Good Shepherd Home Health Services

“Condition of Participation: Patient rights. CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient’s rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This Condition is not met as evidenced by: Based on patient record review, policy review, document review, and interviews, the home health agency (HHA) failed to meet the Condition of Participation of Patient Rights. These deficient practices had the potential to affect all patients/caregivers who submitted grievances to the HHA and to place all agency patients visited by the alleged perpetrator of abuse in jeopardy of experiencing a serious adverse outcome. Findings include: 1. The HHA failed to ensure patients were free from verbal, mental, sexual, and physical abuse for one (Patient (P) 8) of one patient record reviewed for a grievance from a sample of four grievances reviewed for the period of 01/01/24 through 12/31/24. The HHA failed to investigate an allegation of abuse, protect patients while the investigation was conducted, and reported the allegation of abuse to the appropriate authorities. (Cross Reference: G430) 2. The HHA failed to implement action to prevent further potential violations, including retaliation, while an allegation of abuse was being investigated for one (Patient (P) 8) of one patient record reviewed for a grievance with an allegation of abuse from a sample of four grievances reviewed for the period of 01/01/24 through 12/31/24. The HHA failed to remove the alleged perpetrator (Registered Nurse (RN) 2) from direct patient care while the investigation of abuse occurred. (Cross Reference: G486) 3. The HHA failed to implement its grievance policy by failing to provide written notice to the patient/caregiver of the investigation and resolution of the grievance for four (Patient (P) 5, P6, P7, P8) of four grievances reviewed for the period of 01/01/24 through 12/31/24. (Cross Reference: G432) 4. The HHA failed to ensure grievances submitted by patients or caregivers were investigated for two (Patient (P) 5, P8) of four grievances reviewed for the period of 01/01/24 through 12/31/24. (Cross-Reference: G478)”

“Local, State, Tribal Collaboration Process CFR(s): 484.102(a)(4) §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.542(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. This Standard is not met as evidenced by: Based on record review and interview, the home health agency (HHA) failed to develop a process for cooperation and collaboration with Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency event. This deficient practice had the potential to affect all 156 HHA patients and staff in the event a disaster occurred. Findings include: Review of the agency’s emergency preparedness plan indicated the plan did not include contact information for Federal emergency preparedness officials to be used during a disaster or emergency event. During an interview on 03/27/25 at 10:00 AM with Administrator and Clinical Manager (CM) 1, Administrator confirmed the emergency preparedness manual did not include contact for Federal emergency preparedness officials.”

“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 home health agency (HHA) failed develop procedures to follow up with on-duty staff and patients to determine services that were needed in the event that there was an interruption in services during or due to an emergency and failure to develop a procedure to inform State and local officials of any on-duty staff or patients that they were unable to contact. This deficient practice had the potential to affect all 156 patients and staff in the event a disaster occurred. Findings include: Review of the agency’s emergency preparedness plan indicated the plan did not include procedures to follow up with on-duty staff and patients to determine services that were needed in the event that there was an interruption in services during or due to an emergency and failure to develop a procedure to inform State and local officials of any on-duty staff or patients that they were unable to contact. During an interview on 03/27/25 at 10:00 AM with Administrator and Clinical Manager (CM) 1, CM1 confirmed the agency had not developed procedures to follow up with on-duty staff and patients to determine services that were needed in the event that there was an interruption in services during or due to an emergency or a procedure to inform State and local officials of any on-duty staff or patients that they were unable to contact.”

“Policies/Procedures for Medical Documentation CFR(s): 484.102(b)(4) §403.748(b)(5), §416.54(b)(4), §418.113(b)(3), §441.184(b)(5), §460.84(b)(6), §482.15(b)(5), §483.73(b)(5), §483.475(b)(5), §484.102(b)(4), §485.68(b)(3), §485.542(b)(5), §485.625(b)(5), §485.727(b)(3), §485.920(b)(4), §486.360(b)(2), §491.12(b)(3), §494.62(b)(4). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(5) or (3),(4),(6)] A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records. *[For RNHCIs at §403.748(b) and REHs at §485.542(b):] Policies and procedures. (5) A system of care documentation that does the following: (i) Preserves patient information. (ii) Protects confidentiality of patient information. (iii) Secures and maintains the availability of records. *[For OPOs at §486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. This Standard is not met as evidenced by: Based on record review and interview, the home health agency (HHA) failed to develop a policy that addressed a system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records during a disaster. This deficient practice had the potential to affect all 156 patients and staff in the event a disaster occurred. Findings include: Review of the agency’s emergency preparedness plan indicated the plan did not include a policy that addressed a system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records during a disaster. During an interview on 03/27/25 at 10:00 AM with Administrator and Clinical Manager (CM) 1, CM1 confirmed the agency had not developed a policy that addressed a system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records during a disaster.”

“Emergency Officials Contact Information CFR(s): 484.102(c)(2) §403.748(c)(2), §416.54(c)(2), §418.113(c)(2), §441.184(c)(2), §460.84(c)(2), §482.15(c)(2), §483.73(c)(2), §483.475(c)(2), §484.102(c)(2), §485.68(c)(2), §485.542(c)(2), §485.625(c)(2), §485.727(c)(2), §485.920(c)(2), §486.360(c)(2), §491.12(c)(2), §494.62(c)(2). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This Standard is not met as evidenced by: Based on record review and interview, the home health agency (HHA) failed to ensure the HHA’s communication plan included contact information for Federal emergency preparedness officials. This deficient practice had the potential to affect all 156 HHA patients and staff in the event a disaster occurred. Findings include: Review of the agency’s emergency preparedness plan indicated the communication plan did not include contact information for Federal emergency preparedness officials. During an interview on 03/27/25 at 10:00 AM with Administrator and Clinical Manager (CM) 1, Administrator confirmed the emergency preparedness communication plan did not include contact information for Federal emergency preparedness officials.”

“Methods for Sharing Information CFR(s): 484.102(c)(4)-(5) §403.748(c)(4)-(6), §416.54(c)(4)-(6), §418.113(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §482.15(c)(4)-(6), §483.73(c)(4)-(6), §483.475(c)(4)-(6), §484.102(c)(4)-(5), §485.68(c)(4), §485.542(c)(4)-(6), §485.625(c)(4)-(6), §485.727(c)(4), §485.920(c)(4)-(6), §491.12(c)(4), §494.62(c)(4)-(6). [(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: (4) A method for sharing information and medical documentation for patients under the [facility’s] care, as necessary, with other health providers to maintain the continuity of care. (5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii). [This provision is not required for HHAs under §484.102(c), CORFs under §485.68(c)] (6) [(4) or (5)]A means of providing information about the general condition and location of patients under the [facility’s] care as permitted under 45 CFR 164.510(b)(4). *[For RNHCIs at §403.748(c):] (4) A method for sharing information and care documentation for patients under the RNHCI’s care, as necessary, with care providers to maintain the continuity of care, based on the written election statement made by the patient or his or her legal representative. *[For RHCs/FQHCs at §491.12(c):] (4) A means of providing information about the general condition and location of patients under the facility’s care as permitted under 45 CFR 164.510(b)(4). This Standard is not met as evidenced by: Based on record review and interview, the home health agency (HHA) failed to ensure the communication plan included a method for sharing information and medical documentation for patients under the HHA’s care with other health providers to maintain the continuity of care and the means of providing information about the general condition and location of patients under the agency’s care. This deficient practice had the potential to affect all 156 and staff in the event a disaster occurred. Findings include: Review of the agency’s emergency preparedness plan indicated the communication plan did not include a method for sharing information and medical documentation for patients under the HHA’s care with other health providers to maintain the continuity of care and the means of providing information about the general condition and location of patients under the agency’s care. During an interview on 03/27/25 at 10:00 AM with Administrator and Clinical Manager (CM) 1, CM1 confirmed the agency had not developed a method for sharing information and medical documentation for patients under the HHA’s care with other health providers to maintain the continuity of care and the means of providing information about the general condition and location of patients under the agency’s care.”

“Information on Occupancy/Needs CFR(s): 484.102(c)(6) §403.748(c)(7), §416.54(c)(7), §418.113(c)(7) §441.184(c)(7), §482.15(c)(7), §460.84(c)(7), §483.73(c)(7), §483.475(c)(7), §484.102(c)(6), §485.68(c)(5), §485.68(c)(5), §485.727(c)(5), §485.542(c)(7), §485.625(c)(7), §485.920(c)(7), §491.12(c)(5), §494.62(c)(7). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (7) [(5) or (6)] A means of providing information about the [facility’s] occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For ASCs at 416.54(c)]: (7) A means of providing information about the ASC’s needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For Inpatient Hospice at §418.113(c):] (7) A means of providing information about the hospice’s inpatient occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. This Standard is not met as evidenced by: Based on record review and interview, the home health agency (HHA) failed to develop a procedure for providing information about the HHA’s occupancy, needs, and its ability to assist the authority having jurisdiction, the Incident Command Center, or designee during a disaster. This deficient practice had the potential to affect all 156 patients and staff in the event a disaster occurred. Findings include: Review of the agency’s emergency preparedness plan indicated the plan did not include procedure for providing information about the HHA’s occupancy, needs, and its ability to assist the authority having jurisdiction, the Incident Command Center, or designee during a disaster. During an interview on 03/27/25 at 10:30 AM with Administrator and Clinical Manager (CM) 1, CM1 confirmed the agency had not developed a procedure for providing information about the HHA’s occupancy, needs, and its ability to assist the authority having jurisdiction, the Incident Command Center, or designee during a disaster.”

“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 interview, the home health agency (HHA) failed to ensure all staff received emergency preparedness training annually as required by the agency’s policy and failed to maintain documentation of all emergency preparedness training. This deficient practice had the potential to affect all 156 patients and staff in the event a disaster occurred. Findings include: Review of the agency’s emergency preparedness plan indicated the plan required all staff to receive emergency preparedness training annually. The agency did not provide documented evidence all staff members had received emergency preparedness training annually. During an interview on 03/27/25 at 11:00 AM with Administrator and Clinical Manager (CM) 1, CM1 stated in-services were provided on emergency preparedness, but not all staff attend. CM1 confirmed the agency did not have documentation indicating all HHA staff had received emergency preparedness annually after hire.”

“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 patient record review, policy review, and interview, the home health agency (HHA) failed to ensure each patient received the home health services that were written in an individualized plan of care which was established by a physician for three (Patient (P) 2, P14, P15) of 13 patients reviewed for notification of the physician of missed visits from a sample of 17 patients. This deficient practice had the potential to affect all patients receiving services from the HHA. Findings include: Review of the undated policy titled, “Clinical Documentation” indicated, “...Services not provided and the reason for the missed visits will be documented and reported to the physician/allowed non-physician practitioner...” 1. Review of P2’s “Home Health Certification and Plan of Care” for the certification period of 01/22/25 to 03/22/25 indicated the skilled nurse frequency of visits was one time a week for four weeks. Review of P2’s electronic medical record (EMR) indicated a skilled nurse visit was missed on 02/26/25, and there was no documentation P2’s physician was notified of the change in P2’s plan of care. During an interview on 03/25/25 at 2:30 PM, Clinical manager (CM) 1 stated P2’s EMR had no documentation P2’s physician was notified a nursing visit was missed on 02/26/25. 2. Review of P14’s “Home Health Certification and Plan of Care” for the certification period of 03/11/25 to 05/09/25 indicated the skilled nurse frequency of visits was one time a week for six weeks. Review of P14’s EMR indicated a skilled nurse visit was missed on 03/22/25 with no documentation P14’s physician was notified of the missed visit and a change in P14’s plan of care. During an interview on 03/26/25 at 4:37 PM, CM1 stated P14’s EMR had no documentation P14’s physician was notified of the missed skilled nurse visit on 03/22/25. 3. Review of P15’s “Home Health Certification and Plan of Care” for the certification period of 02/12/25 to 04/12/25 indicated the skilled nurse frequency of visits was two times a week for one week, then three times a week for three weeks, and then two times a week for five weeks. Review of P15’s EMR indicated the skilled nurse visit was missed on 02/22/25, 02/23/25, 02/25/25, 03/03/25, 03/07/25, and 03/09/25 with no documentation P15’s physician was notified of the missed visits and a change in P15’s plan of care. During an interview on 03/26/25 at 4:50 PM, CM1 stated P15’s EMR had no documentation P15’s physician was notified of the skilled nurse missed visits on 02/22/25, 02/23/25, 02/25/25, 03/03/25, 03/07/25, and 03/09/25.”

“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 document review, policy review, and interview, the home health agency (HHA) failed to have documentation of the reason quality improvement projects were undertaken and the measurable progress achieved on the projects. This deficient practice had the potential to prevent the HHA from undertaking opportunities for improvement in the quality of patient care. Findings include: Review of the undated “Quality Assessment & [and] Performance Improvement Program Evaluation 2024” indicated “...The agency’s QAPI [quality assessment performance improvement] Plan includes the policies and procedures related to: … 3. Identify and prioritize problems and opportunities for improvement. 4. Systematically analyze underlying causes of systemic problems and adverse events. 5. Develop corrective action or performance improvement activities...” Review of the HHA’s quality improvement project for 2023, which Clinical Manager (CM) 1 stated was a completed project, indicated the problem identified was high utilization rate of emergency department and hospitalizations. Review of the documentation indicated the hospitalization rate per the electronic medical record (EMR) was 21% for the first month of 2023. Review of the documentation indicated the expected outcome of the project was to decrease the number of episodes of hospitalization to 15% by 12 months. Interventions, barriers, and action were documented. Documentation of the one year[sic] summary indicated the project “was deemed to be ineffective in reducing hospitalization and emergency department utilization rate, as hospitalization rates continued to increase quarterly...” Documentation of the project indicated “DON [director of nurses]/Clinical Managers to continue to monitor quarterly hospitalization rates and to complete summary after 1st quarter of 2025 for reassessment of program...” There was no documentation presented by the DON or CM of a reassessment of hospitalization rates for January and February 2025. Review of the ongoing quality improvement project indicated the HHA was studying the reported fall and near fall incidents. Documentation indicated a tally of data was documented for the first, second, and third quarters of 2024. There was no data documented for the fourth quarter of 2024, no documentation of the reason the quality improvement project was undertaken, and the measurable progress achieved on the project was not consistently documented. During an interview on 03/27/25 at 11:36 AM, CM1 stated they chose the project on falls because there was a large number of incident reports for falls in 2023. During an interview on 03/27/25 at 12:09 PM, CM1 stated the project presented as a completed project was actually incomplete, because the reassessment of hospitalization rates for 2025 was not done as stated in the project plan. CM1 stated the fall project reason for selection and plan for data collection was not documented, and the measurement of progress was incomplete.”

“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 observations, policy review, and interviews, the home health agency (HHA) failed to ensure HHA infection control policies included specific procedures for disinfecting noncritical items and failed to ensure clinical staff used standard precautions to prevent the transmission of infections and communicable diseases as observed during two (Patient (P) 10, P11) of four home visits conducted on 03/26/25. These deficient practices had the potential to expose all patients receiving services and staff performing home visits to infections and communicable diseases. Findings include: Review of the undated policy titled “Cleaning and Disinfecting in the Home” indicated “... All equipment and environmental and working surfaces will be cleaned and disinfected after contact with blood or other potentially infectious materials...” There was no documentation of the procedure for using a barrier to place staff personal bags on furniture in the patient’s home and the specific product to use to disinfect the staff’s reusable equipment, such as blood pressure cuffs, thermometers, and pulse oximetry equipment. Review of the undated policy titled “Handwashing/Hand Hygiene” indicated “... Indications for handwashing and hand antisepsis: ... d. Between tasks on the same client. e. Before touching a wound. f. After removing gloves. g. After touching objects that are potentially contaminated... i. When hands are visibly soiled. j. After using the toilet, blowing the nose or covering a sneeze. k. After assisting client to use the bathroom... m. When hands are visibly dirty or contaminated with proteinaceous material or are visibly soiled with blood or other body fluids, wash hands with either a non-antimicrobial soap and water or an antimicrobial soap with water. n. If hands are not visibly soiled, use an alcohol-based hand rub for routinely decontaminating hands in all other clinical situations... o. Decontaminate hands before having direct contact with clients. before donning sterile gloves to insert urinary catheters, vascular catheters or other invasive devices that do not require surgical procedures. p. Decontaminate hands after contact with client’s intact skin, after contact with body fluids, excretions, non-intact skin and wound dressings. q. Decontaminate hands after contact with inanimate objects including equipment in the immediate vicinity of the client. r. Decontaminate hands after removing gloves...” 1. Observation on 03/26/25 at 10:50 AM during a home visit to observe home health aide (HHA) 1 perform services for P10 revealed HHA1 used alcohol wipes to clean the blood pressure cuff and pulse oximeter after use, placed the pulse oximeter in the case, and did not clean the pulse oximeter case before placing it in HHA1’s personal bag. 2. Observation on 03/26/25 at 12:15 PM during a home visit to observe Registered Nurse (RN) 1 perform services for P11 revealed RN1 placed RN1’s personal bag on the chair in P11’s home without placing a barrier between the chair and the personal bag. Observation revealed RN1 left to go to RN1’s car and returned with paper towels which RN1 placed under his/her personal bag as a barrier. Observation revealed RN1 donned gloves and used a scissor to remove a dressing from P11’s left great toe and placed the scissor on a folder on the table in P11’s home without disinfecting the scissor. RN1 wet a two-by-two gauze with Normal Saline (sodium chloride) and cleaned P11’s wound with the same gloves used to remove the old dressing. Observation revealed RN1 obtained an island dressing from RN1’s personal bag while wearing contaminated gloves, applied triple antibiotic ointment to the dressing, and applied the dressing to P11’s left great toe. Observation on 03/26/25 at 12:58 PM revealed RN1 removed his/her gloves, did not perform hand hygiene, and went to RN1’s car to obtain supplies. RN1 returned and began to wrap the dressing with Coban, stopped and donned gloves without performing hand hygiene upon RN1 returning from his/her car and wrapped the dressing with Coban. Observation revealed the scissor fell on the floor, and RN1 picked up the scissor from the floor and placed it RN1’s personal bag without disinfecting the scissor. There was no observation of RN1 disinfecting any equipment (blood pressure cuff, pulse oximeter) before returning the equipment to his/her personal bag. During an interview on 03/26/25 at 1:08 PM, RN1 confirmed the above-documented observations were breaches in infection control practice. During an interview on 03/26/27 at 3:10 PM with Administrator, CM1, and CM2, CM1 stated the infection control observations from the two home visits were breaches in infection control. CM1 confirmed the HHA policies did not address the use of a barrier between the staff’s personal bag and the patient’s furniture and the type of disinfectant to use to disinfect equipment. CM1 stated staff should be using Sani Wipes and not alcohol wipes to disinfect equipment, such as stethoscopes, blood pressure cuffs, thermometers, and pulse oximeters.”

“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 policy review, document review, and interview, the home health agency (HHA) failed to maintain an agency-wide program for the prevention, control, and investigation of infectious and communicable diseases. This deficient practice had the potential to affect all patients receiving HHA services and all staff potentially placing each at risk for infectious and communicable diseases. Findings include: Review of the undated policy titled “Infection Control Surveillance” indicated the agency “... will establish a continuous data monitoring and collecting system to detect infections or identify changes in infection trends. The three types of surveillance that may be used are: Total surveillance - all infections identified in clients and employees. Targeted surveillance - specific infections, populations, or procedures. Outbreak surveillance - specific infections or infection clusters within multiple individuals at the same time. The Agency will implement a process of identifying all infections in the client and/or employee population and evaluate effectiveness of current control measures or identify an action plan to improve incidence of infections...” Review of infection control data presented for review by Clinical Manager (CM) 1 indicated the list included the patient’s name, the insurance company, the diagnosis, the clinician, the source of infection, and the date the infection was reported. There was no documentation of an investigation performed for each infection listed. During an interview on 03/27/25 at 11:11 AM, CM1 stated they track and trend infections and report them to QAPI (quality assessment performance improvement). CM1 stated they do not investigate each infection and develop a plan of action when necessary.”

“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, policy review, and interview, the home health agency failed to provide infection control education to all staff annually in accordance with the HHA’s infection control training policy. This deficient practice had the potential to affect all 156 patients receiving HHA services and all staff. Findings include: Review of the undated policy titled “OSHA [Occupational Safety and Health Administration] Infection Control/Exposure Plan” indicated “... Employees will receive education and training during orientation and at least annually ...” Review of the “In-Service Attendance Record” indicated all staff had not signed the attendance record. During an interview on 03/27/25 at 11:31 AM, Clinical Manager (CM) 1 stated verbal training on infection control was done by the Director of Nursing or Clinical Manager and staff take a test on “Hazardous Materials.” CM1 stated the staff had in-services on infectious diseases and blood-borne pathogens annually. CM1 confirmed not all staff receive annual infection control training as required by the agency’s infection control policy.”

“Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This Standard is not met as evidenced by: Based on policy review, observation, and interview, the Home Health Agency (HHA) failed to monitor, manage, and maintain the equipment used to access the web-based electronic medical record (EMR). The use of staff-owned personal computers and cell phones to access the EMR had the potential to compromise personal patient information and could affect all patients currently receiving services from the HHA and all patients who have received past services. Findings include: Review of the undated agency policy titled, “Use of Personal Computers/Tablets in Accessing the Electric Health Records Software” indicated, “... This policy applies to all employees, contractors, consultants, temporaries, vendors and other workers at [name of HHA], including all personnel affiliated with third parties that uses or has access to the agency’s Electronic Medical Records (EMR) software/Electronic Health Records (EHR) ... Install a Privacy Protector Screen on the computer/tablet that you will be using to access the software (DSL) [Data Soft Logic] The computer/tablet should have a good anti-virus/internet security software installed. If using your personal computer/tablet, set your screen auto-lock time to 5 mins or less in your settings. If your browser asks you if you want to save your username and password, DO NOT click on YES or SAVE as this will let others have access to your account. If using a shared computer/tablet, save your work and log out from your DSL account every time you leave the computer/tablet. If the browser you used asks you if you want to save your username and password, DO NOT click on YES or SAVE as this will let others have access to your account. Do not access the software in a public establishment, I.E. [that is] coffee shops or libraries if you don’t have a Privacy Protector Screen installed. Do not leave notes of your username and passwords anywhere [sic] that other people can have access to it... Save your work frequently so you could log out of your account anytime when not using it. Change your passwords at least once a month especially when using a shared computer/tablet. Always logout of your account and close the browser you used if you think you will not be back to the computer in 5 mins or less ...” Review of the undated policy titled, “Use of Personal Smartphones in Taking Patient Wound Photos” indicated, “... Make sure that your phone is password or PIN [personal identification number] protected Upload the photo to the agency’s secure communication software (currently using Microsoft Teams) or to the Agency’s Health Records software by the end of the day. Do not share or text any patient photos to anyone. If a co-worker needs a photo, inform him/her that you will be uploading it shortly to Teams or DSL and will be available in either one of those programs. Delete the photo from your phone’s “Gallery” and “Trash” folders after uploading it to either Teams or DSL. If your phone has the “sync to cloud automatically” feature turned on, make sure to delete it on your cloud account “Gallery” and “Trash” folders. Make sure your social media accounts set on your phone are not set to upload all the new photos you took. If you are not comfortable in suing [sic] your personal smartphone in taking patient photos, make sure to request a digital camera from the agency...” Observations on 03/26/25 from 9:00 AM to 2:40 PM revealed Occupational Therapist (OT) 1, Certified Nursing Assistant (CNA) 1, Registered Nurse (RN) 1, and Physical Therapist (PT) 1 each conducted a home visit with a HHA patient and used a laptop to document during the visit and had the patient sign his/her name on the laptop. During an interview on 03/25/25 at 9:38 AM, Administrator stated the staff uses Data Soft Logic (DSL) for documentation. Administrator stated the agency does not provide laptops and cell phones to the field staff who make visits. Administrator stated the field clinicians (nurses, physical therapists, occupational therapists, speech therapists, aides, and social workers) use their personal cell phones and personal laptops for communication and documentation respectively. During an interview on 03/25/25/at 4:34 PM, Information Technology Manager (ITM) stated the agency orients staff at orientation on how to protect patient information when using personal computers and cell phones. ITM confirmed he/she has no means to monitor, manage, and maintain each clinician’s computer and cell phone to assure they were set up in accordance with the agency’s policy.”

“Be free from abuse CFR(s): 484.50(c)(2) Be free from verbal, mental, sexual, and physical abuse, including injuries of unknown source, neglect and misappropriation of property; This Element is not met as evidenced by: Based on record review, document review, personnel file review, and interviews, the home health agency (HHA) failed to ensure patients were free from verbal, mental, sexual, and physical abuse for one (Patient (P) 8) of one patient whose record was reviewed for a grievance from a sample of four grievances reviewed for the period of 01/01/24 through 12/31/24. The HHA failed to investigate an allegation of abuse, protect patients while the investigation was conducted, and reported the allegation of abuse to the appropriate authorities. This deficient practice had the potential to place all agency patients visited by the alleged perpetrator in jeopardy of experiencing a serious adverse outcome. Findings include: Review of P8’s “Home Health Certification and Plan of Care” indicated P8 was admitted on 10/03/24. Review of P8’s recertification period of 12/02/24 to 01/20/25 indicated P8’s diagnosis was non-pressure chronic ulcer with an effective date of 11/29/24. Review of a grievance received on 12/24/23 from a nurse practitioner (NP) at Company A indicated P8 reported “... that assigned [name of skilled nurse – Registered Nurse (RN) 2] had slid [his/her] hand down the patients gown. Per [name of NP], [he/she] was unsure if the patient has been compliant with taking [his/her] medications and referred patient to another psych specialist. Per NP patient has only said good things about all the clinicians in the past and now is making claims/complaints regarding multiple staff that sees him/her at home including [his/her] PCA [personal care attendant] that has seen him/her in about a year ...” Review of the grievance indicated Clinical Manager (CM) 1 received the grievance and assigned P8 to another skilled nurse. There was no documentation the allegation of abuse was reported to the authorities, a thorough investigation was conducted, and the alleged perpetrator was relieved of direct patient care until the investigation was completed. There was no documentation CM1 interviewed the alleged perpetrator, RN2 about the allegation of abuse. Review of the undated policy titled “Vulnerable Adult/Child Abuse and/or Neglect” indicated “... all staff members are mandated to report a. any knowledge of client abuse and/or neglect ... The Administrator shall: a. Report the suspected patient abuse and/or neglect to the authorities in accordance with relevant statute. B. Conduct further investigation as necessary. C. Send a copy of the completed report of the patient abuse and/or neglect. d. Keep the original copy of the report in a locked administrative file.” There was no documentation in the policy that the alleged perpetrator would be relieved of direct patient care until the investigation was completed. Review of the employee file of the alleged perpetrator RN2 indicated there was a letter of resignation from RN2 dated 02/28/25. During an interview on 03/27/25 at 3:35 PM with the Administrator, CM1, and CM2, CM1 stated CM1 spoke to the patient and reported it to the agency’s Vice-President of Operations. CM1 stated “[he/she] didn’t pull [name of alleged perpetrator – RN2] from other patients, because CM1 didn’t view this as an abuse based on what [he/she] and the NP discussed.” When CM1 was asked what investigation was done, CM1 had spoken with P8 and thought there was inconsistency to what the patient was saying. The Administrator stated the agency did not have a policy that specifically addressed how to handle allegations of abuse, such as who to report to and the need to remove the alleged perpetrator from direct patient care until the investigation was completed.”

“Make complaints to the HHA CFR(s): 484.50(c)(3) Make complaints to the HHA regarding treatment or care that is (or fails to be) furnished, and the lack of respect for property and/or person by anyone who is furnishing services on behalf of the HHA; This Element is not met as evidenced by: Based on policy review and interview, the home health agency (HHA) failed to implement its grievance policy by failing to provide written notice to the patient/caregiver of the investigation and resolution of the grievance for four (Patient (P) 5, P6, P7, P8) of four grievances reviewed for the period of 01/01/24 through 12/31/24. This deficient practice had the potential to affect all patients submitting grievances to the HHA. Findings include: Review of the undated policy titled; “Client/Family Complaint/Grievance Policy” indicated “... All persons with a grievance will receive a written notice of the investigators’ review which will include the name of the contact person, steps taken to investigate the grievance, the result of the process and the date of completion...” Review of the documentation of the grievances submitted by P5, P6, P7, and P8 indicated there was no documentation that each patient had received a written notice of the investigation that was conducted, the name of the contact person, the result of the grievance process, and the date of completion of the investigation. During an interview on 03/25/25 at 11:35 AM, Administrator confirmed thorough investigations were not documented for each grievance, and no response letters were sent to the patients who submitted grievances.”

“Investigate complaints made by patient CFR(s): 484.50(e)(1)(i) The HHA must— (i) Investigate complaints made by a patient, the patient’s representative (if any), and the patient’s caregivers and family, including, but not limited to, the following topics: (A) Treatment or care that is (or fails to be) furnished, is furnished inconsistently, or is furnished inappropriately; (B) Mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and/or misappropriation of patient property by anyone furnishing services on behalf of the HHA. This Element is not met as evidenced by: Based on policy review, document review, and interview, the home health agency (HHA) failed to ensure grievances submitted by patients or caregivers were investigated for two (Patient (P) 5, P8) of four grievances reviewed for the period of 01/01/24 through 12/31/24. This deficient practice had the potential to affect all patients/caregivers who submitted grievances to the HHA. Findings include: Review of the undated policy titled; “Client/Family Complaint/Grievance Policy” indicated “...The Agency must: a. Investigate complaints made by a client, the client’s representative (if any) and the client’s caregivers and family, including but not limited to the following topics: Treatment or care that is (or fails to be furnished, is furnished inconsistently, or is furnished inappropriately; and Mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and/or misappropriation of client property by anyone furnishing services on behalf of the agency b. Document both the existence of the complaint and the resolution of the complaint ...” Review of the grievance received from P5 on 01/25/2024 and from a caregiver of P8 on 12/23/24 indicated there was no documentation that an investigation occurred for each complaint/grievance submitted. During an interview on 03/25/25 at 11:35 AM, Administrator confirmed thorough investigations were not documented for the grievances received from P5 and P8’s caregiver.”

“Protect patient during investigation CFR(s): 484.50(e)(1)(iii) (iii) Take action to prevent further potential violations, including retaliation, while the complaint is being investigated. This Element is not met as evidenced by: Based on document review, personnel file review, and interviews, the home health agency (HHA) failed to implement action to prevent further potential violations, including retaliation, while an allegation of abuse was being investigated for one (Patient (P) 8) of one patient record reviewed for a grievance with an allegation of abuse from a sample of four grievances reviewed for the period of 01/01/24 through 12/31/24. The HHA failed to remove the alleged perpetrator (Registered Nurse (RN) 2) from direct patient care while the investigation of abuse occurred. This deficient practice had the potential to place all agency patients visited by the alleged perpetrator in jeopardy of experiencing a serious adverse outcome. Findings include: Review of P8’s “Home Health Certification and Plan of Care” indicated P8 was admitted on 10/03/24. Review of P8’s recertification period of 12/02/24 to 01/20/25 indicated P8’s diagnosis was non-pressure chronic ulcer with an effective date of 11/29/24. Review of a grievance received 12/24/23 from a nurse practitioner (NP) at Company A indicated P8 reported “...that assigned [name of skilled nurse – Registered Nurse (RN) 2] had slid [his/her] hand down the patients gown. Per [name of NP], [he/she] was unsure if the patent has been compliant with taking [his/her] medications and referred patient to another psych specialist. Per NP patient has only said good things about all the clinicians in the past and now is making claims/complaints regarding multiple staff that sees him/her at home including [his/her] PCA [personal care attendant] that has seen him/her in about a year...” Review of the grievance indicated Clinical Manager (CM) 1 received the grievance and assigned P8 to another skilled nurse. There was no documentation the alleged perpetrator was relieved of direct patient care until the investigation was completed. There was no documentation CM1 interviewed the alleged perpetrator, RN2, about the allegation of abuse. Review of the undated policy titled “Vulnerable Adult/Child Abuse and/or Neglect” indicated “...all staff members are mandated to report a. any knowledge of client abuse and/or neglect . . . The Administrator shall: a. Report the suspected patient abuse and/or neglect to the authorities in accordance with relevant statute. B. Conduct further investigation as necessary. C. Send a copy of the completed report of the patient abuse and/or neglect. d. Keep the original copy of the report in a locked administrative file.” There was no documentation in the policy the alleged perpetrator would be relieved of direct patient care until the investigation was completed. Review of the employee file of the alleged perpetrator RN2 indicated there was a letter of resignation from RN2 dated 02/28/25. During an interview on 03/27/25 at 3:35 PM with the Administrator, CM1, and CM2, CM1 stated CM1 spoke to the patient and reported it to the agency’s Vice-President of Operations. CM1 stated “[he/she] didn’t pull [name of alleged perpetrator – RN2] from other patients, because CM1 didn’t view this as an abuse based on what [he/she] and the NP discussed.” When CM1 was asked what investigation was done, CM1 had spoken with P8 and thought there was inconsistency to what the patient was saying. The Administrator stated the agency did not have a policy that specifically addressed how to handle allegations of abuse, such as who to report to and the need to remove the alleged perpetrator from direct patient care until the investigation was complete.”

“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 electronic medical record (EMR) reviews, policy review, and interview, the home health agency (HHA) failed to ensure a registered nurse (RN) conducted an initial assessment to determine the care and support needs of the patient and to determine eligibility for the Medicare home health benefit, including homebound status for Medicare patients, within 48 hours of referral or within 48 hours of the patient’s return from the hospital for three (Patient (P) 1, P12, P14) of 13 patient’s EMRs reviewed for initial assessment visit from a sample of 17 patients. This deficient practice had the potential to affect all patients referred to the HHA for admission. Findings include: Review of the undated policy titled; “Client Admission Process” indicated “...Each client referred to the agency shall be evaluated by a Registered Nurse/therapist to determine the immediate care and support needs of the client; and for Medicare clients, to determine eligibility for the Medicare home health benefit. The initial assessment will be completed within forty-eight (48) hours of referral or within forty-eight (48) hours of the client’s return home, or on the physician ordered/client requested start of care date...” 1. Review of P1’s “Orders for Home Health,” received from Home Health Company A, indicated the physician signed the referral orders on 01/17/25. Review of P1’s “Home Health Certification and Plan of Care” for the period of 01/24/25 to 03/24/25 indicated the start of care date (the date the initial assessment visit was made) was 01/24/25, seven days after the referral from the physician. There was no documentation of communication with or a physician’s order from P1’s physician related to a delay in providing the initial RN assessment. During an interview on 03/25/25 at 1:12 PM, Clinical Manager (CM) 1 stated Company A received P1’s referral from the physician that was signed by the physician on 01/17/25. CM1 stated Company A refers patients to the agency when Company A had an overflow of patients. CM1 confirmed P1’s physician was not notified the initial assessment would be seven days after the physician signed the referral and did not obtain an order to delay P1’s initial assessment. 2. Review of P12’s “Referral” indicated the nurse practitioner signed the referral orders on 02/22/25. Review of P12’s “Home Health Certification and Plan of Care” for the period of 02/25/25 to 04/25/25 indicated the start of care was 02/25/25, 72 hours after the referral from the nurse practitioner. There was no documentation of communication with or an order from P12’s nurse practitioner related to a delay in providing the initial RN assessment. During an interview on 03/26/25 at 4:13 PM, CM1 confirmed P12’s initial assessment was conducted 72 hours after the referral was received. CM1 confirmed P12’s EMR had no documentation P12’s nurse practitioner was informed of the delay in the initial assessment visit, and an order was not seen in P12’s EMR. 3. Review of P14’s “Orders for Home Health,” received from Home Health Company A, indicated the physician signed the referral orders on 03/06/25. Review of P14’s “Home Health Certification and Plan of Care” for the period of 03/11/25 to 05/09/25 indicated the start of care date was 03/11/25, five days after the referral from the physician. There was no documentation of communication with or a physician’s order from P14’s physician related to a delay in providing the initial RN assessment. During an interview on 03/26/25 at 4:37 PM, CM1 stated Company A received P14’s referral from the physician that was signed by the physician on 03/06/25. CM1 stated Company A refers patients to the agency when Company A had an overflow of patients. CM1 confirmed P14’s physician was not notified the initial assessment would be five days after the physician signed the referral and did not obtain an order to delay P14’s initial assessment.”

“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 patient record review, observation, policy review, and interview, the home health agency (HHA) failed to ensure services and treatment were administered only as ordered by the physician for one (Patient (P) 11) of four home visits observed and for three (P1, P9, P15) of 13 patient electronic medical records (EMR) reviewed for implementation of physician orders from a sample of 17 patients. This deficient practice had the potential to affect all patients receiving services from the HHA. Findings include: Review of the undated policy titled, “Physician/Allowed Non-Physician Practitioner (NPP) Orders” indicated “...All medications, treatments and services provided to clients must be ordered by a physician/allowed non-physician practitioner (NPP) [nurse practitioner]. The orders may be initiated via telephone or in writing and must be countersigned by the provider in a timely manner...” 1. Observation on 03/26/25 at 12:58 PM during home visit revealed Registered Nurse (RN) 1 performed wound care to P11’s left great toe. RN1 removed the dressing from P11’s left great toe while wearing gloves. Observation revealed RN1 wet a four inch by four-inch gauze with Normal Saline (solution containing 0.9% sodium chloride) while wearing the same gloves worn to remove the old dressing. Observation revealed RN1 then applied triple antibiotic ointment to a two-inch island dressing (non-adherent central gauze pad that provides absorption of light to moderate drainage, while the breathable adhesive border helps secure it in place. It consists of a soft, non-woven cloth coated with hypoallergenic acrylic adhesive, an absorbent central gauze pad as the wound contact layer, and two strips of release paper) and applied it to the left great toe while wearing contaminated gloves (same gloves used to remove old dressing). Observation revealed RN1 wrapped the left great toe island dressing with Coban (breathable, lightweight, and moisture resistant dressing that conforms to fit body contours and is used as an overwrap). Review of P11’s “Home Health Certification and Plan of Care” for the certification period of 03/12/25 to 05/10/25 indicated P11’s wound care to the left great toe was to cleanse with wound cleanser, pat dry gently, apply triple antibiotic ointment, cover with gauze, and wrap with Coban daily. During an interview on 03/26/25 at 3:10 PM, CM1 stated the observations of wound care for P11 during the home visit made by RN1 was not performed in accordance with P11’s physician orders. 2. Review of P1’s “Home Health Certification and Plan of Care” for the certification period of 01/24/25 to 03/24/25 indicated the skilled nursing orders were for a frequency of one time a week for one week, then two times a week for one week, and then one time a week for four weeks. Further review indicated physical therapy (PT) orders were to evaluate and treat to upgrade P1’s transfer, balance, coordination, and gait pattern to maximum optimum level of functioning and to treat for active and passive range of notion and strengthening exercises. Review of P1’s “Physical Therapy Assessment,” signed by the physical therapist on 01/27/25, indicated the frequency of PT visits was two times a week for three visits. Review of P1’s “Physical Therapy Functional Reassessment” note, signed by the physical therapist on 02/12/25, indicated documentation of “Please request 2w2 [two times a week for two weeks) for 4 visits starting on February17,2025.” There was no documentation of communication with P1’s physician approving the request and no physician orders to increase the frequency. Review of P1’s calendar of visits made indicated PT visits were made on 02/19/25, 02/21/25, 02/24/25, and 02/26/25 with no physician orders for the services provided. Review of P1’s calendar of visits made indicated the nurse made a nursing visit on 03/07/25 (the seventh week) to discharge P1 with no physician order for the visit. During an interview on 03/25/25 at 1:37 PM, Clinical Manager (CM) 1 stated the nurse made an extra visit 03/07/25 to discharge P1 and did not have a physician’s order for the visit. CM1 stated the PT reassessment note that had a request to increase the visit frequency was sent to the physician and had not returned signed yet as of the time of this interview. CM1 stated a phone call should have been made to obtain a physician’s order for the increased PT visits. 3. Review of P9’s “Home Health Certification and Plan of Care” for the certification period of 02/20/25 to 04/20/25 indicated P9’s diagnosis was amyotrophic lateral sclerosis. Review of P9’s “Occupational Therapy [OT] Evaluation” conducted on 02/24/25 indicated the OT frequency was two times a week for four weeks. Review of P9’s EMR indicated the occupational therapist made a visit on 03/26/25 and did not have a physician’s order for the visit. During an interview on 03/26/25 at 3:20 PM, CM1 stated the occupational therapist did not obtain a physician’s order for the visit made on 03/26/25. 4. Review of P15’s “Home Health Certification and Plan of Care” for the certification period of 02/12/25 to 04/12/25 indicated a primary diagnosis of Type 2 diabetes mellitus. Review of P15’s “Home Health Certification and Plan of Care” indicated P15 “...has generalized weakness, difficulty in walking, poor balance, unsteady feet, and is at risk, for falls and pressure injury development...” Review of P15’s “Physical Therapy Assessment” performed on 02/14/25 indicated a frequency of visits of one time a week for one week then two times a week for four weeks. Review of P15’s EMR indicated the physical therapist made a visit on 03/18/25 and 03/20/25 without a physician’s order for the two additional visits. During an interview on 03/26/25 at 4:50 PM, CM1 stated the physical therapist did not obtain an order for the two additional visits.”

“Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This Element is not met as evidenced by: Based on patient record review, policy review, and interview, the home health agency (HHA) failed to ensure staff who provided patient care were communicating with others involved in the patient’s care to assure patient concerns and patient progress toward the goals identified in the plan of care were communicated for continuity of care for four (Patient (P) 1, P2, P3, P10) of 10 patient records reviewed for continuity of care communication from a sample of 17 patients. This deficient practice had the potential to affect all patients receiving services from the HHA. Findings include: Review of the undated policy titled, “Communication with Limited English-Proficient Persons” indicated “...Documentation shall establish that effective interchange, reporting, and coordination of client care does occur...” 1. Review of P1’s electronic medical record (EMR) for the certification period of 01/24/25 to 03/24/25 indicated services and treatment were provided by skilled nurses, physical therapists (PT), occupational therapists (OT), speech therapists (ST), and home health aides. Review of P1’s EMR indicated there was no documentation of communication amongst the skilled nurses, PTs, OTs, STs, and aide to assure patient concerns and patient progress toward the goals identified in the plan of care were communicated for continuity of care. During an interview on 03/25/25 at 1:53 PM, Clinical Manager (CM) 1 stated P1’s EMR had no communication of coordination of care amongst the clinicians providing home health services. 2. Review of P2’s EMR for the certification period of 01/22/25 to 03/22/25 indicated services and treatment were provided by skilled nurses, PTs, and OTs. Review of P2’s EMR indicated there was no documentation of communication amongst the skilled nurses, PTs, and OTs to assure patient concerns and patient progress toward the goals identified in the plan of care were communicated for continuity of care. During an interview on 03/25/25 at 2:55 PM, CM1 stated P2’s EMR had no communication of coordination of care amongst the clinicians providing home health services. 3. Review of P2’s EMR for the certification period of 01/20/25 to 03/20/25 indicated services and treatment were provided by skilled nurses. Review of P3’s EMR indicated there was no documentation of communication by the nurse with the Clinical Manager to assure patient concerns and patient progress toward the goals identified in the plan of care were communicated for continuity of care. During an interview on 03/25/25 at 3:30 PM, CM1 stated P3’s EMR had no communication of coordination of care with the Clinical Manager throughout P3’s certification period. 4. Review of P10’s EMR for the certification period of 01/26/25 to 03/26/25 indicated services and treatment were provided by skilled nurses, PTs, and OTs. Review of P10’s EMR indicated there was no documentation of communication amongst the skilled nurses, PTs, and OTs to assure patient concerns and patient progress toward the goals identified in the plan of care were communicated for continuity of care. During an interview on 03/26/25 at 3:54 PM, CM1 stated P10’s EMR had no communication of coordination of care amongst the clinicians providing home health services.”

“Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This Element is not met as evidenced by: Based on observation, patient record review, policy review, and interview, the home health agency (HHA) failed to ensure each patient and/or caregiver were provided with a copy of written instructions of medications (medication profile) that was kept current with medications in the home for one (Patient (P) 10) of two medication profiles reviewed during four home visits on 03/26/25. This deficient practice had the potential to affect all patients receiving services by the HHA. Findings include: Review of the undated policy titled; “Clinical Record Content/Medical Record Retention” indicated “...the clinical record shall contain appropriate identifying information, including, but not limited to: ...Medication Profile...” Review of the undated policy titled; “Medication Profile” indicated “...The Registered Nurse or Therapist will complete a medication profile for each client at the time of admission. The medication profile shall include all prescription and nonprescription drugs, including regularly scheduled medications and those taken intermittently or as needed. The profile will be reviewed and updated as needed to reflect current medications the client is taking ... If the physician/allowed non-physician practitioner (NPP) changes the medication orders, the Nurse must add newly ordered drugs or medication changes to the Medication Profile. Discontinued medications shall be highlighted and documented as “DC” with the appropriate date...The Medication Profile shall be reviewed by a Registered Nurse every sixty (60) days and updated whenever there is a change or discontinuation in medication. The Registered Nurse shall sign and date the Medication Profile upon initiation and, at minimum, every sixty (60) days thereafter...” Observation during a home visit with the home health aide on 03/26/25 at 10:50 AM revealed a large plastic bin filled with pill bottles. Observation revealed there were numerous bottles of the same medication in the bin. Observation revealed the following medications listed on P10’s “Medication Profile” for the certification period of 01/26/25 to 03/26/25 were not in the bin: Fluoxetine (Prozac - treats mental health conditions including depression and obsessive compulsive disorder) 20 mg (milligram) one capsule by mouth daily; Clonidine (Catapres - relaxes blood vessels and decreases blood pressure and the amount of work the heart has to do) 0.2mg/24hour patch, apply one patch to skin every week; Cyclobenzaprine (Flexeril – used to help relax certain muscles in the body. It helps relieve pain, stiffness, and discomfort caused by strains, sprains, or injuries to the muscles) 5 mg one tablet by mouth two times a day as needed for muscle spasm; Indomethacin (prescription nonsteroidal anti-inflammatory drug that reduces inflammation and relieves pain) 50 mg capsule three times a day as needed; Meloxicam (Mobic - nonsteroidal anti-inflammatory drug used to treat pain and inflammation in rheumatic diseases and osteoarthritis) 7.5 mg one tablet by mouth daily; and Pantoprazole (Protonix - treats conditions that cause too much stomach acid, like heartburn, stomach ulcers and reflux disease. It reduces the amount of acid in the stomach) 30mg one tablet by mouth daily. Observation during the visit revealed the following medications were in the bin but not listed on the medication profile: Sitagliptin (Januvia - a once-daily prescription pill that, along with diet and exercise, helps lower blood sugar levels in adults with type 2 diabetes) 100 mg tablets – had three bottles; Trazadone (a medication that treats depression. It works by increasing the amount of serotonin in the brain)100 mg tablet, one at bedtime; Clopidogrel Bisulfate (Plavix - an antiplatelet drug one can take to prevent blood clots) 75 mg tablet once daily; Calcium 500 mg one twice a day; Magnesium oxide (an antacid to relieve heartburn, sour stomach, or acid indigestion. Magnesium oxide also may be used as a laxative for short-term, rapid emptying of the bowel) 420 mg tablet once a day; Glipizide (lowers blood sugar by causing the release of the body’s natural insulin) 10 mg tablet twice a day; and Alogliptin (a medication that treats Type 2 diabetes) 25 mg once a day. During an interview on 03/26 25 at 3:10 PM with Administrator, Clinical Manager (CM) 1, and CM2, CM1 stated the patient’s medication profile was supposed to be updated when medication orders were changed, and the nurse should review medications during home visits.”