Lab Clinico Plaza Centro

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on May 14, 2026 to Laboratorio Clnico Plaza Centro, 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 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 -- 2025-2026), the laboratory failed to achieve satisfactory performance (80% or better) for two (2) out of three (3) consecutive testing events for the subspecialty of routine chemistry in the analyte Uric Acid 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 three (3) consecutive testing events for the subspecialty of Routine Chemistry in the analyte Uric Acid 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 in the subspecialty of Routine Chemistry in the analyte Uric Acid tests. The laboratory obtained the following testing scores: Analyte: Uric Acid a. Second testing event year 2025 - 60% b. First testing event year 2026 - 40% 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 Laboratorio Clinico Plaza Centro on August 13, 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 August 13, 2025. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: Based on urinalysis quality control records review (years 2024-2025) and laboratory director interview on August 13, 2025 at 11:56 AM, it was determined that the laboratory failed to verify the stated value of the new lot of control materials (normal and abnormal controls), when the laboratory processed and reported 1250 patient urinalysis samples from July 1, 2024 to August 13, 2025. The findings include: 1. The laboratory performs urinalysis tests with the Mission U120 Ultra Urine Analyzer. 2. The urinalysis quality control records reviewed (years 2024-2025) on August 13, 2025 at 11:46 AM, from July 1, 2024 to August 13, 2025, showed that there was no evaluation of the manufacturer's stated values for the normal control material lot number UB1526011A, and abnormal control material lot number UB1526012A, prior 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 -- to placing them in routine use on July 1, 2024. 3. The laboratory director confirmed on August 13, 2025 at 11:56 AM, that the laboratory failed to evaluate the stated value of the new lot of control materials for urinalysis tests prior to placing them in routine use, performed by the Mission U120 Ultra Urine Analyzer, when they processed and reported 1250 patient samples from July 1, 2024 to August 13, 2025. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Mycoplasma Pneumoniae IgM test quality control records review (years 2024-2025), manufacturer's instructions review, Individualized Quality Control Plan (IQCP) review, and laboratory director interview on August 13, 2025 at 12:30 PM; it was determined that the laboratory did not document the procedural control for negative and positive controls, when 81 patient specimens were processed and reported for Mycoplasma pneumoniae IgM test from January 8, 2025 to August 13, 2025. The findings include: 1. The laboratory uses the Immuno Card Mycoplasma kit to perform the Mycoplasma pneumoniae IgM tests. 2. On August 13, 2025 at 12:15 PM, the IQCP for Mycoplasma pneumoniae IgM tests was reviewed, and it was approved and signed by the laboratory director on January 2, 2025, and it establishes to record and evaluate Quality Control (QC) results according to QC acceptability criteria, and document the procedural control with any specimen or control reagent. 3. On August 13, 2025 at 12:20 PM the manufacturer's instructions were reviewed, and it establishes to document the procedural control with any specimen or control reagent, to test the individual specimen for proper flow and reagent performance. 4. On August 13, 2025 at 12:22 PM; the quality control records (years 2024-2025) of Mycoplasma Pneumoniae IgM test were reviewed, and showed that the laboratory did not document the procedural control for negative and positive controls from January 8, 2025 to August 13, 2025. 5. The laboratory director confirmed on August 13, 2025 at 12:30 PM, that the laboratory did not document the procedural control for negative and positive controls, when 81 patient specimens were processed and reported for Mycoplasma pneumoniae IgM test from January 8, 2025 to August 13, 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 and Mycoplasma Pneumoniae IgM quality control records, manufacturer's instructions, and interview with the laboratory director on August 13, 2025 at 12:30 PM, it was determined that the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the manufacturer's instructions and laboratory quality control requirements. Refer to D5469 and D5481. -- 2 of 3 -- 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 Mycoplasma Pneumoniae IgM test quality control records review (years 2024-2025), manufacturer's instructions review, Individualized Quality Control Plan (IQCP) review, urinalysis quality control records, and interview with the laboratory director, and general supervisor (also testing personnel), it was determined that the laboratory general supervisor failed to monitor test analyses and specimen examinations to ensure that acceptable levels of analytic performance are mantained for Mycoplasma Pneumoniae IgM and urinalysis tests. Refer to D5469 and D5481. -- 3 of 3 --