Royal Majesty Home Care, Inc.

“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 registered nurse (RN1) failed to perform hand hygiene (wash hands) in between direct contact with contaminated materials while providing wound care for one of 10 patients (Patient 20). This deficient practice placed the patient at a potential risk in the cross contamination and spread of infection. A review of Patient 20’s admission record indicated Patient 20 was admitted to the facility on 1/17/24, with diagnoses that included unspecified left lower leg open wound. A review of Patient 20’s plan of care (POC) from 3/17/24 to 5/15/24, included a SN (skilled nurse) frequency visit of daily for 21 days, to observe/assess all body systems focusing on integumentary (skin) system. One of the SN interventions was to provide wound care at left posterior lower leg venous stasis wound as follows: to cleanse with Normal Saline, pat dry, apply Medi-honey, then cover with Adaptic dressing, apply abdominal wrap with Kerlix then secure with Ace bandage daily. On 4/20/2024, at 1 p.m., a home visit was conducted at Patient 20’s residence with RN 1. The patient was observed lying on her back while RN 1 was providing wound care at left lower leg venous stasis open wound. RN 1 was observed initially washing her hands, then putting on a new pair of gloves, picked up a clean pair of gauze, wet the gauze with normal saline and wiped the open wound with it. She then threw the soiled gauze in the trash. RN 2 then picked up a new pair of gauze, wet it with normal saline and wiped and cleaned the open wound again with the same soiled gloves. RN 2 removed her soiled gloves, then donned a new pair of gloves without washing her hands. RN 1 measured the open wound, then started cleaning the open wound and sole of foot with wet gauze. RN 1 removed her soiled gloves and donned a new pair of clean gloves without washing her hands, then applied Medi-honey on the open wound, covered with Adaptic dressing and wrapped with Kerlix dressing. On 4/20/2024, at 1:45 p.m., during an interview with RN 1, she stated she forgot to wash her hands in between dressing changes because she got too nervous doing the procedure. On 4/21/2024, at 12:45 p.m., during an interview with the Director of Patient Care Services (DPCS), she stated, RN 1 should change her gloves and wash her hands as per the agency’s policy. A review of the agency’s undated policy titled “Hand Hygiene and Compliance Program (undated)”, indicated that staff should perform hand hygiene (wash hands) before and after direct patient care, when hands are soiled and after any contact with contaminated materials.”

“Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This Element is not met as evidenced by: Based on interview and record review, the HHA (home health agency) failed to ensure patient has the right to be informed of any changes in the care to be provided for one out of ten sample patients (Patient 24). This deficient practice had the potential for the patient’s care needs will not be provided and could affect the quality of care and wellbeing of the patient. On 4/20/2024 during a review of Patient 24’s electronic medical record (EMR-are a digital version of the paper charts in the clinician’s office) included a face sheet and the referral from the insurance. There was no signed plan of care (POC) by the physician or CMS 485-the Home Health Certification and Plan of Care- meet regulatory and national survey requirements for the physician’s plan of care, certification and re-certification, and no consents signed by the patient or responsible party. During a review of Patient 24’s EMR on 4/21/2024 at 11:30 a.m., revealed that the patient was referred to the HHA for physical therapy (PT- the treatment of disease or injury with physical techniques such as exercise, cold and heat treatments, massage, and stretching) evaluation dated 4/12/2024 due to diagnosis knee arthroplasty. A review of the EMR indicated a missed visit report dated 4/15/2024 due to Patient 24’s requested to hold PT until she sees her doctor on 4/23/2024, adjustment of frequency: Hold OT visits until further notice. Will call patient after her MD visit on 4/23/2024. During an interview with the Director of Patient Care Services Designee on 4/21/2024 at 11:30 a.m., DPCSD stated that Patient 24 was considered a non-admit patient. DPCSD further stated that when the agency staff received a referral, the patient’s name will be put in the system and plot the actual certification period when the patient will be admitted. During a concurrent interview with the Director of Patient Care Services (DPCS) on 4/21/2024 at 2 p.m., DPCS stated that any referrals are placed in the system and the system recognizes it as an active patient. DPCS stated that the MD was notified of the patient’s request. There was no documented evidence Patient 24 was informed of the new PT provision of the services. A phone interview with the medical insurance group representative on 4/22/2024 at 11 a.m., the representative stated that she was unable to see the initial referral but has another pending PT referral for the same patient to be sent by 4/25/2024 to the same agency for PT services. A review of the HHA’s undated policy titled “Admission Criteria and Process” indicated A nurse or therapist will attempt to make a first contact prior to the patient’s hospital discharge, if possible or appropriate. The initial home visit will be made within 48 hours after the patient’s discharge from a facility or as ordered by the physician (or another authorized licensed independent practitioner). During the initial visit, the admitting clinician will review the accuracy of patient identification with at least two (2) identifiers, the patient’s eligibility for home health services, according to the admission criteria to determine or confirm. The patient and/or family caregiver, after review, will be given the opportunity to either accept or refuse service. The patient or his/her representative will sign the required forms indicating acceptance of services and receipt o patient rights and privacy information. Refusal of services will b documented in the clinical record. Notification of the Clinical Supervisor, physician, a d referral source will follow with appropriate documentation in the clinical record. The admitting clinician wiII contact the physician for clarification, acceptance, or rejection of care.”

“Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. This Element is not met as evidenced by: Based on observation, interview and record review, the Home Health Agency (HHA) failed to ensure the nursing staff provided instructions or health teaching for management of edema and wound care to the patient’s caregiver (PCG) to one of 10 sample patients (Patient 26). This deficient practice has the potential in putting the patient at risk to develop infection and increased swelling that could affect the patient clinical status and well-being. A review of Patient 26’s Patient Profile Information indicated, a start of care (SOC) date of 2/12/2024, with a certification period of 4/12/2024 to 6/10/2024. Patient 26’s diagnoses included unspecified open wound on right lower leg (a type of injury that causes an external or internal break in the body’s tissue) and hematemesis (vomiting of blood). The re-certification POC included for a comprehensive skilled nursing assessment, observation and evaluation of cardiovascular, musculoskeletal, respiratory, neurosensory, pain, gastrointestinal, mental/emotional genito-urinary, status and integumentary, compliance to endocrine, medication and diet. Skilled nurse (SN) visits daily for 9 weeks to reassess vital signs, oxygen saturation as needed, self-care tasks, and assessment and evaluation of all bodily functional limitations. SN to perform wound care to multiple open wounds at right lower extremities: Cleanse with normal saline (NS), pat dry and apply SSD cream (silver sulfadiazine cream-to prevent and treat wound infections in patients with second- and third-degree burns) to wound bed, cover with Adaptec (a perforated gauze with treated with Vaseline) cover with ABD pad and wrap with kerlix followed by ace wrap. Wound on right forearm, cleanse with NS, pat dry and apply Vaseline ointment and cover with bandage. Record review also indicated the patient has edema (swelling) to both lower extremities. A home visit was conducted on 4/20/2024 at 11:30 a.m., with the visiting nurse 2 (VN 2). Patient 26 was observed sitting in the dining area on her wheelchair, alert and oriented to name person, denied pain and was not in any respiratory distress. The PCG was present during the visit. During an interview with Patient 26’s caregiver on 4/20/2024 at 11:30 a.m., PCG was asked if she received instructions on how to re-enforce the wound dressing in case of dislodgement or soiling and further asked regarding care instructions of the patient’s edema (swelling) to both lower extremities. PCG responded she did not know how to re-enforce the dressing; however, she was told to just cover it with Band-Aid, and also stated she was not given instructions on how to care for edema to both legs. Record review indicated no documented evidence the SN gave the PCG care instructions on wound care and edema management. During an interview with the Visiting nurse 2 (VN2) on 4/20/2024 at 12:30 p.m., VN 2 stated the visit was on a daily basis to perform the wound care. During an interview with the Director of Patient Care Services Designee (DPCSD) on 4/21/2024 at 11:30 a.m., DPCSD stated that caregiver teaching was important throughout the certification period for continuity of care. A review of the HHA’s document titled “ Patient Education Process” indicated Patients and family/caregiver will receive education in verbal, visual, and written format, as appropriate. The scope of teaching will be determined by assessing the needs, abilities, learning preferences, and readiness to learn of the patient and family/caregiver, as well as by the plan of care. Education wiII be the responsibility of each clinician and will focus on: Facilitating the patient’s and family/caregiver’s understanding of his/her health status, health care options, and consequences of options, Increasing patient and family/caregiver potential to follow the plan of care, Maximizing care skills of the patient and family/caregiver, Increasing the patient’s and family/caregiver’s ability to cope with the health status, prognosis and outcomes and Enhancing the patient’s a d family/caregiver’s role in continuing care.”

“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 interview and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation (conditions that health care organizations must meet in order to begin and continue participating in the Medicare [a federal health insurance for people 65 or older, and some people under 65 with certain disabilities or conditions] program) regarding Patient Rights was met as follows: 1. Based on interview and record review, the HHA failed to ensure that one of 17 patients (Patient 7) had their Patient Admission Folder (a folder given to patients at the start of care and consisted of important information for the patients to reference regarding their care) in their home. (Refer to G 410). 2. Based on observation, interview, and record review, the facility failed to advice two of 17 patients (Patients 13 and 14) the toll-free home health telephone hot line to its purpose, lodge complaints, and other concerns regarding care services furnished by the agency. (Refer to G444). 3. Based on interview and record review, the home health agency failed to conduct an complaint investigation regarding an alleged neglect (an act or failure to act which presents an imminent risk of serious harm) by a Registered Nurse 1 (RN 1) while doing patient care for one out of 17 sampled patients (Patient 17). (Refer to G482). 4. Based on interview and record review, the home health agency (HHA) failed to document an alleged neglect (an act or failure to act which presents an imminent risk of serious harm) by a Registered Nurse 1 (RN 1) while doing patient care in their grievance log and its resolution for one out of 17 sampled patients (Patient 17). (Refer to G484) 5. Based on interview and record review, the home health agency failed to report an alleged neglect (an act or failure to act which presents an imminent risk of serious harm) to the Department of Public Health Licensing and Certification unit within 24 hours as per agency’s policy for one out of 17 sampled patients (Patient 17). (Refer G488) The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal Regulations for Patient Rights to ensure highest quality health care is provided to patients assessed to receive home health services.”

“Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient’s medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This Condition is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation (conditions that health care organizations must meet in order to begin and continue participating in the Medicare [a federal health insurance for people 65 or older, and some people under 65 with certain disabilities or conditions] program) for Care Planning, Coordination, Quality of Care was met as follows: 1. The HHA failed to ensure interventions from the plan of care for one out of 17 sampled patients (Patient 17) were implemented. The agency Registered Nurse (RN1) failed to assessed patient’s existing open wounds at the left amputated foot and right big toe during the home visit (Patient 17). (Refer to G572). 2. The Licensed Nurses failed to provide/follow wound care orders during visits for two of 17 sampled patients (Patients 3 and Patient 17). (Refer to G580). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal Regulations for Patient Rights to ensure highest quality health care is provided to patients who receive home health services.”

“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 interview and record review, the HHA failed to ensure interventions from the plan of care for one out of 17 sampled patients (Patient 17) were implemented. Registered Nurse (RN 1) failed to ensure Patient 17’s existing open wounds at the left amputated foot and right big toe were assessed during the home visit. This deficient practice placed the patient at risk to receive poor quality nursing care that could result to wound infection and slow wound healing. On 11/17/2023, at 4:00 p.m., a complaint validation survey was conducted at the home health agency (HHA) to investigate a complaint allegation. A review of Patient 17’s Face Sheet (admission record), indicated Patient 17 was admitted on 4/30/2023 with the diagnosis that included Type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar) with diabetic peripheral angiopathy (a nerve damage caused by chronically high blood sugar and diabetes) without gangrene. During a review of Patient 17’s Plan of Care (POC, the process of identifying a patient’s needs and facilitating holistic care and ensures collaboration among nurses, patients, and other healthcare providers) for certification period 4/30/2023 to 6/28/2023, the POC indicated an order for RN 1 to provide skilled nursing (SN) visits of three times a week for four weeks, to perform observations of all physical systems and pain each shift and as needed and report all adverse (bad) changes to the physician/RN supervisor/Caregiver. One of the SN intervention was to provide wound care at left foot surgical/dehiscence (a partial or total separation of previously approximated wound edges due to a failure of proper wound healing) as follows: cleanse with normal saline (a mixture of sodium chloride and water, used for cleaning of the wounds), pat dry, cover with Alginate dressing (a type of dressing used in the treatment of wounds) and pad, wrap with Kerlix (a primary dressing) and tape three times a week. During an interview on 11/17/2023, at 5:00 p.m., with the Administrator Designee(ADMD), the ADMD stated he received a call on 6/20/2023 (ADMD was unable to remember the time of the call), from a family member (FM 1), who reported that RN 1 who was assigned to Patient 17, cut the patient’s right ingrown big toe nail, that got swollen and turned black and developed gangrene right after admission to the general acute care hospital (GACH) on 6/6/2023. A review of Patient 17’s Physician’s Progress Note from the General Acute Care Hospital (GACH)’s emergency department, dated 6/7/2023, indicated Patient 17 was identified having a necrotic right big toe and was treated with Zosyn (a medication to treat infections) medication intravenously (administering medication into a vein and directly into the bloodstream). A review of Patient 17’s Skilled Nursing Visit notes from dates 5/1/2023 to 6/4/2023, did not indicate documented evidence that RN 1 had assessed the wound condition at the left foot and right big toe during his visits. During an interview on 11/19/2023 at 1:00 p.m. with the Director of Patient Care Services (DPCS), the DPCS stated RN 1 should have done the skin assessment on every visit. During a review of the undated home health agency’s policy and procedure titled, “Wound Assessment,” indicated during initial and follow-up nursing visits, any non-intact skin areas shall be assessed and document, to complete measurement of the wound (length, width, depth).”

“Information to patient CFR(s): 484.50(a)(1) Provide the patient and the patient’s legal representative (if any), the following information during the initial evaluation visit, in advance of furnishing care to the patient: This Element is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure that one of 17 patients (Patient 7) had their Patient Admission Folder (a folder given to patients at the start of care and consisted of important information for the patients to reference regarding their care) in their home. Due to this deficient practice, Patient 7 was unaware of his rights, and did not have access to important information regarding his care. A review of Patient 7’s “Patient Information” Sheet (face sheet) indicated a start of care date (SOC) of 12/15/2022 and on current certification period of 10/22/2023 to 12/9/2023. Patient 2 had a primary diagnosis of type 2 diabetes mellitus (a chronic condition that effects the way the body processes blood sugar) with foot ulcer (wound). A review of Patent 7’s Plan of Care for certification period 10/11/2023 to 12/9/2023, indicated that Patient 7 was to have skilled nursing visits every other day for two weeks. On 11/18/2023, at 12pm, a home visit was conducted with Licensed Vocational Nurse 1 (LVN 1). During that visit Patient 7’s Patient Admission Folder (a folder given to patients at the start of care and consisted of important information for the patients to reference regarding their care) was requested, but the patient did not have his folder. Patient 7 stated that he threw the folder away eight days ago while cleaning. Patient 7 was unable to describe what information was in the folder. During an interview on 11/18/2023, at 12:46pm, LVN 1 stated that it is important for the patients to have that folder because that is where he documents the patient’s vitals, and the patient medication list is also in the folder. LVN 1 stated that if there is an emergency then all Patient 7’s information is there. During an interview on 11/19/2023, at 12:30pm, the Director of Patient Care Services (DPCS) stated that the Patient Folder is reference for them, which includes information such as, patient teachings, hotline number for them to call if they need assistance or want to make a complaint, and policies. DPCS stated that patients are instructed to keep the folder where it is easy assessable. A review of the Agency’s policy titled “ Rights/Responsibilities”, (undated) indicated that the patient will be informed verbally and in writing during the initial evaluation visit, in advance of furnishing care to the patient, of the following: A. The ownership or control of the organization B. The organization’s mission and care/services provided directly or through contractual arrangements C. The goals of care, the interventions that support those goals and the identification of the staff providing service D. The hours of care/service and how to obtain care/service after hours E. The right to be informed of his/her condition, participate in all aspects of care, and the right to refuse all or part of his/her care to the extent permitted by law F. The right to formulate Advance Directives and the organization’s policy on the withholding of resuscitative services and the withdrawal of life-sustaining treatment… M. The right to privacy, security, and respect of property and person N. The right to be free from mental, physical, sexual and/or verbal abuse, including injuries of unknown source, neglect, misappropriation of property, or exploitation O. The right to voice a complaint or concern regarding care or service. The availability of other sources to receive questions and complaints and assist in resolution… T. The availability of the applicable toll-free home health agency hotline and other sources to receive questions or complaints and assist in resolution including implementation of the advance directive requirements. U. The organization’s transfer and discharge policies. V. The contact information for the agency administrator, including the administrator’s name, business address, and business phone number in order to receive complaints. W. The names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides.”

“State toll free HH telephone hotline CFR(s): 484.50(c)(9) Be advised of the state toll free home health telephone hot line, its contact information, its hours of operation, and that its purpose is to receive complaints or questions about local HHAs. This Element is not met as evidenced by: Based on observation, interview, and record review, the facility failed to advice two of 17 patients (Patients 13 and 14) the toll-free home health telephone hot line to its purpose, lodge complaints, and other concerns regarding care services furnished by the agency. This failure has the potential to result in home health complaints or concerns not being reported by patients and will not be resolved by the agency. a. A review of Patient 13’s Plan of Care (POC, the process of identifying a patient’s needs and facilitating holistic care and ensures collaboration among nurses, patients, and other healthcare providers) indicated a start of care date (SOC) of 6/6/23, with diagnosis that included sacral pressure ulcer. . During a review of Patient 13’s Plan of Care for certification period from 10/4/23 to 12/2/23, the POC indicated an order for the SN (skilled nurse) to visit twice a week for one week, twice a week for three weeks, then re-assess, to perform observations of all physical systems and pain each shift and for assessment of all body system and medication compliance. During a a home visit conducted on 11/18/2023 at 1 p.m., at Patient 13’s residence with LVN 1. Patient 13 was observed sitting on a chair by the dining room. During an interview on 11/18/23, at 1:15 p.m., when Patient 13 was asked if she was told regarding the State hotline number written in the agency folder to call in case if they have a complaint against the agency, she stated she was not aware of it. During an interview on 11/18/23, at 1:15 p.m., during an interview with LVN 2, he stated he was unable to locate the HH toll-free hotline number in the agency folder. b. A review of Patient 14’s Plan of Care (POC, the process of identifying a patient’s needs and facilitating holistic care and ensures collaboration among nurses, patients, and other healthcare providers) indicated a start of care date (SOC) of 11/7/23, with diagnosis that included pulmonary hypertension. During a review of Patient 14’s Plan of Care for certification period from 11/7/23 to 1/5/24, the POC indicated an order for the SN to visit twice a week for one week, twice a week for three weeks, then re-assess, to perform observations of all physical systems and pain each shift and for assessment of all body system and medication compliance. During a a home visit conducted on 11/19/2023 at 10 a.m., at Patient 14’s residence with LVN 3. Patient 14 was observed sitting on a chair by the dining room. During an interview on 11/19/23, at 10:15 a.m., when Patient 14 was asked if she was told regarding the State hotline number written in the agency folder to call in case if they have a complaint against the agency, she stated she was not aware of it. During an interview on 11/19/23, at 10:20 a.m., during an interview with LVN 3, she stated she was unable to locate the HH toll-free hotline number in the agency folder. On 11/19/23, at 1 p.m., during an interview with the DPCS (director of patient care services), he stated the visiting nurse should mention the State hotline number to their patients and should be written in their agency folder.”

“Mistreatment, neglect or abuse CFR(s): 484.50(e)(1)(i)(B) (i)(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 interview and record review, the home health agency failed to conduct an complaint investigation regarding an alleged neglect (an act or failure to act which presents an imminent risk of serious harm) by a Registered Nurse 1 (RN 1) while doing patient care for one out of 17 sampled patients (Patient 17). This deficient practice placed the patient at risk for further harm and for more potential abuse. On 11/17/23, at 4 p.m., a complaint validation survey was conducted at the home health agency (HHA) regarding a neglect allegation that RN 1 cut Patient 17’s right in-grown big toe nail who happened to be diabetic( high blood sugar in the body), that resulted for the right big toe nail to turned black and gangrene(blood flow to a large area of tissue is cut off). A review of Patient 17’s Face Sheet (admission record), the Face Sheet indicated the agency admitted Patient 17 on 4/30/23, with a diagnosis that included Type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar, the body either does not produce enough insulin , or it resist insulin) with diabetic peripheral angiopath( reduce blood flow to tissue) without gangrene. During a review of Patient 17’s Plan of Care (POC, the process of identifying a patient’s needs and facilitating holistic care and ensures collaboration among nurses, patients, and other healthcare providers) for certification period 4/30/23 to 6/28/23, the POC indicated an order for RN 1 to provide skilled nursing (SN) visits of three times a week for four weeks, to perform observations of all physical systems and pain each shift and as needed and report all adverse (bad) changes to the physician/RN supervisor/Caregiver. One of the SN intervention was to provide wound care at left foot surgical/dehiscence as follows: cleanse with normal saline, pat dry, cover with Alginate dressing and pad, wrap with Kerlix and tape three times a week. During an interview on 11/17/23, at 5 p.m., with the Administrator Designee(ADMD), the ADMD stated he received a call on 6/20/2023 (unable to remember the time of call), from a family member (FAM 1), who reported that RN 1 who was assigned to Patient 17, cut the patient’s right in-grown big toe nail, that got swollen and turned black and gangrene right after admission to the general acute care hospital (GACH) on 6/6/2023. When the ADMD was asked if the agency did an incident report regarding the alleged neglected practice, the ADMD stated there was no investigation done at this time. A review of Patient 17’s Physician’s Progress Note from the General Acute Care Hospital (GACH)’s emergency department dated 6/7/23 indicated Patient 17 was identified having a necrotic(death of tissue through injury) right big toe and was treated with Zosyn(treat infection ) medication intravenously. During a review of the agency’s policy and procedure titled, “Abuse, Neglect, or Exploitation,” with a revised date of 7/14/2023, indicated all alleged abuse incidences or circumstances will be thoroughly investigated, and the results of internal investigations will be reported to appropriate enforcement agencies within five (5) working days or as prescribed by state law.”

“Document complaint and resolution CFR(s): 484.50(e)(1)(ii) (ii) Document both the existence of the complaint and the resolution of the complaint; and This Element is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to document an alleged neglect (an act or failure to act which presents an imminent risk of serious harm) by a Registered Nurse 1 (RN 1) while doing patient care in their grievance( complaint) log and its resolution ( decision) for one out of 17 sampled patients (Patient 17). This deficient practice placed Patient 17 and other patients at risk that grievances presented to the HHA will not be addressed and resolved. On 11/17/23, at 4 p.m., a complaint validation survey was conducted at the home health agency (HHA) regarding a neglect allegation that RN 1 cut Patient 17’s right in-grown big toe nail who happened to be diabetic, that resulted for the right big toe nail to turned black and gangrene(dead tissue) A review of Patient 17’s Face Sheet (admission record), the Face Sheet indicated the agency admitted Patient 17 on 4/30/23, with a diagnosis that included Type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar, the body either does not produce enough insulin , or it resist insulin) with diabetic peripheral angiopath ( slow blood flow to tissue) without gangrene( dead tissue) During a review of Patient 17’s Plan of Care (POC, the process of identifying a patient’s needs and facilitating holistic care and ensures collaboration among nurses, patients, and other healthcare providers) for certification period 4/30/23 to 6/28/23, the POC indicated an order for RN 1 to provide skilled nursing (SN) visits of three times a week for four weeks, to perform observations of all physical systems and pain each shift and as needed and report all adverse (bad) changes to the physician/RN supervisor/Caregiver. One of the SN intervention was to provide wound care at left foot surgical/dehiscence as follows: cleanse with normal saline, pat dry, cover with Alginate dressing and pad, wrap with Kerlix and tape three times a week. During an interview on 11/17/23, at 5 p.m., with the Administrator Designee(ADMD), the ADMD stated he received a call on 6/20/23 (unable to remember the time of call), from a family member (FAM 1), who reported that RN 1 who was assigned to Patient 17, cut the patient’s right in-grown big toe nail, that got swollen and turned black and gangrene right after admission to the general acute care hospital (GACH) on 6/6/23023. The ADMD further stated that FAM 1 filed a grievance, but the agency failed to document the complaint in their grievance book in order to find a resolution to the issue as per their agency’s policy. A review of Patient 17’s Physician’s Progress Note from the General Acute Care Hospital (GACH)’s emergency department dated 6/7/23 indicated Patient 17 was identified having a necrotic right big toe and was treated with Zosyn medication intravenously. During a review of the agency’s policy and procedure titled, “Grievances and Complaints”, revised 7/14/2023, indicated at the time of admission, and as needed, patient/client and/or family/caregiver shall be informed of their rights to voice grievances regarding treatment or care, lack of respect of property, or recommend changes in policy, staff, or service/care without restraint, interference, coercion, discrimination, or reprisal. Grievances received from a patient/client and/or family/caregiver will be promptly reported to Office Leadership/Designee for assessment determination.”

“Immediate reporting of abuse by all staff CFR(s): 484.50(e)(2) Any HHA staff (whether employed directly or under arrangements) in the normal course of providing services to patients, who identifies, notices, or recognizes incidences or circumstances of mistreatment, neglect, verbal, mental, sexual, and/or physical abuse, including injuries of unknown source, or misappropriation of patient property, must report these findings immediately to the HHA and other appropriate authorities in accordance with state law. This Element is not met as evidenced by: Based on interview and record review, the home health agency failed to report an alleged neglect (an act or failure to act which presents an imminent risk of serious harm) to the Department of Public Health Licensing and Certification unit within 24 hours as per agency’s policy for one out of 17 sampled patients (Patient 17). This failure resulted in the delay of investigation by the Department of Public Health, and had the potential for the abuse/ neglect to continue, and cause resident’s further physical and psychosocial harm On 11/17/23, at 4 p.m., a complaint validation survey was conducted at the home health agency (HHA) regarding a neglect allegation that RN 1 cut Patient 17’s right in-grown big toe nail who happened to be diabetic, that resulted for the right big toe nail to turned black and gangrene( dead tissue). A review of Patient 17’s Face Sheet (admission record), the Face Sheet indicated the agency admitted Patient 17 on 4/30/23, with a diagnosis that included Type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar, the body either does not produce enough insulin , or it resist insulin) with diabetic peripheral angiopath (slow blood flow to tissue) without gangrene. During a review of Patient 17’s Plan of Care (POC, the process of identifying a patient’s needs and facilitating holistic care and ensures collaboration among nurses, patients, and other healthcare providers) for certification period 4/30/23 to 6/28/23, the POC indicated an order for RN 1 to provide skilled nursing (SN) visits of three times a week for four weeks, to perform observations of all physical systems and pain each shift and as needed and report all adverse (bad) changes to the physician/RN supervisor/Caregiver. One of the SN intervention was to provide wound care at left foot surgical/dehiscence as follows: cleanse with normal saline, pat dry, cover with Alginate dressing and pad, wrap with Kerlix and tape three times a week. During an interview on 11/17/23, at 5 p.m., with the Administrator Designee(ADMD), the ADMD stated he received a call on 6/20/23 (unable to remember the time of call), from a family member (FAM 1), who reported that RN 1 who was assigned to Patient 17, cut the patient’s right in-grown big toe nail, that got swollen and turned black and gangrene right after admission to the general acute care hospital (GACH) on 6/6/23023. When the ADMD was asked if he or their agency reported this alleged neglect act by RN 1 to the Department, he stated the no, that the alleged neglect act should have been reported to the Department within 24 hours in accordance with the regulations. During a review of the agency’s policy and procedure titled, “Abuse, Neglect, or Exploitation,” with a revised date of 7/14/2023, indicated all alleged abuse incidences or circumstances will be reported to appropriate enforcement agencies within 24 hours.”

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on observation, interview, and record review, the home health agency failed to update the medication profile (the list of medications a patient is taking and had used) to reflect the patient’s current medications for four out of 17 sampled patients (Patient 1, Patient 2, Patient 7, and Patent 13). This deficient practice had the potential to place the patients at risk for medication errors and adverse drug reactions. A review of Patient 13’s Plan of Care (POC, the process of identifying a patient’s needs and facilitating holistic care and ensures collaboration among nurses, patients, and other healthcare providers) indicated a start of care date (SOC) of 6/6/23, with diagnosis that included sacral pressure ulcer. .During a review of Patient 13’s Plan of Care for certification period from 10/4/23 to 12/2/23, the POC indicated an order for the Licensed Vocational Nurse (LVN) to provide 80 to 100 hours of skilled nursing (SN) per week and for the Registered Nurse (RN) to visit twice a week for one week, twice a week for three weeks, then re-assess, to perform observations of all physical systems and pain each shift and for assessment of all body system and medication compliance. A physician’s order included in the POC was to administer Cayston inhalation 75 mg (milligrams) one each daily. During a a home visit conducted on 11/18/2023 at 1 p.m., at Patient 13’s residence with LVN 1. Patient 13 was observed sitting on a chair by the dining room. During an observation and a review of Patient 13’s medications on 11/18/2023, at 1:30 p.m., there was a box of Cayston inhalation 75 mg medication that was observed. During an interview on 11/18/23, at 1:40 p.m., with Patient 13, she stated today was the 28th day she stopped using the Cayston inhalation. She also stated that she will start taking the Cayston inhalation medication tomorrow until the next 28th day as ordered by her physician. She also stated that the visiting nurse does not check her medications at all during his visits. A review of the agency’s undated policy and procedure titled, “Administration of Medication, indicated, when there is a discrepancy in the medications, the nurse will contact the physician by telephone as soon as possible to verify the medication regimen. The nurse will instruct the patient and family in the correct medication regimen. The nurse will document all telephone conversations and instructions given to the patient and/or family in the patient clinical record. c. A review of Patient 7’s “Patient Information” Sheet (face sheet) indicated a start of care date (SOC) of 12/15/2022 and on current certification period of 10/22/2023 to 12/9/2023. Patient 2 had a primary diagnosis of type 2 diabetes mellitus (a chronic condition that effects the way the body processes blood sugar) with foot ulcer (wound). A review of Patient 7’s Medication Profile dated 10/11/2023 to 12/9/2023, indicated that the patient was taking the following medications… 1. Chlorthalidone (diuretic: medicine to help reduce fluid build-up in the body by urination) oral (by mouth) 25 milligrams (mg: unit of measurement) 1 tablet (tab) daily. 2. Vitamin D3 oral 50 micrograms (mcg-unit of measurement) 1 capsule (Cap) daily. 3. Gabapentin (medication to treat nerve pain) oral 100 mg, 1 Cap two times day. 4. Humalog KwikPen (diabetes medication) subcutaneous (injected with a needle into the tissue lawyer between the skin and muscle) 100 units/milliliter (ml-unit of measurement) 5 units two times a day. 5. Levemir Flex Touch (diabetes medication) subcutaneous 100 units/ml, 10 units two times a day. 6. Mupirocin External (antibiotic ointment) 2% apply to right foot wound daily. 7. Sodium Polystyrene Sulfonate (used to treat high levels of potassium [electrolyte] in the blood) oral, 15 grams (gm-unit of measurement) 60ml once a week. 8. Tizanidine HCL (muscle relaxant) oral 2mg one tablet two times daily. 9. Aspirin EC (pain medication, also used to lower risk of heart attack) oral 81 mg 1 tab daily. 10. Metoprolol Succinate (blood pressure medicine) oral 25mg one tab two times daily. 11. Atorvastatin Calcium (high cholesterol [fat in the blood] medicine) oral 80mg one tab daily. 12. Farxiga (diabetes medication) oral 5mg one tab daily. 13. Acetaminophen (pain medicine) oral 325mg two tablets every four hours as needed. 14. Loratadine (allergy medicine) oral 10mg one tablet once a day. 15. Glimepiride (diabetes medicine) oral 2mg one tablet daily. 16. Metformin HCL (diabetes medicine) oral 1000mg 1 tablet twice a day. On 11/18/2023, at 12pm, a home visit was conducted with Licensed Vocational Nurse 1 (LVN 1), and the following medication discrepancies were found… 1. Patient 7 was no longer taking Tizandine, Loratadine, Glimepiride, and Metformin. Patient 1 stated that he stopped taking theses medication one month ago. 2. Patient 7 was taking Levemir 12 units two times a day, not 10 units. The fill date of this medication was 3/3/2023. 3. Patient 7 was also taking the following medications that were not listed on his medication profile… a. Acetaminophen plus codeine (narcotic-a strong pain medicine) #3. Oral one tablet two times a day as needed. The medication and a fill date of 4/8/2021 and a discard date of 3/2023. Patient 7 stated that he kept this medication incase he has a lo of pain. b. Meclizine (treats motion sickness and dizziness) oral 25mg take one tablet daily. Fill date 11/7/2023. c. Fluticasone Propionate (allergy medicine) nasal spray 50mcg 1-2 sprays in bth nostrils once a day. Fill date 10/26/2023. d. Doxazosin Mesylate (medicine to treat benign prostate hyperplasia [BPH-age associated prostate gland enlargement in males that can cause urination difficulty]). Fill date 8/10/2023. During an interview on 1/19/2023, at 12:30 pm, the Director of Patient Care Services (DPCS) stated the medication reconciliation is to be done by the nurse at least once a week, and when there are any changes. The nurse should look at the actual medication bottles and compare to the medication profile. The nurse should be checking the medication dosage, frequency and duration. The DPCS stated that the nurse has the capability to update the mediation profile as needed. The DPCS stated that it is important to have an updated medication profile so that the doctor and nurses know what the patient is taking to prevent hospitalizations or prolonged disease process. A review of the Agency’s policy titled “ Medication Profile”, (undated), it indicated that the medication profiles will be updated for each change to reflect current medications and new and/or discontinued medications. a. A review of Patient 1’s Patient Profile indicated a Start of Care (SOC) date on 10/24/2023 with a primary diagnosis of infection (an invasion and multiplication of microorganisms such as bacteria, viruses, and parasites that are not normally present within the body) following a procedure, superficial (on the surface) incisional (a cut of body tissue ) surgical site and a secondary diagnosis of disruption of external operation (a surgery complication where the incision, a cut made during a surgical procedure, reopens) wound. A review of Patient 1’s “Home Health Certification and Plan of Care (POC)” for certification period 10/24/2023 to 12/22/2023, indicated the physician ordered the skilled nurse (SN) to visit daily for 30 days, then reassess. The SN was to assess vital signs, oxygen saturation, self-care tasks, all body system and functional limitation. The SN was to teach/validate patient and patient caregiver diet and medication management: medication’s actions/potential adverse reaction and compliance. A review of Patient 1’s Medication Profile indicated for the following: Ativan (medication used to treat anxiety) oral, one milligram (mg, unit of measure) ½ tab orally daily. During a joint home visit with Case Manager (CM 1) on 11/18/2023 at 11:00 a.m., Patient 1’s medications were reviewed. The label on the Lorazepam bottle indicated Lorazepam, one mg by mouth every six to eight hours as needed. b. A review of Patient 2’s Patient Profile indicated a Start of Care (SOC) date on 10/18/2023 with a primary diagnosis of Parkinson’s disease (a progressive disorder that affects the nervous system and the parts of the body controlled by the nerves) without dyskinesia (involuntary, erratic, writhing movements of the face, arms, legs or trunk). A review of Patient 2’s “Home Health Certification and Plan of Care (POC)” for certification period 10/18/2023 to 12/16/2023, indicated the physician ordered the physical therapist (PT) to visit once a week for nine weeks for skilled assessment and observation of patient musculoskeletal and functional status, activity tolerance and pain level and for the occupational therapist (OT) to evaluate functional abilities, activity tolerance and endurance, need for therapeutic exercises, need for adaptive equipment, energy conservation technique, pacing activities training, transfer training, and home exercise program.to visit twice a week for four weeks and once a week for one week. A review of Patient 1’s Medication Profile indicated for the following: 1. Cholecalciferol (Vitamin D3, vitamin that helps your body absorb calcium and phosphorus) Oral, 50 micrograms (mg, unit of measure), 2,000 Units, one capsule, take 2,000 units by mouth once a day. 2. Omeprazole (medication used to treat heartburn, a damaged esophagus, stomach ulcers, and gastroesophageal reflux disease (GERD, a common condition in which the stomach contents move up into the esophagus) Oral, 20 mg capsule, take one tablet by mouth every night. 3. Lamotrigine (anticonvulsant) oral, 25mg, two tables, take two tablets by mouth 2 times a day. 4. Donepezil hydrochloride (medication used to treat dementia [memory loss and mental changes] associated with mild, moderate, or severe Alzheimer’s disease) Oral, five mg tablet, take one tablet by mouth once a day at bedtime. During a joint home visit with Case Manager (CM 1) on 11/18/2023 at 12:30 p.m., Patient 2’s medications were reviewed and the following were observed: 1. Cholecalciferol Oral, 125 micrograms (mg, unit of measure), Suggested use: Take 1 tablet daily with food as a dietary supplement or as directed by a healthcare professional. 2. Omeprazole Oral, 20 mg capsule, take one capsule before a meal. 3. Lamotrigine (anticonvulsant) oral, 25mg, four tablets, take four tablets by mouth in the morning and two tables in the evening. The Case Manager (CM) stated that the medication label instructions on the bottles were different than Patient 2’s medication profile. During an interview on 11/18/2023 at 12:46 p.m., Family Member (FM 2) stated that she managed Patient 2’s medications and that the doctor had discontinued the Donepezil on 10/22/2023. A review of the HHA’s (undated) policy titled “Medication Profile,” indicated that patients receiving medication will have a current, accurate medication profile in the clinical record. The policy further indicated that medication profiles will be updated for each change to reflect current medications and new and/or discontinued medications.”

“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 interview and record review, the Licensed Nurses failed to provide/follow wound care orders during visits for two of 17 sampled patients (Patients 3 and Patient 17). - For Patient 3, the visiting nurse failed to provide wound care as ordered. - For Patient 17, RN 1 (registered nurse) failed to provide correct wound care as ordered. This deficient practice placed the patient’s wound at risk for slow healing and complications. b. A review of Patient 17’s Face Sheet (admission record), the Face Sheet indicated the agency admitted Patient 17 on 4/30/2023, with a diagnosis that included Type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar) with diabetic peripheral angiopathy (damage to cells in the blood vessels caused by the high level of glucose) without gangrene. During a review of Patient 17’s Plan of Care (POC, the process of identifying a patient’s needs and facilitating holistic care and ensures collaboration among nurses, patients, and other healthcare providers) for certification period 4/30/2023 to 6/28/2023, the POC indicated an order for RN 1 to provide skilled nursing (SN) visits of three times a week for four weeks, to perform observations of all physical systems and pain each shift and as needed and report all adverse (bad) changes to the physician/RN supervisor/Caregiver. One of the SN intervention was to provide wound care at left foot surgical/dehiscence (a partial or total separation of previously approximated wound edges due to a failure of proper wound healing) as follows: cleanse with normal saline, pat dry, cover with Alginate dressing (a type of dressing) and pad, wrap with Kerlix (a type of dressing) and tape three times a week. A review of Patient 17’s Skilled Nursing Visit dated 5/25/2023, indicated RN 1 performed wound care at patient’s foot amputation surgical site by cleansing the wound with Normal Saline, patted dry, painted with Betadine (a topical antiseptic), followed by Prisma Alginate dressing (a type of dressing to support wound healing), Maxorb AG dressing (a dressing used for moderate or heavily draining wounds), followed by 4x4 dressing (type of dressing), rolled gauze and secured with tape. During an interview with the DPCS on 11/19/2023, at 2:00 p.m., the DPCS stated RN 1 should be following correct wound care orders for Patient 17. A review of the HHA’s undated policy, “Care Planning Process,” indicated that the plan of care will be based upon the physician’s (or other authorized licensed independent practitioner’s) orders and will encompass the equipment, supplies, and services required to meet the patient’s needs. On 11/17/2023, at 4:00 p.m., a complaint validation survey was conducted at the home health agency (HHA) to investigate a complaint allegation. a. A review of Patient 3’s Patient Profile indicated a Start of Care (SOC) date of 6/20/2023 with a primary diagnosis of encounter for attention to cystostomy (a surgical creation of an opening into the bladder) and a secondary diagnosis for encounter for attention to other artificial opening of urinary tract (a surgical procedure to create a stoma (artificial opening) so that urine can pass out of the body through the abdominal wall. A review of Patient 3’s “Home Health Certification and Plan of Care (POC)” for certification period 10/18/2023 to 12/16/2023, indicated the physician ordered the skilled nurse (SN) to visit once a week for four weeks then reassess. The POC indicated SN to perform proper right nephrostomy (an opening between kidney [blood filtering organs] and the skin to drain urine) care as ordered: cleanse with normal saline (a mixture of sodium chloride and water, used for cleaning of wounds), pat dry and cover with split gauze (a type of dressing) every SN visit using aseptic (medically clean or without infection) technique and proper disposal of contaminated materials. A review of SN notes dated 11/2/2023, 11/9/2023, and 11/16/2023 indicated “SN provided nephrostomy care, dressing changed.” There was no indication that the nephrostomy was cleansed with normal saline and pat dried. During a concurrent interview and record review on 11/19/2023 at 12:40 p.m. with the Administrator designee (ADMD), Patient 3’s treatment order in the plan of care (POC) and nurse’s notes dated 11/2/2023, 11/9/2023, and 11/16/2023 were reviewed. The ADMD stated that the wound care orders in the plan of care was not indicated step by step in the narrative of the nurse’s note. The ADMD stated it was important to document the treatment step by step to ensure that the nurse is following specific instruction on Patient 3’s nephrostomy care.”

“Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This Element is not met as evidenced by: Based on interview and record review, the Home Health Agency’s Administrator, who is responsible for the day-to-day operation of the home health agency, for one of 17 sampled patients (Patient 17), failed to ensure an alleged allegation of neglect (an act or failure to act which presents an imminent risk of serious harm) was handled and investigated timely, reported to the Department of Public Health Licensing and Certification unit, and abuse trainings were provided to the home health agency staff. This failure resulted in the delay of alleged neglect investigation by the Department of Public Health, and had the potential to cause resident’s further physical and psychosocial harm. On 11/17/2023, at 4:00 p.m., a complaint validation survey was conducted at the home health agency (HHA) regarding an alleged neglect allegation that RN 1 cut Patient 17’s right ingrown big toe nail who was diabetic (a long term disease in which the body cannot regulate the amount of sugar in the blood), that resulted in the right big toe nail to turn black and develop gangrene (a death of body tissue due to lack of blood flow or a serious bacterial infection). A review of Patient 17’s Face Sheet (admission record), indicated Patient 17 was admitted on 4/30/2023 with the diagnosis that included Type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar) with diabetic peripheral angiopathy (a nerve damage caused by chronically high blood sugar and diabetes) without gangrene. During a review of Patient 17’s Plan of Care (POC, the process of identifying a patient’s needs and facilitating holistic care and ensures collaboration among nurses, patients, and other healthcare providers) for certification period 4/30/2023 to 6/28/2023, the POC indicated an order for RN 1 to provide skilled nursing (SN) visits of three times a week for four weeks, to perform observations of all physical systems and pain each shift and as needed and report all adverse (bad) changes to the physician/RN supervisor/Caregiver. One of the SN intervention was to provide wound care at left foot surgical/dehiscence (a partial or total separation of previously approximated wound edges due to a failure of proper wound healing) as follows: cleanse with normal saline (a mixture of sodium chloride and water, used for cleaning of the wounds), pat dry, cover with Alginate dressing (a type of dressing used in the treatment of wounds) and pad, wrap with Kerlix (a primary dressing) and tape three times a week. During an interview on 11/17/2023, at 5:00 p.m., with the Administrator Designee (ADMD), the ADMD stated he received a call on 6/20/2023 (ADMS was unable to remember the time of call), from a family member (FM 1), who reported that RN 1 who was assigned to Patient 17, cut the patient’s right ingrown big toe nail, that got swollen and turned black and developed gangrene right after admission to the general acute care hospital (GACH) on 6/6/2023. When the ADMD was asked if the agency did an incident report regarding the alleged neglect practice, the ADMD stated there was no investigation done at this time. A review of Patient 17’s Physician’s Progress Note from the General Acute Care Hospital (GACH)’s emergency department, dated 6/7/2023, indicated Patient 17 was identified having a necrotic right big toe and was treated with Zosyn (a medication to treat infections) medication intravenously (administering medication into a vein and directly into the bloodstream). During an interview on 11/19/2023, at 12:50 p.m., with the Administrator (ADM), the ADM was asked about his job description. The ADM stated as an Administrator, he is responsible for the day-to-day operation (function) of the HHA. The ADM was asked if abuse/neglect prevention training were provided to the staffs, the ADM stated the agency should have provided abuse prevention training yearly to all staff, however, the ADM was unable to provide evidence of conducted abuse/neglect training. When asked ADM if there was an neglect investigation report done by the agency for Patient 17, the ADM stated, “None at this time”. Asked ADM if Patient 17’s family member’s grievance regarding the alleged neglect by RN 1 was filed, ADM stated, “No”. When asked ADM if the HHA reported alleged neglect to the Department in an appropriate time frame, ADM stated, “No”. A review of the HHA’s “Operation Manager Job Description”, indicated, that one may serve in the capacity of office administrator, appointed by and reporting to the governing body, and responsible for all day-to-day operations of the office. Those duties include to be responsible for ongoing compliance with all current federal, state, and local regulations, company policies and procedures, accrediting organization standards, and reimbursement guidelines, oversees the handling of patient and employee complaints and is responsible for timely responses to grievances, Responsible for completion of all required reports and corrective action plans, and adheres to and promotes agency’s policies and procedures.”

“In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This Element is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to implement its policy and procedure on Abuse (the willful infliction of injury, unreasonable confinement, intimidation, or punishment with resulting physical harm, pain or mental anguish. Abuse also includes the deprivation by an individual, including a caretaker, of goods or services that are necessary to attain or maintain physical, mental, and psychosocial well-being), Neglect (refusal or failure of a caregiver to provide for the needs of a vulnerable adult), or Exploitation (taking improper advantage of an individual. It could involve finances, material, labor, or activity) and provide abuse in-service trainings to the HHA staff. This deficient practice placed all the patients at risk for potential abuse by the home health agency staff. On 11/17/2023, at 4:00 p.m., a complaint validation survey was conducted at the home health agency (HHA) regarding an alleged neglect allegation that RN1 cut Patient 17’s right ingrown big toe nail who was diabetic (a long term disease in which the body cannot regulate the amount of sugar in the blood), that resulted in the right big toe nail to turn black and develop gangrene (a death of body tissue due to lack of blood flow or a serious bacterial infection). A review of Patient 17’s Face Sheet (admission record), indicated Patient 17 was admitted on 4/30/2023 with the diagnosis that included Type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar) with diabetic peripheral angiopathy (a nerve damage caused by chronically high blood sugar and diabetes) without gangrene. During a review of Patient 17’s Plan of Care (POC, the process of identifying a patient’s needs and facilitating holistic care and ensures collaboration among nurses, patients, and other healthcare providers) for certification period 4/30/2023 to 6/28/2023, the POC indicated an order for RN 1 to provide skilled nursing (SN) visits of three times a week for four weeks, to perform observations of all physical systems and pain each shift and as needed and report all adverse (bad) changes to the physician/RN supervisor/Caregiver. One of the SN intervention was to provide wound care at left foot surgical/dehiscence (a partial or total separation of previously approximated wound edges due to a failure of proper wound healing) as follows: cleanse with normal saline (a mixture of sodium chloride and water, used for cleaning of the wounds), pat dry, cover with Alginate dressing (a type of dressing used in the treatment of wounds) and pad, wrap with Kerlix (a primary dressing) and tape three times a week. During an interview on 11/17/2023, at 5:00 p.m., with the Administrator Designee (ADMD), the ADMD stated he received a call on 6/20/2023 (ADMS was unable to remember the time of call), from a family member (FM 1), who reported that RN 1 who was assigned to Patient 17, cut the patient’s right ingrown big toe nail, that got swollen and turned black and developed gangrene right after admission to the general acute care hospital (GACH) on 6/6/2023. When the ADMD was asked if the agency did an incident report regarding the alleged neglect practice, the ADMD stated there was no investigation done at this time. A review of Patient 17’s Physician’s Progress Note from the General Acute Care Hospital (GACH)’s emergency department, dated 6/7/2023, indicated Patient 17 was identified having a necrotic right big toe and was treated with Zosyn (a medication to treat infections) medication intravenously (administering medication into a vein and directly into the bloodstream). During an interview on 11/19/2023, at 12:50 p.m., with the Administrator (ADM), the ADM was asked if abuse prevention trainings were provided to their HHA staff, the ADM stated the agency should provide abuse prevention training every year to all the staff, but the ADM was unable to provide evidence that abuse trainings were provided to the staff. During a review of the agency’s policy and procedure titled, “Abuse, Neglect, or Exploitation,” with a revised date of 7/14/2023, indicated each employee will receive training regarding possible signs and/or symptoms of abuse, neglect and exploitation and be oriented and be familiar with the process of reporting and investigating suspected incidents of abuse, neglect, or exploitation of patient/clients and/or family/caregiver.”