Strong Hold Home Health, Inc.

“Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.542, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms “facility” or “facilities” in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This Condition is not met as evidenced by: (E004) Based on record review and staff interview it was determined the facility failed to maintain, update and evaluate the Emergency Preparedness Plan. This deficient practice has the potential that the facility is not prepared for emergency situations posing the risk for both patient and employee harm. (E0017) Based on record review and staff interview it was determined the facility failed to implement policies and procedures in its emergency plan for ensuring all patients have an individualized plan in the event of an emergency. This deficient practice has the potential that the patient will not prepared in the event of emergency situations posing the risk for negative patient outcomes. (E0036) Based on record review and staff interview it was determined the facility failed to maintain an emergency preparedness training and testing program that has been documented, reviewed and updated. This deficient practice has the potential that the facility is not prepared for emergency situations posing the risk for both patient and employee harm. (E0037) Based on record review and staff interview it was determined the facility failed to provide training on their facility’s emergency plan at least every 2 years. This deficient practice has the potential that the facility is not prepared for emergency situations posing the risk for both patient and employee harm. (E0039) Based on record review and staff interview it was determined the facility failed to perform testing exercise for the Emergency Preparedness Plan. This deficient practice has the potential that the facility is not prepared for emergency situations posing the risk for both patient and employee harm. The cumulative effect of these systematic deficient practices resulted in the facility’s failure to meet the requirement for Condition of Participation for Establishment of Emergency Program which poses the risk of harm to patients and employees in emergency situations.”

“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: (G0644) Based on record review and staff interview it was determined that the facility failed to monitor the effectiveness and safety of services and quality of care, and identify opportunities for improvement. This deficient practice has the potential that patient needs and program evaluations are not being recognized, addressed and corrected, posing the risk for poor patient care and negative outcomes. (G0660) Based on record review and staff interview it was determined that the facility failed to have an ongoing quality management program designed to monitor the effectiveness and safety of services and quality of care, and identify opportunities for improvement. This deficient practice has the potential that patient needs and program evaluations are not being recognized, addressed and corrected, posing the risk for poor patient care and negative outcomes. The cumulative effect of these deficient practices resulted in the facility’s failure to meet the requirement for Condition of Participation for Quality Assessment/Performance Improvement which poses a risk for poor patient care and increased negative outcomes.”

“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: (G0682) Based on record review, observation and staff interview, it was determined the facility failed to demonstrate proper infection control technique. This deficient practice has the potential that cross contamination of biohazardous pathogens could be spread to a vulnerable population, posing the risk for a negative patient outcome. (G0686) Based on record review and staff interview it was determined the facility failed to ensure infection control education was provided to staff at periodic intervals consistent with accepted standards of practice. Such education must be provided at orientation, annually, and as needed to meet the staff’s learning needs. This deficient practice has the potential that staff members are not being educated on the most current and evidenced-based practice posing the risk for vulnerable patients to be susceptible to infectious disease leading to poor patient outcomes. (G1024) Based on record review and staff interview, it was determined the facility failed to authenticate signatures. This deficient practice has the potential that unauthenticated signatures pose the risk for fraud. The cumulative effect of these deficient practices resulted in the facility’s failure to meet the requirement for Condition of Participation for Infection Prevention and Control which can lead to increased risk for vulnerable patients to be susceptible to infectious disease processes and poor patient outcomes.”

“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), §485.542(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 staff interview it was determined the facility failed to maintain, update and evaluate the Emergency Preparedness Plan. This deficient practice has the potential that the facility is not prepared for emergency situations posing the risk for both patient and employee harm. Findings Include: A review of Strong Hold Home Health Policy Number CLN.020, titled “Emergency & Natural Disasters Plan” revealed “...Quality Assurance Performance Improvement (QAPI) Monitoring: The QAPI department will conduct an annual review of the emergency plan and monitor the effectiveness of the Emergency Preparedness program...”. A request was made for the Emergency Preparedness Plan (EPP). No documentation could be provided. A document titled “Strong Hold Home Health Emergency Preparedness Packet” was provided. This document revealed “...Prepared by: The National Association for Home Care & Hospice...”. In an interview with Employee #1 conducted on February 15, 2024, he/she confirmed that no EPP was available. He/she also confirmed that the aforementioned “packet” was a “template” and not Strong Hold Home Health’s EPP. Additional Employee #1 confirmed the EPP was currently being stored offsite at another healthcare entity.”

“HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA’s patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This Standard is not met as evidenced by: Based on record review and staff interview it was determined the facility failed to implement policies and procedures in its emergency plan for ensuring all patients have an individualized plan in the event of an emergency. This deficient practice has the potential that the patient will not prepared in the event of emergency situations posing the risk for negative patient outcomes. Findings Include: A request for the patient individualized emergency plan policy was requested. No document was provided. An interview with Employee #1 conducted on February 15, 2024 confirmed the aforementioned policy could not be provided.”

“EP Training and Testing CFR(s): 484.102(d) §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(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 staff interview it was determined the facility failed to maintain an emergency preparedness training and testing program that has been documented, reviewed and updated. This deficient practice has the potential that the facility is not prepared for emergency situations posing the risk for both patient and employee harm. Findings Include: A request for the training and testing program documentation was asked for and not received. An interview with Employee #1 conducted on February 15, 2024 confirmed the aforementioned documentation could not be provided. Additionally, Employee #1 confirmed the training and testing documentation was stored offsite at another healthcare entity.”

“EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, “Organizations” under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF’s emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This Standard is not met as evidenced by: Based on record review and staff interview it was determined the facility failed to provide training on their facility’s emergency plan at least every 2 years. This deficient practice has the potential that the facility is not prepared for emergency situations posing the risk for both patient and employee harm. Findings Include: A review of Strong Hold Policy number CLN.020 titled, “Emergency & Natural Disasters Plan” revealed, “...Orientation and In-Service...Personnel will attend orientation upon hire and an annual update of their specific roles and responsibilities and the skills they require to perform their duties during an emergency...The Administrator is responsible for in-servicing personnel at the Agency wide emergency management program...”. A review of personnel files for Employee’s #1, 2, 3, 4, 5, 6, 7, and 8 revealed no evidence of annual in-services for training of the emergency preparedness program. An interview with Employee #1 conducted on February 14, 2024, he/she confirmed that no evidence of annual in-service training for the aforementioned employees was present in the personnel files. No additional documentation could be provided.”

“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 staff interview it was determined the facility failed to perform testing exercise for the Emergency Preparedness Plan. This deficient practice has the potential that the facility is not prepared for emergency situations posing the risk for both patient and employee harm. Findings Include: A Strong Hold Home Health Policy #CLN.020 titled, “Emergency & Natural Disasters Plan”, revealed “...The agency will have a practice drill annually to help the QAPI department and Administrator evaluate the adequacy if emergency plan...”. A request was made for the practice drill. No documentation was provided. An interview with Employee #1 was conducted on February 15, 2024, he/she confirmed the practice drill documentation was not present. No additional documentation could be provided.”

“Transfer and discharge CFR(s): 484.50(d) Standard: Transfer and discharge. The patient and representative (if any), have a right to be informed of the HHA’s policies for transfer and discharge. The HHA may only transfer or discharge the patient from the HHA if: This Standard is not met as evidenced by: Based on record review and staff interview, it was determined the facility failed to notify the patient and representative in the event of a change in patient admission status or that the patient’s plan of care should be altered. This deficient practice has the potential risk of patient harm and/or negative patient outcome. Findings Include: A Strong Hold Home Health Policy #CLN.005 titled, “Physician Communication & Receiving Orders”, revealed “...Procedure:...All communication with the physician shall be documented in the medical record. Communication with a patient’s physician is required in the following cases: Upon admission, re-certification or discharge. A change in the patient’s condition occurs...When the patient is non-complaint [sic] to the established plan of care...”. Review of Patient #7 medical record revealed, skilled nurse arrived at patient’s home on 12/5/2023. Patient not answering to knocks on door. No phone call was made to emergency contact or the physician. Voicemail left for social worker. Patient discharge on 1/11/2024 for multiple reasons. Reason #1, “...Patient discharged due to not home at the time of recertification...discharge disposition: Where is the patient after discharge from your agency?...UK-other unknown...” Reason #2, “...Discharge patient from home care services...”. No evidence of communication with patient was present in the medical record. An interview with Employee #1 conducted on February 15, 2024 he/she confirmed physician was not contacted. No additional documentation could be provided.”

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on record review and staff interview it was determined the facility failed to provide a signed patient plan of care. This deficient practice has the potential that the patient is not receiving services approved by the physician posing the risk of negative patient outcomes. Findings Include: A Strong Hold Home Health Policy #CLN.010 titled “Patient Plan of Care” revealed, “...Procedure:...4. The patient’s physician, registered nurse practitioner, or podiatrist, as applicable, authenticated the care plan with a signature within 30 calendar days after the care plan is initially developed and whenever the care plan is reviewed or updated...”. A review of seven(7) patient medical records revealed no signed plan of cares for 7 out of 7 patients. A review of Patient #7 medical record revealed that the plan of care was being sent to the incorrect physician. Physician on record was documented as having a Michigan (MI) address, phone number and fax number. The physician order originated from Phoenix, Arizona. An interview with Employee #1 conducted on February 14, 2024 he/she stated the plan of cares for the aforementioned patients were electronically signed. A request of an electronic access report to verify signatures, dates and time of authenticated plan of care could not be provided. A second request for this report was made on February 15, 2024 and could not be provided.”

“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 staff interview it was determined that the facility failed to monitor the effectiveness and safety of services and quality of care, and identify opportunities for improvement. This deficient practice has the potential that patient needs and program evaluations are not being recognized, addressed and corrected, posing the risk for poor patient care and negative outcomes. Findings Include: A Strong Hold Home Health Policy #QMI.013 titled, “Quality Management & Performance Improvement” revealed, “...Policy...The QM/PI Program is on-going, systematic and objective process of the agency and patient care services...The Administrator shall ensure that a plan for a Quality Management Program is established, documented, and implemented that includes: a method to identify, document, and evaluate incidents;...a method to evaluate the data collected to identify a concern about the provision of services...a method to determine whether actions taken improved the provision of services; and...Plan:...QI Meetings will be held as often as necessary, but no less than once every six (6) months, to address monitoring results and issues identified through the QI process...”. In an interview with Employee #1 conducted on February 14, 2024, he/she confirmed the only Quality indicator being measured is patient satisfaction surveys. He/she also confirmed the patient satisfaction survey data is not being utilized to improve patient care and/or outcomes.”

“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 staff interview it was determined that the facility failed to have an ongoing quality management program designed to monitor the effectiveness and safety of services and quality of care, and identify opportunities for improvement. This deficient practice has the potential that patient needs and program evaluations are not being recognized, addressed and corrected, posing the risk for poor patient care and negative outcomes. Findings Include: A Strong Hold Home Health Policy #QMI.013 titled, “Quality Management & Performance Improvement” revealed, “...Policy...The QM/PI Program is on-going, systematic and objective process of the agency and patient care services...The Administrator shall ensure that a plan for a Quality Management Program is established, documented, and implemented that includes: a method to identify, document, and evaluate incidents;...a method to evaluate the data collected to identify a concern about the provision of services...a method to determine whether actions taken improved the provision of services; and...Plan:...QI Meetings will be held as often as necessary, but no less than once every six (6) months, to address monitoring results and issues identified through the QI process...”. In an interview with Employee #1 conducted on February 14, 2024, he/she confirmed the only Quality indicator being measured is patient satisfaction surveys. He/she also confirmed the patient satisfaction survey data is not being utilized to improve patient care and/or outcomes due to surveys being 100%. No additional information could be provided.”

“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 record review, observation and staff interview, it was determined the facility failed to demonstrate proper infection control technique. This deficient practice has the potential that cross contamination of biohazardous pathogens could be spread to a vulnerable population, posing the risk for a negative patient outcome. Findings Include: A review Strong Hold Home Health policy and procedures table of content revealed no policy for bag technique and policy for cleaning/disinfecting of reusable patient care devices. A request for bag technique policy and cleaning/disinfecting of reusable patient care devices was asked for and not received. During a home visit it was observed that Employee #8 did not place a barrier between his/her bag and surface. It was also observed that after using reusable patient care devices (thermometer, blood pressure cuff, pulse oximeter, and stethoscope) the devices were placed back in to his/her bag without proper disinfection. An interview with Employee #1 conducted on February 15, 2024, he/she confirmed aforementioned policies were unavailable. No additional documentation could be provided.”

“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 staff interview it was determined the facility failed to ensure infection control education was provided to staff at periodic intervals consistent with accepted standards of practice. Such education must be provided at orientation, annually, and as needed to meet the staff’s learning needs. This deficient practice has the potential that staff members are not being educated on the most current and evidenced-based practice posing the risk for vulnerable patients to be susceptible to infectious disease leading to poor patient outcomes. Findings Include: A review Strong Hold Home Health Policy #QMI.019 titled, “Infection Control Management & Assessment” revealed, “...All staff are oriented to the infection control procedures upon employment...”. A review of personnel files for Employee’s #1, 2, 3, 4, 5, 6, 7, and 8 revealed no evidence of annual in-services for training of infection prevention and/or control. A request for employee infection control in-services/education was made and no documentation could be provided. In an interview with Employee #1, conducted on February 14, 2024 and February 15, 2024, he/she confirmed that no additional information could be provided for employee in-services/education.”

“Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This Standard is not met as evidenced by: Based on record review and staff interview, it was determined the facility failed to authenticate signatures. This deficient practice has the potential that unauthenticated signatures pose the risk for fraud. Findings Include: A review of Strong Hold Home Health policy and procedure table of contents revealed no policy on authentication of signatures. A review of Strong Hold Home Health Policy #CLN.010 titled “Patient Plan of Care” revealed, “...authenticated the care plan with a signature...”. A review of seven (7) patient medical records revealed no signed documents were authenticated on 7 out of 7 patients. An interview with Employee #1 conducted on February 15, 2024, he/she stated the 7 patients medical records all contained authenticated signatures. He/she stated the current electronic medical record (EMR) system being used does not provide a time stamp when provider electronically signs. Employee #1 was afforded an opportunity to produce any evidence and/or contact the EMR provider to obtain a time stamp report. Employee #1 declined. No additional documentation could be provided.”