Laboratorio Clinico Jollymar

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 Jollymar on June 12, 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 June 12, 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 Certification And Survey Provider Enhanced Reports (CASPER) 0155D and Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2024 - 2026), Hematology Proficiency Testing (PT) scores (year 2025), and laboratory general supervisor (GS) interview on June 12, 2026, at 10:15 a.m., the laboratory failed to evaluate the accuracy of patient testing for the Hematology specialty (Complete Blood Count (CBC) and White Blood Cell (WBC) 5-Parameter testing), when the PT provider assigned an artificial score of 100 percent. The laboratory processed and reported 3,227 out of 3,227 patient test results from March 2025 through November 2025. The findings include: 1. CASPER and PRPTSP (hematology PT) scores were reviewed from May 2024 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-Parameter; and 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 third testing event in 2025 showed that the PT provider assigned an artificial score of 100 percent for CBC and WBC 5-Parameter. The results were not evaluated. 3. During interview on June 12, 2026, at 10:17 a.m., with the GS, the evaluation of the accuracy of the excused Hematology specialty (Complete Blood Count (CBC) and White Blood Cell (WBC) 5- Parameter) was required. 4. The laboratory processed and reported 3,227 out of 3,227 patient samples from March 2025 through November 2025. 5. The GS stated on June 12, 2026, at 10:26 a.m., that the laboratory did not evaluate the accuracy of the Hematology specialty test. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

Summary Statement of Deficiencies D0000 T he laboratorio Clnico Jolly Mar was found to be in substantial compliance with CLIA regulations (42 CFR Part 493, effective April 24, 2003). No deficiencies were cited as a result of an onsite survey performed on February 4, 2021. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on test report records review and testing personnel interview on February 4, 2021 at 1:00 PM, it was determined that the laboratory failed to report the SARS-Co- VIRAL RNA test results as required for 2 out of 10 days reviewed from January 5, 2021 to February 2, 2021. The findings include: 1. The laboratory utilized the Health Department written instruction to reports the SARS-Co-VIRAL RNA by the Bioportal. 2. The laboratory processed the SARS-Co-VIRAL RNA tests by the ID Now system. 3. The test report records showed that 2 out of 10 days from January 5, 2021 to February 2, 2021, the laboratory did not report the SARS-Co-VIRAL RNA negative results in the required frequency (24 hrs) by the Bioportal: Date Patients Date tested specimens reported 01/29/2021 16 02/01/2021 01/30/2021 7 02/01/2021 4. The testing personnel confirmed on February 4, 2021 at 1:00 PM that those negative results of SARS-Co-VIRAL RNA tests were not reported in 24 hrs. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --