Summary:
Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA Recertification survey at the Laboratorio Clnico Dr Basora on November 12, 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 November 12, 2025. D2127 HEMATOLOGY CFR(s): 493.851(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 Service Program (PRPTSP) (years 2024-2025) and Certification and Survey Provider Enhanced Report (CASPER), Report 0155 D scores, PRPTSP 2024 schedule and laboratory director interview on November 12, 2025 at 9:28 A.M; it was determined that the laboratory filed to report the hematology proficiency testing results within the time frame established by the program. The findings include: 1. The PRPTSP and Casper Report were review and showed that the laboratory obtained 0% in the third testing event for hematology in the 2024 year. (Review on November 10, 2025 at 3:10 P.M.). 2. The PRPTSP 2024 schedule, showed that the deadline for the third testing event for hematology score was November 22, 2024. (Review on November 10, 2025 at 3:10 P. M.). 3. The laboratory director confirmed on November 12, 2025 at 9:28 A.M., that the laboratory failed to report the hematology proficiency testing results of the third testing event within the time frame established by the PRPTSP. D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) 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 -- (e)(4)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program; This STANDARD is not met as evidenced by: Based on PRPTSP (years 2024-2025), CASPER Report and laboratory director interview on November 12, 2025, at 9:28 A.M, it was determined that the laboratory director failed to ensure that the laboratory submitted the hematology proficiencies testing results within the time frame established by the program. Refer to D2127. -- 2 of 2 --