Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at SOLLIS HEALTH FLORIDA INC from 03/16/2026 to 03/30/3036. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) (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 records review and staff interview, the laboratory failed to achieve satisfactory performance for the Potassium (K) analyte in the Chemistry specialty for one out of one event reviewed (2026). Findings include: 1-Review of American Proficiency Institute (API) records for Routine Chemistry 2026 (1st event) revealed the following failing score: -1st event 2026: K analyte the laboratory received a 0% score (unsatisfactory analyte performance). 2-During an interview on 03/16/2026 at 11:20 AM, Testing Personnel # 1 confirmed the unsatisfactory analyte performance for K in Routine Chemistry. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)