Every finding on record at Direct Care Home Health Services LLC

The State Agency conducted an unannounced Federal Medicare/ Medicaid Home Health Agency Complaint Investigation Survey; Complaint # 105139 (Incident # 105140) from 03/01/2024 to 03/14/2024. On the first day of the survey, the Home Health Agency reported that their total active census was 141 patients, of which five (5) patients received skilled nursing services. Additionally, the agency reported their number of unduplicated admissions for skilled services, during the most recent 12-month period was six (6) patients. The surveyor found the Home Health Agency to be in substantial compliance with the requirements for the Emergency Preparedness Program. No deficiencies were cited.

The State Agency conducted an unannounced Federal Medicare/ Medicaid Home Health Agency Complaint Investigation Survey; Complaint # 105139 (Incident # 105140) from 03/01/2024 to 03/14/2024. On the first day of the survey, the Home Health Agency reported that their total active census was 141 patients, of which five (5) patients received skilled nursing services. Additionally, the agency reported their number of unduplicated admissions for skilled services, during the most recent 12-month period was six (6) patients. The sample size consisted of four (4) OASIS [(Outcome & Assessment Information Set) Validation Reports, 20 personnel records, five (5) clinical record reviews for patients receiving skilled services, and five (5) clinical record reviews for patients receiving Non-skilled services, of which three (3) were closed records for discharges. No Home Visits were conducted. The surveyor cited Standard Level deficiencies based on observations, interviews, review of clinical records, and the agency's policies. Additionally, the following condition level deficiencies were identified at 42 CFR: §484.45 Condition of participation: Reporting OASIS information. §484.55 Condition of participation: Comprehensive assessment of patients §484.60 Condition of participation: Care planning, coordination of services, and quality of care.

Reporting OASIS information CFR(s): 484.45 Condition of participation: HHAs must electronically report all OASIS data collected in accordance with §484.55. This CONDITION is not met as evidenced by: Based on review of clinical records, the agency’s policy, and interview with agency staff, the agency's clinical staff failed to electronically report all OASIS [(Outcome & Assessment Information Set) data collected for five (5) of five (5) beneficiaries receiving skilled nursing services, (Patients # 1, 2, 3, 4 and 5). Findings included... On 03/01/2024 at approximately 2:30 PM, the State Agency entered the Home Health Agency and requested for the Agency's OASIS (Outcome & Assessment Information Set) Validation Reports transmitted to CMS [Centers for Medicare and Medicaid Services] System. On 03/04/2024 at approximately 12:10 PM, the surveyor repeated the request for the agency’s OASIS Validation Reports. On 03/05/2024 at approximately 9:20 AM, Employee #1, the Administrator presented the surveyor with copies of OASIS Agency Final Validation Reports from iQIES (Internet Quality Improvement & Evaluation System) for four (4) patients. The reports showed a Submission Date/ Time: 03/04/2024 (Days after the commencement of the survey) at 9:20 AM, and Processing Completion dates/ Times: i. Patient #1- 03/04/2024 at 02:19:06 ii. Patient #2 -03/04/2024 at 02:19:17 iii. Patient #3 -03/04/2024 at 02:19:46 iv. Patient #5- 03/04/2024 at 06:23:21 In addition, a review of Patient #4’s clinical record showed a Start of Care Date of 06/09/2022 and a current Recertification Period from 01/30/2024 through 03/29/2024. The patient was admitted to the Home Health Agency for skilled nursing services including provision of Suprapubic Catheter and Wound care. The agency was unable to provide an OASIS Validation Report as proof of successful electronic OASIS assessment transmission for Patient #4. The surveyor conducted a face-to face interview with Employee #1 on 03/05/2024 at approximately 9:53 AM relevant to the OASIS Validation Reports. In response to the surveyor's query regarding validation reports for all patients receiving skilled services, Employee #1 reported that the agency experienced multiple challenges with their electronic medical records system for which they were in frequent communication by electronic mail. Employee # 1 acknowledged and confirmed the findings on 03/05/2024 at approximately 11:30 AM.

Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This STANDARD is not met as evidenced by: Based on interview with agency staff, and review of the CMS (Centers for Medicare and Medicaid Systems) iQIES (the Internet Quality Improvement and Evaluation System) Submission Report/ OASIS (Outcome and Assessment Information Set) Agency Final Validation Reports, the agency's staff consistently failed to electronically transmit completed OASIS assessments directly to the CMS system, within the timely guidelines of 30 days of completing each beneficiary’s assessments, for four (4) of four (4) submitted assessment records, for the time periods of 01/21/2023 through 10/20/2023. Findings include… The surveyor conducted a review of the Home Health Agency's OASIS Final Validation Reports on 03/07/2024 at approximately 1:30 PM. Review of the Home Health agency’s OASIS Final Validation Reports reflected the following: Patient #1 Eff Date 01/21/2023 transmitted 03/04/2024 > 30 days Patient #2 Eff Date 01/29/2024 transmitted 03/04/2024 > 30 days Patient #3 Eff Date 01/22/2024 transmitted 03/04/2024 > 30 days Patient #5 Eff Date 10/20/2023 transmitted 03/04/2024 > 30 days The Home Health Agency consistently failed to report OASIS data for patients admitted to the agency and receiving skilled services in a timely manner, as evidenced by the aforementioned OASIS Final Validation Reports. In addition, a review of Patient #4’s clinical record showed a Start of Care Date of 06/09/2022 and a current Recertification Period from 01/30/2024 through 03/29/2024. The patient was admitted to the Home Health Agency for skilled nursing services including provision of Suprapubic Catheter and Wound care. The agency was unable to provide an OASIS Validation Report as proof of successful electronic OASIS assessment transmission for Patient #4. Employees#1, the agency’s Administrator and #2, a Registered Nurse who is the agency’s Clinical Manager acknowledged and confirmed the findings during a face-to-face interview on 03/11/2024 at approximately 12:15 PM. On 03/13/2024 at approximately 11:00 AM, Employee #1 presented the surveyor with a note documented on the agency's letter head, which stated the agency inability to access OASIS Validation reports for the requested period of 06/01/2013 to 01/01/2024.

Accuracy of encoded OASIS data CFR(s): 484.45(b) Standard: The encoded OASIS data must accurately reflect the patient's status at the time of assessment. This STANDARD is not met as evidenced by: Based on review of clinical records, the agency’s policy, and interview with agency staff and the patient's caregiver, the agency's clinical staff failed to encode OASIS (Outcome and Assessment Information Set) data that accurately reflect the patient's status at the time of assessment for one (1) of ten (10) clinical records, (Patient #1). Findings included... The surveyor conducted an initial telephone interview with Patient #1’s Aunt who is the complainant on 03/01/2024 at approximately 5:15 PM. The complainant stated that Patient #1was always maintained in the home from birth until present day adulthood. She added that Patient #1 is totally dependent on someone else to provide her complete care including tube feeding and medication administration via a Gastrostomy tube. The complainant stated that the patient was blind and described her eyes as “buggy”. She further stated that although the patient is unaware, she tends to pop her own eyes out with her fingers from time to time. She stated that despite Patient #1’s current adult age, her functional and cognitive development is that of an infant. The surveyor conducted a review of Patient #1’s clinical record on 03/05/2024 at approximately 11:30 AM that showed Employee #5 prepared an OASIS (Outcome and Assessment Information Set)-E for Recertification dated 02/15/2023. The clinical record showed a Start of Care Date of 11/27/2023 and a Recertification period for a current Recertification Period from 02/16/2023 through 04/15/2024. Patient #1's admitting diagnosis included Epilepsy, Intellectual Disabilities, Bilateral Sensorineural Hearing Loss, Gastro-esophageal reflux disease without Esophagitis, Microcephaly, Encounter for attention to Gastrostomy, Cerebral Palsy, Chronic Obstructive Pulmonary Disease, Cytomegaloviral disease, Adolescent Idiopathic Scoliosis, and Intermittent Asthma. Additional review of the OASIS Assessment showed the following inconsistent and/or inaccurate information: i. Assessment item titled ‘Patient History & Diagnoses’ showed no patient history and reflected a blank area for ‘Last Physician Visit Date’; ii. Assessment item ‘GG0130 Self-Care’ that includes Eating; Oral Hygiene; and Toileting Hygiene showed the nurse coded the Performance Level of 01, for patient #1 who has been unable to attempt the activities due to medical condition from birth, according to the medical history provided by the legal representative; and iii. Assessment item ‘GG0170 Mobility’ that includes Roll Left and right; Sit to lying; Lying to sitting on side of bed; Sit to stand; Chair/bed-to-chair transfer; Toilet transfer; Walk 10 feet; Walk 50 feet with two turns; Walking 10 feet on uneven surfaces; The ability to go up and down a curb and/or up and down on the step; and the ability to go up and down four steps with or without a rail, showed the nurse coded the Performance Level of 01, for Patient #1 who has been unable to attempt the activities due to medical condition from birth, according to the medical history provided by the legal representative. According to the interview with the patient's caregiver, agency staff and review of the clinical record, Patient #1 could not attempt and could not perform these activities prior to the current illness, as a result of birth injury of greater than years. The clinical record lacked documented evidence that the findings of the OASIS Assessment was consistent with Patient #1’s current status of at the time the OASIS was completed. Employees#1, the agency’s Administrator and #2, a Registered Nurse who is the agency’s Clinical Manager acknowledged and confirmed the findings during a face-to-face interview on 03/06/2024 at approximately 12:15 PM.

Information to patient CFR(s): 484.50(a)(1) Provide the patient and the patient's legal representative (if any), the following information during the initial evaluation visit, in advance of furnishing care to the patient: This ELEMENT is not met as evidenced by: Based on interviews with agency staff and caregiver, review of clinical records and the agency's policy, the Home Health Agency failed to provide the patient’s caregiver the following information during the initial evaluation visit, in advance of furnishing care for one (1) of one (1) patient, (Patient #1). Findings included… A review of the Home Health Agency’s ‘Guidance’ titled “Home Care Patient Rights and Responsibilities” shows that as a Patient of the [Named] HHA, each patient has the right to be informed of their rights in writing, at the time of admission and before the initiation of care, and on an ongoing basis as necessary. The surveyor conducted an initial telephone interview with Patient #1’s Aunt who is the complainant on 03/01/2024 at approximately 5:15 PM. The complainant stated that Patient #1 was always maintained in the home from birth until present day adulthood. She added that Patient #1 is totally dependent on someone else to provide her complete care including tube feeding and medication administration via a Gastrostomy tube and requires skilled nursing services 24 hours per day and seven (7) days a week. During the telephone interview, the surveyor questioned the complainant regarding receipt of the following list of documents form the current [named Home Health Agency]. i. Advance Directive Information Form; ii. Overview of Admission/Start of Care Process; iii. Authorization/ Agreement for ; iv. Patient Consents and Authorizations; v. Release of Information; vi. HIPAA [Health Insurance Portability and Accountability Act] vii. Patient Consents And Authorizations Form; and viii. Authorization to Sign Timesheets for the [Named Patient] In response to the surveyor’s question regarding whether she signed documents relevant to the purpose of each service and when to expect the services provided by the agency, she stated that she did not recall, but and added there was no paperwork or any kind of documentation in the home from the current named Home Health Agency up to the time of our phone conversation on 03/01/2024 at approximately 6:10 PM. The surveyor conducted a review of Patient #1’s clinical record on 03/05/2024 at approximately 11:30 AM that showed Employee #5 prepared an OASIS (Outcome and Assessment Information Set)-E for Start of Care Date of 11/27/2023, an Initial Certification Period from 11/27/2023 through 01/25/2024. The surveyor conducted a face-to-face interview with Employees #1, the administrator, and #2 the Clinical Manager who acknowledged and confirmed the findings on 03/07/2024 at approximately 1:30 PM. The clinical record did not include signed copies of the aforementioned documents. Employee #1 provided the copies on 03/08/2024 at approximately 1:30 PM. The documents reflected the patient’s guardian signed them on 11/27/2024.

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 interviews with agency staff, review of clinical records and the agency's policy, the Home Health Agency failed to ensure the registered nurse conducted an effective initial assessment visit (G514); failed to provide comprehensive assessments that were complete; failed to document complete comprehensive assessment consistent with the patient's immediate needs, no later than five (5) calendar days after the start of care(G520); failed to document complete comprehensive assessment that reflects the patient’s health, psychosocial, functional, cognition (G528); failed to provide complete comprehensive assessments that reflected patients’ strengths, goals, care preferences, and information that may be used to demonstrate the patients’ progress toward achievement of goals identified by the patient and measurable outcomes identified by the agency; and failed review of all medications the patient was using 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 (G536). The cumulative effect of these systemic practices resulted in the Home Health Agency's failure to comply with conditions of participation for 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 review of clinical records, the agency's policy, and interview with agency staff and patient’s caregiver, the Home Health Agency failed to ensure the registered nurse conducted an effective initial assessment visit to determine the immediate care and support needs of the patient for one (1) of five (5) clinical records for patients receiving skilled services, (Patient #1). Findings included... A review of the Home Health Agency’s Patients’ Handbook titled “Skilled Admission Binder” shows that the patient requests for admission to the current [Named Agency] and consents to such care and treatment as is ordered by my attending physician. Additionally, the information reflects the patient understands that their care is directed and monitored by their attending physician. Further the information reflects that the current [Named Agency] is responsible for following their physician’s orders for home care. A review of the Home Health Agency’s policy number 10001, titled “Acceptance /Admission of Patients” shows that when a referral for care and/or services is received in the Home Health Agency, the information provided is evaluated by the supervisor, or designee, to ensure that the patient and the care/services requested meet the standards set forth by the Agency. Additionally, the policy shows that in the event that it is determined that the agency cannot reasonably accommodate the patient’s needs, or the patient does not meet the admission criteria, the patient, family, and referral source will be notified and provided with information about other providers. The surveyor conducted an initial telephone interview with Patient #1’s Aunt who is the complainant on 03/01/2024 at approximately 5:15 PM. The complainant stated that Patient #1was always maintained in the home from birth until present day adulthood. She added that Patient #1 is totally dependent on someone else to provide her complete care including tube feeding and medication administration via a Gastrostomy tube. The complainant stated that the patient was blind and described her eyes as “buggy”. She further stated that although the patient is unaware, she tends to pop her own eyes out with her fingers from time to time. She stated that despite Patient #1’s current adult age, her functional and cognitive development is that of an infant. The surveyor conducted a face-to-face interview with Employee #4, RN (Registered Nurse)/ former acting Clinical Manager at the time of Patient #1’s admission, regarding the agency’s intake process for accepting new patients. Employee #4 stated that the current [Named Home Health Agency] received a referral from the state’s Medicaid health plan requesting for Patient #1 to be transferred from the former [Home Health Agency] that provided skilled nursing care for greater than 20 years, to the current [Named Agency]. In turn, an RN was assigned to schedule an agreeable date and time with the patient’s guardian to conduct an initial assessment visit to determine the immediate care and support needs of the patient. Employee #4 added that the only documentation that the current [Named Agency] received relative to processing the transfer, was the most recent Comprehensive Assessment and Plan of Care from the former Home Health Agency. She also stated that was all that was provided and these were the documents that were used to process the admission process for Patient #1. The surveyor conducted a review of Patient #1’s clinical record on 03/04/2024 at approximately 11:30 AM that contained a copy of from the former [Home Health Agency] that showed a Start of Care date of 11/15/2010, and a Recertification Period from 03/11/2013 through 05/09/2023. In addition, Patient #1’s clinical record showed a Start of Care Date of 11/27/2023, and a current Recertification Period from 02/16/2023 through 04/15/2024. The patient's admitting diagnosis included Epilepsy, Intellectual Disabilities, Bilateral Sensorineural Hearing Loss, Gastro-esophageal Reflux Disease, Microcephaly, Encounter for attention to Gastrostomy, Cerebral Palsy, Chronic Obstructive Pulmonary Disease, Cytomegaloviral Disease, Adolescent Idiopathic Scoliosis, and Intermittent Asthma. All of the aforementioned admitting diagnoses on the Plan of Care reflected the date of onset as 11/27/2023; same as the Start of Care date. The physician’s orders on the original Plan of Care included Skilled Nursing services for 24 hours each day, and seven (7) days a week. A review of Patient #1’s electronic health record for documentation of skilled nursing services provided in the home revealed that the home health agency was unable to provide the patient with 24 hours each day, and seven (7) days a week as per the plan of care. Continued review of the clinical record lacked documented evidence that the current [Named Agency] conducted the initial assessment visit effectively in order to determine all items including medications, mobility aids for safety, skilled nursing treatments, nutritional needs, the number of skilled nursing hours and services that would be necessary to maintain the patient’s health and safety until the new Comprehensive Assessment and Plan of Care could be completed. Further, the clinical record lacked documented evidence that the current [Named Agency] contacted Patient #1’s ordering physician to ensure compliance with specific current orders. Employee #2 acknowledged and confirmed the findings during the face-to-face interview on 03/04/2024 at approximately 3:20 PM. Cross Reference G0520; G0528; and G0536.

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on review of clinical records, the agency's policy, and interview with agency staff and caregiver, the Home Health Agency failed to document a complete comprehensive assessment consistent with the patient's immediate needs, no later than five (5) calendar days after the start of care for one (1) of five (5) clinical records, (Patient #1). Findings included... A review of the Home Health Agency’s policy titled “Completion of the Comprehensive Assessment” showed that each comprehensive assessment must be completed in its entirety. The surveyor conducted an initial telephone interview with Patient #1’s Aunt who is the complainant on 03/01/2024 at approximately 5:15 PM. The complainant stated that Patient #1was always maintained in the home from birth until present day adulthood. She added that Patient #1 is totally dependent on someone else to provide her complete care including tube feeding and medication administration via a Gastrostomy tube. The complainant stated that the patient was bling and described them as buggy. She further stated that although the patient is unaware, she tends to pop her own eyes out with her fingers from time to time. She stated that the patient is caught up with all of the required immunizations. The surveyor conducted a review of Patient #1’s clinical record on 03/04/2024 at approximately 11:30 AM that showed a Start of Care Date of 11/27/2023, and a current Recertification Period from 02/16/2023 through 04/15/2024. The patient's admitting diagnosis included Epilepsy, Intellectual Disabilities, Bilateral Sensorineural Hearing Loss, Gastro-esophageal Reflux Disease, Microcephaly, Encounter for attention to Gastrostomy, Cerebral Palsy, Chronic Obstructive Pulmonary Disease, Cytomegaloviral Disease, Adolescent Idiopathic Scoliosis, and Intermittent Asthma. The physician’s orders on the original Plan of Care included Skilled Nursing services for 24 hours each day, and seven (7) days a week. In addition, the clinical record showed Employee #5, a Registered Nurse completed an OASIS-E comprehensive assessment for ‘Recertification’ and dated 02/15/2024. A review of the assessment showed the following incomplete and inappropriate information: i. Assessment item titled ‘Patient History & Diagnoses’ showed a blank space for the date of the ‘Last Physician Visit’; ii. Assessment item titled ‘Immunizations’ showed 3 named immunizations followed by “Contraindicated” with no other comments; iii. Assessment item titled ‘Names of organizations providing assistance’ showed a blank space; iv. Assessment item titled ‘Sensory Status’ showed a blank space for ‘Last Eye Exam Date’; v. Assessment item titled ‘Respiratory Goals’ showed the following entries; a. Pt will have adequate working knowledge of disease process, patho [pathophysiology], and exacerbation within 60 days. b. Pt will be able to list 3 of 5 signs and symptoms of COPD [Chronic obstructive pulmonary disease], within 60 days. Pt will be able to list 2 of 4 uses of medication within 60 days; and c. Nurse to teach client/caregiver how to use inhaler for shortness of breath. vi. Assessment item titled ‘Measures to Prevent Asthma’ included “…Eat a well-balanced diet. Drink 2 to 3 quarts of fluid each day to liquefy secretions. Use stress-management techniques. Exercise daily, avoiding overexertion. Avoid exercise in cold temperatures. Obtain allergy shots as recommended. Review of the clinical record showed Patient #1 is on a prescribed enteral nourishment via feeding tube and prescribed nothing by mouth. vii. Assessment item titled ‘Cardiac Status Goals’ showed the nurse selected “Client will remain free from chest pain, or chest pain will be relieved with nitroglycerin, during the care period. Review of the clinical record did not include prescribed Nitroglycerin medication. viii. Assessment item titled ‘Nutritional Health Screen’ showed the nurse selected d. Eats alone most of the time; and e. Not always physically able to cook/feed self and no CG[Caregiver] to assist for a patient receiving enteral tube feed via gastric tube. Employee #2 acknowledged and confirmed the findings 03/12/2024 at approximately 12:20 PM. Cross Reference G0514; G0528; and G0536

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 review of clinical records, the agency's policy, and interview with the agency’s staff and caregiver, the Home Health Agency failed to provide a complete comprehensive assessment that accurately reflected the patient's status for one (1) of five (5) clinical records, for patients receiving skilled services, (Patient #1). Findings included... A review of the Home Health Agency’s policy titled “Completion of the Comprehensive Assessment”, showed that the comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum the patient's strengths, goals, and care preferences, including information that may be used to demonstrate the patient's progress toward achievement of the goals identified by the patient and the measurable outcomes identified by the Agency. The surveyor conducted an initial telephone interview with Patient #1’s Aunt who is the complainant on 03/01/2024 at approximately 5:15 PM. The complainant stated that Patient #1was always maintained in the home from birth until present day adulthood. She added that Patient #1 is totally dependent on someone else to provide her complete care including tube feeding and medication administration via a Gastrostomy tube. The complainant stated that the patient was blind and described her eyes as “buggy”. She further stated that although the patient is unaware, she tends to pop her own eyes out with her fingers from time to time. She stated that despite Patient #1’s current adult age, her functional and cognitive development is that of an infant. The surveyor conducted a review of Patient #1’s clinical record on 03/04/2024 at approximately 11:30 AM that showed a Start of Care Date of 11/27/2023, and a current Recertification Period from 02/16/2023 through 04/15/2024. The patient's admitting diagnosis included Epilepsy, Intellectual Disabilities, Bilateral Sensorineural Hearing Loss, Gastro-esophageal Reflux Disease, Microcephaly, Encounter for attention to Gastrostomy, Cerebral Palsy, Chronic Obstructive Pulmonary Disease, Cytomegaloviral Disease, Adolescent Idiopathic Scoliosis, and Intermittent Asthma. The physician’s orders on the original Plan of Care included Skilled Nursing services for 24 hours each day, and seven (7) days a week. In addition, the clinical record showed Employee #5, a Registered Nurse completed an OASIS-E comprehensive assessment for ‘Recertification’ and dated 02/15/2024. The comprehensive assessment did not provide a picture of the patient’s status to assist the agency in developing the Plan of Care. The assessment did not contain the patient’s psychosocial status, her functional capacity, current health status including relevant past medical history as well as all active health and medical problems and did not reflect the patient's status accurately. The surveyor conducted a face-to-face interview with Employee #2, a Registered Nurse and the agency’s Clinical Manager who acknowledged and confirmed the findings on 03/12/2024 at approximately 12:10 PM. Cross Reference: G0514; G0520; and G0536

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 interview with agency staff and caregiver, review of clinical records and the agency's policy, the Home Health Agency failed to review of all medications the patient was using 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 for one (1) of ten (10) clinical records, (Patient #1). Findings included... A review of the Home Health Agency's policy, titled, "Medication Reconciliation", showed that the RN (Registered Nurse) will review all medications at the time of admission to the home care agency, and will document a complete list of mediations taken by the patient. In addition, the Clinical Manager reminds all RNs that any discrepancies in the medication review process must be communicated to the patient's medical provider for resolution, must be documented on the comprehensive assessment and RN visit note. The surveyor conducted an initial telephone interview with Patient #1’s Aunt who is the complainant on 03/01/2024 at approximately 5:15 PM. The complainant stated that Patient #1was always maintained in the home from birth until present day adulthood. She stated that Patient #1 was born at a local hospital and from birth, the hospital trained the family on aspects on how to care for her in the home. She added that Patient #1 is totally dependent on someone else to provide her complete care including tube feeding and medication administration via a Gastrostomy tube. The complainant stated that the patient was blind and described the outward appearance of her eyes as buggy. She further stated that although the patient is unaware, she tends to pop her own eyes out with her fingers from time to time. The complainant further verbalized concerns regarding the management of the large number of prescribed medications that Patient #1 is required to have administered by someone else each day, via a Gastrostomy tube. She further stated that although Patient #1’s family is well versed in in everything that is required for Patient #1’s needs, they do need the skilled nursing services 24/7 and they would willingly fill in on shifts for which there were no skilled nurse available. The surveyor conducted a review of Patient #1’s clinical record on 03/04/2024 at approximately 11:30 AM that showed an outside medical clinic report for a discharge follow-up Telehealth visit dated 11/06/2023. The report showed Patient #1 was recently hospitalized from 10/10/2023 to 10/27/2023 for treatment of sepsis due to Left Lower Lobe Pneumonia. The report also reflected the following diagnoses: Aspiration, Chronic Pulmonary Bilateral Wheezing; Cavitary Lung Disease Secondary to Chronic Aspiration; Morbid Obesity; Blindness; Scoliosis, and Wheelchair Dependence. Additional review of Patient #1’s clinical record contained a copy of the Plan of Care from the former [Home Health Agency] that showed a Start of Care date of 11/15/2010, and a Recertification Period from 03/11/2013 through 05/09/2023. Further, the clinical record showed a Start of Care Date of 11/27/2023, and a current Recertification Period from 02/16/2023 through 04/15/2024 with the current agency. The patient's admitting complex diagnosis included Epilepsy, Intellectual Disabilities, Bilateral Sensorineural Hearing Loss, Gastro-esophageal Reflux Disease, Microcephaly, Encounter for attention to Gastrostomy, Cerebral Palsy, Chronic Obstructive Pulmonary Disease, Cytomegaloviral Disease, Adolescent Idiopathic Scoliosis, and Intermittent Asthma. Also, review of the clinical record showed Employee#5, a registered nurse prepared an OASIS (Outcome and Assessment Information Set) -E assessment for Recertification dated 02/15/2024. The listing of medications was not included as a part of the comprehensive assessment. A review of the Plan of Care item titled ‘Medications’; Dose/Frequency/Route detailed a listing of 25 different prescribed medications which included incomplete orders: 1) ATIVAN 3 MG (milligram)/1.5 (milliliter) Frequency:1.5 ML every night at bedtime, via feeding tube; NO INDICATION 2) CARNITOR 100 milligram /ML ORAL SOLUTION Frequency: 2 milliliter three times daily, via feeding tube; NO INDICATION 3) DANTRIUM 12.5 MG Frequency: 2.5ml twice daily, via feeding tube; NO INDICATION 4) DEPAKOTE 250 MG/5 ML; Frequency:10 ml three times daily, via feeding tube 5) DIAMOX 125 MG ORAL TABLET Frequency:2 tabs twice daily, via feeding tube; 1st three days of menses when seizures increase NO INDICATION 6) FLONASE 50 MCG (micrograms)/INH NASAL SPRAY, one spray each nostril twice daily; NO INDICATION 7) KLONOPIN 0.1 MG/ML Frequency: 5ml every 8am and 4pm, via feeding tube, NO INDICATION 8) KLONOPIN 0.1 MG/ML Frequency: 6ml at midnight, feeding tube, NO INDICATION 9) PREVACID SOLUTAB 15 MG ORAL TABLET, DISINTEGRATING, 15mg every night via feeding tube NO INDICATION 10) REFRESH LIQUIGEL one gtt (Drop)each eye six times daily, drops, gel or ointment for the eye NO INDICATION 11) SINGULAIR 5 MG ORAL TABLET, CHEWABLE, every nite at bedtime via feeding tube NO INDICATION 12) SYSTANE FREE OPHTHALMIC GEL, three times daily, drops, gel or ointment for the eye, apply small amount to both eyes NO INDICATION 13) TOPAMAX 225MG, twice daily via feeding tube; NO INDICATION 14) ZYRTEC 10ml daily, via feeding tube; NO INDICATION i. The aforementioned prescribed medications did not include an indication of reason for each. 15) HIBICLENS 40% (Percent) TOPICAL SOAP; 2-3 times weekly. Apply standard amount leave on for 5 minutes before bath then rinse NO INDICATION/ NO Affected area ii. The medication prescribed for Topical application did not include an indication, or identified anatomical affected area, the specific affected area for application. FLINTSTONES MVI, daily via feeding tube included NO DOSAGE iii. The multivitamin did not include a prescribed dosage. 16) TYLENOL 650MG SUPPOSITORY,1 suppository every 4 hours as needed per rectum; NO INDICATION 17) ATROVENT Frequency:1 vial every 6 hours as needed… Route hand held nebulizer (HHN) 18) HYDROCORTISONE 25% TOPICAL OINTMENT, as needed; apply liberally, to WHAT AFFECTED AREA 19) GUAIFENESIN 100 MG/5 ML ORAL LIQUID; Frequency:400 mg twice daily as needed; via feeding tube iv. Medications that were prescribed to be administered “as needed” did not include directives on how to determine when to administer each. The list did not include 'an indication for administration' for each prescribed medication or what is the drug used to treat, and an identified anatomical affected area for application of the topical medications. The physician’s orders on the Plan of Care directed Skilled Nursing services for 24 hours each day, and seven (7) days a week. The clinical record lacked documented evidence that Patient #1's physician was contacted to clarify and/or verify the medications, obtain orders, and record all patient care orders in the plan of care. The surveyor conducted a face-to-face interview with Employees #1, the administrator, and #2 the Clinical Manager who acknowledged and confirmed the findings on 03/07/2024 at approximately 1:30 PM. Cross Reference: G0514; G0520; and G0528.

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 interviews with agency staff and caregiver, review of clinical records and the agency's policy, the Home Health Agency failed to ensure that each individualized plan of care included all required elements (G574), failed to follow the physician’s orders for frequency and duration of skilled nursing services in accordance with the plan of care (G580); and failed to coordinate care delivery to meet the patient’s needs (G608). The cumulative effect of these systemic practices resulted in the Home Health Agency's failure to comply with conditions of participation for Care planning, coordination of services, and 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 review of clinical records, the agency's policy, and interview with agency staff and patient’s caregiver, the agency's staff failed to ensure that the patient's Plan of Care was individualized and included all required elements, for one (1) of five (5) clinical records for patients receiving skilled services, (Patient #1). Findings included... A review of the Provider Manual: Appendix 5, Reporting and Assessment Forms/ Home Health Certification and Plan of Care Instructions titled “Completion of Form CMS [Centers for Medicaid and Medicare]-485, Home Health Certification and Plan of Care” shows that the ‘Form CMS-485’ meets the regulatory requirements (State and Federal) for both the physician's home health plan of care and home health certification and recertification requirements. The manual directs completion of item 11. ‘Principal Diagnosis’ may change on subsequent forms only if the patient develops an acute condition or an exacerbation of a secondary diagnosis requiring intensive services different than those on the established plan of care...The date is always represented by six digits (MMDDYY); if the exact date is not known, use 00. The date of onset is specific to the reason for home health services. If a condition is chronic or long term in nature, use the date of exacerbation. Use one or the other, not both..." Additionally, The Provider Manual: Appendix 5, Reporting and Assessment Forms/ Home Health Certification and Plan of Care Instructions titled 'Completion of Form CMS--485', Home Health Certification and Plan of Care directs for completion of item number 21 on the Plan of care, "Orders for Discipline and Treatments...The physician must specify the frequency and expected duration of the visits for each discipline...PRN [as needed] visits may be ordered on a plan of care only where they are qualified in a manner that is specific to the patient's potential needs. Both the nature of the services and the number of PRN visits to be permitted for each type of service must be specified. Open-ended, unqualified PRN visits do not constitute physician orders since their nature nor their frequency is specified..." A review of the Home Health Agency’s policy number 10004, titled Plan of Care, and revised 01/01/2018 showed the Plan of Care shall include but not limited to the Physician Orders for Skilled Services, Physical Assessment including all pertinent diagnoses, Prognosis including rehabilitation potential; Information relating to any advance directives, and so on. Additionally, a review of the Home Health Agency’s “Guidance for the registered nurse to conduct effective initial assessment visits to determine the immediate care and support needs of the patient” showed that the RN will review all incoming referral documents at the time of referral: including the discharge documents, clinical encounter documents, laboratory data, medication records, and treatment records. The surveyor conducted an initial telephone interview with Patient #1’s Aunt who is the complainant on 03/01/2024 at approximately 5:15 PM. The complainant stated that Patient #1was always maintained in the home from birth until present day adulthood. She stated that Patient #1 was born at a local hospital and from birth, the hospital trained the family on aspects on how to care for her in the home. She added that Patient #1 is totally dependent on someone else to provide her complete care including tube feeding and medication administration via a Gastrostomy tube. The complainant stated that the patient was blind and described the outward appearance of her eyes as buggy. She further stated that although the patient is unaware, she tends to pop her own eyes out with her fingers from time to time. The complainant further verbalized concerns regarding the management of the large number of prescribed medications that Patient #1 is required to have administered by someone else, via a Gastrostomy tube. She further stated that although Patient #1’s family is well versed in in everything that is required for Patient #1’s needs, they do need the skilled nursing services 24/7 and they would willingly fill in on shifts for which there were no skilled nurse available. The surveyor conducted a review of Patient #1’s clinical record on 03/04/2024 at approximately 11:30 AM that showed an outside medical clinic report for a discharge follow-up Telehealth visit dated 11/06/2023. The report showed Patient #1 was recently hospitalized from 10/10/2023 to 10/27/2023 for treatment of sepsis due to Left Lower Lobe Pneumonia. The report also reflected the following diagnoses: Aspiration, Chronic Pulmonary Bilateral Wheezing; Cavitary Lung Disease Secondary to Chronic Aspiration; Morbid Obesity; Blindness; Scoliosis, and Wheelchair Dependence. Additional review of Patient #1’s clinical record showed a Plan of Care with a Start of Care date of 11/27/2023, and an Initial Certification Period from 11/27/2023 through 01/25/2024. The clinical record also included a current Plan of Care with a recertification period from 02/16/2024 through 04/15/2024. The patient's admitting diagnosis included Epilepsy, Intellectual Disabilities, Bilateral Sensorineural Hearing Loss, Gastro-esophageal reflux disease without Esophagitis, Microcephaly, Encounter for attention to Gastrostomy, Cerebral Palsy, Chronic Obstructive Pulmonary Disease, Cytomegaloviral Disease, Adolescent Idiopathic Scoliosis, and Intermittent Asthma. All of the aforementioned diagnoses on the Plan of Care reflected the date of onset as 11/27/2023, same as the Start of Care date. Further review of the Plan of Care showed the following incomplete and/or inaccurate items: i. The Plan of Care did not include all known diagnoses. ii. Plan of Care item titled ‘Advanced Directives’ showed “No Advanced Directives” iii. Plan of Care item titled ‘Caregiver Status’ showed two names and corresponding telephone numbers, and did not identify the Patient #1’s caregiver iv. Plan of Care item titled ‘Psychosocial Status’ showed “No Problem Identified” v. Plan of Care item titled ‘Emergency Preparedness’ showed Emergency Triage: #2 followed by “…Not life threatening but would suffer severe adverse effects from interruption of services (i.e., daily insulin, IV…) and did not detail individualized information, specific for Patient #1 that would reflect the complexity of care needed. vi. Plan of Care item titled ‘Medications’ Dose/Frequency/Route detailed a listing of 25 different medications contained the following prescribed medications which included incomplete orders for the following: a. Prescribed medications did not include 'an indication for administration' for each prescribed medication; b. Medications prescribed for “Topical” application did not include an indication, or identified anatomical affected area, the specific affected area for application; c. The multivitamin did not include a prescribed dosage; and d. Medications that were prescribed to be administered “as needed” did not include directives on how to determine when to administer each. vii. The ‘Durable Medical Equipment and Supplies’ reflected a PEG (percutaneous endoscopic gastrostomy), but did not include who to call, what to do in the event of accidental dislodging, the amount of sterile water used inflate the balloon viii. Plan of Care item ‘Nutritional Requirements’ reflected “Enteral Nutrition boost (formula) 75 ml/hr per PEG and via Pump. Further on the Plan of Care showed “Boost High Protein 75 ml bolus at 10am; Boost High Protein 75ml bolus at 12noon, Boost High Protein 75ml bolus at 4pm; and Boost High Protein 75cc/hr. from 8pm-8am; followed by Pedialyte 480ml bolus. ix. Plan of Care item titled ‘Orders for Discipline and Treatments (Specify Amount, Frequency and Duration)’ directed Skilled Nursing services for 24 hours each day, and seven (7) days a week times 60 days to manage total care needs, to observe the patient’s progress, and to evaluate the need for changes in the treatment plan. Skilled care is necessary to ensure maintenance of her overall health monitor for upper airway obstruction, facilitate support, nutritional status assist, administer and monitor intake, including medication and hydration. Patient is reliant on g-tube for all feedings and medication administration. The surveyor conducted a face-to-face interview with Employees #1, the agency’s Administrator and #2, a Registered Nurse who is the agency’s current Clinical Manager. They both acknowledged and confirmed the findings following the review of the Plan of Care on 03/06/2024 at approximately 3:15 PM.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on interviews with agency staff and caregiver, review of clinical records and the agency's policy, the Home Health Agency failed to follow the physician’s for frequency and duration of skilled nursing services in accordance with the plan of care for one (1) patient, (Patient #1). Findings included… A review of the Home Health Agency’s unnumbered policy, titled “Missed Visit Skilled Nursing Coverage Policy” shows that the staffing coordinator shall schedule staff who have the appropriate and required training for the person receiving services. Back up staff who are trained shall be identified for each person receiving services. Additionally, the policy states that in the event backup staff is unable to provide services for any reason, the previously identified family member(s) competent and knowledgeable in providing care shall be utilized to provide continuity of care. If the identified family member is unable or unwilling to provide services for any reason, the staffing coordinator, nursing supervisor or Program Manager will make all necessary arrangements to transfer the patient to the hospital. The surveyor conducted an initial telephone interview with Patient #1’s Aunt who is the complainant on 03/01/2024 at approximately 5:15 PM. The complainant stated that Patient #1was always maintained in the home from birth until present day adulthood. She stated that Patient #1 was born at a local hospital and from birth, the hospital trained the family on aspects on how to care for her in the home. She added that Patient #1 is totally dependent on someone else to provide her complete care including tube feeding and medication administration via a Gastrostomy tube. The complainant stated that the patient was blind and described the outward appearance of her eyes as buggy. She further stated that although the patient is unaware, she tends to pop her own eyes out with her fingers from time to time. The complainant further verbalized concerns regarding the management of the large number of prescribed medications that Patient #1 is required to have administered by someone else, via a Gastrostomy tube. She further stated that although Patient #1’s family is well versed in in everything that is required for Patient #1’s needs, they do need the skilled nursing services 24/7 and they would willingly fill in on shifts for which there were no skilled nurse available. The surveyor conducted a review of Patient #1’s clinical record on 03/04/2024 at approximately 11:30 AM that showed a Start of Care Date of 11/27/2023, and a current Recertification Period from 02/16/2023 through 04/15/2024. The patient's diagnoses on the Plan of Care included Epilepsy, Intellectual Disabilities, Bilateral Sensorineural Hearing Loss, Gastro-esophageal Reflux Disease, Microcephaly, Encounter for attention to Gastrostomy, Cerebral Palsy, Chronic Obstructive Pulmonary Disease, Cytomegaloviral Disease, Adolescent Idiopathic Scoliosis, and Intermittent Asthma. The physician’s orders on the original Plan of Care included Skilled Nursing services for 24 hours each day, and seven (7) days a week. On 03/07/2024, the surveyor conducted additional review of Patient #1’s electronic health record for documentation of skilled nursing services provided in the home. The clinical record revealed the Home Health Agency did not provide 24 hours skilled nursing services, or partial tours of duty on the following dates: i. February 14, 15, 18, 21,23,24,25, 26, 27, 28, and 29, 2024; ii. March 1, 2, 4, 5, 6, 7, 8, 9, 11, 12, 13, and 2024. the surveyor Exited the on-site investigation at the facility on March 14, 2024 The Home Health Agency failed to ensure the provision of skilled nursing services in accordance with the plan of care for Patient #1, as evidenced by the absence of skilled nursing documentation that addressed the provision of the afore-stated orders for skilled nursing services.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on review of clinical records, the agency's policy, and interview with the agency’s staff and caregiver, the Home Health Agency failed to coordinate care delivery to meet the patient’s needs for one (1) of five (5) clinical records, for patients receiving skilled services, (Patient #1). Findings included... The surveyor conducted an initial telephone interview with Patient #1’s Aunt who is the complainant on 03/01/2024 at approximately 5:15 PM. The complainant stated that Patient #1was always maintained in the home from birth until present day adulthood. She added that Patient #1 is totally dependent on someone else to provide her complete care including tube feeding and medication administration via a Gastrostomy tube. The complainant stated that the patient was blind and described her eyes as “buggy”. She further stated that although the patient is unaware, she tends to pop her own eyes out with her fingers from time to time. She stated that despite Patient #1’s current adult age, her functional and cognitive development is that of an infant. The surveyor conducted a review of Patient #1’s clinical record on 03/04/2024 at approximately 11:30 AM that showed a Start of Care Date of 11/27/2023, and a current Recertification Period from 02/16/2023 through 04/15/2024. The patient's admitting diagnosis included Epilepsy, Intellectual Disabilities, Bilateral Sensorineural Hearing Loss, Gastro-esophageal Reflux Disease, Microcephaly, Encounter for attention to Gastrostomy, Cerebral Palsy, Chronic Obstructive Pulmonary Disease, Cytomegaloviral Disease, Adolescent Idiopathic Scoliosis, and Intermittent Asthma. The physician’s orders on the original Plan of Care included Skilled Nursing services for 24 hours each day, and seven (7) days a week. The clinical record lacked documented evidence of consistent ongoing communication between the patient’s representative, caregiver(s), the patient’s physicians, registered nurses and the various assigned skilled LPNs (Licensed Practical Nurses) providing care in the home.

Responsibilities of skilled professionals CFR(s): 484.75(b) Standard: Responsibilities of skilled professionals. Skilled professionals must assume responsibility for, but not be restricted to, the following: This STANDARD is not met as evidenced by: Based on review of clinical records, the agency's policy, and interview with agency staff, the Home Health Agency failed to maintain complete and accurate records reflecting the specific skilled nursing services provided as evidenced by failure to ensure the LPN (Licensed Practical Nurse) recorded clinical notes for one (1) of five (5) clinical records for patients receiving skilled services, (Patient #1). Findings included... The surveyor conducted an initial telephone interview with Patient #1’s Aunt who is the complainant on 03/01/2024 at approximately 5:15 PM. The complainant stated that Patient #1was always maintained in the home from birth until present day adulthood. She stated that Patient #1 was born at a local hospital and from birth, the hospital trained the family on aspects on how to care for her in the home. She added that Patient #1 is totally dependent on someone else to provide her complete care including tube feeding and medication administration via a Gastrostomy tube. The complainant stated that the patient was blind and described the outward appearance of her eyes as buggy. She further stated that although the patient is unaware, she tends to pop her own eyes out with her fingers from time to time. The complainant further verbalized concerns regarding the management of the large number of prescribed medications that Patient #1 is required to have administered by someone else, via a Gastrostomy tube. She further stated that although Patient #1’s family is well versed in in everything that is required for Patient #1’s needs, they do need the skilled nursing services 24/7 and they would willingly fill in on shifts for which there were no skilled nurse available. The surveyor conducted a review of Patient #1’s clinical record on 03/04/2024 at approximately 11:30 AM that showed a Start of Care Date of 11/27/2023, and a current Recertification Period from 02/16/2023 through 04/15/2024. The patient's admitting diagnosis included Epilepsy, Intellectual Disabilities, Bilateral Sensorineural Hearing Loss, Gastro-esophageal Reflux Disease, Microcephaly, Encounter for attention to Gastrostomy, Cerebral Palsy, Chronic Obstructive Pulmonary Disease, Cytomegaloviral Disease, Adolescent Idiopathic Scoliosis, and Intermittent Asthma. All of the aforementioned admitting diagnoses on the Plan of Care reflected the date of onset as 11/27/2023; same as the Start of Care date. The physician’s orders on the original Plan of Care directed Skilled Nursing services for 24 hours each day, and seven (7) days a week. On 03/07/2024, the surveyor conducted additional review of Patient #1’s electronic health record for documentation of skilled nursing services provided in the home revealed that Employee #10, LPN (Licensed Practical Nurse) provided Private Duty Nursing services for the following timeframe for approximately 75 shifts, a combination of eight (8) hour; 12 hour; 14 hour; and 16-hour shifts from 11/30/2023 through 03/03/2024. Upon the surveyor’s attempt to open each document to review the contents of the respective ‘LPN Shift Note’(s), the surveyor observed there were no note entries for each date and time that Employee #10 provided Patient #1 with Private Duty Nursing services, for approximately 75 shifts, a combination of eight (8) hour; 12 hour; 14 hour; and 16-hour shifts from 11/30/2023 through 03/03/2024. The absence of nursing notes for the aforementioned shifts could not ensure that Patient #1 received skilled nursing services as ordered by the provider to meet the patient’s needs in the home. The surveyor conducted a face-to-face interview with Employees #1, the agency’s Administrator and #2, a Registered Nurse who is the agency’s current Clinical Manager. They both acknowledged and confirmed the findings on 03/07/2024 at approximately 11:10 AM.

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on review of clinical records, policy review, and interview with agency staff, agency staff failed to provide services in accordance with current clinical practice guidelines and accepted professional standards of practice in one (1) of 10 clinical records (Patient # 8). Findings include... A review of the Home Health Agency’s clinical guidance titled “Patient documentation parameters for the RN (Registered Nurse) for the hemodialysis patient receiving home health services” shows that the nurse will document the type and location of the dialysis access and enter alerts on the clinical record not to obtain blood pressure measurements, draw blood samples or administer medications by injections on that affected extremity, The surveyor conducted a review of Patient#8’s clinical record on 03/12/2024 at approximately 1:30 PM that showed a Plan of Care for Personal Care Aide Services with a Start of Care date of 10/31/2021, and a Recertification Period of 10/31/2023 to 05/31/2024. The diagnoses listed on the Plan of Care included Chronic Kidney Disease, Hypertension, Anemia, and Personal History of Malignant Neoplasm of Prostate. Additional review of the clinical record showed Employee # 5, a Registered Nurse prepared a “SN Recertification” comprehensive assessment dated 10/11/2023 and documented the patient attends Hemodialysis and has an AV (arteriovenous) Graft or Fistula in place to the left arm. Further review of the clinical record shows Employee # 5 prepared an “RN Supervisory Visit” note dated 02/02/2024. The note shows the nurse recorded a blood pressure measurement obtained on the affected extremity; the left arm with the dialysis access; 02/02/2024 blood pressure measured on the Left arm-136/81. The surveyor conducted a face-to-face interview with Employee #2, the agency’s Clinical Manager who acknowledged and confirmed the findings on 03/12/2024 at approximately 2:10 PM.

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 interview with agency staff, review of clinical records and the agency's policy, the Home Health Agency failed to update comprehensive assessments at discharge for one (1) of three (3) clinical records for discharged patients, (Patient #10). Findings included: A review of the Home Health Agency's policy number #10301, titled "Discharge/Transfer Referral of Patients" showed that any discharge, transfer or referral of patients shall occur in an appropriate manner, ensuring that relevant information is communicated to appropriate parties and in such a way as to prevent harm to the patient. The surveyor conducted a review of Patient #10’s clinical record on 03/14/2024 at approximately 11:10 AM that showed a Start of Care Date of 06/05/2023, and an Initial Certification Period from 06/05/2023 through 08/03/2023. The admitting diagnosis was “Presence of Right Artificial Knee Joint” and showed the patient was referred to the home health agency due to decreased bed mobility, decreased upper body dressing skills, decreased upper extremity strength, sitting and standing balance. The physician’s ‘Orders for discipline and treatments’ on and Plan of Care directed Physical and Occupational Therapy services each for three times a week. Additional review of the clinical record showed Employee#7, a registered nurse prepared an OASIS (Outcome and Assessment Information Set) -E assessment for Start of Care dated 06/05/2023. Further review showed Patient #10 received approximately 10 sessions of Occupational therapy and 12 sessions of Physical therapy. The clinical record showed Employee #25 prepared an “OT (Occupational therapy) Discharge Summary dated 07/31/2023 that was incomplete. The Discharge Summary did not include the medications the patient was on at the time of discharge. The surveyor conducted a face-to-face interview with Employees #1, the administrator, and #2 the Clinical Manager who acknowledged and confirmed the findings on 03/14/2024 at approximately 1:30 PM.

The State Agency conducted an unannounced Federal Recertification Home Health Agency Survey from 09/16/2022 through 09/22/2022, for compliance with Emergency Preparedness requirements for Home Health Agencies. On the first day of the survey, the Home Health Agency reported that their total active census was 190 patients, and their number of unduplicated admissions for skilled services, during the most recent 12-month period was 85 patients. The surveyor found the Home Health Agency in substantial compliance with the requirements for Emergency Preparedness Program. No deficiencies were cited.

The State Agency conducted an unannounced Federal Recertification Home Health Agency Survey, and a Focused Infection Control Survey from 09/16/2022 through 09/22/2022. On the first day of the survey, the Home Health Agency reported that their total active census was 190 patients, and their number of unduplicated admissions for skilled services, during the most recent 12-month period was 85 patients. The sample size consisted of 17 OASIS (Outcome and Assessment Information Set) Validation Reports, 20 personnel records, plus the agency’s COVID-19 (Coronavirus disease 2019) Staff Vaccination Matrix for Vaccination Compliance, 10 clinical records; including seven (7) required record reviews, and 3 (three) record reviews in place of Home Visits not conducted. The surveyor cited Standard Level deficiencies based on interviews with agency staff, review of clinical records, and the agency's policies. Glossary ADLs- Activities of Daily Living Cg- Caregiver CMS - Centers for Medicare and Medicaid Services COVID-19- Coronavirus Disease 2019 CPAP (Continuous Positive Airway Pressure D/C - discontinue; discharge DME - Durable Medical Equipment F2F- Face-to Face GU-Genito Urinary IU - International Units Lt.- Left LA- Long Acting mg - milligram(s) mg/dl- milligrams per deciliter ml - milliliter(s) mm Hg - milliliter(s) of Mercury OASIS- Outcome and Assessment Information Set PHE- Public Health Emergency PRN - As Needed RN - Registered Nurse Rt. Right SN - Skilled Nurse (ing) SOC - Start of Care TD -Transdermal WK- week (s) % - Percentage

Completion of the comprehensive assessment CFR(s): 484.55(b) Standard: Completion of the comprehensive assessment. This STANDARD is not met as evidenced by: Based on review of clinical records, the agency’s policy, and interview with agency staff, the agency's clinical staff failed to conduct a patient-specific comprehensive assessment in one (1) of 10 clinical records (Patient #4). Findings included... A review of the Home Health Agency’s undated policy titled, “Completion of The Comprehensive Assessment”, reference #10008, showed that the Comprehensive Assessment includes the following information but not limited to the patient’s problems, needs and strengths, pertinent diagnoses, pertinent physical findings, and the patient’s pertinent medical history. The surveyor conducted a review of Patient#4’s clinical record on 09/19/2022 at approximately 3:10 PM that showed a Plan of Care for Non Skilled Services with a Start of Care date of 05/16/2020, and an annual Recertification Period 05/16/2022 to 05/15/2023. The clinical record contained an ‘SN (Skilled Nurse) Recertification’ assessment for non-skilled services dated 05/20/2022 and electronically signed by Employee #7, a Registered Nurse. Additional review of the assessment showed the following incomplete and/or inaccurate items: i. Assessment item titled ‘Patient History & Diagnoses’ showed a blank space ii. Assessment item titled ‘Allergies’ showed a blank space The diagnoses listed on the assessment included Unstable Burst Fracture of Thoracic Vertebrae #11 and #12, Open Fracture of the Left Fibula Shaft, and Absence of Right Leg Above Knee. iii. The assessment did not include corresponding dates of onset or exacerbation for each diagnosis. iv. Assessment item titled ‘Surgical Procedure’ showed “Toe injury operation” The Assessment did not include all of the patient's diagnoses v. Assessment item titled ‘Functional Limitations (Locator #18.A)’ showed an “X”, corresponding with Paralysis vi. Assessment item titled ‘Supportive Assistance’ showed blank spaces vii. Assessment item titled ‘Cultural’ showed blank spaces viii. Assessment item titled ‘Supportive Assistance Interventions’ included the entry “…Nurse to educate client/caregiver on safety with the use of cane, Walker, CPAP (Continuous Positive Airway Pressure, Oxygen, Nebulizer treatment machine, wheelchair...” The clinical record did not include documented evidence that Patient #4’s diagnoses included Asthma, and there was no evidence of physician’s orders for Oxygen, Nebulizer, or CPAP treatment ix. Assessment item titled ‘Pain Scale’ showed a blank space Assessment item titled ‘Integumentary’ showed Wound 1, date of onset 05/02/2022; located on the Left Leg; Type of wound described as a Pressure Ulcer; Stage 1. x. Assessment item titled ‘Respiratory’ showed no checked boxes, no assessment of lung sounds, and the section for ‘Comments’ was blank xi. Assessment item titled ‘Elimination’ included the presence of an indwelling Foley Catheter; last changed 05/30/2022; The assessment did not include a size of the catheter, and an additional back-up in the event of accidental dislodging xii. In addition, assessment item titled ‘Elimination’ showed Employee #7 placed an X in the box corresponding with ‘Ostomy Type’, and did not assess the appearance of the stoma, or the surrounding skin xiii. Assessment item titled ‘Neuro/Behavioral’ showed an “X” corresponding with ‘Quadriplegia’, and the section for ‘Comments’ was blank xiv. ADL/IADLs (Activities of Daily Living and Instrumental activities of daily living); Activities Permitted "Complete bed rest", "Up as tolerated", "Transfer bed-chair", and "Wheelchair" xv. Assessment item titled 'Musculoskeletal' showed Limited ROM (Range of Motion) in the lower extremities, and Amputation to Right Above the Knee The surveyor conducted a face-to-face interview with Employees #1, the agency’s Administrator and #5, a Registered Nurse. They both acknowledged and confirmed the findings on 09/22/2022 at approximately 10:30 AM.

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 interviews with agency staff , review of clinical records and the agency's policy, the agency's staff failed to ensure that patients' Plans of Care were individualized and included all required elements in four (4) of 10 clinical records (Patients #1, 4, 7, and 8). Findings included... A review of the Home Health Agency’s undated policy titled, “Plan of Care (Plan of Treatment)”, reference #10004, showed that each plan of care must be established and authorized in writing by the physician based on an evaluation of the patient’s immediate and long-term needs. In addition, each plan of care shall include but not limited to all pertinent diagnoses, and safety measures required to protect the patient from injury. A. The surveyor conducted a review of Patient#1’s clinical record on 09/16/2022 at approximately 2:20 PM that showed a Plan of Care for Non Skilled Services with a Start of Care date of 09/26/2021, and an annual Certification Period of 09/26/2021 to 09/25/2023. The diagnoses listed on the Plan of Care included End Stage Renal Disease, AV [Arteriovenous] GRAFT, Hypertension, and Category 3 Blindness of Both eyes. The clinical record contained a Non-OASIS (Outcome and Assessment Information Set) Start of Care Assessment dated 09/26/2021 that showed the diagnoses listed under the assessment item titled ‘Patient History and Diagnoses’ “Fluid Overload” and “Extra Renal Uremia”. i. The Plan of Care did not reflect all known diagnoses including Fluid Overload and Extra Renal Uremia. Continued review of the Plan of Care showed the following incomplete and/or inaccurate items: Plan of Care item titled ‘Medications’ included Onglyza 5 milligram daily, by mouth; Famotidine 40 milligram daily, by mouth; Pantoprazole 40 milligram daily, by mouth; Furosemide 80 milligram twice daily, by mouth; and Sevelamer Carbonate 800 milligram, three times daily, by mouth ii. The clinical record including the Plan of Care did not reflect documentation of adequate indications for administration of each medication, and the diagnosed condition for which the medications are prescribed. Plan of Care item titled 'Orders for Discipline and Treatments (Specify Amount/ Frequency and Duration)’ directed the skilled nurse to visit the patient every 30 to 60 days for Personal Care Aide supervision, and as needed for medically related issues. In addition, the orders included "...Nurse to assess Peritoneal Dialysis site for infection..." iii. The clinical record including the Plan of Care did not reflect evidence of physician’s orders for administration of hemodialysis. The surveyor conducted a face-to-face interview with Employees #1, the agency’s Administrator and #5, a Registered Nurse. They both acknowledged and confirmed the findings on 09/22/2022 at approximately 10:30 AM. B. The surveyor conducted a review of Patient#4’s clinical record on 09/19/2022 at approximately 3:10 PM that showed a Plan of Care for Non Skilled Services with a Start of Care date of 05/16/2020, and an annual Recertification Period 05/16/2022 to 05/15/2023. The diagnoses listed on the Plan of Care included Unstable Burst Fracture of Thoracic Vertebrae 11 and 12, Open Fracture of the Left Fibula Shaft, and Absence of Right Leg Above Knee. Additional review of the clinical record showed the following incomplete and/or inaccurate items: i.Plan of Care item titled ‘Medications’ included a. Polymyxin B Ophthalmic Twice/day Transdermal (TD). The medication order included more than one route for administration; instillation and transdermal. b. Neomycin Twice/day Transdermal (TD). The clinical record did not include a dosage or concentration, an indication for administration, or an identified anatomical area for application of Neomycin. ii. Plan of Care item titled ‘DME [Durable Medical Equipment] and Supplies’ reflected a ‘Foley Catheter’ and did not include the size of the catheter, and an additional back-up in the event of accidental dislodging, the amount of sterile water used inflate the balloon, or extra urine drainage bags to collect urine. iii. Plan of Care item titled ‘Allergies’ showed a blank space iv. Plan of Care item titled ‘Activities Permitted’ showed complete bed rest, up as tolerated, transfer bed-chair, partial weight bearing, and wheelchair. The entry reflected conflicting information. v. Plan of Care item titled ‘Functional Limitations' included the diagnosis of “Paralysis” which was not included amongst the aforementioned diagnoses on the Plan of Care. vi. Plan of Care item titled ‘Orders for Discipline and Treatments (Specify Amount, Frequency and Duration)’ included orders that directed the skilled nurse to visit the patient every 30-62 days for Personal Care Aide supervision; and as needed home visits for this current re-certification period for any medical related issues. In addition, the orders directed Personal Care Aide services 8 hours daily, 7 days per week for this re-certification period, to assist the patient with activities of daily living. Further, the physician’s orders directed the Nurse to educate client/caregiver on safety with the use of cane, walker, CPAP [continuous positive airway pressure machine], Oxygen, Nebulizer treatment machine. Continued review of the clinical record did not include documented evidence of diagnoses associated with Oxygen, nebulizer, or treatment with CPAP equipment. vii. Plan of Care item titled ‘Goals/ Rehabilitation Potential/Discharge Plans’ reflects “Patient with memory deficit, L (left) or R (Right) side paralysis due to CVA [Cerebrovascular Accident]. The Plan of Care did not include “CVA” amongst the aforementioned diagnoses and specify left or right-side paralysis. viii. Plan of Care item titled ‘COVID [Coronavirus disease]-19 TEACHING’ showed the entry “…There is currently no vaccine to prevent COVID-19” The plan of Care reflected inaccurate information as the first COVID- 19 vaccine was publicly approved in the United States of America in August 2021. ix. Also, ‘Plan of Care item titled ‘Goals/Rehabilitation Potential/Discharge Plans’ showed "Patient with memory deficit, L or R side paralysis due to CVA, Poor hand coordination, Lives Alone, Unable to perform own ulcer or wound care, No able/willing cg (caregiver) to assume pt’s (Patient's) care safely. SN to assess wound, ulcer for healing and infection. SN to measure wound, ulcer weekly recording results. Assess drainage for color, amount, odor, and consistency. Report any abnormal findings to MD. Using aseptic technique, SN to clean wound, ulcer with Normal Saline, pat dry, pack with sterile strap(Nu gauze), cover with 4 x 4 dressing gauze and secure with tape, kerlix..." x. The Plan of Care did not include the identification of a wound/ulcer amongst the aforementioned diagnoses and specify the location. Plan of Care item titled ‘Goals/Rehabilitation Potential and Discharge Plan’ showed teaching Colostomy care, ostomy management, including the anatomy and physiology. xi. The Plan of Care did not include the presence of a ‘Colostomy’ amongst the aforementioned diagnoses. The surveyor conducted a face-to-face interview with Employees #1, the agency’s Administrator and #5, a Registered Nurse. They both acknowledged and confirmed the findings on 09/22/2022 at approximately 10:30 AM. C. The surveyor conducted a review of Patient#7’s clinical record on 09/21/2022 at approximately 9:50 AM that showed a Plan of Care for Skilled Services with a Start of Care date of 08/08/2022, and an initial Certification Period for skilled services, from 08/08/2022 to 10/06/2022. The diagnoses listed on the Plan of Care included Cerebral Infarction, Non-Pressure Chronic Ulcer of Right Ankle, Obesity, and Paresthesia of Skin. The clinical record contained a Start of Care assessment with OASIS (Outcome and Assessment Information Set) elements dated 08/08/2022 that showed the registered nurse assessed Patient # 7’s ‘Risk for Hospitalization’ at (M1033). Additional review of the clinical record showed the following incomplete and/or inaccurate items: Plan of Care item titled ‘Medications’ included Lisinopril-Hydro Chlorothiazide, 10 MG [milligram] -12.5 MG, 1 TABLET by mouth daily i. The Plan of care did not include the diagnosis of hypertension, or indication for the administration of Hydro Chlorothiazide ii. Plan of Care item ‘DME and Supplies’ did not include wound care supplies for care of the Non-Pressure Chronic Ulcer of Right Ankle iii. Plan of Care item titled ‘Physician’s orders for discipline and treatment’ directed the skilled nurse to assess other co-morbidities, teach Oxygen use and safety measures. a. The Plan of Care included nursing goals including ‘Asthma’ b. The clinical record did not include documented evidence that Patient #7’s diagnoses included Asthma, and no evidence of physician’s orders for Oxygen iv. In addition, physician’s orders for discipline and treatment directed the skilled nurse to assess wound and skin for signs and symptoms of infections. a. Homebound Narrative shows “There is no data for this section”; and b. Medical Necessity shows “There is no data for this section” 'F2F [Face-to-Face] Addendum (Admission Narrative)' included “…Pt [Patient] will have adequate working knowledge of pharmacological & non-pharmacological management of CVA, O2 (Oxygen) use & safety…” The Plan of Care showed "...Client is a (high) risk for hospitalization..." and did not include potential signs and symptoms that characterize Patient #7 as at risk for hospitalization. The surveyor conducted a face-to-face interview with Employees #1, the agency’s Administrator and #5, a Registered Nurse. They both acknowledged and confirmed the findings on 09/22/2022 at approximately 11:25 AM. D. The surveyor conducted a review of Patient#8’s clinical record on 09/16/2022 at approximately 10:50 AM that showed a Plan of Care for Skilled Services with a Start of Care date of 06/15/2022, and an initial Certification Period from 06/15/2022 to 07/06/2022. The diagnoses listed on the Plan of Care included Malignant Neoplasm of the Recto-sigmoid Junction, and Disorders of the bladder. i. The Plan of Care did not reflect co-morbidities, if any. ii. Plan of Care item titled ‘Advanced Directives’ showed “There is no data for this section…” iii.The Plan of Care did not include information related to advanced directives Plan of Care item titled ‘Medications’ showed Acetaminophen one tablet daily by mouth iii. The Plan of Care did not include a prescribed dosage for Acetaminophen and an indication for administration. Plan of Care item titled ‘DME and Supplies’ showed alcohol pads, drainage bag, exam gloves, and irrigation solution iv. The Plan of Care did not include physician’s orders associated with treatment and services related to use of the drainage bag and irrigation solution v. Plan of Care item titled ‘Nutritional Requirements’ showed a blank space vi. Plan of Care item titled ‘Allergies’ showed a blank space Plan of Care item titled ‘Orders for Discipline and Treatments (Specify Amount/ Frequency and Duration)’ directed the skilled nurse to visit the patient two times a week. vii. The Plan of Care did not show a complete physician’s order including a duration for Skilled Nursing visits. In addition, the Plan of Care included the following references: “…Fasting blood sugar greater than (>) 250 or less than (<) 60. Random blood sugar…SN [Skilled Nurse] to instruct client to take pain medication before pain becomes severe to achieve better pain control…SN to instruct the Client/Caregiver on signs and symptoms of infection and infiltration. SN to change port dressing using sterile technique every…SN to instruct the Client/Caregiver on signs/symptoms of wound infection to report to physician…SN to perform/instruct on incision/suture site care & dressing…The purpose of an ileostomy…” viii. The Plan of Care did not include indications a diagnosis for blood sugar monitoring ix. The Plan of Care did not show all pertinent diagnoses including a wound The surveyor conducted a face-to-face interview with Employees #1, the agency’s Administrator and #5, a Registered Nurse. They both acknowledged and confirmed the findings on 09/22/2022 at approximately 9:45 AM.

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on interview with agency staff and review of clinical records, agency staff failed to provide services in accordance with current clinical practice guidelines and accepted professional standards of practice in two (2) of 10 clinical records (Patient #1 and 4). Findings include… A. The surveyor conducted a review of Patient#1’s clinical record on 09/16/2022 at approximately 2:20 PM that showed a Plan of Care for Non Skilled Services with a Start of Care date of 09/26/2021, and an annual Certification Period of 09/26/2021 to 09/25/2023. The diagnoses listed on the Plan of Care included End Stage Renal Disease, AV [Arteriovenous]Graft, Hypertension, and Category 3 Blindness of Both eyes. The clinical record contained a Non-OASIS Start of Care Assessment dated 09/26/2021 that showed the following diagnoses listed under the assessment item titled ‘Patient History and Diagnoses’; Fluid Overload, and Extra Renal Uremia. Additional review of the clinical record showed Employee # 8 conducted a Non-OASIS [Outcome and Assessment Information Set] Start of Care Assessment dated 09/26/2021. The assessment showed Patient#1’s dialysis access, an Arteriovenous Fistula located to the Left arm. Further review of the Start of Care Assessment showed Employee # 8 recorded Patient #1’s blood pressure measurements obtained on the affected extremity, Left Arm. The surveyor conducted a face-to-face interview with Employees #1, the agency’s Administrator and #5, a Registered Nurse. They both acknowledged and confirmed the findings on 09/22/2022 at approximately 10:30 AM. B. The surveyor conducted a review of Patient#4’s clinical record on 09/19/2022 at approximately 3:10 PM that showed a Plan of Care for Non Skilled Services with a Start of Care date of 05/16/2020, and an annual Recertification Period 05/16/2022 to 05/15/2023. The diagnoses listed on the Plan of Care included Unstable Burst Fracture of Thoracic Vertebrae 11 and 12, Open Fracture of the Left Fibula Shaft, and Absence of Right Leg Above Knee. Additional review of the Plan of Care showed the following incomplete and/or inaccurate items: Plan of Care item titled ‘Medications’ included a. "Polymyxin B Ophthalmic Twice/day Transdermal (TD)"; The medication order included more than one route for administration: instillation and transdermal, and did not include a specific preparation such as ointment, solution, or emulsion b. "Neomycin Twice/day Transdermal (TD)". The physician’s order did not include a dosage or concentration, an indication for administration, or an identified anatomical area for application of Neomycin. In addition, the physician’s orders did not include a dosage or concentration, an indication for administration The prescribed medications included incomplete, inaccurate, and conflicting information. The clinical record lacked documented evidence that clinical staff contacted the prescribing physician to verify the orders. The surveyor conducted a face-to-face interview with Employees #1, the agency’s Administrator and #5, a Registered Nurse. They both acknowledged and confirmed the findings on 09/22/2022 at approximately 10:50 AM.

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 interviews with agency staff, review of clinical records and the agency's policy, the agency's clinician failed to document complete discharge summaries in three (3) of four (4) closed clinical records for patients discharged from the agency (Patients #2, 6, and 10). Findings included... Review of the Home Health Agency’s undated policy titled, “Discharge Summary”, reference #10302, showed that Discharge Summaries shall include the reason for the patient’s admission to home health; the types and frequency of services provided; medications the patient is on at the time of discharge; the patient’s condition at discharge; the patient outcomes in meeting the goals in the plan of care; and patient and family post-discharge instructions. A. The surveyor conducted a review of Patient#2's closed clinical record on 09/22/2022 at approximately 1:25 PM that showed a Plan of Care for Skilled Services with a Start of Care date of 04/27/2022, and an initial Certification Period from 04/27/2022 to 06/25/2022. The diagnoses listed on the Plan of Care included Aphasia, and Dysphagia. Additional review of the Plan of Care showed physician orders directed the following: Skilled Nurse to instruct patient/caregiver on new and/or changed medications; Physical Therapist to assess rehabilitation potential and determine need for gait training; Occupational Therapist to assess functional status; and Home Health Aide to provide assistance with personal care and activities of daily living. The clinical record contained a “Home Health Discharge Summary (Auto-Generated)” report dated 07/04/2022. Further review of the clinical record showed Patient #2 received Skilled Nursing, Physical Therapy, Occupational Therapy, and Home Health Aide services. The Discharge Summary did not include i. all types of services provided and frequency of services; ii. reason for admission to Home Health/Continued Services; and iii. discharge instructions. The surveyor conducted a face-to-face interview with Employees #1, the agency’s Administrator and #5, a Registered Nurse. They both acknowledged and confirmed the findings on 09/22/2022 at approximately 11:05 AM. B. The surveyor conducted a review of Patient#6’s clinical record on 09/22/2022 at approximately 10:10 AM that showed a Plan of Care for Skilled Services with a Start of Care date of 09/02/2022, and an initial Certification Period 09/02/2022 to 10/31/2022. The diagnoses listed on the Plan of Care included Malignant Neoplasm of the Rectum, Drug Induced Polyneuropathy, and Seizures. The clinical contained a “Home Health Discharge Summary (Auto-Generated)” report dated 07/04/2022. Further review of the clinical record showed Patient #6 received Skilled Nursing services. The Discharge Summary did not include i. reason for admission to Home Health/Continued Services. The surveyor conducted a face-to-face interview with Employees #1, the agency’s Administrator and #5, a Registered Nurse. They both acknowledged and confirmed the findings on 09/22/2022 at approximately 10:50 AM. C. The surveyor conducted a review of Patient#10’s clinical record on 09/22/2022 at approximately 1:25 PM that showed a Plan of Care for Skilled Services with a Start of Care date of 09/23/2021, and an initial Certification Period from 09/23/2021 to 11/21/2021. The diagnoses listed on the Plan of Care included Type 2 Diabetes Mellitus, Weakness, Hypertension, Osteoarthritis of Knee, Gout, Chronic Kidney Disease, Open Angle Glaucoma, Bradycardia, Urinary Tract Infection, and Atherosclerotic Heart Disease. Additional review of the clinical record showed the agency provided Patient #10 with Physical Therapy, Occupational Therapy, and Personal Care Aide Services. Further review of the clinical record showed Employee#11, an Occupational Therapist, documented a "Home Health End-of-Episode Summary (Auto- Generated)” report that shows the date of the last visit 12/24/2021. Patient #10's 'Discharge Summary' report was incomplete and did not contain the following items: i. Reason for admission to home health; ii. ii. Type of services provided and frequency of services; iii. iii. Patient’s discharge condition; and iv. iv. Patient and family post-discharge instructions. The surveyor conducted a face-to-face interview with Employees #1, the agency’s Administrator and #5, a Registered Nurse. They both acknowledged and confirmed the findings on 09/22/2022 at approximately 1:50 PM