University Home Care, Inc.

“Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.542, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms “facility” or “facilities” in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This Condition is not met as evidenced by: Based on record review and interview, the agency failed to ensure the emergency preparedness plan was reviewed and updated at least every 2 years (See E0006); failed to maintain an emergency preparedness plan based on both an agency-based and community-based risk assessments for their relocation to Livonia (See E0006); failed to develop written emergency preparedness policies and procedures that were based on an emergency preparedness plan, risk assessment, and communication plan relevant to their current location in Livonia (See E0013); failed to develop and maintain an Emergency Preparedness communication plan that reflected current staff names and contact information and contact information for local emergency officials in Livonia (See E0029); and failed to maintain documentation of exercises conducted to test the emergency plan annually (See E0039). Findings include: The cumulative effect of these systemic problems results in the agency’s inability to ensure the provision of quality health care in a safe environment for the Condition of Participation at 42 CFR 484.102, Emergency Preparedness.”

“Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This Condition is not met as evidenced by: Based on record review and interview, the agency failed to ensure skilled professionals performed assessments of the patient’s health status and needs in 1 of 7 (P-4) records reviewed (See G706); failed to ensure skilled professionals provided services as ordered by the physician in the plan of care for 4 of 7 (P- 1, 3, 4, 7) records reviewed (See G710); failed to ensure skilled professionals prepared clinical notes for 1 of 7 (P-5) records reviewed (See G716); and failed to ensure the skilled nurse communicated with the physician regarding wound vac dressing coming off for 1 of 1 (P-4) records reviewed (See G718). Findings include: The cumulative effect of these systemic problems resulted in the Home Health Agency’s inability to ensure the provision of quality health care in a safe environment for the Condition of Participation at 42 CFR §484.75: Skilled professional services.”

“Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the emergency preparedness plan was reviewed and updated at least every 2 years and failed to maintain an emergency preparedness plan based on both an agency-based and community-based risk assessments for their relocation to Livonia. This deficient practice could negatively affect the health and safety of the agency’s 8 current patients in the event of an actual emergency Findings include: During the entrance conference on 1/8/24 at 10:08 a.m., the administrator (Staff-A) explained that the agency was previously located in Dearborn and had moved to a new location in Livonia just before Christmas (2023). On 1/11/24, the agency’s Emergency Preparedness Planning binder was reviewed. Documentation indicates that the hazard and vulnerability assessment was last revised and updated on 3/2020, which was more than 3 years ago. There was no indication that the agency had developed an emergency preparedness plan based on both an agency-based and community-based risk assessments for the current Livonia location. The findings were reviewed with and acknowledged by Staff-A during an interview on 1/11/24 at 11:20 a.m. Staff-A explained that she was unaware of the requirement that the emergency preparedness plan was to be reviewed and updated at least every 2 years.”

“Development of EP Policies and Procedures CFR(s): 484.102(b) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to develop written emergency preparedness policies and procedures that were based on an emergency preparedness plan, risk assessment, and communication plan relevant to their current location in Livonia, resulting in the agency’s inability to implement appropriate emergency actions. This deficient practice could negatively affect the health and safety of the agency’s 8 current patients in the event of an actual emergency. Findings include: On 1/11/24, the agency’s Emergency Preparedness documentation was reviewed. During the review, it was noted that there was no documented evidence of emergency preparedness policies and procedures that were based on an emergency preparedness plan, a documented risk assessment, and communication plan relevant to their current location in Livonia. The agency relocated to Livonia just before Christmas (2023). The hazard and vulnerability assessment was last revised on 3/2020 when the agency was in Dearborn. The findings were reviewed with and acknowledged by the Administrator (Staff-A) during an interview on 1/11/24 at 11:20 a.m.”

“Development of Communication Plan CFR(s): 484.102(c) §403.748(c), §416.54(c), §418.113(c), §441.184(c), §460.84(c), §482.15(c), §483.73(c), §483.475(c), §484.102(c), §485.68(c), §485.542(c), §485.625(c), §485.727(c), §485.920(c), §486.360(c), §491.12(c), §494.62(c). (c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an Emergency Preparedness communication plan that reflected current staff names and contact information for local emergency officials in Livonia, resulting in the agency’s inability to ensure the coordination of patient care during an emergency. This deficient practice could negatively affect the health and safety of the agency’s 8 current patients admitted to the agency in the event of an actual emergency. Findings include: On 1/11/24, the agency’s Emergency Preparedness documentation was reviewed. During the review, it was noted that the agency’s Staff Call Down List included the names and contact information of six employees. Five of the six names listed were no longer employed at the agency. The agency’s Emergency Preparedness Planning binder failed to include a Staff Call Down List with the names and contact information for current employees and staff providing services under arrangement. The current emergency contact list included the phone numbers for police, fire, and local emergency manager in Dearborn. The agency is no longer located in Dearborn. The agency failed to update the communication plan to reflect the local emergency contact information for Livonia. The findings were reviewed with the Administrator (Staff-A) during an interview on 1/11/24 at 11:20 a.m. Staff-A acknowledged that the Staff Call Down List was not up to date and that the local emergency contact information had not been updated.”

“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 maintain documentation of exercises conducted to test the emergency plan annually, resulting in the agency’s inability to implement appropriate emergency actions. This deficient practice could negatively affect the health and safety of the agency’s 8 current patients in the event of an actual emergency. Findings include: On 1/11/24, the agency’s Emergency Preparedness documentation was reviewed. During the review, it was noted that there was no documentation of an actual emergency or exercises to test the agency’s emergency plan annually. The findings were reviewed with the Administrator (Staff-A) during an interview on 1/11/24 at 11:20 a.m. Staff-A presented a printout of a table-top exercise. The date of the table-top exercise was not noted on the document. Staff-A was queried for documentation of staff that attended the table-top exercise. No documentation of attendance was provided. Staff-A replied that the person(s) who do the agency’s credentialing were fine with the printout of the table-top exercise and no additional documentation was required. Staff-A explained that she discussed the table-top scenario with staff but was unable to provide documentation of the date of the table-top exercise and documentation of attendance.”

“Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to provide occupational therapy services in 1 of 7 (P-3) records reviewed, resulting in unmet care needs for this patient. Findings include: P-3: This 79-year-old patient was admitted to home care on 12/15/23 with diagnoses of diseases of the spinal cord, hypertension, and diabetes mellitus. During record review on 1/9/24, it was noted that the physician referral, dated 12/4/23, ordered physical therapy (PT) and occupational therapy (OT). The start of care assessment, dated 12/15/23, was completed by PT and states the patient requires assistance for grooming, dressing upper body, and dressing lower body. The plan of care states N/A for OT. There was no evidence that OT was offered or that the physician was notified. This finding was reviewed and acknowledged by the administrator (Staff-A) during an interview on 1/10/24 at 2:00 p.m.”

“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 document the reasons for conducting performance improvement projects undertaken and the measurable progress achieved on these projects, resulting in the potential for poor quality outcomes for the 51 patients admitted to the agency in the past 12 months. Findings include: On 1/11/24, the agency provided for review, a binder titled QAPI (Quality Assessment and Performance Improvement). Quarterly minutes were reviewed from 4/1/23, 7/1/23, 10/1/23, and 1/2/24. QAPI initiatives included improvement of shortness of breath, acute care hospitalization, improvement of muscle movement, improvement in management of oral medication, and completing QAPI’s as required. There was no documented evidence of the reasons for selecting these initiatives and the measurable progress toward achieving a goal. This finding was reviewed and acknowledged by the administrator (Staff-A) during an interview on 1/11/24 at 11:40 a.m.”

“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 governing body failed to ensure the agency developed, implemented, and maintained an agency-wide, data driven Quality Assessment and Performance Improvement program from 2021 through 2023, resulting in the lack of oversight by the governing body to ensure patient safety and quality of care improvements for the 51 patients admitted to the agency in the past 12 months. Findings include: On 1/11/24, the agency provided for review, a binder titled QAPI (Quality Assessment and Performance Improvement). The date of the last governing body meeting minutes was 7/24/20. There was no documented evidence the governing body had responsibility or oversight of the agency’s QAPI program. This finding was reviewed and acknowledged by the administrator (Staff-A) during an interview on 1/11/24 at 11:40 a.m.”

“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 the initial assessment visit was conducted within 48 hours of referral for 4 of 7 (P-3, 4, 5, 7) records reviewed, resulting in a delay in determining the immediate care and support needs for these patients. Findings include: P-3: This 79-year-old patient was admitted to home care on 12/15/23 with diagnoses of diseases of the spinal cord, hypertension, and diabetes mellitus. During record review on 1/9/24, it was noted that the physician order for home care was dated 12/4/23. The start of care assessment was conducted 11 days after the date of referral. There was no evidence that the physician had been notified of the reason for the delay. This finding was reviewed and acknowledged by the administrator (Staff-A) during an interview on 1/10/24 at 2:00 p.m. P-4: This patient was admitted to home care on 12/14/23 with diagnoses of status post right iliac thrombectomy (surgery to remove a blood clot) with femoral below the knee bypass (creates a new route for blood flow to lower leg). The patient was hospitalized at the Veteran Affairs hospital from 11/23/23 to 12/10/23. The agency received the referral from the hospital on 12/01/23. The patient was discharged from the hospital on 12/10/23 and returned home. During record review on 1/9/24, it was noted that the initial assessment was conducted by the registered nurse on 12/14/23, which is 4 days after the patient was discharged home. There was no documentation to indicate the patient’s discharge from the hospital was delayed and no documentation to indicate the patient had requested a delay in home care services. P-5: This 84-year-old patient was admitted to home care on 12/13/23 with a diagnosis of left shoulder pain after a recent fall on the sidewalk. The referral for home care was fax stamped as received at the agency on 12/6/23. During record review on 1/8/24, it was noted that the initial assessment was conducted by the physical therapist on 12/13/23, which is 7 days after receiving the referral. There was no documentation to indicate the patient had requested a delay in home care services and no documentation to indicate the physician was informed of and approved the delay in care. P-7: This patient was admitted to home care on 6/2/23 with a diagnosis of post operative surgical wound infection. The referral for home care was fax stamped as received at the agency on 5/24/23. The referral states the patient has an open abdominal wound that requires twice daily wet to dry dressing changes. During record review on 1/8/24, it was noted that the initial assessment was conducted by the registered nurse on 6/2/23, which is 9 days after receiving the referral. A physician order dated 5/30/23 was written by the registered nurse and states that the patient is to start care the week of 5/30/23 due to authorization approval and that the physician’s office was notified and approved the delay. There was no documentation to indicate the physician was notified and approved the delay in care from the date of the referral on 5/24/23 to 5/29/23. The physician was not notified of the delay until 5/30/23 when the agency received authorization to provide care. It is unclear who provided twice daily wound care for this patient from the date of hospital discharge/home care referral on 5/24/23 to the start of home care on 6/2/23. The above findings were reviewed with and acknowledged by the Administrator (Staff-A) during an interview on 1/9/24 at 2:20 p.m. P-4: This patient was admitted to home care on 12/14/23 with diagnoses of status post right iliac thrombectomy (surgery to remove a blood clot) with femoral below the knee bypass (creates a new route for blood flow to lower leg). The patient was hospitalized at the Veteran Affairs hospital from 11/23/23 to 12/10/23. The agency received the referral from the hospital on 12/01/23. The patient was discharged from the hospital on 12/10/23 and returned home. During record review on 1/9/24, it was noted that the initial assessment was conducted by the registered nurse on 12/14/23, which is 4 days after the patient was discharged home. There was no documentation to indicate the patient’s discharge from the hospital was delayed and no documentation to indicate the patient had requested a delay in home care services. P-5: This 84-year-old patient was admitted to home care on 12/13/23 with a diagnosis of left shoulder pain after a recent fall on the sidewalk. The referral for home care was fax stamped as received at the agency on 12/6/23. During record review on 1/8/24, it was noted that the initial assessment was conducted by the physical therapist on 12/13/23, which is 7 days after receiving the referral. There was no documentation to indicate the patient had requested a delay in home care services and no documentation to indicate the physician was informed of and approved the delay in care. P-7: This patient was admitted to home care on 6/2/23 with a diagnosis of post operative surgical wound infection. The referral for home care was fax stamped as received at the agency on 5/24/23. The referral states the patient has an open abdominal wound that requires twice daily wet to dry dressing changes. During record review on 1/8/24, it was noted that the initial assessment was conducted by the registered nurse on 6/2/23, which is 9 days after receiving the referral. A physician order dated 5/30/23 was written by the registered nurse and states that the patient is to start care the week of 5/30/23 due to authorization approval and that the physician’s office was notified and approved the delay. There was no documentation to indicate the physician was notified and approved the delay in care from the date of the referral on 5/24/23 to 5/29/23. The physician was not notified of the delay until 5/30/23 when the agency received authorization to provide care. It is unclear who provided twice daily wound care for this patient from the date of hospital discharge/home care referral on 5/24/23 to the start of home care on 6/2/23. The above findings were reviewed with and acknowledged by the Administrator (Staff-A) during an interview on 1/9/24 at 2:20 p.m. P-3: This 79-year-old patient was admitted to home care on 12/15/23 with diagnoses of diseases of the spinal cord, hypertension, and diabetes mellitus. During record review on 1/9/24, it was noted that the physician order for home care was dated 12/4/23. The start of care assessment was conducted 11 days after the date of referral. There was no evidence that the physician had been notified of the reason for the delay. This finding was reviewed and acknowledged by the administrator (Staff-A) during an interview on 1/10/24 at 2:00 p.m.”

“5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient’s immediate needs, but no later than 5 calendar days after the start of care. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment was completed within 5 calendar days of the start of care in 1 of 7 (P-1) records reviewed, resulting in a delay in determining the immediate care and support needs for this patient. P-1: This 79-year-old patient was admitted to home care on 1/27/23 with diagnoses of multiple sclerosis, chronic pain, and sciatica. During record review on 1/8/24, it was noted this patient was ordered skilled nursing, physical, and occupational therapy. Skilled nursing completed the start of care assessment on 1/27/23 and physical therapy evaluated the patient on 1/31/23. Occupational therapy evaluation was on 2/2/23, 7 days after the start of care. There was no evidence that the physician had been notified of the reason for the delay. This finding was reviewed and acknowledged by the administrator (Staff-A) during an interview on 1/10/24 at 11:00 a.m.”

“Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient’s current health, psychosocial, functional, and cognitive status; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment accurately reflected the patient’s current health status at the time of admission to home care for 3 of 7 (P-1, 2, 5) records reviewed, resulting in incomplete clinical information to aide in determining the needs of the patient and for measuring progress toward goals/outcomes. Findings include: P-5: This 84-year-old patient was admitted to home care on 12/13/23 with a diagnosis of left shoulder pain after a recent fall on the sidewalk. During record review on 1/8/24, it was noted that the comprehensive assessment conducted by the physical therapist on 12/13/23 failed to include primary and other diagnoses to accurately reflect the patient’s current health status. The findings were reviewed with and acknowledged by the Administrator (Staff-A) during an interview on 1/9/24 at 2:20 p.m. P-1: This 79-year-old patient was admitted to home care on 1/27/23, with diagnoses of multiple sclerosis, chronic pain, and sciatica. During record review on 1/8/24, it was noted that the start of care (SOC) assessment dated 1/27/23, documented under “Primary Diagnoses & Other Diagnoses,” that all 10 diagnoses had the same date of onset, 1/27/23. A few of the other diagnoses listed include chronic pain syndrome, sarcopenia (loss of muscle and strength), and history of falling. These diagnoses are indicative of long-term, chronic health issues. There was no information found in the record to indicate that these other diagnoses were new as of 1/27/23 or that the patient had experienced exacerbations. This finding was reviewed and acknowledged by the administrator (Staff-A) during an interview on 1/10/24 at 11 a.m. P-2: This 79-year-old patient was admitted to home care on 12/27/23, with diagnoses of chronic kidney disease, chronic obstructive pulmonary disease (COPD), and diabetes. During record review on 1/8/24, it was noted that the start of care (SOC) assessment dated 12/27/23, documented under “Primary Diagnoses & Other Diagnoses,” the primary diagnosis of chronic kidney disease and listed only one diagnosis under “other” of COPD. The start of care assessment failed to include the patient’s medical history of type 2 diabetes, dependence on renal dialysis, diabetic neuropathy, cancer of the digestive system, dependence on supplemental oxygen, glaucoma, or cataract, which were found with the referral from the physician. The administrator (Staff-A) stated these diagnoses will be added when the chart goes through QA (quality assurance) during an interview on 1/10/24 at 2:00 p.m. This finding was reviewed and acknowledged by Staff-A during an interview on 1/10/24 at 2:00 p.m.”

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment included a review of all medications to determine any duplicate therapy or adverse effects, failed to ensure the Registered Nurse provided oversight of the review process, and failed to ensure the physician was notified of potential drug interactions or duplicate therapy in 7 of 7 (P-1, 2, 3, 4, 5, 6, 7) records reviewed, resulting in the potential for harmful medication effects for all patients serviced by this agency. Findings include: P-4: This patient was admitted to home care on 12/14/23 with diagnoses of status post right iliac thrombectomy (surgery to remove a blood clot) with femoral below the knee bypass (creates a new route for blood flow to lower leg). During record review on 1/9/24, it was noted on the 12/14/23 comprehensive assessment completed by the registered nurse the Drug Regimen Review (section M2001) indicates no issues found during review. On 1/9/24, the agency’s medical record software was utilized to run a medication interaction report. The report notes 3 duplicate drug therapies and 4 drug-drug potential interaction risks. There was no documentation to indicate the nurse conducted a review of the patient’s medications and was aware of the duplicate drug therapies and the potential drug interactions. There was no documentation that the physician was informed. The findings were reviewed with the Administrator (Staff-A) during an interview on 1/9/24 at 2:20 p.m. Staff-A explained that staff are to notify the physician of duplicate drug therapy and drug-drug interactions. P-5: This 84-year-old patient was admitted to home care on 12/13/23 with a diagnosis of left shoulder pain after a recent fall on the sidewalk. During record review on 1/8/24, it was noted on the 12/13/23 comprehensive assessment completed by the physical therapist the Drug Regimen Review (section M2001) indicates no issues found during review. On 1/9/24, the agency’s medical record software was utilized to run a medication interaction report. The report notes 6 drug-drug potential interaction risks. The medication review acknowledgement was signed by the physical therapist there was no documentation to indicate the medications were reviewed by a registered nurse. There was no documentation that the physician was informed of the 6 drug-drug potential interaction risks. P-6: This 78-year-old patient was admitted to home care on 1/3/24 with diagnoses of multiple sclerosis (MS) and migraine headaches. During record review on 1/8/24, it was noted on the 1/3/24 comprehensive assessment completed by the registered nurse the Drug Regimen Review (section M2001) indicates yes, issues found during review. There is no documentation to indicate what the issues are and no documentation the physician was notified of the drug regimen review issues. During a joint survey home visit with the registered nurse on 1/10/24 at 10:00 a.m., the nurse and patient were discussing the patient’s medications for MS: Gabapentin and Baclofen. This surveyor asked the patient how long she has been on Gabapentin and Baclofen. The patient replied she has been on these medications for about 2 years. A review of the plan of care, the medication reconciliation, and the medication profile failed to include the patient’s medications Gabapentin and Baclofen. The nurse failed to ensure the comprehensive assessment included a review of all the patient’s medications. P-7: This patient was admitted to home care on 6/2/23 with a diagnosis of post operative surgical wound infection. During record review on 1/8/24, it was noted on the 6/2/23 comprehensive assessment completed by the registered nurse the Drug Regimen Review (section M2001) indicates no issues found during review. On 1/9/24, the agency’s medical record software was utilized to run a medication interaction report. The report notes 2 duplicate drug therapies and 3 drug-drug potential interaction risks. There was no documentation to indicate the nurse conducted a review of the patient’s medications and was aware of the duplicate drug therapies and the potential drug interactions. There was no documentation that the physician was informed. P-1: This 79-year-old patient was admitted to home care on 1/27/23, with diagnoses of multiple sclerosis, chronic pain, and sciatica. During record review on 1/8/24, it was noted that the start of care assessment dated 1/27/23 stated issues were found during drug regimen review while the patient medication record stated there were no discrepancies and no interactions found. A medication interactions report was generated through the electronic medical record (EMR) software that indicated duplicate therapies between Tylenol and oxycodone and with amlodipine, which was entered twice. There was no evidence that the physician was notified of the duplicate therapies. It was also noted that the plan of care failed to list any allergies, while the referral and records from the primary care provider indicated the patient is allergic to penicillin. This finding was reviewed and acknowledged by the administrator (Staff-A) during an interview on 1/10/24 at 11:00 a.m. P-2: This 79-year-old patient was admitted to home care on 12/27/23, with diagnoses of chronic kidney disease, chronic obstructive pulmonary disease (COPD), and diabetes. During record review on 1/8/24, it was noted that the start of care assessment dated 12/27/23 stated no issues found during drug regimen review while the patient medication record stated the RN will discuss the medications with the physician the following day. A medication interactions report was generated through the electronic medical record (EMR) software that indicated duplicate therapy between Brimonidine and Dorzolamide ophthalmic solutions. There was no evidence that the physician was notified of the duplicate therapies. This finding was reviewed and acknowledged by Staff-A during an interview on 1/10/24 at 2:00 p.m. P-3: This 79-year-old patient was admitted to home care on 12/15/23 with diagnoses of diseases of the spinal cord, hypertension, and diabetes mellitus. During record review on 1/9/24, it was noted that the start of care assessment dated 12/15/23 and completed by the physical therapist, stated issues found during review, while the patient medication record stated there are no discrepancies or interactions. A medication interactions report was generated through the electronic medical record (EMR) software that indicated duplicate therapies between trazodone, citalopram, duloxetine, and bupropion, between aspirin and Plavix, amlodipine and lisinopril, and citalopram and duloxetine. There was no evidence that a RN reviewed the medications or that the physician was notified of the duplicate therapies. This finding was reviewed and acknowledged by Staff-A during an interview on 1/10/24 at 2:00 p.m.”

“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 the plan of care included all pertinent diagnoses, medications, functional limitations, patient-specific interventions, and measurable outcomes and goals for 7 of 7 (P- 1, 2, 3, 4, 5, 6, 7) records reviewed, resulting in patients not receiving care specific to their individual needs and the potential for poor patient outcomes for these patients. Findings include: P-4: This patient was admitted to home care on 12/14/23 with diagnoses of status post right iliac thrombectomy (surgery to remove a blood clot) with femoral below the knee bypass (creates a new route for blood flow to lower leg). During record review on 1/9/24, it was noted that the 12/14/23 plan of care (POC) failed to include the following: medications, functional limitations, measurable outcomes and goals, and types of services and equipment required. The 12/10/23 discharge instructions from the Veteran Affairs (VA) hospital lists 3 new medications and 12 medications to continue taking post discharge. The POC failed to list any medications. The VA discharge instructions state, no heavy lifting greater than 5 lbs. for 4 to 6 weeks. The POC failed to include this functional limitation. The comprehensive assessment conducted by the nurse on 12/14/23, notes orders for disciplines and treatments includes nursing and a physical therapy evaluation. The POC failed to note the PT evaluation under orders and treatments. The comprehensive assessment also notes under skilled interventions that the patient’s wound vac is to be set at 125 continuous suction. The POC fails to note this skilled intervention. The POC includes the following skilled nursing goals: patient will be independent with insulin administration by end of episode and patient will verbalize understanding of proper use of pain medications by end of episode. The goals were not stated in measurable terms that would enable staff to perform an objective evaluation of the patient’s progress toward his goals. The findings were reviewed with and acknowledged by the Administrator (Staff-A) during an interview on 1/9/24 at 2:20 p.m. P-5: This 84-year-old patient was admitted to home care on 12/13/23 with a diagnosis of left shoulder pain after a recent fall on the sidewalk. During record review on 1/8/24, it was noted that the12/13/23 POC failed to include primary and secondary diagnoses. This area was blank on the POC. P-6: This 78-year-old patient was admitted to home care on 1/3/24 with diagnoses of multiple sclerosis (MS) and migraine headaches. During record review on 1/8/24, it was noted that the 1/3/24 POC ordered the physician to be notified when fasting blood sugar is greater than 150 or less than 50 and when random blood sugar is greater than 250 or less than 50. The POC does not list diabetes as a diagnosis and no diabetic medications are listed on the POC. During a joint survey home visit with the registered nurse on 1/10/24 at 10:00 a.m., the patient was queried if she was diabetic, checked her blood sugars, or took any diabetic medications. The patient replied that she is not diabetic. The POC included interventions that were not specific to the patient’s needs. P-7: This patient was admitted to home care on 6/2/23 with a diagnosis of post operative surgical wound infection. During record review on 1/8/24, it was noted that the 6/2/23 POC included skilled nursing goals that were not stated in measurable terms that would enable staff to perform an objective evaluation of the patient’s progress toward his goals. One goal stated the patient will maintain daily weight diet compliance during the episode. The patient is on a no added salt nutritional requirement. There was no indication of the daily weight compliance goal to be achieved. Another goal stated the patient will achieve pain level less than (blank). There was no stated pain goal. The next goal stated the patient will verbalize analgesia (pain free) per patient comfort level. There was no indication of the comfort level the patient wished to achieve. P-1: This 79-year-old patient was admitted to home care on 1/27/23, with diagnoses of multiple sclerosis, chronic pain, and sciatica. During record review on 1/8/24, it was noted that the plan of care ordered skilled nursing to monitor blood sugar, when patient does not have a history of diabetes. There was no evidence of blood sugar monitoring for any of the five skilled nursing visits. This finding was reviewed and acknowledged by the administrator (Staff-A) during an interview on 1/10/24 at 11:00 a.m. P-2: This 79-year-old patient was admitted to home care on 12/27/23, with diagnoses of chronic kidney disease, chronic obstructive pulmonary disease (COPD), and diabetes. During record review on 1/8/24, it was noted that the plan of care failed to include measurable nursing goals that are individualized to address patient needs. The plan of care contained the following goals: “patient will verbalize understanding of proper use of pain medication” and another stated, “wounds will decrease in size by 100.” There was no evidence of how these could be objectively measured to determine progress toward meeting the goals. This finding was reviewed and acknowledged by Staff-A during an interview on 1/10/24 at 2:00 p.m. Agency policy III.6 – Physician’s Plan of Treatment/Change Orders (no date) states, “the plan of treatment shall be developed within five days of the assessment.” Physical therapy (PT) evaluated this patient on 12/28/23. As of 1/8/24 at 3:54 p.m., the status of the PT evaluation was “not started” and there were no PT interventions or goals to review. Staff-A stated the PT had completed the charting on 1/9/24, 13 days after initial assessment, during an interview on 1/10/24 at 2:00 p.m. P-3: This 79-year-old patient was admitted to home care on 12/15/23 with diagnoses of diseases of the spinal cord, hypertension, and diabetes mellitus. During record review on 1/9/24, it was noted that the plan of care failed to include bleeding precautions when the patient was on Plavix, a blood thinner or anti-platelet that can cause bleeding. This finding was reviewed and acknowledged by Staff-A during an interview on 1/10/24 at 2:00 p.m.”

“High risk, high volume, or problem-prone area CFR(s): 484.65(c)(1)(i) (i) Focus on high risk, high volume, or problem-prone areas; This Element is not met as evidenced by: Based on record review and interview, the agency failed to implement and evaluate data driven high risk, high volume, or problem prone areas for Quality Assessment and Performance Improvement activities, resulting in the potential for poor quality outcomes for the 51 patients admitted to the agency in the past 12 months. Findings include: On 1/11/24, the agency provided for review, a binder titled QAPI (Quality Assessment and Performance Improvement). Quarterly minutes were reviewed from 4/1/23, 7/1/23, 10/1/23, and 1/2/24. QAPI initiatives included improvement of shortness of breath, acute care hospitalization, improvement of muscle movement, improvement in management of oral medication, and completing QAPI’s as required. There was no data or evidence as to how these initiatives were determined to be high risk, high volume, or problem prone areas for the agency. The administrator (Staff-A) stated initiatives are generated through the electronic medical record software, Smart QAPI, during an interview on 1/11/24 at 11:40 a.m.”

“Incidence, prevalence, severity of problems CFR(s): 484.65(c)(1)(ii) (ii) Consider incidence, prevalence, and severity of problems in those areas; and This Element is not met as evidenced by: Based on record review and interview, the agency failed to evaluate the incidence, prevalence, and severity of problems identified for the Quality Assessment and Performance Improvement activities, resulting in the potential for poor quality outcomes for the 51 patients admitted to the agency in the past 12 months. Findings include: On 1/11/24, the agency provided for review, a binder titled QAPI (Quality Assessment and Performance Improvement). Quarterly minutes were reviewed from 4/1/23, 7/1/23, 10/1/23, and 1/2/24. QAPI initiatives included improvement of shortness of breath, acute care hospitalization, improvement of muscle movement, improvement in management of oral medication, and completing QAPI’s as required. There was no data or evidence to evaluate the incidence, prevalence, and severity of problems identified by the agency. This finding was reviewed and acknowledged by the administrator (Staff-A) during an interview on 1/11/24 at 11:40 a.m.”

“Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure skilled professionals performed assessments of the patient’s health status and needs in 1 of 7 (P-4) records reviewed with multiple disciplines ordered, resulting in the potential for unidentified health concerns, decline in physical functioning, and poor patient outcomes for this patient. Findings include: P-4: This patient was admitted to home care on 12/14/23 with diagnoses of status post right iliac thrombectomy (surgery to remove a blood clot) with femoral below the knee bypass (creates a new route for blood flow to lower leg). During record review on 1/9/24, it was noted that the 12/1/23 referral from the hospital orders the physical therapist (PT) to provide 9 visits. The comprehensive assessment completed by the nurse on 12/14/23 notes that the patient needs a PT evaluation. The PT conducted an evaluation of this patient 8 days later, on 12/22/23. There was no documentation to indicate the patient had delayed the PT evaluation or that the physician was notified of the delay in PT services. During the entrance interview with the Administrator (Staff-A) on 1/8/24 at 10:08 a.m., the administrator was queried regarding the agency’s policy or practice regarding other disciplines conducting patient evaluations. Staff-A replied the other disciplines are expected to conduct an evaluation within 24-48 hours after the start of care.”

“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 skilled professionals provided services as ordered by the physician in the plan of care for 4 of 7 (P- 1, 3, 4, 7) records reviewed, resulting in a poor outcome for one patient (P-4). Findings include: P-1: This 79-year-old patient was admitted to home care on 1/27/23, with diagnoses of multiple sclerosis, chronic pain, and sciatica. During record review on 1/8/24, it was noted that physical therapy (PT) was ordered twice per week for two weeks, then once a week for five weeks. PT evaluated the patient on 1/31/23 and discharged the patient from the agency on 3/21/23. There was no record of a visit during week 8 (3/13/23-3/19/23). There was no documented evidence to indicate the patient had declined this visit and no evidence the physician was informed that visit had not been provided as ordered. This finding was reviewed and acknowledged by the administrator (Staff-A) during an interview on 1/10/24 at 11:00 a.m. P-3: This 79-year-old patient was admitted to home care on 12/15/23 with diagnoses of diseases of the spinal cord, hypertension, and diabetes mellitus. The plan of care ordered physical therapy (PT) once a week for one week, twice per week for four weeks, and once a week for 3 weeks. During record review on 1/9/24, it was noted that PT failed to provide a second visit in week two. There was no documented evidence to indicate the patient had declined this visit and no evidence the physician was informed that visit had not been provided as ordered. This finding was reviewed and acknowledged by the administrator (Staff-A) during an interview on 1/10/24 at 2:00 p.m. P-4: This patient was admitted to home care on 12/14/23 with diagnoses of status post right iliac thrombectomy with femoral below the knee bypass. The patient was released from the hospital on 12/10/23 with a right groin wound with a wound vac. The dressing was to be changed 3 times weekly. During record review on 1/9/24, it was noted that the 12/14/23 plan of care ordered the skilled nurse to provide 3 visits each week for 4 weeks. In week 2, the registered nurse (Staff-B) provided visits on 12/18/23 and 12/21/23. There was no 3rd visit in week two as ordered by the physician in the plan of care. There was no documentation to indicate the patient had declined the visit and no evidence that the physician was informed that the third visit had not been provided and that the nurse had not provided wound care as ordered. The next documented visit by the nurse (Staff-B) was on 12/26/23. The visit note states the wound is malodorous, patient instructed to go to the emergency room at the Veteran Affairs Hospital. P-7: This patient was admitted to home care on 6/2/23 with a diagnosis of post operative surgical wound infection. During record review on 1/8/24, it was noted that the 6/2/23 plan of care ordered the skilled nurse to provide one visit the first week and then two visits each week for three weeks. In week three, the registered nurse (Staff-B) documented a visit on 6/12/23. There was no second visit in week three as ordered by the physician. There is a missed visit note signed by Staff-B which states the reason is due to cancellation of care and that the physician was not notified. The note does not indicate who cancelled the care: patient, caregiver, or the nurse. The finding was reviewed with the Administrator (Staff-A) during an interview on 1/9/24 at 2:20 p.m. Staff-A explained that staff are not to write a missed visit note until Saturday, the last day of the week. Staff are supposed to make attempts to visit the patient each day through Saturday and they should also document their efforts to visit the patient.”

“Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure skilled professionals prepared clinical notes for 1 of 7 (P-5) records reviewed, resulting in a lack of information regarding the health status of this patient. Findings include: P-5: This 84-year-old patient was admitted to home care on 12/13/23 with a diagnosis of left shoulder pain after a recent fall on the sidewalk. The 12/13/23 plan of care orders weekly physical therapy (PT) services for this patient. During record review on 1/10/24, it was noted that there were no physical therapy clinical notes since 12/29/23 for review. It was unclear if PT services were provided in week four or not documented. During the entrance interview with the Administrator (Staff-A) on 1/8/24 at 10:08 a.m., Staff-A explained that visit notes are completed within 1-3 days. The agency’s policy titled, Clinical Record Contents and Maintenance (no date) states, clinical notes should be written the day of the service delivery, signed, and incorporated into the record at least weekly. There were no physical therapy notes available for review for week four.”

“Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the skilled nurse communicated with the physician regarding wound vac dressing coming off for 1 of 1 (P-4) records reviewed with patients with a wound vac, resulting in a poor outcome for this patient. Findings include: P-4: This patient was admitted to home care on 12/14/23 with diagnoses of status post right iliac thrombectomy (surgery to remove a blood clot) with femoral below the knee bypass (creates a new route for blood flow to lower leg). The patient was hospitalized at the Veteran Affairs hospital from 11/23/23 to 12/10/23. The patient was discharged from the hospital on 12/10/23 and returned home with a wound vac to the right groin. The record was reviewed on 1/9/24. The registered nurse (Staff-B) documented a communication note dated 12/18/23 which states a call was received from the patient that the dressing from the vac came off. The daughter was instructed to remove the vac dressing and apply a 4X4 and tape to the wound. Patient has an appointment at the Veteran Affairs (VA) hospital on 12/19/23. On 12/18/23 Staff-B documented a communication note that a message was left for the nurse practitioner regarding the need for white foam for wound vac. There was no documentation to indicate Staff-B informed the physician that the wound vac dressing had come off and was now covered with a 4x4. There was no documentation to indicate Staff-B made a prn (as needed) visit on 12/18/23, 12/19/23, or 12/20/23 to assess and redress the wound. There was no evidence Staff-B communicated with the patient or doctor to see if the patient had gone to the VA hospital on 12/19/23 and had the wound redressed and attached to the wound vac. Staff-B documented a visit on 12/21/23 and then a visit on 12/26/23 and noted the wound vac had lost pressure and the wound was malodorous. The patient was instructed to go the emergency room at the VA hospital. The above findings were reviewed with the Administrator (Staff-A) during an interview on 1/9/24 at 2:20 p.m. Staff-A explained that the nurse was not expected to make a patient visit regarding the phone call on 12/18/23 (wound vac dressing came off). The nurse is expected to inform the doctor of the wound status and vac dressing off. There was no evidence Staff-B informed the doctor of the patient’s wound status and that the vac dressing was off. The communication note on 12/18/23 states Staff-B left a message for the nurse practitioner regarding the need for white foam for wound vac.”

“Ensures qualified pre-designated person CFR(s): 484.105(b)(2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section. This Element is not met as evidenced by: Based on record review and interview, the agency failed to have a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, to assume the same responsibilities and obligations as the administrator, in the administrator’s absence. Findings include: During the entrance interview on 1/8/24 at 10:00 a.m., the administrator (Staff-A) was asked to name the alternate administrator, and responded the agency did not have an alternate. Agency Policy II.4 – Designation of Administrator, Clinical Manager & Alternates (9/2019), listed a physical therapist (PT) as alternate administrator. Staff-A stated the PT “left a long time ago” and acknowledged that an alternate was not named or authorized by the governing body in an interview on 1/11/24 at 11:40 a.m.”

“Must have a written agreement CFR(s): 484.105(e)(2)(i-iv) An HHA must have a written agreement with another agency, with an organization, or with an individual when that entity or individual furnishes services under arrangement to the HHA’s patients. The HHA must maintain overall responsibility for the services provided under arrangement, as well as the manner in which they are furnished. The agency, organization, or individual providing services under arrangement may not have been: (i) Denied Medicare or Medicaid enrollment; (ii) Been excluded or terminated from any federal health care program or Medicaid; (iii) Had its Medicare or Medicaid billing privileges revoked; or (iv) Been debarred from participating in any government program. This Element is not met as evidenced by: Based on record review and interview, the agency failed to have completed written agreements with 3 of 4 (Staff-C, Staff-D, Staff-E) independent contractors furnishing services under arrangement to agency patients, resulting in a lack of overall responsibility by the agency for the services provided under arrangement. Findings include: The staff roster provided by the Administrator (Staff-A) indicates that 4 individuals were independent contractors (1099) providing patient services. During record review on 1/10/24, it was noted that 3 of 4 written agreements were incomplete. Staff-C registered nurse, date of hire 12/19/23 Staff-D physical therapist, date of hire 8/24/23 Staff-E physical therapist, date of hire 11/21/23 The written agreements for the 3 staff were blank in the following areas of the agreement: the name of the individual (business associate), the type of services provided, terms of compensation, and representative of University Home Care signature, printed name, title, and date. The written agreements with Staff-C, Staff-D, and Staff-E are incomplete and not legally enforceable. The findings were reviewed with and acknowledged by Staff-A during an interview on 1/11/24 at 11:20 a.m.”

“Required items in clinical record CFR(s): 484.110(a)(1) The patient’s current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record contained completed assessments and visit notes for 2 of 7 (P-2, 3) records reviewed, resulting in the potential for poor patient outcomes and a lack of information for all agency staff caring for the patient. Findings include: Agency policy III.6 – Physician’s Plan of Treatment/Change Orders (no date) states, “the plan of treatment shall be developed within five days of the assessment.” Agency policy III.13 – Clinical Record Contents and Maintenance (no date) states, “all medical record entries should be made as soon as possible after the care is provided.” Entrance interview with Administrator (Staff-A) on 1/8/24 at 10:00 a.m.: Staff-A stated visit notes are to be completed within 24-48 hours. P-2: This 79-year-old patient was admitted to home care on 12/27/23, with diagnoses of chronic kidney disease, chronic obstructive pulmonary disease (COPD), and diabetes. During record review on 1/8/24, it was noted that the physical therapy evaluation on 12/28/23 and visit notes for 1/3/24 and 1/5/24 were “not started” as of 1/8/24 at 3:54 p.m. During an interview with the physical therapist (Staff-E) on 1/10/24 at 10:00 a.m., the therapist stated he completes visit notes within 48 hours. P-3: This 79-year-old patient was admitted to home care on 12/15/23 with diagnoses of diseases of the spinal cord, hypertension, and diabetes mellitus. During record review on 1/9/24, it was noted that the physical therapy (Staff-E) visit notes from 12/19/23, 12/26/23, 12/28/23, 1/3/24, and 1/5/24 were “not started” as of 1/9/24 at 11:18 a.m. These findings were reviewed and acknowledged by the administrator (Staff-A) during an interview on 1/10/24 at 2:00 p.m.”

“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 review and interview, the agency failed to ensure a detailed discharge summary was sent to the physician within 5 business days of discharge for 1 of 2 (P-1) discharge records reviewed, resulting in a lack of information to ensure continuity of care. Findings include: P-1: This 79-year-old patient was admitted to home care on 1/27/23, with diagnoses of multiple sclerosis, chronic pain, and sciatica. During record review on 1/8/24, it was noted that the patient was discharged from agency services on 2/23/23. The discharge summary report had a faxed date of 4/11/23, 21 days (15 business days) after discharge. This finding was reviewed and acknowledged by the administrator (Staff-A) during an interview on 1/10/24 at 11:00 a.m.”