Concerned Care Home Health, Inc.

“Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This Standard is not met as evidenced by: Based on record review and interviews, the agency failed to encode and electronically transmit each completed OASIS (Outcome and Assessment Information Set) as evidenced by failing to ensure the agency successfully completed and transmitted OASIS data within 30 days of completion of the assessment of the beneficiary. Findings: Findings: Review of CMS’s (Center for Medicare and Medicaid Services) Standard Regulation Text titled “CFR (Code of Federal Regulations) Section 484.45(a)” revealed: A home health agency must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. Review of the agency’s Oasis Detail Error Report dated 04/01/2024 to 06/18/2024 revealed 20 Oasis assessments with error code -3330 were submitted more than 30 days after the date of completion on the record, which was late. On 06/27/2024 at 3:00 p.m., a phone interview was conducted with S7OM. S7OM confirmed she was responsible for all OASIS submissions. She verified the aforementioned Oasis records reviewed were submitted more than 30 days after the completion date on the record and were late. On 06/27/2024 at 3:05 p.m., an interview was conducted with S1DCS. S1DCS confirmed S7OM was responsible for the submission of all Oasis data. S1DCS further confirmed she did not review the validation reports for accuracy, including if any submissions were late, or > 30 days of the completion date. SIDCS reviewed the validation reports dated 04/01/2024- 06/18/2024 and confirmed the OASIS assessments on these dates with error code -3330 were submitted more than 30 days after the completion date on record and were late.”

“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 observations, interviews, and record reviews, the HHA failed to ensure staff followed accepted standards of infection control practices for 3 (Patients #1, #6, #7) of 7 (Patients #1, #2, #3, #4, #5, #6, and #7) patients observed during home visits. The agency staff failed to: 1. Ensure staff properly disinfected reusable equipment used during home visits with Patients #1, #6, #7; and 2. Practice proper bag barrier technique while providing care to Patients #6 and #7. Findings: Review of the undated Agency’s Competency Training titled “Bag Technique” included the following, in part: Purpose: to decrease spread of infection from patient to patient. Expectations: All supplies that have touched a patient/unclean surface will be considered dirty until they have been cleaned with an antimicrobial wipe. (ex. B.P. cuff, thermometer, etc). All employees will equip themselves with a disposable waterproof barrier to protect bags. Visit Process: Place bag on waterproof barrier in home. Remove B.P. cuff, thermometer and other supplies needed for visit from bag and place on clean barrier. Take patient vitals and proceed with assessment. Clean all supplies (B.P. cuff, stethoscope, thermometer, etc.) with antimicrobial wipe and place back into clean portion of bag. 1. Patient #1 Review of the clinical record revealed the patient had a SOC (Start of Care) date of 06/08/2024. A review of the 485/PoC (Plan of Care) for the certification period of 06/08/2024 – 08/06/2024 revealed Orders and Treatments, which included the following: SN (Skilled Nurse) 1day1, then 1w9. On 06/25/2024 at 9:05 a.m., an observation and interview were conducted in the home of Patient #1 with S2LPN present. S2LPN was observed taking the patient’s blood pressure, temperature, and pulse oximetry reading. After completing the vital sign assessment, S2LPN returned her reusable blood pressure cuff, stethoscope, thermometer, and pulse oximeter to her bag without properly disinfecting her equipment. S2LPN verified she did not have any antimicrobial wipes on hand and did not clean her reusable equipment before returning them to her bag. Patient #6 Review of the clinical record revealed the patient had a SOC (Start of Care) date of 12/16/2023. A review of the 485/PoC for the certification period of 06/13/2024- 08/11/2024 revealed Orders and Treatments, which included the following: SN 1w1, 3w8. On 06/26/2024 at 8:52 a.m., an observation and interview were conducted in the home of Patient #6 with S3RN present. S3RN was observed taking the patient’s blood pressure, temperature and performing a pulse oximetry reading. After completing the vital sign assessment, S3RN returned her reusable blood pressure cuff, stethoscope, thermometer and pulse oximeter to her bag/box without properly disinfecting her equipment. S3RN verified she did not have any antimicrobial wipes on hand and did not clean her reusable equipment before returning them to her bag/box. Patient #7 Review of the clinical record revealed the patient had a SOC date of 02/23/2024. A review of the 485/PoC for the certification period of 06/22/2024- 08/20/2024 revealed original Orders and Treatments which included the following: SN 2w2, 3w3. On 06/26/2024 at 9:25 a.m., an observation and interview were conducted in the home of Patient #7 with S3RN present. S3RN was observed taking the patient’s blood pressure, temperature, and pulse oximetry reading. After completing the vital sign assessment, S3RN returned her reusable blood pressure cuff, stethoscope, thermometer, and pulse oximeter to her bag/box without properly disinfecting her equipment. S3RN confirmed she had not properly disinfected her equipment using antimicrobial wipes before returning them to her bag/box and should have. On 06/27/2024 at 2:55 p.m., an interview was conducted with S1DCS. S1DCS confirmed all staff should clean reusable equipment with antimicrobial wipes before returning them to their bag. 2. Patient #6 Review of the clinical record revealed the patient had a SOC date of 12/16/2023. A review of the 485/PoC for the certification period of 06/13/2024- 08/11/2024 revealed Orders and Treatments, which included the following: SN 1w1, 3w8. On 06/26/2024 at 8:52 a.m., an observation and interview were conducted in the home of Patient #6 with S3RN present. S3RN was observed placing her equipment box on the patient’s dining table without a barrier between the box and table. S3RN verified she did not use a barrier between her box and patient’s table and should have. Patient #7 Review of the clinical record revealed the patient had a SOC date of 02/23/2024. A review of the 485/PoC for the certification period of 06/22/2024- 08/20/2024 revealed original Orders and Treatments which included the following: SN 2w2, 3w3. On 06/26/2024 at 9:25 a.m., an observation and interview were conducted in the home of Patient #7 with S3RN present. S3RN was observed placing her equipment box on the patient’s side table without a barrier between the box and table. S3RN verified she did not use a barrier between her box and patient’s table and should have. On 06/27/2024 at 2:55 p.m., an interview was conducted with S1DCS. S1DCS confirmed all staff should use a waterproof barrier to place their bag/box on during patient visits.”

“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 observations, record reviews, and interviews, the agency failed to ensure the medication profile accurately reflected all medications patients were using, and/or did not reflect medications the patients were no longer using, for 4 (Patient #1, #2, #6 and #7) of 7 (Patients #1- #7) sampled patients reviewed who received home visits. Findings: Patient #1 Review of the clinical record revealed the patient had a SOC (Start of Care) date of 06/08/2024. The patient’s current diagnoses included Type 2 Diabetes Mellitus with Diabetic Chronic Kidney Disease. A review of the 485/PoC (Plan of Care) for the certification period of 06/08/2024-08/06/2024 revealed Orders and Treatments, which included the following: SN 1day1, then 1w9. A current medication profile list was provided by the agency on 06/25/2024. On 06/25/2024 at 9:05 a.m., a visit and interview were conducted at Patient #1’s home with S2LPN present. Patient #1 stated his daughter setup his medications. His daughter was unavailable and not present during the home visit. The current medication profile list provided by the agency for Patient #1 was reviewed with S2LPN and revealed the following discrepancies: 1. Zyrtec 10mg one tablet by mouth daily. This medication was listed as a current medication on the patient’s medication list provided by the agency. There were no Zyrtec tablets available in the home. 2. Bupropion HCL ER (XL) 300mg one tablet by mouth daily. This medication was listed as a current medication on the patient’s medication list provided by the agency. There were no Bupropion tablets available in the home. A review of SN visit documentation revealed SN visits were conducted with Patient #1 on the following dates during the current Certification Period of 06/08/2024 to present: 06/15/2024 and 06/21/2024. S2LPN verified Patient #1’s medication list had not been updated to reflect the current medications he was taking and should have. Patient #2 Review of the clinical record revealed a start of care date of 04/17/2024. A review of the Home Health Certification and Plan of Care/485 for the Certification Period of 06/16/2024- 08/14/2024 revealed a primary diagnosis of Hypertensive Heart and Chronic Kidney Disease Stage 1-4 and orders, which included SN 1w8 effective week of 08/01/2021. A current medication profile list was provided by the agency on 06/25/2024. On 06/25/2024 at 10:05 a.m., a visit and interview were conducted at Patient #2’s home with S2LPN present. The current medication profile list provided by the agency for Patient #2 was reviewed with the Assisted Living facility (ALF) nurse and S2LPN and revealed the following discrepancies: 1. A bottle of Zinpep DR 20,000 units 1 capsule by mouth three times daily, with a prescription fill date of 06/13/2024 was provided by the ALF nurse. This medication was not listed as a current medication on Patient #2’s medication profile list. A review of SN visit documentation revealed SN visits were conducted with Patient #2 on the following dates during the current Certification Period of 06/16/2024 to present: 06/18/2024 and 06/25/2024. The ALF nurse verified she administered Patient #2’s medications daily and stated Patient #1’s new Zinpep DR medication was started on 06/13/2024. S2LPN verified Patient #2’s medication list had not been updated to reflect the current medications she was taking and should have been. Patient #6 Review of the clinical record revealed a start of care date of 12/16/2023. A review of the Home Health Certification and Plan of Care/485 for the Certification Period of 06/13/2024 to 08/11/2024 revealed a primary diagnosis of Hypertensive Heart and Chronic Kidney Disease with Heart Failure and Stage 1-4 Chronic Kidney Disease and orders which included SN 1w1, 3w8. A current medication profile list was provided by the agency on 06/25/2024. Review of the physician’s order dated 06/21/2024 for Patient #6 signed by S3RN revealed: Problem: Rash to lower extremities New order: Apply barrier cream to skin as needed for rash or irritation. On 06/26/2024 at 8:52 a.m., a visit and interview were conducted at Patient #6’s home with S3RN and Patient #6’s sitter present. Patient #6’s spouse was not present in the home. Patient #6 stated her husband prepared all of her medications weekly. Patient #6’s sitter stated she was not familiar with the patient’s medications and did not prepare her medications. The current medication profile list provided by the agency for Patient #6 was reviewed with S3RN and revealed the following discrepancies: 1. Boudreaux’s Butt Paste a.k.a. Barrier Cream was not listed on the current medication list provided by the agency. A review of SN visit documentation revealed SN visits were conducted with Patient #6 on the following dates during the current Certification Period of 06/13/2024 to present: 06/14/2024, 06/18/2024, 06/19/2024, 06/22/2024, and 06/26/2024. S3RN verified Patient #6’s medication list had not been updated to reflect the current medications she was taking and should have been. Patient #7 Review of the clinical record revealed a start of care date of 02/23/2024. A review of the Home Health Certification and Plan of Care/485 for the Certification Period of 06/22/2024 to 08/20/2024 revealed a primary diagnosis of Pressure Ulcer of Other Site, Stage 4 and orders which included SN 2w2, 3w3 effective 06/13/2024. A current medication profile list was provided by the agency on 06/25/2024. On 06/26/2024 at 9:25 a.m., a visit and interview were conducted at Patient #7’s home with S3RN present. Patient #7 verified he was familiar with his medications and managed them himself. Review of the medications listed on Patient #7’s current medication profile list provided by the agency revealed the following discrepancies when compared with medications in the home: 1. Ozempic 2mg/1.5ml Inject 1ml daily. The patient stated he has no longer is taking this medication due to cost and has not taken this medication in several weeks. 2. Doxcycline Hyclate 100mg tablet by mouth every 12 hours. The patient stated he no longer is taking this medication and has not taken this medication in several weeks. 3. Metoprolol 100mg one tablet twice a day. There was no medication bottle to review in the home, and the patient stated he has been taking this medication for over 3 years. A review of SN visit documentation revealed SN visits were conducted with Patient #7 on the following dates during the current Certification Period of 06/22/2024 to present: 06/26/2024. Review of prior cert period 04/23/2024-06/21/2024 revealed SN visit was last conducted on 06/21/2024 for recertification. S3RN verified Patient #7’s medication list had not been updated to reflect the current medications he was taking and should have been. On 06/27/2024 at 3:05 p.m., an interview was conducted with S1DCS. She was notified of the medication discrepancies found during the home visits for Patients #1, #2, #6, and #7. She verified the medication profiles were not up to date. S1DCS confirmed nurses should reconcile medications during each SN visit and update the medication profiles accordingly.”

“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: Findings: Review of the agency’s policy titled “Care Planning Process” dated November 2017 revealed the following, in part: Policy: The care planning process will be documented on the plan of care, individualized discipline specific care plans, and clinical notes. 3. Based on the assessment and conclusions, the plan of care will include: A. Patient specific interventions and education. D. Specific services and treatments to be provided. 5. Will be based on physician’s orders and will encompass the equipment, supplies, and services required to meet the patient’s needs. Review of the agency’s undated policy titled “Wound Care Protocol” revealed, in part: Wounds must match Physician’s Orders. Measurements should be done at least weekly. Prescribing physician or NP (Nurse Practitioner) must be notified of any changes in wounds. 1. Patient #4 Review of Patient #4’s Clinical Record revealed she was admitted to the agency on 05/14/2024 with diagnoses, which included Infection/Inflammation Reaction Due to Internal Right Knee Prosthesis, Initial Encounter and Type 2 Diabetes Mellitus with Foot Ulcer, and Non-Pressure Chronic Ulcer Other Part Right Foot. Review of Patient #4’s Plan of Care for certification period of 05/14/2024 to 07/12/2024 revealed Physician Orders, which included the following, in part: Skilled Nurse (SN): 2w2, 1w7. SN to perform and instruct wound care on the right third toe: paint with Betadine, cover with island dressing/border daily. Caregiver may perform on alternate days of skilled nurse visit. SN to perform and instruct wound care on the right third toe: cleanse with soap and water, pat dry, and apply antifungal skin barrier ointment 2 times a day and as needed soilage. Caregiver may perform on alternate days of skilled nurse visit. SN to perform and instruct wound care to right knee: Surgical dressing in place. Remove dressing after 7 days (05/19/2024). After removal, clean with alcohol and place silver dressing to site. Review of the Client Calendar Report for Patient #4 revealed Skilled Nurse visits were conducted on: 05/14/2024, 05/16/2024, 05/20/2024, 05/24/2024, 05/30/2024, 06/07/2024, 06/10/2024, 06/13/2024, 06/19/2024, and 06/26/2024. Review of Patient #4’s clinical nursing notes dated 05/24/2024, 05/30/2024, and 06/13/2024 revealed no wound care had been provided per Physician’s Orders and no wound measurements were performed. No documentation provided by the agency indicated the patient’s caregiver had provided the wound care on those dates. On 06/27/2024 at 3:15 p.m., an interview was conducted with S1DCS. She reviewed Patient #4’s Clinical Record and confirmed wound care should have been provided per physician’s orders/Plan of care and wounds measured at least weekly on the aforementioned dates and was not. 2. Patient #6 Review of Patient #6’s Clinical Record revealed she was admitted to the agency on 12/16/2023 with diagnoses, which included Hypertensive Heart and Chronic Kidney Disease with Heart Failure and Stage 3 Chronic Kidney Disease. Review of Patient #6’s Plan of Care for certification period of 04/14/2024 to 06/12/2024 revealed Physician Orders, which included the following, in part: Skilled Nurse (SN) effective week of 04/15/2024 2w8, 1w1. SN to perform wound care on the left lower extremity: Cleanse with Hibiclens, wrap with unna boot and Coban, wound care to be performed 3 times a week. Caregiver may perform wound care on alternate days of skilled nurse visit. Review of the Client Calendar Report for Patient #6 revealed Skilled Nurse visits were conducted on 04/29/2024, 05/03/2024, 05/06/2024, 05/10/2024, 05/13/2024, 05/17/2024- Missed visit, 05/20/2024, 05/24/2024, 05/31/2024, 06/03/2024, 06/05/2024, 06/07/2024, and 06/10/2024. Review of Nurses notes dated 04/29/2024 by S3RN revealed, in part: Seen by [Wound Care Clinic Provider]. Will discontinue unna boots temporarily and see if blisters and redness return to bilateral lower extremities. Edema still 2+. Further record review revealed there was no written, signed Physician Orders provided by the agency for unna boot discontinuation on 04/29/2024. Review of Nurses notes dated 05/03/2024 by S3RN revealed in part: Wound assessment: left lower extremity skin lesion. Treatment: cleansed with normal saline, applied unna boot and covered with Coban. Further record review revealed no written, signed Physician Orders provided by the agency for unna boots to be resumed on 05/03/2024. Review of Nurses notes dated 05/06/2024 by S3RN revealed in part: Wound assessment: left lower extremity skin lesion. Status: Closed. Further review revealed there was no written Physician Orders provided by the agency for the discontinued wound care as of 05/06/2024. Review of Nurses notes dated 05/31/2024 by S3RN revealed in part: There are two areas of concern to patient’s left and right leg. Re-evaluate at next visit. Further record review revealed there was no communication documented in the clinical record Patient #6’s physician had been notified of the skin changes. Review of Nurses notes dated 06/03/2024 by S3RN revealed in part: Right leg has several blisters. SN cleaned with normal saline and applied barrier cream to site. Further record review revealed there were no updated wound care orders approved by Patient #6’s physician for wound care provided by S3RN to Patient #6’s right leg on 06/03/2024. Review of Patient #6’s Plan of Care for certification period of 06/13/2024 to 08/11/2024 revealed there were no Physician Orders for wound care. Review of the Client Calendar Report for Patient #6 revealed Skilled Nurse (SN) visits were conducted on: 06/14/2024, 06/18/2024, 06/19/2024, 06/22/2024, and 06/26/2024. Review of Nurses notes dated 06/19/2024 by S3RN revealed, in part: Wound assessment: Buttocks, Open, onset 06/14/2024, Rash. Treatment: Cleansed with normal saline, barrier cream applied. Further record review revealed there were no updated wound care orders approved by Patient #6’s physician for wound care provided by S3RN to Patient #6’s buttocks on 06/19/2024. Review of Nurses notes dated 06/22/2024 by S3RN revealed, in part: Wound assessment: Buttocks, Open, onset 06/14/2024, Rash, Treatment: cleansed with normal saline, barrier cream applied. Further record review revealed no updated wound care order provided by the agency to apply barrier cream to Patient #6’s buttocks or bilateral lower extremities. Review of Physician’s Orders provided by the agency on 06/26/2024, dated 06/21/2024, and written by S3RN revealed: Problem: Rash to lower extremities New Order: Apply barrier cream to skin as needed for rash or irritation 06/21/2024. Further review revealed there was no updated wound care order provided by the agency to apply barrier cream to Patient #6’s buttocks. On 06/26/2024 at 9:00 a.m., an interview was conducted with S3RN during a home visit with Patient #6. S3RN confirmed Patient #6’s unna boots were discontinued recently after a visit to the wound care physician’s clinic but she had not received or written Physician Order to discontinue the unna boots, and she did not clarify the orders. S3RN confirmed she had not written or requested updated wound care orders for wound care provided after 04/29/2024 on the aforementioned dates to Patient #6’s lower extremities or buttocks and should have. On 06/27/2024 at 3:00 p.m., an interview was conducted with S1DCS. S1DCS reviewed the Physician Orders for wound care for Patient #6. She confirmed there was no documentation available in Patient #6’s clinical record indicating the discontinuation of unna boots on 04/29/2024, resumption of unna boots on 05/03/2024, or discontinuation of unna boots on 05/06/2024. S1DCS confirmed S3RN should have notified Patient #6’s physician when skin changes were identified during her assessment 05/31/2024. S1DCS confirmed there were no approved physician orders available for wound care provided by S3RN on 06/03/2024 for application of barrier cream to Patient #6’s right lower extremity or for wound care provided by S3RN on 06/19/2024 for barrier cream application to Patient #6’s buttocks as needed for rash. S1DCS confirmed S3RN should have requested physician approval of wound care orders provided to Patient #6 prior to performing wound care on the aforementioned dates and did not.”

“Documentation of inservice training CFR(s): 484.80(d)(2) The HHA must maintain documentation that demonstrates the requirements of this standard have been met. This Element is not met as evidenced by: Based on interview and record reviews, the agency failed to maintain documentation of annual abuse and neglect training for 11 of 11 (S1DCS, S2LPN, S3RN, S4RN, S5OT, S6PT, S8HHA, S9HHA, S10HHA, S11HHA and S12HHA) employee personnel files reviewed, in accordance with federal regulation requirements. Findings: Record review of the agency’s undated policy titled, “Assessment of Possible Abuse and Neglect” revealed, in part: Policy This policy will be reviewed annually with each employee. Each employee will sign an attestation of acknowledgement. Record Review of S1DCS’s personnel file revealed a hire date of 08/16/2021. There was no documented evidence of annual abuse and neglect training completed since 08/11/2022. Record Review of S2LPN’s personnel file revealed a hire date of 04/17/2023. There was no documented evidence of annual abuse and neglect training completed since date of hire. Record Review of S3RN’s personnel file revealed a hire date of 11/23/2020. There was no documented evidence of annual abuse and neglect training completed since 08/11/2022. Record Review of S4RN’s personnel file revealed a hire date of 02/09/2024. There was no documented evidence of annual abuse and neglect training completed upon date of hire. Record Review of S5OT’s personnel file revealed a hire date of 02/01/2017. There was no documented evidence of annual abuse and neglect training completed since 08/11/2022. Record Review of S6PT’s personnel file revealed a hire date of 09/10/2019. There was no documented evidence of annual abuse and neglect training completed since 08/11/2022. Record Review of S8HHA’s personnel file revealed a hire date of 12/16/2022. There was no documented evidence of annual abuse and neglect training completed since 12/16/2022. Record Review of S9HHA’s personnel file revealed a hire date of 10/03/2016. There was no documented evidence of annual abuse and neglect training completed since 08/11/2022. Record Review of S10HHA’s personnel file revealed a hire date of 01/17/2023. There was no documented evidence of annual abuse and neglect training completed upon date of hire and at least annually. Record Review of S11HHA’s personnel file revealed a hire date of 12/05/2022. There was no documented evidence of annual abuse and neglect training completed upon date of hire and at least annually. Record Review of S12HHA’s personnel file revealed a hire date of 10/25/2021. There was no documented evidence of annual abuse and neglect training completed since 08/11/2022. On 06/27/2024 at 3:00 p.m., an interview was conducted with S1DCS. S1DCS stated she was unaware abuse and neglect training was required at least annually and was unable to provide any documented evidence of abuse and neglect training provided to any newly hired employees in the last 12 months or to any existing employees since 2022. S1DCS confirmed the aforementioned employees had not received annual abuse and neglect training and should have.”