Summary:
Summary Statement of Deficiencies 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 surveyor review of the Proficiency Testing (PT) records, and interview with the Testing Personnel (TP), the laboratory failed to maintain "Semen Analysis Report" for proficiency samples for the 1st and 2nd event in 2017 and the 1st event of 2018. The TP #1 listed on CMS form 209 confirmed on 7/31/18 at 10:00 AM that "Semen Analysis Report" records were not maintained for the aforementioned PT events. This deficiency was previously cited on the survey dated 7/26/2016. The