Caring Home Health Agency, LLC

“Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient’s rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This Condition is not met as evidenced by: Based on record review and interview, the agency failed to ensure the administrator’s name and contact information related to complaint and grievance procedures for the agency was a part of the admission packet information for all patients. The failed practice had the potential to affect the ability for all patients, caregivers, family members and staff to effectively communicate complaints and grievances to the administrator of the HHA. See tag G414. Based on record reviews and interview, the agency failed to ensure patients’ rights to have completed assessments, participate in the establishment and revision of a plan of care and be informed of disciplines to provide services with expected frequencies of visits for seven (Patients #1, 2, 3, 4, 5, 6 and #9) of nine patients. The failed practice had the potential to violate the patient rights to have a comprehensive assessment and to participate in the planning of services and care for all patients. See Tag G434. Based on record review and interview, the agency failed to ensure OSDH complaint hotline contact information was included as a part of the agency’s grievance and complaint procedures for all patients. The failed practiced had the potential to hinder the abilities of patients, caregivers, family members and staff to report complaints, incidents or grievances with the agency. See Tag G444. .”

“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, the agency failed to ensure a recertification (updated comprehensive [OASIS]) assessment was completed for six (Patients #1, 2, 3, 4, 5 and #9) of nine patients. The failed practice had the potential to impact the care and services required to meet the patient’s health care needs and outcomes for all patients. See Tag G546. Based on record review and interview the agency failed to ensure a discharge oasis was completed by the agency for one (Patients #8) of nine patients. The failed practice had the potential to impact the coordination of follow up care needs and services affecting patient outcomes for all patients. See Tag G550. .”

“Discharge Planning CFR(s): 484.58 Condition of Participation: Discharge planning. This Condition is not met as evidenced by: Based on record review and interview, the agency failed to ensure development, implementation and update of individualized patient POCs by the designated administrator/clinical manager (Staff B) for the agency for seven (Patients #1, 2, 3, 4, 5, 6 and #9) of nine patients and all employees. The failed practice affected the agency’s ability to effectively provide appropriate care and services ordered by the physician to its patients. See Tag G562. Based on record reviews and interview, the agency failed to ensure a transfer/discharge summary was completed at the time of patient transfer/discharge for three (Patients #3, 7 and #8) of nine patients. The failed practice had the potential to affect care transition outcomes as patients move through different levels of care to meet their healthcare needs for all patients. See Tag G564. .”

“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 development of an episodic Plan of Care after a comprehensive OASIS assessment for seven (Patients #1, 2, 3, 4, 5, 6 and #9) of nine patients. The failed practice had the potential to affect the ability of the agency to identify and address a patient’s health care needs and interventions to achieve health improvements and outcomes for all patients. See Tag G572. Based on record review and interview, the agency failed to ensure an individualized patient POC included weight reporting parameters for one (Patient #2) of nine patients. The failed practice had the potential to affect a patient’s response to health care interventions to achieve functional and physical health improvements for all patients. See Tag G 574. Based on record reviews and interview, the agency failed to ensure resumption of care SN visit was ordered by the physician for one (Patient #3) of nine patients. The failed practice had the potential to impact the health, safety and well-being of patients by receiving care and services not ordered by their physician for all patients. See Tag G580. Based on record review and interview, the agency failed to ensure timely notification and physician opportunity to review and revise individualized POCs every 60 days for eight (Patients #1, 2, 3, 4, 5, 6, 7 and #9) of nine patients. The failed practice had the potential to affect the health and health care outcomes of all patients that required skilled care interventions to improve their health status. See Tag #G588. Based on record review and interview, the agency failed to ensure a designation of the clinical manager and/or supervising RN contact information for the agency was included in patient information packet for all patients and employees. The failed practice impeded the patient and/or caregivers’ ability to contact the agency with complaints, incidents or grievance related to their provision of care and services by the agency. See Tag G622. .”

“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 record review and interview, the agency failed to ensure evidence of patient centered QAPI Program activities for all patients and employees. The failed practice had the potential to place all patients and employees at risk for insufficient self-monitoring and efforts to improve care, services and operations. See Tag G642. Based on record review and interview, the agency failed to ensure utilization of OASIS quality indicator source data to improve program effectiveness, quality of patient care and overall program improvement for all patients and employees. The failed practice had the potential to place all patients at risk of repeated agency mishaps, ineffective management of care and poor quality of care. See Tag #G644 Based on record review and interview, the agency failed to ensure conduction of patient centered QAPI Program activities that included self-monitoring efforts and opportunities that tracked adverse events, analyzed causes and implemented actions to identify problems to improve care, services and operations for all patients and employees. The failed practice had the potential to place the agency, its patients and all employees at risk for stagnated efforts for improvement as a result of unidentified problematic clinical, administrative, infection control or personnel problems. See Tag #G654. Based on record review and interview, the agency failed to ensure governing body oversite of the conduction of patient centered QAPI Program activities which included sources of data, analysis of data and implementation of actions which tracked efforts toward improvement of care and services for all patients and employees. The failed practice had the potential to place all patients and employees at risk for insufficient governing body oversite of agency services and operations. See Tag G660. .”

“Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This Condition is not met as evidenced by: Based on record review and interview, the agency failed to ensure its infection control program included surveillance monitoring and reporting and was included in QAPI program activities for all patients and staff. The failed practice placed the agency at risk for missed opportunities to identify and reduce the incidence and occurrence of infection throughout the agency and affect the health and well-being of all patients and employees. See Tag G684. Based on record review and interview, the agency failed to show infection control education was: 1. Included in QAPI activities; 2. Showed interventions to reduce future infections; and 3. Provided and/or maintained infection control education for all patients and employees. The failed practiced placed the agency at risk for missed opportunities to identify and correct substandard practices and reduced opportunities to create learning throughout the agency for all patients and employees. See Tag G686. .”

“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 record review and interview, the agency failed to ensure governing body oversite of management and operations of the agency for provisions of care and services, patient safety, budget planning, allocation of resources, QAPI program planning and annual agency program evaluation for calendar years 2022 and 2023 for all patients and employees. The failed practice had the potential to impact the care and services provided by the agency in the communities that it serves. See Tag G942. Based on record review and interview, the agency failed to ensure governing body appointment of an administrator for the agency effecting all patients and employees. The failed practice had the potential to affect the care services provided by the agency impacting subsequent care outcomes of the patients. See Tag G954. Based on record review and interview, the agency failed to ensure development, implementation and update of individualized patient POCs by the designated administrator/clinical manager for the agency for seven (Patients #1, 2, 3, 4, 5, 6 and #9) of nine patients and all employees. The failed practice affected the agency’s ability to effectively provide appropriate care and services to its patients. See Tag G968. Based on record review and interview, the agency failed to ensure governing body fiscal planning and oversite of an operating budget and capital expenditure plan for calendar years 2022 and 2023 for all patients and employees. The failed practice affected the agency’s ability to effectively operate and provide services to its patients and the community at large. See Tag G988. .”

“Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(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 the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. *[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. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This Standard is not met as evidenced by: Based on record review and interview the agency failed to ensure a facility and community-based risk assessment (All Hazards Risk Assessment) was developed and implemented for all patients and employees. Findings: An agency policy, titled Emergency Preparedness, stated the HHA must develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually. The plan is based on and include a documented facility and community based risk assessment utilizing an all hazards approach. A review of administrative records showed no facility and community-based risk assessment for the agency, its patient population, or its employees. On 02/21/24 at 2:00 p.m., Staff B stated the agency did not develop and implement an All Hazards Risk Assessment.”

“Local, State, Tribal Collaboration Process CFR(s): 484.102(a)(4) §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.542(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure development, implementation and maintenance of processes and contact information for an integrated emergency preparedness response with Federal, State, Tribal, Regional and Local emergency management officials for all patients and employees. Findings: An agency policy, titled Emergency Preparedness, stated the HHA must develop and maintain an emergency preparedness plan that include processes for cooperation and collaboration with local, state, regional, state and federal emergency preparedness officials to maintain an integrated response. A review of administrative records showed no administrative processes and/or resource contact information for an integrated emergency preparedness response with Federal, State, Tribal, Regional and Local emergency management officials for the agency. On 02/21/24 at 2:00 p.m., Staff B stated the agency did not have an Emergency Preparedness Plan with administrative processes and resource contact information for an integrated emergency preparedness response with Federal, State, Tribal, Regional and Local emergency management officials.”

“Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(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 facilities]. 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 and interview, the agency failed to ensure an Emergency Preparedness Communication Plan included updated required information related to the staff and contracted service providers contact information for the agency for all patients and staff. Findings: An agency policy, titled Emergency Preparedness, stated the HHA Emergency Preparedness communication plan [the agency] must review and update at least annually names and contact information of staff, entities providing services under contract and patient physician’s. A review of administrative records showed no updated Emergency Preparedness Communication Plan which included current staff contact information for the agency. On 02/21/24 at 2:00 p.m., Staff B stated the Emergency Preparedness Communication Plan was not updated to include contact information for current staff for the agency.”

“EP Training and Testing CFR(s): 484.102(d) §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(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, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and 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 facilities 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 and interview, the agency failed to ensure: 1. An emergency preparedness testing and training program was developed, implemented and reviewed/updated at least annually for all patients and employees and; 2. An after action report was documented after each drill, exercise or plan activation event for all patients and employees. Findings: An agency policy, titled Emergency Preparedness Operational Plan, stated Caring Home Health must analyze their [its] response and maintain documentation of all drills, exercises and events and revise their emergency plan as needed. A response summary in narrative form will be provided to the QAPI committee for review to evaluate performance. All staff will receive training on the emergency preparedness plan on hire and at a minimum annually. A review of administrative records showed no documentation an emergency preparedness plan testing and training program was developed, implemented and reviewed/updated at least annually. Documentation showed no after action reports were documented after each drill, exercise or plan activation event that summarized and evaluated the agency’s responses. On 02/21/24 at 2:00 p.m., Staff B stated: 1. The agency had no emergency preparedness plan testing and training program and; 2. The agency showed no after action reports were documented after each drill, exercise or plan activation event that summarized and evaluated the agency’s responses.”

“Discharge Planning CFR(s): 484.58(a) Standard: Discharge planning. An HHA must develop and implement an effective discharge planning process. For patients who are transferred to another HHA or who are discharged to a SNF, IRF or LTCH, the HHA must assist patients and their caregivers in selecting a post-acute care provider by using and sharing data that includes, but is not limited to HHA, SNF, IRF, or LTCH data on quality measures and data on resource use measures. The HHA must ensure that the post-acute care data on quality measures and data on resource use measures is relevant and applicable to the patient’s goals of care and treatment preferences. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure development, implementation and update of individualized patient POCs by the designated administrator/clinical manager (Staff B) for the agency for seven (Patients #1, 2, 3, 4, 5, 6 and #9) of nine patients and all employees. The failed practice affected the agency’s ability to effectively provide appropriate care and services ordered by the physician to its patients. Findings: On 02/20/24 at 9:15 a.m., an announced on-site visit to the agency was conducted for survey purposes. Lists of active patients and discharged patient in the last six months were requested. A review of administrative records showed documentation that six (Patients #1, 2, 3, 4, 5 and #6) of six active patients and three (Patients #7, 8 and #9) of seven patients discharged in the last six months were selected for the survey sample. Clinical record documentation showed that seven (Patients 1, 2, 3, 4, 5, 6 and #9) of nine patients had no individualized POCs for one or more 60 day certification periods for each Home Health episodic periods. See Tag G572. Administrative records which showed operational oversight of the agency by the administrator/clinical manager (Staff B) in 2022 and 2023 and agency case conference and/or discharge planning coordination reports for all nine (Patients 1, 2, 3, 4, 5, 6, 7, 8 and #9) survey sample patients were requested. No documentation was provided. On 02/21/24 at 1:45 p.m., Staff B stated: 1. There was no documentation which showed operational oversight of the agency by the administrator/clinical manager (Staff B) for 2022 and 2023 and; 2. The agency had no case conference and/or discharge planning coordination reports that ensured documentation of the development, implementation and update of individualized patient POCs for all patients by the designated administrator/clinical manager (Staff B) for the agency.”

“Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient’s current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This Standard is not met as evidenced by: Based on record reviews and interview, the agency failed to ensure a transfer/discharge summary was completed at the time of patient transfer/discharge for three (Patients #3, 7 and #8) of nine patients. The failed practice had the potential to affect care transition outcomes as patients move through different levels of care to meet their healthcare needs for all patients. Findings: An agency policy, titled “Protocols for Home Health Care,” stated all patients admitted to the hospital must have a transfer OASIS and the agency is required to submit a transfer summary with details of the patient’s care to the physician and the hospital [entity] that receives the [patient] within 48 hours of notification of the transfer to the agency. Patients discharged from the agency must have a discharge OASIS assessment and a discharge summary must be sent to the physician within 5 days of the discharge date. Patient #3 A review of the clinical record showed documentation the patient was transferred to inpatient hospital provider services on 12/26/23. Documentation showed no transfer summary was completed, provided to the physician of record or the inpatient hospital service provider. Patient #7 A review of the clinical record showed documentation the patient was transferred to inpatient hospital provider services on 07/25/23. Documentation showed no transfer summary was completed, provided to the physician of record or the inpatient hospital service provider. Patient #8 A review of the clinical record showed documentation the patient was discharged on 10/10/23. Documentation showed no discharge summary was completed, provided to the physician of record. Patient #9 A review of the clinical record showed documentation the patient was discharged on 09/07/23. Documentation showed no discharge summary was completed, provided to the physician of record. On 02/21/24 between 2:00 to 2:30 p.m., Staff B stated: 1. Patients #3 and #7 had no transfer summary completed or provided to the physician of record or the inpatient hospital service provider and; 2. Patients #8 and #9 had no discharge summary completed or provided to the physician of record.”

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure development of an episodic certification Plan of Care for seven (Patients #1, 2, 3, 4, 5, 6 and #9) of nine patients. The failed practice had the potential to affect the ability of the agency to identify and address a patient’s health care needs and interventions to achieve health improvements and outcomes for all patients. Findings: Patient #1 A review of the clinical record showed no documentation of physician orders (episodic POCs) for POC certification periods of 12/07/23 to 02/04/24 and 02/05/24 to 04/04/24. Documentation showed no physician notifications and no recertification OASIS assessments conducted between 12/02/23 to 02/03/24 and 01/31/24 to 02/04/24 (days 55 through 60 of each 60 day certification period) and documented no physician orders. The last documented POC for the patient’s Home Health Agency episodic certification period was 10/08/23 to 12/06/23. On 02/21/24 from 2:00 to 2:30 p.m., Staff B stated: 1. Patient #1 did not have POCs (physician orders) for the certification periods of 12/07/23 to 02/04/24 and 02/05/24 to 04/04/24; 2. The patient was not discharge from agency services and; 3. The patient may have received agency services without physician orders as the assigned SN had not submitted any SN visit notes since 09/14/23 (date of last known SN visit documented in the clinical record). Patient #2 A review of the clinical record showed no documentation of physician orders (episodic POCs) for POC certification periods of 01/06/24 to 03/05/24. Documentation showed no physician notifications and no recertification OASIS assessments conducted between 01/01/24 to 01/05/24 (days 55 through 60 of each 60 day certification period) and documented no physician orders. The last documented POC for the patient’s Home Health Agency episodic certification period was 11/07/23 to 01/05/24. On 02/21/24 from 2:00 to 2:30 p.m., Staff B stated: 1. Patient #2 did not have POCs (physician orders) for the certification periods of 01/06/24 to 03/05/24; 2. The patient was not discharge from agency services and; 3. The patient may have received agency services without physician orders as the assigned SN had not submitted any SN visit notes since 10/06/23 (date of last known SN visit documented in the clinical record). Patient #3 A review of the clinical record showed no documentation of physician orders (episodic POCs) for POC certification periods of 11/09/23 to 01/07/24 and 01/08/24 to 03/07/24. Documentation showed no physician notifications and no recertification OASIS assessments conducted between 11/04/23 to 11/08/24 (days 55 through 60 of the 60 day certification period) and showed a resumption of care OASIS assessment conducted on 01/04/24 but showed no subsequent POC and documented no physician orders. The last documented POC for the patient’s Home Health Agency episodic certification period was 09/10/23 to 11/08/23. On 02/21/24 from 2:00 to 2:30 p.m., Staff B stated: 1. Patient #3 did not have POCs (physician orders) for the certification periods of 11/09/23 to 01/07/24 and 01/08/24 to 03/07/24; 2. The patient was not discharge from agency services and; 3. The patient may have received agency services without physician orders as the assigned SN had not submitted any SN visit notes prior to and since the ROC OASIS on 01/04/24 (date of last known SN visit documented in the clinical record). Patient #4 A review of the clinical record showed no documentation of physician orders (episodic POCs) for POC certification periods of 02/18/24 to 04/17/24. Documentation showed no physician notifications and no recertification OASIS assessments conducted between 02/13/24 to 02/17/24 (days 55 through 60 of each 60 day certification period) and documented no physician orders. The last documented POC for the patient’s Home Health Agency episodic certification period was 12/20/23 to 02/17/24. On 02/21/24 from 2:00 to 2:30 p.m., Staff B stated: 1. Patient #4 did not have POCs (physician orders) for the certification period of 02/18/24 to 04/17/24; 2. The patient was not discharge from agency services and; 3. The patient may have received agency services without physician orders as the assigned SN had not submitted any SN visit notes since the recertification OASIS assessment on 12/18/23 (date of last known SN visit documented in the clinical record). Patient #5 A review of the clinical record showed no documentation of physician orders (episodic POCs) for POC certification periods of 11/16/23 to 01/14/24. Documentation showed no physician notifications and no recertification OASIS assessments conducted between 11/11/23 to 11/15/23 (days 55 through 60 of each 60 day certification period) and documented no physician orders. The last documented POC for the patient’s Home Health Agency episodic certification period was 01/15/24 to 03/14/24. On 02/21/24 from 2:00 to 2:30 p.m., Staff B stated: 1. Patient #5 did not have POCs (physician orders) for the certification periods of 11/16/23 to 01/14/24; 2. The patient was not discharge from agency services and; 3. The patient may have received agency services without physician orders as the assigned SN had not submitted any SN visit notes since 09/27/23 (date of last known SN visit documented in the clinical record). Patient #6 A review of the clinical record showed no documentation of physician orders (episodic POCs) for POC certification periods of 01/25/24 to 03/24/24. Documentation showed no physician notifications and documentation showed a recertification OASIS assessments conducted on 01/22/24 and documented no physician orders. The last documented POC for the patient’s Home Health Agency episodic certification period was 11/26/23 to 01/24/24. On 02/21/24 from 2:00 to 2:30 p.m., Staff B stated: 1. Patient #5 did not have POCs (physician orders) for the certification periods of 01/25/24 to 03/24/24; 2. The patient was not discharge from agency services and; 3. The patient may have received agency services without physician orders as the assigned SN had not submitted any SN visit notes since 09/14/23 (date of last known SN visit documented in the clinical record). Patient #9 A review of the clinical record showed no documentation of physician orders (episodic POCs) for POC certification periods of 08/24/23 to 09/07/23 (date of discharge from agency services). Documentation showed no physician notifications and no recertification OASIS assessments conducted between 08/19/23 to 08/23/23 (days 55 through 60 of each 60 day certification period) and documented no physician orders. The last documented POC for the patient’s Home Health Agency episodic certification period was 06/25/23 to 08/23/23. On 02/21/24 from 2:00 to 2:30 p.m., Staff B stated: 1. Patient #9 did not have POCs (physician orders) for the certification period of 08/24/23 to 09/07/23 (date of discharge from agency services) and; 2. The patient may have received agency services without physician orders as the assigned SN had not submitted any SN visit notes since 07/28/23 (date of last known SN visit documented in the clinical record).”

“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, the agency failed to ensure evidence of patient centered QAPI Program activities for all patients and employees. The failed practice had the potential to place all patients and employees at risk for insufficient self-monitoring and efforts to improve care, services and operations. Findings: An agency policy, titled, “Quality Assessment and Performance Improvement,” stated the HHA must develop, implement, evaluate and maintain a QAPI program. The program’s scope must demonstrate measurable improvements, the program data must be collected and tracked and program activities must track adverse patient events, analyze their causes and implement preventative actions. A review of agency QAPI Program documents showed no quarterly QAPI program meeting activities which showed measurements, analysis, tracking or evaluation of data (scope) for the agency’s improvement in calendar years 2022 and 2023. On 02/21/24 at 1:30 p.m., Staff C stated: 1. The agency prepared quarterly reports based on limited data (clinical patient record chart audits) during calendar years 2022 and 2023; and 2. Documentation showed no improvement measurements, analysis, tracking or evaluation of data (program scope) by the agency.”

“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 ensure utilization of OASIS quality indicator source data to improve program effectiveness, quality of patient care and overall program improvement for all patients and employees. The failed practice had the potential to place all patients at risk of repeated agency mishaps, ineffective management of care and poor quality of care. Findings: A review of QAPI records for calendar years 2022 and 2023 showed no data collection sources based on OASIS quality indicator data or activities utilized in the analysis of that data in the agency’s QAPI Program for calendar years 2022 and 2023. On 02/21/24 at 1:30 p.m., Staff C stated: 1. All available QAPI program documentation for the agency was provided in its entirety and; 2. Documentation showed no program improvement data or analysis of collected data based on OASIS quality indicator data for calendar years 2022 and 2023.”

“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 ensure conduction of patient centered QAPI Program activities that included self-monitoring efforts and opportunities that tracked adverse events, analyzed causes and implemented actions to identify problems to improve care, services and operations for all patients and employees. The failed practice had the potential to place the agency, its patients and all employees at risk for stagnated efforts for improvement as a result of unidentified problematic clinical, administrative, infection control or personnel problems. Findings: A review of QAPI Program documents showed no program activities for calendar year 2022 and 2023 that included self-monitoring efforts and opportunities that tracked adverse events, analyzed causes and implemented actions to identify problems to improve care, services and operations. On 02/21/24 at 1:30 p.m., Staff C stated QAPI program documentation for calendar years 2022 and 2023 showed no ongoing QAPI program activities that included self-monitoring efforts and opportunities that tracked adverse events, analyzed causes and implemented actions to identify problems to improve care, services and operations.”

“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 ensure governing body oversite of the conduction of patient centered QAPI Program activities which included sources of data, analysis of data and implementation of actions which tracked efforts toward improvement of care and services for all patients and employees. The failed practice had the potential to place all patients and employees at risk for insufficient governing body oversite of agency services and operations. Findings: An agency policy titled, “Quality Assessment and Performance Improvement,” stated the HHA governing body is responsible to ensure the ongoing QAPI program efforts address priorities for improved quality of care and patient safety and improvement actions are evaluated. A review of administrative records showed no governing body oversite for the conduction of a comprehensive patient centered QAPI Program for calendar years 2022 and 2023. On 02/21/24 at 1:30 p.m., Staff C stated administrative record documentation showed no governing body oversite of the conduction of a comprehensive patient centered QAPI Program in calendar years 2022 and 2023.”

“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 ensure its infection control program included surveillance monitoring and reporting; and was included in QAPI program activities for all patients and staff. The failed practice placed the agency at risk for missed opportunities to identify and reduce the incidence and occurrence of infection throughout the agency and effect the health and well-being of all patients and employees. Findings: An agency policy titled, “Infection prevention and Control” stated the HHA must maintain a coordinated agency wide program for infection surveillance that is an integral part of the QAPI program. A review of QAPI and Infection Control Program documents showed no infection control program surveillance monitoring and reporting as a part of QAPI program activities for calendar years 2022 and 2023. On 02/21/24 at 1:30 p.m., Staff C stated: 1. The agency did not provide the infection surveillance logs and; 2. She was not aware it needed to be part of QAPI program reporting.”

“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, the agency failed to show infection control education was: 1. Included in QAPI activities; 2. Showed interventions to reduce future infections; and 3. Provided and/or maintained infection control education for all patients and employees. The failed practiced placed the agency at risk for missed opportunities to identify and correct substandard practices and reduced opportunities to create learning throughout the agency for all patients and employees. Findings: A review of administrative records showed no documentation of infection control program education or learning activities were provided by the agency to patients and employees and were included in the QAPI program for the agency. On 02/21/24 at 1:30 p.m., Staff C stated there was no documentation of infection control program education or learning activities were: 1. Provided by the agency to patients and employees and; 2. Were included in the QAPI program for the agency.”

“Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency’s overall management and operation, the provision of all home health services, fiscal operations, review of the agency’s budget and its operational plans, and its quality assessment and performance improvement program. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure governing body oversite of management and operations of the agency for provisions of care and services, patient safety, budget planning, allocation of resources, QAPI program planning and annual agency program evaluation for calendar years 2022 and 2023 for all patients and employees. This failed practice had the potential to impact the care and services provided by the agency in the communities that it serves. Findings: An agency policy titled, “Organization and Administration of Services,” stated a governing body assumes full legal authority and responsibility for the agency’s management and operation; and is responsible to review of the agency’s budget, operational plans and its quality assessment and performance improvement program at least annually. A review of administrative records showed no governing body over-site and responsibility for the agency’s operating budget, capital expenditure plan, QAPI program or agency’s annual program evaluation for calendar years 2022 and 2023. On 02/21/24 at 1:45 p.m., Staff B stated documentation showed no administrative records which showed evidence of ongoing governing body oversite and responsibility for the agency’s operating budget, capital expenditure plan, QAPI program or agency annual program evaluation for calendar years 2022 and 2023.”

“Institutional planning CFR(s): 484.105(h) Standard: Institutional planning. The HHA, under the direction of the governing body, prepares an overall plan and a budget that includes an annual operating budget and capital expenditure plan. (1) Annual operating budget. There is an annual operating budget that includes all anticipated income and expenses related to items that would, under generally accepted accounting principles, be considered income and expense items. However, it is not required that there be prepared, in connection with any budget, an item by item identification of the components of each type of anticipated income or expense. (2) Capital expenditure plan. (i) There is a capital expenditure plan for at least a 3-year period, including the operating budget year. The plan includes and identifies in detail the anticipated sources of financing for, and the objectives of, each anticipated expenditure of more than $600,000 for items that would under generally accepted accounting principles, be considered capital items. In determining if a single capital expenditure exceeds $600,000, the cost of studies, surveys, designs, plans, working drawings, specifications, and other activities essential to the acquisition, improvement, modernization, expansion, or replacement of land, plant, building, and equipment are included. Expenditures directly or indirectly related to capital expenditures, such as grading, paving, broker commissions, taxes assessed during the construction period, and costs involved in demolishing or razing structures on land are also included. Transactions that are separated in time, but are components of an overall plan or patient care objective, are viewed in their entirety without regard to their timing. Other costs related to capital expenditures include title fees, permit and license fees, broker commissions, architect, legal, accounting, and appraisal fees; interest, finance, or carrying charges on bonds, notes and other costs incurred for borrowing funds. (ii) If the anticipated source of financing is, in any part, the anticipated payment from title V (Maternal and Child Health Services Block Grant) or title XVIII (Medicare) or title XIX (Medicaid) of the Social Security Act, the plan specifies the following: (A) Whether the proposed capital expenditure is required to conform, or is likely to be required to conform, to current standards, criteria, or plans developed in accordance with the Public Health Service Act or the Mental Retardation Facilities and Community Mental Health Centers Construction Act of 1963. (B) Whether a capital expenditure proposal has been submitted to the designated planning agency for approval in accordance with section 1122 of the Act (42 U.S.C. 1320a-1) and implementing regulations. (C) Whether the designated planning agency has approved or disapproved the proposed capital expenditure if it was presented to that agency. (3) Preparation of plan and budget. The overall plan and budget is prepared under the direction of the governing body of the HHA by a committee consisting of representatives of the governing body, the administrative staff, and the medical staff (if any) of the HHA. (4) Annual review of plan and budget. The overall plan and budget is reviewed and updated at least annually by the committee referred to in paragraph (i)(3) of this section under the direction of the governing body of the HHA. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure governing body fiscal planning and oversite of an operating budget and capital expenditure plan for calendar years 2022 and 2023 for all patients and employees. The failed practice affected the agency’s ability to effectively operate and provide services to its patients and the community at large. Findings: An agency policy titled, “Organization and Administration of Services,” stated a governing body assumes full legal authority and responsibility for the agency’s management and operation; and is responsible to review of the agency’s budget, operational plans at least annually. A review of administrative records showed no governing body fiscal planning and oversite of an operating budget and capital expenditure plan for calendar years 2022 and 2023. On 02/21/24 at 1:45 p.m., Staff B stated documentation showed no administrative records which showed evidence of ongoing governing body fiscal planning and oversite of an operating budget and capital expenditure plan for calendar years 2022 and 2023.”

“HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator’s name, business address, and business phone number in order to receive complaints. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the administrator’s name and contact information related to complaint and grievance procedures for the agency was a part of the admission packet information for all patients. The failed practice had the potential to affect the ability for all patients, caregivers, family members and staff to effectively communicate complaints and grievances to the administrator of the HHA. Findings: A review of administrative records (start of care patient information packet/booklet) showed no agency administrator’s name and contact information related to complaint and grievance procedures for the agency. On 02/21/24 at 11:45 a.m., Staff B reviewed the start of care patient information packet/booklet and stated the administrator’s name and contact information was not in the packet/booklet information given to the patients at the time of admission to the agency.”

“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 reviews and interview, the agency failed to ensure patients’ rights to have completed assessments, participate in the establishment and revision of a plan of care and be informed of disciplines to provide services with expected frequencies of visits for seven (Patients #1, 2, 3, 4, 5, 6 and #9) of nine patients. The failed practice had the potential to violate the patient rights to have a comprehensive assessment and to participate in the planning of services and care for all patients. Findings: Patient #1 A review of the clinical record showed no documentation of physician orders (episodic POCs) for POC certification periods of 12/07/23 to 02/04/24 and 02/05/24 to 04/04/24. Documentation showed no patient/caregiver participation in a comprehensive assessment and establishment of a POC, no physician notification of the conducted comprehensive (recertification) OASIS assessment and documented no physician orders. The last documented POC for the patient’s Home Health Agency episodic certification period was 10/08/23 to 12/06/23. On 02/21/24 from 2:00 to 2:30 p.m., Staff B stated: 1. Patient #1 did not have POCs (physician orders) for the certification periods of 12/07/23 to 02/04/24 and 02/05/24 to 04/04/24; 2. Documentation showed no patient/caregiver participation in a comprehensive assessment and establishment of the POC and ; 3. The patient was not discharge from agency services and the assigned SN had not submitted any SN visit notes since 09/14/23 (date of last known SN visit documented in the clinical record). Patient #2 A review of the clinical record showed no documentation of physician orders (episodic POCs) for POC certification periods of 01/06/24 to 03/05/24. Documentation showed no patient/caregiver participation in a comprehensive assessment and establishment of a POC, no physician notification of the conducted comprehensive (recertification) OASIS assessment and documented no physician orders. The last documented POC for the patient’s Home Health Agency episodic certification period was 11/07/23 to 01/05/24. On 02/21/24 from 2:00 to 2:30 p.m., Staff B stated: 1. Patient #2 did not have POCs (physician orders) for the certification periods of 01/06/24 to 03/05/24; 2. Documentation showed no patient/caregiver participation in a comprehensive assessment and establishment of the POC and; 3. The patient was not discharge from agency services and the assigned SN had not submitted any SN visit notes since 10/06/23 (date of last known SN visit documented in the clinical record). Patient #3 A review of the clinical record showed no documentation of physician orders (episodic POCs) for POC certification periods of 11/09/23 to 01/07/24 and 01/08/24 to 03/07/24. Documentation showed no patient/caregiver participation in a comprehensive assessment and establishment of a POC, no physician notification of the conducted comprehensive (recertification) OASIS assessment and documented no physician orders. The last documented POC for the patient’s Home Health Agency episodic certification period was 09/10/23 to 11/08/23. On 02/21/24 from 2:00 to 2:30 p.m., Staff B stated: 1. Patient #3 did not have POCs (physician orders) for the certification periods of 11/09/23 to 01/07/24 and 01/08/24 to 03/07/24; 2. Documentation showed no patient/caregiver participation in a comprehensive assessment and establishment of the POC and; 3. The patient was not discharge from agency services and the assigned SN had not submitted any SN visit notes prior to and since the ROC OASIS on 01/04/24 (date of last known SN visit documented in the clinical record). Patient #4 A review of the clinical record showed no documentation of physician orders (episodic POCs) for POC certification periods of 02/18/24 to 04/17/24. Documentation showed no patient/caregiver participation in a comprehensive assessment and establishment of a POC, no physician notification of the conducted comprehensive (recertification) OASIS assessment and documented no physician orders. The last documented POC for the patient’s Home Health Agency episodic certification period was 12/20/23 to 02/17/24. On 02/21/24 from 2:00 to 2:30 p.m., Staff B stated: 1. Patient #4 did not have POCs (physician orders) for the certification period of 02/18/24 to 04/17/24; 2. Documentation showed no patient/caregiver participation in a comprehensive assessment and establishment of the POC and; 3. The patient was not discharge from agency services and the assigned SN had not submitted any SN visit notes since the recertification OASIS assessment on 12/18/23 (date of last known SN visit documented in the clinical record). Patient #5 A review of the clinical record showed no documentation of physician orders (episodic POCs) for POC certification periods of 11/16/23 to 01/14/24. Documentation showed no patient/caregiver participation in a comprehensive assessment and establishment of a POC, no physician notification of the conducted comprehensive (recertification) OASIS assessment and documented no physician orders. The last documented POC for the patient’s Home Health Agency episodic certification period was 01/15/24 to 03/14/24. On 02/21/24 from 2:00 to 2:30 p.m., Staff B stated: 1. Patient #5 did not have POCs (physician orders) for the certification periods of 11/16/23 to 01/14/24; 2. Documentation showed no patient/caregiver participation in a comprehensive assessment and establishment of the POC and; 3. The patient was not discharge from agency services and the assigned SN had not submitted any SN visit notes since 09/27/23 (date of last known SN visit documented in the clinical record). Patient #6 A review of the clinical record showed no documentation of physician orders (episodic POCs) for POC certification periods of 01/25/24 to 03/24/24. Documentation showed no patient/caregiver participation in a comprehensive assessment and establishment of a POC, no physician notification of the conducted comprehensive (recertification) OASIS assessment and documented no physician orders. The last documented POC for the patient’s Home Health Agency episodic certification period was 11/26/23 to 01/24/24. On 02/21/24 from 2:00 to 2:30 p.m., Staff B stated: 1. Patient #5 did not have POCs (physician orders) for the certification periods of 01/25/24 to 03/24/24; 2. Documentation showed no patient/caregiver participation in a comprehensive assessment and establishment of the POC and; 3. The patient was not discharge from agency services and the assigned SN had not submitted any SN visit notes since 09/14/23 (date of last known SN visit documented in the clinical record). Patient #9 A review of the clinical record showed no documentation of physician orders (episodic POCs) for POC certification periods of 08/24/23 to 09/07/23 (date of discharge from agency services). Documentation showed no patient/caregiver participation in a comprehensive assessment and establishment of a POC, no physician notification of the conducted comprehensive (recertification) OASIS assessment and documented no physician orders. The last documented POC for the patient’s Home Health Agency episodic certification period was 06/25/23 to 08/23/23. On 02/21/24 from 2:00 to 2:30 p.m., Staff B stated: 1. Patient #9 did not have POCs (physician orders) for the certification period of 08/24/23 to 09/07/23 (date of discharge from agency services); 2. Documentation showed no patient/caregiver participation in a comprehensive assessment and establishment of the POC and; 3. The assigned SN had not submitted any SN visit notes since 07/28/23 (date of last known SN visit documented in the clinical record).”

“State toll free HH telephone hotline CFR(s): 484.50(c)(9) Be advised of the state toll free home health telephone hot line, its contact information, its hours of operation, and that its purpose is to receive complaints or questions about local HHAs. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure OSDH complaint hotline contact information was included as a part of the agency’s grievance and complaint procedures for all patients. The failed practiced had the potential to hinder the abilities of patients, caregivers, family members and staff to report complaints, incidents or grievances with the agency. Findings: A review of administrative records showed no OSDH complaint hotline contact information was identified in the agency’s grievance statement presented to patients at the time of their start of care to the agency for all patients and employees. On 02/21/24 at 11:30 a.m., Staff B stated the agency’s grievance statement presented to patients at the time of their start of care to the agency did not include the OSDH complaint hotline contact information to report complaints, incidents or grievances with the agency.”

“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 a recertification (updated comprehensive [OASIS]) assessment was completed for six (Patients #1, 2, 3, 4, 5 and #9) of nine patients. The failed practice had the potential to impact the care and services required to meet the patient’s health care needs and outcomes for all patients. Findings: An agency policy, titled Comprehensive Assessment of Patients, stated each patient must receive an OASIS assessment the last 5 days of every 60 days beginning with the start of care date and at discharge. Patient #1 A review of the clinical record showed no documentation of recertification OASIS assessments conducted between 12/02/23 to 12/06/24 and 01/31/24 to 02/04/24 (days 55 through 60 of each 60 day certification period) and documented no physician orders. The last documented recertification OASIS assessment was for the patient’s Home Health Agency episodic certification period of 10/08/23 to 12/06/23. On 02/21/24 from 2:00 to 2:30 p.m., Staff B stated: 1. Patient #1 did not have a recertification OASIS assessments for the certification periods of 12/07/23 to 02/04/24 and 02/05/24 to 04/04/24; 2. The patient was not discharge from agency services and; 3. Date of last known SN visit documented in the clinical record was 09/14/23. Patient #2 A review of the clinical record showed no documentation of recertification OASIS assessments conducted between 01/01/24 to 01/05/24 (days 55 through 60 of each 60 day certification period) and documented no physician orders. The last documented recertification OASIS assessment was for the patient’s Home Health Agency episodic certification period was 11/07/23 to 01/05/24. On 02/21/24 from 2:00 to 2:30 p.m., Staff B stated: 1. Patient #2 did not have recertification OASIS assessment for the certification periods of 01/06/24 to 03/05/24; 2. The patient was not discharge from agency services and; 3. Date of last known SN visit documented in the clinical record was 10/06/23. Patient #3 A review of the clinical record showed no documentation of recertification OASIS assessments conducted between 11/04/23 to 11/08/24 (days 55 through 60 of the 60 day certification period) and documented no physician orders. The last documented POC for the patient’s Home Health Agency episodic certification period was 09/10/23 to 11/08/23. On 02/21/24 from 2:00 to 2:30 p.m., Staff B stated: 1. Patient #3 did not have recertification OASIS assessment for the certification periods of 11/09/23 to 01/07/24 and 01/08/24 to 03/07/24; 2. The patient was not discharge from agency services and; 3. Date of last known SN visit documented in the clinical record was 01/04/24. Patient #4 A review of the clinical record showed no documentation of recertification OASIS assessments conducted between 02/13/24 to 02/17/24 (days 55 through 60 of each 60 day certification period) and documented no physician orders. The last documented POC for the patient’s Home Health Agency episodic certification period was 12/20/23 to 02/17/24. On 02/21/24 from 2:00 to 2:30 p.m., Staff B stated: 1. Patient #4 did not have recertification OASIS assessments for the certification period of 02/18/24 to 04/17/24; 2. The patient was not discharge from agency services and; 3. Date of last known SN visit documented in the clinical record was 12/18/23. Patient #5 A review of the clinical record showed no documentation of recertification OASIS assessments conducted between 11/11/23 to 11/15/23 (days 55 through 60 of each 60 day certification period) and documented no physician orders. The last documented recertification OASIS assessments was for the patient’s Home Health Agency episodic certification period was 01/15/24 to 03/14/24. On 02/21/24 from 2:00 to 2:30 p.m., Staff B stated: 1. Patient #5 did not have recertification OASIS assessments for the certification periods of 11/16/23 to 01/14/24; 2. The patient was not discharge from agency services and; 3. Date of last known SN visit documented in the clinical record was 09/27/23. Patient #9 A review of the clinical record showed no documentation of recertification OASIS assessments conducted between 08/19/23 to 08/23/23 (days 55 through 60 of each 60 day certification period) and documented no physician orders. The last documented recertification OASIS assessments was for the patient’s Home Health Agency episodic certification period was 06/25/23 to 08/23/23. On 02/21/24 from 2:00 to 2:30 p.m., Staff B stated: 1. Patient #9 did not have recertification OASIS assessments for the certification period of 08/24/23 to 09/07/23 (date of discharge from agency services) and; 2. Date of last known SN visit documented in the clinical record was 07/28/23.”

“At discharge CFR(s): 484.55(d)(3) At discharge. This Element is not met as evidenced by: Based on record review and interview the agency failed to ensure a discharge oasis was completed by the agency for one (Patients #8) of nine patients. The failed practice had the potential to impact the coordination of follow up care needs and services effecting patient outcomes for all patients. Findings: An agency policy, titled Protocols for Home Health Care, stated Patients discharged from the agency must have a discharge OASIS assessment and a discharge summary must be sent to the physician within 5 days of the discharge date. An agency policy, titled Comprehensive Assessment of Patients, stated each patient must receive an OASIS assessment the last 5 days of every 60 days beginning with the start of care date and at discharge. Patient #8 A review of the clinical record showed documentation the patient was discharged on 10/10/23. Documentation showed no discharge OASIS assessment was completed. On 02/21/24 between 2:00 to 2:30 p.m., Staff B stated patients #8 had no discharge OASIS assessment completed at the time of discharge.”

“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 an individualized patient POC included weight reporting parameters for one (Patient #2) of nine patients. The failed practice had the potential to effect a patient’s response to health care interventions to achieve functional and physical health improvements for all patients. Findings: Patient #2 A review of the POC dated 11/07/23 to 01/05/24 showed orders for SN to conduct assessment and monitoring of patient weight every visit and notify the physician of change in patient weight with a SN visit frequency of one time a week for nine weeks. Documentation showed physician weight reporting parameters on the POC. Documentation showed no SN visits were conducted during the certification period and the last SN visit documented was 10/06/23. Documentation showed no patient/caregiver refusal of SN assessment and monitoring of the patient’s weight during the SN visits, no physician notifications and no change in orders. On 02/21/23 at 2:30 p.m., Staff B stated: 1. The SN who made the SN visits did not document the visits and there was no way to know if the patient was weighed or if the physician was notified of any change in weight and; The POC for patient #2 did not include a reporting weight parameter for physician notification.”

“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 reviews and interview, the agency failed to ensure resumption of care SN visit was ordered by the physician for one (Patient #3) of nine patients. The failed practice had the potential to impact the health, safety and well-being of patients by receiving care and services not ordered by their physician for all patients. Findings: An agency policy, titled,” Protocols for Home Health Care,” stated any patient admitted to the hospital must be resumed by an RN within 48 hours of the hospital discharge and a communication/order must be obtained from the primary care physician regarding the updated information from the resumption of care. Patient #3 A review of the clinical record showed no documentation of physician orders for a POC episode certification period of 11/19/23 to 01/07/24. Documentation showed no SN visits were conducted during the certification period until a ROC OASIS assessment was conducted on 01/04/24. Documentation showed no physician notification of a patient transfer to inpatient services on 12/26/23 prior to the ROC OASIS assessment conducted on 01/04/24 and showed no physician notification after the 01/04/24 SN visit and documented no orders. On 02/21/24 between 2:00 to 2:30 p.m., Staff B stated physician orders should have been obtained and documented prior to the SN ROC OASIS assessment conducted 01/04/24.”

“Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient’s condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure timely notification and physician opportunity to review and revise individualized POCs every 60 days for eight (Patients #1, 2, 3, 4, 5, 6, 8 and #9) of nine patients. The failed practice had the potential to effect the health and health care outcomes of all patients that required skilled care interventions to improve their health status. Findings: Patient #1 A review of the clinical record showed a SOC date of 02/20/21. Documentation showed subsequent episodic certification period of 10/08/23 to 12/06/23 were received and signed off by the physician on 11/21/23 (41 days from the beginning of the certification period). Documentation showed POC for episodic certification period 12/07/23 to 02/04/24 showed orders for SN one time a week for eight weeks and is unsigned (no documentation of attempts to send to the physician); episodic certification period 02/05/24 to 04/04/24 (16 days from the beginning of the certification period to the review date of 02/21/24) showed no documentation of a POC, no communication notes, no physician notification and no change in orders. Patient #2 A review of the clinical record showed a SOC date of 03/12/23. Documentation showed subsequent episodic certification period of 11/07/23 to 01/05/23 were sent to the physician on 01/08/24 and signed on 01/11/24 (65 days from the beginning of the certification period). POC for episodic certification period 01/06/24 to 03/05/24 (46 days from the beginning of the certification period to the review date of 02/21/24) showed no documentation of a POC, no communication notes, no physician notification and no change in orders. Patient #3 A review of the clinical record showed a SOC date of 11/24/20. Documentation showed subsequent episodic certification period of 07/12/23 to 09/09/23 were sent to the physician and signed on 01/18/24 (189 days from the beginning of the certification period). Subsequent episodic certification periods 09/10/23 to 11/08/23, 11/09/23 to 01/07/24 and 01/08/24 to 03/07/24 showed no documentation of a POCs, no communication notes, no physician notification and no change in orders. Patient #4 A review of the clinical record showed a SOC date of 10/21/23. Documentation showed subsequent episodic certification period of 10/21/23 to 12/19/23 was sent to the physician and signed on 02/07/24 (109 days from the beginning of the certification period) and 12/20/23 to 02/17/24 was sent to the physician and signed on 02/13/24 (55 days from the beginning of the certification period). Subsequent episodic certification period 02/18/24 to 04/17/24 showed no documentation of a POCs, no communication notes, no physician notification and no change in orders. Patient #5 A review of the clinical record showed a SOC date of 09/17/23. Documentation showed subsequent episodic certification period of 09/17/23 to 11/15/23 was sent to the physician and signed on 11/20/23 (64 days from the beginning of the certification period), subsequent episodic certification period 11/16/23 to 01/14/24 was sent to the physician and signed on 02/09/24 (84 days from the beginning of the certification period) and subsequent episodic certification period 01/15/24 to 03/14/24 (36 days from the beginning of the certification period to the review date of 02/21/24) showed no documentation of POCs, no communication notes, no physician notification and no change in orders. Patient #6 A review of the clinical record showed a SOC date of 08/03/22. Documentation showed subsequent episodic certification period of 07/29/23 to 09/26/23 were sent to the physician and signed on 12/18/23 (111 days from the beginning of the certification period), subsequent episodic certification periods 09/27/23 to 11/25/23, 11/26/23 to 01/24/24 and 01/25/24 to 03/24/24 showed no documentation of POCs, no communication notes, no physician notifications and no change in orders. Patient #8 A review of the clinical record showed a SOC date of 05/17/23. Documentation showed subsequent episodic certification period of 07/16/23 to 09/13/23 was sent to the physician and signed on 11/14/23 (122 days from the beginning of the certification period) and 09/14/23 to 11/12/23 was sent to the physician and signed on 11/14/24 (61 days from the beginning of the certification period). Documentation showed no communication notes, no physician notifications and no change in orders. Patient #9 A review of the clinical record showed a SOC date of 05/06/21. Documentation showed subsequent episodic certification period of 04/26/23 to 06/24/23 was sent to the physician and signed on 07/27/23 (93 days from the beginning of the certification period), subsequent episodic certification periods 06/25/23 to 08/23/23 was sent to the physician and signed on 07/28/23 (33 days from the beginning of the certification period) and 08/24/23 to 09/07/23 (date of discharge from agency services) showed no documentation of POC, no communication notes, no physician notifications and no change in orders. On 02/21/24 between 2:00 to 2:30 p.m., Staff B stated ensure timely notification and physician opportunity to review and revise individualized POCs every 60 days for patients #1, 2, 3, 4, 5, 6, 8 and #9.”

“Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure a designation of the clinical manager and/or supervising RN contact information for the agency was included in patient information packet for all patients and employees. The failed practice impeded the patient and/or caregivers ability to contact the agency with complaints, incidents or grievances related to their provision of care and services by the agency. Findings: A review of administrative records showed no identifying information for the clinical manager and/or supervising RN for the agency was included in the patient information packet provided to the patient at the time of their start of care with the agency. On 02/21/43 at 1:45 p.m., Staff B stated the agency had no clinical manager and/or supervising RN’s contact information for the agency included in the patient information packet provided to the patient at the time of their start of care with the agency.”

“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 SN conducted visit frequency as ordered on the POC for nine (Patients #1, 2, 3, 4, 5, 6, 7, 8 and #9) of nine patients. Findings: Patient #1 A review of the POC dated 12/07/23 to 02/04/24 showed orders for SN visit frequency one time a week for eight weeks. Documentation showed no SN visit were conducted (eight visit ordered, no visits conducted). Documentation showed no patient/caregiver refusal of care, physician notification or change in orders. Patient #2 A review of the POC dated 11/07/23 to 01/05/24 showed orders for SN visit frequency one time a week for nine weeks. Documentation showed no SN visit were conducted (nine visit ordered, no visits conducted; date of last SN visit conducted 10/06/23). Documentation showed no patient/caregiver refusal of care, physician notification or change in orders. Patient #3 A review of the POC dated 07/12/23 to 09/09/23 showed orders for SN visit frequency one time a week for nine weeks. Documentation showed from 07/12/23 to 09/09/23 one SN visit was conducted on 07/21/23 (one visit conducted, nine visit ordered). POC dated 09/10/23 to 11/08/23 showed orders for SN visit frequency one time a week for nine weeks. Documentation showed from 09/10/23 to 11/08/23 no SN visit was conducted (no visit conducted, nine visit ordered). Documentation showed no patient/caregiver refusal of care, physician notification or change in orders. Patient #4 A review of the POC dated 10/21/23 to 12/19/23 showed orders for SN visit frequency one time a week for nine weeks. Documentation showed from 10/21/23 to 12/19/23 no SN visit was conducted (no visit conducted, nine visit ordered). POC dated 12/20/23 to 02/17/24 showed orders for SN visit frequency one time a week for nine weeks. Documentation showed from 12/20/23 to 02/17/24 no SN visit was conducted (no visit conducted, nine visit ordered). Documentation showed no patient/caregiver refusal of care, physician notification or change in orders. Patient #5 A review of the POC dated 09/17/23 to 11/15/23 showed orders for SN visit frequency one time a week for nine weeks. Documentation showed SN visits were conducted on 09/21/23 and 09/27/23 (two visits conducted, nine visit ordered). POC dated 01/15/24 to 03/14/24 showed orders for SN visit frequency one time a week for nine weeks. Documentation showed from 01/15/23 to 02/20/24 (date of review) no SN visits conducted (no visit conducted, five visits ordered). Documentation showed no patient/caregiver refusal of care, physician notification or change in orders. Patient #6 A review of the POC dated 07/29/23 to 09/26/23 showed orders for SN visit frequency one time a week for nine weeks. Documentation showed SN visits were conducted on 08/17/23, 08/30/23, 09/06/23 and 09/14/23 (four visits conducted, nine visits ordered). POC dated 09/27/23 to 11/25/23 showed orders for SN visit frequency one time a week for nine weeks. Documentation showed from 09/27/23 to 11/25/23 no SN visits conducted (no visit conducted, nine visits ordered). Documentation showed no patient/caregiver refusal of care, physician notification or change in orders. POC dated 11/26/23 to 01/24/24 showed orders for SN visit frequency one time a week for nine weeks. Documentation showed from 11/26/23 to 01/24/24 no SN visits conducted (no visit conducted, nine visits ordered). Documentation showed no patient/caregiver refusal of care, physician notification or change in orders. Patient #7 A review of the POC dated 07/02/23 to 08/30/23 showed orders for SN visit frequency one time a week for nine weeks. Documentation showed during the week of 07/16/23 to 07/22/23 no SN visit conducted (one visit ordered, no visit conducted). Documentation showed no patient/caregiver refusal of care, physician notification or change in orders. Patient #8 A review of the POC dated 07/16/23 to 09/13/23 showed orders for SN visit frequency one time a week for nine weeks. Documentation showed during the weeks of 07/30/23 to 08/19/23 no SN visits conducted (three visits ordered, no visit conducted). Documentation showed no patient/caregiver refusal of care, physician notification or change in orders. Patient #9 A review of the POC dated 04/26/23 to 06/24/23 showed orders for SN visit frequency one time a week for nine weeks. Documentation showed SN visits were conducted on 05/02/23, 05/12/23, 05/19/23, 05/22/23, 05/29/23 and 06/09/23. During the weeks of 06/11/23 to 06/24/23 no SN visits conducted (two visits ordered, no visits conducted). POC dated 06/25/23 to 08/23/23 showed orders for SN visit frequency one time a week for nine weeks. Documentation showed SN visits were conducted on 06/30/23, 07/04/23, 07/11/23, 07/21/23 and on 07/28/23. During weeks of 07/30/23 to 08/23/23 no SN visits conducted (four visits ordered, no visits conducted). Documentation showed no patient/caregiver refusal of care, physician notification or change in orders. On 02/21/24 from 2:00 to 2:30 p.m., Staff B stated SN should have conducted SN visits as ordered in the POCs for patients #1, 3, 4, 5, 6, 8 and #9.”

“Ensures qualified pre-designated person CFR(s): 484.105(b)(2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure governing body appointment of an administrator for the agency effecting all patients and employees. This failed practice had the potential to affect the care services provided by the agency impacting subsequent care outcomes of the patients. Findings: A review of administrative records of governing body over-site of the agency showed no documentation appointment of an alternate administrator or administrator designee for the agency. On 02/21/24 at 1:45 p.m., Staff B stated: 1. She was the administrator and director of nurses (clinical manager) for the agency and; 2. Governing body administrative records showed no appointment of an alternate designee for the administrator of the agency.”

“Assure implementation of plan of care CFR(s): 484.105(c)(5) Assuring the development, implementation, and updates of the individualized plan of care. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure development, implementation and update of individualized patient POCs by the designated administrator/clinical manager (Staff B) for the agency for seven (Patients #1, 2, 3, 4, 5, 6 and #9) of nine patients and all employees. The failed practice affected the agency’s ability to effectively provide appropriate care and services to its patients. Findings: On 02/20/24 at 9:15 a.m., an announced on-site visit to the agency was conducted for survey purposes. Lists of active patients and discharged patient in the last six months were requested. A review of administrative records showed documentation that six (Patients #1, 2, 3, 4, 5 and #6) of six active patients and three (Patients #7, 8 and #9) of seven patients discharged in the last six months were selected for the survey sample. Clinical record documentation showed that seven (Patients 1, 2, 3, 4, 5, 6 and #9) of nine patients had no individualized POCs for one or more 60 day certification periods for each Home Health episodic periods. See Tag G572. Administrative records which showed operational oversight of the agency by the administrator/clinical manager (Staff B) in 2022 and 2023 and agency case conference and/or discharge planning coordination reports for all nine (Patients 1, 2, 3, 4, 5, 6, 7, 8 and #9) survey sample patients were requested. No documentation was provided. On 02/21/24 at 1:45 p.m., Staff B stated: 1. There was no documentation which showed operational oversight of the agency by the administrator/clinical manager (Staff B) for 2022 and 2023 and; 2. The agency had no case conference and/or discharge planning coordination reports that ensured documentation of the development, implementation and update of individualized patient POCs for all patients by the designated administrator/clinical manager (Staff B) for the agency.”