Laboratorio Clinico Barbosa

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at LABORATORIO CLINICO BARBOSA, INC. on October 10, 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 10, 2024. D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program (PRPTP) records review (years 2023-2024) and laboratory general supervisor interview at 10:00 AM on October 10, 2024, it was determined that the laboratory failed to participate in the hematology second testing event performed on June 2024. The findings include: 1. The Proficiency Testing Program scores were reviewed from February 2023 to August 2024. Reviewed on October 10, 2024 at 10:00 AM. 2. The records showed that the laboratory obtained, for the second testing event year 2024 a testing score of 0% for hematology specialty. Reviewed on October 10, 2024 at 10:15 AM. 3. During interview with the laboratoy supervisor she stated that the deadline of the second testing event report of hematology was June 21, 2024. Reviewed on October 10, 2024 at 10:20 AM. 4. The laboratory general supervisor confirmed on October 10, 2024 at 10:30 AM, that the laboratory failed to participate in the second testing event of hematology specialty in June 2024. D6090 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(ii) 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 -- The laboratory director must ensure the results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program (PRPTP) records review (years 2023-2024) and laboratory general supervisor interview on October 10, 20234 at 10: 00 AM, it was determined that the laboratory failed to send the results proficiency testing samples on time as required under Subpart H requirements. Refer to D2127. -- 2 of 2 --

Summary Statement of Deficiencies D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) records and laboratory testing personnel interview on November 8, 2022, it was found that the laboratory did not retain nor perform the evaluations of the Quality Assessment Program in order to monitor and evaluate the laboratory activities (pre-analytic, analytic and post-analytic systems) since year 2021. The findings include: 1. On November 8, 2022 at 11:43 AM, showed that the laboratory did not have any document related to the QA program for year 2021 nor year 2022. No QA procedure manual was found at the facility. 2. The laboratory testing personnel stated on November 8, 2022 at 11:55 AM, that the laboratory did not have available the Quality Assessment documentation in the laboratory since January 2021. 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 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 -- 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on COVID19 worklist, quality control records review from January 4, 2021 to March 5, 2021, manufacturer's instructions for COVID19 IgG / IgM (FaStep rapid test), COVID19 antigen (CareStart) and laboratory testing personnel interview on March 10, 2021 at 10:23 AM, it was determined that the laboratory failed to follow manufacturer's instructions for monitor and document the laboratory's room temperature and relative humidity. The findings include: 1. The laboratory used the FaStep Rapid Test Device for antibody (IgG / IgM) test kit and CareStart COVID19 for antigen test kit. 2. The manufacturer's instructions of the COVID19 antibody (FaStep Rapid Test Device) and COVID19 antigen (CareStart COVID19 antigen), stated that the laboratory monitor and document each day of use of COVID19 antibody and COVID19 antigen the room temperature and relative humidity. 3. Review of the COVID19 (antibody and antigen) quality control records, showed that the laboratory did not monitor and document the room temperature and relative humidity from January 4, 2021 to March 5, 2021. 4. The laboratory processed and reported 239 patient's tests by COVID19 antibody (FaStep Rapid testDevice) and 53 patient's tests by COVID19 antigen (CareStart) from January 4, 2021 to March 5, 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 -- 2021. 5. The testing personnel confirmed on March 10, 2021 at 10:23 AM, that the laboratory did not monitor and document the room temperatures and relative humidity those days. 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 COVID19 quality control records review from January 4, 2021 to March 5, 2021, manufacturer's instructions review and laboratory testing personnel interview on March 10, 2021 at 10:23 AM, it was determined that laboratory director failed to ensure compliance with the requirements for analytic systems. The finding includes: 1. The laboratory director did not assure that the laboratory: a. to follow manufacturer's instructions for monitor and document the laboratory's room temperature and relative humidity each day of use. Refer to D5413. -- 2 of 2 --

Summary Statement of Deficiencies D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on Detector manufacturer's instructions, mononucleosis (MONO) and C reactive protein (CRP) testing records review and testing personnel interview on November 9, 2018 at 10:50 AM, it was determined that the laboratory failed to failed to follow manufacturer's instruction when 4 patient's samples were tested and reported for negative results of Mono and CRP qualitative tests by the Detector methods from October 22, 2018 to October 28, 2018. The findings include: 1. The Detector manufacturer's instructed the laboratory to check all negative seras of CRP and Mono by retesting at 1:10 dilution due to a prozone phenomena. 2. On November 9, 2018 at 10:50 AM, the Detector /MONO testing records showed that the laboratory did not check 2 out of 2 patients specimens (negative seras) by retesting at 1:10 dilution before it reported as negative result: patient specimen #91409 on October 18, 2018 and patient specimen # 91603 on October 28, 2018. 3. On November 9, 2018 at 10:50 AM, the Detector /Crp testing records showed that the laboratory did not check 2 out of 2 patients specimens (negative seras) by retesting at 1:10 dilution before it reported as negative result: patient specimen #91496 on October 22, 2018 and patient specimen # 91376 on October 18, 2018. 4 . The testing personnel confirmed on November 9, 2018 at 10:50 AM, that the testing records showed that those specimens were not diluted. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) 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 -- 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 rheumatoid factor (RA) and C reactive protein (CRP) testing records review and testing personnel interview on November 9, 2018 at 10:50 AM, it was determined that the laboratory failed to include at least once a day, a negative and positive control materials when 2 out 2 patients specimens were tested for CRP qualitative test and 3 out 3 patients specimens were tested for RA qualitative tests from June 13, 2018 to December 18, 2017. The findings include: 1. On November 9, 2018 at 10:50 AM, the RA testing record showed that the laboratory did not include at least once a day, a negative and positive control materials when 3 out of 3 patients specimens were tested for RA qualitative tests from June 13, 2018 to October 28, 2018: patients specimens # 86874 and #86904 on June 13, 2018 and patient specimen # 91627 on October 28, 2018. 2. On November 9, 2018 at 10:50 AM, the CRP testing record showed that the laboratory did not include at least once a day, a negative and positive control materials when 2 out of 2 patients specimens were tested for CRP qualitative tests from December 18, 2017 to October 28, 2018: patient specimen # 80508 on December 18, 2017 and patient specimen # 91627 on October 28, 2018. 3. The testing personnel confirmed on November 9, 2018 at 10:50 AM, that the testing records of CRP and RA did not include the control procedures those days. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on Quality Assessment manual, quality assessment records review (2017-2018) and technical supervisor interview on November 9, 2018 12:30 PM, it was determined that the laboratory did not follow the established Quality Assessment Program to monitor and evaluate the patient tests results for inconsistencies with patient information from January 1, 2017 to November 8, 2018. The findings include: 1. The laboratory Quality Assessment manual showed that the laboratory designate a log sheet to document the patients tests results for inconsistencies with patient information. 2. The laboratory did not have quality assessment records to evaluate the patient tests results for inconsistencies with patient information from January 1, 2017 to November 8, 2018. 3. The technical supervisor confirmed that the laboratory did not document this assessment since January 2017. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of -- 2 of 4 -- 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 Detector manufacturer's instructions, mononucleosis (MONO), rheumatoid factor (RA) and C reactive protein (CRP) testing records review and testing personnel interview on November 9, 2018 at 10:50 AM, it was determined that technical consultant failed to comply with the requirements of the analytic systems for the general serology tests. Refer to D 5405 ( The laboratory did not follow manufacturer's instruction when 4 patient's samples were tested and reported for negative results of Mono and CRP qualitative tests by the Detector methods from October 22, 2018 to October 28, 2018.) Refer to D 5449 ( The laboratory did not include at least once a day, a negative and positive control materials when 2 out 2 patients specimens were tested for CRP qualitative test and 3 out 3 patients specimens were tested for RA qualitative tests from June 13, 2018 to December 18, 2017). D6021 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 quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on Quality Assessment manual, quality assessment records review (2017-2018) and technical supervisor interview on November 9, 2018 12:30 PM, it was determined that the laboratory director failed to ensure compliance with quality assessment requirements. Refer to D 5791 ( The laboratory did not follow the established Quality Assessment Program to monitor and evaluate the patient tests results for inconsistencies with patient information from January 1, 2017 to November 8, 2018). D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (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 Detector manufacturer's instructions, mononucleosis (MONO), rheumatoid factor (RA) and C reactive protein (CRP) testing records review and testing personnel interview on November 9, 2018 at 10:50 AM, it was determined that technical -- 3 of 4 -- consultant failed to ensure compliance with the requirements of the analytic systems for general serology tests. Refer to D 5405 ( The laboratory did not follow manufacturer's instruction when 4 patient's samples were tested and reported for negative results of Mono and CRP qualitative tests by the Detector methods from October 22, 2018 to October 28, 2018.) Refer to D 5449 ( The laboratory did not include at least once a day, a negative and positive control materials when 2 out 2 patients specimens were tested for CRP qualitative test and 3 out 3 patients specimens were tested for RA qualitative tests from June 13, 2018 to December 18, 2017). 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 Detector manufacturer's instructions, mononucleosis (MONO), rheumatoid factor (RA) and C reactive protein (CRP) testing records review and testing personnel interview on November 9, 2018 at 10:50 AM, it was determined that the testing personnel failed to follow quality control procedures for the general serology tests. Refer to D 5405 ( The laboratory did not follow manufacturer's instruction when 4 patient's samples were tested and reported for negative results of Mono and CRP qualitative tests by the Detector methods from October 22, 2018 to October 28, 2018.) Refer to D 5449 ( The laboratory did not include at least once a day, a negative and positive control materials when 2 out 2 patients specimens were tested for CRP qualitative test and 3 out 3 patients specimens were tested for RA qualitative tests from June 13, 2018 to December 18, 2017). -- 4 of 4 --