Laboratorio Clinico Yesmar

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at Laboratorio Clinico Yesmar on January 29, 2026. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following condition and standard level deficiencies were found during the recertification CLIA survey ending on January 29, 2026. 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 review of the Mycoplasma pneumoniae IgM quality control records ( August 2025 - January 2026 ) on January 29, 2026 at 10:00 A.M., and laboratory director interview; the laboratory failed to meet the quality control requirements for Mycoplasma pneumoniae IgM test. Refer to D5449. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on the Mycoplasma pneumoniae IgM quality control records review, and laboratory director interview on January 29, 2026 at 10:00 AM, the laboratory failed to include an external negative and positive control material , each day of patient testing. The laboratory processed and reported 37 patient samples from September 8, 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 to January 28, 2026. The findings include: 1. The laboratory begin to uses the Immuno Card Mycoplasma kit to perform the Mycoplasma pneumoniae IgM tests on August 15, 2025. 2. Review of the Mycoplasma pneumoniae IgM test quality control records on January 29, 2026 at 10:00 AM, showed that the laboratory did not include the external negative and positive control material, each day of patient testing, when the laboratory processed and reported 37 patient samples from September 8, 2025 to January 29, 2026. 3. The laboratory director confirmed on January 29, 2026 at 11:30 AM, that the laboratory failed to include an external negative and positive control material, each day of patient testing. The laboratory processed and reported 37 patient samples from September 8, 2025 to January 29, 2026. 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 Mycoplasma Pneumoniae IgM quality control records ( August 2025 - January 2026) and interview with the laboratory director on January 29, 2026 at 11:30 AM, the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the laboratory quality control requirements. ( see 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 Mycoplasma Pneumoniae IgM quality control records review, and interview with the laboratory director on January 29, 2026 at 10:00 AM, the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the laboratory quality control requirements. ( see D5449). -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on September 12, 2024 to Laboratorio Clnico Yesmar, 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 2023- 2024) and CASPER Report 0155D scores, it was determined that the laboratory obtained an unsuccessful participation in a Proficiency Testing Program for Prothrombin time (PT). Refer to D2130 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 -- D2130 HEMATOLOGY CFR(s): 493.851(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 2023-2024) and CASPER Report 0155D scores, it was determined that the laboratory obtained an unsuccessful participation in two out of three consecutive testing events for the following routine Prothrombiin (PT) tests. The finding includes: 1. The Puerto Rico Proficiency Testing and CASPER Report 0155D scores, showed that the laboratory obtained following unsuccessful scores: Analyte: Prothrombin (PT) a. Third testing event for the year 2023 (60%) b. Second testing event for the year 2024 (60%). 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 Puerto Rico Proficiency Testing scores (years 2023- 2024) and CASPER Report 0155D scores, it was determined that the laboratory director failed to ensure the laboratory's successful participation in a Proficiency Testing Program for Prohrombin time (PT) tests. Refer to D6079 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 Puerto Rico Proficiency Testing scores (years 2023- 2024) and CASPER Report 0155D scores, it was determined that the laboratory director did not ensure that the laboratory had a satisfactory participation for Prothrombin time (PT) tests during the third testing event of year 2023 and second testing event of year 2024. Refer to D2130 -- 2 of 2 --