Laboratorio Clinico Central Ii

Summary Statement of Deficiencies D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on general immunology (Covid 19 IgG/IgM) quality control records (from October 14, 2020 to April 21, 2021) review and laboratory testing personnel interview on April 22, 2021 at 10:30 AM, it was determined that the laboratory failed to ensure compliance with the analytic system requirements of General immunology. The finding includes: 1. The laboratory did not include each day of testing a negative and a positives control materials when patients serum specimens were tested for qualitative Covid 19 IgG/IgM by the Clarity Coviblock method. Refer to D 5449. 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 quality control records review (from October 14, 2020 to April 21, 2021) and laboratory testing personnel interview on April 22, 2021 at 10: 30 AM, it was determined that the laboratory failed to include each day of testing a 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 -- negative and a positive control materials when 34 out of 37 days when patients specimens were tested and reported for qualitative Covid 19 IgG / IgM tests from October 14, 2020 to April 21, 2021 by the Clarity Coviblock method. The findings include: 1. The laboratory uses Clarity Coviblock method to perform Covid 19 IgG /IgM patient's samples tests. 2. On April 22, 20201 at 10:30 AM, the general immunology quality control records showed that the laboratory did not include each day of testing the negative nor the positive control materials from October 14, 2020 to April 21, 2021. 3. The laboratory does not include the negative and a positive control material in the following days: Date # patient's samples 10/14/2020 1 10/15/2020 1 10 /20/2020 2 10/21/2020 1 10/27/2020 1 10/30/2020 1 11/3/2020 2 11/6/2020 2 11/7 /2020 4 11/10/2020 1 11/12/2020 2 11/16/2020 3 11/17/2020 1 11/20/2020 4 11/23 /2020 2 12/1/2020 1 12/3/2020 1 12/4/2020 2 12/5/2020 1 12/8/2020 1 12/15/2020 2 12/17/2020 7 1/7/2021 3 1/13/2021 1 1/14/2021 1 1/20/2021 1 1/25/2021 1 2/2/2021 1 3/1/2021 2 3/10/2021 1 3/19/2021 1 3/26/2021 1 3/30/2021 1 4/8/2021 1 4/9/2021 2 4. The laboratory testing personnel on April 22, 2021 at 10:30 AM, confirmed that the laboratory did not include the negative not the positive control materials each day testing from October 14, 2020 to April 21, 2021. 4. The laboratory processed and reported sixty (60) patient's specimens for qualitative Covid 19 IgG/IgM tests from October 14, 2020 to April 21, 2021 by the Clarity Coviblock method. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on general immunology quality control records (from October 14, 2020 to April 21, 2021), manufacturer's instructions review and testing personnel interview on April 22, 2021 at 10:30 AM, it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory analytical system and quality assessment requirements. The finding includes: 1. The laboratory director did not comply with the requirement for analytical systems. Refer to D 6020. 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: Based on general immunology quality control records review (from October 14, 2020 to April 21, 2021) and laboratory testing personnel interview on April 22, 2021 at 10: 30 AM, it was determined that the laboratory director to ensure compliance with the requirements for analytic systems. Refer to D5449. The finding includes: 1. The -- 2 of 3 -- laboratory failed to include each day of testing a negative and a positive control materials when 34 out of 37 days when patients specimens were tested and reported for qualitative Covid 19 IgG / IgM tests from October 14, 2020 to April 21, 2021 by the Clarity Coviblock method. D6072 TESTING PERSONNEL RESPONSIBILITIES 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 general immunology quality control records review (from October 14, 2020 to April 21, 2021) and laboratory testing personnel interview on April 22, 2021 at 10: 30 AM, it was determined that testing personnel failed to follow quality control procedures. Refer to D5449. The finding includes: 1. The laboratory failed to include each day of testing a negative and a positive control materials when 34 out of 37 days when patients specimens were tested and reported for qualitative Covid 19 IgG / IgM tests from October 14, 2020 to April 21, 2021 by the Clarity Coviblock method. -- 3 of 3 --

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on observation, patient's final tests results records (years 2017-2019), CLIA Certificate of Compliance review, reference laboratory patient's tests review and laboratory director interview on April 10, 2019 at 11:00 AM, it was found that the laboratory processed and reported a patient sample for HA1C (glycosylate haemoglobin) although the laboratory was not certified for routine chemistry subspecialty. The findings include: 1.Review of patient's results records from May 2017 to February 2019, showed a patient result JMNG (Id #002237-000) with HA1C in 6.00% on September 10, 2018 at 10:08 AM. This sample was taken on September 10, 2018 at 6:52 AM. 2.Review of the CLIA Certificate of Compliance showed that the laboratory was not certified to perform routine chemistry tests. 3.The laboratory director stated during interview on April 10, 2019 at 11:00 AM that the laboratory reported a patient sample for HA1C (JMNG Id #002237-000) on September 11, 2018 at 10:08 AM for Dimension Xpand Plus chemistry instrument. 4.The instrument Dimension Xpand Plus was observed at the facility, the laboratory director stated on April 10, 2019 at 11:00 AM that the laboratory did not perform routine chemistry patient's samples tests since August 2016. 5.This laboratory refers patient's samples from tests that do not perform in their laboratory to Laboratorio Clnico de Referencia 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 -- M. Landrn, Inc. 6.Review the lists of samples referred to the reference laboratory on September 10, 2018, the laboratory no evidence was found that this test was referred to the Laboratorio Clnico de Referencia M. Landrn, Inc. For that patient JMNG on September 10, 2018 only the following tests were reported CMP (Comprehensive Metabolic Panel), Lipid panel, Microalbumin y TSH (Thyroid Stimulating Hormone). 7.The laboratory did not perform the daily preventive maintenance of the Dimension Xpand Plus routine chemistry instrument. 8.The laboratory did not perform the daily quality control of the Dimension Xpand Plus routine chemistry instrument. (HA1C) 9. The laboratory did not participate in a Puerto Rico Proficiency Testing Program for this test. (HA1C) D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on quality assessment (QA) records review (years 2017-2019) and laboratory director interview on April 10, 2019 at 11:00 AM, it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the requirement for post-analytic systems. (test report) The findings include: 1. Review of the laboratory quality assessment manual showed that the laboratory establishes twice a year assessment for each post-analytic system process to keep track the laboratory performance. 2. From May 2017 to March 2018, showed that the laboratory processed and reported a patient sample for HA1C (glycosylate haemoglobin) although the laboratory was not certified for routine chemistry subspecialty. Refer to D5805. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment 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 Quality Assessment (QA) records review (years 2017-2019) and laboratory director interview at 11:00AM on April 10, 2019, it was determined that laboratory director failed to ensure compliance with quality assessment (QA) requirements. Refer to DD5891. -- 2 of 2 --