La Clinica (Mcc) Rrl - Quest Diagnostics

Summary Statement of Deficiencies D0000 The La Clinica (MCC) RRL - Quest Diagnostics laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the proficiency testing desk review survey performed on April 9, 2025. The following condition-level deficiency was cited: 493.303 Successful Participation The following standard-level deficiency was cited: 493.841 Routine Chemistry . 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 proficiency testing (PT) reports from the Center for Medicare and Medicaid Services (CMS) and the American Proficiency Institute (API), the 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 -- laboratory failed to successfully participate in PT for multiple analytes under the subspecialty Routine Chemistry in 2024 and 2025. Finding are as follows: 1. The CMS CASPER Report 0155D and the API 2024 Chemistry Core - 3rd Event Performance Summary and Comparative Evaluation and the API 2025 Chemistry Core - 1st Event Performance Summary and Comparative Evaluation were reviewed on April 9, 2025. 2. The reports indicated the laboratory failed to achieve satisfactory performance for multiple analytes in two consecutive testing events from 2024 and 2025 resulting in unsuccessful performance of the analytes (see D2093 and D2096) and the subspecialty (see D2097). . D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) (d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: . Based on review of proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to submit Routine Chemistry PT results to API prior to the submission deadline. Findings are as follows: 1. The laboratory failed to submit PT results for each of the following analytes for the 2024 Chemistry Core 3rd event. Failure to participate in the testing event resulted in a score of 0% and unsatisfactory performance for each of the analytes listed below. Chloride Creatinine Glucose Potassium Sodium Blood Urea Nitrogen . 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 proficiency testing (PT) reports from American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for multiple analytes in two consecutive testing events in 2024 and 2025, constituting unsuccessful performance. Findings are as follows: 1. The API 2024 Chemistry - Core 3rd Event Performance Summary and Comparative Evaluation and the 2025 API Chemistry - Core 1st Event Performance Summary and Comparative Evaluation were reviewed on April 9, 2025. The API reports indicated the laboratory had unsatisfactory performance for the analytes listed below: Event scores 2024-3 2025-1 Chloride 0% 60% Creatinine 0% 60% Glucose 0% 60% Potassium 0% 60% Sodium 0% 60% BUN* 0% 60% *Blood Urea Nitrogen . D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) (g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. -- 2 of 3 -- This STANDARD is not met as evidenced by: . Based on review of proficiency testing scores from the American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for the Routine Chemistry subspecialty in two consecutive testing events, constituting unsuccessful performance for the subspecialty. Findings are as follows: 1. The API 2024 Chemistry - Core 3rd Event Performance Summary and Comparative Evaluation and the 2025 API Chemistry - Core 1st Event Performance Summary and Comparative Evaluation were reviewed on April 9, 2025. The reports from API indicated the laboratory had unsatisfactory performance for the Routine Chemistry subspecialty as listed below: Unsatisfactory Routine Chemistry PT performance was obtained in the following events. -2024 3rd event 0% -2025 1st event 60% . -- 3 of 3 --

Summary Statement of Deficiencies D0000 The La Clinica (MCC) RLL - Quest Diagnostics laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey performed on May 30, 2024. The following standard-level deficiencies were cited: 493.1254 Maintenance and function checks . D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with laboratory personnel, the laboratory failed to take

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on observation and interview with laboratory personnel, the laboratory failed to perform and document function checks for 1 of 2 centrifuges in 2021. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory on 07/13/22, at 1:00 p.m. 2. A Horizon centrifuge was observed as present and available for use in the laboratory during the tour. 3. The laboratory's Centrifuge Maintenance procedure, found in the policy software SmartSolve, indicated the centrifuge tachometer and timer functions were verified annually. 4. Documentation of 2021 laboratory centrifuge function check was not found during review of laboratory records. 5. During an interview at 4: 45 p.m. on 07/13/22, the LD confirmed the above finding. The laboratory was give five business days to provide the function check documentation. 6. In an email received at 4:06 p.m. on 07/19/22, the LD indicated the 2021 laboratory centrifuge function check records were not found. 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 --

Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to ensure quality control (QC) was performed each day of Chemistry patient specimen testing. Findings are as follows: 1. The laboratory performed Chemistry testing as indicated on the Clinical Laboratory Improvement Amendment (CLIA) Application for Certification Form CMS-116, and confirmed by the Laboratory Director (LD) during a tour of the laboratory on 03/03/21, at 9:05 a.m. 2. External QC performance for a Chemistry 8 profile and Troponin were established in the Chem 8+ Cartridge on the Abbott i-STAT, and Cardiac Troponin I on the Abbott i-STAT procedures, both found in the on-line Procedure Manual. 3. Laboratory records revealed that external QC was performed every 30 days, with each new shipment, and each new lot number of reagents, as defined in the test method procedures noted. 4. Individualized Quality Control Plans (IQCP) for Chemistry 8 profile and Troponin, each on the Abbott i-STAT, were not found in laboratory records. The laboratory was unable to provide the IQCP's for either upon request. 5. In an interview on 03/03/21, at 11:15 a.m., the LD confirmed the above findings. . 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 --