Onoria Health Care Provider Inc. Home Health and Ho

“Policies/Procedures for Medical Documentation CFR(s): 484.102(b)(4) §403.748(b)(5), §416.54(b)(4), §418.113(b)(3), §441.184(b)(5), §460.84(b)(6), §482.15(b)(5), §483.73(b)(5), §483.475(b)(5), §484.102(b)(4), §485.68(b)(3), §485.542(b)(5), §485.625(b)(5), §485.727(b)(3), §485.920(b)(4), §486.360(b)(2), §491.12(b)(3), §494.62(b)(4). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(5) or (3),(4),(6)] A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records. *[For RNHCIs at §403.748(b) and REHs at §485.542(b):] Policies and procedures. (5) A system of care documentation that does the following: (i) Preserves patient information. (ii) Protects confidentiality of patient information. (iii) Secures and maintains the availability of records. *[For OPOs at §486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. This Standard is not met as evidenced by: Based on interview and record review, the agency failed to ensure to updated patient records were readily available to support continuity of care during an emergency, when the agency’s emergency preparedness policy and procedure did not contain the most current patient roster. This failure had the potential for the agency to not be able to adequately assess and address the needs of the patients, and to implement immediate intervention during emergencies, putting 122 patients’ safety and well-being at risk. Findings: A review of the agency’s “Emergency Preparedness Program Binder,” from January 1, 2023, to March 21, 2024, was conducted. The agency’s Emergency Preparedness Program Binder indicated the last patient roster was dated on November 3, 2023. The patient roster contains active patients, patients who have been discharged after November 3, 2023, and does not account for patients admitted to the agency after November 3, 2023. During an interview on March 21, 2024, at 2:00 PM, with the Administrator (Admin), the Admin stated he was the person responsible for the agency’s emergency preparedness plan, including updating patient roster. The Admin was not able to provide an explanation as to why the patient roster had not been updated since November 2023. A concurrent interview and record review was conducted with the Admin on March 21, 2024, at 2:30 PM. The Admin reviewed of the agency’s undated policy and procedure (P&P) titled, “Emergency Preparedness Program [EPP] for [name of home health agency],” which indicated “…Designated clinicians will be assigned to assist the Disaster Coordinator and Alternate in identification of patients affected by the emergency and assigning clinical staff members to check on those patients by utilizing the patient classification system. • The Disaster Coordinator will initiate the procedure to triage patients. Onoria Healthcare Provider, Inc. will access recorded information about active patients’ classification that is determined at the Start of Care comprehensive assessment and updated at subsequent comprehensive assessments, as needed, due to changes in patients’ needs. This classification system categorizes the patients in groups based on the services Onoria Healthcare Provider, Inc. provides to the patient and their need for continuity of these services. It also specifies the availability of someone to assume responsibility for a patient’s emergency response plan as needed by the patient…. • A patient roster (on-call list) for each area serviced by Onoria Healthcare Provider, Inc. will be maintained and updated at least weekly with the following information: Patient’s name • Address •Date of birth and age • Allergies • Current medications • Medical diagnoses • Blood type (if known) • Advance Directives • Next of kin/emergency contacts • Emergency Preparedness Plan (EPP) classification (patient classification) • The Disaster Coordinator or designee will keep an updated copy of the patient roster. Supervisors of outlying areas should also keep a copy of the roster…” The Admin stated he was not aware the patient roster needed to be updated weekly as per the agency’s P&P. The Admin further stated the agency did not follow the policy.”

“Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA’s services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This Standard is not met as evidenced by: Based on interview and record review, the home health agency failed to conduct and document, at a minimum, one performance improvement projects (PIP - a concentrated effort on a particular problem in one area of the agency or agency wide; it involves gathering information systematically to clarify issues or problems, and intervening for improvements) each calendar year which reflected the scope, complexity, and past performance of the agency’s services and operations. This failure had the potential to cause problems in health outcomes, patient safety, and quality of care to go unaddressed and continue in a universe of 122 patients. Findings: A review of the agency’s “Quality Assessment and Performance Improvement (QAPI) [process that aims to improve the quality of care and services provided to patients]” binder for March 1, 2023, to March 18, 2024, was conducted, indicated the following: “… April 12, 2023… During the investigation, the type of infection [illnesses caused by germs] identified to be at highest rate is Urinary Tract Infection [infection usually caused by bacteria, in the bladder]…” “… October 18, 2023… During the investigation, the type of infection identified to be at highest rate are wound (an injury that breaks the skin or other body tissue) or skin…” “… January 21, 2024… During the investigation, the type of infection identified to be at highest rate are wound or skin…” There was no documented evidence to show PIP had been initiated, were in process, or had been completed after the quality indicator identified from the data collection and analysis were reviewed. During an interview with the Director Patient Care Services (DPCS) and Administrator (Admin) on March 20, 2024, at 11:45 AM, the DPCS stated he was responsible for the QAPI Program. The DPCS stated she was not aware PIPs had to be initiated after she analyzed the data and the quality indicator identified. The DPCS further stated it should had been initiated. During a concurrent record review and interview, with the DPCS, on March 20, 2024, at 4:00 PM, the DPCS reviewed the agency’s undated policy and procedure (P&P) titled, “[Name of the agency] QAPI Program”, which indicated, “… B. Address All Services 1. The program will cover all services provided by the agency, including: a. Skilled nursing b. Physical therapy c. Occupational therapy d. Speech therapy e. Medical social work f. Home health aide services 2. The QAPI program will also address ancillary services, such as medical supplies and equipment management. 3. The program will ensure that all services are delivered in accordance with applicable federal, state, and local regulations, as well as agency policies and procedures … IV. Performance Improvement Projects (PIPs) A. Identification and Prioritization 1. The QAPI Coordinator, in collaboration with the leadership team and staff, will identify potential areas for improvement based on: a. Data analysis and trends b. Staff suggestions and observations c. Patient and caregiver feedback d. Best practices and evidence-based guidelines 2. The agency will prioritize PIPs based on their potential impact on patient outcomes, safety, and satisfaction, as well as the feasibility of implementation… a. Plan: Define the problem, set goals, and develop an intervention plan b. Do: Implement the intervention on a small scale….” The DPCS stated the agency did not follow the policy. During a concurrent record review and interview, with the DPCS, on March 20, 2024, at 4:15 PM, the DPCS reviewed the agency’s P&P titled “Performance Improvement. Improving Organization Performance ” revised May 2023, which indicated, “PURPOSE. To establish a performance improvement framework, which integrates activities to improve organization performance, manage change, improve patient safety, improve quality of care, treatment or services and reduce the risks for acquisition and transmission of infections. To improve organizational performance by focusing on high risk, high volume, and problem-prone areas. Procedure… B. Set expectations for performance improvement, set priorities and frequency of data collection and manage processes to improve organization performance. C. Focus on high risk, high volume, and problem-prone areas. Consider incidence, prevalence, and severity of problems in those areas and lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. 1. Planning for performance improvement with integration of information from other relevant activities… g. Other high risk, high volume and problem prone areas when identified by data collection … 4. Implementing improvement on the basis of assessment and comparison data….” The DPCS stated the agency did not follow the policy.”

“Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This Standard is not met as evidenced by: Based on observation, interview, and record review, the facility failed to ensure patient medical supplies were properly maintained to reduce the spread of microorganisms (small organisms that can cause illness, such as bacteria and viruses), when eight foley catheter insertion trays (a tubular device that drains urine from the bladder into a collection bag), four 24 gauge (thickness, size, or capacity of something, especially as a standard measure) intravenous catheters (a thin, flexible tube that is inserted into a vein used to give fluids and medications), one Jackson Pratt drain (surgical suction drain that gently draws fluid from a wound), and eight 22 French (French-unit of measurement, size of a catheter) foley catheters were found expired in the supply room, ready to be used by the nurses. This failure had the potential to result in the spread of microorganisms to 122 immunocompromised (weak immune system) vulnerable patients, placing their health and safety at risk. During a facility tour observation conducted on March 18, 2024, at 1:45 PM, with the Staffing Coordinator (SC), in the supply room, eight foley catheter insertion trays were found to be expired with an expiration date of June 1, 2022. During a further observation on March 18, 2024, at 1:50 PM, with the SC, in the supply room, four 24-gauge intravenous catheters were found with an expiration date of August 2018, one Jackson Pratt drain with an expiration date of August 31, 2018, and eight 22 French foley catheters with the expiration date of April 28, 2022. During a concurrent observation and interview, on March 18, 2024, at 1:55 PM with the SC, in the supply room, the expired supplies were inspected. The SC stated the medical supplies were checked for expiration dates yearly. The SC further stated the expired medical supplies were missed. During an interview, on March 19, 2024, at 9:44 AM, with the Licensed Vocational Nurse (LVN), the LVN stated foley insertion trays or foley catheters were gathered from the home health office. During a concurrent interview and record review, on March 21, 2024, at 2:30 PM, with the Director of Patient Care Services (DPCS), the facility’s policy and procedure (P&P) titled, “Equipment and Supply Management”, undated was reviewed. The P&P indicated, “The purpose of this policy is to establish guidelines for the safe and effective handling and storage of medical supplies in the home health setting, including regular monthly checks for expiration dates and expired supplies...5. Expired supplies must be promptly removed from inventory and disposed of properly…PROCEDURE: … 4. Monthly expiration date checks: a. designate a specific day each month to conduct a comprehensive check of all medical supplies for expiration dates…c. Remove any expired or compromised supplies from inventory and dispose of them according…”. The DPCS stated the policy was not followed.”

“RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient’s return home, or on the physician or allowed practitioner - ordered start of care date. This Element is not met as evidenced by: Based on interview and record review, the agency failed to ensure the patients’ initial assessment was completed by a Registered Nurse (RN) within 48 hours of the physician’s referral date for one of 13 sampled patients (Patient 8). This failure had the potential to cause a delay in the determination of Patient 8’s immediate intervention, treatment, care, and support needs. Findings: A review of Patient 8’s face sheet (a document that gives a summary of patient’s information), indicated a Start of Care (SOC) date of December 15, 2023, with a certification period of February 13, 2024 to April 12, 2024. Patient 8 had diagnoses that included infection (illnesses caused by germs) and inflammatory (swelling and redness) reaction due to internal (inside) right knee prosthesis (artificial body parts designed to restore function or appearance). A review of Patient 8’s referral order, dated December 5, 2023, indicated, “To [name of the agency]… Re: [name of Patient 8]… Date: 12/5/23 [December 5, 2023]…”. A review of Patient 8’s initial admission assessment report, dated December 15, 2024 (ten days after the referral date), indicated, “… Patient: [name of Patient 8]… Date of Contact: 12/15/2023 [December 15, 2023]… Patient admitted into home health today 12/15/2023 [December 15, 2023] by … RN...” A review of Patient 8’s admission physician’s order, dated December 15, 2024 (ten days after the referral date), indicated, “SOC order: 12/15/2023 [December 15, 2023]. Patient: [name of Patient 8]… Episode: 12/15/2023 [December 15, 2023] – 2/12/2023 [February 12, 2023]… Orders: Admit patient to [name of home health agency], with SN [Skill Nurse] visit frequency of daily x 6 weeks, then reassess …” Ten days had passed from the date of the physician’s referral to the admission of Patient 8. During an interview with the Director of Patient Care Services (DPCS), on March 21, 2024, at 10:45 AM, the DPCS stated she was not able to provide documentation supporting Patient 8’s admission to the home health agency on December 15, 2023, which is occurred ten days after the initial referral date of December 5, 2023. The DPCS further stated “We did not admit within 48 hours of the referral, and we should have.” During a concurrent interview and record review on March 21, 2024, at 11:45 AM with the DPCS, the agency’s policy and procedure (P&P) titled, “Initial and Comprehensive Assessment” revised May 2023, was reviewed. The P&P indicated, “Purpose. To provide guidelines for the initial assessments of patients admitted to service and for completing plans of care. POLICY An initial patient assessment will be performed and documented in the patient’s clinical record by a registered nurse, physical therapist, occupational therapist or speech therapist on all patients referred. The initial assessment visit must be performed either within 48 hours of the referral, within 48 hours of the patient’s return home, on the start of care date ordered by the physician (or other licensed practitioner), or at the patient/family request with the approval of the physician (or other licensed practitioner)…” The DPCS stated the facility did not follow the policy.”