Lab Cl Centro De Diagnostico Y Tratamiento

Summary Statement of Deficiencies 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 endocrinology quality control records review ( years 2021-2023 ), patient's reports worksheets review and laboratory general supervisor interview on February 7, 2023 at 10:45 AM, it was determined that the laboratory failed to include a negative and positive control material each day of testing when reported and performed hCG test 13 out of 368 patient's samples in 7 out of 217 days. The findings include : 1. The laboratory performed hCG ( human chorionic gonadotropin) by Alere one step method. Review on February 7, 2023 at 10:45 AM. 2. Endocrinology quality control logs and patient's reports worksheets were reviewed from November 1, 2022 to February 6, 2023. Review on February 7, 2023 at 10:50 AM. 3. The endocrinology quality control logs and patient's reports worksheets records showed that the laboratory did not include a negative and positive control material each day of testing from April 24, 2022 to October 27, 2022, when peformed and reported 13 patient's samples in the following days: (reviewed on February 7, 2023 at 10:53 AM) Date hCG patient's samples 4/24/2022 1 6/11/2023 3 7/21/2022 2 10/20/2022 1 10/21/2022 4 10/25/2022 1 10/27/2022 1 4. The laboratory general supervisor confirmed on February 7, 2023 at 10:55 a.m. , that the laboratory failed to include a negative and positive control material each day of testing when performed hCG test. D6072 TESTING PERSONNEL 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): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on endocrinology quality control records review (years 2021-2023), patient's reports worksheets review and laboratory general supervisor interview on February 7, 2023 at 10:45 AM, it was determined that testing personnel failed to follow quality control procedures. Refer to D5449. 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 endocrinology quality control records review (years 2021-2023), patient's reports worksheets review and laboratory general supervisor interview on February 7, 2023 at 10:45 AM, it was determined that the laboratory director failed to maintain the quality control procedures for hCG test 13 out of 368 patient's samples in 7 out of 217 days by Alere One Step Method. The finding include: 1. The laboratory failed to include a negative and positive control material each day of testing when reported and performed hCG test 13 out of 368 patient's samples in 7 out of 217 days. Refer to D5449. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on endocrinology quality control records review (years 2021-2023), patient's reports worksheets review and laboratory general supervisor interview on February 7, 2023 at 10:45 AM, it was determined that the general supervisor did not assure that quality control procedures were followed by the testing personnel. Refer to D5449. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratorio Clnico CDT Rio Grande 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 a remote survey process performed on April 20, 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 general supervisor interview on April 20, 2021 at 1:55 PM it was determined that the laboratory failed to report the Covid- 19 results as required for 3 out of 11 days reviewed from February 1, 2021 to February 12, 2021 . The findings include: 1. The laboratory utilized the Health Department written instruction to reports the Covid-19 results to the Bioportal. 2. The laboratory processed the Covid-19 antigen test by Quidel method and the Covid-19 rapid test by Healgen method. 3. The report records showed that the laboratory performed the Covid-19 antigen test from February 1, 2021 to February 5, 2021; the laboratory did not report the Covid-19 results in the required frequency (24 hrs) to the Bioportal in one out of 5 days: Date Patients Date tested specimens reported tested 02/03/2021 20 02/05/2021 3. The report records showed that the laboratory performed the Covid-19 rapid test from February 5, 2021 to February 12, 2021; the laboratory did not report the Covid-19 results in the required frequency (24 hrs) to the Bioportal in 2 out of 7 days: Date Patients Date tested specimens reported tested 02/05/2021 1 02/08/2021 02 /10/2021 6 02/12/2021 4. The laboratory general supervisor confirmed on February 20, 2021 at 1:55 PM, that those results of Covid-19 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 --