Reliable Home Health Patient Care Co

“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 document review and interview, it was determined that the Agency failed to ensure the Plan of Care (POC) included objectively measurable and individualized goals in 1 (Patient/P-1) of 5 records reviewed with Skilled Nursing (SN) ordered out of a total sample of 7 records reviewed; failed to include all pertinent safety precautions in 1 (P-1) of 7 records reviewed; and failed to incorporate safety parameters concerning blood oxygen levels (See G 574); failed to ensure that treatment/interventions were provided only in accordance with physician’s orders for 1 (P-1) of 7 records reviewed (See G 580); failed to ensure the physician was promptly notified of signs and symptoms of fluid overload in 1 (P-1) of 1 record reviewed with SCIC (significant change in condition) out of 7 records reviewed (See G 590), and failed to ensure the revised Plan of Care reflected the current information from the updated comprehensive assessment in 1 (P-1) of 1 record reviewed with a ROC (resumption of care) post-hospitalization out of a total of 7 records reviewed (See G 592). 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 42 CFR §484.60 Care Planning, Coordination, Quality of Care.”

“Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA’s governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA’s performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This Condition is not met as evidenced by: Based on interview and record review, it was determined the Agency failed to provide evidence of its efforts to measure, track and analyze it’s quality indicators and show measurable improvement in patient care and services (See G 642); failed to develop Performance Improvement activities, as part of the Agency’s Quality Assessment Performance Improvement program, in order to track and trend adverse patient events, analyze the cause and implement preventive interventions (See G 654); failed to document any of the required annual quality improvement projects since 2023 through 5/27/25, including the reasoning for conducting these projects and the measurable progress achieved each year (See G 658); and failed to ensure the Agency had an active and functioning Quality Assessment and Performance Improvement program that addressed priorities for improved quality of care and patient safety which evaluated its effectiveness (See G660). The cumulative effect of these systemic problems resulted in the Agency’s inability to ensure the provision of quality health care for all patients the Home Health Agency has serviced for the condition of participation of 42 CFR§484.65 Quality Assessment and Performance Improvement (QAPI).”

“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 1 of 1 home health aides (HHA-1) had the required in-services documented in the record, see (G-774); and failed to ensure a yearly on-site home health aide supervisory visit for HHA-1 was documented in the record, see (G-812). 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, which could result in the agency not providing quality health care.”

“Development of EP Policies and Procedures CFR(s): 484.102(b) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [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. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility 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 annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization 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 address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility 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. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. This Standard is not met as evidenced by: Based on record review and interview, the Agency failed to develop and update Emergency Preparedness (EP) policies and procedures that were based on an agreed upon all-hazards risk assessment, resulting in the Agency’s inability to implement appropriate emergency actions which could negatively affect the health and safety of all patients serviced by the Agency. Findings include: The Agency’s Emergency Preparedness (EP) binder was reviewed on 5/28/25. During review, it was noted that 7 different versions of the all-hazards risk assessments were being utilized. Seven staff members each filled out a separate all-hazards risk assessment and no two were identical. For example, a basic hazard such as water/flooding were identified as a high risk on one risk assessment and a low risk on another. Subsequently, the Agency did not have an agreed upon response for various emergency situations, potentially putting the patient’s and staff safety at risk. The Administrator (Adm-1) reviewed and acknowledged the above findings during an interview on 5/28/24 at 3:10 PM. Adm-1 noted that only one master all-hazards risk assessment would be used going forward.”

“EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, “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 PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE 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 and interview, it was determined that the home health agency (HHA) failed to document initial training in emergency preparedness policies and procedures for 7 of 8 (PT-1, PT-2, PT-3, RN-1, RN-2, HHa-1, DON-1) employee records reviewed, including contract employees, and failed to maintain documentation of training for 7 of 8 (PT-1, PT-2, PT-3, RN-1, RN-2, HHa-1, DON-1) employees, resulting in the potential for inappropriate, unprepared responses to emergencies and interruption in the provision of needed patient care and services. Findings include: During review of employee records on 5/30/25, it was discovered that 7 of 8 (PT-1, PT-2, PT-3, RN-1, RN-2, HHa-1, DON-1) employee files reviewed had no documented evidence of initial or ongoing Emergency Preparedness training. There was no indication that initial Emergency Preparedness training had been provided to all 8 staff records reviewed, including contracted staff, as required, and no staff attendance sheet was available. The agency failed to document initial training in Emergency Preparedness policies and procedures to all new and existing staff, including contract employees, and failed to maintain documentation of training. During an interview on 5/30/25 at 1:35 p.m., the administrator (ADM-1) and the Director of Nursing (DON-1) acknowledged the above findings.”

“Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This Standard is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to develop, implement, and maintain a Quality Assessment and Performance Improvement (QAPI) program which provided documentation of its efforts to measure, track and analyze quality indicators that represented pre-established performance improvement projects (PIP’s) designed to optimize patient care services, and failed to have measures in place to recognize the highest level of a poor outcome (death), resulting in the inability to determine the quality of services provided and the potential unmet care needs for all 11 active patients currently being served by this Agency. Findings include: On 5/29/25, the Agency’s QAPI documentation was reviewed which revealed a failure to document efforts to systematically collect data, monitor, analyze and improve patient outcomes based off the Governing Body approved PIP’s. Review of the QAPI binder since 2022 noted 3 annual QAPI meetings (last being 10/18/24). Each of the QAPI meetings concerning its QAPI program were entirely based off a half page of autogenerated data from iQIES “Outcome Reports” which focused on aide services, management of oral medications and patient falls with injury. The Agency was in line for aide services and falls and below national averages concerning management of oral medications (85.6% in 2024 compared to 96.5% National and 84.5% in 2023 vs. 96.5% National). No evidence was found in the QAPI program of any efforts made by the Agency to develop its QAPI program to identify areas of improvement. The lone area identified regarding oral medications above had no follow-up activities or evidence it was addressed in any manner. An area of concern was also identified during the survey on 5/29/25, patient record (P-1) who died at home after a SCIC (significant change in condition) was documented by skilled nursing services regarding potential fluid overload. The Agency failed to have any measures in place to capture this sentinel event which went unnoticed by the Agency since 6/14/24. No effort was made by the Agency to determine if the SCIC potentially contributed to P-1’s death. The Administrator and Director of Nursing reviewed and acknowledged the findings above during an interview on 5/29/25 at 4:10 PM. The Agency failed to adhere to its policy referenced below. Agency Policy: “Quality Assessment and Performance Improvement (QAPI)” (undated) stated on pg. 1 the following: “The Agency has established an ongoing program of quality assessment and performance improvement. To collect and analyze data to improve identified processes of patient care/services as well as outcomes of patient care... To establish mechanisms to reprioritize QAPI activities in response to unusual and/or urgent events. To allocate adequate resources for QAPI.””

“Track adverse patient events CFR(s): 484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. This Standard is not met as evidenced by: Based on record review and interview, the Agency failed to develop performance improvement activities, as part of the Agency’s Quality Assessment Performance Improvement (QAPI) program, to track and trend adverse patient events, analyze the cause and implement preventive interventions, resulting in the potential for the rendering of substandard care and unmet care needs for all 11 patients currently receiving services. On 5/29/25, during review of the Agency’s QAPI documents since 2022, it was noted there was no evidence that the Agency had attempted to implement any quality improvement measures or activities that would serve to track/trend adverse patient events, analyze causative factors and implement preventive interventions. Further, an area of concern was identified during the survey on 5/29/25, regarding an adverse event for patient record (P-1) who died at home after a SCIC (significant change in condition) was documented by skilled nursing services regarding potential fluid overload. The Agency failed to have any quality performance activities in place to capture this sentinel event which went unnoticed by the Agency since 6/14/24. The Administrator and Director of Nursing reviewed and acknowledged the findings above during an interview on 5/29/25 at 4:20 PM. The Agency failed to adhere to its policy referenced below. Agency Policy: “Quality Assessment and Performance Improvement (QAPI)” (undated) stated on pg. 1 the following: “The Agency has established an ongoing program of quality assessment and performance improvement. To establish mechanisms to reprioritize QAPI activities in response to unusual and/or urgent events. To allocate adequate resources for QAPI.””

“Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA’s services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This Standard is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to develop a Performance Improvement Project (PIP) within its QAPI (Quality Assessment Performance Improvement) program, resulting in the Agency’s inability to effectively monitor proposed improvements in patient care, health outcomes, patient safety, quality of care and overall performance for all patients. Findings include: On 5/29/25, the Agency’s QAPI documentation was reviewed since 2022, and found no evidence of a PIP that was chosen and approved to gather information to track and tread towards pre-established goals for quality improvement for the last 3 years. The Administrator and Director of Nursing reviewed and acknowledged the findings above during an interview on 5/29/25 at 4:25 PM. The Agency failed to adhere to its policy referenced below. Agency Policy: “Quality Assessment and Performance Improvement (QAPI)” (undated) stated on pg. 1 the following: “The Agency has established an ongoing program of quality assessment and performance improvement. To create and maintain information systems (manual and/or computer) to support the collecting, managing and analyzing of data needed to facilitate ongoing QAPI.” The Agency’s QAPI policy failed to contain language that directly acknowledged and detailed the utilization of PIP’s.”

“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, it was determined the Governing Body failed to ensure the Agency had an active and functioning Quality Assessment and Performance Improvement (QAPI) program that addressed priorities for improved quality of care, maintained patient safety standards, and was evaluated for its effectiveness, resulting in the potential to adversely affect the quality of care to all 11 patients currently receiving services and all 67 patients admitted over the past year. Findings include: On 5/29/25, the Agency’s QAPI documentation was reviewed and revealed a failure to document efforts to systematically collect data, monitor, analyze and improve patient outcomes based off the Governing Body (GB) meeting minutes. Review of the QAPI binder since 2022 noted 3 annual QAPI meetings (last being 10/18/24). Each of the QAPI meetings concerning its QAPI program were entirely based off a half page of autogenerated data from iQIES “Outcome Reports” which focused on aide services, management of oral medications and patient falls with injury. The Agency was in line for aide services and falls but below national averages concerning management of oral medications (85.6% in 2024 compared to 96.5% National and 84.5% in 2023 vs. 96.5% National). No evidence was found that the GB made any efforts to develop its QAPI program to identify areas of improvement. One area that could be improved from the Outcome Reports was oral medications noted above, but the GB failed to recognize this opportunity for the last two years. An area of concern was also identified during the survey on 5/29/25, patient record (P-1) who died at home after a SCIC (significant change in condition) was documented by skilled nursing services regarding potential fluid overload. The GB failed to have any measures in place to capture this sentinel event which went unnoticed by the Agency since 6/14/24. No effort was made by the GB to determine if the SCIC potentially contributed to P-1’s death. The Administrator and Director of Nursing reviewed and acknowledged the findings above during an interview on 5/29/25 at 4:15 PM. The Agency failed to adhere to its policy referenced below. Agency Policy: “Quality Assessment and Performance Improvement (QAPI)” (undated) stated on pg. 1 the following: “The Governing Body is ultimately responsible for QAPI and implementation of the QAPI plan.””

“Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA’s quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This Standard is not met as evidenced by: Based on record review and interview, the Agency failed to maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases as a part of the Agency’s QAPI (Quality Assessment Performance Improvement) program, resulting in the potential spread of infections between patient care staff and the Agency’s 67 patients admitted in the past year. Findings include: On 5/29/25, the Agency’s QAPI program concerning infection control was reviewed. Since 2023, documentation of infection control data with coordinated analysis, discussions with resultant actions for improvement were not found during the recertification survey. The Agency did provide documentation of patient infections with their associated outcomes. However, the Agency failed to produce any evidence which utilized collected data for analysis. The patient infection data collected was never tracked and trended towards pre-established goals focusing on improving infection control. The Administrator and Director of Nursing reviewed and acknowledged the findings above during an interview on 5/29/25 at 4:15 PM.”

“Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This Standard is not met as evidenced by: Based on record review, and interview, it was determined the Home Health Agency failed to provide documented evidence that infection control education was provided to 2 of 8 employee records (PT-1, PT-3) reviewed, including contracted staff, employed by the agency and who were granted clinical privileges, resulting in the potential for the development and spread of infection to all patients. Findings include: On 5/30/25, during review of 8 clinical employee records, it was noted that infection control in-service education was not documented for 2 of 8 employees (PT-1, PT-3), and 2 of the 8 employees (RN-1, PT-2) had no infection control education since 2023. The agency failed to provide the required infection control education and in-services to all staff, including contracted staff. During an interview on 5/30/25 at 1:35 p.m., the administrator (ADM-1) and the Director of Nursing (DON-1) acknowledged the above findings.”

“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 1 of 1 home health aides (HHa-1) received at least 12 hours of in-services each year, resulting in the potential for un-met care needs and poor patient outcomes. Findings include: During record review on 5/30/25, it was discovered that HHa-1’s record failed to document any in-services for any year of employment since their hire date of 3/25/2018. During an interview on 5/30/25 at 1:35 p.m., the administrator (ADM-1) and the Director of Nursing (DON-1) acknowledged the above findings, and ADM-1 stated, “HHA-1 is contracted, we do not in-service them, their staffing agency takes care of that.””

“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 ensure Skilled Nursing provided adequate patient care instructions for the home health aide (HHa) regarding patient needs and safety precautions prior to the provision of care in 1 (Patient/P-1) of 1 record reviewed with HHa services ordered, from a total of 7 sampled records reviewed, resulting in the potential for unmet care needs and poor clinical outcomes for this patient. Findings include: This patient (P-1) was admitted to the home care Agency on 5/13/24, with diagnoses that included pressure ulcer (Stage-2) of sacral region, hemiplegia affecting left side of the body, COPD (chronic obstructive pulmonary disease), use of supplemental oxygen, and hypertension. The Plan of Care (POC/485) ordered aide services once weekly times 8 weeks. Skilled Nursing (SN) who created the aide POC effective 5/13/24, only included 4 of 15 safety precautions found on the POC/485, notably aspiration precautions, fall precautions, and to be wary of the combination of active smoking along with the use of oxygen. The aspiration precaution is significant due to documentation noted in the physician referral for home care which documented the following: “Patient is a 67-year-old paraplegic male with multiple recent admissions to (hospital)... CT scan revealed possible lung aspiration.” The Administrator reviewed and acknowledged the above findings during an interview on 5/30/25 at 12:25 PM.”

“Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) 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: (1) The patient’s current health, psychosocial, functional, and cognitive status; This Element is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the comprehensive assessment accurately reflected the patient’s current health status for 1 (Patient/P-1) of 7 records reviewed, resulting in incomplete clinical information to aid in determining the needs of this patient and for measuring the patient’s progress toward goals/outcomes. Findings include: This patient (P-1) was admitted to the home care Agency on 5/13/24, with diagnoses that included pressure ulcer (Stage-2) of sacral region, hemiplegia affecting left side of the body, COPD (chronic obstructive pulmonary disease), use of supplemental oxygen, and hypertension. On 5/28/25, review of the referral for home care noted P-1 was admitted to the hospital on 5/4/24 for worsening COPD symptoms and discharged on 5/10/25. The physician referral documented the following pertinent clinical findings: “Patient is a 67-year-old paraplegic male with multiple recent admissions to (hospital)... severe COPD on 3 L (liters) of O2 (oxygen).” Documentation also noted P-1 had a blood oxygen level of 85% on 3 L of oxygen and a CT scan revealed possible lung aspiration. History noted paraplegia due to mechanical fall in 2019, and supplemental oxygen use while being a current smoker. Further review of P-1’s initial comprehensive assessment (ICA) performed by Skilled Nursing (SN), noted no detailed history of oxygen saturation levels with or without activity despite significant history requiring hospitalization. No oxygen precautions were mentioned in the ICA and SN marked “No safety risks noted” despite P-1 still using oxygen while smoking. No evidence was found within the assessment which acknowledged recent hospitalizations or the events that led up to admission to the home care Agency. The Administrator reviewed and acknowledged the above findings during an interview on 5/30/25 at 12:20 PM.”

“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 patient’s medication reconciliation was updated and revised within 48 hours of the patient’s return to home following hospitalization for 1 (Patient/P-1) of 1 record reviewed with a ROC (resumption of care) visit post-hospitalization, out of a total sample of 7 records reviewed, resulting in unaccounted new medications with no review for potential severe drug to drug interactions and poor clinical outcomes. Findings include: This patient (P-1) was admitted to the home care Agency on 5/13/24, with diagnoses that included pressure ulcer (Stage-2) of sacral region, hemiplegia affecting left side of the body, COPD (chronic obstructive pulmonary disease), use of supplemental oxygen, and hypertension. On 5/28/25, record review revealed P-1 was transferred to the hospital for pneumonia on 5/18/24 and discharged on 6/5/24. Review of hospital discharge records noted under “Your Home Medication List” the following new medications: Prednisolone (anti-inflammatory) 4 mg., Breo-Ellipta (helps lesson COPD symptoms) 100 mcg-25 mcg., Lasix (diuretic) dosage change of 20 mg. to 40 mg., Atorvastatin (lowers cholesterol 40mg. to 10mg., DuoNeb (respiratory treatment) 0.5-2.5 mg/3 ml., Thiamine (B-1 vitamin) 100 mg., Magnesium hydroxide (treat constipation symptoms) 8% oral suspension, and Neurontin (treats nerve pain) 300 mg. None of these medications prescribed by the physician during hospitalization and to be continued at home were evidenced in P-1’s medical record. The Administrator reviewed and acknowledged the above findings during an interview on 5/30/25 at 12:30 PM. The Agency failed to ensure the comprehensive assessment was updated and revised within 48 hours of the patient’s return home post discharge from the hospital.”

“Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient’s mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This Element is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the plan of care failed to include safety precautions, safety parameters concerning blood oxygen levels, and objectively measurable goals specific to the individualized needs of the patient in 5 (P-1, 4, 5, 6, 7) records, from a total of 7 sampled records reviewed, resulting in the potential for poor patient outcomes and unmet care needs. Findings include: Patient #4’s (P-4) start of care (SOC) was 4/5/25, with diagnoses of arrythmia, tachycardia, heart failure, and diabetes. The plan of care (POC) dated 4/5/25, had skilled nursing ordered for 1 visit a week for 3 weeks, and physical therapy ordered for 2 visits a week for 6 weeks then 1 visit a week for 1 week. During record review on 5/30/25, it was discovered that the goals on the POC were not measurable. One goal stated, “Patient will attain optimal effectiveness of paint management regimen by 3 weeks. Another stated, “Patient/Caregiver demonstrate ability to effectively manage medication regimen by 2 weeks.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. Patient #5’s (P-5) SOC was 5/15/25, with diagnoses of hypertension, pain, and sciatica. The POC dated 5/15/25, had skilled nursing ordered for 1 visit a week for 3 weeks, and physical therapy ordered for 1 visit a week for 1 week, then 2 visits a week for 6 weeks. During record review on 5/30/25, it was discovered that the goals on the POC were not measurable. One goal stated, “Patient/Caregiver will demonstrate competence with self-management of chronic obstructive pulmonary disease (COPD) as evidenced by adherence to medication regimen, ability to identify signs and symptoms necessitating contact with medical professionals, diet regimen guidelines, activity compliance, and symptom management by 3 weeks. Another stated, “Patient will demonstrate compliance with medication regimen as evidenced by correct administration, reporting side effects or adverse reactions by 3 weeks.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. Patient #6’s (P-6) SOC was 4/22/25, with diagnoses of COPD, radiculopathy, and myocardial infarction. The POC dated 4/22/25, had skilled nursing ordered for 1 visit a week for 4 weeks, and physical therapy ordered for 1 visit a week for 1 week, 2 visits a week for 6 weeks, and 1 visit a week for 1 week. During record review on 5/29/25, it was discovered that the goals on the POC were not measurable. One goal stated, “Patient/Caregiver will demonstrate competence with self-management of chronic obstructive pulmonary disease (COPD) as evidenced by adherence to medication regimen, ability to identify signs and symptoms necessitating contact with medical professionals, diet regimen guidelines, activity compliance, and symptom management by 3 weeks. Another stated, “Patient/Caregiver demonstrate ability to effectively manage medication regimen by 3 weeks.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. The POC for P-6 also failed to document anticoagulant/bleeding precautions with an order for Eliquis (Anticoagulant). Patient #7’s (P-7) SOC was 2/1/24, with diagnoses of COPD, shortness of breath, hypertension and diabetes. The POC dated 2/1/24, had skilled nursing ordered for 1 visit a week for 5 weeks, and physical therapy ordered for 1 visit a week for 1 week, 2 visits a week for 6 weeks, and 1 visit a week for 1 week. During record review on 5/28/25, it was discovered that the goals on the POC were not measurable. One goal stated, “Patient will demonstrate steps to protect oneself and others from COVID-19 infection throughout certification period. Another stated, “Patient’s activity level will improve due to effective pain control within 4 weeks.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. During an interview on 5/30/25 at 1:35 p.m., the Administrator (ADM-1) and the Director of Nursing (DON-1) acknowledged the above findings. This patient’s (P-1) start of care to the home care Agency was on 5/13/24, with diagnoses that included pressure ulcer (Stage-2) of sacral region, hemiplegia affecting left side of the body, COPD (chronic obstructive pulmonary disease), use of supplemental oxygen, and hypertension. The Plan of Care (POC) dated 5/13/24, ordered skilled nursing (SN) visits twice weekly times 8 weeks and physical therapy to evaluate and treat. On 5/29/25, record review noted the POC failed to include oxygen safety precautions despite documentation in the physician referral for home care that showed P-1 is an active smoker. In addition, P-1 has a significant history for respiratory issues that required multiple hospitalizations within the last 2 years and supplemental oxygen needs. The POC had no blood oxygen level safety parameters in which to notify the physician if P-1 experienced any shortness in breath or difficulty in breathing. Further record review noted that 4 of 4 SN goals on the POC were not measurable. Examples include: “Patient will have promotion of healing and restoration of skin integrity without complications by/within time-period; Patient/Caregiver will demonstrate ability to effectively manage medication regimen by/within time-period.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. The Administrator reviewed and acknowledged the above findings during an interview on 5/30/25 at 12:35 PM.”

“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 services were provided only as ordered by the physician in 1 (Patient/P-1) of a total sample of 7 records reviewed, resulting in the potential to negatively affect all 11 patients currently serviced by the Agency. Findings include: This patient (P-1) was admitted to the home care Agency on 5/13/24, with diagnoses that included pressure ulcer (Stage-2) of sacral region, hemiplegia affecting left side of the body, COPD (chronic obstructive pulmonary disease), use of supplemental oxygen, and hypertension. The Plan of Care (POC) dated 5/13/25, ordered skilled nursing (SN) visits twice weekly times 8 weeks and physical therapy to evaluate and treat. On 5/29/25, record review noted the POC ordered the following: “SN (Skilled Nursing) to perform wound care as follows: SACRAL: Cleanse wound with wound cleanser applied collagen dressing, covered with mepilex border.” (sic) Further record review found SN/LPN-1 provided wound care treatment on 6/8/24 and again on 6/12/24. LPN-1 documented on the 6/8/24 visit under “Treatments Performed” the following: “Dry skin areas cleansed wound with noormal saline applied Tetracyte 3% and petroleum gauze 2x2 dressing cleaned buttocks, dru, pink and intact skin with normal saline, pat dry, applied meta honey protroleum gauze and covered with 3x5 gauze secured with tape.” (sic) LPN-1 documented on the 6/12/24 visit under “Treatments Performed” the following: “Dry skin areas cleansed wound with noormal saline applied Tetracyte 3% and petroleum gauze 2x2 dressing cleaned buttocks, dru, pink and intact skin with normal saline, pat dry, applied meta honey protroleum gauze and covered with 3x5 gauze secured with tape.” (sic) The Administrator (Adm-1) reviewed and acknowledged the above findings during an interview on 5/30/25 at 12:40 PM. Adm-1 was then queried if the medical record had any orders which authorized LPN-1 to perform wound as documented above. Adm-1 stated, “I don’t see an order in our records.” Adm-1 noted that LPN-1 no longer works with the Agency since last summer.”

“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 promptly notified of an SCIC (significant change in condition) for 1 (Patient/P-1) of 7 records reviewed, resulting in the potential to negatively affect the health and well-being of this patient. Findings include: This patient (P-1) was admitted to the home care Agency on 5/13/24, with diagnoses that included pressure ulcer (Stage-2) of sacral region, hemiplegia affecting left side of the body, COPD (chronic obstructive pulmonary disease), use of supplemental oxygen, and hypertension. On 5/29/25, record review revealed P-1 was transferred to the hospital for pneumonia on 5/18/24 and discharged on 6/5/24. Review of hospital discharge records noted the need for P-1 to be weighed daily and to “report weight gain more than 2 pounds in a 24-hour period or 5 pounds within a week... increased swelling in your ankles, legs or stomach/abdomen.” P-1 had a ROC (resumption of care) visit performed on 6/6/24 by Skilled Nursing (SN), who is also the Agency’s DON (Director of Nursing). Record review from admission through 6/6/24 noted no edema (swelling) of any kind concerning P-1. However, a visit performed by SN (LPN-1) on 6/8/24 documented the following under “Visit Narrative”: “Complains of shortness in breath (SOB) at rest... +3 pitting edema (swelling) BLE (bilateral lower extremities).” This represented a significant change from the ROC visit on 6/6/24 (no edema) to +3 (+4 being highest level possible) within 48 hours. This finding (+3 edema BLE and SOB) was again found on the next SN visit on 6/12/24. LPN-1 failed to notify the physician or the Agency’s DON concerning the increased swelling for both visits noted above. Further review revealed the last medical record entry was performed by SN on 6/14/24 “Death at Home”. Findings which would explain cause of death were not found in P-1’s medical record. Additional efforts were made to the Wayne county’s coroner’s office which was contacted at on 5/29/25 at 12:44 PM. to ascertain cause of death. The office noted P-1’s death was on file but did not include cause of death. SOM (State of Michigan) vital records stated a report could be purchased once proper forms had been filled out, usually taking a couple of weeks. These findings were reviewed with and acknowledged by the Administrator (Adm-1) during an interview on 5/30/251 at 12:40 PM. Adm-1 noted LPN-1 is no longer working with the Agency since last summer.”

“Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient’s updated comprehensive assessment, and contain information concerning the patient’s progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This Element is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to ensure that the Plan of Care (POC) was updated to reflect the current information from the updated comprehensive assessment in 1 (Patient/P-1) of 1 record reviewed with a ROC (resumption of care) visit post-hospitalization, out of a total sample of 7 records reviewed, resulting in a POC that does not meet the patient’s current clinical needs and the potential for unrecognized lack of progress towards patient centered goals. Findings include: This patient (P-1) was admitted to the home care Agency on 5/13/24, with diagnoses that included pressure ulcer (Stage-2) of sacral region, hemiplegia affecting left side of the body, COPD (chronic obstructive pulmonary disease), use of supplemental oxygen, and hypertension. On 5/29/25, record review revealed P-1 was transferred to the hospital for pneumonia on 5/18/24 and discharged on 6/5/24. Review of hospital discharge records noted the need for P-1 to be weighed daily and to “report weight gain more than 2 pounds in a 24-hour period or 5 pounds within a week... increased swelling in your ankles, legs or stomach/abdomen.” On 6/6/24, a ROC (resumption of care) visit was performed by Skilled Nursing (SN), who is also the Agency’s DON (Director of Nursing). Record review from admission through 6/6/24 noted no edema (swelling) of any kind concerning P-1. However, a visit performed by SN (LPN-1) on 6/8/24 documented the following under “Visit Narrative”: “Complains of shortness in breath (SOB) at rest... +3 pitting edema (swelling) to BLE (bilateral lower extremities).” This represented a significant change from the ROC visit on 6/6/24 (no edema) to a severe +3 (+4 being extreme/highest level possible) within 48 hours. This finding (+3 edema BLE and SOB) was again documented by LPN-1 during the next SN visit on 6/12/24. LPN-1 failed to notify the physician or the Agency’s DON concerning the increased swelling for both visits noted above. Further review noted the last medical record entry was performed by SN/DON on 6/14/24 “Death at Home”. Findings which would explain cause of death were not found in P-1’s medical record. Additional efforts were made to the Wayne county’s coroner’s office which was contacted at on 5/29/25 at 12:44 PM. to ascertain cause of death. The office noted P-1’s death was on file but did not include cause of death. SOM (State of Michigan) vital records stated a report could be purchased once proper forms had been filled out, usually taking a couple of weeks to complete. The Administrator (Adm-1) reviewed and acknowledged the above findings during an interview on 5/30/24 at 12:45 PM. Adm-1 noted LPN-1 is no longer working with the Agency since last summer.”

“Participate in HHA-sponsored in-service CFR(s): 484.75(b)(9) Participation in HHA-sponsored in-service training. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure 1 of 1 contracted home health aides (HHa-1) participated in agency sponsored in-services, resulting in the potential for poor patient outcomes. Findings include: During record review on 5/30/25, it was discovered that HHa-1’s record failed to document any in-services for any year of employment since their hire date of 3/25/2018. During an interview on 5/30/25 at 1:35 p.m., the administrator (ADM-1) and the Director of Nursing (DON-1) acknowledged the above findings and ADM-1 stated, “HHA-1 is contracted, we do not in-service them, their staffing agency takes care of that.””

“Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This Element is not met as evidenced by: Based on record review and interview, the Agency failed to ensure that the home health aide (HHa) plan of care included all pertinent safety precautions for 1 (Patient/P-1) of 1 record reviewed with aide services, out of a total sample of 7 records reviewed, resulting in the potential for unmet care needs and poor clinical outcomes for this patient. Findings include: This patient (P-1) was admitted to the home care Agency on 5/13/24, with diagnoses that included pressure ulcer (Stage-2) of sacral region, hemiplegia affecting left side of the body, COPD (chronic obstructive pulmonary disease), use of supplemental oxygen, and hypertension. The Plan of Care (POC/485) ordered aide services once weekly times 8 weeks. Skilled Nursing (SN) who created the aide POC effective 5/13/24, only included 4 of 15 safety precautions found on the POC/485, notably aspiration precautions, fall precautions, and to be wary of the combination of active smoking along with the use of oxygen. The aspiration precaution is significant due to documentation noted in the physician referral for home care which documented the following: “Patient is a 67-year-old paraplegic male with multiple recent admissions to (hospital)... CT scan revealed possible lung aspiration.” The Administrator reviewed and acknowledged the above findings during an interview on 5/30/25 at 12:25 PM.”

“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 transfer summary was complete in 1 (Patient/P-1) of 1 record reviewed with a transfer, out of a total of 7 records reviewed, resulting in the potential for unidentified continuing health care concerns and unmet care needs. Findings include: This patient (P-1) was admitted to the home care Agency on 5/13/24, with diagnoses that included pressure ulcer (Stage-2) of sacral region, hemiplegia affecting left side of the body, COPD (chronic obstructive pulmonary disease), use of supplemental oxygen, and hypertension. On 5/29/25, record review revealed patient (P-1) was transferred to the hospital for pneumonia on 5/18/24 with the transfer summary being sent to the physician on 5/20/24. However, review of the content of the transfer summary noted numerous key areas being left blank which are as follows: “Allergies”, “Vital Signs Ranges”, “Patient Goals”, “Goal Attainment Rate”, “Oxygen Saturation”, “Pain Levels”, “Disciplines and Frequency of Visits”, “Total Visits Provided” and “Reason for Admission to Home Health/Continued Services”. The Administrator (Adm-1) reviewed and acknowledged the above findings during an interview on 5/30/251 at 12:45 PM. Adm-1 noted the transfer summary should have included more information.”