Summary:
Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 11/18/20 at Joshua & Joshua Md Pa, a clinical laboratory in Lake Worth, Florida. Joshua & Joshua Md Pa is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. The following is a description of the noncompliance. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the laboratory director had not always signed the attestation statement for proficiency testing. The findings included: Review of proficiency testing records for the past two years on 11 /18/2020 revealed that for the first hematology testing event of 2020, the Director had not signed the attestation statement. During an interview with testing person A on 11 /18/20 at 10:50 a.m., she confirmed that the form was not signed by the Director. 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 --