Summary:
Summary Statement of Deficiencies 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 (PT) records available on 07/22/22, there was no documented verification or review of scores for analytes that received ungraded or "no consensus" PT scores. Findings include: No review or verification was documented for analytes with the following PT scores: 1) Ungraded results on Chemistry Miscellaneous Event 1 in 2022: a. Cystatin (2 samples) 2) Ungraded (no consensus) results on Immunology/Immunohematology Event 1 in 2022: a. CCP (1 sample) 3) Ungraded results on Hematology/Coagulation Event 1 in 2022: a. Sperm Classification (3 samples) b. Sperm Morphology (2 samples) c. Educational Blood Cell Identification--automated (6 samples) d. Educational Blood Cell Identification-- manual (5 samples) e. Educational Platelet Estimate (1 sample) 4) Ungraded results on Hematology/Coagulation Event 3 in 2021 a. Sperm Classification (6 samples) b. Sperm Morphology (2 samples) 5) Ungraded results on Hematology/Coagulation Event 2 in 2021 a. Blood Cell Identification (1 sample) b. Educational Blood Cell Identification--manual (5 samples) c. Educational Platelet Estimate (1 sample) 6) Ungraded results on Hematology/Coagulation Event 1 in 2021 a. Sperm Classification (2 samples) b. Sperm Morphology (1 sample) c. Sperm Count (1 sample) d. Educational Blood Cell Identification-auto (6 samples) e. Educational Platelet Estimate (1 sample) f. Educational Blood Cell Identification-manual (5 samples) g. Urine crystal (1 sample) 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 -- 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 available on 07/22/2022, there was no documented review of all unacceptable PT scores and the