Lifeline Healthcare Services, Inc.

“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 observation, interview, and record review the agency failed to meet the Condition for Comprehensive Assessment of Patients as evidenced by: Refer to G520: Based on observation, record review and interview the agency failed to ensure comprehensive assessments were completed within 5 calendar days after the start of care for 4 (Patient’s #1, 2, 3 and 4) of 4 current patients. Failure to complete SOC comprehensive assessments placed all 4 patients at risk of poor care planning, a decline in health status and poor outcomes. Refer to G536: Based on observation, record review and interview the agency failed to ensure comprehensive assessments reflected the patient’s current status and included a review of all medications for 4 (Patient’s #1, 2, 3 and 4) of 4 current patients. The agency failed to ensure reviews of all medications Patients (#1-4) were currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects or drug interactions, duplicate drug therapy, and noncompliance with drug therapy as well as the dose, route and frequency of all medications. Failure to identify all prescription and non-prescription medications the patients currently used placed all 4 patients at risk of possible side effects and drug interactions. Refer to G550: Based on record review and interview the agency failed to update the comprehensive assessment at discharge for 3 (Patients #5, 6 and 7) of 3 discharged patient records reviewed. The patient record did not contain a completed discharge comprehensive assessment that included all OASIS items. This failure potentially placed the patients at risk of poor health outcomes when ongoing care after discharge was not known.”

“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 observation, interview, and record review the agency failed to meet the Condition for Care Planning, coordination of services and quality of care as evidenced by: Refer to G572: Based on observation, record review and interview, the agency failed to ensure Plans of Care were developed to include all required items in CFR 484.60(a)(2), measurable outcomes and goals for 4 (Patients #1, 2, 3 and 4) of 4 current patients. This failure placed all 4 patients at risk of poor care planning, a decline in health status and poor outcomes. Refer to G580: Based on record review and interviews, the agency failed to ensure wound care treatments were administered only as ordered by a physician or practitioner for 1 (Patient #3) of 1 patient who received wound care after discharge from the agency. This failure placed Patient #3 at risk of poor care planning, a decline in the wound status, infection and poor outcomes.”

“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 record review and interview the agency failed to encode and electronically transmit each completed OASIS assessment (a tool used by CMS to collect certain patient information) to the CMS system within 30 days of completing the assessment of the beneficiary for 43 OASIS assessments submitted during 01/01/2024 to 01/01/2025 for 31 patients. This failure meant that poor care patterns could not be identified by the agency or CMS potentially subjecting patients to poor health outcomes. FINDINGS INCLUDE: The surveyor reviewed the agency OASIS errors report in iQies (a CMS data-based system for patient analysis of care trends) on 01/16/2025 which documented the agency had submitted 43 comprehensive assessments more than 30 days after the date of the assessment. The report listed 31 patient names as being affected by the late transmission of their comprehensive assessments from 01/01/2024 to 01/01/2025. In an interview with the Administrator/DON on 01/16/2025 at 12:30 PM, the surveyor asked about the late OASIS assessment transmissions. The Administrator stated the Alternate Administrator was responsible for uploading the assessments and he had been out of town since the end of October 2024. The surveyor showed the Administrator the report and stated the last time a patient assessment was transmitted to iQies was April 2024. The Administrator/DON stated she didn’t realize the Alternate Administrator had not uploaded the OASIS since last April (2024). The surveyor asked if the OASIS reports were reviewed as part of the agency’s QAPI process. The Administrator/DON stated they were. The surveyor asked why the QAPI reports provided for the surveyor to review did not include a review of the OASIS assessment transmissions for last year (01/01/2024 to 01/01/2025). The Administrator/DON did not respond. On 01/23/2025 at 11:00 AM, the Administrator/DON provided additional documentation for the surveyor to review and stated, “it’s all in there, but so many things were misplaced.” The Administrator/DON provided a different QAPI binder than had been provided on 01/16/2025 and 3 action plans the Administrator/DON stated had been found in the agency. Review of the additional QAPI binder included QAPI meetings dated 10/14/2024 and 01/08/2025. The 3 action plans were dated 12/05/2024 and signed by the Administrator/DON. In an interview with the Administrator/DON on 01/23/2025 at 3:20 PM, the surveyor asked if the Alternate Administrator had returned from out of town and was available. The Administrator/DON stated she didn’t know if he was back. On 01/23/2025 at 5:30 PM, the surveyor informed the Administrator/DON the additional documentation provided at 11:00 AM (on Exit day 01/23/2025) were not accepted as evidence for compliance. The Administrator/DON did not inform the surveyor on 01/16/2025 at 12:30 PM or any time during the survey that additional QAPI meetings and action plans to show compliance had been done and would be provided. The documents were not provided until the survey EXIT day. The Administrator stated she would accept that she did not ensure the (action) plans were followed and that the corrections had been made yet, but that she did complete the action plans. Agency policy, dated 05/01/2011, quoted in part, “MEDICAL RECORD INFORMATION TIMELINES, IM.10, … PROCEDURE: … 1.11 Completed and encoded OASIS data will be transmitted to the state within 30 days …””

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure Plans of Care were developed to include all required items in CFR 484.60(a)(2), measurable outcomes and goals for 4 (Patients #1, 2, 3 and 4) of 4 current patients. The patients were receiving home health services without the plan of care being established. This failure placed all 4 patients at risk of poor care planning, a decline in health status and poor outcomes. FINDINGS INCLUDE: CFR 484.60(a)(2) 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. Definitions: Patient-specific measurable outcome is a change in health status, functional status, or knowledge, which occurs over time in response to a health care intervention that provides end-result functional and physical health improvement/stabilization. Patient-specific goals must be individualized to the patient based on the patient’s medical diagnosis, physician or allowed practitioner orders, comprehensive assessment and patient input. In an interview with the Administrator/DON on 01/16/2025 at 12:20 PM, the surveyor asked about the agency’s current active patients. The Administrator/DON stated she only had 4 active patients and she had already seen the patients for their SOC and would be completing the SOC OASIS on them. In an interview with the Administrator/DON on 01/21/2025 at 1:15 PM the surveyor asked for the POC for Patients #1-4. The Administrator/DON stated, “don’t have them.” The surveyor asked if the POC’s would be populated if the OASIS SOC was completed. The Administrator/DON stated, “yes when I do the OASIS, the POC is populated in the (EHR) system. But those (SOC OASIS’s) aren’t done either.” Patient #1: An agency form titled, “PHYSICIAN ORDER” was dated 01/16/2025 at 5:15 PM and digitally signed by the Administrator/DON. The order included: SN to assess/evaluate and admit to HHC for assessment/monitoring of medications, assess/evaluate vital signs. … SN to instruct on disease conditions, medications and home safety. SN to assist in prefilling and manage medications. SN frequency was once a week for nine weeks and 2 PRN. An agency form titled, “CONSENT FOR SERVICE” was signed by Patient #1 and the Administrator/DON and dated 01/16/2025. The frequency of visits was SN once a week for nine weeks and 2 PRN. During a home visit interview with Patient #1 on 01/21/25 at 4:00 PM, the surveyor asked about the care and services provided by the agency. Patient #1 stated, “she (Administrator/DON) visits about every week. She fills my med (medication) box and if she goes out of town, she fills it for 2 weeks.” The Patient stated she received chemotherapy for lung cancer every three weeks. An individualized POC was not developed for Patient #1. Patient #2: An agency form titled, “PHYSICIAN ORDER” was dated 01/15/2025 at 2:00 PM and digitally signed by the Administrator/DON. The order included: SN to assess/evaluate and admit to Home Health Services. SN to perform routine suprapubic (above the pubic bone) catheter care with 16 french (the size of a plastic tube placed in the bladder to assist with draining urine); SN to perform digital rectal stimulation for bowel evacuation three times weekly and as needed; SN to flush suprapubic catheter with (bladder rinse) with [sic] 160 mg Gentamicin mix (pre-mixed) with 30 ml of bladder rinse solution and clamp catheter for 30 minutes 3 times weekly; SN to flush catheter with 300 ml sterile water or normal saline 3 times weekly or per standard procedure if gentamicin is not available. PT to assess/evaluate. An agency form titled, “CONSENT FOR SERVICE” was signed by Patient #2’s family member and the Administrator/DON and dated 01/15/2025. The frequency of visits was SN three times a week for nine weeks and 2 PRN. PT evaluation was marked “N/A.” During a home visit interview with Patient #2 on 01/22/25 at 12:30 PM, the surveyor observed the Administrator/DON provide bladder and bowel nursing care to the patient who was bedbound and unable to move her arms and legs. The surveyor asked about the care and services provided by the agency. Patient #2 stated, “she (Administrator/DON) comes 3 times a week for my bowel routine and bladder care, she also assists with medications (box fill).” An individualized POC was not developed for Patient #2. Patient #3: An agency form titled, “PHYSICIAN ORDER” was dated 01/16/2025 at 4:00 PM and digitally signed by the Administrator/DON. The order included: SN to assess/evaluate and admit to Home Health Services. Please follow up with wound care specialist for current wound care orders. SN frequency two times a week for nine weeks and 2 PRN. An agency form titled, “CONSENT FOR SERVICE” was signed by Patient #3 and the Administrator/DON and dated 01/16/2025. The frequency of visits was SN three times a week and 2 PRN. During a home visit interview with Patient #3 on 01/22/25 at 10:30 AM, the surveyor observed the Administrator/DON provide wound care to the patient’s buttocks at multiple areas. The surveyor asked about the care and services provided by the agency. Patient #3 stated the nurse (Administrator/DON) changed his wound dressings on Wednesday and Fridays and the wound “doctor” (specialist) changed the dressings on Mondays. He stated it was very difficult to get comfortable due to the location of the wounds and the pain medication either made him sleep or “wired” and he used Tramadol for pain now. He stated she (Administrator/DON) also helped fill his medications and make sure he had refills. He stated, “she doesn’t put them in a box, just takes a picture of the bottle.” An individualized POC was not developed for Patient #3. Patient #4: An agency form titled, “PHYSICIAN ORDER” was dated 01/16/2025 at 10:00 AM and digitally signed by the Administrator/DON. The order included: SN to assess/evaluate and admit to Home Health Services. SN frequency was two times a week for three weeks, then once a week for six weeks and 2 PRN. PT to assess and evaluate and treat per PT plan of care. An agency form titled, “CONSENT FOR SERVICE” was signed by Patient #4 and the Administrator/DON and was dated 01/16/2025. The frequency of visits was SN once a week for nine weeks and 2 PRN. During a home visit interview with Patient #4 on 01/22/25 at 3:00 PM, the surveyor asked about the care and services provided by the agency. Patient #4 stated had been in and out of the hospital since November 2024 and she was last discharged from the hospital 12/24/2025. She stated she understood home health care would begin once she returned home. She was visited by the Administrator/DON last week and the PT visited this week for the evaluation. Patient #4 stated she knew her medications and her family member also assisted with medication reminders for her. An individualized was not developed for Patient #4. In an interview with the Administrator/DON on 01/23/2025 at 3:30 PM, the surveyor reviewed the findings and asked if the POC’s for active Patient’s #1,2,3 and 4 were completed. The Administrator/DON stated none of the POC’s were completed. The surveyor asked why the POC’s were not completed. The Administrator/DON stated, “it’s the same reason, if the assessment is not done in the system, a POC is not generated, I’ve seen the patients, but haven’t done all the paperwork.” The surveyor asked how patient care could be affected by POC’s not completed for the patients. The Administrator/DON stated, “I take full responsibility, I have to get up, these are things you can fix, I’ll get help. I’m actually glad you came in. I know I need to fix things.” Agency policy, dated 05/01/2011, quoted in part, “MEDICAL RECORD INFORMATION TIMELINES, IM.10, … PROCEDURE: … 1.3 Plan of care is established within 3-5 days of admission to Agency … 1.10 An Admission Medical Record is assembled by the fifth (5th) working day after admission. …” Agency policy, dated 04/17/2006, quoted in part, “PLAN OF CARE, TX.6, … POLICY: Agency will utilize data/information gathered during patient assessments in the care planning process which involves the identification of patient goals, actions or interventions that will resolve or alleviate the patient’s problems and/or needs. … PROCEDURE: 1. The appropriate licensed professional staff member, with physician participation, is responsible for developing the plan of care within 3 – 5 days of the initial assessment. …”

“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 observation, record review and interview the agency failed to ensure comprehensive assessments were completed within 5 calendar days after the start of care for 4 (Patient’s #1, 2, 3 and 4) of 4 current patients. Failure to complete SOC comprehensive assessments placed all 4 patients at risk of poor care planning, a decline in health status and poor outcomes. FINDINGS INCLUDE: On 01/16/2025 at 12:20 PM, the surveyor asked the Administrator/DON about the agency’s current active patients. The Administrator/DON stated she only had 4 active patients and she had already seen the patients for their SOC and would be completing the SOC OASIS on them. In an interview with the Administrator/DON on 01/21/2025 at 1:15 PM the surveyor asked about SOC comprehensive assessments for Patients #1, 2, 3 and 4. The Administrator/DON stated, “those aren’t done either.” Patient #1: An agency form titled, “PHYSICIAN ORDER” was dated 01/16/2025 at 5:15 PM and digitally signed by the Administrator/DON. The order included: SN to assess/evaluate and admit to HHC for assessment/monitoring of medications, assess/evaluate vital signs. … SN to instruct on disease conditions, medications and home safety. SN to assist in prefilling and manage medications. SN frequency was once a week for nine weeks and 2 PRN. An agency form titled, “CONSENT FOR SERVICE” was signed by Patient #1 and the Administrator/DON and dated 01/16/2025. The frequency of visits was SN once a week for nine weeks and 2 PRN. During a home visit interview with Patient #1 on 01/21/25 at 4:00 PM, the surveyor asked about the care and services provided by the agency. Patient #1 stated, “she (Administrator/DON) visits about every week. She fills my med (medication) box and if she goes out of town, she fills it for 2 weeks.” The Patient stated she received chemotherapy for lung cancer every three weeks. The SOC comprehensive assessment was due to be completed no later than 5 calendar days after the start of care-- 01/21/2025. The clinical record failed to contain an initial SOC comprehensive assessment. Patient #2: An agency form titled, “PHYSICIAN ORDER” was dated 01/15/2025 at 2:00 PM and digitally signed by the Administrator/DON. The order included: SN to assess/evaluate and admit to Home Health Services. SN to perform routine suprapubic (above the pubic bone) catheter care with 16 french (the size of a plastic tube placed in the bladder to assist with draining urine); SN to perform digital rectal stimulation for bowel evacuation three times weekly and as needed; SN to flush suprapubic catheter with (bladder rinse) with [sic] 160 mg Gentamicin (an antibiotic used to treat bacterial infections) mix (pre-mixed) with 30 ml of bladder rinse solution and clamp catheter for 30 minutes 3 times weekly; SN to flush catheter with 300 ml sterile water or normal saline 3 times weekly or per standard procedure if gentamicin is not available. PT to assess/evaluate. An agency form titled, “CONSENT FOR SERVICE” was signed by Patient #2’s family member and the Administrator/DON and dated 01/15/2025. The frequency of visits was SN three times a week for nine weeks and 2 PRN. PT evaluation was marked “N/A.” During a home visit interview with Patient #2 on 01/22/25 at 12:30 PM, the surveyor observed the Administrator/DON provide bladder and bowel nursing care to the patient who was bedbound and unable to move her arms and legs. The surveyor asked about the care and services provided by the agency. Patient #2 stated, “she (Administrator/DON) comes 3 times a week for my bowel routine and bladder care, she also assists with medications (box fill).” The SOC comprehensive assessment was due to be completed no later than 5 calendar days after the start of care-- 01/20/2025. The clinical record failed to contain an initial SOC comprehensive assessment. Patient #3: An agency form titled, “PHYSICIAN ORDER” was dated 01/16/2025 at 4:00 PM and digitally signed by the Administrator/DON. The order included: SN to assess/evaluate and admit to Home Health Services. Please follow up with wound care specialist for current wound care orders. SN frequency two times a week for nine weeks and 2 PRN. An agency form titled, “CONSENT FOR SERVICE” was signed by Patient #3 and the Administrator/DON and dated 01/16/2025. The frequency of visits was SN three times a week and 2 PRN. During a home visit interview with Patient #3 on 01/22/25 at 10:30 AM, the surveyor observed the Administrator/DON provide wound care to the patient’s buttocks at multiple areas. The surveyor asked about the care and services provided by the agency. Patient #3 stated the nurse (Administrator/DON) changed his wound dressings on Wednesday and Fridays and the wound “doctor” (specialist) changed the dressings on Mondays. He stated it was very difficult to get comfortable due to the location of the wounds and the pain medication either made him sleep or “wired” and he used Tramadol for pain now. He stated she (Administrator/DON) also helped fill his medications and make sure he had refills. He stated, “she doesn’t put them in a box, just takes a picture of the bottle.” The SOC comprehensive assessment was due to be completed no later than 5 calendar days after the start of care-- 01/21/2025. The clinical record failed to contain an initial SOC comprehensive assessment. Patient #4: An agency form titled, “PHYSICIAN ORDER” was dated 01/16/2025 at 10:00 AM and digitally signed by the Administrator/DON. The order included: SN to assess/evaluate and admit to Home Health Services. SN frequency was two times a week for three weeks, then once a week for six weeks and 2 PRN. PT to assess and evaluate and treat per PT plan of care. An agency form titled, “CONSENT FOR SERVICE” was signed by Patient #4 and the Administrator/DON and was dated 01/16/2025. The frequency of visits was SN once a week for nine weeks and 2 PRN. During a home visit interview with Patient #4 on 01/22/25 at 3:00 PM, the surveyor asked about the care and services provided by the agency. Patient #4 stated had been in and out of the hospital since November 2024 and she was last discharged from the hospital 12/24/2025. She stated she understood home health care would begin once she returned home. She was visited by the Administrator/DON last week and the PT visited this week for the evaluation. Patient #4 stated she knew her medications and her family member also assisted with medication reminders for her. The SOC comprehensive assessment was due to be completed no later than 5 calendar days after the start of care-- 01/21/2025. The clinical record failed to contain an initial SOC comprehensive assessment. In an interview with the Administrator/DON on 01/23/2025 at 3:30 PM, the surveyor reviewed the findings and asked if the SOC comprehensive assessments were completed for Patient’s #1, 2, 3 and 4. The Administrator/DON stated none of the SOC or POC’s were completed. The surveyor asked why the SOC comprehensive assessments were not completed in 5 days of Patients #1,2,3 and 4’s SOC. The Administrator/DON stated she was not aware the SOC assessments were due in 5 days and she believed there were 30 days to complete the SOC assessments. The Administrator/DON stated, “when I thought about it, it’s just the 4 of them and I had 30 days, I can find somebody to do them or let me learn how to submit them.” The surveyor asked why the ADON or another RN employee of the agency did not complete the SOC assessments (for Patients #1-4). The Administrator/DON stated she knew the ADON had spoken with the surveyor, but she did not want to ask the ADON for help as she lived so far away from the agency and since she (Administrator/DON) had not been paid by Medicare for a long time, she really didn’t have the money to pay another RN to complete the SOC assessments. The surveyor asked how patient care could be affected by not having a SOC assessment completed. The Administrator/DON stated, “I’ve felt very overwhelmed, I just don’t know.” Agency policy, dated 05/01/2011, quoted in part, “MEDICAL RECORD INFORMATION TIMELINES, IM.10, … POLICY: Agency will ensure timely provision of care and services to meet the patient’s needs in compliance with all federal and state laws and regulations. … PROCEDURE: … 1.4 A Registered Nurse, Physical Therapist, or Speech Therapist will complete the Initial Comprehensive Assessment no later than five (5) calendar days after the start of care (SOC) for all patients in a licensed and certified agency …” Agency policy, dated 01/02/2007, quoted in part, “INITIAL PATIENT COMPREHENSIVE ASSESSMENT, PE.3, … POLICY: Each patient will receive a patient specific, comprehensive assessment, that incorporates OASIS data set for Medicare/Medicaid patients, completed by a Registered Nurse, …. PROCEDURE: A. Admission … 4. An RN, PT or ST, whoever is primary, will complete the Initial Comprehensive Assessment that incorporates the OASIS data set, no later than five (5) calendar days after the start of care for all patients in a licensed and certified agency … 8. The initial comprehensive assessment data/information will be gathered and documented on the following forms: … Initial Comprehensive Assessment Form, Medication Record Form, … 9. The Comprehensive Assessment will meet the following criteria: … Identify when an additional or more in-depth assessment is needed….””

“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 observation, record review and interview the agency failed to ensure comprehensive assessments reflected the patient’s current status and included a review of all medications for 4 (Patient’s #1, 2, 3 and 4) of 4 current patients. The agency failed to ensure reviews of all medications Patients (#1-4) were currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects or drug interactions, duplicate drug therapy, and noncompliance with drug therapy as well as the dose, route and frequency of all medications. Failure to identify all prescription and non-prescription medications the patients currently used placed all 4 patients at risk of possible side effects and drug interactions. Failure to identify all prescription and non-prescription medications the patients currently used placed all 4 patients at risk of possible side effects and drug interactions. FINDINGS INCLUDE: On 01/16/2025 at 12:20 PM, the surveyor asked the Administrator/DON about the agency’s current active patients. The Administrator/DON stated she only had 4 active patients and she had already seen the patients for their SOC and would be completing the SOC OASIS on them. On 01/16/2025 at 2:00 PM, the surveyor asked if the agency maintained any patient documents in a “hard chart” or in paper records. The Administrator/DON stated only the PAS clients charts were in folders, the skilled patients records were all scanned into the EHR system and there were no paper records for them now. On 01/21/2025 at 1:15 PM, the Administrator/DON provided physician’s verbal orders for HHC and signed consents for Patients #1, 2, 3 and 4. Patient #1: Review of the agency EHR revealed no current clinical documentation for Patient #1. An agency form titled, “PHYSICIAN ORDER” was dated 01/16/2025 at 5:15 PM and digitally signed by the Administrator/DON. The order included: SN to assess/evaluate and admit to HHC for assessment/monitoring of medications, assess/evaluate vital signs. … SN to instruct on disease conditions, medications and home safety. SN to assist in prefilling and manage medications. SN frequency was once a week for nine weeks and 2 PRN. An agency form titled, “CONSENT FOR SERVICE” was signed by Patient #1 and the Administrator/DON and dated 01/16/2025. The frequency of visits was SN once a week for nine weeks and 2 PRN. During a home visit interview with Patient #1 on 01/21/25 at 4:00 PM, the surveyor asked about the care and services provided by the agency. Patient #1 stated, “she (Administrator/DON) visits about every week. She fills my med (medication) box and if she goes out of town, she fills it for 2 weeks.” The Patient stated she received chemotherapy for lung cancer every three weeks. A review of all medications with a SOC comprehensive assessment was not completed. Patient #2: An agency form titled, “PHYSICIAN ORDER” was dated 01/15/2025 at 2:00 PM and digitally signed by the Administrator/DON. The order included: SN to assess/evaluate and admit to Home Health Services. SN to perform routine suprapubic (above the pubic bone) catheter care with 16 french (the size of a plastic tube placed in the bladder to assist with draining urine); SN to perform digital rectal stimulation for bowel evacuation three times weekly and as needed; SN to flush suprapubic catheter with (bladder rinse) with [sic] 160 mg Gentamicin mix (pre-mixed) with 30 ml of bladder rinse solution and clamp catheter for 30 minutes 3 times weekly; SN to flush catheter with 300 ml sterile water or normal saline 3 times weekly or per standard procedure if gentamicin is not available. An agency form titled, “CONSENT FOR SERVICE” was signed by Patient #2’s family member and the Administrator/DON and dated 01/15/2025. The frequency of visits was SN three times a week for nine weeks and 2 PRN. A piece of paper with a handwritten note, “(Patient #2) meds” was included with the Consent for Service form. The paper included names of medications and “… Gentamicin Irrigation ….” No dosage was included with the Gentamicin Irrigation. The paper did not include: frequency; potential side effects or potential interactions for any of the medications listed. During a home visit interview with Patient #2 on 01/22/25 at 12:30 PM, the surveyor observed the Administrator/DON provide bladder and bowel nursing care to the patient who was bedbound and unable to move her arms and legs. The surveyor asked about the care and services provided by the agency. Patient #2 stated, “she (Administrator/DON) comes 3 times a week for my bowel routine and bladder care, she also assists with medications (box fill).” A review of all medications with a SOC comprehensive assessment was not completed. Patient #3: An agency form titled, “PHYSICIAN ORDER” was dated 01/16/2025 at 4:00 PM and digitally signed by the Administrator/DON. The order included: SN to assess/evaluate and admit to Home Health Services. Please follow up with wound care specialist for current wound care orders. SN frequency two times a week for nine weeks and 2 PRN. An agency form titled, “CONSENT FOR SERVICE” was signed by Patient #3 and the Administrator/DON and dated 01/16/2025. The frequency of visits was SN three times a week and 2 PRN. During a home visit interview with Patient #3 on 01/22/25 at 10:30 AM, the surveyor observed the Administrator/DON provide wound care to the patient’s buttocks at multiple areas. The surveyor asked about the care and services provided by the agency. Patient #3 stated the nurse (Administrator/DON) changed his wound dressings on Wednesday and Fridays and the wound “doctor” (specialist) changed the dressings on Mondays. He stated the wound care specialist added a new medication to be used on the wounds and the nurse (Administrator/DON) had it today to use. He stated it was very difficult to get comfortable due to the location of the wounds and the pain medication either made him sleep or “wired” and he used Tramadol for pain now. He stated she (Administrator/DON) also helped fill his medications and make sure he had refills. He stated, “she doesn’t put them in a box, just takes a picture of the bottle.” A review of all medications with a SOC comprehensive assessment was not completed. Patient #4: An agency form titled, “PHYSICIAN ORDER” was dated 01/16/2025 at 10:00 AM and digitally signed by the Administrator/DON. The order included: SN to assess/evaluate and admit to Home Health Services. SN frequency was two times a week for three weeks, then once a week for six weeks and 2 PRN. An agency form titled, “CONSENT FOR SERVICE” was signed by Patient #4 and the Administrator/DON and was dated 01/16/2025. The frequency of visits was SN once a week for nine weeks and 2 PRN. During a home visit interview with Patient #4 on 01/22/25 at 3:00 PM, the surveyor asked about the care and services provided by the agency. Patient #4 stated she had been in and out of the hospital since November 2024 and was last discharged from the hospital 12/24/2025. Patient #4 stated she understood home health care would begin once she returned home and she was visited by the Administrator/DON last week, the PT visited this week for the evaluation. Patient #4 stated she knew her medications and her family member also assisted with medication reminders for her. A review of all medications with a SOC comprehensive assessment was not completed. In an interview with the Administrator/DON on 01/23/2025 at 3:30 PM, the surveyor reviewed the findings and asked if medication reviews were completed with the SOC comprehensive assessments for Patient’s #1, 2, 3 and 4. The Administrator/DON stated for Patient #1, she used the medication list from the (physician’s) progress note and she matched it with what was in the Patient’s home. For Patient #2, the Administrator/DON stated, “I have it (medication list), but it’s not updated, she takes OTC medications for prevention and only a couple prescriptions. I thought I had 30 days to complete.” For Patient #3, the Administrator/DON stated, “I thought I had 30 days to do everything, (I) need to update his list with the silver (new medication for wounds). For Patient #4, the Administrator/DON stated, “It’s the same answer, I thought I had 30 days (to complete the assessment).” The surveyor asked how patient care could be affected by not having medications reviewed. The Administrator/DON stated, “for (Patient #1), “I didn’t’ think this could affect the patient. I have a list of medications from the progress notes the other (medications) are OTC, I’m the one who does the boxes for 2 weeks. I use the med list in the progress note. I match with what is in the home. For Patient #2, I have it, but it’s not updated. I thought I had 30 days, for (Patient #3 and #4), it’s the same answer, I’ve felt very overwhelmed lately and I just don’t know.” Agency policy, dated 05/01/2011, quoted in part, “MEDICAL RECORD INFORMATION TIMELINES, IM.10, … POLICY: Agency will ensure timely provision of care and services to meet the patient’s needs in compliance with all federal and state laws and regulations. … PROCEDURE: … 1.4 A Registered Nurse, Physical Therapist, or Speech Therapist will complete the Initial Comprehensive Assessment no later than five (5) calendar days after the start of care (SOC) for all patients in a licensed and certified agency …” Agency policy, dated 01/02/2007, quoted in part, “INITIAL PATIENT COMPREHENSIVE ASSESSMENT, PE.3, … POLICY: Each patient will receive a patient specific, comprehensive assessment, that incorporates OASIS data set for Medicare/Medicaid patients, completed by a Registered Nurse, …. PROCEDURE: A. Admission … 4. An RN, PT or ST, whoever is primary, will complete the Initial Comprehensive Assessment that incorporates the OASIS data set, no later than five (5) calendar days after the start of care for all patients in a licensed and certified agency … 6. The Comprehensive Assessment will include but not limited to the following: … Medication history, including drug allergies, sensitivities and past adverse drug reactions … 8. The initial comprehensive assessment data/information will be gathered and documented on the following forms: … Initial Comprehensive Assessment Form, Medication Record Form, … 9. The Comprehensive Assessment will meet the following criteria: … Identify when an additional or more in-depth assessment is needed….””

“At discharge CFR(s): 484.55(d)(3) At discharge. This Element is not met as evidenced by: Based on record review and interview the agency failed to update the comprehensive assessment at discharge for 3 (Patients #5, 6 and 7) of 3 discharged patient records reviewed. The patient record did not contain a completed discharge comprehensive assessment that included all OASIS items. This failure potentially placed the patients at risk of poor health outcomes when ongoing care after discharge was not known. FINDINGS INCLUDE: Patient #5: Review of the discharge record revealed an agency form titled, “DISCHARGE ASSESSMENT” … name of Assessor, Administrator/DON and dated 10/14/2024 on the last page, 22. The form did not contain a comprehensive assessment of the patient’s status on discharge, to include the following data items: Immunization/Vaccines received; Eyes, Ears, Nose, Neck and throat; mouth and head; Musculoskeletal; Pain; Endocrine (network of glands that release hormones into the blood) and Hematopoietic (system that produces blood cells); Integumentary (skin); Vital signs (temperature, blood pressure, pulse and respirations); Respiratory (breathing); Cardiovascular (heart, arteries and veins); Genitourinary (reproduction and elimination of urine); Gastrointestinal (food and liquid digestion); Mental status; Functional ADL status; Falls; Medications; Any emergent care; Any Special Treatments, Procedures and Programs at discharge; the Reason for Discharge and a Summary of care provided during the Home Care episode. The comprehensive assessment at discharge was not completed. Patient #6: Review of the discharge record revealed an agency form titled, “Transferred to an inpatient facility – patient discharged” … name of Assessor, Administrator/DON and dated 09/30/2024 on the last page, 4. On page 2, the form included, “… 3. … This Assessment is Currently Being Completed for the Following Reasons: … Transferred to an inpatient discharged from agencyfacility [sic]—patient. …” The form did not contain an assessment of the patient’s status on discharge, to include the following data items: Vaccines received; Medication Intervention; Patient/Caregiver drug Education Intervention; Emergent Care; Reason for Emergent Care; Intervention Synopsis for Diabetic foot care, Falls Prevention interventions, Depression intervention(s), Intervention(s) to monitor and mitigate pain, Intervention(s) to prevent pressure ulcers and Pressure ulcer treatment based on principles of moist wound healing; Falls; Type of Inpatient Facility where the patient was admitted; Provision of Current Reconciled Medication List to Subsequent (the next) Provider at Transfer; Route of Current Reconciled Medication List Transmission to Subsequent Provider (… verbal, paper-based, fax, email, etc.) and the Date of the transfer. The comprehensive assessment at transfer/discharge was not completed. Patient #7: Review of the discharge record revealed an agency form titled, “DISCHARGE ASSESSMENT” … name of Assessor, Administrator/DON and dated 10/12/2024 on the last page, 22. The form did not contain a comprehensive assessment of the patient’s status on discharge, to include the following data items: Immunization/Vaccines received; Eyes, Ears, Nose, Neck and throat; mouth and head; Musculoskeletal; Pain; Endocrine (network of glands that release hormones into the blood) and Hematopoietic (system that produces blood cells); Integumentary (skin); Vital signs (temperature, blood pressure, pulse and respirations); Respiratory (breathing); Cardiovascular (heart, arteries and veins); Genitourinary (reproduction and elimination of urine); Gastrointestinal (food and liquid digestion); Mental status; Functional ADL status; Falls; Medications; Any emergent care; Any Special Treatments, Procedures and Programs at discharge; the Reason for Discharge and a Summary of care provided during the Home Care episode. The comprehensive assessment at discharge was not completed. In an interview with the Administrator/DON on 01/23/2025 at 3:30 PM, the surveyor reviewed the findings and asked if the discharge assessments for Patient’s #5 and 7 and the Transfer assessment for Patient #6 were completed. The surveyor asked if there was any additional documentation or assessments of discharge for Patient’s #5, 6 and 7. The Administrator/DON stated, “no” and stated the discharges and transfer were not completed. The Administrator/DON stated, “it’s the same answer, I was very overwhelmed, I did the transfer, it was not completed, I didn’t send it (to the facility). I wasn’t doing a good job. It’s a big lesson for me. I trusted (AA) to take care of things.” Agency policy, dated 05/01/2011, quoted in part, “MEDICAL RECORD INFORMATION TIMELINES, IM.10, … POLICY: Agency will ensure timely provision of care and services to meet the patient’s needs in compliance with all federal and state laws and regulations. … PROCEDURE: … 1.9 The Discharge Comprehensive Assessment is completed within 48 hours of the discharge … 4. All medical record information will be incorporated into the patient’s medical record within 14 business days. …” Agency Policy, dated 02/01/2014, quoted in part, “PATIENT DISCHARGE PE.6, … PURPOSE: … To provide for continuity of care as well as appropriate and timely post-discharge care and documentation. … To allow patients to challenge/appeal their provider’s decisions to discharge. … POLICY: … Agency will provide appropriate discharge planning and notification, per regulations. … PROCEDURE: … 2.12 The Discharge Assessment is completed within 48 hours of knowledge of discharge. …””

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element is not met as evidenced by: Based on record review and interviews, the agency failed to ensure wound care treatments were administered only as ordered by a physician or allowed practitioner for 1 (Patient #10) of 1 discharged patient who received wound care treatments from agency staff after discharge. This failure placed Patient #10 at risk of poor care planning, a decline in the wound status, infection and poor outcomes. FINDINGS INCLUDE: Discharge Patient #10: Review of the agency EHR revealed an OASIS D SOC comprehensive assessment, dated 08/05/2024 and included on page 12, “… INTERGUMENTARY [sic] STATUS … Skin … (check marked boxes) Wounds and Ulcers… (wound description) Type: 01 (lesions), Location: buttocks, Size: 3.0 x 2.1 x 3. (length x width x depth), Drainage: serosang (thin, pink fluid from an open wound), Amount: moderate, Odor: no.” On page 22, “name of Assessor: (Administrator/DON). A form titled, “DISCHARGE ASSESSMENT” was dated 10/03/2024 and included on page 22, “name of Assessor: (Administrator/DON). In a phone interview with patient #10 on 01/17/2025 at 11:11 AM, the surveyor asked about the care and services provided by the agency. The patient stated he had been with the agency a long time, including the time with the attendant services. The surveyor asked about the wound care the patient had received. The patient stated he, “had a guy (Alternate Administrator) doing the wound care for about 4 months, then it switched over to (Administrator/DON) and the wound care specialist, Identifier D doctors had been coming out about a month and a half.” The patient stated the (Alternate Administrator) had started doing the wound care in August (2024) and stopped in late October or November (2024) then the Administrator/DON took over the wound care. The surveyor asked if the agency or Administrator/DON had missed any visits or wound care since the end of October/November 2024 until this now (01/17/2025). The patient stated the Administrator/DON never missed (visits) and he would let someone know if that happened. The patient stated his wound care was done even through the holidays (Thanksgiving and Christmas 2024). The wound care nurse (Identifier D) and Administrator/DON had never missed changing the dressings after the Alternate Administrator left (in October 2024) and the Administrator/DON came every Wednesday and Friday. Home visits for wound care were performed after discharge 10/03/2024. On 01/21/2025 at 12:00 PM a review of the EHR revealed no physician’s verbal order for wound care or POC dated after 10/03/2024 for Patient #10. In an interview with the Administrator/DON on 01/21/2025 at 1:15 PM, reviewed the findings and asked if Patient #10 was discharged on 10/03/2024. The Administrator/DON stated, “I did discharge him (Patient #10) and all the patients last year, but I know the paperwork isn’t all done, but I always did the wound care for him. I don’t miss and I still saw him and do the wound care and the other (3 current) patients, I’m a good nurse. For those patients, I couldn’t find anyone (another Home Health Agency) to take them, so I continued to see (visit) them.””