Laboratorio Clinico Garnier Guaynabo

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at Laboratorio Clinico Garnier Guaynabo on May 28, 2026. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following standard level deficiencies were found during the recertification CLIA survey ending on May 28, 2026. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on hematology calibration verification records review (years 2024 - 2026), and laboratory director interview on May 28, 2026 at 10:44 AM, the laboratory did not 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 -- perform, at least every 6 months, the calibration verification procedures for the hematology tests processed by the Sysmex KX-21N Analyzer, when the laboratory processed and reported 4,154 out of 4,154 Complete Blood Count (CBC) hematology tests from March 2, 2024 to May 28, 2026. The findings include: 1. The laboratory used the Sysmex KX-21N Analyzer to perform hematology Complete Blood Count (CBC) tests. 2. On May 28, 2026 at 10:39 AM, review of the hematology calibration verification records (years 2024 - 2026), showed that the laboratory did not perform the calibration verification procedure since March 2, 2024. 3. The laboratory director confirmed on May 28, 2026 at 10:44 AM, that the calibration verification was not performed every six months, since March 2, 2024 to May 28, 2026, when the laboratory processed and reported processed and reported 4,154 out of 4,154 CBC hematology tests from March 2, 2024 to May 28, 2026. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) activities records (years 2025-2026) and interview with the laboratory director on May 28, 2026 at 11:50 AM, the laboratory failed to evaluate and monitor the analytic laboratory systems related to: test procedures, test systems, equipment, instruments, reagents, materials, supplies for accuracy and reliability, specimen and reagent storage conditions, instrument and test system maintenance and function checks, establishment and verification of method performance specifications, calibration and calibration verification, control procedures, comparison of test results,

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (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 lack of Mycoplasma pneumoniae IgM test performance verification and laboratory supervisor interview on May 29, 2024 at 12:45 P.M., it was determined that the laboratory failed to evaluate the performance verification of the Mycoplasma pneumoniae IgM test. The laboratory processed and reported 144 patient samples from January 1, 2023 to May 29, 2024. The findings include: 1. On May 29, 2024 at 12:45 P.M., the Mycoplasma pneumoniae IgM test performance verification was requested, and the laboratory supervisor stated that the laboratory did not evaluate the performance verification of the system prior to begin to test patient samples. 2. The laboratory supervisor stated on May 29, 2024 at 12:49 P.M., that the laboratory acquired the Mycoplasma pneumoniae IgM test system since January 1, 2023. 3. The laboratory supervisor confirmed on May 29, 2024 at 12:53 P.M., that the laboratory did not have the performance verification of the Mycoplasma pneumoniae IgM test. 4. The laboratory processed and reported 144 Mycoplasma pneumoniae IgM patient samples from January 1, 2023 to May 29, 2024. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) 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 -- Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Mycoplasma pneumoniae IgM test quality control and patient test worksheet records review and laboratory supervisor interview on May 29, 2024 at 12:16 P.M., it was determined that the laboratory did not include an external positive and negative control material each day of Mycoplasma pneumoniae IgM patient testing, neither documented the internal control with each external control. The laboratory processed and reported a total of 144 Mycoplasma pneumoniae IgM test patients. The findings include: 1. The laboratory used the GenBio ImmunoWELL Mycoplasma pneumoniae IgM kit to perform patient Mycoplasma pneumoniae IgM tests. 2. Review of Mycoplasma pneumoniae IgM quality control and patient test worksheet records on May 29, 2024 at 12:16 P.M., showed that the laboratory did not include an external positive and negative control material each day of patient testing, neither documented the internal control with each external control.from January 1, 2023 to May 29, 2024, when the laboratory processed and reported a total of 144 patients. 3. The laboratory supervisor confirmed on May 29, 2024 at 12:21 P.M., that the laboratory failed to include a negative and positive control material each day of patient testing, and failed to document the internal control results with each external control. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on lack of Mycoplasma pneumoniae IgM test performance verification and laboratory supervisor interview on May 29, 2024 at 12:45 P.M., it was determined that the laboratory director failed to fulfill her responsibility to perform, evaluate and sign the performance verification of the new Mycoplasma pneumoniae IgM test. Refer to D5421. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control 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 Mycoplasma pneumoniae IgM test quality control and patient test worksheet records review and laboratory supervisor interview on May 29, 2024 at 12:16 P.M., it was determined that the laboratory director did not make sure to include a positive and -- 2 of 3 -- a negative control material each day of patient testing for Mycoplasma pneumonia tests, neither documented the internal control of each external control. Refer to D5449. -- 3 of 3 --