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 - PLANTATION from September 15, 2025 to October 14, 2025. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: 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 three out four TP in 2025. Findings included: 1- Review of FORM CMS 209 signed by the Laboratory Director on 09/15 /2025, revealed the following: Laboratory Director (LD) was also Clinical Consultant. The laboratory had two Technical Consultant (TC#1, TC#2) for Chemistry specialty, and two Technical Supervisor (TS#1, TS#2); TS#2 was also the General Supervisor (GS) for the Hematology specialty. The laboratory had four testing persons (TP#1, TP#2, TP#3 and TP#4). 2-Review of personnel records initial competency for TP#1 for the Stago (9) coagulation and the Sysmex XN-1000, both analyzers in the Hematology specialty, revealed that the competency for patient testing was observed by TP#2 and on 01/06/2025 for Stago (9) and on 01/10/2025 for Sysmex XN-1000. TP#2 had no delegation letter to do competency. 3- Review of personnel records annual competency for TP#3, revealed that the direct observation of patient testing with the Integra 400 in Chemistry specialty and with the for Sysmex XN-1000 in Hematology specialty, was observed by TP#2 on 04/15/2025. TP#2 had no delegation letter to do competency. 4-Review of personnel records six-month competency for 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 -- TP#4 for the Integra 400 in Chemistry specialty, revealed that the competency for patient testing was observed by TP#2 on 06/05/2025. TP#2 had no delegation letter to do competency. 5-During an interview on 09/15/2025 at 11:53 AM, the GS and TP#2 confirmed that TC did not perform the patient testing observation during competency for TP#1 on 01/10/2025 and 01/06/2025, TP#3 on 04/15/2025 and TP#4 on 06/05 /2025. D6050 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(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 Consultant (TC) or a designee failed to do direct observation of performance of instrument and function check during competency evaluation for testing personnel (TP) for three out four TP in 2025. Findings included: 1- Review of FORM CMS 209 signed by the Laboratory Director on 09/15/2025, revealed the following: Laboratory Director (LD) was also Clinical Consultant. The laboratory had two Technical Consultant (TC#1, TC#2) for Chemistry specialty, and two Technical Supervisor (TS#1, TS#2) for Hematology specialty; TS#2 was also the General Supervisor (GS) for the Hematology specialty. The laboratory had four testing persons (TP#1, TP#2, TP#3 and TP#4). 2- Review of personnel records initial competency for TP#1 revealed that the direct observation of performance of instrument and function check for the Stago (9) coagulation and the Sysmex XN-1000 in the Hematology specialty, were observed by TP#2 and on 01/06 /2025 for Stago (9) and on 01/10/2025 for Sysmex XN-1000. TP#2 had no delegation letter to do competency. 3-Review of personnel records annual competency for TP#3, revealed that the direct observation of performance of instrument and function check for the Integra 400 in Chemistry specialty, was observed by TP#2 on 04/15/2025. TP#2 had no delegation letter to do competency. 4- Review of personnel records six- month competency for TP#4, revealed that the direct observation of performance of instrument and function check for Integra 400 for Chemistry specialty was observed by TP#2 on 06/05/2025. TP#2 had no delegation letter to do competency. 5- During an interview on 09/15/2025 at 11:53 AM, the GS and TP#2 confirmed that TC failed to do direct observation of performance of instrument and function check during competency for TP#1 on 01/10/2025 and 01/06/2025, TP#3 on 04/15/2025 and TP4 on 06/05/2025. 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 three testing personnel (TP) out of four in 2025. Findings included: 1-- Review of FORM CMS 209 signed by the Laboratory Director on 09/15/2025, -- 2 of 3 -- revealed the following: Laboratory Director (LD) was also Clinical Consultant. The laboratory had two Technical Consultant (TC#1, TC#2) for Chemistry specialty, and two Technical Supervisor (TS#1, TS#2) for Hematology specialty; TS#2 was also the General Supervisor (GS) for the Hematology specialty. The laboratory had four testing persons (TP#1, TP#2, TP#3 and TP#4). 2-Review of personnel records initial competency for TP#1 revealed that the direct observation of patient testing with the Sysmex XN-1000 in the Hematology specialty, was observed by TP#2 on 01/10/2025. TP#2 had no delegation letter to do competency. 3- Review of personnel records annual competency for TP#3, revealed that the direct observation of patient testing with the Sysmex XN-1000 in Hematology specialty, was observed by TP#2 on 04/15 /2025. TP#2 had no delegation letter to do competency. 4- Review of personnel records six-month competency for TP#4 revealed that the direct observation of patient testing with the Sysmex XN-1000 in Hematology specialty, was observed by TP#2 on 06/05/2025. TP#2 had no delegation letter to do competency. 5- During an interview on 09/15/2025 at 11:53 AM, the TS/GS admitted did not perform the patient testing observation during competency for TP#1 on 01/10/2025, TP#3 on 04/15/2025 and TP#4 on 06/05/2025. 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 designee failed to do direct observation of performance of instrument and function check during competency evaluation for three out of four testing personnel (TP) in 2025. Findings included: 1- - Review of FORM CMS 209 signed by the Laboratory Director on 09/15/2025, revealed the following: Laboratory Director (LD) was also Clinical Consultant. The laboratory had two Technical Consultant (TC#1, TC#2) for Chemistry specialty, and two Technical Supervisor (TS#1, TS#2) for Hematology specialty; TS#2 was also the General Supervisor (GS) for the Hematology specialty. The laboratory had four testing persons (TP#1, TP#2, TP#3 and TP#4). 2-Review of personnel records initial competency for TP#1 revealed that the direct observation of performance of instrument and function check with the Sysmex XN-1000 in the Hematology specialty, was observed by TP#2 on 01/10/2025. TP#2 had no delegation letter to do competency. 3- Review of personnel records annual competency for TP#3, revealed that the direct observation of performance of instrument and function check with the Sysmex XN-1000 in Hematology specialty, was observed by TP#2 on 04/15 /2025. TP#2 had no delegation letter to do competency. 4- Review of personnel records six-month competency for TP#4 revealed that the direct observation of performance of instrument and function check with the Sysmex XN-1000 in Hematology specialty, was observed by TP#2 on 06/05/2025. TP#2 had no delegation letter to do competency. 5- During an interview on 09/15/2025 at 11:53 AM, the TS /GS admitted did not perform direct observation of performance of instrument and function check during competency for TP#1 on 01/10/2025, TP#3 on 04/15/2025 and TP#4 on 06/05/2025. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 12/28/2021 found the UNIVERSITY OF MIAMI HOSPITAL AND CLINICS PLANTATION clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and staff interview, the Laboratory Director (LD) or a designee failed to sign PT attestation statements for 3 out of 6 (2020-2021) testing events reviewed for the specialties of Chemistry and Hematology. Findings include: Review of College of American Pathologists (CAP) PT records showed the LD or designee failed to sign CAP attestation statements attesting to the routine integration of the PT samples into the patient workload using the laboratory's routine methods for the following testing events in 2021: -Chemistry: Event A, Event B and Event C. -Clinical Microscopy: Event A and Event B. - Coagulation: Event A, Event B, Event C. -Hematology: Event A, Event B, Event C. - Peripheral Blood Smears: Event A and Event B. During an interview on 12/28/2021 at 12:30 PM, the laboratory manager confirmed that the laboratory failed to have the LD or designee to sign attestation for the events of reference. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other 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 -- supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, record review and staff interview, the laboratory failed to label controls and calibrator currently in use with the open date and new expiration date. Findings include: - During laboratory tour on 12/28/2021 at 9:30 AM the surveyor observed the following: a) Examination of XN-CHECK hematology controls for the Sysmex XN-100 analyzer level 1, 2 and 3 showed that did not have the new expiration date for the vials currently in use. Review of the package insert for the controls noted " Open vials and vials which have been sampled by cap piercing will retain stability for 7 days if stored at 2-8 degrees Celsius after being re-capped. b) Examination of 2 calibrator vials (A and B) for automated systems (c.f.a.s.) for the Roche Cobas Integra analyzer, stored at -20 degrees Celsius revealed that vial A, had opening date but no new expiration date and vial B had no open and new expiration date. Review of package insert for the calibrator noted " Stability of the components in the reconstitute calibrator at -15 to -25 C 4 weeks (when frozen once)" During an interview on 12/28 /2021 at 12:30 PM, the Testing Personnel A, confirmed that controls in use were missing the label information described above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 01/15/2020 found that the University of Miami Hospital and Clinics Plantation clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 General Supervisor (GS), the laboratory failed to score at least 80 % on Total Protein for 1 (3rd event of 2018) out of 6 events for Routine Chemistry reviewed. Findings include: Review of CAP proficiency records revealed a score of 20 % for Total Protein in the 3rd event of 2018. During an interview on 01/15/2020 at 11:30 AM, the GS 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 --