Laboratorio Clinico Renacer,Llc

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 General Immunology (Mycoplasma pneumoniae test) quality control records review (years 2021 and 2022) and interview with the laboratory technical supervisor on October 12, 2022 at 11:20 AM, it was determined that the laboratory did not include each day of testing an external positive and negative control material when seven out of seven patients specimens were tested and reported for Mycoplasma pneumoniae patient testing from September 9, 2022 to September 22, 2022. The findings include: 1. The laboratory use the Immuno Card Mycoplasma Test Cassette to perform the Mycoplasma pneumoniae qualitative tests. 2 . On October 12, 2022 at 11:20 AM, review of Mycoplasma pneumoniae quality control and patient results record showed that the laboratory did not include each day of testing the external control materials when it performs the following patients specimens from September 9, 2022 to September 22, 2022: Date Patient ID 09/09/2022 # 16126 09/10/2022 # 16130 09/12/2022 # 16143 09/13/2022 # 16165 09/15/2022 # 16191 09/15/2022 # 16192 09/22/2022 # 16227 3. On October 12, 2022 at 11:25 AM, the laboratory technical supervisor confirmed that the laboratory failed to include each day of testing the external negative and positive control material from September 9, 2022 to September 22, 202 . She stated that the laboratory run the internal control with each patients testing and run the external controls when it received this new reagent kit. 4. The laboratory processed and reported seven patient samples for Mycoplasma pneumoniae qualitative test from September 9, 2022 to September 22, 2022, 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 General Immunology (Mycoplasma pneumoniae test) quality control records review (years 2021 and 2022) and interview with the laboratory technical supervisor on October 12, 2022 at 11:20 AM, it was determined that the it was determined that the laboratory director failed to ensure that quality control procedures for Mycoplasma tests are maintained in the laboratory. Refer to D 5449 (The laboratory did not include every day of testing did not include each day of testing an external positive and negative control material when seven out of seven patients specimens were tested and reported for Mycoplasma pneumoniae test from September 9, 2022 to September 22, 2022). -- 2 of 2 --

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 qualitative Covid-19IgG/IgM rapid tests records review (years 2020 and 2021) and interview with the laboratory supervisor on February 24, 2021 at 9:50 AM, it was determined that the laboratory failed to include each day of testing a negative and a positive control materials when 844 out of 844 patient's specimens were tested and reported for qualitative Covid-19IgG/IgM rapid tests from November 1, 2020 to February 23, 2021 by the Healgen method. The findings include : 1. The Covid-19IgG /IgM testing records showed that the the laboratory did not include each day of testing a negative and a positive control materials when patient's specimens were tested for qualitative Covid-19IgG/IgM tests from November 1, 2020 to February 23, 2021. 2. The laboratory evaluate and documented the procedural control each day of testing from November 1, 2020 to February 23, 2021. 3. The general supervisor confirmed on February 24, 2021 at 9:50 AM (by telephone call), that the laboratory did not include the negative nor the positive control materials each day of qualitative Covid-19IgG /IgM testing. 4. The laboratory tested and reported 844 out of 844 patient's specimens for qualitative Covid-19IgG/IgM rapid tests from November 1, 2020 to February 23, 2021. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) 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 -- (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on qualitative Covid-19IgG/IgM rapid tests records review (years 2020 and 2021) and interview with the laboratory supervisor on February 24, 2021 at 9:50 AM, it was determined that technical consultant failed to ensure compliance with the requirements for analytic systems for the Covid-19IgG/IgM rapid tests from November 1, 2020 to February 23, 2021 Refer to D 5449 (The laboratory failed to include each day of testing a negative and a positive control materials when 844 out of 844 patient's specimens were tested and reported for qualitative Covid-19IgG/IgM rapid tests from November 1, 2020 to February 23, 2021 by the Healgen method). 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 qualitative Covid-19IgG/IgM rapid tests records review (years 2020 and 2021) and interview with the laboratory supervisor on February 24, 2021 at 9:50 AM, it was determined that the laboratory director failed to ensure compliance with the requirements for the Covid-19IgG/IgM rapid test from November 1, 2021 to February 23, 2021. Refer to D 5449 (The laboratory failed to include each day of testing a negative and a positive control materials when 844 out of 844 patient's specimens were tested and reported for qualitative Covid-19IgG/IgM rapid tests from November 1, 2020 to February 23, 2021 by the Healgen method). -- 2 of 2 --