Summary:
Summary Statement of Deficiencies D0000 An Initial Survey was initiated on 08/29/2023 and concluded on 08/29/2023. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) In addition, the laboratory must retain records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based on document review, observation, and interviews, the laboratory failed to retain installation and implementation documents for 1 new Sperm Class Analyzer (SCA) installed in August 2021. Findings included: A review of the laboratory's "SCA Installation Guide" indicated that microscope and system calibration were required for installation verification. During the laboratory tour on 08/29/2023 at 9:45 AM, an SCA instrument was observed in the laboratory. During an interview on 08/29/2023 at 9:50 AM, the Laboratory Director (LD) stated the SCA instrument was installed in August 2021. During an interview on 08/29/2023 at 1:06 PM, the LD stated he could not locate the installation records for the SCA instrument. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: 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 -- Based on laboratory policy review, document review, and interviews, the laboratory failed to ensure laboratory procedures were reviewed, approved, and signed by the laboratory director for 1 (2021) of 3 years reviewed. Findings included: A review of a laboratory policy titled, "Policy Manual Approval/Document Control" indicated, "All lab policies and procedures are outlined in written manuals. These policies are reviewed and approved by the laboratory director prior to acceptance. They are reviewed on an annual basis." The Laboratory Director (LD) reviewed and signed the policy manual on 07/12/2018. In an interview on 08/29/2023 at 9:50 AM, the LD stated that the laboratory began testing in August 2021. There was no documentation available for review to indicate that laboratory policies in the policy manual were reviewed and signed by the LD annually for 2021. In an interview on 08/29/2023 at 11:57 AM, the LD stated that the signatures indicating the LD's annual review of the policy manual for 2021 were unable to be located. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on observation, interviews, and document review, the laboratory failed to evaluate the results of sperm counts performed by different methodologies twice a year for 2 (2021 and 2022) of 3 years reviewed. Findings included: During the laboratory tour on 08/29/2023 at 9:45 AM, a Sperm Class Analyzer (SCA) microscopic visualizer was observed in the laboratory. The analyzer performed automated sperm counts on all semen specimens. Makler stainers for manual sperm counts were also observed in the laboratory. During an interview on 08/29/2023 at 9: 50 AM, the Laboratory Director (LD) stated manual and automated sperm counts were performed in the laboratory on patient specimens. A review of a laboratory test policy titled, "Semen Analysis (SA), " revised in December 2015, revealed the laboratory retained procedures for more than one test methodology for sperm counts, automated and manual. There was no documentation available for review to indicate the automated and manual differential methodologies were compared twice a year in 2021 or 2022. During an interview on 08/29/2023 at 1:06 PM, the LD confirmed that twice-a-year comparisons between the automated differentials and manual sperm counts were not performed. -- 2 of 2 --