Laboratorio Clinico Rex

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA Recertification survey at the Laboratorio Clnico Rex, on December 3, 2025. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. During a recertification survey on December 3, 2025, the laboratory was found out of compliance with the following conditions: 42 CFR 493.1100 Facility Administration 42 CFR 493.1207 Syphilis Serology 42 CFR 493.1211 Urinalysis 42 CFR 493.1212 Endocrinology 42 CFR 493.1215 Hematology 42 CFR 493.1250 Analytic Systems 42 CFR 493.1441 Laboratory Director D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2024-2025), and laboratory director interview on December 3, 2025, at 10:07 a.m., it was determined that the laboratory director failed to sign the attestation statements for the proficiency testing events for the years 2024 and 2025. The findings include: 1. The PRPTSP scores were reviewed from February 2024 through September 2025. 2. The laboratory director did not sign the attestation statements for the proficiency testing records from February 2024 through September 2025. 3. The laboratory director confirmed on December 3, 2025, at 11:15 a.m., that she failed to sign the attestation statements for the years 2024 and 2025. D2127 HEMATOLOGY CFR(s): 493.851(d) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- (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 the Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (year 2025), CASPER Report 0155D, the Proficiency Testing Service Program 2025 Schedule, and laboratory director interview on December 3, 2025, at 11:02 a.m., it was determined that the laboratory failed to report the hematology proficiency testing results within the time frame established by the program. The findings include: 1. The PRPTSP scores and CASPER Report 0155D were reviewed for February 2024 through September 2025. 2. The Proficiency Testing Service Program 2025 Schedule showed that the reporting deadline for the second hematology proficiency testing event was July 29, 2025. The laboratory obtained a score of 0% for this second event. 3. The laboratory director confirmed on December 3, 2025, at 11:15 a.m., that the laboratory failed to report the hematology proficiency testing results for the second event within the time frame established by the PRPTSP. D2128 HEMATOLOGY CFR(s): 493.851(e) (e)(1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (year 2024), CASPER Report 0155D, and laboratory director interview on December 3, 2025, at 9:30 a.m., it was determined that the laboratory failed to take and document

Summary Statement of Deficiencies D2053 PARASITOLOGY CFR(s): 492.829(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) Remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program records review and laboratory director interview on December 7, 2023 at 10:00 AM, it was determined that the laboratory failed to take and document

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on Prothrombin Time (PT), Partial Thromboplastin Time (PTT) and Mycoplasma pneumoniae tests quality control records reviewed from January 2020 to March 25, 2022 and laboratory supervisor interview, it was determined that the laboratory failed to retain quality control records for at least 2 years. The finding includes: 1. On March 25, 2022 at 1:20 PM, the lack of records showed that the laboratory did not retain the PT, PTT and Mycoplasma pneumoniae tests quality control records for at least 2 years. Refer to D 3031. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 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 6 -- This STANDARD is not met as evidenced by: Based on Prothrombin Time (PT), Partial Thromboplastin Time (PTT) and Mycoplasma pneumoniae tests quality control records reviewed from January 2020 to March 25, 2022 and laboratory supervisor interview, it was determined that the laboratory failed to retain the PT, PTT and Mycoplasma pneumoniae tests quality control records for at least 2 years. The findings include: 1. The laboratory processed and reported the PT and PTT tests by the BFT II system from January 2020 to March 25, 2022. 2. On March 25, 2022 at 11:40 AM, the laboratory did not have available the Levy Jennings charts of the PT and PTT controls from June 23, 2020 to March 24, 2022. 3. On March 25, 2022 at 1:20 PM, the laboratory did not retain the Mycoplasma pneumoniae test quality control records from 12/24/2020 to 01/21/2022). Refer to D 5449. 4. The general supervisor confirmed on March 25, 2022 at 1:28 PM that those quality control records are not available in the laboratory. She stated that the Levy Jennings charts of the PT and PTT controls are at her home. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on laboratory competence schedule, personnel file review and laboratory director interview, it was determined that the laboratory failed to follow the established schedule for the general supervisor competence evaluation since April 30, 2019. The findings include: 1. On March 25, 2022 at 9:45 AM, the competence schedule was reviewed. The schedule showed that the general supervisor competence must be performed every year. 2. On March 25, 2022 at 9:47 AM, the general supervisor personnel file was reviewed, showing that the last competence evaluation was performed on April 30, 2019. 3. The laboratory director confirmed on March 25, 2022 at 9:49 AM, that the competence of the general supervisor is not performed every year since April 30, 2019. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on personnel competence records, Quality Assessment (QA) procedures manual, QA activities records review and laboratory director interview, it was determined that laboratory failed to follow the established schedule to evaluate and monitor the General Laboratory system requirements since January 2020. The findings include: 1. On March 25, 2022 at 11:00 AM, the laboratory QA procedures manual showed that the evaluation of the following General Laboratory system requirements must be performed monthly: Patient confidentiality, Specimen identification and integrity, Complaint investigations, Communications and -- 2 of 6 -- Proficiency testing performance. The QA manual also showed that the monitoring of the personnel competence procedures must be document every year. 2. On March 25, 2022 at 11:05 AM, review of the QA records showed that the laboratory did not evaluate monthly the General Laboratory System requirements since January 2020, neither monitored the every year personnel competence. 3. The laboratory director confirmed on March 25, 2022 at 11:10 AM, that those evaluations were not performed nor documented as laboratory required. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on QA procedures manual review and laboratory director interview, it was determined that laboratory failed to follow the established schedule to evaluate and monitor the following analytic system requirements since January 2020: test requests. The findings include: 1. On March 25, 2022 at 11:00 AM, the laboratory QA procedures manual showed that the evaluation of the test requests must be performed twice a year. 2. On March 25, 2022 at 11:05 AM, review of the QA records showed that the laboratory did not evaluate the test request during year 2020, during the year 2021 the laboratory evaluated the test request on December 21, 2021. 3. The laboratory director confirmed on March 25, 2022 at 11:10 AM, that those evaluations were not evaluated nor documented as laboratory required since January 2020. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Mycoplasma pneumoniae test quality control records (year 2020 to 2022) review, Mycoplasma pneumoniae test report records review and interview with the laboratory supervisor, it was determined that the laboratory did not include each day of testing an external reactive and non reactive control materials when 25 out of 25 patients specimens were tested and reported for of Mycoplasma pneumoniae qualitative test from 12/24/2020 to 01/21/2022. The findings include: 1. The laboratory use the Immuno Card Mycoplasma Test Cassette to perform the Mycoplasma pneumoniae qualitative tests since 04/17/2020. The laboratory validate this tests on 02/25/2020. 2. On March 25, 2022 at 1:20 PM, the laboratory did not have available in the laboratory the Mycoplasma pneumoniae quality control records from 12/24/2020 to 01/21/2022. 3. On March 25, 2022 at 1:24 PM, the Mycoplasma pneumoniae tests reports records showed that the laboratory tested and reported 25 out of 25 patients specimens for of Mycoplasma pneumoniae qualitative test from 12/24 /2020 to 01/21/2022: Pt ID Report Date 127215 12/24/2020 128108 05/11/2021 -- 3 of 6 -- 128441 07/09/2021 128643 08/11/2021 128690 08/19/2021 128700 08/23/2021 128716 08/24/2021 128831 09/10/2021 128869 09/17/2021 128915 09/24/2021 128930 09/27/2021 128948 09/29/2021 128993 10/06/2021 129019 10/11/2021 129169 11/05/2021 129223 11/16/2021 129234 11/18/2021 129290 12/01/2021 129345 12/13/2021 129390 12/22/2021 129404 12/24/2021 129452 01/04/2022 129487 01/07/2022 129556 01/14/2022 129625 01/21/2022 4. The laboratory supervisor confirmed on March 25, 2022 at 1:28 PM, that the Mycoplasma pneumoniae quality control records from 12/24/2020 to 01/21/2022 were not available in the laboratory. She stated that the laboratory run each day of testing, the external reactive and the non reactive control materials but did not record the controls results those days. 5. The laboratory tested and reported 25 out of 25 patients specimens for of Mycoplasma pneumoniae qualitative test from 12/24/2020 to 01/21/2022. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on QA procedures manual review and laboratory director interview, it was determined that laboratory failed to follow the established schedule to evaluate and monitor the analytic system requirements since January 2020. The findings include: 1. On March 25, 2022 at 11:00 AM, the laboratory QA procedures manual showed that the evaluation of the analytic system requirements must be performed monthly for the following specialties: parasitology, syphilis serology, general serology, endocrinology, urinalysis, virology, hematology and immunohematology. 2. On March 25, 2022 at 11:05 AM, review of the QA records showed that the laboratory did not evaluate monthly the analytic system requirements since January 2020. 3. The laboratory director confirmed on March 25, 2022 at 11:10 AM, that those evaluations are not documented since January 2020. 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 PT, PTT and Mycoplasma pneumoniae tests quality control records retention, Mycoplasma pneumoniae test quality control records, QA records reviewed, laboratory supervisor and laboratory director interview, it was determined that the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the laboratory records retention requirement, Mycoplasma pneumoniae analytical system and QA requirements. The findings include: 1. On March 25, 2022 at 1:20 PM, the laboratory director did not comply with the Laboratory records retention requirements. Refer to D 6079 2. On March 25, 2022 at 1:20 PM, the laboratory director did not not comply with the Mycoplasma pneumoniae analytical systems -- 4 of 6 -- requirements. Refer to D 6093. 3. On March 25, 2022 at 9:45 AM, the laboratory director did not not comply with the QA requirements. Refer to D 6094. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on PT, PTT and Mycoplasma pneumoniae tests quality control records reviewed from January 2020 to March 25, 2022 and laboratory supervisor interview, it was determined that the laboratory director failed to ensure that the laboratory retain the quality control records for at least 2 years. The finding includes: 1. Review of the PT, PTT and Mycoplasma pneumoniae tests quality control records on March 25, 2022 at 1:20 PM, showed that the laboratory did not retain quality control records for at least 2 years. Refer to D 3000 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 Mycoplasma pneumoniae test quality control records (year 2020 to 2022) review, Mycoplasma pneumoniae test report records review and interview with the laboratory supervisor, it was determined that the laboratory director failed to maintain the quality control procedures for the Mycoplasma pneumoniae qualitative test. The finding includes: 1. On March 25, 2022 at 1:20 PM, the quality control records reviewed, showed that the laboratory did not include each day of testing an external reactive and non reactive control materials when 25 out of 25 patients specimens were tested and reported for of Mycoplasma pneumoniae qualitative test from 12/24/2020 to 01/21/2022. Refer to D 5449. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. -- 5 of 6 -- This STANDARD is not met as evidenced by: Based on personnel records, QA records reviewed and laboratory director interview, it was determined that laboratory director failed to ensure compliance with QA requirements. The findings include: 1. On March 25, 2022 at 9:45 AM, the QA records reviewed showed that the laboratory director did not follow the annual schedule evaluations in the QA program for the laboratory supervisor competency requirement. Refer to D 5209 2. On March 25, 2022 at 11:00 AM, the QA records reviewed showed that the the laboratory director did not follow the schedule evaluations in the QA program for the General Laboratory system requirements. Refer to D 5291 3. On March 25, 2022 at 11:00 AM, the QA records reviewed showed that the the laboratory director did not follow the schedule evaluations in the QA program for the Test request requirement. Refer to D 5391. 4. On March 25, 2022 at 11:00 AM, the QA records reviewed showed that the the laboratory director did not follow the schedule evaluations in the QA program for the Analytic system requirements. Refer to D 5791 -- 6 of 6 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Individualized Quality Control Plan (IQCP) in Bacteriology and interview with the testing personnel at 10:30 AM on November 15, 2019, the laboratory failed to develop complete IQCP plans for the Microscan identification system and antimitocrobial sensitivity test, and culture media from January 1, 2019 to November 14, 2019. The findings included: 1. The IQCP for the Microscan Identification system, Microscan Antimicrobial Sensitivity test and culture media did not include the following requirements: a. The Risk Assessment (RA) information (potential failure modes, possible failure cause, estimate the probability that the failures would occur and estimate the probability would lead to a hazardous situation). b. The Quality Control Plan (QCP) did not have the approval signature of the laboratory director. c. The Quality Assessment (QA) section was not included. 2. The testing personnel stated at 10:30 AM on November 15, 2019, the laboratory evaluated the risk assessment of those tests during de year 2018 but did not documented the three sections of the IQCP. 3. The laboratory processed 30 pastiest specimens for Microscan identification and antimitocrobial sensitivity test from January 1, 2019 to November 14, 2019. 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 -- D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on white blood cells (WBC) differential results comparison records (years 2017, 2018 and 2019) and testing personnel interview at 9:45 AM on November 15, 2019, it was determined that the laboratory failed to evaluates twice a year the relationship of the WBC differential results between the manual method and the Coulter JT system from October 28, 2017 to June 11, 2019. The findings include: 1. The laboratory performed the WBC differential results by two method: manual examination and by the Coulter JT system. 2. The comparison records for the WBC differential results records showed that the laboratory did not evaluated twice a year the relationship of the WBC differential results between the manual method and the Coulter JT system from October 28, 2017 to June 11, 2019. The laboratory performed the WBC differential results comparison on October 28, 2017, May 2, 2018 and June 11, 2019. 3. The testing personnel confirmed at 9:45 AM on November 15, 2019, that the laboratory did not evaluated twice a year the relationship of the WBC differential results between the manual method and the Coulter JT system from October 28, 2017 to June 11, 2019. 4. The laboratory reported the following manual WBC differential patients results: #121082 on 09/05/2018, #121322 on 10/03/2018, #121685 on 11/21 /2018, #121692 on 11/21/2018, #121928 on 12/19/2018, #124617 on 11/05 /2019#124618 on 11/05/2019 #124626 on 11/06/2019, #124662 and # 124673 on 11 /12/2019. 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 review of Individualized Quality Control Plan (IQCP) in Bacteriology subspecialty, white blood cells (WBC) differential results comparison records (years 2017, 2018 and 2019) and interview with the testing personnel at 10:30 AM on November 15, 2019, the laboratory director failed to comply with the analytic system requirements. Refer to D 5445 (The laboratory failed to develop complete IQCP plans for the Microscan identification system and antimitocrobial sensitivity test, and culture media from January 1, 2019 to November 14, 2019). Refer to D 5775 (The laboratory failed to evaluates twice a year the relationship of the WBC differential results between the manual method and the Coulter JT system from October 28, 2017 to June 11, 2019). D6177 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(3) -- 2 of 3 -- Each individual performing high complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on white blood cells (WBC) differential results comparison records (years 2017, 2018 and 2019) and testing personnel interview at 9:45 AM on November 15, 2019, it was determined that the testing personnel failed to follow quality control procedures from October 28, 2017 to June 11, 2019. Refer to D 5775 (The laboratory failed to evaluates twice a year the relationship of the WBC differential results between the manual method and the Coulter JT system from October 28, 2017 to June 11, 2019). -- 3 of 3 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --