Saint Elizabeth Home Care (Cathleen Naughton Associates)

“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.”

“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.”

“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.”

“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.”

“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.”

“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.”

“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.”

“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.”

“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.”

“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.”