Ensure Home Health Care, Inc.

“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 observation, interview and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation regarding Care Planning, Coordination, Quality of Care was met as follows: 1. The HHA failed to ensure to provide care and services to one of seven sampled patients (Patient 4), who had visual impairment, as ordered by the primary physician by; a. The visiting nurse did not identify all current medications prescribed by the Patient 4’s Primary Medical Doctor (PMD). b. Licensed Vocational Nurse (LVN 1) 1 failed to identify and verify that Patient 4 received Environmental mix Cat & Dog vials subcutaneous injection (the injection given in the fatty tissue, just under the skin) every week, from 6/2023 to 2/23/2024, that was administered by Patient 4’s roommate without training received from the home health agency and without the knowledge of the primary home health physician. This deficient practice resulted in Patient 4 not receiving prescribed medication and placed Patient 4 at high risk to experience undetected serious complication from injection, that included, infection on the injection site and gangrene (death of body tissue due to a lack of blood flow or a serious bacterial infection). (Refer to G580) 2. The home health agency (HHA) failed to update, develop, and incorporate changes in the plan of care (POC, a plan should outline what needs to be done to manage patient care needs. It can help organize and prioritize caregiving activities) for one out of seven sampled patients (Patient 4) by failing to: a. Identify when Patient 4 was relocated to another home two weeks ago and develop a plan of care for safety to ensure safe environment for Patient 4 who had visual impairment. (G 572) b. Develop a plan of care when Patient 4 had an asthma attack ( a chronic condition that inflames and narrows the airways in the lungs) and visited urgent care on 2/13/2024. (G 572) c. Develop a plan of care for lower abdominal pain due to urinary tract infection. Patient 4 had telehealth visit with her Primary Medical Doctor (PMD) on 2/21/2024. (G 572) d. Develop a plan of care for safe administration and monitoring of subcutaneous (applied under the skin) injectable medication named Environmental Mix Cat/Dog (medication to boost immune system and to help with allergies). (G 572) 3. The home health agency (HHA) failed to document all patient care orders in the clinical records for one out of seven sampled Patients (Patient 4). (G 576) These deficient practice had the potential to cause severe harm, severe injury, pain or even death to Patient 4 who was was extremely visually impaired has severe asthma and was suffering from abdominal pain due to urinary tract infection and unable to administer her medications in the independent living. The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily (written rules or law) mandated compliance with Federal Regulations for Care Planning, Coordination of Services, and Quality of Care to ensure highest quality health care provided to patients assessed to receive home health services. For Patient 1, the patient had an open wound at left mid foot amputation, but the visiting nurse failed to do a wound assessment on every visits. This deficient practice placed the patient at a potential risk for delayed wound healing, a decline in the condition of the wound, and possible risk for infection on the wound site.”

“Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to ensure the emergency preparedness plan (EPP, the steps taken to make sure patients and staffs are safe before, during and after an emergency or natural disaster) policy was reviewed and updated in an annual basis. This deficient practice had the potential to result in office and field staff to lack knowledge that could result in respond ineffectively when an emergency/disaster situation occur. A request was made to the Administrator on 2/25/2024 at 11:30 a.m. to review the agency’s Emergency Preparedness Plan. On concurrent record review of the document titled “Emergency Operations Plan” indicated that the HHA was not able to update their policy since the inception of a new Administrator (ADM). Further review showed that the former administrator is still listed as the Incident Commander (IC) during emergency response and not the current ADM. During a joint interview with the Chief Executive Officer (CEO) and the current Administrator (ADM) on 2/25/2024 at 1:30 p.m., both CEO and ADM confirmed that they have not reviewed their policies and procedure which they were supposed to do annually. A review of the undated HHA’s policy titled “Emergency Operation Plan” indicated in the event of emergency/ disaster situation that could adversely affect delivery of care, the agency will implement a plan designed to minimize disruption of agency services and provide for the care for all patients. The overall plan considers the agency’s commitment to provide service while ensuring the safety of its patients and staff. The HHA has developed and Emergency Operations Plan for staff and patients that may quickly be implemented in the event of an Emergency Disaster. The Commander in chief that will initiate the Earthquake Disaster is the Director/Administrator. The HHA will keep and maintain a current list of contact information for staff, staff family members, patients, vendors, pharmacy for replenishing medications, DME (durable medical equipment) company for any equipment and supplies needed, maintain list of emergency services , hospitals and other appropriate resources.”

“EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, “Organizations” under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF’s emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This Standard is not met as evidenced by: Based on record review and an interview, the home health agency (HHA) failed to ensure the emergency preparedness (EP, the steps taken to make sure patients and staffs are safe before, during and after an emergency or natural disaster) plan/drill for field staffs in-service training/drill were completed in an annual basis. This deficient practice had the potential to result in office and field staff to lack knowledge to respond effectively when an emergency/disaster situation occur. A request was made to the Administrator on 2/25/2024 at 11:30 a.m. to review the agency’s Emergency Preparedness Plan. On concurrent review of the document titled “Emergency/Disaster Management Meeting” attendance sheet indicated that only office staff attended the emergency drill. During a review of the HHA’s employee files on 2/25/2024 indicated, the HHA had a total of 5 registered nurses (RN), 5 licensed vocational nurses (LVN) and 1 home health aide (HHA) as full-time employees and outsourcing licensed nurses from a contracted nurse registry. There was no documented evidence that the field staff and their contracted nursing agency attended the emergency management training. During a joint interview on 2/25/2024 at 1:30 p.m., with the Administrator (ADM) and the Chief Executive Officer (CEO) of the HHA, CEO stated that the new ADM started in January 2023 and they were unable to conduct an emergency drill for the past year since the former Administrator/Director of Nursing left the agency. On concurrent record review of the agency’s document titled “Emergency/Disaster Management Meeting showed that the agency conducted their last meeting former Admin/DON last 9/15/2023. A review of the undated HHA’s policy titled “Emergency Operation Plan” indicated in the event of emergency/ disaster situation that could adversely affect delivery of care, the agency will implement a plan designed to minimize disruption of agency services and provide for the care for all patients. The overall plan considers the agency’s commitment to provide service while ensuring the safety of its patients and staff. Mandatory attendance and in-service education and Disaster/Emergency Plan Agency staff and contractual emphasis on Disaster/Emergency Plans at initial orientation for all newly hired staff then annually during annual performance evaluation.”

“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 observation, interviews, and record reviews, the home health agency (HHA) failed to update, develop, and incorporate changes in the plan of care (POC, a plan should outline what needs to be done to manage patient care needs. It can help organize and prioritize caregiving activities) for two out of seven sampled patients (Patients 1 and 4). For Patient 1, the patient had an open wound at left mid foot amputation, but the visiting nurse failed to do a wound assessment on every visits. This deficient practice placed the patient at a potential risk for delayed wound healing, a decline in the condition of the wound, and possible risk for infection on the wound site. The HHA failed to: Identify when Patient 4 was relocated to another home two weeks ago and develop a plan of care for safety to ensure safe environment for Patient 4 who had visual impairment. Develop a plan of care when Patient 4 had an asthma attack ( a chronic condition that inflames and narrows the airways in the lungs) and visited urgent care on 2/13/2024. Develop a plan of care for lower abdominal pain due to urinary tract infection. Patient 4 had telehealth visit with her Primary Medical Doctor (PMD) on 2/21/2024. Develop a plan of care for safe administration and monitoring of subcutaneous (applied under the skin) injectable medication named Environmental Mix Cat/Dog (medication to boost immune system and to help with allergies). These deficient practices may result not identifying patient care needs, delaying the care, and jeopardizing patient safety. A review of Patient 4’s document titled “Home Health Certification and Plan of Care” on 2/25/2024 for the certification period of 1/12/2024 to 3/11/2024, indicated that Patient 4 was admitted on 1/12/2024 with the medical diagnosis of bilateral primary osteoarthritis (inflammation of the joints), angina pectoris (squeezing, pressure, heaviness, tightness or pain in the chest), mild intermittent asthma (a chronic condition that inflames and narrows the airways in the lungs), and cataract (a medical condition in which the lens [a clear, curved structure at the front of the eye] of the eye becomes cloudy which causing impaired vision) of the left eye. The record also indicated Skilled Nursing (SN) visit once a week for nine weeks to certify for comprehensive skilled nursing assessment, … and therapeutic response and compliance to prescribed medication/diet regimen. SN to assess pain level using pain scale, with 7-10/10 being severe (numeric pain scale to describe person’s pain level zero to ten, zero indicates no pain, ten indicates severe pain) and implement pain relief measures and evaluate its effectiveness. The record indicated intervention to assess patient’s home environment for safety and sanitation hazards and identify risks and hazards. On 2/24/2024, during a joint home visit at 10:15 a.m., with the Director of Nursing (DON) at Patient 4’s independent living home, observed that the home was under renovation. DON stated that upon her arrival she spoke to the owner’s son and the son stated that the independent living was under renovation and that patients were all moved out to a different location two weeks ago. On 2/24/2024, at 10:40 a.m., upon arrival at the new home address of Patient 4, observed furniture, boxes and other home furnishings were disorganized and scattered in the living room and hallway. Inside the Patient 4’s room noted there was one stair step down going into her bedroom. During a joint interview with the Administrator (ADM) and the Chief Executive Officer (CEO) on 2/25/2024 at 11:00 a.m., ADM stated she does the medical coding and OASIS (Outcome and Assessment Information Set (OASIS) is a group of standard data elements home health agencies (HHAs) integrate into their comprehensive assessment, to collect and report quality data to the Centers for Medicare & Medicaid Services [CMS] review). ADM also stated that she was informed by the independent living for Patient 4’s change of address, but she was not able to inform the DON of Patient 4’s current location. During an interview and observation with Patient 4 on 2/24/2024 at 11:30 a.m., Patient 4 stated that she has new medication prescribed by her PMD. Patient 4 stated that she went to the urgent care on 2/13/2024 due to difficulty of breathing. Patient further stated that she had a telehealth (video visits) visit with PMD for her lower abdominal pain due to urinary tract infection on 2/21/24. During a review of Patient 4’s medications on hand, Patient 4 presented a subcutaneous injectable medication named Environmental Mix Cat/Dog and stated that she was taking this medication every Friday prescribed by her primary doctor since June 2023. Patient 4 stated that she was tested for allergies for complaints of severe skin itching. Patient 4 further stated that since she is unable to see and administer the medication herself, her roommate administers her injectable medication for her. Observed Patient 4 had unopened bottle of Pyridium (a medication to relieve symptoms caused by the urinary tract infections and urinary problems) medication dated 2/13/2024 for urinary tract infection. Further review of medications indicated that Patient 4 had a weekly medication planner in braille (a form of written language for blind people, in which characters are represented by patterns of raised dots that are felt with the fingertips). On concurrent interview with Patient 4, patient stated that she does not know how to read braille. Patient 4 stated that her roommate helps manage her weekly pillbox. Patient 4 added that she received inhaler (a device used to push the medication into the lungs) for her shortness of breath. A review of Patient 4’s discharge summary from an urgent care, provided by Patient 4 and dated 2/13/2024, indicated that Patient 4 was prescribed four medications that were not listed in her medication profile (a drug profile or written summary of all the medicines patient is taking regularly, including over-the-counter and complimentary medicines). A review of Patient 4’s medication profile provided by the agency, indicated, Pyridium (a medication to relieve symptoms caused by the urinary tract infections and urinary problems) medication dated 2/13/2024 for urinary tract infection was not in Patient 4’s medication profile. During an interview with Patient 4’s Roommate (Roommate 1) on 2/24/2024 at 1:00 p.m., Roommate 1 stated that she manages the weekly pillbox for Patient 4 because she could not see. Roommate 1 stated she is also administering the subcutaneous injectable medication (Environmental Mix Cat/Dog) to Patient 4 every Friday. When asked how much subcutaneous injection medication she administers to the patient, Roommate 1 stated, “There are lines in the injection, and they told me to get the medicine up to this line only (demonstrating) and give it to her”. When asked does she know how much medication is on that line, Roommate 1 stated, “No, but I was a former doctor in the Philippines, so I know what I am doing.” When asked if she was instructed how to give the injectable medication, roommate stated, “A person came here to deliver the medications and he taught me how to give the medicine.” When asked Roommate 1 if the person who delivered was the doctor, she stated, “I don’t know.” During an interview with the independent living caregiver (Caregiver 1) on 2/24/2024 at 1:00 p.m., Caregiver 1 stated that they are not trained to monitor their patient’s medications and does not administer any injectable medication for them. Caregiver 1 stated that all of their patients keep their own medications inside their room. During an interview with the DON on 2/24/24 at 1:30 p.m., DON stated that the nurse should check the medications every home visit instead of the patient who cannot see and definitely not the roommate and if there are any changes, nurse should notify the agency immediately. DON further stated after clarifying with the doctor, the nurse should update the plan of care. DON stated that every 30 days, there should be an assessment conducted by the registered nurse. DON further stated that she was not aware that Patient 4 went to the urgent care on 2/13/2024 and had a telehealth visit with the primary medical doctor on 2/21/2024. A phone call attempt was made to Patient 4’s Primary Medical Doctor (PMD) on 2/27/2023 at 11:46 a.m., but PMD was unavailable for the interview. Office staff (OS 1) stated that they are taking care of Patient 4 and conducted an allergy test on 8/20/2023. OS 1 stated Patient 4 was tested positive for multiple allergies. OS 1 further stated the doctor did prescribe an “immunity kit” also called “Environmental Mix Cat/Dog” to help to boost her immunity to help her with her allergies. OS 1 it was delivered to her home by the mobile driver/phlebotomist (a medical professional who’s trained to perform blood draws) and taught the patient how to administer the medication. When asked if the phlebotomist and the PMD knew that Patient 4 is unable to see and administer the medication herself, the OS 1 stated, “I do not know.” When asked about how much is the dose and how frequent the medication should be taken, OS 1 stated “I am not licensed to tell you further information about the medication and a nurse practitioner will call for the correct prescription. Not received any call back. A review of Patient 4’s electronic medical record (EMR) indicated no documentation from the assigned visiting nurse in the Patient 4’s record for the month of February. Further review of the records indicated that the HHA had not conducted and documented a “30-day case summary” (an objective measurement of function in accordance with accepted professional standards of clinical practice enabling comparison of successive measurements to determine the effectiveness of therapy goals. These assessments “may include but are not limited to eating, swallowing, bathing, dressing, toileting, walking, climbing stairs, or using assistive devices, and mental and cognitive factors to fully examine the effectiveness of the current therapy). Patient 4’s EMR indicated that there were no doctor’s orders for the medications for urinary tract infection, asthma, and the subcutaneous injectable medication in the electronic medical record. The EMR further indicated there was no updated plan of care for Patient 4’s for change in condition. Patient 4’s record indicated there was no communication notes or documentation for Patient 4’s change of address. A review of the HHA’s undated policy titled “ Coordination of Care Policy 2-060.1,” indicated the purpose of the policy is to ensure continuity of care, to assume that the goals of individual services are complementary to the client’s total care plan and reflect cooperative planning, and to ensure the identification of patient needs and barrier to care. The policy further indicated, “It is the policy of the HHA to maintain a system of communication and integration of services, whether provided directly or under arrangement. The Director of Patient Care Services/Nursing Supervisor will coordinate services provided to the client by agency. The office coordinator will be informed by the Director of Patient Care Services/Nursing Supervisor of the types of services that the client needs… The Skilled Nursing Services will assure that the Plan of Care is available to the health care personnel or organization. The Skilled Nursing Services will communicate weekly with the health care personnel or organization via telephone conference, in person, or weekly review of notes, to discuss the client’s care and response to treatment. Case management and monitoring are accomplished on a consistent basis through home visits, telephone contacts and care coordination to ensure the delivery of quality care to the client. All activities are documented in the client’s clinical record on the appropriate form (care coordination form or visit notes). The client, family, physician, and all involved agency staff participate in case management activities and maintain liaison to assure that their efforts effectively complement one another and support the objectives outlined in the client’s Plan of Care. All services must coordinate with the agency (Nursing Supervisor and/or DPCS) about services being ordered and implemented and each service must provide documentation of what was performed within seven (7) days after the performance of the visit done. Home and community resources, in addition to those of the agency are utilized to the fullest in order to ensure coordination of care, thus providing the client with the most comprehensive home health care plan possible. A review of the HHA’s undated policy titled “Physician Notification of Changes in Care,” indicated the patient will be notified within 24 hours of any significant changes in the agreed-upon schedule or plan of care. Any significant changes will be called into the office (i.e., moving a visit from morning to afternoon). Whenever the plan of care is changed, including services, frequencies, treatments, etc., the patient will be notified at the time of the visit. A review of the HHA’s undated policy titled “Coordination of Services with other Providers Policy No 2-035.1,” indicated the purpose of the policy is to ensure the coordination of services provided by the organization and by other service providers. The Case Manager will be responsible for coordinating services provided to the patient by the organization, including services provided directly and through contract. The Case Manager will act as liaison with other organizations or individuals also providing care to the patient to ensure effective coordination of related services. Other providers and all referrals to other service providers will be documented in the clinical record. The other service provider will be responsible to contact the physician (or other authorized licensed independent practitioner) for orders for its evaluation and treatment. Ongoing communication regarding issues and concerns with the organizations or individuals providing care will be the responsibility of agency. A review of Patient 1’s admission record indicated Patient 1 was admitted to the facility on 2/13/24, with diagnoses that included hypertensive heart disease (a constellation of changes in the left ventricle, left atrium and coronary arteries as a result of chronic blood pressure elevation). A review of Patient 1’s plan of care (POC) from 2/13/24 to 4/12/24, included a SN (skilled nurse) frequency visits of twice a week for 9 weeks, to observe/assess all body systems focusing on integumentary (skin) system. One of the SN intervention is to provide wound care at left mid foot amputation as follows: to cleanse with Normal Saline, apply Santyl ointment, cover with 4x4 dressing with gauze, Kerlix wrap and Ace bandage twice a week. A review of Patient 1’s Comprehensive Adult Nursing Assessment (OASIS-to determine the need for nursing services) dated 2/13/24, indicated the patient had an open wound at left mid foot amputation. However, there was no documented evidence a wound skin assessment of a size measurement and wound description was done. A review of Patient 1’s Nursing Progress Notes dated 2/15, 2/20, and 2/22/24, indicated no documented evidence a wound skin assessment were done during the visits. On 2/25/24, at 12 p.m., during an interview with the DPCS, she stated she stated Patient 1’s left mid foot amputation open wound should be assessed on every visit. According to the agency’s policy and procedure “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) shall be documented during visits.”

“Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA’s governing body. This Standard is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to collect data quarterly for the Quality Assurance and Performance Improvement (QAPI, is a data driven and proactive approach to quality improvement for continuously identifying opportunities for improvement) to be able to identify problems and ensure quality of care was provided. This deficient practice had the potential to affect quality of care and services being provided to patients under their care. During the recertification survey, on 2/25/2024 at 1:30 p.m., requested the HHA for the agency’s QAPI program data for review. During a review of the HHA QAPI on 2/25/2024, the QAPI documents indicated the HHA had no relevant data or program to present. During a joint interview on 2/25/2024 at 1:30 p.m., with the Chief Executive officer (CEO) and the Administrator (ADM), the CEO and the ADM stated the governing body, CEO, ADM and Director of Nursing (DON) were the members of the QAPI committee. When asked about details of the results of the QAPI, ADM could not explain how the agency ended up with the results. ADM stated that the program automatically populates the data in the electronic medical record. ADM stated that they had a discussion about patient satisfaction and all patients were satisfied with their care. When asked to present her data for the patient satisfaction survey review of the patients, ADM could not provide evidence of data collected. A review of the undated HHA policy titled “Position: Administrator” indicated the ADM’s responsibility is to plan, develop and direct the programs, services, activities and employees of the Agency. The administrator shall represent the governing body in the daily operation of the agency. His responsibilities include: Keeping the governing body fully informed of the conduct of the agency through regularly written reports and by attendance at meetings of the governing body. Employing qualified personnel and arranging for their orientation and continuing education. Developing and implementing an accounting and reporting system that reflects the fiscal experience and financial position of the agency. Assures compliance with federal/state regulations governing home health care services. Provides leadership in developing and maintaining data collection, recording, and reporting systems to ensure proper service, uniform accounting, data collection, and measurement of outcomes”

“Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency’s overall management and operation, the provision of all home health services, fiscal operations, review of the agency’s budget and its operational plans, and its quality assessment and performance improvement program. This Standard is not met as evidenced by: Based on interview and record review, the governing body failed to assume full legal authority and responsibility for the overall management and operation of the HHA. This deficient practice had the potential to result in the substandard quality of care that could affect the health and safety of the patients During the recertification survey on 2/23/2024 to 2/25/2024, a request was made to the Administrator (ADM) and the Chief Executive officer (CEO) for their governing body minutes. During a joint interview with the Chief Executive office (CEO) and the Administrator (ADM) on 2/25/2024 at 1:30 p.m., CEO was asked how he presides with the governing body meeting, CEO stated that he just gives minor reminders like washing hands and wear masks and reminds the staff to maintain proper hygiene. When asked about the table they presented about how they planned for the budgets for the fiscal year etc., CEO could not answer the question and stated “I just sign what they asked me to sign.” When asked about what they discussed during the governing body minutes, they could not state anything else. When both was asked when they have reviewed the agency’s policies and procedure, both CEO and ADM stated they were unable to review their policies and procedures which they stated to they were supposed to do annually. A review of the HHA’s document titled “Committee Meeting” dated 1/23/2023 , presided by the ADM indicated this evaluation provides a systematic method for review of policies and practices of ENSURE HOME HEAL Administrative and clinical policies are reviewed and signed annually. TH CARE, INC. to determine the extent to which patient care is appropriate, adequate, effective, and efficient, and for an overall policy and administrative review. It will provide for accountability, identification of needs in the program and an indication of areas in need of change. Topic: Organization: Purpose: To provide appropriate legal services and communicate the structure and lines of authority, responsibility and accountability. Administrative and clinical policies are reviewed and signed annually. Written policies on how policy and procedures are written, approved and reviewed. A review of the HHA’s undated policy titled “Position: Administrator” indicated The administrator must be a professional registered nurse or licensed physician, either of whom must be licensed in this State, or a person with training or experience in health administration. The administrator must have at least 1 year of supervisory or administrative experience in a field related to health. The administrator shall represent the governing body in the daily operation of the agency. His responsibilities include: Keeping the governing body fully informed of the conduct of the agency through regularly written reports and by attendance at meetings of the governing body. Employing qualified personnel and arranging for their orientation and continuing education. Developing and implementing an accounting and reporting system that reflects the fiscal experience and financial position of the agency. Negotiating for services provided by contract in accordance with legal requirements and established policies of the agency. Holding periodic meetings to maintain a liaison between the governing body, the advisory groups and the members of the staff. Other duties as may be assigned.”

“All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This Element is not met as evidenced by: Based on observation, interview, and record review, the home health agency failed to document all patient care orders in the clinical records for one out of seven sampled Patients (Patient 4). This failure had the potential to delay necessary care and treatment and to address patient’s needs. A review of Patient 4’s document titled “Home Health Certification and Plan of Care” on 2/25/2024 for the certification period of 1/12/2024 to 3/11/2024, indicated that Patient 4 was admitted on 1/12/2024 with the medical diagnosis of bilateral primary osteoarthritis (inflammation of the joints), angina pectoris (squeezing, pressure, heaviness, tightness or pain in the chest), mild intermittent asthma (a chronic condition that inflames and narrows the airways in the lungs), and cataract (a medical condition in which the lens [a clear, curved structure at the front of the eye] of the eye becomes cloudy which causing impaired vision) of the left eye. The record also indicated Skilled Nursing (SN) visit once a week for nine weeks to certify for comprehensive skilled nursing assessment, … and therapeutic response and compliance to prescribed medication/diet regimen. SN to assess pain level using pain scale, with 7-10/10 being severe (numeric pain scale to describe person’s pain level zero ten, zero indicates no pain, ten indicates severe pain) and implement pain relief measures and evaluate its effectiveness. The record indicated intervention to assess patient’s home environment for safety and sanitation hazards and identify risks and hazards. On 2/24/2024, during a joint home visit at 10:15 a.m., with the Director of Nursing (DON) at Patient 4’s independent living home, observed that the home was under renovation. DON stated that upon her arrival she spoke to the owner’s son and the son stated that the independent living was under renovation and that the patients were all moved out to a different location two weeks ago. Patient 4’s current address was not updated in the electronic medical record. On 2/24/2024, at 10:40 a.m., upon arrival at the new home address of Patient 4, observed furniture, boxes and other home furnishings were disorganized and scattered in the living room and hallway. Inside the Patient 4’s room noted there was one stair step down going into her bedroom. During an interview and observation with Patient 4 on 2/24/2024 at 11:30 a.m., Patient 4 stated that she has new medications prescribed by her primary medical doctor (PMD). Patient 4 stated that she went to the urgent care on 2/13/2024 due to difficulty of breathing. Patient 4 further stated that she had a telehealth (video visit) visit with PMD for her lower abdominal pain due to urinary tract infection on 2/21/24. During a review of Patient 4’s medications on hand, Patient 4 presented a subcutaneous injectable medication named Environmental Mix Cat/Dog (a medication to boost immune system to help with allergies) and stated that she is taking this medication every Friday prescribed by her primary doctor since June 2023. Patient 4 stated that she was tested for allergies for complaints of severe skin itching. Observed Patient 4 had unopened bottle of Pyridium (a medication to relieve symptoms caused by the urinary tract infections and urinary problems) medication dated 2/13/2024 for urinary tract infection. Patient 4 added that she received inhaler (a device used to push the medication into the lungs) for her shortness of breath. During a concurrent interview and record review on 2/24/2024 at 11:30 a.m., review of the discharge summary from urgent care dated 2/13/2024 and provided by Patient 4, indicated new treatment for Patient 4 such as inhaler (a device that delivers medication directly to the lungs), nebulizer treatment (a machine that turns liquid medicine into a mist that can be easily inhaled), prednisone (a medication to decrease inflammation) and Zithromax (an antibiotic to treat infection). Patient 4 stated that her roommate helps her refill her medication box because she cannot see clearly due to cataract and needs surgery to see clearly. Patient 4 further stated, “I’ve been waiting and waiting but I have no way of getting in touch with them.” Patient 4 stated her primary doctor is not the one listed on the plan of care. Patient 4 further stated that she does not know or have met the doctor indicated in her records. Patient 4 further stated that she has subcutaneous injectable medication that was administered by her roommate who is also an elderly. A review of Patient 4’s HHA medication profile (a drug profile or written summary of all the medicines patient is taking regularly, including over-the-counter and complimentary medicines) indicated urgent care visit and new prescribed medications were not recorded in the Patient 4’s clinical record and in the agency medication profile. A review of Patient 4’s medication profile provided by the agency, indicated, Pyridium (a medication to relieve symptoms caused by the urinary tract infections and urinary problems) medication dated 2/13/2024 for urinary tract infection was not in Patient 4’s medication profile. During an interview with Patient 4’s Roommate (Roommate 1) on 2/24/2024 at 1:00 p.m., Roommate 1 stated that she manages the weekly pillbox for Patient 4 because Patient 4 could not see. Roommate 1 stated she is also administering the subcutaneous injectable medication (Environmental Mix Cat/Dog) to Patient 4 every Friday. During an interview with the Director of Nursing (DON) on 2/24/2024 at 1:30 p.m., DON stated that the nurse should check the medications every home visit and if there are changes, they should notify the agency. DON also stated that the visiting nurse should have reported this to the agency. DON stated that she was not aware that Patient 4 was prescribed an injectable medication Environmental Mix Cat/Dog, Pyridium 200 milligrams (mg, a unit of mass) one tablet three times a day for two days, Zithromax 250 mg one tablet daily for seven days and prednisone 50 mg one tablet daily for seven days. A review of Patient 4’s electronic medical record (EMR) indicated no documentation from the assigned visiting nurse in the Patient 4’s record for the month of February. Further review of the records indicated that the HHA had not conducted and documented a “30-day case summary” (an objective measurement of function in accordance with accepted professional standards of clinical practice enabling comparison of successive measurements to determine the effectiveness of therapy goals. These assessments “may include but are not limited to eating, swallowing, bathing, dressing, toileting, walking, climbing stairs, or using assistive devices, and mental and cognitive factors to fully examine the effectiveness of the current therapy). Patient 4’s EMR indicated that there were no doctor’s orders for the medications for urinary tract infection, asthma, and the subcutaneous injectable medication in the electronic medical record. A review of the HHA’s undated policy titled “Physician Notification of Changes in Care,” indicated… whenever the plan of care is changed, including services, frequencies, treatments, etc., the patient will be notified at the time of the visit. A review of the HHA’s undated policy titled “Coordination of Services with other Providers Policy No 2-035.1,” indicated the purpose of the policy is to ensure the coordination of services provided by the organization and by other service providers… All activities are documented in the client’s clinical record on the appropriate form (care coordination form or visit notes). A review of the HHA’s undated policy titled “Position: Administrator” indicated the administrator … Assures compliance with federal/state regulations governing home health care services. A review of the HHA’s undated policy titled “Position: Director Of patient Care Services” (DPCS), indicated DPCS is responsible for direction of all home health clinical services… Plans, directs, coordinates, and monitors the delivery of all direct and indirect services to Agency home care clients… Assures clinical records are maintained in compliance with state and federal laws including Medicare.”

“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 observation, interview, and record review, the home health agency (HHA,) failed to provide care and services to two of seven sampled patients (Patients 1 and 4). For Patient 1, the visiting nurse failed to provide wound care as ordered. This deficient practice placed the patient’s wound to have slow healing. For Patient 4, who had visual impairment, as ordered by the primary physician. a. The home health agency’s visiting nurse did not identify all current medications prescribed by Patient 4’s primary medical doctor (PMD). b. Licensed Vocational Nurse (LVN 1) 1 failed to identify and verify that Patient 4 received Environmental mix Cat & Dog vials subcutaneous injection (the injection given in the fatty tissue, just under the skin) every week, from 6/2023 to 2/23/2024, that was administered by Patient 4’s roommate without training received from the home health agency and without the knowledge of the primary home health physician. These deficient practices resulted in Patient 4 not receiving prescribed medication and placed Patient 4 at high risk to experience undetected serious complication from injection, that included, infection on the injection site and gangrene (death of body tissue due to a lack of blood flow or a serious bacterial infection). On 2/24/2024 at 7:52 p.m., the Department called an Immediate Jeopardy (IJ, a situation in which the facility’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient), was identified in the presence of the agency’s Director of Nursing Designee (DOND) for the agency’s failure to provide services and administer medication as ordered by the physician. On 2/25/2024 at 1:30 p.m., the home health agency submitted an IJ Removal Plan (agency’s plan of action to correct the deficient practice) to the survey team. The survey team reviewed the IJ Removal Plan and notified the home health agency the IJ Removal Plan was not acceptable. The survey team informed the home health agency, that the IJ Removal Plan was not accepted and requested to submit acceptable IJ removal plan. On 2/25/2024, the survey team completed the survey tasks and exited the facility with the IJ situation not removed. On 3/12/2024 at 10:46 p.m., the agency submitted an IJ removal plan via email. On 3/13/2024 the survey team reviewed and accepted the IJ removal plan below: On 3/12/2024 at 10:46 p.m., the agency submitted an IJ removal plan via email. On 3/13/2024 the survey team reviewed and accepted the IJ removal plan below: 1). Corrective Action: a) Patients found affected by the deficient practice. Patient #4 medication profile was reviewed on 02/22/2024 with Primary Medical Doctor. The subcutaneous injection (injection given in the fatty tissue just under the skin) for Environmental mix Cat & Dog vials that were administered by Patient 4’s roommate was held as of PMD orders on 02/25/2024. RN clarified dosage, indication, route and frequency of Environmental Mix/ Cat & Dog subcutaneous injection on 02/28/2024 with PMD’s office. On 02/29/2024, DPCS verified with PMD’s office to discontinue Environmental Mix/ Cat & Dog subcutaneous injection per PMD’s orders. In service training and education of LVN 1 and RN supervisor of Patient #4 completed by the Director of Patient Care Services (DPCS) during in service training and education for the Agency done on 02/28/2024. LVN 1 and RN completed counseling with DPCS on 03/05/2024 for administration of injectable medications, patients not taking prescribed medications as ordered, and identifying current patient location. b) Other patients having the potential to be affected by this deficient practice. All patients have the potential to be affected by this deficient practice. 2) Measures/Systemic Changes to Ensure Deficient Practice Will Not Recur: a) The DPCS conducted a mandatory in-service education to all staff on 02/28/2024 to emphasize that he Agency must be able to meet the medical, nursing, rehabilitative and social needs of the patient in his or her place of residence. Each patient must have an individualized plan of care that specifies the care, disciplines, and services necessary to meet the patient specific needs as identified in the comprehensive assessment. This written plan of care should include measurable outcomes that evaluate the implementation and coordination of the interventions, instructions or education and training of the patient or caregiver. In service training also completed on 03/06/2024. 3) Plan Facility Developed to Ensure Deficient Practice Will Not Recur and Correction is Achieved and Sustained a) An unannounced supervisory visit will be conducted by the DPCS and nursing supervisors to ‘all active patients weekly x 3 months. Threshold is 100%. Once the threshold is met, the supervisory visits will be done monthly to ensure that each patient has a written individualized plan of care that outlines the services, disciplines and services necessary to meet the needs of the patient as identified in the comprehensive assessment. The plan of care must also outline the measurable outcomes to evaluate the implementation and coordination of the interventions, instructions or education and training of the patient or caregiver. b) A medical record review will be conducted by the DPCS on all active patients weekly x 3 months. Threshold is 100%. Once the threshold is met, the review will be conducted monthly to ensure that each patient has an individualized plan of care that outlines the care, disciplines, and services necessary to meet the needs of the patient as identified in the comprehensive assessment. The plan of care must also outline the measurable outcomes to evaluate the implementation and coordination of the interventions, instructions, or education and training of the patient and caregiver. c) A QI indicator was developed by the DPCS and the DPCS is responsible for the indicator to be used to all patients to ensure that all active patients have a written, individualized plan of care that outlines the care, disciplines and services necessary to meet the needs of the patient, as identified in the comprehensive assessment. The plan of care must also outline the measurable outcomes to evaluate the implementation and coordination of the interventions, instructions or education and training of the patient and caregiver. d} The data from the QI indicator is being collected, aggregated and analyzed quarterly by the DPCS. The results of the QI indicator is presented by the DPCS and reviewed by the QAPI Committee to e) The results of the QAPI meetings are presented to the Governing Body in their annual meetings. f) This will be a standing agenda in the monthly leadership meetings to ensure continued monitoring and compliance. g) The DPCS is responsible In the communication, Implementation, and monitoring of the plan of correction to ensure compliance. These policies and procedures will be reemphasized to all new hires and contracted personnel; on every personnel performance evaluation; contractual evaluation; and monthly in-service education and training. The survey team conducted an onsite verification of the IJ removal plan on 3/14/2023. The IJ was removed through onsite verification of the IJ removal plan implementation on 3/14/2024 at 1:19 p.m., in the presence of the agency’s Administrator, Registered Nurse and office clerk. A review of Patient 4’s “Home Health Certification and Plan of Care” on 2/25/2024 for the certification period from 1/12/2024 to 3/11/2024, indicated that Patient 4 was admitted on 1/12/2024 with the medical diagnosis of bilateral primary osteoarthritis (inflammation of the joints), angina pectoris (squeezing, pressure, heaviness, tightness or pain in the chest) and mild intermittent asthma (a chronic condition that inflames and narrows the airways in the lungs). The Home Health Certification and Plan of Care indicated Skilled Nursing (SN) visit once a week for nine weeks. Certify for comprehensive skilled nursing assessment, observation, and evaluation included therapeutic response and compliance to prescribed medication/diet regimen. During a joint home visit on 2/24/2024 at 10:15 a.m., with the Director of Nursing (DON) at Patient 4’s independent living home, Patient 4’s independent living home was under renovation. DON stated that the independent living was under renovation and that all patients moved out to a different location two weeks ago. During a joint home visit on 2/24/2024 at 10:40 a.m., with the DON at the new address, observed Patient 4 inside her room with her roommate. Observed Patient 4, alert and oriented to name, place and person and denied pain. Patient 4 was observed with visually impairment (was reading half an inch away from her face and the paper). During an interview on 2/24/2024 at 11:30 a.m., with Patient 4, Patient 4 stated that she has new medication prescribed by her PMD. Patient 4 stated that she had a telehealth (video visits) visit with PMD for her abdominal pain due to urinary tract infection on 2/21/24. Patient 4 presented a box of medication named Environmental Mix Cat/Dog injection (no indication written on the box) and that she was taking every Friday prescribed by her PMD since June 2023, for allergies and for complaints of severe skin itching. Patient 4 stated that she was unable to see and administer the medication herself, and her roommate administered the Environmental Mix Cat/Dog injection for her. Observed Patient 4 had unopened bottle of Pyridium (a medication to relieve symptoms caused by the urinary tract infections and urinary problems) medication dated 2/13/2024 for urinary tract infection. Further review of medications indicated that Patient 4 had a weekly medication planner in braille (a form of written language for blind people, in which characters are represented by patterns of raised dots that are felt with the fingertips). Patient 4 stated that she did not know how to read braille. Patient 4 stated that her roommate would help manage her weekly medication pill box (plastic container with days printed storage for daily medication). Patient 4 stated she received inhaler (a device used to push the medication into the lungs) for her shortness of breath. Patient 4 stated that her PMD was not the listed on the agency’s record and she did not know and not met the doctor from home health agency. During a review of Patient 4’s medications on 2/24/2024 at 12:00 p.m., with the DON, the following medication discrepancies were noted and were not on Patient 4’s current medication list. 1. Ezetimibe 10 milligrams (mg-unit of measurement) 1 tablet daily for high cholesterol started on 1/26/2024 2. Ranexa 500 mg 2 tabs daily for chest pain started on 1/26/2024 3. Vascepa 1 gram (gm- unit of measurement equals to 1000mg) 2 tablets twice a day for high cholesterol. 4. Oxybutynin 10 mg 1 tablet daily for overactive bladder started on 1/26/2024 5. Pyridium 200 mg 1 tablet three times a day for 2 days for UTI supposed to be started on 2/21/2024 and the bottle was still full. 6. Zithromax 250 mg packet 1 tablet once a day for 7 days for upper respiratory tract infection and prescribed last 2/13/2024 from urgent care, no bottle seen 7. Prednisone 50 mg 1 tablet daily for 7 days for asthma prescribed last 2/13/2024 from urgent care, no medication bottle observed. 8. Environmental Mix Vials 7 vials /Cat and Dog with a handwritten date of June 2023 given subcutaneously. There was no dose and frequency written on the box, but it was prescribed by Patient 4’s primary physician and Patient 4 takes it every Friday. Seven (7) vials had no seals, and six (6) vials were clear in color and one (1) vial was amber in color. 9. Vitamin D3 50000 IU once a week, not on the list and Patient 4 stated she takes it every Monday and was not listed on the medication profile. 10. Ibuprofen 600 mg was changed last 12/1/23 as needed for pain on the bottle at patient’s home was 400 mg. 11. Albuterol 90 mcg inhaler, inhale 2 puffs by mouth, as needed for shortness of breath, and was not listed in the medication profile 12. Albuterol 2.5 mg/3ml nebulizing solution every 6 hours as needed for asthma symptoms and was not listed in the medication profile. During an interview on 2/24/2024 at 1:00 p.m., with the board and care’s caregiver, the board and care’s caregiver stated that the board and care did not take care of the patient’s medications. The board and care’s caregiver stated that she works there four times a week but was never trained to administer or keep the medications for their patients. Caregiver stated that the patients keep their own medications inside their rooms. During an interview on 2/24/2024 at 1:00 p.m., with Patient 4’s Roommate (Roommate 1), Roommate 1 stated that she managed the weekly medication pill box for Patient 4, because Patient 4 could not see. Roommate 1 stated, she administered Patient 4’s Environmental Mix Cat/Dog via injection to every Friday. When asked how much subcutaneous injection medication she administered to the Patient 4, Roommate 1 stated, “There were lines in the injection, and they (unknown) told me to get the medicine up to this line only (demonstrating the line on the small syringe [1 cubic centimeter syringe] and give it to her”. When asked how much medication was on line, Roommate 1 stated, “No, but I was a former doctor in the Philippines, so I know what I am doing.” When asked if she was instructed how to give the injectable, roommate stated, “A person (unknown) came here to deliver the medications and he taught me how to give the medicine.” When asked Roommate 1 if the person who delivered was the doctor, she stated, “I don’t know.” During an interview on 2/24/2024 at 1:00 p.m., with Patient 4’s roommate, Patient 4’s roommate, stated that a doctor came and told her to give the injectable medication to the patient. Patient 4’s roommate stated that she was a former doctor in the Philippines. When she was asked if someone trained her to give the injectable medication, the roommate did not answer. During an interview on 2/24/2024 at 1:30 p.m., with the DON, the DON stated that the nurse should checked the medications every home visit and if there are changes, they should notify the agency. DON stated that the caregivers should take care of the medications instead of the patient who cannot see and not the roommate. DON also stated that the visiting nurse should have reported this to the agency. There was no policy and procedure were provided by the agency’s staff. During an attempted telephone call on 2/27/2023 at 11:46 a.m., with Patient 4’s Primary Medical Doctor (PMD), PMD was unavailable. Office staff (OS 1) stated that the PMD conducted an allergy test for Patient 4 and on 8/20/2023. OS 1 stated Patient 4 was tested positive for multiple allergies. OS 1 stated PMD prescribed an “immunity kit” also called “Environmental Mix Cat/Dog” to help to boost Patient 4’s immunity to help with her allergies. OS 1 stated Environmental Mix Cat/Dog was delivered to Patient 4’s home by the mobile driver/phlebotomist (a medical professional who’s trained to perform blood draws) and taught Patient 4 how to administer the medication. When asked if the phlebotomist and the PMD knew that Patient 4 is unable to see and administer her own medication, the OS 1 stated, “I do not know.” When asked about how much dose and how frequent the medication should be taken, OS 1 stated “I am not licensed to tell you further information about the medication and a nurse practitioner would call for the correct prescription, but did not received any call back. A review of the HHA’s undated policy titled “ Coordination of Care Policy No. 2-060.2” indicated that the case management and monitoring are accomplished on a consistent basis through home visits, telephone contacts and care coordination to ensure the delivery of quality of care to the client. All activities are documented in the client’s clinical record on the appropriate form (care coordination form or visit notes). The client, family, physician and all involved agency staff participate in case management activities and maintain liaison to assure that their efforts effectively complement one another and support the objectives outlined in the client’s plan of care. All services must coordinate with the agency nursing supervisor and/or DPCS about services being ordered and implemented and each service must provide documentation of what was performed within 7 days after the performance of the visit done. Home and community resources, in addition to those to those of the agency are utilized to the fullest in order to ensure coordination of care, thus providing the client with the most comprehensive home health care plan possible. A review of Patient 1’s admission record indicated Patient 1 was admitted to the facility on 2/13/24, with diagnoses that included hypertensive heart disease (a constellation of changes in the left ventricle, left atrium and coronary arteries as a result of chronic blood pressure elevation). A review of Patient 1’s plan of care (POC) from 2/13/24 to 4/12/24, included a SN (skilled nurse) frequency visits of twice a week for 9 weeks, to observe/assess all body systems focusing on integumentary (skin) system. One of the SN intervention is to provide wound care at left mid foot amputation as follows: to cleanse with Normal Saline, apply Santyl ointment, cover with 4x4 dressing with gauze, Kerlix wrap and Ace bandage twice a week. A review of Patient 1’s Comprehensive Adult Nursing Assessment (OASIS-to determine the need for nursing services) dated 2/13/24, indicated the patient had an open wound at left mid foot amputation. However, there was no documented evidence a wound care was provided during the initial visit. On 2/25/24, at 12 p.m., during an interview with the DPCS, she stated the visiting nurse provided wound care but it was not documented. A review of the undated agency’s policy and procedure titled, “Plan of Care,” indicated, “ ...The Plan of Care will serve as a physician’s orders for patient care and all staff providing services will be in compliance with and follow the MD (Medical Doctor) orders ...””

“Documentation of inservice training CFR(s): 484.80(d)(2) The HHA must maintain documentation that demonstrates the requirements of this standard have been met. This Element is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to ensure a home health aide receive at least 12 hours of in-service training during each 12-month period and in-services provided to all the clinical staff. This deficient practice had the potential to jeopardize the patient’s safety and security due to the staff’s lack of training. During the recertification survey on 2/25/2024 at 2 p.m., a request was made to the Human Resource Manager to review the in-service training being provided for the licensed staff including certified home health aide (CHHA) staff. HR manager showed their binder for the CHHA staff in-service and indicated that all lesson plans only and no in-services conducted to the licensed staff and CHHA. During an interview with the HR manager on 2/25/2024 at 2 p.m., HR manager, stated that they outsource their CHHA from a nursing group and the nursing group provides the in-services for their own staff. The HR manager could not provide documented evidence of staff in-services. A review of the HHA’s undated policy titled “Position: Administrator” indicated Ensures development of relationships and contractual agreements with third-party payers, other vendors, and the business community. Assures compliance with contracts/agreements. Participates in the hiring, orientation, and development of management staff. Directs daily business activities of the Agency and assures development of systems that support recruitment, hiring and the ongoing professional development of Agency staff. A review of the undated HHA’s policy and procedure titled “ indicated regularly scheduled and appropriate in-service programs will be made available for all employees to ensure continuing education of all agency personnel.”