Summary:
Summary Statement of Deficiencies D0000 An initial certification survey conducted at Boca Biolistics LlC clinical laboratory on 11/01/2019 found the laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of CMS 209 Laboratory Personnel form, review of College of American Pathologists (CAP) proficiency testing (PT) records and interview with General Supervisor (GS), the laboratory failed to have all testing personnel (TP) rotate through the testing of PT for the Bacteriology and Diagnostic Immunology specialties for 1 out of 1 year (2019) reviewed. Findings include: 1-Review of CMS 209 form signed and dated by the Laboratory Director (LD) on 10/30/2019 had 2 testing personnel listed (TPA and TP B). 2-Review of employee folders revealed the following initial evaluation dates TP A on 9/28/2018 TP B on 9/28/2018 3-Review of CAP PT records for 2019, revealed the following: - for TP A, there was no documentation of PT testing in Bacteriology and Immunology Specialties for 2019. During an interview on 11/01/2019 at 12:00 PM, GS confirmed that TP A missed to participate in PT during the year of reference in the specialties listed above. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, 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 -- consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the laboratory did not have a written policy in place for assessing employee competency and failed to perform the 6 months competency assessment for 2 out of 2 testing personnel (TP) (TP A and TP B). Findings include: -Review of procedure manual on 11/1/2019, revealed that there was no written policy for competency assessment of employee competency. - Review of personnel files revealed that there was no documentation of the semiannual competency assessment for TP A and TP B During an interview on 11 /01/2019 at 12:00 PM, with GS, he confirmed that there was no documentation of the competency assessment for the TP listed above for the period of reference. -- 2 of 2 --