Legacy Home Health, Inc.

“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 interview and record review, the facility failed to ensure their Emergency Preparedness Plan was being implemented when three of 21 staff members were not knowledgeable about the facility’s designated alternate meeting location in case of emergencies. This failure has the potential for delay in the overall facility communication and coordination of services for 57 patients who received care from the facility. Findings: During an interview on May 20, 2025, at 11:35 AM, with Certified Home Health Aide (CHHA), in Patient 1’s home, CHAA stated she was aware the office parking lot was the primary emergency meeting location, but she was not aware of alternate emergency meeting location. During an interview on May 20, 2025, at 1:30 PM, with Licensed Vocational Nurse (LVN), in Patient 2’s home, LVN stated she did not know where the facility’s alternate meeting location was. LVN further stated she would probably go to Administrator’s (ADMIN) house. During an interview on May 20, 2025, at 4:45 PM, with Speech Therapist (ST), in Patient 3’s home, ST stated she did not know the facility’s alternate meeting location in case of emergencies. During an interview on May 21, 2025, at 4:15 PM, with the ADMIN, the ADMIN stated facility staff should know where the facility’s designated alternate meeting location was in case of emergencies. The ADMIN further stated that, “All staff should have been educated and in serviced on emergency preparedness, they should know the alternate meeting location was the home address of Clinical Nurse Manager (CNM)”. During a concurrent interview record review on May 21, 2025, at 4:25 PM, with the ADMIN, the ADMIN reviewed the facility’s undated policy and procedure titled (P&P), “Emergency Preparedness Plan”, which indicated, “PROCEDURES 1. All staff members will be orientated to the emergency preparedness plan and their associated responsibilities during orientation. Continuity of Operations-Alternate Office Location: In the event of damage, inaccessibility, or other circumstances that prevent regular use of the primary office, operations will continue from designated alternate location”. The ADMIN stated the agency staff did not follow the policy.”

“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 interview, and record review, the facility failed to ensure the performance improvement project (PIP- concentrated effort on a particular problem in one area of the facility or facility wide; involves gathering information systematically to clarify issues or problems and intervening for improvements) of their Quality Assessment and Performance Improvement (QAPI) Program was in progress or in development as per their policy and procedure. This failure resulted in the facility to have missed opportunities for the evaluation and improvement in care services in areas that the facility identifies as needing attention, which had the potential to affect 57 patients. Findings: During a concurrent interview and record review on May 22, 2025, at 11:30 AM, with the Clinical Nurse Manager (CNM), the CNM reviewed the QAPI meeting minutes from the first quarter of 2024 through fourth quarter of 2024. The CNM stated the facility did not have a performance improvement project in progress or in development. The CNM further stated the facility only had quality metrics which they collect data for and review on a quarterly basis. During further interview, the CNM stated the quality metrics discussed in QAPI every quarter were outcome of general chart audits, infection control reports, hand hygiene compliance reports, complaint and grievance reviews, medication error and hospitalizations. The CNM further stated the facility did not have any currently identified issues in the quality metrics. The CNM further stated the facility did not have any projects they were working on from the first quarter of 2024 to present During a concurrent interview and record review on May 22, 2025, at 1:45 PM, with the CNM, the CNM reviewed the facility’s policy and procedure (P&P) tiled, “Organizational Quality Assessment and Performance Improvement (QAPI) Program”, dated January 1, 2021, which indicated, “PURPOSE-The HHA develops, implements, evaluates and maintains an effective, ongoing, HHA-wide, data driven QAPI program. The HHA governing body must ensure that the program reflects the complexity of its organization and services. GOALS: The primary goals of the organizational QAPI program shall be to continually and systematically plan, design, measure, assess and improve performance of organization wide key functions and processes relative to patient care, treatment and services”. The CNM stated the facility did not follow the P&P.”

“Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This Standard is not met as evidenced by: Based on observation, interview, and record review, the facility failed to follow infection control guidelines when expired medical supplies were found on the medical supply room and were available for use. This failure had the potential to put the facility’s 57 patients at an increased risk of infection (the invasion and growth of germs like bacteria, viruses or fungi in the body, which can cause illness or damage to tissues) and other complications of infectious microorganism. Findings: During a facility tour on May 19, 2025, at 11:30 AM, in the conference room/medical supply room, with Registered Nurse/Office Staff (RN), the following medical supplies were found to be expired and were available for use: 1. Six pieces of [Brand Name] Urinary leg bag (small, urine drainage bag worn on the thigh or lower leg) with an expiration date of October 31, 2024. 2. Six pieces of [Brand Name] Intermittent Catheter (thin, flexible tube inserted into the bladder through the urethra to drain urine) Uncoated 16 Fr (“Fr stands for French,” and its unit of measurement for catheter sizes) with an expiration date of September 30, 2023. 3. Five pieces of [Brand Name] 16 Fr Foley catheter with an expiration date of September 30, 2023. 4. Two pieces of [Brand Name] Silicone Coated Latex Foley Catheter 20 Fr with an expiration date of January 10, 2019. 5. One piece of [Brand Name] Foley Insertion Tray with an expiration date of September 30, 2024. 6. Two pieces of StatLock (catheter stabilization device) with an expiration date of April 28, 2024. 7. Two pieces Nasal Oxygen Cannula with an expiration date of January 13, 2024. 8. Two pieces of IodoForm Packing Strip with an expiration date of January 1, 2024. 9. One box of (50 wipes) SKIN-PREP Protective Wipes with an expiration date of December 12, 2023. The RN verified that all the medical supplies were expired and should have been discarded. During a concurrent interview and record review on May 19, 2025, at 12:15 PM, with the Administrator (ADMIN), the ADMIN reviewed the facility’s policy and procedure (P&P) titled, “Infection Prevention and Control”, dated November 1, 2021, which indicated, “POLICY [name of facility]. Will implement measures to prevent and control the spread of infection. Prevention strategies will focus on educating the staff providing home care, the clients receiving services, and their families. PROCEDURES-1. An infection is controlled through prevention measures that discourage the spread of infection. 2. Prevention strategies for employees providing client care services are: a. Check all supplies for expiration dates”. The ADMIN stated the medical supplies should have been checked regularly and expired items should have been discarded. The ADMIN further stated the facility did not follow the infection prevention and 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 observation, interview, and record review, the facility failed to ensure patients clinical records were stored in locked, waterproof file cabinets in a designated clinical records room in accordance with the facility’s policies and procedure. This failure had potential for 210 patient’s clinical record information to be lost or be at risk of unauthorized use. Findings: During a concurrent observation and interview on May 19, 2025, at 11:40 AM, with the Registered Nurse (RN) and Office Staff (OS), in the medical record room, there were 210 patient’s medical records stored inside 10 cardboard boxes in the room. The RN and OS stated the agency kept the discharged patient’s medical records in the cardboard boxes to review the files. The RN stated, “While we review the patient’s medical files, the files are kept in cardboard boxes in the medical records room, not in metal cabinets”. During a concurrent interview and record review on May 19, 2025, at 4:10 PM, with Administrator (Admin) and Clinical Nurse Manager (CNM), the ADMIN and CNM reviewed policy and procedure (P&P) titled “SAFEGUARDING/RETRIEVAL OF CLINICAL RECORDS,’ dated November 2023, which indicated, “PROCEDURE: 1. All physical patient clinical/service records will be maintained in locked, waterproof file cabinets in a record room: C. The clinical/service record room will not be left unattended during working hours. D. If the room is left unattended during business hours, the door will be locked. E. Only authorized personnel will have access”. The Admin and CNM stated the agency did not follow the procedure.”

“Have a confidential clinical record CFR(s): 484.50(c)(6) Have a confidential clinical record. Access to or release of patient information and clinical records is permitted in accordance with 45 CFR parts 160 and 164. This Element is not met as evidenced by: Based on observation, interview, and record review, the facility failed to ensure personal health information were kept confidential when Certified Home Health Aide (CHHA) received and sent Patient 1’s clinical records using her personal cell phone. This failure resulted in Patient 1’s personal health information being put at risk by not keeping health records confidential, and using personal equipment not being monitored and secured by the agency. Findings: During a review of Patient 1’s face sheet (contains demographic and medical information), it indicated Patient 1 had a start of care date of August 11, 2024, with a recertification period (time frame during which a patient receives home health care services, generally lasting 60 days) of February 7, 2025, through April 7, 2025. Patient 1 had diagnoses of dementia (a group of symptoms affecting memory, thinking and social abilities), hypertension (high blood pressure) and hyperlipidemia (high levels of fat in the blood). During a home visit observation on May 20, 2025, at 11:35 AM, with CHHA, CHHA was reviewing Patient 1”s “Aide Care Plan” (detailed document that outlines the specific care and services a home health aide will provide to a client in their home) on her personal cell phone. During a subsequent interview with CHHA, on May 20, 2025, at 11:45 AM, CHHA confirmed she used her personal cell phone to send and receive Patient 1’s medical information to the facility’s main office. During an interview on May 21, 2025, at 3:50 PM, with the Administrator (ADMIN), the ADMIN stated the facility staff were only supposed to send patient information using the facility’s electronic application called [name of the software]. The ADMIN further stated facility staff should not be using their personal phones to send patient’s information to the facility’s cellular (cell) via text messages. During a concurrent interview and record review on May 21, 2025, at 4:10 PM, with the ADMIN, the ADMIN reviewed the facility’s undated P&P, titled, “Transmission Security”, which indicated, “To ensure the confidentiality, integrity and availability of electronic protected health care information (ePHI, technical security measures to guard against unauthorized access. …[name of facility] will take appropriate steps to implement security measures to protect the integrity of ePHI while it is being transmitted over electronic communications networks…Procedure… [name of facility] will use integrity controls to ensure that the value and state of its ePHI is maintained during transmission and that ePHI is protected against unauthorized alteration or destruction during transmission over electronic communication networks…3. Protected health information stored, whether intentionally or not, in a photocopier, facsimile and other devices is subject to the HIPAA Privacy and Security Rules…Encryption 1. When deemed necessary, encryption will be used to protect ePHI during transmission over electronic communications networks…”. The ADMIN stated the policy was not followed by the staff. During a review of the facility’s policy and procedure (P&P) titled, “Health Information Management Policy and Procedure Manual”, dated August 1, 2020, it indicated, “PUPOSE- To ensure the security and privacy of all patent’s medical records. [name of facility], will take appropriate steps to implement security measures to protect the integrity of ePHI [any individual identifiable health information held or transmitted by a covered entity or its business associate] while it is being transmitted over electronic communications”.”

“Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This Element is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure criminal background check was performed prior to hire or prior to working with patients for one of six sampled employee (Speech Therapist (ST)). This failure resulted in the agency to allow staff to have access to patients without first ensuring their (staff) background was clear of criminal history related to abuse, neglect, or mistreatment, and had the potential to place 57 patients at risk. Findings: During an observation on May 20, 2025, at 4:25 PM, at Patient 3’s home, ST arrived and provided in-home speech therapy (a healthcare profession that focuses on the assessment, diagnoses, and treatment of disorders related to speech, language, communication, and swallowing) services. During a record review of ST’s employee file on May 21, 2025, at 11:00AM, there was documented evidence to indicate a criminal background check was performed for ST prior to hire. During an interview on May 21, 2025, at 11:45 AM, with the Administrator (ADMIN), the ADMIN stated ST was a contracted staff member who worked for the agency through a contracted registry called [name of the contracted staffing registry] which provided staff to perform speech therapy. The ADMIN further stated the agency did not have documentation of a background check on file for ST. During an interview on May 21, 2025, at 3:45 PM, with the ADMIN, the ADMIN stated the importance of a background check was to ensure staff didn’t have any criminal history prior to working with patients and to ensure they were able to legally work in the United States. During a concurrent interview and record review on May 21, 2025, at 3:55 PM, with ADMIN, the admin reviewed the facility’s policy and procedure (P&P) titled, “CATEGORIES/QUALIFICATIONS OF PERSONNEL”, dated November 2023, which indicated, “POLICY 3. The organization will employ or contract only those individuals who have valid credentials as stipulated by the state and federal requirements. 4. Personnel qualifications include appropriate professional licensure, certification, and absence of a criminal background for those positions designated by law and regulation”. The ADMIN stated the agency did not follow the policy and procedure.”