Every finding on record at Health One Homecare, Inc

The following Condition level deficiencies were identified during a Medicare authorized recertification Emergency Preparedness survey conducted by the Michigan Department of Licensing and Regulatory Affairs from 11/28/22 to 11/30/2022 at: Health One Homecare 28592 Orchard Lake Road, Suite 303 Farmington Hills, MI 48334 This agency maintains no branch sites. At the conclusion of the survey, the agency was found to be out of compliance with the regulatory requirements at 42 CFR 484.102, Emergency Preparedness.

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: This condition of Participation has NOT been met. Based on record review and interview, the Agency failed to complete an Emergency Preparedness Plan that was based on a facility and community based risk assessment (E0006); the facility failed to develop and maintain an emergency preparedness communication plan that included contact information for all patient physician's (E0030); failed to develop and maintain an emergency preparedness training and testing program for staff based on the agency's emergency plan, resulting in agency personnel not being educated in actions to take in the event of an actual disaster. This deficient practice could affect all 10 patients currently serviced by this Agency (E0036). The cumulative effect of these systemic problems could potentially have a negative effect on all patients cared for by the home health agency in the event staff is not properly prepared for an emergency for the Condition of Participation of 42 CFR §485.102, Emergency Preparedness.

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), §485.625(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 interview and record review, the Agency failed to conduct a facility-based and community-based risk assessment resulting in the potential for failure to identify hazards associated with the facility and less than optimal outcomes during an emergency event. This could potentially affect staff, and all patients serviced by this agency in the event of an emergency. Findings include: On 11/30/22 at 10:00 am., the CM#1 (Clinical Manager #1) was asked if the agency had conducted the required risk assessment and reported, "It has not been updated." Upon review of the presented documentation, there was no evidence that the facility conducted a risk assessment utilizing an all-hazards approach with regards to natural, man-made, facility and geographic related emergencies.

Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(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:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: Based on record review and interview, it was determined that the facility failed to develop and maintain an emergency preparedness communication plan that included contact information for all patient physician's, which had the potential to negatively affect the health and safety of the patients serviced by this agency, resulting in the lack of effective communication in the event of an actual emergency. Findings include: On 11/30/22, review of the Agency's Emergency Preparedness Plan (EP) failed to provide any evidence that a review or updates had been documented. This deficient practice was confirmed during an interview with CM#1 (Clinical manager #1) on 11/30/22 at 10:00 am and confirmed the findings stating, "Yes, the physicians contact information for the patients is not there."

EP Training and Testing CFR(s): 484.102(d) §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, CAHs at §486.625, "Organizations" under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to develop and maintain an emergency preparedness training and testing program for staff based on the agency's emergency plan, resulting in agency personnel not being educated in actions to take in the event of an actual disaster. This deficient practice could affect all patients serviced by this Agency. Findings include: During review of the agency's Emergency Preparedness documents and policies on 11/30/22, it was noted that the Agency did not have documented evidence that they had developed a training and testing program for staff that was based on the agency's emergency plan. The above findings were reviewed with and confirmed by the CM#1 (Clinical Manager #1) during an interview on 11/30/22 at 10:00 am, who stated, "I do not see the training completed by all staff members.”

A Medicare recertification survey which included a COVID-19 Vaccination protocol review, was conducted by the Michigan Department of Licensing and Regulatory Affairs from 11/28/22 to 11/30/2022 at: Health One Homecare 28592 Orchard Lake Road, Suite 303 Farmington Hills, MI 48334 At the time of the survey, the agency did not have any branch offices or subunits. The services the agency provided were: Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT), Speech Therapy (ST), Medical Social Work (MSW), Registered Dietician (RD), and Home Health Aide (HHa). Clinical records reviewed included: 7 discharge records and 0 home visits due to there being none available. The following Condition level deficiencies were identified at: 42 CFR § 484.60: Care planning, coordination of services, and quality of care. 42 CFR § 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). 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).

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 policy review, record review, and interview, it was determined the Agency (HHA) failed to ensure the initial comprehensive assessment was completed no later than 5 calendar days after the start of care in 1 record (MR#3) from a total of 7 records reviewed, resulting in the potential for unidentified patient needs. Findings included: MR#3: The Start of Care (SOC) was dated 9/19/22. The referral identified diagnoses of Hypertension, Low Back Pain and Chronic Pain Symptom. During record review on 11/29/22, it was noted that the comprehensive assessment dated 9/19/22 had not been completed by the Registered Nurse. The first page of the OASIS (Outcome Assessment Information Set) has been completed and the remaining 20 pages are blank. These findings were reviewed with and acknowledged by the Administrator (Adm#1) and Clinical Manager (CM#1) during an interview on 11/30/22 at 11:45 am.

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 by a registered nurse in 4 records (MR #1, 2, 3, 7), from a total of 7 sampled records reviewed, resulting in the potential for harmful medication effects for all patients serviced by this Agency. Findings include: MR#1: The Start of Care (SOC) was dated 5/26/22. The Plan of Care (POC) identified diagnoses of Hemiplegia following CVA, Difficulty with walking and Hypertension. During record review on 11/28/22, it was noted that the Physical Therapist completed the “Medication Profile” on 5/26/22 and there was no documented evidence that the patient's medications had been reviewed by a registered nurse for possible drug interactions and duplicate drug therapy. MR#2: The Start of Care (SOC) was dated 10/17/22. The Plan of Care (POC) identified diagnosis of Hypertension. During record review on 11/28/22, it was noted that the Physical Therapist completed the “Medication Profile” on 10/17/22 and there was no documented evidence that the patient's medications had been reviewed by a registered nurse for possible drug interactions and duplicate drug therapy. MR#3: The Start of Care (SOC) was dated 9/19/22. The referral identified diagnoses of Hypertension, Low Back Pain and Chronic Pain Symptom. During record review on 11/29/22, it was noted that the medication profile is not signed or dated by a registered nurse. MR#7: The Start of Care (SOC) was dated 8/5/22. The Plan of Care (POC) identified diagnoses of Osteoarthritis, Chronic Obstructive Pulmonary Disease and Hypertension. During record review on 8/5/22, it was noted that the Physical Therapist completed the “Medication Profile” on 8/5/22 and there was no documented evidence that the patient's medications had been reviewed by a registered nurse for possible drug interactions and duplicate drug therapy. These findings were reviewed with and acknowledged by the Administrator (Adm#1) and Clinical Manager (CM#1) during an interview on 11/30/22 at 11:50 am.

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, it was determined that the Agency failed to develop a written plan of care in 1 (MR's #3) of 7 records, resulting in the potential for decline in physical functioning and unmet care needs (G572); failed to ensure the plan of care was individualized to the patient's identified needs for 1 of 7 records reviewed (MR#3), resulting in an incomplete plan of care and the potential for poor patient outcomes (G574); failed to ensure that all drugs, care, and services were provided only in accordance with Physician's orders for 1 (MR#3) of 7 records reviewed, resulting in the potential for the provision of unsafe, unauthorized care and unmet care needs (G580). The cumulative effect of these systemic problems resulted in the home health agency's Immediate Jeopardy and 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, the agency failed to develop a written plan of care for 1 of 7 records reviewed (MR#3), resulting in no plan to specify the care and services necessary to meet the needs of the patient. This deficient practice has the potential to negatively affect the quality of care and services. Findings include: MR#3: The Start of Care (SOC) was dated 9/19/22. The referral identified diagnoses of Hypertension, Low Back Pain and Chronic Pain Symptom. During record review on 11/29/22, it was noted that there was no plan of care developed for this patient. The Registered Nurse started a comprehensive assessment on 9/19/22 which remains incomplete. Physical Therapy completed an evaluation on 9/21/22. Occupational Therapy completed an evaluation on 9/22/22. The Licensed Practical Nurse completed visits on 9/21/22, 9/28/22, 10/4/22 and 10/12/22 without a plan of care that directed specific patient orders, interventions, and goals. The agency failed to develop a plan of care, and thus has the potential to negatively affect the quality of care and services provided. These findings were reviewed with and acknowledged by the Administrator (Adm#1) and Clinical Manager (CM#1) during an interview on 11/30/22 at 11:45 am. Adm#1 stated, “The nurse that completed the visit and started the comprehensive assessment went into labor shortly after seeing that patient.” Adm#1 was questioned on the date and time of labor and was unsure.

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 was patient specific and individualized to the patient's identified needs, covered all pertinent interventions with reportable parameters for 1 of 7 records reviewed (MR#3), resulting in patients not receiving care specific to their needs and the potential for poor patient outcomes. Findings included: **Agency Policy: "Plan of Care – CMS #485 and Physician/Practitioners Orders," (Undated). The policy states, " ...4. The individualized plan of care must include the following: All pertinent diagnoses. The patient’s mental, psychosocial, and cognitive status. The types of services, supplies and equipment required. The frequency and duration of visits to be made. Prognosis. Rehabilitation potential. Functional limitations. Activities permitted. Nutritional requirements. All medications and treatments. Safety measures to protect against injury…." MR#3: The Start of Care (SOC) was dated 9/19/22. The Plan of Care (POC) identified diagnoses of Hypertension, Low Back Pain and Chronic Pain Symptom. During record review on 11/29/22, it was noted that there was no plan of care developed for this patient. The agency failed to develop an individualized and patient specific plan of care. These findings were reviewed with and acknowledged by the Administrator (Adm#1) and Clinical Manager (CM#1) during an interview on 11/30/22 at 12:05 pm.

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure all patient skilled nursing intervention orders were recorded in the plan of care in 1 record (MR# 3) of 7 sampled records reviewed, resulting in a lack of physician oversight and input regarding the patient's plan of care and the potential for services not provided as ordered. Findings included: **Agency policy "Care Planning Process" (undated) stated, "The patient care plan for Skilled Nursing will be: Initial care plan will be CMS #485 Plan of Care, which is developed and implemented with physician/practitioner. Demonstrates problems (diagnoses), interventions (physician/practitioner orders) and long-range goals…” MR#3: The Start of Care (SOC) was dated 9/19/22. The Plan of Care (POC) identified diagnoses of Hypertension, Low Back Pain and Chronic Pain Symptom. During record review on 11/29/22, it was noted that there was no plan of care developed for this patient. The agency failed to ensure all patient skilled nursing intervention orders were recorded in a plan of care, thus resulting in the potential for services not provided as ordered. These findings were reviewed with and acknowledged by the Administrator (Adm#1) and Clinical Manager (CM#1) during an interview on 11/30/22 at 11:45 am.

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, the agency failed to ensure that all drugs, care and services were provided only in accordance with Physician's orders for 1 (MR #1) of 7 records reviewed, resulting in the potential for the provision of unsafe, unauthorized care and unmet care needs. Findings include: MR#3: The Start of Care (SOC) was dated 9/19/22. The Plan of Care (POC) identified diagnoses of Hypertension, Low Back Pain and Chronic Pain Symptom. During record review on 11/29/22, it was noted that there was no plan of care developed for this patient. The Registered Nurse started a comprehensive assessment on 9/19/22 which remains incomplete. The medication profile is unsigned by a Registered Nurse. The Licensed Practical Nurse completed visits on 9/21/22, 9/28/22, 10/4/22 and 10/12/22 without a plan of care that directed specific patient orders, interventions, and goals. These findings were reviewed with and acknowledged by the Administrator (Adm#1) and Clinical Manager (CM#1) during an interview on 11/30/22 at 11:45 am.

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 policy review and interview, it was determined the home health agency failed to develop a Quality Assessment and Performance Improvement (QAPI) policy and program, (G-642); the agency failed to collect and monitor data for the Quality Assessment and Performance Improvement (QAPI) program, (G-644); failed to document the quality improvement projects for 2020, 2021, and 2022 and document the reasons for conducting these projects and the measurable progress achieved each year (G-658). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care for all the patients the Home Health Agency serves for the condition of participation of 42 CFR§484.65 Quality Assessment and Performance Improvement (QAPI).

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 develop, implement, and maintain a quality assessment and performance improvement program which had the potential to negatively affect all 24 patients that were admitted during the past 12 months, resulting in a potential for poor patient outcomes due to the provision of substandard care. Findings include: The agency's Quality Assessment and Performance Improvement (QAPI) documentation was reviewed on 11/30/22. There was no documentation to support the agency's performance improvement activities regarding their efforts to systematically collect data, monitor, analyze and improve patient outcomes. The QAPI binder contained documentation and instructions for a QAPI program and CASPER (Certification and Survey Provider Enhanced Reports) documentation, but had no additional data added, and thus was unable to quantitively demonstrate improvements. The CM#1 (Clinical Manager#1) was questioned regarding QAPI indicators and process to measure on 11/30/22 at 9:45 am and stated, "We have downloaded all of our CMS CASPER reports, but we have not yet tabulated to show measurable improvements." The agency failed to ensure their QAPI program was at least capable of showing measurable improvements in indicators to improve patient outcomes, safety and quality of care.

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, it was determined the agency failed to collect and use data to monitor the effectiveness, safety of services and quality of care and identify opportunities for improvement by the quality assessment and performance improvement program, which had the potential to negatively affect all patients serviced by the agency, resulting in a potential for poor patient outcomes due to the provision of substandard care. Findings include: During an interview on 11/30/22 at 9:45 am a request was submitted to review the QAPI (quality assessment performance improvement) documents for 2020, 2021 and 2022. There was no documentation to support the agency's performance improvement activities regarding their efforts to systematically collect data, monitor, analyze and improve patient outcomes. The QAPI binder contained documentation and instructions for a QAPI program and CASPER (Certification and Survey Provider Enhanced Reports) documentation, but had no additional data added, and thus was unable to quantitively demonstrate improvements.

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 interview and record review, it was determined the Agency failed to develop a Quality Assessment Performance Improvement program that documented the annual quality improvement projects, the reasons for conducting these projects with measurable progress achieved on these projects for the 2020, 2021 and 2022 calendar years, resulting in the Agency's inability to improve in patient care, health outcomes, patient safety, quality of care and the agency's performance. Findings include: On 11/30/22 at 9:45 am during an interview, the CM#1 (Clinical Manager#1) was queried about documentation of the Agency's QAPI (Quality Assessment Performance Improvement) program and Performance Improvement Projects, reasons for conducting the projects along with measurable progress achieved. CM#1 (Clinical Manager#1) was unable to provide the requested data and stated, "We do not have any improvement projects."

Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure infection control education was provided to staff employed or contracted by the agency in 4 of 4 personnel files reviewed (Adm#1, CM#1, RN#1, Intake#1), resulting in a lack of knowledge and training regarding current infection prevention/treatment practices in the home setting. Findings include: Agency policy: “Infection Control Plan” (Undated) stated, “Procedure 3. Establishes a training program upon employment which: - Educates employees in the infection control program." During personnel files review on 11/30/22 at 9:30 am, it was noted that the personnel files for Adm#1, CM#1, RN#1 and Intake#1 contained no evidence of any infection control education. CM#1 confirmed the files did not contain any infection control education.

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 discharge summary was complete, provided the patient's current health status at the time of discharge, progress toward goals, and forwarded to the physician within 5 days of discharge in 7 (MR#s 1-7) of 7 closed 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 5/26/22. The Plan of Care (POC) identified diagnoses of Hemiplegia following CVA, Difficulty with walking and Hypertension. During record review on 11/28/22, it was noted that the agency failed to verify that the discharge summary was sent to the physician within 5 business days of the patient's discharge. MR#2: The Start of Care (SOC) was dated 10/17/22. The Plan of Care (POC) identified diagnosis of Hypertension. During record review on 11/28/22, it was noted that the agency failed to verify that the discharge summary was sent to the physician within 5 business days of the patient's discharge. MR#3: The Start of Care (SOC) was dated 9/19/22. The referral identified diagnoses of Hypertension, Low Back Pain and Chronic Pain Symptom. During record review on 11/29/22, it was noted that the agency failed to verify that the discharge summary was sent to the physician within 5 business days of the patient's discharge. MR#4: The Start of Care (SOC) was dated 3/15/22. The Plan of Care (POC) identified diagnosis of Osteoarthritis Bilateral Knees. During record review on 11/28/22, it was noted that the agency failed to verify that the discharge summary was sent to the physician within 5 business days of the patient's discharge. MR#5: The Start of Care (SOC) was dated 1/17/22. The Plan of Care (POC) identified diagnoses of Venous Insufficiency, Ulcer Right Ankle, Diabetes Type 2 and Chronic Kidney Failure. During record review on 11/29/22, it was noted that the agency failed to verify that the discharge summary was sent to the physician within 5 business days of the patient's discharge. MR#6: The Start of Care (SOC) was dated 8/4/22. The Plan of Care (POC) identified diagnoses of Diabetes Type 2, Hypertension, Osteoarthritis and Difficulty Walking. During record review on 11/29/22, it was noted that the agency failed to verify that the discharge summary was sent to the physician within 5 business days of the patient's discharge. MR#7: The Start of Care (SOC) was dated 8/5/22. The Plan of Care (POC) identified diagnoses of Osteoarthritis, Chronic Obstructive Pulmonary Disease and Hypertension. During record review on 8/5/22, it was noted that the agency failed to verify that the discharge summary was sent to the physician within 5 business days of the patient's discharge. These findings were reviewed with and acknowledged by the Administrator (Adm#1) and Clinical Manager (CM#1) during an interview on 11/30/22 at 11:45 am.