Every finding on record at Saint Elizabeth at Home Corp

A Federal re-certification and State Licensure survey was completed for this agency from 9/9/2024 through 9/11/2024. Condition level deficiencies were identified.

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: This Element is NOT MET as evidenced by: Based on record review and staff interview, it has been determined that the Agency failed to ensure that each patient receives the home health services that are written in the plan of care for 5 of 7 care plans reviewed, Patient ID#s 1, 2, 4, 5, and 7. Findings are as follows: 1. Record review for Patient ID #1 revealed his/her start of care date was 6/9/2024 and s/he had diagnoses, including but not limited to, encounter for orthopedic aftercare and difficulty walking. Review of the physician orders revealed the following: - Starting 6/9/2024: Skilled Nursing (SN) services 1-2 times per week for 9 weeks - Starting 8/8/2024: Physical Therapy (PT) services 1-2 times per week for 9 weeks Review of the services rendered revealed a missed SN visit on 7/31/2024 and a PT visit on 8/9/2024. Further review of the record lacked documentation of attempts to reschedule the missed visits or that the physician was notified. 2. Record review for Patient ID #2 revealed his/her start of care date was 8/23/2024 and s/he has diagnoses including, but not limited to, Parkinson’s disease and encounter for change or removal of nonsurgical wound dressing. Review of the physician orders revealed the following: - Starting 8/25/2024: Skilled Nursing (SN) services 1-2 times per week for 9 weeks - Starting 9/1/2024: Occupational Therapy (OT) services 1-2 times per week for 8 weeks Review of the services rendered revealed a missed SN and OT visit on 9/5/2024. Further review of the record lacked documentation of attempts to reschedule the missed visits or that the physician was notified of the missed OT visit. 3. Record review for Patient ID #4 revealed his/her start of care date was 5/18/2024 and s/he has diagnoses including, but not limited to, hemiplegia and congestive heart failure. Review of the physician orders revealed the following: - Starting 5/20/2024: Occupational Therapy (OT) 1-2 times a week for 9 weeks - Starting 5/20/2024: Physical therapy (PT) 1-2 times a week for 9 weeks Review of the services rendered revealed a PT visit was missed on 7/8/2024 and OT visits were missed on the following dates: -5/28/2024 -5/29/2024 -7/5/2024 Additionally, the patient did not receive OT services for 1 of 9 weeks, between 5/26/2024 and 6/1/2024. Further review of the record lacked documentation of attempts to reschedule the above-mentioned visits or that the physician was notified of the missed OT visits. 4. Record review for Patient ID #5 revealed his/her start of care date was 6/11/2024 and s/he had diagnoses, including but not limited to, normal pressure hydrocephalus (an abnormal buildup of cerebrospinal fluid in the brain), weakness, and gait abnormality. Review of the physician orders revealed that starting 8/10/2024 s/he was ordered to receive PT services 1-2 times per week for 8 weeks. Review of the services rendered revealed PT visits were missed on the following dates: - 7/10/2024 - 7/25/2024 - 7/31/2024 - 8/14/2024 - 8/27/2024 Further review of the record lacked documentation of attempts to reschedule the above-mentioned missed visits or that the physician was notified. 5. Record review for Patient ID #7 revealed his/her start of care date was 6/28/2024 and s/he had diagnoses, including but not limited to, non-surgical dressing and orthopedic aftercare. Review of the physician orders revealed that s/he was ordered to receive Home Health Aide (HHA) services 1-2 times per week for 8 weeks. Review of the services rendered revealed HHA visits were missed on 7/25/2024 and 9/6/2024. Additionally, the Patient did not receive HHA services for 2 of 9 weeks, between 8/18/2024 through 8/31/2024. Further review of the record lacked documentation of attempts to reschedule the above-mentioned missed visits or that the physician was notified. During a surveyor interview with Staff L on 9/11/2024 at approximately 5:00 PM, she acknowledged that the above-mentioned ordered visits were missed, not rescheduled, and the Patient’s physicians were not notified, as required.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: This Element is NOT MET as evidenced by: Based on record review and staff interview, it has been determined the Agency failed to ensure the QAPI program is data-driven, involves all services, and is reviewed by the governing body. Findings are as follows: Review of the HHA QAPI documentation and plan for 2023 failed to reveal evidence as to identify how the HHA is collecting data, monitoring the data collected, measuring the outcomes to that data, and tracking performance to ensure the interventions implemented are effective in assisting the HHA in realizing the desired outcomes, and the improvements are sustained. In addition, the documentation lacked evidence that the governing body approved the frequency in which the HHA is collecting data and reviewing the QAPI program and performance improvement plans. Review of a schedule for the HHA 2023 governing body meetings revealed meetings were held on the following dates: 2/13/2023, 4/10/2023, 6/12/2023, 8/21/2023, 11/27/2023, and 12/11/2023. Review of the agenda and minutes to the above-mentioned meetings lacked evidence of information related to the HHA QAPI program and the designated 2023 performance improvement plans. During a surveyor interview on 9/11/2024 at 3:05 PM with the Quality Improvement Manager, Registered Nurse, Staff M, she revealed that she is the designated chair for QAPI and revealed that she was not aware the governing body had to review the QAPI program and approve the frequency of the collection of data used for the QAPI program indicators. Additionally, Staff M acknowledged that the HHA QAPI program did not involve all services offered and provided by the HHA and revealed that she was not aware of this regulatory requirement. During a surveyor interview on 9/11/2024 at 6:00 PM with the Administrator, Clinical Director, QI Manager, Clinical Manager, and HR Manager, they were unable to provide evidence that the HHA QAPI program includes all services and is reviewed by the governing body, as required.

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: This Element is NOT MET as evidenced by: Based on record review and staff interview, it has been determined that the Agency failed to ensure the QAPI program includes infectious and communicable diseases and measures the collected data to evaluate procedures, interventions for measurement, and analysis of indicators, that includes the frequency with which such measurement analysis will occur. Findings are as follows: Review of the QAPI documentation provided to the surveyors failed to reveal evidence of procedures related to measuring, tracking, and analyzing. Additionally, the QAPI program lacked evidence of infectious and communicable diseases as being an integral part. During a surveyor interview on 9/11/2024 at 3:05 PM, with the Quality Improvement Manager, Registered Nurse, Staff M, she acknowledged that the QAPI program did not have infectious and communicable diseases as an integral part. During a surveyor interview on 9/11/2024 at 6:00 PM with the Administrator, Clinical Director, QI Manager, Clinical Manager, and HR Manager, they were unable to provide evidence that the HHA QAPI program includes the above-mentioned components, as required.

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: This Element is NOT MET as evidenced by: Based on record review and staff interview, it has been determined that the Agency failed to ensure the frequency and detail of the data collection must be approved by the HHA’s governing body. Findings are as follows: Review of the QAPI documentation failed to reveal documentation related to the frequency of data collection. Review of the agenda and minutes of the scheduled meetings for those meetings conducted by the governing body lacked evidence that the frequency and detail of the data collection was approved by the governing body. During a surveyor interview on 9/11/2024 at 3:05 PM with the QI Manager, Registered Nurse Staff M, she acknowledged that the governing body did not approve the frequency and detail of the data collection for QAPI and indicated she was not aware of this regulatory requirement. Additionally, Staff M was unable to reveal how the program functions specific to which indicators/measures are being tracked, at what intervals, and how the information will be used by the HHA to improve quality and safety. During a surveyor interview on 9/11/2024 at 6:00 PM with the Administrator, Clinical Director, QI Manager, Clinical Manager, and HR Manager, they were unable to provide evidence of the above-mentioned criteria, as required.

Improvements are sustained CFR(s): 484.65(c)(3) The HHA must take actions aimed at performance improvement, and, after implementing those actions, the HHA must measure its success and track performance to ensure that improvements are sustained. This ELEMENT is not met as evidenced by: This Element is NOT MET as evidenced by: Based on record review and staff interview, it has been determined that the Agency failed to measure its success and track performance to ensure the improvements implemented in QAPI are sustained. Findings are as follows: Review of the QAPI information failed to reveal evidence of a systemic procedure related to tracking performance of interventions and improvements that includes a specific frequency and duration. During a surveyor interview on 9/11/2024 at 3:05 PM with the QI Manager, Registered Nurse Staff M, she acknowledged that the QAPI program failed to include tracking performance of interventions and improvements that specifies frequency and duration. During a surveyor interview on 9/11/2024 at 6:00 PM with the Administrator, Clinical Director, QI Manager, Clinical Manager, and HR Manager, they were unable to provide evidence of the above-mentioned criteria, as required.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: This Element is NOT MET as evidenced by: Based on record review and staff interview, it has been determined that the HHA’s governing body failed to review QAPI and assume overall responsibility for ensuring that the QAPI program reflects the complexity of the HHA and its services, involves all services, focuses on indicators related to improved outcomes, and takes actions that address the HHA’s performance across the spectrum of care. Findings are as follows: Review of a schedule for the HHA 2023 governing body meetings revealed meetings were held on the following dates: 2/13/2023, 4/10/2023, 6/12/2023, 8/21/2023, 11/27/2023, and 12/11/2023. Review of the agenda and minutes to the above-mentioned meetings lacked evidence of information related to the QAPI program and the designated 2023 performance improvement plans. During a surveyor interview on 9/11/2024 at 3:05 PM with the Quality Improvement Manager, Registered Nurse, Staff M, she acknowledged that she was unaware of the regulatory requirement specific to need for the governing body to review QAPI and approve the frequency and detail of data collection and was unable to provide evidence that the HHA’s governing body reviewed the QAPI and performance improvement plans. During a surveyor interview on 9/11/2024 at 6:00 PM with the Administrator, Clinical Director, QI Manager, Clinical Manager, and HR Manager, they were unable to provide evidence that the HHA’s governing body reviewed the QAPI program, approved the frequency and detail of data collection and therefore, were unable to provide evidence that the HHA’s governing body fulfilled their executive responsibilities related to the above, as required.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: This Element is NOT MET as evidenced by: Based on record review and staff interview, it has been determined that the HHA’s governing body failed to review QAPI and assume overall responsibility for ensuring that the QAPI program reflects the complexity of the HHA and its services, involves all services, focuses on indicators related to improved outcomes, and takes actions that address the HHA’s performance across the spectrum of care. Findings are as follows: Review of the QAPI documentation provided to the surveyors failed to reveal evidence of infectious and communicable diseases as being an integral part of the HHA's quality assessment and performance improvement (QAPI) program. During a surveyor interview on 9/11/2024 at 3:05 PM, with the Quality Improvement Manager, Registered Nurse, Staff M, she acknowledged that the QAPI program did not have infectious and communicable diseases as an integral part of the HHA's quality assessment and performance improvement (QAPI) program. During a surveyor interview on 9/11/2024 at 6:00 PM with the Administrator, Clinical Director, QI Manager, Clinical Manager, and HR Manager, they were unable to provide evidence that the HHA QAPI program includes the above-mentioned components, as required.

Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This ELEMENT is not met as evidenced by: This Element is NOT MET as evidenced by: Based on record review and staff interview, it has been determined that the Agency failed to ensure that nursing communicated with the physician involved in the plan of care for 1 of 2 patients reviewed relative to surgical wound orders, Patient ID #8. Findings are as follows: Review of the Agency’s grievance log documentation revealed that the patient reported to Staff L, the Clinical Manager, on 2/27/2024 that s/he does not want the nurse, Registered Nurse Staff N, to continue to visit him/her and that the nurse did not completely remove a suture. Further review of the documentation revealed Staff N reported to Staff L, in part the following: “…she knew patient was going to MD appointment and knew she should not pick at embedded suture…” Review of the patient record revealed s/he was admitted to services on 2/2/2024 with diagnoses including but not limited to surgical aftercare following surgery on the respiratory system. Review of the record revealed Staff N received a verbal order from the physician on 2/15/2024 for the skilled nurse to remove the suture to the patient’s right chest tube site. Review of a document titled, “Skilled Nursing Visit Note” dated 2/16/2024, revealed Staff N documented that she removed the suture to the chest tube site as ordered and the patient has an appointment with the surgeon on 2/20/2024. Further review of this document revealed the physician was notified of the visit but did not indicate what information was communicated or if a response was received from the physician. Additional review of the record lacked evidence that the embedded suture was reported to the physician. During a surveyor interview with Staff L on 9/11/2024 at approximately 5:00 PM, she acknowledged that the patient’s record did not include documentation of the embedded suture or that it was reported to the physician by Staff N. Furthermore, her expectation would be that the embedded sutures would have been reported to the surgeon and documented in the patient’s clinical record

Participate in the HHA's QAPI program; CFR(s): 484.75(b)(8) Participation in the HHA's QAPI program; and This ELEMENT is not met as evidenced by: This Element is NOT MET as evidenced by: Based on record review and staff interview, it has been determined that the QAPI program lacked evidence of having input and participation of every skilled professional which includes contribution with all phases of the HHA’s QAPI program. Findings are as follows: Review of the QAPI program lacked evidence of including the involvement and participation of all disciplines of the HHA’s professional staff. During a surveyor interview on 9/11/2024 at 3:05 PM, with the Quality Improvement Manager, Registered Nurse, Staff M, she acknowledged that the QAPI program did not include the involvement and participation of all professional staff and revealed that she was unaware of this regulatory requirement. During a surveyor interview on 9/11/2024 at 6:00 PM with the Administrator, Clinical Director, QI Manager, Clinical Manager, and HR Manager, they were unable to provide evidence that all professional staff were involved in the development of QAPI and have participated in the contribution of all phases of QAPI as indicated above, as required.

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: This Element is NOT MET as evidenced by: Based on staff interview it has been determined that the HHA failed to ensure the organizational structure, including lines of authority, responsibilities and relationships including services furnished is reflective accurately on the HHA organizational chart. Findings are as follows: Review of HHA organizational chart provided to the surveyors during the recertification survey revealed there to be two clinical managers designated to oversee the Clinical Case Managers and Home Health Aides. During a surveyor interview on 9/11/2024 at approximately 1:30 PM with Clinical Manager, Staff L, she revealed that she does not oversee the Home Health Aides for private duty assignment and referred us to the designated person who on the organizational chart is listed as the Private Duty Scheduler. During a surveyor interview on 9/11/2024 at approximately 1:45 PM with the HR Manager, she revealed the organizational chart is not accurate and requires updating. During a surveyor interview on 9/11/2024 at 6:00 PM with the Administrator, Clinical Director, QI Manager, Clinical Manager, and HR Manager, they were unable to provide evidence of an organizational chart that reflects accurate lines of authority, as required.

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: This Element is NOT MET as evidenced by: Based on record review and staff interview, it has been determined that the HHA failed to ensure the quality assessment and performance improvement program (QAPI) is reviewed by the governing body. Findings are as follows: Review of the HHA information related to QAPI lacked evidence that the governing body reviewed the QAPI program and approved the frequency and detail of the data collection for QAPI and the performance improvement plans. Review of a schedule for the HHA 2023 governing body meetings revealed meetings were held on the following dates: 2/13/2023, 4/10/2023, 6/12/2023, 8/21/2023, 11/27/2023, and 12/11/2023. Further review of the agenda and minutes to the above-mentioned meetings lacked evidence of information related to the HHA QAPI program and the designated 2023 performance improvement plans. During a surveyor interview on 9/11/2024 at 3:05 PM with the Quality Improvement Manager, Registered Nurse, Staff M, she was unable to provide evidence the governing body reviews the QAPI program and therefore, could not provide evidence they approved the frequency and detail of data collection for the QAPI program indicators. During a surveyor interview on 9/11/2024 at 6:00 PM with the Administrator, Clinical Director, QI Manager, Clinical Manager, and HR Manager, they were unable to provide evidence that the governing body reviews the HHA’s quality assessment and improvement performance program (QAPI), as required.

Ensures qualified pre-designated person CFR(s): 484.105(b)(2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section. This ELEMENT is not met as evidenced by: This Element is NOT MET as evidenced by: Based on record review and staff interview, it has been determined that the HHA failed to pre-designate a qualified, person who is authorized in writing by the Administrator and governing body to assume the same responsibilities and obligations as the Administrator when the Administrator is not available. Findings are as follows: Review of the HHA information provided to the surveyors during recertification survey, failed to reveal evidence of the above. During a surveyor interview on 9/11/2024 at 6:00 PM with the Administrator, Clinical Director, QI Manager, Clinical Manager, and HR Manager, they were unable to provide evidence of written approval by the Administrator and governing body that the HHA has a designated and qualified person to assume full responsibilities and obligations of the Administrator in her absence, as required.

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: This Element is NOT MET as evidenced by: Based on record review and staff interview, it has been determined that the Agency failed to ensure that information contained in the clinical record is accurate and adheres to current clinical record documentation standards of practice for 1 of 2 patients reviewed relative to surgical wound orders, Patient ID #8. Findings are as follows: Review of the policy titled, “Clinical Record Access and Entries”, states in part, “…All entries into the clinical record must be accurate and complete…” Review of the Agency’s grievance log documentation revealed that the patient reported to Staff L, the Clinical Manager, on 2/27/2024 that s/he does not want the nurse, Registered Nurse Staff N, to continue to visit him/her and that the nurse did not completely remove a suture. Further review of the documentation revealed Staff N reported to Staff L, in part the following: “…she knew patient was going to MD appointment and knew she should not pick at embedded suture…” Review of the patient record revealed s/he was admitted to services on 2/2/2024 with diagnoses including but not limited to surgical aftercare following surgery on the respiratory system. Review of the record revealed Staff N received a verbal order from the physician on 2/15/2024 for the skilled nurse to remove the suture to the patient’s right chest tube site. Review of a document titled, “Skilled Nursing Visit Note” dated 2/16/2024, revealed Staff N documented that she removed the suture to the chest tube site as ordered and the patient has an appointment with the surgeon on 2/20/2024. Further review of this document revealed the physician was notified of the visit but did not indicate what information was communicated or if a response was received from the physician. Additional review of the record lacked evidence that the embedded suture was reported to the physician. During a surveyor interview with Staff L on 9/11/2024 at approximately 5:00 PM, she acknowledged that the patient’s record did not include documentation of the embedded suture or that it was reported to the physician by Staff N. Furthermore, her expectation would be that the patient’s record be accurate, complete, and include this information.

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 record review, surveyor observations, and staff and client interview, it has been determined that the Home Health Agency has failed to complete a comprehensive assessment of all ordered medications the client is currently taking for 5 of 6 clients observed during home visits (ID #'s 1, 2, 3, 6, & 9). Findings are as follows: The agencies policy “Medication Reconciliation” revised 6/13/2017, states in part, “Policy: Medication Reconciliation will be performed by skilled staff upon admission to the agency, and at all transitions of care (i.e., Resumption of Care, Transfers, Discharges, after MD/clinic visits). Purpose: To ensure the safe and accurate assessment of the patient’s medications to prevent medication errors and ADE (Adverse Drug Events). Procedure: … The clinician will conduct a patient medication interview, with the patient and or family/caregivers as to which medications patient is taking and compare strength, dose, frequency, and route to the most recent list of medications received at referral. The admitting clinician will then compile a list of medications patient presently has in-home, including prescriptions, over the counter, herbal, vitamin, supplemental, and respiratory therapy-related medications. The clinician will then note any and all discrepancies and contact the Physician for clarification and confirmation of changes in dosage, frequency and /or route, as well as the addition of any new medications and /or discontinued meds. …The clinician will list all meds patient should be taking on the daily medication schedule form…. …The medication schedule will be updated on a continuous basis in order to ensure the patient is taking the correct medication at all points of care…” 1. During a home visit on 11/18/2021 with Nurse, Staff F and Client ID #1, a medication reconciliation was completed between the client's current medication list and the medications in the client's home. The current medications on the client’s initial 10/26/2021 through 12/24/2021 Home Health Certification and Plan of Care included the following: -Ondansetron Hydrochloride 4 mg (milligrams) oral tablet take 1 tab, every 6 hours as needed for nausea. -Polyethylene Glycol 3350 oral powder for reconstitution; administer 17 gm (grams) oral, once a day as needed for constipation. -Artificial Tears preserved ophthalmic solution; apply 1 drop ophthalmic 3 times a day in right eye. -Melatonin 3 mg oral tablet, one tablet by mouth once a day at bedtime as needed for sleep. During a surveyor visit with Staff F, to Client ID #1, the surveyor interviewed the client and his/her mother about the medication, they informed the surveyor that the client did not have prescriptions for the Ondansetron Hydrochloride, or the Polyethylene Glycol when discharged from the hospital. They had a prescription for the Melatonin but did not fill it as the client was sleeping too much so they did not use it. They have the artificial Tears; however, Client ID # 1 has not been using them. Additionally, they provided the surveyor with a bottle of Multivitamins that the client has been taking once a day since s/he came home, which is not on the client’s medication list or physicians’ orders. During an interview with Nurse, Staff F, during the visit, she was unaware of the above medications that the client was not taking and unaware that he was taking the multivitamin. She was unable to produce documentation that the client’s medications had been reconciled or that the physician was notified of the discrepancies. The surveyor interviewed the Clinical Director on 11/18/2021 at approximately 12:15 PM, who stated that the medications should have been reconciled at each visit and the physician contacted for any discrepancies. 2. During a home visit on 11/18/2021 with Nurse, Staff D and Client ID # 2, a medication reconciliation was completed between the client’s current medication list and the medications the client is taking in the home. Review of the client’s current medication orders, and medication list include the following. -Flonase 50 mcg(micrograms)/inh (inhaled) nasal spray, administer 1 spray in each nostril once a day, order date 10/6/2021 -Loratadine 10 mg oral tablet, take one tablet by mouth once a day at night, order date 10/6/2021 Review of the client’s 10/18/2021 through 12/26/2021 Home Health Certification and Plan of Care failed to include the orders for Flonase and Loratadine. During an interview with the client, ID # 2, s/he informed the surveyor that s/he does not take the Loratadine every day, s/he has only taken it a couple of times and that s/he does not use the Flonase nasal spray daily, Additionally, s/he provided the surveyor with a bottle of Multi vitamins which s/he takes daily and stated s/he has been taking them for a long time. The client also gave the surveyor a prescription dated 11/13/2021, for Amoxicillin 500mg, take 4 tablets one hour prior to dental appointments which she has taken prior to her recent dental appointment. During an interview with Nurse, Staff D, during the home visit, and she was unaware that the client was not taking the Flonase or the Loratadine daily as ordered, she was unaware the client had been taking a multivitamin, and she was unaware that the client had a prescription for Amoxicillin pre dental procedure and had taken it prior to her recent dental visit. She was unable to produce documentation that the client’s medications had been reconciled or that the physician was notified of any discrepancies. During an interview with the Clinical Director on 11/19/2021 at approximately 1:15 PM, she stated that the medications should have been reconciled at each visit and the physician contacted for any discrepancies. 3. During a home visit on 11/19/2021 with Nurse, Staff G and Client ID # 3, a medication reconciliation was completed between the client’s current medication list and the medications the client is taking in the home. Review of the client’s 11/3/2021 through 1/1/2022 Home Health Certification and Plan of Care and the client’s medication profile included an order for Lipoflavonoid Lipotropic with Multivitamins oral capsule, take one capsule by mouth once a day, may take 2 once a day and two at night PRN as directed by physician. During surveyor review of the medications in the home, the client stated that s/he did not have a prescription for the Lipoflavonoid Lipotropic with Multivitamins and was not aware that the medication was on the medication list, nor did s/he have any instructions from the physician as to taking this medication. During an interview with the Nurse, Staff G during the medication review, who stated she was unaware that the client did not have the medication and had not been taking it since s/he was admitted on 11/3/2021. During an interview with the Clinical Director on 11/18/2021 at approximately 2:20 PM, she stated that the medications should have been reconciled on admission and the physician contacted if the client did not have a prescription for the Lipoflavonoid Lipotropic with Multivitamins. She was unable to produce documentation that the physician had been contacted. 4. During a home visit on 11/18/2021 at 10:00 AM for Client ID #6 with Nurse, Staff E it was observed that the nurse failed to complete a medication reconciliation. When questioned about medications Staff E stated that the client “has not seen the doctor lately so there have been no changes.” The Assisted Living facility where the client resides handles the administration of medications. Review of the current medications on the client’s 10/18/2021 through 12/16/2021Home Health Care Certification and Plan of Care and current medications list, provided by the agency on 11/17/202, included the following orders: -Artificial tears 1 drop each eye daily. -Sinemet 25mg-100mg, take 2 tablets daily in the afternoon. -Fluorouracil topical 0.5 % apply 1 application daily to areas on face, scalp, arms, and head. “If red, scab, crusty, itchiness occurs, stop using.” The order has a start date of 11/4/2021. Surveyor review of the active orders as of 11/18/2021 from the Assisted Living Facility where the client resides revealed the following: -Artificial tears 1.4% 1 drop in both eyes as needed. This order had a start date of 6/4/2018. This order’s instructions did not match the order on the agency medication list. -Sinemet CR tablet extended release 25-100mg give 2 tablets in the afternoon. This order had a start date of 8/12/2021 and does not match the order on the agency medication list. -Sinemet 25-100mg give 1 tablet by mouth in the afternoon. This order had a start date of 8/12/2021 and was not present on the agency’s medication list. -Aldara Cream 5% to areas of scalp and face topically at bedtime every Monday and Thursday. This order had a start date of 5/23/2019 and was not present on the agency medication list. There was no active order for Fluorouracil topical on the assisted living list. During an interview on 11/19/2021 at 2:50 PM with the Clinical Director she acknowledged that the medication orders at the assisted living and the agency don’t match. She further revealed that the nurse is expected to reconcile the medications at each client visit. 5. A home visit was conducted on 11/19/2021 at approximately 11:00 AM for Client ID #9 with Occupational Therapist, Staff B. Review of the current medications on the client’s 10/16/2021 through 12/14/2021 Home Health Care Certification and Plan of Care and current medications list, provided by the agency on 11/18/202 failed to reveal an order for Imodium. Surveyor review of the active orders as of 11/19/2021 from the Assisted Living Facility where the client resides revealed an order with a start date of 10/22/2021 for Imodium 2mg tablet one tablet by mouth twice daily as needed for diarrhea. During an interview with the Clinical Director on 11/24/2021 at approximately 1:00 PM she acknowledged that the agency failed to have the order for Imodium on the clients list of medications. She further revealed that the medications should have been reconciled at each client visit.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on surveyor observation, record review and staff interview it was determined that the agency failed to ensure that drugs, services, and treatments are administered only as ordered by a physician for 4 out of 7 clients observed during home visits, Client ID #s 1, 2, 3 and 6. Findings are as follows: 1. Record review for Client ID # 1, revealed the current medications on the patients initial 10/26/2021 through 12/24/2021 Home Health Certification and Plan of Care included the following. Ondansetron Hydrochloride 4 mg (milligrams) oral tablet take 1 tab, every 6 hours as needed for nausea, Polyethylene Glycol 3350 oral powder for reconstitution; administer 17 gm (grams) oral, once a day as needed for constipation. During a surveyor interview with Client ID #1, s/he informed the surveyor that s/he did not have prescriptions for the Ondansetron Hydrochloride, or the Polyethylene Glycol when discharged from the hospital. During an Interview with Nurse, Staff F on 11/18/2021 at approximately 10:05 AM, she was unaware that the above client did not have the above medications that were ordered by the physician. She was unable to produce documentation that the client’s medications were being administered as ordered by the physician, or that the physician was notified of the discrepancies. The surveyor interviewed the Clinical Director on 11/18/2021 at approximately 12:15 PM, who stated that the physician’s orders for medications should have been followed and the nurse should have contacted the physician if the client did not have the medications. 2. Record review of Client ID # 2’s, Home Health Certification and Plan of Care, dated 10/18/2021 through 12/26/2021 failed to include the orders for Flonase and Loratadine. Review of the Medication profile revealed the following orders, for Flonase 50 mcg (micrograms)/inh (inhaled) nasal spray, administer 1 spray in each nostril once a day, order date 10/6/2021, and Loratadine 10 mg oral tablet, take one tablet by mouth once a day at night, order date 10/6/2021. Interview with Client, ID # 2, s/he informed the surveyor that s/he does not take the Loratadine every day, s/he has only taken it a couple of times and that s/he does not use the Flonase nasal spray daily. The surveyor interviewed Nurse, Staff D, on 11/18/2021 at approximately 2:15 PM, who was unaware that the client was not taking the Flonase or the Loratadine daily as ordered, she was unable to produce documentation that the physician’s orders were being followed. The surveyor interviewed the Clinical Director on 11/19/2021 at approximately 1:15 PM, who stated that the medications orders should have been reconciled during each visit and the physician contacted for any discrepancies. 3. Record review for Client ID # 3’s, initial Home Health Certification and Plan of Care, provided by the agency on 11/17/202, for the certification period dated 11/3/2021 through 1/1/2022 revealed the following medication order. Lipoflavonoid Lipotropic with Multivitamins oral capsule, take one capsule by mouth once a day, may take 2 once a day and two at night PRN as directed by physician, start date 11/3/2021 During surveyor review of the medications in the home, the client stated that s/he did not have a prescription for the Lipoflavonoid Lipotropic with Multivitamins and was not aware that the medication was on the medication list, nor did s/he have any instructions from the physician as to taking this medication. The surveyor interviewed Nurse, Staff G, on 11/19/2021 at approximately 10:05 AM, during the home visit, who stated she was unaware that the client did not have the medication and had not been taking it since s/he was admitted on 11/3/2021. During an interview with the Clinical Director on 11/18/2021 at approximately 2:20 PM, she stated that the medications should have been reconciled on admission and the physician contacted if the client did not have a prescription for the Lipoflavonoid Lipotropic with Multivitamins. She was unable to produce documentation that the physician had been contacted. 4. Record review for Client ID #6’s Home Health Certification and Plan of Care, provided by the agency on 11/17/2021, for the certification period dated 10/18/2021 through 12/16/2021 revealed the following orders: 1) “Wound care to biopsy site on left side of back-cleanse with NS (normal saline), apply Xeroform, cover with Allevyn 2x/week.” 2) Skilled Nursing; 2 times per week for 6 weeks with 2 prn (as needed) visits. Surveyor observation on 11/18/2021 at approximately 10:00 AM of the client’s dressing change by Staff E revealed that the dressing removed from the wound care site, and the new dressing applied did not contain the Xeroform as ordered. This was acknowledged by Staff E at the time of the dressing change. Review of schedule of visits revealed that only one skilled nursing visit was made during the week of November 7- November 13, 2021. Record review of verbal orders entered on 11/18/2021 after the home visit revealed the following: “Wound care cleanse with NS+ cover with Allevyn 1x/week and PRN until surgery. This order was not entered until 11/18/2021 but a start date was entered for 10/29/2021.“…Discontinue- effective 11/11/2021: Skilled Nursing; 2wk [ 2 visits per week] 6wk [for 6 weeks] 2 PRN [as needed] …skilled nursing for wound care biopsy site right mid scapula area 2x/week…” During an interview on 11/18/2021 at approximately 3:30 PM with the Clinical Director she acknowledged that at the time of the home visit the wound care order was cleanse with normal saline, apply Xeroform and cover with Allevyn. She further acknowledged that during the week of November 7- November 13, 2021 the client was scheduled for 2 skilled nursing visits a week but could not provide evidence that the second visit was completed. During a telephone interview on 11/18/2021 at 3:48 PM with the Nurse Manager, she acknowledged that the wound care order was added on 11/18/2021 not on 10/29/2021 as documented as the start date.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record review and staff interview, it has been determined that the Condition of Participation: Quality assessment and performance improvement has not been met relative to; the agency failed to develop, implement, and maintain an effective, ongoing HHA wide, data driven Quality Assessment and Performance Improvement (QAPI) program. Findings are as follows: Review of the agencies QAPI binder that was provided to the surveyor failed to contain a QAPI plan, which includes program objectives, organizations involved, oversight responsibilities, with a written plan of an active program that includes ongoing monitoring of quality. Additionally, the binder also lacked evidence of a Professional Advisory Committee (PAC) that met twice a year. During an interview on 11/23/2021 at 10:45 AM, with the Quality Improvement Nurse, she was unable to provide evidence of a QAPI program, or that the PAC had met twice a year. She stated that in September 2021, she met with the Administrator, and Clinical Director to discuss any issues since the absence of the QI in April of 2020. During an additional interview with the Administrator on 11/24/2021 at approximately 11:30 AM, she acknowledged that the agency did not have an active QAPI program, nor did the PAC meet.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on record review and staff interviews, it has been determined that the agency failed to meet the conditions of participation for skilled professional services, relative to medical social work services as required. Findings are as follows: During an interview with the Clinical Director on 11/19/2021 at 10:40 AM, she stated that the agency has not had a social worker since the social worker retired. She said she did not know the exact date but believed it to be around March 2020. The agency has failed to meet the condition of participation for skilled services, as they were unable to produce evidence of a social worker on staff or a contracted social worker available to provide social services for their clients.