Lab Clinico Munoz Rivera

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on August 18, 2025 to Laboratorio Clinico Muoz Rivera, 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 Service Program (PRPTSP) scores (year 2025) and CASPER Report 0155D scores, it was determined that the laboratory obtained a unsuccessful participation in a Proficiency Testing Program for Uric Acid and Glycosylated hemoglobin (HA1C) tests. Refer D2096. 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 -- 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 Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (year 2025) and CASPER Report 0155D scores, it was determined that the laboratory obtained an initial unsuccessful performance in two out of two consecutive testing events for Uric Acid and Glycosylated Hemoglobin (HA1C) tests. The findings include: 1. The Puerto Rico Proficiency and Casper Report 0155D scores, showed that the laboratory obtained the following unsuccessful scores: Analyte: Uric Acid a. First testing event year 2025 - 40% b. Second testing event year 2025 - 60% 2. The Puerto Rico Proficiency and Casper Report 0155D scores, showed that the laboratory obtained the following unsuccessful scores: Analyte: Glycosylated Hemoglobin (HA1C) a. First testing event year 2025 - 20% b. Second testing event year 2025 - 0% 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 Service Program (PRPTSP) scores (year 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 Uric Acid and Glycosylated Hemoglobiin (HA1C) 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 Service Program (PRPTSP) scores (year 2025) and CASPER Report 0155D scores, it was determined that the laboratory director did not ensure that the laboratory had a satisfactory participation for Uric Acid and Glycosylated Hemoglobin (HA1C) tests during the first testing event of the year 2025 and second testing event of the year 2025. 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 Munoz Rivera on July 10, 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 July 10, 2025. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: A. Endocrinology Based on endocrinology instrument Roche Cobas e411 maintenance quality control records, and laboratory supervisor interview on July 10, 2025 at 9:51 AM, it was determined that the laboratory failed to perform the weekly maintenance of the instrument, when 11,116 patient specimens were processed and reported for endocrinology tests from January 1, 2024 to July 10, 2025. The findings include: 1. The laboratory uses the Roche Cobas e411 instrument to perform patient's endocrinology tests. 2. On July 10, 2025 at 9:51 AM, the Roche Cobas e411 instrument maintenance quality control records were reviewed, and showed that the laboratory failed to perform the following weekly maintenance: Clean incubator and aspiration station, and Clean Sipper Probe, when they processed and reported 11,116 patient specimens from January 1, 2024 to July 10, 2025. 3. The laboratory supervisor confirmed on July 10, 2025 at 9:56 AM, that the laboratory did not perform the weekly maintenance of the endocrinology instrument. B. Chemistry Based on chemistry instrument Randox RX daytona maintenance quality control records, and laboratory supervisor interview on July 10, 2025 at 10:24 AM, it was determined that 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 failed to perform the following instrument maintenance: before starting, daily, weekly, monthly and unscheduled, when 6,600 patient specimens were processed and reported for chemistry tests from January 1, 2024 to July 10, 2025. The findings include: 1. The laboratory uses the Randox RX daytona instrument to perform patient's chemistry tests. 2. On July 10, 2025 at 10:24 AM, the Randox RX daytona instrument maintenance quality control records were reviewed, and showed that the laboratory failed to perform the following instrument maintenance: before starting, daily, weekly, monthly and unscheduled, when they processed and reported 6,600 patient specimens from January 1, 2024 to July 10, 2025. 3. The laboratory supervisor confirmed on July 10, 2025 at 10:29 AM, that the laboratory did not perform the maintenance of the chemistry instrument. 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 endocrinology and chemistry instrument maintenance quality control records, and interview with the laboratory supervisor on July 10, 2025 at 10:29 AM, 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 D5411. -- 2 of 2 --

Summary Statement of Deficiencies D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(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-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on syphilis serology testing records (years 2022 and 2023) review and laboratory supervisor interview on August 16, 2023 at 11:43 AM, it was determined that the laboratory failed to include at least once a day, a negative control material besides a control material with tittered reactivity when 3 out 3 patients specimens were tested for syphilis serology by rapid plasma reagin (RPR) quantitative tests by ASI method from April 12, 2023 to May 16, 2023. The findings include: 1. The laboratory processed and reported the RPR quantitative tests by ASI method. 2. On August 16, 2023 at 11:30 AM, the syphilis serology testing records was reviewed and showed that the laboratory did not include at least once a day, the negative control material besides the control material with tittered reactivity when 3 out 3 patients specimens were tested for RPR quantitative tests by ASI method from April 12, 2023 to May 16, 2023. 3. The laboratory supervisor confirmed on August 16, 2023 at 11:43 AM, that the laboratory did not include the negative control material and the control material tittered reactivity when it performed the quantitative RPR test. She stated that the laboratory includes this control material when it processing the qualitative RPR test. 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 Syphilis Serology test quality control records (year 2022 and 2023) review and interview with the laboratory supervisor on August 16, 2023 at 11:43 AM, it was determined that the laboratory director failed to ensure that the laboratory maintain the quality control procedures for the Rapid Reagin Plasma test (RPR) quantitative test. Refer to D5451. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratorio Clnico Muoz Rivera was found to be in substantial compliance with CLIA regulations (42 CFR Part 493, effective April 24, 2003). No deficiencies were cited as a result of a remote survey process performed on October 26, 2021. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on Covid-19 report records review and general supervisor interview on October 26, 2021 at 11:45 AM, it was determined that the laboratory failed to report the Covid- 19 results as required for 14 out of 15 days reviewed from May 11, 2021 to June 15, 2021. The findings include: 1. The laboratory utilized the Health Department instruction to send the Covid-19 results to the Bioportal. 2. The laboratory processed the Covid-19 test by the Rapid Covid 19 test (Covibloc Clarity) and by Covid-19 Antigen (Binax now). 3. On October 26, 2021 at 11:45 AM, the Covid-19 rapid report records showed that the laboratory did not send the Covid-19 results in the required frequency (24 hrs) to the Bioportal in 9 out of 10 days reviewed from May 26, 2021 to June 15, 2021: Date Patients Date tested specimens reports tested sent 05/26/2021 5 06 /02/2021 05/28/2021 1 06/02/2021 05/29/2021 1 06/02/2021 06/02/2021 2 06/07/2021 06/03/2021 3 06/07/2021 06/07/2021 1 06/15/2021 06/08/2021 1 06/15/2021 06/09 /2021 1 06/15/2021 06/12/2021 1 06/15/2021 4. On October 26, 2021 at 11:45 AM, the Covid-19 antigen report records showed that the laboratory did not send the Covid- 19 results in the required frequency (24 hrs) to the Bioportal in five out of five days reviewed from May 11, 2021 to May 15, 2021: 05/11/2021 4 05/17/2021 05/12/2021 3 05/17/2021 05/13/2021 3 05/17/2021 05/14/2021 2 05/17/2021 05/15/2021 1 05/17 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 -- /2021 5. The general supervisor confirmed on October 26, 2021 at 11:45 AM, that the laboratory did not send those Covid-19 results in the required frequency (24 hrs) to the Bioportal during those periods. -- 2 of 2 --