Summary:
Summary Statement of Deficiencies D5020 ENDOCRINOLOGY CFR(s): 493.1212 If the laboratory provides services in the subspecialty of Endocrinology, 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 surveyor review of the Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to ensure that quality systems for the preanalytic and analytic phases of Endocrinology testing were monitored from June 2016 to the date of the survey. 1. The laboratory did not verify the accuracy of the Roche Cobas e411 analyzer before putting it into use. Cross Refer D 5421 2. The laboratory failed to establish written procedures to monitor and assess Quality Control (QC) for Endocrinology tests performed on the Roche Cobas e411 analyzer. Cross refer D 5791. 3. The laboratory failed to identify the source of the Reference Intervals (RI) used for endocrinology. Cross refer D 5807 4. The laboratory did not review and evaluate trends and/or shifts. Cross refer D 6074 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 surveyor review of Proficiency Testing (PT) results and interview with the Testing Personnel (TP), the laboratory failed to evaluate results when the laboratory received a grade of 50% for Andrology / Embryo Grading / Embryology / Fetal Fibronectin / Fetal Membrane Rupture test performed with the American Association Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- of Bioanalysts (AAB) in 2017. The findings include: 1. The laboratory received a grade of 50% in the AAB 1st ship 2017 for Sperm Motility. 2. The laboratory received a grade of 50% in the AAB 1st ship 2017 for forward progression. 3. No evaluation was documented for any of the unacceptable analyte scores mentioned above. 5. The TP #1 listed on CMS form 209 confirmed on 6/19/18 at 2:00 pm that the laboratory did not perform and document