the physician. The findings were reviewed with and acknowledged by the administrator (ADM-1) during an interview on 2/8/24 at 1:30 p.m. P-2: The Patient was admitted on 1/20/2023. The POC for the certification period 1/20/23 to 3/20/23 identified diagnoses of Diabetes type 2 (DM2) and Necrotizing Enterocolitis (NEC). The patient was discharged on 3/17/2023 and the D/C OASIS was incomplete. For example, the patient’s blood sugar result on the discharge date was 172-fasting with no documentation that this was reported; and multiple items were not completed on the D/C OASIS. Also, there was no evidence found in the record that a Discharge Summary had been completed or that a discharge summary had been sent to the physician. These findings were reviewed and acknowledged with the Administrator (ADM-1) and Director of Nursing (DON-2) during an interview at 1:00 p.m. on 2/8/24.”