Every finding on record at 1st State Home Healthcare, Inc

A Medicare Emergency Preparedness survey was conducted from 7/6/26 through 7/8/26 by the Michigan Department of Licensing and Regulatory Affairs at: 1st State Home Healthcare 138 Harrow Lane suite 3 Saginaw, MI 48638 At the time of the survey, the agency did not operate any branch offices. For this survey, seven records were reviewed, and two home visits were conducted (Only two visits were available). At the conclusion of the survey the agency was found to be in substantial compliance with the conditions of participation for home health agencies at 42 CFR Part 484.102.

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined that the agency failed to maintain documentation of emergency preparedness training, resulting in the potential for inappropriate, unprepared responses to emergencies and an interruption in the provision of needed patient care and services. Findings include: During a review of the agency's emergency preparedness (EP) program, it was discovered that no sign-in sheets were available to document the 4 employees' participation in the EP ongoing annual training. The agency failed to document their employees ongoing annual EP training after their initial training. Staff-A had no documented annual training since 2012. Staff-B had no documented annual EP training for 2025. Staff-C had no documented annual training since 2022, and Staff-D had no documented training since 2023. During an interview on 7/8/26 at 6:00 PM, the Administrator (Staff-A) acknowledged the above findings.

A Medicare recertification survey was conducted from 7/6/26 through 7/8/26 by the Michigan Department of Licensing and Regulatory Affairs at: 1st State Home Healthcare 138 Harrow Lane suite 3 Saginaw, MI 48638 At the time of the survey, the agency did not operate any branch offices. For this survey, seven records were reviewed, and two home visits were conducted (Only two visits were available). At the conclusion of the survey the agency was found to be in substantial compliance with the conditions of participation for home health agencies at 42 CFR Part 484.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure that 2 (P-1, P-4) of 7 patients were included in the overall planning of their care, resulting in a lack of inclusion in planning their care, the potential for missed visits and unmet care needs. Findings include: Patient #1 (P-1): P-1’s start of care (SOC) was 4/28/26, with diagnoses of type 2 diabetes mellitus, hemiplegia, and chronic obstructive pulmonary disease (COPD). P-1's referral dated 4/22/26, had skilled nursing (SN), physical therapy (PT), and occupational therapy (OT) ordered. The consent to treat dated 5/21/26, only had PT services on it. During review of P-1's record on 7/6/26, at 1:30 PM, it was discovered that PT was the only service provided. There was no documented evidence that the patient refused SN or OT services or that the physician was notified that the services were not provided. Patient #4 (P-4): P-4’s start of care (SOC) was 4/14/26, with diagnoses of heart failure, atherosclerotic heart disease of coronary arteries, and acute kidney failure. P-4's referral dated 4/8/26, had SN and PT ordered. The consent to treat dated 4/14/26, only had PT services on it. During review of P-4's record on 7/8/26, at 9:15 AM, it was discovered that PT was the only service provided. There was no documented evidence that the patient refused SN services or that the physician was notified that the service was not provided. During an interview on 7/8/26 at 6:00 PM, the Administrator (Staff-A) acknowledged the above findings.

Contact info Federal/State-funded entities CFR(s): 484.50(c)(10)(i,ii,iii,iv,v) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: (i) Agency on Aging (ii) Center for Independent Living (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. This ELEMENT is not met as evidenced by: Based on record review, and interview, it was determined the Home Health Agency (HHA) failed to inform their patients of the names, addresses and phone numbers of the Federally funded and State funded entities, in the areas where their patients reside, resulting in failure to provide access to community resources and services for the agency's patients. Findings included: During review of the agency's patient admission packet on 7/6/26 at 10:30 a.m. it was discovered that the folder failed to include the names, addresses and phone numbers of all five Federally and State funded entities (Agency on Aging, Center for Independent Living, Protection and Advocacy Agency, Aging and Disability Resource Center and Quality Improvement Organization). The home health agency failed to provide the contact information for the Federally and State funded entities that provide community services and resources to the agency's patients. During an interview on 7/8/26 at 6:00 PM, the Administrator (Staff-A) acknowledged the above findings.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: (1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to conduct a patient-specific, comprehensive assessment that accurately reflected the patient's current health status in 6 of 7 records reviewed (P1, P2, P3, P4, P5, P7), resulting in incomplete clinical information to aide in determining the needs of the patient. Findings included: Patient #1 (P-1): P-1’s start of care (SOC) was 4/28/26, with diagnoses of type 2 diabetes mellitus, hemiplegia, and chronic obstructive pulmonary disease (COPD). During review of the record on 7/6/26 at 1:30 PM, it was discovered that the OASIS Comprehensive Assessment dated 4/28/26, under the Significant Past Health History Section, was blank, and the endocrine system section was blank, but the Plan of Care documented multiple diagnoses, including Type 2 Diabetes Mellitus as the primary, hemiplegia, chronic obstructive pulmonary disease, lumbago, lateral sclerosis, and unsteadiness on feet. There is also no baseline blood sugar on the comprehensive assessment with a primary diagnosis of Type 2 diabetes mellitus. Patient #2 (P-2): P-2’s start of care (SOC) was 5/21/26, with diagnoses of atherosclerotic heart disease of coronary arteries, diabetes mellitus, and Parkinson's disease. During review of the record on 7/6/26 at 4:00 PM, it was discovered that the OASIS Comprehensive Assessment dated 5/21/26, documented atherosclerotic heart disease of coronary arteries and type 2 diabetes mellitus as diagnoses, but the endocrine and cardiac system sections are both blank. There is no past medical history or information related to the primary and secondary diagnoses documented in the Start of Care Comprehensive OASIS Assessment. Patient #3 (P-3): P-3’s start of care (SOC) was 12/13/23, with diagnoses of heart failure, pneumonia, and chronic obstructive pulmonary disease. During review of the record on 7/7/26 at 2:30 PM, it was discovered that the OASIS Recertification Assessment dated 3/31/26, documented heart failure, pneumonia, and chronic obstructive pulmonary disease (COPD), but the cardiac and respiratory system sections are both blank. There is no past medical history or information related to the above diagnoses documented in the Start of Care Comprehensive OASIS Assessment. Patient #4 (P-4): P-4’s start of care (SOC) was 4/14/26, with diagnoses of heart failure, atherosclerotic heart disease of coronary arteries, and acute kidney failure. During record review on 7/8/26 at 9:14 AM, it was discovered that the OASIS Comprehensive Assessment dated 4/14/26, documented heart failure and arteriosclerosis of coronary arteries, but the cardiac system section is blank. There is no past medical history or information related to the above diagnosis documented in the Start of Care Comprehensive OASIS Assessment. Patient #5 (P-5): P-5’s start of care (SOC) was 11/28/23, with diagnoses of malignant neoplasm, lymph disorder and atrial fibrillation. During review of the record on 7/8/26 at 11:30 AM, it was discovered that the OASIS Comprehensive Assessment dated 5/15/26, does not have any diagnoses documented. The Plan of Care dated 5/16/26 documents multiple diagnoses, including malignant neoplasm, lymph disorder, and atrial fibrillation. Patient #7 (P-7): P-7’s start of care (SOC) was 3/7/26, with diagnoses of heart failure, neuropathy and chronic obstructive pulmonary disease. During review of the record on 7/8/26 at 11:30 AM, it was discovered that the OASIS Recertification Assessment dated 3/7/26, documented heart failure and chronic obstructive pulmonary disease (COPD), but the cardiac and respiratory system sections are both blank. There is no past medical history or information related to the above diagnoses documented in the Start of Care Comprehensive OASIS Assessment. During an interview on 7/8/26 at 6:00 PM, the Administrator (Staff-A) acknowledged the above findings.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment included a review of all the patient's prescribed medications to determine any untoward interactions, for 4 (P-1, P-2, P-3 and P-5) of 7 patient's records reviewed, resulting in the potential for harmful medication effects. Findings include: Patient #1 (P-1): P-1’s start of care (SOC) was 4/28/26, with diagnoses of type 2 diabetes mellitus, hemiplegia, and chronic obstructive pulmonary disease (COPD). During review of the record on 7/6/26 at 1:30 PM, it was discovered that there was no evidence in the record that a medication reconciliation was completed. There is a medication profile, but no reconciliation documented in the record. A medication reconciliation was completed on 7/6/26 and showed 2 minor and 2 moderate drug interactions. There was no documented evidence in the record that the physician was notified of the drug interactions and what follow-up was done. Patient #2 (P-2): P-2’s start of care (SOC) was 5/21/26, with diagnoses of atherosclerotic heart disease of coronary arteries, diabetes mellitus, and Parkinson's disease. During review of the record on 7/6/26 at 4:00 PM, it was discovered that there was no evidence in the record that a medication reconciliation was completed. There is a medication profile, but no reconciliation documented in the record. A medication reconciliation was completed on 7/6/26 and showed 18 moderate drug interactions. There was no documented evidence in the record that the physician was notified of the drug interactions and what follow-up was done. Patient #3 (P-3): P-3’s start of care (SOC) was 12/13/23, with diagnoses of heart failure, pneumonia, and chronic obstructive pulmonary disease. During review of the record on 7/7/26 at 2:30 PM, it was discovered that there was no evidence in the record that a medication reconciliation was completed. There is a medication profile, but no reconciliation documented in the record. A medication reconciliation was completed on 7/7/26 and showed 12 moderate and 4 major drug interactions. There was no documented evidence in the record that the physician was notified of the drug interactions and what follow-up was done. Patient #5 (P-5): P-5’s start of care (SOC) was 11/28/23, with diagnoses of malignant neoplasm, lymph disorder and atrial fibrillation. During review of the record on 7/8/26 at 11:30 AM, it was discovered that there was no evidence in the record that a medication reconciliation was completed. There is a medication profile, but no reconciliation documented in the record. A medication reconciliation was completed on 7/8/26 and showed 2 minor, 8 moderate and 6 major drug interactions. There was no documented evidence in the record that the physician was notified of the drug interactions and what follow-up was done. Agency policy III.17, Medication Management (undated), stated, "The medications will be reviewed for potential adverse effects, drug reactions, ineffective drug therapy, significant drug interactions, duplicate drug therapy, and for patient non-compliance with drug therapy..." During an interview on 7/8/26 at 6:00 PM, the Administrator (Staff-A) acknowledged the above findings.

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 ensure the frequency of visits ordered on the Plan of Care (POC) were followed in 3 of 7 records reviewed (P-5, P-6 and P-7), resulting in the potential for unmet patient needs. Findings include: Patient #5 (P-5): P-5’s start of care (SOC) was 11/28/23, with diagnoses of malignant neoplasm, lymph disorder and atrial fibrillation. During review of the record on 7/8/26 at 11:30 AM, it was discovered that the Plan of Care dated 5/16/26 had a skilled nursing (SN) visit frequency ordered for 2 visits a week for 8 weeks. There were no documented SN visits during weeks 3, 6, 7, and 8. There were no missed SN visit notes documented in the record. There was a home health aide visit frequency of 2 visits a week for 8 weeks ordered, but there were no documented aide visits for week 7. Patient #6 (P-6): P-6’s start of care (SOC) was 11/28/23, with diagnoses of type 2 diabetes mellitus and hypertension. During review of the record on 7/8/26 at 3:00 PM, it was discovered that the POC dated 5/10/26, had a skilled nursing frequency of 2 visits a week for 8 weeks. There was a missed skilled nursing visit noted during week 5, with no missed visit note documented in the record. Patient #7 (P-7): P-7’s start of care (SOC) was 3/7/26, with diagnoses of heart failure, neuropathy and chronic obstructive pulmonary disease. During review of the record on 7/8/26 at 11:30 AM, it was discovered that the POC had physical therapy services ordered at a frequency of 1 visit a week for 2 weeks, then 1 visit a week for 7 weeks. Week 2 had a missed PT visit with no note documented in the record. During an interview on 7/8/26 at 6:00 PM, the Administrator (Staff-A) acknowledged the above findings.

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 (POC) included all safety measures for 1 of 1 (P-7) records with oxygen ordered, resulting in the potential for negative patient outcomes related to oxygen use. Findings include: Patient #7 (P-7): P-7’s start of care (SOC) was 3/7/26, with diagnoses of heart failure, neuropathy and chronic obstructive pulmonary disease. During review of the record on 7/8/26 at 11:30 AM, it was discovered that oxygen therapy was ordered but there were no oxygen precautions or safety measures on the Plan of Care (POC). Agency policy III.7 Professional/Ancillary Care Plan (undated) stated, "The POC will include.... safety measures, including use of specific equipment." During an interview on 7/8/26 at 6:00 PM, the Administrator (Staff-A) acknowledged the above findings.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure a detailed discharge summary was included in the record for 1 of 2 discharge patient (P-2) records reviewed, resulting in a lack of information to the receiving facility or the patient's physician to ensure continuity of care. Findings include: Patient #2 (P-2): P-2’s start of care (SOC) was 5/21/26, with diagnoses of atherosclerotic heart disease of coronary arteries, diabetes mellitus, and Parkinson's disease. During review of the record on 7/6/26 at 4:00 PM, it was discovered that there was no discharge summary in the patient’s record that identifies the patient’s medications, past medical history, goals achieved/progress, or patient condition at discharge. There is no information to provide continuity of care to the receiving facility or information to the primary care physician. During an interview on 7/8/26 at 6:00 PM, the Administrator (Staff-A) 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 ensure a detailed discharge or transfer summary was included in the record and sent to the receiving facility or the patient's physician within 5 business days of discharge for 2 of 2 transfer or discharge patient (P-1, P-2) records reviewed, resulting in a lack of information to ensure continuity of care. Findings include: Patient #1 (P-1): P-1’s start of care (SOC) was 4/28/26, with diagnoses of type 2 diabetes mellitus, hemiplegia, and chronic obstructive pulmonary disease (COPD). During review of the record on 7/6/26 at 1:30 PM, it was discovered that there was no discharge/transfer summary in the record. There is a transfer OASIS dated 5/14/26 that does not include a summary, medications, past medical history or patient condition at transfer to provide continuity of care to the receiving facility and information to the primary care physician. Patient #2 (P-2): P-2’s start of care (SOC) was 5/21/26, with diagnoses of atherosclerotic heart disease of coronary arteries, diabetes mellitus, and Parkinson's disease. During review of the record on 7/6/26 at 4:00 PM, it was discovered that there was no discharge summary in the patient’s record that identifies the patient’s medications, past medical history, goals achieved/progress, or patient condition at discharge. There is no information to provide continuity of care to the receiving facility or information to the primary care physician. During an interview on 7/8/26 at 6:00 PM, the Administrator (Staff-A) acknowledged the above findings.

On March 14, 2023, through March 17, 2023, an Emergency Preparedness survey was conducted by the Michigan Department of Licensing and Regulatory Affairs. At the survey, 1st State Home Healthcare was found to be not in compliance with the requirements for participation in Medicare at 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), §485.542(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 ensure their emergency preparedness plan was reviewed and updated at least every 2 years. These practices could negatively affect the health and safety of the agency's 6 current patients in the event of an agency-based emergency or community disaster. Findings include: The agency's binder titled, Emergency Preparedness Plan, was reviewed with Admin-A (administrator) on 3/15/23 at 4:10 p.m. During the review it was noted that the agency's hazard and vulnerability assessment was last revised in March 2020. It was also noted in section 3.A Disaster Management Team, that the incident commander (Staff-E) and the back-up incident commander (Staff-F) included names of employees that do not work at the agency. Admin-A reviewed the finding at the time of discovery and explained he did not know who Staff-E and Staff-F were or how the names were incorporated into the agency's preparedness plan. There was no documentation to indicate the agency's plan was reviewed and updated with correct information at least every 2 years.

Homebound HHA/Hospice Inform EP Officials CFR(s): 484.102(b)(2) §418.113(b)(2), §460.84(b)(4), §484.102(b)(2) [(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. At a minimum, the policies and procedures must address the following:] *[For homebound Hospice at §418.113(b)(2), PACE at §460.84(b)(4), and HHAs at §484.102(b)(2):] The procedures to inform State and local emergency preparedness officials about [homebound Hospice, PACE or HHA] patients in need of evacuation from their residences at any time due to an emergency situation based on the patient's medical and psychiatric condition and home environment. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure to have current information critical to first responders. These practices could negatively affect the health and safety of the agency's 6 current patients in the event of an agency-based emergency or community disaster. Findings include: The agency's binder titled, Emergency Preparedness Plan, was reviewed with Admin-A (administrator) on 3/15/23 at 4:10 p.m. During review of the plan, it was noted that section 3.D Planning-Patient Roster states, "The Clinical Manager is responsible for ensuring that a current patient roster is completed and updated weekly...is available to all managing employees...both via paper and electronic means." The Patient Roster includes patient contact information, physician contact information, patient's priority level (1, 2, 3), caregivers' contact information, identification of patients on life support equipment, and other specific information critical to first responders. Admin-A was asked to provide documentation of the current Patient Roster for review. Admin-A retrieved a blue binder and stated that the Roster did not include information for the agency's 6 current patients. The agency failed to follow its own policies and emergency preparedness plan by failing to maintain a Patient Roster with current information to inform State and local emergency preparedness officials about agency patients in need of evacuation from their residence at any time due to an emergency. Admin-A acknowledged the findings at the time of discovery.

A Medicare recertification survey was conducted on 3/14/23 through 3/17/23 by the Michigan Department of Licensing and Regulatory Affairs at: 1st State Home Healthcare 3630 Shattuck Road, Suite 2 Saginaw, MI 48603 At the time of the survey, the agency did not operate any branch offices. The agency was determined to be in compliance with Covid-19 vaccine requirements. For this survey, seven records were reviewed, and two home visits were conducted. Condition level deficiencies were noted at: 42 CFR §484.55 Comprehensive Assessment of Patients 42 CFR §484.60 Care Planning, Coordination, Quality of Care 42 CFR §484.75 Skilled Professional Services 42 CFR §484.110 Clinical Records As a result of the Condition level noncompliance, the Agency is prohibited for 2 years (from the survey date of 3/17/23) from offering a Home Health Aide training and competency evaluation or a competency evaluation program as specified in 42 CFR §484.80(f)(3).

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure the initial assessment visit was completed within 48 hours of the referral or within 48 hours of the patient's return home for 2 of 7 (MR# 6 and 7) records reviewed (refer to G514); failed to conduct a patient-specific, comprehensive assessment that accurately reflected the patient's current health status based on the patient's past medical history that included dates of onset, treatments and outcomes, history of events leading to the need for current home care services and the referral date in 4 of 7 (MR# 4, 5, 6, and 7) records reviewed (refer to G528); failed to ensure the comprehensive assessment included a review of medications completed by the registered nurse to determine any adverse interactions in 5 of 7 (MR# 1, 2, 3, 4, and 6) records reviewed (refer to G536); failed to provide Home Health aide services to patients with needs for assistance with Activities of Daily Living for 2 of 7 (MR# 6 and 7) records reviewed (refer to G538); failed to ensure the update to the comprehensive assessment warranted recertification for an additional episode of care for 1 of 4 (MR# 3) records reviewed (refer to G544); failed to ensure the comprehensive assessment was updated to include an assessment of the patient's current health status and continuing needs for home health services for 1 of 1 (MR# 6) record reviewed(refer to G546); and failed to provide an updated comprehensive assessment of the patient at discharge for 2 of 2 (MR# 5, 2) discharge records reviewed (refer to G550). Findings include: The cumulative effect of these systemic problems resulted in the Home Health Agency’s inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR §484.55: Comprehensive assessment of patients.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the initial assessment visit was completed within 48 hours of the referral or within 48 hours of the patient's return home in 2 (MR#s 6 and 7) of 7 total records reviewed. Findings included: MR #6: The Start of Care (SOC) was dated 1/10/2023. The Plan of Care (POC) for the certification period 1/10/23 to 3/10/23 identified diagnoses of Chronic Obstructive Pulmonary Disease (COPD), Malignant Neoplasm of Upper Lobe Left Lung, Dependance on supplemental oxygen, Obstructive Sleep Apnea, and Low Back Pain. Upon review of the record, it was noted that on 12/28/22 the agency received a referral from the physician. However, the Start of Care Comprehensive Assessment was not completed until 1/10/23,13 days after the date of the referral. There was no documentation found in the record that the physician had been notified of the reason for the delay of the Start of Care visit. MR#7: The Start of Care (SOC) was dated 5/28/2022. The Plan of Care (POC) for the certification period 5/28/2022 to 9/24/2022 identified diagnoses of Hypertension, Heart Disease, Dizziness and Giddiness, Hearing Loss, Hypoglycemia, and Repeated Falls. Upon review of the record, it was noted the referral was dated 5/23/2022, However, the start of care was dated 5/28/22, 5 days after the date of the referral. There was no documentation found in the record that the physician had been notified of the reason for the delay of the Start of Care visit. These findings were reviewed and acknowledged by the Administrator (Admin-A) during an interview on 3/17/2023 at 1:00 p.m.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to conduct a patient-specific, comprehensive assessment that accurately reflected the patient's current health status based on the patient's past medical history that included dates of onset, treatments and outcomes, history of events leading to the need for current home care services and the referral date in 4 of 7 records reviewed (MR#s 4, 5, 6, and 7), resulting in incomplete clinical information to aid in determining the needs of the patient, and to aid in creating individualized specific goals to address the patient's individualized needs. Findings include: MR #4: This patient was admitted to home care on 5/10/21 with the diagnoses of hypokalemia, urinary tract infection, kidney failure, high blood pressure, Parkinson's Disease and chronic obstructive pulmonary disease. The start of care (SOC) was performed by the physical therapist (Staff B) on 5/10/21. Upon reviewing the SOC packet, it was noted that several sections were left incomplete, including manual muscle testing of upper and lower extremities, range of motion of upper and lower extremities, vital signs, past medical history, communication preferences, psychosocial considerations and pain levels. The administrator (Admin A) acknowledged the findings and stated that he agrees that the records are incomplete during an interview on 3/17/23 at 10:39 a.m. MR #5: This patient was admitted to home care on 12/2/21 with the diagnoses of heart disease, multiple sclerosis, peripheral vascular disease, left shoulder pain and hypotension. During record review on 3/15/23, it was noted that the Comprehensive Assessment packet performed by the registered nurse (Staff D) on 12/2/21 was missing the required M-Codes at M1322, M1330 and M1340 regarding integumentary status. These codes are required on the Outcomes and Assessment Information Set (OASIS) as part of the patient- specific standardized assessment of Medicare patients. During an interview with Admin A on 3/17/23 at 10:55 a.m., he reported that it "should be obvious" due to the previous boxes being marked as no wounds being present but acknowledged the findings. MR #6: The Start of Care (SOC) was dated 1/10/2023. The Plan of Care (POC) for the certification period 1/10/23 to 3/10/23 identified diagnoses of Chronic Obstructive Pulmonary Disease (COPD), Malignant Neoplasm of Upper Lobe Left Lung, Dependance on supplemental oxygen, Obstructive Sleep Apnea, and Low Back Pain. Upon review of the Comprehensive Assessment, it was noted many areas of the Comprehensive Assessment were blank as follows: There was no assessment of the patient's "Ears/Nose/Throat/Mouth for this patient diagnosed with COPD, Cancer of the Upper Left Lung, and dependent on oxygen. There was no baseline numerical pain assessment to determine progress in relieving the patient's pain. The pain assessment consisted of "dull" and "pain relieved by medication/exercise", and "frequently interferes with sleep, frequently limits participation in rehabilitation therapy sessions; frequently interferes with day-to-day activities." There was no measurement of pain on a numerical scale to determine the patient's progress towards relieving pain, or if the pain was worsening as a result of physical therapy services. There was no fall risk assessment completed on the Comprehensive Assessment for this patient at risk for falls due to pain, weakness, and breathing problems due to lung cancer. The Fall Risk Assessment was completely blank with no "Total Score" documented to determine the patient's risk for falls, yet the POC documented under safety measures, "Fall Precautions." The area on the Comprehensive Assessment to document "immunization/screening tests" was blank, therefore no information on risks for COVID-19, flu, pneumonia, TB, or tetanus. There was no documented assessment of "Ears/Nose/Throat/Mouth". Upon review that entire section of the Comprehensive Assessment was blank. The Patient Mood Interview was Incomplete, consisting only of an assessment of "Little interest or pleasure in doing things", the remainder of the assessment was blank with no "Total Severity Score" documented to determine the patient's mood status. Patient Safety/Sanitation Hazards affecting patient was blank. Triage/Risk Code and Disaster Code were both blank on the SOC Assessment. Patient History/Active Diagnoses failed to document the patient's Immunization/Screening Tests Status. That area on the Comprehensive Assessment was blank. Significant Past Health History was also blank, including the status of the patient's Lung Cancer and COPD. There was no information on dates of onset, or treatments provided, and current status of these diseases. Psychosocial status documented there was no caregiver willing and able to assist, and the patient marital status was single, and the patient lived alone, yet no assessment of Community Agencies/Social Service Screening was completely blank failing to assess the patient's Community/Social Service needs. The Patient's care preference for learning was blank and not assessed. The Physical Assessment for Musculoskeletal Status/Range of Motion was not assessed. That area of the Comprehensive Assessment was blank for this patient with a diagnosis of low back pain. The Patients Balance/Gait and transfers were not assessed for this patient who uses a walker for ambulation. This finding included the area for Prosthetic Device/Adaptive equipment which was completely blank for this patient who uses a walker for ambulation. Under the Category of Discharge Plans, the physical therapist documented the Patient's Discharge Goal as "discussed", without indicating the patient's actual discharge goal. MR#7: The Start of Care (SOC) was dated 5/28/2022. The Plan of Care (POC) for the certification period 5/28/2022 to 9/24/2022 identified diagnoses of Hypertension, Heart Disease, Dizziness and Giddiness, Hearing Loss, Hypoglycemia, and Repeated Falls. Upon review of the Comprehensive Assessment, it was noted many areas of the Comprehensive Assessment were blank as follows: The area on the Comprehensive Assessment to document "immunization/screening tests" was blank, therefore no information on risks for COVID-19, flu, pneumonia, TB, or tetanus. Under Endocrine/Hematology, the PT documented the patient was a Type 2 Diabetic, but the rest of the assessment area was blank, such as date of onset, diabetic diet, oral or injectable medication, blood sugar ranges, frequency of monitoring, and the patient's competency with use of a glucometer. Under Cardiopulmonary, the PT documented Heart Problem and irregular heart sounds, with no further information such as what the heart problem was, date of onset, treatments for the problem, thus there was no complete information regarding the patient's heart health. These findings were reviewed and acknowledged by the Administrator during an interview on 3/17/23 at 1:00 p.m.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment included a review of medications completed by the registered nurse to determine any adverse interactions in 5 of 7 records reviewed (MR#s 1, 2, 3, 4, and 6), resulting in the potential for harmful medication reactions or negative outcomes for these patients. Findings include: MR #4 - This patient was admitted to home care on 5/10/21 with the diagnoses of hypokalemia, urinary tract infection, kidney failure, high blood pressure, Parkinson's Disease and chronic obstructive pulmonary disease. The physical therapist completed the start of care on 5/10/21. During record review on 3/14/23, it was noted that the physical therapist (Staff B) completed and signed the medication profile review on 5/10/21 with no medication interactions reported. It was also noted that the Administrator (Admin A) signed a second medication review form on 5/10/21 with moderate interactions reported as well as note stating that the physician was contacted. There was no documentation of a registerted nurse reviewing these findings until 12/12/22 and 12/28/22. During an interview with Admin A on 3/17/23 at 11:55 a.m., Admin A reports that he did not have a nurse working at the time to perform the medication review but acknowledged the findings. MR#1: This patient was admitted to the agency on 4/15/21 with diagnoses of chronic obstructive pulmonary disease, osteoarthritis, and knee pain. The patient was recertified for 10 additional episodes of care from 4/15/21 through the current date of record review on 3/14/23. The comprehensive assessment on 4/15/21 was completed by the physical therapist and the recertification assessment on 2/3/23 were completed by the physical therapist. The medication profile indicates that the medications were reviewed by the physical therapist at each of the 11 certification periods. A drug interaction profile was reviewed and signed by Admin-A on 4/15/21. Admin-A is not a registered nurse. There was no documented evidence that the patient's medications had been reviewed by a registered nurse (RN). During an interview on 3/17/23 at 9:30 a.m., Admin-A reviewed and acknowledged the findings. The agency's policy titled, Comprehensive Assessment and OASIS Data Collection Start of Care (no date) failed to align with Federal regulations and ensure medications were reviewed by an RN. MR#2: This patient was admitted to the agency on 3/01/22 with diagnoses of high blood pressure, cellulitis, and multiple sclerosis. The patient was recertified for 5 additional episodes of care from 3/01/22 through the date of discharge on 2/23/23. The medication profile indicates that the physical therapist reviewed the medications for 5 of the 6 certification periods (3/1/22,4/29/22, 6/28/22, 8/28/22, and 12/21/22). The registered nurse reviewed the medications on the 10/24/22 recertification. A drug interaction profile was reviewed and signed by Admin-A on 3/1/22. There was no documented evidence that the patient's medications had been reviewed by an RN until 10/24/22, which was more than seven months after the patient was admitted to the agency. Admin-A reviewed and acknowledged the findings during an interview on 3/17/23 at 9:30 a.m. MR#3: This 93-year-old patient was admitted to the agency on 9/26/20 with diagnoses of chronic obstructive pulmonary disease, high blood pressure, and atrial fibrillation. The patient was recertified for 14 additional episodes of care from 9/26/20 through the current date of a joint survey home visit with the physical therapist on 3/16/23. The medication profile indicates that the medications were reviewed by the physical therapist at each of the 15 certification periods. A drug interaction profile was reviewed and signed by Admin-A on 9/26/22 and 10/13/22. There was no documented evidence that the patient's medications had been reviewed by an RN. Admin-A reviewed and acknowledged the findings during an interview on 3/17/23 at 9:30 a.m. MR #6: The Start of Care (SOC) was dated 1/10/2023. The Plan of Care (POC) for the certification period 1/10/23 to 3/10/23 identified diagnoses of Chronic Obstructive Pulmonary Disease (COPD), Malignant Neoplasm of Upper Lobe Left Lung, Dependance on supplemental oxygen, Obstructive Sleep Apnea, and Low Back Pain. The Comprehensive Assessment was completed on 1/10/2023 by the Physical Therapist. The Comprehensive Assessment indicated the medications were reviewed by the PT. The PT documented "issues were found during the review and there was a medication follow-up". There was no documented evidence that the medication profile had been reviewed by a Registered Nurse. This finding was reviewed and acknowledged with the Administrator (Admin-A) on 3/17/2023 at 1:00 p.m.

Primary caregiver(s), if any CFR(s): 484.55(c)(6)(i,ii) The patient's primary caregiver(s), if any, and other available supports, including their: (i) Willingness and ability to provide care, and (ii) Availability and schedules; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to provide Home Health aide services to patients with needs for assistance with Activities of Daily Living in 2 (MR#s 6 and 7) of 7 total records reviewed. Findings included: MR#6: The patient was admitted on 1/10/2023 related to diagnoses of Malignant neoplasm of the upper left lobe of the lung, Chronic Obstructive Pulmonary Disease, Dependence on supplemental oxygen, and Obstructive sleep apnea. This patient is dependent on supplemental oxygen, and also is dependent on a walker for ambulation. During a review of the Comprehensive Assessment, it was noted under the Category of Living Arrangement, that this patient lives alone around the clock with functional limitations of endurance and ambulation. The patient has safety measures for Oxygen Precautions, Fall Precautions, and to keep pathways clear. The patient currently uses a walker for ambulation. Under the category of Psychosocial Status, it is documented the patient is single, lives alone, and the patient has no caregiver willing and able to offer assistance. The area on the Comprehensive Assessment for Community Agencies/Social Service Screening is blank, thus a referral was not sent to connect the patient to Medical Social Work Services to assist in providing resources for the patient to fulfill the needed Activities of Daily Living while under the care of the agency. In addition, it was noted the agency failed to offer the patient Home Health Aide Services related to the patient's Assessment for functional abilities such as self-Care with bathing, dressing, use of toilet, meal preparation, and eating. The agency had assessed at the Start of Care that the patient needed some help with these activities, yet the agency failed to provide Home Health aide services to assist with these activities while receiving services from the agency. The agency failed to provide Home Health aide services for this patient identified and assessed to have the need while providing services to the patient. MR#7: The Start of Care (SOC) was dated 5/28/2022. The Plan of Care (POC) for the certification period 5/28/2022 to 9/24/2022 identified diagnoses of Hypertension, Heart Disease, Dizziness and Giddiness, Hearing Loss, Hypoglycemia, and Repeated Falls. The patient uses a walker for ambulation. Upon review of the Comprehensive Assessment, it was noted under the category of living arrangements, that the patient lived alone around the clock. Under Self-Care Status, it was documented, "Patient provides their own total care, but does not feel safe providing her own care. Patient has vertigo, strength is poor, and balance is poor." Under Living Arrangements/Supportive Assistance, the PT documented Not Applicable." This patient is moderately hearing impaired with symptoms of vertigo, tinnitus, and vestibular issues, and under the category of pain the PT documented the following activities were affected: "Dressing and undressing the upper and lower body, has difficulty walking, self-care and ADL's." During a survey home visit, on 3/15/2023 at 2:30 p.m., it was observed the patient walking with a walker. The patient's stride was slow and unsteady. During the visit the Pta had enquired if anyone was assisting with bathing, and the patient responded, "No, I have to do it myself." The PTa asked the patient, "how did that go?" The Patient responded, "it took me a long time, I have to take it slow, or I am afraid of falling." The agency failed to provide Home Health aide services for this patient identified and assessed to have the need while providing services to the patient and is assessed to be at risk for falling. These findings were reviewed and acknowledged during an interview with the Administrator (Admin-A) on 3/17/2023 at 1:00 p.m. Admin-A stated, "our agency does not offer Occupational Therapy, Medical Social Work, or Aide Services."

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the update to the comprehensive assessment warranted recertification for an additional episode of care for 1 of 4 (MR# 3) records reviewed in which patient care was recertified for additional episodes of care, resulting in the provision of home care services to a patient without documentation to support the need for continued care and services. Findings include: MR#3: This 93-year-old patient was admitted to the agency on 9/26/20 with diagnoses of chronic obstructive pulmonary disease, high blood pressure, and atrial fibrillation. The patient was recertified for 14 additional episodes of care from 9/26/20 through the current date of a joint survey home visit with the physical therapist on 3/16/23. The patient receives physical therapy (PT) services. During record review on 3/15/23, it was noted that the 1/14/23 physician order documents the following reasons to explain why the patient must be recertified for continued PT services: Patient needs further PT due to pain in joints which interferes with safety and activities of daily living; patient has generalized muscle weakness in bilateral lower extremity; patient has poor standing and dynamic balance; has difficulty walking due to pain and weakness; and patient has shortness of breath with activities. The 1/13/23 physical therapy update of the comprehensive assessment for recertification was conducted and documented by Staff-B (physical therapist). During review of the updated assessment, it was noted that the following areas of the assessment were blank of information: musculoskeletal status, muscle strength against gravity, range of motion, balance/gait, transfers, endurance, joints, physical therapy interventions, fall risk, vital signs, pain rating and description, respiratory status, cardiac status, and the patient's ability to manage medications. The incomplete assessment documented by Staff-B failed to support the reasons for recertification of this patient as noted in the 1/14/23 physician order written by Staff-B. The findings were reviewed with the Administrator (Admin-A) during an interview on 3/17/23 at 9:30 a.m. Admin-A explained that if the agency does not recertify the patient, then the doctor will send the patient to another agency.

Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment was updated to include an assessment of the patient's current health status and continuing needs for home health services for 1 (MR #6) of 1 record reviewed in which a request for recertification of the patient by the agency was submitted as a verbal order dated one day after the end of the prior 60-day SOC certification. Findings included: MR #6: The Start of Care (SOC) was dated 1/10/2023. The Plan of Care (POC) for the certification period 1/10/23 to 3/10/23 identified diagnoses of Chronic Obstructive Pulmonary Disease (COPD), Malignant Neoplasm of Upper Lobe Left Lung, Dependance on supplemental oxygen, Obstructive Sleep Apnea, and Low Back Pain. The patient was receiving Physical Therapy Services. Upon review of the record, a verbal order was noted with an effective date of 3/11/2023 for recertification of the patient. During a review of the Start of Care OASIS and Plan of Care, the prior certification period was dated 1/10/2023 to 3/10/23. This newly requested re-certification period was requested to begin on 3/11/2023 and thus would not occur within the required last 5 days of the prior 60-day certification period. There was no documentation indicating there was a beneficiary elected transfer, significant change in condition, or discharge and return to the same agency during the original 60-day episode. The result of this plan by the agency could have the potential for the rendering of ineffective treatment, services, and unmet care needs if the recertification had occurred one day after the prior 60-day episode. This finding was reviewed and acknowledged by the Administrator (Admin-1) on 3/17/2023 at 1:00 p.m.

At discharge CFR(s): 484.55(d)(3) At discharge. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to provide an updated comprehensive assessment of the patient at discharge for 2 of 2 (MR# 5, 2) discharge records reviewed, resulting in a lack of updated information to summarize the patient's progress in meeting the care plan goals and to inform the physician of any continuing care needs for these patients. Findings include: MR #5: This patient was admitted to home care on 12/2/21 with a diagnosis of heart disease, multiple sclerosis, peripheral vascular disease, left shoulder pain and hypotension. During record review on 3/15/23, it was noted that the patient was discharged from the agency's services on 9/13/22 according to a communication note written by the Administrator (Admin A) on that date. It stated that the patient was discharged due to "...more services needed. Patient is discharged from services and PCP is notified and all others." There is no updated comprehensive assessment in the chart completed by the physical therapist (Staff B), who was the last service to work with the patient. There is no other documentation of the patient's discharge done by Staff B. During an interview with Admin A on 3/17/23 at 11:10 a.m., he reported that the patient refused to have the physical therapist to return to the home to update the comprehensive assessment for discharge, however there is no supporting documentation of this. Admin A acknowledged the findings. MR#2: This patient was admitted to the agency on 3/01/22 with diagnoses of high blood pressure, cellulitis, and multiple sclerosis. During record review on 3/14/23, it was noted that the last documented nursing visit note was dated 2/15/23. It was unclear what had happened with this patient after 2/15/23. There was no documentation of an updated comprehensive assessment to indicate the patient was discharged. During an interview on 3/14/23 at 3:30 p.m., Admin-A was queried regarding the status of this patient. Admin-A explained that the patient was discharged on 2/23/23, but the nurse has been ill and has not turned in documentation of the updated assessment at discharge for this patient. It has been 19 days since the patient was discharged from the agency per Admin-A. The nurse failed to follow the agency's policy titled, III.13 Clinical Record Contents and Maintenance (no date), which states that clinical notes should be written the day of the service delivery, signed, and incorporated into the record at least weekly.

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, policy review, and interview, the agency failed to ensure that the plan of care included objectively, measurable outcomes and goals specific to the patient's needs in 3 of 7 (MR#s 2, 5, and 6) records reviewed; failed to include hearing as a functional limitation in 1 of 7 (MR#7) records reviewed; failed to include nutritional requirements and diet for diagnosis of Hypoglycemia in 1 of 7 (MR#7) records reviewed (refer to G-574); failed to conform to the visit schedule as ordered by the physician in 1 of 7 (MR#6) records reviewed (refer to G578). The cumulative effect of these systemic problems resulted in the Home Health Agency’s inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR §484.60: Care Planning, Coordination, Quality of Care.

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 that the plan of care included objectively, measurable outcomes and goals specific to the patient's needs in 3 of 7 records reviewed (MR#s 2, 5, and 6), failed to include hearing as a functional limitation in 1 of 7 records reviewed (MR#7), and failed to include nutritional requirements and diet for diagnosis of Hypoglycemia in 1 of 7 records, (MR#7) resulting in the patient not receiving care specific to their needs, and the inability to determine the patient's progress towards achieving goals, and the potential for poor patient outcomes. Findings include: MR#2: This patient was admitted to the agency on 3/01/22 with diagnoses of high blood pressure, cellulitis, and multiple sclerosis. The patient was recertified for 5 additional episodes of care from 3/01/22 through the date of discharge on 2/23/23. During record review on 3/14/23, it was noted that the plan of care for the12/26/22 - 2/23/23 recertification period failed to have measurable nursing goals. The following nursing goals were listed on the 12/26/22 plan of care: demonstrate compliance with medication, monitor high blood pressure, monitor circulation, monitor COVID-19, and patient education COVID-19. There were no goals related to the patient's cellulitis and no reportable parameters or goals related to the patient's primary diagnosis of high blood pressure. Monitoring high blood pressure is an ongoing task for the nurse not a measurable goal for the patient. Admin-A reviewed and acknowledged the findings during an interview on 3/17/23 at 9:30 a.m. MR #5: This patient was admitted to home care on 12/2/21 with the diagnoses of heart disease, multiple sclerosis, peripheral vascular disease, left shoulder pain and hypotension. The start of care was completed by the registered nurse (Staff D) on 12/2/21. During record review of the initial plan of care on 3/15/23, it was noted that the nursing goals listed were vague and not measurable. These included: "Demonstrate compliance with medication..." and "Teach set up medications....". These were the only nursing goals listed and are not patient specific or measurable to accurately track the patient's progress. Admin A acknowledged the findings during an interview on 3/17/23 at 10:58 a.m., **Agency Policy: III.6 Physician's Plan of Treatment/Change Orders, no date. The policy states, "...each plan will include: Functional Limitations, Specific, individualized, measurable goals and interventions, including goals related to patient/caregiver education and training." MR #6: The Start of Care (SOC) was dated 1/10/2023. The Plan of Care (POC) for the certification period 1/10/23 to 3/10/23 identified diagnoses of Chronic Obstructive Pulmonary Disease (COPD), Malignant Neoplasm of Upper Lobe Left Lung, Dependance on supplemental oxygen, Obstructive Sleep Apnea, and Low Back Pain. Upon review of the Plan of Care, it was noted the goals were not objectively measurable to determine the patient's progress towards achieving goals. Examples included: "Build energy levels to perform more activities without becoming {sic} tired and shortness of breath by 3/10/23; Patient will improve muscle strength as evidence by walking with less shortness of breath and fatigue by 3/10/23 {sic}; Patient endurance will improve as evidence perform more activities, self-care by 3/10/23 {sic}. These goals are not objectively measurable to determine the patient's progress towards achieving the goals. MR#7: The Start of Care (SOC) was dated 5/28/2022. The Plan of Care (POC) for the certification period 5/28/2022 to 9/24/2022 identified diagnoses of Hypertension, Heart Disease, Dizziness and Giddiness, Hearing Loss, Hypoglycemia, and Repeated Falls. Upon review of the POC, it was noted the goals on the POC were not objectively measurable to determine the patient's progress towards achieving the goals. Examples included: "Patient will be independent with sit to stand from bed to chair to enable her to safe transfer and reduce risk of fall by 9/24/22" {sic}; Patient demonstrate effective pain management to enable self- care and dressing by 9/24/22 {sic}. These goals are not objectively measurable to determine the patient's progress toward achieving the goals. In addition, the patient was diagnosed with unspecified hearing loss, yet Hearing was not identified as a functional limitation on the POC. Also, the patient was diagnosed with hypoglycemia, however the Plan of Care did not include a required nutritional diet to address the patient's hypoglycemia. These findings were reviewed and acknowledged by the Administrator (Admin-1) on 3/17/2023 at 1:30 pm.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to conform to the visit schedule as ordered by the physician in 1 (MR#6) of 7 records reviewed, resulting in patients not receiving care as ordered in the Plan of Care. Findings included: MR #6: The Start of Care (SOC) was dated 1/10/2023. The Plan of Care (POC) for the certification period 1/10/23 to 3/10/23 identified diagnoses of Chronic Obstructive Pulmonary Disease (COPD), Malignant Neoplasm of Upper Lobe Left Lung, Dependance on supplemental oxygen, Obstructive Sleep Apnea, and Low Back Pain. Upon review of the Plan of Care, it was noted the physician ordered Physical Therapy Services to be provided at a frequency of 2 visits a week for 8 weeks. A review of the record revealed 1 missed visit each week for weeks 1, 2, and 5. Further review of the record failed to include any documentation of the patient refusing the visits or notification to the physician of the missed visits. There was no documentation found in the record that any attempts were made to make-up the missed visits that occurred during weeks 1, 2, and 5. Furthermore, there were no physician orders to change the frequency of visits for weeks 1, 2, and 5. The Physical Therapist failed to conform to the visit schedule as ordered by the physician.

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 document review and interview, the agency failed to conduct performance improvement projects in 2022, resulting in no coordinated efforts to improve patient outcomes for the 17 patients admitted to the agency in the past 12 months. Findings include: On 3/16/23, the agency provided for review, a binder titled, QAPI (Quality Assessment and Performance Improvement). The documentation consisted of the agency's data collection and QAPI meetings in 2021, 2022, and 2023. There was no documented evidence of the agency's performance improvement projects in 2022. During an interview on 3/16/23 at 12:30 p.m., the Administrator (Admin-A) reviewed the QAPI binder and acknowledged the findings.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure that the skilled professional staff provided complete assessments and re-assessments with objective measures to accurately assess the patient's health status and function in 5 of 7 (MR#s 2, 3, 4, 5, 7) records reviewed (see G706); failed to ensure that the services of the skilled professionals were provided as indicated by the physician in the plan of care in 4 of 7 (MR#s 2, 3, 4, 5) records reviewed (see G-710); failed to ensure that the skilled professionals prepared clinical notes in 2 of 7 (MR#s 3, 4) records reviewed( see G716); and failed to ensure the Physical Therapist provided supervision of the Physical Therapy Assistant in 2 of 7 (MR#s 3, 6) records reviewed (See G-724) The cumulative effect of these systemic problems resulted in the Home Health Agency’s inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR §484.75: Skilled Professional Services

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure that the skilled professional staff provided complete assessments and re-assessments with objective measures to accurately assess the patient's health status and function in 5 of 7 records reviewed (MR # 2, 3, 4, 5, 7), resulting in the inability to determine patient specific plans of care, treatment, goals and progress towards these goals as well as a potential for unmet care needs for these patients. Findings include: MR #4: This patient was admitted to home care on 5/10/21 with diagnoses of hypokalemia, urinary tract infection, kidney failure, high blood pressure, Parkinson's Disease and chronic obstructive pulmonary disease. During record review on 3/14/23, it was noted that the physical therapy plan of care/re-evaluation on 2/28/23 was missing several components including pain assessment, vitals (on a patient with a high blood pressure diagnosis), range of motion (ROM), manual muscle testing (MMT), functional mobility, gait and balance. There was also no current Tinetti score noted. Upon further review of the document, it was noted that Staff B set goals for strength, transfers, ambulation and Tinetti scores without properly assessing them during the re-evaluation. Therefore, it is unclear as to whether the patient is making progress towards goals set or what their current health status is for this period. The findings were reviewed with the administrator (Admin A) during an interview on 3/17/23 at 10:53 a.m. He acknowledged the findings. MR #5: This patient was admitted to home care with the diagnoses of heart disease, multiple sclerosis, peripheral vascular disease, left shoulder pain and hyoptension. During record review on 3/15/23, it was noted that the physical therapy evaluation on 12/3/21 was missing several components including blood pressure (on a patient with a low blood pressure diagnosis), ROM, MMT, functional mobility and pain (with a left shoulder pain diagnosis). There was also no baseline Tinetti score. Upon further review of the document, it was noted that Staff B set goals for strength, bed mobility, pain management and Tinetti score without having evaluated a baseline. The physical therapy re-certification dated 7/30/22 was also missing upper extremity strength (lower extremity MMT was noted), all ROM measurements and a current Tinetti score. The goals set by Staff B based on this re-evaluation to continue physical therapy services included upper extremity strength, pain management and Tinetti scores. It was also noted in the plan of care document starting 7/30/22 that manual treatment would be provided for the left shoulder, low back and neck without any indication of evaluation of these areas. Without baseline evaluation measurements and measurements during re-evaluations, is it unclear what the patient's current status was and whether he was making progress towards set goals. This also makes it difficult to determine the need for continued services by physical therapy. Admin A acknowledged the findings during an interview on 3/17/23 at 11:08 a.m. MR#2: This patient was admitted to the agency on 3/01/22 with diagnoses of high blood pressure, cellulitis, and multiple sclerosis. The patient was recertified for 5 additional episodes of care from 3/01/22 through the date of discharge on 2/23/23. During record review on 3/14/23, it was noted that the physical therapy (PT) evaluation on 12/27/22 was blank of information in some of the following areas: vital signs, pain, sensory status, integumentary status, musculoskeletal, durable medical equipment, activities of daily living, functional independence/balance evaluation, fall risk, and rehabilitation potential. It was unclear why Staff-B (physical therapist) did not document a complete assessment of this patient to assist in determining the plan of care, treatments, and goals for this 71-year-old patient. The findings were reviewed with and acknowledged by the Administrator (Admin-A) during an interview on 3/17/23 at 9:30 a.m. MR#3: This 93-year-old patient was admitted to the agency on 9/26/20 with diagnoses of chronic obstructive pulmonary disease, high blood pressure, and atrial fibrillation. The patient was recertified for 14 additional episodes of care from 9/26/20 through the current date of a joint survey home visit with the physical therapist on 3/16/23. The patient receives weekly PT services. During record review on 3/15/23, it was noted that the 1/13/23 physical therapy update of the comprehensive assessment for recertification was conducted and documented by Staff-B. Review of the updated assessment indicates the following areas of the assessment were blank of information: musculoskeletal status, muscle strength against gravity, range of motion, balance/gait, transfers, endurance, joints, physical therapy interventions, fall risk, vital signs, pain rating and description, respiratory status, cardiac status, and the patient's ability to manage medications. It was unclear why Staff-B did not document a complete assessment of this patient to assist in determining the continuing care needs for this patient. The findings were reviewed with and acknowledged by Admin-A during an interview on 3/17/23 at 9:30 a.m. MR#7: The patient was admitted to the agency on 5/28/2023 with diagnoses of Hypertension, Heart Disease, Dizziness and giddiness, Hearing Loss, Hypoglycemia, and history of falls. This patient was recertified for 4 additional episodes of care from 5/28/22 to 3/23/23. The patient was receiving Physical Therapy (PT) Services twice weekly. Upon review of the record, it was noted that many areas on the recertification documents were missing information as follows: For the recertification period dated 7/27/22 to 9/24/22 the following information was absent from the Physical Therapy Recertification/Follow-up Assessment included: "Representative Contact Information, Living Arrangements, Immunizations, Eyes, Integumentary Status, Cardiopulmonary including breath sounds, and heart sounds, Systems Review, height, weight, Vital Signs, Abdomen, Endocrine/Hematology, Food/Environmental Allergies, Elimination Staus for Urinary, Genitalia, Neuro, Cognitive Status, Physical Assessment, Functional Mobility Assessment, Strengths/Limitations, Care Preferences, Refused Care, Risk Factors/Hospital Admission/Emergency Room, 30 Day Functional Assessment, Supervisory Visit, Patient/Caregiver/Representative/Family/Education and training, Recertification Summary, Summary of Setbacks/Improvements Since Prior Assessment, Summary Checklist including next visit date, Plan for next visit, and a current copy of the exercises prescribed. Missing information for the Recertification Follow-Up Assessment for the certification period 11/24/22 to 1/22/23 included: Emergency Representative Contact Information, Immunizations, Living Arrangements/Supportive Assistance, Abdomen, Endocrine/Hematology, Bowel Elimination, Genitalia, Neuro, Cognitive Status, Physical Assessment, Functional Mobility Assessment, Strengths and Limitations, Summary of setbacks/improvements since prior assessment, and Summary Checklist, the date for the medical necessity, and the exercise program prescribed by the Physical Therapist. In addition, a copy of the current exercises was not included in the record for this Recertification. For the recertification period 1/22/23 to 3/23/23 the following information was blank from the Physical Therapy Recertification Re-Assessment: "Psychosocial status, Musculoskeletal Status/Physical Therapy Assessment including Range of Motion/Mobility, Muscle Strength Against Gravity, Balance/Gait, Transfers, Joints, Endurance, Sensory Effects on Therapy, Psychosocial/Emotional status which may impact plan of care, Home Structure/Household Barriers that may impact Plan of Care, Prosthetic Device/Adaptive Equipment, Vital Signs, documentation of the patient's pain on a 1-20 scale, bladder, bowel, and endocrine assessments, respiratory status, skin conditions, and discharge plans. In addition, a copy of the current exercises was not included in the record for this Recertification. These findings were reviewed with and acknowledged by the Administrator (Admin-A) during an interview on 3/17/23 at 1:00 p.m.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure that the services of the skilled professionals were provided as indicated by the physician in the plan of care in 4 of 7 records reviewed (MR# 4, 5, 2, 3), resulting in a potential for poor outcomes for these patients. Findings include: MR#2: This patient was admitted to the agency on 3/01/22 with diagnoses of high blood pressure, cellulitis, and multiple sclerosis. During record review on 3/14/23 for the certification period from 12/26/22 to 2/23/23, it was noted on the 12/26/22 plan of care that the physician ordered physical therapy (PT) services to be provided twice weekly for 8 weeks. The PT visit notes indicate that only 1 PT visit was documented the week of 12/25/22. No PT visits were documented the week of 1/1/23. One PT visit note was documented the week of 1/8/23, which was a discharge from therapy visit on 1/11/23. For a total of 4 undocumented visits. There was no documentation regarding missed visits or attempts to schedule visits in those weeks. There was no documentation of communication with the physician regarding missed visits or the change in visit frequency for this plan of care. The physical therapist failed to ensure visits were provided at the frequency ordered by the physician. The findings were reviewed with and acknowledged by Admin-A during an interview on 3/17/23 at 9:30 a.m. MR#3: This patient was admitted to the agency on 9/26/20 with diagnoses of chronic obstructive pulmonary disease, high blood pressure, and atrial fibrillation. The 1/14/23 plan of care ordered physical therapy to provide twice weekly visits for 8 weeks. During record review on 3/15/23 it was noted that the last visit note for review was a missed visit note dated 11/22/22. The patient is a current active patient as of 3/16/23 when a joint survey home visit was conducted with Staff-B (PT). This totals 114 days of no documentation to indicate that PT services were provided as ordered by the physician in the plan of care. The findings were reviewed with Admin-A during an interview on 3/16/23 at 11:10 a.m. Admin-A explained that he has been asking Staff-B for the notes every week, but they haven't been brought into the office. MR #4: This patient was admitted to home care on 5/10/21 with the diagnoses of hypokalemia, urinary tract infection, kidney failure, high blood pressure, Parkinson's Disease and chronic obstructive pulmonary disease. During record review on 3/14/23 for the certification period 12/31/22 to 2/28/23, it was noted on the plan of care that physical therapy services were to be provided twice a week for 8 weeks. Upon review of the physical therapy visit records, it was determined that the weeks of 1/8/23, 1/15/23, 1/22/23 and 1/29/23 only included 1 visit or 1 missed visit documented during each of those weeks. There was no documentation regarding other missed visits or attempts to schedule the patient for another visit during those weeks. There was also no documentation of communication with the physician regarding missed visits or a change in frequency for this plan of care. The administrator (Admin) A states "maybe the patient canceled or refused" but was unable to provide any supporting documentation of this. He acknowledged the findings during an interview on 3/17/23 at 10:46 a.m. MR #5: This patient was admitted to home care on 12/2/21 with the diagnoses of heart disease, multiple sclerosis, peripheral vascular disease, left shoulder pain and hypotension. During record review on 3/15/23 for the certification period of 5/31/22 to 7/29/22, it was noted on the plan of care that physical therapy services were to be provided twice a week for 8 weeks. Upon review of the physical therapy visit records, it was determined that the week of 7/24/22 was missing a second visit. There was no documentation of a missed visit during that week. During an interview with Admin A on 3/17/23 at 11:05 a.m., he stated he did not know why there was not another visit during that week but acknowledged the findings.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure that the skilled professionals prepared clinical notes in 2 of 7 records reviewed (MR# 4, 3), resulting in the clinical record not providing an accurate and up to date clinical picture of the patient and the potential for unidentified health concerns. Findings include: MR#3: This patient was admitted to the agency on 9/26/20 with diagnoses of chronic obstructive pulmonary disease, high blood pressure, and atrial fibrillation. The 1/14/23 plan of care ordered physical therapy (PT) to provide twice weekly visits for 8 weeks. During record review on 3/15/23 it was noted that the last visit note for review was a missed visit note dated 11/22/22. The patient is a current active patient as of 3/16/23 when a joint survey home visit was conducted with Staff-B. This totals 114 days of no documentation of clinical notes. The findings were reviewed with Admin-A during an interview on 3/16/23 at 11:10 a.m. Admin-A explained that he has been asking Staff-B for the notes every week, but they haven't been brought into the office. MR #4: This patient was admitted to home care on 5/10/21 with the diagnoses of hypokalemia, urinary tract infection, kidney failure, high blood pressure, Parkinson's Disease and chronic obstructive pulmonary disease. During record review on 3/15/23, it was noted that this patient was re-certified by the physical therapist (Staff B) for continued physical therapy services from 3/1/23 to 4/29/23 at a frequency of 2 times a week for 8 weeks. Upon review of the physical therapy visit notes, there was no documentation of any physical therapy treatment being provided after the date of 3/1/23. According to the agency policy III.13 Clinical Record Contents and Maintenance, the clinical records "should be written the day of service delivery, signed and incorporated into the record at least weekly." During the entrance interview with the administrator (Admin A) on 3/14/23, he reported that all clinical documentation is due by the end of the day on Tuesday the following week. According to both policies, the chart should have at least contained notes of treatment provided through the end of the week ending on 3/11/23. The agency failed follow it's own written and verbal policies for clinical record keeping. Admin A acknowledged the findings during an interview on 3/17/23 at 10:50 a.m.

Supervise skilled professional assistants CFR(s): 484.75(c) Standard: Supervision of skilled professional assistants. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Physical Therapist provided supervision of the Physical Therapy Assistant in 2 of 7 (MR#s 3 and 6) records reviewed, resulting in a lack of communication and oversight regarding the status of these patients. Findings include: MR#3: This patient was admitted to the agency on 9/26/20 with diagnoses of chronic obstructive pulmonary disease, high blood pressure, and atrial fibrillation. The 1/14/23 plan of care ordered physical therapy (PT) to provide twice weekly visits for 8 weeks. During record review on 3/15/23 it was noted that the last visit note for review was a missed visit note dated 11/22/22. The patient is a current active patient as of 3/16/23 when a joint survey home visit was conducted with Staff-B (PT). This totals 114 days of no documentation to indicate that Staff-B communicated and provided oversight of services provided by Staff-C. Staff-B failed to follow the agency's policy titled, II.6 Supervision and Evaluation of Staff (no date), which states therapists will make visits no less than monthly to patients receiving care by therapy assistants. There was no evidence that Staff-B provided monthly visits to supervise the services of Staff-C. The findings were reviewed with Admin-A during an interview on 3/16/23 at 11:10 a.m. Admin-A explained that there was not a PTA on this case. This statement was inaccurate. Documentation indicates Staff-C provided therapy services to this patient in October and November of 2022 (10/17, 10/19, 10/24, 10/26, 10/31, 11/3, and 11/7). There was no documentation to indicate that Staff-C did not continue to provide services throughout the remainder of care to date on 3/16/23. MR #6: The Start of Care (SOC) was dated 1/10/2023. The Plan of Care (POC) for the certification period 1/10/23 to 3/10/23 identified diagnoses of Chronic Obstructive Pulmonary Disease (COPD), Malignant Neoplasm of Upper Lobe Left Lung, Dependance on supplemental oxygen, Obstructive Sleep Apnea, and Low Back Pain. During a review of the record on 3/16/2023, it was noted that the physical therapy assistant (Staff-C) provided the patient 12 Physical Therapy visits between the dates 1/23/23 through 3/1/23. Upon review of the 12 Physical Therapy Assistant visit notes, it was noted that there was no documentation in any of the notes that the Physical Therapist had supervised any of the Physical Therapy Assistant visits. The area on the visit notes for documentation of the supervisory visits was blank on every PT visit note. This finding was reviewed and acknowledged by the Administrator (Admin-A) on 3/17/2023 at 1:00 p.m.

Assure patient needs are continually assessed CFR(s): 484.105(c)(4) Assuring that patient needs are continually assessed, and This ELEMENT is not met as evidenced by: Based on record review and interview, the clinical manager failed to provide oversight of patient care services and personnel to ensure that patient needs were continually assessed for 1 of 7 (MR# 3) records reviewed, resulting in a lack of assurance that the needs of this patient were assessed and met. Findings include: MR#3: This 93-year-old patient was admitted to the agency on 9/26/20 with diagnoses of chronic obstructive pulmonary disease, high blood pressure, and atrial fibrillation. The patient was recertified for 14 additional episodes of care from 9/26/20 through the current date of a joint survey home visit with Staff-B (physical therapist) on 3/16/23. The patient receives weekly PT services. During record review on 3/15/23, it was noted that the 1/13/23 physical therapy update of the comprehensive assessment for recertification was conducted and documented by Staff-B. Review of the updated assessment indicates the following areas of the assessment were blank of information: musculoskeletal status, muscle strength against gravity, range of motion, balance/gait, transfers, endurance, joints, physical therapy interventions, fall risk, vital signs, pain rating and description, respiratory status, cardiac status, and the patient's ability to manage medications. It was unclear why Staff-B did not document a complete assessment of this patient to assist in determining the continuing care needs for this patient. Also, it was noted that the last visit note for review was a missed visit note dated 11/22/22. The patient is a current active patient as of 3/16/23. From 11/22/22 to 3/16/23 there is 114 days of no documentation to indicate that physical therapy services continually assessed the needs of this patient. The findings were reviewed with Admin-A (administrator) during an interview on 3/16/23 at 11:10 a.m. Admin-A explained that he has been asking Staff-B for the notes every week, but they haven't been brought into the office. The clinical manager (Staff-D) failed to provide oversight of all patient care services and personnel to ensure that patient needs are continually assessed.

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record contained completed assessments and visit notes for 5 of 7 (MR# 2, 3, 4, 5, and 6) records reviewed (refer to G1012); failed to ensure that patient goals were specific and measurable in the patient's plan of care and that the patient's progress towards achieving these goals was documented in 2 of 7 (MR #4, #5) records reviewed (refer to G1016); failed to ensure a detailed discharge summary was sent to the physician within 5 business days of discharge for 2 of 2 (MR# 2, 5) discharge records reviewed (refer to G1022); and failed to ensure documents in the clinical records were legible, clear, complete, and appropriately authenticated with a signature and title, dated, and timed in 5 of 7 (MR#s 1, 3, 4, 5, 6) records reviewed (refer to G1024). Findings include: The cumulative effect of these systemic problems resulted in the Home Health Agency’s inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR §484.110: Clinical Records.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record contained completed assessments and visit notes for 5 of 7 (MR# 2, 3, 4, 5, and 6) records reviewed, resulting in a lack of information for the physician and all agency staff caring for these patients. Findings include: MR #4: This patient was admitted to home care on 5/10/21 with diagnoses of hypokalemia, urinary tract infection, kidney failure, high blood pressure, Parkinson's Disease and chronic obstructive pulmonary disease. During record review on 3/14/23, it was noted that the physical therapy (PT) plan of care/re-evaluation on 2/28/23 was missing several components including pain assessment, vitals (on a patient with a high blood pressure diagnosis), range of motion (ROM), manual muscle testing (MMT), functional mobility, gait and balance. MR #5: This patient was admitted to home care with the diagnoses of heart disease, multiple sclerosis, peripheral vascular disease, left shoulder pain and hyoptension. During record review on 3/15/23, it was noted that the PT evaluation on 12/3/21 was missing several components including blood pressure (on a patient with a low blood pressure diagnosis), ROM, MMT, functional mobility and pain (with a left shoulder pain diagnosis). The PT re-certification dated 7/30/22 was missing upper extremity strength and all ROM measurements. Admin A acknowleged the findings during an interview on 3/17/23 at 11:12 a.m. MR#2: This patient was admitted to the agency on 3/01/22 with diagnoses of high blood pressure, cellulitis, and multiple sclerosis. The patient was recertified for 5 additional episodes of care from 3/01/22 through the date of discharge on 2/23/23. During record review on 3/14/23, it was noted that the physical therapy (PT) evaluation on 12/27/22 was blank of information in some of the following areas: vital signs, pain, sensory status, integumentary status, musculoskeletal, durable medical equipment, activities of daily living, functional independence/balance evaluation, fall risk, and rehabilitation potential. The plan of care for the 12/26/22 to 2/23/23 certification period ordered the PT to provide services twice weekly for 8 weeks. The PT visit notes indicate that only 1 PT visit was documented the week of 12/25/22. No PT visits were documented the week of 1/1/23. One PT visit note was documented the week of 1/8/23. For a total of 4 missed or missing visit notes. Also, it was noted that the last documented nursing visit note was dated 2/15/23. It was unclear what had happened with this patient after 2/15/23. There was no documentation of an updated comprehensive assessment of this patient to indicate the patient was discharged from the agency. During an interview on 3/14/23 at 3:30 p.m., the Administrator (Admin-A) was queried regarding the status of this patient. Admin-A explained that the patient was discharged on 2/23/23, but the nurse has been ill and has not turned in documentation of the updated assessment at discharge for this patient. It has been 19 days since the patient was discharged from the agency per Admin-A. The nurse and the physical therapist failed to follow the agency's policy titled, III.13 Clinical Record Contents and Maintenance (no date), which states that clinical notes should be written the day of the service delivery, signed, and incorporated into the record at least weekly. The findings were reviewed with and acknowledged by Admin-A during an interview on 3/17/23 at 9:30 a.m. MR#3: This patient was admitted to the agency on 9/26/20 with diagnoses of chronic obstructive pulmonary disease, high blood pressure, and atrial fibrillation. The 1/14/23 plan of care ordered physical therapy to provide twice weekly visits for 8 weeks. During record review on 3/15/23 it was noted that the last visit note for review was a missed visit note dated 11/22/22. The patient is a current active patient as of 3/16/23 when a joint survey home visit was conducted with Staff-B (PT). This totals 114 days of no documentation of PT clinical notes. The 1/13/23 physical therapy update of the comprehensive assessment for recertification was conducted and documented by Staff-B. During review of the updated assessment, it was noted that the following areas of the assessment were blank of information: musculoskeletal status, muscle strength against gravity, range of motion, balance/gait, transfers, endurance, joints, physical therapy interventions, fall risk, vital signs, pain rating and description, respiratory status, cardiac status, and the patient's ability to manage medications. The findings were reviewed with Admin-A during an interview on 3/16/23 at 11:10 a.m. Admin-A explained that he has been asking Staff-B for the notes every week, but they haven't been brought into the office. MR #6: The Start of Care (SOC) was dated 1/10/2023. The Plan of Care (POC) for the certification period 1/10/23 to 3/10/23 identified diagnoses of Chronic Obstructive Pulmonary Disease (COPD), Malignant Neoplasm of Upper Lobe Left Lung, Dependance on supplemental oxygen, Obstructive Sleep Apnea, and Low Back Pain. On 3/15/2023 a joint survey home visit was arranged for 2:30 p.m. with the physical therapist (Staff-B). A record review was completed before the time of the joint visit, and it was noted that there was no Physical Therapy Evaluation or Physical Therapy Care Plan found in the record. A request was made to the Administrator, (ADM-1) on 3/15/2022 at 9:30 am to provide a copy of the PT Evaluation and Care Plan to prepare for the scheduled Home Visit. The response was, "the agency Plan of Care for this patient is the PT Care Plan. There is no Care Plan specific for Physical Therapy. The agency failed to submit and provide a completed Physical Therapy Evaluation and a Physical Therapy Care Plan in the patient record. In addition, this patient was to receive physical therapy services 2xweekx8 weeks. A review of the PT visit notes revealed a note that was dated 2/8/23 with the date scribbled out and a new date of 1/17/23 was written over the 2/8/22 date. Upon further review of the PT visit notes it was noted there were missing visit notes as follows: Week 1: 1 PT visit note for SOC assessment dated 1/10/23, no further PT notes. Week 2: 1 altered PT note dated 1/17/23 changed from 2/8/23, no further notes. Week 3: 2 PT visit notes dated 1/23/23 and 1/25/23, no further PT visit notes. Week 4: 2 PT visit notes dated 1/30/23 and 2/1/23, no further PT visit notes. Week 5: 1 PT visit note dated 2/6/23 and no further PT visit notes because the note for 2/8/23 had been scribbled out and changed to 1/17/23. Week 6: 2 PT visit notes dated 2/13/23 and 2/15/23. No further PT visit notes. Week 7: 2 PT visit notes dated 2/20/23 and 2/22/23. No further PT visit notes. Week 8: 2 PT visit notes dated 2/27/23 and 3/1/23. No further PT visit notes. There were missing visit notes Weeks 1, 2, and week 5, however there was no documentation found in the record explaining if these visits were missed, or if the visit notes had not been submitted to the agency. Also, it was noted that the last PT visit note was dated 3/1/2023. The certification period was documented to end on 3/10/2023. There were no further visit notes or documentation after the 3/1/2023 PT visit note. There was no discharge summary, or documentation of the status of the patient after the 3/1/2023 PT visit leaving uncertainty of what had happened with the patient after 3/1/2023. These findings were reviewed and acknowledged by the Administrator (Admin-1) during an interview on 3/17/2023 at 1:00 p.m. Admin-1 stated, "I can't explain what happened with the missing visit notes."

Goals in the patient's plans of care CFR(s): 484.110(a)(3) Goals in the patient's plans of care and the patient's progress toward achieving them; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure that patient goals were specific and measurable in the patient's plan of care and that the patient's progress towards achieving these goals was documented in 2 of 7 records reviewed (MR #4, #5), resulting in an inability to accurately assess patient's status and need for continuing care. Findings include: MR #4: This patient was admitted to home care on 5/10/21 with the diagnoses of hypokalemia, urinary tract infection, kidney failure, high blood pressure, Parkinson's Disease and chronic obstructive pulmonary disease. During record review on 3/14/23, it was noted that the physical therapy re-evaluation and plan done by the physical therapist (Staff B) on 2/28/23 listed goals for manual muscle testing (MMT) to be at a grade of 4/5 and a Tinetti balance score to be 24/28. Upon further review of the re-evaluation, it was noted that the section for MMT was left blank and that there was no current Tinetti score recorded to determine the patient's current status and progress towards established goals. During an interview with the administrator (Admin A) on 3/17/23 at 11:00 a.m., he pointed to where that information should have been recorded on the form and acknowledged that it should have been filled out by Staff B. MR #5: This patient was admitted to home care on 12/2/21 with diagnoses of heart disease, multiple sclerosis, peripheral vascular disease, left shoulder pain and hypotension. During record review on 3/15/23, it was noted that the physical therapy evaluation on 12/2/21 listed goals for MMT to be at a grade of 4/5 and a Tinetti balance score to be 22/28. Upon further review of the evaluation, it was noted that the section for MMT was left blank and there was no baseline Tinetti score recorded to base the established goal on. During record review of the physical therapy re-certification dated 7/29/22, it was noted that MMT was marked as 4/5 throughout and the goal was still for MMT to be at a grade of 4/5 for lower extremity and no measurements for upper extremity, therefore being an inaccurate goal for the patient based on their current status. There was also a Tinetti score goal of 24/28 with no updated information on the patient's current score. Admin A acknowledged the findings during an interview on 3/17/23 at 11:15 a.m.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure a detailed discharge summary was sent to the physician within 5 business days of discharge for 2 of 2 (MR# 2, 5) discharge records reviewed, resulting in a lack of information to ensure continuity of care for the 11 patients discharged from the agency in the past 12 months. Findings include: MR#2: This patient was admitted to the agency on 3/01/22. During record review on 3/14/23, it was noted that the last documented nursing visit note was dated 2/15/23. During an interview on 3/14/23 at 3:30 p.m., the Administrator (Admin-A) was queried regarding the status of this patient. Admin-A explained that the patient was discharged on 2/23/23, but the nurse has been ill and has not turned in documentation of the updated assessment at discharge. It has been 19 days since the patient was discharged from the agency per Admin-A. There was no documented evidence that a detailed discharge summary was sent to the physician within 5 business days of discharge on 2/23/23. The agency failed to follow its own policy titled, III.11 Discharge Planning, Discharge Summary and Discharge OASIS (Outcome Assessment and Information Set) (no date), which states that professional staff are responsible for providing a written summary report for each patient and all discharge summaries shall be sent to the patient's physician within 5 days of the patient's discharge from services. MR #5: This patient was admitted to home care on 12/2/21 with the diagnoses of heart disease, multiple sclerosis, peripheral vascular disease, left shoulder pain and hypotension. During record review on 3/15/23, it was noted that the patient was discharged from agency services on 9/13/22 according to a communication note written by the administrator (Admin A) on that date. There was no documented evidence that a detailed discharge summary report was sent to the physician within 5 days of the patient's discharge. Admin A acknowledged the findings during an interview on 3/17/23 at 11:11 a.m.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure documents in the clinical records were legible, clear, complete, and appropriately authenticated with a signature and title, dated, and timed in 5 (MR#s 1, 3, 4, 5, 6) of 7 records reviewed, resulting in records that are not authenticated, accurate, timely, and do not portray the care provided by the agency. Findings include: MR #4: This patient was admitted to home care on 5/10/21 with the diagnoses of hypokalemia, urinary tract infection, kidney failure, high blood pressure, Parkinson's Disease and chronic obstructive pulmonary disease. During record review on 3/14/23, it was noted that The Outcome and Assessment Information Set (OASIS) completed on 2/24/23 was missing the signature and date of the person who completed it. During an interview with the administrator (Admin A) on 3/17/23 at 10:40 a.m., he stated that there is no signature on this form due to there not being a place for it. It was also noted that the physical therapy evaluation/plan of care completed on 2/28/23 was signed and dated by the physical therapist (Staff B) on the back of the last page, but it was missing several required signatures throughout the document, leaving it unclear as to who completed it. Admin A acknowledged the findings during an interview on 3/17/23 at 10:54 a.m. MR #5: This patient was admitted to home care on 12/2/21 with the diagnoses of heart disease, multiple sclerosis, peripheral vascular disease, left shoulder pain and hypotension. During record review on 3/15/23, it was noted that the physical therapy evaluation completed on 12/3/21 was signed and dated by Staff B on the back of the last page, but was missing several required signatures throughout the document, leaving it unclear as to who completed it. The administrator acknowledged the findings during an interview on 3/17/23 at 11:06 a.m. MR#1: This patient was admitted to the agency on 4/15/21 with diagnoses of chronic obstructive pulmonary disease, osteoarthritis, and knee pain. The patient was recertified for 10 additional episodes of care from 4/15/21 through the current date of record review on 3/14/23. The recertification assessment on 2/3/23 failed to be signed to indicate who had conducted the recertification assessment on this patient. The recertification assessment had a dedicated area for the physical therapist to sign and date the assessment. The signature area was blank. The findings were reviewed with and acknowledged by Admin-A during an interview on 3/17/23 at 9:30 a.m. MR#3: This patient was admitted to the agency on 9/26/20 with diagnoses of chronic obstructive pulmonary disease, high blood pressure, and atrial fibrillation. The patient was recertified for 14 additional episodes of care from 9/26/20 through the current date of a joint survey home visit with Staff-B (physical therapist) on 3/16/23. The patient receives physical therapy (PT) visits. During record review on 3/15/23, it was noted that the physical therapy recertification assessment dated 1/13/23 failed to be signed to indicate who had conducted the recertification assessment on this patient. The findings were reviewed with and acknowledged by Admin-A during an interview on 3/17/23 at 9:30 a.m. MR #6: The Start of Care (SOC) was dated 1/10/2023. The Plan of Care (POC) for the certification period 1/10/23 to 3/10/23 identified diagnoses of Chronic Obstructive Pulmonary Disease (COPD), Malignant Neoplasm of Upper Lobe Left Lung, Dependance on supplemental oxygen, Obstructive Sleep Apnea, and Low Back Pain. Upon review of the record, it was noted a FAX Transmission for the Physician Certification of Face-to-Face Encounter. The Face-to-Face Encounter was dated 7/06/2022 and signed by a physician Phy-1. It was noted the physician signature on the form was dated 2/21/23, 42 days after the Start of Care for this patient. In addition, a second page attached to the FAXED form was also a Physician Certification of a Face-to-Face Encounter. This form was signed 2/21/23 by the same physician, however the form was blank of any clinical information about the patient. Additionally, the Plan of Care for the certification period 1/10/23 to 3/10/23, was signed and dated by the nurse, however upon review of the record on 3/15/23, it was noted that the area for the signature and date of the attending physician was blank. The physician failed to authorize and authenticate the Plan of Care for this patient. Also, the orders documented on the comprehensive assessment included the physicians' signature, however, the area for the date was blank. In Addition, a verbal order for a re-certification of MR#6 to take effect on 3/11/23 was dated 3/6/2023 and initialed by a staff member, however the document did not have a physician signature or date. These findings were reviewed and acknowledged by the Administrator (Admin-A) during an interview on 3/17/2023 at 1:00 p.m.