Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at David A Sigalow MD PA on April 8, 2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the proficiency testing (PT) records, and interview, the laboratory failed to verify the accuracy for urine colony counts for 2024. Findings: Review of the College of American Pathologist PT records revealed there was no documentation of PT for 2024. During an interview on 04/08/2024 at 2:00 PM, the Laboratory Director stated the PT renewal email went to the email address of a former employee and they failed to renew the PT for 2024. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --