Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Medical Specialists of Ft Lauderdale PA on 07/31/19. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of College of American Pathologist (CAP) proficiency testing and interview with the Office Manager, the laboratory failed to score at least 80% on Hematocrit the 2nd testing event in 2018. Findings Included: Review of CAP proficiency testing for the 2nd testing event in 2018 revealed a score of 20% for Hematocrit. During an interview on 07/31/19 at 12:30 PM the Office Manager confirmed the failure of Hematocrit. 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, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with the Office Manager, the laboratory failed to perform competency evaluations of 1 (#A) out of 3 (#A, #B, and #C) Testing 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 -- People for 2 out of 2 years (2017-2019) reviewed. Findings Included: Review of personnel filed revealed that Testing Person #A did not have any competency evaluations. During an interview on 07/31/19 at 12:30 PM the Office Manager confirmed that no competency evaluations had been performed on Testing Person #A. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of College of American Pathologist (CAP) proficiency testing and interview with the Office Manger, the laboratory failed to have