Pediatric Nursing Specialists of Indiana

“Skilled services furnished CFR(s): 484.105(f) Standard: Services furnished. Skilled nursing services and at least one other therapeutic service (physical therapy, speech-language pathology, or occupational therapy; medical social services; or home health aide services) are made available on a visiting basis, in a place of residence used as a patient’s home. An HHA must provide at least one of the services described in this subsection directly, but may provide the second service and additional services under arrangement with another agency or organization. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure it provided Skilled Nursing and/or one other therapeutic service in 1 of 1 agency. Findings include: 1. A review of a policy dated Oct 2022 titled ‘SERVICES PROVIDED CI-100’ revealed “Agency will provide intermittent, part-time or extended hours of skilled nursing and home health aide services ... Agency will also provide Physical Therapy, Speech Therapy, Occupational Therapy, and Medical Social Services ...”. 2. A review of the Home Health Agency Survey Report Form 1572 revealed the only service provided was Skilled Nursing services. 3. On 08/07/2024 at 9:22 AM, during the entrance conference, the Administrator indicated the only service the agency provided was Skilled Nursing services. 4. On 08/08/2024 at 2:35 PM, the Administrator indicated the agency had 2 Home Health Aides it hired. One was to obtain their CPR prior to being assigned a case and the other was going through training. The Administrator indicated they had not been able to hire therapy personnel so there were no therapy cases to date. The Administrator further indicated they can’t accept new patients if they don’t have the staff.”

“EP Training and Testing CFR(s): 484.102(d) §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: Based on record review and interview the agency’s Emergency Program failed to evidence testing and training as part of their plan, in 1 of 1 Emergency Preparedness program reviewed. Findings include: 1. A review of an agency document titled ‘EMERGENCY PREPAREDNESS POLICY’ dated 02/08/2019, failed to evidence testing and training as part of the agency’s program. 2. A review of the agency’s Emergency Preparedness binder on 02/09/2024 failed to evidence a plan or procedure for testing and training the agency’s Emergency Preparedness Plan. 3. On 02/09/2024 at 1:05 PM during an interview, Corporate Personnel 7 serving the role of the Administrator for the agency indicated they had developed an emergency preparedness training and testing program, they reviewed the program to make sure everyone was aware of the plan, but there was no documentation.”

“EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: Based on record review and interview the agency failed to participate in a full-scale exercise that is community-based or conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise in 1 of 1 Emergency Preparedness program reviewed. Findings include: 1. A review of an agency document dated 01/22/2020, titled ‘EMERGENCY PREPAREDNESS POLICY’ failed to evidence a testing and training plan or procedure as part of the agency’s program. 2. A review of the agency’s Emergency Preparedness binder on 02-05-2024 failed to evidence of a full-scale, community-based exercise or the agency’s own Emergency Preparedness exercise. 3. On 02/09/2024 at 1:09 PM, Corporate Personnel 7 serving the role of the Administrator for the agency indicated they were aware this was a requirement but hadn’t had time to conduct the exercise.”

“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 record review and interview, the agency failed to ensure the frequency and detail of the data collection in the development of the QAPI program was approved by the agency’s governing body in 1 of 1 agency. Findings include: 1. A review of a policy titled “QAPI COMMITTEE” revised in January 2018, indicated under “SPECIAL INSTRUCTIONS … 3. Frequency and detail of data collection developed by QAPI committee and approved by governing body … “ 2. A review of the agency’s QAPI on 2/12/24 revealed an undated document identified as “tracking items”, which was divided into two columns, the Administrative column listed: Governing Body meetings, missed visits, in-person assessments, job descriptions all updated, office coverage, Indiana Department of Health update, and in-person supervisory visits; under the Quality Column: Comprehensive assessments, and safety precautions updated and In-person supervisory visits. 3. A review of Governing Body Minutes dated 01/29/2024 revealed, ” … QAPI is being reviewed weekly and there are no concerns ... “ No other documents were provided to evidence other meetings which might identify governing body approval of the frequency and detail of data collection. 4. On 02/09/2024 at 9:10 AM during an interview, Corporate Personnel 7 serving the role of the Administrator for the agency indicated the undated document identified as “tracking items” were Performance Improvement Projects that were identified from the past survey and were discussed at the board meeting, but was unsure if they were approved by the governing body. 410 IAC 17-12-2(a)”

“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 record review and interview, the agency failed to ensure Performance Improvements Projects (PIPS) were documented, why they were conducting these projects, and measurable progress with each project in 1 of 1 agency. Findings include: 1. An agency policy number B-260, titled “QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT,” dated Jan 2005 with the last revision date of Jan 2018 revealed, “ … OBJECTIVES OF THE PROGRAM … to identify deviations from agency and professional standards and pursue improvement opportunities by assessment, planning and evaluation. To identify, address, track and resolve problems in client care services … To meet state and federal regulatory requirements. To support the organization’s process improvement through data collection and outcome measurement … To reduce factors that contribute to unanticipated outcomes … SPECIAL INSTRUCTIONS 1. … Additional actives for performance improvement will be prioritized by the agency’s governing body … 2. Data will be collected … 4. … to measure process and outcome. 5. Data will be assessed to: a. Identify current level of performance b. Evaluate the stability of the process c. Identify areas to be improved d. Identify strategies to stabilize or improve processes e. Evaluate whether outcomes were achieved … “ 2. A review of the agency’s QAPI on 2/12/24 revealed an undated document identified as “tracking items”, which was divided into two columns, the Administrative column listed: Governing Body meetings, missed visits, in-person assessments, job descriptions all updated, office coverage, Indiana Department of Health update, and in-person supervisory visits; under the Quality Column: Comprehensive assessments, and safety precautions updated and In-person supervisory visits. No other documentation was provided as to why these items were identified and measurable progress with each. 3. On 02/09/2024 at 9:10 AM during an interview, Corporate Personnel 7 serving the role of the Administrator for the agency indicated the undated document identified as “tracking items” were Performance Improvement Projects (PIPs) that were identified from the past survey, that they have trending forms, and might have action plan forms to complete, had Governing Body meeting for approval of the PIPs and the administrator would monitor.”

“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 record review and interview, the agency failed to have a Governing Body assume full legal authority and responsibility for the agency’s overall management and operation, including its quality assessment and performance improvement program. Findings include: 1. A review of a policy titled “Governing Body” last reviewed in January 2018, indicated the duties and responsibilities of the Governing Body were not limited to Appointing a qualified Administrator under state and federal regulations, and agency mission; ensuring an ongoing Quality Assessment and Performance Improvement (QAPI) program for quality improvement and patient safety is defined, implemented, and maintained; reviewing policy and procedures; adopt and periodically review and approve the administrative and personnel policies and procedures. 2. A review of the agency’s policy titled “Quality Assessment Performance Improvement” revised in January 2018, stated “Special Instructions: 1. The governing body appoints a committee that must include clinical administrator, representative of all disciplines/ services provided ... 3. Frequency and detail of data collection developed by QAPI committee and approved by governing body ... 13. The QAPI Committee meeting minutes will be maintained in writing and signed by the Administrator ... “ 3. A review of the Governing Body Minutes dated 1/29/2024 indicated the Alternate Administrator/ Alternate Clinical Manager (Corporate Trainer), LPN 3, and Administrator/ Clinical Manager (Corporate Clinical Administrator) were on the Governing Body, as well as Corporate Representatives 1, 2, 14, 15, 16, 17, and 18. The state agency failed to be notified of board member changes. 4. A review of the Governing Body meeting minutes dated 03/10/2023, 11/20/2023, 11/30/23, 12/04/23, and 12/11/23, failed to evidence that the Governing Body ensured the Quality Assessment and Performance Improvement (QAPI) addressed the program and the agency’s complexity of its organization and services it provides, including services provided under contract or arrangement, indicators related to improved outcomes, emergency care services, hospital admissions and readmissions, and any action that addresses the home health agency’s performance. A review of the meeting minutes dated 1/29/24 indicated the “QAPI is being reviewed weekly and there are no concerns.” During an interview on 02/05/24 at 1:10 PM, when asked if the frequency and detail of data collection were approved by the agency’s Governing Body, LPN 3 indicated she was unsure if the Governing Body approved it. When asked how the Governing Body was involved, the Clinical Supervisor indicated there were weekly Monday meetings where the “checklist” was reported and there was collaboration. No documentation of these weekly meetings was provided by the date of exit. During an interview with the Administrator/ Clinical Manager and LPN 3 on 2/8/24 at 11:40 AM, when asked to explain the QAPI program, how it operated from auditing Performance Improvement Plans (PIPs), who is responsible for the plan, and who is on the committee, they indicated the administrators or designee completes chart and human resource audits. If a trend was found in a particular office, it gets documented, creates a correction plan, and submits this to the Governing Body. When asked how often they have QAPI, they indicated there is a grid, and is done monthly, and then quarterly it would be discussed with all of the Administrators and Governing Body together. If a problem comes up in an agency, it would be brought up on a Monday meeting, regularly quarterly, then as needed. They indicated the committee consists of all Administrators, including the Ohio Administrators. No other documents were provided to evidence meetings were held monthly by the date of exit. During an interview on 2/12/24 at 9:38 AM, when asked to verify who was the QAPI and Governing Body Members, the Clinical Manager indicated LPN 3 was the only person who resided in Indiana, and the remaining “members” were from Ohio. A review of the “Quality Program Administrator” job description, updated on 10/16/2023, the qualifications included but were not limited to graduating from an accredited nursing program with a current license as a Registered Nurse in the state(s) of practice. This document was signed by the Alternate Administrator on 10/16/23. A review of LPN 3’s personnel file failed to evidence any documentation she held a Registered Nurse license. The Organization Chart indicates LPN 3 holds other positions within the agency, such as Quality Director/ Quality Nurse; Intake Director, Intake Nurse and Intake Specialist; and Recruiting Director / Recruiter. 410 IAC: 17-12-1(b) 410 IAC 17-12-2(a)”

“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 record review and interview, the Clinical Manager and the Alternate Clinical Manager failed to ensure one was available upon surveyors’ arrival, failed to ensure they were able to travel within a reasonable distance to the office/and or field, failed to ensure they had a schedule of when they would be at this location on a frequent and consistent basis responsible for the referrals, patient and personnel assignments, coordination of care, patient needs continually assessed, and the plan of care for this agency. Findings Include: Upon arrival at this home health agency on 1/31/24 at 9:30 AM, the door was found to be locked with a note to knock on the door. LPN (Licensed Practical Nurse) 3 was observed walking downstairs to allow surveyors in. No other person was observed in the office with LPN 3. LPN 3 indicated she had called the Administrator/ Alternate Clinical Manager (Corporate Trainer) and the Clinical Manager (Corporate Clinical Administrator), but both of whom reside in Ohio, were not available for the entrance conference. The entrance conference was held with LPN 3 (presumed Alternate Administrator). The Clinical Manager arrived at the Indy location and met with the surveyors at approximately around12 noon. A review of the State Agency notes in the National Database revealed the Alternate Clinical Manager and Clinical Manager assumed their roles effective 10/12/23. On 01/31/24 at 12:45 PM, the Clinical Manager indicated she comes to the office when needed, sometimes monthly to every other month, and works remotely in Ohio. The Clinical Manager indicated that she would get in her car and drive to Indiana if there were an emergency. When asked who manages faxes, physician orders, and referrals, the Clinical Manager indicated LPN 3 (presumed Alternate Administrator) manages them and uploads everything into the patient record. A review of the Geographical Map that was completed, indicated this office’s service area was the entire state. A review of the Administrator’s personnel file revealed the Administrator resides approximately 2 hours away from this office. This provider’s service area requires additional travel time as it goes as far northwest as Lake County (Indiana/ Illinois/ Michigan state line) which is an approximate 4-hour drive, as far northeast as Steuban County (Ohio/ Indiana/ Michigan state line) which is approximately 3.25-hours away, and as far as southwest as Posey County (Illinois/ Indiana/ Kentucky state line) which is approximately 4.25 hours away per Google Maps. Should there be an emergency at this location, the Administrator would not be able to arrive within a reasonable amount of time. On 2/1/24 at 4:00 PM, LPN 3 and the Clinical Manager indicated the Alternate Clinical Manager was only at the office when needed and had not been back since 11/15/23. On 2/02/24 at 4:00 PM, the Alternate Clinical Manager indicated she had not been back to the office since she was here for the other surveys a few months ago and indicated she could return when called to do so. A review of the Alternate Clinical Manager’s personnel file revealed the Administrator resides approximately 4 hours away from this office. This provider’s service area requires additional travel time as it goes as far northwest as Lake County (Indiana/ Illinois/ Michigan state line) which is an approximate 4.5-hour drive, as far northeast as Steuban County (Ohio/ Indiana/ Michigan state line) which is approximately 2.5-hours away, as far as southeast as Switzerland County (Ohio/ Indiana/ Kentucky state line) which is approximately 4.25- hours away, and as far as southwest as Posey County (Illinois/ Indiana/ Kentucky state line) which is approximately 6-hours away per Google Maps. Should there be an emergency at this location, the Administrator would not be able to arrive within a reasonable amount of time. On 2/8/24 at 11:40 AM, the Clinical Manager, the Alternate Clinical Manager, and LPN 3 were interviewed. It was reported LPN 3 was responsible for making the patient and personnel assignments, coordinated care, and referrals. When asked who ensures a patient’s needs are continually assessed, the Clinical Manager and the Alternate Clinical Manager reported LPN 3 and the RN Case Manager were responsible. The Clinical Manager and the Alternate Clinical Manager indicated the RN Case Manager creates the plan of care and LPN 3 sends it to the physician for signature. When asked how they oversee these tasks, both reported they communicate with the case managers, the “quality department”, which is LPN 3, would review it and bring it to their attention, or she takes it directly to the case manager. Both indicated LPN 3 uploads the information to the patient record. A review of the job description for the Quality Administrator which LPN 3 holds indicated the employee must hold a Registered Nurse license. A review of the organizational chart revealed that Corporate Representative 6 also held the following positions: Quality Director and Quality Nurse; Intake Director, Intake Nurse, and Intake Specialist; and Recruiting Director and Recruiter for this agency. 410 IAC 17-12-1(d)”

“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 record review and interview the agency failed to establish a system to measure and track performance to ensure improvements were sustained. Findings include: 1. A review of a policy titled “QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT” revised in January 2018, indicated, “ … 4. Data will be systematically collected to measure process and outcome. 5. Data will be assessed to: a. Identify current level of performance b. Evaluate the stability of the processes c. Identify areas to be improved D. Identify strategies to stabilize or improve processes e. Evaluate whether outcomes were achieved f. Compare results with self, other standards, and best practices, using statistical techniques … “ 2. A review of the agency’s Quality Assessment Performance Improvement (QAPI) failed to evidence a system to measure and track performance to ensure improvements were sustained and failed to evidence a performance improvement grid. 3. On 02/09/2024 at 9:10 AM Corporate Personnel 7 serving the role of the Administrator for the agency indicated they developed a Performance Improvement grid and will have discussions of analysis at quarterly QAPI meetings, but hadn’t initiated this yet. 410 IAC 17-12-2(a)”

“Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This Element is not met as evidenced by: Based on observation, record review, and interview, the Administrator failed to ensure they were available, able to respond to emergencies within a reasonable amount of time, failed to ensure they had a schedule of when they would be at this location on a frequent and consistent basis, and responsible for the day-to-day operations of the home health agency. Findings include: Upon entering the agency on 1/31/23 at 9:15 AM, the door was locked and a note on the window indicated to knock. Upon entering, it was noted only LPN 3 was working in the office. During the entrance conference on 1/31/24 starting at 9:30 AM, LPN 3 indicated a message that the Administrator/ Clinical Manager and the Alternate Administrator/ Alternate Clinical Supervisor were located in Ohio. LPN 3 indicated she was unsure if she was an employee of this agency but was just a helper to them. During the entrance conference on 1/31/24 starting at 9:30 AM, LPN 3 indicated a message was left with the Alternate Administrator/ Alternate Clinical Supervisor (Corporate Trainer), and the Administrator/ Clinical Manager (Corporate Clinical Administrator) was on a visit and would be in around noon. LPN 3 indicated that both the Alternate Clinical Manager/ Alternate Administrator and Administrator/ Clinical Supervisor were in Ohio. The Administrator/ Clinical Manager arrived at the Indy location and met with the surveyors at approximately around12 noon. A review of the State Agency notes in the National Database revealed the Alternate Administrator/ Alternate Clinical Manager and the Administrator/ Clinical Manager assumed their role effective 10/12/23. On 01/31/24 at 12:45 PM, the Clinical Manager indicated she comes to the office when needed, sometimes monthly to every other month, and works remotely in Ohio. The Clinical Manager indicated that she would get in her car and drive to Indiana if there were an emergency. A review of the Geographical Map that was completed, indicated this office service area is the entire state. A review of the Administrator’s personnel file revealed the Administrator resides approximately 2 hours away from this office. This provider’s service area requires additional travel time as it goes as far northwest as Lake County (Indiana/ Illinois/ Michigan state line) which is an approximate 4-hour drive, as far northeast as Steuban County (Ohio/ Indiana/ Michigan state line) which is approximately 3.25-hours away, and as far as southwest as Posey County (Illinois/ Indiana/ Kentucky state line) which is approximately 4.25 hours away per Google Maps. Should there be an emergency at this location, the Administrator would not be able to arrive within a reasonable amount of time. On 2/1/24 at 4:00 PM, LPN 3 and the Administrator/ Clinical Manager indicated the Alternate Administrator/ Alternate Clinical Manager was only at the office when needed and had not been back since 11/15/23. On 2/02/24 at 4:00 PM, the Administrator indicated she had not been back to the office since she was here for the other surveys a few months ago and indicated she could return when called to do so. On 01/31/24 at 12:45 PM, the Clinical Manager indicated she comes to the office when needed, sometimes monthly to every other month, and works remotely in Ohio. The Clinical Manager indicated that she would get in her car and drive to Indiana if there were an emergency. 410 IAC 17-12-(b)(3) 410 IAC 17-12-1(c)(1)”

“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 record review and interview, the agency failed to ensure the presumed Alternate Administrator had a schedule of when they would be at this location on a frequent and consistent basis and failed to ensure a qualified Alternate Administrator was appointed to assume the same responsibilities and obligations as the Administrator during their absence from this agency. Findings include: Upon entering the agency on 1/31/23 at 9:15 AM, the door was locked and a note on the window indicated to knock. Upon entering, it was noted only LPN 3 was working in the office. During the entrance conference on 1/31/24 starting at 9:30 AM, LPN 3 indicated a message was the Administrator/ Clinical Manager and the Alternate Administrator/ Alternate Clinical Supervisor were located in Ohio. LPN 3 indicated she was not sure if she was an employee of this agency but was just a helper to them. A review of the State Agency notes in the National Database revealed that the Alternate Administrator/ Alternate Clinical Manager assumed their role on October 12, 2023. A review of the personnel file evidenced a job description titled Alternate program Administrator dated 10/16/23. A review of the Governing Body minutes dated March 10, 2023, November 20, 2023, November 30, 2023, December 4, 2024, December 11, 2023, and January 8, 2024, failed to evidence that the Alternate Administrator/ Alternate Clinical Manager has been appointed by an agency appointed Governing body. On 01/31/24 at 12:45 PM, the Clinical Manager indicated she comes to the office when needed, sometimes monthly to every other month, and works remotely in Ohio. On 2/1/24 at 4:00 PM, LPN 3 and the Clinical Manager indicated the Alternate Administrator was only at the office when needed and had not been back since 11/15/23. On 2/02/24 at 4:00 PM, the Alternate Administrator indicated she had not been back to the office since she was here for the other surveys a few months ago and indicated she could return when called to do so. A review of the Alternate Clinical Manager’s personnel file revealed the Administrator resides approximately 4 hours away from this office. This provider’s service area requires additional travel time as it goes as far northwest as Lake County (Indiana/ Illinois/ Michigan state line) which is an approximate 4.5-hour drive, as far northeast as Steuban County (Ohio/ Indiana/ Michigan state line) which is approximately 2.5-hours away, as far as southeast as Switzerland County (Ohio/ Indiana/ Kentucky state line) which is approximately 4.25- hours away, and as far as southwest as Posey County (Illinois/ Indiana/ Kentucky state line) which is approximately 6-hours away per Google Maps. Should there be an emergency at this location, the Administrator would not be able to arrive within a reasonable amount of time. During an interview on 2/8/24 at 11:40 AM, when asked how one gets appointed to their positions, the Administrator/ Clinical Manager indicated they have discussions during the Governing Body meetings. When asked if there were Governing Body meeting minutes around October 2023 that would include the appointment of the Alternate Administrator/ Alternate Clinical Manager, the Alternate Administrator/ Alternate Clinical Manager indicated she is the secretary of the Governing Body, she knows it was discussed, and should have been there. No other documents were provided by the exit date of 2/12/24, that would indicate that an Alternate Administrator/ Alternate Clinical Manager was appointed. 410 IAC 17-12-1(d)(1)(2)(3)(4)”

“Primary HHA is responsible for patient care CFR(s): 484.105(e)(3) The primary HHA is responsible for patient care, and must conduct and provide, either directly or under arrangements, all services rendered to patients. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure 2 of 2 service contracts under arrangement were able to provide therapy services that cover the entire state of Indiana. Findings include: 2. A review of an agency document titled ‘ANCILLARY SERVICES AGREEMENT’ indicated a contract was created between the agency and Entity G, a therapy company, to provide physical and occupational therapy services to home health patients. Page 2 stated, “This agreement is entered into on the 11th day of January, 2024, by and between Home Care Network/Pediatric Nursing Specialists (herein referred as “Agency”) whose principal place of business is located [the Corporate office in Ohio’s address was given] (Corporate Office) ...” The contract was signed by Corporate Representative 2 on 01-12-2024. The contract failed to specify which of the three Indiana agencies the agreement had been made with and failed to evidence the services would be pediatric-specific. A review of an agency document titled ’[Entity E, a Therapy company] Contract/Partnership Agreement’ indicated a contract was created between the corporation, Home Care Network, Inc., and Entity E, to provide physical, occupational, and speech therapy services, as well as social work services “for Indiana and Ohio”. The therapy company listed an Ohio address. The corporation, Home Care Network, Inc., also listed an Ohio address. The contract was signed by Corporate Representative 2 on 01-12-2024. The contract failed to specify which of the three Indiana agencies the agreement had been made with and failed to evidence the services would be pediatric-specific. 3. On 01-01-2024 at 9:30 AM during the entrance conference, Corporate Representative 16 indicated the agency had recently secured contracts with two therapy companies but was not yet providing therapy services to patients. On 01-31-2024 at 12:35 PM, Corporate Representative 16 indicated had conferred with Corporate Representative 2, and newly obtained therapy contracts were not individualized to each of the three Indiana agencies, but with Indiana as a whole. On 01-31-2024 at 12:51 PM, Corporate Representative 6 indicated that the two newly contracted Therapy companies, Entities E and G, were chosen to ensure coverage of the entire state. On 01-31-2024 at 2:51 PM, during a telephone call, Person F With Entity E, a Physical Therapy company, indicated was based in Ohio, stated “We don’t service Indiana” and further indicated they had no therapists who were dually licensed in both Ohio and Indiana to provide therapy services. On 01-31-2024 at 3:06 PM, during a telephone call, Person H with Entity G, a Physical Therapy company, indicated the company did not service the entire state of Indiana. Indicated further, for example, the company would be unable to staff anyone in Evansville, IN if a patient needed to be serviced the following day. On 01-31-2024 at 4:08 PM, during a telephone call, Corporate Representative 1 indicated when vetting out therapy agencies to contract with, they attempted to ensure such agencies could service pediatric patients. When queried as to who had vetted Entities E and G, Corporate Representative 1 indicated Corporate Representatives 2, 6, and 16 had done so. When informed Entity E indicated they did not service Indiana, and Entity G indicated they could not service the whole of Indiana, Corporate Representative 1 indicated having had this same kind of problem “wherever we go”, indicating further such companies were also short-staffed. 410 IAC 17-12-2(e) 1. During the entrance conference on 1/31/24 from 9:30 AM to 10:27 AM, when asked if other Registered Nurses (RN) were working in the field besides management, Corporate Representative 6 indicated there were none, other than Corporate Representative 10, a Case Manager, and the field staff was mostly Licensed Practical Nurses (LPN). When asked if she held an undergraduate degree, Corporate Representative 6 indicated she did not due to not finishing school. A review of the employee list indicated that 2 Registered Nurses were working in the office and 7 Registered Nurses and 2 LPNs were working in the field. On 1/31/24 at 12:31 PM, the employee list was reviewed with Corporate Representative 6 and she confirmed there were other Registered Nurses in the field and she misunderstood the question. Upon review of the employee list, Corporate Representative 6 is listed as a Registered Nurse and not that of an LPN. Personnel files were requested on 1/31/24 at 11:30 AM. Corporate Representative 6 failed to have a personnel file for this agency. A review of the personnel file for Corporate Representative 7 contained an I-9 tax form dated 2021 which indicated the employer business is in Centerville, Ohio. No other tax forms were noted in the file. A review of the personnel file for Corporate Representative 8 contained an I-9 tax form dated 2020 which indicated the employer’s business is in Perrysburg, Ohio. No other tax forms were noted in the file. A review of the personnel file for Corporate Representative 10, an RN Case Manager, contained an I-9 tax form that indicated the employer as Home Care Network/ Pediatric Nursing located in Jackson Ohio. The authorized representative was signed by a Corporate Human Resource. The W-4 Employee’s Withholding Certificate indicated the Employer’s name and address as Home Care Network in Dayton Ohio. On 01/31/2024 at 2:00 PM, Corporate Representatives 6 and 7 were asked for the W-2s for this agency and were also asked if they were paid by this agency, at which Corporate Representative 7 indicated that all W-2s come from the corporation in Ohio and no W-2s come from the agency. On 2/9/24 at 12:38 PM, Corporate Representative 5 provided 2023 W-2s. A review of Corporate Representatives 10 and 11 W-2s indicated the employer’s name and address was that of the Home Care Network, Inc. in Dayton Ohio. Corporate Representative 5 confirmed at 1:44 PM that the Employer ID number was directly tied to the Home Care Network and not directly connected to the agency in Indiana and all Indiana W-2s are affiliated with the Home Care Network in Dayton Ohio, and not the agency in Indiana.”