Summary:
Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at Laboratorio Clinico Emanuel on December 8, 2025. 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 December 8, 2025. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e)(5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. This STANDARD is not met as evidenced by: Based on urinalysis quality control records review (years 2024 - 2025), manufacturer's instructions and interview with the laboratory director on December 8, 2025 at 10:30 AM, it was determined that the laboratory did not follow manufacturer's instructions of the optimum temperature required to process urinalysis samples, when they processed and reported 66 urinalysis patients tests from November 19, 2025 to December 5, 2025. The findings include: 1. The laboratory performs urinalysis tests with the Siemens Clinitek Advantus Analyzer. 2. On December 8, 2025 at 10:20 AM the manufacturer's instructions were reviewed, and it establishes on the environmental specifications that the optitmum operating temperature for urinalysis tests was from 22C to 26 C (72F to 79F). It also states that at temperatures under 22C (72F), urobilinogen and leukocyte results may be decreased, and at temperatures above 26C (79F), increased. 3. On December 8, 2025 at 10:25 AM, the quality control records for urinalysis tests were reviewed (years 2024 - 2025), and showed that the laboratory documented temperatures of 20C and 21C when processing urinalysis samples from November 19, 2025 to December 5, 2025. 4. The laboratory director confirmed on December 8, 2025 at 10:30 AM, that the laboratory documented temperatures outside the manufacturer's optimum operating temperature range, when 66 patient specimens 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 -- were processed and reported for urinalysis tests from November 19, 2025 to December 5, 2025. D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) (e) The laboratory director must-- (e)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on urinalysis quality control records review (years 2024 - 2025), manufacturer's instructions and interview with the laboratory director on December 8, 2025 at 10:30 AM, it was determined that the laboratory director failed to monitor urinalysis test specimen examinations to ensure that acceptable levels of analytic performance are mantained for urinalysis tests. Refer to D5479. -- 2 of 2 --