Laboratorio Clinico Irizarry Guash

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on June 30, 2026 to Laboratorio Clnico Irizarry Guasch, 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 Certification And Survey Provider Enhanced Reports (CASPER) 0155D and Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (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 2 -- 2025-2026), the laboratory failed to achieve satisfactory performance (80% or better) for two (2) out of two (2) consecutive testing events for the specialty of hematology in the analyte for Red Blood Cell Count (RBC) tests. Refer to 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 Certification And Survey Provider Enhanced Reports (CASPER) 0155D and Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2025-2026), the laboratory failed to achieve satisfactory performance (80% or better) for two (2) out of two (2) consecutive testing events for the specialty of hematology in the analyte for Red Blood Cell Count (RBC) tests. The findings include: 1. Review of the Casper Report 0155D and PRPTSP scores on June 21, 2026, confirmed that the laboratory had a PT (Proficiency Test) failure for the analyte Red Blood Cell Count (RBC) tests in the specialty of hematology. The laboratory obtained the following testing scores: Analyte: Red Blood Cell Count (RBC) a. Third testing event year 2025 - 60% b. First testing event year 2026 - 60% 2.A review of the PRPTSP records confirmed the above findings. 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 Certification And Survey Provider Enhanced Reports (CASPER) 0155D and Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2025-2026), the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure proficiency testing samples were tested as required. 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 review of Certification And Survey Provider Enhanced Reports (CASPER) 0155D and Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2025-2026), the laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on bacteriology culture media quality control records review from January 20, 2016 to December 9, 2017 and laboratory director and testing personnel interview on January 25, 2018 at 10:42 AM, it was determined that the laboratory failed to check each batch of cultures media plates used at the laboratory for selectivity and or inhibition and biochemical response since January 20, 2016. The findings include: 1. Review of the bacteriology culture media quality control records showed that the following agar plates were being used: Blood Agar (BA), Mac Conkey and Thioglycolate medium (THIO). 2. From January 20, 2016, the laboratory received the following: Media Total of different lot numbers a. Blood Agar (BA) 15 lots b. Mac Conkey 15 lots c. THIO 7 lots 3. The laboratory processed 1,018 patient's cultures samples from January 1, 2016. 4. The laboratory director and testing personnel stated that no evaluation of the ability to support growth was performed from January 20, 2016. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an 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 -- 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 quality assessment (QA) records review and laboratory director and testing personnel interview on January 25, 2018 at 11:02 AM, it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the requirement for analytic systems. The findings include: 1. Review of the laboratory quality assessment manual showed that for each analytic process a log sheet was designate to keep track of the laboratory performance. 2. The laboratory did not evaluate aspects regarding the analytic system: a. to check each batch of culture media plates used at the laboratory for selectivity and or inhibition and biochemical response since January 20, 2016. Refer to D5477. 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 quality control records review and laboratory director and testing personnel interview on January 25, 2018 at 11:55 AM, it was determined that laboratory director failed to ensure compliance with the requirements for analytic systems. The finding includes: 1. The laboratory director did not assure that the laboratory: a. to check each batch of culture media plates used at the laboratory for selectivity and or inhibition and biochemical response since Januuary 20, 2016. Refer to D5477. 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. This STANDARD is not met as evidenced by: Based on Quality Assessment (QA) records review and laboratory director and testing personnel interview on January 25, 2018 at 11:48 AM, it was determined that laboratory failed to ensure compliance with quality assessment (QA) requierements. The finding includes: 1. The laboratory did not evaluate the established Quality Asessment Program to monitor and evaluate the requirement for analytic systems. Refer to D5791. D6177 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(3) Each individual performing high complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and -- 2 of 3 -- procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on quality control records review and laboratory director and testing personnel interview on January 25, 2018 at 11:58 AM, it was determined that testing personnel failed to follow quality control procedures. The finding includes: 1. The laboratory testing personnel failed the following quality control procedures: a. to check each batch of culture media plates used at the laboratory for selectivity and or inhibition and biochemical response since January 20, 2016. Refer to D5477. -- 3 of 3 --