Every finding on record at Giva Tillman

An unannounced on-site complaint investigation 106148 and 106235 was conducted by the Michigan Department of Licensing and Regulatory Affairs from 6/5/24 through 6/6/24 at: All Needs Senior Services 1723 Pucker St. Niles, MI 49120 For this survey: 7 records were reviewed with 1 home visit. The following Condition level deficiencies were identified at: 42 CFR § 484.105: Organization and administration of services. As a result of the Condition level noncompliance, the agency is prohibited for 2 years from offering a Home Health Aide training and competency evaluation or a competency evaluation program as specified in 42 CFR §484.80(f)(3).

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.

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.

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.

A Medicare authorized Emergency Preparedness survey was conducted by the Michigan Department of Licensing and Regulatory Affairs, Bureau of Health Care Services from 2/5/2024 to 2/8/2024 at: All Needs Senior Services 1723 Pucker Street Drive Niles, MI 49120-9998 Clinical records reviewed for this survey included 3 records with home visits and 4 records without home visits for a total of 7 records reviewed. The agency has no branch sites. At the conclusion of the survey the agency was found to be out of compliance with standard level citations at 42 CFR 484.102, Emergency Preparedness.

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).

A Medicare authorized recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs, Bureau of Health Care Services on 2/5/2024 through 2/8/2024 at: All Needs Senior Services 1723 Pucker Street Drive Niles, MI 49120-9998 Clinical records reviewed for this survey included 3 records with home visits and 4 records without home visits for a total of 7 records reviewed. The agency has no branch sites. The following condition level deficiencies were identified during the survey: 42 CFR §484.55 Comprehensive assessment of patients. 42 CFR §484.60 Care planning, coordination of services, and quality of care. 42 CFR §484.65 Quality assessment and performance improvement (QAPI). As a result of the Condition level noncompliance on 2/8/2024 the Agency is prohibited for 2 years from offering a Home Health Aide training and competency evaluation or a competency evaluation program as specified in 42 CFR §484.80(f)(3).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

An unannounced on-site complaint investigation 94255 and 94475 was conducted by the Michigan Department of Licensing and Regulatory Affairs on 35/11/23 at: All Needs Senior Services 1723 Pucker St. Niles, MI 49120 For this survey: 3 records were reviewed without home visits. 1 of 2 allegations were substantiated. At the conclusion of the survey the agency was found to be out of compliance with standard level deficiencies for the conditions of participation for home health agencies at: 42 CFR Part 484.

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 record review and interview, the agency failed to ensure visit frequencies were provided only as ordered by the physician for 1 of 3 (MR# 1) records reviewed, out of a total of 3 records, resulting in the potential for the provision of inappropriate care and services. Findings include: MR#1: The Start of Care (SOC) was dated 10/11/21. The Plan of Care (POC) identified diagnoses of Congenital stenosis of aortic valve and Hypertensive heart disease with heart failure. The complaint intake stated, “MR#1 is supposed to have a nurse come every Monday to fill her meds and that isn't being done regularly.” Additionally, a telephone interview was conducted with the complainant (MR#1) on 5/11/23 at 10:20 am. MR#1 stated, “I don’t recall when, but it was around October of last year when the nurse just stopped coming out for a few weeks in a row to fill my pill box.” During record review on 5/11/23, it was noted that the patient was recertified on 8/6/22 with a Skilled Nurse (SN) frequency of 1w9 (1 time a week for 9 weeks). The POC stated, “Patient relies on nursing to fill pill box for the week. Is unable to consistently remember to take medications on time. Patient has alarm in phone to alert when meds are due.” The SN documented missed visits on 9/6/22, 9/12/22, 9/21/22 and 9/27/22. No physician order or notification was documented. The skilled nurse failed to provide the services and frequency as ordered by the physician.

On 1/26/21 through 1/29/21, an Emergency Preparedness survey was conducted by the Michigan Department of Licensing and Regulatory Affairs. At the survey, All Needs Senior Services was found to be not in substantial compliance with the requirements for participation in Medicare at 42 CFR 484.102 Emergency Preparedness.

Establishment of the Emergency Program (EP) CFR(s): 484.102 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must 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: *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This CONDITION is not met as evidenced by: Based on record review and interview, the Agency failed to develop and update its Emergency Preparedness plan to include plans to address the global pandemic COVID-19 (E0004); failed to develop Emergency Preparedness policies and procedures that addressed the use of volunteers or other emergency staffing strategies during an emergency (E0024); failed to develop and maintain a communication plan for the emergency preparedness plan, including names and contact information for staff, community, state and federal entities providing services, patients' physicians and volunteers, (E0030); failed to develop and maintain an emergency preparedness training and testing program on the COVID-19 disease (E0036); failed to ensure initial training in emergency preparedness policies and procedures was provided to all employees (E0037). The cumulative effect of these systemic problems could potentially have a negative effect on all patients cared for by the home health agency in the event staff is not properly prepared for an emergency for the Condition of Participation of 42 CFR §485.102, Emergency Preparedness.

Develop EP Plan, Review and Update Annually CFR(s): 484.102(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 record review and interview, it was determined the agency failed to develop and update its Emergency Preparedness plan to include plans to address the global pandemic (COVID-19), resulting in staff being ill-prepared to address the crisis and the potential for poor patient outcomes for patients serviced from 3/15/2020 to 1/26/21. Findings include: During the onsite Entrance Conference on 1/26/21 a request was submitted to review the following documents: Employee Roster, Active Patient List, Documented Employee education on the COVID-19 virus and the agency's Emergency Preparedness Plan (EP) and any documented EP revisions and staff's education/training from 3/15/2020 to 1/26/21. During review on 1/28/21 the emergency preparedness program failed to document that it was updated at least every 2 years. These findings were reviewed with and confirmed by the Admin-A (administrator) during an interview on 1/28/21 at 1530 hours.

Policies/Procedures-Volunteers and Staffing CFR(s): 484.102(b)(5) [(b) Policies and procedures. The [facilities] 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 (annually for LTC).] At a minimum, the policies and procedures must address the following:] (6) [or (4), (5), or (7) as noted above] The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. *[For RNHCIs at §403.748(b):] Policies and procedures. (6) The use of volunteers in an emergency and other emergency staffing strategies to address surge needs during an emergency. *[For Hospice at §418.113(b):] Policies and procedures. (4) The use of hospice employees in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop Emergency Preparedness policies and procedures that addressed the use of volunteers or other emergency staffing strategies during an emergency, resulting in the potential for the interruption in care and services for the 21 patients currently serviced by the agency. Findings include: The agency's Emergency Preparedness Plan was reviewed on 1/28/21. During the review, it was noted that there was no documented evidence of policies or procedures that detailed a process for the integration or use of volunteers or other emergency staffing strategies during an emergency. These findings were reviewed with and acknowledged by the Admin-A during an interview on 1/28/21 at 1530 hours.

Names and Contact Information CFR(s): 484.102(c)(1) [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years (annually for LTC).] The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: Based on record review, it was determined the agency failed to develop and maintain a communication plan for the emergency preparedness plan, including names and contact information for staff, community, state and federal entities providing services, patients' physicians and volunteers, affecting all patients served and staff, resulting in the facility not being able to communicate effectively with facility staff, volunteers, other health care providers and emergency preparedness officials should a disaster occur. Findings include: During the 1/28/21 review of the agency's emergency preparedness documents it was noted that there was no evidence the agency developed a communication plan for emergency preparedness that addressed each element of this section and directed how the agency was to communicate with agency staff/volunteers, with other healthcare providers and emergency preparedness officials.

EP Training and Testing CFR(s): 484.102(d) *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, CAHs at §486.625, "Organizations" under 485.727, CMHCs at §485.920, OPOs at §486.360, RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This STANDARD is not met as evidenced by: Based on record review, it was determined the agency failed to develop and maintain an emergency preparedness training and testing program on the COVID-19 disease, for 14 of 14 active staff members, resulting in the potential for staff being unprepared to respond effectively during an actual emergency, which had the potential to affect all patients served by the agency and all staff. Findings include: During a review on 1/28/21 of the agency's emergency preparedness training binder it was noted that 14 of 14 of the home health agency's staff members, that were listed on the active employee list that was submitted by Admin-A (administrator) failed to submit documentation of completing in-services on COVID-19. There was no documented testing of the staff's knowledge on the COVID-19 disease and infection control as it pertains to the emergency preparedness plan.

EP Training Program CFR(s): 484.102(d)(1) *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on record review, it was determined that the agency failed to ensure initial training in emergency preparedness policies and procedures was provided to all employees; failed to provide training of the updated emergency preparedness policies and procedures on the COVID-19 disease; and failed to demonstrate staff knowledge of the emergency preparedness procedures. Findings include: During a review of the agency's emergency preparedness training binder on 1/28/21 it was noted that there was no documented Emergency preparedness training for all fourteen employees for the year 2020. There was no documentation that demonstrated knowledge of the emergency preparedness policies and procedures for the fourteen staff members for the year 2020. And, there was no documented evidence the agency provided training on the updated emergency preparedness policies and procedures on the COVID-19 disease.

On 1/26/21 to 1/29/21, the Michigan Department of Licensing and Regulatory Affairs conducted a Medicare authorized recertification survey along with a focused infection control survey at: All Needs Senior Services 1723 Pucker St. Niles, MI 49120 Clinical records reviewed for this survey: 3 records with home visits and 4 records without home visits for a total of 7 records reviewed. The agency has no branch sites. The following condition level deficiency was identified during the survey: 42 CFR §484.55 Comprehensive assessment of patients. 42 CFR §484.60 Care planning, coordination of services, and quality of care. 42 CFR §484.65 Quality assessment and performance improvement (QAPI). 42 CFR §484.75 Skilled professional services. 42 CFR §484.80 Home health aide services. 42 CFR §484.102 Emergency preparedness. 42 CFR §484.110 Clinical records. As a result of the Condition level noncompliance on 1/29/21, the Agency is prohibited for 2 years from offering a Home Health Aide training and competency evaluation or a competency evaluation program as specified in 42 CFR §484.80(f)(3).

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 observation, record review and interview, the agency failed to ensure patients were informed in advance of the disciplines that will furnish care and the proposed visit frequency in 4 of 7 (MR's # 4, 5, 6, 7) records reviewed, resulting in these patients not having knowledge regarding their plans for treatment. Findings include: **Agency policy "Patient's Rights & Responsibilities" (dated 8/28/14) stated, "Be informed of your rights and responsibilities in advance concerning care/service and by whom (disciplines) service will be provided." MR#4: This patient was admitted to the agency on 12/5/20 with diagnoses of quadriplegic with cerebral palsy, blood stream infection, Osteomyelitis, and pressure ulcers off sacral area and right hip. The comprehensive assessment was completed by DON-A (director of nursing) on 12/5/20. The "Authorization Service Agreement & Consent" was not evident in the 1/27/21 record review. The agency failed to document a patient's consent for treatment, services to be provided and frequency of those services. Additionally, during a joint Medicare home visit with LPN-C (licensed practical nurse) on 1/27/21 at 0900 hours, a review of the patient's agency book failed to disclose a copy of the consent. MR#5: This patient was admitted to the agency on 10/31/20 and recertified on 12/30/20 with diagnoses of hypertension, dementia, and anxiety. The comprehensive assessment was completed by DON-A (director of nursing) on 10/31/20. The "Authorization Service Agreement & Consent" was not evident in the 1/27/21 record review. The agency failed to document a patient's consent for treatment, services to be provided and frequency of those services. MR#6: This patient was admitted to the agency on 12/15/20 with diagnoses of fracture of left femur, chronic kidney disease, and elevated white blood count. The comprehensive assessment was completed by DON-A (director of nursing) on 12/15/20. The "Authorization Service Agreement & Consent" was not evident in the 1/27/21 record review. The agency failed to document a patient's consent for treatment, services to be provided and frequency of those services. MR#7: This patient was admitted to the agency on 8/12/20 and recertified on 10/11/20 with diagnoses of right knee replacement, hypertension, and type 2 diabetes mellitus with hyperglycemia. The comprehensive assessment was completed by RN-B (registered nurse) on 8/12/20. The "Authorization Service Agreement & Consent" was not evident in the 1/27/21 record review. The agency failed to document a patient's consent for treatment, services to be provided and frequency of those services. The findings were reviewed with and acknowledged by Admin-A during an interview on 1/28/21 at 1530 hours. Admin-A stated due to Covid-19 no one has been in the agency scanning documents into the electronic record...I guess we let things go to long..."

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the Agency failed to conduct a patient-specific, comprehensive assessment that accurately reflected the patient's current health status based on past medical history that included dates of onset, exacerbations, treatments and outcomes, measurable data to use as a baseline for future assessments, and history of events leading to current home care needs for 3 of 7 sampled records reviewed (MR#s 1, 2, 3), (Refer to (G-526); failed to ensure the comprehensive assessment included a review of all medications to identify any potential adverse effects, drug reactions, or interactions for 4 of 7 (MR# 2, 4, 6, and 7) records reviewed refer to (G-536); failed to ensure the comprehensive assessments were updated to include an assessment of the patient's current health status and continuing needs for home health services for 1 (MR #2) of 1 record in which the patient was recertified for home care (refer to G-546). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care.

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 observation, record review, and interview, the Agency failed to conduct a patient-specific, comprehensive assessment that accurately reflected the patient's current health status based on past medical history that included dates of onset, exacerbations, treatments and outcomes, measurable data to use as a baseline for future assessments, and history of events leading to current home care needs for 3 of 7 sampled records reviewed (MR#s 1, 2, 3), resulting in incomplete clinical information to aid in determining the current and future care needs of the patient. Findings included: MR#1: The Start of Care (SOC) was dated 10/30/2020. The Plan of Care (POC) for the certification period 10/30/2020 to 12/28/2020 identified diagnoses of Hypertension (HTN), Dysphagia, Dementia, Non-ruptured Cerebral Aneurysm, and Depression. The patient was receiving Skilled Nursing (SN) Home Health aide (HHa), Physical Therapy (PT), and Occupational Therapy (OT) services. Upon review of the comprehensive assessment on 1/26/2021, it was noted the Skilled Nurse (DON-A) failed to document the patient's past medical history that included dates of onset, exacerbations, treatments, current status and outcomes that affected the need for the current admission. The agency used check-marks to indicate the history of diseases experienced by the patient. For example, the patient had a history of Hypertension, dysphagia, dementia, non-ruptured cerebral aneurysm but no further information was provided such as dates of onset, treatments, exacerbations, hospitalizations, or current status of these health conditions that warranted admission to the agency. MR#2: The SOC was dated 6/4/20. The POC for the certification period 12/1/20 to 1/29/21 identified diagnoses of Parkinson's Disease, muscle weakness, Diabetes type 2 (DM2) and Hypertension (HTN). The patient was receiving Skilled Nursing (SN) and Home Health aide (HHa). Upon review of the SOC Comprehensive Assessment on 1/27/2021, it was noted the SN used check marks to indicate the patient had the current disease processes of arrhythmia, rheumatoid arthritis, gait problems, Cerebral Vascular Accident, Transient ischemic attacks, gall stones, and diabetes, however there was no information found in the record of dates of onset, current status of the diseases, including exacerbations or current treatments/conditions that warranted admission to the agency. MR#3: The SOC was dated 2/7/20. The POC for the certification period 10/4/20 to 12/2/20 identified diagnoses of DM2, HTN, dementia, abnormal gait, and fibromyalgia. The patient was receiving SN, HHa, PT, and OT services. Upon review of the comprehensive assessment on 1/26/2021, it was noted the Skilled Nurse (DON-A) failed to document the patient's past medical history that included dates of onset, exacerbations, treatments, current status and outcomes that affected the need for the current admission. The agency used check-marks to indicate the history of diseases experienced by the patient. For example, the patient had a history of DM2, HTN, dementia, fibromyalgia, and an abnormal gait, but no further information was provided such as dates of onset, treatments, exacerbations, hospitalizations, or current status of these health conditions that warranted admission to the agency. These findings were reviewed and Acknowledged during an interview with the Administrator (Admin-A) on 1/29/2021 at 11:30 a.m.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment included a review of all medications to identify any potential adverse effects, drug reactions, or interactions for 4 of 7 (MR# 2, 4, 6, and 7) records reviewed, resulting in the potential for harmful medication effects for these patients. Findings include: MR#4: This patient was admitted to the agency on 12/5/20 with diagnoses of quadriplegic with cerebral palsy, blood stream infection, Osteomyelitis, and pressure ulcers off sacral area and right hip. The comprehensive assessment was completed by DON-A (director of nursing) on 12/5/20. The 1/27/21 review of the comprehensive assessment indicates for (M2001) drug regimen review that no issues were found during the review and that the physician contact (M2003) was not checked no or yes. There was no evidence that a medication review had been completed by DON-A for this patient. A drug review completed on Drugs. Com specified 5 major drug interactions of the 18 drugs listed on the plan of care. Under the area for care coordination, DON-A documents that the physician was contacted regarding the plan of care and start of care. There was no evidence that DON-A completed a "Medication Profile" that lists all the patient's medications, dosage, frequency, and the reason for the drug therapy. The findings were reviewed with Admin-A (administrator) during an interview on 1/28/21 at 1530 hours. 17 medications were listed on the plan of care and 13 medications on the "Medication Profile." The plan of care under orders and treatments included 3 intravenous (IV) drugs, Vancomycin (antibiotic), Ertapenem (antibiotic), and Micafungin (antifungal), but these were not included in the list of medications in the plan of care or "Medication Profile." Admin-A reviewed the electronic medical record and acknowledged there was no evidence that the comprehensive assessment included a review of the patient's medications to identify any potential adverse effects, interactions, and drug reactions. MR#6: This patient was admitted to the agency on 12/15/20 with diagnoses of fracture of left femur, chronic kidney disease, and elevated white blood count. The comprehensive assessment was completed by DON-A (director of nursing) on 12/15/20. There was no evidence that a medication review had been completed by DON-A for this patient. The findings were reviewed with Admin-A (administrator) during an interview on 1/28/21 at 1530 hours. There was no evidence that the comprehensive assessment included a review of the patient's medications to identify any potential adverse effects, interactions, and drug reactions. MR#7: This patient was admitted to the agency on 8/12/20 and recertified on 10/11/20 with diagnoses of right knee replacement, hypertension, and type 2 diabetes mellitus with hyperglycemia. The comprehensive assessment was completed by RN-B (registered nurse) on 8/12/20. The 1/27/21 review of the comprehensive assessment indicates for (M2001) drug regimen review that no issues were found during the review. There was no evidence that a medication review had been completed by RN-B for this patient. The findings were reviewed with Admin-A (administrator) during an interview on 1/28/21 at 1530 hours. There was no evidence that the comprehensive assessment included a review of the patient's medications to identify any potential adverse effects, interactions, and drug reactions. The agency failed to follow its own policy titled, "Comprehensive Patient Assessment" (2015) which states, "To ensure the assessment plan of care is followed that accurately reflects the patient's current health and medical needs...A patient specific, comprehensive assessment will be completed on all patient's receiving care...Review of Medications..." The agency failed to locate a policy regarding "Patient Medication Record." The findings were reviewed with and acknowledged by Admin-A during an interview on 1/28/21 at 1530 hours. MR#2: The SOC was dated 6/4/20. The POC for the certification period 12/1/20 to 1/29/21 identified diagnoses of Parkinson's Disease, muscle weakness, Diabetes type 2 (DM2) and Hypertension (HTN). The patient was receiving Skilled Nursing (SN) and Home Health aide (HHa). Upon review of the Comprehensive Assessment dated 6/4/20, it was noted under the category of "(2001) Drug Regimen Review," the registered nurse, (RN-B), documented, "No, issues found during the review." However, a review of the patient's current medications via drugs.com revealed two major interactions between the following drugs: 1) Carbamazipine and Amlodipine, which when used together result in significant reduction of blood levels of amlodipine. 2) Lithium and Valsartan, when used together causes significant increases of blood levels of Lithium causing lithium intoxication which can be lethal. These findings were reviewed and Acknowledged during an interview with the Administrator (Admin-A) on 1/29/2021 at 11:30 a.m.

Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessments were updated to include an assessment of the patient's current health status and continuing needs for home health services for 1 (MR #2) of 1 record in which the patient was recertified for home care, from a total sample of 7 records reviewed, resulting in the potential for the rendering of ineffective treatment, services, and unmet care needs. Findings included: MR#2: The SOC was dated 6/4/20. The POC for the recertification period 10/2/20 to 11/30/20 identified diagnoses of Parkinson's Disease, muscle weakness, Diabetes type 2 (DM2) and Hypertension (HTN). The patient was receiving Skilled Nursing (SN) and Home Health aide (HHa). The patient was recertified for two additional episodes of care for the recertification periods of 12/1/20 to 1/29/21 and 1/30/21 to 3/31/21. The diagnoses and services were unchanged for the two additional certification periods. During a review of the Recertification OASIS for these 3 certification periods, it was noted that the recertifications did not occur within the required last 5 days of the prior 60-day certification period beginning with the start-of-care date, and there was no documentation indicating there was a beneficiary elected transfer, significant change in condition, or discharge and return to the same agency during the 60-day episodes. This patient had been continuously recertified by the agency since the original Start of Care Date of 6/04/20 and the documented recertification dates on the Recertification OASIS' for each period were as follows: Recertification period 10/2/20 to 11/30/21 was completed on 10/1/20. Recertification period 12/1/20 to 01/29/21 was completed on 11/30/20. For the Recertification period 1/30/21 to 03/31/21 the Recertification OASIS was dated 1/29/21, however the document was blank with except for the patient's demographic information and documented wound measurements with a measurement date of 1/13/21 rather than the date of the visit (1/29/21. The document also had the electronic signature of RN-B with no date. Thus, at the time of the clinical record review, this Recertification Oasis (assessment) document was blank and had not been completed by the Registered Nurse (RN-B), and RN-B copied the wound measurements and dates from a previous home care visit (1/13/21) rather than obtaining the actual measurement while in the patient's home. These findings were reviewed and acknowledged by the Administrator (Admin-A) on 1/29/2021 at 11:30 a.m. with no further comments.

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 provide skilled nursing services as ordered in the plan of care for 1 of 7 (MR# 4) and to document signed physician plans of care in 7 of 7 (MR#s 1, 2, 3, 4, 5, 6, 7) records reviewed (refer to G-572); failed to ensure the plan of care included patient specific safety measures based on the patient's initial assessments in 4 records reviewed (MR#s 1, 2, 6, 7) from a total of 7 records reviewed; and physician orders for PICC line dressing changes for 1 of 1 (MR#4) records reviewed, resulting in patients not receiving care specific to their individual needs and the potential for poor patient outcomes (Refer to G-574); failed to ensure the skilled nurse documented the patient's treatments and medication as ordered by the physician for 2 of 2 (MR# 4, 7) records reviewed in which the treatment was not provided as ordered and failed to provide physical therapy (PT) services in 2 of 5 (MR# 6, 7) medical records in which PT services were ordered (refer to G-578); failed to ensure the physician was notified of changes in the patient's condition in 1 of 1 record reviewed (MR#6) in which the patient had symptoms of a urinary tract infection and not feeling well (Refer to G-590). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care.

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 provide skilled nursing services as ordered in the plan of care for 1 of 7 (MR# 4) and to document signed physician plans of care in 7 of 7 (MR#s 1, 2, 3, 4, 5, 6, 7) records reviewed. This practice results in the potential for unmet needs for one patient and the potential for decline in physical functioning for one patient and patients not being informed of services to be provided and frequency. Findings include: MR#4: This patient was admitted to the agency on 12/5/20 with diagnoses of quadriplegic with cerebral palsy, blood stream infection, osteomyelitis, and pressure ulcers off sacral area and right hip. The plan of care dated 12/5/20 specified, "SN (skilled nursing) 2day42, Eff. (effective) 01/11/2021 3w2, PRN: 0." On 1/1/21 the SN documented only 1 visit for antibiotic IV (intravenous) infusion. There was no documentation in the clinical record on how the 12 hour IV antibiotic infusion was completed or a physician order to not provide the infusion. Also, for this patient during record review on 1/27/21 there was no evidence of a signed physician plan of care in the electronic medical record. MR#5: This patient was admitted to the agency on 10/31/20 and recertified on 12/30/20 with diagnoses of hypertension, dementia, and anxiety. The comprehensive assessment was completed by DON-A (director of nursing) on 10/31/20. There was no evidence of a recertification plan of care dated 12/30/20 during record review on 1/27/21 at 1930 hours. MR#6: This patient was admitted to the agency on 12/15/20 with diagnoses of fracture of left femur, chronic kidney disease, and elevated white blood count. The comprehensive assessment was completed by DON-A (director of nursing) on 12/15/20. There was no evidence of a signed physician plan of care in the electronic medical record when reviewed on 1/27/21. MR#7: This patient was admitted to the agency on 8/12/20 and recertified on 10/11/20 with diagnoses of right knee replacement, hypertension, and type 2 diabetes mellitus with hyperglycemia. The comprehensive assessment was completed by RN-B (registered nurse) on 8/12/20. There was no evidence of a signed physician plan of care in the electronic medical record when reviewed on 1/27/21. The above findings were reviewed with Admin-A (administrator) during an interview on 1/28/21 at 1530 hours. Admin-A agreed with the findings. MR#1: The Start of Care (SOC) was dated 10/30/2020. The Plan of Care (POC) for the certification period 10/30/2020 to 12/28/2020 identified diagnoses of Hypertension (HTN), Dysphagia, Dementia, Non-ruptured Cerebral Aneurysm, and Depression. During a review of the record on 1/26/21, there was no evidence that the plan of care in the electronic medical record had been signed by the physician. In addition, for the recertification period of 12/29/20 to 2/26/20, also reviewed on 1/26/21, there was no indication of a recertification plan signed by the physician to approve care for this patient. MR#2: The SOC was dated 6/4/20. The POC for the recertification period 12/1/20 to 1/29/21 identified diagnoses of Parkinson's Disease, muscle weakness, Diabetes type 2 (DM2) and Hypertension (HTN). The patient was receiving Skilled Nursing (SN) and Home Health aide (HHa). During a review of the electronic record on 1/28/21, there was no evidence that the plan of care had been signed by the physician. In addition, for the certification periods of 6/4/20 to 8/2/20, and recertification periods of 8/3/20 to 10/1/20, and 10/2/20 t0 11/30/20, these plans of care were absent of a physician signature of approval. MR#3: The SOC was dated 2/7/20. The POC for the -recertification period 10/4/20 to 12/2/20 identified diagnoses of DM2, HTN, dementia, abnormal gait, and fibromyalgia. The patient was receiving SN, HHa, PT, and OT services. During a review of the electronic record on 1/29/21, there was no evidence that the plan of care had been signed by the physician. Additionally, the Plan of care for the certification period of 2/7/20 to 4/6/20, and the recertification Plans of Care for 4/7/20 to 6/4/20, 6/5/20 to 8/4/20, and 8/5/20 to 10/3/20, and 12/31/20 to 2/28/21 all were lacking a physician signature for approval of services. These findings were reviewed and acknowledged by the Administrator (Admin-A) during an interview on 1/29/21 at 11:30 a.m. Admin-A stated, we don't put the signed documents in the electronic record. The Admin-A further stated and demonstrated piles of unfiled documents, that were not kept in a locked cabinet or room, and stated, "I just don't have the time to do all the administrative and clerical duties."

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 document review and interview, the agency failed to ensure the plan of care included patient specific safety measures based on the patient's initial assessments in 4 records reviewed (MR#s 1, 2, 6, 7) from a total of 7 records reviewed; and physician orders for PICC line dressing changes for 1 of 1 (MR#4) records reviewed, resulting in patients not receiving care specific to their individual needs and the potential for poor patient outcomes. Findings included: MR#1: The Start of Care (SOC) was dated 10/30/2020. The Plan of Care (POC) for the certification period 10/30/2020 to 12/28/2020 identified diagnoses of Hypertension (HTN), Dysphagia, Dementia, Non-ruptured Cerebral Aneurysm, and Depression. Upon review of the POC, it was noted the following documentation under the category of safety measures, "Anticoagulant Precautions," however the patient was not currently prescribed any anticoagulant medications. In addition, for the certification period of 12/29/20 to 2/26/20, The patient's list of medications did not include any anticoagulants, yet the Plan of Care included anticoagulant precautions under safety measures. These findings were reviewed and acknowledged by the Administrator (Admin-A) during an interview on 1/29/21 at 11:30 a.m. MR#4: This patient was admitted to the agency on 12/5/20 with diagnoses of quadriplegic with cerebral palsy, blood stream infection, osteomyelitis, and pressure ulcers of sacral area and right hip. The plan of care dated 12/5/20 specified IV (intravenous) antibiotics and anti-fungal treatment to right arm PICC (peripherally inserted central catheter) line. The plan of care failed to document specific orders for the frequency and procedure for the PICC line dressing change and monitoring for symptoms of infection. MR#6: This patient was admitted to the agency on 12/15/20 with diagnoses of fracture of left femur, chronic kidney disease, and elevated white blood count. The comprehensive assessment was completed by DON-A (director of nursing) on 12/15/20. The plan of care dated 12/15/20 specified anticoagulant safety precautions, the patient had no documented medications that would require this precaution for bleeding. MR#7: This patient was admitted to the agency on 8/12/20 and recertified on 10/11/20 with diagnoses of right knee replacement, hypertension, and type 2 diabetes mellitus with hyperglycemia. RN-C (registered nurse) completed the recertification comprehensive assessment on 10/11/20. The plan of care dated 10/11/20 specified anticoagulant safety precautions, the patient had no documented medications that would require this precaution for bleeding. The above findings were reviewed with Admin-A (administrator) during an interview on 1/28/21 at 1530 hours. Admin-A agreed with the findings.

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, the agency failed to ensure the skilled nurse documented the patient's treatments and medication as ordered by the physician for 2 of 2 (MR# 4, 7) records reviewed in which the treatment was not provided as ordered and failed to provide physical therapy (PT) services in 2 of 5 (MR# 6, 7) medical records in which PT services were ordered, resulting in no documentation that the physician order was completed and the potential for poor patient outcomes for these patient's. Findings include: MR#4: This patient was admitted to the agency on 12/5/20 with diagnoses of quadriplegic with cerebral palsy, blood stream infection, Osteomyelitis, and pressure ulcers of sacral area and right hip. The plan of care dated 12/5/20 specified IV (intravenous) antibiotics and anti-fungal treatment to right arm PICC line. A physician order on 1/7/21 stated, "Pull PICC line after last dose of antibiotic 1/11/2021." There was no skilled nurse visit documenting the removal of the patient's PICC line found during record review. MR#6: This patient was admitted to the agency on 12/15/20 with diagnoses of fracture of left femur, chronic kidney disease, and elevated white blood count. The comprehensive assessment was completed by DON-A (director of nursing) on 12/15/20. The plan of care dated 12/15/20 ordered skilled nursing, physical therapy, and occupational therapy. The plan of care specified physical therapy services with a frequency and duration stated, "2w8." The PT evaluation was completed on 12/21/20 and a second visit was completed week 2 on 12/23/21. During record review on 1/27/21 there was no PT visits documented for week 1, 3, 4, 5, 6, or 7. MR#7: This patient was admitted to the agency on 8/12/20 and recertified on 10/11/20 with diagnoses of right knee replacement, hypertension, and type 2 diabetes mellitus with hyperglycemia. The recertification plan of care dated 10/11/21 specified skilled nursing, occupational therapy, and physical therapy (PT) services. PT was ordered, "2w4." The PT provided the physician ordered frequency in weeks 1-4, re-evaluating the patient on 11/4/20 and providing additional visits at "1w4." There was no physician order for the extended PT services for week 5-8. Additionally, LPN-D in the 10/16/20 visit note documented, "Fasting blood sugar 154...Discussed insulin order, asked if he gave 14 units..." The 10/11/20 plan of care listed Humalog (quick acting) KwikPen subcutaneous (SubQ) 100 unit/ML 12 units injected SubQ TID (3 times a day) and Lantus (long acting) Solostar subcutaneous 100 unit/ML 20 units at night." There was no physician order for a sliding scale for Humalog. The above findings were reviewed and acknowledged by Admin-A (administrator) during an interview on 1/28/21 at 1530 hours. Admin-A explained that the nurse should have documented a visit note for pulling the PICC line, it was completed but not documented.

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 the patient's condition in 1 of 1 record reviewed (MR#6) in which the patient had symptoms of a urinary tract infection and not feeling well, resulting in a potential for a poor patient outcome. Findings include: MR#6: This patient was admitted to the agency on 12/15/20 with diagnoses of fracture of left femur, chronic kidney disease, and elevated white blood count. The comprehensive assessment was completed by DON-A (director of nursing) on 12/15/20. The plan of care dated 12/15/20 specified skilled nursing services 1w9. During review on 1/27/21 the skilled nursing visit note dated 1/21/21 documented the patient was not feeling well, burning with urination, not dressed (unusual), lying on couch, and a blood pressure of 106/56 and temperature of 98.8 degrees. The plan of care specified parameters for a diastolic pressure under 60 mmHg the SN was to notify physician. There was no evidence that RN-B (registered nurse) notified the physician of the patient's new symptoms or low diastolic blood pressure. The above findings were reviewed and acknowledged with Admin-A (administrator) during an interview on 1/28/21 at 1530 hours.

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 failed to ensure their Quality Assessment and Performance Improvement (QAPI) program was at least capable of showing measurable improvements in indicators to improve patient outcomes, safety and quality of care (refer to G-642); failed to collect and monitor quality indicator data for the Quality Assessment and Performance Improvement program; and failed to ensure the governing body approved the program's frequency and detail of data collection (G-644); failed to initiate any performance improvement activities within their Quality Assessment Performance Improvement (QAPI) program (refer to G-646); the agency failed to develop a Quality Assessment Performance Improvement program that focused on high risk, high volume or problem-prone areas specific to the agency, affecting all 41 patients serviced in the past 12 months (G-648). The cumulative effect of these systemic problems resulted in the agency's inability to improve patient care, health outcomes, patient safety, quality of care, and the agency's performance.

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 failed to ensure their Quality Assessment and Performance Improvement (QAPI) program was at least capable of showing measurable improvements in indicators to improve patient outcomes, safety, and quality of care, resulting in the potential for poor patient outcomes for the agency's current census of 21 patients and the 41 patients admitted in the past year. Findings included: **The agency did not have a Quality Assessment/Performance Improvement Policy. During an interview on 1/27/21 at 3:30 p.m., the Administrator (Admin#1) was asked to provide documentation of the agency's Quality Assessment and Performance Improvement (QAPI). Admin#1 said I will need to find it. When asked what indicators the agency was measuring, the response was, "we do patient satisfaction surveys." When asked to provide the data for the patient satisfaction surveys, she provided a notebook with patient satisfaction forms, but there was no measurable data provided to demonstrate what satisfaction issues the agency should address. The agency failed to ensure the QAPI programs could show measurable improvements in servicing patients based on data collected from Satisfaction surveys. This finding was reviewed and acknowledged by Adm#1 on 1/27/20 at 4:00 p.m.

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to collect and monitor quality indicator data for the Quality Assessment and Performance Improvement program; and failed to ensure the governing body approved the program's frequency and detail of data collection, resulting in the potential for poor patient outcomes for the agency's 41 patients admitted in the past years 2019 and 2020. Findings included: On 3/24/2021, the Administrator (Admin #1) was asked to provide the agency's Quality Assessment and Performance Improvement (QAPI) documentation and evidence of data collection for review. Admin#1 stated, "we use patient satisfactions surveys." When asked what indicators are collected as a result of patient satisfaction surveys, the response was, "we ask if the staff arrive on time, if they are satisfied with the services, and if they have any complaints. "When asked if the governing body had approved the frequency and detail of data collection and had approved the Performance Improvement Project for the following year, Admin-A provided a folder with Advisory Committee Meeting minutes dated April 2019 and April 15, 2020. Admin-A stated, "the Advisory Board is our Governing Board." Upon review of the meeting minutes for April 2019 under the first Category titled "WELCOME," the paragraph was written as follows: "Administrator and Owner of All Needs Senior Services, welcomed the Board Members to the first Annual Professional Advisory Board meeting held on October 28, 2014 at 6:00 p.m"...and the meeting minutes then named all the board members. Under Category #4 "Satisfaction Surveys/Incident Reports," the following was documented, "Data was collected and analyzed from these reports. Outcome showed 80% of incidents in the home were reported falls. A process improvement plan was implemented using the problem solving tool, FOCUS (report attached)." There was no evidence of an attached "FOCUS" report to review. The "All Needs Senior Services, Inc. Advisory Meeting Minutes," dated April 15, 2020 were reviewed. It was noted with the exception of the "Welcome," category of the April 2019 meeting minutes, the meeting minutes for the April 15, 2020 were exactly the same except the first Category was named a "Call to Order." Both documents word for word were exactly the same except for the meeting date at the top of the Documents. Category #4, "Satisfaction Surveys/Incident Reports read exactly the same for both meeting dates (April 2019 and April 2020 minutes) which read, "Data was collected and analyzed from these reports. Outcome showed 80% of incidents in the home were reported falls. A process improvement plan was implemented using the problem solving tool, "FOCUS" (report attached)." In addition there was no proof of data collection for "falls" offered by the Administrator for the years 2019 or 2020. The agency failed to collect and monitor quality indicator data to be presented and approved by the governing body as part of the agency QAPI Program. These findings were reviewed and acknowledged by Admin-A on 3/24/2021 at 1:00 p.m. Admin-A stated, "our Advisory Meeting for 2021 will not occur until April 15 2021."

Program activities CFR(s): 484.65(c) Standard: Program activities. The HHA's performance improvement activities must-- This STANDARD is not met as evidenced by: Based on interview and document review it was determined the Agency (HHA) failed to initiate any performance improvement activities within their Quality Assessment Performance Improvement (QAPI) program, resulting in the potential for the rendering of substandard care and unmet care needs for the current 21 patients receiving services from the agency. Findings included: **The agency did not have a Quality Assessment/Performance Improvement Policy. On 1/27/21 the Administrator (Admin#1) was asked what activities the agency had initiated for the Quality Assessment and Performance Improvement Program (QAPI). Admin#1 asked what do you mean? Admin was asked what performance improvement project have you initiated as a result of the data collected from the Patient Satisfaction Surveys? The response was, "we currently do not have a project. We are still collecting data from our Patient Satisfaction Surveys to determine what needs to be improved." The agency had no documentation of activities for the QAPI program.

High risk, high volume, or problem-prone area CFR(s): 484.65(c)(1)(i) (i) Focus on high risk, high volume, or problem-prone areas; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to develop a Quality Assessment Performance Improvement program that focused on high risk, high volume or problem-prone areas specific to the agency, affecting all 41 patients serviced in the past 12 months, resulting in the agency's inability to improve patient care, health outcomes, patient safety, quality of care and the agency's performance. Findings included: During an interview with the Administrator (Admin#1) on 1/27/21, Admin#1 was asked what type of patient risk or diagnoses tend to be problem-prone within the agency. The response was, "we get all types of diagnoses, and use our patient satisfaction surveys to determine where the problems are." When asked to state what the problem prone areas are and what projects have been put in place to improve them, there was no response." The HHA failed to develop a QAPI program that focused on high risk, high volume or problem-prone areas of the agency, to monitor the agency's improvement in these areas.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on record review, observation and interview, it was determined the Registered Nurse failed to supervise the services provided by the Licensed Practical Nurse (LPN) in providing wound care to 1 of 1 record reviewed with wound services (MR# 4) and LPN supervision with a home visit in 1 of 1 record reviewed (MR# 7) (G726). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care.

Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This ELEMENT is not met as evidenced by: Based on record review, observation and interview, it was determined the Registered Nurse failed to supervise the services provided by the Licensed Practical Nurse (LPN) in providing wound care to 1 of 1 records reviewed with wound services (MR# 4) and LPN supervision with a home visit in 1 of 1 records reviewed (MR# 7), resulting in failure of the LPN to provide wound care in an infection free manner with a potential infection breach for a compromised patient and no onsite LPN supervision documented. Findings include: MR#4: This patient was admitted to the agency on 12/5/20 with diagnoses of quadriplegic with cerebral palsy, blood stream infection, osteomyelitis, and stage 4 pressure ulcers of sacral area and right hip. The plan of care updated 1/14/21 specified, "SN (skilled nursing) 2day42, Eff. (effective) 01/11/2021 3w2, PRN: 0. Cleansing the wound: Wash hands with mild soap and water. Apply gloves, gently remove old dressing and cleanse wound with normal saline or wound cleanser. Remove soiled gloves and wash hands with mild soap and water. Apply new gloves and apply new dressing. Wound Dressings: Cleanse the as directed above. Coccyx: Cleansed and applied gentian violet in clinic today, then triad. Apply triad daily to every other day and as needed. Right hip and right ischium: Cleanse and apply endoform and hydrofera blue classic, cover with optifoam. Change MWF and as needed." During a 1/27/21 0900 hours joint Medicare home visit with LPN-C, she was observed providing wound care to the patient's stage 4 pressure ulcer to right hip and sacral region. LPN-C sprayed wound cleaner on clean 4X4 gauze pads, she cleanse the skin surrounding the wound with 1 set of gauze pads and then with the same pad entered the deep wound and completed the wound cleansing on the right posterior hip. A new 4X4 was sprayed again with wound cleanser, she was observed cleansing skin surrounding the wound first and with the same pad cleansed the deep sacral pressure ulcer. This procedure allowed the bacteria on the skin to be introduced deep into the pressure ulcer tunnel. DON-A (director of nursing) documented a home visit on 1/3/21 with supervision of the LPN, the LPN was not present at the visit. There was no evidence found in the clinical record that the registered nurse had observed LPN-C in the wound treatment procedure for this patient and identified an infection control problem. MR#7: This patient was admitted to the agency on 8/12/20 and recertified on 10/11/20 with diagnoses of right knee replacement, hypertension, and type 2 diabetes mellitus with hyperglycemia. RN-C (registered nurse) completed the recertification comprehensive assessment on 10/11/20. The plan of care dated 10/11/20 specified skilled nursing services with a frequency ordered, "lw9." LPN-D provided the visits for the recertification period. The RN documented a LPN supervision on 11/9/20 (week 5), but failed to provide documentation that a home visit was made to the patient's home. During an interview on 1/27/21 at 1000 hours, Admin-A and RN-B (registered nurse) after discussing the wound care observed by LPN-C on MR#4 stated, "The LPN should never wash the external skin of the wound and then use the same 4X4 to cleanse the pressure ulcer tunnel."

Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure the home health aide received a minimum of 12 in-service hours (G774); failed to ensure the RN (registered nurse) prepared written patient care instructions alerting the home health aide (HHa) to the safety precautions and special conditions that were applicable to each patient, for 4 of 5 records reviewed (MR#'s 1, 2, 3, 5) (G798); and failed to ensure on-site supervisory visits to the patient's home was completed by the registered nurse at least every 14-days to supervise the care provided by the home health aide for 1 of 5 (MR#5) records reviewed (G808). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of safe and quality services by competent home health aides for the Condition of Participation of 42 CFR §484.80, Home Health Aide Services.

12 hours inservice every 12 months CFR(s): 484.80(d) Standard: In-service training. A home health aide must receive at least l2 hours of in-service training during each 12-month period. In-service training may occur while an aide is furnishing care to a patient. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the home health aide received a minimum of 12 in-service hours in 2020 for 2 of 2 (Aide#1 and Aide#2) home health aides employed by the agency for more than 12 months, resulting in a lack of educational opportunities pertinent to patient care for the aides. This deficient practice could affect all patients receiving aide services. Findings include: Aide#1: Date of hire 11/20/13. On 1/28/21 the personnel file for Aide#1 and the in-service training was requested. The agency failed to provide any in-service to meet the 12 hours of training for 2020, 2019, and 2018 as requested. Aide#2: Date of hire 8/28/19. On 1/28/21 the personnel file for Aide#2 and the in-service training was requested. The agency failed to provide any in-service to meet the 12 hours of training for 2020 as requested. There was no documented evidence to confirm that Aide#1 and Aide#2 had received 12 hours of in-service training in 2020. During an interview on 1/28/21 at 1330 hours Admin-A stated they could not locate the training for the aides.

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, observation, and interview, the agency failed to ensure the RN (registered nurse) prepared written patient care instructions alerting the home health aide (HHa) to the safety precautions and special conditions that were applicable to each patient, for 4 of 5 records reviewed (MR#'s 1, 2, 3, 5) in which HHa services were ordered, from a total sample of 7 records reviewed, resulting in the potential for injury to the patients receiving aide services. Findings include: MR#1: The Start of Care (SOC) was dated 10/30/2020. The Plan of Care (POC) for the certification period 10/30/2020 to 12/28/2020 identified diagnoses of Hypertension (HTN), Dysphagia, Dementia, Non-ruptured Cerbral Aneurysm, and Depression. The patient was receiving Skilled Nursing (SN), Home Health aide (HHa), Physical Therapy (PT), and Occupational Therapy (OT) Services. The POC included the following safety measures: "Keep pathways clear, instruct on mobility safety, support during transfer and ambulation, instruct on safe utilities management, anticoagulant precautions, safety in ADLs, proper position during meals, fall precautions, and fall precautions. Upon review of the HHa Care Plan, it was noted the HHa Care Plan failed to include any of the safety measures documented on the Plan of Care with the potential to result in injury to this patient. MR#2: The SOC was dated 6/4/20. The POC for the certification period 12/1/20 to 1/29/21 identified diagnoses of Parkinson's Disease, muscle weakness, Diabetes type 2 (DM2) and Hypertension (HTN). The patient was receiving Skilled Nursing (SN) and Home Health aide (HHa). The Plan of Care included the following safety measures: mobility safety, safety in ADLs, fall precautions, use of assitive devices, proper handling of biohazard waste and sharps container. Upon review of the HHa Care Plan, it was noted the HHa Care Plan failed to include any of the safety measures documented on the Plan of Care with the potential to result in injury to this patient. MR#3: The SOC was dated 2/7/20. The POC for the certification period 10/4/20 to 12/2/20 identified diagnoses of DM2, HTN, dementia, abnormal gait, and fibromyalgia. The patient was receiving SN, HHa, PT, and OT services. The POC included the following safety measures, "Keep pathway clear, instruct on DME and electrical safety, instruct on medical oxygen gas, instruct on mobility safety, support during transfer and ambulation, safety in ADLs, sharps safety, fall precautions, use of assistive devices, proper handling of biohazaard waste." Upon review of the HHa Care Plan, it was noted the HHa Care Plan failed to include any of the safety measures documented on the Plan of Care with the potential to result in injury to this patient. These findings were reviewed and acknowledged by the Administrator on 1/29/2021 at 11:30 a.m. MR#5: This patient was admitted to the agency on 10/31/20 and recertified on 12/30/20 with diagnoses of hypertension, dementia, and anxiety. The comprehensive assessment was completed by DON-A (director of nursing) on 10/31/20 and a recertification assessment on 12/26/20. The patient was being provided nursing and aide services. The aide care plan dated 12/30/20 failed to include safety precautions. Additionally, the physician order dated 1/20/21 and signed by DON-A stated, "SN: Eff. 12/30/20 1w9, PRN: 0, HHA: Eff. 12/30/20 3w8, PRN:0." The aide care plan dated 12/30/20 signed by DON-A stated, "Aide Frequency: 2w9." The aide provided 2 visits a week starting 12/30/20 to 12/22/21. DON-A failed to complete the aide care plan with the same frequency on the plan of care. The above findings were reviewed and acknowledged with Admin-A (administrator) during an interview on 1/28/21 at 1530 hours.

Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech-language pathology services, a registered nurse or other appropriate skilled professional who is familiar with the patient, the patient's plan of care, and the written patient care instructions described in §484.80(g), must make an onsite visit to the patient's home no less frequently than every 14 days. The home health aide does not have to be present during this visit. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure on-site supervisory visits to the patient's home were completed by the registered nurse at least every 14-days to supervise the care provided by the home health aide for 1 of 5 (MR#5) records reviewed in which aide services were provided for a period of time greater than 2 weeks, resulting in a lack of oversight of aide care and services for this one patient. Findings include: MR#5: This patient was admitted to the agency on 10/31/20 and recertified on 12/30/20 with diagnoses of hypertension, dementia, and anxiety. The comprehensive assessment was completed by DON-A (director of nursing) on 10/31/20 and a recertification assessment on 12/26/20. The patient was being provided nursing and aide services. The aide care plan dated 12/30/20 specified aide frequency 2w9. During week 3 (1/10/21 to 1/16/21) the RN documented an aide supervision on 1/12/21, there was no RN visit made on that date. The above findings were reviewed and acknowledged with Admin-A (administrator) during an interview on 1/28/21 at 1530 hours.

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on record review, observation, and interview, the agency failed to document referrals in 3 of 7 (MR#s 4, 5, 6) records reviewed, failed to document patient consents for services and frequency in 4 of 7 (MR# 4, 5, 6, 7) records reviewed, failed to document visit notes in 1 of 7 (MR# 6) records reviewed, failed to have physician signed plans of care and orders in 7 of 7 (MR#s 1, 2, 3, 4, 5, 6, 7) records reviewed (G1010); failed to ensure the plan of care included individualized measurable goals and outcomes, and visit notes failed to document the patient's progress towards achieving those identified goals in 3 of 7 records reviewed (MR# 1, 2 and 3) out of a total of 7 sampled records reviewed (G1016); failed to ensure a discharge summary was sent to the physician within 5 business days of the patient's discharge for 2 of 2 (MR#s 3 and 7) records reviewed (G1022); failed to ensure that clinical records were safeguarded against loss or unauthorized use for 7 of 7 records reviewed (MR#s 1, 2, 3, 4, 5, 6, and 7) from a total of 7 sampled records reviewed (G1028). 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§484.110 Clinical Records.

Contents of clinical record CFR(s): 484.110(a) Standard: Contents of clinical record. The record must include: This STANDARD is not met as evidenced by: Based on record review, observation, and interview, the agency failed to document referrals in 3 of 7 (MR#s 4, 5, 6) records reviewed, failed to document patient consents for services and frequency in 4 of 7 (MR# 4, 5, 6, 7) records reviewed, failed to document visit notes in 1 of 7 (MR# 6) records reviewed, failed to have physician signed plans of care and orders in 4 of 7 (MR# 4, 5, 6, 7) failed to complete documentation in the medical records and document the care the patient received in a timely manner (MR #2) records reviewed, resulting in records not being complete for review and patient's not getting services needed. Findings include: MR#4: This patient was admitted to the agency on 12/5/20 with diagnoses of quadriplegic with cerebral palsy, blood stream infection, Osteomyelitis, and pressure ulcers off sacral area and right hip. No referral was documented in the electronic clinic record. The patient consent was not evident in the clinical record or in the home. There was no evidence in the clinical record of a signed plan of care and physician orders. During the survey from 1/26/21 to 1/29/21 observed was piles of paper on the desk, the Admin-A made frequent reference to the piles of paper on the desk and in files that had not been scanned in the clinical record or filed. MR#5: This patient was admitted to the agency on 10/31/20 and recertified on 12/30/20 with diagnoses of hypertension, dementia, and anxiety. No referral was documented in the electronic clinic record. The patient consent was not evident in the clinical record. There was no evidence in the clinical record of a signed plan of care and physician orders. During the survey from 1/26/21 to 1/29/21 observed was piles of paper on the desk, the Admin-A made frequent reference to the piles of paper on the desk and in files that had not been scanned in the clinical record or filed. MR#6: This patient was admitted to the agency on 12/15/20 with diagnoses of fracture of left femur, chronic kidney disease, and elevated white blood count. No referral was documented in the electronic clinic record. The patient consent was not evident in the clinical record. The physical therapy failed to document visit notes from 12/27/20-1/27/21. There was no evidence in the clinical record of a signed plan of care and physician orders. During the survey from 1/26/21 to 1/29/21 observed was piles of paper on the desk, the Admin-A made frequent reference to the piles of paper on the desk and in files that had not been scanned in the clinical record or filed. MR#7: This patient was admitted to the agency on 8/12/20 and recertified on 10/11/20 with diagnoses of right knee replacement, hypertension, and type 2 diabetes mellitus with hyperglycemia. The patient consent was not evident in the clinical record. There was no evidence in the clinical record of a signed plan of care and physician orders. During the survey from 1/26/21 to 1/29/21 observed was piles of paper on the desk, the Admin-A made frequent reference to the piles of paper on the desk and in files that had not been scanned in the clinical record or filed. During an interview on 1/28/21 at 1530 hours, Admin-A (administrator) acknowledged that all these identified areas of deficiency above were affecting their ability to provide services. MR#2: The SOC was dated 6/4/20. The POCs for the certification period 1/30/21 to 3/31/21 was reviewed and identified diagnoses of Parkinson's Disease, muscle weakness, Diabetes type 2 (DM2) and Hypertension (HTN). The patient was receiving Skilled Nursing (SN) and Home Health aide (HHa) services. The recertification Oasis's dated 1/29/21 was reviewed on 1/29/21 at 11:00 a.m. During the review it was noted that the document was blank except for the demographic information and the wound care measurement form which had wound measurements dated 1/13/21 documented rather than documenting the actual measurements taken the day of the visit (1/29/21), and an electronic signature by RN-B with no date. This finding was reviewed and acknowledged by the Administrator (Admin-A) during an interview on 1/29/21 at 11:30 a.m.

Goals in the patient's plans of care CFR(s): 484.110(a)(3) Goals in the patient's plans of care and the patient's progress toward achieving them; This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the Home Health Agency failed to ensure the plan of care included individualized measurable goals and outcomes, and visit notes failed to document the patient's progress towards achieving those identified goals in 3 of 7 records reviewed (MR# 1, 2 and 3) out of a total of 7 sampled records reviewed, resulting in the potential for failure to achieve goals/outcomes identified by the patient, and the measurable outcomes identified by the organization. Findings included: MR#1: The Start of Care (SOC) was dated 10/30/2020. The Plan of Care (POC) for the certification period 10/30/2020 to 12/28/2020 identified diagnoses of Hypertension (HTN), Dysphagia, Dementia, Non-ruptured Cerebral Aneurysm, and Depression. During a review of the Plan of Care, it was noted the goals were not objectively measurable. Findings included: "Patient's skin integrity will remain intact during the episode; Patient's ADL/IADL needs will be met with the assistance of home health aide." The goals are not individualized or objectively measurable. MR#2: The SOC was dated 6/4/20. The POCs for the certification period 1/30/21 to 3/31/21 was reviewed and identified diagnoses of Parkinson's Disease, muscle weakness, Diabetes type 2 (DM2) and Hypertension (HTN). The patient was receiving Skilled Nursing (SN) and Home Health aide (HHa) services. Upon review of the Plan of Care, it was noted that the goals were not objectively measurable. Examples include: "Home exercise program will be established by physical therapist; Patient will not develop any signs and symptoms of dehydration during the episode; Patient's ADL/IADL needs will be met with assistance of home health aide." These goals are not individualized or objectively measurable. MR#3: The SOC was dated 2/7/20. The POC for the certification period 10/4/20 to 12/2/20 identified diagnoses of DM2, HTN, dementia, abnormal gait, and fibromyalgia. The patient was receiving SN, HHa, PT, and OT services. Upon review of the Plan of Care, it was noted that the goals were not objectively measurable. Examples include, "The patient/caregiver will verbalize understanding of individualized emergency plan by 2/28/2020; Patient skin integrity will remain intact during this episode; Patient will not develop any sign or symptoms of dehydration during the episode." These goals are not individualized or objectively measurable. These findings were reviewed and acknowledged by the Administrator during an interview on 1/29/20 at 1:00 p.m.

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 ensure a discharge summary was sent to the physician within 5 business days of the patient's discharge for 2 of 2 (MR#s 3 and 7) records reviewed in which the patient was discharged from the agency, resulting in the physician not having knowledge of the patient's health status at the time of discharge which has the potential to negatively affect the patients discharged from the agency in the past twelve months. Findings include: MR#7: This patient was admitted to the agency on 8/12/20 and recertified on 10/11/20 with diagnoses of right knee replacement, hypertension, and type 2 diabetes mellitus with hyperglycemia. The patient was discharged 12/8/20 with a discharge OASIS (outcome and assessment information set) completed by RN-B (registered nurse). Record review on 1/27/21 indicates there was no documented evidence a discharge summary was sent to the physician within 5 business days of the patient's discharge. The above findings were reviewed with Admin-A (administrator) during an interview on 1/28/21 at 1530 hours. Admin-A agreed with the findings. MR#3: The SOC was dated 2/7/20. The POC for the certification period 10/4/20 to 12/2/20 identified diagnoses of DM2, HTN, dementia, abnormal gait, and fibromyalgia. The patient was receiving SN, HHa, PT, and OT services. The patient was discharged 11/30/20 with a discharge OASIS (outcome and assessment information set) completed by RN-B (registered nurse). Record review on 1/29/21 indicates there was no documented evidence the discharge summary was sent to the physician within 5 business days of the patient's discharge. This finding was reviewed and acknowledged by the Administrator (Admin-A) during an interview on 1/29/21 at 11:30 p.m.

Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure that clinical records were safeguarded against loss or unauthorized use for 7 of 7 records reviewed (MR#s 1, 2, 3, 4, 5, 6, and 7) from a total of 7 sampled records reviewed, resulting in the potential compromise of protected health information and the potential for compromise of protected health information for all patients serviced by the agency. Findings included: On 1/28/21 at 2:30 p.m., during an interview with the Administrator (Admin#1), several documents from patient records which could not be found in the electronic medical records were requested. Admin#1 explained that those documents would be in the hard chart, and she was behind on filing patient documents and pointed to a large pile of documents on a table needing to be filed into the patient records. The documents were not locked in a closet or cabinet to protect from loss or unauthorized use, resulting in the potential for compromise of protected health information for all patients serviced by the agency. Admin#1 stated, "I just don't have the time to do all the administrative and clerical duties." These findings were confirmed by the Administrator (Admin#1) during an interview on 1/28/20 at 1:00 p.m.