Blue Sky Fertility

Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of quality control (QC) records, manufacturer's instructions, laboratory procedure, and technical supervisor (TS) interview, the laboratory failed to obtain and/or document QC results that met the laboratory's and manufacturer's criteria for acceptability before reporting patient test results for semen analysis. Findings: 1. Review of "Daily Quality Control Log" entries for the year 2023 revealed under: Stain Change: a.. No documentation of acceptable stain quality was provided in this section. b.. No documentation of acceptable stain quality was provided at the time of survey for the year 2023. 2. Review of the SCOPESCREEN QC-Beads instructions revealed the following expected values using the Micro-Cell counting chamber: a. Hi QC-Beads 30-40 million beads/ml. b. Lo QC-Beads 15-21 million beads/ml. 3. Review of "Daily Quality Control Log" entries for the year 2023 revealed under: Accubead Check: a. All entries were "yes." b. No documentation of obtained QC values was provided at the time of survey. c. No documentation of repeat testing,

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on the lack of documentation and interview, the laboratory failed to define a function check protocol to verify the accuracy of the timer and speed of the laboratory centrifuges, the volume accuracy of the pipettes, and the temperature accuracy of the thermometers. Findings: 1. No documentation was provided at the time of survey to show the laboratory defined a function check protocol to verify the accuracy of the timer and speed mechanisms on centrifuges. No documentation was provided at the time of survey to demonstrate the time or speed for 2 of 2 centrifuges had been tested since September 2018 2. Inspection of the calibrated pipettes used to perform sample aliquots and dilutions showed no markings for accuracy checks. No documentation was provided at the time of survey to demonstrate that 2 of 2 pipettes had their volume accuracy verfied since September 2018. 3. No documentation was provided at the time of survey to show the laboratory defined a function check protocol to verify the accuracy of the thermometers. No documentation was available for the certification of accuracy (NIST traceble) for 2 of 2 thermometers. 4. Interview with technical supervisor #1 on 09/11/2020 @10:15 a.m. confirmed, the laboratory failed Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- to define a function check protocol to verify the accuracy of the timer and speed of the laboratory centrifuges, the volume accuracy of the pipettes, and the temperature accuracy of the thermometers. -- 2 of 2 --