Laboratorio Clinico Metropolis

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on daily checks records of temperatures (years 2022 and 2023) and interview with the laboratory director on September 13, 2023 at 11:15 AM; it was determined that the laboratory failed to monitor and document the freezer temperature where the laboratory keeps patient samples that will be referred to another laboratory to be processed. The findings include: 1. On September 13, 2023 at 11:00 AM; the daily checks were reviewed and showed that the freezer temperature was not available. The freezer was inspected and there was no thermometer there at the time of inspection. 2. On September 13, 2023 at 11:15 AM; the laboratory director stated that they only use the freezer to keep the samples that will be referred to another laboratory to be processed and confirmed that there was no thermometer inside. Also the laboratory director confirmed that the laboratory failed to monitor and document the frezeer temperature (years 2022 and 2023). 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 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 -- 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 by Immunocard) quality control records review (years 2022-2023) and laboratory director interview on September 13, 2023 at 11:57 AM, it was determined that the laboratory did not include an external positive and negative control material each day of Mycoplasma pneumoniae patient testing. From January 14, 2023 to September 12, 2023 the laboratory process and report 299 out of 307 patient samples. The findings include: 1. General Immunology (Mycoplasma pneumoniae test) quality control records was review on September 13, 2023 at 11:33 AM, and showed that the laboratory did not include the external positive and negative control material each day of patient testing since January 14, 2023. 2. The laboratory director confirmed on September 13, 2022 at 11:57 AM, that the laboratory failed to include a external negative and positive control material each day of patient testing. From January 14, 2023 to September 12, 2023 the laboratory process and report 299 out of 307 patient samples. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: 1. Based on Mycoplasma pneumoniae quality control records review years 2022 and 2023, and interview with the laboratory director on September 13, 2023 at 11:57 AM, it was determined that the laboratory director (sole personnel) fail to establish the quality control program of the Mycoplasma pneumoniae tests. Refer to D5449. 2. Based on daily checks records years 2022 and 2023 and interview with the laboratory director on September 13, 2023 at 11:15 AM, it was determined that the laboratory director failed to established a range of temperature for freezer where the laboratory keeps patient samples that will be referred to another laboratory to be processed. Refer to 5311. -- 2 of 2 --

Summary Statement of Deficiencies 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 COVID 19 test report, Puerto Rico Department of Health (PRDOH) COVID 19 state reporting requirement and laboratory director interview on November 10, 2021 at 10:38 AM, it was determined that the laboratory did not follow the state COVID 19 test reporting requirements. The findings include: 1. The PRDOH requires that all COVID 19 tests report must be informed within 24 hours of the final report, to the Bio Portal platform. 2. The laboratory used the Healgen rapid test for antibody (IgG / IgM) test kit, CareStart COVID 19 for antigen test kit and Id Now (Abbott) for molecular COVID 19 test. 3. The test report records showed that 31 out of 31 days from September 22, 2021 to November 8, 2021. The laboratory did not report the SARS-CoV-IgG / IgM patients results in the required frequency (24 hrs) by the Bio Portal: Date Patients Date tested specimens reported 09/22/2021 2 09/27/2021 09/23 /2021 1 09/27/2021 09/24/2021 2 09/27/2021 09/25/2021 3 09/27/2021 09/27/2021 1 10/04/2021 09/30/2021 1 10/04/2021 10/02/2021 5 10/04/2021 10/04/2021 1 10/11 /2021 10/05/2021 2 10/11/2021 10/06/2021 1 10/11/2021 10/09/2021 5 10/11/2021 10 /11/2021 1 10/18/2021 10/12/2021 1 10/18/2021 10/12/2021 1 10/18/2021 10/13/2021 2 10/18/2021 10/14/2021 2 10/18/2021 10/15/2021 1 10/18/2021 10/16/2021 9 10/18 /2021 10/18/2021 3 10/26/2021 10/19/2021 1 10/26/2021 10/20/2021 1 10/26/2021 10 /22/2021 2 10/26/2021 10/23/2021 5 10/26/2021 10/25/2021 3 10/26/2021 10/28/2021 1 11/09/2021 10/30/2021 2 11/09/2021 11/02/2021 4 11/09/2021 11/03/2021 1 11/09 /2021 11/04/2021 1 11/09/2021 11/05/2021 2 11/09/2021 11/06/2021 2 11/09/2021 Total of report greater than 24 hours: 70 reports. 4. The test report records showed that 18 out of 21 days from December 8, 2020 to February 17, 2021. The laboratory did not report the SARS-CoV- antigen patients results in the required frequency (24 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- hrs) by the Bio Portal: Date Patients Date tested specimens reported 09/13/2021 12 09 /22/2021 09/14/2021 12 09/22/2021 09/15/2021 9 09/22/2021 09/16/2021 2 09/22 /2021 09/17/2021 13 09/22/2021 09/18/2021 13 09/22/2021 09/20/2021 6 09/22/2021 09/22/2021 9 09/27/2021 09/23/2021 8 09/27/2021 09/24/2021 12 09/27/2021 09/25 /2021 12 09/27/2021 09/27/2021 9 10/04/2021 09/28/2021 7 10/04/2021 09/29/2021 14 10/04/2021 09/30/2021 7 10/04/2021 10/01/2021 10 10/04/2021 10/02/2021 15 10 /04/2021 10/04/2021 6 10/11/2021 10/05/2021 7 10/11/2021 10/06/2021 13 10/11 /2021 10/07/2021 14 10/11/2021 10/08/2021 9 10/11/2021 10/09/2021 17 10/11/2021 10/11/2021 7 10/18/2021 10/12/2021 9 10/18/2021 10/13/2021 12 10/18/2021 10/14 /2021 10 10/18/2021 10/15/2021 11 10/18/2021 10/16/2021 26 10/18/2021 10/18 /2021 11 10/26/2021 10/19/2021 14 10/26/2021 10/20/2021 7 10/26/2021 10/21/2021 7 10/26/2021 10/22/2021 3 10/26/2021 10/23/2021 9 10/26/2021 10/26/2021 3 11/09 /2021 10/27/2021 5 11/09/2021 10/28/2021 5 11/09/2021 10/29/2021 14 11/09/2021 10/30/2021 14 11/09/2021 11/01/2021 11 11/09/2021 11/02/2021 4 11/09/2021 11/03 /2021 4 11/09/2021 11/04/2021 5 11/09/2021 11/05/2021 18 11/09/2021 11/06/2021 8 11/09/2021 Total of report greater than 24 hours: 660 reports. 5. The test report records showed that 17 out of 17 days from December 12, 2020 to January 19, 2021. The laboratory did not report the SARS-CoV- molecular (ID NOW) patients results in the required frequency (24 hrs) by the Bio Portal: Date Patients Date tested specimens reported 09/22/2021 9 no fecha de envi 09/23/2021 7 no fecha de envi 09/24/2021 13 no fecha de envi 09/25/2021 5 no fecha de envi 09/27/2021 8 10/04/2021 09/28/2021 5 10/04/2021 09/29/2021 6 10/04/2021 09/30/2021 3 10/04/2021 10/01/2021 2 10/04 /2021 10/02/2021 7 10/04/2021 10/04/2021 5 10/11/2021 10/05/2021 4 10/11/2021 10 /06/2021 2 10/11/2021 10/07/2021 1 10/11/2021 10/08/2021 1 10/11/2021 10/09/2021 2 10/11/2021 10/11/2021 7 10/18/2021 10/12/2021 4 10/18/2021 10/13/2021 7 10/18 /2021 10/14/2021 2 10/18/2021 10/15/2021 1 10/18/2021 10/16/2021 5 10/18/2021 10 /18/2021 4 10/26/2021 10/19/2021 6 10/26/2021 10/20/2021 7 10/26/2021 10/21/2021 2 10/26/2021 10/22/2021 9 10/26/2021 10/23/2021 7 10/26/2021 10/26/2021 4 11/09 /2021 10/27/2021 4 11/09/2021 10/28/2021 9 11/09/2021 10/29/2021 5 11/09/2021 10 /30/2021 6 11/09/2021 11/02/2021 10 11/09/2021 11/03/2021 10 11/09/2021 11/04 /2021 4 11/09/2021 11/05/2021 2 11/09/2021 11/06/2021 5 11/09/2021 Total of report greater than 24 hours: 263 reports. 4. The laboratory general supervisor confirmed on February 19, 2021 at 10:10 AM, that the before mentioned tests were not reported within the 24 hours of the final test report. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies 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 COVID 19 test report, Puerto Rico Department of Health (PRDOH) COVID 19 state reporting requirement and laboratory director interview on November 10, 2021 at 10:38 AM, it was determined that the laboratory did not follow the state COVID 19 test reporting requirements. The findings include: 1. The PRDOH requires that all COVID 19 tests report must be informed within 24 hours of the final report, to the Bio Portal platform. 2. The laboratory used the Healgen rapid test for antibody (IgG / IgM) test kit, CareStart COVID 19 for antigen test kit and Id Now (Abbott) for molecular COVID 19 test. 3. The test report records showed that 31 out of 31 days from September 22, 2021 to November 8, 2021. The laboratory did not report the SARS-CoV-IgG / IgM patients results in the required frequency (24 hrs) by the Bio Portal: Date Patients Date tested specimens reported 09/22/2021 2 09/27/2021 09/23 /2021 1 09/27/2021 09/24/2021 2 09/27/2021 09/25/2021 3 09/27/2021 09/27/2021 1 10/04/2021 09/30/2021 1 10/04/2021 10/02/2021 5 10/04/2021 10/04/2021 1 10/11 /2021 10/05/2021 2 10/11/2021 10/06/2021 1 10/11/2021 10/09/2021 5 10/11/2021 10 /11/2021 1 10/18/2021 10/12/2021 1 10/18/2021 10/12/2021 1 10/18/2021 10/13/2021 2 10/18/2021 10/14/2021 2 10/18/2021 10/15/2021 1 10/18/2021 10/16/2021 9 10/18 /2021 10/18/2021 3 10/26/2021 10/19/2021 1 10/26/2021 10/20/2021 1 10/26/2021 10 /22/2021 2 10/26/2021 10/23/2021 5 10/26/2021 10/25/2021 3 10/26/2021 10/28/2021 1 11/09/2021 10/30/2021 2 11/09/2021 11/02/2021 4 11/09/2021 11/03/2021 1 11/09 /2021 11/04/2021 1 11/09/2021 11/05/2021 2 11/09/2021 11/06/2021 2 11/09/2021 Total of report greater than 24 hours: 70 reports. 4. The test report records showed that 18 out of 21 days from December 8, 2020 to February 17, 2021. The laboratory did not report the SARS-CoV- antigen patients results in the required frequency (24 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- hrs) by the Bio Portal: Date Patients Date tested specimens reported 09/13/2021 12 09 /22/2021 09/14/2021 12 09/22/2021 09/15/2021 9 09/22/2021 09/16/2021 2 09/22 /2021 09/17/2021 13 09/22/2021 09/18/2021 13 09/22/2021 09/20/2021 6 09/22/2021 09/22/2021 9 09/27/2021 09/23/2021 8 09/27/2021 09/24/2021 12 09/27/2021 09/25 /2021 12 09/27/2021 09/27/2021 9 10/04/2021 09/28/2021 7 10/04/2021 09/29/2021 14 10/04/2021 09/30/2021 7 10/04/2021 10/01/2021 10 10/04/2021 10/02/2021 15 10 /04/2021 10/04/2021 6 10/11/2021 10/05/2021 7 10/11/2021 10/06/2021 13 10/11 /2021 10/07/2021 14 10/11/2021 10/08/2021 9 10/11/2021 10/09/2021 17 10/11/2021 10/11/2021 7 10/18/2021 10/12/2021 9 10/18/2021 10/13/2021 12 10/18/2021 10/14 /2021 10 10/18/2021 10/15/2021 11 10/18/2021 10/16/2021 26 10/18/2021 10/18 /2021 11 10/26/2021 10/19/2021 14 10/26/2021 10/20/2021 7 10/26/2021 10/21/2021 7 10/26/2021 10/22/2021 3 10/26/2021 10/23/2021 9 10/26/2021 10/26/2021 3 11/09 /2021 10/27/2021 5 11/09/2021 10/28/2021 5 11/09/2021 10/29/2021 14 11/09/2021 10/30/2021 14 11/09/2021 11/01/2021 11 11/09/2021 11/02/2021 4 11/09/2021 11/03 /2021 4 11/09/2021 11/04/2021 5 11/09/2021 11/05/2021 18 11/09/2021 11/06/2021 8 11/09/2021 Total of report greater than 24 hours: 660 reports. 5. The test report records showed that 17 out of 17 days from December 12, 2020 to January 19, 2021. The laboratory did not report the SARS-CoV- molecular (ID NOW) patients results in the required frequency (24 hrs) by the Bio Portal: Date Patients Date tested specimens reported 09/22/2021 9 no fecha de envi 09/23/2021 7 no fecha de envi 09/24/2021 13 no fecha de envi 09/25/2021 5 no fecha de envi 09/27/2021 8 10/04/2021 09/28/2021 5 10/04/2021 09/29/2021 6 10/04/2021 09/30/2021 3 10/04/2021 10/01/2021 2 10/04 /2021 10/02/2021 7 10/04/2021 10/04/2021 5 10/11/2021 10/05/2021 4 10/11/2021 10 /06/2021 2 10/11/2021 10/07/2021 1 10/11/2021 10/08/2021 1 10/11/2021 10/09/2021 2 10/11/2021 10/11/2021 7 10/18/2021 10/12/2021 4 10/18/2021 10/13/2021 7 10/18 /2021 10/14/2021 2 10/18/2021 10/15/2021 1 10/18/2021 10/16/2021 5 10/18/2021 10 /18/2021 4 10/26/2021 10/19/2021 6 10/26/2021 10/20/2021 7 10/26/2021 10/21/2021 2 10/26/2021 10/22/2021 9 10/26/2021 10/23/2021 7 10/26/2021 10/26/2021 4 11/09 /2021 10/27/2021 4 11/09/2021 10/28/2021 9 11/09/2021 10/29/2021 5 11/09/2021 10 /30/2021 6 11/09/2021 11/02/2021 10 11/09/2021 11/03/2021 10 11/09/2021 11/04 /2021 4 11/09/2021 11/05/2021 2 11/09/2021 11/06/2021 5 11/09/2021 Total of report greater than 24 hours: 263 reports. 4. The laboratory general supervisor confirmed on February 19, 2021 at 10:10 AM, that the before mentioned tests were not reported within the 24 hours of the final test report. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)