University Of Miami Hospital And Clinics -

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at UNIVERSITY OF MIAMI HOSPITAL AND CLINICS - CORAL SPRINGS on August 18, 2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) (b)(8)(i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; This STANDARD is not met as evidenced by: Based on record review and staff interview, the Technical Consultant (TC) or a designee failed to do direct observation of patient testing during competency evaluation for testing personnel (TP) for one out three TP in 2025. Findings included: 1-Review of FORM CMS 209 signed by the Laboratory Director on 08/18/2025, revealed the following: Laboratory Director (LD) was also Clinical Consultant and Technical Supervisor for Hematology specialty. The laboratory had one Technical Consultant (TC) for Chemistry specialty, had two General Supervisors (GS) for Hematology specialty (GS)#1 that was also TP#3 and GS#2 and TP#1, TP#2. 2- Review of personnel records revealed that annual competency for TP#3 for the Integra 400 in Chemistry specialty, revealed that the annual competency for patient testing was observed by TP#2 on 08/08/2025. TP#2 had no delegation letter to do competency. 3-During an interview on 08/18/2025 at 12:30 PM, the GS#1 confirmed that the TC failed to observe patient testing observation during annual competency for TP#3 on 08/08/2025. D6050 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iv) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- (b)(8)(iv) Direct observation of performance of instrument maintenance and function checks; This STANDARD is not met as evidenced by: Based on record review and staff interview, the Technical Consultant (TC) or a designee failed to do direct observation of performance of instrument and function check during competency evaluation for one testing personnel (TP) out of three on 2025. Findings included: 1-Review of FORM CMS 209 signed by the Laboratory Director on 08/18/2025, revealed the following: Laboratory Director (LD) was also Clinical Consultant and Technical Supervisor for Hematology specialty. The laboratory had one Technical Consultant (TC) for Chemistry specialty, had two General Supervisors (GS) for Hematology specialty (GS)#1 that was also TP#3 and GS#2 and had P#1, and TP#2. 2-Review of personnel records revealed that annual competency for TP#3, the direct observation of performance of instrument and function check for Integra 400 for Chemistry specialty was observed by TP#2 on 08/08 /2025. TP#2 had no delegation letter to do competency. 3-During an interview on 08 /18/2025 at 12:30 PM, the GS#1 confirmed that the TC failed to do direct observation of performance of instrument and function check during annual competency for TP#3 on 08/08/2025. D6121 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to-- (b)(8)(i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; This STANDARD is not met as evidenced by: Based on record review and staff interview, the Technical Supervisor (TS) or a designee failed to do direct observation of patient testing during competency evaluation for one testing personnel (TP) out of three in 2025. Findings included: 1- Review of FORM CMS 209 signed by the Laboratory Director on 08/18/2025, revealed the following: Laboratory Director (LD) was also Clinical Consultant and Technical Supervisor for Hematology specialty. The laboratory had one Technical Consultant (TC) for Chemistry specialty, had two General Supervisor (GS), (GS)#1 that was also TP#3 and GS#2 and had TP#1 and TP#2. 2-Review of personnel records revealed that annual competency for TP#3 for the Sysmex XN-10 for Hematology specialty, patient testing was observed by TP#2 on 08/08/2025. TP#2 had no delegation letter to do competency. 3-During an interview on 08/18/2025 at 12:30 PM, the GS confirmed that the TS failed to do direct observation of patient testing during annual competency for TP#3 on 08/08/2025. D6124 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(iv) (b)(8)(iv) Direct observation of performance of instrument maintenance and function checks; This STANDARD is not met as evidenced by: Based on record review and staff interview, the Technical Supervisor (TS) or a -- 2 of 3 -- designee failed to do direct observation of performance of instrument and function check during competency evaluation for one out of three testing personnel (TP) on 2025. Findings included: 1-Review of FORM CMS 209 signed by the Laboratory Director on 08/18/2025, revealed the following: Laboratory Director (LD) was also Clinical Consultant and Technical Supervisor for Hematology specialty. The laboratory had one Technical Consultant (TC) for Chemistry specialty, had two General Supervisors (GS)#1 that was also TP#3 and GS#2 and had TP#1 and TP#2. 2- Review of personnel records revealed that annual competency for TP#3, direct observation of performance of instrument and function check for Sysmex XN-10 for Hematology specialty was observed by TP#2 on 08/08/2025. TP#2 had no delegation letter to do competency. 3-During an interview on 08/18/2025 at 12:30 PM, the GS#1 confirmed that the TS or a designee failed to do direct observation of performance of instrument and function check during annual competency for TP#3 on 08/08/2025. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 02/15/2024 found the UNIVERSITY OF MIAMI HOSPITAL AND CLINICS - CORAL SPRINGS clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and staff interview, the current laboratory director (LD) failed to sign proficiency testing (PT) attestation for one out of four events reviewed for the specialty of Hematology. Findings Include: -Review of notification from the Laboratory & In-Home Services Unit Agency for Healthcare Administration revealed that the current LD was approved on 09/27/2022. -Review of the College of American Pathologists (CAP) records for the Hematology specialty for 2022 and 2023 revealed the following for the third event of 2022: the results were submitted on 10/05/2022 and the attestation for the event of refence was not signed by the LD instead was signed by a supervisor that at the time of the event was not signed as a designee by the curent LD. During an interview on 02/15/2024 at 12:00 PM, the current supervisor confirmed that the LD failed to sign the attestation for the event of reference. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review and interview, the current laboratory director (LD) failed to approve, sign and date the procedure manual before use after her approval as LD. Findings included: -Review of notification from the Laboratory & In-Home Services Unit Agency for Healthcare Administration revealed that the current LD was approved on 09/27/2022. -Review of the procedure manual showed that the current LD approved, signed and dated the procedure manual on 11/2022. During an interview on 02/15/2023 at 11:45 AM, the supervisor acknowledged that the current LD failed to review, approve and sign procedure manual before use after her designation as LD. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 01/27/2020 found that University of Miami Hospital and Clinics Coral Springs Clinical Laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review of College of American Pathologists (CAP) proficiency testing records and interview with Technical Supervisor (TS), the laboratory failed to score at least 80% on White Blood Cell Identification (WBCI) for 1 (3rd event of 2018) out of 6 events for Hematology specialty reviewed during 2018 and 2019. Findings include: Review of CAP proficiency testing records revealed a score of 0% for WBCI in the 3rd event of 2018. During an interview on 01/27/2020 at 11:30 AM, the TS confirmed the failed proficiency testing score. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --