Amatus Health Care LLC

“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 observation, interview and record review, the agency failed to inform the Pt in advance about the care to be provided and failed to obtain written informed consent outlining the type of care and services to be provided by the agency for 1 of 4 Pts (Pt #1) whose medical records were reviewed in that RN A performed a medical procedure on Pt #1 without informing Pt #1 of the procedure prior to performing it and without obtaining written informed consent. This failure placed the Pts at risk of receiving care or services without the opportunity to understand the care, make an informed decision regarding the care, and provide or decline consent prior to care. Findings include: Review of TULIP, a database utilized by the state to maintain licensing, demographic information, complaints, and self-reported incidents on home health and hospice agencies for the state of Texas was conducted. An entrance conference was conducted with agency Admin on 8/18/2026 at approximately 10:15 AM. The purpose of the survey was relayed to the Admin. Requests for agency documents including complaint log, current Pt census, discharged Pts for the previous 6 months were made. Record review of Pt #1 medical record revealed no start of care or face to face admission conducted. The clinical record only contained communication notes. Review of communication note dated 4/14/2025 revealed request for Pt #1 to be admitted with a start of care date 4/16/2026 to have PICC (a long flexible tube that doctors insert into a vein in the upper arm that is used to give medication), removed. Review of communication note written by RN A in Pt #1’s medical record dated 4/16/2025 read in part, “… while attempting to change the PICC line dressing… the PICC line was found on the table with blood coming out of the site of the line. Site cleaned up and covered with gauze and securely taped, then the family will go to the hospital for line placement…”. Surveyor requested that Admin confirmed Surveyor access to all documents in the clinical record. Agency complaint log contained a “complaint/grievance report”, dated 5/20/2025 written by DON B, contained a document summarizing the incident. The document read in part, “… [RN A] confirmed that consent was not obtained prior to starting a dressing change. Per [RN A] he did forget to obtain consent prior to starting dressing change but does acknowledge importance of obtaining consent prior to laying hands on a patient”. DON B was interviewed via telephone on 8/18/2026 at approximately 1:50 PM. Surveyor asked DON B what she recalled of the incident. DON B stated that there was an order to take out the PICC like that RN A did not see therefore he thought he was only doing an admission and dressing change. RN A went out to the Pt’s house to do an admission and do a PICC line dressing change.. DON B stated that their agency doesn’t typically receive orders to admit to take out a PICC line and that ultimately, the Pt did not get admitted to services because she chose to go with a different agency after she went to the hospital. DON B stated that RN A acknowledged he did not obtain consent from the Pt and accepted ultimate responsibility for the situation. Surveyor was unable to locate an order for the PICC line. An interview with FM 1 was conducted via telephone on 8/18/2026 at 1:56 PM. Surveyor asked FM 1 if she felt it would benefit the Pt to have a home visit. FM 1 stated she believed it would help Pt #1 a lot because she was still very traumatized by the ordeal. FM 1 stated she would obtain all documents she had and would have it available for Surveyor review. Observation and interview with Pt #1 and FM 1 were conducted during a home visit on 8/19/2026 at approximately 10:15 AM. FM 1 was present and assisted Pt #1 in retelling the situation. Pt #1 and FM 1 stated that RN A did not make them aware of the procedure that he was about to do and he did not obtain Pt #1’s consent prior to attempting to change the PICC line dressing. Per Pt #1 she believed that RN A was there to change the PICC line dressing. After RN A took the dressing off, RN A encouraged Pt #1 to place a facemask on. Pt #1 struggled to place the facemask, so RN A helped her with the mask placement. When RN A returned his focus back to the PICC line, it was found on the table. Pt #1 stated that RN A “ran from the house when I started bleeding and we were 100% on our own”. Surveyor asked Pt #1 if RN A provided her with an agency admission folder, Pt rights policies, or consents to review prior to the RN A attempting to remove the dressing from her PICC line. Pt #1 stated that RN A never conducted an assessment, informed her of the procedure, or provided Pt rights prior to putting his hands on her. FM 1 stated “this was no mistake, this was negligence”. An interview was conducted with Admin and Alt Admin/ DON on 8/19/2026 at approximately 12:30 PM. Surveyor asked why the admission information was deleted from the clinical record. Admin stated that it isn’t uncommon for incomplete paperwork to be deleted on Pts who are not admitted to the agency. Surveyor asked the Admin and Alt Admin/ DON what they knew of the incident. Admin stated this occurred before he was hired at the agency and that DON B was responsible for deleting the admission paperwork from the clinical record. An interview with RN A was attempted on 8/20/2026 at 1:00 PM. RN A did not answer or return Surveyor’s call. An exit interview was conducted with Alt Admin/ DON on 8/20/2026 at 1:30 PM. Surveyor asked for the standard procedures for PICC line removal/ dressing changes. Alt Admin/ DON provided Surveyor with their procedures book. Surveyor asked Alt Admin/ DON if this was standard to perform a procedure before obtaining consent. Alt Admin/ DON stated it’s never standard to touch a Pt without consent. Alt Admin stated the policy was to obtain consent first. Review of agency policy titled “Patient Bill of Rights and Responsibilities/ Right of the Elderly” (no date) read in part, “…agency must ensure that written informed consent specifying the type of care and services that may be provided by the agency has been obtained for every patient or their legal representative”.”