Unilab Of Dade Inc

Summary Statement of Deficiencies D0000 An announced CLIA validation survey was conducted at UNILAB OF DADE INC from 03/05/2025 to 03/11/2025. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. The laboratory was found out of compliance with the following conditions: -D6033 CFR 493.1409 Technical Consultant. -D6076 CFR 493.1441 Laboratory Director. 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 review of laboratory's record and interview with laboratory General Supervisor (GS), the laboratory failed to perform competency evaluation for 2023 for one out of six testing personnel (TP) listed on the FORM CMS-209. Findings included: 1-Review of the annual competency assessment records revealed no competency performed in 2023 for (TP#6) of the testing persons listed in the FORM CMS-209 Laboratory Personnel Report, signed by the Laboratory Director on 02/28 /2025. 2- Review of Laboratory records revealed no

Summary Statement of Deficiencies D0000 A recertification survey conducted on 1-8-2020, found the Unilab of Dade Inc clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to receive a passing score of 80 % for the chemistry analyte Human Chronic Gonadotropin (HCG) for the 1st proficiency testing (PT) in January 24, 2018. Findings Include: A review of CMS Casper Report record displayed that the laboratory received a 40% for HCG. A review of 2018 American Proficiency Institute (API) record stated a 40% was received for HCG chemistry analyte for the 1st PT event in January. During an interview on 1-8 -2020 at 12:30 pm , the general supervisor confirmed that the laboratory had received a 40% for HCG in the first PT event of 2018. 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 --

Summary Statement of Deficiencies D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on personnel records review and interview with laboratory owner, the laboratory failed to do annual competency evaluations for general supervisor 2 out of 2 from 2016 and 2017. Findings include: Personnel records for 2016 and 2017 showed the laboratory no documented annual competencies for General Supervisor On 01/25 /2018 at 10:30 am, the laboratory owner confirmed that the laboratory did not document annual competencies for the general supervisor for 2016 and 2017. 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 --