Laboratorio Clinico Cuba

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on May 14, 2026 to Laboratorio Clnico Cuba, the laboratory was found out of compliance with the following conditions: 42 CFR 493.803 Proficiency Testing, Successful Participation 42 CFR 493.1403 Laboratory Director, moderate complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of Certification And Survey Provider Enhanced Reports (CASPER) 0155D and Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2025-2026), the laboratory failed to achieve satisfactory performance (80% or better) 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 -- for two (2) out of two (2) consecutive testing events for the subspecialty of routine chemistry in the analyte Albumin tests. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of Certification And Survey Provider Enhanced Reports (CASPER) 0155D and Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2025-2026), the laboratory failed to achieve satisfactory performance (80% or better) for two (2) out of two (2) consecutive testing events for the subspecialty of routine chemistry in the analyte Albumin tests. The findings include: 1. Review of the Casper Report 0155D and PRPTSP scores on May 10, 2026, confirmed that the laboratory had a PT (Proficiency Test) failure for the analyte Albumin tests in the subspecialty of routine chemistry. The laboratory obtained the following testing scores: Analyte: Albumin a. Third testing event year 2025 - 60% b. First testing event year 2025 - 60% 2. A review of the PRPTSP records confirmed the above findings. 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 review of Certification And Survey Provider Enhanced Reports (CASPER) 0155D and Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2025-2026), the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure proficiency testing samples were tested as required. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of Certification And Survey Provider Enhanced Reports (CASPER) 0155D and Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2025-2026), the laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA Recertification survey at the Laboratorio Clnico Cuba on January 14, 2026. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The following standard level deficiencies were found during the unannounced routine CLIA recertification survey ending on January 14, 2026. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the ImmunoCard Mycoplasma pneumoniae manufacturer's instructions, Mycoplasma pneumoniae testing records (year 2025), and interview with the general supervisor on January 14, 2026, at 11:15 a.m., the laboratory failed to follow the manufacturer's instructions regarding the established temperature range for Mycoplasma pneumoniae testing when the laboratory processed and reported 60 of 394 patient specimens outside the manufacturer's required temperature range from January 2, 2025, through December 31, 2025. Findings include: 1. The laboratory used the ImmunoCard Mycoplasma pneumoniae qualitative test to perform Mycoplasma pneumoniae testing. 2. Review of the manufacturer's instructions established a required temperature range of 22C to 25C for test procedures. 3. Review 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 -- of Mycoplasma pneumoniae testing records showed that from January 2, 2025, through December 31, 2025, the laboratory processed and reported 60 of 394 patient specimens at a temperature of 21C, which was below the manufacturer's required temperature range. 4. During interview on January 14, 2026, at 11:15 a.m., the general supervisor confirmed that the laboratory processed patient specimens outside the manufacturer's established temperature range. 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 review of the Mycoplasma pneumoniae manufacturer's instructions, Mycoplasma pneumoniae testing records (year 2025), and interview with the general supervisor on January 14, 2026, at 12:00 p.m., the laboratory director failed to ensure that the manufacturer's instructions regarding the established temperature range for Mycoplasma pneumoniae testing were followed by the general supervisor, the laboratory processed and reported 60 of 394 patient specimens outside the manufacturer's required temperature range. Refer to D5413. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on review of the Mycoplasma pneumoniae manufacturer's instructions, Mycoplasma pneumoniae testing records (year 2025), and interview with the laboratory general supervisor on January 14, 2026, at 12:00 p.m., the laboratory general supervisor failed to ensure that the manufacturer's instructions regarding the established temperature range for Mycoplasma pneumoniae testing were followed by testing personnel. Refer to D5413. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The Laboratorio Clnico Cuba was found to be in substantial compliance with CLIA regulation (42 CFR Part 493, effective April 24, 2003). No deficiencies were cited as a result of an onsite survey performed on February 13, 2020. 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 --