Laboratorio Clinico El Paraiso

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on July 7, 2025 to Laboratorio Clinico El Paraiso, 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 Puerto Rico Proficiency Testing scores (years 2024-2025) and CASPER Report 0155D scores, it was determined that the laboratory obtained a unsuccessful participation in a Proficiency Testing Program for Free T4 (FT4) tests. Refer D2107. 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 -- D2107 ENDOCRINOLOGY CFR(s): 493.843(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 Puerto Rico Proficiency Testing scores (years 2024-2025) and CASPER Report 0155D scores, it was determined that the laboratory obtained an initial unsuccessful performance in two consecutive testing events for Free T4 (FT4) tests. The finding includes: 1. The Puerto Rico Proficiency and Casper Report 0155D scores, showed that the laboratory obtained the following unsuccessful scores: Analyte: Free T4 (FT4) a. Third testing event year 2024 - 60% b. First testing event year 2025 - 40% 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 Puerto Rico proficiency testing scores (years 2024-2025) and CASPER Report 0155D scores, its was determined that the laboratory director failed to ensure the laboratory's successful participation in a Proficiency Testing Program for Free T4 (FT4) tests. 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 Puerto Rico proficiency testing scores (years 2024-2025) and CASPER Report 0155D scores, it was determined that the laboratory director did not ensure that the laboratory had a satisfactory participation for Free T4 (FT4) tests during the third testing event of the year 2024 and first testing event of the year 2025. Refer to D2107. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA Recertification survey at the Laboratorio Clnico El Paraiso, on July 18, 2025. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. During a recertification survey on July 18, 2025, the laboratory was found out of compliance with the following conditions: 42 CFR 493.1210 Routine Chemitry 42 CFR 493.1212 Endocrinology 42 CFR 493.1441 Moderate Complexity Laboratory Director 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. 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 director on July 18, 2025, at 10:30 AM, it was determined that the laboratory failed to ensure compliance with the analytic system requirements for routine chemistry test. Refer to D5447 (A). D5020 ENDOCRINOLOGY CFR(s): 493.1212 If the laboratory provides services in the subspecialty of Endocrinology, 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: 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 -- Based on endocrinology quality control records review (years 2024 - 2025) and interview with the laboratory director on July 18, 2025, at 10:30 AM, it was determined that the laboratory failed to ensure compliance with the analytic system requirements for Endocrinology test. Refer to D5447 (B) . D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: A. Based on Prostatic specific antigen (PSA) quality control and patient's test worksheets records review (years 2024-2025), Federal Drug Administration access data base review and laboratory director interview on July 18, 2025, at 9:30 AM, it was determined that the laboratory failed to include two control materials of different concentrations each day of PSA patient's test, when processed and reported 239 out of 315 PSA patient's test from June 1, 2024, to July 17, 2025. The findings include: 1. The laboratory uses NanoEn Tek FREND System to perform PSA patient's tests. 2. Review of Federal Drug Administration access data base on July 18, 2025, at 9:35 AM, showed that the PSA test was classified as moderate complexity test. 3. On July 18, 2025, at 9:45 AM, the PSA quality control and patient's test worksheets records review, showed that the laboratory included two levels of control material each week, instead of two levels of control material, at least each day of patients testing. 4. The laboratory director confirmed on July 18, 2025, at 10:30 AM, that the laboratory processes two levels of control material weekly for PSA patient's test, nor each day of patient's testing. 5. The laboratory processed and reported 239 out of 315 PSA patient's test from June 1, 2024, to July 17, 2025. B. Based on 25 - hydroxyvitamin D (25-OH-D), Testosterone, Thyroxine, free (FT4) and Thyroid stimulating hormone (TSH) quality control and patient's test worksheets records review (years 2024-2025), Federal Drug Administration access data base review and laboratory director interview on July 18, 2025, at 9:30 AM, it was determined that the laboratory failed to include two control materials of different concentrations each day of 25-OH-D, Testosterone, FT4 and TSH patient's tests, when processed and reported 1085 out of 1776 Testosterone, 25-OH-D, FT4 and TSH patient's test from June 1, 2024, to July 17, 2025. The findings include: 1. The laboratory uses NanoEn Tek FREND System to perform: 25-OH-D, Testosterone, FT4 and TSH patient's tests. 2. Review of Federal Drug Administration access data base on July 18, 2025, at 9:35 AM, showed that the 25-OH-D, Testosterone, FT4 and TSH test were classified as moderate complexity test. 3. On July 18, 2025, at 9:45 AM, the endocrinology quality control and patient's test worksheets records review, showed that the laboratory included two levels of control material each week, instead of two levels of control material, at least each day of patients testing. 4. The laboratory director confirmed on July 18, 2025, at 10:30 AM, that the laboratory processes two levels of control material weekly for 25- OH-D, Testosterone, FT4 and TSH patient's tests, nor each day of patient's testing. 5. The laboratory processed and reported 1085 out of 1776 endocrinology patient's test from June 1, 2024, to July 17, 2025. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. -- 2 of 3 -- 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 on routine chemistry and endocrinology quality control records review (years 2024-2025), the patient's test worksheets records, Federal Drug Administration access data base review and laboratory director interview on July 18, 2025, at 10:30 AM, it was determined that the laboratory director (sole person) failed to fulfill him responsibilities and duties to ensure compliance with the analytic system for routine chemistry and endocrinology requirements. Refer to D6020. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(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 and endocrinology quality control records review (years 2024-2025), the patient's test worksheets records, Federal Drug Administration access data base review and laboratory director interview on July 18, 2025, at 10:30 AM, it was determined that the laboratory director (sole person) failed to include two control materials of different concentrations each day of routine chemistry and endocrinology patient's test. Refer to D5447 (A) and (B). -- 3 of 3 --