Laboratorio Clinico Flores

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at Laboratorio Clinico Flores on January 23, 2026. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following condition and standard level deficiencies were found during the recertification CLIA survey ending on January 23, 2026. D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the Mycoplasma pneumoniae IgM quality control records ( year 2025-2026 ) on January 23, 2026 at 10:28 A.M., and laboratory testing personnel interview; it was determined that the laboratory failed to meet the quality control requirements for Mycoplasma pneumoniae IgM test. Refer to D5449. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on the Mycoplasma pneumoniae IgM quality control records review, and testing personnel interview on January 23, 2026 at 10:28 AM, the laboratory failed to include an external negative and positive control material , each day of patient testing. The laboratory processed and reported 222 patient samples from June 30, 2025 to 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 -- January 23, 2026. The findings include: 1. The laboratory uses the Immuno Card Mycoplasma kit to perform the Mycoplasma pneumoniae IgM tests. 2. Review of the Mycoplasma pneumoniae IgM test quality control records on January 23, 2026 at 10: 28 AM, showed that the laboratory did not perform the external negative and positive control material each day of patient testing, when the laboratory processed and reported 222 patient samples from June 30, 2025 to January 23, 2026. 3. The laboratory testing personnel confirmed on January 23, 2026 at 10:33 AM, that the laboratory failed to perform the external negative and positive control material each day of patient testing. The laboratory processed and reported 222 patient samples from June 30, 2025 to January 23, 2026. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on Mycoplasma Pneumoniae IgM quality control records ( year 2025-2026) and interview with the laboratory testing personnel on January 23, 2026 at 10:35 AM, it was determined that the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the laboratory quality control requirements. Refer to D6093. 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 Mycoplasma Pneumoniae IgM quality control records review, and interview with the laboratory testing personnel on January 23, 2026 at 10:33 AM, it was determined that the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the laboratory quality control requirements. Refer to D5449. -- 2 of 2 --

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on General Immunology (COVID-19 IgM/IgG) quality control records, manufacturer instructions for use (IFU) review and interview the laboratory director on January 20, 2022 at 8:36 AM, it was determined that the laboratory did not include an external positive and negative control materials each day of testing when nine out of nine patient's specimens were tested for COVID-19 rapid test from October 1, 2021 to October 15, 2021. The findings include: 1. The laboratory use the Healgen COVID- 19 IgG/IgM Rapid Test Cassette to perform rapid immunology IgM/IgG patient test. 2. The quality control section of the IFU stated that: additional controls may be required according to guidelines or local, state and/or federal regulations (such as 42 CFR 493.1256) or accrediting organizations. 3. Review of COVID-19 IgM/IgG quality control records showed that the laboratory performs patient testing from October 1, 2021 to October 15, 2021, the laboratory did not include every day of testing the positive and the negative control materials. Instead the laboratory run the external controls when a new reagent kit lot or shipment were received. 4. From October 1, 2021 to October 15, 2021 the laboratory processed and reported 9 patient samples. 5. The laboratory director confirmed on January 20, 2022 at 8:36 AM, , that the laboratory failed to include a negative and positive external control materials each day of testing. D6093 LABORATORY DIRECTOR RESPONSIBILITIES 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 -- CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control 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 General Immunology (COVID-19 IgM/IgG) quality control records, manufacturer instructions for use (IFU) review and interview the laboratory director on January 20, 2022 at 8:36 AM, it was determined that the laboratory director failed to establish the quality control procedures for the COVID-19 IgM/IgG test. Refer to D 5449 (The laboratory did not include each day of testing an external positive and negative control material when nine out of nine patient's specimens were tested for COVID-19 rapid test from October 1, 2021 to October 15, 2021). -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of calibration verification records (years 2018 and 2019) for the routine chemistry test and laboratory director interview at 9:50 a.m. on January 14, 2020, it was determined that the laboratory failed to retain records that documenting all the calibration verification procedures of the routine chemistry tests from January 2018 to December 2019. The findings include: 1. The laboratory used the Daytona system to perform the CMP and lipid panel tests. 2. The calibration verification records for the routine chemistry test showed that the laboratory performed the calibration verification procedures for CMP and lipid panel tests on August 20, 2018, April 23, 2019 and November 6, 2019. However, the laboratory did not retained the system print out nor the inserts of the calibrator used for those dates (calibrators name, lots numbers and expiration date). 3. The laboratory director confirmed at 9:50 a.m. on January 14, 2020, that the laboratory did not have those records available. 4. The laboratory reported 106,998 out of 106,998 routine chemistry tests from January 2018 to December 2019 by the Daytona system. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) 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 -- -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of calibration verification records (years 2018 and 2019) for routine chemistry test and laboratory director interview at 9:50 a.m. on January 14, 2020, it was determined that the laboratory failed to perform at least every 6 months the calibration verification procedures for the routine chemistry test (comprehensive metabolic panel (CMP) and lipid panel) when the laboratory processed patients specimens and reported 106,998 out of 106,998 routine chemistry tests from January 2018 to December 2019 by the Daytona system. The findings include: 1. The laboratory used the Daytona system to perform the CMP and lipid panel tests. 2. The calibration verification records showed that the laboratory did not perform at least every 6 months the calibration verification procedures for CMP and lipid panel tests from January 2018 to December 2019 . The records showed that the laboratory performed the calibration verification procedures on August 20, 2018, April 23, 2019 and November 6, 2019. 3. The laboratory director confirmed at 9:50 a.m. on January 14, 2020, the documentation of the calibration verification records. She stated that the laboratory performed a second procedures during the year 2018 but she can not found this documentation. 4. The laboratory reported 106,998 out of 106,998 routine chemistry tests from January 2018 to December 2019 by the Daytona system. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of calibration verification records (years 2018 and 2019) for the -- 2 of 3 -- routine chemistry test and laboratory director interview at 9:50 a.m. on January 14, 2020, it was determined that the laboratory director failed to fulfill her responsibilities and duties to comply with the laboratory retention requirements. Refer to D 3031 (The laboratory failed to retain records that documenting all the calibration verification procedures of the routine chemistry tests from January 2018 to December 2019). D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control 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 calibration verification records (years 2018 and 2019) for routine chemistry test and laboratory director interview at 9:50 a.m. on January 14, 2020, it was determined that the laboratory director failed to comply with the analytic requirements for the routine chemistry tests. Refer to D 5439 (The laboratory failed to perform at least every 6 months the calibration verification procedures for the routine chemistry test (comprehensive metabolic panel (CMP) and lipid panel) when the laboratory processed patients specimens and reported 106,998 out of 106,998 routine chemistry tests from January 2018 to December 2019 by the Daytona system). -- 3 of 3 --