Summary:
Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on request and the lack of documentation and monitoring for the room temperatures, and interview with the technical consultant, (9/12/2018, 1630), it was determined that the laboratory failed to retain room temperature records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. See D 5413. 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 second quarter (Q2-2016) of the American Association of Bioanalysts (AAB) proficiency testing records, laboratory's proficiency testing evaluation report, and interview with the technical consultant (9/12/2018, 1630), it was determined that the laboratory failed to verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect 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 -- laboratory test performance. The findings included: Forward Progression: a. Q2-2016, AAB reported an artificial 100% for Makler Forward Progression. Value Grading Reported Range Spec 1? 85 36-60 Spec 2? 40 0-24 AAB's footnote? = This score may not truly evaluate performance for this specimen which was not graded because of a lack of participant consensus. b. The laboratory's true proficiency testing score for Forward Progression should have been 0%. The laboratory lacks the documentation of any