Laboratorio Clinico Marie E

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced Clinical Laboratory Improvement Amendments (CLIA) recertification survey at Laboratorio Clnico Marie -E Inc. on May 14, 2026. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following standard level deficiencies were found during the unannounced routine CLIA recertification survey ending on May 14, 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), hematology Proficiency Testing (PT) scores (year 2025), and interview with the laboratory director on May 14, 2026, at 9:30 a.m., the laboratory failed to evaluate the accuracy of testing for the hematology specialty (Complete Blood Count (CBC) and White Blood Cell (WBC) 5-Parameters testing), when the laboratory received an artificially score of 100 percent from the PT provider. The laboratory processed and reported 11,887 patient samples from March 2025 through November 2025. The findings include: 1. PRPTSP and hematology PT scores were reviewed from February 2025 through March 2026. 2. Review of the hematology PT scores for the second testing event in 2025 showed that the PT provider assigned an artificial score of 100 percent in WBC 5-parameters; and the third testing event in 2025 showed that the PT provider assigned an artificial score of 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 -- 100 percent for CBC and WBC 5-Parameters. The results were not evaluated. 3. During interview on May 14,2026, at 10:05 a.m., with the laboratory director, the accuracy of the excused hematology specialty (Complete Cell Count - (CBC) and White Blood Cell (WBC) 5 Parameters) was required. The laboratory director stated that no procedure for accuracy evaluation was performed. 4. The laboratory director stated on May 14,2026, at 10:05 a.m., that the laboratory did not developed a written procedure to evaluate the accuracy of test not evaluated by the PT provider. 5. The laboratory processed and reported 11,887 patient samples from March 2025 through November 2025. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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 Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2025-2026), hematology proficiency testing (PT) scores (year 2025), laboratory policies and procedures, and interview with the laboratory director on May 14, 2026, at 2:00 p.m., the laboratory director failed to ensure that the technical supervisor evaluated the accuracy of hematology testing and the laboratory established a written procedure for the evaluation and follow-up of PT events not evaluated by the PT provider. Refer to: D5215. D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) (b)(2) Verification of the test procedures performed and establishment of the laboratorys test performance characteristics, including the precision and accuracy of each test and test system; This STANDARD is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing Service Program (PRPTSP) scores and interview with the laboratory director on May 14, 2026, at 2:00 p.m., the technical supervisor failed to fulfill her responsibilities and duties to ensure compliance with the hematology PT requirements. Refer to D5215. -- 2 of 2 --

Summary Statement of Deficiencies D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Human chorionic gonadotropin (hCG) manufacturer's instructions, worksheet records review and laboratory director interview on April 2, 2024 at 12:35 PM, it was determined that the laboratory failed to follow manufacturer's instructions to document the internal control each day of patient testing when processing hCG samples. The findings include: 1. The laboratory performed (hCG) human chorionic gonadotropin by OSOM hCG Combo Test kit. 2. Review of the manufacturer's instructions on April 2, 2024 at 12:30 PM showed that the laboratory must monitor and document the internal control to ensure the validity of the hCG test performed. 3. The hCG test worksheet records showed on April 2, 2024 at 12:35 PM, that the laboratory did not document the observed results of the internal procedural control with each day of patient testing when processing hCG samples. 4. The laboratory processed and reported 290 hCG patient samples from January 1, 2023 to April 2, 2024. 5. The laboratory director confirmed on April 2, 2024 at 12:40 PM, that the laboratory did not monitor and document the internal control with each day of patient testing when processing hCG samples. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established 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 -- 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 endocrinology quality control records review, it was determined that the laboratory director did not ensure that hCG quality control procedures were performed as established by the manufacturer's instructions. Refer to D5479. -- 2 of 2 --

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2082 GENERAL IMMUNOLOGY CFR(s): 493.837(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program (PRPTP) records review (year's 2016, 2017 and 2018) and laboratory director interview on May 3, 2018 at 9:25 AM, it was determined that the laboratory failed to take and document