Topmak Health Care Services Inc.

“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 conduct an exercise to test the emergency plan or to activate the plan after an actual natural or man-made emergency annually and maintain documentation, for two (2022 and 2023) of three years reviewed. The failure placed the agency’s patients at risk of harm related to lack of organized preparation and planning for patient care and services in the event of a disaster/emergency. Findings include: During the entrance conference at 12:17 p.m. on 11/12/2024, the Admin/DON self-identified as the disaster coordinator and identified the Alt Admin/Alt DON as the alternate disaster coordinator. Record review of the undated emergency preparedness manual did not identify any records/documentation to establish that the agency had participated in a full-scale exercise that was community based every 2 years and conducted on the opposite year of the full-scale exercise, a second community-based exercise, mock drill, or tabletop exercise. The agency’s emergency preparedness records also failed to contain documentation that the agency experienced an actual or man-made emergency that required an activation of the emergency plan that would have exempted the agency from a full-scale exercise for the years 2022 and 2023. The last documented emergency events were dated 03/31/2020 for the COVID-19 pandemic, 2/10/2021 for an ice storm, and 05/28/2024 for a “weather outbreak.” The agency had an updated emergency preparedness and response plan policy that was dated 05/01/2024. During an interview on 11/15/2024 at approximately 2:30 p.m. with the Admin/DON (disaster coordinator) the surveyor reviewed the findings and asked who at the agency was responsible for the agency’s EP program. The Admin/DON replied, “Me.” The surveyor asked the Admin/DON to describe the agency’s EP program processes/policy/procedures. The Admin/DON stated that the agency started at admission with triaging the patients; “When we have a bad storm, we will call the patients. We haven’t’ had any power outages. Things have been normal. I put the date and I sign. The problem is documentation.” The surveyor asked why the agency had not completed drills, exercises, or activated the plan during emergency events to test the plan, analyzed and maintained documentation of any drills, exercises, and actual events for 2022 and 2023. The Admin/DON stated that [the Admin/DON] had looked in the EP binder and “it is not there.” The surveyor asked how the failure could adversely affect the agency’s patients. The Admin/DON replied, “Whoever doesn’t know what we have done, they would not know what to do.” Record review of agency policy titled “Emergency Preparedness and Response Plan EC.40” last reviewed 05/01/2024 read in part: “Purpose I. To ensure the Agency complies with all applicable federal, state, and local emergency preparedness requirements...POLICY... 2. Testing and Training a. The Agency will conduct exercises to test the emergency plan at least annually. The Agency will: (1) Participate in a full-scale community-based exercise every two years. If participation in a community-based exercise is not possible, a facility-based functional exercise will be conducted every two years. The Agency will document efforts to identify a full-scale community-based exercise if they did not participate in one (i.e., date, personnel, and agencies contacted and the reasons for the inability to participate in a community-based exercise). If the Agency experiences an actual natural or manmade emergency that requires activation of the emergency plan, the Agency is exempt from engaging in its next required full-scale community-based or facility-based functional exercise for one year following the onset of the emergency event. (2) Conduct an additional exercise every two years, opposite the year the full-scale community-based or facility-based functional exercise is conducted, that may include, but is not limited to the following: (a) A second full-scale community-based or facility-based functional exercise, or (b) A mock disaster drill, or (c) A tabletop exercise or workshop that includes 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 (3) The Agency will analyze the Agency’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, assess staff knowledge of emergency procedures and revise the emergency plan, as needed. (4) The Agency will document the lessons learned following their tabletop and full-scale exercises and real life emergencies and demonstrate that they have incorporated any necessary improvements in their emergency preparedness program...” Record review of agency policy titled “Emergency Preparedness and Response Plan -Addendum EC.40 “ last reviewed 05/01/2024 read in part: “...B. As part of the annual internal review, the Agency will test the response phase of the emergency preparedness and response plan in a planned drill, if not tested during an actual emergency response…””

“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 and document PIP(s) annually, for two (2022 and 2023) of two years reviewed for PIP(s), that reflected the scope, complexity and past performance of the agency’s services and operations. The failure placed the agency’s patients’ health and safety at risk if the agency did not identify and improve quality of care and service related to patient health and safety concerns. Findings include: During an interview on 11/12/2024 12:20 p.m., the surveyor requested all agency QAPI documents/reports/manuals. Review of agency’s QAPI records revealed the following: An invoice for the agency’s consultant services dated 10/29/2021. A PIP for the agency’s personal assistance services dated 08/22/2024. Client chart audit tools and member visit logs for 2024. Personnel record audit tools for 2024. A clinical summary for 2024. Continued review of the agency’s QAPI records did not reveal documentation that indicated the agency had: any quality improvement projects undertaken, the reason for conducting the projects, and the measurable progress on achieving the projects; any performance improvement projects either in development, ongoing or completed for the calendar years of 2022 and 2023. During an interview with the Admin/DON on 11/15/2024 at 2:50 p.m. the surveyor reviewed the findings and asked who was responsible for conducting the PIP(s). The Admin/DON replied, “Me.” The surveyor asked what the agency’s process was for conducting the projects. The Admin/DON stated that the agency used an external agency for their QAPI program: “They do the reports. After they leave, usually we do a meeting and put a plan in place.” The surveyor asked why the agency had not conducted PIP(s) per federal regulatory requirements and agency policy (to conduct and document the projects). The Admin/DON stated that sometimes the external agency conducts the QAPI review of the agency virtually, and “I shouldn’t wait until the surveyor gets here.” The surveyor asked how the failure could adversely affect the agency’s patients. The Admin/DON replied, “If we don’t follow the recommendations, the care that we are giving to our patients will not be sound; deficient care [is] provided to patient; [and] It would impact the quality of care.” Review of agency policy titled, “Quality Assessment Performance Improvement Plan” last reviewed 01/13/2018 read in part: “...PERFORMANCE IMPROVEMENT PROJECTS: The Governing Body determines the number and scope of distinct improvement projects to be conducted annually which reflect the scope, complexity, and past performance of the Agency’s services and operations. The Agency must document the projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects...” Review of agency policy titled, “Quality Assessment Performance Improvement Program QAPI.5” last reviewed 05.01.2024 read in part: “...III. The Agency will maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS... X. QAPI documents will be kept confidential and will be made available to State Home Health licensing agency staff on request...””

“Written notice for non-covered care CFR(s): 484.50(c)(8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure proper written notice was provided, in advance of terminating on-going care in two (Patients # 6 and 7) of two inactive patient records reviewed. The agency failed to provide Patients # 6 and 7 with the Centers for Medicare and Medicaid form titled “Notice of Medicare Non-Coverage (NOMNC)”. The failure could affect the patient’s emotional and physical health and safety and result in harm due to lack of consistent and continuing care in the patient’s post discharge needs. Findings include: Review of the agency’s patient discharge roster revealed a discharge date for Patient # 6 as 06/14/2024 and Patient # 7 as 01/19/2024. Inactive Clinical Record # 6: Record review of the clinical records for Patient # 6 revealed a POC for the certification period of 04/16/2024 to 06/14/2024. Review of the POC revealed a start of care date of 04/16/2024 with a principal diagnosis of type 2 diabetes mellitus with diabetic nephropathy (a condition where kidney function deteriorates). The POC was dated 04/16/2024 and electronically signed by the Admin/DON. The POC contained an order for skilled nursing visits two times per week for two weeks and one time per week for seven weeks beginning week of 04/16/2024. Continued review of the records revealed a discharge summary signed by the Admin/DON and dated 06/20/2024. Review of the discharge summary revealed an end of episode date of 06/14/2024. The discharge summary revealed that Patient # 6 was discharged from the agency with “100%” of goals met and “Patient remained in the community (without formal assistive services).” Further review of Patient # 6’s records did not reveal that the patient or patient representative received a proper written notice of intent to discharge no later than two days in advance of terminating on-going care on, 06/14/2024. The record did not include a written NOMNC. Inactive Clinical Record # 7: Record review of the clinical records for Patient # 7 revealed a POC for the certification period of 11/21/2023 to 01/19/2024. Review of the POC revealed a start of care date of 09/22/2023 with a principal diagnosis of hypertensive chronic kidney disease (a condition where chronic high blood pressure has caused kidney damage). The POC was dated 11/17/2023 and electronically signed by the Admin/DON. The POC contained an order for skilled nursing visits one time per week for nine weeks beginning week of 11/21/2023. Continued review of the records revealed a discharge summary signed by the Admin/DON and dated 01/28/2024. Review of the discharge summary revealed an end of episode date of 01/19/2024. The discharge summary revealed that Patient # 7 was discharged from the agency with “100%” of goals met and “Patient remained in the community (without formal assistive services).” Further review of Patient # 7’s records did not reveal that the patient or patient representative received a proper written notice of intent to discharge no later than two days in advance of terminating on-going care on, 01/19/2024. The record did not include a written NOMNC. During an interview on 11/15/2024 at 3:04 p.m. with the Admin/DON, the surveyor reviewed the above findings and asked who at the agency was responsible for providing the discharge notice. The Admin/DON stated that the RN who discharge the patient was responsible. The Admin/DON asked which RN did the discharge. The surveyor stated that the Admin/DON signed the discharge summaries. The surveyor asked what the agency process was for providing discharge notice to their patients. The Admin/DON stated that the agency gave the five-day discharge notice. The Admin/DON looked in the patients clinical records and did not identify a NOMNC for Patients # 6 and 7. The surveyor asked why the agency had not provided written notice of the intent to discharge with the NOMNC form no later than two days in advance of terminating on-going care for Patients # 6 and 7. The Admin/DON shook her head and did not answer. The surveyor asked how the failure could adversely affect the patients. The Admin/DON stated, “They won’t have any ideal idea that they are going to be discharged. It could be emotional for them.” Review of agency policy titled, “Patient/Client Transfer and Discharge Notices PE.30” last reviewed 05/01/2024 read in part: “ ... III. The Agency will deliver the Notice of Medicare Non-Coverage (an OMB-approved Medicare form) to the patient/client, or representative, at least two (2) calendar days before Medicare covered services end, or the second to last day of service if care is not provided daily... B. At least two (2) calendar days before Medicare covered services end or the second to last day of service if care is not provided daily, the Agency representative will provide the NOMNC to the patient/client, or representative (if any) when providing notice of discharge... C. If the Agency fails to give valid notice, patient/client coverage continues for at least two (2) days after the notice is received...””