Family Care Home Health, 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 ensure emergency preparedness disaster table-top exercises, drills, community drills or plan activation events from 05/12/23 to 01/28/25 for all patients and employees. Findings: A review of emergency preparedness records showed no emergency preparedness disaster table-top exercises, drills, community drills or plan activation events from 05/12/23 to 01/28/25. On 01/29/25 at 1:00 p.m., Staff C stated the emergency preparedness program for the agency showed no table-top exercises, drills, community drills or plan activation events from 05/12/23 to 01/28/25.”

“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 interviews, the agency failed to ensure utilization of quality indicator data for the QAPI program; to improve program effectiveness, quality of patient care, and overall program improvement for all patients and employees. Findings: A review of QAPI records showed no data collection sources or activities utilized in the analysis of data in the agency’s QAPI Program for calendar year 2023. On 01/29/25 at 1:00 p.m., Staff A stated: 1. All QAPI program documentation for the agency was provided in its entirety; and 2. Documentation showed no improvement data or analysis of collected data that showed improved quality of patient care for calendar year 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 calendar year 2023 for all patients and employees. Findings: A review of governing body meeting minute records showed no governing body oversite of the conduction of a patient centered QAPI program for calendar year 2023. On 01/29/25 at 1:00 p.m., Staff A stated administrative governing body meeting minute records showed no documentation of governing body oversite of the conduction of a patient centered QAPI program for calendar year 2023.”

“Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA’s quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Infection Control Program surveillance data was included in QAPI program activities for all patients and employees. Findings: A review of QAPI administrative records showed no documentation of infection control surveillance data through the QAPI program for calendar year 2023. On 01/29/25 at 1:00 p.m., Staff A stated infection surveillance activities were not reported through the agency’s QAPI program for calendar year 2023.”

“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 the agency’s program evaluation for calendar year 2024 and operating budget, and capital expenditure plan for calendar years 2023 for all patients and employees. Findings: A review of governing body records showed no governing body oversite for agency program evaluation for calendar year 2024 and operating budget, and capital expenditure plan for calendar years 2023 On 01/29/25 at 1:00 p.m., Staff C stated documentation showed no governing body oversite for the agency’s program evaluations, operating budgets, and capital expenditure plans for calendar years 2023 and 2024.”

“RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient’s return home, or on the physician or allowed practitioner - ordered start of care date. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure a SOC assessment was conducted within 48 hours of referral for two (Patients #2 and #6) of seven patients. Findings: Patient #2 A review of the clinical record showed the agency received referral information on 09/02/24 and the SOC assessment occurred on 09/10/24 (8 days). Documentation showed no patient refusal of SOC assessment, no physician notification of a delay in SOC and no change in orders. Patient #6 A review of the clinical record showed the agency received referral information on 10/01/24 and the SOC assessment occurred on 10/05/24 (4 days). Documentation showed no patient refusal of SOC assessment, no physician notification of a delay in SOC and no change in orders. On 01/29/25 at 11:45 a.m. to 12:42 p.m., Staff B stated the SOC assessments for patients #2 and #6 should have been conducted within 2 days of referral or the SOC date ordered by the physician provider.”

“Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient’s mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure individualized patient POC included: 1. Updated physician orders for each 60-day certification period for four (Patient #1, 2, 3 and #4) of seven patients; 2. Specific SN frequency and duration for each 60-day certification period for one (Patient #2) of seven patients and; 3. SN treatment/interventions or last changed/treatment due date for Porta-Cath management for two (Patients #4 and #5) of seven patients. Findings: Patient #1 A review of the POC dated 12/03/24 to 01/31/25 showed orders for SN to provide assessment, instruction of interventions and monitoring of health conditions. POC documentation showed the physician’s orders were dated from 10/04/24 and were not updated for the current certification period beginning on 12/03/24. Documentation showed no physician notification and no changes in orders. On 02/03/25 at 11:20 a.m., Staff B stated the POC orders should have been updated to reflect the current certification period. Patient #2 A review of the POC dated 01/08/25 to 03/08/25 showed orders for SN to provide assessment, instruction of interventions and monitoring of health conditions. POC documentation showed the physician’s orders were dated from 11/09/24 and were not updated for the current certification period beginning on 01/08/25; and showed two different SN frequencies and durations of one time a week for nine weeks and two times a week for six weeks, then one time a week for three weeks. Documentation showed no physician notification and no changes in orders. On 02/03/25 at 11:45 a.m., Staff B stated the POC orders should have been updated to reflect the current certification period. Patient #3 A review of the POC dated 12/01/24 to 01/29/25 showed orders for SN to provide assessment, instruction of interventions and monitoring of health conditions. POC documentation showed the physician’s orders were dated from 10/02/24 and were not updated for the current certification period beginning on 12/01/24. Documentation showed no physician notification and no changes in orders. On 02/03/25 at 11:52 a.m., Staff B stated the POC orders should have been updated to reflect the current certification period. Patient #4 A review of the POC dated 01/13/25 to 03/13/25 showed orders for SN to provide assessment, instruction of interventions and monitoring of health conditions. POC documentation showed the physician’s orders were dated from 11/14/24 and were not updated for the current certification period beginning on 01/13/25 and SN treatment/interventions for Porta-Cath management showed no last changed or treatment due date. Documentation showed no physician notification and no changes in orders. On 02/03/25 at 12:25 a.m., Staff B stated the POC orders should have been updated to reflect the current certification period. Patient #5 A review of the POC dated 01/01/25 to 03/01/25 showed orders for SN to provide assessment, instruction of interventions and monitoring of health conditions. POC documentation showed physician’s orders dated from 11/09/24 and were not updated for the current certification period beginning on 01/08/25 and SN treatment/interventions for Porta-Cath management showed no last changed or treatment due date. Documentation showed no physician notification and no changes in orders. On 02/03/25 at 12:35 a.m., Staff B stated the POC orders should have been updated to reflect the current certification period.”

“Participate in the HHA’s QAPI program; CFR(s): 484.75(b)(8) Participation in the HHA’s QAPI program; and This Element is not met as evidenced by: Based on a record review and interview, the agency failed to ensure multi-disciplined skilled professional staff were available to participate and provide input into the agency’s QAPI program for all patients and employees. Findings: A review of administrative records showed no multi-disciplined skilled professional staff participation in QAPI activities for calendar years 2023 and 2024. On 01/29/25 at 1:00 p.m., Staff A stated QAPI program activities had no multi-disciplined skilled professional staff participation for the agency.”

“Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure clinical visit note documentation was complete and accurate for two (Patients #3 and #4) of seven patients. Findings: Patient #3 A review of the POC dated 12/01/24 to 01/29/25 showed orders for SN to assess and monitor health conditions and perform wound care interventions to multiple wound sites each visit. SN visit notes dated 12/12/24, 12/16/24, 12/23/24, 12/30/24 and 01/13/25 documented no wound site interventions and documented the patient continued intravenous antibiotic infusions, when the PICC line and the intravenous antibiotic infusions were discontinued on 12/04/24. On 01/29/25 at 11:52 a.m., Staff B stated SN clinical visit notes for 12/12/24, 12/16/24, 12/23/24, 12/30/24 and 01/13/25 did not document wound site interventions and should not have included the continued instruction of the intravenous PICC line and antibiotic infusions. Patient #4 A review of the POC dated 12/01/24 to 01/29/25 showed orders for SN to assess and monitor health conditions and perform wound care interventions to the wound site each visit. SN visit notes dated 01/13/25, 01/20/25 and 01/27/25 documented no wound site interventions or wound site assessment. On 01/29/25 at 12:25 p.m., Staff B stated SN clinical visit notes for 01/13/25, 01/20/25 and 01/27/25 did not document wound site interventions or assessment.”

“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 interviews, the agency failed to ensure completed transfer/discharge summaries were provided to receiving service providers for three (Patients #1, 6 and #7) of seven patients. Findings: Patient #1 A review of the clinical record showed transfer from the agency on 12/09/24 to inpatient hospital provider services. Documentation showed no transfer summary was provided to the receiving inpatient hospital service provider. Patient #6 A review of the clinical record showed discharge from the agency on 11/27/24. Documentation showed a discharge summary was not provided to the physician until 12/04/24 (seven days) after the patient’s discharge from the agency. Patient #7 A review of the clinical record showed transfer from the agency on 07/03/24 to inpatient hospital provider services. Documentation showed no transfer summary was provided to the receiving inpatient hospital service provider. On 01/29/25 at 11:20 a.m. to 12:52 p.m., Staff B stated documentation showed no transfer/discharge summary was sent to the receiving service providers for patients 1, 6 and #7.”