Laboratorio Clinico Dr Cajigas

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on May 14, 2026 to Laboratorio Clnico Dr. Cajigas, 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 2025-2026), the laboratory failed to achieve satisfactory performance (80% or better) for two (2) out of two (2) consecutive testing events for the subspecialty of routine 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 -- chemistry in the analyte for Gamma Glutamyl Transferase (GGT) tests. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 (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 subspecialty of routine chemistry in the analyte Gamma Glutamyl Transferase (GGT) tests. The findings include: 1. Review of the Casper Report 0155D and PRPTSP scores on May 10, 2026, confirmed that the laboratory had a PT (Proficiency Test) failure for the analyte Gamma Glutamyl Transferase (GGT) tests in the subspecialty of routine chemistry. The laboratory obtained the following testing scores: Analyte: Gamma Glutamyl Transferase (GGT) a. Third testing event year 2025 - 40% b. First testing event year 2026 - 20% 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 D2096. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on personnel records review (yars 2021-2023) and laboratory director interview on June 6, 2023 at 11:30 AM, it was determined that the laboratory failed to follow the established schedule for personnel competence evaluation. The findings include: 1. The laboratory schedule for testing personnel and clinical consultant competence evaluation showed that it must be performed every year. 2. The laboratory did not perform the annual evaluation of the clinical consultant- MD #10738 since year 2021. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on personnel records review (years 2021-2023) and laboratory diretor interview on June 6, 2023 at 11:30 AM, it was determined that the laboratory failed to follow the established schedule for clinical consultant evaluation. The findings include: 1. The laboratory schedule for clinical consultant competence evaluation showed that it 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 -- must be performed every year. 2. The laboratory did not perform the clinical consultant competence evaluation since year 2021. 3. The director confirmed on June 6, 2023 at 11:30 AM that the competence evaluation were not performed as established. -- 2 of 2 --