Summary:
Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at Laboratorio Clinico Bella Vista on November 5, 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 5, 2025. D2071 SYPHILIS SEROLOGY CFR(s): 493.835(c) (c) 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 0155D, PRPTSP 2024 Schedule and laboratory director interview on November 5, 2025, at 9:18 A.M., it was determined that the laboratory failed to report the syphilis serology 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 syphilis serology in the 2024 year. (Reviewed on November 4, 2025, at 2:32 P.M.) 2. The PRPTSP 2024 Schedule, showed that the deadline of the third testing event for syphilis serology scores was December 20, 2024. (Reviewed on November 4, 2025, at 2:35 P.M.) 3. The laboratory director confirmed on November 5, 2025, at 9: 18 A.M, that the laboratory failed to report the syphilis serology proficiency testing results of the third testing event within the time frame established by the PRPTSP. D6017 LABORATORY DIRECTOR RESPONSIBILITIES 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 -- CFR(s): 493.1407(e)(4)(ii) (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 5, 2025, at 9:18 A.M, it was determined that the laboratory director failed to ensure that the laboratory techical consultant submitted the syphilis serology proficiencies testing results within the time frame established by the program. Refer to D6041. 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 PRPTSP (year 2024-2025) and CASPER Report 0155D event scores, it was determined that the technical consultant failed to ensure that the laboratory achieved satisfactory participation in the third proficiency testing of syphilis serology event of the year 2024. Refer to 2071. -- 2 of 2 --