Laboratorio Clinico Pastillo

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at Laboratorio Clnico Pastillo on October 24, 2024. 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 October 24, 2024. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) 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 Human chorionic gonadotropin (hCG) test quality control records, patient test worksheet records review and interview with the laboratory supervisor on October 24, 2024 at 11:20 A.M., it was determined that the laboratory did not include an external positive and negative control material each day of hCG patient testing. From January 30, 2024 to September 16, 2024; when 62 out of 84 patients were processed and reported. The findings include: 1. Review of hCG quality control records and patient test worksheet records on October 24, 2024 at 11:00 A.M., showed that the laboratory did not include the external positive and negative control material each day of patient testing from January 30, 2024 to September 16, 2024. 2. The laboratory supervisor confirmed on October 24, 2024 at 11:20 A.M., that the laboratory failed to include a negative and positive external control material each day of patient testing. From January 30, 2024 to September 16, 2024; when 62 out of 84 patients were processed and reported. 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 -- 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 Human chorionic gonadotropin (hCG) quality control and patient test worksheet records review, and laboratory supervisor interview on October 24, 2024 at 11:20 AM, it was determined that the laboratory director did not ensure to include a positive and a negative control material each day of patient testing for hCG tests. Refer to D5449. -- 2 of 2 --

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (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 routine chemistry quality control records reviewed, laboratory director and general supervisor interview at 11:30 AM; it was determined that the laboratory failed to perform at least every 6 months the calibration verification procedures for the Lipid Panel performed in the Daytona analyzer by Randox. The findings include: a. On November 22, 2022 at 10:00 AM, the quality control records showed that the 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 -- laboratory did not perform at least every 6 months the calibration verification procedures for the Lipid Panel tests by the Daytona system. The quality control showed that the las linearity verification was on november 16, 2022. b. The calibration verification before november 16, 2022 was requested. The laboratory general supervisor confirmed on november 22, 2022 at 10:13 am that the calibration verification from January 2022 to November 2022 was not available. 2. The laboratory general supervisor and laboratory director confirmed on November 22, 2022, that the only records for the calibration verification procedures of those tests were performed on november 16, 2022. 3. The laboratory processed and reported 3,120 out of 3,120 Lipid Panel tests by the Daytona system from January 1, 2022 to November 15, 2022. 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 routine chemistry quality control records reviewed and laboratory director interview on November 22, 20212 at 12:00 PM, it was found that the laboratory director did not assure that quality control procedures related to calibration verification procedures were followed. Refer to D5439. -- 2 of 2 --