Holistic Home Care Home Health, LLC

“Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure a community-based risk assessment (All Hazards Risk Assessment) for the agency was developed and implemented for all patients and employees. Findings: A review of administrative records showed no community-based risk assessment for the agency. On 03/05/25 at 12:00 p.m., Staff A stated the agency did not have an AHRA.”

“Local, State, Tribal Collaboration Process CFR(s): 484.102(a)(4) §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.542(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure development, implementation and maintenance of processes and contact information for an integrated emergency preparedness response with Federal, State, Tribal, Regional and Local emergency management officials since emergency preparedness plan requirement date of 11/15/17 for all patients and employees. Findings: A review of administrative records showed no administrative processes and/or resource contact information for an integrated emergency preparedness response with Federal, State, Tribal, Regional and Local emergency management officials for the agency. On 03/05/24 at 12:00 p.m., Staff B stated the agency did not have an Emergency Preparedness Plan with administrative processes and resource contact information for an integrated emergency preparedness response with Federal, State, Tribal, Regional and Local emergency management officials.”

“Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO’s Donation Service Area (DSA). This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure an Emergency Preparedness Communication Plan included updated required information related to current employee contact information for the agency since emergency preparedness plan requirement date of 11/15/17, for all patients and employees. Findings: Administrative records showed no updated Emergency Preparedness Communication Plan which included current employee contact information for the agency. On 03/05/25 at 12:00 p.m., Staff A stated the Emergency Preparedness Communication Plan was not updated to include contact information for current employees of the agency.”

“EP Training and Testing CFR(s): 484.102(d) §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the emergency preparedness annual testing and training program was followed for all employees. Findings: A review of administrative records showed no annual emergency preparedness plan training for employees for calendar years 2023 and 2024. On 03/05/25 at 12:00 p.m., Staff A stated: 1. The agency did not do emergency preparedness training for employees in calendar years 2023 and 2024. 2. The agency lost paperwork in a flood in May of 2024 and the date of the last annual employee training is unknown.”

“EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure emergency preparedness disaster table-top exercises, drills, community drills or plan activation events were completed from 05/12/23 to 03/04/25 for all patients and employees. Findings: A review of administrative records for emergency preparedness showed no emergency preparedness disaster table-top exercises, drills, community drills or plan activation events from 05/12/23 to 03/04/25. On 03/05/25 at 12:00 p.m. Staff A stated the emergency preparedness program for the agency showed no table-top exercises, drills, community drills or plan activation events from 05/12/23 to 03/04/25.”

“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 quality indicator data to improve program effectiveness, quality of patient care and overall program improvement for all patients and employees. Findings: A review of administrative QAPI records for calendar years 2023 and 2024 showed no quality indicator data collection sources from OASIS reporting utilized in the analysis of data in the agency’s QAPI Program. On 03/06/25 at 11:45 p.m., Staff A stated: 1. All QAPI program documentation for the agency was provided in its entirety; and 2. QA documentation for the calendar years 2023 and 2024 showed no collection or analysis of quality indicator data from OASIS reporting.”

“Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA’s services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This Standard is not met as evidenced by: Based on record review and interviews, the agency failed to ensure performance improvement project documentation for the agency in calendar years 2023 and 2024 for all patients and employees. Findings: A review of QAPI Program documentation showed no performance improvement project documentation for calendar years 2023 and 2024. On 03/06/25 at 11:45 p.m., Staff A stated the agency had no QAPI PIP documentation for calendar years 2023 and 2024.”

“Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This Standard is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure infection prevention practices in the storage of clean and sterile supplies stored on a wire shelving rack against a wall inside of the agency for all patients and employees. Findings: On 03/05/25 at 9:30 a.m., Upon arrival at the agency the OSDH surveyor observed the clean and sterile supply storage area designated for patient and staff use. The agency was located inside building (previously used as a convenience store) that was cluttered with debris, dirt, dust and had delipidated counters, cold storage units cluttered with papers, boxes and beverage containers and had a cardboard box full of cat litter with an overpowering odor of cat urine sitting in the floor next to the counter in front of the entry door. Clean and sterile supplies were located on the west wall of the building sitting on wire shelving racks leaning against the wall. Dark black and white spotting on the wall and ceiling above, behind and below the wire shelving racks in addition to dust and hanging spider webs, were observed in contact with the clean and sterile supplies sitting on the wire shelving racks. On 03/06/25 at 12:00 p.m., Staff A stated: 1. The agency had moved to the present location after a flood in May of 2024 as a temporary location until a more permanent location could be found. 2. We did not want to spend a lot of money to clean this place up because we didn’t intend to be here this long. 3. The clean and sterile supplies shouldn’t have been stored in contact with black and white spotted areas on the wall and ceiling with dust and hanging spider webs touching the supplies.”

“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 the Infection Control Program surveillance data was included in QAPI program activities for calendar years 2023 and 2024 for all patients and employees. Findings: A review of an administrative policy titled “Quality Assurance” stated the agency will report infection surveillance as a part of Quality Assurance reporting. A review of QAPI administrative records showed no documentation of infection control surveillance data through the QAPI program for calendar years 2023 and 2024. On 03/06/25 at 12:00 p.m., Staff A stated infection surveillance activities were not reported through the agency’s QAPI program for calendar years 2023 and 2024.”

“Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This Standard is not met as evidenced by: Based on observation and interview, the agency failed to ensure paper clinical records were securely stored for all patients. Findings: On 03/05/25 at 9:30 a.m., Upon arrival at the agency the OSDH surveyor observed boxed paper clinical records (marked as “patient records”) stored in the open next to the entry doors of the agency. The boxed paper clinical records were sitting on wire racks along the west wall of the building and scattered about on the floor in front of the wire racks. On 03/06/25 at 12:00 p.m., Staff A stated the clinical patient records should not be stored in an unsecured, open area of the agency.”

“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 record review and interview, the agency failed to ensure advance beneficiary notice and/or HHCOC notice were provided to one (Patient #8) of eight patients. Findings: Patient #8 A review of the clinical record showed no physician order for discharge, no advance notice of discharge, home health change of care notice, or physician communications prior to the patient’s discharge from the agency on 11/29/24 for no insurance authorization for services. On 03/06/25 at 11:30 a.m., Staff A stated there were no ABN or HHCOC notices or physician communications in the clinical record prior to the patient being discharged from the agency for no insurance authorization for services.”

“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 updated for ordered medications for one (Patient #1) of eight patients. Findings: Patient #1 Patient #1 A review of the clinical record showed a POC dated 02/14/25 to 04/14/25. A SN visit note dated 02/27/25 documented the patient reported the physician had ordered an extra dose of torsemide on 02/28/25. Documentation showed no notification/clarification of order with the physician. The SN note documented the SN added a one-time extra dose of medication to the patient’s med planner for 02/28/25. Documentation showed no follow up review or update to the medication profile by the SN, showed no physician notifications, and no change in orders. On 03/05/25 at 11:05 a.m., Staff A stated the medication profile showed no follow up review or update to the medication profile by the SN.”

“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 individualized patient POC included: 1. SN visit frequency and duration of services for two (Patients #1 and #7) of eight patients. 2. SN intervention for assessment and instruction for management of weight showed for one (Patients #5) of eight patients. Findings: Patient #1 A review of the POC dated 02/14/25 to 04/14/25 showed orders for CHHA to assist with personal care services. Documentation showed no CHHA visit frequency and duration of service. Documentation showed no CHHA visit, no physician notifications and no change in orders. On 03/06/25 at 11:05 a.m., Staff A stated the POC documentation should not have included CHHA services when the recertification was completed. Patient #5 A review of the POC dated 01/31/25 to 03/31/25 showed orders for SN to assess and instruct the patient’s weight every visit. POC documentation identified no physician weight reporting parameters. Documentation showed patient reported weight during SN visits dated 01/16/25 of 294 pounds, 01/24/25 of 288 pounds, 01/30/25 of 289 pounds, 02/06/25 of 284 pounds, 02/13/25 of 289 pounds, and on 02/27/25 of 295 pounds. Documentation showed no physician notifications and no change in orders. On 03/06/25 at 11:20 p.m., Staff A stated the POC documentation identified no physician reporting parameters for the patient’s weight levels. Patient #7 A review of the POC dated 12/18/24 to 02/15/25 showed orders for SN frequency and duration of one time a week for two weeks effective week of 03/14/25 (date outside of certification period). Documentation showed SN visits dated 12/16/24, 12/23/24, 12/31/24, 01/07/25, 01/14/25, 01/21/25, 01/28/25, 02/06/25 and 02/11/25. Documentation showed no physician notifications and no change in orders. On 03/06/25 at 1:25 p.m., Staff A stated the POC documentation should have included a frequency and duration of SN services for the time period of the certification period.”

“All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure physician orders were a part of the patients’ POCs for two (Patients #2 and #7) of eight patients. Findings: Patient #2 A review of the POC dated 01/06/25 to 03/06/25 showed no orders for PT to evaluate and treat with a frequency and duration effective 01/08/25 of one time a week for one week, two times a week for three weeks, then one time a week for one week. A PT reassessment dated 02/04/25 showed a continuation of PT services with a frequency and duration of one time a week for one week, two times a week for two weeks, then one time a week for one week. Documentation showed no physician notification, coordination of care communications and no written order. On 03/06/25 at 11:12 a.m., Staff A stated the documentation showed no physician notification by the PT and no written order for the continuation of PT services. Patient #7 A review of the POC dated 12/18/24 to 02/15/25 showed orders for SN frequency and duration of one time a week for two weeks, effective 03/14/25 (date beyond certification period range). Documentation showed SN visits were conducted on 12/23/24, 12/31/24, 01/07/25, 01/14/25, 01/21/25, 01/28/25, 02/06/25 and on 02/11/25. Documentation showed no physician notification, coordination of care communications and no written order. On 03/06/25 at 11:25 a.m., Staff A stated the POC SN visit frequency and duration of one time a week for nine weeks was not documented on the POC.”

“Communication with all physicians CFR(s): 484.60(d)(1) Standard: Coordination of Care. The HHA must: (1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure care was coordinated between the agency and physician for three (Patients #4, 5 and #8) of eight patients. Findings: Patient #4 A review of the POC dated 01/30/25 to 03/30/25 showed a diagnosis of Diabetes Mellitus Type II. Documentation of SN to review blood sugar log and report to the physician random fingerstick blood sugar 200. Documentation showed during SN visits dated 01/30/25 level of 237, 02/06/25 level of 262, 02/13/25 level of 271. Documentation showed no follow up physician communications or coordination of care notes related to patient continued elevated FSBS and showed no changes in orders. On 03/06/25 at 11:18 a.m., Staff A stated the SN should have communicated the patient’s continued elevated FSBSs with the physician. Patient #5 A review of the POC dated 01/31/25 to 03/31/25 showed diagnoses of congestive heart failure and cellulitis to the right lower extremity. The POC showed orders for SN to assess and instruct the patient’s weight every visit related to congestive heart failure management. POC documentation identified no physician weight reporting parameters. Documentation showed patient reported weight during SN visits dated 01/24/25 of 288 pounds, 01/30/25 of 289 pounds (+1 pound in one week), 02/06/25 of 284 pounds, 02/13/25 of 289 pounds (+5 pounds in one week, and on 02/27/25 of 295 pounds (+6 pounds in 2 weeks). Documentation showed no follow up physician communications or coordination of care notes related to patient continued elevated weight, symptoms of congestive heart failure and showed no changes in orders. On 03/06/25 at 11:20 p.m., Staff A stated the SN should have communicated the patient’s continued weight gain with the physician. Patient #8 A review of the POC dated 10/23/24 to 12/21/24 showed documentation of SN to assess and report to the physician patient’s pain levels greater than 6 of 10. Documentation showed during SN visits dated: 1. 10/31/24 reported pain level of 7 of 10, 2. 11/11/24 reported pain level of 7 of 10, and 3. 11/18/24 reported pain level of 7 of 10. Documentation showed no physician communications or coordination of care notes related to patient continued reported pain levels of 7 of 10 and showed no changes in orders. On 03/06/25 at 11:30 a.m., Staff A stated the SN should have communicated the patient’s continued reported pain levels of 7 of 10 with the physician.”

“Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure SN assess and monitored the patients pain level every visit and reported pain levels greater than 5 of 10 to the physician for one (Patients #3) of eight patients. Findings: Patient #3 A review of the POC dated 01/04/25 to 03/04/25 showed orders for SN frequency and duration of one time a week for nine weeks to assess the patient’s pain level and instruct pain management interventions every visit. Documentation showed SN visits dated 01/16/25 reported a pain level of 10 of 10. Documentation showed no physician notification and no changes in orders. On 03/06/25 at 11:15 a.m., Staff A stated the SN should have contacted the physician and reported the patient’s pain level during the visit.”

“Participate in the HHA’s QAPI program; CFR(s): 484.75(b)(8) Participation in the HHA’s QAPI program; and This Element is not met as evidenced by: Based on a record review and interview, the agency failed to ensure multi-disciplined skilled professional staff were available to participate and provide input into the agency’s QAPI program for all patients and employees. Findings: A review of administrative QAPI records showed no multi-disciplined skilled professional staff (PT, OT, ST or MSW in addition to SN) participation in QAPI activities for calendar years 2023 and 2024. On 03/06/25 at 12:00 p.m., Staff A stated there were no multi-disciplined skilled professional staff participation in ongoing QAPI program activities for the agency for calendar years 2023 and 2024.”

“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 interviews, the agency failed to ensure a completed discharge summary was provided to receiving service providers for one (Patient #6) of eight patients. Findings: Patient #6 A review of the clinical record showed discharge from the agency on 01/08/25 to hospice provider services. Documentation showed no discharge summary was provided to the receiving hospice service provider as of 03/06/25. On 03/06/25 at 11:22 a.m., Staff A stated no discharge summary was sent to the receiving service providers for patients #6.”