Summary:
Summary Statement of Deficiencies D0000 At the time of the announced, on-site recertification survey, Super Male Mens Clinic, was found to not be in compliance with the CLIA laboratory requirements of 42 CFR 493. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of API (American Proficiency Institute) proficiency testing records and staff interview, the laboratory failed to retain proficiency testing records for 2 testing events in 2022. The findings include: Review of API proficiency testing records for the 1st Event in 2022 and 3rd Event in 2022 showed there was no raw data printouts kept from the Tosoh analyzer used for PSA (prostate-specific antigen), testosterone, and estradiol patient testing. During an interview on 11/8/23 at 11:00 AM, Testing Person A confirmed that the proficiency testing records were missing. D5781