Revival Home Health Care, L L C

“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: Based on record review and interview, the Agency failed to ensure the Emergency Preparedness Plan included procedures to follow up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency and to inform State and local officials of any on-duty staff or patients that they are unable to contact (See E0021); failed to develop and maintain annually a communication plan complies with Federal, State, and local laws which integrated specific roles, tasks and responsibilities for all necessary individuals involved in an actual emergency (See E0029); failed to develop and maintain an emergency preparedness communication plan that included contact information for staff, entities providing services under arrangement, patient’s physicians, and other facilities/agencies that have been reviewed and updated annually (See E0030); failed to develop and implement primary and alternate means of communicating with staff, Federal, State, and local emergency management agencies (See E0032); failed to develop and maintain an emergency preparedness training and testing program that was based on the Agency’s emergency plan, risk assessment, policies, procedures, and the communication plan (E0036); and failed to provide documentation for the required annual tabletop and community based full-scale exercises or any documentation of an actual event that would qualify as a test of the emergency plan (E0039). The cumulative effect of these systemic problems could potentially have a negative effect on all 9 patients currently receiving services by this Agency in the event staff is not properly prepared for an emergency for the Condition of Participation of 42 CFR §485.102, Emergency Preparedness.”

“Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient’s medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This Condition is not met as evidenced by: Based on record review and interview, it was determined that the agency failed to attempt to reschedule missed visits to meet the visit frequency in the Plan of Care (POC) in 1 (P-6) of 7 records reviewed (G572); failed to ensure the POC included all required information in 3 (P-2, 4, 7) of 7 records reviewed (G574); and failed to ensure that treatment/interventions were provided only in accordance with physician orders in 4 (P-3, 4, 5, 6) of 7 records reviewed (G580). The cumulative effect of these systemic problems resulted in the potential for significant injury or death and a failure to ensure the provision of quality health care in a safe environment for the condition of participation of 42 CFR 484.60: Care Planning, Coordination of Services, and Quality of Care.”

“Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This Condition is not met as evidenced by: Based on record review and interview, the Agency failed to develop an Infection Control Program and monitor staff’s performance to ensure infection control policies and accepted standard precautions to prevent the transmission of infections and communicable diseases were followed (See G682); failed to maintain an agency-wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases as a part of the Agency’s Quality Assessment Performance Improvement program (See G 684); and failed to provide infection control education to staff (See G 686). The cumulative effects of these systemic problems resulted in the Agency’s inability to collect and analyze data to ensure the of provision of safe health care and failed to educate staff on concerning knowledge and interventions needed for the condition of participation of 42 CFR§484.70 Infection Prevention and Control.”

“HHA- Procedures for Follow up Staff/Pts. CFR(s): 484.102(b)(3) §484.102(b)(3) Condition of Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (3) The procedures to follow up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency. The HHA must inform State and local officials of any on-duty staff or patients that they are unable to contact. This Standard is not met as evidenced by: Based on record review and interview, the Agency failed to ensure its Emergency Preparedness Program included procedures to follow up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency and to inform State and local officials of any on-duty staff or patients that they are unable to contact, resulting in the potential for interruption of needed care and services to all 94 patients that have received services in the past 12 months. Findings include: On 3/5/25 at 1:40 PM., review of the Agency’s Emergency Preparedness (EP) documentation noted a failure to include language and procedures that clearly outlined what surrounding facilities the Agency would transfer its patients to, ensuring the continuity of appropriate patient care. Further review found no procedures that incorporated contact numbers, timelines, or indicated conditions that would warrant patient transfers. Additionally, procedures to follow up with on-duty staff and patients to determine actions needed to help minimize interruptions in patient care experienced during an emergency were not found in the Agency’s EP plan. These findings were reviewed and acknowledged by the Administrator, Clinical Manager, and Intake Manager during an interview on 3/7/25 at 2:36 PM.”

“Development of Communication Plan CFR(s): 484.102(c) §403.748(c), §416.54(c), §418.113(c), §441.184(c), §460.84(c), §482.15(c), §483.73(c), §483.475(c), §484.102(c), §485.68(c), §485.542(c), §485.625(c), §485.727(c), §485.920(c), §486.360(c), §491.12(c), §494.62(c). (c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. This Standard is not met as evidenced by: Based on record review and interview, the Agency failed to develop and maintain an Emergency Preparedness communication plan that integrated specific roles, tasks and responsibilities of its staff in the event of an actual emergency, resulting in the Agency’s inability to ensure the coordination of patient care during an emergency/disaster and the potential to negatively affect the health and safety of all 94 patients who have received services in the past 12 months. Findings include: On 3/5/25 at 1:40 PM., review of the Agency’s Emergency Preparedness documentation concerning its Communication Plan (CP) had been updated and inappropriately approved on 3/19/24. Despite the CP having a generic printing of assigned roles, tasks and responsibilities, no evidence was found that the CP had been read, implemented or tested. Further, the CP contained language of a “Sample Disaster Plan” that in detail noted how staff members would communicate and coordinate the support of patient care needs within the Agency and other healthcare providers during an emergency/disaster. Again, no evidence was found that the CP had been tested (drill or actual emergency) to ensure the content within the CP documentation would be effective. An interview was conducted on 3/5/25 at 2:05 PM. to ascertain the level of knowledge the Administrator, Clinical Manager, and Intake Manager had in essential principles outlined in the printed CP. Each were given a piece of paper to write down where the pre-arranged meeting place was outside the office if an evacuation was ordered. All three failed to write anything down. In addition, the key staff members above (3 of 3) were asked what active participation each had in the roles and responsibilities in executing or carrying out the CP during an emergency. All three were unsure and noted that they have not yet read, discussed or had training in formulating an effective CP. These findings were reviewed and acknowledged by the Administrator, Clinical Manager, and Intake Manager during an interview on 3/7/25 at 2:39 PM. It was mutually determined the Agency had an appropriate theoretical CP printed on paper but failed to demonstrate the knowledge needed to execute an effective CP, subsequently jeopardizing the needs of its patients during an emergency.”

“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 develop and maintain an Emergency Preparedness communication plan that includes the names and contact information for staff, entities providing services under arrangement, and patient’s physicians, resulting in a lack of effective communication in the event of an actual emergency. This deficient practice has the potential to negatively affect the health and safety of the Agency’s 9 current patients. Findings include: The Agency’s Emergency Preparedness Plan was reviewed on 3/5/25 at 1:40 PM. During the review, it was noted there was no documented evidence of a communication plan that included the names and contact information for staff, entities providing services under arrangement, and patient’s physicians. In addition, the communication plan had no assigned names with assigned roles/tasks to perform specific actions during an emergency to meet the needs of various acuity levels among its patients. These findings were reviewed with and acknowledged by the Administrator, Clinical Manager, and Intake Manager during an interview on 3/7/25 at 2:40 PM.”

“Primary/Alternate Means for Communication CFR(s): 484.102(c)(3) §403.748(c)(3), §416.54(c)(3), §418.113(c)(3), §441.184(c)(3), §460.84(c)(3), §482.15(c)(3), §483.73(c)(3), §483.475(c)(3), §484.102(c)(3), §485.68(c)(3), §485.542(c)(3), §485.625(c)(3), §485.727(c)(3), §485.920(c)(3), §486.360(c)(3), §491.12(c)(3), §494.62(c)(3). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (3) Primary and alternate means for communicating with the following: (i) [Facility] staff. (ii) Federal, State, tribal, regional, and local emergency management agencies. *[For ICF/IIDs at §483.475(c):] (3) Primary and alternate means for communicating with the ICF/IID’s staff, Federal, State, tribal, regional, and local emergency management agencies. This Standard is not met as evidenced by: Based on record review and interview, the Agency failed to develop and maintain an emergency preparedness communication plan that included primary and alternate means for communicating with staff, Federal, State, tribal, regional, and local emergency preparedness officials, resulting in a lack of an effective and tested framework to coordinate a response during an emergency. This deficient practice could affect the health and safety of the Agency’s 9 current patients in the event of an actual emergency. Findings include: The Agency’s Emergency Preparedness Plan was reviewed on 3/5/25 at 1:40 PM. During the review, it was noted that there was no documented evidence of a communication plan that included primary and alternate means for communicating with staff, Federal, State, and local emergency preparedness officials. During an interview on 3/5/25 at 2:08 PM., the Administrator, Clinical Manager, and Intake Manager were queried concerning what methods of communication were in place and tested to coordinate with Emergency Preparedness authorities noted above. Each of the three key staff members failed to provide appropriate responses that would meet this requirement. These findings were again reviewed and acknowledged by the Administrator, Clinical Manager, and Intake Manager during an interview on 3/7/25 at 2:39 PM.”

“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 upon record review and interview, the Agency failed to develop a training program which would test the two highest risk hazards identified in the all-hazard risk assessment during the last two years, resulting in an increased potential for harm for the 11 Agency staff members and the 9 active patients currently receiving services in the event of an emergency. Findings include: On 3/5/25, review of the Agency’s EP (Emergency Preparedness) binder found no evidence of staff participation, or documentation of an AAR (After Action Report) concerning the required Agency-wide testing drill(s) within the last two years. Further review noted the all-hazards risk assessment identified “Ice Snow” and “Flooding” as scoring an “8” both in 2024 and 2023. The assessment documented for both years “Any score =/> (greater) than 6, Agency has a plan for.” Evidence of the Agency having a plan based off the level 8 “Ice Snow” and “Flooding” events was not found. Evidence of training and testing the “Ice Snow” and “Flooding” scenarios was not found. Evidence of Agency staff participation in any training or testing drills (Agency specific or Community-based) was not found. These findings were reviewed with and acknowledged by the Administrator, Clinical Manager, and Intake Manager during an interview on 3/7/25 at 2:41 PM. The Agency failed to adhere to its policy referenced below. Agency Policy: “Emergency Management Policy” (undated) pg. 7 stated, “Training for all employees will be done at hire at least every 2 years thereafter and documented.””

“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 provide documentation for the required Agency and Community based full-scale exercises and failed to provide documentation of an actual event that would qualify as a test of its emergency plan, resulting in staff being ill-prepared in the event of an actual emergency and the potential for poor patient outcomes. This deficient practice could negatively affect the 11 staff members employed, and the 9 active patients currently serviced by this Agency. Findings include: On 3/5/25 at 1:40 PM., review of the Agency’s Emergency Preparedness binder found no evidence the Agency had conducted the required full-scale community-based exercise every two years. There was documentation that acknowledged the community drill needed to take place on 6/30/24 and 10/21/24. However, evidence that any staff member or actions by the Agency that showed any participation in the required full-scale community exercise in the last 3 years was not found. Regarding the Agency based testing drills, documentation of a theoretical sample disaster drill was noted on 4/10/24 and 2/1/23. The 4/10/24 and 2/1/23 table-top testing drills had 21 and 19 scenario questions respectively to show discussion/participation of findings that would be generated by running the drill. No evidence was found in the Agency’s records that indicated any input concerning the 21 and 19 scenario questions. No narrative or documentation was evidenced that indicated the any of the drills above had taken place. The above findings were reviewed with and acknowledged by the Administrator, Clinical Manager and Intake Manager during an interview on 3/7/25 at 2:43 PM. All three staff above acknowledged that they had not participated in any emergency preparedness drills since 2022.”

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to attempt to reschedule missed visits to meet the visit frequency in the plan of care in 1 (P-6) of 7 records reviewed, resulting in the potential for unmet care needs and poor patient outcomes. Findings include: P-6: This 93-year-old patient was admitted to this home care agency on 12/3/24 with the diagnoses of lumbar (low back) disc degeneration, low back pain, and hypertension (high blood pressure). During record review on 3/6/25, it was noted skilled nursing services were started 1 time a week for 5 weeks following a resumption of care on 12/18/24. Upon further review of the record, it was noted the nurse documented a missed visit on 12/25/24 due to “No Answer to Phone Call.” According to the documentation, the doctor and supervisor were notified, however, there was no documentation regarding attempts to reschedule the visit to meet the visit frequency in the plan of care. Findings were reviewed with and acknowledged by the Administrator (Staff A), the Clinical Manager (Staff B), and the Intake Manager (Staff C) during an interview on 3/7/25 at 1:20 PM.”

“Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This Standard is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to develop, implement, and maintain a Quality Assessment and Performance Improvement (QAPI) program which provided documentation of its efforts to measure, track and analyze quality indicators that represented pre-established performance improvement projects (PIP’s) designed to optimize patient care services, resulting in the inability to determine the quality of services provided and the potential unmet care needs for all 9 active patients currently being served by this agency. Findings include: On 3/6/25, the Agency’s QAPI documentation was reviewed which revealed a failure to document efforts to systematically collect data, monitor, analyze and improve patient outcomes based off Governing Body approved PIP’s. The QAPI binder contained 4 QAPI meetings (4/5/23, 4/3/24, 7/10/24, and 12/3/24) with identical agenda items containing 14 discussion topics such as PIP updates, medication errors, satisfaction surveys etc. Each of the 4 noted QAPI meetings had no printed means to identify names or titles, only signatures/titles that over half were deemed illegible. None of the 4 QAPI meetings had evidence of discussions, actions or interventions concerning any of the 14 discussions topics. Further, evidence of a PIP with data that could be tracked and trended used to generate actions/interventions for quality improvement was not found within the QAPI program. These findings were reviewed with and acknowledged by the Administrator, Clinical Manager, and Intake Manager during an interview on 3/7/25 at 2:45 PM. The Agency failed to adhere to its policy referenced below. Agency Policy: “QAPI Program/Performance Improvement” (undated) pg. 2 stated, “The agency MUST take actions aimed at PI and after implementing those actions, the agency MUST measure its success and track performance to ensure improvement is sustained.””

“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, it was determined the Agency failed to collect and use data to monitor the effectiveness, safety of services and quality of care and identify opportunities for improvement by the quality assessment and performance improvement (QAPI) program, which had the potential to negatively affect all 94 patients serviced by the Agency during the past 12 months, resulting in a potential for poor patient outcomes due to the provision of substandard care. Findings include: On 3/6/25, the Agency’s QAPI documentation was reviewed which revealed a failure to document efforts to systematically collect program data that was based off Governing Body approved PIP’s (performance improvement projects). The QAPI binder contained 4 QAPI meetings (4/5/23, 4/3/24, 7/10/24, and 12/3/24) that contained no PIP data that could be tracked and trended towards pre-established goals for improved quality measures. The lone aspect within the QAPI program was documentation of printouts of OASIS (Outcome and Assessment Information Set) data summary without any evidence of tracking and trending the data in a meaningful way to be applied towards pre-established PIP goals identified and approved by the Agency’s Governing Body. The above findings were reviewed with and acknowledged by the Administrator, Clinical Manager and Intake Manager during an interview on 3/7/25 at 2:47 PM.”

“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 interview, it was determined the Agency failed to develop a Performance Improvement Project (PIP) within its QAPI (Quality Assessment Performance Improvement) program that documented the reasons for conducting these projects with measurable progress achieved for the chosen PIPs for the last three years, resulting in the Agency’s inability to effectively monitor proposed improvements in patient care, health outcomes, patient safety, quality of care and overall performance. Findings include: On 3/6/25, the Agency’s QAPI documentation was reviewed and found no evidence of a PIP that was chosen and approved to gather information to track and tread towards pre-established goals for quality improvement for the last 3 years. The above findings were reviewed with and acknowledged by the Administrator, Clinical Manager and Intake Manager during an interview on 3/7/25 at 2:45 PM. All three staff above acknowledged that they had not participated in any PIPs in the last 3 years.”

“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 and interview, the Agency failed to develop an Infection Control Program which monitored staff’s performance to ensure infection control policies and accepted standard practices to prevent the transmission of infections and communicable diseases were followed since March 2022, resulting in a lack of oversight concerning infection control practices used during patient care by Agency staff. This deficient practice could affect the health and safety of all Agency staff and the nine patients currently receiving services. Findings include: On 3/6/2025 at 1130 AM., a request was submitted to review the Agency’s Infection Control Committee (ICC) meeting minutes and overall documentation for the last 3 years. Documentation of staff audits/education regarding infection control topics and standard precautions used to mitigate pathogen exposure to patients was not evidenced within the Agency’s QAPI (Quality Assessment and Performance Improvement) Infection Control Program. The Agency’s ICC had failed to document within the last 3 years any narrative/discussion pertaining to infection control policies, procedures and the monitoring of staff performance to ensure that infection control practices were performed appropriately.”

“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 maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases as a part of the Agency’s QAPI (Quality Assessment Performance Improvement) program, resulting in the potential spread of infections between patient care staff and the Agency’s 94 patients admitted in the past year. Findings include: On 3/6/25, the Agency’s QAPI program concerning infection control documentation was reviewed. The documentation consisted of 5 QAPI meeting dates since 2023: 4/5/23, 12/3/24, 4/3/24, 7/10/24, and 10/3/24. Each meeting had the same template of 16 agenda items (including infection control of patients and staff) along with illegible signatures with no identifiable name and title. No evidence was found within the Agency’s QAPI meeting minutes of any narrative or discussions concerning the 16 agenda items. Each QAPI meeting above failed to document any discussions or narrative regarding the Agency’s infection control program. Since 2023, documentation of infection control data with coordinated analysis, discussions with resultant actions for improvement were not found during the recertification survey. The findings above were reviewed with the Administrator (Staff A), Clinical Manager (Staff B) and Intake Manager (Staff C) during an interview on 3/7/25 at 2:35 PM. The Agency failed to document any coordinated efforts among Agency staff members assigned towards the management with appropriate actions of a compliant infection control program.”

“Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This Standard is not met as evidenced by: Based on record review and interview, the Agency failed to ensure annual infection control education was provided to staff employed or contracted by the Agency in 4 (Clinical Manager/Staff B, Registered Nurse/Staff E, Occupational Therapy/Staff F, and Physical Therapy Assistant/Staff G) out of 9 personnel files reviewed for annual infection control in-services, out of a total sample of 9 personnel files reviewed, resulting in a lack of knowledge and training regarding current infection prevention/treatment practices in the home setting. Findings include: On 3/6/25, a request was submitted to the Agency’s Administrator/Staff A at 1040 AM. to review at minimum, the annual infection control in-services provided to Agency staff. Personnel files were submitted at 1:50 PM., and subsequent review found that 4 (Clinical Manager/Staff B, Registered Nurse/Staff E, Occupational Therapy/Staff F, and Physical Therapy Assistant/Staff G) of 9 personnel files reviewed had no documented evidence that infection control in-services had been provided in the last two years. During an interview on 3/7/25 at 2:35 PM., the above findings were reviewed and acknowledged by Staff A. The Agency failed to ensure annual infection control education was provided to all staff employed or contracted by the Agency and failed to adhere to its policy referenced below. Agency Policy: “Infection Control Program Requirements (undated) pg. 5 stated, “Employee education shall occur at the time of employment, within 30 days of when changes occur, and on an annual basis. Records of such training shall be maintained, in accordance with the organization’s policy for retention of records, but not less than 3 years.””

“Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure home health aides were assigned to a specific patient by the appropriate skilled professional in 1 (P-7) of 7 records reviewed, resulting in the potential for unmet care needs and poor patient outcomes. Findings include: **Policy titled “Home Health Aide: Assignment” (not dated) stated, “The need for home health aide services is determined during the assessment by the nurse or therapist. When the services are ordered by the physician, the designated Registered Nurse/Therapist will assign and orient the aide to the care plan.” P-7: This 71-year-old patient was admitted to this home care agency on 12/14/24 with the diagnoses of type II diabetes with neuropathy (nerve damage), hypertension (high blood pressure), and swelling of the right lower leg. During record review on 3/6/25, it was determined physical therapy was the only skilled service ordered for this patient. The physical therapist completed the comprehensive assessment on 12/14/24 and home health aide services were started on 12/16/24 for 1 time a week for 7 weeks. Upon further review of the record, it was determined a registered nurse (Staff D) completed the aide care plan. Skilled nursing was not ordered for this patient, and this clinician did not assess the patient to determine care needs. Additionally, the aide care plan was signed by Staff D on 12/18/24 – 2 days after the aide started care. Findings were reviewed with and acknowledged by the Administrator (Staff A), the Clinical Manager (Staff B), and the Intake Manager (Staff C) during an interview on 3/7/25 at 1:20 PM.”

“Skilled services furnished CFR(s): 484.105(f) Standard: Services furnished. Skilled nursing services and at least one other therapeutic service (physical therapy, speech-language pathology, or occupational therapy; medical social services; or home health aide services) are made available on a visiting basis, in a place of residence used as a patient’s home. An HHA must provide at least one of the services described in this subsection directly, but may provide the second service and additional services under arrangement with another agency or organization. This Standard is not met as evidenced by: Based on record review and interview, the Agency failed to ensure that at least one qualifying service was provided directly (W-2) by Agency employees, resulting in the potential for interruption in continuity of care and unmet care needs. Findings include: On 3/6/25 at 11:05 AM., a request was submitted to review contracted/1099 staff agreements with other staffing agencies. After review of the contracts submitted, the determination was made that the Agency failed to provide evidence that the Agency provided at least one of the services directly as required. In addition, Form CMS-1572 which was reviewed and signed by the Agency’s Administrator on 3/7/25, which documented the provision of all services (Skilled Nursing, Physical Therapy, Occupational Therapy, Speech Therapy, Social Worker, and Home Health Aide) were solely under arrangement (contract/1099) or a combination of direct hire (W-2) with contracted 1099’s. The above findings were reviewed with and acknowledged by the Administrator, Clinical Manager and Intake Manager during an interview on 3/7/25 at 2:47 PM. The Administrator noted the contracts would be updated within the week to reflect that Aide services would be chosen for its sole direct hire.”

“Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record contained completed assessments and visit notes for 1 (P-5) of 7 records reviewed, resulting in a lack of information for all agency staff caring for this patient. Findings include: P-5: This 98-year-old patient was admitted to this home care agency on 2/7/25 with the diagnoses of hypertensive chronic kidney disease and back pain. During record review on 3/5/25, it was noted a discharge visit for skilled nursing was scheduled on 2/25/25, however, the note was labeled as not started. During a joint home visit with the physical therapist on 3/6/25 at 3:00 PM, the patient was asked if she was still receiving skilled nursing services. The patient stated the nurse made her last visit the week before, so it was confirmed the visit was made. During an interview with the Administrator (Staff A), the Clinical Manager (Staff B), and the Intake Manager (Staff C) on 3/5/25 at 1:00 PM, the staff was asked about the agency expectation for completing documentation after a visit. Staff C stated the expectation was 48 hours after the visit. During another interview with Staff A, Staff B, and Staff C on 3/7/25 at 1:20 PM, Staff C was asked if the discharge visit was made to the patient as scheduled on 2/25/25. Staff C stated the visit was made; however, the nurse had been sick and did not complete her documentation. Staff A, Staff B, and Staff C acknowledged the findings at the time of interview.”

“Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient had the right to participate in, be informed about, and consent or refuse care in 1 (P-7) of 7 records reviewed, resulting in the potential for unmet care needs and poor patient outcomes. Findings include: P-7: This 71-year-old patient was admitted to this home care agency on 12/14/24 with the diagnoses of type II diabetes with neuropathy (nerve damage), hypertension (high blood pressure), and swelling of the right lower leg. During record review on 3/6/25, it was determined the referral (dated 12/3/24) requested services from physical therapy, occupational therapy, skilled nursing, and home health aide. According to the OASIS (Outcomes and Assessment Information Set) completed by the physical therapist at the comprehensive assessment on 12/14/24, the patient refused services from skilled nursing and occupational therapy. However, neither skilled nursing nor occupational therapy were marked as refused on the consent form the patient signed on 12/14/24. Additionally, when reviewing the unduplicated census for the last 12 months, it was determined 21 of 21 patients who had been referred for occupational therapy services over the last year were marked as “refused”. According to an interview with the Intake Manager (Staff C) on 3/6/25 at 2:00 PM, the agency has not used an occupational therapist for about 2 years. Also, an anonymous patient who was also marked as “refused” for occupational therapy services was called on 3/7/25 at 12:30 PM. During the call, the patient was asked if she had refused any services for home health that were ordered by the physician. The patient stated she did not refuse any services and was told she did not qualify for any other services besides the physical therapy she had received. Findings were reviewed with and acknowledged by the Administrator (Staff A), the Clinical Manager (Staff B), and the Intake Manager (Staff C) during an interview on 3/7/25 at 1:20 PM.”

“Contact info Federal/State-funded entities CFR(s): 484.50(c)(10)(i,ii,iii,iv,v) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: (i) Agency on Aging (ii) Center for Independent Living (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient was advised of the names, addresses, and telephone numbers of federally and state-funded entities that service the area where the patient resides. Findings include: **Policy titled “Admission Packet Policy” (not dated) stated, “The following contents will be included in the packet:…Contact information (name, address & phone number) Federal & State Assistance agencies: Area on Aging, Center for Independent Living, Protection & Advocacy Agency, Aging & Disability Resource Center, & Quality Improvement Organization…” During review of the agency’s admission packet on 3/5/25, it was noted it did not include names, addresses, and phone numbers for the local Agency on Aging, Center for Independent Living, Protection and Advocacy Agency, Aging and Disability Resource Center, and Quality Improvement Organization. Findings were reviewed with and acknowledged by the Administrator (Staff A), the Clinical Manager (Staff B), and the Intake Manager (Staff C) during an interview on 3/7/25 at 1:20 PM.”

“RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient’s return home, or on the physician or allowed practitioner - ordered start of care date. This Element is not met as evidenced by: Based on record review and interview, the agency filed to ensure the initial assessment visit was conducted within 48 hours of referral to determine the immediate care and support needs in 1 (P-6) of 7 records reviewed, resulting in the potential for unmet care needs and poor patient outcomes. Findings include: **Policy titled “Admission Policy” (not dated) stated, “Initial assessment Visit: A home visit is made by the RN or PT within 24-28 hours of the referral or according to the physician orders and patient/family wishes.” P-6: This 93-year-old patient was referred to this home care agency on 12/3/24 with the diagnoses of lumbar (low back) disc degeneration, low back pain, and hypertension (high blood pressure). During record review on 3/6/25, it was noted the referral to start home care services was dated 11/25/24. Additionally, it was stamped “RECEIVED” by the agency on 11/25/24. Upon further review of the record, it was determined the initial assessment visit was done by the physical therapist on 12/3/24 – 8 days after the referral. There was no documentation in the record regarding attempts to schedule the patient, missed visits, or a reason for the delay. There was also no documentation of communication with the physician or new orders to reflect a delay in the start of care. Findings were reviewed with and acknowledged by the Administrator (Staff A), the Clinical Manager (Staff B), and the Intake Manager (Staff C) during an interview on 3/7/25 at 1:20 PM.”

“5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient’s immediate needs, but no later than 5 calendar days after the start of care. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment was completed by all disciplines within 5 days of the start of care in 1 (P-5) of 7 records reviewed, resulting in the potential for unmet care needs. Findings include: **Policy titled “Comprehensive Client Assessment” (not dated) stated, “8. Assessments are prioritized based on client need. All clients will have the Comprehensive Client Assessment completed within five (5) days of the initial visit.” P-5: This 98-year-old patient was admitted to this home care agency on 2/7/25 with the diagnoses of hypertensive chronic kidney disease and back pain. During record review on 3/5/25, it was noted skilled nursing performed the initial assessment visit for the start of care on 2/7/25. Upon further review of the record, it was noted physical therapy did not perform their initial assessment until 2/14/25 – 7 days after the start of care. There was no documentation of the reason for the delay in care. Findings were reviewed with and acknowledged by the Administrator (Staff A), the Clinical Manager (Staff B), and the Intake Manager (Staff C) during an interview on 3/7/25 at 1:20 PM.”

“Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient’s status, and must include, at a minimum, the following information: (1) The patient’s current health, psychosocial, functional, and cognitive status; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment accurately reflected the patient’s current health status at the time of admission for 2 (P-4, 5) of 7 records reviewed, resulting in incomplete clinical information to aide in determining the needs of these patients to assist in developing the plan of care. Findings include: **Policy titled “Comprehensive Client Assessment” (not dated) stated, “2. The Comprehensive Assessment will include a review of all medications the client is using. This assessment will identify potential adverse effects and drug interactions, including ineffective therapy, significant side effects, significant drug interactions, duplicate drug therapy and non-compliance with therapy.” It also stated, “3. In addition to general health status/system assessment, the agency comprehensive assessment tool with OASIS will include:…o. Medications, adverse events/reaction, reconciliation and follow-up.” (OASIS = Outcome and Assessment Information Set) P-4: This 73-year-old patient was admitted to this home care agency on 5/8/24 with the diagnoses of type II diabetes and right knee osteoarthritis. During record review on 3/7/25, it was determined the OASIS indicated “No – No issues found during review.” Upon using the medication interaction feature on the electronic medical record system, it was noted there were 3 instances of duplicate drug therapies identified, as well as 4 drug to drug interactions with a “potential interaction risk”. P-5: This 98-year-old patient was admitted to this home care agency on 2/7/25 with the diagnoses of hypertensive chronic kidney disease and back pain. During record review on 3/5/25, it was determined the OASIS indicated “No – No issues found during review.” Upon using the medication interaction feature on the electronic medical record system, it was noted there was 1 instance of duplicate drug therapy identified, as well as 1 drug to drug interaction with a “potential interaction risk” and 1 drug to drug interaction with “intervention required.” During an interview on 3/7/25 at 1:20 PM, the Administrator (Staff A), the Clinical Manager (Staff B), and the Intake Manager (Staff C) were asked about the discrepancy in the record. Staff C stated the agency always sends the doctor a report with any interactions to review, however, acknowledged the information in the comprehensive is conflicting and does not show a clear picture of the patient’s status. Staff A, Staff B, and Staff C acknowledged the findings.”

“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 follow agency policy regarding reconciliation and management of high risk drugs in 1 (P-4) of 7 records reviewed, resulting in the potential for harmful medication interactions and poor patient outcomes. Findings include: **Policy titled “High Risk/High Alert Medications/Safety Measures” (not dated) stated, “5. The field staff will ensure the following protocols are followed for any patient on ORAL HYPOGLYCEMICS & INSULIN:… All patients that are diabetic will require blood glucose monitoring using their own machines and if they do not have a machine the agency will get physician order for a blood glucose monitoring machine and have arrangements made to have delivered. The field staff will teach on insulin/oral hypoglycemic agent/s: patient has someone double check insulin syringe for correct dosage and insulin, patient/caregiver does site rotation, patient caregiver understand hypo/hyperglycemia and what to do for each, teach regarding side effects and purpose, reporting, tracking and performing blood glucose monitoring on a regular basis and/or physician orders, check sliding scale for accuracy and changes every visit and verify with staff, take medications daily as ordered (dose and route), do not skip doses, report any missed medications or signs and symptoms of hypo/hyperglycemia to physician immediately, when to hold medications if blood sugar too low (parameters on OASIS or per physician) or what to do if taken too much insulin or if blood sugar too high, patients take medications in a well-lighted environment, verify labels are correct, and what to do if took wrong dose of medication…. The field staff will document teaching and materials given and patient response to oral hypoglycemic agents and insulin. Have patient or caregiver do return demonstration of insulin or setting the pen and document in field staff notes. To have the different types of insulin segregated and labeled in legible print in the refrigerator. If sliding scale ordered by physician, MUST be written out on the medication profile…” P-4: This 73-year-old patient was admitted to this home care agency on 5/8/24 with the diagnoses of type II diabetes and right knee osteoarthritis. During record review on 3/7/25, it was noted the patient was taking Jardiance Oral 10 milligrams at 1 time per day (oral hypoglycemic) and Lantus subcutaneous 100 units/milliliter at 10 units per day (insulin). Upon further review of the record, it was noted there was no documentation that the steps above occurred per agency policy. Findings were reviewed with and acknowledged by the Administrator (Staff A), the Clinical Manager (Staff B), and the Intake Manager (Staff C) during an interview on 3/7/25 at 1:20 PM.”

“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 observation, record review and interview, it was determined the Agency failed to ensure the Plan of Care (POC) included pertinent safety measures to protect individuals from injury, and failed to ensure skilled nursing (SN) goals on the POC were patient specific and measurable in 1 (P-2) 1 record reviewed with SN as the lone service provided, out of a total sample of 7 records reviewed; and failed to ensure the POC included interventions and goals for the primary diagnosis in 2 (P-4, 7) of 7 records reviewed, resulting in the potential for significant injury, and unidentified/unmet patient goals. Findings include: P-2: The patient was admitted on 3/4/25, with diagnoses that included congestive heart failure with hypertensive heart disease, chronic kidney disease, and dependence on supplemental oxygen (O2). On 3/6/25 during a joint home visit with SN, the surveyor observed an ash tray with several used cigarettes. P-2 was interviewed how often he smoked, followed by when he would typically use O2 (2-3 Liters/min supplied by an oxygen concentrator). P-2 replied, “I smoke pretty much every day and use my oxygen before bed on most nights.” Towards the end of the home visit, the surveyor and SN observed 5 used cigarettes next to the patient’s bed alongside the O2 concentrator (within 2 feet). No signage or posted warnings of the danger/risk involved when using oxygen and smoking together. Review of P-2’s POC found no evidence of educational warnings to the patient/others of the dangers incurred when mixing oxygen and smoking together. In addition, 17 of 17 SN goals were not written in measurable terms to track and trend progress made (or lack of). Examples include: “Patient will verbalize an understanding of energy concerning measures by 4/30/25; Patient will be independent with medication management by 4/30/25; and Patient will be free from injury during the certification period.” The above findings were reviewed with and acknowledged by the Administrator, Clinical Manager and Intake Manager during an interview on 3/7/25 at 3:02 PM. All three staff noted this did not meet Agency expectations or its policy referenced below. Agency Policy: “Care Plans” (undated) page 1 stated, “Each client will have a care plan on file that outlines care and services necessary to meet the patient specific needs... and the agency’s plan to respond to those needs. This plan is developed with the client and family as indicated and is based on services needed to achieve specific measurable goals.” P-4: This 73-year-old patient was admitted to this home care agency on 5/8/24 with the diagnoses of type II diabetes and right knee osteoarthritis. During record review on 3/7/25, it was determined that other than foot care, the plan of care failed to include goals or interventions to assess, monitor, or treat the patient’s primary diagnosis of type II diabetes. P-7: This 71-year-old patient was admitted to this home care agency on 12/14/24 with the diagnoses of type II diabetes with neuropathy (nerve damage), hypertension (high blood pressure), and swelling of the right lower leg. During record review on 3/7/25, it was determined that other than foot care, the plan of care failed to include goals or interventions to assess, monitor, or treat the patient’s primary diagnosis of type II diabetes. Findings were reviewed with and acknowledged by the Administrator (Staff A), the Clinical Manager (Staff B), and the Intake Manager (Staff C) during an interview on 3/7/25 at 1:20 PM.”

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element is not met as evidenced by: Based on record review and interview, the Agency failed to ensure services were provided only as ordered by the physician in 4 (P-3, 4, 5, 6) of 7 records reviewed, resulting in the potential to negatively affect all 9 patients currently serviced by the Agency. Findings include: P-3: This patient was admitted on 1/7/25, which included diagnoses of unspecified systolic (congestive) heart failure, heart disease, diabetes type-2, and muscle weakness. The Plan of Care (POC) ordered skilled nursing (SN) services 1W6 (once a week x 6 weeks), followed by an additional order on 2/2/25 which documented, “Change in SN frequency per (Physician/Staff H) request, SN to start seeing patient 2x (twice) a week for HTN (hypertension) monitoring, assessment and instructions on HTN management and adequate diet, SN frequency 2W2, 1W3 starting week of 2/2/25.” Further record review noted a physician/Staff H progress note dated 1/14/25 (2nd week after home care admission) that documented pertinent SN responsibilities which are as follow: “CC (Chief Complaint) Unexplained weight loss (finding)... During the visit (with P-3), a comprehensive review of his medications revealed significant challenges, (P-3) demonstrates considerable difficulty identifying his medications, even when prompted with the names on the bottles. Given his history of multiple admissions for medication toxicity, this lack of clarity is particularly concerning.” Under “Assessment and Plan” on the 1/14/25 progress note, the physician/Staff H documented, “(P-3’s) inability to manage his medications independently is alarming given his history of toxicity. Immediate intervention is required to prevent further complications. His daughter will assist with medication management starting tomorrow... Nurse to assist in teaching high fiber diet, monitor weight loss, bowel movement, assess abdominal pain and report to me (Staff H) findings.” On 3/6/25, additional review of P-2’s medical record revealed several significant concerns. First, SN (RN/Staff I) failed to comply with the visit frequency order by providing only one visit each week during the 2W2 period effective 2/2/25. Then RN/Staff I prematurely discharged the patient from SN services on 2/18/25 without an approved physician order. Second, RN/Staff I failed to document any assessment/findings in the medical record concerning how the indefinite medication management with the daughter and P-3 was going. Third, no actual weights for P-3 were obtained from admission through discharge and 0 of 19 SN goals failed to mention or acknowledge any of the Physicians/Staff H concerns above (1/14/25 progress note). The above findings were reviewed with and acknowledged by the Administrator, Clinical Manager and Intake Manager during an interview on 3/7/25 at 3:20 PM. P-4: This 73-year-old patient was admitted to this home care agency on 5/8/24 with the diagnoses of type II diabetes and right knee osteoarthritis. During record review on 3/7/25, it was noted the electronic medical record system contained an attachment labeled as the referral. Upon review of the attachment, it was determined it was a physician progress note dated 5/7/24 that included a note to set up home health care for physical therapy for her right leg, however, there was no evidence of an actual order from the physician to approve the start of physical therapy. During an interview on 3/7/25 at 1:20 PM, the Administrator (Staff A), the Clinical Manager (Staff B), and the Intake Manager (Staff C) were asked to provide evidence of a physician referral. Staff C stated there was no referral specifically for home care. Staff C stated the physicians sometimes just send office notes like this and it’s too hard to get them to send an actual referral. There was no evidence of a physician referral for home health services. Staff A, Staff B, and Staff C acknowledged the findings. P-5: This 98-year-old patient was admitted to this home care agency on 2/7/25 with the diagnoses of hypertensive chronic kidney disease and back pain. During record review on 3/5/25, it was noted the record contained an attachment titled “Face to Face – PHYSICIAN’S ORDERS AND PLAN OF CARE” dated 2/6/25. A box was checked next to “PT” and “Other”. Upon further review of record, it was noted a nurse did the initial assessment on 2/7/25. Skilled nursing was not indicated on the referral. During an interview on 3/7/25 at 1:20 PM, the Administrator (Staff A), the Clinical Manager (Staff B), and the Intake Manager (Staff C) were asked to provide evidence of a referral for skilled nursing. Staff C stated the physician checked the box for “other” and forgot to indicate it was for skilled nursing. Staff C was shown the referral form with a place for “SN” (skilled nursing) to be checked. Staff C stated the physicians often miss the box for skilled nursing and mark “other” instead, but acknowledged the service requested should be written on the referral next to “other” to indicate which service should be ordered. There was no referral for skilled nursing services. Staff B and C also acknowledged the findings at the time of interview. P-6: This 93-year-old patient was referred to this home care agency on 12/3/24 with the diagnoses of lumbar (low back) disc degeneration, low back pain, and hypertension (high blood pressure). During record review on 3/6/25, it was noted the referral to start home care (dated 11/25/24) ordered physical therapy. Physical therapy started care on 12/3/24. Upon further review of the record, it was also noted social work completed an evaluation on 12/9/24, however, there was no referral for social work noted in the record. Additionally, social work was not added to the plan of care to be approved by the physician. Upon further review of the record, it was noted the patient was admitted to the hospital on 12/13/24. An order was received by the agency on 12/17/24 to resume services (which would have been physical therapy only). According to the record, skilled nursing performed the comprehensive assessment for the resumption of care on 12/18/24, however, skilled nursing services were never ordered. Home health aide services were also added at this time. During an interview on 3/7/25 at 1:20 PM, the Administrator (Staff A), the Clinical Manager (Staff B), and the Intake Manager (Staff C) were asked to locate the order for the social work evaluation done on 12/9/24. Staff C confirmed there were no orders for a social work evaluation, and it was not on a signed plan of care that was approved by the physician. Staff C stated the clinician should have checked that before seeing the patient and wasn’t sure why she didn’t. Staff C was also asked for the orders for skilled nursing and home health aide to be added after the resumption of care. Staff C stated she was told a nurse was required to do the resumption of care following a hospitalization, so that’s why it was done without an order. Staff C did provide evidence of an order written to the doctor on 12/18/24 that included physical therapy, skilled nursing, and home health aide; however, this order was not signed by the doctor until 1/19/25, therefore, was not approved. Staff C also acknowledged there was no plan of care sent to the doctor following the resumption of care to approve the additional services. Findings were reviewed with and acknowledged by Staff A, Staff B, and Staff C at the time of interview.”

“Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient’s updated comprehensive assessment, and contain information concerning the patient’s progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure a revised plan of care was developed following a hospitalization and resumption of care in 1 (P-6) of 7 records reviewed, resulting in the potential for unmet care needs and poor patient outcomes. Findings include: **Policy titled “Care Plans” (not dated) stated, “2. The Care Plan shall be reviewed, evaluated, and revised (minimally every sixty (30)-(60) days and as needed) based upon the client’s health status and/or environment, ongoing client assessments, caregiver support systems, and the effectiveness of the interventions in achieving progress towards goals.” It also stated, “g. The plan of care will be revised at intervals, as necessary to continue to meet the needs of the patient.” **Policy titled “Client Reassessment/Update” (not dated) stated, “12. The discipline(s) MUST revise the POC to reflect the current information from the updated comprehensive assessment, record the patient’s progress toward meeting their specific goals and measurable outcomes, and notify the patient, representative, if applicable, caregiver, and the physician(s) when the plan of care is updated due to a SIGNIFICANT change in the patient’s health status-including discharge.” P-6: This 93-year-old patient was referred to this home care agency on 12/3/24 with the diagnoses of lumbar (low back) disc degeneration, low back pain, and hypertension (high blood pressure). During record review on 3/6/25, it was noted the patient resumed care with the agency on 12/18/24 following a hospitalization. It was also noted the patient had only been receiving services from physical therapy and social work prior to the hospital admission. Additionally, it was noted a nurse did the resumption of care assessment and home health aide services were also added. Upon further review of the record, it was noted there was no updated plan of care following the hospitalization to reflect the changes made to the plan of care after a significant change in status along with the addition of new services from skilled nursing and home health aide. Findings were reviewed with and acknowledged by the Administrator (Staff A), the Clinical Manager (Staff B), and the Intake Manager (Staff C) during an interview on 3/7/25 at 1:20 PM.”

“Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient and caregiver were provided with the name of the clinical manager, resulting in the patient being uninformed of who to contact at the agency with any concerns. Findings include: **Policy titled “Admission Packet Policy” (not dated) stated, “The following contents will be included in the packet:…Patient folder with agency name and phone number, Administrator name, phone number, and Clinical Manager/Supervisor name and phone number...” During review of the agency’s admission packet on 3/5/25, it was noted the name listed for the Clinical Manager did not match who was reported as the Clinical Manager during the entrance interview on 3/5/25 at 1:00 PM. The current Clinical Manager is Staff B and he was also present during the interview. During an interview with the Administrator (Staff A) on 3/5/25 at 2:00 PM, Staff A was asked about the person who was listed as the Clinical Manager in the admission packet. Staff A stated that was the previous Clinical Manager who now works as the Quality Control Manager (Staff D) in another state. During an interview with Staff A, Staff B, and the Intake Manager (Staff C) on 3/7/25 at 1:20 PM, Staff C stated new admission packets had been ordered with the correct information, however, she was not able to provide evidence of that. Staff A, Staff B, and Staff C acknowledged the findings at the time of interview.”

“Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This Element is not met as evidenced by: Based on record review and interview, the agency failed to adequately assess and monitor the needs of the patient in 2 (P-4, 7) of 7 records reviewed, resulting in the potential for poor patient outcomes. Findings include: P-4: This 73-year-old patient was admitted to this home care agency on 5/8/24 with the diagnoses of type II diabetes and right knee osteoarthritis. During record review on 3/7/25, it was noted the plan of care (dated 5/8/24) included blood sugar parameters to report to the physician of: “Fasting blood sugar greater than (>) 250 or less than () 300 or less than (Fasting blood sugar greater than (>) 250 or less than () 180 or less than () 5 lbs or less than ( Upon further review of the record, it was noted O2 saturation and blood sugar and were not reported by the physical therapist on the comprehensive assessment dated 12/12/24. It was also noted the comprehensive assessment stated, “pt doesn’t have glucometer at this time, grand son reported her uncle has it,he will have her grand daughter to go and pick it up from him.” [sic] Additionally, it was noted O2 saturation, blood sugar, and weight was not reported by the physical therapist for 8 of 8 daily visits dated between 12/17/24 and 1/24/25. The physical therapist failed to assess and monitor the vitals above and failed to assess and monitor the blood sugar of a patient with a primary diagnosis of diabetes. Findings were reviewed with and acknowledged by the Administrator (Staff A), the Clinical Manager (Staff B), and the Intake Manager (Staff C) during an interview on 3/7/25 at 1:20 PM.”

“Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record contained updated responses to interventions in 1 (P-7) of 7 records reviewed, resulting in an inaccurate and incomplete medical record. Findings include: **Policy titled “Clinical Record Entry” (not dated) stated, “1. Documentation in the clinical record is detailed and accurate and reflects the care or services provided.” P-7: This 71-year-old patient was admitted to this home care agency on 12/14/24 with the diagnoses of type II diabetes with neuropathy (nerve damage), hypertension (high blood pressure), and swelling of the right lower leg. During record review on 3/6/25, it was determined the assessment section on the physical therapy assistant notes dated 12/17/24, 12/20/24, 12/26/24, 12/28/24, and 1/3/25 all contained the following statement word for word: “pt practiced exs to ble’s and ue’s 1 set x 10 reps.with rest.in sitting.pt practiced t/r tr to bed to chair to toilet x 3.pt practiced tub tr x 1.pt practiced gait with inside the apt with 4ww with balancet tr. exs.pt also praceticed sit to stand x 3. pt also practiced HEP needs help in HEP.” [sic] It was also determined the assessment section on the physical therapy assistant notes dated 1/17/25 and 1/24/25 contained the following statement word for word: “pt practiced exs to ble’s and ue’s 1-2 set x 10 reps.with rest.in sitting.pt practiced t/r tr to bed to chair to toilet x 2.pt practiced gait with inside and out side the apt with 4ww with balancet tr. exs.pt also praceticed sit to stand/squat x 3. pt also practiced HEP needs help in HEP” [sic] The statements are copied word for word, therefore, are not an accurate, updated representation of the patient’s response to the interventions. Findings were reviewed with and acknowledged by the Administrator (Staff A), the Clinical Manager (Staff B), and the Intake Manager (Staff C) during an interview on 3/7/25 at 1:20 PM.”