Laboratorio Clinico Luquillo

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on August 3, 2026 to Laboratorio Clnico Luquillo, 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 (year 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 -- 2026), the laboratory failed to achieve satisfactory performance (80% or better) for two (2) out of two (2) consecutive testing events for the subspecialty of endocrinology in the analyte T3 Uptake tests. Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 Certification And Survey Provider Enhanced Reports (CASPER) 0155D and Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (year 2026), the laboratory failed to achieve satisfactory performance (80% or better) for two (2) out of two (2) consecutive testing events for the subspecialty of endocrinology in the analyte T3 Uptake tests. The findings include: 1. Review of the Casper Report 0155D and PRPTSP scores on August 3, 2026, confirmed that the laboratory had a PT (Proficiency Test) failure for the analyte T3 Uptake tests in the subspecialty of endocrinology. The laboratory obtained the following testing scores: Analyte: T3 Uptake a. First testing event year 2026 - 0% b. Second testing event year 2026 - 0% 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 (year 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 (year 2026), the laboratory director failed to ensure successful participation in an HHS- approved proficiency testing program. Refer to D2107. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at Laboratorio Clinico Luquillo on June 18, 2026. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following standard level deficiencies were found during the recertification CLIA survey ending on June 18, 2026. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2025 - 2026), Certification and Survey Provider Enhanced Reports (CASPER Report 0155D) scores, hematology Proficiency Testing (PT) scores (year 2025) and laboratory director interview on June 18, 2026, at 11:02 AM; the laboratory failed to evaluate the accuracy of testing in the hematology specialty, when the laboratory received an artificial score of 100 percent from the PT provider on the 2025 third event (November 2025). The laboratory processed and reported 2,493 Complete Blood Count (CBC) hematology patient samples from June 2025 through June 18, 2026. The findings include: 1. The CASPER Report 0155D scores were reviewed on June 18, 2026 at 11:00 AM, and showed that the laboratory received 100 percent score in the hematology third event of 2025 (November 2025). 2. PRPTSP were reviewed from February 2025 through June 2026. 3. Review of the hematology PT scores for the third testing event in 2025 showed that the PT provider assigned an artificial score of 100 percent. The results were not evaluated. 4. During interview 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 -- with the laboratory director on June 18, 2026, at 11:02 AM; the accuracy of the excused 2025 hematology specialty PT third event (Complete Blood Count - (CBC) and White Blood Cell (WBC) 5 Parameters) was required. The laboratory director stated that no procedure for accuracy evaluation was performed. 5. The laboratory director also stated on June 18, 2026, at 11:07 AM, that no written procedure was developed by the laboratory to evaluate the accuracy of tests not evaluated by the PT provider. 6. From June 2025 through June 18, 2026, the laboratory processed and reported 2,493 hematology CBC patient samples. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require