Every finding on record at Paragon Home Health Care Inc

This was a federal complaint survey conducted at a home health agency. This survey was conducted in conjunction with a federal post condition revisit survey, see event ID #5E605-H3 for survey report. Survey Dates: 6/7/2023 and 6/8/2023 Complaint #IN0094846: With related deficiencies cited. Complaint #IN0098981: With related deficiencies cited. Facility ID: 012531 Unduplicated Skilled Census for the past 12 months: 203 Current Census: 23 A condition-level deficiency was cited at 42 CFR §484.58 Discharge Planning.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient had the right to participate in care in 1 of 1 closed record reviewed with care transferred to a urologist (a physician specializing in the care of the urinary tract). (Patient #8) The findings include: Review of an agency policy revised February 2022, titled “Patient Bill of Rights and Responsibilities” stated, “… Patients have the right: … Receive proper written notice … in advance of the Agency reducing or terminating on-going care….” Clinical record review on 6/7/2023, for Patient #8, evidenced an agency document titled “Home Health Discharge Summary” dated 6/1/2023, which indicated the agency discharged the patient on 5/19/2023 to the care of the urologist. Review of agency documents titled “LVN/LPN [licensed vocational nurse/licensed practical nurse] Visit” completed by LPN 1 indicated the patient was alert and oriented to person, place, and time and indicated the patient received discharge notice regarding the plan to discharge to the urologist on document dated 5/3/2023. Review of document dated 5/12/2023 indicated there were no plans to discharge the patient and home care was medically necessary. During an interview on 6/8/2023, at 2:16 PM, Patient #8 indicated she was unaware she had been discharged by the agency. Patient #8 indicated she spoke to the clinical manager the day prior regarding the clinical manager was in India when recertification was due so the clinical manager would come to the patient’s home next week. During an interview initiated on 6/8/2023, at 12:58 PM, LPN 1 indicated he/she did not ever give the patient discharge notice and the clinical manager did not ever discuss plans for patient discharge with LPN 1. LPN 1 indicated he/she did not document discharge notice given to the patient on 5/3/2023. LPN 1 indicated he/she suspected the agency had been changing the documentation on the visit notes in the past and indicated he/she had been pressured by quality assurance (QA) to amend the visit notes in the past. LPN 1 indicated the patient was not appropriate for discharge because the patient needed home care for foley (a plastic tube inserted into the bladder to drain urine) care and monitoring of new intravenous infusion (medication administered into the blood stream though the vein) treatments for rheumatoid arthritis. During an interview on 6/8/2023, at 3:10 PM, the Clinical Manager indicated there was no documented communication with the nurses providing patient care or the urologist regarding the plans to discharge the patient to the urologist’s care.

Advise the patient of discharge for cause CFR(s): 484.50(d)(5)(i) (i) Advise the patient, representative (if any), the physician(s) or allowed practitioner(s), issuing orders for the home health plan of care, and the patient's 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) that a discharge for cause is being considered; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient and the physician responsible for the plan of care were notified that a discharge from the agency was being considered for cause in 1 of 1 closed clinical record reviewed for discharge for cause. (Patient #9) The findings include: Review of an agency policy revised February 2022, titled “Patient Bill of Rights and Responsibilities” stated, “… Patient will be discharged from Agency based on Agency Discharge Criteria Policy: … The patient’s … behavior is disruptive, abusive or uncooperative to the extent that delivery of care to the patient or the ability of the Agency to operate effectively is seriously impaired. The Agency will do the following before it discharges for cause: Advise the patient … the physician(s)/practitioner(s) issuing orders for the home health plan of care and the patient’s primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the Agency (if any) that a discharge for cause is being considered….” Clinical record review on 6/8/2023, for Patient #9, evidenced an agency document titled “Communication Note” completed by Licensed Practical Nurse (LPN) 1 and dated 4/19/2023, which indicated the patient touched the nurse inappropriately with his feet, looked increasingly disheveled, and was noncompliant with medications. Review of an agency document titled “Physician Order” dated 4/19/2023, indicated the patient was discharged from the agency for noncompliance with care. Review failed to evidence any communication with the patient and the physician responsible for the plan of care regarding the consideration of discharge prior to discharge on 4/19/2023. During an interview on 6/8/2023, at 4:09 PM, the Clinical Manager indicated she did not discuss potential discharge with the patient prior to discharging the patient from the agency. The Clinical Manager indicated she sent the patient a text informing him he was discharged from the agency and all wound care would be provided by the wound clinic when the patient called and asked where his nurse was. The Clinical Manager indicated she never did speak with the physician responsible for the plan of care but spoke with the nurse at the wound clinic who said it was fine for the patient to follow-up with the wound clinic and be discharged from the home care agency. The Clinical Manager indicated she did not get a verbal order from the physician for discharge but wrote the order and sent it to the physician for signature.

Make efforts to resolve the problem(s) CFR(s): 484.50(d)(5)(ii) (ii) Make efforts to resolve the problem(s) presented by the patient's behavior, the behavior of other persons in the patient's home, or situation; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to make efforts to resolve the problems presented by the patient’s behavior in 1 of 1 closed clinical record reviewed for discharge for cause. (Patient #9) The findings include: Review of an agency policy revised February 2022, titled “Patient Bill of Rights and Responsibilities” stated, “… Patient will be discharged from Agency based on Agency Discharge Criteria Policy: … The patient’s … behavior is disruptive, abusive or uncooperative to the extent that delivery of care to the patient or the ability of the Agency to operate effectively is seriously impaired. The Agency will do the following before it discharges for cause: ... Make efforts to resolve the problem(s) presented by the patient’s behavior … Document the problem(s) and efforts made to resolve the problem(s) and enter this documentation into its clinical record….” Clinical record review on 6/8/2023, for Patient #9, evidenced an agency document titled “Recertification” completed by the Clinical Manager and dated 4/17/2023, and identified as the comprehensive assessment. Review indicated the patient was non-compliant and had been “making up stories about the nurses and reporting to the wound clinic”, but review failed to evidence re-education to non-compliance and failed to evidence the agency made efforts to resolve the non-compliance and behaviors. Review of agency documents identified as nurse visit notes indicated the nurse documented on visit dated 4/14/2023, tje medications were not filled in the patient’s Medi-planner and documented the patient indicated that was all the medications the patient could afford; indicated the patient demonstrated inappropriate behavior with the nurse; and indicated the patient was noncompliant with elevating the legs as evidenced by worsening leg swelling. Review of visit note dated 4/18/2023, indicated the patient demonstrated inappropriate behaviors with the nurse and was noncompliant with many medications due to the patient’s report of inability to pay for all medications. Review of visit note dated 4/19/2023, indicated the patient demonstrated inappropriate behaviors with the nurse, appeared disheveled and over sedated, and was noncompliant with medication regimen and elevation of legs. Review failed to evidence the agency made efforts to resolve the non-compliance and inappropriate behaviors. Review evidenced an agency document titled “Communication Note” completed by Licensed Practical Nurse (LPN) 1 and dated 4/19/2023, which indicated the patient touched the nurse inappropriately with his feet, looked increasingly disheveled, and was noncompliant with medications. Review of an agency document titled “Physician Order” dated 4/19/2023, indicated the patient was discharged from the agency for noncompliance with care. Review failed to evidence any efforts made by the agency to resolve problems presented by the patient’s behavior prior to discharge. During an interview on 6/8/2023, at 3:49 PM, the Clinical Manager indicated there were no efforts made by the agency or education provided to the patient to resolve the problems presented by the patient’s behavior because there were no other nurses willing to care for the patient.

Provide contact info other services CFR(s): 484.50(d)(5)(iii) (iii) Provide the patient and representative (if any), with contact information for other agencies or providers who may be able to provide care; and This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to provide the patient with contact information for other home care agencies who may be able to provide care in 1 of 1 closed clinical record reviewed for discharge for cause. (Patient #9) The findings include: Review of an agency policy revised February 2022, titled “Patient Bill of Rights and Responsibilities” stated, “… Patient will be discharged from Agency based on Agency Discharge Criteria Policy: … The patient’s … behavior is disruptive, abusive or uncooperative to the extent that delivery of care to the patient or the ability of the Agency to operate effectively is seriously impaired. The Agency will do the following before it discharges for cause: ... Provide the patient and representative (if any), with contact information for other agencies or providers who may be able to provide care….” Clinical record review on 6/8/2023, for Patient #9, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 4/18/2023-6/16/2023, which indicated the agency was to provide skilled nursing services 4 times a week for 9 weeks to provide wound care, complete a head-to-toe physical assessment, and educate the patient on a high-protein diet and on the medication regimen. Review indicated the patient received wound care at the wound clinic 1 time a week.. Review of an agency document titled “Physician Order” dated 4/19/2023, indicated the patient was discharged from the agency for noncompliance with care. Review failed to evidence the agency provided contact information for other agencies who may be able to provide care. During an interview on 6/8/2023, at 3:57 PM, the Clinical Manager indicated the agency did not provide contact information for other agencies willing to provide care because the wound clinic said the patient could go there for wound care. The Clinical Manager indicated there was no documentation from the wound clinic that the wound clinic would provide wound care 4 times a week as ordered in the plan of care. The Clinical Manager indicated she was unsure who would provide the head-to-toe assessment and patient education as ordered in the plan of care.

Discharge Planning CFR(s): 484.58 Condition of Participation: Discharge planning. This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency failed to send all necessary medical information pertaining to the patient’s current course of illness and treatment to the receiving health care practitioner to ensure a safe and effective transition of care (see tag G0564). The cumulative effect of these systemic problems has resulted in the home health agency's inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.58 Discharge Planning. A deficient practice citation was also evidenced at this standard as follows: Based on record review and interview, the agency failed to ensure its policy was followed for discharge planning in 4 of 4 closed clinical records reviewed. (Patient #8, #9, #10, #11) The findings include: 1. Review of an agency policy revised January 2023, titled “Discharge Criteria and Planning” stated, “… The patient is informed of discharge plan at least fifteen (15) calendar days before the services are stopped and acknowledges understanding reason. The evaluation of a patient’s discharge needs and discharge plan must be documented in a timely manner. The evaluation must be included in the medical record and discussed with patient or patient representative. All relevant information from the Agency will be incorporated into the discharge plans to avoid delays. … Physician and other care providers will be informed and knowledgeable of discharge. … The patient’s continuing care needs, if any, are assessed at discharge. … Patients will receive verbal or written instructions….” 2. Review of an agency policy revised February 2021, titled “Reassessments/Update of the Comprehensive Assessment” stated, “… Audio only or two-way audio-video telecommunication can be used for updates to the comprehensive if it is part of the patient’s plan of care. … Minimally, the comprehensive assessment must be updated and revised: … discharged from Agency: within 2 calendar days of the discharge/transfer/death date….” 3. Clinical record review on 6/7/2023, for Patient #8, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 3/21/2023-5/19/2023, which indicated the patient’s diagnoses included, but were not limited to, retention of urine, rheumatoid arthritis (a disease causing painful swelling of the joints), and chronic pain syndrome. Review indicated the agency was to provide skilled nursing services 1 time every other week for 8 weeks for foley catheter (a plastic tube inserted into the bladder to drain urine) management. Review indicated the discharge plan included discharge when patient returned to a stable genitourinary status and caregiver was able to perform foley catheter care. Review indicated the patient’s goals included, but were not limited to, the patient’s pain level would be less than 2 with improved activity level due to effective pain control. Review of an agency document titled “Physician Order” dated 5/3/2023, indicated the skilled nurse was to flush the foley catheter as needed for patency and sediment. Review of agency documents titled “LVN/LPN [licensed vocational nurse/licensed practical nurse] Visit” completed by LPN 1 indicated the patient was starting infusions at the rheumatology office weekly on document dated 5/3/2023 and indicated the patient’s pain was rated at time of the visit a 5 on a scale of 0-10 [0 being no pain and 10 the most severe] with the worst pain reported during the past week at 7 on a scale of 0-10. Review of document dated 5/12/2023, indicated the patient’s worst pain in the past week was a 7 on a scale of 0-10. Review indicated the nurse flushed the foley catheter for mild sediment on documents dated 5/3/2023 and 5/12/2023. Review indicated the patient received discharge notice regarding the plan to discharge to the urologist on document dated 5/3/2023. Review of document dated 5/12/2023, indicated there were no plans to discharge the patient and home care was medically necessary. Review of an agency document titled “Communication Note” completed by LPN 1 and dated 5/12/2023, indicated the patient began new intravenous (administered into the blood stream though a vein) infusions for the treatment of rheumatoid arthritis weekly at the rheumatologist (a physician which treats arthritis and immune-related conditions) office. Review indicated the patient was to undergo a port placement (a medical device implanted under the skin usually in the chest used to draw blood and administer medication) on May 25, 2023. Review indicated the patient had an appointment with the pain physician on June 8, 2023. Review of an agency document titled “Discharge Non-Visit” completed by the Clinical Manager dated 5/19/2023, and identified to be a comprehensive assessment, failed to evidence the comprehensive assessment was completed in-person. Review of the plan of care for certification period 3/21/2023-5/19/2023, failed to evidence audio or video telecommunication could be used for comprehensive assessments. Review failed to evidence the patient was offered and declined an in-person discharge comprehensive assessment. Review failed to evidence the patient’s need for intravenous infusion treatments were assessed. Review indicated the patient had difficulty breathing and failed to evidence an assessment of the patient’s respiratory status. Review failed to evidence an assessment of the patient’s foley catheter and urinary system to include size of catheter, date last changed, patency, appearance of urine, and any signs and symptoms of infection. Review of an agency document titled “Home Health Discharge Summary” dated 6/1/2023, indicated the agency discharged the patient on 5/19/2023, to the care of the urologist (a physician that specializes in conditions affecting the urinary tract). Review failed to evidence the agency communicated with the urologist prior to discharge on what care the urologist was to provide and how often the urologist would provide care. Review failed to evidence the physician responsible for the plan of care was informed of the plan for discharge to the care of the urologist prior to the date of discharge. Review failed to evidence communication regarding the plans of discharge with the rheumatologist and pain physician. Review failed to evidence discharge planning was conducted related to the plan for care for the patient’s upcoming port placement, monitoring of the intravenous infusion treatments, and the patient’s unmet pain goal. During an interview on 6/8/2023, at 3:16 PM, the Clinical Manager indicated the patient’s pain some days was “really bad”. At 3:20 PM, the Clinical Manager indicated Person #6 (urologist) was the physician assuming the care for the patient at time of discharge and indicated the agency did not send the discharge summary to the urologist, rheumatologist, and pain physician. At 3:24 PM, the Clinical Manager indicated the discharge assessment was not completed in person because the Clinical Manager was in India at time of discharge and the discharge assessment was completed based on what she knew of the patient. The Clinical Manager indicated she was not aware of the patient’s intravenous infusion treatments nor about the plan to have a port placed so she did not educate the patient on the signs and symptoms of adverse reactions to the infusion treatments and did not include the infusion treatments in the discharge assessment. The Clinical Manager indicated the assessment of the breath sounds heard in all four lobes must have been a carry-over since the assessment was not completed in person and lung sounds were not assessed. The Clinical Manager indicated the assessment of the foley catheter and urinary system should be included in a comprehensive assessment. 4. Clinical record review on 6/8/2023, for Patient #9, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 4/18/2023-6/16/2023, which indicated the agency was to provide skilled nursing services 4 times a week for 9 weeks for wound care to both lower extremities. Review indicated the patient was treated at the wound clinic 1 time weekly for wound care. Review indicated the discharge plans included the patient would be discharged when the patient was able to provide care per self and when wounds were healed. Review indicated the patient’s rehabilitative potential was fair. Review of agency documents identified as nurse visit notes dated 4/5/2023, 4/6/2023, 4/7/2023, 4/11/2023, 4/12/2023, 4/13/2023, 4/14/2023, and 4/18/2023, indicated discharge was not considered due to lymphedema (tissue swelling), wounds, lack of caregiver support, and patient unable to perform wound care per self. Review of an agency document titled “Recertification” completed by the Clinical Manager and dated 4/17/2023, and identified as the comprehensive assessment, indicated the patient was non-compliant and had been “making up stories about the nurses and reporting to the wound clinic”, but review failed to evidence communication with the patient and physician regarding the non-compliance and failed to evidence the patient and physician were notified of change in discharge plans if non-compliance and behaviors continued. Review evidenced an agency document titled “Communication Note” completed by LPN 1 and dated 4/19/2023, which indicated the patient touched the nurse inappropriately with his feet, looked increasingly disheveled, and was noncompliant with medications. Review of an agency document titled “Physician Order” dated 4/19/2023, indicated the patient was discharged from the agency for noncompliance with care. Review failed to evidence any coordination with the physician and the wound clinic prior to the date of discharge regarding the plans to discharge. Review failed to evidence the agency provided a 15 day notice prior to discharge. Review of an agency document titled “Discharge Non-Visit” completed by the Clinical Manager and dated 4/19/2023, and identified to be a comprehensive assessment, failed to evidence the comprehensive assessment was completed in-person. Review of the plan of care for certification period 4/18/2023-6/16/2023 failed to evidence audio or video telecommunication could be used for comprehensive assessments. Review failed to evidence the patient was offered and declined an in-person discharge comprehensive assessment. Review failed to evidence the agency assessed the patient’s wounds at time of discharge. Review indicated the patient had complaints with the home care nurses leading to the wound clinic questioning the wound care provided by the home care nurses. Review failed to evidence coordination of care with the wound clinic regarding the patient’s complaints and wound clinic’s concerns with the wound care provided by the agency staff. Review indicated the Clinical Manager spoke with the nurse at the office of the physician responsible for the plan of care regarding the patient’s behavior and no nurse willing to make visits to the patient. Review failed to evidence coordination with the wound clinic on the frequency of the wound clinic visits for wound care and failed to evidence the patient was instructed on how often to follow up with the wound clinic. During an interview on 6/8/2023, at 4:09 PM, the Clinical Manager indicated she never did speak with the physician responsible for the plan of care but spoke with the nurse at the physician’s office who indicated it was fine for the patient to follow-up with the wound clinic and be discharged from the home care agency. The Clinical Manager indicated she did not get a verbal order from the physician for discharge but wrote the order and sent it to the physician for signature. The Clinical Manager indicated the discharge comprehensive assessment was not completed in person because no one from the agency wanted to go, and indicated wounds should be included in a comprehensive assessment. The Clinical Manager indicated she was unsure how many times the patient would be seen at the wound care clinic for wound care. The Clinical Manager indicated there were reports from other nurses regarding the patient’s behavior, but there were no plans for discharge discussed with the patient and the physician if the reported behavior continued. The Clinical Manager indicated the agency did not provide the patient a notice prior to discharge and indicated she sent the patient a text message the day of discharge informing the patient the wound clinic would be providing his wound care from now on. The Clinical Manager indicated she did not provide any other discharge instructions to the patient. 5. Clinical record review on 6/7/2023, for Patient #10, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 4/19/2023-6/17/2023, which indicated the patient’s goals included, but were not limited to, patient’s pain would attain effective pain management and have pain less than 3 on a scale of 0-10. Review indicated the discharge plan included, but was not limited to, when patient goals were met. Review indicated the certifying physician was Person #9 (practitioner at the wound clinic) and Person #7 was the primary care physician responsible for the plan of care. Review of agency documents titled “PTA [physical therapy assistant] Visit” completed by the PTA, indicated the patient reported pain of 5 on a scale of 0-10 on documents dated 4/28/2023, and 4/29/2023, 7 on a scale of 0-10 on document dated 5/2/2023, and 6 on a scale of 0-10 on document dated 5/3/2023. Review of document dated 5/3/2023, indicated the PTA discussed discharge for the following week with the patient but failed to evidence the PTA discussed with the physician the need for pain management as evidenced by the report of increased pain by the patient. Review failed to evidence coordination with the pain clinic regarding the patient’s increased pain. Review indicated the visit on 5/3/2023, was the last visit prior to patient discharge on 5/11/2023. Review of an agency document titled “Order for Discharge” dated 5/11/2023, indicated the patient was discharged from the agency effective 5/11/2023, due to the patient reached maximum potential. Review failed to evidence the agency communicated the unmet goals to the physician responsible for the plan of care and the practitioner at the wound clinic to the patient’s increasing pain. During an interview on 4/8/2023, at 2:01 PM, the patient’s caregiver indicated the patient was being treated by Person #9 at a pain clinic and was still having “quite a bit of pain” that affected the patient’s mood, sleep, movement, and activities. The patient’s caregiver indicated Person #9 was the practitioner that referred to home health care for physical therapy for pain management. During an interview on 6/8/2023, at 3:40 PM, the Clinical Manager indicated there was no coordination with the pain clinic and there was no documentation in the clinical record regarding the patient’s pain management need prior to discharge. 6. Clinical record review on 6/8/2023, for Patient #11, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 4/4/2023-6/2/2023, which indicated the agency was to provide skilled nursing services 2 times a week for 9 weeks for wound care to the left buttock. Review indicated the patient lived at an assisted living facility and had a power of attorney. Review indicated the discharge plans included discharging the patient when the wound healed and indicated the rehabilitative potential was good. Review indicated the wound healed on 5/2/2023. Review of an agency document titled “Order for Discharge” dated 5/5/2023, indicated the agency transferred the patient to Entity 8 (hospice agency). Review failed to evidence coordination with the assisted living facility and Entity 8 on the reason for the transfer to hospice. Review failed to evidence communication with the patient and power of attorney regarding the transfer to hospice. Review of an agency document titled “Transfer Summary” and an agency document titled “Transfer Discharge” completed by the Alternate Clinical Manager and dated 5/5/2023, failed to evidence the care was coordinated with the hospice and the assisted living facility. During an interview on 6/8/2023, at 12:05 PM, the Alternate Clinical Manager indicated he was notified by the assisted living facility the patient was transferred to hospice care. The Alternate Clinical Manager indicated he believed the decision to transfer to hospice was made by the patient’s power of attorney and was unsure why the patient was transferred to hospice. During an interview on 6/8/2023, at 3:45 PM, the Clinical Manager indicated there was no documented communication with the assisted living facility and the hospice agency regarding the plans to transfer to hospice. The Clinical Manager indicated she believed the hospice referral came from the assisted living facility. The Clinical Manager indicated there was no documented communication with the patient’s power of attorney regarding the transfer to hospice.

Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to send all necessary medical information pertaining to the patient’s current course of illness and treatment to the receiving health care practitioner to ensure a safe and effective transition of care in 3 of 4 closed records reviewed. (Patient #8, #10, #11) The findings include: 1. Review of an agency policy revised February 2021, titled “Discharge Summary” stated, “… The Discharge Summary will include, but is not limited to: Types of services provided and frequency of services, Patient’s outcomes in meeting goals in the plan of care, Patient/family post-discharge instructions, goals, and treatment preferences, Medications at time of discharge … A Discharge Summary will be sent within 5 business days of patient discharge to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient. … The summary will include all necessary medical information pertaining to the patient’s current course of illness and treatment ….” 2. Review of an agency policy revised February 2021, titled “Transfer/Referral Criteria and Planning” stated, “… Appropriate parties will be informed immediately as the need for transfer becomes evident. This is accomplished by: A written Transfer Summary concerning the Agency’s involvement with the patient, e.g., patient condition at transfer … patient outcomes in meeting goals in the plan of care, instructions/referrals provided to the patient, current reconciled medication list … any continuing symptom management needs … and reasons for transfer or referral will be completed….” 3. Clinical record review on 6/7/2023, for Patient #8, evidenced an agency document titled “Communication Note” completed by the skilled nurse and dated 5/12/2023, which indicated the patient began new intravenous (administered into the blood stream though a vein) infusions for the treatment of rheumatoid arthritis (a disease causing painful swelling of the joints) administered weekly at the office of the rheumatologist (a physician which treats arthritis and immune-related conditions). Review indicated the patient was to undergo a port placement (a medical device implanted under the skin usually in the chest used to draw blood and administer medication) on May 25, 2023. Review indicated the patient had an appointment with the pain physician on June 8, 2023. Review of agency documents titled “LVN/LPN [licensed vocational nurse/licensed practical nurse] Visit” indicated the patient had pain rated 5 on a scale of 0-10 with the worst pain in the past week rated 7 on a scale of 0-10 on document dated 5/3/2023. Review of document dated 5/12/2023, indicated the patient’s worst pain in the past week was rated 7 on a scale of 0-10. Review of an agency document titled “Home Health Discharge Summary” dated 6/1/2023, indicated the agency discharged the patient on 5/19/2023 and indicated current services provided were physical therapy (PT) and occupational therapy (OT). Review failed to evidence the patient was receiving PT and OT services at time of discharge. Review indicated the patient’s goal of pain less than 2 on a scale of 0-10 was met. Review failed to accurately report the patient’s outcome to the pain goal. Review indicated the agency discharged the patient to the care of the urologist (a physician that specializes in conditions affecting the urinary tract). Review indicated the agency sent the discharge summary to the primary care physician on 6/5/2023 but failed to evidence the discharge summary was sent to the urologist, pain physician, and the rheumatologist. During an interview on 6/8/2023, at 3:09 PM, the Clinical Manager indicated the patient received PT and OT services “a long time ago” and should not have been included as current services provided by the agency. At 3:16 PM, the Clinical Manager indicated the patient’s pain some days was “really bad” and indicated on the day of discharge, the patient reported no pain and why the patient’s pain goal was reported as met. At 3:20 PM, the Clinical Manager indicated Person #6 (urologist) was the physician assuming the care for the patient at time of discharge and indicated the agency did not send the discharge summary to the urologist, rheumatologist, and pain physician. 4. Clinical record review on 6/7/2023, for Patient #10, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 4/19/2023-6/17/2023, which indicated the patient’s goals included, but were not limited to, patient’s pain would attain effective pain management and have pain less than 3 on a scale of 0-10. Review indicated the discharge plan included, but was not limited to, when patient goals were met. Review indicated the certifying physician was Person #9 (practitioner at the wound clinic) and Person #7 was the primary care physician responsible for the plan of care. Review of agency documents titled “PTA [physical therapy assistant] Visit” completed by the PTA, indicated the patient reported pain of 5 on a scale of 0-10 on documents dated 4/28/2023 and 4/29/2023, 7 on a scale of 0-10 on document dated 5/2/2023, and 6 on a scale of 0-10 on document dated 5/3/2023. Review indicated the visit on 5/3/2023 was the last visit prior to patient discharge on 5/11/2023. Review of an agency document titled “Home Health Discharge Summary” dated 5/11/2023, indicated the agency discharged the patient due to the patient reached maximum potential. Review indicated the patient’s goal of pain less than 3 on a scale of 0-10 was met. Review failed to accurately report the patient’s outcome to the pain goal. Review indicated the agency sent the discharge summary to the primary care physician but failed to evidence the discharge summary was sent to Person #9 at the pain clinic. During an interview on 4/8/2023, at 2:01 PM, the patient’s caregiver indicated the patient was being treated by Person #9 at a pain clinic and was still having “quite a bit of pain” that affected the patient’s mood, sleep, movement, and activities. The patient’s caregiver indicated Person #9 was the practitioner that referred to home health care for physical therapy for pain management. During an interview on 6/8/2023, at 3:40 PM, the Clinical Manager indicated the discharge summary was not sent to the pain clinic and the discharge summary did not contain documentation regarding the patient’s recent report of pain greater than patient’s goal. 5. Clinical record review on 6/8/2023, for Patient #11, evidenced an agency document titled “Transfer Summary” dated 5/5/2023, which indicated the patient was transferred to Entity 8 (hospice). Review failed to evidence the summary of care provided by the home health agency, significant health history, description of services provided and ongoing needs that cannont be met, and transfer instructions provided to the patient/caregiver. Review failed to evidence the agency sent the transfer summary to Entity 8. During an interview on 6/8/2023, at 3:45 PM, the Clinical Manager indicated the agency should have sent the transfer summary to the hospice agency and the transfer summary should have been completed in its entirety.

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure all orders were recorded in the plan of care in 3 of 4 active clinical records reviewed with wounds. (Patient #1, 2, 7) The findings include: 4. Clinical record review on 6/8/2023, for Patient #7, evidenced documents from Entity #5 (wound clinic) dated 6/5/2023, indicated the treatment for the wound to the coccyx (lower back above the buttocks) was to apply prisma (wound dressing), aquacel silver (an antimicrobial wound dressing), and cover with a foam dressing every 2-3 days. Review of an agency document titled “Home Health Certification and Plan of Care” for certification period 5/12/2023-7/10/2023, failed to evidence the current plan of care included the wound treatment order from 6/5/2023 from the wound clinic. During an order on 6/8/2023, at 4:28 PM, the Clinical Manager indicated the wound clinic orders should be included in the plan of care. 1. Record review evidenced an agency policy revised 2/2022, titled "Plan of Care/CMS #485 and Physician/Practitioner Orders" which stated, "... All patient care orders, including verbal orders, must be recorded in the plan of care ...." 2. Clinical record review for Patient #1 was completed on 6/6/2023, for certification period 5/16/2023 - 7/14/2023. Record review evidenced a skilled nurse visit note dated 5/19/2023, which indicated the patient had a new wound to the right upper extremity. Record review evidenced an order for wound care to the right upper extremity, which was entered on 6/5/2023 (18 days later), and back dated to be effective 5/19/2023. Record review failed to evidence an order for wound care was entered prior to 6/5/2023. During an interview on 6/7/2023, at 12:49 PM, the Clinical Manager indicated the nurse received a verbal order on 5/19/2023, but didn't know they had to enter it in the plan of care as an order until later. 3. Clinical record review for Patient #2 was completed on 6/6/2023, for certification period 5/21/2023 - 7/19/2023. Record review evidenced a skilled nurse visit note dated 5/31/2023, which indicated the physician was notified of INR (blood clotting level) level of 4.5, and orders were given to hold the coumadin (blood thinner) 6/1/2023, and 6/2/2023, and resume daily coumadin on 6/3/2023. Record review failed to evidence any orders for holding coumadin were entered until 6/5/2023 (5 days later). Record review evidenced an order dated 6/5/2023, which indicated effective 6/1/2023, the patient was to hold coumadin on Thursday and Friday, and resume coumadin on Saturday. This order failed to be entered until 6/5/2023. During an interview on 6/7/2023, at 11:28 AM, the Alternate Clinical Manager indicated they received the verbal order to hold coumadin on 5/31/2023, and it was an error that it wasn't entered in the electronic medical record as an order until 6/5/2023.

Development and evaluation of plan of care CFR(s): 484.75(b)(2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); This ELEMENT is not met as evidenced by: Based on record review and interview, the skilled nurse failed to develop and evaluate the plan of care in 1 of 1 active clinical record reviewed with wounds. (Patient #7) The findings include: Review of an agency policy revised February 2021, titled “Nursing Services” stated, “… Professional nursing service will be provided by a registered nurse and include: … Initiating the plan of care and revising as necessary….” Clinical record review on 6/8/2023, for Patient #7, evidenced an agency document titled “Recertification” dated 5/10/2023 and identified as the comprehensive assessment, which indicated the patient had a pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage IV (full thickness skin loss with possible involvement of bone, muscle, or tendon) to the coccyx (lower back above the buttocks). Review of documents from Entity #5 (wound clinic) dated 4/28/2023, indicated the treatment for the wound to the coccyx was to apply prisma (wound dressing), Cuticerin (a lubricant-infused gauze) applied to the exposed bone, aquacel (wound dressing), Qwick (wound dressing), and a border dressing every 3 days. Review indicated wound clinic orders included Juven (nutritional supplement) was to be consumed twice daily. Review of an agency document titled “Home Health Certification and Plan of Care” for certification period 5/12/2023-7/10/2023, which failed to evidence the plan of care included the wound treatment to the coccyx wound and the Juven supplement. During an interview on 6/8/2023, at 4:20 PM, the Clinical Manager indicated the plan of care did not include the wound care orders but the agency nurses followed the wound care clinic’s orders. The Clinical Manager indicated the nurse that developed the plan of care was new and probably overlooked included the wound care orders.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the skilled nurse failed to provide the services as directed in the plan of care in 2 of 3 clinical records reviewed with wounds. (Patient #7, #9) The findings include: 1. Review of an agency policy revised February 2021, titled “Nursing Services” stated, “… Nursing care will be provided in accordance with the patient’s plan of care ….” 2. Clinical record review on 6/8/2023, for Patient #7, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 5/12/2023-7/10/2023, which indicated the skilled nurse was to provide wound care 2 times a week. Review of a document from Entity 5 (wound clinic) dated 5/17/2023, indicated the wound care orders were for the home care to provide wound care 3 times a week during the weeks the patient was not seen at the wound clinic and 2 times a week during the weeks the patient was seen at the wound clinic. Review indicated the patient was to be seen during the wound clinic in 2 weeks (5/31/2023). Review failed to evidence the nurse provided 2 visits for wound care during the week of 5/28/2023. Review evidenced missed visit notes indicated the patient was at a wound clinic appointment on 5/31/2023 and the patient did not answer the door on 6/2/2023. Review failed to evidence the nurse made attempts to reschedule visits to ensure care was provided per the plan of care. During an interview on 6/8/2023, at the Clinical Manager indicated she was unsure why the patient was scheduled for a nurse visit for wound care on the same day as the wound clinic visit and indicated the nurse completed a missed visit for the days the patient was at the wound clinic. The Clinical Manager indicated she was unsure why the skilled nurse did not provide 2 visits per the plan of care during the week of 5/28/2023 and indicated there was no documentation the skilled nurse attempted to reschedule the missed visits with the patient. 3. Clinical record review on 6/8/2023, for Patient #9, indicated an agency document titled “Home Health Certification and Plan of Care” for certification period 2/17/2023-4/17/2023, indicated the patient had wounds to both legs. Review indicated the agency was to notify the physician immediately of any potential problems that impede completion of patient recovery and desired goals. Review of an agency document titled “LVN/LPN [licensed vocational nurse/licensed practical nurse] Visit” dated 4/14/2023, indicated the medications were not filled in the patient’s Medi-planner and the nurse documented the patient indicated that was all the medications the patient could afford; and the patient was noncompliant with elevating the legs as evidenced by worsening leg swelling.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure services were performed in conformance with physician orders in 1 of 2 clinical records reviewed with wounds. (Patient #3) The findings include: Review of an agency policy revised February 2022, titled “Plan of Care – CMS #485 and Physician/Practitioners Orders” stated, “… Care and services provided will be provided according to physician/practitioner orders….” Clinical record review on 5/3/2023, for Patient #3, evidenced a document from Entity #4 (wound clinic) titled “Physician Orders Details” from Person #5 (wound clinic physician) dated 4/27/2023, which indicated the patient had an open area to the left ischium (area of the buttock) with a wound order of a mepilex dressing (a type of wound treatment) to be changed every 2-3 days. Review of agency documents titled “LVN/LPN [licensed vocational nurse/licensed practical nurse] Visit” between 4/28/2023 and 5/3/2023, failed to evidence the nurse changed a treatment to an open area to the left ischium per physician orders. During an interview on 5/8/2023, at 2:07 PM, the Alternate Clinical Manager indicated the wound clinic managed the patient’s wounds and the physician's orders should be followed.

Review and revision of the plan of care CFR(s): 484.60(c) Standard: Review and revision of the plan of care. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure the plans of care were revised and reviewed in 3 of 5 active clinical records reviewed. (Patient #2, #3, #4) The findings include: 1. Clinical record review on 5/3/2023, for Patient #3, evidenced an agency document titled “Physician Order” dated 3/27/2023, which indicated the nurse was to apply a duoderm (an occlusive dressing) to the pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage 1 (a wound with nonblanching reddened, intact skin) to the coccyx (the area above the buttocks) as needed. Review of an agency document titled “SN [skilled nurse] Wound Care Visit” dated 4/5/2023, indicated the area to the upper buttocks/coccyx was healed. Review of agency documents titled “LVN/LPN [licensed vocational nurse/licensed practical nurse] Visit” indicated a wound from moisture damage was noted to the area to the upper buttocks/coccyx and the nurse applied zinc ointment on 4/24/2023. Review of document dated 4/25/2023, indicated the wound to the upper buttocks/coccyx had reopened and had minimal watery drainage. Review of documents dated 4/26/2023 and 4/28/2023, indicated the nurse applied zinc ointment to the wound to the upper buttocks/coccyx. Review evidenced a document from Entity #4 (wound clinic) titled “Physician Orders Details” dated 4/27/2023, which indicated the patient had an open area to the left ischium (area of the buttock) requiring a wound treatment of a mepilex dressing (a type of wound treatment) to be changed every 2-3 days. Review of an agency document titled “Home Health Certification and Plan of Care” for certification period 3/3/2023-5/1/2023, failed to evidence the plan of care was revised by the agency and reviewed by the physician to include the wounds and treatment to the left ischium and to the upper buttocks/coccyx. During an interview on 5/8/2023, at 2:07 PM, the alternate clinical manager indicated the plan of care should have been revised to include the wound treatment to the left ischium and upper buttocks/coccyx. Review of agency documents titled “LVN/LPN Visit” indicated the patient started on a new medication, ofloxacin (an antibiotic), to both ears for 7 days on 4/20/2023. Review failed to evidence the plan of care was updated to include the patient’s new medication. Review of the document dated 4/25/2023, indicated the physician ordered new medications: Ciprofloxacin (antibiotic) and dexamethasone (anti-inflammatory) medications for the ear. Review failed to evidence the plan of care was updated to include the patient’s new medication. During an interview on 5/8/2023, at 2:35 PM, the alternate clinical manager indicated the plan of care should have been updated by contacting the physician responsible for the plan of care to confirm the medication and writing an order to amend the plan of care. The alternate clinical manager indicated there was no order written for the medication and no update to the plan of care. 2. Clinical record review on 5/4/2023, for Patient #4, evidenced agency documents titled “PTA [physical therapy assistant] Visit” dated 4/6/2023, 4/13/2023, 4/17/2023, 4/19/2023, 4/25/2023, 4/27/2023, and 5/2/2023, which indicated the patient had a lidocaine patch (a patch applied to the skin that contains pain relieving medication) to the left knee for pain. Review of agency documents titled “Home Health Certification and Plan of Care” for certification periods 2/11/2023-4/11/2023 and 4/12/2023-6/10/2023, failed to evidence the plan of care was updated to include the patient’s use of a lidocaine patch. During an interview on 5/5/2023, at 2:52 PM, the alternate clinical manager indicated the medication should have been clarified with the physician, a supplemental order for the medication written, and then medication should have been added to the plan of care. 1. Record review evidenced an agency policy revised 02/2022, titled "Plan of Care - CMS #485 and Physician/Practitioner Orders" which stated, "... All patient care orders, including verbal orders, must be recorded in the plan of care. The plan will be revised to reflect any verbal order received during the 60-day certification period so that all Agency staff are working from a current plan ...." 2. Observation of a home visit for Patient #2 was conducted on 5/5/2023, at 12:00 PM, to observe a routine skilled nurse visit. During the visit, the patient was observed to have a wound on their right lower leg, for which the nurse provided wound care. The patient was observed to have a left leg which was wrapped in kerlix and tubigrips. The left leg wound dressing was not removed during the visit. Clinical record review for Patient #2 was completed on 5/8/2023, for certification periods 2/17/2023 - 4/17/2023, and 4/18/2023 - 6/16/2023. Record review evidenced physician orders from Entity #1 (wound clinic), dated 3/28/2023, which indicated the skilled nurse was to apply adaptic (non-adherent wound dressing) to a right lower leg wound. The wound clinic orders indicated the skilled nurse was to visit and perform wound care once weekly every other week, and twice weekly every other week. Record review evidenced a plan of care for certification period 2/17/2023 - 4/17/2023, which indicated the wound care was to be performed on a left leg wound, and failed to include wound treatment orders for a right lower leg wound. The plan of care failed to be revised to include the application of adaptic.The plan of care indicated the skilled nurse was to visit twice weekly, and failed to be revised to reflect the wound clinic orders for alternating visits twice weekly and once weekly. Record review evidenced a plan of care for certification period 4/18/2023 - 6/16/2023, which failed to be revised to include the orders for adaptic to be applied to the right lower leg. The plan of care indicated the skilled nurse was to visit twice weekly, and failed to be revised to reflect the wound clinic orders for alternating visits twice weekly and once weekly. Record review evidenced a skilled nurse visit note dated 4/14/2023, which indicated on 4/10/2023, the patient developed a new left lower extremity wound, which required 7 sutures. The plan of care failed to be revised to reflect any orders for treatment of left lower leg wound. During an interview on 5/8/2023, at 11:46 AM, the Alternate Clinical Manager indicated the plans of care should have been revised to reflect the correct leg, adaptic, and the correct frequency of nursing visits. At 11:51 AM, the Alternate Clinical Manager indicated the plan of care should have been revised to reflect treatment orders for the new wound.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the physician responsible for the plan of care was notified of a new wound in 1 of 2 active clinical records reviewed with wounds. (Patient #3) The findings include: Review of an agency policy revised February 2021, titled "Coordination of Patient Care" stated, "... The Agency must: ... Assure communication with all physicians/practitioners involved in the plan of care ... Staff provides the physician/practitioner with patient information on an ongoing basis regarding: ... Current condition and changes in condition ….” Clinical record review on 5/3/2023, for Patient #3, evidenced a document from Entity #4 (wound clinic) titled “Physician Orders Details” from Person #5 (wound clinic physician) dated 4/27/2023, which indicated the patient had an open wound to the left ischium (area of the buttock) with a wound order of a mepilex dressing (a type of wound treatment) to be changed every 2-3 days. Review failed to evidence the physician responsible for the plan of care was notified of the new wound and wound treatment ordered by the wound clinic physician. During an interview on 5/8/2023, at 2:07 PM, the alternate clinical manager indicated the physician responsible for the plan of care should have been notified of the new wound and treatment orders but had not been notified by the agency.

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the coordination of care with all disciplines and agencies providing services to the patient in 2 of 5 active clinical records reviewed. (Patient #3, #5) The findings include: 1. Review of an agency policy revised February 2021, titled “Coordination of Patient Care” stated, “… The Agency must … Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines….” 2. Clinical record review on 5/3/2023, for Patient #3, evidenced an agency document titled “Recertification” dated 4/30/2023, which indicated the patient’s diagnoses included Multiple Sclerosis (a progressive disease involving the brain and spinal cord) and quadriplegia (paralysis of all 4 limbs). Review indicated the patient was dependent for personal care and activities of daily living, had a foley catheter (a tube inserted into the bladder to drain urine), and had a wound. Review indicated the patient had caregivers coming in the morning and evening to provide care. Review failed to evidence the name of the agency providing the caregivers, the care they were to provide, and the duration of the visits provided. During an interview on 5/8/2023, at 10:20 AM, Licensed Practical Nurse (LPN) #1 indicated the patient was cared for by caregivers from Entity #2. During an interview on 5/8/2023, at 10:45 AM, Person #3 at Entity #2 indicated the patient received 46 hours a week of attendant care services which were provided 2 times a day, 7 days a week and 11 hours a week of homemaker services. Person #3 indicated staff provided from Entity #2 were not allowed to administer any medications or provide wound care. Person #3 indicated she had difficulties with the home care agency nurses instructing the attendants to perform wound care in the absence of the nurse. During an interview on 5/8/2023, at 12:45 PM, the alternate clinical manager indicated he was unaware what agency provided the caregivers and did not know the type of care the patient received from another agency. The alternate clinical manager indicated there was no care coordination with another agency providing services to the patient in the home. Record review of an agency document titled “LVN/LPN [licensed vocational nurse] Visit” completed by LPN #1 and dated 4/17/2023, indicated the morning attendant did not arrive to the patient’s home as scheduled and the LPN had to assist the patient with personal care. Review indicated the patient was going to search for a new attendant care agency due to the reliability issues with the current agency. Review failed to evidence the agency coordinated care with Entity #2 (attendant care agency) regarding the reliability concerns. During an interview on 5/8/2023, at 2:32 PM, the alternate clinical manager indicated the agency should have coordinated care with Entity #2 (attendant care agency) regarding the reliability issues. Review of documents from Entity #4 (wound clinic) indicated the wound to the patient’s right ischium (area of the buttock) measured 0.4 centimeters (cm) in length, 0.6 cm in width, and 1.3 cm in depth on document dated 4/20/2023. Review of document dated 4/27/2023 indicated the wound to the right ischium measured 0.2 cm in length, 0.2 cm in width, and 0.1 cm in depth. Review of agency documents titled “LVN/LPN Visit” dated 4/5/2023 through 5/5/2023, indicated the wound to the right ischium measured 1.4 cm in length, 0.6 cm in width, and 0.4 cm in depth. Review failed to evidence coordination with the wound clinic regarding the discrepancy between wound measurements. During an interview on 5/8/2023, at 2:40 PM, the alternate clinical manager indicated there was no coordination of care with the wound clinic other than the wound clinic’s visit notes regarding the wound measurements. 3. Clinical record review on 5/4/2023, for Patient #5, evidenced agency documents titled “Missed Visit” dated 4/6/2023, 4/19/2023, and 4/21/2023, which indicated the physical therapy assistant (PTA) was unable to provide the visit. Review of document dated 4/6/2023, indicated the patient was treated in the emergency room. Review failed to evidence the PTA coordinated care with the physical therapist regarding the patient’s emergency room visit. Review of documents dated 4/19/2023 and 4/21/2023, failed to evidence the PTA coordinated care regarding the missed visits and the failure to meet the ordered frequency as directed in the plan of care. During an interview on 5/5/2023, at 1:40 PM, the alternate clinical manager indicated staff was educated they should communicate missed visits to the supervising discipline for each patient. The alternate clinical manager indicated there was no documentation the PTA notified the physical therapist. During an interview on 5/5/2023, at 1:53 PM, the alternate administrator indicated the PTA should have notified everyone involved in the patient’s care of the emergency room visit. The alternate administrator indicated the agency was unaware of the emergency visit.

Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure licensed practical nurses were supervised by registered nurses in 2 of 2 clinical records reviewed, which received services from licensed practical nurses. (Patient #2, #3) The findings include: 4. Clinical record review on 5/3/2023, for Patient #3, evidenced agency documents titled “LVN/LPN Visit” dated 4/17/20223, 4/18/2023, and 4/19/2023 which indicated the LPN applied nystatin (an antifungal medication) to the patient’s groin area. Review of an agency document titled “Home Health Certification and Plan of Care” for certification period 3/3/2023-5/1/2023, failed to evidence nystatin was included in the patient’s medication orders. Review failed to evidence the RN provided supervision of the LPN to ensure the LPN was providing care as directed by the plan of care. During an interview on 5/3/2023, at 12:54 PM, the alternate clinical manager indicated there were no supervision visits of the LPN and indicated the RN should provide a supervision visit of the LPN every 30 days. 1. Record review evidenced an agency policy revised 03/2018, titled "Supervision of Staff" which stated, "... The skilled nursing and other therapeutic services furnished will be under the supervision and direction of a physician or RN [registered nurse] ...." 2. Record review evidenced an undated agency policy obtained on 5/8/2023, titled “Wound Care Policy” which stated, “… Clinicians must obtain new wound care orders from MD [physician] if wound care orders are not followed according to plan of care or most recent MD order … Clinicians are responsible for wound measurements every seven days ….” 2. Observation of a home visit for Patient #2 was conducted on 5/5/2023, at 12:00 PM, to observe a routine skilled nurse visit. During the visit the licensed practical nurse performed wound care to a right lower leg wound as follows: cleansed with normal saline, applied hydrofera blue (antibacterial absorbent dressing), applied 4x4 gauze, wrapped with kerlix (gauze wrap), and applied tubigrips (compression stockinette). During the visit, the licensed practical nurse indicated the ABD (absorbent dressing) was not applied because it would put too much pressure on the wound. Clinical record review for Patient #2 was completed on 5/8/2023. Record review evidenced a plan of care for certification period 4/18/2023 - 6/16/2023, which included the following wound care to the right lower leg: cleanse with normal saline, apply hydrofera blue, apply ABD (absorbent dressing), wrap with kerlix, and apply tubigrips. Record review evidenced a licensed practical nurse visit note dated 5/5/2023, which failed to indicate the physician or clinical manager was notified of the ABD not being applied during the visit. Record review evidenced a licensed practical nurse supervisory visit completed by the registered nurse on 4/17/2023, which indicated the licensed practical nurse was following the plan of care for tasks assigned, reporting changes in patient's needs and condition, and no changes to the plan of care were required. Record review evidenced a plan of care for certification period 2/17/2023 - 4/17/2023, which indicated the skilled nurse was to visit twice weekly, and educate the patient on possible drug interactions, importance of wound care, disease process, signs and symptoms of worsening disease process, notification of the physician, wound care to prevent infection, anticoagulant management, fall prevention, storage of wound supplies, wound care, and standard precautions. Record review evidenced missed licensed practical nurse visit notes dated 4/11/2023, and 4/25/2023, which indicated the patient had missed visits, but failed to document which physician was notified, how the physician was notified, results of the communication or on what day or time the physician was notified. Record review evidenced a skilled nurse visit note dated 4/14/2023, which indicated the licensed practical nurse educated the patient on high blood pressure, but failed to educate the patient about possible drug interactions, importance of wound care, disease process, signs and symptoms of worsening disease process, notification of the physician, wound care to prevent infection, anticoagulant management, fall prevention, storage of wound supplies, wound care, and standard precautions, as ordered on the plan of care. This visit note indicated the patient had developed a new wound to the left leg, but failed to include care coordination with the registered nurse or physician. Record review evidenced licensed practical nurse visit notes dated 4/14/2023, 4/18/2023, 4/21/2023, and 4/25/2023, which indicated the patient had 3 wounds, right lower leg, left upper chest, and left lower leg. These visit notes indicated wound care was performed, but failed to include which wound(s) were treated with wound care. Record review evidenced a visit note dated 3/28/2023, from Entity #1 (wound clinic) which indicated the patient's right lower leg wound measured 7cm (centimeters) x 6.5 cm x 0.1 cm. Record review evidenced licensed practical nurse visit notes dated 4/14/2023, 4/18/2023, and 4/21/2023, which all indicated the patient's right lower leg wound measured 7cm (centimeters) x 6.5cm x 0.1cm. Record review evidenced a visit note dated 4/25, from Entity #1 (wound clinic), which indicated the patient's right lower leg wound measured 4cm x 3.2cm x 0.1cm. Record review evidenced licensed practical nurse visit notes dated 4/28/2023, 5/2/2023, and 5/5/2023, which all indicated the patient's right lower leg wound measured 4cm x 3.2cm x 0.1cm. During an interview on 5/3/2023, at 11:23 AM, the Clinical Manager indicated that licensed practical nurses were supervised during supervisory visits every 30 days. During an interview on 5/5/2023, at 2:07 PM, the Alternate Clinical Manager indicated that the registered nurse should have been supervising the licensed practical nurses by reviewing the visit notes. During an interview on 5/8/2023, at 11:47 AM, the Alternate Clinical Manager indicated the visit notes didn't specify which wound was treated with wound care. At 11:52 AM, the Alternate Clinical Manager indicated the missed visit notes should have included which physician was notified, what day and time they were notified, and results of the notification. At 12:02 PM, the Alternate Clinical Manager indicated the wound measurements automatically populated in the visit notes, and wounds were only measured on the first visit of the week. The Alternate Clinical Manager indicated the care performed should have been as ordered on the plan of care. During an interview on 5/8/2023, at 3:17 PM, Licensed Practical Nurse #2 indicated they had been seeing Patient #2, and would use the wound clinic measurements for documentation if they were close to the actual measurements they obtained during the visit.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the Registered Nurse (RN) conducted a review of all medications, and/or major drug-drug interactions which were reported to the physician in 5 of 9 clinical records reviewed (Patient #3, 5, 6, 8, 9). The findings include: 1. Record review evidenced an agency policy revised 1/2023, titled “Medication Reconciliation” which stated, “… The agency will reconcile patient’s medication at time of admission and on an ongoing basis in order to identify any potential adverse effects and drug reactions, including … significant drug interactions … Any concerns or discrepancies will be reconciled by a registered nurse with the patient’s physician/practitioner … In therapy only cases, the therapist submits a list of medications collected during the comprehensive assessment to registered nurse for review, who contacts physician/practitioner if indicated ….” 2. Clinical record review for Patient #5 was completed on 2/28/2023, for certification period 2/17/2023 – 4/17/2023. Record review evidenced a recertification assessment dated 2/13/2023, which indicated the nurse completed the medication regime review, and identified a major drug interaction between diltiazem (to help with irregular heart rate and blood pressure) and acetaminophen-oxycodone (for pain). The recertification assessment failed to evidence the physician was notified of the major drug interaction. During an interview on 2/24/2023, at 3:18 PM, the Clinical Manager indicated the physician should have been notified of the major drug interaction. 3. Clinical record review for Patient #6 was completed on 2/28/2023, for certification period 2/20/2023 – 4/20/2023. Record review evidenced a recertification assessment dated 2/17/2023, which indicated the physical therapist completed the medication reconciliation and review for interactions. Record review failed to evidence the medications were reviewed by a registered nurse. During an interview on 2/27/2023, at 1:19 PM, the Clinical Manager indicated the therapist should have contacted the Clinical Manager, and a registered nurse should have reviewed the list of medications. 4. Clinical record review for Patient #8 was completed on 2/28/2023, for certification period 12/22/2022 – 2/19/2023, discharged 2/16/2023. Record review evidenced a discharge comprehensive assessment dated 2/16/2023, which indicated the physical therapist completed the medication reconciliation and review. Record review failed to evidence the medications were reviewed by a registered nurse. 5. Clinical record review for Patient #9 was completed on 2/28/2023, for certification period 12/13/2022 – 2/10/2023, discharged 2/9/2023. Record review evidenced a discharge comprehensive assessment dated 2/9/2023, which indicated the physical therapist completed the medication reconciliation and review. Record review failed to evidence the medications were reviewed by a registered nurse. During an interview on 2/28/2023, at 10:56 AM, the Clinical Manager indicated the registered nurse should have reviewed the medications during the comprehensive assessments. 410 IAC 17-14-1(a)(1)(B) 7. Clinical record review for Patient #2 was completed on 2/27/23 (start of care date 2/08/23). Record review evidenced a recertification assessment dated 2/08/2023, the registered nurse completed a drug regime review, and found potentially clinically significant medication issues. The document failed to evidence which drugs had potential for clinically significant medication issues, or the the physician was notified of the specific drugs that had potential for clinically significant medication issues. Record review evidenced a plan of care for certification period 2/08/23 – 4/08/23, which failed to evidence which drugs had potential for clinically significant medication issues, or the the physician was notified of the specific drugs that had potential for clinically significant medication issues. During an interview on 2/27/23 at 1:50 PM, the Clinical Manager indicated documentation should include the date, time, and who the clinician spoke to. 8. Clinical record review for Patient #3 was completed on 2/28/2023 (start of care date 10/07/22). Record review evidenced a recertification assessment dated 2/03/2023, the registered nurse completed a drug regime review, and found potential adverse effects/drug reactions/significant drug interactions. The document failed to evidence which drugs had potential for major drug interaction(s), or the date/time the physician was notified. Record review evidenced a plan of care for certification period 2/04/23 – 4/04/23, which failed to evidence which drugs had potential for major drug interaction(s), or the date/time the physician was notified. During an interview on 2/28/2023 at 11:20 AM, the Clinical Manager indicated she didn't know which drugs had the potential for interaction(s), the date/time the physician was notified should be documented, and the specific drugs with potential for major drug interaction(s) should be documented. 2. Record review evidenced an agency policy revised February 2021, titled "medication Monitoring", stated, "... Findings, conclusions ... are documented and communicated to the physician/practitioner ...."

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 observation, record review, and interview, the home health agency failed to ensure services and treatments were administered only as ordered by the physician in 5 of 7 clinical records reviewed (Patient #1, 2, 3, 5, 6). The findings include: 2. Clinical record review for Patient #2 was completed on 2/27/23 (start of care date 2/08/23). Record review evidenced a Registered Nurse (RN) completed the initial comprehensive assessment. Record review evidenced the referral documentation indicated the patient was a "therapy only" case (Physical Therapy [PT]). Record review evidenced a plan of care, which failed to evidence skilled nursing was ordered. During an interview on 2/27/23 at 1:50 PM, the Clinical Manager indicated PT didn't usually do the start of cares (initial comprehensive assessments), and the plan of care should include orders for nursing with frequencies, interventions and goals if a RN saw the patient. 1. Record review evidenced an agency policy updated 1/2023, titled “Plan of Care – CMS #485 and Physician/Practitioner Orders” which stated, “… Drugs, services and treatments are administered by staff only as ordered by physician/practitioner ….” 2. Clinical record review for Patient #6 was completed on 2/28/2023, for certification period 12/22/2022 – 2/19/2023. Record review evidenced a physician order dated 1/30/2023, which indicated the patient was to receive skilled nursing visits 3 times weekly. Record review evidenced a plan of care for certification period 12/22/2022 – 2/19/2023, which did not include any interventions for the skilled nurse to perform. The plan of care indicated the patient was to receive home health aide visits twice weekly, but failed to include any instructions or interventions regarding tasks for the home health aide to perform. Record review evidenced a skilled nurse visit note dated 2/3/2023, which indicated the skilled nurse performed medication box set up with no order. This note indicated the skilled nurse wrapped the patient’s legs with kerlix (gauze wrap) and covered with an ACE bandage (compression wrap), with no orders. Record review evidenced a home health aide visit note dated 2/6/2023, which indicated the home health aide performed the following tasks with no order: shower, shampoo, skin care, peri care, assist with dressing, housekeeping, assist with transfer/ambulation, range of motion, and equipment care. Record review evidenced a skilled nurse visit note dated 2/8/2023, which indicated the skilled nurse performed medication pill box set up with no order. This note indicated the skilled nurse wrapped the patient’s legs with kerlix (gauze wrap) and covered with an ACE bandage (compression wrap), with no orders. Record review evidenced a home health aide visit note dated 2/10/2023, which indicated the home health aide performed the following tasks with no order: shower, shampoo, skin care, peri care, assist with dressing, housekeeping, assist with transfer/ambulation, range of motion, and equipment care. During an interview on 2/27/2023, at 1:30 PM, the Clinical Manager indicated the home health aide and skilled nurses should have performed treatments only as ordered on the plan of care. The Clinical Manager indicated the home health aide care plan was included on the plan of care. The Clinical Manager indicated there were no orders to perform medication set-up, wrap the patients legs, or perform the tasks the home health aide performed.

Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient's updated comprehensive assessment, and contain information concerning the patient's progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the revised plans of care included information concerning the patients’ progress toward measurable outcomes and goals identified on the plan of care in 4 of 4 clinical records reviewed with patients who received services greater than 60 days (Patient #3, 5, 6, 7). The findings include: 2. Clinical record review for Patient #3 was completed on 2/28/2023 (start of care date 10/07/22). Record review evidenced a plan of care for certification period 2/04/23 – 4/04/23, which failed to evidence the patient’s progress towards measurable outcomes and goals identified on the plan of care. During an interview on 2/28/2023 at 11:20 AM, the Clinical Manager indicated the plan of care didn't include the patient's progress toward goals, it should be included on the plan of care, and it might be on an addendum to the plan of care. Upon survey exit, nothing further was submitted for review. 1. Record review evidenced an agency policy revised 1/2023, titled “Plan of Care – CMS #485 and Physician/Practitioner Orders” which stated, “… Recertification requirements include: … The individualized plan of care must be reviewed and revised by the physician/practitioner who is responsible for the home health plan of care and the Agency … no less frequently than once every 60 days … A revised plan of care must reflect current information from the patient’s updated comprehensive assessment, and contain information concerning the patient’s progress toward the measurable outcomes and goals identified by the Agency and patient in the plan of care ….” 2. Clinical record review for Patient #5 was completed on 2/28/2023, for certification period 2/17/2023 – 4/17/2023, start of care date 12/19/2022. Record review evidenced a plan of care for certification period 2/17/2023 – 4/17/2023, which failed to include information concerning the patient’s progress towards measurable outcomes and goals identified on the plan of care. During an interview on 2/24/2023, at 1:56 PM, the Clinical Manager indicated the revised plans of care should have included progress towards identified goals. 3. Clinical record review for Patient #6 was completed on 2/28/2023, for certification period 2/20/2023 – 4/20/2023, start of care date 12/22/2022. Record review evidenced a plan of care for certification period 2/20/2023 – 4/20/2023, which failed to include information concerning the patient’s progress towards measurable outcomes and goals identified on the plan of care. 4. Clinical record review for Patient #7 was completed on 2/28/2023, for certification periods 12/17/2022 – 2/14/2023, and 2/15/2023 – 4/15/2023, start of care date 12/22/2021. Record review evidenced a plan of care for certification period 12/17/2022 – 2/14/2023, which failed to include information concerning the patient’s progress towards measurable outcomes and goals identified on the plan of care. Record review evidenced a plan of care for certification period 2/15/2023 – 4/15/2023, which failed to include information concerning the patient’s progress towards measurable outcomes and goals identified on the plan of care.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure registered nurses completed clinical notes in a timely and/or accurate manner in 9 of 9 clinical records reviewed (Patient #1, 2, 3, 4, 5, 6, 7, 8, 9). The findings include: 1. Record review evidenced an agency policy revised 1/2023, titled “Timely Submission of Patient Documentation” which stated, “… Itineraries, with all visit reports attached, must be submitted the next scheduled work day, not exceeding three business days ….” 2. Record review evidenced an agency policy revised 1/2023, titled “Medical Record Entries and Authentication” which stated, “… All entries in patient records will be legible, clear, complete, and appropriately authenticated, dated and timed ….” 3. Record review evidenced an agency policy revised 1/2023, titled “Skilled Professional Services” which stated, “… Skilled professionals must assume responsibility for, but not be restricted to the following: … Preparing clinical notes ….” 4. Clinical record review for patient #5 was completed on 2/28/2023, for certification period 2/17/2023 – 4/17/2023. Review of the electronic medical record on 2/22/2023, at 2:38 PM, evidenced a recertification assessment was scheduled for 2/13/2023, but was not completed or documented (10 days later). Review of the electronic medical record on 2/23/2023, at 1:23 PM, evidenced the recertification assessment was now completed (11 days later). Record review evidenced a recertification assessment which was dated 2/13/2023, and indicated it had been electronically signed by the registered nurse on 2/13/2023. This assessment indicated the patient had no swelling to lower extremeties. This assessment indicated the patient had wounds to both legs, but failed to include any measurements in the assessment. Record review evidenced wound clinic notes dated 2/13/2023, which indicated the patient was receiving compression wraps to both legs due to swelling. Record review evidenced skilled nurse visit notes dated 2/2/2023, 2/6/2023, 2/7/2023, and 2/9/2023, which indicated care was coordinated with the physician, but failed to include which physician, when the communication occurred, or what was communicated. During an interview on 2/24/2023, at 2:23 PM, the Clinical Manager indicated the clinicians should have signed documentation on the day that they completed the documentation. At 3:03 PM, the Clinical Manager indicated the skilled professional should have documented what information was communicated to the doctor, results of the communication, and which doctor was called or communicated with. At 3:16 PM, the Clinical Manger indicated the recertification assessment should have included swelling to the legs. The Clinical Manager indicated the recertification assessment should have included wound measurements. 5. Clinical record review for Patient #6 was completed on 2/28/2023, for certification periods 12/22/2022 – 2/19/2023, and 2/20/2023 – 4/20/2023. Record review evidenced skilled nurse visit notes dated 2/3/2023, 2/8/2023, and 2/10/2023, which indicated the patient had pitting edema (swelling which when pressed, causes an indentation in the skin), but failed to document the grade of pitting edema. Review of the electronic medical record on 2/22/2023, at 10:43 AM, evidenced a recertification assessment was scheduled for 2/17/2023, but was not completed or documented (5 days after scheduled assessment). Record review evidenced a payroll documentation sheet for the Alternate Clinical Manager, which indicated the recertification assessment had been conducted on 2/14/2023. Review of the electronic medical record on 2/24/2023, at 10:33 AM, evidenced the recertification assessment was saved, but not completed (11 days after the assessment was conducted). Record review evidenced the recertification assessment, which indicated the visit date was 2/17/2023, and was electronically signed by the Alternate Clinical Manager on 2/14/2023. During an interview on 2/22/2023, at 11:37 AM, the Alternate Clinical Manager indicated the recertification visit was completed on 2/14/2023, and was not completed or documented yet. During an interview on 2/27/2023, at 12:54 PM, the Clinical Manager indicated maybe the note was signed on 2/14/2023 because that was the day of the visit. The Clinical Manager did not know why the recertification assessment was dated 2/17/2023, and signed on 2/14/2023. The Clinical Manager did not know why the recertification assessment was not documented for 11 days after the visit. The Clinical Manager indicated documentation should have been completed within 5 days of the visit, and signed on the day it was completed. At 1:28 PM, the Clinical Manager indicated the nurses should have documented the grade of edema, if there was any weeping, the color of the legs, and if the edema was pitting or non-pitting. 6. Clinical record review for Patient #7 was completed on 2/28/2023, for certification periods 12/17/2022 – 2/14/2023, and 2/15/2023 – 4/15/2023. Record review evidenced skilled nurse visit notes dated 1/31/2023, 2/7/2023, and 2/21/2023, which all indicated the patient’s wound measured 2.5 cm (centimeters) x 2.5cm x 0.1cm. Record review evidenced a recertification assessment dated 2/14/2023, which indicated the patient’s wound measured 4cm x 4cm x .1cm. During an interview on 2/28/2023, at 10:49 AM, the Clinical Manger indicated the documentation looked like the nurses were not measuring the patient’s wound on visits 1/31/2023, 2/7/2023, and 2/21/2023. 7. Clinical record review for Patient #8 was completed on 2/28/2023, for certification period 12/22/2022 – 2/19/2023, discharged 2/16/2023. Record review evidenced a discharge comprehensive assessment dated 2/16/2023, which failed to include an assessment of psychosocial status. This document failed to include an assessment of cardiac or respiratory status, including heart sounds and lung sounds. This document indicated the patient had swelling to lower extremities but failed to include how much edema the patient had. During an interview on 2/28/2023, at 11:01 AM, the Clinical Manager indicated the comprehensive discharge assessment should have included a psychosocial assessment, grade of swelling, and lung and heart sound assessment. 8. Clinical record review for Patient #9 was completed on 2/28/2023, for certification period 12/13/2022 – 2/10/2023, discharged 2/9/2023. Record review evidenced a discharge comprehensive assessment dated 2/9/2023, which failed to include a psychosocial assessment. This document failed to include an assessment of cardiac or respiratory status, including heart sounds and lung sounds. 4. Clinical record review for Patient #1 was completed on 2/24/23 (start of care date 2/17/23). Review of the electronic medical record (EMR) on 2/22/23 at 4:04 PM failed to evidence a completed plan of care for certification period 2/17/23 – 4/17/23. Review of the EMR on 2/22/23 evidenced an initial evaluation/comprehensive assessment was scheduled for 2/17/23, and stated, “... Not yet started ....” Record review of the initial comprehensive assessment received on 2/24/2023, dated 2/17/2023, evidenced the patient had poor mobility, lived alone, was alert and oriented to person, place, and time, but was rarely/never able to be understood, needed help from another person to complete personal care (grooming, bathing, dressing, toileting), and was able to walk only with assistance of another person at all times. During an interview on 2/22/2023 at 4:44 PM, the Clinical Manager confirmed there was no completed initial evaluation/comprehensive assessment or plan of care in the EMR. During an interview on 2/24/23 at 2:20 PM, the Administrator confirmed the initial evaluation/comprehensive assessment wasn’t completed in the EMR until 2/23/23 at 9:06 PM, and the plan of care wasn’t created/completed until this morning (2/24/23) at 9:04 AM. During an interview on 2/24/2023 at 3:07 PM, the Alternate Clinical Manager indicated the patient was independent in the home, she didn't need additional human assist for personal care/walking, she was always able to be understood, and in reference to the comprehensive assessment, the Alternate Clinical Manager stated, "... Those are errors ... She’s independent ... There’s no way I would have checked t[those things] ... There’s no way ... That is really weird ...." 5. A home visit was observed on 2/24/23 at 11:00 AM with Patient #2 and Physical Therapy Assistant (PTA) #4. The patient indicated he didn’t know what to expect after a total knee replacement, he had a dressing over his incision when he got home, he got home at the end of January (2023), and he was told by the surgeon that he could take the dressing off after a couple of days. The patient indicated after a couple of days, he removed the surgical dressing and covered the incision with gauze for an additional few days. The patient indicated he was supposed to watch the amount of sugar and carbs he consumed. Clinical record review for Patient #2 was completed on 2/27/23 (start of care date 2/08/23). Review of the EMR on 2/22/23 at 4:07 PM evidenced a plan of care and initial comprehensive assessment, but failed to evidence they were completed (14 days after start of care). Review of the EMR on 2/23/23 at 2:05 PM evidenced the plan of care and initial comprehensive assessment were now completed. Record review on 2/27/2023 evidenced an initial comprehensive assessment dated 2/08/2023, which indicated the patient had no wounds or surgical incisions, and was on a regular diet (no dietary restrictions). The document failed to evidence the patient had an incision on his right knee, or diet was carb and sugar restricted. The document was electronically signed by the nurse 2/08/2023, but the document wasn't completed until 2/23/2023. Record review on 2/27/2023 evidenced a plan of care for certification period 2/08/23 – 4/08/23, which failed to evidence the correct diet the patient was supposed to follow. During an interview on 2/22/23 at 4:29 PM, the Clinical Manager confirmed there wasn't a completed plan of care or initial comprehensive for Patient #2. During an interview on 2/27/2023 at 1:50 PM, the Clinical Manager indicated she expected to see assessment of the patient's knee incision. 6. Clinical record review for Patient #3 was completed on 2/28/2023 (start of care date 10/07/22). Review of the EMR on 2/23/23 at 10:38 AM failed to evidence a completed plan of care for certification period 2/04/23 – 4/04/23 (19 days after the certification period began). During an interview on 2/28/2023 at 11:20 AM, the Clinical Manager indicated the plan of care wasn't complete, and it was still in progress. 7. Clinical record review for Patient #4 was completed on 2/28/2023 (start of care date 2/13/23). Record review evidenced a referral for home care services was received by the agency on 2/02/23, to occur “ASAP”, the patient needed at least placement at an assisted living facility (ALF), possibly with a locked unit due to dementia (conditions characterized by impairment of at least two brain functions, such as memory loss and judgment. Symptoms include forgetfulness, limited social skills, and thinking abilities so impaired that it interferes with daily functioning), and Adult Protective Services (APS) was involved due to the question of the patient’s safety and inability to independently take his medications. Review of the EMR on 2/23/23 at 11:18 AM, failed to evidence the plan of care was completed for certification period 2/13/23 – 4/13/23 (10 days after start of care). Record review on 2/28/2023 evidenced a plan of care for certification period 2/13/23 – 4/13/23, which evidenced medical necessity for home care services included identified knowledge deficit regarding medication regimen management, the patient was unable to to perform accurate insulin administration and had no willing or able caregiver to perform insulin administration; and the patient had dementia. Record review evidenced an initial comprehensive assessment dated 2/13/2023. The document evidenced the patient was oriented to person, place, and time, but was forgetful; was able to take medications at the correct times if prepared in advance by another person (or) another person developed a drug diary or chart; and was able to independently take the correct injectable insulin medication and proper dosages at the correct times. The document was inaccurate based on the findings on the plan of care. During an interview on 2/28/2023 at 12:04 PM, the Clinical Manager indicated the patient wasn't managing any of his medications, he didn’t know how to check his blood sugar, and they (agency nurses) didn't know if he was taking the correct amount of medications, or if it was taken at the correct times, and indicated the patient wasn't safe to be home alone. The Clinical Manager indicated the plan of care wasn't considered completed until after it was reviewed and approved. ** During an interview on 2/23/2023 at 2:47 PM, the Administrator indicated employees had a week to turn in their clinical documentation or complete them in the EMR, he indicated he was sure of this, and declined to provide a response as to what the agency's own policy stated for the timeframe employees were required to submit clinical documents.

This was a Federal complaint survey conducted at Paragon Home Health Care Inc., a deemed home heath agency, by the Indiana Department of Health (IDOH). Complaint # 94384: substantiated with Federal deficiencies Survey Dates: November 30 (2022), December 1, 2, 5, 6, 7, 8, 9 (2022) Facility ID: 012531 Current Census: 56 Based on the Condition-level deficiencies cited at 42 CFR §484.55 Condition of Participation: Comprehensive Assessment of Patients, 42 CFR §484.60 Condition of Participation: Care Planning, Coordination of Services, and Quality of Care; 42 CFR §484.70 Condition of Participation: Infection Prevention and Control, 42 CFR §484.105 Condition of participation: Organization and Administration of Services, and 42 CFR §484.110 Condition of participation: Clinical records during the 12/09/22 survey, and pursuant to section 1891(c)(2)(D) of the Social Security Act on 12/09/22, your agency is precluded from operating a home health aide training, skills competency and/or competency evaluation programs for a period of two years beginning 12/09/22 and continuing through 12/08/24. Quality Review Completed 01/19/2023

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, record review, and interview, the Registered Nurse (RN) failed to conduct the initial evaluation within 48 hours of referral to determine eligibility for the Medicare home health benefit, including homebound status (Please see tag G0514); failed to complete a comprehensive assessment including the administration of the OASIS (Outcome and Assessment Information Set) during the last 5 days of every 60 day certification period (Please see tag G0546); failed to ensure a comprehensive assessment was completed for patients who were hospitalized during the certification period (Please see tag G0548); and failed to complete a comprehensive assessment upon discharge (Please see tag G0550). This practice had the potential to affect all patients serviced by the agency. The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care for the Condition of Participation 42 CFR §484.55: Comprehensive Assessment of Patients.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the Registered Nurse (RN) failed to conduct the initial evaluation within 48 hours of referral to determine eligibility for the Medicare home health benefit, including homebound status, for 7 of 8 clinical records reviewed (#1, 2, 3, 4, 5, 6, 7), and 1 of 1 random patient selected who's initial assessment was pending (#9). 1. An agency policy with revised date February 2022, titled "Initial Assessments ....", stated, "... Each patient admitted ... will have appropriate initial assessments performed and documented ... The initial assessment bridges the gap between when the first patient encounter occurs and when the plan of care can be implemented ... "Immediate care and support needs" are those items and services that will maintain the patient's health and safety through this interim period ... until the Agency can complete the comprehensive assessment and implement the plan of care ... A RN [Registered Nurse] ... must conduct the initial assessment visit within 48 hours of referral ... is conducted to determine the immediate care and support needs of the patient ...." 2. An agency policy with revised date February 2021, titled "Patient Admission Criteria", stated, "... When a telephone referral is received by the agency, a referral form is completed by a [sic] RN ... Each referral is evaluated by the Clinical Manager ... to determine the appropriateness of home care ... One home evaluation visit may be made before deciding to accept the patient for home care ... All initial evaluation visits are made by a [sic] RN ...." 3. An agency job description signed by Employee #7 (Referral/Intake Supervisor) and the Administrator on 9/10/18, titled "Referral/Intake Supervisor", stated "... Responsible for managing all aspects of the patient intake process ... Essential Job Functions ... Ensures seamless transition of patients to home care by providing direct oversight of patient education and preparation of home care, plan of care initiation, and coordination of care with multiple service providers ... Position Qualifications ... 1. Registered Nurse with current licensure ... 2. Bachelor's degree in Nursing ...." The document evidenced the position qualifications "1. Registered Nurse with current licensure [and] 2. Bachelor's degree in Nursing" were crossed out and initialed by the Administrator. 4. During an interview on 12/05/22 at 3:00 PM, The Clinical Manager indicated she was not involved with referrals or the intake process, she never saw any paperwork about new referrals until after Employee #7 processed the paperwork, Employee #7 decided if the patients were accepted for care or not, Employee #7 did all the "leg work", Employee #7 told her (the Clinical Manager) when to admit the patient, and the patients were almost always admitted well after the referral dates. When queried if Employee #7 was an RN or licensed practical nurse (LPN), the Clinical Supervisor stated "... No ..." 5. During an interview on 12/06/22 at 11:25 AM, when queried to describe the referral/home care admission process, Employee #7 indicated when she received a referral, she decided if they (the agency) could accept it or not based on the service area and what type of insurance the patient had, and she would let the referring entity/person know if the agency could accept the patient or not; she (Employee #7) would verify the insurance, make sure the agency had all required paperwork, such as the history and physical (H&P), wound orders, or anything like that, and then after that, she entered the referral into the system (electronic medical record [EMR]), notified the RN, called the patient, and set up a time to do the admission for home care services. When queried how quickly an RN saw the patient after a referral was received by the agency, Employee #7 it was supposed to be within 24-48 hours, but it was usually more like a week, it depended on insurance verification and RN availability, and she would call the patient and the doctor's office to let them know when the nurse could go. 6. During an interview on 12/06/22 at 1:37 PM, the Administrator indicated they (agency) didn't need an RN to do the patient "intake part", they had a Clinical Manager that Employee #7 could consult if she needed anything, and Employee #7 processed all referrals. The Clinical Manager indicated she was made aware of patient referrals after everything was ready and insurance was cleared, Employee #7 would send her the patient's information, and then she (the Clinical Manager) would call the patient to schedule the initial/admission visit. The Clinical Manager indicated she did not decide if patients were accepted for services, Employee #7 did. 7. During an interview on 12/06/22 at 1:52 PM, the Administrator indicated it was also the Clinical Manager's responsibility to ensure admissions were performed timely. When queried why the qualification to be an RN was crossed off the job description titled "Referral/Intake Supervisor" signed by the Administrator and Employee #7 on 9/10/18, the Administrator indicated it was because the Referral/Intake Supervisor could work with the Clinical Manager. When queried why the same job description indicated the Referral/Intake Supervisor reported to the Executive Director/Administrator, and not the Clinical Manager, the Administrator stated "... Maybe the Executive Director is the same thing as the DON [Director of Nursing/Clinical Clinical Manager] ....", and indicated he needed to update his policy. 8. During an interview on 12/09/22 at 12:12 PM, Employee #5 (Marketer) indicated Employee #7 was the Intake Coordinator, and Employee #6 (Office Staff) was starting to do that job as well. When queried who decided if a patient was accepted for care, Employee #5 indicated Employee #7 decided. When queried if either Employee #6 or #7 were nurses, Employee #5 stated "No." 9. Clinical record review for Patient #1 was completed on 12/06/22 (Start of care date 10/12/22). A document dated 10/12/22, titled "Start of Care ...." (initial comprehensive assessment) stated, "... Date of Referral ... Indicate the date that the written or verbal referral for initiation ... of care was received by the HHA [home health agency] ... 10/05/22 ...." The initial evaluation/comprehensive assessment occurred 7 days after the agency received the referral for home care services. On 12/06/22, Employee #7 submitted Patient #1's referral documents. A document dated 10/05/22, titled "FAXSHEET", evidenced a referral from Entity #18 was received by the home care agency. An additional document dated 10/05/22, signed by Person #7 (Patient #1's certifying physician), titled "Referral", stated "... Evaluate, consult and treat- home care for skilled nursing ...." During an interview on 12/06/22 at 2:46 PM, the Clinical Supervisor indicated the initial evaluation/comprehensive assessment was late because she didn’t get the the patient's information for the start of care until 10/09/22, and indicated that's always how it happened. 10. Clinical record review for Patient #2 was completed on 12/08/22 (start of care date 8/08/22). A document titled "Home Health Certification and Plan of Care" evidenced the initial evaluation/comprehensive assessment occurred on 8/08/22. The initial evaluation/comprehensive assessment occurred 12 days after the agency received the referral for home care services. On 12/06/22, Employee #7 submitted Patient #2's referral documents. A document dated 7/27/22, titled "[Entity #9, a wound clinic]", evidenced a referral from Entity #9 was received by the home care agency. An additional document dated 7/26/22, signed by Person #19 (Patient #2's certifying physician), titled "Paragon Order ....", stated "... Homecare order to evaluate and treat ... Nursing ...." During an interview on 12/06/22 at 3:11 PM, the Clinical Supervisor indicated she received the patient's information on 8/02/22 (Tuesday), the patient went to wound clinic on 8/04/22 (Thursday), and she did the initial evaluation/comprehensive assessment on 8/08/22 (Monday), and stated "... because I don’t work on Saturdays ...." 11. Clinical record review for Patient #3 was completed on 12/08/22 (start of care date 1/31/22). A document titled "Home Health Certification and Plan of Care" evidenced the initial evaluation/comprehensive assessment occurred on 1/31/22. The initial evaluation/comprehensive assessment occurred 31 days after the agency received the referral for home care services. On 12/06/22, Employee #7 submitted Patient #3's referral documents. A document dated 12/31/21, titled "[Entity #1, a hospital] ... Home Care: Start of Care Orders ....", evidenced the agency received orders for skilled nursing for wound care on 12/31/21. 12. Clinical Record review for Patient #4 was completed on 12/09/22 (start of care date 1/26/22). A document titled "Home Health Certification and Plan of Care" evidenced the initial evaluation/comprehensive assessment occurred on 1/26/22. The initial evaluation/comprehensive assessment occurred 90 days after the agency received the referral for home care services. On 12/06/22, Employee #7 submitted Patient #4's referral documents. A document dated 10/28/21, titled "MD Certification for Patient's ... Home Health Services", evidenced the agency received orders for skilled nursing, home health aide (HHA), physical therapy (PT, and occupational therapy (OT) on 10/28/21. During an interview on 12/06/22 at 1:09 PM, Employee #7 stated, "... the dates will be wrong ....". Employee #7 then indicated when the agency switched to a new electronic medical record (EMR) software "about a year ago", they entered all current patients from that time frame (about a year ago) as new admissions, with altered start of care dates. The administrator indicated they had no access to the records from the previous EMR software. Upon survey exit, no further information was submitted for review. 13. Clinical record review for Patient #5 was completed on 12/09/22 (start of care date 9/06/22). A document titled "Home Health Certification and Plan of Care" evidenced the initial evaluation/comprehensive assessment occurred on 9/06/22. The initial evaluation/comprehensive assessment occurred 25 days after the agency received the referral for home care services. On 12/06/22, Employee #7 submitted Patient #5's referral documents. A document dated 8/12/22, titled "[Person #20, the patient's certifying physician] Medical Clinic ...." evidenced the agency received orders for skilled nursing, PT, and OT on 8/12/22. During an interview on 12/09/22 at 2:26 PM, the alternate Clinical Manager indicated she just started working for the agency, and could not comment on the delay in the initial evaluation/comprehensive assessment. 14. Clinical record review for Patient #6 was completed on 12/08/22. A document titled "Home Health Certification and Plan of Care" evidenced the initial evaluation/comprehensive assessment occurred on 10/07/22. The initial evaluation/comprehensive assessment occurred 3 days after the agency received the referral for home care services. On 12/06/22, Employee #7 submitted Patient #6's referral documents. A document dated 10/4/22, titled "[Entity #1] ... Wound Care ....", evidenced the agency received a referral for home care on 10/04/22, and stated, "... [patient] needs [3 times per week] dressing changes [wound care] ... please start asap [as soon as possible] ...." 15. Clinical record review for patient #7 was completed on 12/09/22 (start of care date 11/09/22). A document titled "Home Health Certification and Plan of Care" evidenced the initial evaluation/comprehensive assessment occurred on 11/09/22. The initial evaluation/comprehensive assessment occurred 14 days after the agency received the referral for home care services. On 12/06/22, Employee #7 submitted Patient #7's referral documents. A document dated 10/26/22, titled "Home Care- Start of Care Orders ....", evidenced the agency received an order for home care on 10/26/22, and the patient required new colostomy (a surgical procedure in which a piece of the colon is diverted to an artificial opening in the abdominal wall so as to bypass a damaged part of the colon) teaching. During an interview on 12/09/22 at 2:30 PM, the Administrator indicated the initial evaluation/comprehensive assessment may have been delayed due to insurance issues, and indicated Employee #7 would know better. Employee #7 indicated it was delayed because of insurance processing. 16. On 12/09/22 at 12:55 PM, observed a phone call in progress with Employee #7, who indicated to the person on the phone that there was no nurse available today (12/09/22) for an admission (Patient #9). During an interview on 12/09/22 at 12:58 PM, administrative Employee #7 indicated family of patient #9 called to see when the nurse was coming out to admit the patient for home care, and she gave family the Clinical Supervisor's number to schedule a time for Monday (12/12/22). On 12/09/22, Employee #7 submitted patient #9's referral documents. A document from Entity #1, dated 12/01/22, titled "Home Care: Start of Care Orders ...." indicated the agency received orders for skilled nursing, PT, and HHA on 12/01/22. An additional document from Entity #1, dated 12/01/22, titled "Home Discharge Instructions", indicated the patient was discharged from entity #1 on 12/01/22, and stated, "... Follow up Instructions ... with ... Paragon Home Care ... Within 1 to 2 days ... Nursing visit for staples removal on Friday 12/09/22 ...." During an interview on 12/09/22 at 1:01 PM, when queried about Patient #9's referral and status of admission, The Administrator indicated he didn't know about it. During an interview on 12/09/22 at 3:49 PM, when queried why Patient #9 wasn't admitted today (or sooner), Employee #7 indicated Patient #9 was never scheduled to begin today, she thought there was a misunderstanding between Employee #6 and Person #2 (family of Patient #9), and Person #2 already scheduled with the Clinical Manager to perform the initial evaluation/comprehensive assessment on Monday (12/12/22). The initial assessment/comprehensive visit was scheduled for 11 days after the agency received the referral. During an interview on 12/09/22 at 4:01 PM, Person #2 indicated Patient #9 got out of the hospital about 2 weeks ago, she called Paragon Home Health Care about 2 days after Patient #9 was discharged from the hospital to get services started, and they (Paragon staff) told her they were waiting on a nurse and paperwork. Person #2 indicated she didn't hear back from Paragon, so she called again about a week later with no results, and called again today (12/09/22). When queried if she requested a delay in the start of home care services, Person #2 indicated they did not, and indicated when she called the Clinical Manager today to schedule the admission nursing visit, the Clinical Manager told her the delay was because they (Paragon Home Health Care) were awaiting until after the patient got her staples out today to begin home health services, and she would be there Monday 12/12/22 at 1:00 PM.

Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the Registered Nurse (RN) failed to complete a comprehensive assessment including the administration of the OASIS (Outcome and Assessment Information Set) during the last 5 days of every 60 day certification period, for 2 of 2 home visits observed with an RN (#2, 6). Findings include: 1. An agency policy, revised date February 2022, titled "Reassessments/Update of the Comprehensive Assessment" stated, "... The comprehensive assessment (including OASIS data elements) ... must be updated and revised ... Recertification ... the last five days of every 60 days ...." 2. An agency job description received on 12/06/22, revised date February 2022, titled "Director of Clinical Services [Clinical Supervisor]", stated, "... Assures ongoing assessment of patient/family needs ...." 3. Clinical record review for Patient #2 was completed on 12/08/22 (start of care date 8/08/22). A document for certification period 10/07/22 - 12/05/22, titled "Home Health Certification and Plan of Care" evidenced the last 5 days of the patient's certification period was 12/01/22 - 12/05/22. A home visit was observed with Patient #2 and the Clinical Manager on 12/05/22 from 2:15 PM - 3:00 PM. The Clinical Manager failed to complete a comprehensive reassessment of the patient. During an interview on 12/08/22 at 12:03 PM, the Clinical Supervisor indicated the home visit for patient #2 on 12/05/22 was a comprehensive reassessment for recertification of home care services. When queried if she performed a complete comprehensive reassessment including assessment of the OASIS on the patient during the home visit on 12/05/22, the Clinical Manager indicated she didn't, and indicated the electronic medical record (EMR) software auto-filled most of that (on the comprehensive reassessment document) anyways. 4. Clinical record review for Patient #6 was completed on 12/08/22 (start of care date 10/07/22). A document for certification period 10/07/22 - 12/05/22, titled "Home Health Certification and Plan of Care" evidenced the last 5 days of the patient's certification period was 12/01/22 - 12/05/22. A home visit was observed with Patient #6 and the Clinical Manager on 12/05/22, from 11:00 AM - 12:05 PM. The Clinical Manager failed to complete a comprehensive reassessment of the patient. During an interview on 12/08/22 at 1:10 PM, the Clinical Manager indicated the home visit for patient #6 on 12/05/22 was a comprehensive reassessment for recertification of home care services. When queried if she performed a complete comprehensive reassessment including assessment of the OASIS on the patient during the home visit on 12/05/22, the Clinical Manager indicated she didn't, and she couldn't do some of the assessments required during a comprehensive assessment/reassessment because she had a bad elbow, and she just asked the patients questions instead of actually assessing them. 5. During an interview on 12/09/22 at 2:00 PM, the Administrator indicated he expected the nurse to assess everything (the patient) during a comprehensive assessment visit.

Within 48 hours of the patient's return CFR(s): 484.55(d)(2) Within 48 hours of the patient's return to the home from a hospital admission of 24 hours or more for any reason other than diagnostic tests, or on physician or allowed practitioner - ordered resumption date; This ELEMENT is not met as evidenced by: Based on record review and interview, the Registered Nurse failed to ensure a comprehensive assessment was completed for 1 of 3 clinical records reviewed with patients who were hospitalized during the certification period (#1). Findings include: An agency policy, revised date February 2022, titled "Reassessments/Update of the Comprehensive Assessment" stated, "... The comprehensive assessment (including OASIS data elements) ... must be updated and revised ... Resumption of care: [within] 48 hours of the patient's return home from a hospital admission ...." An agency job description received on 12/06/22, revised date February 2022, titled "Director of Clinical Services [Clinical Supervisor]", stated, "... Assures ongoing assessment of patient/family needs ...." Clinical record review for Patient #1 was completed on 12/06/22 (Start of care date 10/12/22). An undated, unsigned document titled "Transferred to an inpatient facility ....", evidenced the patient was transferred on 10/14/22, and the electronic medical record (EMR) indicated the document was "In Progress". A document dated 10/18/22, titled “Home Discharge Instructions”, evidenced the patient was hospitalized for emergent care at Entity #10 (a hospital) from 10/15/22 – 10/18/22, for seizures. A document dated 10/19/22, titled "Resumption of care (after inpatient stay)" (a comprehensive reassessment with OASIS items) stated, "... Status ... In Progress ...." The document failed to evidence a comprehensive reassessment was completed. During an interview on 12/08/22 at 2:30 PM, the Clinical Manager indicated documents marked in the EMR as “drafts” and/or “In Progress” were incomplete documents.

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 Registered Nurse (RN) failed to complete a comprehensive assessment upon discharge, for 3 of 3 clinical records reviewed for patients who were discharged from the agency (#1, 5, 7). Findings include: 1. An agency policy, revised date February 2022, titled "Reassessments/Update of the Comprehensive Assessment" stated, "... The comprehensive assessment (including OASIS data elements) ... must be updated and revised ... [when] discharged from agency ... within 2 calendar days of the discharge ... date ...." 2. An agency job description received on 12/06/22, revised date February 2022, titled "Director of Clinical Services [Clinical Manager]", stated, "... Assures ongoing assessment of patient/family needs ...." 3. Clinical record review for Patient #1 was completed on 12/06/22 (Start of care date 10/12/22, discharge date 11/28/22). The electronic medical record evidenced a comprehensive reassessment with OASIS items stated, "... Status ... In Progress ...." The document failed to evidence a comprehensive reassessment was completed. During an interview on12/06/22 at 2:00 PM, when queried to describe the discharge process, the Clinical Manager indicated they don't always do discharges "in person", it depended on their schedules, and sometimes they did it over the phone. When queried if a discharge comprehensive assessment was completed for patient #1, the Clinical Manager indicated it was "in progress". During an interview on 12/08/22 at 2:30 PM, the Clinical Manager indicated documents marked in the EMR as “drafts” and/or “In Progress” were incomplete documents. 4. Clinical record review for Patient #5 was completed on 12/09/22 (start of care date 9/06/22, discharge date 11/04/22). The EMR failed to evidence a discharge comprehensive assessment was completed. During an interview on 12/09/22 at 2:26 PM, the alternate Clinical Manager indicated the discharge comprehensive assessment wasn't completed, and it was almost entirely blank. 5. Clinical record review for patient #7 was completed on 12/09/22 (start of care date 11/09/22, discharge date 11/28/22). The EMR failed to evidence a comprehensive assessment was completed. During an interview on 12/09/22 at 2:30 PM, the alternate Clinical Manager indicated there wasn't a completed discharge comprehensive assessment in the patient's EMR.

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, record review, and interview, the Administrator failed to ensure: all patients' needs were met; all medical care/treatment provided by agency staff followed the written plan of care (Please see tag G0572); failed to ensure all patients' plans of care included all required elements (Please see tag G0574); failed to ensure the patient's plan of care was reviewed by the certifying physician when a significant change in condition occurred, and/or at least every 60 days (Please see tag G0588) This practice had the potential to affect all patients serviced by the agency. The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care for the Condition of Participation 42 CFR §484.60: Care Planning, Coordination of Services, and Quality of Care A standard level deficiency was also cited at this level. Based on observation, record review, and interview, the home health agency failed to ensure it only accepted patients for services if the needs of the patient could be met for 2 of 2 records reviewed with home visits by a Registered Nurse (RN) (#2, 6), and 1 of 1 patient accepted for care, with a pending initial evaluation date (#9); and failed to ensure each patient had a written plan of care, for 5 of 8 clinical records reviewed. (#1, 3, 5, 6, 7) The findings include: 1. An agency policy with revised date February 2022, titled "Plan of Care ... and Physician/Practitioner Orders", stated, "... home health services will be in accordance with a Plan of Care ...." 2. An agency policy with revised date February 2021, titled "Patient Admission Criteria" stated, "... Patients will be accepted for care only if Agency can meet a patient's identified needs ... personnel to provide needed services are available ...." 3. During an interview on 12/08/22 at 12:12 PM, the Clinical Manager stated "... No one works on Saturdays ... We don’t have staff for Saturdays ...." 4. During an interview on 12/08/22 at 3:30 PM, the Clinical Manager indicated she was leaving on a flight this evening (12/08/22), and would be back at work on Monday (12/12/22). When queried who would cover Registered Nurse (RN) Clinical Manager duties, the Clinical Manager indicated no one did, this was how the agency operated; if she wasn't available, no one covered, and patients had to wait until she returned. 5. On 12/09/22 at 12:55 PM, observed a phone call in progress with Employee #7 (Referral/Intake Supervisor), who indicated to the person on the phone that there was no nurse available today (12/09/22) for an admission visit (Patient #9). During an interview on 12/09/22 at 12:58 PM, Employee #7 indicated family of patient #9 called to see when the nurse was coming out to admit the patient for home care, and she gave family the Clinical Manager's number to schedule a time for Monday (12/12/22). During this time, all referral documents for Patient #9 was requested and received, which included: A document from entity #1 (a hospital), dated 12/01/22, titled "Home Care: Start of Care Orders ...." which indicated skilled nursing, physical therapy (PT) and home health aide (HHA) services were ordered on 12/01/22. A document from entity #1, dated 12/01/22, titled "Home Discharge Instructions", which indicated the patient was discharged from entity #1 on 12/01/22, and stated, "... Follow up Instructions ... with ... Paragon Home Care ... Within 1 to 2 days ... Nursing visit for staples removal on Friday 12/09/22 ...." During an interview on 12/09/22 at 1:01 PM, when queried about Patient #9's referral and status of admission, The Administrator indicated he didn't know about the referral. During an interview on 12/09/22 at 3:49 PM, when queried why Patient #9 wasn't admitted today (or sooner), Employee #7 indicated Patient #9 was never scheduled to begin today, and Person #2 already scheduled with the Clinical Manager for an initial evaluation on Monday (12/12/22). During an interview on 12/09/22 at 4:01 PM, Person #2 (family) indicated Patient #9 got out of the hospital about 2 weeks ago, she called Paragon Home Health Care about 2 days after Patient #9 was discharged from the hospital to get services started, and they (Paragon staff) told her they were waiting on a nurse and paperwork. Person #2 indicated she didn't hear back from Paragon, so she called again about a week later with no results, and called again today (12/09/22). When queried if she requested a delay in the start of home care services, Person #2 indicated she did not, and indicated when she called the Clinical Manager today to schedule the admission nursing visit, the Clinical Manager told her the delay was because they (Paragon Home Health Care) were waiting until after the patient got her staples out today to begin home health services, and she would be there Monday 12/12/22 at 1:00 PM. The home health agency accepted the patient for services, but failed to ensure personnel was immediately available to meet the patient's needs. 6. Clinical record review for Patient #1 was completed on 12/06/22 (Start of care date 10/12/22). A document received 11/30/22, titled "Home Health Certification and Plan of Care" for certification period 10/12/22 - 12/10/22, evidenced the document was a "draft", and failed to evidence it was completed. The electronic medical record (EMR) evidenced the document was "in progress". During an interview on 12/06/22 at 2:46 PM, the Clinical Manager indicated the plan of care was not completed. 7. Clinical record review for Patient #2 was completed on 12/08/22 (start of care date 8/08/22). A document dated 7/27/22, titled "[Entity #9, a wound clinic]", evidenced a referral from Entity #9 was received by the home care agency. A document dated 7/26/22, signed by Person #19 (Patient #2's certifying physician), titled "Physician Order Details", stated, "... Admit to Home Health for wound care ... Dressing changes to be completed by home health on Tuesday ... Thursday ... Saturday ...." A document for certification period 8/08/22 - 10/06/22, titled "Home Health Certification and Plan of Care" evidenced home care services were initiated 12 days after the referral was received, skilled nursing was ordered twice the first week, then weekly for 8 weeks. The home health agency accepted the patient for services, services were delayed, and failed to ensure personnel provided wound care on Tuesdays, Thursdays, and Saturdays as ordered by the patient's certifying physician. A document dated 10/18/22, titled "Physician Order Details", evidenced orders for home health to continue wound care every other day. A document for certification period 10/07/22 - 12/05/22, titled "Home Health Certification and Plan of Care" evidenced skilled nursing was ordered 3 times weekly for 8 weeks, then once per week for 1 week. The agency failed to ensure personnel provided wound care as ordered (every other day) to meet the patient's needs. During an interview on 12/06/22 at 3:11 PM, the Clinical Manager indicated she received the patient's information on 8/02/22 (Tuesday), the patient went to wound clinic on 8/04/22 (Thursday), and she did the initial evaluation/comprehensive assessment on 8/08/22 (Monday), and stated "... because I don’t work on Saturdays ...." When queried what agency staff worked on Saturdays, the Clinical Manager stated, "... No one ...." The Clinical Manager indicated the patient referral was originally given to another nurse, the other nurse said it was too far (travel), so it came to her (Clinical Manager). When queried why the patient wasn't getting nursing visits every other day as ordered, the Clinical Manager stated, "... We don’t work on Saturdays, and the [family] agreed it was okay ...." During an interview on 12/09/22 at 2:00 PM, when queried of her expectations when the wound clinic ordered wound treatment on Tuesdays, Thursdays and Saturdays, the alternate Clinical Manager stated, "... They better go on those days because that’s a written order ....", and indicated if the order wasn't followed, it shouldn't be because the nurse didn’t want to work on Saturdays. 8. Clinical record review for Patient #3 was completed on 12/08/22 (start of care date 1/31/22). A document titled "Home Health Certification and Plan of Care" for certification period 9/28/22 - 11/26/22, evidenced the document was a "draft", and failed to evidence it was completed. On 12/02/22, at 11:41 AM, the EMR evidenced 3 additional documents, titled "Home Health Certification and Plan of Care", for certification periods 5/31/22 - 7/29/22, 7/30/22 - 9/27/22, and 9/28/22 - 11/26/22, which evidenced they were all "in progress", and failed to evidence any were completed. During an interview on 12/08/22 at 2:30 PM, the Clinical Manager indicated all plans of care were autogenerated by the EMR, and all documents marked as "drafts" or "in progress" were not yet completed. 9. Clinical record review for Patient #5 was completed on 12/09/22 (start of care date 9/06/22). Review of the EMR on 12/02/22 at 4:30 PM evidenced a document for certification period 9/06/22 - 11/04/22, dated 9/26/22, titled "Home Health Certification and Addendum to Plan of Care" (a revised plan of care), was "in progress", and failed to evidence it was completed. 10. Clinical record review for Patient #6 was completed on 12/08/22 (start of care date 10/07/22). A document dated 9/15/22, titled "Progress Note Details", evidenced Entity #12 (a wound clinic) ordered wound care to be performed every 2 days. A document dated 9/30/22, titled "Physician Orders Details", evidenced Entity #12 ordered wound care to be performed every 2 days. A document dated 10/28/22, titled "Physician Orders Details" evidenced Entity #12 ordered wound care to be performed every 2 days. A document dated 12/06/22, titled "Physician Orders Details" evidenced Entity #12 ordered wound care to be performed every 2 days. A document for certification period 10/07/22 - 12/05/22, titled "Home Health Certification and Plan of Care" skilled nursing was ordered was once weekly for 1 week, 3 times weekly for 8 weeks (weeks 2-9), then once weekly for 1 week, and the document was a "draft". The home health agency accepted the patient for services, but failed to ensure personnel provided wound care every 2 days as ordered by Entity #12, and failed to ensure the plan of care was completed. During an interview on 12/08/22 at 1:10 PM, when queried why agency staff failed to provide nursing visits every 2 days, the Clinical Manager stated, "... we don’t work weekends ... it’s like every other day [3 times per week] ... well ... except the weekends ...." 11. Clinical record review for Patient #7 was completed on 12/09/22. A document for start of care 11/09/22, certification period 11/09/22 - 1/07/22, titled "Home Health Certification and Plan of Care" evidenced the document was a "draft", and failed to evidence the document was completed. During an interview on 12/09/22 at 2:30 PM, Employee #6 indicated the plan of care was not completed. 12. During an interview on 12/05/22 at 3:00 PM, the Clinical Manager indicated she was very behind with the completion of her documentation.

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 home health agency failed to ensure all medical care/treatment provided by agency staff followed the written plan of care; and/or failed to ensure the plan of care was reviewed and signed by the certifying physician, for 8 of 8 clinical records reviewed (#1, 2, 3, 4, 5, 6, 7, 8). Findings include: 1. An agency policy with revised date February 2022, titled "Plan of Care ... and Physician/Practitioner Orders", stated, "... Skilled nursing and other home health services will be in accordance with a Plan of Care ... Each Plan of Care must be signed and dated by the physician ... If a physician/practitioner refers a patient under a plan of care that cannot be completed until after an initial evaluation visit, the physician is consulted to approve additions or modifications to the original plan ... Orders for therapy services include the specific procedures ... and the amount, frequency and duration ... All patient care orders, including verbal orders, must be recorded in the plan of care ... The plan of care may include orders for treatment or services received from physicians other than the [certifying] physician ... Such orders must be approved by the [certifying] physician and incorporated into an updated plan of care ...." 2. An agency policy with revised date February 2017, titled "Professional Standards of Practice", stated, "... Agency staff will provide care, treatment and services to each patient according to the plan of care ...." 3. Clinical record review for Patient #1 was completed on 12/06/22 (Start of care date 10/12/22). A document received 11/30/22, titled "Home Health Certification and Plan of Care" for certification period 10/12/22 - 12/10/22, indicated the document was a "draft", Skilled Nursing was ordered weekly for 9 weeks; Physical Therapy (PT), Occupational Therapy (OT) was ordered to evaluate and treat; and Home Health Aide (HHA) services were ordered twice weekly for 8 weeks. The initial plan of care failed to evidence it was reviewed, approved, or signed by the certifying physician. The electronic medical record (EMR) failed to evidence the PT evaluation dated 10/13/22, and OT evaluation dated 10/26/22, were sent to the certifying physician to update the initial plan of care, and failed to evidence an HHA plan of care. The EMR failed to evidence any nursing visits were documented as completed after the start of care visit on 10/12/22. No HHA visits were documented as completed for the week of 10/12/22 (week 1), only 1 HHA visit was made the week of 10/16/22 (week 2), no HHA visits were documented as completed week of 10/30/22 (week 4), week of 11/06/22 (week 5), or week of 11/13/22 (week 6), week of 11/20/22 (week 7). The agency's skilled nursing and HHA staff failed to follow visit frequencies as ordered on the plan of care. During an interview on 12/06/22 at 1:47 PM, the Administrator indicated there were no signed orders from any physician for Patient #1. During an interview on 12/06/22 at 2:00 PM, the Clinical Manager indicated she previously saw a Home Health Aide (HHA) plan of care in the electronic medical record (EMR) for Patient #1, but could not find it now. When queried if therapy evaluations and therapy plans of care were sent to the certifying physician for approval/signature, the Clinical Manager stated "Yes ....", but indicated she couldn't see in the EMR where Patient #1's Physical Therapy (PT) or Occupational Therapy (OT) evaluations/plans of care were sent to the certifying physician for approval/signature. Employee #6 (Office Staff) indicated she did not send therapy evaluations/plans of care to the physicians for signature. The Administrator then queried if they were required to send therapy evaluations/plans of care to the certifying physician for approval/signature. When queried what was considered to be the updated plan of care, the Clinical Manager stated "... We get orders and they stay separate from the plan of care ...." When queried if she would expect the Therapists to contact the certifying physician for review and approval of therapy plans of care/orders, the Clinical Supervisor stated "Yes ....", and the Administrator stated "... we would just send the eval [evaluation] [to the certifying physician] ... the eval should go to the physician ....". When queried how the patient's plan of care was created, the Clinical Manager stated "It autogenerates ... We have to add some stuff ... It picks up what it wants ...." 4. A home visit was observed with Patient #2 and the Clinical Manager on 12/05/22 from 2:15 PM - 3:00 PM. The Clinical Manager provided wound care to the patient's left lateral (outside of foot) ankle. The wound was cleansed with normal saline (sterile salt water), a collagen pad (stimulates new tissue growth) was applied to the wound bed, a foam adhesive dressing was applied, and an elastic stocking was applied to the lower leg/foot. Observed an Entity #9 document (a wound clinic the patient attended for treatment and orders), dated 11/29/22, which indicated the wound care was ordered to be performed every other day by the agency nurse. During this visit, the Clinical Manager failed to provide any teaching to the patient or family. During an interview on 12/06/22 at 3:11 PM, when queried why she didn't follow Entity #9's orders to change the dressing every other day, the Clinical Manager indicated agency staff didn't work on Saturdays, and family agreed it was okay to just change the dressing 3 times weekly. Clinical record review for Patient #2 was completed on 12/08/22 (start of care date 8/08/22). A document titled "Home Health Certification and Plan of Care" for certification period 10/07/22 - 12/05/22, indicated Skilled Nursing was ordered 3 times weekly for 8 weeks, then once for 1 week, orders included skilled nurse to teach diet, disease process, home safety/fall prevention, signs/symptoms of infection, and to provide wound care, but failed to evidence specific wound care orders. The EMR failed to evidence any nursing visits were made the week of 10/07/22, only 2 visits were made during the weeks of 10/09/22 and 10/16/22, and failed to evidence the nurse attempted a third visit either week; failed to evidence any nursing visits were made during the week of 11/27/22 (week 9); and there were no orders for the visit that occurred on 12/05/22 (week of 12/04/22, week 10). The agency's skilled nursing staff failed to follow visit frequencies as ordered on the plan of care. During an interview on 12/08/22 at 12:03 PM, the Clinical Manager indicated she didn’t teach anything during the visit on 12/05/22, the patient was referred from Entity #9, they did not re-schedule missed visits, and they followed Entity #9 orders for wound care. 5. Clinical record review for Patient #3 was completed on 12/08/22 (start of care date 1/31/22). A document titled "Home Health Certification and Plan of Care" for certification period 9/28/22 - 11/26/22, indicated Skilled Nursing was ordered one time week of 9/28/22 (week 1), then twice weekly for 8 weeks, for wound care to the left groin. The record failed to evidence a nursing visit was performed the week of 9/28/22 (week 1). The agency's skilled nursing staff failed to follow visit frequencies as ordered on the plan of care. During an interview on 12/08/22 at 2:30 PM, the Clinical Manager indicated the visit during week #1 was a missed visit because the patient went to the wound clinic on 9/29/22 (Thursday) week 1, they don’t work weekends, so no other visit was attempted that week. 6. Clinical Record review for Patient #4 was completed on 12/09/22 (start of care date 1/26/22). A document for certification period 11/22/22 - 1/20/23, titled "Home Health Certification and Plan of Care" evidenced skilled nursing was ordered "one visit every other week for monthly lab work". The record evidenced a skilled nursing visit was made on 11/23/22, and as of 12//09/22 at 1:56 PM (sixteen days later), no other skilled nursing visits were made. The record failed to evidence the agency's skilled nursing staff followed visit frequencies as ordered on the plan of care, any lab results, when the last time labs were obtained, or when the next time labs were due. During an interview on 12/09/22 at 1:41 PM, the alternate Clinical Manager indicated she expected to see when the nurse last drew labs, the next time it was due, and there were no lab results in the EMR. 7. Clinical record review for Patient #5 was completed on 12/09/22 (start of care date 9/06/22). A document dated 9/26/22, titled "Start of Care ...." (the initial comprehensive assessment) evidenced the nurse provided wound care and treatments to the patient's abdomen and left buttock. A document for certification period 9/06/22 - 11/04/22, titled "Home Health Certification and Plan of Care" evidenced skilled nursing was ordered once weekly for 9 weeks, PT and OT was ordered to "evaluate and treat", the patient had wounds to the abdomen and left buttock, but failed to include wound care orders for either wound. During an interview on 12/09/22 at 2:26 PM, the alternate Clinical Manager indicated if visit frequencies weren't followed, the visits would need to be made up, or the plan of care should be updated with new frequency orders; she expected to see wound care orders for the nurse to follow on the plans of care; every time the orders changed, the plans of care should be updated; and she didn't see evidence PT or OT evaluations were sent to the certifying physician for review/approval or signature. 8. A home visit was observed with Patient #6 and the Clinical Manager on 12/05/22 from 11:00 AM - 12:05 PM. The patient indicated she went to the wound clinic (Entity #1) about every month, that's who managed her leg wounds, and indicated Person #11 was her primary care physician (PCP), whom she saw in October (2022) for a flu shot. The Clinical Manager performed extensive wound care to each lower extremity, measured lengths/widths of each wound, but failed to measure the depth of either wound, or provide any teaching during the visit. Clinical record review for Patient #6 was completed on 12/08/22 (start of care date 10/07/22). A document for certification period 10/07/22 - 12/05/22, titled "Home Health Certification and Plan of Care" evidenced skilled nursing was ordered once for the first week, 3 times weekly for 8 weeks, and 1 time for 1 week; the patient had wounds to both lower legs, an order to measure wounds weekly (length x width x depth), wound care was ordered, other orders included to teach disease process, diet, home safety/falls prevention, signs/symptoms of infection, and wound care/dressing. The plan of care stated "...Draft ....", and indicated Person #11 was the certifying physician; and failed to evidence any wound care treatment orders from Entity #1, or evidence Person #11 reviewed, approved, or signed the plan of care. The EMR evidenced only 2 visits were made the week of 10/16/22 (week 3), 10/23/22 (week 4), and 11/13/22 (week 7), and failed to evidence the nurse attempted to schedule a third visit during those weeks. The agency's skilled nursing staff failed to follow visit frequencies as ordered on the plan of care. A document from Entity #1, dated 9/30/22, titled "Physician Order Details", indicated wound care/treatment frequency for each lower leg was ordered to be done every other day. The EMR failed to evidence nursing visits were made every other day. During an interview on 12/08/22 at 1:10 PM, when queried, the Clinical Manager indicated they didn't do every other day visits because they don't work weekends, 3 times a week was almost like every other day except for the weekends, the patient was seen by the agency for wound care ordered by the wound clinic (Entity #1), Person #11 was not part of Entity #1, he was the PCP [primary care practitioner], and the plan of care wasn't signed by Person #11. When queried if the physician was notified of the deviation from ordered skilled nursing visit frequencies, the Clinical Manager indicated the EMR should auto populate an order. Upon survey exit, nothing further was submitted for review. 9. Clinical record review for patient #7 was completed on 12/09/22 (start of care date 11/09/22). A document dated 10/26/22 titled "Home Care- Start of Care Orders ....", indicated the patient had a new colostomy placed 10/25/22, port-a-cath (a surgically implanted device which allows easy access to a patient's veins) placement 10/25/22, and had colon cancer. A document dated 11/03/22, titled "Progress Notes", indicated Paragon Home Health Care accepted the patient for services, the patient had a port-a-cath to the left upper chest with steri-strips (porous surgical tape strips used to close small wounds) in place, needs included home health care for negative pressure wound treatment, colostomy and Jackson Pratt (JP) drain (a closed-suction medical device that is commonly used as a post-operative drain for collecting bodily fluids from surgical sites) care/teaching. A document titled "Home Health Certification and Plan of Care" (certification period 11/09/22 - 1/07/23) evidenced skilled nursing was ordered twice the first week, then 3 times weekly for 8 weeks. Orders included assessment, wound care, ostomy teaching, instruct ostomy care, and monitor JP drain site for signs of infection. The record evidenced only 1 skilled nursing visit was made during the week of 11/13/22 (week 2), no skilled nursing visits were made after 11/15/22 (week 3), and there was no order to discharge the patient from services (discharged week of 11/27/22 [week 4]). The agency's skilled nursing staff failed to follow visit frequencies as ordered on the plan of care. Documents dated 11/11/22, 11/14/22, 11/21/22, 11/23/22, 11/25/22, titled "Skilled Nurse Visit", failed to evidence the nurse assessed the port-a-cath, the JP drain, provided colostomy teaching, or provided/instructed on colostomy care. During an interview on 12/09/22 at 2:30 PM, Employee #6 indicated the plan of care and other orders weren't completed or signed by the physician. The alternate Clinical Manager indicated she would expect the nurse to do what was ordered on the plan of care, the plan of care was a "hot mess", and it was "missing everything". 10. Clinical record review for Patient #8 was completed on 12/09/22 (start of care date 8/11/22). A document titled "Home Health Certification and Plan of Care" (certification period 11/09/22 - 1/07/23) evidenced Home Health Aide (HHA) services were ordered twice weekly for 9 weeks. The record failed to evidence 2 HHA visits were made during the week of 10/30/22 (week 4), and failed to evidence the HHA attempted to re-schedule the visit for later the same week. The agency's HHA staff failed to follow visit frequencies as ordered on the plan of care. During an interview on 12/09/22 at 1:19 PM, the alternate Clinical Manager indicated staff should try to re-schedule missed visits, especially if the missed visit was early in the week.

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 observation, record review, and interview, the home health agency failed to ensure all patients' plans of care included one or more of the following: all services provided, all pertinent diagnoses, the patient's mental status, types of services and/or equipment required, frequency and duration of visits, nutritional requirements, medications and treatments, safety measures to protect against injury, therapy modalities specifying length of treatment, and any other appropriate items identified by the agency's own policy, for 8 of 8 clinical records reviewed (#1, 2, 3, 4, 5, 6, 7, 8). Findings include: 1. An agency policy with revised date February 2022, titled "Plan of Care ... and Physician/Practitioner Orders", stated, "Each patient must receive an individualized written plan of care, including any revisions or additions ... must specify the care and services necessary to meet the patient-specific needs ... specify the patient and caregiver training ... identifies patient-specific measurable outcomes and goals ... Patient specific goals must be individualized to the patient ... as well as patient preferences ... All pertinent diagnoses ... mental, psychosocial and cognitive status ... supplies and equipment required ... frequency and duration of visits ... Rehabilitation potential ... Functional limitations ... Activities permitted ... Nutritional requirements ... All medications and treatments ... Safety measures to protect against injury ... A description of the patient's risk for emergency department visits and hospital readmissions, and all necessary interventions to address the underlying risk factors ... Patient-specific interventions and education ... measurable outcomes and goals identified by ... the patient ... All patient care orders, including verbal orders, must be recorded in the plan of care ... The plan of care may include orders for treatment or services received from physicians other than the [certifying] physician ... Such orders must be approved by the [certifying]] physician ... and incorporated into an updated plan of care ...." 2. Clinical record review for Patient #1 was completed on 12/06/22 (Start of care date 10/12/22, discharge date 11/28/22). A document dated and signed by Person #7 (a physician), titled "Progress Note", evidenced diagnoses included seizures and anemia, a history of hypertension (high blood pressure), and swelling of both lower extremities; medications included Aricept (to treat Alzheimer's Disease) 10 milligrams (mg) daily, Voltaren gel (a topical pain reliever), triamcinolone cream (a steroid cream to help relieve redness, itching, swelling, or other discomfort caused by skin conditions), turmeric (herbal remedy to reduce swelling), and was not taking folic acid; equipment included a motorized scooter and a semi-electric hospital bed. A document dated 10/12/22, titled "Start of Care" (initial comprehensive assessment) evidenced the patient was a high fall risk, experienced a stroke with dysphagia (difficulty swallowing) and right side affected, had pain that affected ability to transfer/walk, a skin area was identified under the right abdominal fold which required intervention (family applied petroleum jelly and placed a wash cloth under the fold), incontinent of urine, was a moderate nutritional risk, unable to stand, transfer, or walk, and had significant memory loss so that supervision was required. A document received 11/30/22, titled "Home Health Certification and Plan of Care" (start of care date 10/12/22, certification period 10/12/22 - 12/10/22), failed to evidence the patient's diagnoses of seizures, anemia, hypertension, swelling of both lower extremities, or stroke with dysphagia and right side affected; failed to evidence medications included the patient took 10 mg of Aricept daily (plan of care indicated 5 mg daily), the patient used Voltaren gel (a topical pain reliever), triamcinolone cream, turmeric, and evidenced the patient took folic acid (physician progress note indicated the patient was not taking folic acid); equipment included a motorized scooter and a semi-electric hospital bed; interventions/goals for the skin area identified under the right abdominal fold, incontinence of urine, moderate nutritional risk, unable to stand, transfer, or walk; safety measures included requirement for supervision due to significant memory loss; or mental status included significant memory loss. The plan of care stated, "... Risk of Hospitalization ... Multiple hospitalizations ... in the past 6 months ... Currently taking 5 or more medications ... Patient and caregiver communicate care preferences ... Yes ... Patient and caregiver communicate any specific information about a personal goal(s) the patient would like to achieve from this home health admission ... Yes ....", and goals included "demonstrated compliance with medication" and "verbalized pain control". The plan of care also failed to evidence interventions to mitigate risks for hospitalization, the patient's care preferences or personal goal(s), measurable goals, or interventions to mitigate medication compliance or pain relief/control goals. During an interview on 12/06/22 at 2:00 PM, when queried how the patient's plan of care was created, the Clinical Manager stated, "It autogenerates ... We have to add some stuff ... It picks up what it wants ...." During an interview on 12/06/22 at 2:46 PM, the Clinical Manager indicated she expected to see all wound care/treatment orders on the plans of care, treatment provided to Patient #1's abdominal fold, but the EMR didn't pull it over from the comprehensive assessment. When queried about durable medical equipment (DME) and supplies on the plans of care, the Clinical Manager stated "... We don’t fill in the DME and supplies [on the plans of care] unless we are actually providing it ... 99% of the time they have their own [supplies to use] ...." The Clinical Manager also indicated all diagnoses should be on the plans of care, but "Joint Commission" (a company contracted by Medicare to ensure federal regulations are met) told us if it’s a resolved diagnosis, it doesn’t have to be on there (the plan of care); the agency did not obtain copies of advance directives for the clinical record, and there were no patient goals on the plans of care. The Clinical Manager additionally stated, "... The EMR is not good ...." 3. A home visit was observed with Patient #2 and the Clinical Manager on 12/05/22 from 2:15 PM - 3:00 PM. The Clinical Manager provided wound care to the patient's left lateral (outside of foot) ankle. Supplies used included normal saline (sterile salt water), collagen pad (used to encourage tissue regeneration), foam adhesive cover dressing, and a compression stocking. Clinical record review for Patient #2 was completed on 12/08/22 (start of care date 8/08/22). A document dated 10/06/22, titled "Recertification (follow up) Assessment" (a comprehensive reassessment) evidenced the patient required daily diabetic foot examinations, edema (swelling) to both lower legs, blood sugar levels were checked daily before breakfast (fasting), blood sugar levels ranged between 70-200 (fasting blood sugar level of 99 or lower is normal), moderate nutritional risk, risk for falls, and the patient had severe shortness of breath/shortness of breath upon exertion. A document titled "Home Health Certification and Plan of Care" for certification period 10/07/22 - 12/05/22, evidenced the patient took levothyroxine (to treat hypothyroidism), duloxetine (to treat depression and anxiety, and is also used for pain caused by nerve damage/pain associated with diabetic peripheral neuropathy), repaglinide (to treat high blood sugar levels in patients with type 2 [adult onset] diabetes), and Eliquis (used to reduce the risk of stroke and blood clot formation in patients with atrial fibrillation [irregular heart rhythm]); and skilled nursing interventions included to teach disease process, diet, home safety/falls prevention, medications, wound care/dressing change. The plan of care failed to evidence diagnoses of hypothyroidism, depression and/or anxiety, diabetic peripheral neuropathy, diabetes with hyperglycemia (high blood sugar levels), or atrial fibrillation. The plan of care failed to evidence supplies included normal saline, collagen pad, foam adhesive cover dressing, or a compression stocking; or the patient's wound care/treatment orders. The plan of care failed to evidence orders for daily diabetic foot examinations (or who performed the examination), interventions to mitigate edema (swelling) to both lower legs, orders to check daily fasting blood sugar levels (or who performed the check), interventions to mitigate high blood sugar levels, interventions for moderate nutritional risk and risk for falls; interventions to mitigate severe shortness of breath/shortness of breath upon exertion; or any patient stated goals. During an interview on 12/06/22 at 3:11 PM, when queried if the patient's wound care treatment orders were on the plan of care, the Clinical Manager indicated the plan of care would show to measure it (wound[s]) weekly, the name and location of the wound, and she would expect to see treatment orders on the on the plan of care. 4. Clinical Record review for Patient #3 was completed on 12/08/22. A document received from Entity #10 (hospital based wound clinic) on 12/02/22, dated 9/29/22, titled “Progress Note Details”, stated, “... patient was seen today for follow up and management of L [left] groin and L buttock wound ... Patient has a medical history of ... Hypertension [high blood pressure] ... Coronary Artery Disease ... Depression ... Colostomy [an opening into the colon from the outside of the body, to provide a new path for waste material to leave the body after part of the colon has been removed] ... [patient] ... instructed to check her blood sugars once a day but no diagnosis of [diabetes] ... Wound Assessment(s) ... Left Groin is a full thickness Surgical Wound ... Not Healed ... Left Buttock is ... Stage 2 Pressure Injury [wound with partial-thickness skin loss into but no deeper than the layers of the skin, including intact or ruptured blisters] ... The patient is obese ... Diagnosis ... Other obesity due to excess calories ... Wound Orders ... Left Groin ... Clean wound with Normal Saline – With wound vac [medical device to provide negative pressure wound therapy] ... Change dressing two times weekly ... NPWT [negative pressure wound therapy] Pressure 125 mmHG [millimeters of mercury- a unit of pressure equal to the pressure that can support a column of mercury 1 millimeter high] – Cavilon [medication is used as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations], benzoin [gum resin used especially in treating skin irritation], duoderm [breathable dressings for the management of light to moderately draining wounds] to periwound [skin areas around outside border of wound]; ... Crushed Flagyl [an antibiotic medication], Promogran [a dressing to maintain a physiologically moist microenvironment at the wound surface, which is conducive to wound healing] to the wound base, white foam to the wound base, black foam into empty space ... Wound ... Left Buttock ... Clean wound with ... soap and water ... Continue using foam and drape as needed for open areas ... Change 3x [3 times] weekly or as needed ... Use wheelchair cushion ... shift position in chair every 15 minutes ... Mattress Overlay/Specialty bed or mattress ... turn every 2 hours ... Dietary ... Increased protein ... 50-60 grams daily for wound healing ... Supplement with a daily multivitamin ... Ensure [nutritional supplement drink] ... Juven powder [powdered nutritional supplement for wound healing] ... orders to Paragon Homecare ... The goal ... is to keep the wound clean and free of ... infections ....” A document titled “Home Health Certification and Plan of Care”, for certification period 9/28/22 – 11/26/22 evidenced primary diagnosis of multiple sclerosis (a disease that impacts the brain, spinal cord and optic nerves, which make up the central nervous system and controls everything we do); other diagnoses included ulceration of vulva (the outer part of the female genitalia), prediabetes (a serious health condition where blood sugar levels are higher than normal, but not high enough yet to be diagnosed as type 2 diabetes), and ST elevation (STEMI) myocardial infarction (A heart attack with a completely blocked coronary artery). The plan of care failed to evidence other pertinent diagnoses of Hypertension, Coronary Artery Disease, Depression, Left Buttock Stage 2 Pressure Injury, or Other obesity due to excess calories. Medications on the plan of care included Norco (an opioid narcotic medication to treat pain), alpha lipoic acid (a medication used to manage and treat chronic diseases associated with oxidative stress, such as diabetic neuropathy, and slow down the onset of metabolic syndrome [a condition that includes high blood pressure, high blood sugar, excess body fat around the waist, and abnormal cholesterol levels] by acting as an antioxidant), hydrochlorothiazide and lopressor (both to treat high blood pressure), and sertraline (to treat depression). The plan of care failed to evidence medications also included a daily multivitamin, or crushed flagyl, used in wound treatment. Nutritional requirements on the plan of care evidenced a “regular diet” (does not include any dietary restrictions). The plan of care failed to include nutritional/dietary requirements included increased protein intake of 50-60 grams daily for wound healing, use of Ensure nutritional supplement drink, and Juven powdered supplement for wound healing. Interventions on the plan of care included to teach disease process, diet, home safety/fall prevention, signs and symptoms of infection, medications; wound care site was the left groin, measure wound(s) weekly, teach wound care/dressing, and suprapubic catheter (a tube inserted in the lower abdomen, directly into the bladder to drain urine) insertion every month. The plan of care failed to evidence skilled interventions to mitigate pain, use of narcotic medications, management of hypertension, coronary artery disease, or depression; methods to reduce obesity, daily blood sugar level monitoring, wound treatment orders for the left groin or left buttock; interventions for assessment/management of suprapubic catheter insertion site or colostomy site; or interventions for prevention of new/worsening skin breakdown. Goals on the plan of care stated “... Stabilization of cardiovascular pulmonary condition by 2 weeks (date) [no date entered] ... Demonstrates competence in following medical regime by 2 weeks (date) [no date entered] ... Demonstrates independence in skin care by end of cert [certification] period (date) [no date entered] ... Wound healing without complications by end of cert [certification] period (date) [no date entered] ....” The plan of care failed to evidence patient stated goals, Entity #10’s wound care goal, or patient-specific measurable outcomes/goals for Multiple Sclerosis, coronary artery disease, hypertension, pain, prediabetes, target fasting blood sugar levels, target weight, infection prevention/control, prevention of new/worsening skin breakdown, or suprapubic catheter and colostomy statuses. During an interview on 12/08/22 at 2:30 PM, the Clinical Manager confirmed the patient went to the wound clinic on 9/29/22, the plan of care (for certification period 9/28/22 – 11/26/22) was still a "draft", and was not yet completed. 5. Clinical Record review for Patient #4 was completed on 12/09/22. A document dated 11/21/22, titled "Recertification (follow up) Assessment", evidenced the patient was a high fall risk, lived in her own house and had no available caregiver; risks for hospital admission included 2 or more falls- or any fall with injury- in the past 12 months, and currently taking 5 or more medications; patient had a stasis ulcer (a wound caused by impaired circulation) of the left medial (inside) lower leg, wound care was provided which included: cleansed with normal saline and patted dry; hydrofera blue pad (provides wound protection and addresses bacteria and yeast) applied to the wound bed, covered with gauze pads, secured with gauze roll and tubigrip (elastic, tubular compression bandage, cut to length); the actual wound care order were to apply a cotton layer wrap over the wound dressing, compression wrap, and coban (a self-adherent elastic wrap), but the patient refused because it was too tight; and had difficulty breathing during routine activities of daily living. A document dated 11/17/22, titled "Progress Note Details" evidenced the patient was seen at Entity #12 (a bone and joint clinic) by Person #13 (a podiatrist who specialized in injury, wound, and diseases of the foot and lower leg); the patient had an unhealed wound on the left, medial lower leg, and an unhealed wound to the left, lateral (outside) lower leg; wound orders included: cleanse with normal saline, apply hydrofera blue to wound bed, cover with gauze and softroll (thick cotton padded roll), wrap with surepress and secure with coban; and nurse to change next week. A document for certification period 11/22/22 - 1/20/23, titled "Home Health Certification and Plan of Care" evidenced the document was a "draft", the patient's primary diagnosis was Hypertensive heart disease with heart failure (heart's problems developed over a long period of time, caused by high blood pressure); other pertinent diagnoses included chronic (long standing) atrial fibrillation, and pleural effusion (fluid accumulation around the lungs due to poor pumping by the heart or by inflammation); skilled nursing was ordered "one visit every other week for monthly lab work"; and risk of hospitalization included the patient currently took 5 or more medications. The plan of care failed to evidence wound diagnoses. Interventions on the plan of care included to evaluate cardiopulmonary status (heart and lung function), nutrition, hydration and elimination; teach disease process, diet, home safety/fall prevention; and monthly INR (a blood test to determine therapeutic drug levels for warfarin/coumadin [blood thinner]). The plan of care failed to evidence skilled interventions to mitigate exacerbation of hypertensive heart disease with heart failure, chronic atrial fibrillation, or pleural effusion; interventions to reduce risk of hospitalization, any wound care/treatment orders, or interventions to prevent new or worsening wounds. Goals on the plan of care stated “... Demonstrates compliance with medication by 2 weeks (date) [no date entered] ... Demonstrates competence in following medical regime by 2 weeks (date) [no date entered] ... Demonstrates independence in skin care by end of cert [certification] period (date) [no date entered] ... Wound healing without complications by end of cert [certification] period (date) [no date entered] .... Aide [Home Health Aide [HHA]) ... Assumes responsibility for personal care needs by end of cert [certification] period (date) [no date entered] ....” The plan of care failed to evidence orders/interventions for a HHA to provide care/services; and failed to evidence patient stated goals, patient-specific measurable outcomes/goals for hypertensive heart disease with heart failure, chronic atrial fibrillation, pleural effusion, or new/worsening wounds. During an interview on 12/09/22 at 1:41 PM, the alternate Clinical Manager stated, "... This plan of care is missing pretty much everything ...." 6. Clinical record review for Patient #5 was completed on 12/09/22 (start of care date 9/06/22). A document dated 9/26/22, titled "Start of Care ...." (the initial comprehensive assessment) evidenced the patient was a high fall risk, lived alone around the clock, lived in a senior living community with no available caregiver, had dysphagia (trouble swallowing), patient checked own fasting blood sugar daily, levels were between 70-150 (99 and below is normal), had a stage 2 pressure injury to the left buttock, and a surgical wound to the abdomen; wound care provided during the visit included: both wounds cleansed with normal saline and patted dry, abdominal wound was packed with wet gauze pads, covered buttock wound with collagen and secured it with a bordered foam bandage, covered the abdominal wound with an abdominal pad and secured it with soft cloth surgical tape; was incontinent of urine, high nutritional risk, and the reason for home care admission was wound care and therapy services. A document dated 7/16/22, with Entity #14 (a hospital) letterhead, titled "Internal Med History and Physical ....", evidenced the patient had a small bowel obstruction, and was admitted to Entity #14 for surgery. A document for certification period 9/06/22 - 11/04/22, titled "Home Health Certification and Plan of Care" evidenced Skilled Nursing, Physical Therapy (PT), and Occupational Therapy (OT) services were ordered, diet was regular with no concentrated sugar, and the patient had wounds to the abdomen and left buttock. Primary diagnosis was pressure ulcer of left buttock, stage 2; other pertinent diagnoses included intestinal obstruction, encounter for surgical aftercare following surgery on the digestive system, and diabetes. Medications on the plan of care included norco for pain, docusate sodium (stool softener), and senna laxative. Interventions on the plan of care included skilled observation for wound care, evaluate nutrition, hydration and elimination, signs and symptoms of infection; teach disease process, diet, home safety/fall prevention, and signs/symptoms of infection; and evaluate wound(s) for healing, measure wound(s) weekly, teach wound care/dressing. The plan of care failed to evidence skilled interventions to mitigate pain, prevent constipation or other bowel complications after surgery, interventions to reduce risk of hospitalization, any wound care/treatment orders, or interventions to prevent new or worsening wounds. During an interview on 12/09/22 at 2:26 PM, the alternate Clinical Manager indicated she expected to see wound care orders for the nurse to follow on the plans of care, as well as all treatments and interventions/teaching specific to the patient, and every time the orders changed, the plans of care should be updated. 7. A home visit was observed with Patient #6 and the Clinical Manager on 12/05/22 from 11:00 AM - 12:05 PM. The patient indicated she was allergic to Penicillin, but didn't see the allergy listed on her home plan of care. The Clinical Manager indicated the EMR didn't always pull things into the plan of care correctly. The patient indicated she went to the wound clinic (Entity #1) about every month, that's who managed her leg wounds, and indicated Person #11 was her primary care physician (PCP), whom she saw in October (2022) for a flu shot. The Clinical Manager performed wound care to each lower extremity, and applied over the counter moisturizer cream to intact skin on both lower legs. The patient complained of pain during the wound care, and indicated she took tramadol (an opioid pain medication for moderate to severe pain). The patient indicated she no longer used triamcinolone cream (used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions) on her lower legs. Wound supplies included normal saline (sterile salt water), gauze pads, hydrofera blue pads (a bacteriostatic dressing), optilock pads (highly absorbent pads) elastic compression wraps, elastic gauze wraps, incontinence pads, and abdominal pads (thick cotton pads to absorb drainage). Equipment included a cane, walker, and wheelchair. Clinical record review for Patient #6 was completed on 12/08/22. A document from Entity #1, dated 9/30/22, titled "Physician Order Details", indicated wound care/treatment frequency for each lower leg was ordered to be done every other day. A document for certification period 10/07/22 - 12/05/22, titled "Home Health Certification and Plan of Care" evidenced the document was a draft (not completed), skilled nursing was ordered, diagnoses included chronic venous hypertension (a condition that results from weakened lower extremity veins that have lost their ability to return blood to the heart, which causes high blood pressure in the legs), and chronic non-pressure ulcers (wounds caused by insufficient blood flow, or poor circulation) to both lower legs; and allergies included erythromycin (antibiotic) and adhesive tape. The plan of care failed to evidence Entity #1 managed the patients wounds, entity #1 ordered wound care every other day, or allergies also included penicillin. Medications on the plan of care included triamcinolone cream to be applied 3 times daily to both lower legs, milk of magnesia every 6 hours as needed for constipation, and tramadol 3 times daily for pain. The plan of care failed to evidence triamcinolone cream was discontinued, or the patient currently used over the counter moisturizer lotion to both lower legs. Supplies/equipment on the plan of care failed to evidence elastic compression wraps, elastic gauze wraps, incontinence pads, abdominal pads (thick cotton pads to absorb drainage), cane, or wheelchair. Interventions on the plan of care included to evaluate the cardiopulmonary, nutrition, hydration, elimination statuses, and signs/symptoms of infection; teach disease process, diet, home safety/fall prevention, signs and symptoms of infection, medications; wound care site was the left groin, measure wound(s) weekly, teach wound care/dressing. The plan of care failed to include interventions to mitigate pain or constipation, or exacerbation of chronic venous hypertension. Goals on the plan of care stated “... Demonstrates compliance with medication by 2 weeks (date) [no date entered] ... Stabilization of cardiovascular pulmonary condition by 2 weeks (date) [no date entered] ... Demonstrates competence in following medical regime by 2 weeks (date) [no date entered] ... Pain controlled at acceptable level by end of cert [certification] period (date) [no date entered] ... Demonstrates independence in skin care by end of cert [certification] period (date) [no date entered] ... Wound healing without complications by end of cert [certification] period (date) [no date entered] ...." The plan of care failed to evidence patient stated goals, or patient-specific measurable outcomes/goals for constipation, exacerbation of chronic venous hypertension, or new/worsening wounds. During an interview on 12/08/22 at 1:10 PM, the Clinical Manager indicated they didn't do every other day visits because they don't work weekends, the patient was seen by the agency for wound care ordered by the wound clinic (Entity #1), Person #11 was not part of Entity #1, he was the PCP, the plans of care were autogenerated, and stuff was missing. 8. Clinical record review for patient #7 was completed on 12/09/22 (start of care date 11/09/22). A document dated 10/26/22 titled "Home Care- Start of Care Orders ....", indicated the patient had a new colostomy (a surgical operation in which a piece of the colon is diverted to an artificial opening in the abdominal wall so as to bypass a damaged part of the colon to drain waste) placed 10/25/22, port-a-cath (a surgically implanted device which allows easy access to a patient's veins) placement 10/25/22, and had colon cancer. A document dated 11/03/22, titled "Progress Notes", indicated Paragon Home Health Care accepted the patient for services, the patient had a port-a-cath to the left upper chest with steri-strips (porous surgical tape strips used to close small wounds) in place, patient was on a full liquid diet (includes all foods that are liquid or will turn to liquid at room or body temperature), needs included home health care for negative pressure wound treatment, colostomy and Jackson Pratt (JP) drain (a closed-suction medical device that is commonly used as a post-operative drain for collecting bodily fluids from surgical sites) care/teaching. A document titled "Home Health Certification and Plan of Care" (certification period 11/09/22 - 1/07/23) evidenced skilled nursing was ordered; medications included colace (a stool softener) twice daily and ondanestron (to resolve nausea) every 6 hours as needed; supplies included negative pressure wound therapy (NPWT) equipment (a power operated device with a suction pump, tubing and a dressing to remove excess wound drainage and promote healing), but failed to evidence dressing supplies needed for the NPWT; and an ostomy (not specified as colostomy) pouch, but failed to evidence the size of the pouch the patient used, or any other required colostomy supplies to maintain the colostomy. The plan of care failed to evidence the patient had a port-a-cath, or the patient's ordered diet. Interventions/orders on the plan of care included SN (skilled nurse) for assessment, wound care, ostomy teaching, instruct ostomy care, and monitor JP drain site for signs of infection; and risk of hospitalization; and included the patient took 5 or more medications. The plan of care failed to evidence nursing interventions to reduce the risk of hospitalization, for care/management the colostomy, JP drain, or port-a-cath; location of the colostomy, JP drain, or port-a-cath; teaching interventions to prevent colostomy complications, signs and symptoms of the stoma (the surgical opening of the colostomy) that must be immediately reported to nurse/physician, or when to go directly to the emergency department (ED), full liquid diet, mitigation of nausea, how to properly evacuate the JP drain, JP drain precautions, or signs and symptoms of infection to the port-a-cath site. Two goals were evidenced on the plan of care, which stated, "... Patient and significant other will become independent in ostomy care by 12/31/2022 ... Abdomen wound will heal by 12/31/2022 ..." The plan of care failed to evidence patient stated goal(s), or any other goals related to infection prevention/control, patency of the colostomy, removal of the JP drain, dietary advancement, or wound healing. During an interview on 12/09/22 at 2:30 PM, Employee #6 indicated the plan of care and other orders weren't completed or signed by the physician. The alternate Clinical Manager indicated the plan of care was a "hot mess", and it was "missing everything". 9. A home visit was observed with Patient #8 and HHA #1 on 12/07/22 from 11:15 AM - 12:00 PM. The patient was pleasant and confused. The patient's medications were reviewed with family (primary caregiver, who administered all medications), who indicated the medication list on the plan of care was a "super old" medication list, and it was from before she ever had home care, like when she was in the nursing home. Family indicated the patient didn't take norco (narcotic pain relief), or use any skin barrier cream as indicated on the plan of care. Family indicated the patient's current medications included: Aleve (over the counter [OTC], nonsteroidal anti-inflammatory drug used to treat pain) 220 mg (milligrams) with 2 tabs of tylenol 325 mg, both 2-3 times daily, and tramadol 50 mg. Family stated, "... She takes it [tramadol] when it rains ...." Informed family the bottle of tramadol expired 5/17/22. Additional medications included guanfacine (used to treat attention deficit hyperactivity disorder and high blood pressure), esomeprazole magnesium (an anti-acid), Vitamin D3, 1000 IU (International Unit) every morning, senna plus every morning unless loose stools, and humalog sliding scale 100 U (Units)/ml (milliliter): family checked patient's blood sugar level 4 times daily- before meals and bedtime; for blood sugar level less than 60, call physician, 110-125= 1U (Unit), 126-140= 2U, 141-160= 3U, 161-180= 4U, 181-200= 5U, 201-240= 6U, 241-280= 7U, 281-320= 8U, 321-360= 9U, greater than 360= 10U and call physician. Clinical record review for Patient #8 was completed on 12/09/22. A document titled "Home Health Certification and Plan of Care" (certification period 11/09/22 - 1/07/23) failed to evidence the patient's medications included Aleve 220 mg with 2 tabs of tylenol 325 mg, both 2-3 times daily, and tramadol 50 mg "when it rains", guanfacine, esomeprazole magnesium, Vitamin D3, 1000 IU every morning, senna plus every morning unless loose stools, and humalog sliding scale 100 U (Units)/ml (milliliter): family checked patient's blood sugar level 4 times daily- before meals and bedtime; for blood sugar level less than 60, call physician, 110-125= 1U (Unit), 126-140= 2U, 141-160= 3U, 161-180= 4U, 181-200= 5U, 201-240= 6U, 241-280= 7U, 281-320= 8U, 321-360= 9U, greater than 360= 10U and call physician. The plan of care failed to evidence the patient's current medication list. During an interview on 12/09/22 at 1:19 PM, the Administrator indicated he expected the nurses to check the patient's medications every visit, and indicated the agency's EMR software wouldn't allow them to update the medication list. The alternate Clinical Manager indicated she expected to see all supplies and equipment on the plans of care, and interventions and goals should be patient-specific, based on the diagnoses. The Administrator then indicated the EMR was the problem, and the alternate Clinical Manager indicated patient #8’s plan of care didn't look good. When queried how the contents of the plans of care were determined, the Administrator indicated he wasn't clinical, so he couldn't answer that. The alternate Clinical Manager indicated the plan of care should be based on the comprehensive assessment and diagnoses.

Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the patient's plan of care was reviewed by the certifying physician, for 4 of 4 clinical records reviewed where a significant change in condition occurred that required an updated plan of care (#1, 3, 4, 5); and failed to ensure the patient's plan of care was reviewed by the certifying physician at least every 60 days, for 2 of 4 clinical records reviewed with more than one certification period (#3, 4). Findings include: 1. An agency policy with revised date February 2022, titled "Plan of Care ... and Physician/Practitioner Orders", indicated each Plan of Care must be signed and dated by the physician, and the plan of care must be established and periodically reviewed every 60 days, or more frequently when indicated by changes in the patient's condition. 2. Clinical record review for Patient #1 was completed on 12/06/22 (Start of care date 10/12/22). A document received 11/30/22, titled "Home Health Certification and Plan of Care" for certification period 10/12/22 - 12/10/22, indicated the document was a "draft", and failed to evidence the patient had a diagnosis of seizures. A document dated 10/18/22, titled “Home Discharge Instructions”, evidenced the patient was hospitalized at Entity #10 from 10/15/22 – 10/18/22, for seizures. This document evidenced the patient experienced a significant change in condition which required an updated plan of care. A document received 12/02/22, titled "Home Health Certification and Addendum to Plan of Care" for certification period 10/12/22 - 12/10/22, evidenced the document was a “draft”, the resumption of care date was 10/19/22, and failed to evidence the document was completed, signed by an agency licensed skilled professional, or by the certifying physician. During an interview on 12/06/22 at 1:47 PM, the Administrator indicated there were no signed orders from any physician for Patient #1. During an interview on 12/06/22 at 2:00 PM, when queried what was considered to be the updated plan of care, the Clinical Manager stated "... We get orders and they stay separate from the plan of care ...." When queried how the patient's plan of care was created, the Clinical Manager stated, "It autogenerates ... We have to add some stuff ... It picks up what it wants ...." 3. Clinical record review for Patient #3 was completed on 12/08/22 (start of care date 1/31/22). The EMR evidenced a document titled "Home Health Certification and Plan of Care” for recertification period 4/01/22 – 5/30/22, which was signed by the certifying physician and received by the agency on 5/31/22. The EMR failed to evidence any subsequent Plans of Care were completed or sent to the certifying physician. Documents titled "Home Health Certification and Plan of Care", for certification periods 5/31/22 – 7/29/22, 7/30/22 – 9/27/22, 9/28/22 – 11/26/22, and 11/27/22 – 1/25/23, indicated they were “In Progress”. A document received from Entity #1 on 12/02/22, dated 10/17/22, titled “Discharge Summary”, evidenced the patient was hospitalized from 10/10/22 – 10/17/22, due to a new infected wound, and osteomyelitis (inflammation of bone caused by infection). This document evidenced the patient experienced a significant change in condition and required an updated plan of care. A document dated 10/18/22, titled “Medical Authorization/Verbal Order”, evidenced the order was written by Person #15, who wasn’t the Patient’s certifying physician. The order indicated the patient had a peripherally inserted central catheter (PICC) line (long catheter that is inserted through a peripheral vein, often in the arm, into a larger vein in the body, used when intravenous treatment is required over a long period). Orders included use/management of the PICC line, intravenous (IV) antibiotics to be administered at least daily from 10/18/22 through 11/29/22, and weekly lab draws. This document also evidenced the patient experienced a significant change in condition which required an updated plan of care. A document received on 12/08/22, not signed/dated by agency staff, titled "Home Health Certification and Addendum to Plan of Care", evidenced the document was a “draft”, the resumption of care date was 10/18/22, and indicated it was “In Progress”. During an interview on 12/08/22 at 2:30 PM, the Clinical Manager indicated documents marked in the EMR as “drafts” and/or “In Progress” were incomplete documents, and were not yet sent to the physician for review/signature. 4. Clinical Record review for Patient #4 was completed on 12/09/22 (start of care date 1/26/22). A document dated 9/21/22, titled “Recertification”, stated, “... wounds have healed ... discharged from wound clinic ....” A document for certification period 9/23/22 – 11/21/22, titled "Home Health Certification and Plan of Care" failed to evidence the patient had any wounds. A document dated 10/19/22, titled Skilled Nurse Visit”, indicated the patient had a new venous stasis ulcer (a wound caused by impaired circulation). This document evidenced the patient experienced a significant change in condition which required an updated plan of care. The EMR failed to evidence an updated plan of care. A document dated 10/19/22 at 10:59 PM, titled “Change Visit Frequency”, stated, “... Physicians Orders ... change the SN [skilled nursing] frequency to 3 times a week ... for wound care to the [left] lower limb for venous stasis ulcer ....” The EMR failed to evidence the order was sent to, or signed by the certifying physician. A document dated 11/21/22, titled “Recertification" indicated the skilled nurse performed wound care/treatment to the patient’s left lower leg stasis ulcer. A document received 11/30/22, for certification period 11/22/22 - 1/20/23, titled "Home Health Certification and Plan of Care" evidenced the document was a “Draft”, failed to evidence signatures from a licensed skilled professional or the certifying physician, and failed to evidence it was sent to the certifying physician; and failed to evidence the plan of care was updated to include diagnosis of venous stasis ulcer, increased nursing visit frequency, or any wound care orders. During an interview on 12/09/22 at 1:41 PM, Employee #6 indicated the plan of care and other orders in the EMR were incomplete and that’s why they haven’t been sent to the physician for review/approval and signature. 5. Clinical record review for Patient #5 was completed on 12/09/22 (start of care date 9/06/22). A document received from Entity #14 (a hospital) on 12/08/22, titled “Medical Chart Patient Admission”, evidenced the patient was admitted 9/21/22, discharged 9/22/22, and stated, “... Admitting Diagnosis ... Acute [sudden onset] Hypotension [low blood pressure] ... AFib [atrial fibrillation, an irregular heart rhythm] ....” A document received from Entity #14 on 12/08/22, titled “Discharge Summary”, evidenced the patient required emergent treatment for cardiac conditions and medications were changed. This document evidenced the patient experienced a significant change in condition which required an updated plan of care. A document for certification period 9/06/22 - 11/04/22, titled “Home Health Certification and Addendum to Plan of Care”. The EMR evidenced the document was “In Progress”, and failed to evidence it was sent to the certifying physician. During an interview on 12/09/22 at 2:26 PM, the alternate Clinical Manager indicated the plan of care should be updated with new frequency orders, and every time the orders changed, the plans of care should be updated.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the Administrator failed to ensure agency personnel followed infection control precautions for the prevention/control of infection/communicable disease (Please see tag G0682); and failed to track and document the COVID-19 vaccination status of all agency personnel, and/or track and document if agency personnel received any COVID-19 booster doses (Please see tag G0687). This practice had the potential to affect all patients serviced by the agency. The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.70: Infection Prevention and Control.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the Administrator failed to ensure agency personnel followed infection control precautions for the prevention/control of infection/communicable disease for 3 of 3 home visits observed (Patient #2, 6, 9). Findings include: 1. An agency policy with revised date July 2021, titled "Exposure Control Plan: OSHA [The Occupational Safety and Health Administration] Regulations", stated, "... All solutions will be checked for expiration date prior to use ... Other disposable ... solution containers will be discarded after use ...." 2. An agency policy with revised date July 2021, titled "Hand Hygiene Policy and Compliance Program", stated, "... When using [hand sanitizer] ... the procedure is as follows ... Place adequate amount ... on hands ... Using friction, clean ... until hands are completely dry ...." 3. An agency policy dated February 2022, titled "COVID-19 Vaccine Mandate Policy", stated, "... If an employee ... is not fully vaccinated ... will be required to ... Use a NIOSH [National Institute of Occupational Safety and Health]-approved N95 or equivalent or higher-level respirator ...." 4. Review of a CDC web base reference on 12/05/22, updated 8/10/21, https://www.cdc.gov/handwashing/hand-sanitizer-use.html, titled "Hand Sanitizer Use Out and About", stated, "... Put enough sanitizer on your hands to cover all surfaces ... Rub your hands together until they feel dry (this should take around 20 seconds) ...." 5. A home visit was observed with Patient #2 and the Clinical Manager on 12/05/22 from 2:15 PM - 3:00 PM. Observed the Clinical Manager cleanse the patient's wound with a bottle of previously opened normal saline (NS, sterile salt water). The bottle was not marked with the date it was originally opened (NS should be discarded within 28 days of being opened). During an interview on 12/05/22 at 2:40 PM, the Clinical Manager indicated the NS was previously opened, she wasn't sure when, it wasn't marked, and it "usually lasts around 2 weeks". 6. A home visit was observed with Patient #6 and the Clinical Manager on 12/05/22 from 11:00 AM - 12:00 PM. The Clinical Manager perform hand hygiene with hand sanitizer for 8 seconds, hands remained wet, and she reached into her nursing bag to remove a manual blood pressure cuff. At 11:24 AM, the Clinical Manager removed the soiled dressing from the patient's right lower leg, failed to perform hand hygiene, removed the soiled dressing from the patient's left lower leg, performed hand hygiene for 10 seconds, hands remained wet, and reached into shirt pocket to retrieve clean gloves. Neither of the patient's intact skin on the lower legs was cleansed after removal of old dressings, or prior to application of moisturizing cream. At 11:36 AM, the Clinical Manager performed hand hygiene for 11 seconds, put her wet hand into her pocket, and donned gloves with difficulty. The Clinical Manager sprayed a commercial bottle labeled "Wound Cleanser" onto a hydrofera blue dressing (a bacteriostatic dressing), and indicated the bottle was not filled with wound cleanser, it was actually NS she previously opened and poured into the used wound cleanser bottle. 7. A home visit was observed with Patient #9 and Home Health Aide (HHA) #1 on 12/07/22 from 11:00 AM - 12:15 PM. HHA #1 wore a disposable paper mask during the home visit. Personnel record review for HHA #1 was completed on 12/01/22, which failed to evidence proof HHA #1 was vaccinated for COVID-19. During an interview on 12/01/22 at 12:10 PM, Employee #6 and the Clinical Manager both indicated HHA #1's personnel record failed to include proof HHA #1 was fully vaccinated for COVID-19.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to track and document the COVID-19 vaccination status of all agency personnel, and/or track and document if agency personnel received any COVID-19 booster doses, for 10 of 12 personnel records reviewed that did not have documented proof of exemption for COVID-19 vaccination(s) (Licensed Practical Nurse [LPN] #1, Home Health Aide #1, HHA #2, Registered Nurse [RN] #1, RN #2, alternate Clinical Manager, Certified Occupational Therapy Assistant [COTA] #1, Physical Therapist [PT] #1, PT #2, Physical Therapy Assistant [PTA] #3). Findings include: 1. An agency policy dated February 2022, titled "COVID-19 Vaccine Mandate Policy", stated, "... Agency will ensure that all ... staff have received the applicable vaccine prior to providing care, treatment or services for the agency and/or its patients. Agency will maintain acceptable proof/documentation of vaccination status ... Agency will also track and document any booster doses ... If an employee ... is not fully vaccinated ... will be required to ... Be tested at least weekly ... Use a NIOSH [National Institute of Occupational Safety and Health]-approved N95 or equivalent or higher-level respirator ... Agency will maintain a list of all staff and their vaccination status which includes ... The percent of unvaccinated staff, excluding those staff that have approved exemptions ...." 2. Personnel records were reviewed on 12/01/22 from 11:47 AM - 1:00 PM with the Clinical Manager and Person #6 (office staff): LPN #1's personnel record (date of hire 7/29/22, first patient contact 7/30/22) failed to evidence any proof LPN #1 was fully vaccinated for COVID-19, or received any booster doses. RN #1's Personnel record (date of hire 9/29/22, first patient contact 9/29/22) failed to evidence any proof RN #1 was fully vaccinated for COVID-19, or received any booster doses. RN #2's personnel record (date of hire 4/27/22, first patient contact 4/27/22) failed to evidence any proof RN #1 was fully vaccinated for COVID-19, or received any booster doses. HHA #1's personnel record (date of hire 1/06/21, first patient contact 1/08/21) failed to evidence any proof CNA #1 was fully vaccinated for COVID-19, or received any booster doses. HHA #2's personnel record (first patient contact 9/07/22) failed to evidence if CNA #2 received any COVID-19 booster doses. 3. During an interview on 12/08/22 at 3:16 PM, the Administrator indicated the alternate Clinical Manager was a new hire. 4. During an interview on 12/08/22 at 3:16 PM, Employee #6 (office staff) indicated the alternate Clinical Manager was going to bring them (physical, TB test, COVID-19 vaccine card) in today (12/08/22), but she went home sick. 5. During an interview on 12/09/22 at 11:55 AM, the alternate Clinical Manager indicated she didn't tell anyone she planned on dropping off her COVID-19 vaccine card yesterday (12/08/22). 6. Contracted personnel records were reviewed with the Administrator on 12/06/22 from11:32 AM – 12:00 PM. COTA #1's personnel file (no date of hire, no first patient contact date) failed to evidence if COTA #1 received any COVID-19 booster doses. PT #1's personnel file (no date of hire, no first patient contact date) failed to evidence if PT #1 received any COVID-19 booster doses. PT #2's personnel file (no date of hire, no first patient contact date) failed to evidence if PT #2 received any COVID-19 booster doses. PTA #3's personnel file (no date of hire, no first patient contact date) failed to evidence any proof CNA #1 was fully vaccinated for COVID-19, or received any booster doses. During an interview on 12/06/22 at 11:32 AM, the Administrator indicated Entity #4 (contracted therapy services) never sends the complete personnel file.

Development and evaluation of plan of care CFR(s): 484.75(b)(2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the Registered Nurse (RN) failed to review the plan of care in partnership with the patient and/or caregiver for 2 of 2 home visits observed with an RN (#2, 6). Findings include: 1. An agency policy with revised date February 2022, titled "Plan of Care ....", stated, "... plan of care must be reviewed and revised ... no less frequently than every 60 days ... Revisions to the plan of care ... must be communicated to the patient, representative ...." 2. Clinical record review for Patient #2 was completed on 12/08/22 (start of care date 8/08/22). A document for certification period 10/07/22 - 12/05/22, titled "Home Health Certification and Plan of Care" evidenced the patient required a review/evaluation of the plan of care for recertification of services between 12/01/22 and 12/05/22. A home visit was observed with Patient #2 and the Clinical Supervisor on 12/05/22 from 2:15 PM - 3:00 PM, with family (primary caregiver) also present. The Clinical Manager failed to review the patient's plan of care with the patient/family. During an interview on 12/08/22 at 12:03 PM, the Clinical Manager indicated the home visit for patient #2 on 12/05/22 was a comprehensive reassessment for recertification of home care services, and she didn't review the plan of care with the patient/family during the recertification visit. 3. Clinical record review for Patient #6 was completed on 12/08/22 (start of care date 10/07/22). A document for certification period 10/07/22 - 12/05/22, titled "Home Health Certification and Plan of Care" evidenced the patient required a review/evaluation of the plan of care for recertification of services between 12/01/22 and 12/05/22. A home visit was observed with Patient #6 and the Clinical Manager on 12/05/22, from 11:00 AM - 12:05 PM. The Clinical Manager failed to review the patient's plan of care with the patient/family. During an interview on 12/08/22 at 1:10 PM, the Clinical Manager indicated the home visit for patient #6 on 12/05/22 was a comprehensive reassessment for recertification of home care services, and she didn't review the plan of care with the patient/family during the recertification visit. 4. During an interview on 12/09/22 at 2:00 PM, the Administrator indicated he expected the nurse to create a new plan of care, and review goals again.

Patient and caregiver education CFR(s): 484.75(b)(5) Patient and caregiver education; This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the Registered Nurse failed to provide patient and/or caregiver education as ordered on the patient's plan of care, for 2 of 2 home visits observed with an RN (#2, 6). Findings include: 1. An agency policy with revised date February 2017, titled "Professional Standards of Practice", stated, "... Agency staff will provide care, treatment and services to each patient according to the plan of care ...." 2. Clinical record review for Patient #2 was completed on 12/08/22 (start of care date 8/08/22). A document for certification period 10/07/22 - 12/05/22, titled "Home Health Certification and Plan of Care" evidenced the patient's primary diagnosis was diabetes, and an additional diagnosis of a chronic non-pressure ulcer to the right ankle, and unspecified systolic (congestive) heart failure (impairment of the left side of the heart); skilled nursing orders included to teach disease process and diet. A home visit was observed with Patient #2 and the Clinical Manager on 12/05/22 from 2:15 PM - 3:00 PM. The Clinical Manager indicated the patient had 1 wound on the right lateral (outside) ankle, to which she provided wound care/treatment. Observed the patient's left foot was swollen, dark red/purple in color (indicative of impaired circulation), had several small raised blisters on the 2nd toe, and 2 dark purple areas on the ball (bottom, where the toes attach to the foot) of the left foot, by the great and 5th toe joints. The Clinical Manager indicated the left foot was like that for the last couple of weeks. The Clinical Manager failed to provide skilled teaching related to prevention of new or worsening wounds or elevation of legs to reduce swelling and improve circulation. During an interview on 12/08/22 at 12:03 PM, the Clinical Manager indicated the home visit for patient #2 on 12/05/22, was a comprehensive reassessment for recertification of home care services, and stated, "... No, I didn’t teach anything during the visit ... I taught him in the past ...." 3. Clinical record review for Patient #6 was completed on 12/08/22 (start of care date 10/07/22). A document for certification period 10/07/22 - 12/05/22, titled "Home Health Certification and Plan of Care" evidenced diagnoses included chronic venous hypertension (a condition that results from weakened lower extremity veins that have lost their ability to return blood to the heart, which causes high blood pressure in the legs), and chronic non-pressure ulcers (wounds caused by insufficient blood flow, or poor circulation) to both lower legs. Skilled nursing orders included to teach disease process and diet. A home visit was observed with Patient #6 and the Clinical Manager on 12/05/22, from 11:00 AM - 12:05 PM. The patient indicated she was concerned about her blood pressure being too high, and she didn't eat anything yet today. The Clinical Manager failed to provide skilled teaching related to the patient's complaint of high blood pressure, or dietary requirements included eating 3 well balanced meals daily, and importance of good nutritional intake to promote wound healing. During an interview on 12/08/22 at 1:10 PM, the Clinical Manager indicated the home visit for patient #6 on 12/05/22, was a comprehensive reassessment for recertification of home care services, and indicated she didn't provide any skilled teaching during the home visit.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the Registered Nurse (RN) failed to ensure the Home Health Aide (HHA) provided care/services as ordered/included on the plan of care for 3 of 3 clinical records reviewed with patients who received HHA services (#1, 5, 8). Findings include: 1. An agency job description with revised date 2008, titled "Home Health Aide (HHA)", stated "... Responsibilities ... Performs personal care and bath as ordered ... Reports changes in the patient's condition and needs to the RN [Registered Nurse] ...." 2. Clinical record review for Patient #1 was completed on 12/06/22 (Start of care date 10/12/22). A document received 11/30/22, titled "Home Health Certification and Plan of Care" for certification period 10/12/22 - 12/10/22, indicated the document was a "draft", Home Health Aide (HHA) services were ordered twice weekly for 8 weeks, and stated, "... [HHA] for personal care and ADL [activities related to personal care, such as bathing or showering, dressing, getting in and out of bed or a chair, walking, using the toilet, and eating]. The initial plan of care failed to evidence specific tasks the HHA should perform with the patient. The electronic medical record (EMR) failed to evidence an HHA plan of care with specific tasks the HHA should perform with the patient. During an interview on 12/06/22 at 2:00 PM, the Clinical Manager indicated she previously saw a HHA plan of care in the EMR for Patient #1, but could not find it now. When queried what was considered to be the updated plan of care, the Clinical Manager stated "... We get orders and they stay separate from the plan of care ...." 3. Clinical record review for Patient #5 was completed on 12/09/22 (start of care date 9/06/22). A document for certification period 9/06/22 - 11/04/22, titled "Home Health Certification and Plan of Care" failed to evidence HHA services were ordered. A document received from Entity #14 (a hospital) on 12/08/22, titled “Medical Chart Patient Admission”, evidenced the patient was admitted 9/21/22, and discharged 9/22/22. A document for certification period 9/06/22 - 11/04/22, dated 9/26/22, titled “Home Health Certification and Addendum to Plan of Care”, failed to evidence HHA services were ordered. The EMR evidenced documents titled "Home Health Aide Visit Record" for dates 10/18/22, 10/25/22, 10/28/22, 11/01/22, and 11/04/22, but failed to evidence orders for HHA services. During an interview on 12/09/22 at 2:26 PM, the alternate Clinical Manager indicated the plan of care should be updated with new orders, and every time the orders changed, the plans of care should be updated. 4. Clinical record review for Patient #8 was completed on 12/09/22 (start of care date 8/11/22). A document dated 10/05/22, titled "Home Health Aide Care Plan", indicated tasks assigned by the RN to be completed every HHA visit included shampoo hair and nail care. A document dated 12/07/22, titled "Home Health Aide Visit Record", failed to evidence the HHA shampooed the patient's hair, or performed nail care; and failed to evidence the RN was notified. A home visit was observed with Patient #8 and HHA #1 on 12/07/22 from 11:15 AM - 12:00 PM. The Patient indicated she was freezing cold, and did not want her hair washed. HHA #1 did not wash the patient's hair or perform nail care. During an interview on 12/09/22 at 1:19 PM, the alternate Clinical Manager indicated the HHA should be doing everything on the aide care plan, the HHA should notify the RN if something on the care plan wasn't completed, and it should be documented; indicated the HHA failed to document nail care or shampoo hair; and indicated the HHA should document if the patient refused a task ordered on the aide plan of care, document the reason why the patient refused, and document that the nurse was notified.

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure the Administrator was responsible for all day-to-day operations of the home health agency (Please see tag G0948); the Clinical Manager provided oversight of all patient care services and personnel (Please see tag G0958); the Clinical Manager failed to provide oversight of patient and personnel assignments (Please see tag G0960); the Clinical Manager failed to ensure coordination of care occurred with other agency personnel, physician(s), and other entities who provided care/treatment to meet the patient's needs (Please see tag G0962); the Clinical Manager evaluated each patient referral to determine the appropriateness for home care (Please see tag G0964); the Clinical Manager failed to ensure the patients' needs were assessed (Please see tag G0966); and the Clinical Manager failed to ensure clinical services were provided in accordance with current clinical practice guidelines and accepted professional standards of practice (Please see tag G0984). This practice had the potential to affect all patients serviced by the agency. The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.105: Organization and Administration of Services.

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the Administrator failed to be responsible for all day-to-day operations of the home health agency. Findings include: The Administrator failed to ensure the Registered Nurse (RN) conducted the initial evaluation within 48 hours of referral to determine eligibility for the Medicare home health benefit, including homebound status. Please see tag G0514. The Administrator failed to ensure a comprehensive assessment including the administration of the OASIS (Outcome and Assessment Information Set) during the last 5 days of every 60 day certification period. Please see tag G0546. The Administrator failed to ensure a comprehensive assessment was completed for patients who were hospitalized during the certification period. Please see tag G0548. The Administrator failed to ensure a comprehensive assessment was completed upon discharge. Please see tag G0550. The Administrator failed to ensure agency personnel followed infection control precautions for the prevention/control of infection/communicable disease. Please see tag G0682. The Administrator failed to track and document the COVID-19 vaccination status of all agency personnel, and/or track and document if agency personnel received any COVID-19 booster doses. Please see tag G0687. The Administrator failed to ensure the RN reviewed the plan of care in partnership with the patient and/or caregiver. Please see tag G0708. The Administrator failed to ensure the RN provided the patient and/or caregiver education as ordered on the patient's plan of care. Please see tag G0714. The Administrator failed to ensure the Home Health Aide (HHA) provided care/services as ordered/included on the plan of care. Please see tag G0800. The Administrator failed to ensure the Clinical Manager was available during all operating hours. Please see tag G0950. The Administrator failed to ensure the Clinical Manager provided oversight of all patient care services and personnel. Please see tags G0958, G0960, G0962, G0964, G0966, and G0984. The Administrator failed to ensure all clinical records were documented accurately, and adhered to current clinical record documentation standards of practice. Please see Tag G1008. The Administrator failed to ensure the clinical record evidenced the name/contact information for the patient's primary care physician/practitioner (Please see tag G1020); The Administrator failed to ensure a transfer and/or discharge summary completed and sent to the appropriate physician/practitioner and/or or receiving facility. Please see tag G1022. The Administrator failed to retain all patients' clinical records per State/Federal regulation. Please see tag G1026. The Administrator failed to ensure it safeguarded all patients' clinical record information against loss or unauthorized use. Please see tag G1028.

Ensure clinical manager is available CFR(s): 484.105(b)(1)(iii) (iii) Ensure that a clinical manager as described in paragraph (c) of this section is available during all operating hours; This ELEMENT is not met as evidenced by: Based on record review, and interview, the home health agency failed to ensure the Clinical Manager was available during all operating hours. Findings include: An agency job description with revised date February 2022, titled "Director of Clinical Services", stated, "... the Director of Clinical Services [Clinical Manager] is available at all times during operating hours (or appoints a similarly qualified alternate) ...." An agency policy revised February 2022, titled "After Hours Accessibility" stated, "... The [Clinical Manager] ... and/or ... [alternate Clinical Manager] is on-call 24 hours per day on a rotating weekly basis ...." An agency job description submitted 12/06/22, revised February 2022, titled "Clinical Manager [alternate Clinical Manager]", stated, "... Available to share on-call ... Acts as [Clinical Manager] in the [Clinical Manager's] absence ...." During an interview on 11/30/22 at 11:04 AM, the Administrator indicated Registered Nurse (RN) #3 (alternate Clinical Manager) was on vacation until 12/15/22. During an interview on 12/09/22 at 11:53 AM, the Administrator indicated RN #3 (alternate Clinical Manager)was actually retired. During an interview on 12/08/22 at 3:30 PM, the Clinical Manager indicated she was leaving on a flight this evening, and would be back at work on Monday (12/12/22). When queried who would cover RN Clinical Manager duties in her absence, the Clinical Manager indicated no one did, this was how the agency operated; if she wasn't available, no one covered; and patients had to wait until she returned. During an interview on 12/08/22 at 8:15 PM, the Administrator indicated there was not a RN available to participate in the survey process for clinical record review on Friday, 12/09/22 during regular business hours. During an interview on 12/08/22 at 8:38 PM, RN #1 indicated they (agency) didn't work weekends as a standard practice, she only agreed to be on call to help out this evening (12/08/22), and she had another full time job, Monday - Friday, 8:00 AM to 5:00 PM, and some weekends/evenings. During an interview on 12/09/22 at 12:28 PM, Employee #6 (Office staff) indicated she worked at the agency for just over a year, she never met RN #3, and RN #3 wasn't really available, When queried the last time RN #3 saw agency patients or was involved with agency daily operations, administrative Employee #6 stated, "... I would probably say it was probably before I began ...." During an interview on 12/09/22 at 1:01 PM, when queried who was delegated to act on behalf of the Clinical Manager during her absence, the Administrator indicated RN #1 was. When queried what would happen if a patient needed an RN before 5:00 PM, the Administrator indicated they would let them wait.

Clinical manager CFR(s): 484.105(c) Standard: Clinical manager. One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following-- This STANDARD is not met as evidenced by: Based on record review and interview, the Clinical Manager failed to provide oversight of all personnel, for 13 of 13 personnel records reviewed (Licensed Practical Nurse [LPN] #1, LPN #2, Certified Nursing Assistant [CNA] #1, CNA #2, Registered Nurse [RN] #1, RN #2, Clinical Manager, alternate Clinical Manager, Certified Occupational Therapy Assistant [COTA] #1, Occupational Therapist [OT] #2, Physical Therapist [PT] #1, PT #2, Physical Therapy Assistant [PTA] #3). Findings include: 1. An agency policy with revised date February 2021, titled "Coordination of Patient Care" stated, "... The Director of Clinical Services [Clinical Manager] provides oversight of all patient care services. Oversight includes ... Coordinating patient care ... Coordinating referrals ... Ensuring that patient needs are continually assessed ... Ensuring the development, implementation and updates of the individualized plan of care ... Provides the physician/practitioner with ... changes in condition ...." 2. An agency job description with revised date February 2010, signed by the Clinical Manager on 8/10/21, titled "Clinical Director", indicated the Clinical Manager (Clinical Director) was responsible for the overall management of home health clinical services, hires and evaluates agency personnel, implements and evaluates the orientation program for new personnel, and oversees the maintenance of patient clinical records. 3. An agency policy with revised date February 2022, titled "Personnel Records", evidenced personnel records will include verification of certification and/or licensure and employee orientation, PPD tests (Purified protein derivative standard) (tuberculosis [TB] skin test) or chest x-ray results. 4. An agency policy with revised date February 2022, titled "Occupational Exposure to Tuberculosis ....", stated, "... During the pre-employment physical employees ... will have baseline PPD skin testing performed ... Employees with positive PPD test results should have a chest [x-ray] as part of the initial evaluation of the PPD test ...." 5. An agency document received 12/06/22, effective date 1/01/22, titled "Paragon Home Health Care Contractor Agreement", stated"... The Contractor [Entity #4, contracted therapy services] shall perform [sic] to all administrative and personnel policies of agency including personnel and health qualifications ...." 6. Personnel records were reviewed on 12/01/22 from 11:47 AM - 1:00 PM with the Clinical Manager and Person #6 (office staff): LPN #1's personnel record (date of hire 7/29/22, first patient contact 7/30/22) failed to evidence LPN #1's license was current, agency/job specific orientation was completed, or any TB testing was completed. RN #1's Personnel record failed to evidence a signed job description. RN #2's personnel record (date of hire 4/27/22, first patient contact 4/27/22) failed to evidence agency/job specific orientation was completed, or any TB testing was completed. The Clinical Manager's personnel record (date of hire 8/5/18, first patient contact 8/15/18) failed to evidence agency/job specific orientation was completed, or any TB testing was completed. LPN #2's personnel record (date of hire 12/30/18, first patient contact 1/03/19) failed to evidence any TB testing was completed in 2018, 2019, 2020, or 2021. CNA #1's personnel record (date of hire 1/06/21, first patient contact 1/08/21) failed to evidence any TB testing was completed. CNA #2's personnel record (first patient contact 9/07/22) failed to evidence any baseline TB testing was completed upon hire. 7. Personnel record for the alternate Clinical Manager (date of hire 12/01/22) was reviewed on 12/09/22 at 11:55 AM, which failed to evidence agency/job specific orientation was completed, or baseline TB testing was completed upon hire. During an interview on 12/08/22 at 3:16 PM, the Administrator indicated the alternate Clinical Supervisor was a new employee. During an interview on 12/09/22 at 11:55 AM, the alternate Clinical Manager indicated she didn't receive orientation. During an interview on 12/08/22 at 3:16 PM, Employee #6 (office staff) indicated the alternate Clinical Manager was going to bring them (physical, TB test, COVID-19 vaccine card) in today (12/08/22), but she went home sick. During an interview on 12/09/22 at 11:55 AM, the alternate Clinical Manager indicated she didn't tell anyone she planned on dropping of a physical, COVID-19 vaccine card, or TB test yesterday, and the agency did not do TB testing upon hire. 8. Contracted personnel records were reviewed with the Administrator on 12/06/22 from11:32 AM – 12:00 PM. OT #1's personnel file (no date of hire, no first patient contact date) failed to evidence a job description, or agency/job specific orientation was completed. PT #1's personnel file (no date of hire, no first patient contact date) failed to evidence a job description, or agency/job specific orientation was completed. PT #2's personnel file (no date of hire, no first patient contact date) failed to evidence a job description, or agency/job specific orientation was completed. PTA #3's personnel file (no date of hire, no first patient contact date) failed to evidence a job description, or agency/job specific orientation was completed. During an interview on12/06/22 at 11:32 AM, the Administrator indicated Entity #4 (contracted therapy services) never sends the complete personnel file, and they only send what state required.

Make patient and personnel assignments, CFR(s): 484.105(c)(1) Making patient and personnel assignments, This ELEMENT is not met as evidenced by: Based on record review and interview, the Clinical Manager failed to provide oversight of patient and personnel assignments. Findings include: An agency policy with revised date February 2021, titled "Coordination of Patient Care" stated, "... The Director of Clinical Services provides oversight of all patient care services. Oversight includes ... Coordinating patient care ...." An agency job description with revised date February 2022, titled "Director of Clinical Services", stated, "... the Director of Clinical Services [Clinical Manager] ... participates in all activities relevant to professional services furnished, including ... assignment of personnel ...." An agency job description signed by Employee #7 (Referral/Intake Supervisor/Office Manager) and the Administrator on 9/10/18, titled "Referral/Intake Supervisor", stated "... Responsible for managing all aspects of the patient intake process ... Essential Job Functions ... Ensures seamless transition of patients to home care by providing direct oversight of patient education and preparation of home care, plan of care initiation, and coordination of care with multiple service providers ...." During an interview on 12/05/22 at 3:00 PM, The Clinical Manager indicated Employee #7 told her when to admit the patients, and she didn't know anything about newly referred patients until she was assigned to go admit them by Employee #7. When queried if Employee #7 was an RN or licensed practical nurse (LPN), the Clinical Manager stated, "... No ..." During an interview on 12/06/22 at 11:25 AM, Employee #7 indicated she notified the RN, called the patient, and set up a time to do the admission for home care services. During an interview on 12/06/22 at 1:37 PM, the Administrator indicated they (agency) didn't need an RN to do the patient "intake part", they had a Clinical Manager that Employee #7 could consult if she needed anything. The Clinical Manager indicated she was made aware of patient referrals only after everything was ready and insurance was cleared, Employee #7 would sent her the patient's information to do an admission visit.

Coordinate patient care CFR(s): 484.105(c)(2) Coordinating patient care, This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the Clinical Manager failed to ensure coordination of care occurred with other agency personnel, physician(s), and other entities who provided care/treatment to meet the patient's needs, for 2 of 2 home visits observed (#2, 6). Findings include: 1. An agency policy with revised date February 2021, titled "Coordination of Patient Care" stated, "... The Agency must ... Assure communication with all physicians/practitioners involved in the plan of care ... Coordinate care delivery to meet the patient's needs ...." 2. A home visit was observed with Patient #2 and the Clinical Manager on 12/05/22 from 2:15 PM - 3:00 PM. The Clinical Manager indicated the patient had 1 wound on the right lateral (outside) ankle, to which she provided wound care/treatment, and Entity #9 (a wound clinic) managed the patient's wound. Observed the patient's left foot was swollen, dark red/purple in color (indicative of impaired circulation), had several small raised blisters on the 2nd toe, and 2 dark purple areas on the ball (bottom, where the toes attach to the foot) of the left foot, by the great and 5th toe joints. The Clinical Manager indicated the left foot was like that for the last couple of weeks. The patient indicated he needed his toenails trimmed, and asked the Clinical Manager to trim them. The Clinical Manager indicated she couldn't trim them, but she'd have another agency nurse do it. Clinical record review for Patient #2 was completed on 12/08/22 (start of care date 8/08/22). A document for certification period 10/07/22 - 12/05/22, titled "Home Health Certification and Plan of Care" evidenced the patient's primary diagnosis was diabetes, and an additional diagnosis of a chronic non-pressure ulcer to the right ankle, and unspecified systolic congestive heart failure (impairment of the left side of the heart). A document dated 12/05/22, titled "Skilled Visit Note" failed to evidence the Clinical Manager coordinated care with another agency nurse or a podiatrist to ensure the patient's toenails would get trimmed, failed to evidence coordination with Entity #9 for new skin areas on the left foot/toes, and failed to evidence coordination with the patient's certifying physician (Person #19) for recertification of home care services. During an interview on 12/08/22 at 12:03 PM, the Clinical Manager indicated the home visit for patient #2 on 12/05/22 was a comprehensive reassessment for recertification of home care services, she didn't coordinate care with anyone to ensure the patient's toenails were trimmed, or coordinate with Entity #9 for new skin areas on the left foot/toes, because he went to wound clinic every other week, and they'd see it. The Clinical Manager also indicated there should be evidence she coordinated with the wound clinic on her start of care comprehensive assessment (8/08/22), as the patient was referred by Entity #9. 3. Clinical record review for Patient #6 was completed on 12/08/22 (start of care date 10/07/22). A document for certification period 10/07/22 - 12/05/22, titled "Home Health Certification and Plan of Care" evidenced diagnoses included chronic venous hypertension (a condition that results from weakened lower extremity veins that have lost their ability to return blood to the heart, which causes high blood pressure in the legs), and chronic non-pressure ulcers (wounds caused by insufficient blood flow, or poor circulation) to both lower legs, and skilled nursing frequency was once weekly for 1 week, 3 times weekly for 8 weeks (weeks 2-9), then once weekly for 1 week. The electronic medical record (EMR) evidenced a missed visit during the week of 10/16/22 (week 3), a missed visit during the week of 10/23/22 (week 4), and a missed visit during the week of 11/13/22 (week 7). A document dated 9/15/22, titled "Progress Note Details", evidenced Entity #12 (a wound clinic) ordered wound care to be performed every 2 days. A document dated 9/30/22, titled "Physician Orders Details", evidenced Entity #12 ordered wound care to be performed every 2 days. A document dated 10/28/22, titled "Physician Orders Details" evidenced Entity #12 ordered wound care to be performed every 2 days. A document dated 12/06/22, titled "Physician Orders Details" evidenced Entity #12 ordered wound care to be performed every 2 days. A home visit was observed with Patient #6 and the Clinical Manager on 12/05/22, from 11:00 AM - 12:05 PM. The patient indicated she was concerned that her blood pressure was high. The Clinical Manager indicated she would have another agency nurse bring out a log to record blood pressures. A document dated 12/05/22, titled "Skilled Visit Note" failed to evidence the Clinical Manager coordinated care with another agency nurse to ensure the patient received a blood pressure log, and failed to evidence coordination with the patient's certifying physician (Person #11) for recertification of home care services. During an interview on 12/08/22 at 1:10 PM, the Clinical Manager indicated the home visit for patient #6 on 12/05/22 was a comprehensive reassessment for recertification of home care services, the wound care wasn't performed every 2 days because they don't work weekends, she didn't coordinate with entity #12 to inform them the wounds were not changed every 2 days, and there was no coordination with Person #11 for recertification of home care services. When queried if coordination occurred with the physician for missed visits, the Clinical Manager indicated the EMR should automatically generate an order.

Coordinate referrals; CFR(s): 484.105(c)(3) Coordinating referrals, This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the Clinical Manager evaluated each patient referral to determine the appropriateness for home care. Findings include: 1. An agency policy with revised date February 2021, titled "Patient Admission Criteria", stated, "... When a telephone referral is received by the agency, a referral form is completed by a [sic] RN ... Each referral is evaluated by the Clinical Manager ... to determine the appropriateness of home care ...." 2. An agency job description signed by Employee #7 (Referral/Intake Supervisor/Office Manager) and the Administrator on 9/10/18, titled "Referral/Intake Supervisor", stated "... Responsible for managing all aspects of the patient intake process ... Essential Job Functions ... Ensures seamless transition of patients to home care by providing direct oversight of patient education and preparation of home care, plan of care initiation, and coordination of care with multiple service providers ... Position Qualifications ... 1. Registered Nurse with current licensure ... 2. Bachelor's degree in Nursing ...." The document evidenced the position qualifications "1. Registered Nurse with current licensure [and] 2. Bachelor's degree in Nursing" were crossed out and initialed by the Administrator. 3. During an interview on 12/05/22 at 3:00 PM, The Clinical Manager indicated she was not involved with referrals or the intake process, she never saw any paperwork about new referrals until after Employee #7 processed the paperwork, Employee #7 decided if the patients were accepted for care or not, Employee #7 did all the "leg work", Employee #7 told her (the Clinical Manager) when to admit the patient, and the patients were almost always admitted well after the referral dates. When queried if Employee #7 was an RN or licensed practical nurse (LPN), the Clinical Supervisor stated "... No ..." 4. During an interview on 12/06/22 at 11:25 AM, when queried to describe the referral/home care admission process, Employee #7 indicated when she received a referral, she decided if they (the agency) could accept it or not based on the service area and what type of insurance the patient had, and she would let the referring entity/person know if the agency could accept the patient or not; she (Employee #7) would verify the insurance, make sure the agency had all required paperwork, such as the history and physical (H&P), wound orders, or anything like that, and then after that, she entered the referral into the system (electronic medical record [EMR], notified the RN, called the patient, and set up a time to do the admission for home care services. 5. During an interview on 12/06/22 at 1:37 PM, the Administrator indicated they (agency) didn't need an RN to do the patient "intake part", they had a Clinical Manager that Employee #7 could consult if she needed anything, and Employee #7 processed all referrals. The Clinical Manager indicated she was made aware of patient referrals after everything was ready and insurance was cleared, Employee #7 would sent her the patient's information, and then she (the Clinical Manager) would call the patient to schedule the initial/admission visit. The Clinical Supervisor indicated she did not decide if patients were accepted for services, Employee #7 did. 6. During an interview on 12/09/22 at 12:12 PM, Employee #5 (Marketer) indicated Employee #7 was the Intake Coordinator, and Employee #6 (Office Staff) was starting to do that job as well. When queried who decided if a patient was accepted for care, Employee #5 indicated Employee #7 decided. When queried if either Employee #6 or #7 was a nurse, Employee #5 stated "No."

Assure patient needs are continually assessed CFR(s): 484.105(c)(4) Assuring that patient needs are continually assessed, and This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the Clinical Manager failed to ensure the patients' needs were assessed, for 2 of 2 home visits observed with a Registered Nurse (RN) (#2, 6). Findings include: 1. An agency job description received on 12/06/22, revised date February 2022, titled "Director of Clinical Services [Clinical Manager]", stated, "... Assures ongoing assessment of patient/family needs ...." 2. Clinical record review for Patient #2 was completed on 12/08/22 (start of care date 8/08/22). A document for certification period 10/07/22 - 12/05/22, titled "Home Health Certification and Plan of Care", evidenced the patient's primary diagnosis was diabetes; and additional diagnoses included chronic non-pressure ulcer to the right ankle, and unspecified systolic (congestive) heart failure (impairment of the left side of the heart). Skilled nursing orders included observation and evaluation (assessment) of the patient. A home visit was observed with Patient #2 and the Clinical Manager on 12/05/22 from 2:15 PM - 3:00 PM. The Clinical Manager indicated the patient had 1 wound on the right lateral (outside) ankle, to which she provided wound care/treatment. Observed the patient's left foot was swollen, dark red/purple in color (indicative of impaired circulation), had several small raised blisters on the 2nd toe, and 2 dark purple areas on the ball (bottom, where the toes attach to the foot) of the left foot, by the great and 5th toe joints. The Clinical Manager indicated the left foot was like that for the last couple of weeks. The Clinical Manager failed to assess for presence of pedal pulses (throbbing of arteries on the top of the foot, to assess blood flow), or perform a diabetic foot exam (assess if the patient had sensation, adequate blood flow, inspect between toes, assess for ingrown toenails). During an interview on 12/08/22 at 12:03 PM, the Clinical Manager indicated the home visit for patient #2 on 12/05/22, was a comprehensive reassessment for recertification of home care services. The Clinical Manager stated, "... No, I did not check the pedal pulses ... I checked them the first time I saw him ....", and indicated she did not assess the left foot blisters on the 2nd toe, or the 2 dark purple areas on the ball of the left foot. When queried if she performed a complete comprehensive reassessment on the patient during the home visit on 12/05/22, the Clinical Manager indicated she did not. 3. Clinical record review for Patient #6 was completed on 12/08/22 (start of care date 10/07/22). A document for certification period 10/07/22 - 12/05/22, titled "Home Health Certification and Plan of Care" evidenced diagnoses included chronic venous hypertension (a condition that results from weakened lower extremity veins that have lost their ability to return blood to the heart, which causes high blood pressure in the legs), and chronic non-pressure ulcers (wounds caused by insufficient blood flow, or poor circulation) to both lower legs. Skilled nursing orders included observation and evaluation of the patient, and measure wounds weekly (wound measurements are assessed and documented as length, then width, then depth). A home visit was observed with Patient #6 and the Clinical Manager on 12/05/22, from 11:00 AM - 12:05 PM. The Clinical Manager performed wound care to each lower extremity, measured the wound on the front of the left lower leg (length, 7.5 cm [centimeters], width 13.0 cm), and a wound on the inside of the left lower leg (2.0 cm x 2.0 cm). Both of the patient's lower legs were swollen. The Clinical Manager failed to measure the depth of either wound, or assess for presence of pedal pulses. During an interview on 12/08/22 at 1:10 PM, the Clinical Manager indicated the home visit for patient #6 on 12/05/22, was a comprehensive reassessment for recertification of home care services, and confirmed she didn't measure the depths of the wounds, or assess pedal pulses. When queried if she performed a complete comprehensive reassessment on the patient during the home visit on 12/05/22, the Clinical Manager indicated she did not, she couldn't do some of the assessments required during a comprehensive assessment/reassessment because she had a bad elbow, and she just asked the patients questions instead of actually assessing them. 4. During an interview on 12/09/22 at 2:00 PM, the Administrator indicated he expected the nurse to assess everything.

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 observation, record review, and interview, the Clinical Manager failed to ensure clinical services were provided in accordance with current clinical practice guidelines and accepted professional standards of practice, for 2 of 2 home visits observed (#2, 6). Findings include: 1. An agency policy with revised date February 2021, titled "Reassessments ....", stated, "... Staff will additionally reassess each patient with each home visit on an ongoing basis ...." 2. An agency job description received on 12/06/22, revised date February 2022, titled "Director of Clinical Services [Clinical Manager]", stated, "... Assures ongoing assessment of patient/family needs and implementation of ... plan of care ... fulfills job requirements ...." 3. Review on 12/5/22 of a National Library of Medicine web-based reference, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4144247/, cite: Nair B. Compression therapy for venous leg ulcers. Indian Dermatol Online J. 2014 Jul;5(3):378-82. doi: 10.4103/2229-5178.137822. PMID: 25165679; PMCID: PMC4144247, titled “Compression therapy for venous leg ulcers”, stated “... Bandages should generally be applied toe to knee at 50% stretch and with 50% overlap ....” 4. Clinical record review for Patient #2 was completed on 12/08/22 (start of care date 8/08/22). A document for certification period 10/07/22 - 12/05/22, titled "Home Health Certification and Plan of Care" evidenced the patient's primary diagnosis was diabetes, and an additional diagnosis of a chronic non-pressure ulcer to the right ankle, and unspecified systolic (congestive) heart failure (impairment of the left side of the heart); skilled nursing orders included to teach disease process and diet, provide wound care to the right ankle, and evaluate wound for healing. A home visit was observed with Patient #2 and the Clinical Manager on 12/05/22 from 2:15 PM - 3:00 PM. The Clinical Manager indicated the patient had 1 wound on the right lateral (outside) ankle, to which she provided wound care/treatment. Observed the patient's left foot was swollen, dark red/purple in color (indicative of impaired circulation), had several small raised blisters on the 2nd toe, and 2 dark purple areas on the ball (bottom, where the toes attach to the foot) of the left foot, by the great and 5th toe joints. The Clinical Manager indicated the left foot was like that for the last couple of weeks. The patient indicated he needed his toenails trimmed, and asked the Clinical Manager to trim them. The Clinical Manager indicated she couldn't trim them, but she'd have another agency nurse do it. The Clinical Manager failed to trim the patient's toenails per the patient's request. During an interview on 12/08/22 at 12:03 PM, when queried why she failed to trim the patient's toenails, the Clinical Manager indicated she made someone bleed before while cutting their toenails, so she won't do it anymore. When queried if she arranged to ensure the patient's toenails were trimmed, the Clinical Manager indicated she didn't. 5. Clinical record review for Patient #6 was completed on 12/08/22 (start of care date 10/07/22). A document for certification period 10/07/22 - 12/05/22, titled "Home Health Certification and Plan of Care" evidenced diagnoses included chronic venous hypertension (a condition that results from weakened lower extremity veins that have lost their ability to return blood to the heart, which causes high blood pressure in the legs), and chronic non-pressure ulcers (wounds caused by insufficient blood flow, or poor circulation) to both lower legs. A home visit was observed with Patient #6 and the Clinical Manager on 12/05/22, from 11:00 AM - 12:05 PM. The Clinical Supervisor performed wound care to each lower extremity. Both of the patient's lower legs were swollen. The Clinical Manager applied elastic compression wraps to each of the patient's lower legs, started each wrap from just below the knee and wrapped downward to the toes. The Clinical Manager failed to correctly apply the elastic compression bandages in accordance with accepted professional practices. During an interview on 12/08/22 at 1:10 PM, the Clinical Manager indicated she applied the patient's elastic compression bandages from the top to bottom of the leg/foot, and she didn't know they should be applied from the toes upward to below the knee, to prevent pooling of blood in the feet/toes. During an interview on 12/08/22 at 3:30 PM, the Clinical Manager indicated her personnel record failed to evidence a clinical competency document for the application of elastic compression bandages. During an interview on 12/09/22 at 2:00 PM, when queried to describe the correct application of elastic compression bandages to the lower legs, the alternate Clinical Manager stated, "... I usually start at the top and work my way down ... I haven’t done that very much ...."

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure the patient's clinical record contained the current comprehensive reassessment and updated/revised plan of care (Please see tag G1012); failed to ensure the clinical record evidenced the name/contact information for the patient's primary care physician/practitioner (Please see tag G1020); failed to ensure a transfer and/or discharge summary completed and sent to the appropriate physician/practitioner and/or or receiving facility (Please see tag G1022); failed to retain all patients' clinical records per State/Federal regulation (Please see tag G1026); and failed to ensure it safeguarded all patients' clinical record information against loss or unauthorized use (Please see tag G1028). This practice had the potential to affect all patients serviced by the agency. The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care for the Condition of Participation 42 CFR §484.110: Clinical Records. A standard level deficiency was cited as follows: Based on observation, record review, and interview, the Registered nurse (RN) failed to ensure all clinical records were documented accurately, and adhered to current clinical record documentation standards of practice, for 2 of 2 home visits observed with an RN (#2, 6), and 1 of 1 clinical record reviewed with no identified certifying physician (#1). (Tag G1008) Findings include: 1. An agency policy, revised date February 2022, titled "Medical Record Content", stated, "... The Agency will initiate and maintain an individual and accurate medical record for each patient ...." 2. An agency policy, revised date February 2022, titled "Professional Standards of Practice", stated, "... The Agency and staff will comply with accepted professional standards and principles ...." 3. An agency policy, revised date February 2022, titled "Plan of Care ... and Physician/Practitioner Orders", stated, "... Verbal orders are accepted only by personnel authorized to do so by applicable state laws and regulations ... put in writing, signed, timed, and dated with the date of receipt ...." 4. An agency document with effective date 2/01/2016, titled, "General Contract for Services", evidenced the home health agency contracted with Entity #8 to provide Quality Assurance/Compliance for preparations of Federal and State re-certification surveys; identify, correct, and help implementation process of deficiencies identified in Administrative/Clinical documentation and processes; and any plan of correction following surveys. The contract failed to evidence staff qualifications included current professional licensure to receive/alter physician orders, or other documents which required the author's credentials as a skilled licensed professional. 5. Clinical record review for Patient #1 was completed on 12/06/22. The electronic medical record (EMR) evidenced Person # 7 was the patient's certifying physician. A document dated 10/12/22, titled "Referred for Admission", stated, "... Order read back and verified with physician ....", was last updated by Person #21 (not a licensed skilled professional [RN or licensed practical nurse (LPN]), and failed to evidence the document was signed/authenticated by an RN. A document dated 10/12/22, titled "Admission Order ....", evidenced the document was a verbal order, which stated, "... Order read back and verified with physician ...." A document dated 10/14/22, titled "Transfer ....", evidenced the document was a verbal order, which stated, "... Order read back and verified with physician ...." The document failed to evidence the document was signed/authenticated, dated or timed by an RN. A document dated 10/14/22, titled "Resumption of Care ... 8:42 PM", evidenced the document was an incomplete verbal order, which stated, "... Order read back and verified with physician ...." The document failed to evidence the document was signed/authenticated, dated or timed by an RN. A document dated 11/28/22, titled "Discharge from Agency ....", evidenced the document was blank verbal order, which stated, "... Order read back and verified with physician ...." The document evidenced it was last updated by Employee #7, and failed to evidence the document was signed/authenticated, dated or timed by an RN. During an interview on 12/06/22 at 1:47 PM, the Administrator indicated Person #21 was a quality assurance person he contracted with (Entity #8) to provide assistance with clinical record compliance and accuracy, and this person was not a licensed skilled professional. During an interview on 12/08/22 at 12:12 PM, the Clinical Manager indicated people with administrative privileges in the EMR can create/alter/delete documents which also included orders, Person #21 was "Quality Assurance", and Employee #7 (Referral/Intake Supervisor) and Person #21 both had those privileges, neither of which was a licensed skilled professional. During an interview on 12/09/22 at 12:12 PM, Employee #5 (Marketer) indicated Employee #7 was not a nurse. During an interview on 12/06/22 at 1:47 PM - 3:10 PM, Employee #6 (Office staff) indicated Person #7 sent back all of the orders the agency sent to him for signature, and indicated he wasn't Patient #1's physician. When queried to submit the orders/documents received from Person #7, Employee #6 indicated she shredded them, and the agency did not know who the patient's physician was. When queried, the Administrator indicated the agency had no signed orders for this patient. When queried why the physician orders indicated a clinician “read back and verified” verbal orders, if the physician never gave the verbal orders, the Clinical Manager stated, "... Maybe we’re going by what the patient said ...." The clinical records were falsified to suggest Person #7 gave verbal orders to a licensed skilled professional. When queried why unlicensed skilled professionals created orders in the EMR, the Administrator declined to provide a response. When queried, Employee #7 (not a licensed skilled professional) indicated she created the discharge verbal order, (dated 11/28/22 at 10:14 AM, titled "Discharge from Agency"), but then recanted her statement and indicated it was a "communication note". 6. A home visit was observed with Patient #2 and the Clinical Manager on 12/05/22 from 2:15 PM - 3:00 PM. The Clinical Manager failed to provide any skilled teaching during the visit, assess pedal pulses (pulses on the tops of the feet to check blood flow), measure any wounds on the left foot/toes, or perform a comprehensive assessment. Clinical record review for Patient #2 was completed on 12/08/22. A document received 12/02/22 at 11:30 AM, dated 9/26/22 at 7:20 PM, titled, "Change Visit Frequency: 9/26/22 ... 7:20 PM" (a verbal order), stated, "... SN [skilled nurse] frequency changed ... new SN frequency ...." The document evidenced it was last updated by Person #21, and stated "... Order read back and verified with physician ...." The document failed to evidence a licensed skilled professional received or signed the order. An additional verbal order document received on 12/08/22, dated 9/26/22 at 7:20 PM, titled, "Change Visit Frequency: 9/26/22 ... 7:20 PM" (a verbal order), stated, "... SN to make a PRN [as needed] visit on 9/26/2022 ...." The document was signed/authenticated by the Clinical Manager, dated 9/26/2022. This document failed to be evidenced in the EMR on 12/02/22 at 11:30 AM. A document dated 12/05/22, titled "Skilled Nurse Visit", evidenced the Clinical Manager assessed the patient's pedal pulses, provided skilled teaching to the patient/caregiver, which included safety precautions, diabetic monitoring/care, dietary/nutrition requirements, infection control measures, prevention of pressure ulcers (wounds caused by prolonged/unrelieved pressure), proper hand washing techniques, and signs and symptoms of wound infection. The Clinical Manager was not observed providing any skilled teaching or assessment of the patient's pedal pulses during the home visit on 12/05/22. A document dated 12/05/22, titled "Wound Care Worksheet" evidenced the Clinical Manager measured a wound on the patient's left great toe. The Clinical Manager was not observed measuring a wound on the patient's left great toe during the home visit on 12/05/22. During an interview on 12/05/22 at 3:00 PM, the Clinical Manager indicated staff at Entity #8 frequently changed her clinical documents without her consent, and the Administrator was aware of her concern. During an interview on 12/08/22 at 12:03 PM, the Clinical Manager indicated the home visit observed on 12/05/22 with Patient #2 was a recertification visit (comprehensive reassessment). When queried if she performed a comprehensive reassessment on the patient, the Clinical Manager stated, "... No, but it auto-fills most of that anyways ...." When queried about the skilled nursing visit note dated 12/05/22, the Clinical Manager indicated the EMR notes flow over one visit to another (prefills documentation based on previous nursing visits), and stated "... no I did not check pedal pulses ... I checked them the first time I saw him ...." When queried why she documented skilled teaching was performed, the Clinical Manager stated, "... No ... I didn’t teach anything during the visit ... That is an automated thing ... I taught him in the past, so I just figured it was fine to leave it there ...." When queried why she documented measurements for the left toe, the Clinical Manager stated, "... That’s auto-filled as well ... but I can change it ... those are wound clinic measurements ...." During an interview on 12/08/22 at 12:12 PM, the Clinical Manager indicated someone must have deleted the original order dated 9/26/22 (with orders indicating a frequency change), she didn't delete it, unlicensed staff with administrative privileges could create/alter/delete documents,. and person #21 did quality assurance activities. 7. A home visit was observed with Patient #6 and the Clinical Manager on 12/05/22, from 11:00 AM - 12:05 PM. The patient was a black or African- American female. Observed the Clinical Manager measure a wound on the patient's left lower leg (7.5 centimeters [cm] in length, 13.0 cm in width). The depth of the wound was full thickness (through all layers of skin), and observed as greater than 0.1 cm. The Clinical Manager failed to measure the depth of the wound, assess pedal pulses, or provide any skilled teaching during the visit. Clinical record review for Patient #6 was completed on 12/08/22 (start of care date 10/07/22). A document dated 10/07/22, titled "Start of care ...." (a comprehensive assessment) indicated the patient's was a white male. A document for certification period 10/07/22 - 12/05/22, titled "Home Health Certification and Plan of Care" evidenced skilled nursing orders included to measure wounds weekly (wound measurements are recorded as length, by width, by depth [L x W x D]). A document dated 12/05/22, titled "Skilled Nurse Visit", evidenced the Clinical Manager assessed the patient's pedal pulses, and provided skilled teaching to the patient/caregiver, which included safety precautions, emergency preparedness, medications, dietary/nutrition requirements, infection control measures, prevention of pressure ulcers, proper hand washing techniques, and signs and symptoms of wound infection. The Clinical Manager was not observed providing any skilled teaching or assessment of the patient's pedal pulses during the home visit on 12/05/22. A document dated 12/05/22, titled "Wound Care Worksheet" evidenced the Clinical Manager inaccurately documented the wound on the patient's left lower leg as 13.0 cm x 7.5 cm x 0.1 cm (the observed measurement during the home visit on 12/05/22 was 7.5 cm x 13.0 cm, with no depth measured). During an interview on 12/08/22 at 1:10 PM, the Clinical Manager indicated the home visit observed on 12/05/22 with Patient #6 was a recertification visit (comprehensive reassessment). When queried if she performed a comprehensive reassessment on the patient, the Clinical Manager stated, "... No ...." When queried how the comprehensive assessment would be completed, including assessment of OASIS (Outcome and Assessment Information Set) data items, if no comprehensive assessment occurred, the Clinical Manager indicated the document would auto-fill, she didn't complete some of the components required during a comprehensive assessment because she had a bad elbow, and she just asked the patients instead of assessing them. When queried about the skilled nursing visit note dated 12/05/22, the Clinical Manager indicated she didn't assess the patient's pedal pulses, she didn't perform any skilled teaching, and stated "... like I said ... that auto-fills ...." When queried why she documented a depth measurement for the left lower extremity if she did not assess it, the Clinical Manager indicated it was auto-filled, indicated she was unaware wounds were documented as L x W x D, and confirmed they were documented inaccurately (W x L x D) on the "Wound Care Worksheet" (12/05/22). During an interview on 12/09/22 at 2:22 PM, the Administrator and alternate Clinical Manager confirmed the race/ethnicity on the patient's comprehensive assessment dated 10/07/22 was inaccurate. 8. During an interview on 12/09/22 at 2:00 PM, the Administrator indicated both nursing visits conducted with Patient #2 and Patient #6 were recertification visits (comprehensive reassessment visits), but the Clinical Manager completed routine visit notes ("Skilled Nurse Visit" and "Wound Care Worksheet") because she didn't have time to complete the comprehensive reassessment documents before she left town (evening of 12/08/22), and she would complete comprehensive reassessment documents for Patient #2 and Patient #6 when she returned to work on 12/12/22. The Administrator also indicated the EMR failed to evidence comprehensive reassessment visit notes dated 12/05/22, for Patient #2 or Patient #6.

Contact info for primary care practitioner CFR(s): 484.110(a)(5) Contact information for 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; and This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the clinical record evidenced the name/contact information for the patient's primary care physician/practitioner, for 1 of 8 clinical records reviewed (#1). Findings include: An agency policy with revised date February 2022, titled "Medical Record Content", stated, "... The Agency will provide an accurate and current medical record for every patient ... will contain the following ... Physician's/Practitioner's name and referral source ....” Clinical record review for Patient #1 was completed on 12/06/22 (Start of care date 10/12/22, discharge date 11/28/22), evidenced a document titled "Home Health Certification and Plan of Care" for certification period 10/12/22 - 12/10/22. The document indicated Person #7 was the patient's certifying physician. During an interview on 12/06/22, Employee #6 indicated all orders in the patient's record remained unsigned by Person #7. Person #7 informed the agency he was not the patient's physician, and the agency didn't know who the patient's physician was. When queried, Employee #6 indicated she hasn't contacted the patient to find out who the correct physician was, and when queried how long the agency knew the physician information was incorrect, Employee #6 stated, "... I'd say about November [2022] ...."

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure a transfer and/or discharge summary was completed and sent to the appropriate physician/practitioner and/or or receiving facility, for 4 of 4 records reviewed with patients who were transferred with inpatient admission and/or discharged from the agency (#1, 3, 5, 7). Findings include: 1. An agency policy with revised date February 2022, titled "Medical Record Content", stated, "... The Agency will provide an accurate and current medical record for every patient ... will contain the following ... A completed discharge summary when patient is discharged from the agency ...." 2. An agency policy with revised date February 2022, titled "Transfer/Referral Criteria and Planning", stated, "... When a patient's care needs change to require ... specialized services not provided by the agency, the Agency must inform ... the physician/practitioner who is responsible for the patient's home health plan of care ... Appropriate parties will be informed immediately ... This is accomplished by ... A written Transfer Summary ... will be completed ... will be provided ...." 3. Clinical record review for Patient #1 was completed on 12/06/22 (Start of care date 10/12/22, discharge date 11/28/22), and evidenced an undated, unsigned document titled "Transferred to an inpatient facility ....". The document indicated the patient was transferred on 10/14/22. The document failed to evidence the certifying physician was notified, and the electronic medical record (EMR) indicated the document was "In Progress". A document dated 10/18/22, titled “Home Discharge Instructions”, indicated the patient was hospitalized for emergent care at Entity #10 (a hospital) from 10/15/22 – 10/18/22, for seizures. A document dated 11/28/22, titled "... Discharge from agency", (a discharge comprehensive assessment) stated "... Status ... In Progress ...." The document failed to be completed, or signed and dated by a clinician. During an interview on 12/06/22 at 2:00 PM, the Clinical Manager indicated the last page of the discharge comprehensive assessment was the discharge summary, they didn’t always do a discharge assessment in person, as it depended on the nurse’s availability/schedule, and the discharge assessment wasn’t completed. When queried to describe the transfer to inpatient facility process, the Clinical Manager indicated they created transfer assessment document within 48 hours, the last page of the assessment was the transfer summary, and it had to be sent to the receiving facility. When queried, the Clinical Manager indicated the EMR did not evidence the transfer summary was sent to the hospital, and the Administrator indicated he would submit the requested information. Upon survey exit, nothing further was submitted for review. During an interview on 12/08/22 at 2:30 PM, the Clinical Manager indicated documents in the EMR marked as “in progress” meant they were not yet completed. 4. Clinical record review for Patient #3 was completed on 12/08/22 (start of care date 1/31/22). A document titled "Transferred to an inpatient facility ....", evidenced the patient was transferred to Entity #10 (a hospital) for evaluation. The EMR failed to evidence the certifying nurse practitioner was notified, or a summary was sent. A document received from Entity #1 (a hospital) on 12/02/22, dated 10/17/22, titled “Discharge Summary”, indicated the patient required emergent care, and was hospitalized from 10/10/22 – 10/17/22, due to a new infected wound, and osteomyelitis (inflammation of bone caused by infection). During an interview on 12/02/22 at 2:50 PM, Person #17 indicated the patient was hospitalized at Entity #1 (a hospital), not Entity #10 (a hospital). The EMR failed to evidence the correct emergent care facility the patient transferred to, or a summary was sent. During an interview on 12/08/22 at 2:30 PM, the Clinical Manager indicated the EMR didn't evidence the certifying practitioner was notified, or a summary was faxed to the hospital. 5. Clinical record review for Patient #5 was completed on 12/09/22 (start of care date 9/06/22, discharge date 11/04/22). A document dated 11/04/22, titled "... Discharge from agency", stated "... Status ... In Progress ...." The document was largely blank. The EMR failed to evidence a discharge summary. During an interview on 12/09/22 at 2:26 PM, the alternate Clinical Manager indicated the document titled "... Discharge from agency" was not completed, nor signed and dated by a clinician. The Administrator indicated the EMR didn't evidence the date or time the physician was notified or if a summary was sent, and they (the agency) needed to keep track of this. 6. Clinical record review for patient #7 was completed on 12/09/22 (start of care date 11/09/22). The EMR failed to evidence a discharge assessment (which included the discharge summary) was completed. A document dated 11/28/22, titled "Discharge from Agency ...." evidenced it was a physician order, the document was blank, and was not signed by a clinician or the physician. During an interview on 12/09/22 at 2:30 PM, Employee #6 indicated the plan of care and other orders weren't completed or signed by the clinician or physician. The alternate Clinical Manager indicated the EMR did not include a discharge assessment, and would expect the nurse to conduct a discharge assessment.

Retention of records CFR(s): 484.110(c)(1)(2) Standard: Retention of records. (1) Clinical records must be retained for 5 years after the discharge of the patient, unless state law stipulates a longer period of time. (2) The HHA's policies must provide for retention of clinical records even if it discontinues operation. When an HHA discontinues operation, it must inform the state agency where clinical records will be maintained. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to retain all patients' clinical records per State/Federal regulation, for 10 of 10 random patients sampled without clinical record review (#10, 11, 12, 13, 14, 15, 16, 17, 18, 19), and per the agency's own admission, 1 of 1 active patient records reviewed with missing clinical record documents (#4). Findings include: 1. Indiana Code (IC) 16-39-7-1 stated, "... Maintenance of health records by providers ... "provider" means the following ... (12) A home health agency licensed under IC 16-27 ... (b) A provider shall maintain the original health records or microfilms of the records for at least seven (7) years ...." 2. An agency policy with revised date February 2022, titled "Medical Record Content", stated, "... The Agency will ... maintain an individual and accurate medical record for each patient ... in compliance with all federal/state laws and regulations ...." 3. An agency policy with revised date October 2017, titled "Medical Record Retention", stated, "... patient medical records are retained minimally for five (5) years after the discharge of the patient, unless state law stipulates a longer period of time ...." 4.. During an interview on 11/30/22 at 11:15 AM, the Clinical Supervisor indicated the home health agency was required to store medical records for 7 years. 5. On 12/09/22 at 1:01 PM, the home health agency's "On-Call Log" was submitted for review. Dates reviewed were 2/06/21 to present, with the newest entry dated 7/10/21. Patients #10, 11, 12, 13, 14, 15, 16, 17, 18, and 19 were documented by name with concerns, but clinical records for patients #10-19 were not evidenced in the agency's electronic medical record (EMR) software. 6. During an interview on 12/06/22 at 1:09 PM, Person #7 (Referral/Intake Supervisor) submitted referral information for Patient #4 (an active patient), and indicated the dates would be wrong, because when they switched from Entity #5 (previous EMR software provider) to Entity #6 (current EMR software provider) within about a year ago, they had to enter Patient #4 as a new admit, and had no older clinical records for Patient #4. Patient #4's referral documents submitted on 12/06/22 evidenced a physician order dated 10/28/21, for home health nursing services. 7. Clinical record review for Patient #4 was completed on 12/09/22. A document dated 1/26/22, titled "Home Health Certification and Plan of Care" evidenced the patient's start of care date was 1/26/22. The EMR failed to include any clinical records prior to 1/26/22. 8. During an interview on 12/06/22 at 1:09 PM, when queried if the agency had access to clinical records stored within Entity #5's software, the Administrator indicated the agency did not, and could only get access to the medical records if he paid additional money. 9. During an interview on 12/09/22 at 2:51 PM, when queried why Patients' #10, 11, 12, 13, 14, 15, 16, 17, 18, and 19's clinical records weren't evidenced in the home health agency's current EMR software, the Administrator indicated he had no access to those medical records, as they were from the previous EMR company.

Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure it safeguarded all patients' clinical record information against loss or unauthorized use. Findings include: An agency policy with revised date March 2018, titled "Patient Confidentiality", stated, "... Home care records will not be left in unattended areas in the office, e.g., the reception area. All home care records will be kept stored in metal file cabinets to minimize the possibility of damage from fire and water. Charts will be protected against unauthorized corruption, damage, and/or intrusion ... all home care records will be maintained in metal locked filing cabinets or locked file room ...." On 11/30/22, 12/01, 12/05, 12/06, 12/07, 12/08, and 12/09 (2022), observed 3 bankers boxes stacked on the floor next to the wall in the main reception area of the home health agency. The boxes were not secured in locked cabinets. On 12/09/22 at 2:50 PM, when queried of the 3 bankers boxes contents, the Administrator lifted the lid of the topmost box. The box contained file folders with patient names and clinical documents. The Administrator indicated all 3 boxes contained old patient discharged records, and he needed to put them away.