Summary:
Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at Laboratorio Clnico Blasor. 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 August,22 2024. D2104 ENDOCRINOLOGY CFR(s): 493.843(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 Puerto Rico Proficiency Testing Program records reviewed ( years 2023- 2024) and laboratory general supervisor interview on August 22, 2024 at 9:30 A.M., it was determined that the laboratory failed to report the endocrinology proficiency testing results within the time frame established by the program. The findings include: 1. Proficiency testing records were reviewed on August 22, 2024 at 9:30 A.M., from February 2023 to June 2024. The deadline of the first testing event report of endocrinology was February 23, 2024. 2. The laboratory obtained a score of 0% in the first testing event report of endocrinology. ( Reviewed on August 22,2024 at 9:40 A. M.) 3. The laboratory general supervisor confirmed on August 22, 2024 at 9:45 A.M., that the laboratory failed to report the endocrinology proficiency testing results of the first testing event within the time frame established by the Proficiency Testing Program. D6090 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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 -- The laboratory director must ensure the results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program records review ( years 2023-2024 ) and laboratory general supervisor interview on August 22, 2024 at 10:00 A. M, it was determined that the laboratory director failed to report the endocrinology proficiency testing results within the time frame established by the program, getting a score of 0% in the first event for endocrinology. Refer to D 2104. -- 2 of 2 --