Every finding on record at Pathways Healthcare LLC

Based on the findings of an unannounced, onsite Medicare recertification survey conducted January 25 through January 27, 2023, Erwine Home Health and Hospice, Inc. was found to be in compliance with the requirements of 42 CFR, Part 484.22, Subpart B, Conditions of Participation: Home Health Agencies - Emergency Preparedness.

Based on the findings of an unannounced, onsite Medicare recertification survey conducted January 25 through January 27, 2023, Erwine Home Health and Hospice, Inc. was found not to be in compliance with the following requirements of 42 CFR, Part 484, Subparts B and C, Conditions of Participation: Home Health Agencies.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on the review of agency policies/procedures, documentation and clinical records, and based on interview with the registered nurse/alternate clinical manager (RN/Alt. CM-Employee #7) and the administrator, the agency failed to ensure that agency staff notified the primary care physician/provider (PCP) of a change in patient condition for two (2) of two (2) patients who required hospitalization during the home health certification period. (Patients #5 and #9) Findings include: On January 27, 2023 at approximately 3:05 PM, review of agency "Registered Nurse (RN)" job description revealed the following under "Communication": Prepares clinical notes and updates the primary physician when necessary... On January 27, 2023 at approximately 3:10 PM, review of the agency policy titled "Description of Services, Skilled Professional Services" revealed the following under "Procedures": 5. Skilled professionals must assume responsibilities for, but not restricted to...f. Communicating with all physicians involved in the Plan of Care... On January 27, 2023 at approximately 2:58 PM, review of the agency policy titled "Coordination of Services/Patient Care" revealed the following: Policy: Coordination of patients' care between...primary care...will occur. The goal is to promote cooperative care planning assuring continuity of care. Procedure: 5. Staff members are expected to maintain and document regular communication... -Any staff member receiving information about...re-hospitalization, or another occurrence, is expected to notify...the physician(s) as appropriate... Patient #5: Between January 26, 2023 at approximately 3:31 PM and January 27, 2023 at approximately 2:36 PM, review of the clinical record revealed the start of care date was 12/04/2022, the diagnoses include acute respiratory failure, tracheostomy status (surgically created area located in the front of the neck) and paraplegia (paralysis below the waist), that skilled nursing (SN) is to change the Foley (urinary) catheter every three (3) to four (4) weeks, and that long-term nursing goals included for the physician to be updated/contacted with any changes in patient status as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 12/04/2022 through 02/01/2023. Review of the “Start of Care Comprehensive Assessment” dated 12/04/2022 revealed the Foley catheter was in place, that the Foley was draining clear yellow urine and that the patient's family member managed and changed the Foley monthly. Review of the routine "Skilled Nursing Visit Assessment" note dated 12/17/2022 revealed the RN/Alt CM (Employee #7) documented that patient required treatment at the emergency room (ER) on 12/15/2022 due to "red blood in Foley bag" and that the Foley was changed and flushed during the ER visit. Employee #7 documented that the Foley output on 12/17/2022 still exhibited hematuria (blood in urine) but that the family member reported that the hematuria had improved. Review of transfer assessment documentation dated 01/03/2023 revealed the patient was transferred to the ER for unknown reasons. Resumption of care (ROC) order documentation revealed the patient was hospitalized from 12/31/2022 through 01/12/2023. Review of ROC SN visit documentation dated 01/12/2023 revealed the patient inpatient diagnosis included urinary tract infection and bladder rupture. There was no documentation on the "Skilled Nursing Visit Assessment" noted dated 12/17/2022 which provided evidence that the RN/Alt. CM (Employee #7) notified the PCP that the patient required treatment at the ER on 12/15/2022 and that the Foley output continued to exhibit hematuria. During interview conducted on January 27, 2023 at 2:35 PM, the RN/Alt. CM (Employee #7) reported that the patient's family member may have called the PCP during the 12/17/2022 SN visit but Employee #7 confirmed there was no documentation in the clinical record which provided evidence that the aforementioned notification was completed. Employee #7 confirmed that Employee #7 did not notify PCP of the ER visit on 12/15/2022 nor of the Foley assessment findings on 12/17/2022. Patient #9 (Discharge): On January 27, 2023 at approximately 12:10 PM, review of the clinical record revealed the start of care date was 06/17/2022, the diagnoses included osteomyelitis (bone infection), that intravenous antibiotic therapy included ceftriaxone, that medication allergies included ceftriaxone and that SN goals included for the physician to be updated/contacted with any changes in patient status as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 06/17/2022 through 08/15/2022. Review of transfer assessment documentation dated 06/20/2022 revealed the patient was transferred to the ER due to improper medication administration/medication side effects. Review of ROC order documentation dated 06/25/2022 revealed the patient was hospitalized from 06/20/2022 through 06/24/2022 due to an allergic reaction to medication. There was no documentation in the clinical record which provided evidence that the PCP was notified on 06/20/2022 that the patient required ER treatment for a medication related reaction. During interview conducted on January 27, 2023 at approximately 3:30 PM, the administrator confirmed there was no documentation in the clinical records which provided evidence that agency staff notified the PCP's of the aforementioned condition changes for the above identified patients.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on the review of agency policies/procedures, documentation, personnel files and clinical records, and based on interview with the administrator, the governing body failed to ensure one (1) of one (1) skilled nursing (SN) services related complaint was investigated prior to January 25, 2023. (Patient #7) Findings include: On January 27, 2023 at approximately 10:12 AM, review of the agency policy titled "Grievance Process-Employee" revealed the following: Policy: Erwine Home Health and Hospice assures that the staff member has access to a process to investigate a staff member complaint. Between January 25, 2023 at approximately 12:27 PM and January 27, 2023 at approximately 9:40 AM, review of personnel file documentation revealed the following: -Employee #5: The date of hire of the RN/CM was 04/21/2008. Patient #7 (Discharge): On January 27, 2023 at approximately 7:30 AM, review of the clinical record revealed total parenteral nutrition (TPN-intravenous nutrition/feeding) was to be administered for 14 hours daily and that skilled nursing (SN) goals included for the patient to be independent with the administration of TPN as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 11/30/2021 through 01/28/2022. Review of the "Start of Care Comprehensive Assessment" dated 11/30/2021 revealed TPN administration orders and TPN bag placement findings were included under the SN assessment findings documented by Employee #5 under the "Narrative" section. On January 25 2023 at approximately 10:10 AM review of an employee complaint report dated 12/02/2021 revealed a complaint was submitted to the agency which alleged that the RN/CM (Employee #5) had failed to provide TPN administration education on 11/30/2021 which resulted in the TPN being improperly connected when assessed during the SN visit conducted on 12/01/2021. On January 23 2023 between the approximate times of 10:33 AM and 10:57 AM, review of the 2022 Governing Body (February, May, August and November) and the 2022 Quality Improvement/Professional Advisory Committee (February, June, August and November) meeting minutes failed to reveal that the above listed complaint allegation had been investigated by the agency. During interview conducted on January 27, 2023 at approximately 3:30 PM, the administrator confirmed there was no documentation which provided evidence that the above referenced complaint allegation had been investigated by the agency prior to January 25, 2023.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on the review of agency policies/procedures, documentation and clinical records, and based on interview with two (2) registered nurses (Employee #5-RN/Clinical Manager and Employee #7-RN/Alternate Clinical Manager) and the administrator, the agency failed to ensure external peripherally inserted central catheter (PICC-intravenous) line length and corresponding arm circumference was measured with each skilled nursing (SN) visit for two (2) of two (2) patients for whom PICC line assessment orders were provided by the primary care physician/provider. (Patients #5 and #9) Findings include: On January 27, 2023 at approximately 3:05 PM, review of agency "Registered Nurse (RN)" job description revealed the following under "Essential Job Functions/Responsibilities": 2. Regularly re-evaluates patient nursing needs... 6. Initiates appropriate preventative...nursing procedures... On January 27, 2023 at approximately 3:10 PM, review of the agency policy titled "Description of Services, Skilled Professional Services" revealed the following under "Procedures": 5. Skilled professionals must assume responsibilities for, but not restricted to...a. Ongoing interdisciplinary assessment of the patient... During interview conducted on January 27, 2023 at approximately 3:27 PM, the RN/Clinical Manager (RN/CM-Employee #5) confirmed that PICC line external length and corresponding arm circumference is to be measured during each skilled nursing (SN) visit. Patient #5: Between January 26, 2023 at approximately 3:31 PM and January 27, 2023 at approximately 2:36 PM, review of the clinical record revealed SN was to perform/provide the following as documented on the resumption of care (ROC) "Physician Order" dated 01/12/2023: -Assess PICC line... -Measure arm circumference every SN visit; and -Document amount of PICC line that is visible (external length) from insertion site every SN visit. There was no documentation in the clinical record which provided evidence that the RN/CM (Employee #5) measured the external length of the right upper extremity (RUE-arm) PICC line during the ROC SN visit performed on 01/12/2023. Patient #9 (Discharge): On January 27, 2023 at approximately 12:10 PM, review of the clinical record revealed SN was to perform/provide the following as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 06/17/2022 through 08/15/2022: -Assess PICC line... -Measure arm circumference every SN visit; and -Document amount of PICC line that is visible (external length) from insertion site every SN visit. There was no documentation in the clinical record which provided evidence that the following registered nurses (RN) measured the external length of the RUE PICC line, nor the corresponding arm circumference, during the below listed SN visits: -Employee #7 (RN/Alternate CM): 06/18/2022 routine SN visit; -Employee #9 (RN): 06/25/2022 ROC SN visit. There was no documentation in the clinical record which provided evidence that the RN (Employee #9) measured the external length of the RUE PICC line during the routine SNV performed on 06/18/2022. During interview conducted on 01/27/2023 at approximately 2:35 PM, the RN/Alternate CM (Employee #7) confirmed that measurement of the external length of the PICC line and corresponding arm circumference may not have been obtained at every SN visit. During interview conducted on January 27, 2023 at approximately 3:30 PM, the administrator confirmed there was no documentation in the clinical records which provided evidence that measurement of the external length of the PICC line and corresponding arm circumference had been obtained on the above referenced dates for the above identified patients.

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on the review of agency policies/procedures, professional guidance, clinical records and personnel files and based on interview with the administrator, the agency failed to ensure the two (2) of two (2) registered nurses (RN) completed a hands-on skills tracheostomy (surgically created airway located in the front of the neck) care demonstration/skills evaluation tracheotomy prior to the assignment to provide SN services to a patient for whom SN was to assess the tracheostomy site and provide instruction regarding tracheostomy care. (Employees #5 and #7) Findings include: On January 27, 2023 at approximately 3:15 PM, review of the agency policy titled "Orientation Plan" revealed the following: Policy...The Administrator and/or Director of Patient Services/Clinical Manager ensure all staff have received training and/or education and can competently perform the required client/patient services/care prior to being assigned to work independently. Procedure... 3. The following orientation items must occur before staff provides care, treatment and services without another team member...k. Additional training for special populations...specialized care... 5. Prior to patient contact...professional competencies are conducted and staff members are only assigned duties for which they have been deemed competent. On January 26, 2023 at approximately 4:48 PM, review of the Tracheostomy Care Group competency evaluation document titled "Competency Document to Support the Care of the Patent with a Tracheostomy or Laryngectomy" (surgical removal of the voice box) revealed the following: The practitioner will be able to fully demonstrate the knowledge and skills required for becoming a safe and effective practitioner in the care of a patient with a tracheostomy or laryngectomy....The tracheostomy care competency is considered a specialty competency... -Discuss and demonstrate the care of the stoma including appropriate dressings and tapes... Patient #5: Between January 26, 2023 at approximately 3:31 PM and January 27, 2023 at approximately 2:36 PM, review of the clinical record revealed the start of care date was 12/04/2022, the diagnoses include acute respiratory failure, tracheostomy status and paraplegia (paralysis below the waist), that skilled nursing (SN) is to perform the following as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 12/04/2022 through 02/01/2023: -Assess tracheostomy site for signs/symptoms of infection and complications and instruct patient/caregiver in tracheostomy care. Review of SN visit documentation revealed the RN/Clinical Manager (RN/CM-Employee #5) provided SN services on 01/12/2023 (resumption of care) and the RN/Alternate CM (Employee #7) provided SN services in December and January 2023. Between January 25, 2023 at approximately 12:27 PM and January 27, 2023 at approximately 9:40 AM, review of personnel file documentation revealed the following: -Employee #5: The date of hire of the RN/CM was 04/21/2008. Review of the "Initial Competency Assessment Skills Checklist-Registered Nurse", which was completed on 05/05/2008, revealed the method utilized to determine competency to provide tracheostomy care was via a review of policies/procedures. -Employee #7: The date of hire of the RN/Alt. CM was 05/07/2013. Review of the "Initial Competency Assessment Skills Checklist-Registered Nurse", which was completed on 05/09/2013, failed to reveal that the nursing preceptor had included documentation of the method utilized to determine competency to provide tracheostomy care. There was no documentation in the personnel files which provided evidence that Employee #5 and Employee #7 had completed a hands-on skills tracheostomy care demonstration/skills evaluation prior to the assignment to provide SN services to a patient for whom SN was to assess the tracheostomy site and provide instruction regarding tracheostomy care. During interview conducted on January 27, 2023 at approximately 3:30 PM, the administrator confirmed there was no documentation in the personnel files which provided evidence that the above referenced RN"s had completed a hands-on skills tracheostomy care demonstration/skills evaluation prior to the assignment to provide SN services to a patient for whom SN was to assess the tracheostomy site and provide instruction regarding tracheostomy care.

Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This ELEMENT is not met as evidenced by: Based on the review of agency policies/procedures and clinical records, observation, and based on interview with the responsible party of patient #1, the registered nurse/alternate clinical manager (RN/Alt. CM-Employee #7) and the administrator, the agency failed to ensure skilled nursing (SN) treatment orders included on the "Home Health Certification and Plan of Care" were consistent with observation or SN assessment findings for two (2) of nine (9) patients. (Patients #1 and #7) Findings include: On January 27, 2023 at approximately 3:08 PM, review of the agency policy titled "Contents of the Clinical Record" revealed the following under "Procedure": 4. Documentation...should be...factual... Patient #1: During home visit conducted on January 26, 2023 at approximately 9:00 AM, observation of patient care revealed the RN/Alt. CM (Employee #7) assessed and provided wound care to the left fourth (ring) finger. Between January 25, 2023 at approximately 1:04 PM and January 27, 2023 at approximately 10:32 AM, review of the clinical record revealed SN is to assess and provide wound care to the left index (second) finger as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 01/15/2023 through 03/15/2023. During telephone interview conducted on 01/27/2023 at approximately 10:28 AM, the patient's responsible party reported that agency staff has only provided wound care to the left fourth finger. The responsible party confirmed that a wound was never present on the left index finger. During interview conducted on January 27, 2023 at approximately 2:35 PM, the RN/Alt. CM (Employee #7) confirmed the wound was located on the left fourth finger and that the "Home Health Certification and Plan of Care" included the incorrect location which required wound assessment and wound care. Patient #7 (Discharge): On January 27, 2023 at approximately 7:30 AM, review of the clinical record revealed a double-lumen (2 ports) central venous catheter (CVC-intravenous) was inserted into the right upper chest as documented by the RN/CM (Employee #5) on the "Start of Care Comprehensive Assessment" dated 11/30/2021. Review of the "Home Health Certification and Plan of Care" for the initial certification period of 11/30/2021 through 01/28/2022 revealed the RN/CM (Employee #5) obtained orders to assess and provide site care to a peripherally inserted central catheter (PICC-intravenous line which is inserted to a vein in the arm) instead of the double-lumen CVC. During interview conducted on January 27, 2023 at approximately 3:30 PM, the administrator confirmed there was no documentation in the clinical records which provided evidence that the "Home Health Certification and Plan of Care" included treatment orders which were consistent with the aforementioned observation and SN assessment findings for the above identified patients.