Summary:
Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at Laboratorio Clinico Lorimar on June 24, 2026. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following standard level deficiencies were found during the recertification CLIA survey ending on June 24, 2026. 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: A. Based on personnel records review (years 2025-2026), written policies for personnel competence procedures and laboratory technical consultant interview on June 24, 2026, at 9:30 AM, it was determined that the laboratory failed to have written policies to assess the technical consultant competence. The findings include: 1. The technical consultant personnel records were reviewed since June 2024. 2.The laboratory written policies for personnel competence procedures showed that testing personnel competence procedures performed annually. 3. The laboratory technical consultant confirmed on June 24, 2026, at 9:30 AM, that the laboratory director failed to perform the annual competence evaluation to the technical consultant since June 2024. B. Based on personnel records review (year 2025-2026) and laboratory technical consultant interview on June 24, 2026, at 9:30 AM, it was determined that the laboratory failed to follow the established schedule for competence evaluation for the clinical consultant. The finding includes: 1. The laboratory written policy for personnel competence procedures showed that competence procedures perform annually. 2. The personal records review, on June 24, 2026 at 9:40 AM, showed that the last competence evaluation for the clinical consultant a was performed on 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 -- February 2025. 3. The laboratory technical consultant confirmed on June 24, 2026 at 9:45 AM, that the competence evaluation for the clinical consultant was not performed as established (annually) in year 2026. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on personnel records review (years 2024-2026) and laboratory technical consultant interview on June 24, 2026 at 9:30 AM, it was determined that the laboratory director failed to follow the established schedule to monitor and ensure the competency evaluation of the laboratory clinical consultant and failed to have written policies to assess the technical consultant competence. Refer to D5209. -- 2 of 2 --