Laboratorio Clinico Laurel

Summary Statement of Deficiencies D0000 An offsite Proficiency Test (PT) Desk Review was performed on February 12, 2026 to Laboratorio Clinico Laurel, the laboratory was found out of compliance with the following conditions: 42 CFR 493.803 Proficiency Testing, Successful Participation 42 CFR 493.1441 Laboratory Director, High 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 (year 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), the laboratory failed to achieve satisfactory performance (80% or better) for two (2) out of three (3) consecutive testing events for the specialty of hematology in the analyte for Red Blood Cell count (RBC) tests. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 (year 2025), the laboratory failed to achieve satisfactory performance (80% or better) for two (2) out of three (3) consecutive testing events for the specialty of hematology in the analyte for Red Blood Cell count (RBC) tests. The findings include: 1. Review of the Casper Report 0155D and PRPTSP scores on February 11, 2026, confirmed that the laboratory had a PT (Proficiency Test) failure for the analyte Red Blood Cell count (RBC) tests in the specialty of hematology. The laboratory obtained the following testing scores: Analyte: Red Blood Cell count (RBC) a. First testing event year 2025 - 60% b. Third testing event year 2025 - 60% 2. A review of the PRPTSP records confirmed the above findings. 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 review of Certification And Survey Provider Enhanced Reports (CASPER) 0155D and Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (year 2025), 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 D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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 (year 2025), the laboratory director failed to ensure successful participation in an HHS- approved proficiency testing program. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of validation records and laboratory director interview on July 23, 2021 at 12:05 PM, it was determined that the laboratory failed to complete the evaluation of the performance specifications of following test by the new cobas e 411 analyzer: Thyroxin (T4) free, T4 Total, triiodothyronine (T3) uptake, thyroid stimulating hormone (TSH) , Vitamin-D and prostate specific antigen (PSA) before reporting 4,192 out of 4,192 test results from October 1, 2020 to July 20, 2021. The findings include: 1. The laboratory validated the cobas e 411 analyzer on August 26, 2020 to processed the following tests since October 1, 2020: T4 free, T4 Total, T3 uptake, TSH , Vitamin-D and PSA. 2. On July 23, 2021 at 12:05 PM, the cobas e 411 analyzer validation records showed that the laboratory did not verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population before reporting patients tests. 3. The laboratory director confirmed on July 23, 2021 at 12:05 PM, that the laboratory did not verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. 4. The laboratory processed and reported the following 4,192 patients tests from October 1, 2020 to July 20, 2021: Test Patient's tests reported a. T4 free 347 b. T4 Total 435 c. T3 uptake 337 d. TSH 1910 e. Vitamin-D 796 f. PSA 367 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 -- 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 validation records review and interview with the laboratory director on on July 23, 2021 at 12:05 PM, it was determined that the laboratory director failed to comply with the requirements of the following tests from October 1, 2020 to July 20, 2021:T4 free, T4 Total, T3 uptake, TSH , Vitamin-D and PSA. Refer to D5421 (The laboratory did not verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population before reporting patients tests). -- 2 of 2 --

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)