Summary:
Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA Recertification survey at the Laboratorio Clnico Salimar on June 24, 2025. 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 June 24, 2025. D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) (d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing (PRPTP) scores (year 2025), CASPER Report 0155D scores and laboratory technical consultant interviewed on June 24, 2025 at 11:10 AM, it was determined that the laboratory failed to participate in the routine chemistry first testing event performed on February 2025. The findings include: 1. The proficiency testing records were reviewed from January 2023 to April 2025. Reviewed on June 24, 2025 at 10:30 AM. 2. The laboratory did not participate in the first testing event for routine chemistry (routine chemistry, urinalysis, urine sediment) performed in February 2024, a testing score of 0 % was obtained. Review on June 24, 2025 at 11:00 AM. 3. The deadline of the first testing event report of routine chemistry was February 21, 2025. 4 The laboratory technical consultant confirmed on June 24, 2025 at 11:10 AM, that the laboratory failed to participate in the first testing event of routine chemistry specialty on February 2025. D2104 ENDOCRINOLOGY CFR(s): 493.843(d) 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 -- (d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing (PRPTP) scores (year 2025), CASPER Report 0155D scores and laboratory technical consultant interviewed on June 24, 2025 at 11:10 AM, it was determined that the laboratory failed to participate in the endocrinology first testing event performed on February 2025. The findings include: 1. The proficiency testing records were reviewed from January 2023 to April 2025. Reviewed on June 24, 2025 at 10:30 AM. 2. The laboratory did not participate in the first testing event for endocrinology (human chorionic gonadrotopin (hCG), thyroid stimulating hormone (TSH), thyroxine (T4), triiodothyronine (T3), Folate and Free T4 (thyroxine) performed in February 2025, a testing score of 0 % was obtained. Review on June 24, 2025 at 11:00 AM. 3. The deadline of the first testing event report of endocrinology was February 21, 2025. 4 The laboratory technical consultant confirmed on June 24, 2025 at 11:10 AM, that the laboratory failed to participate in the first testing event of endocrinology subspecialty on February 2025. D6041 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(3) (b)(3) Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered; This STANDARD is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing (PRPTP) scores (year 2025), CASPER Report 0155D scores and laboratory technical consultant interviewed on June 24, 2025 at 11:10 AM, it was determined that the laboratory director failed to ensure that the technical consultant would participate during the first testing event of year 2025 of proficiency testing sample. Refer to D2093 and D2104. -- 2 of 2 --