Summary:
Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA Recertification survey at the CDT Centro Medico Diagnostico Munoz Rivera on August 6, 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 August 6, 2025. D2081 GENERAL IMMUNOLOGY CFR(s): 493.837(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 (PRPT) event (years 2024-2025), CASPER Report 0155D scores, Proficiency Testing Service Program 2024 Schedule and laboratory technical consultant interview on August 6, 2025, at 9:53 A.M., it was determined that the laboratory failed to report the general immunology proficiency testing results within the time frame established by the program. The findings include: 1. The CASPER Report 0155D scores were reviewed offsite on August 1, 2025, at 9: 30 A.M. 2. The Proficiency Testing Service Program 2024 Schedule, showed that the deadline of the second testing event for general immunology was September 27, 2024. (Reviewed offsite on on August 1, 2025, at 9:35 A.M.) 3. The laboratory obtained a score of 0% in the second testing event for general immunology scores. (Reviewed on August 6, 2025, at 9:42 A.M.) 4. The laboratory technical consultant confirmed on August 6, 2025, at 9:53 A.M., that the laboratory failed to report the general immunology proficiency testing results of the second testing event within the time frame established by the PRPT. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the chemistry Diuri CS-T-240 instrument performance verification results, maintenance and quality control records and laboratory technical consultant interview on August 6, 2025 at 11:07 AM, it was determined that the laboratory failed to review and evaluate the instrument's verification performance prior to initiate patient testing on April 1, 2025. The findings include: 1. During interview with laboratory technical consultant on August 6, 2025 at 10:35 AM, she stated that the Diuri CS-T-240 instrument was put in place on April 2025. 2. On August 6, 2025 at 11:19 AM the maintenance records and quality control records show that the laboratory began to use the Diuri CS-T-240 instrument on April 1, 2025. 3. On August 6, 2025 at 10:57 AM, review of the chemistry Diuri CS-T-240 instrument performance verification results was evaluated and signed by the laboratory director on July 29, 2025. 4. The laboratory technical consultant confirmed on August 6, 2025 at 11:07 AM that the laboratory did not evaluate and sign the performance verification of the chemistry Diuri CS-T-240 instrument prior to put in place. 5. The laboratory processed and reported 255 patient samples on the chemistry Diuri CS-T-240 instrument from April 1, 2025 to July 29, 2025. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on review of the chemistry quality control records (year 2024-2025) and interview with the laboratory technical consultant on August 6, 2025 at 11:20 AM; it was determined that the laboratory director did not ensure that the verification of performance were evaluated and signed prior to put in place. D5421. 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 scores (year 2024-2025) and -- 2 of 3 -- CASPER Report 0155D scores, it was determined that the laboratory technical consultant failed to ensure that the laboratory participated in the second proficiency testing event of general immunology of the year 2024. Refer to D2081. -- 3 of 3 --