Sincera Health Pllc

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) (a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and confirmed by laboratory director identifier #1 (LD#1) at 9:40 am on 7/13/2026, the laboratory failed to retain the proficiency testing attestation statements for four out of four proficiency testing events from 1/1/2025 - 7/13/2026. The findings include: 1. The laboratory did not have attestation statements for the following events: *2026 event 1 - microbiology and hematology/coagulation *2025 event 3 - microbiology *2025 event 2 - microbiology and hematology/coagulation *2025 event 1- microbiology 2. At the time of the survey, LD #1 confirmed the laboratory failed to retain to above attestation statements. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of proficiency testing records and confirmed by interview with Laboratory Director identifier #1 (LD #1) at 9:40 am on 7/13/2026, the laboratory 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 -- failed to perform a self evaluation when the laboratory received an ungraded PT score from one out of four testing events from 01/01/2025- 7/13/2026. The findings include: 1. For 2026 event 1, the laboratory received an ungraded PT score for QIAstat Enterovirus specimen RSP-04. 2. At the time of the survey, LD #1 confirmed the laboratory did not perform a self evaluation for the ungraded PT test score listed above. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by interview with Laboratory Director identifier #1 (LD #1) at 9:40 am on 7/13/2026, the laboratory failed to take and document

Summary Statement of Deficiencies D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the laboratories policies and procedures, quality control (QC) records, verification of performance specification records, patient specimen logs, and confirmed by interview with the Laboratory Director (LD), the laboratory failed to: have procedures as specified in D5403; ensure approval of laboratory procedures with a date and signature by the LD as specified in D5407; verify the performance specifications of accuracy and precision for human immunodeficiency virus (HIV) 1/2 antigen/antibody testing as specified in D5421; perform two levels of QC at least once each day of patient testing as specified in D5449; ensure QC results meet the laboratory's criteria for acceptability before reporting patient test results as specified in D5481; take and document