Every finding on record at Waverly Assisted Living, LLC

An unannounced Federal recertification survey was completed at this agency on 11/29/2022. The agency was surveyed for compliance with 42 CFR Conditions of Participation for Home Health Agencies, Part 484.102 Emergency Preparedness. An entrance conference was held with the Administrator on 11/14/2022 at 11:15 AM. The purpose of the survey and the survey needs were explained. An opportunity was provided for questions, answers and comments. Definitions and abbreviations: CFR - Code of Federal Regulations EOP - Emergency operations plan HHA - Home health agency WAH - Wellness at Home

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on interview and document review, it was determined the agency failed to review and update the emergency preparedness plan at least every two years. Findings: During an interview with Employee #1 on 11/17/2022 beginning at 10:25 AM, the emergency preparedness program was discussed, and documentation was requested. Employee #1 presented a document titled "Wellness at Home in Albany (HHA) Emergency Operations Plan." The title page indicated "Last Update: 07/2019." The "Program Responsibilities" section of the document stipulated "It is the responsibility of this program to create and maintain these plans and exercise and update them on an annual basis in a continuing effort to increase the resiliency of WAH and the populations we serve." The "Plan Maintenance" section of the document stipulated "The Administrator with support from Director of Quality Assurance/Compliance is responsible for ensuring that the Wellness at Home in Albany HHA EOP is reviewed and updated on a yearly basis and any listed items on the Improvement Plan are incorporated into the annual EOP review." At the conclusion of the emergency preparedness interview on 11/17/2022, Employee #1 indicated parts of the program had been updated, as evidenced by handwritten updates to contact information for "Emergency Staff," but acknowledged that the entire program was "probably not" reviewed/updated since 2019.

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on interview and document review, it was determined the agency failed to review and update a hazard vulnerability risk assessment every two years. Findings: During an interview with Employee #1 on 11/17/2022 beginning at 10:25 AM, the emergency preparedness program was discussed, and documentation was requested. Employee #1 presented a document titled "Emergency Preparedness Guide...Hazard Vulnerability Assessment." The form was not dated, and Employee #1 was unable to determine when it was completed. The form contained a mixture of type-written and handwritten entries. The form was not signed and did not reference the agency. Employee #1 was unable to discern whether the form was an example provided as part of a guide that was purchased or if it was completed entirely by an agency employee.

An unannounced Federal recertification survey was completed at this agency on 11/29/2022. The agency was surveyed for compliance with 42 CFR Conditions of Participation for Home Health Agencies, Part 484. An entrance conference was held with the Administrator on 11/14/2022 at 11:15 AM. The purpose of the survey and the survey needs were explained. An opportunity was provided for questions, answers and comments. The findings from this survey reflect the following Condition-Level deficiencies were identified: 42 CFR CoP § 484.65 Quality assessment/performance improvement 42 CFR CoP § 484.70 Infection prevention and control 42 CFR CoP § 484.105 Organization and administration of services Definitions and abbreviations: ACHC - Accreditation Commission for Health Care, Inc. ADA - American Disabilities Act CFR - Code of Federal Regulations CMS - Centers for Medicare & Medicaid Services CoP - Condition of Participation DOR - Director of Rehab HHA - Home Health Agency IDT - Interdisciplinary team Kantime - the electronic medical record system used by the agency med rec - medication reconciliation no. - number PIP - Performance improvement project Q4 - Quarter 4 QAPI - Quality Assessment Performance Improvement

Contact info Federal/State-funded entities CFR(s): 484.50(c)(10)(i,ii,iii,iv,v) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: (i) Agency on Aging (ii) Center for Independent Living (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. This ELEMENT is not met as evidenced by: Based on interview and document review, it was determined the agency failed to advise patients of the names, addresses, and telephone numbers of the Federally-funded and state-funded entities that serve the area where the patient resides as required. Findings: The "Client Handbook," revised 4/14/2022, included in the admission folder given to patients on admission, was reviewed. The handbook reflected in the section titled "Client Rights and Responsibilities," "1. The Client Bill of Rights statement defines your right to...Z3. The names, addresses, and telephone numbers (see page# [sic] 14 & 15) of the following Federally-funded and state-funded entities that serve the area where the client resides: 1. Agency on Aging; 2. Center for Independent Living; 3. Protection and Advocacy Agency; 4. Aging and Disability Resource Center; 5. Quality Improvement Organizations." Review of pages 14 and 15 revealed the information was not provided as stated. Review of the entire "Client Handbook" and admission folder revealed the required information was not provided. During an interview with Employee #1 on 11/17/2022 beginning at 10:25 AM the finding was presented. Employee #1 acknowledged the finding and stated, "That has been on my list since I came here."

Access to auxiliary aids and language service CFR(s): 484.50(c)(12) Be informed of the right to access auxiliary aids and language services as described in paragraph (f) of this section, and how to access these services. This ELEMENT is not met as evidenced by: Based on interview and document review, it was determined the agency failed to provide clear information regarding access to auxiliary aids and language services and how to access these services. Findings: The "Client Handbook," revised 4/14/2022, included in the admission folder given to patients on admission, was reviewed. Page 9 of the document included the statement "Wellness at Home Health provides free language services to people whose primary language is not English such as qualified interpreters and information written in other languages. If you need these services, contact the Section 504/ADA Coordinator/Section 1557 Civil Rights Coordinator at 971-204-7200." During an interview with Employees #1, #2 and #3 on 11/28/2022 beginning at 2:00 PM, the finding was presented, and the employees were asked if patients were required to contact this number if language services were needed. Employee #1 stated that the information was not correct; the agency "has a contract with Language Link" and the agency will engage interpreter services when needed. Employee #1 acknowledged that the information provided to patients may be confusing and the "Client Handbook needs to be updated."

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 medical record review, it was determined the agency failed to conduct an initial assessment visit to determine the immediate care and support needs of the patient within 48 hours of referral for 2 of 7 active patient records reviewed (Patients #9 and #10). Findings: Patient #9: Review of the electronic medical record revealed the agency received a referral from the medical provider on 10/28/2022. Documentation of the intake by the agency indicated the referral was received on 10/31/2022. Documentation indicated the initial assessment occurred 11/1/2022. During an interview with Employees #1, #2 and #3 on 11/28/2022 beginning at 2:00 PM, the above finding was presented, and the employees were asked for information regarding why the referral was received 10/28/2022 but was not documented as received and was not acted upon until 10/31/2022. Employee #3 stated "10/28 was a Friday and intake doesn't work weekends, so it was not picked up until Monday 10/31." Employees #1 and #3 acknowledged the finding and agreed that the initial assessment visit did not occur within 48 hours of the referral. Patient #10: Review of the electronic medical record revealed the agency received a referral from the medical provider on 10/14/2022. Documentation of the intake by the agency indicated the referral was received on 10/17/2022. On 10/17/2022, the agency requested an order from the medical provider to delay the start of care until 10/21/2022. Documentation indicated the initial assessment occurred 10/21/2022. During an interview with Employees #1, #2 and #3 on 11/28/2022 beginning at 2:00 PM, the above findings were presented. The employees were asked for information regarding why the referral was received 10/14/2022 but was not documented as received until 10/17/2022. Employee #3 noted that 10/14/2022 was a Friday and 10/17/2022 was a Monday, and stated "It was over a weekend again, we probably didn't get it until Monday." The employees were asked for information regarding why a delayed start of care request was sent to the provider. The employees did not find information documented in the medical record to justify the request. Employee #1 stated "I don't know what happened." Employee #3 stated "I bet it was availability [meaning the agency did not have a clinician available to start care]."

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on interview, medical record review and document review, it was determined the agency failed to provide written information to the patient regarding the name and contact information of the HHA clinical manager. Findings: During an interview with Employee #1 on 11/17/2022 beginning at 10:25 AM, Employee #1 stated that Employee #3 was the agency clinical manager. Review of medical records and written information presented to patients revealed the agency failed to include Employee #3's name and contact information. During an interview with Employees #1, #2 and #3 on 11/28/2022 beginning at 2:00 PM, Employees #1 and #3 acknowledged that contact information for Employee #3 was not provided.

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 interviews and document review, it was determined the agency failed to: -Develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program; -Ensure governing body involvement in the development, approval and ongoing monitoring of the QAPI program; -Maintain documentary evidence of its QAPI program and be able to demonstrate its operation. Findings: Refer to findings identified in tags G0642, G0644, G0654, G0656, G0658 and G0660.

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: Based on interview and document review, it was determined the agency failed to measure, analyze and track quality indicators as needed to maintain a QAPI program capable of showing measurable improvement. Findings: During an interview with Employee #1 on 11/17/2022 beginning at 10:25 AM, the QAPI program was discussed. Employee #1 stated that "no meetings" were held for QAPI, "we talk about it after IDT meetings." When asked if QAPI discussions were documented, Employee #1 stated "not really, we do have a form we look at." A request for any QAPI documentation available resulted in three documents being presented. One document, titled "QAPI," undated, revealed two pages that outlined how a QAPI program should be developed. Example statements were included but statements developed by, and specific to, the agency were missing. The following pages revealed "Plan/Do/Study/Act" documentation of 5 performance improvement projects. Four of 5 performance improvement project documents included brief notes, dated with dates lacking the year. During an interview with Employees #1, #2 and #3 on 11/28/22 beginning at 2:00 PM, it was determined the notes were from 2021. The document included only two notations from 2022; "1/12 - Home Health Aid [sic] supervision notes have not been sent out by clinical manager after manager stepped down on 12/31" and "5/2/22 check: [employee name] who led the fall prevention program is taking summer leave. On June 1, 2022 a new clinician will lead the fall prevention program." None of the entries were signed. Another document was presented by Employee #1 as "the last QAPI data we have." The single page heading stated, "Med Rec Monday 12/20/21." Twenty-one patient names were listed with a "yes" or "no" designation next to the name. Analysis revealed 8 of 21 medication reconciliations were performed for 38.1% compliance. Documentation failed to address discussion of the findings. The final document presented by Employee #1 was described as "this is what we look at when we talk after IDT." The undated document heading stated "Wellness at Home QAPI Leadership Team:" under which 8 employee names were listed. The document outlined data sources to discuss and the frequency of data collection. "Benchmarks to analyze this data source" included entries such as "Identified Best Practices," or "organizational data," and "State and national data." Specific benchmarks, data collected, related discussions, progress toward improvement was missing. The document listed "Our Current Projects include: 1. Order progression project 2. Fall Prevention Program 3. Medication Reconciliation." No further information was given. The document listed "Needed Projects include: Home Health Caregiver PIP project; Complaints process with abuse and neglect report PIP project; Infection control process PIP project; Training Process PIP project." None of the information was dated. Review of the agency policy titled, "IMPROVING ORGANIZATIONAL PERFORMANCE Policy No. 5-001.1," dated "ACHC Home Health/Revised April 2021" stipulated "The Governing Body is responsible for ensuring that the performance improvement program is defined, implemented and maintained, and is evaluated annually." The policy further stipulated "1. Senior management will...E. Identify and set specific outcomes for measurable improvement and acceptable limits for findings...I. Allocate resources for performance improvement activities by...3. Creating and maintaining information systems and data management processes to support the collecting, managing and analyzing of data to improve performance, 4. Utilizing appropriate statistical techniques to analyze and display data." The policy further stipulated, "Trends identified through performance improvement measurement and analysis will be reported to the Governing Body on a quarterly basis." Review of governing body meeting minutes failed to demonstrate compliance with the policy. See tag G0942 for more information.

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on interview and document review, it was determined the agency failed to utilize quality indicator data to monitor the effectiveness and safety of services, quality of care, and identify opportunities for improvement by using data collection methods approved by the governing body. Findings: Refer to findings identified in tag G0642.

Track adverse patient events CFR(s): 484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. This STANDARD is not met as evidenced by: Based on interview and document review, it was determined the agency failed to analyze adverse patient event causes and implement preventative actions. Findings: During an interview with Employee #1 on 11/17/2022 beginning at 10:25 AM, the QAPI program was discussed. Employee #1 was asked specifically for documented analysis of adverse patient events such as falls and infections. Employee #1 stated "we do talk about falls after IDT; we don't talk about infections." Employee #1 presented a document with the heading "Wellness at Home QAPI Leadership Team:" as "this is what we look at when we talk after IDT." The form did list "Data Sources" of: "Abuse, Neglect, Maltreatment reports; Complaints; Falls; Medication Errors; Rehospitalization Rates; Satisfaction Surveys." Documentation of the discussions, cause analysis, implementation of preventative actions was not presented.

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: Based on interview and document review, it was determined the agency failed to maintain documentation of performance improvement measure implementation, success and that improvements are sustained. Findings: Refer to tag G0642 for findings identified regarding the extent of QAPI documentation provided.

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 document review, it was determined the agency failed to maintain documentation of the measurable progress achieved on performance improvements projects. Findings: Refer to tag G0642 for findings identified describing QAPI documentation provided. Documentation indicated that current performance improvement projects were started in 2021. Documentation for 2022 failed to address measurable progress achieved.

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: Based on interviews and document review, it was determined the agency governing body failed to ensure an ongoing program for quality improvement and patient safety was defined, implemented and maintained; that the QAPI program efforts addressed priorities for improved quality of care and patient safety, and that all improvement actions were evaluated for effectiveness; and that clear expectations for patient safety were established, implemented and maintained. Findings: Refer to tag G0942 for findings identified regarding governing body meeting minute documentation provided. Review of the governing body meeting minutes with the uncertain date of either 12/23/2019 or 1/17/2020, revealed that the QAPI program was on the agenda. Additional governing body meeting minutes provided did not address QAPI. Refer to tags G0642, G0644, G0654, G0656 and G0658 for findings identified in the areas of QAPI program deficiency.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on interviews and review of documentation, it was determined the agency failed to: -Maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases; -Include infection control as an integral part of its QAPI program; -Develop a method for identifying infectious and communicable disease problems; -Develop a plan for the appropriate actions that are expected to result in improvement and disease prevention. Findings: Refer to findings identified in tag G0684.

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: Based on interview and document review, it was determined the agency failed to 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 failed to include a method for identifying infectious and communicable disease problems, and a plan for the appropriate actions that are expected to result in improvement and disease prevention. Findings: During an interview with Employee #1 on 11/17/2022, beginning at 10:25 AM, the infection control program was discussed. Employee #1 stated that infections were "tracked in Kantime because it alerts us when a patient is on antibiotics" and when that alert is given "someone, usually me, enters a statement regarding why the antibiotic is being used." Employee #1 was asked if anything further was done with the information and they replied "no, not really." Policies regarding an infection control program were requested. One policy presented was titled "Infection Control Precautions Policy No. 4-058.1" with a purpose statement of "To provide guidelines for the instruction of patients and family/caregivers in infection control precautions." Another policy presented was titled "Mangement of Exposures in Personnel Policy No. 6-001.1" with a purpose statement of "To properly identify, manage, and report personnel exposures to infections." Both policies failed to address methods for compiling infection data, identifying infectious and communicable disease problems and developing plans for the appropriate actions that are expected to result in improvement and disease prevention. Review of QAPI documentation titled "Wellness at Home QAPI Leadership Team:" undated but presented by Employee #1 as "what we talk about after IDT meetings," revealed infections were not included among the "Data Sources" discussed. Under a heading "Needed Projects Include:" was the statement "Infection control process PIP project (show ongoing education and any problems)." Documentation of infection surveillance, analysis, identification of problems or patterns, plans to result in improvement and disease prevention was requested. No documentation was provided.

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: Based on interviews and review of documentation, it was determined that the Governing Body failed to: -Assume responsibility for the agency's overall management, including its QAPI program; -Ensure a clinical manager was available during all operating hours; -Ensure a qualified administrator alternate was pre-designated in writing; -Ensure the duties of the clinical manager were performed by qualified personnel. Findings: Refer to findings identified in tags G0942, G0950, G0954, G0958, and G0960.

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on interview and review of agency documentation, it was determined the governing body failed to assume responsibility for the agency's overall management and operation, review of operational plans, and its quality assessment and performance improvement program. Findings: Review of the agency policy titled "GOVERNING BODY Policy No. 1-002.1," dated "ACHC Home Health/Revised April 2021" stipulated "PROCEDURE...3. The Governing Body will appoint a Governing Body to work with Senior Leadership and the Performance Improvement Committee to review and develop policies and procedures consistent with the organization's mission; annually review and revise policies and procedures; prepare an annual evaluation of Wellness at Home in relation to its mission; and assist in identifying goals and measuring accomplishments of the organization's operations." A request for documentation of governing body meeting minutes revealed a document titled "WELLNESS AT HOME IN ALBANY GOVERNING BODY MEETING MINUTES," dated 12/23/2019. The cover page had the date lined out with 1/17/20 handwritten above it; and handwritten notes "employee polices - send to [name]" and "other policies fix and then send for approval." Other areas that documented "Meeting Date: 12/23/2019" were not amended. Documentation regarding the date of the meeting was not clear. The "4. AGENDA" portion of the document stated "QUAPI [sic] schedule/calendar. Review of calendar for the remainder of this year and agenda for today's QUAPI [sic] meeting: Fall Prevention Program - Director of Rehab education to staff about beginnings of Fall Prevention Program. DOR to work on program, ongoing. Q4 Quarterly Report review and approval. Recommendations for changes." The document contained blanks that were not filled in: "2 Meeting called to order with quorum present at _____; [name] motions for approval. _____ 2nds motion; 8 With no further business, meeting adjourned at _____." The document stipulated "7 NEXT MEETING Date: 03/23/2020." Documentation of a meeting held 03/23/2020 was absent. The next documentation of governing body meeting minutes presented for review was titled "GOVERNING BOARD," dated "MAY 2021." Meeting attendees were not documented. The document consisted of areas titled "Marketing Plan...Compliance Plan...Staffing & Expenses." The compliance plan section documented "Compliance needs are two-factorial; the daily needs for current and correct charting; and the long-term needs for operational auditing." Documentation did not address QAPI review. The only documentation regarding policy review was "[name of administrator] and [name of director of rehab] to identify weekly time to meet to divide and review current policies and procedures, and adjust as necessary for upcoming audit." During an interview with Employee #1 on 11/17/2022 beginning at 10:25 AM, Employee #1 was asked if any governing body meetings had been held since they assumed their current position in 7/2021. Employee #1 stated they had a conversation with a governing body member in 8/2021 but they had not been part of any formal governing body meetings. A request was made for documentation to demonstrate governing body annual review/revision of policies and procedures, and approval and review of the QAPI program. No further documentation was provided.

Ensure clinical manager is available CFR(s): 484.105(b)(1)(iii) (iii) Ensure that a clinical manager as described in paragraph (c) of this section is available during all operating hours; This ELEMENT is not met as evidenced by: Based on interview and document review, it was determined the agency failed to ensure that a clinical manager is available during all operating hours. Findings: Review of agency documentation provided during the entrance conference, including but not limited to the admission folder and patient medical records, failed to clearly identify who the clinical manager was, and that the clinical manager was available during all operating hours. During an interview with Employee #1 on 11/17/2022 beginning at 10:25 AM, the role of the clinical manager was discussed. Employee #1 stated that Employee #3 was designated as the clinical manager but worked only part time as that individual held two jobs, outside the agency, in addition to that of clinical manager. During an interview with Employees #1, #2 and #3 on 11/28/2022 beginning at 2:00 PM, the finding that the clinical manager was not available during all operating hours was presented. Employee #3 nodded their head in agreement with the finding.

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: Based on interview, it was determined the agency failed to identify a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, to assume the same responsibilities and obligations as the administrator when the administrator is not available. Findings: During an interview with Employee #1 on 11/17/2022 beginning at 10:25 AM, written documentation of the pre-designated alternate for the administrator was requested. Employee #1 was unable to find documentation and could not recall any designation being established since taking their position in 7/2021.

Clinical manager CFR(s): 484.105(c) Standard: Clinical manager. One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following-- This STANDARD is not met as evidenced by: Based on interview, it was determined the agency failed to ensure that oversight of all patient care services and personnel was provided by the clinical manager and not delegated to another person on an on-going basis. Findings: During an interview with Employee #1 on 11/17/2022 beginning at 10:25 AM, the role of the clinical manager was discussed. Employee #1 stated that Employee #3 was designated as the clinical manager but worked only part time as that individual held two jobs, outside the agency, in addition to that of clinical manager. Employee #1 stated the clinical manager primarily "orders supplies and follows up on some orders." Employee #1 indicated that the duties of the clinical manager were informally shared with other staff members based on availability. During an interview with Employees #1, #2 and #3 on 11/28/2022 beginning at 2:00 PM, the inability of the clinical manager to perform the required duties while working only part time was discussed. Employee #3 nodded their head in agreement that duties were delegated. Refer to findings identified in tag G0960 for additional information.

Make patient and personnel assignments, CFR(s): 484.105(c)(1) Making patient and personnel assignments, This ELEMENT is not met as evidenced by: Based on interview and review of employee qualifications, it was determined the agency failed to ensure that the clinical manager responsibilities of making patient and personnel assignments were completed by an employee who meets the qualifications of clinical manager. Findings: During an interview with Employee #1 on 11/17/2022 beginning at 10:25 AM, the role of clinical manager was discussed. Employee #1 indicated the responsibility of scheduling initial visits and personnel assignments was performed by Employee #4. Review of personnel information revealed Employee #4 was a licensed practical nurse and did not meet the qualifications for clinical manager found at §484.115(c).