Every finding on record at Maylath Valley Health Systems, Inc.

Based on the findings of an unannounced, onsite Medicare recertification survey conducted July 10 through July 14, 2023, Maylath Valley Health Systems, 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 July 10 through July 14, 2023, Maylath Valley Health Systems, 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.

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 review of agency policies/procedures and clinical records, observation and based on interview with a registered nurse (Employee #1), the Administrator (Employee #10) and the Nursing Supervisor/Clinical Manager (Employee #11), the agency failed to ensure medications and treatments were administered per physician orders for three (3) of nine (9) patients for whom skilled nursing (SN) staff administered medications and/or performed treatments. (Patients #5, #7 and #8) Findings include: On July 14, 2023 at approximately 3:30 PM, review of the agency policy titled "Patient's Plan of Care" revealed the following: Procedure...2. Drugs, services and treatments are administered as ordered by the physician. On July 14, 2023 at approximately 3:30 PM, review of the agency policy titled "Pharmaceutical Services" revealed the following: Procedure...2. Drugs are only administered as ordered by the physician. On July 14, 2023 at approximately 3:25 PM, review of the agency policy titled "Hickman Care and Maintenance" revealed the following: Policy: All Hickman care and service will be provided to the patient in accordance with physician order... Patient #5: Between July 13, 2023 at approximately 9:32 AM and July 14, 2023 at approximately 9:22 AM, review of the clinical record revealed pinpoint areas (wounds) were present on the right lower extremity (leg-RLE), that SN provided wound care and that SN was required to monitor open areas of the RLE as documented on the "Plan of Care" for the initial certification period of 05/27/2023 through 07/25/2023. Review of the interim physician order (PVC-8) dated 06/09/2023 revealed wound care to be provided to the RLE wounds included the application of Aquacel AG (wound treatment which includes a silver component). Review of "Visit Details" documentation revealed the LPN (Employee (EMP) #2) applied Aquacel (wound treatment which does not include a sliver component) to the RLE wounds on 06/26, 06/28 and 06/29/2023. There was no documentation in the clinical record which provided evidence the LPN (EMP #2) provided wound care in accordance with the 06/09/2023 physician order on 06/26, 06/28 and 06/29/2023. Patient #7: Between Jully 13, 2023 at approximately 12:45 PM and July 14, 2023 at approximately 9:35 AM, review of the clinical record revealed SN was to administer/perform the following as documented on the "Plan of Care" for the initial certification period of 05/25/203 through 07/23/2023: -Intravenous (IV) line dressing and cap changes weekly. -Flush IV line with 10 milliliters (ml) of normal saline (NSS) followed by heparin 5 ml (100 units per ml) weekly. During home visit conducted on 07/12/2023 at approximately 10:50 AM, the RN (EMP #1) changed the right chest IV/central venous catheter (CVC) dressing. During interview conducted during the home visit, the RN reported CVC cap changes and flushes are to be performed weekly. The RN failed to complete a CVC cap change and CVC flush during the 07/12/2023 SN visit. There was no documentation on the "Visit Details" notes which provided evidence the RN's (EMP #1 and #10) completed CVC cap changes during the weekly CVC dressing changes performed between 05/31/2023 and 07/12/2023. Review of "Visit Details" documentation revealed the RN (Employee #10) failed to flush the CVC with 5 ml of Heparin on 06/07, 06/14, 06/12 and 06/28/2023. Review of "Visit Details" documentation revealed the RN (Employee #1) failed to flush the CVC with 10 ml of NSS and 5 ml of Heparin on 07/05 and 07/12/2023. Patient #8: On July 14, 2023 at approximately 9:50 AM, review of the clinical record revealed SN was to provide the following wound care to the blistered areas of the RLE as documented on the interim physician order (PVC-12) dated 06/17/2023: -Apply skin prep and keep open to air. Review of "Visit Details" documentation revealed the RN (Employee #19) documented blisters were present on the RLE during the SN visit conducted on 07/06/2023 but there was no documentation which provided evidence the RN applied skip prep to the blistered areas of the RLE on 07/06/2023. During interview conducted on July 14, 2023 at approximately 3:45 PM, the Administrator and Nursing Supervisor/Clinical Manager confirmed drugs and treatments were not administered/completed as per physician orders for the above referenced patients.

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 review of agency policies/procedures and clinical records and based on interview with the Administrator (Employee #10) and the Nursing Supervisor/Clinical Manager (Employee #11), the agency failed to ensure skilled nursing (SN) staff notified the physician of SN assessment findings for two (2) of five (5) patients for whom a change in condition was documented in the clinical record. (Patients #1 and #15) Findings include: On July 14, 2023 at approximately 3:32 PM, review of the agency policy titled "Medical Management" revealed the following: Policy...4. When changes in the patient's condition, response to treatment, or other significant change affecting patient care is identified, the physician is notified and appropriate orders for changes in the plan of care are obtained. Patient #1 (Discharge): Between July 10, 2023 at approximately 12:37 PM and July 11, 2023 at approximately 12:49 PM, review of the clinical record revealed the start of care date was 12/19/2022, the primary diagnosis was type 2 diabetes mellitus (adult onset diabetes) with ketoacidosis (condition which can lead to diabetic coma or death) without coma and that SN services were required to monitor blood sugar (BS) levels and for signs/symptoms of hypoglycemia (low blood sugar)/hyperglycemia (high blood sugar) as documented on the "Plan of Care" for the initial certification period of 12/19/2022 through 02/16/2023. Transfer assessment documentation revealed the patient was re-hospitalized on 12/21/2023 due to blood sugar being out of control. Review of resumption of care "Visit Details" documentation dated 12/23/2023 revealed the patient was hospitalized due to hyperglycemia. Review of "Visit Detail" documentation dated 12/27/2022 and 01/02, 01/05, 01/16 and 02/07/2023 failed to reveal the registered nurse (RN-Employees #10), nor the licensed practical nurses (LPN-Employees #9 , #18 and #20-Former EMP), had notified the physician the patient was unable to perform BS monitoring due to the continuous blood glucose monitor (Dexcom) having been removed at the hospital, because the Dexcom had malfunctioned or because the blood glucose meter strips were expired or not available. "Visit Detail" note documentation revealed the blood sugar reading was approximately 400 on 01/27/2023 and approximately 300 on 01/31/2023. Review of "Visit Detail" note documentation revealed the patient's BS reading increased to 545 on 02/02/2023. Review of transfer assessment documentation dated 02/10/2023 revealed the patient was hospitalized due to blood sugar out of control. There was no documentation in the clinical record which provided evidence the LPN (EMP #9) notified the physician of the increase in the BS reading on 02/02/2023. Patient #15 (Discharge): On July 14, 2023 at approximately 1:40 PM, review of the clinical record revealed the primary diagnosis was acute respiratory failure with hypoxia (low oxygen level) and that SN was to monitor pulmonary (breathing) status as documented on the "Plan of Care" for the initial certification period of 01/16/2023 through 03/16/2023. Review of the start of care "Visit Detail" note dated 0/16/2023 revealed the respiratory rate was 18 breaths per minute (BPM) and the pulse oximetry (SPO2) reading (device which monitors blood oxygen levels) was 97%. Review of "Visit Details" documentation dated 01/26/2023 revealed the LPN (EMP #9) documented the patient's SPO2 reading decreased to 88%, the patient required a nebulizer (breathing) treatment which resulted in the SP02 improving to 94% and that the patient refused emergency room (ER) evaluation. Review of the "Visit Details" note for the second SN visit performed on 01/26/2023 revealed a second LPN (Employee #20-Former Employee) documented the respiratory rate was 36-40 BPM, skin condition was pale, lip color was blue, that the patient required a second nebulizer treatment and that the patient continued to refuse ER treatment. Review of transfer assessment documentation dated 01/27/2023 revealed the patient was hospitalized due to other respiratory problem. There was no documentation in the clinical record which provided evidence the physician was notified of the above listed respiratory status assessment findings on 01/26/2023. During interview conducted on July 14, 2023 at approximately 3:45 PM, the Administrator and Nursing Supervisor/Clinical Manager confirmed the physician was not notified of the above listed assessment findings for the above referenced patients.

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 review of agency policies/procedures and clinical records; observation and based on interview with the Administrator (Employee #10) and the Nursing Supervisor/Clinical Manager (Employee #11), the agency failed to ensure initial and ongoing skilled nursing (SN) assessments were completed as per agency policy/procedure and/or physician order for seven (7) of fifteen (15) patients for whom SN services were provided during the certification period. (Patients #1, #2. #5, #6, #7, #14 and #16) Findings include: On July 14, 2023 at approximately 3:30 PM, review of the agency policy titled "Patient's Plan of Care" revealed the following: Procedure...1. The written Plan of Care is based on initial and ongoing individualized patient assessment from admission through discharge.... On July 14, 2023 at approximately 3:34 PM, review of the agency policy titled "Patient Comprehensive Assessment" revealed the following: Procedure....2....Comprehensive assessment will include the following: i. System review, including....integumentary status.... On July 14, 2023 at approximately 3:25 PM, review of the agency policy titled "Hickman Care and Maintenance" revealed the following: Policy: All Hickman care and service will be provided to the patient in accordance with physician order... Patient #1 (Discharge); Between July 10, 2023 at approximately 12:37 PM and July 11, 2023 at approximately 12:49 PM, review of the clinical record revealed the primary diagnosis was type 2 diabetes mellitus (adult onset diabetes) with ketoacidosis (condition which can lead to diabetic coma or death) without coma and that SN services were required to monitor blood sugar (BS) and for signs/symptoms of hypoglycemia (low blood sugar)/hyperglycemia (high blood sugar) as documented on the "Plan of Care" for the initial certification period of 12/19/2022 through 02/16/2023. Review of SN "Visit Details" documentation failed to reveal the registered nurse (RN-Employee #1) assessed the patient's BS, nor the patient's ability to perform BS testing, during the start of care visit conducted on 12/19/2022 nor during the resumption care visit conducted on 12/23/2022. Patient #2: Between July 11, 2023 at approximately 1:15 PM and July 14, 2023 at approximately 9:42 AM, review of the clinical record revealed SN is to provide wound care to and assess the right great toe stasis ulcer (wound caused by circulatory problems), that SN goals include for the wound to remain free of sign/symptoms of infection and that the discharge plan includes for the open wound of the right great toe to heal without complications as documented on the "Plan of Care" for the initial certification period of 06/21/2023 through 08/19/2023. Review of SN "Visit Details" documentation failed to reveal the RN (Employee #13) assessed the right great toe wound size (length by width by depth) during the start of care visit conducted on 06/21/2023. Review of SN "Visit Details" documentation revealed drainage noted from the right toe wound varied from a scant (minimal) to a moderate amount during the SN visits conducted on 06/24, 06/28, 06/30, 07/02, 07/04, 07/06, 07/08 07/09 and 07/10/2023 but there was no documentation in the clinical record which provided evidence the licensed practical nurse (LPN-Employee #4) assessed the right great toe wound for the presence of drainage on 06/26/2023 and 06/27/2023 when wound care was performed by the LPN. Patient #5: Between July 13, 2023 at approximately 9:32 AM and July 14, 2023 at approximately 9:22 AM, review of the clinical record revealed drainage was noted from the pinpoint areas (wounds) of the right lower extremity (leg-RLE), that SN provided wound care to and that SN was required to monitor open areas of the RLE as documented on the "Plan of Care" for the initial certification period of 05/27/2023 through 07/25/2023. Review of SN "Visit Details" documentation revealed a moderate amount of drainage was noted from the RLE wounds on 06/13, 06/15 and 06/19/2023. There was no documentation which provided evidence the following LPN's assessed the RLE wound for the presence of drainage during the below referenced SN visits when wound care was performed by the LPN: Employee #2: 06/29/2023: Employee #4: 06/20, 06/22, 06/23, 06/27, 07/01 and 07/10/2023; Employee #14: 06/14 and 06/21/2023: Employee #15: 06/24/2023; Employee #16: 07/02/2023; and Employee #17: 06/25/2023. Patient #6: On July 13, 2023 at approximately 12:07 PM, review of the clinical record revealed the primary diagnosis is pressure ulcer of other site-stage 4 (wound caused by pressure which can extended to the muscle or bone), that SN is to provide wound care to the left foot wound, that SN goals include for the wound to be free of signs/symptoms of infection and that rehabilitation potential includes for the skin integrity impairment (wound) to decrease in size or heal prior to discharge as documented on the "Plan of Care" for the recertification period of 05/22/2023 through 07/20/2023. Review of SN "Visit Details" documentation revealed an open, draining wound of the left foot was present during the SN recertification visit conducted on 05/19/2023. There was no documentation in the clinical record which provided evidence the following LPN's assessed the left foot wound for the presence of drainage during the below referenced SN visits when wound care was performed by the LPN: Employee #4: 05/26, 06/02 and 06/09/2023; Employee #14: 06/05 and 06/07/2023; and Employee #17: 05/24/2023. There was no documentation in the clinical record which provided evidence the left foot wound was measured by the LPN's (EMP #2 and EMP #4) during the two (2) SN visits performed during the treatment week of 05/28/2023 through 06/03/2023 (EMP #2 on 05/31/2023 and EMP #4 on 06/02/2023). Patient #7: Between Jully 13, 2023 at approximately 12:45 PM and July 14, 2023 at approximately 9:35 AM, review of the clinical record revealed SN services are necessary to provide wound care and monitor wound healing and that SN is to assess/measure the external length of the intravenous (IV) catheter weekly as documented on the "Plan of Care" for the initial certification period of 05/25/203 through 07/23/2023. Review of "Physician Order Form" documentation dated 06/14/2023 revealed a physician order was obtained for SN to provide wound care to the stage 2 pressure ulcer (open wound) of the intergluteal cleft (butt crack)-wound #2). Review of clinical record documentation dated 06/14/2023 revealed wound #2 measured 1.16 centimeters (cm) by 0.53 cm (length by width). There was no documentation in the clinical record which provided evidence the intergluteal cleft wound was assessed during nine (9) of nine (9) SN visits conducted by RN's (EMP #1 and EMP #10) between 06/19/2023 and 07/12/2023. During home visit conducted on 07/12/2023 at approximately 10:50 AM, the RN (EMP #1) performed a dressing change for the right chest IV/central venous catheter (CVC). There was no documentation in the clinical record which provided evidence the RN's (EMP #1 and #10) assessed/measured the external length of the CVC during the weekly CVC dressing changes performed between 05/31/2023 and 07/12/2023. Patient #14 (Discharge): On July 14, 2023 at approximately 12:48 PM, review of the clinical record revealed the primary diagnosis was chronic obstructive pulmonary disease (COPD) with acute exacerbation (sudden worsening) and that SN was to assess lung sounds as documented on the "Plan of Care" for the initial certification period of 02/01/2023 through 04/01/2023. Review of "Visit Details" documentation dated 02/16/2023 revealed the LPN (EMP #2) documented the patient suffered from dyspnea (difficulty breathing). There was no documentation in the clinical record which provided evidence the LPN assessed the patient's lung sounds on 02/16/2023. Patient #16 (Discharge): On July 14, 2023 at approximately 2:25 PM, review of the clinical record revealed SN was assess pressure ulcer status and provide wound care to the lower spine/sacral wound and that rehabilitation potential included for the skin integrity impairment to decrease in size or heal prior to discharge as documented on the "Plan of Care" for the recertification period of 04/17/2023 through 06/15/2023. Review of "Visit Details" report documentation revealed two (2) SN visits were provided during the treatment week of 04/16/2023 through 04/22/2023 and that wound care was provided to the lower spine sacral wound during those SN visits. There was no documentation in the clinical record which provided evidence the RN (EMP #10) measured the above referenced wound on 04/18/2023 nor was documentation present which provided evidence the LPN (EMP #18) measured the aforementioned wound on 04/21/2023. During interview conducted on July 14, 2023 at approximately 3:45 PM, the Administrator and Nursing Supervisor/Clinical Manager confirmed SN assessments were not completed as per agency policy/procedure and/or physician orders for the above referenced patients.