Every finding on record at Loretta's Home Health Care, Inc.

The Oklahoma State Department of Health conducted an unannounced Medicare Emergency Preparedness Program survey at the agency on 10/18/22 to 10/19/22. Standard deficiencies were cited as a result of the Emergency Preparedness Program survey.

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 record review and interview, the agency failed to develop and implement an agency emergency preparedness program for all patients and employees. Finding: A review of administrative records showed no emergency preparedness program was in place at the agency. On 10/19/22 at 3:00 p.m., Staff B stated the agency had no emergency preparedness program in place.

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure a community-based risk assessment (All Hazards Risk Assessment) that identified the agency and included a date the assessment was developed, implemented and/or reviewed and in place for all patients and employees. Findings: A review of administrative records showed no community-based risk assessment developed, implemented and/or reviewed for the agency, its patient population, or its employees. On 10/19/22 at 3:00 p.m., Staff B stated no AHRA was developed, implemented or was reviewed for the agency, patients and employees.

Local, State, Tribal Collaboration Process CFR(s): 484.102(a)(4) §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility's needs in the event of an emergency. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure development, implementation and maintenance of processes for an integrated emergency preparedness response with Federal, State, Tribal, Regional and Local emergency management officials for all patients and employees. Findings: A review of administrative records showed no administrative processes for an integrated emergency preparedness response with Federal, State, Tribal, Regional and Local emergency management officials for the agency were in place. On 10/19/22 at 3:00 p.m., Staff B stated the agency did not have an Emergency Preparedness Plan nor administrative processes for an integrated emergency preparedness response in place.

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 record review and interview, the agency failed to ensure administrative policies and procedures related to an Emergency Preparedness Plan were in place for all patients and employees. Findings: A review of administrative records showed no administrative policies and procedures related to an Emergency Preparedness Plan for the agency. On 10/19/22 at 3:00 p.m., Staff B stated the agency did not have an Emergency Preparedness Plan with administrative policies and procedures in place.

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 record review and interview, the agency failed to ensure development of an Emergency Preparedness Communication Plan which included required information related to all patients, employees and resources of the agency affecting all patients and employees. Findings: A review of administrative records showed no Emergency Preparedness Communication Plan for the agency. On 10/19/22 at 3:00 p.m., Staff B stated the agency did not have an Emergency Preparedness Communication Plan in place.

Emergency Officials Contact Information CFR(s): 484.102(c)(2) §403.748(c)(2), §416.54(c)(2), §418.113(c)(2), §441.184(c)(2), §460.84(c)(2), §482.15(c)(2), §483.73(c)(2), §483.475(c)(2), §484.102(c)(2), §485.68(c)(2), §485.625(c)(2), §485.727(c)(2), §485.920(c)(2), §486.360(c)(2), §491.12(c)(2), §494.62(c)(2). [(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: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure an Emergency Preparedness Communication Plan included required contact information for Federal, State, Tribal, Regional and Local emergency management agencies for the agency, all patients and employees. Findings: A review of administrative records showed no documentation the Emergency Preparedness Communication Plan included contact information for Federal, State, Tribal, Regional and Local emergency management resource agencies for the agency. On 10/19/22 at 3:00 p.m., Staff B stated they had no Emergency Preparedness Communication Plan that included required contact information for Federal, State, Tribal, Regional and Local emergency management resource agencies for the agency.

EP Training and Testing CFR(s): 484.102(d) §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.625(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 record review and interview, the agency failed to ensure: 1. An emergency preparedness testing and training program was developed, implemented and reviewed/updated for all patients and employees and; 2. An after-action report was documented after each drill, exercise or plan activation event for all patients and employees. Findings: A review of administrative records showed no emergency preparedness plan testing and training program was developed, implemented and reviewed. On 10/19/22 at 3:00 pm, Staff B stated the agency had no emergency preparedness plan testing and training program.

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 record review and interview, the agency failed to ensure emergency preparedness disaster table-top exercises, drills, community drills or plan activation events were conducted for calendar years 2020, 2021 and for 01/01/22 to 10/19/22 for all patients and employees. Findings: A review of administrative records showed no emergency preparedness disaster table-top exercises, drills, community drills or plan activation events for calendar years 2020, 2021 and 01/01/22 to 10/19/22. On 10/19/22 at 3:00 pm, Staff B stated the agency had no emergency preparedness disaster table-top exercises, drills, community drills or plan activation events for calendar years 2020, 2021 and 01/01/22 to 10/19/22.

The Oklahoma State Department of Health conducted an unannounced Medicare re-certification survey at the agency on 10/18/22 to 10/19/22. An entrance conference was conducted with Staff A. The survey process was explained. Questions were answered. Staff A and B were identified as the contact persons for administrative issues and Staff E was identified as the contact person for clinical issues. Findings were discussed during an informal exit conference with Staff A and B. Condition level deficiencies were cited in the following areas: 484.60 Quality Assessment and Performance Improvement 484.75 Infection Control 454.105 Organization and administration of services Glossary: eMR electronic medical record POC plan of care QAPI Quality Assessment and Performance Improvement RN Registered Nurse ROC resumption of care SN skilled nurse

Written notice of patient's rights CFR(s): 484.50(a)(1)(i) (i) Written notice of the patient's rights and responsibilities under this rule, and the HHA's transfer and discharge policies as set forth in paragraph (d) of this section. Written notice must be understandable to persons who have limited English proficiency and accessible to individuals with disabilities; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure patients received a statement of rights at the time of admission to the agency for care and services for seven patients (Patients #1-7). On 10/18/22 at 10:15 a.m., Patient admission packet information that contained forms for Patient Rights and introduction to the agency were requested during the entrance conference of the survey. No information or copy of the requested forms were provided. At 11:00 a.m., Staff A stated the agency had no agency admission packet of information and patients signed for information electronically in their eMR upon admission to the agency. From 11:00 a.m. to 2:30 p.m., eMR clinical patient record reviews were completed for patients #1, 2, 3, 4 and #5. No electronic receipt of Patient Rights or paper forms were documented in the eMR’s patient information/authorization, electronic medical record or orders and documents section tabs of the records. On 10/19/22 at 10:05 a.m., a second request for patient admission packet information with patient forms were requested. No information or copy of the requested forms were provided. A review of the eMR clinical patient record review showed no electronic receipt of Patient Rights or paper forms documented in the eMR’s patient information/authorization, electronic medical record or orders and documents section tabs of the records. At 11:30 a.m., Staff C stated all patient documentation including scanned attachments were located in the patients eMR’s patient information/authorization, electronic medical record or orders and documents section tabs of the records for patients #1, 2, 3, 4, 5, 6 and #7 and any forms or attachments including electronic receipt of Patient Rights or paper form documents were located in those sections of the patient records. Staff C was advised there was no documentation. No additional response was 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 record review and interview, the agency failed to ensure patients received informed consent at the time of admission to the agency for care and services for seven of seven patients (Patients #1-7). On 10/18/22 at 10:15 a.m., Patient admission packet information that contained forms for consent and introduction to the agency were requested during the entrance conference of the survey. No information or copy of the requested forms were provided. At 11:00 a.m., Staff A stated the agency had no agency admission packet of information and patients signed for consent and information electronically in their eMR upon admission to the agency. A review of clinical records showed no electronic consent or paper forms documented in the eMR’s patient information/authorization, electronic medical record or orders and documents section tabs of the records. On 10/19/22 at 10:05 a.m., a second request for patient admission packet information with patient forms were requested. No information or copy of the requested forms were provided. At 11:30 a.m., Staff C stated all patient documentation including scanned attachments were located in the patients eMR’s patient information/authorization, electronic medical record or orders and documents section tabs of the records for patients #1, 2, 3, 4, 5, 6 and #7 and any forms or attachments including electronic consent or paper forms and documents were located in those sections of the patient records. No additional response was received regarding the request for additional information or the lack of requested documentation.

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 record review and interview, the agency failed to ensure patients received a statement of billing and complaint processes at the time of admission to the agency for care and services for seven patients. On 10/18/22 at 10:15 a.m., Patient admission packet information that contained forms for billing, complaints and introduction to the agency were requested during the entrance conference of the survey. No information or copy of the requested forms were provided. At 11:00 a.m., Staff A stated the agency had no agency admission packet of information and patients signed for information electronically in their eMR upon admission to the agency. A review of clinical records showed no electronic receipt or paper forms related to billing, complaints and introduction to the agency documented in the eMR’s patient information/authorization, electronic medical record or orders and documents section tabs of the records. On 10/19/22 at 10:05 a.m., a second request for patient admission packet information with patient forms were requested. No information or copy of the requested forms were provided.

State toll free HH telephone hotline CFR(s): 484.50(c)(9) Be advised of the state toll free home health telephone hot line, its contact information, its hours of operation, and that its purpose is to receive complaints or questions about local HHAs. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure patients received a statement of the grievance processes and OSDH complaint hotline information at the time of admission to the agency for care and services for seven patients. On 10/18/22 at 10:15 a.m., Patient admission packet information that contained forms for grievance processes for the agency and OSDH contact information were requested during the entrance conference of the survey. No information or copy of the requested forms were provided. At 11:00 a.m., Staff A stated the requested information was in the eMR. A review of the clinical and administrative records showed no electronic receipt, no paper forms related to grievance processes for the agency and OSDH contact information . At 11:30 a.m., Staff C stated all patient documentation for Patients #1, 2, 3, 4, 5, 6 and #7 including electronic consent or receipt of grievance processes forms and OSDH contact information documents were located in those tabular sections of the patient records. No additional response was given by Staff C when informed the clinical records lacked the requested documentation.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure a medication profile was reviewed and updated with changes in medications for two (Patients #3 and #5) of seven patients. Findings: Patient #3 A review of a POC dated 09/04/22 to 11/02/22 showed an order for Ezetimibe (a statin) 10 milligrams at bedtime. Documentation of a SN note dated 09/29/22 showed the patient reported the medication had been discontinued. Documentation showed no follow up with the physician to confirm the medication had been discontinued and no update to the medication profile. Patient #5 A review of a POC dated 08/10/22 to 10/08/22 showed an order for Lantus (a type of insulin) 15 units daily. Documentation showed post in-patient hospital orders dated 09/14/22 for Lantus 35 units twice daily. Documentation showed no follow up with the physician and no update to the medication profile. On 10/19/22 at 12:00 p.m., Staff E stated the medication profiles for patients #3 and #5 should have been reviewed and updated to reflect changes in the ordered medications.

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 completion of a transfer/discharge summary for two (Patients #6 and #7) of seven patients. Findings: Patient #6 A review of the clinical record showed the patient was transferred/discharged from the agency on 05/25/22 to in-patient hospital services. Documentation showed no transfer/discharge summary and no summary of care was completed. Patient #7 A review of the clinical record showed the patient was transferred/discharged from the agency on 09/09/22 to in-patient hospital services. Documentation showed no transfer/discharge summary and no summary of care was completed. On 10/19/22 at 11:30 a.m., Staff C stated the agency did not complete a transfer/discharge summary or summary of care for patients #6 and #7.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record reviews and interview, the agency failed to ensure: 1. Physician orders for physical therapy visits for one (Patient #3) of seven patients; 2. Physician ordered wound care for one (Patient #5) of seven patients; 3. Physician orders for SN to administer insulin medications for one (Patient #5) of seven patients and; 4. Physician POC orders after SN ROC assessment was conducted for one (Patient #5) of seven patients. Findings: Patient #3 A review of the plan of care dated 09/04/22 to 11/02/22 showed no orders for physical therapy services. Documentation showed PT visits conducted on 09/06/22, 09/08/22, 09/20/22, 09/27/22, 09/30/22, 10/04/22 and on 10/07/22. Documentation showed no physician notification for PT services and no change in orders. Patient #5 A review of the plan of care dated 08/10/22 to 10/08/22 showed a SN visit frequency of two times a week for eight weeks. Documentation showed no orders for SN to perform wound care to the right ankle or administer insulin medications. Documentation showed SN visits conducted on 08/14/22, 08/16/22, 08/21/22, 08/23/22, 08/28/22, 09/01/22, 09/06/22 and on 09/11/22. Documentation showed wound care performed every visit included the use of normal saline, calcium alginate dressing material and covered with abdominal (ABD) and kerlex dressing materials (not ordered by the physician). Documentation showed no physician notification of the wound care and use of the dressing materials and no change in orders. During SN visits conducted on 08/14/22, blood sugar level of 487 and on 09/01/22, blood sugar level of 400; documentation showed the SN administered insulin medications for elevated blood sugar levels. Documentation showed no physician notification of the blood sugar levels and no change in orders. Documentation showed the patient was admitted to in-patient hospital services on 09/11/22 and resumed agency services on 09/15/22. Documentation showed no ROC orders from the physician for SN visits frequency or for SN to perform wound care to the right ankle. Documentation showed SN visits were conducted on 09/18/22, 09/20/22, 09/23/22, 09/28/22, 09/30/22, 10/03/22 and on 10/07/22. Documentation showed wound care performed every visit included the use of normal saline, calcium alginate dressing material and covered with abdominal (ABD) and kerlex dressing materials (not ordered by the physician). Documentation showed no physician notification of the SN visit frequency, wound care or use of the dressing materials and no change in orders. On 10/19/22 at 11:50 a.m., Staff E stated: 1. Physical therapy orders for patient #3 should have been obtained and documented prior to the therapy visits; 2. Wound care orders for patient #5 should have been obtained from the physician and documented prior to SN visits for wound care; 3. SN should have obtained and documented physician orders to administer insulin medications for patient #5 and; 4. Physician orders after the ROC assessment was conducted should have been obtained and documented for patient #5 prior to SN visits.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure evidence of a patient centered QAPI Program for all patients and employees. The failed practice had the potential to place all patients and employees at risk for insufficient efforts to improve care, services and operations. See tag G642. Based on record review and interview, the agency failed to ensure utilization of QAPI data to improve program effectiveness, quality of patient care and overall program improvement for all patients and employees. The failed practice had the potential to place all patients at risk of repeated agency mishaps, ineffective management of care and poor quality of care. See tag G644. Based on record review and interview, the agency failed to ensure conduction of patient centered QAPI Program activities for all patients and employees. The failed practice had the potential to place all patients and employees at risk for insufficient self-monitoring. See tag G646. Based on record review and interview, the agency failed to ensure governing body oversite of the conduction of a patient centered QAPI Program activities for all patients and employees. The failed practice had the potential to place all patients and employees at risk for insufficient governing body oversite of agency services and operations. See tag G660.

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure evidence of a patient centered QAPI Program for all patients and employees. The failed practice had the potential to place all patients and employees at risk for insufficient efforts to improve care, services and operations. Findings: A review of administrative records showed no ongoing patient centered QAPI program and no QAPI data collected, monitored or evaluated by the agency for calendar year 2021; and no QAPI data monitored or evaluated by the agency for 01/01/22 through 07/28/22. On 10/19/22 at 2:45 p.m., Staff A stated there was no agency participation in an ongoing QAPI program for calendar year 2021 and 01/01/22 through 07/28/22.

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure utilization of QAPI data to improve program effectiveness, quality of patient care and overall program improvement for all patients and employees. The failed practice had the potential to place all patients at risk of repeated agency mishaps, ineffective management of care and poor quality of care. Findings: A review of administrative records showed no data collection activities utilized in the agency's QAPI Program for calendar year 2021 and 01/01/22 through 10/19/22. On 10/19/22 at 2:45 p.m., Staff A stated: 1. The agency had no program improvement data available for calendar year 2021 and 01/01/22 through 10/19/22 and; 2. No analysis of collected data that showed improved quality of patient care for calendar year 2021 and 01/01/22 through 10/19/22.

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 record review and interview, the agency failed to ensure conduction of patient centered QAPI Program activities for all patients and employees. The failed practice had the potential to place all patients and employees at risk for insufficient self-monitoring. Findings: A review of administrative records showed no conduction of QAPI program activities to improve the care, services, and operations of the agency for calendar year 2021 and 01/01/22 through 10/19/22. On 10/19/22 at 2:45 p.m., Staff A stated the agency had no conduction of patient centered QAPI Program activities for calendar year 2021 and 01/01/22 through 10/19/22.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure governing body oversite of the conduction of a patient centered QAPI Program activities for all patients and employees. The failed practice had the potential to place all patients and employees at risk for insufficient governing body oversite of agency services and operations. Findings: A review of administrative records showed no governing body oversite of ongoing QAPI program activities to improve the care, services, and operations of the agency for calendar year 2021, and 01/01/22 through 07/27/22. On 10/19/22 at 2:45 p.m., Staff A stated the agency had no documentation which showed governing body oversite of ongoing QAPI program activities for calendar year 2021, and 01/01/22 through 07/28/22.

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

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure its infection control program was included in QAPI program activities for all patients and staff. This failed practiced placed the agency at risk for missed opportunities to identify and correct substandard practices and reduced opportunities to create learning throughout the agency for all patients and employees. Findings: A review of administrative records showed no agency infection control program and no infection control surveillance data was included in QAPI program activities for calendar year 2021 and 01/01/22 to 10/19/22. On 10/19/22 at 2:00 p.m., Staff C stated infection control program activities and its surveillance data were not reported through the agency's QAPI program for calendar year 2021 and 01/01/22 to 10/19/22.

Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure infection control education was: 1. Included in QAPI activities; 2. Showed interventions to reduce future infections; and 3. Provided and/or maintained for all patients and employees. This failed practice placed all patients and employees at risk for infectious disease transmission and lost opportunity for infectious disease prevention. Findings: A review of administrative records showed no documentation of infection control program education or learning activities provided by the agency for calendar year 2020 and 01/01/22 through 10/19/22. On 10/19/22 at 2:00 p.m., Staff C stated there was no documentation of infection control program education or learning activities provided by the agency for calendar year 2021 and 01/01/22 through 10/19/22.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure services were provided as ordered on the POC’s for: 1. SN to conduct assessment of patient blood pressure every visit and notify the physician of levels outside of reporting parameters for one (Patient #1) of seven patients; 2. SN to conduct assessment of patient weight every visit and notify the physician of change in patient weight for two (Patients #2 and 3) of seven patients and 3. SN visits were conducted as ordered for three (Patients #5, 6 and #7) of seven patients. Findings: Patient #1 A review of the POC dated 08/10/22 to 10/08/22 showed orders for SN to conduct assessment of patient blood pressure every visit and notify the physician of levels outside of reporting parameter of 180/90. Clinical documentation showed during a SN visit conducted on 08/24/22 the patient’s blood pressure was 175/105. Documentation showed no physician notification of the blood pressure and no change in orders. Patient #2 A review of the POC dated 08/18/22 to 10/16/22 showed orders for SN to conduct assessment of patient weight every visit and notify the physician of change in patient weight of three pounds in day or five pounds in a week. A review of clinical documentation showed no patient weight assessment conducted during SN visits on 08/22/22, 08/29/22, 09/06/22 and on 10/03/22. Documentation showed no patient/caregiver refusal of patient weight assessment, no physician notification of the weight loss and no change in orders. Patient #3 A review of the POC dated 09/04/22 to 11/02/22 showed orders for SN to conduct assessment of patient weight every visit and notify the physician of change in patient weight of one to two pounds in twenty four hours or five pounds in five days. A review of clinical documentation showed no patient weight assessment was conducted during SN visits on 09/12/22, 09/29/22, 10/06/22 and on 10/13/22. Documentation showed no patient/caregiver refusal of patient weight assessment, no physician notification of the weight loss and no change in orders. Patient #5 A review of the POC dated 08/10/22 to 10/08/22 showed a SN frequency of two times a week for eight weeks. A review of clinical documentation showed SN visits during the week of 09/04/22 to 09/10/22 on 09/06/22 (two visits ordered, one visit missed). Documentation showed no patient/caregiver refusal of visit, no physician notification of missed visit attempt and no change in orders. Patient #6 A review of the POC dated 03/29/22 to 05/27/22 showed a SN frequency of two times a week for one week, then three times a week for eight weeks. A review of clinical ocumentation showed SN visits during the week of 04/17/22 to 04/23/22 on 04/18/22 and 04/21/22 (three visits ordered, one visit missed), 04/24/22 to 04/30/22 on 04/25/22 and 04/28/22 (three visits ordered, one visit missed), 05/01/22 to 05/07/22 on 05/01/22 and 05/03/22 (three visits ordered, one visit missed), 05/08/22 to 05/14/22 on 05/08/22 and 05/10/22 (three visits ordered, one visit missed), 05/15/22 to 05/21/22 on 05/15/22 (three visits ordered, two visit missed) and 05/22/22 to 05/25/22 (three visits ordered, three visit missed). Documentation showed no patient/caregiver refusal of visit, no physician notification of missed visit attempts and no change in orders. Patient #7 A review of the POC dated 07/15/22 to 09/09/22 showed a SN frequency of one times a week for nine weeks. A review of clinical documentation showed SN visits during the week of 08/21/22 to 08/27/22 (one visits ordered, one visit missed), 08/28/22 to 09/03/22 (one visits ordered, one visit missed), 09/04/22 to 09/06/22 (one visits ordered, one visit missed). Documentation showed no patient/caregiver refusal of visit, no physician notification of missed visit attempt and no change in orders. On 10/19/22 at 12:30 p.m., Staff E stated: SN was supposed to conduct assesment of patient blood pressure every visit and notify the physician of levels outside of reporting parameters for patient #1; SN was supposed to conduct assessment of patient weight every visit and notify the physician of change in patient weight for patients #2 and 3 and; SN was supposed to conduct visits as ordered for patients #5, 6 and #7.

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on record review and interview the agency failed to ensure governing body oversite of: 1. A patient centered QAPI program for calendar year 2021 and 01/01/22 through 07/28/22; 2. An operating budget, capital expenditure plan and allocation of resources activities for calendar year 2021 and 01/01/22 through 10/19/22; and 3. Agency program evaluation for calendar year 2021 affecting all patients and employees. This failed practice placed the agency at risk for poor management of its resources and inability to provide optimal care and services to all patients and employees. See tag G942. Based on record review and interview, the agency failed to ensure governing body appointment of the clinical manager and/or supervising RN for the agency affecting all patients and staff. This failed practice placed the agency at risk for insufficient clinical supervision for all and had the ability to affect patient health, safety outcomes, and required employee supervision/oversite. See tag G954. Based on record review and interview, the agency failed to ensure governing body appointment of the alternate clinical manager and/or alternate supervising RN for the agency affecting all patients and staff. This failed practice placed the agency at risk for insufficient clinical oversite in the event the designated clinical manager was unavailablr, potentially affecting all patients and employees. See tag G958.

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on record review and interview the agency failed to ensure governing body oversite of: 1. A patient centered QAPI program for calendar year 2021 and 01/01/22 through 07/28/22; 2. An operating budget, capital expenditure plan and allocation of resources activities for calendar year 2021 and 01/01/22 through 10/19/22; and 3. Agency program evaluation for calendar year 2021 affecting all patients and employees. This failed practice placed the agency at risk for poor management of its resources and inability to provide optimal care and services to all patients and employees. See tag G942. Findings: A review of administrative records showed no governing body oversite of an ongoing patient centered QAPI program, operating budget, and capital expenditure plan, allocation of resource activities and agency program evaluation for calendar year 2021 and 01/01/22 to 10/19/22. On 10/19/22 at 3:00 p.m., Staff A stated there was no documentation which showed governing body oversight for the agency for a patient centered QAPI program, an operating budget, capital expenditure plan and allocation of resources activities for calendar year 2021 and 01/01/22 through 10/19/22; and an agency program evaluation for calendar year 2021.

Ensures qualified pre-designated person CFR(s): 484.105(b)(2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure governing body appointment of the clinical manager and/or supervising RN for the agency affecting all patients and staff. This failed practice placed the agency at risk for insufficient clinical supervision for all and had the ability to affect patient health, safety outcomes, and required employee supervision/oversite. Findings: A review of administrative records for calendar year 2021 and 01/01/22 through 10/19/22 showed no appointment of the clinical manager and/or supervising RN by the governing body for the agency. On 10/19/22 at 3:00 p.m., Staff A stated the governing body minutes for calendar year 2021 and for 01/01/22 through 10/19/22 were provided in their entirety and did not document a designation of the clinical manager and/or supervising RN for the agency.

Clinical manager CFR(s): 484.105(c) Standard: Clinical manager. One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following-- This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure governing body appointment of the alternate clinical manager and/or alternate supervising RN for the agency affecting all patients and staff. This failed practice placed the agency at risk for insufficient clinical oversite in the event the designated clinical manager was unavailablr, potentially affecting all patients and employees. Findings: A review of administrative records for calendar year 2021 and for 01/01/22 through 10/19/22 showed no appointment of the alternate clinical manager and/or alternate supervising RN by the governing body for the agency. On 10/19/22 at 3:00 p.m., Staff A stated the governing body minutes for calendar year 2021 and 01/01/22 through 10/19/22 were provided in their entirety and did not document a designation of the alternate clinical manager and/or alternate supervising RN for the 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 reviews and interview, the agency failed to ensure a completed discharge summary was provided for two (Patients #6 and #7) of seven patients. Findings: Patient #6 A review of the clinical record documented discharge from the agency on 05/25/22 to in-patient hospital provider services. Documentation showed no discharge summary was provided to the in-patient hospital service provider. Patient #7 A review of the clinical record documented discharge from the agency on 09/09/22 to in-patient hospital provider services. Documentation showed no discharge summary was provided to the in-patient hospital service provider. On 10/19/22 at 11:30 a.m., Staff C stated no transfer summary was sent to the receiving service providers for Patient #6 and #7.