Immuno Reference Lab

Summary Statement of Deficiencies D0000 A Proficiency Test (PT) Desk Review off site survey was performed on June 2, 2025 to Laboratorio Clinico Immuno Reference Lab, 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 proficiency testing records (years 2024-2025) and Casper Report 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 -- 0155D scores, it was determined that the laboratory failed an unsuccessful participation in a Proficiency Testing Program for toxicology subspecialties. Refer to D2118. D2118 TOXICOLOGY CFR(s): 493.845(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 proficiency testing records (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 the toxicology tests. The finding includes: 1.. The Puerto Rico Proficiency Testing and Casper Report 0155D scores, showed that the laboratory obtained the following unsuccessful scores: Analyte: Carbamazepine a.. Third testing event year 2024 - 60% b. First testing event year 2025 - 60% 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 proficiency testing records (years 2024-2025) 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 toxicology 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 review of proficiency testing records (years 2024-2025) and Casper Report 0155D scores, it was determined that the laboratory director did not ensure that the laboratory has a satisfactory participation for toxicology test during the third testing event 2024 and first testing event 2025. Refer to D2118 -- 2 of 2 --

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of referred samples log sheets review and interview with the laboratory director, it was determined that the laboratory did not ensure the proper conditions of specimen transportation. The findings include: a. On 6/23/2022 at 1:57 PM, the logsheet used to document the samples collected at the referral laboratories were reviewed. The laboratory carriers must document the following information: arrival hour to the referral laboratory, departure hour, number of samples stored at room temperature, refrigerated or frozen, total of samples collected and the portable refrigerators temperatures. b. Review of the laboratory logsheet routes on 6/23/2022 at 2:00 pm, showed that on 6/21/2022 and 6/22/2022 none of the carriers documented the temperatures of any of the portable refrigerators. A total of twelve different routes were reviewed. c. The laboratory director was interviewed on 6/23/2022 at 2:15 pm, about the findings, and she stated that a route supervisor was in charge of the evaluations of the logsheets , but no remedial action was taken about the temperature missing values. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on lack of IQ 200 calibration records, IQ200 system procedures manual review and general supervisor interview on June 23, 2022, it was determined that the laboratory failed to perform at least every 30 days the calibration of the IQ 200 system for the urinalysis microscopic exams from January 2021 to June 23, 2022. The findings include: 1. The laboratory processed and reported the urine microscopic exams by the IQ 200 system. 2. On June 23, 2022 at 12:38 PM, the procedures manual was reviewed, it establishes that the calibration of the IQ 200 system must be performed every 30 days. 3. On June 23, 2022 at 1:18 PM, the IQ 200 calibration records were requested, however, the laboratory did not have available the calibration records for the IQ 200 system from January 2021 to June 23, 2022. 4. On June 23, 2022 at 2:42 PM, the general supervisor confirmed that the IQ 200 calibration records were not available. 5. The laboratory processed and reported 24,288 patients specimens for urine microscopic exam by the IQ 200 system from January 2021 to June 23, 2022. D5783

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 Anti-HCV package insert review and interview with the laboratory supervisor on June 12, 2019, it was determined that the laboratory failed to meet the analytic requirements in the subspecialty of general immunology (Anti-HCV). The finding includes: a. The laboratory did not established the performance characteristics of the Anti-HCV test for the following populations: newborns, infants, children, or populations of immunocompromised or immunosuppressed patients. Refer to D 5423. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. 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 STANDARD is not met as evidenced by: Based on review of the Abbott Architect Anti-HCV package, Architect instrument verification of performance specifications review and interview with the laboratory supervisor on June 12, 2019 at 12:15 PM, it was determined that the laboratory did not established the performance specifications of the Anti-HCV test for which the laboratory did not provide performance specifications. The findings include: a. The laboratory processed the Anti-HCV test by the Abbott Architect instrument. b. The Anti-HCV package insert in the intended use section showed the following: " Assay performance characteristics have not been established for newborns, infants, children , or populations of immunocompromised or immunosuppressed patients. The user is responsible for establishing their own assay performance characteristics in these populations." c. Review of the verification of performance characteristics performed by the laboratory showed that the laboratory did not verify the performance characteristics of the infants, children , nor populations of immunocompromised or immunosuppressed patients. d. The laboratory supervisor stated on June 12, 2019 that the laboratory performed Anti-HCV tests on infants, children and populations of immunocompromised or immunosuppressed patients. e. The laboratory workload from June 2018 to June 2019 for Anti-HCV were the following: 552 pediatric patients samples and 1,294 immunocompromised patient samples. 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 the verification of the performance specifications of the Anti- HCV test performed by the Abbott Architect instrument and interview with the laboratory supervisor on June 122, 2019, it was determined that the laboratory failed to fulfill her responsibilities and duties to ensure compliance with the laboratory analytical system for the subspecialty of general immunology . Refer to D 6086 (the laboratory director did not established the performance specifications of the modified Anti-HCV test) D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on review of the verification of the performance specifications of the Anti- HCV tests performed by the Abbott Architect instrument and interview with the laboratory supervisor on June 12, 2019 at 12: 20 PM, it was determined that the laboratory director did not ensure that the verification performance specifications were performed for the following patients populations prior to reporting patient tests reports: newborns, infants, children and immunocompromised or immunosuppressed patients. Refer to D 5423 -- 2 of 2 --