Laboratorio Clinico Riaza

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on July 7, 2025 to Laboratorio Clinico Riaza, 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 Puerto Rico Proficiency Testing scores (years 2024-2025) and 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 -- CASPER Report 0155D scores, it was determined that the laboratory obtained a unsuccessful participation in a Proficiency Testing Program for Hema Cell Id tests. Refer 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 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 Hema Cell Id tests. The finding includes: 1. The Puerto Rico Proficiency and Casper Report 0155D scores, showed that the laboratory obtained the following unsuccessful scores: Analyte: Hema Cell Id a. Third testing event year 2024 - 0% b. First testing event year 2024 - 70% 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 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 hematology tests. 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 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 Hema Cell Id tests during the third testing event of the year 2024 and first testing event of the year 2025. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An unannounced CLIA Recertification survey was conducted at the Laboratorio Clnico Riaza on January 24, 2025 by the Puerto Rico State Agency. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The following standard level deficiencies were found during the unannounced routine CLIA recertification survey on Janury 24, 2025. D2127 HEMATOLOGY CFR(s): 493.851(d) (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 review of Puerto Rico Proficiency Testing (PRPT) event scores (years 2023- 2024) and CASPER Report 0155D, Proficiency Testing Service Program 2024 Schedule and laboratory general supervisor interview on January 24, 2025, at 9:30 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 PRPT and CASPER Report were reviewed on January 24, 2025, at 9:30 A.M., from February 2023 to December 2024. 2. The Proficiency Testing Service Program 2024 Schedule, showed that the deadline of the third testing event for hematology scores was November 22, 2024. (Reviewed on January 24, 2025, at 9:35 A.M.) 3. The laboratory obtained a score of 0% in the third testing event for hematology scores. (Reviewed on January 24, 2025, at 9:40 A.M.) 4. The laboratory general supervisor confirmed on January 24, 2025, at 9:45 A.M., that the laboratory failed to report the hematology proficiency testing results of the third testing event within the time frame established by the PRPT. 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 -- D6090 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(ii) (e)(4)(ii) The results are returned within the timeframes established by the proficiency testing program; This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing scores (years 2023-2024) and CASPER Report and laboratory general supervisor interview on January 24, 2025, at 10:00 A. M, it was determined that the laboratory director failed to report the hematology proficiency testing results within the time frame established by the program, getting a score of 0% in the third event for hematology. Refer to D 2127. -- 2 of 2 --

Summary Statement of Deficiencies D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, 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: Based on Mycoplasma pneumoniae quality control records patient records review ( 2020-2021 ) and interview with the laboratory general supervisor on April 30, 2021 at 10:00 AM, it was determined that the laboratory failed to meet the requirements in the subspecialty of General Immunology. The finding includes: 1. The laboratory did not include each day of testing a negative and a positive control materials when patients serum specimens were tested for qualitative Mycoplasma IgM by the Immuno Card Mycoplasma method. Refer to : 5449- The laboratory did not include positive and negative control material 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 review of Mycoplasma pneumoniae IgM quality control results ( 2020-2021 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 -- ) , patient test results records and interview with the laboratory supervisor on April 30, 2021 at 10:00 AM, it was found that the laboratory did not include a positive and a negative control material each day of patient testing. The findings include: 1. The laboratory began to perform patient's test for Mycoplasma pneumoniae on September 2020. 2. Review of the quality control and patient test results records showed that positive and negative controls were included when a new reagent box was opened. 3. The mycoplasma quality control records ( 2020-2021) and patient test results records showed that from February 12, 2020 to April 2021 the laboratory processed and reported 132 mycoplasma IgM . 2020-114 patient 2021 -18 patient 4. The laboratory supervisor stated on April 30, 2021 at 10:00A.M., that they included a negative and a positive control material when a new reagent box was opened and documented the procedural control with each patient. 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 general immnunology quality control records review ( 2020-2021) and laboratory supervisor interview on April 30, 2021 at 10:00 A.M., it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory quality control requirements. Refer to D6093 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 general immunology quality control record review from February 2020 to April 2021 and laboratory general supervisor interview on April 30, 2021 at 10:00 A. M. it was determined that the laboratory director failed to ensure compliance with the requirement for analytic systems. The finding includes: 1. The laboratory did not include a positive and a negative control material when performed Mycoplasma IgM each day of patient testing. Refer to D5449. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on general immunology quality control record review from February 2020 to April 2021 and laboratory general supervisor interview on April 30, 2021 at 10:00 A. -- 2 of 3 -- M. it was determined that the laboratory general supervisor failed to ensure compliance with the requirement for analytic systems. The finding includes: 1. The laboratory did not include a positive and a negative control material when performed Mycoplasma IgM each day of patient testing. Refer to D5449. -- 3 of 3 --

Summary Statement of Deficiencies D2127 HEMATOLOGY CFR(s): 493.851(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 Puerto Rico Proficiency Testing Program (PRPTP) records reviewed from February 2017 to March 2019 and laboratory testing personnel interview on April 10, 2019 at 9:24 AM, it was determined that the laboratory failed to report the hematology proficiency testing results within the time frame established by the proficiency testing program. The findings include: 1. Proficiency testing records were reviewed from February 2017 to March 2019. 2. The deadline of the PRPTP first testing event report of hematology tests was March 21, 2019. 3. The laboratory did not report the PRPTP first testing event of hematology within the time frame established by the PRPTP. The laboratory obtained a score of 0% for the testing event. 4. The laboratory testing personnel confirmed on April 10, 2019 at 9:24 AM, that the laboratory did not report the hematology proficiency testing results of the PRPTP first testing event within the time frame established by the Proficiency Testing Program. 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. 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 -- This CONDITION is not met as evidenced by: 1. Based on records review and laboratory testing personnel interview on April 10, 2019 at 8:18 AM, it was determined that the laboratory director position is not filled since March 31, 2019. The findings include: a. The previous laboratory director resigned on March 31, 2019. b. The laboratory testing personnel confirmed on April 10, 2019, that the previous laboratory director resigned on March 31, 2019 and that the laboratory position position was not filled. 2. Based on proficiency records test results review on April 10, 2019, at 9:24 AM, it was determined that the laboratory failed to fulfill his responsibilities and duties to ensure compliance with the proficiency testing program. Refer to D 6090. D6090 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(ii) The laboratory director must ensure the results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program (PRPTP) records review from February 2017 to March 2019 and laboratory testing personnel interview on April 10, 2019 at 9:24 AM, it was determined that the laboratory director failed to ensure that the proficiency testing test results were returned within the time frame established by the proficiency testing program. Refer to D 2127. -- 2 of 2 --