Laboratorio Clinico Aquarium

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at Laboratorio Clinico Aquarium on September 3, 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 September 3, 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 general supervisor on September 3, 2025 at 11:03 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 7363 urinalysis patients tests from January 1, 2024 to September 3, 2025. The findings include: 1. The laboratory performs urinalysis tests with the Siemens Clinitek Advantus Analyzer. 2. On September 3, 2025 at 10:54 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 September 3, 2025 at 10:58 AM, the quality control records for urinalysis tests were reviewed (years 2024 - 2025), and showed that the laboratory did not document the temperature when processing urinalysis samples from January 1, 2024 to September 3, 2025. 4. The laboratory general supervisor confirmed on September 3, 2025 at 11:03 AM, that the laboratory did not document the temperature 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 -- when processing urinalysis samples, when 7363 patient specimens were processed and reported for urinalysis tests from January 1, 2024 to September 3, 2025. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; 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 general supervisor on September 3, 2025 at 11:03 AM.; it was determined that the laboratory director did not assure that the laboratory follows the manufacturer's instructions. Refer to D5479. D6148 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463(a)(4) (a)(4) Is responsible for monitoring test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained. 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 general supervisor (also testing personnel), on September 3, 2025 at 11:03 AM, it was determined that the laboratory general supervisor 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 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on lack of Proficiency testing record , bacteriology patient records review and general supervisor interview on January 24, 2018 at 9:10 AM, it was determined that the laboratory failed to enroll in an HHS approved Proficiency Testing Program for the following bacteriology tests results : urine no growth cultures and urine colony count tests (Non-waived method) when 5 out of 5 patients urine cultures were processed and reported from January 20, 2018 to January 22, 2018. The findings include: 1. The laboratory did not have records of Proficiency testing results for the following bacteriology tests results : urine no growth cultures and urine colony count tests (Non-waived method) since January 20, 2018. 2. The general supervisor confirmed on January 24, 2018 at 9:15 AM, that the laboratory did not enroll nor participate in an HHS approved Proficiency Testing Program for those tests since January 20, 2018. She stated that the laboratory establishes a comparison protocol to verify twice a year those tests. 3. The laboratory processed and reported 5 out of 5 patients urine cultures patients specimens for urine no growth cultures results and urine colony count tests from January 20, 2018 to January 22, 2018: patient specimen # 1173525 and patient specimen #1173492 on January 20, 2018 and patient specimen 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 -- # 1193002 , patient specimen # 1193001 and patient specimen # 1193024 on January 22, 2018. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on lack of Proficiency testing record , bacteriology patient records review and general supervisor interview on January 24, 2018 at 9:10 AM, it was determined that the laboratory director failed to ensure that the it is enrolled in an HHS approved proficiency testing program for the following bacteriology tests results : urine no growth cultures and urine colony count tests (Non-waived method) from January 20, 2018 to January 22, 2018. The finding includes: 1. The laboratory director did not comply with the requirement of Proficiency testing for the following bacteriology tests results : urine no growth cultures and urine colony count tests (Non-waived method) from January 20, 2018 to January 22, 2018. Refer to D 6015. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on lack of Proficiency testing record , bacteriology patient records review and general supervisor interview on January 24, 2018 at 9:10 AM, it was determined that the laboratory director failed to ensure that the it is enrolled in an HHS approved proficiency testing program for the following bacteriology tests results : urine no growth cultures and urine colony count tests (Non-waived method) from January 20, 2018 to January 22, 2018. Refer to D2000. ( The laboratory processed and reported patients specimens for the following bacteriology tests results : urine no growth cultures and urine colony count tests (Non-waived method) from January 20, 2018 to January 22, 2018. However, the laboratory was not enrolled in an HHS-approved proficiency testing program for those tests. -- 2 of 2 --