Legacy Home Health Agency Inc.

“Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This Standard is not met as evidenced by: Based on record review and interview, the Agency failed to code and electronically transmit completed OASIS (Outcome and Assessment Information Set) assessments to the CMS (Center for Medicare and Medicaid) system within thirty days of completing the assessment of the beneficiary for 80 of 424 (18.87%) records submitted. This failure prevented the patient’s data from being made available to Center for Medicare and Medicaid (CMS) for analysis to identify agency performance levels in the provision of patient care. The findings included: Record review of IQIES “Home Health Error Summary by Agency” report for 04/01/2024 - 04/15/2025 generated from the CMS national data system during presurvey preparation on 04/15/25 revealed Agency had submitted and processed 424 assessments. The report also revealed the Agency had 80assessments with error -3330 indicating those records were submitted after the 30th date of the M0090 (assessment) date, which equaled to 18.87% of the total assessments submitted in error. In an interview with DON and Adm on 04/24/25 at 8:30 a.m., DON stated the manager was responsible for submitting OASIS information to CMS. DON and Adm did not dispute the errors and stated “yes”, they did have several late submissions for the past year. Surveyor asked why they had late submissions for their Oasis. DON stated, “The nurses are not submitting their Oasis in a timely manner.” Surveyor further asked how late Oasis submissions can affect patient care. DON further stated, “I can see where it could affect client care because it generates the plan of care. It can slow the documentation process. Adm confirmed there could be a possibility of affecting client care. In an interview with Manager on 04/24/25 at 9:17 a.m., confirmed that she was responsible for the transmission of the OASIS. Surveyor asked why they had late submissions for their Oasis. Manager confirmed that it is a process, and it can be late due to the clinician or the encoder. Record review of the Agency’s policy manual contained a policy titled, “IM.9 Timeliness”, with a date of 07/01/21, quoted in part, “Purpose: To establish timeframes for completion and incorporation of paperwork and OASIS into clinical record…Procedure…Oasis submission/export to CMS within 30 days of M0090 date. Record review of the Agency’s policy manual a policy titled, “IM.10 OASIS collecting, Encoding, and Transmitting”, with date of 01/01/21, quoted in part, “484.45 (a) Encoding and transmitting OASIS data. 1. The agency must encode and electronically transmit each completed OASIS assessment to the CMS system...within 30 days of completing the assessment of the beneficiary...The HHA will encode and transmit data using the software available from CMS or software that conforms to CMS standard…” The agency did not dispute the surveyor’s findings. The agency was afforded the opportunity to provide additional information. No additional information was presented to this surveyor upon exit on 04/24/25.”

“Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This Standard is not met as evidenced by: Based on record review, observation, and interview the agency failed to enforce its written policy addressing infection control including the prevention of the spread of infectious and communicable disease for 1 of 3 active Patients (Patient #3) reviewed for infection control in that: LVN A failed to follow proper procedures while conducting a home visit with patient #3: 1.) missed opportunities for glove changes. 2.) placed gentamicin 0.1% ointment onto posterior (refers to behind or back side of body or its parts) left hand of contaminated gloves. 3.) mixed collagen powder (stimulates new tissue growth by attracting fibroblasts [specialized cells that produce protein] to form on wound bed) with saline on the palm of contaminated gloves on her left hand. This deficient practice could place Patients at risk for increased wound infections, and further deterioration of the patient’s wounds. The findings included: Record review of [Agency Name] Policy and Procedure Compliance Manual titled “IC.1 Infection Control Program” with an revision date of 07/01/21, quoted in part,…Purpose: “To maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases…Policy: The agency and staff will follow accepted standards of practice…including standard precautions, to prevent the transmission of infections and communicable diseases…G. Home Health Agency policies and procedures address prevention and control activities, as well as strategies to minimize, reduce or eliminate the prioritized risks including…1. Standard precautions 2. Proper use and removal of PPE…4. Adherence to cleans and sterile procedures 5. CDC guidelines 6. Communicable Disease prevention and control Act…7. Current federal/state/local laws and regulations 8. OSHA bloodborne pathogens…15. Minimizing potential exposures 16. Procedures to prevent transmission of the pathogen to patients or staff…” Record review of [Agency Name] Policy and Procedure Compliance Manual titled “TX.1 Standards of Practice” with a revision date of 05/31/16, quoted in part, “Purpose: To provided patient care with acceptable standards of practice by Agency staff…The agency will provide patient care in accordance with professional employee’s State Practice Act for acceptable standards of practice, acceptable standards of care, and Agency’s policies and procedures…Procedures…C. Staff will be expected to follow all applicable standards of practice…including but not limited to, the following: 1. Federal Regulations for Medicare Home Health Agencies 2. Home Health Conditions of Participation 3. Standard State Licensing for Home Health Agencies…7. Agency Home Health Policy & Procedure Manual; and 8. Clinical Procedural Manual: Lippincott’s Nursing Procedure Manual…” Review of Patient #3 “Home Health certification and plan of care” documented a 88-year-old female with primary diagnosis of Pressure ulcer of right hip stage 4 (extensive tissue damage exposing underlying muscle, tendon, cartilage, or bone), gastronomy tube (a device that provides direct access to the stomach for supplemental feedings, hydration, or medication), Alzheimer’s disease (build-up of proteins in the brain, leading to cell death and brain shrinkage characterized by memory loss and cognitive decline), Dementia (general decline in cognitive abilities that affect a person’s ability to perform everyday activities), hyperlipidemia (high levels of fat in the blood), Major Depressive disorder (persistent low mood, loss of interest or pleasure in activities), Hypo-osmolality (low levels of electrolytes and fluids in the blood), hyponatremia (abnormally low sodium levels in the blood), history of falling, bed confinement, long-term use of anticoagulants (medication that prevents clots in the blood), Diabetes mellitus type II (high blood sugar, insulin resistance and lack of insulin), and history of disease of circulatory system (condition that affects the heart and blood vessels). The form also documented a start of care as 10/04/24 and a “current episode” or certification period as 04/02/2025-05/31/2025 with skilled nurse visits for twice a week for nine weeks and four as needed visits for drainage/leakage. Safety Measures: Standard precautions/Infection Control. Further review, “wound care orders” dated 04/14/25…use aseptic technique (prevent contamination from pathogens) when providing wound care: Wound 1-Right back hip; Use a 4x4 gauze and cleanse the wound with vashe (super-oxidized [passes an electrical charge through a solution of salt and water, contains a high concentration of oxygen] solution formulated to combat bacteria and facilitate wound healing) or dermal cleanser (antiseptic that helps reduce the risk of infection and prevent bacteria), then wet swab stick with cleanser and gently clean the tunneled/undermined (narrow channel or passageway extending from the wound’s surface into deeper tissue) area with care…Mix collagen powder (stimulates new tissue growth by attracting fibroblasts to form on wound bed) and saline to make a paste and pack into tunneled/undermined area using swab stick. Puracol dressing (promotes faster healing, fostering cell growth, and building of new proteins) is to be laid on top of the red tissue granulation (reddish connective tissue that forms on the surface of a wound when the wound is healing) …cover with gauze and borderform. Wound 6-Right posterior (refers to behind or back side of body or its parts) lower extremity: cleanse with dermal cleanser, apply Gentamicin (treats bacterial skin infections) 0.1% to wound, and cover with gauze, kerlix to secure. Review of personnel record for LVN A documented a “Mandatory In-Service Record” which revealed LVN A was provided with mandatory in-services and training content via the KnowBe4 training platform. LVN A reviewed and acknowledged that she read, understood, and agreed to comply with the information and literature provided on 08/14/23, 10/16/23, and 10/01/24 for Bloodborne Pathogens and Infection control. An observation was made of LVN A performing wound care to Wound #1 Right back hip and Wound #6 Right posterior lower extremity while performing a home visit to patient#3 on 04/23/25 at 11:00 a.m. Surveyor and LVN A arrived at patient#3’s home at 11:00 a.m. Brief introductions were made, and consent was signed by POA. LVN A and surveyor entered home and proceeded into patient #3’s bedroom. Patient #3 observed to be lying in a supine (lying faced upward) position. LVN A sanitized hands, placed barrier on the bed next to patient, placed bag on barrier, and removed supplies on clean barrier. LVN A Donned (puts on) new gloves. LVN A assessed heart, lungs, O2 saturations, and temperature. LVN A Grabs a cleansing wipe and cleaned all supplies. LVN A Placed wipes in trash bag. LVN A Doffed (takes off) gloves. LVN A Hand sanitized and replaced supplies into nursing bag. LVN A grabbed a barrier. Provider then removed cover the patient#3 and lifted the right leg. LVN A placed barrier under the right leg. Hand sanitizes. Dons’ new gloves. Puts a barrier on the bed and sets-up supplies for wound cares. LVN A removes soiled dressing to right posterior lower extremity and places dressing into to trash bag. Doffs gloves. Hand sanitizes. Dons’ new gloves. LVN A puts vashe on a 4x4 gauze and cleanses right posterior lower extremity wound. Pat dries with 4x4 gauze. Then proceeds to apply gentamicin ointment onto the top of her left contaminated glove, removes swab stick from wrapping, puts ointment on the swab stick from left contaminated glove, and applies gentamicin ointment to right posterior lower extremity wound with swab stick. LVN A then proceeds to apply 4x4 gauze, wraps leg with kerlix, and secures with tape. LVN A did not change gloves from going from contaminated site to clean site. (Missed opportunity for glove change). LVN A rolls up barrier and doffs gloves and places them in trash bag. Hand sanitizes. Dons’ new gloves. LVN A places barrier on the bed and places wound care supplies for right back hip. Provider turns patient to left side lying position. LVN A removes soiled dressing. Doffs gloves. Trash. Hand sanitizes. Dons’ new gloves. LVN A cleanses right back hip with Vashe using a 4x4 gauze. Throws gauze in trash. LVN A opens puracol package then proceeds to place collagen powder onto the palm of her left contaminated hand and mixes collagen powder with saline. Applies mixed collagen onto right back hip wound with swab stick, applies puracol, covers with 4x4 gauze, and covers with borderform dressing. LVN A did not change gloves from going from contaminated site to clean site. (Missed opportunity for glove change). Picks up barrier, removes gloves, and discards in trash bag. Hand sanitizes. Dons’ new gloves, helps provider reposition patient. Doffs gloves. Hand sanitizer. Throws trash bag in household trash can. In an interview on 04/23/25 at 11:45 a.m., with LVN A, surveyor presented the above findings during home visit for patient #3 which included the following: 1.) missed opportunities for glove changes. 2.) placed gentamicin 0.1% ointment onto contaminated gloves. 3.) mixed collagen powder with saline on the palm of contaminated gloves. LVN A agreed to these infection control findings concerning the transmission of diseases. LVN A confirmed employees are to use infection control precautions at every home visit. LVN A further confirmed she was trained upon hire and yearly for standard and infection control precautions by the agency. Surveyor asked if LVN A considered her gloves to be contaminated once a wound had been cleansed. LVN A stated, “Yes.” Surveyor further asked why she missed opportunities for glove changes while moving from a contaminated wound site to a clean wound site during wound care for the right back hip and right posterior lower extremity. LVN A stated, “I thought I was doing it the right way, it’s how I learned how to do it at school.” Surveyor asked why she placed gentamicin ointment and mixed collagen on her contaminated gloves. LVN A confirmed she just forgot the steps. Surveyor further asked considering the patient’s age, diagnosis, comorbidities (two or more medical conditions in a patient), artificial openings (creates a surgical opening from an area inside the body to the outside), and wounds how can these infection control findings concerning the transmission of diseases affect the patient. LVN A stated, “Possibility of infection and wound getting worse.” Further interview with Adm and DON/Alt Adm on 04/24/25 at 8:30 a.m., the surveyor presented the findings of infection control for home visit with patient #3. The Adm and DON/Alt Adm confirmed the agency provided trainings to their nurses for standard and infection control precautions upon hire and annually. Adm and DON/Alt Adm confirmed the agency’s infection control policy should be used at every home visit and agreed that the findings were an infection control issue concerning transmission of diseases. Surveyor asked considering the patient’s age, diagnosis, comorbidities, artificial openings, and wounds how can these infection control findings concerning transmission of disease affect the patient. DON/Alt Adm stated, “She very vulnerable to infection due to her age and status.” Adm further stated, “…They can get sick and end up in the hospital…” Review of Lippincott Advisor & Lippincott Procedures (evidence-based practice information) “Wound dressing application, home care” revision date 02/19/24 contains the following in part: Implementation: Perform hand hygiene… put on gloves…remove old dressing…inspect soiled dressing…discard dressing. Remove and discard soiled gloves. Perform hand hygiene. Put on new gloves. Assess wound. Clean the wound…Discard soiled gauze…remove and discard your soiled gloves. Perform hand hygiene. Put on new gloves…Apply topical wound treatments to wound bed using a cotton-tipped applicator…Apply dressing…secure dressing…remove and discard your gloves. Perform hand hygiene”. Review Lippincott Advisor & Lippincott Procedures (evidence-based practice information) “Standard precautions, home care” revised date 08/18/22 contains the following in part: “The Centers for Disease Control and Prevention (CDC) developed standard precautions to protect against the transmission of infection… Standard precautions include… appropriate use of personal protective equipment (PPE)...Wear gloves if you may or will come into contact with blood…body fluids… contaminated surfaces or objects…. Change your gloves and perform hand hygiene if your gloves become…soiled and when moving from a contaminated to a clean site during patient care to avoid cross-contamination. Avoid touching your face, body, and other surfaces and items not needed for direct patient care with your gloved hands to reduce the risk of transmitting infectious organisms” Review of OSHA 29 CFR 1910.1030 with a date of 11/03/23, contains the following in part: “Personal protective equipment… Gloves. Gloves shall be worn when it can be reasonably anticipated that the employee may have hand contact with blood, other potentially infectious materials, mucous membranes, and nonintact skin…and when handling or touching contaminated items or surfaces… (A) Disposable (single use) gloves such as surgical or examination gloves, shall be replaced as soon as practical when contaminated…” The agency did not dispute the surveyor’s findings. The agency was afforded the opportunity to provide additional information. No additional information was presented to this surveyor upon exit on 04/24/25.”

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element is not met as evidenced by: Based on record review, observation, and interview, the agency’s Supervising Nurse failed to ensure that treatments were performed only as ordered for 1 of 5 active patients (Patient #3) receiving licensed and certified services and whose clinical records were reviewed, in that: Patient #3 did not receive proper wound care treatment by LVN A to 1) right posterior (refers to behind or back side of body or its parts) lower extremity and 2) right back hip as ordered by a physician. This failure could place the patients at risk of not receiving the necessary care and services and a worsening of patient #3’s wounds. The findings included: Review of Patient #3 “Home Health certification and plan of care” documented a 88-year-old female with primary diagnosis of Pressure ulcer of right hip stage 4 (extensive tissue damage exposing underlying muscle, tendon, cartilage, or bone), gastronomy tube (a device that provides direct access to the stomach for supplemental feedings, hydration, or medication), Alzheimer’s disease (build-up of proteins in the brain, leading to cell death and brain shrinkage characterized by memory loss and cognitive decline), Dementia (general decline in cognitive abilities that affect a person’s ability to perform everyday activities), hyperlipidemia (high levels of fat in the blood), Major Depressive disorder (persistent low mood, loss of interest or pleasure in activities), Hypo-osmolality (low levels of electrolytes and fluids in the blood), hyponatremia (abnormally low sodium levels in the blood), history of falling, bed confinement, long-term use of anticoagulants (medication that prevents clots in the blood), Diabetes mellitus type II (high blood sugar, insulin resistance and lack of insulin), and history of disease of circulatory system (condition that affects the heart and blood vessels). The form also documented a start of care as 10/04/24 and a “current episode” or certification period as 04/02/2025-05/31/2025 with skilled nurse visits for twice a week for nine weeks and four as needed visits for drainage/leakage. Safety Measures: Standard precautions/Infection Control. Further review, “wound care orders” dated 04/14/25…use aseptic technique (prevent contamination from pathogens) when providing wound care: Wound 1-Right back hip; Use a 4x4 gauze and cleanse the wound with vashe (super-oxidized [passes an electrical charge through a solution of salt and water, contains a high concentration of oxygen] solution formulated to combat bacteria and facilitate wound healing) or dermal cleanser (antiseptic that helps reduce the risk of infection and prevent bacteria), then wet swab stick with cleanser and gently clean the tunneled/undermined (narrow channel or passageway extending from the wound’s surface into deeper tissue) area with care…Mix collagen powder (stimulates new tissue growth by attracting fibroblasts to form on wound bed) and saline to make a paste and pack into tunneled/undermined area using swab stick. Puracol dressing (promotes faster healing, fostering cell growth, and building of new proteins) is to be laid on top of the red tissue granulation (reddish connective tissue that forms on the surface of a wound when the wound is healing)…cover with gauze and borderform. Wound 6-Right posterior (refers to behind or back side of body or its parts) lower extremity: cleanse with dermal cleanser, apply Gentamicin (treats bacterial skin infections) 0.1% to wound, and cover with gauze, kerlix to secure. An observation was made of LVN A performing wound care to Right back hip and right posterior lower extremity while performing a home visit to patient#3 on 04/23/25 at 11:00 a.m.…LVN A removed soiled dressing and placed into to trash bag. Doffed gloves. Hand sanitized. Donned’ new gloves. LVN A puts vashe on a 4x4 gauze and cleansed right lower leg wound… Donned new gloves. LVN A cleansed right back hip with Vashe using a 4x4 gauze. Threw gauze in trash. LVN A opened puracol package then placed collagen powder on the palm of her left contaminated gloved hand and mixes in saline. Placed mixed collagen onto right back hip wound with swab stick, applied puracol, covered with 4x4 gauze, and covered with borderform dressing…Picks up barrier, removed gloves, and discarded in trash bag. Hand sanitized. In an interview with LVN A on 04/23/25 at 11:45 am, surveyor presented the above findings. LVN A confirmed she did not perform the correct wound care for patient #3 by using vashe to cleanse the right posterior lower extremity instead of following the correct order for a dermal cleanser. LVN A further confirmed she forgot to wet the swab with cleanser and clean the tunneling for the right back hip. Surveyor asked why she did not perform the correct wound care order. LVN A stated, “The family of the patient likes us to use Vashe to cleanse the wounds …” Surveyor further asked how could not following the plan of care or physician’s orders affect patient care. LVN A stated, “There could be the possibility of infection, and the wound can get worse.” During an interview on 04/24/25 at 8:30 a.m. conducted with DON/Supervising Nurse confirmed that she was responsible for ensuring that patient #3’s plan of care and any physician orders were followed. DON/Supervising Nurse further confirmed that the current order for patient #3’s right lower leg is to “cleanse with dermal cleanser” and the right hip wound care you must “wet swab stick with cleanser and gently clean the tunneled/undermined area”. Surveyor asked how could not following physician’s orders or the plan of care affect patients. DON/supervising nurse stated, “It could change the status of the wound, and it could worsen instead of getting better. Patients could be at risk of going to the hospital.” Review of the agency’s policy titles, “TX.5 Orders for care”, dated 01/01/21 revealed in part, “Purpose…to ensure patient care is provided in accordance with federal and state laws and regulations…Policy A. Agency will obtain orders and provide care in accordance with orders…” Review of the agency’s policy titled, “TX.6 Plan of Care” dated 07/01/21 revealed in part, “Purpose To develop an individualized Plan of Care which specifies the care and services necessary to meet the patient’s specific needs and according to state and federal regulations…Policy A. Each patient will receive a individualized written plan of care”. The agency did not dispute the surveyor’s findings. The agency was afforded the opportunity to provide additional information. No additional information was presented to this surveyor upon exit on 04/24/25.”