Every finding on record at Santec International Corporation

A Recertification survey was conducted with the Administrator on 08/11/2023 at 5:00 PM. Census: Licensed and Certified- 0 Licensed Home Health- 0 Personal Assistance Services- 27 Acronyms used: ADR - Additional Document Request CMS – Centers for Medicare & Medicaid Services HHA – Home Health Agency REV - Revised

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 review the agency’s response to and maintain documentation of emergency events, and revise the emergency plan, as needed after each actual emergency response for 3 (2021, 2022, and 2023) of 3 years of the survey review period (12/10/2020 to 08/11/2023). The agency was unable to evaluate the effectiveness of the plan and to update the plan as needed to ensure staff and clients were able to complete actions necessary for safety during emergencies. During the entrance conference on 08/08/2023 at 3:15 PM the surveyor provided a list of documents needed for review during the survey to the Administrator. The list included the agencies Emergency preparedness plan and documents for 2021, 2022, and 2023. Review of the emergency preparedness binder documents provided by the Administrator on 08/11/2023 revealed no evidence the agency implemented and evaluated the effectiveness of the emergency preparedness plan during the severe winter storm in February 2021, or the severe winter storm in February 2022. An interview was conducted on 8/11/23 at 5:00 PM with the Administrator and Office Manager. The surveyor asked who was designated as the agency’s Disaster Coordinator. The Administrator stated she was the Disaster Coordinator, and she was responsible for developing and maintaining the Emergency Preparedness plan including reviews and updates. The surveyor shared the findings of the review of the emergency preparedness documents and asked for the evidence of the implementation and internal reviews of the agency’s Emergency Preparedness plan for the severe winter storms of February 2021 and February 2022. The Administrator stated the agency had not implemented disaster plans for the two events (severe ice storms 2021 and 2022) because they were overwhelmed with an ongoing CMS ADR Audit. Agency policy read in part: 7.8 EMERGENCY PREPAREDNESS AND RESPONSE PLAN REV:1 dated 1/29/2020 page 14. PURPOSE: The Agency will develop, maintain, and implement a written Emergency Preparedness and Response Plan (Plan), based on the Agency’s risk assessment. It establishes a plan of action for providing continuous patient care and continuous business operations in the event of a disaster. The Agency will be in compliance with the “Emergency Preparedness Planning and Implementations”, Licensing Standards for Home and Community Support Services Agencies, 97.256. Definitions: 1. Disaster- A sudden event, such as an accident or natural catastrophe, an occurrence or imminent threat of widespread or severe damage that may cause loss of life or loss of property resulting from a natural or man-made cause, such as fire, flood, earthquake. Wind, storm, wave action, oil spill or other water contamination, epidemic, air contamination, infestation, explosion, riot, hostile military or paramilitary action, or energy emergency. Policy Section 3. RV:1 dated 1/29.2020 page 17. Communication Plan: The Agency will develop and maintain an emergency preparedness communication plan that complies with Federal, State, and Local laws and must be reviewed and updated at least annually.

A Recertification survey was conducted with the Administrator on 08/11/2023 at 5:00 PM. Census: Licensed and Certified- 0 Licensed Home Health- 0 Personal Assistance Services- 27 Acronyms used: ADR - Additional Document Request CMS – Centers for Medicare & Medicaid Services HHA – Home Health Agency QAPI- Quality Assurance Performance Improvement PIP- Performance Improvement Project REV - Revised

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 record review and interview, the agency failed to maintain a Quality Improvement / Performance Improvement program to measure, review, track and communicate quality indicators, including a representative sample of services furnished in both active and discharged records, a determination that services have been performed as outlined in the individualized services, and other aspects of performance that would enable the agency to assess outcomes that are measurable and have a written plan of implementation for three of the three-year period review (12/10/2020 to 8/11/2023). This failure caused the agency to have no effective mechanism to monitor, evaluate and improve care and services to agency patients. The surveyor requested QAPI program documents during the entrance conference on 08/08/2023 at 3:15 PM. A review of QAPI Binder documents provided by the Administrator on 08/10/2023 at 2:00 PM revealed: There was no evidence of completed QAPI activities for 2021, 2022, and 2023. There were no samples of auditing services furnished to patients in active and discharged charts. In an interview with the Administrator on 08/10/2023 at approximately 4:00 PM, the surveyor reviewed the findings and asked about the agency’s lack of QAPI activities. The Administrator stated, “In April of 2021, we had an Additional Document Request (ADR) from CMS for all our Medicare patients, and we became very overwhelmed. In November of 2021 our Medicare provider number was suspended. We thought we did not have to do any QAPI sense our Medicare provider number was suspended.” The surveyor asked the administrator who was responsible for reviewing the agency’s QAPI activities. The administrator stated she was responsible for reviewing the QAPI activities. Agency policy provided by, Accurate QA Solutions, quoted in part, dated REV:1/29/2020, “QUALITY ASSESSMENT PERFORMANCE IMPROVEMENT PLAN” 9.1 Page 2, The Agency will develop, implement, and maintain an effective, ongoing HHA wide, data-driven Quality Assessment Performance Improvement Plan (QAPI) program. The Agency’s governing body will ensure that the program reflects the complexity of its organization and services; involves all Agency 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 Agency’s performance across the spectrum of care; including the prevention and reduction of medical errors. The Agency will maintain documentary evidence of the QAPI program and will be able to demonstrate the program operation to CMS. “QUALITY ASSESSMENT PERFORMANCE IMPROVEMENT PLAN” 9.1 Page 6, The program will be evaluated, reviewed, and updated or revised at least twice within the calendar year, or more often if needed, by the governing board.

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 conduct performance improvement projects annually for three of the three-year period review (12/10/2020 to 08/11/2023). This failure potentially subjected patients to substandard care when the agency had not evaluated the care and operations and developed plans to improve performance, and or address any issues that were or could have impacted patient care. The surveyor requested the PIP program documents during the entrance conference on 08/08/2023 at 3:15 PM.. A review of QAPI Binder documents provided by the Administrator on 08/09/2023 at 2:00 PM revealed no Professional Advisory Committee meetings for 2021, 2022 or 2023 to date (08/11/2023). No evidence of performance improvement projects for 2021, 2022 and 2023 was provided. In an interview with the Administrator on 08/10/2023 at approximately 4:00 PM, the surveyor reviewed the findings and asked about the agency’s lack of QAPI and Performance Improvements Project activities. The Administrator stated, “In April of 2021, we had an Additional Document Request (ADR) from CMS for all our Medicare patients, and we became very overwhelmed. In November of 2021 our Medicare provider number was suspended. We thought we did not have to do any QAPI since our Medicare provider number was suspended.” The surveyor asked the administrator who was responsible for reviewing the agency’s QAPI activities. The administrator stated she was responsible for reviewing the QAPI activities. Agency Policy, quoted in part, dated 01/29/2020, “9.3 PERFORMANCE IMPROVING PROCESS: Data Collection… Page 9, The Agency will collect data to monitor performance of areas targeted for study and to determine effectiveness of the change. Data will be collected in a uniform, systemic way to: Establish a performance baseline; Describe process performance and stability; Describe the dimensions of performance relevant to functions, process, and outcomes; Identify areas for more focused data collection and sustain improvement.”