Every finding on record at Family Care Choice & Services, Inc

A Medicare emergency preparedness survey was conducted by the Michigan Department of Licensing and Regulatory Affairs from 9/19/22-9/22/22 at: Family Care Choice and Services, Inc. 23800 West 10 Mile Rd. suite 108 Southfield, MI 48033 At the time of the survey, the agency operated no branches or extension sites. COVID-19 vaccination requirements were reviewed during this survey. Clinical records reviewed for this survey included 7 records with no home visits. The agency had no active patients. The following Condition level deficiencies were identified at: 42 CFR § 484.60 Care Planning, coordination, quality of care. 42 CFR § 484.65 Quality assessment/performance improvement. 42 CFR § 484.70 Infection prevention and control. 42 CFR § 484.102 Emergency preparedness. 42 CFR § 484.105 Organization and Administration of Services. As a result of the Condition level noncompliance, the agency is prohibited for 2 years from offering a home health aide training and competency evaluation or a competency evaluation program as specified in 42 CFR §484.80 (f)(3).

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, §485.625, §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 document review and interview, the Agency (HHA) failed to develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually (See E0004); failed to incorporate the use of volunteers or other staffing strategies to address surge needs during an emergency (See E0024); Based on interview, the agency failed to develop and maintain an Emergency Preparedness communication plan and ensure the communication plan was reviewed and updated at least every two years (See E0029; failed to address primary and alternate means for communication with the HHA's staff, Federal, State, tribal, regional, and local emergency management agencies (See E0032); and failed to conduct exercises to test the emergency plan at least every two years (See E0039). The cumulative effect of these systemic problems could potentially affect all occupants of the facility in the event staff is not properly prepared for an emergency for the condition of participation of 42 CFR§484.102, Emergency Preparedness.

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop 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: (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 all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [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. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop, review, and update the EP plan at least every two years. Resulting in no guidance for agency actions in the event of an actual emergency or disaster. This deficient practice could affect the health and safety of all agency patients in the event of a natural, man-made, or facility-based emergency. Findings include: On 9/21/22 at 4:00 p.m., the administrator (Adm#1) was asked to provide documentation of the agency's emergency preparedness (EP) program. Adm#1 said she has not done any EP activities since 2019. No documentation of the agency's EP plan, except policies, for 2020, 2021 or 2022 were available for review. There was no documented evidence that the agency had developed an emergency preparedness plan. All agency patients could be impacted by the agency's failure to develop an emergency preparedness plan. During an interview on 9/22/22 at 2:00 p.m., the Administrator (Adm#1) acknowledged she has to review and update the EP plan from 2019.

Policies/Procedures-Volunteers and Staffing CFR(s): 484.102(b)(5) §403.748(b)(6), §416.54(b)(5), §418.113(b)(4), §441.184(b)(6), §460.84(b)(7), §482.15(b)(6), §483.73(b)(6), §483.475(b)(6), §484.102(b)(5), §485.68(b)(4), §485.625(b)(6), §485.727(b)(4), §485.920(b)(5), §491.12(b)(4), §494.62(b)(5). [(b) Policies and procedures. The [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 [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] (6) [or (4), (5), or (7) as noted above] The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. *[For RNHCIs at §403.748(b):] Policies and procedures. (6) The use of volunteers in an emergency and other emergency staffing strategies to address surge needs during an emergency. *[For Hospice at §418.113(b):] Policies and procedures. (4) The use of hospice employees in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined that the agency's (HHA) Emergency Preparedness (EP) plan, policies and procedures, failed to address the use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency, resulting in the agency's inability to respond effectively in the event of an emergency. Findings include: On 9/21/22 at 4:00 p.m., the administrator (Adm#1) was asked to provide documentation of the agency's emergency preparedness (EP) program. Adm#1 said she has not done any EP activities since 2019. No documentation of the agency's EP plan, except policies, for 2020, 2021 or 2022 were available for review. There was no documented evidence that the agency had developed an emergency preparedness plan. All agency patients could be impacted by the agency's failure to develop an emergency preparedness plan. During an interview on 9/22/22 at 4:00 p.m., the Administrator (Adm#1) acknowledged she has to review and update the EP plan from 2019.

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), §485.625(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 interview, the agency failed to develop and maintain an Emergency Preparedness communication plan and ensure the communication plan was reviewed and updated at least every two years. This deficient practice could affect the health and safety of all agency patients in the event of a natural, man-made, or facility-based emergency. Findings include: On 9/21/22 at 4:00 p.m., the administrator (Adm#1) was asked to provide documentation of the agency's emergency preparedness (EP) program. Adm#1 said she has not done any EP activities since 2019. No documentation of the agency's EP plan, except policies, for 2020, 2021 or 2022 were available for review. There was no documented evidence that the agency had developed an emergency preparedness plan. All agency patients could be impacted by the agency's failure to develop an emergency preparedness plan. During an interview on 9/22/22 at 4:00 p.m., the Administrator (Adm#1) acknowledged she has to review and update the EP plan from 2019.

Primary/Alternate Means for Communication CFR(s): 484.102(c)(3) §403.748(c)(3), §416.54(c)(3), §418.113(c)(3), §441.184(c)(3), §460.84(c)(3), §482.15(c)(3), §483.73(c)(3), §483.475(c)(3), §484.102(c)(3), §485.68(c)(3), §485.625(c)(3), §485.727(c)(3), §485.920(c)(3), §486.360(c)(3), §491.12(c)(3), §494.62(c)(3). [(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]. The communication plan must include all of the following: (3) Primary and alternate means for communicating with the following: (i) [Facility] staff. (ii) Federal, State, tribal, regional, and local emergency management agencies. *[For ICF/IIDs at §483.475(c):] (3) Primary and alternate means for communicating with the ICF/IID's staff, Federal, State, tribal, regional, and local emergency management agencies. This STANDARD is not met as evidenced by: Based on record review and interview, the agency (HHA) failed to develop and maintain an emergency preparedness communication plan that included an alternate means for communicating with agency staff, Federal, State, tribal, regional, and local emergency preparedness officials, resulting in the lack of essential information in the event of an actual emergency. Findings include On 9/21/22 at 4:00 p.m., the administrator (Adm#1) was asked to provide documentation of the agency's emergency preparedness (EP) program. Adm#1 said she has not done any EP activities since 2019. No documentation of the agency's EP plan, except policies, for 2020, 2021 or 2022 were available for review. There was no documented evidence that the agency had developed an emergency preparedness plan. All agency patients could be impacted by the agency's failure to develop an emergency preparedness plan. During an interview on 9/22/22 at 4:00 p.m., the Administrator (Adm#1) acknowledged she has to review and update the EP plan from 2019.

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), §485.625(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, 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 (HHA), failed to conduct exercises to test, at least every two years, the emergency plan or provide documentation of an actual event that would qualify as a test of the emergency plan; failed to conduct an additional full-scale exercise or a table-top exercise; and failed to analyze the clinic's response to and maintain documentation of all drills, tabletop exercises, emergency events and revise the emergency plan as needed. This deficient practice could affect the health and safety of all agency patients in the event of a facility emergency or disaster. Findings include: On 9/21/22 at 4:00 p.m., the administrator (Adm#1) was asked to provide documentation of the agency's emergency preparedness (EP) program. Adm#1 said she has not done any EP activities since 2019. No documentation of the agency's EP plan, except policies, for 2020, 2021 or 2022 were available for review. There was no documented evidence that the agency had developed an emergency preparedness plan. All agency patients could be impacted by the agency's failure to develop an emergency preparedness plan. During an interview on 9/22/22 at 4:00 p.m., the Administrator (Adm#1) acknowledged she has to review and update the EP plan from 2019.

A Medicare recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs from 9/19/22-9/22/22 at: Family Care Choice and Services, Inc. 23800 West 10 Mile Rd. suite 108 Southfield, MI 48033 At the time of the survey, the agency operated no branches or extension sites. COVID-19 vaccination requirements were reviewed during this survey. Clinical records reviewed for this survey included 7 records with no home visits. The agency had no active patients. The following Condition level deficiencies were identified at: 42 CFR § 484.60 Care Planning, coordination, quality of care. 42 CFR § 484.65 Quality assessment/performance improvement. 42 CFR § 484.70 Infection prevention and control. 42 CFR § 484.102 Emergency preparedness. 42 CFR § 484.105 Organization and Administration of Services. As a result of the Condition level noncompliance, the agency is prohibited for 2 years from offering a home health aide training and competency evaluation or a competency evaluation program as specified in 42 CFR §484.80 (f)(3).

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, it was determined that the Agency (HHA) failed to ensure the comprehensive assessment included a review of all medications to determine any adverse effects; failed to document the findings of the drug regime review as required; failed to have a skilled nurse review the medications; and failed to ensure the physician was notified of potential drug interactions in 3 records, from a total of 7 sampled records reviewed (MR's # 1, 2 and 3), resulting in the potential for harmful medication effects for all patients serviced by this Agency. Findings include: **Agency policy: Medication reconciliation 8.15.1, revised March 2018 states, "The agency will reconcile the patient's medications at time of addmission.....any concerns or discrepencies will be reconciled by a registered nurse with the patient's physician." MR#1: The start of care (SOC) was dated 4/7/21, with diagnoses that included hypertension (HTN), rotator cuff tear, and polyosteoarthritis. During record review on 9/19/22, it was discovered that no medication reconciliation was documented in the record. Physical therapy (PT#1) did the SOC comprehensive assessment and indicated "No issues found" under M2001. PT#1 signed the medication profile dated 4/7/21. There was no documentation in the record that a skilled nurse reviewed the medications. A review on Drugs.com found 8 moderate, 6 minor, and 5 food interactions. There was no documentation that a medication reconciliation was sent to the physician. The above policy states that all discrepencies will be reviewed with the physician. MR#2: The SOC was dated 3/24/21, with diagnoses that included hypertension (HTN), osteoarthritis of bilateral knees, hyperlipidemia, and falls. During record review on 9/20/22, it was discovered that no medication reconciliation was documented in the record. Physical therapy (PT#2) did the SOC comprehensive assessment and indicated "No issues found" under M2001. PT#2 signed the medication profile dated 3/24/21. There was no documentation in the record that a skilled nurse reviewed the medications. A review on Drugs.com found 4 moderate, 4 minor, and 3 food interactions. There was no documentation that a medication reconciliation was sent to the physician. The above policy states that all discrepencies will be reviewed with the physician. MR#3: The SOC was dated 1/29/20, with diagnoses that included dementia, encephalopathy, and coronary artery disease. During record review on 9/20/22, it was discovered that no medication reconciliation was documented in the record. Physical therapy (PT#3) did the SOC comprehensive assessment and indicated "No issues found" under M2001. PT#3 signed the medication profile, undated. There was no documentation in the record that a skilled nurse reviewed the medications. A review on Drugs.com found 2 major, 23 moderate, 3 minor, 6 food interactions, and 3 duplications. There was no documentation that a medication reconciliation was sent to the physician. The above policy states that all discrepencies will be reviewed with the physician. During an interview on 9/22/22 at 2:00 p.m., the Administrator (Adm#1) acknowledged the above findings.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care included safety precautions for 3 of 7 records, (MR#s 2, 3, 6), failed to ensure visits were provided as ordered for 2 of 7 records, (MR#s 1, 5), (See G572), failed to provide services in 1 of 1 record (MR#6), where home health aide (HHa) services were ordered, (See G578); failed to obtain an order for services provided for 1 of 3 occupational therapy records (MR# 3), (See G580); and failed to communicate with the physician of services ordered not being provided for 1 of 7 records (MR#6), (See G590). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care for the condition of participation of 42 CFR 484.60: Care Planning, Coordination of Services, and Quality of Care.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the Home Health Agency (HHA) failed to ensure orders on the plan of care (POC) were followed for 2 records (MR# 1,5), failed to document a POC/485 in the patient record for 2 records (MR# 2,3), failed to ensure safety precautions were included on the POC for 3 records (MR# 2, 3, 6), and failed to ensure the POC was signed for 5 records (MR# 1, 2, 3, 4, 5), from a total of 7 records reviewed, resulting in the potential for a plan of care not meeting the patient's needs. Findings include: **Agency policy: Plan of Care - CMS #485 and Physician Orders-9.10.1, revised March 2019 stated, "Skilled nursing and other home health services will be in accordance with a plan of care....each plan of care must be signed and dated by the physician. The individualized plan of care must include the following: Safety measures to protect against injury." MR#1: The start of care (SOC) was dated 3/24/21, with diagnoses that included hypertension (HTN), rotator cuff tear, and polyosteoarthritis. During record review on 9/19/22, it was discovered that the physical therapist (PT#1) missed a visit during week 4. There was no note or documentation in the record explaining why the visit was missed. It was also discovered that the POC dated 4/7/21, was not signed by the physician as of 9/22/22. MR#2: The SOC was dated 4/25/19, with diagnoses that included hypertension (HTN), osteoarthritis of bilateral knees, hyperlipidemia, and falls. During record review on 9/20/22, it was discovered that the physical therapist's POC did not have fall precautions documented. It was also discovered that no POC/485 was documented in the record. MR#3: The SOC was dated 1/29/20, with diagnoses that included dementia, encephalopathy, and coronary artery disease. During record review on 9/20/22, it was discovered that the physical therapist's and the occupational therapist's POC did not have bleeding/anticoagulant precautions documented with the patient on Eliquis. It was also discovered that no POC/485 was documented in the record. MR#5: The SOC was dated 9/5/20, with diagnoses that included hypertension (HTN), heart disease, diabetes and abcess. During record review on 9/21/22, it was discovered that the skilled nurse (RN#1) missed a visit during week 4. There was no note or documentation in the record explaining why the visit was missed. MR#6: The SOC was dated 3/5/20, with diagnoses that included heart failure, atrial fibrillation, and diabetes. During record review on 9/21/22, it was discovered that the physical therapist's POC did not have bleeding/anticoagulant precautions documented with the patient on Apixaban. During an interview on 9/22/22 at 2:00 p.m., the Administrator (Adm#1) acknowledged the above findings.

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, it was determined that the home health agency failed to ensure the physician orders were followed in 1 of 1 records (MR# 6) where home health aide (HHa) and physical therapy (PT) services were ordered, from a total of 7 records reviewed, resulting in the potential for unmet patient care needs. Findings include: MR#6: The SOC was dated 3/5/20, with diagnoses that included heart failure, atrial fibrillation, and diabetes. During record review on 9/21/22, it was discovered that the plan of care (POC) dated 3/5/20, had HHa and PT services ordered. There was no documentation in the record that HHa and PT services were ever provided to the patient. There was no documentation in the record explaining why the services were not provided or if the patient declined services. During an interview on 9/22/22 at 2:00 p.m., the Administrator (Adm#1) acknowledged the above findings.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined that the agency failed to ensure treatments were provided in accordance with a physician's order in 1 of 3 records reviewed (MR # 3) in which occupational therapy (OT) services were provided, from a total of 7 records reviewed, resulting in the potential for the patient to receive inappropriate treatments. Findings include: MR#3: The SOC was dated 1/29/20, with diagnoses that included dementia, encephalopathy, and coronary artery disease. During record review on 9/20/22, it was discovered that the patient's plan of care (POC) ordered the patient to receive physical therapy (PT) services 2 times a week for 5 weeks. Further review of the record showed OT services were provided 1 time a week for 1 week, then 2 times a week for 2 weeks. No evidence was found in the clinical record that an order was received or that the physician was made aware that OT services were provided to the patient. During an interview on 9/22/22 at 2:00 p.m., the Administrator (Adm#1) acknowledged the above findings.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined that the agency failed to inform the physician that ordered services were not provided for 1 of 7 records reviewed (MR #6) in which home health aide (HHa) and physical therapy (PT) services were ordered, from a total of 7 records reviewed, resulting in the potential for unmet patient care needs. Findings include: MR#6: The SOC was dated 3/5/20, with diagnoses that included heart failure, atrial fibrillation, and diabetes. During record review on 9/21/22, it was discovered that the plan of care (POC) dated 3/5/20, had HHa and PT services ordered. There was not documentation in the record that HHa and PT services were ever provided. There was also no communication documented in the record that the physician was notified of HHa and PT services not being provided to the patient. During an interview on 9/22/22 at 2:00 p.m., the Administrator (Adm#1) acknowledged the above findings. .

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to maintain a Quality Assessment Performance Improvement (QAPI) program to optimize patient outcomes, (See G642); failed to collect and monitor data for the QAPI program in 2020, 2021, and 2022, (See G644); failed to initiate any performance improvement activities within their QAPI program, (See G-646); failed to initiate any performance improvement activities within their QAPI program that focused on high risk, high volume or problem prone areas, (See G648); failed to track adverse patient events, analyze their causes, and implement preventative actions within their QAPI program, (See G654); failed to have at least one performance improvement project for 2020, 2021, and 2022, (See G658); failed to ensure the agency had an active and functioning QAPI program that fulfilled all the regulatory requirements of this section, that addressed priorities for improved quality of care and patient safety and was evaluated for effectiveness, (See G660). The cumulative effect of these systemic problems resulted in the agency's inability to improve patient care, health outcomes, patient safety, and the agency's overall care performance resulting in the agency not providing quality health care. Findings include:

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to provide evidence of its efforts to measure, track and analyze its quality indicators for 2020, 2021, and 2022, in order to assess processes of care and services, resulting in the inability to determine the scope of services provided and the potential for unmet care needs. Findings include: On 9/21/22 at 4:00 p.m., the administrator (Adm#1) was asked to provide documentation of the agency's Quality Assessment/Performance Improvement program. Adm#1 said she has not done any QAPI activities since 2019. No documentation of the agency's QAPI program, except policies, for 2020, 2021 or 2022 were available for review. There was no documented evidence that the agency had measured, tracked and analyzed any quality indicators in the QAPI program for 2020, 2021, or 2022. All agency patients could be impacted by the agency's failure to measure, track and analyze quality indicators. During an interview on 9/22/22 at 2:00 p.m., the Administrator (Adm#1) acknowledged she needs to resume and maintain the required QAPI activities.

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to collect and monitor data for the Quality Assessment and Performance Improvement (QAPI) program, to ensure the effectiveness and safety of services and quality of care to the patients and to identify opportunities for improvement, resulting in the potential for ineffective, unsafe and unmet care needs. Findings include: On 9/21/22 at 4:00 p.m., the administrator (Adm#1) was asked to provide documentation of the agency's Quality Assessment/Performance Improvement program. Adm#1 said she has not done any QAPI activities since 2019. No documentation of the agency's QAPI program, except policies, for 2020, 2021 or 2022 were available for review. There was no documented evidence that the agency had collected and monitored data, in the QAPI program for 2020, 2021, or 2022. All agency patients could be impacted by the agency's failure to collect and monitor data. During an interview on 9/22/22 at 2:00 p.m., the Administrator (Adm#1) acknowledged she needs to resume and maintain the required QAPI activities.

Program activities CFR(s): 484.65(c) Standard: Program activities. The HHA's performance improvement activities must-- This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the Agency (HHA) failed to initiate any performance improvement activities within their Quality Assessment Performance Improvement (QAPI) program, resulting in the potential for the rendering of substandard care and unmet care needs. Findings include: On 9/21/22 at 4:00 p.m., the administrator (Adm#1) was asked to provide documentation of the agency's Quality Assessment/Performance Improvement program. Adm#1 said she has not done any QAPI activities since 2019. No documentation of the agency's QAPI program, except policies, for 2020, 2021 or 2022 were available for review. There was no documented evidence the agency initiated any performance improvement activities in the QAPI program for 2020, 2021, or 2022. All agency patients could be impacted by the agency's failure to initiate any performance improvement activities. During an interview on 9/22/22 at 2:00 p.m., the Administrator (Adm#1) acknowledged she needs to resume and maintain the required QAPI activities.

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, it was determined the Agency (HHA) failed to initiate any performance improvement activities within their Quality Assessment Performance Improvement (QAPI) program that focused on high risk, high volume or problem prone areas, resulting in the potential for agency issues to go unresolved in high risk, high volume or problem prone areas that could affect all patients served by the agency. Findings include: On 9/21/22 at 4:00 p.m., the administrator (Adm#1) was asked to provide documentation of the agency's Quality Assessment/Performance Improvement program. Adm#1 said she has not done any QAPI activities since 2019. No documentation of the agency's QAPI program, except policies, for 2020, 2021 or 2022 were available for review. There was no documented evidence the agency initiated any performance improvement activities that focused on high risk, high volume or problem prone areas in the QAPI program for 2020, 2021, or 2022. All agency patients could be impacted by the agency's failure to initiate any performance improvement activities that focused on high risk, high volume or problem prone areas. During an interview on 9/22/22 at 2:00 p.m., the Administrator (Adm#1) acknowledged she needs to resume and maintain the required QAPI activities.

Track adverse patient events CFR(s): 484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the Agency (HHA) failed to track adverse patient events, analyze their causes, and implement preventative actions within their Quality Assessment Performance Improvement (QAPI) program, resulting in the potential for patient issues to go unresolved and affect all patients served by the agency. Findings include: On 9/21/22 at 4:00 p.m., the administrator (Adm#1) was asked to provide documentation of the agency's Quality Assessment/Performance Improvement program. Adm#1 said she has not done any QAPI activities since 2019. No documentation of the agency's QAPI program, except policies, for 2020, 2021 or 2022 were available for review. There was no documented evidence the agency tracked adverse patient events, analyzed their causes, or implemented preventative actions within their QAPI program for 2020, 2021, or 2022. All agency patients could be impacted by the agency's failure to track adverse patient events, analyze their causes, and implement preventative actions . During an interview on 9/22/22 at 2:00 p.m., the Administrator (Adm#1) acknowledged she needs to resume and maintain the required QAPI activities.

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, it was determined the Agency (HHA) failed to conduct any performance improvement projects within their Quality Assessment Performance Improvement (QAPI) program, resulting in the potential for patient and agency issues to go unresolved and affect all patients served by the agency. Findings include: On 9/21/22 at 4:00 p.m., the administrator (Adm#1) was asked to provide documentation of the agency's Quality Assessment/Performance Improvement program. Adm#1 said she has not done any QAPI activities since 2019. No documentation of the agency's QAPI program, except policies, for 2020, 2021 or 2022 were available for review. There was no documented evidence the agency conducted performance improvement projects within their QAPI program for 2020, 2021, or 2022. All agency patients could be impacted by the agency's failure to conduct performance improvement projects. During an interview on 9/22/22 at 2:00 p.m., the Administrator (Adm#1) acknowledged she needs to resume and maintain the required QAPI activities.

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, it was determined the Governing Body failed to ensure the agency had an active and functioning Quality Assessment and Performance Improvement (QAPI) program that fulfilled all the regulatory requirements of this section, that addressed priorities for improved quality of care and patient safety and was evaluated for effectiveness, resulting in the potential to adversely affect the quality of care to all patients receiving services. Findings include: On 9/21/22 at 4:00 p.m., the administrator (Adm#1) was asked to provide documentation of the agency's Quality Assessment/Performance Improvement program. Adm#1 said she has not done any QAPI activities since 2019. No documentation of the agency's QAPI program, except policies, for 2020, 2021 or 2022 were available for review. There was no documented evidence the agency's governing body ensured the agency had an active and functioning QAPI program for 2020, 2021, or 2022. All agency patients could be impacted by the agency's failure to hava an active and functioning Quality Assessment and Performance Improvement (QAPI) program. During an interview on 9/22/22 at 2:00 p.m., the Administrator (Adm#1) acknowledged she needs to resume and maintain the required QAPI activities.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on record review and interview, it was determined the agency failed to follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases, (See G682); and failed to maintain a functioning infection control program for 2020, 2021 and 2022 (G-684), resulting in the potential for the spread of infections to staff and patients. The cumulative effect of these systemic problems could potentially affect all agency staff and patients regarding infections and infection control.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to maintain a coordinated agency-wide program for the surveillance, identification, and prevention of COVID-19; and failed to develop a method of screening visitors and staff employed by the agency including staff who were granted clinical privileges, resulting in the potential development and spread of a contagious viral infection between agency staff and the agency's patients. Findings include: On 9/19/22 at 9:00 a.m., upon arrival to the agency, it was noted that there were no signs that instructed visitors on the protocol for entrance into the agency's suite. There was also no screening process in place for COVID-19, including the potential exposure to Covid-19, or signs and symptoms. During an interview on 9/22/22 at 2:00 p.m., the Administrator (Adm#1) acknowledged the above findings.

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 maintain an agency-wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases as a part of the agency's Quality Assessment Performance Improvement program, resulting in the potential spread of infections between patient care staff and the agency's patients. Findings include: On 9/21/22 at 4:00 p.m., the administrator (Adm#1) was asked to provide documentation of the agency's infection control program. Adm#1 said she has not done any infection control activities since 2019. No documentation of the agency's infection control program, except policies, for 2020, 2021 or 2022 were available for review. There was no documented evidence that the agency had maintained an infection control program. All agency patients could be impacted by the agency's failure to maintain an infection control program. During an interview on 9/22/22 at 2:00 p.m., the Administrator (Adm#1) acknowledged the above findings.

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, it was determined that the agency failed to communicate with the physician involved with the plan of care (POC) in 4 of 7 discharge records reviewed (MR# 1, 2, 3, 5), from a total sample of 7 records, resulting in the potential for inappropriate care and unmet care needs, Findings include: MR#1: The start of care (SOC) was dated 3/24/21, with diagnoses that included hypertension (HTN), rotator cuff tear, and polyosteoarthritis. During record review on 9/19/22, it was discovered that there was no evidence the POC dated 4/7/21, was sent to the physician for approval and signature. MR#2: The SOC was dated 4/25/19, with diagnoses that included hypertension (HTN), osteoarthritis of bilateral knees, hyperlipidemia, and falls. During record review on 9/20/22, It was discovered that no POC/485 was documented in the record. There was also no evidence a POC was sent to the physician for approval and signature. MR#3: The SOC was dated 1/29/20, with diagnoses that included dementia, encephalopathy, and coronary artery disease. During record review on 9/20/22, It was discovered that no POC/485 was documented in the record. There was also no evidence a POC was sent to the physician for approval and signature. MR#5: The SOC was dated 9/5/20, with diagnoses that included hypertension (HTN), heart disease, diabetes and abcess. During record review on 9/21/22, it was discovered that there was no evidence a POC was sent to the physician for approval and signature. During an interview on 9/22/22 at 2:00 p.m., the Administrator (Adm#1) acknowledged the above findings.

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure a governing body assumed responsibility for the operation of the agency, the provision of all home health services and its quality assessment and performance improvement program, resulting in a lack of overall leadership in the agency's provision of home health services (See G942); failed to ensure an Alternate Administrator was appointed by the governing body, (See G954); and failed to assure the development, implementation, and updates of the individualized plan of care, (See G968). The systemic effects of the above deficiencies had the potential to affect all agency patients, resulting in the provision of substandard care, patients not receiving needed services and the potential for poor patient outcomes.

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 document review and interview, it was determined the home health agency failed to have an active Governing Body that met at least annually, and assumed full legal authority and responsibility for the agency's overall management and operations, all services provided, the fiscal operations, review of the agency's budget and operations plans, and it's quality assessment and performance improvement program (QAPI), since 2019, resulting in the potential to adversely affect the quality of care to all patients receiving services. Findings include: On 9/21/22 at 4:00 p.m., the administrator (Adm#1) was asked to provide documentation of the agency's QAPI program. Adm#1 said she has not done any QAPI activities since 2019. No documentation of the agency's QAPI program, except policies, for 2020, 2021 or 2022 were available for review. There was no documented evidence that an active Governing Body met at least annually, and assumed full legal authority and responsibility for the agency's overall management and operations, all services provided, the fiscal operations, review of the agency's budget, and operations plans and it's QAPI program, since 2019. All agency patients could be impacted by the agency's failure to comply with this regulatory requirement. During an interview on 9/22/22 at 2:00 p.m., the Administrator (Adm#1) acknowledged she needs to resume and maintain the required QAPI activities.

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 an interview on 9/21/22 at 5:00 p.m., the administrator (Adm#1) was asked who the alternate administrator was. Adm#1 said she did not currently have an alternate administrator at this time due to not having any patients for the last year and a half. All agency patients could be affected by the absence of an administrator and the lack of an alternate administrator, in the administrator's absence.

Assure implementation of plan of care CFR(s): 484.105(c)(5) Assuring the development, implementation, and updates of the individualized plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined that the agency failed to assure the development, implementation, and updates of the individualized plan of care for 2 of 7 records (MR# 2, 3) from a total of 7 records reviewed, resulting in the potential for inappropriate care and unmet care needs. Findings include: MR#2: The SOC was dated 4/25/19, with diagnoses that included hypertension (HTN), osteoarthritis of bilateral knees, hyperlipidemia, and falls. During record review on 9/20/22, it was discovered that no POC/485 was documented in the record. MR#3: The SOC was dated 1/29/20, with diagnoses that included dementia, encephalopathy, and coronary artery disease. During record review on 9/20/22, it was discovered that no POC/485 was documented in the record. During an interview on 9/22/22 at 2:00 p.m., the Administrator (Adm#1) acknowledged the above findings.

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 include discharge summaries in the patient record and failed to document submission to the physician in 7 of 7 records (MR #'s 1, 2, 3, 4, 5, 6, 7) who were discharged from a total of 7 records reviewed, resulting in the potential for unidentified continuing health care concerns and unmet care needs. Findings include: MR#1: The start of care (SOC) was dated 3/24/21, with diagnoses that included hypertension (HTN), rotator cuff tear, and polyosteoarthritis. During record review on 9/19/22, it was discovered that no discharge summary was documented in the record and there was no documentation in the record that a discharge summary was sent to the physician. MR#2: The SOC was dated 4/25/19, with diagnoses that included hypertension (HTN), osteoarthritis of bilateral knees, hyperlipidemia, and falls. During record review on 9/20/22, it was discovered that no discharge summary was documented in the record and there was no documentation in the record that a discharge summary was sent to the physician. MR#3: The SOC was dated 1/29/20, with diagnoses that included dementia, encephalopathy, and coronary artery disease. During record review on 9/20/22, it was discovered that there was no documentation in the record that a discharge summary was sent to the physician. MR#4: The SOC was dated 10/9/20, with diagnoses that included chronic obstructive pulmonary disease, congestive heart failure and diabetes. During record review on 9/20/22, it was discovered that no discharge summary was documented in the record and there was no documentation in the record that a discharge summary was sent to the physician. MR#5: The SOC was dated 9/5/20, with diagnoses that included hypertension (HTN), heart disease, diabetes and abcess. During record review on 9/21/22, it was discovered that no discharge summary was documented in the record and there was no documentation in the record that a discharge summary was sent to the physician. MR#6: The SOC was dated 3/5/20, with diagnoses that included heart failure, atrial fibrillation, and diabetes. During record review on 9/21/22, it was discovered that there was no documentation in the record that a discharge summary was sent to the physician. MR#7: The SOC was dated 9/29/20, with diagnoses that included hemiplegia, hypertension, chronic kidney disease, and diabetes. During record review on 9/21/22, it was discovered that there was no documentation in the record that a discharge summary was sent to the physician. During an interview on 9/22/22 at 2:00 p.m., the Administrator (Adm#1) acknowledged the above findings.