Laboratorio Clinico Dr Cordova

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA Recertification survey at the Laboratorio Clnico Dr Cordova on September 4, 2025. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. During a recertification survey on September 4, 2025, the laboratory was found out of compliance with the following conditions: 42 CFR 493.1208 Condition: General immunology 42 CFR 493.1210 Condition: Routine chemistry 42 CFR 493.1250 Condition: Analytic Systems 42 CFR 493.1441 Condition: Laboratories performing high complexity testing; laboratory director In addition, the laboratory was found out of compliance with the following standard level deficiencies found during the recertification CLIA survey on September 4, 2025. 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 Mycoplasma pneumoniae quality control records patient records review (years 2024-2025) and interview with the laboratory technical supervisor on September 4, 2025, at 11:52 AM, it was determined that the laboratory failed to meet the requirements in the subspecialty of General Immunology. Refer to: D5449 and D5413. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on routine chemistry quality control records review (years 2024-2025) and interview with the laboratory technical supervisor on September 4, 2025, at 10:25 AM, it was determined that the laboratory failed to ensure compliance with the analytic system requirements for routine chemistry test. Refer to D5439. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on quality control records review, manufacturer's instructions review, and laboratory technical supervisor interview on September 4, 2025 at 12:325 PM, it was determined that the laboratory failed to follow the analytic system requirements. Refer to 5014, D5016 and D5024 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 Mycoplasma Pneumoniae IgM test quality control records review, manufacturer's instructions review, and laboratory supervisor interview on September 4, 2025 at 11:52 AM, it was determined that the laboratory failed to monitor and document the room temperature, when 23 patient specimens were processed and reported for Mycoplasma pneumoniae IgM test in the following days: June 18, 2024; June 21, 2024; June 24, 2024; June 25, 2024; June 28, 2024; July 1, 2024; July 2, 2024; July 11, 2024; July 12, 2024; July 15, 2024. The findings include: 1. The laboratory uses the Immuno Card Mycoplasma kit to perform the Mycoplasma pneumoniae IgM tests. 2. On September 4, 2025 at 11:45 AM the manufacturer's instructions were reviewed, and it establishes to perform the test procedures at room temperature from 22 to 25 C. 3. On September 4, 2025 at 11:42 AM, review of the Mycoplasma pneumoniae IgM quality control records showed that the laboratory did not monitor nor document the room temperature when patient's specimens were tested -- 2 of 6 -- for Mycoplasma pneumoniae IgM in the following days: June 18, 2024; June 21, 2024; June 24, 2024; June 25, 2024; June 28, 2024; July 1, 2024; July 2, 2024; July 11, 2024; July 12, 2024; July 15, 2024. 4. The laboratory supervisor confirmed on September 4, 2025 at 11:42 AM, that the laboratory did not monitor nor document the room temperature when they processed the patient's specimens for Mycoplasma pneumoniae IgM test. The laboratory processed and reported 23 patient samples for Mycoplasma pneumoniae IgM in the following days: June 18, 2024; June 21, 2024; June 24, 2024; June 25, 2024; June 28, 2024; July 1, 2024; July 2, 2024; July 11, 2024; July 12, 2024; July 15, 2024. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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)-- (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 routine chemistry calibration verification records review (years 2024-2025) and interview with the laboratory director on September 4, 2025, at 10:25 AM, it was determined that the laboratory did not perform, at least every six months, the calibration verification procedures for sodium (Na+), potassium (K+), and chloride (Cl-) tests, when processed and reported 2,716 out of 2,716 electrolytes patient's test from August 2024, to August 2025. The findings include: 1. The laboratory used the Ortho Vitros 250 Chemistry Analyzer to perform Na+, K+, and Cl- tests. (Reviewed on September 4, 2025, at 10:07 AM) 2. The laboratory performed Na+, K+, and Cl- calibration verification procedures in February 2024 and August 2025. (Reviewed on September 4, 2025, at 10:10 AM) 3. Review of routine chemistry calibration verification records showed that the laboratory did not perform Na+, K+, and Cl- calibration verification procedure in August 2024 and February 2025. (Reviewed on September 4, 2025, at 10:10 AM) 4. The laboratory supervisor confirmed on September 4, 2025, at 10:25 AM, that the laboratory failed to perform, at least every 6 months, the calibration verification procedures for Na+, K+, and Cl- tests. The laboratory processed and reported 2,716 out of 2,716 electrolytes patient's test from August 2024, to August 2025. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) -- 3 of 6 -- (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 reviewed, manufacturer instructions and laboratory supervisor interview on September 4, 2025 at 11:52 A.M., it was determined that the laboratory did not perform the external negative and positive control material in the following days: June 18, 2024; June 21, 2024; June 24, 2024; June 25, 2024; June 28, 2024; July 1, 2024; July 2, 2024; July 11, 2024; July 12, 2024; July 15, 2024. The findings include: 1. Review of the Mycoplasma pneumoniae IgM quality control records on September 4, 2025 at 11:45 A.M, showed that the laboratory did not perform the external negative and positive control material each day of patient testing. 3. The laboratory supervisor confirmed on September 4, 2025 at 11:52 A.M., that the laboratory failed to perform the negative and positive external control material in the following days: June 18, 2024; June 21, 2024; June 24, 2024; June 25, 2024; June 28, 2024; July 1, 2024; July 2, 2024; July 11, 2024; July 12, 2024; July 15, 2024. The laboratory processed and reported 23 patient samples. 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 Routine chemistry, Hematology, Mycoplasma Pneumoniae IgM quality control records, manufacturer's instructions, and interview with the laboratory supervisor on September 4, 2025 at 12:30 PM, 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 and D6095. 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 Routine chemistry, Hematology, Mycoplasma Pneumoniae IgM quality control records, manufacturer's instructions, and interview with the laboratory supervisor on September 4, 2025 at 12:30 PM, it was determined that the laboratory director failed to fulfill to ensure the compliance with the manufacturer's instructions and laboratory quality control requirements. Refer to D5413 and D5449. D6095 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(6) (e)(6) Ensure the establishment and maintenance of acceptable levels of analytical -- 4 of 6 -- performance for each test system; This STANDARD is not met as evidenced by: Based on Mycoplasma Pneumoniae IgM test quality control records review, manufacturer's instructions review, and laboratory supervisor interview on September 4, 2025 at 11:52 AM, it was determined that the laboratory director failed to ensure that the established quality control program was followed and failed to ensure that the laboratory monitored and documented the room temperature, when 23 patient specimens were processed and reported for Mycoplasma pneumoniae IgM test in the following days: June 18, 2024; June 21, 2024; June 24, 2024; June 25, 2024; June 28, 2024; July 1, 2024; July 2, 2024; July 11, 2024; July 12, 2024; July 15, 2024. Refer to D5413 and D5449. D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) (b)(2) Verification of the test procedures performed and establishment of the laboratorys test performance characteristics, including the precision and accuracy of each test and test system; This STANDARD is not met as evidenced by: Based on review of the hematology DxH 520 instrument performance verification results and laboratory technical supervisor interview on September 4, 2025 at 11:18 AM, it was determined that the laboratory technical supervisor failed to evaluate the instrument's obtained results. The laboratory processed and reported 1,698 since the performance verification on December 15, 2023 The findings include: 1. On September 4, 2025 at 11:02 AM; review of the Beckman Coulter Installation Work Order Report showed, that the laboratory installed the DxH 520 hematology system on December 15, 2023. 2. On September 4, 2025 at 11:02 AM, review of the DxH 520 instrument performance verification results did not reflect the evaluation and signature of the laboratory technical supervisor prior to begin to test Complete Blood Count (CBC) patient samples. 3. The laboratory technical supervisor confirmed on September 4, 2025 at 11:02 AM, that the laboratory director did not evaluate and sign the performance verification of the DxH 520 hematology system. 4. The laboratory processed and reported 1,698 CBC tests on the DxH 520 hematology system from December 15, 2023 to September 4, 2025. D6117 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(4) (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: A. Based on the Mycoplasma pneumoniae IgM quality control records reviewed, manufacturer instructions and laboratory technical supervisor interview on September 4, 2025 at 11:52 A.M., it was determined that the laboratory technical supervisor did -- 5 of 6 -- not ensure that the quality control establish were followed. Refer to D5413 and D5449. B. Based on Routine chemistry quality control records review and interview with the laboratory technical supervisor on September 4, 2025 at 12:25 PM, it was determined that the laboratory technical supervisor failed to ensure that the calibration verification of routine chemistry specialty were followed. Refer to D5439. -- 6 of 6 --

Summary Statement of Deficiencies D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on endocrinology quality control records review (years 2017-2019) and laboratory director interview at 9:30 AM on July 26, 2019, it was determined that the laboratory did not evaluate the new reagents lots of hCG qualitative (human chorionic gonadotropin) test for positive and negative reactivity prior to placed it in routine use. The findings include: 1. The laboratory endocrinology quality control records were reviewed from August 2017 to July 26, 2019. 2. The laboratory uses Aim Step Combo hCG to perform hCG qualitative (human chorionic gonadotropin) patient's samples test. 3. The laboratory received the following reagent kit lots and no evaluation of their reactivity was performed: Lot Expiration Date 70522 6/30/19 71222 10/31/19 72862 12/31/19 80332 5/31/20 4. The laboratory processed and reported one hundred thirty one (131) ) hCG qualitative (human chorionic gonadotropin) patient's samples from March 5, 2018 to July 26, 2019. 5. The laboratory director confirmed on July 26, 2019 at 9:30 AM that the laboratory received the hCG qualitative (human chorionic gonadotropin) reagent kit lots by Aim Step Combo hCG and no evaluation of their reactivity were performed. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) 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 -- 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 endocrinology quality control records review (years 2017-2019) and laboratory director interview at 9:30 AM on July 26, 2019, it was determined that laboratory director failed to ensure compliance with the requirements for analytic systems. Refer to D5471. 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 endocrinology quality control records review (years 2017-2019) and laboratory director interview at 9:30 AM on July 26, 2019, it was determined that the general supervisor failed to assure that quality control procedures related to new reagent lots evaluation were performed. Refer to D5471. -- 2 of 2 --