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 surveyor review of Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) records and interview with the technical supervisor, the laboratory did not evaluate the accuracy for twenty-five of twenty-five "Not scored- insufficient peer group" "WBC Auto Differential" proficiency testing results in 2020. Findings include: 1. Review of WSLH PT records showed the laboratory did not evaluate the accuracy of the following "WBC Auto Differential" proficiency testing results in 2020. a. 2020-HemeReg 1: Five of five "Not scored-insufficient peer group" "Monocytes %" results. b. 2020-HemeReg2: Five of five "Not scored-insufficient peer group" "Lymphocytes %" results and five of five "Not scored-insufficient peer group" "Basophils %" results. c. 2020-HemeReg3: Five of five "Not scored-insufficient peer group" "Neutrophils %" results and five of five "Not scored-insufficient peer group" "Lymphocytes %" results. 2. Interview with the technical supervisor on March 4, 2021 at 10:20 AM confirmed the laboratory did not evaluate the accuracy for twenty- five of twenty-five "Not scored-insufficient peer group" "WBC Auto Differential" PT results in 2020. 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 --