Davita East Tampa Dialysis

“RO-CHEMICAL ANALYSIS-FREQUENCY CFR(s): 494.40(a) 6.2.7 Reverse osmosis: Chemical analysis: frequency Chemical analysis for the contaminants listed in 4.1.1 (Table 1) should be done when the RO system is installed, when membranes are replaced, and at not less than annual intervals thereafter to ensure that the limits specified in 4.1.1 are met (see Table 1). Chemical analyses should be done when seasonal variations in source water suggest worsening quality or when rejection rates fall below 90 %. This Standard is not met as evidenced by: 49691 Based on record review, policy review and interviews the facility failed to ensure Reverse Osmosis Water quality was tested annually as required by AAMI standards in the hemodialysis of 61 patients (current census) of 61 patients. Findings included: During review of the AAMI (Association for the Advancement of Medical Instrumentation) Water Quality Review, the test results were from March of 2023. Review of Policy 2-02-02 DaVita Inc., Origination August 2006, last updated April /2019, states “Water Analysis is to be performed and documented annually on the dialysis quality water.” During an interview on 070/8/2024 at 10:20 AM with Staff A, Biomedical technician, when provided the most recent AAMI water tests, Staff A confirmed that the annual AAMI test were last performed on March 2023.”

“PR-INFORMED OF INTERNAL GRIEVANCE PROCESS CFR(s): 494.70(a)(14) The patient has the right to- (14) Be informed of the facility’s internal grievance process; This Standard is not met as evidenced by: 34768 Based on interview and record review the facility failed to implement the grievance process to include the patient in the resolution process and agreement with that resolution in 2 of 2 grievances reviewed. Findings included: Review of the Patient Grievance Log for May 2024 showed two complaints. 1. Review of Patient #7’s Grievance / Investigation Document dated 05/13/2024 showed Patient #7 complained about bubbles in the dialysis line and the Registered Nurse (RN) did not change the line right away. Patient #7 was uncomfortable and no longer wanted that particular RN to care for him. He also complained about lack of continuity of care. The Grievance /Investigation Document showed in the Interview / Investigation Section, “teammate reports troubleshooting the machine and no air given to patient. Treatment resumed without incident.” The Describe the Plan for Resolution Section showed, “patient request not to have RN working with him accommodations have been made to honor patient request.” The form was signed by the Facility Administrator (FA)/Director of Nursing (DON) but not dated. The Grievance / Investigation Document lacked documentation the complainant / patient was informed of a possible resolution and agreed with that resolution. Review of the progress note dated 05/13/2024 by the Social Worker (MSW) showed FA asked MSW to speak with patient regarding him not wanting a certain RN to treat him. Patient said the incident happened in January 2024 when he had bubbles in his line and the nurse did not change it right away but tried thumping the line to remove bubbles and made it worse. Then she tried to piggyback a new line before having to completely change the set up and this left him feeling uncomfortable. Patient said staff is constantly changing and hard to get comfortable with new people setting him up. MSW initiated a grievance and spoke with the FA and she will follow up with the patient. MSW assured the patient that she is here for him as his advocate if he has concerns. 2. Review of Patient #8’s Grievance / Investigation Document dated 05/14/2024 showed the patient’s daughter called to say that her mom came home covered in blood. The patient’s shirt was soiled. Daughter was concerned about how weak the patient was. The patient was on blood thinners. The daughter stated the RN did not hold long enough to stop the bleeding. Social Worker notified the FA. The Grievance /Investigation Document revealed in the Interview / Investigation Section, “RN reports patient bleeding resumed post hemostasis. A clamp was applied, and no further bleeding was noted. Hemoglobin was obtained and remains within normal limits. Spoke with daughter and patient will be evaluated for UTI (Urinary Tract Infection).” The Describe the Plan for Resolution Section showed, “all staff are aware that patient doesn’t hold AV (arteriovenous) sit for hemostasis. Staff must ensure complete hemostasis of AV access sites. The from was signed but the date was a month and date only 5/16, it lacked a year. The Grievance / Investigation Document lacked documentation the complainant / patient was informed of a possible resolution and agreed with that resolution. Review of the progress note dated 05/14/2024 by the MSW, showed MSW initiated a grievance after speaking with the patient’s daughter. Patient came home Saturday after treatment with her shirt soiled in blood. Daughter was concerned because her mom takes blood thinners and she was very weak when she returned home from the loss of blood. The daughter has pictures and video she will share with staff. FA was notified and will speak with the daughter and patient. MSW will continue to provide support as needed. During an interview on 07/09/2024 at 11:06 a.m. the FA/DON, the Social Worker and the RN/Manager of Clinical Services reviewed the Grievance / Investigation Documents for Patients #7 and #8. They verified and agreed that both complaints lacked documentation that a resolution had been discussed with the patient and / or complainant and that the patient was satisfied with the resolution. They verified the documentation was not complete with specifics including dates and signatures of staff filling out the grievance forms. Review of the facility’s policy, “Patient Grievance,” revised October 2021 showed Purpose: to provide guidance on the patient grievance process. Grievances Generally: A. all patients of this facility have the right to have their grievances handled promptly and courteously. Internal Grievance Process: C. The FA (or her/his designee) is to discuss the grievance with the patient, investigate and take appropriate action towards a solution, if possible. This discussion should occur within 10 days of receipt of the grievance.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 34768 Based on interview and record review the facility failed to achieve and sustain the prescribed dose of dialysis to meet the prescribed Dialysate Flow Rate (DFR) for two of six sampled patients (#2, #6) and Blood Flow Rate (BFR) for one of six sampled residents (#6). Findings included: Review of the medical record showed Patient #2 was admitted to the facility on 04/10/2024 to receive dialysis three times a week with a Central Vascular Catheter. Review of the physician’s orders revealed a DFR of 800 milliliter/minute. On 06/24/2024 the DFR was documented as 780 ml/min for 1 of 9 assessments, 820 ml/min for 1 of 9 assessments and 830 ml/min for 1 of 9 assessments. On 06/26/2024 the DFR was documented as 830 ml/min for 3 of 11 assessments. On 06/28/2024 the DFR was documented as 500 ml/min for 6 of 11 assessments and 510 ml/min for 5 of 11 assessments. On 07/01/2024 the DFR was documented as 600 ml/min for 2 of 10 assessments, 610 ml/min for 7 of 10 assessments and 620 ml/min for 1 of 10 assessments. Review of the medical record showed Patient #6 was admitted to the facility on 10/23/2023 to receive dialysis three times a week with a Central Vascular Catheter and a reperformed Graft access. Review of the physician’s orders revealed a DFR of 800 ml/min and BFR of 400 ml/min. On 06/25/2024 the DFR was documented as 600 ml/min for 3 of 9 assessments, and 610 for 6 of 9 assessments. On 07/01/2024 the BFR was documented as 350 ml/min for 11 of 11 assessments. During an interview on 07/09/2024 at 9:35 a.m., the FA/DON verified the staff was to follow the physician’s orders related to DFR and BFR. FA/DON verified the DFR had not been followed for Patient #2. She verified the BFR and DFR had not been followed for Patient #6. She stated there should be justification documentation as to why the DFR and BFR was not followed. The physician notification should have been documented. Review of the facility’s policy, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revised April 2024 showed the scope of practice and other statutes, rules and regulations that impact the practice of the RN, LPN/LVN and PCT may vary among states. Purpose: to obtain and document baseline and ongoing information about the patient before, during and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment and for reviewing the patient’s response to the treatment and status prior to discharge. Policy: 2. The Nursing assessment will be performed and documented ...iii. verification of prescription including machine parameters. 3. Patient Identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. Prescription components include but are not necessarily limited to: f. Blood flow rate, g. Dialysate flow rate. Intradialytic Data Collection Assessment. 9b. At a minimum, obtain and document the following: iii. blood and dialysate flows, arterial and venous pressures. 10. If the dialysis prescription is not being met (including dialysis flow rate or change to / inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed.”

“QAPI-ONGOING;USES INDICATORS=IMPROVEMENT CFR(s): 494.110(a)(1) The program must include, but not be limited to, an ongoing program that achieves measurable improvement in health outcomes and reduction of medical errors by using indicators or performance measures associated with improved health outcomes and with the identification and reduction of medical errors. This Standard is not met as evidenced by: 34768 Based on interview and record review the facility failed to ensure the Quality Assessment and Performance Improvement (QAPI) continuously looked at indicators and trended outcomes and developed an improvement plan when indicated related to infection rates. Findings included: Review of the Infections Dashboard showed the infection rates for the Local Access Site was as follows: January 2024: 0.63% February 2024: 0.64% March 2024: 0.64% April 2024: 1.90% May 2024: 1.89% During an interview on 07/09/2024 at 12:20 p.m. with the the Facility Administrator / Director of Nursing (FA/DON) and Manager of Clinical Services (MCS) stated the goal was the infection rate to be under 0.5%. Review of the Infection Log showed Patient #2, #3 and #6 had infections in the month of May 2024. During an interview on 07/09/2024 at 12:20 p.m. the FA/DON stated Patient #3 was diagnosed with cellulitis of his Central Venous Catheter (CVC) and was placed on an antibiotic. FA/DON stated Patient #2 had drainage from his Central Venous Catheter site and was placed on antibiotics. FA/DON stated Patient #6 had drainage from his access and was placed on an antibiotic as a prophylactic. FA/DON stated another patient was added to the infection log for June 2024 due to a CVC and maturing access was admitted to the hospital, which had cultures and was positive for MRSA and was placed on an antibiotic. Review of the Monthly Infection Control Audit performed on 05/23/2024 showed one Patient Care Technician (PCT) and one Registered Nurse (RN) was observed for the following: supply management, hand hygiene, CVC initiation, pathogen-based precautions and station / training area disinfection. There was no documentation as to which staff member was observed. The Monthly Infection Control Audit for June 2024 was not performed per the FA/DON. Review of the ESRD Core Survey Facility Worksheet: Personnel File showed the facility employees a FA/DON, 2 RNs and 2 CCHTs (Certified Clinical Hemodialysis Technician) and 2 PCTs. One RN, both CCHT and the FA/DON had not had their annual skills competency testing. During an interview on 07/09/2024 at 12:20 p.m. with the FA/DON and the RN/Manager of Clinical Services (MCS) they stated they expected, based on the infection rate trends, to see education of staff as well as observation audits. The FA/DON stated she had not provided added infection control education to the staff. The last infection control education was in December 2023. The December 2023 education included CVC procedure and cross contamination, scrub hub and clear guard caps. After reviewing the sign in sheet of the in-service, the FA/DON stated only one RN and one PCT are currently working at the facility that attended the in-service. They stated that the Monthly Infection Control Audit dated 05/23/2024 showed one PCT and one RN were audited. They verified the specific staff audited was not documented on the Monthly Infection Control Audit. The FA/DON stated she was unable to provide the names of the staff members that had been audited. The FA/DON stated an audit had not been performed in June 2024 as per protocol. The FA/DON stated all the staff performed computer classes which included Infection Control Training in April 2024 but it did not include any hands on or competencies. The FA/DON and the MCS stated the expectation was to perform visual audits monthly, but they have no way of tracking which staff was audited. The FA/DON stated the staff member performing the audits prior was no longer with the facility and it was the responsibility of her (FA/DON) to perform. The FA/DON and the MCS stated that they report the infection rate monthly at Quality Meeting and it was discussed with the Medical Director. The FA/DON stated they had not put a Performance Improvement Plan in place regarding the trending infection control rate. Review of the facility’s policy, “Continuous Quality Improvement Program,” revised 2021 showed the Purpose: to improve patient safety and outcomes including the reduction of medical errors in accordance with the Quality Assessment and Performance Improvement (QAPI) requirements in t4h CMA Conditions of Coverage. Policy: 7. Th 4facilty will measure, analyze, and track quality indicators or other aspects of performance. Ther program must include, but not limited to, the following: “ Infection Control, including o Incidence of infections 8. Continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperfoprmance3, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained. 9. Each plan will be evaluated as to priority with Patient Safety and Clinical Outcomes indicators considered for the highest level of priority.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 34768 Based on interview and record review the facility failed to ensure 4 (Staff A,B,C and Facility Administrator/Director of Nursing) of 7 dialysis facility staff members demonstrated yearly competencies required to serve the complex needs of dialysis patients. Findings included: Review of the ESRD Core Survey Facility Worksheet: Personnel File, completed by the FA/DON on 07/08/2024 showed the facility employs a Facility Administrator/Director of Nursing (FA/DON), 2 Registered Nurses (RN) and 2 Certified Clinical Hemodialysis Technicians (CCHT) and 2 Patient Care Technicians (PCT). The document showed for Staff A RN, she began employment on 04/10/2023 and last had annual skills competency testing documented on 06/02/2023. The document showed for Staff B, CCHT, she began employment on 05/18/2015 and last had annual skills competency testing documented on 06/30/2023. The document showed for Staff C, CCHT, she began employment on 04/06/2020 and last had annual skills competency testing documented on 05/29/2020. The document showed for FA/DON,she began employment on 10/26/2015 and last had annual skills competency testing documented on 06/30/2023. During an interview on 07/09/2024 at 12:20 p.m. with the FA/DON and the RN/Manager of Clinical Services (MCS) they stated they had not provided added infection control education to the staff. The last infection control education was in December 2023. The December 2023 education included CVC procedure and cross contamination, scrub hub and clear guard caps. After reviewing the sign in sheet of the in-service, the FA/DON stated only one RN and one PCT are currently working at the facility that attended the in-service. The FA/DON stated all the staff performed computer classes which included Infection Control Training in April 2024 but it did not include any hands on or competencies. Review of the facility’s policy, “Teammate Qualifications, Licensure and Adequate Teammate Staffing,” revised October 2017 showed 3. The dialysis facility’s teammates will meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s teammates will have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions.”