Every finding on record at Bethlehem Home Health Care, Inc

An extended survey for Medicare certification for Bethlehem Home Health Care, Inc. was completed on 04/14/2022. The agency had two (2) current patients. Eleven (11) condition-level deficiencies were identified during the survey. Condition level deficiencies were identified at: §484.50 Condition of Participation: Patient Rights; §484.55 Condition of Participation: Comprehensive Assessment of Patients; §484.58 Condition of Participation: Discharge planning; §484.60 Condition of Participation: Care Planning, Coordination and Quality of Care; §484.65 Condition of Participation: Quality Assessment and Performance Improvement; §484.70 Condition of Participation: Infection Control; §484.75 Condition of Participation: Skilled Professional Services; §484.100 Condition of Participation: Compliance with Federal, State, and Local Law; §484.105 Condition of Participation: Organization and Administration of Services; §484.110 Condition of Participation: Clinical Records; and The Emergency Preparedness regulations were reviewed as part of the Medicare certification survey completed on 04/14/2022. One condition level deficiency was identified at §484.102 Condition of Participation: Emergency Preparedness for Home Health Agencies. A home health agency found out of compliance with any Condition of Participation evaluated as part of a standard survey may not train or competency evaluate their home health aides for a period of two (2) years following the date of this survey. A deficiency has been cited at §484.80(f) (3) -see Tag G788.

Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms "facility" or "facilities" in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This CONDITION is not met as evidenced by: Based on review of the Bethlehem Home Health, Inc. Emergency Preparedness (EP) Plan, and interview, the home health agency (HHA) failed to establish an emergency preparedness program to meet the federal, state, and local emergency preparedness program requirements. The emergency preparedness program must include, but not limited to, the following elements: - The HHA must develop and maintain an emergency preparedness plan that must be reviewed and updated at least every two (2) years (E0004); - Develop and implement emergency preparedness policies and procedures, based on the emergency plan, risk assessment and communication plan (E0013); - Develop emergency preparedness policies and procedures that include a plan for the agency patients during a natural or man-made disaster, and include the individual plan for each patient in the comprehensive patient assessment (E0017); - Develop emergency preparedness policies and procedures that address the procedures to follow up with on-duty staff and patients to determine services that are needed in the event there is an interruption in services during or due to an emergency; and that the agency must inform State and local officials of any on-duty staff or patients they are unable to contact (E0021); - Develop emergency preparedness policies and procedures that address a system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures/maintains the availability of records (E0023); - The use of volunteers in emergency or other emergency staffing strategies, including the process and role for integrations of State and Federally designated health care professionals to address surge needs during an emergency (E0024); - Develop and maintain a communication plan that complies with federal, state, and local laws that is reviewed and updated at least annually (E0029); - Primary and alternate means for communicating with the HHA's staff, Federal, State, tribal, regional, and local emergency management agencies (E0032); - A means of providing information about the HHA's needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee (E0034); - Develop and maintain an emergency preparedness training and testing program that is based on the emergency plan, risk assessment, policies and procedures and the communication plan that is reviewed and updated at least annually (E0036); - Develop a training program that includes initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers; provide emergency preparedness training at least annually; maintain documentation of all of all emergency preparedness training; and demonstrate staff knowledge of emergency procedures (E0037); and - Conduct exercises (full-scale exercises/tabletop exercises) to test the emergency plan and analyze, maintain documentation of the exercise and revise as needed at least annually (E0039). The cumulative effect of this deficient practice has the potential to affect the quality of care and safety of all agency patients.

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on review of the agency's Emergency Preparedness (EP) Plan manual and interview, the agency failed to review and update their Emergency Preparedness Plan every two years. This deficient practice has the potential to adversely affect the care and safety of all patients served by the agency during an emergency. Findings included: Review of the agency's EP Plan showed the plan had not been updated since 2019. During an interview on 04/12/2022 at 9:58 AM, the interim clinical manager stated that he/she did not know the last time the Emergency Preparedness manual has been updated. During an interview on 04/13/2022 at 2:41 PM, the administrator stated that he/she monitors the emergency preparedness program by communicating with the nurse. The nurse is responsible for the EP program. The EP plan and the program will be fixed when a nurse is hired.

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), §485.625(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 requested document review, and interview, the agency failed to develop emergency preparedness policies and procedures. This deficient practice has the potential to affect the health, safety, and well-being of all patients and staff of the agency. Findings included: The agency’s administrator provided the Missouri Department of Health and Senior Services, Ready in 3: Three Steps to Prepare for an Emergency on 04/12/2022 at 2:30 PM, as the agency’s emergency preparedness policy and procedure. During an interview on 04/12/2022 at 2:30 PM, the administrator stated that the Missouri Department of Health and Senior Services, Ready in 3: Three Steps to Prepare for an Emergency, was the agency’s emergency preparedness plan and the agency’s EP policy and procedure. There were no other policy and procedures provided by the administrator. During an interview on 04/13/2022 at 2:41 PM, the administrator stated that he/she monitors the emergency preparedness program by communicating with the nurse and the nurse was responsible for the EP program. The EP plan and the program will be fixed when a nurse is hired.

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure each patient had an individualized emergency plan documented as part of the patient's comprehensive assessment in four (Records/Patients #2, #3, #4, and #5) of five cases reviewed. This deficient practice has the potential to affect all patients receiving home health services from the agency. Findings included: Review of the clinical records showed that the comprehensive assessments completed for record/patient #2 on 04/01/2022, record/patient #3 on 03/22/2019, record/patient #4 on 10/21/2021, and record/patient #5 on 06/22/2021 failed to include an individualized emergency plan. During an interview on 04/12/2022 at 8:35 AM, the administrator stated that the clinical manager resigned and a nurse who worked for the agency was taking over. During an interview on 04/13/2022 at 11:55 AM, the interim clinical manager stated that he/she thought there were policies and procedures on patient emergency plans but was unsure where they were. He/she could not recall where to find the patients individualized emergency plan. During an interview on 04/13/2022 at 2:41 PM, the administrator stated that he/she monitors the EP program by communicating with the nurse. The nurse was responsible for the EP program and will will be fixed when a nurse is hired.

HHA- Procedures for Follow up Staff/Pts. CFR(s): 484.102(b)(3) §484.102(b)(3) Condition of Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (3) The procedures to follow up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency. The HHA must inform State and local officials of any on-duty staff or patients that they are unable to contact. This STANDARD is not met as evidenced by: Based on review of the agency’s Emergency Preparedness (EP) manual and interview, the agency failed to update emergency preparedness procedure regarding how the agency will follow up with on-duty staff and patients to determine services that are needed and the process for informing State and local officials of any on-duty staff or patients that the agency is unable to contact. This deficient practice has the potential to affect the health, safety, and well-being of all patients and staff of the agency. Findings included: Review of the EP manual showed no current list of the agency’s employees and patients. During an interview on 04/13/2022 at 2:41 PM, the administrator stated that he/she monitored the emergency preparedness program by communicating with the nurse, and the nurse was responsible for the EP program and would be fixed when a nurse was hired.

Policies/Procedures for Medical Documentation CFR(s): 484.102(b)(4) §403.748(b)(5), §416.54(b)(4), §418.113(b)(3), §441.184(b)(5), §460.84(b)(6), §482.15(b)(5), §483.73(b)(5), §483.475(b)(5), §484.102(b)(4), §485.68(b)(3), §485.625(b)(5), §485.727(b)(3), §485.920(b)(4), §486.360(b)(2), §491.12(b)(3), §494.62(b)(4). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(5) or (3),(4),(6)] A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records. *[For RNHCIs at §403.748(b):] Policies and procedures. (5) A system of care documentation that does the following: (i) Preserves patient information. (ii) Protects confidentiality of patient information. (iii) Secures and maintains the availability of records. *[For OPOs at §486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. This STANDARD is not met as evidenced by: Based on review of the agency's Emergency Preparedness (EP) Plan manual and interview, the agency failed to develop an emergency preparedness system of documentation that preserved patient information, protected confidentiality, and secured and maintained the availability of records. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency's EP manual did not have a policy for emergency preparedness system of documentation that preserved patient information, protected confidentiality, and secured and maintained the availability of records. During an interview on 04/13/2022 at 2:41 PM, the administrator stated that he/she monitored the emergency preparedness program by communicating with the nurse, and the nurse was responsible for the EP program and would be fixed when a nurse was hired.

Policies/Procedures-Volunteers and Staffing CFR(s): 484.102(b)(5) §403.748(b)(6), §416.54(b)(5), §418.113(b)(4), §441.184(b)(6), §460.84(b)(7), §482.15(b)(6), §483.73(b)(6), §483.475(b)(6), §484.102(b)(5), §485.68(b)(4), §485.625(b)(6), §485.727(b)(4), §485.920(b)(5), §491.12(b)(4), §494.62(b)(5). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] (6) [or (4), (5), or (7) as noted above] The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. *[For RNHCIs at §403.748(b):] Policies and procedures. (6) The use of volunteers in an emergency and other emergency staffing strategies to address surge needs during an emergency. *[For Hospice at §418.113(b):] Policies and procedures. (4) The use of hospice employees in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. This STANDARD is not met as evidenced by: Based on observation and interview, the agency failed to ensure a policy for emergency staffing strategies was developed for the agency's Emergency Preparedness (EP) plan. This deficient practice has the potential to adversely affect the care and safety of all patients served by the agency during an emergency. Findings included: Review of the agency's EP manual did not include a policy for emergency staffing strategies or the use of volunteers during an emergency; including the process and role for integration of state and federally designated health care professionals to assist with needs during an emergency. The agency’s administrator provided the Missouri Department of Health and Senior Services, Ready in 3: Three Steps to Prepare for an Emergency on 04/12/2022 at 2:30 PM, as the agency’s emergency preparedness policy and procedure. (This did not include a policy for emergency staffing strategies or the use of volunteers during an emergency.) During an interview on 04/12/2022 at 2:30 PM, the administrator stated that the Missouri Department of Health and Senior Services, Ready in 3: Three Steps to Prepare for an Emergency was the agency’s emergency preparedness was the agency’s EP policy and procedure. During an interview on 04/13/2022 at 2:41 PM, the administrator stated that he/she monitored the emergency preparedness program by communicating with the nurse, and the nurse was responsible for the EP program and would be fixed when a nurse was hired.

Development of Communication Plan CFR(s): 484.102(c) §403.748(c), §416.54(c), §418.113(c), §441.184(c), §460.84(c), §482.15(c), §483.73(c), §483.475(c), §484.102(c), §485.68(c), §485.625(c), §485.727(c), §485.920(c), §486.360(c), §491.12(c), §494.62(c). (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]. This STANDARD is not met as evidenced by: Based on review of the agency's Emergency Preparedness (EP) manual and interview, the agency failed to develop a comprehensive communication plan that included names and contact information of staff, physicians, and other service provider to be accessed during an emergency. This deficient practice has the potential to adversely affect the care and safety of all patients served by the agency during an emergency Findings included: Review of the agency's EP manual did not show a comprehensive communication plan that included names and contact information of current staff, physicians and other service providers to be accessed during an emergency. During an interview on 04/13/2022 at 2:41 PM, the administrator stated he/she monitors the Emergency Preparedness program by communicating with the nurse. The nurse is responsible for the EP program. The EP plan and the program will be fixed when a nurse is hired. There was no additional information provided.

Primary/Alternate Means for Communication CFR(s): 484.102(c)(3) §403.748(c)(3), §416.54(c)(3), §418.113(c)(3), §441.184(c)(3), §460.84(c)(3), §482.15(c)(3), §483.73(c)(3), §483.475(c)(3), §484.102(c)(3), §485.68(c)(3), §485.625(c)(3), §485.727(c)(3), §485.920(c)(3), §486.360(c)(3), §491.12(c)(3), §494.62(c)(3). [(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: (3) Primary and alternate means for communicating with the following: (i) [Facility] staff. (ii) Federal, State, tribal, regional, and local emergency management agencies. *[For ICF/IIDs at §483.475(c):] (3) Primary and alternate means for communicating with the ICF/IID's staff, Federal, State, tribal, regional, and local emergency management agencies. This STANDARD is not met as evidenced by: Based on review of the agency’s Emergency Preparedness (EP) manual and interview, the agency failed to develop an emergency preparedness communication plan that includes primary and alternate means of communicating with agency staff, and Federal, State, tribal, regional, and local emergency management agencies. This deficient practice has the potential to adversely affect the care and safety of all patients served by the agency during an emergency. Findings included: Review of the EP manual did not show a communication plan that included primary and alternate means of communicating with agency staff, and Federal, State, tribal, regional, and local emergency management agencies. During an interview on 04/13/2022 at 2:41 PM, the administrator stated he/she monitors the emergency preparedness program by communicating with the nurse and the nurse is responsible for the EP program. The EP plan and the program will be fixed when a nurse is hired. There was no further information provided.

Information on Occupancy/Needs CFR(s): 484.102(c)(6) §403.748(c)(7), §416.54(c)(7), §418.113(c)(7) §441.184(c)(7), §482.15(c)(7), §460.84(c)(7), §483.73(c)(7), §483.475(c)(7), §484.102(c)(6), §485.68(c)(5), §485.68(c)(5), §485.727(c)(5), §485.625(c)(7), §485.920(c)(7), §491.12(c)(5), §494.62(c)(7). [(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: (7) [(5) or (6)] A means of providing information about the [facility's] occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For ASCs at 416.54(c)]: (7) A means of providing information about the ASC's needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For Inpatient Hospice at §418.113(c):] (7) A means of providing information about the hospice's inpatient occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. This STANDARD is not met as evidenced by: Based on review of the agency’s Emergency Preparedness (EP) manual and interview, the agency failed to develop an emergency preparedness communication plan that includes a means of providing information about the agency's needs; and its ability to provide assistance to the authority having jurisdiction, the Incident Command Center/designee. This deficient practice has the potential to adversely affect the care and safety of all patients served by the agency during an emergency. Findings included: Review of the EP manual failed to show a communication plan that includes a means of providing information about the agency's needs; and its ability to provide assistance to the authority having jurisdiction, the Incident Command Center/designee. During an interview on 04/13/2022 at 2:41 PM, the administrator stated he/she monitors the emergency preparedness program by communicating with the nurse and the nurse is responsible for the EP program. The EP plan and the program will be fixed when a nurse is hired. There was no further information provided.

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), §485.625(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, 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 review of the agency’s Emergency Preparedness (EP) manual and interview, the agency failed to maintain a comprehensive emergency preparedness plan that provides a training and testing program that is reviewed and updated at least every two years. This deficient practice has the potential to affect all patients are by the agency. Findings Included: Review of the agency's EP Plan showed no updated comprehensive emergency preparedness plan. During an interview on 04/12/2022 at 9:58 AM, the interim clinical manager stated that he/she did not know the last time the EP training and testing was done. During an interview on 04/13/2022 at 2:41 PM, the administrator stated he/she monitors the EP program by communicating with the nurse. The nurse is responsible for the EP program. The EP plan and program will be fixed when a nurse is hired. There was no additional information provided.

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), §485.625(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, "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, the agency failed to ensure staff were provided annual Emergency Preparedness (EP) training in five (Employee #1, #2, #3, #4 and #5) of five employee files reviewed. This deficient practice has the potential to adversely affect the care and safety of all patients served by the agency during an emergency. Findings included: EMPLOYEE #1 (E1) Date of hire: 02/16/2012; Position: Interim clinical manager; and no evidence of EP training. EMPLOYEE #2 (E2) Date of hire: No information; Position: Occupational Therapist; and no evidence of EP training. EMPLOYEE #3 (E3) Date of hire: 01/26/2011; Position: Physical therapist; and no evidence of EP training. EMPLOYEE #4 (E4) Date of hire: 11/18/2019; Position: Registered nurse; and no evidence of EP training. EMPLOYEE #5 (E5) Date of hire: 05/14/2018; Position: Administrator; and no evidence of EP training. During an interview on 04/13/2022 at 2:41 PM, the administrator stated that he/she had reviewed all of the employee files and there was no additional documentation to provide.

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on review of the agency's Emergency Preparedness (EP) manual and interview, the agency failed to conduct exercises to test the emergency plan annually and analyze the agency's response to and maintain documentation of all drills, table top exercises, and emergency events, and revise the agency's emergency plan as needed. This deficient practice has the potential to adversely affect the care and safety of all patients served by the agency during an emergency. Findings included: Review of the agency's EP binder failed to include documentation of: - Emergency drills or table top exercises in 2020, 2021 or 2022; and - Community based exercises documented in 2020, 2021 or 2022. During an interview on 04/13/2022 at 2:41 PM, the administrator stated that he/she monitored the emergency preparedness program by communicating with the nurse, the nurse was responsible for the EP program and would be fixed when a nurse was hired.

Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure that each completed OASIS (Outcome and Assessment Information Set-a required set of assessment data submitted to Medicare and Medicaid Services) assessment was encoded and electronically transmitted within the required 30 days of completion of each patient's comprehensive assessment, in three (Records/Patients #1, #3, and #5) of five records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: RECORD/PATIENT #1: Review of the clinical record showed: - RN (registered nurse) SOC (start of care) visit on 09/26/2019 at 10:25 AM; and - SOC documentation completed with electronic signature on 12/12/2019 at 12:28 PM (2 months and 16 days later). RECORD/PATIENT #3: Review of the clinical record showed: - RN SOC visit on 03/22/2019 at 10:15 AM; - SOC documentation completed with electronic signature on 06/26/2019 at 4:08 PM (3 months and 4 days later); - Recertification visit on 07/08/2021 at 4:05 PM; - Recertification documentation completed with electronic signature on 09/15/2021 at 9:45 AM (2 months and 7 days later); - Discharge visit on 11/05/2021 at 4:00 PM; and - Discharge oasis documentation completed with electronic signature on 03/15/2022 at 3:56 PM (4 months and 10 days later). RECORD/PATIENT #5: Review of the clinical record showed: - Discharge visit on 08/13/2021 at 4:00 PM; and - Discharge oasis documentation completed with electronic signature on 03/15/2022 at 4:11 PM (7 months and 2 days). During an interview on 04/12/2022 at 1:05 PM, the administrator stated, documentation has to be completed within 30 days, for all documentation. During an interview on 04/13/2022 at 11:25 AM, the interim clinical manager (CM) stated: - The electronic signature date is when documentation is completed and locked; - The CM is the only one that can complete and lock the electronic records; - The CM electronically signs all electronic records for visits even if the CM is not the nurse that did the visit; - The name of the SN (skilled nurse) that completed the visits does not show up on the electronic record; and - There is no way to know who the SN was that actually completed the visit.

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 policy review, current patient rights information, and interview, the agency failed to develop and provide the patient and/or representative with a written notice of patient rights that included all required information. The agency failed to provide in writing, in advance of furnishing care, the following information: - The contact information for the home health agency's current administrator, including the name of the administrator (G414); - The patient has the right to participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to: ** The completion of all assessments; and ** The care to be furnished, based on the comprehensive assessment (G434); - Receive all services as outlined in the plan of care (G436); - The patient has the right to be advised orally and in writing of the extent to which payment for home health agency services may be expected from Medicare, Medicaid, or any other Federally funded or Federal aid program known to the home health agency, any changes in the financial information provided in accordance with paragraph (c)(7) of this section when they occur, the agency must advise the patient and representative of these changes as soon as possible, in advance of the next home health visit, the agency must comply with the patient notice requirements at 42 CFR 411.408(d)(2) and 42 CFR 411.408(f) (G440); - The patient has the right to receive proper written notice, in advance of a specific service being furnished if the agency believes that the service may be non-covered care; or in advance of the home health agency reducing or terminating on-going care (G442); - Be advised of the state toll free home health telephone hotline, its contact information, its hours of operation, and that its purpose is to receive complaints or questions about local home health agencies (G444); - Be advised of the names, addresses, and telephone numbers of the federally-funded and state-funded entities that serve the area where the patient resides that include: Agency on Aging, Center for Independent Living, Protection and Advocacy Agency, Aging and Disability Resource Center, and the Quality Improvement Organization of Livanta LLC (G446); - The patient and representative (if any) have a right to be informed of the agency's policies for transfer and discharge as follows: ** The transfer or discharge is necessary for the patient's welfare because the HHA and the physician who is responsible for the home health plan of care that the HHA can no longer meet the patient's needs, based on the patient's acuity. The HHA must arrange a safe and appropriate transfer to other care entities when the needs of the patient exceed the HHA's capabilities (G454); ** The patient or payer will no longer pay for the services (G456); ** The physician and agency agree that the outcomes and goals have been achieved and the patient no longer needs the agency services (G458); ** The patient refuses services or elects to be transferred or discharged (G460); ** The agency determines that the patients or other persons in the home, behavior is disruptive, abusive or uncooperative to extent that the delivery of care to the patient or the ability of the agency to operate effectively is impaired (G462); ** The agency must advise the patient or representative, physicians, and healthcare professionals who will be responsible for providing care after discharge, that a discharge for cause is being considered (G464); ** The agency must make efforts to resolve the problem(s) presented by the patient’s behavior, the behavior of other person’s in the patient’s home, or situation (G466); ** The agency must provide the patient and representative (if any), with contact information for other agencies or providers who may be able to provide care after discharge (G468); ** The agency must document the problem and efforts made to resolve the problem (G470); ** The patient dies (G472); and ** The agency ceases to operate (G474). The cumulative effect of these deficient practices resulted in the agency's inability to ensure that all patients and/or representatives were informed of their rights and responsibilities. .

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 review of the agency's current patient rights information and interview, the agency failed to update the written notice of patient rights to include the rights of the patient and representative (if any) regarding contact information for the home health agency administrator to receive complaints. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency's admission packet failed to show the current administrator name for which to receive patient complaints. On 04/11/2022 at 12:10 PM, the intake specialist stated that the patient rights information in the admission packets are the current patient rights for the agency. On 04/13/2022 at 2:40 PM, the administrator acknowledged issues with patient rights. No further documentation provided.

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 review of the agency's current patient rights information and interview, the agency failed to update the written notice of patient rights to include the patient has the right to participate in, be informed about, and consent or refuse care, with respect to completion of all assessments, care to be furnished based on the comprehensive assessment, and expected outcomes. The deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: Review of the agency's undated current patient rights information sheet titled, "Patient’s Bill of Rights," failed to include: - Completion of all assessments; and - The care to be furnished, based on the comprehensive assessment. On 04/11/2022 at 12:10 PM, the intake specialist stated that the patient rights information in the admission packets were the current patient rights for the agency. On 04/13/2022 at 2:40 PM, the administrator acknowledged issues with patient rights. No further documentation provided.

Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This ELEMENT is not met as evidenced by: Based on review of the agency's current patient rights information sheet and interview, the agency failed to include the patient has the right to receive all services outlined in the plan of care. The deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: Review of the agency's undated current patient rights information sheet titled, "Patient’s Bill of Rights," showed, in part: - Patients have the right to participate in planning their care and treatment and the right to appropriate instruction and education regarding the plans and any changes, including discharges and transfer to another agency or level of care, and any decisions to withhold resuscitation or forego lifesaving care; - Patients have the right to reasonable continuity of care and respect of property and frequency of visits proposed; and - The patient bill of rights information sheet failed to include the right to receive all services outlined in the plan of care. On 04/11/2022 at 12:10 PM, the intake specialist stated that the patient rights information in the admission packets were the current patient rights for the agency. On 04/13/2022 at 2:40 PM, the administrator acknowledged issues with patient rights. No further documentation provided.

Payment from federally funded programs CFR(s): 484.50(c)(7)(i, ii, iii, iv) Be advised, orally and in writing, of- (i) The extent to which payment for HHA services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (ii) The charges for services that may not be covered by Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (iii) The charges the individual may have to pay before care is initiated; and (iv) Any changes in the information provided in accordance with paragraph (c)(7) of this section when they occur. The HHA must advise the patient and representative (if any), of these changes as soon as possible, in advance of the next home health visit. The HHA must comply with the patient notice requirements at 42 CFR 411.408(d)(2) and 42 CFR 411.408(f). This ELEMENT is not met as evidenced by: Based on review of the agency’s conditions and consent for admission form, current patient rights information sheet, and interview, the agency failed to ensure the patient was advised orally and in writing of the extent to which payment for services may be expected from Medicare, Medicaid, or any other federally-funded aid program, the charges of services that may not be covered. This deficient practice has the potential to adversely affect the patient's ability to pay for services for all agency's patients. Findings included: Review of the agency's consent for admission form, titled, "Bethlehem Home Health Care Agency Conditions and Consent for Admission," showed, in part: - Authorization for payment: “I hereby authorize the agency to submit a claim for payment for any services I received by the agency and am in directing the carrier providing my health benefit coverage to pay the agency directly for these services, but not to exceed the charges for services rendered; - “I acknowledge that it is my responsibility to contact the agency immediately if my health benefit coverage changes; - The form failed to include the extent to which payment for services may be expected from Medicare, Medicaid, or any other federally-funded aid program; and - The form failed to include the charges of services that may not be covered. Review of the agency's undated current patient rights information sheet titled, "Patient’s Bill of Rights," showed, in part: - Patients have the right to be fully informed of agency policies and changes for services, including, eligibility for their third-party reimbursement, prior to receiving care whether federally funded or aided; - In visiting, through execution of an advanced beneficiary notice, when appropriate, of any changes in the charge, extent of Medicare/Medicaid or federal program coverage, or patient liability as soon as possible but no later than 30 days from the date the agency becomes aware of change; and - Provide patient with notice of Privacy Practices and leave a copy of the statement of rights and the financial agreement with the patient. On 04/11/2022 at 12:10 PM, the intake specialist stated that the patient rights information in the admission packets are the current patient rights for the agency.

Written notice for non-covered care CFR(s): 484.50(c)(8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. This ELEMENT is not met as evidenced by: Based on review of the agency’s conditions and consent for admission form, current patient rights information, and interview, the agency failed to include the patient has the right to receive proper written notice, in advance of a specific service being furnished, if the agency believes that the service may be non-covered care; or in advance of the agency reducing or terminating on-going care. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: Review of the agency's consent for admission form, titled, "Bethlehem Home Health Care Agency Conditions and Consent for Admission," showed, in part: - Authorization for payment: “I hereby authorize the agency to submit a claim for payment for any services I received by the agency and am in directing the carrier providing my health benefit coverage to pay the agency directly for these services, but not to exceed the charges for services rendered; - “I acknowledge that it is my responsibility to contact the agency immediately if my health benefit coverage changes; and - The form failed to include the right to receive proper written notice, in advance of a specific service being furnished, if the agency believes that the service may be non-covered care, or in advance of the agency reducing or terminating on-going care. Review of the agency's undated current patient rights information sheet titled, "Patient’s Bill of Rights," showed, in part: - Patients have the right to be fully informed of agency policies and changes for services, including, eligibility for their third-party reimbursement, prior to receiving care whether federally funded or aided; - In visiting, through execution of an advanced beneficiary notice, when appropriate, of any changes in the charge, extent of Medicare/Medicaid or federal program coverage, or patient liability as soon as possible but no later than 30 days from the date the agency becomes aware of change; and - Provide patient with notice of Privacy Practices and leave a copy of the statement of rights and the financial agreement with the patient. On 04/11/2022 at 12:10 PM, the intake specialist stated that the patient rights information in the admission packets are the current patient rights for the agency.

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 review of the agency’s policy, current patient rights information sheet, and interview, the agency failed to ensure staff provided the written notice of the updated state toll free home health telephone hotline hours of operation (7:00 AM to 8:00 PM, seven days a week) in the admission folder. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities for all patients/representatives served by the agency. Findings included: Review of the agency's undated policy titled, "Home Health Hotline," showed, in part: - Staff are provided information about the home health hotline during orientation and at least annually during in service training programs; - The purpose of the home health hotline is to receive complaints or questions about local HHAs (home health agencies); - The patient may also use the hotline to report complaints concerning the implementation of the advance directive requirements; and - Hotline hours available 7am-Midnight (7:00 AM to 12:00 AM), 7 days per week . Review of the agency's undated current patient rights information sheet titled, "Your Rights & Responsibilities," showed, in part: - The patient has the right to choose care providers and the right to communicate with those providers; - Be informed orally, and in writing of his/her rights and access to the home health hotline number, hours, and purpose; and - The current patient rights information sheet failed to show the hotline number and hours. On 04/11/2022 at 12:10 PM, the intake specialist stated that the patient rights information in the admission packets were the current patient rights for the agency. On 04/13/2022 at 2:40 PM, the administrator acknowledged issues with patient rights. No further documentation provided.

Contact info Federal/State-funded entities CFR(s): 484.50(c)(10)(i,ii,iii,iv,v) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: (i) Agency on Aging (ii) Center for Independent Living (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. This ELEMENT is not met as evidenced by: Based on review of the agency's current patient rights information and interview, the agency failed to update the written notice of patient rights to include the name, address and phone number of the current Quality Improvement Organization (QIO) that serves the area where the patient resides.This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the current patient rights information failed to include: - The current QIO organization; and - The agency failed to list the current complete QIO information for: * Livanta LLC BFCC-QIO Program 10820 Guilford Road, Suite 202 Annapolis Junction, MD 20701-1105 Phone No 1-888-755-5580 TTY: 1-888-985-9295 On 04/11/2022 at 12:10 PM, the intake specialist stated that the patient rights information in the admission packets are the current patient rights for the agency. On 04/13/2022 at 2:40 PM, the administrator acknowledged issues with patient rights. No further documentation provided.

HHA can no longer meet the patient's needs CFR(s): 484.50(d)(1) The transfer or discharge is necessary for the patient's welfare because the HHA and the physician or allowed practitioner, who is responsible for the home health plan of care agree that the HHA can no longer meet the patient's needs, based on the patient's acuity. The HHA must arrange a safe and appropriate transfer to other care entities when the needs of the patient exceed the HHA's capabilities; This ELEMENT is not met as evidenced by: Based on review of the agency's current patient rights information and interview, the agency failed to provide written notice of patient rights to include that the patient and representative (if any) have a right to be informed of the agency's policies for transfer and discharge when the agency can no longer meet the patient's needs. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: The intake specialist provided an admission packet for review on 04/11/2022. The agency notice of patient rights failed to include that the patient and representative (if any) have a right to be informed of the agency's policies for transfer and discharge when the agency can no longer meet the patient's needs and other information given to a patient during the initial visit contained no written information regarding the agency's policies for transfer and discharge. On 04/11/2022 at 12:10 PM, the intake specialist stated that the agency’s discharge and transfer policy will be added to the admission packets. On 04/13/2022 at 2:40 PM, the administrator acknowledged issues with patient rights. No further documentation provided.

Patient/payer will no longer pay for services CFR(s): 484.50(d)(2) The patient or payer will no longer pay for the services provided by the HHA; This ELEMENT is not met as evidenced by: Based on review of the agency current patient rights information and interview, the agency failed to provide written notice of patient rights to include that the patient and representative (if any) have a right to be informed of the agency's policies for transfer and discharge when the patient or payer can no longer pay for the services. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: The intake specialist provided an admission packet for review on 04/11/2022. The agency notice of patient rights and other information given to a patient during the initial visit contained no written information regarding that the patient and representative (if any) have a right to be informed of the agency's policies for transfer and discharge when the patient or payer can no longer pay for the services. On 04/11/2022 at 12:10 PM, the intake specialist stated that the agency’s discharge and transfer policy will be added to the admission packets. On 04/13/2022 at 2:40 PM, the administrator acknowledged issues with patient rights. No further documentation provided.

Outcomes/goals have been achieved CFR(s): 484.50(d)(3) The transfer or discharge is appropriate because the physician or allowed practitioner, who is responsible for the home health plan of care and the HHA agree that the measurable outcomes and goals set forth in the plan of care in accordance with §484.60(a)(2)(xiv) have been achieved, and the HHA and the physician or allowed practitioner, who is responsible for the home health plan of care agree that the patient no longer needs the HHA's services; This ELEMENT is not met as evidenced by: Based on review of the agency's current patient rights information and interview, the agency failed to provide written notice of patient rights to include the patient and representative (if any) have a right to be informed of the agency's policies for transfer and discharge if the physician and agency agree that the outcomes and goals have been achieved and the patient no longer needs the agency services. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: The intake specialist provided an admission packet for review on 04/11/2022. The agency notice of patient rights failed to include the patient and representative (if any) have a right to be informed of the agency's policies for transfer and discharge if the physician and agency agree that the outcomes and goals have been achieved and the patient no longer needs the agency services. On 04/11/2022 at 12:10 PM, the intake specialist stated that the agency’s discharge and transfer policy will be added to the admission packets. On 04/13/2022 at 2:40 PM, the administrator acknowledged issues with patient rights. No further documentation provided.

Patient refuses services CFR(s): 484.50(d)(4) The patient refuses services, or elects to be transferred or discharged; This ELEMENT is not met as evidenced by: Based on review of the agency's current patient rights information and interview, the agency failed to provide written notice of patient rights to include that the patient and representative (if any) have a right to be informed of the agency's policies for transfer and discharge when the patient refuses services or elects to be transferred or discharged. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: The intake specialist provided an admission packet for review on 04/11/2022. The agency notice of patient rights failed to include that the patient and representative (if any) have a right to be informed of the agency's policies for transfer and discharge when the patient refuses services or elects to be transferred or discharged. On 04/11/2022 at 12:10 PM, the intake specialist stated that the agency’s discharge and transfer policy will be added to the admission packets. On 04/13/2022 at 2:40 PM, the administrator acknowledged issues with patient rights. No further documentation provided.

Before discharge for cause HHA must: CFR(s): 484.50(d)(5) The HHA determines, under a policy set by the HHA for the purpose of addressing discharge for cause that meets the requirements of paragraphs (d)(5)(i) through (d)(5)(iii) of this section, that the patient's (or other persons in the patient's home) behavior is disruptive, abusive, or uncooperative to the extent that delivery of care to the patient or the ability of the HHA to operate effectively is seriously impaired. The HHA must do the following before it discharges a patient for cause: This ELEMENT is not met as evidenced by: Based on review of the agency's current patient rights information and interview, the agency failed to include that the agency policy for discharge for cause: - Determines that the patient's or other persons in the home, behavior is disruptive, abusive or uncooperative to extent that the delivery of care to the patient or the ability of the agency to operate effectively is impaired; and - Then the agency must follow the requirements of paragraphs (d) (5) (i) through (d) (5) (iii) of this section. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: The intake specialist provided an admission packet for review on 04/11/2022. The agency notice of patient rights and other information given to a patient during the initial visit contained no written information regarding the patient rights when the agency determines that the patient's or other persons in the home, behavior is disruptive, abusive or uncooperative to extent that the delivery of care to the patient or the ability of the agency to operate effectively is impaired and the patient is being considered for discharge for cause. On 04/11/2022 at 12:10 PM, the intake specialist stated that the agency’s discharge and transfer policy will be added to the admission packets. On 04/13/2022 at 2:40 PM, the administrator acknowledged issues with patient rights. No further documentation provided.

Advise the patient of discharge for cause CFR(s): 484.50(d)(5)(i) (i) Advise the patient, representative (if any), the physician(s) or allowed practitioner(s), issuing orders for the home health plan of care, and the patient's 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) that a discharge for cause is being considered; This ELEMENT is not met as evidenced by: Based on review of the agency's current patient rights information and interview, the agency failed to provide written notice of patient rights to include that the agency must advise the patient or representative, physicians, and healthcare professionals who will be responsible for providing care after discharge, that a discharge for cause is being considered. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: The intake specialist provided an admission packet for review on 04/11/2022. The agency notice of patient rights and other information given to a patient during the initial visit contained no written information regarding that the agency must advise the patient or representative, physicians, and healthcare professionals who will be responsible for providing care after discharge, that a discharge for cause is being considered. On 04/11/2022 at 12:10 PM, the intake specialist stated that the agency’s discharge and transfer policy will be added to the admission packets. On 04/13/2022 at 2:40 PM, the administrator acknowledged issues with patient rights. No further documentation provided.

Make efforts to resolve the problem(s) CFR(s): 484.50(d)(5)(ii) (ii) Make efforts to resolve the problem(s) presented by the patient's behavior, the behavior of other persons in the patient's home, or situation; This ELEMENT is not met as evidenced by: Based on review of the agency's current patient rights information and interview, the agency failed to provide written notice of patient rights to include the agency must make efforts to resolve the problem(s) presented by the patient’s behavior, the behavior of other person’s in the patient’s home, or situation. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: The intake specialist provided an admission packet for review on 04/11/2022. The agency notice of patient rights and other information given to a patient during the initial visit contained no written information regarding the agency must make efforts to resolve the problem(s) presented by the patient’s behavior, the behavior of other person’s in the patient’s home, or situation. On 04/11/2022 at 12:10 PM, the intake specialist stated that the agency’s discharge and transfer policy will be added to the admission packets. On 04/13/2022 at 2:40 PM, the administrator acknowledged issues with patient rights. No further documentation provided.

Provide contact info other services CFR(s): 484.50(d)(5)(iii) (iii) Provide the patient and representative (if any), with contact information for other agencies or providers who may be able to provide care; and This ELEMENT is not met as evidenced by: Based on review of the agency current patient rights information and interview, the agency failed to provide written notice of patient rights to include that if the patient is being considered for discharge for cause, the agency must provide the patient and representative (if any), with contact information for other agencies or providers who may be able to provide care after discharge. The deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: The intake specialist provided an admission packet for review on 04/11/2022. The agency notice of patient rights and other information given to a patient during the initial visit contained no written information regarding the patient's right to be informed about the agency's policy to provide the patient and representative (if any) with contact information for other agencies or providers who may be able to provide care after discharge, if patient is being considered for discharge for cause. On 04/11/2022 at 12:10 PM, the intake specialist stated that the agency’s discharge and transfer policy will be added to the admission packets. On 04/13/2022 at 2:40 PM, the administrator acknowledged issues with patient rights. No further documentation provided.

Document efforts to resolve problems CFR(s): 484.50(d)(5)(iv) (iv) Document the problem(s) and efforts made to resolve the problem(s), and enter this documentation into its clinical records; This ELEMENT is not met as evidenced by: Based on review of the agency's current patient rights information and interview, the agency failed to provide written notice of patient rights to include that the agency must document the problem and efforts made to resolve the problem, if the patient is considered for discharge for cause. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: The intake specialist provided an admission packet for review on 04/11/2022. The agency notice of patient rights and other information given to a patient during the initial visit contained no written information regarding the patient's right to be informed that if the patient is considered for discharge for cause, the agency must document the problem and efforts made to resolve the problem. On 04/11/2022 at 12:10 PM, the intake specialist stated that the agency’s discharge and transfer policy will be added to the admission packets. On 04/13/2022 at 2:40 PM, the administrator acknowledged issues with patient rights. No further documentation provided.

Death of patient CFR(s): 484.50(d)(6) The patient dies; or This ELEMENT is not met as evidenced by: Based on review of the agency's current patient rights information and interview, the agency failed to provide written notice of patient rights to include that the patient and representative (if any) have a right to be informed of the agency's policies for transfer and discharge if the patient dies. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: The intake specialist provided an admission packet for review on 04/11/2022. The agency notice of patient rights and other information given to a patient during the initial visit contained no written information regarding that the patient and representative (if any) have a right to be informed of the agency's policies for transfer and discharge if the patient dies. On 04/11/2022 at 12:10 PM, the intake specialist stated that the agency’s discharge and transfer policy will be added to the admission packets. On 04/13/2022 at 2:40 PM, the administrator acknowledged issues with patient rights. No further documentation provided.

HHA ceases to operate CFR(s): 484.50(d)(7) The HHA ceases to operate. This ELEMENT is not met as evidenced by: Based on review of the agency's current patient rights information and interview, the agency failed to provide written notice of patient rights to include the patient and representative (if any) have a right to be informed of the agency's policies for transfer and discharge if the agency ceases to operate. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: The intake specialist provided an admission packet for review on 04/11/2022. The agency notice of patient rights and other information given to a patient during the initial visit contained no written information regarding that the patient and representative (if any) have a right to be informed of the agency's policies for transfer and discharge if the agency ceases to operate. On 04/11/2022 at 12:10 PM, the intake specialist stated that the agency’s discharge and transfer policy will be added to the admission packets. On 04/13/2022 at 2:40 PM, the administrator acknowledged issues with patient rights. No further documentation provided.

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 clinical record review, home visit observation, and interview, the agency failed to ensure that a complete and accurate patient specific comprehensive assessment was completed for each patient. The agency failed to: - Ensure that the initial assessment of the patient was within 48 hours of the referral to home care, or 48 hours after the patient's return home, or on the physician ordered start of care date (G514); - Ensure that the comprehensive assessment adequately reflected the patient's current health, psychosocial, functional, and cognitive status (G528); - Ensure that the patient’s medical, nursing, rehabilitation, social, and discharge planning needs were met (G534); - Ensure the performance of an accurate and ongoing drug regimen review that included all medications the patient was currently taking (G536); and - Ensure that comprehensive assessment was updated at discharge that included a summary of the patient’s progress in meeting the care plan goals (G550). The cumulative effects of these deficient practices has the potential to effect all patients served by the home health agency. .

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on clinical record review and interview, the agency failed to conduct the initial assessment of the patient within 48 hours of the referral to home care, or 48 hours after the patient's return home, or on the physician ordered start of care date in four (Records/Patients #1, #3, #4 and #5) of five full records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: RECORD/PATIENT #1: Review of the clinical record showed: - Referral for home health services on 09/20/2019; - The comprehensive OASIS (Outcome and Assessment Information Set - a required set of assessment data submitted to Medicare and Medicaid Services) assessment performed (documentation not finalized) for the start of care on 09/26/2019 at 10:25 AM; and - On 12/12/2019 (2 months and 2 weeks after start of care) at 12:28 PM, the SOC comprehensive OASIS assessment was electronically signed by a previous RN (registered nurse). RECORD/PATIENT #3: Review of the clinical record showed: - Referral for home health services on 03/19/2019; - The comprehensive OASIS assessment performed (documentation not finalized) for the start of care on 03/22/2019 at 10:15 AM; and - On 06/26/2019 (3 months after start of care) at 4:08 PM, the SOC comprehensive OASIS assessment was electronically signed by a previous RN (registered nurse). RECORD/PATIENT #4: Review of the clinical record showed: - Referral for home health services on 10/18/2021; - The comprehensive OASIS assessment performed (documentation not finalized) for the start of care on 10/21/2021 at 10:00 AM; and - On 11/30/2021 (1 month and 1 week after start of care) at 12:45 PM, the SOC comprehensive OASIS assessment was electronically signed by a previous RN (registered nurse). RECORD/PATIENT #5: Review of the clinical record showed: - Referral for home health services on 06/03/2021; - The comprehensive OASIS assessment performed (documentation not finalized) for the start of care on 06/22/2021 at 11:00 AM; and - On 07/03/2021 at 2:10 PM, the SOC comprehensive OASIS assessment was electronically signed by a previous RN (registered nurse). During an interview on 04/13/2022 at 11:25 AM, the interim clinical manager stated that he/she was unsure of why the SOC visits were completed late. No further documentation provided.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on clinical record review and interview, the agency failed to ensure the patient's current health status was assessed and documented in two (Patients/Records #1 and #3) of five records reviewed. This deficient practice has the potential to affect the identification of patient needs for all patients on service with the agency. Findings included: RECORD/PATIENT #1: Review of the clinical record showed the following: - The comprehensive OASIS (Outcome and Assessment Information Set - a required set of assessment data submitted to Medicare and Medicaid Services) assessment performed (documentation not finalized) for the start of care on 09/26/2019 at 10:25 AM; - On 12/12/2019 (2 months and 2 weeks after start of care) at 12:28 PM, the SOC comprehensive OASIS assessment was electronically signed by a previous RN (registered nurse); - Patient had diagnosis of neuromuscular dysfunction of bladder (nerves and muscles do not work well together causing the bladder to not fill or empty properly), requiring urinary catheter (tube inserted into the bladder that allows for urine to drain); - No documentation of when catheter was last changed or due to be changed next; - The plan of care (POC) dated 09/29/2019 to 11/24/2019 was signed by urologist on 12/20/2019 (2 months and 3 weeks after POC start date) with a “urology orders only” written by the urologists under the signature; - POC ordered SN (skilled nurse) to change suprapubic catheter monthly and prn (as needed); and - No documentation of when the last catheter change was or when the next catheter change is was due. RECORD/PATIENT #3: Review of the clinical record showed the following: - The comprehensive OASIS assessment performed (documentation not finalized) for the start of care on 03/22/2019 at 10:15 AM; - On 06/26/2019 (3 months after start of care) at 4:08 PM, the SOC comprehensive OASIS assessment was electronically signed by a previous RN (registered nurse); - Patient had diagnosis of urethral stricture (scarring that narrows the tube that carries urine out of the body), requiring urinary catheter (tube inserted into the bladder that allows for urine to drain); - No assessment documentation for genitourinary tract for elimination status and/or catheter details; - Genitalia/Reproductive status showed “not assessed” check marked; - OASIS M1340 question regarding patient having a surgical wound showed, “yes, patient has at least one observable surgical wound” answered; - Wound assessment section showed N/A (not applicable) check marked; and - No documentation of the last catheter change or when the next catheter change was due. During an interview on 04/13/2022 at 11:55 AM, the interim clinical manager (CM) stated that he/she was unaware of the above findings. No further documentation provided.

Patient's needs CFR(s): 484.55(c)(4) The patient's medical, nursing, rehabilitative, social, and discharge planning needs; This ELEMENT is not met as evidenced by: Based on clinical record review and interview, the agency failed to ensure the patient’s medical, nursing, rehabilitation, social, and discharge planning needs were met in three (Records/Patients #1, #3, and #5) of five records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: RECORD/PATIENT #1: Review of the clinical record showed the following: - The comprehensive OASIS (Outcome and Assessment Information Set - a required set of assessment data submitted to Medicare and Medicaid Services) assessment performed (documentation not finalized) for the start of care on 09/26/2019 at 10:25 AM; - On 12/12/2019 at 12:28 PM, the SOC comprehensive OASIS assessment was electronically signed by a previous RN (registered nurse); - Patient had diagnosis of neuromuscular dysfunction of bladder (nerves and muscles do not work well together causing the bladder to not fill or empty properly), requiring urinary catheter (tube inserted into the bladder that allows for urine to drain); - No documentation of when catheter was last changed or due to be changed next; - The plan of care (POC) dated 09/29/2019 to 11/24/2019 was signed by urologist on 12/20/2019 with a “urology orders only” written by the urologists under the signature; - POC has SN (skilled nurse) to change suprapubic catheter monthly and prn (as needed); and - No documentation of when the last catheter change was completed or when the next catheter change was due. RECORD/PATIENT #3: Review of the clinical record showed the following: - The comprehensive OASIS assessment performed (documentation not finalized) for the start of care on 03/22/2019 at 10:15 AM; - On 06/26/2019 at 4:08 PM, the SOC comprehensive OASIS assessment was electronically signed by a previous RN (registered nurse); - Patient had diagnosis of urethral stricture (scarring that narrows the tube that carries urine out of the body), requiring urinary catheter (tube inserted into the bladder that allows for urine to drain); - No assessment documentation for genitourinary tract for elimination status and/or catheter details; - Genitalia/Reproductive status showed “not assessed” check marked; - OASIS M1340 question regarding patient having a surgical wound showed, “yes, patient has at least one observable surgical wound” answered; - Wound assessment section showed N/A (not applicable) check marked; and - No documentation of the last catheter change or when the next catheter change was due. RECORD/PATIENT #5: Review of the plan of care, dated 06/22/2021 to 08/20/2021, showed, in part: - Diagnoses of spastic hemiplegia affecting right dominant side (part of the brain controlling movement is damaged), convulsions (uncontrollable muscle contractions), hypertension (the force of the blood against the artery walls is too high), type 2 diabetes mellitus without complications (a chronic condition that affects the way the body processes blood sugar), and apraxia (the brain is unable to make and deliver correct movement instructions to the body); - SN (skilled nurse) visit frequency1w1 (1 time weekly for 1 week) to assess and evaluate for treatment; - PT (physical therapy) visit frequency 1w1 to assess and evaluate for treatment; - Patient goals included; to be safe in home, increase strength and endurance, decrease spasticity, be ambulatory, and decrease pain; and - POC failed to include patient specific interventions and treatments to reach goals. During an interview on 04/13/2022 at 11:55 AM, the interim clinical manager (CM) acknowledged the findings. No further documentation provided.

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, home visit observation, and interview, the agency failed to review all of the patient's current medications to maintain an accurate/updated medication profile in, but not limited to, two (Records/Patients #1 and #2) of two home visit observations. This deficient practice has the potential to affect all patients served by the agency. Findings included: RECORD/PATIENT #1: Review of the plan of care dated 03/14/2022 through 05/12/2022 showed in part: - APAP (acetaminophen; pain reliever/fever reducer) 325mg, 1 tablet every 4 hours oral as needed; - Oxybutynin Chloride (bladder relaxer used to treat overactive bladder) 10mg, 1 tablet every day; - Metamucil (fiber supplement that helps promote bowel movements), every day oral prn (as needed) for constipation; and - Ibuprofen (non-steroidal anti-inflammatory drug used to treat pain) 200mg, 1 tablet 4 times a day oral as needed for pain. During a home visit on 04/12/2022 at 11:00 AM, the following medication discrepancies were identified: - APAP 500mg. 1-2 tablets every 4 hours oral as needed; - Oxybutynin Chloride 15mg, 1 tablet every day; - Patient is not taking Metamucil for constipation; and - Patient is not taking Ibuprofen 200mg, 1 tablet 4 times a day oral as needed for pain. RECORD/PATIENT #2: Review of the POC dated 04/01/2022 to 05/30/2022 showed, in part, the following medications (the agency did not provide a medication profile): - Insulin glargine (long acting insulin), subcutaneous take 15 units at night daily; and - Ursodiol (cholesterol medication) 250 mg, one tablet, twice a day with meals. During the patient's home visit observation on 04/11/2022 at 1:37 PM, the patient's caregiver provided a medication list from the hospital dated 03/07/2022 at 6:54 PM, and showed the following discrepancies: - Stop taking amlodipine (used to treat high blood pressure) 5 milligrams (mg) and oxycodone (used to treat moderate to severe pain) 5 mg; - Start taking Augmentin (used to treat infection) and loperamide (control and relieve the symptoms of acute diarrhea) (Augmentin and loperamide was not listed on the plan of care); - Amlodipine (treats high blood pressure and chest pain) 5 mg one tablet every day (this was listed on the patient's medication list from the hospital and the patient was instructed to stop taking); - Dicyclomine (can treat irritable bowel syndrome) 20 mg every six hours as needed for pain (not on the plan of care); - Oxycodone 5 mg one tablet every six hours as needed for pain (this was on the patient's medication list from the hospital and the patient was instructed to stop taking); - Rivaroxaban (treats and prevents blood clots) 20 mg, one tablet once a day (not on the plan of care); - Irbesartan (treats high blood pressure and can treat diabetic neuropathy) 300 mg, one tablet at bedtime, one to five of each chemotherapy cycle (not on the plan of care); - Olanzapine (antipsychotic) 5 mg, one tablet at hour of sleep (not on the plan of care); - Nystatin (use for fungal skin infections) 100,000 unit/gram topical powder to affected areas of skin four times a day as needed (not on the plan of care); - Lidocaine/Prilocaine (causes numbness or loss of feeling before medical procedures) topical cream to affected area as needed, apply topically to port site 15 to 30 minutes prior to access (not on the plan of care); - Dexamethasone (relieves inflammation) 4 mg, one tablet with breakfast on days two, three, and four following each chemotherapy cycle. Do not use after 6:00 PM to avoid insomnia (not on the plan of care); - Zofran (antiemetic) 8 mg every eight hours as needed for nausea and vomiting (not on the plan of care); - Prochlorperazine maleate (Compazine) (used to treat schizophrenia and anxiety and to relieve severe nausea and vomiting) 10 mg, one tablet every six hours as needed for nausea if not controlled by Zofran (not on the plan of care); - Lorazepam (antianxiety) 0.5 mg, one to two tablets every six hours as needed for nausea and vomiting not controlled by Zofran or Compazine, may use every six hours as needed for anxiety or at bedtime for insomnia (not on the plan of care); - Flash glucose sensor (Freestyle Libre 14 day sensor miscellaneous) (a continuous glucose monitoring system consisting of a app or handheld reader and a glucose sensor worn on the back of the upper arm) use as directed (not on the plan of care); - Cod liver oil (dietary supplement), one capful every day (not on the plan of care); - Cholecalciferol (vitamin D3) 50 micrograms (mg) (2,000 u) one time a day (not on the plan of care); - Ciclopirox (used to treat fungal skin infections) .77% topical cream to affected area twice a day for underarm rash as needed (not on the plan of care); - Empagliflozin (antidiabetic medication) 10 mg every day (not on the plan of care); - Insulin degludec (ultralong-acting insulin) 100 u/ml (3 ml) injection pen, 24 u subcutaneous at bedtime not on the plan of care); - Test blood glucose twice a day (not on the plan of care); - There was no insulin glargine listed on the medication list from the hospital; - Vitamin E (supplement) 1000 u, one tablet every day (not on the plan of care); and - Ursodiol 30 mg, one tablet every 12 hours (the plan of care showed Urosiol 250 mg, one tablet every 12 hours). During interview on 04/11/2022 at 1:37 PM, the patient’s caregiver stated that: - The hospital list of medications provided was the correct medications the patient was currently taking; - They no longer use the oxycodone because it bothers the patient; - They use topical creams at times; - The patient’s blood sugar is checked six to eight times a day; and - The antibiotic was just finished.

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 the comprehensive assessment was updated at discharge that included a summary of the patient’s progress in meeting the care plan goals, in two (Records/Patients #3 and #5) of three discharge records reviewed. This deficient practice has the potential to affect the post discharge medication accuracy for all the agency's patients. Findings included: RECORD/PATIENT #3: Review of a discharge comprehensive OASIS (Outcome and Assessment Information Set - a required set of assessment data submitted to Medicare and Medicaid Services), dated 11/05/2021, showed: - Discharge visit date on 11/05/2021 at 4:00 PM; - Discharge OASIS documentation was completed with electronic signature on 03/15/2022 (4 months after discharge visit) at 3:56 PM; - No discharge summary included with discharge OASIS; and - No documentation of physician being notified and/or discharge summary being sent to physician. During an interview on 04/13/2022 at 11:25 AM, the interim clinical manager stated: - Oasis documentation completed on 03/15/2022 for the discharge visit on 11/05/2021 because the discharge was backdated to the last date of the episode in which the agency had signed orders for; - Visits made after 11/05/2021 were not billed for since the physician would not sign the orders; and - No discharge summary completed and/or sent to physician. RECORD/PATIENT #5: Review of a discharge comprehensive OASIS, dated 08/13/2021, showed: - Discharge visit date on 08/13/2021 at 4:00 PM; - Discharge OASIS documentation was completed with electronic signature on 03/15/2022 (7 months after discharge visit) at 4:11 PM; - No discharge summary included with discharge OASIS; and - No documentation of physician being notified and/or discharge summary being sent to physician. During an interview on 04/13/2022 at 11:25 AM, the interim clinical manager stated: - Unsure why OASIS documentation was not completed until 03/15/2022 when patient was discharged on 08/13/2021; and - No discharge summary completed and/or sent to physician.

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 meet the requirements of 484.58 Condition of Participation: Discharge Planning, when the agency: - Failed to implement an effective discharge planning process (G562); and - Failed to document/send all necessary medical information to the receiving facility or health care practitioner to ensure the safe and effective transition of care (G564). The cumulative effect of these deficient practices has the potential to affect the care of all patients served by the agency.

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 patients received effective discharge planning in two (Records/Patients #3 and #5) of three discharge records reviewed. This deficient practice has the potential to affect the post discharge needs for all patients served by the agency. Findings included: RECORD/PATIENT #3: Review of the plan of care, dated 09/07/2021 to 11/05/2021, showed, in part: - Diagnoses of anterior urethral stricture (scarring that narrows the tube that carries urine out of the body), long term (current) use of anticoagulants (blood thinner), legal blindness, and history of pulmonary embolism (blood clot in lung); - SN (Skilled Nurse) visit frequency 1MO2 + 2 PRN (1 time a month for 2 months with 2 as needed visits); and - SN urinary catheter (tube inserted into the bladder that allows for urine to drain) care with monthly catheter change. Review of a SN visit, dated 10/07/2021 at 4:30 PM, showed: - SN monthly visit (last visit prior to discharge visit); - Dependent on caregivers and requires 24 hour supervision; - Supra pubic catheter changed by SN (No education for urinary catheter care or maintenance); and - Treatment plan changes with “goals not met” and no discharge planning. Review of a discharge comprehensive OASIS (Outcome and Assessment Information Set), dated 11/05/2021, showed: - Discharge visit date on 11/05/2021 at 4:00 PM; - Discharge disposition (M2420) question regarding where the patient is after the discharge, answered with “Patient remained in the community with formal assistive services” (No detail documented in the clinical record on formal services); - Discharge OASIS question on self-care (GG0130) on toileting (section C) has answered that the patient requires assistance with toileting (No documentation of patient education with urinary catheter care and/or management after discharge); and - No documentation of discharge planning prior to patient being discharged. During an interview on 04/13/2022 at 11:25 AM, the interim clinical manager stated: - Physician refused to sign home health orders due to patient not following up in physician office (No documentation of physician communication); and - Patient now received monthly catheter changes at physician office (No documentation to support plan for catheter care after discharge). RECORD/PATIENT #5: Review of the clinical record showed, in part: - Diagnoses of spastic hemiplegia (part of the brain controlling movement is damaged) affecting right dominant side, convulsions (uncontrollable muscle contractions), hypertension (the force of blood against the artery walls is too high), type 2 diabetes mellitus (a disease in which the body's ability to produce or respond to the hormone insulin is impaired, resulting in abnormal metabolism of glucose) without complications, and apraxia (brain unable to make and deliver correct movement instructions to the body); - SN SOC (start of care) visit on 06/22/2021 at 11:00 AM showed “assist of spouse with physician supervision” documented for discharge planning; - SN discharge OASIS visit on 08/13/2021 at 4:00 PM, showed patient requires assistance with all ADL’s (activities of daily living); and - No documentation of patient/caregiver education and discharge planning. During an interview on 04/12/2022 at 9:58 AM, the interim clinical manager stated: - Patient is to be notified prior to discharge; - Patient education is to be provided prior to discharge; and - The agency used to document education provided prior to discharge but not documenting at this time.

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 review and interview, the agency failed to ensure a discharge summary that included all necessary information pertaining to the patient's current course of illness and treatment, post-discharge goals of care and treatment preferences was sent to the patient's health care practitioner to ensure the safe and effective transition of care for two (Records/Patients #3 and #5) of three discharge records reviewed. Findings included: RECORD/PATIENT #3: Review of a discharge comprehensive OASIS (Outcome and Assessment Information Set - a required set of assessment data submitted to Medicare and Medicaid Services), dated 11/05/2021, showed: - Discharge visit date on 11/05/2021 at 4:00 PM; - Discharge OASIS documentation completed with electronic signature on 03/15/2022 (4 months after discharge visit) at 3:56 PM; - No discharge summary included with discharge OASIS; and - No documentation of physician being notified and/or discharge summary being sent to physician. During an interview on 04/13/2022 at 11:25 AM, the interim clinical manager stated that: - OASIS documentation completed on 03/15/2022 for the discharge visit on 11/05/2021 because the discharge was backdated to the last date of the episode in which the agency had signed orders for; - Visits made after 11/05/2021 were not billed since the physician would not sign the orders; and - No discharge summary completed and/or sent to physician. RECORD/PATIENT #5: Review of a discharge comprehensive OASIS, dated 08/13/2021, showed: - Discharge visit date on 08/13/2021 at 4:00 PM; - Discharge OASIS documentation completed with electronic signature on 03/15/2022 (7 months after discharge visit) at 4:11 PM; - No discharge summary included with discharge OASIS; and - No documentation of physician being notified and/or discharge summary being sent to physician. During an interview on 04/13/2022 at 11:25 AM, the interim clinical manager stated: - Unsure why OASIS documentation was not completed until 03/15/2022 when patient was discharged on 08/13/2021; and - No discharge summary completed and/or sent to physician.

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, home visit observation, and interview, the agency failed to: -Ensure each patient received an individualized plan of care which included a description of the patient's risk for emergency department visits and hospital re-admissions and goals identified by the patient (G574); - Ensure drugs, services, and treatments administered only as ordered by a physician (G580); - Ensure a revised plan of care reflects 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 home health agency and patient in the plan of care (G592); and - Ensure each patient receives accurate medication schedule/instructions to the patient (G616); .

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 (POC) included all of the required elements in, but not limited to, one (Record/Patient #2) of two home visit observations. This deficient practice has the potential to affect the care of all patients served by the agency. Findings included: RECORD/PATIENT #1: Review of hospital home health orders dated 03/30/2022 at 3:13 PM, showed the following: - Teach patient and/or caregiver medication management and compliance; - Monitor and teach pain management and pain medication compliance when necessary; - Monitor and teach signs and symptoms of infection; - Monitor and teach disease management, including signs and symptoms; -Monitor and teach diet; - Monitor and teach when to call; - Monitor and teach hospital readmission avoidance; and - The plan of care (POC) failed to include individualized interventions of medication management, bleeding and anti-coagulant precautions, pain management, infection, disease management, diet, when to notify the physician, and hospital readmission avoidance. Review of the POC dated 04/01/2022 to 05/30/2022 showed: - Diagnosis included malignant neoplasm (a new and abnormal growth of tissue) of body of pancreas, secondary hypertension (high blood pressure), and diabetes (a disease in which the body's ability to produce or respond to the hormone insulin is impaired, resulting in abnormal metabolism of carbohydrates and elevated levels or glucose in the blood and urine) due to underlying condition; - Skilled nurse to monitor home safety, medication compliance, and home bound status; - Insulin aspart (short acting insulin) subcutaneous (under the skin) zero to six units (sliding scale- refers to the progressive increase in the pre-meal or nighttime insulin dose, based on pre-defined blood glucose ranges) before meals and at bedtime; - Bleeding and anti-coagulant (blood thinner) precautions - Assess infection control; - Risk for hospitalization: Unintentional weight loss of a total of 10 pounds more in the past 6 months, multiple hospitalizations/emergency department visits (2 or more) in the past six months, currently taking five or more medications, and reports exhaustion; - Physical therapy to evaluate and treat during certification period; - Goals: Vital signs stable and diabetes controlled, minimal to no pain, increased strength and endurance, increased understanding of disease processed and management of such; and - The plan of care failed to provide individualized interventions for infection control, medication teaching, sliding scale insulin, vital sign parameters, weight loss, diabetes, pain, physical therapy, and understanding of disease process and management. During the home visit observation with the occupational therapist (OT) on 04/11/2022 at 1:37 PM, showed the following: - The patient said he/she wanted the blood pressure taken in his/her left arm because he/she wears a Libre (a flash glucose monitoring system measures your sugar (glucose) levels all the time throughout the day) and it was in his/her right arm; - He/she rated his/her pain a three (pain scale used to rate pain from zero, representing no pain to ten representing the worst pain possible) in the right chest area and breathing in made it worst; - OT assessed the patient’s right upper chest where his/her port-a-cath (a device placed under the skin and is attached to a catheter that is guided into a large vein above the right side of the heart, usually in the right side of chest and used to draw blood and give treatments); and - The plan of care failed to include vital sign parameters, Libre, port-a-cath, and pain. During an interview on 4/11/2022 at 1:37 PM, the patient and his/her caregiver stated that: - The patient takes Aleve (treats fever or pain) for pain, which is effective; - The patient started taking Amoxicillin (antibiotic to treat infections) and just finished the antibiotic; - Uses a topical ointment for rash as needed; - Occasionally has swelling in bilateral extremities; - Received chemotherapy for pancreatic cancer and waiting on a procedure for radiation and the chemotherapy was on hold until after the radiation; - The physician gave the patient blood sugar parameters and he/she already told the nurse the parameters; and - The plan of care failed to include individualized interventions for pain, the use of Aleve, topical ointment as needed for rash, swelling in bilateral extremities, chemotherapy and radiation, and blood sugar parameters. During an interview on 04/13/2022 at 10:55 AM, the interim clinical director stated that: - The plan of care was not individualized; and - The software program the agency used was “broad” and the agency staff should be able to add individualized interventions.

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 clinical record review and interview, the agency failed to ensure staff obtained physician signed plans of care for orders and treatments and verbal or telephone orders in a timely manner which affected two (Records/Patients #4 and #5) of three discharge records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: RECORD/PATIENT #4: Review of the POC dated 10/21/2021 through 12/19/2021 showed: - Diagnosis included multiple sclerosis, and hypertension; - Skilled nurse (SN) the week of 10/21/2021, 1w1 (visit one time a week for one week), and the week of 11/10/21 1w1 to assess bladder status and obtain an urinalysis; - Physical therapy (PT) 1w4 (visit one time a week for four weeks) to evaluate and treatment for equipment and teaching; and - Signed by the physician on 01/07/2022, signed two months and 17 days after the initial start of care (SOC). Review of the occupational therapy (OT) evaluation dated 10/27/2021 at 12:40 PM showed: - OT 1w4; and - The physician signed the evaluation on 01/27/2022 (signed 3 months after the evaluation). RECORD/PATIENT #5: Review of the POC dated 06/22/2021 through 08/20/2021 showed: - Diagnoses of spastic hemiplegia affecting right dominant side (part of the brain controlling movement is damaged), convulsions (uncontrollable muscle contractions), hypertension (the force of the blood against the artery walls is too high), type 2 diabetes mellitus without complications (a chronic condition that affects the way the body processes blood sugar), and apraxia (the brain is unable to make and deliver correct movement instructions to the body); - SN (skilled nurse) visit frequency1w1 to assess and evaluate for treatment; - PT (physical therapy) visit frequency 1w1 to assess and evaluate for treatment; - Patient goals included; to be safe in home, increase strength and endurance, decrease spasticity, be ambulatory, and decrease pain (No interventions or treatments on POC for goals); - Electronic signature date of 07/22/2021 at 3:24 PM from previous RN; and - Physician never signed the POC. During an interview on 04/12/2022 at 9:58 AM, interim clinical manager stated that they have issues getting the physicians to sign the POC. RECORD/PATIENT #5: Review of the POC dated 06/22/2021 through 08/20/2021 showed: - Diagnoses of spastic hemiplegia affecting right dominant side (part of the brain controlling movement is damaged), convulsions (uncontrollable muscle contractions), hypertension (the force of the blood against the artery walls is too high), type 2 diabetes mellitus without complications (a chronic condition that affects the way the body processes blood sugar), and apraxia (the brain is unable to make and deliver correct movement instructions to the body); - SN (skilled nurse) visit frequency1w1 (1 time weekly for 1 week) to assess and evaluate for treatment; - PT (physical therapy) visit frequency 1w1 to assess and evaluate for treatment; - Patient goals included; to be safe in home, increase strength and endurance, decrease spasticity, be ambulatory, and decrease pain (No interventions or treatments on POC for goals); - Electronic signature date of 07/22/2021 at 3:24 PM from previous RN; and - Physician never signed the POC.

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, the agency failed to ensure that a revised plan of care reflected current information from the patient’s updated and contained information concerning the patient’s progress toward goals, in one (Record/Patient #3) of three discharge records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: RECORD/PATIENT #3: Review of the Plan of Care (POC) dated 03/22/2019 to 05/20/2019, showed, in part: - The patient was admitted to home health services on 03/22/2019; - Patient had primary diagnosis of urethral stricture (scarring that narrows the tube that carries urine out of the body), requiring urinary catheter (tube inserted into the bladder that allows for urine to drain); - Other diagnoses included, long term (current) use of anticoagulants (blood thinner), legal blindness, and history of pulmonary embolism (blood clot in lung); - SN visit frequency1w9 (1 time weekly for 9 weeks); - SN foley care with monthly foley change; - Skin and pain assessment; - SN to assess vital signs with pulse ox; - SN to evaluate impaired integumentary status of surgical site as ordered until healed (no order details documented); - Ciprofloxacin HCI (antibiotic used to treat infection) 250mg (milligrams) every day oral (no documentation of why patient taking antibiotic); - SN to evaluate weekly for confusion; - The POC dated 03/22/2019 to 05/20/2019, failed to show: ** Catheter supplies; ** Detailed orders for catheter changes; and ** Surgical site details including location, assessment, and care. Review of the OASIS (Outcome and Assessment Information Set), dated 03/22/2019, showed: - The comprehensive OASIS assessment performed (documentation not finalized) for the start of care on 03/22/2019 at 10:15 AM; - On 06/26/2019 (3 months after SOC) at 4:08 PM, the SOC comprehensive OASIS assessment was electronically signed by a previous RN (registered nurse); - No assessment documentation for genitourinary tract for elimination status and/or catheter details; - Genitalia/Reproductive status has “not assessed” check marked; - Oasis M1340 question regarding patient having a surgical wound has, “yes, patient has at least one observable surgical wound” answered; - Wound assessment section has N/A (not applicable) check marked; and - No documentation of the last catheter change or when the next catheter change is due. Review of the POC dated 09/07/2021 to 11/05/2021, showed, in part: - The patient was admitted to home health services on 03/22/2019; - Patient had primary diagnosis of urethral stricture (scarring that narrows the tube that carries urine out of the body), requiring urinary catheter (tube inserted into the bladder that allows for urine to drain); - Other diagnoses included, long term (current) use of anticoagulants (blood thinner), legal blindness, and history of pulmonary embolism (blood clot in lung); - SN visit frequency 1MO2 + 2prn (1 time monthly for 2 months plus 1 as needed visits); - SN foley care with monthly foley change; - Skin and pain assessment; - SN to assess vital signs with pulse ox; - SN to evaluate impaired integumentary status of surgical site as ordered until healed (no update to POC to remove intervention of surgical site); - Ciprofloxacin HCI 250mg every day oral (no update to medication list to reflect patient no longer on antibiotic); and - SN to evaluate weekly for confusion (SN visit frequency is no longer weekly). Review of the recertification OASIS (Outcome and Assessment Information Set), dated 09/02/2021, showed: - The comprehensive OASIS assessment performed (documentation not finalized) for the start of care on 09/02/2021 at 4:35 PM; - On 09/21/2021 at 8:54 PM, the SOC comprehensive OASIS assessment was electronically signed by a previous RN (registered nurse); - Patient assessed for confusion and orientation status documented with easily confused, forgetful, and memory deficits (POC has SN to assess for confusion weekly and SN only doing visits 1 time a month); - Oasis M1340 question regarding patient having a surgical wound has “no” answered (POC not updated to reflect this); - Wound assessment section has N/A (not applicable) check marked; and - Summary section has plan of care teaching for s/s of UTI’s (signs and symptoms of urinary tract infections) noted (not on POC). During an interview on 04/13/2022 at 11:25 AM, the interim clinical manager agreed to the findings and stated that the POC did not accurately reflect the patient’s updated status.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on home visit observation and interview, the agency failed to provide the patient/caregiver with a copy of written instructions outlining the patient's medication schedule/ instruction, including the medication's name, dosage, and frequency in one (Record/Patient #2) of two home visit observations. This deficient practice has the potential to affect the patient's knowledge of self -care and agency expectations in all patients served by the agency. Findings included: RECORD/PATIENT #2: During a home observation visit on 04/11/2022 at 1:37 PM, with the occupational therapist, the surveyor observed the patient's home folder. The agency failed to provide written instructions outlining the patient's medication schedule/ instruction, including the medication's name, dosage and frequency. The agency did not provide the requested medication list. On 04/13/19 at 9:50 AM, the above results were reviewed with the interim clinical manager. No additional documentation was provided.

Treatments and therapy services CFR(s): 484.60(e)(3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services. This ELEMENT is not met as evidenced by: Based on home visit observation and interview the agency failed to provide the patient/ caregiver with a copy of written instructions of any treatments being administered by the agency in one (Record/Patient #1) of two home visit observations. This deficient practice has the potential to affect the patient's knowledge of self- care and agency expectations in all patients served by the agency. Findings included: RECORD/PATIENT #1: During a home observation visit on 04/12/2022 at 11:00 AM, with the interim clinical manager, the surveyor observed the patient's home folder. The agency failed to provide written instructions of catheter care and any other treatments administered by the agency. On 04/13/19 at 9:50 AM, the above results were reviewed with the interim clinical manager. No additional documentation was provided.

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 home visit observation and interview, the agency failed to provide in writing the name and contact information of the clinical manager in one (Record/Patient #2) of two home visit observations. This deficient practice has the potential to affect all patients served by the agency. Findings included: RECORD/PATIENT #2: During a home observation visit on 04/11/2022 at 1:37 PM, with the occupational therapist, the surveyor observed the patient's home folder. The agency failed to include the name and contact information of the clinical manager. On 04/13/19 at 9:50 AM, the above results were reviewed with the interim clinical manager. No additional documentation was provided.

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 observation and interview, the agency failed to: - Ensure there was evidence that the agency is measuring, analyzing, and tracking quality indicators (G642); - Ensure the agency used data collected to monitor the effectiveness and safety of the services and quality of care and identifying opportunities for improvement (G644); - Ensure the frequency and detail of the data collection was approved by the agency's governing body (G644); - Ensure the agency implemented performance improvement activities (G646); - Ensure the performance improvement activities focused on high risk, high volume, or problems-prone areas (G648); - Ensure the performance improvement activities tracked adverse patient events, analyzed their causes, and implemented preventive actions (G654); and - Ensure the governing body was responsible for ensuring an ongoing program for quality improvement and patient safety (G660). The cumulative effect of these deficient practices has the potential to affect the quality of care and safety of all agency patients. ..

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 review of agency’s quality assessment performance (QAPI) program and interview, the agency failed to provide evidence that the agency was measuring, analyzing, and tracking quality indicators. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Review of the QAPI program showed the agency failed to have documentation of measurement, analysis, and tracking of quality indicators. The agency failed to use the data to show measurable improvements in indicators and to track quality indicators to assess processes of care, agency services, and operations. During an interview on 04/12/2022 at 8:35 AM, the administrator said his/her clinical manager had just resigned and a nurse that works for the agency will assume the position. The interim clinical manager has worked full time for the agency and is familiar with the QAPI program. During an interview on 04/12/2022 at 9:58 AM, the interim clinical manager stated that he/she had no information on QAPI and was not working on the program. During an interview on 04/13/2022 at 2:41 PM, the administrator stated that the nurse is over all of the programs including QAPI and he/she had no further information.

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 review of agency’s quality assessment performance (QAPI) program and interview, the agency failed to provide evidence that collection of quality data was on going to: - Monitor the effectiveness and safety of the services and quality of care; and - Identify opportunities for improvement. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Review of the QAPI program showed the agency failed to have documentation of on-going monitoring of data. During an interview on 04/12/2022 at 8:35 AM, the administrator said his/her clinical manager had just resigned and a nurse that works for the agency will assume the position. The interim clinical manager has worked full time for the agency and is familiar with the QAPI program. During an interview on 04/12/2022 at 9:58 AM, the interim clinical manager stated that he/she had no information on QAPI and was not working on the program. During an interview on 04/13/2022 at 2:41 PM, the administrator stated that the nurse is over all of the programs including QAPI and he/she had no further information.

Program activities CFR(s): 484.65(c) Standard: Program activities. The HHA's performance improvement activities must-- This STANDARD is not met as evidenced by: Based on review of the agency’s quality assessment performance (QAPI) program and interview, the agency failed to provide evidence that the performance improvement activities were focused on high risk, high volume, or problems-prone areas This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Review of the QAPI program showed the agency failed to have documentation of performance improvement activities that were focused on high risk, high volume, or problems-prone areas. During an interview on 04/12/2022 at 8:35 AM, the administrator said his/her clinical manager had just resigned and a nurse that works for the agency will assume the position. The interim clinical manager has worked full time for the agency and is familiar with the QAPI program. During an interview on 04/12/2022 at 9:58 AM, the interim clinical manager stated that he/she had no information on QAPI and was not working on the program. During an interview on 04/13/2022 at 2:41 PM, the administrator stated that the nurse is over all of the programs including QAPI and he/she had no further information.

High risk, high volume, or problem-prone area CFR(s): 484.65(c)(1)(i) (i) Focus on high risk, high volume, or problem-prone areas; This ELEMENT is not met as evidenced by: Based on review of the agency’s quality assessment performance (QAPI) program and interview, the agency failed to provide evidence of any performance improvement activities that were focused on high risk, high volume, or problems-prone areas. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Review of the QAPI program showed the agency failed to have documentation of performance improvement activities that were: - Focused on high risk, high volume, or problems-prone areas; - Considered the incidence, prevalence, and severity of the problems in those areas; and - Lead to an immediate correction of any identified problem that directly or potentially threatened the health and safety of patients. During an interview on 04/12/2022 at 8:35 AM, the administrator said his/her clinical manager had just resigned and a nurse that works for the agency will assume the position. The interim clinical manager has worked full time for the agency and is familiar with the QAPI program. He/she remembered monitoring performance improvement in the past but he/she is not currently working on performance improvement. During an interview on 04/12/2022 at 9:58 AM, the interim clinical manager stated that he/she had no information on QAPI and was not working on the program. During an interview on 04/13/2022 at 2:41 PM, the administrator stated that the nurse is over all of the programs including QAPI and he/she had no further information.

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 review of the agency’s quality assessment performance (QAPI) program and interview, the agency failed to provide evidence of performance improvement activities to track adverse patient events, analyze their causes, and implement preventative actions. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Review of the QAPI program showed the agency failed to have documentation of performance improvement activities that: - Tracked adverse patient events; - Analyze their cause; and - Implement preventative actions. During an interview on 04/12/2022 at 8:35 AM, the administrator said his/her clinical manager had just resigned and a nurse that works for the agency will assume the position. The interim clinical manager has worked full time for the agency and is familiar with the QAPI program. During an interview on 04/12/2022 at 9:58 AM, the interim clinical manager stated that he/she had no information on QAPI and was not working on the program. He/she remembered monitoring performance improvement in the past but he/she is not currently working on performance improvement. During an interview on 04/13/2022 at 2:41 PM, the administrator stated that the nurse is over all of the programs including QAPI and he/she had no further information.

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 review of the agency’s quality assessment performance (QAPI) program and interview, the agency failed to provide evidence that the governing body was responsible for ensuring the agency had an ongoing program for quality improvement and patient safety. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Review of the quality assessment performance improvement (QAPI) program showed the agency failed to show documentation of the governing body involvement in ensuring an ongoing program for quality improvement and patient safety. During an interview on 04/12/2022 at 8:35 AM, the administrator said his/her clinical manager had just resigned and a nurse that works for the agency will assume the position. The interim clinical manager has worked full time for the agency and is familiar with the QAPI program. During an interview on 04/12/2022 at 9:58 AM, the interim clinical manager stated that he/she had no information on QAPI and was not working on the program. He/she remembered monitoring performance improvement in the past but he/she is not currently working on performance improvement. During an interview on 04/13/2022 at 2:41 PM, the administrator stated that there were no written governing board minutes. The nurse is over all of the programs including QAPI and he/she had no further information.

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 review of the agency’s employee files, Centers for Medicare and Medicaid (CMS) COVID-19 guidance, home visit observation, and interview, the agency failed to maintain and document a coordinated agency-wide program for surveillance, identification, prevention, control and investigation of communicable diseases. The agency failed to: - Provide infection control education to staff (G686); and - Develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19 (G687). The cumulative effect of these systemic practices resulted in the agency's inability to ensure prevention, detection, or investigation of infections that could affect all patients served by the agency. .

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 employee file review and interview, the agency failed to maintain a coordinated agency-wide infection control program that included infection control education for five (Employee #1, #2, #3, #4, and #5) of five employee files reviewed. This deficient practice has the potential to affect the health and safety of all patients served by the agency. Findings included: EMPLOYEE (E1): -Review of E1's employee file showed: - Agency employee; - Position: Interim clinical manager; - Date of hire: 02/16/2012; and - No documentation found for yearly infection control training. EMPLOYEE (E2): -Review of E2's employee file showed: - Contracted employee; - Position: Occupational therapist; - Date of hire: Not provided; and - No documentation found for yearly infection control training. EMPLOYEE (E3): -Review of E3's employee file showed: - Agency employee; - Position: Physical therapist; - Date of hire: 01/26/2011; and - No documentation found for yearly infection control training. EMPLOYEE (E4): -Review of E4's employee file showed: - Agency employee; - Position: Previous clinical manager; - Date of hire: 11/18/2019; - Last day of employment: 04/12/2022; and - No documentation found for yearly infection control training. EMPLOYEE (E5): -Review of E5's employee file showed: - Agency employee; - Position: Physical Therapist; - Date of hire: 05/04/2018; and - No documentation found for yearly infection control training. During an interview on at 04/12/2022 at 9:58 AM, the interim clinical manager stated that: - He/she has worked for the agency full time since 2012; - He/she provides in-services for medical staff; and - He/she was unsure the last time an in-service was provided on infection control.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on review of agency document and interview the agency failed to develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. This deficient practice has the potential to affect the quality of care to all patients served by the agency. Findings included: Review of the agency document, titled, “Standing Orders for Pfizer-BioNTech’s Covid-19 Vaccine Administration to Persons 12 Years of Age and Older,” dated March 30, 2022, failed to show: - Agency specific policies and procedures to ensure that all staff are fully vaccinated for COVID-19 (document is printed off of Missouri DHSS website); and - All of the required components for the policies and procedures related to Covid-19 vaccination of home health agency staff. On 04/12/2022 at 2:40 PM, the administrator provided the document to the surveyors and stated that the document was the agency’s policy and procedures for the Covid-19 vaccine of staff. During an interview on 04/13/2022 at 2:47 PM, the administrator stated that the agency verbally asked staff if they were vaccinated for covid-19 but did not obtain staff records of the vaccinations.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on clinical record review, home visit observation, and interview, the agency failed to meet the requirements for this condition of participation when the agency failed to: - Ensure development and evaluation of the plan or care in partnership with the patient, representative (if any), and caregiver(s) (G708); - Ensure patient and caregiver education (G714); - Ensure the skilled professionals assumed responsibility for preparing clinical notes (G716); and - Failed to ensure all staff, including contracted staff, received home health sponsored in-service training (G722). .

Development and evaluation of plan of care CFR(s): 484.75(b)(2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); This ELEMENT is not met as evidenced by: Based on clinical record review and interview the agency failed to ensure that skilled professional developed and evaluated the plan of care in partnership with the patient, in two (Records/Patients #3 and #5) of three discharge records reviewed. This deficient practice has the potential to affect the documentation of all of the agency patients. Findings included: RECORD/PATIENT #3: Review of the plan of care (POC) dated 03/22/2019 to 05/20/2019 showed: - Diagnoses of anterior urethral stricture (scarring that narrows the tube that carries urine out of the body), long term (current) use of anticoagulants (blood thinner), legal blindness, and history of pulmonary embolism (blood clot in lung); - Patient goals included; to be safe with ambulation, be able to care for foley and report changes, identify signs and symptoms of UTI (urinary tract infection), increase blood pressure, and maintain/improve well-being status at home; - SN foley care with monthly foley change; - Skin and pain assessment; - SN to assess vital signs with pulse ox; - SN to evaluate impaired integumentary status of surgical site as ordered until healed (no order details documented); - The POC dated 03/22/2019 to 05/20/2019, failed to show: ** Interventions for blood pressures; ** Interventions for UTI prevention and/or management; and ** Education for foley catheter care or changes to report. RECORD/PATIENT #5: Review of the plan of care, dated 06/22/2021 to 08/20/2021, showed, in part: - Diagnoses of spastic hemiplegia affecting right dominant side (part of the brain controlling movement is damaged), convulsions (uncontrollable muscle contractions), hypertension (the force of the blood against the artery walls is too high), type 2 diabetes mellitus without complications (a chronic condition that affects the way the body processes blood sugar), and apraxia (the brain is unable to make and deliver correct movement instructions to the body); - SN (skilled nurse) visit frequency1w1 (1 time weekly for 1 week) to assess and evaluate for treatment; - PT (physical therapy) visit frequency 1w1 to assess and evaluate for treatment; - Patient goals included; to be safe in home, increase strength and endurance, decrease spasticity, be ambulatory, and decrease pain; and - POC failed to include patient specific interventions and treatments to reach goals. During an interview on 04/13/2022 at 11:25 AM, the interim clinical manager agreed to the findings. No further documentation provided.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on clinical record review and interview the agency failed to ensure that skilled professional services prepared appropriate and timely clinical notes in three (Records/Patients #1, #3, and #5) of five full records reviewed. This deficient practice has the potential to affect the documentation of all of the agency patients. Findings included: RECORD/PATIENT #1: Review of the clinical record showed the following: - The comprehensive OASIS (Outcome and Assessment Information Set - a required set of assessment data submitted to Medicare and Medicaid services) assessment performed (documentation not finalized) for the start of care (SOC) on 09/26/2019 at 10:25 AM; - On 12/12/2019 (2 months and 2 weeks after start of care) at 12:28 PM, the SOC comprehensive OASIS assessment was electronically signed by a previous RN (registered nurse); - Patient had diagnosis of neuromuscular dysfunction of bladder (nerves and muscles do not work well together causing the bladder to not fill or empty properly), requiring urinary catheter (tube inserted into the bladder that allows for urine to drain); - No documentation of when catheter was last changed or due to be changed next; - The plan of care (POC) dated 09/29/2019 to 11/24/2019 was signed by urologist on 12/20/2019 (2 months and 3 weeks after POC start date) with a “urology orders only” written by the urologists under the signature; and - No documentation of when the last catheter change was or when the next catheter change is due. RECORD/PATIENT #3: Review of the clinical record showed the following: - The comprehensive OASIS assessment performed (documentation not finalized) for the start of care on 03/22/2019 at 10:15 AM; - On 06/26/2019 (3 months after SOC) at 4:08 PM, the SOC comprehensive OASIS assessment was electronically signed by a previous RN (registered nurse); - Patient had diagnosis of urethral stricture (scarring that narrows the tube that carries urine out of the body), requiring urinary catheter (tube inserted into the bladder that allows for urine to drain); - No assessment documentation for genitourinary tract for elimination status and/or catheter details; - Genitalia/Reproductive status showed “not assessed” check marked; - Oasis M1340 question regarding patient having a surgical wound has, “yes, patient showed at least one observable surgical wound” answered; - Wound assessment section showed N/A (not applicable) check marked; - No documentation of the last catheter change or when the next catheter change was due; - The plan of care (POC) dated 03/22/2019 to 05/20/2019 showed: ** Electronic signature date of 07/26/2019 (4 months after POC start date) at 2:41 PM from previous RN under the section for nurse’s signature and date of verbal order SOC; ** Diagnoses of: urethral stricture, long term (current) use of anticoagulants (blood thinner), legal blindness, and history of pulmonary embolism (blood clot in lung); ** SN (skilled nurse) urinary catheter (tube inserted into the bladder that allows for urine to drain) care with monthly catheter change; ** Skin and pain assessment; ** SN to assess vital signs with pulse ox; ** SN to evaluate impaired integumentary status of surgical site as ordered until healed (no order details documented); - The POC dated 03/22/2019 to 05/20/2019, failed to show: ** Catheter supplies; ** Detailed orders for catheter changes; and ** Surgical site details including location, assessment, and care. During an interview on 04/13/2022 at 11:25 AM, the interim CM stated: - The electronic signature date is when documentation is completed and locked; - Unsure why comprehensive SOC OASIS on 03/22/2019 at 10:15 AM was not completed until 06/26/2019 at 4:08 PM; - The patient had a suprapubic catheter placed and that may have been what the previous nurse was referring to in documentation but unaware of any other surgical procedures; and - Catheter supplies and detailed catheter change orders should be listed on POC. RECORD/PATIENT #5: Review of the plan of care, dated 06/22/2021 to 08/20/2021, showed, in part: - Diagnoses of spastic hemiplegia affecting (part of the brain controlling movement is damaged) right dominant side, convulsions (uncontrollable muscle contractions), hypertension (the force of blood against the artery walls is too high), type 2 diabetes mellitus without complications, and apraxia (brain unable to make and deliver correct movement instructions to the body); - SN visit frequency1w1 (1 time weekly for 1 week) to assess and evaluate for treatment; and - PT (physical therapy) visit frequency 1w1 to assess and evaluate for treatment. - Review of a discharge comprehensive OASIS, dated 08/13/2021, showed: ** Discharge visit date on 08/13/2021 at 4:00 PM; ** Discharge OASIS documentation completed with electronic signature on 03/15/2022 (7 months after discharge) at 4:11 PM; ** Discharge disposition (OASIS M2420) question regarding where the patient is after the discharge, answered with “Patient remained in the community without formal assistive services” (No detail on formal services); ** No discharge summary included with discharge OASIS; and ** No documentation of physician being notified and/or discharge summary being sent to physician. During an interview on 04/12/2022 at 1:05 PM, the administrator stated that he/she expects all documentation to be completed within 30 days. During an interview on 04/12/2022 at 1:15 PM, the administrator stated that he/she was not aware of the late documentation. During an interview on 04/13/2022 at 11:25 AM, the interim clinical manager stated: - Unsure why documentation was late; and - No discharge summary completed and/or sent to physician.

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 employee file review and interview, the agency failed to ensure staff were provided with agency in-service training in five (Employee #1, #2, #3, #4 and #5) of five employee files reviewed. This deficient practice has the potential to affect all agency staff. EMPLOYEE #1 (E1): Review of E1's employee file showed: - Agency staff; - Hire date: 02/16/2012; and - No documentation of any agency in-service training since 10/09/2012. EMPLOYEE #2 (E2): Review of E2's employee file showed: - Contracted staff; - Hire date: No date documented; and - No documentation of any agency in-service training. EMPLOYEE #3 (E3): Review of E3's employee file showed: - Agency staff; - Hire date: 01/26/2011; and - No documentation of any agency in-service training since 01/26/2011. EMPLOYEE #4 (E4): Review of E4's employee file showed: - Agency staff; - Hire date: 11/18/2019; and - No documentation of any agency in-service training since 11/18/2019. During EMPLOYEE #5 (E5): Review of E5's employee file showed: - Agency staff; - Hire date: 02/16/2012; and - No documentation of any agency in-service training since 02/16/2012. Reviewed the above finding on 04/12/2022 at 9:58 AM, with the interim clinical manager and no further information was provided. During an interview on 04/13/2022 at 2:41 PM, the administrator stated that he/she had reviewed the employee files and there was no other documentation

Org. had partial/extended survey CFR(s): 484.80(f)(3) Was subjected to an extended (or partially extended) survey as a result of having been found to have furnished substandard care (or for other reasons as determined by CMS or the state); or This ELEMENT is not met as evidenced by: Based on the results of the extended level survey, the agency was found out of compliance in twelve Conditions of Participation: Reporting OASIS information, patient rights, comprehensive assessment of patients, discharge planning, care planning, coordination of services and quality of care, quality assessment and performance improvement (QAPI), infection prevention and control, skilled professional services, emergency preparedness, organization and administration of services, clinical records, and personnel qualifications. The agency may not train or competency evaluate their home health aides for a period of two (2) years following the date of this survey. The restriction ends 04/14/2024. .

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 observation, and interviews, the agency failed to organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care when the agency failed to ensure a governing body, administrative, and clinical manager oversight to patients resulting in twelve conditions of participation citations. The following deficiencies were cited under this condition of participation: - The governing body assumed full legal authority and responsibility for the agency management, operation, and the provision of all home health services including its quality assessment performance improvement (QAPI) program (G942); - Ensure the administrator was appointed by and reported directly to the governing body (G946); - The administrator ensured that the agency employs qualified personnel including assuring the development of personnel qualifications and policies (G952); and - When the administrator is not available, a qualified, predesignated person, who is authorized in writing by the administrator and governing body, assumes the same responsibilities and obligations as the administrator (G954). The cumulative effect of these systemic practices resulted in the agency's inability to ensure the patient's care needs would be met. .

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 requested document review, and interview, the agency failed to demonstrate and ensure the governing body had assumed effective oversight responsibility for the operation of the agency. The deficient practice has the potential to affect all patients served by the home health agency. Findings included: The agency failed to show evidence/documentation of the governing body involvement in ensuring an ongoing program for quality improvement and patient safety. During an interview on at 04/13/2022 at 2:41 PM and 04/14/2022 at 9:15 AM, the administrator stated that: - There was no documentation to show governing body activity; and - He/she was unable to find requested policies and procedure of the governing body.

Administrator appointed by governing body CFR(s): 484.105(b)(1)(i) (i) Be appointed by and report to the governing body; This ELEMENT is not met as evidenced by: Based on requested document review, and interview, the agency failed to ensure an administrator was appointed by and reported directly to the governing body. This deficient practice has the potential to affect the health and safety of all the patients served by the agency. Findings included: During an interview on 04/12/2022 at 1:05 PM, the administrator stated that there was no official governing body meetings or minutes because “we are the governing body.” He/she did not provide any further information.

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on employee file review and interview, the administrator failed to ensure the agency developed personnel policies and provided adequate in-service training to five staff (Employees E1, E2, E3, E4 and E5) of five employee files reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of employee files showed the administrator failed to ensure adequate staff orientation/training when the following occurred: - Employee E1 was an interim clinical manager hired by the agency on 02/16/2012, and the personnel file failed to show documented evidence of annual infection control education and emergency preparedness training provided to the employee; - Employee E2 was a contracted occupational therapist hired by the contract agency (no date of hire documented), and the personnel file failed to show documented evidence of infection control education, annual agency in-service training, Alzheimer training and emergency preparedness training provided to the employee; - Employee E3 was a physical therapist hired by the agency on 01/26/2011, and the personnel file failed to show documented evidence of the required home health agency annual in-service training, annual infection control training, and emergency preparedness training provided to the employee; - Employee E4 was a previous clinical manager hired by the agency on 11/18/2019, and the personnel file failed to show documented evidence of the required home health agency annual in-service training, annual infection control training, and emergency preparedness training provided to the employee; and - Employee E5 was an administrator hired by the agency on 05/04/2018, and the personnel file failed to show documented evidence of the required home health agency annual in-service training, annual infection control training, and emergency preparedness training provided to the employee. During an interview on 04/12/2022 at 9:58 AM, the interim clinical manager stated that: - He/she has worked for the agency full time since 2012; - He/she provides in-services for medical staff; and - He/she was unsure the last time an in-service was provided on emergency preparedness and infection control.

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 interview, the agency failed to ensure 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 when the administrator is not available. This deficient practice has the potential to affect the health and safety of all the patients served by the agency. Findings included: During an interview on 04/13/2022 at 9:50 AM, the interim clinical manager stated that he/she was not the administrator designee. He/she just accepted the clinical manager position and told the agency he/she was going to help them out until they hired a clinical manager. He/she considered short term to be less than 30 days. During an interview on 04/13/2022 at 2:41 PM, the administrator stated that the interim clinical manager was the interim administrator designee. There was no information, in writing, to show the pre-designated administrator. The agency failed to provide documentation from the governing body regarding the appointment of the pre-designated, qualified person to act in the absence of the administrator.

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on clinical record review, and interview, the agency failed to: - Ensure a complete 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 home health agency within 5 business days of the patient's discharge (G1022); - Ensure all entries were legible, clear, complete, and appropriately authenticated, dated, and timed (G1024); and - Ensure clinical record information was safeguarded against loss or unauthorized use (G1028). The cumulative effects of these deficient practices has the potential to effect all patients served by the home health agency. .

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 completed discharge summary was 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 in three (Records/Patients #3, #4, and #5) of three discharge records reviewed. This deficient practice has the potential to affect all discharged or transferred patients served by the agency. Findings included: RECORD/PATIENT #3: Review of a discharge comprehensive OASIS (Outcome and Assessment Information Set - a required set of assessment data submitted to Medicare or Medicaid Services) dated 11/05/2021, showed: - Discharge visit date on 11/05/2021 at 4:00 PM; - Discharge OASIS documentation completed with electronic signature on 03/15/2022 (4 months after discharge) at 3:56 PM; - No discharge summary included with discharge OASIS; and - No documentation of physician being notified and/or discharge summary being sent to physician. During an interview on 04/13/2022 at 11:25 AM, the interim clinical manager stated: - OASIS documentation completed on 03/15/2022 for the discharge visit on 11/05/2021 because the discharge was backdated to the last date of the episode in which the agency had signed orders for; - Visits made after 11/05/2021 were not billed for since the physician would not sign the orders; and - No discharge summary completed and/or sent to physician. RECORD/PATIENT #4: Review of a discharge comprehensive OASIS, dated 11/26/2021, showed: - Discharge visit date on 11/26/2021 at 12:00 PM; - Discharge OASIS documentation completed with electronic signature on 12/05/2021 at 12:45 PM; - No discharge summary included with discharge OASIS; and - No documentation of physician being notified and/or discharge summary being sent to physician. RECORD/PATIENT #5: Review of a discharge comprehensive OASIS, dated 08/13/2021, showed: - Discharge visit date on 08/13/2021 at 4:00 PM; - Discharge OASIS documentation completed with electronic signature on 03/15/2022 (7 months after discharge) at 4:11 PM; - No discharge summary included with discharge OASIS; and - No documentation of physician being notified and/or discharge summary being sent to physician. During an interview on 04/13/2022 at 11:25 AM, the interim clinical manager stated: - Unsure why OASIS documentation was not completed until 03/15/2022 when patient was discharged on 08/13/2021; and - No discharge summary completed and/or sent to physician’s for any of the patient’s discharged.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure all documented entries included appropriate authentication that included, the time the plans of care were completed, the plan of care signed by the nurse, plans of care dated by the physician, and time the visits were completed in, but not limited to, two (Records/Patients #3 and #5) of three discharge records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: RECORD/PATIENT #3: Review of the clinical record showed: - The SN (skilled nurse) SOC (start of care) visit was dated, 03/22/2019 at 10:15 AM; - On 06/26/2019 at 4:08 PM, the SOC comprehensive OASIS assessment was electronically signed (3 months after SOC visit) by previous CM (Clinical Manager); - The plan of care (POC) dated 03/22/2019 to 05/20/2019 showed: ** SN electronic signature date of 07/26/2019 (4 months after POC start date) at 2:41 PM; ** Physician signed POC orders on 10/08/2019; - Discharge visit date on 11/05/2021 at 4:00 PM; and - Discharge Oasis documentation not completed and signed until 03/15/2022 at 3:56 PM; RECORD/PATIENT #5: Review of the clinical record showed: - The comprehensive OASIS assessment performed (documentation not finalized) for the start of care on 06/22/2021 at 11:00 AM; - On 07/03/2021 at 2:10 PM, the SOC comprehensive OASIS assessment was electronically signed by a previous RN (registered nurse); - The plan of care (POC) dated 06/22/2021 to 08/20/2021 showed: ** Electronic signature date of 07/22/2021 at 3:24 PM from previous RN under the section for nurse’s signature and date of verbal order SOC; ** Physician never signed the POC; - Discharge visit date on 08/13/2021 at 4:00 PM; and - Discharge Oasis documentation completed with electronic signature on 03/15/2022 at 4:11 PM. During an interview on 04/12/2022 at 9:58 AM, the interim clinical manager stated: -He/she would complete the OASIS but something would “screw up” if he/she submitted the OASIS; and - The previous CM would lock them and submit them but was not the one that made the visit. During an interview on 04/13/2022 at 11:25 AM, the interim clinical manager (CM) stated: - The electronic signature date is when documentation is completed and locked; - The CM is the only one that can complete and lock the electronic records; - The CM electronically signs all electronic records for visits even if the CM is not the nurse that did the visit; - The name of the SN (skilled nurse) that completed the visits does not show up on the electronic record; and - There is no way to know who the SN was that actually completed the visit.

Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This STANDARD is not met as evidenced by: Based on agency observation and interview the agency failed to ensure that clinical record information was safeguarded against loss or unauthorized use. Findings included: During agency observation on 04/12/2022, showed: - Agency staff retrieving clinical records from a closet on the second floor of the agency; - Paper copies of clinical records kept in large envelops with the patient’s name written on the front of envelop; - Closet door was not locked; and - Clinical records not safeguarded against loss or unauthorized use. During an interview on 04/12/2022 at 9:58 AM, the interim clinical manager (CM) acknowledged the findings and agreed that clinical records were not safeguarded against loss or unauthorized use.

Personnel qualifications CFR(s): 484.115 Condition of participation: Personnel qualifications. HHA staff are required to meet the following standards: This CONDITION is not met as evidenced by: Based on employee file review and interview, the agency failed to ensure HHA (home health agency) staff meet the required following standards: - The Administrator: (i) Is a licensed physician, a registered nurse, or holds an undergraduate degree; (ii) Has experience in health service administration, with at least 1 year of supervisory or administrative experience in home health care or a related health care program (G1052); and - Physical Therapist, is a person who is licensed, if applicable, by the state in which practicing (G1066). The cumulative effect of these deficient practices resulted in the agency's inability to ensure that all HHA staff meet the required standards for personnel qualifications. This deficient practice has the potential to affect the quality of care to all patients served by the agency. .

Administrator CFR(s): 484.115(a) Standard: Administrator, home health agency. (1) For individuals that began employment with the HHA prior to January 13, 2018, a person who: (i) Is a licensed physician; (ii) Is a registered nurse; or (iii) Has training and experience in health service administration and at least 1 year of supervisory administrative experience in home health care or a related health care program. (2) For individuals that begin employment with an HHA on or after January 13, 2018, a person who: (i) Is a licensed physician, a registered nurse, or holds an undergraduate degree; and (ii) Has experience in health service administration, with at least 1 year of supervisory or administrative experience in home health care or a related health care program. This STANDARD is not met as evidenced by: Based on employee file review and interview, the agency failed to show the HHA (home health agency) administrator meets the required following standards: - Is a licensed physician, a registered nurse, or holds an undergraduate degree; and - Has experience in health service administration, with at least 1 year of supervisory or administrative experience in home health care or a related health care program. This deficient practice has the potential to affect the quality of care to all patients served by the agency. Findings included: Review of the administrator employee file, showed: - Date of hire on 05/14/2018; - Employment application has previous education listed at [Named] college, from 1991-1994, in theological studies; - Employment application has degree listed as having BS (Bachelors) in telecommunications; - Previous employment history included: ** 12/15/1998 to 12/15/2005 worked as a manager for a newspaper [Named] company with “numerous” listed for job duties; ** 01/01/2006 to Current as Lead Pastor at [Named] church; - Employee file failed to show college diploma with undergraduate degree; and - Employee file failed to show experience in health service administration, with at least 1 year of supervisory or administrative experience in home health care or a related health care program. On 04/13/2022 at 2:40 PM, the administrator stated: - Has previous experience as a manager of marketing in healthcare services but did not list it on the application; - Has a copy of degree but not in employee file; and - Will provide a copy of degree to the surveyors tomorrow (04/14/2022). On 04/14/2022 at 9:15 AM, when asked about copy of degree, the administrator stated that he/she did not have a copy of degree to provide to surveyors. No further documentation provided.

Physical Therapist CFR(s): 484.115(h) Standard: Physical therapist. A person who is licensed, if applicable, by the state in which practicing, unless licensure does not apply and meets one of the following requirements: (1)(i) Graduated after successful completion of a physical therapist education program approved by one of the following: (A) The Commission on Accreditation in Physical Therapy Education (CAPTE). (B) Successor organizations of CAPTE. (C) An education program outside the United States determined to be substantially equivalent to physical therapist entry level education in the United States by a credentials evaluation organization approved by the American Physical Therapy Association or an organization identified in 8 CFR 212.15(e) as it relates to physical therapists. (ii) Passed an examination for physical therapists approved by the state in which physical therapy services are provided. (2) On or before December 31, 2009- (i) Graduated after successful completion of a physical therapy curriculum approved by the Commission on Accreditation in Physical Therapy Education (CAPTE); or (ii) Meets both of the following: (A) Graduated after successful completion of an education program determined to be substantially equivalent to physical therapist entry level education in the United States by a credentials evaluation organization approved by the American Physical Therapy Association or identified in 8 CFR 212.15(e) as it relates to physical therapists. (B) Passed an examination for physical therapists approved by the state in which physical therapy services are provided. (3) Before January 1, 2008 graduated from a physical therapy curriculum approved by one of the following: (i) The American Physical Therapy Association. (ii) The Committee on Allied Health Education and Accreditation of the American Medical Association. (iii) The Council on Medical Education of the American Medical Association and the American Physical Therapy Association. (4) On or before December 31, 1977 was licensed or qualified as a physical therapist and meets both of the following: (i) Has 2 years of appropriate experience as a physical therapist. (ii) Has achieved a satisfactory grade on a proficiency examination conducted, approved, or sponsored by the U.S. Public Health Service. (5) Before January 1, 1966- (i) Was admitted to membership by the American Physical Therapy Association; (ii) Was admitted to registration by the American Registry of Physical Therapists;or (iii) Graduated from a physical therapy curriculum in a 4-year college or university approved by a state department of education. (6) Before January 1, 1966 was licensed or registered, and before January 1, 1970, had 15 years of fulltime experience in the treatment of illness or injury through the practice of physical therapy in which services were rendered under the order and direction of attending and referring doctors of medicine or osteopathy. (7) If trained outside the United States before January 1, 2008, meets the following requirements: (i) Was graduated since 1928 from a physical therapy curriculum approved in the country in which the curriculum was located and in which there is a member organization of the World Confederation for Physical Therapy. (ii) Meets the requirements for membership in a member organization of the World Confederation for Physical Therapy. This STANDARD is not met as evidenced by: Based on employee file review and interview, the agency failed to show the Physical Therapist had an updated, current license, by the state in which the Physical Therapist is practicing. This deficient practice has the potential to affect the quality of care to all patients served by the agency. Findings included: Review of the Physical Therapist employee file, showed: - Date of hire on 01/26/2011; and - Most recent license in employee file expired on 01/31/2020. During review of the employee files, on 04/13/2022 at 2:40 PM, the interim Clinical Manager stated: - All records for employees would be in their file; - “I’m sure [Physical Therapist] has a copy of [his/her] current license and it is just not updated in [his/her] employee file; and - “I will contact [Physical Therapist] for a copy of [his/her] current license. On 04/13/2022 at 3:00 PM, the administrator was provided a list of items still needed by surveyors and updated license for PT was requested. 04/14/2022 at 9:18 AM, the administrator stated, no further documentation available to provide to surveyors.