Truheart Home Health

“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 ensure emergency preparedness disaster table-top exercises, drills, community drills or plan activation events were conducted for calendar years 2022 and 2023 for all patients and employees. Findings: A review of administrative records related to emergency preparedness showed no emergency preparedness disaster table-top exercises, drills, community drills or plan activation events for calendar years 2022 and 2023. On 03/20/24 at 12:00 pm, Staff A stated the agency had no emergency preparedness disaster table-top exercises, drills, community drills or plan activation events for calendar years 2022 and 2023.”

“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 utilization of QAPI data to improve program effectiveness, quality of patient care and overall program improvement for all patients and employees. Findings: A review of QAPI records for calendar years 2022 and 2023 showed no data collection sources or activities utilized in the analysis of data in the agency’s QAPI Program for calendar years 2022 and 2023. On 03/20/24 at 12:15 p.m., Staff A stated: 1. All QAPI program documentation for the agency was provided in its entirety and; 2. Documentation showed no program improvement data or analysis of collected data that showed improved quality of patient care for calendar years 2022 and 2023.”

“Program activities CFR(s): 484.65(c) (1) The HHA’s performance improvement activities must— (i) Focus on high risk, high volume, or problem-prone areas; (ii) Consider incidence, prevalence, and severity of problems in those areas; and (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure conduction of patient centered QAPI Program activities that included self-monitoring efforts and opportunities to identify problems to improve care, services and operations for all patients and employees. Findings: A review of QAPI Program documents showed no program activities for calendar year 2022 and 2023. Documentation showed no conduction of patient centered QAPI Program activities that included self-monitoring efforts and opportunities to identify problems to improve care, services and operations. On 03/20/24 at 12:15 p.m., Staff A stated: 1. The agency had no QAPI program documentation for calendar year 2022 and 01/01/23 to 04/05/23 (date of agency transfer of ownership) and; 2. The agency had no QAPI program documentation that showed ongoing QAPI program activities that included self-monitoring efforts and opportunities to identify problems to improve care, services and operations of the agency for 04/06/23 to 12/31/23.”

“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 the selection, review and reporting of ongoing PIP data through the QAPI program for all patients and employees. Findings: A review of QAPI program documents showed no PIP data reporting for calendar years 2022 and 2023. On 03/20/24 at 12:00 p.m., Staff A stated QAPI program documentation showed no PIP selection or reporting of PIP data for calendar years 2022 and 2023.”

“Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA’s governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure governing body oversite of the conduction of a patient centered QAPI program for all patients and employees. Findings: A review of administrative records showed no governing body oversite of the conduction of a patient centered QAPI program for calendar years 2022 and 2023 for the agency. On 03/20/24 at 12:30 p.m., Staff A stated: 1. Documentation showed no governing body oversite of the conduction of a patient centered QAPI program for calendar years 2022 and 2023; 2. The agency had no QAPI program documentation for calendar year 2022 and 01/01/23 to 04/05/23 (date of agency transfer of ownership) and; 3. The agency had no QAPI program documentation that showed ongoing QAPI program activities that included self-monitoring efforts and opportunities to identify problems to improve care, services and operations of the agency for 04/06/23 to 12/31/23.”

“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 ensure governing body oversite of: 1. An operating budget, capital expenditure plan and allocation of resources activities for calendar year 2022 and 2023; and 2. Agency program evaluation for calendar years 2022 and 2023 effecting all patients and staff. Findings: A review of administrative records showed no governing body over-site and responsibility for the agency’s operating budget, capital expenditure plan or agency’s program evaluation for calendar years 2022 and 2023. On 03/20/24 at 12:30 p.m., Staff A stated documentation showed no administrative records which showed evidence of ongoing governing body oversite and responsibility for the agency’s operating budget, capital expenditure plan or agency’s program evaluation for calendar years 2022 and 2023.”

“Patient/payer will no longer pay for services CFR(s): 484.50(d)(2) The patient or payer will no longer pay for the services provided by the HHA; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure advance beneficiary notice and/or HHCOC notice was provided to two (Patients #6 and 7) of eight patients. Findings: Patient #6 A review of the clinical record showed no advance notice of discharge from the agency on 01/31/24 for non-compliance. On 03/20/24 at 11:40 a.m., Staff A stated: 1. No ABN notice for patient #6 and; 2. Patient #6 should have received an ABN prior to being discharged from the agency for non-compliance. Patient #7 A review of the clinical record showed no advance notice of discharge or home health change of care notice prior to discharge from the agency on 12/31/23 for a change in insurance payer source for services. On 03/20/24 at 11:45 a.m., Staff A stated: 1. No ABN or HHCOC notices for patient #7 and; 2. Patient #7 should have received ABN and/or HHCOC notices prior to being discharged from the agency for change in insurance payer source for services.”

“Advise the patient of discharge for cause CFR(s): 484.50(d)(5)(i) (i) Advise the patient, representative (if any), the physician(s) or allowed practitioner(s), issuing orders for the home health plan of care, and the patient’s primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) that a discharge for cause is being considered; This Element is not met as evidenced by: Based on record review and interview, the agency failed to: 1. Show documentation of problems encountered by the HHA related to behaviors that impeded the HHA from providing care and services for one (Patient #6) of eight patients; 2. Educate the patient on potential health outcomes from discontinued HHA care and services for one (Patient #6) of eight patients; 3. Notify the physician of the patient’s behaviors that impeded the HHA from providing care and services for one (Patient #6) of eight patients and; 4. Inform the physician of the patient’s imminent discharge from the HHA for cause for one (Patient #6) of eight patients. Findings: Patient #6 A review of a plan of care for 01/19/24 to 03/18/24 showed an SN visit frequency of one times a week for nine weeks for SN to assess and teach pain management, assess and report changes in disease status, medication management and effectiveness. SN visit and narrative notes showed no documentation of problems encountered by the HHA related to behaviors that impeded the HHA from providing care and services, attempts to educate the patient on potential health outcomes from discontinued HHA care and services, physician notification of the patient’s behaviors that impeded the HHA from providing care and services or physician contact to inform of imminent discharge from the HHA for non-compliance prior to the discharge date of 01/31/24. On 03/20/24 at 11:40 a.m., Staff A stated there was no documentation for patient #6 of: 1. Problems encountered by the HHA related to behaviors and conditions that impeded the HHA from providing care and services; 2. Patient education of potential health outcomes from discontinued HHA care and services; 3. Physician notification of the patient’s behaviors and living conditions that impeded the HHA from providing care and services and; 4. Physician notification of the patient’s imminent discharge from the HHA for cause.”

“All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure physician orders to discontinue a home health aide visit frequency for one (Patient #5) of eight patients. Findings: Patient #5 A review of a POC dated 01/21/24 to 03/20/24 showed a home health aide visit frequency of one time a week for one week, then two times a week for eight weeks. Documentation showed a home health aide visit conducted on 01/25/24 and showed no other home health aide visits conducted after that (one visit conducted, 17 visits ordered). A SN narrative note dated 01/27/24 documented the patient declined further home health aide visits. Documentation showed no physician notification of patient declined further home health aide visits and showed no changes in orders. On 03/20/24 at 11:35 a.m., Staff A stated the SN did not document the physician notification of patient declined further home health aide visits and did not show the changes in orders were entered into the clinical record of patient #5.”

“Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure services were provided as ordered on the POC for: 1. SN to conduct assessment of patient weight every visit and notify the physician of change in patient weight for one (Patient #3) of eight patients; 2. SN to perform suprapubic catheter change using 18 French /15cc catheter for one (Patient #3) of eight patients; 3. SN to conduct assessment of patient blood pressure every visit and notify the physician of blood pressure less than 90/50 for one (Patient #3) of eight patients; 4. SN to conduct assessment wound care every visit for one (Patient #4) of eight patients and; 5. PT to conduct assessment of patient pain level every visit and notify the physician of pain level greater than seven for one (Patient #5) of eight. Findings: Patient #3 A review of the POC dated 01/04/24 to 03/03/24 showed orders for SN to conduct assessment of patient weight every visit and notify the physician of change in patient weight, perform suprapubic catheter change using 18 French /15cc catheter every month and conduct assessment of patient blood pressure every visit and notify the physician of blood pressure less than 90/50. Documentation showed no monitoring of the patient’s weight during SN visits conducted on 01/10/24, 01/19/24, 01/30/24, 02/08/24, 02/15/24, 02/20/24 and on 02/28/24; during SN visit on 01/30/24 SN changed the suprapubic catheter using a 16 French / 12 cc catheter (size not ordered in the POC) and; during SN visit on 01/10/24 the patient’s blood pressure was 98/48 documentation showed no attempt to retake the blood pressure. Documentation showed no patient refusal of weight or blood pressure monitoring, no physician notifications and showed no changes in orders. On 03/20/24 at 11:27 a.m., Staff A stated SN should have followed the POC and: 1. Monitored the patient’s weight during every visit; 2. Used a 18 French / 15 cc catheter during the suprapubic catheter change on 01/30/24 and; 3. Notified the physician of the blood pressure reading less than 90/50 on 01/10/24. Patient #4 A review of an updated POC dated 02/06/24 to 04/05/24 showed orders for SN to conduct wound care to site and complete a dressing change every visit: cleanse with soap and water, apply calcium alginate, cover with a hydrocolloid dressing and apply a Tegaderm external dressing. Documentation showed during SN visit dated 02/29/24 no wound site care and dressing change was performed as “no dressing materials available in the patient’s home”. Documentation showed no patient refusal of wound care, no physician notification and no changes in orders. On 03/20/24 at 11:30 a.m., Staff A stated SN should have followed the POC and conducted the wound site care and dressing change during the visit. Patient #5 A review of a POC dated 01/21/24 to 03/20/24, showed orders for to notify physician if patient reported pain level greater than seven of 10. PT visit notes dated 01/30/24 documented a patient reported pain level of 10/10 and on 02/14/24 documented a patient reported pain level of 10/10. Documentation showed no physician notifications or changes in orders. On 03/20/24 at 11:35 a.m., Staff A stated PT should have notified the patient reported pain levels greater than seven as ordered in the POC to the physician.”

“Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient’s discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient’s care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This Element is not met as evidenced by: Based on record reviews and interview, the agency failed to ensure a completed transfer/discharge summary was provided for two (Patients #7 and #8) of eight patients. Findings: Patient #7 A review of the clinical record documented transfer from the agency on 12/08/23 to inpatient hospital provider services with subsequent discharge from agency services on 12/31/23. Documentation showed no transfer/discharge summary was provided to the inpatient hospital service provider. Patient #8 A review of the clinical record documented transfer from the agency on 02/25/24 to inpatient hospital provider services with subsequent discharge from agency services. Documentation showed no transfer/discharge summary was provided to the inpatient hospital service provider. On 03/20/24 at 11:45 a.m., Staff A stated documentation showed no transfer/discharge summary was sent to the receiving service providers for patients #7 and #8.”